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-###24845963
-BACKGROUND	This study analyzed liver function abnormalities in heart failure patients admitted with severe acute decompensated heart failure ( ADHF ) .
-RESULTS	A post hoc analysis was conducted with the use of data from the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness ( ESCAPE ) .
-RESULTS	Liver function tests ( LFTs ) were measured at 7 time points from baseline , at discharge , and up to 6 months follow-up .
-RESULTS	Survival analyses were used to assess the association between admission Model of End-Stage Liver Disease Excluding International Normalized Ratio ( MELD-XI ) scores and patient outcome.There was a high prevalence of abnormal baseline ( admission ) LFTs ( albumin 23.8 % , aspartate transaminase 23.5 % , alanine transaminase 23.8 % , and total bilirubin 36.1 % ) .
-RESULTS	The percentage of patients with abnormal LFTs decreased significantly from baseline to 6-months ' follow-up .
-RESULTS	When mean hemodynamic profiles were compared in patients with abnormal versus normal LFTs , elevated total bilirubin was associated with a significantly lower cardiac index ( 1.80 vs 2.1 ; P < .001 ) and higher central venous pressure ( 14.2 vs 12.0 ; P = .03 ) .
-RESULTS	Multivariable analyses revealed that patients with elevated MELD-XI scores ( 16.8 ) had a 2-fold ( hazard ratio2 .06 , 95 % confidence interval 1.05-4 .03 ) increased risk of death , rehospitalization , or transplantation after adjusting for baseline LFTs , age , sex , race , body mass index , diabetes , and systolic blood pressure .
-CONCLUSIONS	Abnormal LFTs are common in the ADHF population and are a dynamic marker of an impaired hemodynamic state .
-CONCLUSIONS	Elevated MELD-XI scores are associated with poor outcomes among patients admitted with ADHF .
-
-###24469619
-BACKGROUND	Minimally invasive endovascular aneurysm repair ( EVAR ) could be a surgical technique that improves outcome of patients with ruptured abdominal aortic aneurysm ( rAAA ) .
-BACKGROUND	The aim of this study was to analyse the cost-effectiveness and cost-utility of EVAR compared with standard open repair ( OR ) in the treatment of rAAA , with costs per 30-day and 6-month survivor as outcome parameters .
-METHODS	Resource use was determined from the Amsterdam Acute Aneurysm ( AJAX ) trial , a multicentre randomized trial comparing EVAR with OR in patients with rAAA .
-METHODS	The analysis was performed from a provider perspective .
-METHODS	All costs were calculated as if all patients had been treated in the same hospital ( Onze Lieve Vrouwe Gasthuis , teaching hospital ) .
-RESULTS	A total of 116 patients were randomized .
-RESULTS	The 30-day mortality rate was 21 per cent after EVAR and 25 per cent for OR : absolute risk reduction ( ARR ) 44 ( 95 per cent confidence interval ( c.i. ) -110 to 197 ) per cent .
-RESULTS	At 6months , the total mortality rate for EVAR was 28 per cent , compared with 31 per cent among those assigned to OR : ARR 24 ( -142 to 190 ) per cent .
-RESULTS	The mean cost difference between EVAR and OR was 5306 ( 95 per cent c.i. -1854 to 12,659 ) at 30days and 10,189 ( -2477 to 24,506 ) at 6months .
-RESULTS	The incremental cost-effectiveness ratio per prevented death was 120,591 at 30days and 424,542 at 6months .
-RESULTS	There was no significant difference in quality of life between EVAR and OR .
-RESULTS	Nor was EVAR superior regarding cost-utility .
-CONCLUSIONS	EVAR may be more effective for rAAA , but its increased costs mean that it is unaffordable based on current standards of societal willingness-to-pay for health gains .
-
-###25552432
-BACKGROUND	Evidence suggests that individuals with social anxiety demonstrate vigilance to social threat , whilst the peptide hormone oxytocin is widely accepted as supporting affiliative behaviour in humans .
-METHODS	This study investigated whether oxytocin can affect attentional bias in social anxiety .
-METHODS	In a double-blind , randomized , placebo-controlled , within-group study design , 26 healthy and 16 highly socially anxious ( HSA ) male volunteers ( within the HSA group , 10 were diagnosed with generalized social anxiety disorder ) were administered 24 IU of oxytocin or placebo to investigate attentional processing in social anxiety .
-METHODS	Attentional bias was assessed using the dot-probe paradigm with angry , fearful , happy and neutral face stimuli .
-RESULTS	In the baseline placebo condition , the HSA group showed greater attentional bias for emotional faces than healthy individuals .
-RESULTS	Oxytocin reduced the difference between HSA and non-socially anxious individuals in attentional bias for emotional faces .
-RESULTS	Moreover , it appeared to normalize attentional bias in HSA individuals to levels seen in the healthy population in the baseline condition .
-RESULTS	The biological mechanisms by which oxytocin may be exerting these effects are discussed .
-CONCLUSIONS	These results , coupled with previous research , could indicate a potential therapeutic use of this hormone in treatment for social anxiety .
-
-###24321138
-BACKGROUND	Exposure to diesel exhaust causes inflammatory responses .
-BACKGROUND	Previous controlled exposure studies at a concentration of 300 g/m ( 3 ) of diesel exhaust particles mainly lasted for 1 h.
-BACKGROUND	We prolonged the exposure period and investigated how quickly diesel exhaust can induce respiratory and systemic effects .
-METHODS	Eighteen healthy volunteers were exposed twice to diluted diesel exhaust ( PM1 ~ 300 g/m ( 3 ) ) and twice to filtered air ( PM1 ~ 2 g/m ( 3 ) ) for 3 h , seated , in a chamber with a double-blind set-up .
-METHODS	Immediately before and after exposure , we performed a medical examination , spirometry , rhinometry , nasal lavage and blood sampling .
-METHODS	Nasal lavage and blood samples were collected again 20 h post-exposure .
-METHODS	Symptom scores and peak expiratory flow ( PEF ) were assessed before exposure , and at 15 , 75 , and 135 min of exposure .
-RESULTS	Self-rated throat irritation was higher during diesel exhaust than filtered air exposure .
-RESULTS	Clinical signs of irritation in the upper airways were also significantly more common after diesel exhaust exposure ( odds ratio = 3.2 , p < 0.01 ) .
-RESULTS	PEF increased during filtered air , but decreased during diesel exhaust exposure , with a statistically significant difference at 75 min ( +4 L/min vs. -10 L/min , p = 0.005 ) .
-RESULTS	Monocyte and total leukocyte counts in peripheral blood were higher after exposure to diesel exhaust than filtered air 20 h post-exposure , and a trend ( p = 0.07 ) towards increased serum IL-6 concentrations was also observed 20 h post-exposure .
-CONCLUSIONS	Diesel exhaust induced acute adverse effects such as symptoms and signs of irritation , decreased PEF , inflammatory markers in healthy volunteers .
-CONCLUSIONS	The effects were first seen at 75 min of exposure .
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-###25829103
-OBJECTIVE	Depressive disorders are one of the leading components of the global burden of disease with a prevalence of up to 14 % in the general population .
-OBJECTIVE	Numerous studies have demonstrated that pharmacotherapy combined with non-pharmacological measures offer the best treatment approach .
-OBJECTIVE	Psycho-education as an intervention has been studied mostly in disorders such as schizophrenia and dementia , less so in depressive disorders .
-OBJECTIVE	The present study aimed to assess the impact of psycho-education of patients and their caregivers on the outcome of depression .
-METHODS	A total of 80 eligible depressed subjects were recruited and randomised into 2 groups .
-METHODS	The study group involved an eligible family member and all were offered individual structured psycho-educational modules .
-METHODS	Another group ( controls ) received routine counselling .
-METHODS	The subjects in both groups also received routine pharmacotherapy and counselling from the treating clinician and were assessed at baseline , 2 , 4 , 8 , and 12 weeks using the Hamilton Depression Rating Scale ( HDRS ) , Global Assessment of Functioning ( GAF ) , and Psychological General Well-Being Index ( PGWBI ) .
-METHODS	Results from both groups were compared using statistical methods including Chi-square test , Fisher 's exact test , Student 's t test , Pearson 's correlation coefficient , as well as univariate and multiple regression analyses .
-RESULTS	Baseline socio-demographic and assessment measures were similar in both groups .
-RESULTS	The study group had consistent improvement in terms of outcome measures with HDRS , GAF , and PGWBI scores showing respective mean change of -15.08 , 22 , and 60 over 12 weeks .
-RESULTS	The comparable respective changes in the controls were -8.77 , 18.1 , and 43.25 .
-CONCLUSIONS	Structured psycho-education combined with pharmacotherapy is an effective intervention for people with depressive disorders .
-CONCLUSIONS	Psycho-education optimises the pharmacological treatment of depression in terms of faster recovery , reduction in severity of depression , and improvement in subjective wellbeing and social functioning .
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-###24756362
-OBJECTIVE	A pharmacokinetic substudy was conducted within a phase 3 clinical trial that evaluated the efficacy and safety of two leuprolide acetate 3-month depot formulations in children with central precocious puberty ( CPP ) , where the pharmacokinetics of leuprolide and the exposure-response relationship between leuprolide concentration and the probability of luteinizing hormone ( LH ) suppression were assessed .
-METHODS	Children diagnosed with CPP ( N = 42 in each dosing cohort ) , who were treatment nave or previously treated , received a total of two intramuscular injections of either leuprolide acetate depot 11.25 or 30 mg formulations administered 3 months apart .
-METHODS	Serial blood samples were collected for leuprolide concentration determination in a subset of subjects ( N = 24 in each cohort ) .
-METHODS	One-way analysis of covariance was used to assess dose proportionality .
-METHODS	The probability of LH suppression ( peak-stimulated LH concentrations < 4 mIU/mL ) exposure-response relationship was modelled using repeated measures logistic regression .
-METHODS	The predicted probability of LH suppression and the corresponding 95 % confidence interval at the mean leuprolide concentration of each dose group and at each time of measurement were computed .
-RESULTS	Mean leuprolide concentrations between weeks 4 and 12 for 11.25 and 30 mg doses were relatively constant and dose proportional , with no accumulation of leuprolide upon repeated administration .
-RESULTS	Body weight and age were not found to be significant covariates on leuprolide pharmacokinetics .
-RESULTS	Higher leuprolide concentrations were associated with higher probability of LH suppression and both doses provided LH suppression levels < 4 mIU/mL .
-CONCLUSIONS	Leuprolide pharmacokinetics were characterized for 11.25 and 30 mg 3-month depot injections .
-CONCLUSIONS	An exposure-response model was developed to link leuprolide concentrations and probability of peak-stimulated LH suppression .
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-###24553426
-OBJECTIVE	To determine whether alcohol consumption is causally associated with cognitive impairment in older men as predicted by mendelian randomization .
-METHODS	Retrospective analysis of a cohort study of 3,542 community-dwelling men aged 65 to 83 years followed for 6 years .
-METHODS	Cognitive impairment was established by a Mini-Mental State Examination score of 23 or less .
-METHODS	Participants provided detailed information about their use of alcohol during the preceding year and were classified as abstainers , occasional drinkers , and regular drinkers : mild ( < 15 drinks/wk ) , moderate ( 15-27 drinks/wk ) , heavy ( 28-34 drinks/wk ) , and abusers ( 35 drinks/wk ) .
-METHODS	We genotyped the rs1229984 GA variant of the alcohol dehydrogenase 1B ( ADH1B ) gene , which is associated with lower prevalence of alcohol abuse and dependence .
-METHODS	Other measures included age , education , marital status , smoking and physical activity , body mass index , diabetes , hypertension , and cardiovascular diseases .
-RESULTS	At study entry , rs1229984 GA polymorphism was associated with lower prevalence of regular use of alcohol and decreased consumption among regular users .
-RESULTS	Six years later , 502 men ( 14.2 % ) showed evidence of cognitive impairment .
-RESULTS	Abstainers and irregular drinkers had higher odds of cognitive impairment than regular drinkers ( odds ratio [ OR ] = 1.23 , 95 % confidence interval [ CI ] = 1.00-1 .51 , after adjustment for other measured factors ) .
-RESULTS	The rs1229984 GA polymorphism did not decrease the odds of cognitive impairment ( AA/GG OR = 1.35 , 95 % CI = 0.29-6 .27 ; GA/GG OR = 1.05 , 95 % CI = 0.71-1 .55 ) .
-CONCLUSIONS	Alcohol consumption , including heavy regular drinking and abuse , is not a direct cause of cognitive impairment in later life .
-CONCLUSIONS	Our results are consistent with the possibility , but do not prove , that regular moderate drinking decreases the risk of cognitive impairment in older men .
-
-###24656054
-BACKGROUND	Detoxification with psychosocial counseling remains a standard opioid-use disorder treatment practice but is associated with poor outcomes .
-BACKGROUND	This study tested the efficacy of a newly developed psychosocial intervention , Community Reinforcement Approach and Family Training for Treatment Retention ( CRAFT-T ) , relative to psychosocial treatment as usual ( TAU ) , for improving treatment outcomes .
-METHODS	A randomized , 14-week trial with follow-up visits at 6 and 9 months post-randomization conducted at two substance use disorder ( SUD ) treatment programs .
-METHODS	Opioid-dependent adults ( i.e. , identified patient - IP ) enrolled in a residential buprenorphine-detoxification program and their identified concerned significant other ( CSO ) was randomized to CRAFT-T ( n = 28 dyads ) or TAU ( n = 24 dyads ) .
-METHODS	CRAFT-T consisted of two sessions with the IP and CSO together and 10 with the CSO alone , over 14 weeks .
-METHODS	TAU for the CSOs was primarily educational and referral to self-help .
-METHODS	All IPs received treatment as usually provided by the SUD program in which they were enrolled .
-METHODS	The primary outcome was time to first IP drop from treatment lasting 30 days or more .
-METHODS	Opioid and other drug use were key secondary outcomes .
-RESULTS	CRAFT-T resulted in a moderate but non-significant effect on treatment retention ( p = 0.058 , hazard ratio = 0.57 ) .
-RESULTS	When the CSO was parental family , CRAFT-T had a large and significant effect on treatment retention ( p < 0.01 , hazard ratio = .040 ) .
-RESULTS	CRAFT-T had a significant positive effect on IP opioid and other drug use ( p < 0.0001 ) .
-CONCLUSIONS	CRAFT-T is a promising treatment for opioid use disorder but replication is needed to confirm these results .
-
-###24986061
-BACKGROUND	Characterization of the variations in the metabolomic profiles of elderly people is a necessary step to understand changes associated with aging .
-BACKGROUND	This study assessed whether diets with different fat quality and supplementation with coenzyme Q10 ( CoQ ) affect the metabolomic profile in urine analyzed by proton nuclear magnetic resonance spectroscopy from elderly people .
-METHODS	Ten participants received , in a cross-over design , four isocaloric diets for 4-week periods each : Mediterranean diet supplemented with CoQ ( Med + CoQ diet ) ; Mediterranean diet ; Western diet rich in saturated fat diet ; low-fat , high-carbohydrate diet enriched in n-3 polyunsaturated fat .
-RESULTS	Multivariate analysis showed differences between diets when comparing Med + CoQ diet and saturated fat diet , with greater hippurate urine levels after Med + CoQ diet and higher phenylacetylglycine levels after saturated fat diet in women .
-RESULTS	Following consumption of Med + CoQ , hippurate excretion was positively correlated with CoQ and - carotene plasma levels and inversely related to Nrf2 , thioredoxin , superoxide dismutase 1 , and gp91 ( phox ) subunit of NADPH oxidase gene expression .
-RESULTS	After saturated fat diet consumption , phenylacetylglycine excretion was inversely related to CoQ plasma level and positively correlated with isoprostanes urinary level .
-CONCLUSIONS	The association between hippurate excretion and antioxidant biomarkers along with the relationship between phenylacetylglycine excretion and oxidant biomarkers suggests that the long-term consumption of a Med + CoQ diet could be beneficial for healthy aging and a promising challenge in the prevention of processes related to chronic oxidative stress , such as cardiovascular and neurodegenerative disease .
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-###25233652
-OBJECTIVE	To compare the differences in the efficacy on lower limb motor function in children with spastic cerebral palsy between the combined therapeutic program of Jin three-needle therapy and MOTOmed intelligent motor training and the simple MOTOmed .
-METHODS	Eighty children with spastic cerebral palsy were randomized into an observation group and a control group , 40 cases in each group .
-METHODS	In the observation group , Jin three-needle therapy was used at four mind points , three brain points , three intelligent points , three temporal points , three knee points and three foot points , as well as Chengjin ( BL 56 ) , Chengshen ( BL 57 ) and the other .
-METHODS	Additionally , MOTOmed was given in assistance with conventional rehabilitation training .
-METHODS	In the control group , MOTOmed and the conventional rehabilitation training were adopted .
-METHODS	In the two groups , the treatment was given once a day , 20 treatments made one session and there were 3 to 5 days at interval between the two sessions .
-METHODS	The efficacy evaluation was performed after continuous 3 sessions of treatment .
-METHODS	The gross motor function measure ( GMFM ) and modified Ashworth scale ( MAS ) were applied for the evaluation before and after treatment in the two groups .
-RESULTS	After 3 sessions of treatment , GMFM score was increased apparently as compared with that before treatment in the two groups ( P < 0.01 , P < 0.05 ) .
-RESULTS	After treatment , GMFM score in the observation group was increased more remarkably than that in the control group ( 55.32 + / - 17.10 vs 47.48 + / - 17.18 , P < 0.05 ) .
-RESULTS	After treatment , the total effective rate of gastrocnemius Ashworth spasm grade [ 90.0 % ( 36/40 ) ] in the observation group was better apparently than [ 72.5 % ( 29/40 ) ] in the control group ( P < 0.05 ) .
-CONCLUSIONS	The combined therapeutic program of Jin three-needle therapy and MOTOmet intelligent motor training improves the lower limb motor function of the children with spastic cerebral palsy and its efficacy is better than simple MOTOmed .
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-###25453443
-BACKGROUND	Stenting is an alternative to endarterectomy for treatment of carotid artery stenosis , but long-term efficacy is uncertain .
-BACKGROUND	We report long-term data from the randomised International Carotid Stenting Study comparison of these treatments .
-METHODS	Patients with symptomatic carotid stenosis were randomly assigned 1:1 to open treatment with stenting or endarterectomy at 50 centres worldwide .
-METHODS	Randomisation was computer generated centrally and allocated by telephone call or fax .
-METHODS	Major outcomes were assessed by an independent endpoint committee unaware of treatment assignment .
-METHODS	The primary endpoint was fatal or disabling stroke in any territory after randomisation to the end of follow-up .
-METHODS	Analysis was by intention to treat ( [ ITT ] all patients ) and per protocol from 31 days after treatment ( all patients in whom assigned treatment was completed ) .
-METHODS	Functional ability was rated with the modified Rankin scale .
-METHODS	This study is registered , number ISRCTN25337470 .
-RESULTS	1713 patients were assigned to stenting ( n = 855 ) or endarterectomy ( n = 858 ) and followed up for a median of 42 years ( IQR 30-52 , maximum 100 ) .
-RESULTS	Three patients withdrew immediately and , therefore , the ITT population comprised 1710 patients .
-RESULTS	The number of fatal or disabling strokes ( 52 vs 49 ) and cumulative 5-year risk did not differ significantly between the stenting and endarterectomy groups ( 64 % vs 65 % ; hazard ratio [ HR ] 106 , 95 % CI 072-157 , p = 077 ) .
-RESULTS	Any stroke was more frequent in the stenting group than in the endarterectomy group ( 119 vs 72 events ; ITT population , 5-year cumulative risk 152 % vs 94 % , HR 171 , 95 % CI 128-230 , p < 0001 ; per-protocol population , 5-year cumulative risk 89 % vs 58 % , 153 , 102-231 , p = 004 ) , but were mainly non-disabling strokes .
-RESULTS	The distribution of modified Rankin scale scores at 1 year , 5 years , or final follow-up did not differ significantly between treatment groups .
-CONCLUSIONS	Long-term functional outcome and risk of fatal or disabling stroke are similar for stenting and endarterectomy for symptomatic carotid stenosis .
-BACKGROUND	Medical Research Council , Stroke Association , Sanofi-Synthlabo , European Union .
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-###24401580
-OBJECTIVE	To investigate the effect of central venous blood oxygen saturation ( ScvO2 ) and venous-arterial PCO2 ( P ( cv-a ) CO2 ) guided fluid therapy on tissue perfusion , gastrointestinal function recovering and outcome of the patients who undergoing open gastrointestinal surgery .
-METHODS	Forty patients undergoing open gastrointestinal surgery were randomly divided into 2 groups ( n = 20 each ) : ScvO2 guided fluid therapy ( group S ) and P ( cv-a ) CO2 guided fluid therapy ( group P ) .
-METHODS	All the patients were infused 10 ml/kg lactated Ringer 's ( LR ) solution before anesthesia induction , they were all also given a continuous lactated Ringer 's ( LR ) solution 's infusion at the speed of 2 mlkg ( -1 ) h ( -1 ) during the operation .
-METHODS	While , 6 % HES 130/0 .4 ( free flex 6 % HES 130/0 .4 , Fresenius Kabi ) infusion was different between the 2 groups , when the patients of group S 's central venous blood oxygen saturation < 75 % or venous-arterial PCO2 in the patients of P group 6 mm Hg , then infused 6 % HES 130/0 .4 .
-METHODS	Arterial and central venous blood gas analyses were performed every 20 minutes after skin incision , measure the venous and arterial lactate value , and record the anal exhaust time after surgery , postoperative complications and mortality in 28 days .
-RESULTS	Compared with group S , the arterial lactate value in T4 ( after operation began 80 min ) were significantly decreased in group P ( P = 0.013 ) , and venous lactate value in T5 ( after operation began 100 min ) were also lower ( P = 0.044 ) , other lactate value were not different ( P > 0.05 ) .
-RESULTS	The anal exhaust time was not different between the two groups ( P = 0.673 ) .
-RESULTS	All the patients were survival , and there were no obvious postoperative complications .
-CONCLUSIONS	Compared to group S , there was a transient improvement in tissue perfusion in group P , but there were no difference in complications and mortality .
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-###25311256
-OBJECTIVE	The study aim was to compare the efficacy and safety of ultrasound-guided intra-articular injections of hyaluronic acid and betamethasone in the management of patients with osteoarthritis of the thumb .
-METHODS	Eighty-eight evaluable patients diagnosed with osteoarthritis of the thumb ( Kellgren-Lawrence grade II-III ) received ultrasound-guided intra-articular treatment with hyaluronic acid ( 48 ) or betamethasone ( 40 ) .
-METHODS	In total , 3 local injections were scheduled at 7-day intervals .
-METHODS	Assessments were performed at baseline and at 7 , 14 , 30 , 90 , and 180 days .
-RESULTS	In both study groups , the pain Visual Analogue Scale and Functional Index for Hand Osteoarthritis scores decreased significantly during follow-up compared to baseline .
-RESULTS	There were no significant differences between the groups .
-RESULTS	However , at 90 days , the functional score showed a trend towards greater clinical improvement in the hyaluronic acid group ( P 0.071 ) .
-RESULTS	A subanalysis of patients with Functional Index score5 and Visual Analogue Scale score3 at baseline showed a significantly higher median functionality score in the hyaluronic acid group ( P 0.005 at 90 days and P 0.020 at 180 days ) .
-RESULTS	Further limiting analysis to a baseline pain score5 showed significantly greater improvement in functionality score ( P 0.004 at 180 days ) , which was already apparent after the second intra-articular injection at 14 days ( P 0.028 ) .
-RESULTS	In this patient subset , the mean pain score also improved significantly at 180 days ( P 0.02 ) .
-CONCLUSIONS	Both hyaluronic acid and betamethasone were effective and well-tolerated for the management of rhizarthrosis .
-CONCLUSIONS	Hyaluronic acid was more effective over time and more efficiently improved functionality and pain in patients with more severe symptoms .
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-###25428632
-BACKGROUND	The management of recurrent malignant pleural effusions ( MPE ) can be challenging .
-BACKGROUND	Various options are available , with the most efficacious and widely used being talc pleurodesis .
-BACKGROUND	Talc can either be applied via a chest drain in the form of slurry , or at medical thoracoscopy using poudrage .
-BACKGROUND	Current evidence regarding which method is most effective is conflicting and often methodologically flawed .
-BACKGROUND	The TAPPS trial is a suitably powered , multicentre , open-label , randomised controlled trial designed to compare the pleurodesis success rate of medical thoracoscopy and talc poudrage with chest drain insertion and talc slurry .
-METHODS	330 patients with a confirmed MPE requiring intervention will be recruited from UK hospitals .
-METHODS	Patients will be randomised ( 1:1 ) to undergo either small bore ( < 14Fr ) Seldinger chest drain insertion followed by instillation of sterile talc ( 4g ) , or to undergo medical thoracoscopy and simultaneous poudrage ( 4g ) .
-METHODS	The allocated procedure will be performed as an inpatient within 3days of randomisation taking place .
-METHODS	Following discharge , patients will be followed up at regular intervals for 6months .
-METHODS	The primary outcome measure is pleurodesis failure rates at 3months .
-METHODS	Pleurodesis failure is defined as the need for further pleural intervention for fluid management on the side of the trial intervention .
-BACKGROUND	The trial has received ethical approval from the National Research Ethics Service Committee North West-Preston ( 12/NW/0467 ) .
-BACKGROUND	There is a trial steering committee which includes independent members and a patient and public representative .
-BACKGROUND	The trial results will be published in a peer-reviewed journal and presented at international conferences , as well as being disseminated via local and national charities and patient groups .
-BACKGROUND	All participants who wish to know the study results will also be contacted directly on their publication .
-BACKGROUND	ISRCTN47845793 .
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-###24527713
-BACKGROUND	Reference values for plasma PTH assessment were generally established on small samples of apparently healthy subjects , without considering their 25-hydroxyvitamin D ( 25OHD ) status or other potential modifiers of PTH concentration .
-OBJECTIVE	Our objective was to assess ranges of plasma PTH concentration in a large sample of adults , stratifying by 25OHD status , age , gender , weight status , and calcium intake .
-METHODS	This cross-sectional survey is based on 1824 middle-aged Caucasian adults from the Supplmentation en Vitamines et Minraux Antioxydants study ( 1994 ) .
-METHODS	Plasma PTH and 25OHD concentrations were measured by an electrochemoluminescent immunoassay .
-METHODS	Extreme percentiles of plasma PTH concentrations were assessed specifically in subjects who had plasmatic values of 25OHD of 20 ng/mL or greater and 30 ng/mL or greater .
-RESULTS	Among subjects with 25OHD status of 20 ng/mL or greater , the 97.5 th percentile of plasma PTH concentration was 45.5 ng/L .
-RESULTS	By using this value as a reference , 5 % of the subjects with plasma 25OHD less than 20 nmol/L had a high plasma PTH level , reflecting secondary hyperparathyroidism .
-RESULTS	Among vitamin D-replete subjects ( 25OHD status of 20 ng/mL or greater ) , the 97.5 th percentile of plasma PTH was higher in overweight/obese subjects ( 51.9 vs 43.5 ng/L among normal weight subjects ) .
-CONCLUSIONS	The reference value for plasma PTH defined in this vitamin D-replete population was far below the value currently provided by the manufacturer ( 65 ng/L ) and varied according to overweight status .
-CONCLUSIONS	These results may contribute to improve the diagnosis of primary and secondary hyperparathyroidism and subsequent therapeutic indication .
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-###25661658
-BACKGROUND	Cytokine responses accompanying sublingual immunotherapy ( SLIT ) responder phenotypes have not previously been reported .
-OBJECTIVE	To investigate clinical and cytokine responses of house dust mite ( HDM ) sensitive patients with allergic rhinitis receiving HDM SLIT or placebo for 2 years .
-METHODS	Sixty adults were randomized to receive SLIT or placebo .
-METHODS	Clinical symptoms were measured using the Total 5 Symptom Score ( TSS5 ) and Juniper Rhinitis Quality of Life Questionnaire .
-METHODS	HDM specific IgE , IgG , skin prick tests , and HDM-stimulated release of interleukin ( IL ) 5 and interferon ( IFN - ) in peripheral blood mononuclear cells was studied at 0 , 6 , 12 , and 24 months and IL-13 , IL-4 , and IL-10 at 0 and 24 months .
-RESULTS	A total of 32 of 39 SLIT and 16 of 21 placebo patients completed the study .
-RESULTS	There was significant clinical improvement in both the SLIT and placebo groups .
-RESULTS	Median T5SS decreased from 14.75 to 5.25 in the SLIT group ( P < .001 ) and 12.7 to 6.0 in the placebo group ( P = .003 ) .
-RESULTS	The median quality-of-life score also decreased in the SLIT group ( P < .001 ) and the placebo group ( P < .001 ) .
-RESULTS	A subgroup analysis of patients found a 60 % or greater improvement ( on the T5SS and the Juniper Rhinitis Quality of Life Questionnaire ) in the good responders group and a 30 % to 59 % improvement or no improvement in the intermediate responders group .
-RESULTS	This subgroup analysis also found more good responders in the SLIT group ( 47 % ) compared with the placebo group ( 25 % ; P = .07 ) .
-RESULTS	Significant decreases in the IL-5 / IFN - ( P < .001 ) , IL-13 / IFN - ( P < .001 ) , and IL-4 / IFN - ( P = .03 ) ratios were found in the combined good clinical improvement group at 24 months .
-CONCLUSIONS	A good clinical response ( 60 % improvement in both TSS5 and quality of life ) is associated with significant decreases in IL-5 , IL-13 , and IL-4 relative to IFN - during 2 years of SLIT therapy for HDMs .
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-###25265132
-OBJECTIVE	The effects of combined oxycodone/naloxone prolonged release tablets ( OXN PR ) were investigated in patients with moderate-to-severe chronic cancer-related or non-cancer pain .
-OBJECTIVE	All patients had opioid-induced constipation ( OIC ) which persisted despite substantial laxative therapy .
-METHODS	This pooled analysis included 75 patients with OIC at study entry that was refractory to at least two laxatives with different modes of action .
-METHODS	Patients completed randomized , double-blind treatment with OXN PR 20-120mg / day for either 12 weeks ( OXN 9001 : non-cancer pain study ) or 4 weeks ( OXN 2001 : cancer-related pain study ) .
-METHODS	Analgesia and bowel function were assessed using the Brief Pain Inventory Short Form and Bowel Function Index ( BFI ) , respectively .
-METHODS	Use of laxative medication and safety were assessed throughout the studies .
-BACKGROUND	NCT00513656 , EudraCT 2005-002398-57 , EudraCT 2005-003510-15 .
-RESULTS	Statistically and clinically significant improvements in bowel function were observed following double-blind treatment with OXN PR .
-RESULTS	Mean ( SD ) reduction in BFI score was 21.2 ( 28.8 ) and comparable in patients with cancer-related ( 19.0 [ 28.9 ] ) and non-cancer pain ( 23.3 .
-RESULTS	[ 29.0 ] ; P0 .0002 ) .
-RESULTS	Furthermore , the proportion of patients with a BFI score within normal range ( 28.8 ) increased from 9.5 % at screening to 43.1 % at Day 15 of OXN PR .
-RESULTS	While all patients used 2 laxatives of different classes at screening , during study treatment 36 % stopped using laxatives ( P < 0.001 ) .
-RESULTS	OXN PR provided effective analgesia , evidenced by stable pain scores during study treatment , and there were no unanticipated adverse events .
-CONCLUSIONS	OXN PR significantly improved bowel function and reduced the use of laxatives in patients with OIC , previously unresponsive to at least two different classes of laxatives .
-CONCLUSIONS	OXN also provided effective analgesia for patients with moderate-to-severe cancer-related pain and non-cancer-related pain .
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-###24494281
-OBJECTIVE	To observe the difference in the clinical efficacy on oculomotor impairment between electroacupuncture and acupuncture and explore the best therapeutic method in the treatment of this disease .
-METHODS	Sixty cases of oculomotor impairment were randomized into an electroacupuncture group and an acupuncture group , 30 cases in each one .
-METHODS	In the electroacupuncture group , the points were selected on extraocular muscles , the internal needling technique in the eye was used in combination of electroacupuncture therapy .
-METHODS	In the acupuncture group , the points and needling technique were same as the electroacupuncture group , but without electric stimulation applied .
-METHODS	The treatment was given 5 times a week , 15 treatments made one session .
-METHODS	After 3 sessions of treatment , the clinical efficacy , palpebral fissure size , pupil size , oculomotor range and the recovery in diplopia were compared before and after treatment in the two groups .
-RESULTS	In the electroacupuncture group , the palpebral fissure size was ( 9.79 + / -2.65 ) mm and the eyeball shifting distance was ( 18.12 + / -1.30 ) mm , which were hig-her than ( 8.23 + / -2.74 ) mm and ( 16.71 + / -1.44 ) mm respectively in the acupuncture group .
-RESULTS	In the electroacupuncture group , the pupil diameter was ( 0.44 + / -0.42 ) mm , which was less than ( 0.72 + / - 0.53 ) mm in the acupuncture group , indicating the significant difference ( all P < 0.05 ) .
-RESULTS	The cured rate was 63.33 % ( 19/30 ) and the total effective rate was 93.33 % ( 28/30 ) in the electroacupuncture group , which was better than 36.67 % ( 11/30 ) and 83.333 ( 25/30 ) in the acupuncture group separately , indicating the significant difference ( all P < 0.05 ) .
-CONCLUSIONS	Electroacupuncture presents the obvious advantages in the treatment of oculomotor impairment , characterized as quick and high effect , short duration of treatment and remarkable improvements in clinical symptoms , there are important significance for the improvement of survival quality of patients .
-
-###24950759
-BACKGROUND	In this multi-country cluster-randomized behavioural intervention trial promoting exclusive breastfeeding ( EBF ) in Africa , we compared growth of infants up to 6months of age living in communities where peer counsellors promoted EBF with growth in those infants living in control communities .
-METHODS	A total of 82 clusters in Burkina Faso , Uganda and South Africa were randomised to either the intervention or the control arm .
-METHODS	Feeding data and anthropometric measurements were collected at visits scheduled 3 , 6 , 12 and 24weeks post-partum .
-METHODS	We calculated weight-for-length ( WLZ ) , length-for-age ( LAZ ) and weight-for-age ( WAZ ) z-scores .
-METHODS	Country specific adjusted Least Squares Means with 95 % confidence intervals ( CI ) based on a longitudinal analysis are reported .
-METHODS	Prevalence ratios ( PR ) for the association between peer counselling for EBF and wasting ( WLZ < -2 ) , stunting ( LAZ < -2 ) and underweight ( WAZ < -2 ) were calculated at each data collection point .
-RESULTS	The study included a total of 2,579 children .
-RESULTS	Adjusting for socio-economic status , the mean WLZ at 24weeks were in Burkina Faso -0.20 ( 95 % CI -0.39 to -0.01 ) and in Uganda -0.23 ( 95 % CI -0.43 to -0.03 ) lower in the intervention than in the control arm .
-RESULTS	In South Africa the mean WLZ at 24weeks was 0.23 ( 95 % CI 0.03 to 0.43 ) greater in the intervention than in the control arm .
-RESULTS	Differences in LAZ between the study arms were small and not statistically significant .
-RESULTS	In Uganda , infants in the intervention arm were more likely to be wasted compared to those in the control arm at 24weeks ( PR 2.36 ; 95 % CI 1.11 to 5.00 ) .
-RESULTS	Differences in wasting in South Africa and Burkina Faso and stunting and underweight in all three countries were small and not significantly different .
-CONCLUSIONS	There were small differences in mean anthropometric indicators between the intervention and control arms in the study , but in Uganda and Burkina Faso , a tendency to slightly lower ponderal growth ( weight-for-length z-scores ) was found in the intervention arms .
-BACKGROUND	ClinicalTrials.gov : NCT00397150 .
-
-###26135348
-BACKGROUND	Dietary nitrate , which is in green leafy vegetables and beetroot , decreases blood pressure through the enterosalivary nitrate-nitrite-nitric oxide pathway in healthy individuals .
-BACKGROUND	Whether similar effects would occur in individuals with treated hypertension and , therefore , at increased risk of cardiovascular disease is unclear .
-OBJECTIVE	We assessed whether increased dietary nitrate intake by using beetroot juice for 1 wk lowers blood pressure in treated hypertensive men and women .
-METHODS	Participants ( n = 27 ) were recruited to a randomized , placebo-controlled , double-blind crossover trial .
-METHODS	The effect of 1-wk intake of nitrate-rich beetroot juice was compared with 1-wk intake of nitrate-depleted beetroot juice ( placebo ) .
-METHODS	The primary outcome was blood pressure assessed by measuring home blood pressure during the intervention and 24-h ambulatory blood pressure on day 7 of the intervention .
-METHODS	Other outcomes included nitrate metabolism assessed by measuring nitrate and nitrite in plasma , saliva , and urine .
-RESULTS	Relative to the placebo , 1-wk intake of nitrate-rich beetroot juice resulted in a 3-fold increase in plasma nitrite and nitrate , a 7-fold increase in salivary nitrite , an 8-fold higher salivary nitrate , and a 4-fold increase in both urinary nitrite and nitrate ( P < 0.001 ) .
-RESULTS	However , no differences in home blood pressure and 24-h ambulatory blood pressure were observed with 1-wk intake of nitrate-rich beetroot juice in comparison with the placebo .
-CONCLUSIONS	An increase in dietary nitrate intake may not be an effective short-term approach to further lower blood pressure in treated hypertensive subjects .
-
-###25323335
-BACKGROUND	The Oxymizer is a special nasal cannula that provides a higher luminal diameter in combination with an incorporated oxygen ( O2 ) reservoir .
-BACKGROUND	It is assumed that a higher O2 concentration can be delivered breath by breath in order to increase oxygenation .
-OBJECTIVE	We aimed to investigate the effects of the Oxymizer on endurance time in comparison to a conventional nasal cannula ( CNC ) .
-METHODS	Forty-three patients with severe chronic obstructive pulmonary disease ( COPD , age 60 9 years , FEV1 37 16 % pred . )
-METHODS	and indications for LTOT were recruited during pulmonary rehabilitation for this cross-over study .
-METHODS	After an initial maximal incremental cycle test , all patients performed 4 cycling endurance time tests at 70 % of their peak work rate ( twice with the Oxymizer and twice with a CNC , in reverse order ) .
-RESULTS	The endurance time was significantly higher when patients cycled while using the Oxymizer in comparison to while using the CNC [ 858 754 vs. 766 652 s ; between-group difference 92 s ( 95 % confidence interval 32-152 ) , p < 0.001 ] .
-RESULTS	In addition to a longer cycling duration , O2 saturation at isotime was significantly higher with the Oxymizer ( 93.5 5.4 vs. 90.4 5.3 % ; p = 0.027 ) .
-RESULTS	Furthermore , there was a positive correlation ( r = 0.427 , p = 0.002 ) between the O2 flow rate and improvements in the constant work rate test , showing greater improvements in favor of the Oxymizer in patients with a higher demand for O2 ( 4 liters/min ) .
-CONCLUSIONS	We show that O2 delivery via the Oxymizer is superior to a CNC with regard to endurance capacity and oxygenation during exercise in patients with severe COPD .
-CONCLUSIONS	It seems that patients with a higher demand for O2 ( 4 liters/min ) , in particular , may benefit more from the use of the Oxymizer .
-
-###25099201
-BACKGROUND	While acute-phase antipsychotic response has been attributed to 65 % -80 % dopamine D receptor blockade , the degree of occupancy for relapse prevention in the maintenance treatment of schizophrenia remains unknown .
-METHODS	In this secondary study of an open-label , 28-week , randomized , controlled trial conducted between April 2009 and August 2011 , clinically stable patients with schizophrenia ( DSM-IV ) treated with risperidone or olanzapine were randomly assigned to the reduction group ( dose reduced by 50 % ) or maintenance group ( dose kept constant ) .
-METHODS	Plasma antipsychotic concentrations at peak and trough before and after dose reduction were estimated with population pharmacokinetic techniques , using 2 collected plasma samples .
-METHODS	Corresponding dopamine D occupancy levels were then estimated using the model we developed .
-METHODS	Relapse was defined as worsening in 4 Positive and Negative Syndrome Scale-Positive subscale items : delusion , conceptual disorganization , hallucinatory behavior , and suspiciousness .
-RESULTS	Plasma antipsychotic concentrations were available for 16 and 15 patients in the reduction and maintenance groups , respectively .
-RESULTS	Estimated dopamine D occupancy ( mean SD ) decreased following dose reduction from 75.6 % 4.9 % to 66.8 % 6.4 % at peak and 72.3 % 5.7 % to 62.0 % 6.8 % at trough .
-RESULTS	In the reduction group , 10 patients ( 62.5 % ) did not demonstrate continuous D receptor blockade above 65 % ( ie , < 65 % at trough ) after dose reduction ; furthermore , 7 patients ( 43.8 % ) did not achieve a threshold of 65 % occupancy even at peak .
-RESULTS	Nonetheless , only 1 patient met our relapse criteria after dose reduction during the 6 months of the study .
-CONCLUSIONS	The results suggest that the therapeutic threshold regarding dopamine D occupancy may be lower for those who are stable in antipsychotic maintenance versus acute-phase treatment .
-CONCLUSIONS	Positron emission tomography studies are warranted to further test our preliminary findings .
-BACKGROUND	UMIN Clinical Trials Registry identifier : UMIN000001834 .
-
-###25064723
-OBJECTIVE	To determine the prevalence of , risk factors for , and visual acuity ( VA ) correlations with outer retinal tubulation ( ORT ) seen on spectral-domain optical coherence tomography ( SD OCT ) in eyes with neovascular age-related macular degeneration ( AMD ) after anti-vascular endothelial growth factor ( VEGF ) therapy .
-METHODS	Prospective cohort study within a randomized clinical trial .
-METHODS	Patients with SD OCT images at weeks 56 and 104 in the Comparison of AMD Treatments Trials ( CATT ) .
-METHODS	Participants in the CATT were assigned randomly to ranibizumab ( 0.5 mg ) or bevacizumab ( 1.25 mg ) treatment and to a monthly or pro re nata ( PRN ) injection-dosing regimen .
-METHODS	A subset of eyes was imaged with SD OCT beginning at week 56 .
-METHODS	Cirrus 512128 or Spectralis 2020 volume cube scan protocols were used to acquire SD OCT images .
-METHODS	Two independent readers at the CATT OCT reading center graded scans , and a senior reader arbitrated discrepant grades .
-METHODS	The prevalence of ORT , identified as tubular structures seen on at least 3 consecutive Cirrus B scans or 2 consecutive Spectralis B scans , was determined .
-METHODS	The associations of patient-specific and ocular features at baseline and follow-up with ORT were evaluated by univariate and multivariate analyses .
-METHODS	Outer retinal tubulations .
-RESULTS	Seven of 69 eyes ( 10.1 % ) at 56 weeks and 64 of 368 eyes ( 17.4 % ) at week 104 had ORTs .
-RESULTS	Absence of diabetes , poor VA , blocked fluorescence , geographic atrophy , greater lesion size , and presence of subretinal hyperreflective material at baseline were associated independently with greater risk of ORT at 104 weeks ( P < 0.05 ) .
-RESULTS	Neither drug nor dosing regimen were associated significantly with ORT .
-RESULTS	The mean VA of eyes with ORT at week 104 ( 58.5 Early Treatment Diabetic Retinopathy Study letters ) was worse than the mean VA of eyes without ORT ( 68.8 letters ; P < 0.0001 ) .
-CONCLUSIONS	At 2 years after initiation of anti-VEGF therapy for neovascular AMD , ORTs are present in a substantial proportion of eyes .
-CONCLUSIONS	We identified baseline features that independently predict ORTs .
-CONCLUSIONS	It is important to identify ORTs because eyes with ORTs have worse VA outcomes than those without this finding .
-
-###25175385
-OBJECTIVE	Patients with type 2 diabetes are generally treated in primary care setting and as a final treatment step to obtain good glycaemic control , multiple daily insulin injections ( MDI ) are generally used .
-OBJECTIVE	The aim of this study is to evaluate the effect of GLP-1 analogue liraglutide on glycaemic control in patients with type 2 diabetes treated with MDI with inadequate glycaemic control .
-METHODS	Overweight and obese patients with type 2 diabetes and impaired glycaemic control treated with MDI were randomised to liraglutide or placebo over 24 weeks .
-METHODS	Masked continuous glucose monitoring was performed at baseline and during the trial .
-METHODS	The primary endpoint was the change in haemoglobin A1c from baseline to week 24 .
-METHODS	Additional endpoints include changes in weight , fasting glucose , glycaemic variability , treatment satisfaction , insulin dose , hypoglycaemias , blood pressure and blood lipid levels .
-RESULTS	Recruitment occurred between February 2013 and February 2014 .
-RESULTS	A total of 124 patients were randomised .
-RESULTS	Study completion is anticipated in August 2014 .
-CONCLUSIONS	It is expected that the results of this study will establish whether adding liraglutide to patients with type 2 diabetes treated with MDI will improve glycaemic control , lower body weight , and influence glycaemic variability .
-
-###25103176
-BACKGROUND	Standard first-line antiretroviral therapy for HIV-1 infection includes two nucleoside or nucleotide reverse transcriptase inhibitors ( NtRTIs ) , but these drugs have limitations .
-BACKGROUND	We assessed the 96 week efficacy and safety of an NtRTI-sparing regimen .
-METHODS	Between August , 2010 , and September , 2011 , we enrolled treatment-naive adults into this randomised , open-label , non-inferiority trial in treatment-naive adults in 15 European countries .
-METHODS	The composite primary outcome was change to randomised treatment before week 32 because of insufficient virological response , no virological response by week 32 , HIV-1 RNA concentration 50 copies per mL or higher at any time after week 32 ; death from any cause ; any new or recurrent AIDS event ; or any serious non-AIDS event .
-METHODS	Patients were randomised in a 1:1 ratio to receive oral treatment with 400 mg raltegravir twice daily plus 800 mg darunavir and 100 mg ritonavir once daily ( NtRTI-sparing regimen ) or tenofovir-emtricitabine in a 245 mg and 200 mg fixed-dose combination once daily , plus 800 mg darunavir and 100 mg ritonavir once daily ( standard regimen ) .
-METHODS	This trial was registered with ClinicalTrials.gov , number NCT01066962 .
-RESULTS	Of 805 patients enrolled , 401 received the NtRTI-sparing regimen and 404 the standard regimen , with median follow-up of 123 weeks ( IQR 112-133 ) .
-RESULTS	Treatment failure was seen in 77 ( 19 % ) in the NtRTI-sparing group and 61 ( 15 % ) in the standard group .
-RESULTS	Kaplan-Meier estimated proportions of treatment failure by week 96 were 178 % and 138 % , respectively ( difference 40 % , 95 % CI -08 to 88 ) .
-RESULTS	The frequency of serious or treatment-modifying adverse events were similar ( 102 vs 83 per 100 person-years and 39 vs 42 per 100 person-years , respectively ) .
-CONCLUSIONS	Our NtRTI-sparing regimen was non-inferior to standard treatment and represents a treatment option for patients with CD4 cell counts higher than 200 cells per L.
-BACKGROUND	European Union Sixth Framework Programme , Inserm-ANRS , Gilead Sciences , Janssen Pharmaceuticals , Merck Laboratories .
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-###24895449
-BACKGROUND	Higher-risk patients may not receive evidence-based therapy because of limited life expectancy , which is a composite measure that encompasses many patient factors , including age , frailty , and comorbidities .
-BACKGROUND	In this study , we evaluated the extent to which treatment care gaps can be explained by a difference in projected life expectancy .
-RESULTS	An observational cohort study was conducted on acute myocardial infarction patients hospitalized in Ontario , Canada .
-RESULTS	Projected life expectancy was estimated using actual survival data with extrapolation using proportional hazard models adjusting for important covariates .
-RESULTS	The relationship between projected life expectancy with statins and reperfusion therapy was examined using generalized linear models .
-RESULTS	Among the 7001 acute myocardial infarction patients , 84.3 % were prescribed statins and 72.9 % were treated with reperfusion therapy .
-RESULTS	When projected life expectancy was < 10 years , the likelihood of receiving either treatment declined progressively with reduction in life expectancy ( P < 0.001 ) .
-RESULTS	At the 25th percentile of projected life expectancies , the likelihood of receiving a statin decreased by 1.4 % ( 95 % confidence interval , 1.0-1 .8 % ) , and acute reperfusion therapy decreased by 2.6 % ( 95 % confidence interval , 1.8-3 .3 % ) for each year decline in projected life expectancy .
-CONCLUSIONS	Life expectancy of a patient strongly influences evidence-based treatment in acute myocardial infarction .
-CONCLUSIONS	It was seen not only among patients with limited life expectancies but also among those with many years to live .
-CONCLUSIONS	Treatment care gaps may reflect clinicians ' synthesis about frailty and life-expectancy gains .
-
-###25500486
-OBJECTIVE	To compare the bioavailability and safety profile of crushed ticagrelor tablets suspended in water and administered orally or via nasogastric tube , with that of whole tablets administered orally .
-METHODS	In this single-center , open-label , randomized , three-treatment crossover study , 36 healthy volunteers were randomized to receive a single 90-mg dose of ticagrelor administered orally as a whole tablet or as crushed tablets suspended in water and given orally or via a nasogastric tube into the stomach , with a minimum 7-day wash-out between treatments .
-METHODS	Plasma concentrations of ticagrelor and AR-C124910XX were assessed at 0 , 0.5 , 1 , 2 , 3 , 4 , 6 , 8 , 10 , 12 , 16 , 24 , 36 , and 48 hours post-ticagrelor dose for pharmacokinetic analyses .
-METHODS	Safety and tolerability was assessed throughout the study .
-RESULTS	At 0.5 hours postdose , plasma concentrations of ticagrelor and AR-C124910XX were higher with crushed tablets administered orally ( 148.6 ng/mL and 13.0 ng/mL , respectively ) or via nasogastric tube ( 264.6 ng/mL and 28.6 ng/mL , respectively ) compared with whole-tablet administration ( 33.3 ng/mL and 5.2 ng/mL , respectively ) .
-RESULTS	A similar trend was observed at 1 hour postdose .
-RESULTS	Ticagrelor tmax was shorter following crushed vs. whole-tablet administration ( 1 vs. 2 hours , respectively ) .
-RESULTS	Geometric mean ratios between treatments for AUC and Cmax were contained within the bioequivalence limits of 80-125 % for ticagrelor and AR-C124910XX .
-RESULTS	All treatments were generally well tolerated .
-CONCLUSIONS	Ticagrelor administered as a crushed tablet is bioequivalent to whole-tablet administration , independent of mode of administration ( oral or via nasogastric tube ) , and resulted in increased plasma concentrations of ticagrelor and ARC124910XX at early timepoints .
-
-###25223240
-BACKGROUND	Preterm birth leads to an estimated 35 % of neonatal deaths worldwide .
-BACKGROUND	Our study analyses neonatal mortality risks among preterm births in rural Bangladesh .
-METHODS	Trained community health workers ( CHW ) prospectively collected data between June 2007 and September 2009 .
-RESULTS	Among 32126 livebirths , 22.3 % were preterm ( delivered at < 37 weeks gestation ) and almost half ( 46.4 % ) of all neonatal deaths occurred among preterm babies .
-RESULTS	Preterm babies who were born as the first child { [ risk ratio ( RR ) 1.4 ; 95 % confidence interval ( CI ) 1.1 , 1.8 ] } and in the poorest households [ RR 1.7 ; 95 % CI 1.2 , 2.4 ] were at higher mortality risk .
-RESULTS	Birth and newborn care preparedness was associated with lower risk of mortality [ RR 0.3 ; 95 % CI 0.2 , 0.4 ] while preterm infants who had symptoms of infection [ RR 5.6 ; 95 % CI 4.3 , 7.1 ] or whose mother suffered antenatal complications [ RR 1.4 ; 95 % CI 1.1 , 1.8 ] were at higher mortality risk .
-RESULTS	Elimination of excess neonatal deaths caused by preterm would decrease population-level neonatal mortality rate by 31.0 % [ 95 % CI 27.60 % , 34.5 % ] .
-CONCLUSIONS	Given that 87 % of preterm births and 60 % of preterm deaths were in late or moderate preterm infants , and that 87 % preterm babies received a visit from CHW within third day of life , a home-based essential care package delivered by CHWs for sick preterm infants , specifically focused on birth preparedness , skin-to-skin care , immediate breast feeding , early recognition of danger signs , and linked through referral to intensive and quality care in health facilities , could be an effective approach in low resource settings .
-
-###25399551
-BACKGROUND	The BRAF inhibitors vemurafenib and dabrafenib have shown efficacy as monotherapies in patients with previously untreated metastatic melanoma with BRAF V600E or V600K mutations .
-BACKGROUND	Combining dabrafenib and the MEK inhibitor trametinib , as compared with dabrafenib alone , enhanced antitumor activity in this population of patients .
-METHODS	In this open-label , phase 3 trial , we randomly assigned 704 patients with metastatic melanoma with a BRAF V600 mutation to receive either a combination of dabrafenib ( 150 mg twice daily ) and trametinib ( 2 mg once daily ) or vemurafenib ( 960 mg twice daily ) orally as first-line therapy .
-METHODS	The primary end point was overall survival .
-RESULTS	At the preplanned interim overall survival analysis , which was performed after 77 % of the total number of expected events occurred , the overall survival rate at 12 months was 72 % ( 95 % confidence interval [ CI ] , 67 to 77 ) in the combination-therapy group and 65 % ( 95 % CI , 59 to 70 ) in the vemurafenib group ( hazard ratio for death in the combination-therapy group , 0.69 ; 95 % CI , 0.53 to 0.89 ; P = 0.005 ) .
-RESULTS	The prespecified interim stopping boundary was crossed , and the study was stopped for efficacy in July 2014 .
-RESULTS	Median progression-free survival was 11.4 months in the combination-therapy group and 7.3 months in the vemurafenib group ( hazard ratio , 0.56 ; 95 % CI , 0.46 to 0.69 ; P < 0.001 ) .
-RESULTS	The objective response rate was 64 % in the combination-therapy group and 51 % in the vemurafenib group ( P < 0.001 ) .
-RESULTS	Rates of severe adverse events and study-drug discontinuations were similar in the two groups .
-RESULTS	Cutaneous squamous-cell carcinoma and keratoacanthoma occurred in 1 % of patients in the combination-therapy group and 18 % of those in the vemurafenib group .
-CONCLUSIONS	Dabrafenib plus trametinib , as compared with vemurafenib monotherapy , significantly improved overall survival in previously untreated patients with metastatic melanoma with BRAF V600E or V600K mutations , without increased overall toxicity .
-CONCLUSIONS	( Funded by GlaxoSmithKline ; ClinicalTrials.gov number , NCT01597908 . )
-
-###25562205
-OBJECTIVE	This phase 3 trial evaluated the efficacy , safety , and tolerability of low - and high-dose cariprazine in patients meeting DSM-IV-TR criteria for acute manic or mixed episodes associated with bipolar I disorder .
-METHODS	This multicenter , randomized , double-blind , placebo-controlled , parallel-group , fixed/flexible-dose study was conducted from February 2010 to December 2011 .
-METHODS	Patients were randomly assigned to placebo , cariprazine 3-6 mg/d , or cariprazine 6-12 mg/d for 3 weeks of double-blind treatment .
-METHODS	Primary and secondary efficacy parameters were change from baseline to week 3 in Young Mania Rating Scale ( YMRS ) total score and Clinical Global Impressions-Severity of Illness ( CGI-S ) score , respectively .
-METHODS	Post hoc analysis examined change from baseline to week 3 in YMRS single items .
-RESULTS	A total of 497 patients were randomized ; 74 % completed the study .
-RESULTS	The least squares mean difference ( LSMD ) for change from baseline to week 3 in YMRS total score was statistically significant in favor of both cariprazine groups versus placebo ( LSMD [ 95 % CI ] : 3-6 mg/d , -6.1 [ -8.4 to -3.8 ] ; 6-12 mg/d , -5.9 [ -8.2 , -3.6 ] ; P < .001 [ both ] ) .
-RESULTS	Both cariprazine treatment groups showed statistically significant superiority to placebo on all 11 YMRS single items ( all comparisons , P < .05 ) .
-RESULTS	Change from baseline in CGI-S scores was statistically significantly greater in both cariprazine groups compared with placebo ( LSMD [ 95 % CI ] : 3-6 mg/d , -0.6 [ -0.9 to -0.4 ] ; 6-12 mg/d , -0.6 [ -0.9 to -0.3 ] ; P < .001 [ both ] ) .
-RESULTS	The most common ( 5 % and twice the rate of placebo ) treatment-related adverse events for cariprazine were akathisia ( both groups ) and nausea , constipation , and tremor ( 6-12 mg/d only ) .
-CONCLUSIONS	Results of this study demonstrated that both low - and high-dose cariprazine were more effective than placebo in the treatment of acute manic or mixed episodes associated with bipolar I disorder .
-CONCLUSIONS	Cariprazine was generally well tolerated , although the incidence of akathisia was greater with cariprazine than with placebo .
-BACKGROUND	ClinicalTrials.gov identifier : NCT01058668 .
-
-###24762066
-BACKGROUND	Although neoadjuvant chemotherapy ( NAC ) for locally advanced breast cancer can improve operability and local disease control , there is a lack of reliable biomarkers that predict response to chemotherapy or long-term survival .
-BACKGROUND	Since expression of aldehyde dehydrogenase-1 ( ALDH1 ) is associated with the stem-like properties of self-renewal and innate chemoresistance in breast cancer , we asked whether expression in serial tumor samples treated with NAC could identify women more likely to benefit from this therapy .
-METHODS	Women with locally advanced breast cancer were randomly assigned to receive four cycles of anthracycline-based chemotherapy , followed by four cycles of taxane therapy ( Arm A ) , or the same regimen in reverse order ( Arm B ) .
-METHODS	Tumor specimens were collected at baseline , after four cycles , and then at surgical resection .
-METHODS	ALDH1 expression was determined by immunohistochemistry and correlated with tumor response using Fisher 's exact test while Kaplan-Meier method was used to calculate survival .
-RESULTS	A hundred and nineteen women were enrolled into the study .
-RESULTS	Fifty seven ( 48 % ) were randomized to Arm A and 62 ( 52 % ) to Arm B. Most of the women ( 90 % ) had ductal carcinoma and 10 % had lobular carcinoma .
-RESULTS	Of these , 26 ( 22 % ) achieved a pathological complete response ( pCR ) after NAC .
-RESULTS	There was no correlation between baseline ALDH1 expression and tumor grade , stage , hormone receptor , human epidermal growth factor receptor 2 ( HER2 ) status and Ki67 index .
-RESULTS	ALDH1 negativity at baseline was significantly associated with pCR ( P = 0.004 ) .
-RESULTS	The presence of ALDH1 ( + ) cells in the residual tumor cells in non-responding women was strongly predictive of worse overall survival ( P = 0.024 ) .
-RESULTS	Moreover , serial analysis of specimens from non-responders showed a marked increase in tumor-specific ALDH1 expression ( P = 0.028 ) .
-RESULTS	Overall , there was no survival difference according to the chemotherapy sequence .
-RESULTS	However , poorly responding tumours from women receiving docetaxel chemotherapy showed an unexpected significant increase in ALDH1 expression .
-CONCLUSIONS	ALDH1 expression is a useful predictor of chemoresistance .
-CONCLUSIONS	The up-regulation of ALDH1 after NAC predicts poor survival in locally advanced breast cancer .
-CONCLUSIONS	Although the chemotherapy sequence had no effect on overall prognosis , our results suggest that anthracycline-based chemotherapy may be more effective at targeting ALDH1 ( + ) breast cancer cells .
-BACKGROUND	ACTRN12605000588695 .
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-###24893684
-OBJECTIVE	There have been several studies of atrial fibrillation ( AF ) over the past decades ; however , data from Chinese patients are scarce .
-OBJECTIVE	The aim of the study was therefore to describe the patient characteristics , risk profile and management strategies for Chinese AF patients presenting to emergency department ( ED ) .
-METHODS	We conducted a prospective , multicentre registry of patients with AF or atrial flutter ( AFL ) in China .
-METHODS	Participants were enrolled at 20 EDs , then data regarding baseline characteristics and treatment in EDs were collected .
-RESULTS	Of the 2016 Chinese patients , 1104 ( 54.8 % ) were female .
-RESULTS	Six hundred eighteen ( 30.7 % ) had paroxysmal AF , 452 ( 22.4 % ) had persistent AF and 945 ( 46.9 % ) had permanent AF .
-RESULTS	The most common comorbidity was hypertension ( 55.5 % ) , followed by coronary artery disease ( 41.8 % ) and heart failure ( HF , 37.4 % ) .
-RESULTS	The prevalence of concomitant cardiovascular risk factors , such as HF and valvular heart disease , increased as AF progressed .
-RESULTS	Among the patients with non-valvular AF , 110 ( 12.7 % ) of those with CHADS2 ( congestive HF , hypertension , age of 75 years and greater , diabetes mellitus and history of stroke ) 2 were prescribed oral anticoagulants ( OAC ) , while 119 ( 15.6 % ) of those with CHADS2 < 2 received such agents .
-RESULTS	Among the 324 patients with valvular AF , 134 ( 41.4 % ) actually were treated with OAC .
-RESULTS	The international normalised ratio value was within the target range ( 2.0-3 .0 ) in 96 patients only ( 26.4 % ) .
-RESULTS	Moreover , a total of 16.2 % of the patients received 1 anti-arrhythmic agents , whereas rate control agents were used more frequently ( 68.4 % ) .
-CONCLUSIONS	According to the present study , the risk profile and management of Chinese patients with AF/AFL differed from that observed in previous studies .
-CONCLUSIONS	The use of OAC inadequately deviate from current guidelines .
-
-###24638003
-OBJECTIVE	The ACOSOG ( American College of Surgeons Oncology Group ) Z9001 ( Alliance ) study , a randomized , placebo-controlled trial , demonstrated that 1 year of adjuvant imatinib prolonged recurrence-free survival ( RFS ) after resection of primary GI stromal tumor ( GIST ) .
-OBJECTIVE	We sought to determine the pathologic and molecular factors associated with patient outcome .
-METHODS	There were 328 patients assigned to the placebo arm and 317 to the imatinib arm .
-METHODS	Median patient follow-up was 74 months .
-METHODS	There were 645 tumor specimens available for mitotic rate or mutation analysis .
-RESULTS	RFS remained superior in the imatinib arm ( hazard ratio , 0.6 ; 95 % CI , 0.43 to 0.75 ; Cox model-adjusted P < .001 ) .
-RESULTS	On multivariable analysis of patients in the placebo arm , large tumor size , small bowel location , and high mitotic rate were associated with lower RFS , whereas tumor genotype was not significantly associated with RFS .
-RESULTS	Multivariable analysis of patients in the imatinib arm yielded similar findings .
-RESULTS	When comparing the two arms , imatinib therapy was associated with higher RFS in patients with a KIT exon 11 deletion of any type , but not a KIT exon 11 insertion or point mutation , KIT exon 9 mutation , PDGFRA mutation , or wild-type tumor , although some of these patient groups were small .
-RESULTS	Adjuvant imatinib did not seem to alter overall survival .
-CONCLUSIONS	Our findings show that tumor size , location , and mitotic rate , but not tumor genotype , are associated with the natural history of GIST .
-CONCLUSIONS	Patients with KIT exon 11 deletions assigned to 1 year of adjuvant imatinib had a longer RFS .
-
-###24669602
-BACKGROUND	Nausea and vomiting are two of the most frequently experienced postoperative side effects complicating one third of the cases .
-BACKGROUND	The objective of this study was to determine the effectiveness of gastric decompression in reducing the incidence and complications associated with post-tonsillectomy vomiting in children .
-METHODS	This was a randomised control study conducted at the ENT Department , Ayub Teaching Hospital Abbottabad from January to June 2012 .
-METHODS	Patients included in this study were divided into two groups , group A undergoing gastric aspiration and group B not undergoing gastric aspiration .
-METHODS	Gastric aspiration was done with an oro-gastric tube placed under direct visualisation while the patient was still under general anaesthesia .
-METHODS	The incidence of vomiting , episodes of vomiting and the need for rescue anti-emetic prophylaxis were noted .
-RESULTS	A total of 54 patients were included in the study .
-RESULTS	Their ages ranged from 5 to 12 years with mean age 7.85 + / - 2.18 years .
-RESULTS	No statistically significant difference ( p > 0.05 ) was noted between the two groups for the patients experiencing vomiting ( 33 % vs 41 % , p = 0.389 ) , the mean number of episodes of vomiting ( 0.71 vs 0.88 , p = 0.555 ) , and patients requiring rescue anti-emetics ( 11 % vs 15 % , p = 0.500 ) .
-CONCLUSIONS	Gastric aspiration during tonsillectomy is not useful in reducing post-tonsillectomy vomiting .
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-###25239835
-OBJECTIVE	This study evaluated the efficacy and safety of ATL1102 , an antisense oligonucleotide that selectively targets the RNA for human CD49d , the subunit of very late antigen 4 , in patients with relapsing-remitting multiple sclerosis ( RRMS ) .
-METHODS	In a multicenter , double-blind , placebo-controlled randomized phase II trial , 77 patients with RRMS were treated with 200 mg of ATL1102 subcutaneously injected 3 times in the first week and twice weekly for 7 weeks or placebo and monitored for a further 8 weeks .
-METHODS	MRI scans were taken at baseline and weeks 4 , 8 , 12 , and 16 .
-METHODS	The primary endpoint was the cumulative number of new active lesions ( either new gadolinium-enhancing T1 lesions or nonenhancing new or enlarging T2 lesions ) at weeks 4 , 8 , and 12 .
-RESULTS	A total of 72 patients completed the study and 74 intention-to-treat patients were assessed .
-RESULTS	ATL1102 significantly reduced the cumulative number of new active lesions by 54.4 % compared to placebo ( mean 3.0 [ SD 6.12 ] vs 6.2 [ 9.89 ] , p = 0.01 ) .
-RESULTS	The cumulative number of new gadolinium-enhancing T1 lesions was reduced by 67.9 % compared to placebo ( p = 0.002 ) .
-RESULTS	Treatment-emergent adverse events included mild to moderate injection site erythema and decrease in platelet counts that returned to within the normal range after dosing .
-CONCLUSIONS	In patients with RRMS , ATL1102 significantly reduced disease activity after 8 weeks of treatment and was generally well-tolerated .
-CONCLUSIONS	This trial provides evidence for the first time that antisense oligonucleotides may be used as a therapeutic approach in neuroimmunologic disorders .
-METHODS	This study provides Class I evidence that for patients with RRMS , the antisense oligonucleotide ATL1102 reduces the number of new active head MRI lesions .
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-###24485082
-OBJECTIVE	To compare bipolar with standard monopolar transurethral resection of the prostate ( TURP ) .
-METHODS	A prospectively randomized study was conducted between January 2010 and September 2011 .
-METHODS	Primary end points studied were efficacy ( maximum flow rate [ Qmax ] , International Prostate Symptom Score ) and safety ( adverse events , decline in postoperative serum sodium [ Na + ] and haemoglobin [ Hb ] levels ) .
-METHODS	Secondary end points were operation time and duration of irrigation , catheterization , and hospitalization .
-RESULTS	Sixty consecutive patients were randomized and completed the study , with 29 patients in the monopolar TURP group and 31 in the TURIS group .
-RESULTS	At baseline , the two groups were comparable in age , prostate volume , mean prostate-specific antigen value , International Prostate Symptom Score , and they had at least 12 months of follow-up .
-RESULTS	Declines in the mean postoperative serum Na + for bipolar and monopolar TURP groups were 1.2 and 8.7 mmol/L , respectively .
-RESULTS	However , there was no statistical difference in the decline in postoperative Hb between the two groups .
-RESULTS	The mean catheterization time was 26.6 and 52 hours in the bipolar and standard groups , respectively .
-RESULTS	This difference was statistically significant as was the difference in the time to hospital discharge .
-RESULTS	The IPSS and Qmax improvements were comparable between the two groups at 12 months of follow-up .
-CONCLUSIONS	No clinically relevant differences in short-term efficacy are existed between the two techniques , but bipolar TURP is preferable due to a more favorable safety profile and shorter catheterization duration .
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-###24337434
-OBJECTIVE	Larger biopsy specimens or increasing the number of biopsies may improve the diagnostic accuracy of gastric epithelial neoplasia ( GEN ) .
-OBJECTIVE	The aims of this study was to compare the diagnostic accuracies between conventional and jumbo forceps biopsy of GEN before endoscopic submucosal dissection ( ESD ) and to confirm that increasing the number of biopsies is useful for the diagnosis of GEN.
-RESULTS	The concordance rate between EFB and ESD specimens was not significantly different between the two groups [ 83.1 % ( 54/65 ) in JG vs. 79.1 % ( 53/67 ) in CG ] .
-RESULTS	On multivariate analyses , two or four EFBs significantly increased the cumulating concordance rate [ coefficients ; twice : 5.1 ( P = 0.01 ) , four times : 5.9 ( P = 0.02 ) ] .
-RESULTS	But , the concordance rate was decreased in high grade dysplasia ( coefficient -40.32 , P = 0.006 ) .
-METHODS	One hundred and sixty GENs from 148 patients were randomized into two groups and finally 67 GENs in 61 patients and 65 GENs in 63 patients were allocated to the conventional group ( CG ) or jumbo group ( JG ) , respectively .
-METHODS	Four endoscopic forceps biopsy ( EFB ) specimens were obtained from each lesion with conventional ( 6.8 mm ) forceps or jumbo ( 8 mm ) forceps .
-METHODS	The histological concordance rate between 4 EFB specimens and ESD specimens was investigated in the two groups .
-CONCLUSIONS	Before ESD , the diagnostic accuracy of GENs was significantly increased not by the use of jumbo forceps biopsy but by increasing the number of biopsies .
-
-###25378648
-OBJECTIVE	Prospective trials specifically designed for elderly patients with advanced non-small-cell lung cancer demonstrating the benefit of platinum-based therapies are still lacking .
-OBJECTIVE	This trial was designed to clarify whether the addition of cisplatin to monotherapy could improve survival for elderly patients .
-METHODS	Elderly patients ( age 70 years , ECOG performance Status 0-1 ) with advanced non-small-cell lung cancer were randomized to receive docetaxel 20 mg/m ( 2 ) plus cisplatin 25 mg/m ( 2 ) on Day 1 , 8 and 15 ( docetaxel plus cisplatin ) or docetaxel 25 mg/m ( 2 ) on the same schedule ( docetaxel ) .
-METHODS	Both regimens were repeated every 4 weeks until disease progression .
-RESULTS	One hundred and twenty-six patients were enrolled .
-RESULTS	Sixty-three were randomly assigned docetaxel plus cisplatin and 63 docetaxel monotherapy .
-RESULTS	Median age was 76 years ( range 70-88 ) .
-RESULTS	The second planned interim analysis was performed on 112 assessable patients ( docetaxel/docetaxel plus cisplatin : 56/56 ) .
-RESULTS	Although the formal criterion for stopping the trial was not met , the Data and Safety Monitoring Committee recommended study termination on ethical grounds based on the interaction ( two-sided P = 0.077 , hazard ratios for 74/75 : 0.23 / 0.72 ) between age and subgroup and treatment arm , which suggested that docetaxel may not represent an adequate control arm regimen for the age subgroup of 70-74 years .
-CONCLUSIONS	The interpretation of study results is limited due to early stopping .
-CONCLUSIONS	Further study is needed to confirm survival benefit of platinum-based chemotherapy for elderly non-small-cell lung cancer [ UMIN-CTR ( www.umin.ac.jp/ctr/ ) ID : C000000146 ] .
-
-###24885384
-BACKGROUND	Recommended therapy duration for patients hospitalized with cellulitis is 10-14 days .
-BACKGROUND	Unnecessary use of antibiotics is one of the key factors driving resistance .
-BACKGROUND	Recent studies have shown that antibiotic therapy for cellulitis in outpatients can safely be shortened , despite residual inflammation .
-BACKGROUND	This study will compare in hospitalized patients the safety and effectiveness of shortening antibiotic therapy for cellulitis from 12 to 6 days .
-METHODS	In a multicenter , randomized , double-blind , non-inferiority trial , adult patients admitted with cellulitis will be included .
-METHODS	Cellulitis is defined as warmth , erythema , and induration of the skin and/or subcutaneous tissue , with or without pain ( including erysipelas ) .
-METHODS	All patients will initially be treated with intravenous flucloxacillin , and will be evaluated after 5-6 days .
-METHODS	Those who have improved substantially ( defined as being afebrile , and having a lower cellulitis severity score ) will be randomized at day 6 between additional 6 days of oral flucloxacillin ( n = 198 ) or placebo ( n = 198 ) .
-METHODS	Treatment success is defined as resolution of cellulitis on day 14 ( disappearance of warmth and tenderness , improvement of erythema and edema ) , without the need of additional antibiotics for cellulitis by day 28 .
-METHODS	Secondary endpoints are relapse rate ( up to day 90 ) , speed of recovery ( using a cellulitis severity score until day 28 , and VAS scores on pain and swelling until day 90 ) , quality of life ( using the SF-36 and EQ-5D questionnaires ) and costs ( associated with total antibiotic use and health-care resource utilization up to day 90 ) .
-CONCLUSIONS	Inclusion is planned to start in Q2 2014 .
-BACKGROUND	ClinicalTrials.gov ( NCT02032654 ) and the Netherlands Trial Register ( NTR4360 ) .
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-###25564105
-BACKGROUND	Injection opioid use plays a significant role in the transmission of HIV infection in many communities and several regions of the world .
-BACKGROUND	Access to evidence-based treatments for opioid use disorders is extremely limited .
-METHODS	HIV Prevention Trials Network 058 ( HPTN 058 ) was a randomized controlled trial designed to compare the impact of 2 medication-assisted treatment ( MAT ) strategies on HIV incidence or death among opioid-dependent people who inject drugs ( PWID ) .
-METHODS	HIV-negative opioid-dependent PWID were recruited from 4 communities in Thailand and China with historically high prevalence of HIV among PWID .
-METHODS	A total of 1251 participants were randomly assigned to either ( 1 ) a 1-year intervention consisting of 2 opportunities for a 15-day detoxification with buprenorphine/naloxone ( BUP/NX ) combined with up to 21 sessions of behavioral drug and risk counseling [ short-term medication-assisted treatment ( ST-MAT ) ] or ( 2 ) thrice-weekly dosing for 48 weeks with BUP/NX and up to 21 counseling sessions [ long-term medication-assisted treatment ( LT-MAT ) ] followed by dose tapering .
-METHODS	All participants were followed for 52 weeks after treatment completion to assess durability of impact .
-RESULTS	Although the study was stopped early due to lower than expected occurrence of the primary end points , sufficient data were available to assess the impact of the interventions on drug use and injection-related risk behavior .
-RESULTS	At week 26 , 22 % of ST-MAT participants had negative urinalyses for opioids compared with 57 % in the LT-MAT ( P < 0.001 ) .
-RESULTS	Differences disappeared in the year after treatment : at week 78 , 35 % in ST-MAT and 32 % in the LT-MAT had negative urinalyses .
-RESULTS	Injection-related risk behaviors were significantly reduced in both groups after randomization .
-CONCLUSIONS	Participants receiving BUP/NX 3 times weekly were more likely to reduce opioid injection while on active treatment .
-CONCLUSIONS	Both treatment strategies were considered safe and associated with reductions in injection-related risk behavior .
-CONCLUSIONS	These data support the use of thrice-weekly BUP/NX as a way to reduce exposure to HIV risk .
-CONCLUSIONS	Continued access to BUP/NX may be required to sustain reductions in opioid use .
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-###25398701
-BACKGROUND	Medication use is a potentially modifiable risk factor for falling ; psychotropic and cardiovascular drugs have been indicated as main drug groups that increase fall risk .
-BACKGROUND	However , evidence is mainly based on studies that recorded falls retrospectively and/or did not determine medication use at the time of the fall .
-BACKGROUND	Therefore , we investigated the associations indicated in the literature between medication use and falls , using prospectively recorded falls and medication use determined at the time of the fall .
-METHODS	Data from the B-PROOF ( B-vitamins for the prevention of osteoporotic fractures ) study were used , concerning community-dwelling elderly aged 65 years .
-METHODS	We included 2,407 participants with pharmacy dispensing records .
-METHODS	During the 2 - to 3-year follow-up , participants recorded falls using a fall calendar .
-METHODS	Cox proportional hazard models were applied , adjusting for potential confounders including age , sex , health status variables and concomitant medication use .
-RESULTS	During follow-up , 1,147 participants experienced at least one fall .
-RESULTS	Users of anti-arrhythmic medication had an increased fall risk ( hazard ratio [ HR ] 1.61 ; 95 % confidence interval [ CI ] 1.12-2 .32 ) compared with non-users .
-RESULTS	Similarly , non-selective beta-blocker use was associated with an increased fall risk ( HR 1.41 [ 95 % CI 1.12-1 .78 ] ) , while statin use was associated with a lower risk ( HR 0.81 [ 95 % CI 0.71-0 .94 ] ) .
-RESULTS	Benzodiazepine use ( HR 1.32 [ 95 % CI 1.02-1 .71 ] ) , and antidepressant use ( HR 1.40 [ 95 % CI 1.07-1 .82 ] ) were associated with an increased fall risk .
-RESULTS	Use of other cardiovascular and psychotropic medication was not associated with fall risk .
-CONCLUSIONS	Our results strengthen the evidence for an increased fall risk in community-dwelling elderly during the use of anti-arrhythmics , non-selective beta-blockers , benzodiazepines , and antidepressant medication .
-CONCLUSIONS	Clinicians should prescribe these drugs cautiously and if possible choose safer alternatives for older patients .
-
-###24241095
-BACKGROUND	Patients with end-stage renal disease are at a high risk of adverse cardiovascular events .
-BACKGROUND	Elevated level of homocysteine is an important risk factor for cardiovascular morbidity and mortality in dialysis patients .
-BACKGROUND	There are some strategies for reduction of serum homocysteine level in these patients , including folate and vitamin supplementation .
-BACKGROUND	The aim of the present study was to evaluate the effect of omega-3 supplementation on serum homocysteine level in patients on hemodialysis .
-METHODS	In a randomized controlled trial , 100 hemodialysis patients were assigned into two groups to receive omega-3 ( oral capsule , 3 g/d ) or placebo for 2 months .
-METHODS	Complete blood count , blood urea nitrogen , serum creatinine , serum lipids , and serum homocysteine levels were measured before the study and after 2 months at the end of study .
-RESULTS	Of 100 patients , 6 in each group were excluded , and 44 patients in each group completed the study .
-RESULTS	There were no significant differences regarding the age , sex , and the number of dialysis sessions per week between the two groups .
-RESULTS	No difference was observed between the two groups in the laboratory investigations at the end of the study , except for a significant reduction in serum homocysteine level in the omega-3 group as compared to the placebo group ( P = .03 ) .
-CONCLUSIONS	Our study showed a significant reduction regulated by omega-3 supplementation in serum homocysteine level which is a cardiovascular risk factor among hemodialysis patients .
-CONCLUSIONS	Omega-3 can be considered as another homocysteine-reducing agent in this population .
-
-###26041848
-BACKGROUND	Intra-articular corticosteroids are a mainstay in the treatment of knee osteoarthritis , and in clinical trials , they demonstrate a large initial analgesic effect that wanes over one to four weeks with the rapid efflux of drug from the joint .
-BACKGROUND	The present study was undertaken to determine if FX006 , an extended-release formulation of triamcinolone acetonide , can provide pain relief that is superior to the current standard of care , immediate-release triamcinolone acetonide .
-METHODS	In this Phase-2 , double-blind , multicenter study , 228 patients with moderate to severe knee osteoarthritis pain were randomized to a single intra-articular injection of FX006 ( containing 10 , 40 , or 60 mg of triamcinolone acetonide ) or 40 mg of immediate-release triamcinolone acetonide .
-METHODS	Data on the mean daily pain on the 11-point Numeric Rating Scale were collected over twelve weeks ; the primary efficacy end point was the change from baseline to each of eight , ten , and twelve weeks in the weekly mean of the mean daily pain intensity scores analyzed with a longitudinal mixed-effects model .
-RESULTS	The 10-mg dose of FX006 produced pain relief that was improved relative to immediate-release triamcinolone acetonide at two through twelve weeks , although the difference in pain relief was not significant ( p 0.05 ) .
-RESULTS	The 40-mg dose of FX006 produced pain relief that was improved at two through twelve weeks and was significantly superior to immediate-release triamcinolone acetonide at five to ten weeks ( p < 0.05 at each time point ) .
-RESULTS	At the 40-mg dose of FX006 , prespecified secondary analyses , including responder analyses and all Western Ontario and McMaster Universities subscales , were significantly superior ( p < 0.05 ) to immediate-release triamcinolone acetonide at eight weeks , and the time-weighted mean pain relief ( assessed with mean daily pain intensity scores ) was significantly superior to immediate-release triamcinolone acetonide over one to twelve weeks ( p = 0.04 ) .
-RESULTS	The 60-mg dose did not provide additional improvement relative to the 40-mg dose .
-RESULTS	Adverse events were generally mild and similar across all treatments .
-CONCLUSIONS	Intra-articular injection of FX006 , an extended-release formulation of triamcinolone acetonide , provided a clinically relevant improvement in pain relief in patients with knee osteoarthritis relative to immediate-release triamcinolone acetonide , the current standard of care .
-METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .
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-###25282165
-BACKGROUND	The MitraClip REALISM ( Abbott Vascular , Menlo Park , CA ) trial included several inclusion criteria to identify patients at high risk for conventional mitral valve ( MV ) surgery .
-BACKGROUND	This study evaluated contemporary surgical outcomes for high-risk surgical patients who met these defined criteria to serve as a benchmark to evaluate appropriateness in treatment allocation between surgical and percutaneous MV repair .
-METHODS	A statewide Society for Thoracic Surgeons ( STS ) database was queried for patients undergoing isolated mitral valve surgery over a 12-year study period from 17 different hospitals .
-METHODS	Patients were stratified into high-risk ( HR ) versus non-high-risk ( non-HR ) cohorts based upon clinical criteria similar to those utilized in the REALISM trial .
-METHODS	Mixed effects multivariable regression modeling was used to evaluate study endpoints including mortality , morbidity , and resource utilization .
-RESULTS	Of 2,440 isolated mitral operations , 29 % ( n = 698 ) were HR per REALISM criteria .
-RESULTS	Median STS Predicted Risk of Mortality ( PROM ) for HR patients was 6.6 % compared with 1.6 % for non-HR patients ( p < 0.001 ) .
-RESULTS	The HR patients more commonly underwent MV replacement as well as urgent ( 30 % vs 19 % , p < 0.001 ) operations .
-RESULTS	High-risk patients incurred higher morbidity and mortality ( 7 % vs 1.6 % ) with longer intensive care unit ( 48 vs 41 hours ) and hospital stays ( 7 vs 6 days , all p < 0.001 ) .
-RESULTS	Among REALISM criteria , STS PROM 12 % or greater and high-risk STS criteria were the only criteria associated with mortality .
-CONCLUSIONS	Select REALISM criteria , including reoperation with patent grafts and functional MR with ejection fraction less than 0.40 , may not identify patients truly at high risk of death with surgery .
-CONCLUSIONS	In addition to conventional STS criteria , risk assessment by surgeons is essential to direct appropriate treatment allocation for high-risk mitral disease .
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-###25161816
-OBJECTIVE	Identification of pretreatment patient characteristics predictive of psychotherapy outcome could help to guide treatment choices .
-OBJECTIVE	This study evaluates patients ' initial level of immature defense style as a predictor of the outcome of short-term versus long-term psychotherapy .
-METHODS	In the Helsinki Psychotherapy Study , 326 adult outpatients with mood or anxiety disorder were randomized to individual short-term ( psychodynamic or solution-focused ) or long-term ( psychodynamic ) psychotherapy .
-METHODS	Their defense style was assessed at baseline using the 88-item Defense Style Questionnaire and classified as low or high around the median value of the respective score .
-METHODS	Both specific ( Beck Depression Inventory [ BDI ] , Hamilton Depression Rating Scale [ HDRS ] , Symptom Check List Anxiety Scale [ SCL-90-Anx ] , Hamilton Anxiety Rating Scale [ HARS ] ) and global ( Symptom Check List Global Severity Index [ SCL-90-GSI ] , Global Assessment of Functioning Scale [ GAF ] ) psychiatric symptoms were measured at baseline and 3-7 times during a 3-year follow-up .
-RESULTS	Patients with high use of immature defense style experienced greater symptom reduction in long-term than in short-term psychotherapy by the end of the 3-year follow-up ( 50 % vs. 34 % ) .
-RESULTS	Patients with low use of immature defense style experienced faster symptom reduction in short-term than in long-term psychotherapy during the first year of follow-up ( 34 % vs. 19 % ) .
-CONCLUSIONS	Knowledge of patients ' initial level of immature defense style may potentially be utilized in tailoring treatments .
-CONCLUSIONS	Further research on defense styles as outcome predictors in psychotherapies of different types is needed .
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-###25048494
-OBJECTIVE	The purpose of this study was to compare once-daily tacrolimus with twice-daily tacrolimus in terms of safety , efficacy , and patient satisfaction .
-METHODS	This prospective , randomized , open-label , multicenter study was conducted at three institutes .
-METHODS	Patients in the investigational group were converted from tacrolimus twice daily to the same dose of extended-release tacrolimus once daily at 1 month post-transplantation , while patients in the control group were maintained on tacrolimus twice daily .
-METHODS	The efficacies , safeties , and patient satisfaction for the two drugs at 6 months post-transplantation were compared .
-RESULTS	Sixty patients were enrolled and randomized to the investigational group ( 28 of 29 patients completed the study ) or the control group ( 26 of 31 patients completed the study ) .
-RESULTS	At 6 months post-transplantation , composite efficacy failure rates including the incidences of biopsy-confirmed acute rejection in the investigational and control groups were 0 % and 10.7 % , respectively ; patient survival was 100 % in each group .
-RESULTS	No difference in estimated glomerular filtration rate values were observed at 6 months post-transplantation ( p = 0.97 ) .
-RESULTS	The safety and satisfaction profile ( immunosuppressant therapy barrier scale ) of once-daily tacrolimus was comparable with that of twice-daily tacrolimus ( p = 0.35 ) .
-CONCLUSIONS	Conversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation is safe and effective .
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-###25286914
-BACKGROUND	Serelaxin is a promising therapy for acute heart failure .
-BACKGROUND	The renal hemodynamic effects of serelaxin in patients with chronic heart failure are unknown .
-RESULTS	In this double-blind , randomized , placebo-controlled , multicenter study , patients with New York Heart Association Class II to III chronic heart failure , left ventricular ejection fraction 45 % , and estimated glomerular filtration rate ( GFR ) 30 to 89 mL/min per 1.73 m ( 2 ) received intravenous serelaxin 30 g/kg per day or placebo for 24 hours .
-RESULTS	Primarily , we assessed the difference between serelaxin and placebo on renal plasma flow ( para-aminohippuric acid clearance ) and GFR ( iothalamate clearance ) over 8 to 24 hours .
-RESULTS	All 22 patients from 1 clinical site were excluded from primary analyses before unblinding because of implausible measurements .
-RESULTS	The primary analysis comprised 65 patients , mean age was 68 ( 10 ) years , 89 % were male , mean estimated GFR was 64 ( 19 ) mL/min per 1.73 m ( 2 ) , and 34 % had New York Heart Association Class III symptoms .
-RESULTS	Renal plasma flow increased by 29 % with serelaxin and 14 % with placebo ( 13 % relative increase with serelaxin ; P = 0.0386 ) , whereas GFR changes did not differ significantly during 8 to 24 hours .
-RESULTS	Filtration fraction increased by 36 % with serelaxin and 62 % with placebo ( 16 % relative decrease with serelaxin ; P = 0.0019 ) during 8 to 24 hours .
-RESULTS	Changes in systolic blood pressure were largely similar , and creatinine clearance did not differ between groups .
-RESULTS	Adverse event rates were similar with serelaxin ( 20.5 % ) and placebo ( 25.0 % ) .
-CONCLUSIONS	In patients with chronic heart failure , serelaxin increased renal plasma flow and reduced the increase in filtration fraction compared with placebo , but did not affect GFR .
-CONCLUSIONS	These results suggest beneficial renal hemodynamic effects in patients with chronic heart failure .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01546532 .
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-###25455115
-BACKGROUND	Low-income and racial/ethnic minority populations experience disproportionate colorectal cancer ( CRC ) burden and poorer survival .
-BACKGROUND	Novel behavioral strategies are needed to improve screening rates in these groups .
-BACKGROUND	The study aimed to test a theoretically based `` implementation intentions '' intervention for improving CRC screening among unscreened adults in urban safety-net clinics .
-METHODS	Randomized controlled trial .
-METHODS	Adults ( N = 470 ) aged 50 years , due for CRC screening , from urban safety-net clinics were recruited .
-METHODS	The intervention ( conducted in 2009-2011 ) was delivered via touchscreen computers that tailored informational messages to decisional stage and screening barriers .
-METHODS	The computer then randomized participants to generic health information on diet and exercise ( Comparison group ) or `` implementation intentions '' questions and planning ( Experimental group ) specific to the CRC screening test chosen ( fecal immunochemical test or colonoscopy ) .
-METHODS	The primary study outcome was completion of CRC screening at 26 weeks based on test reports ( analysis conducted in 2012-2013 ) .
-RESULTS	The study population had a mean age of 57 years and was 42 % non-Hispanic African American , 28 % non-Hispanic white , and 27 % Hispanic .
-RESULTS	Those receiving the implementation intentions-based intervention had higher odds ( AOR = 1.83 , 95 % CI = 1.23 , 2.73 ) of completing CRC screening than the Comparison group .
-RESULTS	Those with higher self-efficacy for screening ( AOR = 1.57 , 95 % CI = 1.03 , 2.39 ) , history of asthma ( AOR = 2.20 , 95 % CI = 1.26 , 3.84 ) , no history of diabetes ( AOR = 1.86 , 95 % CI = 1.21 , 2.86 ) , and reporting they had never heard that `` cutting on cancer '' makes it spread ( AOR = 1.78 , 95 % CI = 1.16 , 2.72 ) were more likely to complete CRC screening .
-CONCLUSIONS	The results of this study suggest that programs incorporating an implementation intentions approach can contribute to successful completion of CRC screening even among very low-income and diverse primary care populations .
-CONCLUSIONS	Future initiatives to reduce CRC incidence and mortality disparities may be able to employ implementation intentions in large-scale efforts to encourage screening and prevention behaviors .
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-###24818986
-OBJECTIVE	Increased utilization of online medical information seeking demands investigation of potentially detrimental effects of these activities .
-OBJECTIVE	The present study investigated whether viewing medical websites may adversely affect anxiety sensitivity ( AS ) , a well-established risk factor for the development of psychopathology .
-METHODS	Participants ( N = 52 ) were randomly assigned to view medical symptom related websites or general health and wellness control websites .
-METHODS	AS was measured before and after the website viewing .
-RESULTS	Individuals in the medical website group reported higher AS compared to the control group at post-manipulation after controlling for baseline health anxiety and baseline AS .
-RESULTS	Additionally , intolerance of uncertainty ( IU ) , an individual difference variable assessing negative beliefs about uncertainty , significantly moderated this effect such that medical website viewing only affected AS in participants with high IU but not in participants with low IU .
-CONCLUSIONS	The limitations of the current study include the lack of individualization of the website viewing and the short duration of the website viewing .
-CONCLUSIONS	The results of this study provide initial evidence that exposure to online medical information could increase risk for anxiety psychopathology in individuals with elevated IU .
-CONCLUSIONS	Additionally , these results provide support for a learning based model of the etiology of AS .
-
-###24290415
-BACKGROUND	Miglitol is an - glucosidase inhibitor ( AGI ) used as an antihyperglycemic agent in the treatment of type 2 diabetes mellitus .
-BACKGROUND	The mechanism is that miglitol binds to and inhibits the - glucosidase reversibly in the proximal intestine .
-BACKGROUND	Thus , carbohydrates not digested in the upper small intestine are transported to the lower intestine where they are eventually digested .
-OBJECTIVE	This study was performed for the subsequent marketing of the test miglitol formulation in Korea .
-OBJECTIVE	We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy male adult volunteers .
-METHODS	A total of 40 healthy adult subjects were enrolled in this single-dose , randomized , open-label , 2-period , 2-sequence , crossover bioequivalence study .
-METHODS	During each period , subjects received 100 mg of miglitol test or reference .
-METHODS	Blood samples from the subjects were obtained before dosing at 0.5 , 1 , 1.5 , 2 , 3 , 4 , 5 , 6 , 7 , 9 , and 12 hours after oral drug administration .
-METHODS	Plasma concentrations were determined by using liquid chromatography/mass spectrometry/mass spectrometry ( LC-MS/MS ) .
-METHODS	The PK parameters including AUCt , AUC , Cmax , and tmax were measured and all treatment-emergent adverse events ( TEAEs ) and their relationships to study these medications were recorded throughout the entire study .
-RESULTS	A total of 40 healthy adult male Korean subjects were enrolled in the study and randomized into two treatment groups .
-RESULTS	Ultimately , 33 subjects completed the study .
-RESULTS	During each treatment period , blood samples were collected at specific time intervals from 0 to 12 hours after administration of a single drug dose .
-RESULTS	The PK parameters including AUCt , AUC , Cmax , and tmax were calculated and the 90 % CIs of the ratio ( test/reference ) of the parameters were obtained by analysis of variance ( ANOVA ) on logarithmically transformed data .
-RESULTS	The 90 % CIs of the geometric mean ratios for the test to reference formulations were as follows : 1.05 ( 0.97 - 1.13 ) for AUCt and 1.05 ( 0.96 - 1.14 ) for Cmax .
-RESULTS	Statistical analysis confirmed that the 90 % CIs for these PK parameters were within the commonly accepted bioequivalence range of 0.8 - 1.25 .
-RESULTS	There were no serious or unexpected TEAEs during the study .
-CONCLUSIONS	In the healthy adult Korean subjects , the test and reference formulations had similar PK parameters and similar plasma concentration-time profiles .
-CONCLUSIONS	The test formulation of miglitol met the Korean regulatory criteria ( AUCt and Cmax ) for assuming bioequivalence and both formulations were generally well-tolerated .
-CONCLUSIONS	The CRiS identifiers : KCT0000770 .
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-###25184981
-OBJECTIVE	To compare clerkship medical students ' confidence in performing a simulated normal vaginal delivery ( NVD ) after participating in a simulation training session using two different models .
-METHODS	Medical students were randomized to participate in a simulated NVD session using either an obstetrics mannequin or a birthing pelvis model .
-METHODS	Questionnaires were used to assess confidence and evaluate the simulation before and immediately after the session and on the last day of the obstetrics clerkship rotation .
-RESULTS	One hundred ten students were randomized .
-RESULTS	At the start of the clerkship , both groups had similar obstetrics exposure and confidence levels .
-RESULTS	Only 15 students ( 13.9 % ) agreed they were ready to attempt a NVD with minimal supervision or independently .
-RESULTS	This increased significantly to 43 students ( 39.4 % ) immediately after the session .
-RESULTS	At the end of the clerkship , 79 of 81 responding students ( 97.5 % ) were confident that they could attempt a NVD with minimal supervision or independently .
-RESULTS	There were no significant differences noted between simulator groups at any point .
-RESULTS	The sessions were rated as equally useful and realistic , and this remained unchanged at the end of the clerkship .
-CONCLUSIONS	Simulated NVD training using either an obstetrics mannequin or a birthing pelvis model provides clerkship students with a positive experience and increases confidence immediately .
-CONCLUSIONS	It should be implemented early in the rotation , as it appears the clerkship experience also plays a large role in terms of students ' confidence .
-CONCLUSIONS	Despite this , students maintain this type of learning is useful .
-CONCLUSIONS	Effective simulation training can easily be incorporated into clerkship training .
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-###25762226
-OBJECTIVE	Pulmonary rehabilitation ( PR ) provides benefit for patients with chronic obstructive pulmonary disease ( COPD ) in terms of quality of life ( QoL ) and exercise capacity ; however , the effects diminish over time .
-OBJECTIVE	Our aim was to evaluate a maintenance programme for patients who had completed PR .
-METHODS	Primary and secondary care PR programmes in Norfolk .
-METHODS	148 patients with COPD who had completed at least 60 % of a standard PR programme were randomised and data are available for 110 patients .
-METHODS	Patients had greater than 20 pack year smoking history and less than 80 % predicted forced expiratory volume in 1s but no other significant disease or recent respiratory tract infection .
-METHODS	Patients were randomised to receive a maintenance programme or standard care .
-METHODS	The maintenance programme consisted of 2h ( 1h individually tailored exercise training and 1h education programme ) every 3months for 1year .
-METHODS	The Chronic Respiratory Questionnaire ( CRQ ) ( primary outcome ) , endurance shuttle walk test ( ESWT ) , EuroQol ( EQ5D ) , hospital anxiety and depression score ( HADS ) , body mass index ( BMI ) , body fat , activity levels ( overall score and activity diary ) and exacerbations were assessed before and after 12months .
-RESULTS	There was no statistically significant difference between the groups for the change in CRQ dyspnoea score ( primary end point ) at 12months which amounted to 0.19 ( -0.26 to 0.64 ) units or other domains of the CRQ .
-RESULTS	There was no difference in the ESWT duration ( -10.06 ( -191.16 to 171.03 ) seconds ) , BMI , body fat , EQ5D , MET-minutes , activity rating , HADS , exacerbations or admissions .
-CONCLUSIONS	A maintenance programme of three monthly 2h sessions does not improve outcomes in patients with COPD after 12months .
-CONCLUSIONS	We do not recommend that our maintenance programme is adopted .
-CONCLUSIONS	Other methods of sustaining the benefits of PR are required .
-BACKGROUND	NCT00925171 .
-
-###25462393
-BACKGROUND	Only few randomized trials comparing sustained effects of short - and long-term psychotherapies in personality functioning are available .
-BACKGROUND	In this study we compared the effects of two short-term therapies and long-term psychodynamic psychotherapy on patients ' personality functioning during a 5-year follow-up .
-METHODS	Altogether 326 patients of the Helsinki Psychotherapy Study , with anxiety or mood disorder , were randomly assigned to either short-term psychotherapy of about six months ( solution-focused therapy ( SFT , n = 97 ) or short-term psychodynamic psychotherapy ( SPP , n = 101 ) ) , or to long-term psychodynamic psychotherapy ( LPP , n = 128 ) , lasting on average three years .
-METHODS	Outcomes in personality functioning ( i.e. , self-concept , defense style , interpersonal problems , and level of personality organization ) were assessed five to seven times using , respectively , questionnaires ( SASB , DSQ , IIP ) and interview ( LPO ) during the 5-year follow-up from randomization .
-RESULTS	Personality functioning improved in all therapy groups .
-RESULTS	Both short-term therapies fared better than LPP during the first year of follow-up , by faster improvement in self-concept and decrease in immature defense style .
-RESULTS	SFT also showed more early reduction of interpersonal problems .
-RESULTS	However , LPP thereafter showed larger and more sustained benefits than SFT and SPP , through greater changes in self-concept .
-RESULTS	Additionally , LPP outperformed SFT at the end of the follow-up in IIP and LPO , after adjustment for auxiliary treatment .
-RESULTS	No differences were noted between the short-term therapies at any measurement point .
-CONCLUSIONS	Auxiliary treatment was used relatively widely which limits generalization to exclusive use of short - or long-term therapy .
-CONCLUSIONS	LPP seems to be somewhat more effective than short-term therapies in facilitating longterm changes in personality functioning .
-
-###24389518
-OBJECTIVE	Acute oral tyrosine administration has been associated with increased constant-load , submaximal exercise capacity in the heat .
-OBJECTIVE	This study sought to determine whether self-paced exercise performance in the heat is enhanced with the same tyrosine dosage .
-METHODS	After familiarization , seven male endurance-trained volunteers , unacclimated to exercise in the heat , performed two experimental trials in 30C ( 60 % relative humidity ) in a crossover fashion separated by at least 7 d. Subjects ingested 150 mgkg ( -1 ) body mass tyrosine ( TYR ) or an isocaloric quantity of whey powder ( PLA ) in 500 mL of sugar-free flavored water in a randomized , double-blind fashion .
-METHODS	Sixty minutes after drink ingestion , the subjects cycled for 60 min at 57 % 4 % peak oxygen uptake ( VO2peak ) and then performed a simulated cycling time trial requiring completion of an individualized target work quantity ( 393.1 39.8 kJ ) .
-RESULTS	The ratio of plasma tyrosine plus phenylalanine ( tyrosine precursor ) to amino acids competing for brain uptake ( free-tryptophan , leucine , isoleucine , valine , methionine , threonine , and lysine ) increased 2.5-fold from rest in TYR and remained elevated throughout exercise ( P < 0.001 ) , whereas it declined in PLA from rest to preexercise ( P = 0.004 ) .
-RESULTS	Time-trial power output ( P = 0.869 ) and performance ( 34.8 6.5 and 35.2 8.3 min in TYR and PLA , respectively ; P = 0.4167 ) were similar between trials .
-RESULTS	Thermal sensation ( P > 0.05 ) , RPE ( P > 0.05 ) , core temperature ( P = 0.860 ) , skin temperature ( P = 0.822 ) , and heart rate ( P = 0.314 ) did not differ between trials .
-CONCLUSIONS	These data indicate that acute tyrosine administration did not influence self-paced endurance exercise performance in the heat .
-CONCLUSIONS	Plasma tyrosine availability is apparently not a key determinant of fatigue processes under these conditions .
-
-###25106891
-OBJECTIVE	The aim of this study was to investigate the effects of gonadotropin releasing hormone analog ( GnRHa ) therapy on normalized testicular atrophy index ( TAIn ) using gonadorelin before and after orchiopexy .
-METHODS	62 infants with 87 undescended testes ( UDT ) were prospectively assigned to two homogeneous groups according to age , position of UDT and TAIn .
-METHODS	The patients were randomized to receive either orchiopexy alone or orchiopexy combined with GnRHa as nasal spray at 1.2 mg daily for 4 weeks before surgery and 4 weeks after surgery .
-METHODS	Surgical approaches were relative to the position of the UDT : Shoemakers technique in proximal-UDT and Bianchi technique in distal-UDT .
-METHODS	All the patients were evaluated clinically and sonographically 1 month before surgery , at the time of surgery , 1 month , 6 months and 5 years after surgery .
-RESULTS	Ultrasound data in our study have shown a statistically significant decrease of TAIn in children given additional HT only after 5 years of follow-up , in unilateral cases and in the entirety of treated patients ; in bilateral cases this difference was not statistically significant .
-CONCLUSIONS	Patients with a TAIn > 20 % treated with preoperative and post-operative GnRHa therapy have a significant increase in testicular volume after 5 years of follow-up , as shown by the relative reduction of TAIn values .
-
-###25492496
-BACKGROUND	To improve the translation of public health evidence into practice , there is a need to increase practitioner involvement in initiative development , to place greater emphasis on contextual knowledge , and to address intervention processes and outcomes .
-BACKGROUND	Evidence that demonstrates the need to reduce childhood fire-related injuries is compelling but its translation into practice is inconsistent and limited .
-BACKGROUND	With this knowledge the Keeping Children Safe programme developed an `` Injury Prevention Briefing ( IPB ) '' using a 7 step process to combine scientific evidence with practitioner contextual knowledge .
-BACKGROUND	The IPB was designed specifically for children 's centres ( CCs ) to support delivery of key fire safety messages to parents .
-BACKGROUND	This paper reports the findings of a nested qualitative study within a clustered randomised controlled trial of the IPB , in which staff described their experiences of IPB implementation to aid understanding of why or how the intervention worked .
-METHODS	Interviews were conducted with key staff at 24 CCs participating in the two intervention arms : 1 ) IPB supplemented by initial training and regular facilitation ; 2 ) IPB sent by post with no facilitation .
-METHODS	Framework Analysis was applied to these interview data to explore intervention adherence including ; exposure or dose ; quality of delivery ; participant responsiveness ; programme differentiation ; and staff experience of IPB implementation .
-METHODS	This included barriers , facilitators and suggested improvements .
-RESULTS	83 % of CCs regarded the IPB as a simple , accessible tool which raised awareness , and stimulated discussion and behaviour change .
-RESULTS	15 CCs suggested minor modifications to format and content .
-RESULTS	Four levels of implementation were identified according to content , frequency , duration and coverage .
-RESULTS	Most CCs ( 75 % ) achieved ` extended ' or ` essential ' IPB implementation .
-RESULTS	Three universal factors affected all CCs : organisational change and resourcing ; working with hard to engage groups ; additional demands of participating in a research study .
-RESULTS	Six specific factors were associated with the implementation level achieved : staff engagement and training ; staff continuity ; adaptability and flexibility ; other agency support ; conflicting priorities ; facilitation .
-RESULTS	CCs achieving high implementation levels increased from 58 % ( no facilitation ) to 92 % with facilitation .
-CONCLUSIONS	Incorporating service provider perspectives and scientific evidence into health education initiatives enhances potential for successful implementation , particularly when supplemented by ongoing training and facilitation .
-
-###25044988
-METHODS	To determine whether the insulin resistance that exists in metabolic syndrome ( MetS ) patients is modulated by dietary fat composition .
-RESULTS	Seventy-five patients were randomly assigned to one of four diets for 12 wk : high-saturated fatty acids ( HSFAs ) , high-MUFA ( HMUFA ) , and two low-fat , high-complex carbohydrate ( LFHCC ) diets supplemented with long-chain n-3 ( LFHCC n-3 ) PUFA or placebo .
-RESULTS	At the end of intervention , the LFHCC n-3 diet reduced plasma insulin , homeostasis model assessment of insulin resistance , and nonsterified fatty acid concentration ( p < 0.05 ) as compared to baseline Spanish habitual ( BSH ) diet .
-RESULTS	Subcutaneous white adipose tissue ( WAT ) analysis revealed decreased EH-domain containing-2 mRNA levels and increased cbl-associated protein gene expression with the LFHCC n-3 compared to HSFA and HMUFA diets , respectively ( p < 0.05 ) .
-RESULTS	Moreover , the LFHCC n-3 decreased gene expression of glyceraldehyde-3-phosphate dehydrogenase with respect to HMUFA and BSH diets ( p < 0.05 ) .
-RESULTS	Finally , proteomic characterization of subcutaneous WAT identified three proteins of glucose metabolism downregulated by the LFHCC n-3 diet , including annexin A2 .
-RESULTS	RT-PCR analysis confirmed the decrease of annexin A2 ( p = 0.027 ) after this diet .
-CONCLUSIONS	Our data suggest that the LFHCC n-3 diet reduces systemic insulin resistance and improves insulin signaling in subcutaneous WAT of MetS patients compared to HSFA and BSH diets consumption .
-
-###25129333
-BACKGROUND	The outcomes of acute cardiovascular symptom presentations are potentially modifiable with the use of biomarkers to accelerate accurate diagnosis .
-BACKGROUND	This randomized trial tested troponin and B-type natriuretic peptide before hospital guidance in patients with acute cardiovascular symptoms .
-METHODS	Patients with either chest pain or shortness of breath were randomized to usual care or biomarkers analyzed using a point-of-care device in the ambulance .
-METHODS	The primary end point was time to final disposition ( discharge from the emergency department or admission to hospital ) .
-METHODS	The trial was stopped prematurely because of less than expected enrollment of patients of interest and no difference in the primary end point .
-RESULTS	We randomized 491 patients ; 480 formed the final cohort .
-RESULTS	Patients were 49 % male ; median age 70 years ; 42 % had previous acute coronary syndrome ; and 28 % diabetes .
-RESULTS	The B-type natriuretic peptide level before hospital arrival was 100 pg/mL in 36.4 % .
-RESULTS	Troponin was > 0.03 ng/mL in 13.4 % ; 3.6 % had troponin > 0.1 ng/mL .
-RESULTS	After adjudication , 16 % had acute coronary syndrome , 6.5 % acute heart failure , 3.3 % angina , and 74.2 % another diagnosis .
-RESULTS	The primary end point was 9.2 ( interquartile range , 7.3-11 .1 ) hours in the biomarker group and 8.8 ( interquartile range , 6.3-12 .1 ) hours in the usual care group ( P = 0.6 ) .
-RESULTS	None died in the ambulance or in the emergency department : all-cause 30-day mortality was 2.1 % ( usual care ) and 1.7 % ( biomarker ) .
-CONCLUSIONS	To our knowledge , this is the first randomized trial of biomarkers before hospital arrival to guide emergency management of suspected acute cardiovascular disease which showed no benefit and was terminated early because of futility .
-CONCLUSIONS	The results have important implications for the use of biomarkers in emergency management of heart disease and for the design of future randomized trials on this important topic .
-
-###24646429
-BACKGROUND	Medication-overuse headache ( MOH ) is a common problem in primary care .
-BACKGROUND	Brief intervention ( BI ) has successfully been used for detoxification from overuse of alcohol and drugs .
-BACKGROUND	The aim of this pilot study was to develop and test methodology , acceptability and logistics for a BI for MOH in primary care .
-RESULTS	Observational feasibility study of an intervention in a Norwegian general practice population.Six general practitioners ( GPs ) were recruited .
-RESULTS	A screening questionnaire for MOH was sent to all 18-50 year old patients on these GPs ` list .
-RESULTS	GPs were taught BI , which was applied to MOH patients as follows : Severity of dependence scale ( SDS ) scores were collected and individual feedback was given of the relationship between the SDS , medication overuse and headache .
-RESULTS	Finally , advice to reduce medication was given .
-RESULTS	Patients were invited to a headache interview three months after the BI .
-RESULTS	Main outcomes were feedback from GPs/patients about the feasibility and logistics of the study design , screening/recruitment process , BI and headache interviews .
-RESULTS	Efficacy and patient-related outcomes were not focused .
-RESULTS	The patients reported a high degree of acceptability of the methodology .
-RESULTS	The GPs reported the BI to be feasible to implement within a busy practice and to represent a new and improved instrument for communication with MOH patients .
-RESULTS	The BI requires further testing in a randomised controlled trial ( RCT ) in order to provide evidence of efficacy .
-CONCLUSIONS	This feasibility study will be used to improve the BI for MOH and the design of a cluster-RCT .
-BACKGROUND	ClinicalTrials.gov : NCT01078012 ( Initially registered as controlled efficacy trial but changed to observational study ) .
-
-###25143169
-OBJECTIVE	To observe the effects of intra-operative combined dosing of dezoxine and dexmedetomidine on sedation , analgesia and the incidence of untoward events during and after surgery in teenagers undergoing horizontal concomitant strabismus surgery .
-METHODS	For this prospective and randomized trial , approval was obtained from the Ethical Committee and informed consent from their parents .
-METHODS	A total of 60 patients aged 10-16 years undergoing strabismus surgery at Second Affiliated Hospital from September to December 2013 were collected .
-METHODS	The treatment group received an intravenous dose of dezoxine 0.1 mgkg ( -1 ) at 15 minutes before surgery .
-METHODS	And another intravenous injection of dexmedetomidine was administered at 0.4 gkg ( -1 ) h ( -1 ) until the end of the first ocular muscle correcting .
-METHODS	The control group received the same volume of normal saline .
-METHODS	Observational parameters including visual analogue scale ( VAS ) , Ramsay scores , self-rating anxiety scale ( SAS ) , heart rate ( HR ) , blood pressure and the incidence of untoward events such as nausea and vomiting or arrhythmia were recorded .
-RESULTS	The VAS pain scores in the treatment group at T2-T5 decreased significantly versus the control group ( P < 0.05 ) .
-RESULTS	The Ramsay scores in the treatment group at T2-T3 increased and significantly differences existed with the control group ( P < 0.05 ) .
-RESULTS	SAS scores showed significant differences between pre-operative and post-operative periods in the treatment group ( P < 0.05 ) .
-RESULTS	The treatment group has shorter operative duration with 5 cases of dragging pain in the treatment group versus 25 in the control group ( P < 0.05 ) .
-RESULTS	During dragging reflex , HR was lower in the control group at T2 and T3 .
-RESULTS	There were significant differences with the control group ( P < 0.05 ) .
-CONCLUSIONS	A combination of dezoxine and dexmedetomidine provide multiple benefits for patients undergoing strabismus surgery .
-CONCLUSIONS	Compared with simple local anesthesia , it effectively attenuates pain and anxiety and provides mild sedation and better cooperation during strabismus surgery .
-
-###25226826
-OBJECTIVE	Eicosapentaenoic acid ( EPA ) , which may reduce the risk for coronary heart disease ( CHD ) , can be synthesized at low rates from - linolenic acid ( ALA ) .
-OBJECTIVE	The rate-limiting step for this conversion is the 6-desaturation of ALA into stearidonic acid ( SDA ) .
-OBJECTIVE	Thus providing oils rich in SDA may increase endogenous synthesis of EPA , which may subsequently lower serum triacylglycerol concentrations , an effect frequently observed after EPA supplementation .
-OBJECTIVE	We therefore studied the effects of Echium oil on serum triacylglycerol concentrations and the omega-3 index , which correlate negatively with the risk for CHD .
-METHODS	A randomized , double-blind , placebo-controlled crossover trial was conducted , in which 36 healthy overweight and slightly obese subjects daily received 10 g of Echium oil ( providing 1.2 g of SDA ) or a high oleic acid sunflower oil ( HOSO ) as control for 6 weeks , with a washout period of at least 14 days .
-METHODS	Four subjects dropped out .
-METHODS	Differences between periods were tested for statistical significance ( P < 0.05 ) using a paired t-test .
-RESULTS	Serum triacylglycerol and other lipid concentrations were not significantly affected by consumption of Echium oil compared with HOSO .
-RESULTS	Echium oil significantly increased percentage of EPA in red blood cell ( RBC ) membranes with 0.14 0.25 % ( mean s.d. ) compared with HOSO ( P = 0.02 ) .
-RESULTS	No significant effects on docosahexaenoic acid in RBC membranes or on the omega-3 index were found .
-CONCLUSIONS	In healthy overweight and slightly obese subjects , an increased intake of SDA from Echium oil does not lower serum triacylglycerol concentrations .
-CONCLUSIONS	Despite an increase in the percentage of EPA in RBC membranes , the omega-3 index was not changed .
-
-###24280442
-OBJECTIVE	Huai Qi Huang ( HQH ) is a compound Chinese herbal medicine that contains Trametes robiniophila murr , wolfberry fruit , and Polygonatum .
-OBJECTIVE	In the present study , we investigated the effects of HQH on patients with mild immunoglobulin A nephropathy ( IgAN ) through a prospective randomized controlled study .
-METHODS	Forty-five adults diagnosed with IgAN according to renal pathology , who had hematuria or/and proteinuria ( 2 g/day ) , were randomly assigned to receive HQH or no treatment for 12 weeks .
-METHODS	Twenty-four hour urinary protein excretion and hematuria were measured at Weeks 0 , 4 , 8 , and 12 .
-METHODS	The rate of complete remission of proteinuria and hematuria was evaluated .
-METHODS	Any adverse events induced by HQH were also observed during the treatment period .
-RESULTS	Twenty-four hour urinary protein excretion was significantly reduced by HQH treatment compared with that in the control group at Weeks 8 and 12 .
-RESULTS	A much higher rate of complete remission of proteinuria was observed in the HQH group than in control group at Week 12 .
-RESULTS	HQH administration also obviously reduced the extent of hematuria compared with that in the control group at Week 12 .
-RESULTS	HQH treatment dramatically increased the rate of complete remission of hematuria compared with that in control group at Weeks 8 and 12 .
-RESULTS	No obvious adverse events caused by HQH were observed .
-CONCLUSIONS	HQH could be a new conservative therapy for IgAN patients who can not tolerate steroids and immunosuppressive agents .
-CONCLUSIONS	The relapse rate after discontinuing treatment still needs further investigation .
-
-###25684164
-BACKGROUND	Extracranial carotid and vertebral artery dissection is an important cause of stroke , especially in young people .
-BACKGROUND	In some observational studies it has been associated with a high risk of recurrent stroke .
-BACKGROUND	Both antiplatelet drugs and anticoagulant drugs are used to reduce risk of stroke but whether one treatment strategy is more effective than the other is unknown .
-BACKGROUND	We compared their efficacy in the Cervical Artery Dissection in Stroke Study ( CADISS ) , with the additional aim of establishing the true risk of recurrent stroke .
-METHODS	We did this randomised trial at hospitals with specialised stroke or neurology services ( 39 in the UK and seven in Australia ) .
-METHODS	We included patients with extracranial carotid and vertebral dissection with onset of symptoms within the past 7 days .
-METHODS	Patients were randomly assigned ( 1:1 ) by an automated telephone randomisation service to receive antiplatelet drugs or anticoagulant drugs ( specific treatment decided by the local clinician ) for 3 months .
-METHODS	Patients and clinicians were not masked to allocation , but investigators assessing endpoints were .
-METHODS	The primary endpoint was ipsilateral stroke or death in the intention-to-treat population .
-METHODS	The trial was registered with EUDract ( 2006-002827-18 ) and ISRN ( CTN44555237 ) .
-RESULTS	We enrolled 250 participants ( 118 carotid , 132 vertebral ) .
-RESULTS	Mean time to randomisation was 365 days ( SD 191 ) .
-RESULTS	The major presenting symptoms were stroke or transient ischaemic attack ( n = 224 ) and local symptoms ( headache , neck pain , or Horner 's syndrome ; n = 26 ) .
-RESULTS	126 participants were assigned to antiplatelet treatment versus 124 to anticoagulant treatment .
-RESULTS	Overall , four ( 2 % ) of 250 patients had stroke recurrence ( all ipsilateral ) .
-RESULTS	Stroke or death occurred in three ( 2 % ) of 126 patients versus one ( 1 % ) of 124 ( odds ratio [ OR ] 0335 , 95 % CI 0006-4233 ; p = 063 ) .
-RESULTS	There were no deaths , but one major bleeding ( subarachnoid haemorrhage ) in the anticoagulant group .
-RESULTS	Central review of imaging failed to confirm dissection in 52 patients .
-RESULTS	Preplanned per-protocol analysis excluding these patients showed stroke or death in three ( 3 % ) of 101 patients in the antiplatelet group versus one ( 1 % ) of 96 patients in the anticoagulant group ( OR 0346 , 95 % CI 0006-4390 ; p = 066 ) .
-CONCLUSIONS	We found no difference in efficacy of antiplatelet and anticoagulant drugs at preventing stroke and death in patients with symptomatic carotid and vertebral artery dissection but stroke was rare in both groups , and much rarer than reported in some observational studies .
-CONCLUSIONS	Diagnosis of dissection was not confirmed after review in many cases , suggesting that radiographic criteria are not always correctly applied in routine clinical practice .
-BACKGROUND	Stroke Association .
-
-###25626811
-BACKGROUND	The purpose of this study was to investigate the efficacy of eyelid cooling to reduce postoperative pain , edema , erythema , and hematoma after upper blepharoplasty .
-METHODS	After bilateral upper blepharoplasty in 38 consecutive patients , one eyelid per patient was randomized for cooling with an ice pack , and the other eyelid was left uncooled .
-METHODS	Pain was scored by the patients using a visual analogue scale ( 0 to 10 ) 1 hour and 1 day after surgery .
-METHODS	Degree of edema , erythema , and hematoma were scored by the patients on a four-point rating scale ( no , minimal , moderate , or severe ) 1 hour , 1 day , 1 week , and 2 months after surgery .
-METHODS	Light photography was obtained 1 week after surgery for scoring the degree of bruising on a four-point rating scale by a blinded observer .
-RESULTS	Pain did not differ between cooled and uncooled eyelids on the day of surgery .
-RESULTS	However , pain in cooled eyelids was significantly lower 1 day after surgery ( p = 0.046 ) , yet absolute pain scores were low ( median , 0 and 0.5 , on a scale of 10 ) .
-RESULTS	Edema , erythema , or hematoma did not differ between cooled and uncooled eyelids on any of the time points studied .
-CONCLUSIONS	Cooling of eyelids after upper blepharoplasty does not reduce edema , erythema , or hematoma of the eyelids , but reduces pain 1 day after surgery .
-CONCLUSIONS	However , because the degree of pain seems clinically irrelevant and because the majority of patients indicate that they have no preference for cooling over noncooling , eyelid cooling after upper blepharoplasty as a rule of thumb can be abandoned .
-METHODS	Therapeutic , II .
-
-###24364989
-BACKGROUND	There is limited evidence to support the use of facemasks in preventing infection for primary care professionals .
-BACKGROUND	Negative effects on communication has been suggested when the physician wears a facemask .
-BACKGROUND	As communication skills and doctor patient relationship are essential to primary care consultations , the effects of doctor 's facemask wearing were explored .
-METHODS	A randomised controlled study was conducted in primary care to explore the effects of doctors wearing facemasks on patients ' perception of doctors ' empathy , patient enablement and patient satisfaction .
-METHODS	Primary care doctors were randomized to mask wearing and non mask wearing clinical consultations in public primary care clinics in Hong Kong .
-METHODS	Patients ' views were gathered using the Consultation and Relational Empathy ( CARE ) Measure , Patient Enablement Instrument ( PEI ) and an overall satisfaction rating scale .
-METHODS	The effects of face mask wearing were investigated using multilevel ( hierarchical ) modelling .
-RESULTS	1,030 patients were randomised to doctor-mask wearing consultations ( n = 514 ) and non mask wearing consultations ( n = 516 ) .
-RESULTS	A significant and negative effect was found in the patients ' perception of the doctors ' empathy ( CARE score reduction -0.98 , p-value = 0.04 ) .
-RESULTS	In the more established doctor-patient relationship , the effect of doctors ' mask wearing was more pronounced ( CARE score reduction -5.67 , p-value = 0.03 ) .
-CONCLUSIONS	This study demonstrates that when doctors wearing a facemask during consultations , this has a significant negative impact on the patient 's perceived empathy and diminish the positive effects of relational continuity .
-CONCLUSIONS	Consideration should be taken in planning appropriate use of facemasks in infectious disease policy for primary care and other healthcare professionals at a national , local or practice level .
-BACKGROUND	This trial was registered on Chinese Clinical Trial Register ( ChiCTR ) .
-BACKGROUND	Registration no. : ChiCTR-TTRCC-12002519 .
-BACKGROUND	URL : http://www.chictr.org/en/proj/show.aspx?proj=3486 .
-BACKGROUND	Due to administrative error , registration of trial did not take place until after the trial started on 1st August 2011 and registration number was released on 21st September 2012 .
-
-###24259750
-BACKGROUND	Limited ankle joint dorsiflexion passive range of motion ( PROM ) has been associated with common chronic lower extremity conditions , and clinicians often instruct patients in stretching exercises to increase dorsiflexion .
-BACKGROUND	However , little is known about how subtalar joint ( STJ ) position affects dorsiflexion at the midfoot/forefoot versus ankle/rearfoot during gastrocnemius stretching .
-BACKGROUND	The purpose of this study was to determine if more dorsiflexion occurs at the ankle/rearfoot and less at the midfoot/forefoot during gastrocnemius stretching with the STJ positioned in supination versus pronation .
-METHODS	In this repeated measures design , 27 participants ( 23 females , 4 males ; mean age = 31.3 years , SD = 10.7 ) with current or recent history of lower extremity chronic conditions and less than 10 degrees ankle dorsiflexion measured with the knee in extension on the involved side ( s ) performed five 30-second gastrocnemius stretching trials in pronation and supination on each side in a randomly determined sequence .
-METHODS	A 7-camera Vicon Motion Analysis System and an AMTI force plate were used to measure midfoot/forefoot dorsiflexion , ankle/rearfoot dorsiflexion , knee extension , and normalized vertical ground reaction force .
-RESULTS	Two-way repeated measures ANOVA revealed a significant increase in midfoot/forefoot dorsiflexion when stretching in pronation compared to supination ( P < .001 ) .
-RESULTS	ANOVAs also demonstrated significantly more extension of the knee when stretching in supination compared to pronation ( P < .001 ) , and increased normalized vertical ground reaction force when stretching in supination compared to pronation ( P = .032 ) .
-RESULTS	With the numbers available , no significant difference in ankle/rearfoot dorsiflexion when stretching in supination compared to pronation could be detected ( P > .05 ) .
-CONCLUSIONS	Gastrocnemius stretching in pronation resulted in more dorsiflexion at the midfoot/forefoot than stretching in supination .
-CONCLUSIONS	Clinicians may want to consider STJ position during gastrocnemius stretching to either facilitate or limit recruitment of dorsiflexion motion at the midfoot/forefoot .
-
-###25057102
-BACKGROUND	Cryptococcal meningitis is the most common cause of adult meningitis in sub-Saharan Africa .
-BACKGROUND	Raised intracranial pressure ( ICP ) is common in cryptococcosis .
-BACKGROUND	Prior studies suggest elevated ICP is associated with mortality , and guidelines recommend frequent lumbar punctures ( LPs ) to control ICP .
-BACKGROUND	However , the magnitude of the impact of LPs on cryptococcal-related mortality is unknown .
-METHODS	In sum , 248 individuals with human immunodeficiency virus ( HIV ) - associated cryptococcal meningitis , screened for the Cryptococcal Optimal ART Timing ( COAT ) trial in Uganda and South Africa , were observed .
-METHODS	Individuals received an LP to diagnose meningitis , and subsequent therapeutic LPs were recommended for elevated ICP ( > 250 mmH2O ) or new symptoms .
-METHODS	We compared survival , through 11 days , between individuals receiving at least 1 therapeutic LP with individuals not receiving therapeutic LPs .
-METHODS	The COAT trial randomized subjects at 7-11 days ; thus , follow-up stopped at time of death , randomization , or 11 days .
-RESULTS	Seventy-five ( 30 % ) individuals had at least 1 therapeutic LP .
-RESULTS	Individuals receiving therapeutic LPs had higher cerebrospinal fluid ( CSF ) opening pressures , higher CSF fungal burdens , and were more likely to have altered mental status at baseline than those with no therapeutic LPs .
-RESULTS	Thirty-one deaths ( 18 % ) occurred among 173 individuals without a therapeutic LP and 5 deaths ( 7 % ) among 75 with at least 1 therapeutic LP .
-RESULTS	The adjusted relative risk of mortality was 0.31 ( 95 % confidence interval : .12 -.82 ) .
-RESULTS	The association was observed regardless of opening pressure at baseline .
-CONCLUSIONS	Therapeutic LPs were associated with a 69 % relative improvement in survival , regardless of initial intracranial pressure .
-CONCLUSIONS	The role of therapeutic LPs should be reevaluated .
-
-###24372810
-BACKGROUND	Angiotensin-converting enzyme inhibitors ( ACEIs ) are currently used to control proteinuria in dogs with chronic kidney disease .
-BACKGROUND	Renal diets ( RDs ) have beneficial effects in the management of azotemic dogs , but its role in proteinuric non-azotemic ( PNAz ) dogs has been poorly documented .
-OBJECTIVE	Administration of a RD to PNAz dogs treated with benazepril ( Be ) improves proteinuria control compared with the administration of a maintenance diet ( MD ) .
-METHODS	Twenty-two PNAz ( urine protein/creatinine ratio [ UPC ] > 1 ) dogs .
-METHODS	Randomized open label clinical trial design .
-METHODS	Dogs were assigned to group-MD ( 5.5 g protein/100 kcal ME ) / Be or to group-RD ( 3.7 g protein/100 kcal ME ) / Be group during 60 days .
-METHODS	Dogs with serum albumin ( Alb ) < 2 g/dL received aspirin ( 1 mg/kg/12 hours ) .
-METHODS	A physical examination , systolic blood pressure ( SBP ) measurement , complete blood count ( CBC ) , biochemistry panel , urinalysis , and UPC were performed at day 0 ( D0 ) and day 60 ( D60 ) .
-RESULTS	At D0 , there were no significant differences between groups in the evaluated variables .
-RESULTS	During the study , logUPC ( geometric mean ( 95 % CI ) and SBP ( meanSD mmHg ) significantly decreased ( paired t-test , P = 0.001 ) in Group-RD ( logUPC ( D0 ) = 3.16 [ 1.9-5 .25 ] ; UPC ( D60 ) = 1.20 [ 0.59-2 .45 ] ; SBP ( D0 ) = 160 17.2 ; SBP ( D60 ) = 151 15.8 ) , but not in Group-MD ( UPC ( D0 ) = 3.63 [ 2.69-4 .9 ] ; UPC ( D60 ) = 2.14 [ 0.76-6 .17 ] ; SBP ( D0 ) = 158 14.7 ; SBP ( D60 ) = 153 11.5 ) .
-RESULTS	However , RM-ANOVA test did not confirm that changes were consequence of dietary modification .
-RESULTS	Weight and Alb concentration did not change significantly in any group .
-CONCLUSIONS	The administration of a RD to PNAz dogs treated with Be might help to control proteinuria and SBP compared with the administration of a MD , without inducing clinically detectable malnutrition , but more studies are warranted .
-
-###24957552
-BACKGROUND	To assess the temporal patterns of late gastrointestinal ( GI ) and genitourinary ( GU ) radiotherapy toxicity and resolution rates in a randomised controlled trial ( All-Ireland Cooperative Oncology Research Group 97-01 ) assessing duration of neo-adjuvant ( NA ) hormone therapy for localised prostate cancer .
-METHODS	Node negative patients with > 1 of : PSA > 20 ng/mL , Gleason score 7 , and stage T3 or more , were included .
-METHODS	Follow-up , including toxicity assessment , was three-monthly in the early stages and yearly thereafter .
-RESULTS	Median follow-up from the end of RT was 6.8 years .
-RESULTS	In the interval between 90 days following the end of RT and the last toxicity assessment , GI and GU toxicity ( any grade ) was found in 50 % and 51 % of 240 and 241 patients , respectively .
-RESULTS	For those who did develop toxicity , the median time from end of RT until the first development of any grade GI or GU toxicity was 1.2 years and 1.6 years , respectively , whilst median time to final resolution was 1.6 years and 2.2 years , respectively .
-RESULTS	Grade 2 ( G2 ) or greater GI and GU toxicity occurred in 29 ( 12.1 % ) and 40 ( 16.6 % ) patients , respectively .
-RESULTS	The proportion with unresolved G2 + GI and GU toxicity was 89 % and 79 % , respectively , in year 1 , 69 % and 65 % in year 2 , 59 % and 52 % in year 3 and 27 % and 32 % in year 5 .
-CONCLUSIONS	Long-term toxicities continue to occur many years after NA hormone therapy and RT. .
-CONCLUSIONS	The rate of occurrence does not appear to reduce within the time frame during which our patients were followed .
-CONCLUSIONS	The percentage of patients suffering from G2 + toxicity at any time is however low .
-CONCLUSIONS	Resolution of these toxicities continues for the duration of the follow-up .
-
-###25963758
-BACKGROUND	A novel therapeutic management of osteoarthritis ( OA ) of the knee was assessed .
-BACKGROUND	The study aimed to evaluate the effect of monthly sodium bicarbonate with a single ( SBCG1 ) or double dose ( SBCG2 ) of calcium gluconate injections on OA of the knee ; as well as the efficacy and safety of both SBCG interventions in the long term .
-METHODS	A double-blind parallel-group clinical trial with 74 knee OA patients was performed during 12months , both SBCG interventions were followed-up for another 6mo after intervention .
-METHODS	The outcome variables were the Western Ontario-McMaster University Osteoarthritis Index ( WOMAC ) , the Lequesne 's functional index and joint-space width changes from serial radiographs .
-RESULTS	After 12months , group SBCG1 decreased -14.8 ( 95 % CI : -14.2 , -17.0 ) and group SBCG2 decreased -14.6 ( -16.9 , -12.4 ) in the global WOMAC score , the mean changes represent 80 % and 82 % lessened pain , respectively .
-RESULTS	In the Lequesne Functional Index scale , SBCG1 decreased -11.9 ( -10.4 , -14.2 ) and SBCG2 decreased -11.9 ( -13.8 , -10.0 ) , representing 66 and 69 % of improvement .
-RESULTS	Both mean scores were maintained after intervention discontinued .
-RESULTS	SBCG2 improved the knees ' joint space width more than SBCG1 at 3 and 18months .
-RESULTS	Both SBCG interventions were well tolerated after 12months of treatment
-CONCLUSIONS	A solution of sodium bicarbonate and calcium gluconate is effective on reducing the symptoms associated with OA .
-CONCLUSIONS	Its beneficial effect is maintained for one year of continuous monthly administration and at least for 6months after the administration is discontinued .
-CONCLUSIONS	When the dose of calcium gluconate is increased , it prevents further narrowing of joint-space .
-BACKGROUND	Clinicaltrials.gov NCT00977444 September 11 , 2009 .
-
-###25610905
-BACKGROUND	Deprivation of parents might decrease self-esteem ( SE ) and result in affective and social incompatibility .
-BACKGROUND	In this randomized control trial , we examined the effect of aerobics exercise on SE among female adolescents living with no natural family .
-METHODS	The sample consisted of all female adolescents aged 13 to 19 years ( n : 72 ) who were covered by Isfahan Welfare organization .
-METHODS	Participants were assigned into intervention and control groups by matched random sampling .
-METHODS	Intervention included 8 weeks of aerobics exercise .
-METHODS	Coppersmith SE inventory was administered before and after intervention as well as after one month follow-up .
-RESULTS	No significant difference was seen between pre-SE scores of intervention ( 32.7 8.4 ) and control ( 33.0 6.7 ) groups ( t = .16 , P = .87 ) .
-RESULTS	A significant difference was obtained in post-SE scores ( 40.2 5.7 versus 34.7 6.8 , t = 3.58 , P = .001 ) and in one month follow-up scores ( 36.4 5.2 versus 33.0 5.2 , t = 2.25 , P = .03 ) .
-CONCLUSIONS	The results demonstrated a low level of pre-SE in both groups .
-CONCLUSIONS	However , a significant improvement was seen in posttest of intervention group which persisted even one month after intervention .
-CONCLUSIONS	It supports the use of aerobics for female adolescents deprived from family life .
-
-###25909236
-OBJECTIVE	To evaluate the effect of oral supplementation with omega-3 ( -3 ) fatty acids ( FAs ) in improving contrast sensitivity ( CS ) of patients with moderate meibomian gland dysfunction ( MGD ) .
-METHODS	In this prospective study , 60 patients with moderate MGD were allocated alternately to treatment and control groups .
-METHODS	Both groups received warm compresses , lid massage , and artificial tear substitutes .
-METHODS	The treatment group also received oral supplements of 1.2 g -3 FAs per day .
-METHODS	All parameters were recorded at baseline and at 12 weeks and included Ocular Surface Disease Index scores , CS testing at 3 , 6 , 12 , and 18 cycles per degree ( cpd ) , tear break-up time , Schirmer test I without anesthesia , corneal and conjunctival staining scores , and meibum quality and expressibility .
-RESULTS	At the end of 12 weeks , significant improvement in CS was seen in the treatment group in 7 of the 8 testing conditions ( 3 , 6 , 12 , and 18 cpd photopic and 6 , 12 , and 18 cpd mesopic ) , whereas in the placebo group , significant improvement was seen only in 3 of the 8 testing conditions ( 3 cpd photopic , 6 and 18 cpd mesopic ) .
-RESULTS	Ocular Surface Disease Index , tear break-up time , ocular surface staining , and meibum quality and expressibility improved significantly in both groups , but more so in the treatment group .
-RESULTS	Schirmer scores showed no significant improvement in either group .
-CONCLUSIONS	Oral supplementation with -3 FAs significantly improved CS under both photopic and mesopic testing conditions in patients with moderate MGD .
-CONCLUSIONS	Tear film stability also improved significantly , whereas no effect was seen on aqueous tear production .
-
-###24794720
-OBJECTIVE	Concern about pain during placement of an intrauterine device ( IUD ) represents a barrier to use , especially among nulliparous women .
-OBJECTIVE	We hypothesized that nitroglycerin gel applied vaginally 30 min prior to IUD placement would reduce insertion-related pain .
-METHODS	We designed a randomized , double-blinded , placebo-controlled pilot study to evaluate the efficacy and tolerability of 0.5-mg nitroglycerin gel ( 1 mL ) or identical placebo gel applied vaginally in nulliparous women 30 min prior to IUD placement .
-METHODS	The study was limited to women who opted for the levonorgestrel-releasing intrauterine system .
-METHODS	Subjects completed a series of 100-mm visual analogue scales at several time points .
-METHODS	The primary outcome was subject-reported pain with passage of the IUD through the cervix .
-METHODS	Secondary outcomes included subject-reported pain at other time points , provider-reported ease of insertion , side effects , adverse events and need for additional dilation .
-RESULTS	A total of 24 women were randomized .
-RESULTS	Baseline characteristics were similar between groups .
-RESULTS	The mean pain score with IUD deployment was 55.0 mm [ standard deviation ( SD ) = 29.7 mm ] in the placebo group and 57.4 mm ( SD 22.1 mm ) in the nitroglycerin group ( p = .82 ) .
-RESULTS	There was no difference in ease of insertion reported by providers .
-RESULTS	Two subjects required dilation , one in each group .
-CONCLUSIONS	Vaginal administration of 0.5-mg nitroglycerin gel 30 min prior to IUD placement does not appear to decrease patient-reported procedural pain among nulliparous women or ease of insertion for providers .
-
-###24803436
-BACKGROUND	Long-term clinical outcomes of everolimus-eluting stent ( EES ) compared with sirolimus-eluting stent ( SES ) have not been evaluated fully yet , especially whether EES implantation could positively affect late adverse events reported after SES implantation occurring > 1 year .
-RESULTS	In this all-comer prospective multicenter randomized open-label trial , 3196 patients were assigned randomly to implant either EES ( n = 1596 ) or SES ( n = 1600 ) .
-RESULTS	At 3 years , EES was noninferior to SES on the primary safety end point ( all-cause death or myocardial infarction ; 10.1 % versus 11.5 % ; noninferiority P < 0.001 ; and superiority P = 0.19 ) .
-RESULTS	Cumulative incidence of definite stent thrombosis was low and was not significantly different between the 2 groups ( 0.5 % versus 0.6 % ; P = 0.81 ) .
-RESULTS	There was no significant difference in the efficacy end point of target-lesion revascularization between the EES and SES groups ( 6.6 % versus 7.9 % ; P = 0.16 ) .
-RESULTS	However , the cumulative incidence of target-lesion failure ( cardiac death/target-vessel myocardial infarction/ischemia-driven target-lesion revascularization ) was significantly lower in the EES group than in the SES group ( 8.8 % versus 11.4 % ; P = 0.01 ) .
-RESULTS	By a landmark analysis at 1 year , the cumulative incidence of very late stent thrombosis and late target-lesion revascularization was not significantly different between the 2 groups ( 0.2 % versus 0.2 % ; P = 0.99 and 2.2 % versus 2.9 % ; P = 0.21 , respectively ) .
-CONCLUSIONS	The efficacy and safety outcomes for this trial after EES implantation remained comparable with those after SES implantation through 3-year follow-up .
-CONCLUSIONS	However , improvement of clinical outcome after EES implantation compared with SES implantation was suggested by the significantly lower cumulative incidences of target-lesion failure , which has been the most widely used primary end point in the stent-versus-stent trials .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01035450 .
-
-###24676651
-BACKGROUND	Metamizole use has been limited because of its risk of agranulocytosis .
-BACKGROUND	However , more recent literature seems to support its safety .
-BACKGROUND	This prospective , randomised , double-blind study was conducted to compare the analgesic effects of intravenous metamizole or intravenous paracetamol in combination with morphine PCA during the first 24h following total hip arthroplasty .
-METHODS	One hundred ten consecutive patients were selected for study .
-METHODS	The two study groups were ( A ) metamizole , ( B ) paracetamol .
-METHODS	Postoperative pain therapy was provided by Morphine PCA pump .
-METHODS	In the first treatment group ( A group ) , all patients received intravenous metamizole 1.5 g every 8h during the first 24 postoperative hours .
-METHODS	In the second treatment group ( B group ) , all patients received intravenous paracetamol 1g every 8h during the first 24 postoperative hours .
-METHODS	Postoperative pain intensity was measured 1 , 2 , 3 , 4 , 6 , 8 , 10 , 14 , 18 , 22h after the end of surgery by a VAS .
-RESULTS	Statistically significant differences in VAS pain values favoring metamizole were reported at 6-h ( p = 0.038 ) , 8-h ( p = 0.036 ) , 14-h ( p = 0.011 ) , 18-h ( p < 0.001 ) and 22-h ( p = 0.025 ) post-baseline .
-RESULTS	Mean cumulative pain values were 17.9 for metamizole and 30.6 for paracetamol .
-CONCLUSIONS	In this study , we have also shown excellent efficacy of paracetamol and metamizole combined with opioids , but metamizole proved to be a better analgesic than paracetamol .
-CONCLUSIONS	It is also necessary to mention the financial aspect considering that intravenous paracetamol is about ten times more expensive than an equivalent analgesic doses of intravenous metamizole .
-
-###25072396
-BACKGROUND	A malaria vaccine could be an important addition to current control strategies .
-BACKGROUND	We report the safety and vaccine efficacy ( VE ) of the RTS , S/AS01 vaccine during 18 mo following vaccination at 11 African sites with varying malaria transmission .
-RESULTS	6,537 infants aged 6-12 wk and 8,923 children aged 5-17 mo were randomized to receive three doses of RTS , S/AS01 or comparator vaccine .
-RESULTS	VE against clinical malaria in children during the 18 mo after vaccine dose 3 ( per protocol ) was 46 % ( 95 % CI 42 % to 50 % ) ( range 40 % to 77 % ; VE , p < 0.01 across all sites ) .
-RESULTS	VE during the 20 mo after vaccine dose 1 ( intention to treat [ ITT ] ) was 45 % ( 95 % CI 41 % to 49 % ) .
-RESULTS	VE against severe malaria , malaria hospitalization , and all-cause hospitalization was 34 % ( 95 % CI 15 % to 48 % ) , 41 % ( 95 % CI 30 % to 50 % ) , and 19 % ( 95 % CI 11 % to 27 % ) , respectively ( ITT ) .
-RESULTS	VE against clinical malaria in infants was 27 % ( 95 % CI 20 % to 32 % , per protocol ; 27 % [ 95 % CI 21 % to 33 % ] , ITT ) , with no significant protection against severe malaria , malaria hospitalization , or all-cause hospitalization .
-RESULTS	Post-vaccination anti-circumsporozoite antibody geometric mean titer varied from 348 to 787 EU/ml across sites in children and from 117 to 335 EU/ml in infants ( per protocol ) .
-RESULTS	VE waned over time in both age categories ( Schoenfeld residuals p < 0.001 ) .
-RESULTS	The number of clinical and severe malaria cases averted per 1,000 children vaccinated ranged across sites from 37 to 2,365 and from -1 to 49 , respectively ; corresponding ranges among infants were -10 to 1,402 and -13 to 37 , respectively ( ITT ) .
-RESULTS	Meningitis was reported as a serious adverse event in 16/5 ,949 and 1/2 ,974 children and in 9/4 ,358 and 3/2 ,179 infants in the RTS , S/AS01 and control groups , respectively .
-CONCLUSIONS	RTS , S/AS01 prevented many cases of clinical and severe malaria over the 18 mo after vaccine dose 3 , with the highest impact in areas with the greatest malaria incidence .
-CONCLUSIONS	VE was higher in children than in infants , but even at modest levels of VE , the number of malaria cases averted was substantial .
-CONCLUSIONS	RTS , S/AS01 could be an important addition to current malaria control in Africa .
-BACKGROUND	www.ClinicalTrials.gov NCT00866619 Please see later in the article for the Editors ' Summary .
-
-###25442655
-OBJECTIVE	The purpose of this study was to examine the osteotomy gap filling rate with new bone after open wedge high tibial osteotomy ( HTO ) without bone graft and the effects of smoking , lateral hinge fracture , and early full weight bearing .
-METHODS	A prospective series ( N = 70 ) of open wedge HTOs with the TomoFix plate ( DePuy Synthes , Umkirch , Germany ) was performed .
-METHODS	Radiologic follow-up examinations took place postoperatively , after 6 and 12 weeks , and after 6 , 12 , and 18 months to measure osteotomy gap filling at each follow-up .
-METHODS	Bone healing was compared in smokers versus nonsmokers who underwent open wedge HTOs with intact lateral hinges .
-METHODS	Fractured lateral hinges were classified according to the Takeuchi classification and separately analyzed regarding bone healing .
-METHODS	Patients were randomly assigned to undergo early ( 11 days ) or standard ( 6 weeks ) full-weight-bearing rehabilitation .
-RESULTS	A delay in the osteotomy gap filling rate between smokers and nonsmokers could be observed at all follow-up periods , but differences were not significant .
-RESULTS	A fracture of the lateral hinge was found in 39 % of the patients .
-RESULTS	A type I fracture was observed in 14 % of patients , a type II fracture was observed in 13 % , and a type III fracture was found in 6 % .
-RESULTS	The highest increase in the osteotomy gap filling rate was observed between 12 weeks and 6 months after surgery in patients with intact lateral hinges .
-RESULTS	For patients with unstable type II fractures , the highest increase in the gap filling rate was delayed until 6 to 12 months .
-RESULTS	Early full weight bearing had no effect on the gap filling rate in any of the patient groups evaluated .
-CONCLUSIONS	This study shows that osteotomy gap filling after open wedge HTO is delayed in smokers and in patients in whom opening of the gap resulted in unstable lateral hinge fractures .
-CONCLUSIONS	Early full weight bearing did not have a significant effect on the gap filling rate .
-METHODS	Level III , prognostic study .
-
-###25610505
-OBJECTIVE	To compare 28-day mortality rates and clinical outcomes in ICU patients with ventilator-associated pneumonia according to the diagnostic strategy used .
-METHODS	This was a prospective randomized clinical trial .
-METHODS	Of the 73 patients included in the study , 36 and 37 were randomized to undergo BAL or endotracheal aspiration ( EA ) , respectively .
-METHODS	Antibiotic therapy was based on guidelines and was adjusted according to the results of quantitative cultures .
-RESULTS	The 28-day mortality rate was similar in the BAL and EA groups ( 25.0 % and 37.8 % , respectively ; p = 0.353 ) .
-RESULTS	There were no differences between the groups regarding the duration of mechanical ventilation , antibiotic therapy , secondary complications , VAP recurrence , or length of ICU and hospital stay .
-RESULTS	Initial antibiotic therapy was deemed appropriate in 28 ( 77.8 % ) and 30 ( 83.3 % ) of the patients in the BAL and EA groups , respectively ( p = 0.551 ) .
-RESULTS	The 28-day mortality rate was not associated with the appropriateness of initial therapy in the BAL and EA groups ( appropriate therapy : 35.7 % vs. 43.3 % ; p = 0.553 ; and inappropriate therapy : 62.5 % vs. 50.0 % ; p = 1.000 ) .
-RESULTS	Previous use of antibiotics did not affect the culture yield in the EA or BAL group ( p = 0.130 and p = 0.484 , respectively ) .
-CONCLUSIONS	In the context of this study , the management of VAP patients , based on the results of quantitative endotracheal aspirate cultures , led to similar clinical outcomes to those obtained with the results of quantitative BAL fluid cultures .
-CONCLUSIONS	( Brazilian Registry of Clinical Trials -- ReBEC ; identification number RBR-86DCDX [ http://www.ensaiosclinicos.gov.br] ) .
-
-###25027140
-OBJECTIVE	Primary Sjgren syndrome is a systemic autoimmune disease characterized by mouth and eye dryness , pain , and fatigue .
-OBJECTIVE	Hydroxychloroquine is the most frequently prescribed immunosuppressant for the syndrome .
-OBJECTIVE	However , evidence regarding its efficacy is limited .
-OBJECTIVE	To evaluate the efficacy of hydroxychloroquine for the main symptoms of primary Sjgren syndrome : dryness , pain , and fatigue .
-METHODS	From April 2008 to May 2011 , 120 patients with primary Sjgren syndrome according to American-European Consensus Group Criteria from 15 university hospitals in France were randomized in a double-blind , parallel-group , placebo-controlled trial .
-METHODS	Participants were assessed at baseline , week 12 , week 24 ( primary outcome ) , and week 48 .
-METHODS	The last follow-up date for the last patient was May 15 , 2012 .
-METHODS	Patients were randomized ( 1:1 ) to receive hydroxychloroquine ( 400 mg/d ) or placebo until week 24 .
-METHODS	All patients were prescribed hydroxychloroquine between weeks 24 and 48 .
-METHODS	The primary end point was the proportion of patients with a 30 % or greater reduction between weeks 0 and 24 in scores on 2 of 3 numeric analog scales ( from 0 [ best ] to 10 [ worst ] ) evaluating dryness , pain , and fatigue .
-RESULTS	At 24 weeks , the proportion of patients meeting the primary end point was 17.9 % ( 10/56 ) in the hydroxychloroquine group and 17.2 % ( 11/64 ) in the placebo group ( odds ratio , 1.01 ; 95 % CI , 0.37-2 .78 ; P = .98 ) .
-RESULTS	Between weeks 0 and 24 , the mean ( SD ) numeric analog scale score for dryness changed from 6.38 ( 2.14 ) to 5.85 ( 2.57 ) in the placebo group and 6.53 ( 1.97 ) to 6.22 ( 1.87 ) in the hydroxychloroquine group .
-RESULTS	The mean ( SD ) numeric analog scale score for pain changed from 4.92 ( 2.94 ) to 5.08 ( 2.48 ) in the placebo group and 5.09 ( 3.06 ) to 4.59 ( 2.90 ) in the hydroxychloroquine group .
-RESULTS	The mean ( SD ) numeric analog scale for fatigue changed from 6.26 ( 2.27 ) to 5.72 ( 2.38 ) in the placebo group and 6.00 ( 2.52 ) to 5.94 ( 2.40 ) in the hydroxychloroquine group .
-RESULTS	All but 1 patient in the hydroxychloroquine group had detectable blood levels of the drug .
-RESULTS	Hydroxychloroquine had no efficacy in patients with anti-SSA autoantibodies , high IgG levels , or systemic involvement .
-RESULTS	During the first 24 weeks , there were 2 serious adverse events in the hydroxychloroquine group and 3 in the placebo group ; in the last 24 weeks , there were 3 serious adverse events in the hydroxychloroquine group and 4 in the placebo group .
-CONCLUSIONS	Among patients with primary Sjgren syndrome , the use of hydroxychloroquine compared with placebo did not improve symptoms during 24 weeks of treatment .
-CONCLUSIONS	Further studies are needed to evaluate longer-term outcomes .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00632866 .
-
-###25558641
-OBJECTIVE	To determine whether plasma sclerostin levels are affected by applying whole-body vibration treatments .
-METHODS	Following a pilot study , the pretsent prospective , randomized , controlled single-blind study was performed on 16 healthy volunteer women ( ages 20 to 40 years ) .
-METHODS	Subjects were randomly divided into 2 groups , and whole-body vibration was applied to the treatment group but not to the controls .
-METHODS	The plasma sclerostin levels were measured before the treatment and at the 10th minute after whole-body vibration on the 1st , 2nd , and 5th days of application .
-RESULTS	The plasma sclerostin level measured at 10 min after the whole-body vibration treatment increased 91 % ( P = 0.024 ) on the 1st day and decreased 31.5 % ( P = 0.03 ) on the 5th day in the whole-body vibration group .
-RESULTS	In the control group , there was no change in the plasma sclerostin level at any time .
-RESULTS	A progressive increase in baseline plasma sclerostin levels during the 5 days of vibration sessions was also found .
-CONCLUSIONS	Our study demonstrated that whole-body vibration can change plasma sclerostin levels , and that this change is detectable 10 min after whole-body vibration treatments .
-
-###25321314
-BACKGROUND	Knowing family history is important for understanding cancer risk , yet communication within families is suboptimal .
-BACKGROUND	Providing strategies to enhance communication may be useful .
-METHODS	Four hundred ninety women were recruited from urban , safety-net , hospital-based primary care women 's health clinics .
-METHODS	Participants were randomized to receive the KinFact intervention or the control handout on lowering risks for breast/colon cancer and screening recommendations .
-METHODS	Cancer family history was reviewed with all participants .
-METHODS	The 20-minute KinFact intervention , based in communication and behavior theory , included reviewing individualized breast/colon cancer risks and an interactive presentation about cancer and communication .
-METHODS	Study outcomes included whether participants reported collecting family history , shared cancer risk information with relatives , and the frequency of communication with relatives .
-METHODS	Data were collected at baseline , 1 , 6 , and 14 months .
-RESULTS	Overall , intervention participants were significantly more likely to gather family cancer information at follow-up ( odds ratio [ OR ] : 2.73 ; 95 % confidence interval [ CI ] : 2.01 , 3.71 ) and to share familial cancer information with relatives ( OR : 1.85 ; 95 % CI : 1.37 , 2.48 ) .
-RESULTS	Communication frequency ( 1 = not at all ; 4 = a lot ) was significantly increased at follow-up ( 1.67 vs. 1.54 ) .
-RESULTS	Differences were not modified by age , race , education , or family history .
-RESULTS	However , effects were modified by pregnancy status and genetic literacy .
-RESULTS	Intervention effects for information gathering and frequency were observed for nonpregnant women but not for pregnant women .
-RESULTS	Additionally , intervention effects were observed for information gathering in women with high genetic literacy , but not in women with low genetic literacy .
-CONCLUSIONS	The KinFact intervention successfully promoted family communication about cancer risk .
-CONCLUSIONS	Educating women to enhance their communication skills surrounding family history may allow them to partner more effectively with their families and ultimately their providers in discussing risks and prevention .
-
-###25720624
-BACKGROUND	The use of drug-eluting stents ( DES ) in patients at high risk of bleeding or thrombosis has not been prospectively studied ; limited data are available in patients who have a low restenosis risk .
-OBJECTIVE	This study sought to compare a hydrophilic polymer-based , second-generation zotarolimus-eluting stent ( ZES ) with a unique drug fast-release profile versus bare-metal stents ( BMS ) under similar durations of dual-antiplatelet therapy ( DAPT ) .
-METHODS	We randomly assigned 1,606 patients with stable or unstable symptoms , and who on the basis of thrombotic bleeding or restenosis risk criteria , qualified as uncertain candidates for DES , to receive ZES or BMS .
-METHODS	DAPT duration was on the basis of patient characteristics , rather than stent characteristics , and allowed for a personalized 1-month dual antiplatelet regimen .
-METHODS	The primary endpoint was the risk of 1-year major adverse cardiovascular events ( MACE ) , which included death , myocardial infarction ( MI ) , or target vessel revascularization ( TVR ) .
-RESULTS	Median DAPT duration was 32 days ( interquartile range [ IQR ] : 30 to 180 days ) and did not differ between the groups .
-RESULTS	In the ZES group , 140 patients ( 17.5 % ) reached the primary endpoint , compared with 178 patients ( 22.1 % ) in the BMS group ( hazard ratio : 0.76 ; 95 % confidence interval : 0.61 to 0.95 ; p = 0.011 ) as a result of lower MI ( 2.9 % vs. 8.1 % ; p < 0.001 ) and TVR rates ( 5.9 % vs. 10.7 % ; p = 0.001 ) in the ZES group .
-RESULTS	Definite or probable stent thrombosis was also significantly reduced in ZES recipients ( 2.0 % vs. 4.1 % ; p = 0.019 ) .
-CONCLUSIONS	Compared with BMS , DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics , combined with an abbreviated , tailored DAPT regimen , resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation .
-CONCLUSIONS	( Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ ZEUS ] Study ; NCT01385319 ) .
-
-###25122601
-OBJECTIVE	The purpose of the present study was to assess the influence of electrode insertion length on cochlear implant ( CI ) performance .
-METHODS	Prospective randomized allocation of CI patients to receive either a standard ( 26.4 mm ) - or medium ( 20.9 mm ) - length electrode array .
-METHODS	The processing strategy and electrode insertion number were held constant .
-METHODS	The postoperative testing audiologist was blinded to the map details and array .
-METHODS	Tertiary referral center .
-METHODS	Thirteen adult CI candidates randomized to receive the standard - ( n = 7 ) or medium-length ( n = 6 ) electrode array .
-METHODS	Unilateral CI using standard - or medium-length array from the same implant system .
-METHODS	Speech perception was assessed with HINT sentences in quiet and steady-state noise ( SNR , +10 ) and CNC words in quiet at defined intervals .
-METHODS	Quality of life was assessed using the Hearing Device Satisfaction Survey and the Abbreviated Profile of Hearing Aid Benefit ( APHAB ) .
-METHODS	Music perception was assessed using the Musical Sounds In Cochlear implants ( MuSIC ) test .
-METHODS	Postoperative electrode insertion angle was assessed using reconstructed computed tomographic images .
-RESULTS	Interim analysis necessitated discontinuation of subject enrollment by the institutional review board .
-RESULTS	There was a trend ( p = 0.07 ) for improved speech perception performance among standard array patients .
-RESULTS	This difference was significant when the standard array group was increased retrospectively .
-RESULTS	Quality of life and music perception differences were not apparent between groups .
-CONCLUSIONS	Longer electrode insertions ( and greater insertion angles ) appear to offer better speech perception performance in the early postactivation period when using the same implant system .
-
-###26521577
-OBJECTIVE	To compare the differences in the clinical efficacy on neurogenic bladder after spinal cord injury ( SCD between the matrix needling technique combined with rehabilitation training and rehabilitation training in the patients .
-METHODS	Sixty patients of SCI neurogenic bladder were randomized into an observation group ( 29 cases ) and a control group ( 31 cases ) .
-METHODS	In the control group , the conventional rehabilitation therapy , the intermittent catheterization and bladder function training were adopted , once every day , for 4 weeks totally .
-METHODS	In the observation group , on the basic treatment of the rehabilitation as the control group , the matrix needling technique and acupuncture at sanyin points were applied .
-METHODS	The treatment of 8 days made one session , at the interval of 2 days , continuously for 3 sessions , meaning 4 weeks totally .
-METHODS	The bladder function score , residual urine volume and bladder capacity were compared before and after treatment in the two groups .
-RESULTS	The bladder function score was reduced after treatment as compared with that before treatment in either group ( both P < 0.05 ) .
-RESULTS	The score in the observation group was lower than that in the control group after treatment ( P < 0.05 ) .
-RESULTS	No matter which spinal segment was injured , the residual urine volume after treatment was reduced as compared with that before treatment and the bladder capacity was increased ( P < 0.05 ) .
-RESULTS	The residual urine volume in the observation group was less than that in the control group after treatment and the bladder capacity was more increased ( P < 0.05 ) .
-CONCLUSIONS	The conventional rehabilitation program in combination with the matrix needling technique and acupuncture at sanyin points achieve the significant efficacy on SCI neurogenic bladder .
-
-###25147155
-OBJECTIVE	Numerous uremic solutes are derived from the action of colon microbes .
-OBJECTIVE	Two such solutes , indoxyl sulfate and p-cresol sulfate , have been associated with adverse outcomes in renal failure .
-OBJECTIVE	This study tested whether increasing dietary fiber in the form of resistant starch would lower the plasma levels of these solutes in patients on hemodialysis .
-METHODS	Fifty-six patients on maintenance hemodialysis were randomly assigned to receive supplements containing resistant starch ( n = 28 ) or control starch ( n = 28 ) daily for 6 weeks in a study conducted between October 2010 and May 2013 .
-METHODS	Of these , 40 patients ( 20 in each group ) completed the study and were included in the final analysis .
-METHODS	Plasma indoxyl sulfate and p-cresol sulfate levels were measured at baseline and week 6 .
-RESULTS	Increasing dietary fiber for 6 weeks significantly reduced the unbound , free plasma level of indoxyl sulfate ( median -29 % [ 25th percentile , 75th percentile , -56 , -12 ] for fiber versus -0.4 % [ -20 , 34 ] for control , P = 0.02 ) .
-RESULTS	The reduction in free plasma levels of indoxyl sulfate was accompanied by a reduction in free plasma levels of p-cresol sulfate ( r = 0.81 , P < 0.001 ) .
-RESULTS	However , the reduction of p-cresol sulfate levels was of lesser magnitude and did not achieve significance ( median -28 % [ -46 , 5 ] for fiber versus 4 % [ -28 , 36 ] for control , P = 0.05 ) .
-CONCLUSIONS	Increasing dietary fiber in hemodialysis patients may reduce the plasma levels of the colon-derived solutes indoxyl sulfate and possibly p-cresol sulfate without the need to intensify dialysis treatments .
-CONCLUSIONS	Further studies are required to determine whether such reduction provides clinical benefits .
-
-###25872612
-BACKGROUND	Falls are a major public health concern with at least one third of people aged 65 years and over falling at least once per year , and half of these will fall repeatedly , which can lead to injury , pain , loss of function and independence , reduced quality of life and even death .
-BACKGROUND	Although the causes of falls are varied and complex , the age-related loss in muscle power has emerged as a useful predictor of disability and falls in older people .
-BACKGROUND	In this population , the requirements to produce explosive and rapid movements often occurs whilst simultaneously performing other attention-demanding cognitive or motor tasks , such as walking while talking or carrying an object .
-BACKGROUND	The primary aim of this study is to determine whether dual-task functional power training ( DT-FPT ) can reduce the rate of falls in community-dwelling older people .
-METHODS	The study design is an 18-month cluster randomised controlled trial in which 280 adults aged 65 years residing in retirement villages , who are at increased risk of falling , will be randomly allocated to : 1 ) an exercise programme involving DT-FPT , or 2 ) a usual care control group .
-METHODS	The intervention is divided into 3 distinct phases : 6 months of supervised DT-FPT , a 6-month ` step down ' maintenance programme , and a 6-month follow-up .
-METHODS	The primary outcome will be the number of falls after 6 , 12 and 18 months .
-METHODS	Secondary outcomes will include : lower extremity muscle power and strength , grip strength , functional assessments of gait , reaction time and dynamic balance under single - and dual-task conditions , activities of daily living , quality of life , cognitive function and falls-related self-efficacy .
-METHODS	We will also evaluate the cost-effectiveness of the programme for preventing falls .
-CONCLUSIONS	The study offers a novel approach that may guide the development and implementation of future community-based falls prevention programmes that specifically focus on optimising muscle power and dual-task performance to reduce falls risk under ` real life ' conditions in older adults .
-CONCLUSIONS	In addition , the ` step down ' programme will provide new information about the efficacy of a less intensive maintenance programme for reducing the risk of falls over an extended period .
-BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12613001161718 .
-BACKGROUND	Date registered 23 October 2013 .
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-###25138127
-OBJECTIVE	To evaluate the effects of a non-pharmacologic electro-acupuncture method at different acupoints on labor pain management .
-METHODS	Nulliparous women under the maternity care of the Department of Obstetrics and Gynecology of Sir Run Run Shaw Hospital were recruited and allocated into two experimental groups ( EX-B2 group and SP6 group ) and one control group , each with 60 eligible participants .
-METHODS	Visual analog scale ( VAS ) was used to assess the pain during active phase of labor before and 30 , 60 , 120 min after intervention .
-METHODS	The duration of active phase , the duration of second stage of labor , the duration of third stage of labor , use of oxytocin , neonatal birth weight , neonatal Apgar score at 1 and 5 min were considered as secondary outcomes of this study .
-RESULTS	After 30 min intervention , the mean VAS scores of both EX-B2 group and SP6 group were significantly decreased compared with the control group ( P < 0.01 ) ; however , no significant difference was observed between the two experimental groups ( P > 0.05 ) .
-RESULTS	After 60 and 120 min intervention , the mean VAS scores of EX-B2 group were significantly lower than SP-6 group ( P < 0.05 ) .
-RESULTS	Both EX-B2 group and SP6 group had significant lower VAS scores after interventions and shorter time used in active phase of labor than the control group ( P < 0.05 ) .
-CONCLUSIONS	The study revealed that the application of electro-acupuncture at EX-B2 and SP6 acupoints could be used as a non-pharmacologic method to reduce labor pain and shorten the duration of active phase of labor .
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-###24428334
-BACKGROUND	Models of addictive behaviors postulate that implicit alcohol-related memory associations and biased interpretation processes contribute to the development and maintenance of alcohol misuse and abuse .
-BACKGROUND	The present study examined whether alcohol-dependent patients ( AP ) show an alcohol-related interpretation bias .
-BACKGROUND	Second , the relationship between the interpretation bias and levels of harmful drinking was investigated .
-METHODS	The sample included 125 clinically diagnosed AP and 69 clinically diagnosed control patients ( CP ) who had either a mood or an anxiety disorder .
-METHODS	Participants completed a booklet containing 12 open-ended ambiguous scenarios .
-METHODS	Seven scenarios were alcohol-relevant , and 5 were emotionally relevant , that is , panic - or depression-relevant .
-METHODS	Participants were asked to read each scenario and to generate a continuation .
-METHODS	In addition , the Alcohol Use Disorder Identification Test ( AUDIT ) and Beck Depression Inventory were administered .
-RESULTS	Logistic multivariate multilevel analyses revealed that AP ' probability of generating an alcohol-related continuation on all 3 scenario types was higher than that of CP .
-RESULTS	Moreover , alcohol-related interpretation biases were positively associated with levels of harmful drinking ( i.e. , AUDIT scores ) .
-CONCLUSIONS	These findings are the first to show that AP show an alcohol-related interpretation bias , which generalizes to other ambiguous emotionally relevant contexts , and therefore advance our understanding of the role of implicit biased alcohol-related memory associations and interpretation processes .
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-###24811237
-BACKGROUND	Previous research has indicated positive effects of early developmental intervention ( EDI ) on the development of children in developing countries .
-BACKGROUND	Few studies , however , have examined longitudinally when differential treatment effects may be observed and whether differential outcomes are associated with exposure to different risk factors and country of implementation .
-BACKGROUND	Also , birth asphyxia as a risk condition has not been well studied .
-BACKGROUND	To address these limitations , we conducted a randomized controlled trial to test the hypothesis that there will be differential developmental trajectories favoring those who receive EDI versus a health education intervention in children in rural areas of India , Pakistan , and Zambia .
-METHODS	Children with and without birth asphyxia were randomized to EDI or control intervention , which was implemented by parents who received training in biweekly home visits initiated before child age 1 month and continuing until 36 months .
-METHODS	Development was assessed in 376 children at ages 12 , 24 , and 36 months using the Bayley Scales of Infant Development and Ages & Stages Questionnaire administered by evaluators blind to intervention assignment and risk condition .
-RESULTS	Longitudinal mixed model analysis indicated that EDI resulted in better development over 36 months in cognitive abilities , regardless of risk condition , maternal resources , child gender , or country .
-RESULTS	Psychomotor development and parent-reported general development showed similar trends as for cognitive abilities , but were not statistically different between intervention conditions .
-RESULTS	Developmental differences were observed first at 36 months of age .
-CONCLUSIONS	Early developmental intervention has promise for improving development in children across developing countries when exposed to various risk conditions .
-CONCLUSIONS	EDI should be one prominent approach used to begin to address long-term outcomes and intergenerational transmission of poverty .
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-###25102706
-BACKGROUND	The aim of this randomized controlled study was to compare the postoperative analgesic efficacy of intraperitoneal bupivacaine versus levobupivacaine in patients undergoing laparoscopic cholecystectomy .
-METHODS	We randomly divided 90 patients undergoing elective laparoscopic cholecystectomy into 3 groups .
-METHODS	A dose of 0.125 % bupivacaine ( Group B ) 80 ml or 0.125 % levobupivacaine ( Group L ) 80 ml or 0.09 % NaCl ( Group P ) 80 ml was instilled intraperitoneally at the end of the procedure , before removal of the trocars .
-METHODS	All patients had a standard anesthetic .
-METHODS	Tramadol was administered intravenously via a patient controlled analgesia pump as a rescue analgesic in all patients .
-METHODS	Postoperative pain scores were assessed at 30 minutes , 1 , 2 , 4 , 6 , 12 and 24 hours after surgery by using a visual analog scale .
-METHODS	The primary end point of this study was to compare tramadol consumption of the three groups at the postoperative 24 h. Total tramadol consumption , first analgesic requirement time and adverse effects were recorded .
-RESULTS	Group B experienced significantly less pain ( P < 0.01 ) than the placebo group at 6 h , 12 h and 24 h postoperatively during rest .
-RESULTS	Group L registered significantly lower visual analog scale scores ( p < 0.01 ) than the placebo group at 12 h during rest .
-RESULTS	During movement , visual analog scale pain scores were lower in group B than Group P ( P < 0.01 ) .
-RESULTS	Additionally , total tramadol consumption was significantly lower in Group B than the other groups .
-RESULTS	First analgesic requirement time was shorter in the placebo group compared with group B and group L ( P < 0.05 ) .
-RESULTS	There was no significant difference between the groups with respect to right shoulder pain , total nausea and vomiting .
-CONCLUSIONS	Intraperitoneal instillation of bupivacaine 0.125 % 80 ml ( 100 mg ) is more effective than levobupivacaine 0.125 % 80 ml ( 100 mg ) in reducing the postoperative pain after laparoscopic cholecystectomy .
-
-###24613550
-OBJECTIVE	To evaluate the diagnostic performance of three-dimensional ( 3D ) MR maximum intensity projection ( MIP ) in the assessment of synovitis of the hand and wrist in rheumatoid arthritis ( RA ) compared to 3D contrast-enhanced magnetic resonance imaging ( CE-MRI ) .
-METHODS	Twenty-five patients with RA underwent MR examinations .
-METHODS	3D MR MIP images were derived from the enhanced images .
-METHODS	MR images were reviewed by two radiologists for the presence and location of synovitis of the hand and wrist .
-METHODS	The diagnostic sensitivity , specificity and accuracy of 3D MIP were , respectively , calculated with the reference standard 3D CE-MRI .
-RESULTS	In all subjects , 3D MIP images yielded directly and clearly the presence and location of synovitis with just one image .
-RESULTS	Synovitis demonstrated high signal intensity on MIP images .
-RESULTS	The k-values for the detection of articular synovitis indicated excellent interobserver agreements using 3D MIP images ( k = 0.87 ) and CE-MR images ( k = 0.91 ) , respectively .
-RESULTS	3D MIP demonstrated a sensitivity , specificity and accuracy of 91.07 % , 98.57 % and 96.0 % , respectively , for the detection of synonitis .
-CONCLUSIONS	3D MIP can provide a whole overview of lesion locations and a reliable diagnostic performance in the assessment of articular synovitis of the hand and wrist in patients with RA , which has potential value of clinical practice .
-
-###26406150
-BACKGROUND	Cabozantinib is an oral , small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor ( VEGFR ) as well as MET and AXL , each of which has been implicated in the pathobiology of metastatic renal-cell carcinoma or in the development of resistance to antiangiogenic drugs .
-BACKGROUND	This randomized , open-label , phase 3 trial evaluated the efficacy of cabozantinib , as compared with everolimus , in patients with renal-cell carcinoma that had progressed after VEGFR-targeted therapy .
-METHODS	We randomly assigned 658 patients to receive cabozantinib at a dose of 60 mg daily or everolimus at a dose of 10 mg daily .
-METHODS	The primary end point was progression-free survival .
-METHODS	Secondary efficacy end points were overall survival and objective response rate .
-RESULTS	Median progression-free survival was 7.4 months with cabozantinib and 3.8 months with everolimus .
-RESULTS	The rate of progression or death was 42 % lower with cabozantinib than with everolimus ( hazard ratio , 0.58 ; 95 % confidence interval [ CI ] 0.45 to 0.75 ; P < 0.001 ) .
-RESULTS	The objective response rate was 21 % with cabozantinib and 5 % with everolimus ( P < 0.001 ) .
-RESULTS	A planned interim analysis showed that overall survival was longer with cabozantinib than with everolimus ( hazard ratio for death , 0.67 ; 95 % CI , 0.51 to 0.89 ; P = 0.005 ) but did not cross the significance boundary for the interim analysis .
-RESULTS	Adverse events were managed with dose reductions ; doses were reduced in 60 % of the patients who received cabozantinib and in 25 % of those who received everolimus .
-RESULTS	Discontinuation of study treatment owing to adverse events occurred in 9 % of the patients who received cabozantinib and in 10 % of those who received everolimus .
-CONCLUSIONS	Progression-free survival was longer with cabozantinib than with everolimus among patients with renal-cell carcinoma that had progressed after VEGFR-targeted therapy .
-CONCLUSIONS	( Funded by Exelixis ; METEOR ClinicalTrials.gov number , NCT01865747 . )
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-###24529670
-BACKGROUND	Low-dose ketamine infusion ( blood concentration around 100 ng/mL ) during surgery reduces the incidence of postoperative shivering after remifentanil-based anesthesia .
-BACKGROUND	We hypothesized that perioperative infusion of very low-dose ketamine ( blood concentration around 40 ng/mL ) during remifentanil-based anesthesia may also prevent the development of remifentanil-induced shivering during the 2-hour period after the end of anesthesia .
-METHODS	Fifty female patients scheduled to undergo laparoscopic cystectomy or oophorectomy were assigned to one of two groups : ( 1 ) ketamine group , in which the patients received ketamine infusion ( 0.1 mg/kg/hour ) from induction of anesthesia to emergence from anesthesia ; and ( 2 ) control group , in which the patients received saline infusion from induction up till emergence from anesthesia .
-METHODS	Anesthesia was induced and maintained by target-controlled infusion of propofol ( estimated blood concentration : 2-4 g/mL ) and infusion of remifentanil , at 0.2-0 .3 g/kg/minute .
-METHODS	Patients were observed for shivering from the end of anesthesia to 120 minutes after anesthesia .
-METHODS	The time point at which the patient began to shiver was recorded and assigned to one of four time periods : at emergence , from emergence to 30 minutes after anesthesia , from 30 minutes to 60 minutes after anesthesia , and > 60 minutes after anesthesia .
-RESULTS	During the 120-minute observation period , the number of patients who shivered was higher in the ketamine group than the in control group ( 18 vs. 8 , ketamine group vs. control group , p = 0.01 ) .
-RESULTS	The time period during which patients began to shiver was different between the two groups ( 1 patient , 4 patients , and 13 patients vs. 3 patients , 2 patients , and 3 patients at emergence , from emergence to 30 minutes , and from 30 minutes to 60 minutes after anesthesia , respectively ; ketamine group vs. control group , p = 0.007 ) .
-CONCLUSIONS	Intraoperative infusion of very low-dose ketamine during remifentanil-based anesthesia may increase the incidence of postoperative shivering .
-
-###25197826
-OBJECTIVE	We assessed whether a brief alcohol intervention would lead to reduced alcohol use and sexually transmitted infection ( STI ) / HIV incidence and related sexual risk behaviors among moderate drinking female sex workers .
-METHODS	A randomized controlled intervention trial was conducted with 818 female sex workers affiliated with the AIDS , Population , Health , and Integrated Assistance II project in Mombasa , Kenya .
-METHODS	Eligible women were hazardous or harmful drinkers who scored between 7 and 19 ( full range , 1-40 ) on the Alcohol Use Disorders Identification Test .
-METHODS	Intervention participants received 6 counseling sessions approximately monthly .
-METHODS	The equal-attention control group received 6 nutrition sessions .
-METHODS	Participants were followed for 6 and 12 months after the intervention , with at least 86 % retention at both time points .
-METHODS	We used general linear models in intention-to-treat analyses , adjusting for recruitment setting and HIV status at enrollment .
-RESULTS	There was a statistically significant reduction in alcohol use and binge drinking at 6 and 12 months , with intervention participants reporting less than one third of the odds of higher levels of drinking than the control group .
-RESULTS	The intervention did not impact laboratory-confirmed STI/HIV incidence , self-reported condom use , or sexual violence from nonpaying partners .
-RESULTS	However , the odds of reporting sexual violence from clients was significantly lower among intervention than control participants at both 6 and 12 months .
-CONCLUSIONS	We found that a brief alcohol intervention can reduce self-reported alcohol consumption among a nondependent and non-treatment-seeking population most at risk for HIV .
-CONCLUSIONS	More attention is needed to understand the pathway from drinking to sexual behavior and STI/HIV acquisition .
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-###25842223
-BACKGROUND	WHO recommends referral to hospital for possible serious bacterial infection in young infants aged 0-59 days .
-BACKGROUND	We aimed to assess whether oral amoxicillin treatment for fast breathing , in the absence of other signs , is as efficacious as the combination of injectable procaine benzylpenicillin-gentamicin .
-METHODS	In a randomised , open-label , equivalence trial at five sites in DR Congo , Kenya , and Nigeria , community health workers followed up all births in the community , identified unwell young infants , and referred them to study nurses .
-METHODS	We randomly assigned infants with fast breathing as a single sign of illness or possible serious bacterial infection , whose parents did not accept referral to hospital , to receive either injectable procaine benzylpenicillin-gentamicin once per day or oral amoxicillin treatment twice per day for 7 days .
-METHODS	A person who was off-site generated randomisation lists using computer software .
-METHODS	Trained health professionals gave injections , but outcome assessors were masked to group allocations .
-METHODS	The primary outcome was treatment failure by day 8 after enrolment , defined as clinical deterioration , development of a serious adverse event including death , persistence of fast breathing on day 4 , or recurrence up to day 8 .
-METHODS	The primary analysis was per protocol and we used a prespecified similarity margin of 5 % to assess equivalence between regimens .
-METHODS	This study is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12610000286044 .
-RESULTS	From April 4 , 2011 , to March 29 , 2013 , we enrolled 2333 infants aged 0-59 days with fast breathing as the only sign of possible serious bacterial infection at the five study sites .
-RESULTS	We assigned 1170 infants to receive injectable procaine benzylpenicillin-gentamicin and 1163 infants to receive oral amoxicillin .
-RESULTS	In the per-protocol analysis , from which 137 infants were excluded , we included 1061 ( 91 % ) infants who fulfilled predefined criteria of adherence to treatment and adequate follow-up in the injectable procaine benzylpenicillin-gentamicin group and 1145 ( 98 % ) infants in the oral amoxicillin group .
-RESULTS	In the procaine benzylpenicillin-gentamicin group , 234 infants ( 22 % ) failed treatment , compared with 221 ( 19 % ) infants in the oral amoxicillin group ( risk difference -26 % , 95 % CI -60 to 08 ) .
-RESULTS	Four infants died within 15 days of follow-up in each group .
-RESULTS	We detected no drug-related serious adverse events .
-CONCLUSIONS	Young infants with fast breathing alone can be effectively treated with oral amoxicillin on an outpatient basis when referral to a hospital is not possible .
-BACKGROUND	Bill & Melinda Gates Foundation grant to WHO .
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-###25679310
-BACKGROUND	To analyze the impact of weight loss before and during chemoradiation on survival outcomes in patients with locally advanced head and neck cancer .
-METHODS	From 07/1994 -07 / 2000 a total of 224 patients with squamous cell carcinoma of the head and neck were randomized to either hyperfractionated radiation therapy alone or the same radiation therapy combined with two cycles of concomitant cisplatin .
-METHODS	The primary endpoint was time to any treatment failure ( TTF ) ; secondary endpoints were locoregional recurrence-free survival ( LRRFS ) , distant metastasis-free survival ( DMFS ) and overall survival ( OS ) .
-METHODS	Patient weight was measured 6 months before treatment , at treatment start and treatment end .
-RESULTS	The proportion of patients with > 5 % weight loss was 32 % before , and 51 % during treatment , and the proportion of patients with > 10 % weight loss was 12 % before , and 17 % during treatment .
-RESULTS	After a median follow-up of 9.5 years ( range , 0.1 - 15.4 years ) weight loss before treatment was associated with decreased TTF , LRRFS , DMFS , cancer specific survival and OS in a multivariable analysis .
-RESULTS	However , weight loss during treatment was not associated with survival outcomes .
-CONCLUSIONS	Weight loss before and during chemoradiation was commonly observed .
-CONCLUSIONS	Weight loss before but not during treatment was associated with worse survival .
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-###25117433
-OBJECTIVE	To compare the effects of sprint training with or without ball carry on the sprint performance of elite rugby league players .
-METHODS	Twenty-four elite rugby league players were divided into a ball-carry group ( BC ; n = 12 ) and a no-ball-carry group ( NBC ; n = 12 ) .
-METHODS	The players of the BC group were required to catch and carry the ball under 1 arm during each sprint , whereas the NBC group performed sprints without carrying a ball .
-METHODS	The 8-wk training intervention took place during the precompetitive phase of the season and consisted of 2 sessions/wk .
-METHODS	Sprint performance was measured before and after the training intervention with 40-m linear sprints performed under 2 conditions : with and without ball carry .
-METHODS	Split times of 10 , 20 , and 40 m were recorded for further analysis .
-METHODS	A 3-way ( group time condition ) factorial ANOVA was performed to compare changes in sprint performance with and without the ball , before and after the training intervention for both BC and NBC training groups Results : The BC and NBC groups experienced similar improvements in 10 - , 20 - , and 40-m sprint times and accelerations , regardless of the condition under which the sprint tests were performed ( P = .19 ) .
-CONCLUSIONS	Sprint training while carrying a rugby ball is as effective as sprint training without carrying a rugby ball for improving the sprint performance of elite rugby league players .
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-###24874347
-OBJECTIVE	ADHD affects between 2 % and 8 % of college students and is associated with broad functional impairment .
-OBJECTIVE	No prior randomized controlled trials with this population have been published .
-OBJECTIVE	The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy ( DBT ) group skills training adapted for college students with ADHD .
-METHODS	Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase .
-METHODS	ADHD symptoms , executive functioning ( EF ) , and related outcomes were assessed at baseline , post-treatment , and 3-month follow-up .
-RESULTS	Participants receiving DBT group skills training showed greater treatment response rates ( 59-65 % vs. 19-25 % ) and clinical recovery rates ( 53-59 % vs. 6-13 % ) on ADHD symptoms and EF , and greater improvements in quality of life .
-CONCLUSIONS	DBT group skills training may be efficacious , acceptable , and feasible for treating ADHD among college students .
-CONCLUSIONS	A larger randomized trial is needed for further evaluation .
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-###24622044
-BACKGROUND	The Respiratory Infections in Andean Peruvian Children ( RESPIRA-PERU ) study enrolled children who participated in a community-cluster randomized trial of improved stoves , solar water disinfection , and kitchen sinks ( IHIP trial ) and children from additional Andean households .
-BACKGROUND	We quantified the burden of influenza-associated acute respiratory illness ( ARI ) in this household-based cohort .
-METHODS	From May 2009 to September 2011 , we conducted active weekly ARI surveillance in 892 children age < 3 years , of whom 272 ( 30.5 % ) had participated in the IHIP trial .
-METHODS	We collected nasal swabs during ARI , tested for influenza and other respiratory viruses by RT-PCR , and determined influenza incidence and risk factors using mixed-effects regression models .
-RESULTS	The overall incidence of influenza-associated ARI was 36.6 / 100 child-years ; incidence of influenza A , B , and C was 20.5 , 8.7 , and 5.2 / 100 child-years , respectively .
-RESULTS	Influenza C was associated with fewer days of subjective fever ( median 1 vs. 2 ) and malaise ( median 0 vs. 2 ) compared to influenza A. Non-influenza ARI also resulted in fewer days of fever and malaise , and fewer healthcare visits than influenza A-associated ARI .
-RESULTS	Influenza incidence varied by calendar year ( 80 % occurred in the 2010 season ) and IHIP trial participation .
-RESULTS	Among households that participated in the IHIP trial , influenza-associated ARI incidence was significantly lower in intervention than in control households ( RR 0.40 , 95 % CI : 0.20-0 .82 ) .
-CONCLUSIONS	Influenza burden is high among Andean children .
-CONCLUSIONS	ARI associated with influenza A and B had longer symptom duration and higher healthcare utilization than influenza C-associated ARI or non-influenza ARI .
-CONCLUSIONS	Environmental community interventions may reduce influenza morbidity .
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-###25487431
-BACKGROUND	Traffic-related air pollution may contribute to cardiovascular morbidity .
-BACKGROUND	In urban areas , exposures during physical activity are of interest owing to increased breathing rates and close proximity to vehicle emissions .
-METHODS	We conducted a cross-over study among 53 healthy non-smoking women in Montreal , Canada during the summer of 2013 .
-METHODS	Women were exposed to traffic pollutants for 2-hours on three separate occasions during cycling on high and low-traffic routes as well as indoors .
-METHODS	Personal air pollution exposures ( PM ( 2.5 ) , ultrafine particles ( UFP ) , black carbon , NO , and O ) were evaluated along each route and linear mixed-effects models with random subject intercepts were used to estimate the impact of air pollutants on acute changes in blood pressure , heart rate variability , and micro-vascular function in the hours immediately following exposure .
-METHODS	Single and multi-pollutant models were examined and potential effect modification by mean regional air pollution concentrations ( PM ( 2.5 ) , NO , and O ) was explored for the 24-hour and 5-day periods preceding exposure .
-RESULTS	In total , 143 exposure routes were completed .
-RESULTS	Each interquartile increase ( 10,850 / cm ) in UFP exposure was associated with a 4.91 % ( 95 % CI : -9.31 , -0.512 ) decrease in reactive hyperemia index ( a measure of micro-vascular function ) and each 24 ppb increase in O exposure corresponded to a 2.49 % ( 95 % CI : 0.141 , 4.84 ) increase in systolic blood pressure and a 3.26 % ( 95 % CI : 0.0117 , 6.51 ) increase in diastolic blood pressure 3-hours after exposure .
-RESULTS	Personal exposure to PM ( 2.5 ) was associated with decreases in HRV measures reflecting parasympathetic modulation of the heart and regional PM ( 2.5 ) concentrations modified these relationships ( p < 0.05 ) .
-RESULTS	In particular , stronger inverse associations were observed when regional PM ( 2.5 ) was higher on the days prior to the study period .
-RESULTS	Regional PM ( 2.5 ) also modified the impact of personal O on the standard deviation of normal to normal intervals ( SDNN ) ( p < 0.05 ) : a significant inverse relationship was observed when regional PM ( 2.5 ) was low prior to study periods and a significant positive relationship was observed when regional PM ( 2.5 ) was high .
-CONCLUSIONS	Exposure to traffic pollution may contribute to acute changes in blood pressure , autonomic and micro-vascular function in women .
-CONCLUSIONS	Regional air pollution concentrations may modify the impact of these exposures on autonomic function .
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-###25236883
-BACKGROUND	This trial tested the effects of multidisciplinary group clinic appointments on the primary outcome of time to first heart failure ( HF ) rehospitalization or death .
-RESULTS	HF patients ( n = 198 ) were randomly assigned to standard care or standard care plus multidisciplinary group clinics .
-RESULTS	The group intervention consisted of 4 weekly clinic appointments and 1 booster clinic at month 6 , where multidisciplinary professionals engaged patients in HF self-management skills .
-RESULTS	Data were collected prospectively for 12 months beginning after completion of the first 4 group clinic appointments ( 2 months post randomization ) .
-RESULTS	The intervention was associated with greater adherence to recommended vasodilators ( P = 0.04 ) .
-RESULTS	The primary outcome ( first HF-related hospitalization or death ) was experienced by 22 ( 24 % ) in the intervention group and 30 ( 28 % ) in standard care .
-RESULTS	The total HF-related hospitalizations , including repeat hospitalizations after the first time , were 28 in the intervention group and 45 among those receiving standard care .
-RESULTS	The effects of treatment on rehospitalization varied significantly over time .
-RESULTS	From 2 to 7 months post randomization , there was a significantly longer hospitalization-free time in the intervention group ( Cox proportional hazard ratio = 0.45 ( 95 % confidence interval , 0.21-0 .98 ; P = 0.04 ) .
-RESULTS	No significant difference between groups was found from month 8 to 12 ( hazard ratio = 1.7 ; 95 % confidence interval , 0.7-4 .1 ) .
-CONCLUSIONS	Multidisciplinary group clinic appointments were associated with greater adherence to selected HF medications and longer hospitalization-free survival during the time that the intervention was underway .
-CONCLUSIONS	Larger studies will be needed to confirm the benefits seen in this trial and identify methods to sustain these benefits .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00439842 .
-
-###24788102
-OBJECTIVE	Racotumomab-alum is an anti-idiotype vaccine targeting the NeuGcGM3 tumor-associated ganglioside .
-OBJECTIVE	This clinical trial was conducted to provide a preliminary estimate of efficacy and safety of racotumomab as switch maintenance for patients with advanced non-small cell lung cancer ( NSCLC ) .
-METHODS	Patients with stage IIIb/IV NSCLC who have at least stable disease after first-line chemotherapy were randomized 1:1 to racotumomab-alum ( 5 immunizations every 2 weeks and re-immunizations every 4 weeks ) or placebo .
-METHODS	Treatment was administered beyond progressive disease , until severe performance status worsening or toxicity .
-METHODS	At progression , only five patients per group received further anticancer therapy .
-METHODS	The primary endpoint was overall survival ( OS ) .
-RESULTS	One-hundred and seventy-six patients were randomized to racotumomab-alum ( n = 87 ) and placebo ( n = 89 ) .
-RESULTS	Median OS was 8.23 and 6.80 months , respectively [ HR , 0.63 ; 95 % confidence interval ( CI ) , 0.46-0 .87 ; P = 0.004 ] .
-RESULTS	Median progression-free survival ( PFS ) in vaccinated patients was 5.33 versus 3.90 months for placebo ( HR , 0.73 ; 95 % CI 0.53-0 .99 ; P = 0.039 ) .
-RESULTS	The most common adverse events in the racotumomab-alum arm were burning and pain at the injection site , bone pain , and asthenia .
-RESULTS	A high antibody response of IgM and IgG isotype against the NeuGcGM3 ganglioside was obtained .
-RESULTS	Hyperimmune sera were able to specifically recognize and kill the NeuGcGM3-expressing L1210 cell line .
-RESULTS	Patients who developed anti-NeuGcGM3 antibodies capable to bind and kill 30 % L1210 cells showed longer median survival times .
-CONCLUSIONS	Switch maintenance with racotumomab-alum is an effective and a well-tolerated treatment option for patients with advanced NSCLC .
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-###26059012
-BACKGROUND	Patients with kidney disease have disordered bone and mineral metabolism , including elevated serum concentrations of fibroblast growth factor-23 ( FGF23 ) .
-BACKGROUND	These elevated concentrations are associated with cardiovascular and all-cause mortality .
-BACKGROUND	The objective was to determine the effects of the calcimimetic cinacalcet ( versus placebo ) on reducing serum FGF23 and whether changes in FGF23 are associated with death and cardiovascular events .
-RESULTS	This was a secondary analysis of a randomized clinical trial comparing cinacalcet to placebo in addition to conventional therapy ( phosphate binders/vitamin D ) in patients receiving hemodialysis with secondary hyperparathyroidism ( intact parathyroid hormone 300 pg/mL ) .
-RESULTS	The primary study end point was time to death or a first nonfatal cardiovascular event ( myocardial infarction , hospitalization for angina , heart failure , or a peripheral vascular event ) .
-RESULTS	This analysis included 2985 patients ( 77 % of randomized ) with serum samples at baseline and 2602 patients ( 67 % ) with samples at both baseline and week 20 .
-RESULTS	The results demonstrated that a significantly larger proportion of patients randomized to cinacalcet had 30 % ( 68 % versus 28 % ) reductions in FGF23 .
-RESULTS	Among patients randomized to cinacalcet , a 30 % reduction in FGF23 between baseline and week 20 was associated with a nominally significant reduction in the primary composite end point ( relative hazard , 0.82 ; 95 % confidence interval , 0.69-0 .98 ) , cardiovascular mortality ( relative hazard , 0.66 ; 95 % confidence interval , 0.50-0 .87 ) , sudden cardiac death ( relative hazard , 0.57 ; 95 % confidence interval , 0.37-0 .86 ) , and heart failure ( relative hazard , 0.69 ; 95 % confidence interval , 0.48-0 .99 ) .
-CONCLUSIONS	Treatment with cinacalcet significantly lowers serum FGF23 .
-CONCLUSIONS	Treatment-induced reductions in serum FGF23 are associated with lower rates of cardiovascular death and major cardiovascular events .
-BACKGROUND	URL : http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00345839 .
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-###24568978
-OBJECTIVE	To determine whether demographic or clinical factors are associated with the outcome of office-based nasolacrimal duct probing for the treatment of congenital nasolacrimal duct obstruction ( NLDO ) .
-METHODS	In two multicenter prospective studies , 384 eyes of 304 children aged 6 to < 15 months with NLDO underwent a nasolacrimal duct probing performed in the office using topical anesthesia .
-METHODS	Treatment success , defined as no clinical signs of NLDO ( epiphora , increased tear lake , or mucous discharge ) and no reoperation , was assessed 1 month after probing in one study and 6 months after probing in the other study .
-METHODS	Data from both studies were pooled to evaluate associations between baseline characteristics and treatment success .
-RESULTS	Office probing was successful in 75 % of eyes overall ( 95 % CI , 70 % -80 % ) .
-RESULTS	The procedure was less successful in eyes of children with bilateral NLDO compared with unilateral NLDO ( 63 % vs 80 % ; relative risk = 0.78 [ 95 % CI , 0.66-0 .92 ] ) and in eyes that had 2 or 3 clinical signs of NLDO compared with one ( 71 % vs 83 % ; relative risk = 0.88 [ 95 % CI , 0.81-0 .96 ] ) .
-RESULTS	Treatment success did not appear to be related to age , specific clinical signs of NLDO , prior treatment , or research study .
-CONCLUSIONS	Performing nasolacrimal duct probing in the office successfully treats NLDO in the majority of cases in children aged 6 to < 15 months .
-CONCLUSIONS	The success rate is lower with bilateral disease or when more than one clinical sign of NLDO is present .
-
-###24983742
-OBJECTIVE	Allergic rhinitis ( AR ) is caused by an IgE-mediated inflammatory reaction consequent to the exposure to causal allergen .
-OBJECTIVE	Resveratrol is a natural non-flavonoid polyphenol , exerting anti-inflammatory activity ; - glucan is a polysaccharide with immuno-modulatory properties .
-OBJECTIVE	Thus , this study aimed to investigate whether these combined compounds are able of relieving nasal symptoms in children with AR due to pollen allergy .
-METHODS	The present study was conducted as placebo-controlled , double-blinded , and randomized .
-METHODS	Globally , 68 children ( 36 males ; mean age 7.9 years ) were treated with resveratrol plus - glucan or placebo ( the diluent of active drug ) two sprays ( 100L/spray ) in each nostril three times/day for 2 months .
-METHODS	Nasal symptoms , including itching , sneezing , rhinorrhea , and obstruction , were assessed at baseline and after treatment .
-METHODS	Use of rescue medication , such as cetirizine syrup , was also evaluated .
-BACKGROUND	ClinicalTrials.gov ID NCT02130440 .
-RESULTS	Children treated with active drug achieved a significant reduction in all nasal symptoms : itching ( p = 0.0001 ) , sneezing ( p = 0.0009 ) , rhinorrhea ( p = 0.009 ) , and obstruction ( 0.002 ) as well as antihistamine use ( p = 0.003 ) .
-RESULTS	Placebo did not affect nasal complaints and cetirizine use .
-RESULTS	The intergroup analysis showed that active treatment was significantly superior to placebo about reduction of AR symptoms and rescue medication use .
-CONCLUSIONS	The present preliminary study firstly showed that intranasal resveratrol plus carboxymethyl -- glucan is capable of significantly improving nasal symptoms in children with pollen-induced AR .
-
-###24739113
-OBJECTIVE	To compare 4 analgesic protocols in dogs undergoing stifle joint surgery .
-METHODS	Randomized , blinded , prospective clinical trial .
-METHODS	Animals-48 client-owned dogs that underwent stifle joint surgery .
-METHODS	Dogs undergoing tibial plateau leveling osteotomy were randomly assigned to receive a constant rate infusion of a combination of morphine , lidocaine , and ketamine ; a lumbosacral epidural with morphine and ropivacaine ; both treatments ( ie , constant rate infusion and lumbosacral epidural ) ; or only IM premedication with morphine .
-METHODS	Indices of cardiorespiratory function and isoflurane requirement were recorded at 5-minute intervals during anesthesia .
-METHODS	A validated sedation scoring system and the modified Glasgow composite measure pain score were used to assess comfort and sedation after surgery and anesthesia once the swallowing reflex returned and a body temperature of 36.7 C ( 98.1 F ) was attained .
-METHODS	Pain and sedation scores were acquired at 60-minute intervals for 4 hours , then at 4-hour intervals for 24 hours .
-METHODS	Dogs with a postoperative pain score > 5 of 24 were given morphine as rescue analgesia .
-RESULTS	No differences in heart rate , respiratory rate , systolic arterial blood pressure , end-tidal Pco2 , end-tidal isoflurane concentration , and vaporizer setting were detected among groups .
-RESULTS	No differences in pain score , sedation score , rescue analgesia requirement , or time to first rescue analgesia after surgery were detected .
-CONCLUSIONS	Pain scores were similar among groups , and all 4 groups had similar rescue analgesia requirements and similar times to first administration of rescue analgesia .
-CONCLUSIONS	All 4 analgesic protocols provided acceptable analgesia for 24 hours after stifle joint surgery .
-
-###24331986
-BACKGROUND	The purpose of this study was to investigate the efficacy of a 1440-nm neodymium : yttrium-aluminum-garnet ( Nd : YAG ) laser on relieving pain in relation to the levels of inflammatory cytokine and neuropeptides in the root canal exudates of teeth with persistent symptomatic apical periodontitis .
-METHODS	Forty teeth with persistent symptomatic apical periodontitis were randomly assigned to treatment groups : group L , intracanal irradiation of 1440-nm Nd : YAG laser with a 300-m-diameter fiberoptic tip in addition to conventional root canal retreatment , and group C , conventional root canal re-treatment .
-METHODS	The degrees of both spontaneous pain and the pain on percussion before and after treatment were recorded , and root canal exudate samples were collected to quantify the associated levels of substance P , calcitonin gene-related peptide ( CGRP ) , and matrix metalloproteinase ( MMP ) -8 by immunoassay .
-RESULTS	All of the measured parameters were significantly reduced in group L ( P < .05 ) , whereas the level of pain on percussion , CGRP , and MMP-8 were significantly reduced in group C ( P < .05 ) .
-RESULTS	The 1440-nm Nd : YAG laser had significantly better effect on the relief of pain on percussion and the reduction of substance P , CGRP , and MMP-8 levels .
-RESULTS	The visual analog scale scores of perceived pain correlated with pain-related neuropeptides and inflammatory cytokine levels in root canal exudates .
-CONCLUSIONS	The 1440-nm Nd : YAG laser irradiation via fiberoptic tip to the teeth with persistent apical periodontitis provided promising consequences of pain and inflammation modulation .
-
-###26271567
-OBJECTIVE	Improving the treatment of advanced peritonitis via use in therapy antihypoxant Reamberin and hepatoprotector Remaxol , nutritional support , sanitation laparoscopic abdominal cavity .
-METHODS	A total of 232 children aged 1 to 15 years with generalized purulent peritonitis treated at the children 's surgical departments of Samara from 2001 to 2014 .
-METHODS	A study group comprised 148 patients who used the optimized pathogenetic therapy .
-METHODS	In the study group was allocated two groups : 64 patients in the pathogenetic therapy that used antihypoxant reamberin , and 84 children in the treatment of which reamberin and hepatoprotector remaxol .
-METHODS	All the children of the main group received nutritional support ( trophic feedings ) , used in the surgical treatment of abdominal laparoscopic sanitation .
-METHODS	Comprehensive survey includes the study of the dynamics of the level of white blood cells , leukocyte index on Kalf-Caliph , erythrocyte sedimentation rate , temperature , total albumin concentration , transaminase levels .
-RESULTS	Comparison of the studied parameters in the study and control groups , showed a more rapid decrease in the symptoms and signs of intoxication ( leukocytosis , LII , body temperature ) , relief of enteric disease , recovery of protein-synthetic function of the liver , a decrease of cytolytic and mesenchymal-inflammatory syndrome in the study group , especially in the subgroup in which therapy was included remaxol .
-CONCLUSIONS	Optimization of treatment involving the application of the combined drugs -- antihypoxant reamberin , hepatoprotector remaxol , nutritional support and implementation of laparoscopic abdominal sanitation led to improved results of therapy common purulent peritonitis in children .
-
-###24833736
-OBJECTIVE	We investigated whether sleep deprivation ( SD ) disturbs the tear film .
-METHODS	A total of 20 healthy male subjects with no ocular disease was recruited : 10 were allocated to the SD group and 10 to the control group The 10 subjects in the SD group were deprived of sleep in an experimental setting and their outcomes were compared to those of the control group , which was not sleep-deprived .
-METHODS	Tear film and ocular surface were evaluated at 2 PM , 10 PM , and 6 AM and 2 PM the following day .
-METHODS	Tear osmolarity , Schirmer 's test , tear film break-up time ( TBUT ) , pain on a visual analog scale ( VAS ) , and IOP were measured .
-RESULTS	At 6 AM the following day , mean tear osmolarity level increased ( P = 0.004 ) , TBUT was significantly shorter ( P = 0.01 ) , and tear secretion measured by Schirmer 's test was significantly reduced in the SD group than in the control group ( P = 0.004 ) .
-RESULTS	No significant change in IOP was observed in either group .
-CONCLUSIONS	Sleep deprivation induced tear hyperosmolarity , shortened TBUT , and reduced tear secretion , all of which can trigger the development of ocular surface diseases .
-CONCLUSIONS	Therefore , SD can exacerbate signs and symptoms in patients with ocular surface diseases .
-CONCLUSIONS	( ClinicalTrials.gov number , NCT02026986 . )
-
-###25727536
-OBJECTIVE	Treatment guidelines suggest distinctive medication strategies for first-episode and multiepisode patients with schizophrenia .
-OBJECTIVE	To assess the extent to which community clinicians adjust their usual treatment regimens for first-episode patients , the authors examined prescription patterns and factors associated with prescription choice in a national cohort of early-phase patients .
-METHODS	Prescription data at study entry were obtained from 404 participants in the Recovery After an Initial Schizophrenia Episode Project 's Early Treatment Program ( RAISE-ETP ) , a nationwide multisite effectiveness study for patients with first-episode schizophrenia spectrum disorders .
-METHODS	Treatment with antipsychotics did not exceed 6 months at study entry .
-RESULTS	The authors identified 159 patients ( 39.4 % of the sample ) who might benefit from changes in their psychotropic prescriptions .
-RESULTS	Of these , 8.8 % received prescriptions for recommended antipsychotics at higher than recommended dosages ; 32.1 % received prescriptions for olanzapine ( often at high dosages ) , 23.3 % for more than one antipsychotic , 36.5 % for an antipsychotic and also an antidepressant without a clear indication , 10.1 % for psychotropic medications without an antipsychotic , and 1.2 % for stimulants .
-RESULTS	Multivariate analysis showed evidence for sex , age , and insurance status effects on prescription practices .
-RESULTS	Racial and ethnic effects consistent with effects reported in previous studies of multiepisode patients were found in univariate analyses .
-RESULTS	Despite some regional variations in prescription practices , no region consistently had different practices from the others .
-RESULTS	Diagnosis had limited and inconsistent effects .
-CONCLUSIONS	Besides prescriber education , policy makers may need to consider not only patient factors but also service delivery factors in efforts to improve prescription practices for first-episode schizophrenia patients .
-
-###25726399
-BACKGROUND	The aim of this study was to evaluate the surface roughness and morphology of enamel with a surface roughness tester and scanning electron microscopy after the removal of metal brackets and polishing .
-METHODS	Ten orthodontic patients were selected for the study .
-METHODS	At the conclusion of orthodontic treatment , their metal brackets were removed .
-METHODS	For each patient , teeth on one side of the mouth were randomly chosen for finishing and polishing with aluminum oxide discs ( n = 10 ) .
-METHODS	Teeth on the other side were finished with multilaminated carbide burs ( n = 10 ) .
-METHODS	Dental replicas ( before and after tooth polishing ) were obtained with epoxy resin .
-METHODS	Three surface roughness measurements were made in different directions with an angle of 120 among them , and a mean for each dental replica was calculated .
-METHODS	The roughness data were statistically evaluated by repeated-measurements analysis of variance .
-METHODS	Three specimens from each group were also used for scanning electron microscopy analysis .
-RESULTS	After resin removal , the average roughness in the carbide bur group ( 0.31 m ) was significantly greater than that in the aluminum oxide disc group ( 0.25 m ) .
-CONCLUSIONS	The aluminum oxide disc polishing system resulted in less enamel roughness than did the multilaminated carbide bur system .
-
-###24612027
-BACKGROUND	Striae distensae ( SD ) is a common skin condition , with a prevalence ranging from 40 % to 90 % , depending on the population studied .
-OBJECTIVE	To evaluate the efficacy of superficial dermabrasion and compare it with that of topical tretinoin cream in the treatment of narrow and early SD .
-METHODS	Prospective , single-center , randomized , open-label study .
-METHODS	Thirty-two women presenting with early , untreated SD ( striae rubra ) were included in this study .
-METHODS	One group received 16 weekly sessions of superficial and localized dermabrasion , and the other used 0.05 % tretinoin cream daily .
-METHODS	Striae width and length were measured and compared between groups and over time .
-METHODS	Global Aesthetic Improvement Scale scores and subject satisfaction were also assessed .
-METHODS	Biopsies were performed for subjects who agreed to undergo this procedure , followed by histologic analyses of the skin samples .
-RESULTS	Both treatments were efficacious , with significant improvement in early SD from baseline , but there was no significant difference between the two treatments .
-RESULTS	Histologic assessment showed improvement in epidermal and dermal layers for the dermabrasion treatment group .
-CONCLUSIONS	Both treatments had similar efficacy , but superficial dermabrasion had a lower frequency of side effects and better adherence of the patients .
-
-###25438610
-OBJECTIVE	To assess the efficacy of a - galactomannan oligosaccharide ( - GMOS ) for the control of Salmonella infection in fattening pigs .
-RESULTS	Three different doses ( 0.5 , 3 and 2 kg - GMOS per ton of feed ) were used during the entire period of growing in three similar and independent field trials carried out in a small fattening unit ( 100 pigs ) .
-RESULTS	Treatment was randomly assigned to half of the pens .
-RESULTS	Individual serum samples ( 20-25 per group ) were collected at different times during the fattening period and a similar number of faecal samples during the fattening period and at slaughter .
-RESULTS	In addition , mesenteric lymph nodes were collected at slaughter .
-RESULTS	Herdcheck ( ) Swine Salmonella ELISA was used for serological analyses , the ISO 6579:2002 / Amd 1 : 2007 for bacteriology and the PFGE for molecular characterization of Salmonella strains .
-RESULTS	The addition of 2 kg t ( -1 ) of - GMOS to the pig diet during the entire fattening period was associated with a reduction in Salmonella prevalence , shedding and seroconversion .
-CONCLUSIONS	Feed supplementation with - GMOS may be a useful complementary tool for the control of salmonellosis in fattening pigs .
-CONCLUSIONS	- GMOS may be a complementary way of reducing Salmonella shedding and infection in fattening pigs .
-
-###26165370
-BACKGROUND	Musicians are a prone group to suffer from working-related musculoskeletal disorder ( WRMD ) .
-BACKGROUND	Conventional solutions to control musculoskeletal pain include pharmacological treatment and rehabilitation programs but their efficiency is sometimes disappointing .
-OBJECTIVE	The aim of this research is to study the immediate effects of Tuina techniques on WRMD of professional orchestra musicians from the north of Portugal .
-METHODS	We performed a prospective , controlled , single-blinded , randomized study .
-METHODS	Professional orchestra musicians with a diagnosis of WRMD were randomly distributed into the experimental group ( n = 39 ) and the control group ( n = 30 ) .
-METHODS	During an individual interview , Chinese diagnosis took place and treatment points were chosen .
-METHODS	Real acupoints were treated by Tuina techniques into the experimental group and non-specific skin points were treated into the control group .
-METHODS	Pain was measured by verbal numerical scale before and immediately after intervention .
-RESULTS	After one treatment session , pain was reduced in 91.8 % of the cases for the experimental group and 7.9 % for the control group .
-CONCLUSIONS	Although results showed that Tuina techniques are effectively reducing WRMD in professional orchestra musicians of the north of Portugal , further investigations with stronger measurements , double-blinding designs and bigger simple sizes are needed .
-
-###25744003
-BACKGROUND	Transcutaneous low-level tragus electrical stimulation ( LLTS ) suppresses atrial fibrillation ( AF ) in canines .
-OBJECTIVE	This study examined the antiarrhythmic and anti-inflammatory effects of LLTS in humans .
-METHODS	Patients with paroxysmal AF who presented for AF ablation were randomized to either 1 h of LLTS ( n = 20 ) or sham control ( n = 20 ) .
-METHODS	Attaching a flat metal clip onto the tragus produced LLTS ( 20 Hz ) in the right ear ( 50 % lower than the voltage slowing the sinus rate ) .
-METHODS	Under general anesthesia , AF was induced by burst atrial pacing at baseline and after 1 h of LLTS or sham treatment .
-METHODS	Blood samples from the coronary sinus and the femoral vein were collected at those time points and then analyzed for inflammatory cytokines , including tumor necrosis factor alpha and C-reactive protein , using a multiplex immunoassay .
-RESULTS	There were no differences in baseline characteristics between the 2 groups .
-RESULTS	Pacing-induced AF duration decreased significantly by 6.3 1.9 min compared with baseline in the LLTS group , but not in the control subjects ( p = 0.002 for comparison between groups ) .
-RESULTS	AF cycle length increased significantly from baseline by 28.8 6.5 ms in the LLTS group , but not in control subjects ( p = 0.0002 for comparison between groups ) .
-RESULTS	Systemic ( femoral vein ) but not coronary sinus tumor necrosis factor ( TNF ) - alpha and C-reactive protein levels decreased significantly only in the LLTS group .
-CONCLUSIONS	LLTS suppresses AF and decreases inflammatory cytokines in patients with paroxysmal AF .
-CONCLUSIONS	Our results support the emerging paradigm of neuromodulation to treat AF .
-
-###25291127
-OBJECTIVE	To evaluate the efficacy of a highly concentrated Lactobacillus salivarius preparation containing a gelling complex formed by Streptococcus thermophilus ST10 and tara gum in the treatment of atopic dermatitis ( AD ) .
-BACKGROUND	Previous studies have demonstrated an improvement in AD symptoms after administration of the probiotic strain L. salivarius LS01 .
-BACKGROUND	S. thermophilus ST10 and tara gum create a gelling complex that adheres to intestinal mucus and improves barrier function .
-METHODS	A prospective , controlled pilot trial was carried out to evaluate how the association of S. thermophilus ST10 and tara gum could improve the activity of L. salivarius LS01 administered at high doses to adults with AD .
-METHODS	Twenty-five patients were included into the study : 13 were treated for 1 month with the active formulation , whereas 12 represented the placebo group .
-METHODS	Scoring Atopic Dermatitis index was determined before and at the end of probiotic administration .
-METHODS	Fecal samples were also collected to evaluate changes in bacterial counts of Staphylococcus aureus and clostridia .
-RESULTS	A significant improvement in SCORAD index was observed in the probiotic group after 1 month of treatment , whereas no significant changes occurred in placebo patients .
-RESULTS	A slight decrease in fecal S. aureus count was observed in probiotic-treated patients .
-CONCLUSIONS	Data obtained in this study suggest a potential role for L. salivarius LS01 in the treatment of AD .
-CONCLUSIONS	The addition of tara gum and S. thermophilus ST10 seems to improve the overall efficacy of the probiotic strain , in particular shortening the time required for the onset of the positive effects .
-CONCLUSIONS	Further studies to investigate the activity of this preparation are advisable .
-
-###24968008
-OBJECTIVE	We previously reported a randomized , sham-controlled trial of 5 Hz dorsolateral prefrontal left - and right-side repetitive transcranial magnetic stimulation ( rTMS ) in 48 participants with a medically refractory major depressive disorder .
-OBJECTIVE	Depression improved most with right-side cranial stimulation , both rTMS and sham , and to a lesser degree with left rTMS .
-OBJECTIVE	Because depression is often associated with cognitive impairment , in this study we sought to determine whether our earlier participants had treatment-induced changes in cognition , which cognitive domains ( language , executive , visuospatial , verbal episodic memory , attention ) were affected , and whether treatment-induced cognitive changes were related either to improvement in depression or to other treatment variables , such as right versus left treatment and rTMS versus sham .
-METHODS	We used hierarchical regression analyses to determine how variables measured at baseline or associated with treatment affected changes in neuropsychological functions .
-METHODS	The variables were neuropsychological function in the 5 domains , severity of depression , change in depression with treatment , rTMS versus sham , laterality of stimulation , and rTMS-laterality interaction .
-RESULTS	Compared to sham , right rTMS was associated with 1.24 standard deviations greater gain in language function , 1.09 standard deviations greater gain in visuospatial function , and 2.38 standard deviations greater gain in verbal episodic memory than left rTMS .
-RESULTS	These improvements did not appear to be directly related to the relief from depression .
-CONCLUSIONS	Our results suggest that disorders of cognition and mood in depression may have different mechanisms , but right rTMS may treat both .
-CONCLUSIONS	We propose potential mechanisms underlying the right-side rTMS effect .
-BACKGROUND	Clinicaltrials.gov NCT00711568 .
-
-###25140770
-OBJECTIVE	To study the application value of asthma predictive index ( API ) - based group therapy in wheezing children under 5 years of age .
-METHODS	A total of 239 wheezing children under 5 years of age were divided into API-positive ( n = 126 ) and API-negative groups ( n = 113 ) .
-METHODS	Each group was randomly assigned to inhaled corticosteroids ( ICS ) subgroup and montelukast sodium ( leukotriene receptor antagonist , LTRA ) subgroup .
-METHODS	The ICS and LTRA subgroups received the same drug therapy at the same dosage within the first four weeks of treatment .
-METHODS	In the stable period of disease , the ICS subgroup only received aerosol inhalation of budesonide suspension , while the LTRA group was orally given montelukast sodium only .
-METHODS	Asthma symptom scores were assessed and recorded at different time points .
-RESULTS	In the first four weeks of treatment , ICS and LTRA were effective both in the API-positive and API-negative groups ; the two groups showed significant improvements in asthma symptom scores , and the asthma symptom score showed no significant difference between the ICS and LTRA subgroups of each group .
-RESULTS	After 24 weeks of treatment , the two therapies were still effective ; in the API-positive group , the LTRA subgroup had a better treatment outcome than the ICS subgroup , but there was no significant difference in treatment outcome between the LTRA and ICS subgroups of the API-negative group .
-CONCLUSIONS	For wheezing children under 5 years of age , therapeutic strategies can be chosen based on API in the stable period of disease , so as to better control wheezing .
-
-###25168526
-OBJECTIVE	To compare outcomes of diode laser vaporization of prostate with transurethral resection of the prostate ( TURP ) as a gold-standard treatment .
-METHODS	A total number of 115 patients with benign prostatic hyperplasia underwent TURP and 980-nm diode vaporization of prostate in a balanced randomization ( 1:1 ) from 2010 to 2012 and were followed up for 24 months .
-METHODS	Baseline characteristics of the patients , perioperative data , and postoperative outcomes were compared .
-METHODS	The primary end point of the study was assessing the values of International Prostate Symptom Score ( IPSS ) , and maximum flow rate ( Qmax ) to predict the functional improvement of each group .
-METHODS	The trial is registered at http://www.irct.ir ( number IRCT201202138146N3 ) .
-RESULTS	The mean age ( standard deviation ) of the patients was 68.2 7.8 years in TURP and 68.5 8.8 in diode groups .
-RESULTS	In TURP and diode groups , the operation time was 54.9 15.3 vs 60.6 22.6 minutes ( P = .14 ) , Foley catheterization time was 88.9 22.5 vs 20.1 4.6 hours ( P = .0001 ) and postoperative hospital stay was 59.9 14.4 vs 25.8 9.2 hours ( P = .0001 ) respectively .
-RESULTS	Outcome with regard to increase in Qmax , decrease in IPSS , and decrease in postvoid residual urine volume showed a dramatic improvement in both groups during the first 6 months .
-RESULTS	In the TURP group , the values of IPSS and Qmax were respectively lower and higher than diode patients at 12 and 24 months of follow-up .
-CONCLUSIONS	According to our study , diode laser vaporization ( 980 nm ) offers a safe and feasible procedure in the management of patients with symptomatic benign prostatic hypertrophy ; however , at longer follow-up the functional outcome of diode laser vaporization has been less efficient than TURP .
-
-###25365032
-OBJECTIVE	To investigate the effect of ingesting a caffeinated carbohydrate gel ( CC ) 10 minutes prior on 2000-m rowing performance compared with a carbohydrate-only placebo gel ( CP ) .
-METHODS	A counterbalanced , single-blind , crossover study design was employed ( N = 13 ) .
-METHODS	All participants completed 1 familiarization trial followed by 2 experimental rowing time trials .
-METHODS	The experimental trials were performed 10 min after ingesting CP ( 21.6 g of carbohydrate , 0 mg caffeine ) or CC ( 21.6 g carbohydrate , 100 mg caffeine ) , and heart rate ( HR ) , oxygen consumption ( VO2 ) , carbon dioxide production , minute ventilation ( VE ) , respiratory-exchange ratio ( RER ) , rating of perceived exertion ( RPE ) , gastrointestinal discomfort ( GI ) , and thirst perception ( Thirst ) were recorded every 200 m. Blood lactate [ La - ] was recorded immediately before and after exercise .
-RESULTS	A pairedsamples t test identified a significant improvement in 2000-m performance of 5.23.9 s ( 1.1 % 1.7 % ; P = .034 ) .
-RESULTS	Two-way repeated-measures ANOVA revealed no significant treatment effect for HR ( 1778 vs 1779 beats/min , P = .817 ) , VO2 ( 46.16.5 vs 46.66.2 mLkg ( -1 ) min ( -1 ) , P = .590 ) , VE ( 121.814.7 vs 124.815.7 L/min , P = .490 ) , RPE , GI , or Thirst for CP and CC , respectively .
-RESULTS	Paired-samples t tests revealed no treatment effect for postexercise [ La - ] between CP and CC ( 11.722.69 vs 12.263.13 mmol/L , P = .534 ) .
-CONCLUSIONS	A relatively low dose of caffeine ( 1.30.1 mg/kg body mass ) in an isotonic carbohydrate gel ingested only 10 min before performance improved 2000-m rowing time by 5.27.8 s ( 1.1 % 1.7 % ) .
-
-###24226490
-BACKGROUND	Pharyngolaryngeal discomfort is a significant complication following the use of laryngeal mask airway ( LMA ) .
-BACKGROUND	The present study aimed to investigate the relation of LMA cuff pressure and the occurrence of pharyngolaryngeal discomfort during spontaneous ventilation ( SV ) , pressure support ( PSV ) and pressure control ventilation ( PCV ) .
-METHODS	A hundred and twenty patients , ASA I-III , were included in this study .
-METHODS	Originally the patients were divided into three groups : the 1st group was left to breath spontaneously , the 2nd group was placed under PSV while PCV was used in the 3rd group .
-METHODS	Each group was divided into two subgroups : A ) intervention group ( maintaining cuff pressure at 60 cmH2O , measurement in 10 min intervals ) and B ) observation group ( no intervention in cuff pressure , measurement in 10 min intervals ) .
-METHODS	Anesthesia was induced with propofol and fentanyl and maintained with sevoflurane in air/oxygen .
-METHODS	Patients were assessed 2 and 24 hours post-surgery , for sore throat , dysphonia or dysphagia .
-RESULTS	A and B subgroup comparison at 24 hours revealed a statistically significant difference in the presence of pharyngolaryngeal discomfort in the PSV group ( 10 % versus 55 % respectively , P = 0.006 ) .
-RESULTS	Furthermore , when assessing the effect of maintaining a constant cuff pressure regardless of mode of ventilation , significantly fewer adverse effects were observed ( 8.3 % vs. 35 % , P = 0.001 ) when compared to the non-intervention subgroup .
-CONCLUSIONS	Maintaining LMA cuff pressure in values which do not exceed 60 cmH2O probably contributes in decreasing pharyngolaryngeal discomfort independently of ventilation mode .
-CONCLUSIONS	The ventilation mode which leads to the highest incidence of pharyngolaryngeal morbidity when cuff pressures are not closely monitored is PSV .
-
-###24330347
-BACKGROUND	Screening for vascular disease , risk assessment and management are encouraged in general practice however there is limited evidence about the emotional impact on patients .
-BACKGROUND	The Health Improvement and Prevention Study evaluated the impact of a general practice-based vascular risk factor intervention on behavioural and physiological risk factors in 30 Australian practices .
-BACKGROUND	The primary aim of this analysis is to investigate the psychological impact of participating in the intervention arm of the trial .
-BACKGROUND	The secondary aim is to identify the mediating effects of changes in behavioural risk factors or BMI .
-METHODS	This study is an analysis of a secondary outcome from a cluster randomized controlled trial .
-METHODS	Patients , aged 40-65 years , were randomly selected from practice records .
-METHODS	Those with pre-existing cardiovascular disease were excluded .
-METHODS	Socio-demographic details , behavioural risk factors and psychological distress were measured at baseline and 12 months .
-METHODS	The Kessler Psychological Distress Score ( K10 ) was the outcome measure for multi-level , multivariable analysis and a product-of-coefficient test to assess the mediating effects of behaviour change .
-RESULTS	Baseline data were available 384 participants in the intervention group and 315 in the control group .
-RESULTS	Twelve month data were available for 355 in the intervention group and 300 in the control group .
-RESULTS	The K10 score of patients in the intervention group ( 14.78 , SD 5.74 ) was lower at 12 months compared to the control group ( 15.97 , SD 6.30 ) .
-RESULTS	K10 at 12 months was significantly associated with the score at baseline and being unable to work but not with age , gender , change in behavioural risk factors or change in BMI .
-CONCLUSIONS	The reduction of K10 in the intervention group demonstrates that a general practice based intervention to identify and manage vascular risk factors did not adversely impact on the psychological distress of the participants .
-CONCLUSIONS	The impact of the intervention on distress was not mediated by a change in the behavioural risk factors or BMI , suggesting that there must be other mediators that might explain the positive impact of the intervention on emotional wellbeing .
-BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12607000423415 .
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-###24472633
-OBJECTIVE	This cluster randomized trial evaluated the efficacy of a disease and care management ( D&CM ) model in cardiovascular ( CVD ) prevention in primary care .
-RESULTS	Eligible subjects had 1 among : blood pressure 140/90 mmHg ; glycated hemoglobin 7 % ; LDL-cholesterol 160 or 100 mg/dL ( primary or secondary prevention , respectively ) ; BMI 30 ; current smoking .
-RESULTS	The D&CM intervention included a teamwork including nurses as care managers for the implementation of tailored care plans .
-RESULTS	Control group was allocated to usual-care .
-RESULTS	The main outcome was the proportion of subjects achieving recommended clinical targets for 1 of uncontrolled CVD risk factors at 12-month .
-RESULTS	During 2008-2009 we enrolled 920 subjects in the Abruzzo/Marche regions , Italy .
-RESULTS	Following the exclusion of L'Aquila due to 2009 earthquake , final analyses included 762 subjects .
-RESULTS	The primary outcome was achieved by 39.1 % ( 95 % CI : 34.2-44 .2 ) and 25.2 % ( 95 % CI : 20.9-29 .9 ) of subjects in the intervention and usual-care group , respectively ( p < 0.001 ) .
-RESULTS	The D&CM intervention significantly increased the proportion of subjects who achieved clinical targets for both diabetes and hypertension , with no differences in hypercholesterolemia , smoking status and obesity .
-CONCLUSIONS	The D&CM intervention was effective in controlling cardiovascular risk factors , in particular hypertension and diabetes .
-CONCLUSIONS	Numbers needed to treat were small .
-CONCLUSIONS	Such intervention may deserve further consideration in clinical practice .
-BACKGROUND	ACTRN12611000813987 .
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-###24394682
-OBJECTIVE	To evaluate a prevention program for infant sleep and cry problems and postnatal depression .
-METHODS	Randomized controlled trial with 781 infants born at 32 weeks or later in 42 well-child centers , Melbourne , Australia .
-METHODS	Follow-up occurred at infant age 4 and 6 months .
-METHODS	The intervention including supplying information about normal infant sleep and cry patterns , settling techniques , medical causes of crying and parent self-care , delivered via booklet and DVD ( at infant age 4 weeks ) , telephone consultation ( 8 weeks ) , and parent group ( 13 weeks ) versus well-child care .
-METHODS	Outcomes included caregiver-reported infant night sleep problem ( primary outcome ) , infant daytime sleep , cry and feeding problems , crying and sleep duration , caregiver depression symptoms , attendance at night wakings , and formula changes .
-RESULTS	Infant outcomes were similar between groups .
-RESULTS	Relative to control caregivers , intervention caregivers at 6 months were less likely to score > 9 on the Edinburgh Postnatal Depression Scale ( 7.9 % , vs 12.9 % , adjusted odds ratio [ OR ] 0.57 , 95 % confidence interval [ CI ] 0.34 to 0.94 ) , spend > 20 minutes attending infant wakings ( 41 % vs 51 % , adjusted OR 0.66 , 95 % CI 0.46 to 0.95 ) , or change formula ( 13 % vs 23 % , P < .05 ) .
-RESULTS	Infant frequent feeders ( > 11 feeds/24 hours ) in the intervention group were less likely to have daytime sleep ( OR 0.13 , 95 % CI 0.03 to 0.54 ) or cry problems ( OR 0.27 , 95 % CI 0.08 to 0.86 ) at 4 months .
-CONCLUSIONS	An education program reduces postnatal depression symptoms , as well as sleep and cry problems in infants who are frequent feeders .
-CONCLUSIONS	The program may be best targeted to frequent feeders .
-
-###24340314
-BACKGROUND	Helicobacter pylori infection occurs more frequently in Arctic Aboriginal settings than elsewhere in North America and Europe .
-BACKGROUND	Research aimed at reducing health risks from H pylori infection has been conducted in the Aboriginal community of Aklavik , Northwest Territories .
-OBJECTIVE	To compare the effectiveness of the Canadian standard therapy with an alternative therapy for eliminating H pylori infection in Aklavik .
-METHODS	Treatment-naive H pylori-positive individuals were randomly assigned to a 10-day regimen ( oral twice-daily doses ) with rabeprazole ( 20 mg ) : standard triple therapy ( proton pump inhibitor , added clarithromycin [ 500 mg ] and amoxicillin [ 1 g ] [ PPI-CA ] ) ; sequential therapy ( ST ) added amoxicillin ( 1 g ) on days 1 to 5 , and metronidazole ( 500 mg ) and clarithromycin ( 500 mg ) on days 6 to 10 .
-METHODS	Participants with clarithromycin-resistant H pylori were randomly assigned to ST or quadruple therapy .
-METHODS	Treatment effectiveness was estimated as per cent ( 95 % CI ) with a negative urea breath test at least 10 weeks after treatment .
-RESULTS	Of 104 ( 53 PPI-CA , 51 ST ) randomized participants , 89 ( 49 PPI-CA , 40 ST ) had post-treatment results .
-RESULTS	Per-protocol treatment effectiveness was 59 % ( 95 % CI 45 % to 73 % ) for PPI-CA and 73 % ( 95 % CI 58 % to 87 % ) for ST. Based on intention to treat , effectiveness was 55 % ( 95 % CI 41 % to 69 % ) for PPI-CA and 57 % ( 95 % CI 43 % to 71 % ) for ST. Of 77 participants ( 43 PPI-CA , 34 ST ) with 100 % adherence , effectiveness was 63 % ( 95 % CI 43 % to 82 % ) for PPI-CA and 81 % ( 95 % CI 63 % to 99 % ) for ST.
-CONCLUSIONS	While additional evidence is needed to confirm that ST is more effective for Arctic Aboriginal communities than the Canadian standard H pylori treatment , these results show standard PPI-CA treatment to be inadequate for communities such as Aklavik .
-
-###24697979
-OBJECTIVE	To assess pharmacokinetic and pharmacodynamic interactions between naproxen ( a non-steroidal anti-inflammatory drug ) and apixaban ( an oral , selective , direct factor-Xa inhibitor ) .
-METHODS	In this randomized , three period , two sequence study , 21 healthy subjects received a single oral dose of apixaban 10mg , naproxen 500mg or co-administration of both .
-METHODS	Blood samples were collected for determination of apixaban and naproxen pharmacokinetics and pharmacodynamics ( anti-Xa activity , international normalized ratio [ INR ] and arachidonic acid-induced platelet aggregation [ AAI-PA ] ) .
-METHODS	Adverse events , bleeding time and routine safety assessments were also evaluated .
-RESULTS	Apixaban had no effect on naproxen pharmacokinetics .
-RESULTS	However , following co-administration , apixaban AUC ( 0 , ) , AUC ( 0 , t ) and Cmax were 54 % ( geometric mean ratio 1.537 ; 90 % confidence interval ( CI ) 1.394 , 1.694 ) , 55 % ( 1.549 ; 90 % CI 1.400 , 1.713 ) and 61 % ( 1.611 ; 90 % CI 1.417 , 1.831 ) higher , respectively .
-RESULTS	Mean ( standard deviation [ SD ] ) anti-Xa activity at 3h post-dose was approximately 60 % higher following co-administration compared with apixaban alone , 4.4 [ 1.0 ] vs. 2.7 [ 0.7 ] IUml ( -1 ) , consistent with the apixaban concentration increase following co-administration .
-RESULTS	INR was within the normal reference range after all treatments .
-RESULTS	AAI-PA was reduced by approximately 80 % with naproxen .
-RESULTS	Co-administration had no impact beyond that of naproxen .
-RESULTS	Mean [ SD ] bleeding time was higher following co-administration ( 9.1 [ 4.1 ] min ) compared with either agent alone ( 5.8 [ 2.3 ] and 6.9 [ 2.6 ] min for apixaban and naproxen , respectively ) .
-CONCLUSIONS	Co-administration of naproxen with apixaban results in higher apixaban exposure and appears to occur through increased apixaban bioavailability .
-CONCLUSIONS	The effects on anti-Xa activity , INR and inhibition of AAI-PA observed in this study were consistent with the individual pharmacologic effects of apixaban and naproxen .
-
-###24973894
-BACKGROUND	There is presently no approved single treatment for dual alcohol and nicotine dependencies .
-OBJECTIVE	This pilot study investigated baclofen effects in alcoholic smokers .
-METHODS	This was a preliminary double-blind placebo-controlled randomized clinical study with 30 alcoholic smokers randomized to baclofen at 80 mg/day or placebo .
-METHODS	A subgroup ( n = 18 ) participated in an alcohol cue-reactivity experiment .
-RESULTS	Baclofen , compared with placebo , significantly decreased the percent days of abstinence from alcohol-tobacco co-use ( p = 0.004 ) .
-RESULTS	Alcohol dependence severity moderated baclofen effects , with the higher severity group having the greater baclofen response ( p < 0.001 ) .
-RESULTS	Although the percent days of alcohol-tobacco co-use declined in both groups , this decline was greater after placebo than baclofen ( p < 0.001 ) .
-RESULTS	Secondary analyses on alcohol or tobacco use alone suggested that the increase in percent days of co-abstinence was driven by the medication differences on heavy drinking days and on percent days smoking .
-RESULTS	In the cue-reactivity substudy , baclofen slightly decreased alcohol urge ( p = 0.058 ) and significantly reduced salivation ( p = 0.001 ) , but these effects were not related to cue type .
-CONCLUSIONS	This study provides preliminary evidence suggesting a possible role of baclofen in the treatment of alcoholic smokers .
-CONCLUSIONS	However , the mixed results and the small sample require larger confirmatory studies .
-
-###24307655
-OBJECTIVE	The purpose of this study is to evaluate the utilization of four approved antihyperuricemic agents in Taiwan before and after two safety announcements rescinded an indication for allopurinol and added a warning on benzbromarone-induced hepatotoxicity in the year 2005 .
-METHODS	An interrupted time series design and segmented regression models were used to examine impacts of the safety announcements on the utilization of allopurinol , benzbromarone , probenecid , or sulfinpyrazone .
-METHODS	All outpatient prescriptions of the four antihyperuricemic agents were extracted from a longitudinal cohort dataset with 1000000 individuals randomly sampled from the National Health Insurance Research Database .
-METHODS	We examined utilization patterns of antihyperuricemic agents before and after the policy intervention ( i.e. , safety announcements and labeling changes of allopurinol and benzbromarone ) in the year 2005 .
-RESULTS	Following the safety announcements , there was a reduction in the number of allopurinol users in the first year of intervention ( -95.82 users per 100000 persons , 95 % CI , [ -166.84 , -24.80 ] ) and a continuous reduction afterward at a rate of -53.17 per 100000 persons per year .
-RESULTS	The utilization of benzbromarone grew steadily before 2005 but decreased drastically after the intervention , with a 30.12 % reduction in the number of users by the end of year 2008 .
-RESULTS	There was no commensurate change in the number of probenecid or sulfinpyrazone users after the intervention .
-CONCLUSIONS	Further research is required to evaluate the direct impacts of the safety announcements on clinical outcomes , treatment costs , and patient 's quality of life .
-
-###24764674
-OBJECTIVE	To evaluate the efficacy and safety of esomeprazole-based triple therapy compared with lansoprazole therapy as first-line eradication therapy for patients with Helicobacter pylori ( H. pylori ) in usual post-marketing use in Japan , where the clarithromycin ( CAM ) resistance rate is 30 % .
-METHODS	For this multicenter , randomized , open-label , non-inferiority trial , we recruited patients ( 20 years of age ) with H. pylori infection from 20 hospitals in Japan .
-METHODS	We randomly allocated patients to esomeprazole therapy ( esomeprazole 20 mg , CAM 400 mg , amoxicillin ( AC ) 750 mg for the first 7 d , with all drugs given twice daily ) or lansoprazole therapy ( lansoprazole 30 mg , CAM 400 mg , AC 750 mg for the first 7 d , with all drugs given twice daily ) using a minimization method with age , sex , and institution as adjustment factors .
-METHODS	Our primary outcome was the eradication rate by intention-to-treat ( ITT ) and per-protocol ( PP ) analyses .
-METHODS	H. pylori eradication was confirmed by a urea breath test from 4 to 8 wk after cessation of therapy .
-RESULTS	ITT analysis revealed the eradication rates of 69.4 % ( 95 % CI : 61.2 % -76.6 % ) for esomeprazole therapy and 73.9 % ( 95 % CI : 65.9 % -80.6 % ) for lansoprazole therapy ( P = 0.4982 ) .
-RESULTS	PP analysis showed eradication rate of 76.9 % ( 95 % CI : 68.6 % -83.5 % ) for esomeprazole therapy and 79.8 % ( 95 % CI : 71.9 % -86.0 % ) for lansoprazole therapy ( P = 0.6423 ) .
-RESULTS	There were no differences in adverse effects between the two therapies .
-CONCLUSIONS	Esomeprazole showed non-inferiority and safety in a 7 day-triple therapy for eradication of H. pylori compared with lansoprazole .
-
-###24385282
-OBJECTIVE	Questions have been raised regarding nephrotoxicity from vancomycin .
-OBJECTIVE	A few small studies have shown that higher trough concentrations of vancomycin result in more nephrotoxicity .
-OBJECTIVE	The purpose of this study was to evaluate risk factors that may predispose patients to nephrotoxicity in those concomitantly receiving vancomycin .
-METHODS	This was a single-center retrospective chart review conducted on adult subjects 18 years and older who received at least three doses of vancomycin .
-METHODS	Exclusion criteria included sepsis , septic shock , or acute renal failure or stage 5 chronic kidney disease .
-METHODS	Subjects were divided into two groups : those who developed nephrotoxicity and those who did not .
-METHODS	Data collected included co-morbidities ( diabetes mellitus , hypertension , congestive heart failure ) , creatinine clearance ( CLCR ) , concomitant treatment with potentially nephrotoxic drugs , vancomycin trough concentrations , total daily dose , and duration of therapy .
-RESULTS	Seventy-seven subjects were included in the nephrotoxic group and 149 were in the control group .
-RESULTS	The proportion of men in the nephrotoxic group was higher ( 68 vs. 50 % , p = 0.0135 ) .
-RESULTS	Hypertension ( 74 vs. 51 % , p = 0.0009 ) , diabetes ( 49 vs. 30 % , p = 0.0046 ) , and furosemide use ( 65 vs. 39 % , p = 0.0009 ) were more common in the nephrotoxic group .
-RESULTS	The proportion of subjects with baseline CLCR 63.5 mL/min was higher in the nephrotoxic group .
-RESULTS	Furosemide use ( odds ratio [ OR ] 2.91 , 95 % CI 1.64-5 .15 ) , hypertension ( OR 2.74 , 95 % CI 1.5-5 .0 ) , and vancomycin trough concentration 16.2 g/mL ( OR 2.33 , 95 % CI 1.25-4 .44 ) were each associated with nephrotoxicity during vancomycin therapy .
-CONCLUSIONS	In summary , the patient profile exhibiting the greatest risk ( OR 4.99 ) of developing kidney injury is one who has hypertension , is receiving furosemide therapy , and has vancomycin trough concentrations 16.2 g/mL .
-
-###25492848
-OBJECTIVE	This study was performed to compare the pharmacokinetic properties and relative bioavailability of two isosorbide-5-mononitrate ( 5-ISMN ) sustained-release drugs in healthy Korean subjects under fasting and fed conditions .
-METHODS	A total of 60 healthy volunteers ( 30 each in the fasting and fed arms of the study ) were enrolled in the study and were randomized to treatment .
-METHODS	After the administration of a single dose of one of the investigational products , blood samples were collected at specific time intervals from 0 to 36 hours .
-METHODS	The plasma concentrations of 5-ISMN were measured by LC-MS/MS .
-METHODS	The pharmacokinetic parameters were calculated , and the 90 % confidence intervals ( CIs ) of the geometric mean ratio ( test/reference ) of the parameters were obtained by analysis of variance on logarithmically transformed data .
-RESULTS	The corresponding 90 % CIs of AUClast and Cmax for the test/reference geometric mean ratio were 90.75 - 98.44 % and 92.28 - 98.33 % , respectively , under fasting conditions .
-RESULTS	In the fed state study , the 90 % CIs for the geometric mean ratio of test to reference drugs were 94.79 - 103.33 % for AUClast and 99.86 - 108.02 % for Cmax .
-CONCLUSIONS	The test product is equivalent to the reference product in subjects under fasting and fed conditions within the Korean regulatory bioequivalence criteria .
-CONCLUSIONS	Both formulations were safe and well tolerated , and there were no noteworthy differences in the safety profiles between the test and reference drugs .
-
-###25297016
-BACKGROUND	In human beings , 5-HT6 receptors are almost exclusively expressed in the brain , particularly in areas relevant for cognition , such as the hippocampus and frontal cortex .
-BACKGROUND	We assessed the effect on cognitive performance of Lu AE58054 ( idalopirdine ) , a selective 5-HT6 receptor antagonist , in donepezil-treated patients with moderate Alzheimer 's disease .
-METHODS	For this randomised , double-blind , placebo-controlled phase 2 trial ( LADDER ) , we recruited patients from 48 outpatient clinical sites in seven countries .
-METHODS	Patients were 50 years or older , had moderate Alzheimer 's disease ( a mini-mental state examination score of 12-19 ) , and had been stably treated with donepezil 10 mg per day for 3 or more months .
-METHODS	Using a computer-generated sequence , we randomly assigned patients ( 1:1 , stratified by site ) to receive either idalopirdine 90 mg per day ( 30 mg thrice daily ) or placebo .
-METHODS	The primary endpoint was change from baseline in the 11-item Alzheimer 's Disease Assessment Scale-cognitive subscale ( ADAS-cog ) at week 24 .
-METHODS	We analysed all efficacy endpoints in the full-analysis set ( modified intention-to-treat analysis ) .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT01019421 .
-RESULTS	Between Dec 8 , 2009 , and Dec 23 , 2011 , we randomly allocated 278 patients to treatment : 133 to placebo and 145 to idalopirdine .
-RESULTS	132 patients in the placebo group and 140 in the experimental group were included in the final analysis .
-RESULTS	At week 24 , the change from baseline in ADAS-cog total score was +138 ( SD 053 ) in the placebo group and -077 ( 055 ) in the idalopirdine group ( treatment difference of -216 points , 95 % CI -362 to -069 ; p = 00040 ) .
-RESULTS	25 patients ( seven taking placebo and 18 taking idalopirdine ) discontinued treatment because of adverse events , the difference between groups being mainly due to asymptomatic transient increases in transaminase concentrations in some idalopirdine-treated patients .
-RESULTS	The most common adverse events ( occurring in > 3 % of patients ) were increased - glutamyltransferase ( 14 [ 10 % ] patients in the idalopirdine group vs two [ 2 % ] in the placebo group ) , diarrhoea ( six [ 4 % ] vs nine [ 7 % ] ) , urinary tract infection ( three [ 2 % ] vs nine [ 7 % ] ) , fall ( three [ 2 % ] vs eight [ 6 % ] ) , increased alanine aminotransferase ( nine [ 6 % ] vs none ) , and benign prostatic hyperplasia ( two [ 5 % ] vs none ) .
-RESULTS	Serious adverse events were reported by 14 ( 10 % ) patients in the idalopirdine group and 13 ( 10 % ) patients in the placebo group .
-RESULTS	One death occurred in each treatment group , neither were regarded as being related to treatment .
-CONCLUSIONS	Idalopirdine improved cognitive function in donepezil-treated patients with moderate Alzheimer 's disease .
-CONCLUSIONS	Larger studies in a broader population of patients are ongoing to substantiate the effects reported here .
-BACKGROUND	H Lundbeck A/S .
-
-###25125635
-BACKGROUND	Obstructive sleep apnea ( OSA ) can result in hypertension and significantly increase cardiovascular morbidity and mortality .
-BACKGROUND	There are few reports on the long-term effects of continuous positive airway pressure ( CPAP ) on blood pressure in patients with uncontrolled hypertension with coronary heart disease ( CHD ) and OSA .
-METHODS	We conducted a prospective , long-term follow-up study in 83 patients with uncontrolled hypertension , CHD , and OSA randomized to control or CPAP groups .
-METHODS	Daytime systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , and severe cardiovascular and cerebrovascular events ( SCCEs ) were recorded at baseline and follow-up .
-RESULTS	Seventy-three patients completed the study with a median follow-up of 36 ( interquartile range = 24-54 ) months .
-RESULTS	The 2 groups had similar characteristics at baseline .
-RESULTS	CPAP was used for 4.51.1 hour/night .
-RESULTS	SBP in the CPAP group was significantly reduced at follow-up ( 1437 mm Hg vs. 1397 mm Hg , P = 0.04 ) , and SBP decreased by 8mm Hg ( 95 % confidence interval = 1.4-9 .9 ; P = 0.01 ) .
-RESULTS	Hypertension control was improved ( CPAP , 69.4 % for CPAP users vs. 43.2 % for control subjects ; P = 0.02 ) ; however , DBP did not reach statistical difference between the groups ( 8110 mm Hg vs. 798 mm Hg ; P = 0.49 ) .
-RESULTS	In the CPAP group , the Epworth Sleepiness Scale was markedly reduced ( 7.03.4 vs. 3.72.3 ; P < 0.001 ) .
-RESULTS	There was 1 SCCE in the CPAP group ( heart failure ) , and 5 SCCEs in the control group ( acute myocardial infarction : 2 ( with 1 death ) ; stroke : 3 ) , but there was no significant difference identified .
-CONCLUSIONS	Long-term CPAP application in uncontrolled hypertension with CHD and OSA significantly reduced daytime SBP , improved hypertension control and daytime sleepiness , and decreased the trend in SCCEs compared with control subjects .
-BACKGROUND	ClinicalTrials.gov NCT02059993 .
-
-###24976224
-OBJECTIVE	To evaluate the long-term safety of a novel continuous infusion of ketorolac vs placebo after laparoscopic donor nephrectomy .
-METHODS	We performed a secondary analysis of a previously reported randomized controlled trial conducted from October 7 , 2008 , to July 21 , 2010 .
-METHODS	Patients aged 18-75 years received a continuous infusion of either ketorolac ( treatment [ n = 57 ] ) or normal saline ( control [ n = 54 ] ) for 24 hours immediately after laparoscopic donor nephrectomy .
-METHODS	Serum creatinine levels were measured at 1 - and 1.5-year follow-ups .
-METHODS	Glomerular filtration rate was calculated preoperatively , postoperatively , and at 1 - and 1.5-year follow-ups using the Chronic Kidney Disease Epidemiology Collaboration equation .
-METHODS	Glomerular filtration rates were compared between treatment and control groups using 2-sample t tests .
-RESULTS	Data analysis for the 111 donor nephrectomy patients showed that glomerular filtration rates decreased in both groups over time , but changes were not clinically significant .
-RESULTS	No difference was found in glomerular filtration rates ( in mL/min/1 .73 m2 ) between treatment and control groups at 1-year follow-up ( 89.29 vs 87.94 mL/min/1 .73 m2 ; P = .58 ) or at 1.5-year follow-up ( 88.54 vs 90.25 mL/min/1 .73 m2 ; P = .51 ) .
-CONCLUSIONS	The novel provision of continuous steady-state ketorolac is safe for postoperative pain control in patients after donor nephrectomy , with no change in glomerular filtration rates between treatment and control groups acutely and at up to 1.5-year follow-up .
-
-###24635460
-BACKGROUND	Induction of labor , an increasingly common intervention , is often preceded by the application of an agent to `` prime '' or `` ripen '' the cervix .
-BACKGROUND	We conducted a randomized controlled trial to compare clinical , economic , and psychosocial outcomes of inpatient and outpatient cervical priming before induction of labor .
-BACKGROUND	In this paper we present the psychosocial outcomes .
-METHODS	Women participating in a randomized controlled trial in two Australian metropolitan teaching hospitals completed questionnaires to measure anxiety and depression at enrollment , and to examine satisfaction , experiences , depression , and infant feeding 7 weeks after giving birth .
-METHODS	Data analysis was by intention to treat and by having received the intervention as intended ( approximately 50 % in each group ) .
-RESULTS	Of 1,004 eligible women , 85 percent consented ( n = 407 , outpatient ; n = 414 inpatient ) .
-RESULTS	No statistically significant or clinically relevant differences were found in immediate anxiety , depression , or infant feeding .
-RESULTS	Small , statistically significant differences favoring outpatient priming were found in seven of the nine subscales in the 7-week postpartum questionnaire .
-RESULTS	The direction of the effect was maintained , mostly with a larger effect size in women who received the intervention .
-CONCLUSIONS	Women allocated to outpatient priming were more satisfied with their priming experience than women allocated to inpatient priming .
-CONCLUSIONS	Being informed that they could go home after cervical priming did not increase women 's anxiety .
-
-###25012432
-BACKGROUND	It has not been examined trialed whether obsessive compulsive symptoms in patients with bipolar disorder respond to topiramate as an adjuvant treatment .
-METHODS	This 4-month double-blind placebo-controlled randomized clinical trial examined the efficacy and safety of augmentation with topiramat for treating the patients with bipolar disorder , manic phase type-I , and obsessive compulsive disorder symptoms .
-METHODS	Both groups received lithium + olanzapine + clonazepam .
-METHODS	However , one group received topiramate and the other group placebo as adjuvant medications .
-METHODS	Yale Brown obsessive compulsive behavior scale was used to assess the outcome .
-METHODS	Adverse effects were also recorded .
-RESULTS	A total of 32 patients completed this trial .
-RESULTS	The mean score decreased from 24.2 ( 4.8 ) to 17.6 ( 8.7 ) in the topiramate group ( P < 0.003 ) and from 20.9 ( 2.9 ) to 9.6 ( 3.5 ) in the placebo group during this trial ( P < 0.0001 ) .
-RESULTS	Additionally , 9 ( 52.9 % ) out of 17 patients in the topiramate group and 2 ( 12.5 % ) out of 16 patients in the placebo group showed more than 34 % decline in YBOC score ( x2 = 6.0 , df = 1 , P < 0.01 ) .
-RESULTS	No serious adverse effects were detected .
-CONCLUSIONS	The limitations of the present study were its small sample size and the fact that it was conducted in a single center .
-CONCLUSIONS	The combination of lithium + olanzapine + clonazepam decreased the symptoms of obsessive compulsive disorder in the patients with bipolar disorder type I. However , topiramate had a more significant effect than placebo on improvement of the patients with bipolar disorder and obsessive compulsive symptoms .
-CONCLUSIONS	This combination seems to be without serious adverse effects .
-
-###24521895
-OBJECTIVE	To explore the effective therapy of female overactive bladder unresponsive to behavior training .
-METHODS	A total of 67 patients with female overactive bladder unresponsive to behavior training were enrolled from January 2012 to January 2013 at Liaocheng Second People 's Hospital .
-METHODS	They were randomized into trial and control groups ( Iand II ) .
-METHODS	Their mean age was 39.8 ( 19-57 ) years .
-METHODS	And the mean disease course was 3.8 ( 1-16 ) years .
-METHODS	The trial group ( n = 24 ) received oral formulations of solifenacin succinate ( 5 mg , once a day ) and naftopidil ( 25 mg , every evening ) .
-METHODS	The control group I ( n = 22 ) had only solifenacin succinate and the control group II ( n = 21 ) only naftopidil .
-METHODS	The treatment lasted for 4 weeks .
-METHODS	The time of urination per day , average amount of mona-urination and maximum amount of mona-urination were observed .
-METHODS	The changes of all parameters before and after treatment were assessed .
-METHODS	And statistic analysis was performed .
-RESULTS	The urinary urgency score of the trial , control group I and control II groups were 0.8 0.1 , 1.8 0.8 , 2.1 0.9 ; and the times of urination per day 9 4 , 13 4 , 14 5 , average amount of mona-urination ( 295 79 ) , ( 211 67 ) , ( 185 64 ) ml and maximum amount of mona-urination ( 352 88 ) , ( 292 75 ) , ( 235 69 ) ml respectively .
-RESULTS	These parameters showed significant differences between the trial and control groups ( all P < 0.05 ) .
-CONCLUSIONS	A combination of solifenacin succinate and naftopidil can effectively relieve the symptoms of female overactive bladder and improve the life quality .
-
-###25315149
-BACKGROUND	Avascular necrosis of femoral head ( ANFH ) is a progressive disease that often leads to hip joint dysfunction and even disability in young patients .
-BACKGROUND	Although the standard treatment , which is core decompression , has the advantage of minimal invasion , the efficacy is variable .
-BACKGROUND	Recent studies have shown that implantation of bone marrow containing osteogenic precursors into necrotic lesion of ANFH may be promising for the treatment of ANFH .
-METHODS	A prospective , double-blinded , randomized controlled trial was conducted to examine the effect of bone-marrow buffy coat ( BBC ) grafting combined with core decompression for the treatment of ANFH .
-METHODS	Forty-five patients ( 53 hips ) with Ficat stage I to III ANFH were recruited .
-METHODS	The hips were allocated to the control group ( core decompression + autologous bone graft ) or treatment group ( core decompression + autologous bone graft with BBC ) .
-METHODS	Both patients and assessors were blinded to the treatment options .
-METHODS	The clinical symptoms and disease progression were assessed as the primary and secondary outcomes .
-RESULTS	At the final follow-up ( 24 months ) , there was a significant relief in pain ( P < 0.05 ) and clinical joint symptoms as measured by the Lequesne index ( P < 0.05 ) and Western Ontario and McMaster Universities Arthritis Index ( P < 0.05 ) in the treatment group .
-RESULTS	In addition , 33.3 % of the hips in the control group have deteriorated to the next stage after 24 months post-procedure , whereas only 8 % in the treatment group had further deterioration ( P < 0.05 ) .
-RESULTS	More importantly , the non-progression rates for stage I/II hips were 100 % in the treatment group and 66.7 % in the control group .
-CONCLUSIONS	Implantation of the autologous BBC grafting combined with core decompression is effective to prevent further progression for the early stages of ANFH .
-BACKGROUND	ClinicalTrials.gov identifier NCT01613612 .
-BACKGROUND	Registered 13 December 2011 .
-
-###24460845
-BACKGROUND	As the population ages , more people are suffering from long-term health conditions ( LTCs ) .
-BACKGROUND	Health services around the world are exploring new ways of supporting people with LTCs and there is great interest in the use of telehealth : technologies such as the Internet , telephone and home self-monitoring .
-METHODS	This study aims to evaluate the effectiveness and cost-effectiveness of a telehealth intervention delivered by NHS Direct to support patients with LTCs .
-METHODS	Two randomized controlled trials will be conducted in parallel , recruiting patients with two exemplar LTCs : depression or raised cardiovascular disease ( CVD ) risk .
-METHODS	A total of 1,200 patients will be recruited from approximately 42 general practices near Bristol , Sheffield and Southampton , UK .
-METHODS	Participants will be randomly allocated to either usual care ( control group ) or usual care plus the NHS Direct Healthlines Service ( intervention group ) .
-METHODS	The intervention is based on a conceptual model incorporating promotion of self-management , optimisation of treatment , coordination of care and engagement of patients and general practitioners .
-METHODS	Participants will be provided with tailored help , combining telephone advice from health information advisors with support to use a range of online resources .
-METHODS	Participants will access the service for 12 months .
-METHODS	Outcomes will be collected at baseline , four , eight and 12 months for the depression trial and baseline , six and 12 months for the CVD risk trial .
-METHODS	The primary outcome will be the proportion of patients responding to treatment , defined in the depression trial as a PHQ-9 score < 10 and an absolute reduction in PHQ-9 5 after 4 months , and in the CVD risk trial as maintenance or reduction of 10-year CVD risk after 12 months .
-METHODS	The study will also assess whether the intervention is cost-effective from the perspective of the NHS and personal social services .
-METHODS	An embedded qualitative interview study will explore healthcare professionals ' and patients ' views of the intervention .
-CONCLUSIONS	This study evaluates a complex telehealth intervention which combines evidence-based components and is delivered by an established healthcare organisation .
-CONCLUSIONS	The study will also analyse health economic information .
-CONCLUSIONS	In doing so , the study hopes to address some of the limitations of previous research by demonstrating the effectiveness and cost-effectiveness of a real world telehealth intervention .
-BACKGROUND	Current Controlled Trials : Depression trial ISRCTN14172341 and cardiovascular disease risk trial ISRCTN27508731 .
-
-###25148846
-BACKGROUND	Robotically facilitated therapeutic activities , performed in virtual environments have emerged as one approach to upper extremity rehabilitation after stroke .
-BACKGROUND	Body function level improvements have been demonstrated for robotically facilitated training of the arm .
-BACKGROUND	A smaller group of studies have demonstrated modest activity level improvements by training the hand or by integrated training of the hand and arm .
-BACKGROUND	The purpose of this study was to compare a training program of complex hand and finger tasks without arm movement paired with a separate set of reaching activities performed without hand movement , to training the entire upper extremity simultaneously , utilizing integrated activities .
-METHODS	Forty individuals with chronic stroke recruited in the community , participated in a randomized , blinded , controlled trial of two interventions .
-METHODS	Subjects were required to have residual hand function for inclusion .
-METHODS	The first , hand and arm separate ( HAS ) training ( n = 21 ) , included activities controlled by finger movement only , and activities controlled by arm movement only , the second , hand and arm together ( HAT ) training ( n = 20 ) used simulations controlled by a simultaneous use of arm and fingers .
-RESULTS	No adverse reactions occurred .
-RESULTS	The entire sample demonstrated mean improvements in Wolf Motor Function Test scores ( 21 % ) and Jebsen Test of Hand Function scores ( 15 % ) , with large effect sizes ( partial r2 = .81 and r2 = .67 , respectively ) .
-RESULTS	There were no differences in improvement between HAS and HAT training immediately after the study .
-RESULTS	Subjects in the HAT group retained Wolf Motor Function Test gains better than in the HAS group measured three months after the therapy but the size of this interaction effect was small ( partial r2 = .17 ) .
-CONCLUSIONS	Short term changes in upper extremity motor function were comparable when training the upper extremity with integrated activities or a balanced program of isolated activities .
-CONCLUSIONS	Further study of the retention period is indicated .
-BACKGROUND	NCT01072461 .
-
-###24329045
-BACKGROUND	The aim of this randomized clinical trial ( RCT ) was to investigate whether 6-month continuous use of different manual toothbrushes ( TBs ) influences plaque removal and the degree of gingival inflammation compared to short utilization periods of 4 weeks each .
-METHODS	In total , 96 participants were randomly allocated into two groups : continuous use during 6 months ( non-renewal group ) or a change in TB every 4 weeks during 6 months ( renewal group ) .
-METHODS	Each group was subdivided into four subgroups ( groups A to H ; n = 12 each ) according to the head size ( normal or short ) and bristle hardness ( medium or soft ) of the TB used .
-METHODS	The modified Quigley-Hein plaque index ( QHI ) , papilla bleeding index ( PBI ) , and gingival index ( GI ) were recorded at baseline and 2 , 8 , 12 , 16 , and 24 weeks after baseline .
-METHODS	After 24 weeks , each participant received a new TB , and at week 26 , the final QHI , PBI , and GI were determined .
-METHODS	The statistical evaluation consisted of analysis of covariance ( P < 0.05 ) .
-RESULTS	With time , QHI , PBI , and GI were significantly different between the renewal and the non-renewal groups ( QHI : P = 0.02 ; PBI : P = 0.04 ; GI : P < 0.01 ) , independent of subgroup .
-RESULTS	In the renewal group , QHI showed a significant decrease between baseline and each follow-up visit ( P < 0.01 ) .
-RESULTS	In the non-renewal group , there was a significant decrease compared to baseline up to and including week 16 ( P < 0.01 ) .
-RESULTS	PBI in the renewal group showed no significant differences between baseline and each follow-up visit ( P > 0.05 ) .
-RESULTS	In the non-renewal group , only the normal head/soft subgroup exhibited a significant increase at week 24 ( P = 0.02 ) .
-RESULTS	The GI in the renewal group showed no difference between baseline and all follow-up visits , whereas in the non-renewal group , there was a significant decrease up to and including week 12 ( P < 0.05 ) .
-CONCLUSIONS	Six-month continuous use reduced the effectiveness of the TB with respect to plaque removal , and gingival inflammation appeared to increase .
-
-###24622668
-BACKGROUND	Metformin is the only first-line oral hypoglycaemic drug for type 2 diabetes recommended by international guidelines with proven efficacy , safety , and cost-effectiveness .
-BACKGROUND	However , little information exists about its use in Asian populations .
-BACKGROUND	We aimed to ascertain the effectiveness of the - glucosidase inhibitor acarbose , extensively adopted in China , compared with metformin as the alternative initial therapy for newly diagnosed type 2 diabetes .
-METHODS	In this 48-week , randomised , open-label , non-inferiority trial , patients who were newly diagnosed with type 2 diabetes , with a mean HbA1c of 75 % , were enrolled from 11 sites in China .
-METHODS	After a 4-week lifestyle modification run-in , patients were assigned to 24 weeks of monotherapy with metformin or acarbose as the initial treatment , followed by a 24-week therapy phase during which add-on therapy was used if prespecified glucose targets were not achieved .
-METHODS	Primary endpoints were to establish whether acarbose was non-inferior to metformin in HbA1c reduction at week 24 and week 48 timepoints .
-METHODS	The non-inferiority margin was 03 % , with an expected null difference in the change from baseline to week 48 in HbA1c .
-METHODS	Analysis was done on a modified intention-to-treat population .
-METHODS	This study was registered with Chinese Clinical Trial Registry , number ChiCTR-TRC-08000231 .
-RESULTS	Of the 788 patients randomly assigned to treatment groups , 784 patients started the intended study drug .
-RESULTS	HbA1c reduction at week 24 was -117 % in the acarbose group and -119 % in the metformin group .
-RESULTS	At week 48 , the HbA1c reduction was -111 % ( acarbose ) and -112 % ( metformin ) with difference 001 % ( 95 % CI -012 to 014 , p = 08999 ) .
-RESULTS	Six ( 2 % ) patients in the acarbose group and seven ( 2 % ) patients in the metformin group had serious adverse events , and two ( 1 % ) and four ( 1 % ) had hypoglycaemic episodes .
-CONCLUSIONS	This study provides evidence that acarbose is similar to metformin in efficacy , and is therefore a viable choice for initial therapy in Chinese patients newly diagnosed with type 2 diabetes .
-BACKGROUND	Bayer Healthcare ( China ) and Double Crane Phama .
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-###24899217
-BACKGROUND	Seasonal allergic rhinitis is typically poorly managed , particularly in adolescents , in whom it is responsible for considerable morbidity .
-BACKGROUND	Our previous work has demonstrated that if poorly controlled this can impair educational performance .
-OBJECTIVE	The primary aim of this trial was to assess the impact of a primary care-based professional training intervention on clinical outcomes in adolescents with seasonal allergic rhinitis .
-METHODS	Cluster trial in which UK general practice staff were randomised to a short , intensive workshop on the evidence-based management of seasonal allergic rhinitis .
-METHODS	The primary outcome measure was the change in the validated Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities ( RQLQ ( S ) ) score between baseline and 6 weeks post intervention ( minimal clinically important difference = 0.5 ) .
-METHODS	Secondary outcome measures of interest included health-care professionals ' knowledge and confidence in managing seasonal allergic rhinitis , number of seasonal allergic rhinitis-related consultations , relevant treatments prescribed and symptom scores .
-RESULTS	Thirty-eight general practices were randomised ( 20 in the intervention arm ) and 246 patients ( 50.2 % males , mean age 15 years ) were included in the primary outcome analysis .
-RESULTS	Health-care professionals ' knowledge and confidence of the clinical management of seasonal allergic rhinitis improved .
-RESULTS	This did not , however , result in clinically or statistically significant improvements in RQLQ ( S ) : -0.15 , ( 95 % confidence interval , -0.5 to +0.2 ) .
-RESULTS	There were no differences in consultation frequency , treatments issued for seasonal allergic rhinitis or symptom scores .
-CONCLUSIONS	Although associated with increases in professionals ' self-assessed confidence and understanding of seasonal allergic rhinitis management , this intensive training workshop did not translate into improvements in adolescents ' disease-specific quality of life or a reduction in rhinitis symptoms .
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-###24312459
-OBJECTIVE	To examine the extent to which individual and ecological-level cognitive and structural social capital are associated with common mental disorder ( CMD ) , the role played by physical characteristics of the neighbourhood in moderating this association , and the longitudinal change of the association between ecological level cognitive and structural social capital and CMD .
-METHODS	Cross-sectional and longitudinal study of 40 disadvantaged London neighbourhoods .
-METHODS	We used a contextual measure of the physical characteristics of each neighbourhood to examine how the neighbourhood moderates the association between types of social capital and mental disorder .
-METHODS	We analysed the association between ecological-level measures of social capital and CMD longitudinally .
-METHODS	4,214 adults aged 16-97 ( 44.4 % men ) were randomly selected from 40 disadvantaged London neighbourhoods .
-METHODS	General Health Questionnaire ( GHQ-12 ) .
-RESULTS	Structural rather than cognitive social capital was significantly associated with CMD after controlling for socio-demographic variables .
-RESULTS	However , the two measures of structural social capital used , social networks and civic participation , were negatively and positively associated with CMD respectively .
-RESULTS	` Social networks ' was negatively associated with CMD at both the individual and ecological levels .
-RESULTS	This result was maintained when contextual aspects of the physical environment ( neighbourhood incivilities ) were introduced into the model , suggesting that ` social networks ' was independent from characteristics of the physical environment .
-RESULTS	When ecological-level longitudinal analysis was conducted , ` social networks ' was not statistically significant after controlling for individual-level social capital at follow up .
-CONCLUSIONS	If we conceptually distinguish between cognitive and structural components as the quality and quantity of social capital respectively , the conclusion of this study is that the quantity rather than quality of social capital is important in relation to CMD at both the individual and ecological levels in disadvantaged urban areas .
-CONCLUSIONS	Thus , policy should support interventions that create and sustain social networks .
-CONCLUSIONS	One of these is explored in this article .
-BACKGROUND	Controlled-Trials .
-BACKGROUND	com ISRCTN68175121 http://www.controlled-trials.com/ISRCTN68175121 .
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-###26387418
-OBJECTIVE	To determine the effects of Thai massage on muscle spasticity in young people with cerebral palsy .
-METHODS	Young people with spastic diplegia , aged 6-18 years old , were recruitedfrom the Srisungwan School in Khon Kaen Province .
-METHODS	Spasticity of right quadriceps femoris muscles was measured using Modified Ashworth Scale ( MAS ) at pre - and immediately post 30-minute session of Thai massage .
-METHODS	Thai massage was applied on the lower back and lower limbs .
-METHODS	Wilcoxon Signed Ranks test was used to compare the outcome between pre - and post treatment .
-RESULTS	Seventeen participants with spastic diplegia aged 13.71 + / - 3.62 years old participated .
-RESULTS	A significant difference of MAS was observed between pre - and post treatment ( 1 + , 1 ; p < 0.01 ) .
-RESULTS	No adverse events were reported .
-CONCLUSIONS	Thai massage decreased muscle spasticity and is suggested to be an alternative treatmentfor reducing spasticity in young people with cerebral palsy .
-
-###25547003
-BACKGROUND	Peritoneal implantation metastasis of gastric cancer is the major reason for cancer recurrence after radical operations .
-BACKGROUND	As a new chemotherapeutic agent , raltitrexed has been widely used in intravenous chemotherapy for many kinds of cancers .
-BACKGROUND	However , no study has reported the efficacy and safety of raltitrexed in intraperitoneal chemotherapy .
-BACKGROUND	This study aimed to explore the safety of intraperitoneal chemotherapy with raltitrexed during gastric cancer operation compared to normal saline ( NS ) rinsing of the abdominal cavity .
-METHODS	In this prospective study , 91 gastric cancer patients undergoing surgery and reconstruction were consecutively enrolled and randomly assigned into two groups .
-METHODS	Raltitrexed in NS ( 500 ml ) was injected into the abdominopelvic cavity for the patients in the RT group ( n = 48 ) , while for the patients in the group NS ( n = 43 ) , only NS ( 500 ml ) was injected .
-METHODS	The postoperative complications , gas passage time , and adverse effects , according to NCI-CTCAE v3 .0 , were compared between the two groups .
-RESULTS	There were no significant differences in age , sex , cancer pathological type , clinical stage or operation method between the two groups ( all P > 0.05 ) .
-RESULTS	No significant difference was observed in adverse effects and postoperative complications between the two groups ( all P > 0.05 ) .
-RESULTS	No significant change was found in the levels of red blood cells , white blood cells , platelets , lactate dehydrogenase , blood urea nitrogen , and alanine aminotransferase before and after the operation for both groups ( all P > 0.05 ) .
-RESULTS	All adverse events were mild or moderate by NCI-CTCAE v3 .0 ( National Cancer Institute common terminology criteria for adverse events ) grade .
-CONCLUSIONS	The findings of the present study demonstrate that intraperitoneal chemotherapy with raltitrexed after gastric cancer operation is safe and could be used for patients .
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-###24465438
-BACKGROUND	Despite growing attention to nutrition and quality of life in cardiovascular disease survivors , the impact of dietary factors according to disease type or to quality of life domain is poorly understood .
-BACKGROUND	We investigated the effects of B vitamin and/or n-3 fatty acid supplementation on health-related quality of life among survivors of stroke , myocardial infarction , or unstable angina .
-METHODS	We performed ancillary analyses of the SU.FOL.OM3 trial ( 2003-2009 ; France ) .
-METHODS	In total , 2,501 men ( mean age = 61 y ) and women ( mean age = 63 y ) were randomized in a 22 factorial design to : 1 ) 0.56 mg 5-methyl-tetrahydrofolate , 3 mg vitamin B6 , 0.02 mg vitamin B12 ; 2 ) 600 mg eicosapentaenoic and docosahexaenoic acids in a 21 ratio ; 3 ) B vitamins and n-3 fatty acids combined ; or 4 ) placebo .
-METHODS	Health-related quality of life was evaluated at follow-up with the Medical Outcomes Study 36-Item Short Form Health Survey .
-METHODS	Data from 2,029 individuals were used in this analysis .
-RESULTS	After 3.10.4 y , no effects of supplementation with either B vitamins or n-3 fatty acids on quality of life ( physical or mental health domains ) were found .
-RESULTS	However , participants receiving B vitamins had slightly more activity limitations due to emotional problems compared with those not receiving B vitamins ( mean difference = 3.8 ; 95 % CI : 0.4 , 7.1 ) .
-RESULTS	A significant interaction of treatment by prior disease revealed an inverse association between n-3 fatty acids and vitality among myocardial infarction survivors ( mean difference = 2.9 ; 95 % CI : 0.5 , 5.2 ) .
-CONCLUSIONS	There were no beneficial effects of supplementation with relatively low doses of B vitamins or n-3 fatty acids on health-related quality of life in cardiovascular disease survivors .
-CONCLUSIONS	The adverse effects of B vitamins on activity limitations and of n-3 fatty acids on vitality among individuals with prior myocardial infarction merit confirmation .
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-###24231226
-BACKGROUND	Declining cognition is a risk factor for falls among older adults .
-BACKGROUND	The extent to which impaired judgment in performance of daily activities increases fall risk is unclear .
-OBJECTIVE	The aim of this study was to determine whether engagement in mobility activities in a risky manner explains the association between declining cognition and rate of falls .
-METHODS	This study was a secondary analysis of baseline and prospective data from older adults enrolled in the intervention arm of a randomized clinical trial .
-METHODS	Two hundred forty-five community-dwelling older adults ( 79 % female ; mean age = 79 years , SD = 8.0 ) who were at risk for falls received physical , cognitive , and functional evaluations .
-METHODS	Cognition was assessed with the Short Portable Mental Status Questionnaire ( SPMSQ ) .
-METHODS	Using interview and in-home assessment data , physical therapists determined whether participants were at risk for falls when performing mobility-related activities of daily living ( ADL ) and instrumental ADL ( IADL ) .
-METHODS	Falls were measured prospectively for 1 year using monthly falls diaries .
-RESULTS	Declining cognition was associated with increased number of mobility activities designated as risky ( 1.5 % of mobility activities performed in a risky manner per SPMSQ point ) and with increased rate of falls ( rate ratio = 1.16 for each unit change in SPMSQ score ) .
-RESULTS	Risky performance of mobility activities mediated the relationship between cognition and rate of falls .
-CONCLUSIONS	Risk assessment was based on the clinical judgment of experienced physical therapists .
-CONCLUSIONS	Cognition was measured with a relatively insensitive instrument , and only selected mobility activities were evaluated .
-CONCLUSIONS	Engagement in mobility ADL and IADL tasks in a risky manner emerged as a link between declining cognition and increased number of falls , suggesting a mechanism through which the rate of falls may increase .
-CONCLUSIONS	Specifically , declining cognition is associated with performance of mobility activities in an unsafe manner , thereby increasing the risk for falls .
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-###25573141
-OBJECTIVE	To measure the feasibility , safety , and efficacy of the cranial cup device in a sample of hospitalized infants at risk for deformational plagiocephaly ( DP ) .
-METHODS	A multisite , stratified , and randomized single-blinded study .
-METHODS	Neonatal intensive care units ( NICU ) from three urban and one suburban hospital participated .
-METHODS	Subjects included 62 infants with lengths of stay 14 days .
-METHODS	Nurses caring for infants in study group 1 used the moldable positioner .
-METHODS	In study group 2 , nurses rotated the moldable positioner and cranial cup devices using the cranial cup for a target goal of 12 hours/day .
-METHODS	Both study groups received routine position changes .
-METHODS	Outcome measures included hours of device use ( feasibility ) , cardiorespiratory and emesis events ( safety ) , and cranial measurements obtained at discharge ( efficacy ) by one of four , licensed orthotists who were blinded to the study .
-RESULTS	A total of 35 infants were randomized to study group 1 ( moldable positioner ) and 27 infants to study group 2 ( moldable positioner and cranial cup ) .
-RESULTS	The median hours per day on the cranial cup was 10.7 ( range 4.5-15 .3 ) .
-RESULTS	Emesis and cardiorespiratory events were equally distributed for the moldable positioner and cranial cup devices in study group 2 .
-RESULTS	At discharge , more infants in study group 1 ( 46 % , n = 16 ) exhibited abnormal cranial measurements than those in study group 2 ( 19 % , n = 5 ) ( p = .03 ) .
-CONCLUSIONS	Rotating the cranial cup with the moldable positioner provides a feasible , safe , and potentially efficacious therapy for prevention of DP .
-
-###24813595
-OBJECTIVE	To determine the effect of cinnamon on menstrual cyclicity and metabolic dysfunction in women with polycystic ovary syndrome ( PCOS ) .
-METHODS	In a prospective , placebo controlled , double-blinded randomized trial , 45 women with PCOS were randomized ( 1:1 ) to receive cinnamon supplements ( 1.5 g/d ) or placebo for 6 months .
-METHODS	Menstrual cyclicity ( average cycles/month ) during the 6 months study period was compared between the 2 groups using the Mann-Whitney U test .
-METHODS	Changes in menstrual cyclicity and insulin resistance between baseline and the 6 month study period were compared between the 2 groups using Wilcoxon signed rank tests .
-RESULTS	The 45 women were randomized , 26 women completed 3 months of the study , and 17 women completed the entire 6 months of the study .
-RESULTS	During the 6 month intervention , menstrual cycles were more frequent in patients taking cinnamon compared with patients taking placebo ( median , 0.75 ; interquartile range , 0.5-0 .83 vs median , 0.25 ; interquartile range , 0-0 .54 ; P = .0085 ; Mann Whitney U ) .
-RESULTS	In patients taking cinnamon , menstrual cyclicity improved from baseline ( + 0.23 cycles/month 95 % confidence interval , 0.099-0 .36 ) , yet did not improve for women taking placebo .
-RESULTS	( P = .0076 , Wilcoxon signed rank ) .
-RESULTS	Samples ( n = 5 ) of serum from the luteal phase in different patients within the cinnamon group were thawed and ovulatory progesterone levels ( > 3 ng/mL ) confirmed .
-RESULTS	Luteal phase progesterone levels ( > 3 ng/mL , n = 5 ) confirmed ovulatory menses .
-RESULTS	Measures of insulin resistance or serum androgen levels did not change for either group .
-CONCLUSIONS	These preliminary data suggest that cinnamon supplementation improves menstrual cyclicity and may be an effective treatment option for some women with PCOS .
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-###24917213
-BACKGROUND	Many studies have indicated that the reduced folate carrier gene ( SLC19A1 ) is associated with an increased risk of neural tube defects ( NTDs ) .
-BACKGROUND	However , the interaction between the SLC19A1 gene variant and maternal fever exposure and NTD risk remains unknown .
-BACKGROUND	The aim of this study was to investigate whether the risk for NTDs was influenced by the interactions between the SLC19A1 ( rs1051266 ) variant and maternal first trimester fever .
-METHODS	We investigated the potential interaction between maternal first trimester fever and maternal or offspring SLC19A1 polymorphism through a population-based case-control study .
-METHODS	One hundred and four nuclear families with NTDs and 100 control families with nonmal newborns were included in the study .
-METHODS	SLC19A1 polymorphism was determined using polymerase chain reaction-restricted fragment length polymorphism .
-RESULTS	Mothers who had the GG/GA genotype and first trimester fever had an elevated risk of NTDs ( adjusted odds ratio , 11.73 ; 95 % confidence interval , 3.02-45 .58 ) as compared to absence of maternal first trimester fever and AA genotype after adjusting for maternal education , paternal education , and age , and had a significant interactive coefficient ( = 3.17 ) between maternal GG/GA genotype and first trimester fever .
-RESULTS	However , there was no interaction between offspring 's GG/GA genotype and maternal first trimester fever ( the interactive coefficient = 0.97 ) after adjusting for confounding factors .
-CONCLUSIONS	Our findings suggested that the risk of NTDs was potentially influenced by a gene-environment interaction between maternal SLC19A1 rs1051266 GG/GA genotype and first trimester fever .
-CONCLUSIONS	Maternal GG/GA genotype may strengthen the effect of maternal fever exposure on NTD risk in this Chinese population .
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-###25036218
-OBJECTIVE	The authors assess the long-term safety and efficacy of cervical disc replacement with the Prestige Cervical Disc in a prospective , randomized , multicenter trial at 7 years of follow-up .
-METHODS	At 31 investigational sites , 541 patients with single-level cervical disc disease with radiculopathy were randomized to 1 of 2 treatment groups : 276 investigational group patients underwent anterior cervical discectomy and arthroplasty with the Prestige disc , and 265 control group patients underwent anterior cervical discectomy and fusion .
-METHODS	Clinical outcomes included Neck Disability Index , the 36-Item Short-Form Health Survey , and neck and arm pain scores .
-METHODS	Radiographs were assessed for angle of motion and fusion .
-METHODS	Clinical and radiographic outcomes were evaluated preoperatively , intraoperatively , and at 1.5 , 3 , 6 , 12 , 24 , 36 , 60 , and 84 months .
-RESULTS	Of the 541 patients treated , 395 patients ( 73 % ; 212 investigational and 183 control patients ) completed 7 years of clinical follow-up .
-RESULTS	Significant improvements achieved by 1.5 months in both groups were sustained at 7 years .
-RESULTS	In the investigational group , mean Neck Disability Index improvements from preoperative scores were 38.2 and 37.5 at 60 and 84 months , respectively .
-RESULTS	In the control group , the corresponding means were 33.8 and 31.9 .
-RESULTS	The differences between the investigational and control groups at the 60-month and 84-month periods were significant ( p = 0.014 and 0.002 , respectively ) .
-RESULTS	The overall rates of maintenance or improvement in neurological status in the investigational group were significantly higher : 92.2 % and 88.2 % at 60 months and 84 months , respectively , compared with 85.7 % and 79.7 % in the control group ( p = 0.017 and 0.011 , respectively ) .
-RESULTS	At 84 months , the percentage of working patients in the investigational group was 73.9 % , and in the control group , 73.1 % .
-RESULTS	Postoperatively , the implant effectively maintained average angular motion of 6.67 at 60 months and 6.75 at 84 months .
-RESULTS	Cumulative rates for surgery at the index level were lower ( p < 0.001 ) in the investigational group ( 11 [ 4.8 % ] of 276 ) when compared with the control group ( 29 [ 13.7 % ] of 265 ) ( based on life-table method ) , and there were statistical differences between the investigational and control groups with specific regard to the rate of subsequent revision and supplemental fixation surgical procedures .
-RESULTS	Rates for additional surgical procedures that involved adjacent levels were lower in the investigational group than in the control group ( 11 [ 4.6 % ] of 276 vs. 24 [ 11.9 % ] of 265 , respectively ) .
-CONCLUSIONS	Cervical disc arthroplasty has the potential for preserving motion at the operated level while providing biomechanical stability and global neck mobility and may result in a reduction in adjacent-segment degeneration .
-CONCLUSIONS	The Prestige Cervical Disc maintains improved clinical outcomes and segmental motion after implantation at 7-year follow-up .
-CONCLUSIONS	Clinical trial registration no .
-CONCLUSIONS	NCT00642876 ( ClinicalTrials.gov ) .
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-###24749812
-BACKGROUND	In patients with moderate-to-severe psoriasis , health-related quality of life ( HRQOL ) has been shown to improve in parallel with improvement in disease severity .
-OBJECTIVE	To evaluate the role of pruritus ( itch ) in mediating the relationship between improvements in disease severity and HRQOL .
-METHODS	Data from a phase 2 clinical trial , in which 142 patients with moderate-to-severe plaque psoriasis received ixekizumab or placebo , were used for this posthoc analysis .
-METHODS	Relationships between improvement in Psoriasis Area and Severity Index ( PASI ) , Itch Visual Analogue Scale ( VAS ) and Dermatology Life Quality Index ( DLQI ) , as well as in individual DLQI domains ( symptoms and feelings , treatment , work and school , daily activities , leisure , and personal relationships ) from baseline to week 16 were determined .
-METHODS	Multiple hierarchical linear regressions and Sobel tests were conducted to evaluate the results .
-RESULTS	Improvement in PASI was highly correlated with pruritus improvement and improvements in DLQI total and domain scores at week 16 ( P < 001 ) .
-RESULTS	Multiple hierarchical linear regression analyses showed a statistically significant ( P < 001 ) association between improvement in pruritus and improvement in DLQI total score and each of the six DLQI domain scores after adjusting for improvement in PASI .
-RESULTS	Sobel tests indicated that pruritus had a significant mediation effect ( P < 005 ) on the association of PASI improvement with improvement in DLQI total score and all domains except the personal relationships score .
-CONCLUSIONS	Pruritus appears to be an important mediator of the association between improvements in disease severity and HRQOL in patients with moderate-to-severe psoriasis .
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-###24334183
-BACKGROUND	Individuals with HIV infection and peripheral metabolic complications have impaired basal myocardial insulin sensitivity that is related to left ventricular ( LV ) diastolic dysfunction .
-BACKGROUND	It is unknown whether interventions shown to be effective in improving peripheral insulin sensitivity can improve basal myocardial insulin sensitivity and diastolic function in people with HIV and peripheral metabolic complications .
-OBJECTIVE	In a pilot study , we evaluated whether the peroxisome proliferator-activated receptor-gamma ( PPAR - ) agonist pioglitazone or combined endurance and resistance exercise training improves basal myocardial insulin sensitivity and diastolic function in HIV + adults with peripheral metabolic complications .
-METHODS	Twenty-four HIV + adults with metabolic complications including peripheral insulin resistance were randomly assigned to 4 months of pioglitazone ( PIO ; 30 mg/d ) or supervised , progressive endurance and resistance exercise training ( EXS ; 90-120 min/d , 3 d/wk ) .
-METHODS	Basal myocardial substrate metabolism was quantified by radioisotope tracer methodology and positron emission tomography ( PET ) imaging , and LV function was measured by echocardiography .
-RESULTS	Twenty participants completed the study .
-RESULTS	Neither PIO nor EXS resulted in a detectable improvement in basal myocardial insulin sensitivity or diastolic function .
-RESULTS	Post hoc analyses revealed sample sizes of more than 100 participants are needed to detect significant effects of these interventions on basal myocardial insulin sensitivity and function .
-CONCLUSIONS	PIO or EXS alone did not significantly increase basal myocardial insulin sensitivity or LV diastolic function in HIV + individuals with peripheral metabolic complications .
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-###24276953
-OBJECTIVE	Aprepitant , an oral neurokinin-1 receptor antagonist , has demonstrated improved control of chemotherapy-induced nausea and vomiting ( CINV ) in previous studies .
-OBJECTIVE	This is the first phase III study to evaluate the efficacy and tolerability of aprepitant in patients receiving highly emetogenic chemotherapy ( HEC ) in Asian countries .
-METHODS	This multicenter , double-blind , placebo-controlled trial assessed the prevention of CINV during the acute phase ( AP ) , delayed phase ( DP ) , and overall phase ( OP ) .
-METHODS	Patients receiving HEC were randomized to either an aprepitant group ( day 1 , aprepitant 125 mg ; days 2-3 , aprepitant 80 mg ) or a standard therapy group ( days 1-3 , placebo ) .
-METHODS	Both groups received intravenous granisetron and oral dexamethasone .
-METHODS	The primary end point was complete response ( CR ; no emesis and no use of rescue therapy ) during the OP .
-RESULTS	Of the 421 randomized patients , 411 ( 98 % ) were assessable for efficacy ; 69.6 % ( 142/204 ) and 57.0 % ( 118/207 ) of patients reported CR during the OP in the aprepitant and standard therapy groups , respectively ( P = 0.007 ) .
-RESULTS	CR rates in the aprepitant group were higher during the DP ( 74.0 % vs. 59.4 % , P = 0.001 ) but were similar during the AP ( 79.4 % vs. 79.3 % , P = 0.942 ) .
-RESULTS	Toxicity and adverse events were comparable in both groups .
-CONCLUSIONS	The addition of aprepitant to standard antiemetic treatment regimens for Chinese patients undergoing HEC provided superior CINV prevention and was well tolerated .
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-###24326088
-BACKGROUND	The purpose of this study was to evaluate the effectiveness of mandibular advancement devices ( MADs ) for treatment of obstructive sleep apnea syndrome ( OSAS ) compared with the results obtained with a placebo device in accordance with the following indicators : apnea hypopnea index ( AHI ) per hour of sleep , apnea index ( AI ) per hour of sleep , mean oxyhemoglobin saturation , sleep efficiency , and percentage of rapid eye movement ( REM ) sleep .
-METHODS	This is a controlled , prospective longitudinal study with a follow-up time of 10.5 months .
-METHODS	Nineteen patients ( 8 females and 11 males ) with mean age 48.6 years ( SD 9.6 ) were selected for the study .
-METHODS	The sample was randomized in terms of device use , and the evaluation design was double blind .
-METHODS	A total of 57 polysomnography tests were studied ( at baseline , after the use of a MAD , and after the use of placebo ) .
-METHODS	The following variables were assessed : AHI , AI , mean oxyhemoglobin saturation , percentage of REM sleep , and sleep efficiency .
-METHODS	Wilcoxon and Mann-Whitney tests were used for evaluating data ( p < 0.05 ) .
-RESULTS	Reductions from 16.3 to 11.7 in AHI and from 5.7 to 3.8 in AI were observed after MAD use .
-RESULTS	During the use of placebo , AHI increased from 16.3 to 19.6 , and AI from 5.7 to 7.5 .
-RESULTS	The other indexes showed no statistically significant differences .
-CONCLUSIONS	Treatment with oral appliances , i.e. , MADs , can be an effective alternative for mild and medium-to-moderate OSAS , but requires strict monitoring due to differences in individual response to this therapy .
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-###25877855
-BACKGROUND	Angiogenesis is an important therapeutic target in colorectal carcinoma .
-BACKGROUND	Ramucirumab is a human IgG-1 monoclonal antibody that targets the extracellular domain of VEGF receptor 2 .
-BACKGROUND	We assessed the efficacy and safety of ramucirumab versus placebo in combination with second-line FOLFIRI ( leucovorin , fluorouracil , and irinotecan ) for metastatic colorectal cancer in patients with disease progression during or after first-line therapy with bevacizumab , oxaliplatin , and a fluoropyrimidine .
-METHODS	Between Dec 14 , 2010 , and Aug 23 , 2013 , we enrolled patients into the multicentre , randomised , double-blind , phase 3 RAISE trial .
-METHODS	Eligible patients had disease progression during or within 6 months of the last dose of first-line therapy .
-METHODS	Patients were randomised ( 1:1 ) via a centralised , interactive voice-response system to receive 8 mg/kg intravenous ramucirumab plus FOLFIRI or matching placebo plus FOLFIRI every 2 weeks until disease progression , unacceptable toxic effects , or death .
-METHODS	Randomisation was stratified by region , KRAS mutation status , and time to disease progression after starting first-line treatment .
-METHODS	The primary endpoint was overall survival in the intention-to-treat population .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01183780.ld
-RESULTS	We enrolled 1072 patients ( 536 in each group ) .
-RESULTS	Median overall survival was 133 months ( 95 % CI 124-145 ) for patients in the ramucirumab group versus 117 months ( 108-127 ) for the placebo group ( hazard ratio 0844 95 % CI 0730-0976 ; log-rank p = 00219 ) .
-RESULTS	Survival benefit was consistent across subgroups of patients who received ramucirumab plus FOLFIRI .
-RESULTS	Grade 3 or worse adverse events seen in more than 5 % of patients were neutropenia ( 203 [ 38 % ] of 529 patients in the ramucirumab group vs 123 [ 23 % ] of 528 in the placebo group , with febrile neutropenia incidence of 18 [ 3 % ] vs 13 [ 2 % ] ) , hypertension ( 59 [ 11 % ] vs 15 [ 3 % ] ) , diarrhoea ( 57 [ 11 % ] vs 51 [ 10 % ] ) , and fatigue ( 61 [ 12 % ] vs 41 [ 8 % ] ) .
-CONCLUSIONS	Ramucirumab plus FOLFIRI significantly improved overall survival compared with placebo plus FOLFIRI as second-line treatment for patients with metastatic colorectal carcinoma .
-CONCLUSIONS	No unexpected adverse events were identified and toxic effects were manageable .
-BACKGROUND	Eli Lilly .
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-###24534318
-OBJECTIVE	To investigate the effect of endotracheal intubation ( TT ) or the laryngeal mask airway ( LMA ) on the incidence of perioperative respiratory adverse events in children with upper respiratory tract infection undergo general anesthesia .
-METHODS	From November , 2006 to October , 2012 in the Zhuji People 's Hospital , 76 children with upper respiratory tract infection approved by hospital ethic committee were randomly divided into 2 groups : group I ( n = 36 ) , children were applied with endotracheal intubation during general anesthesia ( TT group ) , while groupII ( n = 40 ) , laryngeal mask airway were used ( LMA group ) .
-METHODS	Intraoperative mean arterial pressure ( MAP ) , hear rate ( HR ) , pulse oximetry ( SPO2 ) , and end-tidal carbon dioxide partial pressure ( P ETCO2 ) were recorded during the surgery .
-METHODS	The incidence of adverse events such as hypoxemia , fidgety , sore throat , and laryngospasm were evaluated in resuscitation room.We also assessed the pre - and postoperative symptoms of respiratory tract infection .
-RESULTS	There was no significant difference in upper respiratory tract infection symptoms between two groups , and the children in both groups have good tolerance to TT or LMA.However , the hemodynamics status in LMA group were more stable than those in TT group after the LMA insertion or removing ( P < 0.05 ) .
-RESULTS	The incidence of hypoxemia , fidgety , sore throat , and laryngospasm were significant lower in LMA group compared with those in TT group ( P < 0.05 ) .
-CONCLUSIONS	LMA could decrease the incidence of perioperative respiratory adverse events and can be safely used in children with upper respiratory tract infection undergo general anesthesia .
-
-###24909254
-BACKGROUND	This study compares the effectiveness of three treating methods including behavioral mother training ( BMT ) , Verbal self-instruction to the children ( VSI ) , and pharmacotherapy in children with attention deficit-hyperactivity disorder ( ADHD ) using the continuous performance test ( CPT ) .
-METHODS	In this semi-experimental study , 51 elementary students were identified in a boys ' school in Shiraz ( age 8-10 ) with attention deficit-hyperactivity disorder in a pilot study ( among 1760 students ) .
-METHODS	They were randomly divided into three groups ; BMT , VSI , and control group .
-METHODS	Moreover , 22 students were selected with ADHD among the clients in Hafez hospital .
-METHODS	They were chosen by the availability method and they were put into the Pharmacotherapy group .
-METHODS	Data collection tools were the Child Symptoms Inventory ( CSI-4 ) and the continuous performance test .
-METHODS	All of the groups were evaluated after the intervention and in post-test and also 2 months later in follow up .
-RESULTS	The treatment type ( group ) showed statistically significant difference in the result of CPT on severity of attention-deficit and in the number of correct responses ( P = 0.01 ) , yet on the hyperactivity symptoms , there was no significant difference between the different treatment groups ( P = 0.08 ) .
-RESULTS	The time factor shows a significant difference among the different groups ( p < 0.001 ) .
-CONCLUSIONS	Comparison of the various treatments of ADHD indicates that pharmacotherapy can improve the severity of attention deficit and the number of correct answers of children with ADHD .
-
-###24447187
-OBJECTIVE	Child pedestrian injury is a global public health challenge .
-OBJECTIVE	This randomized , controlled trial considered comparative efficacy of individualized streetside training , training in a virtual pedestrian environment , training using videos and Web sites , plus no-training control , to improve children 's street-crossing ability .
-METHODS	Pedestrian safety was evaluated among 231 7 - and 8-year-olds using both streetside ( field ) and laboratory-based ( virtual environment ) trials before intervention group assignment , immediately posttraining , and 6 months posttraining .
-METHODS	All training groups received 6 30-min sessions .
-METHODS	Four outcomes assessed pedestrian safety : start delay ( temporal lag before initiating crossing ) , hits/close calls ( collisions/near-misses with vehicles in simulated crossings ) , attention to traffic ( looks left and right , controlled for time ) , and missed opportunities ( safe crossing opportunities that were missed ) .
-RESULTS	Results showed training in the virtual pedestrian environment and especially individualized streetside training resulted in safer pedestrian behavior postintervention and at follow-up .
-RESULTS	As examples , children trained streetside entered safe traffic gaps more quickly posttraining than control group children and children trained streetside or in the virtual environment had somewhat fewer hits/close calls in postintervention VR trials .
-RESULTS	Children showed minimal change in attention to traffic posttraining .
-RESULTS	Children trained with videos/websites showed minimal learning .
-CONCLUSIONS	Both individualized streetside training and training within virtual pedestrian environments may improve 7 - and 8-year-olds ' street-crossing safety .
-CONCLUSIONS	Individualized training has limitations of adult time and labor .
-CONCLUSIONS	Virtual environment training has limitations of accessibility and cost .
-CONCLUSIONS	Given the public health burden of child pedestrian injuries , future research should explore innovative strategies for effective training that can be broadly disseminated .
-
-###24462523
-BACKGROUND	Biventricular ( BV ) electrical wavefront fusion can induce improvement in left ventricular ( LV ) size and function during cardiac resynchronization therapy ( CRT ) .
-BACKGROUND	Changes in BV wave propagation sequence and duration register in the QRS complex on the standard electrocardiogram .
-BACKGROUND	We developed a wave interference method for the characterization of BV fusion to predict LV reverse remodeling .
-OBJECTIVE	To develop a simple electrocardiographic method for predicting reverse remodeling during CRT .
-METHODS	QRS complexes during left bundle branch block ( LBBB ) and CRT were analyzed in 375 patients with ejection fraction 35 % and New York Heart Association class III-IV ( Leiden study : n = 226 ) as well as in patients with ejection fraction 40 % and New York Heart Association class I-II ( REVERSE trial : n = 149 ) for predictors of 10 % reduction in left ventricular end-systolic volume at 6 months .
-METHODS	CRT-induced changes in ventricular activation ( QRS fusion contour ) , electrical asynchrony ( QRS difference = BV-paced QRS - LBBB QRS , in milliseconds ) , and LBBB substrate ( LV activation time and QRS score for LV scar ) were quantified .
-RESULTS	Multivariable predictors of reverse remodeling were as follows : ( 1 ) either of 2 BV fusion patterns : QRS normalization in leads V1 and V2 ( n = 66 [ 18 % ] ; odds ratio [ OR ] 3.71 ; 95 % confidence interval [ CI ] 1.26-10 .94 ) or a new or an increased R wave in leads V1-V2 ( n = 267 [ 71 % ] ; OR 1.55 ; 95 % CI 0.65-3 .65 ) ; ( 2 ) QRS difference -25 ms ( OR 2.35 ; 95 % CI 1.12-4 .91 ) ; and ( 3 ) good substrate ( low to moderate QRS score and LV activation time 110 ms ; OR 2.94 ; 95 % CI 1.68-5 .14 ) .
-RESULTS	Remodeling rates were 40 % for poor substrate and persistent LBBB QRS complex ( absent BV fusion ; QRS type 3 : n = 42 [ 11 % ] ) and 97 % for the best BV QRS fusion pattern and greater reduction in electrical asynchrony ( larger QRS difference ) .
-CONCLUSIONS	Easily determined QRS complex attributes before and after CRT predict LV reverse remodeling .
-
-###24811050
-BACKGROUND	The aim of this study was to compare the efficacy and safety of micropulse and continuous wave diode transscleral cyclophotocoagulation in refractory glaucoma .
-METHODS	Randomized , comparative , exploratory study in a tertiary hospital setting .
-METHODS	Patients with refractory , end-stage glaucoma .
-METHODS	Forty-eight patients were randomized to either treatment .
-METHODS	The intraocular pressure , visual acuity , number of medicines and repeat treatment were monitored for 18 months .
-METHODS	Complications that include visual acuity decline , prolonged anterior chamber inflammation , phthisis bulbi , scleral thinning and ocular pain were noted .
-METHODS	Intraocular pressure between 6 and 21mmHg and at least a 30 % reduction with or without anti-glaucoma medications after 18 months .
-RESULTS	A successful primary outcome was achieved in 75 % of patients who underwent micropulse cyclophotocoagulation and 29 % of patients who received continuous wave cyclophotocoagulation after 12 months ( P < 0.01 ) .
-RESULTS	At 18 months , successful outcome was 52 % and 30 % ( P = 0.13 ) , respectively .
-RESULTS	The mean intraocular pressure was reduced by 45 % in both groups ( P = 0.70 ) from a baseline of 36.5 mmHg and 35.0 mmHg ( P = 0.50 ) after 17.51.6 months ( range 16-19 ) follow up .
-RESULTS	No significant difference in retreatment rates or number of intraocular pressure lowering medications was noted .
-RESULTS	The ocular complication rate was higher in continuous wave treated eyes ( P = 0.01 ) .
-CONCLUSIONS	Diode transscleral cyclophotocoagulation in both micropulse and continuous modes was effective in lowering intraocular pressure .
-CONCLUSIONS	The micropulse mode provided a more consistent and predictable effect in lowering intraocular pressure with minimal ocular complications .
-
-###25948515
-BACKGROUND	The effectiveness of extracorporeal shock wave therapy in the treatment of plantar fasciitis is controversial .
-BACKGROUND	The objective of the present study was to test whether focused extracorporeal shock wave therapy is effective in relieving chronic heel pain diagnosed as plantar fasciitis .
-METHODS	Two hundred and fifty subjects were enrolled in a prospective , multicenter , double-blind , randomized , and placebo-controlled U.S. Food and Drug Administration trial .
-METHODS	Subjects were randomized to focused extracorporeal shock wave therapy ( 0.25 mJ/mm ( 2 ) ) or placebo intervention , with three sessions of 2000 impulses in weekly intervals .
-METHODS	Primary outcomes were both the percentage change of heel pain on the visual analog scale composite score ( pain during first steps in the morning , pain with daily activities , and pain with a force meter ) and the Roles and Maudsley score at twelve weeks after the last intervention compared with the scores at baseline .
-RESULTS	Two hundred and forty-six patients ( 98.4 % ) were available for intention-to-treat analysis at the twelve-week follow-up .
-RESULTS	With regard to the first primary end point , the visual analog scale composite score , there was a significant difference ( p = 0.0027 , one-sided ) in the reduction of heel pain in the extracorporeal shock wave therapy group ( 69.2 % ) compared with the placebo therapy group ( 34.5 % ) .
-RESULTS	Extracorporeal shock wave therapy was also significantly superior to the placebo therapy for the Roles and Maudsley score ( p = 0.0006 , one-sided ) .
-RESULTS	Temporary pain and swelling during and after treatment were the only device-related adverse events observed .
-CONCLUSIONS	The results of the present study provide proof of the clinically relevant effect size of focused extracorporeal shock wave therapy without local anesthesia in the treatment of recalcitrant plantar fasciitis , with success rates between 50 % and 65 % .
-METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .
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-###24647726
-OBJECTIVE	Relapse is highly prevalent following substance abuse treatments , highlighting the need for improved aftercare interventions .
-OBJECTIVE	Mindfulness-based relapse prevention ( MBRP ) , a group-based psychosocial aftercare , integrates evidence-based practices from mindfulness-based interventions and cognitive-behavioral relapse prevention ( RP ) approaches .
-OBJECTIVE	To evaluate the long-term efficacy of MBRP in reducing relapse compared with RP and treatment as usual ( TAU [ 12-step programming and psychoeducation ] ) during a 12-month follow-up period .
-METHODS	Between October 2009 and July 2012 , a total of 286 eligible individuals who successfully completed initial treatment for substance use disorders at a private , nonprofit treatment facility were randomized to MBRP , RP , or TAU aftercare and monitored for 12 months .
-METHODS	Participants medically cleared for continuing care were aged 18 to 70 years ; 71.5 % were male and 42.1 % were of ethnic/racial minority .
-METHODS	Participants were randomly assigned to 8 weekly group sessions of MBRP , cognitive-behavioral RP , or TAU .
-METHODS	Primary outcomes included relapse to drug use and heavy drinking as well as frequency of substance use in the past 90 days .
-METHODS	Variables were assessed at baseline and at 3 - , 6 - , and 12-month follow-up points .
-METHODS	Measures used included self-report of relapse and urinalysis drug and alcohol screenings .
-RESULTS	Compared with TAU , participants assigned to MBRP and RP reported significantly lower risk of relapse to substance use and heavy drinking and , among those who used substances , significantly fewer days of substance use and heavy drinking at the 6-month follow-up .
-RESULTS	Cognitive-behavioral RP showed an advantage over MBRP in time to first drug use .
-RESULTS	At the 12-month follow-up , MBRP participants reported significantly fewer days of substance use and significantly decreased heavy drinking compared with RP and TAU .
-CONCLUSIONS	For individuals in aftercare following initial treatment for substance use disorders , RP and MBRP , compared with TAU , produced significantly reduced relapse risk to drug use and heavy drinking .
-CONCLUSIONS	Relapse prevention delayed time to first drug use at 6-month follow-up , with MBRP and RP participants who used alcohol also reporting significantly fewer heavy drinking days compared with TAU participants .
-CONCLUSIONS	At 12-month follow-up , MBRP offered added benefit over RP and TAU in reducing drug use and heavy drinking .
-CONCLUSIONS	Targeted mindfulness practices may support long-term outcomes by strengthening the ability to monitor and skillfully cope with discomfort associated with craving or negative affect , thus supporting long-term outcomes .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01159535
-
-###25294839
-BACKGROUND	whole-body vibration training may improve neuromuscular function , falls risk and bone density , but previous studies have had conflicting findings .
-OBJECTIVE	this study aimed to evaluate the influence of vertical vibration ( VV ) and side-alternating vibration ( SV ) on musculoskeletal health in older people at risk of falls .
-METHODS	single-blind , randomised , controlled trial comparing vibration training to sham vibration ( Sham ) in addition to usual care .
-METHODS	participants were 61 older people ( 37 women and 24 men ) , aged 80.2 + 6.5 years , referred to an outpatient falls prevention service .
-METHODS	participants were randomly assigned to VV , SV or Sham in addition to the usual falls prevention programme .
-METHODS	Participants were requested to attend three vibration sessions per week for 12 weeks , with sessions increasing to six , 1 min bouts of vibration .
-METHODS	Falls risk factors and neuromuscular tests were assessed , and blood samples collected for determination of bone turnover , at baseline and following the intervention .
-RESULTS	chair stand time , timed-up-and-go time , fear of falling , NEADL index and postural sway with eyes open improved in the Sham group .
-RESULTS	There were significantly greater gains in leg power in the VV than in the Sham group and in bone formation in SV and VV compared with the Sham group .
-RESULTS	Conversely , body sway improved less in the VV than in the Sham group .
-RESULTS	Changes in falls risk factors did not differ between the groups .
-CONCLUSIONS	whole-body vibration increased leg power and bone formation , but it did not provide any additional benefits to balance or fall risk factors beyond a falls prevention programme in older people at risk of falls .
-
-###24460280
-BACKGROUND	To determine whether the Health Partner Program is effective in training long-term cancer survivors to be health coaches .
-METHODS	We randomly assigned cancer survivors who were selected through a rigorous screening process to either the Health Partner Program or the waiting-list control group .
-METHODS	The program consisted of 8 weeks of training in health management , leadership , and coaching .
-METHODS	At baseline , 8 , and 16 weeks , we measured primary outcomes using the Seven Habit Profile ( SHP ) , the Korean Leadership Coaching Competency Inventory ( KCCI ) , Ed Diner 's Satisfaction with Life Scale ( SWLS ) , and the Posttraumatic Growth inventory ( PTGI ) and secondary outcomes using the Hospital Anxiety and Depression Scale ( HADS ) , the Impact of Event Scale-Revised ( IES-R ) , and the Medical Outcomes Study ( MOS ) short form 36-item questionnaire ( SF - 36 ) .
-RESULTS	We recruited 70 subjects and randomly assigned 34 to the intervention group .
-RESULTS	The Sharpen the Saw habit of the SHP increased significantly more in intervention group than in the control group ( p = 0.049 ) , as did most PTGI factors .
-RESULTS	The intervention group also showed a significantly greater enhancement of vitality ( p = 0.015 ) and mental health ( p = 0.049 ) SF-36 scores but no improvement in KCCI , SWLS , HADS , or IES-R scores .
-RESULTS	The intervention group also showed a greater clinically meaningful improvement in the `` Think Win-Win '' of SHP ( p = 0.043 ) and in the personal strength score ( p = 0.025 ) and total score ( p = 0.015 ) of the PTGI .
-CONCLUSIONS	Long-term cancer survivors can benefit from the Health Partner Program to become health coaches .
-
-###24264551
-OBJECTIVE	The aim of this study was to investigate the effect of gabapentin premedication on postoperative 24th hour total analgesic consumption and the incidence of emergence agitation after sevoflurane based anesthesia in pediatric patients undergoingtonsillectomyandadenoidectomy .
-METHODS	46 healthy , ASA class I or II , aged 3-12 year old children were included into the study .
-METHODS	The patients were randomly assigned to one of the control ( Group C ) or gabapentin group ( Group G ) consisting of 23 patients in each .
-METHODS	Group C received 10 ml of saline , Group G received gabapentin 15 mg.kg-1 dissolved in 10 ml of saline orally 30 min .
-METHODS	before the induction of anesthesia .
-METHODS	After anesthesia induction with 8 % sevoflurane in 50 % O2-N2O .
-METHODS	General anesthesia was maintained with 1 MAC sevoflurane in 50 % O2-N2O .
-METHODS	Emergence agitation was assessed with a 5 point scale and recorded every 10 min .
-METHODS	of first 30 min .
-METHODS	of the postoperative period .
-METHODS	Parents were contacted 24 hours after the surgery to evaluate pain , total analgesic consumption , parent satisfactionandanysideeffect .
-RESULTS	Agitation scores were significantly lower in group G compared to group C in the postoperative 20th and 30th minutes ( p < 0.01 , 0.05 respectively ) .
-RESULTS	Total analgesic requirement in postoperative 24 hour was significantly lower in group G ( p < 0.01 ) .
-RESULTS	Satisfaction scores of parents was also higher in group G ( p < 0.05 ) .
-CONCLUSIONS	Gabapentin premedication decreases postoperative 24th hour analgesic consumption and attenuates emergence agitation after sevoflurane anesthesia .
-
-###24587571
-OBJECTIVE	To evaluate next-morning driving performance after middle-of-the-night use of zolpidem 3.5 mg in a buffered sublingual formulation ( ZST ) .
-METHODS	Single-center , four-period , randomized , double-blind , placebo-controlled , crossover study .
-METHODS	Maastricht University , The Netherlands .
-METHODS	Forty healthy volunteers ( 20 females ) .
-METHODS	Single dose of ZST administered in the middle of the night at 3 and 4 h before driving , zopiclone 7.5 mg at bedtime 9 h before driving , and placebo .
-METHODS	Performance in a 100-km standardized highway driving test in normal traffic measuring standard deviation of lateral position ( SDLP ) - an index of weaving .
-METHODS	Drug-placebo changes in SDLP > 2.5 cm were considered to reflect clinically relevant driving impairment .
-RESULTS	For ZST , Max McNemar symmetry analyses showed that the proportion of drivers classified as impaired was increased 3 h after dosing ( P < 0.012 ) , but not 4 h after dosing .
-RESULTS	Mean increases in SDLP from placebo , although statistically significant , were small ( 1.46 cm [ P < 0.0001 ] at 3 h and 0.83 cm [ P = 0.0174 ] at 4 h ) .
-RESULTS	The morning after zopiclone , 45 % of the drivers were classified as impaired with a mean increase in SDLP of 2.46 cm ( P < 0.0001 ) .
-RESULTS	There were no significant sex differences in effects of ZST and zopiclone .
-CONCLUSIONS	Zolpidem 3.5 mg in a buffered sublingual formulation has a minimal risk of impairing driving performance in the morning 4 hours after middle-of-the night use .
-CONCLUSIONS	When taken 3 hours before driving , the drug may have impairing effects so caution should be exercised if medication is taken other than as indicated .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT01106859 ; Trial Name : Driving Performance After Middle of the Night Administration of 3.5 mg Zolpidem Tartrate Sublingual Tablet ; http://clinicaltrials.gov/ct2/show/NCT01106859 .
-
-###24903663
-BACKGROUND	Pneumonia is the leading cause of childhood mortality globally .
-BACKGROUND	Respiratory syncytial virus ( RSV ) is the most important viral cause of pneumonia .
-BACKGROUND	Maternal serum antibody protects infants from RSV disease .
-BACKGROUND	The objective of our study was to characterize RSV antibody levels in mother-infant pairs .
-METHODS	Serial serum samples were collected from mother-infant pairs in Bangladesh from the third trimester of pregnancy to 72 weeks postpartum and tested using an RSV antibody microneutralization assay .
-METHODS	Serologic infection was defined as a 4-fold increase in antibody titer .
-METHODS	Maternal antibody half-life was calculated using infant antibody titers from birth to 20 weeks .
-RESULTS	The ratio of infant cord blood to maternal serum RSV antibody titers in 149 mother-infant pairs was 1.01 ( 95 % confidence interval [ CI ] , .99 -1.03 ) .
-RESULTS	Maternal RSV antibody titers in the third trimester and at birth were strongly correlated ( R = 0.68 ) .
-RESULTS	Antibody half-life was 38 days ( 95 % CI , 36-42 days ) .
-RESULTS	Higher cord blood RSV antibody titers were associated with a lower risk of serologic infection ( P = .01 ) and maintenance of antibody titer above a potentially protective threshold ( P < .001 ) .
-CONCLUSIONS	Efficient transplacental transfer of RSV-specific antibody from mother to the fetus was documented in mother-infant pairs in Asia .
-CONCLUSIONS	Higher cord blood antibody titers were associated with protection from serologic infection .
-
-###24588298
-BACKGROUND	Although women with substance use disorders ( SUDs ) have high rates of trauma and posttraumatic stress , many addiction programs do not offer trauma-specific treatments .
-BACKGROUND	One promising intervention is Pennebaker 's expressive writing , which involves daily , 20-minute writing sessions to facilitate disclosure of stressful experiences .
-METHODS	Women ( N = 149 ) in residential treatment completed a randomized clinical trial comparing expressive writing with control writing .
-METHODS	Repeated-measures analysis of variance was used to document change in psychological and physical distress from baseline to 2-week and 1-month follow-ups .
-METHODS	Analyses also examined immediate levels of negative affect following expressive writing .
-RESULTS	Expressive writing participants showed greater reductions in posttraumatic symptom severity , depression , and anxiety scores , when compared with control writing participants at the 2-week follow-up .
-RESULTS	No group differences were found at the 1-month follow-up .
-RESULTS	Safety data were encouraging : although expressive writing participants showed increased negative affect immediately after each writing session , there were no differences in pre-writing negative affect scores between conditions the following day .
-RESULTS	By the final writing session , participants were able to write about traumatic/stressful events without having a spike in negative affect .
-CONCLUSIONS	Results suggest that expressive writing may be a brief , safe , low-cost , adjunct to SUD treatment that warrants further study as a strategy for addressing posttraumatic distress in substance-abusing women .
-
-###25987260
-BACKGROUND	Low serum bicarbonate level has been reported to be an independent predictor of kidney function decline and mortality in patients with chronic kidney disease .
-BACKGROUND	Mechanisms underlying low serum bicarbonate levels may differ in patients with and without diabetes .
-BACKGROUND	We aimed to specifically investigate the association of serum bicarbonate level with kidney disease progression and cardiovascular outcome in a cohort of patients with type 2 diabetes and nephropathy .
-METHODS	Post hoc analysis of 2 multicenter randomized controlled trials .
-METHODS	2,628 adults with type 2 diabetes and nephropathy .
-METHODS	Serum bicarbonate level .
-RESULTS	Incidence of : ( 1 ) end-stage renal disease ( ESRD ) , ( 2 ) ESRD or doubling of serum creatinine level , ( 3 ) all-cause mortality , ( 4 ) cardiovascular events ( fatal/nonfatal stroke/myocardial infarction ) , and ( 5 ) heart failure .
-METHODS	Serum bicarbonate was measured at baseline as total carbon dioxide .
-METHODS	Associations of baseline serum bicarbonate level with end points were investigated using Cox regression models .
-METHODS	Serum bicarbonate levels were studied as a continuous variable and stratified in quartiles .
-METHODS	Follow-up was 2.81.0 ( SD ) years .
-RESULTS	Cox regression analyses showed that serum bicarbonate level had inverse associations with incident ESRD ( HR , 0.91 ; 95 % CI , 0.89-0 .93 ; P < 0.001 ) and incidence of the combined end point of ESRD or serum creatinine doubling ( HR , 0.94 ; 95 % CI , 0.92-0 .96 ; P < 0.001 ) .
-RESULTS	These associations were independent of age , sex , and cardiovascular risk factors , but disappeared after adjustment for baseline estimated glomerular filtration rate ( all P > 0.05 ) .
-RESULTS	Analysis of bicarbonate quartiles showed similar results for the quartile with the lowest bicarbonate ( 21 mEq/L ) versus the quartile with normal bicarbonate levels ( 24-26 mEq/L ) .
-RESULTS	There was no association of bicarbonate level with cardiovascular events and heart failure .
-CONCLUSIONS	Post hoc analysis and single measurement of serum bicarbonate .
-CONCLUSIONS	In this cohort of patients with type 2 diabetes with nephropathy , serum bicarbonate level associations with kidney disease end points were not retained after adjustment for estimated glomerular filtration rate , which is in contrast to results of earlier studies in nondiabetic populations .
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-###25205062
-BACKGROUND	Barbed suture material offers the possibility of knotless flexor tendon repair , as suggested in an increasing number of biomechanical studies .
-BACKGROUND	There are currently two different absorbable barbed suture products available , V-Loc and Stratafix , and both have not been compared to each other with regard to flexor tendon repair .
-BACKGROUND	The purpose of this study was to evaluate both suture materials for primary stability under static and cyclic loading in a biomechanical ex vivo model .
-METHODS	Forty fresh porcine flexor digitorum profundus tendons were randomized in two groups .
-METHODS	A four-strand modified Kessler suture technique was used to repair the tendon either with a 3-0 V-Loc or 3-0 Stratafix without a knot .
-METHODS	Parameters of interest were mode of failure , 2-mm gap formation force , displacement , stiffness and maximum load under static and cyclic testing .
-RESULTS	The maximum load was 42.37.2 for the Stratafix group and 50.78.8 N for the V-Loc group .
-RESULTS	Thus , the ultimate tensile strength was significantly higher for V-Loc ( p < 0.05 ) .
-RESULTS	The 2-mm gap occurred at 24.82.04 N in the Stratafix group in comparison to 26.52.12 N in the V-Loc group ( n.s. ) .
-RESULTS	Displacement was 2.650.56 mm in the V-Loc group and 2.710.59 mm in the Stratafix group ( n.s. ) .
-RESULTS	Stiffness was 4.240.68 ( N/mm ) in the V-Loc group and 3.850.55 ( N/mm ) the Stratafix group ( n.s. ) .
-RESULTS	Those measured differences were not significant .
-CONCLUSIONS	V-Loc demonstrates a higher maximum load in tendon reconstruction .
-CONCLUSIONS	The differences in 2-mm gap formation force , displacement and stiffness were not significant .
-CONCLUSIONS	Hereby , the V-Loc has an advantage when used as unidirectional barbed suture for knotless flexor tendon repair .
-
-###26088573
-OBJECTIVE	Collateral artery growth ( arteriogenesis ) is an important adaptive response to hampered arterial perfusion .
-OBJECTIVE	It is unknown whether preventive physical exercise before limb ischemia can improve arteriogenesis and modulate mononuclear cell function .
-OBJECTIVE	This study aimed at investigating the effects of endurance exercise before arterial occlusion on MNC function and collateral artery growth .
-RESULTS	After 3 weeks of voluntary treadmill exercise , ligation of the right femoral artery was performed in mice .
-RESULTS	Hindlimb perfusion immediately after surgery did not differ from sedentary mice .
-RESULTS	However , previous exercise improved perfusion restoration 7 days after femoral artery ligation , also when exercise was stopped at ligation .
-RESULTS	This was accompanied by an accumulation of peri-collateral macrophages and increased expression of endothelial nitric oxide synthase and inducible nitric oxide synthase ( iNOS ) in hindlimb collateral and in MNC of blood and spleen .
-RESULTS	Systemic monocyte and macrophage depletion by liposomal clodronate but not splenectomy attenuated exercise-induced perfusion restoration , collateral artery growth , peri-collateral macrophage accumulation , and upregulation of iNOS .
-RESULTS	iNOS-deficient mice did not show exercise-induced perfusion restoration .
-RESULTS	Transplantation of bone marrow-derived MNC from iNOS-deficient mice into wild-type animals inhibited exercise-induced collateral artery growth .
-RESULTS	In contrast to sedentary controls , thrice weekly aerobic exercise training for 6 months in humans increased peripheral blood MNC iNOS expression .
-CONCLUSIONS	Circulating mononuclear cell-derived inducible nitric oxide is an important mediator of exercise-induced collateral artery growth .
-
-###24679880
-OBJECTIVE	We prospectively evaluated the efficacy of dissolution therapy and standard shock wave lithotripsy as a noninvasive modality for radiolucent renal stones in children .
-METHODS	A total of 87 children with radiolucent renal calculi were included in study .
-METHODS	Median age was 2.5 years ( range 0.5 to 13 ) .
-METHODS	Computerized tomography was done to confirm a stone density of less than 500 HU .
-METHODS	Median stone length was 12 mm ( range 7 to 24 ) .
-METHODS	Patients were randomly divided into 2 groups .
-METHODS	The medical group of 48 patients received potassium sodium hydrogen citrate at a dose of 1 mEq/kg per day for 1 to 3 months .
-METHODS	The shock wave lithotripsy group of 39 patients were treated with a Lithotripter S ( Dornier Medtech , Kennesaw , Georgia ) while under general anesthesia .
-METHODS	Complications in each group were recorded .
-METHODS	Patients were considered stone free when imaging within 3 months showed no evidence of stones .
-RESULTS	The stone-free rate was 72.9 % for dissolution therapy vs 82.1 % after a single session of shock wave lithotripsy ( p = 0.314 ) .
-RESULTS	One patient per group experienced a pyelonephritis episode during followup ( p = 0.698 ) .
-RESULTS	Three of the 13 patients in whom medical regimens failed were noncompliant and 5 ingested the medication sporadically .
-CONCLUSIONS	Medical dissolution therapy is a well tolerated , effective treatment for radiolucent renal stones in children .
-CONCLUSIONS	It eliminates the need for shock wave lithotripsy in up to 73 % of cases .
-
-###25112302
-BACKGROUND	The management of patients suffering from opioid-refractory cancer pain with a neuropathic component remains an important challenge for healthcare workers .
-BACKGROUND	Only one retrospective study specifically reported the use of intravenous ( IV ) lidocaine amongst the palliative care unit population , the study found that there was a positive response to this therapy .
-BACKGROUND	These preliminary uncontrolled results need to be confirmed by randomized controlled trials .
-BACKGROUND	The primary objective of this study is to assess the analgesic efficacy of IV lidocaine in patients in palliative care suffering from opioid-refractory cancer pain with a neuropathic component .
-BACKGROUND	The secondary objectives are to assess the tolerance of , symptomatology , and patient satisfaction with the therapeutic approach .
-METHODS	This will be a multicenter , prospective , randomized , placebo-controlled , double-blind , two-parallel group study .
-METHODS	It will take place in eight adult palliative care units across France .
-METHODS	The main inclusion criteria are as follows : adult patients suffering from opioid-refractory cancer pain with a neuropathic component , and those receiving palliative care as defined by French Society of Palliative and Support Care .
-METHODS	Participants will be randomized ( 1:1 allocation ratio ) to one of two treatment groups : a ) lidocaine-experimental group ( intravenous lidocaine ) , or b ) placebo-control group ( intravenous saline solution ) .
-METHODS	Evaluation assessments will be taken at baseline ( T0 randomization ) , 40 minutes ( T1 ) , 120 minutes ( T2 ) , 12 hours ( T3 ) , 24 hours ( T4 ) , 48 hours ( T5 ) , and 14 days ( T6 ) after baseline .
-METHODS	The primary endpoint is change in the pain level between T0 and T1 .
-METHODS	The secondary endpoints are : changes in the pain level between T0 and other times , intensity of the neuropathic pain component , daily opioid consumption , symptoms ( as classified by the MD Anderson Symptom Inventory ) , adverse events , and patient 's satisfaction ( measured using the Pain Treatment Satisfaction Scale ) .
-METHODS	A sample size of 200 individuals will be needed to obtain 90 % power to detect a 25 % difference in pain success at T1 between the two groups ; pain success is classified as a 30 % decrease in the pain level between T0 and T1 ( 10 % of patients lost to follow-up expected ) .
-CONCLUSIONS	The randomized , double-blind , placebo-controlled design is the most appropriate design to demonstrate the efficacy of a new experimental intervention ( Evidence-Based Medicine Working Group classification ) .
-CONCLUSIONS	National and international recommendations could be updated based on the findings of this study .
-BACKGROUND	Current controlled trials NCT02137954 ( registration date : 7 May 2014 ) .
-
-###24983687
-OBJECTIVE	Pelvic organ prolapse ( POP ) is a common and distressing condition .
-OBJECTIVE	The aim of the present study was to evaluate the effect ofpelvic floor muscle training ( PFMT ) on prevention and treatment ofsymptoms and signs of POP in primiparous postpartum women .
-METHODS	This was a parallel group assessor blind randomized controlled trial .
-METHODS	One hundred seventy-five primiparous postpartum women , mean age 29.8 years ( standard deviation 4.1 ) , stratified on major levator ani defects or no defect diagnosed by 3 - / 4-dimensional ultrasound , participated in a 4-month PFMT starting at 6-8 weeks ' postpartum or control .
-METHODS	All participants had thorough individual instruction and assessment of ability to perform correct pelvic floor muscle contractions .
-METHODS	The PFMT group followed a supervised , weekly group training program and performed 3 sets of 8-12 daily maximal contractions at home .
-METHODS	Main outcome was POP stage II or greater assessed by POP quantification and bladder neck position assessed by 3 - / 4 - dimensional transperineal ultrasonography .
-METHODS	Secondary outcome was symptoms of vaginal bulge using International Consultation on Incontinence Vaginal Symptoms questionnaire .
-RESULTS	Ninety-six percent of the intervention group adhered to 80 % of both group and home training sessions .
-RESULTS	At postintervention , there was no significant risk difference in POP ( rational ratio , 1.62 ; 95 % confidence interval , 0.55-4 .75 ) , bladder neck position or symptoms of vaginal bulging .
-CONCLUSIONS	No effect was found of postpartum PFMT on POP in primiparous women .
-CONCLUSIONS	More randomized controlled trials are needed before strong conclusions can be drawn on the effect of PFMT on POP in the particular population .
-
-###25376160
-OBJECTIVE	To investigate the efficacy , safety , and clinical benefit of prolonged-release trazodone ( Trittico ) in the treatment of major depressive disorder ( MDD ) .
-METHODS	In this study , 363 Chinese patients with MDD were randomized 1:1 to receive either prolonged-release trazodone ( 150-450 mg ) or placebo treatment for 6 weeks .
-METHODS	The primary efficacy measurement was the change of the 17-item Hamilton Depression Rating Scale ( HAMD-17 ) total score from baseline to the end of the study .
-METHODS	The secondary efficacy measurements were the response and remission rates , the Clinical Global Impression - Improvement of Illness ( CGI-I ) score at the end of the study , and the change of the HAMD-14 total score and quality of sleep [ evaluated by the Pittsburgh Sleep Quality Index ( PSQI ) scale ] during the study period .
-RESULTS	The mean maximum daily dose was 273.11 mg for the trazodone group and 290.92 mg for the placebo group .
-RESULTS	At the end of the study , there was a significant difference between the two groups in the HAMD-17 change score ( trazodone vs. placebo : -11.07 vs. -8.29 , p < 0.001 ) .
-RESULTS	Trazodone showed advantages at 1 week of treatment , and the effect lasted until the end of the study ( week 6 ) .
-RESULTS	The response and remission rates of the trazodone group were significantly higher than those in the placebo group ( response rate : 59.6 vs. 37.2 % , p < 0.001 ; remission rate : 35.5 vs. 22.2 % , p = 0.005 ) .
-RESULTS	The majority of the adverse reactions of trazodone were mild to moderate , and the most frequent adverse reactions ( 5 % ) were dizziness , dry mouth , somnolence , and nausea .
-CONCLUSIONS	Prolonged-release trazodone was more effective than placebo in MDD and was well tolerated .
-
-###25143061
-BACKGROUND	Psoriasis is a common skin disease with extensive comorbidity risks , which may affect multiple aspects of life .
-BACKGROUND	Self-management is essential for skin treatment and lifestyle choices , but few disease-specific tailored self-management and educational programmes appear to be available .
-OBJECTIVE	To evaluate the effects of a 3-month individual motivational interviewing intervention in patients with psoriasis ( with a total follow-up of 6 months ) after climate therapy/heliotherapy ( CHT ) .
-METHODS	A randomized controlled trial with 169 patients with psoriasis was conducted in the context of CHT at Gran Canaria , Spain .
-METHODS	The main outcome measures were Self-Administered Psoriasis Area and Severity Index ( SAPASI ) and Health Education Impact Questionnaire ( heiQ ) , and the secondary outcomes were illness perception , psoriasis knowledge and lifestyle change assessments .
-METHODS	Outcomes were measured at baseline , after 3 weeks of CHT , and 3 months and 6 months later .
-RESULTS	There were significant overall treatment effects in the study group in terms of the SAPASI score , three self-management domains of heiQ and the self-efficacy scores ( P < 005 ) .
-RESULTS	The lifestyle change parameters were significantly better in the study group .
-RESULTS	Illness perception differed between the groups at 3 months ( P = 0014 ) , and psoriasis knowledge was significantly better in the study group at 6 months ( P = 0017 ) .
-CONCLUSIONS	A 3-month motivational interviewing intervention following CHT had positive overall effects on disease severity , self-efficacy , psoriasis knowledge and health behaviour change .
-CONCLUSIONS	This approach has the potential to be an important complement to medical management , self-management and education in patients with psoriasis .
-
-###24628736
-BACKGROUND	Stopwatch-assessed duration of erection has been proposed as an objective and reliable efficacy end point for erectile dysfunction ( ED ) treatments .
-OBJECTIVE	The aim of this study is to assess vardenafil orodispersible tablets ' ( ODTs ) efficacy in terms of duration of erection and ( i ) its correlation with other efficacy end points and male and female sexual quality of life ( QoL ) and ( ii ) its impact on intercourse duration .
-METHODS	Randomized , double-blind , placebo-controlled , multicenter study comparing the efficacy and safety of vardenafil ODT 10mg on-demand over 12 weeks in 127 patients with ED was carried out .
-METHODS	Primary efficacy end points were stopwatch-assessed duration of erection ( min ) at any attempt and when leading to successful intercourse , and the erectile function domain of the International Index of Erectile Function ( EF-IIEF ) score .
-METHODS	Secondary end points were sexual encounter profile ( SEP ) 3 response rate and male sexual QoL .
-METHODS	End points in participating women ( N = 46 ) were stopwatch-assessed duration of intercourse and sexual QoL .
-RESULTS	At week 12/last observation carried forward , patients taking vardenafil ODT had longer duration of erections ( at any attempt or leading to successful intercourse ) vs. placebo ( least square meanstandard error 10.20.9 minutes vs. 7.91.0 minutes , and 10.40.8 vs. 8.31.0 minutes , respectively ) , and significant increases in EF-IIEF scores , the SEP-3 response , and all sexual QoL items .
-RESULTS	An increased duration of intercourse was also observed .
-RESULTS	Female sexual QoL improved significantly .
-RESULTS	Both duration end points strongly correlated with EF-IIEF scores , and the three end points correlated well with SEP-3 response .
-RESULTS	Correlation was good with sexual QoL scores in men and women and with duration of intercourse , with differences between treatment groups only for duration end points .
-RESULTS	Safety was similar in both groups .
-CONCLUSIONS	This study provides further evidence for the consistency and reliability of the stopwatch-assessed duration of erection as an efficacy end point for ED treatments , with `` duration of erection leading to successful intercourse '' showing better properties than duration at any attempt .
-
-###24886671
-BACKGROUND	Health-related quality of life ( QoL ) has prognostic value in many cancers .
-BACKGROUND	A recent study found that the performance of prognostic systems for metastatic colorectal cancer ( mCRC ) were improvable .
-BACKGROUND	We evaluated the independent prognostic value of QoL for overall survival ( OS ) and its ability to improve two prognostic systems ` performance ( Khne and GERCOR models ) for patients with mCRC .
-METHODS	The EQ-5D questionnaire was self-completed before randomization in the OPTIMOX1 , a phase III trial comparing two strategies of FOLFOX chemotherapy which included 620 previously untreated mCRC patients recruited from January 2000 to June 2002 from 56 institutions in five countries .
-METHODS	The improvement in models ' performance ( after addition of QoL ) was studied with Harrell 's C-index and the net reclassification improvement .
-RESULTS	Of the 620 patients , 249 ( 40 % ) completed QoL datasets .
-RESULTS	The Khne model could be improved by LDH , mobility and pain/discomfort ; the C-index rose from 0.54 to 0.67 .
-RESULTS	The associated NRI for 12-month death was 0.23 [ 0.05 ; 0.46 ] .
-RESULTS	Mobility and pain/discomfort could be added to the GERCOR model : the C-index varied from 0.63 to 0.68 .
-RESULTS	The NRI for 12 months death was 0.35 [ 0.12 ; 0.44 ] .
-CONCLUSIONS	Mobility and pain dimensions of EQ5D are independent prognostic factors and could be useful for staging and treatment assignment of mCRC patients .
-CONCLUSIONS	Presented at the 2011 ASCO Annual Meeting ( # 3632 ) .
-
-###25005452
-OBJECTIVE	To evaluate the safety of uninterrupted rivaroxaban , a novel oral anticoagulant that directly inhibits factor Xa , and a vitamin K antagonist ( VKA ) in eligible adult patients with nonvalvular AF ( NVAF ) who are scheduled for a catheter ablation .
-METHODS	This is a prospective , randomized , open-label , active-controlled , global multicenter safety study of up to 250 randomized patients .
-METHODS	Eligible patients with paroxysmal or persistent NVAF , a left ventricular ejection fraction > 40 % , and a creatinine clearance > 50mL/min will be randomized 1:1 to rivaroxaban 20mg orally once daily or to dose-adjusted oral VKA ( recommended international normalized ratio ( INR ) 2.0-3 .0 ) and stabilized on anticoagulation therapy for 1-7days ( if no intracardiac thrombus on transesophageal echocardiogram ( TEE ) immediately prerandomization/post-randomization or if 3weeks of sufficient anticoagulation is documented ) or for 4-5weeks ( if no TEE , no documented 3weeks of sufficient anticoagulation , or by patient choice ) .
-METHODS	During catheter ablation , heparin will be administered ( ACT-targeted range = 300-400s ) after catheter ablation , and VKA will be managed per usual care .
-METHODS	The next dose of rivaroxaban will be provided at least 6h after establishment of hemostasis .
-METHODS	The primary endpoint will be the incidence of post-procedure major bleeding events observed during the first 305days post-ablation .
-METHODS	Secondary endpoints will include post-procedure thromboembolic events , additional bleeding , time-to-event , and medication adherence .
-CONCLUSIONS	This study is intended to provide information about the safety characteristics of rivaroxaban in patients with NVAF undergoing catheter ablation .
-
-###25818976
-BACKGROUND	Isoperistaltic stapled side-to-side anastomosis ( SSSA ) , which is a modified technique from conventional antiperistaltic SSSA , has the benefits of antiperistaltic SSSA but requires less intestinal mobility .
-BACKGROUND	The aim of this randomized controlled trial was to evaluate short-term outcomes of isoperistaltic SSSA comparing them with antiperistaltic SSSA during colon cancer surgery .
-METHODS	We conducted a randomized controlled trial of patients with colon cancer who underwent elective curative resection and had enough intestinal mobility at anastomosis .
-METHODS	The primary outcome was the presence of anastomotic failure , including leakage , hemorrhage , and stenosis .
-RESULTS	Between July 2012 and January 2014 , forty patients were enrolled ( 20 patients in each group ) .
-RESULTS	The study was suspended on detecting excess morbidity in the isoperistaltic SSSA group .
-RESULTS	No significant differences were observed in all preoperative backgrounds between the two groups .
-RESULTS	Anastomotic leakage was seen in two patients in the isoperistaltic SSSA group , compared with none in the antiperistaltic SSSA group , although the difference was not statistically significant ( P = 0.487 ) .
-RESULTS	One patient in the antiperistaltic SSSA group had anastomotic stenosis , which improved conservatively , compared with none in the isoperistaltic SSSA group ( P = 1.000 ) .
-RESULTS	No anastomotic hemorrhage was seen in either group .
-RESULTS	There was no significant difference in the median postoperative hospital stay ( P = 0.313 ) .
-CONCLUSIONS	This study did not show any short-term advantage or disadvantage of isoperistaltic SSSA compared with that of antiperistaltic SSSA .
-CONCLUSIONS	However , considering that anastomotic leakage occurred only in the isoperistaltic SSSA group , additional modifications are recommended to perform safe isoperistaltic SSSA for colon surgery .
-
-###24601188
-OBJECTIVE	To compare the extraction time and infection rate of umbilical cord by applying ethanol , humanmilk or dry care .
-METHODS	The parallel single-blinded randomised clinical trial was performed on 300 neonates at Shahid Sadougi University of Medical Sciences and Health Service , Yazd , Iran , between March and September 2010 .
-METHODS	The neonates were divided into three random but numerically equal groups .
-METHODS	Each group was assigned the application of ethanol or mother 's milk or to keep the stump dry .
-METHODS	The neonates were visited on the 3rd and the 7th day after birth and follow-up was maintained telephonically until umbilical separation .
-METHODS	Umbilical separation time and umbilical local infection frequency were considered as the study outcome , which was compared among the three groups according to age , gender and delivery type of the neonates .
-RESULTS	Umbilical separation time in neonates of the human milk group had significant difference with the ethanol group ( p = 0.0001 ) and drying groups ( p = 0.003 ) .
-RESULTS	Frequency of omphalitis had no significant difference among the three groups .
-CONCLUSIONS	Topical usage of human milk on umbilical cord stamp decreased separation time and incidence rate of omphalitis .
-
-###25115420
-OBJECTIVE	This study was designed to determine whether the volume and type of fluid administered for pancreaticoduodenectomy impacts postoperative outcomes .
-BACKGROUND	Three percent hypertonic saline ( HYS ) has been suggested as a means of reducing the volume of fluid required to sustain tissue perfusion in the perioperative period .
-METHODS	Between May 2011 and November 2013 , patients undergoing pancreaticoduodenectomy were enrolled in an institutional review board-approved , single-center , prospective , parallel , randomized controlled trial ( NCT 01428050 ) , comparing lactated Ringers ( LAR ) ( 15 mL/kg/hr LAR intraoperation , 2 mL/kg/hr LAR postoperation ) with HYS ( 9 mL/kg/hr LAR and 1 mL/kg/hr HYS intraoperation , 1 mL/kg/hr HYS postoperation ) .
-RESULTS	A total of 264 patients were randomized .
-RESULTS	Demographic variables between groups were similar .
-RESULTS	The HYS patients had a significantly reduced net fluid balance ( 65 vs 91 mL/kg , P = 0.02 ) .
-RESULTS	The overall complication rate was reduced in the HYS group ( 43 % vs 54 % ) , with a relative risk of 0.79 [ 95 % confidence interval ( CI ) , 0.62-1 .02 ; P = 0.073 ] , factoring stratification for pancreas texture .
-RESULTS	After adjustment for age and weight , the relative risk was 0.75 [ 95 % CI ( 0.58-0 .96 ) ; P = 0.023 ] .
-RESULTS	The total number of complications was significantly reduced in the HYS group ( 93 vs 123 ) , with an incidence rate ratio of 0.74 [ 95 % CI ( 0.56-0 .97 ) ; P = 0.027 ] .
-RESULTS	After adjustment for age and weight , the incidence rate ratio was 0.69 [ 95 % CI ( 0.52-0 .90 ) ; P = 0.0068 ] .
-RESULTS	Reoperations , length of stay , readmissions , and 90-day mortality were similar between groups .
-CONCLUSIONS	A moderately restrictive fluid regimen with HYS resulted in a statistically significant 25 % reduction in complications when adjusted for age , weight , and pancreatic texture .
-
-###25483553
-OBJECTIVE	Kiwifruit contains bioactive substances that may lower blood pressure ( BP ) and improve endothelial function .
-OBJECTIVE	We examined the effects of adding kiwifruit to the usual diet on 24-h ambulatory BP , office BP and endothelial function .
-METHODS	In a parallel-groups study , 118 subjects with high normal BP or stage 1 hypertension ( systolic BP 130-159 mmHg and/or diastolic BP 85-99 mmHg ) were randomized to intake of three kiwifruits ( intervention ) or one apple ( control ) a day for 8 weeks .
-METHODS	Office and 24-h ambulatory BP was measured along with biomarkers of endothelial function including metabolites of nitric oxide ( NO ) formation and finger photo-plethysmography .
-RESULTS	At randomization , mean 24-h ambulatory systolic/diastolic BP was 133 13/82 9 mmHg ( n = 106 ) .
-RESULTS	After 8 weeks , BP was lower in the group assigned to kiwifruit versus apple intake ( between group difference , - 3.6 mmHg [ 95 % CI - 6.5 to - 0.7 ] , p = 0.017 and - 1.9 mmHg [ 95 % CI - 3.6 to - 0.3 ] ; p = 0.040 , for systolic and diastolic BP , respectively ) .
-RESULTS	Changes in office BP and endothelial function did not differ between the groups .
-CONCLUSIONS	Among men and women with moderately elevated BP , intake of three kiwifruits was associated with lower systolic and diastolic 24-h BP compared with one apple a day .
-CONCLUSIONS	The effect may be regulated by mechanisms other than improvement of endothelial function .
-
-###24632760
-OBJECTIVE	The study objective was to assess the efficacy of problem-solving therapy for primary care ( PST-PC ) for preventing episodes of major depression and mitigating depressive symptoms of older black and white adults .
-OBJECTIVE	The comparison group received dietary coaching .
-METHODS	A total of 247 participants ( 90 blacks , 154 whites , and three Asians ) with subsyndromal depressive symptoms were recruited into a randomized depression prevention trial that compared effects of individually delivered PST-PC and dietary coaching on time to major depressive episode and level of depressive symptoms ( Beck Depression Inventory ) over two years .
-METHODS	Cumulative intervention time averaged 5.5-6 .0 hours in each study arm .
-RESULTS	The two groups did not differ significantly in time to major depressive episodes , and incidence of such episodes was low ( blacks , N = 8 , 9 % ; whites , N = 13 , 8 % ) , compared with published rates of 20 % -25 % over one year among persons with subsyndromal symptoms and receiving care as usual .
-RESULTS	Participants also showed a mean decrease of 4 points in depressive symptoms , sustained over two years .
-RESULTS	Despite greater burden of depression risk factors among blacks , no significant differences from whites were found in the primary outcome .
-CONCLUSIONS	Both PST-PC and dietary coaching are potentially effective in protecting older black and white adults with subsyndromal depressive symptoms from developing episodes of major depression over two years .
-CONCLUSIONS	Absent a control for concurrent usual care , this conclusion is preliminary .
-CONCLUSIONS	If confirmed , both interventions hold promise as scalable , safe , nonstigmatizing interventions for delaying or preventing episodes of major depression in the nation 's increasingly diverse older population .
-
-###24326731
-OBJECTIVE	To evaluate the effect of 8-week moderate intensity aerobic ( heart-rate reserve 40-60 % ) exercise on neuropathy quality of life in type 2 diabetes .
-METHODS	A single blind , parallel-group , randomized controlled trial was carried out in a tertiary setting .
-METHODS	People with type 2 diabetes were eligible for the study if they had clinical neuropathy which was defined by a minimum score of seven on the Michigan diabetic neuropathy score .
-METHODS	Following which , the patients were randomly assigned to an 8-week program by a computer-generated random number tables to intervention or control group .
-METHODS	Repeated measure analysis of variance was used for data analysis ( p < 0.05 was considered significant ) .
-RESULTS	There were 47 participants in the control group and 40 participants in the study group after randomization but 37 from the control group and 29 from the intervention group completed the final analysis .
-RESULTS	The two groups had a significant difference , pre-post intervention in scores of pain ( F = 7 , p = 0.01 ) , sensory symptoms ( F = 4.60 , p = 0.04 ) , restricted activities of daily living ( F = 4.97 , p = 0.03 ) , disruptions in social relationships ( F = 5.43 , p = 0.02 ) , specific impact on quality of life ( F = 9.28 , p < 0.001 ) overall quality of life ( F = 28.72 , p < 0.001 ) , and total score ( F = 31.10 , p < 0.001 ) .
-RESULTS	Degrees of freedom for all the components were 1 , 62 .
-CONCLUSIONS	Moderate intensity aerobic exercise is cornerstone in improving the quality of life of individuals with peripheral neuropathy in type 2 diabetes .
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-###24922162
-OBJECTIVE	We examined whether It 's Your Game ... Keep It Real ( IYG ) reduced dating violence among ethnic-minority middle school youths , a population at high risk for dating violence .
-METHODS	We analyzed data from 766 predominantly ethnic-minority students from 10 middle schools in southeast Texas in 2004 for a group randomized trial of IYG .
-METHODS	We estimated logistic regression models , and the primary outcome was emotional and physical dating violence perpetration and victimization by ninth grade .
-RESULTS	Control students had significantly higher odds of physical dating violence victimization ( adjusted odds ratio [ AOR ] = 1.52 ; 95 % confidence interval [ CI ] = 1.20 , 1.92 ) , emotional dating violence victimization ( AOR = 1.74 ; 95 % CI = 1.36 , 2.24 ) , and emotional dating violence perpetration ( AOR = 1.58 ; 95 % CI = 1.11 , 2.26 ) than did intervention students .
-RESULTS	The odds of physical dating violence perpetration were not significantly different between the 2 groups .
-RESULTS	Program effects varied by gender and race/ethnicity .
-CONCLUSIONS	IYG significantly reduced 3 of 4 dating violence outcomes among ethnic-minority middle school youths .
-CONCLUSIONS	Although further study is warranted to determine if IYG should be widely disseminated to prevent dating violence , it is one of only a handful of school-based programs that are effective in reducing adolescent dating violence behavior .
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-###25759552
-OBJECTIVE	To explore the effect of intravariceal-mucosal sclerotherapy using small dose of sclerosant on the recurrence of esophageal varices .
-METHODS	We randomly assigned 38 cirrhotic patients with previous variceal bleeding and high variceal pressure ( > 15.2 mmHg ) to receive endoscopic variceal ligation ( EVL ) and combined intravariceal and esophageal mucosal sclerotherapy ( combined group ) using small-volume sclerosant .
-METHODS	The end-points of the study were rebleeding and recurrence of esophageal varices .
-RESULTS	During a median follow-up period of 16 mo , varices recurred in 1 patient in the combined group as compared with 7 patients in the EVL group ( P = 0.045 ) .
-RESULTS	Rebleeding occurred in 3 patients in the EVL group as compared with 1 patient in the combined group ( P = 0.687 ) .
-RESULTS	No patient died in the two groups .
-RESULTS	No significant differences were observed between the two groups with respect to serious adverse events .
-CONCLUSIONS	Intravariceal-mucosal sclerotherapy using small dose of sclerosant is more effective than EVL in decreasing the incidence of variceal recurrence for cirrhotic patients .
-
-###24635387
-OBJECTIVE	There is considerable interest in pharmacogenetic and molecular biomarkers .
-OBJECTIVE	Our aim was to evaluate the effects of enalapril/lercanidipine combination on some emerging biomarkers for cardiovascular risk stratification of hypertensive patients , such as lipoprotein ( a ) [ Lp ( a ) ] , soluble advanced glycation end products ( sRAGE ) , soluble CD40 ligand ( sCD40L ) and serum myeloperoxidase ( MPO ) .
-METHODS	Three hundred and forty-five patients were enrolled in this randomized , double-blind , clinical trial : 120 hypertensive patients were randomized to enalapril 20 mg , 110 to lercanidipine 10 mg and 115 to enalapril/lercanidipine 20/10 mg fixed combination .
-METHODS	We measures the following markers at baseline and after 6 , 12 , 18 and 24 months : blood pressure , fasting plasma glucose ( FPG ) , lipid profile , Lp ( a ) , sRAGE , sCD40L and MPO .
-RESULTS	There was a decrease in blood pressure in all groups compared with baseline , even if , as expected , enalapril/lercanidipine combination was more effective in reducing blood pressure compared with the monotherapies .
-RESULTS	No variations in lipid profile or FPG were recorded in any of the groups .
-RESULTS	Lercanidipine , but not enalapril , improved Lp ( a ) levels compared with baseline .
-RESULTS	The combination enalapril/lercanidipine improved it more than the single therapies .
-RESULTS	All treatments increased sRAGE levels , and decreased sCD40L and MPO , with a better effect seen with the enalapril/lercanidipine combination compared with single monotherapies .
-CONCLUSIONS	The combination enalapril/lercanidipine seems to be better than the single monotherapies in reducing not only blood pressure , but also the levels of some emerging biomarkers , potentially useful for cardiovascular risk stratification of hypertensive patients .
-
-###25666002
-BACKGROUND	There is a paucity of literature on the use of honey in wound healing after oral and maxillofacial surgical procedures .
-OBJECTIVE	To evaluate the efficacy of the healing properties of Obudu honey in patients who developed wound dehiscence after segmental mandibular resections .
-METHODS	This was a prospective study of 72 patients who had benign lesions of the mandible , and were treated by segmental mandibular resection , with the surgical wounds developing dehiscence .
-METHODS	The subjects were randomized into two treatment groups of A ( control , n = 36 ) and B ( experimental , n = 36 ) .
-METHODS	Unlike the control , the wounds in the experimental group were dressed in honey after debridement .
-RESULTS	The ages of the patients ranged from 21 to 73 years with a mean age of 46.3 2.1 years while the male : female ratio was 3:1 .
-RESULTS	There was no significant demographic difference about age ( P = 0.44 ) and gender ( P = 0.38 ) between the two groups .
-RESULTS	The smaller the initial circumference of the surgical wound , the shorter the duration of healing and this was significant ( P = 0.001 ) in either of the treatment groups .
-RESULTS	Numerically , more healing was completed in the first 5 weeks in subjects in the experimental group ( n = 19 , 52.8 % ) than the control ( n = 13 , 36.1 % ) .
-RESULTS	However , the duration of healing between the subjects in the control and experimental groups at the end of 9 weeks showed no significant difference ( P = 0.23 ) .
-CONCLUSIONS	Honey speeds up the healing of dehiscence wounds of resected mandible when used as dressing more than the control .
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-###24323178
-OBJECTIVE	We aimed to evaluate the efficacy and safety of fully covered esophageal stent placement for preventing esophageal strictures after endoscopic submucosal dissection ( ESD ) .
-METHODS	Twenty-two patients with a mucosal defects that exceeded 75 % of the circumference of the esophagus after ESD treatment for superficial esophageal squamous cell carcinomas were grouped according to the type of mucosal defect and randomized to undergo fully covered esophageal stent placement post-ESD ( group A , n = 11 ) or no stent placement ( group B , n = 11 ) .
-METHODS	In group A , the esophageal stents were removed 8 weeks post-ESD .
-METHODS	Endoscopy was performed when patients reported dysphagia symptoms and at 12 weeks post-ESD in patients without symptoms .
-METHODS	Savary-Gilliard dilators were used for bougie dilation in patients experiencing esophageal stricture in both groups , and we compared the rates of post-ESD strictures and the need for bougie dilation procedures .
-RESULTS	The proportion of patients who developed a stricture was significantly lower in group A ( 18.2 % , n = 2 ) than in group B ( 72.7 % , n = 8 ) ( P < 0.05 ) .
-RESULTS	Moreover , the number of bougie dilation procedures was significantly lower in group A ( mean 0.45 , range 0-3 ) than in group B ( mean 3.9 , range 0-17 ) ( P < 0.05 ) .
-RESULTS	The two patients in group A who experienced stricture also had stent displacement .
-CONCLUSIONS	Esophageal stents are a safe and effective method of preventing esophageal strictures in cases where > 75 % of the circumference of the esophagus has mucosal defects after ESD treatment for early esophageal cancer .
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-###25432920
-OBJECTIVE	Does culture in a closed system result in an increased number of good quality embryos ( GQE ) on Day 2 compared with culture in a conventional system ?
-CONCLUSIONS	Culture in a closed system up to 2 days after microinjection results in similar embryo development and morphological quality compared with culture in a conventional incubation system .
-BACKGROUND	Time-lapse imaging ( TLI ) incubators are rapidly being introduced into IVF laboratories worldwide , despite the lack of large prospective randomized trials demonstrating improvement in embryo development or pregnancy rates .
-METHODS	A randomized controlled trial including 364 patients ( 365 cycles ) was conducted between May 2010 and February 2014 .
-METHODS	After oocyte collection , randomization was carried out and all of a patients ' oocytes were allocated to culture in either a conventional incubator or a closed incubator system in proportion 1:2 until embryo transfer on Day 2 .
-METHODS	A total of 1979 oocytes were injected and cultured in the closed system , and 1000 in the standard incubator .
-METHODS	The primary end-point was the number of GQE in the two groups .
-METHODS	In total , 364 patients undergoing their first IVF cycle using ICSI , where at least one oocyte was retrieved , were randomized in a university hospital setting .
-METHODS	Two hundred and forty patients were randomized for culture in a closed system and 124 patients for culture in the conventional incubator system ( control group ) .
-METHODS	Embryo assessments and final morphological scoring before transfer and cryopreservation were carried out at the same time points for embryos cultured in the conventional incubator and in the closed system .
-RESULTS	There was no significant difference in the mean SD number of GQEs between groups : 2.41 2.27 for the closed system group and 2.19 1.82 for the control group ( P = 0.34 , difference 0.23 , 95 % confidence interval 0.69 ; -0.24 ) .
-RESULTS	No significant differences were found in the number of 4-cell embryos , implantation - , pregnancy - or ongoing pregnancy rates .
-RESULTS	A significantly higher miscarriage rate was found in the TLI group compared with the control group ( 33.3 and 10.2 % , P = 0.01 ) .
-CONCLUSIONS	Culture media , temperature and gas levels were similar in the open and closed incubator systems , but different culture dishes were used .
-CONCLUSIONS	Culturing embryos for longer time period ( to the blastocyst stage ) may give different results .
-CONCLUSIONS	Only ICSI patients were included , which may limit the generalizability of the results .
-CONCLUSIONS	Finally , the number of GQEs on Day 2 was used as a surrogate outcome for live birth .
-CONCLUSIONS	The results are consistent with other , smaller randomized trials showing no difference in embryo quality when comparing culture in a conventional incubator with that of a closed TLI incubator system .
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-###25108889
-BACKGROUND	The European Randomised study of Screening for Prostate Cancer ( ERSPC ) has shown significant reductions in prostate cancer mortality after 9 years and 11 years of follow-up , but screening is controversial because of adverse events such as overdiagnosis .
-BACKGROUND	We provide updated results of mortality from prostate cancer with follow-up to 2010 , with analyses truncated at 9 , 11 , and 13 years .
-METHODS	ERSPC is a multicentre , randomised trial with a predefined centralised database , analysis plan , and core age group ( 55-69 years ) , which assesses prostate-specific antigen ( PSA ) testing in eight European countries .
-METHODS	Eligible men aged 50-74 years were identified from population registries and randomly assigned by computer generated random numbers to screening or no intervention ( control ) .
-METHODS	Investigators were masked to group allocation .
-METHODS	The primary outcome was prostate cancer mortality in the core age group .
-METHODS	Analysis was by intention to treat .
-METHODS	We did a secondary analysis that corrected for selection bias due to non-participation .
-METHODS	Only incidence and no mortality data at 9 years ' follow-up are reported for the French centres .
-METHODS	This study is registered with Current Controlled Trials , number ISRCTN49127736 .
-RESULTS	With data truncated at 13 years of follow-up , 7408 prostate cancer cases were diagnosed in the intervention group and 6107 cases in the control group .
-RESULTS	The rate ratio of prostate cancer incidence between the intervention and control groups was 191 ( 95 % CI 183-199 ) after 9 years ( 164 [ 158-169 ] including France ) , 166 ( 160-173 ) after 11 years , and 157 ( 151-162 ) after 13 years .
-RESULTS	The rate ratio of prostate cancer mortality was 085 ( 070-103 ) after 9 years , 078 ( 066-091 ) after 11 years , and 079 ( 069-091 ) at 13 years .
-RESULTS	The absolute risk reduction of death from prostate cancer at 13 years was 011 per 1000 person-years or 128 per 1000 men randomised , which is equivalent to one prostate cancer death averted per 781 ( 95 % CI 490-1929 ) men invited for screening or one per 27 ( 17-66 ) additional prostate cancer detected .
-RESULTS	After adjustment for non-participation , the rate ratio of prostate cancer mortality in men screened was 073 ( 95 % CI 061-088 ) .
-CONCLUSIONS	In this update the ERSPC confirms a substantial reduction in prostate cancer mortality attributable to testing of PSA , with a substantially increased absolute effect at 13 years compared with findings after 9 and 11 years .
-CONCLUSIONS	Despite our findings , further quantification of harms and their reduction are still considered a prerequisite for the introduction of populated-based screening .
-BACKGROUND	Each centre had its own funding responsibility .
-
-###24978844
-OBJECTIVE	This secondary analysis investigated the impact of 12 sessions of Seeking Safety ( SS ) on reducing posttraumatic stress disorder ( PTSD ) symptoms in a sample of dually diagnosed women with physical disabilities versus nondisabled ( ND ) women .
-OBJECTIVE	SS is an evidence-based and widely implemented manualized therapy for PTSD and/or substance use disorder .
-OBJECTIVE	It is a present-focused model that promotes coping skills and psychoeducation .
-METHODS	As part of the National Institute on Drug Abuse Clinical Trials Network ( NIDA CTN ) , 353 participants with current PTSD and substance use disorder ( SUD ) were randomly assigned to partial-dose SS or Women 's Health Education ( WHE ) group therapy conducted in community-based substance abuse treatment programs .
-METHODS	The women were categorized as participants with disabilities ( PWD ; n = 20 ) or ND ( n = 333 ) based on the question , `` Do you receive a pension for a physical disability ? ''
-METHODS	PTSD was assessed on the Clinician-Administered PTSD Scale ( CAPS ) at baseline and follow-ups after treatment ( 1 week , 3 months , 6 months , and 12 months ) .
-RESULTS	PWD experienced sustained reductions in PTSD symptoms when treated with SS but not WHE .
-RESULTS	Indeed , PTSD symptoms of PWD in WHE returned to baseline levels of severity by 12-month follow-up .
-RESULTS	This pattern of results was not observed among ND women , who sustained improvements on PTSD in both treatment conditions .
-CONCLUSIONS	These results suggest strong potential for using SS to treat PTSD among women with physical disabilities , and speak to the genuine need to address trauma and PTSD more directly with PWD .
-CONCLUSIONS	Our results are also consistent with other findings from the NIDA CTN trial , in which virtually all significant results evidenced SS outperforming WHE .
-
-###25085036
-OBJECTIVE	To evaluate the effect of sevoflurane or ketamine on the corrected QT ( QTc ) interval and the interval from the peak to the end of the T wave ( Tp-e ) during electroconvulsive therapy ( ECT ) in patients with major depression .
-METHODS	This prospective , randomized , double-blinded study included 24 patients that were randomly allocated to receive sevoflurane ( group S ) or ketamine ( group K ) for ECT session .
-METHODS	Group S patients received 8 % sevoflurane for anesthesia induction , which was maintained at 2-4 % until delivery of the electrical stimulus .
-METHODS	Group K patients received a bolus of ketamine ( 1mg/kg ) .
-METHODS	The mean arterial pressure ( MAP ) and heart rate ( HR ) and the electrocardiogram ( ECG ) were recorded before ( T1 ) and after induction of anesthesia ( T2 ) and 0 , 1 , 3 , and 10min after the electrical stimuli ended ( T3 , T4 , T5 , and T6 , respectively ) .
-RESULTS	In both groups , the QTc interval was significantly longer at T2 , T4 , T5 , and T6 than at baseline .
-RESULTS	The QTc interval was longer at T4 , T5 , and T6 in group S compared to that in group K , the Tp-e interval was significantly longer at T4 in group K both baseline and group S.
-RESULTS	The HR in group S was increased at T4 compared with group K. MAP was significantly higher after induction of anesthesia in group K compared to those in group S at all time points .
-CONCLUSIONS	Although group S showed a prolonged QTc interval after ECT compared to group K , the Tp-e interval in both groups was not significantly affected clinically .
-CONCLUSIONS	Sevoflurane blunted MAP and peak HR .
-
-###25853745
-BACKGROUND	Fresh red cells may improve outcomes in critically ill patients by enhancing oxygen delivery while minimizing the risks of toxic effects from cellular changes and the accumulation of bioactive materials in blood components during prolonged storage .
-METHODS	In this multicenter , randomized , blinded trial , we assigned critically ill adults to receive either red cells that had been stored for less than 8 days or standard-issue red cells ( the oldest compatible units available in the blood bank ) .
-METHODS	The primary outcome measure was 90-day mortality .
-RESULTS	Between March 2009 and May 2014 , at 64 centers in Canada and Europe , 1211 patients were assigned to receive fresh red cells ( fresh-blood group ) and 1219 patients were assigned to receive standard-issue red cells ( standard-blood group ) .
-RESULTS	Red cells were stored a mean ( SD ) of 6.14.9 days in the fresh-blood group as compared with 22.08.4 days in the standard-blood group ( P < 0.001 ) .
-RESULTS	At 90 days , 448 patients ( 37.0 % ) in the fresh-blood group and 430 patients ( 35.3 % ) in the standard-blood group had died ( absolute risk difference , 1.7 percentage points ; 95 % confidence interval [ CI ] , -2.1 to 5.5 ) .
-RESULTS	In the survival analysis , the hazard ratio for death in the fresh-blood group , as compared with the standard-blood group , was 1.1 ( 95 % CI , 0.9 to 1.2 ; P = 0.38 ) .
-RESULTS	There were no significant between-group differences in any of the secondary outcomes ( major illnesses ; duration of respiratory , hemodynamic , or renal support ; length of stay in the hospital ; and transfusion reactions ) or in the subgroup analyses .
-CONCLUSIONS	Transfusion of fresh red cells , as compared with standard-issue red cells , did not decrease the 90-day mortality among critically ill adults .
-CONCLUSIONS	( Funded by the Canadian Institutes of Health Research and others ; Current Controlled Trials number , ISRCTN44878718 . )
-
-###25316485
-OBJECTIVE	To determine whether the benefits of sentinel node based management ( SNBM ) over routine axillary clearance ( RAC ) at 1 year persisted to 3 years of follow-up .
-METHODS	A total of 1,088 women with clinically node-negative breast cancer were randomly assigned to the SNBM or RAC group .
-METHODS	Upper limb volume , symptoms , and function were assessed at 1 , 6 , 12 , 24 , and 36 months after surgery objectively with upper limb measurements by clinicians and subjectively by patients ' using validated self-rating scales .
-RESULTS	Upper limb volume increased in both groups over the first 2 years and differed between the two groups all time points beyond 1 month ( P < 0.02 ) but then plateaued .
-RESULTS	Upper limb swelling was no worse in women who had axillary clearance as a two-stage procedure than in women assigned RAC as a one-stage procedure .
-RESULTS	Upper limb volume had increased 15 % or more in 6.0 % at 6 months and 17.6 % at 3 years in those assigned RAC versus 4.2 and 11.9 % in those assigned SNBM .
-RESULTS	Reductions in upper limb movement were also greater , with RAC than SNBM over 6 months , but improved and were similar in the two groups from 1 to 3 years .
-RESULTS	Subjective ratings of upper limb swelling , symptoms , dysfunction , and disability over 3 years were worse in the RAC group .
-RESULTS	Upper limb swelling at 3 years was rated severe by few women ( 1.1 % ) but was rated as moderate by 9.4 % in the RAC group and 2.5 % in the SNBM group ( P < 0.001 ) .
-CONCLUSIONS	The benefits of SNBM over RAC persist 3 years after surgery .
-
-###24432992
-BACKGROUND	Recent evidence suggests thyroidectomy ( Tx ) followed by radioiodine remnant ablation to be beneficial to Graves ' orbitopathy ( GO ) patients .
-OBJECTIVE	The aim of the study was to evaluate the effect of ( 131 ) I thyroid ablation after recombinant human TSH stimulation in patients with moderate-to-severe GO .
-METHODS	The study was prospective , randomized , and single-blind , and it included 40 consecutive patients with moderate-to-severe GO randomized into : 1 ) a Tx-radioactive iodine ( RAI ) group ( 20 subjects who underwent total-Tx and ( 131 ) I ablation after recombinant human TSH stimulation ) ; and 2 ) a Tx group ( 20 subjects who underwent total-Tx alone ) .
-METHODS	The overall GO outcome 12 months after Tx/radioiodine ablation was the main measure .
-RESULTS	GO evaluation at the end of iv glucocorticoids showed eye disease to be improved in 65 % of the Tx-RAI group and 60 % of the Tx group patients .
-RESULTS	At 6 and 12 months , no further changes in the GO outcome could be observed in the Tx-RAI group .
-RESULTS	Conversely , five patients from the Tx group exhibited a deterioration in GO .
-RESULTS	At 12 months , GO was found to be improved in 70 % of the Tx-RAI and 20 % of the Tx group patients , the latter being found to be stable ( 55 % ) or worse ( 25 % ) than at baseline evaluation .
-RESULTS	At 12 months , GO was found to be inactive in a significantly higher percentage of patients in the Tx-RAI than in the Tx group ( 75 vs 30 % ; P < .01 ) .
-CONCLUSIONS	Postoperative radioiodine ablation proved more effective than Tx alone in inducing earlier and steadier GO improvement in patients with moderate-to-severe GO treated with iv glucocorticoids over a 24-month follow-up period .
-
-###24445833
-BACKGROUND	Strains of 2 distinct influenza B lineages ( Victoria and Yamagata ) have cocirculated in the United States for over a decade , but trivalent influenza vaccines ( TIVs ) contain only 1 B-lineage strain .
-BACKGROUND	Each season , some or most influenza B disease is caused by the B lineage not represented in that season 's TIV .
-BACKGROUND	Quadrivalent influenza vaccines ( QIVs ) containing a strain from each B lineage should resolve this problem .
-METHODS	This was a Phase III , randomized , multicenter trial in the United States among children 6 months to < 9 years of age to evaluate the safety and immunogenicity of inactivated QIV compared with inactivated control TIVs containing opposite B-lineage strains .
-METHODS	Participants were randomized at a ratio of approximately 4:1:1 to receive QIV , TIV containing a Victoria-lineage B strain or TIV containing a Yamagata-lineage B strain .
-METHODS	Sera were collected pre - and 28-days post-final vaccination and safety was assessed for 6 months after the last injection .
-RESULTS	A total of 4363 participants were enrolled .
-RESULTS	QIV induced noninferior antibody responses to all A strains and corresponding B strains compared with the control TIVs and superior antibody responses to the noncorresponding B strain in each TIV .
-RESULTS	Rates of solicited reactions and unsolicited and serious adverse events were similar in all groups .
-CONCLUSIONS	This study demonstrated that QIV is safe and immunogenic among children 6 months to < 9 years of age .
-CONCLUSIONS	These findings , along with data from 2 other studies of this QIV in adults , suggest that QIV should offer protection against both B lineages with a safety profile similar to TIV across all ages .
-
-###24454728
-BACKGROUND	The HPTN 052 trial confirmed that antiretroviral therapy ( ART ) can nearly eliminate HIV transmission from successfully treated HIV-infected individuals within couples .
-BACKGROUND	Here , we present the mathematical modeling used to inform the design and monitoring of a new trial aiming to test whether widespread provision of ART is feasible and can substantially reduce population-level HIV incidence .
-RESULTS	The HPTN 071 ( PopART ) trial is a three-arm cluster-randomized trial of 21 large population clusters in Zambia and South Africa , starting in 2013 .
-RESULTS	A combination prevention package including home-based voluntary testing and counseling , and ART for HIV positive individuals , will be delivered in arms A and B , with ART offered universally in arm A and according to national guidelines in arm B. Arm C will be the control arm .
-RESULTS	The primary endpoint is the cumulative three-year HIV incidence .
-RESULTS	We developed a mathematical model of heterosexual HIV transmission , informed by recent data on HIV-1 natural history .
-RESULTS	We focused on realistically modeling the intervention package .
-RESULTS	Parameters were calibrated to data previously collected in these communities and national surveillance data .
-RESULTS	We predict that , if targets are reached , HIV incidence over three years will drop by > 60 % in arm A and > 25 % in arm B , relative to arm C.
-RESULTS	The considerable uncertainty in the predicted reduction in incidence justifies the need for a trial .
-RESULTS	The main drivers of this uncertainty are possible community-level behavioral changes associated with the intervention , uptake of testing and treatment , as well as ART retention and adherence .
-CONCLUSIONS	The HPTN 071 ( PopART ) trial intervention could reduce HIV population-level incidence by > 60 % over three years .
-CONCLUSIONS	This intervention could serve as a paradigm for national or supra-national implementation .
-CONCLUSIONS	Our analysis highlights the role mathematical modeling can play in trial development and monitoring , and more widely in evaluating the impact of treatment as prevention .
-
-###25479899
-BACKGROUND	Patients with Kawasaki disease ( KD ) are at risk for developing coronary artery lesions , but the association of noncoronary changes such as mitral regurgitation ( MR ) and/or pericardial effusion ( PE ) with cardiac mechanics in the acute phase of KD has not been previously described .
-BACKGROUND	The aim of this study was to test the hypothesis that these noncoronary markers for carditis are associated with abnormalities in strain ( ) and strain rate ( SR ) in patients with MR or PE not appreciated by conventional echocardiography .
-METHODS	Longitudinal and circumferential and SR analyses were retrospectively performed on patients with KD .
-METHODS	Patients with and without MR or PE were compared .
-METHODS	Strain values were also compared between patients with and without coronary artery lesions .
-METHODS	Values for ejection fraction , shortening fraction , and clinical laboratory parameters were correlated with MR or PE .
-METHODS	Follow-up echocardiographic outcomes were recorded at the first encounter after initial diagnosis .
-METHODS	Follow-up and SR data were also obtained in the group with MR or PE and altered ventricular mechanics at diagnosis .
-RESULTS	Of the 110 patients reviewed , 92 had appropriate image quality for either longitudinal and SR or circumferential and SR analysis .
-RESULTS	Twenty-eight patients ( 30 % ) had either MR or PE .
-RESULTS	Longitudinal and SR were significantly decreased in patients with MR or PE compared with patients without MR or PE ( : -16.44.0 % vs -19.03.7 % , P = .004 ; SR : -1.30.7 vs -1.60.4 sec ( -1 ) , P = .03 ) .
-RESULTS	No significant difference in longitudinal or SR was noted between patients with and without coronary artery lesions ( : -17.94.1 % vs -17.83.8 % , P = .50 ; SR : -1.50.3 vs -1.60.8 sec ( -1 ) , P = .50 ) .
-RESULTS	In the group with abnormal coronary arteries , presence of MR or PE was correlated with decreased longitudinal ( -16.13.6 % vs -18.93.4 % , P = .02 ) , without a significant difference in longitudinal SR ( -1.60.4 vs -1.50.4 sec ( -1 ) , P = .20 ) .
-RESULTS	At approximately 3-week follow-up ( 21.315.8 days ) , longitudinal and SR for the group with MR or PE had increased significantly compared with diagnosis ( : -16.44.3 % vs -18.60.5 % , P = .03 ; SR : -1.30.6 vs -1.80.4 sec ( -1 ) , P = .008 ) , coincident with resolution of MR or PE .
-RESULTS	In both groups , erythrocyte sedimentation rate and C-reactive protein were elevated ( 85.336.2 mm/h vs 75.133.1 mm/h [ P = .34 ] and 12.36.7 vs 11.78.2 mg/dL [ P = .83 ] ) , but only modest correlations were noted between longitudinal and elevated erythrocyte sedimentation rate ( r = 0.52 , P = .01 ; confidence interval , 0.10-0 .80 ) and C-reactive protein ( r = 0.50 , P = .02 ; confidence interval , 0.10-0 .80 ) in patients with MR or PE .
-RESULTS	Shortening fraction and ejection fraction were within the normal range in both groups .
-CONCLUSIONS	Patients presenting with KD with MR or PE at diagnosis are likely to have altered ventricular mechanics compared with patients with KD without MR or PE despite normal conventional echocardiographic measures of function .
-CONCLUSIONS	There is no significant difference in ventricular mechanics when comparing patients with KD with coronary ectasia or aneurysms and those without coronary lesions .
-CONCLUSIONS	Presence of abnormal in patients with KD with altered ventricular mechanics correlates modestly with laboratory inflammatory markers .
-CONCLUSIONS	Peak systolic longitudinal and SR increased significantly at 3-week follow-up compared with initial diagnosis , coincident with resolution of MR or PE .
-
-###24739260
-BACKGROUND	Loss of lean body mass ( LBM ) is a common occurrence after treatment for breast cancer and is related to deleterious metabolic health outcomes [ Clin Oncol , 22 ( 4 ) :281 -288 , 2010 ; Appl Physiol Nutr Metab , 34 ( 5 ) :950 -956 , 2009 ] .
-BACKGROUND	The aim of this research is to determine the effectiveness of long chain omega-3 fatty acids ( LCn-3s ) and exercise training alone , or in combination , in addressing LBM loss in breast cancer survivors .
-METHODS	A total of 153 women who have completed treatment for breast cancer in the last 12 months , with a Body Mass Index ( BMI ) of 20 to 35 kg/m2 , will be randomly assigned to one of 3 groups : 3g/d LCn-3s ( N-3 ) , a 12-week nutrition and exercise education program plus olive oil ( P-LC ) or the education program plus LCn-3s ( EX+N -3 ) .
-METHODS	Participants randomised to the education groups will be blinded to treatment , and will receive either olive oil placebo ( OO+N -3 ) or LCn-3 provision , while the N-3 group will be open label .
-METHODS	The education program includes nine 60-75 min sessions over 12 weeks that will involve breast cancer specific healthy eating advice , plus a supervised exercise session run as a resistance exercise circuit .
-METHODS	They will also be advised to conduct the resistance training and aerobic training 5 to 7 days per week collectively .
-METHODS	Outcome measures will be taken at baseline , 12-weeks and 24-weeks .
-METHODS	The primary outcome is % change in LBM as measured by the air displacement plethysmograhy .
-METHODS	Secondary outcomes include quality of life ( FACT-B + 4 ) and inflammation ( C-Reactive protein : CRP ) .
-METHODS	Additional measures taken will be erythrocyte fatty acid analysis , fatigue , physical activity , menopausal symptoms , dietary intake , joint pain and function indices .
-CONCLUSIONS	This research will provide the first insight into the efficacy of LCn-3s alone or in combination with exercise in breast cancer survivors with regards to LBM and quality of life .
-CONCLUSIONS	In addition , this study is designed to improve evidence-based dietetic practice , and how specific dietary prescription may link with appropriate exercise interventions .
-BACKGROUND	ACTRN12610001005044 ; and World Health Organisation Universal trial number : U1111-1116-8520 .
-
-###25417605
-OBJECTIVE	To determine if training with a chicken wing model improves performance of endoscopic endonasal surgery ( EES ) with microvascular dissection .
-METHODS	Randomized experimental study .
-METHODS	A single-blinded randomized clinical trial of trainees with various levels of endoscopic experience was conducted to determine if prior training on a nonhuman model augments endoscopic skill and efficiency in a surrogate model for live surgery .
-METHODS	Medical students , residents , and fellows were randomized to two groups : a control group that performed an endoscopic transantral internal maxillary artery dissection on a silicone-injected anatomical specimen , and an interventional group that underwent microvascular dissection training on a chicken wing model prior to performing the anatomic dissection on the cadaver specimen .
-METHODS	Time to completion and quality of dissection were measured .
-RESULTS	A Mann-Whitney test demonstrated a significant improvement in time and quality outcomes respectively across all interventional groups , with the greatest improvements seen in participants with less endoscopic experience : medical students ( P = .032 , P = .008 ) , residents and fellows ( P = .016 , P = .032 ) .
-CONCLUSIONS	Prior training on the chicken wing model improves surgical performance in a surrogate model for live EES .
-
-###26250771
-BACKGROUND	Intranasal corticosteroids are the mainstay of allergic rhinitis ( AR ) treatment .
-BACKGROUND	Their potential to suppress the hypothalamic-pituitary-adrenal axis should be evaluated , especially after long-term daily use in children .
-OBJECTIVE	To evaluate the effects of treatment with non-aqueous beclomethasone dipropionate ( BDP ) nasal aerosol on hypothalamic-pituitary-adrenal axis function in children with perennial AR .
-METHODS	In this double-blinded , placebo-controlled , parallel-group study , patients ( 6-11 years old ) with perennial AR were randomized ( 2:1 ) to BDP nasal aerosol at 80 g/day ( n = 67 ) or placebo ( n = 32 ) .
-METHODS	The primary end point was change from baseline in 24-hour serum cortisol ( SC ) weighted mean for BDP nasal aerosol and placebo after 6 weeks of treatment , which was analyzed in the per-protocol population .
-RESULTS	The per-protocol population included 97 patients ( BDP nasal aerosol , n = 66 ; placebo , n = 31 ) .
-RESULTS	Baseline geometric mean SC weighted mean values were similar in the 80-g/day BDP nasal aerosol and placebo groups ( 5.97 and 6.47 g/dL , respectively ) .
-RESULTS	After 6 weeks ' treatment , geometric mean values were 6.19 and 7.13 g/dL , respectively , with no decrease from baseline in either group .
-RESULTS	Geometric mean SC ratio ofBDP nasal aerosol at 80 g/day to placebo was 0.91 ( 95 % confidence interval 0.81-1 .03 ) , indicating predefined noninferiority .
-RESULTS	SC concentration-time profiles were similar for the placebo and 80-g/day BDP nasal aerosol groups at baseline and week 6 .
-RESULTS	BDP nasal aerosol at 80 g/day was generally well tolerated .
-CONCLUSIONS	In pediatric patients with perennial AR , 24-hour SC profiles were comparable for BDP nasal aerosol and placebo , indicating that once-daily BDP nasal aerosol treatment did not significantly affect hypothalamic-pituitary-adrenal axis function .
-BACKGROUND	ClinicalTrials.gov ; NCT01697956 .
-
-###24312194
-METHODS	Twenty vertically HIV-infected children , 6-16 years of age , with stable viral load control and CD4 + values above 400 cells/mm ( 3 ) .
-METHODS	Ten subjects continued their ongoing antiretroviral treatment ( ART , Group A ) and 10 were immunized with a HIV-DNA vaccine in addition to their previous therapy ( ART and vaccine , Group B ) .
-METHODS	The genetic vaccine represented HIV-1 subtypes A , B and C , encoded Env , Rev , Gag and RT and had no additional adjuvant .
-METHODS	Immunizations took place at weeks 0 , 4 and 12 , with a boosting dose at week 36 .
-METHODS	Monitoring was performed until week 60 and extended to week 96 .
-RESULTS	Safety data showed good tolerance of the vaccine .
-RESULTS	Adherence to ART remained high and persistent during the study and did not differ significantly between controls and vaccinees .
-RESULTS	Neither group experienced either virological failure or a decline of CD4 + counts from baseline .
-RESULTS	Higher HIV-specific cellular immune responses were noted transiently to Gag but not to other components of the vaccine .
-RESULTS	Lymphoproliferative responses to a virion antigen HIV-1 MN were higher in the vaccinees than in the controls ( p = 0.047 ) , whereas differences in reactivity to clade-specific Gag p24 , RT or Env did not reach significance .
-RESULTS	Compared to baseline , the percentage of HIV-specific CD8 + lymphocytes releasing perforin in the Group B was higher after the vaccination schedule had been completed ( p = 0.031 ) .
-RESULTS	No increased CD8 + perforin levels were observed in control Group A.
-CONCLUSIONS	The present study demonstrates the feasibility , safety and moderate immunogenicity of genetic vaccination in vertically HIV-infected children , paving the way for amplified immunotherapeutic approaches in the pediatric population .
-BACKGROUND	clinicaltrialsregister.eu _ 2007-002359-18IT .
-
-###24500851
-OBJECTIVE	Central venous catheters for maintenance hemodialysis ( HD ) are designed to attain the required dialysis dose through sustained high blood flow rates ( BFR ) .
-OBJECTIVE	The authors studied the immediate and long-term performance and complications of two twin-catheter systems , the Tesio catheter ( TC ) and the LifeCath Twin ( LC ) , to inform clinical practice .
-METHODS	This single-center randomized controlled parallel-group trial allocated 80 incident patients ( 1:1 ) to receive either a TC ( MedComp ) or LC ( Vygon ) .
-METHODS	Patients were dialyzed to target BFR 450 mL/min and followed up for 12 months .
-METHODS	The primary outcome was achievement of target BFR during the first HD session .
-METHODS	Secondary outcomes included thrombotic dysfunction , displacement and catheter-related infection .
-METHODS	Catheter dysfunction was defined by a BFR 250 mL/min .
-RESULTS	More LCs reached the primary endpoint ( 44 % vs. 10 % , p = 0.001 ) delivering a higher BFR ( mean 38382 vs. 27779 mL/min , p < 0.001 ) .
-RESULTS	Significant differences in BFR persisted until the fourth dialysis session .
-RESULTS	Rates of catheter-related bacteremia ( 0.40 vs. 0.51 / 1,000 catheter days , p = 0.7 ) and exit site infection were similar between groups ( 0.24 vs. 0.09 / 1,000 catheter days , p = 0.4 ) .
-RESULTS	Overall rates of catheter dysfunction were 2.8 / 1,000 catheter days ( 95 % CI 2.1-3 .5 ) , with no differences in thrombolytic lock use although the LC group required more thrombolytic infusions ( 6 vs. 0 , p = 0.01 ) .
-CONCLUSIONS	The LC can deliver greater BFRs in the first three HD sessions following insertion although this did not translate into differences in performance , dialysis adequacy or complication rates with long-term use .
-CONCLUSIONS	Both catheter types can consistently deliver high BFRs over an extended period of time .
-
-###25062111
-BACKGROUND	Due to the steady increase of substance-dependent pregnant women the neonatal abstinence syndrome has become an increasingly important issue in neonatology .
-BACKGROUND	The present study investigates site-specific differences of detailed symptoms and treatment of neonatal abstinence syndrome within the context of an international multicenter clinical trial .
-METHODS	Site specific neonatal data analyses from a prospective randomized , double-blind , double-dummy clinical trial ( MOTHER study ) was performed .
-METHODS	A standardized NAS rating and treatment protocol was applied , while non-pharmacological care of NAS symptoms differed across the sites .
-RESULTS	Urban US neonates exhibited most neurological symptoms ( p < 0.001 ) while in Europe autonomous , respiratory and gastrointestinal symptoms were found significantly more often compared to urban and/or rural US ( p < 0.05 ) .
-RESULTS	Methadone produced significantly greater scores than buprenorphine in neurological , behavioural and respiratory symptoms regardless of the sites ( ps < 0.05 ) .
-RESULTS	NAS treatment rates in all site clusters were similar for methadone-exposed neonates , while in Europe significantly more buprenorphine-exposed neonates were treated ( p = 0.001 ) than in US site clusters .
-RESULTS	Urban US neonates had significantly higher NAS scores ( p < 0.01 ) compared to rural US and European neonates , and needed significantly higher morphine doses ( p < 0.05 ) with longer treatment duration .
-RESULTS	Birth weight , length and head circumference did not differ significantly among the site clusters , but APGAR scores were significantly higher in European ( p < 0.01 ) neonates .
-CONCLUSIONS	In addition to intrauterine medication exposure other aspects such as different addiction severity of the mothers , different treatment modalities including rooming-in as well as the frequency of NAS ratings may be influencing the course of NAS .
-
-###24499772
-OBJECTIVE	To determine the degree of dietary adherence or change in eating patterns , and demographic , psychosocial and study characteristics associated with adherence , in the Comparing Healthy Options in Cooking and Eating ( CHOICE ) Study .
-METHODS	Randomized controlled trial where women were randomized to one of three eating patterns : ( i ) Whole Foods , plant-based , macrobiotic-style ( n 22 ) ; and Moderate Fat with ( ii ) , and without ( iii ) , 10 g of ground flaxseed added daily , which were combined ( n 49 ) .
-METHODS	A year-long intervention based on social cognitive theory , consisting of twenty-four class sessions involving hands-on cooking classes and behavioural sessions .
-METHODS	Monthly 24 h food recalls were obtained and a psychosocial questionnaire was administered at baseline , 6 and 12 months .
-METHODS	Healthy , free-living , postmenopausal women .
-RESULTS	A non-adherence score measuring all food servings out-of-compliance with eating pattern recommendations was specifically designed for the present study .
-RESULTS	Non-adherence scores decreased significantly ( P < 005 ) in both groups to about 65 % during the adoption phase ( first 4 months ) and remained so during the 8-month maintenance period .
-RESULTS	Class attendance of the Moderate Fat group showed a trend towards significance as a predictor of adherence ( P = 0063 ) .
-RESULTS	None of the other predictors ( e.g. demographic and psychosocial factors ) in a longitudinal regression model were significant .
-CONCLUSIONS	Postmenopausal women were able to adopt and maintain significant changes in their eating patterns , including those on a demanding , near-vegetarian eating plan , suggesting that behavioural interventions with a healthy free-living population can be effective .
-CONCLUSIONS	The non-adherence score developed for the study provides an example of a means for evaluating eating pattern adherence to a dietary intervention .
-
-###25073669
-OBJECTIVE	Chronic hepatocellular damage is closely associated with hepatic fibrosis and fatal complication in most liver diseases .
-OBJECTIVE	The aim of this study is to compare the efficacy and safety of biphenyl dimethyl dicarboxylate ( DDB ) and ursodeoxycholic acid ( UDCA ) in patients with abnormal ALT .
-METHODS	One-hundred thirty-five patients with elevated ALT were randomized to receive either 750 mg/day of DDB or 300 mg/day of UDCA for 24 weeks in 4 referral hospitals .
-METHODS	Ninety-three ( 69 % ) patients had non-alcoholic steatohepatitits , 27 ( 20 % ) had alcoholic hepatitis , and 15 ( 11 % ) had chronic hepatitis .
-METHODS	The primary end point was the rate of ALT normalization at week 24 .
-METHODS	The secondary endpoints were changes in AST , liver stiffness , and the incidence of adverse events .
-RESULTS	A total of 101 patients completed 24 weeks of therapy .
-RESULTS	ALT normalization at week 24 was observed in 44 ( 80.0 % ) patients in DDB group and 16 ( 34.8 % ) in UDCA group ( p < 0.001 ) .
-RESULTS	Higher mean reduction of ALT levels from baseline to 24 weeks was seen in DDB group compared with UDCA group ( -70.0 % vs. -35.9 % , p < 0.001 ) .
-RESULTS	Normalization of AST level ( p = 0.53 ) and change in the liver stiffness ( p = 0.703 ) were not significantly different between the two groups .
-RESULTS	Severe adverse drug reaction occurred in 1 patient in DDB group but the subject continued therapy during the study period .
-CONCLUSIONS	DDB was not inferior to UDCA for normalizing ALT level .
-CONCLUSIONS	Furthermore it was safe and well tolerated by patients with abnormal ALT .
-
-###25349110
-BACKGROUND	Diabetes mellitus is a healthcare burden in India .
-BACKGROUND	Seventy-four percent of India 's population lives in rural areas with limited access to healthcare resources .
-BACKGROUND	Telemedicine can play a big role in screening people with diabetes at grassroots level .
-BACKGROUND	In the telescreening model , single field 45-degree photographs are used for detecting diabetic retinopathy .
-BACKGROUND	The American Academy of Ophthalmology does not recommends single-field fundus photography as an adequate substitute for a comprehensive ophthalmic examination because it may lead to a higher rate of underdiagnosis .
-BACKGROUND	We conducted a telescreening project using single-field fundus photography to determine its accuracy compared to the traditional camp-based screenings .
-OBJECTIVE	In this project we compared the prevalence of diabetic retinopathy between an ophthalmologist-based and an ophthalmologist-led model on two different samples of people self-reporting with diabetes in rural South India .
-OBJECTIVE	Between 2004 and 2005 in rural South India , 3522 people with diabetes mellitus underwent ophthalmologist-based diabetic retinopathy screening and 4456 people with diabetes underwent ophthalmologist-led ( telescreening ) diabetic retinopathy screening .
-OBJECTIVE	The two population groups were randomly separated .
-OBJECTIVE	In the ophthalmologist-based program , a trained retina specialist travels along with the camp team and screens patients at the camp site for diabetic retinopathy .
-OBJECTIVE	In the ophthalmologist-led program ( telescreening ) , fundus photographs are transmitted to the base hospital for further evaluation and grading .
-OBJECTIVE	A total of 519 people ( 14.7 % ) were diagnosed to have diabetic retinopathy in the ophthalmologist-based model , and 853 people ( 19.1 % ) in the ophthalmologist-led model p < 0.0001 ) .
-OBJECTIVE	More sight-threatening retinopathies were found in the ophthalmologist-led model than in the ophthalmologist-based model ( 6.3 % vs. 5 % ) .
-CONCLUSIONS	The ophthalmologist-led ( telescreening ) model did not underestimate the prevalence of diabetic retinopathy .
-CONCLUSIONS	Therefore , because it obviates the need for travel by an ophthalmologist , it is a good method for diabetic retinopathy screening in rural areas of India .
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-###25012288
-BACKGROUND	Clinical trials traditionally use time-to-first-event analysis embedded within the composite endpoint of cardiovascular death ( CVD ) , myocardial infarction ( MI ) , or stroke .
-BACKGROUND	However , many patients have > 1 event , and this approach may not reflect overall experience .
-BACKGROUND	We addressed this by analyzing all cardiovascular events in TRACER .
-RESULTS	TRACER randomized 12 944 patients with non-ST-segment elevation acute coronary syndromes to placebo or to protease-activated receptor 1 antagonist vorapaxar with a median follow-up of 502 days ( interquartile range , 349 to 667 ) .
-RESULTS	Analysis of vorapaxar 's effect on recurrent CVD , MI , or stroke was prespecified using the Wei , Lin , and Weissfeld approach .
-RESULTS	Vorapaxar did not reduce the first occurrence of the primary endpoint of CVD , MI , stroke , revascularization , or rehospitalization for recurrent ischemia , but reduced the secondary composite endpoint of CVD , MI , or stroke ( 14.7 % vorapaxar vs. 16.4 % placebo ; hazard ratio [ HR ] , 0.89 ; 95 % confidence interval [ CI ] , 0.81 to 0.98 ; P = 0.02 ; number needed to treat [ NNT ] , 81 ) .
-RESULTS	Recurrent secondary events occurred in 2.7 % of patients .
-RESULTS	Vorapaxar reduced overall occurrences of ischemic events , first and subsequent ( HR , 0.88 ; 95 % CI , 0.80 to 0.98 ; P = 0.02 ; NNT , 51 ) .
-RESULTS	Also , there was a trend indicating that vorapaxar reduced the expanded endpoint , including revascularization and rehospitalization for recurrent ischemia ( HR , 0.92 ; 95 % CI , 0.84 to 1.01 ; P = 0.09 ) .
-RESULTS	Vorapaxar increased overall occurrences of moderate and severe Global Use of Strategies to Open Occluded Coronary Arteries bleeding ( HR , 1.42 ; 95 % CI , 1.21 to 1.66 ; P < 0.001 ) and Thrombolysis in Myocardial Infarction clinically significant bleeding ( HR , 1.550 ; 95 % CI , 1.403 to 1.713 ; P < 0.001 ) .
-CONCLUSIONS	Vorapaxar reduced overall occurrences of ischemic events , but increased bleeding .
-CONCLUSIONS	These exploratory findings broaden our understanding of vorapaxar 's potential and expand our understanding of the value of capturing recurrent events .
-BACKGROUND	ClinicalTrials.gov .
-BACKGROUND	Unique identifier : NCT00527943 .
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-###24664539
-BACKGROUND	Application of the capsaicin 8 % patch is associated with treatment-related discomfort .
-BACKGROUND	Consequently , pretreatment for 60min with anaesthetic cream is recommended ; however , this may be uncomfortable and time consuming .
-METHODS	We conducted a multicentre , randomized ( 1:1 ) , assessor-blinded study in patients with peripheral neuropathic pain to assess tolerability of the capsaicin patch following topical lidocaine ( 4 % ) or oral tramadol ( 50mg ) pretreatment .
-METHODS	The primary endpoint was the proportion of patients tolerating capsaicin patch application ( ability to receive 90 % of a 60-min application ) .
-METHODS	Numeric Pain Rating Scale ( NPRS ) scores were assessed before , during and after treatment .
-RESULTS	Overall , 122 patients were included ( 61 per arm ) .
-RESULTS	The capsaicin patch was tolerated by 121 patients .
-RESULTS	Tolerability of the capsaicin patch was similar following pretreatment with lidocaine and tramadol .
-RESULTS	Following patch application , pain levels increased up to 55min ( change from baseline of 1.3 for lidocaine and 1.4 for tramadol ) .
-RESULTS	After patch removal , tramadol-treated patients experienced greater pain relief up to the end of day 1 ; in the evening , mean changes in NPRS scores from baseline were 0 for lidocaine and -1 for tramadol .
-RESULTS	Proportions of patients reporting increases of 2 NPRS points or > 33 % from baseline at one or more time point ( s ) on the day of treatment were similar between arms .
-RESULTS	Adverse event incidence was comparable between arms .
-CONCLUSIONS	Capsaicin 8 % patch tolerability was similar in the two arms , with comparable results for most secondary endpoints .
-CONCLUSIONS	Tramadol given 30min before patch application should be considered as an alternative pretreatment option in patients receiving capsaicin patch treatment .
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-###24273973
-OBJECTIVE	To observe the clinical efficacy of transcutaneous acupoint electrical stimulation ( TAES ) combined intravenous injection and/or Neiguan ( P6 ) injection with droperidol in preventing and treating post-operative nausea and vomiting ( PONV ) after thyroid tumor surgery .
-METHODS	Recruited were 120 female patients who underwent selective thyroid tumor surgery were randomly assigned to the control group , the TAES group , the IV group ( intravenous injection of droperidol ) , and the P6 group [ Neiguan point ( P6 ) injection of droperidol ] , respectively , 30 cases in each group .
-METHODS	Thirty min before anesthesia induction , 2 mL 0.9 % normal saline injection was intravenously injected to those in the control group .
-METHODS	Patients in the TAES group received TEAS at bilateral P6 points .
-METHODS	2.5 mg ( 1 mL ) droperidol added in 1 mL 0.9 normal saline was intravenously injected to those in the IV group and injected at bilateral P6 points of those in the P6 group .
-METHODS	The occurrence and severity of PONV were observed within 0 - 6 h and within 6 - 24 h after operation in each group .
-RESULTS	Compared with the control group , the incidence and the severity of PONV within 0 - 6 h and within 6 - 24 h after thyroid surgery were significantly reduced in the three treatment groups ( P < 0.05 ) .
-RESULTS	There was no statistical difference in the incidence or the severity of PONV among the TAES , IV and P6 groups ( P > 0.05 ) .
-CONCLUSIONS	TEAS at P6 could dramatically reduce the occurrence and the severity of PONV after thyroid tumor surgery .
-CONCLUSIONS	Besides , it got equivalent effect to that by intravenous injecting droperidol or by injecting droperidol at P6 .
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-###24299975
-OBJECTIVE	To reevaluate the role of the antispasmodic drug drotaverine in shortening the length of the active first stage of labor among nulliparous women .
-METHODS	In a randomized , double-blind , placebo-controlled trial , 422 young nulliparous women admitted to Ain-shams University Maternity Hospital , Cairo , Egypt , in spontaneous labor were initially enrolled between May and December 2012 .
-METHODS	Drotaverine hydrochloride ( 40mg ) or placebo was given at the start of the active phase of labor and then repeated every 2hours ( maximum 3 doses ) .
-METHODS	All participants were consistently managed in accordance with the local institutional intrapartum protocol .
-METHODS	The primary outcome was the rate of cervical dilation .
-RESULTS	After excluding women who delivered by cesarean , data were analyzed from 320 women .
-RESULTS	There was a significant difference in post-treatment labor pain scores , duration of the active phase of labor , and rate of cervical dilatation between the 2 groups ( P < 0.001 for all ) .
-RESULTS	There was no difference in maternal adverse effects .
-RESULTS	Kaplan-Meier survival analysis showed a greater probability of faster delivery among patients treated by drotaverine hydrochloride ( log rank test ; P < 0.001 ) .
-CONCLUSIONS	Drotaverine hydrochloride was used effectively and safely to shorten the duration of the first stage of labor among nulliparous women with active spontaneous labor .
-CONCLUSIONS	ClinicalTrials.gov : NCT01639027 .
-
-###24982464
-OBJECTIVE	Relative efficacy and toxicity of cyclophosphamide compared with ifosfamide are debatable .
-OBJECTIVE	The Euro-EWING99-R1 trial asked whether cyclophosphamide may replace ifosfamide in combination with vincristine and dactinomycin ( vincristine , dactinomycin , and cyclophosphamide [ VAC ] v vincristine , dactinomycin , and ifosfamide [ VAI ] ) after an intensive induction chemotherapy containing vincristine , ifosfamide , doxorubicin , and etoposide ( VIDE ) in standard-risk localized disease ( NCT00020566 ) .
-METHODS	Standard-risk Ewing sarcomas were localized tumors with either a good histologic response to chemotherapy ( < 10 % cells ) or small tumors ( < 200 mL ) resected at diagnosis or receiving radiotherapy alone as local treatment .
-METHODS	Patients entered the trial after six VIDE +1 VAI courses .
-METHODS	Allocated treatment was either 7 VAC courses with 1.5 g/m ( 2 ) of cyclophosphamide or seven VAI-courses with 6 g/m ( 2 ) ifosfamide .
-METHODS	The limit of noninferiority was set at -8.5 % for the 3-year event-free survival rate ( EFS ) , equivalent to 1.43 in terms of the hazard ratio of event ( HR ( event ) ) .
-RESULTS	This large international trial recruited 856 patients between February 2000 and March 2010 ( n = 431 receiving VAC and n = 425 receiving VAI ) .
-RESULTS	With a median follow-up of 5.9 years , the 3-year EFSs were 75.4 % and 78.2 % , respectively , the 3-year EFS difference was -2.8 % ( 91.4 % CI , -7.8 to 2.2 % ) , the HR ( event ) was 1.12 ( 91.4 % CI , 0.89 to 1.41 ) , and the HR ( death ) was 1.09 ( 91.4 % CI , 0.84 to 1.42 ; intention-to-treat ) .
-RESULTS	The HR ( event ) was 1.22 ( 91.4 % CI , 0.96 to 1.54 ) on the per-protocol population .
-RESULTS	Major treatment modifications were significantly less frequent in the VAC arm ( < 1 % ) than in the VAI arm ( 7 % ) , mainly resulting from toxicity .
-RESULTS	Patients experienced more frequent thrombocytopenia in the VAC arm ( 45 % v 35 % ) but fewer grade 2 to 4 acute tubular toxicities ( 16 % v 31 % ) .
-CONCLUSIONS	Cyclophosphamide may be able to replace ifosfamide in consolidation treatment of standard-risk Ewing sarcoma .
-CONCLUSIONS	However , some uncertainty surrounding the noninferiority of VAC compared with VAI remains at this stage .
-CONCLUSIONS	The ongoing comparative evaluation of long-term renal and gonadal toxicity is crucial to decisions regarding future patients .
-
-###24391225
-OBJECTIVE	To compare the use of the 810nm diode laser with conventional surgery in the management of soft tissue mucogingival problems associated with orthodontic treatment .
-METHODS	Orthodontic patients requiring different soft tissue surgical procedures were randomly assigned to receive conventional surgery or soft tissue diode laser , ( wavelength 810 nm ) .
-METHODS	Parameters documented include the type of anaesthesia used , intra and post operative pain , bleeding , the use of scalpel and sutures .
-METHODS	The chi-squared test was used to test for significance at 95 % confidence level .
-METHODS	Probability values ( p-values ) less than 0.05 were regarded as significant .
-RESULTS	Only 2 ( 16.7 % ) of the procedures carried out with the soft tissue laser required infiltration anaesthesia compared to 10 ( 90.9 % ) with conventional surgery and this was significant ( P < 0.001 ) .
-RESULTS	Post operative pain was significantly reduced in all cases treated with the diode laser ( P < 0.001 ) .
-RESULTS	There was also a significant difference ( P < 0.05 ) in post operative bleeding in all cases treated with the diode laser .
-RESULTS	No sutures were used in all soft tissue cases managed with the diode laser and this was significant ( P < 0.001 ) .
-RESULTS	There was no statistically significant difference in treatment time in the use of the laser compared with conventional surgery .
-CONCLUSIONS	Orthodontic patients treated with the diode laser required less infiltration anaesthesia , had reduced bleeding during and after surgery , rapid postoperative haemostasis , elimination of the need for sutures and an improved postoperative comfort and healing .
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-###24942553
-OBJECTIVE	Recent data suggest that n-3 PUFA exert beneficial effects on endothelial progenitor cell ( EPC ) biology .
-OBJECTIVE	We sought to investigate whether these effects might be mediated by enhanced EPC in vitro function and/or in vivo bioavailability .
-RESULTS	CACs and late-outgrowth EPCs were isolated from peripheral blood mononuclear cells obtained from 12 donor buffy-coats .
-RESULTS	The effect of n-3 PUFA ( EPA : DHA = 0.9:1.5 ; 9 M EPA plus 15 M DHA ) was tested on CAC/EPC viability , function ( tube-formation ) and pro-inflammatory molecule expression .
-RESULTS	Circulating EPC ( cells positive for CD34 , CD133 and kinase insert domain receptor - KDR cell-surface antigens by flow cytometry ) number was evaluated in 20 healthy subjects ( 10 F/10 M , 32 5 years ) , randomized to receive 4 mackerel or sardine portions per week for 6 weeks followed by a 6 week free-diet period .
-RESULTS	N-3 PUFA improved CAC and late-outgrowth EPC viability ( p < 0.05 ) and the capacity to form tube-like structures in CACs ( +38 % ; p < 0.05 ) and late-outgrowth EPCs ( +15 % ; p < 0.05 ) .
-RESULTS	ICAM-1 expression was reduced in both CACs ( p < 0.05 ) and late-outgrowth EPCs ( p < 0.05 ) and VCAM-1 in late-outgrowth EPCs ( p < 0.005 ) .
-RESULTS	N-3 PUFA significantly decreased TNF - and MCP-1 expression in CACs and IL-8 , TNF - and MCP-1 in late-outgrowth EPCs ( p < 0.05 ) .
-RESULTS	Circulating EPC number significantly improved after 6 weeks of a fish-enriched diet ( p < 0.01 ) and returned to baseline levels after a 6 week free-diet period ( p < 0.01 ) .
-RESULTS	Plasma EPA levels were independently and positively associated with EPC levels ( p < 0.005 ) .
-CONCLUSIONS	Our findings support the case of a beneficiary role played by n-3 PUFA in EPC function and bioavailability .
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-###25057116
-BACKGROUND	Although previous studies have illustrated improvements in surgical cohorts for patients with intervertebral disc herniation , there are limited data on predictors of long-term outcomes comparing surgical and nonsurgical outcomes .
-OBJECTIVE	We assessed outcomes of operative and nonoperative treatment for patients with intervertebral disc herniation and symptomatic radiculopathy at 8years from the Spine Patient Outcomes Research Trial .
-OBJECTIVE	We specifically examined subgroups to determine whether certain populations had a better long-term outcome with surgery or nonoperative treatment .
-METHODS	Patients with symptomatic lumbar radiculopathy for at least 6weeks associated with nerve root irritation or neurologic deficit on examination and a confirmed disc herniation on cross-sectional imaging were enrolled at 13 different clinical sites .
-METHODS	Patients consenting to participate in the randomized cohort were assigned to surgical or nonoperative treatment using variable permuted block randomization stratified by site .
-METHODS	Those who declined randomization entered the observational cohort group based on treatment preference but were otherwise treated and followed identically to the randomized cohort .
-METHODS	Of those in the randomized cohort , 309 of 501 ( 62 % ) provided 8-year data and in the observational group 469 of 743 ( 63 % ) .
-METHODS	Patients were treated with either surgical discectomy or usual nonoperative care .
-METHODS	By 8years , only 148 of 245 ( 60 % ) of those randomized to surgery had undergone surgery , whereas 122 of 256 ( 48 % ) of those randomized to nonoperative treatment had undergone surgery .
-METHODS	The primary outcome measures were SF-36 bodily pain , SF-36 physical function , and Oswestry Disability Index collected at 6weeks , 3months , 6months , 12months , and then annually .
-METHODS	Further analysis studied the following factors to determine if any were predictive of long-term outcomes : sex , herniation location , depression , smoking , work status , other joint problems , herniation level , herniation type , and duration of symptoms .
-RESULTS	The intent-to-treat analysis of the randomized cohort at 8years showed no difference between surgical and nonoperative treatment for the primary outcome measures .
-RESULTS	Secondary outcome measures of sciatica bothersomeness , leg pain , satisfaction with symptoms , and self-rated improvement showed greater improvement in the group randomized to surgery despite high levels of crossover .
-RESULTS	The as-treated analysis of the combined randomized and observational cohorts , adjusted for potential confounders , showed advantages for surgery for all primary outcome measures ; however , this has the potential for confounding from other unrecognized variables .
-RESULTS	Smokers and patients with depression or comorbid joint problems had worse functional outcomes overall ( with surgery and nonoperative care ) but similar surgical treatment effects .
-RESULTS	Patients with sequestered fragments , symptom duration greater than 6months , those with higher levels of low back pain , or who were neither working nor disabled at baseline showed greater surgical treatment effects .
-CONCLUSIONS	The intent-to-treat analysis , which is complicated by high rates of crossover , showed no difference over 8years for primary outcomes of overall pain , physical function , and back-related disability but did show small advantages for secondary outcomes of sciatica bothersomeness , satisfaction with symptoms , and self-rated improvement .
-CONCLUSIONS	Subgroup analyses identified those groups with sequestered fragments on MRI , higher levels of baseline back pain accompanying radiculopathy , a longer duration of symptoms , and those who were neither working nor disabled at baseline with a greater relative advantage from surgery at 8years .
-METHODS	Level II , therapeutic study .
-METHODS	See Instructions for Authors for a complete description of levels of evidence .
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-###24256098
-OBJECTIVE	One of the major challenges in peptic ulcer bleeding ( PUB ) is rebleeding which is associated with up to a fivefold increase in mortality .
-OBJECTIVE	We examined if supplementary transcatheter arterial embolization ( STAE ) performed after achieved endoscopic hemostasis improves outcome in patients with high-risk ulcers .
-METHODS	The study was designed as a non-blinded , parallel group , randomized-controlled trial and performed in a university hospital setting .
-METHODS	Patients admitted with PUB from Forrest Ia - IIb ulcers controlled by endoscopic therapy were randomized ( 1:1 ratio ) to STAE of the bleeding artery within 24 h or continued standard treatment .
-METHODS	Randomization was stratified according to stigmata of hemorrhage .
-METHODS	Patients were followed for 30 days .
-METHODS	Primary outcome was a composite endpoint where patients were classified into five groups based on transfusion requirement , development of rebleeding , need of hemostatic intervention and mortality .
-METHODS	Secondary outcomes were rebleeding , number of blood transfusions received , duration of admission and mortality .
-RESULTS	Totally 105 patients were included .
-RESULTS	Of the 49 patients allocated to STAE 31 underwent successful STAE .
-RESULTS	There was no difference in composite endpoint .
-RESULTS	Two versus eight patients re-bled in the STAE and control group , respectively ( Intention-to-treat analysis ; p = .10 ) .
-RESULTS	After adjustment for possible imbalances a strong trend was noted between STAE and rate of rebleeding ( p = .079 ) .
-CONCLUSIONS	STAE is potentially useful for preventing rebleeding in high-risk PUB .
-CONCLUSIONS	STAE can safely be performed in selected cases with high risk of rebleeding .
-CONCLUSIONS	Further studies are needed in order to confirm these findings ; ClincialTrials.gov number , NCT01125852 .
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-###24881829
-OBJECTIVE	Long-acting reversible contraceptive ( LARC ) methods , such as the intrauterine device and implant , are highly effective but used by less than 10 % of US women .
-OBJECTIVE	The objective of our study was to improve LARC interest by enhancing clinic counseling .
-METHODS	A quality improvement methodology was used to evaluate intrauterine device service delivery in 3 Chicago Title X clinics .
-METHODS	To address identified barriers , we developed a theory-based iOS application ( app ) for patients to use in the clinic waiting room using human-centered design .
-METHODS	The final prototype was tested in a randomized controlled trial in a Title X clinic with sexually active females ( 79 % African American ) under age 30 years .
-METHODS	Our sample of 60 was chosen to detect an increase from 10 % ( baseline ) to 45 % ( app intervention ) in the proportion of patients expressing interest in discussing a LARC method during their clinic visit with 80 % power and two-sided = 0.05 .
-METHODS	After completing demographic and baseline knowledge questionnaires , participants were randomized 1:1 to intervention ( app ) or standard care arms .
-METHODS	App users also completed a posttest .
-METHODS	Our primary outcome was expressed interest in discussing a LARC method during the clinic visit .
-METHODS	Secondary outcomes were contraceptive knowledge and LARC selection .
-RESULTS	App testers ( n = 17 ) preferred interactive , visually appealing design and video testimonials .
-RESULTS	In the pilot randomized controlled trial ( n = 52 ) , app users had a significantly higher knowledge of contraceptive effectiveness ( P = .0001 ) and increased interest in the implant ( 7.1-32 .1 % , P = .02 ) after the intervention .
-RESULTS	Users were highly satisfied with the app .
-RESULTS	Staff reported no problems using the app in the clinic .
-CONCLUSIONS	Use of a theory-based counseling app offers a novel method to optimize wait time while minimizing clinic flow disruption .
-CONCLUSIONS	Preliminary data demonstrate that app use was associated with improvements in patients ' contraceptive knowledge and interest in the implant .
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-###24355438
-OBJECTIVE	Aging is associated with a blunted anabolic response to dietary intake , possibly related to a decrease in systemically available amino acids ( AAs ) , which in turn may stem from increased splanchnic AA metabolism .
-OBJECTIVE	Splanchnic sequestration can be saturated by pulse feeding ( 80 % of daily protein intake in a single meal ) , enabling increased protein synthesis .
-OBJECTIVE	The aim of this study was to explore whether protein pulse feeding increased postprandial AA concentrations , and if so whether this increase persisted after 6 wk of dietary treatment .
-METHODS	This prospective randomized study enrolled 66 elderly malnourished or at-risk patients in an inpatient rehabilitation unit .
-METHODS	All were given a controlled diet for 6 wk .
-METHODS	In a spread diet ( SD ) group ( n = 36 ) , dietary protein was spread over the four daily meals .
-METHODS	In a pulse diet ( PD ) group ( n = 30 ) , 72 % of dietary protein ( averaging 1.31 g/kg body weight daily ) was consumed in one meal at noon .
-METHODS	The patients were evaluated on day 1 and at 6 wk for plasma postprandial ( five times from 0 to +180 min ) AA concentrations ( expressed as area under the curve above baseline ) .
-RESULTS	Protein pulse feeding was more efficient than protein spread feeding at increasing plasma postprandial AA concentrations , notably of essential AAs .
-RESULTS	This increased postprandial AA bioavailability was maintained after 6 wk .
-CONCLUSIONS	This study demonstrates that increased postprandial AA bioavailability induced by protein pulse feeding persists after 6 wk ( i.e. , that there is no metabolic adaptation blunting AA bioavailability ) .
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-###25301763
-BACKGROUND	Transcranial direct current stimulation ( tDCS ) is a non-invasive technique used for modulating cortical excitability in vivo in humans .
-BACKGROUND	Here we evaluated the effect of tDCS on behavioral and electrophysiological aspects of physiological sucking and swallowing .
-METHODS	Twelve healthy subjects underwent three tDCS sessions ( anodal , cathodal and sham stimulation ) on separate days in a double-blind randomized order .
-METHODS	The active electrode was placed over the right swallowing motor cortex .
-METHODS	Repeated sucking and swallowing acts were performed at baseline and at 15 and 60 min after each tDCS session and the mean liquid bolus volume ingested at each time point was measured .
-METHODS	We also calculated average values of the following electrophysiological parameters : 1 ) area and 2 ) duration of the rectified EMG signal from the suprahyoid/submental muscles related to the sucking and swallowing phases ; 3 ) EMG peak amplitude for the sucking and swallowing phases ; 4 ) area and peak amplitude of the laryngeal-pharyngeal mechanogram ; 5 ) oropharyngeal delay .
-RESULTS	The volume of the ingested bolus significantly increased ( by an average of about 30 % compared with the baseline value ) both at 15 and at 60 min after the end of anodal tDCS .
-RESULTS	The electrophysiological evaluation after anodal tDCS showed a significant increase in area and duration of the sucking phase-related EMG signal .
-CONCLUSIONS	Anodal tDCS leads to stronger sucking of a liquid bolus in healthy subjects , likely by increasing recruitment of cortical areas of the swallowing network .
-CONCLUSIONS	This finding might open up interesting perspectives for the treatment of patients suffering from dysphagia due to various pathological conditions .
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-###24642702
-BACKGROUND	The purpose was to test the effectiveness of two transdiagnostic group interventions compared to care as usual ( CAU ) for patients with anxiety , depressive or stress-related disorders within a primary health care context .
-OBJECTIVE	To compare the effects of cognitive-based-behavioural therapy ( CBT ) and multimodal intervention ( MMI ) on the quality of life and relief of psychological symptoms of patients with common mental disorders or problems attending primary health care centre .
-METHODS	Patients ( n = 278 ) , aged 18-65 years , were referred to the study by the GPs and 245 were randomized to CAU or one of two group interventions in addition to CAU : ( i ) group CBT administered by psychologists and ( ii ) group MMI administered by assistant nurses .
-METHODS	The primary outcome measure was the Mental Component Summary score of short form 36 .
-METHODS	Secondary outcome measures were Perceived Stress Scale and Self-Rating Scale for Affective Syndromes .
-METHODS	The data were analysed using intention-to-treat with a linear mixed model .
-RESULTS	On the primary outcome measure , the mean improvement based on mixed model analyses across post - and follow-up assessment was significantly larger for the MMI group than for the CBT ( 4.0 ; P = 0.020 ) and CAU ( 7.5 ; P = .001 ) groups .
-RESULTS	Participants receiving CBT were significantly more improved than those in the CAU group .
-RESULTS	On four of the secondary outcome measures , the MMI group was significantly more improved than the CBT and CAU groups .
-RESULTS	The course of improvement did not differ between the CBT group and the CAU group on these measures .
-CONCLUSIONS	Transdiagnostic group treatment can be effective for patients with common mental disorders when delivered in a primary care setting .
-CONCLUSIONS	The group format and transdiagnostic approach fit well with the requirements of primary care .
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-###25407583
-BACKGROUND	The present study examines the role of comorbid anxiety on depression outcomes for those receiving cognitive behavioral therapy ( CBT ) for depression by telephone ( T-CBT ) or face-to-face ( FtF-CBT ) .
-METHODS	Three hundred twenty-five participants were randomized to T-CBT or FtF-CBT .
-METHODS	Comorbid anxiety was measured using the Mini International Neuropsychiatric Interview and Generalized Anxiety Disorder 7 .
-METHODS	Depression was measured using the Hamilton Rating Scale for Depression and Patient Health Questionnaire 9 .
-RESULTS	A hierarchical model including the two-way interaction of treatment assignment and anxiety status indicated a significant effect for all outcome variables ( Ps < .05 ) .
-RESULTS	Post hoc t tests indicated T-CBT participants with comorbid anxiety disorders had significantly higher symptom severity over time compared to their T-CBT counterparts without anxiety ( Ps < .001 ) and FtF-CBT counterparts with comorbid anxiety ( Ps < .003 ) .
-RESULTS	There were no significant differences in outcomes between those with and without comorbid anxiety disorders receiving FtF-CBT , or between T-CBT and FtF-CBT among those without comorbid anxiety disorders .
-CONCLUSIONS	The findings indicate that the presence of baseline anxiety impacts the overall effect of T-CBT for the treatment of depression .
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-###24588893
-BACKGROUND	Cardiac rehabilitation ( CR ) is a secondary prevention program that offers education and support to assist patients with coronary heart disease ( CHD ) make lifestyle changes .
-BACKGROUND	Despite the benefits of CR , attendance at centre-based sessions remains low .
-BACKGROUND	Mobile technology ( mHealth ) has potential to reach more patients by delivering CR directly to mobile phones , thus providing an alternative to centre-based CR .
-BACKGROUND	The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours ( for example , physically active , fruit and vegetable intake , not smoking , low alcohol consumption ) over and above usual CR services in New Zealand adults diagnosed with CHD .
-METHODS	A two-arm , parallel , randomised controlled trial will be conducted at two Auckland hospitals in New Zealand .
-METHODS	One hundred twenty participants will be randomised to receive a 24-week evidence - and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone ( control ) .
-METHODS	The primary outcome is the proportion of participants adhering to healthy behaviours at 6months , measured using a composite health behaviour score .
-METHODS	Secondary outcomes include overall cardiovascular disease risk , body composition , illness perceptions , self-efficacy , hospital anxiety/depression and medication adherence .
-CONCLUSIONS	This study is one of the first to examine an mHealth-delivered comprehensive CR program .
-CONCLUSIONS	Strengths of the trial include quality research design and in-depth description of the intervention to aid replication .
-CONCLUSIONS	If effective , the trial has potential to augment standard CR practices and to be used as a model for other disease prevention or self-management programs .
-BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12613000901707 .
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-###24832463
-BACKGROUND	Use of TIPSS is associated with increases in ammonia concentration and hepatic encephalopathy ( HE ) risk .
-BACKGROUND	L-ornithine-L-aspartate ( LOLA ) is effective in reducing ammonia concentration .
-OBJECTIVE	To evaluate the effects of LOLA on venous ammonia concentration after TIPSS .
-METHODS	The included patients were randomised to receive LOLA or no-LOLA treatment for 7 days .
-METHODS	Fasting and post-prandial venous ammonia levels were the primary outcomes .
-METHODS	Psychometric performance , post-TIPSS HE , and liver and renal function were assessed as secondary outcomes .
-RESULTS	Of 133 cirrhotic patients who received successful TIPSS between November 2011 and June 2012 , 40 met the inclusion criteria and were randomised to the LOLA ( n = 21 ) or control ( n = 19 ) groups .
-RESULTS	Change in fasting ammonia significantly favoured the LOLA group at days 4 ( P = 0.001 ) and 7 ( P = 0.003 ) .
-RESULTS	Changes in post-prandial ammonia concentration significantly favoured the LOLA group at days 1 , 4 and 7 as well .
-RESULTS	During the study period , patients in the LOLA group had better improvement in psychometric tests than those in the control group .
-RESULTS	Overt HE during treatment was observed in one patient in the LOLA group and three patients in the control group ( P = 0.331 ) .
-RESULTS	There were no differences in complications , adverse events or mortality between the two groups .
-CONCLUSIONS	Prophylactic use of LOLA infusion after TIPSS is safe and effective in significantly reducing the increase of venous ammonia concentration , and can benefit the patient 's mental status as well .
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-###25566704
-BACKGROUND	Median sternotomy , sternal spreading , and sternal wiring are the main causes of pain during the early recovery phase following cardiac surgery .
-OBJECTIVE	This study was designed to evaluate the analgesic efficacy of continuous presternal bupivacaine infusion through a single catheter after parasternal block following cardiac surgery .
-METHODS	The total of 40 patients ( American Society of Anesthesiologist status II , III ) , 45-60 years old , undergoing coronary-artery bypass grafting were enrolled in this prospective , randomized , double-blind study .
-METHODS	A presternal catheter was inserted with continuous infusion of 5 mL/h bupivacaine 0.25 % ( Group B ) or normal saline ( Group C ) during the first 48 postoperative hrs .
-METHODS	Primary outcomes were postoperative morphine requirements and pain scores , secondary outcomes were extubation time , postoperative respiratory parameters , incidence of wound infection , Intensive Care Unit ( ICU ) and hospital stay duration , and bupivacaine level in blood .
-METHODS	Student 's t-test was used to analyze the parametric data and Chi-square test for categorical variables .
-RESULTS	During the postoperative 48 h , there was marked reduction in morphine requirements in Group B compared to Group C , ( 8.6 0.94 mg vs. 18.83 3.4 mg respectively , P = 0.2 ) , lower postoperative pain scores , shorter extubation time ( 117 10 min vs. 195 19 min , respectively , P = 0.03 ) , better respiratory parameters ( PaO 2 / FiO 2 , PaCO 2 and pH ) , with no incidence of wound infection , no differences in ICU or hospital stay duration .
-RESULTS	The plasma concentration of bupivacaine remained below the toxic threshold ( at T24 , 1.2 ug/ml 0.3 and T48 h 1.7 0.3 ug/ml ) .
-CONCLUSIONS	Continuous presternal bupivacaine infusion has resulted in better postoperative analgesia , reduction in morphine requirements , shorter time to extubation , and better postoperative respiratory parameters than the control group .
-
-###24929430
-OBJECTIVE	We investigated the efficacy and safety of the sodium glucose cotransporter 2 inhibitor , empagliflozin , added to multiple daily injections of insulin ( MDI insulin ) in obese patients with type 2 diabetes mellitus ( T2DM ) .
-METHODS	Patients inadequately controlled on MDI insulin metformin ( mean HbA1c 8.3 % [ 67 mmol/mol ] ; BMI 34.8 kg/m ( 2 ) ; insulin dose 92 international units/day ) were randomized and treated with once-daily empagliflozin 10 mg ( n = 186 ) , empagliflozin 25 mg ( n = 189 ) , or placebo ( n = 188 ) for 52 weeks .
-METHODS	Insulin dose was to remain stable in weeks 1-18 , adjusted to meet glucose targets in weeks 19-40 , then stable in weeks 41-52 .
-METHODS	The primary end point was change from baseline in HbA1c at week 18 .
-METHODS	Secondary end points were changes from baseline in insulin dose , weight , and HbA1c at week 52 .
-RESULTS	Adjusted mean SE changes from baseline in HbA1c were -0.50 0.05 % ( -5.5 0.5 mmol/mol ) for placebo versus -0.94 0.05 % ( -10.3 0.5 mmol/mol ) and -1.02 0.05 % ( -11.1 0.5 mmol/mol ) for empagliflozin 10 mg and empagliflozin 25 mg , respectively , at week 18 ( both P < 0.001 ) .
-RESULTS	At week 52 , further reductions with insulin titration resulted in changes from baseline in HbA1c of -0.81 0.08 % ( -8.9 0.9 mmol/mol ) , -1.18 0.08 % ( -12.9 0.9 mmol/mol ) , and -1.27 0.08 % ( -13.9 0.9 mmol/mol ) with placebo , empagliflozin 10 mg , and empagliflozin 25 mg , respectively , and final HbA1c of 7.5 % ( 58 mmol/mol ) , 7.2 % ( 55 mmol/mol ) , and 7.1 % ( 54 mmol/mol ) , respectively .
-RESULTS	More patients attained HbA1c < 7 % ( < 53 mmol/mol ) with empagliflozin ( 31-42 % ) versus placebo ( 21 % ; both P < 0.01 ) .
-RESULTS	Empagliflozin 10 mg and empagliflozin 25 mg reduced insulin doses ( -9 to -11 international units/day ) and weight ( -2.4 to -2.5 kg ) versus placebo ( all P < 0.01 ) at week 52 .
-CONCLUSIONS	In obese , difficult-to-treat patients with T2DM inadequately controlled on high MDI insulin doses , empagliflozin improved glycemic control and reduced weight without increasing the risk of hypoglycemia and with lower insulin requirements .
-
-###24406660
-OBJECTIVE	At present , school-age children suffer high levels of chronic stress that could produce potentially long-lasting effects .
-OBJECTIVE	The aim of this pilot study was to evaluate the effects of mind-body integration practices and cooperative activities on stress levels and social interaction in 7 - to 9-year-old children .
-METHODS	We performed an intervention program once a week during 2 months in which children performed mind-body integration practices and cooperative activities .
-RESULTS	Our findings showed that these practices reduced cortisol levels and increased social connectedness .
-RESULTS	Moreover , we found that most of the children used the learned mind-body integration practices in stressful situations in their homes , even 5 months after the intervention .
-CONCLUSIONS	Our results demonstrated the positive impact of these helpful tools and the great plasticity of children 's behavior , which enabled them to incorporate healthy habits .
-CONCLUSIONS	Overall , the intervention enhanced health at an individual level and favored social network diversity at a group level .
-CONCLUSIONS	Our research illustrates how children can incorporate techniques that help them cope with stressful moments and reveals the effectiveness of this experience in reducing cortisol levels .
-CONCLUSIONS	This study contributes to the understanding of how mind-body integration practices and social connectedness can be helpful in reducing chronic stress , a topic that , to the best of our knowledge , has been little studied in children .
-
-###25006989
-BACKGROUND	Interactions between the microbial flora of the intestine and the human host play a critical role inmaintaining intestinal health and in the pathophysiology of a wide variety of disorders such as antibiotic associated diarrhea , Clostridium difficile infection , and inflammatory bowel disease .
-BACKGROUND	Prebiotics can confer health benefits by beneficial effects on the intestinal microbiome , whereas antibiotics can disrupt the microbiome leading to diarrhea andother side effects .
-OBJECTIVE	To compare the effects of the prebiotic , polysaccharopeptide from Trametes versicolor , to those of the antibiotic , amoxicillin , on the human gut microbiome
-METHODS	Twenty-four healthy volunteers were randomized to receive PSP , amoxicillin , or no treatment ( control ) .
-METHODS	Stool specimens were analyzed using bTEFAP microbial ecology methods on seven occasions over 8 weeks from each participant in the active treatment groups and on three occasions for the controls .
-RESULTS	Twenty-two of 24 participants completed the protocol .
-RESULTS	PSP led to clear and consistent microbiome changes consistent with its activity as a prebiotic .
-RESULTS	Despite the diversity of the human microbiome we noted strong microbiome clustering among subjects .
-RESULTS	Baseline microbiomes tended to remain stable and to overshadow the treatment effects.Amoxicillin treatment caused substantial microbiome changes most notably an increase in Escherichia/Shigella .
-RESULTS	Antibiotic associated changes persisted to the end of the study , 42 days after antibiotic therapy ended .
-CONCLUSIONS	The microbiomes of healthy individuals show substantial diversity but remain stable over time.The antibiotic amoxicillin alters the microbiome and recovery from this disruption can take several weeks .
-CONCLUSIONS	PSP from T. versicolor acts as a prebiotic to modulate human intestinal microbiome composition .
-
-###25286703
-OBJECTIVE	To determine the feasibility and clinical efficacy of ultrasound-guided facet joint injection and nerve block in lumbar facet joint for the treatment of facet-joint related low back pain .
-METHODS	20 patients with facet-joint pain were randomized into two groups received block blindly ( B group ) or guided by ultrasound ( US group ) respectively .
-METHODS	The location of needle tip was confirmed by CT in both groups , and the accuracy was computed afterwards .
-METHODS	VAS score , puncture time and one-time puncture success rate ( % ) were recorded .
-METHODS	VAS scores and pain remission rates in both groups were recorded at 30 min , 1 d , 2 d , 6 weeks after the block .
-RESULTS	The VAS scores were 3.3 + / - 0.4 in US group and 1.2 + / - 0.3 in B group ( P < 0.05 ) .
-RESULTS	The puncture time was ( 206 + / - 27 ) s in US group while ( 397 + / - 31 ) s in B group ( P < 0.05 ) .
-RESULTS	There were 37 facet joint blocks guided by ultrasound , in which 32 were correctly targeted with the first puncture .
-RESULTS	The success rate is 86.5 % .
-RESULTS	There were 35 facet joint blocks blindly , in which 11 were correctly targeted with the first puncture .
-RESULTS	The success rate is 31.4 % .
-RESULTS	The difference of one-time puncture success rate between the two groups was significant ( P < 0.05 ) .
-RESULTS	Differences of VAS and pain remission rate at half an hour after facet joint injection between B group and US group were significant ( P < 0.05 ) .
-RESULTS	There were 8 , 9 , 9 , and 9 patients in US group obtaining a reduction in VAS scores > or = 3 at 30 min , 1 d , 2 d and 6 weeks after the procedure respectively , while the numbers of such patients were 5 , 6 , 5 , 5 in B group ( P > 0.05 ) .
-RESULTS	After 6 weeks of follow-up , the overall remission rates were ( 72.3 + / - 14.0 ) % in US group , and ( 56.7 + / - 11.0 ) % in B group , there was no significant difference between the two groups ( P > 0.05 ) .
-CONCLUSIONS	The ultrasound-guided lumbar facet joint injection technique had a high feasibility and accuracy , and had better clinical efficacy than block blindly .
-
-###25607727
-OBJECTIVE	Depression is prevalent and associated with negative outcomes in individuals with spinal cord injury ( SCI ) .
-OBJECTIVE	Antidepressants are used routinely to treat depression , yet no placebo-controlled trials have been published in this population to our knowledge .
-OBJECTIVE	To determine the efficacy and tolerability of venlafaxine hydrochloride extended-release ( XR ) for major depressive disorder ( MDD ) or dysthymic disorder in persons with chronic SCI .
-METHODS	Multisite , randomized ( 1:1 ) , double-blind , placebo-controlled Project to Improve Symptoms and Mood After SCI ( PRISMS ) trial .
-METHODS	All research staff conducting screening , intervention , and outcome procedures were blinded to randomization status .
-METHODS	We screened 2536 patients from outpatient clinics at 6 SCI treatment centers in the United States and randomized 133 participants into the trial .
-METHODS	Participants were 18 to 64 years old and at least 1 month after SCI , with MDD or dysthymic disorder .
-METHODS	Seventy-four percent of participants were male , and participants were on average 40 years old and 11 years after SCI .
-METHODS	Forty-seven percent had cervical injuries , 53.4 % had American Spinal Injury Association injury severity A ( complete injury ) SCI , 24.1 % had at least 2 prior MDD episodes , and 99.2 % had current MDD .
-METHODS	Common comorbidities included chronic pain ( 93.9 % ) , significant anxiety ( 57.1 % ) , and history of substance dependence ( 44.4 % ) .
-METHODS	Twelve-week trial of venlafaxine XR vs placebo using a flexible-dose algorithm .
-METHODS	The Hamilton Depression Rating Scale ( HAM-D 17-item version and Maier subscale , which focuses on core depression symptoms and excludes somatic symptoms ) over 12 weeks .
-RESULTS	Mixed-effects models revealed a significant difference between the venlafaxine XR and placebo groups in improvement on the Maier subscale from baseline to 12 weeks ( treatment effect , 1.6 ; 95 % CI , 0.3-2 .9 ; P = .02 ) but not on the HAM-D 17-item version ( treatment effect , 1.0 ; 95 % CI , -1.4 to 3.4 ; P = .42 ) .
-RESULTS	Participants receiving venlafaxine XR reported significantly less SCI-related disability on the Sheehan Disability Scale at 12 weeks compared with placebo ( treatment effect , 4.7 ; 95 % CI , 1.5-7 .8 ; P = .005 ) .
-RESULTS	Blurred vision was the only significantly more common new or worsening adverse effect in the venlafaxine XR group compared with the placebo group over 12 weeks .
-CONCLUSIONS	Venlafaxine XR was well tolerated by most patients and an effective antidepressant for decreasing core symptoms of depression and improving SCI-related disability .
-CONCLUSIONS	Further research is needed to determine the optimal treatment and measurement approaches for depression in chronic SCI .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00592384 .
-
-###26305648
-OBJECTIVE	Epidemiological evidence suggests that physical activity benefits cognition , but results from randomized trials are limited and mixed .
-OBJECTIVE	To determine whether a 24-month physical activity program results in better cognitive function , lower risk of mild cognitive impairment ( MCI ) or dementia , or both , compared with a health education program .
-METHODS	A randomized clinical trial , the Lifestyle Interventions and Independence for Elders ( LIFE ) study , enrolled 1635 community-living participants at 8 US centers from February 2010 until December 2011 .
-METHODS	Participants were sedentary adults aged 70 to 89 years who were at risk for mobility disability but able to walk 400 m.
-METHODS	A structured , moderate-intensity physical activity program ( n = 818 ) that included walking , resistance training , and flexibility exercises or a health education program ( n = 817 ) of educational workshops and upper-extremity stretching .
-METHODS	Prespecified secondary outcomes of the LIFE study included cognitive function measured by the Digit Symbol Coding ( DSC ) task subtest of the Wechsler Adult Intelligence Scale ( score range : 0-133 ; higher scores indicate better function ) and the revised Hopkins Verbal Learning Test ( HVLT-R ; 12-item word list recall task ) assessed in 1476 participants ( 90.3 % ) .
-METHODS	Tertiary outcomes included global and executive cognitive function and incident MCI or dementia at 24 months .
-RESULTS	At 24 months , DSC task and HVLT-R scores ( adjusted for clinic site , sex , and baseline values ) were not different between groups .
-RESULTS	The mean DSC task scores were 46.26 points for the physical activity group vs 46.28 for the health education group ( mean difference , -0.01 points [ 95 % CI , -0.80 to 0.77 points ] , P = .97 ) .
-RESULTS	The mean HVLT-R delayed recall scores were 7.22 for the physical activity group vs 7.25 for the health education group ( mean difference , -0.03 words [ 95 % CI , -0.29 to 0.24 words ] , P = .84 ) .
-RESULTS	No differences for any other cognitive or composite measures were observed .
-RESULTS	Participants in the physical activity group who were 80 years or older ( n = 307 ) and those with poorer baseline physical performance ( n = 328 ) had better changes in executive function composite scores compared with the health education group ( P = .01 for interaction for both comparisons ) .
-RESULTS	Incident MCI or dementia occurred in 98 participants ( 13.2 % ) in the physical activity group and 91 participants ( 12.1 % ) in the health education group ( odds ratio , 1.08 [ 95 % CI , 0.80 to 1.46 ] ) .
-CONCLUSIONS	Among sedentary older adults , a 24-month moderate-intensity physical activity program compared with a health education program did not result in improvements in global or domain-specific cognitive function .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01072500 .
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-###24893325
-OBJECTIVE	To evaluate the effect of expert guided mentorship on technical score and time for a set of robotic training drills .
-METHODS	Prospective randomized controlled trial ( Canadian Task Force classification I ) .
-METHODS	Academic institution .
-METHODS	Fifty trainees in robotic surgery .
-METHODS	Inexperienced trainees underwent either a 20-minute expert guided mentorship session or no intervention .
-METHODS	The primary outcomes were technical score and time-to-drill completion for a set of dry lab robotic training drills evaluated at an initial and final skills assessment .
-METHODS	The t-test , including paired analyses , was used to evaluate outcomes .
-RESULTS	Forty-nine of 50 trainees ( 98 % ) completed the study .
-RESULTS	There were no significant differences in participant characteristics or initial performance between the 2 groups .
-RESULTS	During the final skills assessment , the intervention group demonstrated significantly better performance on 1 of 8 objective measures .
-RESULTS	They had a higher mean score for the bead transfer drill when compared with the control group ( 21.6 vs 19.9 ; p = .03 ) .
-RESULTS	No differences in time-to-drill completion were noted between the 2 groups .
-RESULTS	Regardless of randomization , all participants had significantly improved scores for each of the drills on the final compared with the initial skills assessment ( p < .01 ) .
-CONCLUSIONS	Although expert guided mentorship in a dry lab simulation environment seems feasible , further investigation is warranted before its widespread use because it may be more resource intensive than other teaching methods , without consistent objective improvements in technical performance .
-
-###24824629
-OBJECTIVE	Lithium has been widely used to treat bipolar affective disorder for over 60years .
-OBJECTIVE	Still , its acute effects in human cerebral cortex are poorly understood .
-OBJECTIVE	This study aimed at investigating the acute effects of lithium on motor cortex excitability as measured by transcranial magnetic stimulation ( TMS ) .
-METHODS	Ten healthy young adults participated in a double-blind placebo-controlled randomized crossover study with four sessions , where a single oral dose of lithium carbonate ( 450mg , 900mg , or 1350mg ) or placebo was tested .
-METHODS	Focal TMS of the hand area of left motor cortex was used to test resting and active motor thresholds , motor evoked potential input-output curve ( MEP IO-curve ) , slope of the MEP IO-curve and paired-pulse measures of intracortical inhibition and facilitation before , and two and four hours after drug administration .
-RESULTS	Two hours post drug administration , 450mg of lithium carbonate increased the slope of the MEP IO-curve while 1350mg tended to decrease it .
-RESULTS	Lithium had no effect on motor thresholds , or intracortical inhibition or facilitation .
-CONCLUSIONS	The acute effects of lithium on MEP IO-curve , a marker of corticospinal excitability , are consistent with an inverted U-shaped dose-response relationship .
-CONCLUSIONS	Findings are important for our understanding of the therapeutic and toxic effects of lithium on the human central nervous system .
-
-###25549827
-BACKGROUND	The rising number of children in daycare nurseries increases opportunities for the transmission of infectious diseases .
-BACKGROUND	Pathogens may be transmitted directly from child to child via sneezing , coughing and touching , or indirectly via the environment .
-BACKGROUND	Toys are among the fomites with the highest pathogen load , but their role in disease transmission is unknown .
-OBJECTIVE	To determine if washing and disinfection of toys can reduce sickness absence and microbial pathogen load in the nursery environment .
-METHODS	Twelve nurseries ( caring for 587 children ) were randomized to intervention and control groups .
-METHODS	The intervention consisted of washing and disinfection of toys and linen every two weeks for three months by a commercial cleaning company .
-METHODS	The extent and causes of sickness absence among the children were recorded in both groups before and after introduction of the intervention .
-METHODS	Ten sampling points in each nursery were examined for bacteria and respiratory viruses .
-RESULTS	The presence of respiratory virus DNA/RNA was widespread , but very few pathogenic bacteria were found in the environment .
-RESULTS	The intervention reduced the presence of adenovirus [ odds ratio ( OR ) 2.4 , 95 % confidence interval ( CI ) 1.1-5 .0 ] , rhinovirus ( OR 5.3 , 95 % CI 2.3-12 .4 ) and respiratory syncytial virus ( OR 4.1 , 95 % CI 1.5-11 .2 ) compared with the control group , but the intervention had no effect on sickness absence or disease patterns in the nurseries .
-CONCLUSIONS	Although cleaning and disinfection of toys every two weeks can decrease the microbial load in nurseries , it does not appear to reduce sickness absence among nursery children .
-
-###25237065
-BACKGROUND	Acute kidney injury ( AKI ) remains a deadly condition .
-BACKGROUND	Tissue inhibitor of metalloproteinases ( TIMP ) -2 and insulin-like growth factor binding protein ( IGFBP ) 7 are two recently discovered urinary biomarkers for AKI .
-BACKGROUND	We now report on the development , and diagnostic accuracy of two clinical cutoffs for a test using these markers .
-METHODS	We derived cutoffs based on sensitivity and specificity for prediction of Kidney Disease : Improving Global Outcomes Stages 2-3 AKI within 12 h using data from a previously published multicenter cohort ( Sapphire ) .
-METHODS	Next , we verified these cutoffs in a new study ( Opal ) enrolling 154 critically ill adults from six sites in the USA .
-RESULTS	One hundred subjects ( 14 % ) in Sapphire and 27 ( 18 % ) in Opal met the primary end point .
-RESULTS	The results of the Opal study replicated those of Sapphire .
-RESULTS	Relative risk ( 95 % CI ) in both studies for subjects testing at 0.3 versus > 0.3-2 were 4.7 ( 1.5-16 ) and 4.4 ( 2.5-8 .7 ) , or 12 ( 4.2-40 ) and 18 ( 10-37 ) for 0.3 versus > 2 .
-RESULTS	For the 0.3 cutoff , sensitivity was 89 % in both studies , and specificity 50 and 53 % .
-RESULTS	For 2.0 , sensitivity was 42 and 44 % , and specificity 95 and 90 % .
-CONCLUSIONS	Urinary [ TIMP-2 ] [ IGFBP7 ] values of 0.3 or greater identify patients at high risk and those > 2 at highest risk for AKI and provide new information to support clinical decision-making .
-BACKGROUND	Clintrials.gov # NCT01209169 ( Sapphire ) and NCT01846884 ( Opal ) .
-
-###25356053
-OBJECTIVE	To study the effect of somatostatin in patients with advanced gastric cancer who received D2 lymphadenectomy and vagina vasorum dissection .
-METHODS	Using a prospective , single-blind , placebo-controlled design , patients with advanced gastric cancer were randomized into a study group ( n = 61 ) and a control group ( n = 59 ) .
-METHODS	Patients in the study group were given somatostatin for 5-7 d starting 6 h after the operation , and patients in the control group were given normal saline .
-METHODS	Preoperative and nonoperative complications in the perioperative period , as well as different types of postoperative drainage in the two groups were compared .
-RESULTS	There was no significant difference between the study group and the control group for preoperative clinicopathological indicators .
-RESULTS	We found no significant difference between the two groups for the overall incidence of complications , but a lower percentage of peritoneal effusion was observed in the treatment group ( 1.6 % vs 10.2 % , P < 0.05 ) .
-RESULTS	There were no significant differences between the two groups in the incidence of postoperative pancreatic dysfunction and chylous fistula .
-RESULTS	However , there were significant differences in the amylase concentration in drainage fluid , volume and duration of drainage , volume and duration of chylous fistula and peritoneal drainage , and volume and duration of gastric tube drainage .
-RESULTS	The study group did not show any increase in mean hospitalization cost and the cost reduced when the postoperative complications occurred .
-CONCLUSIONS	Postoperative somatostatin reduces volume and duration of surgical drainage and related complications .
-CONCLUSIONS	Somatostatin may improve safety of gastric cancer surgery , reducing postoperative complications and promoting recovery .
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-###26092818
-BACKGROUND	mTOR inhibition reverses trastuzumab resistance via the hyperactivated PIK/AKT/mTOR pathway due to PTEN loss , by sensitising PTEN-deficient tumours to trastuzumab .
-BACKGROUND	The BOLERO-1 study assessed the efficacy and safety of adding everolimus to trastuzumab and paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer .
-METHODS	In this phase 3 , randomised , double-blind trial , patients were enrolled across 141 sites in 28 countries .
-METHODS	Eligible patients were aged 18 years or older , with locally assessed HER2-positive advanced breast cancer , with Eastern Cooperative Oncology Group ( ECOG ) performance status of 0-1 , who had not received previous trastuzumab or chemotherapy for advanced breast cancer within 12 months of randomisation , had measurable disease as per Response Evaluation Criteria in Solid Tumors ( RECIST ) or bone lesions in the absence of measurable disease , without previous systemic treatment for advanced disease except endocrine therapy .
-METHODS	Patients were randomly assigned ( 2:1 ) with an interactive voice and web response system to receive either 10 mg everolimus once a day orally or placebo plus weekly trastuzumab intravenously at 4 mg/kg loading dose on day 1 with subsequent weekly doses of 2 mg/kg of each 4 week cycle plus paclitaxel intravenously at a dose of 80 mg/m ( 2 ) on days 1 , 8 , and 15 of each 4 week cycle .
-METHODS	Randomisation was stratified according to previous use of trastuzumab and visceral metastasis .
-METHODS	Patients and investigators were masked to the assigned treatments .
-METHODS	Identity of experimental treatments was concealed by use of everolimus and placebo that were identical in packaging , labelling , appearance , and administration schedule .
-METHODS	The two primary objectives were investigator-assessed progression-free survival in the full study population and in the subset of patients with hormone receptor-negative breast cancer at baseline ; the latter was added during the course of the study , before unmasking based on new clinical and biological findings from other studies .
-METHODS	All efficacy analyses were based on the intention-to-treat population .
-METHODS	Enrolment for this trial is closed and results of the final progression-free survival analyses are presented here .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT00876395 .
-RESULTS	Between Sept 10 , 2009 , and Dec 16 , 2012 , 719 patients were randomly assigned to receive everolimus ( n = 480 ) or placebo ( n = 239 ) .
-RESULTS	Median follow-up was 413 months ( IQR 354-466 ) .
-RESULTS	In the full population , median progression-free survival was 1495 months ( 95 % CI 1455-1791 ) with everolimus versus 1449 months ( 1229-1708 ) with placebo ( hazard ratio 089 , 95 % CI 073-108 ; p = 01166 ) .
-RESULTS	In the HR-negative subpopulation ( n = 311 ) , median progression-free survival with everolimus was 2027 months ( 95 % CI 1495-2408 ) versus 1308 months ( 1005-1656 ) with placebo ( hazard ratio 066 , 95 % CI 048-091 ; p = 00049 ) ; however , the protocol-specified significance threshold ( p = 00044 ) was not crossed .
-RESULTS	The most common adverse events with everolimus were stomatitis ( 314 [ 67 % ] of 472 patients in the everolimus group vs 77 [ 32 % ] of 238 patients in the placebo group ) , diarrhoea ( 267 [ 57 % ] vs 111 [ 47 % ] patients ) , and alopecia ( 221 [ 47 % ] vs 125 [ 53 % ] ) .
-RESULTS	The most frequently reported grade 3 or 4 adverse events in the everolimus group versus the placebo group were neutropenia ( 117 [ 25 % ] vs 35 [ 15 % ] ) , stomatitis ( 59 [ 13 % ] vs three [ 1 % ] ) , anaemia ( 46 [ 10 % ] vs six [ 3 % ] ) and diarrhoea ( 43 [ 9 % ] vs 10 [ 4 % ] ) On-treatment adverse event-related deaths were reported in 17 ( 4 % ) patients in the everolimus group and none in the placebo group .
-CONCLUSIONS	Although progression-free survival was not significantly different between groups in the full analysis population , the 72 months prolongation we noted with the addition of everolimus in the HR-negative , HER2-positive population warrants further investigation , even if it did not meet prespecified criteria for significance .
-CONCLUSIONS	The safety profile was generally consistent with what was previously reported in BOLERO-3 .
-CONCLUSIONS	Proactive monitoring and early management of adverse events in patients given everolimus and chemotherapy is crucial .
-BACKGROUND	Novartis Pharmaceuticals .
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-###25491621
-OBJECTIVE	To explore the selective retention of the great saphenous vein trunk below the knee to prevent saphenous nerve injury during varicose vein surgery .
-METHODS	This research was a single-center prospective randomized trial .
-METHODS	From January 2009 to January 2012 , 280 patients of varicose veins in the great saphenous vein were treated and divided into two groups of 140 cases each .
-METHODS	In the observation group , the vascular trunk of the great saphenous vein was stripped to below the knee level whilst that in the control group , it was stripped to the ankle level .
-METHODS	Patients in both groups were treated with a transilluminated powered phlebectomy ( TIPP ) and foam sclerotherapy .
-METHODS	Primary end points were postoperative pain , saphenous nerve injury , quality of life and recurrence rate .
-RESULTS	After one month follow-up : 5.71 % of patients in the observation group had neurological symptoms , while 14.29 % of patients had neurological symptoms in the control group .
-RESULTS	The saphenous nerve injury between the two groups was statistically significant .
-RESULTS	Postoperative follow-up of one year , 1.47 % patients had symptoms of neurological disorders in the observation group , while 7.14 % patients had symptoms of neurological disorders in the control group .
-RESULTS	The saphenous nerve injury between the two groups was statistically significant .
-RESULTS	Therefore , selective retention of great saphenous vein below-knee can prevent saphenous nerve injury .
-RESULTS	The main outcome measures were postoperative pain , missing saphenous nerve , improvement of symptoms and the incidence of recurrence .
-RESULTS	The follow-up after one month showed that the percentage of neurological symptoms in the observation group and the control group was 5.71 % and 14.29 % respectively , and the saphenous nerve injury showed a statistical difference .
-RESULTS	The follow-up after one year showed 1.47 % of abnormal sensation in the observation group and 7.14 % of dysesthesia or paresthesia in the control group in surgical limb according to subjects ' claims , and there existed a statistical difference in the saphenous nerve injury .
-CONCLUSIONS	The selective retention of the great saphenous vein trunk below the knee can prevent the saphenous nerve injury .
-
-###24725910
-BACKGROUND	Shared decision making is a promising model for patient-centred medicine , resulting in better clinical outcomes overall .
-BACKGROUND	In the mental health field , interventions that consider the patient-centred perspective -- such as patient quality of life , involvement in the treatment , treatment satisfaction , and working alliance -- have increased and better clinical outcomes discovered for patients with schizophrenia .
-BACKGROUND	However , few studies have examined the efficacy of shared decision making for schizophrenia treatment .
-BACKGROUND	The objective of this study is to evaluate the effect of a shared decision making intervention compared to treatment as usual on patient satisfaction at discharge for first-admission patients with schizophrenia .
-METHODS	This is a randomised , parallel-group , two-arm , open-label , single-centre study currently being conducted in an acute psychiatric ward of Numazu Chuo Hospital , Japan .
-METHODS	We are recruiting patients between 16 and 65 years old who are admitted to the ward with a diagnosis of schizophrenia without prior experience of psychiatric admission .
-METHODS	Fifty-eight participants are being randomised into a shared decision making intervention group or a treatment as usual control group in a 1:1 ratio .
-METHODS	The intervention program was developed based on a shared decision making model and is presented as a weekly course lasting the duration of the patients ' acute psychiatric ward stay .
-METHODS	The primary outcome measure is patient satisfaction at discharge as assessed by the Client Satisfaction Questionnaire .
-METHODS	Due to the study 's nature , neither the patient nor staff can be blinded .
-CONCLUSIONS	This is the first randomised controlled trial to evaluate the efficacy of shared decision making for patients with early-treatment-stage schizophrenia .
-CONCLUSIONS	The intervention program in this study is innovative in that it includes both of the patient and staff who are involved in the treatment .
-BACKGROUND	The study has been registered with ClinicalTrials.gov as NCT01869660 .
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-###24652467
-OBJECTIVE	Orbital inflammation is a potentially blinding and disfiguring disease process that is often treated with systemic corticosteroids and immunosuppression ; better treatments are needed .
-OBJECTIVE	To determine whether rituximab , a monoclonal antibody against the B-lymphocyte antigen CD20 , is effective in the treatment of refractory orbital inflammation .
-METHODS	A dose-ranging , randomized , double-masked phase 1/2 clinical trial was conducted at a tertiary referral ophthalmology clinic .
-METHODS	Ten individuals with orbital inflammation refractory to systemic corticosteroids and at least 1 other immunosuppressive agent were enrolled from January 2007 to March 2010 .
-METHODS	Rituximab infusions were administered on study days 1 and 15 at doses of either 500 mg or 1000 mg .
-METHODS	Initial responders with recurrent inflammation after week 24 were permitted reinfusion with an additional cycle of 2 open-label 1000-mg rituximab infusions .
-METHODS	The primary outcomes were reduction of inflammation measured with a validated orbital disease grading scale and corticosteroid dose reduction by at least 50 % .
-METHODS	The secondary outcomes were visual acuity , reduction in pain , and participant - and physician-reported global health assessment .
-RESULTS	Of 10 enrolled patients , 7 demonstrated improvement on the orbital disease grading scale at the 24-week end point with rituximab therapy .
-RESULTS	Of these 7 individuals , 4 were receiving corticosteroids at study inception and all achieved successful dose reduction .
-RESULTS	For the secondary outcome measures in the 10 participants , 7 patients and 8 patients improved in self-rated and physician global health scores , respectively , and 7 patients had reduction in pain by 25 % or more at 24 weeks .
-RESULTS	Four patients who were positive responders at the week 24 end point experienced breakthrough inflammation after week 24 and received reinfusions between 24 and 48 weeks .
-RESULTS	Vision remained stable in all participants .
-RESULTS	Three of 10 patients had short-term objective or subjective worsening 2 to 8 weeks after receiving rituximab infusions , which was averted in subsequent patients with oral corticosteroids administered during the infusion and did not affect the eventual positive treatment outcome .
-RESULTS	No significant differences with regard to efficacy , toxicity , or likelihood of retreatment were noted between the dosing arms .
-CONCLUSIONS	Rituximab was safe and effective in 7 of 10 patients with noninfectious orbital disease , although 4 required reinfusion with rituximab to maintain control of orbital inflammation .
-CONCLUSIONS	Substantial toxicity was not noted .
-CONCLUSIONS	Rituximab should be considered in the treatment of refractory orbital inflammation .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00415506 .
-
-###25981191
-BACKGROUND	The most prevalent phenotype of asthma is characterized by eosinophil-dominated inflammation that is driven by a type 2 helper T cell ( Th2 ) .
-BACKGROUND	Therapeutic targeting of GATA3 , an important transcription factor of the Th2 pathway , may be beneficial .
-BACKGROUND	We evaluated the safety and efficacy of SB010 , a novel DNA enzyme ( DNAzyme ) that is able to cleave and inactivate GATA3 messenger RNA ( mRNA ) .
-METHODS	We conducted a randomized , double-blind , placebo-controlled , multicenter clinical trial of SB010 involving patients who had allergic asthma with sputum eosinophilia and who also had biphasic early and late asthmatic responses after laboratory-based allergen provocation .
-METHODS	A total of 40 patients could be evaluated ; 21 were assigned to receive 10 mg of SB010 , and 19 were assigned to receive placebo , with each study drug administered by means of inhalation once daily for 28 days .
-METHODS	An allergen challenge was performed before and after the 28-day period .
-METHODS	The primary end point was the late asthmatic response as quantified by the change in the area under the curve ( AUC ) for forced expiratory volume in 1 second ( FEV1 ) .
-RESULTS	After 28 days , SB010 attenuated the mean late asthmatic response by 34 % , as compared with the baseline response , according to the AUC for FEV1 , whereas placebo was associated with a 1 % increase in the AUC for FEV1 ( P = 0.02 ) .
-RESULTS	The early asthmatic response with SB010 was attenuated by 11 % as measured by the AUC for FEV1 , whereas the early response with placebo was increased by 10 % ( P = 0.03 ) .
-RESULTS	Inhibition of the late asthmatic response by SB010 was associated with attenuation of allergen-induced sputum eosinophilia and with lower levels of tryptase in sputum and lower plasma levels of interleukin-5 .
-RESULTS	Allergen-induced levels of fractional exhaled nitric oxide and airway hyperresponsiveness to methacholine were not affected by either SB010 or placebo .
-CONCLUSIONS	Treatment with SB010 significantly attenuated both late and early asthmatic responses after allergen provocation in patients with allergic asthma .
-CONCLUSIONS	Biomarker analysis showed an attenuation of Th2-regulated inflammatory responses .
-CONCLUSIONS	( Funded by Sterna Biologicals and the German Federal Ministry of Education and Research ; ClinicalTrials.gov number , NCT01743768 . )
-
-###24276460
-BACKGROUND	Odanacatib is a cathepsin K inhibitor in development for the treatment of osteoporosis .
-BACKGROUND	Evaluation of therapies to ensure that treatment effects are relevant regardless of sex is clinically important .
-METHODS	In this double-blind , randomized controlled trial , older men ( aged 50-75 years ) and postmenopausal women ( aged 45-75 years ) were given odanacatib 50 mg once weekly or placebo for 4 weeks .
-METHODS	Pharmacodynamic ( PD ) evaluation measured weighted average inhibition ( WAI ) of urine amino-terminal cross-linked telopeptide of type I collagen/creatinine ( uNTx/Cr ) after odanacatib administration .
-METHODS	Pharmacokinetic ( PK ) parameter data were collected , and an analysis of sex as a factor in the PK/PD relationship was conducted .
-METHODS	Adverse events were monitored .
-METHODS	The hypotheses were that WAI of uNTx/Cr would be > 40 % ( including > 40 % for the lower limit of the 90 % confidence intervals [ CIs ] ) for older men and postmenopausal women , that there would be no important differences in area under the curve from 0 to 168 hours ( AUC0-168 h ) between men and women , and that odanacatib would be safe and well tolerated .
-RESULTS	A total of 44 subjects ( 32 men and 12 women ) were randomized .
-RESULTS	The least squares mean WAI ( uNTx/Cr ) at week 4 was 42.8 % ( 90 % CI , 35.5 % -49.3 % ) for men and 42.7 % ( 90 % CI , 30.3 % -52.9 % ) for women ; mean values were > 40 % , but lower bounds were < 40 % as prespecified in the primary hypothesis .
-RESULTS	The differences among men and women in PD parameters were not meaningful ( 0.1 ; 90 % CI , -14.7 to 14.9 ) .
-RESULTS	PK parameters for both groups were comparable ( geometric mean ratio of AUC0-168 h , 0.90 ; 90 % CI , 0.75-1 .07 ) .
-RESULTS	A PK/PD analysis found that the EC50 and maximum fractional inhibition were similar in male and female subjects .
-RESULTS	There were no notable or serious adverse events in this study .
-CONCLUSIONS	Although the primary hypothesis was not met , there were no clinically meaningful differences in PD , PK , or PK/PD parameters between older men and postmenopausal women , supporting further research on odanacatib ( 50 mg once weekly ) as a treatment for male osteoporosis .
-CONCLUSIONS	Odanacatib was generally well tolerated .
-
-###24949937
-OBJECTIVE	To explore relationships between baseline and changes in fatigue during treatment with outcomes in patients with major depressive disorder ( MDD ) receiving citalopram monotherapy .
-METHODS	Secondary analyses of data from the Sequenced Treatment Alternatives to Relieve Depression ( STAR * D ) Level 1 treatment phase ( 14 weeks citalopram monotherapy ) .
-METHODS	Fatigue was assessed with item 14 on energy level from the 16-item Quick Inventory of Depressive Symptomatology-Self-Report ( QIDS-SR16 ; scored 0-3 : 0 = no fatigue , 3 = maximal fatigue ) ; prospective fatigue : assessment of fatigue at Level 1 entry and exit ( no fatigue , treatment-emergent fatigue , remitted fatigue , or residual fatigue ) .
-BACKGROUND	Http://clinicaltrials.gov , NCT00021528 .
-METHODS	Remission of depressive symptoms ( 17-item Hamilton Rating Scale for Depression 7 or QIDS-SR16 5 ) ; Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form ; Short-Form Health Survey Mental and Physical subscales ; and Work and Social Adjustment Scale ( WSAS ) .
-RESULTS	At baseline , of 2868 patients included in the analyses , 5.5 % had a QIDS-SR16 item 14 score of 0 ; 22.9 % , a score of 1 ; 53.6 % , a score of 2 ; and 18.0 % , a score of 3 .
-RESULTS	During Level 1 treatment , 3.5 % of patients had no prospective fatigue , 2.1 % had treatment-emergent fatigue , 33.6 % had fatigue remitting during treatment , and 60.8 % had residual fatigue .
-RESULTS	Female gender , unemployment , fewer years of education , and lower monthly income were significantly associated with higher rates of baseline fatigue ( all P < 0.0001 ) .
-RESULTS	Higher levels of baseline or prospective fatigue were associated with reduced likelihood of remission , decreased overall satisfaction ( P < 0.0001 ) , and reduced mental and physical function at outcome ( P0 .05 ) .
-RESULTS	Patients with higher baseline or prospective fatigue reported higher WSAS total scores ( P < 0.0001 ) , indicative of more severe functional impairment .
-CONCLUSIONS	Lower baseline fatigue and remission of fatigue during antidepressant treatment in patients with MDD are associated with higher rates of remission of depressive symptoms and better function and quality of life .
-CONCLUSIONS	Study limitations include use of the STAR * D Level 1 sample ( citalopram as only antidepressant ) , use of a proxy measure of energy/fatigue ( item 14 from the QIDS-SR16 ) , and the secondary post-hoc analysis design .
-
-###24408114
-OBJECTIVE	Increased left ventricular mass ( LVM ) , low ventricular ejection fraction ( EF ) , and high pulse-wave velocity ( PWV ) relate to overall and cardiovascular mortality in patients with ESRD .
-OBJECTIVE	The aim of this study was to determine the effect of online hemodiafiltration ( HDF ) versus low-flux hemodialysis ( HD ) on LVM , EF , and PWV .
-METHODS	Echocardiography was used to assess LVM and EF in 342 patients in the CONvective TRAnsport STudy followed for up to 4 years .
-METHODS	PWV was measured in 189 patients for up to 3 years .
-METHODS	Effect of HDF versus HD on LVM , EF , and PWV was evaluated using linear mixed models .
-RESULTS	Patients had a mean age of 63 years , and 61 % were male .
-RESULTS	At baseline , median LVM was 227 g ( interquartile range [ IQR ] , 183-279 g ) , and median EF was 65 % ( IQR , 55 % -72 % ) .
-RESULTS	Median PWV was 9.8 m/s ( IQR , 7.5-12 .0 m/s ) .
-RESULTS	There was no significant difference between the HDF and HD treatment groups in rate of change in LVM ( HDF : change , -0.9 g/yr [ 95 % confidence interval ( 95 % CI ) , -8.9 to 7.7 g ] ; HD : change , 12.5 g/yr [ 95 % CI , -3.0 to 27.5 g ] ; P for difference = 0.13 ) , EF ( HDF : change , -0.3 % / yr [ 95 % CI , -2.3 % to 1.8 % ] ; HD : change , -3.4 % / yr [ 95 % CI , -5.9 % to -0.9 % ] ; P = 0.17 ) , or PWV ( HDF : change , -0.0 m/s per year [ 95 % CI , -0.4 to 0.4 m/s ) ; HD : change , 0.0 m/s per year [ 95 % CI , -0.3 to 0.2 m/s ] ; P = 0.89 ) .
-RESULTS	No differences in rate of change between treatment groups were observed for subgroups of age , sex , residual kidney function , dialysis vintage , history of cardiovascular disease , diabetes , or convection volume .
-CONCLUSIONS	Treatment with online HDF did not affect changes in LVM , EF , or PWV over time compared with HD .
-
-###25442801
-OBJECTIVE	The progressive changes in lung morphology observed in cystic fibrosis ( CF ) can potentially affect the statistical distribution of computed tomography ( CT ) density values .
-OBJECTIVE	This study aimed to characterize the lung CT density distributions by quantifying indices of the kurtosis and skewness of the lung density distribution and to compare these indices to radiologic scores and lung function parameters in children and young adults with CF.
-METHODS	CT scans and lung function of 26 patients with CF were retrospectively examined .
-METHODS	The Bhalla radiologic scoring was performed separately , in random order , by two expert radiologists , blinded to the patient 's identity , age , clinical status , results of lung function tests , and the other paired observer 's score .
-RESULTS	Positive relations were evidenced between the log indices of lung density distribution kurtosis ( iKurtosis ) and the overall radiologic scores ( RS ) of both observers ( R = 0.58 ; P < .001 vs RS1 and R = 0.71 ; P < .001 vs RS2 ) .
-RESULTS	A similar relationship was evidenced with the log index of the degree of distribution asymmetry ( iSkewness ; R = 0.62 ; P < .001 vs RS1 and R = 0.62 ; P < .001 vs RS2 ) .
-RESULTS	Log-iKurtosis and log-iSkewness were related to FEV1 ( R = -0.56 ; P < 10 ( -5 ) and R = -0.55 ; P < 10 ( -5 ) ) and to residual volume ( R = 0.40 ; P < .001 and R = 0.45 ; P < .001 , respectively ) .
-RESULTS	Both radiologic scores showed significant relation with lung function .
-RESULTS	The correlation between RS1 and RS2 was excellent ( R = 0.93 ) , with a Cohen weighted kappa of 0.43 .
-CONCLUSIONS	Characteristic indices of lung CT density distribution are correlated to lung function and radiologic scores in patients with CF and merit further evaluation as part of more comprehensive automated methods for quantifying CF lung CT data .
-
-###25244631
-OBJECTIVE	To compare the tissue reaction produced by 2 gauges of implanted polyglactin 910 ( Vicryl ) suture material in human skin .
-METHODS	A prospective , double masked , parallel randomized IRB approved clinical trial .
-METHODS	Consecutive patients with involutional entropion and horizontal eyelid laxity were randomly allocated to 5/0 or 7/0 gauge test suture groups .
-METHODS	Symptoms were alleviated during the wait for definitive surgery by placement of eyelid everting sutures .
-METHODS	After 28 days , surgical entropion correction including eyelid wedge excision was achieved .
-METHODS	Histological analysis was carried out , masked to the suture gauge used , on the excised eyelid containing one of the temporary everting sutures .
-METHODS	Both patient and analyst were masked to the suture group .
-METHODS	The four primary outcome measurements were granuloma outer diameter , central cellular diameter , giant cell number and area of fibrous coat and a statistical comparison made between suture gauge groups .
-RESULTS	21 patients were allocated to each group , and histological analysis was possible in 36 patients .
-RESULTS	Significant suture-related granulomatous inflammatory reactions were found in all specimens .
-RESULTS	Medians of the measurements for 5/0 and 7/0 gauge sutures , respectively , were 0.855 mm versus 0.387 mm granuloma outer diameter ( p = 0.0001 ) ; 0.464 mm versus 0.250 mm central cellular element diameter ( p = 0.0003 ) ; 0.194 mm ( 2 ) versus 0.053 mm ( 2 ) fibrous coat area ( p = 0.0009 ) and 0.8 versus 1.2 giant cell number ( p = 0.7511 ) .
-CONCLUSIONS	Polyglycolic acid sutures elicit a significant foreign body inflammatory response proportional to suture gauge .
-CONCLUSIONS	This reaction may be minimized by early suture removal .
-CONCLUSIONS	The study validates a novel and ethical approach to the examination of human skin response to implanted suture material .
-
-###25857665
-OBJECTIVE	Ulcerative colitis ( UC ) is difficult to treat , and standard therapy does not always induce remission .
-OBJECTIVE	Fecal microbiota transplantation ( FMT ) is an alternative approach that induced remission in small series of patients with active UC .
-OBJECTIVE	We investigated its safety and efficacy in a placebo-controlled randomized trial .
-METHODS	We performed a parallel study of patients with active UC without infectious diarrhea .
-METHODS	Participants were examined by flexible sigmoidoscopy when the study began and then were randomly assigned to groups that received FMT ( 50 mL , via enema , from healthy anonymous donors ; n = 38 ) or placebo ( 50 mL water enema ; n = 37 ) once weekly for 6 weeks .
-METHODS	Patients , clinicians , and investigators were blinded to the groups .
-METHODS	The primary outcome was remission of UC , defined as a Mayo score 2 with an endoscopic Mayo score of 0 , at week 7 .
-METHODS	Patients provided stool samples when the study began and during each week of FMT for microbiome analysis .
-METHODS	The trial was stopped early for futility by the Data Monitoring and Safety Committee , but all patients already enrolled in the trial were allowed to complete the study .
-RESULTS	Seventy patients completed the trial ( 3 dropped out from the placebo group and 2 from the FMT group ) .
-RESULTS	Nine patients who received FMT ( 24 % ) and 2 who received placebo ( 5 % ) were in remission at 7 weeks ( a statistically significant difference in risk of 17 % ; 95 % confidence interval , 2 % -33 % ) .
-RESULTS	There was no significant difference in adverse events between groups .
-RESULTS	Seven of the 9 patients in remission after FMT received fecal material from a single donor .
-RESULTS	Three of the 4 patients with UC 1 year entered remission , compared with 6 of 34 of those with UC > 1 year ( P = .04 , Fisher 's exact test ) .
-RESULTS	Stool from patients receiving FMT had greater microbial diversity , compared with baseline , than that of patients given the placebo ( P = .02 , Mann-Whitney U test ) .
-CONCLUSIONS	FMT induces remission in a significantly greater percentage of patients with active UC than placebo , with no difference in adverse events .
-CONCLUSIONS	Fecal donor and time of UC appear to affect outcomes .
-CONCLUSIONS	ClinicalTrials.gov Number : NCT01545908 .
-
-###25344113
-BACKGROUND	Critically ill patients often require renal replacement therapy accompanied by thrombocytopenia .
-BACKGROUND	Thrombocytopenia during heparin anticoagulation may be due to heparin-induced thrombocytopenia with need for alternative anticoagulation .
-BACKGROUND	Therefore , we compared argatroban and lepirudin in critically ill surgical patients .
-METHODS	Following institutional review board approval and written informed consent , critically ill surgical patients more than or equal to 18 years with suspected heparin-induced thrombocytopenia , were randomly assigned to receive double-blind argatroban or lepirudin anticoagulation targeting an activated Partial Thromboplastin Time ( aPTT ) of 1.5 to 2 times baseline .
-METHODS	In patients requiring continuous renal replacement therapy we compared the life-time of hemodialysis filters .
-METHODS	We evaluated in all patients the incidence of bleeding and thrombembolic events .
-RESULTS	We identified 66 patients with suspected heparin-induced thrombocytopenia , including 28 requiring renal replacement therapy .
-RESULTS	Mean filter lifetimes did not differ between groups ( argatroban 3225 hours ( n = 12 ) versus lepirudin 2721 hours ( n = 16 ) , mean difference 5 hours , 95 % CI -13 to 23 , P = 0.227 ) .
-RESULTS	Among all 66 patients , relevant bleeding occurred in four argatroban - versus eleven lepirudin-patients ( OR 3.9 , 95 % CI 1.1 to 14.0 , P = 0.040 ) .
-RESULTS	In the argatroban-group , three thromboembolic events occurred compared to two in the lepirudin group ( OR 0.7 , 95 % CI 0.1 to 4.4 , P = 0.639 ) .
-RESULTS	The incidence of confirmed heparin-induced thrombocytopenia was 23 % ( n = 15 ) in our study population .
-CONCLUSIONS	This first randomized controlled double-blind trial comparing two direct thrombin inhibitors showed comparable effectiveness for renal replacement therapy , but suggests fewer bleeds in surgical patients with argatroban anticoagulation .
-BACKGROUND	Clinical Trials.gov NCT00798525 .
-BACKGROUND	Registered 25 November 2008 .
-
-###24622114
-OBJECTIVE	This study sought to assess the prognostic value of physical examination in a modern treated heart failure population .
-BACKGROUND	The physical examination is the cornerstone of the evaluation and monitoring of patients with heart failure .
-BACKGROUND	Yet , the prognostic value of congestive signs ( i.e. , peripheral edema , jugular venous distension , a third heart sound , and pulmonary rales ) has not been assessed in the current era .
-METHODS	A post-hoc analysis was conducted on all 1,376 patients , 81 % male , mean age 67 11 years , with symptomatic left ventricular systolic dysfunction enrolled in the AF-CHF ( Atrial Fibrillation and Congestive Heart Failure ) trial .
-METHODS	The prognostic value of baseline physical examination findings was assessed in univariate and multivariate Cox regression analyses .
-RESULTS	Peripheral edema was observed in 425 ( 30.9 % ) , jugular venous distension in 297 ( 21.6 % ) , a third heart sound in 207 ( 15.0 % ) , and pulmonary rales in 178 ( 12.9 % ) patients .
-RESULTS	Death from cardiovascular causes occurred in 357 ( 25.9 % ) patients over a mean follow-up of 37 19 months .
-RESULTS	All 4 physical examination findings were associated with cardiovascular mortality in univariate analyses ( all p values < 0.01 ) .
-RESULTS	In multivariate analyses , taking all 4 signs as potential covariates , only rales ( hazard ratio 1.41 ; 95 % confidence interval : 1.07 to 1.86 ; p = 0.013 ) and peripheral edema ( hazard ratio : 1.25 ; 95 % confidence interval : 1.00 to 1.57 ; p = 0.048 ) were associated with cardiovascular mortality , independent of other variables .
-CONCLUSIONS	In the modern era , congestive signs on the physical examination ( i.e. , peripheral edema , jugular venous distension , a third heart sound , and pulmonary rales ) continue to provide important prognostic information in patients with congestive heart failure .
-
-###24947926
-OBJECTIVE	Gastric cancers may harbor a subset of cells with cancer stem cell ( CSC ) properties , including chemotherapy resistance , and CD44 is a gastric CSC marker .
-OBJECTIVE	The Hedgehog ( HH ) pathway is a key developmental pathway that can be subverted by CSCs during tumorigenesis .
-OBJECTIVE	Here , we examine the role of HH signaling in CD44 ( + ) gastric cancer cells .
-METHODS	Gastric cancer cell lines , tumor xenografts , and patient tumors were examined .
-RESULTS	Gastric cancer cell lines AGS , MKN-45 , and NCI-N87 grown as spheroids or sorted for CD44 ( + ) were found to have upregulation of HH pathway proteins .
-RESULTS	HH inhibition using Smoothened ( Smo ) shRNA or vismodegib ( VIS ) decreased spheroid formation and colony formation .
-RESULTS	CD44 ( + ) cells , compared with unselected cells , were also resistant to 5-fluorouracil and cisplatin chemotherapy , and this resistance was reversed in vitro and in xenografts with Smo shRNA or VIS .
-RESULTS	CD44 ( + ) cells also had significantly more migration , invasion , and anchorage-independent growth , and these properties could all be blocked with HH inhibition .
-RESULTS	Clinical tumor samples from a phase II trial of chemotherapy with or without VIS for advanced gastric cancer were analyzed for CD44 expression .
-RESULTS	In the chemotherapy alone group , high CD44 expression was associated with decreased survival , whereas in the chemotherapy plus VIS group , high CD44 expression was associated with improved survival .
-CONCLUSIONS	HH signaling maintains CSC phenotypes and malignant transformation phenotypes in CD44 ( + ) gastric cancer cells , and HH inhibition can reverse chemotherapy resistance in CD44 ( + ) cells .
-CONCLUSIONS	Gastric cancer is a heterogeneous disease , and the strategy of combining chemotherapy with HH inhibition may only be effective in tumors with high CD44 levels .
-
-###25521872
-OBJECTIVE	We compared 2 strategies for disseminating an evidence-based skin cancer prevention program .
-METHODS	We evaluated the effects of 2 strategies ( basic vs enhanced ) for dissemination of the Pool Cool skin cancer prevention program in outdoor swimming pools on ( 1 ) program implementation , maintenance , and sustainability and ( 2 ) improvements in organizational and environmental supports for sun protection .
-METHODS	The trial used a cluster-randomized design with pools as the unit of intervention and outcome .
-METHODS	The enhanced group received extra incentives , reinforcement , feedback , and skill-building guidance .
-METHODS	Surveys were collected in successive years ( 2003-2006 ) from managers of 435 pools in 33 metropolitan areas across the United States participating in the Pool Cool Diffusion Trial .
-RESULTS	Both treatment groups improved their implementation of the program , but pools in the enhanced condition had significantly greater overall maintenance of the program over 3 summers of participation .
-RESULTS	Furthermore , pools in the enhanced condition established and maintained significantly greater sun-safety policies and supportive environments over time .
-CONCLUSIONS	This study found that more intensive , theory-driven dissemination strategies can significantly enhance program implementation and maintenance of health-promoting environmental and policy changes .
-CONCLUSIONS	Future research is warranted through longitudinal follow-up to examine sustainability .
-
-###24727254
-OBJECTIVE	This study sought to test 2 hypotheses : 1 ) fibroblast growth factor ( FGF ) -23 identifies patients with stable ischemic heart disease ( SIHD ) at high risk of cardiovascular events independent of clinical factors , renal function , and established cardiovascular biomarkers ; and 2 ) FGF-23 identifies patients who derive greater clinical benefit from angiotensin-converting enzyme inhibitor therapy .
-BACKGROUND	FGF-23 is an endocrine regulator of mineral metabolism and markedly elevated levels are associated with cardiovascular events in patients with chronic kidney disease .
-BACKGROUND	Data in patients with SIHD are more sparse .
-METHODS	FGF-23 levels were measured in 3,627 patients with SIHD randomly assigned to trandolapril or placebo within the PEACE ( Prevention of Events With Angiotensin-Converting Enzyme ) trial and followed up for a median of 5.1 years .
-RESULTS	After adjustment for clinical risk predictors , left ventricular ejection fraction , markers of renal function , and established cardiovascular biomarkers , FGF-23 concentration was independently associated with an increased risk of cardiovascular death or heart failure among patients allocated to placebo ( quartile 4 hazard ratio : 1.73 ; 95 % confidence interval , 1.09 to 2.74 ; p = 0.02 ) and significantly improved metrics of discrimination .
-RESULTS	Furthermore , among patients in the top quartile of FGF-23 levels , trandolapril significantly reduced cardiovascular death or incident heart failure ( hazard ratio : 0.45 ; 95 % confidence interval : 0.28 to 0.72 ) , whereas there was no clinical benefit in the remaining patients ( hazard ratio : 1.07 ; 95 % confidence interval : 0.75 to 1.52 ; p interaction = 0.0039 ) .
-RESULTS	This interaction was independent of and additive to stratification based on renal function .
-CONCLUSIONS	Elevated levels of FGF-23 are associated with cardiovascular death and incident heart failure in patients with SIHD and identify patients who derive significant clinical benefit from angiotensin-converting enzyme inhibitor therapy regardless of renal function .
-CONCLUSIONS	( Prevention of Events With Angiotensin-Converting Enzyme Inhibitor Therapy [ PEACE ] : NCT00000558 ) .
-
-###25880034
-BACKGROUND	One of the most common symptoms observed in patients with dementia is agitation , and several non-pharmacological treatments have been used to control this symptom .
-BACKGROUND	However , because of limitations in research design , the benefit of non-pharmacological treatments has only been demonstrated in certain cases .
-BACKGROUND	The purpose of this study was to compare aroma-acupressure and aromatherapy with respect to their effects on agitation in patients with dementia .
-METHODS	In this experimental study , the participants were randomly assigned to three groups : 56 patients were included in the aroma-acupressure group , 73 patients in the aromatherapy group , and 57 patients in the control group who received daily routine as usual without intervention .
-METHODS	The Cohen-Mansfield Agitation Inventory ( CMAI ) scale and the heart rate variability ( HRV ) index were used to assess differences in agitation .
-METHODS	The CMAI was used in the pre-test , post-test and post-three-week test , and the HRV was used in the pre-test , the post-test and the post-three-week test as well as every week during the four-week interventions .
-RESULTS	The CMAI scores were significantly lower in the aroma-acupressure and aromatherapy groups compared with the control group in the post-test and post-three-week assessments .
-RESULTS	Sympathetic nervous activity was significantly lower in the fourth week in the aroma-acupressure group and in the second week in the aromatherapy group , whereas parasympathetic nervous activity increased from the second week to the fourth week in the aroma-acupressure group and in the fourth week in the aromatherapy group .
-CONCLUSIONS	Aroma-acupressure had a greater effect than aromatherapy on agitation in patients with dementia .
-CONCLUSIONS	However , agitation was improved in both of the groups , which allowed the patients with dementia to become more relaxed .
-CONCLUSIONS	Future studies should continue to assess the benefits of aroma-acupressure and aromatherapy for the treatment of agitation in dementia patients .
-BACKGROUND	ChiCTR-TRC-14004810 ; Date of registration : 2014/6/12 .
-
-###24840317
-OBJECTIVE	Prandial treatment with human regular insulin for diabetes may result in early postprandial hyperglycaemia and late hypoglycaemia due to its slow onset and long duration of action .
-OBJECTIVE	This study compared injections of recombinant human insulin ( rHI ) formulated with recombinant human hyaluronidase [ rHuPH20 ] ( INSULIN-PH20 ) to insulin lispro for prandial treatment in subjects with type 1 diabetes ( T1D ) .
-METHODS	After a 1-month run-in period using twice-daily insulin glargine ( or usual basal insulin therapy for pump users ) with prandial lispro , 46 subjects with T1D ( 42 13 years ; body mass index : 26 4 kg/m ( 2 ) ; A1c : 6.8 0.5 % ) were assigned to INSULIN-PH20 or lispro in a random sequence for two consecutive , 12-week periods as the prandial insulin in an intensive treatment regimen .
-RESULTS	The mean glycaemic excursion for INSULIN-PH20 ( 0.96 2.00 mmol/l ) was comparable ( p = 0.322 ) to lispro ( 0.80 1.95 mmol/l ) .
-RESULTS	The 8-point self-monitored blood glucose profiles were also comparable in the two groups .
-RESULTS	Good glycaemic control ( A1c ) was maintained for both treatments at 12 weeks ( INSULIN-PH20 : 7.0 0.5 % ; lispro : 6.9 0.6 % ) .
-RESULTS	Overall rates of hypoglycaemia ( 3.9 mmol/l ) were 24 events per patient per 4 weeks for INSULIN-PH20 and 22 events for lispro .
-RESULTS	There were no significant differences in adverse events or immunogenicity between treatments and both treatments were well tolerated .
-CONCLUSIONS	Unlike commercially available formulations of regular human insulin , a formulation of rHI with rHuPH20 was comparable to lispro for postprandial glucose excursions in a basal-bolus treatment regimen for T1D patients .
-CONCLUSIONS	Glycaemic control , safety and tolerability profiles were comparable for both treatments .
-
-###25547580
-OBJECTIVE	To observe practicality and safety of CT-RIDC for the patients with presaccular lacrimal obstruction and study the related factors .
-OBJECTIVE	To provide guidance for the diagnosis and treatment of the patients with presaccular lacrimal obstruction .
-METHODS	Fifty-four patients ( 75 eyes ) with presaccular lacrimal obstruction , including 3 cases ( 5 eyes ) of upper and lower lacrimal punctum atresia , 15 cases ( 24 eyes ) of superior and inferior canalicular obstruction , 18 cases ( 28 eyes ) of common canaliculus obstruction , 18 cases ( 18 eyes ) of old laceration of superior and inferior canalicular , were recruited .
-METHODS	All patients underwent the examination by using 0 and 30 ear endoscope and the imaging characteristics of the inferior orifice of nasolacrimal duct were obtained .
-METHODS	Fifty-three cases ( 65 eyes ) with the opening inferior orifice were randomly divided into four groups ( 15 eyes , 17 eyes , 17 eyes , 16 eyes ) according to different angle of head hypsokinesis in the supine position .
-METHODS	The OM lines back along the sagittal plane of the head back 10 , 20 , 30 , 40 were measured .
-METHODS	The angles of head hypsokinesis were set in accordance with the OM line measurement results.Intubation was successful when the intubation guided needle within the set of epidural anesthetic catheter aided with endoscopy was inserted into the inferior orifice of nasolacrimal duct and then the epidural anesthetic catheter was inserted into the lacrimal duct 6 mm .
-METHODS	The angle ( ) between the long axis of the curved part of the intubation guided needle and the long axis of the guided needle was measured .
-METHODS	The numbers of intubation success cases in each group were recorded .
-METHODS	test was used to compare intubation success rate under the different angle of head hypsokinesis.Scheffe method was used to compare intubation success rate between each group .
-METHODS	Contrast medium was then injected into lacrimal duct through the epidural anesthetic catheter for patients with successful intubation and CT scan was carried out .
-METHODS	3D model of lacrimal passage was reconstructed with CT axial scanning .
-RESULTS	The intubation guided needle was successfully inserted into the inferior orifice of nasolacrimal duct in 44 eyes among 65 eyes with the opening orifice .
-RESULTS	The number of successful intubation cases were 4 eyes , 15 eyes , 13 eyes , 12 eyes and the intubation success rate was 26.67 % , 88.24 % , 76.74 % , 75.00 % according the angle of head hypsokinesis 10 group ( 15 eyes ) , 20 group ( 17 eyes ) , 30 group ( 17 eyes ) , 40 group ( 16 eyes ) .
-RESULTS	The intubation success rate of head hypsokinesis 10 group was significantly lower than that of the other groups .
-RESULTS	Multiple Comparison by Scheffe Test demonstrated that there was a remarkable difference ( P < 0.05 ) in the intubation success rate between head hypsokinesis 10 group and the other three groups .
-RESULTS	There were no significant differences in the intubation success rate among head hypsokinesis 20 group , head hypsokinesis 30 group and head hypsokinesis 40 group .
-RESULTS	The mean of was 108 with a range of 93.2-120 .5 by measuring the angle of the successful intubation cases .
-RESULTS	According to the frequency distribution plot , most was in 104-115 .
-RESULTS	The successful intubation cases ( 44 eyes ) underwent CT scan in the same position immediately after injected contrast medium ( Optiray ) through the epidural anesthetic catheter .
-RESULTS	CT images of 28 eyes showed retained contrast medium in the nasolacrimal duct and lacrimal sac .
-RESULTS	The findings from CT-DCG images were basically agreed with the operation .
-CONCLUSIONS	CD-RIDC may apply to pre-operative examination for the patients with the opening orifice and presaccular lacrimal obstruction.It provideed imaging evidence for diagnosis and therapy and it was safe and practical .
-CONCLUSIONS	Many factors could affect CD-RIDC .
-CONCLUSIONS	The main verified facors were the shape of the inferior orifice of nasolacrimal duct , head position of the patient and the bending angle of the tip of intubation guided needle .
-
-###25344393
-BACKGROUND	Existing psychological therapies for bipolar disorders have been found to have mixed results , with a consensus that they provide a significant , but modest , effect on clinical outcomes .
-BACKGROUND	Typically , these approaches have focused on promoting strategies to prevent future relapse .
-BACKGROUND	An alternative treatment approach , termed ` Think Effectively About Mood Swings ' ( TEAMS ) addresses current symptoms , including subclinical hypomania , depression and anxiety , and promotes long-term recovery .
-BACKGROUND	Following the publication of a theoretical model , a range of research studies testing the model and a case series have demonstrated positive results .
-BACKGROUND	The current study reports the protocol of a feasibility randomized controlled trial to inform a future multi-centre trial .
-METHODS	A target number of 84 patients with a diagnosis of bipolar I or II disorder , or bipolar disorder not-otherwise-specified are screened , allocated to a baseline assessment and randomized to either 16 sessions of TEAMS therapy plus treatment-as-usual ( TAU ) or TAU .
-METHODS	Patients complete self-report inventories of depression , anxiety , recovery status and bipolar cognitions targeted by TEAMS .
-METHODS	Assessments of diagnosis , bipolar symptoms , medication , access to services and quality of life are conducted by assessors blind to treatment condition at 3 , 6 , 12 and 18 months post-randomization .
-METHODS	The main aim is to evaluate recruitment and retention of participants into both arms of the study , as well as adherence to therapy , to determine feasibility and acceptability .
-METHODS	It is predicted that TEAMS plus TAU will reduce self-reported depression in comparison to TAU alone at six months post-randomization .
-METHODS	The secondary hypotheses are that TEAMS will reduce the severity of hypomanic symptoms and anxiety , reduce bipolar cognitions , improve social functioning and promote recovery compared to TAU alone at post-treatment and follow-up .
-METHODS	The study also incorporates semi-structured interviews about the experiences of previous treatment and the experience of TEAMS therapy that will be subject to qualitative analyses to inform future developments of the approach .
-CONCLUSIONS	The design will provide preliminary evidence of efficacy , feasibility , acceptability , uptake , attrition and barriers to treatment to design a definitive trial of this novel intervention compared to treatment as usual .
-BACKGROUND	This trial was registered with Current Controlled Trials ( ISRCTN83928726 ) on registered 25 July 2014 .
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-###25865762
-BACKGROUND	Annular stabilization is important during bicuspid aortic valve ( BAV ) repair to obtain the best long-term results .
-BACKGROUND	This report describes the early outcomes of a novel bicuspid annuloplasty ring for this purpose .
-METHODS	Under regulatory supervision ( NCT02071849 ) , a geometric bicuspid annuloplasty ring was used during valve repair in 16 patients .
-METHODS	Three patients had Sievers type 0 valves , 11 had Sievers type 1 , and 2 had Sievers type 2 .
-METHODS	Thirteen patients had left - / right-coronary cusp fusion , 1 had right - / noncoronary cusp fusion , and 2 had both .
-METHODS	Moderate to severe aortic insufficiency ( AI ) was present in 13 of 16 patients , and 3 had mild AI with aortic aneurysms .
-METHODS	Ascending aortic aneurysms , root aneurysms , or both were replaced in 7 of 16 patients .
-METHODS	The Dacron-covered titanium ring had circular base geometry and two outwardly flaring subcommissuralposts positioned opposite on the circumference .
-METHODS	The ring was implanted into the annulus beneath the valve , and then leaflet repair was performed .
-RESULTS	Immediate postrepair echocardiograms showed grade 0 residual AI in all patients , with good cusp mobility and effective height , and satisfactory gradients .
-RESULTS	There were no in-hospital or late mortalities .
-RESULTS	Two patients experienced leaflet tears from long annular suture tails , requiring late valve replacement .
-RESULTS	After implementation of a lateral suture fixation technique , no more failures occurred .
-RESULTS	At a mean follow-up time of 9 months , the remaining 14 patients were in New York Heart Association class I , with predominant grade 0 AI .
-CONCLUSIONS	As a technique for BAV repair , internal ring annuloplasty produces major annular remodeling and stabilization .
-CONCLUSIONS	Annular reduction and reshaping to a 50/50 % symmetric circular geometry facilitates leaflet repair and enhances cusp coaptation .
-CONCLUSIONS	Geometric ring annuloplasty could have useful applications in BAV repair .
-
-###24587475
-OBJECTIVE	To develop a CSF metabolomics signature for motor neuron disease ( MND ) using ( 1 ) H-NMR spectroscopy and to evaluate the predictive value of the profile in a separate cohort .
-METHODS	We collected CSF from patients with MND and controls and analyzed the samples using ( 1 ) H-NMR spectroscopy .
-METHODS	We divided the total patient sample in a 4:1 ratio into a training cohort and a test cohort .
-METHODS	First , a metabolomics signature was created by statistical modeling in the training cohort , and then the analyses tested the predictive value of the signature in the test cohort .
-METHODS	We conducted 10 independent trials for each step .
-METHODS	Finally , we identified the compounds that contributed most consistently to the metabolome profile .
-RESULTS	Analysis of CSF from 95 patients and 86 controls identified a diagnostic profile for MND ( R ( 2 ) X > 22 % , R ( 2 ) Y > 93 % , Q ( 2 ) > 66 % ) .
-RESULTS	The best model selected the correct diagnosis with mean probability of 99.31 % in the training cohort .
-RESULTS	The profile discriminated between diagnostic groups with 78.9 % sensitivity and 76.5 % specificity in the test cohort .
-RESULTS	Metabolites linked to pathophysiologic pathways in MND ( i.e. , threonine , histidine , and molecules related to the metabolism of branched amino acids ) were among the discriminant compounds .
-CONCLUSIONS	CSF metabolomics using ( 1 ) H-NMR spectroscopy can detect a reproducible metabolic signature for MND with reasonable performance .
-CONCLUSIONS	To our knowledge , this is the first metabolomics study that shows that a validation in separate cohorts is feasible .
-CONCLUSIONS	These data should be considered in future biomarker studies .
-METHODS	This study provides Class III evidence that CSF metabolomics accurately distinguishes MNDs from other neurologic diseases .
-
-###25234526
-OBJECTIVE	The purpose of this study was to determine the efficacy of pre-emptive analgesia with pregabalin and celecoxib on narcotic consumption and perceived pain in adult patients undergoing maxillomandibular advancement surgery for obstructive sleep apnea .
-METHODS	This was a prospective , randomized , double-blinded , placebo-controlled study of adult patients undergoing elective maxillomandibular advancement surgery for obstructive sleep apnea .
-METHODS	The groups received a masked 1-time preoperative oral dose of pregabalin 150 mg and celecoxib 400 mg ( experimental group ) or lactose powder 2 g ( placebo group ) .
-METHODS	In the postoperative period , pain management consisted of intravenous morphine patient-controlled analgesia and oral oxycodone 5 mg and acetaminophen 325 mg .
-METHODS	Patients completed a daily pain and narcotic log .
-METHODS	Statistical significance between group means was determined by the 2-tailed independent t test .
-RESULTS	There were statistically significant differences between the pregabalin plus celecoxib and placebo groups in average intravenous morphine consumption per 4-hour interval ( 6.0 5.9 vs 9.3 7.9 mg ; P < .05 ) , mean daily narcotic pill consumption ( 2.9 2.9 vs 6.8 1.8 pills ; P < .05 ) , and mean daily visual analog scale scores ( 4.3 3.5 vs 5.5 5.0 ; P < .05 ) .
-CONCLUSIONS	Within the limitations of this study , a 1-time preoperative oral dose of pregabalin and celecoxib before adult maxillomandibular advancement surgery for obstructive sleep apnea decreased mean intravenous morphine consumption , mean daily narcotic pill consumption , and mean patient perceived pain .
-
-###25226757
-OBJECTIVE	Few well-designed randomized controlled trials ( RCT ) regarding the impact of community pharmacist interventions on pharmacotherapeutic monitoring of patients with Chronic Obstructive Pulmonary Disease [ COPD ) have been conducted .
-OBJECTIVE	We assessed the effectiveness of a pharmaceutical care program for patients with COPD .
-METHODS	The PHARMACOP-trial was a single-blind 3-month RCT , conducted in 170 community pharmacies in Belgium , enrolling patients prescribed daily COPD medication , aged > or = 50 years , and with a smoking history > or = 10 pack-years .
-METHODS	A computer-generated randomization sequence allocated patients to intervention ( n = 371 ) , receiving protocol-defined pharmacist care , or control group ( n = 363 ) , receiving usual pharmacist care 11:1 ratio , stratified by center ) .
-METHODS	Interventions , focusing on inhalation technique and adherence to maintenance therapy , were carried out at start of the trial and at one month follow-up .
-METHODS	Primary outcomes were inhalation technique and medication adherence .
-METHODS	Secondary outcomes were exacerbation rate , dyspnea , COPD specific and generic health status and smoking behavior .
-RESULTS	From December 2010 to April 2011 , 734 patients were enrolled .
-RESULTS	42 patients ( 5.7 % ) were lost to follow-up .
-RESULTS	At the end of the trial , inhalation score ( Mean estimated difference [ delta ] , 13.5 % ; 95 % Confidence Interval [ CI ] , 10.8-16 .1 ; P < .0001 ] and medication adherence [ ( delta , 8.51 % ; 95 % CI , 4.63-12 .4 ; P < .0001 ) were significantly higher in the intervention group compared to the control group .
-RESULTS	In the intervention group , a significantly lower hospitalization rate was observed ( 9 vs 35 hospitalizations ; Rate Ratio , 0.28 ; 95 % CI , 0.12-0 .64 ; P = .003 ) .
-RESULTS	No other significant between-group differences were observed .
-CONCLUSIONS	The PHARMACOP-trial demonstrates that pragmatic pharmacist care programs improve both inhalation technique and medication adherence in patients with COPD and could reduce hospitalization rates .
-CONCLUSIONS	The protocolled intervention used in this trial was specifically designed for and evaluated in ( Belgian ) community pharmacies .
-CONCLUSIONS	This may facilitate future implementation in the Belgian context .
-
-###25157723
-OBJECTIVE	Self-monitoring of blood pressure with self-titration of antihypertensives ( self-management ) results in lower blood pressure in patients with hypertension , but there are no data about patients in high-risk groups .
-OBJECTIVE	To determine the effect of self-monitoring with self-titration of antihypertensive medication compared with usual care on systolic blood pressure among patients with cardiovascular disease , diabetes , or chronic kidney disease .
-METHODS	A primary care , unblinded , randomized clinical trial involving 552 patients who were aged at least 35 years with a history of stroke , coronary heart disease , diabetes , or chronic kidney disease and with baseline blood pressure of at least 130/80 mm Hg being treated at 59 UK primary care practices was conducted between March 2011 and January 2013 .
-METHODS	Self-monitoring of blood pressure combined with an individualized self-titration algorithm .
-METHODS	During the study period , the office visit blood pressure measurement target was 130/80 mm Hg and the home measurement target was 120/75 mm Hg .
-METHODS	Control patients received usual care consisting of seeing their health care clinician for routine blood pressure measurement and adjustment of medication if necessary .
-METHODS	The primary outcome was the difference in systolic blood pressure between intervention and control groups at the 12-month office visit .
-RESULTS	Primary outcome data were available from 450 patients ( 81 % ) .
-RESULTS	The mean baseline blood pressure was 143.1 / 80.5 mm Hg in the intervention group and 143.6 / 79.5 mm Hg in the control group .
-RESULTS	After 12 months , the mean blood pressure had decreased to 128.2 / 73.8 mm Hg in the intervention group and to 137.8 / 76.3 mm Hg in the control group , a difference of 9.2 mm Hg ( 95 % CI , 5.7-12 .7 ) in systolic and 3.4 mm Hg ( 95 % CI , 1.8-5 .0 ) in diastolic blood pressure following correction for baseline blood pressure .
-RESULTS	Multiple imputation for missing values gave similar results : the mean baseline was 143.5 / 80.2 mm Hg in the intervention group vs 144.2 / 79.9 mm Hg in the control group , and at 12 months , the mean was 128.6 / 73.6 mm Hg in the intervention group vs 138.2 / 76.4 mm Hg in the control group , with a difference of 8.8 mm Hg ( 95 % CI , 4.9-12 .7 ) for systolic and 3.1 mm Hg ( 95 % CI , 0.7-5 .5 ) for diastolic blood pressure between groups .
-RESULTS	These results were comparable in all subgroups , without excessive adverse events .
-CONCLUSIONS	Among patients with hypertension at high risk of cardiovascular disease , self-monitoring with self-titration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months .
-BACKGROUND	isrctn.org Identifier : ISRCTN87171227 .
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-###25639289
-BACKGROUND	The incidence of vulvodynia in American women has been reported to be between 8.3 % and 16 % .
-BACKGROUND	However , there is no consistently effective standardized treatment for vulvodynia .
-OBJECTIVE	To determine the feasibility and potential effects of using a standardized acupuncture protocol for the treatment of women with vulvodynia .
-METHODS	The primary outcome was vulvar pain , and sexual function was the secondary outcome .
-METHODS	Pain was assessed by the Short-Form McGill Pain Questionnaire , and function was measured by the Female Sexual Function Index ( FSFI ) .
-METHODS	Thirty-six women with vulvodynia met inclusion criteria .
-METHODS	The women were randomly assigned either to the acupuncture group or to the wait-list control group .
-METHODS	The 18 subjects assigned to the acupuncture group received acupuncture two times per week for 5 weeks for a total of 10 sessions .
-RESULTS	Reports of vulvar pain and dyspareunia were significantly reduced , whereas changes in the aggregate FSFI scores suggest significant improvement in sexual functioning in those receiving acupuncture vs. those who did not .
-RESULTS	Acupuncture did not significantly increase sexual desire , sexual arousal , lubrication , ability to orgasm or sexual satisfaction in women with vulvodynia .
-CONCLUSIONS	This was the first randomized controlled pilot study to examine the use of acupuncture for the treatment of vulvodynia .
-CONCLUSIONS	The acupuncture protocol was feasible and in this small sample appeared to reduce vulvar pain and dyspareunia with an increase in overall sexual function for women with vulvodynia .
-CONCLUSIONS	This study should be replicated in a larger double-blinded randomized controlled trial .
-
-###25173538
-BACKGROUND	Patients with type 2 diabetes ( T2D ) are prone to develop preclinical myocardial dysfunction , but no single strategy to prevent progression to heart failure has been established .
-BACKGROUND	We aimed to assess whether intensified global cardiovascular ( CV ) risk factor control would improve left ventricular ( LV ) systolic and diastolic function as compared with standard of care .
-METHODS	A total of 100 patients with 1 CV risk factor ( 29 % female , mean SD age 58 10 years , LV ejection fraction 63 8 % , 16 % with LV diastolic dysfunction ) were randomized to 2 years of intensified CV risk multi-intervention ( INT , n = 50 ) or standard care ( STAND , n = 50 ) .
-METHODS	Echocardiography , including tissue Doppler imaging , and maximum exercise test were performed at baseline and study end .
-METHODS	Multi-intervention comprised lifestyle intervention and pharmacologic treatment to reach strict prespecified CV risk factor goals , whereas STAND group received current guideline care .
-RESULTS	Greater reductions were observed for hemoglobin A1c and total cholesterol in the INT group ( P < .001 and P = .021 , respectively ) , whereas blood pressure reduction was similar .
-RESULTS	Work capacity increased in INT and decreased in STAND ( P = .014 ) .
-RESULTS	There was no significant between-group difference in the change in any of the echocardiographic parameters .
-CONCLUSIONS	Two years of intensified multi-intervention in patients with T2D improved work capacity and glycemic and lipid control and had no significant benefit or harm on resting cardiac function .
-
-###25047038
-BACKGROUND	Transient receptor potential vanilloid type 1 ( TRPV1 ) is a non-selective cation channel widely expressed in skin tissues , and peripheral sensory nerve fibres .
-BACKGROUND	Activation of TRPV1 releases neuropeptides ; the resulting neurogenic inflammation is believed to contribute to the development of pruritus .
-BACKGROUND	A TRPV1 antagonist has the potential to perform as an anti-pruritic agent .
-BACKGROUND	SB705498 is a TRPV1 antagonist that has demonstrated in vitro activity against cloned TRPV1 human receptors and when orally administered has demonstrated pharmacodynamic activity in animal models and clinical studies .
-OBJECTIVE	To select a topical dose of SB705498 using the TRPV1 agonist capsaicin ; to confirm engagement of the TRPV1 antagonistic action of SB705498 and assess whether the dose selected has an effect on itch induced by two challenge agents .
-METHODS	A clinical study was conducted in 16 healthy volunteers to assess the effects of 3 doses of SB705498 on skin flare induced by capsaicin .
-METHODS	Subjects with a robust capsaicin response were chosen to determine if the selected topical formulation of SB705498 had an effect on challenge agent induced itch .
-RESULTS	Following capsaicin challenge the greatest average reduction in area of flare was seen for the 3 % formulation .
-RESULTS	This dose was selected for further investigation .
-RESULTS	Itch intensity induced by two challenge agents ( cowhage and histamine ) was assessed on the Computerised Visual Analogue Scale .
-RESULTS	The difference in average itch intensity ( Weighted Mean Over 15 Mins ) between the 3 % dose of SB705498 and placebo for the cowhage challenge was -0.64 , whilst the histamine challenge showed on average a -4.65 point change .
-CONCLUSIONS	The 3 % topical formulation of SB705498 cream was clinically well tolerated and had target specific pharmacodynamic activity .
-CONCLUSIONS	However there were no clinically significant differences on pruritus induced by either challenge agent in comparison to placebo .
-CONCLUSIONS	SB705498 is unlikely to be of symptomatic benefit for histaminergic or non-histaminergic induced itch .
-BACKGROUND	ClinicalTrials.gov NCT01673529 .
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-###24279445
-BACKGROUND	The type 2 Diabetes Mellitus treatment is currently effective but still not ideal .
-BACKGROUND	A therapy based on the incretins , which represents a significant qualitative progress , is close to an ideal .
-BACKGROUND	The first completed mortality study with dipeptidyl peptidase ( DPP4 ) inhibitors is the study called SAVOR as presented in Amsterdam during the European Cardiology Congress in 2013 .
-METHODS	SAVOR ( Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus ) randomised 16,492 patients with Type 2 Diabetes Mellitus and a high-risk of cardiovascular events treated with current per oral antidiabetics and patients treated with saxagliptin or placebo .
-METHODS	Eight thousand eight hundred and twenty patients were randomised to be treated with saxagliptin and 8,212 were randomised to be treated with placebo .
-METHODS	The average monitored period was 2.1 years .
-RESULTS	The primary goal ( cardiovascular death , nonfatal myocardial infarction and nonfatal CMP ) occurred in 7.3 % ( 613 ) patients treated with saxagliptin and in 7.2 % ( 609 ) patients treated with placebo ( HR 1.00 , p < 0.001 for non inferiority ) .
-RESULTS	The main secondary goal ( cardiovascular death , myocardial infarction , vascular stroke , hospitalisation for a heart failure or angina pectoris and myocardial revascularisation ) occurred in 12.8 % ( 1,059 ) patients treated with saxagliptin and in 12.4 % ( 1,034 ) patients treated with placebo .
-RESULTS	The number of hospitalisations for heart failure was 289 ( 3.5 % ) in the group treated with saxagliptin and 228 ( 2.8 % ) in the group treated with placebo ( p = 0.007 ) .
-CONCLUSIONS	DPP4 inhibitor saxagliptin did not increase the occurrence of ischemic cardiovascular events but it inclined to an increased hospitalisation for heart failure in patients with the already present heart failure .
-CONCLUSIONS	It did not increase the occurrence of pancreatitis .
-CONCLUSIONS	Simultaneously it significantly improved the Diabetes Mellitus control , which could signal a future improvement in cardiovascular goals .
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-###24633388
-BACKGROUND	Patients with antiplatelet and antithrombotic therapy ( AP/AT ) represent a substantial proportion of ear , nose and throat ( ENT ) patients .
-BACKGROUND	Despite the ubiquitous consideration of bleeding and ischemic/thrombembolic risk , no detailed assessment of the perioperative setting in an ENT cohort is available in the literature .
-OBJECTIVE	The goal of the present work is to give a detailed assessment of patients with AP/AT in an ENT cohort resulting in ENT-specific recommendations for daily routine .
-METHODS	In all , 400 randomized patients were asked regarding analgetic therapy in acute pain .
-METHODS	Medical data of 5211patients who underwent head and neck surgery were analyzed for AP/AT therapy .
-METHODS	Therapeutic strategies , the perioperative AP/AT therapy , duration of intensive care treatment and hospitalization ( ICT/H ) , application of erythrocytes and internistic/neurolocigal complication data were analyzed in patients with/without AP/AT .
-RESULTS	Nearly 75 % of our patients were taking AP/AT due to coronary heart disease ( CHD ) , peripheral arterial disease ( PAD ) , cardiac arrhythmia , or cardiovascular disease ( CVD ) .
-RESULTS	Patients ' questionnaire revealed that 31 % of our patients use acetylsalicylic acid in acute pain , which represents 10 % of the overall AP/AT cohort .
-RESULTS	Head and neck surgery in patients with AP/AT showed an elevated bleeding frequency ( p = 0.006 ) without an elevated risk for internistic/neurological complications .
-RESULTS	ICT/H were remarkably prolonged ( p = 0.006 ; p = 0.0004 ) .
-CONCLUSIONS	Head and neck surgery in patients with AP/AT can be routinely performed .
-CONCLUSIONS	Indication for intensive care , endotracheal intubation , and tracheostomy should be made generously due to high requirements of airway management in ENT .
-CONCLUSIONS	Ischemic/thrombembolic and bleeding risk requires careful assessment in an interdisciplinary setting .
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-###25230154
-BACKGROUND	The mechanism of reflux protection may involve a ` flap valve ' at the oesophago-gastric junction ( OGJ ) .
-OBJECTIVE	To assess the effects of baclofen , a gamma-aminobutyric acid receptor type-B ( GABA-B ) agonist known to suppress reflux events , on the ` functional anatomy ' of the OGJ and proximal stomach after a large test meal .
-METHODS	Twelve healthy volunteers ( HVs ) and 12 patients with gastro-oesophageal reflux disease ( GERD ) ; with erosive oesophagitis or pathological oesophageal acid exposure completed a randomised , double-blind , cross-over study .
-METHODS	On 2 test days participants received 40-mg baclofen or placebo before ingestion of a large test meal .
-METHODS	OGJ structure and function were assessed by high-resolution manometry ( HRM ) and magnetic resonance imaging ( MRI ) using validated methods .
-METHODS	Measurements of the oesophago-gastric angle were derived from three-dimensional models reconstructed from anatomic MRI images .
-METHODS	Cine-MRI and HRM identified postprandial reflux events .
-METHODS	Mixed model analysis and Wilcoxon rank signed tests assessed differences between participant groups and treatment conditions .
-RESULTS	In both HVs and GERD patients , baclofen reduced the frequency of postprandial reflux events .
-RESULTS	The oesophago-gastric insertion angle in GERD patients was reduced ( -4.1 1.8 , P = 0.025 ) , but was unchanged in healthy controls .
-RESULTS	In both study groups , baclofen augmented lower oesophageal sphincter ( LES ) pressure ( HVs : +7.3 1.8 mmHg , P < 0.0001 , GERD : +4.50 1.49 mmHg , P < 0.003 ) and increased LES length ( HVs : +0.48 0.11 cm , P < 0.0003 , GERD : +0.35 0.06 cm , P < 0.0001 ) .
-CONCLUSIONS	Baclofen inhibits transient LES relaxations and augments LES pressure and length .
-CONCLUSIONS	Additionally , baclofen has effects on the ` functional anatomy ' of the OGJ and proximal stomach in GERD patients , which may suppress reflux by means of a ` flap valve ' mechanism .
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-###25007695
-BACKGROUND	The aim of the current study is to compare the accuracy of the ultrasound ( US ) versus clinical assessment for determination of the spinal level , using X-ray as the Gold Standard for control .
-METHODS	200 patients were randomized into two equal groups .
-METHODS	Patients in the Clinical Group were examined by landmarks to assess the Assumed Clinical Tuffier 's Line , and then by fluoroscopy to determine the True Clinical Tuffier 's Line .
-METHODS	Patients in the Ultrasound Group were examined by the ultrasound to determine the Ultrasound Tuffier 's Line .
-METHODS	The results of both groups were compared in relation to the plain X-ray , done for each patient , which determined the Radiological Tuffier 's Line .
-RESULTS	In the Clinical Group , the True Clinical Tuffier 's line met the Assumed Tuffier 's line in only 12 % of the patients .
-RESULTS	In the remaining patients , wrong leveling ranged from one space above in 80 % to 2 spaces above in 7 % and in 1 % of patients the line was at L2 .
-RESULTS	In the Ultrasound Group , wrong leveling occurred in 22 % of patients .
-RESULTS	The Ultrasound misidentification was less than one level in 17 % and one level in 5 % of patients .
-RESULTS	Ultrasound examination had a true limitation of 2 % of patients .
-CONCLUSIONS	Ultrasound examination of the spine is recommended in patients planned for spinal anesthesia , as it is superior to clinical assessment in identification of the interspinous levels .
-CONCLUSIONS	This will decrease the hazard of spinal cord trauma .
-
-###25719725
-BACKGROUND	The purpose of this study was to evaluate the clinical outcomes of cografting of acellular dermal matrix with autologous split-thickness skin and autologous split-thickness skin graft alone for full-thickness skin defects on the extremities .
-METHODS	In this prospective randomized study , 19 consecutive patients with full-thickness skin defects on the extremities following trauma underwent grafting using either cograft of acellular dermal matrix with autologous split-thickness skin graft ( nine patients , group A ) or autologous split-thickness skin graft alone ( 10 patients , group B ) from June of 2011 to December of 2012 .
-METHODS	The postoperative evaluations included observation of complications ( including graft necrosis , graft detachment , or seroma formation ) and Vancouver Scar Scale score .
-RESULTS	No statistically significant difference was found regarding complications , including graft necrosis , graft detachment , or seroma formation .
-RESULTS	At week 8 , significantly lower Vancouver Scar Scale scores for vascularity , pliability , height , and total score were found in group A compared with group B.
-RESULTS	At week 12 , lower scores for pliability and height and total scores were identified in group A compared with group B.
-CONCLUSIONS	For cases with traumatic full-thickness skin defects on the extremities , a statistically significant better result was achieved with cograft of acellular dermal matrix with autologous split-thickness skin graft than with autologous split-thickness skin graft alone in terms of Vancouver Scar Scale score .
-METHODS	Therapeutic , II .
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-###25439688
-BACKGROUND	If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node , axillary lymph node dissection is the present standard .
-BACKGROUND	Although axillary lymph node dissection provides excellent regional control , it is associated with harmful side-effects .
-BACKGROUND	We aimed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects .
-METHODS	Patients with T1-2 primary breast cancer and no palpable lymphadenopathy were enrolled in the randomised , multicentre , open-label , phase 3 non-inferiority EORTC 10981-22023 AMAROS trial .
-METHODS	Patients were randomly assigned ( 1:1 ) by a computer-generated allocation schedule to receive either axillary lymph node dissection or axillary radiotherapy in case of a positive sentinel node , stratified by institution .
-METHODS	The primary endpoint was non-inferiority of 5-year axillary recurrence , considered to be not more than 4 % for the axillary radiotherapy group compared with an expected 2 % in the axillary lymph node dissection group .
-METHODS	Analyses were by intention to treat and per protocol .
-METHODS	The AMAROS trial is registered with ClinicalTrials.gov , number NCT00014612 .
-RESULTS	Between Feb 19 , 2001 , and April 29 , 2010 , 4823 patients were enrolled at 34 centres from nine European countries , of whom 4806 were eligible for randomisation .
-RESULTS	2402 patients were randomly assigned to receive axillary lymph node dissection and 2404 to receive axillary radiotherapy .
-RESULTS	Of the 1425 patients with a positive sentinel node , 744 had been randomly assigned to axillary lymph node dissection and 681 to axillary radiotherapy ; these patients constituted the intention-to-treat population .
-RESULTS	Median follow-up was 61 years ( IQR 41-80 ) for the patients with positive sentinel lymph nodes .
-RESULTS	In the axillary lymph node dissection group , 220 ( 33 % ) of 672 patients who underwent axillary lymph node dissection had additional positive nodes .
-RESULTS	Axillary recurrence occurred in four of 744 patients in the axillary lymph node dissection group and seven of 681 in the axillary radiotherapy group .
-RESULTS	5-year axillary recurrence was 043 % ( 95 % CI 000-092 ) after axillary lymph node dissection versus 119 % ( 031-208 ) after axillary radiotherapy .
-RESULTS	The planned non-inferiority test was underpowered because of the low number of events .
-RESULTS	The one-sided 95 % CI for the underpowered non-inferiority test on the hazard ratio was 000-527 , with a non-inferiority margin of 2 .
-RESULTS	Lymphoedema in the ipsilateral arm was noted significantly more often after axillary lymph node dissection than after axillary radiotherapy at 1 year , 3 years , and 5 years .
-CONCLUSIONS	Axillary lymph node dissection and axillary radiotherapy after a positive sentinel node provide excellent and comparable axillary control for patients with T1-2 primary breast cancer and no palpable lymphadenopathy .
-CONCLUSIONS	Axillary radiotherapy results in significantly less morbidity .
-BACKGROUND	EORTC Charitable Trust .
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-###25918337
-BACKGROUND	A constructive safety culture is essential for the successful implementation of patient safety improvements .
-OBJECTIVE	To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture .
-METHODS	A three-arm cluster randomised trial was conducted in a mixed method study , studying the effect of administering a patient safety culture questionnaire ( intervention I ) , the questionnaire complemented with a practice-based workshop ( intervention II ) and no intervention ( control ) in 30 general practices in the Netherlands .
-METHODS	The primary outcome , the number of reported incidents , was measured with a questionnaire at baseline and a year after .
-METHODS	Analysis was performed using a negative binomial model .
-METHODS	Secondary outcomes were quality and safety indicators and safety culture .
-METHODS	Mixed effects linear regression was used to analyse the culture questionnaires .
-RESULTS	The number of incidents increased in both intervention groups , to 82 and 224 in intervention I and II respectively .
-RESULTS	Adjusted for baseline number of incidents , practice size and accreditation status , the study showed that practices that additionally participated in the workshop reported 42 ( 95 % confidence interval [ CI ] = 9.81 to 177.50 ) times more incidents compared to the control group .
-RESULTS	Practices that only completed the questionnaire reported 5 ( 95 % CI = 1.17 to 25.49 ) times more incidents .
-RESULTS	There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups .
-CONCLUSIONS	Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents .
-CONCLUSIONS	It is beneficial to invest in a team-wise effort to improve patient safety .
-
-###24957533
-OBJECTIVE	To compare outcomes between elective delivery at 37 weeks of pregnancy and expectant management among pregnant women with mild to moderate chronic hypertension .
-METHODS	In a two-center study , 76 women with mild to moderate chronic hypertension were randomly allocated to planned delivery at 37 completed weeks ( group A ) or expectant management for spontaneous onset of labor or reaching 41 weeks ( group B ) between April 2012 and October 2013 .
-METHODS	Differences were compared by t test , ( 2 ) test , or Fisher exact test .
-METHODS	Odds ratios ( ORs ) with 95 % confidence interval ( CIs ) were determined .
-RESULTS	There were no differences in superimposed pre-eclampsia ( SPE ) , severe hypertension , preterm delivery , placental abruption , oligohydramnios , intrauterine growth restriction , or perinatal mortality between the groups .
-RESULTS	Group B had higher gestational age at delivery ( P = 0.001 ) and birth weight ( P = 0.01 ) , but lower cesarean ( OR 3.4 ; 95 % CI , 1.2-10 .3 ; P = 0.03 ) and neonatal care unit admission ( OR 5.4 ; 95 % CI , 1.4-21 .0 ; P = 0.01 ) rates .
-RESULTS	More women with SPE were diagnosed before than after 37 weeks in group B ( P = 0.01 ) .
-RESULTS	Overall , patients who developed SPE had more adverse pregnancy outcomes than those who did not .
-CONCLUSIONS	Mild to moderate chronic hypertension could be managed expectantly up to 41 weeks if SPE did not develop .
-
-###25111385
-OBJECTIVE	The study compared the transurethral resection in saline ( TURis ) , transurethral vaporization in saline ( TUVis ) , bipolar plasma enucleation of the prostate ( BPEP ) , and open prostatectomy ( OP ) in a single-center , prospective , randomized controlled clinical setting exclusively involving large prostate patients .
-METHODS	During a 4 year enrollment period , 320 cases of prostate volume over 80mL , maximum flow rate ( Qmax ) below 10mL/second , International Prostate Symptom Score ( IPSS ) over 19 , or urinary retention were included in the trial and equally randomized in the four study arms .
-METHODS	Patients were assessed preoperatively as well as at the 1 - , 3 - , 6 - , and 12-month follow-up checkups using the IPSS , quality of life ( QoL ) score , Qmax , postvoiding residual urinary volume ( PVR ) , and prostate-specific antigen ( PSA ) .
-RESULTS	Similar preoperative parameters were established in the four series .
-RESULTS	OP and BPEP were characterized by resembling operating times , while TURis and TUVis displayed prolonged surgical durations .
-RESULTS	TURis emphasized a substantially decreased mean resected tissue weight .
-RESULTS	TUVis showed the lowest mean hemoglobin level drop , followed by TURis and BPEP ( equivalent results ) and finally OP ( highest bleeding ) .
-RESULTS	OP described the longest mean catheterization period and hospital stay , followed by TURis , and afterward by TUVis and BPEP ( similar data ) .
-RESULTS	During the follow-up period , statistically equivalent IPSS , QoL , Qmax , and PVR outcomes were established for OP , BPEP , and TURis .
-RESULTS	TUVis displayed significantly smaller Qmax improvements , but similar other functional features .
-RESULTS	Significantly lower mean PSA levels were determined secondary to OP and BPEP when compared to bipolar resection and subsequently to vaporization .
-CONCLUSIONS	OP and BPEP emphasized the highest surgical efficiency ( prolonged postoperative recovery for OP ) , while TUVis displayed the lowest hemorrhagic risks .
-CONCLUSIONS	On the medium term , generally resembling functional outcomes were determined for the four techniques , with significantly decreased mean PSA values secondary to OP and BPEP .
-
-###24302706
-OBJECTIVE	To analyze discordance between global estimates by patients ( PATGL ) and their physicians ( DOCGL ) according to demographic and self-report variables on a Multidimensional Health Assessment Questionnaire ( MDHAQ ) in patients with many rheumatic diseases seen in usual care .
-METHODS	Each patient completed an MDHAQ at each visit , which includes scores for physical function , pain , and PATGL , each found on the traditional Health Assessment Questionnaire ( HAQ ) , and scores for sleep quality , anxiety , depression , self-report joint count , and fatigue , which are not found on the HAQ .
-METHODS	A random visit of 980 patients with any rheumatic diagnosis was analyzed in 3 categories : PATGL = DOCGL ( within 2 of 10 units ) , PATGL > DOCGL ( by 2 of 10 units ) , and DOCGL > PATGL ( by 2 of 10 units ) , using descriptive statistics and multinomial logistic regression models .
-RESULTS	Patients included 145 with rheumatoid arthritis , 57 with systemic lupus erythematosus , 173 with osteoarthritis , 348 with other inflammatory diseases , and 257 with other noninflammatory diseases .
-RESULTS	Overall , PATGL = DOCGL in 509 ( 52 % ) , PATGL > DOCGL in 371 ( 38 % ) , and DOCGL > PATGL in 100 ( 10 % ) .
-RESULTS	PATGL > DOCGL was associated significantly with older age , female sex , low formal education , Hispanic ethnicity , not working , high MDHAQ physical function and pain scores , and high scores for fatigue , poor sleep , anxiety , depression , and self-report joint count , which are not available on the HAQ .
-RESULTS	Pain and fatigue were significant in a final multinomial logistic regression ; the other variables may raise awareness of discordance to clinicians .
-CONCLUSIONS	Global estimates of patients indicated significantly poorer status than estimates of their physicians in 38 % of 980 patients with rheumatic conditions , and were associated with demographic and MDHAQ scores , 5 of which are not available on the HAQ .
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-###25366674
-OBJECTIVE	Evaluation of the performance of VIA ( visual inspection with acetic acid ) trained nurses to learn colposcopy and the Swede score method to detect cervical lesions by using stationary colposcope or a portable , hand-held colposcope ; the Gynocular , as compared to doctors .
-METHODS	A crossover randomised clinical trial .
-METHODS	The Colposcopy Clinic of Bangabandhu Sheikh Mujib Medical University ( BSMMU ) , Dhaka , Bangladesh .
-METHODS	932 women attending the clinic as either screening nave for VIA screening ( 404 ) or women referred as VIA positive ( 528 ) from other VIA screening centres in the Dhaka region .
-METHODS	VIA trained nurses were trained on-site in colposcopy and in the Swede score systematic colposcopy method .
-METHODS	The Swede score grade cervical acetowhiteness , margins plus surface .
-METHODS	vessel pattern , lesion size and iodine staining .
-METHODS	The women were randomised to start the examination by either a stationary colposcope or the Gynocular .
-METHODS	Swede scores were first obtained by a nurse and the same patient was equally evaluated by a doctor .
-METHODS	Agreement between nurses and doctors in Swede scores was evaluated using the weighted statistic for the Gynocular and standard colposcope .
-METHODS	The ability to predict CIN 2 + ( CIN 2 , CIN 3 and invasive cervical cancer ) using Swede scores was evaluated using receiver-operating characteristic curves .
-RESULTS	The Swede scores obtained by nurses and doctors using the Gynocular and stationary colposcope showed high agreement with a statistic of 0.858 and 0.859 , respectively , and no difference in detecting cervical lesions in biopsy .
-RESULTS	Biopsy detected CIN 2 + in 39 ( 4.2 % ) women .
-CONCLUSIONS	Our study showed that VIA nurses can perform colposcopy .
-CONCLUSIONS	There was no significant differences compared to doctors in detecting cervical lesions by stationary colposcope or the Gynocular using the Swede score system .
-CONCLUSIONS	Swede scores obtained by nurses using the Gynocular could offer an accurate cervical diagnostic approach in low resource settings .
-BACKGROUND	ISRCTN53264564 .
-
-###24854817
-BACKGROUND	Unhealthy weight loss practices are common among female college students .
-BACKGROUND	It is unknown if these practices are also most common among women in the subset of overweight or obese college students or if these practices are related to depression .
-BACKGROUND	We examined the relationship between gender , depression , and unhealthy weight loss practices among overweight or obese college students .
-METHODS	Students ( body mass index between 25.0 and 34.9 kg/m ( 2 ) ) from three Southern California universities ( M ( age ) = 22 years , SD = 4 ; 70 % women ) were recruited from May 2011 to May 2012 for participation in a weight loss clinical trial ( N = 404 ) .
-METHODS	Logistic regressions were performed with baseline data to assess the cross-sectional relationship between self-reported unhealthy weight loss practices and gender and depression as measured by the Center for Epidemiologic Studies Depression short form .
-RESULTS	Twenty-nine percent of participants reported engaging in at least one unhealthy weight loss behavior ( e.g. , fasting , purging ) over the last 30 days , with no differences by gender .
-RESULTS	Self-report of at least one unhealthy weight loss behavior was associated with report of symptoms of depression ( e ( B ) = 1.14 [ confidence interval , CI : 1.08-1 .20 ] ) , adjusting for potential confounders .
-RESULTS	Interactions between gender and depression were not significant ( e ( B ) = 1.04 [ CI : 0.93-1 .16 ] ) .
-CONCLUSIONS	Among an overweight or obese sample of college students , unhealthy weight loss practices were equally common in both genders , and students with depressive symptomatology were at greatest risk .
-CONCLUSIONS	Obesity interventions targeting overweight or obese college students should educate both men and women about the dangers of unhealthy weight loss practices .
-CONCLUSIONS	In addition , screening for depression can help identify students who would benefit from additional supportive and coping strategies and resources .
-
-###24884424
-BACKGROUND	Provision of mother 's own milk is the optimal way to feed infants , including very low birth weight infants ( VLBW , < 1500 g ) .
-BACKGROUND	Importantly for VLBW infants , who are at elevated risk of neurologic sequelae , mother 's own milk has been shown to enhance neurocognitive development .
-BACKGROUND	Unfortunately , the majority of mothers of VLBW infants are unable to provide an adequate supply of milk and thus supplementation with formula or donor milk is necessary .
-BACKGROUND	Given the association between mother 's own milk and neurodevelopment , it is important to ascertain whether provision of human donor milk as a supplement may yield superior neurodevelopmental outcomes compared to formula.Our primary hypothesis is that VLBW infants fed pasteurized donor milk compared to preterm formula as a supplement to mother 's own milk for 90 days or until hospital discharge , whichever comes first , will have an improved cognitive outcome as measured at 18 months corrected age on the Bayley Scales of Infant Development , 3 ( rd ) ed .
-BACKGROUND	Secondary hypotheses are that the use of pasteurized donor milk will : ( 1 ) reduce a composite of death and serious morbidity ; ( 2 ) support growth ; and ( 3 ) improve language and motor development .
-BACKGROUND	Exploratory research questions include : Will use of pasteurized donor milk : ( 1 ) influence feeding tolerance and nutrient intake ( 2 ) have an acceptable cost effectiveness from a comprehensive societal perspective ?
-METHODS	DoMINO is a multi-centre , intent-to-treat , double blinded , randomized control trial .
-METHODS	VLBW infants ( n = 363 ) were randomized within four days of birth to either ( 1 ) pasteurized donor milk or ( 2 ) preterm formula whenever mother 's own milk was unavailable .
-METHODS	Study recruitment began in October 2010 and was completed in December 2012 .
-METHODS	The 90 day feeding intervention is complete and long-term follow-up is underway .
-CONCLUSIONS	Preterm birth and its complications are a leading cause long-term morbidity among Canadian children .
-CONCLUSIONS	Strategies to mitigate this risk are urgently required .
-CONCLUSIONS	As mother 's own milk has been shown to improve neurodevelopment , it is essential to ascertain whether pasteurized donor milk will confer the same advantage over formula without undue risks and at acceptable costs .
-CONCLUSIONS	Knowledge translation from this trial will be pivotal in setting donor milk policy in Canada and beyond .
-BACKGROUND	ISRCTN35317141 ; Registered 10 August 2010 .
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-###24951164
-OBJECTIVE	To analyse late morbidity and mortality in pre and post-menopausal breast cancer patients treated with postmastectomy radiotherapy , with emphasis on side-effects from the heart , cerebrovascular and respiratory systems .
-METHODS	Long term follow-up of two randomised , clinical trials with 1100 patients was carried out .
-METHODS	Pre-menopausal women were allocated to radiotherapy ( RT ) , RT + oral cyclophosphamide ( RT+C ) or cyclophosphamide only ( C ) .
-METHODS	Post-menopausal women were allocated to RT , RT+T amoxifen for one year ( RT+T am ) or tamoxifen only ( Tam ) .
-METHODS	Information on admission to hospital , mortality and causes of death was obtained from national registers .
-RESULTS	After 25 years , adding RT to cyclophosphamide in pre-menopausal women raised the mortality from heart disease from zero to 0.8 % ( p = 0.04 ) .
-RESULTS	In post-menopausal women , adding RT to Tam raised the mortality from heart disease from 10.5 % to 18.4 % ( p = 0.005 ) .
-RESULTS	In post-menopausal women mortality due to cerebrovascular disease increased from 3.4 % to 8.7 % by adding RT to Tam ( p = 0.015 ) .
-RESULTS	The differences were not evident until in the second decade of follow-up .
-RESULTS	In spite of differences in specific causes of death , there were no significant differences between the treatment arms concerning morbidity or overall mortality .
-CONCLUSIONS	Postmastectomy radiotherapy to the chest wall and loco-regional lymph nodes including the parasternal lymph nodes as delivered in the end of the seventies did not reduce overall mortality , but gave a significantly increased risk of death from heart and cerebrovascular disease , which appeared during the second decade after radiotherapy .
-
-###24821009
-OBJECTIVE	Gemcitabine combined with carboplatin ( GC ) is a widely used regimen for advanced non-small cell lung cancer ( NSCLC ) , but clinical outcome is still hampered by its toxicity .
-OBJECTIVE	We conducted a randomized phase II study of GC and compared biweekly versus standard schedules in patients with advanced NSCLC with respect to toxicity and outcome .
-METHODS	Forty patients with stage IIIB or IV NSCLC were randomized to receive either a biweekly regimen of GC [ gemcitabine ( 1,000 mg/m ( 2 ) on days 1 and 14 ) and carboplatin ( area under the concentration-time curve , AUC = 3 on days 1 and 14 ) ] every 28 days or a standard regimen of GC [ gemcitabine ( 1,000 mg/m ( 2 ) on days 1 and 8 ) and carboplatin ( AUC = 5 on day 1 ) ] every 21 days .
-METHODS	These cycles were repeated until disease progression .
-RESULTS	Response rates were 55 % for the biweekly regimen and 40 % for the standard regimen .
-RESULTS	Median overall and progression-free survival times were 19.7 and 6.2 months , respectively , for the biweekly regimen , and 11.8 and 2.8 months , respectively , for the standard GC regimen .
-RESULTS	Hematologic toxicity was prominent .
-RESULTS	However , the incidence of grade 1 or 2 thrombocytopenia was significantly lower in the biweekly than in the standard GC regimen ( p < 0.05 ) .
-RESULTS	Nonhematologic toxicity was mild .
-CONCLUSIONS	A biweekly GC regimen was better tolerated than a standard GC regimen in patients with advanced NSCLC .
-
-###25271603
-BACKGROUND	A window of opportunity has been suggested for reducing the risk of celiac disease by introducing gluten to infants at 4 to 6 months of age .
-METHODS	We performed a multicenter , randomized , double-blind , placebo-controlled dietary-intervention study involving 944 children who were positive for HLA-DQ2 or HLA-DQ8 and had at least one first-degree relative with celiac disease .
-METHODS	From 16 to 24 weeks of age , 475 participants received 100 mg of immunologically active gluten daily , and 469 received placebo .
-METHODS	Anti-transglutaminase type 2 and antigliadin antibodies were periodically measured .
-METHODS	The primary outcome was the frequency of biopsy-confirmed celiac disease at 3 years of age .
-RESULTS	Celiac disease was confirmed by means of biopsies in 77 children .
-RESULTS	To avoid underestimation of the frequency of celiac disease , 3 additional children who received a diagnosis of celiac disease according to the 2012 European Society for Pediatric Gastroenterology , Hepatology , and Nutrition diagnostic criteria ( without having undergone biopsies ) were included in the analyses ( 80 children ; median age , 2.8 years ; 59 % were girls ) .
-RESULTS	The cumulative incidence of celiac disease among patients 3 years of age was 5.2 % ( 95 % confidence interval [ CI ] , 3.6 to 6.8 ) , with similar rates in the gluten group and the placebo group ( 5.9 % [ 95 % CI , 3.7 to 8.1 ] and 4.5 % [ 95 % CI , 2.5 to 6.5 ] , respectively ; hazard ratio in the gluten group , 1.23 ; 95 % CI , 0.79 to 1.91 ) .
-RESULTS	Rates of elevated levels of anti-transglutaminase type 2 and antigliadin antibodies were also similar in the two study groups ( 7.0 % [ 95 % CI , 4.7 to 9.4 ] in the gluten group and 5.7 % [ 95 % CI , 3.5 to 7.9 ] in the placebo group ; hazard ratio , 1.14 ; 95 % CI , 0.76 to 1.73 ) .
-RESULTS	Breast-feeding , regardless of whether it was exclusive or whether it was ongoing during gluten introduction , did not significantly influence the development of celiac disease or the effect of the intervention .
-CONCLUSIONS	As compared with placebo , the introduction of small quantities of gluten at 16 to 24 weeks of age did not reduce the risk of celiac disease by 3 years of age in this group of high-risk children .
-CONCLUSIONS	( Funded by the European Commission and others ; PreventCD Current Controlled Trials number , ISRCTN74582487 . )
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-###25877422
-OBJECTIVE	To evaluate the efficacy and safety of auto-crosslinked hyaluronic acid ( HA ) gel for preventing intrauterine adhesion ( IUA ) after hysteroscopic adhesiolysis .
-METHODS	A prospective , randomized , double blinded and controlled clinical trial ( level I ) was performed .
-METHODS	According to American Fertility Society ( AFS ) scoring system , 120 patients ( treatment group : 60 cases , control group : 60 cases ) with moderate to severe IUA were enrolled .
-METHODS	Upon completion of adhesiolysis , a Foley balloon catheter was first introduced into the uterine cavity and then 3 ml of auto-crosslinked HA gel for patients in the treatment group ; patients in the control group , however , only received Foley balloon catheter .
-METHODS	Second-look hysteroscopic examination was performed to all patients at 3 months postoperatively for evaluation of IUA .
-METHODS	Primary endpoint was the reduction rate of IUA at 3 months after surgery .
-METHODS	The secondary endpoints include total AFS score , score of each individual AFS category .
-RESULTS	At 3 months after surgery , auto-crosslinked HA gel resulted in significantly higher effective rate for reduction of adhesion , the effective rate were 76 % ( 42/55 ) and 48 % ( 27/56 ) respectively ( P = 0.000 9 ) ; the total AFS score of treatment group was 2.1 1.1 , and significantly lower than that of control group ( 3.7 2.5 , P = 0.000 8 ) .
-RESULTS	Application of auto-crosslinked HA gel after surgery significantly enhanced the improvement for each individual patient with regard to their adhesive type and menstrual pattern ( P = 0.037 8 , P = 0.000 4 ) .
-RESULTS	The treatment group had significantly lower proportion of patients with moderate to severe adhesive stages than that of control group [ 13 % ( 7/55 ) versus 38 % ( 21/56 ) , P = 0.000 6 ] .
-RESULTS	No adverse events and complications were observed .
-CONCLUSIONS	Auto-crosslinked HA gel coule be able to reduce IUA , decrease adhesion severity , and improve menopause postoperatively .
-CONCLUSIONS	This absorbable auto-crosslinked HA gel is proposed as a barrier for preventing IUA after intrauterine procedures .
-
-###25404215
-BACKGROUND	Suicidal behaviour and deliberate self-harm are common among adults .
-BACKGROUND	Research indicates that maintaining contact either via letter or postcard with at-risk adults following discharge from care services can reduce reattempt risk .
-BACKGROUND	Feasibility trials demonstrated that intervention through text message was also effective in preventing suicide repetition amongst suicide attempters .
-BACKGROUND	The aim of the current study is to investigate the effect of text message intervention versus traditional treatment on reducing the risk of suicide attempt repetition among adults after self-harm .
-METHODS	The study will be a 2-year multicentric randomized controlled trial conducted by the Brest University Hospital , France .
-METHODS	Participants will be adults discharged after self-harm , from emergency services or after a short hospitalization .
-METHODS	Participants will be recruited over a 12-month period .
-METHODS	The intervention is comprised of an SMS that will be sent at h48 , D7 , D15 and monthly .
-METHODS	The text message enquires about the patients ' well-being and includes information regarding individual sources of help and evidence-based self help strategies .
-METHODS	Participants will be assessed at the baseline , month 6 and 13 .
-METHODS	As primary endpoint , we will assess the number of patients who reattempt suicide in each group at 6 months .
-METHODS	As secondary endpoints , we will assess the number of patients who reattempt suicide at 13 month , the number of suicide attempts in the intervention and control groups at 6 and 13 month , the number of death by suicide in the intervention and control groups at month 6 and 13 .
-METHODS	In both groups , suicidal ideations , will be assessed at the baseline , month 6 and 13 .
-METHODS	Medical costs and satisfaction will be assessed at month 13 .
-CONCLUSIONS	This paper describes the design and deployment of a trial SIAM ; an easily reproducible intervention that aims to reduce suicide risk in adults after self-harm .
-CONCLUSIONS	It utilizes several characteristics of interventions that have shown a significant reduction in the number of suicide reattempts .
-CONCLUSIONS	We propose to assess its efficacy in reducing suicide reattempt in the suicide attempter ( SA ) population .
-BACKGROUND	The study was registered on Clinical Trials Registry ( clinicaltrials.gov ) : NCT02106949 , registered on 06 June 2014 .
-
-###24666591
-BACKGROUND	Stroke is a leading cause of death and disability internationally .
-BACKGROUND	One of the three effective interventions in the acute phase of stroke care is thrombolytic therapy with tissue plasminogen activator ( tPA ) , if given within 4.5 hours of onset to appropriate cases of ischaemic stroke .
-OBJECTIVE	To test the effectiveness of a multi-component multidisciplinary collaborative approach compared to usual care as a strategy for increasing thrombolysis rates for all stroke patients at intervention hospitals , while maintaining accepted benchmarks for low rates of intracranial haemorrhage and high rates of functional outcomes for both groups at three months .
-METHODS	A cluster randomised controlled trial of 20 hospitals across 3 Australian states with 2 groups : multi - component multidisciplinary collaborative intervention as the experimental group and usual care as the control group .
-METHODS	The intervention is based on behavioural theory and analysis of the steps , roles and barriers relating to rapid assessment for thrombolysis eligibility ; it involves a comprehensive range of strategies addressing individual-level and system-level change at each site .
-METHODS	The primary outcome is the difference in tPA rates between the two groups post-intervention .
-METHODS	The secondary outcome is the proportion of tPA treated patients in both groups with good functional outcomes ( modified Rankin Score ( mRS < 2 ) and the proportion with intracranial haemorrhage ( mRS 2 ) , compared to international benchmarks .
-CONCLUSIONS	TIPS will trial a comprehensive , multi-component and multidisciplinary collaborative approach to improving thrombolysis rates at multiple sites .
-CONCLUSIONS	The trial has the potential to identify methods for optimal care which can be implemented for stroke patients during the acute phase .
-CONCLUSIONS	Study findings will include barriers and solutions to effective thrombolysis implementation and trial outcomes will be published whether significant or not .
-BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12613000939796 .
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-###24306705
-BACKGROUND	The purpose of the present study was to quantify perfusion to the femoral head and head-neck junction using gadolinium-enhanced magnetic resonance imaging following three surgical dislocations of the hip ( trochanteric flip osteotomy , standard posterior approach , and modified posterior approach ) .
-METHODS	The medial femoral circumflex artery was cannulated in fifty fresh-frozen cadaveric hips ( twenty-five pelvic specimens ) .
-METHODS	One hip on each pelvic specimen was randomly chosen to undergo one of the three surgical dislocations , and the contralateral hip was used as a control .
-METHODS	Gadolinium enhancement on the magnetic resonance imaging scan was quantified in both the femoral head and head-neck junction by volumetric analysis using custom magnetic resonance imaging analysis software .
-METHODS	A polyurethane compound was then injected , and gross dissection was performed to assess the extraosseous vasculature .
-RESULTS	Magnetic resonance imaging quantification revealed that the trochanteric flip osteotomy group maintained almost full perfusion ( mean , 96 % for the femoral head and 98 % for the head-neck junction ) .
-RESULTS	The standard posterior approach almost completely compromised perfusion ( mean , 4 % for the femoral head and 8 % for the head-neck junction ) .
-RESULTS	Six specimens in the modified posterior approach group demonstrated partial perfusion ( mean , 32 % in the femoral head and 26 % in the head-neck junction ) .
-RESULTS	Three specimens in the modified posterior approach group demonstrated almost full perfusion ( mean , 96 % in the femoral head and 97 % in the head-neck junction ) .
-RESULTS	Gross dissection revealed that all specimens in the standard posterior approach group and seven of ten in the modified posterior approach group sustained disruption of the ascending branch of the medial femoral circumflex artery .
-RESULTS	All specimens in the standard posterior approach group demonstrated disruption of the inferior retinacular artery .
-RESULTS	The inferior retinacular artery remained intact in nine of ten specimens in the modified posterior approach group .
-RESULTS	One specimen in the modified posterior approach group that had disruption of both the ascending medial femoral circumflex artery and inferior retinacular artery demonstrated a substantial decrease in perfusion ( 7 % in the femoral head and 5 % in the head-neck junction ) .
-CONCLUSIONS	The trochanteric flip osteotomy preserves the vascular supply to the femoral head and head-neck junction .
-CONCLUSIONS	The standard posterior approach disrupts the vascular supply and should be completely abandoned for surgical hip dislocation .
-CONCLUSIONS	Despite reduced enhancement , substantial perfusion of the femoral head and head-neck junction was present in the modified posterior approach group , likely because of the preservation of the inferior retinacular artery .
-CONCLUSIONS	The modified posterior approach produced variable results , indicating that improvement to the modified posterior approach is needed .
-CONCLUSIONS	Our study provides previously unreported quantitative magnetic resonance imaging data on the perfusion to the femoral head and head-neck junction during common surgical approaches to the hip .
-
-###24645908
-BACKGROUND	Whole genome sequencing ( WGS ) is already being used in certain clinical and research settings , but its impact on patient well-being , health-care utilization , and clinical decision-making remains largely unstudied .
-BACKGROUND	It is also unknown how best to communicate sequencing results to physicians and patients to improve health .
-BACKGROUND	We describe the design of the MedSeq Project : the first randomized trials of WGS in clinical care .
-METHODS	This pair of randomized controlled trials compares WGS to standard of care in two clinical contexts : ( a ) disease-specific genomic medicine in a cardiomyopathy clinic and ( b ) general genomic medicine in primary care .
-METHODS	We are recruiting 8 to 12 cardiologists , 8 to 12 primary care physicians , and approximately 200 of their patients .
-METHODS	Patient participants in both the cardiology and primary care trials are randomly assigned to receive a family history assessment with or without WGS .
-METHODS	Our laboratory delivers a genome report to physician participants that balances the needs to enhance understandability of genomic information and to convey its complexity .
-METHODS	We provide an educational curriculum for physician participants and offer them a hotline to genetics professionals for guidance in interpreting and managing their patients ' genome reports .
-METHODS	Using varied data sources , including surveys , semi-structured interviews , and review of clinical data , we measure the attitudes , behaviors and outcomes of physician and patient participants at multiple time points before and after the disclosure of these results .
-CONCLUSIONS	The impact of emerging sequencing technologies on patient care is unclear .
-CONCLUSIONS	We have designed a process of interpreting WGS results and delivering them to physicians in a way that anticipates how we envision genomic medicine will evolve in the near future .
-CONCLUSIONS	That is , our WGS report provides clinically relevant information while communicating the complexity and uncertainty of WGS results to physicians and , through physicians , to their patients .
-CONCLUSIONS	This project will not only illuminate the impact of integrating genomic medicine into the clinical care of patients but also inform the design of future studies .
-BACKGROUND	ClinicalTrials.gov identifier NCT01736566 .
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-###25494860
-BACKGROUND	It is unknown whether leptin and peptide YY ( PYY ) influence changes in resting energy expenditure ( REE ) , independently of fat mass ( FM ) and fat-free mass ( FFM ) in addition to changes in other energy expenditure ( EE ) components during weight loss .
-OBJECTIVE	The objective of the study was to examine the relationships between leptin , PYY , and body composition with different EE components before and after weight loss and whether changes in leptin and PYY were associated with differences in predicted vs measured REE after the intervention .
-METHODS	This was a randomized controlled design .
-METHODS	The study was conducted in a laboratory .
-METHODS	Participants were ninety-three overweight/obese postmenopausal women ( aged 58.1 4.8 y ; body mass index 32.1 4.3 kg/m ( 2 ) ) .
-METHODS	Interventions included a 6-month caloric restriction diet alone or caloric restriction diet + resistance training .
-METHODS	Body composition ( dual energy x-ray absorptiometry ) , REE ( indirect calorimetry ) , total EE ( TEE ; doubly labeled water ) , and fasting leptin and total PYY before and after weight loss were measured .
-RESULTS	Both interventions yielded significant decreases in weight , FFM , REE , and leptin , whereas a significant time group interaction was noted for FM ( greater decrease in FM in the diet + resistance training group ) ( P < .05 for all outcomes ) .
-RESULTS	No significant differences in TEE , physical activity EE , and PYY were noted between baseline and after the intervention .
-RESULTS	Age , FFM , leptin , and PYY were the best predictors of baseline REE ( R ( 2 ) = 0.77 ; P = .0001 ) , whereas age , FFM , and FM were associated with REE after the intervention ( R ( 2 ) = 0.88 ; P = .0001 ) .
-RESULTS	The same predictors , except for leptin , were significantly related to TEE at baseline ( R ( 2 ) = 0.70 ; P = .0001 ) and after the intervention ( R ( 2 ) = 0.29 ; P = .0001 ) , whereas only PYY was a significant predictor of physical activity EE at baseline and after the intervention .
-RESULTS	Changes in FM and leptin accounted for 27 % of the variance in REE ( P = .0001 ) .
-RESULTS	Greater predicted vs measured REE was noted after the intervention ( P = .02 ) .
-RESULTS	However , leptin and PYY were not significant predictors of the differences between postintervention measurement and predicted REE .
-CONCLUSIONS	Leptin and FM were strong contributors to changes in REE .
-CONCLUSIONS	However , leptin and PYY were not significant predictors of the differences between predicted and measured REE after the intervention .
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-###24749303
-OBJECTIVE	To evaluate the influence of epidural analgesia and lumbar paravertebral block on the structure of the delivery , the fetus and newborn , and the quality and duration of analgesia .
-METHODS	Patients were randomized into three groups , 30 patients in each group .
-METHODS	In the group-1 patients received epidural analgesia ( EA ) , in the group-2 -- paravertebral block ( PVB ) , in the group-3 patients refused pain relief in labor .
-METHODS	Pain was assessed by VAS .
-METHODS	Length of the first and second stage of labor the impact on the CTG and fetal blood gases from the umbilical cord of newborns in the first minute of life were fixed .
-METHODS	Data were analyzed by Mann-Whitney U test and presented as median ( 25th-75th percentiles ) .
-RESULTS	In both groups of patients in pain reduction was significant adjustment contractions and after 1 hour was 94.5 % in EA , and PVB group -- 78.7 % of the initial values .
-RESULTS	Under EA opening cervix was statistically significantly greater than in the PVB ( 192.5 ( 145 , 302 ) vs 172.5 ( 112 , 210 ) min ) p < 0.05 .
-RESULTS	Second stage of labor was also shorter in the PVB than in the EA ( 30.4 ( 10.2 , 46.5 ) vs 59.8 ( 40.2 , 81.5 ) min ) , in the control group it was -- 40.6 ( 21.3 , 55.4 ) min , p < 0.05 .
-RESULTS	PVB was observed in the group of more stable hemodynamics than in the EA for the entire period of observation .
-RESULTS	There were no adverse effects on the fetus and the newborn in the arms of the study .
-CONCLUSIONS	The proposed lumbar paravertebral block is simple to perform , is effective in reducing pain in the first stage of labor does not require continuous hemodynamic monitoring may be used for the treatment of birth dystocia and is a good alternative when the use of epidural analgesia during labor is limited .
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-###24290112
-OBJECTIVE	To study the effect on maternal weight gain of a supervised light - to moderate-intensity exercise-based intervention performed from the ninth week of pregnancy .
-METHODS	A total of 962 healthy pregnant women were randomly assigned to a standard care or exercise intervention group conducted between September 1 , 2007 , and January 31 , 2011 .
-METHODS	The intervention included light - to moderate-intensity aerobic and resistance exercises performed 3 days a week ( 50-55 minutes per session ) .
-METHODS	Excessive gestational weight gain was calculated on the basis of the 2009 Institute of Medicine ( IOM ) recommendations .
-METHODS	Gestational body weight gain was calculated on the basis of the weight measured at the first prenatal visit ( fifth to sixth weeks of gestation ) and weight measured at the last visit to the clinic before delivery .
-METHODS	Women were categorized into normal weight or overweight or obese .
-RESULTS	Women in the intervention group gained less weight ( adjusted mean difference , 1.039 kg ; 95 % CI , 0.534-1 .545 kg ; P < .001 ) and were less likely to gain weight above the IOM recommendations ( odds ratio , 0.625 ; 95 % CI , 0.461-0 .847 ) compared with those in the standard care group .
-RESULTS	The main treatment effects according to body mass index category were that normal weight women in the intervention group gained less weight ( adjusted mean difference , 1.393 kg ; 95 % CI , 0.813-1 .972 kg ; P < .001 ) and were less likely to gain weight above the IOM recommendations ( odds ratio , 0.508 ; 95 % CI , 0.334-0 .774 ) than normal weight women who received standard care .
-RESULTS	No significant treatment effect was observed in overweight or obese women .
-CONCLUSIONS	Supervised exercise of light to moderate intensity can be used to prevent excessive gestational weight gain , especially in normal weight women .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01790347 .
-
-###24492859
-BACKGROUND	Improving the health of school-aged children can yield substantial benefits for cognitive development and educational achievement .
-BACKGROUND	However , there is limited experimental evidence of the benefits of alternative school-based malaria interventions or how the impacts of interventions vary according to intensity of malaria transmission .
-BACKGROUND	We investigated the effect of intermittent screening and treatment ( IST ) for malaria on the health and education of school children in an area of low to moderate malaria transmission .
-RESULTS	A cluster randomised trial was implemented with 5,233 children in 101 government primary schools on the south coast of Kenya in 2010-2012 .
-RESULTS	The intervention was delivered to children randomly selected from classes 1 and 5 who were followed up for 24 months .
-RESULTS	Once a school term , children were screened by public health workers using malaria rapid diagnostic tests ( RDTs ) , and children ( with or without malaria symptoms ) found to be RDT-positive were treated with a six dose regimen of artemether-lumefantrine ( AL ) .
-RESULTS	Given the nature of the intervention , the trial was not blinded .
-RESULTS	The primary outcomes were anaemia and sustained attention .
-RESULTS	Secondary outcomes were malaria parasitaemia and educational achievement .
-RESULTS	Data were analysed on an intention-to-treat basis .
-RESULTS	During the intervention period , an average of 88.3 % children in intervention schools were screened at each round , of whom 17.5 % were RDT-positive .
-RESULTS	80.3 % of children in the control and 80.2 % in the intervention group were followed-up at 24 months .
-RESULTS	No impact of the malaria IST intervention was observed for prevalence of anaemia at either 12 or 24 months ( adjusted risk ratio [ Adj.RR ] : 1.03 , 95 % CI 0.93-1 .13 , p = 0.621 and Adj.RR : 1.00 , 95 % CI 0.90-1 .11 , p = 0.953 ) respectively , or on prevalence of P. falciparum infection or scores of classroom attention .
-RESULTS	No effect of IST was observed on educational achievement in the older class , but an apparent negative effect was seen on spelling scores in the younger class at 9 and 24 months and on arithmetic scores at 24 months .
-CONCLUSIONS	In this setting in Kenya , IST as implemented in this study is not effective in improving the health or education of school children .
-CONCLUSIONS	Possible reasons for the absence of an impact are the marked geographical heterogeneity in transmission , the rapid rate of reinfection following AL treatment , the variable reliability of RDTs , and the relative contribution of malaria to the aetiology of anaemia in this setting .
-BACKGROUND	www.ClinicalTrials.gov NCT00878007 .
-
-###25604760
-BACKGROUND	This study intended to implement a novel intervention strategy , in Brazil , using an ecohealth approach and analyse its effectiveness and costs in reducing Aedes aegypti vector density as well as its acceptance , feasibility and sustainability .
-BACKGROUND	The intervention was conducted from 2012 to 2013 in the municipality of Fortaleza , northeast Brazil .
-METHODS	A cluster randomized controlled trial was designed by comparing ten intervention clusters with ten control clusters where routine vector control activities were conducted .
-METHODS	The intervention included : community workshops ; community involvement in clean-up campaigns ; covering the elevated containers and in-house rubbish disposal without larviciding ; mobilization of schoolchildren and senior inhabitants ; and distribution of information , education and communication ( IEC ) materials in the community .
-RESULTS	Differences in terms of social participation , commitment and leadership were present in the clusters .
-RESULTS	The results showed the effectiveness of the intervention package in comparison with the routine control programme .
-RESULTS	Differences regarding the costs of the intervention were reasonable and could be adopted by public health services .
-CONCLUSIONS	Embedding social participation and environmental management for improved dengue vector control was feasible and significantly reduced vector densities .
-CONCLUSIONS	Such a participatory ecohealth approach offers a promising alternative to routine vector control measures .
-
-###25567150
-OBJECTIVE	To evaluate the effect of olmesartan medoxomil tablets ( olmesartan ) in comparison with Olmetec on 24 h ambulatory blood pressure ( ABPM ) and blood pressure variability ( BPV ) in patients with mild to moderate hypertension .
-METHODS	A randomized , double-blind , double-mimic controlled trial was performed.Forty-eight patients with mild to moderate essential hypertension were randomly into treatment group ( olmesartan ) and control group ( Olmetec ) for eight weeks .
-METHODS	The ABPM was taken before and at the end of the trial .
-RESULTS	After eight weeks , treatment with olmesartan induced a significant reduction in ABPM in patients [ ( 9 3 ) / ( 11 3 ) mmHg ( 1 mmHg = 0.133 kPa ) ] , which is similar with the reduction by Olmetec [ ( 9 4 ) / ( 9 5 ) mmHg ] , P > 0.05 .
-RESULTS	This situation holds for BPV with the standard deviations of 24 h , systolic blood pressure/diastolic blood pressure of pre-treatment and pro-treatment were ( 10 2 ) / ( 11 3 ) mmHg vs ( 10 3 ) / ( 12 2 ) mmHg in olmesartan group , and ( 10 3 ) / ( 11 3 ) mmHg vs ( 12 3 ) / ( 12 4 ) mmHg in Olmetec group .
-RESULTS	( 3 ) There is no difference in the rate of adverse event between olmesartan ( 10.42 % ) and Olmetec ( 8.33 % ) treatment ( P > 0.05 ) .
-CONCLUSIONS	Similar to Olmetec , treatment with olmesartan once daily can significantly reduce ABPM in patients with mild to moderate essential hypertension .
-
-###24351402
-BACKGROUND	The purpose of this study was to investigate the usefulness of a hydrocolloid dressing containing ceramide for hand-foot skin reaction ( HFSR ) on the soles of the feet in metastatic renal cell carcinoma ( RCC ) patients treated with sorafenib .
-METHODS	Patients with grade 1 HFSR on the soles of the feet were randomly assigned in to two groups .
-METHODS	One group received a hydrocolloid dressing containing ceramide ( arm A ) and the other received 10 % urea cream ( arm B ) .
-METHODS	Patients in both groups applied treatment to the affected sites on the soles of the feet , but not to the hands .
-METHODS	The primary end point was the incidence of grade 2 or 3 HFSR on the soles of the feet in the first 4 weeks .
-RESULTS	Thirty-three patients were assessed ( 17 in arm A and 16 in arm B ) , and there were no significant differences in baseline characteristics between the two groups .
-RESULTS	During the observation period of this study , grade 2 or 3 HFSR on the soles of the feet was found in 29 % of patients in arm A and was significantly less than the 69 % in arm B ( P = 0.03 ) .
-RESULTS	The incidence of HFSR on the hands , however , was similar in both arms .
-RESULTS	The median time to grade 2 or 3 HFSR on the soles of the feet was also significantly longer in arm A than in arm B ( P = 0.03 ) .
-CONCLUSIONS	These results indicate that a hydrocolloid dressing containing ceramide prevented the worsening of HFSR caused by sorafenib in metastatic RCC patients .
-BACKGROUND	UMIN000002016 .
-
-###25563584
-BACKGROUND	Spinal cord injury ( SCI ) leads to a profound muscular atrophy , bone loss and bone fragility .
-BACKGROUND	While there is evidence that exercising paralysed muscles may lead to reversal of muscle atrophy in the chronic period after SCI , there is little evidence that exercise can prevent muscle changes early after injury .
-BACKGROUND	Moreover , whether exercise can prevent bone loss and microarchitectural decay is not clear .
-METHODS	A multi-centre , parallel group , assessor-blinded randomised controlled trial will be conducted .
-METHODS	Fifty participants with acute spinal cord injury will be recruited from four SCI units in Australia and New Zealand .
-METHODS	Participants will be stratified by site and AIS status and randomised to an experimental or control group .
-METHODS	Experimental participants will receive a 12-week programme of functional electrical stimulation ( FES ) - assisted cycling .
-METHODS	Control participants will receive a 12-week programme of passive cycling .
-METHODS	The primary outcome is muscle cross-sectional area of the thigh and calf measured using magnetic resonance images ( MRI ) of the leg .
-METHODS	Secondary outcomes include serum biomarkers of SCI osteoporosis ( sclerostin , P1NP and - CTX ) , markers of immune function ( IL-6 , IL-10 , FGF2 , INF - , TNF - ) , neurological function , body composition , depression and quality of life .
-METHODS	Leg MRIs will be measured by a single blinded assessor based in Melbourne .
-METHODS	Serum samples will be analysed in a central laboratory .
-METHODS	All other characteristics will be measured at baseline and 12weeks by blinded and trained assessors at each site .
-METHODS	The first participant was randomised on 27 November 2012 .
-CONCLUSIONS	The results of this trial will determine the relative effectiveness of a 12-week programme of FES-assisted cycling versus passive cycling in preventing muscle atrophy and maintaining skeletal integrity after spinal cord injury .
-BACKGROUND	ACTRN12611001079932 ( 18 October 2011 ) .
-
-###24874200
-BACKGROUND	Hospitalization for acute heart failure ( HF ) is associated with high rates of subsequent mortality and readmission .
-BACKGROUND	We assessed the influence of the time interval between previous HF hospitalization and randomization in the Candesartan in Heart failure : Reduction in Mortality and morbidity ( CHARM ) trials on clinical outcomes in patients with both reduced and preserved ejection fraction .
-RESULTS	CHARM enrolled 7599 patients with New York Heart Association class II to IV HF , of whom 5426 had a history of previous HF hospitalization .
-RESULTS	Cox proportional hazards regression models were used to assess the association between time from previous HF hospitalization and randomization and the primary outcome of cardiovascular death or unplanned admission to hospital for the management of worsening HF during a median of 36.6 months .
-RESULTS	For patients with HF and reduced or preserved ejection fraction , rates of cardiovascular mortality and HF hospitalization were higher among patients with previous HF hospitalization than those without .
-RESULTS	The risk for mortality and hospitalization varied inversely with the time interval between hospitalization and randomization .
-RESULTS	Rates were higher for patients with HF and reduced ejection fraction within each category .
-RESULTS	Event rates for those with HF with preserved ejection fraction and a HF hospitalization in the 6 months before randomization were comparable with the rate in patients with HF and reduced ejection fraction with no previous HF hospitalization .
-CONCLUSIONS	Rates of cardiovascular death or HF hospitalization are greatest in those who have been previously hospitalized for HF .
-CONCLUSIONS	Independent of EF , rates of death and readmission decline as time from HF hospitalization to trial enrollment increased .
-CONCLUSIONS	Recent HF hospitalization identifies a high-risk population for future clinical trials in HF and reduced ejection fraction and HF with preserved ejection fraction .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00634400 .
-
-###24232665
-OBJECTIVE	To study whether Johan Sebastian Bach music has a lowering effect on resting energy expenditure ( REE ) similar to that of Wolfgang Amadeus Mozart music .
-METHODS	Prospective , randomized clinical trial with cross-over in 12 healthy , appropriate weights for gestational age ( GA ) , gavage fed , metabolically stable , preterm infants .
-METHODS	Infants were randomized to a 30-min period of either Mozart or Bach music or no music over 3 consecutive days .
-METHODS	REE was measured every minute by indirect calorimetry .
-RESULTS	Three REE measurements were performed in each of 12 infants at age 2015.8 days .
-RESULTS	Mean GA was 30.172.44 weeks and mean birthweight was 1246239g .
-RESULTS	REE was similar during the first 10-min of all three randomization periods .
-RESULTS	During the next 10-min period , infants exposed to music by Mozart had a trend toward lower REE than when not exposed to music .
-RESULTS	This trend became significant during the third 10-min period .
-RESULTS	In contrast , music by Bach or no music did not affect significantly REE during the whole study .
-RESULTS	On average , the effect size of Mozart music upon REE was a reduction of 7.7 % from baseline .
-CONCLUSIONS	Mozart music significantly lowers REE in preterm infants , whereas Bach music has no similar effect .
-CONCLUSIONS	We speculate that ` Mozart effect ' must be taken into account when incorporating music in the therapy of preterm infants , as not all types of music may have similar effects upon REE and growth .
-
-###25375047
-BACKGROUND	Seroma formation is the most frequent postoperative complication after axillary dissection for breast surgery with an incidence of 10 - 50 % .
-BACKGROUND	This prospective clinical randomized study was carried out to evaluate the Ligasure vessel sealing system and its effect on seromaformation and other complications for axillary dissection .
-METHODS	Between January 2006 and November 2007 , the patients with histopathological diagnosis of breast cancer were analysed prospectively .
-METHODS	The patients with positive sentinel lymph node biopsy or clinical axillary involvement were included in the study , and the patients who underwent neoadjuvant therapy or using anticoagulants have been excluded from the study .
-METHODS	Patients were divided into two study groups.Axillary dissection was performed in the first group by LigaSure and in the second group by linking and electrocautery .
-RESULTS	There were a total of thirty three patients with a mean age of 51.4 + - 13.7 .
-RESULTS	In group one , mean age of patients was 54.1 + - 13.2 and 48.68 + - 14.1 in group two .
-RESULTS	There was no significant statistical difference between the groups regarding age , body mass index , excised tissue weight , tumour size and number of excised lymph nodes .
-RESULTS	The use of Ligasure reduced drainage amount and duration of drain till removal , but increased operative time .
-CONCLUSIONS	There were no significant differences between study groups regarding the complications .
-CONCLUSIONS	LigaSure electrothermal bipolar vessel sealing system can be safely used in axillary dissection as an alternative to traditional methods .
-
-###24246711
-OBJECTIVE	To evaluate whether couples with moderate male infertility should be treated with conventional in vitro fertilization ( IVF ) or intracytoplasmic sperm injection ( ICSI ) .
-METHODS	A total of 249 couples with moderate male infertility undergoing their first IVF/ICSI cycle were enrolled in the study .
-METHODS	The couples were divided into two groups according to the results of semen analysis : moderate oligozoospermia ( O group ) and moderate oligoasthenozoospermia ( OA group ) .
-METHODS	Sibling oocytes were randomized into groups to be inseminated either by conventional IVF or ICSI .
-METHODS	Fertilization rate , embryo quality , implantation rate , and clinical pregnancy rate were examined .
-RESULTS	There was no difference in the fertilization , implantation , and pregnancy rates between conventional IVF and ICSI in either the O group or OA group ( p > 0.05 ) .
-RESULTS	Additionally , in the OA group , the good quality embryo rate was similar after IVF or ICSI ( p > 0.05 ) .
-RESULTS	However , in the O group , the good quality embryo rate was significantly higher after ICSI than after IVF ( p < 0.05 ) .
-CONCLUSIONS	Couples with moderate oligozoospermia or moderate oligoasthenozoospermia did not influence the major indices of IVF .
-CONCLUSIONS	Because of the uncertainties concerning the safety of ICSI , couples with moderate oligozoospermia or moderate oligoasthenozoospermia need not be subjected to this procedure .
-
-###26095467
-BACKGROUND	Venous thromboembolism may be the earliest sign of cancer .
-BACKGROUND	Currently , there is a great diversity in practices regarding screening for occult cancer in a person who has an unprovoked venous thromboembolism .
-BACKGROUND	We sought to assess the efficacy of a screening strategy for occult cancer that included comprehensive computed tomography ( CT ) of the abdomen and pelvis in patients who had a first unprovoked venous thromboembolism .
-METHODS	We conducted a multicenter , open-label , randomized , controlled trial in Canada .
-METHODS	Patients were randomly assigned to undergo limited occult-cancer screening ( basic blood testing , chest radiography , and screening for breast , cervical , and prostate cancer ) or limited occult-cancer screening in combination with CT. .
-METHODS	The primary outcome measure was confirmed cancer that was missed by the screening strategy and detected by the end of the 1-year follow-up period .
-RESULTS	Of the 854 patients who underwent randomization , 33 ( 3.9 % ) had a new diagnosis of occult cancer between randomization and the 1-year follow-up : 14 of the 431 patients ( 3.2 % ) in the limited-screening group and 19 of the 423 patients ( 4.5 % ) in the limited-screening-plus-CT group ( P = 0.28 ) .
-RESULTS	In the primary outcome analysis , 4 occult cancers ( 29 % ) were missed by the limited screening strategy , whereas 5 ( 26 % ) were missed by the strategy of limited screening plus CT ( P = 1.0 ) .
-RESULTS	There was no significant difference between the two study groups in the mean time to a cancer diagnosis ( 4.2 months in the limited-screening group and 4.0 months in the limited-screening-plus-CT group , P = 0.88 ) or in cancer-related mortality ( 1.4 % and 0.9 % , P = 0.75 ) .
-CONCLUSIONS	The prevalence of occult cancer was low among patients with a first unprovoked venous thromboembolism .
-CONCLUSIONS	Routine screening with CT of the abdomen and pelvis did not provide a clinically significant benefit .
-CONCLUSIONS	( Funded by the Heart and Stroke Foundation of Canada ; SOME ClinicalTrials.gov number , NCT00773448 . )
-
-###25634905
-BACKGROUND	Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing .
-BACKGROUND	We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer ( Orsiro , O-SES ) compared with the durable polymer Xience Prime everolimus-eluting stent ( X-EES ) in terms of the primary end point in-stent late lumen loss at 9 months .
-RESULTS	A total of 452 patients were randomly assigned 2:1 to treatment with O-SES ( 298 patients , 332 lesions ) or X-EES ( 154 patients , 173 lesions ) in a multicenter , noninferiority trial .
-RESULTS	The primary end point was in-stent late loss at 9 months .
-RESULTS	O-SES was noninferior to X-EES for the primary end point ( 0.100.32 versus 0.110.29 mm ; difference = 0.00063 mm ; 95 % confidence interval , -0.06 to 0.07 ; Pnoninferiority < 0.0001 ) .
-RESULTS	Clinical outcome showed similar rates of target-lesion failure at 1 year ( O-SES 6.5 % versus X-EES 8.0 % ; hazard ratio = 0.82 ; 95 % confidence interval , 0.40-1 .68 ; log-rank test : P = 0.58 ) without cases of stent thrombosis .
-RESULTS	A subgroup of patients ( n = 55 ) underwent serial optical coherence tomography at 9 months , which demonstrated similar neointimal thickness among lesions allocated to O-SES and X-EES ( 0.100.04 mm versus 0.110.04 mm ; -0.01 [ -0.04 , -0.01 ] ; P = 0.37 ) .
-RESULTS	Another subgroup of patients ( n = 56 ) underwent serial intravascular ultrasound at baseline and 9 months indicating a potential difference in neointimal area at follow-up ( O-SES , 0.160.33 mm ( 2 ) versus X-EES , 0.430.56 mm ( 2 ) ; P = 0.04 ) .
-CONCLUSIONS	Compared with durable polymer X-EES , novel biodegradable polymer-based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months .
-CONCLUSIONS	Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01356888 .
-
-###26149000
-OBJECTIVE	To observe the sensitivity of stroke volume variation ( SVV ) for assessing volume change during induction period of general anesthesia .
-METHODS	Patients who underwent orthopaedic surgery under general anesthesia and mechanical ventilation were divided into two groups randomly .
-METHODS	Patients in the group were subjected to progressive central hypovolemia and correction of hypovolemia sequentially ; patients in the Group were exposed to hypervolemia alone .
-METHODS	Each step was implemented after 5 minutes when the hemodynamics was stable .
-METHODS	SVV and cardiac index ( CI ) were recorded , and Pearson 's product-moment correlation was used to analyze correlation between SVV and CI .
-RESULTS	Forty patients were included in this study , 20 cases in each group .
-RESULTS	For group patients , SVV was increased significantly along with blood volume reduction , and changes in CI were negatively correlated with changes in SVV ( r = -0.605 , P < 0.01 ) ; SVV decreased significantly along with correction of blood volume ; changes in CI were negatively correlated with changes in SVV ( r = -0.651 , P < 0.01 ) .
-RESULTS	For group patients , along with blood volume increase , SVV did not change significantly ; changes in CI revealed no significant correlation with changes in SVV ( r = 0.067 , P > 0.05 ) .
-CONCLUSIONS	SVV is a useful indicator for hypovolemia , but not for hypervolemia .
-
-###24844029
-BACKGROUND	In guided tissue regenerative surgery , membrane perforations may serve as a mechanism for the passage of cells and biologic mediators from the periosteum and overlying gingival connective tissue into the periodontal defects .
-BACKGROUND	To test this assumption , this study was designed to evaluate levels of bone morphogenetic protein-2 ( BMP-2 ) in gingival crevicular fluid ( GCF ) during the early stages of healing for sites treated with modified perforated membranes ( MPMs ) as compared with occlusive membranes ( OMs ) .
-METHODS	Fifteen non-smoking patients with severe chronic periodontitis participated in this prospective , randomized and single-blinded clinical trial .
-METHODS	Each patient contributed two interproximal contralateral defects that were randomly assigned to either an experimental modified perforated membrane group ( 15 sites ) or a control occlusive membrane group ( 15 sites ) .
-METHODS	Plaque index , gingival index , probing depth ( PD ) , clinical attachment level ( CAL ) and the relative intrabony depth of the defect ( rIBD ) were measured at baseline and reassessed at three , six and nine months after therapy .
-METHODS	Gingival crevicular fluid samples were collected on day 1 and 3 , 7 , 14 , 21 , and 30 days after therapy .
-RESULTS	The MPM-treated group showed a statistically significant improvement in PD reduction and clinical attachment gain compared to the OM control group .
-RESULTS	Similarly , rIBD was significantly reduced in MPM-treated sites as compared with those of the OM group .
-RESULTS	BMP-2 concentrations peaked in the MPM samples obtained during the early postoperative period ( days 1 , 3 and 7 ) with a statistically significant difference compared with OM-treated groups .
-RESULTS	BMP-2 levels decreased sharply in the samples obtained at days 14 , 21 and 30 with non-significant higher levels in MPM samples as compared with those of OM sites .
-CONCLUSIONS	Within the limits of the present study , one can conclude that MPM coverage of periodontal defects is associated with a significant initial increase in GCF levels of BMP-2 , a factor that could improve the clinical outcomes of guided tissue regenerative surgery .
-
-###25404229
-OBJECTIVE	The protective effects of volatile anaesthetics against ischaemia-reperfusion injury have been shown in vitro , but clinical studies have yielded variable results .
-OBJECTIVE	We hypothesized that , in children , sevoflurane provides superior cardioprotection after cardiac surgery on cardiopulmonary bypass ( CPB ) compared with totally intravenous anaesthesia ( TIVA ) .
-METHODS	In this randomized controlled , single-centre study , 60 children with cyanotic and acyanotic heart defects undergoing elective cardiac surgery under CPB ( RACHS-1 1-3 ) were randomized to sevoflurane or TIVA ( midazolam < 6 months of age , propofol > 6 months of age ) .
-METHODS	The primary end-point was the postoperative peak cardiac troponin I/T ( cTnI/T ) .
-METHODS	Perioperative cardiac function ( as determined by brain-type natriuretic peptide , echocardiography and postoperative vasopressor/inotrope requirements ) , short-term clinical outcomes ( duration of intubation , intensive care unit and hospital length of stay ) , postoperative inflammatory profile , and pulmonary , renal and liver function were defined as secondary end-points .
-METHODS	Analysis of variance was used for statistical analysis .
-RESULTS	There was no statistically significant difference in postoperative peak troponin values or any of the secondary end-points .
-RESULTS	In the subgroup of acyanotic patients under 6 months , sevoflurane led to significantly lower postoperative troponin levels compared with midazolam [ reduction of 54 % ( 95 % confidence interval 29-71 % , P = 0.002 ) ] , without any differences in secondary outcome parameters .
-CONCLUSIONS	Sevoflurane did not provide superior myocardial protection in our general paediatric cardiac surgical population .
-CONCLUSIONS	In children under 6 months , however , sevoflurane might be beneficial in comparison with midazolam .
-CONCLUSIONS	The conditioning effects of sevoflurane in specific paediatric subgroups need to be further investigated .
-
-###25181763
-OBJECTIVE	To evaluate the efficacy of a Social Cognitive Theory-based Internet intervention designed to promote and maintain leisure-time physical activity in university-aged female students in Thailand .
-METHODS	The 3-month intervention was delivered through a website and e-mails with a follow-up evaluation 3 months after the end of the intervention .
-METHODS	Female students ( N = 220 ) were allocated to 4 parallel groups .
-RESULTS	Significant increases in steps / day , weekly leisure-time activity score , self-efficacy , outcome expectations , and self-regulation , and reduced resting heart rate were observed at the end of the intervention .
-RESULTS	With the exception of resting heart rate , the intervention effects on these variables also remained at the follow-up .
-CONCLUSIONS	The Internet intervention program was effective in promoting and maintaining leisure-time physical activity in university-aged female students .
-
-###24758776
-BACKGROUND	It remains unclear whether analgesia from intraperitoneal local anesthetics is via local or central mechanisms .
-BACKGROUND	This double-blind clinical trial tests the hypothesis that intraperitoneal local anesthetic is superior to continuous IV infusion for pain management .
-BACKGROUND	Primary outcome was morphine consumption during 0 to 24 h.
-METHODS	Informed consent was obtained from 60 patients , age 30 to 75 yr , American Society of Anesthesiologists physical status I to II , undergoing abdominal hysterectomy .
-METHODS	A computer-generated program randomized patients in parallel arms to group IV : continuous infusion of lidocaine 50 mg/h ( 10 ml ) IV and saline 10 ml/h intermittently intraperitoneal ; group IP : injection of lidocaine 50 mg/h ( 10 ml ) once every hour intraperitoneally and continuous infusion of saline 10 ml/h intravenously ; and group P ( placebo ) : saline 10 ml/h both intravenously and intermittent intraperitoneal injection .
-METHODS	Postoperative morphine consumption , pain intensity , recovery , home discharge , and lidocaine concentrations were measured .
-RESULTS	Morphine consumption during 0 to 24 h was lower in group IP versus group IV , mean difference -22.6 mg ( 95 % CI , 11.4 to 33.8 ; P < 0.01 ) .
-RESULTS	No difference was seen between group IV and group P.
-RESULTS	The total mean plasma concentration of lidocaine in group IP was significantly lower than group IV , 0 to 4.5 h postoperatively ( P = 0.03 ) with no evidence of systemic toxicity .
-RESULTS	Pain intensity and other recovery parameters were similar between the groups .
-CONCLUSIONS	The lower supplemental morphine consumption and plasma lidocaine concentration in group IP would confirm that the effects of local anesthetics are likely to be predominant via local intraperitoneal receptors or anti-inflammatory effects and not via central mechanisms alone .
-
-###24796046
-OBJECTIVE	To explore the effects of warm needling combined with Zhangmo decoction ( see text ) on endometrial receptivity in patients with clomiphene ( CC ) - induced ovulation .
-METHODS	One hundred and sixty cases were randomly divided into a CC group ( group A ) , a CC + progynova group ( group B ) , a CC + Zhangmo decoction group ( group C ) and a CC + Zhangmo decoction + warm needling group ( group D ) , 40 cases in each one .
-METHODS	In the Group A , CC alone was applied .
-METHODS	In the group B , progynova was jointly used on the 8th day of menstrual cycle .
-METHODS	In the Group C , Zhangmo decoction was jointly used on the 5th day of menstrual cycle .
-METHODS	In the group D , based on treatment of the Zhangmo decoction , warm needling was applied at Guanyuan ( CV 4 ) , Zhongji ( CV 3 ) and Zigong ( EX-CA 1 ) etc. .
-METHODS	The endometrial thickness and type , pulsatility index ( PI ) , resistance index ( RI ) , ratio of S/D on day of human chorionic gonadotropin ( HCG ) and pregnancy rate were observed in fou groups .
-RESULTS	The PI , RI and S/D in the group C and D were obviously lower than those in group A and B ( all P < 0.01 ) .
-RESULTS	The endometrial thickness was ( 7.7 + / - 1.49 ) mm in group B , ( 8.2 + / - 1.54 ) mm in group C and ( 8.9 + / - 1.51 ) mm in group D , which were significantly different from ( 6.4 5 + / - 1.26 ) mm in the group A ( all P < 0.01 ) also there was a significant difference between group C and D ( P < 0.05 ) .
-RESULTS	The rate of endometrial type A was 65.0 % in the group D , which was significantly higer than 27.5 % in the group A , 32.5 % in the group B and 35.0 % in the group C ( all P < 0.01 ) .
-RESULTS	The pregnancy rate was 30.0 % in the group D , which was obviously higher than 12.5 % in the group A , 15.0 % in the group B and 17.5 % in the group C ( P < 0.05 ) .
-RESULTS	The endometrial thickness and rate of endometrial type A in the pregnant were obviously higher than those in the non-pregnant ( both P < 0.01 ) while PI , RI and S/D was lower than those in the non-pregnant ( P < 0.01 , P < 0.05 ) .
-CONCLUSIONS	Warm needing combined with Zhangmo decoction could improve endometrial thickness , morphology and uterine spiral artery to improve pregnancy rate , which has superior effect to clomiphene , clomiphene combined with progynova and clomiphene combined with Zhangmo decoction .
-
-###24891081
-OBJECTIVE	Despite their high prevalence in daily life , repeated night-wakings and their cognitive and emotional consequences have received less research attention compared to other types of sleep disturbances .
-OBJECTIVE	Our aim was to experimentally compare the effects of one night of induced infrequent night-wakings ( of 15 min , each requiring a purposeful response ) and sleep restriction on sustained attention and mood in young adults .
-METHODS	In a within-between subjects counterbalanced design , 61 healthy adults ( 40 females ; aged 20-29 years ) underwent home assessments of sustained attention and self-reported mood at two times : after a normal ( control ) sleep night , and after a night of either sleep restriction ( 4h in bed ) or induced night-wakings ( four prolonged awakenings across 8h in bed ) .
-METHODS	Sleep was monitored using actigraphy and sleep diaries .
-METHODS	Sustained attention was assessed using an online continuous performance test ( OCPT ) , and mood was reported online using the Profile of Mood States ( POMS ) .
-RESULTS	Actigraphic data revealed good compliance with experimental sleep requirements .
-RESULTS	Induced night-wakings and sleep restriction both resulted in more OCPT omission and commission errors , and in increased depression , fatigue and confusion levels and reduced vigor compared to the normal sleep night .
-RESULTS	Moreover , there were no significant differences between the consequences of induced awakenings and sleep restriction .
-CONCLUSIONS	Our pilot study indicates that , similar to sleep restriction , one night of life-like repeated night-wakings negatively affects mood and sustained attention .
-
-###24693945
-BACKGROUND	Low back pain affects approximately 80 % of people at some stage in their lives .
-BACKGROUND	Exercise therapy is the most widely used nonsurgical intervention for low back pain in practice guidelines .
-BACKGROUND	Whole body vibration exercise is becoming increasingly popular for relieving musculoskeletal pain and improving health-related quality of life .
-BACKGROUND	However , the efficacy of whole body vibration exercise for low back pain is not without dispute .
-BACKGROUND	This study aims to estimate the effect of whole body vibration exercise for chronic low back pain .
-METHODS	We will conduct a prospective , single-blind , randomized controlled trial of 120 patients with chronic low back pain .
-METHODS	Patients will be randomly assigned into an intervention group and a control group .
-METHODS	The intervention group will participate in whole body vibration exercise twice a week for 3 months .
-METHODS	The control group will receive general exercise twice a week for 3 months .
-METHODS	Primary outcome measures will be the visual analog scale for pain , the Oswestry Disability Index and adverse events .
-METHODS	The secondary outcome measures will include muscle strength and endurance of spine , trunk proprioception , transversus abdominis activation capacity , and quality of life .
-METHODS	We will conduct intention-to-treat analysis if any participants withdraw from the trial .
-CONCLUSIONS	Important features of this study include the randomization procedures , single-blind , large sample size , and a standardized protocol for whole body vibration in chronic low back pain .
-CONCLUSIONS	This study aims to determine whether whole body vibration exercise produces more beneficial effects than general exercise for chronic low back pain .
-CONCLUSIONS	Therefore , our results will be useful for patients with chronic low back pain as well as for medical staff and health-care decision makers .
-BACKGROUND	Chinese Clinical Trial Registry : ChiCTR-TRC-13003708 .
-
-###24699237
-OBJECTIVE	To examine the efficacy of a physical activity behavioral intervention for improving outcomes of body composition in persons with multiple sclerosis ( MS ) .
-METHODS	Secondary analysis of data from a randomized controlled trial .
-METHODS	University research laboratory .
-METHODS	Ambulatory persons with MS ( N = 82 ) .
-METHODS	A 6-month , internet-delivered physical activity behavioral intervention designed to increase lifestyle physical activity , primarily walking .
-METHODS	The behavioral intervention was based on principles of social cognitive theory .
-METHODS	Whole-body bone mineral content ( BMC ) , bone mineral density ( BMD ) , and soft tissue composition , using dual-energy x-ray absorptiometry .
-RESULTS	There were no significant differences between conditions posttrial on body composition outcomes using the adjusted critical value ( P < .008 ) .
-RESULTS	There was a significant effect of the intervention on whole-body BMC ( P = .04 , ( 2 ) < .001 ) and BMD ( P = .01 , ( 2 ) = .003 ) using the unadjusted critical value ( P < .05 ) .
-RESULTS	The effect of the intervention on percent body fat ( P = .09 , ( 2 ) = .001 ) and whole-body fat mass ( P = .05 , ( 2 ) = .003 ) approached significance using unadjusted criteria .
-RESULTS	There was not a significant effect on whole-body lean soft tissue ( P = .28 , ( 2 ) < .001 ) or body mass index ( P = .86 , ( 2 ) < .001 ) .
-CONCLUSIONS	Our results provide preliminary evidence that an internet-delivered lifestyle physical activity intervention might improve bone health and body composition in MS. Such findings are important considering that physical activity is a modifiable behavior with the potential to confer long-term benefits for the prevention and management of fracture risk and comorbidities among those with MS.
-
-###25127887
-BACKGROUND	After kidney transplantation , immunosuppressive therapy causes impaired cellular immune defense leading to an increased risk of viral complications .
-BACKGROUND	Trough level monitoring of immunosuppressants is insufficient to estimate the individual intensity of immunosuppression .
-BACKGROUND	We have already shown that virus-specific T cells ( Tvis ) correlate with control of virus replication as well as with the intensity of immunosuppression .
-BACKGROUND	The multicentre IVIST01-trial should prove that additional steering of immunosuppressive and antiviral therapy by Tvis levels leads to better graft function by avoidance of over-immunosuppression ( for example , viral infections ) and drug toxicity ( for example , nephrotoxicity ) .
-METHODS	The IVIST-trial starts 4weeks after transplantation .
-METHODS	Sixty-four pediatric kidney recipients are randomized either to a non-intervention group that is only treated conservatively or to an intervention group with additional monitoring by Tvis .
-METHODS	The randomization is stratified by centre and cytomegalovirus ( CMV ) prophylaxis .
-METHODS	In both groups the immunosuppressive medication ( cyclosporine A and everolimus ) is adopted in the same target range of trough levels .
-METHODS	In the non-intervention group the immunosuppressive therapy ( cyclosporine A and everolimus ) is only steered by classical trough level monitoring and the antiviral therapy of a CMV infection is performed according to a standard protocol .
-METHODS	In contrast , in the intervention group the dose of immunosuppressants is individually adopted according to Tvis levels as a direct measure of the intensity of immunosuppression in addition to classical trough level monitoring .
-METHODS	In case of CMV infection or reactivation the antiviral management is based on the individual CMV-specific immune defense assessed by the CMV-Tvis level .
-METHODS	Primary endpoint of the study is the glomerular filtration rate 2years after transplantation ; secondary endpoints are the number and severity of viral infections and the incidence of side effects of immunosuppressive and antiviral drugs .
-CONCLUSIONS	This IVIST01-trial will answer the question whether the new concept of steering immunosuppressive and antiviral therapy by Tvis levels leads to better future graft function .
-CONCLUSIONS	In terms of an effect-related drug monitoring , the study design aims to realize a personalization of immunosuppressive and antiviral management after transplantation .
-CONCLUSIONS	Based on the IVIST01-trial , immunomonitoring by Tvis might be incorporated into routine care after kidney transplantation .
-BACKGROUND	EudraCT No : 2009-012436-32 , ISRCTN89806912 ( 17 June 2009 ) .
-
-###24238770
-BACKGROUND	Breathing-retraining and helium-oxygen ( heliox ) have been used to improve exercise tolerance in COPD .
-BACKGROUND	We hypothesized that , in patients with COPD , exercise duration after exercise-training plus breathing-retraining and oxygen would be longer than after exercise-training plus heliox or after exercise-training plus oxygen alone .
-BACKGROUND	We also explored the short-term maintenance of gains in exercise duration after using each technique .
-METHODS	Of 192 COPD patients recruited , 103 were randomly assigned to exercise-training plus heliox ( n = 33 ) , exercise-training plus breathing-retraining and oxygen ( n = 35 ) and exercise-training and oxygen ( n = 35 ) .
-METHODS	FiO2 was 0.30 during testing and training in all groups .
-METHODS	Patients exercised on a treadmill thrice-weekly for eight weeks .
-METHODS	Before , at completion of training , and six-weeks later , patients underwent constant-load treadmill testing .
-RESULTS	At completion of training , improvements in exercise duration in the heliox and breathing-retraining groups were not significantly different .
-RESULTS	Compared to the exercise-training plus oxygen group , exercise duration improved more in the breathing-retraining group ( P = 0.008 ) but not in the heliox group ( P = 0.142 ) .
-RESULTS	Hyperinflation was reduced with breathing-retraining plus oxygen compared to the other two groups .
-RESULTS	Six-weeks later , improvements in exercise duration were still greater with breathing-retraining than with exercise-training ( P = 0.015 ) .
-RESULTS	In contrast , improvements in exercise duration with heliox did not differ from those in the other two groups .
-CONCLUSIONS	In moderate-to-severe COPD , exercise-training combined with either heliox or with breathing-retraining yielded not significantly different improvements in exercise duration - with only the latter being superior to exercise-training .
-CONCLUSIONS	Six-weeks after training , these improvements were still greater after exercise-training plus breathing-retraining than after exercise-training .
-BACKGROUND	ClinicalTrials.gov ; No. : NCT00123422 .
-
-###24887223
-BACKGROUND	The incidence of transfusion-related acute lung injury ( TRALI ) in cardiac surgery patients is high and this condition contributes to an adverse outcome .
-BACKGROUND	Damage-associated molecular pattern ( DAMP ) molecules , HMGB1 and S100A12 , are thought to mediate inflammatory changes in acute respiratory distress syndrome .
-BACKGROUND	We aimed to determine whether DAMP are involved in the pathogenesis of TRALI in cardiac surgery patients .
-METHODS	This was a secondary analysis of a prospective observational trial in cardiac surgery patients admitted to the Intensive Care Unit of a university hospital in the Netherlands .
-METHODS	Fourteen TRALI cases were randomly matched with 32 transfused and non-transfused controls .
-METHODS	Pulmonary levels of HMGB1 , S100A12 and inflammatory cytokines ( interleukins-1 , -6 , and -8 and tumour necrosis factor - ) were determined when TRALI evolved .
-METHODS	In addition , systemic and pulmonary levels of soluble receptor for advanced glycation end products ( sRAGE ) were determined .
-RESULTS	HMGB1 expression and levels of sRAGE in TRALI patients did not differ from those in controls .
-RESULTS	There was a trend towards higher S100A12 levels in TRALI patients compared to the controls .
-RESULTS	Furthermore , S100A12 levels were associated with increased levels of markers of pulmonary inflammation , prolonged cardiopulmonary bypass , hypoxemia and duration of mechanical ventilation .
-CONCLUSIONS	No evidence was found that HMGB1 and sRAGE contribute to the development of TRALI .
-CONCLUSIONS	S100A12 is associated with duration of cardiopulmonary bypass , pulmonary inflammation , hypoxia and prolonged mechanical ventilation and may contribute to acute lung injury in cardiac surgery patients .
-
-###25546165
-OBJECTIVE	The objective of this study was to evaluate the pharmacokinetic parameters of triflusal and its major active metabolite , 2-hydroxy-4-trifluoromethyl benzoic acid ( HTB ) , following a single oral dose of 900 mg in healthy subjects under fed and fasting conditions .
-METHODS	The study participants ( n = 12 ) were randomized to receive one 900 mg triflusal capsule in a fasting condition ( no food for 12 hours ) or a fed condition ( after a high-fat meal ) ; after a 2-week washout period , participants received the same dose of triflusal capsule under the converse condition .
-METHODS	Pharmacokinetic parameters were calculated using WinNonlin 6.2 software .
-METHODS	Safety was evaluated through assessment of adverse events , standard laboratory evaluations , vital signs , and 12-lead electrocardiography .
-RESULTS	The mean Cmax of triflusal and HTB were 13.96 , 110.2 ug/mL for the fasting state and 9.546 , 97.15 ug/mL for the fed state , respectively .
-RESULTS	The AUC0-144 of triflusal and HTB were 19.66 , 5,572 hxg/mL for the fasting state and 22.20 , 5,038 hxg/mL for the fed state , the AUC0 - of triflusal and HTB were 19.79 , 6,333 hxg/mL for the fasting state and 22.44 , 5,632 hxg/mL for the fed state , respectively .
-RESULTS	The results showed that Cmax and AUCs for triflusal were outside the bioequivalency ( BE ) interval after food intake , but there was no statistically significant change for HTB .
-CONCLUSIONS	High-fat food intake may affect the pharmacokinetics of triflusal capsule in healthy subjects .
-
-###25577731
-OBJECTIVE	This research compared the effects of real versus hyper-real images on anxiety , disgust , and physiological arousal during internet-delivered exposure in high spider-fearfuls .
-OBJECTIVE	Hyper-real images were digitally altered to highlight fearful aspects .
-OBJECTIVE	A further aim was to examine self-reported and behavioural therapeutic outcomes and exposure-related predictors of these outcomes .
-METHODS	Twenty-eight females were randomised to real ( n = 14 ) or hyper-real ( n = 14 ) treatment groups and nine participants were subsequently allocated to a wait-list control group .
-METHODS	Treatment groups viewed an 8-stage exposure hierarchy of real or hyper-real spider images .
-METHODS	Subjective anxiety and disgust ratings were taken during each stage ( 0 , 60 , 120 , 180s ) with heart rate and skin conductance recorded throughout .
-RESULTS	Anxiety , disgust and physiological arousal habituated within each exposure stage , with no differential effect of real compared to hyper-real images .
-RESULTS	Both treatment groups but not controls demonstrated significant reductions in behavioural avoidance and self-reported phobic symptoms from pre-treatment to post-treatment with large effect sizes noted .
-RESULTS	The change in within-stage habituation of anxiety , disgust and heart rate , between the first and last stage , predicted improvement in behavioural avoidance at post-treatment .
-RESULTS	This suggests that generalisation of habituation to multiple images is an important predictor of improvement .
-CONCLUSIONS	While findings in relation to therapeutic outcome should be considered preliminary , clear relationships were found between exposure-related variables and outcome among those who undertook treatment .
-CONCLUSIONS	Findings provide evidence in support of the efficacy of online image-based exposure and have implications for informing further research into the underlying mechanisms of image-based exposure treatment .
-
-###24433108
-OBJECTIVE	Recently , obesity patients have been diagnosed as metabolic syndrome .
-OBJECTIVE	The aim of this study was to evaluate which angiotensin type 1 receptor blockers ( ARBs ) , telmisartan or candesartan , is superior for the control of home blood pressure ( BP ) in the morning when the outpatient clinic BP was well controlled in the patients with metabolic syndrome .
-METHODS	The patients with metabolic syndrome were enrolled .
-METHODS	Home BP was monitored by using a telemedicine system .
-METHODS	After a 2 - to 4-week control period to establish baseline home BP values , these patients were randomly divided into telmisartan ( 20-80 mg ) and candesartan ( 4-12 mg ) groups .
-METHODS	These end points were evaluated by using the telemedicine system during steady-state active therapy .
-METHODS	A total of 356 patients attending 60 outpatient Japanese centers were recruited .
-RESULTS	On a day of active therapy , telmisartan significantly lowered both systolic and diastolic home BP in the morning to a greater extent compared to candesartan .
-RESULTS	At the end of the study , reductions in systolic and diastolic home BP in the morning , in telmisartan group were significantly larger compared to the changes in the candesartan group ( systolic ; Tel : 12.0 8.9 versus Can : 8.1 17.1 mmHg , p = 0.0292 , diastolic ; Tel : 7.4 6.1 versus Can : 3.7 6.8 mmHg , p = 0.0053 ) .
-RESULTS	Additionally in the telmisartan treated group , LDL-cholesterol showed significant reduction ( p = 0.037 ) , but candesartan did not .
-CONCLUSIONS	The present study by using the telemedicine system clearly demonstrated that telmisartan has a strong effect on reducing morning home BP , and a good effect on lipid metabolism in patients with metabolic syndrome .
-
-###24495697
-OBJECTIVE	Most men diagnosed with prostate cancer become long-term survivors , but are at risk for medical late-effects that can affect their long-term health .
-OBJECTIVE	Mailed surveys are well suited to study late-effects in this population , but low response rates can compromise survey validity .
-OBJECTIVE	This study investigated whether an unconditional $ 5.00 gift certificate incentive or Priority Mail delivery increased prostate cancer survivors ' response to mailed surveys .
-METHODS	976 participants ( mean age = 66.8 years ) , 2-8 years post-diagnosis , were randomized to one of four groups : Incentive ; Priority Mail ; Incentive & Priority Mail ; or Control .
-METHODS	After an introductory letter , initial study packets were mailed based on randomization ; 46 days later , a second study packet was mailed to all non-responders by First-Class Mail .
-RESULTS	The first mailing yielded a significant variation in response rates across groups ( ( 2 ) = 9.34 ; p = 0.025 ) .
-RESULTS	Priority Mail ( 64.7 % ; p = 0.008 ) and Incentive & Priority Mail ( 63.6 % ; p = 0.016 ) groups had significantly higher response rates than Controls ( 52.9 % ) .
-RESULTS	After the second mailing , the overall response rate increased significantly from 59.6 % to 71.4 % ( p < 0.001 ) ; however , response rates no longer differed across groups ( range , 69.3 % [ Incentive group ] to 73.9 % [ Priority Mail group ] ) .
-CONCLUSIONS	Long-term prostate cancer survivors ' response rates to mailed surveys increased with the use of Priority Mail and a repeat survey mailing , but the unconditional gift certificate incentive was not supported in this population .
-CONCLUSIONS	By identifying and applying specialized survey methods , studies targeting survivors of prostate cancer and other geriatric cancers may improve response rates , thus limiting a source of potential bias .
-
-###24237999
-OBJECTIVE	To assess , in a randomised controlled trial ( RCT ) and in clinical practice , an association of time to remission and baseline disease activity with both induction of remission and sustained remission in etanercept-treated patients with rheumatoid arthritis ( RA ) .
-METHODS	Data from an RCT ( Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes [ TEMPO ] ; n = 682 ) and an observational registry ( Rheumatoid Arthritis DMARD Intervention and Utilization Study [ RADIUS II ] ; n = 4341 ) were used to evaluate disease activity ( Clinical Disease Activity Index [ CDAI ] score ) over time in patients initiating etanercept ( monotherapy or with methotrexate ) .
-METHODS	CDAI remission ( CDAI2 .8 ) and sustained remission ( 6 months ) were determined through year 3 by treatment group , study , time to remission , and disease severity .
-RESULTS	Patients from TEMPO and RADIUS II who received etanercept monotherapy showed similar CDAI remission rates ( 39 % and 35 % , respectively , at 3 years ) .
-RESULTS	Among patients who received etanercept with methotrexate , remission rates were 54 % and 36 % , respectively .
-RESULTS	Remission occurred more rapidly in TEMPO than RADIUS II perhaps from differences in compliance , patient populations , or sequence of combination therapy initiation .
-RESULTS	Generally , more patients with lower baseline CDAI scores achieved remission than those with higher scores .
-RESULTS	Continued remission appeared more likely in patients achieving remission earlier in the course of their therapy ( 0-6 months ) .
-CONCLUSIONS	Remission by year 3 in etanercept-treated ( with and without methotrexate ) patients with RA occurred in 35 % of patients in both an RCT ( TEMPO ) and a clinical practice setting ( RADIUS II ) , and more frequently in those with lower baseline disease severity .
-CONCLUSIONS	Patients with lower RA disease activity were more likely to reach remission .
-CONCLUSIONS	Continued remission may be more likely in patients who achieved remission earlier .
-
-###24816938
-OBJECTIVE	To evaluate the agreement between tumour volume derived from semiautomated volumetry ( SaV ) and tumor volume defined by spherical volume using longest lesion diameter ( LD ) according to Response Evaluation Criteria In Solid Tumors ( RECIST ) or ellipsoid volume using LD and longest orthogonal diameter ( LOD ) according to World Health Organization ( WHO ) criteria .
-METHODS	Twenty patients with metastatic colorectal cancer from the CIOX trial were included .
-METHODS	A total of 151 target lesions were defined by baseline computed tomography and followed until disease progression .
-METHODS	All assessments were performed by a single reader .
-METHODS	A variance component model was used to compare the three volume versions .
-RESULTS	There was a significant difference between the SaV and RECIST-based tumour volumes .
-RESULTS	The same model showed no significant difference between the SaV and WHO-based volumes .
-RESULTS	Scatter plots showed that the RECIST-based volumes overestimate lesion volume .
-RESULTS	The agreement between the SaV and WHO-based relative changes in tumour volume , evaluated by intraclass correlation , showed nearly perfect agreement .
-CONCLUSIONS	Estimating the volume of metastatic lesions using both the LD and LOD ( WHO ) is more accurate than those based on LD only ( RECIST ) , which overestimates lesion volume .
-CONCLUSIONS	The good agreement between the SaV and WHO-based relative changes in tumour volume enables a reasonable approximation of three-dimensional tumour burden .
-CONCLUSIONS	Tumour response in patients undergoing chemotherapy is assessed using CT images Measurements are based on RECIST ( unidimensional ) - based or WHO ( bidimensional ) - based criteria We calculated tumour volume from bidimensional target lesion measurements This formula provides good tumour volume approximation , based on semiautomated volumetry .
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-###25447749
-BACKGROUND	In spatial neglect , the functional benefit of rehabilitation methods is subject to debate .
-BACKGROUND	A few studies have reported that galvanic vestibular stimulation ( GVS ) is efficacious in spatial neglect .
-BACKGROUND	The objective of the present study was to establish whether the effects of GVS persist after the end of stimulation .
-METHODS	Four patients with pathological rightward deviation in a bisection task at least three months after right hemisphere stroke .
-METHODS	A single-blind , randomized crossover design was used to assess the effects of GVS on performance in line bisection and star cancellation tasks under three different conditions ( cathode-right , cathode-left and sham stimulation ) .
-RESULTS	There were no significant differences in the performance of either task following GVS ( relative to sham stimulation ) .
-CONCLUSIONS	Galvanic vestibular stimulation did not reduce spatial neglect symptoms in any of the stimulation conditions .
-CONCLUSIONS	Further studies are necessary to understand the disparity between our results and those reported in the literature .
-CONCLUSIONS	Repeated sessions , a higher current intensity and/or alternating-current stimulation may improve this method before it can be used clinically .
-
-###25335328
-OBJECTIVE	To evaluate the efficacy and safety of using Jiangzhi Tongluo Soft Capsule ( JTSC ) combined with Atorvastatin Calcium Tablet ( ACT ) or ACT alone in treatment of combined hyperlipidemia .
-METHODS	A randomized , double blinded , parallel control , and multi-center clinical research design was adopted .
-METHODS	Totally 138 combined hyperlipidemia patients were randomly assigned to the combined treatment group ( A ) and the atorvastatin treatment group ( B ) by random digit table , 69 in each group .
-METHODS	All patients took ACT 20 mg per day .
-METHODS	Patients in the A group took JTSC 100 mg each time , 3 times per day .
-METHODS	Those in the B group took JTSC simulated agent , 100 mg each time , 3 times per day .
-METHODS	The treatment period for all was 8 weeks .
-METHODS	Serum levels of triglyceride ( TG ) , total cholesterol ( TC ) , low density lipoprotein cholesterol ( LDL-C ) , and high density lipoprotein cholesterol ( HDL-C ) were observed before treatment , at week 4 and 8 after treatment ; and safety was assessed as well .
-RESULTS	At week 4 and 8 after treatment serum TG decreased by 26.69 % and 33.29 % respectively in the A group ( both P < 0.01 ) , while it was decreased by 25.7 % and 22.98 % respectively in the B group ( both P < 0.01 ) .
-RESULTS	At week 8 decreased serum TG was obviously higher in the A group than in the B group ( P < 0.05 ) .
-RESULTS	Compared with before treatment , serum levels of LDL-C and TC levels decreased significantly in the two groups ( all P < 0.01 ) .
-RESULTS	There was no statistical difference in the drop-out value and the drop-out rate of serum LDL-C and TC levels ( P > 0.05 ) .
-RESULTS	At week 8 the serum HDL-C level showed an increasing tendency in the two groups .
-RESULTS	No obvious increase in peptase or creatase occurred in the two groups after treatment .
-CONCLUSIONS	JTSC combined with ACT could lower the serum TG level of combined hyperlipidemia patients with safety .
-
-###25346499
-BACKGROUND	Patients with atrial fibrillation ( AF ) in the acute stage of ischemic stroke or transient ischemic attack ( TIA ) are at high risk of recurrent stroke , but the optimal anticoagulation strategy remains unclear due to the concern of intracranial bleeding .
-BACKGROUND	Novel oral anticoagulants compared to warfarin might be more safe and efficacious in patients suitable for early anticoagulation .
-OBJECTIVE	This trial is to evaluate the feasibility of early anticoagulation with rivaroxaban in acute ischemic stroke or TIA patients with nonvalvular AF .
-METHODS	This is a randomized , open-label , blinded endpoint evaluation trial .
-METHODS	Inclusion criteria are ( 1 ) nonvalvular AF , ( 2 ) presumed cardioembolic stroke or transient ischemic attack ( TIA ) confirmed by MRI within five-days from onset , and ( 3 ) mild to moderate stroke severity .
-METHODS	We will randomize 196 patients to either rivaroxaban ( 10mg once daily for five-days followed by 15mg or 20mg once daily ) or dose-adjusted warfarin ( coadministration of aspirin 100mg per day until achieving international normalized ratio of 17 ) .
-METHODS	The study is registered in ClinicalTrials.gov ( NCT02042534 ) .
-RESULTS	The primary endpoint is the composite of recurrent ischemic lesion and intracranial bleeding on MRI at four-weeks .
-RESULTS	Secondary endpoints are recurrent ischemic lesions , intracranial bleeding , major bleeding , major vascular events , four-week modified Rankin Scale score , and duration of hospitalization after randomization .
-CONCLUSIONS	The results of this proof-of-concept trial will guide go/no-go decision to a large phase 3 confirmatory trial .
-
-###24530600
-OBJECTIVE	ASP9831 is a phosphodiesterase-4 inhibitor developed to treat nonalcoholic steatohepatitis ( NASH ) ; it showed potent anti-inflammatory and antifibrotic effects in preclinical studies .
-OBJECTIVE	We evaluated the efficacy and safety of ASP9831 in patients with NASH .
-METHODS	In a phase 1 trial , we determined the optimal therapeutic window of ASP9831 in healthy volunteers and evaluated 2 doses ( 50 and 100 mg ) in patients with NASH .
-METHODS	Based on the positive outcomes of the phase 1 study , we performed a phase 2 trial to compare the biochemical effects of ASP9831 vs placebo .
-METHODS	Patients with NASH were assigned randomly to groups given either 50 mg ( n = 33 ) or 100 mg ( n = 33 ) ASP9831 twice daily , or placebo ( n = 30 ) , for 12 weeks .
-METHODS	The primary end point was the mean percentage change , from baseline to the end of ASP9831 administration , in serum level of alanine aminotransferase ( ALT ) ; secondary outcomes included changes in aspartate aminotransferase ( AST ) levels , ratio of AST : ALT , and various biomarkers of NASH .
-RESULTS	After 12 weeks of administration , there was no significant change in mean serum levels of ALT ( P = .42 ) or AST ( P = .20 ) or other biomarkers in any group , and no significant differences were observed among groups .
-RESULTS	Most adverse events were mild ; gastrointestinal disorders occurred more frequently in the ASP9831 groups than the placebo group .
-CONCLUSIONS	Despite a relevant mechanism of action , ASP9831 did not significantly alter the biochemical markers of NASH , compared with placebo , in a clinical trial .
-CONCLUSIONS	This highlights the difficulties of developing therapeutics for NASH and the need for more extensive preclinical testing of mechanisms of potential drug candidates .
-CONCLUSIONS	Clinicaltrialsregister.eu : 2005-001687-31 ; EudraCT numbers : 2007-002114-19 .
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-###25214451
-OBJECTIVE	This randomized controlled trial compare the efficacy of pelvic floor muscle training vs. transcutaneous posterior tibial nerve stimulation .
-METHODS	Inclusion criteria were EDSS score < 7 and presence of lower urinary tract symptoms .
-METHODS	Exclusion criteria were multiple sclerosis relapse during the study , active urinary tract infection and pregnancy .
-METHODS	The primary outcome was quality of life ( SF-Qualiveen questionnaire ) .
-METHODS	Secondary outcomes included overactive bladder ( USP questionnaire ) score and frequency of urgency episodes ( 3-day bladder diary ) .
-METHODS	Sample size was calculated after 18 patients were included .
-METHODS	Data analysis was blinded .
-METHODS	Each patient received 9 sessions of 30 minutes weekly .
-METHODS	Patients were randomized in pelvic floor muscles exercises with biofeedback group ( muscle endurance and relaxation ) or transcutaneous posterior tibial nerve stimulation group ( rectangular alternative biphasic current with low frequency ) .
-RESULTS	A total of 31 patients were included .
-RESULTS	No difference appeared between groups for quality of life , overactive bladder and frequency of urgency episodes ( respectively P = 0.197 , P = 0.532 et P = 0.788 ) .
-RESULTS	These parameters were significantly improved in pelvic floor muscle training group ( n = 16 ) ( respectively P = 0.004 , P = 0.002 et P = 0.006 ) and in transcutaneous posterior tibial nerve stimulation group ( n = 15 ) ( respectively P = 0.001 , P = 0.001 et P = 0.031 ) .
-CONCLUSIONS	Pelvic floor muscle training and transcutaneous posterior tibial nerve stimulation improved in the same way symptoms related to urgency in MS patients with mild disability .
-METHODS	2 .
-
-###26016861
-BACKGROUND	Dietary lipids are one of the most effective stimulators of carotenoid absorption , but very limited data exist on the impact of endogenous food sources of lipids to enhance carotenoid absorption .
-BACKGROUND	The co-consumption of whole egg with carotenoid-rich foods may increase overall carotenoid absorption via lipid-rich egg yolk .
-OBJECTIVE	We designed this study to assess the effects of egg consumption on carotenoid absorption from a carotenoid-rich , raw mixed-vegetable salad .
-METHODS	Healthy young men ( n = 16 ) consumed the same salad ( all served with 3 g canola oil ) with no egg ( control ) , 75 g scrambled whole eggs ( 1.5 eggs ) [ low egg ( LE ) ] , and 150 g scrambled whole eggs ( 3 eggs ) [ high egg ( HE ) ] ( a randomized crossover design ) .
-METHODS	Control , LE , and HE meals contained 23 mg , 23.4 mg ( 0.4 mg from eggs ) , and 23.8 mg ( 0.8 mg from eggs ) total carotenoids and 3 g , 10.5 g ( 7.5 g from eggs ) , and 18 g ( 15 g from eggs ) total lipids , respectively .
-METHODS	Blood was collected hourly for 10 h , and the triacylglycerol-rich lipoprotein ( TRL ) fraction was isolated .
-METHODS	Total and individual carotenoid contents , including lutein , zeaxanthin , - carotene , - carotene , and lycopene in TRL were analyzed , and composite areas under the curve ( AUCs ) were calculated .
-RESULTS	The total mean ( SE ) carotenoid AUC0-10h in TRL was higher for the HE meal than for LE and control meals [ 125.7 19.4 ( a ) compared with 44.8 9.2 ( b ) compared with 14.9 5.2 ( b ) nmol/L 10 h , respectively ( values without a common superscript letter differ ) ; P < 0.0001 ] .
-RESULTS	The TRL AUC ( 0-10h ) of lutein and zeaxanthin increased 4-5-fold ( P < 0.001 ) , and the TRL AUC ( 0-10h ) of carotenoid not present in eggs , including - carotene , - carotene , and lycopene , increased 3-8-fold ( P < 0.01 ) for the HE meal compared with the control meal .
-CONCLUSIONS	These findings support the claim that co-consuming cooked whole eggs is an effective way to enhance carotenoid absorption from other carotenoid-rich foods such as a raw mixed-vegetable salad .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01951313 .
-
-###24449626
-OBJECTIVE	The aim of the present study was to assess access site pain levels of patients undergoing coronary catheterization via transradial route .
-METHODS	We performed a prospective and randomized study in which 408 patients underwent coronary angiography ( CAG ) and/or percutaneous coronary intervention ( PCI ) via transradial approach ( TRA ) and 428 patients underwent CAG and/or PCI via transfemoral approach ( TFA ) .
-METHODS	Pain levels of patients were assessed with Visual Analog Scale ( VAS ) after catheterization and at 30 days .
-METHODS	Student-t , Mann-Whitney U and chi-square tests were used for statistical analysis .
-RESULTS	Patients in the TRA group showed higher VAS scores than those in TFA group after catheterization [ CAG alone , 3 ( 2-5 ) vs. 1 ( 1-3 ) , p < 0.0001 ; PCI , 4 ( 2-6 ) vs. 2 ( 1-3 ) , p < 0.0001 , respectively ] .
-RESULTS	One month later , patients in TRA group also showed higher VAS scores than those in TFA group [ CAG alone , 1 ( 0-1 ) vs. 0 ( 0-1 ) , p < 0.0001 ; PCI , 1 ( 0-2 ) vs. 0 ( 0-1 ) , p < 0.0001 , respectively ] .
-RESULTS	By the ROC analysis in TRA group , a level of BMI < 24.3 kg/m2 predicted unacceptable pain with a 87.3 % sensitivity and 91.6 % specificity [ area under curve ( AUC ) : 0.875 , 95 % CI : 0.839-0 .906 , p < 0.0001 ] , while a wrist circumference < 16.7 cm predicted unacceptable pain with 84.6 % sensitivity and 89.8 % specificity ( AUC : 0.900 , 95 % CI : 0.867-0 .928 , p < 0.0001 ) .
-CONCLUSIONS	The current study suggests that a radial approach for CAG and PCI in patients with a low BMI and small wrist circumference may cause more access site pain as compared with a femoral approach .
-
-###26173731
-OBJECTIVE	Post-hoc , we hypothesized that over the recruitment period of the Carotid Revascularization Endarterectomy Versus Stenting Trial ( CREST ) , increasing experience and improved patient selection with carotid stenting , and to a lesser extent , carotid endarterectomy would contribute to lower periprocedural event rates .
-METHODS	Three study periods with approximately the same number of patients were defined to span recruitment .
-METHODS	Composite and individual rates of periprocedural stroke , myocardial infarction , and death rate were calculated separately by treatment assignment ( carotid stenting/carotid endarterectomy ) .
-METHODS	Temporal changes in unadjusted event rates , and rates after adjustment for temporal changes in patient characteristics , were assessed .
-RESULTS	For patients randomized to carotid stenting , there was no significant temporal change in the unadjusted composite rates that declined from 6.2 % in the first period , to 4.9 % in the second , and 4.6 % in the third ( P = 0.28 ) .
-RESULTS	Adjustment for patient characteristics attenuated the rates to 6.0 % , 5.9 % , and 5.6 % ( P = 0.85 ) .
-RESULTS	For carotid endarterectomy-randomized patients , both the composite and the combined stroke and death outcome decreased between periods 1 and 2 and then increased in period 3 .
-CONCLUSIONS	The hypothesized temporal reduction of stroke + death events for carotid stenting-treated patients was not observed .
-CONCLUSIONS	Further adjustment for changes in patient characteristics between periods , including the addition of asymptomatic patients and a > 50 % decrease in proportion of octogenarians enrolled , resulted in practically identical rates .
-BACKGROUND	URL : http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00004732 .
-
-###24491073
-OBJECTIVE	Evidence linking extreme response style ( ER ) to depressive relapse has been mixed .
-OBJECTIVE	One reason might be high levels of extreme responses that are positive in nature ( ER-Ps ) compared with those negative in nature ( ER-Ns ) at posttreatment .
-OBJECTIVE	ER-Ps likely consist of both maladaptive `` style '' responses and adaptive `` content '' responses ( i.e. , legitimate denials of dysfunction ) .
-OBJECTIVE	The composition of ER-Ps might confound measures of total extreme responding as well as conventional scores on cognitive questionnaires .
-OBJECTIVE	In the current study , we assessed ER in a new sample by ( a ) disambiguating ER-Ps that reflect style from those that reflect content and ( b ) assessing the contribution of ER-Ps to the prediction of relapse/recurrence .
-METHODS	Responders ( N = 104 ) to a randomized controlled trial of cognitive therapy versus medications for moderate to severe depression had an average age of 40 years ( SD = 12 ) , and they were 58 % female , 38 % married/cohabitating , and 85 % Caucasian .
-METHODS	ER variables were calculated using the Dysfunctional Attitudes Scale ( DAS ; Weissman , 1979 ) , with ER-Ps categorized as either content or style responses .
-METHODS	ER indices and DAS scores were used to predict symptom return over 2 years .
-RESULTS	No standard extreme responding variables ( e.g. , an index of total extreme responding ) predicted symptom return , but higher relative levels of style ER-P predicted relapse/recurrence .
-RESULTS	Total DAS scores also predicted relapse/recurrence but only when high levels of style ER-P responses were controlled .
-CONCLUSIONS	ER-Ps , at least on the DAS , appear to contain indicators of both adaptive and maladaptive positive responses .
-CONCLUSIONS	Future research should attend to the valence of the extreme responses as well as to the content of extreme positive responses , which may reflect either healthy or unhealthy tendencies .
-
-###25830503
-BACKGROUND	Recent evidence supports the efficacy of programs that promote improvements in the health practices of workers 50 years and older who are at higher risk for chronic diseases than younger workers are .
-BACKGROUND	Internet-based programs that promote healthy practices have also shown promise and , therefore , should be especially appropriate for workers aged 50 years and older .
-OBJECTIVE	The purpose of the research was to evaluate the effectiveness of HealthyPast50 , a fully automated Web-based health promotion program based on social cognitive theory and aimed specifically at workers 50 years and older .
-METHODS	The randomized controlled trial was conducted across multiple US offices of a large global information technology company .
-METHODS	The sample included 278 employees aged 50 to 68 who were recruited online and randomly assigned to the Web-based HealthyPast50 program or to a wait-list control condition .
-METHODS	Self-report measures of diet , physical activity , stress , and tobacco use were collected online before and 3 months after the program group was given access to the program .
-METHODS	Use data included number of log-ins and number of pages accessed .
-METHODS	The primary analysis was multiple linear regression , following intent-to-treat principles with multiple imputation using the Markov chain Monte Carlo ( MCMC ) approach for nonmonotone missing data .
-METHODS	Potential moderators from demographic characteristics and program dosage effects were assessed using multiple linear regression models .
-METHODS	Additional analyses were conducted on complete ( nonimputed ) cases , excluding program participants who used the program for less than 30 minutes .
-RESULTS	Retention rates were good for both groups : 80.4 % ( 111/138 ) for the program group and 94.3 % ( 132/140 ) for the control group .
-RESULTS	Program group participants spent a mean of 102.26 minutes in the program ( SD 148.32 ) , logged in a mean of 4.33 times ( SD 4.28 ) , and viewed a mean of 11.04 pages ( SD 20.08 ) .
-RESULTS	In the analysis of the imputed dataset , the program group performed significantly better than the control group on diet behavioral change self-efficacy ( estimated adjusted difference [ ] = 0.16 , P = .048 ) , planning healthy eating ( = 0.17 , P = .03 ) , and mild exercise ( = 1.03 , P = .01 ) .
-RESULTS	Moderator and dosage analyses of the dataset found no significant program effects .
-RESULTS	Analyses of the nonimputed dataset comparing program users with controls found additional significant program effects on eating practices ( = 0.09 , P = .03 ) , exercise self-efficacy ( = 0.12 , P = .03 ) , exercise planning ( = 0.18 , P = .03 ) , and aging beliefs ( = 0.17 , P = .01 ) .
-RESULTS	Moderator analysis of this dataset also found significant moderator effects of gender on multiple measures of exercise .
-CONCLUSIONS	A Web-based health promotion program showed promise for making a significant contribution to the short-term dietary and exercise practices of older working adults .
-CONCLUSIONS	Gender effects suggest that the program effects on exercise are due mainly to improvements among women .
-
-###24574227
-OBJECTIVE	To evaluate the presence of spinal inflammation with and without sacroiliac ( SI ) joint inflammation on magnetic resonance imaging ( MRI ) in patients with active nonradiographic axial spondyloarthritis ( SpA ) , and to compare the disease characteristics of these subgroups .
-METHODS	ABILITY-1 is a multicenter , randomized , controlled trial of adalimumab versus placebo in patients with nonradiographic axial SpA classified using the Assessment of SpondyloArthritis international Society axial SpA criteria .
-METHODS	Baseline MRIs were centrally scored independently by 2 readers using the Spondyloarthritis Research Consortium of Canada ( SPARCC ) method for the SI joints and the SPARCC 6-discovertebral unit method for the spine .
-METHODS	Positive evidence of inflammation on MRI was defined as a SPARCC score of 2 for either the SI joints or the spine .
-RESULTS	Among patients with baseline SPARCC scores , 40 % had an SI joint score of 2 and 52 % had a spine score of 2 .
-RESULTS	Forty-nine percent of patients with baseline SI joint scores of < 2 , and 58 % of those with baseline SI joint scores of 2 , had a spine score of 2 .
-RESULTS	Comparison of baseline disease characteristics by baseline SI joint and spine scores showed that a greater proportion of patients in the subgroup with a baseline SPARCC score of 2 for both SI joints and spine were male , and patients with spine and SI joint scores of < 2 were younger and had shorter symptom duration .
-RESULTS	SPARCC spine scores correlated with baseline symptom duration , and SI joint scores correlated negatively with the baseline Bath Ankylosing Spondylitis Disease Activity Index , but neither correlated with the baseline Ankylosing Spondylitis Disease Activity Score , total back pain , the patient 's global assessment of disease activity , the Bath Ankylosing Spondylitis Functional Index , morning stiffness , nocturnal pain , or C-reactive protein level .
-CONCLUSIONS	Assessment by experienced readers showed that spinal inflammation on MRI might be observed in half of patients with nonradiographic axial SpA without SI joint inflammation .
-
-###25000665
-OBJECTIVE	To evaluate the effect of Clinpro XT Varnish ( VXT ) paste-liquid , resin-modified glass-ionomer and the resinous dentin desensitizing varnish and Gluma Dentin Desensitizer ( Gluma ) in treating dentin hypersensitivity ( DH ) .
-METHODS	This short-term ( 4-week ) randomized , double-blind , placebo-controlled , split-mouth study included a total of 119 teeth from 31 individuals which were randomized into three groups : VXT , Gluma , and placebo ( warm water ) .
-METHODS	Dentin sensitivity was evaluated by subjects ' perception of DH determined by pretreatment tooth sensitivity score ( TSS ) measured on a 0-10 visual analogue scale ( VAS ) after tactile ( probe ) or thermal/evaporative ( blast of air ) stimuli .
-METHODS	TSS was scored at baseline , immediately after treatment ( Day 0 ) , after 1 week and after 4 weeks .
-RESULTS	For both stimuli , mean TSS was significantly decreased in the VXT and Gluma groups at all time points ( all , P < 0.001 ) compared with baseline .
-RESULTS	Regarding comparisons of TSS between treatment groups , the VXT group had significantly lower mean TSS compared with the Gluma group ( P < 0.05 ) and placebo control group ( P < 0.05 ) at all time points after treatment regardless of stimuli .
-RESULTS	Group Effect , Time Effect , and Group x Time Effect were all significantly different ( all , P < 0.001 ) .
-
-###25748471
-BACKGROUND	The outcomes of double-bundle anterior cruciate ligament reconstruction ( DB-ACLR ) are becoming controversial .
-BACKGROUND	One of the main reasons for the controversy is the techniques for bone tunnel placement .
-BACKGROUND	The common technique to place the bone tunnels is to use bony landmarks , while a new approach uses footprint remnants .
-OBJECTIVE	To investigate if placement of double tunnels using bony landmarks produces the same clinical results as that of using existing footprint remnants .
-METHODS	Randomized controlled trial ; Level of evidence , 2 .
-METHODS	A total of 72 male patients were randomly divided into 2 groups of 36 patients each : ( A ) DB-ACLR tunnel placement using the footprint remnant procedure ( EF group ) and ( B ) DB-ACLR tunnel placement using the bony landmark procedure ( BL group ) .
-METHODS	All patients were evaluated before and after surgery .
-METHODS	Outcomes were measured by KT-2000 arthrometer side-to-side difference , pivot-shift test , and Tegner , Lysholm , and International Knee Documentation Committee ( IKDC ) scores .
-METHODS	Second-look arthroscopic evaluations were performed in 59 cases ( 28 and 31 cases in the EF and BL groups , respectively ) .
-RESULTS	The mean follow-up time was 36.94.8 months .
-RESULTS	Postoperative 3-dimensional computed tomography scans showed that bone sockets were variable on both femoral and tibial sides in the EF group and almost consistent in the BL group .
-RESULTS	All of the evaluation indexes were significantly improved postoperatively in both groups .
-RESULTS	There were no revision cases in the EF group and 2 in the BL group .
-RESULTS	The EF group showed a faster range of motion ( ROM ) recovery ( at 0 to 120 ) than did the BL group .
-RESULTS	At final follow-up , there was no significant difference between the EF and BL groups in Tegner score ( 5.881.39 vs 5.161.76 ; P = .058 ) or pivot-shift test ( 34 vs 32 ; P = .067 ) .
-RESULTS	The EF group had a larger proportion of patients with IKDC grade A ( normal ) ( 33 vs 24 ; P < .020 ) , smaller side-to-side difference ( 0.680.38 mm vs 1.230.61 mm ; P < .001 ) , higher Lysholm score ( 91.294.90 vs 88.715.09 ; P = .032 ) , and better second-look arthroscopic evaluations for graft quality in the anteromedial ( P = .034 ) , posterolateral ( P = .015 ) , and combined bundles ( P = .029 ) compared with the BL group .
-CONCLUSIONS	Although both techniques provided satisfactory clinical results , DB-ACLR using the existing footprint remnant for tunnel placement showed better functional results with respect to faster ROM recovery , higher subjective outcome scores , and better arthroscopic second-look with no revision cases .
-
-###24952700
-OBJECTIVE	This study sought to investigate the effect of a multiple micronutrient supplement on left ventricular ejection fraction ( LVEF ) in patients with heart failure .
-BACKGROUND	Observational studies suggest that patients with heart failure have reduced intake and lower concentrations of a number of micronutrients .
-BACKGROUND	However , there have been very few intervention studies investigating the effect of micronutrient supplementation in patients with heart failure .
-METHODS	This was a randomized , double-blind , placebo-controlled , parallel-group study involving 74 patients with chronic stable heart failure that compared multiple micronutrient supplementation taken once daily versus placebo for 12 months .
-METHODS	The primary endpoint was LVEF assessed by cardiovascular magnetic resonance imaging or 3-dimensional echocardiography .
-METHODS	Secondary endpoints were Minnesota Living With Heart Failure Questionnaire score , 6-min walk test distance , blood concentrations of N-terminal prohormone of brain natriuretic peptide , C-reactive protein , tumor necrosis factor alpha , interleukin-6 , interleukin-10 , and urinary levels of 8-iso-prostaglandin F2 alpha .
-RESULTS	Blood concentrations of a number of micronutrients increased significantly in the micronutrient supplement group , indicating excellent compliance with the intervention .
-RESULTS	There was no significant difference in mean LVEF at 12 months between treatment groups after adjusting for baseline ( mean difference : 1.6 % , 95 % confidence interval : -2.6 to 5.8 , p = 0.441 ) .
-RESULTS	There was also no significant difference in any of the secondary endpoints at 12 months between treatment groups .
-CONCLUSIONS	This study provides no evidence to support the routine treatment of patients with chronic stable heart failure with a multiple micronutrient supplement .
-CONCLUSIONS	( Micronutrient Supplementation in Patients With Heart Failure [ MINT-HF ] ; NCT01005303 ) .
-
-###24595965
-BACKGROUND	Metformin is suggested to reduce pregnancy complications in women with polycystic ovary syndrome ( PCOS ) .
-BACKGROUND	Metformin crosses the placenta and therapeutic concentrations are measured in the fetal circulation .
-BACKGROUND	Whether metformin treatment in pregnant PCOS women affects maternal and fetal insulin concentrations at birth is not clarified .
-OBJECTIVE	To investigate the possible effect of metformin on insulin concentrations in umbilical cord blood and the possible association between maternal and fetal insulin concentrations .
-METHODS	Post-hoc analysis of a subgroup of PCOS women participating in a double-blind randomized controlled trial .
-METHODS	University hospital setting .
-METHODS	Women with PCOS ( n = 118 ) , aged 19-39 years .
-METHODS	Maternal and umbilical cord insulin concentrations immediately after birth .
-RESULTS	At delivery women randomized to metformin had lower insulin concentrations than those randomized to placebo ( 259209 vs 361261pmol/l ; P = 0.020 ) .
-RESULTS	No difference was found in insulin concentrations in umbilical venous ( P = 0.95 ) and arterial ( P = 0.39 ) blood between the metformin and placebo groups .
-RESULTS	The arteriovenous difference was also equal between the groups ( P = 0.38 ) .
-RESULTS	Insulin concentrations were higher in the umbilical vein than in the umbilical artery independent of randomization ( 7051 vs 4548pmol/l ; P < 0.0005 ) .
-CONCLUSIONS	In PCOS , metformin treatment during pregnancy resulted in lower maternal insulin concentrations at delivery .
-CONCLUSIONS	Metformin treatment did not affect fetal insulin concentrations .
-CONCLUSIONS	Higher insulin concentrations in the umbilical vein indicate that the placenta somehow secretes insulin to the fetus .
-CONCLUSIONS	The possibility of placental insulin secretion to the fetus deserves further investigations .
-
-###24752448
-BACKGROUND	Sequential bacillus Calmette-Guerin ( BCG ) and electromotive mitomycin ( sequential therapy ) have been shown in a randomized prospective trial to be superior to therapy with BCG alone in patients with high-risk non-muscle-invasive bladder cancer .
-BACKGROUND	The objective of the current study was to compare the costs and benefits of these 2 treatment strategies by performing a 5-year and 10-year cost-effectiveness study .
-METHODS	A Markov model was developed to estimate the incremental cost-effectiveness ratio over a 5-year and 10-year period .
-METHODS	Estimates of disease progression , death , and treatment efficacy were obtained from what to the authors ' knowledge is the only randomized trial comparing the 2 therapies .
-METHODS	Costs included : 1 ) medical costs ( physician fees ) ; 2 ) drug costs ( preparation and instillation ) ; and 3 ) hospital costs ( procedure fees , admission fees , and tests and procedures done during surveillance ) .
-METHODS	Patients were allowed a second course of induction therapy .
-RESULTS	Sequential therapy was found to be associated with a higher initial material cost for induction and maintenance .
-RESULTS	The average effectiveness for the patients treated with therapy with BCG alone was 4.39 years with a mean cost of $ 9236 ( 95 % confidence interval , $ 9118 - $ 9345 ) per patient .
-RESULTS	The sequential group resulted in an average effectiveness of 4.65 years , with a mean cost of $ 16,468 ( 95 % confidence interval , $ 16,371 - $ 16,527 ) .
-RESULTS	The 5-year incremental cost-effectiveness ratio of sequential versus BCG-alone therapy was $ 27,815 per life-year gained .
-RESULTS	The corresponding figure over a 10-year period was $ 8618 per life-year gained .
-CONCLUSIONS	The results of the current study suggest that sequential therapy is a cost-effective treatment for patients with high-risk non-muscle-invasive bladder cancer .
-
-###24931840
-BACKGROUND	Cross-match-compatible platelets are used to support thrombocytopenic patients who are refractory to randomly selected platelets .
-BACKGROUND	However , few studies have addressed the efficacy of using this strategy for patients requiring intensive platelet transfusion therapy .
-BACKGROUND	The aim of this study was to determine the effectiveness of cross-match-compatible platelets in an unselected group of patients refractory to platelets from random donors .
-METHODS	A total of 406 cross-match-compatible platelet components were administered to 40 evaluable patients who were refractory to random-donor platelets .
-METHODS	A solid-phase red cell adherence method was used for platelet cross-matching .
-METHODS	The corrected count increment was used to monitor the effectiveness of each platelet transfusion .
-METHODS	Multivariate analysis was performed to detect whether any variables could predict the response to transfusion .
-RESULTS	Statistically significant improvements were found in the mean corrected count increment when comparing cross-match-compatible platelets with randomly selected and incompatible platelets ( p < 0.001 for each ) .
-RESULTS	Compatible platelet transfusions were associated with a good response in 72.9 % of cases while incompatible platelets were associated with a poor response in 66.7 % of transfusion events ( p < 0.001 ) .
-RESULTS	In the presence of clinical factors or alloimmunisation , compatible platelets were associated with good responses in 67.9 % and 28.0 % respectively vs 100 % and 93.3 % in their absence ( p = 0.009 , p < 0.001 ) .
-RESULTS	Multivariate analysis revealed that cross-matching and alloimmunisation were the strongest predictors of transfusion response at 1 hour , while ABO compatibility , type of units received , followed by alloimmunisation then clinical factors were predictors at 24 hours .
-CONCLUSIONS	Platelet cross-matching using the solid-phase red cell adherence technique is an effective and rapid first-line approach for the management of patients refractory to platelet transfusions .
-
-###25450120
-OBJECTIVE	To evaluate the effect of scapular stabilization during horizontal adduction stretching ( cross-body ) on posterior shoulder tightness ( PST ) and passive internal rotation ( IR ) .
-METHODS	Randomized controlled trial with single blinding .
-METHODS	Athletic club .
-METHODS	Asymptomatic volleyball players who are women with glenohumeral internal rotation deficit ( N = 60 ) .
-METHODS	Subjects were randomly assigned to either horizontal adduction stretching with manual scapular stabilization ( n = 30 ) or horizontal adduction stretching without stabilization ( n = 30 ) .
-METHODS	Passive stretching was performed for 3 - to 30-second holds in both groups .
-METHODS	Range of motion measurements of PST and IR were performed on the athlete 's dominant shoulder prior to and immediately after the intervention .
-RESULTS	Baseline mean angular measurements of PST and IR for all athletes involved in the study were 6214 and 4010 , respectively , with no significant difference between groups ( P = .598 and P = .734 , respectively ) .
-RESULTS	Mean PST measurements were significantly different between groups after the horizontal adduction stretch , with a mean angle of 8317 among the scapular stabilization group and 6513 among the nonstabilization group ( P < .001 ) .
-RESULTS	Measurements of IR were also significantly different between groups , with a mean angle of 5114 among the scapular stabilization group and 439 among the nonstabilization group ( P = .006 ) .
-CONCLUSIONS	Horizontal adduction stretches performed with scapular stabilization produced significantly greater improvements in IR and PST than horizontal adduction stretching without scapular stabilization .
-
-###25272316
-BACKGROUND	Early goal-directed therapy ( EGDT ) has been endorsed in the guidelines of the Surviving Sepsis Campaign as a key strategy to decrease mortality among patients presenting to the emergency department with septic shock .
-BACKGROUND	However , its effectiveness is uncertain .
-METHODS	In this trial conducted at 51 centers ( mostly in Australia or New Zealand ) , we randomly assigned patients presenting to the emergency department with early septic shock to receive either EGDT or usual care .
-METHODS	The primary outcome was all-cause mortality within 90 days after randomization .
-RESULTS	Of the 1600 enrolled patients , 796 were assigned to the EGDT group and 804 to the usual-care group .
-RESULTS	Primary outcome data were available for more than 99 % of the patients .
-RESULTS	Patients in the EGDT group received a larger mean ( SD ) volume of intravenous fluids in the first 6 hours after randomization than did those in the usual-care group ( 19641415 ml vs. 17131401 ml ) and were more likely to receive vasopressor infusions ( 66.6 % vs. 57.8 % ) , red-cell transfusions ( 13.6 % vs. 7.0 % ) , and dobutamine ( 15.4 % vs. 2.6 % ) ( P < 0.001 for all comparisons ) .
-RESULTS	At 90 days after randomization , 147 deaths had occurred in the EGDT group and 150 had occurred in the usual-care group , for rates of death of 18.6 % and 18.8 % , respectively ( absolute risk difference with EGDT vs. usual care , -0.3 percentage points ; 95 % confidence interval , -4.1 to 3.6 ; P = 0.90 ) .
-RESULTS	There was no significant difference in survival time , in-hospital mortality , duration of organ support , or length of hospital stay .
-CONCLUSIONS	In critically ill patients presenting to the emergency department with early septic shock , EGDT did not reduce all-cause mortality at 90 days .
-CONCLUSIONS	( Funded by the National Health and Medical Research Council of Australia and the Alfred Foundation ; ARISE ClinicalTrials.gov number , NCT00975793 . )
-
-###24549261
-OBJECTIVE	The purpose of this study was to investigate the incidence of cyclops lesions and its relationship with the cross-sectional area of the intercondylar notch .
-METHODS	For this study , 55 patients ( 24 male and 31 female ) underwent follow-up arthroscopy after bi-socket anterior cruciate ligament reconstruction with hamstring tendon grafts were included .
-METHODS	All patients underwent magnetic resonance imaging measurements of intercondylar notch dimensions .
-METHODS	We compared the femoral intercondylar notch sizes and bone tunnel sizes between knees with cyclops lesions ( cyclops group ) and those without cyclops lesions ( no-cyclops group ) .
-METHODS	The mean percentage of the tunnel size to the cross-sectional area of the femoral intercondylar notch was also compared between the groups .
-METHODS	The median follow-up duration was 3.8 years .
-RESULTS	Cyclops lesions were found in 15 of the 55 knees ( 27.3 % ) on second-look arthroscopy ( cyclops group ) .
-RESULTS	Only 6 of the 55 knees ( 10.9 % ) had extension loss ( cyclops syndrome ) .
-RESULTS	The cyclops group included 3 men and 12 women .
-RESULTS	The two groups showed a statistical difference in sex variation ( P = 0.04 ) .
-RESULTS	No significant differences were found in the femoral and tibial tunnel sizes between the two groups .
-RESULTS	The cross-sectional area of the femoral intercondylar notch was significantly smaller in the cyclops group ( 251.763.2 mm ( 2 ) ) than in the no-cyclops group ( 335.677.6 mm ( 2 ) ) ( P < 0.001 ) .
-RESULTS	The percentage of the total femoral tunnel size to the cross-sectional area of the femoral intercondylar notch was significantly higher in the cyclops group ( 18.65.3 % ) than in the no-cyclops group ( 13.23.6 % ) ( P = 0.02 ) .
-CONCLUSIONS	A smaller intercondylar notch size may be a potential risk factor for cyclops lesion formation .
-METHODS	Case-control study , Level IV .
-
-###24305963
-OBJECTIVE	Pancreatic islet transplantation stabilises glycaemic control in type 1 diabetes mellitus patients with neuroglycopoenia , despite them not achieving insulin independence because of limited graft function .
-OBJECTIVE	However , the extent and underlying metabolic pathways of restored glucose counterregulation are unknown .
-OBJECTIVE	We therefore compared systemic glucose turnover , including lactate gluconeogenesis ( GN ) and muscle glucose uptake , in individuals with type 1 diabetes who were transplant recipients with partial graft function ( T1DM/ITx ( + ) ) , matched non-transplanted individuals with type 1 diabetes ( T1DM/ITx ( - ) ) and matched healthy non-diabetic individuals .
-METHODS	Participants ( n = 12 in each group ) underwent a euglycaemic and a hypoglycaemic ( 2.5-2 .8 mmol/l ) hyperinsulinaemic clamp ( 0.8 mU kg ( -1 ) min ( -1 ) ) in a randomised crossover fashion .
-METHODS	Systemic and skeletal muscle glucose and lactate kinetics were assessed using a combination of isotopic and forearm balance techniques .
-RESULTS	Whole-body glucose counterregulation , the difference in glucose infusion rates required to maintain the glycaemic goal between the hypoglycaemic and euglycaemic clamps , was improved in T1DM/ITx ( + ) ( 7.81.3 mol kg ( -1 ) min ( -1 ) ) compared with T1DM/ITx ( - ) ( 0.30.9 mol kg ( -1 ) min ( -1 ) ) , but was ~ 45 % lower than in controls ( 14.12.1 mol kg ( -1 ) min ( -1 ) ) .
-RESULTS	Increased endogenous glucose production ( EGP ) and decreased systemic glucose disposal accounted for 49 % and 39 % of glucose counterregulation in T1DM/ITx ( + ) , respectively , compared with 60 % and 36 % in controls .
-RESULTS	Lactate GN increased in T1DM/ITx ( + ) ( 2.70.4 mol kg ( -1 ) min ( -1 ) ) and controls ( 1.70.5 mol kg ( -1 ) min ( -1 ) ) , such that it accounted for 70 % and 20 % of the increased EGP , respectively .
-RESULTS	Skeletal muscle accounted for similar proportions of the decrease in systemic glucose disposal in controls ( 49 % ) and T1DM/ITx ( + ) ( 41 % ) .
-CONCLUSIONS	Partial islet graft function improves hypoglycaemia counterregulation by increasing EGP , largely via lactate GN and decreasing systemic glucose disposal .
-CONCLUSIONS	This may explain the reduction in severe hypoglycaemic events in T1DM/ITx ( + ) individuals .
-BACKGROUND	ClinicalTrials.gov NCT01668485 .
-
-###25948780
-BACKGROUND	Advancing age is linked to a decrease in beneficial bacteria such as Bifidobacterium spp .
-BACKGROUND	and reduced aspects of innate immune function .
-OBJECTIVE	We investigated whether daily consumption of a probiotic [ Bacillus coagulans GBI-30 , 6086 ( BC30 ) ; GanedenBC ( 30 ) ] could improve immune function and gut function in men and women aged 65-80 y , using a double-blind , placebo-controlled crossover design .
-METHODS	Thirty-six volunteers were recruited and randomly assigned to receive either a placebo ( microcrystalline cellulose ) or the probiotic BC30 ( 1 10 ( 9 ) colony-forming units/capsule ) .
-METHODS	Volunteers consumed 1 treatment capsule per day for 28 d , followed by a 21-d washout period before switching to the other treatment .
-METHODS	Blood and fecal samples were collected at the beginning and end of each treatment period .
-METHODS	Fecal samples were used to enumerate bacterial groups and concentrations of calprotectin .
-METHODS	Peripheral blood mononuclear cells ( PBMCs ) were extracted from whole blood to assess natural killer cell activity and lipopolysaccharide ( LPS ) - stimulated cytokine production .
-METHODS	C-reactive protein concentrations were measured in plasma .
-RESULTS	Consumption of BC30 significantly increased populations of Faecalibacterium prausnitzii by 0.1 log10 cells/mL more than during consumption of the placebo ( P = 0.03 ) , whereas populations of Bacillus spp .
-RESULTS	increased significantly by 0.5 log10 cells/mL from baseline in volunteers who consumed BC30 ( P = 0.007 ) .
-RESULTS	LPS-stimulated PBMCs showed a 0.2 ng/mL increase in the anti-inflammatory cytokine IL-10 28 d after consumption of BC30 ( P < 0.05 ) , whereas the placebo did not affect IL-10 , and no overall difference was found in the effect of the treatments .
-CONCLUSIONS	Daily consumption of BC30 by adults aged 65-80 y can increase beneficial groups of bacteria in the human gut and potentially increase production of anti-inflammatory cytokines .
-CONCLUSIONS	This study shows the potential benefits of a probiotic to improve dysbiosis via modulation of the microbiota in older persons .
-
-###25441247
-OBJECTIVE	We compare the frequency of airway and respiratory adverse events leading to an intervention between propofol with 1:1 and 4:1 mixtures of propofol and ketamine ( ketofol ) .
-METHODS	We performed a randomized , double-blinded trial in which emergency department adults undergoing deep sedation received propofol , 1:1 propofol and ketamine , or 4:1 propofol and ketamine .
-METHODS	Our primary outcome was the frequency of airway and respiratory adverse events leading to an intervention .
-METHODS	Other outcomes included sedation depth , efficacy , procedure and recovery time , patient satisfaction , pain , and procedural recall .
-RESULTS	Two hundred seventy-one subjects completed the trial , 90 receiving propofol , 85 receiving 1:1 propofol and ketamine , and 96 receiving 4:1 propofol and ketamine .
-RESULTS	Airway or respiratory adverse events leading to an intervention were similar between groups : 29 % , 19 % , and 32 % , respectively ( P = .21 ) .
-RESULTS	There were no serious adverse events in any group .
-RESULTS	Secondary outcomes were generally similar between groups , with greater recovery agitation observed in the 1:1 ketofol group ( 8 % , 21 % , and 10 % , respectively ) .
-CONCLUSIONS	We found a similar frequency of airway and respiratory adverse events leading to intervention between propofol alone and either 1:1 or 4:1 ketofol .
-
-###25377297
-OBJECTIVE	To examine the effectiveness of a standardised Urinary Continence Physiotherapy Programme for older Chinese women with stress , urge , or mixed urinary incontinence .
-METHODS	A controlled trial .
-METHODS	Six elderly community health centres in Hong Kong .
-METHODS	A total of 55 women aged over 65 years with mild-to-moderate urinary incontinence .
-METHODS	Participants were randomly assigned to the intervention group ( n = 27 ) where they received eight sessions of Urinary Continence Physiotherapy Programme for 12 weeks .
-METHODS	This group received education about urinary incontinence , pelvic floor muscle training with manual palpation and verbal feedback , and behavioural therapy .
-METHODS	The control group ( n = 28 ) was given advice and an educational pamphlet on urinary incontinence .
-RESULTS	There was significant improvement in urinary symptoms in the intervention group , especially in the first 5 weeks .
-RESULTS	Compared with the control group , participants receiving the intervention showed significant reduction in urinary incontinence episodes per week with a mean difference of -6.4 ( 95 % confidence interval , -8.9 to -3.9 ; t = -5.3 ; P < 0.001 ) and significant improvement of quality of life with a mean difference of -3.93 ( 95 % confidence interval , -5.08 to -2.78 ; t = -6.9 ; P < 0.001 ) measured by Incontinence Impact Questionnaire Short Form modified Chinese ( Taiwan ) version .
-RESULTS	The subjective perception of improvement , measured by an 11-point visual analogue scale , was markedly better in the intervention group ( mean , 8.7 ; standard deviation , 1.0 ; 95 % confidence interval , 8.4-9 .1 ) than in the control group ( mean , 1.4 ; standard deviation , 0.7 ; 95 % confidence interval , 1.2-1 .7 ; t = 33.9 ; P < 0.001 ) .
-RESULTS	The mean treatment satisfaction in the intervention group was 9.5 ( standard deviation , 0.8 ) as measured by an 11-point visual analogue scale .
-CONCLUSIONS	This study demonstrated that the Urinary Continence Physiotherapy Programme was effective in alleviating urinary symptoms among older Chinese women with mild-to-moderate heterogeneous urinary incontinence .
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-###24252714
-OBJECTIVE	To determine if motivational interviewing ( MI ) improves self-efficacy ( primary outcome ) , depressive symptoms ( secondary outcome ) , and stage-of-readiness-to-change ( secondary outcome ) among women in abusive relationships .
-METHODS	Randomized controlled trial among women who experienced intimate partner violence in a current relationship over the past 12 months .
-METHODS	Subjects were recruited from two family planning clinics ( December 2007 to May 2010 ) .
-METHODS	The intervention included an initial face-to-face session and three telephone sessions administered 1 - , 2 - , and 4-months postenrollment , each using MI to identify personal goals .
-METHODS	Controls were referred to community-based resources .
-METHODS	Outcomes were measured by self-administered questionnaires before randomization and 6 months later .
-METHODS	Modified intent-to-treat analyses of completed participants were conducted using multivariate analysis of variance for continuous outcomes and polytomous logistic regression for categorical outcomes .
-RESULTS	Three hundred six eligible women were enrolled ( recruitment rate = 64 % ) ; 204 completed the 6-month follow-up ( completion rate = 67 % ) .
-RESULTS	Depressive symptoms decreased to a greater extent in MI than referral women ( P = .07 ) .
-RESULTS	Self-efficacy and stage-of-readiness-to-change increased more in MI than referral women , but these differences were not statistically significant .
-CONCLUSIONS	With a lower than projected sample size , our findings did not achieve statistical significance at the 5 % level but suggest a beneficial effect of the MI intervention on reducing depressive symptoms .
-
-###25892575
-OBJECTIVE	To evaluate the effectiveness of total laparoscopic hysterectomy compared with laparoscopic supracervical hysterectomy for alleviating dysmenorrhoea .
-METHODS	Randomised blinded controlled trial .
-METHODS	Norwegian university teaching hospital .
-METHODS	Sixty-two women with dysmenorrhoea .
-METHODS	Participants randomised to either total laparoscopic hysterectomy ( n = 31 ) or laparoscopic supracervical hysterectomy ( n = 31 ) .
-METHODS	The primary outcome measure , measured 12 months after intervention , was reduction of cyclic pelvic pain ( visual analogue scale , 0-10 ) .
-METHODS	Secondary outcome measures included patient satisfaction ( visual analogue scale , 0-10 ) and quality of life ( Short Form 36 , 0-100 ) .
-RESULTS	The groups were comparable at baseline .
-RESULTS	There was no difference in self-reported dysmenorrhoea at 12 months ( mean 0.8 [ SD 1.6 ] versus 0.8 [ SD 2.0 ] , P = 0.94 ) .
-RESULTS	There was no difference in patient satisfaction ( mean 9.3 [ SD 1.5 ] versus 9.1 [ SD 1.2 ] , P = 0.66 ) or quality of life ( mean 81.6 [ SD 17.8 ] versus 80.2 [ SD 18.0 ] , P = 0.69 ) .
-CONCLUSIONS	Improvement in dysmenorrhoea and quality of life as well as patient satisfaction were comparable in the medium term when comparing total laparoscopic hysterectomy with laparoscopic supracervical hysterectomy .
-
-###25361615
-BACKGROUND	For many individuals , daily commuting activities on roadways account for a substantial proportion of total exposure , as well as peak-level exposures , to traffic-related air pollutants ( TRAPS ) including ultrafine particles , but the health impacts of these exposures are not well-understood .
-BACKGROUND	We sought to determine if exposure to TRAPs particles during commuting causes acute oxidative stress in the respiratory tract or changes in heart rate variability ( HRV ) , a measure of autonomic activity .
-METHODS	We conducted a randomized , cross-over trial in which twenty-one young adults took two 1.5-hr rides in a passenger vehicle in morning rush-hour traffic .
-METHODS	The subjects wore a powered-air-purifying respirator , and were blinded to high-efficiency particulate air ( HEPA ) filtration during one of the rides .
-METHODS	At time points before and after the rides , we measured HRV and markers of oxidative stress in exhaled breath condensate ( EBC ) including nitrite , the sum of nitrite and nitrate , malondialdehyde , and 8-isoprostane .
-METHODS	We used mixed linear models to evaluate the effect of exposure on EBC and HRV outcomes , adjusting for pre-exposure response levels .
-METHODS	We used linear models to examine the effects of particle concentrations on EBC outcomes at post-exposure time points .
-RESULTS	Mean EBC nitrite and the sum of nitrite and nitrate were increased from baseline at immediately post-exposure comparing unfiltered to filtered rides ( 2.11 M vs 1.70 M , p = 0.02 and 19.1 M vs 10.0 M , p = 0.02 , respectively ) .
-RESULTS	Mean EBC malondialdehyde ( MDA ) concentrations were about 10 % greater following the unfiltered vs. filtered exposures , although this result was not statistically significant .
-RESULTS	We found no significant associations between exposure to traffic particles and HRV outcomes at any of the time points .
-RESULTS	At immediately post-exposure , an interquartile range increase in particle number concentration was associated with statistically significant increases in nitrite ( 99.4 % , 95 % CI 32.1 % to 166.7 % ) and nitrite + nitrate ( 75.7 % , 95 % CI 21.5 % to 130.0 % ) .
-CONCLUSIONS	Increases in markers of oxidative stress in EBC may represent early biological responses to widespread exposures to TRAPs particles that affect passengers in vehicles on heavily trafficked roadways .
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-###25266182
-OBJECTIVE	Off-pump coronary artery bypass grafting ( OPCAB ) is a popular treatment for patients with ischemic heart disease , especially for high-risk patients .
-OBJECTIVE	However , whether OPCAB can lead to better clinical outcomes than on-pump coronary artery bypass grafting ( ONCAB ) in patients with enlarged ventricles remains controversial .
-OBJECTIVE	This prospective randomized study was designed to characterize comparison of early clinical outcome and mid-term follow-up following ONCAB versus OPCAB in patients with triple-vessel disease and enlarged ventricles .
-METHODS	Prospective randomized trial of patients treated at The First Affiliated Hospital , China Medical University , over a 3-year period ( 2007-2010 ) .
-METHODS	A total of 102 patients with triple-vessel disease and enlarged ventricles ( end-diastolic dimension > = 6.0 cm ) were randomized to OPCAB or ONCAB between July 2007 and December 2010 .
-METHODS	The in-hospital out.comes were analyzed .
-METHODS	The study included a mid-term follow-up , with a mean follow-up time of 49.40 ( 12.88 months ) .
-RESULTS	No significant differences were recorded in the baseline clinical characteristics of ONCAB and OPCAB groups .
-RESULTS	A statistical difference was found between the two groups at the time of extubation , intensive care unit stay , hospital stay , blood requirements , incidence of intra-aortic balloon pump support , pulmonary complications , stroke , reoperation for bleeding , and inotropic requirements > 24 hours ( P < .05 ) .
-RESULTS	The number of anastomoses performed per patient , the incidence of postoperative ventricular arrhythmia , myocardial infarction , new-onset atrial fibrillation , hemodialysis , infective complications , recurrent angina , and percutaneous reintervention were similar between the 2 groups ( P > .05 ) .
-RESULTS	The left ventricular end-diastolic dimension was significantly smaller at 6 months ' follow-up in the 2 groups than it was before operation ( < .05 ) .
-RESULTS	No differences in hospital mortality and mid-term mortality between OPCAB and ONCAB groups were found .
-RESULTS	During the follow-up , no patient in either group had undergone repeat coronary artery bypass grafting .
-CONCLUSIONS	No differences in early and mid-term mortality were found between OPCAB and ONCAB in patients with triple-vessel disease and enlarged ventricles .
-CONCLUSIONS	However , OPCAB seems to have a beneficial effect on postoperative complications .
-
-###25636550
-BACKGROUND	The aim of this study was to compare the esthetic judgments of orthodontists and laypeople regarding the appearance of palatally displaced canines 3 months after treatment with either a closed or an open surgical exposure and orthodontic alignment .
-METHODS	A multicenter randomized controlled trial was undertaken in 3 hospitals in the United Kingdom .
-METHODS	Patients with unilateral palatally displaced canines were randomly allocated to receive either a closed or an open surgical exposure .
-METHODS	The teeth were aligned with fixed appliances , and 3 months after debond , intraoral photographs were taken .
-METHODS	The photographs were projected in random order to 2 panels of judges ( orthodontists and laypeople ) , who completed a questionnaire .
-RESULTS	The images of 67 participants ( closed , 33 ; open , 34 ) were included .
-RESULTS	The laypeople were able to identify the operated tooth only 49.7 % of the time ( 95 % CI , 45.3 % -54.0 % ) ; this was no better than chance ( P = 0.880 ) .
-RESULTS	The orthodontists were more successful but still identified the treated canine with certainty only 60.7 % of the time ( 95 % CI , 53.7 % -67.8 % ; P = 0.003 ) .
-RESULTS	Both panels more frequently assessed the unoperated canine to have a better appearance than the contralateral operated canine ; however , there were no differences between the closed and open groups ( proportion preferring unoperated canine-laypeople : closed , 58.7 % ; open , 57.0 % ; P = 0.43 ; and orthodontists : closed , 60.9 % ; open , 60.6 % ; P = 0.27 ) .
-CONCLUSIONS	There is an esthetic impact to aligning a palatally displaced canine , but it is mostly minor and unlikely to be detectable by laypeople .
-CONCLUSIONS	The esthetic impact was the same , whether the canine was exposed with a closed or an open surgical technique .
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-###25661397
-BACKGROUND	Rumination is one of the hallmark characteristics of both anxiety disorders and depression , and has been linked to deficient executive functioning , particularly working memory ( WM ) .
-BACKGROUND	Previous findings show that working memory capacity can be increased through training .
-METHODS	The current study explored whether an adaptive stand-alone WM training could increase WMC and consequently reduce rumination , anxiety and depression by means of a double-blind randomized controlled trial in a sample of 98 patients with symptoms of anxiety and/or depression .
-RESULTS	No positive effect of training on WMC was found .
-RESULTS	In addition , the results show that a WM training was not associated with a reduction of rumination , depression , nor anxiety .
-CONCLUSIONS	The high drop-out rate in both groups ( 20.11 % from pre - to post-training ) and the overrepresentation of men and use of anti-depressants in the placebo group might have influenced the results .
-CONCLUSIONS	Furthermore , expectations and perceptions about the training might have interacted with performance on WM tasks .
-CONCLUSIONS	Overall , results show that a stand-alone WM training in patients with symptoms of anxiety and/or depression does not result in reduced rumination nor in reduced symptoms of depression and anxiety .
-CONCLUSIONS	We discuss potential explanations for these findings .
-
-###25241758
-OBJECTIVE	To evaluate the safety ( primary objective ) and efficacy ( secondary objective ) of ( - ) - OSU6162 in Huntington 's disease ( HD ) .
-METHODS	In a double-blind , cross-over trial , patients with HD were randomly assigned to start treatment on either ( - ) - OSU6162 or placebo .
-METHODS	After 4 weeks , those patients who initially received active drug were switched to placebo for another 4 weeks , and vice versa .
-METHODS	During the first week the ( - ) - OSU6162 dose was 15 mg twice daily , during the second week 30 mg twice daily , and during the last 2 weeks 45 mg twice daily .
-METHODS	Motor , cognitive , mental and social functions were rated by the clinical investigator or by self-assessment , using established rating scales .
-RESULTS	Fifteen patients fulfilling inclusion and exclusion criteria completed the study .
-RESULTS	( - ) - OSU6162 was well tolerated by all patients and no adverse effects were observed .
-RESULTS	( - ) - OSU6162 treatment significantly improved the Short Form 36 Vitality score , mainly due to an improvement of the individual item ` worn-out ' ( VT3 ) .
-RESULTS	In addition , an improvement of depressive symptoms was found using Beck Depression Inventory .
-RESULTS	In contrast to a general trend of improvement in several non-motor variables only small and non-significant differences between ( - ) - OSU6162 and placebo were found regarding motor functions .
-CONCLUSIONS	( - ) - OSU6162 offers promise for the treatment of HD , as a drug with good tolerability , capable of improving the patients ' experienced non-motor functions such as energy and mood and thus alleviating symptoms of great importance for their quality of life .
-
-###24935984
-BACKGROUND	Neurofilaments ( Nf ) are major structural proteins that occur exclusively in neurons .
-BACKGROUND	In spinal cord injury ( SCI ) , the severity of disease is quantified by clinical measures that have limited sensitivity and reliability , and no blood-based biomarker has been established to further stratify the degree of injury .
-BACKGROUND	We aimed to examine a serum-based NfL immunoassay as predictor of the clinical outcome in SCI .
-METHODS	Longitudinal measurement of serum NfL was performed in patients with central cord syndrome ( CCS , n = 4 ) , motor-incomplete SCI ( iSCI , n = 10 ) , motor-complete SCI ( cSCI , n = 13 ) and healthy controls ( HC , n = 67 ) , and correlated with clinical severity , neurological outcome , and neuroprotective effect of the drug minocycline .
-RESULTS	Baseline NfL levels were higher in iSCI ( 21pg/mL ) and cSCI ( 70pg/mL ) than in HC ( 5pg/mL , p = 0.006 and p < 0.001 ) and CCS ( 6pg/mL , p = 0.025 and p = 0.010 ) .
-RESULTS	Levels increased over time ( p < 0.001 ) and remained higher in cSCI versus iSCI ( p = 0.011 ) and than in CCS ( p < 0.001 ) .
-RESULTS	NfL levels correlated with American Spinal Injury Association ( ASIA ) motor score at baseline ( r = -0.53 , p = 0.004 ) and after 24h ( r = -0.69 , p < 0.001 ) and 3-12-month motor outcome ( baseline NfL : r = -0.43 , p = 0.026 and 24h NfL : r = -0.72 , p < 0.001 ) .
-RESULTS	Minocycline treatment showed decreased NfL levels in the subgroup of cSCI patients .
-CONCLUSIONS	Serum NfL concentrations in SCI patients show a close correlation with acute severity and neurological outcome .
-CONCLUSIONS	Our data provide evidence that serum NfL is of prognostic value in SCI patients for the first time .
-CONCLUSIONS	Further , blood NfL levels may qualify as drug response markers in SCI .
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-###24985691
-OBJECTIVE	The aim of this study was to evaluate the effectiveness of unstable shoes in reducing low back pain in health professionals .
-METHODS	Of a volunteer sample of 144 participants , 40 with nonspecific chronic low back pain were eligible and enrolled in this study .
-METHODS	Participants were randomized to an intervention group , who wore unstable shoes ( model MBT Fora ) , or a control group , who wore conventional sports shoes ( model Adidas Bigroar ) .
-METHODS	The participants had to wear the study shoes during their work hours , and at least 6 hours per workday , over a period of 6 weeks .
-METHODS	The primary outcome was low back pain assessed on a Visual Analog Scale .
-METHODS	The secondary outcomes were patient satisfaction , disability evaluated using Roland-Morris questionnaire and quality of life evaluated using EQ-VAS .
-RESULTS	The intervention group showed a significant decrease in pain scores compared to the control group .
-RESULTS	The rate of satisfaction was higher in the intervention group ( 79 % ) compared to the control group ( 25 % ) .
-RESULTS	There was no significant difference for the Roland-Morris disability questionnaire score and the EQ-VAS scale .
-CONCLUSIONS	The results of this clinical trial suggest that wearing unstable shoes for 6 weeks significantly decreases low back pain in patients suffering from chronic low back pain but had no significant effect on quality of life and disability scores .
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-###24831919
-BACKGROUND	We previously reported that compared to standard glycemic control [ blood glucose ( BG ) : 70-180 mg/dL ] , patients randomized to intensive glycemic control ( BG : 70-110 mg/dL ) were at increased risk of graft rejection in renal transplantation .
-BACKGROUND	However , the underlying mechanisms that associate the effect of intensive glycemic control with renal transplant outcomes have not been identified .
-METHODS	A secondary data analysis of 93 participants ( n = 44 intensive , n = 49 control ) was conducted using data from a previous randomized controlled clinical trial .
-METHODS	We examined inflammatory biomarkers , glycemic variability , hypoglycemia , and hyperglycemia as potential contributing etiologies by assessing the effect of intensive glycemic control on these characteristics , and evaluate the association of these variables with graft rejection .
-RESULTS	Intensive glycemic control had no appreciable effect on highly sensitive C-reactive protein , interleukin ( IL ) -6 , tumor necrosis factor alpha , IL-1 , or IL-10 levels at all time points after transplantation .
-RESULTS	Moreover , neither inflammatory biomarkers nor increased glycemic variability were associated with graft rejection .
-RESULTS	However , intensive treatment increased the risk of hypoglycemia ( BG < 70 mg/dL , 84 % vs. 25 % , P < 0.001 ) .
-RESULTS	In sub-analysis , compared to non-rejecters , rejecters demonstrated higher rates of blood glucose below 70 mg/dL ( 90 % vs. 49 % , P = 0.02 ) .
-CONCLUSIONS	Inflammatory biomarkers and increased glycemic variability lack correlation with clinical outcomes in renal transplant , but importantly , increased perioperative hypoglycemic episodes ( BG < 70mg/dL ) may be a salient etiology that contributed to the increased risk for acute allograft rejection related to intensive glycemic control .
-CONCLUSIONS	Further research is needed to confirm a causal association .
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-###26050541
-OBJECTIVE	To investigate the influence of glycosylated hemoglobin ( HbA1c ) on treatment outcomes in patients with diabetic macular edema ( DME ) receiving intravitreal ranibizumab .
-METHODS	Post hoc analysis of 2 identical phase III clinical trials assessing the efficacy and safety of intravitreal ranibizumab in DME over 36 months ( RIDE : NCT00473382/RISE : NCT00473330 ) .
-METHODS	A total of 483 adults with vision loss from DME treated with ranibizumab were included in this analysis from RIDE/RISE .
-METHODS	Participants received monthly intravitreal ranibizumab ( 0.3 or 0.5 mg ) .
-METHODS	Differences in visual and anatomic outcomes , and diabetic retinopathy ( DR ) severity score , between subgroups of patients with baseline HbA1c 7 % versus HbA1c > 7 % at 36 months .
-RESULTS	There were 195 patients in RIDE/RISE who were treated with ranibizumab with a baseline HbA1c 7 % and 288 patients with a baseline HbA1c > 7 % included in this analysis .
-RESULTS	The mean improvement in visual acuity ( VA ) at 36 months was +13 Early Treatment Diabetic Retinopathy Study ( ETDRS ) letters in patients with baseline HbA1c 7 % compared with +11 ETDRS letters in the patients with a baseline HbA1c > 7 % ( P = 0.17 ) .
-RESULTS	After adjustment for baseline central foveal thickness ( CFT ) and duration of diabetes , the mean CFT reduction was -268 m in patients with a baseline HbA1c 7 % and -269 m in patients with a baseline HbA1c > 7 % ( P = 0.98 ; 95 % confidence interval , -22.93 to 23.54 ) .
-RESULTS	The proportion of patients with a 2-step improvement in DR severity score was 38 % in patients with baseline HbA1c 7 % compared with 41 % in the patients with a baseline HbA1c > 7 % ( P = 0.53 ) .
-RESULTS	There was no correlation of baseline HbA1c with any visual or anatomic parameter .
-CONCLUSIONS	The improvement in VA , anatomic reduction of macular edema , and improvement in DR severity score with ranibizumab treatment seem to be independent of baseline HbA1c .
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-###24804695
-OBJECTIVE	To determine whether testosterone therapy improves glucose metabolism in men with type 2 diabetes ( T2D ) and lowered testosterone .
-METHODS	We conducted a randomized , double-blind , parallel , placebo-controlled trial in 88 men with T2D , aged 35-70 years with an HbA1c 8.5 % ( 69 mmol/mol ) , and a total testosterone level , measured by immunoassay , of 12.0 nmol/L ( 346 ng/dL ) .
-METHODS	Participants were randomly assigned to 40 weeks of intramuscular testosterone undecanoate ( n = 45 ) or matching placebo ( n = 43 ) .
-METHODS	All study subjects were included in the primary analysis .
-METHODS	Seven men assigned to testosterone and six men receiving placebo did not complete the study .
-METHODS	Main outcome measures were insulin resistance by homeostatic model assessment ( HOMA-IR , primary outcome ) and glycemic control by HbA1c ( secondary outcome ) .
-RESULTS	Testosterone therapy did not improve insulin resistance ( mean adjusted difference [ MAD ] for HOMA-IR compared with placebo -0.08 [ 95 % CI -0.31 to 0.47 ; P = 0.23 ] ) or glycemic control ( MAD HbA1c 0.36 % [ 0.0-0 .7 ] ; P = 0.05 ) , despite a decrease in fat mass ( MAD -2.38 kg [ -3.10 to -1.66 ] ; P < 0.001 ) and an increase in lean mass ( MAD 2.08 kg [ 1.52-2 .64 ] ; P < 0.001 ) .
-RESULTS	Testosterone therapy reduced subcutaneous ( MAD -320 cm ( 3 ) [ -477 to -163 ] ; P < 0.001 ) but not visceral abdominal adipose tissue ( MAD 140 cm ( 3 ) [ -89 to 369 ] ; P = 0.90 ) .
-CONCLUSIONS	Testosterone therapy does not improve glucose metabolism or visceral adiposity in obese men with moderately controlled T2D and modest reductions in circulating testosterone levels typical for men with T2D .
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-###24411819
-OBJECTIVE	To test the feasibility , acceptability and safety of a pediatric advance care planning intervention , Family-Centered Advance Care Planning for Teens With Cancer ( FACE-TC ) .
-METHODS	Adolescent ( age 14-20 years ) / family dyads ( N = 30 ) with a cancer diagnosis participated in a two-armed , randomized , controlled trial .
-METHODS	Exclusion criteria included severe depression and impaired mental status .
-METHODS	Acceptability was measured by the Satisfaction Questionnaire .
-METHODS	General Estimating Equations models assessed the impact of FACE-TC on 3-month post-intervention outcomes as measured by the Pediatric Quality of Life Inventory 4.0 Generic Core Scale , the Pediatric Quality of Life Inventory 4.0 Cancer-Specific Module , the Beck Depression and Anxiety Inventories , the Spiritual Well-Being Scale of the Functional Assessment of Chronic Illness Therapy-IV , and advance directive completion .
-RESULTS	Acceptability was demonstrated with enrollment of 72 % of eligible families , 100 % attendance at all three sessions , 93 % retention at 3-month post-intervention , and 100 % data completion .
-RESULTS	Intervention families rated FACE-TC worthwhile ( 100 % ) , whereas adolescents ' ratings increased over time ( 65 % -82 % ) .
-RESULTS	Adolescents ' anxiety decreased significantly from baseline to 3 months post-intervention in both groups ( = -5.6 ; p = .0212 ) .
-RESULTS	Low depressive symptom scores and high quality of life scores were maintained by adolescents in both groups .
-RESULTS	Advance directives were located easily in medical records ( 100 % of FACE-TC adolescents vs. no controls ) .
-RESULTS	Oncologists received electronic copies .
-RESULTS	Total Spirituality scores ( = 8.1 ; p = .0296 ) were significantly higher among FACE-TC adolescents versus controls .
-RESULTS	The FACE-TC adolescents endorsed the best time to bring up end-of-life decisions : 19 % before being sick , 19 % at diagnosis , none when first ill or hospitalized , 25 % when dying , and 38 % for all of the above .
-CONCLUSIONS	Family-Centered Advance Care Planning for Teens With Cancer demonstrated feasibility and acceptability .
-CONCLUSIONS	Courageous adolescents willingly participated in highly structured , in-depth pediatric advance care planning conversations safely .
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-###25179592
-OBJECTIVE	We report the results of long-term follow-up of the Pacing to Avoid Cardiac Enlargement ( PACE ) trial , a prospective , double-blinded , randomized , multicentre study that confirmed the superiority of biventricular ( BiV ) pacing compared with right ventricular apical ( RVA ) pacing in prevention of LV adverse remodelling and deterioration of systolic function at 1 and 2 years .
-RESULTS	Patients with bradycardia and preserved LVEF were randomized to receive RVA ( n = 88 ) or BiV pacing ( n = 89 ) .
-RESULTS	Co-primary endpoints were LV end-systolic volume ( LVESV ) and LVEF measured by echocardiography .
-RESULTS	There were 149 patients who had extended follow-up , with a mean duration of 4.8 1.5 years ( 2.5-7 .8 years ) .
-RESULTS	The primary endpoint analyses were performed in 146 patients ( 74 in the RVA group and 72 in the BiV group ) .
-RESULTS	In the RVA pacing group , the LVEF decreased while the LVESV increased progressively at follow-up , but remained unchanged in the BiV pacing group .
-RESULTS	The differences in LVEF between the RVA and BiV groups were -6.3 , -9.2 , and -10.7 % at 1-year , 2-year , and long-term follow-up , respectively ( all P < 0.001 ) .
-RESULTS	The corresponding differences in LVESV were +7.4 , +9.9 , and +13.1 mL , respectively ( all P < 0.001 ) .
-RESULTS	The deleterious effects of RVA pacing consistently occurred in all the pre-defined subgroups .
-RESULTS	Furthermore , patients with RVA pacing had a significantly higher prevalence of heart failure hospitalization than the BiV group ( 23.9 % vs. 14.6 % , log-rank = 7.55 , P = 0.006 ) .
-CONCLUSIONS	Left ventricular adverse remodelling and deterioration of systolic function continued at long-term follow-up in patients with RVA pacing ; this deterioration was prevented by the use of BiV pacing .
-CONCLUSIONS	Also , heart failure hospitalization was more prevalent in the RVA pacing group .
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-###24554232
-OBJECTIVE	No highly effective interventions to prevent delirium have been identified .
-OBJECTIVE	To examine whether ramelteon , a melatonin agonist , is effective for the prevention of delirium .
-METHODS	A multicenter , rater-blinded , randomized placebo-controlled trial was performed in intensive care units and regular acute wards of 4 university hospitals and 1 general hospital .
-METHODS	Eligible patients were 65 to 89 years old , newly admitted due to serious medical problems , and able to take medicine orally .
-METHODS	Patients were excluded from the study if they had an expected stay or life expectancy of less than 48 hours .
-METHODS	Sixty-seven patients were randomly assigned using the sealed envelope method to receive ramelteon ( 8 mg/d ; 33 patients ) or placebo ( 34 patients ) every night for 7 days .
-METHODS	Incidence of delirium , as defined by the Diagnostic and Statistical Manual of Mental Disorders ( Fourth Edition ) .
-RESULTS	Ramelteon was associated with a lower risk of delirium ( 3 % vs 32 % ; P = .003 ) , with a relative risk of 0.09 ( 95 % CI , 0.01-0 .69 ) .
-RESULTS	Even after risk factors were controlled for , ramelteon was still associated with a lower incidence of delirium ( P = .01 ; odds ratio , 0.07 [ 95 % CI , 0.008-0 .54 ] ) .
-RESULTS	The Kaplan-Meier estimates of time to development of delirium were 6.94 ( 95 % CI , 6.82-7 .06 ) days for ramelteon and 5.74 ( 5.05-6 .42 ) days for placebo .
-RESULTS	Comparison by log-rank test showed that the frequency of delirium was significantly lower in patients taking ramelteon than in those taking placebo ( ( 2 ) = 9.83 ; P = .002 ) .
-CONCLUSIONS	Ramelteon administered nightly to elderly patients admitted for acute care may provide protection against delirium .
-CONCLUSIONS	This finding supports a possible pathogenic role of melatonin neurotransmission in delirium .
-BACKGROUND	University Hospital Medical Information Network Clinical Trials Registry Identifier : UMIN000005591 .
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-###25294090
-OBJECTIVE	Consumption of energy drinks is increasing amongst athletes and the general public .
-OBJECTIVE	By virtue of their bioactive ingredients ( including caffeine , taurine , glucuronolactone , and B-group vitamins ) and paucity of calories , sugar-free `` diet '' versions of these drinks could be a useful aid for weight maintenance .
-OBJECTIVE	Yet little is known about the acute influence of these drinks , and specifically the role of the cocktail of non-caffeine ingredients , on resting energy expenditure ( REE ) and substrate oxidation .
-OBJECTIVE	Therefore , the metabolic impact of sugar-free Red Bull ( sfRB ) to a comparable amount of caffeine was compared .
-METHODS	REE and respiratory quotient ( RQ ) were measured in eight healthy young men by ventilated-hood indirect calorimetry for 30 min baseline and 2 h following ingestion of 355 ml of either : sfRB + placebo , water +120 mg caffeine , or water + placebo , according to a randomized cross-over design .
-RESULTS	sfRB and water + caffeine both increased REE to the same degree ( +4 % ) .
-RESULTS	Additionally , sfRB briefly increased RQ .
-RESULTS	Water + caffeine had no effect on RQ relative to water + placebo .
-CONCLUSIONS	sfRB enhanced thermogenesis and marginally shifted RQ to favor carbohydrate oxidation .
-CONCLUSIONS	The stimulatory effects of sfRB on REE are mimicked by water + caffeine , indicating that the auxiliary ingredients do not influence this thermic effect .
-CONCLUSIONS	The metabolic effects of sfRB are primarily due to caffeine alone .
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-###24578471
-BACKGROUND	Guidelines recommend saline hydration for prophylaxis of contrast-induced acute kidney injury ( CI-AKI ) in patients with chronic kidney disease ( CKD ) undergoing intravenous contrast media-enhanced CT ( CE-CT ) .
-BACKGROUND	The safety and efficacy of a brief hydration protocol using sodium bicarbonate in this population is unknown .
-BACKGROUND	We analysed whether 1-h sodium bicarbonate hydration prior to CE-CT is non-inferior to saline hydration prior to and after CE-CT in CKD patients .
-METHODS	We performed an open-label multicentre randomized trial .
-METHODS	Patients were randomized to 250 mL of 1.4 % sodium bicarbonate hydration prior to CE-CT or 1000 mL of 0.9 % saline hydration prior to and , once again , after CE-CT .
-METHODS	Primary outcome was the relative increase in serum creatinine 48-96 h post-CE-CT .
-METHODS	Secondary outcomes were incidence of CI-AKI [ serum creatinine increase > 25 % / > 44 mol/L ( 0.5 mg/dL ) ] , recovery of renal function , the need for dialysis and 2-month hospital costs .
-RESULTS	Five hundred and seventy adult CKD patients undergoing CE-CT were randomized between 2010 and 2012 , of whom 548 were included in the intention-to-treat population .
-RESULTS	Mean relative serum creatinine increase was 1.2 % for sodium bicarbonate and 1.5 % for saline ( mean difference -0.3 % ; 95 % confidence interval -2.7 to 2.1 , P-value for non-inferiority < 0.0001 ) .
-RESULTS	CI-AKI occurred in 22 patients ( 4.1 % ) ; 8 ( 3.0 % ) randomized to sodium bicarbonate versus 14 ( 5.1 % ) to saline ( P = 0.23 ) .
-RESULTS	Renal function recovered in 75 and 69 % of CI-AKI patients , respectively ( P = 0.81 ) .
-RESULTS	No patients developed a need for dialysis .
-RESULTS	Mean hydration costs per patient were 224 for the sodium bicarbonate and 683 for the saline regime ( P < 0.001 ) .
-RESULTS	Other healthcare costs were similar .
-CONCLUSIONS	Short hydration with sodium bicarbonate prior to CE-CT was non-inferior to peri-procedural saline hydration with respect to renal safety and may result in healthcare savings .
-CONCLUSIONS	[ Netherlands Trial Register ( http://www.trialregister.nl/trialreg/index.asp ) , Nr 2149 , date of registration 23 December 2009 . ]
-
-###24228935
-BACKGROUND	Successful recruitment of participants to any trial is central to its success .
-BACKGROUND	Trial results are routinely published , and recruitment is often cited to be slower and more difficult than anticipated .
-BACKGROUND	This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom ( UK ) gynaecology outpatient clinics to a multi-centre randomised controlled trial ( RCT ) of physiotherapy , and the systems put in place in an attempt to address them .
-METHODS	Gynaecology outpatients with symptomatic prolapse were to be recruited over a 16-month period from 14 UK hospitals and one New Zealand hospital .
-METHODS	Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office .
-METHODS	Recruitment difficulties were encountered early on , and a number of strategies were employed to try to improve recruitment .
-RESULTS	Some strategies were more successful than others and they differed in the resources required .
-RESULTS	Actions that facilitated recruitment included increasing recruiting centres to 23 UK and two international hospitals , good centre support , using processes embedded in clinical practice , and good communication between the trial office , collaborators and participants .
-RESULTS	Collaborator incentives , whereby staff involved received the benefit immediately , were more successful than a nominal monetary payment per woman randomised .
-RESULTS	Barriers to recruitment included fewer eligible women than anticipated , patient 's preference to receive active treatment rather than allocation to the control group , lack of support staff and high staff turnover .
-RESULTS	Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner ( GP ) referral procedures also impacted negatively on recruitment .
-CONCLUSIONS	Our article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting .
-CONCLUSIONS	Effective interventions included increasing the number of recruiting centres and providing collaborator incentives .
-CONCLUSIONS	Barriers to recruitment included fewer eligible women than anticipated , patient 's preference to be allocated to the treatment group , lack of support staff , and variations in approval systems and GP referral procedures .
-CONCLUSIONS	To improve the evidence base on clinical trial recruitment , trialists need to publish their experiences and lessons learned .
-CONCLUSIONS	Future RCTs should evaluate , where possible , the effect of strategies designed to improve recruitment and retention .
-BACKGROUND	Current Controlled Trials ISRCTN35911035 .
-
-###25150368
-BACKGROUND	The hazardous health effects of smoking are established , but there remains a need to evaluate existing smoking prevention strategies and to increase their effectiveness in adolescents .
-BACKGROUND	Strategies focusing on parental attitudes and rule setting have been identified as a potentially effective approach .
-BACKGROUND	The present manuscript describes objectives , study design and methodology of the BEST Prevention study .
-METHODS	BEST Prevention is a three-armed cluster randomized-controlled trial among 7th grade ( 11-16 years ) students in Berlin , Germany .
-METHODS	Schools were enrolled between 2010 and 2011 and allocated using a centralized randomization list into 1 ) a student smoking prevention intervention ( visit to an established interactive circuit ) , 2 ) the same intervention plus a parent intervention , and 3 ) a control group ( visit to an established exercise and nutrition interactive circuit ) .
-METHODS	Students were assessed at baseline , 12 and 24 months via self-report , as well as via carbon monoxide and cotinine in saliva at the 24 month follow-up .
-METHODS	Statistical analyses uses multi-level regression models with cluster effects ( school and class within school ) based on the intention to treat population .
-METHODS	Here we report descriptive baseline characteristics of recruited schools , and schools classes .
-METHODS	Two schools from the control group dropped out after allocation .
-METHODS	Hence , 47 secondary schools from all 12 districts of the city , including 161 school classes and 3023 students are participating in the study .
-METHODS	Of those , 2801 students completed the baseline assessment .
-CONCLUSIONS	The present manuscript provides details on the study design and methodology of a large school-based smoking prevention trial in a metropolitan area in Germany .
-CONCLUSIONS	Findings from this study will yield important insight into the long-term effectiveness of specific smoking prevention strategies , also in disadvantaged population groups .
-BACKGROUND	NCT01306552 ( January 2011 ) .
-
-###25453528
-OBJECTIVE	Determining efficacy in complementary medicine research requires valid placebo/sham control groups that are credible to patients and ensure successful blinding .
-OBJECTIVE	Within the scope of this study , a light touch sham-control intervention for trials of Craniosacral Therapy ( CST ) was developed and tested for its credibility .
-METHODS	Patients of a randomized controlled trial on chronic non-specific neck pain ( NCT01526447 ) obtained the Credibility/Expectancy Questionnaire and the Helping Alliance/Satisfaction Questionnaire .
-METHODS	Treatment and sham group respectively received 8 weekly sessions of CST or light touch .
-METHODS	Data without ( N = 50 ) and with multiple imputation ( N = 54 ) were analyzed separately using logistic regression models .
-METHODS	Adjusted odds ratios ( AOR ) and 95 % confidence intervals ( CI ) were calculated to assess whether group outcome could be predicted from patients ' credibility ratings .
-METHODS	An additional t-test for analysis of the overall compliance/attendance was conducted .
-RESULTS	Patients ' ratings of treatment expectancy , credibility and therapeutic alliance were not found to have significant power for classifying patients into CST or sham group ( p. 05 ) .
-RESULTS	Only satisfaction with treatment revealed a significant impact ( AOR : 6.83 ; 95 % CI : [ 1.54 | 30.24 ] ; p = .011 ) in the non-imputed analysis , but not in the multiple imputation analysis ( AOR : 4.09 ; 95 % CI : [ 0.94 | 17.76 ] ; p = .060 ) .
-RESULTS	Compliance of both groups was not significantly different ( p > .05 ) as were reasons for non-attendance .
-RESULTS	No serious adverse events were reported .
-CONCLUSIONS	Patients ' expectancy , credibility and therapeutic alliance did not appear to affect study outcomes , blinding patients to group allocation was possible , and sham intervention was tolerable and safe .
-CONCLUSIONS	The design can therefore be recommended as control for non-specific treatment effects in future CST clinical trials .
-
-###24490380
-OBJECTIVE	to explore the clinical effect of LVD on patients with advanced schistosomiasis with chronic B hepatitis and on the course of disease development .
-METHODS	A total of 58 patients with advanced schistosomiasis with chronic B hepatitis were enrolled and randomly divided into the treatment group ( 30 cases ) and the control group ( 28 cases ) .
-METHODS	patients in the treatment group received routinet colligative treatment and LVD 100 mg daily , while patients in the control group received routinet colligative treatment only.All the patients were followed up for 36 + / - 3 months .
-RESULTS	The mortality rate was 13.33 % vs. 55.56 % in the treatment and control ( P < 0.01 ) .
-RESULTS	The patients whose Child-Pugh score decreased by more than 2 were 89.2 % vs. 62.3 % ( P < 0.05 ) .
-RESULTS	After treatment the serum ALT TBIL levels dropped , the serum albumin level increased and The improvement of liver function in the treatment group was better than that in the control group ( P < 0.01 ) .
-RESULTS	The HBeAg and HBV-DNA negutive rate in the treatment group were higher than those in the control ( P < 0.01 ) .
-RESULTS	The HBV-DNA negative rate in thetreatment group was 93.3 % at the end of 12 weekes .
-RESULTS	The rate of YMDD mutations was 6.7 % , 23.3 % and 40 % in the treatment group at the end of 48 , 96 and 144 weeks .
-RESULTS	LVD and ADV can inhibit virus replication and the relative stability liver function remained the same in most YMDD mutation patients .
-CONCLUSIONS	LVD can inhibit virus replication rapidly and improveliver function , prevent exacerbation in patients with advanced schistosomiasis with chronic B hepatitis , LVD and ADV can inhibit virus replication and improve liver function in most YMDD mutation patients .
-
-###25305223
-BACKGROUND	Multiple sclerosis ( MS ) is a chronic demyelinating disease of the central nervous system .
-BACKGROUND	Riboflavin is involved in myelin formation in nerve cells .
-BACKGROUND	Riboflavin is a precursor of flavin adenine D-nucleotide ( FAD ) , which is a coenzyme of methylene tetrahydrofolate reductase ( MTHFR ) , which is an important enzyme for remethylation of homocysteine .
-BACKGROUND	Riboflavin supplementation has been shown to affect the serum levels of homocysteine in healthy volunteers .
-BACKGROUND	The aim of the present study was to test the effect of riboflavin supplementation on the status and disability of patients with MS and whether this effect could be mediated by serum homocysteine levels .
-METHODS	This was a randomized , double-blind , controlled trial in which 29 MS patients with a mean age of 33 were tested with riboflavin , and the placebo group , with a mean age of 31 , received either riboflavin supplementation ( 10 mg ) or the placebo daily for six months .
-METHODS	Disability , measured by the Expanded Disability Status Scale ( EDSS ) scores , erythrocyte glutathione reductase activity coefficient ( EGRAC ) , and serum homocysteine levels were measured before and after the study .
-RESULTS	The mean SD of EDSS score was significantly decreased in both groups over the six months of the study ( 2.3 0.7 vs. 1.6 0.6 for the riboflavin group and 2.8 1.1 vs. 2.3 1.3 for the placebo groups .
-RESULTS	The comparison across both groups yielded a non-significant change ( P = 0.001 and 0.02 , respectively ) .
-RESULTS	No significant differences were observed between the two groups in terms of EGRAC , riboflavin deficiency levels by EGRAC category , and serum homocysteine levels before and after the study .
-CONCLUSIONS	Riboflavin supplementation ( 10 mg/day ) to patients with MS does not improve disability status .
-CONCLUSIONS	It appears that this effect is not related to serum homocysteine levels .
-
-###26115797
-BACKGROUND	The ICON7 trial previously reported improved progression-free survival in women with ovarian cancer with the addition of bevacizumab to standard chemotherapy , with the greatest effect in patients at high risk of disease progression .
-BACKGROUND	We report the final overall survival results of the trial .
-METHODS	ICON7 was an international , phase 3 , open-label , randomised trial undertaken at 263 centres in 11 countries across Europe , Canada , Australia and New Zealand .
-METHODS	Eligible adult women with newly diagnosed ovarian cancer that was either high-risk early-stage disease ( International Federation of Gynecology and Obstetrics [ FIGO ] stage I-IIa , grade 3 or clear cell histology ) or more advanced disease ( FIGO stage IIb-IV ) , with an Eastern Cooperative Oncology Group performance status of 0-2 , were enrolled and randomly assigned in a 1:1 ratio to standard chemotherapy ( six 3-weekly cycles of intravenous carboplatin [ AUC 5 or 6 ] and paclitaxel 175 mg/m ( 2 ) of body surface area ) or the same chemotherapy regimen plus bevacizumab 75 mg per kg bodyweight intravenously every 3 weeks , given concurrently and continued with up to 12 further 3-weekly cycles of maintenance therapy .
-METHODS	Randomisation was done by a minimisation algorithm stratified by FIGO stage , residual disease , interval between surgery and chemotherapy , and Gynecologic Cancer InterGroup group .
-METHODS	The primary endpoint was progression-free survival ; the study was also powered to detect a difference in overall survival .
-METHODS	Analysis was by intention to treat .
-METHODS	This trial is registered as an International Standard Randomised Controlled Trial , number ISRCTN91273375 .
-RESULTS	Between Dec 18 , 2006 , and Feb 16 , 2009 , 1528 women were enrolled and randomly assigned to receive chemotherapy ( n = 764 ) or chemotherapy plus bevacizumab ( n = 764 ) .
-RESULTS	Median follow-up at the end of the trial on March 31 , 2013 , was 489 months ( IQR 266-562 ) , at which point 714 patients had died ( 352 in the chemotherapy group and 362 in the bevacizumab group ) .
-RESULTS	Our results showed evidence of non-proportional hazards , so we used the difference in restricted mean survival time as the primary estimate of effect .
-RESULTS	No overall survival benefit of bevacizumab was recorded ( restricted mean survival time 446 months [ 95 % CI 432-459 ] in the standard chemotherapy group vs 455 months [ 442-467 ] in the bevacizumab group ; log-rank p = 085 ) .
-RESULTS	In an exploratory analysis of a predefined subgroup of 502 patients with poor prognosis disease , 332 ( 66 % ) died ( 174 in the standard chemotherapy group and 158 in the bevacizumab group ) , and a significant difference in overall survival was noted between women who received bevacizumab plus chemotherapy and those who received chemotherapy alone ( restricted mean survival time 345 months [ 95 % CI 320-370 ] with standard chemotherapy vs 393 months [ 370-417 ] with bevacizumab ; log-rank p = 003 ) .
-RESULTS	However , in non-high-risk patients , the restricted mean survival time did not differ significantly between the two treatment groups ( 497 months [ 95 % CI 483-511 ] ) in the standard chemotherapy group vs 484 months [ 470-499 ] in the bevacizumab group ; p = 020 ) .
-RESULTS	An updated analysis of progression-free survival showed no difference between treatment groups .
-RESULTS	During extended follow-up , one further treatment-related grade 3 event ( gastrointestinal fistula in a bevacizumab-treated patient ) , three grade 2 treatment-related events ( cardiac failure , sarcoidosis , and foot fracture , all in bevacizumab-treated patients ) , and one grade 1 treatment-related event ( vaginal haemorrhage , in a patient treated with standard chemotherapy ) were reported .
-CONCLUSIONS	Bevacizumab , added to platinum-based chemotherapy , did not increase overall survival in the study population as a whole .
-CONCLUSIONS	However , an overall survival benefit was recorded in poor-prognosis patients , which is concordant with the progression-free survival results from ICON7 and GOG-218 , and provides further evidence towards the optimum use of bevacizumab in the treatment of ovarian cancer .
-BACKGROUND	The National Institute for Health Research through the UK National Cancer Research Network , the Medical Research Council , and Roche .
-
-###25363178
-BACKGROUND	Renal stones are common disorders that affect approximately 5 % to 10 % of the population and the incidence of renal stones is rising .
-BACKGROUND	Treatment of ureteral stones is an important part of urologists and minimally invasive procedures such as ESWL and ureteroscopy effectiveness has been proven in various studies .
-BACKGROUND	However , these methods are not completely safe and are expensive and can be complicated .
-BACKGROUND	Purpose of this study is to evaluate the effectiveness of tamsulosin in the medical treatment of distal ureteral stones .
-METHODS	A total of 96 patients with distal ureteral stones or UVj are randomly divided into two study group ( 50 patients ) and control group ( 46 patients ) .
-METHODS	Patients in the control group allowed to freely consuming fluids ( hydration ) and indomethacin 100 mg PRN .
-METHODS	Study group in addition to indomethacin and daily analgesic 0.4 mg tamsulosin was administered .
-METHODS	All subjects in terms of analgesic dose , duration of expulsion and expulsion were studied .
-RESULTS	Spontaneous expulsion of stone was occurred in 62.5 % ( 30 patients out of 46 ) of control group patients and 82 % ( 41 patients out of 50 ) that there was no significant difference ( P > 0.05 ) .
-RESULTS	Average time to fix the stone in control group 4.7 8.03 days ( range 2 to 28 days ) and in the study group , 3.7 5.70 days ( range 1 to 23 days ) is significantly different ( P > 0.05 ) .
-RESULTS	The average amount of analgesic consumption in the control group was 2.3 4.31 and in the study group was 1.48 2.15 that showed significant differences ( P < 0.05 ) .
-CONCLUSIONS	In this study , although the addition of tamsulosin to conservative treatment of distal ureteral stones in the distal ureteral stone expulsion showed no significant difference between the two groups , but the reduction in the duration of expulsion , reduce pain and reduce the need for analgesic has been beneficial .
-
-###25885211
-BACKGROUND	Artemisinin-based combination therapy ( ACT ) following a confirmed parasitological diagnosis is recommended by the World Health Organization ( WHO ) and the Congolese National Malaria Control Program ( NMCP ) .
-BACKGROUND	However , commitment and competence of all stakeholders ( patients , medical professionals , governments and funders ) is required to achieve effective case management and secure the `` useful therapeutic life '' of the recommended drugs .
-BACKGROUND	The health seeking behaviour of patients and health care professionals ' practices for malaria management were assessed .
-METHODS	This was an observational study embedded in a two-stage cluster randomized survey conducted in one health centre ( HC ) in each of the 12 selected health zones in Kinshasa city .
-METHODS	All patients with clinical malaria diagnosis were eligible .
-METHODS	Their health seeking behaviour was recorded on a specific questionnaire , as well as the health care practitioners ' practices .
-METHODS	The last were not aware that their practices would be assessed .
-RESULTS	Six hundred and twenty four patients were assessed , of whom 136 ( 21.8 % ) were under five years .
-RESULTS	Three hundred and thirty five ( 55 % ) had taken medication prior to the current consultation ( self - medication with any product or visiting another HC ) of whom 47 ( 14 % ) took an antimalarial drug , and 56 ( 9 % ) were treated presumptively .
-RESULTS	Among those , 53.6 % received monotherapy either with quinine , artesunate , phytomedicines , sulfadoxine-pyrimethamine or amodiaquine .
-RESULTS	On the other side , when clinicians were informed about laboratory results , monotherapy was prescribed in 39.9 % of the confirmed malaria cases .
-RESULTS	Only 285 patients ( 45.7 % ) were managed in line with WHO and NMCP guidelines , of whom 120 ( 19.2 % ) were prescribed an ACT after positive blood smear and 165 ( 26.4 % ) received no antimalarial after a negative result .
-CONCLUSIONS	This study shows the discrepancy between malaria policies and the reality on the field in Kinshasa , regarding patients ' health seeking behaviour and health professionals ' practices .
-CONCLUSIONS	Consequently , the poor compliance to the policies may contribute to the genesis and spread of antimalarial drug resistance and also have a negative impact on the burden of the disease .
-
-###24609847
-BACKGROUND	Chinese Americans are at increased risk for hepatitis B virus ( HBV ) infection .
-BACKGROUND	To reduce or eliminate disparities in HBV-related infection rates , participation in scientific investigations of HBV risk and treatment , including biospecimen sampling , is important .
-BACKGROUND	However , Asian Americans have low rates of participation in biospecimen research , and little is known about how educational interventions affect knowledge and participation in HBV-related biospecimen research .
-METHODS	Eight Chinese community-based organizations participated in a quasi-experimental , two-group design with education assessments at pre - and postworkshop and a 3-month follow-up .
-METHODS	Four sites were randomly assigned to receive the intervention ( n = 175 ) and four sites to receive general health education ( control ; n = 240 ) .
-RESULTS	Participant knowledge about biospecimen research increased from pre - to posteducation in the intervention but not in the control condition .
-RESULTS	Of intervention participants , 83.4 % ( 146/175 ) donated one tube of blood for future HBV biospecimen research , and 50.9 % ( 89/175 ) donated another tube of blood for HBV testing .
-RESULTS	In contrast , only 1.1 % of participants in the control condition reported donating a blood sample at follow-up assessment .
-CONCLUSIONS	The intervention program significantly increased knowledge of and participation in HBV biospecimen research among Chinese Americans .
-CONCLUSIONS	Community-based participatory research ( CBPR ) methods featured active support by community leaders , a culturally specific curriculum , and convenient , immediate access to blood sampling , which resulted in high donation rates .
-CONCLUSIONS	HBV-related morbidity and mortality is an urgent problem faced by Chinese Americans .
-CONCLUSIONS	CBPR provides a model for engaging communities in early detection , vaccination , and treatment that can reduce this health threat .
-
-###24423012
-BACKGROUND	Bronchospasm results in airway obstruction in horses with heaves .
-BACKGROUND	Atropine is the most potent bronchodilator drug currently available for horses , but is associated with side effects that limit its use .
-BACKGROUND	Like atropine , N-butylscopolammonium bromide ( NBB ) is an anticholinergic agent with bronchodilatory properties .
-OBJECTIVE	To compare the bronchodilating effects and side effects of atropine and NBB in horses with heaves .
-METHODS	Cross-over experiment using horses with heaves .
-METHODS	Eight horses with heaves were administered atropine and NBB , using a cross-over design .
-METHODS	Heart rate , pupillary dilatation , transrectal palpation , lung mechanics ( maximal changes in transpulmonary pressure , pulmonary resistance and elastance ) and arterial blood gases were assessed before and 10 and 30min after drug administration .
-RESULTS	One horse treated with atropine developed colic .
-RESULTS	Significant pupillary dilatation was observed only with atropine .
-RESULTS	Tachycardia developed in all horses , but was more marked with atropine .
-RESULTS	Lung function improved with both drugs , but elastance values had returned to baseline at 30min with NBB .
-RESULTS	There was no improvement in arterial hypoxaemia with either drug .
-CONCLUSIONS	The study indicated that the bronchodilatory properties of NBB were not statistically different from those of atropine , but were of shorter duration .
-CONCLUSIONS	N-butylscopolammonium bromide was associated with fewer systemic side effects , and therefore NBB should be preferred over atropine when assessing the reversibility of airway obstruction in horses .
-
-###25442646
-OBJECTIVE	To assess driving ability ( brake response time [ BRT ] ) with commonly used knee braces .
-METHODS	Sixty-four healthy participants ( 32 women and 32 men ) participated in our study .
-METHODS	BRT was assessed using a custom-made driving simulator .
-METHODS	We assessed BRT for 5 different commonly used knee braces ( right leg ) used in 9 different settings : without a knee brace ( control group ) ; with a typical postoperative knee brace with adjustable range of motion ( ROM ) and the settings of 0 to 30 , 0 to 60 , 0 to 90 , and 20 to 90 ( extension and flexion ) ; and with an unloading knee brace for moderate to severe unicompartmental osteoarthritis , an orthosis for ligament instabilities , a knee brace for patellofemoral disorders , and an elastic knee bandage .
-RESULTS	The 64 participants ( mean age , 33.5 years ) showed significantly impaired BRT with the typical postoperative brace set at an ROM of 0 to 30 ( 673 milliseconds , P < .001 ) , ROM of 0 to 60 ( 629 milliseconds , P < .001 ) , ROM of 0 to 90 ( 607 milliseconds , P = .001 ) , and ROM of 20 to 90 ( 602 milliseconds , P = .005 ) compared with the control group .
-RESULTS	However , no such impaired BRT was found for any other investigated knee brace .
-CONCLUSIONS	Right-sided ROM-restricting knee braces involve significant impairment of BRT in healthy participants .
-CONCLUSIONS	No such prolonged BRT was found for a patellofemoral realignment brace , a ligament brace , a valgus/osteoarthritis brace , or an elastic knee bandage .
-CONCLUSIONS	However , our findings should be viewed in light of the limitations of the study , which are ( 1 ) the lack of a defined decrease in BRT that could lead to an accident and ( 2 ) uncertainty of whether the statistical differences are also clinically important .
-METHODS	Level II , lesser-quality randomized controlled trial .
-
-###25410510
-BACKGROUND	We previously demonstrated the feasibility and clinical effectiveness of a web-based assessment following total hip or total knee arthroplasty .
-BACKGROUND	The purpose of the present study was to conduct an economic evaluation to compare a web-based assessment with in-person follow-up .
-METHODS	Patients who had undergone total joint arthroplasty at least twelve months previously were randomized to complete a web-based follow-up or visit the clinic for the usual follow-up .
-METHODS	We recorded travel costs and time associated with each option .
-METHODS	We followed patients for one year after the web-based or in-person follow-up evaluation and documented any resource use related to the joint arthroplasty .
-METHODS	We conducted cost analyses from the health-care payer ( Ontario Ministry of Health and Long-Term Care ) and societal perspectives .
-METHODS	All costs are presented in 2012 Canadian dollars .
-RESULTS	A total of 229 patients ( 118 in the web-based group , 111 in the usual-care group ) completed the study .
-RESULTS	The mean cost of the assessment from the societal perspective was $ 98 per patient for the web-based assessment and $ 162 per patient for the usual method of in-person follow-up .
-RESULTS	The cost for the web-based assessment was significantly lower from the societal perspective ( mean difference , $ -64 ; 95 % confidence interval [ CI ] , $ -79 to $ -48 ; p < 0.01 ) and also from the health-care payer perspective ( mean difference , $ -27 ; 95 % CI , $ -29 to $ -25 ; p < 0.01 ) .
-CONCLUSIONS	The web-based follow-up assessment had a lower cost per patient compared with in-person follow-up from both societal and health-care payer perspectives .
-
-###24889794
-BACKGROUND	Despite aggressive local therapy , patients with locally advanced bladder cancer have a significant risk of distant metastases .
-BACKGROUND	This study evaluated the role of neoadjuvant combination chemotherapy with gemcitabine/cisplatin ( GC ) in improving the outcome of this group of patients over radical cystectomy alone .
-METHODS	A total of 114 patients with newly diagnosed bladder cancer ( T3-4 , N0-2 , M0 ) were randomized to radical cystectomy alone or initial 3 cycles of GC , then managed according to response .
-METHODS	Patients who achieved complete response completed 6 cycles of GC followed by local radiation therapy ( RT ) only .
-METHODS	If tumors were downstaged to T1 , complete transurethral resection was done , followed by 3 cycles of GC and then RT. .
-METHODS	Patients with partial response underwent radical cystectomy followed by 3 cycles of GC .
-METHODS	Patients with stable disease or disease progression underwent radical cystectomy .
-RESULTS	The overall response rate to GC was 55.1 % , and complete response was achieved in 28.6 % .
-RESULTS	The 3-year overall survival ( OS ) was 51.9 % versus 51.2 % in the chemotherapy and surgery arms , respectively ( P = .399 ) .
-RESULTS	The 3-year disease-free survival was 31.8 % in the chemotherapy arm and 45.1 % in the surgery arm ( P = .06 ) .
-RESULTS	Bladder preservation was achieved in 22.5 % of patients in the neoadjuvant arm .
-RESULTS	OS was 78 % in responding patients and 100 % in patients with complete response .
-CONCLUSIONS	Neoadjuvant GC did not improve survival in locally advanced bladder cancer over radical cystectomy alone .
-CONCLUSIONS	However , bladder preservation was feasible , and OS in responding patients was impressive .
-CONCLUSIONS	Therefore , predictive models to select patients are needed .
-CONCLUSIONS	This is the largest prospective study of squamous cell carcinoma and transitional cell carcinoma using neoadjuvant GC .
-
-###25187257
-BACKGROUND	Fragile X syndrome ( FXS ) is an inherited neurodevelopmental condition characterised by behavioural , learning disabilities , physical and neurological symptoms .
-BACKGROUND	In addition , an important degree of comorbidity with autism is also present .
-BACKGROUND	Considered a rare disorder affecting both genders , it first becomes apparent during childhood with displays of language delay and behavioural symptoms.Main aim : To show whether the combination of 10 mg/kg/day of ascorbic acid ( vitamin C ) and 10 mg/kg/day of - tocopherol ( vitamin E ) reduces FXS symptoms among male patients ages 6 to 18 years compared to placebo treatment , as measured on the standardized rating scales at baseline , and after 12 and 24 weeks of treatment.Secondary aims : To assess the safety of the treatment .
-BACKGROUND	To describe behavioural and cognitive changes revealed by the Developmental Behaviour Checklist Short Form ( DBC-P24 ) and the Wechsler Intelligence Scale for Children-Revised .
-BACKGROUND	To describe metabolic changes revealed by blood analysis .
-BACKGROUND	To measure treatment impact at home and in an academic environment .
-METHODS	A phase II randomized , double-blind pilot clinical trial .
-METHODS	male children and adolescents diagnosed with FXS , in accordance with a standardized molecular biology test , who met all the inclusion criteria and none of the exclusion criteria .
-METHODS	clinical data , blood analysis , Wechsler Intelligence Scale for Children-Revised , Conners parent and teacher rating scale scores and the DBC-P24 results will be obtained at the baseline ( t0 ) .
-METHODS	Follow up examinations will take place at 12 weeks ( t1 ) and 24 weeks ( t2 ) of treatment .
-CONCLUSIONS	A limited number of clinical trials have been carried out on children with FXS , but more are necessary as current treatment possibilities are insufficient and often provoke side effects .
-CONCLUSIONS	In the present study , we sought to overcome possible methodological problems by conducting a phase II pilot study in order to calculate the relevant statistical parameters and determine the safety of the proposed treatment .
-CONCLUSIONS	The results will provide evidence to improve hyperactivity control and reduce behavioural and learning problems using ascorbic acid ( vitamin C ) and - tocopherol ( vitamin E ) .
-CONCLUSIONS	The study protocol was approved by the Regional Government Committee for Clinical Trials in Andalusia and the Spanish agency for drugs and health products .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT01329770 ( 29 March 2011 ) .
-
-###26156512
-OBJECTIVE	To investigate the effect of regular aerobic training and postexercise protein-carbohydrate supplementation in patients with facioscapulohumeral muscular dystrophy ( FSHD ) .
-METHODS	In this randomized , double-blind , placebo-controlled parallel study , we randomized untrained men ( n = 21 ) and women ( n = 20 ) with FSHD ( age 19-65 years ) to 2 training groups-training with protein supplement ( n = 18 ) and training with placebo supplement ( n = 13 ) - and a nonintervention control group ( n = 10 ) .
-METHODS	We assessed fitness , walking speed , muscle strength , questionnaires , and daily activity levels before and after 12 weeks of interventions .
-METHODS	Training involved 36 sessions of 30-minute cycle-ergometer training .
-METHODS	After each session , patients drank either a protein-carbohydrate or placebo beverage .
-RESULTS	In the trained participants , fitness , workload , and walking speed improved ( 10 % [ confidence interval ( CI ) 4 % -15 % ] , 18 % [ CI 10 % -26 % ] , 7 % [ CI 4 % -11 % ] , respectively , p < 0.001 , number needed to treat = 2.1 ) .
-RESULTS	Self-assessed physical capacity and health ( Short Form-36 ) also improved .
-RESULTS	Muscle strength and daily activity levels did not change with training .
-RESULTS	Protein-carbohydrate supplementation did not result in further improvements in any tests compared to training alone .
-CONCLUSIONS	This randomized , controlled study showed that regular endurance training improves fitness , walking speed , and self-assessed health in patients with FSHD without causing muscle damage .
-CONCLUSIONS	Postexercise protein-carbohydrate supplementation does not add any further improvement to training effects alone .
-METHODS	This study provides Class II evidence that regular aerobic training with or without postexercise protein-carbohydrate supplementation improves fitness and workload in patients with FSHD .
-
-###24622750
-BACKGROUND	Iodine deficiency in infants can damage the developing brain and increase mortality .
-BACKGROUND	Present recommendations state that oral iodised oil should be given to breastfeeding mothers to correct iodine deficiency in infancy when iodised salt is not available , and that direct supplementation should be given to infants who are not being breastfed or receiving iodine-fortified complimentary foods .
-BACKGROUND	However , there is little evidence for these recommendations .
-BACKGROUND	We aimed to assess the safety and efficacy of direct versus indirect supplementation of the infant .
-METHODS	We did this double blind , randomised , placebo-controlled trial in Morocco .
-METHODS	Healthy breastfeeding mothers and their term newborn babies ( aged 8 weeks ) were block randomised by clinic day to receive either : one dose of 400 mg iodine to the mother and placebo to the infant ( indirect infant supplementation ) , or one dose of about 100 mg iodine to the infant and placebo to the mother ( direct infant supplementation ) .
-METHODS	Randomisation was masked to participants and investigators .
-METHODS	Coprimary outcomes were : maternal and infant urinary iodine concentrations , breastmilk iodine concentration , maternal and infant thyroid-stimulating hormone ( TSH ) concentrations , maternal and infant thyroxine ( T4 ) concentrations , and infant growth .
-METHODS	These outcomes were measured at baseline , and when infants were aged about 3 months , 6 months , and 9 months , and the two groups were compared using mixed effects models .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01126125 .
-RESULTS	We recruited 241 mother-infant pairs between Feb 25 , and Aug 10 , 2010 , and completed data collection by Aug 6 , 2011 .
-RESULTS	At baseline , median urinary iodine concentration was 35 g/L ( IQR 29-40 ) in mothers and 73 g/L ( 29-237 ) in infants , suggesting iodine deficiency .
-RESULTS	During the study , maternal urinary iodine concentration ( p = 0.011 ) , breastmilk iodine concentration ( p < 0.0001 ) , and infant urinary iodine concentration ( p = 0.042 ) were higher in the indirect infant supplementation group than in the direct supplementation group .
-RESULTS	Maternal TSH ( p = 0.276 ) and T4 ( p = 0.074 ) concentrations did not differ between the groups over the course of the study , nor did infant TSH ( p = 0.597 ) and T4 ( p = 0.184 ) concentrations , but the number of infants with thyroid hypofunction was lower ( p = 0.023 ) in the indirect supplementation group than the direct supplementation group .
-RESULTS	The infant groups did not differ in anthropomorphic measures , except that length-for-age Z score was slightly greater in the direct infant supplementation group ( p = 0.032 ) .
-RESULTS	At 3 months and 6 months of age , median infant urinary iodine concentration in the indirect infant supplementation group was sufficient ( > 100 g/L ) , whereas infant urinary iodine concentration was sufficient only at 6 months in the direct supplementation group .
-RESULTS	There were no serious adverse events in either group .
-CONCLUSIONS	In regions of moderate-to-severe iodine deficiency without effective salt iodisation , lactating women who receive one dose of 400 mg iodine as oral iodised oil soon after delivery can provide adequate iodine to their infants through breastmilk for at least 6 months , enabling the infants to achieve euthyroidism .
-CONCLUSIONS	Direct supplementation is less effective in improving infant iodine status .
-BACKGROUND	ETH Zurich , Switzerland ; the Medicor Foundation , Vaduz , Lichtenstein .
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-###24556098
-OBJECTIVE	The intention of the PEPCAD China ISR ( A Prospective , Multicenter , Randomized Trial of Paclitaxel-Coated versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis ) was to demonstrate the efficacy of paclitaxel-coated balloon ( PCB ) angioplasty in a non-European patient population with coronary drug-eluting stent in-stent restenosis ( DES-ISR ) .
-BACKGROUND	The treatment of DES-ISR is still challenging with no established best strategy .
-BACKGROUND	Moreover , there is no study on the effect of PCB in the treatment of ISR in the Chinese population .
-METHODS	PEPCAD China ISR was a 220-patient randomized ( 1:1 ) , single-blind prospective multicenter trial conducted in China .
-METHODS	Patients with coronary DES-ISR received either PCB ( SeQuent Please , B. Braun Melsungen AG , Melsungen , Germany ) or paclitaxel-eluting stent ( Taxus Libert , Boston Scientific , Natick , Massachusetts ) treatment .
-METHODS	The primary endpoint was in-segment late lumen loss at 9 months .
-RESULTS	There were no significant baseline differences between both treatment groups in terms of patient , lesion , or procedural characteristics .
-RESULTS	At 9 months , in-segment late lumen loss in the PCB group was noninferior to that of the paclitaxel-eluting stent group ( 0.46 0.51 mm vs. 0.55 0.61 mm ; difference : -0.06 mm with 95 % confidence interval : -0.23 to 0.10 ; p for noninferiority = 0.0005 ) .
-RESULTS	The 9-month rate of binary restenosis and 12-month composite clinical event rates were not significantly different between groups .
-CONCLUSIONS	In a randomized trial of 220 patients , angioplasty with a PCB was noninferior to paclitaxel-eluting stent implantation when used to treat DES-ISR .
-CONCLUSIONS	On the basis of these , as well as previous randomized trial data , PCB angioplasty offers an effective treatment for DES-ISR without the necessity of implanting additional metal layers for drug release .
-CONCLUSIONS	( A Safety and Efficacy Study of Paclitaxel-Eluting Balloon to Paclitaxel-Eluting Stent [ PEPCAD ] ; NCT01622075 ) .
-
-###24811969
-BACKGROUND	Four-factor prothrombin complex concentrates ( PCCs ) , which contain factorII , FVII , FIX , and FX , have shown the potential to reverse the anticoagulant effect of rivaroxaban in healthy volunteers .
-BACKGROUND	The purpose of this study was to determine whether a three-factor PCC , which contains little FVII , has a similar effect .
-RESULTS	We performed an open-label , single-center , parallel-group study comparing the effect of a three-factor PCC ( ProfilnineSD ) with that of a four-factor PCC ( BeriplexP/N ) on the pharmacodynamics of rivaroxaban in 35 healthy volunteers .
-RESULTS	After receiving 4days of rivaroxaban 20mg twice daily to obtain supratherapeutic steady-state concentrations , volunteers were randomized to receive a single 50IUkg ( -1 ) bolus dose of four-factor PCC , three-factor PCC or saline 4h after the morning dose of rivaroxaban on day5 , and the effects of these interventions on prothrombin time and thrombin generation were determined .
-RESULTS	Within 30min , four-factor PCC reduced mean prothrombin time by 2.5-3 .5 s , whereas three-factor PCC produced only a 0.6-1 .0 - s reduction .
-RESULTS	In contrast , three-factor PCC reversed rivaroxaban-induced changes in thrombin generation more than four-factor PCC .
-CONCLUSIONS	This study demonstrates the potential of both three-factor and four-factor PCCs to at least partially reverse the anticoagulant effects of rivaroxaban in healthy adults .
-CONCLUSIONS	The discrepant effects of the PCC preparations may reflect differences in the procoagulant components present in each .
-
-###24391123
-BACKGROUND	Dental care is a significant unmet health care need for children with autism spectrum disorders ( ASD ) .
-BACKGROUND	Many children with ASD do not receive dental care because of fear associated with dental procedures ; oftentimes they require general anesthesia for regular dental procedures , placing them at risk of associated complications .
-BACKGROUND	Many children with ASD have a strong preference for visual stimuli , particularly electronic screen media .
-BACKGROUND	The use of visual teaching materials is a fundamental principle in designing educational programs for children with ASD .
-OBJECTIVE	To determine if an innovative strategy using 2 types of electronic screen media was feasible and beneficial in reducing fear and uncooperative behaviors in children with ASD undergoing dental visits .
-METHODS	We conducted a randomized controlled trial at Boston Children 's Hospital dental clinic .
-METHODS	Eighty ( 80 ) children aged 7 to 17 years with a known diagnosis of ASD and history of dental fear were enrolled in the study .
-METHODS	Each child completed 2 preventive dental visits that were scheduled 6 months apart ( visit 1 and visit 2 ) .
-METHODS	After visit 1 , subjects were randomly assigned to 1 of 4 groups : ( 1 ) group A , control ( usual care ) ; ( 2 ) group B , treatment ( video peer modeling that involved watching a DVD recording of a typically developing child undergoing a dental visit ) ; ( 3 ) group C , treatment ( video goggles that involved watching a favorite movie during the dental visit using sunglass-style video eyewear ) ; and ( 4 ) group D , treatment ( video peer modeling plus video goggles ) .
-METHODS	Subjects who refused or were unable to wear the goggles watched the movie using a handheld portable DVD player .
-METHODS	During both visits , the subject 's level of anxiety and behavior were measured using the Venham Anxiety and Behavior Scales .
-METHODS	Analyses of variance and Fisher 's exact tests compared baseline characteristics across groups .
-METHODS	Using intention to treat approach , repeated measures analyses were employed to test whether the outcomes differed significantly : ( 1 ) between visits 1 and 2 within each group and ( 2 ) between each intervention group and the control group over time ( an interaction ) .
-RESULTS	Between visits 1 and 2 , mean anxiety and behavior scores decreased significantly by 0.8 points ( P = .03 ) for subjects within groups C and D. Significant changes were not observed within groups A and B. Mean anxiety and behavior scores did not differ significantly between groups over time , although group A versus C pairwise comparisons showed a trend toward significance ( P = .06 ) .
-CONCLUSIONS	These findings suggest that certain electronic screen media technologies may be useful tools for reducing fear and uncooperative behaviors among children with ASD undergoing dental visits .
-CONCLUSIONS	Further studies are needed to assess the efficacy of these strategies using larger sample sizes .
-CONCLUSIONS	Findings from future studies could be relevant for nondental providers who care for children with ASD in other medical settings .
-
-###25262324
-BACKGROUND	Increasing chest compression rate during cardiopulmonary resuscitation can affect the workload and , ultimately , the quality of chest compression .
-BACKGROUND	This study examines the effects of compression at the rate of as-fast-as-you-can on cardiopulmonary resuscitation ( CPR ) performance .
-METHODS	A crossover , randomized-to-order design was used .
-METHODS	Each participant performed chest compressions without ventilation on a manikin with 2 compression rates : 100 per minute ( 100-cpm ) and `` push as-fast-as you-can '' ( PF ) .
-METHODS	The participants performed chest compressions at a rate of either 100-cpm or PF and subsequently switched to the other after a 50-minute rest .
-RESULTS	Forty-two CPR-qualified nonprofessionals voluntarily participated in the study .
-RESULTS	During the PF session , the rescuers performed CPR with higher compression rates ( 156.8 vs 101.6 cpm ) , more compressions ( 787.2 vs 510.8 per 5 minutes ) , and more duty cycles ( 51.0 % vs 41.7 % ) , but a lower percentage of effective compressions ( 47.7 % vs 57.9 % ) and a lower compression depth ( 35.6 vs 38.0 mm ) than they did during the 100-cpm session .
-RESULTS	The CPR quality deteriorated in numbers and percentile of effective compression since the third minute in the PF session and the fourth minute in the 100-cpm session .
-RESULTS	The percentile of compressions with adequate depth in the 100-cpm sessions was higher than that in the PF sessions during the second , third , and fourth minutes of CPR .
-CONCLUSIONS	Push-fast technique showed a significant decrease in the percentile of effective chest compression compared with the 100-cpm technique during the 5-minute hand-only CPR .
-CONCLUSIONS	The PF technique exhibited a trend toward increased fatigue in the rescuers , which can result in early decay of CPR quality .
-
-###24289181
-BACKGROUND	Long-term management of chronic conditions , such as atrial fibrillation ( AF ) , require frequent interactions with the healthcare systems .
-BACKGROUND	The multinational EUropean Patient Survey in Atrial Fibrillation ( EUPS-AF ) was conducted to investigate patient satisfaction with AF management in different of five European healthcare systems at a time of changing treatment paradigms for stroke prophylaxis , prior to the advent of newer oral anticoagulants .
-METHODS	Adults ( > 18 years ) were recruited at random from the total populations of France , Germany , Italy , Spain and the UK using a randomized telephone dialling system .
-METHODS	At least 300 respondents per country reporting to have a diagnosis of AF or receiving oral anticoagulation therapy for suspected AF or to have a heart rhythm disturbance completed a structured telephone interview .
-RESULTS	Most respondents were satisfied with their treatment for AF over the previous 12 months , with 85.5 % ( n = 1289 ) rating their care as good or better .
-RESULTS	Suboptimal clinical practices , however , were identified in several key areas .
-RESULTS	Coordination of primary and secondary care and a lack of patient engagement and support were particular issues , especially for those patients likely to have extensive contact with their healthcare system .
-CONCLUSIONS	In the context of Europe-wide guidelines for management of AF , most patients with AF were satisfied with their care , but for a greater proportion of patients , some aspects are unsatisfactory .
-CONCLUSIONS	Patient-centred surveys , such as the EUPS-AF , are crucial for understanding the factors that contribute to patient satisfaction and compliance with long-term treatment for chronic conditions .
-
-###24708660
-BACKGROUND	Isovolemic anemia ( decrease in hemoglobin concentration with normal or even increased blood volume ) after gastric cancer surgery may negatively influence short - and long-term outcomes .
-BACKGROUND	Therefore correction of isovolemic postoperative anemia is supposed to be beneficial .
-BACKGROUND	This prospective randomized placebo-controlled multicenter trial is designed to evaluate the efficacy of ferric carboxymaltose administration with the primary end point of successful hemoglobin level increase by 2 g/dl at 12 weeks after randomization .
-METHODS	Gastric cancer patients after oncologic resection and postoperative hemoglobin level7 g/dl to < 10 g/dl at postoperative days 5 to 7 will be eligible for trial inclusion .
-METHODS	After randomization , 450 patients ( 225 per group ) are going to be subjected either to administration of ferric carboxymaltose ( treatment group ) or normal ( 0.9 % ) saline ( placebo group ) .
-METHODS	Patients will be blinded to the intervention .
-METHODS	Patients will undergo evaluation for hemoglobin level , hematology and quality of life assessment 3 and 12 weeks after randomization .
-CONCLUSIONS	Correction of isovolemic postoperative anemia in gastric cancer patients after oncologic resection is considered to be beneficial .
-CONCLUSIONS	Administration of ferric carboxymaltose is considered to be superior to placebo for anemia correction without the possible risks of red blood cell transfusion .
-CONCLUSIONS	Further , improved quality of life for patients with quick recovery of hemoglobin levels is expected .
-BACKGROUND	NCT01725789 ( international : http://www.clinicaltrials.gov ) and NCCCTS-12-644 ( NCC , Korea ) .
-
-###24512496
-BACKGROUND	Hyperandrogenism and inflammation are related in polycystic ovary syndrome ( PCOS ) .
-BACKGROUND	Hyperandrogenemia can induce inflammation in reproductive-age women , but the mechanism for this phenomenon is unclear .
-OBJECTIVE	We examined the in vivo and in vitro effects of hyperandrogenism on mononuclear cell ( MNC ) - derived androgen receptor ( AR ) status and TNF release .
-METHODS	This study combined a randomized , controlled , double-blind protocol with laboratory-based cell culture experiments .
-METHODS	This work was performed in an academic medical center .
-METHODS	Lean , healthy , reproductive-age women were treated with 130 mg of dehydroepiandrosterone ( DHEA ) or placebo ( n = 8 subjects each ) for 5 days and also provided untreated fasting blood samples ( n = 12 subjects ) for cell culture experiments .
-METHODS	AR mRNA content and TNF release were measured before and after DHEA administration in the fasting state and 2 hours after glucose ingestion .
-METHODS	TNF release in the fasting state was also measured in cultured MNCs exposed to androgens with or without flutamide preincubation .
-RESULTS	At baseline , subjects receiving DHEA or placebo exhibited no significant difference in androgens and TNF release from MNCs before and after glucose ingestion .
-RESULTS	Compared with placebo , DHEA administration raised levels of T , androstenedione , and DHEA sulfate , and increased MNC-derived AR mRNA content and TNF release in the fasting state and in response to glucose ingestion .
-RESULTS	Compared with MNC exposure to baseline concentrations of DHEA ( 175 ng/dL ) or T ( 50 ng/dL ) , the absolute change in TNF release increased after exposure to T concentrations of 125 and 250 ng/dL and a DHEA concentration of 1750 ng/dL .
-RESULTS	Preincubation with flutamide reduced the TNF response by 60 % across all T concentrations .
-CONCLUSIONS	Androgen excess in vivo and in vitro comparable to what is present in PCOS increases TNF release from MNCs of lean healthy reproductive-age women in a receptor-dependent fashion .
-CONCLUSIONS	Hyperandrogenemia activates and sensitizes MNCs to glucose in this population .
-
-###25472980
-BACKGROUND	Drug-coated balloons ( DCBs ) have shown promise in improving the outcomes for patients with peripheral artery disease .
-BACKGROUND	We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty ( PTA ) for the treatment of symptomatic superficial femoral and popliteal artery disease .
-RESULTS	The IN.PACT SFA Trial is a prospective , multicenter , single-blinded , randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA .
-RESULTS	The primary efficacy end point was primary patency , defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months .
-RESULTS	Baseline characteristics were similar between the 2 groups .
-RESULTS	Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94 4.89 and 8.81 5.12 cm ( P = 0.82 ) and 25.8 % and 19.5 % ( P = 0.22 ) , respectively .
-RESULTS	DCB resulted in higher primary patency versus PTA ( 82.2 % versus 52.4 % ; P < 0.001 ) .
-RESULTS	The rate of clinically driven target lesion revascularization was 2.4 % in the DCB arm in comparison with 20.6 % in the PTA arm ( P < 0.001 ) .
-RESULTS	There was a low rate of vessel thrombosis in both arms ( 1.4 % after DCB and 3.7 % after PTA [ P = 0.10 ] ) .
-RESULTS	There were no device - or procedure-related deaths and no major amputations .
-CONCLUSIONS	In this prospective , multicenter , randomized trial , DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique Identifiers : NCT01175850 and NCT01566461 .
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-###24565122
-OBJECTIVE	We investigated the effect of Nitrous Oxide ( N2O ) on controlled hypotension in low-flow isoflurane-dexmedetomidine anesthesia in terms of hemodynamics , anesthetic consumption , and costs .
-METHODS	We allocated forty patients randomly into two equal groups .
-METHODS	We then maintained dexmedetomidine infusion ( 0.1 g.kg-1 .
-METHODS	min-1 ) for 10 minutes .
-METHODS	Next , we continued it until the last 30 minutes of the operation at a dose of 0.7 g.kg ( -1 ) .
-METHODS	hour ( -1 ) .
-METHODS	We administered thiopental ( 4-6 mg .
-METHODS	kg ( -1 ) ) and 0.08-0 .12 mg.kg ( -1 ) vecuronium bromide at induction for both groups .
-METHODS	We used isoflurane ( 2 % ) for anesthesia maintenance .
-METHODS	Group N received a 50 % O2-N2O mixture and Group A received 50 % O - air mixture as carrier gas .
-METHODS	We started low-flow anesthesia ( 1 L.min ( -1 ) ) after a 10-minute period of initial high flow ( 4.4 L.min ( -1 ) ) .
-METHODS	We recorded values for blood pressure , heart rate , peripheral O2 saturation , inspiratory isoflurane , expiratory isoflurane , inspiratory O2 , expiratory O2 , inspiratory N2O , expiratory N2O , inspiratory CO2 , CO2 concentration after expiration , Minimum Alveolar Concentration .
-METHODS	In addition , we determined the total consumption rate of fentanyl , dexmedetomidine and isoflurane as well as bleeding .
-RESULTS	In each group the heart rate decreased after dexmedetomidine loading .
-RESULTS	After intubation , values were higher for Group A at one , three , five , 10 , and 15 minutes .
-RESULTS	After intubation , the patients reached desired hypotension values at minute five for Group N and at minute 20 for group A. MAC values were higher for Group N at minute one , three , five , 10 , and 15 ( p < 0.05 ) .
-RESULTS	FiO2 values were high between minute five and 60 for Group A , while at minute 90 Group N values were higher ( p < 0.05 ) .
-RESULTS	Fi Iso ( inspiratuvar isofluran ) values were lower in Group N at minute 15 and 30 ( p < 0.05 ) .
-CONCLUSIONS	By using dexmedetomidine instead of nitrous oxide in low flow isoflurane anesthesia , we attained desired MAP levels , sufficient anesthesia depth , hemodynamic stability and safe inspiration parameters .
-CONCLUSIONS	Dexmedetomidine infusion with medical air-oxygen as a carrier gas represents an alternative anesthetic technique .
-
-###25701101
-OBJECTIVE	To examine whether self-efficacy mediated the effect of the Home-based Post-Hip Fracture Rehabilitation program on activity limitations in older adults after hip fracture and whether the mediating effect was different between sex and age groups .
-METHODS	Randomized controlled trial .
-METHODS	Community .
-METHODS	Participants with hip fracture ( N = 232 ; mean age SD , 799.4 y ) were randomly assigned to intervention ( n = 120 , 51.7 % ) and attention control ( n = 112 , 48.3 % ) groups .
-METHODS	The 6-month intervention , the Home-based Post-Hip Fracture Rehabilitation , is a functionally oriented , home-based exercise program .
-METHODS	Data were collected at baseline , postintervention ( 6mo ) , and follow-up ( 9mo ) .
-METHODS	Activity Measure for Post-Acute Care .
-RESULTS	The mediating effect of the Home-based Post-Hip Fracture Rehabilitation program on Basic Mobility function through self-efficacy for exercise was significant at 9 months ( indirect = .21 ) .
-RESULTS	Similarly , the mediating effect of the intervention on Daily Activity function through self-efficacy for exercise was significant at 9 months ( indirect = .49 ) .
-RESULTS	In subgroup analyses , the mediating effect was significant at 9 months in the younger group ( age , 79y ) in comparison to the older group and was significant in women in comparison to men .
-CONCLUSIONS	Self-efficacy may play a partial mediating role in the effect on some longer-term functional outcomes in the Home-based Post-Hip Fracture Rehabilitation intervention .
-CONCLUSIONS	The results suggest that program components that target self-efficacy should be incorporated in future hip fracture rehabilitation interventions .
-CONCLUSIONS	Age and sex of the targeted participants may also need to be considered when developing interventions .
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-###24995515
-OBJECTIVE	Albinterferon is a fusion of albumin and interferon-2b developed to improve the pharmacokinetics , convenience , and potential efficacy of interferon - for the treatment of chronic hepatitis infections .
-METHODS	This open-label , randomized , active-controlled , multicenter study investigated the safety and efficacy of albinterferon in patients with chronic hepatitis B virus ( HBV ) infection who were e-antigen ( HBeAg ) positive .
-METHODS	One hundred and forty-one patients received one of four albinterferon doses/regimens or pegylated-interferon-2a .
-METHODS	Primary efficacy outcomes were changes in serum HBeAg and antibody , HBV-DNA , and alanine aminotransferase .
-METHODS	Principal safety outcomes were changes in laboratory values , pulmonary function , and adverse events .
-RESULTS	The study was prematurely terminated as phase III trials in hepatitis C infection indicated noninferior efficacy but inferior safety compared with pegylated-interferon-2a .
-RESULTS	Here , all treatment groups had a significant reduction in HBV-DNA from baseline .
-RESULTS	Reductions in HBV-DNA were not significantly different , except the 1200g every 4 weeks albinterferon dose which was inferior compared with pegylated-interferon-2a .
-RESULTS	The serum alanine aminotransferase levels decreased in all arms .
-RESULTS	The per-patient incidence of adverse events was not significantly different for albinterferon ( 96.4-100 % ) and pegylated-interferon-2a ( 93.1 % ) .
-RESULTS	Total adverse events , however , were higher for albinterferon and correlated to dose .
-RESULTS	Decreased lung function was found in all arms ( 93 % of patients ) , and was more common in some albinterferon groups .
-CONCLUSIONS	Albinterferon doses with similar anti-HBV efficacy to pegylated-interferon-2a had higher rates of certain adverse events , particularly changes in lung diffusion capacity ( http://www.clinicaltrials.gov number NCT00964665 ) .
-
-###24911342
-OBJECTIVE	A randomized controlled trial was carried out to study the effect of a recently proposed technique of ex vivo intra-arterial methylene blue injection of the surgical specimen removed for colorectal cancer on lymph node harvest and staging .
-METHODS	Between May 2012 and February 2013 , 100 consecutive colorectal cancer resection specimens in a single institution were randomly assigned to intervention ( methylene blue injection ) and control ( standard manual palpation technique ) groups before formalin fixation .
-METHODS	The specimen was then examined by the histopathologist for lymph nodes .
-RESULTS	Both groups were similar for age , sex , site of tumour , operation and tumour stage .
-RESULTS	In the intervention group , a higher number of nodes was found [ median 23 ( 5-92 ) vs. 15 ( 5-37 ) , P < 0.001 ] , with only one specimen not achieving the recommended minimum standard of 12 nodes [ 1/50 ( 2 % ) vs. 8/50 ( 16 % ) , P = 0.014 ] .
-RESULTS	However , there was no upstaging effect in the intervention group [ 23/50 ( 46.0 % ) vs. 20/50 ( 40.0 % ) ; P = 0.686 ] .
-RESULTS	With a significantly lower number of nodes harvested in rectal cancer , the positive effect of the intervention was particularly observed in the patients who underwent preoperative neoadjuvant radiotherapy [ median 30 nodes ( 12-57 ) vs. 11 ( 7-15 ) ; P = 0.011 ; proportion of cases with < 12 nodes 0/5 vs. 5/8 ( 62.5 % ) , P = 0.024 ] .
-CONCLUSIONS	Ex vivo intra-arterial methylene blue injection increases lymph node yield and can help to reduce the number of cases with a lower-than-recommended number of nodes , particularly in patients with rectal cancer having neoadjuvant treatment .
-CONCLUSIONS	The technique is easy to perform , cheap and saves time .
-
-###25635420
-BACKGROUND	Spinal anesthesia was considered as a reasonable anesthetic option in severe preeclampsia when cesarean delivery is indicated , and there is no indwelling epidural catheter or contraindication to spinal anesthesia .
-BACKGROUND	However , the ideal dose of intrathecal bupivacaine has not been quantified for cesarean delivery for severe preeclamptic patients .
-BACKGROUND	This study aimed to determine the ED 50 and ED 95 of intrathecal bupivacaine for severely preeclamptic patients undergoing elective cesarean delivery .
-METHODS	Two hundred severely preeclamptic patients are undergoing elective cesarean delivery under combined spinal-epidural anesthesia enrolled in this randomized , double-blinded , dose-ranging study .
-METHODS	Patients received 4 mg , 6 mg , 8 mg , or 10 mg intrathecal hyperbaric bupivacaine with 2.5 g sufentanil .
-METHODS	Successful spinal anesthesia was defined as a T6 sensory level achieved within 10 minutes after intrathecal drug administration and/or no epidural supplement was required during the cesarean section .
-METHODS	The ED 50 and ED 95 were calculated with a logistic regression model .
-RESULTS	ED 50 and ED 95 of intrathecal bupivacaine for successful spinal anesthesia were 5.67 mg ( 95 % confidence interval [ CI ] : 5.20-6 .10 mg ) and 8.82 mg ( 95 % CI : 8.14-9 .87 mg ) respectively .
-RESULTS	The incidence of hypotension in Group 8 mg and Group 10 mg was higher than that in Group 4 mg and Group 6 mg ( P < 0.05 ) .
-RESULTS	The sensory block was significantly different among groups 10 minutes after intrathecal injection ( P < 0.05 ) .
-RESULTS	The use of lidocaine in Group 4 mg was higher than that in other groups ( P < 0.05 ) .
-RESULTS	The use of phenylephrine in Group 8 mg and Group 10 mg was higher than that in the other two groups ( P < 0.05 ) .
-RESULTS	The lowest systolic blood pressure before the infant delivery of Group 8 mg and Group 10 mg was lower than the other two groups ( P < 0.05 ) .
-RESULTS	The satisfaction of muscle relaxation in Group 4 mg was lower than other groups ( P < 0.05 ) .
-RESULTS	There was no significant difference in patients ' satisfaction and the newborns ' Apgar score and the blood gas analysis of umbilical artery serum ( P > 0.05 ) .
-CONCLUSIONS	Our study showed that the ED 50 and ED 95 of intrathecal bupivacaine for severely preeclamptic patients undergoing elective cesarean delivery were 5.67 mg and 8.82 mg , respectively .
-CONCLUSIONS	In addition , decreasing the dose of intrathecal bupivacaine could reduce the incidence of maternal hypotension .
-
-###25349333
-BACKGROUND	We tested the hypothesis that statin use in individuals with COPD is associated with a reduced risk of exacerbations .
-METHODS	We identified 5794 individuals with COPD and a measurement of C reactive protein ( CRP ) in the Copenhagen General Population Study ( 2003-2008 ) .
-METHODS	During 3years of follow-up we recorded exacerbations with hospital admissions or oral corticosteroid treatment .
-METHODS	In a nested case-control design , matching on age , gender , smoking , COPD severity and comorbidity , we estimated the association between statin use and exacerbations .
-METHODS	In addition , we examined the association between statin use and high CRP ( > 3mg/L ) , and the association between high CRP and exacerbations during follow-up .
-RESULTS	Statin use was associated with reduced odds of exacerbations in crude analysis , OR = 0.68 ( 95 % CI 0.51 to 0.91 , p = 0.01 ) , as well as in multivariable conditional logistic regression analysis , OR = 0.67 ( 0.48 to 0.92 , p = 0.01 ) .
-RESULTS	However , in the subgroup with the most severe COPD and without cardiovascular comorbidity , we observed a null association between statin use and exacerbations , OR = 1.1 ( 0.5 to 2.1 , p = 0.83 ) .
-RESULTS	Furthermore , statin use was associated with reduced odds of a high CRP , OR = 0.69 ( 0.56 to 0.85 , p < 0.001 ) , and a high CRP was associated with an increased risk of exacerbations , HR = 1.62 ( 1.35 to 1.94 , p < 0.001 ) .
-RESULTS	We estimated the percentage of excess risk of the association of statin use with exacerbations possibly mediated through a reduction of CRP to be 14 % ( 4-51 % ) .
-CONCLUSIONS	Statin use was associated with reduced odds of exacerbations in individuals with COPD from the general population , although this was not apparent in those with the most severe COPD without cardiovascular comorbidity .
-CONCLUSIONS	Statins may thus only associate with reduced risk of exacerbations in patients with COPD with coexisting cardiovascular disease .
-
-###25054483
-BACKGROUND	Research on the use of a pressurized metered dose inhaler ( pMDI ) with spacer ( pMDI/spacer ) in children has indicated oral inhalation via the spacer mouthpiece is more efficient than the combination of oral and nasal inhalation that occurs when a pMDI/spacer is used with a facemask .
-BACKGROUND	Changes in pMDI formulations and developments in spacer and facemask designs have highlighted the need for new comparative studies of spacer use , particularly focusing on the age at which children can be taught to transition from use of a pMDI/spacer with facemask to use of the spacer mouthpiece .
-METHODS	Twelve children aged 3-5 years ( 7 males ) with stable asthma were recruited .
-METHODS	Of these , 10 children ( 6 males ) completed both arms of the study .
-METHODS	A transmission scan of each compliant subject was taken using a 37 MBq ( 99m ) Tc flood source .
-METHODS	Actuations ( 2-3 ) of a ( 99m ) Tc-radiolabeled albuterol pMDI were administered through an antistatic spacer ( OptiChamber Diamond ) via either a facemask ( medium LiteTouch facemask ) , or the spacer mouthpiece .
-METHODS	The subject 's inhalation pattern was simultaneously recorded using a pMDI Datalogger , and narrative data relating to tolerance and compliance were documented .
-METHODS	Anterior and posterior planar scintigraphic scans were taken immediately after aerosol administration .
-RESULTS	Mean ( SD ) lung deposition ( % total dose ) was 18.1 ( 9.1 ) % with the facemask and 22.5 ( 7.9 ) % with the spacer mouthpiece ( p > 0.05 ) .
-RESULTS	Peripheral lung deposition ( expressed as peripheral : central ( P : C ) ratio ) was higher in 7 out of 10 children with the facemask compared with the spacer mouthpiece : 1.3 ( 0.26 ) vs. 1.2 ( 0.35 ) ; ( p = 0.11 ) .
-RESULTS	Head and neck deposition was higher with use of the facemask compared with the spacer mouthpiece : 19.7 ( 10.6 ) % vs. 10.8 ( 5.3 ) % ( p = 0.011 ) .
-CONCLUSIONS	Lung deposition achieved using the spacer with facemask was higher than previously reported , with a difference of only 4.4 % of total dose measured compared to the deposition with mouthpiece .
-CONCLUSIONS	This may be due to a combination of factors including pMDI formulation , and use of an antistatic spacer with a flexible , well-fitting facemask .
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-###25419886
-BACKGROUND	There is a shortage of literature describing the experience of individuals who have participated in a physical activity and mobile health ( mHealth ) intervention .
-BACKGROUND	Many physical activity interventions are of short duration and do not report long-term changes in clinical measures or adoption of prescribed health behaviors .
-BACKGROUND	Previously , we have reported the clinical and behavioral outcomes from the first phase of a physical activity prescription and mHealth intervention delivered through the primary care setting .
-BACKGROUND	The purpose of this next phase is to perform a longitudinal follow-up 6-months postintervention .
-METHODS	Mixed methods analysis including repeated measures ANOVA of functional aerobic capacity ( VO2max ) at preintervention , postintervention , and follow-up clinic visits , and whole text analysis of semistructured interviews discussing the participant experience in a health behavior intervention .
-RESULTS	Twenty participants , mean age 63 5 years , participated .
-RESULTS	Gains made in VO2max were maintained at 6 months ( P < 0.05 ) .
-RESULTS	Participants reported engaging in sustained and routine physical activity , yet some identified a need for additional support to adopt the prescribed health behaviors .
-RESULTS	Emergent themes included the desire for short-term mHealth intervention to educate individuals about prescribed health behaviors without need for ongoing management by clinicians , leveraging mHealth to build social networks around prescribed health behaviors and to connect individuals to build a sense of community , and participant views of physical activity as medicine .
-CONCLUSIONS	The present study investigated both the long-term adoption of physical activity behaviors as well as the participant experience in a physical activity and mHealth intervention .
-CONCLUSIONS	Findings from the current study may be used to inform the development of user-centered lifestyle interventions .
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-###25438954
-BACKGROUND	This study was designed to analyze and compare plasma levels of 8-isoprostane ( 8-epiPGF2 ) , a biomarker of lipid peroxidation , and uric acid ( UA ) , a marker of the antioxidant status , in standard laparoscopic ( LC ) and laparoendoscopic single-site cholecystectomy ( LSSC ) .
-METHODS	Forty patients with noncomplicated cholelithiasis were randomized to undergo either LSSC ( n = 20 ) or LC ( n = 20 ) .
-METHODS	The patients had body mass index < 30 , American Society of Anesthesiologists score I or II , and no previous upper gastrointestinal surgery .
-METHODS	Blood samples were taken preoperatively and 6 h and 24 h postoperatively .
-METHODS	Levels of 8-epiPGF2 were determined using enzyme-linked immunosorbent assay , whereas levels of UA were calculated using automated analyzer .
-RESULTS	No significant differences were observed in operative data among the groups .
-RESULTS	Levels of 8-epiPGF2 were significantly higher in LSSC compared with LC at 6 h ( P = 0.003 ) and 24 h ( P < 0.001 ) .
-RESULTS	8-epiPGF2 levels showed significant changes over time in LC ( LSSC : P = 0.720 , LC : P < 0.001 ) .
-RESULTS	UA levels were significantly higher in LC compared with LSSC , 24 h postoperatively ( P = 0.021 ) .
-RESULTS	No significant changes over time in the UA levels in both groups ( LSSC : P = 0.056 , LC : P = 0.205 ) .
-CONCLUSIONS	LSSC is associated with increased oxidative stress compared with LC .
-CONCLUSIONS	Further studies are needed to confirm these results .
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-###25423631
-OBJECTIVE	To compare intravitreal bevacizumab versus ranibizumab as adjuvant treatment prior to pars plana vitrectomy ( PPV ) in proliferative diabetic retinopathy ( PDR ) with respect to parameters of surgical complexity .
-METHODS	Prospective , randomized , double-masked pilot study of patients requiring PPV for nonclearing vitreous hemorrhage or tractional retinal detachment ( TRD ) secondary to PDR .
-METHODS	Patients were randomized to receive either intravitreal bevacizumab or ranibizumab at standard doses 1 week preoperatively .
-METHODS	Measured parameters included total surgical time , presence of TRD , intraoperative bleeding , iatrogenic retinal breaks , and use of endolaser and endodiathermy or silicone oil .
-RESULTS	A total of 29 patients were recruited .
-RESULTS	For surgical parameters , there were no statistically significant differences between the groups in the univariate analyses .
-RESULTS	Multivariable analysis showed no statistically significant difference for total surgical time .
-CONCLUSIONS	This pilot study suggests that intravitreal bevacizumab and ranibizumab are equivalent as surgical adjuvants when used as pre-treatment in patients with PDR undergoing PPV .
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-###25399948
-BACKGROUND	Infants with acute lymphoblastic leukemia ( ALL ) present with aggressive disease and a poor prognosis .
-BACKGROUND	Early relapse within 6-9 months of diagnosis is common .
-BACKGROUND	Approximately 75 % of infants have MLL-rearranged ( MLL-R ) ALL with event free survival ( EFS ) ranging from 20 % to 30 % .
-BACKGROUND	Children 's Oncology Group ( COG ) P9407 used shortened ( 46 weeks ) , intensified therapy to address early relapse and poor EFS .
-METHODS	P9407 therapy was modified three times for induction toxicity resulting in three cohorts of therapy .
-METHODS	One hundred forty-seven infants were enrolled in the third cohort .
-RESULTS	We report an overall 5-year EFS and OS of 42.36 % and 52.96.5 % respectively .
-RESULTS	Poor prognostic factors included age 90 days at diagnosis , MLL-R ALL and white cell count 50,000 / l. For infants 90 days of age , the 5-year EFS was 15.510.1 % and 48.56.7 % for those > 90 days ( P < 0.0001 ) .
-RESULTS	Among infants > 90 days of age , 5-year EFS rates were 43.88 % for MLL-R versus 69.113.6 % for MLL-germline ALL ( P < 0.0001 ) .
-CONCLUSIONS	Age 90 days at diagnosis was the most important prognostic factor .
-CONCLUSIONS	Despite shortened therapy with early intensification , EFS remained less than 50 % overall in MLL-R ALL .
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-###25450134
-OBJECTIVE	To compare a computer-assisted home exercise program with conservative home-training following printed instructions in the rehabilitation of elderly patients with vestibular dysfunction .
-METHODS	Single-blind , randomized , controlled trial .
-METHODS	Geriatric department of a university hospital .
-METHODS	Patients with chronic dizziness due to vestibular dysfunction ( N = 63 ) were randomly assigned to either rehabilitation in the clinic followed by computer-assisted home exercises ( intervention group : n = 32 ) or rehabilitation in the clinic followed by home exercises according to printed instructions ( control group : n = 31 ) .
-METHODS	Patients in the intervention group received assisted rehabilitation by a computer program .
-METHODS	Measurements at baseline and at 8 and 16 weeks were compared .
-METHODS	These included the One Leg Stand Test , Dynamic Gait Index , Chair Stand Test , Motion Sensitivity Test , Short Form-12 , Dizziness Handicap Inventory , and visual analog scale .
-RESULTS	Both groups improved significantly during 16 weeks of rehabilitation .
-RESULTS	However , neither t tests nor repeated-measures analysis of variance demonstrated any significant differences between the 2 groups .
-RESULTS	The overall compliance rate to computer program exercises during 16 weeks was 57 % .
-CONCLUSIONS	A computer-assisted program to support the home training of elderly patients with vestibular dysfunction did not improve rehabilitation more than did printed instructions .
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-###24469436
-OBJECTIVE	Atrial fibrillation ( AF ) ablation can result in oesophageal injuries that lead to atrio-oesophageal fistulae , a life-threatening complication .
-OBJECTIVE	This study aimed to evaluate whether oesophageal cooling could prevent oesophageal lesions complicating AF ablation .
-RESULTS	We randomly assigned 100 patients with drug-resistant AF to an oesophageal cooling group or a control group .
-RESULTS	In the oesophageal cooling group , we injected 5 mL of ice water into the oesophagus prior to radiofrequency ( RF ) energy delivery adjacent to the oesophagus .
-RESULTS	If the oesophageal temperature reached 42C , the RF energy delivery was stopped , and the ice water injection was repeated .
-RESULTS	In the control group , oesophageal cooling was not applied .
-RESULTS	Oesophageal endoscopy was performed 1 day after the catheter ablation , and lesions were qualitatively assessed as mild , moderate , or severe .
-RESULTS	The numbers of ablation sites with an oesophageal temperature of > 42C were 1.7 1.4 and 2.6 1.7 in the oesophageal cooling group and the control group , respectively ( P = 0.04 ) , and the maximal oesophageal temperature at those sites was 43.0 0.6 and 44.7 0.9 C ( P < 0.0001 ) .
-RESULTS	Oesophageal lesions occurred almost equally between the oesophageal cooling group [ 10 of 50 patients ( 20 % ) ] and the control group [ 11 of 50 patients ( 22 % ) ] .
-RESULTS	However , the severity of the oesophageal lesions was slightly milder in the oesophageal cooling group ( three moderate , seven mild ) than in the control group ( three severe , one moderate , seven mild ) .
-CONCLUSIONS	Oesophageal cooling may alleviate the severity of oesophageal lesions but does not reduce the incidence of this complication under the specific protocol evaluated here .
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-###26148379
-BACKGROUND	Like other acute and chronic infections , Brucella infection leads to endothelial dysfunction .
-BACKGROUND	Furthermore , it has been suggested that the chronic inflammatory state present in chronic infectious diseases leads to an acceleration in atherosclerosis .
-BACKGROUND	For the prediction of CAD , it is possible to use epicardial fat thickness ( EFT ) as an adjunctive marker beside the classical risk factors , as it is easily and non-invasively evaluated by transthoracic echocardiography .
-BACKGROUND	The purpose of this study was to investigate the presence of impaired myocardial performance as well as of increased arterial stiffness and EFT in patients who had been infected with brucellosis in the past .
-METHODS	Included in the study were twenty-seven brucellosis patients and twenty-six healthy volunteers .
-METHODS	Using EFT and transthoracic echocardiography , which included Doppler echocardiography in combination with tissue Doppler imaging ( TDI ) , all the patients were examined to measure their aortic stiffness index ( AoSI ) , aortic distensibility ( AoD ) , and aortic elastic modulus ( AoEM ) values .
-RESULTS	A statistically significant increase was observed in hs-CRP , aortic stiffness index , aortic elastic modulus and EFT in brucellosis patients when compared with the controls ( 2.46 + / - 1.40 vs. 1.71 ?
-RESULTS	0.61 , P = 0.016 ; 9.69 + / - 6.99 vs. 2.14 + / - 0.72 , P < 0.001 ; 11.17 + / - 8.60 vs 2.18 + / - 0.90 , P < 0.001 ; 0.76 + / - 0.08 vs. 0.63 + / - 0.10 , P < 0.001 ) .
-RESULTS	On the other hand , there was a significant decrease in aortic strain and aortic distensibility ( 7.41 ?
-RESULTS	6.82 vs 18.26 + / - 5.83 , P < 0.001 ; 1.83 + / - 1.71 vs. 5.22 + / - 1.72 , P < 0.001 , respectively ) .
-RESULTS	No difference was observed between the two groups with respect to the left ventricular myocardial performance index ( MPI ) ( 0.62 + / - 0.15 vs. 0.61 + / - 0.13 , P = 0.859 ) .
-CONCLUSIONS	In this study , we demonstrated for the first time in the literature thatthere was impaired aortic elasticity and increased EFT in patients with brucellosis , while the myocardial performance index remained unaffected .
-CONCLUSIONS	We also determined that these effects had a significant correlation with inflammation .
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-###25809235
-BACKGROUND	Breast cancer survivors experience long-term physical and psychological sequelae after their primary treatment that negatively influence their quality of life ( QOL ) and increase depressive symptoms .
-BACKGROUND	Group-based cognitive-behavioral stress management ( CBSM ) delivered after surgery for early-stage breast cancer was previously associated with better QOL over a 12-month follow-up and with fewer depressive symptoms up to 5 years after study enrollment .
-BACKGROUND	This 8 - to 15-year follow-up ( median , 11 years ) of a previously conducted trial ( NCT01422551 ) evaluated whether women in this cohort receiving CBSM had fewer depressive symptoms and better QOL than controls at an 8 - to 15-year follow-up .
-METHODS	Women with stage 0 to IIIb breast cancer were initially recruited 2 to 10 weeks after surgery and randomized to a 10-week CBSM intervention or a 1-day psychoeducational control group .
-METHODS	One hundred women ( 51 CBSM patients and 49 controls ) were recontacted 8 to 15 years after study enrollment to participate in a follow-up assessment .
-METHODS	The Center for Epidemiologic Studies-Depression ( CES-D ) scale and the Functional Assessment of Cancer Therapy-Breast ( FACT-B ) were self-administered .
-METHODS	Multiple regression was employed to evaluate group differences on the CES-D scale and FACT-B over and above effects of confounding variables .
-RESULTS	Participants assigned to CBSM reported significantly lower depressive symptoms ( d , 0.63 ; 95 % confidence interval [ CI ] , 0.56-0 .70 ) and better QOL ( d , 0.58 ; 95 % CI , 0.52-0 .65 ) above the effects of the covariates .
-CONCLUSIONS	Women who received CBSM after surgery for early-stage breast cancer reported lower depressive symptoms and better QOL than the control group up to 15 years later .
-CONCLUSIONS	Early implementation of cognitive-behavioral interventions may influence long-term psychosocial functioning in breast cancer survivors .
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-###25016974
-OBJECTIVE	Relatively few studies have examined the long-term outcome of psychotherapy in social anxiety disorder .
-OBJECTIVE	The authors previously reported findings of a clinical trial comparing cognitive-behavioral therapy ( CBT ) , psychodynamic therapy , and a wait-list control .
-OBJECTIVE	The purpose of the present study was to follow the participants ' status over the ensuing 24 months .
-METHODS	Outpatients with social anxiety disorder who were treated with CBT ( N = 209 ) or psychodynamic therapy ( N = 207 ) in the previous trial were assessed 6 , 12 , and 24 months after the end of therapy .
-METHODS	Primary outcome measures were rates of remission and response .
-RESULTS	For both CBT and psychodynamic therapy , response rates were approximately 70 % by the 2-year follow-up .
-RESULTS	Remission rates were nearly 40 % for both treatment conditions .
-RESULTS	Rates of response and remission were stable or tended to increase for both treatments over the 24-month follow-up period , and no significant differences were found between the treatment conditions after 6 months .
-CONCLUSIONS	CBT and psychodynamic therapy were efficacious in treating social anxiety disorder , in both the short - and long-term , when patients showed continuous improvement .
-CONCLUSIONS	Although in the short-term , intention-to-treat analyses yielded some statistically significant but small differences in favor of CBT in several outcome measures , no differences in outcome were found in the long-term .
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-###24595778
-OBJECTIVE	Youth in high-poverty neighborhoods have high rates of emotional problems .
-OBJECTIVE	Understanding neighborhood influences on mental health is crucial for designing neighborhood-level interventions .
-OBJECTIVE	To perform an exploratory analysis of associations between housing mobility interventions for children in high-poverty neighborhoods and subsequent mental disorders during adolescence .
-METHODS	The Moving to Opportunity Demonstration from 1994 to 1998 randomized 4604 volunteer public housing families with 3689 children in high-poverty neighborhoods into 1 of 2 housing mobility intervention groups ( a low-poverty voucher group vs a traditional voucher group ) or a control group .
-METHODS	The low-poverty voucher group ( n = 1430 ) received vouchers to move to low-poverty neighborhoods with enhanced mobility counseling .
-METHODS	The traditional voucher group ( n = 1081 ) received geographically unrestricted vouchers .
-METHODS	Controls ( n = 1178 ) received no intervention .
-METHODS	Follow-up evaluation was performed 10 to 15 years later ( June 2008-April 2010 ) with participants aged 13 to 19 years ( 0-8 years at randomization ) .
-METHODS	Response rates were 86.9 % to 92.9 % .
-METHODS	Presence of mental disorders from the Diagnostic and Statistical Manual of Mental Disorders ( Fourth Edition ) within the past 12 months , including major depressive disorder , panic disorder , posttraumatic stress disorder ( PTSD ) , oppositional-defiant disorder , intermittent explosive disorder , and conduct disorder , as assessed post hoc with a validated diagnostic interview .
-RESULTS	Of the 3689 adolescents randomized , 2872 were interviewed ( 1407 boys and 1465 girls ) .
-RESULTS	Compared with the control group , boys in the low-poverty voucher group had significantly increased rates of major depression ( 7.1 % vs 3.5 % ; odds ratio ( OR ) , 2.2 [ 95 % CI , 1.2-3 .9 ] ) , PTSD ( 6.2 % vs 1.9 % ; OR , 3.4 [ 95 % CI , 1.6-7 .4 ] ) , and conduct disorder ( 6.4 % vs 2.1 % ; OR , 3.1 [ 95 % CI , 1.7-5 .8 ] ) .
-RESULTS	Boys in the traditional voucher group had increased rates of PTSD compared with the control group ( 4.9 % vs 1.9 % , OR , 2.7 [ 95 % CI , 1.2-5 .8 ] ) .
-RESULTS	However , compared with the control group , girls in the traditional voucher group had decreased rates of major depression ( 6.5 % vs 10.9 % ; OR , 0.6 [ 95 % CI , 0.3-0 .9 ] ) and conduct disorder ( 0.3 % vs 2.9 % ; OR , 0.1 [ 95 % CI , 0.0-0 .4 ] ) .
-CONCLUSIONS	Interventions to encourage moving out of high-poverty neighborhoods were associated with increased rates of depression , PTSD , and conduct disorder among boys and reduced rates of depression and conduct disorder among girls .
-CONCLUSIONS	Better understanding of interactions among individual , family , and neighborhood risk factors is needed to guide future public housing policy changes .
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-###25164259
-OBJECTIVE	Observational studies suggest that minimal gestational weight gain ( GWG ) may optimize pregnancy outcomes for obese women .
-OBJECTIVE	This trial tested the efficacy of a group-based weight management intervention for limiting GWG among obese women .
-METHODS	One hundred and fourteen obese women ( BMI [ meanSD ] 36.74.9 kg/m ( 2 ) ) were randomized between 7 and 21 weeks ' ( 14.92.6 ) gestation to intervention ( n = 56 ) or usual care control conditions ( n = 58 ) .
-METHODS	The intervention included individualized calorie goals , advice to maintain weight within 3 % of randomization and follow the Dietary Approaches to Stop Hypertension dietary pattern without sodium restriction , and attendance at weekly group meetings until delivery .
-METHODS	Control participants received one-time dietary advice .
-METHODS	Our three main outcomes were maternal weight change from randomization to 2 weeks postpartum and from randomization to 34 weeks gestation , and newborn large-for-gestational age ( birth weight > 90th percentile , LGA ) .
-RESULTS	Intervention participants gained less weight from randomization to 34 weeks gestation ( 5.0 vs. 8.4 kg , mean difference = -3.4 kg , 95 % CI [ -5.1 -1.8 ] ) , and from randomization to 2 weeks postpartum ( -2.6 vs. +1.2 kg , mean difference = -3.8 kg , 95 % CI [ -5.9 -1.7 ] ) .
-RESULTS	They also had a lower proportion of LGA babies ( 9 vs. 26 % , odds ratio = 0.28 , 95 % CI [ 0.09-0 .84 ] ) .
-CONCLUSIONS	The intervention resulted in lower GWG and lower prevalence of LGA newborns .
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-###25975045
-OBJECTIVE	To examine whether transcutaneous electric nerve stimulation at acupoints ( Acu-TENS ) improved the biochemical and physical indices of patients with type 2 diabetes mellitus ( T2DM ) .
-METHODS	Ninety subjects with T2DM were divided randomly into a control group ( n = 30 ) , aerobic exercise group ( n = 30 ) , or Acu-TENS group ( n = 30 ) .
-METHODS	In addition to conventional diabetes drug treatment , patients in the Acu-TENS group received acupoint stimulation , the aerobic exercise group engaged in walking exercises , and the control group was given sham electrical stimulation .
-METHODS	All groups were treated for 30 min for each session and five times a week for 2 months .
-METHODS	The indices of glycosylated hemoglobin , 2 h postprandial glucose , fasting serum insulin , triglyceride , total cholesterol , and body mass index were assessed at pre-treatment , post-treatment , and follow-up , which was 2 months after treatment .
-RESULTS	The indices of the control group were not changed ( P > 0.05 ) at the three time points .
-RESULTS	At the pre-treatment measurement , there were significant differences ( P > 0.05 ) in indices among the three groups .
-RESULTS	At post-treatment , each index of the two groups was lower than that of the control group ( P < 0.05 ) , and improved in comparison with the pre-treatment measurement ( P < 0.05 ) .
-RESULTS	In follow-up , each index of the aerobic exercise group and Acu-TENS group increased , but was still decreased compared with the pre-treatment value ( P < 0.05 ) , excluding body mass index .
-CONCLUSIONS	Acu-TENS could improve the state of patients with T2DM and be used as a therapy in clinical application .
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-###24461333
-OBJECTIVE	To describe the subjective experience of patients and surgeons during laser in situ keratomileusis ( LASIK ) using the Intralase 60 kHz or the Visumax 500 kHz femtosecond laser .
-METHODS	Singapore National Eye Centre , Singapore .
-METHODS	Prospective randomized clinical study .
-METHODS	In myopic patients , LASIK was performed with the corneal flap created using the 60 kHz laser in 1 eye and the 500 kHz laser in the contralateral eye .
-METHODS	Postoperatively , patients completed a standardized validated questionnaire about their subjective intraoperative experiences ( eg , light perception , pain , fear ) .
-METHODS	Surgeons reported their intraoperative experiences and preferences .
-RESULTS	Loss of light perception occurred in 50.0 % of 60 kHz laser cases and 0 % of 500 kHz laser cases during docking and in 63.0 % and 0 % of cases , respectively , during laser flap creation ( P < .0001 ) .
-RESULTS	The mean pain score with the 60 kHz laser was significantly higher during docking ( P < .0001 ) but not during laser flap cutting ( P = .006 ) .
-RESULTS	Subconjunctival hemorrhage occurred in 67.4 % of eyes with the 60 kHz laser and in 2.2 % of eyes with the 500 kHz laser ( P < .0001 ) .
-RESULTS	The 500 kHz laser was preferred by 78.3 % of patients , while 21.7 % preferred the 60 kHz laser ( P < .0001 ) .
-RESULTS	The surgeons preferred the 60 kHz laser in 50.0 % of cases and the 500 kHz laser in 8.7 % ( P < .0001 ) ; 41.3 % had no preference .
-CONCLUSIONS	Patients preferred surgery with the 500 kHz laser with no loss of light perception , less pain , less fear , and less subconjunctival hemorrhage .
-CONCLUSIONS	Surgeons preferred the 60 kHz laser .
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-###24767736
-BACKGROUND	Peak internal knee abduction moment is a common surrogate variable associated with medial compartment knee loading .
-BACKGROUND	Stair descent has been shown to yield a greater peak knee abduction moment compared to level-walking .
-BACKGROUND	Changes in step width ( SW ) may lead to changes in frontal plane lower extremity limb alignment in the frontal plane and alter peak knee abduction moment .
-BACKGROUND	The purpose of this study was to investigate the effects of increased SW on frontal plane knee biomechanics during stair descent in healthy older adults .
-METHODS	Twenty healthy adults were recruited for the study .
-METHODS	A motion analysis system was used to obtain three-dimensional lower limb kinematics during testing .
-METHODS	An instrumented 3-step staircase with two additional customized wooden steps was used to collect ground reaction forces ( GRF ) data during stair descent trials .
-METHODS	Participants performed five stair descent trials at their self-selected speed using preferred , wide ( 26 % leg length ) , and wider ( 39 % leg length ) SW .
-RESULTS	The preferred normalized SW in older adults during stair descent was 20 % of leg length .
-RESULTS	Wide and wider SW during stair descent reduced both first and second peak knee adduction angles and abduction moments compared to preferred SW in healthy adults .
-CONCLUSIONS	Increased SW reduced peak knee adduction angles and abduction moments .
-CONCLUSIONS	The reductions in knee abduction moments may have implications in reducing medial compartment knee loads during stair descent .
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-###24794140
-OBJECTIVE	To evaluate the prognostic importance of transient or persistent elevations of cardiac troponin-I ( cTnI ) and N-terminal-B-type natriuretic peptide ( NT-proBNP ) in atrial fibrillation ( AF ) .
-METHODS	Plasma samples were obtained at randomisation and after 3 months in 2514 patients with AF in the RE-LY trial ; median follow-up was 2.0 years .
-METHODS	Patients were grouped based on levels at the two time points according to detectable cTnI levels ( 0.01 g/L ) or NT-proBNP levels above median ( 778 ng/L ) .
-METHODS	These groups were related to occurrence of stroke or cardiovascular events evaluated with Cox models adjusting for established risk factors .
-RESULTS	The proportion of patients with detectable cTnI levels at both time points was 48.5 % , at one time point 28.5 % and at neither time point 21.0 % .
-RESULTS	Patients with detectable cTnI at both time points had substantially higher rates of stroke compared with those with transient elevations and those with no elevation at either time point ( p < 0.005 , effect of cTnI ) .
-RESULTS	Persistent elevation of either or both cardiac biomarkers at baseline and 3 months was associated with a higher risk for cardiovascular events and mortality ( p < 0.0001 ) .
-RESULTS	Prognostic prediction improved most with the use of repeated measurements of both cardiac biomarkers simultaneously ( p < 0.05 ) and achieved C-statistic 0.644 for stroke compared with 0.611 for CHADS2-score .
-CONCLUSIONS	Persistent elevation of troponin and NT-proBNP indicates a worse prognosis than transient elevations or no elevations of either marker .
-CONCLUSIONS	Prognostication of stroke , death and thromboembolic events is improved by the use of repeated determinations of cardiac biomarkers .
-BACKGROUND	http://www.clinicaltrials.gov , NCT00262600 .
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-###24507657
-BACKGROUND	Although reperfusion injury has been shown to be responsible for cardiomyocytes death after an acute myocardial infarction , there is currently no drug on the market that reduces this type of injury .
-BACKGROUND	TRO40303 is a new cardioprotective compound that was shown to inhibit the opening of the mitochondrial permeability transition pore and reduce infarct size after ischemia-reperfusion in a rat model of cardiac ischemia-reperfusion injury .
-METHODS	In the rat model , the therapeutic window and the dose effect relationship were investigated in order to select the proper dose and design for clinical investigations .
-METHODS	To evaluate post-ischemic functional recovery , TRO40303 was tested in a model of isolated rat heart .
-METHODS	Additionally , TRO40303 was investigated in a Phase I randomized , double-blind , placebo controlled study to assess the safety , tolerability and pharmacokinetics of single intravenous ascending doses of the compound ( 0.5 to 13 mg/kg ) in 72 healthy male , post-menopausal and hysterectomized female subjects at flow rates from 0.04 to 35 mL/min ( EudraCT number : 2010-021453-39 ) .
-METHODS	This work was supported in part by the French Agence Nationale de la Recherche .
-RESULTS	In the vivo model , TRO40303 reduced infarct size by 40 % at 1 mg/kg and by 50 % at 3 and 10 mg/kg given by intravenous bolus and was only active when administered before reperfusion .
-RESULTS	Additionally , TRO40303 provided functional recovery and reduced oxidative stress in the isolated rat heart model.These results , together with pharmacokinetic based allometry to human and non-clinical toxicology data , were used to design the Phase I trial .
-RESULTS	All the tested doses and flow rates were well tolerated clinically .
-RESULTS	There were no serious adverse events reported .
-RESULTS	No relevant changes in vital signs , electrocardiogram parameters , laboratory tests or physical examinations were observed at any time in any dose group .
-RESULTS	Pharmacokinetics was linear up to 6 mg/kg and slightly ~ 1.5-fold , hyper-proportional from 6 to 13 mg/kg .
-CONCLUSIONS	These data demonstrated that TRO40303 can be safely administered by the intravenous route in humans at doses expected to be pharmacologically active .
-CONCLUSIONS	These results allowed evaluating the expected active dose in human at 6 mg/kg , used in a Phase II proof-of-concept study currently ongoing .
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-###24225081
-BACKGROUND	Age-related muscle loss ( that is , sarcopenia ) is a common health problem among older people .
-BACKGROUND	Physical exercise and dietary protein have been emphasized in prevention and treatment of sarcopenia .
-BACKGROUND	Rigorous trials investigating the effects of protein supplementation on physical performance in sarcopenic populations are still scarce .
-BACKGROUND	The aim of this study is to investigate the effects of protein supplementation along with simple home-based exercises on physical performance among home-dwelling sarcopenic older people .
-METHODS	During 2012 the entire 75 and older population ( N = 3,275 ) living in Porvoo , Finland was contacted via a postal questionnaire .
-METHODS	Persons at risk of sarcopenia are screened with hand grip strength and gait speed .
-METHODS	Poorly performing persons are further examined by segmental bioimpendance spectroscopy to determine their skeletal muscle index .
-METHODS	Sarcopenic patients ( target N = 250 ) will be enrolled in a 12-month randomized controlled trial with three arms : 1 ) no supplementation , 2 ) protein supplementation ( 20 grams twice a day ) , and 3 ) isocaloric placebo .
-METHODS	All the participants will receive instructions on simple home-based exercises , dietary protein , and vitamin D supplementation ( 20 g/d ) .
-METHODS	The recruitment of patients will be completed during 2013 .
-METHODS	The primary endpoint of the trial is the change in short physical performance battery score and percentage of patients maintaining or improving their physical performance .
-METHODS	Secondary endpoints will be , among other things , changes in muscle functions , nutritional status , body composition , cognition , quality of life , use of health care services , falls , and mortality .
-METHODS	The assessment times will be 0 , 6 , 12 and 24 months .
-CONCLUSIONS	To our knowledge , this is the first large scale randomized controlled trial among community dwelling older people with sarcopenia that focuses on the effects of protein supplementation on physical performance .
-BACKGROUND	ACTRN12612001253897 , date of registration 28 October 2012 , first patient was randomized 11 April 2012 .
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-###24694794
-BACKGROUND	AST-120 ( spherical carbon adsorbent ) was previously reported to be effective for perianal fistula healing in Japanese patients with mild-to-moderate Crohn 's disease .
-METHODS	To evaluate the efficacy and safety of AST-120 in a Western population , a phase 3 , multicenter , randomized , double-blind , placebo-controlled , study ( FHAST-1 ) was conducted in adult patients with at least 1 draining perianal fistula and a Crohn 's disease activity index < 400 .
-METHODS	Patients received either AST-120 or matching placebo at a dose of 2 g 3 times daily for 8 weeks .
-METHODS	The primary endpoint was the proportion of patients with treatment success , defined as a 50 % reduction in the number of draining fistulae , at both weeks 4 and 8 .
-METHODS	A multivariate model was generated to assess covariates for treatment success among baseline variables .
-RESULTS	Two hundred forty-nine patients were randomized ( AST-120 ; n = 122 ; placebo , n = 127 ) .
-RESULTS	The proportions of patients achieving the primary endpoint were no different between treatment groups ( 13.9 % versus 16.5 % , P = 0.6 ) .
-RESULTS	No differences in fistula response were noted at week 4 ( 23.0 % versus 25.2 % , P = 0.77 ) or week 8 ( 27.0 versus 34.6 % , P = 0.22 ) .
-RESULTS	Serum C-reactive protein concentrations > 0.6 mg/dL and Crohn 's disease activity index scores > 151 at baseline were associated with a reduced likelihood of treatment success ( odds ratio , 0.40 ; confidence interval , 0.19-0 .87 ; P = 0.02 ; and odds ratio , 0.45 ; confidence interval , 0.21-0 .97 ; P = 0.04 , respectively ) .
-CONCLUSIONS	In this largest placebo-controlled trial to date to evaluate the impact of a therapeutic agent on perianal fistulae in Crohn 's disease , the efficacy of AST-120 could not be confirmed .
-CONCLUSIONS	An inverse relationship was observed between both inflammatory and clinical disease activity and fistula response .
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-###25433220
-OBJECTIVE	To examine the effects of communication skills training on physiotherapists ' supportive behavior during clinical practice .
-METHODS	Randomized trial .
-METHODS	Hospital outpatient physiotherapy clinics .
-METHODS	Physiotherapists ( N = 24 ) and patients ( N = 24 ) with chronic low back pain .
-METHODS	Two hospital clinics were randomly assigned to the intervention arm .
-METHODS	Physiotherapists ( n = 12 ) received 8 hours of communication skills training focused on supporting patients ' psychological needs .
-METHODS	Physiotherapists ( n = 12 ) from 2 other hospital clinics formed a waitlist control arm .
-METHODS	Verbal communication between each physiotherapist and a patient was recorded on an audiotape , and independent , blinded raters used the Health Care Climate Questionnaire to assess physiotherapists ' needs-supportive behavior ( primary outcome ) .
-RESULTS	Independent raters ' Health Care Climate Questionnaire scores favored the intervention arm ( Cohen 's d = 2.27 ; P < .01 ) .
-CONCLUSIONS	Compared with controls , independent ratings demonstrated that physiotherapists who completed the Communication style and exercise compliance in physiotherapy training were found to provide greater support for patients ' needs in a single assessed session .
-CONCLUSIONS	Long-term maintenance of this needs-supportive behavior should be examined .
-
-###24349404
-BACKGROUND	Very little is known about the relationship between non-sickle cell anemia and stroke .
-BACKGROUND	The purpose of this study is to evaluate the association of iron-deficiency anemia ( IDA ) with stroke based on a nationwide coverage database in Taiwan .
-METHODS	The case-control study subjects were obtained from the Taiwanese Longitudinal Health Insurance Database 2000 .
-METHODS	We included 51,093 subjects with stroke as cases and randomly selected 153,279 controls ( 3 controls per case ) in this study.Separate conditional logistic regression analyses were used to calculate the odds ratio ( OR ) for having been previously diagnosed with IDA between cases and controls.We further analyzed the association between stroke and IDA by stroke subtype .
-RESULTS	Results showed that 3,685 study subjects ( 1.81 % ) had been diagnosed with IDA prior to the index date ; of those subjects , 1,268 ( 2.48 % ) were cases and 2,417 ( 1.58 % ) were controls ( p < 0.001 ) .
-RESULTS	Conditional logistic regression shows that the OR of having previously received an IDA diagnosis among cases was 1.49 ( 95 % CI : 1.39 ~ 1.60 ; p < 0.01 ) that of controls after adjusting for monthly income , geographic region , hypertension , diabetes , coronary heart disease , atrial fibrillation , heart failure , hyperlipidemia , tobacco use disorder , and alcohol abuse/alcohol dependency syndrome .
-RESULTS	Furthermore , the adjusted OR of prior IDA for cases with ischemic stroke was found to be 1.45 ( 95 % CI : 1.34 ~ 1.58 ) compared to controls .
-RESULTS	However , we did not find any significant relationship between IDA and subarachnoid/intracerebral hemorrhage even adjusting for other confounding factors ( OR = 1.17 , 95 % CI = 0.97 ~ 1.40 ) .
-CONCLUSIONS	There is a significant association between prior IDA and ischemic stroke .
-
-###24886398
-BACKGROUND	Fatigue is one of the most common and debilitating symptoms of multiple sclerosis ( MS ) .
-BACKGROUND	The aim was to evaluate the effectiveness at 1-year follow-up of a manualised group-based programme ( ` FACETS ' ) for managing MS-fatigue .
-METHODS	One-year follow-up of a pragmatic multi-centre randomised controlled trial .
-METHODS	People with MS and significant fatigue were randomised to FACETS plus current local practice ( FACETS ) or current local practice alone ( CLP ) , using concealed computer-generated randomisation .
-METHODS	Participant blinding was not possible .
-METHODS	Primary outcome measures were fatigue severity ( Global Fatigue Severity subscale of the Fatigue Assessment Instrument ) , self-efficacy ( MS-Fatigue Self-Efficacy ) and disease-specific quality of life ( MS Impact Scale ) .
-RESULTS	Between May 2008 and November 2009 , 164 participants were randomised .
-RESULTS	Primary outcome data were available at 1year for 131 ( 80 % ) .
-RESULTS	The benefits demonstrated at 4-months in the FACETS arm for fatigue severity and self-efficacy largely persisted , with a slight reduction in standardised effect sizes ( SES ) ( -0.29 , p = 0.06 and 0.34 , p = 0.09 , respectively ) .
-RESULTS	There was a significant difference on the MS Impact Scale favouring FACETS that had not been present at 4-months ( SES -0.24 , p = 0.046 ) .
-RESULTS	No adverse events were reported .
-CONCLUSIONS	Improvements in fatigue severity and self-efficacy at 4-months follow-up following attendance of FACETS were mostly sustained at 1year with additional improvements in MS impact .
-CONCLUSIONS	The FACETS programme provides modest long-term benefits to people with MS-fatigue .
-BACKGROUND	ISRCTN76517470 .
-
-###25379845
-OBJECTIVE	To determine whether regional hyperthermia ( RHT ) in addition to chemotherapy improves local tumor control after macroscopically complete resection of abdominal or retroperitoneal high-risk sarcomas .
-BACKGROUND	Within the prospectively randomized EORTC 62961 phase-III trial , RHT and systemic chemotherapy significantly improved local progression-free survival ( LPFS ) and disease-free survival ( DFS ) in patients with abdominal and extremity sarcomas .
-BACKGROUND	That trial included macroscopically complete and R2 resections .
-METHODS	A subgroup analysis of the EORTC trial was performed and long-term survival determined .
-METHODS	From 341 patients , 149 ( median age 52 years , 18-69 ) were identified with macroscopic complete resection ( R0 , R1 ) of abdominal and retroperitoneal soft-tissue sarcomas ( median diameter 10 cm , G2 48.3 % , G3 51.7 % ) .
-METHODS	Seventy-six patients were treated with EIA ( etoposide , ifosfamide , doxorubicin ) + RHT ( 5 cycles : 69.7 % ) versus 73 patients receiving EIA alone ( 5 cycles : 52.1 % , P = 0.027 ) .
-METHODS	LPFS and DFS as well as overall survival were determined .
-RESULTS	RHT and systemic chemotherapy significantly improved LPFS ( 56 % vs 45 % after 5 years , P = 0.044 ) and DFS ( 34 % vs 27 % after 5 years , P = 0.040 ) .
-RESULTS	Overall survival was not significantly improved in the RHT group ( 57 % vs 55 % after 5 years , P = 0.82 ) .
-RESULTS	Perioperative morbidity and mortality were not significantly different between groups .
-CONCLUSIONS	In patients with macroscopically complete tumor resection , RHT in addition to chemotherapy resulted in significantly improved local tumor control and DFS without increasing surgical complications .
-CONCLUSIONS	Within a multimodal therapeutic concept for abdominal and retroperitoneal high-risk sarcomas , RHT is a treatment option beside radical surgery and should be further evaluated in future trials .
-
-###25022108
-OBJECTIVE	To explore the therapeutic effect of acupuncture for hypertensive cerebral hemorrhage at the early stage .
-METHODS	Fifty-four cases of small-amount cerebral hemorrhage were randomized into an acupuncture group and a conventional treatment group , 27 cases in each one .
-METHODS	In the conventional treatment group , special care , oxygen therapy , nerve nutrition and symptomatic support were applied .
-METHODS	In necessary , dehydrant and hypotensive drugs were prescribed for antihypertension , or surgery was given .
-METHODS	In the acupuncture group , on the basis of the treatment as the control group , acupuncture was applied at Quchi ( LI 11 ) , Neiguan ( PC 6 ) , Zusanli ( ST 36 ) , Sanyinjiao ( SP 6 ) and Taichong ( LR 3 ) .
-METHODS	Acupuncture was given at the admission , 4 h , 6 h and 12 h after disease onset respectively .
-METHODS	Blood pressure was monitored in the whole procedure .
-METHODS	6 h and 24 h after disease onset , the cranial CT was re-examined .
-METHODS	Systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , hematoma volume and neurological deficit score were compared at different time points between the two groups .
-RESULTS	( 1 ) Blood pressure : from the admission to 12 h after disease onset , SBP , DBP and MAP were increased apparently in the conventional treatment group and increased slightly in the acupuncture group .
-RESULTS	The differences in SBP [ ( 164.3 + / - 21.6 ) mmHg vs ( 158.6 + / - 21.5 ) mmHg ] and MAP [ ( 113.4 + / - 4.9 ) mmHg vs ( 106.7 + / - 6.1 ) mmHg ] were significant between the two groups ( both P < 0.05 ) .
-RESULTS	From 12 h to 24 h after disease onset , compared with the conventional treatment group , SBP and MAP were decreased apparently in the acupuncture group [ ( 147.3 + / - 21.6 ) mmHg vs ( 158.4 + / - 23.5 ) mmHg , ( 97.2 + / - 5.3 ) mmHg vs ( 106.6 + / - 5.1 ) mmHg , both P < 0.05 ) ] .
-RESULTS	( 2 ) Hematoma volume : from the admission to 6 h after disease onset , the volume was increased by ( 4.15 + / - 0.73 ) mL in the convertional treatment group and ( 2.67 + / - 0.33 ) mL in the acupuncture group , indicating the significant difference in comparison ( P < 0.05 ) .
-RESULTS	From the admission to 24 h after disease onset , it was increased by ( 5.57 + / - 1.26 ) mL in the convertional treatment group and ( 3.14 + / - 1.18 ) mL in the acupuncture group , indicating the significant difference in comparison ( P < 0.05 ) .
-RESULTS	( 3 ) Neurological deficit score : the score was increasing gradually in first 3 days after disease onset in the two groups .
-RESULTS	The score ( 38.39 + / - 6.84 ) in the acupuncture group on the first day was different significantly as compared with that ( 42.37 + / - 7.46 ) in the conventional treatment group ( P < 0.05 ) .
-RESULTS	On the 10th days , the score ( 24.68 + / - 5.42 ) in the acupuncture group was different significantly from that ( 29.74 + / - 7.36 ) in the convertional treatment group ( P < 0.05 ) .
-CONCLUSIONS	There is no peak of blood pressure rising , and the continuous hemorrhagic volume is less in 24 h and neurological deficit score is improved in the acupuncture group .
-CONCLUSIONS	Acupuncture brings the positive significance in the treatment of cerebral hemorrhage at the early stage .
-
-###24622667
-BACKGROUND	We compared stepwise addition of bolus insulin with a full basal-bolus regimen in patients with type 2 diabetes inadequately controlled on basal insulin plus oral antidiabetic drugs .
-METHODS	The FullSTEP study was a phase 4 , 32-week , randomised , open-label , two-arm , parallel-group , multinational , treat-to-target , non-inferiority trial done at 150 sites across seven countries to assess the effectiveness of a stepwise dosing approach versus a basal-bolus regimen .
-METHODS	In this trial , 401 patients ( mean age 598 years [ SD 93 ] ; HbA1c 79 % [ 63 mmol/mol ] ; mean diabetes duration 126 years [ SD 80 ] ) were block randomised ( ratio 1:1 ) to receive either stepwise treatment or full basal-bolus treatment .
-METHODS	Patients in the basal-bolus group received insulin aspart before every meal throughout the trial .
-METHODS	Patients in the stepwise group received one bolus dose with the largest meal , with additional insulin aspart doses before the next largest meal added to their regimen at 11 weeks and 22 weeks if HbA1c remained at 7 % or higher .
-METHODS	The primary outcome was non-inferiority of stepwise addition of bolus insulin versus complete basal-bolus therapy , as assessed by change in HbA1c from baseline to 32 weeks ( non-inferiority margin of 04 % ) .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT01165684 .
-RESULTS	The study was started on Oct 27 , 2010 , and completed on April 25 , 2012 .
-RESULTS	After 32 weeks , HbA1c change from baseline was -098 % ( 95 % CI -109 to -087 ) for the stepwise group and -112 % ( -123 to -100 ) for the basal-bolus group ; mean treatment difference 014 ( 95 % CI -002 to 030 ) , non-significant ( p = 00876 ) .
-RESULTS	Fewer hypoglycaemic episodes occurred in the stepwise group than in the basal-bolus group ( rate ratio 058 [ 95 % CI 045 to 075 ] ; p < 00001 ) .
-RESULTS	Treatment-emergent adverse events did not differ between the two treatment groups .
-RESULTS	The most frequently reported treatment-emergent adverse event were nasopharyngitis , influenza , diarrhoea , headache , peripheral oedema , and wrong drug given .
-RESULTS	Three participants died : two before randomisation and one in the basal-bolus group ( due to severe acute myocardial infarction and respiratory tract inflammation ) .
-CONCLUSIONS	Stepwise prandial insulin intensification provides glycaemic control non-inferior to a full basal-bolus regimen after 32 weeks , with significantly lower hypoglycaemia risk and better patient satisfaction .
-BACKGROUND	Novo Nordisk .
-
-###24352340
-OBJECTIVE	RP is a reversible vasoconstriction of digital arteries that causes pain and skin discoloration .
-OBJECTIVE	This study compared the efficacy of the new phosphodiesterase type 5 inhibitor udenafil with that of the calcium channel blocker amlodipine in the treatment of secondary RP .
-METHODS	A total of 29 patients with secondary RP associated with connective tissue diseases were enrolled in this double-blind , randomized , cross-over study .
-METHODS	The patients were randomized to receive udenafil 100 mg/day or amlodipine 10 mg/day for 4 weeks .
-METHODS	After a washout period they were crossed over to the other drug for another 4 weeks .
-METHODS	The primary outcome was RP frequency before and after treatment .
-METHODS	The secondary outcomes were RP condition scores , RP duration , number of digital ulcers , HAQ , physician global assessment and digital artery flow before and after treatment .
-RESULTS	Amlodipine and udenafil both decreased the rate of RP attack significantly .
-RESULTS	The drugs did not differ in terms of RP frequency or any of the secondary outcomes except for digital blood flow ; udenafil improved it significantly better than amlodipine ( P = 0.021 ) .
-RESULTS	Udenafil was well tolerated without serious adverse effects .
-CONCLUSIONS	Udenafil and amlodipine have comparable efficacy in improving RP attacks .
-CONCLUSIONS	In addition , udenafil improves the blood flow in digital arteries compared with amlodipine .
-BACKGROUND	www.clinicaltrials.gov , protocol number NCT01280266 .
-
-###24622930
-OBJECTIVE	This study aimed at comparing the development of tricuspid and mitral regurgitation between the right ventricular outflow tract ( RVOT ) and right ventricular apex ( RVA ) pacing .
-METHODS	We prospectively enrolled 164 patients for permanent pacemaker implantation due to sick sinus syndrome or atrioventricular block and randomly divided them into two equal groups to receive either RVOT or RVA pacing .
-METHODS	Patients with heart failure or valvular disease were excluded .
-METHODS	The post-procedural echocardiographic evaluations were performed 1year after the pre-procedural echocardiography , and the results were compared with respect to the development of mitral and tricuspid regurgitation and probable changes in the ejection fraction ( EF ) .
-RESULTS	Age , gender , pacing mode , and baseline cardiac rhythm did not significantly differ between the RVOT and RVA pacing groups .
-RESULTS	The incidence of mitral regurgitation was significantly higher in the RVA group ( p = 0.03 ) , but the incidence of tricuspid regurgitation was similar in both groups .
-RESULTS	There was a trend toward less tricuspid regurgitation in the RVOT group ; however , it was not statistically significant .
-RESULTS	The mean EF was not significantly different between the study groups .
-CONCLUSIONS	It seems that the incidence of mitral regurgitation in RVA pacing is significantly higher than that in RVOT pacing .
-CONCLUSIONS	The formation of tricuspid regurgitation needs to be discussed in the future .
-BACKGROUND	IRCT201103146061N1 .
-
-###24325695
-OBJECTIVE	To investigate the impact of using paclitaxel-coated balloons ( PCB ) on outcome after post-angioplasty dissection in femoropopliteal arteries .
-METHODS	The angiograms obtained in the THUNDER study ( ClinicalTrials.gov identifier NCT00156624 ) were analyzed to compare degrees of dissection and angiographic parameters between the control ( uncoated balloons , n = 43 ) and treatment ( PCBs , n = 43 ) groups before and after the intervention and at 6-month follow-up .
-METHODS	Furthermore , target lesion revascularizations ( TLR ) were documented up to 2 years .
-RESULTS	In each group , 24 ( 56 % ) patients had a dissection after the intervention .
-RESULTS	At the 6-month follow-up , patients with dissection of any grade after treatment with PCBs had significantly less late lumen loss ( 0.4 mm ) than patients with dissection after treatment with uncoated balloons ( 1.9 mm , p = 0.001 ) and a lower degree of stenosis ( 20 % vs. 51 % , respectively ; p = 0.003 ) .
-RESULTS	Patients with severe dissection ( grades C , D , or E ) especially seemed to benefit from the PCBs , with late lumen loss of 0.4 mm vs. 2.4 mm for controls ( p = 0.05 ) .
-RESULTS	The binary restenosis rate was also markedly lower in the PCB group ( 20 % ) than in the uncoated group ( 55 % , p = 0.02 ) .
-RESULTS	In the 2-year follow-up , TLR was performed in 56 % of patients in the control group compared to 10 % of patients in the PCB group ( p = 0.002 ) .
-CONCLUSIONS	The results of this subgroup analysis suggest that patients with dissection following treatment with a paclitaxel-coated balloon have a very acceptable outcome and stent implantation is not necessary as long as the dissection does not result in acute flow limitation .
-
-###24374088
-OBJECTIVE	To examine whether mindfulness-based cognitive therapy ( MBCT ) would enhance attenuated amplitudes of event-related potentials ( ERPs ) indexing performance monitoring biomarkers of attention-deficit/hyperactivity disorder ( ADHD ) .
-METHODS	Fifty adult ADHD patients took part in a randomised controlled study investigating ERP and clinical measures pre-to-post MBCT .
-METHODS	Twenty-six patients were randomly allocated to MBCT , 24 to a wait-list control .
-METHODS	Main outcome measures included error processing ( ERN , Pe ) , conflict monitoring ( NoGo-N2 ) , and inhibitory control ( NoGo-P3 ) ERPs concomitant to a continuous performance task ( CPT-X ) .
-METHODS	Inattention and hyperactivity-impulsivity ADHD symptoms , psychological distress and social functioning , and mindfulness skills were also assessed .
-RESULTS	MBCT was associated with increased Pe and NoGo-P3 amplitudes , coinciding with reduced ` hyperactivity/impulsivity ' and ` inattention ' symptomatology .
-RESULTS	Specific to the MBCT ; enhanced Pe amplitudes correlated with a decrease in hyperactivity/impulsivity symptoms and increased ` act-with-awareness ' mindfulness skill , whereas , enhanced P3 correlated with amelioration in inattention symptoms .
-CONCLUSIONS	MBCT enhanced ERP amplitudes associated with motivational saliency and error awareness , leading to improved inhibitory regulation .
-CONCLUSIONS	MBCT suggests having comparable modulation on performance monitoring ERP amplitudes as pharmacological treatments .
-CONCLUSIONS	Further study and development of MBCT as a treatment for ADHD is warranted , in addition to its potential scope for clinical applicability to broader defined externalising disorders and clinical problems associated with impairments of the prefrontal cortex .
-
-###24524605
-OBJECTIVE	To investigate the long-term effect of bosentan on outcome in patients after Fontan operation .
-METHODS	Patients after Fontan surgery were randomly divided into bosentan group ( B , n = 16 ) and control group ( C , n = 23 ) .
-METHODS	Bosentan was applied within 7 days after Fontan surgery as follows : at the first month , 7.8125 mg Bid for patients with body weight 10 kg ; 15.625 mg Bid for patients with body weight between 10-20 kg ; 31.25 mg Bid for patients with body weight 20-30 kg and 62.5 mg Bid for patients with body weight > 30 kg .
-METHODS	At the second month , the bosentan dose was doubled and Bosentan therapy was continued for more than 1 year .
-METHODS	Group C did n't take drugs affecting pulmonary artery pressure .
-METHODS	All patients were followed up for 2 years and incidence of mortality , protein losing enteropathy , pulmonary arteriovenous fistulae , 6-minute walk test , heart function were compared between the two groups .
-RESULTS	After 2 years , mortality tended to be lower in group B compared to group C [ 6.25 % ( 1/16 ) vs. 21.8 % ( 5/23 ) , P > 0.05 ] .
-RESULTS	Incidence of pulmonary arteriovenous fistulae and protein losing enteropathy were significantly lower in group B than in group C ( 6.25 % vs. 34.78 % , P = 0.01 ; 6.25 % vs. 39.13 % , P = 0.02 , respectively ) .
-RESULTS	The results of 6-minute walk test [ ( 485 44 ) m vs. ( 302 183 ) m ] and heart function in group B ( 3 NYHA III/IV patients in group B vs. 14 NYHA III/IV patients in group C , all P < 0.05 ) were all better than group C.
-RESULTS	The concentrations of vasoactive factors such as brain natriuretic peptide ( BNP , 279.07 128.17 vs. 457.67 221.30 ) , endothelin ( ET , 3.30 0.61 vs. 4.98 1.24 ) and thromboxane ( TXA2 , 97.2 24.0 vs. 163.22 24.4 ) were also significantly lower in group B than in group C ( all P < 0.05 ) .
-RESULTS	Prostacyclin ( PGI2 ) level and incidence of arrhythmias were similar between the two groups .
-RESULTS	There was no thrombotic event in both groups during follow up .
-CONCLUSIONS	Bosentan trerapy in patients post Fontan operation could reduce the incidence of pulmonary arteriovenous fistulae and protein losing enteropathy and improve heart function .
-
-###24619628
-BACKGROUND	In schizophrenia , the presence of certain cognitive biases has been established .
-BACKGROUND	Informed by this , metacognitive training ( MCT ) has been developed for schizophrenia .
-BACKGROUND	There is increasing evidence of its effectiveness with some patients , but its applicability to dangerous patients has not yet been demonstrated .
-OBJECTIVE	Our aim was to test the feasibility of a randomised controlled trial ( RCT ) of MCT for patients in a high-security hospital setting .
-METHODS	Twenty of 33 eligible and selected male in-patients with schizophrenia and a history of violence were randomised pairwise to eight sessions of MCT or treatment as usual .
-METHODS	Symptom severity and reasoning , according to the jumping to conclusions paradigm , were measured before , immediately after treatment , and 3 and 6months later .
-RESULTS	Men in both groups completed the trial , and those in the MCT arm , almost all of the group sessions .
-RESULTS	The MCT arm had a significant advantage in improvement of ` suspiciousness ' , greatest at 3months , but then declining .
-RESULTS	No significant improvement in reasoning ability was achieved .
-CONCLUSIONS	Metacognitive training showed sufficient promise in this group for a full trial to be worthwhile , and the feasibility of an RCT methodology , even in a secure hospital , was established .
-CONCLUSIONS	The fact that the improvements faded during follow-up suggests that a useful modification to the treatment would be lengthening the protocol , repeating it , or both .
-
-###24423921
-BACKGROUND	We evaluated week-on/week-off axitinib dosing plus chemotherapy in patients with gastrointestinal tumours , including tumour thymidine uptake by fluorine-18 3 ' - deoxy-3 ' - fluorothymidine positron emission tomography ( ( 18 ) FLT-PET ) .
-METHODS	During a lead-in period , patients received twice daily ( b.i.d. ) axitinib 7 mg ( n = 3 ) or 10 mg ( n = 18 ) for 7 days followed by a 7-day dosing interruption ; serial ( 18 ) FLT-PET scans were performed before day 1 and on days 7 , 10 , and 14 .
-METHODS	Axitinib plus FOLFIRI or FOLFOX was then administered in 2-week cycles ; axitinib was interrupted on day 10 of each cycle for 7 days .
-RESULTS	The maximum tolerated dose of axitinib was 10 mg b.i.d. , in a week-on/week-off schedule , combined with FOLFIRI or FOLFOX .
-RESULTS	Common all-causality grade 3 adverse events were neutropenia ( 38 % ) , hypertension ( 33 % ) , and fatigue ( 29 % ) .
-RESULTS	Of 21 patients , 2 ( 10 % ) had a partial response and 12 ( 57 % ) had stable disease .
-RESULTS	Following 7 days of continuous axitinib dosing , tumour ( 18 ) FLT uptake decreased -49 % from baseline and recovered to -28 % and -17 % from baseline , respectively , after 3 and 7 days of axitinib interruption .
-CONCLUSIONS	Axitinib administered in a week-on/week-off schedule combined with FOLFIRI or FOLFOX is supported by ( 18 ) FLT-PET data and was well tolerated in patients with gastrointestinal tumours .
-
-###24662210
-BACKGROUND	Classification schemas for low back pain ( LBP ) , such as the Treatment-Based Classification and the Movement System Impairment , use common clinical features to subgroup patients with LBP and are purported to improve treatment outcomes .
-OBJECTIVE	To assess if providing matched treatments based on patient-specific clinical features led to superior treatment outcomes compared with an unmatched treatment for subjects with chronic recurrent LBP .
-METHODS	This study is a randomized controlled trial .
-METHODS	Subjects ( n = 124 ) with LBP ( 12 months ) with or without recurrences underwent a standardized clinical examination to group them into one of two strata : ineligible or eligible for stabilization exercises based on the Treatment-Based Classification schema .
-METHODS	Subjects underwent additional clinical tests to assign them to one of the five possible Movement System Impairment categories .
-METHODS	Questionnaires were collected electronically at Week 0 ( before treatment ) , Week 7 ( after the 6-week 1-hour treatment sessions ) , and 12 months .
-METHODS	Using the Oswestry disability index ( 0-100 ) and the Numeric Pain Rating Scale ( 0-10 ) , the primary analysis was performed using the intention-to-treat principle .
-METHODS	Secondary outcomes included fear-avoidance beliefs and psychosocial work-related and general health status .
-METHODS	After subjects were categorized based on their particular clinical features using both the Treatment-Based Classification and Movement System Impairment schemas , they were randomized into one of two treatments using a 3:1 ratio for matched or unmatched treatments .
-METHODS	The treatments were trunk stabilization exercise or Movement System Impairment-directed exercises .
-RESULTS	Of the patients allocated to treatment for this study , 76 received a matched treatment and 25 received an unmatched treatment .
-RESULTS	After treatment , both groups showed a statistically significant improvement in the primary outcome measures and almost all the secondary measures ; however , the matched treatment group did not demonstrate superior outcomes at Week 7 or 12 months , except on one of the secondary measures ( Graded Chronic Pain Scale [ Disability Scale ] ) ( p = .01 ) .
-CONCLUSIONS	Providing a matched treatment based on either the Treatment-Based Classification or the Movement System Impairment classification schema did not improve treatment outcomes compared with an unmatched treatment for patients with chronic LBP , except on one secondary disability measure .
-
-###25348807
-BACKGROUND	Wound infiltration at the end of carotid endarterectomy under general anaesthesia is a simple technique that can be delegated to the surgeon .
-BACKGROUND	It was hypothesised that this technique could improve early post-operative analgesia by reducing the need for post-operative opioids .
-METHODS	Forty patients underwent carotid endarterectomy under general anaesthesia with desflurane and remifentanil supplemented with morphine for post-operative analgesia .
-METHODS	In a prospective double-blinded randomised study , patients were allocated pre-operatively to receive either subcutaneous infiltration of both wound edges with 20 ml of 0.75 % ropivacaine or infiltration with isotonic saline .
-METHODS	The primary outcome was morphine consumption while in the post-anaesthesia care unit ( PACU ) .
-METHODS	Pain scores at rest and movement , sedation , and patient satisfaction were the other main outcomes used to assess post-operative analgesia .
-RESULTS	The median dose of morphine administered in the PACU was 2 mg [ 0-3 ] in the ropivacaine vs. 4 mg [ 3-6 ] in the placebo group ( P = 0.0004 , Mann-Whitney 's test ) .
-RESULTS	Pain at rest and at movement was lower in the ropivacaine group throughout observation in the PACU .
-RESULTS	No difference was found for both pain and opioid consumption after discharge from the PACU or for patient satisfaction .
-RESULTS	Sedative events in the early post-operative period were less frequent in the ropivacaine group .
-CONCLUSIONS	Local anaesthetic wound infiltration performed before closure reduces the need for additional opioids , lowers the immediate post-operative pain and improves alertness .
-CONCLUSIONS	These results argue for the use of local infiltration anaesthesia for carotid endarterectomy .
-
-###24726032
-BACKGROUND	Venous thromboembolism is common in patients with cancer and requires anticoagulation with low molecular weight heparin .
-BACKGROUND	Current data informs anticoagulation as far as six months , yet guidelines recommend anticoagulation beyond six months in patients who have locally advanced or metastatic cancer .
-BACKGROUND	This recommendation , based on expert consensus , has not been evaluated in a clinical study .
-BACKGROUND	ALICAT ( Anticoagulation Length in Cancer Associated Thrombosis ) is a feasibility study to identify the most clinically and cost effective length of anticoagulation with low molecular weight heparin in the treatment of cancer associated thrombosis .
-METHODS	ALICAT is a randomized multi-centre phase two mixed-methods study with three components : a randomized controlled trial , embedded qualitative study and a survey investigating pathways of care .
-METHODS	The randomized controlled trial will compare ongoing low molecular weight heparin treatment for cancer-associated thrombosis versus cessation of low molecular weight heparin at six months treatment ( current licensed practice ) in patients with locally advanced or metastatic cancer .
-METHODS	The embedded qualitative study will include focus groups with clinicians to investigate attitudes to recruiting to the study , identify the challenges of progressing to a full randomized controlled trial , and also semi-structured interviews with patients and relatives/carers to explore their attitudes towards participating in the study and potential barriers and concerns to participation .
-METHODS	Finally , a UK wide survey exercise will be undertaken to develop a classification and enumeration system for the cancer associated thrombosis models and pathways of care .
-CONCLUSIONS	There is a lack of evidence determining the length of anticoagulation for patients with cancer associated thrombosis and subsequently treatment length varies .
-CONCLUSIONS	The ALICAT study will consider the feasibility of recruiting patients to a phase three trial .
-BACKGROUND	Current Controlled Trials ISRCTN37913976 .
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-###25794890
-BACKGROUND	For women with hormone receptor-positive , operable breast cancer , surgical oophorectomy plus tamoxifen is an effective adjuvant therapy .
-BACKGROUND	We conducted a phase III randomized clinical trial to test the hypothesis that oophorectomy surgery performed during the luteal phase of the menstrual cycle was associated with better outcomes .
-METHODS	Seven hundred forty premenopausal women entered a clinical trial in which those women estimated not to be in the luteal phase of their menstrual cycle for the next one to six days ( n = 509 ) were randomly assigned to receive treatment with surgical oophorectomy either delayed to be during a five-day window in the history-estimated midluteal phase of the menstrual cycles , or in the next one to six days .
-METHODS	Women who were estimated to be in the luteal phase of the menstrual cycle for the next one to six days ( n = 231 ) were excluded from random assignment and received immediate surgical treatments .
-METHODS	All patients began tamoxifen within 6 days of surgery and continued this for 5 years .
-METHODS	Kaplan-Meier methods , the log-rank test , and multivariable Cox regression models were used to assess differences in five-year disease-free survival ( DFS ) between the groups .
-METHODS	All statistical tests were two-sided .
-RESULTS	The randomized midluteal phase surgery group had a five-year DFS of 64 % , compared with 71 % for the immediate surgery random assignment group ( hazard ratio [ HR ] = 1.24 , 95 % confidence interval [ CI ] = 0.91 to 1.68 , P = .18 ) .
-RESULTS	Multivariable Cox regression models , which included important prognostic variables , gave similar results ( aHR = 1.28 , 95 % CI = 0.94 to 1.76 , P = .12 ) .
-RESULTS	For overall survival , the univariate hazard ratio was 1.33 ( 95 % CI = 0.94 to 1.89 , P = .11 ) and the multivariable aHR was 1.43 ( 95 % CI = 1.00 to 2.06 , P = .05 ) .
-RESULTS	Better DFS for follicular phase surgery , which was unanticipated , proved consistent across multiple exploratory analyses .
-CONCLUSIONS	The hypothesized benefit of adjuvant luteal phase oophorectomy was not shown in this large trial .
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-###24239662
-OBJECTIVE	The goal of this study was to investigate the differential efficacy of clopidogrel or aspirin monotherapy according to smoking status in patients with atherosclerotic vascular disease .
-BACKGROUND	Smoking enhances clopidogrel-induced platelet inhibition , which may explain the higher relative benefit among smokers observed in trials evaluating dual antiplatelet therapy .
-BACKGROUND	Whether smoking has an impact on clinical outcomes in patients requiring a single antiplatelet agent remains unknown .
-METHODS	This was a post-hoc analysis of the CAPRIE ( Clopidogrel Versus Aspirin in Patients at Risk of Ischemic Events ) trial that compared clopidogrel and aspirin monotherapy in patients ( N = 19,184 ) with atherosclerotic vascular disease .
-RESULTS	Current smokers ( n = 5,688 ) had an increased risk of ischemic events compared with never smokers ( n = 4,135 ; hazard ratio [ HR ] : 1.24 [ 95 % confidence interval ( CI ) : 1.08 to 1.42 ] ) and ex-smokers ( n = 9,381 ; HR : 1.32 [ 95 % CI : 1.18 to 1.47 ] ) ( p < 0.001 ) .
-RESULTS	Clopidogrel was associated with a reduction in ischemic events among current smokers ( 8.3 % vs. 10.8 % ; HR : 0.76 [ 95 % CI : 0.64 to 0.90 ] ) , whereas no benefit over aspirin was seen in the combined group of ex-smokers/never-smoked patients ( 10.4 % vs. 10.6 % ; HR : 0.99 [ 95 % CI : 0.89 to 1.10 ] ; p = 0.01 for interaction ) .
-RESULTS	Among current smokers , clopidogrel also reduced myocardial infarction , vascular death , and death from any cause compared with aspirin .
-RESULTS	No interaction between smoking status and study treatment was observed for bleeding events .
-CONCLUSIONS	In a post-hoc analysis of the CAPRIE population , current smokers appeared to have enhanced benefit with clopidogrel therapy for secondary prevention compared with aspirin .
-CONCLUSIONS	These results should be considered hypothesis generating for future prospective studies assessing the impact of specific platelet-inhibiting strategies according to smoking status .
-
-###24850938
-OBJECTIVE	To evaluate the efficacy of faculty-led problem-based learning ( PBL ) vs online simulated-patient case in fourth-year ( P4 ) pharmacy students .
-METHODS	Fourth-year pharmacy students were randomly assigned to participate in either online branched-case learning using a virtual simulation platform or a small-group discussion .
-METHODS	Preexperience and postexperience student assessments and a survey instrument were completed .
-RESULTS	While there were no significant differences in the preexperience test scores between the groups , there was a significant increase in scores in both the virtual-patient group and the PBL group between the preexperience and postexperience tests .
-RESULTS	The PBL group had higher postexperience test scores ( 74.811.7 ) than did the virtual-patient group ( 66.513.6 ) ( p = 0.001 ) .
-CONCLUSIONS	The PBL method demonstrated significantly greater improvement in postexperience test scores than did the virtual-patient method .
-CONCLUSIONS	Both were successful learning methods , suggesting that a diverse approach to simulated patient cases may reach more student learning styles .
-
-###25638793
-BACKGROUND	Hamilton depression rating scale ( HAMD ) subscales provide an economic alternative for the full scale ; however , their ability to detect onset of improvement in the early course of treatment ( EI ) has not yet been researched .
-BACKGROUND	The present study investigated in patients with major depression ( MD ) whether the subscales are a comparable option to predict treatment remission in the early course of treatment .
-METHODS	Based on data from 210 MD patients of a 6-week randomised , placebo-controlled trial comparing mirtazapine ( MIR ) and paroxetine ( PAR ) , the discriminative and predictive validity of EI for ( stable ) remission at treatment end was evaluated for seven subscales and the HAMD17 in the total and in treatment subgroups ( MIR vs. PAR ) .
-METHODS	Receiver operating characteristics ( ROC ) curves ( at week 2 ) and the Clinical Global Impression scales ( CGI ) ( at study endpoint ) were used to validate the 20 % EI criterion for the subscales .
-RESULTS	Only the Evans6 and Toronto7 subscale had almost the same predictive value as the HAMD17 ( e.g. , sensitivities stable remission Evans6/Toronto7 : 96/95 % vs. 96 % HAMD17 ) .
-RESULTS	The optimal cut-off for EI to predict remission was just below 20 % for most subscales and slightly over 20 % for stable remission .
-CONCLUSIONS	Study sample representativeness , non-independence of subscales , missing external validation criterion , lack of control group .
-CONCLUSIONS	The Evans6 and Toronto7 subscales are valuable alternatives in situations , where economic aspects play a larger role .
-CONCLUSIONS	A sum score reduction of 20 % as definition for EI seems also appropriate for the HAMD subscales , in the total as well as in the antidepressant subgroups .
-
-###24690329
-OBJECTIVE	To evaluate the effectiveness and safety of a T-piece resuscitator compared with a self-inflating bag for providing mask ventilation to newborns at birth .
-METHODS	Newborns at 26 weeks gestational age receiving positive-pressure ventilation at birth were included in this multicenter cluster-randomized 2-period crossover trial .
-METHODS	Positive-pressure ventilation was provided with either a self-inflating bag ( self-inflating bag group ) with or without a positive end-expiratory pressure valve or a T-piece with a positive end-expiratory pressure valve ( T-piece group ) .
-METHODS	Delivery room management followed American Academy of Pediatrics and International Liaison Committee on Resuscitation guidelines .
-METHODS	The primary outcome was the proportion of newborns with heart rate ( HR ) 100 bpm at 2 minutes after birth .
-RESULTS	A total of 1027 newborns were included .
-RESULTS	There was no statistically significant difference in the incidence of HR100 bpm at 2 minutes after birth between the T-piece and self-inflating bag groups : 94 % ( 479 of 511 ) and 90 % ( 466 of 516 ) , respectively ( OR , 0.65 ; 95 % CI , 0.41-1 .05 ; P = .08 ) .
-RESULTS	A total of 86 newborns ( 17 % ) in the T-piece group and 134 newborns ( 26 % ) in the self-inflating bag group were intubated in the delivery room ( OR , 0.58 ; 95 % CI , 0.4-0 .8 ; P = .002 ) .
-RESULTS	The meanSD maximum positive inspiratory pressure was 262 cm H2O in the T-piece group vs 285 cm H2O in the self-inflating bag group ( P < .001 ) .
-RESULTS	Air leaks , use of drugs/chest compressions , mortality , and days on mechanical ventilation did not differ significantly between groups .
-CONCLUSIONS	There was no difference between the T-piece resuscitator and a self-inflating bag in achieving an HR of 100 bpm at 2 minutes in newborns26 weeks gestational age resuscitated at birth .
-CONCLUSIONS	However , use of the T-piece decreased the intubation rate and the maximum pressures applied .
-
-###24325899
-OBJECTIVE	To compare operative time with use of THUNDERBEAT ( TB ) vs standard electrosurgery ( SES ) during laparoscopic radical hysterectomy and pelvic lymphadenectomy to treat gynecologic tumors .
-METHODS	Evidence obtained from a properly designed , randomized , controlled trial ( Canadian Task Force classification I ) .
-METHODS	Gynecologic Oncology Unit of the Catholic University of the Sacred Heart in Rome , Italy .
-METHODS	Fifty patients with early cervical cancer ( FIGO stages IA2 , IB1 , IIA < 2 cm ) or locally advanced cervical cancer ( FIGO stages IB2 , IIA > 2cm , IIB ) who received neoadjuvant treatment ( chemotherapy or radiochemotherapy ) and demonstrated a complete or partial clinical response and early stage endometrioid endometrial cancer ( FIGO stages IB , II ) were randomly assigned to undergo TB ( arm A ) or SES ( arm B ) .
-METHODS	Laparoscopic radical hysterectomy with bilateral pelvic lymphadenectomy , using an easily reproducible technique was performed .
-RESULTS	Fifty patients were available for analysis , with 25 women randomly assigned to TB ( arm A ) and 25 to SES ( arm B ) .
-RESULTS	The median operative time was 85 minutes for TB vs 115 minutes for SES ( p = .001 ) .
-RESULTS	At multivariate analysis , endometrial cancer ( p = .001 ) and TB ( p = .001 ) were independently associated with shorter operating time .
-RESULTS	No differences in perioperative outcomes and postoperative complications were observed between the 2 arms .
-RESULTS	Patients who underwent TB reported less postoperative pain , both at rest ( p = .005 ) and after the Valsalva maneuver ( p = .008 ) , with less additional analgesic therapy other than standard therapy required in patients who underwent SES ( p = .02 ) .
-CONCLUSIONS	TB is associated with shorter operative time and less postoperative pain than is the standard technique ( SES ) in patients with uterine cancer .
-
-###24638241
-OBJECTIVE	To evaluate the long-term efficacy of pain reduction by two dose-fractionation schedules for radiotherapy of painful shoulder syndrome .
-METHODS	Between February 2006 and February 2010 , 312evaluable patients were recruited for this prospective trial .
-METHODS	All patients received low-dose orthovoltage radiotherapy .
-METHODS	One course consisted of 6fractions in 3weeks .
-METHODS	In the case of insufficient pain remission after 6weeks , a second course was administered .
-METHODS	Patients were randomly assigned to one of two groups to receive single doses of either 0.5 or 1.0 Gy .
-METHODS	Endpoint was pain reduction .
-METHODS	Pain was measured before radiotherapy , as well as immediately after ( early response ) , 6weeks after ( delayed response ) and approximately 3years after ( long-term response ) completion of radiotherapy using a questionnaire-based visual analogue scale ( VAS ) and a comprehensive pain score ( CPS ) .
-RESULTS	Median follow-up was 35months ( range11-57 ) .
-RESULTS	The overall early , delayed and long-term response rates for all patients were 83 , 85 and 82 % , respectively .
-RESULTS	The mean VAS scores before treatment and those for early , delayed and long-term response in the 0.5 - and 1.0-Gy groups were 56.823.7 and 53.221.8 ( p = 0.16 ) ; 38.236.1 and 34.024.5 ( p = 0.19 ) ; 33.027.2 and 23.722.7 ( p = 0.04 ) and 27.925.8 and 32.126.9 ( p = 0.25 ) , respectively .
-RESULTS	The mean CPS values before treatment and those for early , delayed and long-term response were 9.73.0 and 9.52.7 ( p = 0.31 ) ; 6.13.6 and 5.43.6 ( p = 0.10 ) ; 5.33.7 and 4.13.7 ( p = 0.05 ) and 4.03.9 and 5.34.4 ( p = 0.05 ) , respectively .
-RESULTS	No significant differences in the quality of the long-term response were found between the 0.5 - and 1.0-Gy arms ( p = 0.28 ) .
-CONCLUSIONS	Radiotherapy is an effective treatment for the management of benign painful shoulder syndrome .
-CONCLUSIONS	For radiation protection reasons , the dose for a radiotherapy series should not exceed 3.0 Gy .
-
-###24548129
-OBJECTIVE	Management of recent-onset schizophrenia ( SZ ) and schizoaffective disorder ( SA ) is challenging owing to frequent insufficient response to antipsychotic agents .
-OBJECTIVE	This study aimed to test the efficacy and safety of the neurosteroid pregnenolone in patients with recent-onset SZ/SA .
-METHODS	Sixty out - and inpatients who met DSM-IV criteria for SZ/SA , with suboptimal response to antipsychotics were recruited for an 8-week , double-blind , randomized , placebo-controlled , two-center add-on trial , that was conducted between 2008 and 2011 .
-METHODS	Participants were randomized to receive either pregnenolone ( 50mg/day ) or placebo added on to antipsychotic medications .
-METHODS	The primary outcome measures were the Positive and Negative Symptoms Scale and the Assessment of Negative Symptoms scores .
-METHODS	Secondary outcomes included assessments of functioning , and side-effects .
-RESULTS	Analysis was by linear mixed model .
-RESULTS	Fifty-two participants ( 86.7 % ) completed the trial .
-RESULTS	Compared to placebo , adjunctive pregnenolone significantly reduced Positive and Negative Symptoms Scale negative symptom scores with moderate effect sizes ( d = 0.79 ) .
-RESULTS	Significant improvement was observed in weeks 6 and 8 of pregnenolone therapy among patients who were not treated with concomitant mood stabilizers ( armsvisitmood stabilizers ; P = 0.010 ) .
-RESULTS	Likewise , pregnenolone significantly reduced Assessment of Negative Symptoms scores compared to placebo ( d = 0.57 ) , especially on blunted affect , avolition and anhedonia domain scores .
-RESULTS	Other symptoms , functioning , and side-effects were not significantly affected by adjunctive pregnenolone .
-RESULTS	Antipsychotic agents , benzodiazepines and sex did not associate with pregnenolone augmentation .
-RESULTS	Pregnenolone was well tolerated .
-CONCLUSIONS	Thus , add-on pregnenolone reduces the severity of negative symptoms in recent-onset schizophrenia and schizoaffective disorder , especially among patients who are not treated with concomitant mood stabilizers .
-CONCLUSIONS	Further studies are warranted .
-
-###24758530
-BACKGROUND	Loneliness in older people is associated with poor health-related quality of life ( HRQoL ) .
-BACKGROUND	We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people .
-BACKGROUND	An internal pilot tested the feasibility of the trial and intervention .
-METHODS	Participants aged > 74years , with good cognitive function , living independently in one UK city were recruited through general practices and other sources , then randomised to : ( 1 ) 6weeks of short one-to-one telephone calls , followed by 12weeks of group telephone calls with up to six participants , led by a trained volunteer facilitator ; or ( 2 ) a control group .
-METHODS	The main trial required the recruitment of 248 participants in a 1-year accrual window , of whom 124 were to receive telephone befriending .
-METHODS	The pilot specified three success criteria which had to be met in order to progress the main trial to completion : recruitment of 68 participants in 95days ; retention of 80 % participants at 6months ; successful delivery of telephone befriending by local franchise of national charity .
-METHODS	The primary clinical outcome was the Short Form ( 36 ) Health Instrument ( SF-36 ) Mental Health ( MH ) dimension score collected by telephone 6months following randomisation .
-RESULTS	We informed 9,579 older people about the study .
-RESULTS	Seventy consenting participants were randomised to the pilot in 95days , with 56 ( 80 % ) providing valid primary outcome data ( 26 intervention , 30 control ) .
-RESULTS	Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators .
-RESULTS	The trial was closed early as a result .
-RESULTS	The mean 6-month SF-36 MH scores were 78 ( SD 18 ) and 71 ( SD 21 ) for the intervention and control groups , respectively ( mean difference , 7 ; 95 % CI , -3 to 16 ) .
-CONCLUSIONS	Recruitment and retention of participants to a definitive trial with a recruitment window of 1year is feasible .
-CONCLUSIONS	For the voluntary sector to recruit sufficient volunteers to match demand for telephone befriending created by trial recruitment would require the study to be run in more than one major population centre , and/or involve dedicated management of volunteers .
-BACKGROUND	ISRCTN28645428 .
-
-###24709931
-OBJECTIVE	To evaluate the effectiveness of an educational intervention to decrease pediatric emergency department ( PED ) visits and adverse care practices for upper respiratory infections ( URI ) among predominantly Latino Early Head Start ( EHS ) families .
-METHODS	Four EHS sites in New York City were randomized .
-METHODS	Families at intervention sites received 3 1.5-hour education modules in their EHS parent-child group focusing on URIs , over-the-counter medications , and medication management .
-METHODS	Standard curriculum families received the standard EHS curriculum , which did not include URI education .
-METHODS	During weekly telephone calls for 5 months , families reported URI in family members , care sought , and medications given .
-METHODS	Pre - and post-intervention knowledge-attitude surveys were also conducted .
-METHODS	Outcomes were compared between groups .
-RESULTS	There were 154 families who participated ( 76 intervention , 78 standard curriculum ) including 197 children < 4 years old .
-RESULTS	Families were primarily Latino and Spanish-speaking .
-RESULTS	Intervention families were significantly less likely to visit the PED when their young child ( age 6 to < 48 months ) was ill ( 8.2 % vs 15.7 % ; P = .025 ) .
-RESULTS	The difference remained significant on the family level ( P = .03 ) .
-RESULTS	These families were also less likely to use an inappropriate over-the-counter medication for their < 2-year-old child ( odds ratio , 0.29 ; 95 % confidence interval , 0.09-0 .95 ; 12.2 % vs 32.4 % , P = .034 ) and/or incorrect dosing tool for their < 4-year-old child ( odds ratio , 0.24 ; 95 % confidence interval , 0.08-0 .74 ; 9.8 % vs 31.1 % ; P < .01 ) .
-RESULTS	The mean difference in Knowledge-Attitude scores for intervention families was higher .
-CONCLUSIONS	A URI health literacy-related educational intervention embedded into EHS decreased PED visits and adverse care practices .
-
-###25439713
-BACKGROUND	The promising results of Schroth scoliosis-specific exercises for adolescent idiopathic scoliosis found in low-quality studies will be strengthened by confirmation in a randomised controlled trial .
-OBJECTIVE	1 .
-OBJECTIVE	Are Schroth exercises combined with standard care for 6 months more effective than standard care alone in improving radiographic and clinical outcomes for adolescents with idiopathic scoliosis ?
-OBJECTIVE	2 .
-OBJECTIVE	Will the outcomes of the control group ( who will be offered Schroth therapy delayed by 6 months ) improve after 6 months of Schroth therapy ?
-OBJECTIVE	3 .
-OBJECTIVE	Are the effects maintained 6 months after discontinuing the supervised intervention ?
-METHODS	This is an assessor-blinded and statistician-blinded randomised controlled trial with transfer of the controls to the exercise group after 6 months .
-METHODS	Two hundred and fifty-eight consecutive adolescents with idiopathic scoliosis , aged 10 to 16 years , treated with or without a brace , with curves between 10 and 45 deg Cobb and Risser sign 3 will be recruited from three scoliosis clinics .
-METHODS	Combined with standard care , the Schroth group will receive five individual training sessions , followed by weekly group classes and daily home exercises for 6 months .
-METHODS	Controls will only receive standard care consisting of observation or bracing , and will be offered Schroth therapy 6 months later .
-METHODS	Curve severity ( Cobb angle ) and vertebral rotation will be assessed from radiographs at baseline , 6 and 12 months .
-METHODS	Secondary clinical outcomes ( back muscle endurance , surface topography measures of posture , and self-reported perceived spinal appearance and quality of life ) will be assessed at baseline , and every 3 months until 1-year follow-up .
-METHODS	Data will be analysed using intention-to-treat linear mixed models .
-CONCLUSIONS	The results will demonstrate whether Schroth exercises combined with standard of care can improve outcomes in adolescents with idiopathic scoliosis .
-CONCLUSIONS	This study has potential to influence clinical practice worldwide , where exercises are not routinely prescribed for adolescents with idiopathic scoliosis .
-
-###24408401
-OBJECTIVE	Endogenous insulin secretion , measured by C-peptide area under the curve ( AUC ) , can be tested using both the glucagon stimulation test ( GST ) and the mixed-meal tolerance test ( MMTT ) .
-OBJECTIVE	This study compares these two stimulation methods using long-term data from patients newly diagnosed with type 1 diabetes or with latent autoimmune diabetes .
-METHODS	A recently completed phase 3 intervention study with DiaPep277 demonstrated improved glycemic control and a significant treatment effect of glucagon-stimulated C-peptide secretion .
-METHODS	Unexpectedly , MMTT failed to detect differences between the treated and control groups .
-METHODS	Data from 343 patients in two balanced-randomized , double-blind , placebo-controlled , parallel-group trials of DiaPep277 were used to compare and correlate between GST - and MMTT-derived C-peptide AUC .
-METHODS	Pearson 's correlations were calculated for absolute C-peptide AUC at baseline and 12 and 24 months and for long-term changes in AUC ( AUC ) .
-RESULTS	The absolute AUC values obtained at any single time point by the two tests were well correlated in both data sets ( r = 0.74-0 .9 ) .
-RESULTS	However , the correlations between the AUC were much weaker ( r = 0.39-0 .58 ) .
-RESULTS	GST-stimulated C-peptide secretion was stable over the fasting glucose range permitted for the test ( 4-11 .1 mmol/L ) , but MMTT-stimulated C-peptide secretion decreased over the same range , implying differences in sensitivity to glucose .
-CONCLUSIONS	Measurement of long-term changes in stimulated C-peptide , reflecting endogenous insulin secretion , during the course of intervention trials may be affected by the method of stimulation , possibly reflecting different sensitivities to the physiological status of the tested subject .
-
-###24984177
-BACKGROUND	The results of the Hypertension in the Very Elderly Trial showed positive benefits from blood pressure-lowering treatment in those aged 80 and over .
-METHODS	An analysis by the pre-specified subgroups [ age , sex , history of cardiovascular disease ( CVD ) and initial SBP ] was performed .
-METHODS	The Hypertension in the Very Elderly Trial was a randomized , double-blind , placebo-controlled trial of 3845 participants aged 80 and over with SBPs of 160-199 mmHg and diastolic pressures below 110 mmHg recruited from Europe , China , Australasia and Tunisia .
-METHODS	Active treatment was indapamide sustained-release 1.5 mg with the addition of perindopril 2-4 mg as required to reach a target blood pressure of less than 150/80 mmHg .
-RESULTS	For total mortality , benefits were consistent : men [ hazard ratio 0.82 , 95 % confidence interval ( CI ) 0.62-1 .11 ] , women ( hazard ratio 0.77 , 95 % CI 0.66-0 .99 ) , those aged 80-84 .9 ( hazard ratio 0.76 , 95 % CI 0.60-0 .96 ) , those aged 85 and over ( hazard ratio 0.87 , 95 % CI 0.64-1 .20 ) , those with a history of CVD ( hazard ratio 0.76 , 95 % CI 0.48-1 .20 ) and those without ( hazard ratio 0.81 , 95 % CI 0.65-0 .99 ) , and similarly across a range of baseline SBPs .
-RESULTS	The point estimates for cardiovascular mortality , strokes , heart failure and cardiovascular events were all in favour of benefit .
-RESULTS	In the per-protocol analysis , strokes were reduced by 34 % ( P = 0.026 ) , total mortality by 28 % ( P = 0.001 ) , cardiovascular event by 37 % ( P < 0.001 ) and heart failure by 72 % ( P < 0.001 ) .
-CONCLUSIONS	In hypertensive patients aged 80 or more , treatment based on indapamide ( sustained-release ) 1.5 mg showed consistent benefits across pre-specified subgroups including those without established CVD ( the majority ) , supporting the need for treatment even at this advanced age .
-CONCLUSIONS	There were too few aged 90 or over to determine benefit from treatment at extreme age .
-
-###24758167
-BACKGROUND	Several studies suggest that most school-age children are poorly informed about cancer risk factors .
-BACKGROUND	This study examines the effectiveness of the ` Be smart against cancer ' ( BSAC ) program in promoting cancer awareness and intentions to engage in health-promoting behavior .
-METHODS	235 seventh-grade students were randomized to either the intervention ( N = 152 ) or the wait-control group ( N = 83 ) .
-METHODS	The intervention included the modules : `` What is cancer ?
-METHODS	, '' `` Sun protection , '' `` Non smoking , '' and `` Physical activity , Healthy nutrition , and Limited alcohol consumption . ''
-METHODS	Outcomes measured at baseline and at the end of the one week BSAC program included knowledge of cancer and its behavioral risk factors , health-promoting intentions , and reported risk behavior .
-RESULTS	BSAC was effective in increasing knowledge about cancer and risk factors for cancer ( p < .001 ) , as well as in increasing intentions to engage in health-promoting behavior ( p < .001 ) , independent of a student 's risk profile .
-RESULTS	Knowledge did not serve as a mediator for intention building .
-CONCLUSIONS	The BSAC is an effective school-based program for raising awareness of cancer , associated risk factors and intentions to engage in cancer-preventive behavior .
-CONCLUSIONS	The results indicate that the effectiveness of BSAC is independent of a student 's risk profile .
-CONCLUSIONS	Therefore , it holds considerable promise as a broadly applicable program to raise cancer awareness and promote healthy behavior intentions .
-
-###24729041
-BACKGROUND	Tuberous sclerosis complex ( TSC ) is characterized by benign tumours in multiple organs , including the brain , kidneys , skin , lungs and heart .
-BACKGROUND	Our objective was to evaluate everolimus , an mTOR inhibitor , in the treatment of angiomyolipoma in patients with subependymal giant cell astrocytoma ( SEGA ) associated with TSC .
-METHODS	EXamining everolimus In a Study of Tuberous Sclerosis Complex-1 ( NCT00789828 ) , a prospective , double-blind , randomized , placebo-controlled , Phase 3 study , examined everolimus in treating SEGA associated with TSC .
-METHODS	Patients with serial SEGA growth from pre-baseline to baseline scans were randomly assigned ( 2:1 ) to receive 4.5 mg/m ( 2 ) / day everolimus ( target blood trough : 5-15 ng/mL ; n = 78 ) or placebo ( n = 39 ) .
-METHODS	Angiomyolipoma response rates were analysed in patients ( n = 44 ) with target baseline angiomyolipoma lesions ( 1 angiomyolipoma ; longest diameter 1.0 cm ) .
-METHODS	An angiomyolipoma response rate , defined as the proportion of patients with confirmed angiomyolipoma response , was assessed by kidney CT or MRI screening at baseline , at 12 , 24 and 48 weeks and annually .
-RESULTS	Angiomyolipoma response rates were 53.3 % ( 16/30 ) and 0 % ( 0/14 ) for everolimus - and placebo-treated patients , respectively .
-RESULTS	Angiomyolipoma reductions 50 % in the sum of volumes of all target lesions were seen only in everolimus-treated patients ( 56.5 , 78.3 and 80.0 % ) compared with placebo-treated patients ( 0 % at each time point ) at Weeks 12 , 24 and 48 , respectively .
-RESULTS	Greater percentages of everolimus-treated patients had angiomyolipoma reductions 30 % at these same time points ( 82.6 , 100 and 100 % versus 8.3 , 18.2 and 16.7 % for everolimus versus placebo , respectively ) .
-CONCLUSIONS	Everolimus showed efficacy in reducing angiomyolipoma lesion volume in patients with SEGA associated with TSC.The trial is registered with ClinicalTrials.gov , number NCT00789828 ; http://clinicaltrials.gov/ct2/show/NCT00789828?term=EXIST-1&rank=1 .
-
-###25028657
-OBJECTIVE	To evaluate the relationship between spectral-domain optical coherence tomography ( OCT ) and standard automated perimetry ( SAP ) in healthy and glaucoma individuals .
-METHODS	The sample comprised 338 individuals divided into 2 groups according to intraocular pressure and visual field outcomes .
-METHODS	All participants underwent a reliable SAP and imaging of the optic nerve head with the Cirrus OCT. .
-METHODS	Pearson correlations were calculated between threshold sensitivity values of SAP ( converted to linear scale ) and OCT parameters .
-RESULTS	Mean age did not differ between the control and glaucoma groups ( 59.55 9.7 years and 61.05 9.4 years , resp. ; P = 0.15 ) .
-RESULTS	Significant differences were found for the threshold sensitivities at each of the 52 points evaluated with SAP ( P < 0.001 ) and the peripapillary retinal nerve fiber layer ( RNFL ) thicknesses , except at 3 and 9 clock-hour positions between both groups .
-RESULTS	Mild to moderate correlations ( ranging between 0.286 and 0.593 ; P < 0.001 ) were observed between SAP and most OCT parameters in the glaucoma group .
-RESULTS	The strongest correlations were found between the inferior RNFL thickness and the superior hemifield points .
-RESULTS	The healthy group showed lower and weaker correlations than the glaucoma group .
-CONCLUSIONS	Peripapillary RNFL thickness measured with Cirrus OCT showed mild to moderate correlations with SAP in glaucoma patients .
-
-###24909799
-OBJECTIVE	Post-menopausal women are at higher risk of cardiovascular disease and bone demineralization .
-OBJECTIVE	Phytosterols ( PS ) may be used for hypercholesterolemia in some groups and - cryptoxanthin ( - Cx ) displays a unique anabolic effect on bone .
-OBJECTIVE	Our aim was to assess the changes in cardiovascular and bone turnover markers from the oral intake of - Cx and PS in post-menopausal women .
-RESULTS	A randomized , double-blind , crossover study with - Cx ( 0.75 mg/day ) and PS ( 1.5 g/day ) , single and combined , was performed in 38 postmenopausal women .
-RESULTS	Diet was supplemented with 1 250 mL milk-based fruit drink/day for 4 weeks with a wash-out period of 4-weeks in between .
-RESULTS	Serum - Cx and PS were determined by UPLC and CG-FID respectively .
-RESULTS	Outcome variables included markers of bone turnover and cardiovascular risk .
-RESULTS	Biological effect was assessed by paired t test and generalized estimating equations analysis that included the previous treatment , the order of intervention and the interactions .
-RESULTS	The intake of beverages containing - Cx and PS brought about a significant increase in serum levels of - Cx , - sitosterol and campesterol .
-RESULTS	Intervention caused changes in almost all the markers while the order , previous treatment and the interaction did not reach statistical significance .
-RESULTS	Only the intake of the beverage containing - Cx plus PS brought about significant decreases in total cholesterol , c-HDL , c-LDL and bone turnover markers .
-CONCLUSIONS	- Cx improves the cholesterol-lowering effect of PS when supplied simultaneously and this combination may also be beneficial in reducing risk of osteoporosis .
-BACKGROUND	ClinicalTrials.gov number NCT01074723 .
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-###25257518
-BACKGROUND	Nonadherence to treatment leads to suboptimal treatment outcomes and enormous costs to the economy .
-BACKGROUND	This is especially important in Parkinson 's disease ( PD ) .
-BACKGROUND	The progressive nature of the degenerative process , the complex treatment regimens and the high rates of comorbid conditions make treatment adherence in PD a challenge .
-BACKGROUND	Clinicians have limited face-to-face consultation time with PD patients , making it difficult to comprehensively address non-adherence .
-BACKGROUND	The rapid growth of digital technologies provides an opportunity to improve adherence and the quality of decision-making during consultation .
-BACKGROUND	The aim of this randomised controlled trial ( RCT ) is to evaluate the impact of using a smartphone and web applications to promote patient self-management as a tool to increase treatment adherence and working with the data collected to enhance the quality of clinical consultation .
-METHODS	A 4-month multicentre RCT with 222 patients will be conducted to compare use of a smartphone - and internet-enabled Parkinson 's tracker smartphone app with treatment as usual for patients with PD and/or their carers .
-METHODS	The study investigators will compare the two groups immediately after intervention .
-METHODS	Seven centres across England ( 6 ) and Scotland ( 1 ) will be involved .
-METHODS	The primary objective of this trial is to assess whether patients with PD who use the app show improved medication adherence compared to those receiving treatment as usual alone .
-METHODS	The secondary objectives are to investigate whether patients who receive the app and those who receive treatment as usual differ in terms of quality of life , quality of clinical consultation , overall disease state and activities of daily living .
-METHODS	We also aim to investigate the experience of those receiving the intervention by conducting qualitative interviews with a sample of participants and clinicians , which will be administered by independent researchers .
-BACKGROUND	ISRCTN45824264 ( registered 5 November 2013 ) .
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-###25035292
-BACKGROUND	The role of adjuvant bisphosphonates in early breast cancer is uncertain .
-BACKGROUND	We therefore did a large randomised trial to investigate the effect of the adjuvant use of zoledronic acid on disease-free survival ( DFS ) in high-risk patients with early breast cancer .
-METHODS	In the AZURE trial , an open-label , international , multicentre , randomised , controlled , parallel-group phase 3 trial , women ( age 18 years ) with stage II or III breast cancer were randomly assigned ( 1:1 ) by a central automated 24-h computer-generated telephone minimisation system ( balanced for number of involved axillary lymph nodes , tumour stage , oestrogen receptor status , type and timing of systemic therapy , menopausal status , statin use , and treatment centre ) to receive standard adjuvant systemic treatment alone ( control group ) or with 4 mg intravenous zoledronic acid every 3-4 weeks for six doses , then every 3 months for eight doses , followed by every 6 months for five doses , for a total of 5 years of treatment .
-METHODS	The primary endpoint was disease-free survival ( DFS ) .
-METHODS	Secondary endpoints were invasive DFS ( IDFS ) , overall survival , time to bone metastases , time to distant recurrence , and subgroup analyses of variables included in the randomisation .
-METHODS	All patients have completed study treatment .
-METHODS	Results from the intention-to-treat final analysis of this fully recruited study are presented after a median follow-up of 84 months ( IQR 66-93 ) .
-METHODS	This final efficacy analysis was planned to take place after 940 DFS events .
-METHODS	This trial is registered with ClinicalTrials.gov , NCT00072020 .
-RESULTS	3360 women were recruited from 174 centres in seven countries between Sept 4 , 2003 , and Feb 16 , 2006 .
-RESULTS	The number of DFS events did not differ between groups : 493 in the control group and 473 in the zoledronic acid group ( adjusted hazard ratio [ HR ] 094 , 95 % CI 082-106 ; p = 030 ) .
-RESULTS	IDFS ( HR 093 , 95 % CI 082-105 ; p = 022 ) , overall survival ( 093 , 081-108 ; p = 037 ) , and distant recurrences ( 093 , 081-107 ; p = 029 ) were much the same in both groups .
-RESULTS	Zoledronic acid reduced the development of bone metastases , both as a first event ( HR 078 , 95 % CI 063-096 ; p = 0020 ) and at any time during follow-up ( 081 , 068-097 ; p = 0022 ) .
-RESULTS	The effects of zoledronic acid on DFS were not affected by oestrogen-receptor status .
-RESULTS	However , zoledronic acid improved IDFS in those who were over 5 years since menopause at trial entry ( n = 1041 ; HR 077 , 95 % CI 063-096 ) but not in all other ( premenopause , perimenopause , and unknown status ) menopausal groups ( n = 2318 ; HR 103 , 95 % CI 089-120 ) .
-RESULTS	33 cases of suspected osteonecrosis of the jaw have been reported , with 26 confirmed on central review , all in the zoledronic acid group ( 17 % , 95 % CI 10-24 ) .
-CONCLUSIONS	These results suggest no overall benefit from the addition of zoledronic acid to standard adjuvant treatments for early breast cancer .
-CONCLUSIONS	However , zoledronic acid does reduce the development of bone metastases and , for women with established menopause , improved disease outcomes .
-BACKGROUND	Novartis Global and NIHR Cancer Research Network .
-
-###24621933
-OBJECTIVE	This study was designed to test the hypothesis of whether amlodipine reduces the risk for death in patients with heart failure due to a nonischemic cardiomyopathy .
-BACKGROUND	A pre-specified subgroup analysis in an earlier , large-scale , placebo-controlled study suggested that amlodipine might reduce the risk for death in patients with heart failure due to a nonischemic cardiomyopathy .
-METHODS	To evaluate this hypothesis , 1654 patients with severe heart failure due to a nonischemic cardiomyopathy ( ejection fraction < 30 % ) were randomly assigned to amlodipine ( target dose : 10 mg/d ) or placebo added to conventional therapy for heart failure for a median of 33 months .
-RESULTS	There were 278 deaths in the amlodipine group and 262 deaths in the placebo group ( hazard ratio : 1.09 ; 95 % confidence interval [ CI ] : 0.92 to 1.29 ; p = 0.33 ) .
-RESULTS	The differences between the 2 groups in the risks for cardiovascular death and hospitalization were also not significant .
-RESULTS	When the results from patients with a nonischemic cardiomyopathy in both the earlier trial and in the current study were combined , there was no evidence of a favorable or unfavorable effect of amlodipine on mortality ( hazard ratio : 0.97 ; 95 % CI : 0.83 to 1.13 ; p = 0.66 ) .
-RESULTS	Both trials , however , observed higher frequencies of peripheral edema and pulmonary edema and lower frequencies of uncontrolled hypertension and chest pain in patients treated with amlodipine .
-CONCLUSIONS	These results of the current trial , viewed together with the results from the earlier study , indicate that amlodipine does not exert favorable effects on the clinical course of patients with heart failure , regardless of the presence or absence of underlying coronary artery disease .
-CONCLUSIONS	These findings indicate the need for great caution when striking benefits are observed in subgroups of patients or in trials not primarily designed to assess such effects .
-
-###24814695
-OBJECTIVE	The aim of our study was to investigate the relationship between nasal irrigation techniques ( NIT ) and the survival rate and the quality of life ( QOL ) in patients with nasal sinusitis ( NS ) .
-METHODS	We studied data from 1134 patients with nasopharyngeal carcinoma ( NPC ) who received radical radiotherapy , which were randomly divided into three groups ( A , B and C ) .
-METHODS	Group A used nasal irrigator ; Group B used homemade nasal irrigation ( NI ) connector combined with enemator ; and Group C used nasal sprayer .
-METHODS	The clinical effects , 5-year overall survival ( OS ) and progression-free survival ( PFS ) were observed .
-METHODS	Furthermore , the QOL in patients with NS was evaluated using the Sino-Nasal Outcome Test 20 .
-RESULTS	The median follow-up time was 69 months .
-RESULTS	The 5-year OS and PFS were 80.5 % and 73.2 % , respectively , for all patients .
-RESULTS	There was no significant difference in OS , PFS , xerostomia and neck skin toxicity grade 3 and greater among groups .
-RESULTS	There was no difference among groups .
-RESULTS	The incidence of NS was the highest in group C.
-CONCLUSIONS	The symptoms of NS seriously affected the QOL period of 1 year .
-CONCLUSIONS	Group C showed no improvement during the follow-up period , which for A and B , by contrast , had after 1 year .
-CONCLUSIONS	Although the exact mechanism remains to be explored in NIT , our findings suggest that patients with NPC should nasal irrigate for 2 years after radiotherapy .
-CONCLUSIONS	Our study shows that a nasal irrigator is necessary for patients with NPC for a high QOL in terms of NS .
-
-###25604688
-OBJECTIVE	To evaluate the safety and efficacy of high-intensity focused ultrasound ( HIFU ) cyclocoagulation in reducing intraocular pressure ( IOP ) in patients with refractory glaucoma by using a novel miniaturized delivery device ( EyeOP1 ) .
-METHODS	We conducted a 12-month open-label multicenter prospective study ( EyeMUST1 Study ) .
-METHODS	Patients with primary ( primary open-angle glaucoma [ POAG ] ) or secondary refractory glaucoma were treated in two groups depending on the duration of each ultrasound shot ( group 1 : 4 seconds ; group 2 : 6 seconds ) .
-METHODS	The primary efficacy outcome was based on IOP reduction at 6 and 12 months .
-RESULTS	Fifty-two patients were enrolled : 36 ( 69 % ) had POAG and 16 ( 31 % ) had secondary glaucoma .
-RESULTS	Group 1 ( n = 24 ) and group 2 ( n = 28 ) had similar demographics and baseline characteristics .
-RESULTS	In group 1 , IOP was reduced from a mean preoperative value of 29.7 7.7 mm Hg ( n = 3.5 glaucoma medications ) to a mean postoperative value of 21.3 6.7 mm Hg ( n = 3.5 glaucoma medications ) and 20.1 6.7 mm Hg ( n = 3.2 glaucoma medications ) at 6 and 12 months , respectively .
-RESULTS	In group 2 , IOP was reduced from a mean preoperative value of 29.0 7.4 mm Hg ( n = 3.3 glaucoma medications ) to a mean postoperative value of 20.2 7.4 mm Hg ( n = 3.4 glaucoma medications ) and 18.5 6.6 mm Hg ( n = 3.5 glaucoma medications ) at 6 and 12 months , respectively .
-RESULTS	At 12 months , the IOP reduction was sustained in both groups ( 32 % IOP reduction in group 1 and 36 % IOP reduction in group 2 ) .
-RESULTS	The overall tolerance of the technique was good , with no serious adverse events .
-CONCLUSIONS	The new miniaturized HIFU EyeOP1 delivery device seems to be effective in decreasing IOP in patients with refractory glaucoma .
-CONCLUSIONS	The technology offers a good safety profile .
-CONCLUSIONS	( ClinicalTrials.gov number , NCT01338467 . )
-
-###25078900
-OBJECTIVE	To compare the efficacy and safety of new insulin glargine 300 units/mL ( Gla-300 ) with glargine 100 units/mL ( Gla-100 ) in people with type 2 diabetes on basal insulin ( 42 units/day ) plus mealtime insulin .
-METHODS	EDITION 1 ( NCT01499082 ) was a 6-month , multinational , open-label , parallel-group study .
-METHODS	Adults with glycated hemoglobin A1c ( HbA1c ) 7.0-10 .0 % ( 53-86 mmol/mol ) were randomized to Gla-300 or Gla-100 once daily with dose titration seeking fasting plasma glucose 4.4-5 .6 mmol/L .
-METHODS	Primary end point was HbA1c change from baseline ; main secondary end point was percentage of participants with one or more confirmed ( 3.9 mmol/L ) or severe nocturnal hypoglycemia from week 9 to month 6 .
-RESULTS	Participants ( n = 807 ) had mean age 60 years , diabetes duration 16 years , BMI 36.6 kg/m ( 2 ) , and HbA1c 8.15 % ( 65.6 mmol/mol ) .
-RESULTS	HbA1c reduction was equivalent between regimens ; least squares mean difference -0.00 % ( 95 % CI -0.11 to 0.11 ) ( -0.00 mmol/mol [ -1.2 to 1.2 ] ) .
-RESULTS	Fewer participants reported one or more confirmed ( 3.9 mmol/L ) or severe nocturnal hypoglycemic events between week 9 and month 6 with Gla-300 ( 36 vs. 46 % with Gla-100 ; relative risk 0.79 [ 95 % CI 0.67-0 .93 ] ; P < 0.005 ) ; nocturnal hypoglycemia incidence and event rates were also lower with Gla-300 in the first 8 weeks of treatment .
-RESULTS	No between-treatment differences in tolerability or safety were identified .
-CONCLUSIONS	Gla-300 controls HbA1c as well as Gla-100 for people with type 2 diabetes treated with basal and mealtime insulin but with consistently less risk of nocturnal hypoglycemia .
-
-###24896137
-OBJECTIVE	To evaluate pazopanib 10 mg/mL eye drops ( pazopanib ) in healthy subjects and in subjects with previously untreated subfoveal choroidal neovascularization secondary to age-related macular degeneration .
-METHODS	Study 1 ( single center , randomized , placebo-controlled , double-masked ) included 3 cohorts of 12 to 13 healthy subjects each who instilled pazopanib or placebo 4 times daily for 2 weeks .
-METHODS	Study 2 ( multicenter open-label ) included 19 subjects with neovascular age-related macular degeneration who instilled pazopanib 4 times daily for 12 weeks .
-METHODS	Both studies evaluated pharmacokinetics and safety .
-METHODS	Study 2 also evaluated efficacy .
-RESULTS	Steady-state concentrations of pazopanib in plasma seemed to be reached by Week 2 .
-RESULTS	At Week 4 ( Study 2 ) , there were no meaningful changes from baseline in the mean central retinal thickness ( 37.9 m ) or best-corrected visual acuity ( 0.1 letters ) ( primary endpoint ) , retinal morphology , choroidal neovascularization size , or total lesion size .
-RESULTS	Complement Factor H genotype had no effect on changes from baseline in the best-corrected visual acuity or central retinal thickness .
-RESULTS	The most common pazopanib-related ocular adverse events included eye irritation ( Study 1 , n = 7 ) and instillation site pain ( Study 2 , n = 3 ) .
-RESULTS	No serious adverse events were reported .
-CONCLUSIONS	Pazopanib was well tolerated .
-CONCLUSIONS	In subjects with previously untreated neovascular age-related macular degeneration , pazopanib instilled 4 times daily as monothereapy did not seem to improve the best-corrected visual acuity or decrease the central retinal thickness .
-
-###24714795
-BACKGROUND	Characterized as a sudden and temporary loss of consciousness and postural tone , with quick and spontaneous recovery , syncope is caused by an acute reduction of systemic arterial pressure and , therefore , of cerebral blood flow .
-BACKGROUND	Unsatisfactory results with the use of drugs allowed the nonpharmacological treatment of neurocardiogenic syncope was contemplated as the first therapeutic option .
-OBJECTIVE	To compare , in patients with neurocardiogenic syncope , the impact of a moderate intensity aerobic physical training ( AFT ) and a control intervention on the positivity of head-up tilting test ( HUT ) and orthostatic tolerance time .
-METHODS	Were studied 21 patients with a history of recurrent neurocardiogenic syncope and HUT .
-METHODS	The patients were randomized into : trained group ( TG ) , n = 11 , and control group ( CG ) , n = 10 .
-METHODS	The TG was submitted to 12 weeks of AFT supervised , in cycle ergometer , and the CG to a control procedure that consisted in 15 minutes of stretching and 15 minutes of light walk .
-RESULTS	The TG had a positive effect to physical training , with a significant increase in peak oxygen consumption .
-RESULTS	The CG did not show any statistically significant change before and after the intervention .
-RESULTS	After the intervention period , 72.7 % of the TG sample had negative results to the HUT , not having syncope in the revaluation .
-CONCLUSIONS	The program of supervised aerobic physical training for 12 weeks was able to reduce the number of positive HUT , as it was able to increase tolerance time in orthostatic position during the HUT after the intervention period .
-
-###25934242
-BACKGROUND	Lumboperitoneal shunt surgery has the potential to alleviate symptoms of normal pressure hydrocephalus but the benefits of such surgery have not been tested in a randomised trial .
-BACKGROUND	The aim of this trial was to determine the safety and efficacy of the lumboperitoneal shunt surgery for this disorder .
-METHODS	For the open-label randomised SINPHONI-2 trial , eligible participants ( 60-85 years of age ) with idiopathic normal pressure hydrocephalus , with ventriculomegaly , and tightness of the high-convexity and medial subarachnoid spaces on MRI , were recruited from 20 neurological and neurosurgical centres in Japan .
-METHODS	Enrolled participants were randomly assigned in a 1:1 ratio according to a random code generated by the trial statistician , with a permuted block design ( using a block size of 4 or 6 ) within each centre , to receive lumboperitoneal shunt surgery within 1 month after randomisation , or to surgery postponed for 3 months .
-METHODS	Patients and assessors were not masked to treatment assignment .
-METHODS	The primary endpoint was favourable outcome , defined as an improvement of one point or more on the modified Rankin scale ( mRS ) at 3 months after randomisation , analysed by intention to treat , and the main secondary endpoint was the same outcome 12 months after surgery , analysed per protocol .
-METHODS	This trial is registered with the University Hospital Medical Information Network Clinical Trials Registry ( UMIN-CTR ) , number UMIN000002730 .
-RESULTS	Between March 1 , 2010 , and Oct 19 , 2011 , 93 patients with idiopathic normal pressure hydrocephalus were enrolled and randomly assigned to the immediate treatment group ( n = 49 ) or the postponed treatment group ( n = 44 ) .
-RESULTS	More patients in the immediate treatment group than in the postponed treatment group had an improvement of one point or more on the mRS at 3 months : 32 ( 65 % ) of 49 in the immediate group vs 2 ( 5 % ) of 44 in the postponed group ( difference 61 % [ 95 % CI 42-68 ] ; p < 00001 ) .
-RESULTS	The number of patients who had an improvement of one point or more on the mRS at 12 months after surgery was similar between the two groups : 30 ( 67 % ) of 45 patients in the immediate group vs 22 ( 58 % ) of 38 in the postponed group ( difference 9 % [ 95 % CI -14 to 31 ] ; p = 0496 ) .
-RESULTS	The proportions of patients with serious adverse events did not differ significantly between the groups during the 3 months post-randomisation ( 7 [ 15 % ] of 46 in the immediate group vs 1 [ 2 % ] of 42 in the postponed group ; p = 0060 ) .
-RESULTS	During the 12 months after surgery , 19 ( 22 % ) of 87 patients had serious adverse events , the most common of which was cerebral infarction ( six patients [ 7 % ] ) .
-CONCLUSIONS	Our results suggest that lumboperitoneal shunt surgery might be beneficial for patients with idiopathic normal pressure hydrocephalus and , if these findings are confirmed in larger studies , could be a first-line treatment option for this disease .
-BACKGROUND	Johnson & Johnson and Nihon Medi-Physics .
-
-###24817517
-BACKGROUND	Breast magnetic resonance imaging ( MRI ) has shown high sensitivity in determining tumor extent , multifocality , and occult contralateral breast cancer .
-BACKGROUND	Low specificity , unnecessary mastectomies , and costs are arguments against MRI .
-BACKGROUND	The purpose of this study was to determine whether preoperative breast MRI would affect primary surgical management , reduce reexcision/reoperation procedures , and influence the choice of neoadjuvant treatment in patients with newly diagnosed breast cancer .
-METHODS	This prospective , randomized , multicenter study included 440 breast cancer patients younger than aged 56 years from three , Swedish , large-volume breast units .
-METHODS	Patients were randomly allocated on a 1:1 basis to either preoperative staging with breast MRI ( n = 220 ) or no breast MRI ( n = 220 ) ( control group ) .
-METHODS	Treatment planning of all patients was discussed at multidisciplinary team conferences .
-RESULTS	In patients randomized to the MRI group , who had an observed higher percentage of planned breast-conserving surgery ( BCS ) compared with the control group , a change from suggested breast conservation to mastectomy occurred in 23 of 153 ( 15 % ) patients .
-RESULTS	Breast MRI provided additional information in 83 of 220 ( 38 % ) patients , which caused a change in treatment plan in 40 ( 18 % ) .
-RESULTS	The breast reoperation rate was significantly lower in the MRI group : 11 of 220 ( 5 % ) versus 33 of 220 ( 15 % ) in the control group ( p < 0.001 ) .
-RESULTS	The number of mastectomies , axillary reoperations , and the number of patients receiving neoadjuvant chemotherapy after definitive treatment did not differ significantly between the groups .
-CONCLUSIONS	Preoperative staging with breast MRI in women younger than age 56 years altered the treatment plan in 18 % of the patients .
-CONCLUSIONS	Although a higher MRI-related conversion rate from breast conservation to mastectomy was found , the final numbers of mastectomies did not differ between the two groups .
-CONCLUSIONS	The breast reoperation rate in the MRI group was significantly reduced .
-
-###24964217
-OBJECTIVE	Pain at the surgery site is a common complaint in patients who experience percutaneous nephrolithotomy ( PCNL ) .
-OBJECTIVE	The aim of this double-blind , randomized clinical trial is evaluation of the effect of scheduled infusion of bupivacaine on postsurgical pain and narcotic consumption after tubeless PCNL under spinal anesthesia .
-METHODS	Forty patients were randomly divided into two groups .
-METHODS	A small caliber fenestrated feeding tube was placed into the nephrostomy tract under direct vision in a manner in which its tip lied close to the renal capsule .
-METHODS	The study group received infusion of diluted bupivacaine while physiologic saline was injected in the control group .
-METHODS	Each patient was given the same dose every 6 hours until 24 hours after the surgical procedure .
-RESULTS	Mean pethidine injection was significantly lower in the group who underwent bupivacaine instillation ( 20.514.5 vs 3.972.4 mg : P = 0.009 ) .
-RESULTS	There was no significant difference between mean visual analogue scale ( VAS ) score in these two groups after 6 and 12 hours while it was significantly lower after 18 and 24 hours in the patients who had received bupivacaine .
-RESULTS	Mean time to the first analgesic request was significantly longer in the study group ( 11.35 vs 6.44 hours : P = 0.001 ) .
-CONCLUSIONS	Intermittent perirenal instillation of bupivacaine via the nephrostomy tract after PCNL decreases the need for more systemic narcotics and provides acceptable analgesia in the postoperative period .
-
-###24811615
-BACKGROUND	Inflammation plays a major role in diabetes-associated cardiovascular disease ( CVD ) .
-BACKGROUND	There is uncertainty whether diet and physical activity interventions can be successfully integrated into healthcare settings and reduce markers of inflammation and risk of CVD in patients with type 2 diabetes ( T2D ) .
-RESULTS	Systemic markers of inflammation were determined in a 12-month , real-world , multicenter , randomized , controlled trial that investigated the effect of diet , diet plus physical activity , and usual care in 593 individuals with newly diagnosed T2D .
-RESULTS	During the first 6 months , serum C-reactive protein ( CRP ) improved by -21 ( -36 to -1.4 ) % and -22 ( -38 to -3.1 ) % in diet and diet plus physical activity arms versus usual care .
-RESULTS	There were also improvements in adiponectin and soluble intercellular adhesion molecule-1 ( sICAM-1 ) .
-RESULTS	Though medication-adjusted CRP was improved between 6 and 12 months for usual care , both interventions were more successful in reducing the relative risk of a high-risk CRP level of > 3 mg/L ( risk ratios of 0.72 [ 0.55 to 0.95 ] for diet versus usual care and 0.67 [ 0.50 to 0.90 ] for diet plus activity versus usual care ) .
-RESULTS	Furthermore , sICAM-1 ( a marker of vascular risk ) , remained substantially lower than usual care in both intervention arms at 12 months .
-CONCLUSIONS	Motivational , unsupervised diet and/or diet plus physical activity interventions given soon after diagnosis in real-world healthcare settings improve markers of inflammation and cardiovascular risk in patients with T2D , even after accounting for the effect of adjustments to medication to try and control blood pressure , glycated hemoglobin , and lipids .
-BACKGROUND	http://www.controlled-trials.com/ .
-BACKGROUND	Unique identifier : ISRCTN92162869 .
-
-###25554994
-BACKGROUND	This study seeks to provide a comprehensive and systematic evaluation of baseline clinical and psychological features and treatment response characteristics that differentiate Major Depressive Disorder ( MDD ) outpatients with and without melancholic features .
-BACKGROUND	Reflecting the emphasis in DSM-5 , we also include impairment and distress .
-METHODS	Participants were assessed pre-treatment on clinical features ( severity , risk factors , comorbid conditions , illness course ) , psychological profile ( personality , emotion regulation ) , functional capacity ( social and occupational function , quality of life ) and distress/coping ( negativity bias , emotional resilience , social skills , satisfaction with life ) .
-METHODS	Participants were randomized to sertraline , escitalopram or venlafaxine extended-release and re-assessed post-treatment at 8 weeks regarding remission , response , and change in impairment and distress .
-RESULTS	Patients with melancholic features ( n = 339 ; 33.7 % ) were distinguished clinically from non-melancholics by more severe depressive symptoms and greater exposure to abuse in childhood .
-RESULTS	Psychologically , melancholic patients were defined by introversion , and a greater use of suppression to regulate negative emotion .
-RESULTS	Melancholics also had poorer capacity for social and occupational function , and physical and psychological quality of life , along with poorer coping , reflected in less emotional resilience and capacity for social skills .
-RESULTS	Post-treatment , melancholic patients had lower remission and response , but some of this effect was due to the more severe symptoms pre-treatment .
-RESULTS	The distress/coping outcome measure of capacity for social skills remained significantly lower for melancholic participants .
-CONCLUSIONS	Due to the cross-sectional nature of this study , causal pathways can not be concluded .
-CONCLUSIONS	Findings provide new insights into a melancholic profile of reduced ability to function interpersonally or effectively deal with ones emotions .
-CONCLUSIONS	This distinctly poorer capacity for social skills remained post-treatment .
-CONCLUSIONS	The pre-treatment profile may account for some of the difficulty in achieving remission or response with treatment .
-
-###24884422
-BACKGROUND	The efficacy of topical ophthalmic corticosteroids depends upon small modifications in preparations , such as drug concentration.The aim of this study was to confirm that hydrocortisone acetate ( HC-ac ) ophthalmic ointments of 2.5 % and 1 % are more effective than a 0.5 % eye ointment .
-METHODS	In this randomized , double-blind , placebo-controlled , parallel-group clinical study , the change of signs and symptoms of acute inflammation of the ocular surface and adnexa was evaluated in 411 subjects .
-RESULTS	Median time to clinically relevant response as estimated by 50 % reduction in clinical signs and symptoms ( CSS ) total score over the entire trial was similar for subjects treated with HC-ac 2.5 % ( 73.5 h ) and for subjects treated with HC-ac 1.0 % ( 67.7 h ) and was considerably and significantly longer for subjects treated with HC-ac 0.5 % ( 111.8 h ) [ p < 0.001 for both dosages ] .
-RESULTS	All trial medications were safe and well tolerated .
-CONCLUSIONS	Hydrocortisone acetate 2.5 % and Hydrocortisone acetate 1 % eye ointments are efficacious and safe treatments for acute inflammations of the ocular surface or adnexa , and showed significantly better efficacy than a control group treated with Hydrocortisone acetate 0.5 % therapy .
-BACKGROUND	Current Controlled Trials ISRCTN15464650 .
-
-###24812043
-BACKGROUND	Patients with multiple sclerosis ( MS ) lose brain volume ( BV ) faster than healthy individuals .
-OBJECTIVE	Our purpose , within the 12-month phase 3 TRANSFORMS study , was to examine the effect of treatment on BV loss in patient subgroups , establish correlations between baseline normalized BV ( NBV ) and baseline disease parameters , to identify variables predictive of baseline NBV and on-study percentage BV change ( PBVC ) , and to establish correlations between on-study PBVC and on-study efficacy outcomes .
-METHODS	Patients received fingolimod 0.5 mg or 1.25 mg , or intramuscular ( IM ) interferon -1 a ( IFN-1a ) for 12 months .
-METHODS	The effect of treatment on PBVC was examined in patient demographic , disease and magnetic resonance imaging ( MRI ) characteristic subgroups .
-METHODS	Pearson 's correlation analyses and a stepwise linear regression model were used to identify variables predictive of NBV and PBVC .
-RESULTS	Fingolimod reduced BV loss over 12 months versus IFN-1a IM in all patient subgroups assessed , including individuals with or without gadolinium ( Gd ) - enhancing lesions at baseline .
-RESULTS	Baseline T1 hypointense lesion volume had the strongest correlation with baseline NBV .
-RESULTS	Baseline Gd-enhancing T1 lesion count was most predictive of change in PBVC over 12 months .
-CONCLUSIONS	Our results improve understanding of the contributions of different baseline demographic , clinical and MRI characteristics to NBV , including factors that may be predictive of future BV loss .
-
-###25164908
-BACKGROUND	In a Spanish Lung Cancer Group ( SLCG ) phase II trial , the combination of BRCA1 and receptor-associated protein 80 ( RAP80 ) expression was significantly associated with outcome in Caucasian patients with nonsmall-cell lung cancer ( NSCLC ) .
-BACKGROUND	The SLCG therefore undertook an industry-independent collaborative randomized phase III trial comparing nonselected cisplatin-based chemotherapy with therapy customized according to BRCA1/RAP80 expression .
-BACKGROUND	An analogous randomized phase II trial was carried out in China under the auspices of the SLCG to evaluate the effect of BRCA1/RAP80 expression in Asian patients .
-METHODS	Eligibility criteria included stage IIIB-IV NSCLC and sufficient tumor specimen for molecular analysis .
-METHODS	Randomization to the control or experimental arm was 1 : 1 in the SLCG trial and 1 : 3 in the Chinese trial .
-METHODS	In both trials , patients in the control arm received docetaxel/cisplatin ; in the experimental arm , patients with low RAP80 expression received gemcitabine/cisplatin , those with intermediate/high RAP80 expression and low/intermediate BRCA1 expression received docetaxel/cisplatin , and those with intermediate/high RAP80 expression and high BRCA1 expression received docetaxel alone .
-METHODS	The primary end point was progression-free survival ( PFS ) .
-RESULTS	Two hundred and seventy-nine patients in the SLCG trial and 124 in the Chinese trial were assessable for PFS .
-RESULTS	PFS in the control and experimental arms in the SLCG trial was 5.49 and 4.38 months , respectively [ log rank P = 0.07 ; hazard ratio ( HR ) 1.28 ; P = 0.03 ] .
-RESULTS	In the Chinese trial , PFS was 4.74 and 3.78 months , respectively ( log rank P = 0.82 ; HR 0.95 ; P = 0.82 ) .
-CONCLUSIONS	Accrual was prematurely closed on the SLCG trial due to the absence of clinical benefit in the experimental over the control arm .
-CONCLUSIONS	However , the BREC studies provide proof of concept that an international , nonindustry , biomarker-directed trial is feasible .
-CONCLUSIONS	Thanks to the groundwork laid by these studies , we expect that ongoing further research on alternative biomarkers to elucidate DNA repair mechanisms will help define novel therapeutic approaches .
-BACKGROUND	NCT00617656/GECP-BREC and ChiCTR-TRC-12001860 / BREC-CHINA .
-
-###25419804
-OBJECTIVE	To determine pharmacokinetics of marbofloxacin in water buffalo calves ( Bubalus bubalis ) after multiple SC administrations and to assess differences in regimen efficacy .
-METHODS	18 healthy buffalo calves .
-METHODS	Calves ( n = 6 calves/group ) were assigned to receive marbofloxacin SC in the neck at 1 of 3 dosages ( 2 mg/kg , q 24 h for 6 days [ regimen 1 ] ; 4 mg/kg , q 48 h for 6 days [ regimen 2 ] ; and 4 mg/kg , q 24 h for 3 days [ regimen 3 ] ) .
-METHODS	Serum marbofloxacin concentrations were analyzed .
-METHODS	Efficacy predictors were estimated on the basis of minimum inhibitory concentration and mutant prevention concentration reported for Pasteurella multocida and Mannheimia haemolytica .
-RESULTS	Mean SD area under the concentration-time curve was 5.92 0.40 gh/mL for regimen 1 , which differed significantly from that for regimens 2 ( 14.26 0.92 gh/mL ) and 3 ( 14.17 0.51 gh/mL ) .
-RESULTS	Mean residence time and mean elimination half-life for regimen 2 ( 9.93 0.20 hours and 8.77 0.71 hours ) both differed significantly from those for regimens 1 ( 721 0.11 hours and 5.71 0.38 hours ) and 3 ( 759 0.13 hours and 737 1.19 hours ) .
-RESULTS	Values obtained from indices for P multocida and M haemolytica had an excessively wide range because of the various degrees of antimicrobial susceptibility ( low , medium , and high ) of the strains .
-CONCLUSIONS	Regimen 3 had the most favorable indices , and it would be conducive for owner compliance and require less handling of animals .
-
-###25847934
-OBJECTIVE	Cixutumumab , formerly IMC-A12 , is a recombinant human monoclonal immunoglobulin G1 antibody that targets insulin-like growth factor I receptor ( IGF-IR ) .
-OBJECTIVE	Cixutumumab was synergistic with castration in a hormone-sensitive prostate cancer xenograft model .
-METHODS	Patients with new metastatic prostate cancer were randomly assigned within 30 days of initiating androgen deprivation ( AD ) to cixutumumab added to a luteinizing hormone-releasing hormone agonist with bicalutamide versus AD alone .
-METHODS	With 180 patients and one-sided alpha of 0.10 , there would be 90 % power to detect an absolute 20 % difference in undetectable prostate-specific antigen ( PSA ; 0.2 ng/mL ) rate at 28 weeks ( relative risk , 1.44 ) ; this end point was previously strongly correlated with survival .
-METHODS	Secondary end points included the proportion of patients with PSA > 4.0 ng/mL , safety and tolerability , circulating tumor cell ( CTC ) levels , and seven plasma IGF-IR biomarkers .
-METHODS	Fisher 's exact test was used for the primary end point , and extended Mantel-Haenszel ( 2 ) test was used for three PSA response categories .
-RESULTS	The trial accrued 210 eligible patients ( 105 randomly assigned to each arm ) .
-RESULTS	Patient characteristics were similar in both arms .
-RESULTS	Undetectable PSA rate was 42 ( 40.0 % ) of 105 for cixutumumab plus AD and 34 ( 32.3 % ) of 105 for AD alone ( relative risk , 1.24 ; one-sided P = .16 ) .
-RESULTS	Lower baseline CTCs ( 0 v 1 to 4 v 5/7 .5 mL whole blood ) were associated with higher rate of PSA response ( three categories ; P = .036 ) in 39 evaluable patients .
-RESULTS	IGF-IR biomarkers were not correlated with PSA outcome , and cixutumumab did not significantly change these biomarker levels .
-CONCLUSIONS	Cixutumumab plus AD did not significantly increase the undetectable PSA rate in men with new metastatic hormone-sensitive prostate cancer .
-CONCLUSIONS	CTCs at baseline may carry prognostic value .
-
-###24323565
-BACKGROUND	The risk for malignant melanoma is higher than expected in Parkinson 's disease ( PD ) .
-BACKGROUND	The National Institutes of Health ( NIH ) Exploratory Trials in PD ( NET-PD ) Long-term Study 1 ( LS-1 ) trial is a contemporary phase 3 study of subjects with early , treated PD .
-BACKGROUND	The objective of this work was to assess the incidence of malignant melanoma in a PD cohort .
-METHODS	Incident melanoma cases were identified from the adverse events log .
-METHODS	The expected number of cases was calculated , using the expected incidence rates and the number of person-years .
-RESULTS	A total of 618 females and 1119 males were followed for 6452 person-years ; 19 new melanoma cases were observed .
-RESULTS	The expected number was 5.29 .
-RESULTS	The standardized event ratio compared to the general population was 3.6 ( 95 % confidence interval , 2.2-5 .6 ) .
-CONCLUSIONS	The risk for developing melanoma was higher than expected in the NET-PD LS-1 cohort and was similar to the risk reported in earlier comparable clinical trial cohorts .
-CONCLUSIONS	Dermatologic screening may be useful in Parkinson 's disease to identify melanoma at an early stage .
-
-###24274589
-BACKGROUND	Infected necrotising pancreatitis is a potentially lethal disease that nearly always requires intervention .
-BACKGROUND	Traditionally , primary open necrosectomy has been the treatment of choice .
-BACKGROUND	In recent years , the surgical step-up approach , consisting of percutaneous catheter drainage followed , if necessary , by ( minimally invasive ) surgical necrosectomy has become the standard of care .
-BACKGROUND	A promising minimally invasive alternative is the endoscopic transluminal step-up approach .
-BACKGROUND	This approach consists of endoscopic transluminal drainage followed , if necessary , by endoscopic transluminal necrosectomy .
-BACKGROUND	We hypothesise that the less invasive endoscopic step-up approach is superior to the surgical step-up approach in terms of clinical and economic outcomes .
-METHODS	The TENSION trial is a randomised controlled , parallel-group superiority multicenter trial .
-METHODS	Patients with ( suspected ) infected necrotising pancreatitis with an indication for intervention and in whom both treatment modalities are deemed possible , will be randomised to either an endoscopic transluminal or a surgical step-up approach .
-METHODS	During a 4year study period , 98 patients will be enrolled from 24 hospitals of the Dutch Pancreatitis Study Group .
-METHODS	The primary endpoint is a composite of death and major complications within 6months following randomisation .
-METHODS	Secondary endpoints include complications such as pancreaticocutaneous fistula , exocrine or endocrine pancreatic insufficiency , need for additional radiological , endoscopic or surgical intervention , the need for necrosectomy after drainage , the number of ( re - ) interventions , quality of life , and total direct and indirect costs .
-CONCLUSIONS	The TENSION trial will answer the question whether an endoscopic step-up approach reduces the combined primary endpoint of death and major complications , as well as hospital stay and related costs compared with a surgical step-up approach in patients with infected necrotising pancreatitis .
-
-###25277638
-OBJECTIVE	In this double-blind , randomized study , the authors compared the effects of a patient-controlled remifentanil and morphine combination with morphine alone on post-thoracotomy pain , analgesic consumption , and side effects .
-METHODS	A prospective , randomized , double-blind clinical study .
-METHODS	University hospital .
-METHODS	Volunteer patients at a university hospital undergoing elective thoracotomy surgery .
-METHODS	Patients were allocated randomly into 2 groups to receive patient-controlled analgesia : the morphine ( M ) group or the morphine plus remifentanil ( MR ) group .
-METHODS	Pain , discomfort , sedation scores , cumulative patient-controlled morphine consumption , rescue analgesic ( meperidine ) requirement and side effects were recorded for 24 hours .
-RESULTS	Sixty patients were allocated randomly to receive intravenous patient-controlled analgesia with morphine alone ( M ) or morphine plus remifentanil ( MR ) in a double-blind manner .
-RESULTS	Patients were allowed to use bolus doses of morphine ( 0.02 mg/kg ) or the same dose of a morphine plus remifentanil ( 0.2 g/kg ) mixture every 10 minutes without a background infusion .
-RESULTS	VAS scores were lower in the MR group than in the M group at 30 minutes ( p = 0.04 ) , 1 hour ( p = 0.03 ) , and 2 hours ( p = 0.04 ) .
-RESULTS	Mean cumulative doses of morphine were not significantly different at 27.815 mg for the M group and 21.910.5 mg for the MR group .
-RESULTS	Significantly more patients needed meperidine in the M group ( p = 0.039 ) ; these also experienced more nausea ( p = 0.01 ) .
-CONCLUSIONS	Coadministration of PCA remifentanil with morphine for the treatment of post-thoracotomy pain did not reduce morphine consumption but provided superior analgesia , less use of rescue analgesics , and fewer side effects compared to morphine alone .
-
-###24624390
-OBJECTIVE	To evaluate the effect of different maintenance recall intervals in patients with chronic periodontitis treated by full-mouth ultrasonic debridement .
-METHODS	Twenty-eight patients participated in the study and were divided into two groups : group 1 ( n = 14 ) underwent full-mouth ultrasonic debridement followed by monthly supportive periodontal therapy ; group 2 ( n = 14 ) underwent full-mouth ultrasonic debridement followed by supportive periodontal therapy delivered at 3-month intervals .
-METHODS	Plaque index ( PI ) , bleeding on probing ( BOP ) , pocket probing depth ( PD ) , gingival recession ( GR ) and clinical attachment level ( CAL ) were evaluated at baseline and after 3 and 6 months .
-RESULTS	Subjects in group 1 had statistically significantly lower PI scores than did subjects in group 2 at six months .
-RESULTS	However , no differences in BOP , PPD , GR and CAL were observed between groups at any of the time points evaluated .
-RESULTS	Nonetheless , while full-mouth BOP and PPD scores progressively decreased over time in group 1 , the same parameters were significantly reduced at 3 months in group 2 , but remained stable thereafter .
-RESULTS	The proportion of moderate and deep pockets decreased progressively over time in the group of monthly recalls , while the proportion of moderate to deep sites decreased significantly in group 2 only at 3 months ; no additional reductions were seen at 6 months .
-CONCLUSIONS	Supportive periodontal therapy both at one - and three-month intervals promotes short-term stability of clinical improvements obtained after full-mouth ultrasonic debridement in patients with chronic periodontitis .
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-###25282345
-BACKGROUND	It is well documented that heightened levels of parenting stress have a negative influence on children 's socio-emotional and behavioral development .
-BACKGROUND	Parenting stress may therefore be regarded as an outcome variable in its own right .
-BACKGROUND	This study investigated whether a sensitizing intervention influences stress reported by parents of prematurely born children until the children were age nine .
-METHODS	Preterm infants ( N = 146 , birth weight < 2,000 g ) were randomized to intervention ( N = 72 ) with the Mother-Infant Transaction Program ( MITP ) or a preterm control group ( N = 74 ) that received standard hospital care .
-METHODS	A term reference group comprised 75 healthy , full-term neonates .
-METHODS	Parents reported on the Parenting Stress Index ( PSI ) when the children were 6 months , 1 , 2 , 3 , 5 , 7 years old and on the PSI-Short Form ( PSI-SF ) at age 9 .
-METHODS	Main outcomes were the mother 's and father 's reports of total , child and parent-related stress .
-METHODS	Cross-sectional and longitudinal analyses were performed using linear mixed models ( LMM ) , taking dependency in the data caused by twin pairs and repeated measures into account .
-METHODS	Response rates were high across all follow-ups , and still reached 85 % from mothers and 72 % from fathers at 9 years .
-RESULTS	Mothers in the intervention group reported better longitudinal development of child-related stress than mothers of preterm controls , as they perceived their children as being more adaptable and less moody throughout childhood until the age of seven .
-RESULTS	Less stress in the intervention group was revealed by cross-sectional analysis of maternal reports at all ages , while fathers reported similar differences at ages three and five .
-RESULTS	Parents in the intervention group reported stronger agreement on several stress scores on several occasions .
-RESULTS	Fathers with high interventional participation ( mean 54 % ) reported significantly less stress at age nine than those who participated less .
-RESULTS	Both parents in the intervention group reported levels of stress similar to those experienced by the term reference group at all follow-ups , while differences between the preterm control and term reference groups increased .
-CONCLUSIONS	This early intervention reduces stress among parents of prematurely born children to a level reported by parents of term-born children and enhances agreement between parents .
-BACKGROUND	Clinical Trials Gov identifier NCT00222456 , 05.09.2005 .
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-###24525316
-BACKGROUND	Present combination antiretroviral therapy ( cART ) alone does not cure HIV infection and requires lifelong drug treatment .
-BACKGROUND	The potential role of HIV therapeutic vaccines as part of an HIV cure is under consideration .
-BACKGROUND	Our aim was to assess the efficacy , safety , and immunogenicity of Vacc-4x , a peptide-based HIV-1 therapeutic vaccine targeting conserved domains on p24 ( Gag ) , in adults infected with HIV-1 .
-METHODS	Between July , 2008 , and June , 2010 , we did a multinational double-blind , randomised , phase 2 study comparing Vacc-4x with placebo .
-METHODS	Participants were adults infected with HIV-1 who were aged 18-55 years and virologically suppressed on cART ( viral load < 50 copies per mL ) with CD4 cell counts of 400 10 ( 6 ) cells per L or greater .
-METHODS	The trial was done at 18 sites in Germany , Italy , Spain , the UK , and the USA .
-METHODS	Participants were randomly assigned ( 2:1 ) to Vacc-4x or placebo .
-METHODS	Group allocation was masked from participants and investigators .
-METHODS	Four primary immunisations , weekly for 4 weeks , containing Vacc-4x ( or placebo ) were given intradermally after administration of adjuvant .
-METHODS	Booster immunisations were given at weeks 16 and 18 .
-METHODS	At week 28 , cART was interrupted for up to 24 weeks .
-METHODS	The coprimary endpoints were cART resumption and changes in CD4 counts during treatment interruption .
-METHODS	Analyses were by modified intention to treat : all participants who received one intervention .
-METHODS	Furthermore , safety , viral load , and immunogenicity ( as measured by ELISPOT and proliferation assays ) were assessed .
-METHODS	The 52 week follow-up period was completed in June , 2011 .
-METHODS	For the coprimary endpoints the proportion of participants who met the criteria for cART resumption was analysed with a logistic regression model with the treatment effect being assessed in a model including country as a covariate .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT00659789 .
-RESULTS	174 individuals were screened ; because of slow recruitment , enrolment stopped with 136 of a planned 345 participants and 93 were randomly assigned to receive Vacc-4x and 43 to receive placebo .
-RESULTS	There were no differences between the two groups for the primary efficacy endpoints in those participants who stopped cART at week 28 .
-RESULTS	Of the participants who resumed cART , 30 ( 34 % ) were in the Vacc-4x group and 11 ( 29 % ) in the placebo group , and percentage changes in CD4 counts were not significant ( mean treatment difference -571 , 95 % CI -1301 to 159 ) .
-RESULTS	However , a significant difference in viral load was noted for the Vacc-4x group both at week 48 ( median 23,100 copies per mL Vacc-4x vs 71,800 copies per mL placebo ; p = 0025 ) and week 52 ( median 19,550 copies per mL vs 51,000 copies per mL ; p = 0041 ) .
-RESULTS	One serious adverse event , exacerbation of multiple sclerosis , was reported as possibly related to study treatment .
-RESULTS	Vacc-4x was immunogenic , inducing proliferative responses in both CD4 and CD8 T-cell populations .
-CONCLUSIONS	The proportion of participants resuming cART before end of study and change in CD4 counts during the treatment interruption showed no benefit of vaccination .
-CONCLUSIONS	Vacc-4x was safe , well tolerated , immunogenic , seemed to contribute to a viral-load setpoint reduction after cART interruption , and might be worth consideration in future HIV-cure investigative strategies .
-BACKGROUND	Norwegian Research Council GLOBVAC Program and Bionor Pharma ASA .
-
-###25148169
-OBJECTIVE	The goal of this study was to analyze the differences in ultrasound characteristics of papillary thyroid carcinoma ( PTC ) originating in the thyroid isthmus versus that originating from the lobes .
-METHODS	From a retrospective review of our institution 's database of records dated between January 2007 and December 2008 , we identified 48 patients with classic PTCs located in the isthmus .
-METHODS	All the patients had undergone preoperative ultrasound imaging , total thyroidectomy with bilateral central lymph node dissection , and postoperative follow-up for at least 2 years .
-METHODS	As a control group , 96 patients with classic PTCs located in the lobe who had undergone total thyroidectomy with bilateral central lymph node dissection during the same period were randomly matched to the study patients for age , sex , and tumor size .
-RESULTS	According to the clinicopathologic analyses , the incidence of extrathyroidal extension was higher in the patients with a tumor originating in the isthmus than in the control group ( p = 0.026 ) .
-RESULTS	According to the imaging analyses , the tumors originating in the isthmus more frequently had a circumscribed margin ( p = 0.030 ) , a wider-than-tall shape ( p < 0.001 ) , and the suspicion of extrathyroidal extension ( p < 0.001 ) than those originating from the lobes .
-CONCLUSIONS	The results of this study showed that PTCs originating in the isthmus were more likely to have extrathyroidal extension than those originating from the lobes .
-CONCLUSIONS	Therefore , careful ultrasound evaluation should be performed on masses in the thyroid isthmus even if ultrasound shows a circumscribed mass with a wider-than-tall shape .
-
-###25542311
-OBJECTIVE	The study was designed to determine whether response-based therapy improves outcomes in intermediate-risk Hodgkin lymphoma .
-OBJECTIVE	We examined patterns of first relapse in the study .
-METHODS	From September 2002 to July 2010 , 1712 patients < 22 years old with stage I-IIA with bulk , I-IIAE , I-IIB , and IIIA-IVA with or without doxorubicin , bleomycin , vincristine , etoposide , prednisone , and cyclophosphamide were enrolled .
-METHODS	Patients were categorized as rapid ( RER ) or slow early responders ( SER ) after 2 cycles of doxorubicin , bleomycin , vincristine , etoposide , prednisone , and cyclophosphamide ( ABVE-PC ) .
-METHODS	The SER patients were randomized to 2 additional ABVE-PC cycles or augmented chemotherapy with 21 Gy involved field radiation therapy ( IFRT ) .
-METHODS	RER patients were stipulated to undergo 2 additional ABVE-PC cycles and were then randomized to 21 Gy IFRT or no further treatment if complete response ( CR ) was achieved .
-METHODS	RER without CR patients were non-randomly assigned to 21 Gy IFRT .
-METHODS	Relapses were characterized without respect to site ( initial , new , or both ; and initial bulk or initial nonbulk ) , and involved field radiation therapy field ( in-field , out-of-field , or both ) .
-METHODS	Patients were grouped by treatment assignment ( SER ; RER/no CR ; RER/CR/IFRT ; and RER/CR/no IFRT ) .
-METHODS	Summary statistics were reported .
-RESULTS	At 4-year median follow-up , 244 patients had experienced relapse , 198 of whom were fully evaluable for review .
-RESULTS	Those who progressed during treatment ( n = 30 ) or lacked relapse imaging ( n = 16 ) were excluded .
-RESULTS	The median time to relapse was 12.8 months .
-RESULTS	Of the 198 evaluable patients , 30 % were RER/no CR , 26 % were SER , 26 % were RER/CR/no IFRT , 16 % were RER/CR/IFRT , and 2 % remained uncategorized .
-RESULTS	The 74 % and 75 % relapses involved initially bulky and nonbulky sites , respectively .
-RESULTS	First relapses rarely occurred at exclusively new or out-of-field sites .
-RESULTS	By contrast , relapses usually occurred at nodal sites of initial bulky and nonbulky disease .
-CONCLUSIONS	Although response-based therapy has helped define treatment for selected RER patients , it has not improved outcome for SER patients or facilitated refinement of IFRT volumes or doses .
-
-###24680265
-OBJECTIVE	To explore the impact of intracoronary bolus administration of tirofiban combined with nitroprusside through thrombus aspiration catheter or thrombus aspiration alone on myocardial reperfusion and major adverse cardiovascular events rate in acute anterior myocardial infarction patients with heavy thrombosis burden .
-METHODS	Ninety consecutive acute anterior myocardial infarction patients with heavy thrombosis burden [ ( 59.8 11.5 ) years old ] were randomly assigned to thrombus aspiration group ( Group A , n = 30 ) , thrombus aspiration and intracoronary tirofiban bolus ( 25 g/kg prior to the first balloon inflation , Group B , n = 30 ) , thrombus aspiration and intracoronary tirofiban combined with nitroprusside bolus ( 200 g prior to the first balloon inflation , Group C , n = 30 ) with random number table .
-METHODS	Baseline clinical data , angiographic features before and after percutaneous coronary intervention ( PCI ) and major adverse cardiovascular events after PCI between 3 groups were compared .
-RESULTS	The baseline clinical data and angiographic features among 3 groups were similar ( all P > 0.05 ) .
-RESULTS	The time of pain to balloon was ( 5.5 3.8 ) hours .
-RESULTS	After primary PCI , myocardial tissue perfusion was significantly better in Group C than in Group A and Group B : TMP grade < 3 [ 10.0 % ( 3/30 ) vs. 40.0 % ( 12/30 ) and 33.3 % ( 10/30 ) , P < 0.01 and P < 0.05 ] .
-RESULTS	Left ventricular ejection fraction at 5 to 7 days after PCI also tended higher in Group C than in the other 2 groups ( P = 0.05 ) .
-RESULTS	One patient died of heart failure at 7th day after PCI in Group A , and no patient died in Group B and C. Thirty days after PCI , there was no re-myocardial infarction and target vessel revascularization event among 3 groups .
-RESULTS	The bleeding complication rate during 30 days follow-up was similar among 3 groups ( P > 0.05 ) .
-CONCLUSIONS	Intracoronary bolus application of tirofiban combined with nitroprusside through thrombus aspiration catheter after thrombus aspiration is associated with an improvement of myocardial reperfusion without increasing bleeding complication and other adverse cardiovascular events rate compared with thrombus aspiration alone in patients with acute anterior myocardial infarction and heavy thrombosis burden undergoing primary PCI .
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-###25986590
-BACKGROUND	Lithium has proven suicide preventing effects in the long-term treatment of patients with affective disorders .
-BACKGROUND	Clinical evidence from case reports indicate that this effect may occur early on at the beginning of lithium treatment .
-BACKGROUND	The impact of lithium treatment on acute suicidal thoughts and/or behavior has not been systematically studied in a controlled trial .
-BACKGROUND	The primary objective of this confirmatory study is to determine the association between lithium therapy and acute suicidal ideation and/or suicidal behavior in inpatients with a major depressive episode ( MDE , unipolar and bipolar disorder according to DSM IV criteria ) .
-BACKGROUND	The specific aim is to test the hypothesis that lithium plus treatment as usual ( TAU ) , compared to placebo plus TAU , results in a significantly greater decrease in suicidal ideation and/or behavior over 5weeks in inpatients with MDE .
-METHODS	We initiated a randomized , placebo-controlled multicenter trial .
-METHODS	Patients with the diagnosis of a moderate to severe depressive episode and suicidal thoughts and/or suicidal behavior measured with the Sheehan-Suicidality-Tracking Scale ( S-STS ) will be randomly allocated to add lithium or placebo to their treatment as usual .
-METHODS	Change in the clinician administered S-STS from the initial to the final visit will be the primary outcome .
-CONCLUSIONS	There is an urgent need to identify treatments that will acutely decrease suicidal ideation and/or suicidal behavior .
-CONCLUSIONS	The results of this study will demonstrate whether lithium reduces suicidal ideation and behavior within the first 5weeks of treatment .
-BACKGROUND	ClinicalTrials.gov identifier : NCT02039479 .
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-###24656478
-OBJECTIVE	To study the impact of impaired cerebral autoregulation on cortical neurophysiology , long term potentiation ( LTP ) - like plasticity , motor learning and brain structure .
-METHODS	12 patients with unilateral occlusion or severe stenosis of the internal carotid artery were included .
-METHODS	Impairment of cerebral autoregulation was determined by vasomotor reactivity in transcranial Doppler sonography .
-METHODS	Corticomotor excitability , cortical silent period and LTP-like plasticity were assessed with transcranial magnetic stimulation , motor learning with a force production task , and brain structure with high-resolution MRI of the brain .
-RESULTS	In the affected hemisphere , corticomotor excitability was significantly higher , cortical silent period and LTP-like plasticity significantly lower , compared to the contralateral side .
-RESULTS	No significant difference emerged for motor learning , cortical thickness and white matter integrity between the hemispheres .
-CONCLUSIONS	Despite decreased LTP-like plasticity in the affected hemisphere , motor learning was comparable between hemispheres , possibly due to gamma-aminobutyric-acid ( GABA ) B-mediated corticomotor excitability changes within the affected hemisphere .
-CONCLUSIONS	Our results may help to develop interventions to beneficially modulate cortical physiology in the presence of cerebral hypoperfusion .
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-###24765899
-OBJECTIVE	Pain after total knee arthroplasty ( TKA ) is severe , thus adequate pain control can be a challenge .
-OBJECTIVE	Intrathecal morphine ( ITM ) provides excellent postoperative analgesia for TKA , but may have side effects .
-OBJECTIVE	Femoral nerve block ( FNB ) also has been used for postoperative analgesia in TKA .
-OBJECTIVE	We examined postoperative analgesia efficacy and side effects of ITM combined with single shot femoral nerve block ( SSFNB ) after TKA , over the dosage range of 0.0 to 0.3 mg .
-METHODS	Sixty patients undergoing elective TKA received SSFNB ( 0.5 % bupivacaine 20 ml ) and spinal anesthesia with 15 mg of hyperbaric bupivacaine ( 0.5 % Heavy Marcaine ) were included in this study .
-METHODS	They were randomized to receive ITM ( 0 , 0.1 , 0.2 , and 0.3 mg ) .
-METHODS	A patient-controlled analgesia ( PCA ) device provided additional intravenous morphine .
-METHODS	Morphine consumption , pain score , and side effects were recorded at 0 , 1 , 4 , 8 , 12 , and 24 hour postoperative .
-METHODS	Patient satisfaction was rated at the 24-hour postoperative visit .
-RESULTS	Morphine consumption was significant higher in 0 mg ITM group ( control ) than other groups , but there was no difference between ITM groups .
-RESULTS	Pain score was significant lower in 0.3 mg ITM group compared to 0 mg at 1 hour ( 0.5 vs. 3.5 , respectively ; p-value = 0.013 ) and 4 hour ( 1.5 vs. 4.5 , respectively ; p-value = 0.037 ) postoperative period Side effects were not different in all groups .
-CONCLUSIONS	The present study concluded that , low-dose ITM combination with SSFNB provided good pain relief with low side effects and reduced morphine consumption during the first 24 hours post TKA .
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-###24472614
-OBJECTIVE	To evaluate the effects of transcranial direct current stimulation ( tDCS ) on esophageal peristalsis in patients with gastroesophageal reflux disease ( GERD ) .
-METHODS	Patients with GERD preliminary diagnosis were included in a randomized double-blind sham-controlled study .
-METHODS	Esophageal manometry was performed before and during transcranial direct current stimulation ( tDCS ) of the right precentral cortex .
-METHODS	Half of patients were randomly assigned to anodal , half to sham stimulation .
-METHODS	Distal waves amplitude and pathological waves percentage were measured , after swallowing water boli , for ten subsequent times .
-METHODS	Last , a 24h pH-bilimetry was done to diagnose non-erosive reflux disease ( NERD ) or functional heartburn ( FH ) .
-METHODS	The values obtained before and during anodal or sham tDCS were compared .
-RESULTS	Sixty-eight patients were enrolled in the study .
-RESULTS	Distal waves mean amplitude increased significantly only during anodal tDCS in NERD ( p = 0.00002 ) and FH subgroups ( p = 0.008 ) while percentage of pathological waves strongly decreased only in NERDs ( p = 0.002 ) .
-CONCLUSIONS	Transcranial stimulation can influence cortical control of esophageal motility and improve pathological motor pattern in NERD and FH but not in erosive reflux disease ( ERD ) patients .
-CONCLUSIONS	Pathophysiological processes in GERD are not only due to peripheral damage but to central neural control involvement as well .
-CONCLUSIONS	In ERD patients dysfunctions of the cortico-esophageal circuit seem to be more severe and may affect central nervous system physiology .
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-###25494864
-OBJECTIVE	The wide heterogeneity in the early growth and metabolism of children born small for gestational age ( SGA ) , both before and during GH therapy , may reflect common genetic variations related to insulin secretion or sensitivity .
-METHODS	Combined multiallele single nucleotide polymorphism scores with known associations with insulin sensitivity or insulin secretion were analyzed for their relationships with spontaneous postnatal growth and first-year responses to GH therapy in 96 short SGA children .
-RESULTS	The insulin sensitivity allele score ( GS-InSens ) was positively associated with spontaneous postnatal weight gain ( regression coefficient [ B ] : 0.12 SD scores per allele ; 95 % confidence interval [ CI ] , 0.01-0 .23 ; P = .03 ) and also in response to GH therapy with first-year height velocity ( B : 0.18 cm/y per allele ; 95 % CI , 0.02-0 .35 ; P = .03 ) and change in IGF-1 ( B : 0.17 SD scores per allele ; 95 % CI , 0.00-0 .32 ; P = .03 ) .
-RESULTS	The association with first-year height velocity was independent of reported predictors of response to GH therapy ( adjusted P = .04 ) .
-RESULTS	The insulin secretion allele score ( GS-InSec ) was positively associated with spontaneous postnatal height gain ( B : 0.15 ; 95 % CI , 0.01-0 .30 ; P = .03 ) and disposition index both before ( B : 0.02 ; 95 % CI , 0.00-0 .04 ; P = .04 ) and after 1 year of GH therapy ( B : 0.03 ; 95 % CI , 0.01-0 .05 ; P = .002 ) , but not with growth and IGF-1 responses to GH therapy .
-RESULTS	Neither of the allele scores was associated with size at birth .
-CONCLUSIONS	Genetic allele scores indicative of insulin sensitivity and insulin secretion were associated with spontaneous postnatal growth and responses to GH therapy in short SGA children .
-CONCLUSIONS	Further pharmacogenetic studies may support the rationale for adjuvant therapies by informing the mechanisms of treatment response .
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-###25521103
-BACKGROUND	Many new brands of hyaluronic acid ( HA ) fillers are being produced , but comparative research on the characteristics of similar products is limited .
-OBJECTIVE	To test the efficacy , tolerability , and safety of a new HA filler , PP-501-B ( Cleviel Contour ; Pacific Pharma , Seoul , Korea ) , which is used for correcting nasolabial folds ( NLFs ) , and to compare the performance of PP-501-B with that of Restylane Perlane ( Q-Med ) .
-METHODS	A total of 103 subjects with visible NLFs were enrolled in this randomized , multicenter , patient/evaluator-blind , active-controlled , matched-pair clinical study .
-METHODS	Each subject was injected with PP-501-B in 1 NLF and Restylane Perlane in the other .
-METHODS	All participants were reassessed for cosmetic changes at 8 , 16 , and 24 weeks .
-METHODS	Wrinkle severity was rated using the 5-point Wrinkle Severity Rating Scale ( WSRS ) .
-RESULTS	At Week 24 , the mean improvement in the WSRS compared with baseline was 1.87 0.73 for the PP-501-B side and 1.92 0.71 for the Restylane Perlane side .
-RESULTS	Both fillers were well tolerated , and adverse reactions were mild .
-CONCLUSIONS	The new HA filler , PP-501-B , to the market , with suitable characteristics and ample safety profiles , will widen the selection of agents for physicians and patients because the purpose , area , and depth of filler injections vary .
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-###24268369
-OBJECTIVE	The effect of weight loss by diet or diet and exercise on salivary cortisol levels , a measure of hypothalamic pituitary adrenal activity , in overweight individuals is not known .
-OBJECTIVE	The objective was to test the hypothesis that 24 weeks of moderate caloric restriction ( CR ) ( 25 % ) by diet or diet and aerobic exercise would alter morning and diurnal salivary cortisol levels .
-METHODS	Randomized control trial in an institutional research center .
-METHODS	Thirty-five overweight ( BMI : 27.80.7 kg/m ( 2 ) ) but otherwise healthy participants ( 16 M/19 F ) .
-METHODS	Participants were randomized to either calorie restriction ( CR : 25 % reduction in energy intake , n = 12 ) , calorie restriction + exercise ( CR+EX : 12.5 % reduction in energy intake +12.5 % increase in exercise energy expenditure , n = 12 ) or control ( healthy weight-maintenance diet , n = 11 ) for 6 months .
-METHODS	Salivary cortisol measured at 8:00 , 8:30 , 11:00 , 11:30 , 12:30 , 13:00 , 16:00 and 16:30 .
-METHODS	Morning cortisol was defined as the mean cortisol concentration at 08:00 and 08:30 .
-METHODS	Diurnal cortisol was calculated as the mean of the 8 cortisol measures across the day .
-RESULTS	In the whole cohort , higher morning and diurnal cortisol levels were associated with impaired insulin sensitivity ( morning : P = 0.004 , r ( 2 ) = 0.24 ; diurnal : P = 0.02 , r ( 2 ) = 0.15 ) .
-RESULTS	Using mixed model analysis , there was no significant effect of group , time or sex on morning or diurnal cortisol levels .
-CONCLUSIONS	A 10 % weight loss with a 25 % CR diet alone or with exercise did not impact morning or diurnal salivary cortisol levels .
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-###24806033
-BACKGROUND	Triple therapy with telaprevir ( TVR ) , pegylated interferon and ribavirin has improved antiviral efficacy in patients with chronic hepatitis C ( CH-C ) .
-BACKGROUND	However , the severe adverse effects caused by TVR are important to resolve .
-BACKGROUND	In this prospective , randomized , multicenter , open-label study , the antiviral efficacy and safety in the reduced administration of TVR were examined .
-METHODS	A total of 81 CH-C Japanese patients with HCV genotype 1 were randomized into two regimens of TVR 2250 mg ( TVR-2250 ) or 1500 mg ( TVR-1500 ) and treated with triple therapy for 24 weeks .
-RESULTS	The mean HCV RNA at start , 2 and 4 weeks of treatment were 6.69 0.70 , 1.05 0.74 , 0.22 0.48 log10 IU/ml in the TVR-2250 group and 6.70 0.62 , 1.02 0.62 , 0.13 0.41 log10 IU/ml in the TVR-1500 group .
-RESULTS	The SVR rates were 85 % in both groups ( 35/41 and 34/40 , respectively ) .
-RESULTS	There were no patients with viral breakthrough in either group .
-RESULTS	As for adverse effects , rash more than moderate and severe anemia with < 8.5 g/dl of hemoglobin were higher in the TVR-2250 group than in the TVR-1500 group ( p = 0.046 , p < 0.001 , respectively ) .
-RESULTS	The increase in serum creatinine levels and decrease in estimated glomerular filtration rates were higher in the TVR-2250 group than in the TVR-1500 group .
-CONCLUSIONS	The lower dose of TVR ( 1500 mg/day ) can result in similar SVR rates and lower treatment-related adverse effects compared to the higher dose of TVR ( 2250 mg/day ) in triple therapy ( UMIN : 000007313 , 000007330 ) .
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-###24312456
-OBJECTIVE	This study investigates utilisation patterns for prescription opioid analgesics in the Australian community and how these are associated with a framework of individual-level factors related to healthcare use .
-METHODS	Self-reported demographic and health information from participants in the 45 and Up Study cohort were linked to pharmaceutical claims from 2006-2009 .
-METHODS	Participants comprised 19,816 people with 1 opioid analgesic dispensing in the 12-months after recruitment to the cohort and 79,882 people not dispensed opioid analgesics .
-METHODS	All participants were aged 45 years , were social security pharmaceutical beneficiaries , with no history of cancer .
-METHODS	People dispensed opioid analgesics were classified as having acute ( dispensing period < 90 days ) , episodic ( 90 days and < 3 ` authority ' prescriptions for increased quantity supply ) or long-term treatment ( 90 days and 3 authority prescriptions ) .
-RESULTS	Of participants dispensed opioid analgesic 52 % received acute treatment , 25 % episodic treatment and 23 % long-term treatment .
-RESULTS	People dispensed opioid analgesics long-term had an average of 14.9 opioid analgesic prescriptions/year from 2.0 doctors compared with 1.5 prescriptions from 1.1 doctors for people receiving acute treatment .
-RESULTS	People dispensed opioid analgesics reported more need-related factors such as poorer physical functioning and higher psychological distress .
-RESULTS	Long-term users were more likely to have access-related factors such as low-income and living outside major cities .
-RESULTS	After simultaneous adjustment , association with predisposing health factors and access diminished , but indicators of need such as osteoarthritis treatment , paracetamol use , and poor physical function were the strongest predictors for all opioid analgesic users .
-CONCLUSIONS	People dispensed opioid analgesics were in poorer health , reported higher levels of distress and poorer functioning than people not receiving opioid analgesics .
-CONCLUSIONS	Varying dispensing profiles were evident among people dispensed opioid analgesics for persistent pain , with those receiving episodic and long-term treatment dispensed the strongest opioid analgesics .
-CONCLUSIONS	The findings highlight the broad range of factors associated with longer term opioid analgesics use .
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-###25691510
-OBJECTIVE	Primary percutaneous coronary intervention ( P-PCI ) is the preferred reperfusion option in ST-elevation myocardial infarction , but its benefits become attenuated as time to its potential delivery becomes prolonged .
-OBJECTIVE	Based on the STrategic Reperfusion Early After Myocardial Infarction trial , we assessed the impact of increasing time delay on outcomes in patients randomised to a pharmacoinvasive strategy ( PI ) or P-PCI .
-METHODS	Thirty-day clinical outcomes were examined according to PCI-related delay ( P-RD ) .
-METHODS	Data from hospitals that enrolled > 10 randomised patients were used and P-RD categorised as 55min , > 55-97min and > 97min .
-RESULTS	Composite of death/congestive heart failure/cardiogenic shock/myocardial infarction in PI and P-PCI arms occurred in 10.6 % versus 10.3 % ( 55min , p = 0.910 ) ; 13.9 % versus 17.9 % ( > 55-97min , p = 0.148 ) and 13.5 % versus 16.2 % ( > 97min , p = 0.470 ) , respectively .
-RESULTS	While there was no worsening of outcomes for PI across the P-RD spectrum , this occurred in the P-PCI arm ( p ( trend ) = 0.038 ) .
-RESULTS	For P-RD 55min , fewer events tended to occur with P-PCI than PI .
-RESULTS	Conversely , as P-RD increased to > 55min , PI-assigned patients had better outcomes than P-PCI , suggesting an event-free advantage with PI as P-RD increased ( p ( interaction ) = 0.094 ) .
-RESULTS	Analysing P-RD continuously showed that for every 10-min increment there was an increasing trend towards benefit among PI-assigned patients ( p ( interaction ) = 0.073 ) .
-CONCLUSIONS	As P-RD increased , PI outcomes became superior to P-PCI when P-RD is prolonged and exceeds guideline-mandated times .
-CONCLUSIONS	In such circumstances , a PI strategy may provide an alternative reperfusion option .
-CONCLUSIONS	Adverse time delays for delivery of P-PCI should be considered when evaluating reperfusion strategies .
-BACKGROUND	NCT00623623 .
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-###24292489
-OBJECTIVE	Bleeding after haemorrhoidectomy is common .
-OBJECTIVE	Many surgical textbooks recommend insertion of an anal tampon in order to reduce postoperative bleeding .
-OBJECTIVE	This practice , however , is bothersome and probably painful for patients .
-OBJECTIVE	The effect of using a tamponade has not been validated in randomised controlled trials .
-METHODS	The study included 100 patients who were scheduled for Milligan-Morgan haemorrhoidectomy .
-METHODS	During surgery , patients were randomly assigned to receive or not to receive an anal tampon at the end of the procedure .
-METHODS	Data on pain , complications and wound care were collected .
-METHODS	The trial was registered ( DRKS00003116 ) and all analyses were by intention-to-treat .
-RESULTS	There were 48 patients in the group with tamponade , and 52 patients were left without tamponade .
-RESULTS	The trial 's primary outcome and maximum pain intensity , averaged 6.1 and 4.2 in the two groups ( P = 0.001 ) .
-RESULTS	In the group with tamponade , a complication was recorded in seven patients ( 15 % ) , which was similar to the group without tamponade ( 21 % ) .
-RESULTS	Severe anal bleeding occurred in two and five patients , respectively .
-RESULTS	Bandage changes were less necessary often in the group treated without tamponade ( P = 0.013 ) .
-RESULTS	Hospital stay was 4 days in both groups .
-CONCLUSIONS	Data indicate that insertion of an anal tampon after haemorrhoidectomy does not reduce postoperative bleeding but causes significantly more pain .
-CONCLUSIONS	After haemorrhoidectomy , anal tampons should not be used routinely but may be considered when specific indications justify its use .
-
-###25420618
-OBJECTIVE	Acute changes in social belonging are important triggers for alterations in health and well-being , yet research has emphasised the negative effects of ` exclusion ' at the expense of evaluating the potentially positive effects of ` inclusion ' .
-OBJECTIVE	This study examined the impact of acute belonging on physiological and psychological outcomes .
-METHODS	A healthy population ( N = 138 ) were randomly allocated to ` included ' or ` excluded ' conditions .
-METHODS	Condition-dependent differences in pre/during-task heart rate and pre/post-task self-reports of negative/positive mood , and social self-esteem , were assessed .
-RESULTS	Included participants showed decreased heart rate and negative mood , and increased social self-esteem .
-RESULTS	No inclusion-related change in positive mood was shown .
-RESULTS	An increase in heart rate was observed in excluded participants though no changes in negative/positive mood or social self-esteem were shown .
-RESULTS	Shifts in social self-esteem acted as a mechanism through which inclusion/exclusion impacted upon negative and positive mood alterations .
-RESULTS	Results remained significant in presence of covariates ( sex , global self-esteem , rumination and social anxiety ) .
-CONCLUSIONS	Findings suggest that acting to enhance belonging through ` inclusion ' resulted in adaptive physiological and psychological outcomes .
-CONCLUSIONS	Neutral and potentially protective responses were observed in the immediate aftermath of ` exclusion ' .
-CONCLUSIONS	Self-esteem served as one route through which these effects were transmitted .
-
-###26193126
-BACKGROUND	In sub-Saharan Africa , the burden of human immunodeficiency virus ( HIV ) - associated tuberculosis is high .
-BACKGROUND	We conducted a trial with a 2-by-2 factorial design to assess the benefits of early antiretroviral therapy ( ART ) , 6-month isoniazid preventive therapy ( IPT ) , or both among HIV-infected adults with high CD4 + cell counts in Ivory Coast .
-METHODS	We included participants who had HIV type 1 infection and a CD4 + count of less than 800 cells per cubic millimeter and who met no criteria for starting ART according to World Health Organization ( WHO ) guidelines .
-METHODS	Participants were randomly assigned to one of four treatment groups : deferred ART ( ART initiation according to WHO criteria ) , deferred ART plus IPT , early ART ( immediate ART initiation ) , or early ART plus IPT .
-METHODS	The primary end point was a composite of diseases included in the case definition of the acquired immunodeficiency syndrome ( AIDS ) , non-AIDS-defining cancer , non-AIDS-defining invasive bacterial disease , or death from any cause at 30 months .
-METHODS	We used Cox proportional models to compare outcomes between the deferred-ART and early-ART strategies and between the IPT and no-IPT strategies .
-RESULTS	A total of 2056 patients ( 41 % with a baseline CD4 + count of 500 cells per cubic millimeter ) were followed for 4757 patient-years .
-RESULTS	A total of 204 primary end-point events were observed ( 3.8 events per 100 person-years ; 95 % confidence interval [ CI ] , 3.3 to 4.4 ) , including 68 in patients with a baseline CD4 + count of at least 500 cells per cubic millimeter ( 3.2 events per 100 person-years ; 95 % CI , 2.4 to 4.0 ) .
-RESULTS	Tuberculosis and invasive bacterial diseases accounted for 42 % and 27 % of primary end-point events , respectively .
-RESULTS	The risk of death or severe HIV-related illness was lower with early ART than with deferred ART ( adjusted hazard ratio , 0.56 ; 95 % CI , 0.41 to 0.76 ; adjusted hazard ratio among patients with a baseline CD4 + count of 500 cells per cubic millimeter , 0.56 ; 95 % CI , 0.33 to 0.94 ) and lower with IPT than with no IPT ( adjusted hazard ratio , 0.65 ; 95 % CI , 0.48 to 0.88 ; adjusted hazard ratio among patients with a baseline CD4 + count of 500 cells per cubic millimeter , 0.61 ; 95 % CI , 0.36 to 1.01 ) .
-RESULTS	The 30-month probability of grade 3 or 4 adverse events did not differ significantly among the strategies .
-CONCLUSIONS	In this African country , immediate ART and 6 months of IPT independently led to lower rates of severe illness than did deferred ART and no IPT , both overall and among patients with CD4 + counts of at least 500 cells per cubic millimeter .
-CONCLUSIONS	( Funded by the French National Agency for Research on AIDS and Viral Hepatitis ; TEMPRANO ANRS 12136 ClinicalTrials.gov number , NCT00495651 . )
-
-###24710341
-OBJECTIVE	1 ) To investigate the impact of acetazolamide , a drug commonly prescribed for altitude sickness , on cortical oscillations in patients with obstructive sleep apnea syndrome ( OSAS ) .
-OBJECTIVE	2 ) To examine alterations in the sleep EEG after short-term discontinuation of continuous positive airway pressure ( CPAP ) therapy .
-METHODS	Data from two double-blind , placebo-controlled randomized cross-over design studies were analyzed .
-METHODS	Polysomnographic recordings in sleep laboratory at 490 m and at moderate altitudes in the Swiss Alps : 1630 or 1860 m and 2590 m.
-METHODS	Study 1 : 39 OSAS patients .
-METHODS	Study 2 : 41 OSAS patients .
-METHODS	Study 1 : OSAS patients withdrawn from treatment with CPAP .
-METHODS	Study 2 : OSAS patients treated with autoCPAP .
-METHODS	Treatment with acetazolamide ( 500-750 mg ) or placebo at moderate altitudes .
-RESULTS	An evening dose of 500 mg acetazolamide reduced slow-wave activity ( SWA ; approximately 10 % ) and increased spindle activity ( approximately 10 % ) during non-REM sleep .
-RESULTS	In addition , alpha activity during wake after lights out was increased .
-RESULTS	An evening dose of 250 mg did not affect these cortical oscillations .
-RESULTS	Discontinuation of CPAP therapy revealed a reduction in SWA ( 5-10 % ) and increase in beta activity ( approximately 25 % ) .
-CONCLUSIONS	The higher evening dose of 500 mg acetazolamide showed the `` spectral fingerprint '' of Benzodiazepines , while 250 mg acetazolamide had no impact on cortical oscillations .
-CONCLUSIONS	However , both doses had beneficial effects on oxygen saturation and sleep quality .
-
-###24654636
-BACKGROUND	Adolescent mothers living with their mothers may be at greater risk of early weaning .
-BACKGROUND	This study aims to assess the influence of a breastfeeding promotion strategy directed at adolescent mothers living with their mothers on the prevalence of breastfeeding in the first year of life .
-METHODS	A randomized clinical trial with 323 adolescent mothers .
-METHODS	Participants were divided into two groups : those who lived with their mothers and those who did not .
-METHODS	Participants were randomly assigned to control or intervention groups .
-METHODS	Intervention consisted of breastfeeding counseling sessions held at the maternity ward and at home ( at 7 , 15 , 30 , 60 , and 120 days postpartum ) .
-METHODS	The intervention effect was assessed by comparing survival curves for breastfeeding in the first 12 months of life .
-RESULTS	The risk of weaning before 12 months of age was significantly lower in the intervention group for adolescent mothers not living with their mothers ; whereas the risk was not statistically different between intervention and control groups for those living with their mothers .
-CONCLUSIONS	The positive influence of systematic counseling sessions on the prevalence of breastfeeding in the first year of life was significant for adolescent mothers .
-CONCLUSIONS	Living with their mothers reduced such influence .
-
-###24617605
-OBJECTIVE	Rosuvastatin and pitavastatin have been proposed as probe substrates for the organic anion-transporting polypeptide ( OATP ) 1B , but clinical data on their relative sensitivity and selectivity to OATP1B inhibitors are lacking .
-OBJECTIVE	A clinical study was therefore conducted to determine their relative suitability as OATP1B probes using single oral ( PO ) and intravenous ( IV ) doses of the OATP1B inhibitor rifampicin , accompanied by a comprehensive in vitro assessment of rifampicin inhibitory potential on statin transporters .
-METHODS	The clinical study comprised of two separate panels of eight healthy subjects .
-METHODS	In each panel , subjects were randomized to receive a single oral dose of rosuvastatin ( 5mg ) or pitavastatin ( 1mg ) administered alone , concomitantly with rifampicin ( 600mg ) PO or IV .
-METHODS	The in vitro transporter studies were performed using hepatocytes and recombinant expression systems .
-RESULTS	Rifampicin markedly increased exposures of both statins , with greater differential increases after POvs.IV rifampicin only for rosuvastatin .
-RESULTS	The magnitudes of the increases in area under the plasma concentration-time curve were 5.7 - and 7.6-fold for pitavastatin and 4.4 - and 3.3-fold for rosuvastatin , after PO and IV rifampicin , respectively .
-RESULTS	In vitro studies showed that rifampicin was an inhibitor of OATP1B1 and OATP1B3 , breast cancer resistance protein and multidrug resistance protein 2 , but not of organic anion transporter 3 .
-CONCLUSIONS	The results indicate that pitavastatin is a more sensitive and selective and thus preferred clinical OATP1B probe substrate than rosuvastatin , and that a single IV dose of rifampicin is a more selective OATP1B inhibitor than a PO dose .
-
-###25185281
-OBJECTIVE	To evaluate the efficacy of mite allergen specific immunotherapy ( SIT ) to patients of allergic rhinitis .
-METHODS	A total of 102 patients with mite allergy were recruited into the study .
-METHODS	They were randomly divided into two groups : SIT group ( n = 51 ) and ST ( symptomatic therapy ) group ( n = 51 ) .
-METHODS	They were given SIT with standardized allergen vaccine for 3 years or only symptomatic therapy respectively .
-METHODS	Observation items include : rhinitis symptom scores , drug score , skin prick test result , serum specificity IgE ( sIgE ) , peripheral eosinophil counting .
-METHODS	The development of asthma and new allergens sensitization was also assessed .
-RESULTS	The blood eosinophil numbers , skin test index , rhinitis symptom scores and drug scores were all decreased significantly after the treatment with SIT for 3 years compared to that of ST group ( P < 0.01 ) .
-RESULTS	Although the level of serum slgE was decreased , no statistic diferences were found .
-RESULTS	No patients developed asthma in SIT group , and only 2.1 % of patients had new allergen sensitization ; 17.4 % of those in ST group developed asthma , 32.6 % had new sensitization .
-RESULTS	No severe adverse events occurred .
-CONCLUSIONS	Keeping long-term SIT is effective and safe for patients with allergic rhinitis induced by mite , which can also prevent new allergen sensitization and development for asthma .
-
-###25445556
-OBJECTIVE	The ARO 96-02 trial primarily compared wait-and-see ( WS , arm A ) with adjuvant radiation therapy ( ART , arm B ) in prostate cancer patients who achieved an undetectable prostate-specific antigen ( PSA ) after radical prostatectomy ( RP ) .
-OBJECTIVE	Here , we report the outcome with up to 12 years of follow-up of patients who retained a post-RP detectable PSA and received salvage radiation therapy ( SRT , arm C ) .
-METHODS	For the study , 388 patients with pT3-4pN0 prostate cancer with positive or negative surgical margins were recruited .
-METHODS	After RP , 307 men achieved an undetectable PSA ( arms A + B ) .
-METHODS	In 78 patients the PSA remained above thresholds ( median 0.6 , range 0.05-5 .6 ng/mL ) .
-METHODS	Of the latter , 74 consented to receive 66 Gy to the prostate bed , and SRT was applied at a median of 86 days after RP .
-METHODS	Clinical relapse-free survival , metastasis-free survival , and overall survival were determined by the Kaplan-Meier method .
-RESULTS	Patients with persisting PSA after RP had higher preoperative PSA values , higher tumor stages , higher Gleason scores , and more positive surgical margins than did patients in arms A + B. For the 74 patients , the 10-year clinical relapse-free survival rate was 63 % .
-RESULTS	Forty-three men had hormone therapy ; 12 experienced distant metastases ; 23 patients died .
-RESULTS	Compared with men who did achieve an undetectable PSA , the arm-C patients fared significantly worse , with a 10-year metastasis-free survival of 67 % versus 83 % and overall survival of 68 % versus 84 % , respectively .
-RESULTS	In Cox regression analysis , Gleason score 8 ( hazard ratio [ HR ] 2.8 ) , pT 3c ( HR 2.4 ) , and extraprostatic extension 2 mm ( HR 3.6 ) were unfavorable risk factors of progression .
-CONCLUSIONS	A persisting PSA after prostatectomy seems to be an important prognosticator of clinical progression for pT3 tumors .
-CONCLUSIONS	It correlates with a higher rate of distant metastases and with worse overall survival .
-CONCLUSIONS	A larger prospective study is required to determine which patient subgroups will benefit most from which treatment option .
-
-###24472270
-OBJECTIVE	Knee osteoarthritis ( OA ) , is the most common degenerative joint disease .
-OBJECTIVE	Several non-pharmacological interventions have been used for this purpose such as insoles .
-OBJECTIVE	There are contradictory data about the superiority and effectiveness of laterally wedged compared with neutrally wedged insoles .
-OBJECTIVE	This study was designed to compare the effectiveness of laterally and neutrally wedged insoles in management of knee OA .
-METHODS	In this double-blind , parallel treatment trial , 118 patients with knee OA according to American College of Rheumatology ( ACR ) criteria were enrolled and were followed for 2months .
-METHODS	Patients were randomly divided into two groups .
-METHODS	Fifty-seven of them were treated with 5 laterally elevated wedged insoles ( group A ) and 61 patients were treated with neutrally wedged insoles ( group B ) .
-METHODS	Edinburg Knee Functional Scale ( EKFS ) was used to evaluate knee function before and after interventions .
-METHODS	At the end of 2months , severity of knee pain during the previous 2days , numbers of non-steroid anti inflammatory drugs ( NSAIDs ) used for pain relief within the last 2weeks and EKFS were assessed .
-RESULTS	Severity of knee pain decreased in both groups after intervention .
-RESULTS	The mean difference in groups A ( laterally wedged insole ) and B ( neutrally wedged insole ) were 29.3 ( 95 % confidence interval [ 95 % CI ] : 25.12 , 33.55 ) and 6.25 ( 95 % CI : 3.09 , 9.4 ) , respectively ( P < 0.001 for both ) .
-RESULTS	In addition , at the end of the study , EKFS improved significantly in group A ( mean : 7.54 , 95 % CI : 6.3 , 8.8 ; P < 0.001 ) , while in group B we could not find significant improvement ( mean : 0.54 , 95 % CI : -0.41 , 1.5 ; P = 0.166 ) .
-RESULTS	Numbers of NSAIDs used during the two final weeks of the study significantly decreased compared with baseline in group A ( P = 0.001 ; mean : 2.6 , 95 % CI : 1.3 , 3.9 ) ; while in group B this was not shown ( P = 0.9 ; mean : 0.05 , 95 % CI : -0.87 , 0.97 ) .
-CONCLUSIONS	This study suggests that laterally elevated wedged insoles are more effective than neutrally wedged insoles , in pain relief of knee OA .
-
-###25099322
-METHODS	A prospective randomized controlled trial .
-OBJECTIVE	The purpose of this study was to prospectively compare the efficacy of neurophysiological monitoring during general anesthesia with either a total intravenous technique or with the volatile anesthetic agent , desflurane .
-BACKGROUND	A total intravenous anesthetic technique is generally chosen when neurophysiological monitoring is used as it has been shown to facilitate such monitoring .
-BACKGROUND	Despite this , with prolonged infusions of propofol , prolonged awakening times may be seen , which may impact the time required for postoperative neurological assessment or more importantly result in significant delays , should a wake-up test become necessary .
-BACKGROUND	To date , there are no prospective trials comparing intravenous techniques with a volatile agent-based anesthetic technique and its effects on neurophysiological monitoring .
-METHODS	This prospective study compares somatosensory evoked potential and motor evoked potential monitoring during posterior spinal fusion in 30 adolescents .
-METHODS	The patients were randomized to receive a total intravenous technique with propofol-remifentanil or a volatile agent-based technique with desflurane-remifentanil .
-RESULTS	The groups were similar with regard to age , weight , height , body mass index , Cobb angle , and distribution of Lenke classifications .
-RESULTS	No differences were noted in anesthesia time , surgery time , intraoperative fluids , or estimated blood loss between the 2 groups .
-RESULTS	Time to eye opening , time to following commands , and time to tracheal extubation were shorter in the volatile anesthesia group than the total intravenous anesthesia group .
-RESULTS	No clinically significant difference was noted in the amplitude or latency of somatosensory evoked potential monitoring .
-RESULTS	Although statistically significantly greater voltage amplitude was required to generate a motor evoked potential , the voltage amount was within a clinically acceptable range .
-CONCLUSIONS	Our data demonstrate that a volatile agent-based anesthetic regimen is feasible even during neurophysiological monitoring .
-CONCLUSIONS	Advantages include a more rapid awakening and the feasibility of a rapid wake-up test ( < 5 min ) in the event that irreversible changes in neurophysiological monitoring are noted .
-METHODS	2 .
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-###24519631
-OBJECTIVE	This randomized trial aimed to evaluate the effects of adding continuous epidural analgesia with a bupivacaine and hydromorphone solution to systemic multimodal analgesia following one - or two-level lumbar spinal fusion .
-METHODS	Thirty-nine patients undergoing lumbar spinal fusion , stratified for sex and one - or two-level fusion , were randomized to receive a continuous postoperative epidural infusion of either 0.1 % bupivacaine with 15gmL ( -1 ) hydromorphone ( LA group ) or 0.9 % saline ( NS group ) at 6mLhr ( -1 ) for 48hr through an epidural catheter placed intraoperatively .
-METHODS	All patients received a standardized postoperative multimodal analgesia regimen .
-METHODS	Patients , healthcare providers , and research staff were blinded .
-METHODS	The primary outcome measure was cumulative opioid consumption ( oral morphine equivalent ) during the first 48hr postoperatively .
-RESULTS	The mean ( SD ) cumulative opioid consumption 48hours postoperatively was 249.3 ( 143.3 ) mg in the NS group and 184.7 ( 208.1 ) mg in the LA group ( mean difference 64.6 mg ; 95 % confidence interval -54.3 to 183.5 ; P = 0.27 ) .
-RESULTS	There were no adverse events in either group .
-CONCLUSIONS	Continuous epidural infusion combined with systemic multimodal analgesia resulted in a mean reduction in 48-hr cumulative opioid consumption of 64.6 mg ( 95 % confidence interval -54.3 to 183.5 ) following one - or two-level lumbar spinal fusion .
-CONCLUSIONS	This estimate of effect is imprecise , and the routine use of continuous epidural analgesia in this surgical population is not yet warranted .
-CONCLUSIONS	This trial was registered at www.clinicaltrials.gov : NCT00644111 .
-
-###25338248
-OBJECTIVE	To assess the efficacy of massage for decreasing occupational low back pain in workers of a Nursing team in an Emergency Room .
-METHODS	A randomized controlled trial , using a socio-demographic/morbidity questionnaire and a Pain Numeric Scale .
-METHODS	Forty-five subjects were randomly allocated for intervention ( G1 - Massage by acupressure ) , placebo group ( G2 - application of Garlium Arseneid Laser 904 nm turned off ) and control ( G3 - no intervention ) .
-RESULTS	The main triggering factor , as well as the worsening of pain , was the patient manipulation , both with a prevalence of 34.9 % .
-RESULTS	The main treatment for low back pain before this research was the use of medication , with a prevalence of 44.2 % .
-RESULTS	In accordance with a variance analysis , only G1 presented a significant statistical difference , with a better result after 12 sessions .
-RESULTS	Massage presented an enormous effect ( d = 4.59 ) , corresponding to 86 % of reduction in the pain level .
-CONCLUSIONS	Massage was effective to decrease occupational low back pain of those Nursing workers .
-
-###24980290
-OBJECTIVE	Olive oil protects against cardiovascular disease but the underlying mechanism is still unclear .
-OBJECTIVE	We speculated that olive oil could inhibitoxidative stress , which is believed to be implicated in the atherosclerotic process .
-RESULTS	Post-prandial oxidative stress and endothelial dysfunction were investigated in twenty-five healthy subjects who were randomly allocated in a cross-over design to a Mediterranean diet added with or without extra virgin olive oil ( EVOO , 10g ) ( first study , n = 25 ) or Mediterranean diet with EVOO ( 10g ) or corn oil ( 10g ) ( second study , n = 25 ) .
-RESULTS	Oxidative stress biomarkers including platelet reactive oxidant species ( ROS ) and 8-iso-PGF2-III , activity of NOX2 , the catalytic sub-unit of NADPH oxidase , as assessed in platelets and serum , serum vitamin E and endothelial dysfunction , were measured before and 2h after lunch .
-RESULTS	In the first study a significant increase of platelet ROS , 8-iso-PGF2-III , NOX2 activity , sE-selectin , sVCAM1 and a decrease of serum vitamin E were detected in controls but not when EVOO was included in the Mediterranean diet ; oxidative stress and endothelial dysfunction increase were also observed in the second study in subjects given corn oil .
-RESULTS	A significant correlation was found between NOX2 activity and platelet oxidative stress .
-RESULTS	Invitro study demonstrated that EVOO but not corn oil significantly decreased platelet and PMNs oxidative stress and NOX2 activity .
-CONCLUSIONS	The study provides the first evidence that post-prandial oxidative stress may be triggered by NOX2 up-regulation .
-CONCLUSIONS	EVOO but not corn oil , is able to counteract such phenomenon suggesting that addition of EVOO to a Mediterranean diet protects against post-prandial oxidative stress .
-
-###24225149
-BACKGROUND	Persistently poor glycemic control in adult type 1 diabetes patients is a common , complex , and serious problem initiating significant damage to the cardiovascular , renal , neural , and visual systems .
-BACKGROUND	Currently , there is a plethora of low-cost and free diabetes self-management smartphone applications available in online stores .
-OBJECTIVE	The aim of this study was to examine the effectiveness of a freely available smartphone application combined with text-message feedback from a certified diabetes educator to improve glycemic control and other diabetes-related outcomes in adult patients with type 1 diabetes in a two-group randomized controlled trial .
-METHODS	Patients were recruited through an online type 1 diabetes support group and letters mailed to adults with type 1 diabetes throughout Australia .
-METHODS	In a 6-month intervention , followed by a three-month follow-up , patients ( n = 72 ) were randomized to usual care ( control group ) or usual care and the use of a smartphone application ( Glucose Buddy ) with weekly text-message feedback from a Certified Diabetes Educator ( intervention group ) .
-METHODS	All outcome measures were collected at baseline and every three months over the study period .
-METHODS	Patients ' glycosylated hemoglobin levels ( HbA1c ) were measured with a blood test and diabetes-related self-efficacy , self-care activities , and quality of life were measured with online questionnaires .
-RESULTS	The mean age of patients was 35.20 years ( SD 10.43 ) ( 28 male , 44 female ) , 39 % ( 28/72 ) were male , and patients had been diagnosed with type 1 diabetes for a mean of 18.94 years ( SD 9.66 ) .
-RESULTS	Of the initial 72 patients , 53 completed the study ( 25 intervention , 28 control group ) .
-RESULTS	The intervention group significantly improved glycemic control ( HbA1c ) from baseline ( mean 9.08 % , SD 1.18 ) to 9-month follow-up ( mean 7.80 % , SD 0.75 ) , compared to the control group ( baseline : mean 8.47 % , SD 0.86 , follow-up : mean 8.58 % , SD 1.16 ) .
-RESULTS	No significant change over time was found in either group in relation to self-efficacy , self-care activities , and quality of life .
-CONCLUSIONS	In adjunct to usual care , the use of a diabetes-related smartphone application combined with weekly text-message support from a health care professional can significantly improve glycemic control in adults with type 1 diabetes .
-BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12612000132842 ; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000132842 ( Archived by WebCite at http://www.webcitation.org/6Kl4jqn5u ) .
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-###24842175
-BACKGROUND	Failed intubation may result in both increased morbidity and mortality .
-BACKGROUND	The combination of a video laryngoscope and a flexible tracheoscope used as a flexible video stylet may improve the success rate of securing a difficult airway .
-BACKGROUND	We tested the hypothesis that this combination is a feasible way to facilitate intubation in patients with a predicted difficult airway in that it will shorten intubation times and reduce the number of intubation attempts .
-METHODS	We conducted a randomized , prospective trial in 140 patients with anticipated difficult airways undergoing elective or urgent surgery .
-METHODS	After insertion of video laryngoscope , patients were randomly assigned to either having their tube placed with the use of a preformed stylet ( control group ) or with a flexible tracheoscope ( intervention group ) .
-METHODS	The primary outcome measures were time to successful intubation and number of intubation attempts .
-RESULTS	The number of intubations requiring 2 or more intubation attempts was similar in the 2 groups ( 14 % control vs 13 % intervention , P = 1.0 ) ; the number of patients requiring 3 or more intubation attempts was not significantly different ( 8.6 % control vs 1.4 % intervention , P = 0.12 ) .
-RESULTS	Distribution for time to intubation also did not differ between the control ( median of 66 seconds , interquartile range 47-89 ) and the intervention group ( median of 71 seconds , interquartile range 52-100 ; P = 0.35 ) .
-RESULTS	In the control group , 4 patients , all with cervical spine pathology , had the trachea intubated successfully with the video laryngoscope plus flexible tracheoscope after 3 failed attempts with video laryngoscope and rigid stylet .
-RESULTS	For these 4 patients , time from the decision to change the intubation method to successful intubation with a flexible tracheoscope was 36 14 seconds .
-RESULTS	Overall success probability for cervical spine patients was 100 % ( 20/20 ) in the intervention group and 80 % ( 16/20 ) in the control group , with an exact 95 % confidence interval for the difference of 1.4 % to 44 % , P = 0.04 .
-CONCLUSIONS	Flexible tracheoscope-assisted video laryngoscopic intubation is a feasible alternative to video laryngoscope only intubation in patients with predicted difficult airways .
-CONCLUSIONS	A flexible tracheoscope used in combination with video laryngoscope may also further increase the success rate of intubation in select patients with a proven difficult airway , particularly when in-line stabilization is required .
-
-###25336333
-BACKGROUND	Hypomethylating agents have demonstrated activity in patients with myelodysplastic syndrome ( MDS ) and acute myeloid leukemia ( AML ) .
-BACKGROUND	Preclinical and single-arm trials have suggested that adding histone deacetylase ( HDAC ) inhibitors may synergize the epigenetic modulation of hypomethylating agents and improve treatment results .
-METHODS	The objective of this study was to evaluate the possible benefit of adding valproic acid , an HDAC inhibitor , to decitabine in the treatment of MDS and AML .
-RESULTS	Patients with higher risk MDS or with AML aged 60 years were eligible .
-RESULTS	Patients were randomized in a Bayesian response-adaptive design to receive intravenous decitabine 20 mg/m ( 2 ) daily for 5 days or decitabine plus oral valproic acid 50 mg/kg daily for 7 days .
-RESULTS	Courses were repeated every 4 to 6 weeks .
-RESULTS	A maximum of 150 patients were to be treated .
-RESULTS	In total , 149 patients were treated on study , including 87 patients with MDS and 62 patients with AML .
-RESULTS	The median patient age was 69 years ( range , 20-89 years ; 42 % of patients were aged 70 years ) .
-RESULTS	Overall , 34 % of patients achieved complete remission , and 55 % had an objective response .
-RESULTS	The median survival was 11.9 months , and the estimated 2-year survival rate was 27 % .
-RESULTS	Outcome was not different with the addition of valproic acid to decitabine versus decitabine alone in relation to the rates of complete remission , overall response , or survival .
-RESULTS	Subset analyses did not demonstrate a benefit within the MDS or AML categories .
-RESULTS	Toxicities-particularly neurotoxicities-were higher with the combination arm .
-CONCLUSIONS	Adding valproic acid to decitabine was not associated with improved outcome in the treatment of patients with MDS or elderly patients with AML .
-CONCLUSIONS	Future therapies may consider combining hypomethylating agents with better HDAC inhibitors and using different schedules .
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-###24608494
-OBJECTIVE	To compare the effects and short-term outcomes of pressure support ventilation with volume guarantee versus synchronized intermittent mandatory ventilation in the weaning phase of very low-birth weight infants with respiratory distress syndrome .
-METHODS	Randomized controlled prospective study .
-METHODS	Tertiary care neonatal unit .
-METHODS	A total of 60 premature infants who were less than 33 weeks ' gestation and/or less than 1,500 g birth weight and received mechanical ventilation because of respiratory distress syndrome were studied .
-METHODS	All infants were ventilated from the time of admission with synchronized intermittent positive pressure ventilation mode after surfactant treatment for respiratory distress syndrome and then switched to pressure support ventilation with volume guarantee or synchronized intermittent mandatory ventilation mode in the weaning phase .
-METHODS	The ventilatory variables and neonatal outcomes were recorded in each group .
-RESULTS	The mean peak inflation pressure was higher in synchronized intermittent mandatory ventilation group ( p < 0.001 ) and the mean airway pressure was higher in pressure support ventilation with volume guarantee group ( p = 0.03 ) , whereas mean tidal volume and respiratory rates were similar in both groups .
-RESULTS	The prevalence of postextubation atelectasis was higher in synchronized intermittent mandatory ventilation group , but the difference was not statistically significant ( p = 0.08 ) .
-RESULTS	No differences were found in the prevalence of reintubation , patent ductus arteriosus , intraventricular hemorrhage , retinopathy of prematurity , bronchopulmonary dysplasia , and pneumothorax between the groups .
-CONCLUSIONS	Pressure support ventilation with volume guarantee mode may be a safe and feasible mode during the weaning phase of very low-birth weight infants on mechanical ventilation support for respiratory distress syndrome with respect to reducing the frequency of postextubation atelectasis and using less peak inflation pressure .
-
-###25115201
-OBJECTIVE	To describe the study design and methodology for the p-EVES study , a trial designed to determine the effectiveness , cost-effectiveness and acceptability of portable Electronic Vision Enhancement System ( p-EVES ) devices and conventional optical low vision aids ( LVAs ) for near tasks in people with low vision .
-METHODS	The p-EVES study is a prospective two-arm randomised cross-over trial to test the hypothesis that , in comparison to optical LVAs , p-EVES can be : used for longer duration ; used for a wider range of tasks than a single optical LVA and/or enable users to do tasks that they were not able to do with optical LVAs ; allow faster performance of instrumental activities of daily living ; and allow faster reading .
-METHODS	A total of 100 adult participants with visual impairment are currently being recruited from Manchester Royal Eye Hospital and randomised into either Group 1 ( receiving the two interventions A and B in the order AB ) , or Group 2 ( receiving the two interventions in the order BA ) .
-METHODS	Intervention A is a 2-month period with conventional optical LVAs and a p-EVES device , and intervention B is a 2-month period with conventional optical LVAs only .
-RESULTS	The study adopts a mixed methods approach encompassing a broad range of outcome measures .
-RESULTS	The results will be obtained from the following primary outcome measures : Manchester Low Vision Questionnaire , capturing device ` usage ' data ( which devices are used , number of times , for what purposes , and for how long ) and the MNRead test , measuring threshold print size , critical print size , and acuity reserve in addition to reading speed at high ( 90 % ) contrast .
-RESULTS	Results will also be obtained from a series of secondary outcome measures which include : assessment of timed instrumental activities of daily living and a ` near vision ' visual functioning questionnaire .
-RESULTS	A companion qualitative study will permit comparison of results on how , where , and under what circumstances , p-EVES devices and LVAs are used in daily life .
-RESULTS	A health economic evaluation will provide results on : the incremental cost-effectiveness of p-EVES compared to optical magnifiers ; cost-effectiveness ; and cost-utility .
-CONCLUSIONS	The evidence base in low vision rehabilitation is modest and further high quality clinical trials are required to inform decisions on healthcare provision .
-CONCLUSIONS	The p-EVES study findings are anticipated to contribute to this broader evidence requirement , with the methodological issues evident here being relevant to other trials within the field .
-
-###24529933
-OBJECTIVE	This study sought to determine the utilization and outcomes for radial access for percutaneous coronary intervention ( PCI ) for ST-segment elevation acute myocardial infarction ( STEMI ) in common practice .
-BACKGROUND	Radial access for PCI has been studied considerably , but mostly in clinical trials .
-METHODS	All patients undergoing PCI for STEMI in 2009 to 2010 in New York were studied to determine the frequency and the patient-level predictors of radial access .
-METHODS	Differences in in-hospital/30-day mortality between radial and femoral access were also studied .
-RESULTS	Radial access increased from 4.9 % in the first quarter of 2009 to 11.9 % in the last quarter of 2010 .
-RESULTS	Significant independent predictors were higher body surface area , non-Hispanic ethnicity , Caucasian race , stable hemodynamic state , ejection fraction < 30 % and 50 % onset of STEMI from 12to 23 h before the index procedure , and peripheral vascular disease .
-RESULTS	Mortality was not related to access site after adjustment for covariates ( for radial vs. femoral access , adjusted odds ratio : 0.86 , 95 % confidence interval : 0.59 to 1.25 ) , but the radial access site was trending toward lower mortality for the 9 hospitals that used it for more than 10 % of their patients ( adjusted odds ratio : 0.61 , 95 % confidence interval : 0.36 to 1.02 ) .
-CONCLUSIONS	The use of a radial access site for PCI in STEMI patients increased between 2009 and 2010 , but was still infrequent in 2010 , and was used for lower-risk STEMI patients .
-CONCLUSIONS	There was no significant difference in mortality by access site , but there was a trend toward a mortality advantage for patients with a radial access site among hospitals that used it relatively frequently .
-
-###24929235
-OBJECTIVE	A recent study compared the efficacy of tenofovir disoproxil fumarate ( TDF ) vs the combination of emtricitabine and TDF ( FTC/TDF ) in patients with lamivudine-resistant chronic hepatitis B who were treated for as long as 96 weeks .
-OBJECTIVE	We report findings from resistance analyses conducted for this study .
-METHODS	Two hundred eighty patients with chronic hepatitis B virus ( HBV ) infection and lamivudine resistance ( confirmed by INNO-LiPA Multi-DR ) were randomly assigned ( 1:1 ) to groups treated with TDF or FTC/TDF .
-METHODS	The HBV reverse transcriptase domain from the polymerase gene from all patients was sequenced at baseline and from 18 viremic patients at week 96 or early discontinuation .
-RESULTS	At screening for the efficacy study , 99 % of patients were found to have lamivudine resistance .
-RESULTS	Prior exposure to entecavir or entecavir resistance was observed in 12 % of patients , and 22 % of patients had been previously exposed to adefovir ; 1.8 % were resistant to adefovir .
-RESULTS	Only 18 patients ( 6.4 % ) qualified for sequence analysis , including 1 patient who experienced virologic breakthrough and 17 with persistent viremia .
-RESULTS	Six of these patients did not have any sequence changes from baseline in HBV reverse transcriptase ( 33 % ) , and sequence analysis could not be performed for 5 patients ( 28 % ) .
-RESULTS	In 2 patients who qualified for phenotypic analysis ( 1 given TDF and 1 given FTC/TDF ) , no resistance to TDF was observed .
-RESULTS	Neither previous treatment exposure nor resistance to entecavir or adefovir affected viral kinetics .
-RESULTS	However , the mean baseline level of HBV DNA was significantly higher in viremic patients than in patients with viral suppression by week 96 ( 7.28 log10 IU/mL vs 5.62 log10 IU/mL ; P = .0003 ) .
-CONCLUSIONS	No resistance to TDF was detected through 96 weeks of treatment in patients with lamivudine-resistant chronic hepatitis B. Prior treatment or resistance to entecavir or adefovir did not affect viral kinetics through 96 weeks .
-CONCLUSIONS	No additional benefit was observed with the addition of emtricitabine vs TDF monotherapy .
-CONCLUSIONS	ClinicalTrial.gov number : NCT00737568 .
-
-###24403284
-BACKGROUND	The impact of educational strategies in the management of adverse treatment effects and drug interactions in adult patients with epilepsy with comorbidities remains undetermined .
-OBJECTIVE	The EDU-COM study is a randomised , pragmatic trial investigating the effect of a patient-tailored educational plan in patients with epilepsy with comorbidity .
-METHODS	174 adult patients with epilepsy with chronic comorbidities , multiple-drug therapy and reporting at least one adverse treatment effect and/or drug interaction at study entry were randomly assigned to the educational plan or usual care .
-METHODS	The primary endpoint was the number of patients becoming free from adverse treatment events and/or drug interactions after a 6-month follow-up .
-METHODS	The number of adverse treatment events and drug interactions , health-related quality of life ( HRQOL ) summary score changes and the monetary costs of medical contacts and drugs were assessed as secondary outcomes .
-RESULTS	The primary endpoint was met by 44.0 % of patients receiving the educational plan versus 28.9 % of those on usual care ( p = 0.0399 ) .
-RESULTS	The control group reported a significantly higher risk not to meet successfully the primary endpoint at the end of the study : OR ( 95 % CI ) of 2.29 ( 1.03 to 5.09 ) .
-RESULTS	A separate analysis on drug adverse effects and drug interactions showed that the latter were more sensitive to the effect of educational treatment .
-RESULTS	Quality of life and costs were not significantly different in the two groups .
-CONCLUSIONS	A patient-tailored educational strategy is effective in reducing drug-related problems ( particularly drug interactions ) in epilepsy patients with chronic comorbidities , without adding significant monetary costs .
-CONCLUSIONS	Registered at ClinicalTrials.gov , identifier NCT01804322 , ( http://www.clinicaltrials.gov ) .
-
-###25394949
-BACKGROUND	An emerging field of research describes the role of preoperative health behaviours , known as prehabilitation .
-BACKGROUND	The preoperative period may be a more physically and emotionally salient time to introduce and foster chronic adherence to health behaviours , such as exercise , in patients compared to post-treatment during recovery .
-BACKGROUND	Moreover , physical and psychosocial improvements during the preoperative period may translate into an enhanced recovery trajectory with reduced operative complications and postoperative adverse effects .
-BACKGROUND	No studies have assessed prehabilitation for men with prostate cancer undergoing radical prostatectomy .
-METHODS	This is a multi-centre , pilot randomized control trial conducted at two Canadian urban teaching hospitals .
-METHODS	100 men undergoing radical prostatectomy for prostate cancer with no contraindications to exercise will be recruited and randomized to the prehabiliation program or usual care .
-METHODS	Prehabilitation participants will engage in a preoperative , individualized exercise program including pelvic floor muscle strengthening instructions and a healthy lifestyle guide for men with prostate cancer .
-METHODS	These participants will be asked to engage in 60 minutes of home-based , unsupervised , moderate-intensity exercise on 3-4 days per week .
-METHODS	Usual care participants will receive the same pelvic floor muscle strengthening instructions and healthy lifestyle guide only .
-METHODS	We will assess the feasibility of conducting an adequately powered trial of the same design via recruitment rate , programmatic adherence/contamination , attrition , and safety .
-METHODS	Estimates of intervention efficacy will be captured through measurements at baseline ( 4-8 weeks preoperatively ) , within 1 week prior to surgery , and postoperatively at 4 , 12 , and 26 weeks .
-METHODS	Efficacy outcomes include : fatigue , quality of life , urinary incontinence , physical fitness , body composition , aerobic fitness , pain , and physical activity volume .
-CONCLUSIONS	The primary outcome of this study is to determine the feasibility of conducting a full-scale , randomized controlled trial of prehabilitation versus usual care and to estimate effect sizes that will inform sample size determinations for subsequent trials in this field .
-CONCLUSIONS	To our knowledge , this is the first study to examine a structured presurgical exercise program for men undergoing radical prostatectomy for prostate cancer .
-CONCLUSIONS	This trial will advance our understanding of strategies to efficiently and effectively use the preoperative period to optimize postoperative recovery .
-BACKGROUND	Clinicaltrials.gov Identifier : NCT02036684 .
-
-###25419179
-BACKGROUND	Diabetes mellitus ( DM ) is associated with poor outcome after surgery .
-BACKGROUND	The prevalence of DM in hospitalised patients is up to 40 % , meaning that the anaesthesiologist will encounter a patient with DM in the operating room on a daily basis .
-BACKGROUND	Despite an abundance of published glucose lowering protocols and the known negative outcomes associated with perioperative hyperglycaemia in DM , there is no evidence regarding the optimal intraoperative glucose lowering treatment .
-BACKGROUND	In addition , protocol adherence is usually low and protocol targets are not simply met .
-BACKGROUND	Recently , incretins have been introduced to lower blood glucose .
-BACKGROUND	The main hormone of the incretin system is glucagon-like peptide-1 ( GLP-1 ) .
-BACKGROUND	GLP-1 increases insulin and decreases glucagon secretion in a glucose-dependent manner , resulting in glucose lowering action with a low incidence of hypoglycaemia .
-BACKGROUND	We set out to determine the optimal intraoperative treatment algorithm to lower glucose in patients with DM type 2 undergoing non-cardiac surgery , comparing intraoperative glucose-insulin-potassium infusion ( GIK ) , insulin bolus regimen ( BR ) and GPL-1 ( liragludite , LG ) treatment .
-METHODS	This is a multicentre randomised open label trial in patients with DM type 2 undergoing non-cardiac surgery .
-METHODS	Patients are randomly assigned to one of three study arms ; intraoperative glucose-insulin-potassium infusion ( GIK ) , intraoperative sliding-scale insulin boluses ( BR ) or GPL-1 pre-treatment with liraglutide ( LG ) .
-METHODS	Capillary glucose will be measured every hour .
-METHODS	If necessary , in all study arms glucose will be adjusted with an intravenous bolus of insulin .
-METHODS	Researchers , care givers and patients will not be blinded for the assigned treatment .
-METHODS	The main outcome measure is the difference in median glucose between the three study arms at 1 hour postoperatively .
-METHODS	We will include 315 patients , which gives us a 90 % power to detect a 1 mmol l ( -1 ) difference in glucose between the study arms .
-CONCLUSIONS	The PILGRIM trial started in January 2014 and will provide relevant information on the perioperative use of GLP-1 agonists and the optimal intraoperative treatment algorithm in patients with diabetes mellitus type 2 .
-BACKGROUND	ClinicalTrials.gov , NCT02036372 .
-
-###24321403
-OBJECTIVE	Pharmacologic treatment for secondary prevention of coronary heart disease ( CHD ) is critical to prevent adverse clinical outcomes .
-OBJECTIVE	In a randomized controlled trial , we compared antiplatelet and statin adherence among patients with CHD who received : ( 1 ) text messages ( TM ) for medication reminders and education , ( 2 ) educational TM only , or ( 3 ) No TM .
-METHODS	A mobile health intervention delivered customized TM for 30 days .
-METHODS	We assessed and analyzed medication adherence with electronic monitoring devices [ Medication Event Monitoring System ( MEMS ) ] by one-way ANOVA and Welch tests , two-way TM response rates by t-tests , and self-reported adherence ( Morisky Medication Adherence Scale ) by Repeated Measures ANOVA .
-RESULTS	Among 90 patients ( 76 % male , mean age 59.2 years ) , MEMS revealed patients who received TM for antiplatelets had a higher percentage of correct doses taken ( p = 0.02 ) , percentage number of doses taken ( p = 0.01 ) , and percentage of prescribed doses taken on schedule ( p = 0.01 ) .
-RESULTS	TM response rates were higher for antiplatelets than statins ( p = 0.005 ) .
-RESULTS	Self-reported adherence revealed no significant differences among groups .
-CONCLUSIONS	TM increased adherence to antiplatelet therapy demonstrated by MEMS and TM responses .
-CONCLUSIONS	Feasibility and high satisfaction were established .
-CONCLUSIONS	Mobile health interventions show promise in promoting medication adherence .
-
-###26521574
-OBJECTIVE	To study the impacts of electroacupuncture ( EA ) on memory impairment after cerebral infarction through the observation of hydrogen proton magnetic resonance spectroscopy ( 1H-MRS ) of brain tissue metabolites in the patients of cerebral infarction .
-METHODS	Sixty cases of memory impairment after cerebral infarction were randomized into an observation group and a control group , 30 cases in each one .
-METHODS	The conventional rehabilitation training and medication were applied to all the patients .
-METHODS	In the observation group , beside the basic treatment , EA was applied to bilateral Ezhongxian ( MS 1 ) , Dingzhongxian ( MS 5 ) , Dingniehouxiexian ( MS 7 ) , Hegu ( LI 4 ) , Taichong ( LR 3 ) , Zusanli ( ST 36 ) , Taixi ( KI 3 ) , Xuanzhong ( GB 39 ) and Fengchi ( GB 20 ) .
-METHODS	The treatment was given once a day , 5 times a week , for 8 weeks .
-METHODS	The clinical memory scale was used for the score evaluation before and after treatment in all the patients .
-METHODS	The magnetic resonance image ( MRI ) and 1H-MRS scanning were applied to the head .
-METHODS	The ratio of N-acetyl aspartate ( NAA ) and creatine ( Cr ) and the ratio of choline ( Cho ) and Cr were determined in the foci of cerebral infarction .
-RESULTS	Eight weeks later , the scores of clinical memory scale were all increased after treatment as compared with those before treatment in the two group ( all P < 0.01 ) .
-RESULTS	The ratio of NAA and Cr was increased as compared with that before treatment ( P < 0.05 ) ; the ratio of Cho and Cr was reduced as compared with that before treatment ( P < 0.05 ) .
-RESULTS	The changes in the observation group were more obvious than those in the control group ( all P < 0.05 ) .
-CONCLUSIONS	On the basis of the conventional medication and rehabilitation training , EA improves the metabolism of brain tissue and memory function of the patients .
-CONCLUSIONS	The efficacy of this therapy is better than that of medication combined with rehabilitation training .
-
-###24772594
-BACKGROUND	Vasovagal syncope ( VVS ) represents by far the most common cause of syncope as it is diagnosed in around 50 % of all patients that come to an emergency department .
-BACKGROUND	Although VVS is not fatal , it can cause an injury .
-BACKGROUND	Even serious injuries are not common , but there are reports of serious injuries of up to 5 % .
-BACKGROUND	There are no current studies that demonstrate the effectiveness of any treatment .
-BACKGROUND	Past studies found that an Anti-Gravity suit ( G-suit ) can increase blood pressure and has been reported to prevent orthostatic hypotension effectively in patients with diabetes .
-BACKGROUND	It is possible that the G-suit can prevent VVS .
-OBJECTIVE	In the present study , the authors assessed the efficacy of G-suit for vasovagal syncope prevention .
-METHODS	In this open-label , randomized controlled study , we used the Italian tilt protocol , namely 60 degree passive tilting followed by 0.4 mg nitroglycerin challenge when the passive phase fails to induce syncope .
-METHODS	If test was positive , then patient was enrolled .
-METHODS	Tilt table test was repeated to compare G-suited and no G-suited to assess efficacy of G-suit for vasovagal syncope prevention .
-RESULTS	10 patients were enrolled .
-RESULTS	There is no difference between the control group and an experimental group .
-RESULTS	In this study there is no cardio-inhibition vasovagal syncope .
-RESULTS	Positive tilt table test occurred in 50 % of the patients receiving G-suited and 100 % in control group ( p 0.133 ) .
-CONCLUSIONS	G-suit is unable to prevent syncope in patients with positive tilt table test but the result is not statistically significant .
-CONCLUSIONS	However , the number of patients may be too small .
-
-###25597463
-BACKGROUND	Hearing-impaired listeners localize sounds better unaided than aided .
-BACKGROUND	Wide dynamic range compression circuits operating independently at each ear in bilateral fittings , and microphone positions of different hearing aid styles , have been cited as a reason .
-BACKGROUND	Two hearing aid features , inter-ear coordinated compression ( IE ) and pinna compensation ( PC ) , were developed to mitigate the compromised aided localization performance .
-OBJECTIVE	This study examined the effect of IE and PC on aided localization performance in the horizontal plane with hearing-impaired listeners .
-METHODS	A single-blind , repeated-measures design was used .
-METHODS	A total of 10 experienced hearing aid users with bilaterally symmetrical sensorineural hearing loss who had previously participated in localization training were evaluated .
-METHODS	Localization performance was measured using 12 loudspeakers spaced 30 apart on the horizontal plane .
-METHODS	Aided performance was evaluated using a behind-the-ear hearing aid at four settings : omnidirectional microphone ( Omni ) , Omni microphone with the PC feature , Omni microphone with IE , and Omni microphone with the PC feature and IE together .
-METHODS	In addition , unaided localization performance was measured .
-RESULTS	Significant improvement in the localization accuracy was measured for sounds arriving from the back when comparing the PC with the Omni conditions .
-RESULTS	The use of IE reduced the magnitude of errors for some listeners for sounds originating from 90 .
-RESULTS	The average reduction in the errors was 7.3 .
-CONCLUSIONS	This study confirmed that the use of the PC feature improved localization for sounds arriving from behind the listener .
-CONCLUSIONS	The use of IE may improve localization for some listeners for sounds arriving from the sides .
-
-###25486677
-BACKGROUND	On the Internet , people share personal experiences as well as facts and objective information .
-BACKGROUND	This also holds true for the exchange of health-related information in a variety of Internet forums .
-BACKGROUND	In online discussions about health topics , both fact-oriented and strongly personal contributions occur on a regular basis .
-OBJECTIVE	In this field experiment , we examined in what way the particular type of contribution ( ie , factual information vs personal experiences ) has an impact on the subsequent communication in health-related Internet forums .
-METHODS	For this purpose , we posted parallelized queries to 28 comparable Internet forums ; queries were identical with regard to the information contained but included either fact-oriented descriptions or personal experiences related to measles vaccination .
-METHODS	In the factual information condition , we posted queries to the forums that contained the neutral summary of a scientific article .
-METHODS	In the personal experiences condition , we posted queries to the forums that contained the same information as in the first condition , but were framed as personal experiences
-RESULTS	We found no evidence that personal experiences evoked more responses ( mean 3.79 , SD 3.91 ) from other members of the Internet forums than fact-oriented contributions ( mean 2.14 , SD 2.93 , t26 = 0.126 , P = .219 ) .
-RESULTS	But personal experiences elicited emotional replies ( mean 3.17 , SD 1.29 ) from other users to a greater extent than fact-oriented contributions ( mean 2.13 , SD 1.29 , t81 = 3.659 , P < .001 ) .
-CONCLUSIONS	We suggest that personal experiences elicited more emotional replies due to the process of emotional anchoring of people 's own style of communication .
-CONCLUSIONS	We recommend future studies should aim at testing the hypotheses with more general and with less emotionally charged topics , constructing different fact-oriented posts , and examining additional potential factors of influence such as personality factors or particular communication situations .
-
-###25524261
-OBJECTIVE	To test the hypothesis that trained nurse endoscopists are not inferior to medical endoscopists in finding adenomas during colonoscopy .
-METHODS	This is a prospective , randomised , single-blind , non-inferiority study comparing nurses with medical endoscopists in performing screening colonoscopy .
-METHODS	The nurse endoscopists had been trained according to the British Joint Advisory Group on GI Endoscopy curriculum and had completed at least 140 colonoscopic procedures prior to the study .
-METHODS	The primary endpoint was the adenoma detection rate .
-METHODS	Secondary endpoints included the caecal intubation rate , intubation time , complication rate , patient pain and satisfaction scores .
-RESULTS	We enrolled and analysed a total of 731 patients over a 15-month period .
-RESULTS	At least one adenoma was found in 159 ( 43.8 % ) of 363 patients by nurse endoscopists and 120 ( 32.7 % ) of 367 patients by medical endoscopists and a proportion difference of +11.1 % compared with the medical endoscopists ( 95 % CI 4.1 % to 18.1 % ) .
-RESULTS	The withdrawal time was , however , significantly longer among nurses ( 998 vs 575 s , p < 0.001 ) .
-RESULTS	After adjusting for differences in a regression analysis , colonoscopy by nurses was associated with a lower adenoma detection rate ( OR 0.475 : 95 % CI 0.311 to 0.725 ) .
-RESULTS	Nurse endoscopists had a lower caecal intubation rate ( 97.3 % vs 100 % ) , received better pain and satisfaction scores and had a high rate of patient acceptance .
-CONCLUSIONS	In this pragmatic trial , nurses can perform screening colonoscopy but require a longer procedural time to achieve a comparable adenoma detection rate as medical endoscopists .
-BACKGROUND	NCT01923155 .
-
-###25090173
-OBJECTIVE	Buprenorphine opioid agonist treatment ( OAT ) has established efficacy for treating opioid dependency among persons seeking addiction treatment .
-OBJECTIVE	However , effectiveness for out-of-treatment , hospitalized patients is not known .
-OBJECTIVE	To determine whether buprenorphine administration during medical hospitalization and linkage to office-based buprenorphine OAT after discharge increase entry into office-based OAT , increase sustained engagement in OAT , and decrease illicit opioid use at 6 months after hospitalization .
-METHODS	From August 1 , 2009 , through October 31 , 2012 , a total of 663 hospitalized , opioid-dependent patients in a general medical hospital were identified .
-METHODS	Of these , 369 did not meet eligibility criteria .
-METHODS	A total of 145 eligible patients consented to participation in the randomized clinical trial .
-METHODS	Of these , 139 completed the baseline interview and were assigned to the detoxification ( n = 67 ) or linkage ( n = 72 ) group .
-METHODS	Five-day buprenorphine detoxification protocol or buprenorphine induction , intrahospital dose stabilization , and postdischarge transition to maintenance buprenorphine OAT affiliated with the hospital 's primary care clinic ( linkage ) .
-METHODS	Entry and sustained engagement with buprenorphine OAT at 1 , 3 , and 6 months ( medical record verified ) and prior 30-day use of illicit opioids ( self-report ) .
-RESULTS	During follow-up , linkage participants were more likely to enter buprenorphine OAT than those in the detoxification group ( 52 [ 72.2 % ] vs 8 [ 11.9 % ] , P < .001 ) .
-RESULTS	At 6 months , 12 linkage participants ( 16.7 % ) and 2 detoxification participants ( 3.0 % ) were receiving buprenorphine OAT ( P = .007 ) .
-RESULTS	Compared with those in the detoxification group , participants randomized to the linkage group reported less illicit opioid use in the 30 days before the 6-month interview ( incidence rate ratio ,0.60 ; 95 % CI , 0.46-0 .73 ; P < .01 ) in an intent-to-treat analysis .
-CONCLUSIONS	Compared with an inpatient detoxification protocol , initiation of and linkage to buprenorphine treatment is an effective means for engaging medically hospitalized patients who are not seeking addiction treatment and reduces illicit opioid use 6 months after hospitalization .
-CONCLUSIONS	However , maintaining engagement in treatment remains a challenge .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00987961 .
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-###24977321
-OBJECTIVE	Ureteroscopy is central to the surgical management of ureteral stones .
-OBJECTIVE	Fluoroscopy is conventionally used for intraoperative guidance , although there is growing effort to decrease the exposure of patients and staff to ionizing radiation .
-OBJECTIVE	We developed a radiation-free approach to ureteroscopy using ultrasound guidance to manage ureteral stones .
-OBJECTIVE	To our knowledge we present the first randomized trial to study its safety and efficacy .
-METHODS	This single center , randomized clinical trial from 2011 to 2013 enlisted patients who presented with symptomatic ureteral stones 8 mm or less without a significant ipsilateral stone burden .
-METHODS	Patients were randomly assigned to ultrasound or fluoroscopic guided ureteroscopy after temporizing ureteral stent placement .
-METHODS	Intraoperative ultrasound guidance was performed using real-time imaging with the transducer placed at the patient flank to visualize the collecting system of the ipsilateral kidney .
-METHODS	We compared operative time , stone size , stone-free status and complication rates between the 2 groups .
-RESULTS	A total of 50 patients were enrolled in study with 25 per arm .
-RESULTS	There was no difference in stone size ( 5.9 vs 5.7 mm ) , patient age ( 56 vs 52 years ) or body mass index ( 31 vs 30 kg/m ( 2 ) ) in the test group compared to controls .
-RESULTS	The ultrasound guidance cohort showed no significant difference in the stone-free rate ( 86 % vs 86 % ) or the complication rate ( 8 % vs 16 % ) compared to controls .
-RESULTS	Operative time was no longer in the ultrasound guidance cohort .
-CONCLUSIONS	In this feasibility study we found that ureteral stones may be definitively managed in a timely , effective and safe fashion without ionizing radiation in the general population using this novel technique of ultrasound guided ureteroscopy .
-
-###26035255
-BACKGROUND	Elotuzumab , an immunostimulatory monoclonal antibody targeting signaling lymphocytic activation molecule F7 ( SLAMF7 ) , showed activity in combination with lenalidomide and dexamethasone in a phase 1b-2 study in patients with relapsed or refractory multiple myeloma .
-METHODS	In this phase 3 study , we randomly assigned patients to receive either elotuzumab plus lenalidomide and dexamethasone ( elotuzumab group ) or lenalidomide and dexamethasone alone ( control group ) .
-METHODS	Coprimary end points were progression-free survival and the overall response rate .
-METHODS	Final results for the coprimary end points are reported on the basis of a planned interim analysis of progression-free survival .
-RESULTS	Overall , 321 patients were assigned to the elotuzumab group and 325 to the control group .
-RESULTS	After a median follow-up of 24.5 months , the rate of progression-free survival at 1 year in the elotuzumab group was 68 % , as compared with 57 % in the control group ; at 2 years , the rates were 41 % and 27 % , respectively .
-RESULTS	Median progression-free survival in the elotuzumab group was 19.4 months , versus 14.9 months in the control group ( hazard ratio for progression or death in the elotuzumab group , 0.70 ; 95 % confidence interval , 0.57 to 0.85 ; P < 0.001 ) .
-RESULTS	The overall response rate in the elotuzumab group was 79 % , versus 66 % in the control group ( P < 0.001 ) .
-RESULTS	Common grade 3 or 4 adverse events in the two groups were lymphocytopenia , neutropenia , fatigue , and pneumonia .
-RESULTS	Infusion reactions occurred in 33 patients ( 10 % ) in the elotuzumab group and were grade 1 or 2 in 29 patients .
-CONCLUSIONS	Patients with relapsed or refractory multiple myeloma who received a combination of elotuzumab , lenalidomide , and dexamethasone had a significant relative reduction of 30 % in the risk of disease progression or death .
-CONCLUSIONS	( Funded by Bristol-Myers Squibb and AbbVie Biotherapeutics ; ELOQUENT-2 ClinicalTrials.gov number , NCT01239797 . )
-
-###24669841
-BACKGROUND	Invasive fungal infections are very severe infections associated with high mortality rates , despite the availability of new classes of antifungal agents .
-BACKGROUND	Based on pathophysiological mechanisms and limited pre-clinical and clinical data , adjunctive immune-stimulatory therapy with interferon-gamma ( IFN - ) may represent a promising candidate to improve outcome of invasive fungal infections by enhancing host defence mechanisms .
-METHODS	In this open-label , prospective case series , we describe eight patients with invasive Candida and/or Aspergillus infections who were treated with recombinant IFN - ( rIFN - , 100 g s.c. , thrice a week ) for 2 weeks in addition to standard antifungal therapy .
-RESULTS	Recombinant IFN - treatment in patients with invasive Candida and/or Aspergillus infections partially restored immune function , as characterized by an increased HLA-DR expression in those patients with a baseline expression below 50 % , and an enhanced capacity of leukocytes from treated patients to produce proinflammatory cytokines involved in antifungal defence .
-CONCLUSIONS	The present study provides evidence that adjunctive immunotherapy with IFN - can restore immune function in fungal sepsis patients , warranting future clinical studies to assess its potential clinical benefit .
-BACKGROUND	ClinicalTrials.gov -- NCT01270490 .
-
-###25293818
-OBJECTIVE	To assess the feasibility of using an ultra-low dose ( 0.05 mmol/kg of body weight [ BW ] ) of high relaxivity contrast agent for late gadolinium enhancement ( LGE ) imaging in patients with acute myocardial infarction ( AMI ) .
-METHODS	17 consecutive patients ( mean age , 60.1 10.3 years ) with ST-segment elevation AMI underwent two randomized cardiac magnetic resonance studies ( exam intervals between 24 and 48h ) on a 1.5 T unit during the first week after the event using gadobenate dimeglumine ( Gd-BOPTA ) at the dose of 0.1 mmol/kg BW ( standard dose or SD group ) and 0.05 mmol/kg BW ( half dose or HD group ) .
-METHODS	Image quality was qualitatively assessed .
-METHODS	Quantitative analysis of LGE were performed by measuring signal intensity ( SI ) , signal-to-noise ratio ( SNR ) in the infarcted myocardium ( IM ) , non-infarcted myocardium ( N-IM ) and left ventricular cavity ( LVC ) in images acquired at 1 , 3 , 5 , 10 , 15 and 20 min after administration of Gd-BOPTA using both contrast media protocol .
-METHODS	Contrast-to-noise ratio ( CNR ) between IM and N-IM ( CNR IM/N-IM ) and between IM and LVC ( CNR IM/LVC ) were also quantified for each time point .
-METHODS	Moreover the extent of infarcted myocardium was measured .
-RESULTS	102 LGE images were evaluated for each dose group .
-RESULTS	Quality score was significantly higher for SD at 1 , 15 and 20 min ( 0.002 < p < 0.046 ) and for HD at 5 min ( p = 0.013 ) .
-RESULTS	SNR has been higher in the SD group compared to the HD group even though not statistically significant at any time-point for both IM ( SD vs. HD : 87.7 73 vs. 65 66 ; 0.15 < p < 0.38 ) and N-IM ( SD vs. HD : 22 61 vs. 9.9 6.5 ; 0.09 < p < 0.43 ) .
-RESULTS	LVC SNR was significantly higher with SD at 10 min ( p = 0.03 ) , 15 min ( p = 0.001 ) and 20 min ( p = 0.004 ) .
-RESULTS	CNR between the IM and N-IM was significantly higher using SD compared to HD ( 1382.24 1049 vs. 695.4 500 ; 0.000 < p < 0.028 ) at 10 , 15 and 20 min .
-RESULTS	No significant differences in CNR IM/LVC were noted for HD acquired 5 min after CM administration compared to SD acquired at 10 ( p = 0.34 ) , 15 ( p = 0.96 ) and 20 ( p = 0.41 ) min , and between HD at 10 min compared to SD acquired at 15 min ( p = 0.78 ) and 20 min ( p = 0.32 ) .
-RESULTS	Good correlation between SD and HD ( 0.56 < r ( 2 ) < 0.85 , p < 0.024 ) was found at all time-points in the measuring of IA .
-CONCLUSIONS	The use of a 0.05 mmol/kg dose of gadobenate dimeglumine is feasible for LGE imaging of acute MI and the best image quality is obtained at 5 min after contrast administration .
-CONCLUSIONS	It could be beneficial in patient with renal failure and a solution to improve the identification of subendocardial infarction reducing examination time , costs and total gadolinium load .
-CONCLUSIONS	However , the standard dose of 0.1 mmol/kg provides overall better image quality , with the best performance obtained at the delay of 10 min or more after Gd-BOPTA administration , and it should be routinely preferred .
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-###25238699
-OBJECTIVE	To evaluate the effects of olive oil and flaxseed oil compared with mineral oil for the treatment of constipation in patients undergoing hemodialysis .
-METHODS	A 4-week , double-blind , randomized , and controlled trial was conducted .
-METHODS	Fifty constipated patients ( 29 % male , 5112years ) diagnosed by the Rome III criteria were randomly assigned to receive mineral oil ( control group ; n = 17 ) , olive oil ( n = 16 ) , or flaxseed oil ( n = 17 ) .
-METHODS	The initial oil dose was 4mL/day , and adjustments during the follow-up could be made as needed .
-METHODS	The impact of the intervention was assessed by the Rome III criteria scores .
-RESULTS	The most frequent symptoms of constipation evaluated by the Roma III criteria at baseline were comparable among the groups and included `` incomplete evacuation '' ( 92 % ) , `` lumpy or hard stools , '' ( 72 % ) and `` anorectal obstruction '' ( 70 % ) .
-RESULTS	The Rome III score improved significantly in patients receiving mineral oil ( 10.55.0 to 4.14.0 ; P < .01 ) , olive oil ( 10.34.2 to 3.23.8 ; P = .01 ) , and flaxseed oil ( 9.64.2 to 6.05.1 ; P < .01 ) , with no significant group-by-time interaction ( P = .15 ) .
-RESULTS	The scores of 5 from 6 constipation symptoms reduced similarly in the mineral oil and olive oil groups , whereas only the frequency of evacuation and the consistency of stools improved in the flaxseed oil group .
-CONCLUSIONS	We demonstrated that the daily use of olive oil or flaxseed oil was as effective as mineral oil in the treatment of constipation in patients undergoing hemodialysis .
-
-###24387594
-BACKGROUND	The growing prevalence of health care ethics consultation ( HCEC ) services in the U.S. has been accompanied by an increase in calls for accountability and quality assurance , and for the debates surrounding why and how HCEC is evaluated .
-BACKGROUND	The objective of this study was to evaluate the effectiveness of HCEC as indicated by several novel outcome measurements in East Asian medical encounters .
-METHODS	Patients with medical uncertainty or conflict regarding value-laden issues , and requests made by the attending physicians or nurses for HCEC from December 1 , 2009 to April 30 , 2012 were randomly assigned to the usual care group ( UC group ) and the intervention group ( HCEC group ) .
-METHODS	The patients in the HCEC group received HCEC conducted by an individual ethics consultant .
-METHODS	Data analysis was based on the intention-to-treat principle .
-METHODS	Mann-Whitney test and Chi-squared test were used depending on the scale of measurement .
-RESULTS	Thirty-three patients ( 53.23 % ) were randomly assigned to the HCEC group and 29 patients were randomly assigned to the UC group .
-RESULTS	Among the 33 patients in the HCEC group , two ( 6.06 % ) of them ultimately did not receive a HCEC service .
-RESULTS	Among the 29 patients in the UC group , four ( 13.79 % ) of them received a HCEC service .
-RESULTS	The survival rate at hospital discharge did not differ between the two groups .
-RESULTS	Patients in the HCEC group showed significant reductions in the entire ICU stay and entire hospital stay .
-RESULTS	HCEC significantly facilitated achieving the goal of medical care ( p < .01 ) .
-RESULTS	Furthermore , patients in the HCEC group had a shorter ICU stay and shorter hospital stay after the occurrence of medical uncertainty or conflict regarding value-laden issues than those in the UC group .
-CONCLUSIONS	Our findings demonstrated that HCEC were associated with reduced consumption of medical resources as indicated by shorter entire ICU stay , entire hospital stay , and shorter ICU and hospital stay after the occurrence of the medical uncertainty or conflict regarding value-laden issues .
-CONCLUSIONS	This study also showed that HCEC facilitated achieving a consensus regarding the goal of medical care , which conforms to the goal of HCEC .
-
-###24923656
-BACKGROUND	The methods of evaluating endoscopic mucosal findings and the definition of mucosal healing in inflammatory bowel disease have not been standardized .
-OBJECTIVE	To examine a third-party central review of colonic mucosal evaluations .
-METHODS	A double-blind , placebo-controlled , parallel-group trial was performed for 4weeks , which involved continuous administration of a 1-g mesalazine suppository to 129 patients with mild to moderate ulcerative colitis and active rectal inflammatory findings .
-METHODS	Mucosal findings were evaluated by using a 4-grade score ( 0 , 1 , 2 , 3 ) .
-METHODS	Reviews by attending physicians were considered the primary evaluations .
-METHODS	Concurrently , a central review committee of 7 gastroenterologists served as the third party .
-RESULTS	The endoscopic remission induction rate from the attending physicians ' evaluations was 82.8 % in the mesalazine suppository group and 31.1 % in the placebo suppository group , whereas the respective rates from the central review committee were 90.6 % and 59.0 % .
-RESULTS	However , there was a difference of 27.9 percentage points between the remission induction rates of the placebo group found by the two groups of raters .
-RESULTS	Differences in the evaluations of mucosal finding scores were also found among the third-party reviewers .
-CONCLUSIONS	The evaluations of the attending physicians were consistent with those of the central review committee in showing the effectiveness of mesalazine suppository through the index of mucosal healing .
-CONCLUSIONS	However , differences were observed among the raters in their evaluations of mucosal finding scores .
-CONCLUSIONS	Therefore , standardizing evaluation criteria and improving review methods for mucosal findings would enable the more effective use of third-party central reviews in clinical drug trials .
-
-###25071111
-OBJECTIVE	Poor and underserved women face barriers in receiving timely and appropriate breast cancer care .
-OBJECTIVE	Patient navigators help individuals overcome these barriers , but little is known about whether patient navigation improves quality of care .
-OBJECTIVE	The purpose of this study is to examine whether navigated women with breast cancer are more likely to receive recommended standard breast cancer care .
-METHODS	Women with breast cancer who participated in the national Patient Navigation Research Program were examined to determine whether the care they received included the following : initiation of antiestrogen therapy in patients with hormone receptor-positive breast cancer ; initiation of postlumpectomy radiation therapy ; and initiation of chemotherapy in women younger than age 70 years with triple-negative tumors more than 1 cm .
-METHODS	This is a secondary analysis of a multicenter quasi-experimental study funded by the National Cancer Institute to evaluate patient navigation .
-METHODS	Multiple logistic regression was performed to compare differences in receipt of care between navigated and non-navigated participants .
-RESULTS	Among participants eligible for antiestrogen therapy , navigated participants ( n = 380 ) had a statistically significant higher likelihood of receiving antiestrogen therapy compared with non-navigated controls ( n = 381 ; odds ratio [ OR ] , 1.73 ; P = .004 ) in a multivariable analysis .
-RESULTS	Among the participants eligible for radiation therapy after lumpectomy , navigated participants ( n = 255 ) were no more likely to receive radiation ( OR , 1.42 ; P = .22 ) than control participants ( n = 297 ) .
-CONCLUSIONS	We demonstrate that navigated participants were more likely than non-navigated participants to receive antiestrogen therapy .
-CONCLUSIONS	Future studies are required to determine the full impact patient navigation may have on ensuring that vulnerable populations receive quality care .
-
-###25742476
-BACKGROUND	Chemoradioimmunotherapy of patients with pancreatic adenocarcinoma from the CapRI trial did not show any benefit of interferon - in addition to a 5-fluorouracil ( 5FU ) - based treatment .
-BACKGROUND	The aim of this study was to identify immunological parameters in patients from this trial to be used for predictive and/or prognostic purposes .
-METHODS	The following methods were used : tumour immunohistology , FACS analyses , cytokine measurement , as well as cytotoxicity and ELIspot .
-METHODS	Immunological parameters were correlated with patients ' survival using the Kaplan-Meier method .
-RESULTS	Irrespective of therapy type , high lymphocyte accumulation in tumours and frequencies of NK cells and effector ( eff ) CD8 ( + ) T cells in peripheral blood of the patients were associated with patients ' survival .
-RESULTS	Amount of CD3 ( + ) and effector-memory CD8 ( + ) blood lymphocytes , expression of CD152 and interleukin ( IL ) -2 serum level showed a predictive value for chemoradioimmunotherapy .
-RESULTS	Tumoural accumulation of CD3 ( + ) and CD8 ( + ) cells was predictive for outcome of chemotherapy alone .
-RESULTS	Besides , we identified the frequencies of CD3 ( + ) lymphocytes , effCD8 ( + ) T cells and NK cells in the peripheral blood of the patients , and IL-10 amount in serum , to be predictive values for 5FU-based chemotherapy .
-CONCLUSIONS	Immunological parameters , identified in this trial as possible markers , may be of interest in personalized medicine towards the improvement of the treatment and prognosis of pancreatic carcinoma patients .
-
-###25024031
-BACKGROUND	Patient-specific instrumentation in TKA has the proposed benefits of improving coronal and sagittal alignment and rotation of the components .
-BACKGROUND	In contrast , the literature is inconsistent if the use of patient-specific instrumentation improves alignment in comparison to conventional instrumentation .
-BACKGROUND	Depending on the manufacturer , patient-specific instrumentation is based on either MRI or CT scans .
-BACKGROUND	However , it is unknown whether one patient-specific instrumentation approach is more accurate than the other and if there is a potential benefit in terms of reduction of duration of surgery .
-OBJECTIVE	We compared the accuracy of MRI - and CT-based patient-specific instrumentation with conventional instrumentation and with each other in TKAs .
-OBJECTIVE	The three approaches also were compared with respect to validated outcomes scores and duration of surgery .
-METHODS	A randomized clinical trial was conducted in which 90 patients were enrolled and divided into three groups : CT-based , MRI-based patient-specific instrumentation , and conventional instrumentation .
-METHODS	The groups were not different regarding age , male/female sex distribution , and BMI .
-METHODS	In all groups , coronal and sagittal alignments were measured on postoperative standing long-leg and lateral radiographs .
-METHODS	Component rotation was measured on CT scans .
-METHODS	Clinical outcomes ( Knee Society and WOMAC scores ) were evaluated preoperatively and at a mean of 3 months postoperatively and the duration of surgery was analyzed for each patient .
-METHODS	MRI - and CT-based patient-specific instrumentation groups were first compared with conventional instrumentation , the patient-specific instrumentation groups were compared with each other , and all three approaches were compared for clinical outcome measures and duration of surgery .
-RESULTS	Compared with conventional instrumentation MRI - and CT-based patient-specific instrumentation showed higher accuracy regarding the coronal limb axis ( MRI versus conventional , 1.0 [ range , 0-4 ] versus 4.5 [ range , 0-8 ] , p < 0.001 ; CT versus conventional , 3.0 [ range , 0-5 ] versus 4.5 [ range , 0-8 ] , p = 0.02 ) , femoral rotation ( MRI versus conventional , 1.0 [ range , 0-2 ] versus 4.0 [ range , 1-7 ] , p < 0.001 ; CT versus conventional , 1.0 [ range , 0-2 ] versus 4.0 [ range , 1-7 ] , p < 0.001 ) , and tibial slope ( MRI versus conventional , 1.0 [ range , 0-2 ] versus 3.5 [ range , 1-7 ] , p < 0.001 ; CT versus conventional , 1.0 [ range , 0-2 ] versus 3.5 [ range , 1-7 ] , p < 0.001 ) , but the differences were small .
-RESULTS	Furthermore , MRI-based patient-specific instrumentation showed a smaller deviation in the postoperative coronal mechanical limb axis compared with CT-based patient-specific instrumentation ( MRI versus CT , 1.0 [ range , 0-4 ] versus 3.0 [ range , 0-5 ] , p = 0.03 ) , while there was no difference in femoral rotation or tibial slope .
-RESULTS	Although there was a significant reduction of the duration of surgery in both patient-specific instrumentation groups in comparison to conventional instrumentation ( MRI versus conventional , 58 minutes [ range , 53-67 minutes ] versus 76 minutes [ range , 57-83 minutes ] , p < 0.001 ; CT versus conventional , 63 minutes [ range , 59-69 minutes ] versus 76 minutes [ range , 57-83 minutes ] , p < .001 ) , there were no differences in the postoperative Knee Society pain and function and WOMAC scores among the groups .
-CONCLUSIONS	Although this study supports that patient-specific instrumentation increased accuracy compared with conventional instrumentation and that MRI-based patient-specific instrumentation is more accurate compared with CT-based patient-specific instrumentation regarding coronal mechanical limb axis , differences are only subtle and of questionable clinical relevance .
-CONCLUSIONS	Because there are no differences in the long-term clinical outcome or survivorship yet available , the widespread use of this technique can not be recommended .
-
-###24491005
-OBJECTIVE	To determine whether Zinc supplementation could reduce relapse rate in children with nephrotic syndrome .
-METHODS	Randomized-controlled trial .
-METHODS	National Institute of Child-Health and The Kidney Centre , Karachi , from January 2008 to June 2009 .
-METHODS	Sixty nephrotic children aged 2 - 15 years were selected .
-METHODS	Baseline data including age , number of infections and relapses during pre and post study one year were recorded .
-METHODS	Randomization was done to divide into Zinc group ( Zg ) to receive Zinc versus placebo ( Pg ) for 6 months .
-METHODS	Relapses and infections were treated with standard therapy .
-METHODS	T-test and chi-square tests were used to compare the mean values and proportions respectively with significance at p < 0.05 .
-RESULTS	Among 60 children , 54 completed trial ( Zg = 25 , Pg = 29 ) .
-RESULTS	Forty ( 74 % ) were males and 14 ( 26 % ) females .
-RESULTS	Mean age , pre study relapses and Zinc level in the two groups were similar .
-RESULTS	Overall , infections and relapses were observed in 43 ( 79.62 % ) and 17 cases ( 31.48 % ) respectively .
-RESULTS	There was no significant difference in frequency of infections and mean infection rate in Zg ( 20 , 80 % and 1.92 1.47 ) compared to Pg ( 23 , 79.3 % and 2 1.53 , p = 0.950 ) .
-RESULTS	Relapses occurred in 7 ( 28 % ) in Zg compared to 10 ( 34 % ) in Pg which was not significant ( p = 0.609 ) .
-RESULTS	Mean infection and relapse rate per patient per year ( PPPY ) in Zg was 1.92 1.47 and 1.14 0.37 compared to 2 1.53 and1 .3 0.48 in Pg respectively ( p = 0.846 , 0.464 ) .
-RESULTS	Pre study relapses in two groups were similar ( Zg vs. Pg = 96 vs. 96.6 % ) whereas post study relapses in Zg were lower ( 7 , 28 % ) compared to Pg ( 10 , 34.5 % ) .
-RESULTS	Post study mean relapse rate in Zg was 1.14 0.37 PPPY compared to 2.71 1.11 in pre study ( p = 0.005 ) .
-RESULTS	In Pg , post study mean relapse rate PPPY was 1.30 0.48 compared to 1.70 0.48 in pre study period ( p = 0.037 ) .
-RESULTS	Relapse rate reduction was 43 % after Zinc supplementation compared to 27 % reduction in placebo .
-RESULTS	Metallic taste was observed in 10 % of cases .
-CONCLUSIONS	Zinc supplementation was helpful in reducing relapses in nephrotic syndrome .
-
-###24473958
-OBJECTIVE	To compare two systems of arterial catheters maintenance in postoperative pediatric surgery using intermittent or continuous infusion of heparin solution and to analyze adverse events related to the site of catheter insertion and the volume of infused heparin solution .
-METHODS	Randomized control trial with 140 patients selected for continuous infusion group ( CIG ) and intermittent infusion group ( IIG ) .
-METHODS	The variables analyzed were : type of heart disease , permanence time and size of the catheter , insertion site , technique used , volume of heparin solution and adverse events .
-METHODS	The descriptive variables were analyzed by Student 's t-test and the categorical variables , by chi-square test , being significant p < 0.05 .
-RESULTS	The median age was 11 ( 0-22 ) months , and 77 ( 55 % ) were females .
-RESULTS	No significant differences between studied variables were found , except for the volume used in CIG ( 12.01.2 mL/24 hours ) when compared to IIG ( 5.33.5 mL/24 hours ) with p < 0.0003 .
-CONCLUSIONS	The continuous infusion system and the intermittent infusion of heparin solution can be used for intra-arterial catheters maintenance in postoperative pediatric surgery , regardless of patient 's clinical and demographic characteristics .
-CONCLUSIONS	Adverse events up to the third postoperative day occurred similarly in both groups .
-CONCLUSIONS	However , the intermittent infusion system usage in underweight children should be considered , due to the lower volume of infused heparin solution [ ClinicalTrials.gov Identifier : NCT01097031 ] .
-
-###25149070
-OBJECTIVE	In the double-blind placebo-controlled Fenofibrate Intervention and Event Lowering in Diabetes trial ( n = 9,795 ) , fenofibrate reduced major cardiovascular events in type 2 diabetes .
-OBJECTIVE	Sex-related differences in fenofibrate response could be clinically relevant and were pre-specified analyses .
-METHODS	Women ( n = 3,657 ) and men ( n = 6,138 ) with type 2 diabetes not using statins were assigned fenofibrate ( 200mg/day ) or placebo for 5years .
-METHODS	Effects on lipoproteins and total cardiovascular events were evaluated by sex .
-RESULTS	Baseline total , LDL - , HDL - and non-HDL cholesterol and apolipoproteins A-I and B differed between sexes , and these and triacylglycerol levels improved with fenofibrate in both sexes ( all p < 0.001 ) .
-RESULTS	Fenofibrate reduced total , LDL - and non-HDL cholesterol and apolipoprotein B more in women ( all p < 0.001 ) , independent of menopausal status and statin uptake .
-RESULTS	Adjusted for covariates , fenofibrate reduced total cardiovascular outcomes ( cardiovascular death , fatal and non-fatal stroke and carotid and coronary revascularisation ) by 30 % in women ( 95 % CI 8 % , 46 % ; p = 0.008 ) and 13 % in men ( 95 % CI -1 % , 24 % ; p = 0.07 ) with no treatment-by-sex interaction ( p > 0.1 ) .
-RESULTS	In patients with high triacylglycerol levels and low HDL-cholesterol , fenofibrate reduced total cardiovascular outcomes by 30 % ( 95 % CI -7 % , 54 % ) in women and 24 % ( 95 % CI 2 % , 42 % ) in men , with no treatment-by-sex interaction ( p > 0.1 ) .
-CONCLUSIONS	Fenofibrate improved the lipoprotein profile more in women than men .
-CONCLUSIONS	Cardiovascular event reductions with fenofibrate were consistently similar in women and men , both overall and among those with low HDL-cholesterol and high triacylglycerol levels .
-CONCLUSIONS	These data provide reassurance about fenofibrate efficacy in women and men .
-CONCLUSIONS	Both sexes with type 2 diabetes should be considered for fenofibrate therapy for cardioprotection .
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-###24448512
-BACKGROUND	We aimed to determine with this randomized , triple-masked , placebo-controlled study if benefits are afforded by adding a multiple-day , ambulatory , continuous ropivacaine paravertebral nerve block to a single-injection ropivacaine paravertebral block after mastectomy .
-METHODS	Preoperatively , 60 subjects undergoing unilateral ( n = 24 ) or bilateral ( n = 36 ) mastectomy received either unilateral or bilateral paravertebral perineural catheter ( s ) , respectively , inserted between the third and fourth thoracic transverse process ( es ) .
-METHODS	All subjects received an initial bolus of ropivacaine 0.5 % ( 15 mL ) via the catheter ( s ) .
-METHODS	Subjects were randomized to receive either perineural ropivacaine 0.4 % or normal saline using portable infusion pump ( s ) [ 5 mL/h basal ; 300 mL reservoir ( s ) ] .
-METHODS	Subjects remained hospitalized for at least 1 night and were subsequently discharged home where the catheter ( s ) were removed on postoperative day ( POD ) 3 .
-METHODS	Subjects were contacted by telephone on PODs 1 , 4 , 8 , and 28 .
-METHODS	The primary end point was average pain ( scale , 0-10 ) queried on POD 1 .
-RESULTS	Average pain queried on POD 1 for subjects receiving perineural ropivacaine ( n = 30 ) was a median ( interquartile ) of 2 ( 0-3 ) , compared with 4 ( 1-5 ) for subjects receiving saline ( n = 30 ; 95 % confidence interval difference in medians , -4.0 to -0.3 ; P = 0.021 ] .
-RESULTS	During this same period , subjects receiving ropivacaine experienced a lower severity of breakthrough pain ( 5 [ 3-6 ] vs 7 [ 5-8 ] ; P = 0.046 ) as well .
-RESULTS	As a result , subjects receiving perineural ropivacaine experienced less pain-induced physical and emotional dysfunction , as measured with the Brief Pain Inventory ( lower score = less dysfunction ) : 14 ( 4-37 ) versus 57 ( 8-67 ) for subjects receiving perineural saline ( P = 0.012 ) .
-RESULTS	For the subscale that measures the degree of interference of pain on 7 domains , such as general activity and relationships , subjects receiving perineural saline reported a median score 10 times higher ( more dysfunction ) than those receiving ropivacaine ( 3 [ 0-24 ] vs 33 [ 0-44 ] ; P = 0.035 ) .
-RESULTS	In contrast , after infusion discontinuation , there were no statistically significant differences detected between treatment groups .
-CONCLUSIONS	After mastectomy , adding a multiple-day , ambulatory , continuous ropivacaine infusion to a single-injection ropivacaine paravertebral nerve block results in improved analgesia and less functional deficit during the infusion .
-CONCLUSIONS	However , no benefits were identified after infusion discontinuation .
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-###25085943
-OBJECTIVE	We hypothesised that short-term application of bi-level nasal continuous positive airway pressure CPAP ( SiPAP ) compared with conventional nasal CPAP ( nCPAP ) at the same mean airway pressure in infants with persistent oxygen need recovering from respiratory distress syndrome would improve CO2 removal with no change in oxygen requirement .
-METHODS	Non-blinded , randomised , observational four-period crossover study .
-METHODS	Level III NICU ; low-birthweight infants requiring CPAP and oxygen while recovering from respiratory distress syndrome .
-METHODS	Infants requiring nasal CPAP for > 24h prior to study enrolment , and fraction of inspired oxygen requirement ( FiO2 ) of 0.25-0 .5 , were randomised to either nCPAP or SiPAP .
-METHODS	A crossover design with four 1 h treatment periods was used such that each infant received both treatments twice .
-METHODS	Oxygen saturations ( SaO2 ) , transcutaneous CO2 ( tcCO2 ) and vital signs were monitored continuously .
-METHODS	Polysomnographic recordings were analysed for apnoea , bradycardia and oxygen desaturation .
-RESULTS	Twenty low-birthweight infants receiving 0.30.04 % supplemental oxygen on CPAP of 6 cm H2O were studied at an average of 33days of age ( 23days , SD ) .
-RESULTS	There were no differences in tcCO2 or other physiological parameters except mean blood pressure , which was lower during nCPAP ( 52.38.3 vs 54.49.1 mmHg ; SD ; p < 0.01 ) .
-RESULTS	No differences in short or prolonged apnoea , bradycardia or significant desaturation events were observed .
-CONCLUSIONS	At similar mean airway pressures , SiPAP does not improve CO2 removal , oxygenation or other studied physiological parameters with the exception of mean blood pressure , which was not clinically significant .
-BACKGROUND	NCT01053455 .
-
-###24281294
-OBJECTIVE	Our goal was to develop and validate , based on theoretical and empirical knowledge , the Pain Assessment Checklist for Seniors with Limited Ability to Communicate ( PACSLAC-II ) , a shorter tool that would improve on the PACSLAC , while addressing limitations of the original version .
-METHODS	The PACSLAC was revised based on the relevant clinical and theoretical literature .
-METHODS	Psychometric properties and clinical utility of the resulting 31-item PACSLAC-II were examined .
-METHODS	Specifically , the PACSLAC-II was used to assess pain based on video footage of long-term care ( LTC ) residents with dementia undergoing painful procedures as part of routine care .
-METHODS	Its ability to discriminate pain from non-pain-related states was compared with that of preexisting pain assessment tools using archival data .
-METHODS	A second phase involved the use of the PACSLAC and PACSLAC-II by LTC staff to solicit feedback from health care providers .
-METHODS	Mixed-methods analysis of this feedback was conducted .
-RESULTS	The PACSLAC-II demonstrated satisfactory reliability , excellent validity , and ability to differentiate between pain and nonpain states .
-RESULTS	The PACSLAC-II also accounted for unique variance in differentiating between pain and nonpain states , even after controlling for the preexisting tools combined , including the PACSLAC .
-RESULTS	The PACSLAC-II was also preferred by many LTC nurses and care aides , because of its length and condensed nature , which was thought to facilitate documentation and greater efficiency in pain management .
-CONCLUSIONS	Findings indicate that the empirical and theoretically driven revisions to the PACSLAC led to improved ability to differentiate between pain and nonpain states , while retaining its clinical utility .
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-###25113047
-OBJECTIVE	The lipid layer plays a major role in limiting evaporation of the tear film .
-OBJECTIVE	Based on interference phenomena , there is a test directed to lipid layer pattern ( LLP ) evaluation , but is affected by subjective interpretation of the patterns .
-OBJECTIVE	The aim of this study is to compare the LLP evaluation between two experienced observers on a group of healthy patients .
-OBJECTIVE	Furthermore , observers re-evaluated the same images to check their individual repeatability .
-METHODS	LLP was examined using a Tearscope-plus ( Keeler , Windsor , UK ) attached to a slit lamp .
-METHODS	Tear film was recorded by a Topcon DV-3 digital camera video and LLP images were captured .
-METHODS	This yielded 124 LLP images that were categorized ( based on Guillon 's scheme ) by two expert observers in two sessions separated by one month .
-METHODS	Interobserver repeatability and intraobserver repeatability between both sessions were studied by using Cohen 's kappa coefficient .
-RESULTS	Comparing LLP categorization between both observers , Cohen 's kappa coefficient was 0.615 and 0.633 for first and second session , respectively .
-RESULTS	When comparing LLP categorization by the same observer between both sessions , Cohen 's kappa coefficient was 0.770 and 0.812 for Observer 1 and Observer 2 , respectively .
-RESULTS	These results indicate substantial correlation in all cases .
-RESULTS	The most frequent misinterpretations were between open and closed meshwork and Wave and closed meshwork patterns .
-CONCLUSIONS	Although substantial correlation was found between categorizations of experienced observers , misinterpretation of the patterns may appear even in the same observer .
-CONCLUSIONS	Some misinterpretations between adjacent patterns could be palliated by including intermediate patterns between those categories .
-
-###24311443
-OBJECTIVE	Estrogen-based hormone therapy ( HT ) attenuates abdominal fat gain after menopause , but whether HT improves abdominal fat loss during weight loss is unknown .
-OBJECTIVE	It was hypothesized that HT or a selective estrogen receptor modulator ( raloxifene ) would augment reductions in abdominal visceral fat during weight loss when compared to placebo , potentially increasing improvements in glucose tolerance and lipid profile .
-METHODS	Healthy postmenopausal women ( n = 119 ; age 50-70 yr ) underwent a 6-month weight-loss ( primarily exercise ) intervention with randomization to raloxifene ( 60 mg/d ) , HT ( conjugated estrogens , 0.625 mg/d ) , or placebo .
-METHODS	Outcomes were change in total and abdominal ( visceral and subcutaneous ) fat mass , lipid profile , and fasting and post-challenge glucose and insulin .
-RESULTS	Neither HT nor raloxifene augmented loss of total or abdominal fat mass during exercise-induced weight loss when compared with placebo .
-RESULTS	Weight loss-induced improvements in risk factors were similar among the three groups , except for a greater reduction in fasted glucose in the HT group ( difference in change [ 95 % CI ] from placebo ; -0.40 [ -0.76 , -0.05 ] ) and greater reductions in LDL ( -0.36 [ -0.63 , -0.09 ] ) and increases in HDL ( 0.15 [ 0.07 , 0.24 ] ) in both treatment groups .
-CONCLUSIONS	Postmenopausal HT and raloxifene did not increase abdominal fat loss during weight loss , but did improve some cardiometabolic outcomes .
-
-###24813620
-OBJECTIVE	A subset analysis of the randomised , phase 3 , MDS-004 study to evaluate outcomes in patients with International Prognostic Scoring System ( IPSS ) - defined Low - / Intermediate ( Int ) -1 - risk myelodysplastic syndromes ( MDS ) with isolated del ( 5q ) .
-METHODS	Patients received lenalidomide 10mg/d ( days 1-21 ; n = 47 ) or 5mg/d ( days 1-28 ; n = 43 ) on 28-d cycles or placebo ( n = 45 ) .
-METHODS	From the placebo and lenalidomide 5mg groups , 84 % and 58 % of patients , respectively , crossed over to lenalidomide 5 or 10mg at 16wk , respectively .
-RESULTS	Rates of red blood cell-transfusion independence ( RBC-TI ) 182d were higher in the lenalidomide 10mg ( 57.4 % ; P < 0.0001 ) and 5mg ( 37.2 % ; P = 0.0001 ) groups vs. placebo ( 2.2 % ) .
-RESULTS	Cytogenetic response rates ( major + minor responses ) were 56.8 % ( P < 0.0001 ) , 23.1 % ( P = 0.0299 ) and 0 % , respectively .
-RESULTS	Two-year cumulative risk of acute myeloid leukaemia progression was 12.6 % , 17.4 % and 16.7 % in the lenalidomide 10mg , 5mg , and placebo groups , respectively .
-RESULTS	In a 6-month landmark analysis , overall survival was longer in lenalidomide-treated patients with RBC-TI 182d vs. non-responders ( P = 0.0072 ) .
-RESULTS	The most common grade 3-4 adverse event was myelosuppression .
-CONCLUSIONS	These data support the clinical benefits and acceptable safety profile of lenalidomide in transfusion-dependent patients with IPSS-defined Low - / Int-1-risk MDS with isolated del ( 5q ) .
-
-###24250307
-BACKGROUND	Weight loss studies were conducted in children without asthma have demonstrated a reduction in systemic inflammation .
-BACKGROUND	However , the impact of weight loss in the obese paediatric population with asthma has not been investigated .
-OBJECTIVE	To measure the effects of weight loss on markers of systemic inflammation in obese children with bronchial asthma .
-METHODS	Eighty obese children with bronchial asthma ( 42 boys , and 38 girls ) with mean age 13.86 3.21 years were divided into two equal groups .
-METHODS	The training group received diet regimen , exercise training in addition to the medical treatment for two months , where the control group received the medical treatment only .
-RESULTS	There was a 17.5 % , 15.5 % , 22.4 % , 14.1 % and 15.9 % reduction in mean values of tumor necrosis factor-alpha ( TNF-alpha ) , interleukin-6 ( IL-6 ) , interleukin-8 ( IL-8 ) , Leptin and body mass index ( BMI ) respectively and 38.7 % increase in mean values of adiponectin in the training group .
-RESULTS	While , there was a 0.7 % , 9.0 % , 2.8 % , 1.6 % and 1.2 % increase in mean values of TNF-alpha , IL-6 , IL-8 , Leptin and BMI respectively and 3.9 % decrease in mean values of adiponectin in the control group .
-RESULTS	The mean values of TNF-alpha , IL-6 , IL-8 , Leptin and BMI was decreased and adiponectin was increased significantly in the training group , however the results of the control group were not significant .
-RESULTS	Also , there were significant differences between both groups at the end of the study .
-CONCLUSIONS	Weight loss improves markers of systemic inflammation in obese Saudi children with bronchial asthma .
-
-###25296243
-OBJECTIVE	To achieve an excellent bowel preparation , it is routine to require a clear liquid diet on the day before the procedure .
-OBJECTIVE	Unfortunately , this dietary modification may be poorly tolerated .
-OBJECTIVE	We examine whether a change in precolonoscopy dietary restriction can lead to better patient tolerance without compromising examination quality .
-METHODS	This is a prospective , blinded , randomized controlled trial of patients undergoing screening or surveillance colonoscopy .
-METHODS	The primary objective measures the effect of dietary modification on bowel prep quality .
-METHODS	Secondary endpoints include polyp detection , patient tolerance , withdrawal time , and patient acceptance .
-METHODS	A total of 200 patients were randomized to either ( a ) a low-residue diet for breakfast and lunch the day before the procedure or ( b ) clear liquids all day before the procedure .
-METHODS	All patients underwent an identical low-volume sodium sulfate split prep .
-METHODS	Bowel prep quality was scored using the Boston Bowel Preparation Scale ( BBPS ) .
-METHODS	A t test with TOST was used for noninferiority .
-METHODS	Secondary endpoints were compared using analysis .
-RESULTS	Overall , 96.5 % of patients had a good or excellent bowel prep ( BBPS = 6 , 7 , 8 , or 9 ) .
-RESULTS	LRD prep quality was noninferior to CLD prep quality ( LRD 7.8 vs. CLD 8.1 ) .
-RESULTS	Polyp detection rates were similar ( 68 % vs. 65.4 % , P = 0.6899 ) .
-RESULTS	Patient tolerance and acceptance did not differ .
-RESULTS	Withdrawal times were equivalent between both groups ( 16.2 vs. 16.5 min , P = NS ) .
-CONCLUSIONS	Patients allowed to have a limited low-residue diet before colonoscopy achieve a bowel prep quality that is noninferior to patients on a strict clear liquid diet limitation .
-CONCLUSIONS	Furthermore , polyp detection rates , patient tolerance , and patient acceptance were similar between the 2 groups .
-
-###24220161
-BACKGROUND	Prenatal supplementation with micronutrients may increase birth weight and thus improve infant health and survival in settings where infants and children are at risk of micronutrient deficiencies .
-OBJECTIVE	To assess whether vitamin A and/or zinc supplementation given during pregnancy can improve birth weight , birth length , neonatal morbidity , or infant mortality .
-METHODS	A double-blind , randomized controlled trial supplementing women ( n = 2173 ) in Central Java , Indonesia throughout pregnancy with vitamin A , zinc , combined vitamin A + zinc , or placebo .
-RESULTS	Out of 2173 supplemented pregnant women , 1956 neonates could be evaluated .
-RESULTS	Overall , zinc supplementation improved birth length compared to placebo or combined vitamin A + zinc ( 48.8 vs. 48.5 cm , p = 0.04 ) ; vitamin A supplementation improved birth length compared to placebo or combined vitamin A + zinc ( 48.7 vs. 48.2 cm , p = 0.04 ) .
-RESULTS	These effects remained after adjusting for maternal height , pre-pregnancy weight , and parity .
-RESULTS	There was no effect of supplementation on birth weight , the proportion of low birth weight , neonatal morbidity , or mortality .
-CONCLUSIONS	Prenatal zinc or vitamin A supplementation demonstrates a small but significant effect on birth length , but supplementation with zinc , vitamin A or a combination of zinc and vitamin A , have no effect on birth weight , neonatal morbidity , or mortality .
-
-###25739878
-BACKGROUND	Chikungunya is an emerging arthropod-borne disease that has spread from tropical endemic areas to more temperate climates of the USA and Europe .
-BACKGROUND	However , no specific treatment or preventive measure is yet available .
-BACKGROUND	We aimed to investigate the immunogenicity and safety of a live recombinant measles-virus-based chikungunya vaccine .
-METHODS	We did a randomised , double-blind , placebo-controlled , active-comparator , phase 1 , dose-escalation study at one centre in Vienna , Austria .
-METHODS	Healthy men and women aged 18-45 years with no comorbidities were randomly assigned , by computer-generated block randomisation ( block size of 14 ) , to receive either one of three escalating doses of the measles-virus-based candidate vaccine ( low dose [ 1510 ( 4 ) median tissue culture infection doses ( TCID50 ) per 005 mL ] , medium dose [ 7510 ( 4 ) TCID50 per 025 mL ] , or high dose [ 3010 ( 5 ) TCID50 per 10 mL ] ) , or the active comparator-Priorix .
-METHODS	Participants were additionally block-randomised to receive a booster injection on either day 28 or day 90 after the first vaccination .
-METHODS	Participants and study investigators were masked to group allocation .
-METHODS	The primary endpoint was the presence of neutralising anti-chikungunya antibodies on day 28 , as assessed by 50 % plaque reduction neutralisation test .
-METHODS	Analysis was by intention to treat and per protocol .
-METHODS	This trial is registered with EudraCT , number 2013-001084-23 .
-RESULTS	Between Nov 22 , 2013 , and Feb 25 , 2014 , we randomly assigned 42 participants to receive the low dose ( n = 12 ) , the medium dose ( n = 12 ) , or the high dose ( n = 12 ) of the measles-virus-based candidate vaccine , or Priorix ( n = 6 ) , of whom 36 participants ( 86 % ; n = 9 , n = 12 , n = 10 , n = 5 , respectively ) were included in the per-protocol population .
-RESULTS	The candidate vaccine raised neutralising antibodies in all dose cohorts after one immunisation , with seroconversion rates of 44 % ( n = 4 ) in the low-dose group , 92 % ( n = 11 ) in the medium-dose group , and 90 % ( n = 10 ) in the high-dose group .
-RESULTS	The immunogenicity of the candidate vaccine was not affected by pre-existing anti-measles immunity .
-RESULTS	The second vaccination resulted in a 100 % seroconversion for all participants in the candidate vaccine groups .
-RESULTS	The candidate vaccine had an overall good safety profile , and the rate of adverse events increased with vaccine dose and volume .
-RESULTS	No vaccination-related serious adverse events were recorded .
-CONCLUSIONS	The live recombinant measles-virus-based chikungunya vaccine had good immunogenicity , even in the presence of anti-vector immunity , was safe , and had a generally acceptable tolerability profile .
-CONCLUSIONS	This vaccine is the first promising measles-virus-based candidate vaccine for use in human beings .
-BACKGROUND	Themis Bioscience GmBH .
-
-###24286965
-BACKGROUND	Diabetes mellitus is an independent risk factor for cardiovascular disease .
-OBJECTIVE	To compare the efficacy of devices for continuous glucose monitoring and capillary glucose monitoring in hospitalized patients with acute coronary syndrome using the following parameters : time to achieve normoglycemia , period of time in normoglycemia , and episodes of hypoglycemia .
-METHODS	We performed a pilot , non-randomized , unblinded clinical trial that included 16 patients with acute coronary artery syndrome , a capillary or venous blood glucose 140 mg/dl , and treatment with a continuous infusion of fast acting human insulin .
-METHODS	These patients were randomized into 2 groups : a conventional group , in which capillary measurement and recording as well as insulin adjustment were made every 4h , and an intervention group , in which measurement and recording as well as insulin adjustment were made every hour with a subcutaneous continuous monitoring system .
-METHODS	Student 's t-test was applied for mean differences and the X ( 2 ) test for qualitative variables .
-RESULTS	We observed a statistically significant difference in the mean time for achieving normoglycemia , favoring the conventional group with a P = 0.02 .
-CONCLUSIONS	Continuous monitoring systems are as useful as capillary monitoring for achieving normoglycemia .
-
-###25206313
-BACKGROUND	The use of a video-assisted laryngoscope ( VL ) has been shown to reduce the time to achieve intubation with a double-lumen endobronchial tube ( DLT ) .
-BACKGROUND	As the blade of the VL is curved differently to a standard laryngoscope , the DLT must be angled into a hockey stick shape to fit properly .
-BACKGROUND	We conducted a study to establish which direction of angulation was best to facilitate correct positioning of the DLT when using a VL .
-METHODS	We enrolled patients scheduled for thoracic surgery who required intubation with a DLT .
-METHODS	They were prospectively randomized into one of two groups : those intubated with a DLT angled to conceal the tracheal orifice ( the tracheal orifice-covered , TOC ) group or the tracheal orifice-exposed ( TOE ) group .
-METHODS	The composite primary outcome measures were time taken to intubate and the frequency of first-time success .
-METHODS	The time taken to intubate was divided into : T1 , the time from mouth opening to visualization of the vocal cords with the VL ; and T2 , the time taken to advance the DLT through the cords until its tip lay within the trachea and three carbon dioxide waveforms had been detected by capnography .
-METHODS	The hemodynamic responses to intubation and intubation-related adverse events were also recorded .
-RESULTS	Sixty-six patients completed the study , with 33 in each group .
-RESULTS	Total intubation time was significantly shorter in the TOC group ( mean 30.6 standard deviation 2.7 seconds versus 38.73.3 seconds , p < 0.0001 ) .
-RESULTS	T2 was also significantly shorter in the TOC group than the TOE group ( 27.22.5 seconds versus 34.93.0 seconds , p < 0.0001 ) .
-RESULTS	The severity of hoarseness on the first postoperative day and sore throat on the fourth postoperative day were significantly lower in the TOC group than the TOE group ( p = 0.02 and < 0.0001 , respectively ) .
-RESULTS	The hemodynamic responses to intubation were broadly similar between the groups .
-CONCLUSIONS	When placing a left-sided DLT using a VL , angling the bronchial lumen to a hockey stick shape that conceals the tracheal lumen saves time and ameliorates the severity of post-intubation complications .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT01605591 .
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-###24867893
-OBJECTIVE	The aim of this study was to investigate the comparison of massage therapy and routine physical therapy on patients with sub acute and chronic nonspecific low back pain .
-METHODS	Thirty volunteer female subjects with a sub acute or chronic nonspecific low back pain were randomly enrolled in two groups , massage therapy and routine physical therapy .
-METHODS	After massage application , the hamstring and paravertebral muscles stretching and also stabilizing exercises were prescribed .
-METHODS	In the routine physical therapy group , TENS , US and vibrator were used besides exercises .
-METHODS	Pain intensity according to Numerical Rating Scale , functional disability level in accordance to Oswestry Disability Index , and modified Schober test , for measurement of flexion range of motion , before and after ten sessions of treatment were used to evaluate the effectiveness of the treatment .
-RESULTS	Pain intensity , Oswestry Disability Index and flexion range of motion had shown significant differences before and after intervention in both groups ( p < 0.001 ) .
-RESULTS	The statistical analysis revealed that the massage therapy had significantly improved the pain intensity and Oswestry Disability Index compared to routine physical therapy ( p = 0.015 , p = 0.013 respectively ) , but the range of motion changes were not significant between two groups ( p = 1.00 ) .
-CONCLUSIONS	It can be concluded that both massage therapy and routine physical therapy are useful for sub acute and chronic nonspecific low back pain treatment especially if accompanied with exercise .
-CONCLUSIONS	However , massage is more effective than other electrotherapy modalities , and it can be used alone or with electrotherapy for the treatment of patients with low back pain .
-
-###25208756
-OBJECTIVE	The aim of this study was to compare the efficacy and safety of once-weekly albiglutide with once-daily insulin glargine ( A21Gly , B31Arg , B32Arg human insulin ) in patients with type 2 diabetes inadequately controlled on metformin with or without sulfonylurea .
-METHODS	This was a randomised , open-label , multicentre ( n = 222 ) , parallel-group , non-inferiority out-patient clinical trial , with 779 patients enrolled in the study .
-METHODS	The study was conducted in 222 centres located in four countries .
-METHODS	Patients aged 18 years with type 2 diabetes treated with metformin ( sulfonylurea ) for at least 3 months with a baseline HbA1c 7.0-10 .0 % ( 53.0-85 .8 mmol/mol ) were randomly assigned ( 2:1 ) via a computer-generated randomisation sequence with a voice response system to receive albiglutide ( 30 mg once a week , n = 504 ) or insulin glargine ( 10 U once a day , n = 241 ) added to current therapy .
-METHODS	Participants and investigators were not masked to treatment assignment .
-METHODS	Doses of each medication were adjusted on the basis of the glycaemic response .
-METHODS	The primary endpoint was change from baseline in HbA1c at week 52 .
-RESULTS	In the albiglutide group , HbA1c declined from 8.280.90 % ( 67.09.8 mmol/mol ) ( meanSD ) at baseline to 7.621.12 % ( 59.812.2 mmol/mol ) at week 52 .
-RESULTS	A similar reduction occurred in the insulin glargine group ( 8.360.95 % to 7.551.04 % [ 67.910.4 to 59.011.4 mmol/mol ] ) .
-RESULTS	The model-adjusted treatment difference of 0.11 % ( 95 % CI -0.04 % , 0.27 % ) ( 1.2 mmol/mol [ 95 % CI -0.4 , 3.0 mmol/mol ] ) indicated non-inferiority of albiglutide to insulin glargine based on the pre-specified non-inferiority margin of 0.3 % ( 3.3 mmol/mol , p = 0.0086 ) .
-RESULTS	Body weight increased in the insulin glargine group and decreased in the albiglutide group , with a mean treatment difference of -2.61 kg ( 95 % CI -3.20 , -2.02 ; p < 0.0001 ) .
-RESULTS	Documented symptomatic hypoglycaemia occurred in a higher proportion of patients in the insulin glargine group than in the albiglutide group ( 27.4 % vs 17.5 % , p = 0.0377 ) .
-CONCLUSIONS	Albiglutide was non-inferior to insulin glargine at reducing HbA1c at week 52 , with modest weight loss and less hypoglycaemia .
-CONCLUSIONS	Both drugs were well tolerated .
-CONCLUSIONS	Albiglutide may be considered an alternative to insulin glargine in this patient population .
-BACKGROUND	ClinicalTrials.gov NCT00838916 ( completed )
-BACKGROUND	This study was planned and conducted by GlaxoSmithKline .
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-###25096954
-BACKGROUND	Cervical dilatation documented on partogram indicates expected rate of progress of labour and deviations from alert line indicates abnormal progress of labour .
-BACKGROUND	Its early detection and timely intervention can reduce fetomaternal morbidity .
-OBJECTIVE	To study the role of partogram in the management of labouring mothers with high risk pregnancies at a tertiary care centre .
-METHODS	Four hundred primigravidas with high risk pregnancies in active labour ( with cervical dilatation 4 cm ) were studied , divided into two groups as Partogram and no Partogram group and each group consisted of 200 patients .
-METHODS	In Partogram group , progress of labour was documented on modified WHO partograph along with the notes on progress sheet of case record file while by standard notes only in no Partogram group .
-METHODS	Cases included were pregnancy-induced hypertension , gestational diabetes mellitus , cholestasis , hypothyroidism , history of previous one LSCS for trial of labour , postdated pregnancy .
-METHODS	Management of labour was standardised using set protocols of intrapartum care followed by analysis of duration of labour , rate of intervention , maternal and perinatal outcomes in both group .
-RESULTS	Though percentage of normal vaginal delivery was higher in Partogram group ( 71.5 % ) than no Partogram group ( 68 % ) , no statistically significant difference was found between two groups regarding mean duration of active phase of first and second stage of labour , rate of operative vaginal deliveries ( partogram 12 % and no partogram 12.5 % ) and of caesarean section ( Partogram 16.5 % , no Partogram 18.5 % ) and perinatal outcome .
-CONCLUSIONS	In this study , partogram had no significant impact on duration of labour , rate of operative interventions and perinatal outcome following its use in the labour management of high risk pregnancies .
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-###25458076
-OBJECTIVE	To evaluate how soft lens power affects rigid gas-permeable ( RGP ) lens power and visual acuity ( VA ) in piggyback fittings for keratoconus .
-METHODS	Sixteen keratoconus subjects ( 30 eyes ) were included in the study .
-METHODS	Piggyback contact lens fittings combining Senofilcon-A soft lenses of -6.00 , -3.00 , +3.00 and +6.00 D with Rose K2 RGP contact lenses were performed .
-METHODS	Corneal topography was taken on the naked eye and over each soft contact lens before fitting RGP lenses .
-METHODS	Mean central keratometry , over-refraction , RGP back optic zone radius ( BOZR ) and estimated final power as well as VA were recorded and analyzed .
-RESULTS	In comparison to the naked eye , the mean central keratometry flattened with both negative lens powers ( p < 0.05 in all cases ) , did not change with the +3.00 soft lens power ( p = 1.0 ) ; and steepened with the +6.00 soft lens power ( p = 0.02 ) .
-RESULTS	Rigid gas-permeable over-refraction did not change significantly between different soft lens powers ( all p > 0.05 ) .
-RESULTS	RGP 's BOZR decreased significantly with both positive in comparison with both negative soft lens powers ( all p < 0.001 ) , but no significant differences were found among negative - or positive-powers separately ( both p > 0.05 ) .
-RESULTS	Estimated RGP 's final power increased significantly with positive in comparison with negative lens powers ( all p < 0.001 ) , but no significant differences were found among negative or positive lens powers separately ( both p > 0.05 ) .
-RESULTS	Visual acuity did not change significantly between the different soft lens powers assessed ( all p > 0.05 ) .
-CONCLUSIONS	The use of negative-powered soft lenses in piggyback fitting reduces RGP lens power without impacting VA in keratoconus subjects .
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-###24456698
-BACKGROUND	Leading medical organizations have called on primary care pediatricians to take a central role in the prevention of childhood obesity .
-BACKGROUND	Weight counseling typically has not been incorporated into routine pediatric practice due to time and training constraints .
-BACKGROUND	Brief interventions with simple behavior change messages are needed to reach high-risk children , particularly Latino and Black children who are disproportionately affected by obesity and related comorbidities .
-BACKGROUND	Steps to Growing Up Healthy ( Added Value ) is a randomized controlled trial testing the efficacy of brief motivational counseling ( BMC ) delivered by primary care clinicians and the added value of supplementing BMC with monthly contact by community health workers ( CHW ) in the prevention/reversal of obesity in Latino and Black children ages 2-4years old .
-METHODS	Mother-child dyads ( targeted n = 150 ) are recruited for this 12-month randomized trial at an inner-city pediatric primary care clinic and randomized to : 1 ) BMC delivered by clinicians and nurses at well , sick , and WIC visits with the goal of reducing obesogenic behaviors ( BMC ) ; 2 ) BMC plus monthly phone calls by a CHW ( BMC+P hone ) ; or 3 ) BMC plus monthly home visits by a CHW ( BMC+H ome ) .
-METHODS	During BMC , the medical team facilitates the selection of a specific goal ( i.e. , reduce sugar sweetened beverage consumption ) that is meaningful to the mother and teaches the mother simple behavioral strategies .
-METHODS	Monthly contacts with CHWs are designed to identify and overcome barriers to goal progress .
-METHODS	Dyads are assessed at baseline and 12months and the primary outcome is change in the child 's BMI percentile .
-METHODS	We hypothesize that BMC+P hone and BMC+H ome will produce greater reductions in BMI percentiles than BMC alone and that BMC+H ome will produce greater reductions in BMI percentiles than BMC+P hone .
-CONCLUSIONS	Steps to Growing Up Healthy will provide important information about whether a brief primary care-based intervention that utilizes a motivational interviewing and goal setting approach can be incorporated into routine care and is sufficient to prevent/reverse obesity in young children .
-CONCLUSIONS	The study will also explore whether monthly contact with a community health worker bridges the gap between the clinic and the community and is an effective strategy for promoting obesity prevention in high-risk families .
-BACKGROUND	ClinicalTrials.gov NCT01973153 .
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-###24392793
-OBJECTIVE	To examine the associations between treatment/outcome expectations , alliance before and during treatment , and the impact of alliance on symptomatic improvement .
-METHODS	One hundred and fifty-three depressed patients randomized to dynamic supportive-expressive psychotherapy ( SET ) , antidepressant medication ( ADM ) or placebo ( PBO ) + clinical management completed ratings of treatment expectations , therapeutic alliance ( CALPAS , WAI-S ) , and depressive symptoms ( HAM-D ) .
-RESULTS	Pretreatment expectations of the therapeutic alliance were significantly related to alliance later in therapy but did not differ across treatments and did not predict outcome .
-RESULTS	Alliance development over time differed between treatments ; it increased more in SET than in PBO .
-RESULTS	After controlling for prior symptom improvement , early alliance predicted subsequent depression change .
-CONCLUSIONS	Expectations of alliance and of treatment outcome/improvement , measured prior to treatment onset , predicted subsequent alliance .
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-###24337328
-BACKGROUND	Successful implementation is a vital precondition for investigating the outcome of care innovation .
-BACKGROUND	This study concerned the evaluation of the implementation of integrated emotion-oriented care ( IEOC ) in psychogeriatric nursing home wards .
-BACKGROUND	The main question was whether the trained caregivers actually applied the knowledge and techniques of IEOC during their daily work .
-METHODS	The study was conducted within the framework of a randomized clinical trial into the effectiveness of IEOC in 16 wards .
-METHODS	Preceding the experimental period , staff from 16 wards were educated and trained to work with a standardized care plan , resulting in a similar level of quality of care at the start of the trial .
-METHODS	On the experimental wards IEOC was then implemented by training on the job in addition to training courses for personnel .
-METHODS	To examine the implementation effectiveness , a self-report questionnaire , 'Em otion-oriented Skills in the Interaction with Elderly People with Dementia ' , was administered at baseline and after 7 months to a sample of caregivers from the experimental and the control wards .
-METHODS	In addition , participant observation was conducted on four experimental and four control wards , and time spent by care personnel on different type of care tasks was registered .
-RESULTS	The implementation of IEOC resulted in increased emotion-oriented skills and more knowledge of the residents among the caregivers .
-RESULTS	Providing IEOC was not more time consuming for the caregivers than providing usual care .
-CONCLUSIONS	This study shows that the implementation of IEOC was effective .
-CONCLUSIONS	It is recommended that in intervention studies the correct application of a new intervention or care approach is examined before jumping to conclusions about the effectiveness of the intervention or care approach itself .
-
-###24577972
-BACKGROUND	Randomized trials of complex , non-pharmacologic interventions implemented in home and community settings , such as the University of Southern California ( USC ) - Rancho Los Amigos National Rehabilitation Center ( RLANRC ) Pressure Ulcer Prevention Study ( PUPS ) , present unique challenges with respect to ( 1 ) participant recruitment and retention , ( 2 ) intervention delivery and fidelity , ( 3 ) randomization and assessment , and ( 4 ) potential inadvertent treatment effects .
-OBJECTIVE	We describe the methods employed to address the challenges confronted in implementing PUPS .
-OBJECTIVE	In this randomized controlled trial , we are assessing the efficacy of a complex , preventive intervention in reducing the incidence of , and costs associated with , the development of medically serious pressure ulcers in people with spinal cord injury .
-METHODS	Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group .
-METHODS	The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries , medical treatment costs , and quality of life .
-METHODS	These outcomes are assessed at 12 and 24 months after randomization .
-METHODS	Additionally , we are studying the mediating mechanisms that account for intervention outcomes .
-RESULTS	PUPS has been successfully implemented , including recruitment of the target sample size of 170 participants , assurance of the integrity of intervention protocol delivery with an average 90 % treatment adherence rate , and enactment of the assessment plan .
-RESULTS	However , implementation has been replete with challenges .
-RESULTS	To meet recruitment goals , we instituted a five-pronged approach customized for an underserved , ethnically diverse population .
-RESULTS	In intervention delivery , we increased staff time to overcome economic and cultural barriers to retention and adherence .
-RESULTS	To ensure treatment fidelity and replicability , we monitored intervention protocol delivery in accordance with a rigorous plan .
-RESULTS	Finally , we have overcome unanticipated assessment and design concerns related to ( 1 ) determining pressure ulcer incidence/severity , ( 2 ) randomization imbalance , and ( 3 ) inadvertent potential control group contamination .
-CONCLUSIONS	We have addressed the most daunting challenges encountered in the recruitment , assessment , and intervention phases of PUPS .
-CONCLUSIONS	Some challenges and solutions may not apply to trials conducted in other settings .
-CONCLUSIONS	Overcoming challenges has required a multifaceted approach incorporating individualization , flexibility , and persistence , as well as the ability to implement needed mid-course corrections .
-
-###24429305
-BACKGROUND	The therapeutic effects of antiretroviral treatment ( ART ) in patients with multidrug-resistant tuberculosis ( MDR-TB ) and human immunodeficiency virus ( HIV ) infection have not been established .
-OBJECTIVE	To assess therapeutic outcomes of integrating ART with treatment for MDR-TB .
-METHODS	A subgroup of MDR-TB patients from a randomised controlled trial , the SAPiT ( Starting Antiretroviral Therapy at Three Points in Tuberculosis ) study , conducted in an out-patient clinic in Durban , South Africa , from 2008 to 2012 .
-METHODS	Clinical outcomes at 18 months were compared in patients randomised to receive ART within 12 weeks of initiating standard first-line anti-tuberculosis treatment with those who commenced ART after completing anti-tuberculosis treatment .
-RESULTS	Mycobacterium tuberculosis drug susceptibility results were available in 489 ( 76 % ) of 642 SAPiT patients : 23 had MDR-TB , 14 in the integrated treatment arm and 9 in the sequential treatment arm .
-RESULTS	At 18 months , the mortality rate was 11.9 / 100 person-years ( py ; 95 % CI 1.4-42 .8 ) in the combined integrated treatment arm and 56.0 / 100 py ( 95 % CI 18.2-130 .8 ) in the sequential treatment arm ( hazard ratio adjusted for baseline CD4 count and whether MDR-TB treatment was initiated : 0.14 ; 95 % CI 0.02-0 .94 , P = 0.04 ) .
-CONCLUSIONS	Despite the small sample size , the 86 % reduction in mortality due to early initiation of ART in MDR-TB patients was statistically significant .
-
-###24991995
-OBJECTIVE	To evaluate the effects of propofol , etomidate , and thiopental administered during phacoemulsification ( PE ) cataract extraction on intraocular pressure ( IOP ) and hemodynamic responses with insertion of laryngeal mask airway ( LMA ) .
-METHODS	In a randomized double-blind clinical trial , patients scheduled for PE with general anesthesia were included .
-METHODS	Patients were allocated randomly to 3 groups : group 1 ( n = 34 ) : 0.3 mg/kg etomidate ; group 2 ( n = 33 ) : 2mg/kg propofol ; and group 3 ( n = 34 ) : 4mg/kg thiopental .
-METHODS	IOP , systolic blood pressure , and heart rate ( HR ) were measured before induction as a baseline , 2min after induction ( immediately before insertion of LMA ) , and 1 and 3min after LMA insertion .
-METHODS	Blood pressure ( BP ) and HR of patients during the surgery were monitored and registered before and after induction and intubation .
-RESULTS	In 3 groups , IOP decreased significantly after injection of drugs and insertion of LMA in comparison to basic values , although IOP after LMA insertion was more than before LMA insertion .
-RESULTS	In case of propofol , the changes in IOP between 2min after induction and the baseline were higher than others , especially thiopental ( P = 0.031 ) .
-RESULTS	BP declined remarkably after induction ( P < 0.001 ) and rose significantly after LMA insertion in all groups , except in the propofol group .
-RESULTS	The HR was decreased significantly after induction , except in thiopental .
-CONCLUSIONS	Propofol prevented IOP increase after induction compared with other drugs .
-CONCLUSIONS	Decrease in BP and HR after induction and LMA insertion was remarkable .
-CONCLUSIONS	Thiopental seemed to be the best drug for controlling cardiovascular parameters , especially HR , and it also prevents IOP rise .
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-###25599775
-OBJECTIVE	Different drug combinations are used for sedation in colonoscopy procedures .
-OBJECTIVE	A ketamine-propofol ( ketofol ) mixture provides effective sedation and has minimal adverse effects .
-OBJECTIVE	Alfentanil also provides anesthesia for short surgical procedures by incremental injection as an adjunct .
-OBJECTIVE	However , no study has investigated the use of ketofol compared with an opioid-propofol combination in colonoscopic procedures .
-METHODS	A total of 70 patients , ASA physical status I-II , scheduled to undergo elective colonoscopy , were enrolled in this prospective randomized study and allocated to two groups .
-METHODS	After premedication , sedation induction was performed with 0.5 mg/kg ketamine +1 mg/kg propofol in Group KP , and 10 mg/kg alfentanil +1 mg/kg propofol in Group AP .
-METHODS	Propofol was added when required .
-METHODS	Demographic data , colonoscopy duration , recovery time , discharge time , mean arterial pressure ( MAP ) , heart rate ( HR ) , peripheral oxygen saturation , Ramsey Sedation Scale values , colonoscopy patients ' satisfaction scores , and complications were recorded .
-RESULTS	The need for additional propofol doses was significantly higher in Group AP than in Group KP .
-RESULTS	MAP at minute 1 and 5 , Ramsey Sedation Scale at minute 5 , and discharge time were significantly higher in Group KP than in Group AP .
-RESULTS	Additional propofol doses and total propofol dose were significantly lower in Group KP than in Group AP .
-CONCLUSIONS	Ketofol provided better hemodynamic stability and quality of sedation compared with alfentanil-propofol combination in elective colonoscopy , and required fewer additional propofol ; however , it prolonged discharge time .
-CONCLUSIONS	Both combinations can safely be used in colonoscopy sedation .
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-###25592205
-OBJECTIVE	Feasibility and efficacy of computerized auditory cognitive training ( ACT ) was examined among patients with heart failure ( HF ) .
-BACKGROUND	Individuals with HF have four times increased risk of cognitive impairment , yet cognitive intervention studies are sparse .
-METHODS	A pilot randomized controlled design was used .
-RESULTS	The ACT group ( n = 9 ) and control group ( n = 8 ) had similar baseline characteristics .
-RESULTS	Seven participants ( 78 % ) completed 18 hours of ACT .
-RESULTS	Medium effect sizes were observed for improved cognition as indicated by auditory processing speed ( d = 0.78 ) , speech processing ( d = 0.88 ) , and working memory ( d = 0.44-0 .50 ) .
-RESULTS	Small effect sizes were found for improved functional outcomes including HF selfcare ( d = 0.34 ) , Timed Instrumental Activities of Daily Living ( d = 0.32 ) , Six-Minute Walk Test ( d = 0.38 ) and Short-Form-36 ( d = 0.22 ) relative to controls .
-CONCLUSIONS	Results indicated ACT is feasible among persons with HF .
-CONCLUSIONS	Despite a small sample size , ACT showed potential for improved speed of processing and working memory and improved functional outcomes , and warrants further exploration .
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-###25037206
-OBJECTIVE	Impulse control disorders ( ICDs ) in Parkinson disease ( PD ) are common and can be difficult to manage .
-OBJECTIVE	The objective of this study was to determine the efficacy and tolerability of naltrexone , an opioid antagonist , for the treatment of ICDs in PD .
-METHODS	Patients with PD ( n = 50 ) and an ICD were enrolled in an 8-week , randomized ( 1:1 ) , double-blind , placebo-controlled study of naltrexone 50-100 mg/d ( flexible dosing ) .
-METHODS	The primary outcome measure was response based on the Clinical Global Impression-Change score , and the secondary outcome measure was change in symptom severity using the Questionnaire for Impulsive-Compulsive Disorders in Parkinson 's Disease-Rating Scale ( QUIP-RS ) ICD score .
-RESULTS	Forty-five patients ( 90 % ) completed the study .
-RESULTS	The Clinical Global Impression-Change response rate difference favoring naltrexone in completers was 19.8 % ( 95 % confidence interval [ CI ] -8.7 % to 44.2 % ) .
-RESULTS	While this difference was not significant ( odds ratio = 1.6 , 95 % CI 0.5-5 .2 , Wald 2 [ df ] = 0.5 [ 1 ] , p = 0.5 ) , naltrexone treatment led to a significantly greater decrease in QUIP-RS ICD score over time compared with placebo ( regression coefficient for interaction term in linear mixed-effects model = -7.37 , F [ df ] = 4.3 [ 1 , 49 ] , p = 0.04 ) .
-RESULTS	The estimated changes in QUIP-RS ICD scores from baseline to week 8 were 14.9 points ( 95 % CI 9.9-19 .9 ) for naltrexone and 7.5 points ( 95 % CI 2.5-12 .6 ) for placebo .
-CONCLUSIONS	Naltrexone treatment was not efficacious for the treatment of ICDs in PD using a global assessment of response , but findings using a PD-specific ICD rating scale support further evaluation of opioid antagonists for the treatment of ICD symptoms in PD .
-METHODS	This study provides Class I evidence that in patients with PD and an ICD , naltrexone does not significantly increase the probability of achieving response .
-METHODS	However , the study lacked the precision to exclude an important difference in response rates .
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-###25117806
-OBJECTIVE	Elevated low-density lipoprotein cholesterol ( LDL-C ) is a major modifiable risk factor for cardiovascular disease ( CVD ) , a leading cause of death in the United States .
-OBJECTIVE	Despite clinical practice guidelines aimed at facilitating LDL-C control , many Veterans do not achieve guideline-recommended LDL-C levels .
-METHODS	We describe a study focused on VA healthcare system users at risk for CVD ( i.e. , LDL-C level > 130 mg/dl and/or < 80 % cholesterol pill refill adherence in the last 12 months ) .
-METHODS	We are conducting a two and a half year randomized controlled trial ( i.e. , intervention administered over 12 months ) among Veterans with uncontrolled cholesterol receiving care at select VA-affiliated primary care clinics in North Carolina .
-METHODS	We anticipate enrolling 250 diverse patients ( 10 % women ; 40 % African American ) .
-METHODS	Patients are randomized to an educational control group or intervention group .
-METHODS	Intervention group participants ' medication is provided in special blister packaging labeled for daily use that includes reminders ; MeadWestvaco Corporation 's pre-filled DosePak contains standard doses of statins in accordance with the existing prescriptions .
-CONCLUSIONS	Pre-filled blister packaging may provide an inexpensive solution to improve medication adherence .
-CONCLUSIONS	Our study enrolls a diverse sample and provides information about whether an adherence packaging intervention can : 1 ) improve medication adherence ; 2 ) improve patients ' LDL-C levels ; 3 ) be well received by patients and providers ; and 4 ) provide a cost effective solution to improve medication adherence .
-
-###25092775
-OBJECTIVE	One third of patients with triple-negative breast cancer ( TNBC ) achieve pathologic complete response ( pCR ) with standard neoadjuvant chemotherapy ( NACT ) .
-OBJECTIVE	CALGB 40603 ( Alliance ) , a 2 2 factorial , open-label , randomized phase II trial , evaluated the impact of adding carboplatin and/or bevacizumab .
-METHODS	Patients ( N = 443 ) with stage II to III TNBC received paclitaxel 80 mg/m ( 2 ) once per week ( wP ) for 12 weeks , followed by doxorubicin plus cyclophosphamide once every 2 weeks ( ddAC ) for four cycles , and were randomly assigned to concurrent carboplatin ( area under curve 6 ) once every 3 weeks for four cycles and/or bevacizumab 10 mg/kg once every 2 weeks for nine cycles .
-METHODS	Effects of adding these agents on pCR breast ( ypT0/is ) , pCR breast/axilla ( ypT0/isN0 ) , treatment delivery , and toxicities were analyzed .
-RESULTS	Patients assigned to either carboplatin or bevacizumab were less likely to complete wP and ddAC without skipped doses , dose modification , or early discontinuation resulting from toxicity .
-RESULTS	Grade 3 neutropenia and thrombocytopenia were more common with carboplatin , as were hypertension , infection , thromboembolic events , bleeding , and postoperative complications with bevacizumab .
-RESULTS	Employing one-sided P values , addition of either carboplatin ( 60 % v 44 % ; P = .0018 ) or bevacizumab ( 59 % v 48 % ; P = .0089 ) significantly increased pCR breast , whereas only carboplatin ( 54 % v 41 % ; P = .0029 ) significantly raised pCR breast/axilla .
-RESULTS	More-than-additive interactions between the two agents could not be demonstrated .
-CONCLUSIONS	In stage II to III TNBC , addition of either carboplatin or bevacizumab to NACT increased pCR rates , but whether this will improve relapse-free or overall survival is unknown .
-CONCLUSIONS	Given results from recently reported adjuvant trials , further investigation of bevacizumab in this setting is unlikely , but the role of carboplatin could be evaluated in definitive studies , ideally limited to biologically defined patient subsets most likely to benefit from this agent .
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-###24317366
-OBJECTIVE	Impaired regulation of lipid oxidation ( metabolic inflexibility ) is associated with obesity and type 2 diabetes mellitus .
-OBJECTIVE	Recent evidence has indicated that dietary polyphenols may modulate mitochondrial function , substrate metabolism and energy expenditure in humans .
-OBJECTIVE	The present study investigated the effects of short-term supplementation of two combinations of polyphenols on energy expenditure ( EE ) and substrate metabolism in overweight subjects .
-METHODS	Eighteen healthy overweight volunteers ( 9 women , 9 men ; age 352.5 years ; body mass index 28.90.4 kgm ( -2 ) ) participated in a randomized , double-blind cross-over trial .
-METHODS	Combinations of epigallocatechin-gallate ( E , 282mgday ( -1 ) ) + resveratrol ( R , 200mgday ( -1 ) ) and E+R +80 mgday ( -1 ) soy isoflavones ( S ) or placebo capsules ( PLA ) were supplemented twice daily for a period of 3 days .
-METHODS	On day 3 , circulating metabolite concentrations , EE and substrate oxidation ( using indirect calorimetry ) were measured during fasting and postprandial conditions for 6h ( high-fat-mixed meal ( 2.6 MJ , 61.2 E % fat ) ) .
-RESULTS	Short-term supplementation of E+R increased resting EE ( E+R vs PLA : 5.450.24 vs 5.230.25 kJmin ( -1 ) , P = 0.039 ) , whereas both E+R ( 69918kJ120min ( -1 ) vs 67620kJ120min ( -1 ) , P = 0.028 ) and E+R+S ( 70418kJ120min ( -1 ) vs 67620kJ120min ( -1 ) , P = 0.014 ) increased 2-4h-postprandial EE compared with PLA .
-RESULTS	Metabolic flexibility , calculated as the postprandial increase to the highest respiratory quotient achieved , tended to be improved by E+R compared with PLA and E+R+S only in men ( E+R vs PLA : 0.110.02 vs 0.060.02 , P = 0.059 ; E+R+S : 0.030.02 , P = 0.009 ) .
-RESULTS	E+R+S significantly increased fasting plasma free fatty acid ( P = 0.064 ) and glycerol ( P = 0.021 ) concentrations compared with PLA .
-CONCLUSIONS	We demonstrated for the first time that combined E+R supplementation for 3 days significantly increased fasting and postprandial EE , which was accompanied by improved metabolic flexibility in men but not in women .
-CONCLUSIONS	Addition of soy isoflavones partially reversed these effects possibly due to their higher lipolytic potential .
-CONCLUSIONS	The present findings may imply that long-term supplementation of these dosages of epigallocatechin-gallate combined with resveratrol may improve metabolic health and body weight regulation .
-
-###24854612
-OBJECTIVE	Acute pancreatitis ( AP ) is a disease typically requiring in-hospital treatment .
-OBJECTIVE	We conducted a trial to assess the feasibility of early discharge from the hospital for patients with mild non-alcoholic acute pancreatitis ( NAAP ) .
-METHODS	Eighty-four patients with mild NAAP were randomized to home or hospital groups after a short hospital stay ( 24h ) .
-METHODS	AP was defined by the revised Atlanta criteria .
-METHODS	Mild AP was defined as an Imrie score5 and a harmless acute pancreatitis score ( HAPS ) 2 in the first 24-h of presentation .
-METHODS	A nurse visited all patients in the home group on the 2nd , 3rd and 5th days .
-METHODS	All patients presented for follow-up in clinic on the 7th , 14th , and 30th days .
-METHODS	The primary outcome was the time to resolution of pain .
-METHODS	Secondary outcomes evaluated included time to resumption of an oral diet , 30 day hospital readmission rate as well as the total costs associated with either approach to care .
-RESULTS	There was no difference between the groups with regards to demographics , prognostic severity scores , symptoms , and biliary findings .
-RESULTS	No patients developed organ failure , pancreatic necrosis , or died in either group .
-RESULTS	Time to the resolution of pain and resumption of solid food intake were similar .
-RESULTS	Three ( 3.6 % ) patients required readmission within 30 days , 1 from home and 2 from the hospital groups .
-RESULTS	The total cost was significantly less in home group ( $ 13973 vs. $ 951715 , p < 0.001 ) .
-CONCLUSIONS	Mild NAAP can be safely treated at home with regular visits by a nurse under the supervision of a physician .
-CONCLUSIONS	Widespread adoption of this practice may result in large cost savings .
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-###24629989
-OBJECTIVE	Clopidogrel plays a central role in the treatment of patients undergoing carotid artery stenting ( CAS ) .
-OBJECTIVE	The objective was to evaluate the effect of clopidogrel ( 75 mg/d ) on platelet reactivity in responders and nonresponders and the antiplatelet effect of different doses of clopidogrel in patients with high on-treatment reactivity ( OTR ) after CAS .
-METHODS	Patients with high OTR ( defined by VerifyNow ( Accumetrics , San Diego , Calif ) assay as 230 P2Y12 reaction units [ PRU ] ) were randomly assigned in a 1:1 ratio to group 1 ( standard-dose clopidogrel therapy : 75 mg/d for 30 days ) or group 2 ( high-dose clopidogrel : 150 mg/d for 30 days ) .
-RESULTS	The study enrolled 214 patients .
-RESULTS	Of these , 115 ( 53.7 % ) were clopidogrel responders ( group 0 ) , and 99 ( 46.3 % ) had high OTR ( clopidogrel nonresponders ) ; of which , 50 were randomly assigned to group 1 and 49 to group 2 .
-RESULTS	At baseline , the PRU value did not differ between group 1 ( 288.50 46 ) and group 2 ( 295.45 47.2 ; P = .308 ) .
-RESULTS	Patients displayed reduced mean platelet reactivity levels at 30 days in group 1 ( 238.96 72.25 ; P < .001 ) and group 2 ( 201.85 77.8 ; P < .001 ) .
-RESULTS	Although high-dose clopidogrel resulted in more intense platelet function inhibition , the differences between median 30-day PRU values ( P = .483 ) and the percentage change of PRU ( P = .442 ) for groups 1 and 2 were not significant .
-RESULTS	The incidences of transient ischemic attack , stroke , or death at up to 30 days after CAS in the high-OTR patients were similar between groups 1 and 2 ( P = .481 ) .
-CONCLUSIONS	Patients with high OTR undergoing CAS treated with standard-dose and double-dose clopidogrel had significantly reduced platelet reactivity after 30 days .
-CONCLUSIONS	The double dose did not result in statistically significantly greater reductions in reactivity compared with the standard dose .
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-###25354951
-BACKGROUND	Home-based exercise training in cardiac rehabilitation ( CR ) has the potential to improve CR uptake , decrease costs and increase self-management skills .
-BACKGROUND	The FIT@Home study evaluates home-based CR with telemonitoring guidance using coaching interventions including strategies for behavioural changes with the aim to maintain adherence to a healthy lifestyle and to improve long-term effects .
-BACKGROUND	In this interim analysis we provide short-term results on exercise capacity , quality of life and training adherence of the first 50 patients included in the FIT@Home study .
-METHODS	The study design was a randomised controlled trial .
-METHODS	Low to moderate risk CR patients were randomised to a 12-week home-based training ( HT ) programme or a 12-week centre-based training ( CT ) programme .
-METHODS	In both groups , training was performed at 70-85 % of maximal heart rate ( HRmax ) for 45-60min , 2-3 times per week .
-METHODS	The HT group received three supervised training sessions , before commencing training with a heart rate monitor in their home environment .
-METHODS	These patients received individual coaching by telephone weekly , based on training data uploaded on the Internet .
-METHODS	The CT programme was performed under the direct supervision of a physical therapist .
-METHODS	Exercise capacity and health-related quality of life were assessed at baseline and at 12 weeks .
-RESULTS	CT ( n = 25 ) and HT ( n = 25 ) both showed a significant improvement in peak oxygen uptake ( peak VO2 ) ( 10 % and 14 % respectively ) and quality of life after 12 weeks of training , without significant between-group differences .
-RESULTS	The average training intensity of the HT group was 73.33.5 % of HRmax .
-RESULTS	Training adherence was similar between groups .
-CONCLUSIONS	This analysis shows that HT with telemonitoring guidance has similar short-term effects on exercise capacity and quality of life as CT in CR patients .
-
-###24887106
-BACKGROUND	Both exposure to hypoxia and exercise training have the potential to modulate appetite and induce beneficial metabolic adaptations .
-BACKGROUND	The purpose of this study was to determine whether daily moderate exercise training performed during a 10-day exposure to normobaric hypoxia alters hormonal appetite regulation and augments metabolic health .
-METHODS	Fourteen healthy , male participants underwent a 10-day hypoxic confinement at 4000 m simulated altitude ( FIO2 = 0.139 0.003 % ) either combined with daily moderate intensity exercise ( Exercise group ; N = 8 , Age = 25.8 2.4 yrs , BMI = 22.9 1.2 kg m ( -2 ) ) or without any exercise ( Sedentary group ; N = 6 Age = 24.8 3.1 yrs , BMI = 22.3 2.5 kg m ( -2 ) ) .
-METHODS	A meal tolerance test was performed before ( Pre ) and after the confinement ( Post ) to quantify fasting and postp randial concentrations of selected appetite-related hormones and metabolic risk markers .
-METHODS	13C-Glucose was dissolved in the test meal and 13CO2 determined in breath samples .
-METHODS	Perceived appetite ratings were obtained throughout the meal tolerance tests .
-RESULTS	While body mass decreased in both groups ( -1.4 kg ; p = 0.01 ) following the confinement , whole body fat mass was only reduced in the Exercise group ( -1.5 kg ; p = 0.01 ) .
-RESULTS	At Post , postprandial serum insulin was reduced in the Sedentary group ( -49 % ; p = 0.01 ) and postprandial plasma glucose in the Exercise group ( -19 % ; p = 0.03 ) .
-RESULTS	Fasting serum total cholesterol levels were reduced ( -12 % ; p = 0.01 ) at Post in the Exercise group only , secondary to low-density lipoprotein cholesterol reduction ( -16 % ; p = 0.01 ) .
-RESULTS	No differences between groups or testing periods were noted in fasting and/or postprandial concentrations of total ghrelin , peptide YY , and glucagon-like peptide-1 , leptin , adiponectin , expired 13CO2 as well as perceived appetite ratings ( p > 0.05 ) .
-CONCLUSIONS	These findings suggest that performing daily moderate intensity exercise training during continuous hypoxic exposure does not alter hormonal appetite regulation but can improve the lipid profile in healthy young males .
-
-###25732936
-BACKGROUND	The use of Web-based apps to promote a healthy lifestyle is increasing , although most of these programs were not assessed using suitable epidemiological methods .
-BACKGROUND	We evaluated the effectiveness of a newly developed Web-based app in promoting a healthy lifestyle and educating adults on such lifestyles .
-BACKGROUND	We also analyzed predictors for success in acquiring and maintaining a healthy lifestyle .
-OBJECTIVE	Our aim was to compare people receiving a new Web-based app with people who got an introductory lecture alone on healthy lifestyle , weight change , nutritional knowledge , and physical activity , and to identify predictors of success for maintaining a healthy lifestyle .
-METHODS	Subjects were recruited from the community and were randomized into intervention and control groups .
-METHODS	The intervention subjects received access to the app without any face-to-face support ; the control subjects continued their standard lifestyle .
-METHODS	Measurements were taken by the researcher at baseline and after 14 weeks and included weight and waist circumference .
-METHODS	Nutritional knowledge , diet quality , and physical activity duration were obtained using online questionnaires .
-METHODS	The new Web-based app was developed based on current US Department of Agriculture and Israel Ministry of Health recommendations for healthy lifestyle .
-METHODS	The app provides tools for monitoring diet and physical activity while instructing and encouraging healthy diet and physical activity .
-RESULTS	Out of 99 subjects who were randomized into app and control groups , 85 participants ( 86 % ) completed the study , 56 in the intervention and 29 in the control group .
-RESULTS	The mean age was 47.9 ( SD 12.3 ) years , and mean Body Mass Index was 26.2 ( SD 3.9 ) .
-RESULTS	Among the intervention group only , frequency of app use was 2.7 ( SD 1.9 ) days/week .
-RESULTS	The mean change in physical activity was 63 ( SD 20.8 ) minutes in the app group and -30 ( SD 27.5 ) minutes in the control group ( P = .02 ) .
-RESULTS	The mean weight change was -1.44 ( SD 0.4 ) kg in the app group and -0.128 ( SD 0.36 ) kg in the control group ( P = .03 ) .
-RESULTS	Knowledge score increased significantly in the app group , 76 ( SD 7.5 ) to 79 ( SD 8.7 ) at the end of the study ( P = .04 ) compared with the control group .
-RESULTS	Diet quality score also increased significantly at the end of the study , from 67 ( SD 9.8 ) to 71 ( SD 7.6 ; P < .001 ) in contrast to the control group .
-RESULTS	Success score ( represents the success in maintaining healthy lifestyle ) was higher among the app group ( 68 % ) compared with 36 % in the control group ( P < .001 ) .
-RESULTS	The app frequency of use was significantly related to a higher success score ( P < .001 ) .
-CONCLUSIONS	We showed a positive impact of a newly developed Web-based app on lifestyle indicators during an intervention of 14 weeks .
-CONCLUSIONS	These results are promising in the app 's potential to promote a healthy lifestyle , although larger and longer duration studies are needed to achieve more definitive conclusions .
-BACKGROUND	Clinicaltrial.gov number : NCT01913496 ; http://www.clinicaltrials.gov/ct2/show/NCT01913496 ( Archived by WebCite at http://www.webcitation.org/6WSTUEPuJ ) .
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-###24232052
-BACKGROUND	Peroral endoscopic myotomy ( POEM ) has recently been introduced as a promising alternative to laparoscopic Heller myotomy for idiopathic achalasia .
-BACKGROUND	Several proposed technical modifications are yet to be tested in randomized trials .
-OBJECTIVE	The objective of our study was to evaluate efficacy and safety of water-jet ( WJ ) assisted POEM versus the conventional ( C ) technique .
-OBJECTIVE	The clinical trial registration number is NCT01742494 .
-METHODS	A prospective randomized trial was carried out in Zhongshan Hospital , Fudan University ( Shanghai , China ) , in 100 consenting achalasia patients between August 2011 and April 2012 .
-METHODS	Patients eligible for POEM were randomized to use of either the HybridKnife ( WJ group ) or the conventional technique using injection and triangle tip knife interchangeably ( C group ) .
-RESULTS	A total of 100 patients with comparable characteristics between groups were included .
-RESULTS	Procedure time was significantly shorter for the WJ group ( 22.9 6.7 vs. 35.9 11.7 min ; p < 0.0001 ) , mostly due to less replacement of accessories ( 2.0 2.4 vs. 19.2 7.6 ; p < 0.0001 ) .
-RESULTS	Injection volume was larger in the WJ group ( 45.3 10.2 vs. 35.2 9.5 ml ; p < 0.0001 ) and was associated with fewer minor bleeding episodes ( 3.6 1.8 vs. 6.8 5.2 ; p < 0.0001 ) .
-RESULTS	No severe complications occurred ; one case of cutaneous emphysema occurred in the WJ group , and four cases occurred in the C group ( p = 0.17 ) , three cases of pneumonia were encountered in the C group and none in the WJ group ( p = 0.24 ) .
-RESULTS	Treatment success ( Eckardt score 3 ) was achieved in 96.5 % of patients , with no significant differences between groups .
-CONCLUSIONS	The use of the HybridKnife leads to a significant decrease in POEM procedure time and facilitates reinjection , possibly contributing to a lower rate of minor intra-procedural bleeding .
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-###25313848
-OBJECTIVE	The aim of the present study was to determine whether specific biochemical and energy concentrations influence gastric emptying of unfortified and fortified mother 's own milk ( MOM ) in stable preterm infants , and whether gastric emptying differs between feeds of unfortified MOM and feeds fortified with S-26 or FM 85 human milk fortifier ( HMF ) when infants are fed the same volume under similar conditions .
-OBJECTIVE	Influences of infant gestation , age , and weight , and feed characteristics were also explored .
-METHODS	Stomach volumes of 25 paired unfortified and fortified MOM feeds were monitored prefeed and postfeed delivery and at 30-minute intervals thereafter .
-METHODS	For each feed , MOM samples were analyzed to determine concentrations of total protein , casein , whey , carbohydrate , lactose , fat , and energy .
-METHODS	Fortified feed compositions were calculated by adding fortifier biochemical and energy concentrations to unfortified MOM concentrations .
-METHODS	Ultrasound images were used to calculate infant stomach volumes .
-METHODS	Statistical comparisons were made of paired stomach volume measurements .
-RESULTS	Higher feed concentrations of casein were associated with faster gastric emptying during feed delivery ( P = 0.007 ) .
-RESULTS	When compared with unfortified MOM , S-26 fortified feeds emptied similarly , whereas FM 85 fortified feeds emptied more slowly both during feed delivery and during the postprandial period ( P = 0.002 , < 0.001 , respectively ) .
-RESULTS	Gastric emptying was slower for 2-hourly feeds compared with that for 3-hourly feeds ( P = 0.003 ) and in supine position compared with that in prone ( P = 0.001 ) .
-CONCLUSIONS	Breast milk composition influences gastric emptying in stable preterm infants , with feeds of higher casein concentration emptying faster during feeding than otherwise equivalent feeds , and FM 85 fortified MOM emptying more slowly than unfortified MOM .
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-###24710470
-BACKGROUND	Newly emerging evidence showed that glucocorticoids could potentiate natriuretic peptides ' action by increasing the density of natriuretic peptide receptor A , leading to a potent diuresis and a renal function improvement in patients with acute decompensated heart failure ( ADHF ) .
-BACKGROUND	Therefore , glucocorticoid therapy may be used in patients with ADHF .
-METHODS	One hundred two patients with ADHF were randomized to receive glucocorticoids or standard treatment .
-METHODS	Change from baseline in serum creatinine ( SCr ) at day 7 and cardiovascular death within 30 days were recorded .
-METHODS	The study was terminated early because of slow site initiation and patient enrolment .
-RESULTS	Glucocorticoid therapy seemed to be well tolerated .
-RESULTS	There was a remarkable SCr reduction after 7 days treatment .
-RESULTS	The change from baseline in SCr is -0.14 mg/dL in glucocorticoid group versus -0.02 mg/dL in standard treatment group ( P < 0.05 ) .
-RESULTS	Although sample size is limited , a cardiovascular death reduction at 30 days was observed in glucocorticoid group with odds ratio of 0.26 ( 3 deaths in glucocorticoid vs. 10 deaths in standard treatment group , P < 0.05 ) .
-RESULTS	The survival benefit associated with glucocorticoid therapy persisted during the follow-up .
-RESULTS	Patient-assessed dyspnea and physician-assessed global clinical status were also improved in glucocorticoid group .
-CONCLUSIONS	Limited data indicate that glucocorticoid therapy may be used safely in patients with ADHF in short term .
-CONCLUSIONS	Glucocorticoid therapy did not cause heart failure deterioration .
-CONCLUSIONS	Further investigations are warranted .
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-###24965132
-BACKGROUND	Hip fractures are a common type of fragility fracture that afflict 293,000 Americans ( over 5,000 per week ) and 35,000 Canadians ( over 670 per week ) annually .
-BACKGROUND	Despite the large population impact the optimal fixation technique for low energy femoral neck fractures remains controversial .
-BACKGROUND	The primary objective of the FAITH study is to assess the impact of cancellous screw fixation versus sliding hip screws on rates of revision surgery at 24 months in individuals with femoral neck fractures .
-BACKGROUND	The secondary objective is to determine the impact on health-related quality of life , functional outcomes , health state utilities , fracture healing , mortality and fracture-related adverse events .
-METHODS	FAITH is a multi-centre , multi-national randomized controlled trial utilizing minimization to determine patient allocation .
-METHODS	Surgeons in North America , Europe , Australia , and Asia will recruit a total of at least 1,000 patients with low-energy femoral neck fractures .
-METHODS	Using central randomization , patients will be allocated to receive surgical treatment with cancellous screws or a sliding hip screw .
-METHODS	Patient outcomes will be assessed at one week ( baseline ) , 10 weeks , 6 , 12 , 18 , and 24 months post initial fixation .
-METHODS	We will independently adjudicate revision surgery and complications within 24 months of the initial fixation .
-METHODS	Outcome analysis will be performed using a Cox proportional hazards model and likelihood ratio test .
-CONCLUSIONS	This study represents major international efforts to definitively resolve the treatment of low-energy femoral neck fractures .
-CONCLUSIONS	This trial will not only change current Orthopaedic practice , but will also set a benchmark for the conduct of future Orthopaedic trials .
-BACKGROUND	The FAITH trial is registered at ClinicalTrials.gov ( Identifier NCT00761813 ) .
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-###25275693
-OBJECTIVE	Compare mechanical and pharmacological ripening for patients with oligohydramnios at term .
-METHODS	Fifty-two patients with oligohydramnios 5 cm and Bishop score 6 were randomized for labor induction with a vaginal insert containing 10 mg timed-release dinoprostone ( PGE2 ) or double-balloon catheter .
-METHODS	The primary outcome was time from induction to active labor .
-METHODS	Time to labor , neonatal outcomes and maternal satisfaction were also compared .
-RESULTS	Baseline characteristics were similar .
-RESULTS	Time from induction to active labor ( 13 with PGE2 vs 19.5 h with double-balloon catheter ; P = 0.243 ) was comparable , with no differences in cesarean rates ( 15.4 vs 7.7 % ; P = 0.668 ) or neonatal outcomes .
-RESULTS	The PGE2 group had higher incidence of early device removal ( 76.9 vs 26.9 % ; P = 0.0001 ) , mostly because of active labor or non-reassuring fetal heart rate .
-RESULTS	Fewer PGE2 patients required oxytocin augmentation for labor induction ( 53.8 vs 84.6 % P = 0.034 ) .
-RESULTS	Time to delivery was significantly shorter with PGE2 ( 16 vs 20.5 h ; P = 0.045 ) .
-CONCLUSIONS	Intravaginal PGE2 and double-balloon catheter are comparable methods for cervical ripening in term pregnancies with oligohydramnios .
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-###24534317
-OBJECTIVE	To explore the efficacy and safety of remifentanyl and propofol injection in total intravenous anesthesia for percutaneous radiofrequency ablation .
-METHODS	60 patients scheduled for PRFA were divided randomly into two groups : group A and group B. Each group contained 30 patients .
-METHODS	Those in group A received remifentanyl and propofol injection , and the patients in group B were given oxycodone hydrochloride .
-METHODS	The mean arterial pressure ( MAP ) , heart rate ( HR ) and pulse oxygen saturation ( SPO2 ) were measured and recorded by monitor during the operation .
-METHODS	The chest muscle rigidity , respiratory depression , nausea and vomitting , hypotensio and VAS were also recorded .
-RESULTS	Compared with the preoperative , MAP , HR in group A decreased significantly during the operation , increased in group B ( P < 0.05 ) .
-RESULTS	VAS was significantly lower in group A than that in group B ( P < 0.05 ) .
-RESULTS	2 patients had respiratory depression , 1 patient had nausea and vomiting reaction in group A. 2 patients had vagus reflex , 3 patient had nausea and vomitting reaction in group B.
-CONCLUSIONS	Total intravenous anesthesia with remifentanyl and propofol for PRFA is safe and reliable .
-CONCLUSIONS	Respiratory and circulation should be monitored instantly and strictly .
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-###24990275
-BACKGROUND	NOX-2 , the catalytic subunit of NADPH oxidase , has a key role in the formation of reactive oxidant species and is implicated in impairing flow-mediated dilation ( FMD ) .
-BACKGROUND	Dark chocolate exerts artery dilatation via down-regulating NOX2-mediated oxidative stress .
-BACKGROUND	The aim of this study was to investigate whether dark chocolate improves walking autonomy in peripheral artery disease ( PAD ) patients via an oxidative stress-mediated mechanism .
-RESULTS	FMD , serum levels of isoprostanes , nitrite/nitrate ( NOx ) and sNOX2-dp , a marker of blood NOX2 activity , maximal walking distance ( MWD ) and maximal walking time ( MWT ) were studied in 20 PAD patients ( 14 males and 6 females , mean age : 699 years ) randomly allocated to 40 g of dark chocolate ( > 85 % cocoa ) or 40 g of milk chocolate ( 35 % cocoa ) in a single blind , cross-over design .
-RESULTS	The above variables were assessed at baseline and 2 hours after chocolate ingestion .
-RESULTS	Dark chocolate intake significantly increased MWD ( +11 % ; P < 0.001 ) , MWT ( +15 % ; P < 0.001 ) , serum NOx ( +57 % ; P < 0.001 ) and decreased serum isoprostanes ( -23 % ; P = 0.01 ) and sNOX2-dp ( -37 % ; P < 0.001 ) ; no changes of the above variables were observed after milk chocolate intake .
-RESULTS	Serum epicatechin and its methylated metabolite significantly increased only after dark chocolate ingestion .
-RESULTS	Multiple linear regression analysis showed that of MWD was independently associated with of MWT ( P < 0.001 ) and of NOx ( P = 0.018 ) .
-RESULTS	In vitro study demonstrated that HUVEC incubated with a mixture of polyphenols significantly increased nitric oxide ( P < 0.001 ) and decreased E-selectin ( P < 0.001 ) and VCAM1 ( P < 0.001 ) .
-CONCLUSIONS	In PAD patients dark but not milk chocolate acutely improves walking autonomy with a mechanism possibly related to an oxidative stress-mediated mechanism involving NOX2 regulation .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01947712 .
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-###25399012
-OBJECTIVE	BK virus infection is a significant complication of modern immunosuppression used in kidney transplantation .
-OBJECTIVE	Viral reactivation occurs first in the urine ( BK viruria ) and is associated with a high risk of transplant failure .
-OBJECTIVE	There are currently no therapies to prevent or treat BK virus infection .
-OBJECTIVE	Quinolone antibiotics have antiviral properties against BK virus but efficacy at preventing this infection has not been shown in prospective controlled studies .
-OBJECTIVE	To determine if levofloxacin can prevent BK viruria in kidney transplant recipients .
-METHODS	Double-blind , placebo-controlled randomized trial involving 154 patients who received a living or deceased donor kidney-only transplant in 7 Canadian transplant centers between December 2011 and June 2013 .
-METHODS	Participants were randomly assigned to receive a 3-month course of levofloxacin ( 500 mg/d ; n = 76 ) or placebo ( n = 78 ) starting within 5 days after transplantation .
-METHODS	The primary outcome was time to occurrence of BK viruria ( detected using quantitative real-time polymerase chain reaction ) within the first year after transplantation .
-METHODS	Secondary outcomes included BK viremia , peak viral load , rejection , and patient and allograft survival .
-RESULTS	The mean follow-up time was 46.5 weeks in the levofloxacin group and 46.3 weeks in the placebo group ( 27 patients had follow-up terminated before the end of the planned follow-up period or development of viruria because the trial was stopped early owing to lack of funding ) .
-RESULTS	BK viruria occurred in 22 patients ( 29 % ) in the levofloxacin group and in 26 patients ( 33.3 % ) in the placebo group ( hazard ratio , 0.91 ; 95 % CI , 0.51-1 .63 ; P = .58 ) .
-RESULTS	There was no significant difference between the 2 groups in regard to any of the secondary end points .
-RESULTS	There was an increased risk of resistant infection among isolates usually sensitive to quinolones in the levofloxacin group vs placebo ( 14/24 [ 58.3 % ] vs 15/45 [ 33.3 % ] , respectively ; risk ratio , 1.75 ; 95 % CI , 1.01-2 .98 ) as well as a nonsignificant increased risk of suspected tendinitis ( 6/76 [ 7.9 % ] vs 1/78 [ 1.3 % ] ; risk ratio , 6.16 ; 95 % CI , 0.76-49 .95 ) .
-CONCLUSIONS	Among kidney transplant recipients , a 3-month course of levofloxacin initiated early following transplantation did not prevent BK viruria .
-CONCLUSIONS	Levofloxacin was associated with an increased risk of adverse events such as bacterial resistance .
-CONCLUSIONS	These findings do not support the use of levofloxacin to prevent posttransplant BK virus infection .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01353339 .
-
-###24912581
-OBJECTIVE	In myocardial perfusion single-photon emission computed tomography ( SPECT ) , abdominal activity often interferes with the evaluation of perfusion in the inferior wall , especially after pharmacological stress .
-OBJECTIVE	In this randomized study , we examined the effect of carbonated water intake versus still water intake on the quality of images obtained during myocardial perfusion images ( MPI ) studies .
-METHODS	A total of 467 MIBI studies were randomized into a carbonated water group and a water group .
-METHODS	The presence of intestinal activity adjacent to the inferior wall was evaluated by two observers .
-METHODS	Furthermore , a semi-quantitative analysis was performed in the adenosine subgroup , using a count ratio of the inferior myocardial wall and adjacent abdominal activity .
-RESULTS	The need for repeated SPECT in the adenosine studies was 5.3 % in the carbonated water group versus 19.4 % in the still water group ( p = 0.019 ) .
-RESULTS	The inferior wall-to-abdomen count ratio was significantly higher in the carbonated water group compared to the still water group ( 2.11 1.00 vs. 1.72 0.73 , p < 0.001 ) .
-RESULTS	The effect of carbonated water during rest and after exercise was not significant .
-CONCLUSIONS	This randomized study showed that carbonated water significantly reduced the interference of extra-cardiac activity in adenosine SPECT MPI .
-
-###24581993
-BACKGROUND	A hernia repair open surgical simulation computer software was developed at Imperial College London .
-BACKGROUND	A randomized controlled educational trial was conducted to investigate the benefit of the simulation on the development of procedural knowledge .
-METHODS	Medical students in their clinical years were invited to participate in the trial .
-METHODS	Students were block randomized to 4 groups : G1 -- Interactive Simulation ; G2 -- Non-interactive Simulation ; G3 -- Video Tutorial ; G4 -- Control .
-METHODS	On completion , they were objectively assessed on their ability to recall the tasks involved in an open inguinal hernia repair in the form of a multiple choice question ( MCQ ) and a simulated discussion with a consultant surgeon .
-RESULTS	Fifty-six students completed the study .
-RESULTS	Each arm carries similar baseline scores ( pre-intervention MCQ ) with means 43.33 , 38.92 , 38.33 , and 39.57 in G1 to G4 , respectively .
-RESULTS	MCQ score improvements and final assessment scores proved better in the intervention groups ( 1 , 2 , and 3 ) compared to controls .
-CONCLUSIONS	The interactive simulation has shown an objective benefit in teaching medical students the anatomical and procedural knowledge in performing an open inguinal hernia repair .
-
-###24566820
-BACKGROUND	Given the substantial improvements in cancer screening and cancer treatment in the United States , millions of adult cancer survivors live for years following their initial cancer diagnosis and treatment .
-BACKGROUND	However , latent side effects can occur and some symptoms can be alleviated or managed effectively via changes in lifestyle behaviors .
-OBJECTIVE	The purpose of this study was to test the effectiveness of a six-week Web-based multiple health behavior change program for adult survivors .
-METHODS	Participants ( n = 352 ) were recruited from oncology clinics , a tumor registry , as well as through online mechanisms , such as Facebook and the Association of Cancer Online Resources ( ACOR ) .
-METHODS	Cancer survivors were eligible if they had completed their primary cancer treatment from 4 weeks to 5 years before enrollment .
-METHODS	Participants were randomly assigned to the Web-based program or a delayed-treatment control condition .
-RESULTS	In total , 303 survivors completed the follow-up survey ( six months after completion of the baseline survey ) and participants in the Web-based intervention condition had significantly greater reductions in insomnia and greater increases in minutes per week of vigorous exercise and stretching compared to controls .
-RESULTS	There were no significant changes in fruit and vegetable consumption or other outcomes .
-CONCLUSIONS	The Web-based intervention impacted insomnia and exercise ; however , a majority of the sample met or exceeded national recommendations for health behaviors and were not suffering from depression or fatigue at baseline .
-CONCLUSIONS	Thus , the survivors were very healthy and well-adjusted upon entry and their ability to make substantial health behavior changes may have been limited .
-CONCLUSIONS	Future work is discussed , with emphasis placed on ways in which Web-based interventions can be more specifically analyzed for benefit , such as in regard to social networking .
-BACKGROUND	Clinicaltrials.gov NCT00962494 ; http://www.clinicaltrials.gov/ct2/show/NCT00962494 ( Archived by WebCite at http://www.webcitation.org/6NIv8Dc6Q ) .
-
-###25194287
-OBJECTIVE	The GUIDE-IT ( Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure ) study is designed to determine the safety , efficacy , and cost-effectiveness of a strategy of adjusting therapy with the goal of achieving and maintaining a target N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) level of < 1,000 pg/ml compared with usual care in high-risk patients with systolic heart failure ( HF ) .
-BACKGROUND	Elevations in natriuretic peptide ( NP ) levels provide key prognostic information in patients with HF .
-BACKGROUND	Therapies proven to improve outcomes in patients with HF are generally associated with decreasing levels of NPs , and observational data show that decreases in NP levels over time are associated with favorable outcomes .
-BACKGROUND	Results from smaller prospective , randomized studies of this strategy thus far have been mixed , and current guidelines do not recommend serial measurement of NP levels to guide therapy in patients with HF .
-METHODS	GUIDE-IT is a prospective , randomized , controlled , unblinded , multicenter clinical trial designed to randomize approximately 1,100 high-risk subjects with systolic HF ( left ventricular ejection fraction40 % ) to either usual care ( optimized guideline-recommended therapy ) or a strategy of adjusting therapy with the goal of achieving and maintaining a target NT-proBNP level of < 1,000 pg/ml .
-METHODS	Patients in either arm of the study are followed up at regular intervals and after treatment adjustments for a minimum of 12 months .
-METHODS	The primary endpoint of the study is time to cardiovascular death or first hospitalization for HF .
-METHODS	Secondary endpoints include time to cardiovascular death and all-cause mortality , cumulative mortality , health-related quality of life , resource use , cost-effectiveness , and safety .
-CONCLUSIONS	The GUIDE-IT study is designed to definitively assess the effects of an NP-guided strategy in high-risk patients with systolic HF on clinically relevant endpoints of mortality , hospitalization , quality of life , and medical resourceuse .
-CONCLUSIONS	( Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [ GUIDE-IT ] ; NCT01685840 ) .
-
-###24561814
-OBJECTIVE	The effects of short-term high-intensity interval training ( HIT ) on cardiac autonomic function are unclear .
-OBJECTIVE	The present study assessed cardiac autonomic adaptations to short-term HIT in comparison with aerobic endurance training ( AET ) .
-METHODS	Twenty-six healthy middle-age sedentary men were randomized into HIT ( n = 13 , 4-6 30 s of all-out cycling efforts with 4-min recovery ) and AET ( n = 13 , 40-60 min at 60 % of peak workload ) groups , performing six sessions within 2 wk .
-METHODS	The participants underwent a 24-h ECG recording before and after the intervention and , additionally , recorded R-R interval data in supine position ( 5 min ) at home every morning during the intervention .
-METHODS	Mean HR and low-frequency ( LF ) and high-frequency ( HF ) power of R-R interval oscillation were analyzed from these recordings .
-RESULTS	Peak oxygen consumption ( VO2peak ) increased in both groups ( P < 0.001 ) .
-RESULTS	Compared with AET ( n = 11 ) , HIT ( n = 13 ) increased 24-h LF power ( P = 0.024 ) , tended to increase 24-h HF power ( P = 0.068 ) , and increased daytime HF power ( P = 0.038 ) .
-RESULTS	In home-based measurements , supine HF power decreased on the days after HIT ( P = 0.006 , n = 12 ) but not AET ( P = 0.80 , n = 9 ) session .
-RESULTS	The acute response of HF power to HIT session did not change during the intervention .
-CONCLUSIONS	In conclusion , HIT was more effective short-term strategy to increase R-R interval variability than aerobic training , most probably by inducing larger increases in cardiac vagal activity .
-CONCLUSIONS	The acute autonomic responses to the single HIT session were not modified by short-term training .
-
-###25750322
-OBJECTIVE	Biomarkers with prognostic and predictive value can help stratify patients with colorectal cancer ( CRC ) into appropriate treatment groups .
-OBJECTIVE	We sought to evaluate the clinical utility of P53 protein expression as a biomarker in VICTOR , a large phase III trial of rofecoxib in stage II and III CRC .
-METHODS	Tissue micro arrays were constructed from 884 tumors and the expression of P53 was examined by immunohistochemistry .
-METHODS	Tumors were dichotomised as either P53-positive ( nuclear expression in > 10 % of cells or the ` absent ' pattern , both representing TP53 mutation ) or P53-negative ( nuclear expression in < 10 % of cells ) .
-RESULTS	Aberrant P53 expression was found in 65 % ( 482/740 ) of patients .
-RESULTS	It was associated with distal location ( p < 0.001 ) and stage III disease ( p < 0.001 ) .
-RESULTS	No effect was observed on disease-free or overall survival , and there was no interaction with chemotherapy or radiotherapy .
-CONCLUSIONS	Analysis of P53 expression in the patients recruited to the VICTOR trial confirmed that P53 expression is associated with site and stage of CRC .
-CONCLUSIONS	However , independently , this biomarker has neither prognostic nor predictive utility in this cohort of patients .
-
-###24461464
-OBJECTIVE	To assess the efficacy of analgesia provided by continuous ropivacaine wound infiltration after gynecologic laparoscopy .
-METHODS	Sixty patients who underwent gynecologic laparoscopy at Ajou University School of Medicine , Suwon , Republic of Korea , between March and May 2012 were randomized to receive either intravenous fentanyl and ketorolac infusion on demand by patient-controlled analgesia ( IV PCA group , n = 31 ) or continuous wound infiltration of local ropivacaine ( CWI group , n = 29 ) .
-METHODS	Postoperative pain and postoperative nausea and vomiting ( PONV ) were assessed via a visual analog scale .
-METHODS	The number of patients who requested rescue analgesia was recorded .
-RESULTS	There was no significant difference in postoperative pain between the 2 groups , but more patients requested rescue analgesia in the CWI group than in the IV PCA group in 24 hours ( 18 versus 9 patients , respectively ; P = 0.010 ) .
-RESULTS	The PONV scores at 12 and 24 hours were , respectively , 0.28 and 0.27 in the CWI group , and 0.71 and 0.73 in the IV PCA group ( P = 0.004 ) .
-RESULTS	Nine patients requested cessation of IV PCA because of severe nausea or vomiting .
-CONCLUSIONS	Continuous ropivacaine wound infiltration was found to be as effective as patient-controlled analgesia for postoperative pain relief after gynecologic laparoscopy .
-CONCLUSIONS	This technique provides good analgesia with less opioid analgesic requirement and few adverse effects .
-
-###25412862
-OBJECTIVE	To assess the reproducibility of an educational intervention EdAl-2 ( Educaci en Alimentaci ) programme in ` Terres de l'Ebre ' ( Spain ) , over 22 months , to improve lifestyles , including diet and physical activity ( PA ) .
-METHODS	Reproduction of a cluster randomised controlled trial .
-METHODS	Two semi-rural town-group primary-school clusters were randomly assigned to the intervention or control group .
-METHODS	Pupils ( n = 690 ) of whom 320 constituted the intervention group ( 1 cluster ) and 370 constituted the control group ( 1 cluster ) .
-METHODS	Ethnicity was 78 % Western European .
-METHODS	The mean age ( SD ) was 8.040.6 years ( 47.7 % females ) at baseline .
-METHODS	Inclusion criteria for clusters were towns from the southern part of Catalonia having a minimum of 500 children aged 7-8 year ; complete data for participants , including name , gender , date and place of birth , and written informed consent from parents or guardians .
-METHODS	The intervention focused on eight lifestyle topics covered in 12 activities ( 1 h/activity/session ) implemented by health promoting agents in the primary school over three academic years .
-METHODS	The primary outcome was obesity ( OB ) prevalence and the secondary outcomes were body mass index ( BMI ) collected every year and dietary habits and lifestyles collected by questionnaires filled in by parents at baseline and end-of-study .
-RESULTS	At 22 months , the OB prevalence and BMI values were similar in intervention and control groups .
-RESULTS	Relative to children in control schools , the percentage of boys in the intervention group who performed 4 after-school PA h/week was 15 % higher ( p = 0.027 ) , whereas the percentage of girls in both groups remained similar .
-RESULTS	Also , 16.6 % more boys in the intervention group watched 2 television ( TV ) h/day ( p = 0.009 ) , compared to controls ; and no changes were observed in girls in both groups .
-CONCLUSIONS	Our school-based intervention is feasible and reproducible by increasing after-school PA ( to 4 h/week ) in boys .
-CONCLUSIONS	Despite this improvement , there was no change in BMI and prevalence of OB .
-BACKGROUND	Clinical Trials NCT01362023 .
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-###24867575
-OBJECTIVE	Many people consume alcoholic beverages following a period of physical activity that results in fluid loss through sweating ( e.g. , after sports , work ) .
-OBJECTIVE	Adequate rehydration following physical activity may not occur , consequently resulting in the consumption of alcohol in a dehydrated state .
-OBJECTIVE	This may have serious implications for the safety of individuals operating motor vehicles .
-OBJECTIVE	Therefore , this study investigated the impact of mild-moderate dehydration in combination with moderate alcohol consumption on simulated driving performance .
-METHODS	Fourteen healthy males participated in a placebo-controlled crossover design study involving 4 experimental trials ( separated by 4 days or more ) .
-METHODS	In each trial , participants were dehydrated by 2 percent body mass through exercise .
-METHODS	After a 30-min recovery , participants completed a 15-min computerized simulated driving task ( drive 1 ) .
-METHODS	In 2 of the trials , participants were provided with water equivalent to either 50 or 150 percent body mass loss and also received salt capsules ( NaCl , 50 mmol/L ) .
-METHODS	A set volume of alcohol or placebo was then consumed in each trial , incorporating the conditions : dehydration-placebo ( DP ) , dehydration-alcohol ( DA ) , partial rehydration-alcohol ( PA ) , and full rehydration-alcohol ( FA ) .
-METHODS	The volume of the alcoholic beverage was individually calculated and intended to raise the blood alcohol content ( BAC ) to 0.05 percent .
-METHODS	The same driving task was then readministered ( drive 2 ) .
-METHODS	Primary outcome measures of driving consisted of standard deviation of lateral position ( SDLP ) , number of side and center line crossings ( LC ) , number of failures to stop at red traffic signals ( FTS ) , number of impacts/collisions with other vehicles or objects ( IMP ) , and time to collision with a specified lead vehicle ( TTC ) .
-METHODS	In addition , reaction time ( RT ) and incorrect inhibition response ( IIR ) behavior to critical events were collected throughout each experimental drive .
-METHODS	Subjective ratings of mood and estimates of alcohol intoxication and driving impairment were also recorded in each trial .
-RESULTS	No effects of trial condition were observed on any of the driving performance measures or on subjective ratings of mood , alcohol intoxication , and driving impairment .
-RESULTS	SDLP was higher following the consumption of alcohol compared to the placebo trial .
-RESULTS	However , no differences in SDLP were recorded between the alcohol trials , indicating that hydration level had no observable interaction with alcohol to influence SDLP performance .
-CONCLUSIONS	Overall , it appears that dehydration does not exacerbate impairment in driving performance caused by mild-moderate alcohol intoxication .
-CONCLUSIONS	Further research is required to clarify the effects of alcohol and dehydration at various alcohol doses .
-
-###24582486
-BACKGROUND	Carboplatin plus paclitaxel administered every 3 weeks is standard first-line chemotherapy for patients with advanced ovarian cancer .
-BACKGROUND	A weekly paclitaxel schedule combined with carboplatin every 3 weeks prolonged progression-free survival and overall survival in a Japanese phase 3 trial .
-BACKGROUND	The aim of our study was to assess whether a weekly schedule of carboplatin plus paclitaxel is more effective than the same drugs given every 3 weeks .
-METHODS	We did a multicentre , randomised , phase 3 study at 67 institutions in Italy and France .
-METHODS	Women with FIGO stage IC-IV ovarian cancer , an ECOG performance status of 2 or lower , and who had never received chemotherapy were randomly allocated in a 1:1 ratio to receive either carboplatin ( AUC 6 mg/mL per min ) plus paclitaxel ( 175 mg/m ( 2 ) ) every 3 weeks for six cycles or carboplatin ( AUC 2 mg/mL per min ) plus paclitaxel ( 60 mg/m ( 2 ) ) every week for 18 weeks .
-METHODS	Randomisation was done by computer-based minimisation , stratified by centre , residual disease after surgery , and ECOG performance status .
-METHODS	The study was not blinded .
-METHODS	Coprimary endpoints were progression-free survival and quality of life ( assessed by the Functional Assessment of Cancer Therapy Ovarian Trial Outcome Index [ FACT-O/TOI ] score ) , and analysis was by modified intention to treat .
-METHODS	This report presents the final analysis .
-METHODS	The study is registered with ClinicalTrials.gov , number NCT00660842 .
-RESULTS	822 patients were enrolled into the study between Nov 20 , 2008 , and March 1 , 2012 ; 12 withdrew their consent immediately after randomisation and were excluded , and 810 were eligible for analysis .
-RESULTS	404 women were allocated treatment every 3 weeks and 406 were assigned to the weekly schedule .
-RESULTS	After median follow-up of 223 months ( IQR 162-309 ) , 449 progression-free survival events were recorded .
-RESULTS	Median progression-free survival was 173 months ( 95 % CI 152-202 ) in patients assigned to treatment every 3 weeks , versus 183 months ( 168-209 ) in women allocated to the weekly schedule ( hazard ratio 096 , 95 % CI 080-116 ; p = 066 ) .
-RESULTS	FACT-O/TOI scores differed significantly between the two schedules ( treatment-by-time interaction p < 00001 ) ; with treatment every 3 weeks , FACT-O/TOI scores worsened at every cycle ( weeks 1 , 4 , and 7 ) , whereas for the weekly schedule , after transient worsening at week 1 , FACT-O/TOI scores remained stable .
-RESULTS	Fewer patients assigned to the weekly group than those allocated treatment every 3 weeks had grade 3-4 neutropenia ( 167 [ 42 % ] of 399 patients vs 200 [ 50 % ] of 400 patients ) , febrile neutropenia ( two [ 05 % ] vs 11 [ 3 % ] ) , grade 3-4 thrombocytopenia ( four [ 1 % ] vs 27 [ 7 % ] ) , and grade 2 or worse neuropathy ( 24 [ 6 % ] vs 68 [ 17 % ] ) .
-RESULTS	Three deaths during the study were attributed to chemotherapy ; two women died who were allocated treatment every 3 weeks and one death was recorded in the group assigned the weekly regimen .
-CONCLUSIONS	A weekly regimen of carboplatin and paclitaxel might be a reasonable option for first-line treatment of women with advanced ovarian cancer .
-BACKGROUND	None .
-
-###24330893
-OBJECTIVE	Cognitive impairments contribute significantly to inadequate functional recovery following illness episodes in bipolar disorder , yet data on treatment interventions are sparse .
-OBJECTIVE	We assessed the cognitive effects of a standardized extract of the medicinal herb Withania somnifera ( WSE ) in bipolar disorder .
-METHODS	Sixty euthymic subjects with DSM-IV bipolar disorder were enrolled in an 8-week , double-blind , placebo-controlled , randomized study of WSE ( 500 mg/d ) as a procognitive agent added adjunctively to the medications being used as maintenance treatment for bipolar disorder .
-METHODS	Study enrollment and data analyses were completed between December 2008 and September 2012 .
-METHODS	Cognitive testing at baseline and 8 weeks assessed primary efficacy outcomes .
-METHODS	Psychopathology and adverse events were monitored at scheduled visits .
-RESULTS	Fifty-three patients completed the study ( WSE , n = 24 ; placebo , n = 29 ) , and the 2 groups were matched in terms of demographic , illness , and treatment characteristics .
-RESULTS	Compared to placebo , WSE provided significant benefits for 3 cognitive tasks : digit span backward ( P = .035 ) , Flanker neutral response time ( P = .033 ) , and the social cognition response rating of the Penn Emotional Acuity Test ( P = .045 ) .
-RESULTS	The size of the WSE treatment effect for digit span backward was in the medium range ( Cohen d = 0.51 ; 95 % CI , 0.25-0 .77 ) .
-RESULTS	None of the other cognitive tasks showed significant between-group differences .
-RESULTS	Mood and anxiety scale scores remained stable , and adverse events were minor .
-CONCLUSIONS	Although results are preliminary , WSE appears to improve auditory-verbal working memory ( digit span backward ) , a measure of reaction time , and a measure of social cognition in bipolar disorder .
-CONCLUSIONS	Given the paucity of data for improving cognitive capacity in bipolar disorder , WSE offers promise , appears to have a benign side-effects profile , and merits further study .
-BACKGROUND	ClinicalTrials.gov identifier : NCT00761761 .
-
-###24231777
-BACKGROUND	Rapid diagnosis and accurate detection of etiological agents in pyogenic spinal infection ( PSI ) patients are important .
-OBJECTIVE	The purpose of this study was to evaluate the clinical usefulness of methicillin-resistant Staphylococcus-specific polymerase chain reaction ( MRS-PCR ) and broad-range universal PCR ( U-PCR ) for diagnosing PSI .
-METHODS	A prospective diagnostic study .
-METHODS	Thirty-two clinically suspect PSI patients and six control patients who underwent computerized tomography-guided biopsy and/or surgical treatment were enrolled .
-METHODS	Tissue samples were examined by microbiological culture , histopathology , and real-time PCR ( MRS-PCR and U-PCR ) .
-METHODS	The diagnostic accuracy of real-time PCR was analyzed based on the definitive diagnosis of infection , defined as a positive result from microbiological culture or histopathology .
-RESULTS	All six control subjects were negative for PSI for all analyses .
-RESULTS	Twelve clinically suspect PSI subjects received definitive diagnoses ( PSI group ) .
-RESULTS	The non-PSI group consisted of six control subjects plus the remaining 20 patients from the PSI clinically suspect group .
-RESULTS	MRS-PCR results were positive for all MRS-cultured PSI subjects .
-RESULTS	U-PCR was positive for all subjects in the PSI group with one discrepancy between real-time PCR and microbiological culture results in differentiation between gram-positive and gram-negative bacteria .
-RESULTS	In the non-PSI group , MRS-PCR and U-PCR were positive in three and seven cases , respectively .
-RESULTS	The sensitivity , specificity , positive predictive value , and negative predictive value of MRS-PCR for diagnosing MRS infection were 1.00 , 0.91 , 0.57 , and 1.00 , respectively ; those for the diagnosis of bacterial infection with U-PCR were 1.00 , 0.73 , 0.63 , and 1.00 , respectively .
-CONCLUSIONS	Identification of MRS infection and ability to differentiate between gram-positive and gram-negative bacteria is rapidly achieved using MRS-PCR and U-PCR .
-CONCLUSIONS	Real-time PCR provides a sensitive molecular diagnosis of PSI and may contribute to antibiotic selection .
-
-###25636415
-OBJECTIVE	To evaluate radiation dose , image quality , and optimal level of sinogram-affirmed iterative reconstruction ( SAFIRE ) of cerebral CT angiography ( CTA ) at 70 kVp .
-METHODS	One hundred patients were prospectively classified into two groups : Group A ( n = 50 ) , 70 kVp cerebral CTA with 5 levels of SAFIRE reconstruction ( S1-S5 ) ; and Group B ( n = 50 ) , 120 kVp with filtered back projection ( FBP ) reconstruction .
-METHODS	CT attenuation values , noise , signal-to-noise ratio ( SNR ) and contrast-to-noise ratio ( CNR ) of the internal carotid artery ( ICA ) and middle cerebral artery ( MCA ) were measured .
-METHODS	Subjective image quality was evaluated .
-METHODS	Effective dose ( ED ) was estimated .
-RESULTS	CT attenuation and noise of the ICA and MCA in Group A were higher than those of Group B ( all P < 0.001 ) while the SNRICA , SNRMCA , CNRICA , and CNRMCA of Group A at S4-5 were comparable to ( P > 0.05 ) or higher than in Group B ( P < 0.05 ) .
-RESULTS	There was no difference in overall image quality between Group A S3-5 and Group B ( P > 0.05 ) .
-RESULTS	ED was 0.20.0 mSv for Group A with 85 % ED reduction in comparison to Group B ( 1.30.2 mSv ) .
-CONCLUSIONS	Cerebral CTA at 70 kVp is feasible , allowing for substantial radiation dose reduction .
-CONCLUSIONS	SAFIRE S4 level is recommended for obtaining optimal image quality .
-CONCLUSIONS	70 kVp cerebral CTA is feasible and provides diagnostic image quality .
-CONCLUSIONS	70 kVp cerebral CTA resulted in 85 % effective dose reduction .
-CONCLUSIONS	S4 level of SAFIRE is recommended for 70 kVp cerebral CTA .
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-###24518770
-OBJECTIVE	Relapse after cessation of desmopressin is an important problem in treating patients with enuresis .
-OBJECTIVE	Structured withdrawal of desmopressin tablets has been shown to decrease relapse rates .
-OBJECTIVE	However , scientific data are lacking onthe structured withdrawal of the fast melting oral formulation of desmopressin .
-OBJECTIVE	We compared relapse rates of structured withdrawal using placebo and direct cessation in a population of patients with enuresis who were desmopressin responders .
-METHODS	Patients diagnosed with enuresis and responding todesmopressin from 13 different centers were involved in the study .
-METHODS	Patients wererandomized into 4 groups .
-METHODS	Two different structured withdrawal strategies were compared to placebo and direct withdrawal .
-METHODS	Sample size was estimated as240 ( 60 patients in each group ) , with a power of 0.80 and an effect size of30 % .
-METHODS	Randomization was performed using NCSS statistical software ( NCSS , Kaysville , Utah ) from a single center .
-METHODS	The relapse rates of the groups were compared using chi-square testing .
-METHODS	Logistic regression analysis was performed todefine the independent factors having an effect onrelapse rates .
-RESULTS	Desmopressin treatment was initiated in 421 patients , and 259 patients were eligible for randomization .
-RESULTS	Relapse rates were 39 ( 1 % ) and 42 ( 4 % ) for the structured withdrawal groups , which were significantly less than for direct withdrawal ( 55 , 3 % ) and placebo ( 53 , 1 % ) .
-RESULTS	Logistic regression analysis revealed that initial effective dose of 240 cg , greater number of wet nights before treatment and nonstructured withdrawal were associated with higher relapse rates .
-CONCLUSIONS	We found that structured withdrawal with the fast melting oralformulation of desmopressin results in decreased relapse rates .
-CONCLUSIONS	Application of astructured withdrawal program was also an independent factor associated withreduced relapse rates , together with lower initial effective dose and number of wet nights per week .
-CONCLUSIONS	Relapse after cessation of desmopressin is an important problem , and in this study structured withdrawal was observed to be associated with decreased relapse rates compared to placebo and direct withdrawal .
-
-###25500293
-OBJECTIVE	The Cardiothoracic Surgical Trials Network recently reported no difference in the primary end point of left ventricular end-systolic volume index at 1 year postsurgery in patients randomized to repair ( n = 126 ) or replacement ( n = 125 ) for severe ischemic mitral regurgitation .
-OBJECTIVE	However , patients undergoing repair experienced significantly more recurrent mitral regurgitation than patients undergoing replacement ( 32.6 % vs 2.3 % ) .
-OBJECTIVE	We examined whether baseline echocardiographic and clinical characteristics could identify those who will develop moderate/severe recurrent mitral regurgitation or die .
-METHODS	Our analysis includes 116 patients who were randomized to and received mitral valve repair .
-METHODS	Logistic regression was used to estimate a model-based probability of recurrence or death from baseline factors .
-METHODS	Receiver operating characteristic curves were constructed from these estimated probabilities to determine classification cut-points maximizing accuracy of prediction based on sensitivity and specificity .
-RESULTS	Of the 116 patients , 6 received a replacement before leaving the operating room ; all other patients had mild or less mitral regurgitation on intraoperative echocardiogram after repair .
-RESULTS	During the 2-year follow-up period , 76 patients developed moderate/severe mitral regurgitation or died ( 53 mitral regurgitation recurrences , 13 mitral regurgitation recurrences and death , and 10 deaths ) .
-RESULTS	The mechanism for recurrent mitral regurgitation was largely mitral valve leaflet tethering .
-RESULTS	Our model ( including age , body mass index , sex , race , effective regurgitant orifice area , basal aneurysm/dyskinesis , New York Heart Association class , history of coronary artery bypass grafting , percutaneous coronary intervention , or ventricular arrhythmias ) yielded an area under the receiver operating characteristic curve of 0.82 .
-CONCLUSIONS	The model demonstrated good discrimination in identifying patients who will survive 2 years without recurrent mitral regurgitation after mitral valve repair .
-CONCLUSIONS	Although our results require validation , they offer a clinically relevant risk score for selection of surgical candidates for this procedure .
-
-###24313246
-OBJECTIVE	To examine the associations between post-traumatic stress disorder ( PTSD ) symptoms , stimulant use , and treatment outcomes among dually diagnosed women .
-METHODS	Participants were 141 women who participated in a multisite clinical trial of group treatments for PTSD and addictions .
-RESULTS	Generalized linear models indicated Seeking Safety ( SS ; a cognitive-behavioral intervention ) was significantly more effective than Women 's Health Education ( WHE ; a control group intervention ) in reducing stimulant use at follow-up among women who were heavy stimulant users at pre-treatment and who showed improvements in PTSD symptoms .
-RESULTS	There were no significant differences between the interventions among women who were light stimulant users at treatment entry .
-CONCLUSIONS	These findings suggest that integrated treatment of co-occurring PTSD and addictions may be more effective than general health education approaches for heavy stimulant users .
-CONCLUSIONS	Assessment of frequency of stimulant use among individuals with PTSD symptoms may inform treatment selection for this population .
-
-###26188849
-BACKGROUND	The prevention of central venous catheter ( CVC ) associated bloodstream infections ( CABSIs ) in paediatric oncology patients is essential .
-BACKGROUND	Ethanol locks can eliminate pathogens colonising CVCs and microbial resistance is rare .
-BACKGROUND	Aim of this study was to determine whether two hour 70 % ethanol locks can reduce CABSI in paediatric oncology patients .
-METHODS	We conducted a randomised , double blind , multi-centre trial in paediatric oncology patients ( 1-18 years ) with newly inserted CVCs .
-METHODS	Patients were randomly assigned to receive two hour ethanol locks ( 1.5 or 3 ml 70 % ) or heparin locks ( 1.5 or 3 ml 100 IU/ml ) , whenever it was needed to use the CVC , maximum frequency once weekly .
-METHODS	Primary outcomes were time to CABSI or death due to CABSI .
-RESULTS	We recruited 307 patients ( ethanol , n = 153 ; heparin , n = 154 ) .
-RESULTS	In the ethanol group , 16/153 ( 10 % ) patients developed a CABSI versus 29/154 ( 19 % ) in the heparin group .
-RESULTS	The incidence of CABSI was 0.77 / 1000 and 1.46 / 1000 catheter days respectively ( p = 0.039 ) .
-RESULTS	The number-needed-to-treat was 13 .
-RESULTS	No patients died of CABSI .
-RESULTS	In particular , Gram-positive CABSIs were reduced ( ethanol , n = 8 ; heparin , n = 21 ; p = 0.012 ) .
-RESULTS	Fewer CVCs were removed because of CABSI in the ethanol group ( p = 0.077 ) .
-RESULTS	The ethanol lock patients experienced significantly more transient symptoms compared to the heparin lock patients ( maximum grade 2 ) ( nausea , p = 0.030 ; taste alteration , p < 0.001 ; dizziness , p = 0.001 ; blushing , p < 0.001 ) , no suspected unexpected serious adverse reactions ( SUSAR ) occurred .
-CONCLUSIONS	This is the first randomised controlled trial to show that ethanol locks can prevent CABSI in paediatric oncology patients , in particular CABSI caused by Gram-positive bacteria .
-CONCLUSIONS	Implementation of ethanol locks in clinical practice should be considered .
-
-###25028096
-BACKGROUND	Diabetes may confer an increased risk for the cardiovascular health effects of particulate air pollution , but few human clinical studies of air pollution have included people with diabetes .
-BACKGROUND	Ultrafine particles ( UFP , 100 nm in diameter ) have been hypothesized to be an important component of particulate air pollution with regard to cardiovascular health effects .
-METHODS	17 never-smoker subjects 30-60 years of age , with stable type 2 diabetes but otherwise healthy , inhaled either filtered air ( 0-10 particles/cm3 ) or elemental carbon UFP ( ~ 107 particles/cm3 , ~ 50 ug/m3 , count median diameter 32 nm ) by mouthpiece , for 2 hours at rest , in a double-blind , randomized , crossover study design .
-METHODS	A digital 12-lead electrocardiogram ( ECG ) was recorded continuously for 48 hours , beginning 1 hour prior to exposure .
-RESULTS	Analysis of 5-minute segments of the ECG during quiet rest showed reduced high-frequency heart rate variability with UFP relative to air exposure ( p = 0.014 ) , paralleled by non-significant reductions in time-domain heart rate variability parameters .
-RESULTS	In the analysis of longer durations of the ECG , we found that UFP exposure increased the heart rate relative to air exposure .
-RESULTS	During the 21 - to 45-hour interval after exposure , the average heart rate increased approximately 8 beats per minute with UFP , compared to 5 beats per minute with air ( p = 0.045 ) .
-RESULTS	There were no UFP effects on cardiac rhythm or repolarization .
-CONCLUSIONS	Inhalation of elemental carbon ultrafine particles alters heart rate and heart rate variability in people with type 2 diabetes .
-CONCLUSIONS	Our findings suggest that effects may occur and persist hours after a single 2-hour exposure .
-
-###24320057
-BACKGROUND	The most common side-effect of ablative fractional skin resurfacing in Asians is post inflammatory hyperpigmentation ( PIH ) .
-BACKGROUND	Various attempts have been made to reduce the occurrence of PIH after laser treatment including sun avoidance , the use of preoperative and postoperative treatment regimens , and treatment using conservative energy settings and epidermal protection .
-OBJECTIVE	To determine whether the use of broad-spectrum sunscreen with anti-inflammatory agents starting on the first day after fractional CO2 laser skin resurfacing reduces the incidence of post laser PIH .
-METHODS	Thirty patients were treated with ablative fractional CO2 resurfacing on both sides of their faces at 10mJ and 10 % density .
-METHODS	Each subject was randomly treated on one side of the face with petrolatum ointment four times a day for the first week after laser treatment and on the other side of the face with petrolatum ointment four times a day plus broad-spectrum sunscreen with anti-inflammatory agents in the morning starting on the first day after laser treatment .
-METHODS	Transepidermal water loss was recorded at baseline and every day for 1week .
-METHODS	Melanin and erythema indexes were measured at baseline , 1 - , 2-week , 1 - , 2 - and at 3-month post treatment .
-RESULTS	Of the 30 patients involved in the study , 26 received the treatment and attended 1 - , 2-week , 1 - , 2 - and 3-month post-treatment visits .
-RESULTS	Four patients were withdrawn from the study because they could not attend every follow-up visit .
-RESULTS	There was no statistically significant difference in transepidermal water loss at baseline , immediately after laser treatment , or at the D1 to D7 follow-up visits .
-RESULTS	Erythema index had no significantly statistical difference at baseline , 1 - , 2 - and at 3-month after laser treatment .
-RESULTS	Furthermore , there was a statistically significant difference in melanin index at 1-week post laser treatment between both sides ( P = 0.001 ) .
-RESULTS	Melanin index at the 1-week follow-up visit on the side treated with broad-spectrum sunscreen with anti-inflammatory agents starting on the first day after laser treatment was significantly less than the control side .
-CONCLUSIONS	The use of broad-spectrum sunscreen with anti-inflammatory agents starting on the first day after ablative fractional skin resurfacing can decrease the incidence of PIH after laser treatment at 1-week postoperatively .
-
-###24919195
-OBJECTIVE	To prospectively evaluate image quality and radiation dose using a low-dose computed tomography angiography protocol and iterative image reconstruction for high-pitch dual-source CT-angiography ( DSCTA ) of the supraaortic arteries .
-METHODS	DSCTA was performed in 42 patients , using either 120 kVp tube voltage , 120 mAS tube current , 2.4 pitch and filtered back projection , or 100 kVp tube voltage , 100 mAs tube current , 3.2 pitch , and sinogram affirmed iterative reconstruction .
-METHODS	Measurements of vessel attenuation , of the contrast-to-noise ratio ( CNR ) and the signal-to-noise ratio ( SNR ) were performed to objectively evaluate image quality .
-METHODS	Two readers evaluated subjective image quality and image noise , using a four-point scale .
-METHODS	Effective dose was used to compare the differences in radiation dose .
-RESULTS	Low-dose protocol application showed significantly higher vessel opacification ( p = 0.013 ) , and non-significantly higher CNR and SNR values .
-RESULTS	There was no difference in the subjective image quality and image noise reading between the protocols .
-RESULTS	Effective dose was significantly lower using the low-dose protocol ( 1.29 0.21 mSv vs. 2.92 0.72 mSv ; p < 0.001 ) .
-CONCLUSIONS	The combined use of reduced tube voltage , reduced tube current , and iterative reconstruction reduces radiation dose by 55.4 % in high-pitch DSCTA of the supraaortic arteries without impairment of image quality .
-
-###25741158
-OBJECTIVE	To investigate the efficacy of premedication with pronase , a proteolytic enzyme , in improving image quality during magnifying endoscopy .
-METHODS	The study was of a blinded , randomized , prospective design .
-METHODS	Patients were assigned to groups administered oral premedication of either pronase and simethicone ( Group A ) or simethicone alone ( Group B ) .
-METHODS	First , the gastric mucosal visibility grade ( 1-4 ) was determined during conventional endoscopy , and then a magnifying endoscopic examination was conducted .
-METHODS	The quality of images obtained by magnifying endoscopy at the stomach and the esophagus was scored from 1 to 3 , with a lower score indicating better visibility .
-METHODS	The endoscopist used water flushes as needed to obtain satisfactory magnifying endoscopic views .
-METHODS	The main study outcomes were the visibility scores during magnifying endoscopy and the number of water flushes .
-RESULTS	A total of 144 patients were enrolled , and data from 143 patients ( M : F = 90:53 , mean age 57.5 years ) were analyzed .
-RESULTS	The visibility score was significantly higher in the stomach following premedication with pronase ( 73 % with a score of 1 in Group A vs 49 % in Group B , P < 0.05 ) , but there was no difference in the esophagus visibility scores ( 67 % with a score of 1 in Group A vs 58 % in Group B ) .
-RESULTS	Fewer water flushes [ mean 0.70.9 times ( range : 0-3 times ) in Group A vs 1.91.5 times ( range : 0-6 times ) in Group B , P < 0.05 ] in the pronase premedication group did not affect the endoscopic procedure times [ mean 766 s ( range : 647-866 s ) for Group A vs 760 s ( range : 678-854 s ) for Group B , P = 0.88 ] .
-RESULTS	The total gastric mucosal visibility score was also lower in Group A ( 4.91.5 vs 8.31.8 in Group B , P < 0.01 ) .
-CONCLUSIONS	The addition of pronase to simethicone premedication resulted in clearer images during magnifying endoscopy and reduced the need for water flushes .
-
-###24866022
-OBJECTIVE	Our study tested the hypothesis that sodium ( Na ) - selenite expression treatment can reduce oxidative stress and increase plasma antioxidants , whereas modulating white blood cell antigen expression in severe sepsis .
-OBJECTIVE	Selenite is a well known cofactor of glutathione peroxidases and other antioxidant enzymes ; therefore , one may expect an antioxidant effect of treatment .
-METHODS	We randomized 40 severe septic patients into treatment and control groups .
-METHODS	Treatment group ( n = 21 ) received 1000-g/2 hours Na-selenite load , followed by a 1000-g/die medication .
-METHODS	Oxidative stress markers , including malondialdehyde , maximal free radical production , and plasma antioxidants : free sulfhydryl groups , glutathione levels , and superoxide dismutase and catalase enzyme activity were measured .
-RESULTS	According to our results , the treatment regime successfully restored serum selenium levels .
-RESULTS	Treatment group developed a significant malondialdehyde increase by the fifth study day , whereas reactive oxygen species production decreased significantly .
-RESULTS	Reduced glutathione and plasma sulfhydryl groups showed no significant difference .
-RESULTS	Treatment group showed deteriorated expression of CD11a and slight increase of CD49d expression on monocytes throughout our study .
-CONCLUSIONS	Although our Na-selenite treatment regime successfully restored the selenium deficiency of severe septic patients , antioxidant and white blood cell antigen expression modulating effect of the therapy was not observed in our patient group .
-
-###24851039
-BACKGROUND	Renal colic is typically characterized by the sudden onset of severe pain radiating from the flank to the groin and its acute management in emergency departments essentially aims at rapid pain relief .
-BACKGROUND	Spasmofen ( ) is a brand of Amriya Pharmaceutical Industries in the form of rectal suppositories containing ketoprofen 100 mg and hyoscine butylbromide 10 mg .
-BACKGROUND	This combination is intended for the rapid relief of severe colicky pain in the renal system , hepatobiliary system , or gastrointestinal tract .
-BACKGROUND	This trial aims to compare a single-dose of Spasmofen rectal suppository to a single intravenous ( IV ) ketorolac tromethamine 30 mg/2 mL dose in patients with acute renal colic .
-METHODS	A total of 80 eligible consecutive patients presenting to the emergency departments of two medical centers with acute renal colic were included in the study .
-METHODS	Eligible patients who signed the informed consent were randomly assigned into two treatment groups : an experimental group ( Spasmofen group ) who received one Spasmofen rectal suppository plus an IV injection of 2 mL of normal saline solution ; and a control group ( ketorolac group ) who received one ketorolac 30 mg/2 mL ampoule IV plus one placebo suppository .
-METHODS	Treatment success , defined as a change in the verbal rating score from severe or moderate pain to none or mild at 60 minutes after the dose , was compared between groups using the chi-square/Fisher 's exact test .
-METHODS	Percentage reductions in visual pain analog scale ( VPAS ) scores at 15 and 60 minutes after the dose were compared between groups using the Z-test for proportions .
-RESULTS	Successful treatment at 60 minutes occurred in 35 of 40 ( 87.5 % ) of Spasmofen-treated patients and in 33 of 40 ( 82.5 % ) of ketorolac-treated patients .
-RESULTS	The difference was not statistically significant by Fisher 's exact test ( P = 0.755 ) .
-RESULTS	The mean percentage reduction of VPAS after 15 minutes was 61.82 % in the Spasmofen-treated group and 64.76 % in the ketorolac-treated group .
-RESULTS	The difference was also not statistically significant by the Z-test for proportions ( P = 0.795 ) .
-RESULTS	Sixty minutes after being treated , Spasmofen was associated with a statistically significant greater reduction in VPAS ( mean % reduction = 92.36 % ) than ketorolac ( 75.06 % ; P = 0.0466 ) .
-CONCLUSIONS	Single-dose Spasmofen rectal suppository might be a safe and effective first-aid treatment for the emergency department relief of acute renal colic .
-
-###24895062
-BACKGROUND	Iosimenol 340 injection is a new isotonic iodinated contrast medium for X-ray angiography .
-OBJECTIVE	To investigate the pharmacokinetics and biotransformation , tolerability , and safety of Iosimenol 340 in healthy human subjects .
-METHODS	Twenty-four subjects were enrolled and randomized to receive either Iosimenol 340 ( 0.5 , 1.5 or 3.0 mL/kg ) or placebo ( 0.9 % saline ) .
-METHODS	In each dosing group , six subjects received Iosimenol 340 and two subjects received placebo .
-METHODS	Safety was assessed by physical examination , vital signs , electrocardiography , and laboratory tests .
-METHODS	Adverse events were recorded throughout the study up to 14 days after dosing .
-METHODS	Blood samples were collected from 10 min before until 48 h after the start of dosing and urine samples were collected from 15 min before until 96 h after the start of dosing .
-METHODS	Iosimenol was quantified in plasma and urine by measuring iodine concentrations with X-ray fluorescence .
-METHODS	High-performance liquid chromatography was used to assess iosimenol biotransformation .
-RESULTS	Mean half-lives ( mean standard deviation [ SD ] ) of iosimenol were 0.17 0.08 h ( 10.2 4.8 min ) and 2.01 0.32 h for distribution and terminal elimination phases , respectively .
-RESULTS	The apparent volume of distribution was 0.27 0.05 L/kg , indicating distribution to the extracellular fluid volume .
-RESULTS	Iosimenol was excreted within 24 h without any sign of metabolic transformation .
-RESULTS	Thirty-two adverse events were observed in 14 subjects .
-RESULTS	All were mild or moderate , and were transient in nature .
-CONCLUSIONS	Iosimenol was not metabolized , had a distribution volume corresponding to the extracellular space , and was rapidly excreted through the kidneys by glomerular filtration .
-CONCLUSIONS	The area under the plasma concentration curve and the peak plasma concentration was proportional to dose , while clearance was independent of dose .
-CONCLUSIONS	Iosimenol 340 was well tolerated .
-
-###25317545
-OBJECTIVE	Myoclonic movements are common problems during induction of anaesthesia with etomidate .
-OBJECTIVE	The myoclonus occurring after etomidate administration may represent a form of seizure .
-OBJECTIVE	Agonistic modulation of the opiate receptor may reduce seizures , and butorphanol acts in such a manner .
-OBJECTIVE	The aim of this randomised , double-blind , placebo-controlled clinical trial was to test our hypothesis that pre-treatment with butorphanol might reduce the incidence and severity of myoclonus induced by etomidate .
-METHODS	Patients ( 108 ) with American Society of Anaesthesiologists physical status I or II were randomly assigned to one of two groups to receive either 0.015 mg/kg of butorphanol ( n = 54 ) or saline ( n = 54 ) intravenously .
-METHODS	At two minutes after infusion of butorphanol or saline , 0.3 mg/kg etomidate was given .
-METHODS	The occurrence and severity ( observational score of 0-3 ) of myoclonus was assessed during 2 minutes after administration of etomidate .
-METHODS	For each patient , blood pressure ( BP ) , saturation of peripheral oxygen ( SpO ) , and heart rate ( HR ) were measured .
-RESULTS	The incidence of myoclonus was significantly lower in Group Butorphanol than in Group Saline ( 13.0 % vs 79.6 % ; RR = 0.163 , 95 % CI : 0.081-0 .329 ; = 48.265 , p < 0.0001 ) .
-RESULTS	The severity levels of myoclonic movement were also significantly lower in Group Butorphanol than in Group Saline ( p < 0.0001 ) .
-RESULTS	Throughout the procedure , changes of BP , SpO , and HR did not differ between the groups .
-RESULTS	There were no problems with bradycardia or hypotension .
-CONCLUSIONS	Infusion of 0.015 mg/kg butorphanol 2 minutes before etomidate administration is effective for suppressing myoclonus induced by etomidate during induction of general anaesthesia .
-
-###25601623
-BACKGROUND	Depressive symptoms occur frequently in Dutch society .
-BACKGROUND	Recently a new method for treating depressive symptoms was introduced in the Netherlands .
-BACKGROUND	The method , known as ` multi-moment non-invasive neurostimulation ' ( MNNS ) , involves presenting patients with a series of photographs , each picture having a positive valence .
-BACKGROUND	The purpose of this method is to improve the mood of patients .
-BACKGROUND	So far , however , the method has not been thoroughly tested .
-OBJECTIVE	To conduct a pilot study designed to compare the effectiveness of MNNS pictures with pictures from the International Affective Pictures System ( IAPS ) by means of a double-blind randomised controlled trial .
-METHODS	Thirty-three patients with depressive symptoms were randomly assigned to two groups , one representing the experimental condition ( MNNS ) and the other the control condition ( IAPS ) .
-METHODS	Patients were treated for six weeks in one mood-inductive session per week .
-METHODS	The severity of the patients ' depressive symptoms was assessed before the mood-induction treatment began and again at one week and at three months after the final session .
-RESULTS	Each group showed a significant reduction in depressive symptoms .
-RESULTS	There were no significant differences between the MNNS condition and the control condition with regard to the reduction of depressive symptoms over time .
-CONCLUSIONS	There was a marked reduction in the depressive symptoms of the patients of both groups which had received short-term treatments involving the viewing of pictures with a positive valence .
-CONCLUSIONS	This reduction was still apparent three months after the treatment .
-CONCLUSIONS	The positive pictures presented in the MNNS method were found to be just as effective in reducing depressive symptoms as the positive pictures presented by the IAPS .
-
-###25679199
-BACKGROUND	Randomized studies examining the effect of training of mental health professionals in suicide prevention guidelines are scarce .
-BACKGROUND	We assessed whether professionals benefited from an e-learning supported Train-the-Trainer programme aimed at the application of the Dutch multidisciplinary suicide prevention guideline .
-METHODS	45 psychiatric departments from all over the Netherlands were clustered in pairs and randomized .
-METHODS	In the experimental condition , all of the staff of psychiatric departments was trained by peers with an e-learning supported Train-the-Trainer programme .
-METHODS	Guideline adherence of individual professionals was measured by means of the response to on-line video fragments .
-METHODS	Multilevel analyses were used to establish whether variation between conditions was due to differences between individual professionals or departments .
-RESULTS	Multilevel analysis showed that the intervention resulted in an improvement of individual professionals .
-RESULTS	At the 3 month follow-up , professionals who received the intervention showed greater guideline adherence , improved self-perceived knowledge and improved confidence as providers of care than professionals who were only exposed to traditional guideline dissemination .
-RESULTS	Subgroup analyses showed that improved guideline adherence was found among nurses but not among psychiatrists and psychologists .
-RESULTS	No significant effect of the intervention on team performance was found .
-CONCLUSIONS	The ICT environment in departments was often technically inadequate when displaying the video clips clip of the survey .
-CONCLUSIONS	This may have caused considerable drop-out and possibly introduced selection bias , as professionals who were strongly affiliated to the theme of the study might have been more likely to finish the study .
-CONCLUSIONS	Our results support the idea that an e-learning supported Train-the-Trainer programme is an effective strategy for implementing clinical guidelines and improving care for suicidal patients .
-BACKGROUND	Netherlands Trial Register ( NTR3092 www.trialregister.nl ) .
-
-###24958769
-BACKGROUND	Participation in falls prevention activities by older people following presentation to the emergency department ( ED ) with a fall is suboptimal .
-BACKGROUND	This randomised controlled trial ( RCT ) will test the RESPOND programme , an intervention designed to improve older persons ' participation in falls prevention activities through delivery of patient-centred education and behaviour change strategies .
-METHODS	A RCT at two tertiary referral EDs in Melbourne and Perth , Australia .
-METHODS	528 community-dwelling people aged 60-90years presenting to the ED with a fall and discharged home will be recruited .
-METHODS	People who require an interpreter or hands-on assistance to walk ; live in residential aged care or > 50km from the trial hospital ; have terminal illness , cognitive impairment , documented aggressive behaviour or a history of psychosis ; are receiving palliative care or are unable to use a telephone will be excluded .
-METHODS	Participants will be randomly allocated to the RESPOND intervention or standard care control group .
-METHODS	RESPOND incorporates ( 1 ) a home-based risk factor assessment ; ( 2 ) education , coaching , goal setting and follow-up telephone support for management of one or more of four risk factors with evidence of effective interventions and ( 3 ) healthcare provider communication and community linkage delivered over 6months .
-METHODS	Primary outcomes are falls and fall injuries per person-year .
-CONCLUSIONS	RESPOND builds on prior falls prevention learnings and aims to help individuals make guided decisions about how they will manage their falls risk .
-CONCLUSIONS	Patient-centred models have been successfully trialled in chronic and cardiovascular disease ; however , evidence to support this approach in falls prevention is limited .
-BACKGROUND	The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12614000336684 ) .
-
-###24974155
-BACKGROUND	Community-acquired pneumonia ( CAP ) is the third-leading infectious cause of death worldwide .
-BACKGROUND	The standard treatment of CAP has not changed for the past fifty years and its mortality and morbidity remain high despite adequate antimicrobial treatment .
-BACKGROUND	Systemic corticosteroids have anti-inflammatory effects and are therefore discussed as adjunct treatment for CAP .
-BACKGROUND	Available studies show controversial results , and the question about benefits and harms of adjunct corticosteroid therapy has not been conclusively resolved , particularly in the non-critical care setting .
-METHODS	This randomized multicenter study compares a treatment with 7days of prednisone 50mg with placebo in adult patients hospitalized with CAP independent of severity .
-METHODS	Patients are screened and enrolled within the first 36hours of presentation after written informed consent is obtained .
-METHODS	The primary endpoint will be time to clinical stability , which is assessed every 12hours during hospitalization .
-METHODS	Secondary endpoints will be , among others , all-cause mortality within 30 and 180days , ICU stay , duration of antibiotic treatment , disease activity scores , side effects and complications , value of adrenal function testing and prognostic hormonal and inflammatory biomarkers to predict outcome and treatment response to corticosteroids .
-METHODS	Eight hundred included patients will provide an 85 % power for the intention-to-treat analysis of the primary endpoint .
-CONCLUSIONS	This largest to date double-blind placebo-controlled multicenter trial investigates the effect of adjunct glucocorticoids in 800 patients with CAP requiring hospitalization .
-CONCLUSIONS	It aims to give conclusive answers about benefits and risks of corticosteroid treatment in CAP .
-CONCLUSIONS	The inclusion of less severe CAP patients will be expected to lead to a relatively low mortality rate and survival benefit might not be shown .
-CONCLUSIONS	However , our study has adequate power for the clinically relevant endpoint of clinical stability .
-CONCLUSIONS	Due to discontinuing glucocorticoids without tapering after seven days , we limit duration of glucocorticoid exposition , which may reduce possible side effects .
-BACKGROUND	7 September 2009 on ClinicalTrials.gov : NCT00973154 .
-
-###25302016
-BACKGROUND	KM-023 is a new second-generation nonnucleoside reverse-transcriptase inhibitor that is under development for the treatment of human immunodeficiency virus ( HIV ) type 1 infection .
-OBJECTIVE	This study determined KM-023 tolerability and pharmacokinetic characteristics in healthy subjects .
-METHODS	A randomized , double-blinded , placebo-controlled , dose-escalation study was conducted in 80 healthy South Korean male volunteers .
-METHODS	The subjects were allocated to single - or multiple-dose ( once daily for 7 days ) groups that received 75 , 150 , 300 , or 600 mg drug or placebo in a 4:1 ratio .
-METHODS	Safety and pharmacokinetic assessments were performed during the study .
-METHODS	Plasma and urine concentrations were quantified using liquid chromatography-tandem mass spectrometry .
-RESULTS	The average maximum concentration ( Cmax ) and area under the concentration-time curve from time 0 to infinity ( AUC ) values of KM-023 for the 75-600 mg doses in the single-dose study ranged from 440.2 ng/mL to 1,245.4 ng/mL and 11,142.4 ng h/mL to 33,705.6 ng h/mL , respectively .
-RESULTS	Values of the mean Cmax at a steady state and AUC within the dosing interval ranged from 385.1 ng/mL to 1,096.7 ng/mL and 3,698.9 ng h/mL to 10,232.6 ng h/mL , respectively , following 75-600 mg doses in the multiple-dose study .
-RESULTS	Dose proportionality was not observed for KM-023 .
-RESULTS	KM-023 showed a 0.6-fold accumulation after multiple doses in the 600 mg dose group .
-RESULTS	The mean half-life values ranged between 20.7 and 31.2 hours .
-RESULTS	KM-023 was generally well tolerated without serious adverse events .
-CONCLUSIONS	KM-023 demonstrated dose - and time-dependent nonlinear pharmacokinetic characteristics after single or multiple doses over a dose range ( 75-600 mg ) in healthy subjects .
-CONCLUSIONS	KM-023 showed favorable tolerability in this study .
-CONCLUSIONS	This Phase I clinical trial information can be used to design further clinical studies appropriately to evaluate KM-023 in patients with HIV-1 infection .
-
-###25689529
-OBJECTIVE	This trial assessed the efficacy of cotrimoxazole lock solution in reducing catheter-related blood stream infections ( CRBSIs ) among hemodialysis ( HD ) patients who were dialyzed using tunneled catheters .
-METHODS	Patients randomly received either heparin ( 2500 U/ml ) ( control group ) or a mixture of 10 mg/ml cotrimoxazole ( based on trimethoprim ) and 2500 U/ml heparin ( antibiotic group ) as catheters lock solution .
-RESULTS	Compared with the control group , CRBSIs rates per 1000 catheter-days was significantly lower ( 0.58 vs 4.4 events ; p = 0.002 ) and cumulative infection-free catheter survival was significantly higher ( log rank statistic 5.88 ; p = 0.015 ) in the antibiotic group .
-RESULTS	There were no statistical differences regarding incidences of catheter removal ( 8.7 % in the antibiotic group vs 22 % in the control group ; p = 0.116 ) or thrombosis ( 2.2 % in the antibiotic group vs 9.8 % in the control group ; p = 0.129 ) between the two groups .
-CONCLUSIONS	cotrimoxazole containing catheter lock solution is effective in reducing CRBSIs incidence and prolonging dialysis catheter survival in HD patients .
-
-###24220547
-BACKGROUND	There is increasing community and government recognition of the magnitude and impact of adolescent depression .
-BACKGROUND	Family based interventions have significant potential to address known risk factors for adolescent depression and could be an effective way of engaging adolescents in treatment .
-BACKGROUND	The evidence for family based treatments of adolescent depression is not well developed .
-BACKGROUND	The objective of this clinical trial is to determine whether a family based intervention can reduce rates of unipolar depressive disorders in adolescents , improve family functioning and engage adolescents who are reluctant to access mental health services .
-METHODS	The Family Options study will determine whether a manualized family based intervention designed to target both individual and family based factors in adolescent depression ( BEST MOOD ) will be more effective in reducing unipolar depressive disorders than an active ( standard practice ) control condition consisting of a parenting group using supportive techniques ( PAST ) .
-METHODS	The study is a multicenter effectiveness randomized controlled trial .
-METHODS	Both interventions are delivered in group format over eight weekly sessions , of two hours per session .
-METHODS	We will recruit 160 adolescents ( 12 to 18 years old ) and their families , randomized equally to each treatment condition .
-METHODS	Participants will be assessed at baseline , eight weeks and 20 weeks .
-METHODS	Assessment of eligibility and primary outcome will be conducted using the KID-SCID structured clinical interview via adolescent and parent self-report .
-METHODS	Assessments of family mental health , functioning and therapeutic processes will also be conducted .
-METHODS	Data will be analyzed using Multilevel Mixed Modeling accounting for time x treatment effects and random effects for group and family characteristics .
-METHODS	This trial is currently recruiting .
-METHODS	Challenges in design and implementation to-date are discussed .
-METHODS	These include diagnosis and differential diagnosis of mental disorders in the context of adolescent development , non-compliance of adolescents with requirements of assessment , questionnaire completion and treatment attendance , breaking randomization , and measuring the complexity of change in the context of a family-based intervention .
-BACKGROUND	Australia and New Zealand Clinical Trials Registry Title : engaging youth with high prevalence mental health problems using family based interventions ; number 12612000398808 .
-BACKGROUND	Prospectively registered on 10 April 2012 .
-
-###25139726
-BACKGROUND	Obesity is a leading risk factor for endometrial cancer ( EC ) , particularly Type I forms , which are increasing in the U.S. Although death rates from most cancers have been decreasing , overall mortality in EC is increasing in the U.S. EC survivors ' poor fitness combined with their surgical treatments may make weight loss particularly challenging .
-BACKGROUND	High intensity exercise increases neurotrophins and neurological reward via altered striatal dopamine in animals , and , in humans , chronic high intensity exercise enhances meal-induced satiety and may reduce hedonic eating .
-BACKGROUND	`` Assisted '' exercise , a mode of exercise whereby a patient 's voluntary exercise rate is augmented mechanically , may modulate brain dopamine levels in Parkinson 's Disease patients but has not been previously evaluated as a treatment for obesity .
-METHODS	We describe the rationale and design of the REWARD trial , which has the overarching goal of randomizing 120 obese EC survivors to `` assisted '' or voluntary rate cycling to evaluate the efficacy of `` assisted '' exercise in enhancing and sustaining weight loss .
-METHODS	Patients in both arms will receive 3 days/week of supervised exercise and 1 day/week of a group dietary behavioral intervention for 16 weeks and , then , will be followed for 6 months .
-RESULTS	The primary outcome is weight loss .
-RESULTS	Secondary outcomes include measures for body composition , fitness , eating behavior , exercise motivation and , quality of life as well as cognition and food reward and motivation as assessed by functional magnetic resonance imaging ( fMRI ) tasks .
-CONCLUSIONS	If successful , the REWARD program could be extended to help sustain weight loss in obese cancer and non-cancer patients .
-
-###24338799
-OBJECTIVE	The objective of this study is to evaluate the effectiveness of a simple dyadic ( person with dementia and their main carer ) exercise regimen as a therapy for the behavioural and psychological symptoms of dementia .
-METHODS	A two arm , pragmatic , randomised , controlled , single-blind , parallel-group trial of a dyadic exercise regimen ( individually tailored walking regimen designed to become progressively intensive and last between 20-30min , at least five times per week ) .
-METHODS	Community-dwelling individuals with ICD-10 confirmed dementia with the following : clinically significant behavioural and psychological symptoms , a carer willing and able to co-participate in the exercise regimen , and no physical conditions or symptoms that would preclude exercise participation were invited by mental health or primary care services into the study .
-RESULTS	One hundred and thirty-one dyads were recruited to this study .
-RESULTS	There was no significant difference in Behavioural and Psychological Symptoms as measured by the Neuropsychiatric Inventory at week 12 between the group receiving the dyadic exercise regimen and those that did not ( adjusted difference in means ( intervention minus control ) = -1.53 , p = 0.6 , 95 % CI [ -7.37 , 4.32 ] ) .
-RESULTS	There was a significant between-group difference in caregiver 's burden as measured by the Zarit Caregiver Burden Inventory at week 12 ( OR = 0.18 , p = 0.01 , CI [ 0.05 , 0.69 ] ) favouring the exercise group .
-CONCLUSIONS	This study found that regular simple exercise does not appear to improve the behavioural and psychological symptoms of dementia , but did seem to attenuate caregiver burden .
-CONCLUSIONS	Further study to improve exercise uptake are needed .
-
-###25972527
-BACKGROUND	Consumption of flavonoid-rich foods such as cocoa and tea may reduce cardiovascular disease risk .
-BACKGROUND	The flavonoids epicatechin ( in cocoa and tea ) and quercetin ( in tea ) probably play a role by reducing endothelial dysfunction and inflammation , 2 main determinants of atherosclerosis .
-OBJECTIVE	We studied the effects of supplementation of pure epicatechin and quercetin on biomarkers of endothelial dysfunction and inflammation .
-METHODS	Thirty-seven apparently healthy ( pre ) hypertensive men and women ( 40-80 y ) participated in a randomized , double-blind , placebo-controlled crossover trial .
-METHODS	Participants ingested ( - ) - epicatechin ( 100 mg/d ) , quercetin-3-glucoside ( 160 mg/d ) , or placebo capsules for a period of 4 wk , in random order .
-METHODS	Plasma biomarkers of endothelial dysfunction and inflammation were measured at the start and end of each 4-wk intervention period .
-METHODS	The differences in changes over time between the intervention and placebo periods ( intervention - placebo ) were calculated and tested with a linear mixed model for repeated measures .
-RESULTS	Epicatechin changed epicatechin - placebo for soluble endothelial selectin ( sE-selectin ) by -7.7 ng/mL ( 95 % CI : -14.5 , -0.83 ; P = 0.03 ) but did not significantly change this difference ( -0.30 ; 95 % CI : -0.61 , 0.01 ; P = 0.06 ) for the z score for endothelial dysfunction .
-RESULTS	Quercetin changed quercetin - placebo for sE-selectin by -7.4 ng/mL ( 95 % CI : -14.3 , -0.56 ; P = 0.03 ) , that for IL-1 by -0.23 pg/mL ( 95 % CI : -0.40 , -0.06 ; P = 0.009 ) , and that for the z score for inflammation by -0.33 ( 95 % CI : -0.60 , -0.05 ; P = 0.02 ) .
-CONCLUSIONS	In ( pre ) hypertensive men and women , epicatechin may contribute to the cardioprotective effects of cocoa and tea through improvements in endothelial function .
-CONCLUSIONS	Quercetin may contribute to the cardioprotective effects of tea possibly by improving endothelial function and reducing inflammation .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01691404 .
-
-###24265770
-BACKGROUND	Muscle passive contraction of lower limb by neuromuscular electrostimulation ( NMES ) is frequently used in chronic heart failure ( CHF ) patients but no data are available concerning its action on sympathetic activity .
-BACKGROUND	However , Transcutaneous Electrical Nerve Stimulation ( TENS ) is able to improve baroreflex in CHF .
-BACKGROUND	The primary aim of the present study was to investigate the acute effect of TENS and NMES compared to Sham stimulation on sympathetic overactivity as assessed by Muscle Sympathetic Nerve Activity ( MSNA ) .
-METHODS	We performed a serie of two parallel , randomized , double blinded and sham controlled protocols in twenty-two CHF patients in New York Heart Association ( NYHA ) Class III .
-METHODS	Half of them performed stimulation by TENS , and the others tested NMES .
-RESULTS	Compare to Sham stimulation , both TENS and NMES are able to reduce MSNA ( 63.5 3.5 vs 69.7 3.1 bursts / min , p < 0.01 after TENS and 51.6 3.3 vs 56.7 3.3 bursts / min , p < 0 , 01 after NMES ) .
-RESULTS	No variation of blood pressure , heart rate or respiratory parameters was observed after stimulation .
-CONCLUSIONS	The results suggest that sensory stimulation of lower limbs by electrical device , either TENS or NMES , could inhibit sympathetic outflow directed to legs in CHF patients .
-CONCLUSIONS	These properties could benefits CHF patients and pave the way for a new non-pharmacological approach of CHF .
-
-###24610399
-BACKGROUND	Although the majority of smokers are ambivalent about quitting , few treatments specifically target smokers lacking motivation to quit in the near future .
-BACKGROUND	Most existing interventions are instead predicated on the belief that active treatments should only be distributed to smokers interested in quitting , a largely untested assumption .
-METHODS	In the current clinical trial ( N = 157 ) , motivated smokers wanting to quit in the next 30 days were given a 2-week nicotine replacement therapy ( NRT ) sample and a referral to a quitline ( Group MNQ ) , while unmotivated smokers were randomized to receive the same treatment ( Group UNQ ) or a quitline referral only ( Group UQ ) .
-METHODS	Participants were tracked via telephone for 3 months to assess quitting behaviors and smoking reduction .
-RESULTS	Groups significantly differed across all comparisons with regard to incidence of any quit attempt ( MNQ : 77 % , UNQ : 40 % , UQ : 18 % , p < .05 ) and any 24-hr quit attempts ( 62 % , 32 % , 16 % , p < .05 ) .
-RESULTS	Clinically meaningful differences emerged in the rates of floating ( 19 % , 17 % , 6 % ) and point prevalence abstinence ( 17 % , 15 % , 5 % ) .
-RESULTS	Compared to participants in Group UQ ( 11 % ) , a greater proportion of participants in Group MNQ ( 48 % , p = .01 ) and Group UNQ ( 31 % , p = .01 ) reduced their daily cigarette consumption by at least half .
-RESULTS	Proxy measures of cessation readiness ( e.g. , motivation ) favored participants receiving active forms of treatment .
-CONCLUSIONS	Providing NRT samples engaged both motivated and unmotivated smokers into the quitting process and produced positive changes in smoking outcomes .
-CONCLUSIONS	This suggests that motivation should not be considered a necessary precondition to receiving treatment .
-
-###24667662
-BACKGROUND	Emerging antimalarial drug resistance in mobile populations remains a significant public health concern .
-BACKGROUND	We compared two regimens of dihydroartemisinin-piperaquine in military and civilians on the Thai-Cambodian border to evaluate national treatment policy .
-METHODS	Efficacy and safety of two and three-day regimens of dihydroartemisinin-piperaquine were compared as a nested open-label evaluation within a malaria cohort study in 222 otherwise healthy volunteers ( 18 % malaria-infected at baseline ) .
-METHODS	The first 80 volunteers with slide-confirmed Plasmodium falciparum or vivax malaria were randomized 1:1 to receive either regimen ( total dose 360 mg dihydroartemisinin and 2880 mg piperaquine ) and followed weekly for up to 6 months .
-METHODS	The primary endpoint was malaria recurrence by day 42 .
-METHODS	Volunteers with vivax infection received primaquine at study discharge with six months follow-up .
-RESULTS	Eighty patients ( 60 vivax , 15 falciparum , and 5 mixed ) were randomized to dihydroartemisinin-piperaquine .
-RESULTS	Intention-to-treat all-species efficacy at Day 42 was 85 % for the two-day regimen ( 95 % CI 69-94 ) and 90 % for the three-day regimen ( 95 % CI 75-97 ) .
-RESULTS	PCR-adjusted falciparum efficacy was 75 % in both groups with nearly half ( 45 % ) still parasitemic at Day 3 .
-RESULTS	Plasma piperaquine levels were comparable to prior published reports , but on the day of recrudescence were below measurable in vitro piperaquine IC50 levels in all falciparum treatment failures .
-CONCLUSIONS	In the brief period since introduction of dihydroartemisinin-piperaquine , there is early evidence suggesting declining efficacy relative to previous reports .
-CONCLUSIONS	Parasite IC50 levels in excess of plasma piperaquine levels seen only in treatment failures raises concern for clinically significant piperaquine resistance in Cambodia .
-CONCLUSIONS	These findings warrant improved monitoring of clinical outcomes and follow-up , given few available alternative drugs .
-BACKGROUND	ClinicalTrials.gov NCT01280162 .
-
-###24322569
-OBJECTIVE	Screening for lung cancer has the potential to reduce mortality , but in addition to detecting aggressive tumors , screening will also detect indolent tumors that otherwise may not cause clinical symptoms .
-OBJECTIVE	These overdiagnosis cases represent an important potential harm of screening because they incur additional cost , anxiety , and morbidity associated with cancer treatment .
-OBJECTIVE	To estimate overdiagnosis in the National Lung Screening Trial ( NLST ) .
-METHODS	We used data from the NLST , a randomized trial comparing screening using low-dose computed tomography ( LDCT ) vs chest radiography ( CXR ) among 53452 persons at high risk for lung cancer observed for 6.4 years , to estimate the excess number of lung cancers in the LDCT arm of the NLST compared with the CXR arm .
-METHODS	We calculated 2 measures of overdiagnosis : the probability that a lung cancer detected by screening with LDCT is an overdiagnosis ( PS ) , defined as the excess lung cancers detected by LDCT divided by all lung cancers detected by screening in the LDCT arm ; and the number of cases that were considered overdiagnosis relative to the number of persons needed to screen to prevent 1 death from lung cancer .
-RESULTS	During follow-up , 1089 lung cancers were reported in the LDCT arm and 969 in the CXR arm of the NLST .
-RESULTS	The probability is 18.5 % ( 95 % CI , 5.4 % -30.6 % ) that any lung cancer detected by screening with LDCT was an overdiagnosis , 22.5 % ( 95 % CI , 9.7 % -34.3 % ) that a non-small cell lung cancer detected by LDCT was an overdiagnosis , and 78.9 % ( 95 % CI , 62.2 % -93.5 % ) that a bronchioalveolar lung cancer detected by LDCT was an overdiagnosis .
-RESULTS	The number of cases of overdiagnosis found among the 320 participants who would need to be screened in the NLST to prevent 1 death from lung cancer was 1.38 .
-CONCLUSIONS	More than 18 % of all lung cancers detected by LDCT in the NLST seem to be indolent , and overdiagnosis should be considered when describing the risks of LDCT screening for lung cancer .
-
-###25418542
-OBJECTIVE	The portion size of food is a determinant of energy intake , linking with obese traits .
-OBJECTIVE	A healthy plate for portion control has recently been made in a Japanese style .
-OBJECTIVE	The aim of the current study was to assess the efficacy of a lifestyle intervention program using the Japanese-style healthy plate on weight reduction in overweight and obese diabetic Japanese subjects .
-METHODS	We randomized overweight and obese diabetic subjects ( n = 19 , 10 women ) into an intervention group including educational classes on lifestyle modification incorporating the healthy plate ( n = 10 ) or a waiting-list control group ( n = 9 ) .
-METHODS	The intervention period was three months , and the educational classes using the healthy plate were conducted monthly in a group session for the intervention group .
-METHODS	The body weight , blood glycemic and metabolic measures , and psychosocial variables were measured at the baseline and after the 3-month intervention in both groups .
-METHODS	The impression of the intervention was interviewed using a structured questionnaire .
-RESULTS	There was one drop-out in the control group .
-RESULTS	No adverse events were reported in the groups .
-RESULTS	Subjects in the intervention group had a greater weight change from baseline to the end of the 3-month intervention period ( -3.7 + / - 2.5 [ SD ] kg in the intervention group vs. -0.1 + / - 1.4 kg in the control group , P = 0.002 ) .
-RESULTS	Most subjects recorded that the use of a healthy plate could be recommended to other people .
-CONCLUSIONS	The lifestyle intervention program using the Japanese-style healthy plate , which was developed for portion control , may effectively reduce body weight in overweight and obese diabetic subjects in Japan .
-CONCLUSIONS	Further studies are needed to establish the efficacy of this methodology on weight management .
-
-###25409961
-BACKGROUND	In surgical procedures , obesity is a risk factor for the onset of intra and postoperative respiratory complications .
-OBJECTIVE	Determine what moment of application of positive pressure brings better benefits on lung function , incidence of atelectasis and diaphragmatic excursion , in the preoperative , intraoperative or immediate postoperative period .
-METHODS	Randomized , controlled , blinded study , conducted in a hospital and included subjects with BMI between 40 and 55 kg/m2 , 25 and 55 years , underwent bariatric surgery by laparotomy .
-METHODS	They were underwent preoperative and postoperative evaluations .
-METHODS	They were allocated into four different groups : 1 ) Gpre : treated with positive pressure in the BiPAP mode ( Bi-Level Positive Airway Pressure ) before surgery for one hour ; 2 ) Gpos : BIPAP after surgery for one hour ; 3 ) Gintra : PEEP ( Positive End Expiratory Pressure ) at 10 cmH2O during the surgery ; 4 ) Gcontrol : only conventional respiratory physiotherapy .
-METHODS	The evaluation consisted of anthropometric data , pulmonary function tests and chest radiography .
-RESULTS	Were allocated 40 patients , 10 in each group .
-RESULTS	There were significant differences for the expiratory reserve volume and percentage of the predicted expiratory reserve volume , in which the groups that received treatment showed a smaller loss in expiratory reserve volume from the preoperative to postoperative stages .
-RESULTS	The postoperative radiographic analysis showed a 25 % prevalence of atelectasis for Gcontrol , 11.1 % for Gintra , 10 % for Gpre , and 0 % for Gpos .
-RESULTS	There was no significant difference in diaphragmatic mobility amongst the groups .
-CONCLUSIONS	The optimal time of application of positive pressure is in the immediate postoperative period , immediately after extubation , because it reduces the incidence of atelectasis and there is reduction of loss of expiratory reserve volume .
-
-###26178727
-BACKGROUND	Biomarkers of micronutrient status are needed to best define deficiencies and excesses of essential nutrients .
-OBJECTIVE	We evaluated several supporting biomarkers of vitamin A status in Zambian children to determine whether any of the biomarkers were consistent with high liver retinol stores determined by using retinol isotope dilution ( RID ) .
-METHODS	A randomized , placebo-controlled , biofortified maize efficacy trial was conducted in 140 rural Zambian children from 4 villages .
-METHODS	A series of biomarkers were investigated to better define the vitamin A status of these children .
-METHODS	In addition to the assessment of total-body retinol stores ( TBSs ) by using RID , tests included analyses of serum carotenoids , retinyl esters , and pyridoxal-5 ' - phosphate ( PLP ) by using high-pressure liquid chromatography , retinol-binding protein by using ELISA , and alanine aminotransferase ( ALT ) activity by using a colorimetric assay .
-RESULTS	Children ( n = 133 ) were analyzed quantitatively for TBSs by using RID .
-RESULTS	TBSs , retinyl esters , some carotenoids , and PLP differed by village site .
-RESULTS	Serum carotenoids were elevated above most nonintervened reference values for children .
-RESULTS	- Carotene , - carotene , and lutein values were > 95th percentile from children in the US NHANES III , and 13 % of children had hypercarotenemia ( defined as total carotenoid concentration > 3.7 mol/L ) .
-RESULTS	Although only 2 % of children had serum retinyl esters > 10 % of total retinol plus retinyl esters , 16 % of children had > 5 % as esters , which was consistent with high liver retinol stores .
-RESULTS	Ratios of serum retinol to retinol-binding protein did not deviate from 1.0 , which indicated full saturation .
-RESULTS	ALT activity was low , which was likely due to underlying vitamin B-6 deficiency , which was confirmed by very low serum PLP concentrations .
-CONCLUSIONS	The finding of hypervitaminosis A in Zambian children was supported by high circulating concentrations of carotenoids and mildly elevated serum retinyl esters .
-CONCLUSIONS	ALT-activity assays may be compromised with co-existing vitamin B-6 deficiency .
-CONCLUSIONS	Nutrition education to improve intakes of whole grains and animal-source foods may enhance vitamin B-6 status in Zambians .
-
-###25372452
-BACKGROUND	Surgical site infection ( SSI ) is the second most common type of nosocomial infections in the United States .
-BACKGROUND	In Uruguay , the incidence after prostatectomies is 2.6 % .
-BACKGROUND	The aim of our study was to compare the efficacy of two skin antiseptics and to determine possible risk factors for SSI in patients undergoing surgery for benign prostatic hyperplasia ( BPH ) .
-METHODS	A randomized trial included 70 patients operated on for BPH , of whom 56 ( 80 % ) underwent open surgery .
-METHODS	Patients were treated by the same surgical team in a tertiary general hospital that is a referral center for patients with urologic diseases .
-METHODS	Skin antisepsis was performed randomly using either 0.5 % povidone-iodine or chlorhexidine in an alcohol base ( Chemisol ( ) ) .
-METHODS	Possible risk factors investigated were age , renal dysfunction , bladder stones , preoperative urinary catheter , positive preoperative urine culture , operative time and technique , and vesicocutaneous fistula .
-RESULTS	Of all patients , 41 ( 59 % ) had a urinary catheter preoperatively .
-RESULTS	Urine cultures were positive in 31 patients , of whom 29 ( 94 % ) had a urinary catheter .
-RESULTS	Surgical site infection occurred in 10 patients ( 18 % ) , and 100 % of the causative microorganisms were gram-negative bacteria characteristic of the urinary flora .
-RESULTS	The type of antiseptic did not affect the risk of SSI ( p = 1.00 ) .
-RESULTS	The most important risk factor for infection was the presence of a urinary catheter preoperatively ( p = 0.003 ) ; also significant were the formation of a vesicocutaneous fistula ( p = 0.008 ) , increasing age ( p = 0.02 ) , and the presence of a positive preoperative urine culture ( p = 0.03 ) .
-CONCLUSIONS	In a cohort of patients submitted to open prostatectomy , SSI was not related to the type of antiseptic .
-CONCLUSIONS	The main risk factor was the presence of a urinary catheter preoperatively .
-CONCLUSIONS	All microorganisms isolated from the SSIs were characteristic of urinary tract infections .
-
-###25356623
-OBJECTIVE	To evaluate the conception rate to fixed-time artificial insemination ( FTAI ) of two oestrus synchronisation programmes in dairy heifers on eight farms over 2 years .
-METHODS	The study was conducted in 2008 and 2010 on eight farms near Palmerston North , New Zealand .
-METHODS	Nulliparous Friesian and FriesianJersey heifers ( 13-15 months of age ) were randomly allocated to one of two oestrus synchronisation programmes .
-METHODS	Group 1 ( GPG+P 4 ; n = 330 ) , received gonadotrophin-releasing hormone ( GnRH ) I/M on Day 0 , a progesterone ( P4 ) - releasing intravaginal device from Days 0-7 , prostaglandin F2 ( PGF ) I/M on Day 7 and a second dose of GnRH at the time of FTAI on Day 9 .
-METHODS	The second group ( P4 + PGF ; n = 343 ) received a P4-releasing intravaginal device from Days 0-7 , PGF on Day 6 and FTAI on Day 9 .
-METHODS	Pregnancy was diagnosed from Days 42-52 by transrectal ultrasonography .
-RESULTS	The overall conception rate was 52.4 % and 54.8 % for the GPG+P 4 and P4 + PGF groups , respectively .
-RESULTS	The odds of conception for the two treatments were not different ( OR = 0.90 ; 95 % CI = 0.67-1 .23 ) , nor was there any difference between groups in different years ( p = 0.58 ) .
-RESULTS	Farm affected conception rate ( p = 0.002 ) , but there was no interaction with treatment ( p = 0.92 ) .
-CONCLUSIONS	This study has shown that an alternative synchronisation programme can produce similar results in terms of conception rate to the GPG+P 4 treatment , currently commonly used in heifers .
-CONCLUSIONS	More research is required to establish whether other modifications to the GPG+P 4 programme can produce similar results at lower costs , and to identify and quantify farm factors which affect the economic benefit of heifer synchronisation .
-CONCLUSIONS	This study indicated that synchronising heifers with P4 and PGF resulted in conception rates equivalent to those resulting from a GPG+P 4 treatment , but with reduced drug costs .
-CONCLUSIONS	However , because heifers in the GPG+P 4 group received the second GnRH injection at the time of AI , they needed only three yardings as opposed to the four required for the heifers treated with P4 and PGF .
-CONCLUSIONS	Thus , the choice of programme for an individual farm will depend on that farm 's circumstances , in particular the cost of yarding the heifers .
-
-###25688740
-BACKGROUND	Efficacy and safety are the two considerations when characterising the effects of a new therapy .
-BACKGROUND	We sought to apply an innovative method of assessing the benefit-risk balance using data from a completed randomised controlled trial that compared erlotinib vs placebo added to gemcitabine in patients with advanced pancreatic cancer ( NCIC CTG PA. 3 ) .
-METHODS	We applied generalised pairwise comparisons with several prioritised outcome measures ( e.g. , one or more benefit outcomes and one or more risk outcomes ) .
-METHODS	Here , the first priority outcome was overall survival ( OS ) time .
-METHODS	Differences in OS that exceeded 2 months were considered clinically meaningful .
-METHODS	The second priority outcome was toxicity .
-METHODS	The overall treatment effect was quantified using the proportion in favour of erlotinib , which can be interpreted as the net proportion of patients who have a better overall outcome with erlotinib as compared with placebo .
-METHODS	Sensitivity analyses were performed .
-RESULTS	In this trial 569 patients were randomly assigned in a 1:1 ratio to receive gemcitabine plus either erlotinib or a matched placebo .
-RESULTS	Overall , the method indicated no statistically significant overall treatment effect in favour of erlotinib ; if anything , the point estimate of the net proportion leaned in favour of the placebo group ( overall proportion in favour of erlotinib = -3.6 % , 95 % CI , -14.2 - 7.1 % ; P = 0.51 ) .
-RESULTS	The net proportion was never in favour of the erlotinib group throughout all sensitivity analyses .
-CONCLUSIONS	Generalised pairwise comparisons make it possible to assess the benefit-risk balance of new treatments using a single statistical test for any number of prioritised outcomes .
-CONCLUSIONS	The benefit-risk assessment was not in favour of adding erlotinib to gemcitabine for the treatment of patients with advanced pancreatic cancer .
-
-###25471688
-BACKGROUND	Sedation using intranasal dexmedetomidine is a convenient and well-tolerated technique .
-BACKGROUND	This study evaluated the sedative efficacy of intranasal dexmedetomidine in combination with patient-controlled sedation ( PCS ) for upper gastrointestinal endoscopy .
-METHODS	In this double-blind , randomised , controlled trial , 50 patients received either intranasal dexmedetomidine 1.5 g/kg ( dexmedetomidine group ) or intranasal saline ( placebo group ) 1h before the procedure .
-METHODS	PCS with propofol and alfentanil was provided for rescue sedation .
-METHODS	Additional sedative consumption , perioperative sedation scores using Observer 's Assessment of Alertness/Sedation ( OAA/S ) scale , recovery , vital signs , adverse events and patient satisfaction were assessed .
-RESULTS	Total consumption of PCS propofol and alfentanil was significantly less in the dexmedetomidine than placebo group with a mean difference of -13.8 mg propofol ( 95 % confidence interval -27.3 to -0.3 ) and -34.5 g alfentanil ( 95 % confidence interval -68.2 to -0.7 ) at the completion of the procedure ( P = 0.044 ) .
-RESULTS	Weighted areas under the curve ( AUCw ) of OAA/S scores were significantly lower in the dexmedetomidine group before , during and after procedures ( P < 0.001 , P = 0.024 and P = 0.041 respectively ) .
-RESULTS	AUCw of heart rate and systolic blood pressure were also significantly lower during the procedure ( P = 0.007 and P = 0.022 respectively ) with dexmedetomidine .
-RESULTS	There was no difference in recovery , side effects or satisfaction .
-CONCLUSIONS	Intranasal dexmedetomidine with PCS propofol and alfentanil confers deeper perioperative clinical sedation with significantly less use of additional sedatives during upper gastrointestinal endoscopy .
-
-###25475143
-BACKGROUND	This split-mouth , double-blind randomized controlled trial evaluated radiographic changes in infrabony defects treated with open flap debridement ( OFD ) or OFD associated with enamel matrix derivative ( EMD ) after a 24-month follow-up .
-BACKGROUND	The radiographic distance from the CEJ to the bottom of the defect ( BD ) was considered the primary outcome .
-BACKGROUND	CEJ-BC and defect angle were secondary outcomes .
-METHODS	Ten patients presenting 2 or more defects were selected .
-METHODS	An individualized film holder was used to take standardized radiographs of the 43 defects , at baseline and after 24months .
-METHODS	Images were digitized and used to measure the distances from the cemento-enamel junction ( CEJ ) to the alveolar crest ( AC ) , CEJ to the bottom of the defect ( BD ) and infrabony defect angle .
-METHODS	Statistical analysis was performed in SPSS for Windows ( version 5.2 ) .
-METHODS	Paired samples t test was used to compare test and control groups and to evaluate changes within each group .
-METHODS	The level of significance was set at = 0.05 % .
-RESULTS	After 24months , a significant crestal bone loss was observed for EMD ( 1.01 mm ; p = 0.049 ) but not for OFD ( 0.14 mm ; p = 0.622 ) .
-RESULTS	However , no differences were detected between groups ( p = 0.37 ) .
-RESULTS	Reduction of the bone defect depth was significant for OFD ( 0.70 mm ; p = 0.005 ) but not for EMD ( 0.04 mm ; p = 0.86 ) , while no differences were detected between them ( p = 0.87 ) .
-RESULTS	Both EMD ( 0.69 ; p = 0.82 ) and OFD ( 5.71 ; p = 0.24 ) showed an improvement in defect angle measurements but no significant differences were observed after 24months or between the groups ( p = 0.35 ) .
-CONCLUSIONS	Linear radiographic analysis was not able to demonstrate superiority of EMD treated infrabony defects when compared to ODF after 24months .
-BACKGROUND	ClinicalTrials.gov : NCT02195765 .
-BACKGROUND	Registered 17 July 2014 .
-
-###24475826
-OBJECTIVE	To develop a mathematical model to adjust the timing of computed tomography ( CT ) scans with the hazard of cancer recurrence in time to facilitate early detection of cancer recurrence .
-METHODS	The clinical data were extracted from the randomized Scandinavian Sarcoma Group ( SSG ) XVIII/Arbeitsgemeinschaft Internistische Onkologie ( AIO ) trial database .
-METHODS	The SSG XVIII/AIO trial was registered ( trial no .
-METHODS	NCT00116935 ) and approved by the national or institutional review boards .
-METHODS	In the trial , 1 - and 3-year durations of adjuvant imatinib mesylate in the treatment of patients with gastrointestinal stromal tumor ( GIST ) were compared .
-METHODS	A nonhomogeneous Poisson model with a piecewise log-constant hazard in time that accounts for the nonlinear pattern of GIST recurrence was applied to tumor site , mitotic count , and recurrence data .
-METHODS	The optimal times to obtain follow-up CT scans were computed by modifying the frequency of CT scans with the hazard of tumor recurrence in time .
-METHODS	The hazard-adjusted follow-up schedules were compared with the National Comprehensive Cancer Network ( NCCN ) guidelines of the United States , which suggest imaging with CT at intervals of 3-6 months for 3-5 years and then annually .
-RESULTS	Optimized timing of CT scans on the basis of hazard of recurrence resulted in follow-up schedule options where CT is performed more sparsely than in the NCCN guidelines during adjuvant imatinib administration and more frequently , at approximately 3-month intervals , during the first 2 years that follow imatinib discontinuation when the risk of recurrence was the greatest .
-RESULTS	The number of CT scans could be reduced by a median of 31 % ( from 13 to nine ) compared with the standard schedules within the first 6 years of follow-up without increasing the delay in recurrence detection .
-CONCLUSIONS	Detection of GIST recurrence may be enhanced by adjusting the timing of the CT scans with the hazard of recurrence .
-CONCLUSIONS	The method may be applicable to other human tumor types .
-CONCLUSIONS	Online supplemental material is available for this article .
-
-###24905206
-BACKGROUND	In the field of intelligence research , it has been shown that some people conceive intelligence as a fixed trait that can not be changed ( entity beliefs ) , whereas others conceive it as a malleable trait that can be developed ( incremental beliefs ) .
-BACKGROUND	What about writing ?
-BACKGROUND	Do people hold similar implicit theories about the nature of their writing ability ?
-BACKGROUND	Furthermore , are these beliefs likely to influence students ' response to a writing intervention ?
-OBJECTIVE	We aimed to develop a scale to measure students ' implicit theories of writing ( pilot study ) and to test whether these beliefs influence strategy-instruction effectiveness ( intervention study ) .
-METHODS	In the pilot and intervention studies participated , respectively , 128 and 192 students ( Grades 5-6 ) .
-METHODS	Based on existing instruments that measure self-theories of intelligence , we developed the Implicit Theories of Writing ( ITW ) scale that was tested with the pilot sample .
-METHODS	In the intervention study , 109 students received planning instruction based on the self-regulated strategy development model , whereas 83 students received standard writing instruction .
-METHODS	Students were evaluated before , in the middle , and after instruction .
-RESULTS	ITW 's validity was supported by piloting results and their successful cross-validation in the intervention study .
-RESULTS	In this , intervention students wrote longer and better texts than control students .
-RESULTS	Moreover , latent growth curve modelling showed that the more the intervention students conceived writing as a malleable skill , the more the quality of their texts improved .
-CONCLUSIONS	This research is of educational relevance because it provides a measure to evaluate students ' implicit theories of writing and shows their impact on response to intervention .
-
-###25302017
-BACKGROUND	Acetaminophen ( APAP ) by oral or intravenous ( iv ) routes is used for mild to moderate pain but may take time to be effective .
-BACKGROUND	When fast relief is required and/or oral or iv routes are not available because of the patient 's condition , the transmucosal route may be an alternative .
-METHODS	A new transmucosal/buccal ( b ) pharmaceutical form of APAP dissolved in 50 % wt alcohol is compared with other routes of administration .
-METHODS	Two consecutive randomized , crossover , double-blind clinical trials ( CT1 : NCT00982215 and CT2 : NCT01206985 ) included 16 healthy volunteers .
-METHODS	CT1 compared the pharmacology of 250 mg bAPAP with 1 g iv APAP .
-METHODS	CT2 compared the pharmacodynamics of 125 mg bAPAP with 1 g iv and 125 mg sublingual ( s ) APAP .
-METHODS	Mechanical pain thresholds are recorded in response to mechanical stimuli applied on the forearm several times during 120 minutes .
-METHODS	The objective is to compare the time of onset of antinociception and the antinociception ( area under the curve ) between the routes of administration with analysis of variance ( significance P < 0.05 ) .
-RESULTS	bAPAP has a faster time of antinociception onset ( 15 minutes , P < 0.01 ) and greater antinociception at 50 minutes ( P < 0.01 , CT1 ) and 30 minutes ( P < 0.01 , CT2 ) than ivAPAP and sAPAP .
-RESULTS	All routes are similar after 50 minutes .
-CONCLUSIONS	bAPAP has a faster antinociceptive action in healthy volunteers .
-CONCLUSIONS	This attractive alternative to other routes would be useful in situations where oral or iv routes are not available .
-CONCLUSIONS	This finding must now be confirmed in patients suffering from acute pain of mild and moderate intensity .
-
-###26016070
-OBJECTIVE	To compare toric intraocular lens implantation ( Toric-IOL ) with peripheral corneal relaxing incisions ( PCRIs ) for astigmatism correction in patients undergoing cataract surgery .
-METHODS	54 patients ( 54 eyes ) with more than 0.75 diopter ( D ) of preexisting corneal astigmatism were classified as group A ( 0.75-1 .50 D ) or group B ( 1.75-2 .50 D ) .
-METHODS	The patients were randomized to undergo Toric-IOL or PCRIs in the steep axis with spherical IOL implantation .
-METHODS	LogMAR uncorrected visual acuity ( LogMAR UCVA ) , LogMAR best corrected visual acuity ( LogMAR BCVA ) , error of vector ( | EV | ) , surgery induced refraction correction ( | SIRC | ) , and correction rates ( CR ) were measured 1 month and 6 months postoperatively .
-RESULTS	At 6 months postoperatively , all 54 eyes had LogMAR BCVA 0.2 .
-RESULTS	Patients who underwent PCRIs and Toric-IOL with LogMAR BCVA 0.1 showed no significant differences in group A ( P = 1.00 ) or in group B ( P = 0.59 ) .
-RESULTS	Group A showed no significant differences in LogMAR UCVA ( P = 0.70 ) , | EV | ( P = 0.13 ) , | SIRC | ( P = 0.71 ) , and CR ( P = 0.56 ) in patients underwent PCRIs and Toric-IOL .
-RESULTS	However , group B showed significant differences in LogMAR UCVA ( P < 0.01 ) , | EV | ( P < 0.01 ) ) , | SIRC | ( P < 0.01 ) , and CR ( P < 0.01 ) .
-RESULTS	The LogMAR UCVA and | EV | between 1 and 6 months showed no significant differences in patients in group A. However , in group B , they are significant differences .
-CONCLUSIONS	The efficacy and stability of Toric-IOL and PCRIs were equal in low astigmatic patients .
-CONCLUSIONS	Toric-IOL achieved an enhanced effect over PCRIs in higher astigmatic patients .
-CONCLUSIONS	PCRIs had the more refractive regression than Toric-IOL in 6 months .
-
-###25882986
-BACKGROUND	Inhibition of angiogenesis is a valuable treatment strategy for ovarian cancer .
-BACKGROUND	Pazopanib is an anti-angiogenic drug active in ovarian cancer .
-BACKGROUND	We assessed the effect of adding pazopanib to paclitaxel for patients with platinum-resistant or platinum-refractory advanced ovarian cancer .
-METHODS	We did this open-label , randomised phase 2 trial at 11 hospitals in Italy .
-METHODS	We included patients with platinum-resistant or platinum-refractory ovarian cancer previously treated with a maximum of two lines of chemotherapy , Eastern Cooperative Oncology Group performance status 0-1 , and no residual peripheral neurotoxicity .
-METHODS	Patients were randomly assigned ( 1:1 ) to receive weekly paclitaxel 80 mg/m ( 2 ) with or without pazopanib 800 mg daily , and stratified by centre , number of previous lines of chemotherapy , and platinum-free interval status .
-METHODS	The primary endpoint was progression-free survival , assessed in the modified intention-to-treat population .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT01644825 .
-METHODS	This report is the final analysis ; the trial is completed .
-RESULTS	Between Dec 15 , 2010 , and Feb 8 , 2013 , we enrolled 74 patients : 37 were randomly assigned to receive paclitaxel and pazopanib and 37 were randomly assigned to receive paclitaxel only .
-RESULTS	One patient , in the paclitaxel only group , withdrew from the study and was excluded from analyses .
-RESULTS	Median follow-up was 161 months ( IQR 125-208 ) .
-RESULTS	Progression-free survival was significantly longer in the pazopanib plus paclitaxel group than in the paclitaxel only group ( median 635 months [ 95 % CI 536-1102 ] vs 349 months [ 201-566 ] ; hazard ratio 042 [ 95 % CI 025-069 ] ; p = 00002 ) .
-RESULTS	We recorded no unexpected toxic effects or deaths from toxic effects .
-RESULTS	Adverse events were more common in the pazopanib and paclitaxel group than in the paclitaxel only group .
-RESULTS	The most common grade 3-4 adverse events were neutropenia ( 11 [ 30 % ] in the pazopanib group vs one [ 3 % ] in the paclitaxel group ) , fatigue ( four [ 11 % ] vs two [ 6 % ] ) , leucopenia ( four [ 11 % ] vs one [ 3 % ] ) , hypertension ( three [ 8 % ] vs none [ 0 % ] ) , raised aspartate aminotransferase or alanine aminotransferase ( three [ 8 % ] vs none ) , and anaemia ( two [ 5 % ] vs five [ 14 % ] ) .
-RESULTS	One patient in the pazopanib group had ileal perforation .
-CONCLUSIONS	Our findings suggest that a phase 3 study of the combination of weekly paclitaxel plus pazopanib for patients with platinum-resistant or platinum-refractory advanced ovarian cancer is warranted .
-BACKGROUND	National Cancer Institute of Napoli and GlaxoSmithKline .
-
-###25010374
-BACKGROUND	Clinical mood disorders often become clinically manifest in the later teenage years and early twenties and can be associated with a poor long-term prognosis .
-BACKGROUND	The primary prevention of these disorders would therefore have great public health value .
-BACKGROUND	Nutritional supplements are a feasible intervention for primary prevention and several epidemiological studies have indicated links between low folate status and depressive symptomatology in the general population .
-METHODS	A randomised , double blind , parallel group , placebo-controlled trial in which participants , aged 14-24 years , at increased familial risk of mood disorder , were randomised to folic acid ( 2.5 mg daily ) or identical placebo liquid for a maximum of 36 months .
-METHODS	Primary outcome data ( the onset of a DSM-IV mood disorder ) were collected from 112 participants ; 56 per group .
-RESULTS	The incidence of mood disorder in the folic acid and placebo groups were 14.3 % and 17.9 % respectively , a non-significant difference .
-RESULTS	However , there was post-hoc evidence that folic acid delayed the time to onset of mood disorder in those participants who became unwell .
-CONCLUSIONS	Small sample size and rate of onset of mood disorders lower than expected .
-CONCLUSIONS	Although long term folic acid supplementation was well tolerated , with high levels of adherence , there was no evidence that it reduced the incidence of mood disorder compared to those taking placebo .
-
-###25442689
-BACKGROUND	A third of the 25 billion people worldwide without access to improved sanitation live in India , as do two-thirds of the 11 billion practising open defecation and a quarter of the 15 million who die annually from diarrhoeal diseases .
-BACKGROUND	We aimed to assess the effectiveness of a rural sanitation intervention , within the context of the Government of India 's Total Sanitation Campaign , to prevent diarrhoea , soil-transmitted helminth infection , and child malnutrition .
-METHODS	We did a cluster-randomised controlled trial between May 20 , 2010 , and Dec 22 , 2013 , in 100 rural villages in Odisha , India .
-METHODS	Households within villages were eligible if they had a child younger than 4 years or a pregnant woman .
-METHODS	Villages were randomly assigned ( 1:1 ) , with a computer-generated sequence , to undergo latrine promotion and construction or to receive no intervention ( control ) .
-METHODS	Randomisation was stratified by administrative block to ensure an equal number of intervention and control villages in each block .
-METHODS	Masking of participants was not possible because of the nature of the intervention .
-METHODS	However , households were not told explicitly that the purpose of enrolment was to study the effect of a trial intervention , and the surveillance team was different from the intervention team .
-METHODS	The primary endpoint was 7-day prevalence of reported diarrhoea in children younger than 5 years .
-METHODS	We did intention-to-treat and per-protocol analyses .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT01214785 .
-RESULTS	We randomly assigned 50 villages to the intervention group and 50 villages to the control group .
-RESULTS	There were 4586 households ( 24,969 individuals ) in intervention villages and 4894 households ( 25,982 individuals ) in control villages .
-RESULTS	The intervention increased mean village-level latrine coverage from 9 % of households to 63 % , compared with an increase from 8 % to 12 % in control villages .
-RESULTS	Health surveillance data were obtained from 1437 households with children younger than 5 years in the intervention group ( 1919 children younger than 5 years ) , and from 1465 households ( 1916 children younger than 5 years ) in the control group .
-RESULTS	7-day prevalence of reported diarrhoea in children younger than 5 years was 88 % in the intervention group and 91 % in the control group ( period prevalence ratio 097 , 95 % CI 083-112 ) .
-RESULTS	162 participants died in the intervention group ( 11 children younger than 5 years ) and 151 died in the control group ( 13 children younger than 5 years ) .
-CONCLUSIONS	Increased latrine coverage is generally believed to be effective for reducing exposure to faecal pathogens and preventing disease ; however , our results show that this outcome can not be assumed .
-CONCLUSIONS	As efforts to improve sanitation are being undertaken worldwide , approaches should not only meet international coverage targets , but should also be implemented in a way that achieves uptake , reduces exposure , and delivers genuine health gains .
-BACKGROUND	Bill & Melinda Gates Foundation , International Initiative for Impact Evaluation ( 3ie ) , and Department for International Development-backed SHARE Research Consortium at the London School of Hygiene & Tropical Medicine .
-
-###25687344
-OBJECTIVE	To test the effectiveness of an integrated collaborative care model for people with depression and long term physical conditions .
-METHODS	Cluster randomised controlled trial .
-METHODS	36 general practices in the north west of England .
-METHODS	387 patients with a record of diabetes or heart disease , or both , who had depressive symptoms ( 10 on patient health questionaire-9 ( PHQ-9 ) ) for at least two weeks .
-METHODS	Mean age was 58.5 ( SD 11.7 ) .
-METHODS	Participants reported a mean of 6.2 ( SD 3.0 ) long term conditions other than diabetes or heart disease ; 240 ( 62 % ) were men ; 360 ( 90 % ) completed the trial .
-METHODS	Collaborative care included patient preference for behavioural activation , cognitive restructuring , graded exposure , and/or lifestyle advice , management of drug treatment , and prevention of relapse .
-METHODS	Up to eight sessions of psychological treatment were delivered by specially trained psychological wellbeing practitioners employed by Improving Access to Psychological Therapy services in the English National Health Service ; integration of care was enhanced by two treatment sessions delivered jointly with the practice nurse .
-METHODS	Usual care was standard clinical practice provided by general practitioners and practice nurses .
-METHODS	The primary outcome was reduction in symptoms of depression on the self reported symptom checklist-13 depression scale ( SCL-D13 ) at four months after baseline assessment .
-METHODS	Secondary outcomes included anxiety symptoms ( generalised anxiety disorder 7 ) , self management ( health education impact questionnaire ) , disability ( Sheehan disability scale ) , and global quality of life ( WHOQOL-BREF ) .
-RESULTS	19 general practices were randomised to collaborative care and 20 to usual care ; three practices withdrew from the trial before patients were recruited .
-RESULTS	191 patients were recruited from practices allocated to collaborative care , and 196 from practices allocated to usual care .
-RESULTS	After adjustment for baseline depression score , mean depressive scores were 0.23 SCL-D13 points lower ( 95 % confidence interval -0.41 to -0.05 ) in the collaborative care arm , equal to an adjusted standardised effect size of 0.30 .
-RESULTS	Patients in the intervention arm also reported being better self managers , rated their care as more patient centred , and were more satisfied with their care .
-RESULTS	There were no significant differences between groups in quality of life , disease specific quality of life , self efficacy , disability , and social support .
-CONCLUSIONS	Collaborative care that incorporates brief low intensity psychological therapy delivered in partnership with practice nurses in primary care can reduce depression and improve self management of chronic disease in people with mental and physical multimorbidity .
-CONCLUSIONS	The size of the treatment effects were modest and were less than the prespecified effect but were achieved in a trial run in routine settings with a deprived population with high levels of mental and physical multimorbidity .
-BACKGROUND	ISRCTN80309252 .
-
-###24621953
-BACKGROUND	Intermittent preventive treatment ( IPT ) in schoolchildren offers a promising option for malaria control .
-BACKGROUND	However , the optimal drug and dosing regimens for IPT remain to be determined .
-METHODS	We conducted a randomized , double-blind , placebo-controlled trial in 740 schoolchildren aged 6-14 years living in a setting of high malaria transmission in Uganda .
-METHODS	Enrolled children were randomized to dihydroartemisinin-piperaquine ( DP ) given once a month ( IPTm ) , DP given once a school term ( 4 treatments over 12 months , IPTst ) , or placebo and followed for 12 months .
-METHODS	The primary outcome was the incidence of malaria over 12 months .
-METHODS	Secondary outcomes included parasite prevalence and anemia over 12 months .
-METHODS	Analyses were conducted on an intention-to-treat basis .
-RESULTS	In the placebo arm , the incidence of malaria was 0.34 episodes per person-year and the prevalence of parasitemia and anemia was 38 % and 20 % , respectively .
-RESULTS	IPTm reduced the incidence of malaria by 96 % ( 95 % confidence interval [ CI ] , 88 % -99 % , P < .0001 ) , the prevalence of asymptomatic parasitemia by 94 % ( 95 % CI , 92 % -96 % , P < .0001 ) , and the prevalence of anemia by 40 % ( 95 % CI , 19 % -56 % , P < .0001 ) .
-RESULTS	IPTst had no significant effect on the incidence of symptomatic malaria or the prevalence of anemia , but reduced the prevalence of asymptomatic parasitemia by 54 % ( 95 % CI , 47 % -60 % , P < .0001 ) .
-CONCLUSIONS	Monthly IPT with DP offered remarkable protection against clinical malaria , parasitemia , and anemia in schoolchildren living in a high-malaria-transmission setting .
-BACKGROUND	NCT01231880 .
-
-###24280575
-BACKGROUND	Pancreatic cancer is often accompanied by severe abdominal or back pain .
-BACKGROUND	It 's the first study to evaluate the analgesic effect of electroacupuncture on pancreatic cancer pain .
-BACKGROUND	A randomized controlled trial compared electroacupuncture with control acupuncture using the placebo needle .
-METHODS	Sixty patients with pancreatic cancer pain were randomly assigned to the electroacupuncture group ( n = 30 ) and the placebo control group ( n = 30 ) .
-METHODS	Patients were treated on Jiaji ( Ex-B2 ) points T8-T12 bilaterally for 30min once a day for 3 days .
-METHODS	Pain intensity was assessed with numerical rated scales ( NRS ) before the treatment ( Baseline ) , after 3 treatments , and 2 days follow-up .
-RESULTS	Baseline characteristics were similar in the two groups .
-RESULTS	After 3 treatment , pain intensity on NRS decreased compared with Baseline ( -1.67 , 95 % confidence interval [ CI ] -1.46 to-1 .87 ) in the electroacupuncture group ; there was little change ( -0.13 , 95 % CI 0.08 to-0 .35 ) in control group ; the difference between two groups was statistically significant ( P < 0.001 ) .
-RESULTS	Follow-up also found a significant reduction in pain intensity in the electroacupuncture group compared with the control group ( P < 0.001 ) .
-CONCLUSIONS	Electroacupuncture was an effective treatment for relieving pancreatic cancer pain .
-
-###25348144
-OBJECTIVE	To establish the prevalence of anthelmintic resistance in ovine gastrointestinal nematodes in southern Queensland .
-METHODS	An observational parasitological study using the faecal egg count reduction test .
-METHODS	Sheep farms ( n = 20 ) enrolled in this study met the twin criteria of using worm testing for drench decisions and having concerns about anthelmintic efficacy .
-METHODS	On each farm , 105 sheep were randomly allocated to one of six treatment groups or an untreated control group .
-METHODS	Faecal samples were collected on day 0 and days 10-14 for worm egg counts and larval differentiation .
-METHODS	Single - and multi-combination anthelmintics , persistent and non-persistent , oral liquid or capsule , pour-on and injectable formulations were tested .
-METHODS	Monepantel was not tested .
-METHODS	Farmers also responded to a questionnaire on drenching practices .
-RESULTS	Haemonchus contortus was the predominant species .
-RESULTS	Efficacy < 95 % was recorded on 85 % of farms for one or more anthelmintics and on 10 % of farms for six anthelmintics .
-RESULTS	No resistance was identified on three farms .
-RESULTS	The 4-way combination product was efficacious ( n = 4 farms ) .
-RESULTS	Napthalophos resistance was detected on one farm only .
-RESULTS	Resistance to levamisole ( 42 % of farms ) , moxidectin injection ( 50 % of farms ) and the closantel/abamectin combination ( 67 % of farms ) was identified .
-RESULTS	Moxidectin oral was efficacious against Trichostrongylus colubriformis , which was predominant on only one farm .
-RESULTS	Of the farms tested , 55 % ran meat breeds , 60 % dosed more than the recommended dose rate and 70 % always , mostly or when possible practised a ` drench and move ' strategy .
-CONCLUSIONS	This level of anthelmintic resistance in southern Queensland will severely compromise worm control and force increased use of monepantel .
-
-###24257391
-BACKGROUND	Caudal block ( CB ) has some disadvantages , one of which is its short duration of action after a single injection .
-BACKGROUND	For hypospadias repair , pudendal nerve block ( PNB ) might be a suitable alternative since it has been successfully used for analgesia for circumcision .
-BACKGROUND	We evaluated PNB compared with CB as measured by total analgesic consumption 24 hours postoperatively .
-METHODS	In this prospective , double-blinded study , patients were randomized into 2 groups , either receiving CB or nerve stimulator-guided PNB .
-METHODS	In the PNB group , patients were injected with 0.3 mL/kg 0.25 % bupivacaine and 1 g/kg clonidine .
-METHODS	In the CB group , patients were injected with 1 mL/kg 0.25 % bupivacaine and 1 g/kg clonidine .
-METHODS	Analgesic consumption was assessed during the first 24 hours postoperatively .
-METHODS	The `` objective pain scale '' developed by Hannalah and Broadman was used to assess postoperative pain .
-RESULTS	Eighty patients participated in the study , 40 in each group .
-RESULTS	The mean age in the PNB group was 3.1 ( 1.1 ) years and in the CB group was 3.2 ( 1.1 ) years .
-RESULTS	The mean weights in the PNB and CB groups were 15.3 ( 2.8 ) kg and 15.3 ( 2.2 ) kg , respectively .
-RESULTS	The percentage of patients who received analgesics during the first 24 hours were significantly higher in the CB ( 70 % ) compared with the PNB group ( 20 % , P < 0.0001 ) .
-RESULTS	The average amount of analgesics consumed per patient within 24 hours postoperatively was higher in the CB group ( paracetamol P < 0.0001 , Tramal P = 0.003 ) .
-CONCLUSIONS	Patients who received PNB had reduced analgesic consumption and pain within the first 24 hours postoperatively compared with CB .
-
-###25333793
-OBJECTIVE	Human papillomavirus ( HPV ) self-sampling ( Self-HPV ) may be used as a primary cervical cancer screening method in a low resource setting .
-OBJECTIVE	Our aim was to evaluate whether an educational intervention would improve women 's knowledge and confidence in the Self-HPV method .
-METHODS	Women aged between 25 and 65 years old , eligible for cervical cancer screening , were randomly chosen to receive standard information ( control group ) or standard information followed by educational intervention ( interventional group ) .
-METHODS	Standard information included explanations about what the test detects ( HPV ) , the link between HPV and cervical cancer and how to perform HPV self-sampling .
-METHODS	The educational intervention consisted of a culturally tailored video about HPV , cervical cancer , Self-HPV and its relevancy as a screening test .
-METHODS	All participants completed a questionnaire that assessed sociodemographic data , women 's knowledge about cervical cancer and acceptability of Self-HPV .
-RESULTS	A total of 302 women were enrolled in 4 health care centers in Yaound and the surrounding countryside .
-RESULTS	301 women ( 149 in the `` control group '' and 152 in the `` intervention group '' ) completed the full process and were included into the analysis .
-RESULTS	Participants who received the educational intervention had a significantly higher knowledge about HPV and cervical cancer than the control group ( p < 0.05 ) , but no significant difference on Self-HPV acceptability and confidence in the method was noticed between the two groups .
-CONCLUSIONS	Educational intervention promotes an increase in knowledge about HPV and cervical cancer .
-CONCLUSIONS	Further investigation should be conducted to determine if this intervention can be sustained beyond the short term and influences screening behavior .
-BACKGROUND	International Standard Randomised Controlled Trial Number ( ISRCTN ) Register ISRCTN78123709 .
-
-###24930619
-OBJECTIVE	The benefits of combined systemic and liver-directed treatments in inoperable intermediate - or advanced-stage hepatocellular carcinoma ( HCC ) have yet to be defined .
-OBJECTIVE	This article presents the planned safety analyses for the first 40 patients randomized to radioembolization with yttrium-90 ( ( 90 ) Y ) resin microspheres followed by sorafenib ( n = 20 ) or sorafenib only ( n = 20 ) in the SORAMIC study .
-METHODS	Patients identified for palliative treatment who were poor candidates for transarterial ( chemo ) embolization ( including those failing TACE ) with preserved liver function ( Child-Pugh B7 ) and ECOG performance status < 2 were screened .
-METHODS	Radioembolization was administered using a sequential lobar approach .
-METHODS	On day 3 after the last radioembolization procedure , sorafenib 200 mg twice daily was initiated escalating to 400 mg twice daily 1 week later ; a matching sorafenib dose schedule was initiated in the control arm .
-RESULTS	Patients were followed up for a median of 8.3 months .
-RESULTS	Median total implanted activity of ( 90 ) Y was 1.87 ( range : 0.54-2 .35 ) GBq .
-RESULTS	Patients received a similar intensity and duration of sorafenib in the combination-treatment arm ( median daily dose 614 mg over 8.5 months ) and control arm ( 557 mg over 9.6 months ) .
-RESULTS	The incidence of total ( 196 vs. 222 ) and grade 3 ( 43 vs. 47 ) adverse events was similar in combination-treatment arm and control arm respectively ( P > 0.05 ) .
-RESULTS	No significant differences in the number of total or grade 3/4 toxicities were recorded for : total bilirubin , albumin , liver enzymes , ascites , Child-Pugh , fatigue , hand-foot skin reaction , blood pressure or diarrhoea .
-CONCLUSIONS	Radioembolization followed by sorafenib appears to be as well tolerated as sorafenib alone .
-
-###24519844
-BACKGROUND	Subcutaneous drainage is considered effective for preventing wound infections , but only anecdotal evidence supports its clinical benefit .
-BACKGROUND	The present study evaluated the benefit of subcutaneous drainage in preventing wound infections in patients undergoing liver resection .
-METHODS	Patients scheduled for liver resection were randomly assigned to receive or not receive subcutaneous drains .
-METHODS	After suture of the peritoneum and fascia , a 10 Fr drain was placed subcutaneously and connected to a low pressure ( under 80cmH2 O ) aspiration reservoir to allow drainage of the full length of the wound .
-METHODS	The primary endpoint was wound infection development within 30 days of the liver resection .
-RESULTS	We performed liver resections in 260 patients with hepatobiliary malignancies .
-RESULTS	Between the subcutaneous-drainage group ( n = 131 ) and non-drainage group ( n = 129 ) , there were no significant differences in the operative variables .
-RESULTS	Wound infection occurred in 10 drainage group patients ( 8 % ) and 12 patients ( 9 % ) in the non-drainage group ( P = 0.629 ) ; there was no significant difference in the probability of wound infection ( P = 0.624 ) .
-RESULTS	No significant differences were found between the groups for the hospital stay duration ( P = 0.363 ) , postoperative complications ( P = 0.725 ) or medical expenses ( P = 0.360 ) .
-CONCLUSIONS	Subcutaneous drainage does not prevent wound infections in patients undergoing liver resection ; therefore , its routine use is not justified .
-
-###24370761
-OBJECTIVE	While portable , supplemental oxygen is often necessary for patients with chronic obstructive pulmonary disease ( COPD ) to retain independence , it may provide functional limitations because of the increased workload imposed .
-OBJECTIVE	This issue may result in nonuse , creating a need to identify carrying modalities that optimize transport .
-OBJECTIVE	This study assessed the effects of 3 methods of portable oxygen transport on 6-minute walk distance ( 6 MWD ) , rate of perceived exertion ( RPE ) , heart rate ( HR ) , and oxyhemoglobin saturation ( SpO2 ) .
-OBJECTIVE	As weight status is known to impact functional ability in COPD , effects of body mass index ( BMI ) were also assessed .
-METHODS	Data were analyzed using the mixed-model procedure to test for effects of transport modality ( reference , rolling cart , backpack , shoulderstrap ) , time ( minutes 1-6 ) , BMI , non-overweight , overweight , and interactions of these variables on outcome parameters .
-RESULTS	A main effect of condition was found for 6 MWD , and an interaction of condition BMI was found for HR and RPE , and of time BMI for 6 MWD and SpO2 .
-RESULTS	Participants walked the least distance in rolling cart condition , which was also characterized by the greatest RPE .
-RESULTS	For the overweight group , HR was least in the reference compared with other conditions ; but for the non-overweight group , the opposite pattern was observed .
-RESULTS	At latter time points , 6 MWD was greater in the non-overweight group , while SpO2 was reduced .
-CONCLUSIONS	Results demonstrate that transport modality of portable oxygen exerts differential effects on functional performance in COPD patients and that BMI may moderate underlying physiologic factors that contribute to performance outcomes .
-
-###25446490
-BACKGROUND	An increasing body of evidence is being published about single-incision laparoscopic cholecystectomy ( SILC ) , but there are no well-powered trials with an adequate evaluation of post-operative pain .
-BACKGROUND	This randomized trial compares SILC against four-port laparoscopic cholecystectomy ( LC ) with post-operative pain as the primary endpoint .
-METHODS	Hundred patients were randomized to either SILC ( n = 50 ) or LC ( n = 50 ) .
-METHODS	Exclusion criteria were ( 1 ) Acute cholecystitis ; ( 2 ) ASA 3 or above ; ( 3 ) Bleeding disorders ; and ( 4 ) Previous open upper abdominal surgery .
-METHODS	Patients and post-operative assessors were blinded to the procedure performed .
-METHODS	The site and severity of pain were compared at 4 h , 24 h , 14 days and 6 months post-procedure using the visual analog scale ; non-inferiority was assumed when the lower boundary of the 95 % confidence interval of the difference was above -1 and superiority when p 0.05 .
-RESULTS	The study arms were demographically similar .
-RESULTS	At 24 h post-procedure , SILC was associated with less pain at extra-umbilical sites ( rest : p = 0.004 ; movement : p = 0.008 ) .
-RESULTS	Pain data were inconclusive at 24 h at the umbilical site on movement ; SILC was otherwise non-inferior for pain at all other points .
-RESULTS	Operating duration was longer in SILC ( 79.46 vs 58.88 min , p = 0.003 ) .
-RESULTS	8 % of patients in each arm suffered complications ( p = 1.000 ) .
-RESULTS	Re-intervention rates , analgesic use , return to function , and patient satisfaction did not differ significantly .
-CONCLUSIONS	SILC has improved short-term pain outcomes compared to LC and is not inferior in both short-term and long-term pain outcomes .
-CONCLUSIONS	The operating time is longer , but remains feasible in routine surgical practice .
-
-###24283778
-BACKGROUND	In COPD , the long-acting bronchodilators are not always able to provide an appropriate bronchodilator effect in terms of amplitude and duration and this can result in increased severity of respiratory symptoms and in worsening of health status .
-BACKGROUND	Combined long-acting bronchodilators can address this limitation .
-METHODS	Analysis of a recent study evaluating the efficacy and safety of 26 weeks of therapy with glycopyrronium + indacaterol single inhaler ( QVA149 ) versus each component , versus tiotropium and versus placebo .
-CONCLUSIONS	Such a combination can provide a superior and sustained bronchodilator effect and can minimize the respiratory symptoms resulting from a suboptimally inhibited bronchoconstriction .
-
-###25721356
-BACKGROUND	Docetaxel plus prednisone is a standard treatment for castration-resistant prostate cancer .
-BACKGROUND	Cyclophosphamide may be an effective combination partner .
-METHODS	This randomised , multicentre , phase II trial compared the combination therapy of docetaxel plus prednisone plus cyclophosphamide with the standard therapy of docetaxel plus prednisone .
-RESULTS	Thirty-three patients received six 3-week treatment cycles ( in total 171 cycles ) .
-RESULTS	During treatment , an adequate decline in prostate-specific antigen was seen in both groups ( p = 0.068 ) without between-group differences ( p = 0.683 ) .
-RESULTS	No relevant differences between within-group changes were observed for blood pressure , weight , pain score , laboratory variables or quality of life .
-RESULTS	There were no serious side effects apart from leucopenia requiring treatment ( docetaxel + prednisone + cyclophosphamide arm ) and no drug-related withdrawals ; all three fatalities were considered to be cancer related .
-CONCLUSIONS	The oncological effectiveness and tolerability of docetaxel plus prednisone were supported ; an additional effect of cyclophosphamide was not detected .
-CONCLUSIONS	However , the small number of patients and short observation period restrict the generalisability of the results .
-
-###25299534
-OBJECTIVE	This study aimed to compare continuous and pulsed ultrasound therapy with sham ultrasound in terms of pain , severity of muscle spasm , function , depression , and quality of life in patients with myofascial pain syndrome .
-METHODS	Patients were randomly divided into three groups , including the continuous ultrasound group ( 3 MHz , 1 W/cm , n = 20 ) , the pulsed ultrasound group ( 3 MHz , 1 W/cm , 1:1 ratio , n = 20 ) , and control group ( sham , n = 20 ) .
-METHODS	The primary outcome measures were severity of pain at rest and during activity ( visual analog scale , 0-10 cm ) .
-METHODS	The secondary outcome measures were function ( Neck Pain and Disability Scale ) , depressive mood ( Beck Depression Scale ) , and quality of life ( Nottingham Health Profile ) .
-METHODS	All evaluations were performed at baseline , after treatment , and at the 6th and 12th wks .
-RESULTS	All three groups had significant improvements in all of the pain scores , the severity of muscle spasms , function assessments , and certain subparameters of the quality of life scale ( P < 0.05 ) .
-RESULTS	The continuous ultrasound group had significantly greater improvements in pain at rest ( P < 0.05 ) .
-RESULTS	However , no statistically significant differences were observed in the other parameters ( P > 0.05 ) .
-CONCLUSIONS	Continuous ultrasound therapy is more efficient in reducing pain at rest for myofascial pain syndrome patients than is sham or pulsed ultrasound therapy .
-
-###25247908
-BACKGROUND	There is little systematic research on the efficacy and tolerability of the addition of adjunctive analgesic agents in paravertebral analgesia .
-BACKGROUND	The addition of adjunctive analgesics , such as fentanyl and clonidine , to local anesthetics has been shown to enhance the quality and duration of sensory neural blockades , and decrease the dose of local anesthetic and supplemental analgesia .
-OBJECTIVE	Investigation of the safety and the analgesic efficacy of adding 1 g/kg dexmedetomidine to bupivacaine 0.25 % in thoracic paravertebral blocks ( PVB ) in patients undergoing modified radical mastectomy .
-METHODS	A randomized , double-blind trial .
-METHODS	Academic medical center .
-METHODS	Sixty American Society of Anesthesiologists physical status - I - III patients were randomly assigned to receive thoracicPVB with either 20 mL of bupivacaine 0.25 % ( Group B , n = 30 ) , or 20 mL of bupivacaine 0.25 % + 1 g/kg dexmedetomidine ( Group BD , n = 30 ) .
-METHODS	Assessment parameters included hemodynamics , sedation score , pain severity , time of first analgesics request , total analgesic consumption , and side effects in the first 48 hours .
-RESULTS	There was a significant reduction in pulse rate and diastolic blood pressure starting at 30 minutes in both groups , but more evidenced in group BD ( P < 0.001 ) .
-RESULTS	Intraoperative Systolic blood pressure showed a significant reduction at 30 minutes in both groups ( P < 0.001 ) then returned to baseline level at 120 minutes in both groups .
-RESULTS	There was a significant increase in pulse rate starting 2 hours postoperative until 48 hours postoperatively in group B but only after 12 hours until 48 hours in group BD ( P < 0.001 ) .
-RESULTS	The time of the first rescue analgesic requirement was significantly prolonged in the group BD ( 8.16 42 hours ) in comparison to group B ( 6.48 5.24 hours ) ( P = 0.04 ) .
-RESULTS	The mean total consumption of intravenous tramadol rescue analgesia in the postanesthesia care unit in the firtst 48 hours postoperatively was significantly decreased in group BD ( 150.19 76.98 mg ) compared to group B ( 194.44 63.91 mg ) ( P = 0.03 ) .
-RESULTS	No significant serious adverse effects were recorded during the study .
-CONCLUSIONS	This study is limited by its sample size .
-CONCLUSIONS	The addition of dexmedetomidine 1 g/kg to bupivacaine 0.25 % in thoracic PVB in patients undergoing modified radical mastectomy improves the quality and the duration of analgesia and also provides an analgesic sparing effect with no serious side effects .
-
-###24604528
-BACKGROUND	Regular exercise has been proposed as a potential smoking cessation aid .
-OBJECTIVE	This study aimed to determine the effects of an exercise counseling program on cigarette smoking abstinence at 24weeks .
-METHODS	A parallel , two-arm , randomized controlled trial was conducted .
-METHODS	Adult cigarette smokers ( n = 906 ) who were insufficiently active and interested in quitting were randomized to receive the Fit2Quit intervention ( 10 exercise telephone counseling sessions over 6months ) plus usual care ( behavioral counseling and nicotine replacement therapy ) or usual care alone .
-RESULTS	There were no significant group differences in 7-day point-prevalence and continuous abstinence at 6months .
-RESULTS	The more intervention calls successfully delivered , the lower the probability of smoking ( OR , 0.88 ; 95 % CI 0.81-0 .97 , p = 0.01 ) in the intervention group .
-RESULTS	A significant difference was observed for leisure time physical activity ( difference = 219.11 MET-minutes/week ; 95 % CI 52.65-385 .58 ; p = 0.01 ) .
-CONCLUSIONS	Telephone-delivered exercise counseling may not be sufficient to improve smoking abstinence rates over and above existing smoking cessation services .
-CONCLUSIONS	( Australasian Clinical Trials Registry Number : ACTRN12609000637246 . )
-
-###24565129
-OBJECTIVE	The aim of this randomized , double-blinded , prospective study was to determine the effectiveness and side effects of intravenous or epidural use of morphine , bupivacaine or ropivacaine on post-thoracotomy pain management .
-METHODS	Sixty patients undergoing elective thoracotomy procedure were randomly allocated into 4 groups by the sealed envelope technique .
-METHODS	Group IVM , EM , EMB and EMR received patient controlled intravenous morphine , and epidural morphine , morphine-bupivacaine and morphine-ropivacaine , respectively .
-METHODS	Perioperative heart rate , blood pressure and oxygen saturation and postoperative pain at rest and during cough , side effects and rescue analgesic requirements were recorded at the 30 ( th ) and 60 ( th ) minutes and the 2 ( nd ) , 4 ( th ) , 6 ( th ) , 12 ( th ) , 24 ( th ) , 36 ( th ) , 48 ( th ) , and 72 ( nd ) hour .
-RESULTS	Diclofenac sodium requirement during the study was lower in Group EM .
-RESULTS	Area under VAS-time curve was lower in Group EM compared to Group IVM , but similar to Group EMB and EMR .
-RESULTS	Pain scores at rest were higher at the 12 , 24 , 36 , and 48 ( th ) hour in Group IVM compared to Group EM .
-RESULTS	Pain scores at rest were higher at the 30 ( th ) and 60 ( th ) minutes in Group EM and Group IVM compared to Group EMB .
-RESULTS	Pain scores during cough at the 30 ( th ) minute were higher in Group EM compared to Group EMB .
-RESULTS	There was no difference between Group IVM and Group EMR .
-CONCLUSIONS	Morphine used at the epidural route was found more effective than the intravenous route .
-CONCLUSIONS	While Group EM was more effective in the late period of postoperative , Group EMB was more effective in the early period .
-CONCLUSIONS	We concluded that epidural morphine was the most effective and preferred one .
-
-###24451122
-BACKGROUND	Daclatasvir-containing regimens have the potential to address limitations of current regimens combining peginterferon alfa and ribavirin with first-generation protease inhibitors for treatment of chronic HCV genotype 1 infection .
-METHODS	In this randomized , double-blind study , 27 Japanese treatment-naive patients received once-daily daclatasvir 10 mg or 60 mg or placebo , each combined with peginterferon alfa-2b / ribavirin ; 18 prior null ( n = 9 ) or partial ( n = 9 ) responders received the same daclatasvir-containing regimens without a placebo arm .
-METHODS	Daclatasvir recipients with protocol-defined response ( HCV RNA < 15 IU/ml at week 4 , undetectable at week 12 ) were treated for 24 weeks ; those without protocol-defined response and placebo recipients continued treatment to week 48 .
-RESULTS	Sustained virological response 24 weeks post-treatment ( SVR24 ) was achieved by 66.7 % , 90.0 % and 62.5 % of treatment-naive patients in the daclatasvir 10 mg , 60 mg and placebo groups , respectively .
-RESULTS	Prior non-responders had more frequent virological failure ; 22.2 % and 33.3 % of daclatasvir 10 mg and 60 mg recipients , respectively , achieved SVR24 .
-RESULTS	Adverse events were similar across groups and were typical of peginterferon alfa-2b / ribavirin .
-RESULTS	Pyrexia , headache , alopecia , decreased appetite and malaise were the most common adverse events ; two daclatasvir recipients discontinued due to adverse events .
-CONCLUSIONS	Daclatasvir 60 mg combined with peginterferon alfa-2b and ribavirin achieved a high rate of SVR24 in treatment-naive patients with HCV genotype 1 infection , with tolerability similar to that of peginterferon alfa-2b / ribavirin alone .
-CONCLUSIONS	However , regimens with greater antiviral potency are needed for prior non-responders .
-
-###24267513
-BACKGROUND	Traumatic brain injury ( TBI ) is commonly accompanied by intracranial bleeding which can worsen after hospital admission .
-BACKGROUND	Tranexamic acid ( TXA ) has been shown to reduce bleeding in elective surgery and there is evidence that short courses of TXA can reduce rebleeding in spontaneous intracranial haemorrhage .
-BACKGROUND	We aimed to determine the effectiveness and safety of TXA in preventing progressive intracranial haemorrhage in TBI .
-METHODS	This is a double blinded , placebo controlled randomized trial .
-METHODS	We enrolled 238 patients older than 16years with moderate to severe TBI ( post-resuscitation Glasgow Coma Scale ( GCS ) 4 to 12 ) who had a computerized tomography ( CT ) brain scan within eight hours of injury and in whom there was no immediate indication for surgery .
-METHODS	We excluded patients if they had a coagulopathy or a serum creatinine over than 2.0 milligrams % .
-METHODS	The treatment was a single dose of 2 grams of TXA in addition to other standard treatments .
-METHODS	The primary outcome was progressive intracranial haemorrhage ( PIH ) which was defined as an intracranial haemorrhage seen on the second CT scan that was not seen on the first CT scan , or an intracranial haemorrhage seen on the first scan that had expanded by 25 % or more on any dimension ( height , length , or width ) on the second scan .
-RESULTS	Progressive intracranial haemorrhage was present in 21 ( 18 % ) of 120 patients allocated to TXA and in 32 ( 27 % ) of 118 patients allocated to placebo .
-RESULTS	The difference was not statistically significant [ RR = 0.65 ( 95 % CI 0.40 to 1.05 ) ] .
-RESULTS	There were no significant difference in the risk of death from all causes in patients allocated to TXA compared with placebo [ RR = 0.69 ( 95 % CI 0.35 to 1.39 ) ] and the risk of unfavourable outcome on the Glasgow Outcome Scale [ RR = 0.76 ( 95 % CI 0.46 to 1.27 ) ] .
-RESULTS	There was no evidence of increased risk of thromboembolic events in those patients allocated to TXA .
-CONCLUSIONS	TXA may reduce PIH in patients with TBI ; however , the difference was not statistically significant in this trial .
-CONCLUSIONS	Large clinical trials are needed to confirm and to assess the effect of TXA on death or disability after TBI .
-
-###25251294
-OBJECTIVE	The aims of this study were to adapt a traditional recipe into a healthier form by adding 3 g of oat - glucan , substituting milk chocolate to dark chocolate with 70 % cocoa , and to examine the effect of these alterations on short-term satiety and energy intake .
-METHODS	Study subjects ( n = 25 ) were tested in a randomized , crossover design with four products closely matched for energy content .
-METHODS	Four different versions of a traditional recipe including milk chocolate-control ( CON ) , oat - glucan ( B-GLU ) , dark chocolate ( DARK ) or oat - glucan and dark chocolate ( B-GLU + DARK ) were given to subjects on different test days .
-METHODS	After subjects were asked to report visual analog scale ( VAS ) scores on sensory outcomes and related satiety for four hours ad libitum , lunch was served and energy intake of individuals was measured .
-RESULTS	VAS scores indicated that none of the test foods exerted an improved effect on satiety feelings .
-RESULTS	However , energy intake of individuals during ad libitum lunch was significantly lower in dark chocolate groups ( CON : 849.46 47.45 kcal versus DARK : 677.69 48.45 kcal and B-GLU + DARK : 691.08 47.45 kcal , p = 0.014 ) .
-CONCLUSIONS	The study demonstrated that substituting dark chocolate for milk chocolate is more effective in inducing satiety during subsequent food intake in healthy subjects .
-
-###25183042
-BACKGROUND	In recent years , the U.S. has experienced a significant increase in the prevalence of pregnant opioid-dependent women and of neonatal abstinence syndrome ( NAS ) , which is caused by withdrawal from in-utero drug exposure .
-BACKGROUND	While methadone-maintenance currently is the standard of care for opioid dependence during pregnancy , research suggests that buprenorphine-maintenance may be associated with shorter infant hospital lengths of stay ( LOS ) relative to methadone-maintenance .
-BACKGROUND	There is no `` gold standard '' treatment for NAS but there is evidence that buprenorphine , relative to morphine or methadone , treatment may reduce LOS and length of treatment .
-METHODS	Point-of-care clinical trial ( POCCT ) designs , maximizing external validity while reducing cost and complexity associated with classic randomized clinical trials , were selected for two planned trials to compare methadone to buprenorphine treatment for opioid dependence during pregnancy and for NAS .
-METHODS	This paper describes design considerations for the Medication-assisted treatment for Opioid-dependent expecting Mothers ( MOMs ; estimated N = 370 ) and Investigation of Narcotics for Ameliorating Neonatal abstinence syndrome on Time in hospital ( INFANTs ; estimated N = 284 ) POCCTs , both of which are randomized , intent-to-treat , two-group trials .
-METHODS	Outcomes would be obtained from participants ' electronic health record at three participating hospitals .
-METHODS	Additionally , a subset of infants in the INFANTs POCCT would be from mothers in the MOMs POCCT and , thus , potential interaction between medication treatment of mother and infant could be evaluated .
-CONCLUSIONS	This pair of planned POCCTs would evaluate the comparative effectiveness of treatments for opioid dependence during pregnancy and for NAS .
-CONCLUSIONS	The results could have a significant impact on practice .
-
-###25133822
-OBJECTIVE	Uptake of human papillomavirus ( HPV ) vaccinations by 17 - to 18-year-old girls in England is below ( < 35 % ) target ( 80 % ) .
-OBJECTIVE	This trial assesses ( a ) the impact of financial incentives on uptake and completion of an HPV vaccination program , and ( b ) whether impacts are moderated by participants ' deprivation level .
-OBJECTIVE	It also assesses the impact of incentives on decision quality to get vaccinated , as measured by attitudes toward the vaccination and knowledge of its consequences .
-METHODS	One thousand 16 - to 18-year-old girls were invited to participate in an HPV vaccination program : 500 previously uninvited , and 500 unresponsive to previous invitations .
-METHODS	Girls randomly received either a standard invitation letter or a letter including the offer of vouchers worth 45 ( 56 ; $ 73 ) for undergoing 3 vaccinations .
-METHODS	Girls attending their first vaccination appointment completed a questionnaire assessing decision quality to be vaccinated .
-METHODS	Outcomes were uptake of the first and third vaccinations and decision quality .
-RESULTS	The intervention increased uptake of the first ( first-time invitees : 28.4 % vs. 19.6 % , odds ratio [ OR ] = 1.63 , 95 % confidence interval [ CI ; 1.08 , 2.47 ] ; previous nonattenders : 23.6 % vs. 10.4 % , OR = 2.65 , 95 % CI [ 1.61 , 4.38 ] ) and third ( first-time invitees : 22.4 % vs. 12 % , OR = 2.15 , 95 % CI [ 1.32 , 3.50 ] ; previous nonattenders : 12.4 % vs. 3 % , OR = 4.28 , 95 % CI [ 1.92 , 9.55 ] ) vaccinations .
-RESULTS	Impacts were not moderated by deprivation level .
-RESULTS	Decision quality was unaffected by the intervention .
-CONCLUSIONS	Although the intervention increased completion of HPV vaccinations , uptake remained lower than the national target , which , in addition to cost effectiveness and acceptability issues , necessitates consideration of other ways of achieving it .
-
-###24780407
-OBJECTIVE	To test whether subconjunctival cyclosporine A ( CsA ) implants affect the incidence and the degree of corneal neovascularization occurring after penetrating keratoplasty .
-METHODS	Prospective , randomized , multicenter , controlled phase 2/3 clinical trial .
-METHODS	The study comprised 43 trial sites in Germany , India , and the United States .
-METHODS	Enrolled patients ( n = 97 ) were randomized to 1 of 3 groups : treatment group A ( n = 36 ) , treatment group B ( n = 40 ) , and the control group ( n = 21 ) .
-METHODS	Patients from each group received either of 2 doses of subconjunctival CsA ( group A , low-dose CsA ; group B , high-dose CsA ) or placebo ( carrier only ) implants at the time of high-risk penetrating keratoplasty .
-METHODS	The incidence and degree of corneal neovascularization occurring after penetrating keratoplasty were evaluated in a substudy ( LX201-01 study : NCT00447187 ) .
-METHODS	A web-based image upload system was developed .
-METHODS	Standardized digital slit-lamp pictures were quantitatively and objectively evaluated using CellF morphometry software .
-RESULTS	No statistically significant difference in incidence and degree of corneal neovascularization developing after penetrating keratoplasty was found between treatment groups and placebo group .
-RESULTS	Mean corneal neovascularization area at week 52 ( visit 12 ) was 2.321.79 % in treatment group A versus placebo ( 2.792.11 % ; P = 0.45 ) and 2.742.22 % in treatment group B versus placebo ( 2.792.11 % ; P = 0.94 ) .
-CONCLUSIONS	High-dose subconjunctival CsA implants do not significantly affect corneal neovascularization after high-risk penetrating keratoplasty .
-CONCLUSIONS	This suggests that local CsA has negligible antiangiogenic effects in the human cornea , at least in the transplant setting .
-
-###25496727
-BACKGROUND	Cardiovascular diseases ( CVD ) and metabolic alterations are among the majors public health concern that have been reported in people living with HIV infections .
-BACKGROUND	Factors contributing to cardio metabolic syndrome in HIV include body fat distribution , dyslipidemia , insulin resistance , cardiovascular dysfunction and inflammation .
-BACKGROUND	The aim of the study was to determine the effect of Spirulina platensis ( Cyanobacteriaceae ) supplementation versus local diet on lipid profile in HIV-infected antiretroviral-naive patients .
-METHODS	A prospective single-blind , randomized , multicentre study was conducted from February 2010 to December 2012 .
-METHODS	A total of 320 HIV antiretroviral-nave patients were screened and 169 were recruited in this study .
-METHODS	Patients were randomized and received either Spirulina supplementation combined with local diet ( n = 82 ) or local diet only ( n = 87 ) .
-METHODS	Age , weight , body mass index ( BMI ) , lipid profile , CD4 count , and local food intake variables were assessed on three separate occasions ( three , six and twelve months ) .
-RESULTS	An average age of the patients was 35.69 years .
-RESULTS	The majority of participants were female 67.1 % .
-RESULTS	Regarding the lipid profile , there is a significant increase in HDL-cholesterol and a significant decrease in total cholesterol , LDL-cholesterol and triglycerides in the group of patients who consumed Spirulina platensis .
-RESULTS	A change in the atherogenic index defined by the ratio CT/HDL-C substitutable by LDL-C/HDL-C and the TC/HDL decreased significantly from 10.83 at baseline to 2.22 after 12 months ( p = 0.21 and p < 0.0001 ) in the patients taking Spirulina .
-CONCLUSIONS	Nutritional supplementation with Spirulina combined with a quantitative and qualitative balanced diet for at least six months can retard an exposition to lipid abnormalities in HIV-infected antiretroviral-naive patients .
-CONCLUSIONS	Further studies are recommended on a large group of people not infected with HIV and exposed to cardiovascular risk factors .
-
-###25161043
-BACKGROUND	In the Strategic Reperfusion Early After Myocardial Infarction ( STREAM ) trial , a pharmaco-invasive ( PI ) strategy was compared with primary percutaneous coronary intervention ( pPCI ) in ST-segment-elevation myocardial infarction patients presenting within 3 hours after symptom onset but unable to undergo pPCI within 1 hour .
-BACKGROUND	At 30 days , the PI approach was associated with a nominally but nonstatistically significant lower incidence of the composite primary end point of death , shock , congestive heart failure , and reinfarction when compared with pPCI .
-BACKGROUND	The aim of the present study was to determine the effect of these strategies on 1-year mortality .
-RESULTS	Vital status at 1 year was available in 936 of 944 ( 99.2 % ) and 941 of 948 ( 99.3 % ) patients in the PI and pPCI arm , respectively .
-RESULTS	At 1 year , all-cause mortality rates ( 6.7 % versus 5.9 % ) were similar for PI and pPCI-treated patients ( P = 0.49 ; risk ratio , 1.13 ; 95 % confidence interval , 0.79-1 .62 ) .
-RESULTS	Cardiac mortality rates were similar as well ( 4.0 % versus 4.1 % , P = 0.93 ; risk ratio , 0.98 ; 95 % confidence interval , 0.62-1 .54 ) .
-RESULTS	Overall , only 34 patients died between day 30 and 1 year , 20 in the PI arm and 14 in the pPCI arm , of whom 20 died of noncardiac reasons ( 13 in the PI and 7 in the pPCI arm ) .
-RESULTS	There was no significant difference in 1-year all-cause mortality between the 2 groups among the prespecified key subgroups .
-CONCLUSIONS	At 1 year , mortality rates in the PI and pPCI arms were similar in ST-segment-elevation myocardial infarction patients presenting within 3 hours after symptom onset and unable to undergo pPCI within 1 hour .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00623623 .
-
-###24306321
-OBJECTIVE	To use measurement by cycling power meters ( Pmes ) to evaluate the accuracy of commonly used models for estimating uphill cycling power ( Pest ) .
-OBJECTIVE	Experiments were designed to explore the influence of wind speed and steepness of climb on accuracy of Pest .
-OBJECTIVE	The authors hypothesized that the random error in Pest would be largely influenced by the windy conditions , the bias would be diminished in steeper climbs , and windy conditions would induce larger bias in Pest .
-METHODS	Sixteen well-trained cyclists performed 15 uphill-cycling trials ( range : length 1.3-6 .3 km , slope 4.4-10 .7 % ) in a random order .
-METHODS	Trials included different riding position in a group ( lead or follow ) and different wind speeds .
-METHODS	Pmes was quantified using a power meter , and Pest was calculated with a methodology used by journalists reporting on the Tour de France .
-RESULTS	Overall , the difference between Pmes and Pest was -0.95 % ( 95 % CI : -10.4 % , +8.5 % ) for all trials and 0.24 % ( -6.1 % , +6.6 % ) in conditions without wind ( < 2 m/s ) .
-RESULTS	The relationship between percent slope and the error between Pest and Pmes were considered trivial .
-CONCLUSIONS	Aerodynamic drag ( affected by wind velocity and orientation , frontal area , drafting , and speed ) is the most confounding factor .
-CONCLUSIONS	The mean estimated values are close to the power-output values measured by power meters , but the random error is between 6 % and 10 % .
-CONCLUSIONS	Moreover , at the power outputs ( > 400 W ) produced by professional riders , this error is likely to be higher .
-CONCLUSIONS	This observation calls into question the validity of releasing individual values without reporting the range of random errors .
-
-###25071414
-BACKGROUND	Communication and information in order to reduce anxiety in the intensive care unit ( ICU ) has been described as area needing improvement .
-BACKGROUND	Therefore , the aim of this trial was to evaluate whether a structured information program that intensifies information given in standard care process reduces anxiety in ICU patients .
-METHODS	Multicenter , two-armed , non-blinded , parallel-group randomized controlled trial in hospitals in the cities of Marburg , Halle , and Stuttgart ( Germany ) .
-METHODS	The trial was performed in cardiac surgery , general surgery , and internal medicine ICUs .
-METHODS	Two-hundred and eleven elective and non-elective ICU patients were enrolled in the study ( intervention group , n = 104 ; control group , n = 107 ) .
-METHODS	The experimental intervention comprised a single episode of structured oral information that was given in addition to standard care and covered two main parts : ( 1 ) A more standardized part about predefined ICU specific aspects - mainly procedural , sensory and coping information , and ( 2 ) an individualized part about fears and questions of the patient .
-METHODS	The control group received a non-specific episodic conversation of similar length additional to standard care .
-METHODS	Both conversations took place at the beginning of the ICU stay and lasted 10-15 minutes .
-METHODS	Study nurses administered both interventions .
-METHODS	The primary outcome ICU-related anxiety ( CINT-Score , 0-100 pts. , higher scores indicate higher anxiety ) was assessed after admission to a regular ward .
-RESULTS	The primary outcome could be measured in 82 intervention group participants and 90 control group participants resulting in mean values of 20.4 ( SD 14.4 ) compared to 20.8 ( SD 14.7 ) and a mean difference of -0.2 ( CI 95 % -4.5 to 4.1 ) .
-CONCLUSIONS	A structured information intervention additional to standard care during ICU stay had no demonstrated additional benefit compared to an unspecific communication of similar duration .
-CONCLUSIONS	Reduction of anxiety in ICU patients will probably require more continuous approaches to information giving and communication .
-BACKGROUND	ClinicalTrials.gov NCT00764933 .
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-###25465108
-BACKGROUND	High blood pressure is associated with poor outcome after stroke .
-BACKGROUND	Whether blood pressure should be lowered early after stroke , and whether to continue or temporarily withdraw existing antihypertensive drugs , is not known .
-BACKGROUND	We assessed outcomes after stroke in patients given drugs to lower their blood pressure .
-METHODS	In our multicentre , partial-factorial trial , we randomly assigned patients admitted to hospital with an acute ischaemic or haemorrhagic stroke and raised systolic blood pressure ( systolic 140-220 mm Hg ) to 7 days of transdermal glyceryl trinitrate ( 5 mg per day ) , started within 48 h of stroke onset , or to no glyceryl trinitrate ( control group ) .
-METHODS	A subset of patients who were taking antihypertensive drugs before their stroke were also randomly assigned to continue or stop taking these drugs .
-METHODS	The primary outcome was function , assessed with the modified Rankin Scale at 90 days by observers masked to treatment assignment .
-METHODS	This study is registered , number ISRCTN99414122 .
-RESULTS	Between July 20 , 2001 , and Oct 14 , 2013 , we enrolled 4011 patients .
-RESULTS	Mean blood pressure was 167 ( SD 19 ) mm Hg/90 ( 13 ) mm Hg at baseline ( median 26 h [ 16-37 ] after stroke onset ) , and was significantly reduced on day 1 in 2000 patients allocated to glyceryl trinitrate compared with 2011 controls ( difference -70 [ 95 % CI -85 to -56 ] mm Hg / -35 [ -44 to -26 ] mm Hg ; both p < 00001 ) , and on day 7 in 1053 patients allocated to continue antihypertensive drugs compared with 1044 patients randomised to stop them ( difference -95 [ 95 % CI -118 to -72 ] mm Hg / -50 [ -64 to -37 ] mm Hg ; both p < 00001 ) .
-RESULTS	Functional outcome at day 90 did not differ in either treatment comparison-the adjusted common odds ratio ( OR ) for worse outcome with glyceryl trinitrate versus no glyceryl trinitrate was 101 ( 95 % CI 091-113 ; p = 083 ) , and with continue versus stop antihypertensive drugs OR was 105 ( 090-122 ; p = 055 ) .
-CONCLUSIONS	In patients with acute stroke and high blood pressure , transdermal glyceryl trinitrate lowered blood pressure and had acceptable safety but did not improve functional outcome .
-CONCLUSIONS	We show no evidence to support continuing prestroke antihypertensive drugs in patients in the first few days after acute stroke .
-BACKGROUND	UK Medical Research Council .
-
-###24984529
-OBJECTIVE	The mercury sphygmomanometer has been the gold standard used for obtaining blood pressure ( BP ) for the National Health and Nutrition Examination Survey ( NHANES ) from 1960 to the present .
-OBJECTIVE	However , due to environmental concerns and an increased use of automated oscillometric BP devices , NHANES has been exploring an alternative to using the standard mercury sphygmomanometer ( mercury ) to measure BP .
-METHODS	The accuracy of Omron HEM-907XL BP readings was compared with that of mercury BP device readings for gender , age group , race and ethnicity , and body mass index categories and cuff-size subgroups .
-METHODS	Each person had three BP measurements per device recorded sequentially .
-METHODS	The order of the devices and readers were randomly assigned .
-METHODS	A total of 6,460 participants had three valid systolic readings , and 6,338 had three valid diastolic readings .
-RESULTS	Omron and mercury measurements were correlated ( r = 0.92 , systolic BP ; r = 0.79 , diastolic BP ) .
-RESULTS	Overall , the mean between-device differences ( Omron and mercury ) were -1.6 mm Hg for systolic and -0.6 mm Hg for diastolic ( p < 0.05 for both ) .
-RESULTS	The mean between-device differences were less than or about 2 mm Hg for each subgroup : gender , age group , race and ethnicity , and body mass index categories , and cuff-size subgroups .
-RESULTS	The exceptions were mean systolic between-device differences for those using the extra-large BP cuff ( -3.1 mm Hg ) and obese individuals ( -2.6 mm Hg ) , and the mean diastolic between-device differences for the underweight group ( -3.5 mm Hg ) .
-RESULTS	Assuming mercury to be the gold standard , between-device agreements for the frequency of high BP ( 140/90 mm Hg or more ) and stage II high BP ( 160/100 mm Hg or more ) were above chance ( kappa = 0.72 for both ) .
-RESULTS	Omron underestimated the high BP frequency by 2.28 % and stage II high BP frequency by 0.77 % .
-CONCLUSIONS	Lower estimates of high BP by the Omron device may require adjusting future national prevalence estimates accordingly to account for between-device differences .
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-###25496425
-BACKGROUND	Challenging behaviors exhibited by individuals with dementia might result from an unmet need that they can not communicate directly due to cognitive restrictions .
-BACKGROUND	A dementia-specific case conference represents a promising means of analyzing and exploring these unmet needs .
-BACKGROUND	The ongoing FallDem study is a stepped-wedged , cluster-randomized trial evaluating the effects of two different types of dementia-specific case conferences on the challenging behaviors of nursing home residents .
-BACKGROUND	This study protocol describes the process evaluation that is conducted , along with the FallDem study.The goal of the process evaluation is to explain potential discrepancies between expected and observed outcomes , and to provide insights into implementation processes and recruitment strategies , as well as the contexts and contextual factors that promote or inhibit the implementation of dementia-specific case conferences .
-METHODS	The process evaluation will use a mixed-method design comprising longitudinal elements , in which quantitative and qualitative data will be gathered .
-METHODS	Qualitative data will be analyzed using content analysis , documentary analysis and a documentary method .
-METHODS	Quantitative data ( standardized questionnaires ) will be analyzed using descriptive statistics .
-METHODS	Both types of data will complement one another and provide a more comprehensive picture of the different objects under investigation .
-CONCLUSIONS	The process evaluation will allow for a comprehensive understanding of the changing processes and mechanisms underlying the ` black box ' of the complex intervention of the FallDem study .
-CONCLUSIONS	These findings will provide practical knowledge regarding issues related to the implementation of dementia-specific case conferences in nursing homes .
-BACKGROUND	Current Controlled Trials identifier : ISRCTN20203855 , registered on 10th July 2013 .
-
-###24735840
-OBJECTIVE	The Achilles tendon is a tissue that responds to mechanical loads at a molecular and cellular level .
-OBJECTIVE	In vitro and in vivo studies have shown that the expression of anabolic and/or catabolic proteins can change within hours of loading and return to baseline levels within 72h .
-OBJECTIVE	These biochemical changes have not been correlated with changes in whole tendon structure on imaging .
-OBJECTIVE	We examined the nature and temporal sequence of changes in Achilles tendon structure in response to competitive game loads in elite Australian football players .
-METHODS	Elite male Australian football players with no history of Achilles tendinopathy were recruited .
-METHODS	Achilles tendon structure was quantified using ultrasound tissue characterisation ( UTC ) imaging , a valid and reliable measure of intratendinous structure , the day prior to the match ( day 0 ) , and then reimaged on days 1 , 2 and 4 postgame .
-RESULTS	Of the 18 participants eligible for this study , 12 had no history of tendinopathy ( NORM ) and 6 had a history of patellar or hamstring tendinopathy ( TEN ) .
-RESULTS	Differences in baseline UTC echopattern were observed between the NORM and TEN groups , with the Achilles of the TEN group exhibiting altered UTC echopattern , consistent with a slightly disorganised tendon structure .
-RESULTS	In the NORM group , a significant reduction in echo-type I ( normal tendon structure ) was seen on day 2 ( p = 0.012 ) that returned to baseline on day 4 .
-CONCLUSIONS	There was a transient change in UTC echopattern in the Achilles tendon as a result of an Australian football game in individuals without a history of lower limb tendinopathy .
-
-###25491659
-OBJECTIVE	To assess the feasibility of conducting a randomized trial comparing two strategies [ physician ( MD ) vs. non-physician ( non-MD ) ] for approaching substitute decision makers ( SDMs ) for research and to evaluate SDMs ' experiences in being approached for consent .
-METHODS	A pilot mixed methods study of first encounters with SDMs .
-RESULTS	Of 137 SDMs ( 162 eligibility events ) , 67 and 70 were randomized to MD and non-MD introductions , respectively .
-RESULTS	Eighty SDMs ( 98 events ) provided consent and 21 SDMs ( 24 events ) declined consent for studies , including 2 SDMs who provided and declined consent .
-RESULTS	We identified few missed introductions [ 4/52 ( 7.7 % ) ] and protocol violations [ 6/117 ( 5.1 % ) ] , high comfort , satisfaction and acceptance scores and similar consent rates in both arms .
-RESULTS	SDMs provided consent significantly more often when a patient update was provided in the MD arm .
-RESULTS	Most SDMs ( 85.7 % ) felt that physician involvement was inconsequential and preferred physician time to be dedicated to patient care ; however , SDM experiences were closely related to their recall of being approached and recall was poor .
-RESULTS	SDMs highlighted 7 themes of importance to them in research surrogate decision-making .
-CONCLUSIONS	SDMs prioritized the personal attributes of the person approaching them over professional designation and preferred physician time to be dedicated to patient care .
-CONCLUSIONS	A mixed methods design evaluated intervention fidelity and provided the rationale for not proceeding to a larger trial , despite achieving all feasibility metrics in the pilot trial .
-BACKGROUND	NCT01232621 .
-
-###24643489
-OBJECTIVE	Describe the three-year results of a program designed for the adoption of a healthy life style in primary school students on the body mass index ( BMI ) and the consumption of food .
-METHODS	Community randomized and controlled trial .
-METHODS	Two communities in the State of Mexico with similar socio-demographic characteristics were randomized to implement the intervention ( n = 816 ) or serve as a control ( n = 408 ) .
-METHODS	The intervention was carried out in primary schools and it consisted of education on healthy habits , modification of distributed food and physical activity .
-METHODS	The primary outcome was the change in BMI .
-RESULTS	After three years , intervention resulted in a lower increase of BMI ( 1.6 vs. 1.9 Kg/m , p < 0.01 ) and a decreased consumption of total calories , bread , fat and sugar consumption in the schools .
-CONCLUSIONS	School programs are useful to address childhood obesity , but its benefits are not immediate .
-
-###24298760
-OBJECTIVE	To evaluate the clinical efficacy of electroacupuncture ( EA ) for apoplectic urinary incontinence .
-METHODS	Two hundred and four cases of apoplectic urinary incontinence were randomized into an EA group ( 136 cases ) and an indwelling catheter group ( 68 cases ) .
-METHODS	The EA was applied at Qugu ( CV 2 ) , Zhongji ( CV 3 ) , Shuidao ( ST 28 ) , Qihai ( CV 6 ) and Guanyuan ( CV 4 ) , etc. in the EA group ,5 times a week .
-METHODS	Indwelling catheter was applied in the indwelling catheter group at intervals of 2-4 hours , and periodic bladder irrigation along with bladder rehabilitation training were also given .
-METHODS	The efficacies were evaluated after 4 weeks of treatment .
-METHODS	Before and after treatment , the urination diary ( including the interval of urination , nocturia frequency , urination difficulty , urinary incontinence severity ) , bladder capacity , patients ' satisfaction of the two groups were observed and the efficacy was evaluated .
-RESULTS	The total effective rate was 96.2 % ( 125/130 ) in the EA group , which was apparently superior to 87.5 % ( 56/64 ) in the indwelling catheter group ( P < 0.05 ) ; except for nocturia frequency in the indwelling catheter group , the total score and the subitem score in the urination diary were all improved significantly after treatment in both groups ( all P < 0.001 ) , which were more obvious in the EA group ( P < 0.001 , P < 0.05 ) ; the patients ' satisfaction and bladder capacity were all improved significantly after treatment in both groups ( all P < 0.001 ) , which were more obvious in the EA group ( both P < 0.001 ) .
-CONCLUSIONS	The EA has an obvious effect for apoplectic urinary incontinence in urinary incontinence alleviation and bladder capacity increase , which has better efficacy than indwelling catheter therapy .
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-###24866508
-OBJECTIVE	To determine changes in Canine Brief Pain Inventory scores for dogs with osteoarthritis after administration of a monoclonal antibody ( mAb ) against nerve growth factor ( NGF ) that was modified by use of a proprietary process for administration to dogs .
-METHODS	11 adult dogs .
-METHODS	Dogs received the anti-NGF mAb ( 0.2 mg/kg , IV ) at various evaluation times during the study period ; at other evaluation times , dogs received an equivalent volume of PBS solution IV .
-METHODS	Owners determined Canine Brief Pain Inventory pain severity ( PS ) and pain interference ( PI ) scores immediately before ( baseline ) and 2 , 4 , and 6 weeks after administration of the anti-NGF mAb ; owners were unaware of the evaluation time at which the mAb had been administered .
-RESULTS	Compared with baseline PS scores ( median , 4.75 ; range , 0.75 to 8.5 ) , dogs had significantly lower PS scores 2 weeks ( median , 3 ; range , 1 to 5.5 ) and 4 weeks ( median , 2.25 ; range , 0.25 to 7.25 ) after administration of anti-NGF mAb .
-RESULTS	Compared with baseline PI scores ( median , 5.33 ; range , 1.17 to 9.33 ) , dogs had significantly lower PI scores 2 weeks ( median , 3 ; range , 0.67 to 6.83 ) and 4 weeks ( median , 3.33 ; range , 0.67 to 6.67 ) after administration of anti-NGF mAb .
-RESULTS	The PS and PI scores 6 weeks after mAb administration were lower than baseline scores , although values were not significantly different .
-CONCLUSIONS	Results of this study suggested the evaluated anti-NGF mAb decreased PS and PI scores for 4 weeks after administration .
-CONCLUSIONS	This treatment may be effective for alleviation of signs of pain in dogs with osteoarthritis for up to 4 weeks .
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-###24254339
-BACKGROUND	Dilation-assisted stone extraction , also termed small endoscopic sphincterotomy ( EST ) plus endoscopic papillary balloon dilatation , is more efficient than EST alone for removal of large common bile duct ( CBD ) stones .
-BACKGROUND	However , whether this technique can be used for all stones is unclear .
-OBJECTIVE	This study was designed to evaluate the efficacy and complications of dilation-assisted stone extraction for CBD stones .
-METHODS	A total of 462 patients with CBD stones were randomized to undergo either dilation-assisted stone extraction ( group A ) or EST ( group B ) .
-METHODS	The efficacy and complications of the two techniques were compared .
-RESULTS	Groups A and B showed similar outcomes in terms of stone removal .
-RESULTS	The short-term and 1-year complication rates were also similar between the two groups .
-RESULTS	However , the first-session stone removal rate in group A was significantly higher than that in group B. Mechanical lithotripsy was required significantly more often in group B than in group A.
-RESULTS	The total procedure time and total fluoroscopy time in group A were significantly shorter than those in group B.
-CONCLUSIONS	Dilation-assisted stone extraction and EST are safe and effective techniques for the treatment of CBD stones .
-CONCLUSIONS	Dilation-assisted stone extraction has high efficiency .
-CONCLUSIONS	This technique is an alternative method for removal of CBD stones .
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-###24627569
-BACKGROUND	The 5-amino acid ( AA ) signature , including isoleucine , leucine , valine , tyrosine , and phenylalanine , has been associated with incident diabetes mellitus and insulin resistance .
-BACKGROUND	We investigated whether this same AA signature , single-nucleotide polymorphisms in genes in their catabolic pathway , was associated with development of impaired fasting glucose ( IFG ) after atenolol treatment .
-RESULTS	Among 234 European American participants enrolled in the Pharmacogenomic Evaluation of Antihypertensive Responses ( PEAR ) study and treated with atenolol for 9 weeks , we prospectively followed a nested cohort that had both metabolomics profiling and genotype data available for the development of IFG .
-RESULTS	We assessed the association between baseline circulating levels of isoleucine , leucine , valine , tyrosine , and phenylalanine , as well as single-nucleotide polymorphisms in branched-chain amino-acid transaminase 1 ( BCAT1 ) and phenylalanine hydroxylase ( PAH ) with development of IFG .
-RESULTS	All baseline AA levels were strongly associated with IFG development .
-RESULTS	Each increment in standard deviation of the 5 AAs was associated with the following odds ratio and 95 % confidence interval for IFG based on a fully adjusted model : isoleucine 2.29 ( 1.31-4 .01 ) , leucine 1.80 ( 1.10-2 .96 ) , valine 1.77 ( 1.07-2 .92 ) , tyrosine 2.13 ( 1.20-3 .78 ) , and phenylalanine 2.04 ( 1.16-3 .59 ) .
-RESULTS	The composite P value was 210 ( -5 ) .
-RESULTS	Those with PAH ( rs2245360 ) AA genotype had the highest incidence of IFG ( P for trend = 0.0003 ) .
-CONCLUSIONS	Our data provide important insight into the metabolic and genetic mechanisms underlying atenolol-associated adverse metabolic effects .
-CONCLUSIONS	Clinical Trial Registration - http://www.clinicaltrials.gov; Unique Identifier : NCT00246519 .
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-###24439349
-BACKGROUND	Tobacco use is still the leading preventable cause of death and morbidity in the U.S. Web-assisted tobacco interventions are an effective but underutilized tool in assisting smokers with quitting .
-BACKGROUND	The dental visit is an excellent opportunity to assist smokers in quitting by referring them to these tobacco-cessation online programs .
-OBJECTIVE	The study purpose was to test two patient referral methods-paper referrals ( information prescriptions ) versus paper plus e-referrals-to a web-assisted smoking-cessation induction system .
-METHODS	RCT that used implementation research methods .
-METHODS	A total of 100 community-based dental practices were enrolled and 1814 smokers were referred to the web-assisted tobacco induction system .
-METHODS	The study intervention was a proactive e-referral of smokers to a web-assisted tobacco induction system called Decide2Quit.org , and the control group used paper referrals ( information prescriptions ) to refer smokers to the Decide2Quit.org .
-METHODS	The outcome measurements were the referral numbers , Decide2Quit registration numbers , and the smokers ' quit rate .
-METHODS	Data were collected in 2010-2011 and analyses were completed in 2012 .
-RESULTS	Although total referrals from intervention practices was lower than control , subsequent proportions of registrations among smokers referred to Decide2Quit.org were nearly fourfold higher ( adjusted mean percentages : 29.5 % vs 7.6 % , p < 0.01 ) in intervention compared with control practices .
-RESULTS	Subsequent rates of cessation among referred smokers were threefold higher ( adjusted mean percentages : 3.0 % vs 0.8 % , p = 0.03 ) in intervention practices as compared with control .
-CONCLUSIONS	Intervention practices using the e-referral system had higher smoker registration numbers and higher quit smoking rates than the control practices .
-CONCLUSIONS	This study finds that e-referrals are effective in getting smokers to the web-assisted smoking-cessation induction system and in assisting with quitting that more than compensates for any additional effort that e-referrals require on the part of the practitioner .
-BACKGROUND	DPBRN Hygienists Internet Quality Improvement in Tobacco Cessation ( HiQuit ) ; NCT01108432 .
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-###24895813
-OBJECTIVE	The plasticity of bone marrow stem cells has been confirmed to self-renew and transdifferentiate into hepatocytes .
-OBJECTIVE	Thus , we performed autologous stem cell transplantation for rapid liver regeneration with extensive hepatectomy in hepatocellular cancer patients .
-METHODS	With informed consent , patients aged 20 to 75 who needed large extensive hepatectomy due to hepatocellular carcinoma were randomly divided into three groups : control , mononuclear cells ( MNCs ) , and CD34 + cells , based on infused cell type .
-METHODS	After portal vein embolization ( PVE ) , mobilized MNCs or CD34 + cells were returned to the patient via the portal vein on mobilization day without manipulation .
-METHODS	Liver volume , liver function , clinical score and Indocyanine green R15 ( ICG-R15 ) were compared before and after PVE .
-RESULTS	Total bilirubin , albumin , and clinical score showed significant improvement ( p < 0.05 ) 1 week post-infusion , with no significant difference between MNC and CD34 + cell groups .
-RESULTS	Four patients ( control , 1 ; MNC , 1 ; CD34 + , 2 ) started at over 18 % ICG-R15 but can be overturned after PVE .
-RESULTS	Daily hepatic volume growth ( mL/day ) was 2.5 for MNC and 4.9 for CD34 + groups , resulting in significant increase over controls ( 1.1 ; p < 0.05 ) .
-RESULTS	We found no correlation between the number of applied CD34 + cells and daily gains in left lateral lobe volume .
-CONCLUSIONS	Improvements in liver volume , liver function , clinical score and ICG-R15 suggest that autologous stem cell transplantation is a promising method for liver regeneration .
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-###25545543
-BACKGROUND	The aim of this study was to investigate the agreement between body composition measurements made with two methods-single-frequency bioelectrical impedance analysis ( SF-BIA ) and bioelectrical impedance spectroscopy ( BIS ) .
-METHODS	The body composition measurements using SF-BIA and BIS were performed seven times during 6 months on 41 patients ( 13 men and 28 women ) with metabolic syndrome who were taking part in a dietary intervention study .
-RESULTS	The mean [ standard deviation ( SD ) ] fat mass ( FM ) and median [ interquartile range ( IQR ) ] FM % measured with SF-BIA were 32.7 ( 6.7 ) kg and 36.3 ( 30.3-39 .3 ) % , respectively , compared with 38.2 ( 8.7 ) kg and 40.9 ( 35.5-45 .6 ) % , respectively , using BIS .
-RESULTS	The median ( IQR ) fat-free mass ( FFM ) was 60.0 ( 53.3-73 .5 ) kg according to SF-BIA and 55.4 ( 48.8-66 .5 ) kg according to BIS .
-RESULTS	These results obtained with the two methods were significantly different ( P < 0.001 ) .
-RESULTS	Still highly significant correlations were found between the results obtained with SF-BIA and BIS for FM and FFM ( all r0 .89 , P < 0.001 ) .
-RESULTS	Using Bland-Altman analysis , the bias was found to be -5.4 ( 4.1 ) kg for FM , -5.5 ( 3.7 ) % for FM % , and 5.4 ( 4.1 ) kg for FFM .
-RESULTS	Rather wide limits of agreement were found for FM , FM % , and FFM .
-CONCLUSIONS	Body composition data obtained using SF-BIA and BIS in subjects with metabolic syndrome were highly correlated but not interchangeable .
-CONCLUSIONS	FM was systematically lower when using SF-BIA than when using BIS .
-
-###25428446
-BACKGROUND	Generics have the potential to contain drug therapy costs ; successful implementation of generic substitution policy largely depends on consumers ' willingness to choose generics .
-OBJECTIVE	This study aims to analyse the opinions , experiences and preferences of Polish patients towards generic medicines .
-METHODS	The study was performed in Poland .
-METHODS	The survey was conducted in June 2013 by means of face-to-face interviews .
-METHODS	Respondents were drawn from the general population according to a population structure .
-METHODS	The study covered a representative sample of 1,000 Poles ; the results can be generalized to apply to the Polish population at large .
-RESULTS	Fifty-two percent of respondents declared to be more often choosing generics , twenty-three percent did not have any specific preferences , and twenty-five percent were more willing to choose brand-name medicines .
-RESULTS	Past experience with cheaper generic medicines , secondary or lower education , low income and residence in specific regions of Poland were all significantly associated with an increased willingness to choose generics .
-RESULTS	Respondents ' attitudes towards generics were mostly influenced by the opinions of doctors and pharmacists .
-RESULTS	According to respondents , attitudes towards generics among doctors , pharmacists , family and friends , and in the mass media were mostly positive .
-RESULTS	There was no relationship between the preference of respondents for generics and factors such as their age , life stage , gender , household size or urban/rural locality .
-RESULTS	As a result of substituting a brand-name drug with its generic equivalent , 72 % of respondents reported that they had not noticed any difference in drug effectiveness ; 21 % had experienced a reduced effectiveness of treatment or increased side effects at least once ; and 7 % claimed the generic worked better .
-RESULTS	The majority of respondents who used cheaper substitutes claimed that generics represented good or very good quality .
-CONCLUSIONS	The study demonstrates that , when choosing medicines , Poles rely mainly on the opinions of their doctors and pharmacists .
-CONCLUSIONS	Therefore , it is recommended that : ( 1 ) the option of using generics be promoted when writing prescriptions , and ( 2 ) the obligation on pharmacists to inform customers of their option to purchase generics be enforced .
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-###24903468
-OBJECTIVE	Insertion of a nasopharyngeal airway ( NPA ) during endoscopic sedation is only recommended in the event of respiratory problems .
-OBJECTIVE	We evaluated the safety and efficacy of routine insertion of an NPA during sedation in gastrointestinal ( GI ) endoscopy .
-METHODS	Between July 2009 and April 2012 , patients with colonoscopy or expected longer-lasting or therapeutic upper GI endoscopy were pseudo-randomized in a weekly alternating fashion to perform sedation ( midazolam in combination with propofol ) with or without NPA insertion .
-METHODS	The primary outcome measure was respiratory depression ( oxygen saturation < 90 % ) .
-METHODS	Secondary measures included hypotension ( systolic blood pressure < 90 mm Hg ) , bradycardia ( heart rate < 40 beats/min ) or nasopharyngeal damage after NPA insertion .
-RESULTS	216 ( 106 females , mean age 60.7 9.65 years ) were enrolled .
-RESULTS	Colonoscopy was performed in 131 patients and upper endoscopy in 85 patients .
-RESULTS	In 105 patients an NPA was used ( intervention group ) .
-RESULTS	Five ( 4.7 % ) of those patients showed minor nasopharyngeal injury .
-RESULTS	Respiratory depression ( 13.5 vs. 1.9 % , p = 0.002 ) and hypotension ( 11 vs. 5 % , p = 0.09 ) occurred more frequently in the control than in the intervention group .
-CONCLUSIONS	The routine placement of an NPA can reduce the frequency of hypoxemic events during endoscopic sedation with minor risks for nasopharyngeal injury .
-
-###24851869
-BACKGROUND	Chronic hypoxia is a risk factor for cardiovascular disease , but its association with blood pressure ( BP ) remains unclear .
-BACKGROUND	We performed this study to clarify the hypothesis that chronic hypoxia is associated with abnormal BP variability in patients with pneumoconiosis .
-METHODS	We recruited 19 patients with pneumoconiosis and 30 age - and BP level-matched control subjects .
-METHODS	We used simultaneous pulse oximetry and ambulatory BP monitoring for all subjects .
-METHODS	We evaluated their BP levels and variability by determining the SD and coefficient of variation ( CV ) of the BP data .
-METHODS	The dipper pattern was defined as nocturnal BP fall 10 % ; the nondipper pattern was defined as nocturnal BP fall 0 % but < 10 % ; the riser pattern was defined as nocturnal BP fall < 0 % .
-METHODS	Pearson and Spearman correlation coefficients were used to calculate the correlations between parameters .
-RESULTS	In patients with pneumoconiosis , the daytime systolic BP ( SBP ) level was lower , the CV in 24-hour SBP ( P < 0.05 ) and diastolic BP ( P < 0.001 ) were higher than that in control subjects .
-RESULTS	And although not statistically significant ( P = 0.13 ) , the odds ratio of riser pattern was 3.73 in patients with pneumoconiosis , and their nighttime pulse rate was significantly higher ( P < 0.05 ) than that in control subjects .
-RESULTS	The median daytime pulse oximetry oxygen saturation was inversely associated with mean ( r = -0.30 ; P < 0.01 ) and SD ( r = -0.38 ; P < 0.001 ) in daytime SBP .
-RESULTS	The median nighttime pulse oximetry oxygen saturation was inversely associated ( r = -0.55 ; P < 0.001 ) and the mean nighttime pulse rate was associated ( r = 0.51 ; P < 0.001 ) with CV in nighttime SBP .
-RESULTS	Partial pressure of oxygen was inversely associated with CV in daytime SBP ( r = -0.24 ; P < 0.05 ) .
-CONCLUSIONS	Exaggerated BP variability was seen in patients with pneumoconiosis , and the measures of hypoxia were associated with large fluctuations in ambulatory BP .
-CONCLUSIONS	Chronic and intermittent hypoxia could be the contributing factors of these findings .
-BACKGROUND	Clinical Trial Number UMIN000000894 ( University Hospital Medical Information Network Clinical Trials Registry website ) .
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-###25615272
-OBJECTIVE	The goal of this study was to investigate the extent to which sample length affected the reliability of total number of words ( TNW ) , number of different words ( NDW ) , and mean length of C-units in morphemes ( MLCUm ) in parent-elicited conversational samples for 3-year-olds .
-METHODS	Participants were sixty 3-year-olds .
-METHODS	A 22-min language sample was collected from each child during free play with the parent in the laboratory .
-METHODS	Samples of 1 , 3 , 7 , and 10 min were extracted from the 22-min samples .
-METHODS	TNW , NDW , and MLCUm were computed from each shorter sample and the 22-min sample .
-METHODS	TNW and NDW were adjusted by number of minutes for comparisons .
-METHODS	The differences and correlations between each shorter sample cut and the 22-min sample on MLCUm and adjusted TNW and NDW were computed .
-RESULTS	The shorter samples and the 22-min samples significantly differed in adjusted TNW and NDW , but not in MLCUm .
-RESULTS	TNW reached an acceptable reliability level ( i.e. , r = .90 ) in 7-min samples .
-RESULTS	NDW and MLCUm approached the acceptable reliability level ( rs = .88 ) in 7-min samples and reached it in 10-min samples .
-CONCLUSIONS	For conversational language samples with similar collection procedures , samples of 7 to 10 min are desirable for calculating TNW , NDW , and MLCUm in 3-year-olds .
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-###25367184
-OBJECTIVE	Off-midline procedures seem to be the best method of primary wound closure after excision of a pilonidal sinus .
-OBJECTIVE	Primary wound closure with a Limberg flap was compared to secondary wound healing .
-METHODS	From January 2006 to July 2012 , 102 patients with given informed consent ( mean age 28 years , men 81 % ) who had excision of a pilonidal sinus in three hospitals in Switzerland were randomised to group L ( Limberg flap , n = 51 ) or to group E ( excision only , n = 51 ) .
-METHODS	Primary endpoint was duration of incapacity for work .
-METHODS	Follow-up was at 3 weeks and at 1 year postoperative ( 95 % follow-up ) .
-RESULTS	Both groups were comparable with regard to patient characteristics .
-RESULTS	The median ( range ) operation time was 60 ( 30-80 ) min in group L vs. 30 ( 10-75 ) min in group E ( p < 0.001 ) .
-RESULTS	No significant differences were found in postoperative pain and painkiller intake ; pain , percentage of patients at work and overall satisfaction at 3 weeks postoperative ; and overall duration of incapacity for work and overall satisfaction at 1-year follow-up .
-RESULTS	The complication rate was 49 % in group L vs. 12 % in group E ( p < 0.001 ) .
-RESULTS	Complications in group L were seroma ( 6 % ) , wound dehiscence ( 45 % ) , skin necrosis ( 10 % ) , hematoma ( 6 % ) , infection ( 4 % ) and recurrent disease ( 13 % ) .
-RESULTS	Complications in group E were recurrent disease ( 6 % ) and wound healing disorder ( 6 % ) .
-CONCLUSIONS	After excision of a pilonidal sinus , primary wound closure with a Limberg flap has no advantage over secondary wound healing .
-CONCLUSIONS	The main reason for this conclusion is the relatively high complication rate of primary wound closure with a Limberg flap .
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-###24660607
-OBJECTIVE	To observe capillary blood flow at acupoints during acupuncture treatment of primary dysmenorrhea and gain new insights into its analgesic mechanism .
-METHODS	Patients with primary dysmenorrhea were enrolled and randomly assigned to a treatment or control group .
-METHODS	Subjects ' symptoms were differentiated into various Traditional Chinese Medicine ( TCM ) syndromes and treated for 10 sessions with puncturing acupuncture or self-pressing right-hand Hegu ( LI 4 ) , adding other acupoints based on syndrome .
-METHODS	Laser speckle was used to compare the change in the vasomotor amplitude and perfusion of the capillaries in Hegu ( LI 4 ) before and during the treatment .
-METHODS	Each subject was required to finish the period pain symptoms observation form , verbal rating scales , numerical rating scale , pain rating index , face rating scale , Zung self-rating depression scale , Zung self-rating anxiety scale , and numerical rating scale before and after treatments .
-RESULTS	After 10 sessions , the symptom scores , pain index ( PI ) , and visual analog scale ( VAS ) decreased significantly in treatment group .
-RESULTS	The volume of blood flow in Hegu ( LI 4 ) declined slightly .
-RESULTS	No significant evidence supported that needling caused capillary contraction , but the capillary vasomotor amplitude at Hegu ( LI 4 ) increased remarkably .
-CONCLUSIONS	Acupuncture can increase the capillary blood flow , thus promoting the flow of Qi and blood in terms ofTCM theory , which facilitates pain relief .
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-###24520910
-BACKGROUND	Caring for a family member with dementia is extremely stressful , and contributes to psychiatric and physical illness among caregivers .
-BACKGROUND	Therefore , a comprehensive programme called Resources for Enhancing Alzheimer 's Caregiver Health II ( REACH II ) was developed in the United States to enhance the health of Alzheimer 's caregivers .
-BACKGROUND	REACH II causes a clear reduction of the stress and burdens faced by informal caregivers at home .
-BACKGROUND	The aim of this protocol is to adapt , apply , and evaluate this proven intervention programme in a German-speaking area for the first time .
-BACKGROUND	This newly adapted intervention is called Deutsche Adaption der Resources for Enhancing Alzheimer 's Caregiver Health ( DeREACH ) .
-METHODS	A total of 138 informal caregivers at home are recruited in a single-centred , randomised controlled trial .
-METHODS	The intervention ( DeREACH ) consists of nine home visits and three telephone contacts over six months , all of which focus on safety , psychological well-being and self-care , social support , problem behaviour and preventive health-related behaviours .
-METHODS	A complex intervention assessment on effectiveness will be adopted when the primary outcome - namely , the reduction of caregiver burden - and other secondary outcomes , including changes with regard to anxiety and depression , somatisation , health-related quality of life , and perceived social support , are measured at baseline , as well as immediately and three months after the intervention .
-METHODS	The change from baseline to post-intervention assessment with regard to the primary outcome will be compared between treatment and control group using t-tests for independent samples .
-CONCLUSIONS	It is anticipated that this study will show that DeREACH effectively reduces caregiver burden and therefore works under the conditions of a local German health-care system .
-CONCLUSIONS	If successful , this programme will provide an effective intervention programme in the German-speaking area to identify and develop the personal capabilities of informal caregivers to cope with the burdens of caring for people with dementia .
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-###24706596
-BACKGROUND	Episodes of patient deterioration on hospital units are expected to increasingly contribute to morbidity and healthcare costs .
-OBJECTIVE	To determine if real-time alerts sent to the rapid response team ( RRT ) improved patient care .
-METHODS	Randomized , controlled trial .
-METHODS	Eight medicine units ( Barnes-Jewish Hospital ) .
-METHODS	Five hundred seventy-one patients .
-METHODS	Real-time alerts generated by a validated deterioration algorithm were sent real-time to the RRT ( intervention ) or hidden ( control ) .
-METHODS	Intensive care unit ( ICU ) transfer , hospital mortality , hospital duration .
-RESULTS	ICU transfer ( 17.8 % vs 18.2 % ; odds ratio : 0.972 ; 95 % confidence interval [ CI ] : 0.635-1 .490 ) and hospital mortality ( 7.3 % vs 7.7 % ; odds ratio : 0.947 ; 95 % CI : 0.509-1 .764 ) were similar for the intervention and control groups .
-RESULTS	The number of patients requiring transfer to a nursing home or long-term acute care hospital was similar for patients in the intervention and control groups ( 26.9 % vs 26.3 % ; odds ratio : 1.032 ; 95 % CI : 0.712-1 .495 ) .
-RESULTS	Hospital duration ( 8.49.5 days vs 9.411.1 days ; P = 0.038 ) was statistically shorter for the intervention group .
-RESULTS	The number of RRT calls initiated by the primary care team was similar for the intervention and control groups ( 19.9 % vs 16.5 % ; odds ratio : 1.260 ; 95 % CI : 0.823-1 .931 ) .
-CONCLUSIONS	Real-time alerts sent to the RRT did not reduce ICU transfers , hospital mortality , or the need for subsequent long term care .
-CONCLUSIONS	However , hospital length of stay was modestly reduced .
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-###25362513
-BACKGROUND	Insufficient fasting prior to endoscopic procedures performed under sedation may result in potential aspiration of gastric contents .
-BACKGROUND	Fasting as per ASA guidelines is recommended prior to these procedures .
-BACKGROUND	However , the effect of chewing gum on fasting status has been a subject of debate and often leads to procedural delays .
-OBJECTIVE	Evaluation of the effect of chewing gum on the gastric volume and pH.
-METHODS	In this randomized controlled prospective observer blinded trail , ASA I-III patients aged more than 18 years scheduled for esophagogastroduodenoscopy ( EGD ) or a combined EGD and colonoscopy under conscious sedation were studied .
-METHODS	Patients randomized to the chewing gum group ( Group-C ) were allowed to chew gum until just before the start of their procedure ; the remaining patients were included into Group-NC .
-METHODS	After sedation and endoscope insertion , stomach contents were aspirated under vision of a gastroenterologist ( blinded to groups ) .
-RESULTS	Volume and pH of gastric contents aspirated from 67 patients ( 34 in Group-C and 33 in Group-NC ) were analyzed .
-RESULTS	The demographic parameters of the groups were comparable .
-RESULTS	Gastric volume ( median-interquartile range ) was statistically higher in Group-C ( 13 ml ( 7.75-40 .75 ) vs Group-NC 6 ml ( 1.00-14 .00 ) ( P < 0.001 ) ] .
-RESULTS	The mean pH in both groups was comparable : 2.84 2.11 in Group-C and 3.79 2.53 in Group-NC ( P = 0.141 ) .
-CONCLUSIONS	Although our results show gastric volume in patients chewing gum was statistically higher , clinical relevance of such a small difference is questionable .
-CONCLUSIONS	Thus patients who chewed gum inadvertently prior to procedure should not be denied or delayed administration of sedative and anesthetic medications .
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-###25281778
-OBJECTIVE	Bladder dysfunction influences recovery of urinary continence after radical prostatectomy .
-OBJECTIVE	We performed a multicenter , randomized , double-blind study evaluating solifenacin vs placebo on return to continence in patients who were still incontinent 7 to 21 days after catheter removal after robot-assisted radical prostatectomy .
-METHODS	A wireless personal digital assistant was given to patients the day of catheter removal .
-METHODS	Encrypted answers were transmitted daily to dedicated servers .
-METHODS	After a 7 to 21-day treatment-free washout period , patients requiring 2 to 10 pads per day for 7 consecutive days were randomized ( 1:1 ) to 5 mg solifenacin daily or placebo .
-METHODS	The primary end point was time from first dose to continence defined as 0 pads per day or a dry security pad for 3 consecutive days .
-METHODS	Secondary end points included proportion of patients continent at end of study , average change in pads per day number and quality of life assessments .
-RESULTS	A total of 1,086 screened patients recorded personal digital assistant information .
-RESULTS	Overall 640 patients were randomized to solifenacin vs placebo and 17 failed to take medication .
-RESULTS	There was no difference in time to continence ( p = 0.17 ) .
-RESULTS	Continence was achieved by study end in 91 of 313 ( 29 % ) vs 66 of 309 ( 21 % ) , respectively ( p = 0.04 ) .
-RESULTS	Pads per day change from baseline was -3.2 and -2.9 , respectively ( p = 0.03 ) .
-RESULTS	Dry mouth was the only common adverse event seen in 6.1 % and 0.6 % , respectively .
-RESULTS	Constipation rates were similar .
-RESULTS	The overall rate of continence in the entire population from screening to end of study was 73 % .
-CONCLUSIONS	There was no effect on primary outcome but some secondary end points benefited the solifenacin arm .
-CONCLUSIONS	The study provides level 1B clinical evidence for continence outcomes after robot-assisted radical prostatectomy .
-
-###25516423
-BACKGROUND	Sickness absence due to poor mental health is a common problem in many Western countries .
-BACKGROUND	To facilitate return to work , it may be important to identify individuals on sick leave and at risk of having a mental disorder and subsequently to offer appropriate treatment .
-BACKGROUND	Psychoeducation alone has not previously been used as a return to work intervention , but may be a promising tool to facilitate return to work .
-BACKGROUND	Therefore , the aim of the study is to evaluate the effectiveness of psychoeducation designed specifically to facilitate return to work for individuals on sick leave and at risk of having a mental disorder .
-BACKGROUND	The psychoeducation was a supplement to the various standard offers provided by the job centres .
-METHODS	The study is a randomised controlled trial , in which individuals on sick leave either receive psychoeducation and standard case management or standard case management alone .
-METHODS	Participants were individuals with mental health symptoms , who had been on sick leave from part-time or full-time work or unemployment for about 4-8 weeks .
-METHODS	The psychoeducational intervention was group-based and the course consisted of 2 hour sessions once a week for 6 weeks .
-METHODS	The course was given by psychiatric nurses , a psychologist , a social worker , a physiotherapist and a person who had previously been on sick leave due to mental health problems .
-METHODS	The sessions focused on stress and work life , and the purpose was to provide individuals on sick leave the skills to understand and improve their mental functioning.The primary outcome is the duration of sickness absence measured by register data .
-METHODS	Secondary outcomes include psychological symptoms , mental health-related quality of life , and locus of control .
-METHODS	These outcomes are measured by questionnaires at the start of the intervention and at 3 and 6 months follow-up .
-CONCLUSIONS	On the basis of this trial , the effect of psychoeducation for individuals on sick leave and at risk of having a mental disorder will be studied .
-CONCLUSIONS	The results will contribute to the continuing research on sickness absence and mental health .
-CONCLUSIONS	It will primarily show whether psychoeducation can lead to faster and sustainable return to work .
-BACKGROUND	Clinical Trial.gov NCT01637363 .
-BACKGROUND	Registered 6 July 2012 .
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-###25260444
-OBJECTIVE	To evaluate if addition of L-carnitine therapy to standard varicocelectomy adds any extra benefit in terms of improvement in semen parameters or deoxyribonucleic acid ( DNA ) damage .
-METHODS	One hundred patients enrolled in this study and were randomly divided into 2 groups ( 50 patients in each group ) .
-METHODS	In group 1 , standard inguinal varicocelectomy and , in group 2 , standard inguinal varicocelectomy plus oral antioxidant therapy ( oral L-carnitine , 250 mg 3 times a day ) were performed for 6 months .
-METHODS	For all patients , routine semen analysis and DNA damage test of spermatozoa ( by 2 methods of terminal deoxynucleotidyl transferase dUTP nick end labeling and protamine damage assay ) were performed at baseline and at 3 and 6 months postoperatively .
-RESULTS	In both groups , the improvement in semen analysis parameters and DNA damage was observed , but there was not any statistically significant difference between the 2 groups in these parameters , although the slope of improvement in DNA damage was slightly better in group 2 ( that was not statistically significant ) .
-CONCLUSIONS	We observed that addition of 750 mg of L-carnitine orally daily to standard inguinal varicocelectomy does not add any extra benefit in terms of improvement in semen analysis parameters or DNA damage .
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-###25534375
-OBJECTIVE	Modulation of immunologic interactions in cancer tissue is a promising therapeutic strategy .
-OBJECTIVE	To investigate the immunogenicity of human epidermal growth factor receptor 2 ( HER2 ) - positive and triple-negative ( TN ) breast cancers ( BCs ) , we evaluated tumor-infiltrating lymphocytes ( TILs ) and immunologically relevant genes in the neoadjuvant GeparSixto trial .
-METHODS	GeparSixto investigated the effect of adding carboplatin ( Cb ) to an anthracycline-plus-taxane combination ( PM ) on pathologic complete response ( pCR ) .
-METHODS	A total of 580 tumors were evaluated before random assignment for stromal TILs and lymphocyte-predominant BC ( LPBC ) .
-METHODS	mRNA expression of immune-activating ( CXCL9 , CCL5 , CD8A , CD80 , CXCL13 , IGKC , CD21 ) as well as immunosuppressive factors ( IDO1 , PD-1 , PD-L1 , CTLA4 , FOXP3 ) was measured in 481 tumors .
-RESULTS	Increased levels of stromal TILs predicted pCR in univariable ( P < .001 ) and multivariable analyses ( P < .001 ) .
-RESULTS	pCR rate was 59.9 % in LPBC and 33.8 % for non-LPBC ( P < .001 ) .
-RESULTS	pCR rates 75 % were observed in patients with LPBC tumors treated with PMCb , with a significant test for interaction with therapy in the complete ( P = .002 ) and HER2-positive ( P = .006 ) , but not the TNBC , cohorts .
-RESULTS	Hierarchic clustering of mRNA markers revealed three immune subtypes with different pCR rates ( P < .001 ) .
-RESULTS	All 12 immune mRNA markers were predictive for increased pCR .
-RESULTS	The highest odds ratios ( ORs ) were observed for PD-L1 ( OR , 1.57 ; 95 % CI , 1.34 to 1.86 ; P < .001 ) and CCL5 ( OR , 1.41 ; 95 % CI , 1.23 to 1.62 ; P < .001 ) .
-CONCLUSIONS	Immunologic factors were highly significant predictors of therapy response in the GeparSixto trial , particularly in patients treated with Cb .
-CONCLUSIONS	After further standardization , they could be included in histopathologic assessment of BC .
-
-###25833230
-BACKGROUND	Randomized studies of adjuvant chemotherapy using gemcitabine suggest a survival benefit after resection of pancreatic cancer .
-BACKGROUND	S-1 has also been shown to prolong survival in patients with unresectable pancreatic cancer .
-BACKGROUND	This study compared the effects of adjuvant chemotherapy with S-1 or gemcitabine after resection of pancreatic cancer in a randomized trial .
-METHODS	Patients who had undergone resection of pancreatic cancer were registered in this randomized clinical trial .
-METHODS	The primary endpoint was disease-free survival ( DFS ) .
-METHODS	Expression levels of thymidylate synthase ( TS ) and dihydropyrimidine dehydrogenase ( DPD ) mRNAs in cancer tissues were measured as indicators of fluoropyrimidine sensitivity .
-RESULTS	Of 57 patients registered , 29 were allocated to the S-1 group and 28 to gemcitabine .
-RESULTS	DFS tended to be better with S-1 ( median 146 ( 90 per cent c.i. 88 to 284 ) months versus 105 ( 70 to 284 ) months in the gemcitabine group ; P = 0188 ) , with a similar pattern for overall survival : 215 ( 95 per cent c.i. 144 to 423 ) and 180 ( 133 to 428 ) months respectively ( P = 0293 ) .
-RESULTS	When patients were divided into subgroups based on high or low DPD and TS expression , those with a DPD level below the median of 088 or a TS level of at least 200 had a significant prolongation of DFS after S-1 treatment compared with gemcitabine ( P = 0008 and P = 0035 respectively ) .
-CONCLUSIONS	Overall , S-1 did not improve DFS compared with gemcitabine after pancreatic cancer resection , but there seemed to be a DFS advantage in patients with low expression of DPD or high expression of TS .
-CONCLUSIONS	Reference number : UMIN000009118 ( http://www.umin.ac.jp/ctr/ ) .
-
-###24795092
-BACKGROUND	We conducted a randomized controlled trial to evaluate the clinical efficacy and safety of intravenous doripenem ( DRPM ) in patients with biliary tract infection requiring biliary drainage in comparison with imipenem/cilastatin ( IPM/CS ) .
-METHODS	After the initial collection of bile , patients were randomly assigned by the registration system of the Clinical Research Organization to receive intravenous drip infusion of DRPM 0.5 g or IPM/CS 0.5 g three times daily in a randomized , open-label manner .
-RESULTS	A total of 127 patients were enrolled in the trial ( DRPM 62 , IPM/CS 65 ) .
-RESULTS	The characteristics of the 122 patients evaluated for efficacy were well balanced , except for the percentage of patients previously receiving antimicrobials , which was higher in the DRPM group than in the IPM/CS group .
-RESULTS	The clinical response rate was not significantly different between the DRPM group ( 93.1 % , 54/58 patients ) and the IPM/CS group ( 93.8 % , 60/64 ) .
-RESULTS	Non-inferiority assessment using confidence intervals demonstrated the non-inferiority of DRPM-IPM/CS .
-RESULTS	The incidence of adverse events , for which a causal relationship with either treatment was not ruled out , was 3.3 % ( 2/60 ) in the DRPM group and 3.1 % ( 2/65 ) in the IPM/CS group , and none was serious .
-CONCLUSIONS	The clinical efficacy of DRPM in treating moderate or severe biliary tract infection requiring drainage was comparable to that of IPM/CS .
-CONCLUSIONS	DRPM was associated with no serious adverse events and a low incidence of adverse events .
-CONCLUSIONS	The results of this trial demonstrate that DRPM is a useful therapeutic option for moderate or severe biliary tract infection .
-
-###24560483
-OBJECTIVE	Our randomized trial compared early and delayed intrauterine device ( IUD ) insertion following medical abortion .
-OBJECTIVE	In this planned substudy , we explore if endometrial thickness and initial IUD position were associated with IUD expulsion .
-OBJECTIVE	We also describe IUD movement within the uterus during the 6 months after insertion .
-METHODS	We recruited women undergoing medical abortion and choosing the copper IUD for contraception ( n = 156 ) .
-METHODS	Participants were randomly assigned to early insertion 1 week after mifepristone or delayed insertion 4-6 weeks later .
-METHODS	We measured endometrial thickness by transvaginal sonogram 1 week after abortion and IUD distance from the fundal aspect of the endometrial cavity three times : at insertion , 6-8 weeks later and at 6 months .
-RESULTS	We analyzed endometrial thickness in 113 women , baseline IUD position in 114 women and IUD movement in 65 women .
-RESULTS	Women who expelled IUDs ( n = 15 ) had slightly thicker endometria ( p = .007 ) and slightly lower baseline IUD positions ( p = .03 ) than those who retained IUDs , but no clear cutoffs emerged in the receiver operating characteristic curve analysis .
-RESULTS	Retained IUDs commonly moved up and down throughout the 6 months ( from 14 mm towards the fundus to 32 mm towards the cervix ) .
-RESULTS	Overall , retained IUDs moved a median of 2mm towards the cervix between insertion and exit ( p < .0001 ) .
-CONCLUSIONS	After medical abortion , the risk of IUD expulsion increases with thicker endometria and lower baseline position .
-CONCLUSIONS	Since no clear cutoffs emerged in the analysis and expulsion remained uncommon even with thicker endometria , we do not recommend restricting IUD insertion based on ultrasound data .
-CONCLUSIONS	Copper T IUDs often move within the uterus without expelling .
-CONCLUSIONS	Expulsion is uncommon , and we do not recommend restricting IUD insertion based on ultrasound data .
-
-###24655714
-BACKGROUND	Previous studies observed the surprising finding that saturated fat was inversely associated with atherosclerosis progression in postmenopausal women , whereas polyunsaturated fat ( PUFA ) and carbohydrates were positively associated .
-BACKGROUND	Whether certain genes modify the association of diet with atherosclerotic progression is unknown .
-METHODS	Using Haplotype-tagging single nucleotide polymorphisms , we evaluated gene-diet interactions with 3 preselected genes involved in fatty acid and carbohydrate metabolism : sterol regulatory element binding protein-1 ( SREBP1 ) , insulin-induced gene-1 ( INSIG1 ) , and SREBP cleavage-activating protein ( SCAP ) .
-METHODS	Diet was assessed at baseline .
-METHODS	Quantitative coronary angiography was performed at baseline and after a mean of follow-up of 3.09 years in 2,227 coronary segments in 234 postmenopausal women .
-RESULTS	Global effects of each gene and gene-diet interactions for different fats , total fat , and carbohydrate were evaluated .
-RESULTS	Global tests revealed no main effects between SCAP , INSIG1 , and SREBP1 haplotypes and progression of atherosclerosis ( P = .87 , P = .58 , and P = .44 ) .
-RESULTS	After correction for 5 nutrients evaluated ( Bonferroni-corrected 2-tailed = .01 ) , no significant gene-nutrient interactions were seen , except for a borderline global interaction between SREBP1 and PUFA intake ( P interaction = .013 ) .
-RESULTS	This interaction was specific to the G-C haplotype ( frequency 35 % ) and was driven by n-6 rather than n-3 PUFA ( P for interaction < .0001 ) .
-RESULTS	The interaction was robust to estimated isocaloric replacement of PUFA with any other nutrient .
-RESULTS	Per each 5 % energy from n-6 PUFA , a 0.21-mm greater decline in mean minimal coronary artery diameter was seen among women per each copy of the second most frequent haplotype of SREBP1 .
-CONCLUSIONS	We observed an interaction between SREBP1 and PUFA consumption that might explain the positive association of PUFA with atherosclerosis progression in this cohort .
-
-###24628682
-OBJECTIVE	In spite of the major focus on risky , single-occasion drinking by young people in Australia , little is known about the specific circumstances of risky drinking occasions .
-OBJECTIVE	This study examines drinking behaviours and drinking contexts for the most recent risky , single-occasion drinking episode in a representative sample of young risky drinkers in Victoria , Australia .
-METHODS	A representative sample of 802 young risky drinkers was recruited across metropolitan Melbourne and surveyed about their drinking and related behaviours .
-METHODS	Specific questions focused on participants ' most recent high-risk ( > 10 Australian standard drinks for males , > 7 Australian standard drinks for females ) drinking occasion in terms of self-reported amount drunk , alcohol expenditure ( including buying rounds ) and drinking partners for up to 10 different drinking settings .
-RESULTS	Participants reported drinking a mean of 13 Australian standard drinks on their last episode of risky , single-occasion drinking ; for half of the participants , this occurred less than 20 days prior to being surveyed .
-RESULTS	The majority ( 62 % ) of risky single occasion drinking sessions commenced at private homes in the company of close friends ( 81 % ) .
-RESULTS	Around 40 % of the sample reported going to one ( 42 % ) or two ( 37 % ) drinking locations , and only 5 % reported going to more than three drinking locations .
-CONCLUSIONS	Contrary to public portrayals , a significant amount of risky drinking by young people occurs in private settings .
-CONCLUSIONS	These contexts are rarely mentioned except in relation to underage drinking .
-CONCLUSIONS	Further work is needed to understand how these drinking behaviours and contexts link to harm .
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-###25378913
-OBJECTIVE	We aimed to investigate the influence of perioperative goal-directed fluid therapy ( GDFT ) on the prognosis of elderly patients with gastric cancer and hypertension .
-METHODS	Sixty elderly patients ( > 60 years old ) with primary hypertension who received gastric cancer radical surgery and who were American Society of Anesthesiologists ( ASA ) class II or III were enrolled in the current study .
-METHODS	Selected patients were divided randomly into two arms , comprising a conventional intraoperative fluid management arm ( arm C , n = 30 ) and a GDFT arm ( arm G , n = 30 ) .
-METHODS	Patients in arm C were infused with crystalloids or colloids according to the methods of Miller 's Anesthesia ( 6th edition ) , while those in arm G were infused with 200 mL hydroxyethyl starch over 15 minutes under the FloTrac/Vigileo monitoring system , with stroke volume variation between 8 % and 13 % .
-METHODS	Hemodynamics and tissue perfusion laboratory indicators in patients were recorded continuously from 30 minutes before the operation to 24 hours after the operation .
-RESULTS	Compared with arm C , the average intraoperative intravenous infusion quantity in arm G was significantly reduced ( 2,732488 mL versus 3,135346 mL , P < 0.05 ) , whereas average colloid fluid volume was significantly increased ( 1,235360 mL versus 760280 mL , P < 0.05 ) .
-RESULTS	In addition , there were more patients exhibiting intraoperatively and postoperatively stable hemodynamics and less patients with low blood pressure in arm G. Postoperative complications were less frequent , and the time of postoperative hospital stay shorter , in arm G. No significant differences were observed in mortality between the two arms .
-CONCLUSIONS	Our research showed that GDFT stabilized perioperative hemodynamics and reduced the occurrence of postoperative complications in elderly patients who underwent gastric cancer surgery .
-
-###24773567
-BACKGROUND	Health assessment and medical surveillance of workers exposed to combustion nanoparticles are challenging .
-BACKGROUND	The aim was to evaluate the feasibility of using exhaled breath condensate ( EBC ) from healthy volunteers for ( 1 ) assessing the lung deposited dose of combustion nanoparticles and ( 2 ) determining the resulting oxidative stress by measuring hydrogen peroxide ( H ( 2 ) O ( 2 ) ) and malondialdehyde ( MDA ) .
-METHODS	Fifteen healthy nonsmoker volunteers were exposed to three different levels of sidestream cigarette smoke under controlled conditions .
-METHODS	EBC was repeatedly collected before , during , and 1 and 2hr after exposure .
-METHODS	Exposure variables were measured by direct reading instruments and by active sampling .
-METHODS	The different EBC samples were analyzed for particle number concentration ( light-scattering-based method ) and for selected compounds considered oxidative stress markers .
-RESULTS	Subjects were exposed to an average airborne concentration up to 4.310 ( 5 ) particles/cm ( 3 ) ( average geometric size 60-80nm ) .
-RESULTS	Up to 1010 ( 8 ) particles/mL could be measured in the collected EBC with a broad size distribution ( 50 ( th ) percentile 160nm ) , but these biological concentrations were not related to the exposure level of cigarette smoke particles .
-RESULTS	Although H ( 2 ) O ( 2 ) and MDA concentrations in EBC increased during exposure , only H2O2 showed a transient normalization 1hr after exposure and increased afterward .
-RESULTS	In contrast , MDA levels stayed elevated during the 2hr post exposure .
-CONCLUSIONS	The use of diffusion light scattering for particle counting proved to be sufficiently sensitive to detect objects in EBC , but lacked the specificity for carbonaceous tobacco smoke particles .
-CONCLUSIONS	Our results suggest two phases of oxidation markers in EBC : first , the initial deposition of particles and gases in the lung lining liquid , and later the start of oxidative stress with associated cell membrane damage .
-CONCLUSIONS	Future studies should extend the follow-up time and should remove gases or particles from the air to allow differentiation between the different sources of H ( 2 ) O ( 2 ) and MDA .
-
-###25533903
-OBJECTIVE	Chronic heart failure ( CHF ) patients often present with ( pre ) diabetes , which negatively influences prognosis .
-OBJECTIVE	Unlike the proven effect of exercise on glucose regulation in the general population , its effect in CHF is unclear .
-OBJECTIVE	Therefore , this study aimed at investigating the effect of exercise training on glucose regulation in stable CHF patients .
-METHODS	Twenty-two CHF patients were randomized into training ( EX , n = 15 ) and control ( CON , n = 7 ) groups .
-METHODS	Before and after a 12-week training intervention involving endurance and resistance training , glucose tolerance ( 2-hour oral glucose tolerance test ) , exercise tolerance ( cardiopulmonary exercise test ) , muscle strength ( isokinetic dynamometer ) , heart function ( echocardiography ) , glycated hemoglobin , body composition ( dual-energy x-ray absorptiometry ) , and quality of life ( EQ5D ) were assessed .
-RESULTS	At baseline , glucose levels 2 hours after glucose intake were elevated in both groups .
-RESULTS	Whereas area under the glucose curve did not change , area under the insulin curve decreased following training ( EX , -13 23 % vs CON , +22 33 % ; P < .05 ) .
-RESULTS	Changes in the ratio of mitral peak velocity of early filling/early diastolic mitral annular velocity and waist-to-hip fat mass ratio were related to changes in the insulin curve .
-RESULTS	Exercise training resulted in improved oxygen uptake at the second ventilatory threshold ( EX , +10 5 % vs CON , -8 5 % ; P < .05 ) and isokinetic strength endurance of the upper leg ( EX , +25 9 % vs CON , -6 5 % ; P < 0.05 ) .
-RESULTS	Lean body tissue was increased by 2.2 0.5 % in EX versus 0.2 0.6 % in CON ( P < .05 ) .
-CONCLUSIONS	Our data suggest that exercise training attenuates worsening of glucose regulation typically seen in a stable CHF population .
-
-###24961493
-OBJECTIVE	Low systolic blood pressure ( SBP ) is associated with poor outcomes in heart failure and complicates management .
-OBJECTIVE	In a post hoc analysis , we investigated the efficacy and safety of ivabradine in the SHIFT population divided by tertiles of baseline SBP .
-RESULTS	The analysis comprised 2110 patients with SBP < 115 mmHg , 1968 with 115 SBP < 130 mmHg , and 2427 with SBP 130 mmHg .
-RESULTS	Patients with low SBP were younger , had lower ejection fraction , and were less likely to be at target beta-blocker dose than patients in the other SBP groups .
-RESULTS	Ivabradine was associated with a similar relative risk reduction of the composite outcome in the three SBP groups [ SBP < 115 mmHg , hazard ratio ( HR ) = 0.84 , 95 % confidence interval ( CI ) 0.72-0 .98 ; 115 SBP < 130 mmHg , HR = 0.86 , 95 % CI 0.72 to 1.03 ; SBP 130 mmHg , HR = 0.77 , 95 % CI 0.66 to 0.92 ; P interaction = 0.68 ] .
-RESULTS	Similar results were found for cardiovascular mortality ( P interaction = 0.91 ) , hospitalization because of heart failure ( P interaction = 0.79 ) , all-cause mortality ( P interaction = 0.90 ) , and heart failure mortality ( P interaction = 0.18 ) .
-RESULTS	There was no evidence for a difference in safety profile according to SBP group .
-CONCLUSIONS	The efficacy and safety of ivabradine is independent of SBP .
-CONCLUSIONS	This may have implications for the management of HF patients with low SBP and elevated heart rate .
-
-###25881936
-BACKGROUND	Studies demonstrate that lowering low-density lipoprotein cholesterol ( LDL-C ) using a statin is associated with significant reduction in cardiovascular events .
-BACKGROUND	Whether visit-to-visit variability in LDL-C levels affects cardiovascular outcomes is unknown .
-OBJECTIVE	This study sought to evaluate the role of visit-to-visit variability in LDL-C levels on cardiovascular outcomes .
-METHODS	We evaluated patients with coronary artery disease and LDL-C < 130 mg/dl enrolled in the TNT ( Treating to New Targets ) trial , randomly assigned to receive atorvastatin 80 mg/day versus 10 mg/day and with at least one post-baseline measurement of LDL-C .
-METHODS	Visit-to-visit LDL-C variability was evaluated from 3 months into random assignment through the use of various measurements of LDL-C variability : SD , average successive variability ( ASV ) , coefficient of variation , and variation independent of mean , with the first 2 measurements used as the primary measurements .
-METHODS	Primary outcome was any coronary event , and secondary outcomes were any cardiovascular event , death , myocardial infarction , or stroke .
-RESULTS	Among 9,572 patients , SD and ASV were significantly lower with atorvastatin 80 mg/day versus 10 mg/day ( SD : 12.03 9.70 vs. 12.52 7.43 ; p = 0.005 ; ASV : 12.84 10.48 vs. 13.76 8.69 ; p < 0.0001 ) .
-RESULTS	In the adjusted model , each 1-SD increase in LDL-C variability ( by ASV ) increased the risk of any coronary event by 16 % ( hazard ratio [ HR ] : 1.16 ; 95 % confidence interval [ CI ] : 1.10 to 1.23 ; p < 0.0001 ) , any cardiovascular event by 11 % ( HR : 1.11 ; 95 % CI : 1.07 to 1.15 ; p < 0.0001 ) , death by 23 % ( HR : 1.23 ; 95 % CI : 1.14 to 1.34 ; p < 0.0001 ) , myocardial infarction by 10 % ( HR : 1.10 ; 95 % CI : 1.02 to 1.19 ; p = 0.02 ) , and stroke by 17 % ( HR : 1.17 ; 95 % CI : 1.04 to 1.31 ; p = 0.01 ) , independent of treatment effect and achieved LDL-C levels .
-RESULTS	Results were largely consistent when adjusted for medication adherence .
-CONCLUSIONS	In subjects with coronary artery disease , visit-to-visit LDL-C variability is an independent predictor of cardiovascular events .
-
-###24754318
-OBJECTIVE	To evaluate whether vagus nerve stimulation ( VNS ) as adjunct to best medical practice ( VNS + BMP ) is superior to BMP alone in improving long-term health-related quality of life ( HRQoL ) .
-METHODS	PuLsE ( Open Prospective Randomized Long-term Effectiveness ) was a prospective , randomized , parallel-group , open-label , and long-term effectiveness study ( conducted at 28 sites in Europe and Canada ) .
-METHODS	Adults with pharmacoresistant focal seizures ( n = 112 ) received VNS + BMP or BMP ( 1:1 ratio ) .
-METHODS	Medications and VNS parameters could be adjusted as clinically indicated for optimal seizure control while minimizing adverse effects .
-METHODS	Primary endpoint was mean change from baseline HRQoL ( using Quality of Life in Epilepsy Inventory-89 total score ; QOLIE-89 ) .
-METHODS	Secondary endpoints included changes in seizure frequency , responder rate ( 50 % decrease in seizure frequency ) , Centre for Epidemiologic Studies Depression scale ( CES-D ) , Neurological Disorders Depression Inventory-Epilepsy scale ( NDDI-E ) , Clinical Global Impression-Improvement scale ( CGI-I ) , Adverse Event Profile ( AEP ) , and antiepileptic drug ( AED ) load .
-METHODS	The study was prematurely terminated due to recruitment difficulties prior to completing the planned enrollment of n = 362 .
-METHODS	Results for n = 96 who had baseline and at least one follow-up QOLIE-89 assessment ( from months 3-12 ) were included in this analysis .
-METHODS	Mixed model repeated measures ( MMRM ) analysis of variance was performed on change from baseline for the primary and secondary endpoints .
-RESULTS	Significant between-group differences in favor of VNS + BMP were observed regarding improvement in HRQoL , seizure frequency , and CGI-I score ( respective p-values < 0.05 , 0.03 , and 0.01 ) .
-RESULTS	More patients in the VNS + BMP group ( 43 % ) reported adverse events ( AEs ) versus BMP group ( 21 % ) ( p = 0.01 ) , a difference reflecting primarily mostly transient AEs related to VNS implantation or stimulation .
-RESULTS	No significant difference between treatment groups was observed for changes in CES-D , NDDI-E , AEP , and AED load .
-CONCLUSIONS	VNS therapy as a treatment adjunct to BMP in patients with pharmacoresistant focal seizures was associated with a significant improvement in HRQoL compared with BMP alone .
-CONCLUSIONS	A PowerPoint slide summarizing this article is available for download in the Supporting Information section here .
-
-###25603802
-BACKGROUND	The MGuard , a bare metal stent covered with a polymer mesh , was designed to reduce distal embolization during percutaneous coronary intervention in ST-segment-elevation myocardial infarction .
-BACKGROUND	In the MGUARD for Acute ST Elevation Reperfusion trial , the primary end point of complete ST-segment resolution was significantly improved with the MGuard compared with control .
-BACKGROUND	We evaluated 1-year clinical and angiographic results .
-RESULTS	Patients with ST-segment-elevation myocardial infarction 12 hours undergoing primary percutaneous coronary intervention of a single de novo native lesion were randomized to the MGuard versus any commercially available metallic stent ( 39.8 % drug-eluting ) .
-RESULTS	Clinical follow-up was performed through 1 year , and angiography at 13 months was planned in 50 MGuard patients .
-RESULTS	There was no difference in major adverse cardiac events ( 1.8 % versus 2.3 % ; P = 0.75 ) at 30 days between the groups .
-RESULTS	Major adverse cardiac events at 1 year were higher with the MGuard , driven by greater ischemia-driven target lesion revascularization ( 8.6 % versus 0.9 % ; P = 0.0003 ) .
-RESULTS	Conversely , mortality tended to be lower with the MGuard at 30 days ( 0 % versus 1.9 % ; P = 0.04 ) and at 1 year ( 1.0 % versus 3.3 % ; P = 0.09 ) .
-RESULTS	Late lumen loss at 13 months in the MGuard was 0.990.80 mm , and binary restenosis was 31.6 % .
-CONCLUSIONS	In patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention , a trend toward reduced 1-year mortality was present in patients treated with the MGuard stent .
-CONCLUSIONS	Target lesion revascularization and major adverse cardiac events rates during follow-up were higher in the MGuard group than in the control stent group , and angiographic late loss of the MGuard was consistent with that expected from bare metal stents .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01368471 .
-
-###24889392
-BACKGROUND	L-ornithine is a non-essential , non-protein amino acid .
-BACKGROUND	Although L-ornithine is contained in various foods , the amount is usually small.Recently , studies have shown that orally administered L-ornithine reduced the stress response in animals.From these findings , we speculated that L-ornithine may play a role in the relieve of stress and improve sleep and fatigue symptoms in humans .
-BACKGROUND	Through a randomised , double-blind , placebo-controlled clinical study , we asked if L-ornithine could be beneficial to stress and sleep in healthy workers .
-METHODS	Fifty-two apparently healthy Japanese adults who had previously felt slight stress as well as fatigue were recruited to be study participants and were randomly divided into either the L-ornithine ( 400 mg/day ) or placebo group .
-METHODS	They orally consumed the respective test substance every day for 8 weeks .
-METHODS	Serum was collected for the assessment of cortisol and dehydroepiandrosterone-sulphate ( DHEA-S ) .
-METHODS	Perceived mood and quality of sleep were measured by the Profile of Mood States ( POMS ) , Athens Insomnia Scale ( AIS ) , and Ogri-Shirakawa-Azumi sleep inventory MA version ( OSA-MA ) .
-RESULTS	Serum cortisol levels and the cortisol/DHEA-S ratio were significantly decreased in the L-ornithine group in comparison with the placebo group .
-RESULTS	Also , anger was reduced and perceived sleep quality was improved in the L-ornithine group .
-CONCLUSIONS	L-ornithine supplementation has the potential to relieve stress and improve sleep quality related to fatigue , both objectively and subjectively .
-
-###25002722
-OBJECTIVE	Development of new therapies for previously treated small-cell lung cancer ( SCLC ) is a major unmet need .
-OBJECTIVE	Here , we describe a randomized , phase II trial of weekly topotecan with or without ziv-aflibercept ( VEGF-trap ) in this clinical setting .
-METHODS	Patients with previously treated SCLC ( one line of platinum-based chemotherapy ) , performance status of 0 to 1 , adequate organ function , treated brain metastases , and no recent vascular events or bleeding diatheses were eligible .
-METHODS	Eligible patients were stratified as platinum-sensitive or platinum-refractory and randomly assigned to receive weekly topotecan 4 mg/m ( 2 ) intravenously ( IV ) with or without ziv-aflibercept 6 mg/kg IV every 21 days .
-METHODS	Progression-free survival ( PFS ) at 3 months was the primary end point .
-RESULTS	In 189 randomly assigned patients , treatment arms were well balanced with regard to clinical characteristics .
-RESULTS	The 3-month PFS was significantly improved with the addition of ziv-aflibercept in patients who had platinum-refractory disease ( 27 % v 10 % ; P = .02 ) but not in patients with platinum-sensitive disease ( 24 % v 15 % ; P = .22 ) .
-RESULTS	Although response rate was low , disease control rate was higher with combination therapy than with topotecan alone in patients who had platinum-sensitive disease ( 37 % v 18 % ; P = .05 ) and in those who had platinum-refractory disease ( 25 % v 15 % ; P = .14 ) .
-RESULTS	Overall survival ( OS ) was not significantly improved in either strata .
-RESULTS	Grades 3 to 5 toxicities were more common with the addition of ziv-aflibercept .
-CONCLUSIONS	Ziv-aflibercept improved the 3-month PFS in patients who had platinum-refractory SCLC , but its addition increased toxicity .
-CONCLUSIONS	OS was similar with combined ziv-aflibercept and topotecan compared with topotecan in both strata .
-
-###25062810
-BACKGROUND	Late enhancement MRI ( LE-MRI ) and cardiac troponin I ( cTnI ) are sensitive methods to detect subclinical myocardial injury .
-BACKGROUND	We sought to investigate the relation between plasma concentrations of cTnI measured with a high-sensitivity assay ( hs-cTnI ) and the development of unrecognized myocardial infarctions ( UMIs ) detected with LE-MRI .
-METHODS	After approval from the ethics committee and written informed consent were obtained , LE-MRI was performed on 248 randomly selected community-living 70-year-old volunteers and hs-cTnI was determined with a highly sensitive premarket assay .
-METHODS	Five years later these individuals were invited to a second LE-MRI , and 176 of them ( 82 women , 94 men ) , who did not have a hospital diagnosis of MI , constitute the present study population .
-METHODS	LE-MR images were analyzed by 2 radiologists independently and in a consensus reading , blinded to any information on previous disease or assessments .
-RESULTS	New or larger UMIs were detected in 37 participants during follow-up .
-RESULTS	Plasma concentrations of hs-cTnI at 70 years of age , which were mainly within what is considered to be the reference interval , were related to new or larger UMIs at 75 years of age with an odds ratio of 1.98 per 1 unit increase in ln-transformed cTnI ( 95 % CI , 1.17-3 .35 ; P = 0.010 ) .
-RESULTS	Plasma concentrations of hs-cTnI at 70 years of age were associated with the volumes of the UMIs detected at 75 years of age ( P = 0.028 ) .
-CONCLUSIONS	hs-cTnI in 70-year-old community-living women and men was associated with the development of MRI-detected UMIs within 5 years .
-
-###24594552
-BACKGROUND	The Relaxin for the Treatment of Acute Heart Failure ( RELAX-AHF ) trial enrolled 1161 patients admitted to the hospital for acute heart failure ( AHF ) to evaluate the therapeutic efficacy of serelaxin , a recombinant form of human relaxin-2 .
-BACKGROUND	We characterized how representative RELAX-AHF clinical trial enrollees were to those patients with AHF found in international registries .
-RESULTS	We examined 196 770 AHF admissions from the Acute Decompensated Heart Failure National Registry-United States and Acute Decompensated Heart Failure National Registry-International registries .
-RESULTS	Patients were considered RELAX-AHF-type if they met the following criteria : discharge diagnosis of heart failure , systolic blood pressure > 125 mm Hg , dyspnea at rest or with mild exertion , intravenous diuretic use , glomerular filtration rate of 30 to 75 mL/min per 1.73 m ( 2 ) , hemoglobin > 8 g/dL , and no use of intravenous inotropes or vasopressors .
-RESULTS	Baseline characteristics and treatments of RELAX-AHF-type and non-RELAX-AHF-type patients were compared .
-RESULTS	A Cox model was used to evaluate inpatient mortality .
-RESULTS	Among both Acute Decompensated Heart Failure National Registry-United States and Acute Decompensated Heart Failure National Registry-International registries , 20.7 % ( n = 38 485 ) and 16.2 % ( n = 1749 ) of patients met basic criteria for RELAX-AHF entry , respectively .
-RESULTS	These patients were more likely to be older , be women , have a previous history of hypertension , have preserved ejection fraction , and have better renal function .
-RESULTS	In-hospital mortality was lower in RELAX-AHF-type than in non-RELAX-AHF-type patients , even after multivariable adjustment ( hazard ratio , 0.59 ; 95 % confidence interval , 0.53-0 .66 ; P < 0.0001 ) .
-CONCLUSIONS	Patients potentially eligible for RELAX-AHF represent 2 in 10 patients with AHF in the United States , Latin America , or Asia-Pacific .
-CONCLUSIONS	These patients differ significantly from other hospitalized patients based on clinical characteristics and outcomes .
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-###25454950
-BACKGROUND	When learning multiple tasks , blocked or random training schedules may be used .
-BACKGROUND	We assessed the effects of blocked and random schedules on the acquisition and retention of laparoscopic skills .
-METHODS	Thirty-six laparoscopic novices were randomized to practice laparoscopic tasks using blocked , random , or no additional training .
-METHODS	Participants performed immediate post-tests , followed by retention tests 6 weeks later .
-METHODS	Outcomes included previously validated Fundamentals of Laparoscopic Surgery ( FLS ) and hand-motion efficiency scores .
-RESULTS	Both blocked and random groups had significantly higher FLS and hand-motion efficiency scores over baseline on post-tests for each task ( P < .05 ) and higher overall FLS scores than controls on retention tests ( P < .01 ) .
-RESULTS	No difference was seen between the blocked and random groups in the amount of skill acquired or skill retained .
-CONCLUSIONS	Both blocked and random training schedules can be considered as valid training options to allow programs and learners to tailor training to their individual needs .
-
-###24648266
-BACKGROUND	We investigated the effects of demographic , lifestyle ( self-reported smoking status and physical activity levels ) , cancer-related treatment factors ( radiation and chemotherapy ) , and diet ( calcium and vitamin D intake ) on bone turnover and the relationship of bone turnover to lumbar spine bone mineral density ( BMD ) Z-scores ( LS-BMD Z-scores ) determined by quantitative computed tomography ( QCT ) in 418 5-year survivors of childhood acute lymphoblastic leukemia ( ALL ) .
-METHODS	Bone turnover was assessed by biomarkers including serum bone-specific alkaline phosphatase ( BALP ) , osteocalcin ( OC ) , and urinary N-telopeptide of type I collagen indexed to creatinine ( NTX/Cr ) .
-METHODS	The 215 males ranged in age from 9 to 36 years ( median age 17 years ) .
-RESULTS	Age and tanner score were inversely associated with all biomarkers ( BALP , OC , NTX/Cr ) ( P < 0.001 ) .
-RESULTS	Males had higher BALP and OC than females ( P < 0.001 ) .
-RESULTS	Body mass index ( BMI ) was inversely associated with OC and NTX/Cr ( P < 0.001 ) .
-RESULTS	There was no significant association of biomarkers with lifestyle related factors , ALL treatment-related factors , dietary calcium , vitamin D , or LS-BMD Z-score .
-CONCLUSIONS	In this population of long-term survivors of ALL , bone turnover was significantly associated with age , gender , tanner stage , and BMI .
-CONCLUSIONS	ALL-related treatments did not influence bone turnover and bone turnover was not predictive of volumetric LS-BMD Z-score .
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-###24652494
-BACKGROUND	The vaccine efficacy ( VE ) of 1 or 2 doses of AS03-adjuvanted influenza A ( H1N1 ) vaccine relative to that of 2 doses of nonadjuvanted influenza A ( H1N1 ) vaccine in children 6 months to < 10 years of age in a multinational study conducted during 2010-2011 .
-METHODS	A total of 6145 children were randomly assigned at a ratio of 1:1:1 to receive 2 injections 21 days apart of A/California/7 / 2009 ( H1N1 ) - AS03 vaccine at dose 1 and saline placebo at dose 2 , 2 doses 21 days apart of A/California/7 / 2009 ( H1N1 ) - AS03 vaccine ( the Ad2 group ) , or 2 doses 21 days apart of nonadjuvanted A/California/7 / 2009 ( H1N1 ) vaccine ( the NAd2 group ) .
-METHODS	Active surveillance for influenza-like illnesses continued from days 14 to 385 .
-METHODS	Nose and throat samples obtained during influenza-like illnesses were tested for A/California/7 / 2009 ( H1N1 ) , using reverse-transcriptase polymerase chain reaction .
-METHODS	Immunogenicity , reactogenicity , and safety were assessed .
-RESULTS	There were 23 cases of confirmed 2009 pandemic influenza A ( H1N1 ) ( A [ H1N1 ] pdm09 ) infection for the primary relative VE analysis .
-RESULTS	The VE in the Ad2 group relative to that in the NAd2 group was 76.8 % ( 95 % confidence interval , 18.5 % -93.4 % ) .
-RESULTS	The benefit of the AS03 adjuvant was demonstrated in terms of the greater immunogenicity observed in the Ad2 group , compared with the NAd2 group .
-CONCLUSIONS	The 4-8-fold antigen-sparing adjuvanted pandemic influenza vaccine demonstrated superior and clinically important prevention of A ( H1N1 ) pdm09 infection , compared with nonadjuvanted vaccine , with no observed increase in medically attended or serious adverse events .
-CONCLUSIONS	These data support the use of adjuvanted influenza vaccines during influenza pandemics .
-CONCLUSIONS	Clinical Trials Registration .
-CONCLUSIONS	NCT01051661 .
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-###24989855
-OBJECTIVE	To evaluate the efficacy and safety of intravitreal bevacizumab ( IVB ) in eyes with neovascular glaucoma ( NVG ) undergoing Ahmed glaucoma valve ( AGV ) implantation .
-METHODS	This was a multicentre , prospective , randomized clinical trial that enrolled 40 patients with uncontrolled neovascular glaucoma that had undergone panretinal photocoagulation and required glaucoma drainage device implantation .
-METHODS	Patients were randomized to receive IVB ( 1.25 mg ) or not during Ahmed valve implant surgery .
-METHODS	Injections were administered intra-operatively , and 4 and 8 weeks after surgery .
-RESULTS	After a mean follow-up of 2.25 0.67 years ( range 1.5-3 years ) , both groups showed a significant decrease in IOP ( p < 0.05 ) .
-RESULTS	There was no difference in IOP between groups except at the 18-month interval , when IOP in IVB group was significantly lower ( 14.57 1.72 mmHg vs. 18.37 1.06 mmHg - p = 0.0002 ) .
-RESULTS	There was no difference in survival success rates between groups .
-RESULTS	At 24 months , there was a trend to patients treated with IVB using less antiglaucoma medications than the control group ( p = 0.0648 ) .
-RESULTS	Complete regression of rubeosis iridis was significantly more frequent in the IVB group ( 80 % ) than in the control group ( 25 % ) ( p = 0.0015 ) .
-CONCLUSIONS	Intravitreal bevacizumab may lead to regression of new vessels both in the iris and in the anterior chamber angle in patients with neovascular glaucoma undergoing Ahmed glaucoma valve implantation .
-CONCLUSIONS	There is a trend to slightly lower IOPs and number of medications with IVB use during AGV implantation for neovascular glaucoma .
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-###25407966
-BACKGROUND	EBV-encoded latent membrane protein 1 ( EBV-LMP1 ) is an important oncogenic protein for nasopharyngeal carcinoma ( NPC ) and has been shown to engage a plethora of signaling pathways .
-BACKGROUND	Correspondingly , an LMP1-targeted DNAzyme was found to inhibit the growth of NPC cells both in vivo and in vitro by suppressing cell proliferation and inducing apoptosis .
-BACKGROUND	However , it remains unknown whether an LMP1-targeted DNAzyme would affect the vasculature of NPC .
-BACKGROUND	Dynamic contrast-enhanced magnetic resonance imaging ( DCE-MRI ) has been applied in the clinical trials of anti-angiogenic drugs for more than ten years , and Ktrans has been recommended as a primary endpoint .
-BACKGROUND	Therefore , the objective of the current study was to use DCE-MRI to longitudinally study the effect of an EBV-LMP1-targeted DNAzyme on the vasculature of patients with NPC .
-METHODS	Twenty-four patients were randomly divided into two groups : a combined treatment group ( radiotherapy + LMP1-targeted DNAzyme ) and a radiotherapy alone group ( radiotherapy + normal saline ) .
-METHODS	DCE-MRI scans were conducted 1 ~ 2 days before radiotherapy ( Pre-RT ) , during radiotherapy ( RT 50 Gy ) , upon completion of radiotherapy ( RT 70 Gy ) , and three months after radiotherapy ( 3 months post-RT ) .
-METHODS	Parameters of vascular permeability and intra - and extravascular volumes were subsequently obtained ( e.g. , Ktrans , kep , ve ) using nordicICE software .
-RESULTS	Both Ktrans and kep values for NPC tumor tissues decreased for both groups after treatment .
-RESULTS	Moreover , a statistically significant difference in Ktrans values at the pre-therapy and post-therapy timepoints emerged earlier for the combined treatment group ( RT 50 Gy , P = 0.045 ) compared to the radiotherapy alone group ( 3 months post-RT , P = 0.032 ) .
-RESULTS	For the kep values , the downward trend observed for both the combined treatment group and the radiotherapy alone group were similar .
-RESULTS	In contrast , ve values for all of the tumor tissues increased following therapy .
-CONCLUSIONS	The EBV-LMP1-targeted DNAzyme that was tested was found to accelerate the decline of Ktrans values for patients with NPC .
-CONCLUSIONS	Correspondingly , the LMP1-targeted DNAzyme treatments were found to affect the angiogenesis and microvascular permeability of NPC .
-BACKGROUND	ClinicalTrials.gov : NCT01449942 .
-BACKGROUND	Registered 6 October 2011 .
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-###25082808
-OBJECTIVE	We aimed at comparing the long-term benefit-risk balance of carotid stenting versus endarterectomy for symptomatic carotid stenosis .
-METHODS	Long-term follow-up study of patients included in Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis ( EVA-3S ) , a randomized , controlled trial of carotid stenting versus endarterectomy in 527 patients with recently symptomatic severe carotid stenosis , conducted in 30 centers in France .
-METHODS	The main end point was a composite of any ipsilateral stroke after randomization or any procedural stroke or death .
-RESULTS	During a median follow-up of 7.1 years ( interquartile range , 5.1-8 .8 years ; maximum 12.4 years ) , the primary end point occurred in 30 patients in the stenting group compared with 18 patients in the endarterectomy group .
-RESULTS	Cumulative probabilities of this outcome were 11.0 % ( 95 % confidence interval , 7.9-15 .2 ) versus 6.3 % ( 4.0-9 .8 ) in the endarterectomy group at the 5-year follow-up ( hazard ratio , 1.85 ; 1.00-3 .40 ; P = 0.04 ) and 11.5 % ( 8.2-15 .9 ) versus 7.6 % ( 4.9-11 .8 ; hazard ratio , 1.70 ; 0.95-3 .06 ; P = 0.07 ) at the 10-year follow-up .
-RESULTS	No difference was observed between treatment groups in the rates of ipsilateral stroke beyond the procedural period , severe carotid restenosis ( 70 % ) or occlusion , death , myocardial infarction , and revascularization procedures .
-CONCLUSIONS	The long-term benefit-risk balance of carotid stenting versus endarterectomy for symptomatic carotid stenosis favored endarterectomy , a difference driven by a lower risk of procedural stroke after endarterectomy .
-CONCLUSIONS	Both techniques were associated with low and similar long-term risks of recurrent ipsilateral stroke beyond the procedural period .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00190398 .
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-###25068344
-BACKGROUND	This work evaluates the effect of adding platelet-derived growth factor to autologous adipose tissue grafts in the treatment of human immunodeficiency virus facial lipoatrophy by means of objective measurements .
-METHODS	This is a randomized clinical trial conducted at the Hospital Clinic of Barcelona .
-METHODS	Patients with facial human immunodeficiency virus atrophy were randomized into two groups , one treated with autologous fat injection ( group A ) , and another treated with autologous fat injection with plasma rich in growth factors ( group B ) .
-METHODS	Before the treatment , structural changes were identified in facial soft tissue by means of computed tomography , and clinical changes were also assessed by means of photographic records .
-METHODS	Posttreatment assessments were repeated after 2 and 12 months to compare the results .
-METHODS	Posttreatment complications were recorded .
-RESULTS	Forty-nine patients ( 33 men and 16 women ) , with a mean age of 46 years , participated in the study .
-RESULTS	In both groups , there was a statistically significant average increase of volume in the facial area measured by computed tomography between the baseline and the 2 - and 12-month posttreatment assessments .
-RESULTS	All cases showed an improvement of the clinical facial atrophy grade after treatment , which was statistically significant .
-RESULTS	This improvement was related to a statistically significant fat volume increase measured by means of computed tomography .
-RESULTS	There was no difference in the volume gain between both groups .
-RESULTS	No major complications were observed .
-CONCLUSIONS	Fat grafting is a safe , effective , and durable treatment for human immunodeficiency virus facial atrophy .
-CONCLUSIONS	The results of this study show that it is not necessary to add plasma rich in growth factors to the adipose tissue graft to get a better result .
-METHODS	Therapeutic , II .
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-###25548839
-BACKGROUND	Longevity of effects and dose equivalence of different botulinum toxin type A ( BoNT-A ) preparations need to be better clarified because BoNT-A units are manufacturer-specific .
-BACKGROUND	These points are of particular importance for new brands emerging in the market .
-OBJECTIVE	To assess the field of muscular and anhidrotic effects of 2 commercial preparations of BoNT-A ( incobotulinumtoxinA : Xeomin [ XEO ] ; abobotulinumtoxinA : Dysport [ DYS ] ) administered to the upper third of the face .
-METHODS	Patients were randomized for the side of the forehead ( left or right ) in which the products were administered .
-METHODS	All were treated receiving BoNT-A injections in 10 points ( 5 on each side ) at a dose equivalence of 1.0:2.5 U ( XEO : DYS ) .
-METHODS	Clinical assessments and Minor test were performed at baseline and Days 28 , 84 , 112 , and 140 .
-METHODS	Electromyography was performed at baseline and Days 28 and 140 , and ultrasound was performed only at baseline .
-RESULTS	Eighty patients were enrolled in 2 research centers .
-RESULTS	Xeomin and DYS presented similar results regarding fields of muscular effects .
-RESULTS	However , a larger field of anhidrotic effects was found for DYS .
-RESULTS	There was a positive correlation between the muscle thickness and electromyography results .
-CONCLUSIONS	The results of this study suggest that a lower dose equivalence between DYS and XEO could be established .
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-###25152476
-OBJECTIVE	In the Surgical Treatment for Ischemic Heart Failure trial , surgical ventricular reconstruction plus coronary artery bypass surgery was not associated with a reduction in the rate of death or cardiac hospitalization compared with bypass alone .
-OBJECTIVE	We hypothesized that the absence of viable myocardium identifies patients with coronary artery disease and left ventricular dysfunction who have a greater benefit with coronary artery bypass graft surgery and surgical ventricular reconstruction compared with bypass alone .
-METHODS	Myocardial viability was assessed by single photon computed tomography in 267 of the 1000 patients randomized to bypass or bypass plus surgical ventricular reconstruction in the Surgical Treatment for Ischemic Heart Failure .
-METHODS	Myocardial viability was assessed on a per patient basis and regionally according to prespecified criteria .
-RESULTS	At 3 years , there was no difference in mortality or the combined outcome of death or cardiac hospitalization between those with and without viability , and there was no significant interaction between the type of surgery and the global viability status with respect to mortality or death plus cardiac hospitalization .
-RESULTS	Furthermore , there was no difference in mortality or death plus cardiac hospitalization between those with and without anterior wall or apical scar , and no significant interaction between the presence of scar in these regions and the type of surgery with respect to mortality .
-CONCLUSIONS	In patients with coronary artery disease and severe regional left ventricular dysfunction , assessment of myocardial viability does not identify patients who will derive a mortality benefit from adding surgical ventricular reconstruction to coronary artery bypass graft surgery .
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-###25121980
-BACKGROUND	To prevent salivary dysfunction in thyroid cancer patients who have undergone radioiodine ablation , massaging the parotid gland ( PG ) is presumed to be helpful for the removal of radioiodine .
-BACKGROUND	The purpose of this study was to evaluate the effect of PG massage in the removal of radioiodine from the PG .
-METHODS	Forty-four patients ( female , 38 ; 49.1 11.0 years ) who underwent total thyroidectomy followed by I-131 ablation were included in this prospective study .
-METHODS	Three serial salivary gland scans were performed 2h after administration of I-123 in thyroid hormone withdrawal status .
-METHODS	The patients were divided into two groups .
-METHODS	There was a 1-min ( or 2-min ) interval between the first and second scans for control , followed by the performance of PG massage for 1 min ( or 2 min ) between the second and third scans .
-METHODS	Changes in uptakes were calculated between the first and second scans ( control ) and between the second and third scans ( massage ) .
-RESULTS	The mean change in uptake at the 1-min massage was 0.97 11.27 % , whereas that at the 1-min control was 11.54 5.59 % ( P < 0.001 ) .
-RESULTS	The mean change in uptake at the 2-min massage was also significantly lower than that at the 2-min control ( 11.11 6.97 vs. -0.85 9.78 % , P < 0.001 ) .
-RESULTS	However , no statistical difference was observed between the mean changes in uptake after 1 - and 2-min massages ( P = 0.573 ) .
-CONCLUSIONS	PG massage reduced the radioiodine uptake in the PG , and the effect of PG massage for 1 min was comparable with that of PG massage for 2 min .
-CONCLUSIONS	PG massage can be applied to thyroid cancer patients who receive radioiodine therapy to reduce PG dysfunction .
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-###24781374
-OBJECTIVE	Executive dysfunction after traumatic brain injury ( TBI ) in children is common and leads to significant short - and long-term problems in functioning across multiple settings .
-OBJECTIVE	We hypothesized that improvements in short-term executive function would be maintained to 24 months after injury and that improvements would increase over time in a counselor-assisted problem-solving ( CAPS ) intervention .
-OBJECTIVE	To evaluate the efficacy of a CAPS intervention administered within 7 months of complicated mild to severe TBI compared with an Internet resource condition in improving long-term executive dysfunction .
-METHODS	Multisite , assessor-blinded , randomized clinical trial at 3 tertiary pediatric hospitals and 2 tertiary general medical centers .
-METHODS	Participants included 132 adolescents aged 12 to 17 years who sustained a moderate to severe TBI 1 to 7 months before study enrollment .
-METHODS	Web-based CAPS intervention .
-METHODS	The primary outcome was the parent-reported Global Executive Composite ( GEC ) of the Behavior Rating Inventory of Executive Function .
-METHODS	Secondary outcomes included the Behavioral Regulation Index ( BRI ) and Metacognition Index ( MI ) of the GEC .
-RESULTS	In older ( > 14 to 17 years ) adolescents , the CAPS intervention was associated with lower GEC ratings at 12 ( = -0.46 ; P = .03 ) and 18 ( = -0.52 ; P = .02 ) months after enrollment .
-RESULTS	Trends were also observed for older adolescents toward lower GEC ratings at 6 months ( = -0.40 ; P = .05 ) , lower BRI ratings at 12 ( = -0.40 ; P = .06 ) and 18 ( = -0.47 ; P = .04 ) months , and lower MI ratings at 6 ( = -0.41 ; P = .05 ) , 12 ( = -0.46 ; P = .03 ) , and 18 ( = -0.50 ; P = .03 ) months .
-RESULTS	In younger ( 12-14 years ) adolescents , no group differences were found on the GEC , BRI , or MI ratings .
-CONCLUSIONS	Delivery of the CAPS intervention early after TBI in older adolescents improves long-term executive function .
-CONCLUSIONS	This trial is , to our knowledge , one of the few large , randomized clinical treatment trials performed in pediatric TBI to demonstrate the efficacy of an intervention for management of executive dysfunction and long-term benefits of an intervention delivered soon after injury .
-CONCLUSIONS	Use of the CAPS intervention clinically should be considered ; however , further research should explore ways to optimize delivery .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00409448 .
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-###24923573
-BACKGROUND	Pain control has been emphasized as a priority for both practitioners and inpatients with rib fractures , since analgesia could only offer limited relief from severe pain .
-BACKGROUND	A prospective and randomized controlled trial was conducted to analyze the efficacy and efficiency of acupuncture in acute pain relief for inpatients with rib fractures .
-METHODS	A total of 58 inpatients were recruited and allocated to two groups , receiving identical doses of conventional oral analgesics as well as filiform needles as treatment and thumbtack intradermal ( TI ) needles placed upon the skin surface as a control , respectively , via novel acupuncture modality once daily for three consecutive days .
-METHODS	The effect of pain relief was evaluated during activities that induce pain , and sustained maximal inspiration ( SMI ) lung volumes and sleep quality were assessed .
-RESULTS	The patients treated with filiform needles had more effective pain relief than those in the TI needle group during deep breathing , coughing , and turning over the body ( p < 0.05 ) , and the effect persisted for at least 6 h in most patients .
-RESULTS	Sustained maximal inspiration lung volumes and sleep quality did not show improvement through every acupuncture intervention , and they could not respond accurately to pain relief via acupuncture .
-CONCLUSIONS	The active evaluation could provide a more adaptive model for assessing pain intensity due to rib fractures .
-CONCLUSIONS	This novel acupuncture modality in which the needle insertion sites are corresponding to the pain spots can be a safe and viable therapy for relieving pain in inpatients with rib fractures .
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-###24968966
-BACKGROUND	Impaired glucose tolerance ( IGT ) is a pre-diabetic state of hyperglycemia that is associated with insulin resistance , increased risk of type II diabetes , and cardiovascular pathology .
-BACKGROUND	Recently , investigators hypothesized that decreased vagus nerve activity may be the underlying mechanism of metabolic syndrome including obesity , elevated glucose levels , and high blood pressure .
-METHODS	In this pilot randomized clinical trial , we compared the efficacy of transcutaneous auricular vagus nerve stimulation ( taVNS ) and sham taVNS on patients with IGT .
-METHODS	72 participants with IGT were single-blinded and were randomly allocated by computer-generated envelope to either taVNS or sham taVNS treatment groups .
-METHODS	In addition , 30 IGT adults were recruited as a control population and not assigned treatment so as to monitor the natural fluctuation of glucose tolerance in IGT patients .
-METHODS	All treatments were self-administered by the patients at home after training at the hospital .
-METHODS	Patients were instructed to fill in a patient diary booklet each day to describe any side effects after each treatment .
-METHODS	The treatment period was 12weeks in duration .
-METHODS	Baseline comparison between treatment and control group showed no difference in weight , BMI , or measures of systolic blood pressure , diastolic blood pressure , fasting plasma glucose ( FPG ) , 2-hour plasma glucose ( 2hPG ) , or glycosylated hemoglobin ( HbAlc ) .
-RESULTS	100 participants completed the study and were included in data analysis .
-RESULTS	Two female patients ( one in the taVNS group , one in the sham taVNS group ) dropped out of the study due to stimulation-evoked dizziness .
-RESULTS	The symptoms were relieved after stopping treatment .
-RESULTS	Compared with sham taVNS , taVNS significantly reduced the two-hour glucose tolerance ( F ( 2 ) = 5.79 , p = 0.004 ) .
-RESULTS	In addition , we found that taVNS significantly decreased ( F ( 1 ) = 4.21 , p = 0.044 ) systolic blood pressure over time compared with sham taVNS .
-RESULTS	Compared with the no-treatment control group , patients receiving taVNS significantly differed in measures of FPG ( F ( 2 ) = 10.62 , p < 0.001 ) , 2hPG F ( 2 ) = 25.18 , p < 0.001 ) and HbAlc ( F ( 1 ) = 12.79 , p = 0.001 ) over the course of the 12week treatment period .
-CONCLUSIONS	Our study suggests that taVNS is a promising , simple , and cost-effective treatment for IGT / pre-diabetes with only slight risk of mild side-effects .
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-###25318563
-BACKGROUND	South Africa has 6.4 million adults over the age of 15 living with HIV .
-BACKGROUND	Gender inequality issues continue to drive the HIV epidemic in South Africa , where Black African women bear the greatest HIV burden .
-BACKGROUND	Limited access to services ; little capacity to negotiate sex and condom use ; and other legal , social , and economic inequities make women highly vulnerable to HIV infection .
-BACKGROUND	Behavioral interventions have been shown to decrease risk behaviors , but they have been less successful in reducing HIV incidence .
-BACKGROUND	Conversely , biomedical prevention strategies have proven to be successful in reducing HIV incidence , but require behavioral interventions to increase uptake and adherence .
-BACKGROUND	Consequently , there is a need for integrated approaches that combine biomedical and behavioral interventions .
-BACKGROUND	Effective combination prevention efforts should comprise biomedical , behavioral , and structural programming proven in randomized trials that focuses on the driving forces and key populations at higher risk of HIV infection and transmission .
-METHODS	This prospective , geographically clustered randomized field experiment is enrolling participants into two arms : a control arm that receives standard HIV testing and referral for treatment ; and an intervention arm that receives an evidence-based , woman-focused behavioral intervention that emphasizes risk reduction and retention , the Women 's Health CoOp .
-METHODS	We divided the city of Pretoria into 14 mutually exclusive geographic zones and randomized these zones into either the control arm or the intervention arm .
-METHODS	Outreach workers are recruiting drug-using women from each zone .
-METHODS	At baseline , eligible participants complete a questionnaire and biological testing for HIV , recent drug use , and pregnancy .
-METHODS	Follow-up interviews are completed at 6 and 12months .
-CONCLUSIONS	The biobehavioral intervention in this study merges an efficacious behavioral HIV prevention intervention for women with biomedical prevention through HIV treatment as prevention using a Seek , Test , Treat and Retain strategy .
-CONCLUSIONS	This combination biobehavioral intervention is designed to ( 1 ) improve the quality of life and reduce HIV infectiousness among women who are HIV positive , and ( 2 ) reduce HIV risk behaviors among women regardless of their HIV status .
-CONCLUSIONS	If efficacious , this intervention could help control the HIV epidemic in South Africa .
-BACKGROUND	Trial registration no : NCT01497405 .
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-###24884739
-BACKGROUND	Delirium occurs frequently in older hospitalised patients and is associated with several adverse outcomes .
-BACKGROUND	Ignorance among healthcare professionals and a failure to recognise patients suffering from delirium have been identified as the possible causes of poor care .
-BACKGROUND	The objective of the study was to determine whether e-learning can be an effective means of improving implementation of a quality improvement project in delirium care .
-BACKGROUND	This project aims primarily at improving the early recognition of older patients who are at risk of delirium .
-METHODS	In a stepped wedge cluster randomised trial an e-learning course on delirium was introduced , aimed at nursing staff .
-METHODS	The trial was conducted on general medical and surgical wards from 18 Dutch hospitals .
-METHODS	The primary outcome measure was the delirium risk screening conducted by nursing staff , measured through monthly patient record reviews .
-METHODS	Patient records from patients aged 70 and over admitted onto wards participating in the study were used for data collection .
-METHODS	Data was also collected on the level of delirium knowledge of these wards ' nursing staff .
-RESULTS	Records from 1,862 older patients were included during the control phase and from 1,411 patients during the intervention phase .
-RESULTS	The e-learning course on delirium had a significant positive effect on the risk screening of older patients by nursing staff ( OR 1.8 , p-value < 0.01 ) , as well as on other aspects of delirium care .
-RESULTS	The number of patients diagnosed with delirium was reduced from 11.2 % in the control phase to 8.7 % in the intervention phase ( p = 0.04 ) .
-RESULTS	The e-learning course also showed a significant positive effect on nurses ' knowledge of delirium .
-CONCLUSIONS	Nurses who undertook a delirium e-learning course showed a greater adherence to the quality improvement project in delirium care .
-CONCLUSIONS	This improved the recognition of patients at risk and demonstrated that e-learning can be a valuable instrument for hospitals when implementing improvements in delirium care .
-BACKGROUND	The Netherlands National Trial Register ( NTR ) .
-BACKGROUND	NTR2885 .
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-###26181705
-BACKGROUND	Smoking now represents one of the biggest modifiable risk factors for disease and mortality in people living with HIV ( PLHIV ) .
-BACKGROUND	To produce significant changes in smoking rates among this population , treatments will need to be both acceptable to the larger segment of PLHIV smokers and feasible to implement in busy HIV clinics .
-BACKGROUND	The purpose of this study was to evaluate the feasibility and effects of a novel proactive algorithm-based intervention in an HIV/AIDS clinic .
-METHODS	PLHIV smokers ( N = 100 ) were proactively identified through their electronic medical records and were subsequently randomized at baseline to receive a 12-week pharmacotherapy-based algorithm treatment or treatment as usual .
-METHODS	Participants were tracked in-person for 12 weeks .
-METHODS	Participants provided information on smoking behaviors and associated constructs of cessation at each follow-up session .
-RESULTS	The findings revealed that many smokers reported using prescribed medications when provided with a supply of cessation medication as determined by an algorithm .
-RESULTS	Compared with smokers receiving treatment as usual , PLHIV smokers prescribed these medications reported more quit attempts and greater reduction in smoking .
-RESULTS	Proxy measures of cessation readiness ( eg , motivation , self-efficacy ) also favored participants receiving algorithm treatment .
-CONCLUSIONS	This algorithm-derived treatment produced positive changes across a number of important clinical markers associated with smoking cessation .
-CONCLUSIONS	Given these promising findings coupled with the brief nature of this treatment , the overall pattern of results suggests strong potential for dissemination into clinical settings and significant promise for further advancing clinical health outcomes in this population .
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-###25461357
-OBJECTIVE	To assess efficacy and safety of post-operative intra-peritoneal wash with lactated Ringer 's for 48h after myomectomy in reduction of adhesions compared to routine intra-operative irrigation .
-OBJECTIVE	Study design A prospective , randomized trial that included 52 eligible participants who had undergone abdominal myomectomy .
-OBJECTIVE	Participants were randomly allocated to a treatment group ( n = 26 ) which was subjected to continuous peritoneal wash for 48h via two intraperitoneal drains , and a control group ( n = 26 ) .
-OBJECTIVE	The incidence of de novo adhesions and their severity and extent were scored at a second-look laparoscopy 8-10 weeks postoperatively .
-OBJECTIVE	Adhesions were graded using the local adhesion barrier scoring system score .
-OBJECTIVE	Adverse effects were also assessed and reported .
-RESULTS	There was no statistically significant difference in duration of hospital stay or in the incidence of adverse events .
-RESULTS	A significantly higher proportion of adhesion-free patients was found in the treatment group [ 11/23 , 47.8 % ] compared to the control group [ 4/21 , 19 % ] ( P < 0.01 ) .
-RESULTS	The mean number of pelvic sites covered by adhesions was significantly lower in the treatment group than in the control group ( 2.20.3 versus 4.60.8 , P < 0.05 ) .
-RESULTS	The total adhesion score was significantly lower in the treatment group than in the control group ( 2.10.5 versus 4.81.4 , P < 0.05 ) and the adhesion score was significantly lower at most of the individual anatomical sites .
-CONCLUSIONS	Application of postoperative intraperitoneal wash with lactated Ringer 's solution for 48h may have reasonable safety and efficacy in minimizing postoperative pelvic de novo adhesions following abdominal myomectomy .
-
-###24823696
-BACKGROUND	In the AXIS trial , axitinib prolonged progression-free survival ( PFS ) vs sorafenib in patients with advanced renal cell carcinoma ( RCC ) previously treated with sunitinib or cytokines .
-METHODS	In post hoc analyses , patients were grouped by objective response to prior therapy ( yes vs no ) , prior therapy duration ( < vs median ) , and tumour burden ( baseline sum of the longest diameter < vs median ) .
-METHODS	PFS and overall survival ( OS ) , and safety by type and duration of prior therapy were evaluated .
-RESULTS	Response to prior therapy did not influence outcome with second-line axitinib or sorafenib .
-RESULTS	PFS was significantly longer in axitinib-treated patients who received longer prior cytokine treatment and sorafenib-treated patients with smaller tumour burden following sunitinib .
-RESULTS	Overall survival with the second-line therapy was longer in patients who received longer duration of prior therapy , although not significant in the sunitinib-to-axitinib sequence subgroup ; OS was also longer in patients with smaller tumour burden , but not significant in the cytokine-to-axitinib sequence subgroup .
-RESULTS	Safety profiles differed modestly by type and duration of prior therapy .
-CONCLUSIONS	AXIS data suggest that longer duration of the first-line therapy generally yields better outcome with the second-line therapy and that lack of response to first-line therapy does not preclude positive clinical outcomes with a second-line vascular endothelial growth factor-targeted agent in patients with advanced RCC .
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-###25204768
-OBJECTIVE	To examine baseline predictors of moderate-to-vigorous intensity physical activity ( MVPA ) at the 12-week follow-up in a sample of adults with arthritis participating in a self-directed , multicomponent exercise program .
-METHODS	Pretest-posttest .
-METHODS	Analyses were limited to those randomized to the exercise intervention .
-METHODS	Participants ( n = 152 ) completed a survey assessing demographic , health-related , and arthritis-related factors , and completed anthropometric and functional measurements at baseline .
-METHODS	Self-reported MVPA was assessed at baseline and 12 weeks .
-METHODS	Participants were classified as engaging in 2.5 or < 2.5 h/week of MVPA at the 12-week follow-up .
-METHODS	Baseline demographic , health-related , arthritis-related , and functional factors were examined as predictors of engaging in 2.5 h of MVPA .
-RESULTS	At the 12-week follow-up , 66.5 % ( n = 101 ) of participants engaged in 2.5 h/week of MVPA .
-RESULTS	Those with a higher body mass index , more days with poor physical health , a greater number of health conditions , self-reported hypertension , self-reported high cholesterol , and greater pain and stiffness were less likely to engage in 2.5 h of MVPA at the 12-week follow-up ; those with greater arthritis self-efficacy and better performance on the 6 minute walk test were more likely .
-RESULTS	None of the other factors examined were associated with MVPA .
-CONCLUSIONS	This study uncovered health-related , arthritis-related , and functional factors associated with MVPA that may help guide intervention strategies .
-CONCLUSIONS	Participants with less severe symptoms , better functional performance and fewer comorbidities at baseline were more likely to achieve the recommended MVPA level at 12 weeks ; therefore self-directed PA interventions may be best suited for those with relatively good health status despite arthritis , while those with worse symptoms and health status may benefit more from other intervention delivery modalities such as structured , individualized programs where additional support for managing arthritis symptoms and comorbidity can be addressed .
-
-###26072289
-BACKGROUND	The relative effects of radiation dose escalation ( RDE ) and androgen suppression ( AS ) duration on local prostatic progression ( LP ) remain unclear .
-METHODS	We addressed this in the TROG 03.04 RADAR trial by incorporating a RDE programme by stratification at randomisation .
-METHODS	Men were allocated 6 or 18 months AS18 months zoledronate ( Z ) .
-METHODS	The main endpoint was a composite of clinically diagnosed LP or PSA progression with a PSA doubling time 6 months .
-METHODS	Fine and Gray competing risk modelling with adjustment for site clustering produced cumulative incidence estimates at 6.5 years for each RDE group .
-RESULTS	Composite LP declined coherently in the 66 , 70 and 74 Gy external beam dosing groups and was lowest in the high dose rate brachytherapy boost ( HDRB ) group .
-RESULTS	At 6.5 years , adjusted cumulative incidences were 22 % , 15 % , 13 % and 7 % respectively .
-RESULTS	Compared to 6 months AS , 18 months AS also significantly reduced LP ( p < 0.001 ) .
-RESULTS	Post-radiation urethral strictures were documented in 45 subjects and increased incrementally in the dosing groups .
-RESULTS	Crude incidences were 0.8 % , 0.9 % , 3.8 % and 12.7 % respectively .
-CONCLUSIONS	RDE and increasing AS independently reduce LP and increase urethral strictures .
-CONCLUSIONS	The risks and benefits to the individual must be balanced when selecting radiation dose and AS duration .
-
-###24249695
-METHODS	A randomised , parallel group , pragmatic trial .
-METHODS	A large UK maternity hospital .
-METHODS	Term infants < 2 weeks old with a mild or moderate degree of tongue-tie , and their mothers who were having difficulties breastfeeding .
-OBJECTIVE	To determine if immediate frenotomy was better than standard breastfeeding support .
-METHODS	Participants were randomised to an early frenotomy intervention group or a ` standard care ' comparison group .
-RESULTS	Primary outcome was breastfeeding at 5 days , with secondary outcomes of breastfeeding self-efficacy and pain on feeding .
-RESULTS	Final assessment was at 8 weeks ; 20 also had qualitative interviews .
-RESULTS	Researchers assessing outcomes , but not participants , were blinded to group assignment .
-RESULTS	107 infants were randomised , 55 to the intervention group and 52 to the comparison group .
-RESULTS	Five-day outcome measures were available for 53 ( 96 % ) of the intervention group and 52 ( 100 % ) of the comparison group , and intention-to-treat analysis showed no difference in the primary outcome-Latch , Audible swallowing , nipple Type , Comfort , Hold score .
-RESULTS	Frenotomy did improve the tongue-tie and increased maternal breastfeeding self-efficacy .
-RESULTS	At 5 days , there was a 15.5 % increase in bottle feeding in the comparison group compared with a 7.5 % increase in the intervention group .
-RESULTS	After the 5-day clinic , 44 of the comparison group had requested a frenotomy ; by 8 weeks only 6 ( 12 % ) were breastfeeding without a frenotomy .
-RESULTS	At 8 weeks , there were no differences between groups in the breastfeeding measures or in the infant weight .
-RESULTS	No adverse events were observed .
-CONCLUSIONS	Early frenotomy did not result in an objective improvement in breastfeeding but was associated with improved self-efficacy .
-CONCLUSIONS	The majority in the comparison arm opted for the intervention after 5 days .
-
-###25234015
-OBJECTIVE	To investigate the effect of anti-inflammatory therapy on selective laser trabeculoplasty ( SLT ) outcomes .
-METHODS	Randomized , double-masked , placebo-controlled trial .
-METHODS	Patients with primary open-angle or pseudo-exfoliation glaucoma .
-METHODS	Patients undergoing SLT were randomized to receive placebo ( artificial tears ) , prednisolone acetate 1 % , or ketorolac tromethamine 0.5 % eye drops 4 times per day for 5 days commencing immediately after SLT .
-METHODS	Change in intraocular pressure ( IOP ) from baseline to the 1-month post-SLT visit .
-RESULTS	Mean change in IOP at the 1-month primary outcome time point , as well as all other time points , was not significantly different among groups ( P = 0.99 ) .
-RESULTS	Likewise , a repeated-measures , mixed-effects model did not find significant differences in IOP outcome at the 1-month time point ( P = 0.95 ) .
-RESULTS	The IOP was reduced in all groups at the 1-month post-SLT time point and all other time points , and no significant differences were found between groups using separate unadjusted cross-sectional analyses of variance ( P > 0.15 for analyses at all time points ) .
-RESULTS	Treatment failure rates were not different among groups ( P = 0.75 ) , and at 1 year after SLT , the percentage of patients maintaining a 20 % IOP reduction ranged from 18 % to 22 % in the 3 study groups .
-CONCLUSIONS	Anti-inflammatory therapy after SLT does not seem to substantially influence the IOP-lowering effect of SLT .
-CONCLUSIONS	In this study of patients with low baseline IOP , SLT showed limited efficacy in achieving a sustained reduction in IOP .
-
-###24642133
-OBJECTIVE	The aim of the present randomized study was to evaluate the efficacy of intermaxillary fixation screw ( IMFS ) versus eyelet interdental wiring for intermaxillary fixation ( IMF ) in minimally displaced mandibular fractures .
-METHODS	A total of 50 patients with a minimally displaced mandibular fracture were enrolled , with 25 patients randomly selected for each group .
-METHODS	In group I ( study group , n = 25 ) , the patients were treated using IMFS , and in group II ( control group , n = 25 ) , they received eyelet interdental wiring .
-METHODS	Both techniques were assessed for the following parameters : time required for placement and removal of each type of IMF technique , time required for placement of IMF wires , postoperative occlusion , stability of the IMF wire , local anesthesia requirement during removal of each fixation type , oral hygiene status , glove perforation rate , and complications associated with both techniques .
-METHODS	The collected data were analyzed using Student 's unpaired t test or 2 test .
-METHODS	P < .05 was considered significant and the Statistical Package for Social Sciences software , version 10 , was used for analysis .
-RESULTS	The average time required for placement in groups I and II was 17.56 and 35.08 minutes , respectively ( P = .000 ) .
-RESULTS	The time required for placement of the IMF wire in group I was 2.1 minutes and in group II was 6 minutes .
-RESULTS	The oral hygiene status was assessed , and the mean plaque index score for groups I and II was 1.44 and 2.12 , respectively ( P = .00 ) .
-RESULTS	The glove perforation rate was much less in group I than in group II .
-RESULTS	Finally , the most common complication in both groups was mucosal growth .
-CONCLUSIONS	The results established the supremacy of IMFS compared with eyelet interdental wiring .
-CONCLUSIONS	Thus , we have concluded that IMFS , in the present scenario , is a safe and time-saving technique .
-CONCLUSIONS	IMFS is a cost-effective , straightforward , and viable alternative to cumbersome eyelet interdental and other wiring techniques for providing IMF , with satisfactory occlusion during closed reduction or intraoperative open reduction internal fixation of fractures .
-CONCLUSIONS	In addition , oral hygiene can be maintained , and the glove perforation rate was very low using IMFS .
-CONCLUSIONS	The relatively small sample size and limited follow-up period were the study limitations .
-
-###25084009
-OBJECTIVE	This study compares the effects of neutral temperature , cold and ice-slush beverages , with and without 0.5 % menthol on cycling performance , core temperature ( Tco ) and stress responses in a tropical climate ( hot and humid conditions ) .
-METHODS	Twelve trained male cyclists/triathletes completed six 20-km exercise trials against the clock in 30.7 C0 .8 C and 78 % 0.03 % relative humidity .
-METHODS	Before and after warm-up , and before exercise and every 5 km during exercise , athletes drank 190 mL of either aromatized ( i.e. , with 0.5 mL of menthol ( 5 gr/L ) ) or a non-aromatized beverage ( neutral temperature : 23C0 .1 C , cold : 3C0 .1 C , or ice-slush : -1 C0 .7 C ) .
-METHODS	During the trials , heart rate ( HR ) was continuously monitored , whereas core temperature ( Tco ) , thermal comfort ( TC ) , thermal sensation ( TS ) and rate of perceived exertion ( RPE ) were measured before and after warm-up , every 5 km of exercise , and at the end of exercise and after recovery .
-RESULTS	Both the beverage aroma ( P < 0.02 ) and beverage temperature ( P < 0.02 ) had significant and positive effects on performance , which was considerably better with ice-slush than with a neutral temperature beverage , whatever the aroma ( P < 0.002 ) , and with menthol vs non-menthol ( P < 0.02 ) .
-RESULTS	The best performances were obtained with ice-slush/menthol and cold/menthol , as opposed to neutral/menthol .
-RESULTS	No differences were noted in HR and Tco between trials .
-CONCLUSIONS	Cold water or ice-slush with menthol aroma seems to be the most effective beverage for endurance exercise in a tropical climate .
-CONCLUSIONS	Further studies are needed to explore its effects in field competition .
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-###25075834
-BACKGROUND	Artemisinin resistance in Plasmodium falciparum has emerged in Southeast Asia and now poses a threat to the control and elimination of malaria .
-BACKGROUND	Mapping the geographic extent of resistance is essential for planning containment and elimination strategies .
-METHODS	Between May 2011 and April 2013 , we enrolled 1241 adults and children with acute , uncomplicated falciparum malaria in an open-label trial at 15 sites in 10 countries ( 7 in Asia and 3 in Africa ) .
-METHODS	Patients received artesunate , administered orally at a daily dose of either 2 mg per kilogram of body weight per day or 4 mg per kilogram , for 3 days , followed by a standard 3-day course of artemisinin-based combination therapy .
-METHODS	Parasite counts in peripheral-blood samples were measured every 6 hours , and the parasite clearance half-lives were determined .
-RESULTS	The median parasite clearance half-lives ranged from 1.9 hours in the Democratic Republic of Congo to 7.0 hours at the Thailand-Cambodia border .
-RESULTS	Slowly clearing infections ( parasite clearance half-life > 5 hours ) , strongly associated with single point mutations in the `` propeller '' region of the P. falciparum kelch protein gene on chromosome 13 ( kelch13 ) , were detected throughout mainland Southeast Asia from southern Vietnam to central Myanmar .
-RESULTS	The incidence of pretreatment and post-treatment gametocytemia was higher among patients with slow parasite clearance , suggesting greater potential for transmission .
-RESULTS	In western Cambodia , where artemisinin-based combination therapies are failing , the 6-day course of antimalarial therapy was associated with a cure rate of 97.7 % ( 95 % confidence interval , 90.9 to 99.4 ) at 42 days .
-CONCLUSIONS	Artemisinin resistance to P. falciparum , which is now prevalent across mainland Southeast Asia , is associated with mutations in kelch13 .
-CONCLUSIONS	Prolonged courses of artemisinin-based combination therapies are currently efficacious in areas where standard 3-day treatments are failing .
-CONCLUSIONS	( Funded by the U.K. Department of International Development and others ; ClinicalTrials.gov number , NCT01350856 . )
-
-###24996524
-BACKGROUND	Benzodiazepines ( BDZs ) are the gold standard in the treatment of alcohol withdrawal syndrome ( AWS ) .
-BACKGROUND	Sodium oxybate ( SMO ) has been tested as a treatment for AWS with encouraging results .
-BACKGROUND	The aim of this phase IV , multicenter , randomized , double-blind , double-dummy study was to evaluate the efficacy of SMO in comparison with oxazepam in the treatment of uncomplicated AWS .
-METHODS	Alcohol-dependent outpatients ( n = 126 ) affected by uncomplicated AWS according to the Clinical Institute Withdrawal Assessment for Alcohol-revised ( CIWA-Ar ) scale were enrolled in the study and randomized in two groups : 61 patients received SMO and 65 patients received oxazepam for 10 days .
-METHODS	The primary endpoint was the reduction of symptoms of AWS measured by the change in the total CIWA-Ar score from baseline ( day 1 ) to the end of the study ( day 10 ) .
-METHODS	This study is registered with ClinicalTrials.gov , number : NCT02090504 RESULTS : A significant decrease of the mean total CIWA-Ar score from baseline to the end of the study was found in both the SMO ( p < 0.0001 ) and the oxazepam group ( p < 0.0001 ) , with no significant differences between the two treatments ( p = 0.21 ) .
-METHODS	Treatment with SMO and oxazepam resulted in a marked decrease in the severity of the mean CIWA subscales , i.e. sweating , tremor , and anxiety , with no significant differences between the two treatments .
-METHODS	Both drugs were well tolerated and no severe side effects were reported .
-CONCLUSIONS	SMO is as effective as oxazepam , one of the gold standard BDZs , in the treatment of uncomplicated AWS .
-CONCLUSIONS	Due to its tolerability and absence of significant side effects , SMO may be considered a valid alternative choice in the treatment of AWS .
-
-###24289591
-BACKGROUND	Cervical cancer is the second most common cancer among Malaysian women with an ASR of 17.9 and a mortality rate of 5.6 per 100,000 population in 2008 ( GLOBOCAN , 2008 ) .
-BACKGROUND	The 5 year prevalence was estimated to be 14.5 per 100,000 population .
-BACKGROUND	As the second most common cancer affecting productive females , cervical cancer imposes an impact to the socioeconomic aspect of the country .
-BACKGROUND	However , the poor uptake of cervical cancer screening is a major problem in detecting early pre-cancerous lesions and thus , delay in initiating treatment for cervical cancer .
-BACKGROUND	Realizing the urgency to increase the uptake of PAP smear , besides enhancing the promotion of PAP smear screening for women above 35 years old , the call-recall system for pap smear screening had been piloted in one of the suburban districts which aimed to improve regular participation of women for cervical and breast cancer screening .
-BACKGROUND	This is of public health importance as identifying the best feasible option to increase patient 's respond to participate in the screening program effectively in our setting will be helpful in implementing an organized regular population based screening program tailored to our setting .
-BACKGROUND	The pilot program of cervical cancer screening in Klang was an opportunity to assess different options in recalling patients for a repeat pap smear to increase their participation and adherence to the program .
-RESULTS	This was a population based randomized control trial .
-RESULTS	Women aged 20-65 years in the population that matched the inclusion and exclusion criteria were re-called for a repeat smear .
-RESULTS	There are four different intervention groups ; letter , registered letters , short messages services ( SMS ) and phone calls where 250 subjects were recruited into each group .
-RESULTS	Samples were generated randomly from the same population in Klang into four different groups .
-RESULTS	The first group received a recall letter for a repeat smear similar to the one that has been given during the first invitation .
-RESULTS	The intervention groups were either be given a registered letter , an SMS or a phone call to re-call them .
-RESULTS	The socio-demographic data of the patients who came for uptake were collected for further analysis .
-RESULTS	All the groups were followed up after 8 weeks to assess their compliance to the recall .
-CONCLUSIONS	The study will provide recommendations about the most effective methods for recall in a population based pap smear screening program on two outcomes : i ) patients response ; ii ) uptake for repeat pap smear .
-
-###25064164
-OBJECTIVE	To determine the pharmacokinetics ( PK ) and placental transfer of intravenous ( i.v. ) N-acetylcysteine ( NAC ) in mothers with a clinical diagnosis of chorioamnionitis ( CA ) and determine the PK of i.v. NAC in their infants .
-METHODS	In this prospective , double-blind study i.v. NAC 100 mg/kg/dose or saline was administered within 4 hours of CA diagnosis to pregnant women 24 weeks ' gestation and then every 6 hours until delivery .
-METHODS	Maternal PK and placental transfer were determined with maternal blood and matched maternal and cord venous blood .
-METHODS	Neonatal PK estimates were determined from i.v. NAC ( 12.5-25 mg/kg/dose ) administered every 12 hours for 5 doses .
-METHODS	Noncompartmental analyses were performed for maternal and neonatal PK estimates .
-RESULTS	Eleven mothers ( 5 preterm , 6 near-term ) and 12 infants ( 1 set of twins ) received NAC .
-RESULTS	Maternal clearance ( CL ) of NAC was faster than in nonpregnant adults , with a terminal elimination half-life of 1.2 0.2 hours .
-RESULTS	The NAC cord to maternal ratio was 1.4 0.8 , suggesting rapid placental transfer and slower rate of fetal CL .
-RESULTS	Neonatal PK estimates for near-term compared with preterm infants showed a significantly shorter terminal elimination half-life ( 5.1 vs 7.5 hours , respectively ) and greater CL ( 53.7 vs 45.0 mL/h/kg , respectively ) .
-CONCLUSIONS	Maternal CL and placental transfer of NAC was rapid , with umbilical cord concentrations frequently exceeding maternal concentrations .
-CONCLUSIONS	The administration of NAC to mothers with CA achieves predictable NAC plasma concentrations in the fetus , indicating that antenatal neuroprotection may be possible for these newborns at high risk for neuroinflammation .
-
-###25983216
-OBJECTIVE	The primary study hypothesis was that ranibizumab 0.5 mg monotherapy or combined with laser is superior to laser monotherapy based on mean average change in best-corrected visual acuity ( BCVA ) over 12 months in Asian patients with visual impairment resulting from diabetic macular edema ( DME ) .
-METHODS	A 12-month , randomized , double-masked , multicenter , laser-controlled , phase III study .
-METHODS	Three hundred ninety-six patients aged 18 years , with type 1 or 2 diabetes mellitus , BCVA of 78-39 Early Treatment Diabetic Retinopathy Study ( ETDRS ) letters , and visual impairment resulting from DME .
-METHODS	Patients were randomized to ranibizumab + sham laser ( n = 133 ) , ranibizumab + active laser ( n = 132 ) , or sham injection + active laser ( n = 131 ) .
-METHODS	Ranibizumab/sham injections were administered on day 1 and continued monthly .
-METHODS	As of month 3 , monthly injections were continued if stable vision was not reached .
-METHODS	Treatment was reinitiated if BCVA decreased because of DME progression .
-METHODS	Active/sham laser was administered on day 1 and thereafter according to ETDRS guidelines .
-METHODS	Average change in BCVA from baseline to months 1 through 12 , central retinal subfield thickness ( CRST ) , and safety over 12 months .
-RESULTS	Ranibizumab monotherapy or combined with laser was superior to laser in improving mean average change in BCVA from baseline to months 1 through 12 ( +5.9 and +5.7 vs +1.4 letters ) .
-RESULTS	At month 12 , greater proportion of patients gained 15 letters with ranibizumab and ranibizumab + laser compared with laser ( 18.8 % and 17.8 % vs 7.8 % ) .
-RESULTS	Mean CRST reduced significantly from baseline to month 12 with ranibizumab ( -134.6 m ) and ranibizumab + laser ( -171.8 m ) versus laser ( -57.2 m ) .
-RESULTS	Patients received a mean of 7.8 and 7.0 ranibizumab injections in the ranibizumab and ranibizumab + laser arms , respectively , and 1.5-1 .9 active laser across treatment arms over 12 months .
-RESULTS	Conjunctival hemorrhage was the most common ocular , whereas nasopharyngitis and hypertension were the most common nonocular adverse events .
-RESULTS	Ranibizumab was not associated with any cases of cerebrovascular hemorrhage and cerebrovascular ischemia .
-RESULTS	No death related to study treatment was reported .
-CONCLUSIONS	Ranibizumab monotherapy or combined with laser showed superior BCVA improvements over laser treatment alone in Asian patients with visual impairment resulting from DME .
-CONCLUSIONS	No new ocular or nonocular safety findings were observed and treatment was well tolerated over 12 months .
-
-###24871380
-OBJECTIVE	Despite promising results of Er : YAG laser in periodontal debridement , to date there is no consensus about the ideal settings for clinical use .
-OBJECTIVE	This experimental clinical trial aimed to determine the effects of debridement using Er : YAG laser and to compare with ultrasonic treatment .
-METHODS	Sixty-four teeth were divided into two in vivo and in vitro subgroups .
-METHODS	Each tooth received ultrasonic treatment on one side and Er : YAG laser debridement at either 60 , 100 , 160 or 250 mJ pulse ( -1 ) and at 10 Hz on the other side on a random basis .
-METHODS	All samples were morphologically analyzed afterwards under scanning electron microscope for surface changes and dentinal tubules exposure .
-METHODS	Treatment duration ( d ) was also recorded .
-RESULTS	Laser debridement produced an irregular , rough and flaky surface free of carbonization or meltdown while ultrasound produced a relatively smoother surface .
-RESULTS	The number of exposed dentinal tubules ( n ) followed an energy-dependent trend .
-RESULTS	The number of exposed tubules among the in vivo laser groups was n 60 mJ = n 100 mJ < n 160 mJ < n 250 mJ ( P < 0.001 ) .
-RESULTS	Also 160 and 250 mJ lasers led to significantly more dentinal exposure than ultrasound under in vivo condition .
-RESULTS	Within the in vitro laser groups , dentinal tubules exposure was n 60 mJ < n 100 mJ < n 160 mJ < n 250 mJ ( P 0.0015 ) .
-RESULTS	Furthermore , in vitro laser treatments at 100 , 160 and 250 mJ led to significantly more dentinal denudation than ultrasound .
-RESULTS	Treatment duration ( d ) for the in vivo groups was d 60 mJ > d 100 mJ > d Ultrasound = d 160 mJ > d 250 mJ ( P 0.046 ) , while for the in vitro groups it was d 60 mJ > d 100 mJ = d Ultrasound = d 160 mJ > d 250 mJ ( P 0.046 ) .
-CONCLUSIONS	Due to excessive treatment duration and surface damage , Er : YAG laser debridement at 60 and 250 mJ pulse ( -1 ) , respectively , is not appropriate for clinical use .
-CONCLUSIONS	Although laser debridement at 100 and 160 mJ pulse ( -1 ) seems more suitable for clinical application , compared to ultrasound the former is more time-consuming and the latter is more aggressive .
-CONCLUSIONS	Using a feedback device or lower pulse energies are recommended when using laser in closed field .
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-###25981836
-OBJECTIVE	To determine whether dexmedetomidine sedation in the postanesthesia care unit ( PACU ) could decrease agitation and delirium after free flap surgery .
-METHODS	Eighty patients were randomly divided into 2 groups .
-METHODS	In the experimental group , dexmedetomidine was given at an hourly infusion rate of 0.5 g/kg for 1hour before the operation was completed and continued in the PACU at 0.2 to 0.7 g/kg continuously until the next morning .
-METHODS	In the control group , normal saline was given during the same periods .
-METHODS	Patients in the 2 groups received sufentanil and midazolam for sedation and pain relief when necessary .
-METHODS	Agitation was monitored with the Riker Sedation-Agitation Scale in the PACU and delirium was monitored with the Confusion Assessment Method for the Intensive Care Unit for 5days postoperatively .
-RESULTS	The overall incidence of agitation was similar between the 2 groups .
-RESULTS	However , when the influence of patient shifting was excluded , the incidence of agitation in the dexmedetomidine group was apparently lower than that in the control group ( 10.3 vs 30 % ; P = .029 ) .
-RESULTS	No difference was found in the occurrence of delirium between the experimental and control groups ( 5.1 vs 12.5 % ; P = .432 ) .
-CONCLUSIONS	Dexmedetomidine does not change the overall incidence of agitation after free flap surgery ; however , it does decrease agitation after PACU admission .
-CONCLUSIONS	It does not prevent delirium within 5days postoperatively .
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-###25528350
-BACKGROUND	Through many years , the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation .
-BACKGROUND	However , preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level .
-BACKGROUND	No randomised trial has been conducted comparing sedation with no sedation , a priori powered to have all-cause mortality as primary outcome.The objective is to assess the benefits and harms of non-sedation versus sedation with a daily wake-up trial in critically ill patients .
-METHODS	The non-sedation ( NONSEDA ) trial is an investigator-initiated , randomised , clinical , parallel-group , multinational trial designed to include 700 patients from at least six ICUs in Denmark , Norway and Sweden.Inclusion criteria are mechanically ventilated patients with expected duration of mechanical ventilation > 24 hours.Exclusion criteria are non-intubated patients , patients with severe head trauma , coma at admission or status epilepticus , patients treated with therapeutic hypothermia , patients with PaO2/FiO2 < 9 where sedation might be necessary to ensure sufficient oxygenation or place the patient in prone position.Experimental intervention is non-sedation supplemented with pain management during mechanical ventilation.Control intervention is sedation with a daily wake-up trial.The primary outcome will be all cause mortality at 90 days after randomization .
-METHODS	Secondary outcomes will be : days until death throughout the total observation period ; coma - and delirium-free days ; highest RIFLE score ; days until discharge from the intensive care unit ( within 28 days ) ; days until the participant is without mechanical ventilation ( within 28 days ) ; and proportion of patients with a major cardiovascular outcome .
-METHODS	Explorative outcomes will be : all cause mortality at 28 days after randomisation ; days until discharge from the intensive care unit ; days until the participant is without mechanical ventilation ; days until discharge from the hospital ; organ failure.Trial size : we will include 700 participants ( 2350 ) in order to detect or reject 25 % relative risk reduction in mortality with a type I error risk of 5 % and a type II error risk of 20 % ( power at 80 % ) .
-CONCLUSIONS	The trial investigates potential benefits of non-sedation .
-CONCLUSIONS	This might have large impact on the future treatment of mechanically ventilated critically ill patients .
-BACKGROUND	ClinicalTrials.gov NCT0196768 , 09.01.2014 .
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-###24362859
-OBJECTIVE	Few school programs are effective in preventing adolescents ' tobacco smoking initiation .
-OBJECTIVE	The `` Lega contro i Tumori - Luoghi di Prevenzione '' is a cluster randomized controlled trial designed to evaluate a school-based peer-led smoking prevention intervention with extracurricular activities for students aged 14-15 years .
-OBJECTIVE	This paper presents the study design and the baseline characteristics of the study population .
-METHODS	Twenty secondary schools located in the Reggio Emilia province took part in the study .
-METHODS	Five schools were excluded because they already participated in smoking prevention interventions .
-METHODS	The schools were randomized to control or intervention arms .
-METHODS	The study population consisted of students attending the first grade .
-METHODS	Components of the intervention included 1 ) the out-of-school `` Smoking Prevention Tour '' ( SPT ) at the `` Luoghi di Prevenzione '' Center , a 4-hour ( 4 sessions ) extracurricular activity ; 2 ) the `` Smoke-free Schools '' intervention , combining a life-skills-based peer-led intervention at school , an in-depth lesson on one of the SPT sessions , and enforcement surveillance of the school antismoking policy .
-METHODS	Tobacco use was studied through a questionnaire administered before and 6 months after the intervention .
-RESULTS	Eleven high schools and 9 vocational secondary schools took part in the study for a total of 2,476 out of 3,050 eligible students ( 81.2 % ) .
-RESULTS	The proportions of respondents in high schools and vocational secondary schools were 90.9 % and 64.5 % , respectively ( P < 0.001 ) .
-RESULTS	Intervention and control arms showed a different distribution of gender and school type , whereas no difference was observed in any tobacco-use characteristic .
-CONCLUSIONS	This study is one of the few Italian trials to evaluate the effectiveness of a school-based program for preventing smoking initiation .
-
-###24315293
-OBJECTIVE	To study the change in spherical equivalent and other ocular parameters 1 year after stopping the administration of atropine .
-METHODS	Prospective randomized double-masked clinical trial .
-METHODS	We assigned 400 myopic children , 6 to 12 years of age , to receive atropine 0.5 % , 0.1 % or 0.01 % for 24 months , after which medication was stopped .
-METHODS	Parents and children gave informed consent to participate in the research .
-METHODS	Children were reviewed at 26 , 32 and 36 months , and changes in cycloplegic spherical equivalent ( SE ) , axial length ( AL ) , visual acuity , pupil size , and accommodation were assessed .
-RESULTS	Of the children , 356 ( 89 % ) entered into the washout phase .
-RESULTS	At entry , there was no significant difference in age , gender , SE , or AL among the children in the various atropine groups .
-RESULTS	Over the following 12 months , myopic progression was greater in the 0.5 % eyes ( -0.87 0.52 D ) , compared to the 0.1 % ( -0.68 0.45 D ) and 0.01 % eyes ( -0.28 0.33 D , P < 0.001 ) .
-RESULTS	AL growth was also greater in the 0.5 % ( 0.35 0.20 mm ) and 0.1 % ( 0.33 0.18 mm ) eyes , compared to the 0.01 % eyes ( 0.19 0.13 mm , P < 0.001 ) .
-RESULTS	Pupil size and near visual acuity returned to pre-atropine levels in all groups , but accommodation at 36 months was less in the 0.5 % eyes ( 13.24 2.72 D ) compared to the 0.1 % ( 14.45 2.61 D ) and 0.01 % eyes ( 14.04 2.90 D , P < 0.001 ) .
-RESULTS	The overall increase in SE over the entire 36 months in the 0.5 % , 0.1 % and 0.01 % groups was -1.15 0.81 D , -1.04 0.83 D and -0.72 0.72 D , respectively ( P < 0.001 ) .
-CONCLUSIONS	There was a myopic rebound after atropine was stopped , and it was greater in eyes that had received 0.5 % and 0.1 % atropine .
-CONCLUSIONS	The 0.01 % atropine effect , however , was more modulated and sustained .
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-###24331983
-BACKGROUND	The purpose of this prospective , randomized , double-blind , placebo-controlled study was to determine the effect of the administration of the combination acetaminophen/hydrocodone on the anesthetic success of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis .
-METHODS	One hundred emergency patients in moderate to severe pain diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received , in a double-blind manner , identical capsules of either a combination dose of 1000 mg acetaminophen/10 mg hydrocodone or placebo 60 minutes before the administration of a conventional inferior alveolar nerve ( IAN ) block .
-METHODS	Endodontic access was begun 15 minutes after completion of the block , and all patients used for data analysis had profound lip numbness .
-METHODS	Success was defined as no or mild pain ( visual analog scale recordings ) on pulpal access or instrumentation .
-RESULTS	The success rate for the IAN block was 32 % for the combination dose of 1000 mg acetaminophen/10 hydrocodone and 28 % for the placebo dose , with no statistically significant difference between the 2 groups ( P = .662 ) .
-CONCLUSIONS	A combination dose of 1000 mg acetaminophen/10 mg hydrocodone given 60 minutes before the administration of the IAN block did not result in a statistically significant increase in anesthetic success for mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis .
-
-###24947625
-BACKGROUND	The aim of this study is to evaluate the benefits and disadvantages of closing the mesenteric defects during gastric bypass to avoid internal herniation ( IH ) .
-METHODS	The study is performed as a single-centre , randomised , controlled , blinded trial .
-METHODS	Patients are randomly assigned to either conventional laparoscopic Roux-en-Y gastric bypass ( LRYGB ) without closing the mesenteric defects ( n = 250 ) or RYGB with closing of the defects with hernia clips ( n = 250 ) .
-METHODS	Follow-up is conducted at six months , one year , two years and five years after RYGB .
-METHODS	The primary endpoint is the incidence of IH .
-CONCLUSIONS	This study will be the first Danish , randomised , controlled study comparing conventional LRYGB with and without closure of the mesenteric defects .
-CONCLUSIONS	The results will contribute to evidence-based recommendations for the prevention of IH .
-BACKGROUND	not relevant .
-BACKGROUND	The study was registered with the Danish Data Protection Agency ( SN-10-2012 ) and The Central Denmark Regional Committees on Biomedical Research Ethics ( 1-01-83-0209-12 , SJ-284 ) .
-BACKGROUND	The study is registered with clinicaltrials.gov : NCT01595230 .
-
-###25037960
-OBJECTIVE	We performed a multicenter , randomized , double-blind trial to assess the efficacy and safety of a single , fixed , intravenous dose of palonosetron ( 0.075 mg ) in the treatment of established postoperative nausea and vomiting ( PONV ) .
-METHODS	Three hundred and eighty-four patients who had at least one risk factors of PONV and underwent surgery under general anesthesia were screened .
-METHODS	Those who developed PONV were randomized to receive either 0.075 mg intravenous palonosetron or a placebo .
-METHODS	The incidence of nausea and vomiting , severity of nausea , requirements for rescue anti-emetics , and adverse effects at 2 , 24 , and 72 h after drug administration were evaluated .
-METHODS	Complete response ( CR ) and complete control ( CC ) rate were compared for 24 and 72 h.
-RESULTS	Among the 384 patients , 152 ( 39.6 % ) developed PONV and were randomized to either the palonosetron ( n = 75 ) or placebo ( n = 77 ) group .
-RESULTS	The number of patients with CR at 24 and 72 h was higher in the palonosetron group than the placebo group [ 0-24 h : n = 49 ( 68.1 % ) vs. n = 30 ( 40.5 % ) , p < 0.001 ; 0-72 h : n = 47 ( 65.3 % ) vs. n = 28 ( 37.8 % ) , p < 0.001 ] .
-RESULTS	The incidence of PONV at 2 , 24 , and 72 h periods was lower in the palonosetron group than the placebo group ( 29.2 , 45.8 , and 50.0 % in the palonosetron group vs. 50.0 , 62.2 , and 66.2 % in the placebo group , p = 0.010 , 0.048 , 0.047 , respectively ) .
-RESULTS	The incidence of adverse events was not different between the groups .
-CONCLUSIONS	A single 0.075 mg IV dose of palonosetron effectively increased the CR rates at 24 and 72 h in these moderate-risk patients with established PONV .
-
-###24339297
-OBJECTIVE	Assessing the immunogenicity of a single dose of hepatitis A virus ( HAV ) vaccines is important because some people receive only a single dose .
-OBJECTIVE	However , previous studies have shown variable results and have not examined the effects of demographic characteristics other than gender .
-OBJECTIVE	This study was performed to examine the immunogenicity of a single dose of HAV vaccine according to the vaccine type and demographic characteristics in young adults .
-METHODS	Seronegative medical school students were randomly allocated to receive either Havrix or Epaxal .
-RESULTS	After approximately 11 months , the seroconversion rate in 451 participants was 80.7 % .
-RESULTS	In men , the Havrix group showed a significantly higher seroconversion rate ( 81.9 % ) than the Epaxal group ( 69.2 % ) , whereas both vaccine groups showed similarly high immunogenicity in women ( Havrix : 90.1 % , Epaxal : 92.9 % ; P for interaction = 0.062 ) .
-RESULTS	According to the results of a multivariate analysis , Epaxal showed significantly lower immunogenicity than Havrix only in men .
-RESULTS	Age , obesity , drinking , smoking , and follow-up time did not significantly affect seroconversion in either gender .
-CONCLUSIONS	The seroconversion rate of single-dose HAV vaccines was low in men , particularly in those who received Epaxal .
-CONCLUSIONS	Our results suggest that gender effects should be considered when comparing the immunogenicity of different HAV vaccines .
-
-###24315492
-OBJECTIVE	To compare the corticosteroid injection ( CSI ) with or without thumb spica cast ( TSC ) for de Quervain tendinitis .
-METHODS	In this prospective trial , 67 eligible patients with de Quervain tenosynovitis were randomly assigned into CSI + TSC ( 33 cases ) and CSI ( 34 cases ) groups .
-METHODS	All patients received 40 mg of methylprednisolone acetate with 1 cc lidocaine 2 % in the first dorsal compartment at the area of maximal point tenderness .
-METHODS	The primary outcome was the treatment success rate , and the secondary outcome was the scale and quality of the treatment method using Quick Disabilities of Arm , Shoulder and Hand and visual analog scale scores .
-RESULTS	The groups had no differences in mean age , sex , and occupation .
-RESULTS	The visual analog scale and Quick Disabilities of the Arm , Shoulder and Hand scores were similar in both groups before the treatment .
-RESULTS	The treatment success rate was 93 % in the CSI + TSC group and 69 % in the CSI group .
-RESULTS	Although both methods improved the patients ' conditions significantly in terms of relieving pain and functional ability , CSI + TSC had a significantly higher treatment success rate .
-CONCLUSIONS	The combined technique of corticosteroid injection and thumb spica casting was better than injection alone in the treatment of de Quervain tenosynovitis in terms of treatment success and functional outcomes .
-METHODS	Therapeutic II .
-
-###26121801
-BACKGROUND	Preoperative oral rehydration solution ( ORS ) prevents hypovolemia .
-BACKGROUND	The aim of this study was to compare the effect of intubating dose of rocuronium in patients taking and those not taking preoperative ORS .
-METHODS	Twenty patients , ASA I aged 20-50 years scheduled for elective surgery , were investigated and randomly assigned to two groups : drinking 1,500 ml ORS 6 to 2 hours before anesthesia ( ORS group ) and nothing by mouth from 6 hours before anesthesia ( control group ) .
-METHODS	Anesthesia was maintained with propofol and remifentanil , and rocuronium 0.6 mg x kg ( -1 ) was administrated .
-METHODS	To evaluate the effect of rocuronium , acceleromyography at the adductor pollicis was performed using 0.1 Hz stimulation .
-METHODS	Cardiac index ( CI ) and stroke volume variation ( SVV ) from FloTra/Vigileo , times to 95 % twitch depression as onset time ( OT ) , and times to first twitch re-detection ( TR ) were recorded .
-RESULTS	SVV was significantly lower in ORS group ( P = 0.03 ) , and CI showed no difference .
-RESULTS	In ORS group , TR was significantly shorter than that of control group ( P = 0.002 ) , and OT tended to be prolonged ( 99.0 36.3 s vs. 84.0 37.5 s ) , but not significantly .
-CONCLUSIONS	Preoperative oral rehydration possibly increases circulating blood volume , and shortens the duration of rocuronium effect .
-
-###24829213
-BACKGROUND	Measles vaccine ( MV ) has a greater effect on child survival when administered in early infancy , when maternal antibody may still be present .
-METHODS	To test whether MV has a greater effect on overall survival if given in the presence of maternal measles antibody , we reanalyzed data from 2 previously published randomized trials of a 2-dose schedule with MV given at 4-6 months and at 9 months of age .
-METHODS	In both trials antibody levels had been measured before early measles vaccination .
-RESULTS	In trial I ( 1993-1995 ) , the mortality rate was 0.0 per 1000 person-years among children vaccinated with MV in the presence of maternal antibody and 32.3 per 1000 person-years without maternal antibody ( mortality rate ratio [ MRR ] , 0.0 ; 95 % confidence interval [ CI ] , 0 -.52 ) .
-RESULTS	In trial II ( 2003-2007 ) , the mortality rate was 4.2 per 1000 person-years among children vaccinated in presence of maternal measles antibody and 14.5 per 1000 person-years without measles antibody ( MRR , 0.29 ; 95 % CI , .09 -.91 ) .
-RESULTS	Possible confounding factors did not explain the difference .
-RESULTS	In a combined analysis , children who had measles antibody detected when they received their first dose of MV at 4-6 months of age had lower mortality than children with no maternal antibody , the MRR being 0.22 ( 95 % CI , .07 -.64 ) between 4-6 months and 5 years .
-CONCLUSIONS	Child mortality in low-income countries may be reduced by vaccinating against measles in the presence of maternal antibody , using a 2-dose schedule with the first dose at 4-6 months ( earlier than currently recommended ) and a booster dose at 9-12 months of age .
-BACKGROUND	NCT00168558 .
-
-###25714521
-BACKGROUND	Acute hydrocephalus is a well-known sequela of aneurysmal subarachnoid hemorrhage ( SAH ) .
-BACKGROUND	Controversy exists about whether open microsurgical methods serve to reduce shunt dependency compared with endovascular techniques .
-OBJECTIVE	To determine predictors of shunt-dependent hydrocephalus and functional outcomes after aneurysmal SAH .
-METHODS	A total of 471 patients who were part of a prospective , randomized , controlled trial from 2003 to 2007 were retrospectively reviewed .
-METHODS	All variables including demographic data , medical history , treatment , imaging , and functional outcomes were included as part of the trial .
-METHODS	No additional variables were retrospectively collected .
-RESULTS	Ultimately , 147 patients ( 31.2 % ) required a ventriculoperitoneal shunt ( VPS ) in our series .
-RESULTS	Age , dissecting aneurysm type , ruptured vertebrobasilar aneurysm , Fisher grade , Hunt and Hess grade , admission intraventricular hemorrhage , admission intraparenchymal hemorrhage , blood in the fourth ventricle on admission , perioperative ventriculostomy , and hemicraniectomy were significant risk factors ( P < .05 ) associated with shunt-dependent hydrocephalus on univariate analysis .
-RESULTS	On multivariate analysis , intraventricular hemorrhage and intraparenchymal hemorrhage were independent risk factors for shunt dependency ( P < .05 ) .
-RESULTS	Clipping vs coiling treatment was not statistically associated with VPS after SAH on both univariate and multivariate analyses .
-RESULTS	Patients who did not receive a VPS at discharge had higher Glasgow Outcome Scale and Barthel Index scores and were more likely to be functionally independent and to return to work 72 months after surgery ( P < .05 ) .
-CONCLUSIONS	There is no difference in shunt dependency after SAH among patients treated by endovascular or microsurgical means .
-CONCLUSIONS	Patients in whom shunt-dependent hydrocephalus does not develop after SAH tend to have improved long-term functional outcomes .
-
-###24690370
-BACKGROUND	Acute neural effects of antidepressant medication on emotion processing biases may provide the foundation on which clinical outcomes are based .
-BACKGROUND	Along with effects on positive and negative stimuli , acute effects on neutral stimuli may also relate to antidepressant efficacy , yet these effects are still to be investigated .
-BACKGROUND	The present study therefore examined the impact of a single dose of the selective serotonin reuptake inhibitor escitalopram ( 20 mg ) on positive , negative and neutral stimuli using pharmaco-fMRI .
-METHODS	Within a double-blind , randomized , placebo-controlled crossover design , healthy women completed 2 sessions of treatment administration and fMRI scanning separated by a 1-week washout period .
-RESULTS	We enrolled 36 women in our study .
-RESULTS	When participants were administered escitalopram relative to placebo , left amygdala activity was increased and right inferior frontal gyrus ( IFG ) activity was decreased during presentation of positive pictures ( potentiation of positive emotion processing ) .
-RESULTS	In contrast , escitalopram was associated with decreased left amygdala and increased right IFG activity during presentation of negative pictures ( attenuation of negative emotion processing ) .
-RESULTS	In addition , escitalopram decreased right IFG activity during the processing of neutral stimuli , akin to the effects on positive stimuli ( decrease in negative appraisal ) .
-CONCLUSIONS	Although we used a women-only sample to reduce heterogeneity , our results may not generalize to men .
-CONCLUSIONS	Potential unblinding , which was related to the subjective occurrence of side effects , occurred in the study ; however , manipulation check analyses demonstrated that results were not impacted .
-CONCLUSIONS	These novel findings demonstrate that a single dose of the commonly prescribed escitalopram facilitates a positive information processing bias .
-CONCLUSIONS	These findings provide an important lead for better understanding effects of antidepressant medication .
-
-###25832289
-OBJECTIVE	We explored whether preoperative rosuvastatin could protect the cardiac health of patients with coronary artery disease undergoing emergency , noncardiac surgery .
-METHODS	We randomized 550 noncardiac emergency surgery patients with stable coronary artery disease on long-term statin therapy to treatment with and without preoperative rosuvastatin .
-METHODS	All patients received rosuvastatin after surgery .
-METHODS	We evaluated the incidence of myocardial necrosis and major adverse cardiovascular and cerebrovascular events ( MACCE ) 30 days and 6 months after surgery .
-RESULTS	Creatinine kinase-myocardial band ( CK-MB ) isoform elevations occurred less frequently 12 and 24 h after noncardiac emergency surgery in the experimental group than in the control group ( p = 0.029 ) .
-RESULTS	After surgery , the incidence of MACCE was also lower in the experimental group than in the control group ( p = 0.019 ) .
-RESULTS	The difference was mainly due to the incidence of perioperative myocardial infarction ( p = 0.029 ) .
-RESULTS	Multivariable analysis found that rosuvastatin reload reduced the incidence of MACCE 52 % 6 months after surgery ( p = 0.03 ) .
-CONCLUSIONS	Preoperative rosuvastatin reload therapy decreases the incidence of myocardial necrosis and MACCE after noncardiac emergency surgery in patients with stable coronary artery disease on long-term statin therapy .
-
-###25739248
-OBJECTIVE	To compare the effect , safety , and advantage of flexible fixation with paperboard and pad versus short leg plaster in treating the fifth metatarsal base fracture , and establish the standard of diagnosis and treatment of the fifth metatarsal base fractures in flexible fixation with paperboard and pad .
-METHODS	From June 2010 to March 2013,59 patients with the fifth metatarsal base fracture were treated with paperboard and pad fixation or short leg plaster .
-METHODS	Patients were enrolled and divided into paperboard and pad treatment group ( paperboard group ) and short leg plaster treatment group ( plaster group ) randomly according to the random number table .
-METHODS	In paperboard group , there were 29 cases including 9 males and 20 females with an average age of ( 51.7911.40 ) years old ; the average course of injury was ( 11.596.58 ) hours .
-METHODS	In plaster group , there were 30 cases including 9 males and 21 females with an average age of ( 52.13 +17.34 ) years old ; the average course of injury was ( 11.037.06 ) hours .
-METHODS	According to whether the fracture line across the articular surface , in paperboard group there were 14 cases of type A ,15 of type B ; in plaster group ,16 of type A , 14 of type B.
-METHODS	According to the degree of dislocation , in paperboard group there were 16 cases of degree I ,13 of degree II ; in plaster group ,20 were degree I ,10 were degree II .
-METHODS	Fracture was restored according to the type in manual .
-METHODS	Patients in paperboard group were treated with paperboard and pad , and patients in plaster group were treated with short leg plaster .
-METHODS	Fracture was fixed for 4 to 6 weeks according to fracture healing .
-METHODS	On the 2nd , 4th ,6 th , 8th week and 3rd , 6th month after fixation , patients were followed up , and the foot function score was used to evaluate the function of injured foot .
-METHODS	X-ray of injured foot was taken on the 2nd , 4th , 6th and 8th week were used to assess fracture healing .
-RESULTS	All patients got complete follow-up .
-RESULTS	The X-ray result showed that all fracture reached at clinical healing on the 8th week after fixation without skin ulcer , nonunion and displacement of fracture .
-RESULTS	From the 4th to 8th week after fixation , paperboard group had a higher X-ray score than plaster group , but the difference between two groups had no statistically significance .
-RESULTS	Repeated analysis result showed that there was interact at different time point and between groups , the difference had statistically significance ( P < 0.01 ) .
-RESULTS	The foot function score showed that at all time point , paperboard group had a higher score than plaster group , and on the 2nd , 4th , and 6th week , it had statistically significant difference ( P < 0.01 ) between two groups .
-RESULTS	On the 6th months after fixation , the excellent and good rate of paperboard group was 93.10 % , higher than that of plaster group , which was 86.67 % .
-RESULTS	But it had no statistically difference ( P = 0.483 ) between two groups .
-CONCLUSIONS	Using paperboard and pad fixation to treat the fifth metatarsal base fracture has the advantage of simplicity operating , reliable fixation , satisfactory effects , easily obtainable material .
-
-###24794517
-OBJECTIVE	In the present study , we investigated how the electrical activity in the sensorimotor cortex contributes to improved cognitive processing capabilities and how SMR ( sensorimotor rhythm , 12-15Hz ) neurofeedback training modulates it .
-OBJECTIVE	Previous evidence indicates that higher levels of SMR activity reduce sensorimotor interference and thereby promote cognitive processing .
-METHODS	Participants were randomly assigned to two groups , one experimental ( N = 10 ) group receiving SMR neurofeedback training , in which they learned to voluntarily increase SMR , and one control group ( N = 10 ) receiving sham feedback .
-METHODS	Multiple cognitive functions and electrophysiological correlates of cognitive processing were assessed before and after 10 neurofeedback training sessions .
-RESULTS	The experimental group but not the control group showed linear increases in SMR power over training runs , which was associated with behavioural improvements in memory and attentional performance .
-RESULTS	Additionally , increasing SMR led to a more salient stimulus processing as indicated by increased N1 and P3 event-related potential amplitudes after the training as compared to the pre-test .
-RESULTS	Finally , functional brain connectivity between motor areas and visual processing areas was reduced after SMR training indicating reduced sensorimotor interference .
-CONCLUSIONS	These results indicate that SMR neurofeedback improves stimulus processing capabilities and consequently leads to improvements in cognitive performance .
-CONCLUSIONS	The present findings contribute to a better understanding of the mechanisms underlying SMR neurofeedback training and cognitive processing and implicate that SMR neurofeedback might be an effective cognitive training tool .
-
-###24732630
-BACKGROUND	We ( i ) described variability in colorectal cancer ( CRC ) test use across multiple levels , including physician , clinic , and neighborhood ; and ( ii ) compared the performance of novel cross-classified models versus traditional hierarchical models .
-METHODS	We examined multilevel variation in CRC test use among patients not up-to-date with screening in a large , urban safety net health system ( 2011-2012 ) .
-METHODS	Outcomes included : ( i ) fecal occult blood test ( FOBT ) or ( ii ) colonoscopy and were ascertained using claims data during a 1-year follow-up .
-METHODS	We compared Bayesian ( i ) cross-classified four-level logistic models nesting patients within separate , nonoverlapping `` levels '' ( physicians , clinics , and census tracts ) versus ( ii ) three hierarchical two-level models using deviance information criterion .
-METHODS	Models were adjusted for covariates ( patient sociodemographic factors , driving time to clinic , and census tract poverty rate ) .
-RESULTS	Of 3,195 patients , 157 ( 4.9 % ) completed FOBT and 292 ( 9.1 % ) completed colonoscopy during the study year .
-RESULTS	Patients attended 19 clinics , saw 177 physicians , and resided in 332 census tracts .
-RESULTS	Significant variability was observed across all levels in both hierarchical and cross-classified models that was unexplained by measured covariates .
-RESULTS	For colonoscopy , variance was similar across all levels .
-RESULTS	For FOBT , physicians , followed by clinics , demonstrated the largest variability .
-RESULTS	Model fit using cross-classified models was superior or similar to 2-level hierarchical models .
-CONCLUSIONS	Significant and substantial variability was observed across neighborhood , physician , and clinic levels in CRC test use , suggesting the importance of factors at each of these levels on CRC testing .
-CONCLUSIONS	Future multilevel research and intervention should consider the simultaneous influences of multiple levels , including clinic , physician , and neighborhood .
-
-###24377608
-BACKGROUND	Prevalence of tobacco use is higher in the rural than urban areas of India .
-BACKGROUND	Unlike tobacco cessation clinics located in urban areas , community-based smoking cessation intervention has the potential to reach a wider section of the community to assist in smoking cessation in the rural setting .
-BACKGROUND	The present study aimed to assess the effectiveness of a cessation intervention in rural Kerala state , India .
-METHODS	Current daily smoking resident males in the age group 18-60 years from four community development blocks in rural Kerala were randomly allocated to intervention and control groups .
-METHODS	The intervention group received multiple approaches in which priority was given to face-to-face interviews and telephone counselling .
-METHODS	Initially educational materials on tobacco hazards were distributed .
-METHODS	Further , four rounds of counselling sessions were conducted which included a group counselling with a medical camp as well as individual counselling by trained medical social workers .
-METHODS	The control group received general awareness training on tobacco hazards along with an anti-tobacco leaflet .
-METHODS	Self-reported smoking status was assessed after 6 and 12 months .
-METHODS	Factors associated with tobacco cessation were estimated using binomial regression method .
-RESULTS	Overall prevalence of smoking abstinence was 14.7 % in the intervention and 6.8 % in the control group ( Relative risk : 1.85 , 95 % CI : 1.05 , 3.25 ) .
-RESULTS	A total of 41.3 % subjects in the intervention area and 13.6 % in the control area had reduced smoking by 50 % or more at the end of 12 months .
-RESULTS	Lower number of cigarettes / bidi used , low nicotine dependence and consultation with a doctor for a medical ailment were the statistically significant predictors for smoking cessation .
-CONCLUSIONS	Rigorous approaches for smoking cessation programmes can enhance quit rates in smoking in rural areas of India .
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-###24841833
-BACKGROUND	The benefits of pharmacotherapy with tiotropium HandiHaler 18g for patients with chronic obstructive pulmonary disease ( COPD ) have been previously demonstrated .
-BACKGROUND	However , few data exist regarding the treatment of moderate disease ( Global Initiative for Chronic Obstructive Lung Disease ( GOLD ) stage II ) .
-OBJECTIVE	To determine whether tiotropium improves lung function/patient-reported outcomes in patients with GOLD stage II COPD naive to maintenance therapy .
-METHODS	A randomised 24-week double-blind placebo-controlled trial of tiotropium 18g once daily ( via HandiHaler ) was performed in maintenance therapy-naive patients with forced expiratory volume in 1 s ( FEV1 ) / forced vital capacity ( FVC ) ratio < 0.7 and post-bronchodilator FEV1 50 and < 80 % .
-RESULTS	A total of 457 patients were randomised ( 238 tiotropium , 219 placebo ; mean age 62 years ; FEV1 1.93 l ( 66 % predicted ) ) .
-RESULTS	Tiotropium was superior to placebo in mean change from baseline in post-dose FEV1 area under the curve from 0 to 3h ( AUC0-3h ) at week 24 ( primary endpoint ) : 0.19 vs. -0.03 l ( least-squares mean difference 0.23 l , P < 0.001 ) .
-RESULTS	FVC AUC0-3h , trough and peak FEV1 and FVC were significantly improved with tiotropium versus placebo ( P < 0.001 ) .
-RESULTS	Compared with placebo , tiotropium provided numerical improvements in physical activity ( P = NS ) .
-RESULTS	Physician 's Global Assessment ( health status ) improved ( P = 0.045 ) with less impairment on the Work Productivity and Activity Impairment questionnaire ( P = 0.043 ) at week 24 .
-RESULTS	The incidence of exacerbations , cough , bronchitis and dyspnoea was lower with tiotropium than placebo .
-CONCLUSIONS	Tiotropium improved lung function and patient-reported outcomes in maintenance therapy-naive patients with GOLD stage II COPD , suggesting benefits in initiating maintenance therapy early .
-
-###25305728
-OBJECTIVE	To determine the effect of removing presumptive apoptotic sperm cells from samples from unselected males by means of magnetic activated cell sorting ( MACS ) on live-birth delivery rates after intracytoplasmic sperm injection ( ICSI ) in couples undergoing ovum donation ( OD ) .
-METHODS	Prospective , randomized , triple-blinded , and controlled study .
-METHODS	Private university-affiliated IVF center .
-METHODS	A total of 237 infertile couples undergoing ICSI as part of an OD program .
-METHODS	Semen specimens from the control group were prepared by swim-up .
-METHODS	Samples from the study group were prepared by swim-up followed by MACS and incubation with annexin V-conjugated microbeads to remove annexin V-positive ( AV + ) sperm cells .
-METHODS	Fertilization rates , morphological features of early embryo development , implantation rates , ongoing pregnancy rates , and live-birth rates .
-RESULTS	Similar results were obtained between groups for all the parameters compared : fertilization rates of 75.3 % ( 95 % confidence interval [ CI ] , 71.6-78 .9 ) versus 72.1 % ( 95 % CI , 68.6-75 .7 ) ; percentage of good-quality embryos on day 2 of 53.7 % ( 95 % CI , 50.3-57 .1 ) versus 51.8 % ( 95 % CI , 48.3-55 .3 ) and on day 3 of 54.2 % ( 95 % CI , 50.7-57 .6 ) versus 48.9 % ( 95 % CI , 45.3-52 .4 ) ; implantation rates of 42.2 % ( 95 % CI , 33.8-48 .1 ) versus 40.1 % ( 95 % CI , 34.8-49 .6 ) ; positive beta-hCG tests of 63.2 % ( 95 % CI , 54.7-71 .6 ) versus 68.6 % ( 95 % CI , 60.2-76 .9 ) , and live-birth rates of 48.4 % ( 95 % CI , 39.6-57 .1 ) versus 56.4 % ( 95 % CI , 47.3-65 .5 ) in the MACS versus control group .
-RESULTS	None of the differences reached statistical significance .
-CONCLUSIONS	Applying MACS technology to remove AV + sperm cells from unselected males does not improve the reproductive outcome of ICSI in OD .
-
-###25597462
-BACKGROUND	In-situ audiometry is a hearing aid feature that enables the measurement of hearing threshold levels through the hearing instrument using the built-in sound generator and the hearing aid receiver .
-BACKGROUND	This feature can be used in hearing aid fittings instead of conventional pure-tone audiometry ( PTA ) , particularly in places where no standard audiometric equipment is available .
-BACKGROUND	Differences between conventional and in-situ thresholds are described and discussed for some particular hearing aids .
-BACKGROUND	No previous investigation has measured and compared these differences for a number of current hearing aid models by various manufacturers across a wide range of hearing losses .
-OBJECTIVE	The purpose of this study was to perform a model-based comparison of conventionally and in-situ measured hearing thresholds .
-OBJECTIVE	Data were collected for a range of hearing aid devices to study and generalize the effects that may occur under clinical conditions .
-METHODS	Research design was an experimental and regression study .
-METHODS	A total of 30 adults with sensorineural hearing loss served as test persons .
-METHODS	They were assigned to three subgroups of 10 subjects with mild ( M ) , moderate to severe ( MS ) , and severe ( S ) sensorineural hearing loss .
-METHODS	All 30 test persons underwent both conventional PTA and in-situ audiometry with four hearing aid models by various manufacturers .
-METHODS	The differences between conventionally and in-situ measured hearing threshold levels were calculated and evaluated by an exploratory data analysis followed by a sophisticated statistical modeling process .
-RESULTS	At 500 and 1500 Hz , almost all threshold differences ( conventional PTA minus in-situ data ) were negative , i.e. , in the low to mid frequencies , hearing loss was overestimated by most devices relative to PTA .
-RESULTS	At 4000 Hz , the majority of differences ( 7 of 12 ) were positive , i.e. , in the frequency range above 1500 Hz , hearing loss was frequently underestimated .
-RESULTS	As hearing loss increased ( MMSS ) , the effect of the underestimation decreased .
-RESULTS	At 500 and 1500 Hz , Resound devices showed the smallest threshold deviations , followed by Phonak , Starkey , and Oticon instruments .
-RESULTS	At 4000 Hz , this observed pattern partly disappeared and Starkey and Oticon devices showed a reversed effect with increasing hearing loss ( MMSS ) .
-RESULTS	Because of high standard errors for the estimates , only a few explicit rankings of the devices could be established based on significant threshold differences ( 5 % level ) .
-CONCLUSIONS	Differences between conventional PTA and in-situ threshold levels may be attributed to ( 1 ) frequency , ( 2 ) device/hearing loss , and ( 3 ) calibration/manufacturer effects .
-CONCLUSIONS	Frequency effects primarily resulting in an overestimation of hearing loss by in-situ audiometry in the low and mid frequencies are mainly due to sound drain-off through vents and leaks .
-CONCLUSIONS	Device/hearing loss effects may be due to leakage as well as boundary effects because in-situ audiometry is confined to a limited measurement range .
-CONCLUSIONS	Finally , different calibration approaches may result in different offset levels between PTA and in-situ audiometry calibration .
-CONCLUSIONS	In some cases , the observed threshold differences of up to 10-15 dB may translate to varied hearing aid fittings for the same user depending on how hearing threshold levels were measured .
-
-###25552610
-BACKGROUND	Vitamin D is related to resistance to chronic diseases , physiological parameters and functional measures .
-BACKGROUND	All of these relationships underscore the potential benefits of cholecalciferol or D3 ( nutritional vitamin D ) in cancer .
-BACKGROUND	This is the first study designed to obtain conclusive evidence on the effect of cholecalciferol in advanced patients with cancer .
-BACKGROUND	The main goal is to assess its effects on the patient 's perceived quality of life .
-BACKGROUND	Cholecalciferol 's impact on fatigue and physical performance , as well as its cost utility , will also be assessed .
-METHODS	A randomised triple-blind phase II/III placebo-controlled multicentre trial has been designed .
-METHODS	Patients satisfying the inclusion and exclusion criteria will be randomly assigned to receive cholecalciferol or placebo .
-METHODS	Eligible patients will be adults with a locally advanced or metastatic or inoperable solid cancer in palliative care , who have given signed informed consent and have matched inclusion and exclusion criteria .
-METHODS	The randomisation will be based on a computer-generated procedure and centralised by the pharmacy service of the coordinating centre .
-METHODS	The assigned treatment will be administered by the hospital 's pharmacy to conceal group allocation for patients and healthcare providers .
-METHODS	Cholecalciferol ( 4000 IU/day ) or placebo , starting at day 15 and continuing up to day 42 , will be added to palliative care treatment .
-METHODS	Outpatient visits will be scheduled every 14 days .
-BACKGROUND	Ethical approval was received from the Medical Ethical Commitee of the HUAV ( CEIC-1169 ) .
-BACKGROUND	Participants and their families will receive the research findings which will also be disseminated on local and national media , presented at national and international meetings of the specialty , and published in peer-reviewed scientific journals .
-BACKGROUND	EudraCT : 2013-003478-29 .
-
-###24284414
-BACKGROUND	Adherence to medication is an issue of great importance for patients with ulcerative colitis .
-BACKGROUND	Once daily mesalazine seems to be no worse than divided doses in preventing relapse in remitting patients .
-BACKGROUND	Although this has been attributed to improved adherence , detailed measures of adherence have been lacking from previous studies .
-METHODS	A 1-year substudy was conducted alongside a trial that compared 2 different dosing regimens ( once daily versus three times daily ) of mesalazine for patients in remission with ulcerative colitis .
-METHODS	Participants in the substudy had their adherence monitored electronically using the medication event monitoring system , self-report , and tablet counts .
-METHODS	We compared measures , determined factors associated with adherence and associations between adherence and relapse , modeled adherence over time , and explored behavioral aspects .
-RESULTS	We included 58 participants .
-RESULTS	Adherence was high across all measures ( 89.3 % self-report , 96.7 % tablet counts , and 89.2 % medication event monitoring system ) .
-RESULTS	Agreement between the measures was poor at times .
-RESULTS	Adherence according to the medication event monitoring system best distinguished between the participants who relapsed ( 71.4 % ) and those who remained in remission ( 93.4 % ) , although this difference was not statistically discernible at the 5 % level .
-RESULTS	Adherence deteriorated over the study period , with three times daily participants generally less adherent than once-daily participants ( odds ratio , 0.03 ; 95 % confidence interval , 0.01-0 .08 ) .
-RESULTS	Adherence was higher on weekdays ( odds ratio , 1.47 ; 95 % confidence interval , 1.31-1 .65 ) and around clinic visit dates ( odds ratio , 1.43 ; 95 % confidence interval , 1.18-1 .72 ) .
-CONCLUSIONS	Simple dosing regimens are preferable to multiple daily dosing regimens .
-CONCLUSIONS	Electronic monitoring of adherence should be used more often in clinical studies .
-CONCLUSIONS	Self-reported adherence and tablet counts may underestimate adherence .
-CONCLUSIONS	Adherence declined over time , and adherence was generally lower and more varied for those allocated to the three times daily regimen .
-
-###25201358
-BACKGROUND	The role of adjuvant chemotherapy for patients with rectal cancer is controversial , especially when used after preoperative chemoradiotherapy .
-BACKGROUND	Fluoropyrimidine-based adjuvant chemotherapy , including fluorouracil and leucovorin , has been widely used ; however , the addition of oxaliplatin to fluorouracil and leucovorin ( FOLFOX ) , a standard adjuvant regimen for colon cancer , has not been tested in rectal cancer .
-BACKGROUND	We aimed to compare the efficacy and safety of adjuvant fluorouracil and leucovorin with that of FOLFOX in patients with locally advanced rectal cancer after preoperative chemoradiotherapy .
-METHODS	In this open-label , multicentre , phase 2 , randomised trial , patients with postoperative pathological stage II ( ypT3-4N0 ) or III ( ypTanyN1-2 ) rectal cancer after preoperative fluoropyrimidine-based chemoradiotherapy and total mesorectal excision were recruited and randomly assigned ( 1:1 ) via a web-based software platform to receive adjuvant chemotherapy with either four cycles of fluorouracil and leucovorin ( fluorouracil 380 mg/m ( 2 ) and leucovorin 20 mg/m ( 2 ) on days 1-5 , every 4 weeks ) or eight cycles of FOLFOX ( oxaliplatin 85 mg/m ( 2 ) , leucovorin 200 mg/m ( 2 ) , and fluorouracil bolus 400 mg/m ( 2 ) on day 1 , and fluorouracil infusion 2400 mg/m ( 2 ) for 46 h , every 2 weeks ) .
-METHODS	Stratification factors were pathological stage ( II vs III ) and centre .
-METHODS	Neither patients nor investigators were masked to group assignment .
-METHODS	The primary endpoint was 3-year disease-free survival , analysed by intention to treat .
-METHODS	This study is fully enrolled , is in long-term follow-up , and is registered with ClinicalTrials.gov , number NCT00807911 .
-RESULTS	Between Nov 19 , 2008 , and June 12 , 2012 , 321 patients were randomly assigned to fluorouracil and leucovorin ( n = 161 ) and FOLFOX ( n = 160 ) .
-RESULTS	141 ( 95 % ) of 149 patients in the fluorouracil plus leucovorin group and 141 ( 97 % ) of 146 in the FOLFOX group completed all planned cycles of adjuvant treatment .
-RESULTS	Median follow-up was 382 months ( IQR 264-506 ) .
-RESULTS	3-year disease-free survival was 716 % ( 95 % CI 646-786 ) in the FOLFOX group and 629 % ( 554-704 ) in the fluorouracil plus leucovorin group ( hazard ratio 0657 , 95 % CI 0434-0994 ; p = 0047 ) .
-RESULTS	Any grade neutropenia , thrombocytopenia , fatigue , nausea , and sensory neuropathy were significantly more common in the FOLFOX group than in the fluorouracil plus leucovorin group ; however , we noted no significant difference in the frequency of these events at grade 3 or 4 .
-RESULTS	The most common grade 3 or worse adverse events were neutropenia ( 38 [ 26 % ] of 149 patients in the fluorouracil plus leucovorin group vs 52 [ 36 % ] of 146 patients in the FOLFOX group ) , leucopenia ( eight [ 5 % ] vs 12 [ 8 % ] ) , febrile neutropenia ( four [ 3 % ] vs one [ < 1 % ] ) , diarrhoea ( four [ 3 % ] vs two [ 1 % ] ) , and nausea ( one [ < 1 % ] vs two [ 1 % ] ) .
-CONCLUSIONS	Adjuvant FOLFOX improves disease-free survival compared with fluorouracil plus leucovorin in patients with locally advanced rectal cancer after preoperative chemoradiotherapy and total mesorectal excision , and warrants further investigation .
-BACKGROUND	Korea Healthcare Technology R&D Project ( South Korean Ministry of Health and Welfare ) .
-
-###24576886
-OBJECTIVE	To investigate the efficacy and safety of corneal collagen cross-linking ( CXL ) with photoactivated riboflavin ( photoactivated chromophore for infectious keratitis [ PACK ] - CXL ) in the management of infectious keratitis with corneal melting .
-METHODS	Prospective clinical trial .
-METHODS	Forty eyes from 40 patients with advanced infectious keratitis and coexisting corneal melting .
-METHODS	Twenty-one patients ( 21 eyes ) underwent PACK-CXL treatment in addition to antimicrobial therapy .
-METHODS	The control group consisted of 19 patients ( 19 eyes ) who received only antimicrobial therapy .
-METHODS	The slit-lamp characteristics of the corneal ulceration , corrected distance visual acuity , duration until healing , and complications were documented in each group .
-METHODS	The Mann-Whitney U test was used for statistical analysis .
-METHODS	P values less than 0.05 were considered statistically significant .
-RESULTS	The average time until healing was 39.76 18.22 days in the PACK-CXL group and 46.05 27.44 days in the control group ( P = 0.68 ) .
-RESULTS	After treatment and healing , corrected distance visual acuity was 1.64 0.62 in the PACK-CXL group and 1.67 0.48 in the control group ( P = 0.68 ) .
-RESULTS	The corneal ulceration 's width and length was significantly bigger in the PACK-CXL group ( P = 0.004 and P = 0.007 ) .
-RESULTS	Three patients in the control group demonstrated corneal perforation ; infection recurred in 1 of them .
-RESULTS	No serious complications occurred in the PACK-CXL group .
-CONCLUSIONS	Corneal CXL with photoactivated riboflavin did not shorten the time to corneal healing ; however , the complication rate was 21 % in the control group , whereas there was no incidence of corneal perforation or recurrence of the infection in the PACK-CXL group .
-CONCLUSIONS	These results indicate that PACK-CXL may be an effective adjuvant therapy in the management of severe infectious keratitis associated with corneal melting .
-
-###25650816
-OBJECTIVE	Sweet esophagectomy is performed widely in China , while the Ivor-Lewis procedure , with potential benefit of an extended lymphadenectomy , is limitedly conducted owing to concern for a higher risk for morbidity .
-OBJECTIVE	Thus , the role of the Ivor-Lewis procedure for thoracic esophageal cancer needs further investigation .
-OBJECTIVE	To determine whether Ivor-Lewis esophagectomy is associated with increased postoperative complications compared with the Sweet procedure .
-METHODS	A randomized clinical trial was conducted from May 2010 to July 2012 at Fudan University Shanghai Cancer Center , Shanghai , China , of 300 patients with resectable squamous cell carcinoma in the middle and lower third of the thoracic esophagus .
-METHODS	Intent-to-treat analysis was performed .
-METHODS	Patients were randomly assigned to receive either the Ivor-Lewis ( n = 150 ) or Sweet ( n = 150 ) esophagectomy .
-METHODS	The primary outcome of this clinical trial was operative morbidity ( any surgical or nonsurgical complications ) .
-METHODS	Secondary outcomes included oncologic efficacy ( number of lymph nodes resected and positive lymph nodes ) , postoperative mortality ( 30-day and in-hospital mortality ) , and patient discharge .
-RESULTS	Resection without macroscopical residual ( R0/R1 ) was achieved in 149 of 150 patients in each group .
-RESULTS	Although there was no significant difference between the 2 groups regarding the incidence of each single complication , a significantly higher morbidity rate was found in the Sweet group ( 62 of 150 [ 41.3 % ] ) than in the Ivor-Lewis group ( 45 of 150 [ 30 % ] ) ( P = .04 ) .
-RESULTS	More patients in the Sweet group ( 8 of 150 [ 5.3 % ] ) received reoperations than in the Ivor-Lewis group ( 1 of 150 [ 0.7 % ] ) ( P = .04 ) .
-RESULTS	The median hospital stay was 18 days in the Sweet group vs 16 days in the Ivor-Lewis group ( P = .002 ) .
-RESULTS	Postoperative mortality rates in the Ivor-Lewis ( 1 of 150 ) and Sweet ( 3 of 150 ) groups were 0.7 % and 2.0 % , respectively ( P = .25 ) .
-RESULTS	More lymph nodes were removed during Ivor-Lewis esophagectomy than during the Sweet procedure ( 22 vs 18 , P < .001 ) .
-CONCLUSIONS	Early results of this study demonstrate that the Ivor-Lewis procedure can be performed with lower rates of postoperative complications and more lymph node retrieval .
-CONCLUSIONS	Ivor-Lewis and Sweet esophagectomies are both safe procedures with low operative mortalities .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01047111 .
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-###24445878
-BACKGROUND	Hypotensive anesthesia is routinely used during craniosynostosis corrections to reduce blood loss .
-BACKGROUND	Noting that cerebral oxygenation levels often fell below recommended levels , the authors sought to measure the effects of hypotensive versus standard anesthesia on blood transfusion rates .
-METHODS	One hundred children undergoing craniosynostosis corrections were randomized prospectively into two groups : a target mean arterial pressure of either 50 mm Hg or 60 mm Hg .
-METHODS	Aside from anesthesiologists , caregivers were blinded and strict transfusion criteria were followed .
-METHODS	Multiple variables were analyzed , and appropriate statistical testing was performed .
-RESULTS	The hypotensive and standard groups appeared similar , with no statistically significant differences in mean age ( 46.5 months versus 46.5 months ) , weight ( 19.25 kg versus 19.49 kg ) , procedure [ anterior remodeling ( 34 versus 31 ) versus posterior ( 19 versus 16 ) ] , or preoperative hemoglobin level ( 13 g/dl versus 12.9 g/dl ) .
-RESULTS	Intraoperative mean arterial pressures differed significantly ( 56 mm Hg versus 66 mm Hg ; p < 0.001 ) .
-RESULTS	The captured cell saver amount was lower in the hypotensive group ( 163 cc versus 204 cc ; p = 0.02 ) , yet no significant differences were noted in postoperative hemoglobin levels ( 8.8 g/dl versus 9.3 g/dl ) .
-RESULTS	Fifteen of 100 patients ( 15 percent ) received allogenic transfusions , but no statistically significant differences were noted in transfusion rates between the hypotensive [ nine of 53 ( 17.0 percent ) ] and standard anesthesia [ six of 47 ( 13 percent ) ] group ( p = 0.056 ) .
-CONCLUSIONS	No significant difference in transfusion requirements was found between hypotensive and standard anesthesia during craniosynostosis corrections .
-CONCLUSIONS	Considering potential benefits of improved cerebral blood flow and total body perfusion , surgeons might consider performing craniosynostosis corrections without hypotension .
-METHODS	Therapeutic , II .
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-###25159737
-OBJECTIVE	Sensorimotor rhythm patterns in patients with lower limb amputations might be altered because of reorganization of the sensorimotor cortices .
-OBJECTIVE	The authors evaluated the sensorimotor rhythm of motor imagery ( MI ) in healthy subjects and patients with lower limb amputations .
-OBJECTIVE	In addition , the authors investigated whether transcranial direct current stimulation ( tDCS ) could modulate sensorimotor rhythm control .
-METHODS	Six healthy subjects and six patients with lower limb amputations were assigned to receive anodal , cathodal , or sham tDCS over the foot motor area in a randomized order .
-METHODS	The authors evaluated event-related desynchronization and event-related synchronization ( ERS ) of unilateral hand and bilateral foot MI before and after tDCS .
-RESULTS	Beta ERS of foot MI in patients with lower limb amputations was significantly lesser than that in healthy subjects .
-RESULTS	Compared with sham stimulation , cathodal tDCS enhanced beta ERS of foot MI in patients with lower limb amputations .
-RESULTS	In contrast , anodal tDCS decreased beta ERS of foot MI in healthy subjects .
-CONCLUSIONS	This is the first study to demonstrate that cathodal tDCS can enhance a weak beta ERS of foot MI in patients with lower limb amputations .
-CONCLUSIONS	These findings might contribute in improving the effectiveness of sensorimotor rhythm-based brain computer interface for gait restoration after lower limb amputation .
-
-###25072647
-OBJECTIVE	To determine whether topical aqueous suppressants affect the duration of pure expansile intraocular gas in nonvitrectomized eyes .
-METHODS	A prospective randomized controlled trial was performed on nonvitrectomized patients undergoing retinal detachment repair with scleral buckle or pneumatic retinopexy using 0.3 mL of 100 % perfluoropropane ( C3F8 ) gas tamponade .
-METHODS	Eyes were randomly assigned to receive topical dorzolamide 2 % and timolol 0.5 % twice daily postoperatively until gas dissolution or to observation .
-RESULTS	Twenty-one patients met all inclusion and exclusion criteria .
-RESULTS	Twelve were randomized to the control group and nine to the dorzolamide-timolol group .
-RESULTS	In the dorzolamide-timolol group , mean intraocular pressure was 17.4 on postoperative Day 1 and 12.5 on postoperative Week 1 ( P = 0.03 ) .
-RESULTS	In the control group , mean intraocular pressure was 14.5 on postoperative Day 1 and 15.1 on postoperative Week 1 ( P = 0.73 ) .
-RESULTS	The mean duration of C3F8 was 37.8 days in the dorzolamide-timolol group and 40.4 days in the control group ( P = 0.70 ) .
-CONCLUSIONS	Topical aqueous suppression does not seem to have a significant effect on the duration of pure expansile intraocular C3F8 in nonvitrectomized eyes after pneumatic retinopexy or scleral buckling .
-
-###24467828
-BACKGROUND	Inhibitors of the phosphatidylinositol-3-kinase / protein kinase B/mammalian target of rapamycin ( PI3K/AKT/mTOR ) pathway can overcome endocrine resistance in estrogen receptor ( ER ) - positive breast cancer , but companion diagnostics indicating PI3K/AKT/mTOR activation and consequently endocrine resistance are lacking .
-BACKGROUND	PIK3CA mutations frequently occur in ER-positive breast cancer and result in PI3K/AKT/mTOR activation in vitro .
-BACKGROUND	Nevertheless , the prognostic and treatment-predictive value of these mutations in ER-positive breast cancer is contradictive .
-BACKGROUND	We tested the clinical validity of PIK3CA mutations and other canonic pathway drivers to predict intrinsic resistance to adjuvant tamoxifen .
-BACKGROUND	In addition , we tested the association between these drivers and downstream activated proteins .
-METHODS	Primary tumors from 563 ER-positive postmenopausal patients , randomized between adjuvant tamoxifen ( 1 to 3 years ) versus observation were recollected .
-METHODS	PIK3CA hotspot mutations in exon 9 and exon 20 were assessed with Sequenom Mass Spectometry .
-METHODS	Immunohistochemistry was performed for human epidermal growth factor receptor 2 ( HER2 ) , phosphatase and tensin homolog ( PTEN ) , and insulin-like growth factor 1 receptor ( IGF-1R ) .
-METHODS	We tested the association between these molecular alterations and downstream activated proteins ( like phospho-protein kinase B ( p-AKT ) , phospho-mammalian target of rapamycin ( p-mTOR ) , p-ERK1 / 2 , and p-p70S6K ) .
-METHODS	Recurrence-free interval improvement with tamoxifen versus control was assessed according to the presence or absence of canonic pathway drivers , by using Cox proportional hazard models , including a test for interaction .
-RESULTS	PIK3CA mutations ( both exon 9 and exon 20 ) were associated with low tumor grade .
-RESULTS	An enrichment of PIK3CA exon 20 mutations was observed in progesterone receptor - positive tumors .
-RESULTS	PIK3CA exon 20 mutations were not associated with downstream-activated proteins .
-RESULTS	No significant interaction between PIK3CA mutations or any of the other canonic pathway drivers and tamoxifen-treatment benefit was found .
-CONCLUSIONS	PIK3CA mutations do not have clinical validity to predict intrinsic resistance to adjuvant tamoxifen and may therefore be unsuitable as companion diagnostic for PI3K/AKT/mTOR inhibitors in ER - positive , postmenopausal , early breast cancer patients .
-
-###24625034
-BACKGROUND	Osteoarthritis of the first metatarsophalangeal joint ( hallux rigidus ) leads to pain and poor function and mobility .
-BACKGROUND	Arthrodesis is the gold standard treatment for end-stage disease .
-BACKGROUND	Total joint arthroplasties have been attempted , but early loosening has been attributed to dorsally directed shear forces on the metatarsal component .
-BACKGROUND	Metallic proximal phalangeal hemiarthroplasty theoretically avoids this .
-BACKGROUND	Whilst early results are promising , no comparative trials exist comparing this to arthrodesis .
-METHODS	The primary objectives are to determine the range of outcome scores between the two treatment arms ( to inform a power calculation ) .
-METHODS	Outcome measures will include the MOXFQ , AOFAS-Hallux and EuroQol EQ-5D-5 L. Secondary objectives are to determine the accrual rate , dropout rate and trial acceptability to both patients and surgeons .
-METHODS	These data will allow the development of a larger trial with longer follow-up .
-METHODS	This is a prospective randomised controlled single-centre study comparing proximal phalanx hemiarthroplasty ( AnaToemic , Arthrex Ltd. , Sheffield , UK ) with arthrodesis ( 15 patients in each arm ) .
-METHODS	Randomisation will be performed using a 1:1 allocation ratio in blocks of six.Patients meeting the eligibility criteria will be recruited from three foot and ankle consultant surgeon 's clinics ( East Lancashire Hospitals NHS Trust ) .
-METHODS	If agreeable , informed consent will be obtained before patients are randomised.The outcome measure scores will be completed pre-operatively and repeated at 6 weeks , 3 months and 12 months .
-METHODS	A radiological review will be performed at 6 weeks and 12 months to determine rates of loosening ( hemiarthroplasty ) and union ( arthrodesis ) .
-METHODS	Data on length of stay , return to work , complications and re-operation rates will also be collected.The analysis will compare the change in outcome scores between treatment groups at all follow-up time points .
-METHODS	Scores will be compared using a Student t-test , adjusting for scores at baseline.This study will be conducted in accordance with the current revision of the Declaration of Helsinki ( 1996 ) and the ICH-GCP Guideline ( International Conference on Harmonisation , Good Clinical Practice , E6 ( R1 ) , 1996 ) .
-METHODS	This study has been approved by the sponsor , the Trust Research & Development office .
-METHODS	Ethical approval has been received from the National Research Ethics Service ( North East : 12/NE/0385 for protocol version 5.3 dated 3 June 2013 ) .
-BACKGROUND	Current Controlled Trials ISRCTN88273654 .
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-###26125448
-BACKGROUND	Selumetinib ( AZD6244 , ARRY-142886 ) + docetaxel increases median overall survival ( OS ) and significantly improves progression-free survival ( PFS ) and objective response rate ( ORR ) compared with docetaxel alone in patients with KRAS mutant , stage IIIB/IV non-small-cell lung cancer ( NSCLC ; NCT00890825 ) .
-METHODS	Retrospective analysis of OS , PFS , ORR and change in tumour size at week 6 for different sub-populations of KRAS codon mutations .
-RESULTS	In patients receiving selumetinib + docetaxel and harbouring KRAS G12C or G12V mutations there were trends towards greater improvement in OS , PFS and ORR compared with other KRAS mutations .
-CONCLUSIONS	Different KRAS mutations in NSCLC may influence selumetinib/docetaxel sensitivity .
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-###24890443
-OBJECTIVE	Minimal sedation obviates patient recovery burdens , but intolerable pain limits success of cecal intubation .
-OBJECTIVE	Painless or minimally uncomfortable insertion ensures success of cecal intubation , current patient satisfaction , and willingness to repeat future colonoscopy with minimal sedation .
-OBJECTIVE	Water immersion ( WI ) and water exchange ( WE ) , when separately compared with air insufflation ( AI ) , significantly reduced insertion pain .
-OBJECTIVE	To assess comparative effectiveness , we conducted a randomized controlled trial with head-to-head comparison of these three methods .
-OBJECTIVE	We hypothesized that WE could produce the highest proportion of patients reporting painless insertion .
-METHODS	This prospective patient-blinded trial ( NCT01535326 ) enrolled minimally sedated ( 25mg intramuscular meperidine ) patients randomized to AI , WI , or WE ( 90 patients/group ) to aid insertion .
-METHODS	The previously validated primary outcome was the proportion of patients reporting painless insertion .
-RESULTS	Painless insertion was reported by 30.0 % ( AI ) , 43.3 % ( WI ) , and 61.1 % ( WE ) of patients ( P < 0.001 ) .
-RESULTS	Multivariate logistic regression analysis revealed that , after adjusting for gender , body mass index , abdominal compression , position change , insertion time to cecum , and length of scope at cecum , only WE was significantly associated with painless insertion compared with AI ( odds ratio ( OR ) = 0.08 , 95 % confidence interval ( CI ) = 0.03-0 .24 , P < 0.001 ) or WI ( OR = 0.14 , 95 % CI = 0.05-0 .40 , P < 0.001 ) .
-RESULTS	Adenoma detection rate ( ADR ) in the right ( cecum and ascending ) colon was 11.1 % ( AI ) , 14.4 % ( WI ) , and 26.7 % ( WE ) ( P = 0.015 ) .
-RESULTS	The limitations included single site study with unblinded colonoscopist and assistant .
-CONCLUSIONS	This head-to-head comparison of AI vs. WI vs. WE confirmed that WE was superior to WI and AI , with a significantly greater proportion of patients reporting painless insertion .
-CONCLUSIONS	The significantly higher ADR in the right colon in the WE group warrants further investigations .
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-###24497599
-BACKGROUND	One of the most common and severe complications affecting peritoneal dialysis ( PD ) patients is exit-site infection of the peritoneal catheter ; it is therefore of vital importance to prevent it .
-BACKGROUND	This complication has a negative impact on the success of the technique .
-BACKGROUND	In spite of this , there are no clear guidelines concerning how to take care of the exit site .
-BACKGROUND	The objective of this study was to assess the efficacy of polyhexanide in preventing exit-site infection over a 12-month period .
-METHODS	We designed a single-center , prospective , open-labeled , randomized controlled clinical trial with parallel groups .
-METHODS	Requirements for participation in the study included implantation of the peritoneal catheter at least six weeks before entering the study and no infectious complications requiring either hospital admission or antibiotic treatment for at least three months before entering into the study .
-METHODS	Patients were randomized to be daily cured as follows : Group A : traditional care with saline serum and povidone-iodine ; and Group B : polyhexanide solution .
-METHODS	Exit sites were evaluated at baseline and every four to six weeks or if any event occurred , according to the Twardowski criteria .
-RESULTS	Of the 60 included patients , 46 completed the 12-month follow-up period .
-RESULTS	Six underwent transplantation , five died and three were transferred to hemodialysis ( HD ) .
-RESULTS	The treatment was well tolerated , with no side effects nor abandonments due to such effects .
-RESULTS	Throughout the study period , six patients ( 20 % ) undergoing traditional care and only two ( 6,7 % ) receiving polyhexanide developed an exit-site infection ( p = 0.032 ) .
-RESULTS	There were a total number of 12 infections ; nine occurred in patients following the traditional approach and only three in patients treated with polyhexanide ( p = 0.037 ) .
-RESULTS	The germs responsible for the infections were : S. aureus ( six cases ) , Corynebacterium jeikeium ( two cases ) and P. aeruginosa ( one case ) in the saline serum and povidone-iodine group and P. aeruginosa ( three cases ) in the polyhexanide group .
-RESULTS	The mean rate of exit-site infection was 1 episode/36 .6 patient-months for the traditional care group and 1 episode/102 .7 patient-months for the polyhexanide group ( p = 0.017 ) .
-RESULTS	Patients following the traditional treatment required fewer days to get infected than those using polyhexanide ( p = 0.033 ; log rank : 4.2 ) .
-CONCLUSIONS	These results show that using polyhexanide is efficient for the prevention of exit-site infections .
-CONCLUSIONS	Patients treated with this product suffer from fewer infections and need more time to become infected .
-CONCLUSIONS	Polyhexanide application is painless , no allergies have been described and it is well tolerated by patients .
-CONCLUSIONS	We therefore propose that it may be used routinely from now on for the care of healthy exit site .
-
-###25200848
-BACKGROUND	Periprocedural ( 6 h pre - and 24 h post-angiography ) hemofiltration appears to effectively prevent contrast-induced nephropathy ( CIN ) in chronic kidney disease ( CKD ) patients undergoing coronary angiography .
-BACKGROUND	However , this procedure over-uses medical resources , and the cessation of hemofiltration during coronary angiography results in persistent renal injury .
-BACKGROUND	In comparison , simultaneous hemofiltration performed only during coronary angiography requires fewer medical resources and can provide instantaneous protection against CIN .
-METHODS	Sixty-eight CKD patients ( serum creatinine , 2.511.15 mg/dL ) undergoing coronary angiography were randomized in a 1:2 ratio to receive either periprocedural ( n = 23 ) or simultaneous ( n = 45 ) hemofiltration .
-METHODS	The expected CIN rate was similar for the two groups ( 41.3 % versus 40.0 % , p = 0.769 ) .
-RESULTS	On day 3 after contrast exposure , four and seven patients in the periprocedural and simultaneous groups , respectively experienced CIN ( 17.4 % versus 15.6 % , p = 0.846 ) .
-RESULTS	On days 5-30 , seven and three patients in the periprocedural and simultaneous groups , respectively experienced CIN ( 30.4 % versus 6.7 % , p = 0.009 ) .
-RESULTS	The serum creatinine levels of patients in the periprocedural group transiently decreased on day 1 and persistently increased during days 5-30 compared with the simultaneous group .
-RESULTS	This difference between the two groups in terms of creatinine levels over time was statistically significant ( F statistic = 6.830 ; p = 0.001 , by ANCOVA ) .
-RESULTS	The cost of hemofiltration was doubled in the periprocedural group ( $ 106683 versus $ 50440 , p < 0.001 ) .
-CONCLUSIONS	Simultaneous hemofiltration provide equal early ( day 3 ) and better late-stage ( days 5-30 ) renal protection against CIN at a significantly lower cost compared with periprocedural hemofiltration .
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-###25415738
-OBJECTIVE	The purpose of this study is to evaluate the effectiveness of electromagnetic tracking in assisting CT-guided liver biopsies .
-METHODS	This was a single-center prospective randomized controlled trial comparing nonfluoroscopic CT-guided liver biopsy using an advance-and-scan technique with and without electromagnetic tracking .
-METHODS	Fifty patients with a liver lesion referred for biopsy ( women , 52 % ; mean age , 59.7 years ; mean lesion size , 3.6 cm ) were enrolled in the study and were randomly assigned to either arm .
-METHODS	The primary and secondary objectives were to assess and quantify differences in the number of intraprocedural scans , cumulative effective radiation dose , number of needle manipulations , and procedure time from skin-stick to the target lesion with and without assistance .
-RESULTS	Electromagnetic tracking significantly decreased the number of scans , effective radiation dose , number of manipulations per procedure , and time from skin-stick to the target lesion .
-RESULTS	The ratio of the number of scans ( electromagnetic tracking to control ) was 0.55 ( 95 % CI , 0.42-0 .73 ; p < 0.0001 ) .
-RESULTS	The mean difference in effective radiation dose ( electromagnetic tracking-control ) was -4.7 mSv ( 95 % CI , -7.01 to -2.44 mSv ; p = 0.0001 ) , and the median difference was -5.1 mSv ( 95 % CI , -7.01 to -3.56 mSv ; p < 0.0001 ) .
-RESULTS	The ratio of the number of manipulations ( electromagnetic tracking to control ) was 0.36 ( 95 % CI , 0.24-0 .54 ; p < 0.0001 ) .
-RESULTS	The mean difference for the time from skin-stick to the target lesion was -247.6 seconds ( 95 % CI , -394.34 to -100.83 seconds ; p = 0.0014 ) and the median difference was -253.0 seconds ( 95 % CI , -325.00 to -124.00 seconds ; p = 0.0001 ) .
-CONCLUSIONS	Electromagnetic tracking assistance has the potential to decrease the number of intraprocedural CT scans and needle manipulations and to reduce patient radiation dose during CT-guided liver biopsy .
-
-###25275271
-OBJECTIVE	This report from the LEADER ( Liraglutide Effect and Action in Diabetes : Evaluation of Cardiovascular Outcome Results ) trial describes baseline lipase and amylase activity in type 2 diabetic subjects without acute pancreatitis symptoms before randomization to the glucagonlike peptide analog liraglutide or placebo .
-METHODS	The LEADER is an international randomized placebo-controlled trial evaluating the cardiovascular safety of liraglutide in 9340 type 2 diabetic patients at high cardiovascular risk .
-METHODS	Fasting lipase and amylase activity was assessed at baseline , before receiving liraglutide or placebo , using a commercial assay ( Roche ) with upper limit of normal values of 63 U/L for lipase and 100 U/L for amylase .
-RESULTS	Either or both enzymes were above the upper limit of normal in 22.7 % of subjects ; 16.6 % ( n = 1540 ) had an elevated lipase level ( including 1.2 % > 3-fold elevated ) , and 11.8 % ( n = 1094 ) had an elevated amylase level ( including 0.2 % > 3-fold elevated ) .
-RESULTS	In multivariable regression models , severely reduced kidney function was associated with the largest effect on increasing activity of both .
-RESULTS	However , even among subjects with normal kidney function , 12.2 % and 7.7 % had elevated lipase and amylase levels .
-CONCLUSIONS	In this large study of type 2 diabetic patients , nearly 25 % had elevated lipase or amylase levels without symptoms of acute pancreatitis .
-CONCLUSIONS	The clinician must take these data into account when evaluating abdominal symptoms in type 2 diabetic patients .
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-###24561769
-BACKGROUND	Exacerbations of bronchial asthma usually occur in the autumn .
-BACKGROUND	To our knowledge , however , the effectiveness of drugs for preventing exacerbations of asthma in the autumn has not been studied previously , except for leukotriene receptor antagonists and Omalizmab .
-METHODS	This study compared the prophylactic effectiveness of suplatast tosilate with that of mequitazine in children with asthma symptoms , which is usually exacerbated in the autumn .
-METHODS	The study group comprised 27 children aged 2 to 15 years who required treatment for asthmatic attacks during the past year and tested positive at least for mite allergen in the preceding autumn .
-METHODS	The subjects were randomly assigned to receive either suplatast or mequitazine .
-METHODS	The primary endpoint of this study was the number of days without symptoms during the 8 weeks of treatment .
-METHODS	In addition , the Japanese Pediatric Asthma Control Program ( JPAC ) scores were also recorded every 2 weeks in each group .
-RESULTS	Overall , 14 patients received suplatast , and 13 received mequitazine for 8 weeks from September through early October .
-RESULTS	During follow-up , the number of days without symptoms and the total JPAC scores did not differ significantly between the groups .
-RESULTS	However , as compared with weeks 1 to 2 of treatment , the mean number of days without symptoms during weeks 7 to 8 increased significantly in only the suplatast group ( 8.6 vs. 11.5 days ; p = 0.004 ) .
-CONCLUSIONS	Our results suggest that short-term additional treatment with suplatast is useful for preventing asthma symptoms in children with asthma , which is usually exacerbated in the autumn .
-
-###24597251
-OBJECTIVE	The aim of this prospective randomized controlled cross sectional study was to evaluate the effect of a six month tibolone treatment in healthy postmenopausal women on biochemical CVD markers by calculating the changes of the blood serum levels of total cholesterol ( TC ) , low-density lipoprotein ( LDL ) , high-density lipoprotein ( HDL ) , triglycerides ( Tg ) , high-sensitivity C-reactive protein ( hsCRP ) , homocysteine ( Hcy ) , and endothelin-1 ( ET-1 ) at the beginning of the treatment and after six months .
-METHODS	Fifty-two healthy postmenopausal women were enrolled in a prospective , randomized , case-controlled outpatient trial .
-METHODS	Group 1 ( n = 26 ) received 2,5 mg/d tibolone for six months , while Group 2 ( n = 26 ) received no treatment .
-METHODS	Serum levels ofTC , LDL , HDL , Tg , hsCRP , Hcy , and ET-1 were evaluated at baseline and after six months .
-RESULTS	The two groups did not statistically differ at baseline characteristics .
-RESULTS	In Group 1 tibolone treatment decreased significantly TC ( p = 0.01 ) , HDL ( p < 0.001 ) , and Tg ( p < 0.001 ) serum levels while a significant increase ofhsCRP ( p < 0.001 ) was observed .
-RESULTS	Finally no changes were noticed on LDL , Hcy , and ET-1 serum levels .
-RESULTS	Regarding Group 2 , no changes were observed .
-CONCLUSIONS	Short-term tibolone treatment in healthy postmenopausal women exerts a mixed action , acting beneficially in some markers ( TC , LDL , Tg , Hcy , and ET-1 ) where as detrimentally in others ( HDL , hsCRP ) .
-
-###24327135
-BACKGROUND	Few previous studies have examined the influence of instrumental and emotional social support on physical activity ( PA ) longitudinally in underserved adolescents .
-OBJECTIVE	This longitudinal study was a secondary analysis of the Active by Choice Today ( ACT ) trial examining whether instrumental social support predicts increases in PA in underserved adolescents , above and beyond emotional social support provided by family or peers .
-METHODS	Students in the sixth grade ( N = 1,422 , 73 % African American , 54 % female , M age = 11years ) in the ACT trial participated .
-METHODS	At baseline and 19weeks , previously validated measures of social support ( family instrumental , family emotional , and peer emotional ) were completed and moderate-to-vigorous PA ( MVPA ) was assessed using 7-day accelerometry estimates .
-RESULTS	A mixed ANCOVA demonstrated that baseline ( p = 0.02 ) and change in family instrumental support ( p = 0.01 ) , but not emotional support from family or peers , predicted increases in MVPA across a 19-week period .
-CONCLUSIONS	Future interventions in underserved adolescents should enhance opportunities for instrumental support for PA. .
-
-###26069138
-OBJECTIVE	We aimed to determine whether head elevation during combined spinal-epidural anesthesia ( CSE ) and Caesarean section provided improved hemodynamics and appropriate sensory block height .
-METHODS	Forty-four parous women undergoing CSE for elective Caesarean section were randomly assigned to one of two groups : right lateral ( group L ) or right lateral and head elevated ( group HE ) position , for insertion of the block .
-METHODS	Patients were positioned in the supine wedged position ( group L ) or the left lateral and head elevated position ( group HE ) until a block height of T5 to light touch was reached .
-METHODS	Group HE was then turned to the supine wedged position with maintenance of head elevation until the end of surgery .
-METHODS	Hemodynamics , including the incidence of hypotension , ephedrine dose required , and characteristics of the sensory blocks were analyzed .
-RESULTS	The incidence of hypotension ( 16 versus 7 , p = 0.0035 ) and the required dose of ephedrine [ 24 ( 0-40 ) versus 0 ( 0-20 ) , p < 0.0001 ] were greater in group L compared to group HE .
-RESULTS	In group L , the time to achieve maximal sensory block level ( MSBL ) was shorter ( 11.85.4 min versus 20.16.3 min , p < 0.0001 ) and MSBL was also higher than in group HE [ 14 ( T2 ) versus 12 ( T4 ) , p = 0.0015 ] .
-CONCLUSIONS	Head elevation during CSE and Caesarean section is superior to positioning without head elevation in the lateral to supine position , as it is associated with a more gradual onset , appropriate block height , and improved hemodynamics .
-
-###24771706
-BACKGROUND	Self-monitoring is reported to have limited efficacy for hypertension management in high-income countries .
-BACKGROUND	In this study , we aimed to evaluate the effect of self-monitoring on blood pressure ( BP ) control in an Iranian population .
-METHODS	A randomized controlled trial was conducted on 196 mild to moderate hypertensive patients in an outpatient cardiovascular clinic .
-METHODS	Patients in the intervention group received a wrist self-monitoring device and were educated to measure and document their BP daily during the study period ( 24 weeks ) .
-METHODS	Patients in the control group received usual care .
-METHODS	Three follow-up visits with the physician were scheduled for all patients ( weeks 4 , 12 , and 24 ) , and the investigator assessed adherence to medications after each visit ( pill counting ) .
-METHODS	The primary outcome ( BP ) was compared between groups using repeated-measure analysis of variance .
-RESULTS	One hundred ninety patients completed the study .
-RESULTS	Systolic BP ( 144.47.4 vs 145.96.4 mm Hg ) and diastolic BP ( 85.56.9 vs. 85.17.7 mm Hg ) were similar between groups at baseline .
-RESULTS	The trend of BP was not significantly different between groups during the study period .
-RESULTS	Systolic and diastolic BP decreased significantly in both groups at the first follow-up visit ( systolic BP : 132.6 vs. 133.4 mm Hg ; diastolic BP : 77.4 vs. 77.2 mm Hg ) .
-RESULTS	In the intervention group , we observed a small continued decrease in diastolic BP up to week 24 BP ( P = 0.01 ) .
-RESULTS	Both groups showed adherence rates > 95 % during the study period .
-CONCLUSIONS	Our study could not confirm that self-monitoring can improve BP control in patients with frequent medical visits .
-
-###24947928
-OBJECTIVE	To explore in a panel of patient-derived xenograft models of human non-small cell lung cancer ( NSCLC ) whether high EGFR expression , was associated with cetuximab activity .
-METHODS	NSCLC patient-derived xenograft models ( n = 45 ) were implanted subcutaneously into panels of nude mice and randomization cohorts were treated with either cetuximab , cisplatin , cisplatin plus cetuximab , vehicle control , or else were left untreated .
-METHODS	Responses according to treatment were assessed at week 3 by analyzing the relative change in tumor volume and an experimental analogue of the Response Evaluation Criteria in Solid Tumors ( RECIST ) guidelines .
-METHODS	An EGFR IHC score was calculated for each patient-derived xenograft model and response was assessed according to EGFR expression level .
-RESULTS	When tumors were stratified into high and low EGFR expression groups ( IHC score threshold 200 ; scale 0-300 ) , a stronger antitumor activity was seen in the high EGFR expression group compared with the low EGFR expression group in both the cetuximab monotherapy and cisplatin plus cetuximab combination therapy settings .
-RESULTS	For tumors treated with cisplatin plus cetuximab , the objective response rate was significantly higher in the high EGFR expression group compared with the low EGFR expression group ( 68 % vs. 29 % ) .
-RESULTS	Objective response rates were similar in high and low expression groups for tumors treated with cisplatin alone ( 27 % vs. 24 % , respectively ) .
-CONCLUSIONS	Cetuximab activity in NSCLC patient-derived xenograft models was demonstrated clearly only in tumors that expressed high levels of EGFR , as defined by an IHC score of 200 .
-
-###24923524
-BACKGROUND	Outcome measures of breast reconstruction have used panel assessment of photographs .
-BACKGROUND	This provides limited information to the assessor as these images are static .
-BACKGROUND	The aim of this study was to assess whether the use of digital video was a valid assessment tool and to compare its use against photography .
-METHODS	35 patients post-reconstruction underwent photography , digital video capture and completed Breast Cancer Treatment Outcomes Scale ( BCTOS ) questionnaires .
-METHODS	The photographs/video clips were randomised and shown to a 21 member panel .
-METHODS	Opinions on aesthetic aspects of the reconstruction were assessed using the BCTOS and Harris scale .
-METHODS	Panel inter-rater agreement and patient-panel correlation was assessed using Kendall 's Coefficient of Concordance and Spearman 's rank correlation tests respectively .
-RESULTS	There was a `` moderate '' degree of inter-rater agreement amongst panel members in all categories .
-RESULTS	Greater agreement occurred using video footage to assess overall cosmesis ( 0.548 vs 0.507 ) and shape ( 0.505 vs 0.486 ) .
-RESULTS	Video showed a greater degree of correlation with patient self-assessment scores in comparison to photography ( 0.311 vs 0.281 ) .
-CONCLUSIONS	Video footage coupled with panel assessment is a valid method of assessing post-operative outcomes of breast reconstruction and appears superior to still photographs in terms of inter-rater agreement and correlation with patient self-assessment .
-
-###24326981
-OBJECTIVE	This study was carried out to investigate the effect of vitamins E and C on cognitive performance among the elderly in Iran .
-METHODS	About 256 elderly with mild cognitive impairment , aged 60-75 years , received 300 mg of vitamin E plus 400 mg of vitamin C or placebo daily just for 1 year .
-BACKGROUND	Demographic characteristics , anthropometric variables food consumption , cognitive function by Mini-Mental State Examination ( MMSE ) , and some of the oxidative stress biomarkers were examined .
-RESULTS	Antioxidant supplementation reduced malondialdehyde level ( P < 0.001 ) and raised total antioxidant capacity ( P < 0.001 ) and glutathione ( P < 0.01 ) .
-RESULTS	The serum 8-hydroxydeoxyguanosine remained unchanged ( P < 0.4 ) .
-RESULTS	After adjusting for the covariates effects , MMSE scores following 6 - ( 25.88 0.17 ) and 12-month antioxidant supplementation ( 26.8 0.17 ) did not differ from control group ( 25.86 0.18 and 26.59 0.18 , respectively ) .
-CONCLUSIONS	Despite significant improvement in most of the oxidative stress biomarkers , antioxidants ' supplementation was not observed to enhance cognitive performance .
-CONCLUSIONS	A large number of kinetic and/or dynamic factors could be suspected .
-
-###25086478
-OBJECTIVE	Resorbable fixation material is an attractive option for those patients undergoing orthognathic surgery .
-OBJECTIVE	The efficacy of resorbable screws was tested in bilateral mandibular sagittal split osteotomies ( BSSOs ) performed for correction of retrognathic mandibles .
-METHODS	One hundred one patients were enrolled in this prospective randomized clinical trial .
-METHODS	Patients in group 1 ( n = 51 ) received titanium screws ( Stryker ) and patients in group 2 ( n = 50 ) received resorbable screws ( Inion CPS ) .
-METHODS	Outcome measurements were compared for statistical significance .
-RESULTS	There was a statistically significant difference in the use of postoperative elastics ( P < .0001 ) .
-RESULTS	There was no statistically significant difference in other outcome measurements , including clinical evidence of relapse .
-CONCLUSIONS	Resorbable screws can be used effectively for fixation of BSSO for mandibular advancement .
-CONCLUSIONS	A higher incidence of rotation around positional screws can result secondary to the mechanical `` looseness '' when using resorbable screws .
-CONCLUSIONS	This can be treated effectively using Class III mechanic elastics during the initial stages of bone healing .
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-###25005339
-OBJECTIVE	We sought to determine whether exclusion of infection and antibiotic stewardship with the infection biomarker procalcitonin improves outcomes in congestive heart failure ( CHF ) patients presenting to emergency departments with respiratory symptoms and suspicion of respiratory infection .
-METHODS	We performed a secondary analysis of patients with a past medical history of CHF formerly included in a Swiss multicenter randomized-controlled trial .
-METHODS	The trial compared antibiotic stewardship according to a procalcitonin algorithm or state-of-the-art guidelines ( controls ) .
-METHODS	The primary endpoint was a 30-day adverse outcome ( death , intensive care unit admission ) ; the secondary endpoints included a 30-day antibiotic exposure .
-RESULTS	In the 110/233 analyzed patients ( 47.2 % ) with low initial procalcitonin ( < 0.25 g/L ) , suggesting the absence of systemic bacterial infection , those randomized to procalcitonin guidance ( n = 50 ) had a significantly lower adverse outcome rate compared to controls ( n = 60 ) : 4 % vs. 20 % ( absolute difference -16.0 % , 95 % confidence interval ( CI ) -28.4 % to -3.6 % , P = 0.01 ) , and significantly reduced antibiotic exposure [ days ] ( mean 3.7 4.0 vs. 6.5 4.4 , difference -2.8 [ 95 % CI , -4.4 to -1.2 ] , P < 0.01 ) .
-RESULTS	When initial procalcitonin was 0.25 g/L , procalcitonin-guided patients had significantly reduced antibiotic exposure due to early stop of therapy without any difference in adverse outcomes ( 25.8 % vs. 24.6 % , difference [ 95 % CI ] 1.2 % [ -14.5 % to 16.9 % , P = 0.88 ] ) .
-CONCLUSIONS	CHF patients presenting to the emergency department with respiratory symptoms and suspicion for respiratory infection had decreased antibiotic exposure and improved outcomes when procalcitonin measurement was used to exclude bacterial infection and guide antibiotic treatment .
-CONCLUSIONS	These data provide further evidence for the potential harmful effects of antibiotic / fluid treatment when used instead of diuretics and heart failure medication in clinically symptomatic CHF patients without underlying infection .
-
-###24436138
-BACKGROUND	Children surviving acute lymphoblastic leukemia ( ALL ) are at increased risk for overweight and obesity over that of the general population .
-BACKGROUND	Whether a generic or tailored approach to weight management is needed for cancer survivors has yet to be tested .
-METHODS	Thirty-eight youth 8-18 years with BMI 85 % who had survived ALL were recruited for a randomized clinical trial evaluating a weight management intervention ( WMI ) tailored for childhood ALL survivors ( Fit4Life ) .
-METHODS	Fit4Life recipients received a 4-month web , phone , and text message-delivered WMI tailored for cancer survivorship .
-METHODS	Controls received a general WMI delivered via phone and mail .
-METHODS	Assessments were performed at baseline and 4 months .
-METHODS	Outcome data were analyzed according to assigned treatment condition over time .
-RESULTS	Most ( 80 % , ( 70 % , 100 % ) [ median ( IQR ) ] ) of the assigned curriculum was received by Fit4Life participants as compared to 50 % ( 40 % , 65 % ) among controls .
-RESULTS	Fit4Life recipients 14 years demonstrated less weight gain ( P = 0.05 ) and increased moderate-to-vigorous physical activity ( P < 0.01 ) while all Fit4Life recipients reported reduced negative mood ( P < 0.05 ) over time as compared to control counterparts .
-CONCLUSIONS	We demonstrated acceptable feasibility of a WMI tailored for overweight and obese children surviving ALL utilizing a multimodal technology approach .
-CONCLUSIONS	Improved weight , weight-related behavior , and psychological outcomes were demonstrated among Fit4Life intervention as compared to youth receiving a generic WMI .
-CONCLUSIONS	Data from this pilot trial may be used to design a larger trial to determine whether youth of all ages also can derive a benefit from a cancer survivor-tailored WMI and whether short-term outcomes translate into improved long-term outcomes for childhood ALL survivors .
-
-###24404819
-OBJECTIVE	Patient self-management support may be augmented by using home-based technologies that generate data points that providers can potentially use to make more timely changes in the patients ' care .
-OBJECTIVE	The purpose of this study was to evaluate the effectiveness of short-term targeted use of remote data transmission on treatment outcomes in patients with diabetes who had either out-of-range hemoglobin A1c ( A1c ) and/or blood pressure ( BP ) measurements .
-METHODS	A single-center randomized controlled clinical trial design compared in-home monitoring ( n = 55 ) and usual care ( n = 53 ) in patients with type 2 diabetes and hypertension being treated in primary care clinics .
-METHODS	Primary outcomes were A1c and systolic BP after a 12-week intervention .
-RESULTS	There were no significant differences between the intervention and control groups on either A1c or systolic BP following the intervention .
-CONCLUSIONS	The addition of technology alone is unlikely to lead to improvements in outcomes .
-CONCLUSIONS	Practices need to be selective in their use of telemonitoring with patients , limiting it to patients who have motivation or a significant change in care , such as starting insulin .
-CONCLUSIONS	Attention to the need for effective and responsive clinic processes to optimize the use of the additional data is also important when implementing these types of technology .
-
-###25096315
-BACKGROUND	It is empirically well documented that psychotherapy is vital in the treatment of chronic back pain .
-OBJECTIVE	To test in this randomized controlled clinical trial whether cognitive behavior group therapy is effective in respect to pain tolerance and disability apart from the effects on somatization in general and additional to the effects of a multimodal inpatient orthopedic rehabilitation programme .
-METHODS	Fifty-three patients were randomly assigned to an intervention group , receiving six sessions of `` cognitive behavior group therapy for back pain '' ( CBT-BP ) , and 50 to a control group who got unspecific occupational therapy sessions instead .
-METHODS	Patients were suffering from chronic back pain for at least six months .
-METHODS	All patients were treated for 21 days in an orthopedic inpatient rehabilitation unit with a multimodal orthopedic treatment , including active physical therapy , patient education or motivation to exercise .
-RESULTS	In both groups there is a significant improvement over time in the Symptom Checklist ( SCL-90 ) , the Rating of Health Locus of Control Attributions , the Fear Avoidance Beliefs Questionnaire ( FABQS ) and a Visual Analogue Pain Scale ( VAS-pain ) .
-RESULTS	There are significant interactions between treatment group and VAS-pain and the FABQS , showing a superior improvement in the intervention group , while no significant superiority is found for the SCL .
-CONCLUSIONS	The experience of pain can be altered directly and not only through improvement of depression or general somatoform complaints .
-CONCLUSIONS	The study replicates other research and increases the evidence base for this mode of treatment .
-CONCLUSIONS	The treatment effect can be called specific as it is found additional to a multimodal inpatient care programme .
-
-###25682177
-OBJECTIVE	To investigate whether the 2-year change in lens opacity severity on the Age-Related Eye Disease Study ( AREDS ) lens grading scale predicts progression to cataract surgery or loss of visual acuity by 5 years .
-METHODS	Prospective cohort study within a randomized clinical trial of oral supplements .
-METHODS	The AREDS participants whose eyes were phakic at baseline and free of late age-related macular degeneration throughout the study .
-METHODS	Baseline and annual lens photographs of AREDS participants ( n = 3466/4757 ; 73 % ) were graded for severity of cataracts using the AREDS system for classifying cataracts from photographs .
-METHODS	Clinical examinations conducted semiannually collected data on cataract surgery and visual acuity .
-METHODS	Association of the change in lens opacities at 2 years with these outcomes at 5 years was analyzed with adjusted Cox proportional hazard models .
-METHODS	Progression of lens opacities on stereoscopic lens photographs at 2 years , cataract surgery , and visual acuity loss of 2 lines or more at 5 years .
-RESULTS	The adjusted hazard ratios ( HRs ) for association of progression to cataract surgery at 5 years were : nuclear cataract increase of 1.0 unit or more compared with less than 1.0-unit change at 2 years , 2.77 ( 95 % confidence interval [ CI ] , 2.07-3 .70 ; P < 0.001 ) ; cortical cataract increase of 5 % or more in lens opacity in the central 5 mm of the lens compared with less than 5 % increase at 2 years , 1.91 ( 95 % CI , 1.27-2 .87 ; P = 0.002 ) ; and posterior subcapsular cataract increase of 5 % or more versus less than 5 % in the central 5 mm of the lens , 8.25 ( 95 % CI , 5.55-12 .29 ; P < 0.001 ) .
-RESULTS	Similarly , HRs of vision loss of 2 lines or more at 5 years for this degree of lens changes at 2 years were the following : nuclear , 1.83 ( 95 % CI , 1.49-2 .25 ; P < 0.001 ) ; cortical , 1.13 ( 95 % CI , 0.78-1 .65 ; P = 0.519 ) ; and posterior subcapsular cataract , 3.05 ( 95 % CI , 1.79-5 .19 ; P < 0.001 ) .
-CONCLUSIONS	Two-year changes in severity of lens opacities on the AREDS lens grading scale are predictive of long-term clinically relevant outcomes , making them potential surrogate end points in follow-up studies .
-
-###25548744
-OBJECTIVE	Angiotensin receptor blockers ( ARBs ) inhibit activated hepatic stellate cell contraction and are thought to reduce the dynamic portion of intrahepatic resistance .
-OBJECTIVE	This study compared the effects of combined treatment using the ARB candesartan and propranolol versus propranolol monotherapy on portal pressure in patients with cirrhosis in a prospective , randomized controlled trial .
-METHODS	Between January 2008 and July 2009 , 53 cirrhotic patients with clinically significant portal hypertension were randomized to receive either candesartan and propranolol combination therapy ( 26 patients ) or propranolol monotherapy ( 27 patients ) .
-METHODS	Before and 3 months after the administration of the planned medication , the hepatic venous pressure gradient ( HVPG ) was assessed in both groups .
-METHODS	The dose of propranolol was subsequently increased from 20 mg bid until the target heart rate was reached , and the candesartan dose was fixed at 8 mg qd .
-METHODS	The primary endpoint was the HVPG response rate ; patients with an HVPG reduction of > 20 % of the baseline value or to < 12 mmHg were defined as responders .
-RESULTS	The mean portal pressure declined significantly in both groups , from 16 mmHg ( range , 12-28 mmHg ) to 13.5 mmHg ( range , 6-20 mmHg ) in the combination group ( P < 0.05 ) , and from 17 mmHg ( range , 12-27 mmHg ) to 14 mmHg ( range , 7-25 mmHg ) in the propranolol monotherapy group ( P < 0.05 ) .
-RESULTS	However , the medication-induced pressure reduction did not differ significantly between the two groups [ 3.5 mmHg ( range , -3 -11 mmHg ) vs. 3 mmHg ( range , -8 -10 mmHg ) , P = 0.674 ] .
-RESULTS	The response rate ( 55.6 % vs. 61.5 % , P = 0.435 ) and the reductions in mean blood pressure or heart rate also did not differ significantly between the combination and monotherapy groups .
-CONCLUSIONS	The addition of candesartan ( an ARB ) to propranolol confers no benefit relative to classical propranolol monotherapy for the treatment of portal hypertension , and is thus not recommended .
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-###24758169
-BACKGROUND	Repeat infection with Chlamydia trachomatis is common and increases the risk of sequelae in women and HIV seroconversion in men who have sex with men ( MSM ) .
-BACKGROUND	Despite guidelines recommending chlamydia retesting three months after treatment , retesting rates are low .
-BACKGROUND	We are conducting the first randomised controlled trial to assess the effectiveness of home collection combined with short message service ( SMS ) reminders on chlamydia retesting and reinfection rates in three risk groups .
-METHODS	The REACT ( retest after Chlamydia trachomatis ) trial involves 600 patients diagnosed with chlamydia : 200 MSM , 200 women and 200 heterosexual men recruited from two Australian sexual health clinics where SMS reminders for retesting are routine practice .
-METHODS	Participants will be randomised to the home group ( 3-month SMS reminder and home-collection ) or the clinic group ( 3-month SMS reminder to return to the clinic ) .
-METHODS	Participants in the home group will be given the choice of attending the clinic if they prefer .
-METHODS	The mailed home-collection kit includes a self-collected vaginal swab ( women ) , UriSWAB ( Copan ) for urine collection ( heterosexual men ) , and UriSWAB plus rectal swab ( MSM ) .
-METHODS	The primary outcome is the retest rate at 1-4 months after a chlamydia diagnosis , and the secondary outcomes are : the repeat positive test rate ; the reinfection rate ; the acceptability of home testing with SMS reminders ; and the cost effectiveness of home testing .
-METHODS	Sexual behaviour data collected via an online survey at 4-5 months , and genotyping of repeat infections , will be used to discriminate reinfections from treatment failures .
-METHODS	The trial will be conducted over two years .
-METHODS	An intention to treat analysis will be conducted .
-CONCLUSIONS	This study will provide evidence about the effectiveness of home-collection combined with SMS reminders on chlamydia retesting , repeat infection and reinfection rates in three risk groups .
-CONCLUSIONS	The trial will determine client acceptability and cost effectiveness of this strategy .
-BACKGROUND	Australian and New Zealand Clinical Trials Registry ACTRN12611000968976 .
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-###25044909
-METHODS	Blueberries are a rich source of flavonoids and phenolic acids .
-METHODS	Currently , little information is available regarding the impact of processing on the bioavailability and the bioactivity of blueberry ( poly ) phenols .
-RESULTS	In a randomized , controlled crossover trial , ten healthy volunteers consumed ( a ) blueberry-containing baked products , ( b ) an unprocessed blueberry drink containing the same amount of freeze-dried blueberry powder as used in the baked products , and ( c ) matched control baked products .
-RESULTS	Endothelial function was measured as flow-mediated dilation ( FMD ) and plasma samples taken at baseline and at 1 , 2 , 4 , and 6 h postconsumption .
-RESULTS	Although processing did not significantly change the total ( poly ) phenolic amount , the processed products contained significantly less anthocyanins ( -42 % ) , more chlorogenic acid ( 23 % ) , no flavanol nonamers or decamers , and significantly more flavanol dimers and trimers ( 36 % and 28 % , respectively ) .
-RESULTS	FMD increased after 1 , 2 , and 6 h consumption of the baked products to a similar degree as the unprocessed blueberries , despite significant differences in the levels of individual plasma metabolites .
-RESULTS	No changes were observed after the consumption of the control product .
-CONCLUSIONS	Careful processing can preserve important biological activities of blueberries despite changing the blueberry ( poly ) phenol composition and plasma metabolite profile .
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-###25171664
-OBJECTIVE	The aim of this study was to investigate safety , tolerance , relative exercise intensity , and muscle substrate oxidation during sessions performed on a Huber Motion Lab in coronary heart disease patients .
-METHODS	After an assessment of Vo2 peak , 20 coronary heart disease patients participated in two different exercises performed in random order at 40 % and 70 % ( W40 and W70 ) of the maximal isometric voluntary contraction .
-RESULTS	No significant arrhythmia or abnormal blood pressure responses occurred during either session , and no muscle soreness was reported within 48 hrs posttest .
-RESULTS	The authors found a difference between W40 and W70 sessions for mean ( standard deviation ) ventilation ( 25.1 % [ 8 % ] and 32.1 % [ 9 % ] of maximal ventilation , respectively ; P = 0.04 ) and a small difference for mean ( standard deviation ) heart rate ( 73 [ 7 ] and 79 [ 8 ] beats/min , respectively ; P < 0.01 ) .
-RESULTS	When compared with the W40 , the W70 was associated with higher active energy expenditure ( 2.4 [ 0.6 ] and 3.1 [ 0.9 ] Kcal/min , respectively ; P < 0.0001 ) and a similar mean ( standard deviation ) oxygen uptake ( 5.5 [ 1 ] and 6.6 [ 1 ] ml/min per kilogram , respectively ; P = 0.07 ) .
-RESULTS	The qualitative percentages of carbohydrates and lipids oxidized were 71 % and 29 % , respectively , at W40 and 91 % and 9 % , respectively , at W70 .
-CONCLUSIONS	Both protocols , which consisted of repeating 6-sec phases of contractions with 10 secs of passive recovery on the Huber Motion Lab , seemed to be well tolerated , safe , and feasible in this group of coronary heart disease patients .
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-###26054135
-OBJECTIVE	To observe the impacts on endometrial and pregnancy outcomes treated with acupuncture and moxibustion in the patients of in vitro fertilization-embryo transfer ( IVF-ET ) and explore the application value , of acupuncture and moxibustion in IVF-ET treatment .
-METHODS	One hundred and fourteen patients of IVF-ET treated with standard long-term program at luteal phase were randomized into an observation group and a control group , 57 cases in each one .
-METHODS	In the observation group , at the beginning of ovulatory induction , moxibustion was applied to Shenque ( CV 8 ) and acupuncture was to Zhongji ( CV 3 ) , Guanyuan ( CV 4 ) , Qihai ( CV 6 ) , Zigong ( EX-CA 1 ) , Xuebai ( SP 10 ) , etc. till the transfer time for one session of treatment .
-METHODS	Totally , 3 sessions were required .
-METHODS	In the control group , no intervention of acupuncture and moxibustion was applied .
-METHODS	The endometrial morphology , subendometrial blood flow index , the levels of serum estradiol ( E2 ) , progesterone ( P ) and luteinizing hormone ( LH ) on the day of injection of human chorionic gonadotropin ( hCG ) , the dosage and time of gonadotropin ( Gn ) , oocyte count , high-quality embryo number , embryo cultivation rate and clinical pregnant rate were observed in the two groups .
-RESULTS	The A type endometrial proportion on hCG day and high-quality embryo rate in the observation group were higher than those in the control group , indicating the significant differences ( both P < 0.05 ) .
-RESULTS	The difference in endometrial thickness on hCG day was not significant between the two groups ( P > 0.05 ) .
-RESULTS	In the observation group , endometrial hemodynamic index ( peak systolic blood velocity/end-diastolic blood velocity , S/D ) , resistive index ( RI ) and pulse index ( PI ) were lower than those in the control group ( P < 0.01 , P < 0.05 ) .
-RESULTS	The levels of serum E2 and P on hCG day in the observation group were higher than those in the control group ( both P < 0.05 ) .
-RESULTS	The differences were not significant in Gn dose , Gn medication time , numbers of follicles > 1.6 cm on hCG day , oocyte count , embryo cultivation rate and clinical pregnancy rate and LH level on hCG day between the two groups ( all P > 0.05 ) .
-CONCLUSIONS	In IVF-ET treatment , acupuncture and moxibustion affect estrogen level on hCG day , improve high-quality embryo rate , endometrial blood flow state and morphology so that the endometrial receptivity is increased and the method is expected to be the assistant therapeutic approach for the improvement of IVF-ET outcome .
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-###25131413
-OBJECTIVE	The pilot study purpose was to determine the effects of a new standardized oral care protocol ( intervention ) to usual care practices ( control ) in poststroke patients .
-METHODS	This study is a randomized controlled clinical trial .
-METHODS	Fifty-one subjects were enrolled .
-METHODS	Subjects in the intervention group received oral care twice a day including tooth brushing , tongue brushing , flossing , mouth rinse , and lip care while control patients received usual oral care .
-RESULTS	Subjects in the control and intervention groups showed improvement in their oral health assessments , swallowing abilities and oral intake .
-RESULTS	There were no significant differences between the two groups .
-RESULTS	Although not statistically significant , overall prevalence of methicillin-resistant Staphylococcus aureus and methicillin-sensitive Staphylococcus aureus colonization in the control group almost doubled ( from 4.8 % to 9.5 % ) , while colonization in the intervention group decreased ( from 20.8 % to 16.7 % ) .
-CONCLUSIONS	These findings demonstrate the importance of oral care in the poststroke patient with dysphagia .
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-###24799001
-OBJECTIVE	The current study assessed relations among maternal depressive symptoms , poorer youth diabetes adherence , and glycemic control .
-OBJECTIVE	Specifically , hypothesized mediating links of lowered expectations of parental involvement , less parental monitoring , and more conflict were examined .
-METHODS	Participants included 225 mothers and their young adolescents , aged 11-14 years ( M = 12.73 years , SD = 1.2 ) diagnosed with T1D .
-METHODS	Maternal depressive symptoms and outcome expectancies for maternal involvement were evaluated with self-report questionnaires .
-METHODS	Multisource , parent/youth , and multimethod assessment of adherence , parental monitoring , and conflict were evaluated during a baseline assessment from a larger randomized clinical trial .
-RESULTS	The first hypothesized structural equation model demonstrated a good fit and indicated that more maternal depressive symptoms were directly associated with less parental monitoring and more conflict , which in turn each were associated with poorer adherence and glycemic control .
-RESULTS	Although higher involvement expectancies were associated with more monitoring and less conflict , they were not associated with other model variables .
-RESULTS	A second alternative model also fit the data well ; poorer youth adherence was associated with more conflict that in turn related to maternal depressive symptoms .
-CONCLUSIONS	Two models were tested by which maternal depressive symptoms and poorer youth adherence were interrelated via less monitoring and more conflict .
-CONCLUSIONS	Follow-up longitudinal evaluation can best characterize the full extent of these relations .
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-###24285458
-OBJECTIVE	To evaluate the effectiveness of specialized physiotherapy methods measured by the BODE index in patients with COPD during hospitalization .
-METHODS	The study was conducted on a group of 30 patients diagnosed with COPD , all under treatment at the clinical hospital in Wroclaw due to the exacerbation of their symptoms .
-METHODS	All patients were undergoing standard pharmacological treatment along with basic physiotherapy .
-METHODS	The subjects of the study were randomly divided between an experimental group of 20 persons and a control group of 10 persons .
-METHODS	Patients in the experimental group underwent a series of 6 additional massage treatments performed over a period of a few days , aimed at reshaping the following muscles : the sterno-cleidomastoid , pectoralis major , pectoralis minor , trapezius , levator scapulae , rhomboids and serratus anterior .
-METHODS	Each massage lasted for 30 minutes and consisted of stroking , grinding , vibration and kneading techniques .
-METHODS	Before and after therapy the patients were assessed based on the BODE index .
-METHODS	First , the patient 's BMI was calculated ( B ) .
-METHODS	Airflow obstruction ( O ) was determined by the percentage value of FEV1 while the MRC scale was used to evaluate a patient 's dyspnea ( D ) .
-METHODS	Exercise capacity ( E ) was measured by the distance a patient could cover in a 6-minute walk test .
-METHODS	Each variable of the BODE index was ranked on a scale from 0 to 3 points except the BMI , for which was given either 0 or 1 point .
-RESULTS	Analysis of the results showed a significant improvement of the BODE index in the experimental group while in the control group this ratio changed slightly .
-RESULTS	The FEV1 and MRC parameters changed significantly only in the experimental group .
-CONCLUSIONS	After a week of therapy the BODE index improved in both groups , but in the experimental group there was a significantly higher difference .
-CONCLUSIONS	In the experimental group all BODE components except BMI improved highly significantly , whereas in the control group only exercise capacity was significantly improved .
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-###24756534
-OBJECTIVE	The gold standard in ACL reconstructions has been the bone-patellar tendon-bone autograft fixed with interference screws .
-OBJECTIVE	This prospective , randomized clinical trial aimed to compare two methods of fixation for BPTB grafts : press-fit fixation vs. interference screw , over a 12-month follow-up interval .
-METHODS	158 patients with an average age of 29.8 years , between 2011 and 2012 , were treated for torn ACL .
-METHODS	82 patients underwent reconstruction with BPTB autograft with a press fit fixation technique , and in 76 cases an interference screw was used .
-METHODS	At the time of final follow-up , 71 patients in press-fit group and 65 patients in interference screw group were evaluated in terms of return to pre-injury activity level , pain , knee stability , range of motion , IKDC score and complications .
-RESULTS	At 12-month follow-up , 59 ( 83 % ) and 55 ( 85 % ) in press-fit and screw group , respectively had good-to-excellent IKDC score ( p > 0.05 ) .
-RESULTS	The mean laxity assessed using a KT-1000 arthrometer improved to 2.7 and 2.5 mm in press-fit and screw group , respectively .
-RESULTS	Regarding Lachman and pivot shift test , there was a statistically significant improvement in the integrity of the ACL in both the groups , but no significant differences was noted between groups .
-RESULTS	There were no significant differences in terms of femur circumference difference , effusion , knee range of motion , pain and complications .
-CONCLUSIONS	The press-fit technique is an efficient procedure .
-CONCLUSIONS	Its outcome was comparable with the interference screw group .
-CONCLUSIONS	Furthermore it has unlimited bone-to-bone healing , no need for removal of hardware , ease for revision and cost effectiveness .
-
-###24998674
-BACKGROUND	When used with standard diagnostic testing , point-of-care ultrasonography might improve the proportion of patients admitted with respiratory symptoms who are correctly diagnosed 4 h after admission to the emergency department .
-BACKGROUND	We therefore assessed point-of-care ultrasonography of the heart , lungs , and deep veins in addition to the usual initial diagnostic testing in this patient population .
-METHODS	In a prospective , parallel-group trial in the emergency department at Odense University Hospital , Odense , Denmark , patients ( 18 years ) with a respiratory rate of more than 20 per min , oxygen saturation of less than 95 % , oxygen therapy , dyspnoea , cough , or chest pain were randomly assigned in a 1:1 ratio with a computer-generated list to a standard diagnostic strategy ( control group ) or to standard diagnostic tests supplemented with point-of-care ultrasonography of the heart , lungs , and deep veins ( point-of-care ultrasonography group ) .
-METHODS	The primary endpoint was the percentage of patients with a correct presumptive diagnosis 4 h after admission to the emergency department .
-METHODS	Only the physicians doing the primary clinical assessment and the auditors were masked .
-METHODS	Analyses were by intention to treat .
-METHODS	The study is registered with ClinicalTrials.gov , number NCT01486394 .
-RESULTS	Between Dec 7 , 2011 , and March 15 , 2013 , 320 patients were randomly assigned to the control group ( n = 160 ) and point-of-care ultrasonography group ( n = 160 ) .
-RESULTS	158 patients in the point-of-care ultrasonography group and 157 in the control group were analysed .
-RESULTS	4 h after admission to the emergency department , 139 patients ( 880 % ; 95 % CI 828-931 ) in the point-of-care ultrasonography group versus 100 ( 637 % ; 561-713 ) in the control group had correct presumptive diagnoses ( p < 00001 ) .
-RESULTS	The absolute and relative effects were 243 % ( 95 % CI 150-331 ) and 138 ( 101-131 ) , respectively .
-RESULTS	No adverse events were reported .
-CONCLUSIONS	Point-of-care ultrasonography is a feasible , radiation free , diagnostic test , which alongside standard diagnostic tests is superior to standard diagnostic tests alone for establishing a correct diagnosis within 4 h.
-CONCLUSIONS	It should therefore be considered for routine use as part of the standard diagnostic tests in the emergency department for patients admitted with respiratory symptoms .
-BACKGROUND	University of Southern Denmark , Odense University Hospital , and Hjbjerg Fund .
-
-###24611923
-OBJECTIVE	The purpose of the current study is to examine the efficacy of Counselor-Assisted Problem Solving ( CAPS ) in improving caregiver adaptation following traumatic brain injury ( TBI ) .
-METHODS	In a randomized clinical trial comparing CAPS ( n = 65 ) , an online problem-solving intervention with accompanying Web-based counseling sessions , with an information-based Internet Resource Comparison ( IRC ; n = 67 ) program , participants included families of 12 - to 17-year-olds who had sustained a TBI in the past 6 months .
-METHODS	Linear regression analyses were used to identify main effects and to examine whether caregiver education , race , or prior computer use moderated treatment efficacy .
-RESULTS	Computer experience moderated postintervention improvements in caregiving self-efficacy following CAPS , Specifically , parents in CAPS with low levels of prior use reporting the greatest improvements .
-RESULTS	CAPS participants who completed 5 or more sessions reported greater reductions in depression than did the IRC ; however , the groups did not differ on global distress .
-CONCLUSIONS	Findings support the potential utility of counselor-supported Web-based interventions particularly for individuals with limited computer expertise following adolescent TBI .
-
-###25715664
-OBJECTIVE	Digital plain radiographs of the pelvis are frequently performed in follow-up examinations of patients who received total hip arthroplasty ( THA ) or osteosynthesis ( OS ) .
-OBJECTIVE	Thus , the purpose was to reduce the radiation dose and to determine objective quality control criteria to ensure accurate assessment .
-METHODS	Institutional review board approval was obtained .
-METHODS	In this prospective randomized study , 289 patients underwent X-ray examination of the pelvis as follow up after receiving THA or OS with standard and reduced dose .
-METHODS	The evaluation of the plain radiographs was conducted using the following criteria : bone-implant interface , implant-implant discrimination , implant-surface character and periarticular heterotopic ossification .
-METHODS	Two radiologists evaluated these criteria using a score ranging from 1 ( definitely assessable ) to 4 ( not assessable ) .
-METHODS	If a single criterion had been evaluated with a score of 3 or more or more than 2 criteria with 2 points , the radiograph was scored as `` not assessable '' .
-METHODS	The study was designed as non-inferiority-trial .
-RESULTS	Seven ( 2.4 % ) examined X-rays were scored as not assessable .
-RESULTS	There was no statistical inferiority between the examinations with standard ( 0.365 mSv ) or reduced dose ( 0.211 mSv ) .
-RESULTS	Reduced dose only led to limitations in the evaluation of ceramic components with low clinical impact in most scenarios .
-CONCLUSIONS	Plain radiography of the pelvis in patients with THA or OS can be performed with a dose reduction of about 42 % without a loss of important information .
-CONCLUSIONS	The obtained quality control criteria were clinically applicable .
-
-###24714184
-BACKGROUND	We developed a tailored education program using a touch-screen computer for changing management behavior with asthmatic children and their caregivers .
-BACKGROUND	The purpose of this study was to examine the effect of the tailored education program .
-METHODS	Caregivers including children with asthma were recruited during visits to a national children 's hospital and those whose month-long asthma condition on the JPAC ( Japanese Pediatric Asthma Program ) score was 14 and below were included .
-METHODS	Caregivers were randomized to the tailored education ( intervention group ) or non-tailored education ( control group ) .
-METHODS	The intervention group underwent a patient education program using a touch-screen computer , and they received tailored messages generated by a computer program .
-METHODS	A research nurse and clinical psychologist used a computer-based resource to tailor the education messages and provided counseling using motivational interviewing for the caregivers including children with asthma .
-METHODS	The control group received only a booklet on asthma .
-RESULTS	Forty-seven subjects aged 1 to 6 years were enrolled .
-RESULTS	Forty-seven caregivers were randomized to the tailored education ( n = 22 ) or non-tailored education ( n = 25 ) group .
-RESULTS	The results of two-way ANOVA showed that interactions between groups were observed in the score of JPAC and asthma knowledge for preschool children whose asthma onset was within one year and a half .
-RESULTS	The main effects of time were observed in the total and subscale score of QOL ( Quality of Life ) and the total score of P-CASES ( Parental Childhood Asthma 's Self-efficacy Scale ) .
-CONCLUSIONS	These findings indicate the benefit of a tailored education program to control symptoms in such caregivers .
-
-###24684390
-OBJECTIVE	( R , S ) - ketamine produces rapid and significant antidepressant effects in approximately 65 % of patients suffering from treatment-resistant bipolar depression ( BD ) .
-OBJECTIVE	The genetic , pharmacological and biochemical differences between ketamine responders and non-responders have not been identified .
-OBJECTIVE	The purpose of this study was to employ a metabolomics approach , a global , non-targeted determination of endogenous metabolic patterns , to identify potential markers of ketamine response and non-response .
-METHODS	Plasma samples from 22 BD patients were analyzed to produce metabolomic patterns .
-METHODS	The patients had received ketamine in a placebo-controlled crossover study and the samples were obtained 230min post-administration at which time the patients were categorized as responders or non-responders .
-METHODS	Matching plasma samples from the placebo arm of the study were also analysed .
-METHODS	During the study , the patients were maintained on either lithium or valproate .
-RESULTS	The metabolomic patterns were significantly different between the patients maintained on lithium and those maintained on valproate , irrespective of response to ketamine .
-RESULTS	In the patients maintained on lithium , 18 biomarkers were identified .
-RESULTS	In responders , lysophosphatidylethanolamines ( 4 ) and lysophosphatidylcholines ( 9 ) were increased relative to non-responders .
-CONCLUSIONS	The results indicate that the differences between patients who respond to ketamine and those who do not are due to alterations in the mitochondrial - oxidation of fatty acids .
-CONCLUSIONS	These differences were not produced by ketamine administration .
-CONCLUSIONS	The data indicate that pretreatment metabolomics screening may be a guide to the prediction of response and a potential approach to the individualization of ketamine therapy .
-
-###24899268
-OBJECTIVE	Many questions remain unanswered about the role of bariatric surgery for people with type 2 diabetes mellitus ( T2DM ) .
-OBJECTIVE	To determine feasibility of a randomized clinical trial ( RCT ) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating T2DM in participants with grades I and II obesity .
-METHODS	A 12-month , 3-arm RCT at a single center including 69 participants aged 25 to 55 years with a body mass index ( calculated as weight in kilograms divided by height in meters squared ) of 30 to 40 and T2DM .
-METHODS	Roux-en-Y gastric bypass ( RYGB ) , laparoscopic adjustable gastric banding ( LAGB ) , and an intensive lifestyle weight loss intervention ( LWLI ) .
-METHODS	Primary outcomes in the intention-to-treat cohort were feasibility and effectiveness measured by weight loss and improvements in glycemic control .
-RESULTS	Of 667 potential participants who underwent screening , 69 ( 10.3 % ) were randomized .
-RESULTS	Among the randomized participants , 30 ( 43 % ) had grade I obesity , and 56 ( 81 % ) were women .
-RESULTS	Mean ( SD ) age was 47.3 ( 6.4 ) years and hemoglobin A1c level , 7.9 % ( 2.0 % ) .
-RESULTS	After randomization , 7 participants ( 10 % ) refused to undergo their allocated intervention ( 3 RYGB , 1 LAGB , and 3 LWLI ) , and 1 RYGB participant was excluded for current smoking .
-RESULTS	Twenty participants underwent RYGB ; 21 , LAGB ; and 20 , LWLI , with 12-month retention rates of 90 % , 86 % , and 70 % , respectively .
-RESULTS	In the intention-to-treat cohort with multiple imputation for missing data , RYGB participants had the greatest mean weight loss from baseline ( 27.0 % ; 95 % CI , 30.8-23 .3 ) compared with LAGB ( 17.3 % ; 95 % CI , 21.1-13 .5 ) and LWLI ( 10.2 % ; 95 % CI , 14.8-5 .61 ) ( P < .001 ) .
-RESULTS	Partial and complete remission of T2DM were 50 % and 17 % , respectively , in the RYGB group and 27 % and 23 % , respectively , in the LAGB group ( P < .001 and P = .047 between groups for partial and complete remission ) , with no remission in the LWLI group .
-RESULTS	Significant reductions in use of antidiabetics occurred in both surgical groups .
-RESULTS	No deaths were noted .
-RESULTS	The 3 serious adverse events included 1 ulcer treated medically in the RYGB group and 2 rehospitalizations for dehydration in the LAGB group .
-CONCLUSIONS	This study highlights several potential challenges to successful completion of a larger RCT for treatment of T2DM and obesity in patients with a body mass index of 30 to 40 , including the difficulties associated with recruiting and randomizing patients to surgical vs nonsurgical interventions .
-CONCLUSIONS	Preliminary results show that RYGB was the most effective treatment , followed by LAGB for weight loss and T2DM outcomes at 1 year .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01047735 .
-
-###24225780
-OBJECTIVE	: Periimplantitis is a bacterial complication after dental implants implantation .
-OBJECTIVE	Photodynamic therapy ( PDT ) implies the use of low-power laser in combination with appropriate photosensitizer to increase the detoxification of the implant surfaces .
-OBJECTIVE	Little information exists about PDT in the treatment of periimplantitis .
-OBJECTIVE	A randomized comparative case-control study has been conducted with 20 patients and 20 controls to compare the efficacy of antimicrobial PDT versus surgical therapy in patients with periimplantitis , who have received dental implants with rough surfaces .
-METHODS	In the surgery group , mucoperiosteal flap surgery was used with scaling on implant surfaces and debridement of granulation tissue .
-METHODS	Microbiologic testing was evaluated before and after intervention treatment , at 12 and 24 weeks in the study subjects .
-CONCLUSIONS	Total anaerobic counts of bacteria did not differ significantly between patients assigned to receive PDT and those assigned to receive surgical therapy ( mean , 95.2 % and 80.85 % , respectively ) .
-CONCLUSIONS	PDT was associated with a significant decrease in bleeding scores ( P = 0.02 ) as well as inflammatory exudation ( P = 0.001 ) .
-CONCLUSIONS	Treatment with PDT in patients with periimplantitis was not associated with major reduction of total anaerobic bacteria on the rough surfaces of dental implants as compared with surgical therapy .
-CONCLUSIONS	A significantly lower proinflammatory index of periimplantitis was observed in the PDT group at 24 weeks of follow-up .
-
-###24934642
-BACKGROUND	In multicomponent interventions it is important to examine the implementation of each component to enable valid assessments of the effectiveness of each component .
-BACKGROUND	Many studies do not systematically document , evaluate and report the level of implementation and there is a lack of systematic approaches to conduct process evaluation studies to guide researchers and evaluators .
-BACKGROUND	The aim of this study was to present a systematic approach to plan process evaluation of the implementation of randomised multicomponent interventions .
-METHODS	Building on existing process evaluation frameworks and concepts , we developed a six-step protocol : 1 .
-METHODS	Brainstorm of processes necessary for full implementation and potential barriers and facilitators to implementation ; 2 .
-METHODS	Application of process evaluation concepts to ensure inclusion of important implementation processes ; 3 .
-METHODS	Measurement of proximal outcomes ; 4 .
-METHODS	Identification of relevant data sources ; 5 .
-METHODS	Selection of methods and timing of data collection of process measures ; 6 .
-METHODS	Development of instruments .
-METHODS	The protocol was applied to the Boost study , a multicomponent school-based dietary intervention .
-CONCLUSIONS	The protocol was readily applicable for planning process evaluation of environmental and educational intervention components in a school setting .
-CONCLUSIONS	The protocol ensures systematic assessment of the implementation processes that are crucial for interpretation of intervention effects .
-BACKGROUND	Current Controlled Trials ISRCTN11666034 .
-
-###25263038
-OBJECTIVE	To compare the outcomes of multifocal toric intraocular lens ( IOL ) implantation and standard nontoric multifocal IOL implantation combined with peripheral corneal relaxing incisions ( PCRIs ) in patients with moderate preexisting corneal astigmatism .
-METHODS	Moorfields Eye Hospital NHS Foundation Trust , London , United Kingdom .
-METHODS	Prospective randomized controlled trial .
-METHODS	Patients with visually significant cataract in both eyes who desired spectacle independence and had corneal astigmatism ( 1.00 to 2.50 diopters [ D ] ) had multifocal toric IOL implantation in 1 eye and a nontoric multifocal IOL combined with PCRIs ( Donnenfeld nomogram ) in the contralateral eye .
-METHODS	Outcome measures were visual acuity , astigmatic vector reduction , digital toric IOL axis determination , spectacle need , and patient satisfaction .
-RESULTS	Thirty patients were enrolled .
-RESULTS	Three months postoperatively , the mean residual refractive astigmatism was 0.45 D 0.49 ( SD ) in the toric IOL group and 0.72 0.61 D in the PCRI group .
-RESULTS	The mean uncorrected distance visual acuity was 0.10 0.14 in the toric IOL group and 0.15 0.14 in the PCRI group and the mean uncorrected near visual acuity , 0.43 0.11 and 0.39 0.10 , respectively .
-RESULTS	The mean absolute misalignment from the intended axis was 2.52 1.97 degrees .
-RESULTS	The rotation was within 3 degrees in 90.9 % of all cases and within 6 degrees in all cases .
-RESULTS	On the questionnaire , 52.9 % of all patients said they required spectacles only when reading for a long time .
-CONCLUSIONS	Although refractive astigmatism decreased in both groups , multifocal toric IOL implantation was predictable with good rotational stability .
-BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .
-
-###25455832
-OBJECTIVE	The purpose of this study was to examine the methodological integrity , sample size requirements , and short-term preliminary clinical outcomes of manual and manipulative therapy ( MMT ) in addition to a rehabilitation program for symptomatic knee osteoarthritis ( OA ) .
-METHODS	This was a pilot study of an assessor-blinded , randomized , parallel-group trial in 2 independent university-based outpatient clinics .
-METHODS	Participants with knee OA were randomized to 3 groups : 6 MMT sessions alone , training in rehabilitation followed by a home rehabilitation program alone , or MMT plus the same rehabilitation program , respectively .
-METHODS	Six MMT treatment sessions ( provided by a chiropractic intern under supervision or by an experienced chiropractor ) were provided to participants over the 4-week treatment period .
-METHODS	The primary outcome was a description of the research methodology and sample size estimation for a confirmatory study .
-METHODS	The secondary outcome was the short-term preliminary clinical outcomes .
-METHODS	Data were collected at baseline and 5weeks using the Western Ontario and McMasters Osteoarthritis Index questionnaire , goniometry for knee flexion/extension , and the McMaster Overall Therapy Effectiveness inventory .
-METHODS	Analysis of variance was used to compare differences between groups .
-RESULTS	Eighty-three patients were randomly allocated to 1 of the 3 groups ( 27 , 28 , and 28 , respectively ) .
-RESULTS	Despite 5 dropouts , the data from 78 participants were available for analysis with 10 % of scores missing .
-RESULTS	A minimum of 462 patients is required for a confirmatory 3-arm trial including the respective interventions , accounting for cluster effects and a 20 % dropout rate .
-RESULTS	Statistically significant and clinically meaningful changes in scores from baseline to week 5 were found for all groups for the Western Ontario and McMasters Osteoarthritis Index ( P .008 ) , with a greater change in scores for MMT and MMT plus rehabilitation .
-RESULTS	Between-group comparison did not reveal statistically significant differences between group scores at week 5 for any of the outcome measures ( P .46 ) .
-CONCLUSIONS	This pilot trial suggests that a confirmatory trial is feasible .
-CONCLUSIONS	There were significant changes in scores from baseline to week 5 across all groups , suggesting that all 3 treatment approaches may be of benefit to patients with mild-to-moderate knee OA , justifying a confirmatory trial to compare these interventions .
-
-###24560036
-OBJECTIVE	To assess , in a school-located adolescent vaccination program that billed health insurance , the program costs , the proportion of costs reimbursed , and the likelihood of vaccination .
-METHODS	During the 2010-2011 school year , vaccination clinics were held for sixth - to eighth-grade students at seven Denver public schools .
-METHODS	Vaccine administration and purchase costs were compared with reimbursement by insurers .
-METHODS	Multivariate analyses were used to compare the likelihood of vaccination among students in intervention schools with students in control schools who did not participate in the program , with analyses stratified by grade ( sixth grade vs. seventh-eighth grades ) .
-RESULTS	Fifteen percent ( 466 of 3,144 ) of students attending intervention schools were vaccinated at school-located vaccination clinics .
-RESULTS	Among students vaccinated at school , 41 % were uninsured , 37 % publicly insured , and 22 % privately insured .
-RESULTS	Estimated vaccine administration costs were $ 23.98 per vaccine dose .
-RESULTS	Seventy-eight percent of vaccine purchase costs and 14 % of vaccine administration costs were reimbursed by insurers ; 41 % of total program costs were reimbursed .
-RESULTS	Sixth-grade students in intervention schools were more likely than those in control schools to receive tetanus-diphtheria-acellular pertussis ( risk ratio [ RR ] , 1.30 ; 95 % confidence interval [ CI ] , 1.08 , 1.57 ) , meningococcal conjugate ( RR , 1.42 ; CI , 1.18 , 1.70 ) , and human papillomavirus ( for females only , RR , 1.69 ; CI , 1.21 , 2.36 ) vaccines during the 2010-2011 school year , with similar results for seventh - to eighth-grade students .
-CONCLUSIONS	Although school-located adolescent vaccination with billing appears feasible and likely to improve vaccination rates , improvements in insurance coverage and reimbursement rates may be needed for the long-term financial sustainability of such programs .
-
-###24759125
-OBJECTIVE	To examine protocol adherence to structured intensive management in the Valsartan Intensified Primary carE Reduction of Blood Pressure ( VIPER-BP ) study involving 119 primary care clinics and 1562 randomized participants .
-METHODS	Prospective criteria for assessing adherence to treatment prescription , uptitration , and visit attendance at 6 , 10 , 14 , and 18 weeks postrandomization were applied to 1038 intervention participants .
-METHODS	Protocol adherence scores of 1-5 ( least to most adherent ) were compared to blood pressure ( BP ) control during 26 weeks of follow-up .
-RESULTS	Mean age was 59.312.0 years , 963 ( 62 % ) were men , and 1045 ( 67 % ) had longstanding hypertension .
-RESULTS	Clinic attendance dropped from 91 ( week 6 ) to 83 % ( week 26 ) and pharmacological instructions were followed for 93 % ( baseline ) to 61 % at week 14 ( uptitration failures commonly representing protocol deviations ) .
-RESULTS	Overall , 26-week BP levels and BP target attainment ranged from 13214/799 and 51 % to 14115/8311 mmHg and 19 % in those participants subject to the highest ( n = 270 , 26 % ) versus least ( n = 148 , 14 % ) per protocol adherence , respectively ; adjusted relative risk ( RR ) 1.22 per unit protocol adherence score , 95 % confidence interval ( CI ) 1.15-1 .31 ; for achieving BP target ( P < 0.001 ) .
-RESULTS	Participants with a per protocol score of 4 or 5 ( 512/1038 , 49.3 % ) were 1.54-fold ( 95 % CI 1.31-1 .81 ; P < 0.001 ) more likely to achieve their individual BP target compared with usual care .
-RESULTS	Clinics equipped with a practice nurse significantly influenced protocol adherence ( adjusted RR 1.20 , 95 % CI 1.06-1 .37 ; P = 0.004 ) and individual BP control ( RR 1.21 , 95 % CI 1.04-1 .41 ; P = 0.015 ) .
-CONCLUSIONS	There is considerable potential for structured care management to improve BP control in primary care , especially when optimally applied .
-
-###24252844
-BACKGROUND	Rheumatoid arthritis ( RA ) is associated with heightened mortality due to atherosclerotic cardiovascular disease ( CVD ) .
-BACKGROUND	Inflammatory pathways in RA negatively affect vascular physiology and promote metabolic disturbances that contribute to CVD .
-BACKGROUND	We hypothesized that the peroxisome proliferator activated receptor - ( PPAR - ) pioglitazone could promote potent vasculoprotective and anti-inflammatory effects in RA .
-RESULTS	One hundred forty-three non-diabetic adult RA patients ( 76.2 % female , age 55.2 12.1 [ mean SD ] ) on stable RA standard of care treatment were enrolled in a randomized , double-blind placebo controlled crossover trial of 45 mg daily pioglitazone versus placebo , with a 3-month duration/arm and a 2-month washout period .
-RESULTS	Pulse wave velocity of the aorta ( PWV ) , brachial artery flow mediated dilatation ( FMD ) , nitroglycerin mediated dilatation ( NMD ) , microvascular endothelial function ( reactive hyperemia index [ RHI ] ) , and circulating biomarkers of inflammation , insulin resistance , and atherosclerosis risk all were quantified .
-RESULTS	RA disease activity was assessed with the 28-Joint Count Disease Activity Score ( DAS-28 ) C-reactive protein ( CRP ) and the Short Form ( 36 ) Health Survey quality of life questionnaire .
-RESULTS	When added to standard of care RA treatment , pioglitazone significantly decreased pulse wave velocity ( ie , aortic stiffness ) ( P = 0.01 ) , while FMD and RHI remained unchanged when compared to treatment with placebo .
-RESULTS	Further , pioglitazone significantly reduced RA disease activity ( P = 0.02 ) and CRP levels ( P = 0.001 ) , while improving lipid profiles .
-RESULTS	The drug was well tolerated .
-CONCLUSIONS	Addition of pioglitazone to RA standard of care significantly improves aortic elasticity and decreases inflammation and disease activity with minimal safety issues .
-CONCLUSIONS	The clinical implications of these findings remain to be established .
-BACKGROUND	ClinicalTrials.gov Unique Identifier : NCT00554853 .
-
-###24415446
-OBJECTIVE	The relation between inflammatory markers , adiposity and disease is under extensive study .
-OBJECTIVE	Here we tested the hypothesis that the immunomodulatory protein pentraxin 3 ( PTX3 ) is associated with adiposity in the general population .
-METHODS	Serum PTX3 concentrations , body mass index ( BMI ) , waist circumference ( WC ) and fat depots , as quantified by dual-energy X-ray absorptiometry and magnetic resonance imaging , were assessed in three community-based cohorts : ULSAM , n = 790 , mean age 78 years ; PIVUS , n = 1003 , mean age 70 years , women 50 % ; and the NORDIET-trial , n = 86 , mean age 53 years , women 63 % .
-METHODS	Participants were re-examined after 5 years ( PIVUS , n = 804 ) or following a 6-week randomized controlled dietary intervention ( NORDIET ) .
-RESULTS	PTX3 levels were inversely associated with BMI and WC as well as with total and visceral fat ( P < 0.05 for all ; adjusted for age , inflammatory biomarkers and cardiovascular risk factors ) .
-RESULTS	The association between PTX3 and BMI appeared even stronger in nonobese individuals .
-RESULTS	A decrease in BMI over 5 years as well as weight loss following the NORDIET intervention were associated with increased serum PTX3 concentrations ( P < 0.001 ) .
-CONCLUSIONS	These consistent data support an inverse association between circulating PTX3 and anthropometrical measures , calling for further mechanistic studies of the link between PTX3 and fat .
-
-###24491287
-BACKGROUND	Low colo-rectal anastomoses have a relevant risk of leakage .
-BACKGROUND	The protective stomas ( ileostomy or colostomy ) have always been utilized to reduce the complications due to anastomotic leakage .
-BACKGROUND	The stoma not only causes relevant morbidity but also needs a second operation to be closed , with an added risk of complications .
-OBJECTIVE	For this reason we planed and carried out a temporary percutaneous ileostomy by a jejunal probe introduced in the distal ileum , that can be removed without a surgical procedure and with negligible complications .
-METHODS	The ALPPI trial is a randomized controlled , open , parallel , equivalence multicenter study .
-METHODS	Patients undergoing elective laparoscopic or laparotomic surgery for rectal cancer with extraperitoneal anastomosis , will be randomly allocated to undergo either lateral ileostomy or percutaneous ileostomy by exclusion probe .
-RESULTS	The primary endpoint is the protection of the extraperitoneal colo-rectal anastomosis in terms of incidence of symptomatic and asymptomatic anastomotic leakages .
-RESULTS	The secondary endpoints are the evaluation of complications due to the placement and the removal of the exclusion probe for percutaneous ileostomy .
-CONCLUSIONS	The ALPPI trial is designed to provide the surgical community with an evidence based new technique in the protection of low colo-rectal anastomosis , alternative to the conventional stomas .
-BACKGROUND	The ALPPI trial was approved by the Ethical Committee of Regional Public Health System of Umbria , Italy , ( Protocol Number 28657/11/AV , study code RO-MA 01 ) and it is registered in the International Standard Randomised Controlled Trial Number ( ISRCTN ) Register with identification number ISRCTN99356919 .
-
-###25028689
-OBJECTIVE	To evaluate the short-term efficacy of agents containing KNO3 or casein phosphopeptide - amorphous calcium phosphate ( CPP-ACP ) in the treatment of dentin hypersensitivity .
-METHODS	UltraEZ , containing KNO3 and MI Paste , containing CPP-ACP were applied in this study .
-METHODS	The dentin hypersensitivity of 102 subjects was established by a tactile stimulus with a Yeaple preasure probe , and the degree of hypersensitivity was measured using a visual analogue scale ( VAS ) .
-METHODS	The patients were divided into four groups : A , B , C and D , using a random number table .
-METHODS	UltraEZ , a placebo of UltraEZ , MI Paste , and a placebo of MI Paste were applied to group A , B , C and D respectively for 2 weeks .
-METHODS	Dentin hypersensitivity was measured using VAS before the treatment ( baseline ) , on day 2 , 7 , and 14 during the treatment , and on day 30 and 60 posttreatment .
-RESULTS	The efficacy of UltraEZ on dentin hypersensitivity was significantly better than that of the corresponding placebo group on day 7 during the treatment , whereas the efficacy of MI Paste exhibited better than that of the placebo group on day 14 during the treatment .
-RESULTS	However , there were no differences between the efficacy of the two agents on day 14 during the treatment , day 30 or day 60 posttreatment .
-CONCLUSIONS	Both UltraEZ and MI Paste had a significant effect on dentin hypersensitivity .
-CONCLUSIONS	UltraEZ showed quicker effects than MI Paste , but MI Paste had a greater sustained action after treatment than UltraEZ .
-
-###25381471
-OBJECTIVE	This prospective randomized study compared acute and chronic anterior cruciate ligament ( ACL ) reconstruction using ligament advanced reinforcement system ( LARS ) artificial ligament in young active adults with a 5-year follow-up .
-METHODS	Fifty-five patients were enrolled in this study and divided into two groups based on the elapsed time between the injury and reconstruction : the acute group ( 3-7 weeks ) and the chronic group ( 6-11 months ) .
-METHODS	The clinical outcomes were evaluated using the Lysholm knee scoring scale , the Tegner activity rating , a KT-1000 Arthrometer , and the International Knee Documentation Committee ( IKDC ) scoring system .
-METHODS	Isokinetic strength of the quadriceps and hamstring was assessed using the Biodex System 3 isokinetic dynamometer .
-RESULTS	Anterior laxity was decreased and quadriceps/hamstring muscle strength was increased in the acute group compared to the chronic group ( p > 0.05 ) .
-RESULTS	There were no statistically significant differences in Lysholm scores , Tegner activity scores , and the IKDC evaluation form between the two groups .
-CONCLUSIONS	These results suggest that earlier ACL reconstruction using a LARS artificial ligament may provide an advantage in the treatment and rehabilitation of ACL rupture .
-
-###24760974
-BACKGROUND	The protein leverage hypothesis requires specific evidence that protein intake is regulated more strongly than energy intake .
-OBJECTIVE	The objective was to determine ad libitum energy intake , body weight changes , appetite profile , and nitrogen balance in response to 3 diets with different protein-to-carbohydrate + fat ratios over 12 consecutive days , with beef as a source of protein .
-METHODS	A 3-arm , 12-d randomized crossover study was performed in 30 men and 28 women [ mean SD age : 33 16 y ; body mass index ( in kg/m ) : 24.4 4.0 ] with the use of diets containing 5 % , 15 % , and 30 % of energy ( En % ) from protein , predominantly from beef .
-RESULTS	Energy intake was significantly lower in the 30En % - protein condition ( 8.73 1.93 MJ/d ) than in the 5En % - protein ( 9.48 1.67 MJ/d ) and 15En % - protein ( 9.30 1.62 MJ/d ) conditions ( P = 0.001 ) , stemming largely from lower energy intake during meals ( P = 0.001 ) .
-RESULTS	Hunger ( P = 0.001 ) and desire to eat ( P = 0.001 ) ratings were higher and fullness ratings were lower ( P = 0.001 ) in the 5En % - protein condition than in the 15En % - protein and 30En % - protein conditions .
-RESULTS	Nitrogen excretion was lower in the 5En % - protein condition ( 4.7 1.5 g/24 h ; P = 0.001 ) and was higher in the 30En % - protein condition ( 15.3 8.7 g/24 h ; P = 0.001 ) compared with the 15En % - protein condition ( 10.0 5.2 g/24 h ) .
-RESULTS	Nitrogen balance was maintained in the 5En % - protein condition and was positive in the 15En % - and 30En % - protein conditions ( P = 0.001 ) .
-CONCLUSIONS	Complete protein leverage did not occur because subjects did not consume to a common protein amount at the expense of energy balance .
-CONCLUSIONS	Individuals did underconsume relative to energy requirements from high-protein diets .
-CONCLUSIONS	The lack of support for protein leverage effects on a low-protein diet may stem from the fact that protein intake was sufficient to maintain nitrogen balance over the 12-d trial .
-
-###25035199
-OBJECTIVE	To compare hyperfractionation versus standard fractionation for T2N0 vocal cord carcinoma in a randomized controlled trial .
-METHODS	Patients with T2 vocal cord cancer were stratified by substage ( T2a vs T2b ) and randomly assigned to receive either hyperfractionation ( HFX ) to 79.2 Gy in 66 fractions of 1.2 Gy given twice a day , or standard fractionation ( SFX ) to 70 Gy in 35 fractions given once a day .
-METHODS	The trial was designed to detect a 55 % reduction in the local failure hazard rate with 80 % statistical power .
-RESULTS	Between April 1996 and July 2003 , a total of 250 patients were enrolled .
-RESULTS	Of 239 patients analyzable for outcomes , 94 % were male , 83 % had a Karnofsky performance status of 90-100 , and 62 % had T2a tumor .
-RESULTS	Median follow-up for all surviving patients was 7.9 years ( range , 0.6-13 .1 years ) .
-RESULTS	The 5-year local control ( LC ) rate was 8 points higher but not statistically significant ( P = .14 for HFX [ 78 % ] vs SFX [ 70 % ] ) , corresponding to a 30 % hazard rate reduction .
-RESULTS	The 5-year disease-free survival ( DFS ) was 49 % versus 40 % ( P = .13 ) and overall survival ( OS ) was 72 % versus 63 % ( P = .29 ) .
-RESULTS	HFX was associated with higher rates of acute skin , mucosal , and laryngeal toxicity .
-RESULTS	Grade 3-4 late effects were similar with a 5-year cumulative incidence of 8.5 % ( 3.4 % -13.6 % ) after SFX and 8.5 % ( 3.4 % -13.5 % ) after HFX .
-CONCLUSIONS	The 5-year local control was modestly higher with HFX compared to SFX for T2 glottic carcinoma , but the difference was not statistically significant .
-CONCLUSIONS	These results are consistent with prior studies of hyperfractionation showing a benefit in local control .
-CONCLUSIONS	Substaging by T2a versus T2b carries prognostic value for DFS and OS .
-CONCLUSIONS	For cost and convenience reasons other altered fractionation schedules have been adopted in routine practice .
-
-###24456504
-BACKGROUND	Surgery followed by radiotherapy and concomitant and adjuvant temozolomide is standard therapy in newly diagnosed glioblastoma multiforme ( GBM ) .
-BACKGROUND	Bevacizumab combined with irinotecan produces impressive response rates in recurrent GBM .
-BACKGROUND	In a randomized phase II study , we investigated the efficacy of neoadjuvant bevacizumab combined with irinotecan ( Bev-Iri ) versus bevacizumab combined with temozolomide ( Bev-Tem ) before , during and after radiotherapy in newly diagnosed GBM .
-METHODS	After surgery , patients were randomized to Bev-Iri or Bev-Tem for eight weeks , followed by standard radiotherapy ( 60 Gy/30 fractions ) and concomitant Bev-Iri or Bev-Tem followed by adjuvant Bev-Iri or Bev-Tem for another eight weeks .
-METHODS	Bev-Iri : Bevacizumab and irinotecan were given every 14 days before , during and after radiotherapy .
-METHODS	Bev-Tem : Bevacizumab was given as in Bev-Iri and temozolomide was given for five days every four weeks before and after radiotherapy and once daily during radiotherapy .
-METHODS	The primary endpoint was response after neoadjuvant chemotherapy and a pre-specified response rate of 30 % or more was considered of interest for future studies .
-METHODS	Secondary endpoints were progression-free survival ( PFS ) and toxicity .
-RESULTS	The response rate was 32 % ( 95 % CI 17-51 % ) for Bev-Tem ( n = 32 ) and 23 % ( 95 % CI 9-44 % ) for Bev-Iri ( n = 31 ) ( p = 0.56 ) .
-RESULTS	Median PFS was 7.7 and 7.3 months for Bev-Tem and Bev-Iri , respectively .
-RESULTS	Hematological toxicity was more frequent with Bev-Tem including one death from febrile neutropenia whereas non-hematological toxicity was manageable .
-CONCLUSIONS	Only the Bev-Tem arm met the pre-specified level of activity of interest .
-CONCLUSIONS	Our results did not indicate any benefit from Bev-Iri in first-line therapy as opposed to Bev-Tem in terms of response and PFS .
-
-###24359506
-BACKGROUND	Lifetime prevalence of amphetamine-induced psychotic disorder is reported as being up to 23 % for methamphetamine ( MA ) abusers .
-BACKGROUND	Approximately 25 % of those with a baseline DSM-IV diagnosis of substance-induced psychosis are diagnosed with primary psychosis at one-year follow-up .
-BACKGROUND	Evidence on the treatment of amphetamine psychosis is very limited .
-OBJECTIVE	To investigate the efficacy of risperidone versus aripiprazole in treatment of amphetamine-induced psychotic symptoms .
-METHODS	In a double-blind study , 45 participants were randomly allocated to either aripiprazole 15mg or risperidone 4mg daily over a six-week trial .
-METHODS	Positive and negative symptoms of psychosis were assessed using the Scale for Assessment of Negative Symptoms ( SANS ) and the Scale for Assessment of Positive Symptoms ( SAPS ) at baseline and completion of the trial .
-RESULTS	SANS and SAPS scores decreased significantly in both groups .
-RESULTS	Mean SAPS score reduction in risperidone and aripiprazole group was 16.20 and 10.80 , respectively , after trial course ( p < 0.001 ) .
-RESULTS	Mean SANS score reduction in risperidone and aripiprazole group was 9.35 and 11.25 , respectively ( p = 0.08 ) .
-CONCLUSIONS	Both aripiprazole and risperidone were effective for patients diagnosed with amphetamine-induced psychotic disorder .
-CONCLUSIONS	However , risperidone had the greater effect on positive psychotic symptoms while patients with negative symptoms may respond better to aripiprazole .
-CONCLUSIONS	There is a case for further studies evaluating the efficacy of atypical antipsychotics in this disorder .
-
-###25082565
-BACKGROUND	Concomitant administration of erlotinib with standard chemotherapy does not appear to improve survival among patients with non-small-cell lung cancer ( NSCLC ) , but preliminary studies suggest that sequential administration might be effective .
-OBJECTIVE	To assess the efficacy and tolerability of second-line sequential administration of erlotinib and docetaxel in advanced NSCLC .
-METHODS	In an open-label phase II trial , patients with advanced NSCLC , EGFR wild-type or unknown , PS 0-2 , in whom initial cisplatin-based chemotherapy had failed were randomized to sequential erlotinib 150 mg/d ( day 2-16 ) + docetaxel ( 75 mg/m ( 2 ) d1 ) ( arm ED ) or docetaxel ( 75 mg/m ( 2 ) d1 ) alone ( arm D ) ( 21-day cycle ) .
-METHODS	The primary endpoint was the progression-free survival rate at 15 weeks ( PFS 15 ) .
-METHODS	Secondary endpoints included PFS , overall survival ( OS ) , the overall response rate ( ORR ) and tolerability .
-METHODS	Based on a Simon optimal two-stage design , the ED strategy was rejected if the primary endpoint was below 33/66 patients at the end of the two Simon stages .
-RESULTS	147 patients were randomized ( median age : 608 years , PS 0/1/2 : 44/83/20 patients ; males : 78 % ) .
-RESULTS	The ED strategy was rejected , with only 18 of 73 patients achieving PFS15 in arm ED at the end of stage 2 and 17 of 74 patients in arm D.
-RESULTS	In arms ED and D , respectively , median PFS was 2.2 and 2.5 months and median OS was 6.5 and 8.3 months .
-CONCLUSIONS	Sequential erlotinib and docetaxel was not more effective than docetaxel alone as second-line treatment for advanced NSCLC with wild-type or unknown EGFR status .
-
-###24633268
-OBJECTIVE	The immunogenicity , reactogenicity and safety of the 10 - valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine ( PHiD-CV ) were evaluated in a cohort of Nigerian infants included in a study conducted in Mali and Nigeria ( ClinicalTrials.gov identifier : NCT00678301 ) .
-METHODS	In this open , randomised , controlled study , 119 healthy infants received combined diphtheria-tetanus-whole-cell pertussis-hepatitis B / Haemophilus influenzae type b vaccine ( DTPw-HBV/Hib ) and oral poliovirus vaccine ( OPV ) co-administered with PHiD-CV ( PHiD-CV group ) or without PHiD-CV ( control group ) at 6-10-14 weeks of age .
-METHODS	Pneumococcal antibody responses and opsonophagocytic activity were measured and adverse events were recorded .
-RESULTS	One month post-dose 3 , for each of the vaccine pneumococcal serotypes , e `` 90.1 % of PHiD-CV recipients had an antibody concentration e `` 0.2 ug/mL compared to < 9 % ( except for serotypes 14 [ 32.4 % ] and 19F [ 27.8 % ] ) in the control group .
-RESULTS	For each of the vaccine pneumococcal serotypes , e `` 90.6 % of infants in the PHiD-CV group had an OPA titre e `` 8 , compared to % 18 % ( except for serotype 7F [ 60.0 % ] ) in the control group .
-RESULTS	Anti-protein D antibody geometric mean antibody concentrations were 2949.7 EL.U / mL in the PHiD-CV group and 68.9 EL.U / mL in the control group .
-RESULTS	For each DTPw-HBV/Hib antigen antibody seroprotection/seropositivity rates were e `` 94.4 % .
-RESULTS	Tolerability was generally comparable between the PHiD-CV and control vaccination groups .
-CONCLUSIONS	PHiD-CV co-administered with routine vaccines was immunogenic for all vaccine pneumococcal serotypes and protein D in Nigerian infants .
-CONCLUSIONS	Vaccine tolerability was generally comparable between the PHiD-CV and control groups .
-CONCLUSIONS	These results suggest PHiD-CV can be co-administered with other vaccines included in the National Programme on Immunisation .
-
-###25190617
-BACKGROUND	Post-thrombotic syndrome ( PTS ) is a serious complication of deep vein thrombosis ( DVT ) of the leg that affects 20-50 % of patients .
-BACKGROUND	Once a patient experiences PTS there is no treatment that effectively reduces the debilitating complaints .
-BACKGROUND	Two randomised controlled trials showed that elastic compression stocking ( ECS ) therapy after DVT for 24 months can reduce the incidence of PTS by 50 % .
-BACKGROUND	However , it is unclear whether all patients benefit to the same extent from ECS therapy or what the optimal duration of therapy for individual patients should be .
-BACKGROUND	ECS therapy is costly , inconvenient , demanding and sometimes even debilitating .
-BACKGROUND	Tailoring therapy to individual needs could save substantial costs .
-BACKGROUND	The objective of the IDEAL DVT study , therefore , is to evaluate whether tailoring the duration of ECS therapy on signs and symptoms of the individual patient is a safe and effective method to prevent PTS , compared with standard ECS therapy .
-METHODS	A multicentre , single-blinded , allocation concealed , randomised , non-inferiority trial .
-METHODS	A total of 864 consecutive patients with acute objectively documented proximal DVT of the leg are randomised to either standard duration of 24 months or tailored duration of ECS therapy following an initial therapeutic period of 6 months .
-METHODS	Signs and symptoms of PTS are recorded at regular clinic visits .
-METHODS	Furthermore , quality of life , costs , patient preferences and compliance are measured .
-METHODS	The primary outcome is the proportion of patients with PTS at 24 months .
-BACKGROUND	Based on current knowledge the standard application of ECS therapy is questioned .
-BACKGROUND	The IDEAL DVT study will address the central questions that remain unanswered : Which individual patients benefit from ECS therapy and what is the optimal individual treatment duration ?
-BACKGROUND	Primary ethics approval was received from the Maastricht University Medical Centre .
-RESULTS	Results of the study will be disseminated via peer-reviewed publications and presentations at scientific conferences .
-BACKGROUND	NCT01429714 and NTR 2597 .
-
-###25270192
-OBJECTIVE	To evaluate the effect of newly designed positively aspherized progressive addition lenses ( PA-PALs ) , which reduce both lag of accommodation and hyperopic defocus on the peripheral retina , on the progression of early-onset myopia .
-METHODS	Positively aspherized-PALs have near addition and high positive distance zone aspherization comparable to the addition power .
-METHODS	One hundred ninety-seven children were enrolled , 6 to 12 years of age , with spherical equivalent refraction from -1.00 to -4.50 diopters ( D ) .
-METHODS	The children were randomized to receive one of three lenses : single vision lenses ( SVLs ) , PA-PALs with +1.0 D addition , or PA-PALs with +1.5 D addition .
-METHODS	Follow-up visits occurred every 6 months for 2 years .
-METHODS	The primary outcome was myopia progression evaluated by cycloplegic autorefraction .
-RESULTS	One hundred sixty-nine ( 86 % ) children completed the follow-up .
-RESULTS	Statistical analysis of adjusted progression rates showed a mean ( SE ) progression of -1.39 0.09 D in the control group wearing SVLs at the 24-month visit .
-RESULTS	Statistically significant ( P = 0.017 ) retardation of myopia progression ( 0.27 0.11 D during 24-month period or reduction ratio of 20 % ) by +1.5 D add PA-PALs relative to the SVLs was found , which was within the range of the percentage efficacy of myopia retardation by the conventional PALs in earlier trials over the same follow-up period .
-RESULTS	Nearly all retardation occurred in the first 12 months with no significant efficacy in the second year .
-RESULTS	Positively aspherized-PALs with +1.0 D addition showed negligible efficacy .
-CONCLUSIONS	To the extent that has been tested and that can be tolerated by wearers of spectacle lenses , the high positive aspherization of the distance zone added to PALs does not enhance their therapeutic efficacy in slowing myopia progression .
-CONCLUSIONS	( http://www.anzctr.org.au/ number , ACTRN12608000566336 ) .
-
-###24325104
-OBJECTIVE	To study the clinical effects of hypoxia preconditioning ( HPC ) and its effects on serum neuroglobin ( NGB ) and S-100B level in the patients undergoing intracranial aneurysm surgery .
-METHODS	Forty patients scheduled to intracranial aneurysm surgery were randomly.divided into 2 groups : HPC group ( n = 20 ) and control group ( n = 20 ) .
-METHODS	The patients in HPC group were treated with 3 cycles of deoxidation-reoxygenation after intubation .
-METHODS	The time of deoxidation in each HPC cycle was recorded , while vital signs were also recorded in each corresponding time point .
-METHODS	Blood samples were obtained from exsanguinate radial artery and jugular bulb section at the end of each HPC cycle and corresponding time points during operation to measure serum level of NGB and S100B protein and to analysis blood gas .
-RESULTS	During HPC process , the patients in group HPC experienced mild hypoxia and CO2 retention .
-RESULTS	With the times of HPC increasing , CO2 retention degree became heavier ( P < 0.05 ) while hypoxia improved , the patients need more time to make SpO2 from 100 % to 90 % ( P < 0.05 ) .
-RESULTS	From T2 to T4 ( the end of the third reoxygenation , during skull opened and aneurysm dipped , skull closed ) , NGB in group HPC was higher than that in control ( P < 0.05 ) , but S-100B level was not different between HPC and control group ( P > 0.05 ) .
-CONCLUSIONS	HPC could induce compensatory ability of the body to hypoxia , which might be related to the up-regulation of NGB expression .
-
-###24834892
-OBJECTIVE	The purpose of this study was to assess pulmonary lesion detection , diagnostic confidence , and noise reduction in sparse-sampled ( SpS ) computed tomographic ( CT ) data of submillisievert ( SubmSv ) chest CT reconstructed with iterative reconstruction technique ( IRT ) .
-METHODS	This Human Insurance Portability and Accountability-compliant , institutional review board-approved prospective study was performed using SpS-SubmSv IRT chest CT in 10 non-obese patients ( body-mass index , 21-35 kg/m ; age range , 26-90 years ) .
-METHODS	Written informed consent was obtained .
-METHODS	The patients were scanned at standard-dose CT ( mean [ SD ] volumetric CT dose index , 6 [ 0.9 ] mGy ; mean [ SD ] dose-length product , 208 44 mGycm ; and mean [ SD ] effective dose , 3 [ 0.6 ] mSv ) and at SubmSv dose ( 1.8 [ 0.2 ] mGy , 67 [ 2 ] mGycm , 0.9 [ 0.03 ] mSv , respectively ) on a Philips 128-slice CT scanner with double z-sampling .
-METHODS	Sparse angular sampling data were reconstructed using 25 % of the angular projections from the SubmSv sinogram to reduce the number of views and radiation dose by approximately 4-fold .
-METHODS	Hence , the patients were scanned and then , simulation-based sparse sampling was performed with a resultant dose hypothetical SpS scan estimated mathematically ( 0.2 mSv ) .
-METHODS	From each patient data , 3 digital imaging and communications in medicine series were generated : SpS-SubmSv with IRT , fully sampled SubmSv filtered back projection ( FBP ) , and fully sampled standard-dose FBP ( SD-FBP ) .
-METHODS	Two radiologists independently assessed these image series for detection of lung lesions , visibility of small structures , and diagnostic acceptability .
-METHODS	Objective noise was measured in the thoracic aorta , and noise spectral density was obtained for SpS-SubmSv IRT , SubmSv-FBP , and SD-FBP .
-RESULTS	The SpS-SubmSv IRT resulted in 75 % ( 0.2 / 0.9 mSv ) and 92 % ( 0.2 / 2.9 mSv ) dose reduction , when compared with the fully sampled SubmSv-FBP and SD-FBP , respectively .
-RESULTS	Images of SpS-SubmSv displayed all 46 lesions ( most < 1 cm , 30 lung nodules , 7 ground glass opacities , 9 emphysema ) seen on the SubmSv-FBP and SD-FBP data sets .
-RESULTS	Lesion margins with sparse-sampled data were deemed acceptable compared with both SubmSv-FBP and SD-FBP .
-RESULTS	Overall diagnostic confidence was maintained with SpS-SubmSv IRT despite the presence of minor pixilation artifacts in 3 of 10 cases .
-RESULTS	The SpS-SubmSv IRT showed 63 % and 38 % noise reduction when compared with SubmSv-FBP ( P < 0.0001 ) and SD-FBP ( P < 0.01 ) , respectively , with no significant change in Hounsfield unit values ( P > 0.05 ) .
-RESULTS	Noise-spectral density showed that SpS-SubmSv IRT gives a linear decrease over frequency in the semilog plot and an exponential decrease of noise power over frequency compared with SubmSv-FBP and SD-FBP .
-CONCLUSIONS	More than 90 % dose reduction could be achieved with one-fourth sparse-sampled and SubmSv chest CT examination when reconstructed with IRT .
-CONCLUSIONS	Chest CT dose at one fourth of a millisievert with SpS is possible with optimal lesion detection and diagnostic confidence for the evaluation of pulmonary findings .
-
-###25436448
-OBJECTIVE	A number of interventions for at-risk children have shown benefits for children 's hypothalamic-pituitary-adrenal axis activity immediately after treatment .
-OBJECTIVE	It is critical to examine whether such changes are maintained over time , given that physiological regulation is implicated in later mental and physical health outcomes .
-OBJECTIVE	To examine whether differences in diurnal cortisol production between children receiving the active parenting intervention and children in the control group persisted at a preschool follow-up ( approximately 3 years following intervention ) .
-METHODS	Between-subject comparison of cortisol patterns among 2 groups of children ( experimental and control groups ) involved with Child Protective Services following allegations of neglect .
-METHODS	The participants included 115 children ( 43.5 % female ) between 46.5 and 69.6 months of age ( mean [ SD ] , 50.73 [ 4.98 ] months ) who had been previously randomly assigned to either the Attachment and Biobehavioral Catch-up ( ABC ) intervention ( n = 54 ) or the control intervention ( n = 61 ) .
-METHODS	The experimental ABC intervention focused on 3 aims : increasing parental nurturance to child distress , increasing synchronous interactions , and decreasing frightening parental behavior .
-METHODS	The control intervention provided educational information about child development to parents .
-METHODS	Both interventions were manualized and involved 10 sessions implemented by a trained parent coach in the families ' homes or other places of residence .
-METHODS	Salivary cortisol samples collected at waking and bedtime for children on 3 separate days .
-RESULTS	Analyses revealed significant differences in cortisol production at the preschool follow-up , such that children in the ABC intervention group showed more typical patterns of cortisol production than children in the control intervention group .
-RESULTS	Specifically , children in the ABC group exhibited higher mean ( SD ) log-transformed morning levels than children in the control group ( -0.87 [ 0.45 ] vs -1.05 [ 0.43 ] g/dL , respectively [ to convert to nanomoles per liter , multiply by 27.588 ] ; = 0.18 ; P = .03 ) .
-RESULTS	Bedtime cortisol levels did not differ significantly between the ABC and DEF groups ( mean [ SD ] , -1.19 [ 0.49 ] vs -1.17 [ 0.48 ] g/dL , respectively ; 01 = -0.01 ; P = .87 ) .
-RESULTS	Those in the ABC group showed a steeper decline in cortisol across the day ( mean , -0.31 g/dL ) than those in the control group , who showed a blunted cortisol rhythm ( mean , -0.12 g/dL ) ( = -0.19 ; P = .02 ) .
-CONCLUSIONS	Differences in cortisol production between the experimental and control groups persisted at the preschool follow-up and resembled differences initially observed 3 months following intervention .
-CONCLUSIONS	This is encouraging evidence that the ABC intervention for Child Protective Services-referred children may have long-lasting effects on a physiological stress system critical for health and adjustment .
-BACKGROUND	clinicaltrials.gov Identifier : NCT02093052 .
-
-###25491499
-OBJECTIVE	Middle Eastern female immigrants are at an increased risk of vitamin D deficiency and their response to prescribed vitamin D dosages may not be adequate and affected by other factors .
-OBJECTIVE	The objectives were to determine vitamin D deficiency and its determinants in Middle Eastern women living in Auckland , New Zealand ( Part-I ) , and to determine serum 25-hydroxyvitamin D ( serum-25 ( OH ) D ) response to two prescribed vitamin D dosages ( Part-II ) in this population .
-METHODS	Women aged 20 ( n = 43 ) participated in a cross-sectional pilot study during winter ( Part-I ) .
-METHODS	In Part-II , women aged 20-50 years ( n = 62 ) participated in a randomised , double-blind placebo-controlled trial consuming monthly either 50,000 , 100,000 IU vitamin D3 or placebo for 6 months ( winter to summer ) .
-RESULTS	All women in Part-I and 60 % women in Part-II had serum-25 ( OH ) D < 50nmol/l .
-RESULTS	Serum-25 ( OH ) D was higher in prescribed vitamin D users than nonusers ( P = 0.001 ) and in Iranians than Arab women ( P = 0.001 ; Part-I ) .
-RESULTS	Mean ( s.d. ) serum-25 ( OH ) D increased in all groups ( time effect , P < 0.001 ) and differed between groups ( time dosage interaction , P < 0.001 ; 50,000 IU : from 44.016.0 to 70.015.0 nmol/l ; 100,000 IU : 48.011.0 to 82.017.0 nmol/l ; placebo : 45.018.0 to 54.018.0 nmol/l ) .
-RESULTS	Only 32 % and 67 % achieved serum-25 ( OH ) D75nmol/l with 50,000 and 100,000 IU/month , respectively .
-RESULTS	Predictors of 6-month change in serum-25 ( OH ) D were dose ( B-coefficients .
-RESULTS	e. ; 14.12.4 , P < 0.001 ) , baseline serum-25 ( OH ) D ( -0.60.1 , P < 0.001 ) and body fat percentage ( -0.70.3 , P = 0.01 ) .
-CONCLUSIONS	Vitamin D deficiency/insufficiency is highly prevalent in this population .
-CONCLUSIONS	Monthly 100,000 IU vitamin D for 6 months is more effective than 50,000 IU in achieving serum-25 ( OH ) D 75nmol/l ; however , a third of women still did not achieve these levels .
-
-###25293355
-OBJECTIVE	Growing , small , peripheral , pulmonary nodules in patients at high risk for lung cancer lead to requests for video-assisted thoracoscopic ( VATS ) resection for pathologic diagnosis .
-OBJECTIVE	The purpose of this randomized controlled trial was to determine if preoperative localization using percutaneously placed computed tomography ( CT ) - guided platinum microcoils decreases the need for thoracotomy or VATS anatomic resection ( segmentectomy/lobectomy ) for diagnosis .
-METHODS	Patients with undiagnosed nodules of 15 mm or less were randomized to either no localization or preoperative microcoil localization .
-METHODS	Coils were placed with the distal end deep to the nodule and the superficial end coiled on the visceral pleural surface with subsequent visualization by intraoperative fluoroscopy and VATS.Nodules were removed by VATS wedge excision using endostaplers .
-METHODS	The primary outcome was a VATS wedge excision for pathologic diagnosis of the nodule without the need for either thoracotomy or VATS anatomic resection .
-RESULTS	Sixty patients were randomized and 56 underwent surgery between March 2010 and June 2012 .
-RESULTS	Twenty-nine underwent microcoil localization and 27 did not .
-RESULTS	The baseline characteristics ( age , sex , forced expiratory volume in the first second of expiration , nodule size/depth ) were similar .
-RESULTS	The coil group had a higher rate of successful diagnosis with VATS wedge resection alone ( 27/29 vs 13/27 ; P < .001 ) , decreased operative time to nodule excision ( 37 39 vs 100 67 minutes ; P < .001 ) , and reduced stapler firings ( 3.7 2.0 vs 5.9 31 ; P = .003 ) with no difference in total costs .
-RESULTS	Pathologic diagnoses included 14 benign nodules , 32 primary lung malignancies , and 10 metastases .
-RESULTS	There were no clinically significant complications related to the coil placement or wedge resection .
-CONCLUSIONS	Preoperative CT-guided microcoil localization decreases the need for thoracotomy or VATS anatomic resection for the diagnosis of small peripheral pulmonary nodules .
-
-###24447110
-BACKGROUND	Glycolic acid ( GA ) peels are frequently performed as adjuvants to the treatment of facial acne .
-BACKGROUND	There have been few clinical trials reported of GA peels for acne in people with darker skin .
-OBJECTIVE	To determine the safety and efficacy of GA peels in the treatment of moderate acne vulgaris in Asian skin .
-METHODS	In this prospective , randomized , double-blind , placebo-controlled , split-face clinical trial , 26 patients with moderate acne were treated with 40 % GA ( pH 2.0 ) on half of the face and placebo on the other half .
-METHODS	The procedure was performed five times at 2-week intervals .
-RESULTS	The GA sides had statistically significant reductions in acne lesions at each time point from baseline values .
-RESULTS	There were statistically significant differences between the GA and placebo sides .
-RESULTS	The GA sides had better responses for noninflammatory lesions than for inflammatory lesions .
-RESULTS	In bioengineering measurements , sebum levels were statistically significantly reduced after the initiation of therapy on both sides at weeks 8 and 10 , but there were no statistically significant differences between the two sides .
-CONCLUSIONS	Forty percent GA peels significantly improved moderate acne in this study .
-CONCLUSIONS	It is effective and safe in Asians .
-
-###24292559
-OBJECTIVE	Self-management is promoted as a strategy for improving outcomes for serious mental illness as well as for chronic general medical conditions .
-OBJECTIVE	This study evaluated the feasibility and effectiveness of an eight-month program combining training in self-management for both psychiatric and general medical illness , including embedded nurse care management .
-METHODS	Participants were 71 middle-aged and older adults ( mean age = 60.3 6.5 ) with serious mental illness and chronic general medical conditions who were randomly assigned to receive integrated Illness Management and Recovery ( I-IMR ) ( N = 36 ) or usual care ( N = 35 ) .
-METHODS	Feasibility was determined by attendance at I-IMR and nurse sessions .
-METHODS	Effectiveness outcomes were measured two and six months after the intervention ( ten - and 14-month follow-ups ) and included self-management of psychiatric and general medical illness , participation in psychiatric and general medical encounters , and self-reported acute health care utilization .
-RESULTS	I-IMR participants attended 15.8 9.5 I-IMR and 8.2 5.9 nurse sessions , with 75 % attending at least ten I-IMR and five nurse sessions .
-RESULTS	Compared with usual care , I-IMR was associated with greater improvements in participant and clinician ratings for psychiatric illness self-management , greater diabetes self-management , and an increased preference for detailed diagnosis and treatment information during primary care encounters .
-RESULTS	The proportion of I-IMR participants with at least one psychiatric or general medical hospitalization decreased significantly between baseline and ten - and 14-month follow-ups .
-CONCLUSIONS	I-IMR is a feasible intervention for this at-risk group and demonstrated potential effectiveness by improving self-management of psychiatric illness and diabetes and by reducing the proportion of participants requiring psychiatric or general medical hospitalizations .
-
-###24932989
-OBJECTIVE	To compare contrast sensitivity , visual acuity ( VA ) , and halos in subjects bilaterally implanted with 1 of 3 FDA-approved presbyopia-correcting intraocular lenses .
-METHODS	Prospective , randomized , partially masked , multicenter clinical trial .
-METHODS	Seventy-eight subjects were randomized sequentially for bilateral implantation with the Crystalens AO ( Bausch & Lomb Surgical ) , AcrySof IQ ReSTOR +3.0 ( Alcon Laboratories ) , or Tecnis Multifocal ( Abbott Medical Optics ) lenses .
-METHODS	Subjects were evaluated through visit 4 ( 4 to 6months after surgery ) with the following monocular and binocular assessments : high - and low-contrast VA , contrast sensitivity without glare , halos or starbursts , defocus curves , optical scatter , retinal point spread function , and safety .
-RESULTS	The Crystalens AO and ReSTOR +3.0 demonstrated better monocular and binocular contrast sensitivity without glare at low to mid spatial frequencies compared with the Tecnis Multifocal lens .
-RESULTS	Binocular uncorrected distance VA was not significantly different between the 3 lenses .
-RESULTS	The Crystalens AO had significantly better binocular low-contrast distance-corrected VA than the ReSTOR +3.0 and better mean monocular low-contrast DCVA than the Tecnis Multifocal lens .
-RESULTS	The Crystalens AO demonstrated significantly better monocular and binocular uncorrected and distance-corrected intermediate VA than the ReSTOR +3.0 or Tecnis Multifocal lenses .
-RESULTS	The ReSTOR +3.0 lens had significantly better monocular and binocular uncorrected and distance-corrected near VA tested at 40cm compared with the Crystalens AO and Tecnis Multifocal lens .
-RESULTS	The Crystalens AO elicited significantly less halos than the Tecnis Multifocal lens and less optical scatter than the ReSTOR +3.0 or Tecnis Multifocal lens .
-CONCLUSIONS	The Crystalens AO had statistically better uncorrected intermediate VA and distance-corrected intermediate VA than the ReSTOR +3.0 or Tecnis Multifocal lenses and fewer photic phenomenon than the Tecnis Multifocal lens .
-CONCLUSIONS	Both multifocals had better distance-corrected near VA and uncorrected near VA than the Crystalens AO .
-CONCLUSIONS	These findings may guide intraocular lens selection for individual patients seeking to optimize vision at specific vergences or lighting conditions .
-
-###24418865
-OBJECTIVE	This study sought to evaluate the efficacy of the isolated use of tacrolimus compared with the combined use of tacrolimus and olopatadine for the treatment of severe vernal keratoconjunctivitis ( VKC ) .
-METHODS	Twenty-one patients with severe VKC were randomized into two groups : one treated with 0.03 % tacrolimus ointment combined with 1 % olopatadine ophthalmic solution and the other with 0.03 % tacrolimus ointment combined with placebo eye drops .
-METHODS	The clinical signs and symptoms were graded from 0 to 3 , and the efficacy of treatment was determined by the difference between the score at the beginning of treatment and after 30 days .
-METHODS	The clinical impression of improvement as perceived by the evaluator and the self-assessment provided by the patient were scored at day 30 of treatment and compared between the groups .
-RESULTS	The scores for symptoms decreased between the assessments in both groups ( -1.73.9 in the experimental group ; -0.61.6 in the control group ) , with no significant difference between groups ( P = 0.205 ) .
-RESULTS	The scores for clinical signs decreased between the assessments in the experimental group ( -1.12.7 ) and increased in the control group ( 0.30.9 ) but with no significant differences ( P = 0.205 ) .
-RESULTS	There was no significant difference between the groups regarding the self-assessment ( P = 0.659 ) and the clinical impression of the evaluator ( P = 0.387 ) .
-CONCLUSIONS	The isolated use of tacrolimus and the combined use of tacrolimus and olopatadine seems to have the same efficacy , although controlled studies with larger samples are required to confirm this hypothesis .
-
-###25377567
-BACKGROUND	The determination of dosing regimens for the treatment of malaria is largely empirical and thus a better understanding of the pharmacokinetic/pharmacodynamic properties of antimalarial agents is required to assess the adequacy of current treatment regimens and identify sources of suboptimal dosing that could select for drug-resistant parasites .
-BACKGROUND	Mefloquine is a widely used antimalarial , commonly given in combination with artesunate .
-METHODS	Mefloquine pharmacokinetics was assessed in 24 healthy adults and 43 patients with Plasmodium falciparum malaria administered mefloquine in combination with artesunate .
-METHODS	Population pharmacokinetic modelling was conducted using NONMEM .
-RESULTS	A two-compartment model with a single transit compartment and first-order elimination from the central compartment most adequately described mefloquine concentration-time data .
-RESULTS	The model incorporated population parameter variability for clearance ( CL/F ) , central volume of distribution ( VC/F ) and absorption rate constant ( KA ) and identified , in addition to body weight , malaria infection as a covariate for VC/F ( but not CL/F ) .
-RESULTS	Monte Carlo simulations predict that falciparum malaria infection is associated with a shorter elimination half-life ( 407 versus 566 h ) and T > MIC ( 766 versus 893 h ) .
-CONCLUSIONS	This is the first known population pharmacokinetic study to show falciparum malaria to influence mefloquine disposition .
-CONCLUSIONS	Protein binding , anaemia and other factors may contribute to differences between healthy individuals and patients .
-CONCLUSIONS	As VC/F is related to the earlier portion of the concentration-time profiles , which occurs during acute malaria , and CL/F is more related to the terminal phase during convalescence after treatment , this may explain why malaria was found to be a covariate for VC/F but not CL/F .
-
-###25056151
-BACKGROUND	Tinnitus occurs in a large part of the general population with prevalences ranging from 10 % to 15 % in an adult population .
-BACKGROUND	One subtype is cervicogenic somatic tinnitus , arising from cervical spine dysfunctions , justifying cervical spine assessment and treatment .
-BACKGROUND	This study aims to investigate the effect of a standardized physical therapy treatment , directed to the cervical spine , on tinnitus .
-BACKGROUND	Additionally , a second aim is to identify a subgroup within the tinnitus population that benefits from physical therapy treatment .
-METHODS	This study is designed as a randomized controlled trial with delayed treatment design .
-METHODS	Patients with severe subjective tinnitus ( Tinnitus Functional Index ( TFI ) between 25 and 90 points ) , in combination with neck complaints ( Neck Bournemouth Questionnaire ( NBQ ) > 14 points ) will be recruited from the University Hospital of Antwerp .
-METHODS	Patients suffering from tinnitus with clear otological etiologies , severe depression , traumatic cervical spine injury , tumors , cervical spine surgery , or conditions in which physical therapy is contra-indicated , will be excluded.After screening for eligibility , baseline data such as TFI , NBQ , and a set of cervical biomechanical and sensorimotor tests will be collected .
-METHODS	Patients are randomized in an immediate therapy group and in a group with a delayed start of therapy by 6 weeks .
-METHODS	Patients will receive physical therapy with a maximum of 12 sessions of 30 min for a 6-week program .
-METHODS	Data from the TFI and NBQ will be collected at baseline ( week 0 ) , at the start of therapy ( weeks 0 or 6 ) , at the end of therapy ( weeks 6 or 12 ) , 6 weeks after therapy ( weeks 12 or 18 ) , and 3 months after therapy ( weeks 18 or 24 ) .
-METHODS	Secondary outcome measures will be collected at baseline and 6 weeks after the therapy ( weeks 12 or 18 ) , as the maximal therapy effect on the cervical spine dysfunctions is expected at that moment .
-CONCLUSIONS	This study is the first to investigate the effect of a standardized physical therapy treatment protocol on somatic tinnitus with a prospective comparative delayed design and with blinded evaluator for baseline , end of therapy , and 6 and 12 weeks after therapy .
-BACKGROUND	12 September 2013 , ClinicalTrials.gov : NCT02016313 .
-
-###24375159
-BACKGROUND	Inflammation is involved in development , progression , and complications of atherosclerotic disease .
-BACKGROUND	Clinical studies have indicated that the level of monocyte chemoattractant protein 1 ( MCP-1 ) , IL-18 , and adhesion molecules correlates with the severity of atherosclerosis and can predict future cardiovascular events .
-BACKGROUND	Experimental studies have shown pentoxifylline ( PTX ) reduces these factors in animal models .
-BACKGROUND	The purpose of the present pilot study was to evaluate effect of PTX on a group of inflammatory biomarkers in patients with coronary artery disease ( CAD ) .
-METHODS	Forty patients with angiographically documented CAD , who fulfilled inclusion and exclusion criteria , were entered in the double-blind , randomized , pilot clinical study .
-METHODS	The patients were randomly given PTX ( 400 mg three times daily ) or placebo ( 3 tab/day ) for 2 months .
-METHODS	Serum concentrations of MCP-1 , IL-18 , intercellular adhesion Molecule 1 ( ICAM-1 ) , and vascular cell adhesion molecule 1 ( VCAM-1 ) were measured before and at the end of intervention by enzyme-linked immunosorbant assay .
-RESULTS	Our study showed that the serum levels of ICAM-1 and VCAM-1 was decreased in the study population after two-month treatment ( P < 0.05 ) .
-CONCLUSIONS	Based on the results of our pilot study , administration of PTX in CAD patients significantly decreases adhesion molecules levels .
-
-###24284025
-BACKGROUND	The incremental prognostic value of high-sensitive troponin T ( hs-cTnT ) in heart failure ( HF ) beyond that of high-sensitivity C-reactive protein and amino-terminal probrain natriuretic peptide is debated .
-BACKGROUND	We examined the prognostic value of hs-cTnT in a subgroup of patients from the Controlled Rosuvastatin Multinational Trial in HF ( CORONA ) study .
-RESULTS	Hs-cTnT as a risk factor for the primary end point ( cardiovascular death , nonfatal myocardial infarction , and nonfatal stroke ; n = 356 ) , as well as all-cause mortality ( n = 366 ) , cardiovascular mortality ( n = 299 ) , and the composite of cardiovascular mortality and hospitalization from worsening of HF ( n = 465 ) , was investigated in 1245 patients ( 60 years ; New York Heart Association [ NYHA ] class II-IV , ischemic systolic HF ) randomly assigned to 10 mg rosuvastatin or placebo .
-RESULTS	In multivariable analyses , adjusting for left ventricular ejection fraction , NYHA class , age , body mass index , diabetes mellitus , sex , intermittent claudication , heart rate , estimated glomerular filtration rate , apolipoprotein B/apolipoprotein A-1 ratio , amino-terminal probrain natriuretic peptide , high-sensitivity C-reactive protein , and hs-cTnT ( both dichotomized according to the 99th percentile and as a continuous variable ) was associated with all end points ( primary end point : hazard ratio , 1.87 and 1.51 , respectively , per SD change ; P < 0.001 ; all other end points : hazard ratio , 1.39-1 .70 ) .
-RESULTS	However , improved discrimination as assessed by C-statistics was only seen for the primary end point and all-cause mortality .
-CONCLUSIONS	Elevated hs-cTnT levels provide strong and independent prognostic information in older patients with chronic ischemic HF .
-BACKGROUND	URL : http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00206310 .
-
-###24548148
-OBJECTIVE	To assess the impact of listening to preferred music on relieving male patients ' pain and anxiety during flexible cystoscopy .
-METHODS	A total of 124 male patients were admitted to our hospital for flexile cystoscopy by a single urologist between January 2013 and September 2013 and randomized to two equal groups .
-METHODS	Group 2 included 62 patients who could select and listen to their preferred music during flexible cystoscopy .
-METHODS	Group 1 included 62 patients who were unable to listen to the music .
-METHODS	All patients were administered the same amount of lidocaine ( 10 mL ) for 3 minutes for local anesthesia before flexible cystoscopy .
-METHODS	A visual analog scale ( VAS ) ranging from 0 to 10 was used to assess patients ' pain feeling after the cystoscopy procedure .
-METHODS	Anxiety levels were calculated according to the State Instrument of State-Trait Anxiety Inventory ( STAI-S ) , and the pulse rate were recorded 5 minutes before and immediately after the procedure .
-METHODS	The duration of the procedure of each group were also analyzed .
-RESULTS	Statistically significant differences were detected between group 1 and group 2 in the mean pain score on VAS ( 2.53 1.34 vs 1.63 1.09 , P = 0.002 , Mann-Whitney U test ) , mean postprocedural State Anxiety Inventory pain score ( 39.4 6.5 vs 34.5 5.8 ) , and postprocedural pulse rate ( 79.8 5.5 vs 76.0 7.3 ) ( P < 0.001 for both , t test ) .
-RESULTS	Patients who listened to their preferred music experienced less discomfort and lower anxiety at cystoscopy .
-RESULTS	Patient age , duration of the procedure , preprocedural STAI-S , and preprocedural pulse rate of each group were comparable .
-CONCLUSIONS	Listening to preferred music during flexible cystoscopy is an easy way to improves male patients ' comfort and reduce their anxiety .
-CONCLUSIONS	It could be recommended for male patients .
-
-###24946226
-OBJECTIVE	Postoperative sore throat is one of the most common problems after tonsillectomy .
-OBJECTIVE	Antibiotics remove the local flora and reduce inflammation and thus may reduce postoperative pain after tonsillectomy .
-OBJECTIVE	To assess the effect of topical sucralfate and clindamycin on local pain reduction after tonsillectomy in children aged 6 to 12 years .
-METHODS	Triple-blind randomized clinical trial of children aged 6 to 12 years with sleep apnea or snoring due to adenotonsillar hypertrophy and chronic airway obstruction or with chronic infections who were candidates for tonsillectomy at Besat Hospital , Hamadan University of Medical Sciences , from May to October 2013 .
-METHODS	Patients were randomly assigned to receive sucralfate mouthwash , clindamycin mouthwash , or placebo ( cellulose ) .
-METHODS	The oral cavity was washed before and immediately after surgery with 10 mL of the prepared solution for 1 minute and then suctioned .
-METHODS	Then , 8 hours after surgery , the patients were asked to keep 10 mL of the prepared mouthwash solution in their mouths for 1 minute 3 times a day for 3 days .
-METHODS	Postoperative sore throat evaluated daily for 5 days using the Faces Pain Scale-Revised .
-RESULTS	Of 110 patients enrolled , 101 patients remained for analysis .
-RESULTS	Patients in the placebo group had significantly higher mean ( SD ) throat pain scores than did patients in both drug groups on postsurgery days 1 through 4 .
-RESULTS	Day 1 scores were 8.00 ( 1.84 ) for placebo and 6.00 ( 1.84 ) for sucralfate and 6.79 ( 1.87 ) for clindamycin ( P = .001 ) .
-RESULTS	Pain scores were not significantly different on day 5 .
-RESULTS	Acetaminophen use was more common in the placebo group on days 3 and 4 ( 2.97 and 2.44 ) vs the sucralfate group ( 2.24 and 2.15 ) and the clindamycin group ( 2.36 and 2.12 ) ( P = .001 and .02 , respectively ) .
-RESULTS	Bleeding on day 1 was more common in the placebo group ( 3 of 34 ) vs none in the drug groups .
-RESULTS	Food intolerance on day 1 was less common in patients receiving sucralfate ( 2 of 34 ) than placebo ( 9 of 34 ) or clindamycin ( 11 of 33 ) ( P = .02 ) .
-RESULTS	There was no significant difference among the 3 groups in numbers of episodes of nocturnal waking , halitosis , earache , nausea , and vomiting .
-CONCLUSIONS	This trial indicated that topical sucralfate and clindamycin are safe drugs with no important adverse effects that can significantly reduce posttonsillectomy pain in children and help them return to normal life sooner .
-BACKGROUND	Iranian Registry of Clinical Trials registration number : IRCT201303209014N16 .
-
-###25355194
-BACKGROUND	Despite all the technological advances in orthodontics , orthodontic treatment still seems to involve some degree of discomfort and/or pain .
-BACKGROUND	Pain control during orthodontic therapy is of great concern to both orthodontists and patients .
-BACKGROUND	However , there has been limited research into controlling such pain .
-OBJECTIVE	The purpose of this work was to assess patient-perceived pain following fixed orthodontic treatment and to evaluate the comparative analgesic efficacy of non-steroidal anti-inflammatory drugs for controlling pain .
-METHODS	A total of 45patients about to undergo fixed appliance orthodontic treatment were enrolled in this double-blind prospective study .
-METHODS	Patients were evenly and randomly distributed in a blinded manner to one of three groups as follows : paracetamol/acetaminophen 500mg thrice daily ; placebo in the form of empty capsules ; and etoricoxib 60mg once daily .
-METHODS	Drug administration began 1h before initiating the bonding procedure and archwire placement , and given until the day3 .
-METHODS	The pain perceived was recorded by the patients on a linear and graded Visual Analogue Scale at time intervals of 2h after insertion of the appliance ; 6h thereafter and again at nighttime of the same day of the appointment ; 24h later and on the 2nd day at nighttime ; 48h after the appointment and on day3 at nighttime .
-RESULTS	Our results revealed that moderately intense pain is associated with routine orthodontic treatment , and that the amount of pain individuals perceive varies widely .
-RESULTS	We observed statistically significant differences in the pain control among the three groups , and that etoricoxib 60mg proved most efficient .
-CONCLUSIONS	Etoricoxib 60mg is highly efficacious for controlling pain during fixed orthodontic appliance therapy .
-
-###24694667
-OBJECTIVE	The use of drug-eluting stents ( DES ) in patients with non-ST-segment elevation acute coronary syndrome ( NSTE-ACS ) is controversial and not yet endorsed in clinical guidelines .
-RESULTS	This was an a priori planned post hoc analysis involving 754 NSTE-ACS patients from the randomised BASKET-PROVE trial ( sirolimus-eluting stent vs. everolimus-eluting stent vs. bare metal stent in large-vessel stenting ) .
-RESULTS	The primary endpoint was the combined two-year rate of cardiovascular death or non-fatal myocardial infarction ( MI ) .
-RESULTS	Secondary endpoints were each component of the primary endpoint , and clinically indicated target vessel revascularisation ( TVR ) and stent thrombosis .
-RESULTS	Compared to patients with BMS , those treated with SES and EES had a strong trend towards lower two-year rates of the primary endpoint ( HR : 0.31 [ CI : 0.11-0 .90 ] , p = 0.03 , and HR : 0.74 [ CI : 0.44-1 .24 ] , p = 0.25 ) , and of TVR ( HR : 0.58 [ CI : 0.29-1 .15 ] , p = 0.12 ) and ( HR : 0.52 [ CI : 0.34-0 .78 ] , p = 0.002 ) .
-RESULTS	When the SES and EES groups were combined and compared to BMS , significant reductions in both cardiovascular death/MI and TVR were found .
-CONCLUSIONS	Compared with BMS , use of DES in NSTE-ACS patients undergoing stent implantation in large vessels was associated with a reduction in both TVR and the combined endpoint consisting of cardiovascular death/MI .
-CONCLUSIONS	Thus , DES use improves both efficacy and safety .
-CONCLUSIONS	These findings support the use of DES in NSTE-ACS patients .
-
-###24657991
-BACKGROUND	Data are limited on the implementation of evidence-based multilevel interventions targeted at blood pressure ( BP ) control in hypertensive blacks who receive care in low-resource primary care practices .
-RESULTS	Counseling African Americans to Control Hypertension is a cluster-randomized clinical trial in which 30 community health centers were randomly assigned to the intervention condition ( IC ) or usual care ( UC ) .
-RESULTS	Patients at the IC sites received patient education , home BP monitoring , and monthly lifestyle counseling , whereas physicians attended monthly hypertension case rounds and received feedback on their patients ' home BP readings and chart audits .
-RESULTS	Patients and physicians at the UC sites received printed patient education material and hypertension treatment guidelines , respectively .
-RESULTS	The primary outcome was BP control , and secondary outcomes were mean changes in systolic and diastolic BPs at 12 months , assessed with an automated BP device .
-RESULTS	A total of 1059 patients ( mean age , 56 years ; 28 % men , 59 % obese , and 36 % with diabetes mellitus ) were enrolled .
-RESULTS	The BP control rate was similar in both groups ( IC = 49.3 % versus UC = 44.5 % ; odds ratio , 1.21 [ 95 % confidence interval , 0.90-1 .63 ] ; P = 0.21 ) .
-RESULTS	In prespecified subgroup analyses , the intervention was associated with greater BP control in patients without diabetes mellitus ( IC = 54.0 % versus UC = 44.7 % ; odds ratio , 1.45 [ confidence interval , 1.02-2 .06 ] ) ; and small-sized community health centers ( IC = 51.1 % versus UC = 39.6 % ; odds ratio , 1.45 [ confidence interval , 1.04-2 .45 ] ) .
-CONCLUSIONS	A practice-based , multicomponent intervention was no better than UC in improving BP control among hypertensive blacks .
-CONCLUSIONS	Future research on the implementation of behavioral modification strategies for hypertension control in low-resource settings should focus on the development of more efficient and tailored interventions in this high-risk population .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00233220 .
-
-###24229729
-OBJECTIVE	The fast development of e-learning and social forums demands us to update our understanding of e-learning and peer learning .
-OBJECTIVE	We aimed to investigate if higher , pre-defined levels of e-learning or social interaction in web forums improved students ' learning ability .
-METHODS	One hundred and twenty Danish medical students were randomized to six groups all with 20 students ( eCases level 1 , eCases level 2 , eCases level 2 + , eTextbook level 1 , eTextbook level 2 , and eTextbook level 2 + ) .
-METHODS	All students participated in a pre-test , Group 1 participated in an interactive case-based e-learning program , while Group 2 was presented with textbook material electronically .
-METHODS	The 2 + groups were able to discuss the material between themselves in a web forum .
-METHODS	The subject was head injury and associated treatment and observation guidelines in the emergency room .
-METHODS	Following the e-learning , all students completed a post-test .
-METHODS	Pre - and post-tests both consisted of 25 questions randomly chosen from a pool of 50 different questions .
-RESULTS	All students concluded the study with comparable pre-test results .
-RESULTS	Students at Level 2 ( in both groups ) improved statistically significant compared to students at level 1 ( p > 0.05 ) .
-RESULTS	There was no statistically significant difference between level 2 and level 2 + .
-RESULTS	However , level 2 + was associated with statistically significant greater student 's satisfaction than the rest of the students ( p > 0.05 ) .
-CONCLUSIONS	This study applies a new way of comparing different types of e-learning using a pre-defined level division and the possibility of peer learning .
-CONCLUSIONS	Our findings show that higher levels of e-learning does in fact provide better results when compared with the same type of e-learning at lower levels .
-CONCLUSIONS	While social interaction in web forums increase student satisfaction , learning ability does not seem to change .
-CONCLUSIONS	Both findings are relevant when designing new e-learning materials .
-
-###26074395
-BACKGROUND	Switch maintenance is an effective strategy in the treatment of advanced Non-Small Cell Lung Cancer ( NSCLC ) .
-BACKGROUND	Pazopanib is an oral , multi-targeted tyrosine kinase inhibitor ( TKI ) .
-BACKGROUND	EORTC 08092 evaluated pazopanib given as maintenance treatment following standard first line platinum-based chemotherapy in patients with advanced NSCLC .
-METHODS	Patients with non-progressive disease after 4-6 cycles of chemotherapy were randomised to receive either pazopanib 800mg/day or matched placebo until progression or unacceptable toxicity .
-METHODS	The primary end-point was overall survival and secondary end-points were progression-free survival ( PFS ) and safety .
-RESULTS	A total of 600 patients were planned to be randomised .
-RESULTS	The trial was prematurely stopped following an early interim analysis , after 102 patients were randomised to pazopanib ( n = 50 ) or placebo ( n = 52 ) .
-RESULTS	Median age was 64years in both arms .
-RESULTS	Median overall survival was 17.4 months for pazopanib and 12.3 months for placebo ( adjusted hazard ratio ( HR ) 0.72 [ 95 % confidence interval ( CI ) 0.40-1 .28 ] ; p = 0.257 ) .
-RESULTS	Median PFS was 4.3 months versus 3.2 months ( HR 0.67 , [ 95 % CI 0.43-1 .03 ] , p = 0.068 ) .
-RESULTS	PFS rates at 4 months were 56 % and 45 % respectively .
-RESULTS	The majority of treatment-related adverse events ( AEs ) were grade 1-2 .
-RESULTS	Grade 3-4 AEs ( pazopanib versus placebo ) were hypertension ( 38 % versus 8 % ) , neutropenia ( 8 % versus 0 % ) , and elevated SGPT ( 6 % versus 0 % ) .
-RESULTS	Of the patients randomised to pazopanib , 22 % withdrew due to a treatment-related AE .
-CONCLUSIONS	Switch maintenance with pazopanib following platinum-based chemotherapy in advanced NSCLC patients had limited side-effects .
-CONCLUSIONS	This study was stopped due to lack of efficacy by stringent criteria for PFS at a futility interim analysis .
-
-###24769399
-BACKGROUND	Conventional food production commonly uses organophosphate ( OP ) pesticides , which can have negative health effects , while organic food is deemed healthier because it is produced without these pesticides .
-BACKGROUND	Studies suggest that organic food consumption may significantly reduce OP pesticide exposure in children who have relatively higher pesticide exposure than adults due to their different diets , body weight , behaviour and less efficient metabolism .
-OBJECTIVE	A prospective , randomised , crossover study was conducted to determine if an organic food diet reduces organophosphate exposure in adults .
-METHODS	Thirteen participants were randomly allocated to consume a diet of at least 80 % organic or conventional food for 7 days and then crossed over to the alternate diet .
-METHODS	Urinary levels of six dialkylphosphate metabolites were analysed in first-morning voids collected on day 8 of each phase using GC-MS/MS with detection limits of 0.11-0 .51 g/L .
-RESULTS	The mean total DAP results in the organic phase were 89 % lower than in the conventional phase ( M = 0.032 [ SD = 0.038 ] and 0.294 [ SD = 0.435 ] respectively , p = 0.013 ) .
-RESULTS	For total dimethyl DAPs there was a 96 % reduction ( M = 0.011 [ SD = 0.023 ] and 0.252 [ SD = 0.403 ] respectively , p = 0.005 ) .
-RESULTS	Mean total diethyl DAP levels in the organic phase were half those of the conventional phase ( M = 0.021 [ SD = 0.020 ] and 0.042 [ SD = 0.038 ] respectively ) , yet the wide variability and small sample size meant the difference was not statistically significant .
-CONCLUSIONS	The consumption of an organic diet for one week significantly reduced OP pesticide exposure in adults .
-CONCLUSIONS	Larger scale studies in different populations are required to confirm these findings and investigate their clinical relevance .
-
-###25595580
-OBJECTIVE	Postpartum infections are polymicrobial and typically include Ureaplasma , an intracellular microbe that is treated by macrolides such as azithromycin .
-OBJECTIVE	The aim of this study was to evaluate the perinatal pharmacokinetics of azithromycin after a single preincision dose before cesarean delivery .
-METHODS	Thirty women who underwent scheduled cesarean delivery were assigned randomly to receive 500 mg of intravenous azithromycin that was initiated 15 , 30 , or 60 minutes before incision and infused over 1 hour .
-METHODS	Serial maternal plasma samples were drawn from the end of infusion up to 8 hours after the infusion .
-METHODS	Samples of amniotic fluid , umbilical cord blood , placenta , myometrium , and adipose tissue were collected intraoperatively .
-METHODS	Breast milk samples were collected 12-48 hours after the infusion in 8 women who were breastfeeding .
-METHODS	Azithromycin was quantified with high performance liquid chromatography separation coupled with tandem mass spectrometry detection .
-METHODS	Plasma pharmacokinetic parameters were estimated with the use of noncompartmental analysis and compartmental modeling and simulations .
-RESULTS	The maximum maternal plasma concentration was reached within 1 hour and exceeded the in vitro minimum inhibitory concentration ( MIC50 ) of 250 ng/mL of Ureaplasma spp in all 30 patients .
-RESULTS	The concentrations were sustained with a half-life of 6.7 hours .
-RESULTS	The median concentration of azithromycin in adipose tissue was 102 ng/g , which was below the MIC50 .
-RESULTS	The median concentration in myometrium was 402 ng/g , which exceeded the MIC50 .
-RESULTS	Azithromycin was detectable in both the umbilical cord plasma and amniotic fluid after the single preoperative dose .
-RESULTS	Azithromycin concentrations in breast milk were high and were sustained up to 48 hours after the single dose .
-RESULTS	Simulations demonstrated accumulation in breast milk after multiple doses .
-CONCLUSIONS	A single dose of azithromycin achieves effective plasma and tissue concentrations and is transported rapidly across the placenta .
-CONCLUSIONS	The tissue concentrations that are achieved in the myometrium exceed the MIC50 for Ureaplasma spp .
-
-###25624376
-OBJECTIVE	To determine the immunologic effects of oropharyngeal colostrum administration in extremely premature infants .
-METHODS	We conducted a double-blind , randomized , placebo-controlled trial involving 48 preterm infants born before 28 weeks ' gestation .
-METHODS	Subjects received 0.2 mL of their mother 's colostrum or sterile water via oropharyngeal route every 3 hours for 3 days beginning at 48 to 96 hours of life .
-METHODS	To measure concentrations of secretory immunoglobulin A , lactoferrin , and several immune substances , urine and saliva were obtained during the first 24 hours of life and at 8 and 15 days .
-METHODS	Clinical data during hospitalization were collected .
-RESULTS	Urinary levels of secretory immunoglobulin A at 1 week ( 71.4 vs 26.5 ng/g creatinine , P = .04 ) and 2 weeks ( 233.8 vs 48.3 ng/g creatinine , P = .006 ) , and lactoferrin at 1 week ( 3.5 vs 0.9 g/g creatinine , P = .01 ) were significantly higher in colostrum group .
-RESULTS	Urine interleukin-1 level was significantly lower in colostrum group at 2 weeks ( 55.3 vs 91.8 g/g creatinine , P = .01 ) .
-RESULTS	Salivary transforming growth factor-1 ( 39.2 vs 69.7 g/mL , P = .03 ) and interleukin-8 ( 1.2 vs 4.9 ng/mL , P = .04 ) were significantly lower at 2 weeks in colostrum group .
-RESULTS	A significant reduction in the incidence of clinical sepsis was noted in colostrum group ( 50 % vs 92 % , P = .003 ) .
-CONCLUSIONS	This study suggests that oropharyngeal administration of colostrum may decrease clinical sepsis , inhibit secretion of pro-inflammatory cytokines , and increase levels of circulating immune-protective factors in extremely premature infants .
-CONCLUSIONS	Larger studies to confirm these findings are warranted .
-
-###25405392
-BACKGROUND	Aortic-root dissection is the leading cause of death in Marfan 's syndrome .
-BACKGROUND	Studies suggest that with regard to slowing aortic-root enlargement , losartan may be more effective than beta-blockers , the current standard therapy in most centers .
-METHODS	We conducted a randomized trial comparing losartan with atenolol in children and young adults with Marfan 's syndrome .
-METHODS	The primary outcome was the rate of aortic-root enlargement , expressed as the change in the maximum aortic-root-diameter z score indexed to body-surface area ( hereafter , aortic-root z score ) over a 3-year period .
-METHODS	Secondary outcomes included the rate of change in the absolute diameter of the aortic root ; the rate of change in aortic regurgitation ; the time to aortic dissection , aortic-root surgery , or death ; somatic growth ; and the incidence of adverse events .
-RESULTS	From January 2007 through February 2011 , a total of 21 clinical centers enrolled 608 participants , 6 months to 25 years of age ( mean [ SD ] age , 11.56.5 years in the atenolol group and 11.06.2 years in the losartan group ) , who had an aortic-root z score greater than 3.0 .
-RESULTS	The baseline-adjusted rate of change in the mean ( SE ) aortic-root z score did not differ significantly between the atenolol group and the losartan group ( -0.1390.013 and -0.1070.013 standard-deviation units per year , respectively ; P = 0.08 ) .
-RESULTS	Both slopes were significantly less than zero , indicating a decrease in the aortic-root diameter relative to body-surface area with either treatment .
-RESULTS	The 3-year rates of aortic-root surgery , aortic dissection , death , and a composite of these events did not differ significantly between the two treatment groups .
-CONCLUSIONS	Among children and young adults with Marfan 's syndrome who were randomly assigned to losartan or atenolol , we found no significant difference in the rate of aortic-root dilatation between the two treatment groups over a 3-year period .
-CONCLUSIONS	( Funded by the National Heart , Lung , and Blood Institute and others ; ClinicalTrials.gov number , NCT00429364 . )
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-###25002717
-OBJECTIVE	To investigate the efficacy and safety of aerobic training ( AT ) in patients with cancer with medically stable heart failure ( HF ) .
-METHODS	A retrospective analysis of 90 patients with cancer who have HF and who were randomly assigned to AT ( n = 47 ) or guideline-based usual care ( UC ; n = 43 ) was performed .
-METHODS	AT consisted of three supervised sessions per week at 20 to 45 minutes per session at 60 % to 70 % of heart rate reserve for 12 weeks followed by home-based sessions for 4 to 12 months .
-METHODS	The primary end point was all-cause mortality and hospitalization .
-METHODS	Secondary end points were other clinical events , safety , and change in exercise capacity ( VO ( 2peak ) ) and health-related quality of life ( HRQOL ) .
-RESULTS	Median follow-up was 35 months .
-RESULTS	In intention-to-treat ( ITT ) analyses , all-cause mortality or hospitalization at 2 years was 74 % in the AT group compared with 67 % in the UC group ( adjusted hazard ratio [ HR ] , 1.11 ; 95 % CI , 0.69 to 1.77 ; P = .676 ) .
-RESULTS	The incidence of cardiovascular mortality or cardiovascular hospitalization was significantly higher in the AT group compared with the UC group ( 41 % v 67 % ; adjusted HR , 1.94 ; 95 % CI , 1.12 to 3.16 ; P = .017 ) .
-RESULTS	There were no differences in any VO ( 2peak ) or HRQOL end points .
-RESULTS	In post hoc analyses based on adherence to AT , all-cause mortality and hospitalization was 66 % in adherent patients ( 90 minutes per week ) compared with 84 % in nonadherent patients ( < 90 minutes per week ) .
-CONCLUSIONS	In ITT analyses , AT did not improve clinical outcomes in patients with cancer who had HF .
-CONCLUSIONS	Post hoc analyses suggested that patients not capable of adhering to the planned AT prescription may be at increased risk of clinical events .
-
-###24944260
-OBJECTIVE	To determine whether droxidopa , an oral norepinephrine precursor , improves symptomatic neurogenic orthostatic hypotension ( nOH ) .
-METHODS	Patients with symptomatic nOH due to Parkinson disease , multiple system atrophy , pure autonomic failure , or nondiabetic autonomic neuropathy underwent open-label droxidopa dose optimization ( 100-600 mg 3 times daily ) , followed , in responders , by 7-day washout and then a 7-day double-blind trial of droxidopa vs placebo .
-METHODS	Outcome measures included patient self-ratings on the Orthostatic Hypotension Questionnaire ( OHQ ) , a validated , nOH-specific tool that assesses symptom severity and symptom impact on daily activities .
-RESULTS	From randomization to endpoint ( n = 162 ) , improvement in mean OHQ composite score favored droxidopa over placebo by 0.90 units ( p = 0.003 ) .
-RESULTS	Improvement in OHQ symptom subscore favored droxidopa by 0.73 units ( p = 0.010 ) , with maximum change in `` dizziness/lightheadedness . ''
-RESULTS	Improvement in symptom-impact subscore favored droxidopa by 1.06 units ( p = 0.003 ) , with maximum change for `` standing a long time . ''
-RESULTS	Mean standing systolic blood pressure ( BP ) increased by 11.2 vs 3.9 mm Hg ( p < 0.001 ) , and mean supine systolic BP by 7.6 vs 0.8 mm Hg ( p < 0.001 ) .
-RESULTS	At endpoint , supine systolic BP > 180 mm Hg was observed in 4.9 % of droxidopa and 2.5 % of placebo recipients .
-RESULTS	Adverse events reported in 3 % of double-blind droxidopa recipients were headache ( 7.4 % ) and dizziness ( 3.7 % ) .
-RESULTS	No patients discontinued double-blind treatment because of adverse events .
-CONCLUSIONS	In patients with symptomatic nOH , droxidopa improved symptoms and symptom impact on daily activities , with an associated increase in standing systolic BP , and was generally well tolerated .
-METHODS	This study provides Class I evidence that in patients with symptomatic nOH who respond to open-label droxidopa , droxidopa improves subjective and objective manifestation of nOH at 7 days .
-
-###24613655
-OBJECTIVE	Midazolam comedication with morphine is a routine practice in pre and postoperative patients but has not been evaluated in prehospital setting .
-OBJECTIVE	We aimed to evaluate the comedication effect of midazolam in the prehospital traumatic adults .
-METHODS	A prehospital prospective randomized double-blind placebo-controlled trial of intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg vs morphine 0.10 mg/kg and placebo .
-METHODS	Pain assessment was done using a validated numeric rating scale ( NRS ) .
-METHODS	The primary end point was to achieve an efficient analgesic effect ( NRS3 ) 20 minutes after the baseline .
-METHODS	The secondary end points were treatment safety , total morphine dose required until obtaining NRS3 , and efficient analgesic effect 30 minutes after the baseline .
-RESULTS	Ninety-one patients were randomized into midazolam ( n = 41 ) and placebo ( n = 50 ) groups .
-RESULTS	No significant difference in proportion of patients with a pain score3 was observed between midazolam ( 43.6 % ) and placebo ( 45.7 % ) after 20 minutes ( P = .849 ) .
-RESULTS	Secondary end points were similar in regard with proportion of patients with a pain score3 at T30 , the side effects and adverse events except for drowsiness in midazolam vs placebo , 43.6 % vs 6.5 % ( P < .001 ) .
-RESULTS	No significant difference in total morphine dose was observed , that is , midazolam ( 14.09 mg6 .64 ) vs placebo ( 15.53 mg6 .27 ) ( P = .315 ) .
-CONCLUSIONS	According to our study , midazolam does not enhance pain control as an adjunctive to morphine regimen in the management of trauma-induced pain in prehospital setting .
-CONCLUSIONS	However , such midazolam use seems to be associated with an increase in drowsiness .
-
-###24938492
-BACKGROUND	Recent initiatives to target the personal , social and clinical needs of people with long-term health conditions have had limited impact within primary care .
-BACKGROUND	Evidence of the importance of social networks to support people with long-term conditions points to the need for self-management approaches which align personal circumstances with valued activities .
-BACKGROUND	The Patient-Led Assessment for Network Support ( PLANS ) intervention is a needs-led assessment for patients to prioritise their health and social needs and provide access to local community services and activities .
-BACKGROUND	Exploring the work and practices of patients and telephone workers are important for understanding and evaluating the workability and implementation of new interventions .
-METHODS	Qualitative methods ( interviews , focus group , observations ) were used to explore the experience of PLANS from the perspectives of participants and the telephone support workers who delivered it ( as part of an RCT ) and the reasons why the intervention worked or not .
-METHODS	Normalisation Process Theory ( NPT ) was used as a sensitising tool to evaluate : the relevance of PLANS to patients ( coherence ) ; the processes of engagement ( cognitive participation ) ; the work done for PLANS to happen ( collective action ) ; the perceived benefits and costs of PLANS ( reflexive monitoring ) .
-METHODS	20 patients in the intervention arm of a clinical trial were interviewed and their telephone support calls were recorded and a focus group with 3 telephone support workers was conducted .
-RESULTS	Analysis of the interviews , support calls and focus group identified three themes in relation to the delivery and experience of PLANS .
-RESULTS	These are : formulation of ` health ' in the context of everyday life ; trajectories and tipping points : disrupting everyday routines ; precarious trust in networks .
-RESULTS	The relevance of these themes are considered using NPT constructs in terms of the work that is entailed in engaging with PLANS , taking action , and who is implicated this process .
-CONCLUSIONS	PLANS gives scope to align long-term condition management to everyday life priorities and valued aspects of life .
-CONCLUSIONS	This approach can improve engagement with health-relevant practices by situating them within everyday contexts .
-CONCLUSIONS	This has potential to increase utilisation of local resources with potential cost-saving benefits for the NHS .
-BACKGROUND	ISRCTN45433299 .
-
-###24827469
-OBJECTIVE	To evaluate the effect of acupuncture on hot flushes and other menopause-related symptoms used in an integrated system , including such therapeutic techniques as diet therapy and Tuina self-massage .
-METHODS	Randomized trial .
-METHODS	Outpatient center .
-METHODS	One hundred women in spontaneous menopause with at least three episodes of hot flushes daily were randomly allocated to two treatment groups ( 50 per group ) : Women in group A were given diet , self-massage training , and treatment with acupuncture , and women in group B ( the control group ) were given the same diet and self-massage training , but treatment with acupuncture started 6 weeks after they were enrolled into the study .
-METHODS	Acupuncture treatments were scheduled twice weekly for 6 consecutive weeks .
-METHODS	Mean change in frequency and/or intensity in menopause-related symptoms were estimated by questionnaire after treatment at week 4 .
-RESULTS	Treatment with acupuncture significantly reduced the occurrence of hot flushes and sudden sweating ( p < .001 ) .
-RESULTS	Other symptoms ( sleep disorders , tightness in the chest , irritability , bone pain , feeling depressed ) significantly improved .
-CONCLUSIONS	Acupuncture in an integrated system that includes therapeutic techniques such as diet therapy and Tuina self-massage can be used to treat hot flushes and selected symptoms in postmenopausal women .
-
-###24700254
-OBJECTIVE	Although social anxiety disorder is a common and sometimes disabling condition , there are no approved treatments that can be used on an as-needed basis .
-OBJECTIVE	The authors examined the acute use of PH94B , an intranasally administered neurosteroidal aerosol , for the acute management of the symptoms of social anxiety disorder .
-METHODS	The authors conducted a phase 2 , multicenter , randomized , double-blind , placebo-controlled , single-dose study of PH94B .
-METHODS	Ninety-one women 19-60 years of age with generalized social anxiety disorder received placebo intranasal spray ( single-blind ) 15 minutes before laboratory-simulated public speaking and social interaction challenges .
-METHODS	Patients who experienced significant distress during at least one challenge returned 1 week later to receive either intranasal PH94B or placebo aerosol spray ( double-blind ) before repeat challenges .
-RESULTS	Patients who received PH94B during the second set of challenges had a significantly greater decrease in mean Subjective Units of Distress scores during the public speaking and social interaction challenges compared with the first set of challenges , than did patients who received placebo for both sets of challenges .
-RESULTS	A significantly greater proportion of the PH94B group were much or very much improved from the first to the second sets of challenges compared with the placebo group ( 75 % and 37 % , respectively ) .
-RESULTS	The side effects of PH94B were benign .
-CONCLUSIONS	PH94B may be a novel , effective , and well-tolerated acute treatment for performance and social anxiety in women with social anxiety disorder .
-
-###24622423
-BACKGROUND	Autologous chondrocyte implantation ( ACI ) aims to restore hyaline cartilage .
-BACKGROUND	Traditionally , ACI rehabilitation is prescribed in a concurrent ( CON ) format .
-BACKGROUND	However , it is well known from studies in asymptomatic populations that CON training produces an interference effect that can attenuate strength gains .
-BACKGROUND	Strength is integral to joint function , so adopting a nonconcurrent ( N-CON ) approach to ACI rehabilitation might improve outcomes .
-OBJECTIVE	To assess changes in function and neuromuscular performance during 48 wk of CON and N-CON physical rehabilitation after ACI to the knee .
-METHODS	Orthopedic Hospital NHS Foundation Trust .
-METHODS	Randomized control , pilot study .
-METHODS	11 patients ( 9 male , 2 female ; age 32.3 6.6 y ; body mass 79.3 10.4 kg ; time from injury to surgery 7.1 4.9 mo [ mean SD ] ) randomly allocated to N-CON : CON ( 2:1 ) .
-METHODS	Standardized CON and N-CON physiotherapy that involved separation of strength and cardiovascular-endurance conditioning .
-METHODS	Function in the single-leg-hop test , patient-reported outcomes ( Knee injury and Osteoarthritis Outcome Score [ KOOS ] , International Knee Documentation Committee subjective questionnaire [ IKDC ] ) , and neuromuscular outcomes of peak force ( PF ) , rate of force development ( RFD ) , electromechanical delay ( EMD ) , and sensorimotor performance ( force error [ FE ] ) of the knee extensors and flexors of the injured and noninjured legs , measured presurgery and at 6 , 12 , 24 , and 48 wk postsurgery .
-RESULTS	Factorial ANOVAs with repeated measures of group by leg and by test occasion revealed significantly superior improvements for KOOS , IKDC , PF , EMD , and FE associated with N-CON vs. CON rehabilitation ( F ( 1.5,13.4 GG ) = 3.7-4 .7 , P < .05 ) .
-RESULTS	These results confirm increased peak effectiveness of N-CON rehabilitation ( ~ 4.5-13 .3 % better than CON over 48 wk of rehabilitation ) .
-RESULTS	N-CON and CON showed similar patterns of improvement for single-leg-hop test and RFD .
-CONCLUSIONS	Nonconcurrent strength and cardiovascular-endurance conditioning during 48 wk of rehabilitation after ACI surgery elicited significantly greater improvements to functional and neuromuscular outcomes than did contemporary concurrent rehabilitation .
-
-###25078052
-BACKGROUND	Study objective To assess the efficacy of outpatient misoprostol administration versus inpatient misoprostol administration for the treatment of first trimester incomplete miscarriage .
-METHODS	A prospective randomised controlled trial was conducted at a tertiary hospital from May 2012 to April 2013 .
-METHODS	A total of 154 patients with first trimester incomplete miscarriage were randomised to receive misoprostol either as outpatient or inpatient .
-METHODS	Intra-vaginal misoprostol 800 mcg was administered eight hourly to a maximum of three doses .
-METHODS	Complete evacuation is achieved when the cervical os was closed on vaginal examination or ultrasound showed no more retained products of conception evidenced by endometrial thickness of less than 15 mm .
-METHODS	Treatment failure was defined as failure in achieving complete evacuation on day seven hence surgical evacuation is offered .
-RESULTS	Outpatient administration of misoprostol was as effective as inpatient treatment with success rate of 89.2 and 85.7 % ( p = 0.520 ) .
-RESULTS	The side effects were not significantly different between the two groups .
-RESULTS	Side effects that occurred were minor and only required symptomatic treatment .
-RESULTS	Duration of bleeding was 6.0 days in both groups ( p = 0.317 ) .
-RESULTS	Mean reduction in haemoglobin was lesser in the outpatient group ( 0.4 g/dl ) as compared to in the inpatient group ( 0.6 g/dl ) which was statistically significant ( p = 0.048 ) .
-CONCLUSIONS	Medical evacuation using intra-vaginal misoprostol 800 mcg eight hourly for a maximum of three doses in an outpatient setting is as effective as in inpatient setting with tolerable side effects .
-
-###24689255
-OBJECTIVE	The authors examine the pattern of direction errors made during the manipulation of a physical simulation of an underground coal mine bolting machine to assess the directional control-response compatibility relationships associated with the device and to compare these results to data obtained from a virtual simulation of a generic device .
-BACKGROUND	Directional errors during the manual control of underground coal roof bolting equipment are associated with serious injuries .
-BACKGROUND	Directional control-response relationships have previously been examined using a virtual simulation of a generic device ; however , the applicability of these results to a specific physical device may be questioned .
-METHODS	Forty-eight participants randomly assigned to different directional control-response relationships manipulated horizontal or vertical control levers to move a simulated bolter arm in three directions ( elevation , slew , and sump ) as well as to cause a light to become illuminated and raise or lower a stabilizing jack .
-METHODS	Directional errors were recorded during the completion of 240 trials by each participant
-RESULTS	Directional error rates are increased when the control and response are in opposite directions or if the direction of the control and response are perpendicular.The pattern of direction error rates was consistent with experiments obtained from a generic device in a virtual environment .
-CONCLUSIONS	Error rates are increased by incompatible directional control-response relationships .
-CONCLUSIONS	Ensuring that the design of equipment controls maintains compatible directional control-response relationships has potential to reduce the errors made in high-risk situations , such as underground coal mining .
-
-###24864465
-OBJECTIVE	To evaluate the impact of 10-14-day intravenous administration of meldonium as part of combination therapy in patients with chronic heart failure in the early post-infarction period on the recovery period , structural and functional parameters , and heart rate variability ( HRV ) .
-METHODS	The investigation enrolled 60 patients ( men and women ) aged 45 to 75 years at weeks 3-4 after post-myocardial infarction with symptoms of Functional Class II-III heart failure .
-METHODS	All the patients underwent 24-hour electrochocardiography monitoring , cardiac echocardiography , and HRV study .
-METHODS	After dividing the patients into 2 groups , Group 1 ( a study group ) ( n = 30 ) was given intravenous meldonium ( idrinol ) 1000 mg/day in addition to the basic therapy of coronary heart disease .
-METHODS	The patients in the study and control ( Group 2 ; n = 30 ) groups were at baseline matched for age , gender , disease severity , and basic therapy pattern .
-RESULTS	Following 10-14 days of treatment , both groups showed clinical improvement and the favorable changes in cardiac structural and functional parameters and HRV values , which were more pronounced in the patients receiving meldonium .
-CONCLUSIONS	The patients with CHF using meldonium as part of combination therapy in the early post-infarction period were observed to have clinical improvement , a significant reduction in the rate of angina attacks and in the need for nitrates , a decrease in the number of arrhythmic and ischemic episodes , and favorable changes in cardiac structural and functional parameters and HRV values .
-
-###25406436
-OBJECTIVE	This article illustrates the use of mixed methods in the development and evaluation of the Positive Online Weight Reduction ( POWeR ) programme , an e-health intervention designed to support sustainable weight loss .
-OBJECTIVE	The studies outlined also explore how human support might enhance intervention usage and weight loss .
-METHODS	Mixed methods were used to develop and evaluate POWeR .
-METHODS	In the development phase , we drew on both quantitative and qualitative findings to plan and gain feedback on the intervention .
-METHODS	Next , a feasibility trial , with nested qualitative study , explored what level of human support might lead to the most sustainable weight loss .
-METHODS	Finally , a large community-based trial of POWeR , with nested qualitative study , explored whether the addition of brief telephone coaching enhances usage .
-RESULTS	Findings suggest that POWeR is acceptable and potentially effective .
-RESULTS	Providing human support enhanced usage in our trials , but was not unproblematic .
-RESULTS	Interestingly , there were some indications that more basic ( brief ) human support may produce more sustainable weight loss outcomes than more regular support .
-RESULTS	Qualitative interviews suggested that more regular support might foster reliance , meaning patients can not sustain their weight losses when support ends .
-RESULTS	Qualitative findings in the community trial also suggested explanations for why many people may not take up the opportunity for human support .
-CONCLUSIONS	Integrating findings from both our qualitative and quantitative studies provided far richer insights than would have been gained using only a single method of inquiry .
-CONCLUSIONS	Further research should investigate the optimum delivery of human support needed to maximize sustainable weight loss in online interventions .
-CONCLUSIONS	Statement of contribution What is already known on this subject ?
-CONCLUSIONS	There is evidence that human support may increase the effectiveness of e-health interventions .
-CONCLUSIONS	It is unclear what level of human support might be optimal or how human support improves effectiveness .
-CONCLUSIONS	Triangulation of quantitative and qualitative methods can be used to inform the design and implementation of interventions What does this study add ?
-CONCLUSIONS	This paper demonstrates the value of a mixed methods approach when developing and evaluating an intervention .
-CONCLUSIONS	Qualitative methods provided complementary insights into the optimal level of human support .
-CONCLUSIONS	Brief human support is valued by some and may enhance usage and outcomes of an e-health intervention for weight loss .
-
-###25542910
-OBJECTIVE	This study assessed whether the Venner-PneuX endotracheal tube ( ET ) system , which has sub-glottic suction as well as irrigation ports and continuous cuff-pressure monitoring , is associated with a reduction in ventilator-associated pneumonia ( VAP ) when compared with the standard ET in high-risk patients undergoing cardiac surgery .
-METHODS	This was a single-institution , prospective , randomized control trial .
-METHODS	Patients were categorized as either Group A ( Venner-PneuX ET tube , n = 120 ) or Group B ( Standard ET tube , n = 120 ) .
-METHODS	Inclusion criteria included patients over the age of 70 years and/or impaired left ventricular function ( LVEF < 50 % ) undergoing cardiac surgery .
-METHODS	Patients were monitored for VAP for up to 48 h post extubation and the diagnosis of VAP was according to the centres for disease control definition .
-RESULTS	There were no significant differences in the patients ' demographics .
-RESULTS	The mean ( SD ) ages for the two groups were 72.4 ( 8.2 ) and 72.1 ( 7.4 ) years ( P = 0.6 ) , respectively .
-RESULTS	The mean EuroSCORE was 6.39 ( 2.2 ) for Group A and 6.48 ( 2.6 ) for Group B ( P = 0.9 ) .
-RESULTS	The median intubation times were 14.7 ( 7.3 , 2927.2 ) h and 13 ( 2.5 , 528.7 ) h , respectively .
-RESULTS	VAP incidence was significantly lower in the Venner-PneuX ET group , being 10.8 % when compared with 21 % in the standard ET group ( P = 0.03 ) .
-RESULTS	There was no significant difference between the two groups in terms of intensive care unit stay ( P = 0.2 ) and in-hospital mortality ( P = 0.2 ) .
-RESULTS	A binary logistic regression analysis ( type of ET tube , age , LVEF , history of lung disease , smoking history , surgical procedure , EuroSCORE , cardiopulmonary bypass time , blood transfusion , intubation duration among others ) confirmed that the Venner-PneuX ET tube was associated with significant VAP reduction ( Odds ratio 0.45 , P = 0.03 ) .
-CONCLUSIONS	The Venner-PneuX VAP prevention system is associated with a significant reduction in VAP .
-CONCLUSIONS	This can potentially lead to significant cost reductions and should be implemented as part of the VAP reduction bundle .
-
-###26053341
-OBJECTIVE	Treatment of respiratory distress syndrome in premature infants with continuous positive airway pressure ( CPAP ) preserves surfactant and keeps the lung open but is insufficient in severe surfactant deficiency .
-OBJECTIVE	Traditional surfactant administration is related to short periods of positive pressure ventilation and implies the risk of lung injury .
-OBJECTIVE	CPAP with surfactant but without any positive pressure ventilation may work synergistically .
-OBJECTIVE	This randomized trial investigated a less invasive surfactant application protocol ( LISA ) .
-OBJECTIVE	To test the hypothesis that LISA increases survival without bronchopulmonary dysplasia ( BPD ) at 36 weeks ' gestational age in extremely preterm infants .
-METHODS	The Nonintubated Surfactant Application trial was a multicenter , randomized , clinical , parallel-group study conducted between April 15 , 2009 , and March 25 , 2012 , in 13 level III neonatal intensive care units in Germany .
-METHODS	The final follow-up date was June 21 , 2012 .
-METHODS	Participants included 211 of 558 eligible ( 37.8 % ) spontaneously breathing preterm infants born between 23.0 and 26.8 weeks ' gestational age with signs of respiratory distress syndrome .
-METHODS	In an intention-to-treat design , infants were randomly assigned to receive surfactant either via a thin endotracheal catheter during CPAP-assisted spontaneous breathing ( intervention group ) or after conventional endotracheal intubation during mechanical ventilation ( control group ) .
-METHODS	Analysis was conducted from September 6 , 2012 , to June 20 , 2013 .
-METHODS	LISA via a thin catheter .
-METHODS	Survival without BPD at 36 weeks ' gestational age .
-RESULTS	Of 211 infants who were randomized , 104 were randomized to the control group and 107 to the LISA group .
-RESULTS	Of the infants who received LISA , 72 ( 67.3 % ) survived without BPD compared with 61 ( 58.7 % ) of those in the control group .
-RESULTS	The reduction in absolute risk was 8.6 % ( 95 % CI , -5.0 % to 21.9 % ; P = .20 ) .
-RESULTS	Intervention group infants were less frequently intubated ( 80 infants [ 74.8 % ] vs 103 [ 99.0 % ] ; P < .001 ) and required fewer days of mechanical ventilation .
-RESULTS	Significant reductions were seen in pneumothorax ( 5 of 105 intervention group infants [ 4.8 % ] vs 13 of 103 12.6 % ] ; P = .04 ) and severe intraventricular hemorrhage ( 11 infants [ 10.3 % ] vs 23 [ 22.1 % ] ; P = .02 ) , and the combined survival without severe adverse events was increased in the intervention group ( 54 infants [ 50.5 % ] vs 37 [ 35.6 % ] ; P = .02 ; absolute risk reduction , 14.9 ; 95 % CI , 1.4 to 28.2 ) .
-CONCLUSIONS	LISA did not increase survival without BPD but was associated with increased survival without major complications .
-CONCLUSIONS	Because major complications are related to lifelong disabilities , LISA may be a promising therapy for extremely preterm infants .
-BACKGROUND	isrctn.org Identifier : ISRCTN64011614 .
-
-###25409454
-BACKGROUND	Alcohol misuse in England costs around 7.3 billion ( US$ 12.2 billion ) annually from lost productivity and absenteeism .
-BACKGROUND	Delivering brief alcohol interventions to employees as part of a health check may be acceptable , particularly with online delivery which can provide privacy for this stigmatised behaviour .
-BACKGROUND	Research to support this approach is limited and methodologically weak .
-BACKGROUND	The aim was to determine the effectiveness of online screening and personalised feedback on alcohol consumption , delivered in a workplace as part of a health check .
-RESULTS	This two-group online individually randomised controlled trial recruited employees from a UK-based private sector organisation ( approx .
-RESULTS	100,000 employees ) .
-RESULTS	3,375 employees completed the online health check in the three week recruitment period .
-RESULTS	Of these , 1,330 ( 39 % ) scored five or more on the AUDIT-C ( indicating alcohol misuse ) and were randomised to receive personalised feedback on their alcohol intake , alongside feedback on other health behaviours ( n = 659 ) , or to receive feedback on all health behaviours except alcohol intake ( n = 671 ) .
-RESULTS	Participants were mostly male ( 75 % ) , with a median age of 48 years and half were in managerial positions ( 55 % ) .
-RESULTS	Median Body Mass Index was 26 , 12 % were smokers , median time undertaking moderate/vigorous physical activity a week was 173 minutes and median fruit and vegetable consumption was three portions a day .
-RESULTS	Eighty percent ( n = 1,066 ) of participants completed follow-up questionnaires at three months .
-RESULTS	An intention to treat analysis found no difference between experimental groups for past week drinking ( primary outcome ) ( 5.6 % increase associated with the intervention ( 95 % CI -4.7 % to 16.9 % ; p = .30 ) ) , AUDIT ( measure of alcohol-related harm ) and health utility ( EQ-5D ) .
-CONCLUSIONS	There was no evidence to support the use of personalised feedback within an online health check for reducing alcohol consumption among employees in this organisation .
-CONCLUSIONS	Further research is needed on how to engage a larger proportion of employees in screening .
-BACKGROUND	International Standard Randomised Controlled Trial Number Register ISRCTN50658915 .
-
-###24777114
-BACKGROUND	The purposes of this study were to compare the oxygen cost , metabolic parameters and temporalspatial variables between barefoot and shod running in trained mid-forefoot runners .
-METHODS	Experienced runners ( N. = 21 ; 3010.9 years ; 16 men ) performed two separate 20 minute treadmill running bouts at ~ 77 % of estimated maximal heart rate .
-METHODS	Rate of oxygen consumption ( VO2 ) , energy cost , fuel use and heart rate ( HR ) were collected continuously using a portable gas analyzer .
-METHODS	Three-dimensional motion capture was used to measure temporalspatial parameters .
-RESULTS	Participants ran at a mean self-selected speed of 3.10.3 m/s for both conditions , at intensities corresponding to mean HR values of 146 bpm ( shod ) and 144 bpm ( barefoot ) .
-RESULTS	Steady State VO2 was not different between the shod and barefoot conditions ( 39.4 4.7 mL/kg * min vs. 405.2 mL/kg * min , respectively ) .
-RESULTS	The total energy expended in the shod and barefoot conditions was 974134 kJ and 979142 kJ .
-RESULTS	The average non-protein respiratory exchange ratios , proportions and amount of fat and carbohydrate used were not different between conditions .
-RESULTS	Cadence was 2.5 % higher and center of gravity vertical displacement was 0.5 cm less for the barefoot condition ( P < 0.05 ) .
-CONCLUSIONS	In trained mid-forefoot runners experienced with barefoot running , there are not significant metabolic differences between shod and barefoot running conditions .
-CONCLUSIONS	Barefoot running increases cadence and decreases foot contact time and vertical displacement .
-CONCLUSIONS	Experienced participants were likely able to titrate kinematics to standardize energy output and fuel use for a given running distance and speed irrespective of shoe wear .
-
-###25608756
-BACKGROUND	Clinical trials yielded conflicting data about the benefit of adding systemic corticosteroids for treatment of community-acquired pneumonia .
-BACKGROUND	We assessed whether short-term corticosteroid treatment reduces time to clinical stability in patients admitted to hospital for community-acquired pneumonia .
-METHODS	In this double-blind , multicentre , randomised , placebo-controlled trial , we recruited patients aged 18 years or older with community-acquired pneumonia from seven tertiary care hospitals in Switzerland within 24 h of presentation .
-METHODS	Patients were randomly assigned ( 1:1 ratio ) to receive either prednisone 50 mg daily for 7 days or placebo .
-METHODS	The computer-generated randomisation was done with variable block sizes of four to six and stratified by study centre .
-METHODS	The primary endpoint was time to clinical stability defined as time ( days ) until stable vital signs for at least 24 h , and analysed by intention to treat .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT00973154 .
-RESULTS	From Dec 1 , 2009 , to May 21 , 2014 , of 2911 patients assessed for eligibility , 785 patients were randomly assigned to either the prednisone group ( n = 392 ) or the placebo group ( n = 393 ) .
-RESULTS	Median time to clinical stability was shorter in the prednisone group ( 30 days , IQR 25-34 ) than in the placebo group ( 44 days , 40-50 ; hazard ratio [ HR ] 133 , 95 % CI 115-150 , p < 00001 ) .
-RESULTS	Pneumonia-associated complications until day 30 did not differ between groups ( 11 [ 3 % ] in the prednisone group and 22 [ 6 % ] in the placebo group ; odds ratio [ OR ] 049 [ 95 % CI 023-102 ] ; p = 0056 ) .
-RESULTS	The prednisone group had a higher incidence of in-hospital hyperglycaemia needing insulin treatment ( 76 [ 19 % ] vs 43 [ 11 % ] ; OR 196 , 95 % CI 131-293 , p = 00010 ) .
-RESULTS	Other adverse events compatible with corticosteroid use were rare and similar in both groups .
-CONCLUSIONS	Prednisone treatment for 7 days in patients with community-acquired pneumonia admitted to hospital shortens time to clinical stability without an increase in complications .
-CONCLUSIONS	This finding is relevant from a patient perspective and an important determinant of hospital costs and efficiency .
-BACKGROUND	Swiss National Science Foundation , Viollier AG , Nora van Meeuwen Haefliger Stiftung , Julia und Gottfried Bangerter-Rhyner Stiftung .
-
-###24286286
-OBJECTIVE	The purpose of this study was to investigate the safety and efficacy of two novel light sources for large area and full body application , providing polychromatic , non-thermal photobiomodulation ( PBM ) for improving skin feeling and appearance .
-BACKGROUND	For non-thermal photorejuvenation , laser and LED light sources have been demonstrated to be safe and effective .
-BACKGROUND	However , lasers and LEDs may offer some disadvantages because of dot-shaped ( punctiform ) emission characteristics and their narrow spectral bandwidths .
-BACKGROUND	Because the action spectra for tissue regeneration and repair consist of more than one wavelength , we investigated if it is favorable to apply a polychromatic spectrum covering a broader spectral region for skin rejuvenation and repair .
-METHODS	A total of 136 volunteers participated in this prospective , randomized , and controlled study .
-METHODS	Of these volunteers , 113 subjects randomly assigned into four treatment groups were treated twice a week with either 611-650 or 570-850 nm polychromatic light ( normalized to 9 J/cm ( 2 ) in the range of 611-650 nm ) and were compared with controls ( n = 23 ) .
-METHODS	Irradiances and treatment durations varied in all treatment groups .
-METHODS	The data collected at baseline and after 30 sessions included blinded evaluations of clinical photography , ultrasonographic collagen density measurements , computerized digital profilometry , and an assessment of patient satisfaction .
-RESULTS	The treated subjects experienced significantly improved skin complexion and skin feeling , profilometrically assessed skin roughness , and ultrasonographically measured collagen density .
-RESULTS	The blinded clinical evaluation of photographs confirmed significant improvement in the intervention groups compared with the control .
-CONCLUSIONS	Broadband polychromatic PBM showed no advantage over the red-light-only spectrum .
-CONCLUSIONS	However , both novel light sources that have not been previously used for PBM have demonstrated efficacy and safety for skin rejuvenation and intradermal collagen increase when compared with controls .
-
-###25310185
-OBJECTIVE	Colon cancers deficient in mismatch repair ( MMR ) may exhibit diminished expression of the DNA repair gene , MRE11 , as a consequence of contraction of a T11 mononucleotide tract .
-OBJECTIVE	This study investigated MRE11 status and its association with prognosis , survival and drug response in patients with stage III colon cancer .
-METHODS	Cancer and Leukemia Group B 89803 ( Alliance ) randomly assigned 1,264 patients with stage III colon cancer to postoperative weekly adjuvant bolus 5-fluorouracil/leucovorin ( FU/LV ) or irinotecan + FU/LV ( IFL ) , with 8 year follow-up .
-METHODS	Tumors from these patients were analyzed to determine stability of a T11 tract in the MRE11 gene .
-METHODS	The primary endpoint was overall survival ( OS ) , and a secondary endpoint was disease-free survival ( DFS ) .
-METHODS	Non-proportional hazards were addressed using time-dependent covariates in Cox analyses .
-RESULTS	Of 625 tumor cases examined , 70 ( 11.2 % ) exhibited contraction at the T11 tract in one or both MRE11 alleles and were thus predicted to be deficient in MRE11 ( dMRE11 ) .
-RESULTS	In pooled treatment analyses , dMRE11 patients showed initially reduced DFS and OS but improved long-term DFS and OS compared with patients with an intact MRE11 T11 tract .
-RESULTS	In the subgroup of dMRE11 patients treated with IFL , an unexplained early increase in mortality but better long-term DFS than IFL-treated pMRE11 patients was observed .
-CONCLUSIONS	Analysis of this relatively small number of patients and events showed that the dMRE11 marker predicts better prognosis independent of treatment in the long-term .
-CONCLUSIONS	In subgroup analyses , dMRE11 patients treated with irinotecan exhibited unexplained short-term mortality .
-CONCLUSIONS	MRE11 status is readily assayed and may therefore prove to be a useful prognostic marker , provided that the results reported here for a relatively small number of patients can be generalized in independent analyses of larger numbers of samples .
-BACKGROUND	ClinicalTrials.gov NCT00003835 .
-
-###24576432
-OBJECTIVE	The purpose of this study was to investigate the survival effects of inferior vena cava filters in patients with venous thromboembolism ( VTE ) who had a significant bleeding risk .
-BACKGROUND	The effectiveness of inferior vena cava filter use among patients with acute symptomatic VTE and known significant bleeding risk remains unclear .
-METHODS	In this prospective cohort study of patients with acute VTE identified from the RIETE ( Computerized Registry of Patients With Venous Thromboembolism ) , we assessed the association between inferior vena cava filter insertion for known significant bleeding risk and the outcomes of all-cause mortality , pulmonary embolism ( PE ) - related mortality , and VTE rates through 30 days after the initiation of VTE treatment .
-METHODS	Propensity score matching was used to adjust for the likelihood of receiving a filter .
-RESULTS	Of the 40,142 eligible patients who had acute symptomatic VTE , 371 underwent filter placement because of known significant bleeding risk .
-RESULTS	A total of 344 patients treated with a filter were matched with 344 patients treated without a filter .
-RESULTS	Propensity score-matched pairs showed a nonsignificant trend toward lower risk of all-cause death for filter insertion compared with no insertion ( 6.6 % vs. 10.2 % ; p = 0.12 ) .
-RESULTS	The risk-adjusted PE-related mortality rate was lower for filter insertion than no insertion ( 1.7 % vs. 4.9 % ; p = 0.03 ) .
-RESULTS	Risk-adjusted recurrent VTE rates were higher for filter insertion than for no insertion ( 6.1 % vs. 0.6 % ; p < 0.001 ) .
-CONCLUSIONS	In patients presenting with VTE and with a significant bleeding risk , inferior vena cava filter insertion compared with anticoagulant therapy was associated with a lower risk of PE-related death and a higher risk of recurrent VTE .
-CONCLUSIONS	However , study design limitations do not imply a causal relationship between filter insertion and outcome .
-
-###25351481
-BACKGROUND	A model for predicting cardiovascular disease in Asian populations is limited .
-RESULTS	In total , 57 393 consecutive asymptomatic Korean individuals aged 30 to 80 years without a prior history of cardiovascular disease who underwent a general health examination were enrolled .
-RESULTS	Subjects were randomly classified into the train ( n = 45 914 ) and validation ( n = 11 479 ) cohorts .
-RESULTS	Thirty-one possible risk factors were assessed .
-RESULTS	The cardiovascular event was a composite of cardiovascular death , myocardial infarction , and stroke .
-RESULTS	In the train cohort , the C-index ( 95 % confidence interval ) and Akaike Information Criterion were used to develop the best-fitting prediction model .
-RESULTS	In the validation cohort , the predicted versus the observed cardiovascular event rates were compared by the C-index and Nam and D'Agostino ( 2 ) statistics .
-RESULTS	During a median follow-up period of 3.1 ( interquartile range , 1.9-4 .3 ) years , 458 subjects had 474 cardiovascular events .
-RESULTS	In the train cohort , the best-fitting model consisted of age , diabetes mellitus , hypertension , current smoking , family history of coronary heart disease , white blood cell , creatinine , glycohemoglobin , atrial fibrillation , blood pressure , and cholesterol ( C-index = 0.757 [ 0.726-0 .788 ] and Akaike Information Criterion = 7207 ) .
-RESULTS	When this model was tested in the validation cohort , it performed well in terms of discrimination and calibration abilities ( C-index = 0.760 [ 0.693-0 .828 ] and Nam and D'Agostino ( 2 ) statistic = 0.001 for 3 years ; C-index = 0.782 [ 0.719-0 .846 ] and Nam and D'Agostino ( 2 ) statistic = 1.037 for 5 years ) .
-CONCLUSIONS	A risk model based on traditional clinical and biomarkers has a feasible model performance in predicting cardiovascular events in an asymptomatic Korean population .
-
-###24680406
-OBJECTIVE	Non-invasive positive pressure ventilation has increasingly been chosen as the primary ventilation mode in respiratory distress syndrome ( RDS ) in preterm infants .
-OBJECTIVE	In order to further understand the application of various non-invasive positive pressure ventilation modes , we compared the advantages and disadvantages of three modes as a primary mode of ventilation in premature infants with RDS .
-METHODS	From December 2011 to March 2013 , 107 preterm infants with RDS who received intubation-pulmonary surfactant ( PS ) - extubation in our NICU were randomly divided ( by means of random number table ) into three groups based on the primary mode of ventilation : nasal continuous positive airway pressure [ NCPAP , n = 39 , male/female ratio was 27/12 , mean gestational age ( GA ) was ( 32.0 2.1 ) weeks , mean birth weight ( BW ) was ( 1752 457 ) g ] , bi-level positive airway pressure [ BiPAP , n = 35 , male/female ratio was 25/10 , GA was ( 31.4 2.0 ) weeks , BW was ( 1530 318 ) g ] , and synchronized bi-level positive airway pressure [ SBiPAP , n = 33 , male/female rate was 25/8 , GA was ( 31.5 2.2 ) weeks , BW was ( 1622 447 ) g ] .
-METHODS	Ventilation settings including FiO ( 2 ) were adjusted according to transcutaneous SPO ( 2 ) monitoring or blood gas analysis .
-METHODS	Various settings and adverse events were recorded as well .
-METHODS	The main parameter was the FiO ( 2 ) at 24 h post-positive-pressure ventilation .
-METHODS	Statistical analyses were performed using ( 2 ) test , rank sum test , one-way analysis of variance for least-significant difference value , paired-sample t-test , two related sample Wilcoxon signed rank sum test and Logistic regression .
-RESULTS	The PaCO ( 2 ) ( mmHg , 1 mmHg = 0.133 kPa ) , oxygen index ( OI ) at 12-24 h , and FiO ( 2 ) at 24 h post-ventilation in BiPAP and SBiPAP groups were lower than that in NCPAP groups with significant difference ( 44 9 and 45 9 vs. 50 9 , 2.76 0.96 and 2.79 0.60 vs. 3.24 0.72 , 0.34 0.10 and 0.35 0.07 vs. 0.39 0.07 ; F = 4.456 , 5.146 and 4.123 ; P = 0.014 , 0.007 and 0.019 , respectively ) .
-RESULTS	There was no significant difference between BiPAP and SBiPAP groups .
-RESULTS	There was no significant difference among three groups ( all P > 0.05 ) in the following events : respiratory index ( RI ) at 12-24 h post-ventilation , abdominal distension , period of non-invasive ventilation , ratio of intubation for invasive ventilation if failed noninvasive ventilation , air-leak syndrome , neonatal necrotizing enterocolitis , periventricular-intraventricular haemorrhage , bronchopulmonary dysplasia , retinopathy of prematurity , mortality rate after 36 h of age or rate of abandon for discharge .
-RESULTS	The independent risk factors for failure of non-invasive positive pressure ventilation were gender , gestational age , antepartum steroid at 24 h before birth to 7 d , and birth weight , with the OR ( 95 % confidence interval ) being 14.120 ( 1.135 , 175.662 ) , 2.862 ( 1.479 , 5.535 ) , 61.084 ( 3.115 , 1 198.031 ) , and 8.306 ( 1.488 , 46.383 ) , respectively .
-CONCLUSIONS	As the primary mode of ventilation in premature infants with RDS , both BiPAP and SBiPAP are more beneficial than NCPAP in improving oxygenation and reducing CO ( 2 ) retention without increasing the incidence of adverse events .
-
-###25608428
-OBJECTIVE	The purpose of this study was to reexamine the factor pattern of the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale ( FACIT-Sp-12 ) using exploratory factor analysis in people newly diagnosed with advanced cancer .
-METHODS	Principal components analysis ( PCA ) and 3 common factor analysis methods were used to explore the factor pattern of the FACIT-Sp-12 .
-METHODS	Factorial validity was assessed in association with quality of life ( QOL ) .
-RESULTS	Principal factor analysis ( PFA ) , iterative PFA , and maximum likelihood suggested retrieving 3 factors : Peace , Meaning , and Faith .
-RESULTS	Both Peace and Meaning positively related to QOL , whereas only Peace uniquely contributed to QOL .
-CONCLUSIONS	This study supported the 3-factor model of the FACIT-Sp-12 .
-CONCLUSIONS	Suggestions for revision of items and further validation of the identified factor pattern were provided .
-
-###25122031
-OBJECTIVE	We examined the impact of a prenatal exercise intervention on physical activity in 260 women at risk for gestational diabetes mellitus .
-METHODS	We randomized participants in the Behaviors Affecting Baby and You ( BABY ) Study , which took place from 2007 to 2012 , to either a 12-week individually tailored , motivationally matched exercise intervention ( n = 132 ) or to a comparison health and wellness intervention ( n = 128 ) .
-METHODS	We assessed physical activity with the Pregnancy Physical Activity Questionnaire .
-METHODS	We used linear mixed models to evaluate the impact of the interventions on change in physical activity according to intensity and type , total walking , and sedentary behavior .
-RESULTS	Compared with the health and wellness arm , the exercise arm had significantly greater increases in sports or exercise activity ( 0.3 vs 5.3 metabolic equivalent of task [ MET ] hours/week ; P < .001 ) , and smaller declines in total activity ( -42.7 vs -2.1 MET hours/week ; P = .02 ) and activities of moderate to vigorous intensity ( -30.6 vs -10.6 MET hours/week ; P = .05 ) , and was more likely to achieve recommended guidelines for physical activity ( odds ratio = 2.12 ; 95 % confidence interval = 1.45 , 3.10 ) .
-CONCLUSIONS	These findings extend the previous literature by demonstrating the benefits of a clinically feasible exercise intervention in an ethnically and socio-economically diverse population .
-CONCLUSIONS	Given the increased risk of adverse maternal health outcomes in ethnic minority groups , these findings may have important implications for reducing health disparities .
-
-###25740851
-OBJECTIVE	Selenium is present in the active site of proteins important for thyroid hormone synthesis and metabolism .
-OBJECTIVE	The objective of this study is to investigate the effect of selenium supplementation in different doses on thyroid function , under conditions of suboptimal dietary selenium intake .
-METHODS	The Danish PREvention of Cancer by Intervention with SElenium pilot study ( DK-PRECISE ) is a randomized , double-blinded , placebo-controlled trial .
-METHODS	A total of 491 males and females aged 60-74 years were randomized to 100g ( n = 124 ) , 200g ( n = 122 ) , or 300g ( n = 119 ) selenium-enriched yeast or matching yeast-based placebo tablets ( n = 126 ) .
-METHODS	A total of 361 participants , equally distributed across treatment groups , completed the 5-year intervention period .
-METHODS	Plasma samples were analyzed for selenium and serum samples for TSH , free triiodothyronine ( FT3 ) , and free thyroxine ( FT4 ) at baseline , and after 6 months , and 5 years of supplementation .
-RESULTS	Plasma selenium concentrations increased significantly and dose-dependently in treatment groups receiving selenium ( P < 0.001 ) .
-RESULTS	Serum TSH and FT4 concentrations decreased significantly and dose-dependently by 0.066 mIU/l ( P = 0.010 ) and 0.11 pmol/l ( P = 0.015 ) , respectively , per 100g/day increase , with insignificant differences between 6 months and 5 years .
-RESULTS	No significant effects were found for FT3 and FT3 : FT4 ratio .
-CONCLUSIONS	In euthyroid subjects , selenium supplementation minutely and dose-dependently affects thyroid function , when compared with placebo , by decreasing serum TSH and FT4 concentrations .
-CONCLUSIONS	Based on these findings , selenium supplementation is not warranted under conditions of marginal selenium deficiency .
-CONCLUSIONS	However , a role for selenium supplementation in the treatment of autoimmune thyroid diseases is still unresolved .
-
-###24694876
-BACKGROUND	We aimed to compare the effect of repaglinide and metformin monotherapy as an initial therapy in Chinese patients with newly diagnosed type 2 diabetes mellitus ( T2DM ) .
-METHODS	In this 15-week , open-labelled , parallel-controlled , randomised study , 60 Chinese drug-naive patients with newly diagnosed T2DM were randomised ( 2:1 ) to receive repaglinide or metformin monotherapy .
-METHODS	Primary endpoint was change in HbA1c from baseline to the end of the trial .
-METHODS	Secondary endpoints included changes in glycaemic variability , insulin sensitivity and - cell function .
-RESULTS	Patients in both repaglinide and metformin groups achieved significant reductions in HbA1c ( -1.8 1.5 vs -1.6 1.5 % ) , FPG ( fasting blood glucose ) ( -1.7 1.7 vs -2.1 1.7 mmol/l ) and 2-hPPG ( post-prandial glucose ) ( -3.8 3.1 vs -3.8 3.6 mmol/l ) , with no statistical differences between the groups .
-RESULTS	Glycaemic variability , glucose infusion rate and - cell function were all significantly improved from baseline in the two groups ( all P < 0.05 ) , without any statistical differences in the improvement between the groups .
-CONCLUSIONS	Repaglinide and metformin achieved comparable efficacy in improving glycaemic control , reducing glycaemic variability , enhancing insulin sensitivity and ameliorating - cell function .
-CONCLUSIONS	Therefore , repaglinide is an optional agent for initial therapy in Chinese patients with newly diagnosed T2DM .
-
-###24388792
-BACKGROUND	Standard bowel cleansing for colon capsule endoscopy ( CCE ) requires a liquid diet and bowel laxatives for at least 2 days , which is a major drawback of this procedure and affects tolerance and acceptability .
-OBJECTIVE	To compare the quality of colon cleanliness achieved with one-day versus two-day bowel preparation in outpatients undergoing CCE .
-METHODS	Patients were randomly assigned to one of two groups : group I ( one-day schedule , n = 20 ) received a fiber-free diet and 3 L of polyethylene glycol ( PEG ) on day 0 ; group II ( two-day schedule , n = 20 ) received a liquid diet and 3 L of PEG in the evening of day -1 , and 1L of PEG in the early morning of day 0 .
-METHODS	In both groups , the patients received 15 mg bisacodyl on day -1 and one or two additional sodium phosphate ( NaP ) boosters following capsule ingestion .
-METHODS	Each colon segment was assessed for cleanliness using a four-point grading scale ( excellent = 1 , good = 2 , fair = 3 , and poor = 4 ) .
-METHODS	For the final analysis , colon cleanliness was rated as adequate ( good or excellent ) or inadequate ( fair or poor ) .
-RESULTS	Overall colon cleanliness was adequate in 94 % ( CI 91-97 ) of patients in group I versus 80 % ( CI 72-88 ) in group II ( P = 0.27 ) .
-RESULTS	No significant differences were observed in the per-segment quality of colon cleansing between the two groups .
-RESULTS	CCE reached the rectum in 80 % ( CI 73-87 ) of patients in group I versus 75 % ( CI 67-83 ) in group II ( p = 0.59 ) .
-CONCLUSIONS	The quality of colon cleanliness achieved with one-day bowel preparation is equivalent to that of the standard two-day schedule in patients undergoing CCE .
-
-###24946635
-OBJECTIVE	To compare the efficacy difference in the treatment of chronic pelvic pain syndrome of Sev-damp-heat stagnation pattern between acupoint catgut embedding therapy and western medication .
-METHODS	enty cases were randomized into a catgut embedding group ( 40 cases ) and a western medication group ( 30 cases ) at the ratio of 4 : 3 .
-METHODS	In the catgut embedding group , the catgut embedding therapy was applied to Sanyinjiao ( SP 6 ) , Quchi ( LI 11 ) , Huiyin ( CV 1 ) , Zusanli ( ST 36 ) , Zhongji ( CV 3 ) , Shenshu ( BL 23 ) , etc. .
-METHODS	The treatment was given once every two weeks , the treatment for 4 weeks was as one session and totally 2 sessions were required .
-METHODS	In the western medication group , tamsulosin hydrochloride capsules 0.2 mg , oral administration , once a day , and Indometacin sustained release tablets , 75 mg , once a day , 3 tablets each time were prescribed .
-METHODS	The symptom score of TCM , score of NIH Chronic Prostatitis Symptom Index ( NIH-CPSI ) , lecithin body number in prostatic fluid , ( SAS ) score of Self-Rating Anxiety Scale and score of Self-Rating Depression Scale ( SDS ) were compared before and after treatment in the patients of the two groups .
-METHODS	The efficacy was evaluated in the two groups .
-RESULTS	( 1 ) The total effective rate was 91.9 % ( 34/37 ) in the catgutembedding group and was 86.2 % ( 25/29 ) in the western medication group .
-RESULTS	The efficacy in the catgutembedding group was better than that in the western medication group ( P < 0.05 ) .
-RESULTS	( 2 ) The symptom score of TCM was all reduced significantly after treatment in the two groups ( both P < 0.01 ) , and the result in the catgut embedding group was superior to the western medication group ( 6.42 + / -2.81 vs 10.99 + / -3.11 , P < 0.01 ) .
-RESULTS	( 3 ) Lecithin body number was increased apparently in the two groups after treatment ( both P < 0.01 ) , and the result in the catgut-embedding group was superior to the western medicine group ( 33.56 + / -5.88 vs 29.78 + / -7.06 , P < 0.05 ) .
-RESULTS	( 4 ) Total score of NIH-CPSI , score of pain , score of SAS and score of SDS were all improved apparently after treatment in the two groups ( all P < 0.01 ) , and the results in the catgut embedding group were superior to the western medication group ( P < 0.01 , P < 0.05 ) .
-CONCLUSIONS	The acupoint catgut embedding therapy achieves the superior efficacy on chronic pelvic pain syndrome of damp-heat stagnation pattern as compared with conventional western medicine .
-CONCLUSIONS	This therapy relieves clinical symptoms , improves the states of anxiety and depression and increases lecithin body number obviously .
-
-###24586897
-BACKGROUND	A recent paper reported the outcomes of a study examining a new self-guided internet-delivered treatment , the Wellbeing Course , for symptoms of anxiety or depression .
-BACKGROUND	This study found the intervention resulted in significant symptom reductions .
-BACKGROUND	It also found that automated emails increased treatment completion and clinical improvements in a subsample with elevated anxiety and depression .
-OBJECTIVE	To examine the clinical outcomes and the effect of automated emails at 12 months post-treatment .
-METHODS	Participants , who were randomly allocated to a Treatment Plus Automated Emails Group ( TEG ; n = 100 ) , a standard Treatment Group ( TG ; n = 106 ) or delayed-treatment Waitlist Control Group ( Control ; n = 51 ) , were followed up at 12 months post-treatment .
-METHODS	Eighty-one percent , 78 % and 87 % of participants in the TEG , TG and treated Waitlist Control Group provided symptom data at 12-month follow-up , respectively .
-METHODS	The primary outcome measures were the Patient Health Questionnaire-9 Item Scale ( PHQ-9 ) and the Generalized Anxiety Disorder-7 Item Scale ( GAD-7 ) .
-RESULTS	Significant improvements in symptoms of anxiety and depression were observed over time in both the TEG and TG ( Fs > 69 , ps < .001 ) these were sustained from post-treatment to 12-month follow-up ( ps > .05 ) , and were associated with large effect sizes .
-RESULTS	No statistically significant differences in symptoms were found between the TEG and TG at post-treatment , 3-month or 12-month follow-up .
-RESULTS	Previously reported symptom differences between TEG and TG participants with comorbid symptoms were no longer present at 12-month follow-up ( ps > .70 ) .
-CONCLUSIONS	The overall benefits of the Wellbeing Course were sustained at 12-month follow-up .
-CONCLUSIONS	Although automated emails facilitated Course completion and reductions in symptoms for participants with comorbid anxiety and depression from pre-post treatment , these differences were no longer observed at 12-month follow-up .
-CONCLUSIONS	The results indicate that automated emails promote more rapid treatment response for people with elevated and comorbid symptoms , but may not improve longer term outcomes .
-BACKGROUND	Australian and New Zealand Clinical Trials Registry ACTRN12610001058066 .
-
-###25590501
-OBJECTIVE	To explore the differential effect of a multifaceted intervention on hospital-based maternal mortality between patients with cesarean and vaginal delivery in low-resource settings .
-METHODS	We reanalyzed the data from a major cluster-randomized controlled trial , QUARITE ( Quality of care , Risk management and technology in obstetrics ) .
-METHODS	These subgroup analyses were not pre-specified and were treated as exploratory .
-METHODS	The intervention consisted of an initial interactive workshop and quarterly educational clinically oriented and evidence-based outreach visits focused on maternal death reviews ( MDR ) and best practices implementation .
-METHODS	The trial originally recruited 191,167 patients who delivered in each of the 46 participating hospitals in Mali and Senegal , between 2007 and 2011 .
-METHODS	The primary endpoint was hospital-based maternal mortality .
-METHODS	Subgroup-specific Odds Ratios ( ORs ) of maternal mortality were computed and tested for differential intervention effect using generalized linear mixed model between two subgroups ( cesarean : 40,975 ; and vaginal delivery : 150,192 ) .
-RESULTS	The test for homogeneity of intervention effects on hospital-based maternal mortality among the two delivery mode subgroups was statistically significant ( p-value : 0.0201 ) .
-RESULTS	Compared to the control , the adjusted OR of maternal mortality was 0.71 ( 95 % CI : 0.58-0 .82 , p = 0.0034 ) among women with cesarean delivery .
-RESULTS	The intervention had no significant effect among women with vaginal delivery ( adjusted OR 0.87 , 95 % CI 0.69-1 .11 , p = 0.6213 ) .
-RESULTS	This differential effect was particularly marked for district hospitals .
-CONCLUSIONS	Maternal deaths reviews and on-site training on emergency obstetric care may be more effective in reducing maternal mortality among high-risk women who need a cesarean section than among low-risk women with vaginal delivery .
-
-###24460827
-BACKGROUND	Tuberculosis is a public health problem in Cameroon , just like in many other countries in the world .
-BACKGROUND	The National Tuberculosis Control Programme ( PNLT ) put in place by the state , aims to fight tuberculosis through the implementation of international directives ( Directly Observed Treatment Short , DOTS ) .
-BACKGROUND	Despite the deployment of this strategy across the world , its implementation is difficult in the context of low-resource countries .
-BACKGROUND	Some expected results are not achieved .
-BACKGROUND	In Cameroon , the cure rate for patients with sputum positive pulmonary tuberculosis ( TPM + ) after 6 months is only about 65 % , 20 % below the target .
-BACKGROUND	This is mainly due to poor patient adherence to treatment .
-BACKGROUND	By relying on the potential of mobile Health , the objective of this study is to evaluate the effect of SMS reminders on the cure rate of TPM + patients , measured using 6-month bacilloscopy .
-METHODS	This is a blinded , randomised controlled multicentre study carried out in Cameroon .
-METHODS	The research hypothesis is that sending daily SMS messages to remind patients to take their prescribed tuberculosis medication , together with the standard DOTS strategy , will increase the cure rate from 65 % ( control group : DOTS , no SMS intervention ) to 85 % ( intervention group : DOTS , with SMS intervention ) in a group of new TPM + patients .
-METHODS	In accordance with each treatment centre , the participants will be randomly allocated into the two groups using a computer program : the intervention group and the control group .
-METHODS	A member of the research team will send daily SMS messages .
-METHODS	Study data will be collected by health professionals involved in the care of patients .
-METHODS	Data analysis will be done by the intention-to-treat method .
-CONCLUSIONS	The achieving of expected outcomes by the PNLT through implementation of DOTS requires several challenges .
-CONCLUSIONS	Although it has been demonstrated that the DOTS strategy is effective in the fight against tuberculosis , its application remains difficult in developing countries .
-CONCLUSIONS	This study explores the potential of mHealth to support DOTS strategy .
-CONCLUSIONS	It will gather new evidence on the effectiveness of mHealth-based interventions and SMS reminders in the improvement of treatment adherence and the cure rate of tuberculosis patients , especially in a low-resource country such as Cameroon .
-BACKGROUND	The trial is registered on the Pan-African Clinical Trials Registry ( http://www.pactr.org ) under unique identification number : PACTR201307000583416 .
-
-###24806873
-BACKGROUND	Depression is common in nursing home ( NH ) patients with dementia , and often clustered with anxiety and other mood symptoms .
-BACKGROUND	An association between pain and depressive symptoms has been reported , but the impact of pain management on depression and other mood symptoms has not been investigated .
-OBJECTIVE	Secondary analyses of a cluster randomized clinical trial examine the response of dementia-related mood symptoms to a Stepwise Protocol of Treating Pain .
-METHODS	Three-hundred fifty-two patients with moderate and severe dementia and significant behavioural disturbances , related to 60 clusters ( i.e. clusters defined as single independent NH units ) in 18 NHs of Western Norway , were included .
-METHODS	All patients in the intervention group received individual daily pain treatment with paracetamol , extended release morphine , buprenorphine transdermal patch or pregabaline for 8weeks , with additional follow-up assessment 4weeks after completion of the intervention .
-METHODS	Clusters randomized to control received usual treatment .
-METHODS	A mood cluster consisting of depression , anxiety , sleep disorders , apathy and appetite items from the Neuropsychiatric Inventory-Nursing Home ( NPI-NH ) was the primary outcome .
-RESULTS	Analysed by Mann-Whitney U-tests , Stepwise Protocol of Treating Pain conferred significant benefit in treatment of the NPI-NH mood cluster ( F = 13.4 , df = 1 ; 299 , p < 0.001 ) and depression ( F = 2.0 , df = 1 ; 301 , p = 0.025 ) .
-RESULTS	Further analyses highlighted improvements in apathy ( F = 5.3 , df = 1 ; 300 , p = 0.017 ) , night-time behaviours ( F = 3.1 , df = 1 ; 301 , p = 0.050 ) , and appetite items ( F = 11.6 , df = 1 ; 301 , p = 0.005 ) , but not irritability ( p = 0.092 ) and anxiety ( p = 0.125 ) .
-CONCLUSIONS	Mood symptoms including depression significantly improved with pain treatment , emphasizing the importance of more rigorous treatment of pain in agitated people with dementia .
-CONCLUSIONS	Findings have potentially immediate clinical relevance .
-
-###25549690
-OBJECTIVE	Specific computer-based auditory training may be a useful completion in the rehabilitation process for cochlear implant ( CI ) listeners to achieve sufficient speech intelligibility .
-OBJECTIVE	This study evaluated the effectiveness of a computerized , phoneme-discrimination training programme .
-METHODS	The study employed a pretest-post-test design ; participants were randomly assigned to the training or control group .
-METHODS	Over a period of three weeks , the training group was instructed to train in phoneme discrimination via computer , twice a week .
-METHODS	Sentence recognition in different noise conditions ( moderate to difficult ) was tested pre - and post-training , and six months after the training was completed .
-METHODS	The control group was tested and retested within one month .
-METHODS	Twenty-seven adult CI listeners who had been using cochlear implants for more than two years participated in the programme ; 15 adults in the training group , 12 adults in the control group .
-RESULTS	Besides significant improvements for the trained phoneme-identification task , a generalized training effect was noted via significantly improved sentence recognition in moderate noise .
-RESULTS	No significant changes were noted in the difficult noise conditions .
-RESULTS	Improved performance was maintained over an extended period .
-CONCLUSIONS	Phoneme-discrimination training improves experienced CI listeners ' speech perception in noise .
-CONCLUSIONS	Additional research is needed to optimize auditory training for individual benefit .
-
-###25440382
-OBJECTIVE	In clinical trials where participants are likely to be able to distinguish between true and sham interventions , informing participants that they may receive a sham intervention increases the likelihood of participants ` breaking the blind ' and invalidating trial findings .
-OBJECTIVE	The present study explored participants ' perceptions of the consent process in a sham controlled acupressure trial which did not explicitly indicate participants may receive a sham intervention .
-METHODS	Nested qualitative study within a randomised sham controlled trial of acupressure wristbands for chemotherapy-related nausea .
-METHODS	Convenience sample of 26 patients participated in semi-structured interviews .
-METHODS	Interviews were audio-recorded and transcribed verbatim .
-METHODS	Transcripts analysed thematically using framework analysis .
-METHODS	Study conducted within three geographical sites in the UK : Manchester , Liverpool , and Plymouth .
-RESULTS	All participants indicated that they believed they were fully informed when providing written consent to participate in the trial .
-RESULTS	Participants ' perceived it was acceptable to employ a sham intervention within the trial of acupressure wristbands without informing potential participants that they may receive a sham treatment .
-RESULTS	Despite the fact that participants were not informed that one of the treatment arms was a sham intervention the majority indicated they assumed one of the treatment arms would be placebo .
-CONCLUSIONS	Many trials of acupuncture and acupressure do not inform participants they may receive a sham intervention .
-CONCLUSIONS	The current study indicates patients ' perceive this approach to the consent process as acceptable .
-CONCLUSIONS	However , the fact participants assume one treatment may be placebo threatens the methodological basis for utilising this approach to the consent process .
-
-###24912456
-BACKGROUND	Bipolar disorder ( BD ) and borderline personality disorder ( BPD ) both are severe and chronic psychiatric disorders .
-BACKGROUND	Both disorders have overlapping symptoms , and current research shows that the presence of a BPD has an adverse effect on the course of BD .
-BACKGROUND	The limited research available shows an unfavorable illness course , a worse prognosis and response to medication , longer treatment duration , more frequent psychiatric admissions , higher drop-out , increased risk of substance abuse , increased risk of suicide , and more impairment of social and occupational functioning .
-BACKGROUND	However , there is no research available on the effect of specific psychotherapeutic treatment for this patients .
-METHODS	This paper presents the protocol of a RCT to investigate the presence of borderline personality features in patients treated for BD ( study part 1 ) and the effectiveness of STEPPS ( Systems Training for Emotional Predictability and Problem Solving ) added to treatment as usual ( TAU ) for BD compared to TAU in patients with BD and comorbid borderline personality features ( study part 2 ) .
-METHODS	STEPPS is a validated and effective intervention for BPD .
-METHODS	The study population consists of patients treated for BD at specialized outpatient clinics for BD in the Netherlands .
-METHODS	At first the prevalence of comorbid borderline personality features in outpatients with BD is investigated .
-METHODS	Inclusion criteria for study part 2 is defined as having three or more of the DSM-IV-TR diagnostic criteria of BPD , including impulsivity and anger bursts .
-METHODS	Primary outcomes will be the frequency and severity of manic and depressive recurrences as well as severity , course and burden of borderline personality features .
-METHODS	Secondary outcomes will be quality of life , utilizing mental healthcare and psychopathologic symptoms not primarily related to BD or BPD .
-METHODS	Assessment will be at baseline , at the end of the intervention , and at 12 and 18 months follow-up .
-CONCLUSIONS	This will be the first randomized controlled trial of a specific intervention in patients with BD and comorbid BPD or borderline personality features .
-CONCLUSIONS	There are no recommendations in the guideline of treatment of bipolar disorders for patients with this complex comorbidity .
-CONCLUSIONS	We expect that a combined treatment aimed at mood disorder and emotion regulation will improve treatment outcomes for these patients .
-
-###24928472
-BACKGROUND	Although serum under-O-glycosylated IgA1 in IgA nephropathy ( IgAN ) patients may deposit more preferentially in glomeruli than heavily-O-glycosylated IgA1 , the relationship between the glomerular IgA deposition level and the O-glycan profiles of serum IgA1 remains obscure .
-METHODS	Serum total under-O-glycosylated IgA1 levels were quantified in 32 IgAN patients by an enzyme-linked immunosorbent assay ( ELISA ) with Helix aspersa ( HAA ) lectin .
-METHODS	Serum under-O-glycosylated polymeric IgA1 ( pIgA1 ) was selectively measured by an original method using mouse Fc / receptor ( mFc/R ) transfectant and flow cytometry ( pIgA1 trap ) .
-METHODS	The percentage area of IgA deposition in the whole glomeruli ( Area-IgA ) was quantified by image analysis on the immunofluorescence of biopsy specimens .
-METHODS	Correlations were assessed between the Area-IgA and data from HAA-ELISA or pIgA1 trap .
-METHODS	The relationships between clinical parameters and data from HAA-ELISA or pIgA1 trap were analyzed by data mining approach .
-RESULTS	While the under-O-glycosylated IgA1 levels in IgAN patients were significantly higher than those in healthy controls when measured ( p < 0.05 ) , there was no significant difference in under-O-glycosylated pIgA1 .
-RESULTS	There was neither a correlation observed between the data from HAA-ELISA and pIgA1 trap ( r2 = 0.09 ) in the IgAN patients ( r2 = 0.005 ) nor was there a linear correlation between Area-IgA and data from HAA-ELISA or the pIgA1 trap ( r2 = 0.005 , 0.03 , respectively ) .
-RESULTS	Contour plots of clinical parameters versus data from HAA-ELISA and the pIgA1 trap revealed that patients with a high score in each clinical parameter concentrated in specific areas , showing that patients with specific O-glycan profiles of IgA1 have similar clinical parameters .
-RESULTS	A decision tree analysis suggested that dominant immune complexes in glomeruli were consisted of : 1 ) IgA1-IgG and complements , 2 ) pIgA1 and complements , and 3 ) monomeric IgA1-IgA or aggregated monomeric IgA1 .
-CONCLUSIONS	Serum under-O-glycosylated IgA1 levels are not correlated with glomerular IgA deposition based upon heterogeneity in the composition of glomerular immune complexes in IgAN patients .
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-###25521726
-OBJECTIVE	Proton-pump inhibitors are known to be effective in the treatment and prevention of ulcers related to low-dose aspirin ( LDA ) , but few reports address H2 - receptor antagonists ( H2RAs ) and gastroprotective agents ( GPs ) .
-OBJECTIVE	This study was intended to compare the therapeutic effects of an H2RA and a GP against gastroduodenal mucosal injuries in patients taking LDA .
-METHODS	The subjects consisted of patients requiring continuous LDA treatment , in whom no peptic ulcer was found on endoscopy at enrollment .
-METHODS	The patients were randomized to either famotidine 20mg/day ( group F ) or teprenone 150mg/day ( group T ) .
-METHODS	The study medication was administered for 12 weeks .
-METHODS	The patients underwent endoscopy after administration of the study medication in order to obtain a Lanza score .
-RESULTS	A total of 66 patients ( 38 in group F , 28 in group T ) were included in the efficacy analysis population .
-RESULTS	The Lanza score changed as follows : in group F , it improved significantly , from 0.891.03 ( meanstandard deviation ) before medication to 0.390.75 after medication ( P = 0.006 ) ; in group T , no significant difference was observed : 0.750.93 before medication and 0.680.82 after medication .
-CONCLUSIONS	Famotidine is better than teprenone in terms of reducing the number of the erosions under use of LDA .
-
-###24368725
-OBJECTIVE	To evaluate the effect of exogenous creatine phosphate ( CP ) on myocardial injury after percutaneous coronary intervention ( PCI ) .
-METHODS	Four hundred patients were divided to receive conventional therapy ( control group ) or 3-day intravenous infusion of CP after PCI ( CP group ) .
-METHODS	Levels of creatine kinase MB ( CK-MB ) and troponin I ( TnI ) were measured before and on postprocedural day 3 .
-RESULTS	Postprocedural CK-MB and TnI in the CP group were significantly increased compared to the control group .
-RESULTS	In the CP group , 8.0 % and 5.0 % of patients had an increase in CK-MB 1 to 3 times and > 3 times , respectively , which were significantly lower than that of the control group ( 19.0 % and 9.0 % , respectively ) ; 12.0 % and 10.0 % of patients had an increase in TnI 1 to 3 times and > 3 times , respectively , which were significantly lower than that of the control group ( 21.0 % and 18.0 % , respectively ) .
-CONCLUSIONS	Exogenous CP was helpful to reduce myocardial injury after PCI .
-
-###25440329
-BACKGROUND	A relationship between echolucency of carotid plaques and the consequent risk of ipsilateral ischemic stroke has been observed .
-BACKGROUND	An aggressive lipid-lowering therapy may increase the echogenicity of carotid plaque in patients with elevated low-density lipoprotein cholesterol levels .
-BACKGROUND	The aim of this study is to prospectively evaluate the long-term effect of high-dose atorvastatin on carotid plaque morphology in patients with first-ever transient ischemic attack or stroke .
-METHODS	All patients with symptomatic first ischemic atherosclerotic cerebrovascular event occurred within the previous 10 days were enrolled .
-METHODS	Carotid Doppler ultrasound of the neck vessels with 7-11 MHz probe for the definition of the atherosclerotic carotid framework was performed .
-METHODS	The analysis of the gray-scale median ( GSM ) of each plate was carried out with image processing software .
-RESULTS	A total of 240 symptomatic plaques were included and divided into 3 groups : 80 in group A ( atorvastatin 80 mg ) , 80 in group B ( atorvastatin 40 mg ) , and 80 to group C ( no atorvastatin ) .
-RESULTS	GSM score increases significantly more extensive in group A than in group B ( +48.65 vs. +39.46 , P < .02 ) and group C ( +48.65 vs. 19.3 , P = .0002 ) .
-RESULTS	An inverse association between reduction of low-density lipoprotein and the increase in the GSM score ( r = -.456 , P = .007 ) has been observed .
-RESULTS	Moreover , the reduction of high-sensitive C-reactive protein correlates inversely with the increase of the GSM ( r = -.398 , P = .021 ) .
-CONCLUSIONS	Dose-dependent effect of atorvastatin on symptomatic carotid plaque morphology may suggest a specific role of this drug in the atherosclerotic stroke prevention .
-
-###24222508
-BACKGROUND	Although social support is an integral element in smoking cessation , the literature presents mixed findings regarding the type ( s ) of social support that are most helpful .
-BACKGROUND	The Partner Interaction Questionnaire ( PIQ ) is commonly used to measure social support in this context .
-OBJECTIVE	We explored the possibility that more nuanced distinctions between items on the PIQ than what is customarily used could improve the prediction of cessation .
-METHODS	Baseline PIQ responses of smokers enrolled in a cessation program was submitted to an exploratory factor analysis .
-METHODS	Emergent factors were used to predict cessation at several time points .
-RESULTS	Four factors emerged , which differed from the two subscales that are typically used .
-RESULTS	The four-factor version predicted cessation ; the two-factor version did not .
-CONCLUSIONS	Identifying the types of social support that predict smoking cessation depend on our ability to measure social support .
-CONCLUSIONS	More nuanced measures will likely clarify the role of social support in cessation .
-
-###24687182
-OBJECTIVE	The present intervention study investigated the efficacy of the ACT & Check Strategy intervention to improve inference generation when reading , metacognitive ability , general reading comprehension , and social inference ability in adults with high-functioning autism spectrum disorder ( HF-ASD ) .
-METHODS	Twenty-five adults with HF-ASD were randomly assigned to either a treatment or a control group .
-METHODS	Treatment sessions were conducted in 1-hr sessions , twice a week , for a total of 6 weeks .
-METHODS	Treatment focused on explicit instruction of components of inference generation , categories of inferences , and increasingly independent strategy use .
-RESULTS	The treatment group demonstrated significantly superior performance on 1 of 2 measures of inference generation in reading and 1 measure of metacognitive ability compared with the control group .
-RESULTS	Significant differences between groups were not found on measures of reading comprehension or social inference ability .
-CONCLUSIONS	These findings suggest that the ACT & Check Strategy was effective in improving participants ' ability to generate inferences in reading and certain metacognitive abilities , but the skills do not appear to generalize to other social communication contexts , such as social inference generation .
-CONCLUSIONS	This research provides a measure of support for explicitly teaching inference generation to address a reading inference deficit in adults with HF-ASD .
-
-###25218922
-OBJECTIVE	Previous studies have revealed lower prostate specific antigen concentrations in men with type 2 diabetes , paralleling the reported lower prevalence of prostate cancer in diabetic men .
-OBJECTIVE	Data are lacking on prostate specific antigen in men with type 1 diabetes whose insulin and obesity profiles differ from those with type 2 diabetes mellitus .
-OBJECTIVE	In this study we examined the relationship between long-term glycemic control and prostate specific antigen in men with type 1 diabetes mellitus .
-METHODS	Total prostate specific antigen was measured at one time in 639 men in the EDIC , the observational followup of participants in the DCCT .
-METHODS	The relationship between DCCT/EDIC weighted mean hemoglobin A1c and log prostate specific antigen was assessed using linear regression modeling after adjusting for age , body mass index , total testosterone , statin and thiazide medication use , diabetes duration , and DCCT randomization arm and cohort .
-RESULTS	Median subject age was 52 years , body mass index was 28.4 kg/m ( 2 ) and DCCT/EDIC time-weighted hemoglobin A1c was 7.9 % .
-RESULTS	Median prostate specific antigen was 0.64 ng/ml ( IQR 0.43 , 1.05 ) .
-RESULTS	Prostate specific antigen increased significantly with age ( p < 0.0001 ) and with lower time-weighted hemoglobin A1c ( p < 0.0001 ) .
-RESULTS	Each 10 % increase in hemoglobin A1c was accompanied by an 11 % reduction in prostate specific antigen ( p = 0.0001 ) .
-CONCLUSIONS	Prostate specific antigen decreases as hemoglobin A1c increases in men with type 1 diabetes mellitus .
-CONCLUSIONS	This relationship is independent of age , body mass index , androgen levels , medication use and measures of diabetes severity , which suggests that factors related to glycemia may directly affect prostate specific antigen levels .
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-###24612686
-BACKGROUND	To validate the association between accommodation and visual asthenopia by measuring objective accommodative amplitude with the Optical Quality Analysis System ( OQAS , Visiometrics , Terrassa , Spain ) , and to investigate associations among accommodation , ocular surface instability , and visual asthenopia while viewing 3D displays .
-METHODS	Fifteen normal adults without any ocular disease or surgical history watched the same 3D and 2D displays for 30 minutes .
-METHODS	Accommodative ability , ocular protection index ( OPI ) , and total ocular symptom scores were evaluated before and after viewing the 3D and 2D displays .
-METHODS	Accommodative ability was evaluated by the near point of accommodation ( NPA ) and OQAS to ensure reliability .
-METHODS	The OPI was calculated by dividing the tear breakup time ( TBUT ) by the interblink interval ( IBI ) .
-METHODS	The changes in accommodative ability , OPI , and total ocular symptom scores after viewing 3D and 2D displays were evaluated .
-RESULTS	Accommodative ability evaluated by NPA and OQAS , OPI , and total ocular symptom scores changed significantly after 3D viewing ( p = 0.005 , 0.003 , 0.006 , and 0.003 , respectively ) , but yielded no difference after 2D viewing .
-RESULTS	The objective measurement by OQAS verified the decrease of accommodative ability while viewing 3D displays .
-RESULTS	The change of NPA , OPI , and total ocular symptom scores after 3D viewing had a significant correlation ( p < 0.05 ) , implying direct associations among these factors .
-CONCLUSIONS	The decrease of accommodative ability after 3D viewing was validated by both subjective and objective methods in our study .
-CONCLUSIONS	Further , the deterioration of accommodative ability and ocular surface stability may be causative factors of visual asthenopia in individuals viewing 3D displays .
-
-###25044176
-OBJECTIVE	Vitamin D insufficiency is common in subjects with type 2 diabetes .
-OBJECTIVE	Observational studies suggest that vitamin D plays a role in the pathogenesis of type 2 diabetes .
-OBJECTIVE	However , results of intervention studies have been inconsistent .
-OBJECTIVE	We investigated the effects of improving vitamin D status on insulin sensitivity , insulin secretion , and inflammatory markers in patients with type 2 diabetes .
-METHODS	A double blind , randomized , placebo controlled trial was conducted .
-METHODS	Sixteen patients with type 2 diabetes and hypovitaminosis D were recruited .
-METHODS	Eight patients received colecalciferol and ( 280 g daily for 2 weeks , 140 g daily for 10 weeks ) and 8 patients received identical placebo tablets for 12 weeks .
-METHODS	Before and after intervention , patients underwent IVGTT , hyperinsulinemic euglycemic clamp , assessment of baseline high-frequency insulin pulsatility , glucose-entrained insulin pulsatility , DXA scans , 24-hour-ambulatory blood pressure monitorings , and fasting blood samples .
-RESULTS	Serum-25 ( OH ) vitamin D and serum-1 ,25 ( OH ) vitamin D increased significantly after 12 weeks in the intervention group ( p = 0.01 , p = 0.004 ) .
-RESULTS	Serum-25 ( OH ) vitamin D was also significantly higher in the vitamin D group compared to the placebo group ( p = 0.02 ) after intervention .
-RESULTS	Although no significant changes in insulin sensitivity , inflammation , blood pressure , lipid profile , or HbA1c were found , we observed borderline ( p between 0.05 and 0.10 ) improvements of insulin secretion , in terms of c-peptide levels , first phase incremental AUC insulin and insulin secretory burst mass .
-CONCLUSIONS	Improvement in vitamin D status does not improve insulin resistance , blood pressure , inflammation or HbA1c , but might increase insulin secretion in patients with established type 2 diabetes .
-
-###25730649
-OBJECTIVE	We investigated acute bone turnover marker ( BTM ) responses to high-intensity resistance exercise with and without whole-body vibration ( WBV ) in young men ( n = 10 ) .
-METHODS	In this randomized crossover study , subjects performed 2 protocols separated by 2-week wash out periods : 1 ) resistance exercise only ( RE ) ( 3 sets 10 repetitions 80 % 1RM for 9 exercises ) ; and 2 ) WBV + RE ( side-alternating vibration platform 5 intermittent , 1-minute bouts 20 Hz , 3.38 mm peak-to-peak displacement followed by RE ) .
-METHODS	Fasting morning blood draws were taken before RE or WBV ( PRE ) , immediately post RE ( IP ) , and 30 minutes post RE ( 30P ) .
-METHODS	WBV + RE also had a blood draw after the WBV exposure ( POST WBV ) .
-METHODS	Blood samples were analyzed for lactate , hematocrit , bone-specific alkaline phosphatase ( Bone ALP , U/L ) , C-terminal telopeptide of type I collagen ( CTX-I , ng/mL ) and tartrate-resistant acid phosphatase 5b ( TRAP5b , U/L ) .
-RESULTS	Lactate , hematocrit , and Bone ALP significantly increased ( p < 0.05 ) IP for both protocols .
-RESULTS	Bone resorption markers did not change during RE only .
-RESULTS	CTX-I significantly decreased POST WBV .
-RESULTS	TRAP5b increased POST WBV , then significantly decreased at 30P .
-CONCLUSIONS	Generally , BTM changes to RE only were not significant when adjusted for hemoconcentration .
-CONCLUSIONS	The WBV stimulus altered bone resorption marker but not bone formation marker responses .
-
-###25381593
-BACKGROUND	Cervical radiculopathy caused by spondylotic foraminal stenosis may require surgical treatment .
-BACKGROUND	Surgical options include anterior cervical foraminotomy and fusion or posterior cervical foraminotomy .
-BACKGROUND	Controversy remains regarding the preferable surgical approach .
-BACKGROUND	Pertinent clinical evidence is limited to low-quality observational reports .
-BACKGROUND	Therefore , treatment decisions are predominantly based on the individual surgeon 's preference and skill .
-BACKGROUND	The study objective is to evaluate the efficacy and safety of posterior foraminotomy in comparison to anterior foraminotomy with fusion for the treatment of spondylotic foraminal stenosis .
-METHODS	This is a multicenter randomized , controlled , parallel group superiority trial .
-METHODS	A total of 88 adult patients are allocated in a ratio of 1:1 .
-METHODS	Sample size and power calculations were performed to detect the minimal clinically important difference of 14 points , with an expected standard deviation of 20 in the primary outcome parameter , Neck Disability Index , with a power of 80 % , based on an assumed maximal dropout rate of 20 % .
-METHODS	Secondary outcome parameters include the Core Outcome Measures Index , which investigates pain , back-specific function , work disability , social disability and patient satisfaction .
-METHODS	Changes in physical and mental health are evaluated using the Short Form-12 ( SF-12 ) questionnaire .
-METHODS	Moreover , radiological and health economic outcomes are evaluated .
-METHODS	Follow-up is performed 3 , 6 , 12 , 24 , 36 , 48 and 60 months after surgery .
-METHODS	Major inclusion criteria are cervical spondylotic foraminal stenosis causing radiculopathy of C5 , C6 or C7 and requiring decompression of one or two neuroforaminae .
-METHODS	Study data generation ( study sites ) and data storage , processing and statistical analysis ( Department of Medical Statistics , Informatics and Health Economics ) are clearly separated .
-METHODS	Data will be analyzed according to the intention-to-treat principle .
-CONCLUSIONS	The results of the ForaC study will provide surgical treatment recommendations for spondylotic foraminal stenosis and will contribute to the understanding of its short - and long-term clinical and radiological postoperative course .
-CONCLUSIONS	This will hopefully translate into improvements in surgical treatment and thus , clinical practice for spondylotic foraminal stenosis .
-BACKGROUND	Current Controlled Trials : ISRCTN82578069 .
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-###24783926
-OBJECTIVE	To explore the effects of five-element music therapy on elderly patients with seasonal affective disorder in a Chinese nursing home .
-METHODS	The patients ( n = 50 ) were recruited from a Shijingshan district nursing home in Beijing , China .
-METHODS	They were randomly assigned to two groups , a treatment group and a control group , with 25 participants in each group .
-METHODS	The patients received music therapy for 1-2 h each week over an 8-week period .
-METHODS	The music therapy involved four phases : introduction , activities , listening to the Chinese five-element music , and a concluding phase .
-METHODS	The participants in the control group did not listen to the five-element music .
-METHODS	This study consisted of two parts : ( a ) a qualitative study that used focus groups to understand the feelings of the patients with seasonal affective disorder ; ( b ) a quantitative study that involved administration of the self-rating depression scale ( SDS ) and Hamilton depression scale ( HAMD ) before and after treatment .
-RESULTS	( a ) Qualitative analysis results : strength derived from the five-element group music therapy and emotional adjustment .
-RESULTS	The five-element group music therapy can reduce patients ' psychological distress and let them feel inner peace and enhance their life satisfaction .
-RESULTS	( b ) No significant difference in SDS and HAMD scores was found between the two groups ( P > 0.05 ) prior to treatment .
-RESULTS	After treatment , the mean SDS score of the control group was 49.9 + / - 18.8 , while the treatment group 's score was 40.2 + / - 18.1 .
-RESULTS	The HAMD score of the control group was 11.2 + / -3.1 , and the treatment group 's score was 8.8 + / - 4.9 .
-RESULTS	Following 8 weeks of music therapy , the SDS and HAMD scores of the treatment group were significantly lower than those for the control group ( P < 0.05 ) .
-CONCLUSIONS	Five-element music therapy alleviated the symptoms of seasonal affective disorder in the elderly patients .
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-###25764615
-BACKGROUND	Intubation in patients with suspected cervical spine injury must be cautiously performed to avoid any further neurologic trauma .
-BACKGROUND	Several intubation techniques have been introduced to minimize cervical spine motion such as the use of the videolaryngoscope .
-OBJECTIVE	The present study aims to compare the movement of the cervical spine during intubation by using McGrath series 5 videolaryngoscope ( MGL ) and that of the conventional Macintosh laryngoscope from cinefluoroscopic imaging .
-METHODS	Twenty-two patients undergoing elective orthopedic surgery that did not involve cervical spine procedure and required general anesthesia were recruited into the study .
-METHODS	All patients were randomized either to have intubation with MGL ( n = 11 ) or Macintosh laryngoscope ( n = 11 ) in a neutral position with manual in-line stabilization ( MILS ) .
-METHODS	The primary outcome was the cervical vertebral angle changes pre - and post-intubation , measured by cinefluoroscopy .
-METHODS	The number of intubation attempts , the laryngoscopic view , the time to intubation , and the incidence ofany complications were recorded as well .
-RESULTS	Eleven patients were included in each group without any exclusion from the study .
-RESULTS	The cervical vertebral angle changes pre - and post-intubation with the MGL was less than with the Macintosh laryngoscope at C3/4 ( 2.00 vs. 4.27 degrees , respectively ; p-value = 0.034 ) and the cumulative changes of all cervical spine levels ( 9.18 vs. 17.18 degrees , respectively ; p-value = 0.017 ) .
-RESULTS	However , the time to intubation with the MGL was longer ( 35.07 vs. 23.21 seconds , p-value = 0.004 ) , the laryngoscope view was better .
-RESULTS	There were no statistically significant differences in the intubation success rate , the number of attempts , and the incidence of complications .
-CONCLUSIONS	Orotracheal intubation with MGL provided less cervical spine motion and improved visualization of the vocal cords , without causing adverse consequences as compared with Macintosh laryngoscope and MILS .
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-###25015544
-BACKGROUND	Protease inhibitor monotherapy is associated with more frequent episodes of viral rebounds above 50 copies/mL than triple therapy .
-OBJECTIVE	To evaluate if , compared to triple-drug therapy , protease inhibitor monotherapy is associated with increased levels of inflammatory/procoagulant markers and more frequent plasma residual viremia detection .
-METHODS	In this cross-sectional study , we included patients treated for 1 year with darunavir/ritonavir or lopinavir/ritonavir as monotherapy ( n = 72 ) or with two nucleos ( t ) ides ( n = 74 ) .
-METHODS	All samples were tested for CRP , IL-6 , fibrinogen and D-dimer .
-METHODS	Residual viremia was determined using an ultrasensitive qualitative nested-PCR of the HIV pol gene with a limit of detection of 1 copy of HIV-RNA .
-RESULTS	We found no differences in levels of inflammatory/procoagulant markers or in the proportion of patients with plasma residual viremia detection by treatment group .
-CONCLUSIONS	The long-term treatment with protease inhibitor monotherapy in the setting of routine clinical practice is not associated with a higher prevalence of plasma residual viremia or more elevated inflammatory/procoagulant markers levels than triple drug therapy .
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-###24944057
-BACKGROUND	There is limited evidence with regard to the effect of different sources of protein on appetite during weight loss .
-BACKGROUND	Vegetarian and meat-based high-protein diets may have contrasting effects on appetite and biomarkers of protein-induced satiety .
-OBJECTIVE	The aim was to assess appetite response to meat or vegetarian high-protein weight-loss ( HPWL ) diets in obese men to monitor plasma amino acid profile and gut peptide response as potential satiety biomarkers .
-METHODS	Twenty obese [ body mass index ( in kg/m ) : 34.8 ] men participated in a dietary intervention study .
-METHODS	After 3 d of a maintenance diet , they were provided in a crossover design with either a vegetarian HPWL ( Soy-HPWL ) or a meat-based HPWL ( Meat-HPWL ) diet for 2 wk .
-METHODS	Both diets comprised 30 % protein , 30 % fat , and 40 % carbohydrate , provided to measured resting metabolic rate .
-METHODS	Body weight and the motivation to eat were measured daily .
-METHODS	Plasma satiety biomarkers were collected during a test-meal challenge ( 5 h ) at the end of each diet period .
-RESULTS	Over the 2 wk , subjects lost , on average , 2.41 and 2.27 kg with consumption of the Soy - and Meat-HPWL diets , respectively [ P = 0.352 ; SE of the difference ( SED ) : 0.1 ] .
-RESULTS	ANOVA confirmed that subjectively rated hunger ( P = 0.569 ; SED : 3.8 ) , fullness ( P = 0.404 ; SED : 4.1 ) , desire to eat ( P = 0.356 ; SED : 3.7 ) , preservation of lean body mass ( P = 0.334 ; SED : 0.2 ) , and loss of percentage fat mass ( P = 0.179 ; SED : 0.2 ) did not differ between the 2 HPWL diets .
-RESULTS	There were differences in absolute concentrations of ghrelin and peptide YY between the 2 HPWL diets , although the response as net area under the curve was not different .
-CONCLUSIONS	Appetite control and weight loss were similar for both HPWL diets .
-CONCLUSIONS	Gut hormone profile was similar between the diets , which suggests that vegetarian diets can be as effective as meat-based diets for appetite control during weight loss .
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-###24326812
-BACKGROUND	Alveolar osteitis ( AO ) is a commonly seen post-operative complication during the wound-healing period after permanent tooth extraction or surgical removal of impacted third molar teeth .
-OBJECTIVE	The aim of this clinical study was to evaluate the effects of administration of the topical hemostatic agent Ankaferd Blood Stopper ( ABS ) into the socket on AO formation after impacted mandibular third molar extraction .
-METHODS	Bilaterally , 100 half-impacted mandibular third molars were extracted in 50 patients .
-METHODS	Then , 1.0 mL ABS was administered to achieve hemostasis in one half of the sockets and as a control , the other half was irrigated with 1.0 mL physiological serum after surgery .
-RESULTS	There was no statistically significant difference in terms of AO formation ( P > 0.05 ) between the extraction sites .
-RESULTS	However , the postoperative pain in ABS administration sites was higher than in the other sites for the first 2 days after surgery ( P < 0.05 ) .
-CONCLUSIONS	The results showed that ABS administration did not increase the incidence of AO formation .
-CONCLUSIONS	Thus , ABS can be used safely for hemostasis after impacted mandibular third molar surgery .
-
-###24748531
-OBJECTIVE	To determine the effects of co-ingesting caffeine ( CAF ) and carbohydrate ( CHO ) on high-intensity intermittent sprints ( HIS ) performance and physiological responses .
-METHODS	Twelve active males underwent 4 interventions at least 7days apart in a randomized , double-blind , placebo-controlled , balanced trial .
-METHODS	A meal contained 65 % CHO was provided 2h before the HIS test .
-METHODS	Participants ingested the placebo ( PLA ) or CAF ( 6mgkg ( -1 ) BW ) 1h before taking an HIS test , and ingested a PLA or CHO solution ( 0.8 gkg ( -1 ) BW ) before undergoing the testing protocol .
-METHODS	The HIS protocol comprised ten sets of 54-s sprints on a cycle ergometer with a 2-min recovery between each set .
-RESULTS	There was no significant difference between peak power output and mean power output between trials ( p > 0.05 ) .
-RESULTS	Compared with PLA , CAF+CHO resulted in a 5.2 % reduction in total work , corresponding to a 24.7-25 .7 % increase in fatigue at the end stage of the HIS .
-RESULTS	The administration of CAF+CHO supplementation also resulted in an 11.1 % increase in blood lactate , and elevated blood glucose concentrations throughout HIS testing compared with PLA ( p < 0.05 ) .
-RESULTS	Cortisol concentrations also increased with CAF+CHO intake compared with PLA ; however , there was no significant effect of CAF+CHO supplementation on testosterone concentrations .
-CONCLUSIONS	Co-ingestion of CAF and CHO did not improve high-intensity sprint cycling performance or reduce fatigue in active males .
-CONCLUSIONS	Moreover , combined CAF and CHO supplementation might facilitate catabolism during prolonged high-intensity intermittent exercise .
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-###25902326
-BACKGROUND	Transversus abdominis plane block ( TAPB ) has emerged as a safe and effective regional anesthesia technique for providing postoperative lower abdominal analgesia .
-BACKGROUND	Complications associated with TAPB are rare and pose a lower overall risk to the patient receiving a TAPB versus a caudal block , which is considered the gold standard for pediatric lower abdominal regional anesthesia .
-BACKGROUND	Our study hypothesis was that TAPB would initially be equivalent to caudal block in providing postoperative pain control but would also show improved pain relief beyond the anticipated caudal duration .
-METHODS	This study was a double-blinded randomized controlled trial .
-METHODS	Forty-five children between the ages of 1 and 9 undergoing bilateral ureteral reimplantation surgery through a low transverse incision were enrolled .
-METHODS	Narcotic requirement , pain scores ( FLACC/Wong-Baker FACES ) , episodes of emesis , and antispasmodic requirement were recorded in the postanesthesia care unit ( PACU ) and at 6-hour intervals for 24 hours from the time of block placement .
-METHODS	Our protocol used a multimodal approach toward pain management in all children , including randomized regional technique , scheduled ketorolac , morphine as needed , and the antispasmodic , oxybutynin , as needed .
-RESULTS	Morphine requirement showed no statistical difference during the initial 12 hours ( all P 0.68 at PACU , 6 and 12 hours ) .
-RESULTS	However , at 24 hours those patients randomized to receive the TAPB required less cumulative morphine than the caudal group ( 0.05 mg/kg 0.06 vs 0.09 mg/kg 0.07 , P = 0.03 ) .
-RESULTS	There was a trend toward fewer episodes of emesis in the TAPB group which reached statistical significance at 18 and 24 hours ( 6 vs 1 episodes , P = 0.03 ; and 9 vs 2 episodes , P = 0.02 ) .
-RESULTS	Pain scores ( 0-10 ) were higher in the TAPB group in the PACU ( 3.46 2.69 vs 1.71 2.1 , P = 0.02 ) , but there were no significant differences at all subsequent time points ( all P 0.10 ) .
-RESULTS	The TAPB group also had a higher requirement for the bladder antispasmodic oxybutynin at 24 hours ( 0.49 0.58 vs 0.28 0.17 , P = 0.003 ) .
-CONCLUSIONS	TAPB provided superior analgesia compared with the caudal block at 6 to 24 hours after block placement , as demonstrated by a statistically significant decrease in cumulative opioid requirement , which was the primary end point .
-CONCLUSIONS	The lower incidence of emesis in the TAPB group likely reflected the decreased opioid consumption .
-CONCLUSIONS	Although TAPB appears to be less effective than the caudal block in preventing viscerally mediated bladder spasms , as evidenced by the higher PACU pain scores and increased oxybutynin requirement at 24 hours , this effect may be counteracted in future clinical practice by scheduled administration of the antispasmodic medications .
-CONCLUSIONS	Considering the overall safety advantages of the TAPB over the caudal block , this should be considered a preferred regional technique for lower abdominal surgeries .
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-###24782115
-BACKGROUND	We investigated the effects of anakinra , an interleukin-1 receptor antagonist , on coronary and left ventricular function in coronary artery disease ( CAD ) patients with rheumatoid arthritis .
-RESULTS	In a double-blind crossover trial , 80 patients with rheumatoid arthritis ( 60 with CAD and 20 without ) were randomized to a single injection of anakinra or placebo and after 48 hours to the alternative treatment .
-RESULTS	At baseline and 3 hours after treatment , we assessed ( 1 ) flow-mediated dilation of brachial artery ; ( 2 ) coronary flow reserve , ejection fraction , systemic arterial compliance , and resistance by echocardiography ; ( 3 ) left ventricular global longitudinal and circumferential strain , peak twisting , untwisting velocity by speckle tracking ; and ( 4 ) interleukin-1 , nitrotyrosine , malondialdehyde , protein carbonyl , and Fas/Fas ligand levels .
-RESULTS	At baseline , patients with CAD had 3-fold higher interleukin-1 , protein carbonyl , higher nitrotyrosine , malondialdehyde , and Fas/Fas ligand than non-CAD ( P < 0.05 ) .
-RESULTS	After anakinra , there was a greater improvement of flow-mediated dilation ( 574 % versus 475 % ) , coronary flow reserve ( 374 % versus 292 % ) , arterial compliance ( 2018 % versus 217 % ) , resistance ( -1119 % versus 921 % ) , longitudinal strain ( 335 % versus 182 % ) , circumferential strain ( 225 % versus 135 % ) , peak twisting ( 305 % versus 125 % ) , untwisting velocity ( 235 % versus 135 % ) , ejection fraction ( 125 % versus 0.55 % ) , apoptotic and oxidative markers , and , in particular , of protein carbonyl ( 3520 % versus 149 % ) in CAD than in non-CAD patients ( P < 0.01 ) .
-RESULTS	No changes in the examined markers were observed after placebo .
-CONCLUSIONS	Interleukin-1 inhibition causes a greater improvement in endothelial , coronary aortic function in addition to left ventricular myocardial deformation and twisting in rheumatoid arthritis patients with CAD than in those without .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01566201 .
-
-###25060825
-BACKGROUND	Preoperative short-term radiotherapy ( PRT ) in combination with total mesorectal excision ( TME ) has shown to improve local control in rectal cancer treatment , however without a survival benefit and at the cost of increased morbidity .
-BACKGROUND	The current study investigates the long-term health-related quality of life ( HRQL ) of patients 14 years after treatment in the Dutch TME trial .
-METHODS	In the TME trial ( 1996-1999 ) 1530 Dutch patients with rectal cancer were treated with TME and randomly assigned to PRT ( 5 5 Gy ) .
-METHODS	In 2012 HRQL was evaluated in surviving patients ( n = 606 ) using a questionnaire combining EORTC QLQ-C30 , EORTC QLQ-CR29 and additional questions .
-RESULTS	Results were obtained from 478 patients ( 82 % ) , with a median follow up of 14 years .
-RESULTS	PRT+TME patients without stoma reported more faecal leakage and higher stool frequency , resulting in increased need of pads .
-RESULTS	Furthermore , irradiated males reported more erection problems .
-RESULTS	However , radiotherapy did not have negative effects on overall functioning .
-RESULTS	Compared with Dutch population , patients in both treatment arms reported a small decrease in overall functioning and males reported less sexual activity , interest and enjoyment and more erection difficulties .
-RESULTS	Irradiated females reported more vaginal dryness and more pain at intercourse compared with Dutch population .
-CONCLUSIONS	Long-term HRQL evaluation shows that treatment-related symptoms are still present 14 years after treatment for rectal cancer .
-CONCLUSIONS	Radiotherapy increased bowel dysfunction in patients without stoma .
-CONCLUSIONS	Compared with the Dutch population , both groups reported increased sexual dysfunction .
-CONCLUSIONS	Despite these treatment-related symptoms , there was no difference in overall functioning and global health between TME and PRT+TME .
-
-###24255130
-OBJECTIVE	We investigated the temporal changes in circulating levels of markers of extracellular cardiac matrix ( ECCM ) turnover and their relationship with infarct size ( IS ) , ejection fraction ( EF ) , and left ventricular ( LV ) volumes , determined by serial cardiac magnetic resonance ( CMR ) imaging in patients with first-time ST-elevation myocardial infarction ( STEMI ) .
-RESULTS	Forty-two patients with a first-time STEMI , successfully revascularized by primary percutaneous coronary intervention ( pPCI ) had serum samples taken prior to pPCI , 2 , 7 days , 2 months , and 1 year following STEMI for the analysis of the markers of collagen synthesis , and collagen degradation .
-RESULTS	Late enhancement and cine CMR was performed on Days 2 , 7 , 2 months , and 1-year post-STEMI .
-RESULTS	There was a significant increase in type I collagen degradation following STEMI that was not accompanied by an increase in collagen type I synthesis until 2 months and 1 year .
-RESULTS	In contrast to the delay in type I collagen synthesis , there was an immediate increase in type III collagen synthesis that was sustained for 1 year .
-RESULTS	N-terminal procollagen type I levels assessed prior to pPCI were predictive of adverse LV remodelling at all CMR time-points .
-CONCLUSIONS	Our findings indicate a net type I collagen breakdown in the first week following STEMI compensated by an early increase in collagen type III synthesis .
-CONCLUSIONS	There is an increase in both type I and III collagen synthesis markers at 2 months and 1 year , indicating a persistent increase in collagen turnover even in these apparently successfully treated patients .
-
-###24338461
-OBJECTIVE	Virtually all early cases of knee osteoarthritis have degenerative medial meniscus lesions accompanying the chondral defects on MRI .
-OBJECTIVE	It is difficult to determine if the symptoms are caused by the unstable meniscus or by osteoarthritis , hence unclear guidance towards treatment .
-OBJECTIVE	We , therefore , aimed to determine the clinical improvement following arthroscopic meniscectomy compared to intraarticular administration of corticosteroids for degenerative ruptures of the medial meniscus in the presence of early stage medial compartment knee osteoarthritis .
-METHODS	We included 120 consecutive cases of nontraumatic symptomatic knees which had degenerative lesions of the medial compartment ( cartilage and meniscus ) on MRI 's .
-METHODS	They were randomized to receive either intraarticular steroid injection or arthroscopic debridement .
-METHODS	We also analyzed the correlation between BMI , age , gender , MRI , intraoperative aspect of the meniscus and cartilage and clinical improvement using the Oxford Knee Score up to one year .
-METHODS	At one month there was significant improvement of the scores for all the examined cases .
-METHODS	Also at one month , the arthroscopic group performed better in terms of symptom improvement .
-METHODS	This was maintained for 79 % of the knees in the arthroscopic group and 61 % in the intraarticular steroid injection respectively , out of those available for follow up at one year .
-RESULTS	At one month , symptoms reappeared for 12 patients in the steroid group and 7 in the arthroscopy respectively .
-RESULTS	Gender and age did not correlate with treatment , whereas extrusion of the meniscus , bone marrow edema , duration of the clinical symptoms , obesity and a low preoperative score were negative prognostic factors .
-CONCLUSIONS	Degenerative medial meniscal tears , in the presence of osteoarthritis , can only marginally benefit from arthroscopic debridement over intraarticular steroid injections in short term follow up .
-CONCLUSIONS	When considering individual cases , factors become more predictive when analyzed in group .
-
-###25282631
-OBJECTIVE	To assess the efficacy of an exercise program on a whole-body vibration platform ( WBV ) in improving body balance and muscle performance and preventing falls in institutionalized elderly people .
-METHODS	A multicentre randomized parallel assessor-blinded clinical trial was conducted in elderly persons living in nursing homes .
-METHODS	Participants were randomized to an exercise program performed either on a whole body vibratory platform ( WBV plus exercise group ) or on a stationary surface ( exercise group ) .
-METHODS	The exercise program for both groups consisted of static and dynamic exercises ( balance and strength training over a 6-week training period of 3 sessions per week ) .
-METHODS	The frequency applied on the vibratory platform was 30 to 35 Hz and amplitude was 2 to 4 mm .
-METHODS	The primary outcome measurement was static/dynamic body balance .
-METHODS	Secondary outcomes were muscle strength and number of falls .
-METHODS	Efficacy was analyzed on an intention-to-treat basis and per protocol .
-METHODS	The effects of the intervention were evaluated using the t test , Mann-Whitney test , or chi-square test , depending on the type of outcome .
-METHODS	Follow-up measurements were collected 6 weeks and 6 months after randomization .
-RESULTS	A total of 159 participants from 10 centers were included : 81 in the WBV plus exercise group and 78 in the control group .
-RESULTS	Mean age was 82 years , and 67.29 % were women .
-RESULTS	The Tinetti test score showed a significant overall improvement in both groups ( P < .001 ) .
-RESULTS	No significant differences were found between groups at week 6 ( P = .890 ) or month 6 ( P = .718 ) .
-RESULTS	The Timed Up and Go test did not improve ( P = .599 ) in either group over time , and no significant differences were found between groups at week 6 ( P = .757 ) or month 6 ( P = .959 ) .
-RESULTS	Muscle performance results from the 5 Sit-To-Stand tests improved significantly across time ( P = .001 ) , but no statistically significant differences were found between groups at week 6 ( P = .709 ) or month 6 ( P = .841 ) .
-RESULTS	A total of 57 falls ( 35.8 % ) were recorded during the follow-up period , with no differences between groups ( P = .406 ) .
-CONCLUSIONS	Exercise program on a vibratory platform provides benefits similar to those with exercise program on a stationary surface in relation to body balance , gait , functional mobility , and muscle strength in institutionalized elderly people .
-CONCLUSIONS	Longer studies in larger samples are needed to assess falls .
-
-###24800966
-BACKGROUND	Depressive disorders are highly prevalent in the working population and are associated with excessive costs .
-BACKGROUND	The evidence for effective worker-directed interventions for employees with depressive symptoms is limited .
-BACKGROUND	Treating employees with depressive symptoms before sick leave via the Internet could be beneficial and cost saving .
-OBJECTIVE	In this study , we developed and tested the effectiveness of a Web-based guided self-help course for employees with depressive symptoms .
-OBJECTIVE	We report on the posttreatment effectiveness of the intervention .
-METHODS	This study is a two-arm randomized controlled trial comparing a Web-based guided self-help course to care as usual ( CAU ) .
-METHODS	We recruited employees from 6 different companies via the companies ' intranet and posters .
-METHODS	The main inclusion criterion was elevated depressive symptoms as measured by a score of 16 on the Center for Epidemiological Studies Depression scale ( CES-D ) .
-METHODS	The intervention ( Happy@Work ) was based on problem-solving treatment and cognitive therapy and consisted of 6 weekly lessons .
-METHODS	Participants were asked to submit their weekly assignment via the website after completion .
-METHODS	They subsequently received feedback from a coach via the website .
-METHODS	Self-report questionnaires on depressive symptoms ( CES-D ; primary outcome ) , anxiety measured by the Hospital Anxiety and Depression Scale ( HADS ) , burnout measured by the Maslach Burnout Inventory ( MBI ) , and work performance measured by the Health and Work Performance Questionnaire ( HPQ ; secondary outcomes ) were completed at baseline and at posttreatment .
-RESULTS	A total of 231 employees were randomized to either the intervention group ( n = 116 ) or CAU ( n = 115 ) .
-RESULTS	The posttreatment assessment was completed by 171 ( 74.0 % ) participants .
-RESULTS	Both the intervention and the CAU group showed significant improvements in the primary outcome of depressive symptoms , but no differences between the conditions was found ( d = 0.16 , 95 % CI -0.10 to 0.41 , P = .29 ) .
-RESULTS	Significant but small effects in favor of the intervention group were found for anxiety symptoms ( d = 0.16 , 95 % CI -0.09 to 0.42 , P = .04 ) and exhaustion ( d = 0.17 , 95 % CI -0.09 to 0.43 , P = .02 ) .
-CONCLUSIONS	This study showed that a Web-based guided self-help course for employees with depressive symptoms was not more effective in reducing depressive symptoms among employees than CAU .
-CONCLUSIONS	Large improvements in depressive symptoms in the CAU group were unforeseen and potential explanations are discussed .
-
-###24905492
-OBJECTIVE	Chronic hepatitis C virus ( HCV ) infection is characterised by a failure of virus-specific CD8 + T cells that is mainly caused by viral escape and T cell exhaustion .
-OBJECTIVE	Constant antigen stimulation has been suggested to contribute to HCV-specific CD8 + T cell exhaustion .
-OBJECTIVE	However , IFN-based therapies failed to recover HCV-specific CD8 + T cell function suggesting that the damage to CD8 + T cells may be permanent even after antigen removal .
-OBJECTIVE	It was therefore the objective of this study to analyse the impact of inhibition of ongoing viral replication by IFN-free therapy with direct acting antivirals ( DAA ) on the phenotype and function of HCV-specific CD8 + T cells .
-METHODS	Virus-specific CD8 + T cells obtained from a patient cohort of 51 previously untreated chronically infected patients undergoing IFN-free therapy with a combination of faldaprevir ( a protease inhibitor ) and deleobuvir ( a non-nucleoside polymerase inhibitor ) with or without ribavirin were analysed ex vivo and after in vitro expansion at baseline , wk4 , wk 12 , and after treatment .
-RESULTS	Our results show the rapid restoration of proliferative HCV-specific CD8 + T cells in the majority of patients with SVR12 within 4 weeks of therapy suggesting that IFN-free therapy mediated antigen removal may restore CD8 + T cell function .
-CONCLUSIONS	This study indicates a specific restoration of proliferative HCV-specific CD8 + T cells under IFN-free therapy .
-CONCLUSIONS	This is in contrast to PegIFN-based therapies that have been shown not to restore T cell function during and after chronic infection .
-
-###25293442
-OBJECTIVE	Obesity is associated with metabolic dysfunctions , which may be mediated by changes in adipose tissue signaling factors .
-OBJECTIVE	These molecules are denoted as Adipose Tissue Generated Mediators of CardioVascular Risk ( ATGMCVR ) here , and include leptin , adiponectin , C-reactive protein ( CRP ) , interleukin 6 ( IL-6 ) , tumor necrosis factor alpha ( TNF ) , and plasminogen activator inhibitor 1 ( PAI-1 ) .
-OBJECTIVE	This study examined the effect of a weight loss program on ATGMCVR in obese adults with prediabetes .
-METHODS	Subjects were randomized to usual care ( UC ; n = 15 ) or lifestyle weight loss groups ( LWL ; n = 15 ) .
-METHODS	LWL was a community-based weight loss intervention to promote physical activity and healthy eating .
-METHODS	ATGMCVR at 1-year were compared between groups by analysis of covariance ; baseline value of the mediator was the covariate .
-METHODS	Baseline means for ATGMCVR were compared between those with ( n = 21 ) and without ( n = 9 ) metabolic syndrome ( MetS ) .
-RESULTS	At baseline , subjects were 589 ( SD ) years , 70 % female , with a BMI of 344kg/m ( 2 ) .
-RESULTS	One-year weight loss ( % ) was 7.86.0 % for LWL and 1.74.5 % for UC .
-RESULTS	Group differences at 1-year were noted ( adjusted means [ 95 % CI ] for UC and LWL , respectively ) for adiponectin ( 8526.3 [ 7397.7 , 9827 ] ; 10,870.9 [ 9432.0 , 12,529.3 ] ng/ml ; p = 0.02 ) , leptin ( 30.4 [ 26.1 , 35.4 ] ; 23.7 [ 20.3 , 27.5 ] ng/ml ; p = 0.02 ) , IL-6 ( 0.4 [ 0.3 , 0.5 ] ; 0.2 [ 0.1 , 0.2 ] pg/ml ; p = 0.001 ) , and PAI-1 ( 50 [ 42.7 , 58.7 ] ; 36.2 [ 30.8 , 42.4 ] pg/ml ; p = 0.01 ) .
-RESULTS	No differences in baseline ATGMCVR were seen between subjects with and without MetS .
-CONCLUSIONS	These findings suggest ATGMCVR can be improved with weight loss ; larger studies are needed to determine if improvements in metabolic dysfunction are related to changes in ATGMCVR .
-
-###25127170
-BACKGROUND	The blood glucose-lowering effects of - glucan from oats and barley depend on the amounts consumed and their rheological properties .
-BACKGROUND	This has been recently challenged with growing evidence that the food matrix may also be an important factor in predicting its physiological response .
-OBJECTIVE	The objective of this study was to examine the effects of varying doses of - glucan from oats and barley and added to a snack bar on postprandial glycemia .
-METHODS	In a randomized crossover study , 12 healthy males and females consumed one of 8 snack bars containing 0 ( control ) , 1.5 , 3 , and 6 g of - glucan derived from oats or barley or 3 white bread controls .
-METHODS	All treatments contained 50 g of available carbohydrate .
-METHODS	Blood glucose concentrations were measured after ingestion of the treatments over 2 hours .
-RESULTS	Incorporation of 1.5 to 6 g of - glucan into snack bars had no additional glucose-lowering benefits irrespective of dose and source compared to the control bars ( 0 g - glucan ) , suggesting that both the solid food matrix and composition of the bars may play a role in their effects on glycemic response .
-RESULTS	All bars reduced blood glucose area under the curve ( AUC ) by an average of 25 % ( p < 0.05 ) compared to the mean of the 3 white bread controls .
-CONCLUSIONS	Adding - glucan from oats and barley to the snack bar formulation used in this study did not yield any additional benefits beyond the glucose-lowering effects of the snack bars themselves .
-
-###24950277
-OBJECTIVE	A randomized clinical trial assessing the difference in quality of life and clinical outcomes between delayed and simultaneous phlebectomies in the context of endovenous truncal vein ablation .
-BACKGROUND	Endovenous ablation has replaced open surgery as the treatment of choice for truncal varicose veins .
-BACKGROUND	Timing of varicosity treatment is controversial with delayed and simultaneous pathways having studies advocating their benefits .
-BACKGROUND	A previous small randomized study has shown improved outcomes for simultaneous treatment .
-METHODS	Patients undergoing local anesthetic endovenous thermal ablation were randomized to either simultaneous phlebectomy or delayed varicosity treatment .
-METHODS	Patients were reviewed at 6 weeks , 6 months , and 1 year with clinical and quality of life scores completed , and were assessed at 6 weeks for need for further varicosity intervention , which was completed with either ultrasound-guided foam sclerotherapy or local anesthetic phlebectomy .
-METHODS	Duplex ultrasound assessment of the treated trunk was completed at 6 months .
-RESULTS	101 patients were successfully recruited and treated out of 221 suitable patients from a screened population of 393 .
-RESULTS	Patients in the simultaneous group ( n = 51 ) showed a significantly improved Venous Clinical Severity Score at all time points , 36 % of the delayed group required further treatment compared with 2 % of the simultaneous group ( P < 0.001 ) .
-RESULTS	There were no deep vein thromboses , with 1 superfificial venous thrombosis in each group .
-CONCLUSIONS	Combined endovenous ablation and phlebectomy delivers improved clinical outcomes and a reduced need for further procedures , as well as early quality of life improvements .
-
-###24449235
-OBJECTIVE	Although guidelines recommend in-person counseling before BRCA1/BRCA2 gene testing , genetic counseling is increasingly offered by telephone .
-OBJECTIVE	As genomic testing becomes more common , evaluating alternative delivery approaches becomes increasingly salient .
-OBJECTIVE	We tested whether telephone delivery of BRCA1/2 genetic counseling was noninferior to in-person delivery .
-METHODS	Participants ( women age 21 to 85 years who did not have newly diagnosed or metastatic cancer and lived within a study site catchment area ) were randomly assigned to usual care ( UC ; n = 334 ) or telephone counseling ( TC ; n = 335 ) .
-METHODS	UC participants received in-person pre - and post-test counseling ; TC participants completed all counseling by telephone .
-METHODS	Primary outcomes were knowledge , satisfaction , decision conflict , distress , and quality of life ; secondary outcomes were equivalence of BRCA1/2 test uptake and costs of delivering TC versus UC .
-RESULTS	TC was noninferior to UC on all primary outcomes .
-RESULTS	At 2 weeks after pretest counseling , knowledge ( d = 0.03 ; lower bound of 97.5 % CI , -0.61 ) , perceived stress ( d = -0.12 ; upper bound of 97.5 % CI , 0.21 ) , and satisfaction ( d = -0.16 ; lower bound of 97.5 % CI , -0.70 ) had group differences and confidence intervals that did not cross their 1-point noninferiority limits .
-RESULTS	Decision conflict ( d = 1.1 ; upper bound of 97.5 % CI , 3.3 ) and cancer distress ( d = -1.6 ; upper bound of 97.5 % CI , 0.27 ) did not cross their 4-point noninferiority limit .
-RESULTS	Results were comparable at 3 months .
-RESULTS	TC was not equivalent to UC on BRCA1/2 test uptake ( UC , 90.1 % ; TC , 84.2 % ) .
-RESULTS	TC yielded cost savings of $ 114 per patient .
-CONCLUSIONS	Genetic counseling can be effectively and efficiently delivered via telephone to increase access and decrease costs .
-
-###24872892
-OBJECTIVE	To evaluate the effectiveness of a 12-month multicomponent obesity prevention intervention .
-OBJECTIVE	Setting .
-OBJECTIVE	9 elementary schools in Santiago , Chile .
-OBJECTIVE	Subjects .
-OBJECTIVE	6-8y old low-income children ( N = 1474 ) .
-METHODS	Randomized controlled study ; 5 intervention/4 control schools .
-METHODS	We trained teachers to deliver nutrition contents and improve the quality of PE classes .
-METHODS	We determined % healthy snacks brought from home , children 's nutrition knowledge , nutritional status , duration of PE classes , and % time in moderate/vigorous activity ( MVA ) .
-METHODS	Effectiveness was determined by comparing BMI Z between intervention and control children using PROCMIXED .
-RESULTS	% obesity increased in boys from both types of schools and in girls from control schools , while decreasing in girls from intervention schools ( all nonsignificant ) .
-RESULTS	% class time in MVA declined ( 24.5-16 .2 ) while remaining unchanged ( 24.8-23 .7 % ) in classes conducted by untrained and trained teachers , respectively .
-RESULTS	In boys , BMI Z declined ( 1.33-1 .24 ) and increased ( 1.22-1 .35 ) in intervention and control schools , respectively .
-RESULTS	In girls , BMI Z remained unchanged in intervention schools , while increasing significantly in control schools ( 0.91-1 .06 , P = 0.024 ) .
-RESULTS	Interaction group time was significant for boys ( P < 0.0001 ) and girls ( P = 0.004 ) .
-CONCLUSIONS	This intervention was effective in controlling obesity , but not preventing it .
-CONCLUSIONS	Even though impact was small , results showed that when no intervention is implemented , obesity increases .
-
-###24220007
-BACKGROUND	Although the potential benefits of 3-dimensional ( 3-D ) vs 2-dimensional ( 2-D ) and high-definition ( HD ) vs standard-definition ( SD ) endoscopic visualization have long been recognized in other surgical fields , such endoscopes are generally considered too large and bulky for use within the brain .
-BACKGROUND	The recent development of 3-D and HD neuroendoscopes may therefore herald improved depth perception , better appreciation of anatomic details , and improved overall surgical performance .
-OBJECTIVE	To compare simultaneously the effectiveness of 3-D vs 2-D and HD vs SD neuroendoscopy .
-METHODS	Ten novice neuroendoscopic surgeons were recruited from a university hospital .
-METHODS	A preclinical randomized crossover study design was adopted to compare 3-D vs 2-D and HD vs SD neuroendoscopy .
-METHODS	The primary outcomes were time to task completion and accuracy .
-METHODS	The secondary outcomes were perceived task workload using the NASA ( National Aeronautics and Space Administration ) Task Load Index and subjective impressions of the endoscopes using a 5-point Likert scale .
-RESULTS	Time to task completion was significantly shorter when using the 3-D vs the 2-D neuroendoscopy ( P = .001 ) , and accuracy of probe placement was significantly greater when using the HD vs the SD neuroendoscopy ( P = .009 ) .
-RESULTS	We found that 3-D endoscopy significantly improved perceived depth perception ( P < .001 ) , HD endoscopy significantly improved perceived image quality ( P < .001 ) , and both improved participants ' overall impression ( P < .001 ) .
-CONCLUSIONS	Three-dimensional neuroendoscopy and HD neuroendoscopy have differing but complementary effects on surgical performance , suggesting that neither alone can completely compensate for the lack of the other .
-CONCLUSIONS	There is therefore strong preclinical evidence to justify 3-D HD neuroendoscopy .
-
-###24935282
-OBJECTIVE	To present the safety and efficacy of intravitreal implants releasing 0.2 g/day fluocinolone acetonide ( FAc ) in patients with chronic versus nonchronic diabetic macular edema ( DME ) .
-OBJECTIVE	To assess ocular characteristics , anatomic changes , and re-treatment and ancillary therapies that may explain the differential treatment effect seen with intravitreal implants releasing FAc 0.2 g/day in patients with chronic and nonchronic DME .
-OBJECTIVE	An overall benefit-to-risk assessment for the FAc 0.2-g / day and FAc 0.5-g / day doses has been reported previously .
-METHODS	Preplanned subgroup analysis of chronic ( duration of diagnosis , 3 years ) and nonchronic ( duration of diagnosis , < 3 years ) DME in patients from 2 randomized , sham injection-controlled , double-masked , multicenter clinical trials .
-METHODS	Patients with persistent DME despite 1 or more macular laser treatment were randomized 1:2:2 to sham injection ( n = 185 ) , FAc 0.2 g/day ( n = 375 ) , or FAc 0.5 g/day ( n = 393 ) .
-METHODS	Patients received study drug or sham injection and after 6 weeks were eligible for rescue laser .
-METHODS	Based on re-treatment criteria , additional masked study drug could be given after 1 year .
-METHODS	Percentage of patients with improvement of 15 letters or more from baseline .
-METHODS	Secondary outcomes included other parameters of visual function and foveal thickness .
-RESULTS	At month 36 , the difference between FAc 0.2 g/day and sham control in the percentage of patients who gained 15 letters or more was significantly greater in chronic DME patients ( FAc 0.2 g/day , 34.0 % vs. sham , 13.4 % ; P < 0.001 ) , compared with patients with nonchronic DME ( FAc 0.2 g/day , 22.3 % vs. sham , 27.8 % ; P = 0.275 ) .
-RESULTS	The greater response in patients with chronic DME was not associated with baseline ocular characteristics , changes in anatomic features , or differences in re-treatment or ancillary therapies .
-RESULTS	The ocular adverse event profile for FAc 0.2 g/day was similar regardless of DME duration .
-CONCLUSIONS	This is the first published analysis correlating duration of diagnosis of DME with treatment effect .
-CONCLUSIONS	In patients with chronic DME , FAc 0.2 g/day provides substantial visual benefit for up to 3 years and would provide an option for patients who do not respond to other therapy .
-
-###24856802
-BACKGROUND	Ischemic postconditioning ( PCON ) appears as a potentially beneficial tool in ST-segment elevation myocardial infarction ( STEMI ) .
-BACKGROUND	We evaluated the effect of PCON on microvascular obstruction ( MVO ) in STEMI patients and in an experimental swine model .
-METHODS	A prospective randomized study in patients and an experimental study in swine were carried out in two university hospitals in Spain .
-METHODS	101 consecutive STEMI patients were randomized to undergo primary angioplasty followed by PCON or primary angioplasty alone ( non-PCON ) .
-METHODS	Using late gadolinium enhancement cardiovascular magnetic resonance , infarct size and MVO were quantified ( % of left ventricular mass ) .
-METHODS	In swine , using an angioplasty balloon-induced anterior STEMI model , MVO was defined as the % of area at risk without thioflavin-S staining .
-RESULTS	In patients , PCON ( n = 49 ) in comparison with non-PCON ( n = 52 ) did not significantly reduce MVO ( 0 [ 0-1 .02 ] % vs. 0 [ 0-2 .1 ] % p = 0.2 ) or IS ( 18 13 % vs. 21 14 % , p = 0.2 ) .
-RESULTS	MVO ( > 1 segment in the 17-segment model ) occurred in 12/49 ( 25 % ) PCON and in 18/52 ( 35 % ) non-PCON patients , p = 0.3 .
-RESULTS	No significant differences were observed between PCON and non-PCON patients in left ventricular volumes , ejection fraction or the extent of hemorrhage .
-RESULTS	In the swine model , MVO occurred in 4/6 ( 67 % ) PCON and in 4/6 ( 67 % ) non-PCON pigs , p = 0.9 .
-RESULTS	The extent of MVO ( 10 7 % vs. 10 8 % , p = 0.9 ) and infarct size ( 23 14 % vs. 24 10 % , p = 0.8 ) was not reduced in PCON compared with non-PCON pigs .
-CONCLUSIONS	Ischemic postconditioning does not significantly reduce microvascular obstruction in ST-segment elevation myocardial infarction .
-CONCLUSIONS	Clinical Trial Registration http://www.clinicaltrials.gov .
-CONCLUSIONS	Unique identifier : NCT01898546 .
-
-###24480515
-BACKGROUND	Sub-anesthetic ketamine infusions may benefit a variety of psychiatric disorders , including addiction .
-BACKGROUND	Though ketamine engenders transient alterations in consciousness , it is not known whether these alterations influence efficacy .
-BACKGROUND	This analysis evaluates the mystical-type effects of ketamine , which may have therapeutic potential according to prior research , and assesses whether these effects mediate improvements in dependence-related deficits , 24h postinfusion .
-METHODS	Eight cocaine dependent individuals completed this double-blind , randomized , inpatient study .
-METHODS	Three counter-balanced infusions separated by 48h were received : lorazepam ( 2mg ) and two doses of ketamine ( 0.41 mg/kg and 0.71 mg/kg , with the former dose always preceding the latter ) .
-METHODS	Infusions were followed within 15min by measures of dissociation ( Clinician Administered Dissociative Symptoms Scale : CADSS ) and mystical-type effects ( adapted from Hood 's Mysticism Scale : HMS ) .
-METHODS	At baseline and 24h postinfusion , participants underwent assessments of motivation to stop cocaine ( University of Rhode Island Change Assessment ) and cue-induced craving ( by visual analogue scale for cocaine craving during cue exposure ) .
-RESULTS	Ketamine led to significantly greater acute mystical-type effects ( by HMS ) relative to the active control lorazepam ; ketamine 0.71 mg/kg was associated with significantly higher HMS scores than was the 0.41 mg/kg dose .
-RESULTS	HMS score , but not CADSS score , was found to mediate the effect of ketamine on motivation to quit cocaine 24h postinfusion .
-CONCLUSIONS	These findings suggest that psychological mechanisms may be involved in some of the anti-addiction benefits resulting from ketamine .
-CONCLUSIONS	Future research can evaluate whether the psychoactive effects of ketamine influence improvements in larger samples .
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-###24909188
-BACKGROUND	Although facial hyperhidrosis has been frequently associated with a diminished quality of life , various conservative modalities for its management are still far from satisfactory .
-OBJECTIVE	To evaluate the antiperspirant efficacy and safety of the topical glycopyrrolate on facial hyperhidrosis at specified posttreatment intervals .
-METHODS	Thirty-nine patients with facial hyperhidrosis were enrolled and treated with 2 % topical glycopyrrolate on one-half of the forehead , whereas the other half of the forehead was treated with a placebo .
-METHODS	All patients applied topical glycopyrrolate or placebo once a day for nine successive days .
-METHODS	Each evaluation included weighing sweat and assessing the Hyperhidrosis Disease Severity Scale ( HDSS ) score and any adverse effects .
-RESULTS	Compared with the placebo-treated sides , topical glycopyrrolate-treated sides showed a reduction in the rate of sweat production at the forehead of 25.16 10.30 % ( mean SD ) at 90 min after the first application ( day 1 ) , 29.63 7.74 % at 24 h after the first application ( day 2 ) and 36.68 11.41 % at 24 h after eight additional successive daily applications ( day 10 ) ( all P < 0.025 ) .
-RESULTS	There was a little more decrease in HDSS score with the topical glycopyrrolate-treated half of the forehead , but the difference was not statistically significant ( P > 0.025 ) .
-RESULTS	No serious adverse events were reported during the course of this study .
-RESULTS	Only one patient developed a transient headache after treatment .
-CONCLUSIONS	Topical glycopyrrolate application appears to be significantly effective and safe in reducing excessive facial perspiration .
-
-###25040793
-OBJECTIVE	To examine the association between Mini-Mental State Examination ( MMSE ) score and motor vehicle crash ( MVC ) risk in a large cohort of community-dwelling participants with cardiovascular disease ( CVD ) or diabetes mellitus .
-METHODS	Prospective observational study .
-METHODS	Participants enrolled in the Ongoing Telmisartan Alone and in Combination With Ramipril Global End Point Trial and Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease clinical trial , which included individuals aged 55 and older with CVD or diabetes mellitus .
-METHODS	Totally 17,538 frequent drivers ( defined as driving at least once per week ) who had completed a baseline MMSE .
-METHODS	Involvement in a MVC as the driver .
-RESULTS	Baseline MMSE score was divided into four categories : 30 , 27-29 , 24-26 , and < 24 .
-RESULTS	The median MMSE score was 29 ( interquartile range 27-30 ) , and 726 ( 4.1 % ) has a MMSE score of less than 24 at baseline .
-RESULTS	After a mean follow-up of 4.5 years , 1,068 ( 6.1 % ) participants were drivers in a MVC .
-RESULTS	Lower scores were not associated with future MVCs ( MMSE score 29-27 , hazard ratio ( HR ) = 1.06 , 95 % confidence interval ( CI ) = 0.93-1 .22 ) ; MMSE score 26-24 , HR = 0.96 , 95 % CI = 0.78-1 .19 ; MMSE score < 24 , HR = 0.72 , 95 % CI = 0.50-1 .05 ) on multivariable analysis .
-RESULTS	A MVC within the previous 2 years ( HR = 2.68 , 95 % CI = 2.29-3 .13 ) was the strongest predictor of future MVCs .
-RESULTS	Other clinical factors associated with greater MVC risk were depression , falls within the previous year , sleep apnea , and lower baseline systolic blood pressure .
-CONCLUSIONS	In a population of frequent drivers , the MMSE does not predict MVCs .
-CONCLUSIONS	Other clinical factors have a stronger association with MVC risk .
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-###25906949
-BACKGROUND	Primary dysmenorrhea refers to painful menstrual cramps without pelvic pathology .
-BACKGROUND	The condition is highly prevalent among women and exerts negative effects on their quality of life .
-BACKGROUND	Considering the evidence for anti-inflammatory properties of Boron , the present study aimed to determine the effects of Boron supplementation on the severity and duration of menstrual pain in female university students .
-METHODS	This triple-blind randomized clinical trial study recruited 113 university students .
-METHODS	The participants were matched for the severity and duration of dysmenorrhea and randomly allocated into the case and control groups ( n = 58 and 55 , respectively ) .
-METHODS	The case group consumed 10 mg/day Boron from two days before the menstrual flow until its third day .
-METHODS	The control group received placebo capsules ( similar to those distributed among the cases ) .
-METHODS	All subjects were asked to take the capsules for two consecutive menstrual cycles .
-METHODS	Pain severity ( measured on a visual analog scale ) and duration ( in hours ) were measured at baseline and during the two cycles .
-RESULTS	The two groups had no significant differences in the severity and duration of pain at baseline .
-RESULTS	After the intervention , however , the severity and duration of pain were significantly lower in the case group than in the control group ( P < 0.05 ) .
-CONCLUSIONS	Based on our findings , Boron supplementation can reduce the severity and duration of menstrual pain through exerting anti-inflammatory effects .
-CONCLUSIONS	In order to clarify the effects of Boron on dysmenorrhea , future studies are required to measure the levels of hormones and inflammatory biomarkers .
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-###25559612
-OBJECTIVE	The present study examined the impact of BP from childhood to mid-adulthood on retinal microvascular architecture .
-METHODS	The Cardiovascular Risk in Young Finns Study included children aged 3-18 years , from five Finnish University cities , with participants chosen randomly from the national population registrar from those areas .
-METHODS	The age of participants included in the current analyses in childhood ( 1980 ) ranged from three to nine years and in mid-adulthood ( 2011 ) ranged from 34 to 40 years ( complete data n = 657 ) .
-METHODS	Measures of retinal microvasculature architecture measured in adulthood included diameters , tortuosity , lengths , and LDR .
-RESULTS	Regression analysis showed a strong negative association between childhood systolic BP and adult arteriolar diameter ( standardized regression coefficient [ ] -0.300 ; p < 0.001 ) and with change in systolic BP from childhood to adulthood ( = -0.249 ; p < 0.001 ) .
-RESULTS	For arteriolar tortuosity , there was a strong positive association between childhood systolic BP and adult arteriolar tortuosity ( = 0.154 ; p < 0.001 ) and no association with change in systolic BP from childhood to adulthood ( = 0.072 ; p = 0.110 ) .
-CONCLUSIONS	High BP in childhood and increased BP from childhood to adulthood impacts on retinal microvascular architecture in mid-adulthood .
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-###24853083
-OBJECTIVE	To evaluate quantitative relationships between baseline Q-wave width and 90-day outcomes in ST-segment elevation myocardial infarction ( STEMI ) .
-BACKGROUND	Baseline Q-waves are useful in predicting clinical outcomes after MI .
-METHODS	3589 STEMI patients were assessed from a multi-centre study .
-RESULTS	1156 patients of the overall cohort had pathologic Q-waves .
-RESULTS	The 90-day mortality and the composite of mortality , congestive heart failure ( CHF ) , or cardiogenic shock ( p < 0.001 for both outcomes ) rose as Q-wave width increased .
-RESULTS	After adapting a threshold 40ms for inferior and 20ms for lateral/apical MI in all patients ( n = 3065 ) with any measureable Q-wave we found hazard ratios ( HR ) for mortality ( HR : 2.44 , 95 % confidence interval ( CI ) ( 1.54-3 .85 ) , p < 0.001 ) and the composite ( HR : 2.32 , 95 % CI ( 1.70-3 .16 ) , p < 0.001 ) .
-RESULTS	This improved reclassification of patients experiencing the composite endpoint versus the conventional definition ( net reclassification index ( NRI ) : 0.23 , 95 % CI ( 0.09-0 .36 ) , p < 0.001 ) and universal MI definition ( NRI : 0.15 , 95 % CI ( 0.02-0 .29 ) , p = 0.027 ) .
-CONCLUSIONS	The width of the baseline Q-wave in STEMI adds prognostic value in predicting 90-day clinical outcomes .
-CONCLUSIONS	A threshold of 40ms in inferior and 20ms for lateral/apical MI enhances prognostic insight beyond current criteria .
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-###24565542
-BACKGROUND	The relationship between current asthma symptoms and rescue bronchodilator ( reliever ) use is uncertain , leading to different recommendations about the preferred reliever metric to use when assessing asthma control .
-BACKGROUND	In a 6-month randomized controlled trial of combination budesonide/formoterol as maintenance and reliever therapy versus combination budesonide/formoterol as maintenance treatment with albuterol as reliever , we measured inhaler use by electronic monitoring .
-OBJECTIVE	To determine the agreement between current asthma symptoms and different metrics of albuterol use for patients randomly assigned to maintenance budesonide/formoterol treatment .
-METHODS	Data on albuterol use were extracted for the 7-day period before visit 2 ( at week 3 ) from 150 adult patients with asthma .
-METHODS	Current asthma symptoms were measured by Asthma Control Questionnaire-5 ( ACQ-5 ) score at the clinic visit .
-RESULTS	The number of days of albuterol use , the average number of albuterol actuations/day , and the highest number of albuterol actuations/day in the 1-week period were all positively associated with ACQ-5 score ( r = 0.41-0 .45 , P < .001 ) and had moderate discrimination for well-controlled and not well-controlled asthma ( ACQ-5 scores 0.75 and 1.5 , respectively ) , with receiver operator characteristic area under the curve of 0.80 to 0.82 and 0.70 to 0.77 , respectively .
-RESULTS	Cut points of 3 days of albuterol use , average albuterol use of 1 actuation/day , and highest albuterol use of 4 actuations/day in the 1-week period had 73 % sensitivity and 62 % specificity , 78 % sensitivity and 67 % specificity , and 78 % sensitivity and 66 % specificity , respectively , for predicting an ACQ-5 1.5 .
-CONCLUSIONS	Our findings support the use of the number of days of albuterol use , the average number of albuterol actuations per day , and the highest number of albuterol actuations per day over a 1-week period of observation as comparable markers of current asthma control .
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-###25125679
-BACKGROUND	Tenofovir has been associated with a decrease in bone mineral density ( BMD ) .
-BACKGROUND	However , data on changes in BMD after discontinuing tenofovir are lacking .
-METHODS	We performed a two-centre randomized pilot study in virologically suppressed HIV-infected patients receiving tenofovir with osteopenia/osteoporosis ( OsteoTDF study , ClinicalTrials.gov number NCT 01153217 ) .
-METHODS	Fifty-four patients were randomly assigned to switch from tenofovir to abacavir ( n = 26 ) or to continue with tenofovir ( n = 28 ) .
-METHODS	Changes in lumbar and total hip BMD were evaluated at Week 48 from baseline .
-RESULTS	Five patients discontinued the study ( three from the tenofovir group and two from the abacavir group ) .
-RESULTS	No significant differences were detected between the groups at Week 48 ( P = 0.229 for total hip and P = 0.312 for lumbar spine ) .
-RESULTS	However , hip BMD improved by 2.1 % ( 95 % CI -0.6 to 4.7 ) ( P = 0.043 ) in the abacavir group and 0.7 % ( 95 % CI -0.9 to 2.4 ) ( P = 0.372 ) in the tenofovir group .
-RESULTS	Lumbar spine BMD varied by -0.7 % ( 95 % CI -3.8 to 3.3 ) ( P 0.001 ) in the abacavir group and -1.2 % ( 95 % CI -3.8 to 0.4 ) ( P < 0.001 ) in the tenofovir group .
-CONCLUSIONS	Switching from tenofovir to abacavir led to a slight improvement in femoral BMD although no differences were detected between groups .
-CONCLUSIONS	Larger studies are necessary before firm recommendations can be made on the discontinuation of tenofovir in patients with a low BMD .
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-###25240247
-OBJECTIVE	Binaural interaction can be investigated using auditory evoked potentials .
-OBJECTIVE	A binaural interaction component can be derived from the auditory brainstem response ( ABR-BIC ) and is considered evidence for binaural interaction at the level of the brainstem .
-OBJECTIVE	Although click ABR-BIC has been investigated thoroughly , data on 500 Hz tone-burst ( TB ) ABR-BICs are scarce .
-OBJECTIVE	In this study , characteristics of click and 500 Hz TB ABR-BICs are described .
-OBJECTIVE	Furthermore , reliability of both click and 500 Hz TB ABR-BIC are investigated .
-METHODS	Eighteen normal hearing young adults ( eight women , ten men ) were included .
-METHODS	ABRs were recorded in response to clicks and 500 Hz TBs .
-METHODS	ABR-BICs were derived by subtracting the binaural response from the sum of the monaural responses measured in opposite ears .
-RESULTS	Good inter-rater reliability is obtained for both click and 500 Hz TB ABR-BICs .
-RESULTS	The most reliable peak in click ABR-BIC occurs at a mean latency of 6.06 ms ( SD 0.354 ms ) .
-RESULTS	Reliable 500 Hz TB ABR-BIC are obtained with a mean latency of 9.47 ms ( SD 0.678 ms ) .
-RESULTS	Amplitudes are larger for 500 Hz TB ABR-BIC than for clicks .
-CONCLUSIONS	The most reliable peak in click ABR-BIC occurs at the downslope of wave V. Five hundred Hertz TB ABR-BIC is characterized by a broad positivity occurring at the level of wave V.
-CONCLUSIONS	The ABR-BIC is a useful technique to investigate binaural interaction in certain populations .
-CONCLUSIONS	Examples are bilateral hearing aid users , bilateral cochlear implant users and bimodal listeners .
-CONCLUSIONS	The latter refers to the combination of unilateral cochlear implantation and contralateral residual hearing .
-CONCLUSIONS	The majority of these patients have residual hearing in the low frequencies .
-CONCLUSIONS	The current study suggests that 500 Hz TB ABR-BIC may be a suitable technique to assess binaural interaction in this specific population of cochlear implant users .
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-###24313546
-OBJECTIVE	To evaluate the possible association between pressure pain sensitivity of the chest bone ( PPS ) and cardiovascular physiological factors related to persistent stress in connection with a three-month PPS-guided stress-reducing experimental intervention programme .
-METHODS	Forty-two office workers with an elevated PPS ( 60 arbitrary units ) as a sign of increased level of persistent stress , completed a single-blinded cluster randomized controlled trial .
-METHODS	The active treatment was a PPS ( self-measurement ) - guided stress management programme .
-METHODS	Primary endpoints : Blood pressure ( BP ) , heart rate ( HR ) and work of the heart measured as Pressure-Rate-Product ( PRP ) ; Secondary endpoints : Other features of the metabolic syndrome .
-RESULTS	PPS decreased and changes in PPS after the intervention period were significantly associated with HR , PRP , body mass index ( BMI ) and visceral fat index ( all correlation coefficients > 0.2 , p < 0.05 ) .
-RESULTS	Compared to the control cluster group , the active cluster group obtained a significant reduction in PPS , Low-density lipoprotein ( LDL ) cholesterol and total number of elevated risk factors ( p < 0.05 ) .
-RESULTS	On an individual level , significant and clinically relevant between-group reductions were observed in respect to BP , HR , PRP , total and LDL cholesterol , and total number of elevated risk factors ( p < 0.05 ) .
-CONCLUSIONS	The stress intervention method applied in this study induced a decrease in PPS which was associated with a clinically relevant decrease in resting blood pressure , heart rate , work of the heart and serum cholesterols .
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-###25304365
-BACKGROUND	The low quality of healthcare and the presence of user fees in Burkina Faso contribute to low utilization of healthcare and elevated levels of mortality .
-BACKGROUND	To improve access to high-quality healthcare and equity , national authorities are testing different intervention arms that combine performance-based financing with community-based health insurance and pro-poor targeting .
-BACKGROUND	There is a need to evaluate the implementation of these unique approaches .
-BACKGROUND	We developed a research protocol to analyze the conditions that led to the emergence of these intervention arms , the fidelity between the activities initially planned and those conducted , the implementation and adaptation processes , the sustainability of the interventions , the possibilities for scaling them up , and their ethical implications .
-METHODS	The study adopts a longitudinal multiple case study design with several embedded levels of analyses .
-METHODS	To represent the diversity of contexts where the intervention arms are carried out , we will select three districts .
-METHODS	Within districts , we will select both primary healthcare centers ( n = 18 ) representing different intervention arms and the district or regional hospital ( n = 3 ) .
-METHODS	We will select contrasted cases in relation to their initial performance ( good , fair , poor ) .
-METHODS	Over a period of 18 months , we will use quantitative and qualitative data collection and analytical tools to study these cases including in-depth interviews , participatory observation , research diaries , and questionnaires .
-METHODS	We will give more weight to qualitative methods compared to quantitative methods .
-CONCLUSIONS	Performance-based financing is expanding rapidly across low - and middle-income countries .
-CONCLUSIONS	The results of this study will enable researchers and decision makers to gain a better understanding of the factors that can influence the implementation and the sustainability of complex interventions aiming to increase healthcare quality as well as equity .
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-###25460337
-BACKGROUND	Obesity is a major public health problem for which early preventive interventions are needed .
-BACKGROUND	Large numbers of young children are enrolled in some form of child care program , making these facilities influential environments in children 's development .
-BACKGROUND	Family child care homes ( FCCH ) are a specific type of child care in which children are cared for within the provider 's own residence .
-BACKGROUND	FCCHs serve approximately 1.5 million children in the U.S. ; however , research to date has overlooked FCCH providers and their potential to positively influence children 's health-related behaviors .
-METHODS	Keys to Healthy Family Child Care Homes ( Keys ) is a cluster-randomized controlled trial testing the efficacy of an intervention designed to help providers become healthy role models , provide quality food - and physical activity-supportive FCCH environments , and implement effective business practices .
-METHODS	The intervention is delivered through workshops , home visits , tailored coaching calls , and educational toolkits .
-METHODS	Primary outcomes are child physical activity measured via accelerometry data and dietary intake data collected using direct observation at the FCCH .
-METHODS	Secondary outcomes include child body mass index , provider weight-related behaviors , and observed obesogenic environmental characteristics .
-CONCLUSIONS	Keys is an innovative approach to promoting healthy eating and physical activity in young children .
-CONCLUSIONS	The intervention operates in a novel setting , targets children during a key developmental period , and addresses both provider and child behaviors to synergistically promote health .
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-###24739994
-BACKGROUND	Benign essential blepharospasm ( BEB ) is characterized by progressive involuntary contractions of the protractor muscles , sometimes leading to a debilitating closure of the lids .
-BACKGROUND	It is currently treated with the injection of botulinum neurotoxin A ( BoNT/A ) .
-BACKGROUND	The purpose of this study was to compare 2 BoNT/A preparations ( i.e. , Xeomin and Botox ) in the treatment of BEB .
-METHODS	This was a prospective , randomized , double-blinded split-face technique in 48 patients already treated by Botox for BEB .
-METHODS	Patients received the same medication to either side of the face for 4 injections , and were then evaluated using subjective and objective measures .
-METHODS	Blepharospasm Disability Index ( BSDI ) and Jankovic Rating Scale ( JRS ) were assessed using a repeated-measures analysis of variance ( ANOVA ) and paired t test .
-METHODS	Patient preference and objective comparison of residual orbicularis strength and spasm were compared using a multinomial logistic regression model , a repeated-measures ANOVA , and a paired t test .
-RESULTS	A paired t test showed no preference between Xeomin and Botox ( P = 0.7205 ) and demonstrated a tendency toward not having a preference for either medication ( P = 0.0301 vs Botox and P = 0.0039 vs Xeomin ) .
-RESULTS	The regression model showed no effect of time on patient preference ( P = 0.4217 ) .
-RESULTS	The ANOVA for BSDI scores did not reveal any difference between the 2 medications as compared with baseline ( P = 0.8161 ) , nor did it demonstrate an effect of time on BSDI scores ( P = 0.6108 ) .
-RESULTS	A paired t test found no difference between the 2 scores ( P = 0.1909 ) at baseline .
-RESULTS	There was no difference in JRS scores for either medication when compared with baseline ( P = 0.2314 ) , nor was there an effect of time on such scores ( P = 0.4951 ) .
-RESULTS	There was also no difference between the 2 medications according to paired t test ( P = 0.3224 ) at baseline .
-RESULTS	Baseline residual orbicularis strength was similar between the 2 medications ( paired t test ; P = 0.3228 ) .
-RESULTS	ANOVA shows an effect of time on orbicularis strength ( P = 0.0055 ) , but no difference was seen at any of the 5 visits ( P > 0.05 ) .
-RESULTS	Baseline spasm scores were similar between Botox and Xeomin ( paired Student t test ; P = 0.3228 ) .
-RESULTS	The ANOVA shows no difference between both medications at any point in time ( P = 0.4408 ) , and that time had no effect on the efficacy of either treatment ( P = 0.3268 ) .
-CONCLUSIONS	No difference between Xeomin and Botox was detected in either subjective or objective measures for the treatment of BEB .
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-###24655769
-BACKGROUND	Co-morbid depression in HIV-positive patients on anti-retroviral ( ART ) treatment poses a public health threat .
-BACKGROUND	It compromises treatment adherence and accelerates disease progression .
-BACKGROUND	This study aimed to assess the feasibility of a group-based counselling intervention for depressed HIV-positive patients in primary health care ( PHC ) in South Africa using a task shifting approach .
-METHODS	Using a randomized control design , 76 HIV-positive patients with co-morbid depression were initially recruited .
-METHODS	This reduced to 34 in the final cohort .
-METHODS	Participants were assessed using the Patient Health Questionnaire ( PHQ9 ) , Hopkins Symptom Checklist ( HSCL-25 ) and Multidimensional Scale of Perceived Social Support ( MSPSS ) at baseline and 3-month follow-up .
-METHODS	The intervention was adapted from a local group-based Interpersonal Therapy ( IPT ) intervention .
-METHODS	Process evaluation interviews were held with the HIV counsellors who delivered the intervention and a sub-sample of participants .
-RESULTS	Repeated measures ANOVA analysis showed significantly greater improvement on depression scores on the PHQ9 in the intervention group compared to the control group .
-RESULTS	A significant decline in the mean scores on the HSCL-25 was found for both groups although this was more pronounced for the intervention group .
-RESULTS	There was no significant improvement in the MSPSS scores .
-CONCLUSIONS	The small sample size of the final cohort affected the power of the study to detect significant differences between the intervention and control groups on the MSPSS .
-CONCLUSIONS	Longer term impact of the intervention is unknown .
-CONCLUSIONS	These preliminary findings suggest that group-based counselling for depression in HIV-positive patients can potentially be effectively delivered by appropriately trained and supported lay HIV counsellors .
-CONCLUSIONS	The need for a larger trial is indicated .
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-###24370240
-OBJECTIVE	To evaluate antinociceptive effects and pharmacokinetics of butorphanol tartrate after IM administration to American kestrels ( Falco sparverius ) .
-METHODS	Fifteen 2 - to 3-year-old American kestrels ( 6 males and 9 females ) .
-METHODS	Butorphanol ( 1 , 3 , and 6 mg/kg ) and saline ( 0.9 % NaCl ) solution were administered IM to birds in a crossover experimental design .
-METHODS	Agitation-sedation scores and foot withdrawal response to a thermal stimulus were determined 30 to 60 minutes before ( baseline ) and 0.5 , 1.5 , 3 , and 6 hours after treatment .
-METHODS	For the pharmacokinetic analysis , butorphanol ( 6 mg/kg , IM ) was administered in the pectoral muscles of each of 12 birds .
-RESULTS	In male kestrels , butorphanol did not significantly increase thermal thresholds for foot withdrawal , compared with results for saline solution administration .
-RESULTS	However , at 1.5 hours after administration of 6 mg of butorphanol/kg , the thermal threshold was significantly decreased , compared with the baseline value .
-RESULTS	Foot withdrawal threshold for female kestrels after butorphanol administration did not differ significantly from that after saline solution administration .
-RESULTS	However , compared with the baseline value , withdrawal threshold was significantly increased for 1 mg/kg at 0.5 and 6 hours , 3 mg/kg at 6 hours , and 6 mg/kg at 3 hours .
-RESULTS	There were no significant differences in mean sedation-agitation scores , except for males at 1.5 hours after administration of 6 mg/kg .
-CONCLUSIONS	Butorphanol did not cause thermal antinociception suggestive of analgesia in American kestrels .
-CONCLUSIONS	Sex-dependent responses were identified .
-CONCLUSIONS	Further studies are needed to evaluate the analgesic effects of butorphanol in raptors .
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-###25592197
-OBJECTIVE	To evaluate the efficacy and safety of dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin and sulfonylurea .
-METHODS	Patients with HbA1c of 7.0 % ( 53 mmol/mol ) to 10.5 % ( 91 mmol/mol ) receiving sulfonylurea and metformin were randomized to receive dapagliflozin 10 mg/day ( n = 109 ) or placebo ( n = 109 ) for 24 weeks .
-RESULTS	HbA1c ( baseline : dapagliflozin 8.08 % [ 65 mmol/mol ] ; placebo 8.24 % [ 67 mmol/mol ] ) and fasting plasma glucose ( baseline : dapagliflozin 167.4 mg/dL [ 9.29 mmol/L ] ; placebo 180.5 mg/dL [ 10.02 mmol/L ] ) significantly improved from baseline with dapagliflozin ( placebo-subtracted change -0.69 % [ -7.5 mmol/mol ] , P < 0.0001 ; -33.5 mg/dL [ -1.86 mmol/L ] , P < 0.0001 , respectively ) .
-RESULTS	More patients achieved a therapeutic glycemic response ( HbA1c < 7.0 % [ 53 mmol/mol ] ) with dapagliflozin ( 31.8 % ) versus placebo ( 11.1 % ) ( P < 0.0001 ) .
-RESULTS	Body weight and systolic blood pressure were significantly reduced from baseline over 24 and 8 weeks , respectively , with dapagliflozin ( placebo-subtracted change -2.1 kg , P < 0.0001 ; -3.8 mmHg , P = 0.0250 ) .
-RESULTS	Patients receiving dapagliflozin showed placebo-subtracted increases in total , LDL , and HDL cholesterol ( 11.4 mg/dL , P = 0.0091 ; 11.4 mg/dL , P = 0.0030 ; 2.2 mg/dL , P = 0.0172 , respectively ) with no change in LDL/HDL cholesterol ratio ( 0.1 ; P = 0.2008 ) or triglycerides ( -16.5 mg/dL ; P = 0.1755 ) .
-RESULTS	Adverse events occurred in 48.6 % of patients receiving dapagliflozin and 51.4 % receiving placebo .
-RESULTS	Significantly more patients with dapagliflozin compared with placebo experienced hypoglycemia ( 12.8 vs. 3.7 % ; P = 0.024 ) and genital infections ( 5.5 vs. 0 % ; P = 0.029 ) .
-RESULTS	Events of urinary tract infection were reported by 6.4 % of patients in both groups .
-CONCLUSIONS	Dapagliflozin was well tolerated and effective over 24 weeks as add-on to metformin plus sulfonylurea .
-CONCLUSIONS	Adverse effects included hypoglycemia and genital infections .
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-###25035200
-BACKGROUND	Patients treated with radiation therapy for laryngeal cancer often experience voice problems .
-BACKGROUND	The aim of this randomized controlled trial was to assess the efficacy of voice rehabilitation for laryngeal cancer patients after having undergone radiation therapy and to investigate whether differences between different tumor localizations with regard to rehabilitation outcomes exist .
-METHODS	Sixty-nine male patients irradiated for laryngeal cancer participated .
-METHODS	Voice recordings and self-assessments of communicative dysfunction were performed 1 and 6 months after radiation therapy .
-METHODS	Thirty-three patients were randomized to structured voice rehabilitation with a speech-language pathologist and 36 to a control group .
-METHODS	Furthermore , comparisons with 23 healthy control individuals were made .
-METHODS	Acoustic analyses were performed for all patients , including the healthy control individuals .
-METHODS	The Swedish version of the Self Evaluation of Communication Experiences after Laryngeal Cancer and self-ratings of voice function were used to assess vocal and communicative function .
-RESULTS	The patients who received vocal rehabilitation experienced improved self-rated vocal function after rehabilitation .
-RESULTS	Patients with supraglottic tumors who received voice rehabilitation had statistically significant improvements in voice quality and self-rated vocal function , whereas the control group did not .
-CONCLUSIONS	Voice rehabilitation for male patients with laryngeal cancer is efficacious regarding patient-reported outcome measurements .
-CONCLUSIONS	The patients experienced better voice function after rehabilitation .
-CONCLUSIONS	Patients with supraglottic tumors also showed an improvement in terms of acoustic voice outcomes .
-CONCLUSIONS	Rehabilitation with a speech-language pathologist is recommended for laryngeal cancer patients after radiation therapy , particularly for patients with supraglottic tumors .
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-###25348594
-BACKGROUND	Antireflux therapy may lead to recovery of impaired mucosal integrity in gastro-esophageal reflux disease ( GERD ) patients as reflected by an increase in baseline impedance .
-BACKGROUND	The study objective was to evaluate the effect of endoscopic fundoplication and proton pump inhibitor ( PPI ) PPI therapy on baseline impedance and heartburn severity in GERD patients .
-METHODS	Forty-seven GERD patients randomized to endoscopic fundoplication ( n = 32 ) or PPI therapy ( n = 15 ) , and 29 healthy controls were included .
-METHODS	Before randomization and 6months after treatment , baseline impedance was obtained during 24-h pH-impedance monitoring .
-METHODS	Heartburn severity was evaluated using the GERD-HRQL questionnaire .
-RESULTS	Before treatment , baseline impedance in GERD patients was lower than in healthy controls ( p < 0.001 ) .
-RESULTS	Antireflux therapy increased baseline impedance ( from 1498 [ IQR 951-2472 ] to 2393 [ IQR 1353-3027 ] , p = 0.001 ) , however it only led to a partial recovery when compared to healthy controls ( 2393 [ IQR 1353-3027 ] vs 2983 [ 2335-3810 ] , p < 0.01 ) .
-RESULTS	The effect of both treatment options was not significantly different ( p = 0.13 ) despite the increased number of non-acid reflux events in the PPI group .
-RESULTS	No correlation was found between baseline impedance and GERD symptoms before or after treatment .
-CONCLUSIONS	Reduction in acid reflux by endoscopic fundoplication or PPI therapy leads to an increase in baseline impedance in GERD patients , likely to reflect recovery of mucosal integrity .
-CONCLUSIONS	The impact of non-acid reflux events on esophageal mucosal integrity may be limited as no difference in the increase in baseline impedance was observed after both treatment options .
-CONCLUSIONS	The lack of association between impedance baseline and heartburn severity indicates that other factors may contribute to heartburn perception in GERD .
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-###24436354
-OBJECTIVE	Nitrate supplementation improves endurance exercise and single bouts of high-intensity activity , but its effect on repeated sprints is unclear .
-OBJECTIVE	This study is the first to investigate the effects of acute dietary nitrate supplementation during a high-intensity intermittent-sprint test to exhaustion .
-METHODS	Team-sport athletes ( 9 male , age 22.3 2.1 y , VO2max 57.4 8.5 mL kg-1 min-1 ; 7 female , age 20.7 1.3 y , VO2max 47.2 8.5 mL kg-1 min-1 ) were assigned to a double-blind , randomized , crossover design .
-METHODS	Participants consumed 70 mL of concentrated beetroot juice containing a minimum of 0.3 g of nitrate ( NT ) or 70 mL of placebo ( PL ) 2 h before a repeated-sprint protocol involving repeated 8-s sprints with 30-s recovery on a cycle ergometer to exhaustion .
-RESULTS	Fewer sprints ( NT = 13 5 vs PL = 15 6 , P = .005 , d = 0.41 ) and less total work ( NT = 49.2 24.2 kJ vs PL = 57.8 34.0 kJ , P = .027 , d = 0.3 ) were completed in NT relative to PL .
-RESULTS	However there was no difference in overall mean power output or the mean power output for each individual 8-s sprint .
-CONCLUSIONS	These findings suggest that dietary nitrate is not beneficial for improving repeated-sprint performance , at least when such sprints are near-maximal and frequent in nature .
-CONCLUSIONS	The lack of an effect of nitrate at near-maximal oxygen uptake supports the suggestion that at greater exercise intensities nitrate does not have an ergogenic effect .
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-###24631042
-BACKGROUND	Abelmoschus manihot , a single medicament of traditional Chinese medicine , has been widely used to treat kidney disease .
-BACKGROUND	This is the first randomized controlled clinical trial to assess its efficacy and safety in patients with primary glomerular disease .
-METHODS	Prospective , open-label , multicenter , randomized , controlled , clinical trial .
-METHODS	From May 2010 to October 2011 , a total of 417 patients with biopsy-proven primary glomerular disease from 26 hospitals participated in the study .
-METHODS	A manihot in the form of a huangkui capsule , 2.5 g , 3 times per day ; losartan potassium , 50mg/d ; or combined treatment , a huangkui capsule at 2.5 g 3 times per day , was combined with losartan potassium , 50mg/d .
-METHODS	The duration of intervention was 24 weeks .
-METHODS	The primary outcome was change in 24-hour proteinuria from baseline after treatment .
-METHODS	Change in estimated glomerular filtration rate ( eGFR ) from baseline after treatment was a secondary outcome .
-METHODS	The 24-hour proteinuria was measured every 4 weeks and eGFR was measured at 0 , 4 , 12 , and 24 weeks .
-RESULTS	Mean baseline urine protein excretion was 1,045 , 1,084 , and 1,073 mg/d in the A manihot , losartan , and combined groups , respectively , and mean eGFR was 108 , 106 , and 106 mL/min/1 .73 m2 , respectively .
-RESULTS	After 24 weeks of treatment , mean changes in proteinuria were protein excretion of -508 , -376 , and -545 mg/d , respectively ( P = 0.003 for A manihot vs losartan and P < 0.001 for the combined treatment vs losartan ) .
-RESULTS	Mean eGFR did not change significantly .
-RESULTS	The incidence of adverse reactions was not different among the 3 groups ( P > 0.05 ) , and there were no severe adverse events in any group .
-CONCLUSIONS	Results can not be generalized to those with nephrotic syndrome or reduced eGFR .
-CONCLUSIONS	A manihot is a promising therapy for patients with primary kidney disease ( chronic kidney disease stages 1-2 ) with moderate proteinuria .
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-###25948717
-OBJECTIVE	To prospectively evaluate the neuropsychological effect of levetiracetam ( LVT ) in comparison with carbamazepine ( CBZ ) and its efficacy and tolerability as a monotherapy in children with focal epilepsy .
-METHODS	A total of 121 out of 135 screened children ( 4-16 years ) were randomly assigned to LVT or CBZ groups in a multicenter , parallel-group , open-label trial .
-METHODS	The study 's primary endpoints were defined as the end of 52 weeks of treatment , followed by analysis of changes observed in a series of follow-up neurocognitive , behavioral , and emotional function tests performed during treatment in the per protocol population .
-METHODS	Drug efficacy and tolerability were also analyzed among the intention-to-treat ( ITT ) population ( ClinicalTrials.gov , number NCT02208492 ) .
-RESULTS	Eighty-one patients ( 41 LVT , 40 CBZ ) from the randomly assigned ITT population of 121 children ( 57 LVT , 64 CBZ ) were followed up to their last visit .
-RESULTS	No significant worsening or differences were noted between groups in neuropsychological tests , except for the Children 's Depression Inventory ( LVT -1.97 vs CBZ +1.43 , p = 0.027 , [ + ] improvement of function ) .
-RESULTS	LVT-treated patients showed an improvement ( p = 0.004 ) in internalizing behavioral problems on the Korean Child Behavior Checklist .
-RESULTS	Seizure-free outcomes were not different between the 2 groups ( CBZ 57.8 % vs LVT 66.7 % , p = 0.317 ) .
-CONCLUSIONS	Neither LVT nor CBZ adversely affected neuropsychological function in pediatric patients .
-CONCLUSIONS	Both medications were considered equally safe and effective as monotherapy in children with focal epilepsy .
-METHODS	This study provides Class II evidence that in patients with pediatric focal epilepsy , LVT and CBZ exhibit equivalent effects on neuropsychological function .
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-###25840297
-OBJECTIVE	To compare the efficacy of 2 prophylaxis regimens before cataract surgery using topical antibiotics ( 1 hour before surgery versus the day before ) , both with povidone-iodine , with regard to reducing the preoperative conjunctival bacterial load .
-METHODS	Tertiary ophthalmic referral center , Munich , Germany .
-METHODS	Prospective comparative case series .
-METHODS	Eyes were treated with topical antibiotics and their conjunctival sac flush irrigated using 10 mL of povidone-iodine 1.0 % .
-METHODS	All eyes were randomized to receive either 4 applications of topical 3500 IU/mL neomycin sulfate/6000 IU/mL polymyxin-B sulfate within 1 hour preoperatively ( Group 1 ) or on the day before surgery ( Group 2 ) .
-METHODS	Conjunctival specimens were obtained at 4 timepoints : T0C untreated fellow eye ( control ) , T0 surgery eye ( after antibiotic prophylaxis but before povidone-iodine irrigation ) , T1 after povidone-iodine , and T2 at the conclusion of surgery .
-METHODS	All specimens were inoculated onto blood and chocolate-blood agar and into thioglycollate broth .
-RESULTS	One hundred thirty-three eyes of 133 consecutive patients were included ( Group 1 , 64 eyes ; Group 2 , 69 eyes ) .
-RESULTS	The antibiotic regimens were equally effective in reducing the aerobic and microaerophilic conjunctival flora ( Group 1 , P = .028 ; Group 2 , P = .000 ) , but had no significant effect on anaerobic bacteria ( Group 1 , P = .201 ; Group 2 , P = .117 ) .
-RESULTS	Flush irrigation of the conjunctival sac using 10.0 mL povidone-iodine 1.0 % significantly decreased the conjunctival bacterial load in both groups .
-CONCLUSIONS	Topical neomycin/polymyxin-B was equally effective in reducing the conjunctival bacterial load whether given 1 day or 1 hour before surgery .
-CONCLUSIONS	The greatest effect was achieved by irrigating the conjunctival sac using povidone-iodine .
-BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .
-
-###24568002
-BACKGROUND	Assessment is a critical component of therapeutic intervention as it serves as the basis from which clinical goals and objectives are derived .
-BACKGROUND	Unfortunately , there is a dearth of reliable group therapy assessment instruments , especially for children and preadolescents who have severe emotional disturbances .
-OBJECTIVE	The purpose of this study was to test reliability of a newly developed group therapy assessment instrument for use with children who have serious emotional disturbances that require placement in a residential or partial hospitalization treatment program .
-METHODS	After conducting an extensive literature review , the authors developed , refined , and tested a group therapy assessment tool for use in both music therapy and traditional therapy , measuring nine items : attention to task ( physical and verbal ) , eye contact , pro-social skills ( physical and verbal ) , empathy ( physical and verbal ) , and managing negative affect ( physical and verbal ) .
-METHODS	Six participants with a mean age of 9.5 ( SD = 1.85 ) years were randomly selected to test the group therapy assessment tool from a pool of 60 eligible children receiving group partial hospitalization therapy .
-METHODS	Participants were scored by three raters across two partial hospitalization therapy groups for inter-rater reliability .
-METHODS	Content and construct validity were also examined .
-RESULTS	Intraclass Coefficients ( ICC ) averaged 0.994 across all nine items indicating excellent inter-rater reliability .
-RESULTS	Content and construct validity was established and the instrument demonstrated good external validity potential .
-CONCLUSIONS	The Beech Brook Therapy Assessment Instrument has demonstrated excellent inter-rater reliability in measuring important behaviors of functioning central in the treatment of youth with severe and emotional disturbances .
-CONCLUSIONS	The measure has potential for wide utility and application in practice and research ; however , future studies are needed to establish external validity .
-
-###24839047
-BACKGROUND	Breakthrough cancer pain typically has a rapid onset and relatively short duration .
-BACKGROUND	Due to this temporal profile , it may not be adequately relieved by oral opioid analgesics .
-BACKGROUND	The sublingual fentanyl orally disintegrating tablet is a formulation by which fentanyl can be rapidly absorbed across the oral mucosa producing rapid-onset analgesia , and which may be effective for breakthrough pain treatment .
-METHODS	A multicenter , randomized , placebo-controlled , double-blind comparative study was conducted to evaluate the efficacy and safety of the sublingual fentanyl tablet at optimized doses for breakthrough pain treatment in cancer patients treated with strong opioid analgesics at fixed intervals .
-METHODS	The optimal dose was determined by open-label dose titration .
-METHODS	The efficacy and safety of a 12-week extended treatment were also evaluated .
-RESULTS	Eleven of 42 subjects who received the sublingual fentanyl tablet experienced adverse drug reactions .
-RESULTS	Common reactions were somnolence , constipation , nausea , and vomiting .
-RESULTS	No serious adverse reactions occurred .
-RESULTS	Sublingual fentanyl tablets at optimal doses and placebo were administered to 37 subjects in a double-blinded manner .
-RESULTS	A significant analgesic effect of the sublingual fentanyl tablet was present compared to placebo at 30 min after administration .
-RESULTS	The sublingual fentanyl tablet was also effective and safe during extended treatment , in which changes in basal opioid doses as well as sublingual fentanyl tablet doses were made as needed .
-CONCLUSIONS	Sublingual fentanyl tablets at doses determined by titration were effective and safe for breakthrough pain treatment in cancer patients treated with strong opioid analgesics at fixed intervals .
-CONCLUSIONS	Extended treatment up to 12 weeks was also effective and safe .
-
-###25675060
-BACKGROUND	Extensive decompression with laminectomy , where appropriate , is often still described as the method of choice when operating on degenerative lumbar spinal stenosis .
-BACKGROUND	Nonetheless , tissue-sparing procedures are becoming more common .
-BACKGROUND	Endoscopic techniques have become the standard in many areas because of the surgical advantages they offer and the benefits for rehabilitation .
-BACKGROUND	One key issue when operating on the spine was the development of instruments to provide sufficient bone resection under continuous visual control .
-BACKGROUND	This was achieved by using endoscopes for operations carried out in cases of spinal canal stenosis .
-OBJECTIVE	This study of patients with degenerative lumbar central spinal stenosis compares the results of spinal decompression using the full-endoscopic interlaminar technique ( FI ) with a conventional microsurgical laminotomy technique ( MI ) .
-METHODS	Prospective , randomized , controlled study .
-METHODS	135 patients with microsurgical or full-endoscopic decompression were followed up for 2 years .
-METHODS	Alongside general and specific parameters , the following measuring instruments were also used for the investigation : Visual Analog Scale ( VAS ) , German version of the North American Spine Society Instrument ( NASS ) , Oswestry Low-Back-Pain-Disability Questionnaire ( ODI ) .
-RESULTS	Postoperatively 72 % of the patients no longer had leg pain or the pain was almost completely reduced and 21.2 % experienced occasional pain .
-RESULTS	The clinical results were the same in both groups .
-RESULTS	The rate of complications and revisions was significantly reduced in the FI Group .
-RESULTS	The full-endoscopic techniques brought advantages in the following areas : operation , complications , traumatization , rehabilitation .
-CONCLUSIONS	Lack of placebo control group .
-CONCLUSIONS	The recorded results demonstrate that the full-endoscopic interlaminar bilateral decompression adopting a unilateral approach provides an adequate and safe supplement and alternative to the conventional microsurgical bilateral laminotomy technique when the indication criteria are fulfilled .
-CONCLUSIONS	At the same time , it offers the advantages of a minimally invasive intervention .
-
-###24410959
-BACKGROUND	The doctor-patient encounter ( DPE ) and associated patient expectations are potential confounders in open-label randomized trials of treatment efficacy .
-BACKGROUND	It is therefore important to evaluate the effects of the DPE on study outcomes .
-METHODS	Four hundred participants with chronic low back pain ( LBP ) were randomized to four dose groups : 0 , 6 , 12 , or 18 sessions of spinal manipulation from a chiropractor .
-METHODS	Participants were treated three times per week for six weeks .
-METHODS	They received light massage control at visits when manipulation was not scheduled .
-METHODS	Treating chiropractors were instructed to have equal enthusiasm for both interventions .
-METHODS	A path analysis was conducted to determine the effects of dose , patient expectations of treatment success , and DPE on LBP intensity ( 100-point scale ) at the end of care ( 6 weeks ) and primary endpoint ( 12 weeks ) .
-METHODS	Direct , indirect , and total standardized effects ( total ) were computed .
-METHODS	Expectations and DPE were evaluated on Likert scales .
-METHODS	The DPE was assessed as patient-rated perception of chiropractor enthusiasm , confidence , comfort with care , and time spent .
-RESULTS	The DPE was successfully balanced across groups , as were baseline expectations .
-RESULTS	The principal finding was that the magnitude of the effects of DPE on LBP at 6 and 12 weeks ( | | total = 0.22 and 0.15 , p < .05 ) were comparable to the effects of dose of manipulation at those times ( | | total = 0.11 and 0.12 , p < .05 ) .
-RESULTS	In addition , baseline expectations had no notable effect on follow-up LBP .
-RESULTS	Subsequent expectations were affected by LBP , DPE , and dose ( p < .05 ) .
-CONCLUSIONS	The DPE can have a relatively important effect on outcomes in open-label randomized trials of treatment efficacy .
-CONCLUSIONS	Therefore , attempts should be made to balance the DPE across treatment groups and report degree of success in study publications .
-CONCLUSIONS	We balanced the DPE across groups with minimal training of treatment providers .
-BACKGROUND	ClinicalTrials.gov NCT00376350 .
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-###25474533
-OBJECTIVE	To identify risk factors for failure of anticoagulant thromboprophylaxis in critically ill patients in the ICU .
-METHODS	Multivariable regression analysis of thrombosis predictors from a randomized thromboprophylaxis trial .
-METHODS	Sixty-seven medical-surgical ICUs in six countries .
-METHODS	Three thousand seven hundred forty-six medical-surgical critically ill patients .
-METHODS	All patients received anticoagulant thromboprophylaxis with low-molecular-weight heparin or unfractionated heparin at standard doses .
-RESULTS	Independent predictors for venous thromboembolism , proximal leg deep vein thrombosis , and pulmonary embolism developing during critical illness were assessed .
-RESULTS	A total of 289 patients ( 7.7 % ) developed venous thromboembolism .
-RESULTS	Predictors of thromboprophylaxis failure as measured by development of venous thromboembolism included a personal or family history of venous thromboembolism ( hazard ratio , 1.64 ; 95 % CI , 1.03-2 .59 ; p = 0.04 ) and body mass index ( hazard ratio , 1.18 per 10-point increase ; 95 % CI , 1.04-1 .35 ; p = 0.01 ) .
-RESULTS	Increasing body mass index was also a predictor for developing proximal leg deep vein thrombosis ( hazard ratio , 1.25 ; 95 % CI , 1.06-1 .46 ; p = 0.007 ) , which occurred in 182 patients ( 4.9 % ) .
-RESULTS	Pulmonary embolism occurred in 47 patients ( 1.3 % ) and was associated with body mass index ( hazard ratio , 1.37 ; 95 % CI , 1.02-1 .83 ; p = 0.035 ) and vasopressor use ( hazard ratio , 1.84 ; 95 % CI , 1.01-3 .35 ; p = 0.046 ) .
-RESULTS	Low-molecular-weight heparin ( in comparison to unfractionated heparin ) thromboprophylaxis lowered pulmonary embolism risk ( hazard ratio , 0.51 ; 95 % CI , 0.27-0 .95 ; p = 0.034 ) while statin use in the preceding week lowered the risk of proximal leg deep vein thrombosis ( hazard ratio , 0.46 ; 95 % CI , 0.27-0 .77 ; p = 0.004 ) .
-CONCLUSIONS	Failure of standard thromboprophylaxis using low-molecular-weight heparin or unfractionated heparin is more likely in ICU patients with elevated body mass index , those with a personal or family history of venous thromboembolism , and those receiving vasopressors .
-CONCLUSIONS	Alternate management or incremental risk reduction strategies may be needed in such patients .
-
-###25332150
-BACKGROUND	We conducted this pilot randomized clinical trial to determine the feasibility of a large clinical trial aimed at testing whether early use of catheter ablation of ventricular tachycardia ( VT ) is superior to antiarrhythmic medications at reducing mortality .
-RESULTS	Patients were enrolled at 4 sites if they had ischemic heart disease , an implantable cardioverter defibrillator ( ICD ) , and received 1 ICD shock or 3 antitachycardia pacing therapies for VT. .
-RESULTS	Patients were randomized to 2 arms : ( 1 ) antiarrhythmic medication ( n = 14 ) and ( 2 ) catheter ablation ( n = 13 ) ; patients were followed at 3 and 6 months .
-RESULTS	Endpoints included recurrent VT , time to first ICD therapy for VT , and death .
-RESULTS	Of 243 screened patients , 27 were enrolled .
-RESULTS	Main reasons for screen failures were : ( 1 ) patient was already on an antiarrhythmic medication ( 88 [ 41 % ] ) , ( 2 ) VT due to a reversible cause ( 23 [ 11 % ] ) , and ( 3 ) incessant VT ( 20 [ 9 % ] ) .
-RESULTS	Fourteen patients had recurrent VT , 8 ( 62 % ) in the ablation arm and 6 ( 43 % ) in the antiarrhythmic medication arm .
-RESULTS	Median time to recurrent VT was 75 days ( 25th , 75th : 51 , 89 ) in the ablation arm and 57 days ( 30 , 145 ) in the antiarrhythmic arm .
-RESULTS	Four patients died , 2 in each arm .
-CONCLUSIONS	This clinical trial shows that most patients in clinical practice have already failed antiarrhythmic drug therapy before catheter ablation is considered , and the VT recurrence rates and death in these patients are high .
-CONCLUSIONS	For a large clinical trial to be feasible , factors limiting early consideration of catheter ablation need to be identified and addressed .
-
-###24387048
-BACKGROUND	Anxiety , Depression and Somatoform ( ADSom ) disorders are highly prevalent in primary care .
-BACKGROUND	Managing these disorders is time-consuming and requires strong commitment on behalf of the General Practitioners ( GPs ) .
-BACKGROUND	Furthermore , the management of these patients is restricted by the high patient turnover rates in primary care practices , especially in the German health care system.In order to address this problem , we implement a complex , low-threshold intervention by an Advanced Practice Nurse ( APN ) using a mixture of case management and counseling techniques to promote self-management in these patients .
-BACKGROUND	Here we present the protocol of the `` Self-Management Support for Anxiety , Depression and Somatoform Disorders in Primary Care '' ( SMADS ) - Study .
-METHODS	The study is designed as a cluster-randomized controlled trial , comparing an intervention and a control group of 10 primary care practices in each case .
-METHODS	We will compare the effectiveness of the intervention applied by an APN with usual GP-care .
-METHODS	A total of 340 participants will be enrolled in the study , 170 in either arm .
-METHODS	We use the Patient Health Questionnaire-German version ( PHQ-D ) as a screening tool for psychiatric symptoms , including patients with a score above 5 on any of the three symptom scales .
-METHODS	The primary outcome is self-efficacy , measured by the General Self-Efficacy Scale ( GSE ) , here used as a proxy for self-management .
-METHODS	As secondary outcomes we include the PHQ-D symptom load and questionnaires regarding coping with illness and health related quality of life .
-METHODS	Outcome assessments will be applied 8 weeks and 12 months after the baseline assessment .
-CONCLUSIONS	The SMADS-study evaluates a complex , low threshold intervention for ambulatory patients presenting ADSom-symptoms , empowering them to better manage their condition , as well as improving their motivation to engage in self-help and health-seeking behaviour .
-CONCLUSIONS	The benefit of the intervention will be substantiated , when patients can enhance their expected self-efficacy , reduce their symptom load and engage in more self-help activities to deal with their everyday lives .
-CONCLUSIONS	After successfully evaluating this psychosocial intervention , a new health care model for the management of symptoms of anxiety , depression and somatoform disorders for ambulatory patients could emerge , supplementing the work of the GP .
-BACKGROUND	Clinicaltrials.gov Identifier : NCT01726387 .
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-###24554548
-BACKGROUND	To compare the safety and efficacy of dexmedetomidine/propofol ( DP ) - total i.v. anaesthesia ( TIVA ) vs remifentanil/propofol ( RP ) - TIVA , both with spontaneous breathing , during airway foreign body ( FB ) removal in children .
-METHODS	Seventy-seven children undergoing rigid bronchoscopy for FB removal were randomly allocated to receive either RP-TIVA and spontaneous ventilation ( Group RP , n = 38 ) or DP-TIVA and spontaneous ventilation ( Group DP , n = 39 ) .
-METHODS	Heart rate , arterial pressure , pulse oxygen saturation ( Sp ( O2 ) ) , respiratory rate , end-tidal CO2 ( E ' ( CO2 ) ) , and induction time were recorded .
-METHODS	Adverse events , the intervention for these events , and postoperative care duration were also assessed .
-RESULTS	The mean induction times were comparable between the two groups ( Group RP 12.2 min vs Group DP 13.1 min , P > 0.05 ) .
-RESULTS	At the end of the procedure , the mean ( E ' ( CO2 ) ) was higher in Group RP ( Group RP 6.8 kPa vs Group DP 5.8 kPa , P < 0.001 ) , and respiratory rate was lower in Group RP ( Group RP 20.4 vs Group DP 35.8 , P < 0.001 ) .
-RESULTS	Additionally , the perioperative haemodynamic profile was more stable in Group DP than that in Group RP .
-RESULTS	The incidence rate of breath-holding and intervention were comparable between the two groups .
-RESULTS	In the post-anaesthesia care unit ( PACU ) , no hypoxaemia was observed , and emergence time increased in Group DP ( Group DP 65.1 min vs Group RP 23.8 min , P < 0.0001 ) .
-RESULTS	The incidence of cough in PACU was higher in Group RP ( Group RP 55.3 % vs Group DP 10.3 % , P < 0.0001 ) .
-CONCLUSIONS	Compared with RP-TIVA , DP-TIVA provided more stable respiratory and haemodynamic profiles , but required a longer recovery time .
-CONCLUSIONS	Clinical trial registration China Clinical Research Information Service , ChiCTR-TRC-13003018 .
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-###24317794
-OBJECTIVE	PPARGC1A and PPARGCB encode transcriptional coactivators that regulate numerous metabolic processes .
-OBJECTIVE	We tested associations and treatment ( i.e. metformin or lifestyle modification ) interactions with metabolic traits in the Diabetes Prevention Program , a randomised controlled trial in persons at high risk of type 2 diabetes .
-METHODS	We used Tagger software to select 75 PPARGCA1 and 94 PPARGC1B tag single-nucleotide polymorphisms ( SNPs ) for analysis .
-METHODS	These SNPs were tested for associations with relevant cardiometabolic quantitative traits using generalised linear models .
-METHODS	Aggregate genetic effects were tested using the sequence kernel association test .
-RESULTS	In aggregate , PPARGC1A variation was strongly associated with baseline triacylglycerol concentrations ( p = 2.910 ( -30 ) ) , BMI ( p = 2.010 ( -5 ) ) and visceral adiposity ( p = 1.910 ( -4 ) ) , as well as with changes in triacylglycerol concentrations ( p = 1.710 ( -5 ) ) and BMI ( p = 9.910 ( -5 ) ) from baseline to 1 year .
-RESULTS	PPARGC1B variation was only associated with baseline subcutaneous adiposity ( p = 0.01 ) .
-RESULTS	In individual SNP analyses , Gly482Ser ( rs8192678 , PPARGC1A ) was associated with accumulation of subcutaneous adiposity and worsening insulin resistance at 1 year ( both p < 0.05 ) , while rs2970852 ( PPARGC1A ) modified the effects of metformin on triacylglycerol levels ( p ( interaction ) = 0.04 ) .
-CONCLUSIONS	These findings provide several novel and other confirmatory insights into the role of PPARGC1A variation with respect to diabetes-related metabolic traits .
-BACKGROUND	ClinicalTrials.gov NCT00004992 .
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-###24857397
-BACKGROUND	The possible relationship between the circulating concentrations of T4 and GH sensitivity has not been elucidated .
-OBJECTIVE	The aim of this study is to evaluate the effect of levothyroxine supplementation on GH sensitivity in prepubertal boys with idiopathic short stature ( ISS ) .
-METHODS	We selected 28 prepubertal boys with ISS ( mean age 8.20.5 years ) and free T4 ( Ft4 ) concentrations between the 3rd and the 25th percentiles ( Ft4 : 0.8-1 .5 ng/dl ) .
-METHODS	They were randomly divided into two groups : Group A received thyroid supplementation ( 1-3g / kg/day ) for 120days , and Group B received placebo for the same period .
-METHODS	To evaluate GH sensitivity , an IGF-I generation test ( GH : 33g/kg/day sc for 3days ) was performed in both groups : under basal conditions , and after 120days of levothyroxine supplementation ( or placebo ) .
-RESULTS	After thyroid supplementation , Group A had higher Ft4 concentrations compared with Group B ( 2.140.06 vs 1.480.06 ng/dl , p = 0.01 ) , their growth velocity was significantly higher ( 2.30.1 vs 1.50.2 cm/4months ) , and they exhibited a greater increase in IGF-I after GH administration ( Group A : 32.53.8 % vs Group B 17.32.6 % ) .
-CONCLUSIONS	Supplementation with levothyroxine for 120days promotes an increase in growth velocity , and a greater IGF-I response to short-term GH administration in prepubertal boys with ISS and low-normal thyroid hormone concentrations .
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-###25764376
-BACKGROUND	Although conventional laparoscopic colectomy is a validated technique , laparoscopic natural-orifice specimen extraction ( NOSE ) colectomy might improve outcome .
-BACKGROUND	This randomized clinical trial compared analgesia requirements , postoperative pain , anorectal function , inflammatory response and cosmesis in laparoscopic NOSE colectomy and conventional laparoscopic colectomy .
-METHODS	Patients were randomly assigned to undergo laparoscopic NOSE colectomy or conventional laparoscopic colectomy for left-sided colonic disease .
-METHODS	The primary endpoint was analgesia requirement .
-METHODS	Secondary endpoints were operative outcome , inflammatory response , anorectal function and cosmesis .
-RESULTS	Forty patients were enrolled in the study , 20 in each group ( 15 with diverticulitis and 5 with colorectal cancer in each group ) .
-RESULTS	A significant difference was observed in morphine analogue requirements ( 1 of 20 patients in the NOSE group versus 10 of 20 in the conventional group ; P = 0003 ) .
-RESULTS	Patient-controlled epidural analgesia was lower in the NOSE group ( mean 116ml versus 221ml in the conventional group ; P < 0001 ) , as was paracetamol use ( mean 110 versus 170g respectively ; P < 0001 ) .
-RESULTS	Postoperative pain scores were lower in the NOSE group : mean maximum visual analogue score of 35 versus 21 ( P < 0001 ) .
-RESULTS	One week after hospital discharge , pain scores remained higher in the conventional group : 15 of 20 patients in the conventional group reported pain , compared with one of 20 in the NOSE group ( P < 0001 ) .
-RESULTS	Inflammatory responses were greater in patients undergoing NOSE colectomy : higher peak C-reactive protein and interleukin 6 levels were observed on postoperative day 2 ( P < 0001 ) and day 1 ( P = 0002 ) respectively .
-RESULTS	Postoperative anorectal function , complications and hospital stay were similar in the two groups .
-CONCLUSIONS	Laparoscopic NOSE colectomy was associated with less pain and lower analgesia requirements than the conventional laparoscopic extraction .
-BACKGROUND	NCT01033838 ( http://www.clinicaltrials.gov ) .
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-###25378974
-OBJECTIVE	This study was designed to evaluate the dose-effect relationship of statins in patients with ischemic congestive heart failure ( CHF ) , since the role of statins in CHF remains unclear .
-METHODS	The South koreAn Pitavastatin Heart FaIluRE ( SAPHIRE ) study was designed to randomize patients with ischemic CHF into daily treatments of 10 mg pravastatin or 4 mg pitavastatin .
-RESULTS	The low density lipoprotein cholesterol level decreased by 30 % in the pitavastatin group compared with 12 % in the pravastatin ( p < 0.05 ) group .
-RESULTS	Left ventricular systolic dimensions decreased significantly by 9 % in the pitavastatin group and by 5 % in the pravastatin group .
-RESULTS	Left ventricular ejection fraction ( EF ) improved significantly from 37 % to 42 % in the pitavastatin group and from 35 % to 39 % in the pravastatin group .
-RESULTS	Although the extent of the EF change was greater in the pitavastatin group ( 16 % vs. 11 % ) than that in the pravastatin group , no significant difference was observed between the groups ( p = 0.386 ) .
-RESULTS	Exercise capacity , evaluated by the 6-min walking test , improved significantly in the pravastatin group ( p < 0.001 ) , but no change was observed in the pitavastatin group ( p = 0.371 ) .
-CONCLUSIONS	Very low dose/low potency pravastatin and high dose/high potency pitavastatin had a beneficial effect on cardiac reverse remodeling and improved systolic function in patients with ischemic CHF .
-CONCLUSIONS	However , only pravastatin significantly improved exercise capacity .
-CONCLUSIONS	These findings suggest that lowering cholesterol too much may not be beneficial for patients with CHF .
-
-###25172376
-BACKGROUND	Impetigo affects more than 110 million children worldwide at any one time .
-BACKGROUND	The major burden of disease is in developing and tropical settings where topical antibiotics are impractical and lead to rapid emergence of antimicrobial resistance .
-BACKGROUND	Few trials of systemic antibiotics are available to guide management of extensive impetigo .
-BACKGROUND	As such , we aimed to compare short-course oral co-trimoxazole with standard treatment with intramuscular benzathine benzylpenicillin in children with impetigo in a highly endemic setting .
-METHODS	In this randomised , controlled , non-inferiority trial , Indigenous Australian children aged 3 months to 13 years with purulent or crusted non-bullous impetigo were randomly assigned ( 1:1:1 ) to receive benzathine benzylpenicillin ( weight-banded injection ) , twice-daily co-trimoxazole for 3 days ( 4 mg/kg plus 20 mg/kg per dose ) , or once-daily co-trimoxazole for 5 days ( 8 mg/kg plus 40 mg/kg per dose ) .
-METHODS	At every visit , participants were randomised in blocks of six and 12 , stratified by disease severity .
-METHODS	Randomisation was done by research nurses and codes were in sealed , sequentially numbered , opaque envelopes .
-METHODS	Independent reviewers masked to treatment allocation compared digital images of sores from days 0 and 7 .
-METHODS	The primary outcome was treatment success at day 7 in a modified intention-to-treat analysis .
-METHODS	This trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN12609000858291 .
-RESULTS	Between Nov 26 , 2009 , and Nov 20 , 2012 , 508 patients were randomly assigned to receive benzathine benzylpenicillin ( n = 165 [ 156 analysed ] ) , twice-daily co-trimoxazole for 3 days ( n = 175 [ 173 analysed ] ) , or once-daily co-trimoxazole for 5 days ( n = 168 [ 161 analysed ] ) .
-RESULTS	Treatment was successful in 133 ( 85 % ) children who received benzathine benzylpenicillin and 283 ( 85 % ) who received pooled co-trimoxazole ( absolute difference 05 % ; 95 % CI -62 to 73 ) , showing non-inferiority of co-trimoxazole ( 10 % margin ) .
-RESULTS	Results for twice-daily co-trimoxazole for 3 days and once-daily co-trimoxazole for 5 days were similar .
-RESULTS	Adverse events occurred in 54 participants , 49 ( 90 % ) of whom received benzathine benzylpenicillin .
-CONCLUSIONS	Short-course co-trimoxazole is a non-inferior , alternative treatment to benzathine benzylpenicillin for impetigo ; it is palatable , pain-free , practical , and easily administered .
-BACKGROUND	Australian National Health and Medical Research Council .
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-###25078304
-BACKGROUND	An unmet need exists for interferon-free and ribavirin-free treatments for chronic hepatitis C virus ( HCV ) infection .
-BACKGROUND	In this study , we assessed all-oral therapy with daclatasvir ( NS5A replication complex inhibitor ) plus asunaprevir ( NS3 protease inhibitor ) in patients with genotype 1b infection , including those with high unmet needs or cirrhosis , or both .
-METHODS	We did this phase 3 , multicohort study ( HALLMARK-DUAL ) at 116 sites in 18 countries between May 11 , 2012 , and Oct 9 , 2013 .
-METHODS	Patients were adults with chronic HCV genotype 1b infection who were treatment-naive ; previous non-responders to peginterferon alfa plus ribavirin ; or medically ineligible for , previously intolerant of , or ineligible for and intolerant of peginterferon alfa plus ribavirin .
-METHODS	Treatment-naive patients were randomly assigned ( 2:1 ratio ) by an interactive voice-response system with a computer-generated random allocation sequence ( stratified by cirrhosis status ) to receive daclatasvir 60 mg once daily plus asunaprevir 100 mg twice daily or placebo for 12 weeks .
-METHODS	Patients and investigator sites were masked to treatment assignment and HCV RNA results to the end of week 12 .
-METHODS	The treatment-naive group assigned to daclatasvir plus asunaprevir continued open-label treatment to the end of week 24 ; participants assigned to placebo entered another daclatasvir plus asunaprevir study .
-METHODS	Non-responders and ineligible , intolerant , or ineligible and intolerant patients received open-label daclatasvir plus asunaprevir for 24 weeks .
-METHODS	The primary endpoint was sustained virological response at post-treatment week 12 .
-METHODS	Efficacy analyses were restricted to patients given daclatasvir plus asunaprevir .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT01581203 .
-RESULTS	This study included 307 treatment-naive patients ( 205 received daclatasvir plus asunaprevir and 102 received placebo ; all randomly assigned patients received the intended treatment ) , 205 non-responders , and 235 ineligible , intolerant , or ineligible and intolerant patients .
-RESULTS	Daclatasvir plus asunaprevir provided sustained virological response in 182 ( 90 % , 95 % CI 85-94 ) patients in the treatment-naive cohort , 168 ( 82 % , 77-87 ) in the non-responder cohort , and 192 ( 82 % , 77-87 ) in the ineligible , intolerant , or ineligible and intolerant cohort .
-RESULTS	Serious adverse events occurred in 12 ( 6 % ) patients in the treatment-naive group ; 11 ( 5 % ) non-responders , and 16 ( 7 % ) ineligible , intolerant , or ineligible and intolerant patients ; adverse events leading to discontinuation ( most commonly reversible increases in alanine or aspartate aminotransferase ) occurred in six ( 3 % ) , two ( 1 % ) , and two ( 1 % ) patients , respectively , with no deaths recorded .
-RESULTS	Grade 3 or 4 laboratory abnormalities were uncommon , with low incidences of aminotransferase increases during the first 12 weeks with daclatasvir plus asunaprevir and placebo in treatment-naive patients ( 2 % each ) .
-CONCLUSIONS	Daclatasvir plus asunaprevir provided high sustained virological response rates in treatment-naive , non-responder , and ineligible , intolerant , or ineligible and intolerant patients , and was well tolerated in patients with HCV genotype 1b infection .
-CONCLUSIONS	These results support the use of daclatasvir plus asunaprevir as an all-oral , interferon-free and ribavirin-free treatment option for patients with HCV genotype 1b infection , including those with cirrhosis .
-BACKGROUND	Bristol-Myers Squibb .
-
-###26070059
-OBJECTIVE	To determine the normal variation in central retinal thickness asymmetry in healthy Caucasian adults using the posterior pole asymmetry analysis ( PPAA ) of a SPECTRALIS spectral-domain optical coherence tomography ( SD-OCT ) device .
-METHODS	Healthy Caucasian individuals aged between 18 and 45 years with a visual acuity of minimum 20/20 and a spherical equivalent between -1.5 and +1.5 diopters were recruited .
-METHODS	Retinal thickness and retinal nerve fiber layer thickness ( RNFL ) were using measured SPECTRALIS SD-OCT .
-METHODS	Inter - and intraocular differences in central retinal thickness were calculated using the PPAA .
-METHODS	The association between age , sex , and interocular asymmetry was evaluated by a linear model with Gaussian correlation structure .
-RESULTS	A total of 105 individuals , 30 men and 75 women , were studied .
-RESULTS	The mean age SD was 28.8 7.87 years .
-RESULTS	The grand mean interocular retinal thickness asymmetry was 5.6 m ( 95 % confidence interval [ CI ] : 4.6-6 .5 ) and the grand mean intraocular retinal thickness asymmetry was 8.3 m ( 95 % CI : 6.8-9 .9 ) in the right eye and 8.4 m ( 95 % CI : 6.7-10 .0 ) in the left eye .
-RESULTS	The highest local asymmetries were found in the nasal corners of macula were the posterior pole thickness map overlaps the temporal vascular arches .
-RESULTS	A slight general age and sex effect on the mean interocular retinal thickness asymmetry was found to be respectively 0.04 m/year ( 95 % CI : 0.02-0 .06 m ) and 0.54 m ( 95 % CI : 0.19-0 .88 m ) for men compared with women .
-CONCLUSIONS	Statistically significant physiological asymmetries in inter - and intraocular central retinal thickness exist .
-CONCLUSIONS	This must be considered when early signs of glaucoma or other pathologies are evaluated based on the retinal thickness asymmetry .
-CONCLUSIONS	( http://www.controlled-trials.com/isrctn/ number , ISRCTN09017572 . )
-
-###25577713
-OBJECTIVE	We seek to test the efficacy of noninvasive sphenopalatine ganglion block for the treatment of acute anterior headache in the emergency department ( ED ) using a novel noninvasive delivery device .
-METHODS	We conducted a randomized , double-blind , placebo-controlled trial evaluating bupivacaine anesthesia of the sphenopalatine ganglion for acute anterior or global-based headache .
-METHODS	This study was completed in 2 large academic EDs .
-METHODS	Bupivacaine or normal saline solution was delivered intranasally ( 0.3 mL per side ) with the Tx360 device .
-METHODS	Pain and nausea were measured at 0 , 5 , and 15 minutes by a 100-mm visual analog scale .
-METHODS	The primary endpoint was a 50 % reduction in pain at 15 minutes .
-METHODS	Telephone follow-up assessed 24-hour pain and nausea through a 0 - to 10-point verbal scale and adverse effects .
-RESULTS	The median reported baseline pain in the bupivacaine group was 80 mm ( IQR 66 mm - 93 mm ) and 78.5 mm ( IQR 64 mm to 91.75 mm ) in the normal saline solution group .
-RESULTS	A 50 % reduction in pain was achieved in 48.8 % of the bupivacaine group ( 20/41 patients ) versus 41.3 % in the normal saline solution group ( 19/46 patients ) , for an absolute risk difference of 7.5 % ( 95 % confidence interval [ CI ] -13 % to 27.1 % ) .
-RESULTS	As a secondary outcome , at 24 hours , more patients in the bupivacaine group were headache free ( 24.7 % difference ; 95 % CI 2.6 % to 43.6 % ) and more were nausea free ( 16.9 % difference ; 95 % CI 0.8 % to 32.5 % ) .
-CONCLUSIONS	For patients with acute anterior headache , sphenopalatine ganglion block with the Tx360 device with bupivacaine did not result in a significant increase in the proportion of patients achieving a greater than or equal to 50 % reduction in headache severity at 15 minutes compared with saline solution applied in the same manner .
-
-###24464122
-BACKGROUND	Vibration anesthesia is an effective pain-reduction technique for facial cosmetic injections .
-BACKGROUND	The analgesic effect of this method was tested in this study during facial dermal filler injections .
-BACKGROUND	The study aimed to evaluate the safety and efficacy of vibration anesthesia for these facial injections .
-METHODS	This prospective study analyzed 41 patients who received dermal filler injections to the nasolabial folds , tear troughs , cheeks , and other facial sites .
-METHODS	The injections were administered in a randomly assigned split-face design .
-METHODS	One side of the patient 's face received vibration together with dermal filler injections , whereas the other side received dermal filler injections alone .
-METHODS	The patients completed a posttreatment questionnaire pertaining to injection pain , adverse effects , and preference for vibration with future dermal filler injections .
-RESULTS	The patients experienced both clinically and statistically significant pain reduction when a vibration stimulus was co-administered with the dermal filler injections .
-RESULTS	No adverse events were reported .
-RESULTS	The majority of the patients ( 95 % ) reported a preference for vibration anesthesia with subsequent dermal filler injections .
-CONCLUSIONS	Vibration is a safe and effective method of achieving anesthesia during facial dermal filler injections .
-METHODS	This journal requires that authors assign a level of evidence to each article .
-METHODS	For a full description of these Evidence-Based Medicine ratings , please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
-
-###24577847
-BACKGROUND	The Institute of Medicine recommends developing a broader workforce of mental health providers , including nontraditional providers , to expand services for older adults .
-BACKGROUND	Cognitive behavior therapy ( CBT ) is effective for late-life generalized anxiety disorder ( GAD ) , but no study has examined outcomes with delivery by lay providers working under the supervision of licensed providers .
-BACKGROUND	The current study examined the effects of CBT delivered by lay , bachelor-level providers ( BLP ) relative to Ph.D.-level expert providers ( PLP ) , and usual care ( UC ) in older adults with GAD .
-METHODS	Participants were 223 older adults ( mean age , 66.9 years ) with GAD recruited from primary care clinics at two sites and assigned randomly to BLP ( n = 76 ) , PLP ( n = 74 ) , or UC ( n = 73 ) .
-METHODS	Assessments occurred at baseline and 6 months .
-METHODS	CBT in BLP and PLP included core and elective modules ( 3 months : skills training ; 3 months : skills review ) delivered in person and by telephone , according to patient choice .
-RESULTS	CBT in both BLP and PLP groups significantly improved GAD severity ( GAD Severity Scale ) , anxiety ( Spielberger State-Trait Anxiety Inventory ; Structured Interview Guide for the Hamilton Anxiety Scale ) , depression ( Patient Health Questionnaire ) , insomnia ( Insomnia Severity Index ) , and mental health quality of life ( Short-Form-12 ) , relative to UC .
-RESULTS	Response rates defined by 20 % reduction from pre - to posttreatment in at least three of four primary outcomes were higher for study completers in BLP and PLP relative to UC ( BLP : 38.5 % ; PLP : 40.0 % ; UC : 19.1 % ) .
-CONCLUSIONS	Lay providers , working under the supervision of licensed providers , can deliver effective CBT .
-
-###24837690
-BACKGROUND	The benefit of statins in patients with acute aneurysmal subarachnoid haemorrhage is unclear .
-BACKGROUND	We aimed to determine whether simvastatin 40 mg could improve the long-term outcome in patients with this disorder .
-METHODS	In this international , multicentre , randomised , double-blind trial , we enrolled patients aged 18-65 years with confirmatory evidence of an aneurysmal subarachnoid haemorrhage and presenting less than 96 h from ictus from 35 acute neurosurgical centres in nine countries .
-METHODS	Patients were randomly allocated ( 1:1 ) to receive either simvastatin 40 mg or placebo once a day for up to 21 days .
-METHODS	We used a computer-generated randomisation code to randomise patients in every centre by blocks of ten ( five simvastatin , five placebo ) .
-METHODS	Participants and investigators were masked to treatment assignment .
-METHODS	The primary outcome was the distribution of modified Rankin Scale ( mRS ) score obtained by questionnaire at 6 months .
-METHODS	Analyses were done on the intention-to-treat population .
-METHODS	This trial has been completed and is registered with Current Controlled Trials , number ISRCTN75948817 .
-RESULTS	Between Jan 6 , 2007 , and Feb 1 , 2013 , apart from the period between May 15 , 2009 , and Feb 8 , 2011 , when recruitment was on hold , 803 patients were randomly assigned to receive either simvastatin 40 mg ( n = 391 ) or placebo ( n = 412 ) .
-RESULTS	All patients were included in the intention-to-treat population .
-RESULTS	782 ( 97 % ) patients had outcome data recorded at 6 months , of whom 560 ( 72 % ) were classed as having a favourable outcome , mRS 0-2 ( 271 patients in the simvastatin group vs 289 in the placebo group ) .
-RESULTS	The primary ordinal analysis of the mRS , adjusted for age and World Federation of Neurological Surgeons grade on admission , gave a common odds ratio ( OR ) of 097 , 95 % CI 075-125 ; p = 0803 .
-RESULTS	At 6 months , we recorded 37 ( 10 % ) deaths in the simvastatin group compared with 35 ( 9 % ) in the placebo group ( log-rank p = 0592 ) .
-RESULTS	70 ( 18 % ) serious adverse events were reported in the simvastatin group compared with 74 ( 18 % ) in the placebo group .
-RESULTS	No suspected unexpected serious adverse reactions were reported .
-CONCLUSIONS	The STASH trial did not detect any benefit in the use of simvastatin for long-term or short-term outcome in patients with aneurysmal subarachnoid haemorrhage .
-CONCLUSIONS	Despite demonstrating no safety concerns , we conclude that patients with subarachnoid haemorrhage should not be treated routinely with simvastatin during the acute stages .
-BACKGROUND	British Heart Foundation .
-
-###25187581
-BACKGROUND	Although epidural analgesia has been used for postoperative pain control after total knee arthroplasty , its usefulness is being reevaluated because of possible adverse effects .
-BACKGROUND	Recent studies have proven the efficacy of periarticular analgesic injection and its low prevalence of adverse effects .
-BACKGROUND	The present study compares the clinical efficacies of epidural analgesia and periarticular injection after total knee arthroplasty .
-METHODS	This is a prospective , single-center , randomized controlled trial involving patients scheduled for unilateral total knee arthroplasty .
-METHODS	One hundred and eleven patients were randomly assigned to periarticular injection or epidural analgesia groups .
-METHODS	All patients were managed with spinal anesthesia .
-METHODS	The surgical technique and postoperative medication protocol were identical in both groups .
-METHODS	The primary outcome was postoperative pain at rest , quantified as the area under the curve of the scores on a visual analog pain scale to seventy-two hours postoperatively .
-METHODS	The Student t test and chi-square test were used to compare the data between groups .
-RESULTS	In the intention-to-treat analysis , the periarticular injection group had a significantly lower area under the curve for pain score at rest ( 788.0 versus 1065.9 ; p = 0.0059 ) .
-RESULTS	In the periarticular injection group , the mean knee flexion angle was small but significantly better at postoperative day 1 ( 64.2 versus 54.6 ; p = 0.0072 ) and postoperative day 2 ( 70.3 versus 64.6 ; p = 0.021 ) than in the epidural analgesia group .
-RESULTS	The incidence of nausea at postoperative day 1 was significantly lower in the periarticular injection group ( 4.0 % versus 44.3 % ; p < 0.0001 ) .
-RESULTS	Transient peroneal nerve palsy was frequently seen in the periarticular injection group ( 12.0 % versus 1.6 % ; p = 0.026 ) .
-CONCLUSIONS	Compared with epidural analgesia , periarticular injection offers better postoperative pain relief , earlier recovery of knee flexion angle , and lower incidence of nausea .
-CONCLUSIONS	Care should be taken to avoid transient peroneal nerve palsy when using periarticular injection .
-METHODS	Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .
-
-###24938224
-BACKGROUND	In 2013 the World Health Organization deemed hypertension as a global crisis as it is the leading risk factor attributed to global mortality .
-BACKGROUND	Therefore , there is a great need for effective alternative treatment strategies to combat a condition that affects 40 % of adults worldwide .
-BACKGROUND	Recently , the FlaxPAD Trial observed a significant reduction in systolic and diastolic blood pressure in hypertensive patients with peripheral arterial disease that consumed 30 g of milled flaxseed per day for one year .
-BACKGROUND	However , these patients were already on anti-hypertensive medication .
-BACKGROUND	Therefore , there is a need to assess if dietary flaxseed can effectively reduce blood pressure in the absence of peripheral arterial disease and anti-hypertensive medication in newly diagnosed hypertensive patients .
-METHODS	The HYPERFlax Trial is a parallel , superiority , phase II/III , randomized , double-blinded , controlled clinical trial .
-METHODS	St. Boniface Hospital and the Health Sciences Centre of Winnipeg , Canada , will recruit 100 participants newly diagnosed with stage 1 hypertension who have yet to be administered anti-hypertensive medication .
-METHODS	Participants will be randomly allocated with a 1:1 ratio into a flaxseed or control group and provided food products to consume daily for six months .
-METHODS	At baseline , two , four , and six months , participant assessments will include the primary outcome measure , averaged automated blood pressure , and secondary measures : 24-hour food recall , international physical activity questionnaire , anthropometrics , and blood and urine sampling for biochemical analysis .
-METHODS	Plasma will be assessed for lipids , metabolomics profiling , and molecules that regulate vascular tone .
-METHODS	Urine will be collected for metabolomics profiling .
-METHODS	With an estimated dropout rate of 20 % , the trial will have a power of 0.80 to detect differences between groups and across time , out of an effect size of 0.7 ( SD ) at an level of 0.05 .
-CONCLUSIONS	This trial will determine if dietary flaxseed is efficacious over six months as an anti-hypertensive therapy in subjects newly diagnosed with hypertension .
-CONCLUSIONS	If flaxseed can effectively reduce blood pressure as a monotherapy , then flaxseed will provide individuals on a global basis with a cost-effective food-based strategy to control hypertension .
-BACKGROUND	NCT01952340 , Registered 24 September 2013 .
-
-###25052018
-BACKGROUND	The indocyanine green dilution method is one of the methods available to estimate plasma volume , although some researchers have questioned the accuracy of this method .
-METHODS	We developed a new , physiologically based mathematical model of indocyanine green kinetics that more accurately represents indocyanine green kinetics during the first few minutes postinjection than what is assumed when using the traditional mono-exponential back-extrapolation method .
-METHODS	The mathematical model is used to develop an optimal back-extrapolation method for estimating plasma volume based on simulated indocyanine green kinetics obtained from the physiological model .
-RESULTS	Results from a clinical study using the indocyanine green dilution method in 36 subjects with type 2 diabetes indicate that the estimated plasma volumes are considerably lower when using the traditional back-extrapolation method than when using the proposed back-extrapolation method ( mean ( standard deviation ) plasma volume = 26.8 ( 5.4 ) mL/kg for the traditional method vs 35.1 ( 7.0 ) mL/kg for the proposed method ) .
-RESULTS	The results obtained using the proposed method are more consistent with previously reported plasma volume values .
-CONCLUSIONS	Based on the more physiological representation of indocyanine green kinetics and greater consistency with previously reported plasma volume values , the new back-extrapolation method is proposed for use when estimating plasma volume using the indocyanine green dilution method .
-
-###24858141
-BACKGROUND	Breastfed infants require supplementation with vitamin D ( vD ) , but little is known about the necessary dose .
-BACKGROUND	This double blind trial evaluated four different doses of vD .
-METHODS	Exclusively breastfed infants ( N = 213 ) were randomized at 1 mo to one of four doses , which they received through 9 mo while receiving no formula .
-METHODS	The supplements provided daily 200 IU , 400 IU , 600 IU , or 800 IU of vD .
-METHODS	The primary endpoint was plasma 25 ( OH ) D level , and secondary outcomes were plasma parathyroid hormone and calcium , and illness incidence .
-METHODS	The study was conducted during winter at 41 N.
-RESULTS	Most infants had low ( < 50 nmol/l ) 25 ( OH ) D levels at 1 mo , but with supplementation levels rose .
-RESULTS	Overall , levels of 25 ( OH ) D differed significantly in proportion to vD dose .
-RESULTS	There were no effects of vD on illness incidence or growth .
-RESULTS	Low levels were common , with 7.8 % of levels being < 50 nmol/l and 15 infants having 2 to 4 low levels .
-CONCLUSIONS	The four doses of vD produced different plasma levels of 25 ( OH ) D.
-CONCLUSIONS	The higher doses were somewhat more efficacious in maintaining vD sufficiency in breastfed infants .
-CONCLUSIONS	The findings support the recommended dose of 400 IU/d , and stress the need to start supplementation at birth .
-
-###24299929
-BACKGROUND	It has been suggested that the development of maternal fever during epidural analgesia could be due to intrapartum infection .
-BACKGROUND	We investigated whether antibiotic prophylaxis before epidural placement decreases the rate of epidural-related fever .
-METHODS	In this double-blind , placebo-controlled trial , 400 healthy nulliparous women requesting epidural analgesia were randomly assigned to receive either cefoxitin 2 g or placebo immediately preceding initiation of epidural labor analgesia .
-METHODS	Maternal tympanic temperature was measured hourly , and intrapartum fever was defined as a maternal temperature of 38C .
-METHODS	Neonates born to women with fever were evaluated for possible sepsis , and available placentas were evaluated for the presence of neutrophilic inflammation .
-METHODS	The primary outcome was maternal fever during epidural analgesia .
-RESULTS	Thirty-eight percent of women in the cefoxitin group and 40 % of women in the placebo group developed fever ( P = 0.68 ) .
-RESULTS	The risk difference ( 95 % confidence interval ) for fever 38C during labor ( antibiotic versus placebo ) was -2.0 % ( -11.5 to 7.5 ) , and for fever > 39C during labor was -1.5 % ( -4.7 to 1.7 ) .
-RESULTS	Approximately half of each study group had placental neutrophilic inflammation , but administration of cefoxitin had no significant effect on any grade of neutrophilic inflammation .
-RESULTS	Fever developed significantly more often in the women with placental neutrophilic inflammation compared with those without such inflammation ( 73/158 vs 33/144 , P < 0.001 ; risk difference 23 % [ 95 % confidence interval , 13.0-34 .0 ] ) .
-RESULTS	There were no significant differences in any neonatal outcomes between the antibiotic and placebo study groups .
-RESULTS	Sepsis was not diagnosed in any of the infants .
-RESULTS	There were no neonatal deaths .
-CONCLUSIONS	Fever during labor epidural analgesia is associated with placental inflammation , but fever and placental inflammation were not reduced with antibiotic prophylaxis .
-CONCLUSIONS	This finding suggests that infection is unlikely to be the cause in its development .
-
-###24610803
-OBJECTIVE	To determine whether the use of quantitative personal exposure measurements in experimental research would result in better estimates of the associations between static and time-varying magnetic field exposure and neurocognitive test performance than when exposure categories were based solely on distance to the magnetic field source .
-METHODS	In our original analysis , based on distance to the magnet of a 7 T MRI scanner , an effect of exposure to static magnetic fields was observed .
-METHODS	We performed a sensitivity analysis of test performance on a reaction task and line bisection task with different exposure measures that were derived from personal real-time measurements .
-RESULTS	The exposure measures were highly comparable , and almost all models resulted in significant associations between exposure to time-varying magnetic fields within a static magnetic field and performance on a reaction and line bisection task .
-CONCLUSIONS	In a controlled experimental setup , distance to the bore is a good proxy for personal exposure when placing subjects at fixed positions with standardized head movements in the magnetic stray fields of a 7 T MRI .
-CONCLUSIONS	Use of a magnetic field dosimeter is , however , important for estimating quantitative exposure response associations .
-
-###24691094
-OBJECTIVE	The aim of this study was to compare biweekly and monthly evolocumab with placebo and oral ezetimibe in patientswith hypercholesterolemia in a phase III trial .
-BACKGROUND	Evolocumab , a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , significantly reduced LDL-C in phase II trials .
-METHODS	Patients 18 to 80 years of age with fasting low-density lipoprotein cholesterol ( LDL-C ) 100 and < 190 mg/dl and Framingham risk scores10 % were randomized ( 1:1:1:1:2:2 ) to oral placebo and subcutaneous ( SC ) placebo biweekly ; oral placebo and SC placebo monthly ; ezetimibe and SC placebo biweekly ; ezetimibe and SC placebo monthly ; oral placebo and evolocumab 140 mg biweekly ; or oral placebo and evolocumab 420 mg monthly .
-RESULTS	A total of 614 patients were randomized and administered doses .
-RESULTS	Evolocumab treatment reduced LDL-C from baseline , on average , by 55 % to 57 % more than placebo and 38 % to 40 % more than ezetimibe ( p < 0.001 for all comparisons ) .
-RESULTS	Evolocumab treatment also favorably altered other lipoprotein levels .
-RESULTS	Treatment-emergent adverse events ( AEs ) , muscle-related AEs , and laboratory abnormalities were comparable across treatment groups .
-CONCLUSIONS	In the largest monotherapy trial using a PCSK9 inhibitor to date , evolocumab yielded significant LDL-C reductions compared with placebo or ezetimibe and was well tolerated in patients with hypercholesterolemia .
-CONCLUSIONS	( Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing LipidLevels-2 [ MENDEL-2 ] ; NCT01763827 ) .
-
-###25887744
-BACKGROUND	The modern classroom is an inherently sedentary environment .
-BACKGROUND	Virtual Field Trips ( VFTs ) using interactive whiteboards to explore virtual scenes are a potential method of converting sedentary class-time into physically active teaching .
-BACKGROUND	This pilot aimed to assess the effects of a developed VFT on physical activity and learning in primary-school children .
-METHODS	Participants ( n = 85 ) were randomly assigned to a ) a 30-minute physically active London 2012 Olympics-themed VFT , or b ) a 30-minute sedentary version of the same VFT .
-METHODS	Activity was measured using GT1M Actigraphs , content recall was assessed with a quiz and user evaluations were gained from teacher and pupil questionnaires .
-RESULTS	Pupils in the active VFT displayed significantly less sedentary time ( p < 0.001 ) , and significantly more light ( p < 0.001 ) , moderate ( p = 0.01 ) and vigorous physical activity ( p < 0.001 ) than sedentary VFT pupils .
-RESULTS	No differences in content recall were found between intervention groups : suggesting that adding physical activity into classroom teaching may not compromise attainment .
-RESULTS	High acceptability was found in teachers and active VFT students rated their session significantly higher than sedentary pupils ( p < 0.002 ) .
-CONCLUSIONS	This one-day pilot provides early evidence of the ability of VFTs to convert sedentary academic time into active time .
-CONCLUSIONS	Longitudinal research is needed to assess prolonged effects of active VFTs in reducing sedentary time .
-
-###25083090
-OBJECTIVE	To compare biofeedback-guided pelvic floor exercise therapy ( BFT ) with the use of oral polyethylene glycol ( PEG ) for the treatment of obstructive defecation .
-METHODS	A total of 88 subjects were assigned to treatment with either BFT ( n = 44 ) or oral PEG ( n = 44 ) .
-METHODS	Constipation symptoms ( including difficult evacuation , hard stool , digitation necessity , incomplete emptying sensation , laxative dependence , perianal pain at defecation , and constipation satisfaction ) , Wexner Scores , and quality of life scores were assessed after 1 , 3 , and 6 mo. .
-RESULTS	At the 6 mo follow-up , the symptoms of the BFT group patients showed significantly greater improvements compared with the PEG group regarding difficult evacuation , hard stools , digitation necessity , laxative dependence , perianal pain at defecation , constipation satisfaction , Wexner Constipation Score , and quality of life score ( P < 0.05 ) .
-RESULTS	The quality of life score of the BFT group at the final follow-up time ( 6 mo ) was 80 2.2 .
-RESULTS	After a complete course of training , improvements in the clinical symptoms of the BFT group were markedly improved ( P < 0.05 ) , and the Wexner Constipation Scores were greatly decreased compared with the oral PEG group ( P < 0.05 ) .
-CONCLUSIONS	We concluded that manometric biofeedback-guided pelvic floor exercise training is superior to oral polyethylene glycol therapy for obstructive defecation .
-
-###25239028
-BACKGROUND	The ability to physically perform at high altitude may require unique strategies to acclimatize before exposure .
-BACKGROUND	The effect of acute hypoxic exposure on the metabolic response of the skeletal muscle may provide insight into the value of short-term preacclimatization strategies .
-OBJECTIVE	To determine the human skeletal muscle response to a single acute bout of exercise in a hypoxic environment on metabolic gene expression .
-METHODS	Eleven recreationally active male participants ( 24 4 years , 173 20 cm , 82 12 kg , 15.2 7.1 % fat , 4.0 0.6 L/min maximal oxygen consumption ) completed two 1-hour cycling exercise trials at 60 % of peak power followed by 4 hours of recovery in ambient environmental conditions ( 975 m ) and at normobaric hypoxic conditions simulating 3000 m in a randomized counterbalanced order .
-METHODS	Muscle biopsies were obtained from the vastus lateralis before exercise and 4 hours after exercise for real-time polymerase chain reaction analysis of select metabolic genes .
-RESULTS	Gene expression of hypoxia-inducible factor 1 alpha , cytochrome c oxidase subunit 4 , peroxisome proliferator-activated receptor gamma coactivator 1 alpha , hexokinase , phosphofructokinase , mitochondrial fission 1 , and mitofusin-2 increased with exercise ( P < .05 ) but did not differ with hypoxic exposure ( P > .05 ) .
-RESULTS	Optic atrophy 1 did not increase with exercise or differ between environmental conditions ( P > .05 ) .
-CONCLUSIONS	The improvements in mitochondrial function reported with intermittent hypoxic training may not be explained by a single acute hypoxic exposure , and thus it appears that a longer period of preacclimatization than a single exposure may be required .
-
-###26026121
-OBJECTIVE	The current phase II clinical study was conducted to evaluate the efficacy and safety of weekly docetaxel alone , and weekly docetaxel-plus-oxaliplatin , as a second-line chemotherapy in patients with cisplatin-refractory advanced gastric cancer .
-METHODS	We enrolled patients with histologically confirmed gastric adenocarcinoma whose disease had progressed after cisplatin-based regimens .
-METHODS	Patients were randomly assigned to receive docetaxel alone ( 36 mg/m ( 2 ) , days 1 and 8 ) or docetaxel ( 36 mg/m ( 2 ) , days 1 and 8 ) and oxaliplatin ( 80 mg/m ( 2 ) , day 1 ) combination therapy every three weeks .
-RESULTS	This trial was terminated early due to poor patient accrual rate .
-RESULTS	From January 2009 to January 2012 , a total of 52 patients were enrolled in the current study from six centers : 27 patients in the docetaxel monotherapy arm and 25 patients in the docetaxel/oxaliplatin combination arm .
-RESULTS	Fifty-two patients were assessable for efficacy , and response rates as follows ( response rate : 14.8 % in the monotherapy arm , 24.0 % in the combination arm ; disease control rate : 48.1 % in the monotherapy arm , 76.0 % in the combination arm .
-RESULTS	The median progression-free survival was 2.0 ( 95 % confidence interval = 1.2-2 .9 ) months in the monotherapy arm and 4.9 ( 95 % confidence interval = 3.6-6 .6 ) months in the combination arm ( p = 0.002 ) .
-RESULTS	The most common grade 3 or 4 adverse event was neutropenia ( 14 % for monotherapy versus 32 % for combination ) .
-RESULTS	No treatment-related mortality was observed .
-CONCLUSIONS	Weekly docetaxel and weekly docetaxel-plus-oxalipaltin regimens were found to be well-tolerated and effective as a second-line chemotherapy for patients with advanced gastric cancer .
-
-###25714615
-BACKGROUND	We conducted a placebo-controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome ( BOS ) post lung transplantation .
-METHODS	We compared azithromycin ( 250mg alternate days , 12weeks ) with placebo .
-METHODS	Primary outcome was FEV1 change at 12weeks .
-RESULTS	48 patients were randomised ; ( 25 azithromycin , 23 placebo ) .
-RESULTS	It was established , post randomisation that two did not have BOS .
-RESULTS	46 patients were analysed as intention to treat ( ITT ) with 33 ` Completers ' .
-RESULTS	ITT analysis included placebo patients treated with open-label azithromycin after study withdrawal .
-RESULTS	The ITT analysis ( n = 46 , 177 observations ) estimated mean difference in FEV1 between treatments ( azithromycin minus placebo ) was 0.035 L , with a 95 % CI of -0.112 L to 0.182 L ( p = 0.6 ) .
-RESULTS	Five withdrawals , who were identified at the end of the study as having been randomised to placebo ( four with rapid loss in FEV1 , one withdrawn consent ) had received rescue open-label azithromycin , with improvement in subsequent FEV1 at 12weeks .
-RESULTS	Study Completers showed an estimated mean difference in FEV1 between treatment groups ( azithromycin minus placebo ) of 0.278 L , with 95 % CI for the mean difference : 0.170 L to 0.386 L ( p = < 0.001 ) .
-RESULTS	Nine of 23 ITT patients in the azithromycin group had 10 % gain in FEV1 from baseline .
-RESULTS	No patients in the placebo group had 10 % gain in FEV1 from baseline while on placebo ( p = 0.002 ) .
-RESULTS	Seven serious adverse events , three azithromycin , four in the placebo group , were deemed unrelated to study medication .
-CONCLUSIONS	Azithromycin therapy improves FEV1 in patients with BOS and appears superior to placebo .
-CONCLUSIONS	This study strengthens evidence for clinical practice of initiating azithromycin therapy in BOS .
-BACKGROUND	EU-CTR , 2006-000485-36 / GB .
-
-###24658598
-BACKGROUND	Patients with high Rockall scores have increased risk of ulcer rebleeding after 3-day esomeprazole infusions .
-OBJECTIVE	To investigate whether double oral esomeprazole given after a 3-day esomeprazole infusion decreases ulcer rebleeding for patients with high Rockall scores .
-METHODS	We prospectively enrolled 293 patients with peptic ulcer bleeding who had achieved endoscopic haemostasis .
-METHODS	After a 3-day esomeprazole infusion , patients with Rockall scores 6 were randomised into the oral double-dose group ( n = 93 ) or the oral standard-dose group ( n = 94 ) to receive 11days of oral esomeprazole 40mg twice daily or once daily , respectively .
-METHODS	The patients with Rockall scores < 6 served as controls ( n = 89 ) ; they received 11days of oral esomeprazole 40mg once daily .
-METHODS	Thereafter , all patients received oral esomeprazole 40mg once daily for two more weeks until the end of the 28-day study period .
-METHODS	The primary end point was peptic ulcer rebleeding .
-RESULTS	Among patients with Rockall scores 6 , the oral double-dose group had a higher cumulative rebleeding-free proportion than the oral standard-dose group ( p = 0.02 , log-rank test ) .
-RESULTS	The proportion of patients free from recurrent bleeding during the 4th-28th day in the oral double-dose group remained lower than that of the group with Rockall scores < 6 ( p = 0.03 , log-rank test ) .
-RESULTS	Among patients with Rockall scores 6 , the rebleeding rate was lower in the oral double-dose group than in the oral standard-dose group ( 4th-28th day : 10.8 % vs 28.7 % , p = 0.002 ) .
-CONCLUSIONS	Double oral esomeprazole at 40mg twice daily after esomeprazole infusion reduced recurrent peptic ulcer bleeding in high-risk patients with Rockall scores 6 .
-BACKGROUND	NCT01591083 .
-
-###24257657
-BACKGROUND	Postoperative blood loss in patients after total knee arthroplasty may cause local and systemic complications and influence clinical outcome .
-BACKGROUND	The aim of this study was to assess whether fibrin glue or tranexamic acid reduced blood loss compared with routine hemostasis in patients undergoing total knee arthroplasty .
-METHODS	A randomized , single-center , parallel , open clinical trial was performed in adult patients undergoing primary total knee arthroplasty .
-METHODS	Patients were divided into four groups .
-METHODS	Group 1 received fibrin glue manufactured by the Blood and Tissue Bank of Catalonia , Group 2 received Tissucol ( fibrinogen and thrombin ) , Group 3 received intravenous tranexamic acid , and Group 4 ( control ) had no treatment other than routine hemostasis .
-METHODS	The primary outcome was total blood loss collected in drains after surgery .
-METHODS	Secondary outcomes were the calculated hidden blood loss , transfusion rate , preoperative and postoperative hemoglobin , number of blood units transfused , adverse events , and mortality .
-RESULTS	One hundred and seventy-two patients were included .
-RESULTS	The mean total blood loss ( and standard deviation ) collected in drains was 553.9 321.5 mL for Group 1 , 567.8 299.3 mL for Group 2 , 244.1 223.4 mL for Group 3 , and 563.5 269.7 mL for Group 4 .
-RESULTS	In comparison with the control group , Group 3 had significantly lower total blood loss ( p < 0.001 ) , but it was not significantly lower in Groups 1 and 2 .
-RESULTS	The overall rate of patients who had a blood transfusion was 21.1 % ( thirty-five of 166 patients analyzed per protocol ) .
-RESULTS	Two patients required transfusion in Group 3 compared with twelve patients in Group 4 ( p = 0.015 ) .
-RESULTS	No significant difference was observed between the two fibrin glue groups and the control group with regard to the need for transfusion .
-RESULTS	There was no difference between groups with regard to the percentage of adverse events .
-CONCLUSIONS	Neither type of fibrin glue was more effective than routine hemostasis in reducing postoperative bleeding and transfusion requirements , and we no longer use them .
-CONCLUSIONS	However , this trial supports findings from previous studies showing that intravenous tranexamic acid can decrease postoperative blood loss .
-
-###26193635
-BACKGROUND	Type 1 diabetes ( T1D ) results from destruction of pancreatic cells by autoreactive effector T cells .
-BACKGROUND	We hypothesized that the immunomodulatory drug alefacept would result in targeted quantitative and qualitative changes in effector T cells and prolonged preservation of endogenous insulin secretion by the remaining cells in patients with newly diagnosed T1D .
-METHODS	In a multicenter , randomized , double-blind , placebo-controlled trial , we compared alefacept ( two 12-week courses of 15 mg/wk i.m. , separated by a 12-week pause ) with placebo in patients with recent onset of T1D .
-METHODS	Endpoints were assessed at 24 months and included meal-stimulated C-peptide AUC , insulin use , hypoglycemic events , and immunologic responses .
-RESULTS	A total of 49 patients were enrolled .
-RESULTS	At 24 months , or 15 months after the last dose of alefacept , both the 4-hour and the 2-hour C-peptide AUCs were significantly greater in the treatment group than in the control group ( P = 0.002 and 0.015 , respectively ) .
-RESULTS	Exogenous insulin requirements were lower ( P = 0.002 ) and rates of major hypoglycemic events were about 50 % reduced ( P < 0.001 ) in the alefacept group compared with placebo at 24 months .
-RESULTS	There was no apparent between-group difference in glycemic control or adverse events .
-RESULTS	Alefacept treatment depleted CD4 + and CD8 + central memory T cells ( Tcm ) and effector memory T cells ( Tem ) ( P < 0.01 ) , preserved Tregs , increased the ratios of Treg to Tem and Tcm ( P < 0.01 ) , and increased the percentage of PD-1 + CD4 + Tem and Tcm ( P < 0.01 ) .
-CONCLUSIONS	In patients with newly diagnosed T1D , two 12-week courses of alefacept preserved C-peptide secretion , reduced insulin use and hypoglycemic events , and induced favorable immunologic profiles at 24 months , well over 1 year after cessation of therapy .
-BACKGROUND	https://clinicaltrials.gov/ NCT00965458 .
-BACKGROUND	NIH and Astellas .
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-###24548278
-OBJECTIVE	Millions of patients were treated with the sirolimus-eluting Cypher and the paclitaxel-eluting Taxus coronary stents with potential late-occurring increase in event rates .
-OBJECTIVE	Therefore , the long-term outcome follow-up is of major clinical interest .
-METHODS	In total , 2.098 unselected patients with ST-segment elevation myocardial infarction ( STEMI ) , non-STEMI , stable or unstable angina pectoris were randomized to receive Cypher ( n = 1.065 ) or Taxus ( n = 1.033 ) stents and were followed for 5 years .
-RESULTS	The primary end-point ; the composite of cardiac death , myocardial infarction and target vessel revascularization ( major adverse cardiac event , MACE ) , occurred in 467 patients ( 22.3 % ) ; Cypher n = 222 ( 20.8 % ) , Taxus n = 245 ( 23.7 % ) , ns .
-RESULTS	Definite and probable stent thrombosis occurred in 107 patients ( 5.1 % ) ; Cypher n = 51 ( 4.8 % ) , Taxus n = 56 ( 5.4 % ) , ns .
-RESULTS	No statistically significant differences were found in the elements of the primary end-point or in other secondary end-points between the two stent groups .
-RESULTS	After one year , the annual rates of stent thrombosis and MACE remained constant .
-CONCLUSIONS	During 5-year follow-up , the Cypher and the Taxus coronary stents had similar clinical outcome with no signs of increasing rates of adverse events over time .
-
-###26352813
-BACKGROUND	Lysosomal acid lipase is an essential lipid-metabolizing enzyme that breaks down endocytosed lipid particles and regulates lipid metabolism .
-BACKGROUND	We conducted a phase 3 trial of enzyme-replacement therapy in children and adults with lysosomal acid lipase deficiency , an underappreciated cause of cirrhosis and severe dyslipidemia .
-METHODS	In this multicenter , randomized , double-blind , placebo-controlled study involving 66 patients , we evaluated the safety and effectiveness of enzyme-replacement therapy with sebelipase alfa ( administered intravenously at a dose of 1 mg per kilogram of body weight every other week ) ; the placebo-controlled phase of the study was 20 weeks long and was followed by open-label treatment for all patients .
-METHODS	The primary end point was normalization of the alanine aminotransferase level .
-METHODS	Secondary end points included additional disease-related efficacy assessments , safety , and side-effect profile .
-RESULTS	Substantial disease burden at baseline included a very high level of low-density lipoprotein cholesterol ( 190 mg per deciliter ) in 38 of 66 patients ( 58 % ) and cirrhosis in 10 of 32 patients ( 31 % ) who underwent biopsy .
-RESULTS	A total of 65 of the 66 patients who underwent randomization completed the double-blind portion of the trial and continued with open-label treatment .
-RESULTS	At 20 weeks , the alanine aminotransferase level was normal in 11 of 36 patients ( 31 % ) in the sebelipase alfa group and in 2 of 30 ( 7 % ) in the placebo group ( P = 0.03 ) , with mean changes from baseline of -58 U per liter versus -7 U per liter ( P < 0.001 ) .
-RESULTS	With respect to prespecified key secondary efficacy end points , we observed improvements in lipid levels and reduction in hepatic fat content ( P < 0.001 for all comparisons , except P = 0.04 for triglycerides ) .
-RESULTS	The number of patients with adverse events was similar in the two groups ; most events were mild and were considered by the investigator to be unrelated to treatment .
-CONCLUSIONS	Sebelipase alfa therapy resulted in a reduction in multiple disease-related hepatic and lipid abnormalities in children and adults with lysosomal acid lipase deficiency .
-CONCLUSIONS	( Funded by Synageva BioPharma and others ; ARISE ClinicalTrials.gov number , NCT01757184 . )
-
-###24509965
-BACKGROUND	Cryosurgery is the most common treatment for actinic keratosis ( AK ) in the United States .
-BACKGROUND	Efficacy with cryosurgery is variable , and is a modality for treating individual , visible lesions while failing to treat subclinical lesions .
-METHODS	FIELD Study 1 ( NCT01541553 ) is a phase 3 , multicenter , randomized , double-blind study that evaluated the short - ( 11-week ) and long - ( 12-month ) term efficacy and safety of sequential AK treatment using cryosurgery with liquid nitrogen followed by ingenol mebutate gel , versus cryosurgery followed by vehicle .
-RESULTS	Overall , 329 patients were randomized to ingenol mebutate 0.015 % gel ( n = 167 ) or vehicle ( n = 162 ) 3 weeks after cryosurgery .
-RESULTS	Baseline characteristics were balanced across groups .
-RESULTS	At week 11 , complete clearance rate ( 100 % ) in the treatment area was higher for ingenol mebutate gel compared with vehicle ( 60.5 % vs 49.4 % , respectively ; P = .04 ) .
-RESULTS	Mean percentage reduction in number of AKs versus baseline was also numerically higher for ingenol mebutate gel ( 82.7 % vs 75.6 % ) .
-RESULTS	A general reduction from baseline lesion count was observed 3 weeks after cryosurgery .
-RESULTS	Treatment after cryosurgery was well tolerated .
-CONCLUSIONS	Short-term ( 11-week ) AK clearance rates on the face or scalp with ingenol mebutate gel after cryosurgery were higher than with cryosurgery alone .
-
-###25068219
-OBJECTIVE	To evaluate the contraction pattern of masticatory muscles during sustained clenching tasks with or without experimental pain induced by glutamate injection into the masseter muscle .
-OBJECTIVE	It was hypothesized that acute muscle pain could induce compensatory changes in the electromyographic ( EMG ) activity of the masticatory muscles .
-METHODS	Fifteen volunteers ( seven males , mean age SD = 29.7 1.1 years ; eight females , mean age SD = 23.5 1.2 years ) were recruited in a crossover experimental study .
-METHODS	All subjects participated in two randomized 20-minute experimental sessions .
-METHODS	Each subject was asked to clench at 25 % of the maximum voluntary contraction ( MVC ) .
-METHODS	After 10 minutes , isotonic saline or glutamate was injected in random order into the right masseter .
-METHODS	EMG activity ( root mean square [ RMS ] and mean power frequency [ MPF ] ) was assessed in the masseter and anterior temporalis muscles on both sides .
-METHODS	Pain and fatigue were assessed by 0-10 numeric rating scales ( NRS ) every minute .
-METHODS	Differences between conditions ( isotonic saline vs glutamate ) for all the outcome parameters were analyzed by using a mixed effect model .
-RESULTS	The EMG activity of the masticatory muscles and pain and fatigue scores were not dependent on isotonic saline/glutamate injection ( all P > .05 ) .
-RESULTS	The RMS in the temporalis and masseter muscles increased with time ( right masseter P = 0.001 , left masseter P = .004 , right temporalis P = .22 , left temporalis P = .006 ) , whereas the MPF decreased ( right masseter P = .0001 , left masseter P < .0001 , right temporalis P = .51 , left temporalis P = .0005 ) .
-RESULTS	Scores for fatigue and pain increased during the experimental sessions ( all P < .05 ) .
-CONCLUSIONS	Intramuscular injection of glutamate caused more pain than isotonic saline but did not affect the contraction pattern of the masticatory muscles during a sustained clenching task .
-CONCLUSIONS	This finding strongly suggests the adaptive capacity of the stomatognathic system in the presence of acute nociceptive inputs .
-
-###24755139
-BACKGROUND	The purpose of this study was to investigate the hypothesis that dietary supplementation with rice bran fermented with Lentinus edodes ( rice bran exo-biopolymer , RBEP ) , a substance known to contain arabinoxylan , enhances natural killer ( NK ) cell activity and modulates cytokine production in healthy adults .
-METHODS	This study was designed in a randomized , double-blind , placebo-controlled , and parallel-group format .
-METHODS	Eighty healthy participants with white blood cell counts of 4,000-8 ,000 cells/L were randomly assigned to take six capsules per day of either 3 g RBEP or 3 g placebo for 8 weeks .
-METHODS	Three participants in the placebo group were excluded after initiation of the protocol ; no severe adverse effects from RBEP supplementation were reported .
-METHODS	NK cell activity of peripheral blood mononuclear cells was measured using nonradioactive cytotoxicity assay kits and serum cytokine concentrations included interferon ( IFN ) - , tumor necrosis factor ( TNF ) - , interleukin ( IL ) -2 , IL-4 , IL-10 , and IL-12 were measured by Bio-Plex cytokine assay kit .
-METHODS	This study was registered with the Clinical Research Information Service ( KCT0000536 ) .
-RESULTS	Supplementation of RBEP significantly increased IFN - production compared with the placebo group ( P = 0.012 ) .
-RESULTS	However , RBEP supplementation did not affect either NK cell activity or cytokine levels , including IL-2 , IL-4 , IL-10 , IL-12 , and TNF - , compared with the placebo group .
-CONCLUSIONS	The data obtained in this study indicate that RBEP supplementation increases IFN - secretion without causing significant adverse effects , and thus may be beneficial to healthy individuals .
-CONCLUSIONS	This new rice bran-derived product may therefore be potentially useful to include in the formulation of solid and liquid foods designed for treatment and prevention of pathological states associated with defective immune responses .
-
-###24379001
-BACKGROUND	Inflammation contributes to the pathogenesis of psoriasis as well as atrial fibrillation .
-BACKGROUND	The impact of psoriasis and its association with new-onset atrial fibrillation was assessed in hypertensive patients with left ventricular hypertrophy ( LVH ) .
-METHODS	The predictive value of baseline or incident psoriasis for new-onset atrial fibrillation was evaluated in 7099 hypertensive patients with electrocardiographic LVH with no history of atrial fibrillation or other cardiovascular disease , in sinus rhythm on their baseline electrocardiogram .
-RESULTS	A total of 154 patients ( 2.2 % ) had or developed psoriasis and new-onset atrial fibrillation occurred in 506 patients ( 7.1 % ) during a mean follow-up of 4.7 1.1 years .
-RESULTS	At baseline , the psoriasis patients were younger ( 65 7 vs. 67 7 years ) and had less left ventricle hypertrophy by ECG Sokolow-Lyon voltage ( 27.6 9.7 vs. 30.1 10.4 mm ) ; higher hemoglobin ( 6.3 2.2 vs. 6.0 2.7 mmol/l ) and prevalence of diabetes ( 20.6 vs. 12.8 % , P 0.004 ) than patients without psoriasis .
-RESULTS	In multivariable Cox analysis , adjusting for age , sex , hemoglobin , diabetes , time-varying SBP , heart rate , study treatment and Sokolow-Lyon hypertrophy , psoriasis , treated as a time-varying covariate , was associated with a two-fold higher risk of new-onset atrial fibrillation [ hazard ratio : 1.97 ( 95 % confidence interval ( CI ) : 1.18-3 .30 ) , P = 0.01 ] .
-RESULTS	Propensity-matched analysis yielded similar results ( odds ratio : 3.49 , 95 % CI 1.24-9 .81 , P = 0.018 ) .
-CONCLUSIONS	Psoriasis has a similar prevalence in hypertensive patients as in the general population .
-CONCLUSIONS	Psoriasis independently predicted new-onset atrial fibrillation despite lower age and electrocardiographic LVH in psoriasis patients than in patients without psoriasis .
-
-###24708578
-BACKGROUND	Many patients with relapsing-remitting multiple sclerosis ( MS ) treated with high-dose interferon - ( IFN ) develop serum binding antibodies ( BAb ) and neutralizing antibodies ( NAb ) .
-BACKGROUND	NAb reduces the biological activity of IFN , which contributes to clinical failure in these patients .
-BACKGROUND	We investigated whether access to antibody ( Ab ) test results would alter usual care of ( IFN ) - treated patients and whether BAb could predict NAb .
-METHODS	This was a randomized , controlled , open-label , parallel-group , multicenter study in patients with multiple sclerosis .
-METHODS	Subjects ( n = 1358 ) were randomly assigned to Ab testing or usual care .
-METHODS	BAb and NAb titres were measured using standard assays .
-METHODS	Primary and secondary outcomes were the proportion of patients whose IFN therapy changed and the type of and reasons for therapy changes .
-RESULTS	Therapy changes differed between the Ab testing and usual care arms ( 19.6 % and 14.0 % , respectively ; p = 0004 ) .
-RESULTS	Results from Ab testing were more frequently reported as the reason for therapy change in the Ab testing arm than in the usual care arm ( p < 0.0001 ) .
-RESULTS	NAb and BAb positivity significantly increased the likelihood of therapy change and reduced IFN-associated adverse events .
-RESULTS	BAb titres were a significant predictor of NAb positivity ( p = 0.0012 ) .
-RESULTS	Initial BAb-positive and NAb-positive status in both study arms had a significant impact on the overall number of patients with a therapy change ( p < 0.05 ) .
-CONCLUSIONS	Access to Ab test results impacted therapy management .
-CONCLUSIONS	BAb titres can predict NAb positivity in patients on high-dose IFN .
-
-###24364175
-OBJECTIVE	The aim of this report was to clinically and radiographically evaluate changes to the hard and soft tissues around implants placed in extraction sockets grafted with medical grade calcium sulfate hemihydrate ( MGCSH ) mixed with platelet-rich plasma ( PRP ) and a collagen resorbable plug after one year of function .
-METHODS	This evaluation was part of a previous study conducted to evaluate extraction socket grafts .
-METHODS	Fourteen subjects out of 16 were evaluated .
-METHODS	After tooth extraction , eight subjects received MGCSH mixed with PRP in the extraction sockets ( test group ) , and six subjects received collagen resorbable plug dressing material ( control group ) .
-METHODS	After three months of bone healing , dental implants were placed .
-METHODS	Three months after implant installation , provisional restorations were placed and implants were loaded in function for one month followed by definitive restorations .
-METHODS	Follow-up examinations and intraoral digital radiographs were made at baseline and one year after definitive restorations to evaluate the marginal bone level in each subject .
-RESULTS	At the one-year follow-up , the survival and success rate was 100 % for all implants .
-RESULTS	There was no statistically significant difference in the amount of vertical bone loss between groups after 1 year ( p > 0.05 ) .
-RESULTS	For the test group , there was a mean mesial bone loss of -0.8 + / - 0.6 mm and a mean distal bone loss of -0.5 + / - 0.4 mm .
-RESULTS	For the control group , there was a mean mesial bone loss of -1.1 + / - 0.7 mm and a mean distal bone loss of -0.6 + / - 0.6 mm .
-CONCLUSIONS	At the one-year follow-up , the implant placement in grafted sockets was not affected by the type of the graft material .
-CONCLUSIONS	Implants placed in sockets grafted with MGCSH mixed with PRP showed less marginal bone loss after one year in comparison to those with collagen resorbable grafts .
-
-###24908551
-BACKGROUND	Patients with HIV on antiretroviral therapy might benefit from regimen simplification to reduce pill burden and dosing frequency .
-BACKGROUND	We aimed to assess the safety and efficacy of simplifying the treatment regimen for adults with virologically suppressed HIV infection from a ritonavir-boosted protease inhibitor and emtricitabine plus tenofovir disoproxil fumarate ( tenofovir ) regimen to coformulated elvitegravir , cobicistat , emtricitabine , and tenofovir .
-METHODS	STRATEGY-PI is a 96 week , international , multicentre , randomised , open-label , phase 3b trial in which HIV-infected adults with a plasma HIV-1 RNA viral load of less than 50 copies per mL for at least 6 months who were taking a ritonavir-boosted protease inhibitor with emtricitabine plus tenofovir were randomly assigned ( 2:1 ) either to switch to coformulated elvitegravir , cobicistat , emtricitabine , and tenofovir or to continue on their existing regimen .
-METHODS	Key eligibility criteria included no history of virological failure , no resistance to emtricitabine and tenofovir , and creatinine clearance of 70 mL/min or higher .
-METHODS	Neither participants nor investigators were masked to group allocation .
-METHODS	The primary endpoint was the proportion of participants with a viral load of less than 50 copies per mL at week 48 , based on a US Food and Drug Administration snapshot algorithm for the modified intention-to-treat population , which excluded major protocol violations ( prohibited resistance or not receiving a protease inhibitor at baseline ) .
-METHODS	We prespecified non-inferiority with a 12 % margin ; if non-inferiority was established , superiority was tested as per a prespecified sequential testing procedure .
-METHODS	This trial is registered at ClinicalTrials.gov , number NCT01475838 .
-RESULTS	Between Dec 12 , 2011 , and Dec 20 , 2012 , 433 participants were randomly assigned and received at least one dose of study drug .
-RESULTS	Of these participants , 293 were assigned to switch to the simplified regimen ( switch group ) and 140 to remain on their existing regimen ( no-switch group ) ; after exclusions , 290 and 139 participants , respectively , were analysed in the modified intention-to-treat population .
-RESULTS	At week 48 , 272 ( 938 % ) of 290 participants in the switch group maintained a viral load of less than 50 copies per mL , compared with 121 ( 871 % ) of 139 in the no-switch group ( difference 67 % , 95 % CI 04-137 ; p = 0025 ) .
-RESULTS	The statistical superiority of the simplified regimen was mainly caused by a higher proportion of participants in the no-switch group than in the switch group discontinuing treatment for non-virological reasons ; virological failure was rare in both groups ( two [ 1 % ] of 290 vs two [ 1 % ] of 139 ) .
-RESULTS	We did not detect any treatment-emergent resistance in either group .
-RESULTS	Adverse events leading to discontinuation were rare in both groups ( six [ 2 % ] of 293 vs four [ 3 % ] of 140 ) .
-RESULTS	Switching to the simplified regimen was associated with a small , non-progressive increase from baseline in serum creatinine concentration .
-RESULTS	Nausea was more common in the switch group than in the no-switch group , but rates of diarrhoea and bloating decreased compared with baseline from week 4 to week 48 in the switch group , whereas there were generally no changes for these symptoms in the no-switch group .
-CONCLUSIONS	Coformulated elvitegravir , cobicistat , emtricitabine , and tenofovir might be a useful regimen simplification option for virologically supressed adults with HIV taking a multitablet ritonavir-boosted protease inhibitor regimen .
-BACKGROUND	Gilead Sciences .
-
-###25391006
-OBJECTIVE	The aim of this study is to assess the efficacy of an initial dose of ribavirin administered before a 48-week course of treatment with peg-IFN + ribavirin in treatment-nave patients and in patients after previous failure of CHC treatment .
-METHODS	A total of 103 patients with chronic hepatitis C infected with genotype 1 HCV were qualified to the study .
-METHODS	Study patients were randomised to receive one of two treatments : A - RBV for 4 weeks followed by combined therapy with peg-IFN alpha-2a + RBV for 48 weeks ( n = 73 ) , or B - combined therapy with peg-IFN alpha-2a + RBV for 48 weeks ( n = 30 ) .
-RESULTS	SVR 24 was observed in 44 % patients in group A and in group 40 % patients in group B ( 40 % ) , p > 0.05 .
-RESULTS	Comparing subgroups of the naive patients , it was found that the SVR24 value was higher in group A than group B ( 57 % vs. 47 % , p > 0.05 ) .
-RESULTS	In the re-therapy subgroups , higher treatment response rates in patients not responding earlier was found in group A than group B ( 39 % vs. 16 % , p > 0.05 ) .
-CONCLUSIONS	No significant advantage was found in the use of a priming method over a standard regimen .
-CONCLUSIONS	However , it could be recommended in patients with a total lack of response to peg-IFN and ribavirin when no other therapeutic options are available .
-
-###24967813
-OBJECTIVE	Vitamin D deficiency affects 1 billion people globally .
-OBJECTIVE	It has an important role in bone homeostasis , brain development and modulation of the immune system and yet the impact of antenatal vitamin D deficiency on infant outcomes is poorly understood .
-OBJECTIVE	We assessed the association of 25 - hydroxyvitamin D levels ( 25-OHD ) in late pregnancy and early infant growth and developmental outcomes in rural Vietnam .
-METHODS	A prospective cohort study of 960 women who had previously participated in a double-blind cluster randomized controlled trial of antenatal micronutrient supplementation in rural Vietnam was undertaken .
-METHODS	Maternal 25-OHD concentration was measured at 32 weeks gestation , and infants were followed until 6 months of age .
-METHODS	Main outcome measures were cognitive , motor , socio-emotional and language scores using the Bayley Scales of Infant Development , 3rd edition , and infant length-for-age z scores at 6 months of age .
-RESULTS	60 % ( 582/960 ) of women had 25-OHD levels < 75 nmol/L at 32 weeks gestation .
-RESULTS	Infants born to women with 25-OHD deficiency ( < 37.5 nmol/L ) had reduced developmental language scores compared to those born to women who were vitamin D replete ( 75 nmol/L ) ( Mean Difference ( MD ) -3.48 , 95 % Confidence Interval ( CI ) -5.67 to -1.28 ) .
-RESULTS	For every 25 nmol increase in 25-OHD concentration in late pregnancy , infant length-for-age z scores at 6 months of age decreased by 0.08 ( 95 % CI -0.15 to -0.02 ) .
-CONCLUSIONS	Low maternal 25 - hydroxyvitamin D levels during late pregnancy are of concern in rural Vietnam , and are associated with reduced language developmental outcomes at 6 months of age .
-CONCLUSIONS	Our findings strengthen the evidence for giving vitamin D supplementation during pregnancy .
-
-###24798710
-BACKGROUND	Poor management of chronic medical treatments may result in severe health consequences for patients as well as costs for society .
-BACKGROUND	Non-adherence is common among patients with type 2 diabetes .
-BACKGROUND	Interventions by community pharmacists may assist in improving adherence and consequently health outcomes for patients with type 2 diabetes .
-OBJECTIVE	The study aimed to investigate whether a comprehensive and a brief individually targeted intervention for patients with type 2 diabetes could improve implementation of drug therapy in Danish community pharmacies .
-OBJECTIVE	The interventions intended to give patients more competence and support to improve adherence and self-management in order to reach treatment goals for diabetes and blood pressure as well as goals for patient perceived outcomes .
-METHODS	This study was an RCT , comparing two interventions ; basic intervention ( BI ) and extended intervention ( EI ) .
-METHODS	The intervention model sought to identify drug-related problems as well as issues experienced by patients in relation to medicines use , and consequently find individually tailored solutions to address the identified problems .
-RESULTS	The trial included five pharmacies ; five pharmacists and five pharmaconomists , and 205 patients ; BI ( 39 patients ) , EI ( 41 patients ) , Control ( 125 patients ) .
-RESULTS	Patient reported systolic blood pressure improved in both groups and significantly in the EI group compared to the control group ( P = 0.020 ) .
-RESULTS	Increase in disease-related knowledge was higher in the EI group compared to the control group ( P = 0.006 ) , but not in the BI group ( P = 0.139 ) .
-RESULTS	Except for quality of life , the EI group reported significantly higher improvement in all aspects of beneficial effects from participating in the trial when compared to the control group .
-RESULTS	No significant differences were detected for changes in hospital admissions or in doctor visits .
-RESULTS	The two intervention groups reported significantly higher satisfaction with all aspects of patient satisfaction with pharmacy staff in the project than control patients .
-CONCLUSIONS	The study showed improvement in patient health , well-being , knowledge , and satisfaction as a result of the trial , particularly for the EI group .
-CONCLUSIONS	Thus a program comprising patient narratives , problem and resource identification , and multi-dimensional individually tailored patient medication management solutions seems to be an appropriate intervention to ensure outcome improvement of non-adherent patients .
-
-###24885140
-BACKGROUND	The 4-stage approach ( 4-SA ) is used as a didactic method for teaching practical skills in international courses on resuscitation and the structured care of trauma patients .
-BACKGROUND	The aim of this study was to evaluate objective and subjective learning success of a video-assisted 4-SA in teaching undergraduate medical students .
-METHODS	The participants were medical students learning the principles of the acute treatment of trauma patients in their multidiscipline course on emergency and intensive care medicine .
-METHODS	The participants were quasi - randomly divided into two groups .
-METHODS	The 4-SA was used in both groups .
-METHODS	In the control group , all four steps were presented by an instructor .
-METHODS	In the study group , the first two steps were presented as a video .
-METHODS	At the end of the course a 5-minute objective , structured clinical examination ( OSCE ) of a simulated trauma patient was conducted .
-METHODS	The test results were divided into objective results obtained through a checklist with 9 dichotomous items and the assessment of the global performance rated subjectively by the examiner on a Likert scale from 1 to 6 .
-RESULTS	313 students were recruited ; the results of 256 were suitable for analysis .
-RESULTS	The OSCE results were excellent in both groups and did not differ significantly ( control group : median 9 , interquantil range ( IQR ) 8-9 , study group : median 9 , IQR 8-9 ; p = 0.29 ) .
-RESULTS	The global performance was rated significantly better for the study group ( median 1 , IQR 1-2 vs. median 2 , IQR 1-3 ; p < 0.01 ) .
-RESULTS	The relative knowledge increase , stated by the students in their evaluation after the course , was greater in the study group ( 85 % vs. 80 % ) .
-CONCLUSIONS	It is possible to employ video assistance in the classical 4-SA with comparable objective test results in an OSCE .
-CONCLUSIONS	The global performance was significantly improved with use of video assistance .
-
-###24875610
-OBJECTIVE	Although anti-vascular endothelial growth factor treatment of neovascular age-related macular degeneration ( AMD ) results in improved vision overall , loss of substantial vision can occur .
-OBJECTIVE	Understanding the processes that lead to loss of vision may lead to preventive strategies .
-OBJECTIVE	To determine the incidence , characteristics , causes , and baseline predictors of sustained visual acuity loss after 2 years of treatment with ranibizumab or bevacizumab for neovascular AMD .
-METHODS	A cohort study within a randomized clinical trial of participants in the Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) .
-METHODS	Participants were randomly assigned to treatment with ranibizumab or bevacizumab and to 2 years of monthly or as needed injections or monthly injections for 1 year and as needed injections the following year .
-METHODS	Sustained visual acuity loss , defined as loss of 15 or more letters from baseline at weeks 88 and 104 .
-RESULTS	Among 1030 participants , 61 eyes ( 5.9 % ) developed sustained visual acuity loss in 2 years .
-RESULTS	Within this group , visual acuity decreased gradually over time , with a mean decrease of 2 , 19 , and 33 letters from baseline at 4 weeks , 1 year , and 2 years , respectively .
-RESULTS	At 2 years , eyes with sustained visual acuity loss had more scarring ( 60.0 % vs 41.4 % , P = .007 ) , more geographic atrophy ( GA ) ( 31.6 % vs 20.7 % , P = .004 ) , larger lesions ( 16 vs 8 mm2 , P < .001 ) , and higher proportions of intraretinal fluid ( 82.5 % vs 51.0 % , P < .001 ) , subretinal hyperreflective material ( 84.5 % vs 44.2 % , P < .001 ) , retinal thinning ( 43.3 % vs 23.0 % , P < .001 ) , and thickening ( 20.0 % vs 12.1 % , P < .001 ) .
-RESULTS	Likely causes of sustained visual acuity loss included foveal scarring ( 44.3 % ) , pigmentary abnormalities ( 27.9 % ) , and foveal GA ( 11.5 % ) .
-RESULTS	Baseline factors independently associated with a higher incidence of sustained visual acuity loss were the presence of nonfoveal GA ( odds ratio [ OR ] , 2.86 ; 95 % CI , 1.35-6 .08 ; P = .006 ) , larger area of choroidal neovascularization ( OR for a > 4-disc area vs 1-disc area , 3.91 ; 95 % CI , 1.70-9 .03 ; P = .007 ) , and bevacizumab treatment ( OR , 1.83 ; 95 % CI , 1.07-3 .14 ; P = .03 ) .
-CONCLUSIONS	Sustained visual acuity loss was relatively rare in CATT .
-CONCLUSIONS	The development of foveal scar , pigmentary abnormalities , or GA contributed to most of the sustained visual acuity loss .
-CONCLUSIONS	Risk was 3 % higher among eyes treated with bevacizumab .
-CONCLUSIONS	Treatment that targeted the prevention of scarring or GA may improve vision outcomes .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00593450 .
-
-###25711157
-OBJECTIVE	To compare 2 digital flexible ureteroscopes in a randomized , prospective , clinical trial ; the complementary metal oxide semiconductor-based Gyrus ACMI/Olympus Invisio DUR-D and the charged coupled device-based Olympus URF-V .
-METHODS	Patients scheduled for ureteroscopy were prospectively enrolled and randomized between the DUR-D and URF-V .
-METHODS	Patient demographics , laser and total procedure time , laser energy , lower pole time , and difficulties encountered were recorded .
-METHODS	The visibility and maneuverability were rated on a scale of 0-10 .
-RESULTS	A total of 101 patients ( 58 women ) with a mean age of 49.5 years ( 20-80 years ) were enrolled .
-RESULTS	Laser lithotripsy ( mean stone size , 11.8 mm ) was performed in 88 patients , 10 underwent stone basketing , and 3 had diagnostic ureteroscopy .
-RESULTS	For the DUR-D and URF-V , the mean total operative time ( 26.5 vs 25 minutes ) , laser time ( 12.5 vs 13 minutes ) , lower pole time ( 9 vs 11 minutes ) , and basket time ( 14.5 vs 13 minutes ) were comparable .
-RESULTS	In 3 of 45 ( 6.6 % ) and 6 of 56 ( 10.7 % ) cases , the stone could not be reached with the DUR-D and URF-V , respectively .
-RESULTS	A fiberoptic scope ( URF-P5 ) reached the stone in all cases .
-RESULTS	On a scale of 0-10 , the mean visibility was 6.86 and 8.73 ( P < .01 ) and the maneuverability was 7.18 and 8.17 ( P < .01 ) for DUR-D and URF-V , respectively .
-RESULTS	There were 8 repairs , 4 for each scope .
-RESULTS	The DUR-D averaged 11.25 cases per repair and the URF-V averaged 14 .
-CONCLUSIONS	The URF-V offered better visibility and maneuverability compared with the DUR-D .
-CONCLUSIONS	Both had similar failure rates compared with the previous study with fiberoptic scopes .
-
-###24788974
-OBJECTIVE	Ability to perform basic daily activity represented by functional status ( FNS ) before surgery can be assessed in the clinic for determining health status of the patient .
-OBJECTIVE	We sought to study the effect of FNS on postoperative outcomes after carotid endarterectomy ( CEA ) in a national data set .
-METHODS	National Surgical Quality Improvement Project is a national data set , which includes data from > 300 hospitals .
-METHODS	Patients who underwent CEA were identified by Current Procedural Terminology code and divided into 3 categories based on FNS : independent , partially dependent , and dependent .
-METHODS	Thirty-day postoperative stroke , death , and other postoperative complications were identified as the study end point .
-METHODS	We used multivariate logistic regression to estimate odds ratio for outcomes while controlling for sex , race , diabetes mellitus , cardiovascular disease , smoking , and other confounders .
-RESULTS	Of 19 748 CEAs , 19 348 ( 97.97 % ) were functionally independent , 377 ( 1.99 % ) were functionally partially dependent , and 23 ( 0.12 % ) were functionallydependent .
-RESULTS	In functionally independent group , there were 196 ( 1.01 % ) strokes , 84 ( 0.43 % ) deaths , and 1416 ( 7.17 % ) other complications , whereas in the functionally partially dependent group , there were 14 ( 3.71 % ) strokes , 10 ( 2.65 % ) deaths , and 80 ( 21.22 % ) other complications .
-RESULTS	In multivariable risk-adjusted model , using functionally independent as reference , functionally partially dependent was associated with death ( odds ratio , 3.3 ; 95 % confidence interval , 1.6-6 .8 ; P < 0.001 ) , stroke ( odds ratio , 3 ; 95 % confidence interval , 1.7-5 .4 ; P < 0.001 ) , and other complications ( odds ratio , 2.5 ; 95 % confidence interval , 1.9-3 .2 ; P < 0.001 ) .
-CONCLUSIONS	In this national data set , patient 's inability to perform basic activities of independent living is associated with adverse postoperative outcomes after CEA .
-CONCLUSIONS	Hence , FNS should be vigilantly assessed in clinic for risk stratification along with other objective factors for gauging risk of adverse outcomes after CEA .
-
-###24284438
-BACKGROUND	Excessive weight gain during pregnancy is a risk factor for postpartum weight retention and future weight gain and obesity .
-BACKGROUND	Whether a behavioral intervention in pregnancy can reduce long-term weight retention is unknown .
-OBJECTIVE	This randomized trial tested whether a low-intensity behavioral intervention to prevent excessive gestational weight gain could increase the proportion of women who returned to prepregnancy weight by 12 mo postpartum .
-METHODS	Women ( n = 401 , 13.5 wk of gestation , 50 % normal weight , 50 % overweight/obese ) were randomly assigned into an intervention or control group ; 79 % completed the 12-mo assessment .
-METHODS	The telephone-based intervention targeted gestational weight gain , healthy eating , and exercise and was discontinued at delivery .
-RESULTS	In modified intent-to-treat analyses that excluded women with miscarriages ( n = 6 ) , gestational diabetes ( n = 32 ) , or subsequent pregnancies ( n = 32 ) , the intervention had no significant effect on the odds of achieving prepregnancy weight at 12 mo postpartum ( n = 331 ; 35.4 % compared with 28.1 % ; P = 0.18 ) .
-RESULTS	Completer analyses suggested that the intervention tended to increase the percentages of women who reached prepregnancy weight ( n = 261 ; 45.3 % compared with 35.3 % ; P = 0.09 ) and significantly reduced the magnitude of mean SD postpartum weight retained ( 1.4 6.3 compared with 3.0 5.7 kg ; P = 0.046 ) at 12 mo. .
-RESULTS	Women in the intervention group reported higher dietary restraint through 6 mo postpartum ( P = 0.023 ) and more frequent self-monitoring of body weight ( P < 0.02 for all ) throughout the study .
-CONCLUSIONS	A low-intensity behavioral intervention in pregnancy can reduce 12-mo postpartum weight retention and improve dietary restraint and self-weighing in study completers .
-CONCLUSIONS	Future research is needed to test the long-term effects of more intensive behavioral interventions in pregnancy .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01117961 .
-
-###24760262
-OBJECTIVE	To determine basal and stimulated C-peptide percentiles in North American children and adolescents at risk for type 1 diabetes ( T1D ) and to examine factors associated with this distribution in the Diabetes Prevention Trial-Type 1 ( DPT-1 ) .
-METHODS	We included 582 subjects aged 4-18 years at randomization in the DPT-1 trials .
-METHODS	A 2-h oral glucose tolerance test ( OGTT ) was performed at baseline and every 6 months during the 5-year follow-up period .
-METHODS	The percentile values of C-peptide after baseline OGTT were estimated according to age , BMI Z score ( BMIZ ) , and/or sex categories .
-METHODS	Conditional quantile regression was used to examine the relationship between C-peptide percentiles and various independent variables .
-RESULTS	The basal and stimulated C-peptide levels increased significantly as age and BMIZ increased ( P < 0.05 ) .
-RESULTS	Both age and BMIZ had a stronger impact on the upper quartile of C-peptide distributions than the lower quartile .
-RESULTS	Sex was only significantly associated with stimulated C-peptide .
-RESULTS	Higher stimulated C-peptide levels were generally observed in girls compared with boys at the same age and BMIZ ( P < 0.05 ) .
-RESULTS	HLA type and number of positive antibodies and antibody titers ( islet cell antibody [ ICA ] , insulin autoantibody , GAD65A , and ICA512A ) were not significantly associated with C-peptide distribution after adjustment for age , BMIZ , and sex .
-CONCLUSIONS	Age - , sex - , and BMIZ-specific C-peptide percentiles can be estimated for North American children and adolescents at risk for T1D .
-CONCLUSIONS	They can be used as an assessment tool that could impact the recommendations in T1D prevention trials .
-
-###25808577
-OBJECTIVE	To investigate the effects of repeated botulinum toxin A ( BoNT-A ) injections combined with occupational therapy , including a splint , compared with occupational therapy alone on hand function in children with unilateral spastic cerebral palsy ( USCP ) , in all International Classification of Functioning , Disability and Health ( ICF ) domains .
-METHODS	This was a randomized controlled study , population-based and evaluator-blinded for primary outcome ( October 2004 to September 2010 ) .
-METHODS	Twenty children ( 14 males ; median age 3y 1mo ) with USCP , recruited at a rehabilitation centre in Sweden , were assigned to one of two parallel groups using concealed allocation .
-METHODS	In the course of one year , 10 children received occupational therapy , while 10 received repeated BoNT-A plus occupational therapy ( BoNT-A/OT ) .
-METHODS	Primary outcome ( Assisting Hand Assessment [ AHA ] ) , and secondary outcome measures ( range of movement [ ROM ] , and Canadian Occupational Performance Measure ) , were measured at baseline , 3 , 6 , 9 , and 12months .
-RESULTS	AHA revealed a superior effect in the BoNT-A/OT group at 12months : 6 out of 10 improved compared with 1 out of 10 in the occupational therapy group ( p < 0.03 ) .
-RESULTS	A 95 % Peskun exact confidence interval for the difference in proportions is given as 0.01 to 0.81 .
-RESULTS	Secondary outcomes improved in both groups .
-CONCLUSIONS	Repeated BoNT-A/OT appeared superior to occupational therapy alone for bimanual performance in young children with USCP .
-CONCLUSIONS	Active ROM and goal performance improved in both groups .
-
-###25901426
-BACKGROUND	It is unclear whether patients with early-stage Hodgkin 's lymphoma and negative findings on positron-emission tomography ( PET ) after three cycles of chemotherapy with doxorubicin , bleomycin , vinblastine , and dacarbazine ( ABVD ) require radiotherapy .
-METHODS	Patients with newly diagnosed stage IA or stage IIA Hodgkin 's lymphoma received three cycles of ABVD and then underwent PET scanning .
-METHODS	Patients with negative PET findings were randomly assigned to receive involved-field radiotherapy or no further treatment ; patients with positive PET findings received a fourth cycle of ABVD and radiotherapy .
-METHODS	This trial assessing the noninferiority of no further treatment was designed to exclude a difference in the 3-year progression-free survival rate of 7 or more percentage points from the assumed 95 % progression-free survival rate in the radiotherapy group .
-RESULTS	A total of 602 patients ( 53.3 % male ; median age , 34 years ) were recruited , and 571 patients underwent PET scanning .
-RESULTS	The PET findings were negative in 426 of these patients ( 74.6 % ) , 420 of whom were randomly assigned to a study group ( 209 to the radiotherapy group and 211 to no further therapy ) .
-RESULTS	At a median of 60 months of follow-up , there had been 8 instances of disease progression in the radiotherapy group , and 8 patients had died ( 3 with disease progression , 1 of whom died from Hodgkin 's lymphoma ) ; there had been 20 instances of disease progression in the group with no further therapy , and 4 patients had died ( 2 with disease progression and none from Hodgkin 's lymphoma ) .
-RESULTS	In the radiotherapy group , 5 of the deaths occurred in patients who received no radiotherapy .
-RESULTS	The 3-year progression-free survival rate was 94.6 % ( 95 % confidence interval [ CI ] , 91.5 to 97.7 ) in the radiotherapy group and 90.8 % ( 95 % CI , 86.9 to 94.8 ) in the group that received no further therapy , with an absolute risk difference of -3.8 percentage points ( 95 % CI , -8.8 to 1.3 ) .
-CONCLUSIONS	The results of this study did not show the noninferiority of the strategy of no further treatment after chemotherapy with regard to progression-free survival .
-CONCLUSIONS	Nevertheless , patients in this study with early-stage Hodgkin 's lymphoma and negative PET findings after three cycles of ABVD had a very good prognosis either with or without consolidation radiotherapy .
-CONCLUSIONS	( Funded by Leukaemia and Lymphoma Research and others ; RAPID ClinicalTrials.gov number , NCT00943423 . )
-
-###25167875
-OBJECTIVE	As stereotactic radiotherapy ( SRT ) becomes widespread , precise information including number , location , and margin of lesions is required when magnetic resonance ( MR ) imaging of brain metastasis is performed .
-OBJECTIVE	We compare methods using 2 separate injections and a single injection for the administration of a double dose of contrast medium for contrastenhanced MR imaging .
-METHODS	We divided 40 patients with brain metastasis into 2 groups of 20 patients .
-METHODS	Group A received 2 separate injections ( 0.2 + 0.2 mL/kg ) of contrast medium ( gadoteridol ) ; Group B received a single injection of the same total dose ( 0.4 mL/kg ) .
-METHODS	Group A underwent spin echo ( SE ) T1-weighted imaging ( T1WI ) and magnetization prepared rapid acquisition with gradient echo sequence ( MPRAGE ) after each injection , and Group B underwent the same MR studies at the same timing as Group A.
-METHODS	We evaluated the number , signal-to-noise ratio ( SNR ) , diameter , margin delineation , and volume of lesions and compared them between early and delayed studies by the 2 methods .
-RESULTS	The number of detected lesions was largest in delayed studies of MPRAGE in both groups .
-RESULTS	The SNR of the lesions was statistically lower in early studies of Group A than other studies .
-RESULTS	Delayed studies of Group B showed statistically better margin delineation than other studies on both SE-T1WI and MPRAGE studies .
-RESULTS	Diameter and enhanced volume were statistically significantly larger on delayed phase than early phase in both groups .
-CONCLUSIONS	Use of a single injection of double-dose contrast medium and longer delay time may improve margin delineation of lesions for the study of brain metastasis .
-CONCLUSIONS	Enhanced volume was larger on delayed phase , and it may influence selection of therapeutic strategy .
-
-###24637890
-BACKGROUND	Patients with sciatica frequently complain about associated back pain .
-BACKGROUND	It is not known whether there are prognostic relevant differences in Magnetic Resonance Imaging ( MRI ) findings between sciatica patients with and without disabling back pain .
-METHODS	The study population contained patients with sciatica who underwent a baseline MRI to assess eligibility for a randomized trial designed to compare the efficacy of early surgery with prolonged conservative care for sciatica .
-METHODS	Two neuroradiologists and one neurosurgeon independently evaluated all MR images .
-METHODS	The MRI readers were blinded to symptom status .
-METHODS	The MRI findings were compared between sciatica patients with and without disabling back pain .
-METHODS	The presence of disabling back pain at baseline was correlated with perceived recovery at one year .
-RESULTS	Of 379 included sciatica patients , 158 ( 42 % ) had disabling back pain .
-RESULTS	Of the patients with both sciatica and disabling back pain 68 % did reveal a herniated disc with nerve root compression on MRI , compared to 88 % of patients with predominantly sciatica ( P < 0.001 ) .
-RESULTS	The existence of disabling back pain in sciatica at baseline was negatively associated with perceived recovery at one year ( Odds ratio [ OR ] 0.32 , 95 % Confidence Interval 0.18-0 .56 , P < 0.001 ) .
-RESULTS	Sciatica patients with disabling back pain in absence of nerve root compression on MRI at baseline reported less perceived recovery at one year compared to those with predominantly sciatica and nerve root compression on MRI ( 50 % vs 91 % , P < 0.001 ) .
-CONCLUSIONS	Sciatica patients with disabling low back pain reported an unfavorable outcome at one-year follow-up compared to those with predominantly sciatica .
-CONCLUSIONS	If additionally a clear herniated disc with nerve root compression on MRI was absent , the results were even worse .
-
-###25381032
-BACKGROUND	Vitamin D deficiency is associated with cardiovascular ( CV ) risk in multiple populations , including those with chronic kidney disease ( CKD ) .
-BACKGROUND	The active form of the hormone ( 1,25 OH2D3 ) binds to receptors in multiple organs .
-BACKGROUND	CKD patients are deficient in both 25 Vitamin D and 1,25 OH2D3 .
-BACKGROUND	Clinical trial data demonstrating the benefits of vitamin D formulations are limited , and fail to show significant benefits on CV outcomes , and have compared different compounds , in various populations , and focused on a variety of outcomes .
-BACKGROUND	A understanding of the mechanism by which different vitamin D compounds confer CV protection in CKD is important for the design of future studies .
-METHODS	This 3 arm randomized prospective double-blinded placebo-controlled study examining the impact of calcitriol ( 1,25 OH2D3 ) and 25-hydroxyvitamin D3 supplementation compared to placebo on vascular stiffness , as measured by pulse wave velocity ( PWV ) .
-METHODS	Patients are enrolled from 2 tertiary care institutions if they meet inclusion criteria ( stable estimated glomerular filtration rate ( eGFR ) between 15-45ml / min , < 5ml/min change in previous 6 months ) , on stable doses of renin-angiotensin aldosterone system blockade .
-METHODS	For those already receiving vitamin D therapies , a 3 month washout period before randomization is mandatory .
-METHODS	Treatment duration is 6 months ; medications are given thrice weekly in fixed doses .
-METHODS	The primary outcome measure is Vascular stiffness , measured non-invasively by pulse wave velocity ( PWV ) .
-METHODS	Other measurements include BP , kidney function and serial blood levels of biomarkers .
-METHODS	The primary analysis will compare any vitamin D therapy versus placebo for the primary outcome defined as the change of PWV from baseline to 6 months .
-METHODS	Analysis of covariance will be used to detect differences between vitamin D preparations in the magnitude of reduction in PWV .
-CONCLUSIONS	This study is novel in that we are using a robust study design in CKD patients ( not on dialysis ) comparing placebo to different forms of vitamin D supplementation in fixed doses , irrespective of baseline values .
-CONCLUSIONS	We hope to demonstrate the biological mechanistic effect of vitamin D supplementation on vascular function in order for this information to be used in designing larger randomized controlled trials .
-BACKGROUND	Current Controlled Trials NCT01247311 .
-BACKGROUND	Date of Registration : November 12 , 2010 .
-
-###25058346
-BACKGROUND	Previous small-molecule antiangiogenics have compromised chemotherapy dose intensity in breast cancer .
-BACKGROUND	We present a phase I trial of a novel selective agent , nintedanib , plus standard chemotherapy in early breast cancer .
-METHODS	Her-2-negative breast cancer patients with tumours larger than 2cm were eligible for dose-escalation trial ( classic 3 +3 method ) .
-RESULTS	The recommended phase II dose ( RP2D ) was 150mg BID of nintedanib combined with standard dose of weekly paclitaxel followed by adriamycin plus cyclophosphamide .
-RESULTS	The dose-limiting toxicity was transaminase elevation .
-RESULTS	At the RP2D , the dose intensity was 100 % .
-RESULTS	The pathologic complete response was 50 % .
-CONCLUSIONS	The combination allows the delivery of full-dose intensity , while efficacy seems promising .
-
-###25183203
-OBJECTIVE	There is uncertainty whether cancer screening affects participant incentives for favourable lifestyle .
-OBJECTIVE	The present study investigates long-term effects of colorectal cancer ( CRC ) screening on lifestyle changes .
-METHODS	In 1999-2001 , men and women drawn from the population registry were randomised to screening for CRC by flexible sigmoidoscopy ( ` invited-to-screening ' arm ) or to no-screening ( control arm ) in the Norwegian Colorectal Cancer Prevention trial .
-METHODS	A subgroup of 3043 individuals in the ` invited-to-screening ' and 2819 in the control arm , aged 50-55years , randomised during 2001 had their lifestyle assessed by a questionnaire at inclusion and after 11years ( 42 % of cohort ) .
-METHODS	The outcome was 11-year changes in lifestyle factors ( body weight , smoking status , physical exercise , selected dietary habits ) and in total lifestyle score ( 0-4 points , translating to the number of lifestyle recommendations adhered to ) .
-METHODS	We compared outcomes in the two randomisation arms and attendees with positive versus negative findings .
-RESULTS	Total lifestyle scores improved in both arms .
-RESULTS	The improvement was smaller in the ` invited-to-screening ' arm ( score 1.43 at inclusion ; 1.58 after 11years ) compared with the control arm ( score 1.49 at inclusion ; 1.67 after 11years ) ; adjusted difference -0.05 ( 95 % CI -0.09 to -0.01 ; p = 0.03 ) .
-RESULTS	The change in the score was less favourable in screening attendees with a positive compared with negative screening result ; adjusted difference -0.16 ( 95 % CI -0.25 to -0.08 ; p < 0.001 ) .
-CONCLUSIONS	The present study suggests that possible unfavourable lifestyle changes after CRC screening are modest .
-CONCLUSIONS	Lifestyle counselling may be considered as part of cancer screening programmes .
-BACKGROUND	NCT00119912 .
-
-###25179065
-BACKGROUND	Medication-overuse headache ( MOH ) is common in the general population , and most patients are managed in primary health care .
-BACKGROUND	Brief Intervention ( BI ) has been used as a motivational technique for patients with drug and alcohol overuse , and may a have role in the treatment of MOH .
-OBJECTIVE	To explore GPs ' experiences using BI in the management of patients with MOH .
-METHODS	Qualitative study in Norwegian general practice .
-METHODS	Data were collected through four focus group interviews with 22 GPs who participated in an intervention study on BI for MOH .
-METHODS	Systematic text condensation was used to analyse transcripts from the focus group interviews .
-RESULTS	The GPs experienced challenges when trying to convince patients that the medication they used to treat and prevent headache could cause headache , but labelling MOH as a diagnosis opened up a space for change .
-RESULTS	GPs were able to use BI within the scope of a regular consultation , and they thought that the structured approach had a potential to change patients ' views about their condition and medication use .
-RESULTS	Being diagnosed with medication overuse could bring about feelings of guilt in patients , and GPs emphasised that a good alliance with the patient was necessary for successful change using BI to manage MOH .
-CONCLUSIONS	GPs experience BI as a feasible strategy to treat MOH , and the technique relies on a good alliance between the doctor and patient .
-CONCLUSIONS	When using BI , GPs must be prepared to counter patients ' misconceptions about medication used for headache .
-
-###24565345
-OBJECTIVE	Preoperative Anxiety is a negative factor in anesthetic and surgical experience .
-OBJECTIVE	Among the strategies for reducing children 's anxiety , non-pharmacological strategies are as important as the pharmacological ones , but its validity is still controversial .
-OBJECTIVE	The aim of this study was to verify if the information provided to guardians interferes with child anxiety .
-METHODS	72 children , 4-8 years old , ASA I and II , undergoing elective surgical procedures and their guardians were randomly divided into two groups : control group ( CG ) = guardian received conventional information about anesthesia ; informative group ( IG ) = guardian received an information leaflet about anesthesia .
-METHODS	Children 's anxiety was assessed using the modified Yale Preoperative Anxiety Scale ( m-YPAS ) on two occasions : at the surgical theater waiting room ( WR ) and at the operating room ( OR ) .
-METHODS	Parents ' anxiety was assessed using the Hamilton Anxiety Scale ( HAM-A ) at the CT. .
-RESULTS	There was no difference in demographic data between groups .
-RESULTS	The level of anxiety in children showed no difference between groups at two measured times .
-RESULTS	There was statistically significant difference in anxiety levels between WR and OR in both groups , p = 0.0019 for CG and p < 0.0001 for GI , as well as the prevalence of anxiety for CG ( 38.9 % WR and 69.4 % OR , p = 0.0174 ) and GI ( 19.4 % WR and 83.3 % OR , p < 0.0001 ) .
-RESULTS	The anxiety level of guardians did not differ between groups .
-CONCLUSIONS	Regardless of the quality of information provided to the guardians , the level and prevalence of anxiety in children were low at WR time and significantly increased at OR time .
-
-###25548844
-BACKGROUND	Botulinum toxin A products have been used in aesthetics for more than 20 years .
-OBJECTIVE	To compare incobotulinumtoxinA with onabotulinumtoxinA in the treatment of crow 's feet .
-METHODS	This single-center , randomized , prospective , split-face , subject - and rater-blinded study with a clinical crossover evaluation comprised 2 consecutive treatment cycles , each of 3 months ' duration separated by 6 months ( i.e. , a 9-month treatment interval ) .
-METHODS	Fourteen subjects with symmetrical crow 's feet were assessed using the Merz 5-point scale for crow 's feet , after each treatment with incobotulinumtoxinA ( right side of the face ) and onabotulinumtoxinA ( left side ) , or vice versa ( 1:1 dose conversion ratio ) .
-METHODS	The treatment applied to each side of the face was reversed in Cycle 2 .
-RESULTS	Crow 's feet severity at rest and maximum contraction was improved to a similar extent by both treatments , in both cycles and on both sides of the face .
-RESULTS	Pooled data confirmed these results .
-RESULTS	Improvements were maintained at the final visit , 3 months after treatment ( e.g. , left side at maximum contraction-onabotulinumtoxinA mean score : 2.21 [ baseline ] vs 0.93 [ 1 month ] vs 1.71 [ 3 months ] ; incobotulinumtoxinA mean score : 2.21 vs 0.86 vs 1.50 ) .
-CONCLUSIONS	IncobotulinumtoxinA and onabotulinumtoxinA ( 1:1 dose conversion ratio ) were well tolerated , showing comparable efficacy and duration of treatment effect for crow 's feet .
-
-###25145775
-BACKGROUND	Meningococcal conjugate vaccines protect individuals directly , but can also confer herd protection by interrupting carriage transmission .
-BACKGROUND	We assessed the effects of meningococcal quadrivalent glycoconjugate ( MenACWY-CRM ) or serogroup B ( 4CMenB ) vaccination on meningococcal carriage rates in 18-24-year-olds .
-METHODS	In this phase 3 , observer-blind , randomised controlled trial , university students aged 18-24 years from ten sites in England were randomly assigned ( 1:1:1 , block size of three ) to receive two doses 1 month apart of Japanese Encephalitis vaccine ( controls ) , 4CMenB , or one dose of MenACWY-CRM then placebo .
-METHODS	Participants were randomised with a validated computer-generated random allocation list .
-METHODS	Participants and outcome-assessors were masked to the treatment group .
-METHODS	Meningococci were isolated from oropharyngeal swabs collected before vaccination and at five scheduled intervals over 1 year .
-METHODS	Primary outcomes were cross-sectional carriage 1 month after each vaccine course .
-METHODS	Secondary outcomes included comparisons of carriage at any timepoint after primary analysis until study termination .
-METHODS	Reactogenicity and adverse events were monitored throughout the study .
-METHODS	Analysis was done on the modified intention-to-treat population , which included all enrolled participants who received a study vaccination and provided at least one assessable swab after baseline .
-METHODS	This trial is registered with ClinicalTrials.gov , registration number NCT01214850 .
-RESULTS	Between Sept 21 and Dec 21 , 2010 , 2954 participants were randomly assigned ( 987 assigned to control [ 984 analysed ] , 979 assigned to 4CMenB [ 974 analysed ] , 988 assigned to MenACWY-CRM [ 983 analysed ] ) ; 33 % of the 4CMenB group , 34 % of the MenACWY-CRM group , and 31 % of the control group were positive for meningococcal carriage at study entry .
-RESULTS	By 1 month , there was no significant difference in carriage between controls and 4CMenB ( odds ratio 12 , 95 % CI 08-17 ) or MenACWY-CRM ( 09 , [ 06-13 ] ) groups .
-RESULTS	From 3 months after dose two , 4CMenB vaccination resulted in significantly lower carriage of any meningococcal strain ( 182 % [ 95 % CI 34-308 ] carriage reduction ) , capsular groups BCWY ( 266 % [ 105-399 ] carriage reduction ) , capsular groups CWY ( 296 % [ 81-460 ] carriage reduction ) , and serogroups CWY ( 285 % [ 28-475 ] carriage reduction ) compared with control vaccination .
-RESULTS	Significantly lower carriage rates were also noted in the MenACWY-CRM group compared with controls : 390 % ( 95 % CI 173-550 ) carriage reduction for serogroup Y and 362 % ( 156-517 ) carriage reduction for serogroup CWY .
-RESULTS	Study vaccines were generally well tolerated , with increased rates of transient local injection pain and myalgia in the 4CMenB group .
-RESULTS	No safety concerns were identified .
-CONCLUSIONS	Although we detected no significant difference between groups at 1 month after vaccine course , MenACWY-CRM and 4CMenB vaccines reduced meningococcal carriage rates during 12 months after vaccination and therefore might affect transmission when widely implemented .
-BACKGROUND	Novartis Vaccines .
-
-###25511214
-BACKGROUND	Opioids have synergistic action with local anesthetics which may alter characteristics of epidural block .
-BACKGROUND	Giving opioids to mother before delivery of baby is still fully not accepted with some fearing risk of neonatal depression .
-OBJECTIVE	Our primary aim was to evaluate the analgesic effect of addition of 50 g fentanyl to epidural 0.5 % bupivacaine in patients undergoing elective caesarean section using visual analog scale .
-OBJECTIVE	The secondary aim was to assess onset of analgesia , volume of drug required to achieve T6 level , grade and duration of motor block and Apgar score .
-METHODS	In this prospective , randomized , double blind , placebo controlled study 64 patients scheduled for elective caesarean section under epidural anesthesia were randomly divided into two groups of 32 each .
-METHODS	The fentanyl group received 1 ml of 50 g fentanyl and the saline group received 1 ml of normal saline mixed with 10 ml of 0.5 % bupivacaine for epidural anesthesia .
-METHODS	VAS score , time to achieve T6 level , dose of bupivacaine , intraoperative analgesic consumption and duration of analgesia , grade and duration of motor block and any adverse maternal and neonatal effects were noted .
-METHODS	Data was analyzed using Students t test , chi-square test and Mann-Whitney U-test .
-METHODS	The values of P < 0.05 were considered statistically significant .
-RESULTS	Fentanyl improved the VAS score significantly ( 1.61.32 ) compared to the saline group ( 3.771.0 , P < 0.0001 ) .
-RESULTS	It also reduced the intraoperaitve analgesic supplementation compared to the saline group .
-RESULTS	( P = 0.031 ) .
-RESULTS	The postoperative duration of analgesia was prolonged in the fentanyl group ( 275.8013.61 min ) compared to the saline group ( 191.4712.16 min , P < 0.0001 ) .
-RESULTS	The other characteristics of epidural block were unaltered .
-CONCLUSIONS	Addition of 50 g fentanyl to epidural 0.5 % bupivacaine significantly reduces the VAS score .
-CONCLUSIONS	It also reduces intra-operative analgesia supplementation and prolongs the duration of postoperative analgesia without altering the other characteristics of block .
-CONCLUSIONS	The neonatal outcome is not affected with addition of fentanyl before delivery of baby .
-
-###25358214
-BACKGROUND	Transurethral resection of prostate is the gold standard operation for bladder outflow obstruction due to benign prostatic enlargement .
-BACKGROUND	However , catheter removal day is variable .
-BACKGROUND	The objective of this study was to compare early and delayed catheter removal groups in terms of length of hospital stay , weight of resected prostate , duration of resection , peri-operative blood transfusion , and postoperative complications .
-METHODS	This randomized controlled trial was carried out in Urology Unit-B , Institute of Kidney Diseases Peshawar from 1st September 2009 to 31st July 2011 .
-METHODS	Patients were selected by simple random sampling technique after taking informed consent and divided into two groups : Group A-standard catheter removal group and Group B-early catheter removal group .
-METHODS	The study excluded patients with large post-void urine volume , simultaneous internal urethrotomy and transurethral resection of prostate , co-morbidity and intra-operative complications .
-METHODS	Patients were discharged after removal of catheter if they voided successfully .
-METHODS	In Group-A the catheters were kept for more than one day according to the standard protocol of our ward .
-METHODS	The data were analysed using SPSS-17 .
-RESULTS	The study included 320 patients , 163 in Group-A and 157 in Group-B .
-RESULTS	Mean weight of resected tissue in Group-A was 46.67 9.133 grams ; it was 45.22 7.532 grams in group B. Mean catheter removal day was 4.13 1.65 days in Group-A ; and 1.23 0.933 days in Group-B .
-RESULTS	Mean length of hospital stay was 3.57 days 1.028 in Group-A and 1.29 days 1.030 in Group-B ( p-value < 0.05 ) .
-RESULTS	Length of hospital stay strongly correlated with the day of catheter removal .
-RESULTS	There was no significant difference between the two groups in terms of postoperative complications .
-CONCLUSIONS	Removal of catheter on first postoperative day after transurethral prostatectomy does not increase the postoperative complications and results in shorter hospital stay .
-
-###25831670
-OBJECTIVE	To compare the effects of intrauterine lidocaine , intrauterine lidocaine plus rectal diclofenac , and a placebo on analgesia and to determine the satisfaction of patients and surgeons in cases of endometrial biopsy .
-METHODS	The double-blind , randomised , placebo-controlled study was conducted in the Department of Obstetrics and Gynaecology of the Ondokuz Mayis University , Samsun , Turkey , from April 2013 to January 2014 , and comprised patients scheduled for in-office endometrial biopsy.They were divided into three groups : Group P , 5ml of 0.9 % saline intrauterine ; Group L , 5ml of 2 % lidocaine intrauterine ; and Group LD , 5ml of 2 % lidocaine intrauterine 10min before the procedure plus 50mg of rectal diclofenac sodium .
-METHODS	Haemodynamic changes and visual analogue scale scores were recorded during the preoperative period , when the cervix was grasped with a tenaculum , immediately after intrauterine instillation , during uterine curettage and at postoperative 10 min .
-METHODS	The patient and the surgeon were questioned about their satisfaction 15 min after the procedure .
-METHODS	SPSS 21 was used for statistical analysis .
-RESULTS	The 90 patients in the study were divided into three equal groups of 30 ( 33.33 % ) each .
-RESULTS	There were no statistically significant inter-group differences in age , bodyweight , parity , number of postmenopausal patients , haemodynamic parameters and American Society of Anesthesiologists scores ( p > 0.05 in all categories ) .
-RESULTS	In Group P , the visual analogue scale score estimated when the cervix was grasped with the tenaculum was lower when compared with Group L and Group LD ( p = 0.029 and p = 0.007 , respectively ) .
-RESULTS	At other measurement time points , the scores did not differ between the groups .
-RESULTS	The groups did not differ with respect to patient and surgeon satisfaction and complication rates ( p > 0.05 ) .
-CONCLUSIONS	Intrauterine lidocaine or intrauterine lidocaine plus rectal diclofenac application had no effect on visual analogue scale scores , patient satisfaction and vasovagal reaction .
-
-###25815570
-OBJECTIVE	To determine the effect of dantrolene premedication on various cardiovascular and biochemical variables and recovery in isoflurane-anesthetized horses .
-METHODS	6 healthy horses .
-METHODS	Each horse was anesthetized twice with a 21 - to 28-day washout period between anesthetic sessions .
-METHODS	Food was not withheld from horses before either session .
-METHODS	During each session , dantrolene ( 6 mg/kg in 2 L of water ) or water ( 2 L ) was administered via a nasogastric tube 1 hour before anesthesia was induced .
-METHODS	Anesthesia was maintained with isoflurane for 90 minutes , during which blood gas analyses and lithium-dilution cardiac output ( CO ) measurements were obtained every 10 minutes .
-METHODS	Serum creatine kinase activity was measured before and at 4 , 8 , and 12 hours after anesthesia .
-RESULTS	When horses were premedicated with dantrolene , CO at 25 , 35 , and 45 minutes after induction of anesthesia was significantly lower than that when horses were premedicated with water after which time difficulty in obtaining valid measurements suggested a continued decrease in CO ; plasma potassium concentration progressively increased during anesthesia , whereas serum creatine kinase activity remained fairly stable and within reference limits through 12 hours after anesthesia ; and 2 of 6 horses developed cardiac arrhythmias that required medical intervention .
-RESULTS	The quality of anesthetic recovery was slightly better when horses were premedicated with dantrolene versus water , although the time required for recovery did not differ significantly between treatments .
-CONCLUSIONS	Results suggested that dantrolene premedication prevented muscle damage without affecting anesthetic recovery but impaired CO and precipitated hyperkalemia and cardiac arrhythmias in healthy isoflurane-anesthetized horses .
-
-###25219686
-OBJECTIVE	Co-occurring mental and substance use disorders are associated with worse outcomes than a single disorder alone .
-OBJECTIVE	In this exploratory subgroup analysis of a randomized trial , the authors hypothesized that providing chronic care management ( CCM ) for substance dependence in a primary care setting would have a beneficial effect among persons with substance dependence and major depressive disorder or posttraumatic stress disorder ( PTSD ) .
-METHODS	Adults ( N = 563 ) with alcohol dependence , drug dependence , or both were assigned to CCM or usual primary care .
-METHODS	CCM was provided by a nurse care manager , social worker , internist , and psychiatrist .
-METHODS	Clinical outcomes ( any use of opioids or stimulants or heavy drinking and severity of depressive and anxiety symptoms ) and treatment utilization ( emergency department use and hospitalization ) were measured at three , six , and 12 months after enrollment .
-METHODS	Longitudinal regression models were used to compare randomized arms within the subgroups of participants with major depressive disorder or PTSD .
-RESULTS	Among all participants , 79 % met criteria for major depressive disorder and 36 % met criteria for PTSD at baseline .
-RESULTS	No significant effect of CCM was observed within either subgroup for any outcome , including any use of opioids or stimulants or heavy drinking , depressive symptoms , anxiety symptoms , and any hospitalizations or number of nights hospitalized .
-RESULTS	Among participants with depression , those receiving CCM had fewer days in the emergency department compared with the control group , but the finding was of only borderline significance ( p = .06 ) .
-CONCLUSIONS	Among patients with co-occurring substance dependence and mental disorders , CCM was not significantly more effective than usual care for improving clinical outcomes or treatment utilization .
-
-###26012589
-OBJECTIVE	The World Health Organization ( WHO ) has in 2013 changed the diagnostic criteria for gestational diabetes mellitus ( GDM ) to acknowledge the putative effect of mildly elevated fasting plasma glucose ( FPG ) levels on pregnancy outcomes .
-OBJECTIVE	We aimed to determine the prevalence and risk factors of GDM comparing the previous WHO 1999 criteria to the WHO 2013 criteria in North India .
-METHODS	In a population-based screening programme , 5100 randomly selected North Indian women were studied using a cross-sectional design with a questionnaire , venous FPG and 2-h capillary plasma glucose ( PG ) after a 75 g oral glucose tolerance test performed between 24 and 28 weeks of pregnancy .
-RESULTS	The prevalence of GDM was 35 % using WHO 2013 criteria vs 9 % using WHO 1999 criteria .
-RESULTS	FPG measurements identified 94 % of WHO 2013 GDM cases as opposed to 11 % of WHO 1999 GDM cases .
-RESULTS	In contrast , 2-h PG measurements identified only 13 % of WHO 2013 GDM cases compared with 96 % of the WHO 1999 GDM cases .
-RESULTS	Using logistic regression with backward elimination , urban habitat , illiteracy , non-vegetarianism , increased BMI , Hindu religion and low adult height were all independent risk factors of GDM using the 1999 criteria , whereas only urban habitat , low adult height and increased age were independent risk factors of GDM using the 2013 criteria .
-CONCLUSIONS	Intervention studies are needed to justify the WHO 2013 GDM criteria increasing the prevalence four fold to include more than one third of North Indian pregnant women .
-
-###24871705
-BACKGROUND	Methylnaltrexone bromide ( MTNX ) is a peripherally acting mu-opioid receptor antagonist , prescribed for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care .
-BACKGROUND	Studies have used this drug to determine if other opioid-induced effects besides constipation are altered by MTNX in humans and have suggested , based on their results , that these other effects are altered by peripheral opioid actions .
-OBJECTIVE	The primary objective of this report is to present results that provide indirect evidence that MTNX has centrally mediated effects , albeit slight , and secondarily to describe the effects of MTNX on psychopharmacological effects of morphine .
-METHODS	In a crossover , randomized , placebo-controlled , double-blind study , 29 healthy volunteers received 0.45 mg/kg MTNX or saline subcutaneously , followed by saline intravenously .
-METHODS	In three other conditions , 0.143 mg/kg of morphine sulfate administered intravenously was preceded by subcutaneous administration of 0 , 0.225 , or 0.45 mg/kg MTNX .
-METHODS	Before and after drug administration , subjective and physiological measures , including pupil diameter , were assessed .
-RESULTS	Two separate analyses confirmed that 0.45 mg/kg MTNX alone induced a slight degree of miosis , a centrally mediated opioid agonist effect .
-RESULTS	This dose had minimal subjective effects .
-RESULTS	MTNX at either or both the 0.225 and 0.45 mg/kg dose reduced some subjective effects of morphine without altering miosis .
-CONCLUSIONS	We present indirect evidence that MTNX crosses the blood-brain barrier in humans .
-CONCLUSIONS	Therefore , whether the reductions in subjective effects of morphine by MTNX that were observed in past studies and in this study can be attributed to peripheral mechanisms is open to question .
-
-###25175921
-BACKGROUND	The direct-acting platelet P2Y12 receptor antagonist ticagrelor can reduce the incidence of major adverse cardiovascular events when administered at hospital admission to patients with ST-segment elevation myocardial infarction ( STEMI ) .
-BACKGROUND	Whether prehospital administration of ticagrelor can improve coronary reperfusion and the clinical outcome is unknown .
-METHODS	We conducted an international , multicenter , randomized , double-blind study involving 1862 patients with ongoing STEMI of less than 6 hours ' duration , comparing prehospital ( in the ambulance ) versus in-hospital ( in the catheterization laboratory ) treatment with ticagrelor .
-METHODS	The coprimary end points were the proportion of patients who did not have a 70 % or greater resolution of ST-segment elevation before percutaneous coronary intervention ( PCI ) and the proportion of patients who did not have Thrombolysis in Myocardial Infarction flow grade 3 in the infarct-related artery at initial angiography .
-METHODS	Secondary end points included the rates of major adverse cardiovascular events and definite stent thrombosis at 30 days .
-RESULTS	The median time from randomization to angiography was 48 minutes , and the median time difference between the two treatment strategies was 31 minutes .
-RESULTS	The two coprimary end points did not differ significantly between the prehospital and in-hospital groups .
-RESULTS	The absence of ST-segment elevation resolution of 70 % or greater after PCI ( a secondary end point ) was reported for 42.5 % and 47.5 % of the patients , respectively .
-RESULTS	The rates of major adverse cardiovascular events did not differ significantly between the two study groups .
-RESULTS	The rates of definite stent thrombosis were lower in the prehospital group than in the in-hospital group ( 0 % vs. 0.8 % in the first 24 hours ; 0.2 % vs. 1.2 % at 30 days ) .
-RESULTS	Rates of major bleeding events were low and virtually identical in the two groups , regardless of the bleeding definition used .
-CONCLUSIONS	Prehospital administration of ticagrelor in patients with acute STEMI appeared to be safe but did not improve pre-PCI coronary reperfusion .
-CONCLUSIONS	( Funded by AstraZeneca ; ATLANTIC ClinicalTrials.gov number , NCT01347580 . )
-
-###24641777
-BACKGROUND	Despite being a critical survivorship care issue , there is a clear gap in current knowledge of the optimal treatment of sexual dysfunction in men with prostate cancer .
-BACKGROUND	There is sound theoretical rationale and emerging evidence that exercise may be an innovative therapy to counteract sexual dysfunction in men with prostate cancer .
-BACKGROUND	Furthermore , despite the multidimensional aetiology of sexual dysfunction , there is a paucity of research investigating the efficacy of integrated treatment models .
-BACKGROUND	Therefore , the purpose of this study is to : 1 ) examine the efficacy of exercise as a therapy to aid in the management of sexual dysfunction in men with prostate cancer ; 2 ) determine if combining exercise and brief psychosexual intervention results in more pronounced improvements in sexual health ; and 3 ) assess if any benefit of exercise and psychosexual intervention on sexual dysfunction is sustained long term .
-METHODS	A three-arm , multi-site randomised controlled trial involving 240 prostate cancer survivors will be implemented .
-METHODS	Participants will be randomised to : 1 ) ` Exercise ' intervention ; 2 ) ` Exercise + Psychosexual ' intervention ; or 3 ) ` Usual Care ' .
-METHODS	The Exercise group will receive a 6-month , group based , supervised resistance and aerobic exercise intervention .
-METHODS	The Exercise + Psychosexual group will receive the same exercise intervention plus a brief psychosexual self-management intervention that addresses psychological and sexual well-being .
-METHODS	The Usual Care group will maintain standard care for 6 months .
-METHODS	Measurements for primary and secondary endpoints will take place at baseline , 6 months ( post-intervention ) and 1 year follow-up .
-METHODS	The primary endpoint is sexual health and secondary endpoints include key factors associated with sexual health in men with prostate cancer .
-CONCLUSIONS	Sexual dysfunction is one of the most prevalent and distressing consequences of prostate cancer .
-CONCLUSIONS	Despite this , very little is known about the management of sexual dysfunction and current health care services do not adequately meet sexual health needs of survivors .
-CONCLUSIONS	This project will examine the potential role of exercise in the management of sexual dysfunction and evaluate a potential best-practice management approach by integrating pharmacological , physiological and psychological treatment modalities to address the complex and multifaceted aetiology of sexual dysfunction following cancer .
-BACKGROUND	Australian New Zealand Clinical Trials Registry ACTRN12613001179729 .
-
-###25419743
-BACKGROUND	In the context of multiple adversities , women are demonstrating resilience in rebuilding their futures , through participation in microfinance programs .
-BACKGROUND	In addition to the economic benefits of microfinance , there is evidence to suggest that it is an effective vehicle for improving health .
-METHODS	The parent study is a community-based trial to evaluate the effectiveness of a livestock microfinance intervention , Pigs for Peace ( PFP ) , on health and economic outcomes with households in 10 villages in eastern Democratic Republic of Congo .
-METHODS	The analysis for this manuscript includes only baseline data from female participants enrolled in the ongoing parent study .
-METHODS	Multiple regression analysis was used to examine if livestock/animal asset value moderates the relationship between conflict-related traumatic events and current mental health symptoms .
-RESULTS	The majority of women are 25 years or older , married , have on average 4 children in the home and have never attended school .
-RESULTS	Nearly 50 % of women report having at least one livestock/animal asset at baseline .
-RESULTS	Over the past 10 years , women report on average more than 4 ( M = 4.31 , SD 364 ) traumatic events ( range 0-18 ) .
-RESULTS	Women reported symptoms consistent with PTSD with a mean score of 2.30 ( SD = 066 range 0-4 ) and depression with a mean score of 1.86 ( SD = 049 , range 0-3 .47 ) .
-RESULTS	The livestock/animal asset value by conflict-related traumatic events interaction was significant for both the PTSD ( p = 0021 ) and depression ( p = 0002 ) symptom models .
-CONCLUSIONS	The study provides evidence of the moderating affect of livestock/animal assets on mental health symptoms for women who have experienced conflict .
-CONCLUSIONS	The findings supports evidence about the importance of livestock/animal assets to economics in rural households but expands on previous research by demonstrating the psychosocial effects of these assets on women 's health .
-BACKGROUND	clinicaltrials.gov NCT02008708 .
-
-###25040433
-BACKGROUND	Perioperative anxiety is a common and undesirable outcome in pediatric surgical patients .
-BACKGROUND	The use of interactive tools to minimize perioperative anxiety is vastly understudied .
-BACKGROUND	The main objective of the current investigation was to compare the effects of a tablet-based interactive distraction ( TBID ) tool to oral midazolam on perioperative anxiety .
-BACKGROUND	We hypothesized that the TBID tool was not inferior to midazolam to reduce perioperative anxiety .
-METHODS	108 children , ages 1-11 years , presenting for outpatient surgical procedures were prospectively randomized to oral midazolam ( 0.5 mgkg ( -1 ) ; 20 mg max ) or TBID .
-METHODS	The primary outcome was the change in anxiety level from baseline to parental separation and anesthetic induction .
-METHODS	Other data collected included emergence delirium , parental satisfaction , time-to-PACU discharge , and posthospitalization behavior .
-RESULTS	The mean difference ( 95 % CI ) in the increase of anxiety at parental separation between the TBID and the midazolam group was -9 ( -2.6 to -16.4 ) , P = 0.006 , demonstrating superiority to midazolam group ( one-sided P = 0.003 ) .
-RESULTS	For children 2-11 years , the mean difference ( 95 % CI ) in anxiety at induction was significant between the TBID and midazolam groups , -14.0 ( -6.1 to -22.0 ) , P < 0.001 .
-RESULTS	The median ( IQR ) time-to-PACU discharge was 111 ( 75-197 ) min in the midazolam group and 87 ( 55-137 ) min in the TBID group , P = 0.03 .
-RESULTS	Decreased emergence delirium and increased parental satisfaction were also observed in the TBID group .
-CONCLUSIONS	A TBID tool reduces perioperative anxiety , emergence delirium , and time-to-discharge and increases parental satisfaction when compared to midazolam in pediatric patients undergoing ambulatory surgery .
-
-###25651246
-BACKGROUND	Many patients with coronary artery disease who are not candidates for revascularization have refractory angina despite standard medical therapy .
-BACKGROUND	The balloon-expandable , stainless steel , hourglass-shaped , coronary-sinus reducing device creates a focal narrowing and increases pressure in the coronary sinus , thus redistributing blood into ischemic myocardium .
-METHODS	We randomly assigned 104 patients with Canadian Cardiovascular Society ( CCS ) class III or IV angina ( on a scale from I to IV , with higher classes indicating greater limitations on physical activity owing to angina ) and myocardial ischemia , who were not candidates for revascularization , to implantation of the device ( treatment group ) or to a sham procedure ( control group ) .
-METHODS	The primary end point was the proportion of patients with an improvement of at least two CCS angina classes at 6 months .
-RESULTS	A total of 35 % of the patients in the treatment group ( 18 of 52 patients ) , as compared with 15 % of those in the control group ( 8 of 52 ) , had an improvement of at least two CCS angina classes at 6 months ( P = 0.02 ) .
-RESULTS	The device was also associated with improvement of at least one CCS angina class in 71 % of the patients in the treatment group ( 37 of 52 patients ) , as compared with 42 % of those in the control group ( 22 of 52 ) ( P = 0.003 ) .
-RESULTS	Quality of life as assessed with the use of the Seattle Angina Questionnaire was significantly improved in the treatment group , as compared with the control group ( improvement on a 100-point scale , 17.6 vs. 7.6 points ; P = 0.03 ) .
-RESULTS	There were no significant between-group differences in improvement in exercise time or in the mean change in the wall-motion index as assessed by means of dobutamine echocardiography .
-RESULTS	At 6 months , 1 patient in the treatment group had had a myocardial infarction ; in the control group , 1 patient had died and 3 had had a myocardial infarction .
-CONCLUSIONS	In this small clinical trial , implantation of the coronary-sinus reducing device was associated with significant improvement in symptoms and quality of life in patients with refractory angina who were not candidates for revascularization .
-CONCLUSIONS	( Funded by Neovasc ; COSIRA ClinicalTrials.gov number , NCT01205893 . )
-
-###24507460
-BACKGROUND	Observational reports have linked vitamin D with chronic urticaria , yet no randomized controlled trial has been conducted .
-OBJECTIVE	To determine whether high-dose vitamin D supplementation would decrease Urticaria Symptom Severity ( USS ) scores and medication burden in patients with chronic urticaria .
-METHODS	In a prospective , double-blinded , single-center study , 42 subjects with chronic urticaria were randomized to high ( 4,000 IU/d ) or low ( 600 IU/d ) vitamin D3 supplementation for 12 weeks .
-METHODS	All subjects were provided with a standardized triple-drug therapy ( cetirizine , ranitidine , and montelukast ) and a written action plan .
-METHODS	Data on USS scores , medication use , blood for 25-hydroxyvitamin D , and safety measurements were collected .
-RESULTS	Triple-drug therapy decreased total USS scores by 33 % in the first week .
-RESULTS	There was a further significant decrease ( 40 % ) in total USS scores in the high , but not low , vitamin D3 treatment group by week 12 .
-RESULTS	Compared with low treatment , the high treatment group demonstrated a trend ( P = .052 ) toward lower total USS scores at week 12 , which was driven by significant decreases in body distribution and number of days with hives .
-RESULTS	Beneficial trends for sleep quality and pruritus scores were observed with high vitamin D3 .
-RESULTS	Serum 25-hydroxyvitamin D levels increased with high vitamin D3 supplementation , but there was no correlation between 25-hydroxyvitamin D levels and USS scores .
-RESULTS	There was no difference in allergy medication use between groups .
-RESULTS	No adverse events occurred .
-CONCLUSIONS	Add-on therapy with high-dose vitamin D3 ( 4,000 IU/d ) could be considered a safe and potentially beneficial immunomodulator in patients with chronic urticaria .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01371877 .
-
-###24966097
-BACKGROUND	This study aimed to observe the preventive potential of different hydration solutions on contrast-induced nephropathy ( CIN ) after percutaneous coronary intervention .
-METHODS	We initially screened 627 patients who were admitted to the Division of Cardiology , Beijing Anzhen Hospital between October 2010 and October 2011 .
-METHODS	The research subjects were randomly divided into four groups and were given : normal physiological saline ( PS ) , sodium bicarbonate ( SB ) , oral administration of PS + N-acetylcysteine ( NAC ) ( PS + NAC ) , or oral administration of SB + NAC ( SB + NAC ) .
-METHODS	These patients were administered a hypotonic nonionic contrast agent , and the incidence of CIN in each group was observed .
-RESULTS	The total incidence rate of CIN was 4.47 % , while the CIN incidence rates in the PS group , the SB group , the PS + NAC group and the SB + NAC group were 3.11 , 5.03 , 4.46 and 5.33 % , respectively .
-RESULTS	The differences between these groups were not statistically significant ( P = 0.238 ) , and for patients with diabetes and/or renal dysfunction , the incidence rates of CIN among the four groups did not show statistically significant differences ( P = 0.238 , 0.156 , 0.287 ) .
-CONCLUSIONS	Use of PS , SB , and NAC caused no significant reduction in the incidence of CIN , but in high-risk patients with diabetes and/or renal dysfunction , SB + NAC might be superior to the application of isotonic crystalloid solution .
-
-###25127289
-BACKGROUND	Group treatment is delivered in youth correctional facilities , yet groups may be iatrogenic .
-BACKGROUND	Few measures with demonstrated psychometric properties exist to track behaviors of individuals during groups .
-BACKGROUND	The authors assessed psychometrics for the Group Process-Individual Level measure ( GP-IL ) of group treatment .
-METHODS	N = 152 teens were randomized to 1 of 2 groups ( 10 sessions each ) .
-METHODS	Adolescents , counselors , and observers rated teen behaviors at sessions 3 and 10 .
-METHODS	GP-IL assesses reinforcement for deviancy and positive behaviors , member rejection , and counselor connection and praise .
-RESULTS	Internal consistency and 1-month stability were demonstrated .
-RESULTS	Concurrent validity is supported by correlations with measures expected to be associated with group behavior ( e.g. , coping skills ) .
-RESULTS	Counselors and observers rated more deviancy during interactive skills-building groups versus didactic psychoeducational groups ( P .005 ) .
-RESULTS	Scales evidenced incremental validity .
-CONCLUSIONS	GP-IL offers a sound method of tracking adolescent behaviors for professionals working with groups .
-CONCLUSIONS	Counselors ratings were most reliable and valid overall .
-
-###25082741
-OBJECTIVE	A-type and B-type natriuretic peptides are established markers in chronic heart failure ( HF ) .
-OBJECTIVE	C-type natriuretic peptide ( CNP ) belongs to the same peptide family , but is predominantly localized in the endothelium .
-OBJECTIVE	The prognostic role of CNP in heart failure has not been established .
-OBJECTIVE	The aim of the study was to determine the prognostic power and clinical correlates of the N-terminal part of pro CNP ( NT-proCNP ) in patients with chronic HF .
-RESULTS	In 567 hospitalized heart failure patients , NT-proCNP levels were measured at hospital discharge .
-RESULTS	The primary endpoint was a combined endpoint of all-cause mortality and HF hospitalization after 18 months .
-RESULTS	Heart failure with a preserved ejection fraction ( HFpEF ) was pre-defined as an LVEF > 40 % .
-RESULTS	Mean ( SD ) age was 71 11 years , 62 % were male , mean LVEF was 32 14 % , and 23 % had HFpEF .
-RESULTS	In multivariate linear regression , NT-proCNP levels showed a positive correlation with NT-proBNP levels and parameters of renal function , whereas a negative correlation with female sex and vascular endothelial growth factor was observed .
-RESULTS	After 18 months follow-up , 240 patients reached the combined endpoint .
-RESULTS	We observed interaction between NT-proCNP and LVEF for outcome ( P = 0.046 ) .
-RESULTS	Multivariate analyses revealed NT-proCNP to be strongly predictive for the primary endpoint [ hazard ratio ( HR ) 1.78 , 95 % confidence interval ( CI ) 1.18-2 .67 , P = 0.006 ) in patients with HFpEF , but not in patients with a reduced ejection fraction ( HFrEF ) ( HR 1.07 , 95 % CI 0.81-1 .43 , P = 0.616 ) .
-RESULTS	Finally , reclassification showed significant additive value in patients with HFpEF ( P < 0.001 ) , but not in those with HFrEF ( P = 0.453 ) .
-CONCLUSIONS	NT-proCNP is a strong independent marker for outcome in patients with HFpEF , but not in those with HFrEF .
-
-###25918277
-OBJECTIVE	Thousands of children are living with advanced cancer ; yet patient-reported outcomes ( PROs ) have rarely been used to describe their experiences .
-OBJECTIVE	We aimed to describe symptom distress in 104 children age 2 years or older with advanced cancer enrolled onto the Pediatric Quality of Life and Evaluation of Symptoms Technology ( PediQUEST ) Study ( multisite clinical trial evaluating an electronic PRO system ) .
-METHODS	Symptom data were collected using age - and respondent-adapted versions of the PediQUEST Memorial Symptom Assessment Scale ( PQ-MSAS ) at most once per week .
-METHODS	Clinical and treatment data were obtained from medical records .
-METHODS	Individual symptom scores were dichotomized into high/low distress .
-METHODS	Determinants of PQ-MSAS scores were explored using linear mixed-effects models .
-RESULTS	During 9 months of follow-up , PQ-MSAS was administered 920 times : 459 times in teens ( 99 % self-report ) , 249 times in children ages 7 to 12 years ( 96 % child/parent report ) , and 212 times in those ages 2 to 6 years ( parent reports ) .
-RESULTS	Common symptoms included pain ( 48 % ) , fatigue ( 46 % ) , drowsiness ( 39 % ) , and irritability ( 37 % ) ; most scores indicated high distress .
-RESULTS	Among the 73 PQ-MSAS surveys administered in the last 12 weeks of life , pain was highly prevalent ( 62 % ; 58 % with high distress ) .
-RESULTS	Being female , having a brain tumor , experiencing recent disease progression , and receiving moderate - or high-intensity cancer-directed therapy in the prior 10 days were associated with worse PQ-MSAS scores .
-RESULTS	In the final 12 weeks of life , receiving mild cancer-directed therapy was associated with improved psychological PQ-MSAS scores .
-CONCLUSIONS	Children with advanced cancer experience high symptom distress .
-CONCLUSIONS	Strategies to promote intensive symptom management are indicated , especially with disease progression or administration of intensive treatments .
-
-###24582053
-OBJECTIVE	To compare the tunnel enlargement of double-bundle ( DB ) anterior cruciate ligament reconstruction ( ACLR ) with and without suturing of autologous ruptured tissue to hamstring graft in patients with subacute anterior cruciate ligament injury .
-METHODS	Ten patients with subacute ( 3 months after injury ) anterior cruciate ligament rupture were randomly allocated to undergo DB ACLR with suturing of the ruptured tissue to hamstring graft ( n = 5 ) or conventional DB ACLR ( n = 5 ) .
-METHODS	When autologous ruptured tissue was used , remnant ruptured tissue was then harvested , divided into 4 pieces , placed between the loops at the distal and proximal portions of the graft , and secured with the suture .
-METHODS	As the primary endpoint , tunnel volume assessment by 3-dimensional multi-detector row computed tomography ( MDCT ) was performed 1 year after ACLR .
-METHODS	To assessthe efficacy of these procedures , the Lysholm score , anterior tibial translation ( measured with a KT-1000 arthrometer [ MEDmetric , San Diego , CA ] ) , and rotational instability ( measured by the pivot-shift test ) were evaluated after 2 years .
-RESULTS	Tunnel volume enlargement between 3 weeks and 1 year after ACLR as assessed by 3-dimensional MDCT was significantly less for ACLR using ruptured tissue than for conventional ACLR , especially at the femoral site ( P < .05 ) .
-RESULTS	However , the postoperative Lysholm score , anterior stability of the knee measured with the KT-1000 arthrometer , and rate of negative manual pivot-shift test results did not differsignificantly between the 2 groups .
-RESULTS	There was no correlation to the clinical outcomes in terms of tunnel size .
-CONCLUSIONS	The Lysholm score , anterior laxity measured with the KT-1000 arthrometer , and rotational instability according to the pivot-shift test did not differ significantly between ACLR using ruptured tissue and the conventional technique .
-CONCLUSIONS	However , ACLR using ruptured tissue produced less femoral tunnel enlargement as assessed by MDCT , warranting further long-term follow-up to elucidate its effectiveness .
-METHODS	Level II , prospective comparative study .
-
-###25809854
-BACKGROUND	Epidemiologic studies have linked high consumption of red and processed meat with risk of developing type 2 diabetes , whereas high dairy consumption has been associated with decreased risk , but interventions have been limited .
-OBJECTIVE	We compared the effects on insulin sensitivity of consuming a diet high in lean red meat with minimal dairy , a diet high in primarily low-fat dairy ( from milk , yogurt , or custard ) with no red meat , and a control diet that contained neither red meat nor dairy .
-METHODS	A randomized crossover study was undertaken with 47 overweight and obese men and women divided into 2 groups as follows : those with normal glucose tolerance and those with impaired fasting glucose or impaired glucose tolerance .
-METHODS	Participants followed the 3 weight-stable dietary interventions for 4 wk with glucose , insulin , and C-peptide measured by using oral-glucose-tolerance tests at the end of each diet .
-RESULTS	Fasting insulin was significantly higher after the dairy diet than after the red meat diet ( P < 0.01 ) with no change in fasting glucose resulting in a decrease in insulin sensitivity after the high-dairy diet ( P < 0.05 ) as assessed by homeostasis model assessment of insulin resistance ( HOMA-IR ) .
-RESULTS	A significant interaction between diet and sex was observed such that , in women alone , HOMA-IR was significantly lower after the red meat diet than after the dairy diet ( 1.33 0.8 compared with 1.71 0.8 , respectively ; P < 0.01 ) .
-RESULTS	Insulin sensitivity calculated by using the Matsuda method was 14.7 % lower in women after the dairy diet than after the red meat diet ( P < 0.01 ) with no difference between diets in men .
-RESULTS	C-peptide was not different between diets .
-CONCLUSIONS	In contrast to some epidemiologic findings , these results suggest that high consumption of dairy reduces insulin sensitivity compared with a diet high in lean red meat in overweight and obese subjects , some of whom had glucose intolerance .
-CONCLUSIONS	This trial was registered at the Australian New Zealand Clinical Trials Registry as ACTRN12613000441718 .
-
-###25487638
-BACKGROUND	The short latency stretch reflex ( SLR ) is well described , but the stimulus that evokes the SLR remains elusive .
-BACKGROUND	One hypothesis states that reflex size is proportional to muscle fiber stretch , so in this study we examined the relationship between these 2 parameters in human triceps surae muscles .
-METHODS	Achilles tendon taps and dorsiflexion stretches with different amplitudes and preactivation torques were applied to 6 participants while electromyography and muscle fascicle length changes were recorded in soleus and medial gastrocnemius ( MG ) .
-RESULTS	In response to tendon taps , neither fascicle length nor velocity changes were correlated with SLR size in either muscle , but accelerometer peaks were observed immediately after hammer-tendon contact .
-RESULTS	Similar results were obtained after dorsiflexion stretches .
-CONCLUSIONS	Muscle fascicle stretch is poorly correlated with SLR size , regardless of perturbation parameters .
-CONCLUSIONS	We attribute the SLR trigger to the transmission of vibration through the lower limb , rather than muscle fiber stretch .
-
-###25108576
-BACKGROUND	Ingestion of long-chain n-3 PUFA effectively decreases serum triacylglycerol ( TAG ) levels and increases the Omega-3 Index , defined as the % of EPA and DHA in erythrocyte fatty acids .
-BACKGROUND	However , it remains unclear whether there is a relationship between the Omega-3 Index increase ( O3I increase ) and the TAG level decrease ( TAG ) .
-BACKGROUND	We hypothesized that TAG reduction is strongly depended on Omega-3 Index increase .
-METHODS	Secondary analyses of data from a former double-blind placebo-controlled trial in which 150 dyslipidemic statin-treated subjects were randomized to four capsules of fish oil daily either as re-esterified TAG or ethyl esters in identical doses ( 1.01 g EPA +0.67 g DHA ) or corn oil as a placebo for a period of six month .
-RESULTS	108 subjects fulfilled the criteria of the current study protocol and were included in the analyses .
-RESULTS	A weak but significant negative correlation between O3I and TAG was observed ( r = -0.211 , p < 0.05 ) .
-RESULTS	However , the relation between O3I and serum TAG was not linear ( coefficients of determination R ( 2 ) : 0.044 ) .
-RESULTS	After sub-grouping the study population into Omega-3 Index response groups , the group with a mean O3I of > 4 % after six months of n-3 PUFA treatment demonstrated the greatest TAG reduction .
-CONCLUSIONS	A weak association between Omega-3 Index increase and TAG level decrease was found .
-CONCLUSIONS	This may be explained by highly fluctuating TAG levels , a large inter-individual difference in response of the Omega-3 Index , a cohort of subjects with only slightly elevated TAG levels and high Omega-3 Index values at baseline , and possibly to insufficient statistical power .
-CONCLUSIONS	Since there was no strong association between Omega-3 Index increase and the TAG level decrease , we conclude that changes in serum TAG levels are not a viable substitute for the Omega-3 Index to monitor treatment with EPA and DHA .
-
-###26444879
-OBJECTIVE	Noninvasive ventilation has been recommended to decrease mortality among immunocompromised patients with hypoxemic acute respiratory failure .
-OBJECTIVE	However , its effectiveness for this indication remains unclear .
-OBJECTIVE	To determine whether early noninvasive ventilation improved survival in immunocompromised patients with nonhypercapnic acute hypoxemic respiratory failure .
-METHODS	Multicenter randomized trial conducted among 374 critically ill immunocompromised patients , of whom 317 ( 84.7 % ) were receiving treatment for hematologic malignancies or solid tumors , at 28 intensive care units ( ICUs ) in France and Belgium between August 12 , 2013 , and January 2 , 2015 .
-METHODS	Patients were randomly assigned to early noninvasive ventilation ( n = 191 ) or oxygen therapy alone ( n = 183 ) .
-METHODS	The primary outcome was day-28 mortality .
-METHODS	Secondary outcomes were intubation , Sequential Organ Failure Assessment score on day 3 , ICU-acquired infections , duration of mechanical ventilation , and ICU length of stay .
-RESULTS	At randomization , median oxygen flow was 9 L/min ( interquartile range , 5-15 ) in the noninvasive ventilation group and 9 L/min ( interquartile range , 6-15 ) in the oxygen group .
-RESULTS	All patients in the noninvasive ventilation group received the first noninvasive ventilation session immediately after randomization .
-RESULTS	On day 28 after randomization , 46 deaths ( 24.1 % ) had occurred in the noninvasive ventilation group vs 50 ( 27.3 % ) in the oxygen group ( absolute difference , -3.2 [ 95 % CI , -12.1 to 5.6 ] ; P = .47 ) .
-RESULTS	Oxygenation failure occurred in 155 patients overall ( 41.4 % ) , 73 ( 38.2 % ) in the noninvasive ventilation group and 82 ( 44.8 % ) in the oxygen group ( absolute difference , -6.6 [ 95 % CI , -16.6 to 3.4 ] ; P = .20 ) .
-RESULTS	There were no significant differences in ICU-acquired infections , duration of mechanical ventilation , or lengths of ICU or hospital stays .
-CONCLUSIONS	Among immunocompromised patients admitted to the ICU with hypoxemic acute respiratory failure , early noninvasive ventilation compared with oxygen therapy alone did not reduce 28-day mortality .
-CONCLUSIONS	However , study power was limited .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01915719 .
-
-###24674149
-BACKGROUND	Whether the commonly used bacillus Calmette-Gurin ( BCG ) strains Connaught and Tice confer different treatment responses in non-muscle-invasive bladder cancer ( NMIBC ) is unknown .
-OBJECTIVE	To compare clinical efficacy , immunogenicity , and genetics of BCG Connaught and Tice .
-METHODS	A prospective randomized single-institution trial with treatment of 142 high-risk NMIBC patients with BCG Connaught or Tice .
-METHODS	Patients were randomized to receive six instillations of BCG Connaught or Tice .
-METHODS	For experimental studies , BCG strains were compared in C57Bl/6 mice .
-METHODS	Bladders and lymphoid tissues were analyzed by cytometry and the latter cultivated to detect live BCG .
-METHODS	BCG genomic DNA was sequenced and compared with reference genomes .
-METHODS	Recurrence-free survival was the primary end point of the clinical study .
-METHODS	The Kaplan-Meier estimator was used for estimating survival and time-to-event end points .
-METHODS	Nonparametric tests served for the analysis of the in vivo results .
-CONCLUSIONS	Treatment with BCG Connaught conferred significantly greater 5-yr recurrence-free survival compared with treatment with BCG Tice ( p = 0.0108 ) .
-CONCLUSIONS	Comparable numbers of patients experienced BCG therapy-related side effects in each treatment group ( p = 0.09 ) .
-CONCLUSIONS	In mice , BCG Connaught induced stronger T-helper cell 1-biased responses , greater priming of BCG-specific CD8 ( + ) T cells , and more robust T-cell recruitment to the bladder than BCG Tice .
-CONCLUSIONS	Genome sequencing of the BCG strains revealed candidate genes potentially involved in the differential clinical responses .
-CONCLUSIONS	BCG strain may have an impact on treatment outcome in NMIBC immunotherapy .
-RESULTS	We compared the efficacy of two commonly used bacillus Calmette-Gurin ( BCG ) strains for the treatment of NMIBC and found that treatment with BCG Connaught prevented recurrences more efficiently than BCG Tice .
-RESULTS	Comparison of the immunogenicity of the two strains in mice indicated superior immunogenicity of BCG Connaught .
-RESULTS	We also identified genetic differences that may explain the differential efficacy of the Connaught and Tice BCG strains .
-BACKGROUND	NCT00003779 .
-
-###25970050
-BACKGROUND	Early clinical trials conducted primarily in Japan have shown that TAS-102 , an oral agent that combines trifluridine and tipiracil hydrochloride , was effective in the treatment of refractory colorectal cancer .
-BACKGROUND	We conducted a phase 3 trial to further assess the efficacy and safety of TAS-102 in a global population of such patients .
-METHODS	In this double-blind study , we randomly assigned 800 patients , in a 2:1 ratio , to receive TAS-102 or placebo .
-METHODS	The primary end point was overall survival .
-RESULTS	The median overall survival improved from 5.3 months with placebo to 7.1 months with TAS-102 , and the hazard ratio for death in the TAS-102 group versus the placebo group was 0.68 ( 95 % confidence interval [ CI ] , 0.58 to 0.81 ; P < 0.001 ) .
-RESULTS	The most frequently observed clinically significant adverse events associated with TAS-102 were neutropenia , which occurred in 38 % of those treated , and leukopenia , which occurred in 21 % ; 4 % of the patients who received TAS-102 had febrile neutropenia , and one death related to TAS-102 was reported .
-RESULTS	The median time to worsening performance status ( a change in Eastern Cooperative Oncology Group performance status [ on a scale of 0 to 5 , with 0 indicating no symptoms and higher numbers indicating increasing degrees of disability ] from 0 or 1 to 2 or more ) was 5.7 months with TAS-102 versus 4.0 months with placebo ( hazard ratio , 0.66 ; 95 % CI , 0.56 to 0.78 ; P < 0.001 ) .
-CONCLUSIONS	In patients with refractory colorectal cancer , TAS-102 , as compared with placebo , was associated with a significant improvement in overall survival .
-CONCLUSIONS	( Funded by Taiho Oncology-Taiho Pharmaceutical ; RECOURSE ClinicalTrials.gov number , NCT01607957 . )
-
-###24559249
-OBJECTIVE	To assess whether standardised packs of the form introduced in Australia are associated with a reduction in acute craving and/or an increase in motivation to stop , and to replicate previous findings on perceptions of packaging , perceptions of smokers using it and perceived effects on behaviour .
-METHODS	Following abstinence of at least 12 h , 98 regular and occasional smokers were randomised to exposure to their own cigarette package , another branded package or a standardised package .
-METHODS	Craving ( QSU-brief ) , motivation to stop , both at baseline and post-exposure .
-METHODS	Ratings of 10 attributes concerning package design , perceived smoker characteristics and effects on behaviour , post-exposure only .
-RESULTS	For craving , a mixed model ANCOVA showed a significant interaction of packaging and time of measurement ( F ( 2,94 ) = 8.77 , p < .001 , partial ( 2 ) = .16 ) .
-RESULTS	There was no significant main effect or interaction for motivation to stop smoking ( p = .9 ) .
-RESULTS	The standardised pack was perceived to be significantly less appealing and less motivating to buy cigarettes , smokers using them were perceived as less popular and cigarettes from them expected to taste worse .
-CONCLUSIONS	Standardised cigarette packaging may reduce acute ( hedonic ) craving and is associated with more negative perceptions than branded packaging with less prominent health warnings .
-
-###25740742
-OBJECTIVE	Unguided nasojejunal feeding tube insertion success rates are low .
-OBJECTIVE	Controversy persists about how to safely and efficiently perform enteral nutrition ( EN ) in critically ill patients .
-OBJECTIVE	This study explores an innovative blind nasointestinal tube ( NIT ) insertion method and compares nasogastric and nasointestinal feeding .
-METHODS	Seventy critically ill patients admitted to the intensive care unit ( ICU ) were divided randomly into a nasogastric tube group ( NGT ; n = 35 ) and an NIT group ( NIT ; n = 35 ) .
-METHODS	After bedside NGT and blind-type NIT insertion , tube position was assessed and EN was started on day 1 .
-METHODS	Patients ' nutritional status parameters , mechanical ventilation duration , average ICU stay , nutritional support costs , and feeding complications were compared .
-RESULTS	Pre-albumin and transferrin levels on days 7 and 14 were significantly higher in the NIT group than in the NGT group ( p < 0.01 , p < 0.05 ) .
-RESULTS	Bloating , diarrhea , upper gastrointestinal bleeding , and liver damage did not differ significantly between groups ( p > 0.05 ) .
-RESULTS	Interleukin-6 and tumor necrosis factor - levels and APACHE II score were significantly lower in the NIT group than in the NGT group ( p < 0.01 , p < 0.05 ) .
-RESULTS	Reflux and pneumonia incidences , mechanical ventilation duration , average ICU stay length , and nutritional support costs were significantly lower in the NIT group than in the NGT group ( p < 0.01 ) .
-CONCLUSIONS	Blind bedside NIT insertion is convenient and its use can effectively improve nutritional status , reduce feeding complications , and decrease nutritional support costs of critically ill patients .
-
-###24261438
-BACKGROUND	The common cold and other viral airway infections are highly prevalent in the population , and their treatment often requires the use of medications for symptomatic relief .
-BACKGROUND	Paracetamol is as an analgesic and antipyretic ; chlorphenamine is an antihistamine ; and phenylephrine , a vasoconstrictor and decongestant .
-BACKGROUND	This randomized , double-blind , placebo-controlled trial sought to evaluate the efficacy and safety of a fixed-dose combination of paracetamol , chlorphenamine and phenylephrine in the symptomatic treatment of the common cold and flu-like syndrome in adults .
-METHODS	This study enrolled 146 individuals aged 18 to 60years who had moderate to severe flu-like syndrome or common cold .
-METHODS	After clinical examination and laboratory tests , individuals were randomly assigned to receive the fixed-dose combination ( 73 ) or placebo ( 73 ) , five capsules per day for 48 to 72hours .
-METHODS	The primary efficacy endpoint was the sum of the scores of 10 symptoms on a four-point Likert-type scale .
-METHODS	To evaluate treatment safety , the occurrence of adverse events was also measured .
-RESULTS	Mean age was 33.5 ( 9.5 ) years in the placebo group and 33.8 ( 11.5 ) in the treatment group .
-RESULTS	There were 55 women and 18 men in the placebo group , and 46 women and 27 men in the treatment group .
-RESULTS	Comparison of overall symptom scores in the two groups revealed a significantly greater reduction in the treatment group than in the placebo group ( p = 0.015 ) .
-RESULTS	Analysis at the first 13 dose intervals ( 66h of treatment ) showed a greater reduction of symptom scores in the treatment group than in the placebo group ( p < 0.05 ) .
-RESULTS	The number and distribution of adverse events were similar in both groups .
-CONCLUSIONS	A fixed-dose combination of paracetamol , chlorphenamine and phenylephrine was safe and more effective than placebo in the symptomatic treatment of the common cold or flu-like syndrome in adults .
-BACKGROUND	NCT01389518 .
-
-###25268962
-BACKGROUND	Some evidence suggests that proton pump inhibitors ( PPIs ) are an under-appreciated risk factor for hypomagnesemia .
-BACKGROUND	Whether hospitalization with hypomagnesemia is associated with use of PPIs is unknown .
-RESULTS	We conducted a population-based case-control study of multiple health care databases in Ontario , Canada , from April 2002 to March 2012 .
-RESULTS	Patients who were enrolled as cases were Ontarians aged 66 years or older hospitalized with hypomagnesemia .
-RESULTS	For each individual enrolled as a case , we identified up to four individuals as controls matched on age , sex , kidney disease , and use of various diuretic classes .
-RESULTS	Exposure to PPIs was categorized according to the most proximate prescription prior to the index date as current ( within 90 days ) , recent ( within 91 to 180 days ) , or remote ( within 181 to 365 days ) .
-RESULTS	We used conditional logistic regression to estimate the odds ratio for the association of outpatient PPI use and hospitalization with hypomagnesemia .
-RESULTS	To test the specificity of our findings we examined use of histamine H2 receptor antagonists , drugs with no causal link to hypomagnesemia .
-RESULTS	We studied 366 patients hospitalized with hypomagnesemia and 1,464 matched controls .
-RESULTS	Current PPI use was associated with a 43 % increased risk of hypomagnesemia ( adjusted odds ratio , 1.43 ; 95 % CI 1.06-1 .93 ) .
-RESULTS	In a stratified analysis , the risk was particularly increased among patients receiving diuretics , ( adjusted odds ratio , 1.73 ; 95 % CI 1.11-2 .70 ) and not significant among patients not receiving diuretics ( adjusted odds ratio , 1.25 ; 95 % CI 0.81-1 .91 ) .
-RESULTS	We estimate that one excess hospitalization with hypomagnesemia will occur among 76,591 outpatients treated with a PPI for 90 days .
-RESULTS	Hospitalization with hypomagnesemia was not associated with the use of histamine H2 receptor antagonists ( adjusted odds ratio 1.06 ; 95 % CI 0.54-2 .06 ) .
-RESULTS	Limitations of this study include a lack of access to serum magnesium levels , uncertainty regarding diagnostic coding of hypomagnesemia , and generalizability of our findings to younger patients .
-CONCLUSIONS	PPIs are associated with a small increased risk of hospitalization with hypomagnesemia among patients also receiving diuretics .
-CONCLUSIONS	Physicians should be aware of this association , particularly for patients with hypomagnesemia .
-CONCLUSIONS	Please see later in the article for the Editors ' Summary .
-
-###24915175
-OBJECTIVE	Delayed-onset muscle soreness ( DOMS ) often occurs after unaccustomed eccentric exercise and reduces exercise performance .
-OBJECTIVE	We aimed to study the preventive effects of saffron and indomethacin on the biochemical and functional indicators of DOMS after 1-session eccentric exercise .
-METHODS	A 10-day , randomized , double-blind , placebo-controlled , pretest-posttest design .
-METHODS	Controlled research laboratory .
-METHODS	Thirty-nine nonactive male university students randomly divided into saffron ( n = 12 ) , indomethacin ( n = 12 ) , and control ( n = 15 ) groups .
-METHODS	Saffron group received 1 capsule containing dried saffron powder ( n = 12 , 300 mg/d ) , indomethacin group received 75 mg indomethacin ( n = 12 , 25 mg thrice a day ) , and control group ( n = 15 ) received placebo capsules , 1 week before and 3 days after eccentric exercise .
-METHODS	Ten days before and 24 , 48 , and 72 hours after muscle soreness protocol , the maximum isometric and isotonic forces , plasma creatine kinase ( CK ) , plasma lactate dehydrogenase ( LDH ) , perceived pain , knee range of movement , and thigh circumference were measured .
-METHODS	Muscle soreness protocol was performed with a weight load equal to 80 % of the maximum isotonic force in 4 sessions with 20 repetitions and 3-minute rest in between .
-METHODS	This study shows that 10-day supplementation with 300 mg saffron significantly decreased the CK and LDH concentrations ( P < 0.0001 ) .
-METHODS	In the saffron group , there was no decline in maximum isometric and isotonic forces after eccentric exercise , but a significant decline in the isometric force was observed in the control group ( P < 0.0001 ) .
-METHODS	No pain was reported in the saffron group , whereas the indomethacin group experienced pain before 72 hours ( P < 0.001 ) .
-CONCLUSIONS	Results obtained from the current novel research indicate a strong preventive effect of 10-day supplementation with saffron on the DOMS .
-CONCLUSIONS	The saffron can be used to prevent DOMS and alleviate the DOMS symptoms .
-
-###24998677
-BACKGROUND	The evaluation of new long-lasting insecticidal bed nets ( LLINs ) is coordinated by the WHO Pesticide Evaluation Scheme ( WHOPES ) .
-BACKGROUND	In 2007 , Netprotect was granted WHOPES interim recommendation after Phase I and II evaluations .
-BACKGROUND	Present study evaluates Netprotect in a Phase III trial in rural Cambodia .
-METHODS	A randomized , prospective longitudinal study design was used to assess the performance of Netprotect over a period of three years , using conventionally-treated nets and a WHOPES recommended LLIN ( PermaNet 2.0 ) as positive controls .
-METHODS	The primary outcomes were the physical integrity , insecticide content and cone bioassay performance using .
-RESULTS	The baseline deltamethrin concentration of 43 % of Netprotect nets were below the tolerance limit while 27 % of PermaNet 2.0 nets were above the target dose limits .
-RESULTS	By 36 months Netprotect retained 35 % while PermaNet 2.0 retained 49 % of baseline insecticide dose .
-RESULTS	Moreover the proportion of the inactive deltamethrin R-alpha isomer in the Netprotect nets was 33 % at the baseline and increased to 69 % after three years while it was low and almost constant for PermaNet 2.0 ( 3-7 % ) .
-RESULTS	Only 71 % of Netprotect met the WHO criteria for bio-efficacy after three years while at least 80 % is required .
-RESULTS	Moreover Netprotect nets failed for the WHOPES criteria after 12 and 24 months .
-RESULTS	The reference LLIN met the WHOPES criteria throughout the study .
-RESULTS	Over the entire three years the reference LLIN did obtain significant higher mosquito mortality than Netprotect .
-RESULTS	The physical integrity was based on the proportionate hole index and after three years , 25 % of Netprotect and 30 % of PermaNet 2.0 were in a mediocre or poor state .
-CONCLUSIONS	Netprotect did not meet the minimum WHO criteria for bio-efficacy after 12 , 24 and 36 months .
-CONCLUSIONS	The use of a reference LLIN as positive control was helpful for data interpretation .
-CONCLUSIONS	However , for future three-year studies , it is essential that before initiating any study nets should be checked for their specifications and this for both the candidate LLIN as well as for the reference LLIN .
-CONCLUSIONS	Moreover , to improve the accuracy of the success rate of the candidate LLIN more nets should be tested for their bio-efficacy at the end of the trial .
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-###25463149
-BACKGROUND	Accreditation of healthcare organizations is a widely used method to assess and improve quality of healthcare .
-BACKGROUND	Our aim was to determine the effectiveness of improvement plans in practice accreditation of primary care practices , focusing on cardiovascular risk management ( CVRM ) .
-METHODS	A two-arm cluster randomized controlled trial with a block design was conducted with measurements at baseline and follow-up .
-METHODS	Primary care practices allocated to the intervention group ( n = 22 ) were instructed to focus improvement plans during the intervention period on CVRM , while practices in the control group ( n = 23 ) could focus on any domain except on CVRM and diabetes mellitus .
-METHODS	Primary outcomes were systolic blood pressure < 140 mmHg , LDL cholesterol < 2.5 mmol/l and prescription of antiplatelet drugs .
-METHODS	Secondary outcomes were 17 indicators of CVRM and physician 's perceived goal attainment for the chosen improvement project .
-RESULTS	No effect was found on the primary outcomes .
-RESULTS	Blood pressure targets were reached in 39.8 % of patients in the intervention and 38.7 % of patients in the control group ; cholesterol target levels were reached in 44.5 % and 49.0 % respectively ; antiplatelet drugs were prescribed in 82.7 % in both groups .
-RESULTS	Six secondary outcomes improved : smoking status , exercise control , diet control , registration of alcohol intake , measurement of waist circumference , and fasting glucose .
-RESULTS	Participants ' perceived goal attainment was high in both arms : mean scores of 7.9 and 8.2 on the 10-point scale .
-CONCLUSIONS	The focus of improvement plans on CVRM in the practice accreditation program led to some improvements of CVRM , but not on the primary outcomes .
-CONCLUSIONS	ClinicalTrials.gov NCT00791362 .
-
-###25669611
-OBJECTIVE	The purpose of the study was to compare the efficacy and adverse events of dezocine with that of fentanyl or placebo for the control of emergence agitation .
-METHODS	114 children scheduled for adenotonsillectomy under sevoflurane anesthesia were allocated randomly into 1 of the 3 groups to receive dezocine 0.1 mgxkg ( -1 ) ( group D , n = 38 ) , fentanyl 1 gkg ( -1 ) ( group F , n = 38 ) , or saline ( group S , n = 38 ) just before the end of anesthesia .
-METHODS	Emergence agitation scores were assessed .
-METHODS	Postoperative pain scores , awakening and extubation times , and the incidence of adverse effects were recorded .
-RESULTS	Emergence agitation scores , the incidence of emergence agitation and severe emergence agitation were significantly lower in groups D and F than in group S ( p = 0.021 , p = 0.018 , and p = 0.028 , respectively ) .
-RESULTS	The postoperative pain scores were lower in groups D and F as compared to group S ( p = 0.01 ) .
-RESULTS	Awakening and extubation times in groups D and F were longer than that of group S ( p = 0.001 and p = 0.000 , respectively ) .
-RESULTS	The overall incidence of postoperative complications was higher in group F compared to that in groups D and S ( p = 0.01 ) .
-CONCLUSIONS	In children undergoing adenotonsillectomy under sevoflurane anesthesia , a single IV injection of dezocine 0.1 mgxkg ( -1 ) and fentanyl 1 gkg ( -1 ) were comparable in decreasing the incidence and severity of emergence agitation .
-CONCLUSIONS	However , the use of dezocine was associated with a lower incidence of postoperative side effects .
-
-###25785968
-BACKGROUND	Crohn 's disease-related inflammation is characterized by reduced activity of the immunosuppressive cytokine transforming growth factor 1 ( TGF-1 ) due to high levels of SMAD7 , an inhibitor of TGF-1 signaling .
-BACKGROUND	Preclinical studies and a phase 1 study have shown that an oral SMAD7 antisense oligonucleotide , mongersen , targets ileal and colonic SMAD7 .
-METHODS	In a double-blind , placebo-controlled , phase 2 trial , we evaluated the efficacy of mongersen for the treatment of persons with active Crohn 's disease .
-METHODS	Patients were randomly assigned to receive 10 , 40 , or 160 mg of mongersen or placebo per day for 2 weeks .
-METHODS	The primary outcomes were clinical remission at day 15 , defined as a Crohn 's Disease Activity Index ( CDAI ) score of less than 150 , with maintenance of remission for at least 2 weeks , and the safety of mongersen treatment .
-METHODS	A secondary outcome was clinical response ( defined as a reduction of 100 points or more in the CDAI score ) at day 28 .
-RESULTS	The proportions of patients who reached the primary end point were 55 % and 65 % for the 40-mg and 160-mg mongersen groups , respectively , as compared with 10 % for the placebo group ( P < 0.001 ) .
-RESULTS	There was no significant difference in the percentage of participants reaching clinical remission between the 10-mg group ( 12 % ) and the placebo group .
-RESULTS	The rate of clinical response was significantly greater among patients receiving 10 mg ( 37 % ) , 40 mg ( 58 % ) , or 160 mg ( 72 % ) of mongersen than among those receiving placebo ( 17 % ) ( P = 0.04 , P < 0.001 , and P < 0.001 , respectively ) .
-RESULTS	Most adverse events were related to complications and symptoms of Crohn 's disease .
-CONCLUSIONS	We found that study participants with Crohn 's disease who received mongersen had significantly higher rates of remission and clinical response than those who received placebo .
-CONCLUSIONS	( Funded by Giuliani ; EudraCT number , 2011-002640-27 . )
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-###24843959
-OBJECTIVE	To compare efficacy differences between fire filiform needle combined with mild moxibustion and gabapentin combined with sham acupuncture for postherpetic neuralgia ( PHN ) .
-METHODS	One hundred cases of PHN were randomly divided into a needle group and a medicine group , 50 cases in each one .
-METHODS	In the needle group , pricking method of fire filiform needle was given at the Ashi points , and then mild moxibustion was applied for 15 min .
-METHODS	In the medicine group , the oral administration of gabapentin capsule and sham acupuncture at non-acupoints in the distal end of lesions were applied .
-METHODS	The treatment was required for 21 days in both groups .
-METHODS	The visual analogue score ( VAS ) was recorded before treatment and on the 1st day , 2nd day , 3rd day , 6th day , 9th day and 12th day of treatment .
-METHODS	The most severity of pain within last 24 h , preset severity of pain , immediate analgesia effect and starting time of pain relief were observed , also the efficacy was assessed and improvement of symptoms was observed in the follow-up visit .
-RESULTS	The total effective rate was 94.0 % ( 47/50 ) in the fire filiform needle group , which was superior to 86.0 % ( 43/50 ) in the medicine group ( P < 0.05 ) .
-RESULTS	Compared with medicine group , the VAS of the most severity of pain within last 24 h was obviously reduced after the 2nd treatment in the fire filiform needle group while that of present severity of pain was relieved after the 1st treatment ( both P < 0.05 ) .
-RESULTS	The immediate analgesia effect in the fire filiform needle group was obviously superior to that in the medicine group in the first three times of treatment ( all P < 0.05 ) .
-RESULTS	The average time of pain relief was ( 3.91 + / - 0.82 ) days in the fire filiform needle group , which was significantly earlier to ( 6.53 + / - 1.13 ) days in the medicine group ( P < 0.05 ) .
-RESULTS	26 cases were cured in the fire filiform needle group in the follow-up visit , which was superior to 2 cases in the medicine group ( P < 0.05 ) .
-RESULTS	The improvement of VAS , pain range and sleep quality in the needle group were also superior to those in the medicine group ( all P < 0.05 ) .
-RESULTS	The direct medical cost in the fire filiform needle group was ( 232.32 + / - 48.108 ) yuan , which was significantly lower than ( 466.00 + / - 41.09 ) yuan in the medicine group ( P < 0.05 ) .
-RESULTS	There was only one case of adverse effect in the medicine group during the treatment .
-CONCLUSIONS	The fire filiform needle combined with mild moxibustion could obviously relieve the pain in PHN patients , which has superior immediate analgesia effect and pain relieving time compared with gabapentin , which also has less adverse effects and cheap cost .
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-###25074046
-BACKGROUND	In this study , we evaluated the clinical relevance of serum drug levels and antidrug antibodies ( ADAbs ) with regard to response to treatment , as well as to relapse upon treatment discontinuation , in peripheral spondyloarthritis ( pSpA ) patients treated with adalimumab .
-METHODS	The study included 26 pSpA patients treated with adalimumab for either 12 weeks ( n = 12 ) or 24 weeks ( n = 14 ) in a randomized controlled trial .
-METHODS	Patients achieving inactive disease measured by Ankylosing Spondylitis Disease Activity Score ( ASDAS ) at the end of the treatment period were classified as responders .
-METHODS	Clinical characteristics , serum trough adalimumab levels and ADAbs were assessed at the end of the treatment period and at follow-up ( upon relapse or , in absence of relapse , at 16 weeks after discontinuation ) .
-RESULTS	Serum adalimumab levels measured 2 weeks after the last adalimumab administration ranged from < 0.002 to 23.0 g/ml , with a median of 11.5 g/ml .
-RESULTS	These levels were associated with neither response to treatment or disease activity measurements at the end of treatment nor with the occurrence of relapse and time to relapse after discontinuation of treatment .
-RESULTS	Antiadalimumab ADAbs were present in 23 % of the patients at end of treatment and in 35 % at follow-up after treatment discontinuation , indicating that ADAbs were masked by the presence of the drug in some patients .
-RESULTS	However , ADAbs at the end of treatment and at follow-up were not different between responders and nonresponders and were not associated with relapse upon discontinuation of treatment .
-CONCLUSIONS	There is no clear association between adalimumab serum levels or antiadalimumab ADAbs with clinical response to treatment or with relapse upon treatment discontinuation in pSpA .
-BACKGROUND	Netherlands Trial Register ID : NTR1806 ( registered 7 May 2009 ) .
-
-###25448081
-BACKGROUND	Individuals with gambling or substance-use disorders exhibit similar functional alterations in reward circuitry suggestive of a shared underlying vulnerability in addictive disorders .
-BACKGROUND	Additional research into common and unique alterations in reward-processing in substance-related and non-substance-related addictions may identify neural factors that could be targeted in treatment development for these disorders .
-METHODS	To investigate contextual reward-processing in pathological gambling , a slot-machine fMRI task was performed by three groups ( with pathological gambling , cocaine dependence and neither disorder ; N = 24 each ) to determine the extent to which two groups with addictions ( non-substance-related and substance-related ) showed similarities and differences with respect to each other and a non-addicted group during anticipatory periods and following the delivery of winning , losing and ` near-miss ' outcomes .
-RESULTS	Individuals with pathological gambling or cocaine dependence compared to those with neither disorder exhibited exaggerated anticipatory activity in mesolimbic and ventrocortical regions , with pathological-gambling participants displaying greater positive possible-reward anticipation and cocaine-dependent participants displaying more negative certain-loss anticipation .
-RESULTS	Neither clinical sample exhibited medial frontal or striatal responses that were observed following near-miss outcomes in healthy comparison participants .
-CONCLUSIONS	Alterations in anticipatory processing may be sensitive to the valence of rewards and content-disorder-specific .
-CONCLUSIONS	Common and unique findings in pathological gambling and cocaine dependence with respect to anticipatory reward and near-miss loss processing suggest shared and unique elements that might be targeted through behavioral or pharmacological interventions in the treatment of addictions .
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-###24934963
-BACKGROUND	Oral isotretinoin ( ISO ) is the gold standard for severe nodular acne .
-BACKGROUND	However , as some patients are unwilling or unable to take , or are intolerant to , ISO , other options are needed .
-OBJECTIVE	To compare efficacy and safety of oral ISO vs. doxycycline 200 mg plus adapalene 01 % / benzoyl peroxide 25 % gel ( D+A / BPO ) in severe nodular acne over 20 weeks .
-METHODS	This was a multicentre , randomized , controlled , noninferiority investigator-blinded study involving 266 subjects .
-RESULTS	D+A / BPO showed a significantly earlier onset of action in reducing nodules , papules/pustules and total lesions at week 2 .
-RESULTS	ISO was superior in reducing nodules ( 956 % vs. 887 % ) , papules/pustules ( 952 % vs. 796 % ) and total lesions ( 929 % vs. 782 % ; all P < 001 ) at week 20 .
-RESULTS	Half as many subjects for D+A / BPO compared with ISO had treatment-related , medically relevant adverse events ( 33 events in 180 % of subjects vs. 73 in 338 % of subjects , respectively ) .
-RESULTS	D+A / BPO was noninferior to ISO in the intent-to-treat population [ 95 % confidence interval ( CI ) -27 to 208 ( P = 013 ) ; 639 % vs. 549 % of subjects , respectively ] and per-protocol population [ 95 % CI 39-286 ( P = 001 ) ; 743 % vs. 58 % of subjects , respectively ) , based on the composite efficacy/safety end point .
-CONCLUSIONS	D+A / BPO showed a favourable composite efficacy/safety profile compared with ISO .
-CONCLUSIONS	This combination is an alternative to ISO in patients intolerant to , or unable or unwilling to take , oral ISO , and is an option for treatment of severe nodular acne .
-
-###25002241
-BACKGROUND	We aimed to compare the performance of novices with three-dimensional ( 3D ) versus two-dimensional ( 2D ) laparoscopy using Fundamentals of Laparoscopic Surgery ( FLS ) tasks .
-METHODS	Fifty-six novices with no uncorrected visual problems were randomly allocated to 2D and 3D groups .
-METHODS	All candidates practiced FLS tasks on a box trainer until they achieved proficiency .
-METHODS	Their performance was assessed by considering completion time , number of repetitions , and number of errors following the validated FLS proficiency criteria .
-RESULTS	Twenty-five participants in each group completed the training curriculum .
-RESULTS	The median performance time ( in minutes ) for the 3D group was 216 , which was less than that of the 2D group of 247 min ( P = 0.266 ) .
-RESULTS	The median numbers of repetitions and errors were lower for the 3D group versus the 2D group : 108 versus 121 ( P = 0.008 ) and 27 versus 105 ( P < 0.001 ) , respectively .
-CONCLUSIONS	Stereoscopic vision improved accuracy in laparoscopic skills for novices , which was manifested in reduced numbers of repetitions and errors .
-CONCLUSIONS	However , it does not affect the global performance time across all tasks .
-
-###24942646
-BACKGROUND	Pro-inflammatory cytokines including tumor necrosis factor alpha ( TNF - ) , interleukin-1 ( IL-1 ) and interleukin-6 ( IL-6 ) play an important role in the development of hematopoietic stem cell transplantation ( HSCT ) complications .
-BACKGROUND	We explored the effect of Selenium as an antioxidant and anti-inflammatory agent on pro-inflammatory cytokines levels in HSCT candidates .
-RESULTS	Plasma concentrations of TNF - , IL-1 and IL-6 were measured in 74 patients from a double-blind , randomized , placebo-controlled study .
-RESULTS	In both groups , there were 37 patients with median age of 32years .
-RESULTS	Patients received oral Se tablets ( 200 mcg ) or placebo twice daily beginning from the first day of high dose chemotherapy ( HDC ) through 14days after HSCT .
-RESULTS	Cytokine levels were determined before starting HDC ( prior to first dose of Se ) , 7 and 14days after HSCT .
-RESULTS	Plasma levels of TNF - were not significantly different between Se and control group ( P = 0.13 ) .
-RESULTS	IL-1 levels were similar between two groups ( P = 0.88 ) .
-RESULTS	No significant differences were detected in IL-6 levels between Se and control group ( P = 0.96 ) .
-CONCLUSIONS	Selenium had no effect on pro-inflammatory cytokines levels in patients undergoing HSCT .
-CONCLUSIONS	It is likely that earlier initiation and/or larger doses of Se are required to affect inflammatory cytokines significantly .
-
-###25647773
-OBJECTIVE	Sleep deprivation may be particularly detrimental to intensive care unit ( ICU ) patients .
-OBJECTIVE	Polysomnography has demonstrated abnormal sleep in medical and surgical ICU populations .
-OBJECTIVE	Both environmental factors and circadian disruption have been implicated .
-OBJECTIVE	We hypothesized that patients in a neurologic ICU would demonstrate similar sleep disturbances and that a combination of sleep-promoting interventions would increase sleep time .
-METHODS	Twelve patients were enrolled in this pilot-randomized , controlled , study in a neurologic ICU .
-METHODS	For adult patients undergoing continuous EEG for clinical purposes , noise-cancelling headphones and eye masks were worn , and an oral dose of melatonin was administered for 3 days , or until EEG was stopped .
-METHODS	Sleep was scored according to standard criteria ; EEG was characterized and analyzed quantitatively .
-RESULTS	Sixty-five percent of the patients ' recordings were unscorable based on accepted standardized criteria ; therefore , sleep measures could not be compared .
-RESULTS	For those with sleep that could be scored , total sleep time was normal , although sleep was fragmented and time spent in slow-wave or rapid eye movement sleep was notably decreased .
-RESULTS	Patients with unscorable recordings had worse injury severity measures , absent or significantly slower posterior dominant rhythm , and less coherence of posterior faster frequencies .
-RESULTS	Clinical outcomes were similar between intervention and control groups .
-CONCLUSIONS	Although sleep-promoting interventions were feasible , sleep quantification based on currently accepted criteria limited the ability to score sleep .
-CONCLUSIONS	Similar to other ICUs , sleep in the neurologic ICU is abnormal ; patients with unscorable sleep-like states have greater injury severity .
-CONCLUSIONS	This study was limited by strict enrollment criteria .
-CONCLUSIONS	A reliable method to quantify sleep and sleep-like states in the ICU is needed .
-
-###24382836
-OBJECTIVE	Ultrasound ( US ) and low-level laser therapy ( LLLT ) are commonly employed for myofascial trigger points ( MTP ) despite lack of evidence for usage as stand-alone treatments .
-OBJECTIVE	The aim of the study was to determine , on MTP of the upper trapezius muscle ( uTM ) , the effects of US and LLLT per se , as delivered in accordance with the procedures reported by surveys about their usage among physiotherapists .
-METHODS	Design was set as a double-blind , randomized , placebo-controlled study .
-METHODS	Sixty participants with at least one active MTP in uTM ( 28 women and 32 men ; mean age 24.51.44 years ) were recruited and randomly assigned to one out of five groups : active US ( n = 12 ) , placebo US ( n = 12 ) , active LLLT ( n = 11 ) , placebo LLLT ( n = 11 ) and no therapy ( control , n = 14 ) .
-METHODS	The participants and outcome assessor were blinded to the group assignment and therapy delivered .
-METHODS	Three outcome measures were assessed at baseline , after a 2-week treatment and 12weeks after the end of the intervention ( follow-up ) : pressure pain threshold , subjective pain on a numerical rating scale and muscle extensibility performing a cervical lateral flexion .
-METHODS	All subjects assigned to the intervention groups were treated five times weekly for overall 10 treatments given .
-METHODS	Two-way ANOVA was used to compare differences before and after intervention and among groups at each time-point .
-RESULTS	After the 2-week intervention , all groups showed pressure pain threshold , numerical rating scale and cervical lateral flexion significant improvements ( p < 0.05 ) , which were confirmed at the follow-up .
-RESULTS	When performing multiple comparisons , controls scored significantly less than both the active therapies and placebos , whereas no differences were detected between active therapies and placebos .
-CONCLUSIONS	Ultrasound and LLLT provided significant improvements in pain and muscle extensibility , which were superior to no therapy but not to placebos , thus raising concerns about the suitability , both economically and ethically , of administering such common physical modalities as stand-alone treatments in active MTP of the uTM .
-
-###24597469
-BACKGROUND	Integrated Treatment ( IT ) has proved effective in treating patients with Substance Use Disorders ( SUD ) co-occurring with severe Mental Disorders ( MD ) , less is known about the effectiveness of IT for patients with SUD co-occurring with less severe MD.The aim of this study was to investigate the effectiveness of IT for patients with SUD co-occurring with anxiety and/or depression on the following parameters :1 .
-BACKGROUND	The use of substances , as measured by the Alcohol Use Identification Test ( AUDIT ) , the Drug Use Identification Test ( DUDIT ) , and the Addiction Severity Index ( EuropASI ) .2 .
-BACKGROUND	The severity of psychiatric symptoms , as measured by the Symptom Check List 90 r ( SCL 90R ) .3 .
-BACKGROUND	The client 's motivation for changing his/her substance use behaviour , as measured by the Substance Abuse Treatment Scale ( SATSr ) .
-METHODS	This is a group randomized clinical trial comparing the effectiveness of IT to treatment as usual in Community Mental Health Centres ( CMHCs ) .
-METHODS	Five CMHCs were drawn to the Intervention Group ( IG ) and four CMHCs to the Control Group ( CG ) .
-METHODS	The allocation to treatment conditions was not blinded .
-METHODS	New referrals were screened with the AUDIT and the DUDIT .
-METHODS	Those who scored above the cut-off level of these instruments were assessed with the Structured Clinical Interview for DSM-IV 1 and 2 .
-METHODS	We included patients with anxiety and/or depression together with one or more SUDs .
-RESULTS	We included 55 patients in the IG and 21 in the CG .
-RESULTS	A linear multilevel model was used .
-RESULTS	Both groups reduced their alcohol and substance use during the trial , while there was no change in psychiatric symptoms in either group .
-RESULTS	However , the IG had a greater increase in motivation for substance use treatment after 12 months than had the CG with an estimate of 1.76 , p = 0.043 , CI95 % ( 0.08 ; 3.44 ) ( adjusted analyses ) .
-RESULTS	There were no adverse events .
-CONCLUSIONS	Integrated treatment is effective in increasing the motivation for treatment amongst patients with anxiety and/or depression together with SUD in outpatient clinics .
-BACKGROUND	ClinicalTrials.gov : NCT00447733 .
-
-###24512866
-BACKGROUND	Early detection of colorectal cancer ( CRC ) using fecal occult blood test ( FOBT ) reduces mortality , yet screening adherence remains low .
-OBJECTIVE	Enhancing FOBT adherence in a field experiment , using Implementation Intentions ( II ) technique .
-METHODS	Participants were randomly assigned to a standard care group or to II experimental group .
-METHODS	A test kit was mailed to 29,833 HMO-insured members in two waves in 2011 .
-METHODS	eligible persons aged 50-74 who underwent the test the year before .
-METHODS	A sample of 2200 participants was interviewed over the telephone for possible cognitive and background moderators .
-METHODS	Leaflet attached to the test kit containing an `` if-then '' condition and planning instructions of when , where , and how .
-METHODS	Test performance at 2 and 6 months following mailing of the test kit , retrieved from HMO 's computerized database ( 2011-2012 ) .
-RESULTS	Adherence in the experimental group ranged 1.2 % -6.6 % higher than in the control group .
-RESULTS	Within 6 months of kits ' mailing , test uptake for the two waves was 71.4 % and 67.9 % for experiment and control , respectively ( ( 2 ) = 40.58 , p = 0.0001 ) .
-RESULTS	The difference remained significant after controlling for age , gender , marital status , and wave ( OR = 1.17 , 95 % CI = 1.11 , 1.23 , p < 0.0001 ) .
-RESULTS	Test performance was related to cognitive and background variables .
-RESULTS	No interaction was found among cognitive or background variables and the intervention .
-CONCLUSIONS	II technique is useful in increasing adherence to CRC screening , even in a mailed form rather than a face-to-face experimental situation .
-CONCLUSIONS	Mailed II is an inexpensive and effective method , applicable for public health .
-
-###24743440
-OBJECTIVE	Because the diagnosis and treatment of carotid artery disease may reduce the rate of stroke , the aim of this study was to determine whether a diet intervention was associated with incident carotid artery disease .
-METHODS	Participants were 48 835 postmenopausal women aged 50 to 79 years who were randomly assigned to either the intervention or comparison group in the Women 's Health Initiative Diet Modification Trial .
-METHODS	Incident carotid artery disease was defined as an overnight hospitalization with either symptoms or a surgical intervention to improve flow .
-RESULTS	After a mean follow-up of 8.3 years from 1994 to 2005 , there were 297 ( 0.61 % ) incident carotid artery events .
-RESULTS	In contrast to the comparison group , the risk of incident carotid disease did not differ from those assigned to the intervention group ( hazard ratio , 1.08 ; 95 % confidence interval , 0.9-1 .4 ) .
-RESULTS	In secondary analysis , there was no significant effect of the intervention on the risk for incident carotid disease during the 5 years of postintervention follow-up from 2005 to 2010 ( hazard ratio , 1.24 ; 95 % confidence interval , 0.9-1 .7 ) and no significant effect during cumulative follow-up from 1994 to 2010 ( hazard ratio , 1.13 ; 95 % confidence interval , 0.9-1 .4 ) .
-CONCLUSIONS	Among postmenopausal women , a dietary intervention aimed at reducing total fat intake and encouraging increased intake of fruit , vegetables , and grains did not significantly change the risk for incident carotid artery disease .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00000611 .
-
-###24830741
-BACKGROUND	Novel nicotine delivery products , such as electronic cigarettes ( e-cigarettes ) , have dramatically grown in popularity despite limited data on safety and benefit .
-BACKGROUND	In contrast , the similar U.S. Food and Drug Administration ( FDA ) - approved nicotine inhaler is rarely utilized by smokers .
-BACKGROUND	Understanding this paradox could be helpful to determine the potential for e-cigarettes as an alternative to tobacco smoking .
-OBJECTIVE	To compare the e-cigarette with the nicotine inhaler in terms of perceived benefits , harms , appeal , and role in assisting with smoking cessation .
-METHODS	A cross-over trial was conducted from 2012 to 2013 PARTICIPANTS/INTERVENTIONS : Forty-one current smokers age 18 and older used the e-cigarette and nicotine inhaler each for 3 days , in random order , with a washout period in between .
-METHODS	Thirty-eight participants provided data on product use , perceptions , and experiences .
-METHODS	The Modified Cigarette Evaluation Questionnaire ( mCEQ ) measured satisfaction , reward , and aversion .
-METHODS	Subjects were also asked about each product 's helpfulness , similarity to cigarettes , acceptability , image , and effectiveness in quitting smoking .
-METHODS	Cigarette use was also recorded during the product-use periods .
-RESULTS	The e-cigarette had a higher total satisfaction score ( 13.9 vs. 6.8 [ p < 0.001 ] ; range for responses 3-21 ) and higher reward score ( 15.8 vs. 8.7 [ p < 0.001 ] ; range for responses 5-35 ) than the inhaler .
-RESULTS	The e-cigarette received higher ratings for helpfulness , acceptability , and `` coolness . ''
-RESULTS	More subjects would use the e-cigarette to make a quit attempt ( 76 % ) than the inhaler ( 24 % ) ( p < 0.001 ) .
-RESULTS	Eighteen percent ( 7/38 ) of subjects abstained from smoking during the 3-day periods using the e-cigarette vs. 10 % ( 4/38 ) using the inhaler ( p = 0.18 ) .
-CONCLUSIONS	The e-cigarette was more acceptable , provided more satisfaction , and had higher perceived benefit than the inhaler during this trial .
-CONCLUSIONS	E-cigarettes have the potential to be important nicotine delivery products owing to their high acceptance and perceived benefit , but more data are needed to evaluate their actual efficacy and safety .
-CONCLUSIONS	Providers should be aware of these issues , as patients will increasingly inquire about them .
-
-###24268723
-BACKGROUND	Open label studies have shown repetitive transcranial magnetic stimulation to be effective in reducing tics .
-OBJECTIVE	To determine whether 8 sessions of continuous theta burst stimulation ( cTBS ) over supplementary motor area ( SMA ) given over 2 days may reduce tics and motor cortical network activity in Tourette syndrome/chronic tic disorders .
-METHODS	This was a randomized ( 1:1 ) , double-blind , sham-controlled trial of functional MRI ( fMRI ) - navigated , 30 Hz cTBS at 90 % of resting motor threshold ( RMT ) over SMA in 12 patients ages 10-22 years .
-METHODS	Comorbid ADHD ( n = 8 ) , OCD ( n = 8 ) , and stable concurrent medications ( n = 9 ) were permitted .
-METHODS	Neuro-navigation utilized each individual 's event-related fMRI signal .
-METHODS	Primary clinical and cortical outcomes were : 1 ) Yale Global Tic Severity Scale ( YGTSS ) at one week ; 2 ) fMRI event-related signal in SMA and primary motor cortex ( M1 ) during a finger-tapping motor task .
-RESULTS	Baseline characteristics were not statistically different between groups ( age , current tic/OCD/ADHD severities , tic-years , number of prior medication trials , RMT ) .
-RESULTS	Mean YGTSS scores decreased in both active ( 27.5 7.4 to 23.2 9.8 ) and sham ( 26.8 4.8 to 21.7 7.7 ) groups .
-RESULTS	However , no significant difference in video-based tic severity rating was detected between the two groups .
-RESULTS	Two-day post-treatment fMRI activation during finger tapping decreased significantly in active vs. sham groups for SMA ( P = 0.02 ) , left M1 ( P = 0.0004 ) , and right M1 ( P < 0.0001 ) .
-RESULTS	No serious adverse events occurred .
-CONCLUSIONS	Active , fMRI-navigated cTBS administered in 8 sessions over 2 days to the SMA induced significant inhibition in the motor network ( SMA , bilateral M1 ) .
-CONCLUSIONS	However , both groups on average experienced tic reduction at 7 days .
-CONCLUSIONS	Larger sample size and protocol modifications may be needed to produce clinically significant tic reduction beyond placebo effect .
-
-###24500540
-BACKGROUND	Androgen deprivation therapy ( ADT ) is associated with significant bone loss and an increase in fracture risk among prostate cancer survivors ( PCS ) .
-BACKGROUND	We investigated whether impact + resistance training could stop ADT-related declines in bone mineral density ( BMD ) among PCS on ADT .
-METHODS	We randomized 51 PCS ( mean age , 70.2 yr ) currently prescribed ADT to participate in 1 yr of impact + resistance training ( Prevent Osteoporosis with Impact + Resistance ( POWIR ) ) or in an exercise placebo program of stretching exercise ( FLEX ) .
-METHODS	Outcomes were proximal femur ( total hip , femoral neck , and greater trochanter ) and spine ( L1-L4 ) BMD ( gcm ) and bone turnover markers ( serum osteocalcin ( ngmL ) and urinary deoxypyrodinoline cross-links ( nmolmmol Cr ) ) .
-RESULTS	Retention in the 1-yr study was 84 % and median attendance to supervised classes was 84 % in POWIR and 74 % in FLEX .
-RESULTS	No study-related injuries were reported .
-RESULTS	There were no significant differences between groups for average L1-L4 BMD or for BMD at any hip site .
-RESULTS	When examining individual vertebrae , POWIR has a significant effect on preservation of BMD ( -0.4 % ) at the L4 vertebrae compared with losses ( -3.1 % ) in FLEX ( P = 0.03 ) .
-CONCLUSIONS	Impact + resistance training was a safe and acceptable form of exercise for older PCS on ADT .
-CONCLUSIONS	Among our limited sample , POWIR did not appear to have a clinically meaningful effect on hip or spine BMD , but some evidence of skeletal adaptation to resistance + impact training in an androgen-deprived state was apparent .
-CONCLUSIONS	Future studies need to be conducted on a larger sample of patients and should consider modifications to POWIR that could further enhance loading across the spine and at the hip to preserve BMD at these clinically relevant sites .
-
-###26521575
-OBJECTIVE	To compare the differences in the clinical efficacy on post-stroke speech disorder between scalp electric acupuncture ( EA ) under anatomic orientation combined with rehabilitation training and simple rehabilitation training .
-METHODS	Sixty patients of post-stroke speech apraxia were randomized into an observation group and a control group , 30 cases in each one .
-METHODS	In the observation group , under anatomic orientation , the scalp EA was adopted to the dominant hemisphere Broca area on the left cerebrum .
-METHODS	Additionally , the speech rehabilitation training was combined .
-METHODS	In the control group , the speech rehabilitation training was simply , used .
-METHODS	The treatment lasted for 4 weeks totally .
-METHODS	The speech movement program module in the psychological language assessment and treatment system of Chinese aphasia was used for the evident of efficacy assessment .
-METHODS	The scores of counting , singing scale , repeating phonetic alphabet , repeating monosyllable and repeating disyllable were observed in the patients of the two groups .
-METHODS	The assessment was done separately on the day of grouping and 4 weeks after treatment .
-RESULTS	In 4 weeks of treatment , the scores of counting , singing scale , repeating phonetic alphabet , repeating monosyllable and repeating disyllable were all improved as compared with those before treatment in the two groups ( all P < 0.001 ) .
-RESULTS	The results in the observation group were better than those in the control group ( all P < 0.05 ) .
-RESULTS	The total effective rate was 100.0 % ( 30/30 ) in the observation group , superior apparently to 53.3 % ( 16/30 ) in the control group ( P < 0.001 ) .
-CONCLUSIONS	The scalp EA under anatomic orientation combined with ' speech rehabilitation training obviously improves speech apraxia in stroke patients so that the speech disorder cani be relieved .
-CONCLUSIONS	The efficacy is better than that in simple rehabilitation training .
-
-###24291456
-BACKGROUND	Effective pharmacotherapies to treat methamphetamine ( MA ) dependence have not been identified , and behavioral therapies are marginally effective .
-BACKGROUND	Based on behavioral studies demonstrating the potential efficacy of aerobic exercise for improving depressive symptoms , anxiety , cognitive deficits , and substance use outcomes , the study described here is examining exercise as a potential treatment for MA-dependent individuals .
-METHODS	This study is randomizing 150 participants with MA dependence at a residential treatment facility for addictive disorders to receive either a thrice-weekly structured aerobic and resistance exercise intervention or a health education condition .
-METHODS	Recruitment commenced in March , 2010 .
-METHODS	Enrollment and follow-up phases are ongoing , and recruitment is exceeding targeted enrollment rates .
-CONCLUSIONS	Seeking evidence for a possibly effective adjunct to traditional behavioral approaches for treatment of MA dependence , this study is assessing the ability of an 8-week aerobic and resistance exercise protocol to reduce relapse to MA use during a 12-week follow-up period after discharge from residential-based treatment .
-CONCLUSIONS	The study also is evaluating improvements in health and functional outcomes during and after the protocol .
-CONCLUSIONS	This paper describes the design and methods of the study .
-
-###24314223
-OBJECTIVE	To compare the efficacy and side effects of induction chemotherapy with vinorelbine plus cisplatin ( NP ) or docetaxel plus cisplatin ( TP ) combined with concurrent chemoradiotherapy in treating locally advanced nasopharyngeal carcinoma ( NPC ) .
-METHODS	From January 2005 to December 2009 , 146 patients with locally advanced nasopharyngeal carcinoma treated in our department were randomized into NP group ( 76 patients ) or TP group ( 70 patients ) .
-METHODS	Both groups received two cycles of induction chemotherapy and concurrent chemoradiotherapy .
-METHODS	After three weeks of induction chemotherapy , the patients received concurrent chemoradiotherapy .
-METHODS	The chemotherapy was recycled every three weeks .
-METHODS	Two groups were treated with intensity-modulated radiation therapy .
-RESULTS	The short-term efficacy of NP group was similar to that of TP group .
-RESULTS	The 3-year overall survival rates , disease-free-survival rates , locoregional relapse-free survival rates and distant metastasis-free survival rates in the NP and TP groups were 84.2 % and 82.9 % , 71.1 % and 74.3 % , 89.5 % and 91.4 % , 81.6 % and 77.1 % , respectively ( P > 0.05 ) .
-RESULTS	The occurrence rates of leucopenia , anemia and acute mucositis were significantly higher in the TP group than those in the NP group ( P < 0.05 ) .
-RESULTS	The gastrointestinal toxicity , dermatitis and liver toxicity were similar in the two groups .
-CONCLUSIONS	The efficacy of NP regimen induction chemotherapy plus concurrent chemordiotherapy for advanced NPC is similar to that of TP regimen .
-CONCLUSIONS	The toxicity of the NP regimen is lower than that of NP regimen , tolerable , and with a good compliance .
-
-###24261913
-BACKGROUND	Depressive disorders occur in 2 to 5 % of the adolescents and are associated with a high burden of disease , a high risk of recurrence and a heightened risk for development of other problems , like suicide attempts .
-BACKGROUND	The effectiveness of cognitive behaviour therapy ( CBT ) , cost-effectiveness of this treatment and the costs of illness of clinical depression in adolescents are still unclear .
-BACKGROUND	Although several Randomized Controlled Trials ( RCT ) have been conducted to establish the efficacy of CBT , the effectiveness has not been established yet .
-BACKGROUND	Aim of this study is to conduct a RCT to test the effectiveness of CBT and to establish the cost-effectiveness of CBT under rigorous conditions within routine care provided by professionals already working in mental health institutions .
-METHODS	CBT is investigated with a multi-site , RCT using block randomisation .
-METHODS	The targeted population is 140 clinically referred depressed adolescents aged 12 to 21years old .
-METHODS	Adolescents are randomly assigned to the experimental ( N = 70 , CBT ) or control condition ( N = 70 , TAU ) .
-METHODS	Four assessments ( pre , post , follow up at 6 and 12months ) and two mediator assessments during treatment are conducted .
-METHODS	Primary outcome measure is depression diagnosis based on a semi-structured interview namely the K-SADS-PL .
-METHODS	Secondary outcome measures include depressive symptoms , severity and improvement of the depression , global functioning , quality of life , suicide risk , comorbidity , alcohol and drug use , parental depression and psychopathology , parenting and conflicts .
-METHODS	Costs and treatment characteristics will also be assessed .
-METHODS	Furthermore , moderator and mediator analyses will be conducted .
-CONCLUSIONS	This trial will be the first to compare CBT with TAU under rigorous conditions within routine care and with a complex sample .
-CONCLUSIONS	Furthermore , cost-effectiveness of treatment and cost-of-illness of clinical depression are established which will provide new insights on depression as a disorder and its treatment .
-BACKGROUND	Dutch Trial register number NTR2676 .
-BACKGROUND	The study was financially supported by a grant from ZonMw , the Netherlands organization for health research and development , grant number 157004005 .
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-###25518015
-OBJECTIVE	Video laparoscopic bariatric surgery is the preferred surgical technique for treating morbid obesity .
-OBJECTIVE	However , pneumoperitoneum can pose risks to the kidneys by causing a decrease in renal blood flow .
-OBJECTIVE	Furthermore , as in other surgical procedures , laparoscopic bariatric surgery triggers an acute inflammatory response .
-OBJECTIVE	Neutrophil gelatinase-associated lipocalin is an early and accurate biomarker of renal injury , as well as of the inflammatory response .
-OBJECTIVE	Anesthetic drugs could offer some protection for the kidneys and could attenuate the acute inflammatory response from surgical trauma .
-OBJECTIVE	The objective of this study was to compare the effects of two types of anesthetics , propofol and sevoflurane , on the serum levels of neutrophil gelatinase-associated lipocalin during the perioperative period in laparoscopic bariatric surgery .
-METHODS	Sixty-four patients scheduled for laparoscopic bariatric surgery were randomized into two anesthesia groups and were administered either total intravenous anesthesia ( propofol ) or inhalation anesthesia ( sevoflurane ) .
-METHODS	In the perioperative period , blood samples were collected at three time points ( before anesthesia , 6 hours after pneumoperitoneum and 24 hours after pneumoperitoneum ) and urine output was measured for 24 hours .
-METHODS	Acute kidney injuries were evaluated by examining both the clinical and laboratory parameters during the postoperative period .
-METHODS	The differences between the groups were compared using non-parametric tests .
-METHODS	ReBEC ( http://www.ensaiosclinicos.gov.br/rg/recruiting/ ) : RBR-8wt2fy
-RESULTS	None of the patients developed an acute kidney injury during the study and no significant differences were found between the serum neutrophil gelatinase-associated lipocalin levels of the groups during the perioperative period .
-CONCLUSIONS	The choice of anesthetic drug , either propofol or sevoflurane , did not affect the serum levels of neutrophil gelatinase-associated lipocalin during the perioperative period in laparoscopic bariatric surgery .
-
-###25327311
-OBJECTIVE	To compare postprandial efficacy in type 2 diabetic patients given mitiglinide and sitagliptin , both of which are known to improve postprandial hyperglycemia , by using continuous glucose monitoring ( CGM ) .
-METHODS	Eleven patients with type 2 diabetes were given mitiglinide 10 mg three times a daily or sitagliptin 50 mg once a day for 1 month and were hospitalized for 4 days and evaluated by CGM .
-METHODS	On discharge , they were crossed over to the other regimen for 1 month of treatment/4 days of evaluation .
-METHODS	The CGM data were used to compare each parameter for glycemic variability .
-RESULTS	The patients were 60 10 ( mean SD ) years old , and had HbA1c value 7.3 0.9 % .
-RESULTS	The pre-meal glucose levels before lunch were significantly lower with mitiglinide than with sitagliptin ( 116 26/131 34 mg/dl , p = 0.022 ) .
-RESULTS	The AUC measuring over 140 mg/dl 3 h after breakfast ( mitiglinide 4812 4219/sitagliptin 7807 6391 mg/dlmin , p = 0.042 ) and lunch ( mitiglinide 5658 5856/sitagliptin 8492 7161 , p = 0.050 ) was significantly lower with mitiglinide than with sitagliptin .
-CONCLUSIONS	A CGM-based comparison showed that mitiglinide and sitagliptin were different in their glucose-lowering effects , where mitiglinide significantly improved hyperglycemia after breakfast and lunch , and significantly lowered pre-meal glucose levels before lunch , compared to sitagliptin .
-
-###24595864
-OBJECTIVE	To test recommended implantable cardioverter defibrillator ( ICD ) follow-up methods by ` in-person evaluations ' ( IPE ) vs. ` remote Home Monitoring ' ( HM ) .
-RESULTS	ICD patients were randomized 2:1 to automatic HM or to Conventional monitoring , with follow-up checks scheduled at 3 , 6 , 9 , 12 , and 15 months post-implant .
-RESULTS	Conventional patients were evaluated with IPE only .
-RESULTS	Home Monitoring patients were assessed remotely only for 1 year between 3 and 15 month evaluations .
-RESULTS	Adherence to follow-up was measured .
-RESULTS	HM and Conventional patients were similar ( age 63 years , 72 % male , left ventricular ejection fraction 29 % , primary prevention 73 % , DDD 57 % ) .
-RESULTS	Conventional management suffered greater patient attrition during the trial ( 20.1 vs. 14.2 % in HM , P = 0.007 ) .
-RESULTS	Three month follow-up occurred in 84 % in both groups .
-RESULTS	There was 100 % adherence ( 5 of 5 checks ) in 47.3 % Conventional vs. 59.7 % HM ( P < 0.001 ) .
-RESULTS	Between 3 and 15 months , HM exhibited superior ( 2.2 ) adherence to scheduled follow-up [ incidence of failed follow up was 146 of 2421 ( 6.0 % ) in HM vs. 145 of 1098 ( 13.2 % ) in Conventional , P < 0.001 ] and punctuality .
-RESULTS	In HM ( daily transmission success rate median 91 % ) , transmission loss caused only 22 of 2275 ( 0.97 % ) failed HM evaluations between 3 and 15 months ; others resulted from clinic oversight .
-RESULTS	Overall IPE failure rate in Conventional [ 193 of 1841 ( 10.5 % ) exceeded that in HM [ 97 of 1484 ( 6.5 % ) , P < 0.001 ] by 62 % , i.e. HM patients remained more loyal to IPE when this was mandated .
-CONCLUSIONS	Automatic remote monitoring better preserves patient retention and adherence to scheduled follow-up compared with IPE .
-BACKGROUND	NCT00336284 .
-
-###25261801
-OBJECTIVE	After the advent of the GreenLight XPS ( 180 W ) 532 nm laser , photoselective vapo-enucleation of the prostate could compete with holmium laser enucleation of the prostate as a size independent procedure .
-OBJECTIVE	We assessed whether photoselective vapo-enucleation of the prostate-XPS is not less effective than holmium laser enucleation of prostate for improvement of lower urinary tract symptoms secondary to benign prostatic hyperplasia .
-METHODS	A randomized controlled noninferiority trial comparing holmium laser enucleation of the prostate to photoselective vapo-enucleation of the prostate-XPS 180 W was conducted .
-METHODS	I-PSS , flow rate , residual urine , prostate specific antigen and prostate volume changes as well as perioperative and late adverse events were compared .
-METHODS	Noninferiority of I-PSS at 1 year was evaluated using a 1-sided test at 5 % level of significance .
-METHODS	The statistical significance of other comparators was assessed at the ( 2-sided ) 5 % level .
-RESULTS	Overall 50 and 53 patients were included in the holmium laser enucleation and photoselective vapo-enucleation of the prostate groups , respectively .
-RESULTS	Operative time , hospital stay and time to catheter removal were comparable between the groups .
-RESULTS	There was significant , comparable improvement in I-PSS and post-void residual urine volume at 1 , 4 and 12 months .
-RESULTS	After 4 months prostate size reduction was significantly higher in the holmium laser enucleation of prostate group ( 74.3 % vs 43.1 % , p = 0.001 ) .
-RESULTS	At 12 months maximum urine flow rate was significantly higher in the holmium laser enucleation of prostate group ( 26.4 11.5 vs 18.4 7.5 ml per second , p = 0.03 ) .
-RESULTS	Re-intervention was needed in 2 and 3 cases in the holmium laser enucleation and photoselective vapo-enucleation of the prostate groups , respectively ( p = 1.0 ) .
-RESULTS	Mean estimated cost per holmium laser enucleation of prostate procedure was significantly lower than per photoselective vapo-enucleation of the prostate procedure .
-CONCLUSIONS	Compared to holmium laser enucleation of prostate , GreenLight XPS laser photoselective vapo-enucleation of the prostate is safe , noninferior and effective in treatment of benign prostatic hyperplasia .
-
-###24895288
-BACKGROUND	The rate of hyponatremia is higher in hospitalized cancer patients than in hospitalized patients without cancer and is associated with poor clinical outcomes .
-BACKGROUND	The availability of V2 receptor antagonists has been a major breakthrough in the management of hyponatremia , but its efficacy and safety in treating hyponatremia in patients with cancer is not known .
-METHODS	Adult patients with cancer who were admitted to The University of Texas MD Anderson Cancer Center with nonhypovolemic hyponatremia ( 125-130 mmol/L ) were randomized to receive either tolvaptan or placebo in a double-blind , placebo-controlled , adaptive , randomized trial .
-METHODS	Both groups received the standard of care for hyponatremia , except that patients were allowed to drink to thirst .
-RESULTS	A preplanned Data Safety Monitoring Board analysis of 30 of 48 randomized patients who completed the study revealed that the primary endpoint of hyponatremia correction was met by 16 of 17 patients who received tolvaptan and by 1 of 13 patients who received placebo ( 94 % vs 8 % ; P < .001 ) , which met the study stopping rule for superiority .
-RESULTS	The secondary endpoints between the tolvaptan and placebo groups ( meanstandard deviation ) for length of stay ( 2115 days vs 2615 days , respectively ) and change in the Mini-Mental State Examination score ( -0.351.66 vs 0.312.42 , respectively ) were not significantly different .
-RESULTS	No overcorrection of serum sodium ( > 12 mmol/L per day ) was noted in the tolvaptan group , and the main adverse events noted were dry mouth , polydipsia , and polyuria , leading to 13 % study withdrawal .
-CONCLUSIONS	Although tolvaptan was effective for correcting hyponatremia in patients with cancer , studies with a larger sample size will be required to confirm the current findings , including the outcomes of secondary endpoints .
-
-###24783622
-BACKGROUND	Remifentanil is a powerful analgesic with fast onset and ultra-short duration of action .
-BACKGROUND	Its context-sensitive half-time is consistently short even after a prolonged infusion .
-BACKGROUND	Remifentanil is effective for providing better postoperative analgesia , but this method is not generally accepted in Japan .
-BACKGROUND	The present study was conducted to document efficacy and safety of low-dose remifentanil infusion in postoperative patients .
-METHODS	Forty patients undergoing abdominal surgery were studied prospectively .
-METHODS	They were randomly assigned to either remifentanil ( 0.02 microg x kg ( -1 ) x min ( -1 ) ) or placebo group .
-METHODS	Postoperatively all patients received continuous epidural anesthesia with lidocaine and IV patient-controlled analgesia with fentanyl .
-METHODS	Flurbiprofen was administered only when no pain relief was achieved .
-METHODS	Visual analogue scale ( VAS ) , requirement of fentanyl and flurbiprofen , and the incidence of remifentanil-related adverse effects ( respiratory depression , nausea , vomiting , pruritus ) were examined at 3 hourly intervals for 12 hours .
-RESULTS	There are no statistical differences between two groups in pain scores .
-RESULTS	No adverse events including respiratory depression occurred throughout the study in both groups .
-CONCLUSIONS	Remifentanil infusion at 0.02 microg x kg ( -1 ) x min ( -1 ) can safely be used without any serious adverse events , while it may not be enough for postoperative analgesia .
-CONCLUSIONS	The best dosage of this drug for postoperative analgesia remains to be elucidated .
-
-###25252510
-OBJECTIVE	To assess the effect of Eutectic Mixture of Local Anaesthetics cream and rattle on soothing the vaccination pain on four-month-infants .
-METHODS	The single blind randomised clinical trial was conducted from May 2012 to February 2013 at a clinic under the Gonabad University of Medical Sciences , Iran , and comprised four-month infants who were selected randomly and divided into three groups .
-METHODS	In one group , 2g of eutectic mixture of local anaesthetics cream was rubbed on the injection spot before administration ; for the other group , the rattle was shaken from 30s to 15s before injection .
-METHODS	The last group consisted of controls .
-METHODS	The infants were filmed after vaccination .
-METHODS	Afterward , a pain questionnaire was filled out by a trained observer .
-METHODS	SPSS 11.5 was used for statistical analysis .
-RESULTS	Of the 50 subjects in the study 16 ( 32 % ) each were in the cream and rattle groups , while the rest ( 36 % ) were in the control group .
-RESULTS	The severity of the pain before intervention in the control , cream and rattle groups was 2.22 + / - 0.88 , 2.12 + / - 0.95 and 2.25 + / - 1.06 respectively , which were not statistically significant ( p < 0.93 ) .
-RESULTS	Likewise , the mean severity of pain at the moment of intervention in the three above groups were 8.67 + / - 0.77 , 7.12 + / - 0.5 and 7.87 + / - 0.96 respectively , which was significantly different ( p < 0.001 ) .
-RESULTS	The severity of pain 15seconds after the intervention in the groups was 5.06 + / - 1.51 , 4.87 + / - 1.31 and 4.19 + / - 1.94 respectively , which were not statistically different ( p < 0.27 ) .
-CONCLUSIONS	The eutectic mixture of local anaesthetics cream and shaking rattle were effective in attenuating pain of vaccination among the infants , but the latter was not as significant as the former .
-
-###24534142
-BACKGROUND	Oral budesonide 9 mg/day represents first-line treatment of mild-to-moderately active ileocolonic Crohn 's disease .
-BACKGROUND	However , there is no precise recommendation for budesonide dosing due to lack of comparative data .
-BACKGROUND	A once-daily ( OD ) 9 mg dose may improve adherence and thereby efficacy .
-METHODS	An eight-week , double-blind , double-dummy randomised trial compared budesonide 9 mg OD versus 3mg three-times daily ( TID ) in patients with mild-to-moderately active ileocolonic Crohn 's disease .
-METHODS	Primary endpoint was clinical remission defined as CDAI < 150 at week 8 ( last observation carried forward ) .
-RESULTS	The final intent-to-treat population comprised 471 patients ( 238 [ 9 mg OD ] , 233 [ 3 mg TID ] ) .
-RESULTS	The confirmatory population for the primary endpoint analysis was the interim per protocol population ( n = 377 ; 188 [ 9 mg OD ] , 189 [ 3mg TID ] ) , in which the primary endpoint was statistically non-inferior with budesonide 9 mg OD versus 3 mg TID .
-RESULTS	Clinical remission was achieved in 71.3 % versus 75.1 % , a difference of -3.9 % ( 95 % CI [ -14.6 % ; 6.4 % ] ; p = 0.020 for non-inferiority ) .
-RESULTS	The mean ( SD ) time to remission was 21.9 ( 13.8 ) days versus 21.4 ( 14.6 ) days with budesonide 9 mg OD versus 3 mg TID , respectively .
-RESULTS	In a subpopulation of 122 patients with baseline SES-CD ulcer score 1 , complete mucosal healing occurred in 32.8 % ( 21/64 ) on 9 mg OD and 41.4 % ( 24/58 ) on 3mg TID ; deep remission ( mucosal healing and clinical remission ) was observed in 26.6 % ( 17/64 ) and 32.8 % ( 19/58 ) of patients , respectively .
-RESULTS	Treatment-emergent suspected adverse drug reactions were reported in 4.6 % of 9 mg OD and 4.7 % of 3 mg TID patients .
-CONCLUSIONS	Budesonide at the recommended dose of 9 mg/day can be administered OD without impaired efficacy and safety compared to 3mg TID dosing in mild-to-moderately active Crohn 's disease .
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-###24491070
-OBJECTIVE	Recent data have supported the use of an early exposure intervention to promote a reduction in acute stress and posttraumatic stress disorder ( PTSD ) symptoms after trauma exposure .
-OBJECTIVE	The present study explored a comprehensive predictive model that included history of trauma exposure , dissociation at the time of the trauma and early intervention , and physiological responses ( cortisol and heart rate ) to determine which variables were most indicative of reduced PTSD symptoms for an early intervention or treatment as usual .
-METHODS	Participants ( n = 137 ) were randomly assigned to the early intervention condition ( n = 68 ) or assessment-only condition ( n = 69 ) while receiving care at the emergency department of a Level 1 trauma center .
-METHODS	Follow-up assessments occurred at 4 and 12 weeks posttrauma .
-RESULTS	Findings suggested that dissociation at the time of the 1st treatment session was associated with reduced response to the early intervention .
-RESULTS	No other predictors were associated with treatment response .
-RESULTS	For treatment as usual , cortisol levels at the time of acute care and dissociation at the time of the traumatic event were positively associated with PTSD symptoms .
-CONCLUSIONS	Dissociation at the time at which treatment starts may indicate poorer response to early intervention for PTSD .
-CONCLUSIONS	Similarly , dissociation at the time of the event was positively related to PTSD symptoms in those who received treatment as usual .
-
-###24560392
-BACKGROUND	The arterial blood gas measurement process is a painful and invasive procedure , often uncomfortable for both the patient and the physician .
-BACKGROUND	Because the patient-related factors that determine the difficulty of the process can not be controlled , the physician-related factors and blood gas measurement techniques are a modifiable area of improvement that ought to be considered .
-BACKGROUND	Many hospitals use insulin syringes or syringes washed with heparin for the purpose of blood gas measurement because they do not have blood gas-specific syringes .
-BACKGROUND	In this prospective cross-sectional study , we aimed to compare safety-engineered blood gas syringes and conventional heparinized syringes used during the arterial blood gas extraction process in terms of ease of operation , the physician-patient satisfaction , laboratory appropriateness , and complications .
-METHODS	Our study included patients whose arterial blood gas needed to be measured in the emergency department and who agreed to participate in the study .
-METHODS	Patients were randomly divided into 2 groups .
-METHODS	The arterial blood gas of the patients from the first group was measured by using conventional heparinized syringes , whereas safety-engineered blood gas syringes were used to measure the arterial blood gas of the patients from the second group .
-METHODS	The groups were compared in terms of demographic data , the number of attempts , the physician and patient satisfaction , early and late-term complications , and laboratory appropriateness of the taken sample .
-RESULTS	A total of 550 patients were included in our study in a 2-month study period .
-RESULTS	There were no significant differences between patients in terms of sex , age , weight , height , body mass index , and wrist circumference .
-RESULTS	In addition , the number of attempts ( P = .489 ) , patients ' pain level during the procedure ( P = .145 ) , and the degree of difficulty of the procedure according to the patient ( P = .109 ) and physician ( P = .554 ) were not significantly different between the groups .
-RESULTS	After arterial blood gas extraction procedure , 115 patients ( 20.9 % ) developed complications .
-RESULTS	In the conventional heparinized syringe group , the complication rate ( n = 69 ; 25.1 % ) was significantly higher compared with the group that used safety-engineered blood gas syringes ( n = 46 ; 16 % ; P = .0211 ) .
-RESULTS	Localized pain , which is one of the most common early complications , was more frequent in the conventional heparinized syringe group ( 19.3 % ) .
-RESULTS	Complications in women ( P = .003 ) and local pain ( P = .01 ) developed lesser in the second group that used safety-engineered blood gas syringes , and the patient-physician satisfaction was higher in that group , as well .
-RESULTS	In the evaluation 48 hours after the procedure , the ratios of infection and local hematoma were higher in the conventional heparinized syringe group ( P = .0213 and P < .0001 ) .
-CONCLUSIONS	In this study , we did not find any significant differences between the conventional heparinized syringes and safety-engineered blood gas syringes in terms of ease of operation , physician and patient satisfaction , and appropriateness of the taken sample .
-CONCLUSIONS	However , patients whose arterial blood gas was extracted by using safety-engineered blood gas syringes felt less pain and experienced fewer infections and hematomas at their puncture site .
-
-###24403477
-BACKGROUND	Transmembrane tumor necrosis factor ( TNF ) - , found on monocytes , is a body 's key defense against cancer .
-BACKGROUND	In patients with type 2 diabetes mellitus ( DM ) and metabolic syndrome , immunity is suppressed , resulting in a high risk of several inflammatory disorders and cancer .
-METHODS	Seventeen patients with type 2 DM and metabolic syndrome were supplemented with either 30 mg of elemental zinc/day or placebo for eight weeks .
-METHODS	Transmembrane TNF -- expressing monocytes and lymphocytes , and plasma TNF - levels were analyzed before and after supplementation .
-RESULTS	The present study revealed that zinc supplementation significantly increased the proportion of monocytes expressing transmembrane TNF - .
-RESULTS	While the plasma TNF - levels and TNF - expressing lymphocytes were not significantly altered in the zinc-treated and placebo groups , higher proportion of TNF - bound monocytes were observed in the zinc-treated group .
-CONCLUSIONS	Because functional transmembrane TNF - was shown to be implicated in defense mechanisms , these findings suggest that zinc supplementation may benefit immune response against cancer in patients with DM and metabolic syndrome .
-
-###24387824
-OBJECTIVE	To assess the interobserver agreement in 50 patients with hepatocellular carcinoma ( HCC ) before and 1 month after intra-arterial therapy ( IAT ) using two semi-automated methods and a manual approach for the following functional , volumetric and morphologic parameters : ( 1 ) apparent diffusion coefficient ( ADC ) , ( 2 ) arterial phase enhancement ( AE ) , ( 3 ) portal venous phase enhancement ( VE ) , ( 4 ) tumor volume , and assessment according to ( 5 ) the Response Evaluation Criteria in Solid Tumors ( RECIST ) , and ( 6 ) the European Association for the Study of the Liver ( EASL ) .
-METHODS	This HIPAA-compliant retrospective study had institutional review board approval .
-METHODS	The requirement for patient informed consent was waived .
-METHODS	Tumor ADC , AE , VE , volume , RECIST , and EASL in 50 index lesions was measured by three observers .
-METHODS	Interobserver reproducibility was evaluated using intraclass correlation coefficients ( ICC ) .
-METHODS	P < 0.05 was considered to indicate a significant difference .
-RESULTS	Semi-automated volumetric measurements of functional parameters ( ADC , AE , and VE ) before and after IAT as well as change in tumor ADC , AE , or VE had better interobserver agreement ( ICC = 0.830-0 .974 ) compared with manual ROI-based axial measurements ( ICC = 0.157-0 .799 ) .
-RESULTS	Semi-automated measurements of tumor volume and size in the axial plane before and after IAT had better interobserver agreement ( ICC = 0.854-0 .996 ) compared with manual size measurements ( ICC = 0.543-0 .596 ) , and interobserver agreement for change in tumor RECIST size was also higher using semi-automated measurements ( ICC = 0.655 ) compared with manual measurements ( ICC = 0.169 ) .
-RESULTS	EASL measurements of tumor enhancement in the axial plane before and after IAT ( ( ICC = 0.758-0 .809 ) , and changes in EASL after IAT ( ICC = 0.653 ) had good interobserver agreement .
-CONCLUSIONS	Semi-automated measurements of functional changes assessed by ADC and VE based on whole-lesion segmentation demonstrated better reproducibility than ROI-based axial measurements , or RECIST or EASL measurements .
-
-###24404816
-BACKGROUND	Telemedicine is one approach to managing patients with chronic illness .
-BACKGROUND	Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin ( HbA1c ) , blood pressure ( BP ) , and low-density lipoprotein ( LDL ) levels .
-BACKGROUND	The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes .
-BACKGROUND	The device was used to transmit weekly blood glucose , weight , and BP readings to a diabetes care manager .
-METHODS	We conducted a two-arm , parallel-comparison , single-blind , randomized controlled trial among Kaiser Permanente Northern California members 18-75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5 % and 10.0 % .
-METHODS	Participants were randomly assigned to either the telemonitoring arm or the usual care arm .
-RESULTS	We observed very small , nonsignificant changes in fructosamine ( telemonitoring , -54.9 mol ; usual care , -59.4 mol ) and systolic BP ( telemonitoring , -6.3 mm Hg ; usual care , -3.2 mm Hg ) from baseline to 6 weeks in both groups .
-RESULTS	At 6 months , we observed no significant intergroup differences in change from baseline for HbA1c , fructosamine , or self-efficacy .
-RESULTS	However , LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm ( -17.1 mg/dL versus -5.4 mg/dL ; P = 0.045 ) .
-CONCLUSIONS	Although HbA1c improved significantly over 6 months in both groups , the difference in improvement between the groups was not significant .
-CONCLUSIONS	This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa , CA clinic .
-CONCLUSIONS	Further study in subgroups of less healthy diabetes patients is recommended .
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-###24524697
-OBJECTIVE	To investigate the effect of low glycemic index ( LGI ) carbohydrate meal on subjective , metabolic and physiological responses , and endurance performance in the Ramadan fasted state .
-METHODS	During Ramadan , 12 Muslim men , in a randomized and crossover design , ingested for the sahur meal ( i.e. , last meal before commencement of the day 's fast ) , either LGI ( glycemic index = 37 ) or mixed ( CON ; 57 ) meal of equivalent macro-nutrient .
-METHODS	At 12h post-prandial , subjects completed a 60min continuous run .
-RESULTS	There were no significant differences between the two meals for ratings in perceived satiety , fullness , appetite and mood states .
-RESULTS	During steady-state exercise , there were no significant differences in metabolic and physiological measures .
-RESULTS	In the time-trial , distance ran was significantly lower in LGI versus CON meal trial , but with a corresponding lower perceived exertion in the LGI trial .
-CONCLUSIONS	Compared to CON , ingesting LGI as the sahur meal did not provide any metabolic , physiological or performance benefits during endurance run performed 12h post-prandial in Ramadan fasted state .
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-###24949949
-BACKGROUND	Varenicline was developed to aid smoking cessation by reducing smoking reinforcement .
-BACKGROUND	The present study tests this reinforcement-reduction hypothesis among smokers preparing to quit .
-METHODS	After a one-week baseline , treatment-seeking smokers were randomized to receive three weeks of varenicline or placebo ( Weeks 2-4 ) .
-METHODS	During each of the four weeks of the study , smokers completed a hypothetical cigarette purchase task ( CPT ) via handheld devices in their natural environment .
-METHODS	Behavioral economic measures of simulated smoking if cigarettes were free ( demand intensity ) , sensitivity of consumption to increasing price ( elasticity ) , and price at which purchases would drop to 0 ( breakpoint ) were estimated .
-RESULTS	The exponential demand equation fit the purchase task data well across subjects and time .
-RESULTS	As predicted , demand intensity decreased and sensitivity to price ( elasticity ) increased over time .
-RESULTS	However , changes in demand intensity did not differ by treatment group .
-RESULTS	Contrary to our hypothesis that varenicline would increase sensitivity to price , the placebo group tended to become more elastic in their purchases during Weeks 2 and 3 ; the groups did not differ in elasticity at Week 4 .
-RESULTS	Breakpoint did not vary by group , time , or their interaction .
-CONCLUSIONS	Simulated smoking demand can be validly assessed in the natural environment of treatment-seeking smokers .
-CONCLUSIONS	Simulated demand indices of smoking reinforcement diminished as smokers approached their target quit date .
-CONCLUSIONS	However , there was no evidence that varenicline facilitated these changes over a three-week period , leaving open the mechanisms by which varenicline reduces smoking rate prior to cessation and improves long-term abstinence .
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-###25015649
-OBJECTIVE	In 2010 , we reported that selenium ( Se ) supplementation during radiation therapy ( RT ) is effective for increasing blood Se levels in Se-deficient cervical and uterine cancer patients , and reduced the number of episodes and severity of RT-induced diarrhea .
-OBJECTIVE	In the current study , we examine whether of Se supplementation during adjuvant RT affects long-term survival of these patients .
-METHODS	Former patients were identified and questioned with respect to their health and well-being .
-RESULTS	A total of 81 patients were randomized in the initial supplementation study , 39 of whom received Se ( selenium group , SeG ) and 42 of whom served as controls ( control group , CG ) .
-RESULTS	When former patients were reidentified after a median follow-up of 70 months ( range = 0-136 ) , the actuarial 10-year disease-free survival rate in the SeG was 80.1 % compared to 83.2 % in the CG ( P = .65 ) , and the actuarial 10-year overall survival rate of patients in the SeG was 55.3 % compared to 42.7 % in the CG ( P = .09 ) .
-CONCLUSIONS	Our extended follow-up analysis demonstrates that Se supplementation had no influence on the effectiveness of the anticancer irradiation therapy and did not negatively affect patients ' long-term survival .
-CONCLUSIONS	In view of its positive effects on RT-induced diarrhea , we consider Se supplementation to be a meaningful and beneficial adjuvant treatment in Se-deficient cervical and uterine cancer patients while undergoing pelvic radiation therapy .
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-###25644360
-BACKGROUND	A long oral exposure to food and a high-energy density of food have been shown to increase satiety feelings .
-BACKGROUND	The effect of energy density is predominantly caused by an inhibition of gastric emptying .
-BACKGROUND	It is hypothesized that prolonging oral exposure may have an additional effect on this inhibition of gastric emptying .
-BACKGROUND	However , little human data are available to support this hypothesis .
-OBJECTIVE	The objective was to assess the effect of the duration of oral exposure to food on gastric emptying rate of gastric loads ( GLs ) low and high in energy density and on satiety feelings .
-METHODS	Twenty-six healthy men [ mean SD age : 22 3 y ; BMI ( in kg/m ( 2 ) ) : 23 1 ] participated in a randomized crossover trial with 4 treatments and a control .
-METHODS	Treatments consisted of either 1 - or 8-min modified sham feeding ( MSF ) of cake , and a GL of either 100 or 700 kcal infused in the stomach via a nasogastric tube ( 500 mL , 62.5 mL/min ) .
-METHODS	The control consisted of no MSF and a GL of 500 mL of water .
-METHODS	Gastric emptying rate was assessed with a ( 13 ) C breath test .
-METHODS	Breath samples and satiety feelings were collected at fixed time points until 90 min after start of the treatment .
-RESULTS	Gastric emptying rate and satiety feelings were not affected by duration of MSF ( P 0.27 ) .
-RESULTS	However , the 700-kcal GL treatments slowed gastric emptying [ 41 % lower area under the curve ( AUC ) ] and increased satiety feelings ( 22-31 % higher AUC ) compared with the 100-kcal GL treatments ( P < 0.001 ) .
-RESULTS	No interaction between MSF duration and energy density of GL was found ( P 0.44 ) .
-CONCLUSIONS	Higher gastric energy density inhibited gastric emptying and increased satiety feelings in healthy young men .
-CONCLUSIONS	However , prolonging oral exposure to food did not have an additional effect .
-CONCLUSIONS	This study provides more insight in satiety regulation .
-CONCLUSIONS	This trial was registered at trialregister.nl as NTR3601 .
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-###24354519
-BACKGROUND	Many recent studies suggest that the kallikrein-kinin system play a protective role in the impairment of vascular smooth muscle cells and vascular endothelial cell .
-OBJECTIVE	The study aims to determine whether tissue kallikrein is efficacy for preventing the long-term in-stent restenosis after stenting of symptomatic atherosclerotic stenosis of the middle cerebral artery M1 segment .
-METHODS	This is a Phase II , randomized , single-blinded , controlled trial .
-METHODS	In line with SAMMPRIS stenting indications , patients ( n = 90 ) with the symptomatic the middle cerebral artery M1 segment stenosis 70 % and successfully treated with stent will be enrolled .
-METHODS	Eligible patients will be randomized using computer generated numbers , and allocated to receive tissue kallikrein treatment or not .
-METHODS	Patients in tissue kallikrein treatment group will be prescribed with intravenous infusion of tissue kallikrein ( 0.15 PNAU/d , dissolved in 100 ml saline ) for 7 days after stenting and then oral administration of pancreatic kallikrein enteric-coated tablet ( 240 U , 3/d ) to the end of study .
-METHODS	As the foundation treatment , all the enrolled patients will receive aspirin ( 100 mg/d ) , clopidogrel ( 75 mg/d ) , and atorvastatin ( 20 mg/d ) for the first 6 months and continue with the combination of aspirin and atorvastatin at the previous dosage .
-RESULTS	Patients will be evaluated at 1 , 6 and 12 months after stenting .
-RESULTS	The primary outcomes are the in-stent restenosis rate , new stroke or aggravation of the previous ischemic stroke ipsilateral to the severe stenotic artery .
-RESULTS	Secondary outcomes include stroke of other artery territories , myocardial infarction and vascular death .
-RESULTS	Modification of stroke knowledge , exercise and diet habit , smoking cessation and available laboratory data will also be recorded .
-CONCLUSIONS	As our pilot study , tissue kallikrein would be expected to prevent the long-term in-stent restenosis after stenting of the symptomatic middle cerebral artery dramatically .
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-###24349550
-BACKGROUND	Advanced glycation end product ( AGE ) accumulation is thought to be a measure of cumulative metabolic stress that has been reported to independently predict cardiovascular disease in diabetes and renal failure .
-BACKGROUND	The aim of this study was to evaluate the association between AGE accumulation , measured as skin autofluorescence , and the progression of renal disease in pre-dialysis patients with chronic kidney disease ( CKD ) .
-METHODS	Skin autofluorescence was measured noninvasively with an autofluorescence reader at baseline in 449 pre-dialysis patients with CKD .
-METHODS	The primary end point was defined as a doubling of serum creatinine and/or need for dialysis .
-RESULTS	Thirty-three patients were lost to follow-up .
-RESULTS	Forty six patients reached the primary end point during the follow-up period ( Median 39 months ) .
-RESULTS	Kaplan-Meier analysis showed a significantly higher risk of development of the primary end points in patients with skin autofluorescence levels above the optimal cut-off level of 2.31 arbitrary units , derived by receiver operator curve analysis .
-RESULTS	Cox regression analysis revealed that skin autofluorescence was an independent predictor of the primary end point , even after adjustment for age , gender , smoking history , diabetes , estimated glomerular filtration rate and proteinuria ( adjusted hazard ratio 2.58 , P = 0.004 ) .
-CONCLUSIONS	Tissue accumulation of AGEs , measured as skin autofluorescence , is a strong and independent predictor of progression of CKD .
-CONCLUSIONS	Skin autofluorescence may be useful for risk stratification in this group of patients ; further studies should clarify whether AGE accumulation could be one of the therapeutic targets to improve the prognosis of CKD .
-
-###25304836
-BACKGROUND	There is no consensus on the optimal perioperative antibiotic prophylaxis regimen for renal transplant recipients .
-BACKGROUND	Some studies have reported that irrigation of the wound at the time of closure without systemic antibiotics may suffice to minimize the risk for surgical site infection ( SSI ) , but many centers still use long-term , multidose regimens in which antibiotics are administered until removal of foreign bodies occur , such as the urethral catheter , drain and central line .
-METHODS	We designed a prospective , randomized , multicenter , controlled trial to compare a single dose versus a multidose regimen of systemic antibiotic prophylaxis in adult , nondiabetic , non-morbidly obese patients undergoing renal transplantation .
-METHODS	The primary endpoint was the incidence of SSI ; the assessment of other infection in the first postoperative month was the secondary endpoint .
-RESULTS	Two hundred five patients were enrolled and randomized to receive either a single ( n = 103 ) or multidose antibiotic regimen ( n = 102 ) for prophylaxis .
-RESULTS	The incidences of SSI and urinary tract infection were similar in both groups .
-CONCLUSIONS	As the dramatic increase in antibiotic resistance has mandated the implementation of global programs to optimize the use of antibiotic agents in humans , we believe that the single dose regimen is preferred , at least in nondiabetic , non-morbidly obese , adult renal transplant recipients .
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-###24891946
-OBJECTIVE	To investigate the relationship between binge eating behavior and weight loss maintenance over a two-year period in adults .
-METHODS	Secondary data analysis using the Keep It Off study , a randomized trial evaluating an intervention to promote weight loss maintenance .
-METHODS	419 men and women ( ages : 20 to 70y ; BMI : 20-44kg / m2 ) who had intentionally lost 10 % of their weight during the previous year .
-METHODS	Body weight was measured and binge eating behavior over the past 6 months was reported at baseline , 12 months and 24 months .
-METHODS	Height was measured at baseline .
-RESULTS	Prevalence of binge eating at baseline was 19.4 % ( n = 76 ) .
-RESULTS	Prevalence of binge eating at any time point was 30.1 % ( n = 126 ) .
-RESULTS	Although rate of weight regain did not differ significantly between those who did or did not report binge eating at baseline , binge eating behavior across the study period ( additive value of presence or absence at each time point ) was significantly associated with different rates of weight regain .
-CONCLUSIONS	Tailoring weight loss maintenance interventions to address binge eating behavior is warranted given the prevalence and the different rates of weight regain experienced by those reporting this behavior .
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-###24435414
-OBJECTIVE	To assess whether the increased sensitivity of screening for human papillomavirus ( HPV ) may represent overdiagnosis and to compare the long term duration of protective effect against cervical intraepithelial neoplasia grade 2 or worse ( CIN2 + ) in HPV based and cytology based screening .
-METHODS	13 year follow-up of the Swedescreen randomised controlled trial of primary HPV screening .
-METHODS	Organised cervical screening programme in Sweden .
-METHODS	12,527 women aged 32-38 attending organised screening were enrolled and randomised to HPV and cytology double testing ( intervention arm , n = 6257 ) or to cytology only , with samples frozen for future HPV testing ( control arm , n = 6270 ) .
-METHODS	Cumulative incidence of CIN2 + and CIN3 + ( Kaplan Meier curves ) .
-METHODS	Longitudinal test characteristics were calculated for cytology only , HPV testing only , and cytology and HPV testing combined , adjusting for censoring .
-RESULTS	The increased detection of CIN2 + in the intervention arm decreased over time .
-RESULTS	After six years , the cumulative incidence of CIN3 + was similar in both trial arms , and after 11 years the cumulative incidence of CIN2 + became similar in both arms .
-RESULTS	The longitudinal sensitivity of cytology for CIN2 + in the control arm at three years was similar to the sensitivity of HPV testing in the intervention arm at five years of follow-up : 85.94 % ( 95 % confidence interval 76.85 % to 91.84 % ) v 86.40 % ( 79.21 % to 91.37 % ) .
-RESULTS	The sensitivity of HPV screening for CIN3 + after five years was 89.34 % ( 80.10 % to 94.58 % ) and for cytology after three years was 92.02 % ( 80.59 % to 96.97 % ) .
-CONCLUSIONS	Over long term follow-up , the cumulative incidence of CIN2 + was the same for HPV screening and for cytology , implying that the increased sensitivity of HPV screening for CIN2 + reflects earlier detection rather than overdiagnosis .
-CONCLUSIONS	The low long term risks of CIN3 + among women who tested negative in HPV screening , support screening intervals of five years for such women .
-BACKGROUND	Clinicaltrials.gov NCT00479375 .
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-###24300901
-BACKGROUND	In the US , past month tobacco use is higher among young adults aged 18-25 years than among any other age group .
-BACKGROUND	Neighborhood disorder may be a malleable environmental determinant of tobacco use among young adults ; its correlation with tobacco use is understudied .
-BACKGROUND	The purpose of this study is to examine whether perceived and objectively measured neighborhood factors are associated with tobacco use among young adults in Baltimore City .
-METHODS	This cross-sectional study of predominately African American young adults ( n = 359 ) used logistic regression models via generalized estimating equations ( GEE ) to estimate the association of perceived and objective neighborhood disorder with past month tobacco use , adjusting for race , age , sex , income , and other substance use .
-METHODS	Two measures of perceived neighborhood environment - neighborhood drug involvement , and neighborhood social cohesion - were derived from the Neighborhood Environment Scale ( NES ) .
-METHODS	Objective neighborhood disorder was measured via trained field raters using the Neighborhood Inventory for Environmental Typology ( NIfETy ) instrument .
-RESULTS	Sex modified the relationship between perceived neighborhood drug involvement and past month tobacco use , and the association was significant among women only ( aOR = 1.49 ; 95 % CI = 1.19-1 .88 ) .
-RESULTS	Perceptions of neighborhood social cohesion ( aOR = 0.97 ; 95 % CI = 0.83-1 .13 ) , and objective neighborhood disorder ( aOR = 1.17 ; 95 % CI = 0.98-1 .38 ) were not significantly associated with past month tobacco use .
-CONCLUSIONS	Understanding the correlation between perceived and objective neighborhood disorder , and their independent association with tobacco use can potentially lead to environmentally based interventions aimed at reducing tobacco use among young adults who live in urban environments .
-
-###24972557
-BACKGROUND	Severe perineal tears sustained during childbirth cause significant distress and morbidity amongst women .
-BACKGROUND	The objective of this study was to compare the use of straight scissors for cutting an episiotomy with the use of curved scissors , which are designed to curve away from the anal sphincter .
-METHODS	We used a single-centre , randomised feasibility trial .
-METHODS	The intervention was the use of curved scissors .
-METHODS	Women were recruited during a prenatal visit and randomised in the delivery suite , when it became clear that an episiotomy was required .
-METHODS	The feasibility outcomes were the proportion of women able to be recruited , randomised and followed up .
-METHODS	We also calculated the incidence of obstetric anal sphincter injury when either straight or curved scissors were used to cut an episiotomy .
-METHODS	Other outcomes assessed were pain , length of hospital stay , perineal infection and perineal dehiscence .
-RESULTS	Of the 155 patients recruited in the prenatal period , only 20 ( 12.9 % ) were eventually randomised at birth .
-RESULTS	The main reasons for the high loss were that women either did not have a vaginal delivery ( 38 , 24.5 % ) , or they did not need an episiotomy ( 72 , 46.5 % ) .
-RESULTS	Rates of obstetric anal sphincter injury and other outcomes were similar between groups .
-CONCLUSIONS	Anal sphincter injury during childbirth remains an important problem .
-CONCLUSIONS	Although the use of curved scissors provides a theoretical solution , we found that the high attrition rate made feasibility of conducting a suitably powered , randomised trial using the current design untenable .
-CONCLUSIONS	Alternative strategies have been suggested to make any future study more viable .
-
-###25434315
-OBJECTIVE	To assess the antiviral efficacy of lamivudine ( LAM ) , entecavir ( ETV ) , telbivudine ( LDT ) , and lamivudine and adefovir dipivoxil ( CLA ) combination in previously untreated hepatitis B patients at different time points during a 52-week treatment period .
-METHODS	A total of 164 patients were included in this prospective , open-label , head-to-head study .
-METHODS	Serum levels of alanine transaminase ( ALT ) , hepatitis B virus ( HBV ) DNA , and hepatitis B e antigen ( HBeAg ) were measured at baseline , and at 12 , 24 , and 52 weeks of treatment .
-RESULTS	Median reductions in serum HBV DNA levels at 52 weeks ( log 10 copies/mL ) were as follows : LAM , 3.98 ; ETV , 3.89 ; LDT , 4.11 ; and CLA , 3.36 .
-RESULTS	The corresponding HBV DNA undetectability rates were 83 % , 96 % , 91 % , and 89 % , respectively .
-RESULTS	These two measures showed no significant intergroup differences .
-RESULTS	Clinical efficacy appeared related to HBV DNA level reduction after 24 weeks of therapy .
-RESULTS	Patients were divided into three groups based on HBV DNA levels at week 24 : Undetectable ( < 10 ( 3 ) copies/mL ) , detectable but < 10 ( 4 ) copies/mL , and > 10 ( 4 ) copies/mL .
-RESULTS	Patients with levels below quantitation limit ( QL ) were analyzed at 52 weeks for HBV DNA undetectability rate ( 94 % ) , ALT normalization rate ( 83 % ) , and viral breakthrough rate ( 0 % ) .
-RESULTS	The corresponding values in the QL-10 ( 4 ) copies/mL group were 50 % , 75 % , and 13 % , whereas those in the above 10 ( 4 ) copies/mL group were 53 % , 65 % , and 18 % .
-RESULTS	There were significant differences at week 52 for HBV DNA levels and viral breakthrough rate between the three groups .
-CONCLUSIONS	Different nucleos ( t ) ide ( NUC ) analogues tested exhibited no significant differences in effectiveness for Chinese NUC-naive HBV patients during 1-year treatment period .
-
-###24729102
-BACKGROUND	Chronic renal failure is a progressive and irreversible loss of kidney function , and the hemodialysis ( HD ) is one of the most common modalities in this regard .
-BACKGROUND	Oxidative stresses [ like interleukin-8 ( IL-8 ) and tumor necrosis factor-alpha ( TNF - ) ] and inflammation are the main risk factors associated with cardiovascular diseases and other complications in many organs in hemodialysis patients ; meanwhile , antioxidants like alpha lipoic acid ( ALA ) may reduce the oxidative stress markers and the levels of inflammatory cytokines , so can improve of the patient 's quality of life .
-METHODS	In this randomized clinical trial study , 60 HD patients were randomly categorized in two case and control groups .
-METHODS	Case group received a daily capsule of 600 mg of ALA supplementation for 8 weeks , and the control group received placebo capsules daily .
-METHODS	The serum level of IL-8 and TNF - was measured in both groups before and after the intervention .
-RESULTS	There were no significant differences in age , gender , duration of dialysis , and causative factor for dialysis between both groups ( P > 0.05 ) .
-RESULTS	The mean of IL-8 and TNF - after the intervention in case group was 26.20 15.34 and 21.25 9.61 , respectively ; the difference between both groups was not statistically significant ( P > 0.05 ) .
-CONCLUSIONS	Based on the better feeling and other beneficial effects of ALA were found in our study ; we can conclude that it is a beneficial and recommended supplement , especially , for diabetic and dialysis patients .
-
-###24253138
-OBJECTIVE	To compare the efficacy and safety of antithrombotic prophylaxis given for 1 week or 4 weeks in patients undergoing laparoscopic surgery for colorectal cancer .
-BACKGROUND	Extending antithrombotic prophylaxis beyond 1 week reduces the incidence of venous thromboembolism ( VTE ) after open abdominal surgery for cancer .
-METHODS	In consecutive patients who underwent laparoscopic surgery for colorectal cancer , complete compression ultrasonography of the lower limbs was performed after 8 2 days of antithrombotic prophylaxis .
-METHODS	Patients with no evidence of VTE were randomized to short ( heparin withdrawal ) or to extended ( heparin continued for 3 additional weeks ) prophylaxis .
-METHODS	Complete compression ultrasonography was repeated at day 28 2 after surgery by investigators blinded to treatment allocation .
-METHODS	The primary outcome of the study was the composite of symptomatic and ultrasonography-detected VTE at day 28 2 after surgery .
-RESULTS	Overall , 301 patients were evaluated for inclusion in the study and 225 were randomized .
-RESULTS	VTE occurred in 11 of 113 patients randomized to short ( 9.7 % ) and in none of the 112 patients randomized to extended heparin prophylaxis ( P = 0.001 ) .
-RESULTS	The incidence of VTE at 3 months was 9.7 % and 0.9 % in patients randomized to short or to extended heparin prophylaxis , respectively ( relative risk reduction : 91 % , 95 % confidence interval : 30 % -99 % ; P = 0.005 ) .
-RESULTS	The rate of bleeding was similar in the 2 treatment groups .
-RESULTS	Two patients died during the study period , 1 in each treatment group .
-CONCLUSIONS	After laparoscopic surgery for colorectal cancer , extended antithrombotic prophylaxis is safe and reduces the risk for VTE as compared with 1-week prophylaxis ( NCT01589146 ) .
-
-###24903351
-OBJECTIVE	We examined the effect of a single apple juice intake on the pharmacokinetics of fexofenadine enantiomers in healthy Japanese subjects .
-METHODS	In a randomized two phase , open-label crossover study , 14 subjects received 60mg of racemic fexofenadine simultaneously with water or apple juice .
-METHODS	For the uptake studies , oocytes expressing organic anion-transporting polypeptide 2B1 ( OATP2B1 ) were incubated with 100M ( R ) - and ( S ) - fexofenadine in the presence or absence of 10 % apple juice .
-RESULTS	One-time ingestion of apple juice significantly decreased the area under the plasma concentration-time curve ( AUC0-24 ) for ( R ) - and ( S ) - fexofenadine by 49 and 59 % , respectively , and prolonged the time to reach the maximum plasma concentration ( t max ) of both enantiomers ( P < 0.001 ) .
-RESULTS	Although apple juice greatly reduced the amount of ( R ) - and ( S ) - fexofenadine excretion into urine ( Ae0-24 ) by 54 and 58 % , respectively , the renal clearances of both enantiomers were unchanged between the control and apple juice phases .
-RESULTS	For in vitro uptake studies , the uptake of both fexofenadine enantiomers into OATP2B1 complementary RNA ( cRNA ) - injected oocytes was significantly higher than that into water-injected oocytes , and this effect was greater for ( R ) - fexofenadine .
-RESULTS	In addition , apple juice significantly decreased the uptake of both enantiomers into OATP2B1 cRNA-injected oocytes .
-CONCLUSIONS	These results suggest that OATP2B1 plays an important role in the stereoselective pharmacokinetics of fexofenadine and that one-time apple juice ingestion probably inhibits intestinal OATP2B1-mediated transport of both enantiomers .
-CONCLUSIONS	In addition , this study demonstrates that the OATP2B1 inhibition effect does not require repeated ingestion or a large volume of apple juice .
-
-###25245439
-OBJECTIVE	The introduction of all-trans-retinoic acid ( ATRA ) has significantly improved outcomes for acute promyelocytic leukemia ( APL ) , although a subset of patients still suffer relapse .
-OBJECTIVE	The purpose of this study was to evaluate the role of maintenance therapy with the synthetic retinoid tamibarotene in APL .
-METHODS	Patients with newly diagnosed APL in molecular remission at the end of consolidation therapy were randomly assigned to receive ATRA or tamibarotene , both orally , for 14 days every 3 months for up to 2 years .
-RESULTS	A total of 347 patients were enrolled .
-RESULTS	Of the 344 eligible patients , 319 ( 93 % ) achieved complete remission .
-RESULTS	After completing three courses of consolidation therapy , 269 patients underwent maintenance random assignment .
-RESULTS	The relapse-free survival ( RFS ) rate at 4 years was 84 % for the ATRA arm and 91 % for the tamibarotene arm ( hazard ratio [ HR ] , 0.54 ; 95 % CI , 0.26 to 1.13 ) .
-RESULTS	When the analysis was restricted to 52 high-risk patients with an initial WBC count 10.0 10 ( 9 ) / L , the intergroup difference was statistically significant , with 4-year RFS rates of 58 % for the ATRA arm and 87 % for the tamibarotene arm ( HR , 0.26 ; 95 % CI , 0.07 to 0.95 ) .
-RESULTS	For patients with non-high-risk disease , the HR was 0.82 ( 95 % CI , 0.32 to 2.01 ) .
-RESULTS	The test for interaction between treatment effects and these subgroups resulted in P = .075 .
-RESULTS	Both treatments were generally well tolerated .
-CONCLUSIONS	In this trial , no difference was detected between ATRA and tamibarotene for maintenance therapy .
-CONCLUSIONS	In an exploratory analysis , there was a suggestion of improved efficacy of tamibarotene in high-risk patients , but this requires further study .
-
-###24913210
-OBJECTIVE	Medical students often lack training in complex geriatric medical decision making .
-OBJECTIVE	We therefore developed the serious game , GeriatriX , for training medical decision making with weighing patient preferences , and appropriateness and costs of medical care .
-OBJECTIVE	We hypothesized that education with GeriatriX would improve the ability to deal with geriatric decision making and also increase cost consciousness .
-METHODS	A randomized , controlled pre-post measurement design .
-METHODS	Fifth-year medical students .
-METHODS	Playing the serious game GeriatriX as an additive to usual geriatric education .
-METHODS	We evaluated the effects of playing GeriatriX on self-perceived knowledge of geriatric themes and the self-perceived competence of weighing patient preferences , appropriateness , and costs of medical care in geriatric decision making .
-METHODS	Cost consciousness was evaluated with a postmeasurement to estimate costs of different diagnostic tests .
-RESULTS	There was a large positive increase in the self-perceived competence of weighing patient preferences , appropriateness , and costs of medical care in the intervention group ( n = 71 ) ( effect sizes of 0.7 , 1.0 , and 1.2 , respectively ) , which was significantly better for the last 2 aspects than in the control group ( n = 63 ) .
-RESULTS	The intervention group performed better on cost consciousness .
-RESULTS	Although the self-perceived knowledge increased substantially on some geriatric topics , this improvement was not different between the intervention and control groups .
-CONCLUSIONS	After playing the serious game , GeriatriX , medical students have a higher self-perceived competence in weighing patient preferences , appropriateness , and costs of medical care in complex geriatric medical decision making .
-CONCLUSIONS	Playing GeriatriX also resulted in better cost consciousness .
-CONCLUSIONS	We therefore encourage wider use of GeriatriX to teach geriatrics in medical curricula and its further research on educational and health care outcomes .
-
-###25242512
-OBJECTIVE	To evaluate the mid-to long-term results of a randomized controlled trial of single-bundle ( SB ) versus double-bundle ( DB ) anterior cruciate ligament ( ACL ) reconstruction using a semitendinosus tendon .
-METHODS	Seventy-eight patients who underwent primary ACL reconstruction with an autologous semitendinosus tendon were prospectively randomized into 2 groups : SB reconstruction ( n = 39 ) and DB reconstruction ( n = 39 ) .
-METHODS	In both groups , grafts were fixed at 30 of flexion with a total tension of 80 N.
-METHODS	The following evaluation methods were used : clinical examination , KT-1000 arthrometer ( MEDmetric , San Diego , CA ) measurement , muscle strength , Tegner activity score , Lysholm score , subjective rating scale regarding patient satisfaction and sports performance level , graft retear , contralateral ACL tear , and additional meniscus surgery .
-RESULTS	Fifty-three patients ( 25 in SB group and 28 in DB group ) who were followed up for a minimum of 3 years ( mean , 69 months ; range , 36 to 140 months ) were evaluated .
-RESULTS	Preoperatively , there were no differences between the groups .
-RESULTS	Postoperatively , the Lachman and pivot-shift test results were better in the DB group ( P = .024 and P < .0001 , respectively ) .
-RESULTS	KT measurements were better in the DB group ( mean , 1.4 mm v 2.7 mm ; P = .0023 ) .
-RESULTS	The Tegner score was also better in the DB group ( P = .033 ) .
-RESULTS	There were no significant differences in range of motion , muscle strength , Lysholm score , subjective rating scale , graft retear , and secondary meniscal tear .
-CONCLUSIONS	In ACL reconstruction using the transtibial approach , DB reconstruction was significantly better than SB reconstruction regarding anterior and rotational stability during the 3 - to 12-year follow-up .
-CONCLUSIONS	The results of KT measurements and the Lachman and pivot-shift tests were significantly better in the DB group , whereas there was no difference in the anterior drawer test results .
-CONCLUSIONS	The Tegner score was also better in the DB group ; however , there were no differences in the other subjective findings .
-METHODS	Level II , lesser-quality prospective randomized trial .
-
-###24705623
-OBJECTIVE	The study aim is to investigate synergistic effects of cilostazol and probucol combination therapy on coronary plaque volume and composition .
-METHODS	A total of 119 patients undergoing coronary stenting were treated with probucol and cilostazol combination therapy ( group ) or with cilostazol monotherapy ( group ) in a double-blind , randomized multicenter trial , and evaluated by virtual histology intravascular ultrasound ( VH-IVUS ) at baseline and 9-month follow-up for changes in coronary plaque volume and composition at an index intermediate lesion with luminal narrowing 30 % and 70 % and for neointimal hyperplasia at the stented segment .
-METHODS	In all patients simvastatin 20 mg was started with enrollment .
-RESULTS	Qualifying VH-IVUS data from 91 patients were included in the final analysis .
-RESULTS	There were no significant differences between group and with respect to the primary endpoint , nominal change in normalized total atheroma volume ( TAV ) of the index intermediate coronary lesion ( -12.617.7 vs. -14.220.2 mm ( 3 ) , p = 0.691 ) , or plaque composition .
-RESULTS	Plaque regression was observed in more than 70 % of patients in both groups .
-RESULTS	Diabetes was the only significant independent determinant of changes in TAV ( = 0.22 , p = 0.037 ) .
-RESULTS	There were greater decreases in total cholesterol ( -51.833.0 vs. -25.439.1 mg/dL , p0 .001 ) and LDL ( -33.530.5 vs. -20.330.8 mg/dL , p = 0.044 ) levels in group than in group .
-RESULTS	However , HDL cholesterol ( -11.28.5 vs. 2.77.7 mg/dL , p0 .001 ) and apoA1 ( -18.221.4 vs. 10.016.5 mg/dL , p0 .001 ) levels were also significantly decreased in group compared with group .
-CONCLUSIONS	There were no significant differences in changes in plaque volume or composition between the cilostazol and probucol combination therapy and cilostazol monotherapy group despite different impacts of the treatments on lipid biomarkers .
-
-###24968148
-BACKGROUND	Aspiration pneumonia is a leading cause of death in people with Parkinson disease ( PD ) .
-BACKGROUND	The pathogenesis of these infections is largely attributed to the presence of dysphagia with silent aspiration or aspiration without an appropriate cough response .
-BACKGROUND	The goal of this study was to test reflex cough thresholds and associated urge-to-cough ( UTC ) ratings in participants with PD with and without dysphagia .
-METHODS	Twenty participants with PD were recruited for this study .
-METHODS	They completed a capsaicin challenge with three randomized blocks of 0 , 50 , 100 , and 200 M capsaicin and rated their UTC by modified Borg scale .
-METHODS	The concentration of capsaicin that elicited a two-cough response , total number of coughs , and sensitivity of the participant to the cough stimulus ( UTC ) were measured .
-METHODS	The dysphagia severity of participants with PD was identified with the penetration-aspiration scale .
-RESULTS	Most participants with PD did not have a consistent two-cough response to 200 M capsaicin .
-RESULTS	UTC ratings and total number of coughs produced at 200 M capsaicin were significantly influenced by dysphagia severity but not by general PD severity , age , or disease duration .
-RESULTS	Increasing levels of dysphagia severity resulted in significantly blunted cough sensitivity ( UTC ) .
-CONCLUSIONS	UTC ratings may be important in understanding the mechanism underlying morbidity related to aspiration pneumonia in people with PD and dysphagia .
-CONCLUSIONS	Further understanding of decreased UTC in people with PD and dysphagia will be essential for the development of strategies and treatments to address airway protection deficits in this population .
-
-###24282626
-BACKGROUND	Fluoroquinolones are the most commonly used group of antimicrobials for the treatment of enteric fever , but no direct comparison between two fluoroquinolones has been performed in a large randomised trial .
-BACKGROUND	An open-label randomized trial was conducted to investigate whether gatifloxacin is more effective than ofloxacin in the treatment of uncomplicated enteric fever caused by nalidixic acid-resistant Salmonella enterica serovars Typhi and Paratyphi A.
-RESULTS	Adults and children clinically diagnosed with uncomplicated enteric fever were enrolled in the study to receive gatifloxacin ( 10 mg/kg/day ) in a single dose or ofloxacin ( 20 mg/kg/day ) in two divided doses for 7 days .
-RESULTS	Patients were followed for six months .
-RESULTS	The primary outcome was treatment failure in patients infected with nalidixic acid resistant isolates .
-RESULTS	627 patients with a median age of 17 ( IQR 9-23 ) years were randomised .
-RESULTS	Of the 218 patients with culture confirmed enteric fever , 170 patients were infected with nalidixic acid-resistant isolates .
-RESULTS	In the ofloxacin group , 6 out of 83 patients had treatment failure compared to 5 out of 87 in the gatifloxacin group ( hazard ratio [ HR ] of time to failure 0.81 , 95 % CI 0.25 to 2.65 , p = 0.73 ) .
-RESULTS	The median time to fever clearance was 4.70 days ( IQR 2.98-5 .90 ) in the ofloxacin group versus 3.31 days ( IQR 2.29-4 .75 ) in the gatifloxacin group ( HR = 1.59 , 95 % CI 1.16 to 2.18 , p = 0.004 ) .
-RESULTS	The results in all blood culture-confirmed patients and all randomized patients were comparable .
-CONCLUSIONS	Gatifloxacin was not superior to ofloxacin in preventing failure , but use of gatifloxacin did result in more prompt fever clearance time compared to ofloxacin .
-BACKGROUND	ISRCTN 63006567 ( www.controlled-trials.com ) .
-
-###25637195
-BACKGROUND	Intimate partner violence ( IPV ) and its associated negative mental health consequences are significant for women in New Zealand and internationally .
-BACKGROUND	One of the most widely recommended interventions is safety planning .
-BACKGROUND	However , few women experiencing violence access specialist services for safety planning .
-BACKGROUND	A safety decision aid , weighing the dangers of leaving or staying in an abusive relationship , gives women the opportunity to prioritise , plan and take action to increase safety for themselves and their children .
-BACKGROUND	This randomised controlled trial is testing the effectiveness of an innovative , interactive web-based safety decision aid .
-BACKGROUND	The trial is an international collaborative concurrent replication of a USA trial ( IRIS study NCT01312103 ) , regionalised for the Aotearoa New Zealand culture and offers fully automated online trial recruitment , eligibility screening and consent .
-METHODS	In a fully automated web-based trial ( isafe ) 340 abused women will be randomly assigned in equal numbers to a safety decision aid intervention or usual safety planning control website .
-METHODS	Intervention components include : ( a ) safety priority setting , ( b ) danger assessment and ( c ) an individually tailored safety action plan .
-METHODS	Self-reported outcome measures are collected at baseline and 3 , 6 , and 12-months post-baseline .
-METHODS	Primary outcomes are depression ( measured by Center for Epidemiologic Studies Depression Scale , Revised ) and IPV exposure ( measured by Severity Violence Against Women Scale ) at 12 months post-baseline .
-METHODS	Secondary outcomes include PTSD , psychological abuse , decisional conflict , safety behaviors and danger in the relationship .
-CONCLUSIONS	This trial will provide much-needed information on the potential relationships among safety planning , improved mental health , reduced violence as well as decreased decisional conflict related to safety in the abusive relationship .
-CONCLUSIONS	The novel web-based safety decision aid intervention may provide a cost-effective , easily accessed safety-planning resource that can be translated into clinical and community practice by multiple health disciplines and advocates .
-CONCLUSIONS	The trial will also provide information about how women in abusive relationships safely access safety information and resources through the Internet .
-CONCLUSIONS	Finally , the trial will inform other research teams on the feasibility and acceptability of fully automated recruitment , eligibility screening , consent and retention procedures .
-BACKGROUND	Trial registered on 03 July 2012 on the Australian New Zealand Clinical Trials Registry ACTRN12612000708853 .
-
-###25548122
-BACKGROUND	Cell-based strategies that combine in vitro - expanded autologous chondrocytes with matrix scaffolds are currently preferred for full-thickness cartilage lesions of the knee 2cm ( 2 ) .
-BACKGROUND	Although this approach is reasonable , continuing advances in the field of cartilage repair will further expand the options available to improve outcomes .
-OBJECTIVE	In the present clinical study , we compared the outcomes of matrix-induced autologous mesenchymal stem cell implantation ( m-AMI ) with matrix-induced autologous chondrocyte implantation ( m-ACI ) for the treatment of isolated chondral defects of the knee .
-METHODS	Prospective , single-site , randomized , single-blind pilot study .
-METHODS	Fourteen patients with isolated full-thickness chondral lesions of the knee > 2cm ( 2 ) were randomized into two treatment groups : m-AMI and m-ACI .
-METHODS	Outcomes were assessed pre-operatively and 3 , 6 , 12 and 24months post-operatively .
-RESULTS	Clinical evaluations revealed that improvement from pre-operation to 24months post-operation occurred in both groups ( p < 0.05 ) .
-RESULTS	At all follow-up intervals , m-AMI demonstrated significantly better functional outcomes ( motion deficit and straight leg raise strength ) than did m-ACI ( p < 0.05 ) .
-RESULTS	At all follow-up intervals , m-AMI demonstrated significantly better subjective sub-scale scores for pain , symptoms , activities of daily living and sport and recreation of the knee injury and osteoarthritis outcome score ( KOOS ) than did m-ACI ( p < 0.05 ) .
-RESULTS	Additionally , m-AMI demonstrated significantly better ( p < 0.05 ) scores than m-ACI for the quality of life sub-scale of the KOOS and visual analog scale ( VAS ) severity at the 6-month follow-up .
-RESULTS	The Tegner activity score and VAS frequency were not significantly different between the two groups .
-RESULTS	Graft failure was not observed on magnetic resonance imaging at the 24-month follow-up .
-RESULTS	m-AMI and m-ACI demonstrated very good-to-excellent and good-to-very good infill , respectively , with no adverse effects from the implant , regardless of the treatment .
-CONCLUSIONS	For the treatment of isolated full-thickness chondral lesion of the knee , m-AMI can be used effectively and may potentially accelerate recovery .
-CONCLUSIONS	A larger patient cohort and follow-up supported by histological analyses are necessary to determine long-term outcomes .
-
-###24354307
-OBJECTIVE	To evaluate the change in drusen volume following treatment with eculizumab , a systemic inhibitor of complement component 5 .
-METHODS	Single-center , prospective , randomized , double-masked clinical trial .
-METHODS	Patients were randomized 2:1 to receive intravenous eculizumab or placebo over 26 weeks .
-METHODS	decrease in drusen volume of at least 50 % at 26-week follow-up .
-RESULTS	Mean drusen cube root volumes were 0.49 mm and 0.47 mm ( P = .64 ) at baseline and 0.51 mm and 0.42 mm ( P = .17 ) at 26 weeks in the eculizumab and placebo groups , respectively .
-RESULTS	In the placebo group , one eye had a decrease in drusen volume of at least 50 % and two eyes developed neovascularization through 26 weeks .
-CONCLUSIONS	Systemic complement inhibition with eculizumab did not significantly reduce drusen volume .
-CONCLUSIONS	Drusen growth was dependent on the number of complement at-risk alleles .
-CONCLUSIONS	Future trials should consider the use of a composite clinical trial endpoint in which efficacy is defined by the treatments ability to prevent drusen growth , neovascularization , and the formation of geographic atrophy over 1 year .
-
-###25260436
-BACKGROUND	Left atrial ( LA ) strain is a sensitive measure of LA mechanics .
-BACKGROUND	However , its relationship with rhythm outcomes after catheter ablation in patients with atrial fibrillation ( AF ) is not well established .
-BACKGROUND	The aim of this study was to evaluate whether baseline LA global longitudinal strain ( LA ) predicts rhythm outcomes in patients who undergo catheter ablation for AF .
-METHODS	In 256 patients with AF ( paroxysmal , 204 ; persistent , 52 ) , comprehensive echocardiography was performed with assessment of LA by using Velocity Vector Imaging to calculate average strain values from apical four - and two-chamber views before ablation ( median , 41 days ; interquartile range , 1-95 days ) .
-RESULTS	After a median of 8.0 months ( interquartile range , 4.0-23 .3 months ) of follow-up , 149 patients ( 58 % ) had maintained sinus rhythm and 107 patients ( 42 % ) had recurrence of AF .
-RESULTS	In our study cohort ( mean age 5911years ; mean left ventricular ejection fraction , 5810 % ) , impaired total LA ( LAtotal ) was associated with greater left ventricular mass index ( r = -0.245 , P < .001 ) and worsening left ventricular diastolic function ( ratio of transmitral flow peak early diastolic velocity to peak early diastolic velocity of the mitral annulus : r = -0.357 , P < .001 ; maximal LA volume index : r = -0.393 , P < .001 ) .
-RESULTS	Patients with LAtotal < 23.2 % showed a higher incidence of AF recurrence compared with patients with LAtotal 23.2 % ( log-rank P < .001 ) .
-RESULTS	In multivariate Cox proportional-hazards analysis , LAtotal was independently related to rhythm outcomes ( hazard ratio , 0.944 ; 95 % confidence interval , 0.915-0 .975 ; P < .001 ) after AF ablation .
-RESULTS	Moreover , LAtotal provided incremental predictive value for rhythm outcomes over clinical features ( increment in global ( 2 ) = 14.63 , P < .001 ) .
-CONCLUSIONS	In patients with AF , baseline LAtotal was associated with rhythm outcome after catheter ablation .
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-###24287186
-BACKGROUND	Antimicrobial drugs are frequently prescribed to children for respiratory tract infections such as otitis , tonsillitis , sinusitis , and pneumonia .
-BACKGROUND	We assessed the effect of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine ( PHiD-CV10 ; GlaxoSmithKline ) on antimicrobial purchases .
-METHODS	In this nationwide phase 3-4 cluster-randomised , double-blind trial , children younger than 19 months were randomly assigned to receive PHiD-CV10 in 52 of 78 clusters or hepatitis B or A vaccine as control in 26 clusters according to three plus one or two plus one schedules ( infants younger than 7 months ) or catch-up schedules ( children aged 7-18 months ) .
-METHODS	The main objective for the antimicrobial treatment outcome was to assess vaccine effectiveness against outpatient prescriptions of antimicrobial drugs recommended by national treatment guidelines for acute otitis media in Finland in children who received at least one dose of study vaccine before 7 months of age .
-METHODS	Masked follow-up lasted from the date of first vaccination ( from Feb 18 , 2009 , through Oct 5 , 2010 ) to Dec 31 , 2011 .
-METHODS	We obtained data on all purchased antimicrobial prescriptions through the benefits register of the Social Insurance Institution of Finland .
-METHODS	This and the nested acute otitis media trial are registered at ClinicalTrials.gov , numbers NCT00861380 and NCT00839254 .
-RESULTS	More than 47,000 children were enrolled .
-RESULTS	In 30,527 infants younger than 7 months at enrollment , 98,436 outpatient antimicrobial purchases were reported with incidence of 1.69 per person-year in the control clusters .
-RESULTS	Analysis of the main objective included 91 % of all antimicrobial purchases : 31,982 in the control and 57,964 in the PHiD-CV10 clusters .
-RESULTS	Vaccine effectiveness was 8 % ( 95 % CI 1-14 ) and the incidence rate difference 0.12 per person-year corresponding to the number needed to vaccinate of five ( 95 % CI 3-67 ) to prevent one purchase during the 2 year follow-up for combined PHiD-CV10 three plus one and two plus one infant schedules .
-RESULTS	The vaccine effectiveness was identical for the two infant schedules .
-RESULTS	In the catch-up schedules , the vaccine effectiveness was 3 % ( 95 % CI -4 to 10 ) .
-CONCLUSIONS	Despite low relative rate reductions the absolute rate reductions were substantial because of the high incidence of the outcome .
-CONCLUSIONS	This reduction would lead to over 12,000 fewer antimicrobial purchases per year in children younger than 24 months in Finland ( birth cohort of 60,000 children ) .
-
-###24341101
-OBJECTIVE	To investigate the clinical efficacy of Shuganyiyang Capsule combined with conventional Western medicine ( tamsulosin hydrochloride sustained release tablets + prostat tablets ) for the treatment of type III prostatitis complicated by erectile dysfunction ( ED ) .
-METHODS	Eighty patients with type III prostatitis complicated by ED were equally randomized to an experimental and a control group , the former treated with Shuganyiyang Capsule combined with tamsulosin hydrochloride sustained release tablets and prostat tablets , while the latter with tamsulosin hydrochloride and prostat only , both for 8 weeks .
-METHODS	Then the prostatitis symptoms , erectile function and psychological conditions of the patients were evaluated using NIH-CPSI , IIEF-5 , and hospital anxiety and depression scale ( HADA and HADD ) respectively .
-METHODS	The rates of recovery , excellence , effectiveness and ineffectiveness were calculated .
-RESULTS	The scores on NIH-CPSI , IIEF-5 , HADA and HADD obtained at 4 and 8 weeks after treatment showed statistically significant differences between the two time points as well as from the baseline ( P < 0.01 ) .
-RESULTS	At 8 weeks , the scores on NIH-CPSI , IIEF-5 , HADA and HADD were 6.83 + / - 4.96 , 21.03 + / - 2.54 , 6.05 + / - 1.62 , and 5.35 + / - 3.30 in the experimental group , as compared with 7.55 + / - 4.89 , 17.68 + / - 4.15 , 6.88 + / - 2.45 , and 7.85 + / - 3.77 in the control ( P < 0.05 ) .
-RESULTS	The rate of effectiveness was significantly higher in the experimental than in the control group ( 90 % [ 36/40 ] vs 70 % [ 28/40 ] , P < 0.05 ) .
-CONCLUSIONS	Shuganyiyang Capsule combined with conventional Western medicine , such as alpha blockers and galenica , produces definite effect on chronic prostatitis complicated by ED , improves the psychological conditions of the patient , and enhances the therapeutic efficiency of chronic prostatits .
-
-###25443867
-OBJECTIVE	The purpose was to evaluate the effectiveness of Staying Healthy-Asthma Responsible & Prepared , an academic asthma health education and counseling program , on fostering the use of effective asthma self-care behaviors .
-METHODS	This was a phase III , two-group , cluster randomized , single-blinded , longitudinal design-guided study .
-METHODS	Caregivers of 205 fourth - and fifth-grade students completed the asthma health behaviors survey at preintervention , and 1 , 12 , and 24 months postintervention .
-METHODS	Analysis involved multilevel modeling .
-RESULTS	All students demonstrated improvement in episode management , risk reduction/prevention , and health promotion behaviors ; Staying Healthy-Asthma Responsible & Prepared students demonstrated increased improvement in episode management and risk reduction/prevention behaviors .
-CONCLUSIONS	Working with schoolteachers , nurses can improve the use of effective asthma self-care behaviors .
-
-###24746000
-BACKGROUND	Macrolide resistance is an increasing problem ; there is therefore debate about when to implement maintenance treatment with macrolides in patients with chronic obstructive pulmonary disease ( COPD ) .
-BACKGROUND	We aimed to investigate whether patients with COPD who had received treatment for three or more exacerbations in the previous year would have a decrease in exacerbation rate when maintenance treatment with azithromycin was added to standard care .
-METHODS	We did a randomised , double-blind , placebo-controlled , single-centre trial in The Netherlands between May 19 , 2010 , and June 18 , 2013 .
-METHODS	Patients ( 18 years ) with a diagnosis of COPD who had received treatment for three or more exacerbations in the previous year were randomly assigned , via a computer-generated randomisation sequence with permuted block sizes of ten , to receive 500 mg azithromycin or placebo three times a week for 12 months .
-METHODS	Randomisation was stratified by use of long-term , low-dose prednisolone ( 10 mg daily ) .
-METHODS	Patients and investigators were masked to group allocation .
-METHODS	The primary endpoint was rate of exacerbations of COPD in the year of treatment .
-METHODS	Analysis was by intention to treat .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT00985244 .
-RESULTS	We randomly assigned 92 patients to the azithromycin group ( n = 47 ) or the placebo group ( n = 45 ) , of whom 41 ( 87 % ) versus 36 ( 80 % ) completed the study .
-RESULTS	We recorded 84 exacerbations in patients in the azithromycin group compared with 129 in those in the placebo group .
-RESULTS	The unadjusted exacerbation rate per patient per year was 194 ( 95 % CI 150-252 ) for the azithromycin group and 322 ( 262-397 ) for the placebo group .
-RESULTS	After adjustment , azithromycin resulted in a significant reduction in the exacerbation rate versus placebo ( 058 , 95 % CI 042-079 ; p = 0001 ) .
-RESULTS	Three ( 6 % ) patients in the azithromycin group reported serious adverse events compared with five ( 11 % ) in the placebo group .
-RESULTS	During follow-up , the most common adverse event was diarrhoea in the azithromycin group ( nine [ 19 % ] patients vs one [ 2 % ] in the placebo group ; p = 0015 ) .
-CONCLUSIONS	Maintenance treatment with azithromycin significantly decreased the exacerbation rate compared with placebo and should therefore be considered for use in patients with COPD who have the frequent exacerbator phenotype and are refractory to standard care .
-BACKGROUND	SoLong Trust .
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-###25360652
-OBJECTIVE	To investigate the effect of ulinastatin , a urinary trypsin inhibitor , on the postoperative liver function in patients who have received bilateral total knee arthroplasty ( TKA ) under pneumatic tourniquet .
-METHODS	Totally 40 patients who were scheduled to receive bilateral TKA under thigh tourniquet were randomly assigned into trial group ( U group , receiving intravenous ulinastatin ) and control group ( C group , receiving natural saline ) .
-METHODS	All patients received the same general anesthesia and postoperative analgesia .
-METHODS	The plasma concentrations of alanine transaminase ( ALT ) , total bilirubin ( TBil ) , and direct bilirubin ( DBil ) were recorded and compared preoperatively and 4 , 24 , 48 , and 72 hours after the surgery .
-RESULTS	The demographic data were not significantly different between these two groups ( P > 0.05 ) .
-RESULTS	The ALT was not significantly changed after the surgery in the C group ( P > 0.05 ) but was significantly decreased 48 hours ( P = 0.002 ) and 72 hours ( P = 0.001 ) after the surgery in the U group .
-RESULTS	TBil and DBil were significantly increased 48 hours ( P = 0.012 , P = 0.000 ) and 72 hours ( P = 0.000 , P = 0.000 ) after the surgery in C group , while only that at 48 hours ( P = 0.010 , P = 0.038 ) was significantly increased in the U group .
-RESULTS	ALT 4 hours ( P = 0.026 ) , 48 hours ( P = 0.013 ) , 72 hours ( P = 0.004 ) after the surgery were significantly lower in the U group than those in C group .
-RESULTS	TBil at the 72 hours postoperatively in U group was significantly lower than that in C group ( P = 0.036 ) .
-RESULTS	DBil was not significantly different between C group and U group at all time points ( all P > 0.05 ) .
-CONCLUSIONS	The application of ulinastatin in bilateral TKA can protect postoperative liver function .
-
-###24493478
-BACKGROUND	Chinese monogamous women may contract sexually transmitted diseases ( STD ) from their sole male sex partner , but these women do not have high self-efficacy in negotiating about condom use with their regular sex partners .
-OBJECTIVE	We aim to investigate the relative efficacy of a theory-based and clinic-based cognitive behavioral intervention versus a control intervention in increasing prevalence of condom use with their male sex partner among Chinese monogamous female sexually transmitted disease patients .
-METHODS	A randomized controlled trial ( RCT ) was conducted .
-METHODS	Participants were randomly allocated into the intervention group ( n = 88 ) or the control group ( n = 88 ) .
-METHODS	All participants were phone interviewed at baseline and at 2 and 3 months after completion of the baseline survey .
-METHODS	The three-session group intervention was based on the information-motivation-behavioral skills ( IMB ) model .
-METHODS	Participants of the control group were provided with educational pamphlets .
-METHODS	The primary outcome was consistent condom use in the last month .
-METHODS	Relative risks were calculated , and multiple logistic regression models were fit .
-RESULTS	As compared to the control group , the intervention group reported higher prevalence of consistent condom use with the sole male sex partner in the last month at month 2 ( 75.3 versus 59.8 % , RR = 1.26 , 95 % CI = 1.01 , 1.57 ) and month 3 ( 77.8 versus 54.6 % , RR = 1.42 , 95 % CI = 1.13 , 1.80 ) , whilst the baseline between-group difference was statistically non-significant .
-RESULTS	Some other secondary outcomes such as `` intention to request condom use in the next month even if the sexual partner dislikes using condoms '' were also statistically significant .
-RESULTS	Furthermore , the majority ( 94 % ) of the intervention group members were satisfied with the intervention .
-CONCLUSIONS	The theory-based intervention is potentially efficacious , but the follow-up period was relatively short .
-CONCLUSIONS	Large-scale randomized clinical trials and subsequent translational research are greatly warranted in the future .
-
-###24977700
-OBJECTIVE	This study aimed to examine the acute effect of caffeine on exercise capacity , exercise-related fatigue , and functional performance in prostate cancer survivors .
-METHODS	In this randomized , placebo-controlled , double-blind crossover study , 30 prostate cancer survivors ( age , 70.3 7.7 yr ; body mass , 80.5 13.0 kg ; mean SD ) consumed 6.04 0.16 mgkg ( -1 ) of anhydrous caffeine or a placebo 1 h before completing a battery of exercise capacity and functional performance tests .
-METHODS	Testing sessions were separated by 3-4 wk .
-METHODS	Immediate fatigue and perceived exertion were measured directly pre - and postexercise at both testing sessions .
-RESULTS	Caffeine increased exercise capacity by 7.93 s ( +3.0 % ; P = 0.010 ) ; however , postexercise fatigue and perception of exertion were comparable with the placebo session ( P = 0.632 and P = 0.902 , respectively ) .
-RESULTS	Increases in isometric grip strength trended toward significance in both dominant ( +2.9 % ; P = 0.053 ) and nondominant ( +2.1 % ; P = 0.061 ) hands in the caffeine trial compared with placebo .
-RESULTS	Caffeine ingestion did not result in improvements in performance for any of the remaining functional measures , including the timed up-and-go test , repeated chair stands , 6-m fast walk , and 6-m backward tandem walk .
-RESULTS	Systolic blood pressure and HR were significantly increased ( P = 0.006 and P = 0.040 , respectively ) upon completion of the testing battery when compared with placebo .
-CONCLUSIONS	Consumption of caffeine 1 h before exercise induced improvements in exercise capacity and muscular strength in prostate cancer survivors .
-CONCLUSIONS	However , there was no change in exercise-related fatigue when compared with placebo despite reduction in timed performance of the 400-m walk .
-CONCLUSIONS	Caffeine seems to enhance exercise tolerance through improved performance with no subsequent increase in fatigue or perception of exertion and may be an appropriate strategy to promote exercise participation in prostate cancer survivors .
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-###26234945
-OBJECTIVE	To determine whether initiation of cholinesterase inhibitors is associated with significant weight loss in a real-word clinical setting .
-METHODS	Retrospective cohort study from 2007 to 2010 comparing weight loss in individuals with dementia newly prescribed cholinesterase inhibitors and those newly prescribed other chronic medications .
-METHODS	National Veterans Affairs data .
-METHODS	Individuals aged 65 and older with a diagnosis of dementia who received a new prescription for a cholinesterase inhibitor or other new chronic medication .
-METHODS	The primary outcome was time to 10-pound weight loss over 12 months .
-METHODS	Propensity score matching was used to control for the likelihood of receiving a cholinesterase inhibitor based on baseline characteristics .
-METHODS	Data were analyzed in a priori defined subgroups according to age , comorbid burden , and initial weight .
-RESULTS	Of 6,504 individuals that met study criteria , 1,188 started on cholinesterase inhibitors were matched to 2,189 started on other medications .
-RESULTS	The propensity-matched cohorts were well balanced on baseline covariates .
-RESULTS	Participants initiated on cholinesterase inhibitors had a higher risk of weight loss than matched controls at 12 months ( hazard ratio = 1.23 , 95 % confidence interval ( CI ) = 1.07-1 .41 ) .
-RESULTS	At 12 months , 29.3 % of participants taking cholinesterase inhibitors had experienced weight loss , compared with 22.8 % of nonusers , corresponding to a number needed to harm of 21.2 ( 95 % CI = 12.5-71 .4 ) over 1 year .
-RESULTS	There were no significant differences in the risk of weight loss within subgroups .
-CONCLUSIONS	These results are consistent with the available data from randomized controlled trials .
-CONCLUSIONS	Clinicians should consider the risk of weight loss when prescribing cholinesterase inhibitors .
-
-###25107879
-OBJECTIVE	To evaluate whether the calcitonin gene-related peptide ( CGRP ) receptor antagonist telcagepant might be effective for migraine prevention .
-METHODS	In this randomized , double-blind , placebo-controlled , multicenter trial ( ClinicalTrials.gov NCT00797667 ) , patients experiencing 3-14 migraine days during a 4-week baseline were randomized to telcagepant 140 mg , telcagepant 280 mg , or placebo twice daily for 12 weeks .
-METHODS	Efficacy was assessed by mean monthly headache days and migraine/probable migraine days ( headache plus 1 associated symptom ) .
-RESULTS	The trial was terminated following a recommendation from the Safety Monitoring Board due to hepatotoxicity concerns .
-RESULTS	At termination , the planned 660 patients had been randomized , 656 had been treated with 1 dose of study medication , and 14 had completed the trial .
-RESULTS	The mean treatment duration was 48-50 days .
-RESULTS	Thirteen patients , all in the telcagepant groups , had an alanine aminotransferase ( ALT ) elevation 3 the upper limit of normal and 7 of these also had an aspartate aminotransferase elevation 3 the upper limit of normal .
-RESULTS	Two patients had very high symptomatic transaminase elevations that occurred within 2-6 weeks of treatment initiation and resolved after treatment discontinuation .
-RESULTS	The originally planned efficacy analysis over 12 weeks was not performed due to limited data at later time points , but there was evidence that telcagepant resulted in a larger reduction from baseline than placebo for mean monthly headache days ( month 1 : 140 mg = -2.9 , 280 mg = -3.1 , placebo = -1.7 ; p < 0.05 ) and migraine/probable migraine days ( month 1 : 140 mg = -2.7 , 280 mg = -3.0 , placebo = -1.6 ; p < 0.05 ) .
-CONCLUSIONS	These data suggest a potential role for CGRP receptor antagonism in migraine prophylaxis .
-CONCLUSIONS	However , the observed aminotransferase elevations do not support the use of telcagepant for daily administration .
-METHODS	This study provides Class II evidence that in patients with migraine , telcagepant taken daily reduces headache days by 1.4 days per month compared to placebo and causes 2.5 % of patients to have elevations of serum ALT levels .
-
-###25026884
-BACKGROUND	Healthcare professionals play a critical role in women 's choice of contraceptive methods .
-BACKGROUND	However , national surveys on sexual and reproductive health ( SRH ) among physicians are rare and present low participation rates .
-BACKGROUND	We conducted a randomized trial to test for the effectiveness of three interventions to improve survey participation of private physicians delivering reproductive health services in France .
-METHODS	The study comprised a national random sample of 500 general practitioners and 500 gynecologists working in private offices .
-METHODS	All received a postal invitation to participate either by completing a paper , phone or online questionnaire .
-METHODS	Physicians were randomly assigned to six groups to test for the effect of three interventions : a non-monetary incentive in the form of a scientific book , telephone contact , and the possibility of completing the questionnaire by phone .
-RESULTS	Overall , 362 questionnaires were collected ( 26 online , 2 by phone ) and 58 physicians were ineligible .
-RESULTS	The completion rate increased from 26.7 % in physicians who received no intervention to 42.7 % in those who received the book and a phone call .
-RESULTS	The phone call increased the completion rate by 11 % percentage points ( P = 0.01 ) , while the book had no significant effect .
-RESULTS	Results from multivariate logistic regressions also indicate that gynecologists ( OR = 1.6 ) and female physicians ( OR = 1.5 ) were more likely to participate than others .
-CONCLUSIONS	The results suggest that phone calls substantially increase participation of physicians in sexual and reproductive health surveys but have little impact on sampling distortion .
-CONCLUSIONS	Differentials in response rates by physicians ' characteristics should be considered in future SRH studies among physicians .
-
-###24827808
-BACKGROUND	Allogeneic stem-cell transplantation has had limited success for patients with refractory and relapsed aggressive B-cell or T-cell lymphoma .
-BACKGROUND	We investigated the effect of adding rituximab to standard prophylaxis for graft-versus-host disease after transplantation and estimated overall survival when using a lymphoma-directed myeloablative conditioning regimen .
-METHODS	We did this randomised , open-label , phase 2 study at seven German transplantation centres .
-METHODS	We enrolled patients with aggressive B-cell or T-cell lymphoma and primary refractory disease , early relapse ( < 12 months after first-line treatment ) , or relapse after autologous transplantation .
-METHODS	Conditioning with fludarabine ( 125 mg/m ( 2 ) ) , busulfan ( 12 mg/kg oral or 96 mg/kg intravenous ) , and cyclophosphamide ( 120 mg/kg ) was followed by allogeneic stem-cell transplantation .
-METHODS	Patients were randomly assigned ( 1:1 ) to receive rituximab ( 375 mg/m ( 2 ) on days 21 , 28 , 35 , 42 , 175 , 182 , 189 , and 196 ) or not .
-METHODS	Allocation was done with a centralised computer-generated procedure ; patients were stratified by histological subtype ( B-cell vs T-cell lymphoma ) and donor match ( HLA-identical vs non-identical ) .
-METHODS	Neither investigators nor patients were masked to allocation .
-METHODS	The primary endpoints were the incidence of acute graft-versus-host disease grade 2-4 in each treatment group and overall survival at 1 year in both groups combined .
-METHODS	All analyses were done for the intention-to-treat population .
-METHODS	The study is registered with ClinicalTrials.gov , number NCT00785330 .
-RESULTS	Between June 16 , 2004 , and March 24 , 2009 , we screened 86 patients and enrolled 84 ; 42 were randomly assigned to each group .
-RESULTS	The cumulative incidence of grade 2-4 acute graft-versus-host disease was 46 % ( 95 % CI 32-62 ) in the rituximab group and 42 % ( 95 % CI 29-59 ) in the no rituximab group ( hazard ratio [ HR ] 091 , 95 % CI 052-160 ; p = 074 ) .
-RESULTS	Overall survival at 1 year for the whole study population was 52 % ( 95 % CI 41-62 ) .
-RESULTS	Grade 4 haematological toxic effects and grade 3 alopecia occurred in all patients .
-RESULTS	The most common non-haematological grade 5 toxic effects were pneumonia ( nine in the no rituximab group vs ten in the rituximab group ) and other infections ( seven vs four ) .
-CONCLUSIONS	The lymphoma-directed myeloablative conditioning regimen developed here is promising for patients with refractory and relapsed aggressive B-cell and T-cell lymphomas .
-CONCLUSIONS	However , the addition of rituximab did not affect the incidence of graft-versus-host disease or overall survival .
-BACKGROUND	Hoffmann-La Roche , Amgen , Astellas Pharma .
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-###24473592
-OBJECTIVE	This study , based on Oklahoma 's statewide Child Development Accounts ( CDAs ) program , presents findings from the first experimental test of the hypothesis that creating lifelong savings accounts for children at birth promotes their long-term well-being .
-OBJECTIVE	To examine the effects of CDAs , an innovative social policy to encourage lifelong saving and asset building for long-term development , on parent-reported social-emotional development in early childhood .
-METHODS	A statewide randomized experiment of CDAs was conducted in 2008 , drawing a probability sample of 7328 children from all infants born in two 3-month periods in Oklahoma ( April 1 through June 30 and August 1 through October 31 , 2007 ) .
-METHODS	After agreeing to participate in the experiment , caregivers of 2704 infants completed a baseline survey and were randomly assigned to treatment ( n = 1358 ) and control groups ( n = 1346 ) .
-METHODS	Approximately 84 % of participants completed a follow-up survey in the spring of 2011 .
-METHODS	The intervention offered CDAs , built on the existing Oklahoma 529 college-savings plan , to treatment participants .
-METHODS	It also provided additional financial incentives and information .
-METHODS	The primary outcome-child social-emotional development-is measured by scores from a 17-item version of the Ages and Stages Questionnaire : Social-Emotional .
-METHODS	Caregivers completed it in the 3-year follow-up survey .
-METHODS	Lower scores indicate better functioning .
-RESULTS	The CDAs have positive effects on social-emotional development for children at approximately age 4 years .
-RESULTS	The nonweighted treatment-control difference is -1.56 ( 90 % CI , -2.87 to -0.22 ; P = .06 ) , but the weighted difference is nonsignificant .
-RESULTS	The effects appear to be greater for disadvantaged subsamples , such as low-income households ( weighted mean difference,-2 .21 ; 90 % CI , -4.01 to -0.42 ; P = .04 ) .
-CONCLUSIONS	As a complement to other early education and health interventions , CDAs may improve social-emotional development in early childhood .
-CONCLUSIONS	Their effects may be explained as a mediating process that influences parents .
-CONCLUSIONS	Child Development Accounts may influence parental attitudes , behaviors , expectations , and involvement ; in turn , these may affect child development .
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-###25195169
-BACKGROUND	Asthma with neutrophil predominance is challenging to treat with corticosteroids .
-BACKGROUND	Novel treatment options for asthma include those that target innate immune activity .
-BACKGROUND	Recent literature has indicated a significant role for IL-1 in both acute and chronic neutrophilic asthma .
-OBJECTIVE	This study used inhaled endotoxin ( LPS ) challenge as a model of innate immune activation to ( 1 ) assess the safety of the IL-1 receptor antagonist anakinra in conjunction with inhaled LPS and ( 2 ) to test the hypothesis that IL-1 blockade will suppress the acute neutrophil response to challenge with inhaled LPS .
-METHODS	In a phase I clinical study 17 healthy volunteers completed a double-blind , placebo-controlled crossover study in which they received 2 daily subcutaneous doses of 1 mg/kg anakinra ( maximum dose , 100 mg ) or saline ( placebo ) .
-METHODS	One hour after the second treatment dose , subjects underwent an inhaled LPS challenge .
-METHODS	Induced sputum was assessed for neutrophils 4 hours after inhaled LPS .
-METHODS	The effect of anakinra compared with placebo on airway neutrophil counts and airway proinflammatory cytokine levels after LPS challenge was compared by using a linear mixed-model approach .
-RESULTS	Anakinra pretreatment significantly diminished airway neutrophilia compared with placebo .
-RESULTS	LPS-induced IL-1 , IL-6 , and IL-8 levels were significantly reduced during the anakinra treatment period compared with those seen after placebo .
-RESULTS	Subjects tolerated the anakinra treatment well without an increased frequency of infections attributable to anakinra treatment .
-CONCLUSIONS	Anakinra effectively reduced airway neutrophilic inflammation and resulted in no serious adverse events in a model of inhaled LPS challenge .
-CONCLUSIONS	Anakinra is a potential therapeutic candidate for treatment of asthma with neutrophil predominance in diseased populations .
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-###24391022
-OBJECTIVE	To validate a magnetic resonance imaging sequence suitable for quantitative assessment of acid suppression by a proton pump inhibitor ( PPI ) on gastric secretion and emptying in clinical practice .
-METHODS	A golden angle radial sequence ( GOLD ) was validated in a series of in vitro and in vivo experiments and clinical feasibility was shown in two studies .
-METHODS	The impact of free breathing and image plane orientation on T1 values was evaluated in a controlled in vivo experiment .
-METHODS	The free-breathing GOLD sequence was compared against a standard breath-hold gradient echo sequence for gastric half emptying time in 23 subjects during a gastric emptying study .
-METHODS	Pilot data from five subjects assessed the sensitivity of the GOLD sequence to detect changes in acid secretion volume produced by PPI treatment .
-RESULTS	The coronal free-breathing GOLD sequence and the axial breath-hold standard gradient echo sequence showed good agreement of the gastric half emptying time ( 6 3 min , P = 0.053 ) .
-RESULTS	The GOLD sequence demonstrated sensitivity to reduction of gastric secretion volumes induced by PPI treatment ( 55 5 mL , P < 0.001 ) .
-CONCLUSIONS	The GOLD sequence allowed for free breathing , multislice , combined imaging and T1 mapping of the stomach content .
-CONCLUSIONS	GOLD presents a promising multipurpose , noninvasive imaging tool for monitoring gastric function in clinical studies .
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-###25223378
-BACKGROUND	In spite of several studies , the impact of homocysteine level and folic acid supplementation on bone metabolism is yet to be recognized .
-BACKGROUND	In this registered clinical trial ( IRCT2014042217385N1 ) , we aimed to find out the power of 6-month folic acid supplementation on homocysteine level and bone metabolism .
-METHODS	Forty postmenopausal osteoporotic women ( 50 to 87years ) were enrolled in the study .
-METHODS	All participants were randomized to receive folic acid 1mg ( n = 17 ) or placebo ( n = 14 ) .
-METHODS	At baseline , 3months , and finally 6months post intervention , the level of homocysteine , vitamin B12 , and bone biomarkers were measured .
-RESULTS	Both groups were similar at baseline .
-RESULTS	The homocysteine decreased in both groups but statistically non-significant ( P > 0.05 ) .
-RESULTS	The changes of the serum level of vitamin B12 , osteocalcin , and cross laps were significant between groups after 6months ( P0 .05 ) .
-CONCLUSIONS	The trend of changes of bone biomarkers after 6months folic acid supplementation shows that homocysteine concentration and/or folic acid supplementation have impact on the rate of bone metabolism .
-CONCLUSIONS	However , further investigations by larger sample size and differentiating age and gender are still needed to clarify the exact role of folate , homocysteine and vitamin B12 .
-
-###25261629
-BACKGROUND	Theta-burst transcranial magnetic stimulation ( TBS ) has been shown to induce potent and long lasting effects on cortical excitability .
-BACKGROUND	In a previous open study , we demonstrated safety , tolerability and antidepressant properties of continuous TBS ( cTBS ) in major depression ( MD ) .
-BACKGROUND	The present study was aimed to evaluate the therapeutic efficacy of cTBS in depressed patients using a double-blind , sham-controlled design .
-METHODS	Twenty nine patients with MD were randomized to receive either active cTBS to the right dorsolateral prefrontal cortex ( n = 15 ) or sham cTBS ( n = 14 ) for 10 consecutive work days .
-METHODS	After the 10th session , patients who received sham TBS were crossed over to active cTBS which consisted of 10 daily sessions .
-METHODS	Patients who received active cTBS continued with the same treatment protocol for additional 10 treatments .
-METHODS	Each treatment session consisted of 3600 stimuli at an intensity of 100 % of the active motor threshold .
-METHODS	Severity of depression was assessed weekly .
-RESULTS	Overall , there was no significant difference in the degree of clinical improvement between active and sham cTBS groups .
-RESULTS	However , in patients whose medication status remained unchanged before the trial ( n = 8 ) and in those who were medication-free ( n = 3 ) , active cTBS resulted in a significantly greater reduction of Hamilton depression scores as compared to sham cTBS .
-CONCLUSIONS	A small sample size , confounding effect of medication and short treatment period .
-CONCLUSIONS	Our results suggest that the antidepressant effect of cTBS is modest , yet it might be beneficial to patients nonresponsive to ongoing pharmacological treatment .
-CONCLUSIONS	A direct comparison between cTBS and conventional rTMS protocols is warranted .
-
-###25588590
-OBJECTIVE	To study the effects of continuous ultrasonic phacoemulsification performed with and without an anterior chamber maintainer ( ACM ) on corneal endothelial damage in patients with hard nuclear cataract .
-METHODS	Sixty eyes in 60 patients with hard nuclear cataract ( grade IV ) , one lesion per eye , were randomly allocated into 2 groups : continuous ultrasonic phacoemulsification with ( group A ) or without ( group B ) ACM .
-METHODS	The intraoperative accumulated energy complex parameter ( AECP ) , frequency of shallow anterior chamber , and postoperative corneal incision edema , corneal endothelial cell counts , and visual recovery were compared between the groups .
-RESULTS	The intraoperative AECP , postoperative corneal incision edema , and postoperative visual recovery showed no significant differences between the groups ( p > 0.05 ) .
-RESULTS	At 1 month postoperatively , the corneal endothelial cell loss rate and hexagonal cell percentage ( postoperative compared to preoperative ) in groups A and B were 0.117 0.12 and 9.97 9.52 % and 0.15 0.73 and 8.5 4.60 % , respectively , with no significant difference noted ( p > 0.05 ) .
-RESULTS	The endothelial cell mutation rate was significantly lower in group A than in group B at 6.41 6.78 % and 28.27 27.95 % , respectively ( p < 0.05 ) .
-RESULTS	The frequency of intraoperative shallow anterior chamber was significantly lower in group A than in group B ( 2 vs 17 times , p < 0.05 ) .
-CONCLUSIONS	Continuous ultrasonic phacoemulsification with ACM is a safe , effective , simple , and easy method to treat hard nuclear cataract and causes minimal damage to corneal endothelial cells .
-CONCLUSIONS	It is an ideal surgical option and is worth popularizing .
-
-###25667258
-BACKGROUND	Shorter resident duty periods are increasingly mandated to improve patient safety and physician well-being .
-BACKGROUND	However , increases in continuity-related errors may counteract the purported benefits of reducing fatigue .
-BACKGROUND	We evaluated the effects of 3 resident schedules in the intensive care unit ( ICU ) on patient safety , resident well-being and continuity of care .
-METHODS	Residents in 2 university-affiliated ICUs were randomly assigned ( in 2-month rotation-blocks from January to June 2009 ) to in-house overnight schedules of 24 , 16 or 12 hours .
-METHODS	The primary patient outcome was adverse events .
-METHODS	The primary resident outcome was sleepiness , measured by the 7-point Stanford Sleepiness Scale .
-METHODS	Secondary outcomes were patient deaths , preventable adverse events , and residents ' physical symptoms and burnout .
-METHODS	Continuity of care and perceptions of ICU staff were also assessed .
-RESULTS	We evaluated 47 ( 96 % ) of 49 residents , all 971 admissions , 5894 patient-days and 452 staff surveys .
-RESULTS	We found no effect of schedule ( 24 - , 16 - or 12-h shifts ) on adverse events ( 81.3 , 76.3 and 78.2 events per 1000 patient-days , respectively ; p = 0.7 ) or on residents ' sleepiness in the daytime ( mean rating 2.33 , 2.61 and 2.30 , respectively ; p = 0.3 ) or at night ( mean rating 3.06 , 2.73 and 2.42 , respectively ; p = 0.2 ) .
-RESULTS	Seven of 8 preventable adverse events occurred with the 12-hour schedule ( p = 0.1 ) .
-RESULTS	Mortality rates were similar for the 3 schedules .
-RESULTS	Residents ' somatic symptoms were more severe and more frequent with the 24-hour schedule ( p = 0.04 ) ; however , burnout was similar across the groups .
-RESULTS	ICU staff rated residents ' knowledge and decision-making worst with the 16-hour schedule .
-CONCLUSIONS	Our findings do not support the purported advantages of shorter duty schedules .
-CONCLUSIONS	They also highlight the trade-offs between residents ' symptoms and multiple secondary measures of patient safety .
-CONCLUSIONS	Further delineation of this emerging signal is required before widespread system change .
-BACKGROUND	ClinicalTrials.gov , no .
-BACKGROUND	NCT00679809 .
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-###25172965
-OBJECTIVE	Postpericardiotomy syndrome , postoperative atrial fibrillation ( AF ) , and postoperative effusions may be responsible for increased morbidity and health care costs after cardiac surgery .
-OBJECTIVE	Postoperative use of colchicine prevented these complications in a single trial .
-OBJECTIVE	To determine the efficacy and safety of perioperative use of oral colchicine in reducing postpericardiotomy syndrome , postoperative AF , and postoperative pericardial or pleural effusions .
-METHODS	Investigator-initiated , double-blind , placebo-controlled , randomized clinical trial among 360 consecutive candidates for cardiac surgery enrolled in 11 Italian centers between March 2012 and March 2014 .
-METHODS	At enrollment , mean age of the trial participants was 67.5 years ( SD , 10.6 years ) , 69 % were men , and 36 % had planned valvular surgery .
-METHODS	Main exclusion criteria were absence of sinus rhythm at enrollment , cardiac transplantation , and contraindications to colchicine .
-METHODS	Patients were randomized to receive placebo ( n = 180 ) or colchicine ( 0.5 mg twice daily in patients 70 kg or 0.5 mg once daily in patients < 70 kg ; n = 180 ) starting between 48 and 72 hours before surgery and continued for 1 month after surgery .
-METHODS	Occurrence of postpericardiotomy syndrome within 3 months ; main secondary study end points were postoperative AF and pericardial or pleural effusion .
-RESULTS	The primary end point of postpericardiotomy syndrome occurred in 35 patients ( 19.4 % ) assigned to colchicine and in 53 ( 29.4 % ) assigned to placebo ( absolute difference , 10.0 % ; 95 % CI , 1.1 % -18.7 % ; number needed to treat = 10 ) .
-RESULTS	There were no significant differences between the colchicine and placebo groups for the secondary end points of postoperative AF ( colchicine , 61 patients [ 33.9 % ] ; placebo , 75 patients [ 41.7 % ] ; absolute difference , 7.8 % ; 95 % CI , -2.2 % to 17.6 % ) or postoperative pericardial/pleural effusion ( colchicine , 103 patients [ 57.2 % ] ; placebo , 106 patients [ 58.9 % ] ; absolute difference , 1.7 % ; 95 % CI , -8.5 % to 11.7 % ) , although there was a reduction in postoperative AF in the prespecified on-treatment analysis ( placebo , 61/148 patients [ 41.2 % ] ; colchicine , 38/141 patients [ 27.0 % ] ; absolute difference , 14.2 % ; 95 % CI , 3.3 % -24.7 % ) .
-RESULTS	Adverse events occurred in 21 patients ( 11.7 % ) in the placebo group vs 36 ( 20.0 % ) in the colchicine group ( absolute difference , 8.3 % ; 95 % CI ; 0.76 % -15.9 % ; number needed to harm = 12 ) , but discontinuation rates were similar .
-RESULTS	No serious adverse events were observed .
-CONCLUSIONS	Among patients undergoing cardiac surgery , perioperative use of colchicine compared with placebo reduced the incidence of postpericardiotomy syndrome but not of postoperative AF or postoperative pericardial/pleural effusion .
-CONCLUSIONS	The increased risk of gastrointestinal adverse effects reduced the potential benefits of colchicine in this setting .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01552187 .
-
-###25159623
-OBJECTIVE	It is uncertain whether HIV-1 antiretroviral exposure and clinical response varies between males and females or different race/ethnic groups .
-OBJECTIVE	We describe ritonavir-enhanced atazanavir pharmacokinetics in relation to virological failure , safety and tolerability in treatment-naive individuals to investigate potential differences .
-METHODS	Plasma samples were collected from participants in AIDS Clinical Trials Group Study A5202 for measurement of antiretroviral concentrations .
-METHODS	Individual estimates of apparent oral clearance of atazanavir ( L/h ) were calculated from a one-compartment model and divided into tertiles as slow ( < 7 ) , middle ( 7 to < 9 ; reference group ) and fast ( 9 ) .
-METHODS	Associations between atazanavir clearance and clinical outcomes were estimated with a hazard ratio ( HR ) from Cox proportional hazards models .
-METHODS	Interactions between atazanavir clearance and sex , race/ethnicity and NRTIs were investigated for each of the outcomes .
-RESULTS	Among 786 participants , average atazanavir clearance was slower in females ( n = 131 ) than males ( n = 655 ) .
-RESULTS	Atazanavir clearance was associated with time to virological failure ( P = 0.053 ) and this relationship differed significantly by sex ( P = 0.003 ) .
-RESULTS	Females in the fast atazanavir clearance group had shorter time to virological failure ( HR 3.49 ; 95 % CI 1.24-9 .84 ) compared with the middle ( reference ) atazanavir clearance group .
-RESULTS	Among males , the slow atazanavir clearance group had a higher risk of virological failure ( HR 2.10 ; 95 % CI 1.16-3 .77 ) .
-CONCLUSIONS	Atazanavir clearance differed by sex .
-CONCLUSIONS	Females with fast clearance and males with slow clearance had increased risk of virological failure .
-
-###24523436
-BACKGROUND	Transthoracic oesophagectomy requires prolonged one-lung ventilation causing systemic and local inflammatory responses .
-BACKGROUND	Application of continuous positive airway pressure ( CPAP ) to the collapsed lung potentially reduces pulmonary damage , hypoxia , and consequent inflammation .
-BACKGROUND	This randomized controlled trial studied the influence of CPAP applied to the collapsed right lung during thoracoscopic oesophagectomy on local and systemic inflammatory response .
-METHODS	Broncho-alveolar lavage fluid ( BALF ) from the right collapsed and left ventilated lung and serum samples were obtained during surgery from 30 patients undergoing thoracolaparoscopic oesophagectomy for cancer who were randomized for one-lung ventilation with or without CPAP applied to the collapsed right lung .
-METHODS	Concentrations of cytokines and chemokines , in BALF and serum , were determined with Luminex .
-RESULTS	Patients from the control ( no CPAP ) group had significantly increased concentrations of interleukin ( IL ) -1 , IL-1 , IL-10 , tumour necrosis factor-alpha , macrophage inflammatory protein ( MIP ) -1 , pulmonary and activation-regulated chemokine ( PARC ) , and IL-8 in the collapsed ( right ) lung when compared with patients from the CPAP group ( P < 0.05 ) .
-RESULTS	The ventilated ( left ) lung of the control group showed increased concentrations of monocyte chemoattractant protein ( MCP ) -1 and MIP-1 ( P < 0.05 ) .
-RESULTS	Serum concentrations of cytokines and chemokines increased during surgery , but did not differ between the control and CPAP groups .
-CONCLUSIONS	A significantly lower local immune response was observed during one-lung ventilation when CPAP was applied to the collapsed lung .
-CONCLUSIONS	The findings suggest a beneficial effect of CPAP on the collapsed lung during oesophagectomy with one-lung ventilation .
-
-###24829952
-OBJECTIVE	To identify the factors underlying prostate cancer ( PCa ) patients ' depression-anxiety , sexual problems , urinary dysfunction and androgen deprivation therapy ( ADT ) - linked breast changes and hot flushes , and test these as predictors of loss of masculinity ( LoM ) over 36 months following diagnosis .
-METHODS	One thousand seventy patients from the TROG 03.04 ( RADAR ) trial the EORTC QLQ C-30 and PR 25 questionnaires , and the International Prostate Cancer Symptom Score of the American Urological Association at baseline , 3 , 7 , 12 , 18 , 24 and 36 months .
-METHODS	Selected items from these scales were factor-analysed to identify a four-component solution for responses at 18 and 36 months , and these components were regressed against a single-item measuring LoM .
-RESULTS	Depression-anxiety factor was the most powerful predictor of LoM at both time points , followed by sexual problems of ADT side effects ( breast changes and hot flushes ) .
-RESULTS	Urinary dysfunction was not a consistent predictor of LoM .
-RESULTS	Depression-anxiety was also the most significant factor distinguishing between those men who reported LoM and those who did not .
-CONCLUSIONS	Although LoM is often reported as arising from ADT , the relative power of depression-anxiety in predicting LoM , both at the selected time points and using a time-lagged analysis , plus the finding that depression-anxiety was the most consistent difference between men who reported LoM and those who did not , argues for the presence of adverse mood states as being the key ingredient in deciding if PCa patients experience loss of their feelings of masculinity .
-
-###24922664
-BACKGROUND	The insulin-like growth factor 1 receptor ( IGF1R ) has yet to be established as a biomarker in non-small cell lung cancer ( NSCLC ) but could prove useful in customized chemotherapy .
-BACKGROUND	We explored its prognostic value using both quantitative real-time reverse transcriptase polymerase chain reaction ( qRT-PCR ) and immunohistochemistry ( IHC ) .
-METHODS	Analyses of IGF1R were performed on patients with advanced NSCLC , included in a randomized chemotherapy trial , having large , representative tissue samples .
-METHODS	IGF1R mRNA and protein expression were correlated to clinical end-points .
-RESULTS	Surgical tissue samples were available from 33 patients deemed inoperable .
-RESULTS	IGF1R status varied according to histopathology .
-RESULTS	Patients with tumors positive for IGF1R mRNA expression had a shorter progression-free and overall survival when compared to the negative sub-group ( 6.1 vs. 7.4 months , p = 0.039 and 10.9 vs. 14.3 months , p = 0.038 , respectively ) .
-RESULTS	IGF1R protein expression showed a similar , although non-significant tendency .
-CONCLUSIONS	IGF1R mRNA expression may be a prognostic biomarker in advanced NSCLC and should be investigated in a larger population .
-
-###24918330
-BACKGROUND	The ideal spread of local anesthetic for effective , rapid , and safe sciatic nerve block is debated .
-BACKGROUND	We hypothesized that subparaneural ultrasound-guided injection results in faster onset and has a better success rate than extraneural circumferential spread .
-METHODS	Patients undergoing elective tibial , foot , and ankle surgery with popliteal sciatic nerve blocks were prospectively enrolled .
-METHODS	After randomization , the needle tip position was adjusted to ensure circumferential extraneural or subparaneural spread ; 0.3 mL/kg of mepivacaine 10 mg/mL was injected .
-METHODS	Post hoc video analysis was used to group the patients according to extraneural , subparaneural , and unintentional intraepineural spread .
-RESULTS	There were 26 ( 43.3 % ) patients in the subparaneural group and 22 ( 36.7 % ) in the extraneural group .
-RESULTS	Block onset time was shorter in the subparaneural group than in the extraneural group ( 11 [ 3-21 ] minutes ; mean [ 95 % confidence interval ] , 11 [ 8.97-13 .02 ] minutes and 17 [ 6-30 ] minutes ; mean [ 95 % confidence interval ] 18.37 [ 14.17-22 .57 ] minutes , respectively ; P = 0.002 ) .
-RESULTS	The duration of sensory blockade increased ( 397 [ 178-505 ] minutes vs 265 [ 113-525 ] minutes ; P = 0.04 ) .
-RESULTS	The success rate of the block also increased .
-RESULTS	Unintentional intraepineural injection occurred in 8 % of patients ( 3 patients in the subparaneural group and 1 patient in the extraneural group ; NS ) .
-RESULTS	Block onset time was shorter than for the subparaneural and extraneural groups ( 6 [ 3-12 ] minutes , 12 [ 3-21 ] minutes , and 18 [ 6-30 ] minutes ; P = 0.01 ) .
-CONCLUSIONS	A subparaneural injection accelerated the onset time and increased the duration of tibial nerve sensory blockade compared with circumferential extraneural injection .
-CONCLUSIONS	With unintentional intraepineural spread , the onset time was significantly shorter than for the other groups .
-
-###24593273
-BACKGROUND	The optimal agents and duration of primary antifungal prophylaxis in recipients of allogeneic hematopoietic stem cell transplantation ( allo-HSCT ) remain a matter of discussion .
-OBJECTIVE	Our objective was to compare the efficacy and safety of long-term and short-term administration of itraconazole ( ITCZ ) for primary antifungal prophylaxis in allo-HSCT recipients .
-METHODS	This multicenter , randomized , open-label pilot study was performed in 4 transplant centers in China .
-METHODS	Recipients of allo-HSCT without a history of invasive fungal disease ( IFD ) were randomly assigned to the long-term or the short-term arm .
-METHODS	Randomization was carried out by a center computer system .
-METHODS	Intravenous ITCZ was given to the patients in both study arms with a loading dose of 400 mg/day for 2 days followed by 200 mg/day until day +14 or when the white blood cell count was > 1.0 10 ( 9 ) / L , and then switched to oral ITCZ solution ; prophylaxis was continued until day +30 post transplantation in the short-term arm or until day +90 in the long-term arm .
-METHODS	The trough serum concentrations of ITCZ also were measured .
-METHODS	The primary study endpoint was the incidence of IFD ( proven , probable , and possible ) within day +90 post transplantation .
-RESULTS	A total of 128 recipients were enrolled in this study ; 59 of them were randomized to the long-term arm and 62 were randomized to the short-term arm , forming the modified intent-to-treat ( mITT ) set .
-RESULTS	The incidence of IFD within day +90 , the primary endpoint , was not significantly different between the 2 arms for the mITT set ( 6.78 % in the long-term arm vs. 6.45 % in the short-term arm , P = 0.94 ) , or for the per-protocol set ( 6.90 % in the long-term arm vs. 6.67 % in the short-term arm , P = 0.96 ) .
-RESULTS	From day +30 to day +90 , the incidence of IFD was 0 % and 6.45 % , respectively , in the patients with long-term and short-term prophylaxis for the mITT set ( P = 0.11 ) .
-RESULTS	The mean trough serum concentrations of ITCZ was maintained at > 500 ng/mL throughout administration .
-RESULTS	The incidences of withdrawal because of drug-related adverse events in patients with long-term and short-term prophylaxis were 6.78 % and 0 % , respectively ( P = 0.05 ) .
-CONCLUSIONS	Long-term and short-term administration of ITCZ both seemed effective in preventing IFD in recipients of allo-HSCT .
-CONCLUSIONS	Further study with large sample size should be performed to evaluate this result .
-CONCLUSIONS	ITCZ shows the same pharmacokinetics in recipients of allo-HSCT as in non-recipients .
-
-###25713428
-OBJECTIVE	Fixed-dose rate gemcitabine plus docetaxel achieves objective response in 35 % of patients with uterine leiomyosarcoma ( uLMS ) .
-OBJECTIVE	This study aimed to determine whether the addition of bevacizumab to gemcitabine-docetaxel increases progression-free survival ( PFS ) in uLMS .
-METHODS	In this phase III , double-blind , placebo-controlled trial , patients with chemotherapy-naive , metastatic , unresectable uLMS were randomly assigned to gemcitabine-docetaxel plus bevacizumab or gemcitabine-docetaxel plus placebo .
-METHODS	PFS , overall survival ( OS ) , and objective response rates ( ORRs ) were compared to determine superiority .
-METHODS	Target accrual was 130 patients to detect an increase in median PFS from 4 months ( gemcitabine-docetaxel plus placebo ) to 6.7 months ( gemcitabine-docetaxel plus bevacizumab ) .
-METHODS	Treatment effects on PFS and OS were described by hazard ratios ( HRs ) , median times to event , and 95 % CIs .
-RESULTS	In all , 107 patients were accrued : gemcitabine-docetaxel plus placebo ( n = 54 ) and gemcitabine-docetaxel plus bevacizumab ( n = 53 ) .
-RESULTS	Accrual was stopped early for futility .
-RESULTS	No statistically significant differences in grade 3 to 4 toxicities were observed .
-RESULTS	Median PFS was 6.2 months for gemcitabine-docetaxel plus placebo versus 4.2 months for gemcitabine-docetaxel plus bevacizumab ( HR , 1.12 ; P = .58 ) .
-RESULTS	Median OS was 26.9 months for gemcitabine-docetaxel plus placebo and 23.3 months for gemcitabine-docetaxel plus bevacizumab ( HR , 1.07 ; P = .81 ) .
-RESULTS	Objective responses were observed in 17 ( 31.5 % ) of 54 patients randomly assigned to gemcitabine-docetaxel plus placebo and 19 ( 35.8 % ) of 53 patients randomly assigned to gemcitabine-docetaxel plus bevacizumab .
-RESULTS	Mean duration of response was 8.6 months for gemcitabine-docetaxel plus placebo versus 8.8 months for gemcitabine-docetaxel plus bevacizumab .
-CONCLUSIONS	The addition of bevacizumab to gemcitabine-docetaxel for first-line treatment of metastatic uLMS failed to improve PFS , OS , or ORR .
-CONCLUSIONS	Gemcitabine-docetaxel remains a standard first-line treatment for uLMS .
-
-###24531742
-OBJECTIVE	This pilot study aimed to investigate the feasibility of two different training programs in patients with advanced gastrointestinal cancer undergoing palliative chemotherapy .
-OBJECTIVE	Potential effects of training programs on the patients ' quality of life , physical performance , physical activity in daily living , and biological parameters were exploratorily evaluated .
-METHODS	Patients were randomly assigned to a resistance ( RET ) and aerobic exercise training group ( AET ) .
-METHODS	Both underwent supervised training sessions twice a week for 12 weeks .
-METHODS	RET was performed at 60-80 % of the one-repetition maximum and consisted of 2-3 sets of 15-25 repetitions .
-METHODS	The AET group performed endurance training at 60-80 % of their predetermined pulse rate ( for 10 to 30 min ) .
-RESULTS	A total of 26 gastrointestinal cancer patients could be randomized .
-RESULTS	Twenty-one patients completed the 12 weeks of intervention .
-RESULTS	The median adherence rate to exercise training of all 26 patients was 65 % , while in patients who were able to complete 12 weeks , adherence was 75 % .
-RESULTS	The fatigue score of all patients decreased from 66 to 43 post-intervention .
-RESULTS	Sleeping duration increased in both groups and muscular strength increased in the RET group .
-RESULTS	A higher number of steps in daily living was associated with higher levels of physical and social functioning as well as lower scores for pain and fatigue .
-CONCLUSIONS	RET and AET are feasible in gastrointestinal cancer patients undergoing palliative chemotherapy .
-CONCLUSIONS	Both training programs seem to improve cancer-related symptoms as well as the patient 's physical activities of daily living .
-
-###25672333
-OBJECTIVE	The aims of the study were to 1 ) determine the effectiveness of QuikClot Combat Gauze ( QCG ) ; 2 ) determine the arterial blood pressure at which rebleeding occurs ; 3 ) determine how much intravenous fluid could be administered before hemorrhage reoccurred , and 4 ) determine the number extremity movement on rebleeding when QCG was used .
-METHODS	This was a prospective , randomized , experimental study .
-METHODS	Adult Yorkshire pigs were randomly assigned to two groups QCG ( n = 10 ) or control ( n = 10 ) .
-METHODS	After the swine were anesthetized , the investigators transected the femoral artery and vein .
-METHODS	After 1 minute of uncontrolled bleeding , QCG was placed in the wound followed by standard wound packing .
-METHODS	The control group underwent the same procedures without QCG .
-METHODS	After 5 minutes of firm , manual pressure , a pressure dressing was applied .
-METHODS	Following 30 minutes , the dressings were removed and blood loss was calculated .
-METHODS	If hemostasis occurred , phenylephrine was administered until there was rebleeding .
-METHODS	If no bleeding , up to 5 L of IV crystalloid was administered until there was hemorrhage .
-METHODS	If no bleeding , the extremity on the side of the hemorrhage was moved through flexion , extension , abduction , and adduction 10 times or until rebleeding occurred .
-RESULTS	QCG compared to a control was more effective in controlling hemorrhage , withstanding increases in systolic blood pressure , more latitude in resuscitation fluid , and movement ( p < 0.05 ) .
-
-###25538330
-OBJECTIVE	Benign prostatic hyperplasia ( BPH ) is the most common cause of lower urinary tract symptoms in elderly men .
-OBJECTIVE	Selective alfa1-adrenergic antagonists are now first-line drugs in the medical management of BPH .
-OBJECTIVE	We conducted a single-blind , parallel group , randomized , controlled trial to compare the effectiveness and safety of the new alfa1-blocker silodosin versus the established drug tamsulosin in symptomatic BPH .
-METHODS	Ambulatory male BPH patients , aged above 50 years , were recruited on the basis of International Prostate Symptom Score ( IPSS ) .
-METHODS	Subjects were randomized in 1:1 ratio to receive either tamsulosin 0.4 mg controlled release or silodosin 8 mg once daily after dinner for 12 weeks .
-METHODS	Primary outcome measure was reduction in IPSS .
-METHODS	Proportion of subjects who achieved IPSS < 8 , change in prostate size as assessed by ultrasonography and changes in peak urine flow rate and allied uroflowmetry parameters , were secondary effectiveness variables .
-METHODS	Treatment emergent adverse events were recorded .
-RESULTS	Data of 53 subjects - 26 on silodosin and 27 on tamsulosin were analyzed .
-RESULTS	Final IPSS at 12-week was significantly less than baseline for both groups .
-RESULTS	However , groups remained comparable in terms of IPSS at all visits .
-RESULTS	There was a significant impact on sexual function ( assessed by IPSS sexual function score ) in silodosin arm compared with tamsulosin .
-RESULTS	Prostate size and uroflowmetry parameters did not change .
-RESULTS	Both treatments were well-tolerated .
-RESULTS	Retrograde ejaculation was encountered only with silodosin and postural hypotension only with tamsulosin .
-CONCLUSIONS	Silodosin is comparable to tamsulosin in the treatment of BPH in Indian men .
-CONCLUSIONS	However , retrograde ejaculation may be troublesome for sexually active patients .
-
-###25522560
-OBJECTIVE	Invastigation of macrolides in the treatment of drug effects in chronic rhinosinusit .
-METHODS	The 165 patients with chronic rhinosinusit were randomly divided into 80 cases of macrolides drug group and 85 cases of cephalosporins group , and therapeutic effect was observed .
-METHODS	The therapeutic effect of macrolides was also observed in refractory chronic rhinosinusit .
-RESULTS	Comparing macrolides group and cephalosporins group , there is not statistically significant ( P > 0.05 ) .
-RESULTS	Treatment with macrolides cefixime tablet ineffective treatment of patients for 3 months , compared before and after treatment was statistically significant ( P < 0.01 ) .
-RESULTS	Treatment with cefixime tablet macrolides ineffective treatment of patients for 3 months , compared before and after treatment was not statistically significant ( P > 0.05 ) .
-CONCLUSIONS	Long-term low-dose applications of macrolides have a good effect in patients with chronic rhinosinusit , particularly for refractory chronic rhinosinusit have a significant effect .
-
-###24606117
-OBJECTIVE	To assess sublingual asenapine for acute agitation .
-METHODS	Agitated adults 18-65 years ( any diagnosis ) presenting for treatment in an emergency department and found to have a score of 14 on the Positive and Negative Syndrome Scale-Excited Component ( PANSS-EC ) were randomized to receive either a single dose of a sublingual 10 mg tablet of asenapine or placebo .
-METHODS	Primary outcome measure was change in the PANSS-EC score from baseline to 2 h after medication or placebo administration .
-METHODS	Secondary outcomes included the percentage of responders with a 40 % reduction from baseline on the PANSS-EC score at 2 h.
-RESULTS	A total of 120 subjects were randomized , 60 each to sublingual asenapine or placebo .
-RESULTS	Mean ( SE ) baseline PANSS-EC scores for the asenapine-treated and placebo-treated subjects were 19.4 0.66 and 20.1 0.61 , respectively .
-RESULTS	Mean PANSS-EC scores at endpoint ( LOCF ) was 7.4 0.65 for the asenapine-treated subjects and 14.7 0.98 for the placebo-treated subjects .
-RESULTS	Change in PANSS-EC score at 2 h was statistically significantly greater for the asenapine-treated subjects compared with the placebo-treated subjects .
-RESULTS	NNT for response vs. placebo was 3 ( 95 % CI 2-4 ) .
-CONCLUSIONS	Sublingual asenapine was efficacious in the treatment of agitation with an effect size comparable to that observed in prior studies of intramuscular antipsychotics .
-
-###25121620
-OBJECTIVE	The aim of this study was to evaluate the effects of an mHealth intervention ( intervention using mobile technology ) consisting of tailored advice regarding exposure to daylight , sleep , physical activity , and nutrition , and aiming to improve health-related behavior , thereby reducing sleep problems and fatigue and improving health perception of airline pilots .
-METHODS	A randomized controlled trial was conducted among 502 airline pilots .
-METHODS	The intervention group was given access to both the MORE Energy mobile application ( app ) with tailored advice and a website with background information .
-METHODS	The control group was directed to a website with standard information about fatigue .
-METHODS	Health-related behavior , fatigue , sleep , and health perception outcomes were measured through online questionnaires at baseline and at three and six months after baseline .
-METHODS	The effectiveness of the intervention was determined using linear and Poisson mixed model analyses .
-RESULTS	After six months , compared to the control group , the intervention group showed a significant improvement on fatigue ( = -3.76 , P < 0.001 ) , sleep quality ( = -0.59 , P = 0.007 ) , strenuous physical activity ( = 0.17 , P = 0.028 ) , and snacking behavior ( = -0.81 , P < 0.001 ) .
-RESULTS	No significant effects were found for other outcome measures .
-CONCLUSIONS	The MORE Energy mHealth intervention reduced self-reported fatigue compared to a minimal intervention .
-CONCLUSIONS	Some aspects of health-related behavior ( physical activity and snacking behavior ) and sleep ( sleep quality ) improved as well , but most did not .
-CONCLUSIONS	The results show offering tailored advice through an mHealth intervention is an effective means to support employees who have to cope with irregular flight schedules and circadian disruption .
-CONCLUSIONS	This kind of intervention might therefore also be beneficial for other working populations with irregular working hours .
-
-###25911881
-OBJECTIVE	To explore the effect of prophylactic hepatic artery infusion chemotherapy ( HAIC ) on survival probability after curative resection in patients with hepatocellular carcinoma ( HCC ) .
-METHODS	85 patients with HCC were randomly assigned to HAIC group ( 42 cases ) and control group ( 43 patients ) , all the database of two groups had no significant difference .
-METHODS	Patients in HAIC groups underwent hepatic artery infusion chemotherapy ( 5-FU 1000 mg/m2 on day 1 , Oxaliplatin 85 mg/m2 on day 1 and Gemcitabine 1000 mg/m2 on day 1 and 8 ) starting 3 weeks after operation with intervals of 4 weeks .
-METHODS	All patients were followed up for 3 years and intrahepatic recurrence-free survival , disease-free survival rate and overall survival rate were recorded .
-RESULTS	Intrahepatic recurrence rate of HAIC group and the control group was respectively 19.05 % and 39.53 % , P < 0.05 .
-RESULTS	Disease-free survival rate was respectively 57.14 % and 44.19 % , P < 0.05 .
-RESULTS	Overall survival rate was 66.67 % and 46.51 % , P < 0.05 .
-RESULTS	All patients in HAIC group tolerated the therapy .
-RESULTS	No adverse effect above grade 3 was reported in HAIC group .
-CONCLUSIONS	HAIC effectively and safely prevents intrahepatic recurrence and improves the prognosis of patients with HCC after curative resection .
-
-###25709422
-BACKGROUND	Traditional models for delirium based on the Diagnostic and Statistical Manual for Mental Disorders and its 1990 offspring , the Confusion Assessment Method ( CAM ) , were not designed to distinguish behavioral and psychological symptoms of dementia from rapid cognitive decline .
-BACKGROUND	We examined a new diagnostic criterion for delirium plus exclusion of behavioral and psychological symptoms of dementia and recent inattention with a 25 % decline in digit span forward ( DSF ) .
-METHODS	This was a prospective , randomized controlled trial comparing management of prevalent delirium in general medical with that in geriatric medical wards in a 370-bed hospital north of Sydney .
-METHODS	Inclusion criteria were age 65 years and prevalent delirium in the emergency department based on : CAM ; proof that CAM elements were not better explained by behavioral and psychological symptoms of dementia ; proof of recent inattention on DSF ; evidence of cognitive decline not due to sedatives or antipsychotics in the emergency department .
-METHODS	Measurements included the Instrumental Activities of Daily Living ( IADL , 22-item ) , Selective IADL ( 8-item ) , Mini-Mental State Examination , DSF daily , Delirium Index daily , and Apathy Evaluation Scale .
-METHODS	Pre-delirium scores from past cognitive tests and best scores were imputed after admission .
-METHODS	Relative change ( RC ) was calculated as absolute change/test range and RC/MPC ratio was calculated as RC after admission/maximal possible change .
-RESULTS	A total of 130 subjects were recruited but 14 with subsyndromal delirium were excluded , leaving 116 subjects ( mean age 83.6 years ) .
-RESULTS	Forty-eight percent had prior dementia .
-RESULTS	RC from pre-delirium to admission was 42 % for the Mini-Mental State Examination , 41 % for Selective IADL , 34 % for 5-DSF , 54 % for 6-DSF , and 37 % for the Apathy Evaluation Scale .
-RESULTS	Improvements after admission ( RC and RC/MPC ratios ) were 32 % / 98 % for 5-DSF , 54 % / 82 % for 6-DSF , and 45 % / 80 % for the Delirium Index .
-RESULTS	General medicine and geriatric medicine groups had similar outcomes .
-CONCLUSIONS	This delirium phenotype selects for a rapid high amplitude critical decline in attention , executive function , IADL , and apathy that recovers almost as rapidly .
-
-###24662855
-BACKGROUND	The incidence of deep venous thrombosis ( DVT ) remains high in general surgery and trauma patients despite widespread prophylaxis with enoxaparin .
-BACKGROUND	A recent study demonstrated decreased incidence of DVT if patients on enoxaparin had a change in R time ( R ) of greater than 1 minute when heparinase-activated thromboelastography ( TEG ) was compared with normal TEG .
-BACKGROUND	We hypothesized that using R-guided dosing would result in decreased DVT rates .
-METHODS	A prospective , randomized controlled trial was performed at a Level 1 trauma center .
-METHODS	Both trauma and general surgery patients were included .
-METHODS	Upon enrollment , demographic data including age , sex , body mass index , and Acute Physiology and Chronic Health Evaluation II score were obtained .
-METHODS	Enrolled patients were randomized to standard ( 30 mg twice a day ) or TEG-guided dosing .
-METHODS	Dose-adjusted patients underwent daily enoxaparin titration to achieve an R of 1 minute to 2 minutes .
-METHODS	Venous thromboembolism screening was performed per institutional protocol .
-METHODS	Antithrombin III ( AT-III ) and anti-Xa levels were drawn at peak enoxaparin concentrations .
-RESULTS	A total of 87 patients were enrolled .
-RESULTS	There was no difference in demographic data between the groups .
-RESULTS	No pulmonary emboli were identified .
-RESULTS	The control group had a DVT rate of 16 % , while the experimental group had a rate of 14 % ( p = nonsignificant ) .
-RESULTS	The experimental group 's median enoxaparin dosage , 50 mg twice a day , was significantly higher than that of the control ( p < 0.01 ) .
-RESULTS	TEG R was not different between the control and experimental groups .
-RESULTS	Beginning at Day 3 , anti-Xa levels were higher in the experimental group ( p < 0.05 ) .
-RESULTS	There was no difference in AT-III activity between the two groups ; 67 % of the patients demonstrated AT-III deficiency .
-CONCLUSIONS	TEG adjusted enoxaparin dosing led to significant increases in anti-Xa activity , which did not correlate with a decreased DVT rate .
-CONCLUSIONS	Failure to reduce the DVT rate and increase R despite increased dosing and increased anti-Xa activity is consistent with the high rate of AT-III deficiency detected in this study cohort .
-CONCLUSIONS	These data suggest that the future of DVT prevention may not lie in the optimization of low molecular weight heparin therapy but rather in compounds that increase antithrombin directly or operate independently of the AT-III pathway .
-METHODS	Therapeutic study , level III .
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-###25091932
-BACKGROUND	Sexuality is an important aspect of human life and sexual problems are common , but there is limited evidence for cost-effective treatments of women 's sexual dysfunctions .
-OBJECTIVE	The aim of this study was to assess whether group therapy such as Sexual Health Model ( SHM ) can be as effective as individual therapy like Permission , Limited Information , Specific Suggestions , and Intensive Therapy ( PLISSIT ) model in women with sexual problems .
-METHODS	A randomized controlled trial was conducted between May 2012 and September 2013 in five Tehran , Iran health clinics .
-METHODS	Eighty-four consecutive married women aged 20-52 years , with sexual problems who were admitted for the first time , were recruited and randomized into two groups .
-METHODS	The intervention included two therapeutic models : the SHM , which consisted of two sessions of 3 hours of group education , and the PLISSIT model , which required a total of 6 hours of one-on-one consultation at an interval of 1-2 weeks .
-METHODS	Sexual function and sexual distress were assessed , respectively , with the Brief Index of Sexual Function for Women and Female Sexual Distress Scale Revised questionnaires .
-RESULTS	Seven months after intervention , the mean ( SD ) of the sexual distress score decreased and sexual composite score increased significantly in both groups ( P < 0.001 ) .
-RESULTS	The overall analysis of repeated measure manova revealed borderline significance differences for combined outcomes between two groups ( P = 0.051 ) .
-CONCLUSIONS	Due to the considerable human resource , time , and cost spent conducting the PLISSIT , it seems that group education based on SHM could be more cost-efficient and nearly as effective .
-CONCLUSIONS	This conclusion may be more applicable in communities where the treatment of sexual problems is in the beginning stages and where people have not received any sexual education or knowledge during their lifetime .
-
-###25005467
-OBJECTIVE	To assess the safety and efficacy of intravenous ( IV ) abatacept plus methotrexate ( MTX ) over 7 years , the longest observational period to date , in patients with established rheumatoid arthritis ( RA ) and an inadequate response to MTX .
-METHODS	Patients randomised to IV abatacept ( 10 or 2 mg/kg ) or placebo , plus MTX , during the 1-year double-blind ( DB ) period of a Phase 2b study could enter the long-term extension ( LTE ) and receive IV abatacept 10 mg/kg monthly .
-METHODS	Safety was assessed in patients who received 1 dose of abatacept ; efficacy was assessed in patients originally randomised to 10 mg/kg abatacept ( as-observed data ) .
-RESULTS	A total of 219 patients entered the LTE ; 114 ( 52.1 % ) completed 7 years of treatment with abatacept plus MTX .
-RESULTS	Cumulative ( DB + LTE ) incidence rates of serious adverse events , serious infections , malignancies , and autoimmune events were 17.6 , 3.2 , 1.8 , and 1.2 / 100 patient-years , respectively .
-RESULTS	Safety was consistent between the DB ( n = 220 ) and cumulative ( n = 287 ) periods .
-RESULTS	Improvements in American College of Rheumatology responses , disease activity , and normalisation of physical function and health-related quality of life were maintained over time .
-RESULTS	Approximately 80 % of patients who achieved low disease activity or normalised modified Health Assessment Questionnaire scores at Year 1 , and who remained in the study , sustained these responses in each subsequent year .
-CONCLUSIONS	IV abatacept in combination with MTX demonstrated consistent safety and sustained efficacy over 7 years in MTX inadequate responders with established RA .
-CONCLUSIONS	Furthermore , some patients demonstrated a normalisation of physical function and health-related quality of life that was sustained over time .
-
-###24732629
-BACKGROUND	In vitro , animal , and ecological studies suggest that inadequate vitamin D intake could increase prostate cancer risk , but results of biomarker-based longitudinal studies are inconsistent .
-METHODS	Data for this case ( n = 1,731 ) and cohort ( n = 3,203 ) analysis are from the Selenium and Vitamin E Cancer Prevention Trial .
-METHODS	Cox proportional hazard models were used to test whether baseline plasma vitamin D ( 25-hydroxy ) concentration , adjusted for season of blood collection , was associated with the risk of total and Gleason score 2-6 , 7-10 , and 8-10 prostate cancer .
-RESULTS	There were U-shaped associations of vitamin D with total cancer risk : compared with the first quintile , HRs were 0.83 [ 95 % confidence interval ( CI ) , 0.66-1 .03 ; P = 0.092 ] , 0.74 ( 95 % CI , 0.59-0 .92 ; P = 0.008 ) , 0.86 ( 95 % CI , 0.69-1 .07 ; P = 0.181 ) , and 0.98 ( 95 % CI , 0.78-1 .21 ; P = 0.823 ) , for the second through fifth quintiles , respectively .
-RESULTS	For Gleason 7-10 cancer , corresponding HRs were 0.63 ( 95 % CI , 0.45-0 .90 ; P = 0.010 ) , 0.66 ( 95 % CI , 0.47-0 .92 ; P = 0.016 ) , 0.79 ( 95 % CI , 0.56-1 .10 ; P = 0.165 ) , and 0.88 ( 95 % CI , 0.63-1 .22 ; P = 0.436 ) .
-RESULTS	Among African American men ( n = 250 cases ) , higher vitamin D was associated with reduced risk of Gleason 7-10 cancer only : in the a posteriori contrast of quintiles 1-2 versus 3-5 , the HR was 0.55 ( 95 % CI , 0.31-0 .97 ; P = 0.037 ) , with no evidence of dose-response or a U-shaped association .
-CONCLUSIONS	Both low and high vitamin D concentrations were associated with increased risk of prostate cancer , and more strongly for high-grade disease .
-CONCLUSIONS	The optimal range of circulating vitamin D for prostate cancer prevention may be narrow .
-CONCLUSIONS	Supplementation of men with adequate levels may be harmful .
-CONCLUSIONS	Cancer Epidemiol Biomarkers Prev ; 23 ( 8 ) ; 1494-504 .2014 AACR .
-
-###24931900
-BACKGROUND	Traditionally , outpatient visits for COPD are fixed , pre-planned by the pulmonologist .
-BACKGROUND	This is not a patient centered method , nor , in times of increasing COPD prevalence and resource constraints , perhaps the optimal method .
-OBJECTIVE	This pilot study , determined the effect of an on-demand-system , patient initiated outpatient visits , on health status , COPD-related healthcare resource-use and costs .
-METHODS	Patients were randomized between on-demand-system ( n = 49 ) and usual care ( n = 51 ) , with a 2-year follow-up .
-METHODS	Primary , health status was assessed with Clinical COPD Questionnaire ( CCQ ) .
-METHODS	Secondary endpoints were : St. George 's Respiratory Questionnaire ( SGRQ ) , Short Form-36 ( SF-36 ) scores , visits to general practitioners ( GP ) , pulmonologists , and pulmonary nurse practitioners ( PNP ) , exacerbations and total treatment costs from healthcare providers and healthcare insurance perspectives .
-RESULTS	Participants had a mean FEV ( 1 ) 1.3 0.4 liters and were 69 9 years .
-RESULTS	CCQ total scores deteriorated in both groups , with no significant difference between them .
-RESULTS	CCQ symptom domain did show a significant and clinically relevant difference in favor of the on-demand-group , -0.4 0.21 , CI95 % -0.87 ; -0.02 , p = 0.04 .
-RESULTS	Similar tendency was found for the SGRQ whereas results for SF-36 were inconsistent .
-RESULTS	Patients in the on-demand-group visited GP significantly less ( p = 0.01 ) , but PNP significantly more , p = 0.003 .
-RESULTS	Visits to pulmonologists and exacerbations were equally frequent in both groups .
-RESULTS	Mean total costs per patient were lower in the on-demand-group in comparison with usual care , difference of -518 ( -1993 ; 788 ) from healthcare provider and -458 ( -2700 ; 1652 ) insurance perspective .
-CONCLUSIONS	The on-demand-system was comparable with usual care , had a cost-saving tendency , and can be instituted with confidence in the COPD outpatient care setting .
-
-###24441085
-BACKGROUND	Music is considered a subset of developmental supportive care .
-BACKGROUND	It may act as a suitable auditory stimulant in preterm infants .
-BACKGROUND	Also , it may reduce stress responses in autonomic , motor and state systems .
-OBJECTIVE	To assess and compare the influence of lullaby and classical music on physiologic parameters .
-METHODS	This is a randomized clinical trial with cross-over design .
-METHODS	A total of 25 stable preterm infants with birth weight of 1000-2500 grams were studied for six consecutive days .
-METHODS	Each infant was exposed to three phases : lullaby music , classical music , and no music ( control ) for two days each .
-METHODS	The sequence of these phases was assigned randomly to each subject .
-METHODS	Babies were continuously monitored for heart rate , respiratory rate , and oxygen saturation and changes between phases were analyzed .
-RESULTS	Lullaby reduced heart rate ( p < 0.001 ) and respiratory rate ( p = 0.004 ) .
-RESULTS	These effects extended in the period after the exposure ( p < .001 and p = 0.001 , respectively ) .
-RESULTS	Classical music reduced heart rate ( p = 0.018 ) .
-RESULTS	The effects of classical music disappeared once the music stopped .
-RESULTS	Oxygen saturation did not change during intervention .
-CONCLUSIONS	Music can affect vital signs of preterm infants ; this effect can possibly be related to the reduction of stress during hospitalization .
-CONCLUSIONS	The implications of these findings on clinical and developmental outcomes need further study .
-
-###25102884
-OBJECTIVE	To assess the effects of DICLORAL 's alleviation of pain caused by radiation-induced oral mucositis .
-METHODS	With compound borax solution as a comparative drugs ' the solution of DICLORAL was adopted for patients with radiation-induced oral mucositis due to radiotherapy for nasal NK/T cell lymphoma .
-METHODS	All 59 patients were randomly divided into 2 groups : experimental group ( using DICLORAL ) and control group ( using Compound Borax Solution ) .
-METHODS	During the treatment , we observed drugs ' ability of alleviate oral pain or pain on swallowing , when it worked and how long it could sustain in controlling pain .
-METHODS	Statistical analysis was performed using SPSS 16.0 software package .
-RESULTS	Drugs ' ability of alleviate oral pain or pain on swallowing and the onset time was not significantly different between the 2 groups ( P > 0.05 ) .
-RESULTS	Effective duration in experimental group was longer than that in control group ( P < 0.05 ) .
-CONCLUSIONS	DICORAL can alleviate and cease pain caused by radiation-induced oral mucositis effectively .
-
-###25074878
-OBJECTIVE	We evaluated associations among comorbidity , toxicity , time to relapse ( TTR ) , and overall survival ( OS ) in older women with early-stage breast cancer receiving adjuvant chemotherapy .
-METHODS	Cancer and Leukemia Group B 49907 ( Alliance ) randomly assigned women 65 years old with stages I-III breast cancer to standard adjuvant chemotherapy or capecitabine .
-METHODS	We reviewed data from 329 women who participated in the quality of life companion study CALGB 70103 and completed the Physical Health Subscale of the Older American Resources and Services Questionnaire .
-METHODS	This questionnaire captures data on 14 comorbid conditions and the degree to which each interferes with daily activities .
-METHODS	A comorbidity burden score was computed by multiplying the total number of conditions by each condition 's level of interference with function .
-METHODS	Outcomes were grade 3 to 5 toxicity , TTR , and OS .
-METHODS	Logistic regression was used to evaluate associations between comorbidity and toxicity , and Cox proportional hazards models for TTR and survival .
-RESULTS	Number of comorbidities ranged from 0 to 10 ( median 2 ) ; the comorbidity burden score ranged from 0 to 25 ( median 3 ) .
-RESULTS	The most common conditions were arthritis ( 58 % ) and hypertension ( 55 % ) .
-RESULTS	Comorbidity was associated with shorter OS , but not with toxicity or TTR .
-RESULTS	The hazard of death increased by 18 % for each comorbidity ( hazard ratio [ HR ] = 1.18 , 95 % CI = 1.06 to 1.33 ) after adjusting for age , tumor size , treatment , node and receptor status .
-RESULTS	Comorbidity burden score was similarly associated with OS ( HR = 1.08 ; 95 % CI , 1.03 to 1.14 ) .
-CONCLUSIONS	Among older women enrolled onto a clinical trial , comorbidity was associated with shorter OS , but not toxicity or relapse .
-
-###24727369
-BACKGROUND	Research needs to systematically identify which components increase online intervention effectiveness ( i.e. , active ingredients ) .
-BACKGROUND	This study explores the effects of 4 potentially important design features in an Internet-based , population-level smoking intervention .
-METHODS	Smokers ( n = 1,865 ) were recruited from a large health care organization , regardless of readiness to quit .
-METHODS	Using a full factorial design , participants were randomized to 1 of the 2 levels of each experimental factor ( message tone [ prescriptive vs. motivational ] , navigation autonomy [ dictated vs. not ] , e-mail reminders [ yes vs. no ] , and receipt of personally tailored testimonials [ yes vs. no ] ) and provided access to the online intervention .
-METHODS	Primary outcomes were self-reported 7-day point-prevalent smoking abstinence and confirmed utilization of adjunct treatment ( pharmacotherapy or phone counseling ) available through the health plan at 1 year .
-METHODS	Outcomes were also assessed at 2 and 6 months and were examined among all enrolled participants ( intent-to-treat [ ITT ] ) and all who viewed the intervention ( modified ITT ) .
-RESULTS	At 1 year , 13.7 % were abstinent and 26.0 % utilized adjunct treatment .
-RESULTS	None of the contrasting factor levels differentially influenced abstinence or treatment utilization at 12 months .
-RESULTS	In the modified ITT sample , smokers receiving testimonials were less likely to use adjunct treatment at 6 months ( odds ratio = 0.54 , 95 % confidence interval = 0.30-0 .98 , p = .04 ) .
-CONCLUSIONS	None of the design features enhanced treatment outcome .
-CONCLUSIONS	The negative effect observed for testimonials is provocative , but it should be viewed with caution .
-CONCLUSIONS	This study offers a model for future research testing the `` active ingredients '' of online interventions .
-
-###24836914
-BACKGROUND	Intervention studies for children at risk of dyslexia have typically been delivered preschool , and show short-term effects on letter knowledge and phoneme awareness , with little transfer to literacy .
-METHODS	This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children identified by research criteria as being at risk of dyslexia ( n = 56 ) , and their school-identified peers ( n = 89 ) .
-METHODS	An Experimental group received two 9-week blocks of daily intervention delivered by trained teaching assistants ; the Control group received 9 weeks of typical classroom instruction , followed by 9 weeks of intervention .
-RESULTS	Following mixed effects regression models and path analyses , small-to-moderate effects were shown on letter knowledge , phoneme awareness and taught vocabulary .
-RESULTS	However , these were fragile and short lived , and there was no reliable effect on the primary outcome of word-level reading .
-CONCLUSIONS	This new intervention was theoretically motivated and based on previous successful interventions , yet failed to show reliable effects on language and literacy measures following a rigorous evaluation .
-CONCLUSIONS	We suggest that the intervention may have been too short to yield improvements in oral language ; and that literacy instruction in and beyond the classroom may have weakened training effects .
-CONCLUSIONS	We argue that reporting of null results makes an important contribution in terms of raising standards both of trial reporting and educational practice .
-
-###26214630
-OBJECTIVE	Combined modality therapy is standard of care for patients with unresectable locally advanced non-small cell lung cancer ( NSCLC ) , however , insufficient data exist regarding prognostic factors in this disease setting .
-METHODS	To evaluate the treatment results and prognostic variables , 85 NSCLC patients treated from October 2005 to April 2008 were randomly assigned to one of the two treatment arms .
-METHODS	In the first arm ( sequential arm ) , 45 patients received sequential chemotherapy with 4 cycles of carboplatin and etoposide followed by conformal 3-dimensional ( 3D ) radiotherapy ( RT ) .
-METHODS	In the second arm ( concurrent arm ) , 40 patients received concomitant chemotherapy with cisplatin and etoposide and conformal RT , followed by two cycles of consolidation chemotherapy with carboplatin and etoposide .
-RESULTS	The median survival was 13 months for the patients in the sequential arm and 19 months for those in the concurrent treatment arm ( p = 0.0039 ) .
-RESULTS	The disease-free survival ( DFS ) was 9 months in the sequential arm and 16 months in the concurrent treatment arm ( p = 0.0023 ) .
-RESULTS	The following prognostic factors significantly influenced the survival of the patients treated with combination of RT and chemotherapy : age ( p < 0.05 ) , performance status ( PS ) ( p < 0.001 ) , weight loss ( p < 0.001 ) , tumor size ( p < 0.05 ) , nodal involvement ( p < 0.05 ) .
-CONCLUSIONS	Given the higher toxicity in the second arm , this should be reserved for younger patients ( < 70 years ) , having good PS and minimal weight loss .
-CONCLUSIONS	We highly recommend precise stage and prognostic factors definitions in such patients so that they receive the most beneficial treatment .
-
-###25736134
-OBJECTIVE	To observe the effects of different loading doses of atorvastatin calcium on the outcomes of percutaneous coronary intervention ( PCI ) in elderly patients with coronary heart disease ( CHD ) .
-METHODS	A total of 120 CHD patients aged over 80 years were randomly assigned into 3 equal groups to receive intensive pretreatment with statin at the doses of 20 , 40 , or 60 mg prior to PCI performed within 48 to 72 h after admission .
-METHODS	The changes of postoperative cardiac biochemical markers including creatine kinase isoenzyme ( CKMB ) , troponin I ( cTNI ) and high-sensitivity c-reactive protein ( hs-CRP ) were observed and the incidence of major adverse cardiac events ( MACE , including cardiac death , myocardial infarction , and target vessel revascularization ) were recorded within 30 days after PCI .
-RESULTS	Thirty-four patients in 20 mg statin group , 40 in 40 mg statin group , and 38 in 60 mg statin group completed this study .
-RESULTS	In all the 3 groups , hs-CRP level significantly increased at 12 and 24 h after PCI compared with the preoperative levels ( P < 0.05 ) .
-RESULTS	The patients in 60 mg statin group showed significantly lower levels of CKMB , cTNI , and hs-CRP at 24 h after PCI than those in 20 mg statin group ( P < 0.05 ) , and had also a significantly lower incidence of total MACE within 30 days after PCI ( 2.6 % vs 26.5 % , P = 0.003 ) resulting primarily from significantly reduced myocardial infarction associated with PCI ( 2.6 % vs 20.6 % , P = 0.016 ) .
-RESULTS	The adverse drug reactions were comparable among the 3 groups ( P > 0.05 ) .
-CONCLUSIONS	Intensive pretreatment with 60 mg/day atorvastatin calcium can significantly reduce myocardial infarction related to PCI with good safety in elderly patients with CHD .
-
-###24708292
-OBJECTIVE	Luseogliflozin -- a novel , orally bioavailable , 1-thio-D-glucitol derivative and a selective sodium glucose cotransporter 2 inhibitor -- has shown efficacy and tolerability in previous phase 2 studies .
-OBJECTIVE	This phase 3 , randomized , double-blind , placebo-controlled , comparative study aimed to confirm the superiority of 24 week luseogliflozin 2.5 mg monotherapy over placebo in reducing hemoglobin A1c ( HbA1c ) levels in Japanese patients with type 2 diabetes mellitus ( T2DM ) .
-METHODS	Patients with HbA1c levels of 6.9 % -10.5 % were randomized to receive luseogliflozin 2.5 mg or placebo once daily for 24 weeks ( n = 79 in each group ) .
-METHODS	The primary endpoint was change from baseline in HbA1c at end of treatment .
-METHODS	Secondary endpoints included change from baseline in fasting plasma glucose ( FPG ) and postprandial plasma glucose ( PPG ) following a meal tolerance test , body weight , and abdominal circumference .
-METHODS	Safety assessments included adverse events ( AEs ) , clinical laboratory tests , and vital signs .
-RESULTS	At the end of treatment , HbA1c was significantly decreased from baseline in the luseogliflozin 2.5 mg group ( -0.63 % ) versus the placebo group ( 0.13 % ) , with a between-group difference of -0.75 % ( p < 0.001 ) .
-RESULTS	Additionally , significant reductions in FPG , PPG , body weight , and abdominal circumference were noted with luseogliflozin compared with placebo ( all p < 0.05 ) .
-RESULTS	Luseogliflozin was well tolerated ; there was no significant difference between groups in the incidence of AEs ( luseogliflozin , 59.5 % ; placebo , 57.0 % ) .
-RESULTS	No AEs led to study drug discontinuation .
-RESULTS	Most AEs were mild in severity , with no severe AE reported .
-RESULTS	Limitations of this study include its short study duration and small sample size .
-CONCLUSIONS	Luseogliflozin monotherapy for 24 weeks was superior to placebo in reducing HbA1c levels .
-CONCLUSIONS	It also reduced FPG , PPG , body weight , and abdominal circumference and was well tolerated in Japanese patients with T2DM .
-BACKGROUND	JapicCTI-111661 .
-
-###25336746
-OBJECTIVE	Glycated hemoglobin ( HbA1c ) , a standard measure of chronic glycemia for managing diabetes , has been proposed to diagnose diabetes and identify people at risk .
-OBJECTIVE	The Diabetes Prevention Program ( DPP ) was a 3.2-year randomized clinical trial of preventing type 2 diabetes with a 10-year follow-up study , the DPP Outcomes Study ( DPPOS ) .
-OBJECTIVE	We evaluated baseline HbA1c as a predictor of diabetes and determined the effects of treatments on diabetes defined by an HbA1c 6.5 % ( 48 mmol/mol ) .
-METHODS	We randomized 3,234 nondiabetic adults at high risk of diabetes to placebo , metformin , or intensive lifestyle intervention and followed them for the development of diabetes as diagnosed by fasting plasma glucose ( FPG ) and 2-h postload glucose ( 2hPG ) concentrations ( 1997 American Diabetes Association [ ADA ] criteria ) .
-METHODS	HbA1c was measured but not used for study eligibility or outcomes .
-METHODS	We now evaluate treatment effects in the 2,765 participants who did not have diabetes at baseline according to FPG , 2hPG , or HbA1c ( 2010 ADA criteria ) .
-RESULTS	Baseline HbA1c predicted incident diabetes in all treatment groups .
-RESULTS	Diabetes incidence defined by HbA1c 6.5 % was reduced by 44 % by metformin and 49 % by lifestyle during the DPP and by 38 % by metformin and 29 % by lifestyle throughout follow-up .
-RESULTS	Unlike the primary DPP and DPPOS findings based on glucose criteria , metformin and lifestyle were similarly effective in preventing diabetes defined by HbA1c .
-CONCLUSIONS	HbA1c predicted incident diabetes .
-CONCLUSIONS	In contrast to the superiority of the lifestyle intervention on glucose-defined diabetes , metformin and lifestyle interventions had similar effects in preventing HbA1c-defined diabetes .
-CONCLUSIONS	The long-term implications for other health outcomes remain to be determined .
-
-###25219353
-OBJECTIVE	To evaluate the efficacy , safety , and pharmacokinetics of rufinamide as an adjunctive therapy for patients with Lennox-Gastaut syndrome ( LGS ) in a randomized , double-blind , placebo-controlled trial .
-METHODS	We conducted a multicenter clinical trial with a 4-week baseline , a 2-week titration , a 10-week maintenance , and either a follow-up visit or entry into an open-label extension .
-METHODS	Patients with LGS ( 4 to 30 years old ) taking between one and three antiepileptic drugs were recruited .
-METHODS	After the baseline period , patients were randomly assigned to rufinamide or placebo .
-METHODS	The primary efficacy variable was the percent change in the tonic-atonic seizure frequency per 28 days .
-RESULTS	Of the 59 patients , 29 were randomized to the rufinamide group and 30 to the placebo group .
-RESULTS	The frequency of epileptic seizures was significantly decreased in the rufinamide group than in the placebo group ; the median percent change in frequency of tonic-atonic seizures was -24.2 % and -3.3 % , respectively , ( p = 0.003 ) and that of total seizures was -32.9 % and -3.1 % , respectively ( p < 0.001 ) .
-RESULTS	Subgroup analyses indicated that the efficacy of rufinamide was consistent independent of clinical background characteristics .
-RESULTS	The common treatment-related adverse events in the rufinamide group were decreased appetite ( 17.2 % ) , somnolence ( 17.2 % ) , and vomiting ( 13.8 % ) .
-RESULTS	Transient seizure aggravations were observed in 13 ( 22.0 % ) of the 59 patients , though a causal relationship with rufinamide was suspected in only one patient .
-RESULTS	All adverse events were mild to moderate in severity .
-RESULTS	The mean plasma concentration of rufinamide between 1 and 9 within 12h after administration was 17.2 g/mL .
-CONCLUSIONS	The present results showed a favorable risk-benefit profile for rufinamide as an adjunctive therapy for patients with LGS .
-
-###25103686
-BACKGROUND	Exercise therapy in patients with hip and/or knee osteoarthritis is effective in reducing pain , increasing physical activity and physical functioning , but costly and a burden for the health care budget .
-BACKGROUND	A web-based intervention is cheap in comparison to face-to-face exercise therapy and has the advantage of supporting in home exercises because of the 24/7 accessibility .
-BACKGROUND	However , the lack of face-to-face contact with a professional is a disadvantage of web-based interventions and is probably one of the reasons for low adherence rates .
-BACKGROUND	In order to combine the best of two worlds , we have developed the intervention e-Exercise .
-BACKGROUND	In this blended intervention face-to-face contacts with a physical therapist are partially replaced by a web-based exercise intervention .
-BACKGROUND	The aim of this study is to investigate the short - ( 3 months ) and long-term ( 12 months ) ( cost ) - effectiveness of e-Exercise compared to usual care physical therapy .
-BACKGROUND	Our hypothesis is that e-Exercise is more effective and cost-effective in increasing physical functioning and physical activity compared to usual care .
-METHODS	This paper presents the protocol of a prospective , single-blinded , multicenter cluster randomized controlled trial .
-METHODS	In total , 200 patients with OA of the hip and/or knee will be randomly allocated into either e-Exercise or usual care ( physical therapy ) .
-METHODS	E-Exercise is a 12-week intervention , consisting of maximum five face-to-face physical therapy contacts supplemented with a web-based program .
-METHODS	The web-based program contains assignments to gradually increase patients ' physical activity , strength and stability exercises and information about OA related topics .
-METHODS	Primary outcomes are physical activity and physical functioning .
-METHODS	Secondary outcomes are health related quality of life , self-perceived effect , pain , tiredness and self-efficacy .
-METHODS	All measurements will be performed at baseline , 3 and 12 months after inclusion .
-METHODS	Retrospective cost questionnaires will be sent at 3 , 6 , 9 and 12 months and used for the cost-effectiveness and cost-utility analysis .
-CONCLUSIONS	This study is the first randomized controlled trial in the ( cost ) - effectiveness of a blended exercise intervention for patients with osteoarthritis of the hip and/or knee .
-CONCLUSIONS	The findings will help to improve the treatment of patients with osteoarthritis .
-BACKGROUND	NTR4224 .
-
-###24448738
-BACKGROUND	A variant ( rs3812316 , C771G , and Gln241His ) in the MLXIPL ( Max-like protein X interacting protein-like ) gene encoding the carbohydrate response element binding protein has been associated with lower triglycerides .
-BACKGROUND	However , its association with cardiovascular diseases and gene-diet interactions modulating these traits are unknown .
-RESULTS	We studied 7166 participants in the PREvencin with DIeta MEDiterrnea trial testing a Mediterranean diet ( MedDiet ) intervention versus a control diet for cardiovascular prevention , with a median follow-up of 4.8 years .
-RESULTS	Diet , lipids , MLXIPL polymorphisms , and cardiovascular events were assessed .
-RESULTS	Data were analyzed at baseline and longitudinally .
-RESULTS	We used multivariable-adjusted Cox regression to estimate hazard ratios for cardiovascular outcomes .
-RESULTS	The MLXIPL-rs3812316 was associated with lower baseline triglycerides ( P = 5.510 ( -5 ) ) and lower hypertriglyceridemia ( odds ratio , 0.73 ; 95 % confidence interval [ CI ] , 0.63-0 .85 ; P = 1.410 ( -6 ) in G-carriers versus CC ) .
-RESULTS	This association was modulated by baseline adherence to MedDiet .
-RESULTS	When adherence to MedDiet was high , the protection was stronger ( odds ratio , 0.63 ; 95 % CI , 0.51-0 .77 ; P = 8.610 ( -6 ) ) than when adherence to MedDiet was low ( odds ratio , 0.88 ; 95 % CI , 0.70-1 .09 ; P = 0.219 ) .
-RESULTS	Throughout the follow-up , both the MLXIPL-rs3812316 ( P = 3.810 ( -6 ) ) and the MedDiet intervention ( P = 0.030 ) were significantly associated with decreased triglycerides .
-RESULTS	Likewise in G-carriers MedDiet intervention was associated with greater total cardiovascular risk reduction and specifically for myocardial infarction .
-RESULTS	In the MedDiet , but not in the control group , we observed lower myocardial infarction incidence in G-carriers versus CC ( hazard ratios , 0.34 ; 95 % CI , 0.12-0 .93 ; P = 0.036 and 0.90 ; 95 % CI , 0.35-2 .33 ; P = 0.830 , respectively ) .
-CONCLUSIONS	Our novel results suggest that MedDiet enhances the triglyceride-lowering effect of the MLXIPL-rs3812316 variant and strengthens its protective effect on myocardial infarction incidence .
-BACKGROUND	URL : www.controlled-trials.com .
-BACKGROUND	Unique Identifier : ISRCTN35739639 .
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-###24795142
-BACKGROUND	Children with febrile urinary tract infection commonly have vesicoureteral reflux .
-BACKGROUND	Because trial results have been limited and inconsistent , the use of antimicrobial prophylaxis to prevent recurrences in children with reflux remains controversial .
-METHODS	In this 2-year , multisite , randomized , placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infection , we evaluated the efficacy of trimethoprim-sulfamethoxazole prophylaxis in preventing recurrences ( primary outcome ) .
-METHODS	Secondary outcomes were renal scarring , treatment failure ( a composite of recurrences and scarring ) , and antimicrobial resistance .
-RESULTS	Recurrent urinary tract infection developed in 39 of 302 children who received prophylaxis as compared with 72 of 305 children who received placebo ( relative risk , 0.55 ; 95 % confidence interval [ CI ] , 0.38 to 0.78 ) .
-RESULTS	Prophylaxis reduced the risk of recurrences by 50 % ( hazard ratio , 0.50 ; 95 % CI , 0.34 to 0.74 ) and was particularly effective in children whose index infection was febrile ( hazard ratio , 0.41 ; 95 % CI , 0.26 to 0.64 ) and in those with baseline bladder and bowel dysfunction ( hazard ratio , 0.21 ; 95 % CI , 0.08 to 0.58 ) .
-RESULTS	The occurrence of renal scarring did not differ significantly between the prophylaxis and placebo groups ( 11.9 % and 10.2 % , respectively ) .
-RESULTS	Among 87 children with a first recurrence caused by Escherichia coli , the proportion of isolates that were resistant to trimethoprim-sulfamethoxazole was 63 % in the prophylaxis group and 19 % in the placebo group .
-CONCLUSIONS	Among children with vesicoureteral reflux after urinary tract infection , antimicrobial prophylaxis was associated with a substantially reduced risk of recurrence but not of renal scarring .
-CONCLUSIONS	( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; RIVUR ClinicalTrials.gov number , NCT00405704 . )
-
-###25527253
-OBJECTIVE	To ( 1 ) determine the efficacy of venlafaxine XR for the treatment of pain ( secondary aim ) in individuals with spinal cord injury ( SCI ) enrolled in a randomized controlled trial ( RCT ) on the efficacy of venlafaxine XR for major depressive disorder ( MDD ) ( primary aim ) ; and ( 2 ) test the hypothesis that venlafaxine XR would be effective for both neuropathic and nociceptive pain .
-METHODS	Multisite , double-blind , randomized ( 1:1 ) controlled trial with subjects block randomized and stratified by site , lifetime history of substance abuse , and prior history of MDD .
-METHODS	Six Departments of Physical Medicine and Rehabilitation in university-based medical schools .
-METHODS	Individuals ( N = 123 ) with SCI and major depression between 18 and 64 years of age , at least 1 month post-SCI who also reported pain .
-METHODS	Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule .
-METHODS	A 0-to-10 numeric rating scale for pain , pain interference items of the Brief Pain Inventory ; 30 % and 50 % responders .
-RESULTS	The effect of venlafaxine XR on neuropathic pain was similar to that of placebo .
-RESULTS	However venlafaxine XR resulted in statistically significant and clinically meaningful reductions in nociceptive pain site intensity and interference even after controlling for anxiety , depression , and multiple pain sites within the same individual .
-RESULTS	For those who achieved a minimally effective dose of venlafaxine XR , some additional evidence of effectiveness was noted for those with mixed ( both neuropathic and nociceptive ) pain sites .
-CONCLUSIONS	Venlafaxine XR could complement current medications and procedures for treating pain after SCI and MDD that has nociceptive features .
-CONCLUSIONS	Its usefulness for treating central neuropathic pain is likely to be limited .
-CONCLUSIONS	Research is needed to replicate these findings and determine whether the antinociceptive effect of venlafaxine XR generalizes to persons with SCI pain without MDD .
-
-###25098075
-BACKGROUND	Movie-based simulation training may be useful in delivering the preclinical observed OSPE curriculum , minimising the need of subjects/patients : however , a double-control trial needs to be performed and optimal timing and duration of training is yet to be defined .
-BACKGROUND	Likewise , gender-based response and students ' feedback has to be assessed .
-BACKGROUND	The objective of this study was to compare the movie-based and traditional verbal demonstration teaching methodologies .
-METHODS	Second-year medical undergraduates ( n = 90 ) of Avicenna Medical College were randomised to movie-based simulation training ( group B , n = 30 ) , traditional verbal training alone ( group C , n = 30 ) , and a combination ( group A , n = 30 ) .
-METHODS	The scores were marked by observers using a standardised key and were compared for performance at 2 observed OSPE stations .
-RESULTS	Group B and A performed significantly better than group C on station 1 and 2 .
-RESULTS	Gender factor did not seem to influence the score .
-RESULTS	A total of 99 % students reported that combination of the 2 teaching modes is the best option .
-RESULTS	They believed it offers more clear understanding with interest ( 61 % ) , long term memory ( 21 % ) , use of both senses ; seeing & hearing ( 10 % ) & better focus of attention ( 3 % ) .
-CONCLUSIONS	Even half an hour of movie-based simulation training with traditional instructor-based training may improve student performance significantly , and the students prefer a combination of the both .
-
-###25578377
-OBJECTIVE	Although achieving a pathological complete response ( pCR ) after neoadjuvant chemotherapy ( NACT ) in breast cancer predicts a better outcome , some patients still relapse .
-OBJECTIVE	The objectives of this study were to describe the types of events in this group of patients and to identify predictive factors for relapse .
-METHODS	Patients with large operable or locally advanced breast cancers ( T4d tumours were excluded ) were randomised to receive either six cycles of anthracycline-based chemotherapy or three cycles of docetaxel followed by three cycles of eprirubicin/docetaxel .
-METHODS	pCR was defined as no evidence of residual invasive cancer ( or very few scattered tumour cells ) in the primary tumour and axillary lymph nodes at surgery .
-METHODS	Two Cox regression analyses were performed to identify predictive factors of relapse : one for recurrence-free interval ( RFI ) and one for distant recurrence-free interval ( DRFI ) .
-RESULTS	Out of 283 eligible patients who achieved a pCR , 40 ( 14.1 % ) and 28 ( 9.9 % ) presented an event of interest for the RFI and DRFI analyses , respectively .
-RESULTS	Five-year RFI , DRFI and overall survival ( OS ) were 85.3 % ( 95 % confidence interval ( CI ) , 80.1-89 .3 ) , 89.6 % ( 95 % CI , 85.0-92 .9 ) and 91.9 % ( 95 % CI , 87.2-94 .9 ) , respectively .
-RESULTS	No predictors for RFI after pCR were identified .
-RESULTS	For DRFI , tumour size was the only predictor : Hazard ratio ( HR ) T3 versus T1-2 = 3.62 ( 95 % CI , 1.66-7 .89 ) ; HR T4 versus T1-2 : HR , 2.80 ( 95 % CI , 0.62-12 .64 ) p = 0.0048 .
-CONCLUSIONS	In this study , clinical tumour size emerged as the only predictor for DRFI after pCR , with T3 and T4 tumours having an increased risk for distant recurrence compared to T1-2 tumours .
-
-###24654927
-OBJECTIVE	The purpose of this study was to determine the reliability and validity of two smartphone applications : ( 1 ) GetMyROM - inclinometery-based and ( 2 ) DrGoniometry - photo-based in the measurement of active shoulder external rotation ( ER ) as compared to standard goniometry ( SG ) .
-METHODS	Ninety-four Texas Woman 's University Doctor of Physical Therapy students from the School of Physical Therapy - Houston campus , were recruited to participate in this study .
-METHODS	Two iPhone applications were compared to SG using both novice and experienced raters .
-METHODS	Active shoulder ER range of motion was measured over two time periods in random order by blinded novice and experienced raters .
-RESULTS	Intra-rater reliability using novice raters for the two applications ranged from an intraclass correlation coefficient ( ICC ) of 0.79 to 0.81 with SG at 0.82 .
-RESULTS	Inter-rater reliability ( novice/expert ) for the two applications ranged from an ICC of 0.92 to 0.94 with SG at 0.91 .
-RESULTS	Concurrent validity ( when compared to SG ) ranged from 0.93 to 0.94 .
-RESULTS	There were no significant differences between the novice and experienced raters .
-CONCLUSIONS	Both applications were found to be reliable and comparable to SG .
-CONCLUSIONS	A photo-based application potentially offers a superior method of measurement as visualizing the landmarks may be simplified in this format and it provides a record of measurement .
-CONCLUSIONS	Further study using patient populations may find the two studied applications are useful as an adjunct for clinical practice .
-
-###25001158
-OBJECTIVE	To compare the structural outcome at 9 months of eyes treated with intravitreal injection of bevacizumab with fellow eyes treated with conventional laser photoablation in zone I type 1 retinopathy of prematurity ( ROP ) .
-METHODS	Single randomized controlled trial .
-METHODS	All inborn babies with type 1 zone I ROP at a single institution were included in the study .
-METHODS	One eye was randomized to receive an intravitreal injection of 0.5 mg bevacizumab ; the fellow eye received conventional laser photoablation .
-METHODS	Digital fundus photographs and fluorescein angiography ( FA ) using the RetCam ( Clarity Medical Systems Inc. , Pleasanton , CA ) were performed before treatment and 9 months after treatment .
-METHODS	Presence of retinal and choroidal abnormalities on FA at 9 months .
-RESULTS	Thirteen infants were enrolled ; 1 died 3 months after birth .
-RESULTS	One laser-treated eye progressed to stage 5 retinal detachment .
-RESULTS	The remaining 23 eyes had favorable structural results at the 9-month follow-up and provided FA results .
-RESULTS	At 9 months of age , all eyes treated with a bevacizumab injection were noted to have abnormalities at the periphery ( large avascular area , abnormal branching , shunt ) or the posterior pole ( hyperfluorescent lesion , absence of foveal avascular zone ) .
-RESULTS	These posterior and peripheral lesions were not observed in the majority of the lasered eyes .
-CONCLUSIONS	This study documents significant vascular and macular abnormalities of eyes in the bevacizumab group .
-CONCLUSIONS	Long-lasting implications of these abnormalities for visual function of the child need to be studied .
-
-###24735707
-BACKGROUND	This randomized control trial assesses the effectiveness of motivational interviewing ( MI ) to encourage behavior change in new mothers relating to caries prevention when caring for their newborn American Indian ( AI ) infants and young AI children .
-METHODS	The study is a randomized control trial .
-METHODS	We hypothesize that when motivational interviewing is added to enhanced community oral health education services , the new mothers will achieve greater reduction of caries experience in their AI children compared to those who are receiving enhanced community services ( ECS ) alone .
-METHODS	Six hundred mothers or caregivers of AI newborns will be enrolled into the study and randomized to one of the two intervention groups over a two-year period .
-METHODS	The children will be followed until the child 's third birthday .
-METHODS	A cost analysis of the study is being conducted in tandem with the enhanced community services , motivational interviewing behavioral interventions , and the dental screenings for the length of the study .
-CONCLUSIONS	The trial is now in the implementation phase and a number of threats to successful completion , such as recruitment and retention challenges in a vast , rural geographic area , have been addressed .
-CONCLUSIONS	The protocol provides a unique model for oral health interventions using principles of community-based participatory research and is currently on schedule to meet study objectives .
-CONCLUSIONS	If the study is successful , motivational interviewing intervention can be applied in AI communities to reduce ECC disparities in this disadvantaged population , with study of further applicability in other populations and settings .
-BACKGROUND	ClinicalTrials.gov , NCT01116726 .
-
-###25172200
-OBJECTIVE	Despite a standardized prophylaxis with antibiotics , surgical site infections ( SSI ) are a characteristic problem in colorectal surgery .
-OBJECTIVE	Local administration of gentamicin-collagen sponges ( GCS ) has been shown to decrease the infection rate after contaminated procedures .
-OBJECTIVE	So far , the effect has not been tested for standardized laparoscopic colorectal resections .
-METHODS	We conducted a randomized , double-blind , placebo-controlled trial to investigate the efficacy of GCS to reduce wound infection after laparoscopic colorectal resections .
-METHODS	Patients underwent a standardized operative procedure with standardized incision treatment .
-METHODS	The intervention was the application of a GCS in the subcutaneous tissue of the bowel extraction site ( GCS group ) .
-METHODS	In the collagen group , a collagen sponge without antibiotics was used , and no sponge was used in the control group .
-METHODS	The primary endpoint was SSI within 30 days postoperatively , according to the Center of Disease Control and Prevention definition .
-RESULTS	We randomly assigned 291 patients to all three groups .
-RESULTS	There was no difference between the groups regarding demographic characteristics and perioperative course .
-RESULTS	SSI was diagnosed in 8.2 % ( GCS group ) , 13.5 % ( collagen group ) , and 11.3 % ( control group ) of patients .
-RESULTS	No significant difference was found among the groups .
-CONCLUSIONS	The local administration of GCS showed no significant benefit regarding wound infection after standardized laparoscopic colorectal resections .
-CONCLUSIONS	However , there was a trend toward reduced SSI in the GCS group .
-CONCLUSIONS	Therefore , a larger trial or meta-analysis is necessary to validate this result .
-
-###24369765
-BACKGROUND	There is some evidence in the literature that emphasising fish consumption may assist with weight loss .
-BACKGROUND	The aim was to assess the effects of advice to consume 2 fish meals per week in a weight loss diet .
-METHODS	A parallel randomised placebo-controlled trial was conducted in 118 obese Australian adults ( mean BMI SD 31.3 3.5 kg/m2 ; mean age SD 45 10 y ; 28 % male ) .
-METHODS	Participants received low calorie dietary advice + placebo ( 1 g olive oil ; CONTROL ) , low calorie dietary advice emphasising fish + placebo ( Fish ) , or low calorie dietary advice emphasising fish diet + LCn3PUFA supplements ( Fish + S ) .
-METHODS	Individualised advice targeted 2 MJ energy deficit ( 30 % E fat , 45 % E carbohydrate and 25 % E protein ) with or without two servings ( 180 g ) fatty fish/wk .
-RESULTS	All groups lost weight at 12 months ( CONTROL -4.5 kg vs. Fish -4.3 kg vs. Fish + S -3.3 kg ; p < 0.001 ) and percentage body fat (
-METHODS	-1.5 % vs. Fish : -1.4 % vs. Fish + S : -0.7 % ; p < 0.001 ) but there were no significant differences between groups .
-METHODS	Cardiovascular disease risk factors changed as expected from weight loss .
-CONCLUSIONS	Advice to consume 2 fish meals per week did not enhance the effects on weight loss of a healthy low calorie diet .
-BACKGROUND	ACTRN12608000425392 .
-
-###25462140
-OBJECTIVE	Repetitive transcranial magnetic stimulation ( rTMS ) has attracted attention as a putative clinical neuromodulatory tool , including for ameliorating hallucinations , although existing clinical data are inconsistent .
-OBJECTIVE	There is a notable paucity of research on its physiological effects on normal neuronal functioning .
-METHODS	We neuroimaged 24 healthy adult volunteers undertaking a variable loading passive auditory task , randomized into 2 matched and double-masked groups : half received a 17-minute 1 Hz right temporoparietal rTMS paradigm and half sham rTMS .
-RESULTS	One hertz rTMS led to attenuation of the underlying auditory cortex response to the stimulus and a contralateral increase in cortical activity .
-RESULTS	Subanalysis of the auditory tasks demonstrated that rTMS effects varied with stimulus frequency and differences between the active and sham conditions were lost at the highest frequency .
-CONCLUSIONS	This work is , to the best of our knowledge , the first to neuroimage the effects of a `` hallucinatory rTMS protocol '' on basic auditory processing in healthy controls .
-CONCLUSIONS	Our data demonstrated that a so-called `` inhibitory paradigm '' can also produce distal neuronal activation and that effects can vary with neural loading .
-CONCLUSIONS	These results highlight the insufficient knowledge of the effects of rTMS on normal physiology , and this , combined with a lack of consensus on clinical trial parameters , may be contributing to the ambivalent data in therapeutic trials .
-
-###24914549
-BACKGROUND	A Food and Drug Administration ( FDA ) safety communication in August 2011 warned that citalopram was associated with a dose dependent risk of QT prolongation and recommended dose restriction in patients over the age of 60 but did not provide data for this age group .
-METHODS	CitAD was a randomized , double-masked , placebo-controlled , multicenter clinical trial for agitation in Alzheimer 's disease ( AD ) .
-METHODS	Participants were assigned to citalopram ( target dose of 30 mg/day ) or placebo in a 1 1 ratio .
-METHODS	186 people , 181 of whom were over the age of 60 , having probable AD with clinically significant agitation were recruited from September 2009 to January 2013 .
-METHODS	After the FDA safety communication about citalopram , ECG was added to the required study procedures before enrollment and repeated at week 3 to monitor change in QTc interval .
-METHODS	Forty-eight participants were enrolled after enhanced monitoring began .
-RESULTS	Citalopram treatment was associated with a larger increase in QTc interval than placebo ( difference in week 3 QTc adjusting for baseline QTc : 18.1 ms [ 95 % CI : 6.1 , 30.1 ] ; p = 0.004 ) .
-RESULTS	More participants in the citalopram group had an increase 30 ms from baseline to week 3 ( 7 in citalopram versus 1 in placebo ; Fisher 's exact p = 0.046 ) , but only slightly more in the citalopram group met a gender-specific threshold for prolonged QTc ( 450 ms for males ; 470 ms for females ) at any point during follow-up ( 3 in citalopram versus 1 in placebo , Fisher 's exact p = 0.611 ) .
-RESULTS	One of the citalopram participants who developed prolonged QTc also displayed ventricular bigeminy .
-RESULTS	No participants in either group had a cardiovascular-related death .
-CONCLUSIONS	Citalopram at 30 mg/day was associated with improvement in agitation in patients with AD but was also associated with QT prolongation .
-BACKGROUND	ClinicalTrials.gov NCT00898807 .
-
-###24411709
-BACKGROUND	Creutzfeldt-Jakob disease ( CJD ) is a fatal , untreatable prion encephalopathy .
-BACKGROUND	Previous studies showed that doxycycline is effective in in-vitro and in-vivo models of disease , and patients with CJD who received compassionate treatment with doxycycline showed increased survival time compared with historical series .
-BACKGROUND	We therefore did a randomised , double-blind study of doxycycline versus placebo in CJD .
-METHODS	We recruited patients older than 18 years old who had a diagnosis of definite or probable sporadic CJD or genetic forms of the disease via Italian reference centres and the French national referral system .
-METHODS	Patients were randomly assigned ( ratio 1:1 ) to receive oral doxycycline ( 100 mg daily ) or placebo under double-blind conditions from the day of randomisation to death .
-METHODS	Centralised randomisation was done independently of enrolment or evaluation of patients using a minimisation method in Italy and a simple randomisation in France .
-METHODS	Participants , caregivers , and clinicians were masked to group assignment .
-METHODS	The primary efficacy variable was the survival time from randomisation .
-METHODS	Interim analyses were planned to detect a significant effect of treatment as early as possible .
-METHODS	This trial is registered with EudraCT , 2006-001858-27 for the Italian study and 2007-005553-34 for the French study .
-RESULTS	From April 12 , 2007 , to Aug 19 , 2010 , in Italy , and from Jan 30 , 2009 , to Jan 10 , 2012 , in France , 121 patients with CJD were enrolled in the study , 62 of whom were randomly assigned to the treatment group and 59 to the placebo group .
-RESULTS	The first interim analysis showed absence of superiority of doxycycline compared with placebo , and the trial was stopped for futility .
-RESULTS	Efficacy analyses did not show significant differences between patients treated with doxycycline and placebo with regard to survival times ( HR 1.1 , 95 % CI 0.8-1 .7 , p = 0.50 ) .
-RESULTS	Serious adverse events were judged not to be related to treatment , whereas a relation was deemed probable or possible for five non-serious adverse events that occurred in each treatment group .
-CONCLUSIONS	Doxycycline at a dose of 100 mg per day was well tolerated but did not significantly affect the course of CJD , at variance with the results of previous observational studies .
-CONCLUSIONS	Our experience could be useful in the design of large multinational controlled trials of potential anti-prion molecules in this rare disease .
-BACKGROUND	Agenzia Italiana Farmaco , Italian Ministry of Health , AIEnP , and French Ministry of Health .
-
-###25548978
-BACKGROUND	The prevalence of sexual dysfunction , low vitality , and poor physical function increases with aging , as does the prevalence of low total and free testosterone ( TT and FT ) levels .
-BACKGROUND	However , the relationship between sex hormones and age-related alterations in older men is not clear .
-OBJECTIVE	To test the hypotheses that baseline serum TT , FT , estradiol ( E2 ) , and sex hormone-binding globulin ( SHBG ) levels are independently associated with sexual function , vitality , and physical function in older symptomatic men with low testosterone levels participating in the Testosterone Trials ( TTrials ) .
-METHODS	Cross-sectional study of baseline measures in the TTrials .
-METHODS	The study was conducted at 12 sites in the United States .
-METHODS	The 788 TTrials participants were 65 years and had evidence of sexual dysfunction , diminished vitality , and/or mobility disability , and an average of two TT < 275 ng/dL .
-METHODS	None .
-METHODS	Question 4 of Psychosocial Daily Questionnaire ( PDQ-Q4 ) , the FACIT-Fatigue Scale , and the 6-minute walk test .
-RESULTS	Baseline serum TT and FT , but not E2 or SHBG levels had small , but statistically significant associations with validated measures of sexual desire , erectile function , and sexual activity .
-RESULTS	None of these hormones was significantly associated within or across trials with FACIT-Fatigue , PHQ-9 Depression or Physical Function-10 scores , or gait speed .
-CONCLUSIONS	FT and TT levels were consistently , independently , and positively associated , albeit to a small degree , with measures of sexual desire , erectile function , and sexual activity , but not with measures of vitality or physical function in symptomatic older men with low T who qualified for the TTrials .
-
-###25631723
-OBJECTIVE	Biopure MTAD , a new root canal irrigant has shown promising results against the most common resistant microorganism , E. faecalis , in permanent teeth .
-OBJECTIVE	However , there is lack of studies comparing its antimicrobial effectiveness with NaOCl in primary teeth .
-OBJECTIVE	The purpose of this study was to compare the in vivo antimicrobial efficacy of NaOCl 2.5 % and Biopure MTAD against E. faecalis in primary teeth .
-METHODS	Forty non vital single rooted primary maxillary anterior teeth of children aged 4-8 years , were irrigated either with NaOCl 2.5 % ( n = 15 ) , Biopure MTAD ( n = 15 ) and 0.9 % Saline ( n = 10 , control group ) .
-METHODS	Paper point samples were collected at baseline ( S1 ) and after chemomechanical preparation ( S2 ) during the pulpectomy procedure .
-METHODS	The presence of E. faecalis in S1 & S2 was evaluated using Real time Polymerase Chain Reaction .
-RESULTS	Statistical significant difference was found in the antimicrobial efficacy of NaOCl 2.5 % and BioPure MTAD when compared to saline ( p > 0.05 ) .
-RESULTS	However , no statistical significant difference was found between the efficacies of both the irrigants .
-CONCLUSIONS	NaOCl 2.5 % and BioPure MTAD , both irrigants are equally efficient against E. faecalis in necrotic primary anterior teeth .
-CONCLUSIONS	MTAD is a promising irrigant , however clinical studies are required to establish it as ideal root canal irrigant in clinical practice .
-
-###24732081
-OBJECTIVE	To compare 24-month pulp health outcomes of partial caries removal ( PCR ) and total caries removal ( TCR ) with composite restoration in primary molars .
-METHODS	48 children aged 3-8 years with at least one molar with a deep carious lesion were included .
-METHODS	120 teeth were randomized to control ( TCR ; n = 54 ; 69 % class II ) and test ( PCR ; n = 66 ; 63 % class II ) groups .
-METHODS	Total absence of carious tissue was confirmed using a blunt-tipped probe in the TCR group .
-METHODS	For PCR , excavation was stopped when hardened , dried dentin with a leathery consistency was achieved .
-METHODS	Pulpotomy was performed in cases of pulp exposure .
-RESULTS	Pulp exposure occurred in 2 and 27.5 % of teeth treated with PCR and TCR , respectively ( p < 0.01 ) .
-RESULTS	The operative time was significantly higher for TCR than PCR .
-RESULTS	Success rates were 92 and 96 % in the PCR and TCR groups , respectively ( p = 0.34 ) .
-RESULTS	The success rate tended to be lower in occlusoproximal ( 92 % ) than in occlusal ( 100 % ) lesions ( p = 0.08 ) .
-CONCLUSIONS	The clinical and radiographic success rates of PCR and TCR in primary teeth with deep carious lesions were high and did not differ significantly , indicating that PCR is a reliable minimally invasive approach in primary teeth and that the retention of carious dentin does not interfere with pulp vitality .
-CONCLUSIONS	Moreover , PCR provided other clinically relevant advantages over TCR , especially lower incidence of pulp exposure and lower operative time .
-
-###25512466
-OBJECTIVE	To determine whether maternal allopurinol treatment during suspected fetal hypoxia would reduce the release of biomarkers associated with neonatal brain damage .
-METHODS	A randomised double-blind placebo controlled multicentre trial .
-METHODS	We studied women in labour at term with clinical indices of fetal hypoxia , prompting immediate delivery .
-METHODS	Delivery rooms of 11 Dutch hospitals .
-METHODS	When immediate delivery was foreseen based on suspected fetal hypoxia , women were allocated to receive allopurinol 500 mg intravenous ( ALLO ) or placebo intravenous ( CONT ) .
-METHODS	Primary endpoint was the difference in cord S100 , a tissue-specific biomarker for brain damage .
-RESULTS	222 women were randomised to receive allopurinol ( ALLO , n = 111 ) or placebo ( CONT , n = 111 ) .
-RESULTS	Cord S100 was not significantly different between the two groups : 44.5 pg/mL ( IQR 20.2-71 .4 ) in the ALLO group versus 54.9 pg/mL ( IQR 26.8-94 .7 ) in the CONT group ( difference in median -7.69 ( 95 % CI -24.9 to 9.52 ) ) .
-RESULTS	Post hoc subgroup analysis showed a potential treatment effect of allopurinol on the proportion of infants with a cord S100 value above the 75th percentile in girls ( ALLO n = 5 ( 12 % ) vs CONT n = 10 ( 31 % ) ; risk ratio ( RR ) 0.37 ( 95 % CI 0.14 to 0.99 ) ) but not in boys ( ALLO n = 18 ( 32 % ) vs CONT n = 15 ( 25 % ) ; RR 1.4 ( 95 % CI 0.84 to 2.3 ) ) .
-RESULTS	Also , cord neuroketal levels were significantly lower in girls treated with allopurinol as compared with placebo treated girls : 18.0 pg/mL ( 95 % CI 12.1 to 26.9 ) in the ALLO group versus 32.2 pg/mL ( 95 % CI 22.7 to 45.7 ) in the CONT group ( geometric mean difference -16.4 ( 95 % CI -24.6 to -1.64 ) ) .
-CONCLUSIONS	Maternal treatment with allopurinol during fetal hypoxia did not significantly lower neuronal damage markers in cord blood .
-CONCLUSIONS	Post hoc analysis revealed a potential beneficial treatment effect in girls .
-BACKGROUND	NCT00189007 , Dutch Trial Register NTR1383 .
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-###24419306
-OBJECTIVE	This randomized trial evaluated the therapeutic effect of emotional awareness training on the severity and frequency of pain in patients with irritable bowel syndrome ( IBS ) .
-OBJECTIVE	Patients ' level of alexithymia was also measured .
-METHODS	The study involved 100 patients diagnosed with IBS according to the Rome-III criteria .
-METHODS	Patients ' mean age was 34.98 years ( standard deviation 10.22 years ) and 60 % of the patients were female .
-METHODS	Seventy eligible patients were assigned randomly to one of two treatment groups .
-METHODS	One group received standard symptom-oriented medical treatment only ( MT group ) , while the second group , termed the emotional awareness group ( EMT ) , was educated to increase conscious awareness of eight primary emotions in addition to receiving standard symptom-oriented medical treatment .
-METHODS	This study was conducted over 20 months .
-METHODS	All patients received 5 weeks of symptom-oriented medical treatment ; patients in the EMT group also had two emotion awareness training sessions and recorded their emotions in a daily diary .
-METHODS	Sixty patients completed the study .
-RESULTS	Patients with IBS scored significantly higher on all aspects of alexithymia compared with healthy controls .
-RESULTS	The severity of pain decreased significantly in both groups , with a larger percentage of the patients in the EMT group who completed the study having a significant decrease in pain ( 54 % in the EMT group vs. 36 % in the MT group ) ; this finding was replicated in an intent-to-treat analysis .
-RESULTS	The same results were observed for frequency of pain in patients who completed the study ( 59 % in the EMT group vs 43.4 % in the MT group ) , but this finding was not replicated in an intent-to-treat analysis .
-RESULTS	These patterns were not influenced by level of alexithymia , age , or gender .
-CONCLUSIONS	Adding emotional awareness training to medical treatment resulted in a better therapeutic response in abdominal pain in patients with IBS .
-
-###25186158
-BACKGROUND	Despite therapeutic advances , many people with type 1 diabetes are still unable to achieve optimal glycaemic control , limited by the occurrence of hypoglycaemia .
-BACKGROUND	The objective of the present study is to determine the effectiveness of day and night home closed-loop over the medium term compared with sensor-augmented pump therapy in adults with type 1 diabetes and suboptimal glycaemic control .
-METHODS	The study will adopt an open label , three-centre , multinational , randomised , two-period crossover study design comparing automated closed-loop glucose control with sensor augmented insulin pump therapy .
-METHODS	The study will aim for 30 completed participants .
-METHODS	Eligible participants will be adults ( 18years ) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control ( glycated haemoglobin ( HbA1c ) 7.5 % ( 58mmol/mmol ) and 10 % ( 86mmol/mmol ) ) .
-METHODS	Following a 4-week optimisation period , participants will undergo a 3-month use of automated closed-loop insulin delivery and sensor-augmented pump therapy , with a 4-6week washout period in between .
-METHODS	The order of the interventions will be random .
-METHODS	All analysis will be conducted on an intention to treat basis .
-METHODS	The primary outcome is the time spent in the target glucose range from 3.9 to 10.0 mmol/L based on continuous glucose monitoring levels during the 3months free living phase .
-METHODS	Secondary outcomes include HbA1c changes ; mean glucose and time spent above and below target glucose levels .
-METHODS	Further , participants will be invited at baseline , midpoint and study end to participate in semistructured interviews and complete questionnaires to explore usability and acceptance of the technology , impact on quality of life and fear of hypoglycaemia .
-BACKGROUND	Ethical approval has been obtained at all sites .
-BACKGROUND	Before screening , all participants will be provided with oral and written information about the trial .
-BACKGROUND	The study will be disseminated by peer-review publications and conference presentations .
-BACKGROUND	NCT01961622 ( ClinicalTrials.gov ) .
-
-###24275625
-OBJECTIVE	Evaluating the impact of splitting toric power on patient tolerance to misorientation such as with intraocular lens rotation .
-METHODS	University vision clinic .
-METHODS	Healthy , non astigmats had +1.50 D astigmatism induced with spectacle lenses at 90 , 135 , 180 and +3.00 D at 90 .
-METHODS	Two correcting cylindrical lenses of the opposite sign and half the power each were subsequently added to the trial frame misaligned by 0 , 5 or 10 in a random order and misorientated from the initial axis in a clockwise direction by up to 15 in 5 steps .
-METHODS	A second group of adapted astigmats with between 1.00 and 3.00 DC had their astigmatism corrected with two toric spectacle lenses of half the power separated by 0 , 5 or 10 and misorientated from the initial axis in both directions by up to 15 in 5 steps .
-METHODS	Distance , high contrast visual acuity was measured using a computerised test chart at each lens misalignment and misorientation .
-RESULTS	Misorientation of the split toric lenses caused a statistically significant drop in visual acuity ( F = 70.341 ; p < 0.001 ) .
-RESULTS	Comparatively better acuities were observed around 180 , as anticipated ( F = 3.775 ; p = 0.035 ) .
-RESULTS	Misaligning the split toric power produced no benefit in visual acuity retention with axis misorientation when subjects had astigmatism induced with a low ( F = 2.190 , p = 0.129 ) or high cylinder ( F = 0.491 , p = 0.617 ) or in the adapted astigmats ( F = 0.120 , p = 0.887 ) .
-CONCLUSIONS	Misalignment of toric lens power split across the front and back lens surfaces had no beneficial effect on distance visual acuity , but also no negative effect .
-
-###24339310
-OBJECTIVE	This study investigated whether hormones and pain perception are associated with exam anxiety , and also whether exam anxiety is affected by seasonal differences in testosterone and cortisol levels .
-METHODS	Forty-six healthy males were recruited from a medical college .
-METHODS	Anxiety was induced by having participants perform the Objective Structured Clinical Examination .
-METHODS	Pressure was applied to the participants to induce pain .
-METHODS	Pain thresholds , pain ratings , anxiety ratings , blood pressure , heart rate , salivary testosterone and cortisol levels were measured under resting and anxiety conditions in the spring and summer .
-METHODS	Data were collected from 46 participants during the spring ( n = 25 ) and summer ( n = 21 ) .
-RESULTS	Pain thresholds and testosterone levels were significantly lower under anxiety than at rest for all participants ( n = 46 ) , while cortisol levels , pain ratings , and anxiety ratings were significantly higher under anxiety than at rest .
-RESULTS	In the spring ( n = 25 ) , testosterone levels were significantly higher at rest than under anxiety , while there was no difference in cortisol levels between resting and anxiety conditions .
-RESULTS	In the summer ( n = 21 ) , cortisol levels were significantly higher under anxiety than at rest , while there was no difference in testosterone levels between resting and anxiety conditions .
-RESULTS	There were no significant seasonal differences in pain and anxiety ratings and pain threshold .
-CONCLUSIONS	These results indicate that seasonal differences in testosterone and cortisol levels under anxiety and at rest may affect pain responses .
-CONCLUSIONS	These results also suggest that acute clinical pain may be relieved by managing anxiety that is related to a decrease of testosterone in spring and a large increase of cortisol in summer .
-
-###25677679
-BACKGROUND	QVA149 is a once-daily ( o.d. ) inhaled dual bronchodilator containing a fixed-dose combination of the long-acting 2-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium for the treatment of COPD .
-BACKGROUND	The QUANTIFY study compared QVA149 with a free-dose bronchodilator combination of tiotropium plus formoterol ( TIO+FOR ) in improving health-related quality of life ( HRQoL ) of patients with COPD .
-METHODS	This multicentre , blinded , triple-dummy , parallel-group , non-inferiority study randomised patients aged 40years with moderate-to-severe COPD ( post-bronchodilator forced expiratory volume in 1s ( FEV1 ) 30 % to < 80 % predicted ) to QVA149 110/50g o.d. or TIO 18g o.d. + FOR 12g twice daily ( 1:1 ) for 26weeks .
-METHODS	The primary endpoint was to demonstrate non-inferiority in HRQoL assessed using St George 's Respiratory Questionnaire-COPD ( SGRQ-C ) .
-METHODS	The prespecified non-inferiority margin was 4 units .
-METHODS	Secondary endpoints included Transition Dyspnoea Index ( TDI ) score , pre-dose FEV1 , forced vital capacity ( FVC ) and safety .
-RESULTS	Of the 934 patients randomised ( QVA149 = 476 and TIO+FOR = 458 ) , 87.9 % completed the study .
-RESULTS	At week 26 , non-inferiority was met for SGRQ-C ( QVA149 vs TIO+FOR ; difference : -0.69 units ; 95 % CI -2.31 to 0.92 ; p = 0.399 ) .
-RESULTS	A significantly higher percentage of patients achieved a clinically relevant 1 point improvement in TDI total score with QVA149 ( 49.6 % ) versus TIO+FOR ( 42.4 % ; p = 0.033 ) .
-RESULTS	QVA149 significantly increased pre-dose FEV1 ( +68 mL , 95 % CI 37mL to 100mL ; p < 0.001 ) and FVC ( +74 mL , 95 % CI 24mL to 125mL ; p = 0.004 ) compared with TIO+FOR at week 26 .
-RESULTS	The incidence of adverse events was comparable between both treatments ( QVA149 = 43.7 % and TIO+FOR = 42.6 % ) .
-CONCLUSIONS	QVA149 is non-inferior to TIO+FOR in improving HRQoL , with clinically meaningful and significant improvements in breathlessness and lung function in patients with COPD .
-BACKGROUND	NCT01120717 .
-
-###25337749
-BACKGROUND	Tuberculosis regimens that are shorter and simpler than the current 6-month daily regimen are needed .
-METHODS	We randomly assigned patients with newly diagnosed , smear-positive , drug-sensitive tuberculosis to one of three regimens : a control regimen that included 2 months of ethambutol , isoniazid , rifampicin , and pyrazinamide administered daily followed by 4 months of daily isoniazid and rifampicin ; a 4-month regimen in which the isoniazid in the control regimen was replaced by moxifloxacin administered daily for 2 months followed by moxifloxacin and 900 mg of rifapentine administered twice weekly for 2 months ; or a 6-month regimen in which isoniazid was replaced by daily moxifloxacin for 2 months followed by one weekly dose of both moxifloxacin and 1200 mg of rifapentine for 4 months .
-METHODS	Sputum specimens were examined on microscopy and after culture at regular intervals .
-METHODS	The primary end point was a composite treatment failure and relapse , with noninferiority based on a margin of 6 percentage points and 90 % confidence intervals .
-RESULTS	We enrolled a total of 827 patients from South Africa , Zimbabwe , Botswana , and Zambia ; 28 % of patients were coinfected with the human immunodefiency virus .
-RESULTS	In the per-protocol analysis , the proportion of patients with an unfavorable response was 4.9 % in the control group , 3.2 % in the 6-month group ( adjusted difference from control , -1.8 percentage points ; 90 % confidence interval [ CI ] , -6.1 to 2.4 ) , and 18.2 % in the 4-month group ( adjusted difference from control , 13.6 percentage points ; 90 % CI , 8.1 to 19.1 ) .
-RESULTS	In the modified intention-to-treat analysis these proportions were 14.4 % in the control group , 13.7 % in the 6-month group ( adjusted difference from control , 0.4 percentage points ; 90 % CI , -4.7 to 5.6 ) , and 26.9 % in the 4-month group ( adjusted difference from control , 13.1 percentage points ; 90 % CI , 6.8 to 19.4 ) .
-CONCLUSIONS	The 6-month regimen that included weekly administration of high-dose rifapentine and moxifloxacin was as effective as the control regimen .
-CONCLUSIONS	The 4-month regimen was not noninferior to the control regimen .
-CONCLUSIONS	( Funded by the European and Developing Countries Clinical Trials Partnership and the Wellcome Trust ; RIFAQUIN Current Controlled Trials number , ISRCTN44153044 . )
-
-###25261913
-BACKGROUND	Treatment for displaced proximal humeral fractures is still under debate .
-BACKGROUND	Few studies exist at the highest level of evidence .
-BACKGROUND	Although reversed total shoulder prosthesis has gained popularity and showed promising results in the treatment for proximal humeral fractures in the elderly patients , no randomized controlled trials exist to the authors ' knowledge .
-METHODS	This study is a randomized semi-blinded controlled multicenter trial designed according to the Consort statement and the recommendations given by the Cochrane reviewers for proximal humeral fractures .
-METHODS	The study will investigate whether a reversed total shoulder prosthetic replacement gain better functional outcome compared to open reduction and internal fixation using an angular stable plate in displaced three - and four parts proximal humeral fractures after two and five years follow-up .
-METHODS	Participants are aged 65-85 admitted in seven different hospitals with a displaced proximal humeral fracture according to AO-OTA type 11-B2 or 11-C2 .
-METHODS	The intervention group is surgical treatment using a reversed total shoulder prosthesis ( Delta X-tend ) compared to open reduction and internal fixation with an angular stable plate ( Philos ) and thread cerclage in the control group .
-METHODS	60 patients will be randomized to each group.The primary outcome is shoulder function ( Constant score ) .
-METHODS	Secondary outcomes will be patient self-assessment form ( Oxford shoulder score ) , a quality of life questionnaire ( 15D score ) and resource implications ( cost-effectiveness ) .
-METHODS	Follow-ups take place at 3 , 6 , 12 and 24 months , and five years .
-METHODS	The trial design is semi-blinded with blinded physiotherapists performing the functional testing of patients at all follow-ups .
-METHODS	Randomization to treatment groups is electronic online , by independent supervisor ( web-CRF ) .
-METHODS	The recruitment of patients started at January 1 .
-METHODS	st 2013 .
-METHODS	Inclusion of 120 patients during three years is expected .
-CONCLUSIONS	This semiblinded trial include a high number of patients compared to existing randomized trials in this field .
-CONCLUSIONS	To our knowledge and according to ClinicalTrials.gov , this is the first study that compare these two treatments for a displaced proximal humeral fracture in elderly patients .
-CONCLUSIONS	This may provide important information to help the surgeon to decide the best treatment in the future .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT01737060 .
-
-###25482467
-BACKGROUND	Increasing ambient temperature to prevent intraoperative patient hypothermia remains widely advocated despite unconvincing evidence of efficacy .
-BACKGROUND	Heat stress is associated with decreased cognitive and psychomotor performance across multiple tasks but remains unexamined in an operative context .
-BACKGROUND	We assessed the impact of increased ambient temperature on laparoscopic operative performance and surgeon cognitive stress .
-METHODS	Forty-two performance measures were obtained from 21 surgery trainees participating in the counter-balanced , within-subjects study protocol .
-METHODS	Operative performance was evaluated with adaptations of the validated , peg-transfer , and intracorporeal knot-tying tasks from the Fundamentals of Laparoscopic Surgery program .
-METHODS	Participants trained to proficiency before enrollment .
-METHODS	Task performance was measured at two ambient temperatures , 19 and 26C ( 66 and 79F ) .
-METHODS	Participants were randomly counterbalanced to initial hot or cold exposure before crossing over to the alternate environment .
-METHODS	Cognitive stress was measured using the validated Surgical Task Load Index ( SURG-TLX ) .
-RESULTS	No differences in performance of the peg-transfer and intracorporeal knot-tying tasks were seen across ambient conditions .
-RESULTS	Assessed via use of the six bipolar scales of the SURG-TLX , we found differences in task workload between the hot and cold conditions in the areas of physical demands ( hot 10 [ 3-12 ] , cold 5 [ 2.5-9 ] , P = .013 ) and distractions ( hot 8 [ 3.5-15 .5 ] , cold 3 [ 1.5-5 .5 ] , P = .001 ) .
-RESULTS	Participant perception of distraction remained greater in the hot condition on full scoring of the SURG-TLX .
-CONCLUSIONS	Increasing ambient temperature to levels advocated for prevention of intraoperative hypothermia does not greatly decrease technical performance in short operative tasks .
-CONCLUSIONS	Surgeons , however , do report increased perceptions of distraction and physical demand .
-CONCLUSIONS	The impact of these findings on performance and outcomes during longer operative procedures remains unclear .
-
-###25972515
-OBJECTIVE	This exploratory trial was performed to determine whether Daikenchuto accelerates recovery of gastrointestinal function in patients undergoing open colectomy for colon cancer .
-METHODS	A total of 386 patients undergoing colectomy at 1 of the 51 clinical trial sites in Japan from January 2009 to June 2011 were registered for the study ( JFMC39-0902 ) .
-METHODS	Patients received either placebo or Daikenchuto ( 15.0 g/day , t.i.d ) between post-operative day 2 and post-operative day 8 .
-METHODS	Primary end-points included time to first bowel movement , frequency of bowel movement and stool form .
-METHODS	The incidence of intestinal obstruction was evaluated post-operatively .
-METHODS	The safety profile of Daikenchuto until post-operative day 8 was also evaluated .
-RESULTS	The results for 336 patients ( Daikenchuto , n = 174 ; placebo , n = 162 ) were available for statistical analysis .
-RESULTS	The time to first bowel movement did not differ significantly between the two groups .
-RESULTS	All patients reported having diarrhea or soft stools immediately after surgery , and the time until stool normalization ( 50th percentile ) in the Daikenchuto and placebo groups was 6 days and 7 days , respectively .
-RESULTS	The placebo group had a significantly greater number of hard stools at post-operative day 8 ( P = 0.016 ) , and bowel movement frequency continued to increase until post-operative day 8 as well .
-RESULTS	In contrast , bowel movement frequency in the Daikenchuto group increased until post-operative day 6 , however decreased from post-operative day 7 and was significantly lower at post-operative day 8 compared with the placebo group ( P = 0.024 ) .
-CONCLUSIONS	The moderate effects of Daikenchuto were observed 1 week after the operation .
-CONCLUSIONS	Although Daikenchuto had an effect on gastrointestinal function after open surgery in patients with colon cancer , this study did not show its clinical benefits adequately .
-
-###25060955
-BACKGROUND	Little information exists about the role of fear-avoidance beliefs and catastrophizing in subacromial pain syndrome .
-OBJECTIVE	The purpose of this study was to investigate the associations among pain , catastrophizing , fear , and disability and the contribution of fear-avoidance beliefs to disability at baseline and at 3-month follow-up .
-METHODS	A cross-sectional and longitudinal analysis was conducted .
-METHODS	Baseline demographic and clinical data , including fear-avoidance beliefs and catastrophizing , of 90 patients were assessed for this analysis .
-METHODS	Disability was measured with the Shoulder Pain and Disability Index at baseline and at 3-month follow-up .
-METHODS	First , bivariate and partial correlations were calculated among pain , fear-avoidance beliefs , catastrophizing , and disability , based on the fear-avoidance model .
-METHODS	Second , the contribution of fear-avoidance beliefs to disability at baseline and at 3-month follow-up was examined with hierarchical regression analyses .
-RESULTS	Correlations between clinical variables and disability were largely in line with the fear-avoidance model .
-RESULTS	Regression analyses identified a significant contribution of fear-avoidance beliefs to baseline disability but not to disability at 3 months .
-CONCLUSIONS	Patients with subacromial pain syndrome were studied ; therefore , the results should be transferred with caution to other diagnoses .
-CONCLUSIONS	A modified version of the Fear-Avoidance Beliefs Questionnaire was used , which was not validated for this patient group .
-CONCLUSIONS	Fear-avoidance beliefs contribute significantly to baseline disability but not to disability change scores after 3-month follow-up .
-CONCLUSIONS	Duration of complaints and baseline disability were the main factors influencing disability change scores .
-CONCLUSIONS	Although the results help to improve understanding of the role of fear-avoidance beliefs , further studies are needed to fully understand the influence of psychological and clinical factors on the development of disability in patients with subacromial shoulder pain .
-
-###25110339
-BACKGROUND	Several publications have suggested that induction chemotherapy followed by extrapleural pneumonectomy ( EPP ) for patients with malignant pleural mesothelioma ( MPM ) patients is associated with exceedingly high morbidity and mortality , and the role of EPP is controversially debated .
-BACKGROUND	The present retrospective study analyzed the perioperative outcome in 251 consecutively treated patients at three high-volume mesothelioma centers .
-METHODS	251 MPM patients completed EPP after platinum-based induction chemotherapy at three institutions for thoracic surgery over more than 10 years .
-METHODS	The rates of 30-day and 90-day mortality and of major morbidities ( pulmonary embolism , postoperative bleeding , acute respiratory distress syndrome , empyema , bronchopleural fistula ( BPF ) , chylothorax , patch failure ) were recorded .
-METHODS	Perioperative outcome was correlated to risk factors such as smoking history ( pack years ) , age at operation , body mass index , spirometry results , C-reactive protein , American Society of Anesthesiologists classification , chemotherapy regimen used , blood loss during operation , duration of operation , and characteristics of the tumor ( laterality , histologic subtype , pT and pN stage ) to find factors predicting 30-day and 90-day mortality or major morbidity .
-RESULTS	The overall 30-day mortality was 5 % .
-RESULTS	Within 90 days after operation , 8 % of the patients died .
-RESULTS	The rates of 30-day and 90-day mortality were significantly higher in patients with high preoperative C-reactive protein values ( p = 0.001 and p < 0.0005 ) .
-RESULTS	The spirometry values forced expiratory volume in 1 second and forced vital capacity exhaled ( FVCex ) were both associated with 30-day and 90-day mortality ( p = 0.001 and p < 0.0005 ; and p = 0.002 and p < 0.0005 ) .
-RESULTS	Major morbidity occurred in 30 % of the patients , significantly more often after right-sided EPP ( p = 0.01 ) and after longer operations ( p < 0.0005 ) .
-RESULTS	Empyema ( p < 0.0005 ) and acute respiratory distress syndrome ( p = 0.02 ) were associated with longer duration of operation .
-CONCLUSIONS	EPP after induction chemotherapy is a demanding procedure but can be performed with acceptable morbidity and mortality if patients are well selected and treated at dedicated high-volume MPM centers .
-
-###25473191
-OBJECTIVE	To investigate the efficacy of lubiprostone compared to Senna on bowel symptoms and constipation in post-operative orthopedic patients treated with opioids .
-METHODS	In this double blind , randomized , active comparator trial , adults who required opioids for analgesia following orthopedic procedures and who were admitted in inpatient rehabilitation were randomized following baseline assessments to lubiprostone ( Amitza ( ) ) , orally twice a day or Senna ( generic ) two capsules administered daily for six days .
-METHODS	Subjects were assessed using the patient assessment of constipation ( PAC ) - symptoms ( PAC-SYM ) and the PAC-quality of life ( PAC-QOL ) scales measured at baseline and Day 7 ; Subjects were assessed daily for secondary measures included the Bristol stool scale bowel consistency , specific bowel symptom score ( Nausea , cramping , straining , completeness , abdominal pain , time per lavatory attempt , assistance needed ) , adverse events and rescue medications required .
-METHODS	Function was measured using the functional independence measure ( FIM ) at admission and discharge ; length of stay ( LOS ) and missed treatments due to gastrointestinal symptoms were also assessed .
-RESULTS	64 adults were enrolled ; 56 participants ( 28 in each group ) had baseline and follow up measures and were included in the intention to treat ( ITT ) analyses .
-RESULTS	43 participants completed the study , 21 in the active lubiprostone and 22 in the active Senna group .
-RESULTS	The mean age of the participants was 71.5 years ( SD = 11.4 years , range : 28-96 years ) .
-RESULTS	In the ITT analyses , participants showed significant improvement in bowel symptoms as measured by the PAC-SYM ( mean SD , -0.28 0.60 , range : -1 -2.33 ) and PAC-QOL ( mean SD , 0.33 0.81 , range : -1.5 -2.0 ) over time , but there were no significant differences between the lubiprostone and Senna groups in mean change in the PAC-SYM ( -0.20 0.60 vs -0.36 0.61 , P = 0.61 respectively ) or the PAC-QOL ( 0.29 0.76 vs 0.37 0.87 , P = 0.61 respectively ) .
-RESULTS	The mean change in each bowel symptom also did not significantly differ between treatment groups on ITT analyses , except for completeness of bowel movement , with the Senna group showing greater negative mean change in bowel movement completeness ( -0.56 1.01 vs -2.00 1.41 , P = 0.03 ) and for reduction of abdominal pain , favoring Senna ( -0.14 0.73 vs -0.73 1.08 , P = 0.04 ) .
-RESULTS	Fifteen ( 75 % ) participants in the lubiprostone and in the Senna group requested rescue treatments .
-RESULTS	Participants made significant functional improvement from admission to discharge over a median LOS of 12 d , with a mean FIM change of 29.13 13.58 and no significant between group differences ( 27.0 9.2 vs 31.5 16.6 , P = 0.27 ) .
-CONCLUSIONS	Both lubiprostone and Senna improved constipation-related symptoms and QOL in opioid-induced constipation , with no significant between-group differences .
-
-###24668103
-OBJECTIVE	Unhealthy alcohol use is a leading contributor to the global burden of disease , particularly among young people .
-OBJECTIVE	Systematic reviews suggest efficacy of web-based alcohol screening and brief intervention and call for effectiveness trials in settings where it could be sustainably delivered .
-OBJECTIVE	To evaluate a national web-based alcohol screening and brief intervention program .
-METHODS	A multisite , double-blind , parallel-group , individually randomized trial was conducted at 7 New Zealand universities .
-METHODS	In April and May of 2010 , invitations containing hyperlinks to the Alcohol Use Disorders Identification Test-Consumption ( AUDIT-C ) screening test were e-mailed to 14,991 students aged 17 to 24 years .
-METHODS	Participants who screened positive ( AUDIT-C score 4 ) were randomized to undergo screening alone or to 10 minutes of assessment and feedback ( including comparisons with medical guidelines and peer norms ) on alcohol expenditure , peak blood alcohol concentration , alcohol dependence , and access to help and information .
-METHODS	A fully automated 5-month follow-up assessment was conducted that measured 6 primary outcomes : consumption per typical occasion , drinking frequency , volume of alcohol consumed , an academic problems score , and whether participants exceeded medical guidelines for acute harm ( binge drinking ) and chronic harm ( heavy drinking ) .
-METHODS	A Bonferroni-corrected significance threshold of .0083 was used to account for the 6 comparisons and a sensitivity analysis was used to assess possible attrition bias .
-RESULTS	Of 5135 students screened , 3422 scored 4 or greater and were randomized , and 83 % were followed up .
-RESULTS	There was a significant effect on 1 of the 6 prespecified outcomes .
-RESULTS	Relative to control participants , those who received intervention consumed less alcohol per typical drinking occasion ( median 4 drinks [ interquartile range { IQR } , 2-8 ] vs 5 drinks [ IQR 2-8 ] ; rate ratio [ RR ] , 0.93 [ 99.17 % CI , 0.86-1 .00 ] ; P = .005 ) but not less often ( RR , 0.95 [ 99.17 % CI , 0.88-1 .03 ] ; P = .08 ) or less overall ( RR , 0.95 [ 99.17 % CI , 0.81-1 .10 ] ; P = .33 ) .
-RESULTS	Academic problem scores were not lower ( RR , 0.91 [ 99.17 % CI , 0.76-1 .08 ] ; P = .14 ) and effects on the risks of binge drinking ( odds ratio [ OR ] , 0.84 [ 99.17 % CI , 0.67-1 .05 ] ; P = .04 ) and heavy drinking ( OR , 0.77 [ 99.17 % CI , 0.56-1 .05 ] ; P = .03 ) were not significantly significant .
-RESULTS	In a sensitivity analysis accounting for attrition , the effect on alcohol per typical drinking occasion was no longer statistically significant .
-CONCLUSIONS	A national web-based alcohol screening and brief intervention program produced no significant reductions in the frequency or overall volume of drinking or academic problems .
-CONCLUSIONS	There remains a possibility of a small reduction in the amount of alcohol consumed per typical drinking occasion .
-BACKGROUND	anzctr.org.au Identifier : ACTRN12610000279022 .
-
-###24761877
-BACKGROUND	To evaluate efficacy and side effects of glycididazole sodium ( CMNa ) combined with chemotherapy ( cisplatin plus 5-FU/folic acid , PLF ) and radiotherapy in treating patients with locally advanced nasopharyngeal carcinoma .
-METHODS	Patients with III ~ IV stage nasopharyngeal carcinoma ( NPC ) , were randomly divided into treatment group ( 46 patients ) and control group ( 45 patients ) .
-METHODS	Both groups received radiotherapy concomitant with PLF chemotherapy .
-METHODS	The treatment group at the same time was given CMNa ( 800 mg/m2 before radiotherapy ) , by l h intravenous drip , three times a week .
-RESULTS	When the dose of radiation was over 60 Gy , complete response rates of nasopharyngeal tumor and lymph node metastases in treatment group were significantly higher than in the control group ( 93.5 % vs 77.8 % ; 89.1 % vs 93.5 % , p < 0.05 ) .
-RESULTS	Three months after radiotherapy , complete response rate of nasopharynx cancer and lymph node metastases in treatment group was both 97.8 % , again higher than in the control group ( 84.4 % and 82.2 % ) ( p < 0.05 ) .
-RESULTS	In the treatment group , 1 , 3 , 5 year disease-free survival rates were 95.7 % , 86.7 % and 54.5 % ; and in control group , the corresponding disease-free survival rates were 93.3 % , 66.2 % and 38.6 % , respectively , the difference being statistically significant ( log-rank = 5.887 , p = 0.015 ) .
-RESULTS	One , 3 , 5 year overall survival rates in two groups of patients were 97.8 % , 93.5 % , 70.4 % and 95.5 % , 88.07 % , 48.4 % , respectively , again with a statistically significant difference ( log-rank = 6.470 , p = 0.011 ) .
-RESULTS	Acute toxicity and long-term radiotherapy related toxicity in the two groups did not differ ( p > 0.05 ) .
-CONCLUSIONS	Glycididazole sodium could improve curative effects without increasing adverse reactions when treating patients with locally advanced nasopharyngeal carcinoma .
-
-###24886555
-BACKGROUND	Guided self-help is a recommended first-step treatment for bulimia nervosa , binge eating disorder and atypical variants of these disorders .
-BACKGROUND	Further research is needed to compare guided self-help that is delivered face-to-face versus via email .
-METHODS	This clinical trial uses a randomised , controlled design to investigate the effectiveness of providing guided self-help either face-to-face or via e-mail , also using a delayed treatment control condition .
-METHODS	At least 17 individuals are required per group , giving a minimum N of 51 .
-CONCLUSIONS	Symptom outcomes will be assessed and estimates of cost-effectiveness made .
-CONCLUSIONS	Results are proposed to be disseminated locally and internationally ( through submission to conferences and peer-reviewed journals ) , and will hopefully inform local service provision .
-CONCLUSIONS	The trial has been approved by an ethics review board and was registered with ClinicalTrials.gov NCT01832792 on 9 April 2013 .
-
-###25247433
-BACKGROUND	Although antiretroviral pre-exposure prophylaxis prevents HIV acquisition , it is not known if it alters HIV disease progression .
-BACKGROUND	This study assesses whether tenofovir gel impacted on disease progression among CAPRISA 004 microbicide trial seroconvertors .
-METHODS	Eighty-three seroconvertors from the tenofovir and placebo gel arms of the CAPRISA 004 trial were monitored prospectively for a minimum of 2 years by CD4 count and viral load ( VL ) .
-METHODS	Linear mixed models were fitted to HIV VL , and log rank test was used to compare time to reach CD4 counts of < 350 cells per microliter .
-RESULTS	Median 2-week postinfection VL was 4.74 and 4.45 log copies per milliliter in women assigned to tenofovir gel ( n = 32 ) and placebo gel ( n = 51 ) ( P = 0.189 ) .
-RESULTS	Corresponding 12-month postinfection VLs were 4.24 and 3.70 log copies per milliliter ( P = 0.016 ) .
-RESULTS	After adjusting for clinical and behavioral characteristics and protective HLA alleles , mean VLs within the first 2 years were 4.51 and 4.02 log copies per milliliter in women from the tenofovir and placebo arms ( P = 0.013 ) .
-RESULTS	Among women with vaginal tenofovir measurements , mean VLs were 4.53 and 4.60 log copies per milliliter in those with detectable versus undetectable levels ( P = 0.840 ) .
-RESULTS	Overall mean CD4 counts were 463 and 514 cells per microliter in women assigned to tenofovir and placebo ( P = 0.290 ) .
-RESULTS	Thirty-two women ( 38.6 % ) reached CD4 counts of < 350 cells per microliter at median 9.4 months postinfection , 13 ( 40.6 % ) from the tenofovir and 19 ( 37.3 % ) from the placebo arms ( P = 0.786 ) .
-CONCLUSIONS	Tenofovir gel had no impact on postinfection CD4 counts or the rate of CD4 decline .
-CONCLUSIONS	Although seroconvertors from the tenofovir arm experienced higher VLs , this did not result in a need for earlier antiretroviral therapy .
-
-###24440365
-OBJECTIVE	To determine whether providing a controlled resistance versus assistance to the paretic leg at the ankle during treadmill training will improve walking function in individuals poststroke .
-METHODS	Repeated assessment of the same patients with parallel design and randomized controlled study between 2 groups .
-METHODS	Research units of rehabilitation hospitals .
-METHODS	Patients ( N = 30 ) with chronic stroke .
-METHODS	Subjects were stratified based on self-selected walking speed and were randomly assigned to the resistance or assistance training group .
-METHODS	For the resistance group , a controlled resistance load was applied to the paretic leg at the ankle to resist leg swing during treadmill walking .
-METHODS	For the assistance group , a load that assists swing was applied .
-METHODS	Primary outcome measures were walking speed and 6-minute walking distance .
-METHODS	Secondary measures included clinical assessments of balance , muscle tone , and quality of life .
-METHODS	Outcome measures were evaluated before and after 6 weeks of training and at 8 weeks ' follow-up , and compared within group and between the 2 groups .
-RESULTS	After 6 weeks of robotic training , walking speed significantly increased for both groups , with no significant differences in walking speed gains observed between the 2 groups .
-RESULTS	In addition , 6-minute walking distance and balance significantly improved for the assistance group but not for the resistance group .
-CONCLUSIONS	Applying a controlled resistance or an assistance load to the paretic leg during treadmill training may induce improvements in walking speed in individuals poststroke .
-CONCLUSIONS	Resistance training was not superior to assistance training in improving locomotor function in individuals poststroke .
-
-###24290869
-OBJECTIVE	Newer studies suggest that carvedilol , a beta-blocker with a moderate anti-alpha-1 activity , is superior to propranolol in reducing the portal pressure and risk of variceal bleeding .
-OBJECTIVE	The effect on arterial blood pressure is a matter of concern especially in decompensated patients .
-OBJECTIVE	to assess potential differential effects of beta-blockers and beta-blockers with moderate anti-alpha-1 activity on selected haemodynamic , humoral , and respiratory characteristics in cirrhosis .
-METHODS	Patients with cirrhosis and portal hypertension were randomised to receive carvedilol ( n = 16 ) or propranolol ( n = 13 ) .
-METHODS	Cardiac , systemic and splanchnic parameters along with oxygen saturation and plasma renin were measured at inclusion and after 3 months .
-RESULTS	Arterial blood pressure , heart rate , and cardiac output decreased equally , central circulation time and systemic vascular resistance increased significantly but similarly .
-RESULTS	Central blood volume , plasma volume and arterial compliance were unaltered .
-RESULTS	The QTc interval and renin levels decreased in the carvedilol group , however not significantly different from the propranolol group .
-RESULTS	Arterial oxygen saturation and alveolar arterial oxygen gradient remained constant in both groups .
-RESULTS	Hepatic venous pressure gradient decreased equally in the carvedilol and propranolol groups ( -17 % and -20 % , non significant ) .
-CONCLUSIONS	Systemic haemodynamics and pulmonary effects of carvedilol and propranolol are modest and this study could not demonstrate any significant difference between the two treatments .
-
-###25072757
-OBJECTIVE	To assess the efficacy of a simple , goal-directed sepsis treatment protocol for reducing mortality in patients with severe sepsis in Zambia .
-METHODS	Single-center nonblinded randomized controlled trial .
-METHODS	Emergency department , ICU , and medical wards of the national referral hospital in Lusaka , Zambia .
-METHODS	One hundred twelve patients enrolled within 24 hours of admission with severe sepsis , defined as systemic inflammatory response syndrome with suspected infection and organ dysfunction
-METHODS	: Simplified Severe Sepsis Protocol consisting of up to 4 L of IV fluids within 6 hours , guided by jugular venous pressure assessment , and dopamine and/or blood transfusion in selected patients .
-METHODS	Control group was managed as usual care .
-METHODS	Blood cultures were collected and early antibiotics administered for both arms .
-RESULTS	Primary outcome was in-hospital all-cause mortality .
-RESULTS	One hundred nine patients were included in the final analysis and 88 patients ( 80.7 % ) were HIV positive .
-RESULTS	Pulmonary infections were the most common source of sepsis .
-RESULTS	In-hospital mortality rate was 64.2 % in the intervention group and 60.7 % in the control group ( relative risk , 1.05 ; 95 % CI , 0.79-1 .41 ) .
-RESULTS	Mycobacterium tuberculosis complex was isolated from 31 of 82 HIV-positive patients ( 37.8 % ) with available mycobacterial blood culture results .
-RESULTS	Patients in Simplified Severe Sepsis Protocol received significantly more IV fluids in the first 6 hours ( 2.7 L vs 1.7 L , p = 0.002 ) .
-RESULTS	The study was stopped early because of high mortality rate among patients with hypoxemic respiratory failure in the intervention arm ( 8/8 , 100 % ) compared with the control arm ( 7/10 , 70 % ; relative risk , 1.43 ; 95 % CI , 0.95-2 .14 ) .
-CONCLUSIONS	Factors other than tissue hypoperfusion probably account for much of the end-organ dysfunction in African patients with severe sepsis .
-CONCLUSIONS	Studies of fluid-based interventions should utilize inclusion criteria to accurately capture patients with hypovolemia and tissue hypoperfusion who are most likely to benefit from fluids .
-CONCLUSIONS	Exclusion of patients with severe respiratory distress should be considered when ventilatory support is not readily available .
-
-###24270192
-OBJECTIVE	It is well known that receipt of an initial abnormal cervical cytology test can trigger considerable anxiety among women .
-OBJECTIVE	Less is known about the impact of follow-up by repeat cytology tests .
-OBJECTIVE	We quantified prevalence , and identified predictors , of distress after repeat cytologic testing in women with a single low-grade test .
-METHODS	Within the framework of the TOMBOLA randomized controlled trial of alternative managements , 844 women aged 20 to 59 years with a single routine cytology test showing borderline nuclear abnormalities ( BNA ; broadly equivalent to atypical squamous cells of undetermined significance ) were assigned to follow-up by repeat cytology in primary care ( the first test was due 6 months after the initial BNA result ) .
-METHODS	Women completed sociodemographic and psychosocial questionnaires at recruitment and the Impact of Event Scale ( IES ) 6 weeks after their first follow-up cytology test .
-METHODS	Factors associated with significant psychologic distress ( IES 9 ) were identified using logistic regression .
-RESULTS	The response rate was 74 % ( n = 621/844 ) .
-RESULTS	Of all the respondents , 39 % scored in the range for significant distress .
-RESULTS	Distress varied by follow-up cytology result : negative , 36 % ; BNA or mild dyskaryosis , 42 % ; other ( including high grade and inadequate ) , 55 % .
-RESULTS	After adjusting for the cytology result , risk of distress was significantly raised in women who had significant anxiety at recruitment , reported experiencing pain after the follow-up cytology , had children , or were dissatisfied with support they had received after their initial BNA test .
-CONCLUSIONS	Substantial proportions of women experience surveillance-related psychologic distress after a follow-up cytology test , even when the result is negative .
-CONCLUSIONS	This is an important , albeit unintended , consequence of cervical screening .
-CONCLUSIONS	Strategies to alleviate this distress merit attention .
-
-###24252418
-BACKGROUND	The World Health Organization recommends high-dose vitamin A supplementation ( VAS ) for children above six months of age in low-income countries .
-BACKGROUND	VAS has been associated with up-regulation of the Th2 response .
-BACKGROUND	We aimed to determine if VAS is associated with atopy in childhood .
-METHODS	Infants in Guinea-Bissau were randomly allocated VAS or placebo , either at six and nine months of age , or only at nine months of age .
-METHODS	At six months of age , children were furthermore randomized to measles vaccine or inactivated polio vaccine .
-METHODS	At nine months of age all children received measles vaccine .
-METHODS	Children were revisited seven years later and skin prick testing was performed .
-METHODS	Atopy was defined as a skin prick reaction 3 mm .
-RESULTS	40 of 263 children ( 15 % ) were atopic .
-RESULTS	Overall VAS had no significant effect on the risk of atopy ( Prevalence Ratio 1.23 ; 95 % CI 0.69-2 .18 ) .
-RESULTS	The Prevalence Ratio was 1.60 ( 0.66-3 .90 ) for males and 1.00 ( 0.46-2 .15 ) for females .
-CONCLUSIONS	There was no significant effect of VAS in infancy on atopy later in childhood .
-CONCLUSIONS	The role of infant VAS in the development of atopy is still unclear .
-
-###25006719
-BACKGROUND	Dupilumab , a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13 , has shown efficacy in patients with asthma and elevated eosinophil levels .
-BACKGROUND	The blockade by dupilumab of these key drivers of type 2 helper T-cell ( Th2 ) - mediated inflammation could help in the treatment of related diseases , including atopic dermatitis .
-METHODS	We performed randomized , double-blind , placebo-controlled trials involving adults who had moderate-to-severe atopic dermatitis despite treatment with topical glucocorticoids and calcineurin inhibitors .
-METHODS	Dupilumab was evaluated as monotherapy in two 4-week trials and in one 12-week trial and in combination with topical glucocorticoids in another 4-week study .
-METHODS	End points included the Eczema Area and Severity Index ( EASI ) score , the investigator 's global assessment score , pruritus , safety assessments , serum biomarker levels , and disease transcriptome .
-RESULTS	In the 4-week monotherapy studies , dupilumab resulted in rapid and dose-dependent improvements in clinical indexes , biomarker levels , and the transcriptome .
-RESULTS	The results of the 12-week study of dupilumab monotherapy reproduced and extended the 4-week findings : 85 % of patients in the dupilumab group , as compared with 35 % of those in the placebo group , had a 50 % reduction in the EASI score ( EASI-50 , with higher scores in the EASI indicating greater severity of eczema ) ( P < 0.001 ) ; 40 % of patients in the dupilumab group , as compared with 7 % in the placebo group , had a score of 0 to 1 ( indicating clearing or near-clearing of skin lesions ) on the investigator 's global assessment ( P < 0.001 ) ; and pruritus scores decreased ( indicating a reduction in itch ) by 55.7 % in the dupilumab group versus 15.1 % in the placebo group ( P < 0.001 ) .
-RESULTS	In the combination study , 100 % of the patients in the dupilumab group , as compared with 50 % of those who received topical glucocorticoids with placebo injection , met the criterion for EASI-50 ( P = 0.002 ) , despite the fact that patients who received dupilumab plus glucocorticoids used less than half the amount of topical glucocorticoids used by those who received placebo plus the topical medication ( P = 0.16 ) .
-RESULTS	Adverse events , such as skin infection , occurred more frequently with placebo ; nasopharyngitis and headache were the most frequent adverse events with dupilumab .
-CONCLUSIONS	Patients treated with dupilumab had marked and rapid improvement in all the evaluated measures of atopic dermatitis disease activity .
-CONCLUSIONS	Side-effect profiles were not dose-limiting .
-CONCLUSIONS	( Funded by Regeneron Pharmaceuticals and Sanofi ; ClinicalTrials.gov numbers , NCT01259323 , NCT01385657 , NCT01639040 , and NCT01548404 . )
-
-###26195541
-OBJECTIVE	To determine whether a 2-year family-based intervention using frequent contact and limited expert involvement was effective in reducing excessive weight compared with usual care .
-METHODS	Two hundred and six overweight and obese ( BMI 85th percentile ) children aged 4 to 8 years were randomized to usual care ( UC ) or tailored package ( TP ) sessions at university research rooms .
-METHODS	UC families received personalized feedback and generalized advice regarding healthy lifestyles at baseline and 6 months .
-METHODS	TP families attended a single multidisciplinary session to develop specific goals suitable for each family , then met with a mentor each month for 12 months , and every third month for another 12 months to discuss progress and provide support .
-METHODS	Outcome measurements ( anthropometry , questionnaires , dietary intake , accelerometry ) were obtained at 0 , 12 , and 24 months .
-RESULTS	BMI at 24 months was significantly lower in TP compared with UC children ( difference , 95 % confidence interval : -0.34 , -0.65 to -0.02 ) , as was BMI z score ( -0.12 , -0.20 to -0.04 ) and waist circumference ( -1.5 , -2.5 to -0.5 cm ) .
-RESULTS	TP children consumed more fruit and vegetables ( P = .038 ) and fewer noncore foods ( P = .020 ) than UC children , and fewer noncore foods were available in the home ( P = .002 ) .
-RESULTS	TP children were also more physically active ( P = .035 ) .
-RESULTS	No differences in parental feeding practices , parenting , quality of life , child sleep , or behavior were observed .
-CONCLUSIONS	Frequent , low-dose support was effective for reducing excessive weight in predominantly mild to moderately overweight children over a 2-year period .
-CONCLUSIONS	Such initiatives could feasibly be incorporated into primary care .
-
-###25351474
-BACKGROUND	Inhaled allergen challenge is a standard method to study airway responses to inflammatory provocation and evaluate the therapeutic potential of novel anti-inflammatory compounds in asthma .
-BACKGROUND	MEM 1414 is a novel oral PDE4 inhibitor with high affinity and selectivity creating the potential for an improved side effect profile vs non-selective PDE inhibitors .
-BACKGROUND	We evaluated the tolerability and effect of MEM 1414 on airway responses in mild asthmatics .
-METHODS	A randomised double blind placebo controlled cross over study in two centres , in which sixteen steroid nave atopic asthmatics were challenged with inhaled allergen .
-METHODS	Subjects were dosed with MEM 1414 ( 600mg ) or placebo , twice daily orally for 7days .
-METHODS	Allergen challenge was performed on day 6 ( 2hours post-dose ) , and methacholine responsiveness was measured 24hours post allergen ( day 7 ) .
-METHODS	Biomarkers of drug effects using ex vivo LPS stimulation of whole blood production of interleukin ( IL ) -6 and leukotriene ( LT ) - B4 and fractional exhaled nitric oxide ( FeNO ) were measured on day 6 ( 0 , 2 and 8hours post-dose ) .
-METHODS	Plasma pharmacokinetics were measured on days 1 , 6 and 7 .
-METHODS	The primary endpoint was the effect on late asthmatic response to allergen .
-RESULTS	Treatment with MEM 1414 abrogated the late phase response with a mean difference in FEV1 ( LAR 3-10 hours ) of 104ml ( 25 % ) vs placebo ( p < 0.005 ) , with no effect on the early response .
-RESULTS	Biomarker responses were also attenuated with MEM 1414 treatment with reductions in LPS-stimulated whole blood assays for TNF at 8hours ( p < 0.03 ) and LTB4 at 24hours ( p = 0.0808 ) with no change in the IL-6 response .
-RESULTS	The MEM 1414 treatment phase was associated with higher incidence of nausea ( 6/16 MEM 1414 vs 2/16 placebo ) and vomiting ( 3/16 vs 0/16 placebo ) .
-CONCLUSIONS	Oral MEM 1414 , a novel PDE4 inhibitor , significantly reduces the late response following inhaled allergen challenge .
-CONCLUSIONS	MEM 1414 also inhibited whole blood assays of cytokine production from inflammatory cells .
-CONCLUSIONS	MEM 1414 was associated with a typical adverse event profile of PDE4 inhibitors , namely nausea and vomiting although these were mild side effects .
-BACKGROUND	Current controlled trials ISRCTN48047493 .
-
-###25244801
-OBJECTIVE	Incidence and severity of motion sickness ( MS ) in hot-humid environment are extremely high .
-OBJECTIVE	We tried to know the effect of two-stage training for reducing incidence and severity of ms.
-METHODS	Sixty male subjects were divided into experimental group and control group randomly .
-METHODS	Subjects in experimental group received : ( 2 ) adaptation training including sitting , walking and running in hot lab .
-METHODS	After adaptation confirmation based on subjective feeling , rectal temperature , heart rate , blood Pressure , sweat rates and sweat salt concentration , we tested both groups by Coriolis acceleration revolving chair test and recorded Graybiel 's score and grading of severity to evaluate whether adaptation training was useful ; ( 2 ) Anti-dizzy training 3m later of deacclimatization contained revolving chair training for 10 times .
-METHODS	Then we did the same test as mentioned above to evaluate effect of anti-dizzy training .
-METHODS	RESULST : Graybiel ' s score and grading of severity had no difference between two groups through acclimatization training ( P > 0.05 ) .
-METHODS	While they had difference through anti-dizzy training ( P < 0.01 ) .
-CONCLUSIONS	Adaptation training seems useless for reducing incidence and severity of MS in hot-humid environment , but anti-dizzy training is useful .
-
-###25428755
-OBJECTIVE	Local infiltration analgesia ( LIA ) is well established for effective postoperative pain relief in total knee arthroplasty ( TKA ) .
-OBJECTIVE	To prolong the effect of LIA , infusion pumps with local intraarticular analgesia can be used .
-OBJECTIVE	We evaluated the effect of such an infusion pump for the first 48 h postoperatively regarding pain , knee function , length of stay ( LOS ) in hospital , and complications .
-METHODS	200 patients received peroperative LIA and a continuous intraarticular elastomeric infusion pump set at 2 mL/h .
-METHODS	The patients were randomized either to ropivacaine ( 7.5 mg/mL ) or to NaCl ( 9 mg/mL ) in the pump .
-METHODS	Visual analog scale ( VAS ) pain ( 0-100 mm ) , analgesic consumption , side effects of medicine , range of motion ( ROM ) , leg-raising ability , LOS , and complications during the first 3 months were recorded .
-RESULTS	On the first postoperative day , the ropivacaine group had lower VAS pain ( 33 vs. 40 at 12 noon and 36 vs. 43 at 8 p.m. ; p = 0.02 and 0.03 , respectively ) , but after that all recorded variables were similar between the groups .
-RESULTS	During the first 3 months , the ropivacaine group had a greater number of superficial and deep surgical wound infections ( 11 patients vs. 2 patients , p = 0.02 ) .
-RESULTS	There were no other statistically significant differences between the groups .
-CONCLUSIONS	Continuous intraarticular analgesia ( CIAA ) with ropivacaine after TKA has no relevant clinical effect on VAS pain and does not affect LOS , analgesic consumption , ROM , or leg-raising ability .
-CONCLUSIONS	There may , however , be a higher risk of wound-healing complications including deep infections .
-
-###24401211
-OBJECTIVE	Metabolic syndrome ( MetS ) is associated with adverse cardiovascular events , and impaired vascular function .
-OBJECTIVE	In this study we evaluated the effects of omega-3 polyunsaturated fatty acids ( PUFAs ) supplementation on vascular function , inflammatory and fibrinolytic process in subjects with MetS .
-METHODS	We studied the effect of a 12 weeks oral treatment with 2 g/day of omega-3 PUFAs in 29 ( 15 male ) subjects ( mean age 44 12 years ) with MetS on three occasions ( day0 : baseline , day 28 and day 84 ) .
-METHODS	The study was carried out on two separate arms ( PUFAs and placebo ) , according to a randomized , placebo-controlled , double-blind , cross-over design .
-METHODS	The diagnosis of MetS was based on the guidelines of Adult Treatment Panel III definition .
-METHODS	Endothelial function was evaluated by flow-mediated dilation ( FMD ) of the brachial artery .
-METHODS	Carotid-femoral pulse wave velocity ( PWV ) was measured as an index of aortic stiffness .
-METHODS	Serum levels of interleukin-6 ( IL-6 ) and plasminogen activator inhibitor-1 ( PAI-1 ) were measured by ELISA .
-RESULTS	Treatment with PUFAs resulted in a significant improvement from day 0 to 28 and 84 in FMD and PWV ( p < 0.001 for all ) .
-RESULTS	Nevertheless , treatment with placebo resulted in no significant changes in FMD ( p = 0.63 ) and PWV ( p = 0.17 ) .
-RESULTS	Moreover , PUFAs treatment , compared to placebo , decreased IL-6 levels ( p = 0.03 ) and increased PAI-1 levels ( p = 0.03 ) .
-RESULTS	Finally , treatment with PUFAs resulted in a significant decrease in fasting triglyceride levels from day 0 to 28 and 84 ( p < 0.001 ) and in serum total cholesterol levels ( p < 0.001 ) .
-CONCLUSIONS	In subjects with MetS , treatment with omega-3 PUFAs improved endothelial function and arterial stiffness with a parallel antiinflammatory effect .
-
-###25005650
-OBJECTIVE	The optimal management of treatment for patients at intermediate risk of a common duct stone ( including increased liver function tests but bilirubin < 4 mg/dL and no cholangitis ) is a matter of debate .
-OBJECTIVE	Many stones migrate spontaneously into the duodenum , making preoperative common duct investigations unnecessary .
-OBJECTIVE	To compare strategies of cholecystectomy first vs a sequential endoscopic common duct assessment and cholecystectomy for the management of patients with an intermediate risk of a common duct stone .
-OBJECTIVE	The main objective was to reduce the length of stay and the secondary objectives were to reduce the number of common duct investigations , morbidity , and costs .
-METHODS	Interventional , randomized clinical trial with 2 parallel groups performed between June 2011 and February 2013 , with a patient follow-up of 6 months .
-METHODS	The trial comprised a random sample of 100 adult patients admitted to Geneva University Hospital , Geneva , Switzerland , for acute gallstone-related conditions with an intermediate risk of a common duct stone .
-METHODS	Fifty patients were randomized to each group .
-METHODS	Cholecystectomy first with intraoperative cholangiogram for the study group and endoscopic common duct assessment and clearance followed by cholecystectomy for the control group .
-METHODS	Length of initial hospital stay ( primary end point ) , number of common duct investigations and morbidity and mortality within 6 months after initial admission , and quality of life at 1 and 6 months after discharge ( EQ-5D-5L [ EuroQol Group , 5-level ] questionnaire ) .
-RESULTS	Patients who underwent cholecystectomy as a first step had a significantly shorter length of hospital stay ( median , 5 days [ interquartile range { IQR } , 1-8 ] vs median , 8 days [ IQR , 6-12 ] ; P < .001 ) , with fewer common duct investigations ( 25 vs 71 ; P < .001 ) , no significant difference in morbidity or quality of life .
-CONCLUSIONS	Among patients at intermediate risk of a common duct stone , initial cholecystectomy compared with sequential common duct endoscopy assessment and subsequent surgery resulted in a shorter length of stay without increased morbidity .
-CONCLUSIONS	If these findings are confirmed , initial cholecystectomy with intraoperative cholangiogram may be a preferred approach .
-BACKGROUND	Clinicaltrials.gov Identifier : NCT01492790 .
-
-###24846622
-OBJECTIVE	To compare the safety of a single-piece , foldable intraocular lens ( IOL ) hydroimplantation with that of a standard implantation using an ophthalmic viscosurgical device ( OVD ) .
-METHODS	One hundred consecutive patients with bilateral age-related cataract surgery were enrolled into a prospective double-blind study .
-METHODS	Each patient 's first eye was randomly assigned to a standard implantation technique with an OVD or the hydroimplantation technique , while the fellow eye received the opposite technique .
-METHODS	The main outcomes measured were endothelial cell loss , postoperative changes of intraocular pressure ( IOP ) , and the frequency of complications .
-RESULTS	The reduction of endothelial cell density 1 month and 6 months after the surgery was 9.76 % 13.5 % , 10.7 % 12.6 % , respectively , in group A ( OVD ) and 9.07 % 12.7 % , 9.13 % 13.7 % , respectively , in group B ( hydroimplantation ) .
-RESULTS	The differences were not statistically significant .
-RESULTS	The mean IOP 2 hours after surgery was 10.19 6.78 mm Hg in group A and 9.92 7.01 mm Hg in group B. Twenty-four hours and 1 month after surgery , the mean IOP was 14.52 5.59 mm Hg and 13.21 3.5 mm Hg , respectively , in group A , and 15.45 5.77 mm Hg and 13.1 3.44 mm Hg , respectively , in group B.
-RESULTS	The differences between groups A and B were not statistically significant .
-CONCLUSIONS	The hydroimplantation technique is a safe technique for single-piece foldable IOL implantation .
-CONCLUSIONS	There was no increase in intraoperative and postoperative complications compared with the standard implantation technique using an OVD .
-
-###25573751
-OBJECTIVE	This study aimed to investigate how the organic cation transporter 2 nucleotide polymorphism at site 808 ( G T ) affects metformin pharmacokinetics and its long-term anti-diabetic effect .
-METHODS	A total of 220 newly diagnosed type 2 diabetes patients taking oral metformin were recruited , genotyped and then divided into three groups by SLC22A2 genotypes ( G/G , G/T , T/T ) .
-METHODS	Nine patients in the GG genotype group , five patients in the GT genotype group and four patients in the TT genotype group were randomly selected for the metformin pharmacokinetic study .
-METHODS	A randomized cohort study with 1-year follow-up was performed to clarify the metformin pharmacodynamics .
-RESULTS	After 1 year , the decrease in glycosylated hemoglobin ( HbA1c ) levels in subjects with the heterozygous variant genotype ( GT ) was significantly greater than in those with the wild-type homozygote ( -2.2 % in GT vs. -1.1 % in GG , P < 0.05 ) after adjustment for baseline HbA1c levels , exercise and diet in each group .
-RESULTS	There were also differences in the pharmacokinetic parameters ( 95 % confidence interval ) of metformin between these two groups [ area under the concentration-time curve ( AUC ) 0 - 19.7 ( 15.7-23 .8 ) vs. 14.3 ( 11.7-16 .9 ) g h/L ; renal clearance ( CLr ) 16.8 ( 8.5-25 .0 ) vs. 34.1 ( 24.9-43 .2 ) L/h ; tubular secretion clearance ( CLt ) 8.1 ( 2.2-18 .1 ) vs. 22.7 ( 15.5-29 .8 ) L/h ; all P < 0.05 ] .
-RESULTS	Multivariate analysis further revealed that the presence of T alleles and gender were independent influencing factors of urine excretion of metformin ( P < 0.05 ) .
-CONCLUSIONS	As well as gender , the glucose-lowering efficiency of metformin can be enhanced by SLC22A2 808G > T variants through the delay of its transportation and CLr in Chinese type 2 diabetes populations .
-
-###25261789
-BACKGROUND	Electronic cigarettes ( e-cigarettes ) have been reported to reduce tobacco craving and withdrawal ; however , the mechanisms underlying these effects have not been elucidated .
-METHODS	This study examined the contributions of nicotine stimulus and response expectancies to responses to nicotine-free e-cigarettes in 21 e-cigarette nave smokers ( 12 male ) .
-METHODS	Participants completed two randomized experimental sessions in which they administered a nicotine-free e-cigarette .
-METHODS	During one session they were informed that the e-cigarette contained nicotine and during the other session they were informed that the e-cigarette was nicotine-free .
-METHODS	Participants completed subjective assessments before and immediately after sampling ten puffs from the e-cigarette and were then invited to earn additional puffs using a computerized progressive ratio task .
-METHODS	Prior to their enrolment in the study , participants provided an estimate of the relative importance of the nicotine content of e-cigarettes for craving relief .
-RESULTS	Instructions that the e-cigarette contained nicotine were found to reduce both intention to smoke ( p = 0.017 ) and withdrawal-related ( p = 0.018 ) craving , regardless of a-priori reported beliefs regarding the relative importance of nicotine .
-RESULTS	Nicotine content instructions were also found to be associated with a shorter latency to self-administration ( p = 0.005 ) ; however , a SexInstructionsResponse Expectancy interaction ( p = 0.008 ) revealed that this effect was specific to women who had strong a-priori nicotine content craving relief expectations .
-RESULTS	Neither nicotine content instructions nor response expectancies impacted the number of puffs self-administered .
-CONCLUSIONS	Findings suggest that nicotine content expectations contribute to smokers ' responses to e-cigarettes , and that a-priori beliefs about nicotine effects may be especially important in women .
-
-###24473908
-OBJECTIVE	Gastric intestinal metaplasia ( GIM ) is associated with a risk for development of intestinal-type gastric cancer .
-OBJECTIVE	This study aimed to compare the diagnostic yield of GIM from confocal laser endomicroscopy ( CLE ) and white light endoscopy ( WLE ) .
-METHODS	In a prospective , double-blind , randomized study , patients were randomly assigned to receive either CLE with targeted biopsies ( group A ) or WLE with a standard biopsy protocol ( group B ) .
-RESULTS	A total of 168 patients were finally analyzed ( group A 85 , group B 83 ) .
-RESULTS	On a per-patient analysis , the diagnostic yields of GIM ( including GIM with gastric intraepithelial neoplasia [ GIN ] ) for groups A and B were 44.71 % and 31.33 % , respectively ( P = 0.074 ) .
-RESULTS	On a per-biopsy analysis , CLE-targeted biopsy gave a significantly higher diagnostic yield of GIM compared with WLE and standard biopsy , at 65.70 % ( 113/172 biopsies ) versus 15.73 % ( 81/515 biopsies ) ( P < 0.001 ) .
-RESULTS	Moreover , the diagnostic yield of the operative link on gastric intestinal metaplasia ( OLGIM ) assessment stages III and IV was higher at 20.93 % ( 36/172 biopsies ) in group A versus 4.08 % ( 21/515 biopsies ) in group B ( P < 0.001 ) .
-RESULTS	In addition , use of CLE-guided biopsy significantly decreased by 68 % ( P < 0.001 ) the mean number of biopsies required per patient .
-CONCLUSIONS	CLE with targeted biopsies is superior to WLE with standard biopsies for the detection and surveillance of GIM .
-CONCLUSIONS	The number of biopsies needed to confirm GIM is about one third of that needed with WLE with standard biopsies .
-
-###25415159
-OBJECTIVE	To assess whether outpatient cervical ripening at 41 0/7 weeks of gestation with the nitric oxide donor isosorbide mononitrate reduces cesarean delivery rates in nulliparous women with an unfavorable cervix .
-METHODS	We recruited nulliparous pregnant women with a Bishop score less than 6 in a randomized , multicenter , double-blind , placebo-controlled trial .
-METHODS	Women received 40 mg vaginal isosorbide mononitrate or a placebo at 41 0/7 , 41 2/7 , and 41 4/7 weeks of gestation .
-METHODS	They returned home between visits .
-METHODS	At 41 5/7 weeks of gestation , for women who had not yet given birth , labor was induced with oxytocin or prostaglandins , depending on cervical status .
-METHODS	We needed 685 women per group to detect a 25 % reduction in the cesarean delivery rate , the primary outcome measure , from 25 % in the placebo group to 18.75 % in the isosorbide mononitrate group ( 1 - = 0.8 , = 0.05 , two-sided ) .
-RESULTS	The NOCETER ( NO donors for reduction of CEsareans at TERm ) trial was a negative study .
-RESULTS	The cesarean delivery rate was 27.3 % ( 185/678 ) in the isosorbide mononitrate group and 27.2 % ( 186/684 ) in the placebo group ( relative risk 1.00 , 95 % confidence interval [ CI ] 0.84-1 .19 ) .
-RESULTS	None of the maternal secondary efficacy outcomes differed between groups .
-RESULTS	Side effects were more common among women receiving isosorbide mononitrate than in the placebo group ( 78.8 % [ 534/678 ] compared with 27.9 % [ 191/684 ] , relative risk 2.82 , 95 % CI 2.49-3 .20 ) .
-RESULTS	Composite perinatal morbidity did not differ between groups .
-CONCLUSIONS	Outpatient cervical ripening with vaginal isosorbide mononitrate for prolonged pregnancy in nulliparous women does not reduce cesarean delivery rate .
-BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT00930618 .
-
-###24372304
-OBJECTIVE	Activated Protein C ( APC ) stimulates multiple cytoprotective pathways via the protease activated receptor-1 ( PAR-1 ) and promotes anticoagulation .
-OBJECTIVE	3K3A-APC was designed for preserved activity at PAR-1 with reduced anticoagulation .
-OBJECTIVE	This Phase 1 trial characterized pharmacokinetics and anticoagulation effects of 3K3A-APC .
-METHODS	Subjects ( n = 64 ) were randomly assigned to receive 3K3A-APC ( n = 4 ) at 6 , 30 , 90 , 180 , 360 , 540 or 720 g/kg or placebo ( n = 6 ) and were observed for 24 hr .
-METHODS	After safety review additional subjects received drug every 12 hr for 5 doses ( n = 6 per group ) at 90 , 180 , 360 , or 540 g/kg or placebo ( n = 8 ) and were observed for 24 hr .
-RESULTS	All subjects returned for safety assessments at 72 hours and 15 days .
-RESULTS	We found few adverse events in all groups .
-RESULTS	Systolic blood pressure increased in both active and placebo groups .
-RESULTS	Moderately severe headache , nausea and vomiting were reported in one of two subjects treated with 720 g/kg so 540 g/kg was considered the highest tolerated dose .
-RESULTS	Mean plasma concentrations increased in proportion to dose .
-RESULTS	Clearance ranged from 11,693 807 to 18,701 4,797 mL/hr , volume of distribution ranged from 4,873828 to 6,971 1,169 mL , and elimination half-life ranged from 0.211 0.097 to 0.294 0.054 hours .
-RESULTS	Elevations in aPTT were minimal .
-CONCLUSIONS	3K3A-APC was well tolerated at multiple doses as high as 540 g/kg .
-CONCLUSIONS	These results should be confirmed in stroke patients with relevant co-morbidities .
-CONCLUSIONS	Clinical Trial Registration-URL : http://www.clinicaltrials.gov .
-CONCLUSIONS	Unique identifier : NCT01660230 .
-
-###25103657
-OBJECTIVE	To evaluate the effect of warm ophthalmic viscosurgical devices ( OVDs ) on the unfolding time of prehydrated hydrophobic acrylic intraocular lenses ( IOLs ) .
-METHODS	Experimental study and human trial .
-METHODS	Three foldable hydrophobic acrylic IOLs ( enVista MX60 , AcrySof SN60AT , and Tecnis 1 ZCB00 ) .
-METHODS	The unfolding times of 3 kinds of IOLs were measured according to temperature from 26C to 32C in a transparent container filled with a mixture of OVDs and balanced salt solution .
-METHODS	The unfolding time of each IOL was measured 4 times for each temperature .
-METHODS	Unfolding time was defined as the time required for the folded IOL to recover 90 % of its overall optic diameter before folding .
-METHODS	In human trials , the unfolding time of the MX60 in a capsular bag filled with 30C OVDs was compared with that filled with room temperature OVDs for 4 cases in each group .
-RESULTS	The unfolding time of the MX60 ( 215 25 seconds ) was significantly longer than that of the SN60AT ( 28 7 seconds ) and the ZCB00 ( 29 7 seconds ) at 26C ( p = 0.013 ) .
-RESULTS	However , there were no differences in the unfolding time of 3 IOLs at 32C .
-RESULTS	In human trials , the unfolding time of the MX60 was shorter in a capsular bag filled with 30C OVDs ( 32 13 seconds ) than if filled with OVDs kept at room temperature ( 127 27 seconds ; p = 0.029 ) .
-CONCLUSIONS	When fast and complete unfolding characteristics are needed , filling the anterior chamber and capsular bag with OVDs warmed to 30C before IOL implantation is recommended .
-
-###25873067
-BACKGROUND	Panic disorder with or without agoraphobia is a commonly occurring disorder affecting 2 to 3 % of the population in Sweden .
-BACKGROUND	Untreated , panic disorder is a chronic condition that significantly increases the risk for psychiatric comorbidity , morbidity and mortality , employment difficulties , and healthcare utilization .
-BACKGROUND	Cognitive behavioral approaches are the recommended first-line treatment for panic disorder ; however , many patients in routine care receive another evidence-based psychotherapy , including psychodynamic therapy .
-BACKGROUND	Allowing patients to choose among evidence-based approaches to panic disorder may improve outcomes and reduce overall health costs .
-BACKGROUND	Trials comparing the ` gold standard ' treatment for panic disorder to other evidence-based psychotherapies are needed , and also trials that can separate patient preferences for treatment from randomization effects on outcome , disability and healthcare utilization in the longer term .
-METHODS	A phase 2/3 doubly-randomized controlled trial carried out in routine care with 216 adults ( aged 18 to 70 years ) with a primary diagnosis of DSM-IV Panic Disorder ( with or without Agoraphobia ) .
-METHODS	Within each clinic , patients are randomized to self-selection , random assignment of treatment , or wait-list .
-METHODS	Patients choose or are randomly assigned to either Panic Control Treatment or Panic-Focused Psychodynamic Psychotherapy .
-METHODS	Primary outcomes are changes in panic symptom severity , occupational status , and sickness-related absences from work at post-treatment and 6 , 12 and 24 months post-treatment .
-METHODS	Secondary outcomes include changes in agoraphobic avoidance , psychiatric comorbidity , disability , and healthcare utilization .
-METHODS	The study also employs elements of an effectiveness trial as therapist and service-related effects on outcome will be estimated .
-METHODS	Putative change mechanisms for the two treatments are also assessed .
-CONCLUSIONS	Cognitive behavioral and psychodynamic therapies are both evidence-based approaches that are routinely offered to panic disordered patients in Sweden .
-CONCLUSIONS	However , little is known about the relative effectiveness of these two approaches for panic/agoraphobia , work-related disability and healthcare utilization over the longer term .
-CONCLUSIONS	The current trial ( POSE ) also addresses the important but understudied issue of whether patient preference for a particular psychotherapeutic approach moderates outcome .
-BACKGROUND	ClinicalTrials.gov NCT01606592 ( registered 19 March 2012 ) .
-
-###25794203
-BACKGROUND	The sympathetic nervous system plays an important role in the arousal response .
-BACKGROUND	Recently , the stellate ganglion block ( SGB ) was found to effectively treat anxiety and night awakening in humans and decrease electroencephalogram ( EEG ) indices of arousal responses in rat .
-BACKGROUND	But , the role of the sympathetic block in human arousal responses has not yet been studied .
-OBJECTIVE	We performed this prospective , double-blinded , controlled volunteer study to investigate the sedative effects and bispectral index ( BIS ) changes of SGB .
-METHODS	A randomized , double-blind trial .
-METHODS	Single academic medical center .
-METHODS	This study was approved by the Ethics Committee of Kyungpook National University Hospital ( ref : KNUH-10-1081 ) and registered with CRiS ( Clinical Research Information Service , http://cris.cdc.go.kr , ref : KCT0000036 , 2010.9.24 ) .
-METHODS	Twenty healthy volunteers were enrolled in this study .
-METHODS	The volunteers were randomly assigned to one of 2 groups : the SGB group ( n = 10 ) and the sham group ( n = 10 ) .
-METHODS	Volunteers in SGB group received SGB and volunteers in the sham group received a sham procedure .
-METHODS	BIS value , heart rate , and blood pressure were measured before and 5 , 10 , 20 , and 30 minutes after the procedure .
-METHODS	Observer 's Assessment of Alertness/Sedation ( OAA/S ) scores were assessed before and 10 and 30 minutes after the intervention .
-RESULTS	In the SGB group , BIS values and OAA/S scores significantly decreased after the intervention as compared to baseline ( P < 0.05 ) .
-RESULTS	The values were also significantly decreased in the SGB group when compared to the values in sham group after the intervention ( P < 0.05 ) .
-RESULTS	There was a significant change of mean blood pressure 10 to 30 minutes after SGB ( P < 0.05 ) .
-RESULTS	There were no differences in heart rate during study period between groups .
-CONCLUSIONS	This study is limited by a relatively small sample size .
-CONCLUSIONS	This study showed that SGB has a sedative effect in normal healthy volunteers , as evidenced by decreased OAA/S scores and BIS values .
-
-###24372182
-BACKGROUND	Despite the reported widespread use of herbal medicines globally and their benefits , they are not completely without potential to cause harm .
-BACKGROUND	The haphazard , irresponsible or non-regulated use of several herbal medicines may put the health of their users at risk of toxicity .
-OBJECTIVE	This study aimed to assess the general perception of the safety and occurrence of adverse effects of herbal medicines among residents of Ikorodu in Lagos , Nigeria .
-METHODS	The study population included 400 randomly selected and consented residents in Ikorodu .
-METHODS	Data was collected using a standard closed and open-ended structured questionnaire with three ( 3 ) sections on socio-demography , safety and adverse effects of herbal medicines .
-METHODS	Associations between the variables were determined using Chi square analysis .
-RESULTS	The results showed that 333 respondents ( 82.4 % ) believed that herbal medicines are safe for use and only 39 ( 9.7 % ) held the view that they may not be safe .
-RESULTS	RESULTS also show that 51 ( 12.6 % ) of respondents had experienced adverse effects while 250 ( 61.9 % ) said they had never experienced adverse effects from the use of herbal medicines .
-CONCLUSIONS	Herbal medicine is popular among the respondents but they appear to be ignorant of its potential toxicities .
-CONCLUSIONS	It may be necessary to educate the consumers of herbal medicines on the potentials for herbs-drugs interaction and adverse effects specially as a result of indiscriminate and unguided use of herbal medicines .
-
-###24576082
-OBJECTIVE	To identify risk factors for early hospital readmission in low-income community-dwelling older adults .
-METHODS	Prospective cohort study .
-METHODS	University-affiliated urban safety-net healthcare system in Indianapolis , Indiana .
-METHODS	Community-dwelling adults aged 65 and older with annual income less than 200 % of the federal poverty level and enrolled in the Geriatric Resources for Assessment and Care of Elders ( GRACE ) randomized controlled trial ( N = 951 ) .
-METHODS	Participant health and functional status at baseline and 6 , 12 , 18 , and 24 months .
-METHODS	Early readmission was defined as a repeat hospitalization occurring within 30 days of a prior hospital discharge .
-METHODS	Candidate risk factors included sociodemographic characteristics , health and functional status , prior care , lifestyle , and satisfaction with care .
-RESULTS	Of 457 index admissions in 328 participants , 85 ( 19 % ) were followed by an early readmission .
-RESULTS	The independent risk factors for early readmission identified according to regression analysis were living alone ( odds ratio ( OR ) = 1.71 , 95 % confidence interval ( CI ) = 1.02-2 .87 ) , fair or poor satisfaction with primary care physician ( OR = 2.12 , 95 % CI = 1.01-4 .46 ) , not having Medicaid ( OR = 1.80 , 95 % CI = 1.05-3 .11 ) , receiving a new assistive device in the past 6 months ( OR = 2.26 , 95 % CI = 1.26-4 .05 ) , and staying in a nursing home in the past 6 months ( OR = 5.08 , 95 % CI = 1.56-16 .53 ) .
-RESULTS	Age , race , sex , education , and chronic diseases were not associated with early readmission .
-CONCLUSIONS	A broad range of nonmedical risk factors played a greater role than previously recognized in early hospital readmission of low-income seniors .
-
-###25825944
-BACKGROUND	Gonadotropin therapy using a human chorionic gonadotropin ( hCG ) and FSH preparation is an effective regimen in inducing masculinization and spermatogenesis in men with idiopathic hypogonadotropic hypogonadism ( IHH ) .
-BACKGROUND	However , the high cost of medication and frequent injections affect compliance .
-OBJECTIVE	The aim of this study was to determine the efficacy of sequential use of highly purified urinary FSH ( uFSH ) / hCG in men with IHH .
-METHODS	A randomized , open-label , prospective , controlled noninferiority trial with an 18-month follow-up was conducted in 9 tertiary hospitals .
-METHODS	A total of 67 Chinese men with IHH were randomly allocated into group A receiving continual uFSH ( 75 U , 3 times a week ) and hCG ( 2000 U , twice a week ) injection and group B receiving sequential uFSH ( 75 U , 3 times a week every other 3 months ) and hCG ( 2000 U , twice a week ) injection .
-METHODS	The primary outcome was the proportion of subjects with a sperm concentration of 1.0 10 ( 6 ) / mL during the 18 months .
-METHODS	The efficacy between groups A and B was compared for noninferiority .
-RESULTS	Of the patients , 17/33 ( 51.5 % ) receiving continual uFSH/hCG and 19/34 ( 55.9 % ) receiving sequential uFSH/hCG achieved sperm concentrations of 1.0 10 ( 6 ) / mL .
-RESULTS	The efficacy in the sequential uFSH/hCG group was not inferior to that in the continual uFSH/hCG group ( noninferiority , P = .008 ) by intention-to-treat analysis .
-CONCLUSIONS	The efficacy of the sequential uFSH/hCG regimen is not inferior to that of the continual uFSH/hCG regimen in inducing spermatogenesis and masculinization of patients with IHH .
-
-###24374800
-OBJECTIVE	There was no standard treatment for hepatocellular carcinoma with portal vein tumour thrombosis ( PVTT ) .
-OBJECTIVE	This prospective , randomised , two-arm clinical trial aims to investigate the feasibility , safety and effectiveness of transarterial chemoembolisation ( TACE ) combined with the endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus conventional TACE .
-METHODS	Eighty-five patients who met the eligibility requirements were randomly assigned to receive the treatment of TACE combined with the endovascular implantation of an iodine-125 seed strand ( 43 cases ) or conventional TACE ( 42 cases ) .
-METHODS	The end points were survival time , complications related to the procedure and adverse events .
-RESULTS	No significant differences in baseline characteristics were observed between groups .
-RESULTS	The mean and median survival times were 221.7 16.3 days [ 95 % confidence interval ( CI ) 189.8-253 .6 days ] and 210.0 17.5 days ( 95 % CI 175.8-244 .2 days ) in group A and 155.1 7.9 days ( 95 % CI 139.6-170 .5 days ) and 154.0 11.2 days ( 95 % CI 133.2-176 .0 days ) in group B ( P = 0.000 ) .
-RESULTS	The 90 - , 180 - and 360-day cumulative survival rates were 97.6 , 58.9 and 12.3 % in group A and 92.5 , 30.7 and 0 % in group B ( P = 0.000 ) .
-CONCLUSIONS	Transarterial chemoembolisation combined with the endovascular implantation of an iodine-125 seed strand is feasible , safe and effective in the treatment for hepatocellular carcinoma with PVTT .
-
-###24977247
-OBJECTIVE	To compare the effectiveness of two different techniques to lift the maxillary sinus via a crestal approach : the Summers versus the Cosci technique .
-METHODS	Fifteen partially edentulous patients missing bilaterally maxillary molars and / or premolars , having 4 to 7 mm of residual crestal height and at least 5 mm thickness below the maxillary sinuses measured on CT scans , were randomised to have implants placed in sinuses crestally lifted according to the Cosci or the Summers techniques , with bone substitutes according to a split-mouth design .
-METHODS	Implants were left to heal submerged for 6 months .
-METHODS	Implants were loaded with acrylic provisional crowns/prostheses .
-METHODS	Screw-retained definitive metal-ceramic prostheses were delivered 4 months after provisional loading .
-METHODS	Outcome measures were : prosthesis and implant failures ; any complications ; operation time ; operator preference ; patient preference and peri-implant marginal bone level changes assessed by a blinded outcome assessor .
-METHODS	All patients were followed to 3 years after implant loading .
-RESULTS	Nineteen study implants were placed according to each technique .
-RESULTS	Three years after loading , 3 patients dropped out and no implant failed .
-RESULTS	No discomfort/complications occurred at sites treated with the Cosci technique , whereas 12 patients reported discomfort during the augmentation procedure at the side treated with the Summers technique ; this was statistically significant ( P = 0.0005 ) .
-RESULTS	In one of these patients , a perforation of the sinus membrane occurred .
-RESULTS	Postoperatively , headache was reported by 9 patients and swelling occurred in 3 of these patients at the Summers treated sides .
-RESULTS	Statistically significant less time ( 9.7 mins , SD = 4.0 , P < 0.001 , 95 % CI -11.9 to -7.5 ) was required to place implants according to the Cosci technique ( 33 versus 24 mins on average ) .
-RESULTS	The 2 operators and 14 out of 15 patients preferred the Cosci technique 1 month after surgery ( P = 0.001 ) , and 1 year after surgery ( 13 out of 15 patients , P = 0.007 ) .
-RESULTS	The ceramic layer of one prosthesis of the Summers ' group and one abutment screw of the Cosci 's group loosened between 1 to 3 years post-loading .
-RESULTS	After 3 years , implants inserted according to the Cosci technique lost 1.39 mm of peri-implant bone versus 1.54 mm for the implants placed with the Summers technique .
-RESULTS	There were no statistically significant differences for marginal bone level changes between the two groups ( difference 0.15 mm , 95 % CI -0.11 to 0.41 , P = 0.24 ) .
-CONCLUSIONS	Both crestal sinus lift techniques produced successful results over a 3-year follow-up period , but the Cosci technique required less surgical time , determined less intra - and postoperative morbidity and was preferred by patients .
-CONCLUSIONS	Conflict of interest statement : This was an investigator-initiated trial , however the trial was partially supported by Zimmer Dental Italy , Vittorio Veneto ( TV ) , Italy .
-CONCLUSIONS	One of the authors ( Dr Cosci ) , who treated 8 patients in this study , is the inventor of the Cosci technique and his partipation was a prerequisite of the sponsor to support the trial .
-
-###24672935
-OBJECTIVE	To study the effect of blood activating water relieving method ( BAWRM ) on heart functions and serum levels of NT-proBNP in patients with heart failure with normal ejection fraction ( HFNEF ) .
-METHODS	Sixty-four HFNEF patients were admitted to our hospital during January 2011 to June 2012 .
-METHODS	They were randomly assigned to the treatment group ( 32 cases ) and the control group ( 32 cases ) .
-METHODS	Patients in the control group received routine Western medical treatment , while those in the treatment group additionally took Chinese medical recipes for activating blood circulation and relieving water retention .
-METHODS	Changes of Chinese medical syndromes , E/E ' , serum NT-proBNP contents were observed between the two groups .
-RESULTS	Compared with before treatment , their Chinese medical syndromes and E/E ' were significantly improved , and serum NT-proBNP contents decreased in the two groups ( P < 0.05 ) .
-RESULTS	Compared with the control group , Chinese medical syndromes , E/E ' , serum NT-proBNP contents obviously decreased in the treatment group , showing statistical difference ( P < 0.05 ) .
-CONCLUSIONS	BAWRM was an effective way to improve the diastolic function of HFNEF patients and lower the serum level of NT-proBNP with confirmative efficacy .
-
-###25024243
-OBJECTIVE	This study aimed to implement a point-of-care cluster randomized trial using electronic health records .
-OBJECTIVE	We evaluated the effectiveness of electronically delivered decision support tools at reducing antibiotic prescribing for respiratory tract infections in primary care .
-METHODS	Family practices from England and Scotland participating in the Clinical Practice Research Datalink ( CPRD ) were included in the trial ; 53 family practices were allocated to intervention and 51 practices were allocated to usual care .
-METHODS	Patients aged 18 to 59 years consulting for respiratory tract infections were eligible .
-METHODS	The intervention was through remotely installed , computer-delivered decision support tools accessed during the consultations .
-METHODS	Control practices provided usual care .
-METHODS	The primary outcome was the proportion of consultations for respiratory tract infections with an antibiotic prescribed based on electronic health records .
-METHODS	Family practice-specific proportions were included in a cluster-level analysis .
-RESULTS	Data were analyzed for 603,409 patients : 317,717 at intervention practices and 285,692 at control practices .
-RESULTS	Use of the intervention was less than anticipated , varying among practices .
-RESULTS	There was a reduction in proportion of consultations with antibiotics prescribed of 1.85 % ( 95 % CI , 0.10 % -3.59 % , P = .038 ) and in the rate of antibiotic prescribing for respiratory tract infections ( 9.69 % ; 95 % CI , 0.75 % -18.63 % , fewer prescriptions per 1,000 patient-years , P = .034 ) .
-RESULTS	There were no adverse events .
-CONCLUSIONS	Cluster randomized trials may be implemented efficiently in large samples from routine care settings by using primary care electronic health records .
-CONCLUSIONS	Future studies should develop and test multicomponent methods for remotely delivered intervention .
-
-###25909208
-OBJECTIVE	to compare the biological efficacy of generic enoxaparin ( HeptronTM ) versus branded Sanofi-Aventis enoxaparin for prophylaxis and treatment of lower-extremity deep venous thrombosis ( DVT ) in a prospective , randomized , open-label study .
-METHODS	patients with diagnosed lower-extremity DVT ( therapeutic branch , n = 57 ) and patients requiring venous thromboembolism ( VTE ) prophylaxis after arterial vascular surgery or major lower-extremity amputations ( prophylactic branch , n = 57 ) were randomized to receive generic or branded enoxaparin for up to seven days .
-METHODS	Enoxaparin activity was measured by estimating blood anti-factor Xa levels at the peak plasma concentration .
-METHODS	As secondary outcomes , development or progression of VTE events , major adverse events and major bleeding events were considered for efficacy and safety comparisons .
-RESULTS	DVT therapy : twenty-five patients received generic enoxaparin while 32 received branded enoxaparin ( subcutaneous , 1 mg/kg BID ) .
-RESULTS	Mean percentages of anti-factor Xa levels within the target ranges were 62 35.4 % and 67.5 24.7 % , respectively ( p = .035 for non-inferiority ) .
-RESULTS	No patient presented DVT progression , clinically detectable pulmonary embolism , or major bleeding events in any subgroup .
-RESULTS	DVT prophylaxis : Thirty patients received generic enoxaparin and 27 received branded enoxaparin ( subcutaneous , 40 mg/day ) .
-RESULTS	Mean percentages of anti-factor Xa levels within the target ranges were 77.9 30.9 % and 77.8 32.9 % , respectively ( p = .009 for non-inferiority ) .
-RESULTS	There were no cases of VTE or major bleeding events in any subgroup .
-CONCLUSIONS	generic and branded enoxaparins exhibited similar in vivo responses as measured by the anti-factor Xa activity , as well as similar clinical efficacy and safety outcomes .
-
-###25104273
-OBJECTIVE	Kidney function gradually decreases with age , and myocardial infarction accelerates this deterioration .
-OBJECTIVE	Omega-3 ( n-3 ) fatty acids may slow down the decline of kidney function .
-OBJECTIVE	The effect of marine and plant-derived n-3 fatty acids on kidney function in patients after myocardial infarction was examined .
-METHODS	In the Alpha Omega Trial , 2344 patients with history of myocardial infarction ages 60-80 years old ( 81 % men ) were randomized to one of four trial margarines .
-METHODS	The patients received an additional targeted amount of 400 mg/d eicosapentaenoic acid and docosahexaenoic acid , 2 g/d - linolenic acid , eicosapentaenoic acid-docosahexaenoic acid plus - linolenic acid , or placebo for 40 months .
-METHODS	Serum cystatin C and serum creatinine were assessed at baseline and after 40 months .
-METHODS	Creatinine-cystatin C-based GFR was estimated with the Chronic Kidney Disease Epidemiology Collaboration equation .
-RESULTS	Patients consumed 19.9 g margarine/d , providing an additional 239 mg/d eicosapentaenoic acid with 159 mg/d docosahexaenoic acid , 1.99 g/d - linolenic acid , or both in the active treatment groups .
-RESULTS	After 40 months , compared with baseline , mean ( SD ) creatinine-cystatin C-based GFR was -6.9 ( 12.6 ) , -4.8 ( 13.4 ) , -6.2 ( 12.8 ) , and -6.0 ( 13.0 ) ml/min per 1.73 m ( 2 ) in the placebo , eicosapentaenoic acid-docosahexaenoic acid , - linolenic acid , and eicosapentaenoic acid-docosahexaenoic acid plus - linolenic acid groups , respectively .
-RESULTS	After 40 months , in patients receiving eicosapentaenoic acid-docosahexaenoic acid compared with placebo , the decline in creatinine-cystatin C-based GFR was 2.1 less ( 95 % confidence interval , 0.6 to 3.6 ; P < 0.01 ) ml/min per 1.73 m ( 2 ) ; other comparisons were not statistical significant .
-RESULTS	Odds ratios ( 95 % confidence intervals ) of incident CKD ( < 60 ml/min per 1.73 m ( 2 ) ) and rapid decline of kidney function ( 3 ml/min per year ) for eicosapentaenoic acid-docosahexaenoic acid compared with placebo were 0.83 ( 0.58 to 1.18 ) and 0.85 ( 0.67 to 1.08 ) , respectively .
-CONCLUSIONS	Long-term supplementation with 400 mg/d eicosapentaenoic acid-docosahexaenoic acid provides a small beneficial effect on kidney function in patients with a history of myocardial infarction .
-
-###24933496
-OBJECTIVE	Many service members do not seek care for mental health and addiction problems , often with serious consequences for them , their families , and their communities .
-OBJECTIVE	This study tested the effectiveness of a brief , telephone-based , cognitive-behavioral intervention designed to improve treatment engagement among returning service members who screened positive for posttraumatic stress disorder ( PTSD ) .
-METHODS	Service members who had served in Operation Enduring Freedom or Operation Iraqi Freedom who screened positive for PTSD but had not engaged in PTSD treatment were recruited ( N = 300 ) , randomly assigned to either control or intervention conditions , and administered a baseline interview .
-METHODS	Intervention participants received a brief cognitive-behavioral therapy intervention ; participants in the control condition had access to usual services .
-METHODS	All participants received follow-up phone calls at months 1 , 3 , and 6 to assess symptoms and service utilization .
-RESULTS	Participants in both conditions had comparable rates of treatment engagement and PTSD symptom reduction over the course of the six-month trial , but receiving the telephone-based intervention accelerated service utilization ( treatment engagement and number of sessions ) and PTSD symptom reduction .
-CONCLUSIONS	A one-time brief telephone intervention can engage service members in PTSD treatment earlier than conventional methods and can lead to immediate symptom reduction .
-CONCLUSIONS	There were no differences at longer-term follow-up , suggesting the need for additional intervention to build upon initial gains .
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-###25972257
-OBJECTIVE	To evaluate whether dietary intake of luteiin/zeaxanthin and B vitamins is associated with cataract prevalence and incidence .
-METHODS	Clinic-based , baseline cross-sectional and prospective cohort study designs .
-METHODS	Three thousand one hundred fifteen patients ( 6129 eyes ) enrolled in the Age-Related Eye Disease Study 55 to 80 years of age followed up for mean of 9.6 years .
-METHODS	Participants completed baseline food frequency questionnaires .
-METHODS	Baseline and annual lens photographs were graded centrally .
-METHODS	Multivariate models controlling for previously identified risk factors for cataracts tested for the association of cataracts with reported dietary intake , using the lowest quintile as reference .
-METHODS	Cataract surgery , cataract status ( type and severity ) at baseline , and development of cataracts .
-RESULTS	At baseline , increased dietary riboflavin and B12 were associated inversely with nuclear and cortical lens opacities .
-RESULTS	In comparisons of persons with and without cataract , persons with the highest riboflavin intake versus those with the lowest intake had the following associations : mild nuclear cataract : odds ratio ( OR ) , 0.78 ; 95 % confidence interval ( CI ) , 0.63-0 .97 ; moderate nuclear cataract : OR , 0.62 ; 95 % CI , 0.43-0 .90 ; and mild cortical cataract : OR , 0.80 ; 95 % CI , 0.65-0 .99 .
-RESULTS	For B12 , the results were : mild nuclear cataract : OR , 0.78 ; 95 % CI , 0.63-0 .96 ; moderate nuclear cataract : OR , 0.62 ; 95 % CI , 0.43-0 .88 ; and mild cortical cataract : OR , 0.77 ; 95 % CI , 0.63-0 .95 .
-RESULTS	Highest dietary B6 intake was associated with a decreased risk of moderate nuclear lens opacity developing compared with the lowest quintile ( OR , 0.67 ; 95 % CI , 0.45-0 .99 ) .
-RESULTS	Highest dietary intake levels of niacin and B12 were associated with a decreased risk of development of mild nuclear or mild cortical cataracts in participants not taking Centrum ( Pfizer , New York , NY ) multivitamins .
-RESULTS	For participants taking multivitamins during the study , the highest intake of dietary folate was associated with an increased risk of mild posterior subcapsular lens opacity development .
-RESULTS	No statistically significant associations were found between lutein plus zeaxanthin intake and presence at baseline or development of nuclear or cortical lens opacity outcomes .
-CONCLUSIONS	These findings are consistent with earlier studies suggesting that dietary intake of B vitamins may affect the occurrence of age-related lens opacities .
-CONCLUSIONS	Further investigations are warranted .
-
-###24999282
-OBJECTIVE	Latrodectism is the most important spider envenomation syndrome worldwide .
-OBJECTIVE	There remains considerable controversy over antivenom treatment .
-OBJECTIVE	We aimed to investigate whether antivenom resulted in resolution of pain and systemic effects in patients with latrodectism who received standardized analgesia .
-METHODS	In a multicenter randomized placebo-controlled trial of redback spider antivenom for latrodectism , 224 patients ( > 7 years ) with a redback spider bite and severe pain , with or without systemic effects , were randomized to receive normal saline solution ( placebo ) or antivenom after receiving standardized analgesia .
-METHODS	The primary outcome was a clinically significant reduction in pain 2 hours after trial medication compared with baseline .
-METHODS	A second primary outcome for the subgroup with systemic features of envenomation was resolution of systemic features at 2 hours .
-METHODS	Secondary outcomes were improved pain at 4 and 24 hours , resolution of systemic features at 4 hours , administration of opioid analgesics or unblinded antivenom after 2 hours , and adverse reactions .
-RESULTS	Two hours after treatment , 26 of 112 patients ( 23 % ) from the placebo arm had a clinically significant improvement in pain versus 38 of 112 ( 34 % ) from the antivenom arm ( difference in favor of antivenom 10.7 % ; 95 % confidence interval -1.1 % to 22.6 % ; P = .10 ) .
-RESULTS	Systemic effects resolved after 2 hours in 9 of 41 patients ( 22 % ) in the placebo arm and 9 of 35 ( 26 % ) in the antivenom arm ( difference 3.8 % ; 95 % confidence interval -15 % to 23 % ; P = .79 ) .
-RESULTS	There was no significant difference in any secondary outcome between antivenom and placebo .
-RESULTS	Acute systemic hypersensitivity reactions occurred in 4 of 112 patients ( 3.6 % ) receiving antivenom .
-CONCLUSIONS	The addition of antivenom to standardized analgesia in patients with latrodectism did not significantly improve pain or systemic effects .
-
-###25732415
-OBJECTIVE	Although screening colonoscopy is effective in preventing distal colon cancers , effectiveness in preventing right-sided colon cancers is less clear .
-OBJECTIVE	Previous studies have reported that retroflexion in the right colon improves adenoma detection .
-OBJECTIVE	We aimed to determine whether a second withdrawal from the right colon in retroflexion vs. forward view alone leads to the detection of additional adenomas .
-METHODS	Patients undergoing screening or surveillance colonoscopy were invited to participate in a parallel , randomized , controlled trial at two centers .
-METHODS	After cecal intubation , the colonoscope was withdrawn to the hepatic flexure , all visualized polyps removed , and endoscopist confidence recorded on a 5-point Likert scale .
-METHODS	Patients were randomized to a second exam of the proximal colon in forward ( FV ) or retroflexion view ( RV ) , and adenoma detection rates ( ADRs ) compared .
-METHODS	Logistic regression analysis was used to evaluate predictors of identifying adenomas on the second withdrawal from the proximal colon .
-RESULTS	A total of 850 patients ( mean age 59.18.3 years , 59 % female ) were randomly assigned to FV ( N = 400 ) or RV ( N = 450 ) .
-RESULTS	Retroflexion was successful in 93.5 % .
-RESULTS	The ADR ( 46 % FV and 47 % RV ) and numbers of adenomas per patient ( 0.91.4 FV and 1.12.1 RV ) were similar ( P = 0.75 for both ) .
-RESULTS	At least one additional adenoma was detected on second withdrawal in similar proportions ( 10.5 % FV and 7.5 % RV , P = 0.13 ) .
-RESULTS	Predictors of identifying adenomas on the second withdrawal included older age ( odds ratio ( OR ) = 1.04 , 95 % confidence interval ( CI ) = 1.01-1 .08 ) , adenomas seen on initial withdrawal ( OR = 2.8 , 95 % CI = 1.7-4 .7 ) , and low endoscopist confidence in quality of first examination of the right colon ( OR = 4.8 , 95 % CI = 1.9-12 .1 ) .
-RESULTS	There were no adverse events .
-CONCLUSIONS	Retroflexion in the right colon can be safely achieved in the majority of patients undergoing colonoscopy for colorectal cancer screening .
-CONCLUSIONS	Reexamination of the right colon in either retroflexed or forward view yielded similar , incremental ADRs .
-CONCLUSIONS	A second exam of the right colon should be strongly considered in patients who have adenomas discovered in the right colon , particularly when endoscopist confidence in the quality of initial examination is low .
-
-###24301236
-BACKGROUND	Botulinum toxin type A ( BoNT-A ) has been used for almost 20 years in cosmetic dermatology to reduce dynamic wrinkles on single or multiple facial areas .
-OBJECTIVE	To evaluate the safety and efficacy of full-face treatments with various total doses of abobotulinum toxin A ( ABO ) .
-METHODS	A total of 90 participants were enrolled .
-METHODS	Subjects had at least two indications for BoNT-A treatments on each third of the face ( upper , middle and lower ) .
-METHODS	They were randomized into 3 groups , with pre-defined total dose range of ABO , varying from 120 to 250 U.
-RESULTS	Most of the subjects were women ( 96.5 % ) .
-RESULTS	The statistically significant improvement from baseline lasted for more than 24 weeks for glabellar lines , and more than 16 weeks for forehead wrinkles and crow 's feet , all P < 0.001 , with no differences between groups .
-RESULTS	The most frequent adverse event ( excessive perioral weakness ) was related to high dose in the perioral area .
-CONCLUSIONS	This is the first study to compare safety and efficacy of different doses of ABO administered to the entire face simultaneously .
-CONCLUSIONS	As long as the recommended doses are used , concomitant injections of ABO are safe and efficient , with no increase in adverse events .
-
-###24745637
-BACKGROUND	Because of frequent exposure to tick habitats , outdoor workers are at high risk for tick-borne diseases .
-BACKGROUND	Adherence to National Institute for Occupational Safety and Health-recommended tick bite prevention methods is poor .
-BACKGROUND	A factory-based method for permethrin impregnation of clothing that provides long-lasting insecticidal and repellent activity is commercially available , and studies are needed to assess the long-term effectiveness of this clothing under field conditions .
-OBJECTIVE	To evaluate the protective effectiveness of long-lasting permethrin impregnated uniforms among a cohort of North Carolina outdoor workers .
-METHODS	A double-blind RCT was conducted between March 2011 and September 2012 .
-METHODS	Subjects included outdoor workers from North Carolina State Divisions of Forestry , Parks and Recreation , and Wildlife who worked in eastern or central North Carolina .
-METHODS	A total of 159 volunteer subjects were randomized , and 127 and 101 subjects completed the first and second years of follow-up , respectively .
-METHODS	Uniforms of participants in the treatment group were factory-impregnated with long-lasting permethrin whereas control group uniforms received a sham treatment .
-METHODS	Participants continued to engage in their usual tick bite prevention activities .
-METHODS	Incidence of work-related tick bites reported on weekly tick bite logs .
-RESULTS	Study subjects reported 1,045 work-related tick bites over 5,251 person-weeks of follow-up .
-RESULTS	The mean number of reported tick bites in the year prior to enrollment was similar for both the treatment and control groups , but markedly different during the study period .
-RESULTS	In our analysis conducted in 2013 , the effectiveness of long-lasting permethrin impregnated uniforms for the prevention of work-related tick bites was 0.82 ( 95 % CI = 0.66 , 0.91 ) and 0.34 ( 95 % CI = -0.67 , 0.74 ) for the first and second years of follow-up .
-CONCLUSIONS	These results indicate that long-lasting permethrin impregnated uniforms are highly effective for at least 1 year in deterring tick bites in the context of typical tick bite prevention measures employed by outdoor workers .
-
-###24464385
-BACKGROUND	Natural orifice transluminal endoscopic surgery ( NOTES ) has the potential to reduce postoperative pain .
-BACKGROUND	We compared postoperative pain in the hybrid NOTES procedure transvaginal video-assisted cholecystectomy ( TVC ) with standard conventional laparoscopic cholecystectomy ( CLC ) .
-METHODS	Single-center , double-blind , randomized controlled trial in a level II hospital between June 2008 and June 2012 .
-METHODS	Female patients , older than 18 years of age with symptomatic cholecystolithiasis were randomized to receive either TVC or CLC .
-METHODS	The follow-up period was 7 days and the primary outcome of the study was postoperative pain .
-METHODS	We hypothesized that there is no reduction of pain ( Visual Rating Scale 1 ) while resting or coughing over a 48-h period after the operation .
-METHODS	Secondary outcome included wound infections , complications , and patient reported outcomes .
-METHODS	Sealed envelopes with computer-generated randomization information were kept for allocation in theater .
-METHODS	All patients received opaque wound dressing , as in standard four-trocar cholecystectomy and a vaginal tamponade .
-METHODS	Theater protocol and surgical notes were kept separate after the procedure .
-RESULTS	Overall , 97 of 426 patients assessed for participation were randomized for either TVC or CLC .
-RESULTS	A total of 41 patients had a TVC and 51 had a CLC .
-RESULTS	Five patients were excluded from the analysis .
-RESULTS	There was no difference in age , body mass index , American Society of Anesthesiologists ( ASA ) grade , or hospital stay , but anesthetic and surgical times were significantly longer in TVC ( p < 0.001 ) .
-RESULTS	There was no statistical difference in postoperative pain between the two groups while resting or coughing .
-RESULTS	Complications included conversion to laparotomy , bleeding , wound infections , and re-admission .
-RESULTS	No difference in the rate of complications between the two groups was seen .
-RESULTS	Overall , 86 and 93 % of CLC and TVC patients , respectively , would recommend the procedure to other patients .
-CONCLUSIONS	In this study , no significant difference in pain on days 1 and 2 postoperatively between the two methods was found .
-CONCLUSIONS	The safety profile of TVC is comparable to CLC , and TVC patients would generally recommend this procedure to other patients .
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-###25573150
-OBJECTIVE	To compare the change in iris-trabecular contact ( ITC ) area using swept-source optical coherence tomography ( SS-OCT ) in eyes with primary angle closure glaucoma ( PACG ) and cataract that underwent phacoemulsification ( PE ) with intraocular lens implantation alone compared with PE with goniosynechialysis ( GSL ) .
-METHODS	One eye of 22 patients with PACG with peripheral anterior synechiae ( PAS ) detected by indentation gonioscopy was randomised into two groups ( PE alone ( n = 11 ) and PE+GSL ( n = 11 ) ) .
-METHODS	The anterior chamber angles were evaluated by SS-OCT under dark conditions before and 12months after surgery using the three-dimensional angle analysis scan protocol that simultaneously obtains 128 cross-sectional radial scans across the anterior chamber at equal intervals ( every 1.4 ) .
-METHODS	The ITC area , defined as the area of extent of the circumferential contact of peripheral iris to the angle wall , was computed automatically by SS-OCT after an observer marked the scleral spurs of all 128 scans of each eye .
-RESULTS	The majority of the 22 subjects were women ( 77.3 % ) and the meanSD age was 67.35.8 years .
-RESULTS	The ITC area was significantly reduced in the PE+GSL group compared with the PE alone group ( 10.2 mm2 vs. 4.6 mm2 , = 0.54 , p = 0.03 ) after adjusting for age , gender , intraocular pressure , extent of PAS and pupil diameter before surgery .
-RESULTS	Smaller iris volume at baseline was associated with greater ITC area reduction by PE+GSL ( = -0.728 , p = 0.03 ) .
-CONCLUSIONS	Eyes that undergo PE+GSL surgery have a greater reduction in circumferential ITC area than eyes that undergo PE alone .
-
-###24274798
-OBJECTIVE	Prior research supports the hypothesis that cancer survivors who help others face treatment experience a range of psychosocial and health-related benefits as a result of peer helping .
-OBJECTIVE	This study investigates an expressive helping ( EH ) intervention designed to harness those benefits by targeting survivorship problems among cancer survivors treated with hematopoietic stem cell transplant .
-OBJECTIVE	EH includes two components : ( a ) emotionally expressive writing ( EW ; writing one 's deepest thoughts and feelings about the transplant experience in a series of brief , structured writing sessions ) followed by ( b ) peer helping ( PH ; helping other people prepare for transplant by sharing one 's own transplant experiences along with advice and encouragement through a written narrative ) .
-METHODS	EH was compared with neutral writing ( NW ) , EW ( without PH ) , and PH ( without EW ) in a 4-arm randomized controlled trial in which survivors completed baseline measures , 4 structured writing exercises ( with instructions depending on randomization ) , and postintervention measures including validated measures of general psychological distress , physical symptoms , and health-related quality of life ( HRQOL ) .
-RESULTS	Among survivors with moderate-severe survivorship problems , EH reduced distress ( compared with NW and PH ; ps < .05 ) and improved physical symptoms ( compared with NW , PH , and EW ; ps < .002 ) and HRQOL ( compared with NW ; p = .02 ) .
-CONCLUSIONS	Peer helping through writing benefits transplant survivors with moderate-severe survivorship problems , but only if they have first completed expressive writing .
-
-###25400062
-BACKGROUND	The TAXUS Libert Post Approval Study ( TL-PAS ) contributed patients treated with TAXUS Libert paclitaxel-eluting stent and prasugrel to the Dual Antiplatelet Therapy Study ( DAPT ) that compared 12 and 30 months thienopyridine plus aspirin therapy after drug-eluting stents .
-RESULTS	Outcomes for 2191 TL-PAS patients enrolled into DAPT were assessed .
-RESULTS	The DAPT coprimary composite end point ( death , myocardial infarction [ MI ] , or stroke ) was lower with 30 compared with 12 months prasugrel treatment ( 3.7 % versus 8.8 % ; hazard ratio [ HR ] , 0.407 ; P < 0.001 ) .
-RESULTS	Rates of death and stroke were similar between groups , but MI was significantly reduced with prolonged prasugrel treatment ( 1.9 % versus 7.1 % ; HR , 0.255 ; P < 0.001 ) .
-RESULTS	The DAPT coprimary end point , stent thrombosis , was also lower with longer therapy ( 0.2 % versus 2.9 % ; HR , 0.063 ; P < 0.001 ) .
-RESULTS	MI related to stent thrombosis ( 0 % versus 2.6 % ; P < 0.001 ) and occurring spontaneously ( 1.9 % versus 4.5 % ; HR , 0.407 ; P = 0.007 ) were both reduced with prolonged prasugrel .
-RESULTS	MI rates increased within 90 days of prasugrel cessation after both 12 and 30 months treatment .
-RESULTS	Composite Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries ( GUSTO ) moderate or severe bleeds were modestly increased ( 2.4 % versus 1.7 % ; HR , 1.438 ; P = 0.234 ) but severe bleeds were not more frequent ( 0.3 % versus 0.5 % ; HR , 0.549 ; P = 0.471 ) in the prolonged treatment group .
-CONCLUSIONS	Prasugrel and aspirin continued for 30 months reduced ischemic events for the TAXUS Libert paclitaxel-eluting stent patient subset from DAPT through reductions in MI and stent thrombosis .
-CONCLUSIONS	Withdrawal of prasugrel was followed by an increase in MI after both 12 and 30 months therapy .
-CONCLUSIONS	The optimal duration of dual antiplatelet therapy with prasugrel after TAXUS Libert paclitaxel-eluting stent remains unknown , but appears to be > 30 months .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00997503 .
-
-###24658476
-BACKGROUND	In the cervical spine , the ligamentum flavum ( LF ) is often incompletely fused at the midline .
-BACKGROUND	Therefore , accessing the epidural space ( ES ) using the loss of resistance ( LOR ) technique via the midline approach could be less reliable than the paramedian approach .
-BACKGROUND	Since the tactile sensation of LOR is due to abrupt loss of pressure upon entering the ES , we have compared pressure changes between the 2 different cervical epidural techniques .
-OBJECTIVE	The aim of this study was to compare pressure changes during the pathway to the cervical ES between the 2 approaches .
-METHODS	A prospective , open-labeled , randomized , comparative study .
-METHODS	An interventional pain management practice in a hospital , Republic of Korea .
-METHODS	The 74 patients were randomly assigned to either a midline or paramedian group .
-METHODS	The pressure changes were monitored and classified into 4 grades according to the following criteria : Grade I.
-METHODS	The pressure waveform sequence consisted of 3 components in chronological order : 1 ) a high positive pressure just prior to entering the ES ; 2 ) an abrupt pressure decrease at the moment of entering the ES ; and 3 ) a negative peak pressure before cervical epidural pressure equilibration .
-METHODS	Grade II .
-METHODS	A high positive pressure followed by a precipitous pressure drop , without negative peak pressure upon entering the ES .
-METHODS	Grade III .
-METHODS	High positive pressure before entering the ES , followed by continuous pressure decrease without negative pressure .
-METHODS	Grade IV .
-METHODS	No pressure changes before or after entering the cervical ES .
-RESULTS	An abrupt pressure decrease at the moment of exiting the LF or entering the ES was more frequently observed when using the paramedian approach ( P < 0.05 ) with the odds ratio of 4.96 ( 95 % CI , 1.63 - 15.12 ) as compared with the midline approach .
-CONCLUSIONS	A correlation between the abrupt pressure decrease and LOR tactile sensation has been assumed .
-CONCLUSIONS	Under the assumption that the LOR sensation is due to an abrupt decrease in pressure the moment the needle enters the ES or exits the LF , this study claims that the accuracy of accessing the cervical ES can be improved significantly using the paramedian approach .
-BACKGROUND	NCT01009385 .
-BACKGROUND	Institutional Review Board ( IRB ) : H-1208-107-422 .
-
-###26480546
-OBJECTIVE	To compare the difference in depression relief in the treatment of depressive disorder at the acute stage between the combined therapy of acupuncture and 5-HT ( 5-hydroxytryptamine ) selective serotonini reuptake inhibitors ( SSRIs ) and the single application of SSRIs and explore the impact on the imbalance of 5-HT and TH1/TH2 .
-METHODS	Ninety cases of depressive disorder at the acute stage were randomized into a combined therapy group and a medication group , 45 cases in each one .
-METHODS	In the medication group , SSRIs were prescribed forl oral administration , once or twice a day , continuously for 4 weeks .
-METHODS	In the combined therapy group , on the basis of treatment as the medication group , acupuncture was combined .
-METHODS	The main acupoints were Baihui ( GV 20 ) , Yintang ( GV 29 ) , Shenting ( GV 24 ) , Fengchi ( GB 20 ) , Dazhui ( GV 14 ) and Sishencong ( EX-HN 1 ) , once every two .
-METHODS	days , continuously for 4 weeks .
-METHODS	Before treatment , and after the 1st , 2nd and 4th weeks of treatment , the Hamilton depression scale ( HAMD ) was used to evaluate the depression severity .
-METHODS	Separately , before and after the 4 weeks of treatment , the levels of serum 5-HT , interleukin-1 beta ( IL-1 ) , interleukin-6 ( IL-6 ) , interleukin-4 ( IL-4 ) and interleukin-10 ( IL-10 ) were determined and compared with those in 45 cases of the healthy group .
-RESULTS	HAMD score was reduced in the 1st , 2nd and 4th weeks of treatment as compared with that before treatment in the combined therapy group ( all P < 0 01 ) .
-RESULTS	HAMD score was reduced in the 2nd and 4th weeks of treatment as compared with that before treatment in the medication group ( all P < 0.01 ) .
-RESULTS	HAMD scores in the combined therapy group were lower than those in the medication group in the 1st , 2nd and 4th weeks of treatment ( all P < 0.01 ) .
-RESULTS	Before treatment , in the combined therapy group and the medication group , the levels of serum 5-HT , IL-4 and IL-10 were all lower than those in the healthy group ( all P < 0.01 ) ; the levels of IL-1 and IL-6 were higher than those in the healthy group ( all P < 0.01 ) .
-RESULTS	In the combined therapy group and the medication group , the levels of 5-HT , IL-4 and IL-10 in 4 weeks of treatment were all increased as compared with those before treatment ( all P < 0.01 ) , and the levels of IL-1 and IL-6 were lower than those before treatment ( all P < 0.01 ) .
-RESULTS	In the combined therapy group , the levels of IL-1 and IL-6 in 4 weeks of treatment were lower than those in the medication group , and the levels of 5-HT , IL-4 and IL-10 were higher than those in the medication group ( P < 0.01 , P < 0.05 ) .
-CONCLUSIONS	The combined therapy of acupuncture and SSRIs achieves much quicker and more effective re - ' sult for relieving depression in the patients of depressive disorder as compared with simple oral administration of ' SSRIs , and much more contributes to adjust the imbalance of serum 5-HT and TH1/TH2 .
-
-###26099869
-OBJECTIVE	To determine whether the use of 3-dimensional ( 3D ) imaging translates into a better surgical performance of nave urologic laparoscopic surgeons during pyeloplasty ( PY ) and partial nephrectomy ( PN ) procedures .
-METHODS	Eighteen surgeons without any previous laparoscopic experience were randomly assigned to perform PY and PN in a porcine model using initially 2-dimensional ( 2D ) and 3D laparoscopy .
-METHODS	A surgical performance score was rated by an `` expert '' tutor through a modified 5-item global rating scale contemplating operative field view , bimanual dexterity , efficiency , tissue handling , and autonomy .
-METHODS	Overall surgical time , complications , subjective perception of participating surgeons , and inconveniences related to the 3D vision were recorded .
-RESULTS	No difference in terms if operative time was found between 2D or 3D laparoscopy for both the PY ( P = .51 ) and the PN ( P = .28 ) procedures .
-RESULTS	A better rate in terms of surgical performance score was noted by the tutors when the study participants were using 3D vs 2D , for both PY ( 3.6 [ 0.8 ] vs 3.0 [ 0.4 ] ; P = .034 ) and PN ( 3.6 [ 0.51 ] vs 3.15 [ 0.63 ] ; P = .001 ) .
-RESULTS	No complications occurred in any of the procedures .
-RESULTS	Most ( 77.2 % ) of the participating nave laparoscopic surgeons had the perception that 3D laparoscopy was overall easier than 2D .
-RESULTS	Headache ( 18.1 % ) , nausea ( 18.1 % ) , and visual disturbance ( 18.1 % ) were the most common issues reported by the surgeons during 3D procedures .
-CONCLUSIONS	Despite the absence of translation in a shorter operative time , the use of 3D technology seems to facilitate the surgical performance of nave surgeons during laparoscopic kidney procedures on a porcine model .
-
-###24337348
-OBJECTIVE	To evaluate the long-term effects of radiofrequency ablation ( RFA ) of renal masses ( RM ) and compare them with surgery .
-METHODS	A total of 203 RM ( 193 malignant ; mean size 30 mm ) in 137 patients ( 95 male subjects ; average age 64 years ) underwent RFA .
-METHODS	Complications and technique effectiveness were evaluated .
-METHODS	Overall survival , cancer-specific survival , and disease-free survival were calculated ( mean follow-up time 39 months ) .
-METHODS	Predictors for complications , technique effectiveness , and survival were investigated .
-RESULTS	Seventeen ( 8.4 % ) adverse events were recorded ( 2 % major complications ) .
-RESULTS	Exophytic development and smaller size were protective against adverse events .
-RESULTS	Complete ablation was obtained in 87 % RM ( 93 % 3 cm , 89 % 4 cm ) .
-RESULTS	T1a threshold was a positive predictor for complete ablation and central location a negative one .
-RESULTS	Three - and 5-year overall survival were 84 and 75 % ; cancer-specific survival 96 and 91 % ; and disease-free survival 80 and 75 % .
-RESULTS	Considering only the 79 patients with newly diagnosed renal cell carcinoma , T1a disease stage resulted a positive predictor for both overall survival ( 87 and 83 % at 3 and 5 years ) and cancer-specific survival ( 100 % at 5 years ) .
-CONCLUSIONS	RFA of noncentral small RM is safe and effective , and it provides favorable long-term oncological outcomes .
-CONCLUSIONS	Selection criteria for RFA can also include T1a renal cell carcinoma in patients without surgical contraindications , even though randomized controlled trials are needed to establish the best treatment .
-
-###24714403
-OBJECTIVE	To compare the free-hand ( FH ) technique of placing interlocking screws to a commercially available electromagnetic ( EM ) targeting system in terms of operating time , radiation dose , and accuracy of screw placement .
-METHODS	Between September 2011 and July 2012 , we prospectively randomized 100 consecutive femur shaft fractures in 99 patients requiring intramedullary nails to either FH using fluoroscopy ( n = 43 ) or EM targeting ( n = 38 ; Sureshot ) .
-METHODS	Single Level 1 University Hospital Trauma Center .
-METHODS	The 2 groups were assessed for distal locking with respect to time , radiation , and accuracy .
-RESULTS	Eight-one fractures had data accurately recorded ( 38 EM/43 FH ) .
-RESULTS	The average total operative time was 50 minutes ( range , 25-88 minutes ; SD , 13.9 minutes ) for the FH group and 57 minutes ( range , 40-103 minutes ; SD , 16.12 minutes ) for the EM group .
-RESULTS	The average time for distal locking was 10 minutes ( range , 4-16 minutes ; SD , 3.56 minutes ) with FH and 11 minutes ( range , 6-28 minutes ; SD , 10.24 minutes ) with EM .
-RESULTS	Average radiation dose for distal locking was significantly less ( P < 0.0001 ) for EM at 230.54 Gy ( range , 51-660 Gy ; SD , 0.17 Gy ) compared with 690.27 Gy ( range , 200-2310 Gy ; SD , 0.52 Gy ) for FH .
-RESULTS	There were 2 misplaced drill bits in FH and 3 in EM .
-RESULTS	This was not statistically significant ( P = 0.888 ) .
-CONCLUSIONS	The electromagnetic targeting device ( Sureshot ) significantly reduced radiation exposure during placement of distal interlocking screws , without sacrificing operative time , and was equivalent in accuracy when compared with the FH technique .
-METHODS	Therapeutic level II .
-
-###24884684
-BACKGROUND	The resin-based pit and fissure sealant is considered a successful tool in caries prevention , however there is a growing evidence of its use in controlling already established caries in posterior teeth .
-BACKGROUND	The aim of this clinical trial is to verify the efficacy of pit and fissure sealants in arresting dentinal caries lesions compared to partial excavation and restorative treatment in primary molar teeth .
-METHODS	Thirty six patients with occlusal cavitated primary molar reaching outer half of dentin were selected .
-METHODS	The patients were randomly allocated into two groups : sealant application ( experimental group - n = 17 ) and restoration with composite resin ( control group - n = 19 ) .
-METHODS	Clinical and radiograph evaluation were performed after 6 , 12 and 18 months .
-METHODS	The chi-square test was used to verify the distribution of characteristics variables of the sample among the groups .
-METHODS	The survival rate of treatments was evaluated using Kaplan-Meier survival and log-rank test .
-METHODS	Fisher 's Exact and logistic regression tests were calculated in each evaluation period ( = 5 % ) .
-RESULTS	The control group showed significantly better clinical survival after 18 months ( p = 0.0025 ) .
-RESULTS	In both groups , no caries progression was registered on the radiographic evaluations .
-CONCLUSIONS	Sealing had similar efficacy in the arrestment of caries progression of cavitated occlusal lesions compared to partial excavation of the lesions , even though the frequency of re-treatments was significantly higher in sealed lesions .
-BACKGROUND	Registro Brasileiro de Ensaios Clnicos ( ReBEC ) : RBR-9kkv53 .
-
-###25342641
-BACKGROUND	A previous randomised controlled trial that investigated Assertive Community Treatment ( ACT ) in the UK ( the REACT Study ) found no clinical advantage over usual care delivered by Community Mental Health Teams ( CMHTs ) at 18 and 36 month follow-ups .
-BACKGROUND	No studies have investigated long term clinical and social outcomes for patients receiving ACT .
-METHODS	We investigated inpatient service use , social outcomes , service contact and adverse events for the 251 REACT study participants 10 years after randomisation through case note review .
-METHODS	Data were analysed using regression models adjusted for original treatment group allocation and changes in treatment group .
-RESULTS	We found no statistically significant differences in outcomes by original treatment group over the 10 years .
-RESULTS	Those whose care remained with ACT , or transferred to ACT or forensic services , had more inpatient days over the 10 years ( coefficient 223 , 95 % CI 83 to 363 , p = 0.002 ) than those whose care remained with the CMHTs or were discharged to primary care .
-RESULTS	Being subject to a Community Treatment Order was associated with a greater chance of being under ACT at 10 year follow-up ( OR 6.39 , 95 % CI 2.98 to 13.70 , p < 0.001 ) .
-CONCLUSIONS	The ACT teams in this study showed no clinical advantage over usual care provided by CMHTs at 10 year follow-up .
-CONCLUSIONS	We also found that the ACT teams accrued patients from the original study sample who had more complex needs than those who remained with or transferred to the CMHTs or primary care during this period .
-CONCLUSIONS	Further well conducted trials are needed to identify the most cost-effective approaches to supporting successful community living and optimum long term outcomes for this group .
-
-###24885844
-BACKGROUND	The percentage of older and chronically ill workers is increasing rapidly in the US and in many other countries , but few interventions are available to help employees overcome the workplace challenges of chronic pain and other physical health conditions .
-BACKGROUND	While most workers are eligible for job accommodation and disability compensation benefits , other workplace strategies might improve individual-level coping and problem solving to prevent work disability .
-BACKGROUND	In this study , we hypothesize that an employer-sponsored group intervention program employing self-management principles may improve worker engagement and reduce functional limitation associated with chronic disorders .
-METHODS	In a randomized controlled trial ( RCT ) , workers participating in an employer-sponsored self-management group intervention will be compared with a no-treatment ( wait list ) control condition .
-METHODS	Volunteer employees ( n = 300 ) will be recruited from five participating employers and randomly assigned to intervention or control .
-METHODS	Participants in the intervention arm will attend facilitated group workshop sessions at work ( 10 hours total ) to explore methods for improving comfort , adjusting work habits , communicating needs effectively , applying systematic problem solving , and dealing with negative thoughts and emotions about work .
-METHODS	Work engagement and work limitation are the principal outcomes .
-METHODS	Secondary outcomes include fatigue , job satisfaction , self-efficacy , turnover intention , sickness absence , and health care utilization .
-METHODS	Measurements will be taken at baseline , 6 - , and 12-month follow-up .
-METHODS	A process evaluation will be performed alongside the randomized trial .
-CONCLUSIONS	This study will be most relevant for organizations and occupational settings where some degree of job flexibility , leeway , and decision-making autonomy can be afforded to affected workers .
-CONCLUSIONS	The study design will provide initial assessment of a novel workplace approach and to understand factors affecting its feasibility and effectiveness .
-BACKGROUND	Clinicaltrials.gov : NCT01978392 ( Issued November 6 , 2013 ) .
-
-###25724847
-BACKGROUND	Asthma exacerbations are commonly precipitated by viral upper respiratory infections ( URIs ) .
-BACKGROUND	Vitamin D insufficiency associates with susceptibility to URI in patients with asthma .
-BACKGROUND	Trials of vitamin D in adults with asthma with incidence of exacerbation and URI as primary outcome are lacking .
-OBJECTIVE	To conduct a randomised controlled trial of vitamin D3 supplementation for the prevention of asthma exacerbation and URI ( coprimary outcomes ) .
-METHODS	250 adults with asthma in London , UK were allocated to receive six 2-monthly oral doses of 3mg vitamin D3 ( n = 125 ) or placebo ( n = 125 ) over 1year .
-METHODS	Secondary outcomes included asthma control test and St George 's Respiratory Questionnaire scores , fractional exhaled nitric oxide and concentrations of inflammatory markers in induced sputum .
-METHODS	Subgroup analyses were performed to determine whether effects of supplementation were modified by baseline vitamin D status or genotype for 34 single nucleotide polymorphisms in 11 vitamin D pathway genes .
-RESULTS	206/250 participants ( 82 % ) were vitamin D insufficient at baseline .
-RESULTS	Vitamin D3 did not influence time to first severe exacerbation ( adjusted HR 1.02 , 95 % CI 0.69 to 1.53 , p = 0.91 ) or first URI ( adjusted HR 0.87 , 95 % CI 0.64 to 1.16 , p = 0.34 ) .
-RESULTS	No clinically important effect of vitamin D3 was seen on any of the secondary outcomes listed above .
-RESULTS	The influence of vitamin D3 on coprimary outcomes was not modified by baseline vitamin D status or genotype .
-CONCLUSIONS	Bolus-dose vitamin D3 supplementation did not influence time to exacerbation or URI in a population of adults with asthma with a high prevalence of baseline vitamin D insufficiency .
-BACKGROUND	NCT00978315 ( ClinicalTrials.gov ) .
-
-###24448692
-BACKGROUND	Topiroxostat , a selective xanthine oxidase inhibitor , shows effective reduction in the serum urate level in hyperuricemic patients with or without gout .
-BACKGROUND	The objective of this study was to evaluate the efficacy and safety of topiroxostat in hyperuricemic stage 3 chronic kidney disease patients with or without gout .
-METHODS	The study design was a 22-week , randomized , multicenter , double-blind study .
-METHODS	The enrolled patients were randomly assigned to treatment with topiroxostat 160 mg/day ( n = 62 ) or to the placebo ( n = 61 ) .
-METHODS	The endpoints were the percent change in the serum urate level , change in the estimated glomerular filtration rate , the urinary albumin-to-creatinine ratio , the proportion of patients with serum urate levels of 356.88 mol/L or less , blood pressure , and serum adiponectin .
-RESULTS	After 22 weeks , although the changes in the estimated glomerular filtration rate and blood pressure were not significant , the percent change in the serum urate level ( -45.38 vs. -0.08 % , P < 0.0001 ) and the percent change in urinary albumin-to-creatinine ratio ( -33.0 vs. -6.0 % , P = 0.0092 ) were found to have decreased in the topiroxostat as compared with the placebo .
-RESULTS	Although the incidence of ` alanine aminotransferase increased ' was higher in the topiroxostat , serious adverse event rates were similar in the two groups .
-CONCLUSIONS	Topiroxostat 160 mg effectively reduced the serum urate level in the hyperuricemic stage 3 chronic kidney disease patients with or without gout .
-
-###25203377
-OBJECTIVE	The aim of this study was to compare the ligation of the intersphincteric fistula track with the mucosal advancement flap in the treatment of high transsphincteric anal fistulas .
-METHODS	This was a prospective randomized study performed at academic medical centers .
-METHODS	Patients with transsphincteric anal fistulas involving the upper part of anal sphincter were included .
-METHODS	Patients were randomly assigned to either ligation of intersphincteric fistula track or mucosal advancement flap .
-METHODS	The primary end points of the study were fistula closure , recurrence within 1 year , and continence by using the Wexner score .
-METHODS	Secondary end points were morbidity , postoperative pain with the use of the visual analog scale , and quality of life with the use of the Cleveland Global Quality of Life score .
-RESULTS	There were 70 patients ( 35 in each group ) .
-RESULTS	Mean age was 36.1 years in patients undergoing ligation of the intersphincteric fistula track vs 32.9 years in patients undergoing mucosal advancement flap ( p = 0.33 ) .
-RESULTS	Mean visual analog scale after 1 week was significantly higher in the mucosal advancement flap group than in the ligation of intersphincteric fistula track group ( 3.1 vs 4.8 , p = 0.04 ) , but no significant difference was found after 4 weeks .
-RESULTS	Primary healing was achieved in 33 patients undergoing ligation of the intersphincteric fistula track vs 32 patients undergoing mucosal advancement flap ( p = 0.99 ) .
-RESULTS	Mean healing time was 22.6 days in the ligation of intersphincteric fistula track group vs 32.1 days in mucosal advancement flap group ( p = 0.01 ) .
-RESULTS	After 1 year of follow-up , successful outcome was achieved in 26 patients ( 74.3 % ) undergoing ligation of intersphincteric fistula track and in 20 patients ( 65.7 % ) undergoing mucosal advancement flap ( p = 0.58 ) .
-RESULTS	No significant change in Wexner score occurred 4 weeks postoperatively .
-RESULTS	There was no significant difference between groups regarding Cleveland Global Quality of Life score ( p = 0.5 and 0.07 after 4 and 12 weeks ) .
-CONCLUSIONS	The short-term follow-up is a probable limitation .
-CONCLUSIONS	Although the sample size was calculated to detect difference with 80 % power at a significance level of 5 % , the negative result within this relatively small number of patients might have resulted from type II statistical error .
-CONCLUSIONS	In patients with high transsphincteric anal fistulas , both ligation of intersphincteric fistula track procedure and mucosal advancement flap have a similar long-term healing rate , recurrences , continence , and quality of life .
-CONCLUSIONS	However , ligation of the intersphincteric fistula track has the advantage of less postoperative pain .
-
-###25012418
-BACKGROUND	Executive dysfunction and psychomotor slowing in depressed patients have been associated with poor antidepressant clinical response , but little is known about the value of neurocognitive tests for differential prediction of response .
-METHODS	This report presents new findings for 70 depressed patients tested on neurocogntive tests before receiving treatment with a SSRI ( escitalopram or citalopram ) , NDRI ( bupropion ) or dual mechanism therapy including a serotonergic agent , and for 57 healthy controls .
-RESULTS	As predicted from previous research , patients who did not respond to a SSRI or dual therapy showed poorer word fluency than responders , whereas this was not seen for patients treated with bupropion alone .
-RESULTS	Longer choice reaction time ( RT ) was also found in nonresponders to a SSRI or dual therapy , but the opposite trend was seen for bupropion .
-RESULTS	Using a combined index of word fluency and RT ( with normative performance as a cutoff ) yielded differential predictions of response .
-RESULTS	Equal to or above normal performance predicted good response to a SSRI or dual therapy , with high positive predictive value ( 90 % ) and specificity ( 78 % ) but lower sensitivity ( 53 % ) .
-RESULTS	In contrast , less than normal performance predicted good response to bupropion alone ( positive predictive value = 82 % ; specificity = 67 % ; sensitivity = 90 % ) .
-CONCLUSIONS	Relatively small sample size , no placebo control , and combining across SSRI alone and dual treatments .
-CONCLUSIONS	Although findings are preliminary due to small sample size , brief tests of word fluency and psychomotor speed may help identify depressed patients who are unresponsive to a serotonergic agent , but who may respond to bupropion alone .
-
-###24612073
-BACKGROUND	Electroencephalogram ( EEG ) based depth of anesthesia algorithms developed in the adult population have not demonstrated the same reliability when applied to infants .
-BACKGROUND	This may be due to frequency changes occurring in the EEG during development .
-BACKGROUND	Amplitude-integrated EEG ( aEEG ) is based primarily in the time domain and hence may have greater utility in infants .
-OBJECTIVE	To investigate the relationship between age adjusted Minimal Alveolar Concentration ( MAC ) multiples and aEEG in children under 2 years of age .
-METHODS	The aEEG , Spectral Edge Frequency 90 % ( SEF90 ) and Bispectral Index ( BIS ) were investigated in a prospective study of children < 2 years of age .
-METHODS	After anesthetic induction , and caudal block administration , EEG data were collected simultaneously with BrainZ BRM2 and BIS monitors .
-METHODS	Using a randomized crossover design , children received up to three age adjusted concentrations of sevoflurane : 0.75 , 1 and 1.25 MAC .
-METHODS	After 15 min of stable anesthetic delivery EEG readings were obtained .
-METHODS	Prediction Probability ( Pk ) and correlation coefficients were calculated for each EEG parameter .
-RESULTS	From 51 children 102 stable anesthetics concentrations were obtained .
-RESULTS	For all age groups Pk of aEEG to multiple of age adjusted MAC was < 0.72 indicating a poor predictive power for aEEG .
-RESULTS	In contrast for the SEF90 and BIS there was evidence for better predictive properties in children aged between 6 months and 2 years , with a Pk > 0.81 .
-CONCLUSIONS	The aEEG is unlikely to be a useful measure of anesthesia depth in young children .
-
-###24556982
-OBJECTIVE	To investigate the impact of early skin-to-skin contact ( SSC ) provided for first 24h on incidence of hypothermia in stable newborns weighing 1800g or more during first 48h of life .
-METHODS	Stable newborns ( term and late preterm : Mean gestational age 37.7 ( 1.35 ) weeks , range 34-40 weeks ) having birth weight 1800g or more ( Mean weight 2605.6 ( 419.8 ) grams ) were enrolled after approval from Institutional Human Research Ethics Committee ( CTRI/2013/06 / 003790 ) and randomized into early SSC ( intervention group ) and conventional care ( control group ) .
-METHODS	Initial care in the delivery room for few minutes immediately after birth in both the groups was given under radiant warmer .
-METHODS	In the intervention group , newborns were provided SSC by their mother started between 30min and 1h after birth for first 24h with minimal interruption and were provided conventional care other than SSC for next 24h of life .
-METHODS	In the control group , newborns were kept with their mother and received conventional care other than SSC for first 48h .
-METHODS	Temperature and heart rate of newborns were recorded at 30min , 1 , 2 , 3 , 4 , 5 , 6 , 12 , 24 and at 48h of life in both the groups .
-METHODS	Independent Samples t-Test and relative risk were used to analyze the data .
-RESULTS	Both groups had 50 neonates each with similar baseline characteristics .
-RESULTS	Heart rates were in normal range in both the groups .
-RESULTS	The intervention group provided an average ( s.d. ) of 16.98 ( 0.28 ) h of SSC over the first 24h period .
-RESULTS	The mean temperature was significantly high in the SSC group at all time intervals starting from 1 to 48h ( P < 0.05 for all ) .
-RESULTS	In the SSC group only two newborns ( 4 % ) had mild hypothermia ( cold stress ) , and , of these two newborns , one had two episodes of hypothermia .
-RESULTS	All these three episodes of hypothermia occurred within first 3h of life .
-RESULTS	In the control group 16 newborns ( 32 % ) developed hypothermia ( temperature < 36.5 C ) during first 48h of life .
-RESULTS	Of them , 11 newborns had single episode , 4 newborns had two episodes and one newborn had three episodes of hypothermia .
-RESULTS	Of these 22 hypothermic episodes , 20 occurred in the first 6h of life and 2 episodes occurred at 48h of life .
-RESULTS	Moderate hypothermia was seen in two newborns , whereas rest had mild hypothermia .
-RESULTS	The relative risk of developing hypothermia in the control group as compared with the SSC group was 8.00 ( 95 % CI 1.94-32 .99 ) .
-RESULTS	There was no seasonal variation in incidence of hypothermia in both the groups .
-CONCLUSIONS	Newborns in the SSC group achieved rapid thermal control as compared with the control group .
-CONCLUSIONS	Early SSC for 24h after birth decreases incidence of hypothermia for initial 48h of life .
-CONCLUSIONS	Early SSC needs to be aggressively promoted in term and late-preterm newborns to reduce incidence of hypothermia .
-
-###25341673
-BACKGROUND	Subacromial impingement is a common cause of shoulder complaints in general practice .
-BACKGROUND	When the initial treatment with acetaminophen and low dose Non Steroidal Anti Inflammatory Drugs fails , triamcinolone acetonide injections are commonly used .
-BACKGROUND	Triamcinolone acetonide injections are effective at four to six weeks .
-BACKGROUND	Little is known about the pain relief effect of triamcinolone acetonide injections in the first days after injection and the effect of repeated injection .
-BACKGROUND	In this study we investigate the effect of triamcinolone acetonide injections compared to hyaluronic acid and NaCl injections using a pain diary .
-METHODS	159 Patients recruited for an RCT comparing the effect of subacromial injections of triamcinolone acetonide , hyaluronic acid and sodium chloride ( NaCl ) were used in this study .
-METHODS	They were blinded for their treatment and could receive up to three injections .
-METHODS	Primary outcome consisted of the patient perceived pain on a VAS score recorded on a daily basis during 21 days following injection .
-METHODS	Secondary outcome consisted of the amount of taken escape medication following injection and adverse effects .
-RESULTS	All patients received the first injection .
-RESULTS	150 patients also received the second and third injections .
-RESULTS	97 % Of the paper and pencil pain diaries were returned for data analysis.The triamcinolone acetonide group showed the largest decrease in pain on the VAS scores after injection compared to the hyaluronic acid and NaCl group in the first week after injection .
-RESULTS	The reduction in pain was best achieved after the first injection , the second triamcinolone acetonide injection showed a further reduction in pain .
-RESULTS	The third triamcinolone acetonide injection only showed a slight improvement in pain reduction .
-CONCLUSIONS	In this study we could show a booster effect in pain reduction after repeated triamcinolone acetonide injection .
-CONCLUSIONS	The triamcinolone acetonide group showed a faster reduction in pain after injection compared to the hyaluronic acid and NaCl group .
-CONCLUSIONS	The effect was best seen after the first and second triamcinolone acetonide injection , it is therefore questionable whether it is necessary to repeat triamcinolone acetonide injections more than two times .
-BACKGROUND	ISRCTN51511455 .
-BACKGROUND	Registered 20 December 2005 .
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-###24885124
-BACKGROUND	Managing the oxygen saturation of preterm infants to a target range has been the standard of care for a decade .
-BACKGROUND	Changes in target ranges have been shown to significantly impact mortality and morbidity .
-BACKGROUND	Selecting and implementing the optimal target range are complicated not only by issues of training , but also the realities of staffing levels and demands .
-BACKGROUND	The potential for automatic control is becoming a reality .
-BACKGROUND	Results from the evaluation of different systems have been promising and our own experience encouraging .
-METHODS	This study was conducted in two tertiary level newborn nurseries , routinely using an automated FiO2-SpO2 control system ( Avea-CLiO2 , Yorba Linda CA , USA ) .
-METHODS	The aim of this study was to compare the performance of the system as used routinely ( set control range of 87-93 % SpO2 ) , to a narrower higher range ( 90-93 % ) .
-METHODS	We employed a 12-hour cross-over design with the order of control ranges randomly assigned for each of up to three days .
-METHODS	The primary prospectively identified end points were time in the 87-93 % SpO2 target range , time at SpO2 extremes and the distribution of the SpO2 exposure .
-RESULTS	Twenty-one infants completed the study .
-RESULTS	The infants were born with a median EGA of 27 weeks and studied at a median age of 17 days and weight of 1.08 kg .
-RESULTS	Their median FiO2 was 0.32 ; 8 were intubated , and the rest noninvasively supported ( 7 positive pressure ventilation and 6 CPAP ) .
-RESULTS	The control in both arms was excellent , and required less than 2 manual FiO2 adjustments per day .
-RESULTS	There were no differences in the three primary endpoints .
-RESULTS	The narrower/higher set control range resulted in tighter control ( IQR 3.0 vs. 4.3 p < 0.001 ) , and less time with the SpO2 between 80-86 ( 6.2 % vs. 8.4 % , p = 0.006 ) .
-CONCLUSIONS	We found that a shift in the median of the set control range of an automated FiO2-SpO2 control system had a proportional effect on the median and distribution of SpO2 exposure .
-CONCLUSIONS	We found that a dramatic narrowing of the set control range had a disproportionally smaller impact .
-CONCLUSIONS	Our study points to the potential to optimize SpO2 targeting with an automated control system .
-
-###25090110
-BACKGROUND	Phambili , the Merck ( MRK ) - Adenovirus Type 5 ( Ad5 ) HIV-1 gag/pol/nef subtype B vaccine study , conducted in South Africa , suspended enrollment and vaccination when companion study , Step , was found non-efficacious .
-BACKGROUND	Although the vaccine did not prevent HIV-1 infection or lower viral-load setpoint , immune responses recognized clades B and C HIV-1 subtypes .
-BACKGROUND	We investigated predictors of the vaccine-induced antigen-specific immune responses .
-METHODS	Vaccine-induced immunogenicity was ascertained by interferon - ELISpot assays on the first 186 enrolled participants receiving two vaccinations .
-METHODS	Analyses , stratified by study arm/sex , were performed on baseline demographics [ sex , age , Body Mass Index ( BMI ) , site , Adenovirus Type-5 ( Ad5 ) titer , Herpes Simplex Virus Type-2 ( HSV2 ) status , heavy drinking ] .
-METHODS	Multivariate logistic regression determined predictors .
-RESULTS	Of the 186 participants , 53.7 % ( n = 100 ) were female , median BMI was 22.5 [ IQR : 20.4-27 .0 ] , 85.5 % ( n = 159 ) were Ad5 seropositive , and 18.8 % ( n = 35 ) drank heavily .
-RESULTS	All vaccine recipients responded to both clade B ( n = 87 ; 47 % ) and/or C ( n = 74 ; 40 % ) , p = 0.17 .
-RESULTS	In multivariate analysis , female sex [ Adjusted Odds Ratio ( AOR ) : 6.478 ; p = 0.0159 ] , overweight/obese BMI ( AOR : 0.186 ; p = 0.0452 ) , and heavy drinking ( AOR : 0.270 ; p = 0.048 ) significantly predicted immune response to clade C for any antigens .
-RESULTS	A marginally significant predictor of clade C-pol antigen was female sex ( AOR : 3.182 ; p = 0.0500 ) .
-CONCLUSIONS	Sex , BMI , and heavy drinking affected vaccine-induced HIV-1 specific immune responses to clade C antigens .
-CONCLUSIONS	The role of female sex and overweight/obese BMI boosting and suppressing vaccine-induced HIV-1 specific immune responses , respectively , requires elucidation , including any effect on HIV vaccine efficacy , especially in the era of colliding epidemics ( HIV and obesity ) .
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-###24374724
-OBJECTIVE	This study was designed to test the effects of different types of influence on the expression of stereotypes towards people who are obese .
-OBJECTIVE	It was hypothesized that public social pressure would more significantly impact the expression of stereotypes towards obese people than other types of influence .
-METHODS	One-hundred fifty-eight undergraduate students were randomly assigned to one of three conditions or a control condition .
-METHODS	Participants completed measures of stereotypes towards obese people prior to and after receiving manipulated feedback depicting purported stereotypes possessed by others ( anonymously or publically ) or scientific information about the base rates of these stereotypical traits in the obese population ( i.e. , trait prevalence ) .
-METHODS	Participants also completed a measure of weight bias unrelated to the manipulated feedback .
-RESULTS	Explicit beliefs were influenced more when people perceived that others ' views were inconsistent with their own in a public setting than an anonymous setting or when they received trait prevalence feedback .
-RESULTS	However , levels of weight bias on a separate measure were unchanged .
-CONCLUSIONS	Strong , public manipulations of social feedback have great potential to impact , at least , the short-term expression of stereotypes towards obese people .
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-###26002728
-OBJECTIVE	Ulcerative colitis ( UC ) is a chronic idiopathic inflammatory disease in which reducing pro-inflammatory and/or increasing anti-inflammatory molecules is the mainstay of treatment .
-OBJECTIVE	The aim of this study was to evaluate the effects of supplementation with resveratrol as an antiinflammatory and antioxidant agent on inflammation and quality of life in patients with active UC .
-RESULTS	In this randomized , double-blind , placebo-controlled study , 50 eligible patients with active mild to moderate UC were supplemented with either a 500-mg resveratrol or placebo capsule for 6 weeks .
-RESULTS	Serum inflammatory markers , activity of NF-B in peripheral blood mononuclear cells ( PBMC ) and quality of life were assessed at baseline and at the end of the study .
-RESULTS	Resveratrol supplementation led to a significant reduction in plasma levels of TNF - ( 19.70 12.80 to 17.20 10.09 pg/mL ) and hs-CRP ( 4764.25 2260.48 to 2584.50 1792.80 ng/mL ) and activity of NF-B in PBMCs ( 0.19 0.05 to 0.10 0.04 OD ) ( p < 0.001 ) , whereas there were no significant changes of these factors in placebo group .
-RESULTS	Also , the score of inflammatory bowel disease questionnaire -9 ( IBDQ-9 ) increased , whereas the clinical colitis activity index score decreased significantly in the resveratrol group ( 32.72 7.52 to 47.64 8.59 ) ( p < 0.001 ) and when compared with the placebo group ( 35.54 9.50 to 41.08 6.59 ) ( p < 0.001 ) .
-CONCLUSIONS	Our results indicate that 6 weeks supplementation with 500 mg resveratrol can improve quality of life and disease clinical colitis activity at least partially through inflammation reduction in patients with UC .
-CONCLUSIONS	Whether these effects will be continued in longer duration of treatment remains to be determined .
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-###25706240
-BACKGROUND	Gestational diabetes ( GDM ) confers a high risk of type 2 diabetes .
-BACKGROUND	In the Diabetes Prevention Program ( DPP ) , intensive lifestyle ( ILS ) and metformin prevented or delayed diabetes in women with a history of GDM .
-OBJECTIVE	The objective of the study was to evaluate the impact of ILS and metformin intervention over 10 years in women with and without a history of GDM in the DPP/Diabetes Prevention Program Outcomes Study .
-METHODS	This was a randomized controlled clinical trial with an observational follow-up .
-METHODS	The study was conducted at 27 clinical centers .
-METHODS	Three hundred fifty women with a history of GDM and 1416 women with previous live births but no history of GDM participated in the study .
-METHODS	The participants had an elevated body mass index and fasting glucose and impaired glucose tolerance at study entry .
-METHODS	Interventions included placebo , ILS , or metformin .
-METHODS	Outcomes measure was diabetes mellitus .
-RESULTS	Over 10 years , women with a history of GDM assigned to placebo had a 48 % higher risk of developing diabetes compared with women without a history of GDM .
-RESULTS	In women with a history of GDM , ILS and metformin reduced progression to diabetes compared with placebo by 35 % and 40 % , respectively .
-RESULTS	Among women without a history of GDM , ILS reduced the progression to diabetes by 30 % , and metformin did not reduce the progression to diabetes .
-CONCLUSIONS	Women with a history of GDM are at an increased risk of developing diabetes .
-CONCLUSIONS	In women with a history of GDM in the DPP/Diabetes Prevention Program Outcomes Study , both lifestyle and metformin were highly effective in reducing progression to diabetes during a 10-year follow-up period .
-CONCLUSIONS	Among women without a history of GDM , lifestyle but not metformin reduced progression to diabetes .
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-###24592958
-BACKGROUND	Minority race and lower socioeconomic status are associated with poorer patient ratings of health care quality and provider communication .
-OBJECTIVE	To examine the association of race/ethnicity or socioeconomic status with patients ' and families ' ratings of end-of-life care and communication about end-of-life care provided by physicians-in-training .
-METHODS	As a component of a randomized trial evaluating a program designed to improve clinician communication about end-of-life care , patients and patients ' families completed preintervention survey data regarding care and communication provided by internal medicine residents and medical subspecialty fellows .
-METHODS	We examined associations between patient and family race or socioeconomic status and ratings they gave trainees on two questionnaires : the Quality of End-of-Life Care ( QEOLC ) and Quality of Communication ( QOC ) .
-RESULTS	Patients from racial/ethnic minority groups , patients with lower income , and patients with lower educational attainment gave trainees higher ratings on the end-of-life care subscale of the QOC ( QOCeol ) .
-RESULTS	In path models , patient educational attainment and income had a direct effect on outcomes , while race/ethnicity did not .
-RESULTS	Lower family educational attainment was also associated with higher trainee ratings on the QOCeol , while family non-white race was associated with lower trainee ratings on the QEOLC and general subscale of the QOC .
-CONCLUSIONS	Patient race is associated with perceptions of the quality of communication about end-of-life care provided by physicians-in-training , but the association was opposite to our hypothesis and appears to be mediated by socioeconomic status .
-CONCLUSIONS	Family member predictors of these perceptions differ from those observed for patients .
-CONCLUSIONS	Further investigation of these associations may guide interventions to improve care delivered to patients and families .
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-###25415414
-BACKGROUND	Roller massagers are used as a recovery and rehabilitative tool to initiate muscle relaxation and improve range of motion ( ROM ) and muscular performance .
-BACKGROUND	However , research demonstrating such effects is lacking .
-OBJECTIVE	To determine the effects of applying a roller massager for 20 and 60 seconds on knee-joint ROM and dynamic muscular performance .
-METHODS	Randomized controlled clinical trial .
-METHODS	University laboratory .
-METHODS	Ten recreationally active men ( age = 26.6 5.2 years , height = 175.3 4.3 cm , mass = 84.4 8.8 kg ) .
-METHODS	Participants performed 3 randomized experimental conditions separated by 24 to 48 hours .
-METHODS	In condition 1 ( 5 repetitions of 20 seconds ) and condition 2 ( 5 repetitions of 60 seconds ) , they applied a roller massager to the quadriceps muscles .
-METHODS	Condition 3 served as a control condition in which participants sat quietly .
-METHODS	Visual analog pain scale , electromyography ( EMG ) of the vastus lateralis ( VL ) and biceps femoris during roller massage and lunge , and knee-joint ROM .
-RESULTS	We found no differences in pain between the 20-second and 60-second roller-massager conditions .
-RESULTS	During 60 seconds of roller massage , pain was 13.5 % ( 5.7 0.70 ) and 20.6 % ( 6.2 0.70 ) greater at 40 seconds and 60 seconds , respectively , than at 20 seconds ( P < .05 ) .
-RESULTS	During roller massage , VL and biceps femoris root mean square ( RMS ) EMG was 8 % and 7 % , respectively , of RMS EMG recorded during maximal voluntary isometric contraction .
-RESULTS	Knee-joint ROM was 10 % and 16 % greater in the 20-second and 60-second roller-massager conditions , respectively , than the control condition ( P < .05 ) .
-RESULTS	Finally , average lunge VL RMS EMG decreased as roller-massage time increased ( P < .05 ) .
-CONCLUSIONS	Roller massage was painful and induced muscle activity , but it increased knee-joint ROM and neuromuscular efficiency during a lunge .
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-###25011604
-BACKGROUND	Intensive care units ( ICU ) are epicenters for the emergence of antibiotic-resistant Gram-negative bacteria ( ARGNB ) because of high rates of antibiotic usage , rapid patient turnover , immunological susceptibility of acutely ill patients , and frequent contact between healthcare workers and patients , facilitating cross-transmission .
-BACKGROUND	Antibiotic stewardship programs are considered important to reduce antibiotic resistance , but the effectiveness of strategies such as , for instance , antibiotic rotation , have not been determined rigorously .
-BACKGROUND	Interpretation of available studies on antibiotic rotation is hampered by heterogeneity in implemented strategies and suboptimal study designs .
-BACKGROUND	In this cluster-randomized , crossover trial the effects of two antibiotic rotation strategies , antibiotic mixing and cycling , on the prevalence of ARGNB in ICUs are determined .
-BACKGROUND	Antibiotic mixing aims to create maximum antibiotic heterogeneity , and cycling aims to create maximum antibiotic homogeneity during consecutive periods .
-METHODS	This is an open cluster-randomized crossover study of mixing and cycling of antibiotics in eight ICUs in five European countries .
-METHODS	During cycling ( 9 months ) third - or fourth-generation cephalosporins , piperacillin-tazobactam and carbapenems will be rotated during consecutive 6-week periods as the primary empiric treatment in patients suspected of infection caused by Gram-negative bacteria .
-METHODS	During mixing ( 9 months ) , the same antibiotics will be rotated for each consecutive antibiotic course .
-METHODS	Both intervention periods will be preceded by a baseline period of 4 months .
-METHODS	ICUs will be randomized to consecutively implement either the mixing and then cycling strategy , or vice versa .
-METHODS	The primary outcome is the ICU prevalence of ARGNB , determined through monthly point-prevalence screening of oropharynx and perineum .
-METHODS	Secondary outcomes are rates of acquisition of ARGNB , bacteremia and appropriateness of therapy , length of stay in the ICU and ICU mortality .
-METHODS	Results will be adjusted for intracluster correlation , and patient - and ICU-level variables of case-mix and infection-prevention measures using advanced regression modeling .
-CONCLUSIONS	This trial will determine the effects of antibiotic mixing and cycling on the unit-wide prevalence of ARGNB in ICUs .
-BACKGROUND	ClinicalTrials.gov NCT01293071 December 2010 .
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-###24323568
-BACKGROUND	The current study was performed to evaluate whether baseline acute and chronic prostate inflammation among men with an initial negative biopsy for prostate cancer ( PCa ) increased the risk of subsequent PCa detection in a clinical trial with systematic biopsies .
-METHODS	A retrospective analysis was performed of 6238 men aged 50 years to 75 years with prostate-specific antigen levels between 2.5 ng/mL and 10 ng/mL and a prior negative biopsy in the REduction by DUtasteride of PCa Events study who completed a 2-year biopsy .
-METHODS	PCa , acute prostate inflammation , and chronic prostate inflammation were assessed by central review .
-METHODS	The association between inflammation in baseline prostate biopsies and positive 2-year and 4-year repeat biopsies was evaluated with the chi-square test and logistic regression analysis adjusting for baseline covariates .
-RESULTS	Acute and chronic inflammation and both were detected in 46 baseline biopsies ( 1 % ) , 3931 baseline biopsies ( 63 % ) , and 892 baseline biopsies ( 14 % ) , respectively .
-RESULTS	Acute and chronic inflammation were found to be significantly associated with each other ( P < .001 ) .
-RESULTS	Acute inflammation at baseline biopsy was associated with younger age , lower prostate-specific antigen levels , and a smaller prostate ( all P < .01 ) , whereas chronic inflammation was associated with older age and larger prostate glands ( all P < 0.01 ) .
-RESULTS	At the 2-year biopsy , the prevalence of PCa was 14 % ( N = 900 patients ) .
-RESULTS	On univariable and multivariable analysis , both acute and chronic inflammation were found to be significantly associated with a lower PCa risk ( acute univariable : odds ratio [ OR ] , 0.65 [ P < .001 ] and multivariable : OR , 0.75 [ P = .012 ] and chronic univariable : OR , 0.61 [ P < .001 ] and multivariable : OR , 0.65 [ P < .001 ] ) .
-RESULTS	At the time of 4-year biopsy , only acute inflammation was found to be associated with a lower PCa risk .
-CONCLUSIONS	Baseline acute and chronic inflammation were both found to be independently associated with a lower PCa risk .
-CONCLUSIONS	From a clinical standpoint , inflammation in negative biopsies for PCa may lower the risk of subsequent PCa detection .
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-###26441182
-OBJECTIVE	The benefits of rehabilitation after immobilization for ankle fracture are unclear .
-OBJECTIVE	To determine the effectiveness of a supervised exercise program and advice ( rehabilitation ) compared with advice alone and to determine if effects are moderated by fracture severity or age and sex .
-METHODS	The EXACT trial was a pragmatic , randomized clinical trial conducted from December 2010 to June 2014 .
-METHODS	Patients with isolated ankle fracture presenting to fracture clinics in 7 Australian hospitals were randomized on the day of removal of immobilization .
-METHODS	Of 571 eligible patients , 357 chose not to participate and 214 were allocated to rehabilitation ( n = 106 ) or advice alone ( n = 108 ) , with 194 ( 91 % ) followed up at 1 month , 173 ( 81 % ) at 3 months , and 170 ( 79 % ) at 6 months .
-METHODS	There were no withdrawals attributed to adverse effects .
-METHODS	Recruitment terminated early on December 31 , 2013 ( planned enrollment , 342 ; actual , 214 ) , because funding was exhausted .
-METHODS	Supervised exercise program and advice about self-management ( rehabilitation ) ( individually tailored , prescribed , monitored , and progressed ) or advice alone , both delivered by a physical therapist .
-METHODS	Primary outcomes were activity limitation assessed using the Lower Extremity Functional Scale ( score range , 0-80 ; higher scores indicate better activity ) , and quality of life assessed using the Assessment of Quality of Life ( score range , 0-1 ; higher scores indicate better quality of life ) , measured at baseline and at 1 , 3 ( primary time point ) , and 6 months .
-RESULTS	Mean activity limitation and quality of life at baseline were 30.1 ( SD , 12.5 ) and 0.51 ( SD , 0.24 ) , respectively , for advice and 30.2 ( SD , 13.2 ) and 0.54 ( SD , 0.24 ) for rehabilitation , increasing to 64.3 ( SD , 13.5 ) and 0.85 ( SD , 0.17 ) for advice vs 64.3 ( SD , 15.1 ) and 0.85 ( SD , 0.20 ) for rehabilitation at 3 months .
-RESULTS	Rehabilitation was not more effective than advice for activity limitation ( mean effect at 3 months , 0.4 [ 95 % CI , -3.3 to 4.1 ] ) or quality of life ( -0.01 [ 95 % CI , -0.06 to 0.04 ] ) .
-RESULTS	Treatment effects were not moderated by fracture severity or age and sex .
-CONCLUSIONS	A supervised exercise program and advice did not confer additional benefits in activity limitation or quality of life compared with advice alone for patients with isolated and uncomplicated ankle fracture .
-CONCLUSIONS	These findings do not support the routine use of supervised exercise programs after removal of immobilization for patients with isolated and uncomplicated ankle fracture .
-BACKGROUND	anzctr.org.au Identifier : ACTRN12610000979055 .
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-###25769319
-OBJECTIVE	To investigate the efficacy and safety of Ji-Tai tablet and Ji-Tai tablet combined with buprenorphine in the treatment of patients with acute withdrawal syndrome of mild heroin dependence .
-METHODS	A total of 150 patients with mild heroin dependence were recruited , and were randomly assigned to a Ji-Tai tablet group ( n = 50 ) , a Ji-Tai tablet combined with buprenorphine group ( n = 50 ) and a control group ( n = 50 ) during a 10-day clinical trial .
-METHODS	Opiate withdrawal scale ( OWS ) was used to measure the severity of withdrawal symptoms .
-METHODS	Anxiety symptoms assessments were made at 0 day ( baseline ) , the day 5 ( middle ) , and the day 10 ( end ) by the Hamilton anxiety scale ( HAMA ) .
-METHODS	Symptoms were assessed before and 1 h or 2 h after medication each day .
-METHODS	The total withdrawal symptoms scores and the daily reduction rate were used to measure the effect of Ji-Tai tablet vs Ji - Tai tablet plus buprenorphine .
-METHODS	Safety evaluation was carried out by the following measures : baseline of treatment , drug side effects after the treatment , vital signs ( blood pressure , heart rate , and respiration rate ) , laboratory examination ( routine blood and urine tests and the liver and kidney function tests ) , and electrocardiograms .
-RESULTS	A total of 142 mild heroin dependence patients performed the experiments ( including 48 in the Ji-Tai tablet group , 48 in the Ji-Tai tablet with buprenorphine group and 46 in the control group ) .
-RESULTS	The scores of baseline withdrawal symptoms were 43.52019.786 , 42.64017.648 and 47.10024.450 , respectively , with no significant differences among the 3 groups ( all P > 0.05 ) .
-RESULTS	During the 10-day treatment , the reduction rate of acute withdrawal symptoms scores increased daily , the acute withdrawal syndrome scores and the anxiety symptoms scores declined from day 0 to day 10 , there was also no significant difference among the 3 groups ( all P > 0.05 ) .
-RESULTS	Ji-Tai tablet did not affect vital signs such as blood pressure , heart rate , and respiration rate .
-CONCLUSIONS	Ji-Tai tablet or Ji-Tai tablet combined with buprenorphine had no effect on acute withdrawal symptoms of mild heroin dependence .
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-###25662592
-BACKGROUND	Human infection with the avian influenza A H5N1 virus results in disease with a high fatality rate , against which antiviral treatments have limited efficacy .
-BACKGROUND	We aimed to investigate the safety , pharmacokinetics , and therapeutic potential of specific polyclonal immunoglobulin equine F ( ab ' ) fragments raised against influenza A/Vietnam/1194 / 2004 virus ( H5N1 subtype ) in healthy volunteers .
-METHODS	We did a randomised , double-blind , placebo-controlled , single-centre phase 1 study .
-METHODS	In stage 1 ( one infusion ) and stage 2 ( five infusions ) of the trial , we randomly assigned healthy male volunteers to receive once-daily intravenous infusions of 085 U/kg body weight of F ( ab ' ) or once-daily saline placebo .
-METHODS	Randomisation was done centrally , with one block of four patients and one block for substitutes ( three actives , one placebo ) in stage 1 , and two blocks of six patients ( five actives and one placebo ) and the same block for substitutes in stage 2 .
-METHODS	The primary objective was assessment of the clinical and laboratory safety of F ( ab ' ) , which was monitored for 22 days in the group that received one dose ( assessments on days 0-2 , 4 , 8 , 15 , and 22 ) and 33 days in the group that received five doses ( days 0-6 , 8 , 10 , 12 , 19 , 26 , and 33 ) .
-METHODS	A final post-study safety assessment was done at 120 days .
-METHODS	We also assessed pharmacokinetic outcomes , and assayed haemagglutination and seroneutralisation activity .
-METHODS	Analysis was done according to intention-to-treat .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT02295813 .
-RESULTS	We enrolled 16 healthy Asian men between Sept 28 and Dec 28 , 2012 , and randomly assigned 13 to one or five doses of F ( ab ' ) and three to placebo .
-RESULTS	F ( ab ' ) was well tolerated , and no deaths or serious adverse events occurred .
-RESULTS	Three patients had mild adverse events ( one each of blepharospasm , sinusitis , and pyrexia ) .
-RESULTS	The pyrexia ( 38C ) was regarded as probably related to the infusion , and resolved after 37 min .
-RESULTS	Our laboratory assessments of blood and urine samples and physical examinations of heart rate , electrocardiogram readings , and weight showed no clinically significant safety issues .
-RESULTS	Mean peak plasma concentrations were 193 g/mL ( SD 35 ) with the one dose schedule and 230 g/mL ( 45 ) with the five-dose schedule .
-RESULTS	F ( ab ' ) were still detectable in plasma on average up to 5 days after five doses .
-RESULTS	Haemagglutination inhibition was only increased after the third dose , but in-vitro seroneutralisation activity was transiently increased after each of the five doses to concentrations regarded as clinically beneficial in infected patients .
-CONCLUSIONS	F ( ab ' ) showed good safety , tolerability , and therapeutic potential for managing of H5N1 exposed patients .
-BACKGROUND	Fab ` entech .
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-###25116085
-OBJECTIVE	Declining inspiratory muscle function and structure and systemic low-level inflammation and oxidative stress may contribute to morbidity and mortality during normal ageing .
-OBJECTIVE	Therefore , we examined the effects of inspiratory muscle training ( IMT ) in older adults on inspiratory muscle function and structure and systemic inflammation and oxidative stress , and reexamined the reported positive effects of IMT on respiratory muscle strength , inspiratory muscle endurance , spirometry , exercise performance , physical activity levels ( PAL ) , and quality of life ( QoL ) .
-METHODS	Thirty-four healthy older adults ( 68 3 yr ) with normal spirometry , respiratory muscle strength , and physical fitness were divided equally into a pressure-threshold IMT or sham-hypoxic placebo group .
-METHODS	Before and after an 8-wk intervention , measurements were taken for dynamic inspiratory muscle function and inspiratory muscle endurance using a weighted plunger pressure-threshold loading device ; diaphragm thickness by using B-mode ultrasonography ; plasma cytokine concentrations by using immunoassays ; DNA damage levels in peripheral blood mononuclear cells by using comet assays ; spirometry , maximal mouth pressures , and exercise performance by using a 6-min walk test ; PAL by using a questionnaire and accelerometry ; and QoL using a questionnaire .
-RESULTS	Compared with placebo , IMT increased maximal inspiratory pressure ( +34 % 43 % , P = 0.008 ) , diaphragm thickness at residual volume ( +38 % 39 % , P = 0.03 ) , and peak inspiratory flow ( +35 % 42 % , P = 0.049 ) but did not change other spirometry measures , plasma cytokine concentrations , DNA damage levels in peripheral blood mononuclear cells , dynamic inspiratory muscle function , inspiratory muscle endurance , exercise performance , PAL , or QoL .
-CONCLUSIONS	These novel data indicate that in healthy older adults , IMT elicits some positive changes in inspiratory muscle function and structure but neither attenuates systemic inflammation and oxidative stress nor improves exercise performance , PAL , or QoL .
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-###25170262
-BACKGROUND	To be an older woman , live alone , have chronic pain , and be dependent on support are all factors that may have an impact on daily life .
-BACKGROUND	One way to promote ability in everyday activities in people with pain-related conditions is to use individualized , integrated behavioral medicine in physical therapy interventions .
-BACKGROUND	How this kind of intervention works for older women living alone at home , with chronic pain , and dependent on formal care to manage their everyday lives has not been studied .
-BACKGROUND	The aim was to explore the feasibility of a study and to evaluate an individually tailored integrated behavioral medicine in physical therapy intervention for the target group of women .
-METHODS	The study was a 12-week randomized trial with two-group design .
-METHODS	Primary effect outcomes were pain-related disability and morale .
-METHODS	Secondary effect outcomes focused on pain-related beliefs , self-efficacy for exercise , concerns of falling , physical activity , and physical performance .
-RESULTS	In total , 23 women agreed to participate in the study and 16 women completed the intervention .
-RESULTS	The results showed that the behavioral medicine in physical therapy intervention was feasible .
-RESULTS	No effects were seen on the primary effect outcomes .
-RESULTS	The experimental intervention seemed to improve the level of physical activity and self-efficacy for exercise .
-RESULTS	Some of the participants in both groups perceived that they could manage their everyday life in a better way after participation in the study .
-CONCLUSIONS	Results from this study are encouraging , but the study procedure and interventions have to be refined and tested in a larger feasibility study to be able to evaluate the effects of these kinds of interventions on pain-related disability , pain-related beliefs , self-efficacy in everyday activities , and morale in the target group .
-CONCLUSIONS	Further research is also needed to refine and evaluate effects from individualized reminder routines , support to collect self-report data , safety procedures for balance training , and training of personnel to enhance self-efficacy .
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-###25336921
-OBJECTIVE	Although cilnidipine and valsartan are widely coadministered to patients with hypertension , their drug-drug interaction potential has not been investigated .
-OBJECTIVE	This study compared the pharmacokinetic ( PK ) , pharmacodynamic ( PD ) , and tolerability profiles of cilnidipine and valsartan , both alone and in combination , in healthy male subjects .
-METHODS	Fifty-four subjects , enrolled into an open-label , single-dose , three-treatment , three-period crossover study , randomly received cilnidipine ( 10 mg ) , valsartan ( 160 mg ) , or both according to one of six sequences .
-METHODS	Blood samples were collected at baseline and up to 24 hours after drug administration in each period .
-METHODS	Plasma concentrations of cilnidipine and valsartan were determined by liquid chromatography with tandem mass spectrometry .
-METHODS	Maximum plasma concentration ( Cmax ) and area under the concentration-time curve from 0 to the last measurable time ( AUC ( last ) ) were estimated using a noncompartmental method .
-METHODS	Tolerability was evaluated by assessing adverse events ( AEs ) , vital signs , electrocardiograms , and clinical laboratory tests .
-METHODS	Blood pressure was also measured for PD assessment .
-RESULTS	A total of 51 subjects completed the study .
-RESULTS	The PK profile of cilnidipine was not significantly affected by coadministered valsartan ; the geometric mean ratio and 90 % confidence interval ( 90 % CI ) of AUC ( last ) for cilnidipine with and without valsartan was 1.04 ( 0.98-1 .10 ) .
-RESULTS	Likewise , cilnidipine did not affect the PK of valsartan ; the geometric mean ratio ( 90 % CI ) of AUC ( last ) for valsartan with and without cilnidipine was 0.94 ( 0.83-1 .07 ) .
-RESULTS	Coadministration of cilnidipine and valsartan reduced blood pressure in an additive way .
-RESULTS	No serious AEs were reported , and both cilnidipine and valsartan were well tolerated .
-CONCLUSIONS	Coadministered cilnidipine and valsartan do not cause a significant PK or PD interaction , and they are well tolerated .
-
-###24831204
-OBJECTIVE	Little is known about the necessity of multiple same-day intraocular pressure ( IOP ) measurements in describing the effect of IOP-lowering surgical procedures , and such evidence could affect surgical trial recruitment and retention of participants .
-OBJECTIVE	To determine whether a single IOP measurement might adequately approximate the mean of several measurements in glaucoma surgical trials .
-METHODS	A prospective , multicenter , interventional cohort from the prerandomization phase of a randomized clinical trial evaluating use of a supraciliary implant for treatment of IOP was conducted at multiple ophthalmology clinics .
-METHODS	A total of 609 patients ( 609 eyes ) with primary open-angle glaucoma and cataract were included .
-METHODS	One IOP measurement was made while patients were receiving their usual medications to lower IOP , and 3 IOP measurements were made at 8 am , 12 pm , and 4 pm after patients underwent washout of all IOP-lowering eyedrops .
-METHODS	The proportion of eyes in which the increase in IOP after washout , using the mean of the 3 measurements , differed by more than 0.5 , 1.0 , 1.5 , or 2.0 mm Hg from the increase in IOP after washout using only 1 of the postwashout measurements .
-METHODS	A proportion of 10 % or less at the 1.5-mm Hg cutoff was considered clinically acceptable .
-METHODS	The hypothesis was formulated after data collection but before the data were examined .
-RESULTS	The mean ( SD ) IOP before washout was 18.5 ( 4.0 ) mm Hg .
-RESULTS	The mean increase in IOP after washout , using the mean of the 3 measurements , was 5.3 ( 4.2 ) mm Hg .
-RESULTS	The percentage of eyes in which the increase in IOP using a single postwashout IOP differed from the increase in IOP using the mean of 3 measurements by more than 1.5 mm Hg was 35.1 % , 25.6 % , 34.2 % , 30.0 % , and 31.4 % when the single measurement was made at 8 am , 12 pm , 4 pm , a randomly chosen single measure of those 3 times , and the time closest to that of the prewashout IOP , respectively .
-RESULTS	By logistic regression , the 12 pm postwashout IOP had the lowest proportion of eyes differing from the mean ( P < .001 ) and thus most closely approximated the mean diurnal IOP .
-CONCLUSIONS	Although eliminating multiple IOP measurements would simplify the conduct of surgical trials in glaucoma , our data show that using a single IOP measurement after washout does not adequately approximate the mean of multiple IOP measurements .
-
-###25920633
-OBJECTIVE	To evaluate the clinical and ultrasonographic changes in the morphology and vascularity of the common extensor tendon after injecting platelet-rich plasma ( PRP ) or corticosteroid ( CS ) for recalcitrant lateral epicondylitis ( LE ) .
-METHODS	30 patients aged 18 to 60 years with recalcitrant ( > 6 months ) LE not responsive to oral medication or non-invasive treatment were randomised to receive PRP ( n = 15 ) or CS ( n = 15 ) injection .
-METHODS	Patients were assessed using the visual analogue scale ( VAS ) for pain , Disabilities of the Arm , Shoulder and Hand Scale ( DASH ) score , Oxford Elbow Score , modified Mayo Clinic performance index for the elbow ( modified Mayo score ) , and hand grip strength .
-METHODS	Ultrasonography was performed by a musculoskeletal ultrasonologist to evaluate for tear at the common extensor origin , oedema at the common extensor origin , cortical erosion , probe-induced tenderness , and thickness of the tendon .
-RESULTS	The VAS for pain , DASH score , Oxford Elbow Score , modified Mayo score , and hand grip strength all improved significantly from pre-injection to the 6-month follow-up in the PRP and CS groups .
-RESULTS	However , in the CS group , the scores generally peaked at 3 months and then deteriorated slightly at 6 months indicating recurrence of symptoms , which involved 46.7 % of the CS patients .
-RESULTS	At 6 months , the number of patients positive for various ulrasonographic findings generally decreased .
-RESULTS	However , in the CS group , the number of patients with reduced thickness of the common extensor tendon increased from 2 to 12 , and the number of patients with cortical erosion at the lateral epicondyle increased from 9 to 11 .
-CONCLUSIONS	PRP appeared to enable biological healing of the lesion , whereas CS appeared to provide short-term , symptomatic relief but resulted in tendon degeneration .
-
-###24423431
-OBJECTIVE	To assess vitamin D status of pediatric patients with Crohn 's disease ( CD ) and to compare their serum 25-hydroxyvitamin D ( s-25OHD ) with established cutoffs and assess whether 6 months of supplementation with 2000 IU/d , vs 400 IU/d , would reduce the group prevalence of vitamin D below these cutoffs .
-METHODS	Subjects 8-18 years ( n = 83 ) with quiescent CD were randomized to either 400 or 2000 IU vitamin D3/d for 6 months .
-RESULTS	Baseline mean SD s-25OHD was 24 8 ng/mL ; 13 subjects ( 16 % ) had an s-25OHD < 16 ng/mL , 27 ( 33 % ) < 20 ng/mL , and 65 ( 79 % ) < 30 ng/mL .
-RESULTS	There was no significant difference between groups in achieving the cutoffs of 16 ng/mL or 20 ng/mL at 6 months ; however , only 35 % of the 400 IU group achieved the greater cutoff of 30 ng/mL compared with 74 % in the 2000 IU group ( P < .001 ) .
-RESULTS	Baseline adjusted mean s-25OHD concentrations at 6 months were 9.6 ng/mL ( 95 % CI 6.0-13 .2 , P < .001 ) greater in the 2000 IU than the 400 IU group .
-RESULTS	Disease activity was not affected by supplement dose .
-RESULTS	Few subjects exceeded safety marker cutoffs , and this did not differ by dose .
-CONCLUSIONS	At baseline , a high proportion of patients had a mean s-25OHD > 20 ng/mL .
-CONCLUSIONS	2000 IU vitamin D3/d is more effective in raising s-25OHD concentrations to > 30 ng/mL in children with CD than 400 IU/d , but both treatments were equally effective at achieving 16 or 20 ng/mL .
-
-###25847559
-OBJECTIVE	Cerebral injury caused by hypoperfusion during the perioperative period is one of the main causes of disability and death in patients after major surgery .
-OBJECTIVE	No effective protective or preventative strategies have been identified .
-OBJECTIVE	This study was designed to evaluate the effects of Ginkgo biloba extract on cerebral oxygen and glucose metabolism in elderly patients with known , pre-existing cerebral ischemia .
-METHODS	Sixty ASA ( American Society of Anesthesiologists ) II-III patients , diagnosed with vertebral artery ischemia by transcranial Doppler ultrasonography ( TCD ) , and scheduled for elective total hip replacement surgery , were enrolled in the study .
-METHODS	They were randomly allocated to receive either 1mg/kg Ginkgo biloba extract ( G group n = 30 ) or normal saline ( D group n = 30 ) after induction of anesthesia .
-METHODS	Blood samples were collected from radial artery and jugular venous bulb catheters for blood gas analysis and determination of glucose and lactate concentrations preoperatively , before surgical incision , at the end of surgery , and on post-op day 1 .
-METHODS	Arterial O2 content ( CaO2 ) , jugular venous O2 content ( CjvO2 ) , arteriovenous O2 content difference ( Da-jvO2 ) , cerebral oxygen extraction rate ( CEO2 ) , and arteriovenous glucose and lactate content differences ( Da-jvGlu and Da-jvLac ) were calculated .
-RESULTS	There were no significant differences in CaO2 or Da-jvGlu during surgery between groups ( p > 0.05 ) .
-RESULTS	However , the Ginkgo group had higher CjvO2 , internal jugular venous oxygen saturation ( SjvO2 ) and lower CEO2 , Da-jvO2 and Da-jvLac at the end of surgery ( T2 ) and on post-op day 1 ( T3 ) than those in the control group ( p < 0.05 ) .
-CONCLUSIONS	Ginkgo biloba extract can improve cerebral oxygen supply , decrease cerebral oxygen extraction rate and consumption , and help maintain the balance between cerebral oxygen supply and consumption .
-CONCLUSIONS	It has no effect , however , on cerebral glucose metabolism in elderly patients with known , pre-existing cerebral ischemia .
-
-###24368027
-BACKGROUND	Myocardial deformation analysis by speckle-tracking echocardiography ( STE ) has been shown to accurately predict viability in patients with chronic ischemic left ventricular ( LV ) dysfunction .
-BACKGROUND	The aim of this study was to evaluate two-dimensional STE for the prediction of global and segmental LV functional changes after acute myocardial infarction ( AMI ) in comparison with late gadolinium enhancement ( LGE ) cardiac magnetic resonance ( CMR ) .
-METHODS	In 93 patients ( mean age , 60 11 years ) with first AMIs ( 55 with ST-segment elevation myocardial infarctions and 38 with non-ST-segment elevation myocardial infarctions ) treated with acute percutaneous coronary intervention , global peak longitudinal strain was determined to describe global function by STE , and peak systolic circumferential and longitudinal strain was determined for segmental function analysis .
-METHODS	LGE CMR was performed to define the amounts of global and segmental myocardial scar .
-METHODS	STE and LGE CMR were performed within 48 hours of AMI .
-METHODS	At 6-month follow-up , transthoracic echocardiography was repeated to determine global und segmental LV recovery and adverse LV remodeling ( increase in end-systolic volume > 15 % ) .
-RESULTS	Accuracy to predict global functional improvement as well as LV remodeling at 6-month follow-up after AMI was similar for STE and LGE CMR ( areas under the curve , 0.715 vs 0.729 [ P = .8830 ] and 0.806 vs 0.824 [ P = .7141 ] , respectively ) .
-RESULTS	Peak systolic circumferential strain < -14.2 % had sensitivity of 71.6 % and specificity of 58.1 % to predict segmental functional improvement .
-RESULTS	Compared with LGE CMR , the predictive accuracy of transmural STE for segmental functional improvement at 6-month follow-up was lower ( area under the curve , 0.788 vs 0.668 ; P = .0001 ) .
-RESULTS	Predictive accuracy for segmental functional improvement could be improved by analysis of endocardial circumferential strain ( area under the curve , 0.700 vs 0.668 for transmural speckle-tracking echocardiographic analysis ; P = .0023 ) .
-CONCLUSIONS	Two-dimensional STE allows the prediction of global functional recovery as well as LV remodeling after AMI with accuracy comparable with that of LGE CMR .
-CONCLUSIONS	Accuracy to predict segmental functional recovery using transmural deformation analysis by two-dimensional STE is inferior compared with LGE CMR but can be improved by a layer-specific analysis of endocardial deformation .
-
-###24500147
-BACKGROUND	Studies indicate an effect of dietary calcium on change in body weight ( BW ) and waist circumference ( WC ) , but the results are inconsistent .
-BACKGROUND	Furthermore , a relation could depend on genetic predisposition to obesity .
-OBJECTIVE	The objective was to examine whether genetic predisposition to higher body mass index ( BMI ) , WC , or waist-hip ratio ( WHR ) interacts with dietary calcium in relation to subsequent annual change in BW ( BW ) and WC ( WC ) .
-METHODS	The study was based on 7569 individuals from the MONItoring trends and determinants of CArdiovascular disease Study , a sample from the Danish Diet , Cancer and Health Study and the INTER99 study , with information on diet ; 54 single-nucleotide polymorphisms ( SNPs ) associated with BMI , WC , or WHR adjusted for BMI ; and potential confounders .
-METHODS	The SNPs were combined in 4 scores as indicators of genetic predisposition ; all SNPs in a general score and a score for each of 3 phenotypes : BMI , WC , and WHR .
-METHODS	Linear regression was used to examine the association between calcium intake and BW or WC adjusted for concurrent BW .
-METHODS	SNP score calcium interactions were examined by adding product terms to the models .
-RESULTS	We found a significant BW of -0.076 kg ( P = 0.021 ; 95 % CI : -0.140 , -0.012 ) per 1000 mg Ca .
-RESULTS	No significant association was observed between dietary calcium and WC .
-RESULTS	In the analyses with BW as outcome , we found no significant interactions between the developed predisposition scores and calcium .
-RESULTS	However , we found a significant interaction between a score of 6 WC-associated SNPs and calcium in relation to WC .
-RESULTS	Each risk allele was associated with a WC of -0.043 cm ( P = 0.038 ; 95 % CI : -0.083 , -0.002 ) per 1000 mg Ca .
-CONCLUSIONS	Our study suggests that dietary calcium relates weakly to BW loss .
-CONCLUSIONS	We found no evidence of a general association between calcium and WC , but calcium may reduce WC among people genetically predisposed to a high WC .
-CONCLUSIONS	However , further replication of this finding is needed .
-
-###24719126
-OBJECTIVE	We aimed to investigate whether combination therapy using intracoronary ( IC ) abciximab and aspiration thrombectomy ( AT ) enhances myocardial perfusion compared to each treatment alone in patients with ST-elevation myocardial infarction ( STEMI ) undergoing primary percutaneous coronary intervention ( PCI ) .
-METHODS	We enrolled 40 patients with STEMI , who presented within 6 h of symptom onset and had Thrombolysis in MI flow 0/1 or a large angiographic thrombus burden ( grade 3/4 ) .
-METHODS	Patients were randomly divided into 3 groups : 10 patients who received a bolus of IC abciximab ( 0.25 mg/kg ) ; 10 patients who received only AT ; and 20 patients who received both treatments .
-METHODS	The index of microcirculatory resistance ( IMR ) was measured with a pressure sensor/thermistor-tipped guidewire following successful PCI .
-METHODS	Microvascular obstruction ( MVO ) was assessed using cardiac magnetic resonance imaging on day 5 .
-RESULTS	IMR was lower in the combination group than in the IC abciximab group ( 23.57.4 U vs. 66.948.7 U , p = 0.001 ) and tended to be lower than in the AT group , with barely missed significance ( 23.57.4 U vs. 37.226.1 U , p = 0.07 ) .
-RESULTS	MVO was observed less frequently in the combination group than in the IC abciximab group ( 18.8 % vs. 88.9 % , p = 0.002 ) and tended to occur less frequently than in the AT group ( 18.8 % vs. 66.7 % , p = 0.054 ) .
-RESULTS	No difference of IMR and MVO was found between the IC abciximab and the AT group ( 66.948.7 U vs. 37.226.1 U , p = 0.451 for IMR ; 88.9 % vs. 66.7 % , p = 0.525 for MVO , respectively ) .
-CONCLUSIONS	Combination treatment using IC abciximab and AT may synergistically improve myocardial perfusion in patients with STEMI undergoing primary PCI ( Trial Registration : clinicaltrials .
-CONCLUSIONS	gov Identifier : NCT01404507 ) .
-
-###24568365
-BACKGROUND	Polyetheretherketone ( PEEK ) cages have been widely used in the treatment of lumbar degenerative disc disorders , and show good clinical results .
-BACKGROUND	Still , complications such as subsidence and migration of the cage are frequently seen .
-BACKGROUND	A lack of osteointegration and fibrous tissues surrounding PEEK cages are held responsible .
-BACKGROUND	Ceramic implants made of silicon nitride show better biocompatible and osteoconductive qualities , and therefore are expected to lower complication rates and allow for better fusion.Purpose of this study is to show that fusion with the silicon nitride cage produces non-inferior results in outcome of the Roland Morris Disability Questionnaire at all follow-up time points as compared to the same procedure with PEEK cages .
-METHODS	This study is designed as a double blind multi-center randomized controlled trial with repeated measures analysis .
-METHODS	100 patients ( 18-75 years ) presenting with symptomatic lumbar degenerative disorders unresponsive to at least 6 months of conservative treatment are included .
-METHODS	Patients will be randomly assigned to a PEEK cage or a silicon nitride cage , and will undergo a transforaminal lumbar interbody fusion with pedicle screw fixation .
-METHODS	Primary outcome measure is the functional improvement measured by the Roland Morris Disability Questionnaire .
-METHODS	Secondary outcome parameters are the VAS leg , VAS back , SF-36 , Likert scale , neurological outcome and radiographic assessment of fusion .
-METHODS	After 1 year the fusion rate will be measured by radiograms and CT. .
-METHODS	Follow-up will be continued for 2 years .
-METHODS	Patients and clinical observers who will perform the follow-up visits will be blinded for type of cage used during follow-up .
-METHODS	Analyses of radiograms and CT will be performed independently by two experienced radiologists .
-CONCLUSIONS	In this study a PEEK cage will be compared with a silicon nitride cage in the treatment of symptomatic degenerative lumbar disc disorders .
-CONCLUSIONS	To our knowledge , this is the first randomized controlled trial in which the silicon nitride cage is compared with the PEEK cage in patients with symptomatic degenerative lumbar disc disorders .
-BACKGROUND	NCT01557829 .
-
-###24703167
-BACKGROUND	Yoga is a popular mind-body therapy that has demonstrated beneficial effects on psychological , behavioral , and functional outcomes .
-BACKGROUND	However , few studies have investigated effects on inflammatory processes .
-BACKGROUND	This study tested the hypothesis that an Iyengar yoga intervention specifically designed for fatigued breast cancer survivors would lead to decreases in inflammation-related gene expression and circulating markers of proinflammatory cytokine activity .
-METHODS	Breast cancer survivors with persistent cancer-related fatigue were randomized to a 12-week Iyengar yoga intervention ( n = 16 ) or a 12-week health education control condition ( n = 15 ) .
-METHODS	Blood samples were collected at baseline , post-intervention , and at a 3-month follow-up for genome-wide transcriptional profiling and bioinformatic analyses .
-METHODS	Plasma inflammatory markers and salivary cortisol were also assessed .
-RESULTS	In promoter-based bioinformatics analyses , the yoga group showed reduced activity of the pro-inflammatory transcription factor nuclear factor kappa B ( NF-B ) , increased activity of the anti-inflammatory glucocorticoid receptor , and reduced activity of cAMP response element-binding protein ( CREB ) family transcription factors relative to controls ( all ps < .05 ) .
-RESULTS	There was also a significant intervention effect on the soluble tumor necrosis factor receptor type II ( sTNF-RII ) , a marker of TNF activity ; plasma levels of sTNF-RII remained stable in the yoga group , whereas levels of this marker increased in the health education group ( p = .028 ) .
-RESULTS	A similar , non-significant trend was observed for the interleukin 1 receptor antagonist ( p = .16 ) .
-RESULTS	No significant changes in C reactive protein ( CRP ) , interleukin 6 ( IL-6 ) , or diurnal cortisol measures were observed .
-CONCLUSIONS	A 12-week restorative Iyengar yoga intervention reduced inflammation-related gene expression in breast cancer survivors with persistent fatigue .
-CONCLUSIONS	These findings suggest that a targeted yoga program may have beneficial effects on inflammatory activity in this patient population , with potential relevance for behavioral and physical health .
-
-###24786979
-BACKGROUND	High left ventricular ( LV ) pacing threshold ( PT ) may in some cases indicate the presence of scarred myocardium , a predictor of poor outcome in cardiac resynchronization therapy ( CRT ) treated patients .
-BACKGROUND	We hypothesized that intraoperative LVPT can be used to determine echocardiographic and clinical responses to CRT .
-RESULTS	The study comprised 975 patients enrolled in the CRT-D arm of the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy ( MADIT-CRT ) .
-RESULTS	Multivariate regression analysis was performed to evaluate the relationship between LVPT and percent reduction in LV end-systolic volume ( ESV ) and left atrial volume ( LAV ) 1 year after CRT .
-RESULTS	Cox proportional hazards analysis was used to evaluate the relationship between LVPT and heart failure ( HF ) events or death ( primary endpoint ) and all-cause death ( secondary endpoint ) .
-RESULTS	An increasing LVPT was inversely related to percent reduction in both LVESV ( P = 0.02 ) and LAV ( P < 0.01 ) .
-RESULTS	Patients with LVPT in the highest quartile ( > 1.8 V ) were less likely to achieve reverse LV remodeling ( 15 % LVESV reduction from baseline ) than those with LVPT in the lower quartiles ( hazard ratios [ HR ] OR 0.56 , P = 0.02 ) .
-RESULTS	Mean percent reduction in LAV and LVESV was also significantly greater among those with lowest quartile LVPT .
-RESULTS	Multivariate analysis showed borderline significant 13 % ( P = 0.06 ) and significant 22 % ( P = 0.03 ) increase in the risk of HF/death and death alone , respectively , per 1 volt increase in LVPT .
-CONCLUSIONS	High intraoperative LVPT is associated with significantly lower echocardiographic and clinical response to CRT-D .
-
-###24515256
-OBJECTIVE	Insulin resistance plays a central role in the pathophysiology of metabolic syndrome ( MS ) .
-OBJECTIVE	Its cardiac deleterious effects are characterized by an increase in fibrous tissue that increases myocardial stiffness and contributes to subclinical left ventricular diastolic dysfunction ( LVDD ) and heart failure with preserved ejection fraction in patients with MS. In addition to lifestyle counseling ( LC ) , metformin treatment may attenuate or even reverse diastolic dysfunction in these patients .
-OBJECTIVE	This trial aims to evaluate if treating non-diabetic patients with MS and LVDD with metformin in addition to LC improves diastolic function and assess its impact in functional capacity and health-related quality of life ( HRQoL ) .
-METHODS	MET-DIME is a phase II prospective , randomized , open-label , blinded-endpoint trial with a scheduled follow-up of 24months .
-METHODS	Fifty-four patients ( adults 40-65years old with AHA/NHLBI criteria of MS and rest LVDD ) will be randomized by minimization to LC only or LC plus metformin ( target dose of 1,000 mg twice daily ) .
-METHODS	The primary endpoint will be change in mean of early diastolic mitral annular velocity , an echocardiographic parameter highly correlated with myocardial fibrosis ( serial measurements will be performed at 6 , 12 and 24months ) .
-METHODS	The secondary endpoints will include change in diastolic parameters at rest ; metabolic , inflammatory and remodeling biomarkers ; functional capacity ; adipose tissue volumes and HRQoL .
-CONCLUSIONS	MET-DIME is a pragmatic trial designed to evaluate if adding metformin to the standard treatment of patients with MS improves diastolic dysfunction , assessing its impact in metabolic homeostasis , proinflammatory state , functional capacity and HRQoL .
-
-###24667715
-BACKGROUND	EndoTAG-1 , composed of paclitaxel embedded in liposomal membranes targeting tumor endothelial cells , was evaluated for safety and efficacy in advanced triple-negative breast cancer ( TNBC ) .
-METHODS	One hundred and forty patients were treated with weekly EndoTAG-1 ( 22 mg/m ( 2 ) ) plus paclitaxel ( 70 mg/m ( 2 ) ) , twice weekly EndoTAG-1 ( 2 44 mg/m ( 2 ) ) , or weekly paclitaxel ( 90 mg/m ( 2 ) ) for greater than or equal to four cycles ( 3-week treatment + 1-week rest ) or until progression/toxicity .
-METHODS	Primary end point was progression-free survival ( PFS ) rate evaluated centrally after four cycles of therapy ( week 16 ) .
-METHODS	The study was not powered for intergroup comparisons .
-RESULTS	The PFS rate at week 16 was 59.1 % [ one-sided 95 % CI : 45.6 , ] on combination treatment , 34.2 % [ 21.6 , ] on EndoTAG-1 , and 48.0 % [ 30.5 , ] on paclitaxel .
-RESULTS	Median PFS reached 4.2 , 3.4 , and 3.7 months , respectively .
-RESULTS	After complete treatment ( week 41 analysis ) , median overall survival ( OS ) was 13.0 , 11.9 , and 13.1 months for the modified Intention-to-Treat ( ITT ) population and 15.1 , 12.5 , and 8.9 months for the per-protocol population , respectively .
-RESULTS	The clinical benefit rate was 53 % , 31 % , and 36 % for the treatment groups .
-RESULTS	Safety analysis revealed known toxicities of the drugs with slight increases of grade 3/4 neutropenia on combination therapy .
-CONCLUSIONS	Treatment of advanced TNBC with a combination of EndoTAG-1 and standard paclitaxel [ Taxol ( Bristol-Myers Squibb GmbH ) , or equivalent generic formulation ] was well tolerated and showed antitumor efficacy .
-CONCLUSIONS	The positive trend needs to be confirmed in a randomized phase III trial .
-BACKGROUND	European Clinical Trials Database : EudraCT number 2006-002221-23 .
-BACKGROUND	ClinicalTrials.gov identifier : NCT00448305 .
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-###25854020
-OBJECTIVE	To compare the difference in the clinical efficacy on infantile Tourette syndrome between the integrated therapy of acupuncture and pingganjianpi decoction and haloperidol tablets .
-METHODS	Forty-seven children were randomized into an observation group ( 25 cases ) and a control group ( 22 cases ) .
-METHODS	In the observation group , acupuncture was applied to Taichong ( LR 3 ) , Baihui ( GV 20 ) , Zhongwan ( CV 12 ) , Zusanli ( ST 36 ) , etc. .
-METHODS	The needles were retained for 30 min .
-METHODS	Acupuncture was given once a day and there were 5 days at intervals after 10 times of acupuncture .
-METHODS	Additionally , pinggan jianpi decoction was prescribed .
-METHODS	In the control group , haloperidol tablets were prescribed , starting from the small dose , 0.05 mg/kg per day , twice a day .
-METHODS	The treatment of 30 days made one session and 3 sessions were required .
-METHODS	Yale global tic severity scale ( YGTSS ) was adopted to observe tic time , tic frequency and tic severity score before treatment and in 30 days , 60 days and 90 days after treatment in the two groups .
-METHODS	The efficacy and adverse reactions were compared between the two groups .
-RESULTS	The total effective rates were 40.0 % ( 10/25 ) , 64.0 % ( 16/25 ) and 76.0 % ( 19/25 ) in the observation group and were 59.1 % ( 13/22 ) , 68.2 % ( 15/22 ) and 77.3 % ( 17/22 ) in the control group in 30 days , 60 days and 90 days after treatment respectively .
-RESULTS	The effect in 30 days after treatment in the control group was better than that in the observation group ( P < 0.05 ) .
-RESULTS	The differences at the other time points were not significant between the two groups ( all P > 0.05 ) .
-RESULTS	The tic time , tic frequency and tic severity score at the each time point after treatment were reduced obviously as compared with those before treatment ( all P < 0.05 ) .
-RESULTS	Each item score in the control group was reduced obviously as compared with that in the observation group in 30 days after treatment ( all P < 0.05 ) .
-RESULTS	The differences at the other time points were not significant between the two groups ( all P > 0.05 ) .
-RESULTS	The probability of adverse reaction in the observation group was less than that in the control group .
-CONCLUSIONS	The integrated therapy of acupuncture and medicine achieves the similar effect on infantile Tourette syndrome to haloperidol tablets and the side effects of it are less .
-
-###25710287
-OBJECTIVE	Faldaprevir is a potent , once-daily hepatitis C virus ( HCV ) NS3/4A protease inhibitor .
-OBJECTIVE	STARTVerso4 assessed the efficacy and safety of faldaprevir and response-guided pegylated interferon -2 a/ribavirin ( PegIFN/RBV ) in individuals with HCV/HIV co-infection .
-METHODS	A phase 3 open-label study ( NCT01399619 ) .
-METHODS	Individuals ( N = 308 ) co-infected with HCV genotype 1 ( treatment-naive or prior interferon relapsers ) and HIV [ 96 % on antiretroviral therapy ( ART ) ] received faldaprevir 120mg ( N = 123 ) or 240mg ( N = 185 ) and PegIFN/RBV .
-METHODS	Those receiving a protease inhibitor or efavirenz ART were assigned to faldaprevir 120 or 240mg , respectively .
-METHODS	Individuals achieving early treatment success ( ETS ; HCV RNA < 25IU/ml at week 4 and undetectable at week 8 ) were randomized to 24 or 48 weeks of PegIFN/RBV .
-METHODS	The primary endpoint was sustained virologic response 12 weeks after treatment ( SVR12 ) .
-RESULTS	SVR12 was achieved in 221 ( 72 % ) individuals , and the rates were comparable across faldaprevir doses .
-RESULTS	ETS was achieved in 80 % , and of these 86 % achieved SVR12 , with comparable rates with 24 and 48 weeks of PegIFN/RBV ( 87 and 94 % , respectively ) .
-RESULTS	In multivariate analysis , age below 40 years , IL28B CC genotype , and baseline HCV RNA below 800000IU/ml were associated with SVR12 ( P = 0.027 , P < 0.0001 , and P = 0.0002 , respectively ) , whereas treatment ( ART regimen and faldaprevir dose ) , liver cirrhosis , and genotype 1 subtype were not .
-RESULTS	The safety profile was comparable to that of faldaprevir in HCV-monoinfected individuals .
-CONCLUSIONS	High SVR12 rates were achieved with faldaprevir and PegIFN/RBV in HIV/HCV co-infected individuals , regardless of faldaprevir dose and background ART , HCV genotype 1 subtype , or cirrhosis status .
-CONCLUSIONS	SVR rates mirrored those obtained with similar regimens in HCV monoinfected individuals .
-
-###24296957
-OBJECTIVE	To compare the short-term clinical performance of two dual-disinfectant multipurpose disinfecting solutions ( MPDS ) when used in conjunction with two silicone hydrogel contact lenses .
-METHODS	Participants wore galyfilcon A and balafilcon A lenses , randomly allocated one type to each eye .
-METHODS	Multipurpose disinfecting solutions were double-masked and allocated using a randomized crossover design .
-METHODS	Lenses were presoaked overnight in the allocated MPDS , containing either polyquaternium-1 / alexidine dihydrochloride ( PQ-alexidine ) or polyquaternium-1 / myristamidopropyl dimethylamine ( PQ-MAPDA ) .
-METHODS	Lenses were worn daily for 4 days and disinfected with the same MPDS in which they had been soaked .
-METHODS	Clinical assessments occurred immediately after insertion , 2 hours after insertion , and after 2 hours of wear on day 4 .
-METHODS	Subjective ratings were collected at each assessment and after 6 hours of wear on days 1 to 3 .
-METHODS	Linear mixed models were used for statistical analysis .
-RESULTS	Solution-induced corneal staining ( SICS ) incidence was significantly different between MPDS lens combinations ( P = 0.01 ) with PQ-MAPDA-balafilcon A showing the highest incidence ( 27.8 % ) .
-RESULTS	The incidence of SICS was significantly higher when balafilcon A lenses were worn compared with galyfilcon A ( 19.4 % vs. 2.8 % ; P = 0.04 ) .
-RESULTS	There was no significant difference in SICS incidence between MPDS ( PQ-alexidine = 5.6 % , PQ-MAPDA = 16.7 % ; P = 0.08 ) .
-RESULTS	Polyquaternium-1 / alexidine dihydrochloride was associated with significantly fewer symptoms of burning/stinging ( 9.70.6 vs. 9.12.2 ; P = 0.03 ) and self-assessed redness ( 9.80.5 vs. 9.21.9 ; P = 0.03 ) on initial lens insertion .
-RESULTS	There were no significant differences between MPDS for comfort ratings ( P > 0.05 ) .
-CONCLUSIONS	These short-term clinical results provide an initial indication that PQ-alexidine is associated with fewer symptoms on insertion but no significant difference in ocular comfort compared with PQ-MAPDA .
-CONCLUSIONS	Longer studies are required to provide further evidence .
-
-###24993395
-OBJECTIVE	Acute radiation cystitis , inflammation of the bladder , is a common side effect in men receiving external beam radiation for prostate cancer .
-OBJECTIVE	Although several treatments provide symptomatic relief , there is no effective treatment to prevent or treat radiation cystitis .
-OBJECTIVE	Cranberry products have been associated with urinary tract health .
-OBJECTIVE	This study aimed to determine the effect of highly standardized cranberry capsules ( containing 72 mg proanthocyanidins [ PACS ] ) compared with that of placebo capsules on the incidence and severity of radiation cystitis .
-METHODS	Forty-one men with prostate cancer participated in a double blinded randomized placebo controlled study .
-METHODS	Men took one capsule a day at breakfast during treatment and for 2 weeks after treatment completion .
-METHODS	Severity of urinary symptoms and the bother these caused were measured using the individual items of the urinary domain of the Modified Expanded Prostate Index Composite ( EPIC ) .
-RESULTS	The incidence of cystitis was lower in men taking cranberry capsules ( 65 % ) compared with those that took placebo capsules ( 90 % ) ( p = 0.058 ) ; severe cystitis was seen in 30 % of men in the cranberry arm and 45 % in the placebo arm ( p = 0.30 ) .
-RESULTS	Overall , the incidence of pain/burning was significantly lower in the cranberry cohort ( p = 0.045 ) .
-RESULTS	Men on the low hydration regimen who took cranberry had less pain/burning ( p = 0.038 ) , stronger urine steam ( p = 0.030 ) and used significantly fewer pads/liners ( p = 0.042 ) , which was significantly different from those on the high hydration regimen ( p = 0.028 ) .
-CONCLUSIONS	Men receiving radiation therapy for prostate cancer may benefit from using cranberry capsules , particularly those on low hydration regimens or with baseline urinary symptoms .
-
-###24710254
-BACKGROUND	Endoscopic minimally invasive surgery of the cervical region is currently used to treat benign thyroid disease .
-BACKGROUND	The aim of this study was to evaluate the safety , feasibility , and inflammatory response to endoscopic thyroidectomy ( ET ) via an anterior chest wall approach .
-METHODS	Between January 2007 and January 2012 , 320 patients underwent sub-total/total thyroidectomy .
-METHODS	Of these , 160 had endoscopic surgery through an anterior chest wall approach ( ET , group A ) and 160 had traditional open surgery ( group B ) .
-METHODS	Demographics , operation time , intraoperative blood loss , complications , hospital stay , cost , and postoperative outcomes were compared between the 2 groups .
-METHODS	Serum Interleukin-6 and C-reactive protein levels were measured preoperatively and at 2 , 12 , 24 , and 48 hours postoperatively .
-RESULTS	Patient demographics , tumor size , operation time , and pathologic diagnoses were similar in both groups .
-RESULTS	There was no difference in procedure time and postoperative complication rates .
-RESULTS	Intraoperative blood loss and length of hospital stay were significantly lower in group A ( P < 0.05 ) , but cost was higher ( P < 0.05 ) .
-RESULTS	Serum Interleukin-6 and C-reactive protein levels increased significantly after both procedures , with levels at the 24-hour and 48-hour time points higher in group B ( P < 0.05 ) .
-RESULTS	Two cases in group A and 1 in group B developed a transient hoarse voice postoperatively , which recovered 7.5 days ( range , 5 to 12 d ) later .
-RESULTS	There were no serious complications during the 2-year follow-up .
-CONCLUSIONS	ET through an anterior chest wall approach is safe and feasible for benign thyroid disease , and offers the advantage of no visible scar .
-
-###25899986
-BACKGROUND	The BELOB study , a randomised controlled phase 2 trial comparing lomustine , bevacizumab and combined lomustine and bevacizumab in patients with recurrent glioblastoma , showed that the 9-month overall survival rate was most promising in the combination arm .
-BACKGROUND	Here we report the health-related quality of life ( HRQoL ) results , a secondary trial end-point .
-METHODS	HRQoL was measured at baseline and every 6weeks until progression using the European Organisation for Research and Treatment of Cancer ( EORTC ) core questionnaire ( QLQ-C30 ) and brain module ( QLQ-BN20 ) .
-METHODS	HRQoL was assessed over time for five preselected scales ( global health ( GH ) , physical ( PF ) and social functioning ( SF ) , motor dysfunction ( MD ) and communication deficit ( CD ) ) .
-METHODS	Moreover , mean changes in HRQoL from baseline until progression were determined .
-RESULTS	138/148 patients with at least a baseline HRQoL assessment were analysed .
-RESULTS	Over time , HRQoL remained relatively stable in all treatment arms for all five scales , at least during the first three treatment cycles .
-RESULTS	More than half ( 54-61 % ) of the patients showed stable ( < 10 point change ) or improved ( 10 point change ) HRQoL during their progression-free time , except for SF ( 43 % ) , irrespective of treatment arm .
-RESULTS	Deterioration of mean HRQoL was most profound at disease progression for all scales except SF , which deteriorated earlier in disease course .
-RESULTS	Compared to baseline , 40 % of patients had clinically relevant ( 10 points ) worse GH , PF and SF , while 44 % and 31 % had increased MD and CD at disease progression , irrespective of treatment arm .
-CONCLUSIONS	Bevacizumab , whether or not in combination with lomustine , did not negatively affect HRQoL in patients treated for recurrent glioblastoma in this randomised study .
-
-###25271206
-OBJECTIVE	To investigate the efficacy , safety , and tolerability of empagliflozin in patients with type 2 diabetes and hypertension .
-METHODS	Patients ( N = 825 ) with type 2 diabetes and hypertension ( mean seated systolic blood pressure [ SBP ] 130-159 mmHg and diastolic blood pressure [ DBP ] 80-99 mmHg ) were randomized ( double blind ) to 10 mg or 25 mg empagliflozin or placebo once daily for 12 weeks .
-RESULTS	At week 12 , adjusted mean difference versus placebo in change from baseline in mean 24-h SBP ( ambulatory blood pressure monitoring [ ABPM ] ) was -3.44 mmHg ( 95 % CI -4.78 , -2.09 ) with 10 mg empagliflozin and -4.16 mmHg ( -5.50 , -2.83 ) with 25 mg empagliflozin ( both P < 0.001 ) .
-RESULTS	At week 12 , adjusted mean difference versus placebo in change from baseline in mean 24-h DBP ( ABPM ) was -1.36 mmHg ( 95 % CI -2.15 , -0.56 ) with 10 mg empagliflozin and -1.72 mmHg ( 95 % CI -2.51 , -0.93 ) with 25 mg empagliflozin ( both P < 0.001 ) .
-RESULTS	Changes in office BP were consistent with ABPM .
-RESULTS	Adjusted mean difference versus placebo in change from baseline in HbA1c at week 12 was -0.62 % ( 95 % CI -0.72 , -0.52 ) ( -6.8 mmol/mol [ 95 % CI -7.9 , -5.7 ] ) with 10 mg empagliflozin and -0.65 % ( 95 % CI -0.75 , -0.55 ) ( -7.1 mmol/mol [ 95 % CI -8.2 , -6.0 ] ) with 25 mg empagliflozin ( both P < 0.001 ) .
-RESULTS	Empagliflozin was well tolerated .
-RESULTS	One patient on placebo and one patient on 10 mg empagliflozin reported events consistent with volume depletion .
-CONCLUSIONS	Empagliflozin was associated with significant and clinically meaningful reductions in BP and HbA1c versus placebo and was well tolerated in patients with type 2 diabetes and hypertension .
-
-###25675557
-OBJECTIVE	To observe the impact on lower limbs balance function in treatment of yin-yang meridians acupuncture with respiratory reinforcing and reducing manipulation involved in the patients of stroke by applying B-PHY balance function test training system so as to provide the objective evidence in treatment of stroke ; with acupuncture .
-METHODS	One hundred patients were randomized into an observation group and a control group , 50 cases in each one .
-METHODS	In the control group , the basic treatment was applied , without other relevant rehabilitation therapies associated .
-METHODS	In the observation group , with the basic treatment as the control group 's , the therapy of the yin-yang meridians acupuncutre with respiratory reinforcing and reducing manipulation was adopted .
-METHODS	On the yin meridians , Zuwuli ( LR 10 ) , Xuehai ( SP 10 ) , Yinlingquan ( SP 9 ) , Sanyinjiao ( SP 6 ) and the others were selected and stimulated with reducing manipulation achieved by the coordination of patient 's respiration .
-METHODS	On the yang meridians , Biguan ( ST 31 ) , Liangqiu ( ST 34 ) , Yanglingquan ( GB 34 ) and the others were selected and stimulated with reinforcing manipulation achieved by the coordination of patient 's respiration .
-METHODS	The treatment was given once a day and for 28 days totally .
-METHODS	Before treatment and in 28 days of treatment , B-PHY balance function test training system was used to determine the weight shift track parameters ( track length , peripheral square , track length of per unit square , left-right offset and rectangle square ) , the weight shift track distance parameters [ mean of X axle weight shift distance ( Mean-X ) , mean of Y axle weight shift distance ( Mean-Y ) , maximum of X axle weight shift distance ( Max-X ) , maximum of Y axle weight shift distance ( Max-Y ) , weight shift distance ( LSKG ) , weight shift square ( SSKG ) , square ratio of weight shift ( LFS ) ] , stability coefficient ( SI ) and weight distribution coefficient ( WDI ) .
-RESULTS	After treatment , the differences in the weight shift track parameters , SI and WDI were significant as compared with those before treatment in the patients of the two groups ( all P < 0.01 ) ; while the differences in the weight shift distance parameters in the observation group were improved obviously after treatment as compared with those before treatment ( all P < 0.01 ) , the differences of Mean-X , Max-Y and LFS in the control group were improved after treatment as compared with those before treatment ( all P < 0.01 ) .
-RESULTS	Except SSKG , the improvements after treatment in the rest indices in the observation group were better than those in the control group ( all P < 0.05 ) .
-CONCLUSIONS	The yin-yang meridians acupuncture with respiratry reinforcing and re - ducing manipulation effectively improves the lower limbs balance function in the patients of stroke .
-
-###24568495
-BACKGROUND	Although the cause in most cases of childhood leukemia is not known , the contribution of environmental risk factors in the context of genetic predisposition has been reported with inconsistent results .
-BACKGROUND	The aim of this study was to examine association of childhood leukemia with maternal factors especially during pregnancy , to help in avoiding risk factors .
-METHODS	This case-control study included children younger than 18 years diagnosed with leukemia from 2008 to 2012 .
-METHODS	Controls were randomly selected and individually matched to cases with respect to age , sex , and residency .
-METHODS	All variables were compared between cases and control to determine any significant association with leukemia .
-RESULTS	Statistically significant associations between risk of childhood leukemia with mother 's education ( p = 0.001 ) , occupation ( p = 0.0005 ) and pesticides exposure ( p = 0.005 ) during pregnancy were found .
-RESULTS	However , there were no significant links with maternal age ( p = 0.090 ) , history of fetal loss ( 0.85 ) , history of radiography during pregnancy ( p = 0.400 ) , history of drug intake ( p = 0.689 ) and infection ( p = 0.696 ) during pregnancy .
-CONCLUSIONS	The results showed increased risk of leukemia in children whose mothers were working in agriculture and were exposed to pesticides during pregnancy .
-CONCLUSIONS	The further study needs to be investigated to know association of various maternal risk factors with leukemia which remained unknown in this study .
-
-###24523037
-OBJECTIVE	Inflammatory biomarkers predict incident and recurrent cardiac events , but their relationship to stroke prognosis is uncertain .
-OBJECTIVE	We hypothesized that high-sensitivity C-reactive protein ( hsCRP ) predicts recurrent ischemic stroke after recent lacunar stroke .
-METHODS	Levels of Inflammatory Markers in the Treatment of Stroke ( LIMITS ) was an international , multicenter , prospective ancillary biomarker study nested within Secondary Prevention of Small Subcortical Strokes ( SPS3 ) , a phase III trial in patients with recent lacunar stroke .
-METHODS	Patients were assigned in factorial design to aspirin versus aspirin plus clopidogrel , and higher versus lower blood pressure targets .
-METHODS	Patients had blood samples collected at enrollment and hsCRP measured using nephelometry at a central laboratory .
-METHODS	Cox proportional hazard models were used to calculate hazard ratios ( HRs ) and 95 % confidence intervals ( 95 % CIs ) for recurrence risks before and after adjusting for demographics , comorbidities , and statin use .
-RESULTS	Among 1244 patients with lacunar stroke ( mean age , 63.310.8 years ) , median hsCRP was 2.16 mg/L .
-RESULTS	There were 83 recurrent ischemic strokes ( including 45 lacunes ) and 115 major vascular events ( stroke , myocardial infarction , and vascular death ) .
-RESULTS	Compared with the bottom quartile , those in the top quartile ( hsCRP > 4.86 mg/L ) were at increased risk of recurrent ischemic stroke ( unadjusted HR , 2.54 ; 95 % CI , 1.30-4 .96 ) , even after adjusting for demographics and risk factors ( adjusted HR , 2.32 ; 95 % CI , 1.15-4 .68 ) .
-RESULTS	hsCRP predicted increased risk of major vascular events ( top quartile adjusted HR , 2.04 ; 95 % CI , 1.14-3 .67 ) .
-RESULTS	There was no interaction with randomized antiplatelet treatment .
-CONCLUSIONS	Among recent lacunar stroke patients , hsCRP levels predict the risk of recurrent strokes and other vascular events .
-CONCLUSIONS	hsCRP did not predict the response to dual antiplatelets .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00059306 .
-
-###24642140
-OBJECTIVE	To evaluate the effectiveness of the Healthy Directions 2 ( HD2 ) intervention in the primary care setting .
-METHODS	HD2 was a cluster randomized trial ( conducted 3/09-11 / 11 ) .
-METHODS	The primary sampling unit was provider ( n = 33 ) , with secondary sampling of patients within provider ( n = 2440 ) .
-METHODS	Study arms included : 1 ) usual care ( UC ) ; 2 ) HD2 -- a patient self-guided intervention targeting 5 risk behaviors ; and 3 ) HD2 plus 2 brief telephone coaching calls ( HD2 + CC ) .
-METHODS	The outcome measure was the proportion of participants with a lower multiple risk behavior ( MRB ) score by follow-up .
-RESULTS	At baseline , only 4 % of the participants met all behavioral recommendations .
-RESULTS	Both HD2 and HD2 + CC led to improvements in MRB score , relative to UC , with no differences between the two HD2 conditions .
-RESULTS	Twenty-eight percent of the UC participants had improved MRB scores at 6 months , vs. 39 % and 43 % in HD2 and HD2 + CC , respectively ( ps .001 ) ; results were similar at 18 months ( p. 05 ) .
-RESULTS	The incremental cost of one risk factor reduction in MRB score was $ 310 for HD2 and $ 450 for HD2 + CC .
-CONCLUSIONS	Self-guided and coached intervention conditions had equivalent levels of effect in reducing multiple chronic disease risk factors , were relatively low cost , and thus are potentially useful for routine implementation in similar health settings .
-
-###26106946
-BACKGROUND	The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis .
-BACKGROUND	Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery , potentially improving vessel patency by reducing restenosis .
-METHODS	In this single-blind , randomized trial conducted at 54 sites , we assigned , in a 2:1 ratio , 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty .
-METHODS	The primary efficacy end point was primary patency of the target lesion at 12 months ( defined as freedom from binary restenosis or from the need for target-lesion revascularization ) .
-METHODS	The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death ( i.e. , death from a medical complication related to a limb ) , amputation , and reintervention .
-RESULTS	The two groups were well matched at baseline ; 42.9 % of the patients had diabetes , and 34.7 % were current smokers .
-RESULTS	At 12 months , the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty ( 65.2 % vs. 52.6 % , P = 0.02 ) .
-RESULTS	The proportion of patients free from primary safety events was 83.9 % with the drug-coated balloon and 79.0 % with standard angioplasty ( P = 0.005 for noninferiority ) .
-RESULTS	There were no significant between-group differences in functional outcomes or in the rates of death , amputation , thrombosis , or reintervention .
-CONCLUSIONS	Among patients with symptomatic femoropopliteal peripheral artery disease , percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon .
-CONCLUSIONS	The drug-coated balloon was noninferior to the standard balloon with respect to safety .
-CONCLUSIONS	( Funded by Lutonix-Bard ; LEVANT 2 ClinicalTrials.gov number , NCT01412541 . )
-
-###24257722
-BACKGROUND	The intake of whey , compared with casein and soy protein intakes , stimulates a greater acute response of muscle protein synthesis ( MPS ) to protein ingestion in rested and exercised muscle .
-OBJECTIVE	We characterized the dose-response relation of postabsorptive rates of myofibrillar MPS to increasing amounts of whey protein at rest and after exercise in resistance-trained , young men .
-METHODS	Volunteers ( n = 48 ) consumed a standardized , high-protein ( 0.54 g/kg body mass ) breakfast .
-METHODS	Three hours later , a bout of unilateral exercise ( 8 10 leg presses and leg extensions ; 80 % one-repetition maximum ) was performed .
-METHODS	Volunteers ingested 0 , 10 , 20 , or 40 g whey protein isolate immediately ( ~ 10 min ) after exercise .
-METHODS	Postabsorptive rates of myofibrillar MPS and whole-body rates of phenylalanine oxidation and urea production were measured over a 4-h postdrink period by continuous tracer infusion of labeled [ ( 13 ) C6 ] phenylalanine and [ ( 15 ) N2 ] urea .
-RESULTS	Myofibrillar MPS ( mean SD ) increased ( P < 0.05 ) above 0 g whey protein ( 0.041 0.015 % / h ) by 49 % and 56 % with the ingestion of 20 and 40 g whey protein , respectively , whereas no additional stimulation was observed with 10 g whey protein ( P > 0.05 ) .
-RESULTS	Rates of phenylalanine oxidation and urea production increased with the ingestion of 40 g whey protein .
-CONCLUSIONS	A 20-g dose of whey protein is sufficient for the maximal stimulation of postabsorptive rates of myofibrillar MPS in rested and exercised muscle of ~ 80-kg resistance-trained , young men .
-CONCLUSIONS	A dose of whey protein > 20 g stimulates amino acid oxidation and ureagenesis .
-CONCLUSIONS	This trial was registered at http://www.isrctn.org/ as ISRCTN92528122 .
-
-###24681572
-OBJECTIVE	Dietary nitrate supplementation positively affects cardiovascular function at rest and energy metabolism during exercise in humans and has recently also been reported to markedly enhance the in vitro contractile properties of mouse fast-twitch muscle .
-OBJECTIVE	The aim of this study was to investigate the effects of short-term nitrate supplementation on the in vivo contractile properties of the skeletal muscle and voluntary muscle function of humans .
-METHODS	In a double-blind , randomized , crossover design , 19 healthy untrained men ( 21 3 yr ) ingested a nitrate-rich concentrated beetroot juice ( NIT ; nitrate dosage , approximately 9.7 mmold ) and a placebo ( PLA ) for seven consecutive days .
-METHODS	After the last supplementation dose , force was recorded while participants completed a series of voluntary and involuntary ( electrically evoked ) unilateral isometric contractions of the knee extensors .
-RESULTS	NIT enhanced the peak force response to low-frequency electrical stimulation , as follows : maximal twitch ( NIT , 149 41 N , vs PLA , 138 37 N ; P = 0.008 ; effect size , r ( ES ) = 0.56 ) and submaximal 1 - to 20-Hz contractions ( 5 % -10 % , ES = 0.53-0 .63 ) .
-RESULTS	Whereas explosive ( rising phase ) force production during the first 50 ms of evoked maximal twitch and octet contractions ( eight electrical impulses at 300 Hz ) was also 3 % -15 % greater after NIT compared with that after PLA ( P = 0.023-0 .048 , ES = 0.52-0 .59 ) , explosive voluntary force remained similar ( P = 0.510 , ES = 0.16 ) .
-RESULTS	Maximum voluntary force was also unchanged after NIT ( P = 0.539 , ES = 0.15 ) .
-CONCLUSIONS	These results indicate that 7 d of dietary nitrate supplementation enhanced the in vivo contractile properties of the human skeletal muscle .
-CONCLUSIONS	Specifically , nitrate supplementation improved excitation-contraction coupling at low frequencies of stimulation and enhanced evoked explosive force production but did not affect maximum or explosive voluntary force production in untrained individuals .
-
-###25302753
-OBJECTIVE	It has been suggested that home-based heart failure ( HF ) management in primary care may be an alternative to clinic-based management in HF patients .
-OBJECTIVE	However , little is known about adherence to HF guidelines and adherence to the medication regimen in these home-based programmes .
-OBJECTIVE	The aim of the current study was to determine whether long-term follow-up and treatment in primary care is equally effective as follow-up at a specialized HF clinic in terms of guideline adherence and patient adherence , in HF patients initially managed and up-titrated to optimal treatment at a specialized HF clinic .
-RESULTS	We conducted a multicentre , randomized , controlled study in 189 HF patients ( 62 % male , age 72 11 years ) , who were assigned to follow-up either in primary care ( n = 97 ) or in a HF clinic ( n = 92 ) .
-RESULTS	After 12 months , no differences between guideline adherence , as estimated by the Guideline Adherence Indicator ( GAI-3 ) , and patient adherence , in terms of the medication possession ratio ( MPR ) , were found between treatment groups .
-RESULTS	There was no difference in the number of deaths ( n = 12 in primary care and n = 8 in the HF clinic ; P = 0.48 ) , and hospital readmissions for cardiovascular ( CV ) reasons were also similar .
-RESULTS	The total number of unplanned non-CV hospital readmissions , however , tended to be higher in the primary care group ( n = 22 ) than in the HF clinic group ( n = 10 ; P = 0.05 ) .
-CONCLUSIONS	Patients discharged after initial management in a specialized HF clinic can be discharged to primary care for long-term follow-up with regard to maintaining guideline adherence and patient adherence .
-CONCLUSIONS	However , the complexity of the HF syndrome and its associated co-morbidities requires continuous monitoring .
-CONCLUSIONS	Close collaboration between healthcare providers will be crucial in order to provide HF patients with optimal , integrated care .
-
-###24388126
-OBJECTIVE	To assess the effect of a group-based intervention on the balance between necessity beliefs and concern beliefs about medication and on medication non-adherence in patients with rheumatoid arthritis ( RA ) .
-METHODS	Non-adherent RA patients using disease-modifying anti-rheumatic drugs ( DMARDs ) were randomized to an intervention or control arm .
-METHODS	The intervention consisted , amongst others , of two motivational interviewing-guided group sessions led by the same pharmacist .
-METHODS	Control patients received brochures about their DMARDs .
-METHODS	Questionnaires were completed up to 12 months follow-up .
-RESULTS	123 patients ( mean age : 60 years , female : 69 % ) were randomized .
-RESULTS	No differences in necessity beliefs and concern beliefs about medication and in medication non-adherence were detected between the intervention and control arm , except at 12 months ' follow-up : participants in the intervention arm had less strong necessity beliefs about medication than participants in the control arm ( b : -1.0 ( 95 % CI : -2.0 , -0.1 ) ) .
-CONCLUSIONS	This trial did not demonstrate superiority of our intervention over the control arm in changing beliefs about medication or in improving medication adherence over time .
-CONCLUSIONS	Absent intervention effects might have been due to , amongst others , selection bias and a suboptimal treatment integrity level .
-CONCLUSIONS	Hence , targeting beliefs about medication in clinical practice should not yet be ruled out .
-
-###25073008
-OBJECTIVE	To evaluate the effects of sacral magnetic stimulation ( SMS ) on functional and urodynamic improvement in patients with refractory stress urinary incontinence ( SUI ) .
-METHODS	A sham-controlled , double-blind , parallel study design with a 4.5-month follow-up .
-METHODS	A tertiary hospital .
-METHODS	Women ( age , 45-75y ) with SUI refractory to first-line management ( N = 34 ) were allocated to either an experimental ( n = 20 ) group or a sham ( n = 14 ) group .
-METHODS	The SMS protocol consisted of 5-Hz , 20-minute treatments administered over the bilateral third sacral roots , with the intensity set at approximately 70 % of the maximal output , for 12 consecutive weekdays .
-METHODS	Urodynamic assessments and 2 life stress questionnaires , namely , the Urge-Urinary Distress Inventory ( U-UDI ) and the Overactive Bladder Questionnaire ( OAB-q ) , were administered pre - and post-SMS intervention .
-METHODS	We administered the U-UDI ( primary outcome measure ) and the OAB-q at 3-week intervals during the follow-up period until 18 weeks after the final intervention .
-RESULTS	The experimental group exhibited significant improvements in both U-UDI and OAB-q scores postintervention ( P = .011 -.014 ) and at follow-up visits ( P < .001 -.007 ) compared with the sham group .
-RESULTS	In addition , significant increases in bladder capacity , urethral functional length , and the pressure transmission ratio ( P = .009 -.033 ) were noted postintervention .
-RESULTS	Multivariate regression analysis revealed that patients with more severe symptoms benefited more from SMS .
-RESULTS	A poorer baseline U-UDI score and a shorter urethral functional length were associated with a greater response to SMS .
-CONCLUSIONS	Our observations of a greater response to SMS in patients with more severe SUI than in those with mild symptoms , as well as the long-term benefits of the treatment , confirm the efficacy of SMS in treating SUI .
-
-###24843974
-OBJECTIVE	To evaluate clinical efficacy of electroacupuncture at Changqiang ( GV 1 ) and Chengshan ( BL 57 ) 30 min before surgery on postoperative pain and discomforts in patients with mixed hemorrhoids .
-METHODS	One hundred and twenty cases of mixed hemorrhoids who received Milligan-Morgan operation were randomly divided into an electroacupuncture group , a sham electroacupuncture group and a blank group , 40 cases in each one .
-METHODS	At the same time of basic treatment , the electroacupuncture was applied at Changqiang ( GV 1 ) and Chengshan ( BL 57 ) 30 min before surgery in the electroacupuncture group , while shallow needling without electrical stimulation at sham acupoint ( 1 cm next to acupoint ) was applied 30 min before surgery in the sham electroacupuncture group , while no treatment was given before the surgery in the blank group .
-METHODS	The total dose of painkillers in the first 24 h after operation , the number of cases who received additional anesthetic in the operation , the self-score of most severity pain in the first 24 h after operation and sleeping time in the night of surgery were observed .
-RESULTS	The differences of the numbers of cases who received additional anesthetic in the operation had no statistical significance among the three groups ( all P > 0.05 ) , but compared with the sham electroacupuncture group and blank group , the total dose of painkillers in the first 24 h after operation was reduced in the electroacupuncture group [ ( 2.43 + / - 1.08 ) tablets vs ( 3.23 + / - 1.33 ) tablets , ( 3.10 + / - 1.22 ) tablets ] , and the score of most severity pain was also decreased ( 6.65 + / - 1.00 vs 7.48 + / - 0.96 , 7.25 + / - 1.19 ) , besides , the sleeping time in the night of surgery was increased [ ( 220.63 + / - 85.50 ) min vs ( 162.00 + / - 92.69 ) min , ( 151.50 + / - 80.01 ) min , all P < 0.05 ] .
-CONCLUSIONS	The electroacupuncture at Changqiang ( GV 1 ) and Chengshan ( BL 57 ) 30 min before surgery has effects of preemptive analgesia on postoperative pain for patients with mixed hemorrhoids .
-
-###24511720
-OBJECTIVE	Evaluate the effect of intravenous fentanyl on the incidence and severity of EA .
-METHODS	In the clinical trial , 144 patients aged between two and nine years , scheduled for elective surgery were enrolled and randomly assigned to receive either fentanyl 1 microg/kg or normal saline 1 ml/10 kg , 15 minutes before the end of surgery .
-METHODS	Watcha 's behavioral emergence delirium scale was used to assess EA .
-RESULTS	The incidence of EA was lower in the fentanyl group ( 11/72 vs. 23/72 person respectively , p = 0.03 ) .
-RESULTS	However there was no statistically significant difference in the number of patients with severe EA ( 1/72 vs. 6/72 person respectively , p = 0.12 ) .
-RESULTS	Fewer number of patients in the fentanyl group had moderate to severe pain when compared with the control group ( 16/72 vs. 30/72 person respectively , p = 0.02 ) .
-RESULTS	The number of patient who required rescue analgesia was significantly lower in the fentanyl group ( 18/72 vs. 30/72 person respectively , p = 0.04 ) .
-RESULTS	There were no statistically significant differences in terms of emergence time , postoperative adverse events , and length of stay in the post-anesthetic care unit between the two groups .
-CONCLUSIONS	Administration of intravenous fentanyl 1 microg/kg 15 minutes prior the end of surgery decreased the incidence of EA and reduced pain without delaying emergence and without any increase in postoperative complications .
-
-###26244299
-OBJECTIVE	Abnormal choroidal blood flow is considered important in the pathogenesis of chronic central serous chorioretinopathy ( CSC ) .
-OBJECTIVE	Optical coherence tomography ( OCT ) angiography can image ocular blood cell flow and could thus provide novel insights in disease mechanisms of CSC .
-OBJECTIVE	We evaluated depth-resolved flow in chronic CSC by OCT angiography compared to fluorescein angiography ( FA ) and indocyanine green angiography ( ICGA ) .
-METHODS	Eighteen eyes with chronic CSC , and six healthy controls , were included .
-METHODS	Two human observers annotated areas of staining , hypofluorescence , and hotspots on FA and ICGA , and areas of abnormal flow on OCT angiography .
-METHODS	Interobserver agreement in annotating OCT angiography and FA/ICGA was measured by Jaccard indices ( JIs ) .
-METHODS	We assessed colocation of flow abnormalities and subretinal fluid visible on OCT , and the distance between hotspots on ICGA from flow abnormalities .
-RESULTS	Abnormal areas were most frequently annotated in late-phase ICGA and choriocapillary OCT angiography , with moderately high ( median JI , 0.74 ) and moderate ( median JI , 0.52 ) interobserver agreement , respectively .
-RESULTS	Abnormalities on late-phase ICGA and FA colocated with those on OCT angiography .
-RESULTS	Aberrant choriocapillary OCT angiography presented as foci of reduced flow surrounded by hyperperfused areas .
-RESULTS	Hotspots on ICGA were located near hypoperfused spots on OCT angiography ( mean distance , 168 m ) .
-RESULTS	Areas with current or former subretinal fluid were colocated with flow abnormalities .
-CONCLUSIONS	On OCT angiography , chronic CSC showed irregular choriocapillary flow patterns , corresponding to ICGA abnormalities .
-CONCLUSIONS	These results suggest focal choriocapillary ischemia with surrounding hyperperfusion that may lead to subretinal fluid leakage .
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-###25085447
-BACKGROUND	Psychological therapy is effective for symptoms of mental distress , but many groups with high levels of mental distress face significant barriers in terms of access to care , as current interventions may not be sensitive to their needs or their understanding of mental health .
-BACKGROUND	There is a need to develop forms of psychological therapy that are acceptable to these groups , feasible to deliver in routine settings , and clinically and cost effective .
-METHODS	We developed a culturally sensitive wellbeing intervention with individual , group and sign-posting elements , and tested its feasibility and acceptability for patients from ethnic minorities and older people in an exploratory randomised trial .
-RESULTS	We recruited 57 patients ( 57 % of our target ) from 4 disadvantaged localities in the NW of England .
-RESULTS	The results of the exploratory trial suggest that the group receiving the wellbeing interventions improved compared to the group receiving usual care .
-RESULTS	For elders , the largest effects were on CORE-OM and PHQ-9 .
-RESULTS	For ethnic minority patients , the largest effect was on PHQ-9 .
-RESULTS	Qualitative data suggested that patients found the intervention acceptable , both in terms of content and delivery .
-CONCLUSIONS	This exploratory trial provides some evidence of the efficacy and acceptability of a wellbeing intervention for older and ethnic minority groups experiencing anxiety and depression , although challenges in recruitment and engagement remain .
-CONCLUSIONS	Evidence from our exploratory study of wellbeing interventions should inform new substantive trial designs .
-BACKGROUND	Current controlled trials ISRCTN68572159 .
-
-###24446953
-OBJECTIVE	Brivaracetam ( BRV ) is a novel high-affinity synaptic vesicle protein 2A ligand currently being investigated for the treatment of epilepsy .
-OBJECTIVE	The purpose of this phase III study was to evaluate the efficacy and safety/tolerability of adjunctive BRV in adults with uncontrolled partial-onset ( focal ) seizures .
-METHODS	This was a prospective , multicenter , randomized , double-blind , placebo-controlled , parallel-group , fixed-dose trial ( N01253 ; NCT00464269 ) .
-METHODS	Adults aged 16-70 years with well-characterized partial epilepsy not fully controlled despite treatment with one or two antiepileptic drugs ( AEDs ) were enrolled .
-METHODS	Patients who experienced eight or more partial-onset seizures , whether or not secondarily generalized , during the 8-week prospective baseline period were randomized ( 1:1:1:1 ) to receive twice-daily placebo ( PBO ) or BRV ( 5 , 20 , or 50 mg/day ) without titration .
-METHODS	The primary efficacy endpoint was percent reduction over PBO in baseline-adjusted partial-onset seizure frequency/week during the 12-week treatment period .
-METHODS	Comparison of BRV with PBO was sequential ( 50 , 20 mg/day , then 5 mg/day ) .
-METHODS	Secondary endpoints included 50 % responder rate and median percent reduction from baseline in partial-onset seizure frequency/week .
-METHODS	Post hoc analyses included the primary efficacy endpoint evaluated over 28 days and exploratory subanalyses of efficacy by seizure subtype .
-METHODS	Safety and tolerability assessments included treatment-emergent adverse events ( TEAEs ) , laboratory tests , electrocardiography , vital signs , and physical and neurologic examinations .
-RESULTS	Of 400 patients randomized , 396 were included in the intent-to-treat ( ITT ) population ( PBO n = 98 , BRV 5 mg/day n = 97 , BRV 20 mg/day n = 100 , BRV 50 mg/day n = 101 ) and 392 comprised the modified ITT ( mITT ) population .
-RESULTS	A total of 361 ( 91.2 % ) of 396 patients completed the study .
-RESULTS	Most patients ( 78.3 % ) were receiving two concomitant AEDs .
-RESULTS	Percent reduction in partial-onset seizure frequency/week over PBO was -0.9 % ( p = 0.885 ) for BRV 5 mg/day , 4.1 % ( p = 0.492 ) for BRV 20 mg/day , and 12.8 % ( p = 0.025 ) for BRV 50 mg/day ( mITT population ) .
-RESULTS	Statistical significance was also achieved for the percent reduction over PBO in baseline-adjusted partial-onset seizure frequency/28 days for BRV 50 mg/day ( 22.0 % ; p = 0.004 ) but not for the other BRV dose groups .
-RESULTS	In the BRV 50 mg/day group , statistical significance was also seen for the 50 % responder rate ( BRV 32.7 % vs. PBO 16.7 % ; p = 0.008 ) and median percent reduction from baseline in partial-onset seizure frequency/week ( BRV 30.5 % vs. PBO 17.8 % ; p = 0.003 ) .
-RESULTS	In the exploratory subanalysis by seizure subtype , median percent reduction from baseline in seizure frequency/week and 50 % responder rate were numerically greater than PBO in the BRV 20 and 50 mg/day groups for simple partial , complex partial , and secondarily generalized seizures .
-RESULTS	BRV was generally well tolerated , with the majority of TEAEs being mild-to-moderate in intensity .
-RESULTS	Of the TEAEs reported by 5 % patients , those with a frequency > 3 % higher than PBO for any dose of BRV compared with PBO were somnolence , dizziness , fatigue , influenza , insomnia , nasopharyngitis , vomiting , diarrhea , urinary tract infection , and nausea .
-CONCLUSIONS	Adjunctive BRV at a daily dose of 50 mg was associated with statistically significant reductions in seizure frequency compared with PBO .
-CONCLUSIONS	All doses of BRV showed good tolerability throughout the study .
-
-###25103167
-BACKGROUND	Although several interventions have shown reduced HIV incidence in clinical trials , the community-level effect of effective interventions on the epidemic when scaled up is unknown .
-BACKGROUND	We investigated whether a multicomponent , multilevel social and behavioural prevention strategy could reduce HIV incidence , increase HIV testing , reduce HIV risk behaviour , and change social and behavioural norms .
-METHODS	For this phase 3 cluster-randomised controlled trial , 34 communities in four sites in Africa and 14 communities in Thailand were randomly allocated in matched pairs to receive 36 months of community-based voluntary counselling and testing for HIV ( intervention group ) or standard counselling and testing alone ( control group ) between January , 2001 , and December , 2011 .
-METHODS	The intervention was designed to make testing more accessible in communities , engage communities through outreach , and provide support services after testing .
-METHODS	Randomisation was done by a computer-generated code and was not masked .
-METHODS	Data were collected at baseline ( n = 14 567 ) and after intervention ( n = 56.683 ) by cross-sectional random surveys of community residents aged 18-32 years .
-METHODS	The primary outcome was HIV incidence and was estimated with a cross-sectional multi-assay algorithm and antiretroviral drug screening assay .
-METHODS	Thailand was excluded from incidence analyses because of low HIV prevalence .
-METHODS	This trial is registered at ClinicalTrials.gov , number NCT00203749 .
-RESULTS	The estimated incidence of HIV in the intervention group was 1.52 % versus 1.81 % in the control group with an estimated reduction in HIV incidence of 13.9 % ( relative risk [ RR ] 0.86 , 95 % CI 0.73-1 .02 ; p = 0.082 ) .
-RESULTS	HIV incidence was significantly reduced in women older than 24 years ( RR = 0.70 , 0.54-0 .90 ; p = 0.0085 ) , but not in other age or sex subgroups .
-RESULTS	Community-based voluntary counselling and testing increased testing rates by 25 % overall ( 12-39 ; p = 0.0003 ) , by 45 % ( 25-69 ; p < 00001 ) in men and 15 % ( 3-28 ; p = 0.013 ) in women .
-RESULTS	No overall effect on sexual risk behaviour was recorded .
-RESULTS	Social norms regarding HIV testing were improved by 6 % ( 95 % CI 3-9 ) in communities in the intervention group .
-CONCLUSIONS	These results are sufficiently robust , especially when taking into consideration the combined results of modest reductions in HIV incidence combined with increases in HIV testing and reductions in HIV risk behaviour , to recommend the Project Accept approach as an integral part of all interventions ( including treatment as prevention ) to reduce HIV transmission at the community level .
-BACKGROUND	US National Institute of Mental Health , the Division of AIDS of the US National Institute of Allergy and Infectious Diseases , and the Office of AIDS Research of the US National Institutes of Health .
-
-###25446830
-BACKGROUND	Measles is a highly infectious respiratory disease which causes 122,000 deaths annually .
-BACKGROUND	Although measles vaccine is extremely safe and effective , vaccine coverage could be improved by a vaccine that is more easily administered and transported .
-BACKGROUND	We developed an inhalable dry powder measles vaccine ( MVDP ) and two delivery devices , and demonstrated safety , immunogenicity , and efficacy of the vaccine in preclinical studies .
-BACKGROUND	Here we report the first clinical trial of MVDP delivered by inhalation .
-METHODS	Sixty adult males aged 18 to 45 years , seropositive for measles antibody , were enrolled in this controlled Phase I clinical study .
-METHODS	Subjects were randomly assigned in 1:1:1 ratio to receive either MVDP by Puffhaler ( ) or by Solovent devices or the licensed subcutaneous measles vaccine .
-METHODS	Adverse events ( AEs ) were recorded with diary cards until day 28 post-vaccination and subjects were followed for 180 days post-vaccination to assess potential serious long term adverse events .
-METHODS	Measles antibody was measured 7 days before vaccination and at days 21 and 77 after vaccination by ELISA and a plaque reduction neutralization test .
-RESULTS	All subjects completed the study according to protocol .
-RESULTS	Most subjects had high levels of baseline measles antibody .
-RESULTS	No adverse events were reported .
-RESULTS	MVDP produced serologic responses similar to subcutaneous vaccination .
-CONCLUSIONS	MVDP was well tolerated in all subjects .
-CONCLUSIONS	Most subjects had high baseline measles antibody titer which limited ability to measure the serologic responses , and may have limited the adverse events following vaccination .
-CONCLUSIONS	Additional studies in subjects without pre-existing measles antibody are needed to further elucidate the safety and immunogenicity of MVDP .
-
-###24406474
-OBJECTIVE	To compare the efficacy and tolerability of morning-only polyethylene glycol ( PEG ) with split-dose preparation in hospitalized patients scheduled for colonoscopy .
-BACKGROUND	Morning-only colonoscopy preparation may improve efficiency by allowing patient preparation and colonoscopy to be performed on the same day .
-BACKGROUND	There are limited data comparing morning-only with split-dose preparation , and more studies are needed before morning-only preparation can be routinely recommended .
-METHODS	A single-center , prospective , endoscopist-blinded study was conducted , in which hospitalized patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive 4 L of PEG either on the morning of colonoscopy or as a split-dose ( evening-morning ) .
-METHODS	The primary endpoint was efficacy of bowel preparation measured by the Ottawa scale .
-METHODS	Secondary endpoints were patient compliance and tolerance .
-RESULTS	A total of 120 hospitalized patients scheduled for diagnostic colonoscopy were randomized .
-RESULTS	The mean total Ottawa score was slightly superior for the morning-only arm , and the upper bound of 95 % confidence interval ( CI ) for difference between arms was less than our prespecified noninferiority margin of 1.5 ( difference = -0.23 ; 95 % CI , -1.72 to 1.25 ) .
-RESULTS	The percentage of patients with good bowel preparation was similar for all colonic segments .
-RESULTS	There was a trend toward more side effects among patients in the morning-only compared with the split-dose arm ( 71 % vs. 54 % ; P = 0.08 ) .
-RESULTS	Compared with morning-only preparation , more patients in the split-dose arm were willing to undergo similar preparation for future colonoscopies ( 71 % vs. 89 % ; P = 0.02 ) .
-CONCLUSIONS	Morning-only PEG is not inferior to split-dose preparation regarding bowel cleansing efficacy for colonoscopy in hospitalized patients .
-CONCLUSIONS	However , split-dose preparation was preferred by patients because of less side effects .
-
-###24906392
-BACKGROUND	Caring for a young person experiencing first-episode psychosis is challenging and can affect carers ' well-being adversely .
-BACKGROUND	While some face-to-face approaches have achieved promising outcomes , they are costly and resource-intensive to provide , restricting their reach and penetration .
-BACKGROUND	Guided self-help in book-form ( or bibliotherapy ) is an alternative but untested approach in these circumstances .
-BACKGROUND	In this study , we aimed to evaluate carers ' beliefs about the usefulness of problem-solving guided self-help manual for primary carers of young people with first-episode psychosis .
-METHODS	A qualitative process evaluation nested in a randomised controlled trial , conducted across two early intervention psychosis services in Melbourne , Australia .
-METHODS	124 carers were randomised to problem-solving guided self-help intervention or treatment as usual .
-METHODS	We also undertook a qualitative process evaluation , using individual interviews , with a random sample of 24 of the intervention group .
-METHODS	A thematic analysis of the qualitative data was undertaken , which is the subject of this paper .
-METHODS	Interviews were conducted between January 2009 and September 2010 .
-RESULTS	Three themes were abstracted from the data , reflecting carers ' beliefs about the usefulness of the manual : promoting carers ' well-being , increasing carers ' understanding of and support for the young person with first-episode psychosis , and accessibility and delivery modes of the programme .
-CONCLUSIONS	This process evaluation highlights that guided self-help is useful in informing and supporting carers of affected young people .
-CONCLUSIONS	While there is scope for broadening the delivery modes , the approach is easy to use and accessible , and can be used as a cost-effective adjunct to standard support provided to carers , by community mental health nurses and other clinicians .
-BACKGROUND	ACTRN12609000064202 .
-
-###25520127
-BACKGROUND	Helicobacter pylori ( H. pylori ) remains an important cause of gastric cancer and peptic ulcer disease worldwide .
-BACKGROUND	Treatment of H. pylori infection is one of the effective ways to prevent gastric cancer .
-BACKGROUND	However , standard triple therapy for H. pylori eradication is no longer effective in many countries , including Thailand .
-BACKGROUND	This study was designed to evaluate the efficacy of adding bismuth and probiotic to standard triple therapy for H. pylori eradication .
-METHODS	In this prospective single center study , H. pylori infected gastritis patients were randomized to receive 7 - or 14-day standard triple therapy plus bismuth with probiotic or placebo .
-METHODS	Treatment regimen consisted of 30 mg lansoprazole twice daily , 1 g amoxicillin twice daily , 1 g clarithromycin MR once daily and 1,048 mg bismuth subsalicylate twice daily .
-METHODS	Probiotic bacteria composed of Bifidobacterium lactis , Lactobacillus acidophilus and Lactobacillus paracasei .
-METHODS	Placebo was conventional drinking yogurt without probiotic .
-METHODS	CYP2C19 genotyping and antibiotic susceptibility tests were also done .
-METHODS	H pylori eradication was defined as a negative 13C-urea breath test at least 2 weeks after completion of treatment .
-RESULTS	One hundred subjects were enrolled ( 25 each to 7 - and 14-day regimens with probiotic or placebo ) .
-RESULTS	Antibiotic susceptibility tests showed 36.7 % metronidazole and 1.1 % clarithromycin resistance .
-RESULTS	CYP2C19 genotyping revealed 40.8 % , 49 % and 10.2 % were rapid , intermediate and poor metabolizers , respectively .
-RESULTS	The eradication rates of 7 - or 14 regimens with probiotics were 100 % .
-RESULTS	Regarding adverse events , the incidence of bitter taste was significantly lower in the 7 - day regimen with the probiotic group compared with 7 - day regimen with placebo ( 40 % vs. 64 % ; p = 0.04 ) .
-CONCLUSIONS	The 7-day standard triple therapy plus bismuth and probiotic can provide an excellent cure rate of H. pylori ( 100 % ) in areas with low clarithromycin resistance such as Thailand , regardless of CYP2C19 genotype .
-CONCLUSIONS	Adding a probiotic also reduced treatment-related adverse events .
-
-###25107542
-OBJECTIVE	In an ongoing prospective multicenter randomised placebo-controlled trial we study the adjuvant use of intravitreal dexamethasone in the treatment of patients with suspected bacterial endophthalmitis after phacoemulsification .
-OBJECTIVE	In accordance with the study protocol , a mid-inclusion interim analysis of the safety of the study drug was performed .
-METHODS	Patients with suspected endophthalmitis after phacoemulsification were asked to participate in this study .
-METHODS	A diagnostic vitreous biopsy was taken and the patients received intravitreal injections of 400 micrograms dexamethasone or a placebo , plus 0.2 mg vancomycin and 0.05 mg gentamicin .
-METHODS	Injections were repeated after 3 or 4 days .
-METHODS	The safety analysis included : the number of eyes with an evisceration ; no light perception ; or a visual acuity of less than 5/200 .
-METHODS	Treatment outcome was evaluated in terms of : the percentage of patients with a visual acuity of 20/40 or more and 20/100 or more .
-RESULTS	The interim analysis included 81 patients with at least 1 year follow-up .
-RESULTS	Sixty-three patients ( 65 % ) were culture-positive .
-RESULTS	Safety analysis : 7 eyes were eviscerated ( 3 dexamethasone , 4 placebo ) ; 4 eyes had no light perception ( 2 dexamethasone , 2 placebo ) ; and 4 eyes had less than 5/200 vision ( 3 dexamethasone , 1 placebo ) .
-RESULTS	Treatment outcome : 70 % of patients had a visual acuity of at least 20/40 .
-CONCLUSIONS	The safety analysis does not warrant premature discontinuation of the study .
-CONCLUSIONS	So far , the overall outcome of our treatment regimen , consisting of merely a diagnostic biopsy instead of a vitrectomy and an optimized antibiotic dosing , compares favourably to published literature .
-
-###24953481
-BACKGROUND	Many well-researched treatments for depression exist .
-BACKGROUND	However , there is not yet enough evidence on whether these therapies , designed for the treatment of depression , are also effective for reducing suicidal ideation .
-BACKGROUND	This research provides valuable information for researchers , clinicians , and suicide prevention policy makers .
-METHODS	Analysis was conducted on the Treatment for Depression Research Collaborative ( TDCRP ) sample , which included CBT , IPT , medication , and placebo treatment groups .
-METHODS	Participants were included in the analysis if they reported suicidal ideation on the HRSD or BDI ( score of 1 ) .
-RESULTS	Multivariate linear regression indicated that both IPT ( b = .41 , p < .05 ) and medication ( b = .47 , p < .05 ) yielded a significant reduction in suicide symptoms compared to placebo on the HRSD .
-RESULTS	Multivariate linear regression indicated that after adjustment for change in depression these treatment effects were no longer significant .
-RESULTS	Moderate Cohens d effect sizes from baseline to post-test differences in suicide score by treatment group are reported .
-CONCLUSIONS	These analyses were completed on a single suicide item from each of the measures .
-CONCLUSIONS	Moreover , the TDCRP excluded participants with moderate to severe suicidal ideation .
-CONCLUSIONS	This study demonstrates the specific effectiveness of IPT and medications in reducing suicidal ideation ( relative to placebo ) , albeit largely as a consequence of their more general effects on depression .
-CONCLUSIONS	This adds to the growing body of evidence that depression treatments , specifically IPT and medication , can also reduce suicidal ideation and serves to further our understanding of the complex relationship between depression and suicide .
-
-###24554005
-OBJECTIVE	We aimed to study the relationship between measures of adiposity , insulin sensitivity and N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) in the Diabetes Prevention Program ( DPP ) .
-METHODS	The DPP is a completed clinical trial .
-METHODS	Using stored samples from this resource , we measured BMI , waist circumference ( WC ) , an insulin sensitivity index ( ISI ; [ 1/HOMA-IR ] ) and NT-proBNP at baseline and at 2 years of follow-up in participants randomised to placebo ( n = 692 ) , intensive lifestyle intervention ( n = 832 ) or metformin ( n = 887 ) .
-RESULTS	At baseline , log NT-proBNP did not differ between treatment arms and was correlated with baseline log ISI ( p < 0.0001 ) and WC ( p = 0.0003 ) but not with BMI ( p = 0.39 ) .
-RESULTS	After 2 years of treatment , BMI decreased in the lifestyle and metformin groups ( both p < 0.0001 ) ; WC decreased in all three groups ( p < 0.05 for all ) ; and log ISI increased in the lifestyle and metformin groups ( both p < 0.001 ) .
-RESULTS	The change in log NT-proBNP did not differ in the lifestyle or metformin group vs the placebo group ( p > 0.05 for both ) .
-RESULTS	In regression models , the change in log NT-proBNP was positively associated with the change in log ISI ( p < 0.005 ) in all three study groups after adjusting for changes in BMI and WC , but was not associated with the change in BMI or WC after adjusting for changes in log ISI .
-CONCLUSIONS	Circulating NT-proBNP was associated with a measure of insulin sensitivity before and during preventive interventions for type 2 diabetes in the DPP .
-CONCLUSIONS	This relationship persisted after adjustment for measures of adiposity and was consistent regardless of whether a participant was treated with placebo , intensive lifestyle intervention or metformin .
-
-###24763156
-OBJECTIVE	The aim of this study is to examine the feasibility , efficacy , and safety of a group-based yoga therapy intervention for middle-aged and older women with urinary incontinence .
-METHODS	We conducted a pilot randomized trial of ambulatory women aged 40 years and older with stress , urgency , or mixed-type incontinence .
-METHODS	Women were randomized to a 6-week yoga therapy program ( n = 10 ) consisting of twice weekly group classes and once weekly home practice or a wait-list control group ( n = 9 ) .
-METHODS	All participants also received written pamphlets about standard behavioral self-management strategies for incontinence .
-METHODS	Changes in incontinence were assessed with 7-day voiding diaries .
-RESULTS	The mean ( SD ) age was 61.4 ( 8.2 ) years , and the mean baseline frequency of incontinence was 2.5 ( 1.3 ) episodes/d .
-RESULTS	After 6 weeks , the total incontinence frequency decreased by 70 % ( 1.8 [ 0.9 ] fewer episodes/d ) in the yoga therapy versus 13 % ( 0.3 [ 1.7 ] fewer episodes/d ) in the control group ( P = 0.049 ) .
-RESULTS	Participants in the yoga therapy group also reported an average of 71 % decrease in stress incontinence frequency ( 0.7 [ 0.8 ] fewer episodes/d ) compared with a 25 % increase in controls ( 0.2 [ 1.1 ] more episodes/d ) ( P = 0.039 ) .
-RESULTS	No significant differences in reduction in urgency incontinence were detected between the yoga therapy versus control groups ( 1.0 [ 1.0 ] versus 0.5 [ 0.5 ] fewer episodes/d ; P = 0.20 ) .
-RESULTS	All women starting the yoga therapy program completed at least 90 % of the group classes and practice sessions .
-RESULTS	Two participants in each group reported adverse events unrelated to the intervention .
-CONCLUSIONS	Findings provide preliminary evidence to support the feasibility , efficacy , and safety of a group-based yoga therapy intervention to improve urinary incontinence in women .
-
-###24260145
-OBJECTIVE	The role of genetics for predicting the response to cognitive behavior therapy ( CBT ) for social anxiety disorder ( SAD ) has only been studied in one previous investigation .
-OBJECTIVE	The serotonin transporter ( 5-HTTLPR ) , the catechol-o-methyltransferase ( COMT ) val158met , and the tryptophan hydroxylase-2 ( TPH2 ) G-703T polymorphisms are implicated in the regulation of amygdala reactivity and fear extinction and therefore might be of relevance for CBT outcome .
-OBJECTIVE	The aim of the present study was to investigate if these three gene variants predicted response to CBT in a large sample of SAD patients .
-METHODS	Participants were recruited from two separate randomized controlled CBT trials ( trial 1 : n = 112 , trial 2 : n = 202 ) .
-METHODS	Genotyping were performed on DNA extracted from blood or saliva samples .
-METHODS	Effects were analyzed at follow-up ( 6 or 12 months after treatment ) for both groups and for each group separately at post-treatment .
-METHODS	The main outcome measure was the Liebowitz Social Anxiety Scale Self-Report .
-RESULTS	At long-term follow-up , there was no effect of any genotype , or gene gene interactions , on treatment response .
-RESULTS	In the subsamples , there was time by genotype interaction effects indicating an influence of the TPH2 G-703T-polymorphism on CBT short-term response , however the direction of the effect was not consistent across trials .
-CONCLUSIONS	None of the three gene variants , 5-HTTLPR , COMTval158met and TPH2 G-703T , was associated with long-term response to CBT for SAD .
-BACKGROUND	ClinicalTrials.gov ( ID-NCT0056496 ) .
-
-###24912561
-BACKGROUND	Balance control relies on accurate perception of visual , somatosensory and vestibular cues .
-BACKGROUND	Sensory flow is impaired in Multiple Sclerosis ( MS ) and little is known about the ability of the sensory systems to adapt after neurological lesions reducing sensory impairment .
-BACKGROUND	The aims of the present study were to verify whether : 1 .
-BACKGROUND	Balance rehabilitation administered in a challenging sensory conditions would improve stability in upright posture .
-BACKGROUND	2 .
-BACKGROUND	The improvement in a treated sensory condition would transfer to a non treated sensory condition .
-METHODS	Fifty three persons with MS , median ( min-max ) EDSS score of 5 ( 2.5-6 .5 ) , participated in a RCT and were randomly assigned to two groups .
-METHODS	The Experimental group received balance rehabilitation aimed at improving motor and sensory strategies .
-METHODS	The Control group received rehabilitation treatment which did not include training of sensory strategies .
-METHODS	Persons with MS were blindly assessed by means of a stabilometric platform with eyes open , eyes closed and dome , on both firm surface and foam .
-METHODS	Anterior-posterior and medio-lateral sway , velocity of sway and the length of Center of Pressure ( CoP ) trajectory were calculated in the six sensory conditions .
-RESULTS	Experimental group showed statistically significant improvement ( P < 0.05 ) in stability in upright posture in eyes closed condition on firm surface , and in eyes open , closed , and dome conditions on foam .
-RESULTS	No differences were observed between groups in the eyes open condition on firm surface nor in the sensory condition not addressed during the treatment .
-CONCLUSIONS	After rehabilitation people with MS can recover from sensory impairments thus improving upright balance .
-CONCLUSIONS	Further , the improvement seems to be context-dependent and present just in the treated sensory conditions .
-BACKGROUND	ClinicalTrials NCT02131285 .
-
-###25457733
-OBJECTIVE	To assess the effectiveness of a tailored theory-based , Web-delivered intervention ( Young Adults Eating and Active for Health ) developed using community-based participatory research process .
-METHODS	A 15-month ( 10-week intensive intervention with a 12-month follow-up ) randomized , controlled trial delivered via Internet and e-mail .
-METHODS	Thirteen college campuses .
-METHODS	A total of 1,639 college students .
-METHODS	Twenty-one mini-educational lessons and e-mail messages ( called nudges ) developed with the non-diet approach and focusing on eating behavior , physical activity , stress management , and healthy weight management .
-METHODS	Nudges were short , frequent , entertaining , and stage-tailored to each behavior , and reinforced lesson content .
-METHODS	All participants were assessed at baseline , postintervention ( 3 months from baseline ) , and follow-up ( 15 months from baseline ) for primary outcomes of weight , body mass index ( BMI ) , fruit and vegetable intake ( FVI ) , physical activity ( PA ) , and perceived stress ; and secondary outcomes of waist circumference , percent dietary fat , energy from sugar-sweetened beverages , servings of whole grains , self-instruction and regulation for mealtime behavior , hours of sleep , and stage of readiness for change for consuming 5 cups of FVI , completing 150 minutes of PA/wk , and managing stress on most days of the week .
-METHODS	Demographics were collected at baseline .
-METHODS	Chi-square analysis and mixed-models repeated measures analysis were performed to determine differences between experimental and control outcomes .
-RESULTS	There were no differences between experimental and control participants in BMI , weight , and waist circumference .
-RESULTS	There were small improvements in FVI ( P = .001 ) , vigorous PA in females ( P = .05 ) , fat intake ( P = .002 ) , self-instruction ( P = .001 ) , and regulation ( P = .004 ) for mealtime behavior , and hours of sleep ( P = .05 ) at postintervention , but improvements were not maintained at follow-up .
-RESULTS	At postintervention , a greater proportion of experimental participants were in the action/maintenance stages for FVI ( P = .019 ) and PA ( P = .002 ) than control .
-CONCLUSIONS	Young Adults Eating and Active for Health is one of the first studies to use the community-based participatory research process of PRECEDE-PROCEED to develop a non-diet approach intervention .
-CONCLUSIONS	Although there were no differences between experimental and control participants in weight change or BMI , the intervention supported positive change in behaviors that may mediate excessive weight gain , such as increasing FVI and more healthful self-regulation mealtime behaviors immediately postintervention .
-CONCLUSIONS	Additional strategies to maintain the behavior changes need to be explored .
-
-###24862977
-BACKGROUND	Endothelial dysfunction has been suggested as a potential mechanism by which ambient air pollution may cause acute cardiovascular events .
-BACKGROUND	Recently , plasma nitrite has been developed as a marker of endothelial dysfunction .
-OBJECTIVE	We examined the changes in plasma nitrite concentration associated with increases in ambient air pollutant concentrations in the previous 7 d.
-METHODS	We linked up to three measurements of plasma nitrite concentrations obtained from 49 students to 24-h average concentrations of five criteria air pollutants [ particle mass < 2.5 m in aerodynamic diameter ( PM ( 2.5 ) ) , carbon monoxide ( CO ) , sulfur dioxide ( SO ) , nitrogen dioxide ( NO ) , and ozone ( O ) ] measured at two monitoring sites closest to Rutgers University campus ( 6-15 miles ) in New Jersey during the years 2006-2009 .
-METHODS	We examined the change in plasma nitrite associated with each interquartile-range ( IQR ) increase in pollutant concentration in the previous 24h and six preceding 24-h periods , using linear mixed models .
-RESULTS	IQR increases in mean PM ( 2.5 ) ( 7.0 g/m ) and CO ( 161.7 parts per billion ) concentrations in the first 24h before the plasma nitrite measurement were associated with increased plasma nitrite concentrations ( PM ( 2.5 ) : 15.5 nanomolar ; 95 % confidence interval ( CI ) : 2.4 , 28.5 ; CO : 15.6 nanomolar ; 95 % CI : 2.4 , 28.9 ) .
-RESULTS	Increased plasma nitrite associated with IQR increases in O and SO concentrations over longer lags were observed .
-CONCLUSIONS	Rapid increases in plasma nitrite following exposure to ambient air pollutants support the hypothesis that ambient air pollution is associated with inducible nitric oxide synthase-mediated systemic inflammation in humans .
-
-###25801579
-OBJECTIVE	To compare the effectiveness and acceptability of outpatient polypectomy with inpatient polypectomy .
-METHODS	Pragmatic multicentre randomised controlled non-inferiority study .
-METHODS	Outpatient hysteroscopy clinics in 31 UK National Health Service hospitals .
-METHODS	507 women who attended as outpatients for diagnostic hysteroscopy because of abnormal uterine bleeding and were found to have uterine polyps .
-METHODS	Participants were randomly assigned to either outpatient uterine polypectomy under local anaesthetic or inpatient uterine polypectomy under general anaesthesia .
-METHODS	Data were collected on women 's self reported bleeding symptoms at baseline and at 6 , 12 , and 24 months .
-METHODS	Data were also collected on pain and acceptability of the procedure at the time of polypectomy .
-METHODS	The primary outcome was successful treatment , determined by the women 's assessment of bleeding at six months , with a prespecified non-inferiority margin of 25 % .
-METHODS	Secondary outcomes included generic ( EQ-5D ) and disease specific ( menorrhagia multi-attribute scale ) quality of life , and feasibility and acceptability of the procedure .
-RESULTS	73 % ( 166/228 ) of women in the outpatient group and 80 % ( 168/211 ) in the inpatient group reported successful treatment at six months ( intention to treat relative risk 0.91 , 95 % confidence interval 0.82 to 1.02 ; per protocol relative risk 0.92 , 0.82 to 1.02 ) .
-RESULTS	Failure to remove polyps was higher ( 19 % v 7 % ; relative risk 2.5 , 1.5 to 4.1 ) and acceptability of the procedure was lower ( 83 % v 92 % ; 0.90 , 0.84 to 0.97 ) in the outpatient group Quality of life did not differ significantly between the groups .
-RESULTS	Four uterine perforations , one of which necessitated bowel resection , all occurred in the inpatient group .
-CONCLUSIONS	Outpatient polypectomy was non-inferior to inpatient polypectomy .
-CONCLUSIONS	Failure to remove a uterine polyp was , however , more likely with outpatient polypectomy and acceptability of the procedure was slightly lower .
-BACKGROUND	International Clinical Trials Registry 65868569 .
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-###24786143
-BACKGROUND	Observational studies have raised concerns that high-potency statins increase the risk of acute kidney injury .
-BACKGROUND	We therefore examined the incidence of kidney injury across 2 randomized trials of statin therapy .
-RESULTS	PROVE IT-TIMI 22 enrolled 4162 subjects after an acute coronary syndrome ( ACS ) and randomized them to atorvastatin 80 mg/day versus pravastatin 40 mg/day .
-RESULTS	A-to-Z enrolled 4497 subjects after ACS and randomized them to a high-potency ( simvastatin 40 mg/day 1 months , then simvastatin 80 mg/day ) versus a delayed moderate-potency statin strategy ( placebo 4 months , then simvastatin 20 mg/day ) .
-RESULTS	Serum creatinine was assessed centrally at serial time points .
-RESULTS	Adverse events ( AEs ) relating to kidney injury were identified through database review .
-RESULTS	Across both trials , mean serum creatinine was similar between treatment arms at baseline and throughout follow-up .
-RESULTS	In A-to-Z , the incidence of a 1.5-fold or 0.3 mg/dL rise in serum creatinine was 11.4 % for subjects randomized to a high-potency statin regimen versus 12.4 % for those on a delayed moderate-potency regimen ( odds ratio [ OR ] , 0.91 ; 95 % confidence interval [ CI ] , 0.76 to 1.10 ; P = 0.33 ) .
-RESULTS	In PROVE IT-TIMI 22 , the incidence was 9.4 % for subjects randomized to atorvastatin 80 mg/day and 10.6 % for subjects randomized to pravastatin 40 mg/day ( OR , 0.88 ; 95 % CI , 0.71 to 1.09 ; P = 0.25 ) .
-RESULTS	Consistent results were observed for different kidney injury thresholds and in individuals with diabetes mellitus or with moderate renal dysfunction .
-RESULTS	The incidence of kidney injury-related adverse events ( AEs ) was not statistically different for patients on a high-potency versus moderate-potency statin regimen ( OR , 1.06 ; 95 % CI , 0.68 to 1.67 ; P = 0.78 ) .
-CONCLUSIONS	For patients enrolled in 2 large randomized trials of statin therapy after ACS , the use of a high-potency statin regimen did not increase the risk of kidney injury .
-
-###25320361
-OBJECTIVE	Myeloid-derived suppressor cells ( MDSC ) and regulatory T cells ( Treg ) play a key role in the progression of head and neck squamous cell carcinoma ( HNSCC ) .
-OBJECTIVE	On the basis of our preclinical data demonstrating that phosphodiesterase-5 ( PDE5 ) inhibition can modulate these cell populations , we evaluated whether the PDE5 inhibitor tadalafil can revert tumor-induced immunosuppression and promote tumor immunity in patients with HNSCC .
-METHODS	First , we functionally and phenotypically characterized MDSCs in HNSCCs and determined , retrospectively , whether their presence at the tumor site correlates with recurrence .
-METHODS	Then , we performed a prospective single-center , double-blinded , randomized , three-arm study in which patients with HNSCC undergoing definitive surgical resection of oral and oropharyngeal tumors were treated with tadalafil 10 mg/day , 20 mg/day , or placebo for at least 20 days preoperatively .
-METHODS	Blood and tumor MDSC and Treg presence and CD8 ( + ) T-cell reactivity to tumor antigens were evaluated before and after treatment .
-RESULTS	MDSCs were characterized in HNSCC and their intratumoral presence significantly correlates with recurrence .
-RESULTS	Tadalafil treatment was well tolerated and significantly reduced both MDSCs and Treg concentrations in the blood and in the tumor ( P < 0.05 ) .
-RESULTS	In addition , the concentration of blood CD8 ( + ) T cells reactive to autologous tumor antigens significantly increased after treatment ( P < 0.05 ) .
-RESULTS	Tadalafil immunomodulatory activity was maximized at an intermediate dose but not at higher doses .
-RESULTS	Mechanistic analysis suggests a possible off-target effect on PDE11 at high dosages that , by increasing intracellular cAMP , may negatively affect antitumor immunity .
-CONCLUSIONS	Tadalafil seems to beneficially modulate the tumor micro - and macro-environment in patients with HNSCC by lowering MDSCs and Tregs and increasing tumor-specific CD8 ( + ) T cells in a dose-dependent fashion .
-
-###24858921
-BACKGROUND	Tafazzin ( TAZ ) , a transmembrane protein contributes in mitochondrial structural and functional modifications through cardiolipin remodeling .
-BACKGROUND	TAZ mutations are associated with several diseases , but studies on the role of TAZ protein in carcinogenesis and radiotherapy ( RT ) response is lacking .
-BACKGROUND	Therefore we investigated the TAZ expression in rectal cancer , and its correlation with RT , clinicopathological and biological variables in the patients participating in a clinical trial of preoperative RT. .
-METHODS	140 rectal cancer patients were included in this study , of which 65 received RT before surgery and the rest underwent surgery alone .
-METHODS	TAZ expression was determined by immunohistochemistry in primary cancer , distant , adjacent normal mucosa and lymph node metastasis .
-METHODS	In-silico protein-protein interaction analysis was performed to study the predictive functional interaction of TAZ with other oncoproteins .
-RESULTS	TAZ showed stronger expression in primary cancer and lymph node metastasis compared to distant or adjacent normal mucosa in both non-RT and RT patients .
-RESULTS	Strong TAZ expression was significantly higher in stages I-III and non-mucinious cancer of non-RT patients .
-RESULTS	In RT patients , strong TAZ expression in biopsy was related to distant recurrence , independent of gender , age , stages and grade ( p = 0.043 , HR , 6.160 , 95 % CI , 1.063-35 .704 ) .
-RESULTS	In silico protein-protein interaction study demonstrated that TAZ was positively related to oncoproteins , Livin , MAC30 and FXYD-3 .
-CONCLUSIONS	Strong expression of TAZ protein seems to be related to rectal cancer development and RT response , it can be a predictive biomarker of distant recurrence in patients with preoperative RT. .
-
-###25773268
-BACKGROUND	The potential benefit of dual antiplatelet therapy beyond 1 year after a myocardial infarction has not been established .
-BACKGROUND	We investigated the efficacy and safety of ticagrelor , a P2Y12 receptor antagonist with established efficacy after an acute coronary syndrome , in this context .
-METHODS	We randomly assigned , in a double-blind 1:1:1 fashion , 21,162 patients who had had a myocardial infarction 1 to 3 years earlier to ticagrelor at a dose of 90 mg twice daily , ticagrelor at a dose of 60 mg twice daily , or placebo .
-METHODS	All the patients were to receive low-dose aspirin and were followed for a median of 33 months .
-METHODS	The primary efficacy end point was the composite of cardiovascular death , myocardial infarction , or stroke .
-METHODS	The primary safety end point was Thrombolysis in Myocardial Infarction ( TIMI ) major bleeding .
-RESULTS	The two ticagrelor doses each reduced , as compared with placebo , the rate of the primary efficacy end point , with Kaplan-Meier rates at 3 years of 7.85 % in the group that received 90 mg of ticagrelor twice daily , 7.77 % in the group that received 60 mg of ticagrelor twice daily , and 9.04 % in the placebo group ( hazard ratio for 90 mg of ticagrelor vs. placebo , 0.85 ; 95 % confidence interval [ CI ] , 0.75 to 0.96 ; P = 0.008 ; hazard ratio for 60 mg of ticagrelor vs. placebo , 0.84 ; 95 % CI , 0.74 to 0.95 ; P = 0.004 ) .
-RESULTS	Rates of TIMI major bleeding were higher with ticagrelor ( 2.60 % with 90 mg and 2.30 % with 60 mg ) than with placebo ( 1.06 % ) ( P < 0.001 for each dose vs. placebo ) ; the rates of intracranial hemorrhage or fatal bleeding in the three groups were 0.63 % , 0.71 % , and 0.60 % , respectively .
-CONCLUSIONS	In patients with a myocardial infarction more than 1 year previously , treatment with ticagrelor significantly reduced the risk of cardiovascular death , myocardial infarction , or stroke and increased the risk of major bleeding .
-CONCLUSIONS	( Funded by AstraZeneca ; PEGASUS-TIMI 54 ClinicalTrials.gov number , NCT01225562 . )
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-###24930478
-BACKGROUND	To impact on the obesity epidemic , interventions that prevent weight gain across populations are urgently needed .
-BACKGROUND	However , even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings .
-BACKGROUND	Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle .
-BACKGROUND	Despite the recognised need , few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities .
-METHODS	Here we describe the rationale , design and implementation of a Healthy Lifestyle Program for women living in small rural communities ( HeLP-her Rural ) .
-METHODS	The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity , self-management intervention .
-METHODS	Six hundred women from 42 small rural communities in Australia will be randomised as clusters ( n-21 control towns and n = 21 intervention towns ) .
-METHODS	A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program .
-CONCLUSIONS	Implementing population interventions to prevent obesity is complex , costly and challenging .
-CONCLUSIONS	To address these barriers , evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation .
-CONCLUSIONS	Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level .
-CONCLUSIONS	Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level .
-CONCLUSIONS	The learnings from this trial will impact on the design and implementation of population obesity prevention strategies nationally and internationally .
-BACKGROUND	ANZ clinical trial registry ACTRN12612000115831 .
-BACKGROUND	Date of registration 24/01/2012 .
-
-###24625546
-OBJECTIVE	To assess the efficacy of high-frequency ( 20 Hz ) brain stimulation on lower limb motor function in subjects with chronic ( > 6 mo ) subcortical stroke .
-METHODS	Double-blind , placebo-controlled crossover study .
-METHODS	University hospital .
-METHODS	Right-handed subjects ( N = 10 ) affected by a first-ever subcortical stroke in the territory of the middle cerebral artery were included in this study .
-METHODS	Repetitive transcranial magnetic stimulation ( rTMS ) was delivered with the H-coil , specifically designed to target deeper and larger brains regions .
-METHODS	Each subject received both real and sham rTMS in a random sequence .
-METHODS	The 2 rTMS cycles ( real or sham ) were composed of 11 sessions each , administered over 3 weeks and separated by a 4-week washout period .
-METHODS	Lower limb functions were assessed by the lower limb Fugl-Meyer scale , the 10-m walk test , and the 6-minute walk test before and 1 day after the end of each treatment period , as well as at a 4-week follow-up .
-RESULTS	Real rTMS treatment was associated with a significant improvement in lower limb motor function .
-RESULTS	This effect persisted over time ( follow-up ) and was significantly greater than that observed with sham stimulation .
-RESULTS	A significant increase in walking speed was also found after real rTMS , but this effect did not reach statistical significance in comparison with the sham stimulation .
-CONCLUSIONS	These data demonstrated that 3 weeks of high-frequency deep rTMS could induce long-term improvements in lower limb functions in the chronic poststroke period , lasting at least 1 month after the end of the treatment .
-
-###24368400
-BACKGROUND	Preclinical data suggest combining a mammalian target of rapamycin inhibitor with erlotinib could provide synergistic antitumor effects in advanced non-small-cell lung cancer ( NSCLC ) .
-METHODS	In this multicenter , open-label , phase II study , patients with advanced NSCLC that progressed after one to two previous chemotherapy regimens were randomized 1:1 to erlotinib 150 mg/dayeverolimus 5 mg/day .
-METHODS	Primary end point was the disease control rate ( DCR ) at 3 months ; secondary end points included progression-free survival ( PFS ) and safety .
-RESULTS	One hundred thirty-three patients received everolimus-erlotinib ( n = 66 ) or erlotinib alone ( n = 67 ) .
-RESULTS	The DCR at 3 months was 39.4 % and 28.4 % , respectively .
-RESULTS	The probability for the difference in disease control at 3 months to be 15 % was estimated to be 29.8 % , which was below the prespecified probability threshold of 40 % .
-RESULTS	Median PFS was 2.9 and 2.0 months , respectively .
-RESULTS	Grade 3/4 adverse events occurred in 72.7 % and 32.3 % of patients , respectively .
-RESULTS	Grade 3/4 stomatitis was observed in 31.8 % of combination therapy recipients .
-CONCLUSIONS	Everolimus 5 mg/day plus erlotinib 150 mg/day was not considered sufficiently efficacious per the predefined study criteria .
-CONCLUSIONS	The combination does not warrant further investigation based on increased toxicity and the lack of substantial improvement in disease stabilization .
-
-###25282112
-BACKGROUND	Some pregnancy complications are characterized by increased levels of cell-free fetal ( cffDNA ) and maternal DNA ( cfmDNA ) , the latter may also be elevated during physical strain .
-BACKGROUND	This study aims at assessing the impact of exercise and metformin intervention in pregnancy , and to compare the levels of cell free DNA in pregnant women with or without PCOS diagnosis .
-METHODS	Consecutive women from two previous randomized controlled trials in pregnancy were included .
-METHODS	Women came from a trial with organized exercise vs. standard antenatal care in pregnancy and a trial of metformin vs. placebo in PCOS women .
-METHODS	Levels of cffDNA , cfmDNA and cell-free total DNA ( cftDNA ) were measured by qPCR .
-RESULTS	Training in pregnancy did not affect the levels of cffDNA , cfmDNA or cftDNA .
-RESULTS	PCOS-women treated with metformin had lower levels of cfmDNA and cftDNA at week 32 ( mean SD : 301 162 versus 570 337 , p = 0.012 , 345 173 versus 635 370 , p = 0.019 ) ; otherwise the levels were comparable to PCOS-controls .
-RESULTS	Metformin-treated PCOS-women had higher cffDNA at inclusion , in the 1st trimester ; later on in pregnancy the levels in the metformin and placebo groups were equal .
-RESULTS	A comparison of pregnant women in the exercise study ( TRIP ) to placebo-treated pregnant PCOS-women , showed the levels of cffDNA , cfmDNA or cftDNA during mid-pregnancy ( weeks 18-36 ) to be equal .
-CONCLUSIONS	Training during pregnancy was not associated with altered levels of cffDNA cfmDNA or cftDNA , but metformin treatment may reduce cfmDNA and cftDNA in pregnant PCOS women .
-
-###25995282
-BACKGROUND	Data concerning the effects of afternoon snacking on ingestive behavior , mood , and cognition are limited .
-OBJECTIVE	The purpose of this study was to compare 1088 kJ of high-protein ( HP ) or high-fat ( HF ) afternoon snacks vs. no snacking on appetite , food intake , mood , and cognition in adolescents .
-METHODS	Thirty-one healthy adolescents ( age : 17 1 y ) consumed the following afternoon snacks ( in randomized order ) for 3 d : HP snack ( 26 g of protein/6 g of fat per 27 g of carbohydrates ) , HF snack ( 4 g of protein/12 g of fat per 32 g of carbohydrates ) , and no snack ( NoS ) .
-METHODS	On day 4 of each treatment , the participants completed an 8-h testing day containing pre - and postsnack appetite questionnaires , food cue-stimulated functional MRI brain scans , mood , cognitive function , and eating initiation .
-METHODS	Ad libitum dinner and evening snacks were provided and assessed .
-RESULTS	HP , but not HF , delayed eating initiation vs. NoS ( P < 0.05 ) .
-RESULTS	Both snacks reduced appetite vs. NoS ( P < 0.001 ) with HP eliciting greater reductions than HF ( P < 0.05 ) .
-RESULTS	Only HF led to reductions in corticolimbic activation in brain regions controlling food motivation/reward vs. NoS ( P < 0.01 ) .
-RESULTS	Although no treatment differences in daily energy intake were detected , HP led to greater protein consumption than NoS ( P < 0.05 ) and greater protein and lower fat consumption than HF ( both , P < 0.05 ) .
-RESULTS	HP led to fewer HF/high-sugar evening snacks than NoS ( P < 0.01 ) and HF ( P = 0.09 ) .
-RESULTS	Although no treatment effects were detected for mood and cognition , HP tended to reduce confusion-bewilderment ( P = 0.07 ) and increase cognitive flexibility ( P = 0.09 ) , whereas NoS reduced tension-anxiety ( P < 0.05 ) and vigor-activity ( P < 0.05 ) .
-CONCLUSIONS	Afternoon snacking , particularly on HP soy foods , improves appetite , satiety , and diet quality in adolescents , while beneficially influencing aspects of mood and cognition .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01781286 .
-
-###25720723
-BACKGROUND	Phlebotropic activity , protective effect on the capillaries and anti-inflammatory properties of the Flavonoids have been reported in literature .
-BACKGROUND	Recently , we evaluated the effect of these drugs in controlling postoperative symptoms of proctologic surgery .
-BACKGROUND	In this randomized study we compared the results obtained in two groups of patients , with grade II haemorrhoids , submitted to radiofrequency coagulation of the hemorrhoidal nodule with radiofrequency scalpel ( CHR ) , to verify the effects of Flavonoids to reduce further symptoms after treatment .
-METHODS	Out of 70 patients initially randomized , a total of 59 patients regularly returned to outpatient visit at least for 1 month of follow-up .
-METHODS	Consequently , two groups of patients were considered : Group A , represented by 28 individuals treated with Flavonoids , and Group B , consisting of 31 patients as a control group .
-METHODS	Our purpose was to determine : grade of pain after procedure and at first evacuation ( score from 1 to 10 ) , bleeding , incidence of failures and complications , patient 's satisfaction after 30 days from the treatment ( score from 1 to 10 ) .
-RESULTS	We observed that the results obtained regarding the pain reported at the end of procedures ( 2.51 1.4 for group A and 2.54 1.15 for group B ) and at the first evacuation ( 2.6 .1.52 for group A and 2.7 1.18 for group B ) are similar in both study groups .
-RESULTS	Instead , the mean score on overall satisfaction at 30 days from the treatment showed a statistical significance ( 8.32 1.72 for group A and 6.64 1.78 for group B ; p < 0.05 ) .
-RESULTS	There were no reported other important issues .
-CONCLUSIONS	Our results confirm the usefulness of Flavonoids to make more comfortable the post-treatment period .
-
-###25516879
-OBJECTIVE	To investigate the clinical performance of a silorane-based composite resin used for repairing dimethacrylate - based composite restorations .
-METHODS	One operator repaired defective dimethacrylate-based resin restorations that were randomly assigned to one of two treatment groups : control ( n = 50 ) , repaired with Adper SE Plus and Filtek P60 Posterior Restorative ( 3M ESPE ) ; or test ( n = 50 ) , repaired with P90 System Adhesive Self-Etch Primer and Bond and Filtek P90 Low Shrink Posterior Restorative ( 3M ESPE ) .
-METHODS	After 1 week , restorations were finished and polished .
-METHODS	Two calibrated examiners ( weighted Kappa0 .78 ) evaluated the repaired restorations , blindly and independently , at baseline , after 6 months , 1 and 2 years .
-METHODS	The parameters examined were marginal adaptation , anatomic form , surface roughness , marginal discoloration , postoperative sensitivity , and secondary caries .
-METHODS	The restorations were classified as Alfa , Bravo , or Charlie , according to modified US Public Health Service criteria .
-METHODS	Variation in the levels of clinical parameters over time was evaluated by Friedman 's ANOVA ( = 0.05 ) .
-METHODS	The Mann-Whitney test assessed the differences between the materials for all clinical criteria at baseline , 6-month , 1 - and 2-year recalls ( = 0.05 ) .
-METHODS	The Wilcoxon test compared each composite resin for all clinical criteria at the same recalls ( = 0.05 ) .
-RESULTS	After two years , 79 repaired restorations were re-examined .
-RESULTS	No statistically significant differences were found between the materials at baseline or at the 2-year recall ( p > 0.05 ) .
-RESULTS	Comparing baseline and 2-year recall , there was a statistically significant difference for marginal discoloration ( p = 0.029 ) in silorane-based composite restorations .
-CONCLUSIONS	After two years , the clinical performance of the silorane-based composite was similar to that of the dimethacrylate-based composite when used to make repairs .
-
-###25618118
-BACKGROUND	Neuropsychological and neurological deficits are still major causes of mortality and morbidity after cardiac surgery .
-BACKGROUND	These complications are thought to be caused by embolisms and cerebral hypoxia .
-BACKGROUND	Thus , continuous neuromonitoring is essential during cardiac surgery due to cerebral oxygen desaturation during different periods .
-BACKGROUND	Near-infrared spectrophotometry ( NIRS ) , anon-invasive method , appears to offer many advantages for monitoring cerebral oxygenation and hemodynamics .
-BACKGROUND	Desaturation of cerebral oxygen may occur at the beginning of cardiopulmonary bypass ( CPB ) or during the low perfusion and rewarming stages if not corrected .
-OBJECTIVE	This study was designed to assess the effects of sevoflurane on cerebral protection during CPB .
-METHODS	Eighty patients were divided into two groups .
-METHODS	Anesthesia was maintained either with fentanyl and midazolam ( total intravenous anesthesia , TIVA ) or with one minimum alveolar concentration of sevoflurane and fentanyl .
-METHODS	Cerebral desaturation was defined as an absolute decrease in saturation of 20 % from baseline cerebral saturation .
-METHODS	When desaturation occurred , PaCO2 , hematocrit and PaO2 levels were checked and corrected .
-METHODS	If desaturation continued , anesthetic depth was increased to reserve saturation with 50-100mg of propofol .
-METHODS	NIRS values and hemodynamics were recorded at predetermined time intervals .
-RESULTS	Cerebral oxygen saturation values on the right side were higher in the sevoflurane group than in the TIVA group .
-RESULTS	The values on the left side were higher in the sevoflurane group than in the TIVA group , and meaningful differences were seen at the lowest temperature and at 36C .
-CONCLUSIONS	Oxygen saturation was higher in the sevoflurane group than in the TIVA group .
-CONCLUSIONS	Thus , the effect of sevoflurane was useful for maintaining cerebral oxygen saturation during CBP .
-
-###24578358
-OBJECTIVE	Moderate alcohol consumption has been associated with a reduced risk of mortality and coronary artery disease .
-OBJECTIVE	The relationship between cardiovascular health and alcohol use in type 2 diabetes is less clear .
-OBJECTIVE	The current study assesses the effects of alcohol use among participants in the Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified-Release Controlled Evaluation ( ADVANCE ) trial .
-METHODS	The effects of alcohol use were explored using Cox regression models , adjusted for potential confounders .
-METHODS	The study end points were cardiovascular events ( cardiovascular death , myocardial infarction , and stroke ) , microvascular complications ( new or worsening nephropathy or retinopathy ) , and all-cause mortality .
-RESULTS	During a median of 5 years of follow-up , 1,031 ( 9 % ) patients died , 1,147 ( 10 % ) experienced a cardiovascular event , and 1,136 ( 10 % ) experienced a microvascular complication .
-RESULTS	Compared with patients who reported no alcohol consumption , those who reported moderate consumption had fewer cardiovascular events ( adjusted hazard ratio [ aHR ] 0.83 ; 95 % CI 0.72-0 .95 ; P = 0.008 ) , less microvascular complications ( aHR 0.85 ; 95 % CI 0.73-0 .99 ; P = 0.03 ) , and lower all-cause mortality ( aHR 0.87 ; 96 % CI 0.75-1 .00 ; P = 0.05 ) .
-RESULTS	The benefits were particularly evident in participants who drank predominantly wine ( cardiovascular events aHR 0.78 , 95 % CI 0.63-0 .95 , P = 0.01 ; all-cause mortality aHR 0.77 , 95 % CI 0.62-0 .95 , P = 0.02 ) .
-RESULTS	Compared with patients who reported no alcohol consumption , those who reported heavy consumption had dose-dependent higher risks of cardiovascular events and all-cause mortality .
-CONCLUSIONS	In patients with type 2 diabetes , moderate alcohol use , particularly wine consumption , is associated with reduced risks of cardiovascular events and all-cause mortality .
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-###24281776
-BACKGROUND	Split-thickness skin graft ( STSG ) donor sites sometimes cause more postoperative morbidity for patients than the wound covered with the graft .
-BACKGROUND	Yet , there is no consensus on which dressings are best suited to treat these donor sites .
-OBJECTIVE	To evaluate two commonly used modern wound dressings in the postoperative healing of STSG donor sites in a prospective randomized controlled trial .
-METHODS	38 patients were randomly assigned to treatment of an STSG donor site with an alginate dressing or a polyurethane film dressing .
-METHODS	The primary outcome measures were postoperative pain scores , secondary outcome variables were time to epithelialization , dressing changes and complications .
-RESULTS	Postoperative pain on day 1 was significantly lower in the polyurethane film group ( 2.05 vs. 0.79 , p = 0.035 ) as compared to the alginate group .
-RESULTS	This difference was not detected on day 5 ( 0.89 vs. 0.53 , p = 0.52 ) .
-RESULTS	Time to epithelialization did not differ significantly between the two dressing groups .
-RESULTS	There were more dressing changes in the polyurethane film group and problems with leakage .
-CONCLUSIONS	Whereas film dressings resulted in initially lower pain scores , alginate dressings caused fewer additional dressing changes and less leakage .
-
-###25381468
-OBJECTIVE	Multiple techniques and implants are available for all-inside meniscal repair , but the knowledge about their failure rates and functional outcome is still incomplete .
-OBJECTIVE	The hypothesis was that there might be differences between meniscal arrows and suture devices regarding reoperation rates and functional outcome .
-OBJECTIVE	Thereby , the aim of this study was to compare clinical results following repair with the Biofix ( ) arrows or the FasT-Fix ( ) suture devices .
-METHODS	In this RCT , 46 patients were treated either by Biofix ( ) ( n = 21 ) or FasT-Fix ( ) ( n = 25 ) .
-METHODS	The main outcome was reoperation within 2 years .
-METHODS	Knee function and activity level were evaluated by KOOS and Tegner activity scale .
-RESULTS	Twelve out of 46 ( 26 % ) patients were reoperated within 2 years , nine out of 21 ( 43 % ) in the Biofix ( ) - group versus three out of 25 ( 12 % ) in the FasT-Fix ( ) - group ( p = 0.018 ) .
-RESULTS	The relative risk of reoperation was 3.6 times higher for Biofix ( ) compared to FasT-Fix ( ) ( 95 % confidence interval 1.1-11 .5 ) .
-RESULTS	Both treatment groups had significant increase in all KOOS subscales , but there were no major differences between the groups .
-RESULTS	The subgroup of reoperated patients differed from the other patients with higher Tegner score preoperatively ( median 5 vs. 4 ) ( p = 0.037 ) and at 3-month follow-up ( median 4 vs. 3 ) ( p = 0.010 ) .
-CONCLUSIONS	These results indicate that FasT-Fix ( ) suture is superior to Biofix ( ) arrows with significant lower failure rate .
-CONCLUSIONS	Functional outcome did not depend on repair technique .
-CONCLUSIONS	Higher activity score preoperatively and at 3-month follow-up in the reoperated patients indicates that activity level may influence on the risk of reoperation .
-METHODS	I.
-
-###24679400
-BACKGROUND	Antidepressant medication ( ADM ) is thought to reduce depressive symptoms by altering emotion-generative brain systems .
-BACKGROUND	However , it is unknown whether successful ADM treatment is associated with changes in psychobehavioral strategies used to regulate emotions .
-BACKGROUND	We examined depressive symptoms and emotion regulation strategies before and after ADM in the international Study to Predict Optimized Treatment in Depression ( iSPOT-D ) .
-METHODS	The study enrolled 1008 adult patients with MDD ( 18-65 years old ) from 18 primary and psychiatric care sites worldwide .
-METHODS	Patients were randomly assigned to an 8-week course of escitalopram , sertraline , or venlafaxine-extended-release .
-METHODS	We examined whether ADM is associated with changes in suppression , usually associated with maladaptive outcomes , and reappraisal , usually associated with adaptive outcomes .
-METHODS	We also tested whether changes in emotion regulation predict changes in depressive symptoms following ADM.
-RESULTS	We observed more adaptive emotion regulation ( decreased use of suppression and increased use of reappraisal ) following ADM. Furthermore , the largest improvements in emotion regulation were associated with the best treatment outcomes .
-CONCLUSIONS	Because we assessed acute outcomes , it is not yet known if the effects of ADM on emotion regulation would persist over time .
-CONCLUSIONS	ADMs are associated with acute , adaptive changes in the psychobehavioral strategies used to regulate emotions .
-
-###25403147
-BACKGROUND	Interpretation of double-blind placebo-controlled food challenges ( DBPCFC ) can be difficult , particularly with ambiguous subjective symptoms .
-BACKGROUND	Early opening of the challenge key ( which day is verum and which placebo ) may influence the clinician 's interpretation of the DBPCFC result .
-METHODS	Fifty-one clinicians reviewing results of 19 DBPCFCs with ambiguous clinical symptoms were randomized into a key first strategy ( opening the DBPCFC key before reviewing the symptoms on both challenge days and deciding on the DBPCFC result ) or a symptoms first strategy ( reviewing symptoms and interpreting both test days as positive or negative before opening the key and deciding on the DBPCFC result ) .
-RESULTS	The proportion of DBPCFCs considered inconclusive was comparable between the two strategy groups ( p = 0.791 ) .
-RESULTS	Participants in the symptoms first group were more likely to consider a DBPCFC as positive ( in 14 tests , 73.7 % ) than subjects in the key first group ( four tests , 21.1 % ) .
-RESULTS	The number of positive tests was higher in the symptoms first group ( median 50.0 % , interquartile range [ IQR ] 23.1-76 .9 % ) than in the key first groups ( 44.0 % , IQR 12.0-68 .0 % , p = 0.031 ) .
-RESULTS	This was independent of the participant 's profession ( pediatrician or other ) , age , gender , or years of experience ( p > 0.3 ) .
-CONCLUSIONS	Clinicians differ in their interpretation of DBPCFC results when symptoms are ambiguous .
-CONCLUSIONS	Opening the key of a DBPCFC before reviewing and interpreting symptoms significantly reduces the likelihood of the challenge being interpreted as positive .
-CONCLUSIONS	Guidelines for performing DBPCFCs should standardize the moment of opening the challenge key .
-
-###25460263
-OBJECTIVE	The bivalent fear of evaluation ( BFOE ) model suggests that fears of negative evaluation ( FNE ) and positive evaluation ( FPE ) are distinct features in social anxiety disorder as well as in non-clinical variations of social anxiety .
-OBJECTIVE	The constructs can be measured utilizing the Brief Fear of Negative Evaluation Scale Revised ( BFNE-R ) and the Fear of Positive Evaluation Scale ( FPES ) , respectively .
-OBJECTIVE	Whereas the distinction between FNE and FPE has been well examined in survey studies , concomitant evidence from laboratory tasks is scarce .
-METHODS	The present study tested whether subjective unpleasantness responses to short films simulating positive and negative evaluation from others are related to individual differences in FNE and FPE .
-METHODS	Ninety-eight unselected individuals watched 24 short films displaying actors expressing positive , negative and neutral sentences and rated their responses on unpleasantness .
-METHODS	Furthermore , pride responses to positive films were examined since these can be expected to discriminate between FPE and FNE .
-RESULTS	As expected , higher BFNE-R scores were related to more unpleasant responding to negative films , whereas higher FPES scores were related to more unpleasant responding to positive films .
-RESULTS	Furthermore , experience of pride following positive films correlated positively with BFNE-R , but negatively with FPES scores .
-CONCLUSIONS	Participants were university students which limits representativeness .
-CONCLUSIONS	The study revealed that measures of FNE and FPE show distinct relationships with positive and negative social feedback which provides further evidence for the BFOE model in a laboratory setting .
-
-###26151264
-OBJECTIVE	The optimal duration of anticoagulation after a first episode of unprovoked pulmonary embolism is uncertain .
-OBJECTIVE	To determine the benefits and harms of an additional 18-month treatment with warfarin vs placebo , after an initial 6-month nonrandomized treatment period on a vitamin K antagonist .
-METHODS	Randomized , double-blind trial ( treatment period , 18 months ; median follow-up , 24 months ) ; 371 adult patients who had experienced a first episode of symptomatic unprovoked pulmonary embolism ( ie , with no major risk factor for thrombosis ) and had been treated initially for 6 uninterrupted months with a vitamin K antagonist were randomized and followed up between July 2007 and September 2014 in 14 French centers .
-METHODS	Warfarin or placebo for 18 months .
-METHODS	The primary outcome was the composite of recurrent venous thromboembolism or major bleeding at 18 months after randomization .
-METHODS	Secondary outcomes were the composite at 42 months ( treatment period plus 24-month follow-up ) , as well as each component of the composite , and death unrelated to pulmonary embolism or major bleeding , at 18 and 42 months .
-RESULTS	After randomization , 4 patients were lost to follow-up , all after month 18 , and 1 withdrew due to an adverse event .
-RESULTS	During the 18-month treatment period , the primary outcome occurred in 6 of 184 patients ( 3.3 % ) in the warfarin group and in 25 of 187 ( 13.5 % ) in the placebo group ( hazard ratio [ HR ] , 0.22 ; 95 % CI , 0.09-0 .55 ; P = .001 ) .
-RESULTS	Recurrent venous thromboembolism occurred in 3 patients in the warfarin group and 25 patients in the placebo group ( HR , 0.15 ; 95 % CI , 0.05-0 .43 ) ; major bleeding occurred in 4 patients in the warfarin group and in 1 patient in the placebo group ( HR , 3.96 ; 95 % CI , 0.44 to 35.89 ) .
-RESULTS	During the 42-month entire study period ( including the study treatment and follow-up periods ) , the composite outcome occurred in 33 patients ( 20.8 % ) in the warfarin group and in 42 ( 24.0 % ) in the placebo group ( HR , 0.75 ; 95 % CI , 0.47-1 .18 ) .
-RESULTS	Rates of recurrent venous thromboembolism , major bleeding , and unrelated death did not differ between groups .
-CONCLUSIONS	Among patients with a first episode of unprovoked pulmonary embolism who received 6 months of anticoagulant treatment , an additional 18 months of treatment with warfarin reduced the composite outcome of recurrent venous thrombosis and major bleeding compared with placebo .
-CONCLUSIONS	However , benefit was not maintained after discontinuation of anticoagulation therapy .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00740883 .
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-###25493970
-OBJECTIVE	Use of antibiotics in critically ill patients may increase the risk of invasive Candida infection .
-OBJECTIVE	The objective of this study was to determine whether increased exposure to antibiotics is associated with increased prevalence of invasive Candida infection .
-METHODS	Substudy using data from a randomized controlled trial , the Procalcitonin And Survival Study 2006-2010 .
-METHODS	Nine multidisciplinary ICUs across Denmark .
-METHODS	A total of 1,200 critically ill patients .
-METHODS	Patients were randomly allocated to either a `` high exposure '' antibiotic therapy ( intervention arm , n = 604 ) or a `` standard exposure '' guided by current guidelines ( n = 596 ) .
-RESULTS	Seventy-four patients met the endpoint , `` invasive Candida infection , '' 40 in the high exposure arm and 34 in standard exposure arm ( relative risk = 1.2 ; 95 % CI , 0.7-1 .8 ; p = 0.52 ) .
-RESULTS	Among medical patients in the high exposure arm , the use of ciprofloxacin and piperacillin/tazobactam was 51 % and 75 % higher than in the standard exposure arm ; no difference in antibiotic exposure was observed between the randomized arms in surgical patients .
-RESULTS	Among medical intensive care patients , invasive Candida infection was more frequent in the high exposure arm ( 6.2 % ; 27/437 ) than in standard exposure arm ( 3.3 % ; 14/424 ) ( hazard ratio = 1.9 ; 95 % CI , 1.0-3 .6 ; p = 0.05 ) .
-RESULTS	Ciprofloxacin used at study entry independently predicted invasive Candida infection ( adjusted hazard ratio = 2.1 [ 1.1-4 .1 ] ) ; the risk gradually increased with duration of ciprofloxacin therapy : six of 384 in patients not exposed ( 1.6 % ) , eight of 212 ( 3.8 % ) when used for 1-2 days ( hazard ratio = 2.5 ; 95 % CI , 0.9-7 .3 ) , and 31 of 493 ( 6.3 % ) when used for 3 days ( hazard ratio = 3.8 ; 95 % CI , 1.6-9 .3 ; p = 0.002 ) .
-RESULTS	Patients with any ciprofloxacin-containing antibiotic regimen the first 3 days in the trial had a higher risk of invasive Candida infection than did patients on any antibiotic regimen not containing ciprofloxacin ( unadjusted hazard ratio = 3.7 ; 95 % CI , 1.6-8 .7 ; p = 0.003 ; adjusted hazard ratio , 3.4 ; 95 % CI , 1.4-8 .0 ; p = 0.006 ) .
-CONCLUSIONS	High exposure to antibiotics is associated to increased risk of invasive Candida infection in medical intensive care patients .
-CONCLUSIONS	Patients with ciprofloxacin-containing regimens had higher risk of invasive Candida infection .
-CONCLUSIONS	Other antibiotics , such as meropenem , piperacillin/tazobactam , and cefuroxime , were not associated with such a risk .
-
-###24323030
-OBJECTIVE	A combination of aprepitant , a 5-HT3 receptor antagonist , and dexamethasone is recommended for the prophylaxis of acute or delayed emesis induced by chemotherapy containing anthracyclines plus cyclophosphamide in patients with breast cancer .
-OBJECTIVE	The aim of this study was to verify whether dexamethasone is superior to aprepitant in preventing delayed emesis in patients receiving the same prophylaxis for acute emesis .
-METHODS	A randomized double-blind study comparing aprepitant versus dexamethasone was completed in chemotherapy-naive patients with breast cancer treated with anthracyclines plus cyclophosphamide .
-METHODS	Before chemotherapy , all patients were treated with intravenous palonosetron 0.25 mg , dexamethasone 8 mg , and oral aprepitant 125 mg .
-METHODS	On days 2 and 3 , patients randomly received oral dexamethasone 4 mg twice per day or aprepitant 80 mg once per day .
-METHODS	Primary end point was rate of complete response ( ie , no vomiting or rescue treatment ) from days 2 to 5 after chemotherapy .
-RESULTS	Of 580 enrolled patients , 551 were evaluable : 273 received dexamethasone , and 278 received aprepitant .
-RESULTS	Day 1 complete response rates were similar : 87.6 % for dexamethasone and 84.9 % for aprepitant ( P < .39 ) .
-RESULTS	From days 2 to 5 , complete response rates were the same with both antiemetic prophylaxes ( 79.5 % ; P < 1.00 ) , as were results of secondary end points ( ie , complete protection , total control , no vomiting , no nausea , score of Functional Living Index-Emesis ; P < .24 ) .
-RESULTS	Incidences of insomnia ( 2.9 % v 0.4 % ; P < .02 ) and heartburn ( 8.1 % v 3.6 % ; P < .03 ) were significantly greater with dexamethasone on days 2 to 5 .
-CONCLUSIONS	In patients with breast cancer treated with anthracycline plus cyclophosphamide chemotherapy and receiving the same antiemetic prophylaxis for acute emesis , dexamethasone was not superior to aprepitant but instead had similar efficacy and toxicity in preventing delayed emesis .
-
-###25402495
-OBJECTIVE	Hyperkalemia is a common electrolyte abnormality that may be difficult to manage because of a lack of effective therapies .
-OBJECTIVE	Sodium zirconium cyclosilicate is a nonabsorbed cation exchanger that selectively binds potassium in the intestine .
-OBJECTIVE	To evaluate the efficacy and safety of zirconium cyclosilicate for 28 days in patients with hyperkalemia .
-METHODS	HARMONIZE was a phase 3 , multicenter , randomized , double-blind , placebo-controlled trial evaluating zirconium cyclosilicate in outpatients with hyperkalemia ( serum potassium 5.1 mEq/L ) recruited from 44 sites in the United States , Australia , and South Africa ( March-August 2014 ) .
-METHODS	Patients ( n = 258 ) received 10 g of zirconium cyclosilicate 3 times daily in the initial 48-hour open-label phase .
-METHODS	Patients ( n = 237 ) achieving normokalemia ( 3.5-5 .0 mEq/L ) were then randomized to receive zirconium cyclosilicate , 5 g ( n = 45 patients ) , 10 g ( n = 51 ) , or 15 g ( n = 56 ) , or placebo ( n = 85 ) daily for 28 days .
-METHODS	The primary end point was mean serum potassium level in each zirconium cyclosilicate group vs placebo during days 8-29 of the randomized phase .
-RESULTS	In the open-label phase , serum potassium levels declined from 5.6 mEq/L at baseline to 4.5 mEq/L at 48 hours .
-RESULTS	Median time to normalization was 2.2 hours , with 84 % of patients ( 95 % CI , 79 % -88 % ) achieving normokalemia by 24 hours and 98 % ( 95 % CI , 96 % -99 % ) by 48 hours .
-RESULTS	In the randomized phase , serum potassium was significantly lower during days 8-29 with all 3 zirconium cyclosilicate doses vs placebo ( 4.8 mEq/L [ 95 % CI , 4.6-4 .9 ] , 4.5 mEq/L [ 95 % CI , 4.4-4 .6 ] , and 4.4 mEq/L [ 95 % CI , 4.3-4 .5 ] for 5 g , 10 g , and 15 g ; 5.1 mEq/L [ 95 % CI , 5.0-5 .2 ] for placebo ; P < .001 for all comparisons ) .
-RESULTS	The proportion of patients with mean potassium < 5.1 mEq/L during days 8-29 was significantly higher in all zirconium cyclosilicate groups vs placebo ( 36/45 [ 80 % ] , 45/50 [ 90 % ] , and 51/54 [ 94 % ] for the 5-g , 10-g , and 15-g groups , vs 38/82 [ 46 % ] with placebo ; P < .001 for each dose vs placebo ) .
-RESULTS	Adverse events were comparable between zirconium cyclosilicate and placebo , although edema was more common in the 15-g group ( edema incidence : 2/85 [ 2 % ] , 1/45 [ 2 % ] , 3/51 [ 6 % ] , and 8/56 [ 14 % ] patients in the placebo , 5-g , 10-g , and 15-g groups ) .
-RESULTS	Hypokalemia developed in 5/51 ( 10 % ) and 6/56 patients ( 11 % ) in the 10-g and 15-g zirconium cyclosilicate groups , vs none in the 5-g or placebo groups .
-CONCLUSIONS	Among outpatients with hyperkalemia , open-label sodium zirconium cyclosilicate reduced serum potassium to normal levels within 48 hours ; compared with placebo , all 3 doses of zirconium cyclosilicate resulted in lower potassium levels and a higher proportion of patients with normal potassium levels for up to 28 days .
-CONCLUSIONS	Further studies are needed to evaluate the efficacy and safety of zirconium cyclosilicate beyond 4 weeks and to assess long-term clinical outcomes .
-BACKGROUND	clinicaltrials.gov Identifier : NCT02088073 .
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-###24515927
-BACKGROUND	Video games have become popular in stroke rehabilitation ; however , the nature of this intervention is not fully understood .
-OBJECTIVE	To compare the number of ( a ) purposeful and nonpurposeful repetitions of the weaker upper extremity ( UE ) and ( b ) movement accelerations as assessed by accelerometer activity counts of the weaker and stronger UEs of individuals with chronic stroke while playing video games or participating in traditional therapy .
-METHODS	Twenty-nine individuals ( mean age 59 years , 1-7 years poststroke ) took part in a group intervention of video - games ( n = 15 ) or traditional therapy ( n = 14 ) as part of a randomized controlled trial .
-METHODS	During 1-2 sessions , participants were video-taped while wearing wrist accelerometers .
-METHODS	Assessors counted the number of repetitions and classified movements as purposeful or nonpurposeful using videotapes .
-METHODS	The weaker UE motor impairments were correlated to movement accelerations , to determine if participants were using their potential during the sessions .
-RESULTS	Participants in the video game group performed a median of 271 purposeful movements and 37 970 activity counts compared to 48 purposeful movements and 14,872 activity counts in the traditional group ( z = -3.0 , P = .001 and z = -1.9 , P = .05 , respectively ) .
-RESULTS	Participants in the traditional group performed a median of 26 nonpurposeful ( exercises ) compared with 0 in the video game group ( z = -4.2 , P = .000 ) .
-RESULTS	Strong significant correlations were found between the motor ability of the weak UE to repetitions of participants in both groups ( r = .86 , P < .01 ) .
-RESULTS	Participants with higher motor ability performed more repetitions .
-CONCLUSIONS	Video games elicited more UE purposeful repetitions and higher acceleration of movement compared with traditional therapy in individuals with chronic stroke .
-
-###25972260
-OBJECTIVE	To determine whether scatter and grid laser photocoagulation ( laser ) adds benefit to ranibizumab injections in patients with macular edema from retinal vein occlusion ( RVO ) and to compare 0.5-mg with 2.0-mg ranibizumab .
-METHODS	Randomized , double-masked , controlled clinical trial .
-METHODS	Thirty-nine patients with central RVO ( CRVO ) and 42 with branch RVO ( BRVO ) .
-METHODS	Subjects were randomized to 0.5 mg or 2.0 mg ranibizumab every 4 weeks for 24 weeks and re-randomized to pro re nata ranibizumab plus laser or ranibizumab alone .
-METHODS	Mean change from baseline best-corrected visual acuity ( BCVA ) at week 24 for BCVA at weeks 48 , 96 , and 144 for second randomization .
-RESULTS	Mean improvement from baseline BCVA at week 24 was 15.5 and 15.8 letters in the 0.5-mg and 2.0-mg CRVO groups , and 12.1 and 14.6 letters in the 0.5-mg and 2.0-mg BRVO groups .
-RESULTS	For CRVO , but not BRVO , there was significantly greater reduction from baseline mean central subfield thickness ( CST ) in the 2.0-mg versus 0.5-mg group ( 396.1 vs. 253.5 m ; P = 0.03 ) .
-RESULTS	For the second randomization in CRVO patients , there was no significant difference from week 24 BCVA in the ranibizumab plus laser versus the ranibizumab only groups at week 48 ( -3.3 vs. 0.0 letters ) , week 96 ( +0.69 vs. -1.6 letters ) , or week 144 ( +0.4 vs. -6.7 letters ) , and a significant increase from week 24 mean CST at week 48 ( +94.7 vs. +15.2 m ; P = 0.05 ) but not weeks 96 or 144 .
-RESULTS	For BRVO , there was a significant reduction from week 24 mean BCVA in ranibizumab plus laser versus ranibizumab at week 48 ( -7.5 vs. +2.8 ; P < 0.01 ) and week 96 ( -2.0 vs. +4.8 ; P < 0.03 ) , but not week 144 , and there were no differences in mean CST change from week 24 at weeks 48 , 96 , or 144 .
-RESULTS	Laser failed to increase edema resolution or to reduce the ranibizumab injections between weeks 24 and 144 .
-CONCLUSIONS	In patients with macular edema resulting from RVO , there was no short-term clinically significant benefit from monthly injections of 2.0-mg versus 0.5-mg ranibizumab injections and no long-term benefit in BCVA , resolution of edema , or number of ranibizumab injections obtained by addition of laser treatment to ranibizumab .
-
-###24751470
-BACKGROUND	A UK study showed final height in Turner syndrome ( TS ) girls receiving growth hormone is affected by age at pubertal induction and oxandrolone ( Ox ) .
-BACKGROUND	Using data from that study , we analysed the effect of timing of oral ethinylestradiol ( EE2 ) and Ox on height velocity ( HV ) , bone maturation and pubertal progression , and compared growth response in EE2-treated versus spontaneous puberty .
-METHODS	Analysis of HV , bone age and pubertal stage in 92 TS girls ( 7-13 years ) randomised to Ox ( 0.05 mg/kg/day ; max : 2.5 mg/day ) or placebo from 9 years , and EE2 ( year 1 : 2 g/day ; year 2 : 4 g/day ; year 3 : 6/8/10 g/day4 months ) or placebo at 12 years with EE2 at 14 years .
-METHODS	Girls enrolled at > 12.25 years received EE2 at 14 years ( ` late group ' ) .
-RESULTS	Fifty-six girls were randomised to EE2 at 12 years ( n = 28 , 11 Ox ) or 14 years ( n = 28 , 13 Ox ) ; there were 19 girls in the late group ( 9 Ox ) and 17 girls with spontaneous puberty ( 10 Ox ) .
-RESULTS	Girls receiving EE2 at 12 versus 14 years had faster bone maturation , but neither group showed acceleration .
-RESULTS	Ox increased HV without altering bone maturation or pubertal progression .
-RESULTS	Girls with spontaneous puberty had greater pubertal growth ( mean PHV 8.5 cm/year ; p < 0.001 ) and height gain ( p < 0.001 ) than EE2-treated girls despite similar mean enrolment height SD and dysmorphology scores .
-CONCLUSIONS	Pubertal induction with EE2 does not replicate the acceleration observed in unaffected girls or TS girls with spontaneous puberty .
-
-###24456145
-OBJECTIVE	The purpose of this study was to investigate the long-term clinical course of normotensive preperimetric glaucoma ( PPG ) .
-METHODS	The medical records of 71 eyes of 71 patients with normotensive PPG who underwent intraocular pressure ( IOP ) - lowering therapy were reviewed retrospectively .
-METHODS	The patients had been regularly followed up at 3 - to 6-month intervals between 1996 and 2011 .
-METHODS	Progression was evaluated by comparing the structural changes of serial stereoscopic colour disc and red-free retinal nerve fibre layer ( RNFL ) photographs and by comparing serial visual field ( VF ) test results for functional changes .
-RESULTS	Over an average follow-up period of 6.8 years , 41 eyes ( 57.7 % ) showed progression in either structural or functional evaluation .
-RESULTS	Disc haemorrhage ( DH ) was observed significantly more frequently in the progressing group ( p < 0.005 ) ; however , there were no differences in mean age , gender ratio , follow-up period and ocular characteristics at baseline such as IOP , RNFL defects and global indices of VF between the non-progressing and progressing groups .
-RESULTS	Thirty eyes ( 42.3 % ) showed significant angular widening of the localized RNFL defect towards the macula at a mean rate of approximately 1/year .
-RESULTS	Perimetric glaucoma developed in 19 eyes ( 26.8 % ) , and the rate of change in the mean deviation was -0.23 dB/year .
-RESULTS	Preperimetric glaucoma patients with DH or IOP reductions of < 20 % from the baseline had a higher probability of RNFL deterioration than patients without DH or IOP reductions of 20 % from the baseline by multivariate analysis .
-CONCLUSIONS	Although the rates of change were typically slow , more than half of normotensive patients with PPG showed statistically significant progressive structural or functional changes in medically treated cases .
-CONCLUSIONS	DH or IOP reductions of < 20 % from the baseline were shown as a significant risk factor for the progression of PPG .
-
-###24815499
-BACKGROUND	Patients with heart failure ( HF ) who live in rural areas have less access to cardiac services than patients in urban areas .
-BACKGROUND	We conducted a randomized , clinical trial to determine the impact of an educational intervention on the composite end point of HF rehospitalization and cardiac death in this population .
-RESULTS	Patients ( n = 602 ; age , 6613 years ; 41 % female ; 51 % with systolic HF ) were randomized to 1 of 3 groups : control ( usual care ) , Fluid Watchers LITE , or Fluid Watchers PLUS .
-RESULTS	Both intervention groups included a face-to-face education session delivered by a nurse focusing on self-care .
-RESULTS	The LITE group received 2 follow-up phone calls , whereas the PLUS group received biweekly calls ( mean , 5.33.6 ; range , 1-19 ) until the nurse judged the patient to be adequately trained .
-RESULTS	Over 2 years of follow-up , 35 % of patients ( n = 211 ) experienced cardiac death or hospitalization for HF , with no difference among the 3 groups in the proportion who experienced the combined clinical outcome ( P = 0.06 ) .
-RESULTS	Although patients in the LITE group had reduced cardiac mortality compared with patients in the control group over the 2 years of follow-up ( 7.5 % and 17.7 % , respectively ; P = 0.003 ) , there was no significant difference in cardiac mortality between patients in the PLUS group and the control group .
-CONCLUSIONS	A face-to-face education intervention did not significantly decrease the combined end point of cardiac death or hospitalization for HF .
-CONCLUSIONS	Increasing the number of contacts between the patient and nurse did not significantly improve outcome .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00415545 .
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-###24599772
-BACKGROUND	Physical exercise could improve functional limitations , muscle mass , and health-related quality of life ( HRQoL ) in patients with cirrhosis .
-OBJECTIVE	The purpose of this study was to evaluate the efficacy and safety of an exercise programme and leucine supplementation to increase exercise capacity , muscle mass , and HRQoL in patients with cirrhosis .
-METHODS	Seventeen outpatients with cirrhosis were randomized to an exercise group ( n = 8 ) or a control group ( n = 9 ) in a pilot study .
-METHODS	The programme of moderate exercise was performed for 12 weeks under supervision of a physiotherapist .
-METHODS	All patients received oral leucine ( 10 g/day ) during the study .
-METHODS	At baseline and at the end of the study , we determined exercise capacity ( 6-min walk and 2-min step tests ) , anthropometric measurements , and HRQoL by Short Form-36 ( SF-36 ) questionnaire .
-METHODS	We also analyzed safety regarding complications of cirrhosis , liver and renal function , inflammatory response and oxidative stress .
-RESULTS	In the exercise group , exercise capacity improved , as shown by the increase in the 6-min walk test from 365 ( 160-420 ) to 445 m ( 250-500 ) ( p = 0.01 ) , and in the 2-min step test ( p = 0.02 ) .
-RESULTS	Lower thigh circumference also increased , from 41 ( 34-53 ) to 46 cm ( 36-56 ) ( p = 0.02 ) , and the domains of SF-36 general health ( p = 0.03 ) , vitality ( p = 0.01 ) and social function ( p = 0.04 ) improved significantly .
-RESULTS	In the control group , no statistically significant changes were observed in any of the parameters .
-RESULTS	We did not observe complications of cirrhosis in either group during the study .
-CONCLUSIONS	A programme of moderate physical exercise together with leucine supplements in patients with cirrhosis is safe and improves exercise capacity , leg muscle mass and HRQoL .
-
-###24505216
-BACKGROUND	Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement .
-BACKGROUND	The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes .
-RESULTS	All 933,789 people aged 40 years with diagnosed diabetes in Ontario , Canada were studied using population-level administrative databases , with additional clinical outcome data collected from a random sample of 1,592 high risk patients .
-RESULTS	Family practices were randomly assigned to receive the educational toolkit in June 2009 ( intervention group ) or May 2010 ( control group ) .
-RESULTS	The primary outcome in the administrative data study , death or non-fatal myocardial infarction , occurred in 11,736 ( 2.5 % ) patients in the intervention group and 11,536 ( 2.5 % ) in the control group ( p = 0.77 ) .
-RESULTS	The primary outcome in the clinical data study , use of a statin , occurred in 700 ( 88.1 % ) patients in the intervention group and 725 ( 90.1 % ) in the control group ( p = 0.26 ) .
-RESULTS	Pre-specified secondary outcomes , including other clinical events , processes of care , and measures of risk factor control , were also not improved by the intervention .
-RESULTS	A limitation is the high baseline rate of statin prescribing in this population .
-CONCLUSIONS	The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes .
-CONCLUSIONS	Despite being relatively easy and inexpensive to implement , printed educational materials were not effective .
-CONCLUSIONS	The study highlights the need for a rigorous and scientifically based approach to the development , dissemination , and evaluation of quality improvement interventions .
-BACKGROUND	http://www.ClinicalTrials.gov NCT01411865 and NCT01026688 .
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-###24555913
-OBJECTIVE	Increased consumption of omega-3 polyunsaturated fatty acids ( PUFA ) together with lifestyle measures and medications is recommended for the prevention of cardiovascular diseases .
-OBJECTIVE	However , the exact mechanisms underlying observed benefits are not well defined .
-OBJECTIVE	To this aim , we evaluated the effects of omega-3 PUFA in stable coronary artery disease ( CAD ) patients undergoing percutaneous coronary intervention ( PCI ) on lipoprotein associated phospholipase A2 ( Lp-PLA2 ) mass and activity and their relation to oxidized low-density lipoproteins ( oxy-LDL ) .
-RESULTS	In a prospective , double-blind , placebo-controlled , randomized study Lp-PLA2 , oxy-LDL , myeloperoxidase and interleukin-6 were determined at baseline , 3-5 days and 30 days during administration of omega-3 PUFA 1g/day ( n = 30 ) or placebo ( n = 24 ) .
-RESULTS	Treatment with omega-3 PUFA resulted in reduction of Lp-PLA2 mass by 10.7 % , activity by 9.3 ( p = 0.026 for both ) and oxy-LDL by 10.9 % ( p = 0.014 ) at 30 days , with no change in myeloperoxidase and interleukin-6 .
-RESULTS	Compared with placebo , patients receiving omega-3 PUFA had lower Lp-PLA2 mass by 9.42 % , activity by 9.2 ( p = 0.041 for both ) and oxy-LDL by 12.3 % ( p = 0.10 ) after one month , but not at 3-5 days .
-RESULTS	There were no correlations between Lp-PLA2 and both myeloperoxidase and oxy-LDL throughout the study .
-RESULTS	The multivariate model showed that only treatment with omega-3 PUFA and baseline myeloperoxidase levels were independent predictors of Lp-PLA2 mass changes at one month ( R ( 2 ) = 0.37 , P = 0.005 ) .
-CONCLUSIONS	Administration of omega-3 PUFA can decrease Lp-PLA2 in patients with stable angina undergoing PCI .
-CONCLUSIONS	This novel effect may contribute to the benefits derived from omega-3 PUF .
-
-###24525155
-BACKGROUND	It is necessary to develop a new thrombolytic agent which can be used by a single bolus at first aid sites to decrease the time to reperfusion in clinical practice .
-BACKGROUND	HTUPA , a genetically engineered new thrombolytic with a longer half-life , is well qualified .
-BACKGROUND	We aim to compare the thrombolytic efficacy and safety of human tissue urokinase type plasminogen activator ( HTUPA ) to recombinant tissue plasminogen activator ( rt-PA ) in Chinese patients with acute myocardial infarction ( AMI ) .
-METHODS	AMI patients ( n = 221 ) were randomized to rt-PA ( a standard protocol ) or HTUPA ( 25 mg bolus ) treatment groups .
-METHODS	All patients also received oral aspirin and intravenous heparin .
-METHODS	Coronary angiography was performed 90 min after therapy initiation to determine infarct-related coronary artery ( IRA ) patency .
-METHODS	Clinical outcomes and changes of clotting variables , heart rate , blood pressure , left ventricular ejection fraction ( LVEF ) , and electrocardiogram were evaluated .
-RESULTS	Patent IRA [ thrombolysis in myocardial infarction ( TIMI ) grade 2 or 3 ] was observed in 77 % of HTUPA-treated patients , compared to 76 % of rt-PA-treated patients ( P = 0.76 ) .
-RESULTS	TIMI grade 3 patency rates were 52 % and 44 % in the HTUPA and rt-PA groups , respectively ( P = 0.37 ) .
-RESULTS	The total patency rate was 77 % ( 86/111 patients ) in the HTUPA group and 73 % ( 80/110 patients ) in the rt-PA group ( P = 0.41 ) .
-RESULTS	Adverse events were infrequent in both groups , and no significant differences were detected in mortality , re-occlusion rate , revascularization rate , adverse effects , clotting index , LVEF , or electrocardiogram between the two groups .
-CONCLUSIONS	Intravenous HTUPA had a safe and efficacious profile as good as rt-PA in patients with AMI .
-
-###25432688
-BACKGROUND	Uterine fibroids are the most common tumour in women of reproductive age .
-BACKGROUND	By the time they are 50-years-old around 80 % of women will have developed one .
-BACKGROUND	Of these , around half will experience symptoms which will impact negatively on their quality of life .
-BACKGROUND	Hysterectomy is the traditional treatment for women with symptomatic fibroids .
-BACKGROUND	For women who do not wish to undergo a hysterectomy , two invasive treatments are commonly available : myomectomy or uterine artery embolization ( UAE ) .
-METHODS	FEMME is a pragmatic , randomised , open , multi-centre trial examining the quality of life menstruating women with symptomatic fibroids experience after treatment with UAE or myomectomy .
-METHODS	After providing informed consent , 216 women with symptomatic fibroids from 43 NHS Hospital Trusts and Health Boards across the United Kingdom will undergo randomisation by a centralised computer system to treatment by either UAE or myomectomy .
-METHODS	A minimisation algorithm will be used in order to balance the groups with respect to the following three parameters : the longest dimension of the largest fibroid , the number of fibroids present , and whether the woman currently desires pregnancy.Using validated questionnaires the women 's quality of life will be compared between groups at six months , one year , two years and four years post-procedure , taking into account pre-procedure scores .
-METHODS	An economic evaluation will be conducted alongside the trial to determine the cost-effectiveness of UAE compared with myomectomy.Validated diaries will also be used to compare menstrual blood loss at the same time-points .
-METHODS	The plasma concentration of Anti-Mllerian hormone ( AMH ) , which will act as a proxy measurement of ovarian reserve , will be recorded before the woman has her procedure and then again at six weeks , six months , and twelve months afterwards .
-METHODS	Re-intervention rates will be recorded .
-CONCLUSIONS	The FEMME trial 's primary outcome is the quality of life women with symptomatic uterine fibroids experience two years after they have been treated with either UAE or myomectomy , as measured by the disease-specific Uterine Fibroid Symptom Quality-of-Life ( UFS-QoL ) questionnaire .
-BACKGROUND	Current Controlled Trials registration number : ISRCTN70772394 , registered on 2 March 2013 .
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-###26132682
-OBJECTIVE	To evaluate the efficacy and safety of acupuncture for residual insomnia and other residual symptoms associated with major depressive disorder ( MDD ) .
-METHODS	150 participants having significant insomnia for more than 3 months and a history of MDD ( both based on DSM-IV-TR criteria ) were recruited from 4 psychiatric outpatient clinics in Hong Kong from May 2011 to August 2013 to receive 9 sessions of treatment over 3 weeks .
-METHODS	They were randomized to receive acupuncture , minimal acupuncture , or placebo acupuncture .
-METHODS	Primary outcome was sleep diary-derived sleep efficiency .
-METHODS	Secondary outcomes included other sleep diary parameters , actigraphy , anxiety and depressive symptoms , daytime functioning , and adverse events .
-RESULTS	The mean difference in sleep diary-derived sleep efficiency at 1-week posttreatment was -1.40 ( 95 % CI , -7.08 to 4.28 ) between the acupuncture and minimal acupuncture groups and was 3.10 ( 95 % CI , -3.64 to 9.84 ) between the acupuncture and placebo acupuncture groups .
-RESULTS	A ( 2 ) test showed that acupuncture produced a significantly higher proportion of participants achieving sleep-onset latency 30 minutes than did minimal acupuncture at 1-week posttreatment ( P = .04 ) .
-RESULTS	However , there was no significant between-group difference in most of the other outcomes .
-RESULTS	Treatment blinding was successful , as a majority of participants did not know which treatment they had received .
-CONCLUSIONS	Acupuncture was well tolerated , but the efficacy was only mild and similar to that of minimal acupuncture and placebo acupuncture .
-CONCLUSIONS	A high proportion of patients remained clinically significantly affected by insomnia after treatment .
-CONCLUSIONS	The finding raises certain doubts about the value of acupuncture and underscores the difficulties in the treatment of residual insomnia in MDD .
-BACKGROUND	ClinicalTrials.gov identifier : NCT01707706 .
-
-###24911580
-OBJECTIVE	The neuropeptide oxytocin is implicated in social processing , and recent research has begun to explore how gender relates to the reported effects .
-OBJECTIVE	This study examined the effects of oxytocin on social affective perception and learning .
-METHODS	Forty-seven male and female participants made judgments of faces during two different tasks , after being randomized to either double-blinded intranasal oxytocin or placebo .
-METHODS	In the first task , `` unseen '' affective stimuli were presented in a continuous flash suppression paradigm , and participants evaluated faces paired with these stimuli on dimensions of competence , trustworthiness , and warmth .
-METHODS	In the second task , participants learned affective associations between neutral faces and affective acts through a gossip learning procedure and later made affective ratings of the faces .
-RESULTS	In both tasks , we found that gender moderated the effect of oxytocin , such that male participants in the oxytocin condition rated faces more negatively , compared with placebo .
-RESULTS	The opposite pattern of findings emerged for female participants : they rated faces more positively in the oxytocin condition , compared with placebo .
-CONCLUSIONS	These findings contribute to a small but growing body of research demonstrating differential effects of oxytocin in men and women .
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-###24750568
-BACKGROUND	A non-steroidal , anti-inflammatory moisturizing cream containing rhamnosoft , ceramides , and L-isoleucine ( ILE ) ( pro-AMP cream ) has been recently developed for the specific treatment of atopic eczema ( AE ) of the face .
-BACKGROUND	In this trial , we evaluated the clinical efficacy and tolerability of pro-AMP cream in the treatment of facial AE in children in comparison with an emollient cream .
-METHODS	In a randomized , prospective , assessor-blinded , parallel groups ( 2:1 ) controlled trial , 107 children ( 72 allocated to pro-AMP cream and 35 allocated to control group ) with mild-to-moderate chronic AE of the face were enrolled .
-METHODS	Treatments were applied twice daily for a 6-week period .
-METHODS	Facial Eczema Severity Score ( ESS ) was evaluated at baseline , week 3 , and week 6 , by an assessor unaware of treatment allocation .
-METHODS	Investigators Global Assessment ( IGA ) score was assessed at week 3 and at week 6 .
-METHODS	Tolerability was evaluated at week 3 and at week 6 using a4-point score ( from 0 : low tolerability to 3 : very good tolerability ) .
-RESULTS	At baseline ESS , mean ( SD ) was 6.1 ( 2.4 ) in the pro-AMP cream group and 5.3 ( 3 ) in the control group .
-RESULTS	In the pro-AMP group , in comparison with baseline , ESS was significantly reduced to 2.5 ( -59 % ) after 3 wks and to 1.0 ( -84 % ) at week 6 ( p = 0.0001 ) .
-RESULTS	In the control group , ESS was reduced to 3 ( -42 % ) at week 2 and to 2.6 ( -50 % ) at week 6 .
-RESULTS	At week 6 , ESS in pro-AMP cream was significantly lower than the control group ( 1.0 vs. 2.6 ; p = 0.001 ) .
-RESULTS	Both products were well tolerated .
-CONCLUSIONS	Pro-AMP cream has shown to be effective in the treatment of mild-to moderate chronic lesion of AE of the face .
-CONCLUSIONS	Clinical efficacy was greater in comparison with an emollient cream .
-BACKGROUND	NTR4084 ) .
-
-###25374187
-BACKGROUND	Survival rates after resection of advanced gastric cancer are extremely poor .
-BACKGROUND	An increasing number of patients with gastric carcinomas ( GC ) are therefore being treated with preoperative chemotherapy .
-BACKGROUND	We evaluated 36 month survival rate of GC patients that were treated by adding a neoadjuvant chemoradiotherapy before gastrostomy .
-METHODS	Patients with stage II or III gastric adenocarcinomas were enrolled .
-METHODS	The patients divided into two groups : ( A ) Neoadjuvant group that received concurrent chemoradiation before surgery ( 4,500 cGy of radiation at 180 cGy per day plus chemotherapy with cisplatin and 5-fluorouracil , in the first and the end four days of radiotherapy ) .
-METHODS	Resection was attempted 5 to 6 weeks after end of chemoradiotherapy .
-METHODS	( B ) Adjuvant group that received concurrent chemo-radiation after surgical resection .
-RESULTS	Two ( 16.7 % ) patients out of 12 patients treated with neoadjuvant chemo-radiotherapy and 5 ( 38.5 % ) out of 13 in the surgery group survived after 36 months .
-RESULTS	These rates were not significantly different with per protocol and intention-to-treat analysis .
-RESULTS	The median survival time of patients in group A and B were 13.4 and 21.6 months , respectively , again not significantly different .
-RESULTS	Survival was significantly greater in patients with well differentiated adenocarcinoma in group B than in group A ( p < 0.004 ) .
-CONCLUSIONS	According to this study we suggest surgery then chemoradiotherapy for patients with well differentiated gastric adenocarcinoma rather than other approaches .
-CONCLUSIONS	Additional studies with greater sample size and accurate matching relying on cancer molecular behavior are recommended .
-
-###25600977
-OBJECTIVE	This study assessed the impact of varying lenvatinib crystalline forms in 10-mg lenvatinib capsules on drug bioavailability in healthy volunteers .
-METHODS	Lenvatinib 10-mg capsules ( low C and high C forms ) .
-METHODS	This randomized , three-period - crossover study compared the pharmacokinetics and safety of two crystalline forms of capsules ( low C-form , < 4 % crystalline ; high C-form , 38 % crystalline ) to a standard ( ref Cform , 15 % crystalline ) .
-RESULTS	59 subjects were evaluable for pharmacokinetics .
-RESULTS	Test/reference ratios of the geometric least squares means ( LSM ) and 90 % confidence intervals ( CI ) for AUC0-t ( t up to 120 hours ) , AUC0 - , and Cmax for low C-form vs. ref C-form were 101 ( 94.8 , 107 ) , 101 ( 95.3 , 107 ) , and 98.7 ( 88.6 , 110 ) , respectively ; and for high C-form vs. ref C-form were 96.0 ( 92.1 , 100 ) , 96.5 ( 92.5 , 101 ) , and 90.6 ( 83.5 , 98.4 ) , respectively .
-RESULTS	The incidence of treatment-emergent adverse events ( TEAE ) and treatment-related adverse events ( TRAE ) were comparable between all formulations ( TEAE range 20-24 % ; TRAE range 15-19 % ) .
-RESULTS	One serious TRAE ( spontaneous abortion ) occurred in the low C-form group .
-CONCLUSIONS	For both comparisons , the 90 % CIs of the test/reference ratios were within the regulatory acceptance range ( 80-125 % ) , suggesting that both test formulations ( low Cform and high C-form ) were bioequivalent to the reference formulation for Cmax , AUC0-t , and AUC0 - .
-
-###26200978
-BACKGROUND	The effect of internal mammary and medial supraclavicular lymph-node irradiation ( regional nodal irradiation ) added to whole-breast or thoracic-wall irradiation after surgery on survival among women with early-stage breast cancer is unknown .
-METHODS	We randomly assigned women who had a centrally or medially located primary tumor , irrespective of axillary involvement , or an externally located tumor with axillary involvement to undergo either whole-breast or thoracic-wall irradiation in addition to regional nodal irradiation ( nodal-irradiation group ) or whole-breast or thoracic-wall irradiation alone ( control group ) .
-METHODS	The primary end point was overall survival .
-METHODS	Secondary end points were the rates of disease-free survival , survival free from distant disease , and death from breast cancer .
-RESULTS	Between 1996 and 2004 , a total of 4004 patients underwent randomization .
-RESULTS	The majority of patients ( 76.1 % ) underwent breast-conserving surgery .
-RESULTS	After mastectomy , 73.4 % of the patients in both groups underwent chest-wall irradiation .
-RESULTS	Nearly all patients with node-positive disease ( 99.0 % ) and 66.3 % of patients with node-negative disease received adjuvant systemic treatment .
-RESULTS	At a median follow-up of 10.9 years , 811 patients had died .
-RESULTS	At 10 years , overall survival was 82.3 % in the nodal-irradiation group and 80.7 % in the control group ( hazard ratio for death with nodal irradiation , 0.87 ; 95 % confidence interval [ CI ] , 0.76 to 1.00 ; P = 0.06 ) .
-RESULTS	The rate of disease-free survival was 72.1 % in the nodal-irradiation group and 69.1 % in the control group ( hazard ratio for disease progression or death , 0.89 ; 95 % CI , 0.80 to 1.00 ; P = 0.04 ) , the rate of distant disease-free survival was 78.0 % versus 75.0 % ( hazard ratio , 0.86 ; 95 % CI , 0.76 to 0.98 ; P = 0.02 ) , and breast-cancer mortality was 12.5 % versus 14.4 % ( hazard ratio , 0.82 ; 95 % CI , 0.70 to 0.97 ; P = 0.02 ) .
-RESULTS	Acute side effects of regional nodal irradiation were modest .
-CONCLUSIONS	In patients with early-stage breast cancer , irradiation of the regional nodes had a marginal effect on overall survival .
-CONCLUSIONS	Disease-free survival and distant disease-free survival were improved , and breast-cancer mortality was reduced .
-CONCLUSIONS	( Funded by Fonds Cancer ; ClinicalTrials.gov number , NCT00002851 . )
-
-###25435541
-BACKGROUND	Technological advances raise the possibility of systematic population-based genetic testing for cancer-predisposing mutations , but it is uncertain whether benefits outweigh disadvantages .
-BACKGROUND	We directly compared the psychological/quality-of-life consequences of such an approach to family history ( FH ) - based testing .
-METHODS	In a randomized controlled trial of BRCA1/2 gene-mutation testing in the Ashkenazi Jewish ( AJ ) population , we compared testing all participants in the population screening ( PS ) arm with testing those fulfilling standard FH-based clinical criteria ( FH arm ) .
-METHODS	Following a targeted community campaign , AJ participants older than 18 years were recruited by self-referral after pretest genetic counseling .
-METHODS	The effects of BRCA1/2 genetic testing on acceptability , psychological impact , and quality-of-life measures were assessed by random effects regression analysis .
-METHODS	All statistical tests were two-sided .
-RESULTS	One thousand , one hundred sixty-eight AJ individuals were counseled , 1042 consented , 1034 were randomly assigned ( 691 women , 343 men ) , and 1017 were eligible for analysis .
-RESULTS	Mean age was 54.3 ( SD = 14.66 ) years .
-RESULTS	Thirteen BRCA1/2 carriers were identified in the PS arm , nine in the FH arm .
-RESULTS	Five more carriers were detected among FH-negative FH-arm participants following study completion .
-RESULTS	There were no statistically significant differences between the FH and PS arms at seven days or three months on measures of anxiety , depression , health anxiety , distress , uncertainty , and quality-of-life .
-RESULTS	Contrast tests indicated that overall anxiety ( P = .0001 ) and uncertainty ( P = .005 ) associated with genetic testing decreased ; positive experience scores increased ( P = .0001 ) ; quality-of-life and health anxiety did not change with time .
-RESULTS	Overall , 56 % of carriers did not fulfill clinical criteria for genetic testing , and the BRCA1/2 prevalence was 2.45 % .
-CONCLUSIONS	Compared with FH-based testing , population-based genetic testing in Ashkenazi Jews does n't adversely affect short-term psychological/quality-of-life outcomes and may detect 56 % additional BRCA carriers .
-
-###25052334
-BACKGROUND	The use of nicotine replacement therapy before quitting smoking is called nicotine preloading .
-BACKGROUND	Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking ( quit day ) aiming to reduce withdrawal symptoms and craving .
-BACKGROUND	However , other , more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after .
-BACKGROUND	Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward .
-BACKGROUND	A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed .
-METHODS	This is a study protocol for a multicenter , non-blinded , randomized controlled trial based in the United Kingdom , enrolling 1786 smokers who want to quit , funded by the National Institute for Health Research , Health Technology Assessment program , and sponsored by the University of Oxford .
-METHODS	Participants will primarily be recruited through general practices and smoking cessation clinics , and randomized ( 1:1 ) either to use 21 mg nicotine patches , or not , for four weeks before quitting , whilst smoking as normal .
-METHODS	All participants will be referred to receive standard smoking cessation service support .
-METHODS	Follow-ups will take place at one week , four weeks , six months and 12 months after quit day .
-METHODS	The primary outcome will be prolonged , biochemically verified six-month abstinence .
-METHODS	Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration , side effects , costs of treatment , and markers of potential mediators and moderators of the preloading effect .
-CONCLUSIONS	This large trial will add substantially to evidence on the effectiveness of nicotine preloading , but also on its cost effectiveness and potential mediators , which have not been investigated in detail previously .
-CONCLUSIONS	A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample , and the multicentre design means that knowledge can be shared between recruitment teams .
-CONCLUSIONS	The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice .
-BACKGROUND	Current Controlled Trials ISRCTN33031001 .
-BACKGROUND	Registered 27 April 2012 .
-
-###24697948
-BACKGROUND	Sirolimus-eluting stents ( SES ) with a biodegradable polymer coating have demonstrated promising results but have not been compared to SES with a durable polymer in high-risk patients .
-BACKGROUND	We compared the efficacy of these 2 stent types in patients with acute myocardial infarction ( STEMI ) .
-METHODS	One thousand one hundred ninety-two STEMI patients were randomized to receive SES coated with biodegradable ( n = 596 ) or durable polymer ( n = 596 ) .
-METHODS	The study end-point was the composite of major adverse cardiac events ( MACE ) including all-cause death , recurrent myocardial infarction ( MI ) , or target lesion revascularization ( TLR ) at 1-year follow-up .
-METHODS	Secondary end-points included individual components of primary end-point and stent thrombosis .
-RESULTS	Compared with durable polymer SES , the noninferiority of SES with biodegradable polymer coating was established by an absolute risk difference of 0.9 % in the primary end-point ( 12.4 % vs. 13.3 % , P = 0.67 ) and an upper limit of one-sided 95 % confidence interval ( CI ) of 2.96 % ( P for noninferiority = 0.001 ) .
-RESULTS	Rate of death , recurrent MI , and TLR were 7.9 % and 8.6 % ( HR : 0.92 ; 95 % CI : 0.61-1 .38 , P = 0.67 ) , 2.9 % and 3.5 % ( HR : 0.80 ; 95 % CI : 0.42-1 .54 , P = 0.51 ) , and 2.0 % and 3.2 % ( HR : 0.62 ; 95 % CI : 0.30-1 .30 , P = 0.20 ) in the biodegradable polymer SES and durable polymer SES group at 1-year clinical follow-up , respectively .
-RESULTS	Despite similar rates of 30-day ARC definite/probable stent thrombosis , late stent thrombosis ( stent thrombosis occurring beyond 30 days ) was lower with biodegradable polymer SES ( 0.7 % vs. 2.2 % , P = 0.028 ) .
-CONCLUSIONS	In patients undergoing primary PCI for STEMI , the use of biodegradable polymer SES was associated with noninferior 1-year rates of MACE compared with durable polymer SES .
-
-###24261303
-OBJECTIVE	To compare the efficacy differences between acupuncture-moxibustion and physiotherapy interventions in improving proprioception of athletes with lateral collateral ligament injury of the ankle joint .
-METHODS	Thirty patients with injured lateral collateral ligament of ankle joint were randomly divided into acupuncture group ( n = 15 ) and physiotherapy group ( n = 15 ) .
-METHODS	Patients of the acupuncture group were treated by acupuncture and moxibustion stimulation of Qiuxu ( GB40 ) , Kunlun ( BL 60 ) , Shenmai ( BL 62 ) , Jiexi ( ST 41 ) , and Ashi-points , etc. , and those of the physiotherapy group treated with TDP irradiation of the regional lateral malleolus .
-METHODS	The treatment of the two groups was conducted once the other day , 3 times each week , continuously for 8 weeks .
-METHODS	Before and after the treatment , the ankle-joint 's active and passive repositioning error angles were measured by using a joint angle ruler .
-RESULTS	The average error angle values of active and passive reposition tests of the injured ankle-joint were 4.98 + / - 1.11 and 4.78 + / - 1.3 before the treatment , and 3.67 + / - 0.58 and 3.51 + / - 0.64 after the treatment , respectively in the acupuncture group , being reduced significantly after the treatment ( both P < 0.01 ) .
-RESULTS	No significant changes of the average error angle values of both active and passive reposition tests of the ankle-joint were found after the treatment in the physiotherapy group ( P > 0.05 ) .
-RESULTS	Comparison between two groups showed that the average error angle , average active and passive reposition angles of the injured ankle in the acupuncture group were evidently lower than those in the physiotherapy group ( P < 0.01 ) .
-CONCLUSIONS	Acupuncture and moxibustion can effectively improve the proprioception of the injured lateral collateral ligament of the ankle joint in athletes , which is superior to conventional physiotherapy in the therapeutic effect .
-
-###24245807
-BACKGROUND	Several studies show that psychological treatments relieve symptoms for patients suffering from irritable bowel syndrome ( IBS ) .
-BACKGROUND	However , there are no consistent findings that show what patient characteristics make a psychological treatment more or less likely to result in improvement .
-BACKGROUND	We have previously conducted a study of a newly developed internet-delivered cognitive behavioral therapy ( ICBT ) that emphasized exposure to IBS symptoms and IBS-related situations and reduced symptom-related avoidance .
-BACKGROUND	The study showed that the treatment led to improvement in IBS symptoms compared to a waiting list and that treatment gains were maintained over a 15-18 month follow-up period .
-BACKGROUND	The aim of the present study was to investigate several possible predictors of short - and long-term treatment outcome in terms of symptom improvement , based on data collected in the previously conducted treatment trial .
-METHODS	Demographics , comorbid psychological distress , IBS-related fear and avoidance behaviors , and IBS-related disability were investigated as predictors of treatment outcome in the sample consisting of 79 participants diagnosed with IBS who had undergone 10 weeks of ICBT .
-METHODS	Predictors that were significantly correlated with symptom levels at post-treatment and follow-up were entered into multiple regression analyses that controlled for pre-treatment symptom levels .
-RESULTS	There were measures within each domain , i.e. , comorbid psychological distress , IBS-related fear and avoidance behaviors , and IBS-related disability , with the exception of demographic data , that were correlated with the symptom levels at post-treatment and follow-up .
-RESULTS	However , when these were entered into a multiple regression analyses that controlled for pre-treatment levels , none remained a significant predictor of the post-treatment and follow-up symptomatic status .
-CONCLUSIONS	The study did not find any individual characteristics that made patients more or less likely to respond to the exposure-based ICBT .
-CONCLUSIONS	The finding that comorbid psychological distress did not predict outcome is in accordance with previous studies .
-CONCLUSIONS	Reliable predictors for response to any type of psychological treatment for IBS remain to be established .
-
-###24597283
-OBJECTIVE	To evaluate the effect of luteal phase progesterone support on pregnancy rates in women with polycystic ovary syndrome ( PCOS ) who were treated for clomiphene citrate-resistant anovulatory infertility with ovulation induction and intrauterine insemination ( OI / IUI ) .
-METHODS	This randomized study included 110 clomiphene citrate-resistant PCOS patients .
-METHODS	All patients underwent ovulation induction with recombinant follicle-stimulating hormone and intrauterine insemination , up to 3 cycles , and were randomized into 2 groups : ( 1 ) luteal support with progesterone or ( 2 ) a control group .
-METHODS	The main outcomes were clinical pregnancy rates and live birth rates per cycle .
-RESULTS	Demographic data were not different between the study and control groups .
-RESULTS	Cycle characteristics were found to be homogeneous between groups .
-RESULTS	A total of 38 pregnancies were achieved ( 15.5 % pregnancy rate per cycle ) .
-RESULTS	The clinical pregnancy rate and live birth rate per cycle in progesterone supported cycles were 18.9 % and 16.8 % , respectively .
-CONCLUSIONS	There might be a clinical benefit of luteal progesterone supplementation on OI/IUI cycles for women with PCOS .
-CONCLUSIONS	Although we did not reach a statistically significant difference between the 2 groups , luteal-supported cycles demonstrated a 6.7 % higher clinical pregnancy rate and 6.1 % higher live birth rate .
-
-###24489762
-BACKGROUND	Dementia-care mapping ( DCM ) is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes .
-BACKGROUND	Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes , we investigated differences in costs of care between DCM and usual care in nursing homes .
-METHODS	Dementia special care units were randomly assigned to DCM or usual care .
-METHODS	Nurses from the intervention care homes received DCM training , a DCM organizational briefing day and conducted the 4-months DCM-intervention twice during the study .
-METHODS	A single DCM cycle consists of observation , feedback to the staff , and action plans for the residents .
-METHODS	We measured costs related to health care consumption , falls and psychotropic drug use at the resident level and absenteeism at the staff level .
-METHODS	Data were extracted from resident files and the nursing home records .
-METHODS	Prizes were determined using the Dutch manual of health care cost and the cost prices delivered by a pharmacy and a nursing home .
-METHODS	Total costs were evaluated by means of linear mixed-effect models for longitudinal data , with the unit as a random effect to correct for dependencies within units .
-RESULTS	34 units from 11 nursing homes , including 318 residents and 376 nursing staff members participated in the cost analyses .
-RESULTS	Analyses showed no difference in total costs .
-RESULTS	However certain changes within costs could be noticed .
-RESULTS	The intervention group showed lower costs associated with outpatient hospital appointments over time ( p = 0.05 ) than the control group .
-RESULTS	In both groups , the number of falls , costs associated with the elderly-care physician and nurse practitioner increased equally during the study ( p < 0.02 ) .
-CONCLUSIONS	DCM is a cost-neutral intervention .
-CONCLUSIONS	It effectively reduces outpatient hospital appointments compared to usual care .
-CONCLUSIONS	Other considerations than costs , such as nursing homes ' preferences , may determine whether they adopt the DCM method .
-BACKGROUND	Dutch Trials Registry NTR2314 .
-
-###24832767
-BACKGROUND	Although catheter ablation of isthmus-dependent atrial flutter ( AFL ) is successful at eliminating the target arrhythmia , many patients subsequently experience new-onset atrial fibrillation ( AF ) .
-OBJECTIVE	The aim of this study was to determine whether AF can be prevented by prophylactic pulmonary vein ablation in patients with AFL .
-METHODS	A prospective , single-blind , randomized clinical trial in patients whose sole arrhythmia was AFL without AF was conducted .
-METHODS	Patients were randomized to cavotricuspid isthmus ablation alone or with concomitant pulmonary vein isolation .
-METHODS	All patients received an implantable cardiac monitor .
-RESULTS	Fifty patients completed the trial , and patients were well matched .
-RESULTS	Isthmus ablation was successful in all patients ; pulmonary vein isolation was successful in 25 ( 100 % ) randomized patients .
-RESULTS	Procedure ( P < .0001 ) and fluoroscopy ( P < .0001 ) times were longer in the combined ablation group .
-RESULTS	More patients in the isthmus ablation-only group experienced new-onset AF during follow-up ( 52 % vs. 12 % ; P = .003 ) .
-RESULTS	The 1-year AF burden also favored the combined ablation group compared with the isthmus ablation-only group ( 8.3 % vs. 4.0 % ; P = .034 ) .
-RESULTS	In the isthmus ablation-only group , 8 ( 32 % ) patients subsequently underwent another ablation for AF .
-RESULTS	The performance of pulmonary vein isolation and male sex were independent predictors of freedom from AF .
-CONCLUSIONS	In the PREVENT-AF Study I randomized clinical trial of patients in whom only typical AFL had been observed clinically , the addition of pulmonary vein isolation to cavotricuspid isthmus ablation resulted in a marked reduction of new-onset AF during clinical follow-up as assessed with a continuous implantable cardiac monitor .
-
-###24457144
-BACKGROUND	Severe acute pancreatitis is a life-threatening disease .
-BACKGROUND	Patients with peripancreatic necrotic infection often require surgical removal of necrotic infected tissue and a wide debridement will cause blood loss and worsen the condition .
-OBJECTIVE	To assess whether treatment with NovoSeven , a recombinant activated FVII ( rFVIIa ) , could improve coagulation function and therefore reduce blood loss , blood transfusion and all-cause mortality during necrosectomy in patients with infected necrosis secondary to severe acute pancreatitis .
-METHODS	Severe acute pancreatitis patients admitted to Nanjing Jinling Hospital for necrosectomy were enrolled and randomized to receive either standard treatment or standard treatment plus an intravenous infusion of rFVIIa ( 40g per kilogram of body weight per hour ) before operation .
-METHODS	The prospectively defined primary end points were perioperative coagulation parameters ( prothrombin time , activated partial thromboplastin time ) , blood transfusion unit and blood loss .
-METHODS	The secondary end points were operation time , ICU stay and all-cause mortality at 28days after the operation .
-RESULTS	A total of 64 patients were enrolled ( 31 in the rFVIIa group and 33 in the control group ) .
-RESULTS	Treatment with rFVIIa was associated with a reduction in operation time , red blood cell and fresh froze plasma transfusion , blood loss and prothrombin time compared to the control group ( p < 0.05 for all ) .
-RESULTS	Activated partial thromboplastin time and mortality were similar between the two groups ( P > 0.05 ) .
-CONCLUSIONS	Treatment with rFVIIa significantly improved the extrinsic coagulation function in patients with severe acute pancreatitis and was associated with decreased risk of bleeding .
-CONCLUSIONS	However , rFVIIa did not improve intrinsic coagulation or reduce over-cause mortality .
-BACKGROUND	ChiCTR-TRC-1300389 .
-
-###24422264
-OBJECTIVE	The aim is to determine , from the patient 's perspective , what constitutes a good hand-off procedure in the emergency department ( ED ) .
-OBJECTIVE	The secondary purpose is to evaluate what impact a formalized hand-off had on patient knowledge , throughput and customer service
-METHODS	This study used a randomized controlled clinical trial involving two unique hand-off approaches and a convenience sample .
-METHODS	The study alternated between the current hand-off process that documented the process but not specific elements ( referred to as the informal process ) to one using the IPASS the BATON process ( considered the formal process ) .
-METHODS	Consenting patients completed a 12-question validated questionnaire on how the process was perceived by patients and about their understanding why they waited in the ED .
-METHODS	Statistical analysis using SPSS calculated descriptive frequencies and t-tests .
-RESULTS	In total 107 patients were enrolled : 50 in the informal and 57 in the formal group .
-RESULTS	Most patients had positive answers to the customer survey .
-RESULTS	There were significant differences between formal and informal groups : recalling the oncoming and outgoing physician coming to the patient 's bed ( p = 0.000 ) , with more formal group recalling that than informal group patients ; the oncoming physician introducing him/herself ( p = 0.01 ) , with more from the formal group answering yes and the physician discussing tests and implications with formal group patients ( p = 0.02 ) .
-CONCLUSIONS	This study was done at an urban inner city ED , a fact that may have skewed its results .
-CONCLUSIONS	A comparison of suburban and rural EDs would make the results stronger .
-CONCLUSIONS	It also reflected a very high level of customer satisfaction within the ED .
-CONCLUSIONS	This lack of variance may have meant that the correlation between customer service and handoffs was missed or underrepresented .
-CONCLUSIONS	There was no codified observation of either those using the IPASS the BATON script or those using informal procedures , so no comparison of level and types of information given between the two groups was done .
-CONCLUSIONS	There could have been a bias of those attending who had internalized the IPASS the BATON procedures and used them even when they were assigned to the informal group .
-CONCLUSIONS	A hand off from one physician to the next in the emergency department is best done using a formalized process .
-CONCLUSIONS	IPASS the BATON is a useful tool for hand off in the ED in part because it involved the patient in the process .
-CONCLUSIONS	The formal hand off increased communication between patient and doctor as its use increased the patient 's opportunity to ask and respond to questions .
-CONCLUSIONS	The researchers evaluated an ED physician specific hand-off process and illustrate the value and impact of involving patients in the hand-off process .
-
-###24262683
-OBJECTIVE	To compare the efficacy of a shorter interval ( 24hours ) between misoprostol and mifepristone administration with that of the conventional dosing interval ( 48hours ) for second-trimester termination of pregnancy ( TOP ) .
-METHODS	This was a prospective randomized , controlled , open-label study of 98 healthy women opting for mid-trimester TOP .
-METHODS	The women were randomized to receive 200mg mifepristone orally , followed 24hours ( Group 1 ) or 48hours ( Group 2 ) later by misoprostol ( 800g , then 400g every 3hours ) .
-METHODS	The primary outcome measure was the percentage of successful abortions within 24hours .
-METHODS	Secondary outcome measures were the induction-to-abortion interval ( measured from misoprostol administration ) and the frequencies of complications and adverse effects .
-RESULTS	The rate of successful abortions was similar with the 24-hour and 48-hour dosing intervals ( 95.8 % and 93.6 % , respectively ; P = 0.38 ) .
-RESULTS	The mean induction-to-abortion interval was also comparable between the 2 groups ( 8.64.1 hours versus 8.73.9 hours ; P = 0.37 ) .
-RESULTS	Nulliparous women and women with a pregnancy duration of 16weeks or more had a longer induction-to-abortion interval in both groups .
-CONCLUSIONS	The 24-hour dosing interval between misoprostol and mifepristone administration seems to be as effective as the 48-hour dosing interval for second trimester TOP .
-CONCLUSIONS	Clinical Trial Registry India : CTRI/2011/05 / 001770 .
-
-###25357149
-OBJECTIVE	The effects of combined aerobic and resistance exercise training on central arterial stiffness and gait velocity in patients with chronic poststroke hemiparesis were investigated .
-METHODS	Twenty-six patients with chronic poststroke hemiparesis were randomly assigned to either the combined aerobic and resistance exercise group ( n = 14 ) or the control group ( n = 12 ) .
-METHODS	The exercise intervention group received a combined aerobic and resistance exercise training ( 1 hr/day , three times/week for 16 wks ) , whereas the control group received usual care .
-METHODS	Central arterial stiffness was determined by pulse wave velocity and augmentation index .
-METHODS	Gait velocity was assessed using the 6-min walk test , 10-m walk test , and the Timed Up-and-Go test .
-RESULTS	Patients in the exercise intervention group had greater improvement of mean pulse wave velocity ( P < 0.001 ) , augmentation index ( P = 0.048 ) , and gait velocity ( 6-min walk test , P < 0.001 ; 10-m walk test , P < 0.001 ) than did patients in the control group .
-RESULTS	Patients in the exercise intervention group also had greater improvements in physical fitness component ( grip strength , P < 0.001 ; muscular strength of upper and lower limbs , P < 0.027 ; flexibility , P < 0.001 ) when compared with control patients .
-CONCLUSIONS	The combined aerobic and resistance exercise program significantly reduced central arterial stiffness and increased gait velocity in patients with chronic poststroke hemiparesis .
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-###25542519
-OBJECTIVE	To evaluate whether levels of corneal subbasal nerve fiber length ( SNFL ) in dry eye disease ( DED ) could prognosticate the level of improvement in signs and symptoms after treatment .
-METHODS	Phase IV , double-masked , randomized clinical trial .
-METHODS	Sixty patients with meibomian gland dysfunction-associated DED and 27 age-matched controls .
-METHODS	Patients with DED were randomized to receive topical artificial tears , loteprednol etabonate 0.5 % , or loteprednol etabonate 0.5 % / tobramycin 0.3 % twice daily for 4 weeks .
-METHODS	At baseline , in vivo confocal microscopy of central cornea was performed in both eyes .
-METHODS	Patients with DED were divided into 2 subgroups : those with low baseline SNFL and those with near-normal baseline SNFL for this purpose ( the cutoff point : the mean SNFL in controls minus 2 standard deviations ) .
-METHODS	Clinical signs and symptoms at baseline and after 4 weeks of treatment were compared between the subgroups with low and near-normal SNFL for all therapeutic groups .
-METHODS	Symptom questionnaires , corneal fluorescein staining ( CFS ) , conjunctival staining with lissamine green , tear break-up time , Schirmer 's test , and SNFL .
-RESULTS	In patients with DED , baseline SNFL ( 17.065.78 mm/mm ( 2 ) ) was significantly lower than in controls ( 23.683.42 mm/mm ( 2 ) , P = 0.001 ) .
-RESULTS	In the artificial tear and loteprednol groups , although no significant improvement in any sign or symptom was noted in patients with low baseline SNFL ( < 16.84 mm/mm ( 2 ) ) , subjects with near-normal baseline SNFL ( 16.84 mm/mm ( 2 ) ) showed significant improvement in both symptoms and CFS score ( all P < 0.05 ) .
-RESULTS	In the loteprednol/tobramycin group , no significant change was evident for any sign or symptom in either subgroup of low or near-normal baseline SNFL .
-CONCLUSIONS	Significant improvements in CFS and patient symptomatology after DED treatment were evident only in the subgroup with near-normal corneal SNFL .
-CONCLUSIONS	Consideration of SNFL may assist in explaining the variability of patients ' response to DED therapy .
-
-###25876342
-OBJECTIVE	To evaluate the effect mechanism of warm acupuncture combined with auricular point sticking therapy and its efficacy on insomnia by monitoring the level of brain neurotransmitters in the insomnia patients .
-METHODS	One hundred and thirty patients with insomnia were randomized into an observation group and a control group , 65 cases in each one .
-METHODS	In the observation group , based on the treating principle of warming yang and benefiting qi , acupuncture was applied to Xinshu ( BL 15 ) , Pishu ( BL 20 ) , Shenshu ( BL 23 ) , Yaoyangguan ( GV 3 ) , Baihui ( GV 20 ) , Neiguan ( PC 6 ) and Shenmen ( HT 7 ) .
-METHODS	Warm acupuncture was supplemented at Xinshu ( BL 15 ) , Pishu ( BL 20 ) , Shenshu ( BL 23 ) and Yaoyangguan ( GV 3 ) .
-METHODS	The treatment was given once every day .
-METHODS	In the control group , estazolam tablets , 0.5 to 1 mg were prescribed for oral administration , 30 min before sleep at night .
-METHODS	The treatment of 14 days was taken as one session and 2 sessions were required in the two groups .
-METHODS	The encephal of luctuograph technology was used to observe the sleep quality and brain neurotransmitters before and after treatment in the two groups and the efficacy was compared between the two groups .
-RESULTS	The total effective rate was 83.1 % ( 54/65 ) in the observation group and 87.7 % ( 57/65 ) in the control group .
-RESULTS	The efficacy was similar between the two groups ( P > 0.05 ) .
-RESULTS	In the observation group , after treatment , 5-HT and GABA/Glu were all increased compared with those before treatment ( P < 0.05 , P < 0.01 ) and norepinephrine ( NE ) was reduced compared with that before treatment ( P < 0.05 ) .
-RESULTS	The level of each index did not change significantly before and after treatment in the control group ( all P > 0.05 ) .
-RESULTS	The regulations of 5-HT , GABA/Glu in the observation group were superior to those in the control group ( all P < 0.05 ) .
-CONCLUSIONS	The combined therapy of warm acupuncture and auricular point sticking method for warming yang and benefiting qi effectively improves brain neurotransmitters and essentially improves sleep quality of the patients with insomnia differentiated as yang deficiency pattern .
-
-###25149899
-OBJECTIVE	To compare long-term outcomes and retreatment rates for patients with Dupuytren disease who underwent needle aponeurotomy ( NA ) combined with a series of triamcinolone acetonide injections or underwent NA alone as part of a prior randomized controlled trial .
-METHODS	During this follow-up study , 44 of 47 participants in the original study were examined as needed between 6 and 53 months from their initial procedure .
-METHODS	Those who had not been reassessed within 18 months of the original NA were asked to return for follow-up .
-METHODS	The average total active extension deficit ( TAED ) of previously treated joints was compared between groups 7 to 12 , 13 to 24 , 25 to 36 , and 37 to 48 months following treatment .
-METHODS	Timing of retreatment ( if performed ) was recorded .
-RESULTS	Forty-four participants returned for assessment an average of 4.8 times over 53months .
-RESULTS	Mean TAED was significantly less in needle aponeurotomy triamcinolone injection patients at 6 months and between 13 and 24 months .
-RESULTS	Sixty-two percent of NA group patients and 30 % of needle aponeurotomy triamcinolone injection patients returned for a second treatment on the same digit ( s ) ( retreatment ) .
-RESULTS	This difference was not significant .
-RESULTS	Mean time to retreatment and mean TAED immediately prior to retreatment did not differ significantly between groups .
-RESULTS	Kaplan-Meier survival estimates demonstrated a significantly higher percentage of NA group patients expected to return for retreatment by 24 but not by 36 months .
-RESULTS	Younger age , more than one joint treated at the initial NA , and TAED severity throughout the follow-up period were associated with earlier retreatment .
-CONCLUSIONS	Serial triamcinolone injections combined with NA was associated with lower TAED for up to 24 months .
-CONCLUSIONS	A larger study would more accurately quantify the potential benefits of combining triamcinolone injections with NA for treatment of Dupuytren disease .
-METHODS	Therapeutic III .
-
-###24220099
-OBJECTIVE	Increasing levels of physical activity in mothers have long-term health benefits for the mother and family .
-OBJECTIVE	The study aimed to evaluate the effect of a six-month , physical activity RCT for mothers of young children .
-METHODS	Women were recruited via playgroups and randomly assigned to intervention ( n = 394 ) or control group ( n = 322 ) .
-METHODS	The intervention group received a six-month multi-strategy programme delivered via playgroups in Perth , Australia .
-METHODS	measures were mean minutes per week of moderate ( M ) and vigorous ( V ) intensity physical activity ( PA ) , and number of days/week of muscle strength exercises .
-RESULTS	The intervention had a significant effect on mean time for vigorous ( p = 0.008 ) , moderate ( p = 0.023 ) and total physical activity ( p = 0.001 ) when compared to the control group .
-RESULTS	The intervention group increased their vigorous activity by a mean of 24min/week , moderate activity by 23min/week and total physical activity by 72min/week .
-CONCLUSIONS	A relatively minimum home based intervention was able to demonstrate modest but statistically significant improvements in physical activity in a hard to reach group .
-CONCLUSIONS	These changes if maintained over a longer period are likely to improve the health of mothers and have a positive impact on their partners and children .
-CONCLUSIONS	Australian and New Zealand Clinical Trials Registry ACTRN12609000735257 .
-
-###25361992
-BACKGROUND	To present longitudinal changes in Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) scores during 25-week treatment with enzalutamide or placebo in men with progressive metastatic castration-resistant prostate cancer ( mCRPC ) after chemotherapy in the AFFIRM trial .
-METHODS	Patients were randomly assigned to enzalutamide 160 mg/day or placebo .
-METHODS	FACT-P was completed before randomization , at weeks 13 , 17 , 21 , and 25 , and every 12 weeks thereafter while on study treatment .
-METHODS	Longitudinal changes in FACT-P scores from baseline to 25 weeks were analyzed using a mixed effects model for repeated measures ( MMRM ) , with a pattern mixture model ( PMM ) applied as secondary analysis to address non-ignorable missing data .
-METHODS	Cumulative distribution function ( CDF ) plots were generated and different methodological approaches and models for handling missing data were applied .
-METHODS	Due to the exploratory nature of the analyses , adjustments for multiple comparisons were not made .
-METHODS	AFFIRM is registered with ClinicalTrials.gov , number NCT00974311 .
-RESULTS	The intention-to-treat FACT-P population included 938 patients ( enzalutamide , n = 674 ; placebo n = 264 ) with evaluable FACT-P assessments at baseline and 1 post-baseline assessment .
-RESULTS	After 25 weeks , the mean FACT-P total score decreased by 1.52 points with enzalutamide compared with 13.73 points with placebo ( P < 0.001 ) .
-RESULTS	In addition , significant treatment differences at week 25 favoring enzalutamide were evident for all FACT-P subscales and indices , whether analyzed by MMRM or PMM .
-RESULTS	CDF plots revealed differences favoring enzalutamide compared with placebo across the full range of possible response levels for FACT-P total and all disease - and symptom-specific subscales/indices .
-CONCLUSIONS	In men with progressive mCRPC after docetaxel-based chemotherapy , enzalutamide is superior to placebo in health-related quality-of-life outcomes , regardless of analysis model or threshold selected for meaningful response .
-BACKGROUND	NCT00974311 .
-
-###24345099
-BACKGROUND	Arterial access is a major site of bleeding complications after invasive coronary procedures .
-BACKGROUND	Among strategies to decrease vascular complications , the radial approach is an established one .
-BACKGROUND	Vascular closure devices provide more comfort to patients and decrease hemostasis and need for bed rest .
-BACKGROUND	However , the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications , requiring evidence through adequately designed randomized trials .
-BACKGROUND	The aim of this study is to compare the radial versus femoral approach using a vascular closure device for the incidence of arterial puncture site vascular complications among non-ST-segment elevation acute coronary syndrome patients submitted to an early invasive strategy .
-METHODS	ARISE is a national , multicenter , non-inferiority randomized clinical trial .
-METHODS	Two hundred patients with non-ST-segment elevation acute coronary syndrome will be randomized to either radial or femoral access using a vascular closure device .
-METHODS	The primary outcome is the occurrence of vascular complications at an arterial puncture site 30days after the procedure , including major bleeding , retroperitoneal hematoma , compartment syndrome , hematoma5cm , pseudoaneurysm , arterio-venous fistula , infection , limb ischemia , arterial occlusion , adjacent nerve injury or the need for vascular surgical repair .
-RESULTS	Enrollment was initiated in September 2012 , and until October 2013 91 patients were included .
-RESULTS	The inclusion phase is expected to last until the second half of 2014 .
-CONCLUSIONS	The ARISE trial will help define the role of a vascular closure device as a bleeding avoidance strategy in patients with NSTEACS .
-BACKGROUND	ClinicalTrials.gov identifier : NCT01653587 .
-
-###25865294
-OBJECTIVE	Preclinical studies indicate that oxytocin is anorexigenic and has beneficial metabolic effects .
-OBJECTIVE	Oxytocin effects on nutrition and metabolism in humans are not well defined .
-OBJECTIVE	It was hypothesized that oxytocin would reduce caloric intake and appetite and alter levels of appetite-regulating hormones .
-OBJECTIVE	Metabolic effects of oxytocin were also explored .
-METHODS	A randomized , placebo-controlled crossover study of single-dose intranasal oxytocin ( 24 IU ) in 25 fasting healthy men was performed .
-METHODS	After oxytocin/placebo , subjects selected breakfast from a menu and were given double portions .
-METHODS	Caloric content of food consumed was measured .
-METHODS	Visual analog scales were used to assess appetite , and blood was drawn for appetite-regulating hormones , insulin , and glucose before and after oxytocin/placebo .
-METHODS	Indirect calorimetry assessed resting energy expenditure ( REE ) and substrate utilization .
-RESULTS	Oxytocin reduced caloric intake with a preferential effect on fat intake and increased levels of the anorexigenic hormone cholecystokinin without affecting appetite or other appetite-regulating hormones .
-RESULTS	There was no effect of oxytocin on REE .
-RESULTS	Oxytocin resulted in a shift from carbohydrate to fat utilization and improved insulin sensitivity .
-CONCLUSIONS	Intranasal oxytocin reduces caloric intake and has beneficial metabolic effects in men without concerning side effects .
-CONCLUSIONS	The efficacy and safety of sustained oxytocin administration in the treatment of obesity warrants investigation .
-
-###25097273
-OBJECTIVE	Benzodiazepines ( BZDs ) are the first-line drugs in alcohol-withdrawal syndrome ( AWS ) .
-OBJECTIVE	Baclofen , a gamma-aminobutyric acidB ( GABAB ) agonist , controls withdrawal symptoms without causing significant adverse effects .
-OBJECTIVE	The objective of this study was to compare the cost-effectiveness of baclofen and chlordiazepoxide in the management of uncomplicated AWS .
-METHODS	This was a randomized , open label , standard controlled , parallel group study of cost-effectiveness analysis ( CEA ) of baclofen and chlordiazepoxide in 60 participants with uncomplicated AWS .
-METHODS	Clinical efficacy was measured by the Clinical Institute Withdrawal Assessment for alcohol ( CIWA-Ar ) scores .
-METHODS	Lorazepam was used as supplement medication if withdrawal symptoms could not be controlled effectively by the study drugs alone .
-METHODS	Both direct and indirect medical costs were considered and the CEA was analyzed in both patient 's perspective and third-party perspective .
-RESULTS	The average cost-effectiveness ratio ( ACER ) in patient 's perspective of baclofen and chlordiazepoxide was Rs .
-RESULTS	5,308.61 and Rs .
-RESULTS	2,951.95 per symptom-free day , respectively .
-RESULTS	The ACER in third-party perspective of baclofen and chlordiazepoxide was Rs .
-RESULTS	895.01 and Rs .
-RESULTS	476.29 per symptom-free day , respectively .
-RESULTS	Participants on chlordiazepoxide had more number of symptom-free days when compared with the baclofen group on analysis by Mann-Whitney test ( U = 253.50 , P = 0.03 ) .
-CONCLUSIONS	Both study drugs provided relief of withdrawal symptoms .
-CONCLUSIONS	Chlordiazepoxide was more cost-effective than baclofen .
-CONCLUSIONS	Baclofen was relatively less effective and more expensive than chlordiazepoxide .
-
-###25479146
-BACKGROUND	This study was aimed to assess the outcome of Ilioinguinal , Iliohypogastric block and wound infiltration with 0.75 % ropivacaine on pain perception , first analgesic request and hospital stay following inguinal Lichtenstein mesh repair .
-METHODS	This was a prospective , randomized , double-blind study with 60 patients undergoing inguinal hernioplasty under general anesthesia .
-METHODS	Patients were randomly allocated to one of the two groups by the sealed envelope method .
-METHODS	Group 1 ( n = 30 ) received nerve blocks and incision infiltration with 0.75 % ropivacaine while group 2 ( n = 30 ) received isotonic saline .
-METHODS	Postoperatively pain intensity , time of demand for the first analgesic and duration of hospital stay were assessed .
-RESULTS	Median Visual Analog Scale ( VAS ) score of group 1 was 4 ( high = 6 , low = 3 ) while for group 2 was 5.50 ( high = 8 , low = 4 ) and the p value was < 0.001 .
-RESULTS	Mean time for the demand of the first analgesic was prolonged from 1.191.05 h to 5.311.14 h with the p value of < 0.0005 , while the mean time of hospital stay was reduced from 22.53.30 h to 14.12.99 h with the p value of < 0.0005 .
-CONCLUSIONS	Preemptive analgesia with 0.75 % ropivacaine causes significant reduction in pain perception , request for an analgesic and hospital stay .
-CONCLUSIONS	Therefore it is advisable before inguinal hernioplasty .
-
-###24746570
-BACKGROUND	The use of intensity-modulated radiotherapy ( IMRT ) in breast cancer reduces clinician-assessed breast tissue toxicity including fibrosis , telangectasia and sub-optimal cosmesis .
-BACKGROUND	Patient reported outcome measures ( PROMs ) are also important as they provide the patient 's perspective .
-BACKGROUND	This longitudinal study reports on ( a ) the effect of forward planned field-in-field IMRT ( simple IMRT ) on PROMs compared to standard RT at 5 years after RT , ( b ) factors affecting PROMs at 5years after RT and ( c ) the trend of PROMs over 5 years of follow up .
-METHODS	PROMs were assessed at baseline ( pre-RT ) , 6 , 24 and 60 months after completion of RT using global health ( EORTC QLQ C30 ) and 4 breast symptom questions ( BR23 ) .
-METHODS	Also , 4 breast RT-specific questions were included at 6 , 24 and 60 months : change in skin appearance , firmness to touch , reduction in breast size and overall change in breast appearance since RT. .
-METHODS	The benefits of simple IMRT over standard RT at 5 years after RT were assessed using standard t-test for global health and logistic regression analysis for breast symptom questions and breast RT-specific questions .
-METHODS	Clinical factors affecting PROMs at 5 years were investigated using a multivariate analysis .
-METHODS	A repeated mixed model was applied to explore the trend over time for each of PROMs .
-RESULTS	( 89 % ) 727/815 , 84 % , 81 % and 61 % patients completed questionnaires at baseline , 6 , 24 and 60 months respectively .
-RESULTS	Patients reported worse toxicity for all four BR23 breast symptoms at 6 months , which then improved over time ( p < 0.0001 ) .
-RESULTS	They also reported improvement in skin appearance and breast hardness over time ( p < 0.0001 ) , with no significant change for breast shrinkage ( p = 0.47 ) and overall breast appearance ( p = 0.13 ) .
-RESULTS	At 5years , PROMs assessments did not demonstrate a benefit for simple IMRT over standard radiotherapy .
-RESULTS	Large breast volume , young age , baseline surgical cosmesis and post-operative infection were the most important variables to affect PROMs .
-CONCLUSIONS	This study was unable to demonstrate the benefits of IMRT on PROMs at 5years .
-CONCLUSIONS	PROMs are influenced by non-radiotherapy factors and surgical factors should be optimised to improve patients ' outcome .
-CONCLUSIONS	Only a small proportion of patients report moderate-severe breast changes post radiotherapy , with most PROMs improving over time .
-CONCLUSIONS	The difference in clinician assessment and PROMs outcome requires further investigation .
-
-###25644291
-BACKGROUND	Sacral nerve stimulation ( SNS ) is a well established therapy for faecal incontinence ( FI ) .
-BACKGROUND	Percutaneous tibial nerve stimulation ( PTNS ) is a newer , less invasive , treatment .
-BACKGROUND	The effectiveness and acceptability of these treatments have not been compared systematically .
-METHODS	An investigator-blinded randomized pilot trial of PTNS versus SNS with a parallel qualitative study was performed .
-METHODS	Quantitative clinical outcomes and qualitative data from patient interviews were collected for both interventions .
-RESULTS	Forty patients ( 39 women ; mean age 59 years ) met the eligibility criteria ; 23 were randomized to receive SNS and 17 to PTNS .
-RESULTS	Fifteen patients progressed to permanent SNS implantation and 16 received a full course of PTNS .
-RESULTS	Within-group effect sizes were marginally greater for SNS than for PTNS on available-case analysis .
-RESULTS	Mean ( s.d. ) FI episodes per week at baseline , and 3 and 6 months of follow-up were : 114 ( 120 ) , 40 ( 40 ) and 49 ( 69 ) respectively for SNS compared with 106 ( 112 ) , 58 ( 69 ) and 63 ( 69 ) for PTNS .
-RESULTS	Mean ( s.d. ) Cleveland Clinic Incontinence Score values at baseline , and 3 and 6 months were : 162 ( 30 ) , 111 ( 52 ) and 104 ( 56 ) for SNS versus 151 ( 27 ) , 117 ( 44 ) and 121 ( 52 ) for PTNS .
-RESULTS	Improvement of at least 50 per cent in FI episodes per week at 6 months was seen in 11 of 18 patients in the SNS group compared with seven of 15 in the PTNS group .
-RESULTS	Effect estimates for SNS with chronic implanted stimulation were larger ( 10 of 15 patients at 6 months ) .
-RESULTS	Disease-specific and generic quality-of-life improvements complemented clinical outcome data .
-RESULTS	Qualitative analysis of interview data suggested that both treatments had high acceptability amongst patients .
-CONCLUSIONS	In the short term , both SNS and PTNS provide some clinical benefit to patients with FI .
-CONCLUSIONS	Registration numbers : 2010-018728-15 and 10479 ( http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10479 ) .
-
-###25008392
-OBJECTIVE	To assess efficacy and safety of fulranumab , a fully human monoclonal antibody against nerve growth factor , in patients with diabetic peripheral neuropathic pain ( DPNP ) .
-METHODS	In this phase II , double-blind , placebo-controlled trial , patients with moderate to severe DPNP were randomized to treatments with fulranumab ( 1 , 3 , or 10 mg ) or placebo administered subcutaneously every 4 weeks .
-RESULTS	Because of early study termination ( clinical hold ) by the US Food and Drug Administration , 77 ( intent-to-treat ) of the planned 200 patients were enrolled .
-RESULTS	The primary endpoint , the mean reduction of average daily pain at week 12 compared with baseline , showed a positive dose-response relationship ( p = 0.014 , 1-sided ) ; the pair-wise comparison between the 10-mg group and placebo was significant ( unadjusted p = 0.040 , 2-sided ) .
-RESULTS	An exploratory responder analysis revealed that a greater proportion of patients in the 10-mg group reported 30 % reduction in the average DPNP intensity compared with placebo at week 12 ( p = 0.006 ) .
-RESULTS	Although not statistically significant , several secondary endpoints showed directionally similar results to the primary efficacy dose-response relationship .
-RESULTS	During the combined efficacy and safety extension phases , the top 3 treatment-emergent adverse events in the combined fulranumab group were arthralgia ( 11 % ) , edema peripheral ( 11 % ) , and diarrhea ( 9 % ) .
-RESULTS	No cases of joint replacement or death were reported .
-CONCLUSIONS	Despite early study termination , fulranumab treatment resulted in dose-dependent efficacy and was generally well tolerated .
-METHODS	This study provides Class I evidence that in patients with DPNP , fulranumab 10 mg reduces pain by 1.2 points on an 11-point scale compared with placebo .
-
-###24950985
-BACKGROUND	Angiogenesis is a valid target in the treatment of epithelial ovarian cancer .
-BACKGROUND	Trebananib inhibits the binding of angiopoietins 1 and 2 to the Tie2 receptor , and thereby inhibits angiogenesis .
-BACKGROUND	We aimed to assess whether the addition of trebananib to single-agent weekly paclitaxel in patients with recurrent epithelial ovarian cancer improved progression-free survival .
-METHODS	For this randomised , double-blind phase 3 study undertaken between Nov 10 , 2010 , and Nov 19 , 2012 , we enrolled women with recurrent epithelial ovarian cancer from 32 countries .
-METHODS	Patient eligibility criteria included having been treated with three or fewer previous regimens , and a platinum-free interval of less than 12 months .
-METHODS	We enrolled patients with a computerised interactive voice response system , and patients were randomly assigned using a permuted block method ( block size of four ) in a 1:1 ratio to receive weekly intravenous paclitaxel ( 80 mg/m ( 2 ) ) plus either weekly masked intravenous placebo or trebananib ( 15 mg/kg ) .
-METHODS	Patients were stratified on the basis of platinum-free interval ( 0 and 6 months vs > 6 and 12 months ) , presence or absence of measurable disease , and region ( North America , western Europe and Australia , or rest of world ) .
-METHODS	The sponsor , investigators , site staff , and patients were masked to the treatment assignment .
-METHODS	The primary endpoint was progression-free survival assessed in the intention-to-treat population .
-METHODS	The trial is registered with ClinicalTrials.gov , NCT01204749 , and is no longer accruing patients .
-RESULTS	919 patients were enrolled , of whom 461 were randomly assigned to the trebananib group and 458 to the placebo group .
-RESULTS	Median progression-free survival was significantly longer in the trebananib group than in the placebo group ( 72 months [ 58-74 ] vs 54 months [ 95 % CI 43-55 ] , respectively , hazard ratio 066 , 95 % CI 057-077 , p < 00001 ) .
-RESULTS	Incidence of grade 3 or higher adverse events was similar between treatment groups ( 244 [ 54 % ] of 452 patients in the placebo group vs 258 [ 56 % ] of 461 patients in the trebananib group ) .
-RESULTS	Trebananib was associated with more adverse event-related treatment discontinuations than was placebo ( 77 [ 17 % ] patients vs 27 [ 6 % ] , respectively ) and higher incidences of oedema ( 294 [ 64 % ] patients had any-grade oedema in the trebananib group vs 127 [ 28 % ] patients in the placebo group ) .
-RESULTS	Grade 3 or higher adverse events included ascites ( 34 [ 8 % ] in the placebo group vs 52 [ 11 % ] in the trebananib group ) , neutropenia ( 40 [ 9 % ] vs 26 [ 6 % ] ) , and abdominal pain ( 21 [ 5 % ] vs 22 [ 5 % ] ) .
-RESULTS	We recorded serious adverse events in 125 ( 28 % ) patients in the placebo group and 159 ( 34 % ) patients in the trebananib group .
-RESULTS	There was a difference of 2 % or less in class-specific adverse events associated with anti-VEGF therapy ( hypertension , proteinuria , wound-healing complications , thrombotic events , gastrointestinal perforations ) , except bleeding , which was more common in the placebo group than in the trebananib group ( 75 [ 17 % ] vs 46 [ 10 % ] ) .
-CONCLUSIONS	Inhibition of angiopoietins 1 and 2 with trebananib provided a clinically meaningful prolongation in progression-free survival .
-CONCLUSIONS	This non-VEGF anti-angiogenesis option for women with recurrent epithelial ovarian cancer should be investigated in other settings and in combination with additional agents .
-CONCLUSIONS	Although oedema was increased , typical anti-VEGF associated adverse events were not prominent .
-BACKGROUND	Amgen .
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-###24833043
-OBJECTIVE	A close correlation exists between positron emission tomography ( PET ) - determined histamine H1 - receptor occupancy ( H1 RO ) and the incidence of sedation .
-OBJECTIVE	Antihistamines with H1 RO < 20 % are classified as non-sedating .
-OBJECTIVE	The objective was to compare the H1 RO of bilastine , a second generation antihistamine , with that of hydroxyzine .
-METHODS	This randomized , double-blind , crossover study used PET imaging with [ ( 11 ) C ] - doxepin to evaluate H1 RO in 12 healthy males ( mean age 26.2 years ) , after single oral administration of bilastine ( 20mg ) , hydroxyzine ( 25mg ) or placebo .
-METHODS	Binding potentials and H1 ROs were calculated in five cerebral cortex regions of interest : frontal , occipital , parietal , temporal , insula .
-METHODS	Plasma bilastine concentrations , subjective sedation ( visual analogue scale ) , objective psychomotor performance ( digital symbol substitution test ) , physiological variables and safety ( adverse events , AEs ) , were also evaluated .
-RESULTS	The mean binding potential of all five regions of interest ( total binding potential ) was significantly greater with bilastine than hydroxyzine ( mean value 0.26 vs. 0.13 , P < 0.01 ; mean difference and 95 % CI -0.130 [ -0.155 , 0.105 ] ) .
-RESULTS	There was no significant difference between bilastine and placebo .
-RESULTS	Overall H1 RO by bilastine was significantly lower than that by hydroxyzine ( mean value -3.92 % vs. 53.95 % , P < 0.01 ; mean difference and 95 % CI 57.870 % [ 42.664 % , 73.075 % ] ) .
-RESULTS	There was no significant linear relationship between individual bilastine plasma concentrations and total binding potential values .
-RESULTS	No significant between-treatment differences were observed for sedation and psychomotor performance .
-RESULTS	Twenty-six non-serious AEs were reported .
-RESULTS	Sleepiness or sedation was not reported with bilastine but appeared in some subjects with hydroxyzine .
-CONCLUSIONS	A single oral dose of bilastine 20mg had minimal H1 RO , was not associated with subjective sedation or objective impairment of psychomotor performance and was devoid of treatment-related sedative AEs , thus satisfying relevant subjective , objective and PET criteria as a non-sedating antihistamine .
-
-###25100190
-BACKGROUND	The Whole Systems Demonstrator was a large , pragmatic , cluster randomised trial that compared telehealth with usual care among 3,230 patients with long-term conditions in three areas of England .
-BACKGROUND	Telehealth involved the regular transmission of physiological information such as blood glucose to health professionals working remotely .
-BACKGROUND	We examined whether telehealth led to changes in glycosylated haemoglobin ( HbA1c ) among the subset of patients with type 2 diabetes .
-METHODS	The general practice electronic medical record was used as the source of information on HbA1c .
-METHODS	Effects on HbA1c were assessed using a repeated measures model that included all HbA1c readings recorded during the 12-month trial period , and adjusted for differences in HbA1c readings recorded before recruitment .
-METHODS	Secondary analysis averaged multiple HbA1c readings recorded for each individual during the trial period .
-RESULTS	513 of the 3,230 participants were identified as having type 2 diabetes and thus were included in the study .
-RESULTS	Telehealth was associated with lower HbA1c than usual care during the trial period ( difference 0.21 % or 2.3 mmol/mol , 95 % CI , 0.04 % to 0.38 % , p = 0.013 ) .
-RESULTS	Among the 457 patients in the secondary analysis , mean HbA1c showed little change for controls following recruitment , but fell for intervention patients from 8.38 % to 8.15 % ( 68 to 66 mmol/mol ) .
-RESULTS	A higher proportion of intervention patients than controls had HbA1c below the 7.5 % ( 58 mmol/mol ) threshold that was targeted by general practices ( 30.4 % vs. 38.0 % ) .
-RESULTS	This difference , however , did not quite reach statistical significance ( adjusted odds ratio 1.63 , 95 % CI , 0.99 to 2.68 , p = 0.053 ) .
-CONCLUSIONS	Telehealth modestly improved glycaemic control in patients with type 2 diabetes over 12 months .
-CONCLUSIONS	The scale of the improvements is consistent with previous meta-analyses , but was relatively modest and seems unlikely to produce significant patient benefit .
-BACKGROUND	International Standard Randomized Controlled Trial Number Register ISRCTN43002091 .
-
-###24864199
-OBJECTIVE	To evaluate the effect of calorie restriction-induced weight loss with or without aerobic exercise on liver fat .
-METHODS	Thirty-three adults with visceral adiposity were divided into calorie restriction ( CR ; n = 18 ) or CR and aerobic exercise ( CR + Ex ; n = 15 ) groups .
-METHODS	Target energy intake was 25kcal/kg of ideal body weight .
-METHODS	The CR + Ex group had a targeted exercise time of 300min/wk or more at lactate threshold intensity for 12 weeks .
-RESULTS	Reductions in body weight ( CR , -5.3 0.8 kg ; CR + Ex , -5.1 0.7 kg ) , fat mass ( CR , -4.9 0.9 kg ; CR + Ex , -4.4 0.6 kg ) , and visceral fat ( CR , -24 5cm2 ; CR + Ex , -37 5cm2 ) were not statistically different between groups .
-RESULTS	Liver fat decreased significantly in both groups , with no difference between groups .
-RESULTS	Change in maximal oxygen uptake was significantly greater in the CR + Ex group than in the CR group ( CR , -0.7 0.7 mL/kg/min ; CR + Ex , 2.9 1.0 mL/kg/min ) .
-CONCLUSIONS	Both CR and CR + Ex resulted in an improved reduction in liver fat ; however , there was no additive effect of exercise training .
-
-###24773166
-BACKGROUND	One hypothesis suggests that the differential response to ondansetron - and serotonin-specific re-uptake inhibitors ( SSRIs ) may be due to a functional polymorphism of the 5 ' - HTTLPR promoter region in SLC6A4 , the gene that codes for the serotonin transporter ( 5-HTT ) .
-BACKGROUND	The LL 5 ' - HTTLPR genotype is postulated to be specifically sensitive to the effects of ondansetron with SS/SL 5 ' - HTTLPR genotypes sensitive to SSRIs .
-BACKGROUND	This study tests this hypothesis by matching nontreatment-seeking alcohol-dependent ( AD ) individuals with LL genotype to ondansetron and SS/SL genotypes to the SSRI sertraline , and mismatching them assessing naturalistic and bar-laboratory alcohol drinking .
-METHODS	Seventy-seven AD individuals were randomized to 1 of 2 counterbalanced arms to receive sertraline 200 mg/d or ondansetron 0.5 mg/d for 3 weeks followed by an alcohol self-administration experiment ( ASAE ) and then received placebo for 3 weeks followed by a second ASAE .
-METHODS	Individuals then received the alternate drug for 3 weeks followed by a third ASAE .
-METHODS	Drinks per drinking day ( DDD with drinks in standard drinking units ) for 7 days prior to each ASAE and milliliters consumed during each ASAE were the primary outcomes .
-RESULTS	Fifty-five participants completed the study .
-RESULTS	The genotype order interaction was significant , F ( 1 , 47 ) = 8.42 , p = 0.006 , for DDD .
-RESULTS	Three analyses of covariance were conducted for DDD during the week before each ASAE .
-RESULTS	Ondansetron compared to sertraline resulted in a significant reduction in DDD during the week before the first , F ( 1 , 47 ) = 7.64 , p = 0.008 , but not the third ASAE .
-RESULTS	There was no difference in milliliters consumed during each ASAE .
-CONCLUSIONS	This study modestly supports the hypothesis that ondansetron may reduce DDD in AD individuals with the LL genotype as measured naturalistically .
-CONCLUSIONS	By contrast , there was no support that ondansetron reduces drinking during the ASAEs or that sertraline reduces alcohol use in individuals who have SS/SL genotypes .
-CONCLUSIONS	We provide limited support that ondansetron may reduce drinking in nontreatment-seeking individuals with the LL genotype .
-
-###26024502
-OBJECTIVE	No interventions have yet been identified to reduce the risk of acute kidney injury in the setting of cardiac surgery .
-OBJECTIVE	To determine whether remote ischemic preconditioning reduces the rate and severity of acute kidney injury in patients undergoing cardiac surgery .
-METHODS	In this multicenter trial , we enrolled 240 patients at high risk for acute kidney injury , as identified by a Cleveland Clinic Foundation score of 6 or higher , between August 2013 and June 2014 at 4 hospitals in Germany .
-METHODS	We randomized them to receive remote ischemic preconditioning or sham remote ischemic preconditioning ( control ) .
-METHODS	All patients completed follow-up 30 days after surgery and were analyzed according to the intention-to-treat principle .
-METHODS	Patients received either remote ischemic preconditioning ( 3 cycles of 5-minute ischemia and 5-minute reperfusion in one upper arm after induction of anesthesia ) or sham remote ischemic preconditioning ( control ) , both via blood pressure cuff inflation .
-METHODS	The primary end point was the rate of acute kidney injury defined by Kidney Disease : Improving Global Outcomes criteria within the first 72 hours after cardiac surgery .
-METHODS	Secondary end points included use of renal replacement therapy , duration of intensive care unit stay , occurrence of myocardial infarction and stroke , in-hospital and 30-day mortality , and change in acute kidney injury biomarkers .
-RESULTS	Acute kidney injury was significantly reduced with remote ischemic preconditioning ( 45 of 120 patients [ 37.5 % ] ) compared with control ( 63 of 120 patients [ 52.5 % ] ; absolute risk reduction , 15 % ; 95 % CI , 2.56 % -27.44 % ; P = .02 ) .
-RESULTS	Fewer patients receiving remote ischemic preconditioning received renal replacement therapy ( 7 [ 5.8 % ] vs 19 [ 15.8 % ] ; absolute risk reduction , 10 % ; 95 % CI , 2.25 % -17.75 % ; P = .01 ) , and remote ischemic preconditioning reduced intensive care unit stay ( 3 days [ interquartile range , 2-5 ] ) vs 4 days ( interquartile range , 2-7 ) ( P = .04 ) .
-RESULTS	There was no significant effect of remote ischemic preconditioning on myocardial infarction , stroke , or mortality .
-RESULTS	Remote ischemic preconditioning significantly attenuated the release of urinary insulinlike growth factor-binding protein 7 and tissue inhibitor of metalloproteinases 2 after surgery ( remote ischemic preconditioning , 0.36 vs control , 0.97 ng/mL2/1000 ; difference , 0.61 ; 95 % CI , 0.27-0 .86 ; P < .001 ) .
-RESULTS	No adverse events were reported with remote ischemic preconditioning .
-CONCLUSIONS	Among high-risk patients undergoing cardiac surgery , remote ischemic preconditioning compared with no ischemic preconditioning significantly reduced the rate of acute kidney injury and use of renal replacement therapy .
-CONCLUSIONS	The observed reduction in the rate of acute kidney injury and the need for renal replacement warrants further investigation .
-BACKGROUND	German Clinical Trials Register Identifier : DRKS00005333 .
-
-###24969367
-BACKGROUND	Parasitological confirmation is now recommended for all cases of suspected malaria .
-BACKGROUND	The roll-out of rapid diagnostic tests ( RDTs ) is hoped to enable this goal in low resource settings through point of care testing .
-BACKGROUND	However , simply making RDTs available has not led to high uptake of the tests or adherence to results by clinicians , with malaria continuing to be overdiagnosed in many settings .
-BACKGROUND	We undertook to design an evidence-based intervention package that would be sufficient to support the introduction of RDTs at dispensaries in Tanzania , to be evaluated through the Targeting Artemisinin Combination Therapy ( TACT ) cluster randomised controlled trial .
-METHODS	We describe five steps in our intervention design : formative research , review of existing evidence and theory , a workshop to define the intervention approach and content and results of formative research , engagement with behaviour change theory and literature , detailed design of intervention materials and piloting and pretesting of intervention materials .
-METHODS	This involved fieldwork with a total of 19 health workers and 212 community members in northeast Tanzania .
-RESULTS	The formative research suggested that RDTs were a potential source of conflict in the health worker-patient interaction , but that health workers used various techniques to resolve this , including provision of antimalarial drugs for RDT-negative patients .
-RESULTS	Our reviews showed that evidence was mixed regarding the effectiveness of different methods and theories to support change in prescribing practice .
-RESULTS	Our design process is presented , drawing from this collective evidence .
-RESULTS	We describe the final TACT intervention package ( including interactive small group workshops , feedback text messages , motivational text messages and patient information leaflets and posters ) in terms of its programme theory and implementation theory .
-CONCLUSIONS	Our study suggests that evidence-based design of complex interventions is possible .
-CONCLUSIONS	The use of formative research to understand malaria overdiagnosis in context was central to the design of the intervention as well as empirical research to test materials and methods prior to implementation .
-CONCLUSIONS	The TACT interventions may be appropriate for other settings where clinicians face similar challenges with malaria diagnostics .
-BACKGROUND	NCT01292707 .
-
-###24606876
-BACKGROUND	Despite strong empirical support for the association between perceived food affordability and dietary intake amongst families with a lower socioeconomic position ( SEP ) , there is limited evidence of the most effective strategies for promoting more positive perceptions of healthy food affordability among this group .
-BACKGROUND	This paper reports findings from a pilot intervention that aimed to improve perceptions of healthy food affordability amongst mothers .
-RESULTS	Participants were 66 mothers who were the parents of children recruited from primary schools located in socioeconomically disadvantaged suburbs .
-RESULTS	Intervention group participants viewed a slideshow focussed on healthy snack food affordability that illustrated cheaper healthier alternatives to common snack foods as well as food budgeting tips and price comparison education .
-RESULTS	A mixed between-within ANCOVA was conducted to examine group differences in perceived affordability of healthy food across three time points .
-RESULTS	Results revealed no difference in perceived affordability of healthy food between the two groups at baseline whereas at post-intervention and follow-up , mothers in the intervention group perceived healthy food as more affordable than the control group .
-CONCLUSIONS	Focussing on education-based interventions to improve perceptions of healthy food affordability may be a promising approach that complements existing nutrition promotion strategies .
-
-###24746282
-BACKGROUND	In burn care , a well-acknowledged problem is the suboptimal scar outcome from skin grafted burn wounds .
-BACKGROUND	With the aim of improving this , we focused on a new technique : excision of the burn wound followed by primary closure , thereby using a skin-stretching device to stretch the adjacent healthy skin .
-BACKGROUND	The short - and long-term effect of Skin Stretch was compared to split skin grafting ( SSG ) in a randomized controlled trial .
-METHODS	Patients with burn wounds were randomized for SSG or primary wound closure using Skin Stretch .
-METHODS	Follow-up was performed at 3 and 12 months postoperatively .
-METHODS	The scar surface area was calculated and the scar quality was assessed , using subjective and objective measurement methods .
-RESULTS	No significant differences between the SSG and the Skin Stretch group were found for scar surface area .
-RESULTS	In the Skin Stretch group , a significant reduction of the surface area from 65.4 cm ( 2 ) ( 13.6-129 .1 ) to 13.4 cm ( 2 ) ( 3.0-36 .6 ) was found at 3 months ( p = 0.028 ) and at 12 months postoperatively ( 65.4 cm ( 2 ) ( 13.6-129 .1 ) to 33.0 cm ( 2 ) ( 8.9-63 .7 ) , p = 0.046 , Wilcoxon signed ranks test ) .
-CONCLUSIONS	Skin Stretch for primary closure of acute burn wounds is a suitable technique and can be considered for specific circumscript full-thickness burn wounds .
-CONCLUSIONS	However , future research should be performed to provide additional scientific evidence .
-
-###25426978
-OBJECTIVE	Adequate bowel preparation is an important step for an effective colonoscopy .
-OBJECTIVE	Polyethylene glycol solution ( Kleanprep ) and sodium picosulphate with a magnesium citrate solution ( Picoprep ) are bowel cleansing agents registered and available for this purpose .
-OBJECTIVE	So far , the results of studies comparing the effectiveness of bowel cleansing between the two agents are inconclusive .
-OBJECTIVE	This may be because of differences in administration regimes and subjective measurement of bowel cleansing.In this single-blinded randomized-controlled trial , the effectiveness of Kleanprep and Picoprep was examined using a split-dose regimen and an objective bowel cleansing score system .
-METHODS	One hundred and seventy-three consecutive patients referred for outpatient colonoscopy were included , the required number based on power analysis .
-METHODS	Eighty-eight patients received Kleanprep ; 85 received Picoprep .
-METHODS	The primary outcome was the effectiveness of bowel cleansing using the Boston Bowel Preparation Score .
-METHODS	The secondary outcome was patient tolerability measured using a questionnaire .
-METHODS	An intention-to-treat-analysis was carried out .
-RESULTS	The overall Boston Bowel Preparation Score between Kleanprep and Picoprep was not significantly different ( P = 0.182 ) .
-RESULTS	On reviewing segment scores , there were also no significant differences between Kleanprep and Picoprep .
-RESULTS	Patients using Picoprep scored significantly better on the aspects of convenience and flavour of the preparation agent compared with patients using Kleanprep ( P < 0.001 ) .
-RESULTS	Side effects such as nausea ( P = 0.011 ) , vomiting ( P = 0.001 ) , headache ( P = 0.003 ) and bloating ( P < 0.001 ) were experienced less significantly by patients using Picoprep .
-CONCLUSIONS	The present study did not find a difference in the effectiveness of bowel cleansing between Kleanprep and Picoprep .
-CONCLUSIONS	Both were found to be adequate cleansing agents .
-CONCLUSIONS	Picoprep was significantly better tolerated than Kleanprep .
-CONCLUSIONS	Therefore , we recommend Picoprep as a first-choice regimen for bowel preparation before colonoscopy .
-
-###24286245
-OBJECTIVE	Psychotherapy for depression emphasizes techniques that can help individuals regulate their moods .
-OBJECTIVE	The present study investigated the affective impact and electrocortical correlates of cognitive restructuring , delivered as a 90-minute psychotherapeutic microintervention in a dysphoric sample .
-METHODS	Participants ( N = 92 ) who reported either low or high levels of dysphoric symptoms were randomly assigned to the restructuring microintervention , a control intervention or a no-intervention condition .
-METHODS	We obtained recordings of event-related potentials ( ERPs ) as well as mood self-ratings during an experimental session immediately after the psychotherapeutic microintervention and the control intervention in which a set of negatively valenced pictures ( IAPS ) was presented with different instructions .
-RESULTS	Whereas the restructuring intervention group and the control intervention group reported both increases in positive and decreases in negative affect from pre - to post-intervention , the three groups differed significantly on ERP measures .
-CONCLUSIONS	Findings provide support for current models of mechanisms of action in cognitive therapies .
-
-###24418037
-OBJECTIVE	To determine whether postaurical subcutaneous injection of triamcinolone acetonide is effective for subjective tinnitus refractory to medical treatment .
-METHODS	A total of 100 adult patients with subjective tinnitus of cochlear origin were randomly assigned to receive postaurical subcutaneous.Injection of either triamcinolone acetonide ( n = 50 ) or saline solution ( n = 50 ) .
-METHODS	The treatment protocol comprised 5 injections , one per week for 5 weeks.Improvement was measured by tinnitus severity evaluation index evaluation scale , at baseline and one week after the last injection .
-METHODS	The follow-up period was 6 months .
-RESULTS	No significant difference existed between two groups regarding age , gender , pure tone average , pretreatment tinnitus intensity , tinnitus duration or hearing loss level tinnitus duration ( P = 0.316,0.685,0.839,0.682 and 0.881 respectively ) .
-RESULTS	No significant post-treatment changes in the tinnitus severity index ( experimental group = 52 % , control group = 44 % ) were observed in either group ( P = 0.724 ) .
-RESULTS	The most frequently encountered side effect was pain during injection .
-CONCLUSIONS	The postaurical subcutaneous injection of triamcinolone acetonide has no obvious benefit compared with placebo for subjective tinnitus of cochlear origin refractory to medical treatment .
-
-###25082363
-BACKGROUND	Multicentre radiotherapy clinical trials can incorporate quality assurance ( QA ) procedures for ensuring consistent application of the trial protocol in the planning , delivery and reporting of participant treatments .
-BACKGROUND	Subsequently detected variations from trial protocol have previously been shown to reduce treatment efficacy , although little has been shown for toxicity rates .
-BACKGROUND	The purpose of this study was to investigate the association of QA measures and protocol variations on toxicity incidence in the context of a prostate radiotherapy trial .
-METHODS	Using QA records from the TROG 03.04 RADAR trial , the impact of variations on gastrointestinal ( GI ) and genito-urinary ( GU ) toxicities was investigated .
-RESULTS	Protocol variation rates were lower than reported in previous studies , and showed little correlation with GI toxicity outcomes .
-RESULTS	Variations classified as ` major ' showed a non-significant trend for increased toxicity relative to those classified as ` minor ' .
-RESULTS	Results from a Level III phantom-based dosimetry study showed some correlation with GI toxicity , whereas ranking on a set-up accuracy study did not impact on toxicity .
-RESULTS	Toxicity in general increased with the number of participants accrued per centre , at odds with previous reports relating to disease progression , with a potential link to increases in low-mid-range rectal doses in the cohort from higher-accruing centres .
-RESULTS	No QA-related variables correlated with GU toxicities .
-CONCLUSIONS	Besides non-significant trends , minimal association was observed between QA variables and toxicity rates for the RADAR trial .
-CONCLUSIONS	The intention of the trial 's QA programme was to reduce treatment variations and minimise toxicity in the context of a relevantly advanced treatment approach .
-
-###24700598
-OBJECTIVE	The prevalence of vancomycin-associated nephrotoxicity ( VAN ) is reported to vary from 1.0-42 .6 % , with most data from critically ill patients .
-OBJECTIVE	Evaluation of VAN among internal medicine patients is lacking .
-OBJECTIVE	Our objectives were to determine the incidence , time-course , outcomes , and risk factors of VAN in adult internal medicine patients .
-METHODS	Retrospective cohort .
-METHODS	Tertiary care academic medical center .
-METHODS	A total of 125 adult internal medicine patients receiving vancomycin treatment with mean baseline creatinine clearance of 84.627.6 ml/min .
-METHODS	Vancomycin treatment for a minimum of 72hours .
-RESULTS	Nephrotoxicity , defined as an increase in serum creatinine of 0.5 mg/dl or 50 % above baseline ( whichever was larger ) , occurred in 17 ( 13.6 % ) of 125 patients .
-RESULTS	No patients with VAN progressed to Loss or End stage as defined by the RIFLE criteria .
-RESULTS	The incidence rate of VAN was 0.02 cases/day of vancomycin treatment .
-RESULTS	Nephrotoxicity developed at a median of 4.5 days ( interquartile range [ IQR ] 2.2-4 .9 ) peaked at 5.7 days ( IQR : 3.8-9 .6 ) , and resolved in 70.6 % of the cases within 16.5 days ( IQR : 6.0-17 .8 ) after onset .
-RESULTS	On multivariable logistic regression analysis , after controlling for hypotensive episodes , Charlson Comorbidity Index , and baseline creatinine clearance , concomitant use of piperacillin-tazobactam was associated with increased VAN ( adjusted odds ratio 5.36 , 95 % confidence interval 1.41-20 .5 ) .
-CONCLUSIONS	Vancomycin-associated nephrotoxicity is prevalent among internal medicine patients , with 5.36-fold higher odds if piperacillin-tazobactam is concomitantly administered .
-
-###25332247
-OBJECTIVE	To explore the prognostic and/or predictive value of human epidermal growth factor receptor 2 ( HER2 ) pathway-related biomarkers in the phase III CLEOPATRA study of pertuzumab plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel as first-line treatment for patients with HER2-positive metastatic breast cancer .
-METHODS	Mandatory tumor and serum samples were collected ( N = 808 ; 58 % to 99.8 % were assessable ) , and amphiregulin , betacellulin , epidermal growth factor ( EGF ) , transforming growth factor alpha , EGF receptor , HER2 , HER3 , insulin-like growth factor 1 receptor , PTEN , phosphorylated AKT , PIK3CA , CMYC , serum HER2 extracellular domain ( sHER2 ) , and FCR were assessed using appropriate assays .
-METHODS	Two types of correlations were investigated using univariable Cox regression : predictive effects ( qualitative association of biomarkers with pertuzumab progression-free survival [ PFS ] benefit ) and prognostic effects independent of treatment arm ( relationship of each biomarker to clinical outcome in both arms pooled ) .
-RESULTS	Pertuzumab consistently showed a PFS benefit , independent of biomarker subgroups ( hazard ratio < 1.0 ) , including estrogen receptor-negative and - positive subgroups .
-RESULTS	High HER2 protein , high HER2 and HER3 mRNA levels , wild-type PIK3CA , and low sHER2 showed a significantly better prognosis ( P < .05 ) .
-RESULTS	PIK3CA showed the greatest prognostic effect , with longer median PFS for patients whose tumors expressed wild-type versus mutated PIK3CA in both the control ( 13.8 v 8.6 months ) and pertuzumab groups ( 21.8 v 12.5 months ) .
-CONCLUSIONS	Through comprehensive prospective analyses , CLEOPATRA biomarker data demonstrate that HER2 is the only marker suited for patient selection for the trastuzumab plus pertuzumab-based regimen in HER2-positive metastatic breast cancer .
-CONCLUSIONS	HER2 , HER3 , and PIK3CA were relevant prognostic factors .
-
-###24459063
-BACKGROUND	The goal of this study was to investigate the effects of linagliptin compared with glimepiride on alpha and beta cell function and several vascular biomarkers after a standardized test meal .
-METHODS	Thirty-nine patients on metformin alone ( age , 647years ; duration of type 2 diabetes mellitus , 7.84.5 years , 27 male , 12 female ; HbA1c , 57.26.9 mmol/mol ; meanSD ) were randomized to receive linagliptin 5mg ( n = 19 ) or glimepiride ( n = 20 ) for a study duration of 12weeks .
-METHODS	Glucagon-like peptide 1 , blood glucose , insulin , intact proinsulin , glucagon , plasminogen activator inhibitor-1 ( PAI-1 ) , cyclic guanosinmonophosphat and asymetric dimethylarginin levels were measured in the fasting state and postprandial at 30-min intervals for a duration of 5h .
-METHODS	The areas under the curve ( AUC0-300min ) were calculated for group comparisons .
-RESULTS	HbA1c , fasting and postprandial glucose levels improved in both groups .
-RESULTS	An increase in postprandial insulin ( 225955984pmol/L * min ) , postprandial intact proinsulin ( 1359658pmol/L * min ) , postprandial glucagon ( 3171136pg/mL * min ) and postprandial PAI-1 levels ( 863467ng/mL * min ) could be observed during treatment with glimepiride , whereas treatment with linagliptin was associated with a decrease in postprandial insulin ( -80074204 pmol/L * min ) , intact proinsulin ( -1771426 pmol/L * min ) , postprandial glucagon ( -15971831 pg/mL * min ) and PAI-1 levels ( -410276 ng/mL * min ) .
-CONCLUSIONS	Despite an improvement in blood glucose control in both groups , linagliptin reduced postprandial insulin , proinsulin , glucagon and PAI-levels .
-CONCLUSIONS	These results indicate an improvement in postprandial alpha and beta cell function , as well as a reduced postprandial vascular risk profile during treatment with linagliptin .
-
-###25112009
-OBJECTIVE	To explore the feasibility and safety of dexmedetomidine combined with remifentanil for lower eyelid blepharoplasty .
-METHODS	50 patients undergoing lower eyelid blepharoplasty ASA I - II were randomly divided into 2 groups ( 25 in each group ) as observation group and control group .
-METHODS	Dexmedetomidine ( 0.3 microg x kg ( -1 ) x h ( -1 ) ) and remifentanil ( 0.05 microg x kg ( -1 ) x min ( -1 ) ) were used in observation group .
-METHODS	Local anesthesia by lidocaine ( 1 % ) combined with midazolam ( 0.04 mg/kg ) intravenous sedation were used in control group .
-METHODS	HR , mean arterial pressure ( MAP ) , heart rate ( HR ) , breathing rate ( RR ) , pulse oxygen saturation ( SpO2 ) change were monitored and recorded before and after the administration of the drug , as well as at the beginning of operation , during the operation , at the end of the operation , and 5 minutes after the operation .
-METHODS	Patients sedation degree was evaluated by Ramsay .
-METHODS	Operation time , recovery time , the incidence of adverse reactions , the satisfaction of patients and doctors were also recorded .
-RESULTS	Patients had no obvious difference of intraoperative MAP , RR , SpO2 , operation time and postoperative recovery time between the two groups ( P > 0.05 ) .
-RESULTS	Compared with control group , HR during the operation were decreased significantly [ ( 64.2 + / - 8.2 ) bpm , P < 0.05 ] in observation group .
-RESULTS	In control group , there were 18 cases of patients with agitation , but they endured the operation anyway .
-RESULTS	In observation group , 24 cases of patients underwent operation without agitation .
-RESULTS	The satisfaction of patients and the operation doctors ( 96 % ) in observation group were markedly higher than that in control group ( P < 0.05 ) .
-CONCLUSIONS	Dexmedetomidine combined with remifentanil is practical and safe .
-CONCLUSIONS	The effect of reducing HR should be noticed .
-
-###24659566
-BACKGROUND	This study assessed efficacy of clarithromycin `` long-term '' macrolide therapy as an adjunct to maintenance therapy with nasal corticosteroids to prevent recurrence of nasal polyps ( NP ) after functional endoscopic sinus surgery ( FESS ) .
-METHODS	A total of 66 patients with chronic rhinosinusitis and bilateral NP were randomized into 3 study arms , 22 patients in each arm .
-METHODS	After FESS , patients in the first and second groups were treated with clarithromycin 250 mg/day for 12 and 24 weeks , respectively , whereas patients in the third group did not receive any clarithromycin .
-METHODS	Patients in all 3 groups received maintenance therapy with mometasone furoate 400 g/day .
-METHODS	Patient assessment was conducted before the surgery and 6 , 12 , and 24 weeks after surgery , using a visual analogue scale ( VAS ) , 20-item SinoNasal Outcome Test ( SNOT-20 ) , acoustic rhinometry , rhinomanometry , saccharin transit time , nasal endoscopy , computed tomography ( CT ) of paranasal sinuses , and measurement of the level of eosinophil cationic protein ( ECP ) in their nasal secretions .
-RESULTS	The study confirmed efficacy of `` long-term '' macrolide therapy , resulting in significant improvement of all parameters except acoustic rhinometry and VAS in both clarithromycin groups as compared to the control .
-RESULTS	Concentration of ECP in the nasal secretions increased dramatically after surgery , then returned to baseline levels after 12 and 24 weeks of treatment with clarithromycin .
-RESULTS	In the control group , ECP level continued to increase and was significantly higher at the endpoint .
-RESULTS	Both groups with clarithromycin showed significantly better endoscopic and CT scores than the control group at the end point .
-CONCLUSIONS	`` Long-term '' low-dose clarithromycin 250 mg/day is able to control eosinophilic inflammation and prevent early relapse of NP after FESS .
-
-###25584431
-BACKGROUND	The occurrence of ventilator-associated pneumonia ( VAP ) is linked to the aspiration of contaminated pharyngeal secretions around the endotracheal tube .
-BACKGROUND	Tubes with cuffs made of polyurethane rather than polyvinyl chloride or with a conical rather than a cylindrical shape increase tracheal sealing .
-OBJECTIVE	To test whether using polyurethane and/or conical cuffs reduces tracheal colonization and VAP in patients with acute respiratory failure .
-METHODS	We conducted a multicenter , prospective , open-label , randomized study in four parallel groups in four intensive care units between 2010 and 2012 .
-METHODS	A cohort of 621 patients with expected ventilation longer than 2 days was included at intubation with a cuff composed of cylindrical polyvinyl chloride ( n = 148 ) , cylindrical polyurethane ( n = 143 ) , conical polyvinyl chloride ( n = 150 ) , or conical polyurethane ( n = 162 ) .
-METHODS	We used Kaplan-Meier estimates and log-rank tests to compare times to events .
-RESULTS	After excluding 17 patients who secondarily refused participation or had met an exclusion criterion , 604 were included in the intention-to-treat analysis .
-RESULTS	Cumulative tracheal colonization greater than 10 ( 3 ) cfu/ml at Day 2 was as follows ( median [ interquartile range ] ) : cylindrical polyvinyl chloride , 0.66 ( 0.58-0 .74 ) ; cylindrical polyurethane , 0.61 ( 0.53-0 .70 ) ; conical polyvinyl chloride , 0.67 ( 0.60-0 .76 ) ; and conical polyurethane , 0.62 ( 0.55-0 .70 ) ( P = 0.55 ) .
-RESULTS	VAP developed in 77 patients ( 14.4 % ) , and postextubational stridor developed in 28 patients ( 6.4 % ) ( P = 0.20 and 0.28 between groups , respectively ) .
-CONCLUSIONS	Among patients requiring mechanical ventilation , polyurethane and/or conically shaped cuffs were not superior to conventional cuffs in preventing tracheal colonization and VAP .
-CONCLUSIONS	Clinical trial registered with clinicaltrials.gov ( NCT01114022 ) .
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-###25178882
-BACKGROUND	To evaluate the effects of the lactic acid bacterium Lactobacillus salivarius on caries risk factors .
-METHODS	The study was performed in 64 healthy volunteers to evaluate the effects of L. salivarius-containing tablets on caries risk factors .
-METHODS	The participants were divided randomly into four groups , and took tablets containing L. salivarius WB21 , L. salivarius TI 2711 , Ovalgen DC ( antibody against glucosyltransferase from Streptococcus mutans ) , or xylitol .
-METHODS	Levels of mutans streptococci and lactobacilli , amount of salivary flow , salivary pH , and salivary buffering capacity were assessed before and after taking the tablets .
-METHODS	Subsequently , a short-term administration trial using L. salivarius WB21-containing tablets was performed in eight healthy volunteers .
-METHODS	The participants took L. salivarius WB21-containing tablets ( 2.0 10 ( 9 ) colony forming units/day ) for 2 weeks , and the numbers of mutans streptococci in saliva were counted .
-RESULTS	The levels of mutans streptococci seemed to decrease in the L. salivarius WB21 , TI 2711 , and Ovalgen DC groups compared to the xylitol group , with no significant differences between the groups .
-RESULTS	Lactobacilli levels significantly increased in the L. salivarius WB21 and TI 2711 groups compared to the other groups .
-RESULTS	Concerning salivary flow and salivary pH , no significant differences were observed between the groups .
-RESULTS	The salivary buffering capacity significantly increased in the L. salivarius TI 2711 group ( P = 0.003 ) and Ovalgen DC group ( P = 0.002 ) compared to the xylitol group .
-RESULTS	The short-term administration trial showed that the L. salivarius WB21-containing tablets significantly decreased the number of mutans streptococci ( P = 0.039 ) .
-CONCLUSIONS	L. salivarius-containing tablets were suggested to increase resistance to caries risk factors .
-BACKGROUND	UMIN000013160 ( registration date : February 14 , 2014 ) .
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-###25251749
-OBJECTIVE	To examine the relationships between elevated depression symptoms ( EDS ) or stress and weight loss in SHINE , a telephonic , primary-care based , translation of the Diabetes Prevention Program .
-METHODS	N = 257 adults with metabolic syndrome were randomized to individual ( IC ) or group ( CC ) phone participation .
-METHODS	Weight , depression , anti-depressant use ( ADMs ) , and stress ( baseline , 6 months , 1 and 2 years ) were assessed .
-METHODS	Univariate analyses used linear and logistic regression , t tests for continuous variables and exact tests for categorical variables .
-METHODS	Stratified analyses assessed modifiers of effects of depression/stress on weight loss .
-RESULTS	Approximately 35 % reported EDS , with no change over time .
-RESULTS	Approximately 28 % of all participants used ADMs .
-RESULTS	Participants with EDS had lower mean % weight loss and a smaller % who achieved 5 % weight loss .
-RESULTS	Participants with EDS were less likely to be `` completers '' ( 40.1 % vs. 61.5 % , P = 0.002 ) , coached ( 48.0 % vs. 60.7 % , P = 0.049 ) , or log diet/activity ( 19.4 % vs. 42.7 % , P < 0.001 ) , behaviors related to weight loss .
-RESULTS	Results were similar for high stress .
-RESULTS	ADM use had no independent effect on weight loss .
-CONCLUSIONS	Individuals with metabolic syndrome and EDS and/or high stress were less likely to lose significant weight .
-CONCLUSIONS	Pre-intervention depression and stress screening to intervene may improve weight loss .
-
-###24953046
-OBJECTIVE	This subanalysis aimed to clarify whether intensive lipid-lowering therapy with statins slows the progression of atherosclerosis in Japanese subjects under treatment for primary prevention of cardiovascular disease .
-METHODS	This was a subanalysis of the Justification for Atherosclerosis Regression Treatment ( JART ) Study .
-METHODS	We compared the efficacy of intensive lipid-lowering therapy and conventional therapy with respect to changes in the mean intima-media thickness ( IMT ) and serum lipid levels .
-METHODS	We also evaluated changes in the mean IMT over 24 months of treatment and assessed the relationship between these changes and reductions in the LDL-C levels using a post-hoc analysis .
-RESULTS	Intensive lipid-lowering therapy with rosuvastatin was associated with significantly smaller changes in the mean IMT and a greater reduction in the serum lipid levels in comparison to conventional therapy with pravastatin .
-RESULTS	The average net change in the mean IMT was 0.010 mm ( n = 121 ) at 12 months and -0.004 mm ( n = 56 ) at 24 months .
-RESULTS	A decrease in LDL-C was found to be associated with a smaller change in the mean IMT ( p = 0.0009 ; Jonckheere-Terpstra trend test ) .
-RESULTS	A greater reduction in serum LDL-C was found to be associated with a smaller change in the mean IMT .
-RESULTS	Similar associations were observed for the serum TC and non-HDL-C levels and LDL-C/HDL-C ratio .
-RESULTS	There were no notable differences in the incidence of serious adverse events among the LDL-C quartiles .
-CONCLUSIONS	Lowering the LDL-C level with intensive lipid-lowering therapy is associated with reduced changes in the IMT among Japanese subjects at moderate to high risk under treatment for primary prevention .
-CONCLUSIONS	Subjects suitable for primary prevention may receive cardiovascular benefits from intensive lipid-lowering therapy , in association with significantly slower IMT progression than that observed with conventional therapy .
-
-###24972936
-OBJECTIVE	Fluticasone propionate and nasal saline irrigation have been used in the treatment of sinonasal diseases for a long time .
-OBJECTIVE	Our study investigates the effect of the combination of large volume low pressure nasal saline irrigation and fluticasone propionate for the treatment of pediatric acute rhinosinusitis .
-METHODS	Ninety-one pediatric patients with acute rhinosinusitis were included in our study .
-METHODS	The patients were randomized into two groups .
-METHODS	The first group ( n = 45 ) was treated with standard therapy ( antibiotherapy + nasal decongestant ) for 2 weeks , the second group was treated with the large volume low pressure nasal saline + fluticasone propionate combination for 3 weeks .
-METHODS	The clinical scores , radiologic evaluations ( X-ray Waters view ) , peak nasal inspiratory flow ( PNIF ) measurements , total symptom scores and hematologic parameters ( WBC , CRP , ESR ) of the patients were evaluated and compared .
-RESULTS	There were no significant differences in between the two groups regarding age , gender , height and weight .
-RESULTS	Even though the clinical scores of Group 2 improved more rapidly , there were no significant differences in between groups regarding clinical scores by the 21st day .
-RESULTS	There were no significant differences in post treatment radiologic evaluations ( Waters graphy ) .
-RESULTS	Both groups had significant improvement of their post treatment PNIF values , yet the improvement was more marked in Group 2 than in Group 1 .
-RESULTS	The rhinorrhea , nasal congestion , throat itching and cough symptoms improved more rapidly in Group 2 than in Group 1 .
-RESULTS	Post-treatment nose itching and sneezing symptoms were significantly less in Group 2 .
-RESULTS	The values of hematologic parameters were significantly reduced at the end of the 3rd week in both groups .
-CONCLUSIONS	Our study is a first in investigating the combined use of large volume low pressure nasal saline and fluticasone propionate in acute pediatric rhinosinusitis , and the results reveal that the combination therapy was effective .
-CONCLUSIONS	Low pressure large volume nasal saline + fluticasone propionate combination can be employed as a new line of therapy for the treatment of pediatric acute rhinosinusitis , either by itself or combined with standard therapy .
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-###25380901
-BACKGROUND	Cyclosporine and tacrolimus ( TAC ) are the most potent immunosuppressants .
-BACKGROUND	TAC is considered less nephrotoxic , but may be an important factor in chronic graft dysfunction .
-BACKGROUND	The aim of the study was to evaluate kidney function and cardiovascular risk profile in 2 groups of low immunological risk kidney allograft recipients receiving 2 TAC dosages .
-METHODS	Patients were randomly assigned to 2 TAC-based treatments ( group I [ n = 14 ] , standard dose ; group II [ n = 15 ] , reduced dose ) .
-METHODS	Patient and graft survival , graft function , occurrence of cardiovascular events ( cardiac death , myocardial infarction , stroke ) , incidence of new-onset diabetes mellitus after transplantation , and cardiovascular risk factors were assessed over a 5-year period .
-RESULTS	Patient demographics and transplant characteristics were not statistically different between groups .
-RESULTS	TAC trough levels were significantly higher in group I for 24 months post transplant .
-RESULTS	Patient survival did not differ , but there were more acute rejection episodes and graft losses in group II .
-RESULTS	There were no significant differences in the rate of cardiac events .
-RESULTS	Graft function measured as serum creatinine levels and calculated glomerular filtration rate did not differ between groups .
-RESULTS	The same applies to new-onset diabetes mellitus after transplantation incidence .
-RESULTS	Office blood pressures were numerically higher in group I up to 24 months but this difference did not reach significance at any time .
-RESULTS	Similar results were obtained for serum lipids .
-CONCLUSIONS	Immunosuppression based on low doses of tacrolimus seems to be safe in the group of low immunological risk patients but in the 60-month follow-up does not offer any clear benefits in terms of potential nephrotoxicity or cardiovascular risk .
-
-###24470003
-OBJECTIVE	This randomized controlled trial examined the quality-of-life benefits of an expressive writing ( EW ) intervention for patients with renal cell carcinoma ( RCC ) and identified a potential underlying mechanism of intervention efficacy .
-METHODS	Patients ( N = 277 ) with stage I to IV RCC were randomly assigned to write about their deepest thoughts and feelings regarding their cancer ( EW ) or about neutral topics ( neutral writing [ NW ] ) on four separate occasions .
-METHODS	Patients completed the Center for Epidemiologic Studies Depression Scale ( CES-D ) , MD Anderson Symptom Inventory ( MDASI ) , Brief Fatigue Inventory ( BFI ) , Pittsburgh Sleep Quality Index ( PSQI ) , Medical Outcomes Study Short Form-36 ( SF-36 ) , and Impact of Event Scale ( IES ) at baseline and 1 , 4 , and 10 months after the intervention .
-RESULTS	The mean age of participants ( 28 % stage IV ; 41 % female ) was 58 years .
-RESULTS	Multilevel modeling analyses , using a Bonferroni-corrected = .021 for six outcomes adjusted for the correlation among outcomes , revealed that , relative to the NW group , patients in the EW group reported significantly lower MDASI scores ( P = .003 ) and higher physical component summary scores on the SF-36 ( P = .019 ) at 10 months after the intervention .
-RESULTS	Mediation analyses revealed that significant group differences for MDASI scores at 10 months were mediated by lower IES scores at 1 month after the intervention in the EW group ( P = .042 ) .
-RESULTS	No significant group differences were observed in the BFI , CES-D , PSQI , and mental component summary of the SF-36 .
-CONCLUSIONS	EW may reduce cancer-related symptoms and improve physical functioning in patients with RCC .
-CONCLUSIONS	Evidence suggests that this effect may occur through short-term improvements in cognitive processing .
-
-###24570979
-OBJECTIVE	To compare two different impression techniques for implants in totally edentulous patients .
-METHODS	A total of 38 patients had impressions taken both using plaster and splinted vinyl polysiloxane ( splinted-VPS ) .
-METHODS	Two casts per patient were generated and allocated as test ( plaster ) and control ( splinted-VPS ) cast groups according to a randomised cross-over design .
-METHODS	One of the two casts from each patient was randomly selected as master cast according to a parallelgroup design and used to fabricate the definitive prosthesis .
-METHODS	Outcome measures were implant and prosthetic success rates , complications , marginal bone level ( MBL ) changes , patient satisfaction , chair time required to take the impressions , inter-implant discrepancy between the casts , sulcus bleeding index ( SBI ) and plaque score ( PS ) .
-RESULTS	In total , 76 impressions were taken in 38 patients .
-RESULTS	Two plaster impressions failed .
-RESULTS	Furthermore , 38 computer-aided design/computer-assisted manufacturing screw-retained complete-arch prostheses were fabricated onto the master cast ( 18 from plaster and 20 from splinted-VPS impressions ) and the patients were followed up for 3 years after loading .
-RESULTS	No drop-out occurred and no implants or prostheses failed , accounting for a cumulative implant and prosthesis survival rate of 100 % over the 3-year post-loading period .
-RESULTS	Plaster impressions yielded significantly greater patient satisfaction and shorter chair time .
-RESULTS	The discrepancy between the casts was 0.055 0.067 mm ( P = 0.931 ) .
-RESULTS	Mixed model analysis revealed a significant main effect from both the implant number and the inter-implant distance , while no difference was found with regard to implant angulation .
-RESULTS	Five chip-off fractures of the porcelain veneer occurred in 5 of the 38 patients ( 3 in restorations fabricated onto the plaster cast group and 2 in the splinted-VPS cast group ) with no effect from the type of impression on the prosthetic success rate ( P = 0.331 ) .
-RESULTS	However , all of the patients were functionally and aesthetically satisfied with their prostheses .
-RESULTS	Furthermore , mean MBL , SBI and PS showed no significant differences ( P > 0.05 ) between the groups .
-CONCLUSIONS	The clinical outcome of plaster impressions for completely edentulous patients was found to be the same as that for splinted-VPS impressions .
-CONCLUSIONS	The intraoral pre-scan resin framework try-in can be avoided .
-CONCLUSIONS	Plaster impressions may be less time consuming and thus more comfortable for the patient , but sometimes may have to be repeated due to fractures .
-BACKGROUND	All materials used in this study were purchased by the authors and there were no commercial or institutional interests .
-
-###24819510
-METHODS	Prospective randomized single blind study .
-OBJECTIVE	To find out the incidence of deep vein thrombosis ( DVT ) in Indian acute spinal cord injury ( ASCI ) subjects with and without pharmacological prophylaxis .
-METHODS	Indian Spinal Injuries Centre .
-METHODS	Seventy four ASCI subjects were randomly divided into two groups with 37 subjects each : group I received no antithrombotic prophylaxis , and only physical measures like compression stockings were employed for prophylaxis , whereas group II received antithrombotic prophylaxis with low-molecular weight heparin ( LMWH ) along with physical measures as in group I. DVT was monitored through daily clinical assessment and doppler venous ultrasonography at 2 weeks .
-RESULTS	Out of 37 subjects in each group , eight ( 21.6 % ) developed DVT in group I and two ( 5.4 % ) in group II .
-RESULTS	The difference was significant ( P-value = 0.041 ) .
-RESULTS	Six out of eight subjects who developed DVT in group I were asymptomatic .
-RESULTS	There was no incidence of significant DVT-related complications including pulmonary embolism in any of the subjects .
-CONCLUSIONS	There is a significant incidence of DVT in Indian subjects with ASCI but definitely less than what has been reported in western literature .
-CONCLUSIONS	Pharmacological prophylaxis ( LMWH in this study ) significantly ( P = 0.041 ) decreases the incidence of DVT in subjects with ASCI .
-CONCLUSIONS	As there was no difference in the incidence of symptomatic DVT or related complications , a larger study would be required to conclude definitely on the role of pharmacological prophylaxis in the Indian population .
-
-###24837362
-OBJECTIVE	Describe the effects of conjugated estrogens/bazedoxifene ( CE/BZA ) , a new treatment for vasomotor symptoms ( VMS ) and osteoporosis prevention , on menopause-specific quality of life ( MSQOL ) across different patient population types in phase 3 clinical trials .
-METHODS	MSQOL was prospectively evaluated in 4 randomized , double-blind , placebo-controlled studies .
-METHODS	The populations studied included healthy , non-hysterectomized postmenopausal women with symptomatic VMS or vulvar-vaginal atrophy ( VVA ) and general postmenopausal women ( eligible regardless of symptoms ) .
-METHODS	Menopause-specific Quality of Life ( MENQOL ) questionnaire total and domain scores for CE 0.625 mg/BZA 20mg and CE 0.45 mg/BZA 20mg were evaluated and compared with established thresholds for clinically important differences ( CID ) .
-RESULTS	Significant improvements compared with placebo were found with both CE/BZA doses in MENQOL vasomotor domain ( -0.61 to -2.23 over 3-24 months ) and total scores ( -0.24 to -0.94 ) in the general and symptomatic VMS/VVA populations .
-RESULTS	Significant improvement compared with placebo in sexual domain ( -0.11 to -0.72 ) was observed with the higher dosage for all populations , and with the lower dosage in the VVA ( -0.71 at month 3 ) and general populations ( -0.4 at months 12 and 24 ) .
-RESULTS	Improvements in vasomotor domain exceeded the CID with both doses in symptomatic VMS populations and with the higher dosage in women with symptomatic VVA ; for total MENQOL , the CID was exceeded with the higher dose in symptomatic VMS populations .
-CONCLUSIONS	CE/BZA significantly improved overall and vasomotor-related MSQOL across populations of postmenopausal women with varying baseline symptom statuses .
-CONCLUSIONS	Women with greater menopausal symptoms at baseline were more likely to experience clinically meaningful changes .
-
-###24811183
-OBJECTIVE	Intradialytic hypotension ( IDH ) represents a common hemodialysis ( HD ) complication .
-OBJECTIVE	Blood volume tracking ( BVT ) is a tool regulating the relative blood volume changes and potentially reducing the occurrence of IDH .
-OBJECTIVE	The aim of this study was to evaluate the ability of BVT to reduce the staff workload associated to IDH .
-METHODS	Ten hypotension-prone HD patients were treated each with 39 conventional HD ( HD ) sessions and then switched to 39 HD sessions with BVT ( HD-BVT ) .
-METHODS	The staff interventions related to IDH were monitored by a trained staff .
-RESULTS	Dialysis sessions complicated by IDH and staff interventions were affected by BVT ( HD : 102 and 127 vs. HD-BVT : 57 and 59 , respectively , for both p < 0.001 ) .
-RESULTS	The time consumed by staff in IDH management was decreased by HD-BVT ( 1416 vs. 578 min , p < 0.001 ) .
-CONCLUSIONS	The effectiveness of BVT to reduce the frequency of IDH leads to a reduction of the dialysis staff workload with fewer staff interventions , allowing for major work-time saving .
-
-###24726635
-OBJECTIVE	To examine the impact of blood pressure control on hospital health resource utilization using data from the ECLIPSE trials .
-METHODS	Post-hoc analysis of data from 3 prospective , open-label , randomized clinical trials ( ECLIPSE trials ) .
-METHODS	Sixty-one medical centers in the United States .
-METHODS	Patients 18 years or older undergoing cardiac surgery .
-METHODS	Clevidipine was compared with nitroglycerin , sodium nitroprusside , and nicardipine .
-RESULTS	The ECLIPSE trials included 3 individual randomized open-label studies comparing clevidipine to nitroglycerin , sodium nitroprusside , and nicardipine .
-RESULTS	Blood pressure control was assessed as the integral of the cumulative area under the curve ( AUC ) outside specified systolic blood pressure ranges , such that lower AUC represents less variability .
-RESULTS	This analysis examined surgery duration , time to extubation , as well as intensive care unit ( ICU ) and hospital length of stay ( LOS ) in patients with AUC10 mmHgmin/h compared to patients with AUC > 10 mmHgmin/h .
-RESULTS	One thousand four hundred ten patients were included for analysis ; 736 patients ( 52 % ) had an AUC10 mmHgmin/h , and 674 ( 48 % ) had an AUC > 10 mmHgmin/h .
-RESULTS	The duration of surgery and ICU LOS were similar between groups .
-RESULTS	Time to extubation and postoperative LOS were both significantly shorter ( p = 0.05 and p < 0.0001 , respectively ) in patients with AUC10 .
-RESULTS	Multivariate analysis demonstrates AUC10 was significantly and independently associated with decreased time to extubation ( hazard ratio 1.132 , p = 0.0261 ) and postoperative LOS ( hazard ratio 1.221 , p = 0.0006 ) .
-CONCLUSIONS	Based on data derived from the ECLIPSE studies , increased perioperative BP variability is associated with delayed time to extubation and increased postoperative LOS .
-
-###24994842
-OBJECTIVE	We assessed the likelihood of 12-month seizure remission and treatment failure after failure of a first antiepileptic drug , and identified factors influencing these outcomes .
-METHODS	SANAD ( Standard and New Antiepileptic Drug ) was a randomized controlled trial comparing monotherapy with standard and new antiepileptic drugs .
-METHODS	Patients were followed up to study completion , even if they were switched from their randomized treatment .
-METHODS	After a first treatment failure , we assessed the probability of 12-month seizure remission and treatment failure .
-METHODS	Prognostic modeling identified predictors of these outcomes .
-RESULTS	Forty-four percent of patients in the SANAD trial had a first treatment failure .
-RESULTS	Seventy-five percent of these subsequently achieved 12-month remission by 6 years of follow-up .
-RESULTS	Significant prognostic factors included sex , age at treatment failure , time on randomized treatment at treatment failure , neurologic insult , total number of tonic-clonic seizures at treatment failure , reason for treatment failure , seizure type , and CT/MRI scan result .
-RESULTS	After a first treatment failure , young patients without tonic-clonic seizures , with a normal CT/MRI scan and failing their treatment because of unacceptable adverse events , had the highest likelihood of 12-month remission .
-RESULTS	Approximately 50 % of patients who failed a first treatment also failed their second .
-RESULTS	Significant prognostic factors included total number of tonic-clonic seizures at first treatment failure , reason for first treatment failure , and CT/MRI scan result .
-RESULTS	Patients with tonic-clonic seizures and failing because of inadequate seizure control had the highest risk of a second treatment failure .
-CONCLUSIONS	A high proportion of patients will achieve 12-month remission after a first treatment failure .
-CONCLUSIONS	Clinical factors can stratify patients according to likely outcome .
-
-###25878309
-BACKGROUND	Preoperative quantitative assessment of glenoid bone loss , selection of the glenoid component , and definition of its desired location can be challenging .
-BACKGROUND	Placement of the glenoid component in the desired location at the time of surgery is difficult , especially with severe glenoid pathological conditions .
-METHODS	Forty-six patients were randomly assigned to three-dimensional computed tomographic preoperative templating with either standard instrumentation or with patient-specific instrumentation and were compared with a nonrandomized group of seventeen patients with two-dimensional imaging and standard instrumentation used as historical controls .
-METHODS	All patients had postoperative three-dimensional computed tomographic metal artifact reduction imaging to measure and to compare implant position with the preoperative plan .
-RESULTS	Using three-dimensional imaging and templating with or without patient-specific instrumentation , there was a significant improvement achieving the desired implant position within 5 of inclination or 10 of version when compared with two-dimensional imaging and standard instrumentation .
-CONCLUSIONS	Three-dimensional assessment of glenoid anatomy and implant templating and the use of these images at the time of surgery improve the surgeon 's ability to place the glenoid implant in the desired location .
-
-###25788584
-BACKGROUND	In recent years , there has been a growing body of evidence indicating that replacing cholecalciferol ( vitamin D ) with 25-hydroxycholecalciferol [ 25 ( OH ) D ] through dietary supplementation enhances breast meat yield in broiler chickens .
-BACKGROUND	However , the underlying molecular mechanisms are still unknown .
-OBJECTIVE	We investigated the effect of 25 ( OH ) D on male broiler growth performance ( body weight , feed intake , feed conversion ratio , and breast meat yield ) , muscle protein synthesis , and the potential underlying molecular mechanisms .
-METHODS	Male Cobb 500 broiler chickens were divided into 4 body weight-matched groups and received a control diet with normal cholecalciferol ( 2760 IU/kg feed ) for 42 d , a diet with high concentrations of cholecalciferol ( 5520 IU/kg feed ) for 42 d , or a diet with 25 ( OH ) D ( 5520 IU/kg feed ) for 42 d ( HyD-42 ) .
-METHODS	A fourth group consumed the HyD-42 for 21 d and then control feed for 21 d ( HyD-21 ) ( n = 360 birds , 12 replicates/treatment ) .
-METHODS	Food and clean water were available for ad libitum consumption .
-METHODS	At the end of the 42-d experiment , protein turnover was measured by phenylalanine flooding dose .
-METHODS	Breast muscle tissues were collected and protein synthesis-related gene and protein expression were measured by real time polymerase chain reaction and Western blot , respectively .
-METHODS	Functional studies were performed in vitro with the use of a quail myoblast ( QM7 ) cell line .
-METHODS	QM7 cells were treated with 2 doses ( 1 nM and 10 nM ) of cholecalciferol or 25 ( OH ) D alone or in combination with 100 nM rapamycin , and cell proliferation was determined by cell proliferation assay .
-METHODS	Protein synthesis-related gene and protein expression were also determined .
-RESULTS	The HyD-42 increased 25 ( OH ) D circulating concentrations by 126 % ( P < 0.05 ) , enhanced breast meat yield ( P < 0.05 ) , and increased the fractional rate of protein synthesis by 3-fold ( P < 0.05 ) compared with the control diet .
-RESULTS	Molecular analyses revealed that breast muscle from chickens consuming the HyD-42 expressed significantly higher concentrations of vitamin D receptor ( VDR ) , phospho mechanistic target of rapamycin ( Ser2481 ) , phospho ribosomal P70 S6 kinase ( RPS6K ) ( Thr421/Ser424 ) , and antigen Ki-67 ( Ki67 ) compared with the other groups .
-RESULTS	In line with the in vivo data , in vitro functional studies showed that cells treated with 25 ( OH ) D for 24 h had increased VDR expression , and activated the mechanistic target of rapamycin ( mTOR ) / S6 kinase ( S6K ) pathway , enhanced Ki67 protein concentrations , and induced QM7 cell proliferation compared with untreated or cholecalciferol-treated cells .
-RESULTS	Blocking the mTOR pathway with rapamycin reversed these effects .
-CONCLUSIONS	Taken together , our findings provide evidence that the effects of 25 ( OH ) D on male broiler breast muscle are likely mediated through the mTOR-S6K pathway .
-
-###24751788
-OBJECTIVE	To assess the influence of an infusion of clonidine 1 g/kg/hr on fentanyl and midazolam requirement in ventilated newborns and infants .
-METHODS	Prospective , double-blind , randomized controlled multicenter trial .
-METHODS	Controlled trials.com/ISRCTN77772144 .
-METHODS	Twenty-eight level 3 German PICUs/neonatal ICUs .
-METHODS	Ventilated newborns and infants : stratum I ( 1-28 d ) , stratum II , ( 29-120 d ) , and stratum III ( 121 d to 2 yr ) .
-METHODS	Patients received clonidine 1 g/kg/hr or placebo on day 4 after intubation .
-METHODS	Fentanyl and midazolam were adjusted to achieve a defined level of analgesia and sedation according to Hartwig score .
-RESULTS	Two hundred nineteen infants were randomized ; 212 received study medication , 69.7 % were ventilated in the postoperative care and 30.3 % for other reasons .
-RESULTS	Primary endpoint : consumption of fentanyl and midazolam in the 72 hours following the onset of study medication ( main observation period ) in the overall study population .
-RESULTS	The confirmatory analysis of the overall population showed no difference in the consumption of fentanyl and midazolam .
-RESULTS	Explorative age-stratified analysis demonstrated that in stratum I ( n = 112 ) the clonidine group had a significantly lower consumption of fentanyl ( clonidine : 2.1 1.8 g/kg/hr , placebo : 3.2 3.1 g/kg/hr ; p = 0.032 ) and midazolam ( clonidine : 113.0 100.1 g/kg/hr , placebo : 180.2 204.0 g/kg/hr ; p = 0.030 ) .
-RESULTS	Strata II ( n = 43 ) and III ( n = 46 ) showed no statistical difference .
-RESULTS	Sedation and withdrawal-scores were significantly lower in the clonidine group of stratum I ( p < 0.001 ) .
-RESULTS	Frequency of severe adverse events did not differ between groups .
-CONCLUSIONS	Clonidine 1 g/kg/hr in ventilated newborns reduced fentanyl and midazolam demand with deeper levels of analgesia and sedation without substantial side effects .
-CONCLUSIONS	This was not demonstrated in older infants , possibly due to lower clonidine serum levels .
-
-###24668360
-OBJECTIVE	To investigate the effects of body awareness therapy on balance , mobility , balance confidence , and subjective health status in persons with stroke .
-METHODS	A pilot randomized controlled study with follow-up at one and 4-6 weeks after the intervention period .
-METHODS	Four primary healthcare centres in rebro County Council .
-METHODS	Persons more than six months post stroke , with walking ability of 100 metres .
-METHODS	The experimental intervention was body awareness therapy in groups once a week for eight weeks .
-METHODS	The controls were instructed to continue their usual daily activities .
-METHODS	Berg Balance Scale , Timed Up and Go Test , Timed Up and Go Test with a cognitive component , 6-minute walk test , and Timed-Stands Test .
-METHODS	Self-rated balance confidence was assessed using the Activities-specific Balance Confidence Scale , and subjective health status using the Short Form 36 ( SF-36 ) questionnaire .
-RESULTS	A total of 46 participants were included ( mean age 64 years ) ; 24 in the experimental intervention group and 22 in the control group .
-RESULTS	No significant differences in changed scores over time were found between the groups .
-RESULTS	Within the experimental intervention group , significant improvements over time was found for the tests Berg Balance Scale , Timed Up and Go cognitive , and 6-minute walk test .
-RESULTS	Within the control group , significant improvements over time were found for the Timed Up and Go Cognitive , and the Timed-Stands Test .
-CONCLUSIONS	In comparison to no intervention , no effects were seen on balance , mobility , balance confidence , and subjective health status after eight weeks of body awareness therapy .
-
-###24476555
-BACKGROUND	Major depressive disorder ( MDD ) imposes a considerable disease burden on individuals and societies .
-BACKGROUND	A large number of randomised controlled trials ( RCTs ) have shown the efficacy of Internet-based guided self-help interventions in reducing symptoms of depression .
-BACKGROUND	However , study quality varies considerably .
-BACKGROUND	The aim of this study is to evaluate the efficacy of a new Internet-based guided self-help intervention ( GET.ON Mood Enhancer ) compared to online-based psychoeducation in an investigator-blinded RCT .
-METHODS	A RCT will be conducted to compare the efficacy of GET.ON Mood Enhancer with an active control condition receiving online psychoeducation on depression ( OPD ) .
-METHODS	Both treatment groups will have full access to treatment as usual .
-METHODS	Adults with MDD ( n = 128 ) will be recruited and randomised to one of the two conditions .
-METHODS	Primary outcome will be observer-rated depressive symptoms ( HRSD-24 ) by independent assessors blind to treatment conditions .
-METHODS	Secondary outcomes include changes in self-reported depressive symptom severity , anxiety and quality of life .
-METHODS	Additionally , potential negative effects of the treatments will systematically be evaluated on several dimensions ( for example , symptom deteriorations , attitudes toward seeking psychological help , relationships and stigmatisation ) .
-METHODS	Assessments will take place at baseline , 6 and 12 weeks after randomisation .
-CONCLUSIONS	This study evaluates a new Internet-based guided self-help intervention for depression using an active control condition ( psychoeducation-control ) and an independent , blinded outcome evaluation .
-CONCLUSIONS	This study will further enhance the evidence for Internet-based guided self-help interventions for MDD .
-BACKGROUND	German Clinical Trial Registration ( DRKS ) : DRKS00005025 .
-
-###25042290
-OBJECTIVE	Novel strategies are needed to increase the uptake of voluntary medical male circumcision ( VMMC ) in sub-Saharan Africa and enhance the effectiveness of male circumcision as an HIV prevention strategy .
-OBJECTIVE	To determine whether small economic incentives could increase circumcision prevalence by addressing reported economic barriers to VMMC and behavioral factors such as present-biased decision making .
-METHODS	Randomized clinical trial conducted between June 22 , 2013 , and February 4 , 2014 , among 1504 uncircumcised men aged 25 to 49 years in Nyanza region , Kenya .
-METHODS	VMMC services were provided free of charge and participants were randomized to 1 of 3 intervention groups or a control group .
-METHODS	Participants in the 3 intervention groups received varying amounts of compensation conditional on undergoing circumcision at 1 of 9 study clinics within 2 months of enrollment .
-METHODS	Compensation took the form of food vouchers worth 200 Kenya shillings ( US $ 2.50 ) , 700 Kenya shillings ( US $ 8.75 ) , or 1200 Kenya shillings ( US $ 15.00 ) , which reflected a portion of transportation costs and lost wages associated with getting circumcised .
-METHODS	The control group received no compensation .
-METHODS	VMMC uptake within 2 months .
-RESULTS	Analysis of data for 1502 participants with complete data showed that VMMC uptake within 2 months was higher in the US $ 8.75 group ( 6.6 % ; 95 % CI , 4.3 % -9.5 % [ 25 of 381 ] ) and the US $ 15.00 group ( 9.0 % ; 95 % CI , 6.3 % -12.4 % [ 34 of 377 ] ) than in the US $ 2.50 group ( 1.9 % ; 95 % CI , 0.8 % -3.8 % [ 7 of 374 ] ) and the control group ( 1.6 % ; 95 % CI , 0.6 % -3.5 % [ 6 of 370 ] ) .
-RESULTS	In logistic regression analysis , the US $ 8.75 group had significantly higher VMMC uptake than the control group ( adjusted odds ratio [ AOR ] 4.3 ; 95 % CI , 1.7-10 .7 ) , as did the US $ 15.00 group ( AOR 6.2 ; 95 % CI , 2.6-15 .0 ) .
-RESULTS	Effect sizes for the US $ 8.75 and US $ 15.00 groups did not differ significantly ( P = .20 ) .
-CONCLUSIONS	Among uncircumcised men in Kenya , compensation in the form of food vouchers worth approximately US $ 8.75 or US $ 15.00 , compared with lesser or no compensation , resulted in a modest increase in the prevalence of circumcision after 2 months .
-CONCLUSIONS	The effects of more intense promotion or longer implementation require further investigation .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01857700 .
-
-###24811543
-BACKGROUND	Key factors limiting patients with lower extremity amputations to achieve maximal functional capabilities are falls and fear of falling .
-BACKGROUND	A task-specific fall prevention training program has successfully reduced prospectively recorded trip-related falls that occur in the community by the elderly .
-BACKGROUND	However , this program has not been tested in amputees .
-OBJECTIVE	In a cohort of unilateral transtibial amputees , we aimed to assess effectiveness of a falls prevention training program by ( 1 ) quantifying improvements in trunk control ; ( 2 ) measuring responses to a standardized perturbation ; and ( 3 ) demonstrating retention at 3 and 6 months after training .
-OBJECTIVE	Second , we collected patient-reported outcomes for balance confidence and falls control .
-METHODS	Fourteen male military service members ( 26 3 years ) with unilateral transtibial amputations and who had been walking without an assistive device for a median of 10 months ( range , 2-106 months ) were recruited to participate in this prospective cohort study .
-METHODS	The training program used a microprocessor-controlled treadmill designed to deliver task-specific postural perturbations that simulated a trip .
-METHODS	The training consisted of six 30-minute sessions delivered over a 2-week period , during which task difficulty , including perturbation magnitude , increased as the patient 's ability progressed .
-METHODS	Training effectiveness was assessed using a perturbation test in an immersive virtual environment .
-METHODS	The key outcome variables were peak trunk flexion and velocity , because trunk kinematics at the recovery step have been shown to be a determinant of fall likelihood .
-METHODS	The patient-reported outcomes were also collected using questionnaires .
-METHODS	The effectiveness of the rehabilitation program was also assessed by collecting data before perturbation training and comparing the key outcome parameters with those measured immediately after perturbation training ( 0 months ) as well as both 3 and 6 months posttraining .
-RESULTS	Mean trunk flexion angle and velocity significantly improved after participating in the training program .
-RESULTS	The prosthetic limb trunk flexion angle improved from pretraining ( 42 ; 95 % confidence interval [ CI ] , 38-47 ) to after training ( 31 ; 95 % CI , 25-37 ; p < 0.001 ) .
-RESULTS	Likewise , the trunk flexion velocity improved from pretraining ( 187/sec ; 95 % CI , 166-209 ) to after training ( 143/sec ; 95 % CI , 119-167 ; p < 0.004 ) .
-RESULTS	The results display a significant side-to-side difference for peak trunk flexion angle ( p = 0.01 ) with perturbations of the prosthetic limb resulting in higher peak angles .
-RESULTS	Prosthetic limb trips also exhibited significantly greater peak trunk flexion velocity compared with trips of the prosthetic limb ( p = 0.005 ) .
-RESULTS	These changes were maintained up to 6 months after the training .
-RESULTS	The peak trunk flexion angle of the subjects when the prosthetic limb was perturbed had a mean of 31 ( 95 % CI , 25-37 ) at 0 month , 32 ( 95 % CI , 28-37 ) at 3 months , and 30 ( 95 % CI , 25-34 ) at 6 months .
-RESULTS	Likewise , the peak trunk flexion velocity for the prosthetic limb was a mean of 143/sec ( 95 % CI , 118-167 ) at 0 months , 143/sec ( 95 % CI , 126-159 ) at 3 months , and 132 ( 95 % CI , 115-149 ) at 6 months .
-RESULTS	The peak trunk flexion angle when the nonprosthetic limb was perturbed had a mean of 22 ( 95 % CI , 18-24 ) at 0 months , a mean of 26 ( 95 % CI , 20-32 ) at 3 months , and a mean of 23 ( 95 % CI , 19-28 ) at 6 months .
-RESULTS	The peak trunk flexion velocity for the nonprosthetic limb had a mean of 85/sec ( 95 % CI , 71-98 ) at 0 months , a mean of 96 ( 95 % CI , 68-124 ) at 3 months , and 87/sec ( 95 % CI , 68-105 ) at 6 months .
-RESULTS	There were no significant changes in the peak trunk flexion angle ( p = 0.16 ) or peak trunk flexion velocity ( p = 0.35 ) over time after the training ended .
-RESULTS	The skill retention was present when either the prosthetic or nonprosthetic limb was perturbed .
-RESULTS	There were side-to-side differences in the trunk flexion angle ( p = 0.038 ) and trunk flexion velocity ( p = 0.004 ) .
-RESULTS	Perturbations of the prosthetic side resulted in larger trunk flexion and higher trunk flexion velocities .
-RESULTS	Subjects prospectively reported decreased stumbles , semicontrolled falls , and uncontrolled falls .
-CONCLUSIONS	These results indicate that task-specific fall prevention training is an effective rehabilitation method to reduce falls in persons with lower extremity transtibial amputations .
-
-###24277402
-OBJECTIVE	To explore the optimal postoperative nutritional support in elderly patients with gastric cancer .
-METHODS	One hundred and twenty elderly patients with gastric cancer undergoing radical gastrectomy were prospectively enrolled from January 2010 to March 2013 and randomly divided into total parenteral nutrition group ( TPN , n = 40 ) , early total enteral nutrition group ( TEN , n = 40 ) and enteral plus parenteral nutrition group ( EN+PN , n = 40 ) .
-METHODS	Clinical charasteristics including treatment tolerance , nutritional indexes , immune indexes , time to first flatus , incidence of postoperative infection and anastomotic leakage , were analyzed and compared .
-RESULTS	Treatment tolerance in EN+PN group ( 97.5 % , 39/40 ) was significantly higher than that in TPN group ( 82.5 % , 33/40 ) and TEN group ( 80.0 % , 32/40 ) ( both P < 0.05 ) .
-RESULTS	The nutritional indices , including prealbumin , albumin , transferrin , body mass index , and the incidence of anastomotic leakage were similar in the 3 groups ( P > 0.05 ) .
-RESULTS	The immune indices , including CD3 , CD4 , CD4/CD8 , were significantly reduced after operation in each group .
-RESULTS	However , they were significantly higher in EN+PN group and TEN group than those in TPN group ( both P < 0.05 ) .
-RESULTS	Furthermore , compared to the TPN group , the incidence of postoperative infection ( surgical site infection , pulmonary infection , abdominal infection ) was significantly lower and time to first flatus was significantly shorter in EN+PN group and TEN group .
-CONCLUSIONS	Early enteral nutrition after gastric cancer surgery is safe , simple and feasible .
-CONCLUSIONS	EN plus PN is the best way to administer postoperative nutritional support in elderly patients with gastric cancer .
-
-###25319061
-BACKGROUND	Integrins are involved in tumour progression and metastasis , and differentially expressed on colorectal cancer ( CRC ) cells .
-BACKGROUND	Abituzumab ( EMD 525797 ) , a humanised monoclonal antibody targeting integrin heterodimers , has demonstrated preclinical activity .
-BACKGROUND	This trial was designed to assess the tolerability of different doses of abituzumab in combination with cetuximab and irinotecan ( phase I ) and explore the efficacy and tolerability of the combination versus that of cetuximab and irinotecan in patients with metastatic CRC ( mCRC ) ( phase II part ) .
-METHODS	Eligible patients had KRAS ( exon 2 ) wild-type mCRC and had received prior oxaliplatin-containing therapy .
-METHODS	The trial comprised an initial safety run-in using abituzumab doses up to 1000 mg combined with a standard of care ( SoC : cetuximab plus irinotecan ) and a phase II part in which patients were randomised 1 : 1 : 1 to receive abituzumab 500 mg ( arm A ) or 1000 mg ( arm B ) every 2 weeks combined with SoC , or SoC alone ( arm C ) .
-METHODS	The primary end point was investigator-assessed progression-free survival ( PFS ) .
-METHODS	Secondary end points included overall survival ( OS ) , response rate ( RR ) and tolerability .
-METHODS	Associations between tumour integrin expression and outcomes were also assessed .
-RESULTS	Phase I showed that abituzumab doses up to 1000 mg were well tolerated in combination with SoC .
-RESULTS	Seventy-three ( arm A ) , 71 ( arm B ) and 72 ( arm C ) patients were randomised to the phase II part .
-RESULTS	Baseline characteristics were balanced .
-RESULTS	PFS was similar in the three arms : arm A versus SoC , hazard ratio ( HR ) 1.13 [ 95 % confidence interval ( CI ) 0.78-1 .64 ] ; arm B versus SoC , HR 1.11 ( 95 % CI 0.77-1 .61 ) .
-RESULTS	RRs were also similar .
-RESULTS	A trend toward improved OS was observed : arm A versus SoC , HR 0.83 ( 95 % CI 0.54-1 .28 ) ; arm B versus SoC , HR 0.80 ( 95 % CI 0.52-1 .25 ) .
-RESULTS	Grade 3 treatment-emergent adverse events were observed in 72 % , 78 % and 67 % of patients .
-RESULTS	High tumour integrin v6 expression was associated with longer OS in arms A [ HR 0.55 ( 0.30-1 .00 ) ] and B [ HR 0.41 ( 0.21-0 .81 ) ] than in arm C.
-CONCLUSIONS	The primary PFS end point was not met , although predefined exploratory biomarker analyses identified subgroups of patients in whom abituzumab may have benefit .
-CONCLUSIONS	The tolerability of abituzumab combined with cetuximab and irinotecan was acceptable .
-CONCLUSIONS	Further study is warranted .
-CONCLUSIONS	CLINICALTRIALS.GOV IDENTIFIER : NCT01008475 .
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-###24556231
-BACKGROUND	To investigate whether remote ischemic conditioning ( RIC ) can attenuate ischemic reperfusion injury ( IRI ) in recipients after kidney transplantation using donation after cardiac death .
-METHODS	Forty-eight recipients referred for kidney transplantation were recruited .
-METHODS	The paired recipients who received the kidneys from the same donor were randomly assigned ( one received RIC and the other did not ) .
-METHODS	RIC was induced by three 5-min cycles of brief repetitive ischemia and reperfusion by clamping the exposed external iliac artery .
-METHODS	Blood samples were withdrawn at hour 2 , hour 12 , days 1-7 , day 14 , and day 30 to measure serum creatinine level and estimated glomerular filtration rate after transplantation .
-METHODS	Urine samples were collected at hours 2 , 12 , 24 , and 48 to measure urine neutrophil gelatinase-associated lipocalin after transplantation .
-METHODS	Renal tissues were obtained at 30min for histologic changes after transplantation .
-RESULTS	There were no significant differences in clinical characteristics of the recipients and donors between RIC and control groups .
-RESULTS	The serum creatinine level was lower in the RIC group compared with that of the control group ( 12h , days 1-14 , P < 0.05 ; other P > 0.05 ) ; the estimated glomerular filtration rate was higher in the RIC group compared with that of the control group ( 12h , days 1-14 , P < 0.05 ; other P > 0.05 ) ; urine neutrophil gelatinase-associated lipocalin , an early marker of IRI , was lower in the RIC group at hours 2 , 12 , 24 , and 48 ( 2 h , 48h , P > 0.05 ; 12h , 24h , P < 0.05 ) compared with that of the control group .
-RESULTS	The graft pathology showed no differences between RIC and control groups .
-CONCLUSIONS	RIC enhanced the early recovery of renal function in recipients after kidneytransplantation .
-CONCLUSIONS	Our results provide a novel potential approach to attenuate transplantation-associated IRI .
-
-###25556539
-OBJECTIVE	To assess the effect of bilateral ultrasound-guided transversus abdominis plane block with ropivacaine compared with placebo as part of a multimodal analgesic regimen .
-METHODS	A randomized , double-blind , placebo-controlled trial following the CONSORT criteria .
-METHODS	Hvidovre University Hospital .
-METHODS	Forty-six women scheduled for total abdominal hysterectomy .
-METHODS	Women received either ropivacaine 0.75 % , 20 mL ( n = 24 ) or 0.9 % saline , 20 mL ( n = 24 ) in the transversus abdominis plane on each side .
-METHODS	Primary outcome was the 24-h postoperative morphine consumption .
-METHODS	Secondary outcomes were pain scores at rest and during coughing , postoperative nausea and vomiting at 1 , 2 , 4 , 6 , 8 , and 24 h , and time to first mobilization .
-RESULTS	There was no difference in the mean 24-h postoperative morphine consumption between the two groups ( p = 0.733 ) .
-RESULTS	The ropivacaine group had significantly lower median pain scores at 1 h ( p = 0.008 ) and 2 h ( p = 0.027 ) postoperatively at rest and at 8 h ( p = 0.028 ) during coughing .
-RESULTS	There was no significant difference in other secondary outcomes .
-CONCLUSIONS	There was no reduction in 24-h morphine consumption when using an ultrasound-guided transversus abdominis plane block in women undergoing total abdominal hysterectomy .
-CONCLUSIONS	As part of a multimodal regimen the transversus abdominis plane block showed some effect on pain scores at rest only in the early postoperative period .
-
-###25455873
-OBJECTIVE	To investigate the pharmacokinetics , safety , and analgesic efficacy of a novel topical formulation of lidocaine at insertion of an intrauterine device ( IUD ) .
-METHODS	Randomized controlled trial ; phase-I and phase-II studies .
-METHODS	University and public hospitals .
-METHODS	Women aged 18 years who wanted to receive an IUD .
-METHODS	Four women were parous in phase I ; all in phase II were nulliparous .
-METHODS	A single , 8.5-mL dose of lidocaine formulation ( SHACT ) was administered ( to the portio , cervix , and uterus ) with a specially designed applicator .
-METHODS	The phase-I study ( single-arm ) was designed for pharmacokinetic assessment ; the phase-II study ( randomized ) was intended for investigation of efficacy and safety .
-RESULTS	From the phase-I study ( 15 participants ) , mean pharmacokinetic values were : maximum plasma concentration : 351 205 ng/mL ; time taken to reach maximum concentration : 68 41 minutes ; and area under the concentration-time curve from 0 to 180 minutes : 717 421 ng * h/mL .
-RESULTS	Pain relief was observed with lidocaine vs. placebo in the phase-II study ( 218 women , randomized ) .
-RESULTS	Mean visual analog scale score for maximum pain during the first 10 minutes after IUD insertion was 36 % lower with lidocaine than with placebo ( 28.3 24.6 vs. 44.2 26.0 ) .
-RESULTS	Pain intensity was also significantly lower in the lidocaine group at 30 minutes .
-RESULTS	On average , 3 of 4 patients will have less pain with lidocaine than with placebo .
-RESULTS	Adverse events were similar in the placebo and lidocaine groups .
-RESULTS	No serious adverse events were reported .
-CONCLUSIONS	Lidocaine provides pain relief lasting for 30-60 minutes for women undergoing IUD insertion , without any safety concerns .
-CONCLUSIONS	Further studies of this lidocaine formulation , for IUD insertion and other clinical applications , are planned .
-BACKGROUND	2011-005660-18 and 2011-006220-20 ( EudraCT ) .
-
-###25840298
-OBJECTIVE	To compare laser in situ keratomileusis ( LASIK ) outcomes between 2 femtosecond lasers for flap creation in the treatment of myopia up to 1 year .
-METHODS	University eye clinic .
-METHODS	Prospective randomized eye-to-eye study .
-METHODS	Consecutive myopic patients were treated with wavefront-guided LASIK .
-METHODS	One eye had a flap created by the Intralase FS 60 kHz femtosecond laser , and the fellow eye was treated with the Intralase iFS 150 kHz femtosecond laser .
-METHODS	Eyes were randomized according to ocular dominance .
-METHODS	Evaluations included measurement of uncorrected distance visual acuity ( UDVA ) , corrected distance visual acuity , contrast sensitivity and wavefront aberrometry .
-RESULTS	The study enrolled 122 eyes of 61 patients .
-RESULTS	The mean preoperative spherical equivalent refraction was -4.62 diopters ( D ) 2.32 ( SD ) and -4.66 2.30 D in the 150 kHz group and 60kHz group , respectively .
-RESULTS	Patients preferred the 150 kHz laser to the 60 kHz laser intraoperatively ( 52.5 % versus 26.2 % ) ( P = .005 ) .
-RESULTS	One week postoperatively , UDVA was 20/16 or better in 85.2 % in the 150 kHz group and 70.5 % in the 60 kHz group ; the difference was statistically significant ( P < .05 ) .
-RESULTS	At 12 months , there were no significant differences in refractive outcomes or higher-order aberrations between the 2 groups .
-CONCLUSIONS	Flap creation with the 150 kHz system and the 60 kHz system resulted in excellent LASIK outcomes .
-CONCLUSIONS	Intraoperatively , patients preferred the 150 kHz system , which yielded better UDVA in the early postoperative period .
-CONCLUSIONS	There were no significant differences at 1 year between the 2 laser systems .
-BACKGROUND	Proprietary or commercial disclosures are listed after the references .
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-###24494291
-OBJECTIVE	To observe the clinical analgesic efficacy and the relation between clinical analgesic effect and duration of effect of two acupuncture methods of Longhu Jiaozhan ( fight of dragon and tiger , an acupuncture reinforcing and reducing manipulation characterized with nine counterclockwise and six clockwise rotations ) and even manipulations .
-METHODS	Sixty-two patients with primary dysmenorrhea were randomly divided into an observation group ( 32 cases ) and a control group ( 30 cases ) .
-METHODS	The observation group was applied with Longhu Jiaozhan manipulation , while the control group was applied with even manipulation .
-METHODS	Acupuncture treatment was given on both of the groups since onset of the pain .
-METHODS	The score of the visual analogue scale ( VAS ) of the 2 groups was observed at different times .
-METHODS	And 8 VAS values were recorded at the point right before acupuncture , needle remaining of 5 min , 10 min , 20 min and 30 min as well as and 30 min , 60 min , 120 min after needle withdrawal .
-METHODS	Comparison was made on differences between the 2 groups .
-RESULTS	Comparison with the same group before acupuncture showed that the VAS difference of the time from needling remaining of 5 min to 120 min after acupuncture were all with statistic significance ( all P < 0.01 ) .
-RESULTS	The score of VAS of needle remaining for 20 min and 30 min of the observation group was without significant difference ( P > 0.05 ) .
-RESULTS	The score of VAS value of needle remaining for 20 min and 30 min of the control group was with significant difference ( P < 0.01 ) .
-RESULTS	Comparison of the VAS scores before the treatment and the scores of the 2nd menstrual cycle were found with significant difference ( P < 0.01 ) .
-RESULTS	The VAS score of 2nd menstrual cycle was ( 28.73 + / - 16.15 ) in the observation group , which was better than ( 46.93 + / -12.18 ) in the control group ( P < 0.001 ) .
-RESULTS	Comparison of the VAS score of the two groups at 5 min r emaining of the needle was without statistic significance between two groups ( P > 0.05 ) .
-RESULTS	However , the VAS impairment magnitude difference at that moment was with statistic significance ( P < 0.01 ) .
-RESULTS	From the time of needle remaining for 10 min , 20 min , 30 min until 120 min after needling , the differences of the VAS scores and impairment range were all with statistic significance ( all P < 0.01 ) .
-RESULTS	The effects of the two acupuncture techniques could both be maintained up to 2 hours after needling .
-CONCLUSIONS	Both methods of acupuncture have immediate and long-term analgesic effect in a certain degree on primary dysmenorrhea .
-CONCLUSIONS	However , compared with the control group , the advantage of analgesic effect in the observation group is significantly superior .
-CONCLUSIONS	20 min needling remaining can reach the best analgesic effect .
-
-###24720686
-BACKGROUND	Our randomized controlled trial ( The BETTER Trial ) found that training a clinician to become a Prevention Practitioner ( PP ) in family practices improved chronic disease prevention and screening ( CDPS ) .
-BACKGROUND	PPs were trained on CDPS and provided prevention prescriptions tailored to participating patients .
-BACKGROUND	For this embedded qualitative study , we explored perceptions of this new role to understand the PP intervention .
-METHODS	We used grounded theory methodology and purposefully sampled participants involved in any capacity with the BETTER Trial .
-METHODS	Two physicians and one coordinator in each of two cities ( Toronto , Ontario and Edmonton , Alberta ) conducted eight individual semi-structured interviews and seven focus groups .
-METHODS	We used an interview guide and documented research activities through an audit trail , journals , field notes and memos .
-METHODS	We analyzed the data using the constant comparative method throughout open coding followed by theoretical coding .
-RESULTS	A framework and process involving external and internal practice facilitation using the new role of PP was thought to impact CDPS .
-RESULTS	The PP facilitated CDPS through on-going relationships with patients and practice team members .
-RESULTS	Key components included : 1 ) approaching CDPS in a comprehensive manner , 2 ) an individualized and personalized approach at multiple levels , 3 ) integrated continuity that included linking the patients and practices to CPDS resources , and 4 ) adaptability to different practices and settings .
-CONCLUSIONS	The BETTER framework and key components are described as impacting CDPS through a process that involved a new role , the PP .
-CONCLUSIONS	The introduction of a novel role of a clinician within the primary care practice with skills in CDPS could appropriately address gaps in prevention and screening .
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-###25845225
-OBJECTIVE	To observe the therapeutic effect of body acupuncture combined with auricular acupressure for treatment of menstrual headache of hyperactivity of `` liver fire '' .
-METHODS	A total of 85 menstrual headache patients with hyperactivity of `` liver-fire '' were randomly divided into control group ( n = 42 ) and treatment group ( n = 43 ) .
-METHODS	Patients of the control group were treated by oral administration of Flunarizine Hydrochloride Capsules ( Sibelium , 5 mg/time , twice daily ) for 5 days beginning at the headache attack in the first menstrual cycle , and for two weeks ( except weekends ) in the second and third menstrual cycles .
-METHODS	Patients of the treatment group were treated by manual acupuncture stimulation of body acupoints Baihui ( GV 20 ) , Fengchi ( GB 20 ) , Sanyinjiao ( SP 6 ) , Taichong ( LR 3 ) , Xiaxi ( GB 43 ) , Taiyang ( EX-HN 5 ) , Hanyan ( GB 4 ) , Xuanlu ( GB 5 ) and Shuaigu ( GB 8 ) beginning from the headache attack , and otopoint-pellet pressure of otopoints unilateral Endocrine , Ovaries , Shenmen , Cortex , Liver , Spleen and Kidney ( beginning 5 days before menstrual onset ) and bilateral Shenmen , Nie , Liver , Gallbladder , Subcortex and Jiaogan during headache attack .
-METHODS	Clinical symptom scores were assessed according to the `` Guiding Principles for Clinical Research on New Chinese Herbal Drugs '' issued by the Chinese Ministry of Health .
-RESULTS	After the treatment , of the 42 and 43 cases in the control and treatment groups , 9 ( 21.43 % ) and 20 ( 46.51 % ) were cured , 12 ( 28.57 % ) and 14 ( 32.56 % ) had a marked improvement , 13 ( 30.95 % ) and 7 ( 16.28 % ) were effective , 8 ( 19.05 % ) and 2 ( 4.65 % ) invalid , with the effective rates being 80.95 % and 95.35 % , respectively .
-RESULTS	The curative effect of the treatment group was significantly better than that of the control group ( P < 0.05 ) .
-RESULTS	The symptom score and VAS score after the treatment and 3 months post-treatment in the treatment group were significantly lower than those of the control group ( P < 0.01 ) .
-RESULTS	The headache scores and VAS scores were significantly reduced following the treatment and 3 months after the treatment in both control and treatment groups ( P < 0.01 ) .
-RESULTS	After the treatment for 2-3 therapeutic courses , the headache attack duration during menstruation was markedly and gradually shortened in both groups ( P < 0.01 ) , and therapeutic effect of the treatment group was significantly better than that of the control group ( P < 0.01 ) .
-CONCLUSIONS	Body acupuncture combined with auricular acupressure treatment can effectively relieve menstrual headache in menstrual women with hyperactivity of `` liver fire '' .
-
-###25007392
-BACKGROUND	Interleukin-17A is considered to be central to the pathogenesis of psoriasis .
-BACKGROUND	We evaluated secukinumab , a fully human anti-interleukin-17A monoclonal antibody , in patients with moderate-to-severe plaque psoriasis .
-METHODS	In two phase 3 , double-blind , 52-week trials , ERASURE ( Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis ) and FIXTURE ( Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens to Determine Efficacy in Psoriasis ) , we randomly assigned 738 patients ( in the ERASURE study ) and 1306 patients ( in the FIXTURE study ) to subcutaneous secukinumab at a dose of 300 mg or 150 mg ( administered once weekly for 5 weeks , then every 4 weeks ) , placebo , or ( in the FIXTURE study only ) etanercept at a dose of 50 mg ( administered twice weekly for 12 weeks , then once weekly ) .
-METHODS	The objective of each study was to show the superiority of secukinumab over placebo at week 12 with respect to the proportion of patients who had a reduction of 75 % or more from baseline in the psoriasis area-and-severity index score ( PASI 75 ) and a score of 0 ( clear ) or 1 ( almost clear ) on a 5-point modified investigator 's global assessment ( coprimary end points ) .
-RESULTS	The proportion of patients who met the criterion for PASI 75 at week 12 was higher with each secukinumab dose than with placebo or etanercept : in the ERASURE study , the rates were 81.6 % with 300 mg of secukinumab , 71.6 % with 150 mg of secukinumab , and 4.5 % with placebo ; in the FIXTURE study , the rates were 77.1 % with 300 mg of secukinumab , 67.0 % with 150 mg of secukinumab , 44.0 % with etanercept , and 4.9 % with placebo ( P < 0.001 for each secukinumab dose vs. comparators ) .
-RESULTS	The proportion of patients with a response of 0 or 1 on the modified investigator 's global assessment at week 12 was higher with each secukinumab dose than with placebo or etanercept : in the ERASURE study , the rates were 65.3 % with 300 mg of secukinumab , 51.2 % with 150 mg of secukinumab , and 2.4 % with placebo ; in the FIXTURE study , the rates were 62.5 % with 300 mg of secukinumab , 51.1 % with 150 mg of secukinumab , 27.2 % with etanercept , and 2.8 % with placebo ( P < 0.001 for each secukinumab dose vs. comparators ) .
-RESULTS	The rates of infection were higher with secukinumab than with placebo in both studies and were similar to those with etanercept .
-CONCLUSIONS	Secukinumab was effective for psoriasis in two randomized trials , validating interleukin-17A as a therapeutic target .
-CONCLUSIONS	( Funded by Novartis Pharmaceuticals ; ERASURE and FIXTURE ClinicalTrials.gov numbers , NCT01365455 and NCT01358578 , respectively . )
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-###25031133
-OBJECTIVE	To compare the short term efficacy and tolerability of methylphenidate and atomoxetine in children with Attention deficit hyperactivity disorder ( ADHD ) .
-METHODS	Open label randomized parallel group clinical trial .
-METHODS	Child Guidance Clinic of a tertiary care hospital of Northern India from October 2010 to June 2012 .
-METHODS	69 patients ( age 6-14 y ) with a diagnosis of ADHD receiving methylphenidate or atomoxetine .
-METHODS	Methylphenidate ( 0.2-1 mg/kg/d ) or atomoxetine ( 0.5-1 .2 mg/kg/d ) for eight weeks .
-METHODS	Treatment response ( > 25 % change in baseline Vanderbilt ADHD Diagnostic Parent Rating Scale ( VADPRS ) ; Vanderbilt ADHD Diagnostic Teacher Rating Scale ( VADTRS ) ; Clinical Global Impression Severity Scale ( CGI-S ) at eight weeks and adverse effects .
-RESULTS	Treatment response was observed in 90.7 % patients from methylphenidate group and 86.2 % patients of atomoxetine group at an average dose of 0.45 mg/kg/d and 0.61 mg/kg/d , respectively .
-RESULTS	The patients showed comparable improvement on VADPRS ( P = 0.500 ) , VADTRS ( P = 0.264 ) and CGI-S ( P = 0.997 ) .
-RESULTS	Weight loss was significantly higher in methylphenidate group ( -0.570.78 kg ; P = 0.001 ) , and heart rate increase was observed at higher rate in atomoxetine group ( 7 9 bpm ; P = 0.021 ) .
-CONCLUSIONS	Methylphenidate and atomoxetine are efficacious in Indian children with ADHD at lesser doses than previously used .
-CONCLUSIONS	Their efficacy and tolerability are comparable .
-CONCLUSIONS	TRIAL REGISTRATION NO. : CTRI/2011/08 / 001981 .
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-###24522306
-BACKGROUND	There is not known if a viraemia post-oral polio vaccine ( OPV ) is detectable by modern molecular techniques .
-BACKGROUND	Such viraemia could affect the performance of the real time-polymerase chain reaction ( PCR ) for non polio enterovirus ( EV ) detection , technique of growing clinical use for the study of febrile infants .
-OBJECTIVE	To determine viraemia post-first dose of OPV in healthy infants , by molecular techniques .
-METHODS	50 infants less than three months without previous VPO were randomized in 5 groups : a control group with pre-vaccination blood sample ( BS ) , group 1 BS at day 2 , group 2 BS at day 4 , group 3 , BS at day 6 and group 4 , BS at day 8 post-vaccination .
-METHODS	Conventional and specific PCR for poliovirus and real time PCR for non polio EV were performed in BS and in OPV samples .
-RESULTS	No genetic material of poliovirus was detected in any infant , while in 9 of them ( 18 % ) non polio EV was identified .
-RESULTS	Real time PCR for EV did not amplify poliovirus from OPV samples .
-CONCLUSIONS	Results suggest that no post VPO viraemia detectable by molecular methods exists .
-CONCLUSIONS	Considering that real time PCR for EV does not allow to identify polio virus , no false positives of the test are expected as a result of a recent VPO vaccination .
-CONCLUSIONS	We documented presence of non polio EV in blood of healthy asymptomatic infants .
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-###24330749
-BACKGROUND	An ageing population increases demand on health and social care .
-BACKGROUND	New approaches are needed to shift care from hospital to community and general practice .
-BACKGROUND	A predictive risk stratification tool ( Prism ) has been developed for general practice that estimates risk of an emergency hospital admission in the following year .
-BACKGROUND	We present a protocol for the evaluation of Prism .
-METHODS	We will undertake a mixed methods progressive cluster-randomised trial .
-METHODS	Practices begin as controls , delivering usual care without Prism .
-METHODS	Practices will receive Prism and training randomly , and thereafter be able to use Prism with clinical and technical support .
-METHODS	We will compare costs , processes of care , satisfaction and patient outcomes at baseline , 6 and 18 months , using routine data and postal questionnaires .
-METHODS	We will assess technical performance by comparing predicted against actual emergency admissions .
-METHODS	Focus groups and interviews will be undertaken to understand how Prism is perceived and adopted by practitioners and policy makers .
-METHODS	We will model data using generalised linear models and survival analysis techniques to determine whether any differences exist between intervention and control groups .
-METHODS	We will take account of covariates and explanatory factors .
-METHODS	In the economic evaluation we will carry out a cost-effectiveness analysis to examine incremental cost per emergency admission to hospital avoided and will examine costs versus changes in primary and secondary outcomes in a cost-consequence analysis .
-METHODS	We will also examine changes in quality of life of patients across the risk spectrum .
-METHODS	We will record and transcribe focus groups and interviews and analyse them thematically .
-METHODS	We have received full ethical and R and D approvals for the study and Information Governance Review Panel ( IGRP ) permission for the use of routine data .
-METHODS	We will comply with the CONSORT guidelines and will disseminate the findings at national and international conferences and in peer-reviewed journals .
-CONCLUSIONS	The proposed study will provide information on costs and effects of Prism ; how it is used in practice , barriers and facilitators to its implementation ; and its perceived value in supporting the management of patients with and at risk of developing chronic conditions .
-BACKGROUND	Controlled Clinical Trials ISRCTN no .
-BACKGROUND	ISRCTN55538212 .
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-###24739218
-BACKGROUND	The purpose of this study was to describe the longitudinal trajectories and bidirectional relationships of the physical-social and emotional functioning ( EF ) dimensions of positive aging and to identify their baseline characteristics .
-METHODS	Women age 65 and older who enrolled in one or more Women 's Health Initiative clinical trials ( WHI CTs ) and who had positive aging indicators measured at baseline and years 1 , 3 , 6 , and 9 were included in these analyses ( N = 2281 ) .
-METHODS	Analytic strategies included latent class growth modeling to identify longitudinal trajectories and multinomial logistic regression to examine the effects of baseline predictors on these trajectories .
-RESULTS	A five-trajectory model was chosen to best represent the data .
-RESULTS	For Physical-Social Functioning ( PSF ) , trajectory groups included Low Maintainer ( 8.3 % ) , Mid-Low Improver ( 10.4 % ) , Medium Decliner ( 10.7 % ) , Mid-High Maintainer ( 31.2 % ) , and High Maintainer ( 39.4 % ) ; for EF , trajectories included Low Maintainer ( 3 % ) , Mid-Low Improver ( 9 % ) , Medium Decliner ( 7.7 % ) , Mid-High Maintainer ( 22.8 % ) , and High Maintainer ( 57.5 % ) .
-RESULTS	Cross-classification of the groups of trajectories demonstrated that the impact of a high and stable EF on PSF might be greater than the reverse .
-RESULTS	Low depression symptoms , low pain , and high social support were the most consistent predictors of high EF trajectories .
-CONCLUSIONS	Aging women are heterogeneous in terms of positive aging indicators for up to 9 years of follow-up .
-CONCLUSIONS	Interventions aimed at promoting sustainable EF might have diffused effects on other domains of healthy aging .
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-###24517061
-OBJECTIVE	To observe the clinical efficacy of warming Shen , enhancing Yang , invigorating qi , and nourishing blood method ( WSEYIQNBM ) combined artificial cycle therapy in treatment of premature ovarian failure ( POF ) patients of Shen yang deficiency syndrome ( SYDS ) .
-METHODS	Totally 96 POF patients of SYDS were randomly assigned to the treatment group and the control group , 48 in each group .
-METHODS	Patients in the treatment group were treated with WSEYIQNBM combined artificial cycle therapy , while those in the control group were treated with Western medicine artificial cycle therapy .
-METHODS	One month constituted 1 course , a total of 3 courses .
-METHODS	The menstruation and main symptoms were observed before and after treatment .
-METHODS	Serum levels of follicle stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , and estradiol ( E2 ) were detected before and after treatment .
-RESULTS	The total effective rate was 85.43 % in the treatment group , higher than that of the control group ( 79.17 % , P < 0.05 ) .
-RESULTS	Besides , better effect in improving Chinese medical symptoms was obtained in the treatment group ( P < 0.05 ) .
-CONCLUSIONS	POF patients ' serum hormone levels and clinical symptoms could be improved by WSEYIQNBM combined artificial cycle therapy .
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-###25679344
-METHODS	Controlled laboratory study .
-OBJECTIVE	To determine the time course of dexamethasone sodium phosphate ( Dex-P ) during iontophoresis to underlying tissues using microdialysis .
-BACKGROUND	In human participants , real-time information of Dex-P transdermal delivery during iontophoresis is unknown .
-METHODS	Sixty-four healthy male participants ( mean SD age , 24.2 3.3 years ; height , 181.8 26.1 cm ; mass , 82.4 11.8 kg ; subcutaneous fat thickness , 0.61 0.19 cm ) were randomly assigned into 1 of 6 groups : ( 1 ) 1-mA current , 1-mm probe depth ; ( 2 ) 1-mA current , 4-mm probe depth ; ( 3 ) 2-mA current , 1-mm probe depth ; ( 4 ) 2-mA current , 4-mm probe depth ; ( 5 ) in vivo retrodialysis ; and ( 6 ) skin perfusion flowmetry .
-METHODS	Microdialysis probes were used to assess the combined recovery ( Dex-total ) of Dex-P , dexamethasone , and its metabolite .
-RESULTS	There was no difference in Dex-total between current intensities ( P = .99 ) , but a greater amount of Dex-total was recovered superficially at 1 mm compared to the 4-mm depth ( P < .0001 ) .
-RESULTS	Peak concentration mean SD values for the 1 - and 2-mA currents at 1 mm were 10.8 8.1 and 7.7 5.5 g/mL , and at 4 mm were 2.0 0.8 and 1.3 0.9 g/mL , respectively .
-RESULTS	Peak skin perfusion was 741.4 % 408.7 % and 711.6 % 260.8 % at baseline for 1 - and 2-mA intensities , respectively .
-RESULTS	Skin perfusion returned to baseline levels earlier during 1-mA intensity at a 110 mA min dose within the treatment , compared to 2 mA at 60 minutes posttreatment .
-CONCLUSIONS	Transdermal delivery of Dex-P during iontophoresis was successfully measured in vivo through human skin .
-CONCLUSIONS	Measurable concentrations of Dex-total were found regardless of current intensity .
-CONCLUSIONS	Although current-induced vasodilation occurred , it did not significantly affect the tissue accumulation of Dex-total .
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-###24351088
-BACKGROUND	Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress .
-BACKGROUND	This randomised controlled trial will investigate the effects of a transdiagnostic , Internet-administered cognitive behavioural ( iCBT ) self-help program for anxiety , supplemented with a smartphone application .
-BACKGROUND	The effect of added therapist support will also be studied .
-METHODS	One hundred and fifty participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to either one of three study groups : 1 , smartphone-supplemented iCBT with therapist support ; 2 , smartphone-supplemented iCBT without therapist support ; or 3 , an active waiting list control group with delayed treatment .
-METHODS	Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating scale .
-METHODS	Secondary measures include other anxiety , depression and quality of life measures .
-METHODS	In addition to pre - and post-treatment measurements , the study includes two mid-treatment ( days 24 and 48 ) and two follow-up assessments ( 12 and 36 months ) to assess rapid and long-term effects .
-CONCLUSIONS	To our knowledge , this is the first study to investigate the effectiveness of smartphone-supplemented iCBT for anxiety disorders .
-CONCLUSIONS	Hence , the findings from this trial will constitute great advancements in the burgeoning and promising field of smartphone-administered psychological interventions .
-CONCLUSIONS	Limitations are discussed .
-BACKGROUND	Clinicaltrials.gov : NCT01963806 .
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-###25504176
-BACKGROUND	Work with families and families at risk within the field of music therapy have been developing for the last decade .
-BACKGROUND	To diminish risk for unhealthy child development , families with emotionally neglected children need help to improve their emotional communication and develop healthy parent-child interactions .
-BACKGROUND	While some researchers have investigated the effect of music therapy on either the parent or the child , no study has investigated the effect of music therapy on the observed interaction between the parent and child within the field of child protection .
-OBJECTIVE	The purpose of this study was to investigate the effect of a dyadic music therapy intervention on observed parent-child interaction ( mutual attunement , nonverbal communication , emotional parental response ) , self-reported parenting stress , and self-reported parent-child relationship in families at risk and families with emotionally neglected children , ages 5-12 years .
-METHODS	This was a randomized controlled trial study conducted at a family care center in Denmark .
-METHODS	Eighteen parent-child dyads were randomly assigned to receive 10 weekly music therapy sessions with a credentialed music therapist ( n = 9 ) or treatment as usual ( n = 9 ) .
-METHODS	Observational measures for parent-child interaction , self-reported measures for parenting stress and parent-child relationship were completed at baseline and 4 months post-baseline assessment .
-RESULTS	Results of the study showed that dyads who received music therapy intervention significantly improved their nonverbal communication and mutual attunement .
-RESULTS	Similarly , parents who participated in dyadic music therapy reported themselves to be significantly less stressed by the mood of the child and to significantly improve their parent-child relationship in terms of being better at talking to and understanding their children than parents who did not receive music therapy .
-RESULTS	Both groups significantly improved in terms of increased positive and decreased negative emotional parental response , parenting stress and stress in general .
-RESULTS	There were no significant between group differences in self-perceived autonomy , attachment , and parental competence .
-CONCLUSIONS	The dyadic music therapy intervention examined in this study improved emotional communication between parent and child and interaction after 6 to 10 sessions and can be considered as a viable treatment alternative or supplement for families at risk and families with emotionally neglected children .
-
-###24938627
-OBJECTIVE	Symptoms and symptom burden have a central place in diagnosis and management of atrial fibrillation ( AF ) .
-OBJECTIVE	The aim of the present study is to investigate whether severity of AF symptoms impacts prognosis in permanent AF .
-RESULTS	We studied the relation between AF symptom severity [ quantified with the Toronto AF Severity Scale ( AFSS ) ] and cardiovascular outcome in patients included in the RACE II study .
-RESULTS	The primary endpoint was a composite of cardiovascular morbidity and mortality .
-RESULTS	Secondary outcome was cardiovascular hospitalizations .
-RESULTS	Of 614 permanent AF patients in RACE II , AFSS questionnaires were available in 558 patients ( 91 % ) .
-RESULTS	Mean age was 68 8 years .
-RESULTS	One hundred and seventy-four patients ( 31 % ) reported a low score ( score 0-3 ; lowest tertile ) , 190 patients ( 34 % ) reported a moderate score ( score 4-9 ; middle tertile ) , and 194 ( 35 % ) reported a high score ( score 10-35 ; highest tertile ) .
-RESULTS	Patients with the most severe symptoms were more often women , had higher N-terminal prohormone of brain natriuretic peptide concentrations , and had more previous heart failure hospitalizations .
-RESULTS	Median follow-up was 3.0 ( interquartile range 2.3-3 .0 ) years .
-RESULTS	The primary endpoint occurred most frequently in the highest tertile of the AFSS [ 16 ( 9 % ) , 19 ( 10 % ) , 36 ( 19 % ) , respectively , P = 0.01 ] , being mainly driven by heart failure hospitalizations [ 4 ( 2 % ) , 1 ( 1 % ) , 16 ( 8 % ) , respectively , P < 0.001 ] .
-RESULTS	After multivariable adjustment , higher AFSS scores were associated with the primary endpoint [ hazard ratio 1.38 ( 1.15-1 .66 ) , P = 0.001 ] , as well as with cardiovascular hospitalizations [ hazard ratio 1.33 ( 1.14-1 .54 ) , P < 0.001 ] .
-CONCLUSIONS	In permanent AF , after multivariable adjustment , symptom severity is associated with cardiovascular outcome .
-
-###25458157
-BACKGROUND	Combinations of inhaled long-acting bronchodilator therapies such as muscarinic antagonists and 2-agonists may be more effective than monotherapy in the treatment of chronic obstructive pulmonary disease ( COPD ) .
-METHODS	This study was a 24-week , Phase III , multicenter , randomized , blinded , double-dummy , parallel-group study of the once-daily , inhaled , fixed-dose combination of the long-acting muscarinic antagonist umeclidinium bromide and the long-acting 2-agonist vilanterol ( UMEC/VI 62.5 / 25 mcg ) versus tiotropium ( TIO , 18 mcg ) .
-METHODS	The primary endpoint was trough forced expiratory volume in 1 s ( FEV1 ) at Day 169 .
-METHODS	The secondary endpoint was weighted mean FEV1 over 06 h post-dose at Day 168 .
-METHODS	For key endpoints , a step-down closed testing hierarchy was applied to account for multiplicity .
-METHODS	Other efficacy and safety endpoints were assessed .
-RESULTS	Statistically significant improvements in trough FEV1 at Day 169 ( 0.112 L , 95 % confidence interval [ CI ] : 0.081 , 0.144 ; p < 0.001 ) and weighted mean FEV1 over 06 h post-dose at Day 168 ( 0.105 L , 95 % CI : 0.071 , 0.140 ; p < 0.001 ) were observed for UMEC/VI versus TIO .
-RESULTS	In addition UMEC/VI improved health-related quality of life , and reduced requirement for the use of rescue medication compared with TIO .
-RESULTS	The incidence of adverse events was similar between treatment groups .
-CONCLUSIONS	UMEC/VI was associated with statistically significant and clinically meaningful improvements in lung function versus TIO .
-CONCLUSIONS	UMEC/VI was well tolerated .
-CONCLUSIONS	UMEC/VI 62.5 / 25 mcg could provide an effective new treatment option for patients with moderate-to-very severe COPD .
-
-###25332473
-BACKGROUND	Previous human studies reported inconsistent effects of dietary protein and branched-chain amino acids ( BCAAs ) on insulin action and glucose metabolism .
-BACKGROUND	Similarly , it is unclear whether saturated fat ( SF ) intake influences these metabolic variables .
-OBJECTIVE	The objective of this study was to test the effects of high [ 30 % of energy ( % E ) ] vs. moderate ( 20 % E ) intakes of protein ( primarily whey ) on insulin action and lipid and lipoprotein concentrations in the context of both high ( 15 % E ) and low ( 7 % E ) SF diets .
-METHODS	The study was conducted as a randomized controlled trial in 158 overweight and obese men and women .
-METHODS	After a 4-wk baseline diet [ 55 % E carbohydrate , 15 % E protein , 30 % E fat ( 7 % E SF ) ] , participants were randomly assigned to 4 wk of either the baseline diet or 1 of 4 test diets containing 35 % E carbohydrate and either 20 % E or 30 % E protein and either 7 % E or 15 % E SF .
-METHODS	Frequently sampled i.v. glucose tolerance tests were administered after each dietary period .
-RESULTS	Other than significantly higher fasting glucose concentrations for high vs. moderate protein intakes with a low-fat diet ( difference SE : 0.47 0.14 mmol/L ; P = 0.001 ) , there were no significant effects of dietary protein or SF on glucose metabolism , plasma insulin , or concentrations of lipids and lipoproteins .
-RESULTS	Changes in plasma BCAAs across all diets were negatively correlated with changes in the metabolic clearance rate of insulin ( = -0.18 , P = 0.03 ) and positively correlated with changes in the acute insulin response to glucose ( = 0.15 , P = 0.05 ) .
-CONCLUSIONS	These findings suggest that short-term intake of BCAAs can influence insulin dynamics .
-CONCLUSIONS	However , in this group of overweight and obese individuals , neither high protein nor SF intake affected insulin sensitivity or plasma concentrations of lipids and lipoproteins .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00508937 .
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-###24385182
-BACKGROUND	Combination long-acting bronchodilator therapy may be more effective than long-acting bronchodilator monotherapy in chronic obstructive pulmonary disease ( COPD ) .
-OBJECTIVE	To compare the efficacy and safety of once-daily umeclidinium/vilanterol ( UMEC/VI ) 125/25 mcg with placebo and UMEC or VI monotherapy in COPD .
-METHODS	This was a double-blind , placebo-controlled , parallel-group study .
-METHODS	A total of 1493 patients were randomized ( 3:3:3:2 ) to 24 weeks of treatment with UMEC/VI 125/25 mcg , UMEC 125 mcg , VI 25 mcg , or placebo once-daily via dry powder inhaler .
-RESULTS	Primary efficacy endpoint was trough forced expiratory volume in one second ( FEV1 ) on Day 169 ( 23-24 h post-dose ) .
-RESULTS	Additional lung-function , symptomatic and health-related quality of life endpoints were also assessed .
-RESULTS	Safety evaluations included : adverse events , vital signs , electrocardiography and clinical laboratory measurements .
-RESULTS	All active treatments significantly improved trough FEV1 vs placebo ( 0.124-0 .238 L , all p < 0.001 ) .
-RESULTS	Improvements with UMEC/VI 125/25 mcg were significantly greater than for UMEC 125 mcg or VI 25 mcg ( 0.079 L and 0.114 L ; both p0 .001 ) .
-RESULTS	Improvements for UMEC/VI 125/25 mcg vs placebo were observed for the transition dyspnea index ( 1.0 unit ; p < 0.001 ) , rescue albuterol use at Weeks 1-24 ( -1.5 puffs/day ) and St. George 's Respiratory Questionnaire ( -3.60 units , p < 0.001 ) .
-RESULTS	No safety signals were observed .
-CONCLUSIONS	Once-daily UMEC/VI 125/25 mcg was well tolerated and provided greater improvements in lung function , health status , and dyspnea scores compared with monotherapy components and placebo over 24 weeks .
-CONCLUSIONS	This study supports the use of UMEC/VI 125/25 mcg for the maintenance treatment of COPD .
-BACKGROUND	protocol number : DB2113361 ; ClinicalTrials.gov identifier : NCT01313637 .
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-###25129615
-BACKGROUND	The set-back suture , an absorbable dermal suturing technique , purportedly improves wound eversion and cosmetic outcomes .
-OBJECTIVE	We sought to conduct a split-wound , prospective , randomized study to compare the cosmetic outcome and wound eversion achieved with the set-back suture and the buried vertical mattress suture ( BVMS ) .
-METHODS	A total of 46 surgical elliptical wounds were randomized to subcuticular closure with the set-back suture on half and the BVMS on the other .
-METHODS	Maximum eversion height and width were measured immediately postoperatively .
-METHODS	At 3 months , 2 blinded observers evaluated each scar using a 7-point Likert physician global scar assessment scale .
-METHODS	Subjects and observers also completed the validated Patient and Observer Scar Assessment Scale , where a score of 6 represents normal-appearing skin and 60 represents worst imaginable scar .
-RESULTS	In all , 42 subjects completed the study .
-RESULTS	The set-back suture provided statistically significant wound eversion .
-RESULTS	On the Likert scale , observers rated the set-back suture side 1 point better than the BVMSside .
-RESULTS	Both patient and observer total Patient and Observer Scar Assessment Scale scores were significantly lower for the set-back suture side ( subject mean 13.0 8.7 vs 16.2 12.0 [ P = .039 ] ; observer mean 24.5 10.4 vs 27.7 13.6 [ P = .028 ] , respectively ) .
-CONCLUSIONS	Single institution experience and relatively short follow-up are limitations .
-CONCLUSIONS	The set-back suture provides superior wound eversion and better cosmetic outcomes than the BVMS .
-
-###24906252
-OBJECTIVE	Macitentan is a novel dual endothelin ( ET ) -1 receptor antagonist to be used in patients with pulmonary arterial hypertension .
-OBJECTIVE	This study aimed to assess the pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of macitentan after administration of multiple doses to healthy Korean male subjects .
-METHODS	A randomized , double-blind , placebo-controlled , multiple-ascending dose study was performed in 30 healthy male subjects receiving oral macitentan ( 3 , 10 , or 30 mg ) or placebo once daily for 10 days .
-METHODS	Plasma concentrations of macitentan , its active metabolite ACT-13277 , and ET-1 were evaluated .
-METHODS	Safety and tolerability measurements were conducted throughout the study .
-RESULTS	The concentration-time profile of macitentan was characterized by slow absorption ( median time to maximum plasma concentration [ t ( max ) ] 9-10 h ) and slow elimination ( mean elimination half-life [ t ] 11-15 h ) .
-RESULTS	After repeated doses of 3 , 10 , and 30 mg of macitentan over the course of 10 days , the peak concentration ( C ( max ) ) increased as the dose increased and the area under the plasma concentration-time curve during the dosing interval ( AUC ( ) ) increased in a dose-proportional manner .
-RESULTS	Plasma concentrations showed approximately 1.5 - to 1.9-fold accumulation on day 10 compared with day 1 .
-RESULTS	ACT-132577 showed higher levels of exposure than macitentan , its mean half-life was 46-48 h , and it accumulated 7 - to 12-fold .
-RESULTS	Macitentan increased plasma ET-1 concentrations at all doses tested and was well tolerated and elicited no serious adverse events .
-CONCLUSIONS	Multiple oral doses of 3 , 10 , and 30 mg of macitentan were well tolerated in healthy Korean subjects , and its pharmacokinetics correlated positively with ET-1 concentrations .
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-###24508036
-BACKGROUND	This study investigated the safety and immunogenicity of different formulations and schedules of a candidate subunit herpes zoster vaccine containing varicella-zoster virus glycoprotein E ( gE ) with or without the adjuvant system AS01B .
-METHODS	In this phase II , single-blind , randomized , controlled study , adults aged 60years ( N = 714 ) received one dose of 100ggE/AS01B , two doses , two months apart , of 25 , 50 , or 100ggE/AS01B , or two doses of unadjuvanted 100ggE/saline .
-METHODS	Frequencies of CD4 ( + ) T cells expressing 2 activation markers following induction with gE were measured by intracellular cytokine staining and serum anti-gE antibody concentrations by ELISA .
-RESULTS	Frequencies of gE-specific CD4 ( + ) T cells were > 3-fold higher after two doses of all gE/AS01B formulations than after one dose of 100ggE/AS01B or two doses of 100ggE/saline .
-RESULTS	Frequencies were comparable after two doses of 25 , 50 , or 100ggE/AS01B .
-RESULTS	Serum anti-gE antibody concentrations were comparable after two doses of 50 or 100ggE/AS01B and higher than in the other groups .
-RESULTS	Immune responses persisted for at least 36 months .
-RESULTS	Reactogenicities of all gE/AS01B formulations were similar but greater than with gE/saline .
-CONCLUSIONS	The three formulations of gE/AS01B were immunogenic and well tolerated in adults aged 60years .
-CONCLUSIONS	Two vaccinations with gE/AS01B induced higher immune responses than one and the dose of gE impacted humoral but not cellular immune responses ( NCT00434577 ) .
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-###25293975
-BACKGROUND	In Denmark , guidelines on low back pain management are currently being implemented ; in association with this , a clinical trial is conducted .
-BACKGROUND	A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners ' adherence to the guidelines .
-BACKGROUND	In addition to usual dissemination , the extended implementation strategy is composed of visits from a guideline facilitator , stratification tools , and feedback on guideline adherence .
-BACKGROUND	The aim of this paper is to provide the considerations on the design of the health economic evaluation .
-METHODS	The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region .
-METHODS	An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled .
-METHODS	The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis .
-METHODS	Effectiveness measures include referral to secondary care , health-related quality of life measured by EQ-5D-5L , and disability measured by the Roland Morris disability questionnaire .
-METHODS	Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation .
-METHODS	The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon .
-CONCLUSIONS	It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care .
-CONCLUSIONS	It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes , thereby rendering the extended implementation strategy cost-effective .
-BACKGROUND	ClinicalTrials.gov : NCT01699256 .
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-###24562799
-BACKGROUND	Many pathogenic processes and diseases are the result of an erroneous activation of the complement cascade and a number of inhibitors of complement have thus been examined for anti-inflammatory actions .
-BACKGROUND	It was recently demonstrated that supraphysiological concentrations of the endogenous complement inhibitor MAp44 ( also denoted MAP1 ) protect against myocardial reperfusion injury .
-BACKGROUND	In the present study , we examined the association between outcome after acute myocardial infarction ( MI ) and the plasma levels of MAp44 and its related proteins MASP-1 and MASP-3 in patients with first-time MI .
-BACKGROUND	In addition , we compared plasma levels of MAp44 , MASP-1 , and MASP-3 in MI patients to levels in a healthy control group .
-METHODS	A total of 192 MI patients and 140 control persons were included .
-METHODS	Plasma samples were obtained and analysed with time-resolved immunofluorometric assays determining the plasma levels of MAp44 , MASP-1 , and MASP-3 .
-METHODS	The myocardial outcomes ( salvage index and final infarct size ) were measured by gated single-photon emission CT. .
-RESULTS	MI patients had 18 % higher plasma levels of MAp44 ( IQR 11-25 % ) as compared to the healthy control group ( p < 0.001 .
-RESULTS	However , neither salvage index ( Spearman rho -0.1 , p = 0.28 ) nor final infarct size ( Spearman rho 0.02 , p = 0.83 ) correlated with plasma levels of MAp44 .
-RESULTS	Likewise , MASP-1 and MASP-3 were elevated in MI patients ( p = 0.002 and p < 0.001 ) , but the levels were not correlated to outcome .
-CONCLUSIONS	Plasma levels of MAp44 , MASP-1 , and MASP-3 are significantly higher in patients with MI compared to healthy control persons , but are not associated with short-term outcome measured as salvage index and final infarct .
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-###25702876
-BACKGROUND	The optimum duration of androgen deprivation combined with high-dose radiotherapy in prostate cancer remains undefined .
-BACKGROUND	We aimed to determine whether long-term androgen deprivation was superior to short-term androgen deprivation when combined with high-dose radiotherapy .
-METHODS	In this open-label , multicentre , phase 3 randomised controlled trial , patients were recruited from ten university hospitals throughout Spain .
-METHODS	Eligible patients had clinical stage T1c-T3b N0M0 prostate adenocarcinoma with intermediate-risk and high-risk factors according to 2005 National Comprehensive Cancer Network criteria .
-METHODS	Patients were randomly assigned ( 1:1 ) using a computer-generated randomisation schedule to receive either 4 months of androgen deprivation combined with three-dimensional conformal radiotherapy at a minimum dose of 76 Gy ( range 76-82 Gy ; short-term androgen deprivation group ) or the same treatment followed by 24 months of adjuvant androgen deprivation ( long-term androgen deprivation group ) , stratified by prostate cancer risk group ( intermediate risk vs high risk ) and participating centre .
-METHODS	Patients assigned to the short-term androgen deprivation group received 4 months of neoadjuvant and concomitant androgen deprivation with subcutaneous goserelin ( 2 months before and 2 months combined with high-dose radiotherapy ) .
-METHODS	Anti-androgen therapy ( flutamide 750 mg per day or bicalutamide 50 mg per day ) was added during the first 2 months of treatment .
-METHODS	Patients assigned to long-term suppression continued with the same luteinising hormone-releasing hormone analogue every 3 months for another 24 months .
-METHODS	The primary endpoint was biochemical disease-free survival .
-METHODS	Analysis was by intention to treat .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT02175212 .
-RESULTS	Between Nov 7 , 2005 , and Dec 20 , 2010 , 178 patients were randomly assigned to receive short-term androgen deprivation and 177 to receive long-term androgen deprivation .
-RESULTS	After a median follow-up of 63 months ( IQR 50-82 ) , 5-year biochemical disease-free survival was significantly better among patients receiving long-term androgen deprivation than among those receiving short-term treatment ( 90 % [ 95 % CI 87-92 ] vs 81 % [ 78-85 ] ; hazard ratio [ HR ] 188 [ 95 % CI 112-315 ] ; p = 001 ) .
-RESULTS	5-year overall survival ( 95 % [ 95 % CI 93-97 ] vs 86 % [ 83-89 ] ; HR 248 [ 95 % CI 131-468 ] ; p = 0009 ) and 5-year metastasis-free survival ( 94 % [ 95 % CI 92-96 ] vs 83 % [ 80-86 ] ; HR 231 [ 95 % CI 123-385 ] ; p = 001 ) were also significantly better in the long-term androgen deprivation group than in the short-term androgen deprivation group .
-RESULTS	The effect of long-term androgen deprivation on biochemical disease-free survival , metastasis-free survival , and overall survival was more evident in patients with high-risk disease than in those with low-risk disease .
-RESULTS	Grade 3 late rectal toxicity was noted in three ( 2 % ) of 177 patients in the long-term androgen deprivation group and two ( 1 % ) of 178 in the short-term androgen deprivation group ; grade 3-4 late urinary toxicity was noted in five ( 3 % ) patients in each group .
-RESULTS	No deaths related to treatment were reported .
-CONCLUSIONS	Compared with short-term androgen deprivation , 2 years of adjuvant androgen deprivation combined with high-dose radiotherapy improved biochemical control and overall survival in patients with prostate cancer , particularly those with high-risk disease , with no increase in late radiation toxicity .
-CONCLUSIONS	Longer follow-up is needed to determine whether men with intermediate-risk disease benefit from more than 4 months of androgen deprivation .
-BACKGROUND	Spanish National Health Investigation Fund , AstraZeneca .
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-###24387886
-OBJECTIVE	The main objective of this pilot study was to explore the effect of chiropractic high-velocity , low-amplitude ( HVLA ) manipulation on vertical jump height in young female athletes with talocrural joint dysfunction .
-METHODS	This was a randomized assessor-blind clinical pilot trial .
-METHODS	Twenty-two female handball players with talocrural joint dysfunction were randomized to receive either HVLA manipulation ( n = 11 ) or sham treatment ( n = 11 ) once a week during a 3-week period .
-METHODS	The main outcome was change in vertical jump height from baseline to follow-up within and between groups after 3 weeks .
-RESULTS	Nineteen athletes completed the study .
-RESULTS	After 3 weeks , the group receiving HVLA manipulation ( n = 11 ) had a statistically significant mean ( SD ) improvement in vertical jump height of 1.07 ( 1.23 ) cm ( P = .017 ) .
-RESULTS	The sham treatment group ( n = 8 ) improved their vertical jump height by 0.59 ( 2.03 ) cm ( P = .436 ) .
-RESULTS	The between groups ' change was 0.47 cm ( 95 % confidence interval , -1.31 to 2.26 ; P = .571 ) in favor of the group receiving HVLA manipulation .
-RESULTS	Blinding and sham procedures were feasible , and there were no reported adverse events .
-CONCLUSIONS	The results of this pilot study show that a larger-scale study is feasible .
-CONCLUSIONS	Preliminary results suggest that chiropractic HVLA manipulation may increase vertical jump height in young female athletes with talocrural joint dysfunction .
-CONCLUSIONS	However , the clinical result in favor of HVLA manipulation compared with sham treatment needs statistical confirmation in a larger randomized clinical trial .
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-###25204510
-OBJECTIVE	To investigate whether a novel ultrasound device may be used with a simplified augmented reality technique , and to compare this device with conventional techniques during vascular access using a vascular phantom .
-METHODS	Prospective , randomized study .
-METHODS	Anesthesiology and Pain Medicine departments of a university-affiliated hospital .
-METHODS	20 physicians with no experience with ultrasound-guided techniques .
-METHODS	All participants performed the vascular access technique on the vascular phantom model using both a conventional device and the new ultrasound device .
-METHODS	Time and the number of redirections of the needle until aspiration of dye into a vessel of the vascular phantom were measured .
-RESULTS	The median/interquartile range of time was 39.5 / 41.7 seconds versus 18.6 / 10.0 seconds ( P < 0.001 ) and number of redirections was 3/3 .5 versus 1/0 ( P < 0.001 ) for the conventional and novel ultrasound devices , respectively .
-CONCLUSIONS	During vascular access in a vascular phantom model , the novel device decreased the time and the number of redirections significantly .
-CONCLUSIONS	The device successfully improved the efficiency of the ultrasound-guided vascular access technique .
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-###24714360
-BACKGROUND	The mechanisms behind heterologous immunity and non-specific effects of vaccines on mortality are not well understood .
-BACKGROUND	We examined associations between cytokine responses and subsequent mortality in low-birth-weight infants in Guinea-Bissau .
-METHODS	A low-birth-weight trial randomized children to Bacille Calmette-Gurin ( BCG ) at birth or later according to local policy .
-METHODS	Blood samples were obtained from a sub-group at age 6 weeks .
-METHODS	Interleukin ( IL ) -5 , IL-10 , IL-13 , interferon ( IFN ) - , and tumor necrosis factor ( TNF ) - were measured in whole-blood cell cultures stimulated with lipopolysaccharide ( LPS ) , phytohaemagglutinin ( PHA ) , or purified protein derivative ( PPD ) .
-METHODS	The outcome was mortality between bleeding and 1 year of age .
-METHODS	Non-linear associations between cytokine responses and mortality were examined .
-RESULTS	Cytokine measurements were available from 390 children .
-RESULTS	The mortality rate ( MR ) was high ( 6.8 / 100 person-years-observation ( PYO ) ) .
-RESULTS	Both low and high cytokine responses to LPS and PHA were associated with high mortality ( MR up to 25/100 PYO in the lowest 10 % and 9.2 / 100 PYO in the highest 10 % ) .
-RESULTS	In BCG-vaccinated children , higher IFN - responses to PPD were associated with better survival ( MR ratio = 0.43 ( 0.24-0 .77 ) ) .
-CONCLUSIONS	Data presented a rare opportunity to explore associations between cytokine responses and mortality .
-CONCLUSIONS	Both low and high cytokine responses were associated with high mortality ; a balanced response to invading pathogens seems preferable .
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-###24901386
-BACKGROUND	Hospitalization is an important outcome in pulmonary arterial hypertension ( PAH ) , shown previously to correlate with survival .
-BACKGROUND	Using the Registry to Evaluate Early and Long-term PAH Disease Management ( REVEAL Registry ) , we sought to characterize first-time hospitalizations and their effect on subsequent hospitalization and survival in patients with newly diagnosed disease .
-METHODS	Patients with newly diagnosed PAH ( n = 862 , World Health Organization group 1 ) were evaluated for first-time hospitalization .
-METHODS	The hospitalizations were categorized as PAH related or PAH unrelated based on the case report form .
-METHODS	Categories for PAH-related and PAH-unrelated hospitalization were defined before independent review .
-METHODS	Patient demographics and disease characteristics are described as well as freedom from hospitalization and survival .
-RESULTS	Of 862 patients , 490 ( 56.8 % ) had one or more hospitalizations postenrollment : 257 ( 52.4 % ) PAH related , 214 ( 43.7 % ) PAH unrelated , and 19 ( 3.9 % ) of undetermined causes .
-RESULTS	The most common causes of PAH-related hospitalization were congestive heart failure and placement/removal of a central venous catheter .
-RESULTS	Patients with PAH-related hospitalizations were more likely to receive parenteral therapy , be in functional class III/IV , and have higher risk scores before hospitalization at enrollment .
-RESULTS	Following discharge , 25.4 % 3.2 % and 31.0 % 4.0 % of patients with PAH-related and PAH-unrelated first hospitalization , respectively , remained hospitalization-free for 3 years ( P = .11 ) .
-RESULTS	Survival estimates at 3 years postdischarge were 56.8 % 3.5 % and 67.8 % 3.6 % ( P = .037 ) for patients with PAH-related and PAH-unrelated hospitalization , respectively .
-CONCLUSIONS	In the REVEAL Registry , PAH-related hospitalization was associated with relatively more rehospitalizations and worse survival at 3 years .
-BACKGROUND	ClinicalTrials.gov ; No. : NCT00370214 ; URL : www.clinicaltrials.gov .
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-###24268907
-OBJECTIVE	Patients treated with oral anticoagulants have increased susceptibility to bleeding , and therefore any surgical medical procedure and especially oral surgery requires a therapeutic approach that minimizes bleeding effects in these patients .
-METHODS	The working hypothesis was based on studies of local application of tranexamic acid after maxillofacial interventions as effective therapeutic alternative for the prevention and control of bleeding .
-METHODS	The aim was to assess the effectiveness of the application of a gel solution tranexamic acid after tooth extraction in anticoagulated patients in terms of healing time and degree of healing .
-RESULTS	The results indicate that application of tranexamic acid gel is very effective for consistency and maintenance in the place of action and shows its efficacy as a procoagulant material .
-CONCLUSIONS	The application of a gel solution of tranexamic acid in oral anticoagulants patients ameliorates healing time and the bleeding time within the first 48-72 h.
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-###24942954
-OBJECTIVE	The impact of food on relapse in ulcerative colitis has not been clearly defined .
-OBJECTIVE	The aim of this prospective , randomized-controlled study was to evaluate the impact of comprehensive dietary guidelines on the clinical course of the disease and quality of life in patients with ulcerative colitis .
-METHODS	Patients were allocated randomly to an intervention or a control group .
-METHODS	Participants in the intervention group were provided dietary guidelines in the form of an educational booklet that was recommended for use for 4-6 weeks during disease flare , that patients eat little and often ( four to six times a day ) , drink adequate fluids , decrease excess intake of fat , decrease simple carbohydrates and decrease high-fibre foods during flare.Validated and study-designed questionnaires were used to compare patients ' perceived quality of life , colitis activity scores and eating habits before and following the dietary advice provided .
-RESULTS	Overall , 112 patients completed the study .
-RESULTS	Study participants were asked to complete the Inflammatory Bowel Disease Questionnaire and Simple Clinical Colitis Activity Index together with the Food Frequency Questionnaire at 0 , 6 and 24 weeks .
-RESULTS	At 24 weeks , there was a mean reduction in the Simple Clinical Colitis Activity Index score in the intervention group compared with an increase in the score in the control group [ -1.304 ( P = 0.0108 ) vs. 0.875 ( P = 0.0249 ) ] .
-RESULTS	There was a mean increase in the Inflammatory Bowel Disease Questionnaire score in the intervention group compared with a reduction in the score in the control group [ 7.17 ( P = 0.126 ) vs. -3.44 ( P = 0.205 ) ] .
-RESULTS	A total of 69 % of patients in the intervention group found the dietary advice significantly or moderately helpful .
-CONCLUSIONS	The study suggests that there is likely to be a link between the dietary advice provided and symptomatic improvement .
-CONCLUSIONS	The effect of diet may not occur through the addition or the elimination of single nutrients ; rather , each food consumed combines many nutrients that allow for a synergistic or an antagonistic action when present in a certain composition .
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-###25171074
-BACKGROUND	Intravitreal injection ( IVT ) is one of the most common vitreoretinal procedures , a large majority are performed with local anesthesia .
-BACKGROUND	The purpose of this study was to investigate the safety to the cornea and anesthetic efficacy of five concentrations of lidocaine gel .
-METHODS	A prospective clinical trial was conducted testing lidocaine gel in five preparations : 2 , 3.5 , 5 , 8 and 12 % .
-METHODS	Patients with macular degeneration , diabetic edema or retina vein occlusion were scheduled for intravitreal treatment received topical anesthesia with lidocaine gel 5 and 10 min before the procedure .
-METHODS	Patients answered the visual analog scale for pain during the procedure .
-METHODS	Corneal and conjunctival was evaluated using the Oxford scale .
-RESULTS	In total , 260 patients were randomized into five groups .
-RESULTS	The mean pain scores ( standard deviation ) were 2.63 ( 1.68 ) in the 2 % group , 2.08 ( 1.35 ) in the 3.5 % ; 2.00 ( 1.65 ) in the 5 % , 1.93 ( 1.40 ) in the 8 % and 1.83 ( 1.35 ) in the 12 % group .
-RESULTS	Mean pain score among all groups was similar ( p = 0.077 ) .
-RESULTS	There was no significant difference between groups in regard to keratitis mean score ( p = 0.897 ) .
-CONCLUSIONS	Lidocaine gel at concentrations from 2 to 12 % induced similar anesthetic effect for IVTs , without adverse effects on cornea and conjunctiva .
-
-###25892016
-OBJECTIVE	To evaluate the efficacy and safety of intravitreal bevacizumab ( Avastin ; Genentech , South San Francisco , CA ) in patients with neovascular age-related macular degeneration ( nAMD ) using 2 different treatment regimens in which patients were assessed clinically at up to 12-week intervals .
-METHODS	Randomized , controlled , noninferiority trial .
-METHODS	A total of 331 patients with nAMD .
-METHODS	Patients were treated with 1.25 mg intravitreal bevacizumab and followed up to 92 weeks .
-METHODS	They were randomized into 2 arms .
-METHODS	All patients received 3 loading doses 4 weeks apart and thereafter were assessed every 12 weeks until the end of the study .
-METHODS	One arm received a routine treatment at each 12-week assessment , and the other arm was treated at these assessments on an as-needed basis .
-METHODS	After the loading doses , patients in either arm who showed signs of disease activity had an additional assessment after 6 weeks and at that visit had top-up treatments on an as-needed basis .
-METHODS	Mean best-corrected visual acuity ( BCVA ) at 92 weeks .
-RESULTS	At 92 weeks , patients who had treatments every 12 weeks had superior BCVA to those treated on an as-needed basis every 12 weeks ( P = 0.008 ) , with the regular treatment arm gaining a mean BCVA of 5.5 letters and the as-needed treatment arm gaining 0.6 letters .
-RESULTS	The regular treatment arm of the study showed significantly improved outcomes with respect to 5 - , 10 - , and 15-letter changes in BCVA from baseline compared with the as-needed treatment arm , as well as superior reading speed .
-RESULTS	In patients who completed the study , up to but not including week 92 , the mean number of treatments was 10.8 for the regular treatment arm and 9.1 for the as-needed treatment arm .
-CONCLUSIONS	A treatment regimen with regular bevacizumab injections every 12 weeks after loading doses supplemented with as-needed top-up treatments produced a stable improvement in BCVA from baseline .
-CONCLUSIONS	The improvement in BCVA was broadly similar to that obtained in other studies using anti-vascular endothelial growth factor drugs with more frequent assessments and treatments .
-
-###26169008
-OBJECTIVE	To report our prospective comparison of clinical efficacy between multimodular flexible ureteroscope , PolyScope , and conventional flexible ureteroscope , both combined with holmium laser lithotripsy in managing renal stones < 3cm in diameter .
-METHODS	Between February 2011 and July 2014 , a total of 360 adult patients with renal stones were randomized in a single tertiary-care center trial .
-METHODS	For 180 patients in each arm , flexible ureteroscopy and holmium laser lithotripsy were done with either PolyScope or Olympus URF P-5 as control .
-METHODS	The primary end points were single-session stone fragmentation rate and stone-free rate .
-METHODS	The secondary end points comprised operation time , complication rate , and hospital stay .
-RESULTS	Demographic and preoperative parameters were comparable between 2 groups .
-RESULTS	For stones of different locations and sizes , single-session stone fragmentation rate of PolyScope was similar to that of URF P-5 .
-RESULTS	However , for lower calyceal stones , URF P-5 was significantly better than PolyScope ( 82.0 % vs 69.2 % ; P = .022 ) .
-RESULTS	No statistically significant difference existed in single-session or overall stone-free rate , complication rate , and hospital stay .
-RESULTS	Mean operation time of PolyScope group was 92.620.2 minutes , 9minutes ( 10.8 % ) longer than that of URF P-5 group 83.317.1 minutes ( P < .01 ) .
-CONCLUSIONS	PolyScope demonstrates similar overall stone clearance rate to a conventional flexible ureteroscope in managing renal calculi < 3cm in diameter , but for lower pole stones , it is of inferior efficacy and it is more skillfully demanding , taking longer operation time .
-
-###25284739
-OBJECTIVE	The purposes of this study were to use functional magnetic resonance imaging to investigate the immediate changes in functional connectivity ( FC ) between brain regions that process and modulate the pain experience after 3 different types of manual therapies ( MT ) and to identify reductions in experimentally induced myalgia and changes in local and remote pressure pain sensitivity .
-METHODS	Twenty-four participants ( 17 men ; mean age SD , 21.6 4.2 years ) who completed an exercise-injury protocol to induce low back pain were randomized into 3 groups : chiropractic spinal manipulation ( n = 6 ) , spinal mobilization ( n = 8 ) , or therapeutic touch ( n = 10 ) .
-METHODS	The primary outcome was the immediate change in FC as measured on functional magnetic resonance imaging between the following brain regions : somatosensory cortex , secondary somatosensory cortex , thalamus , anterior and posterior cingulate cortices , anterior and poster insula , and periaqueductal gray .
-METHODS	Secondary outcomes were immediate changes in pain intensity , measured with a 101-point numeric rating scale , and pain sensitivity , measured with a handheld dynamometer .
-METHODS	Repeated-measures analysis of variance models and correlation analyses were conducted to examine treatment effects and the relationship between within-person changes across outcome measures .
-RESULTS	Changes in FC were found between several brain regions that were common to all 3 MT interventions .
-RESULTS	Treatment-dependent changes in FC were also observed between several brain regions .
-RESULTS	Improvement was seen in pain intensity after all interventions ( P < .05 ) with no difference between groups ( P > .05 ) .
-RESULTS	There were no observed changes in pain sensitivity , or an association between primary and secondary outcome measures .
-CONCLUSIONS	These results suggest that MTs ( chiropractic spinal manipulation , spinal mobilization , and therapeutic touch ) have an immediate effect on the FC between brain regions involved in processing and modulating the pain experience .
-CONCLUSIONS	This suggests that neurophysiologic changes after MT may be an underlying mechanism of pain relief .
-
-###24769306
-OBJECTIVE	This study tested the hypothesis that pioglitazone reduces endothelin-1 activity in the forearm vasculature in non-diabetic patients with hypertension or hypercholesterolemia and variable degrees of insulin resistance .
-METHODS	We conducted a single center , randomized , double-blind , placebo controlled , cross-over trial in 80 patients with either hypertension or hypercholesterolemia and further classified as insulin-sensitive or insulin-resistant based on a published insulin sensitivity index .
-METHODS	Participants received pioglitazone 45 mg daily or matching placebo for eight weeks .
-METHODS	The main endpoint was the change in forearm vascular endothelin-1 activity , as assessed by intra-arterial infusion of the endothelin type A receptor blocker BQ-123 , measured at the end of each 8-week treatment period .
-RESULTS	Pioglitazone lowered plasma insulin ( P < 0.001 ) , improved insulin sensitivity ( P < 0.001 ) , increased HDL ( P < 0.001 ) , and reduced triglycerides ( P = 0.003 ) , free fatty acids ( P = 0.005 ) , and C-reactive protein ( P = 0.001 ) .
-RESULTS	However , pioglitazone did not affect the vasodilator response to BQ-123 in the whole group ( P = 0.618 ) and in the diagnosis or insulin sensitivity subgroups .
-RESULTS	Hence , in non-diabetic patients with hypertension or hypercholesterolemia , PPAR activation with pioglitazone does not affect endothelin-1 activity , despite enhancing insulin sensitivity and reducing plasma insulin and C-reactive protein levels .
-CONCLUSIONS	In non-diabetic patients with hypertension or hypercholesterolemia , pioglitazone improves insulin sensitivity , lipid profile , and inflammation but does not affect endothelin activity .
-CONCLUSIONS	Our data suggest that the determinants of endothelin-1 vascular activity in vivo may differ and/or be more complex than those suggested by the results of previous in vitro studies .
-
-###25668008
-BACKGROUND	There is a need for interventions to promote uptake of breast screening throughout Europe .
-METHODS	We performed a single-blind randomised controlled trial to test whether text-message reminders were effective .
-METHODS	Two thousand two hundred and forty women receiving their first breast screening invitation were included in the study and randomly assigned in a 1:1 ratio to receive either a normal invitation only ( n = 1118 ) or a normal invitation plus a text-message reminder 48h before their appointment ( n = 1122 ) .
-RESULTS	In the intention-to-treat analysis , uptake of breast screening was 59.1 % among women in the normal invitation group and 64.4 % in the text-message reminder group ( ( 2 ) = 6.47 , odds ratio ( OR ) : 1.26 , 95 % confidence intervals ( CI ) : 1.05-1 .48 , P = 0.01 ) .
-RESULTS	Of the 1122 women assigned to the text-message reminder group , only 456 ( 41 % ) had a mobile number recorded by their GP and were thereby sent a text .
-RESULTS	In the per-protocol analysis , uptake by those in the control group who had a mobile number recorded on the GP system was 59.77 % and by those in the intervention group who were sent a reminder 71.7 % ( ( 2 ) = 14.12 , OR = 1.71 , 95 % CI = 1.29-2 .26 , P < 0.01 ) .
-CONCLUSIONS	Sending women a text-message reminder before their first routine breast screening appointment significantly increased attendance .
-CONCLUSIONS	This information can be used to allocate resources efficiently to improve uptake without exacerbating social inequalities .
-
-###25490525
-BACKGROUND	Although exercise has been addressed as an adjuvant treatment for anxiety , depression and cancer-related symptoms , limited studies have evaluated the effectiveness of exercise in patients with lung cancer .
-METHODS	We recruited 116 patients from a medical centre in northern Taiwan , and randomly assigned them to either a walking-exercise group ( n = 58 ) or a usual-care group ( n = 58 ) .
-METHODS	We conducted a 12-week exercise programme that comprised home-based , moderate-intensity walking for 40min per day , 3 days per week , and weekly exercise counselling .
-METHODS	The outcome measures included the Hospital Anxiety and Depression Scale and the Taiwanese version of the MD Anderson Symptom Inventory .
-RESULTS	We analysed the effects of the exercise programme on anxiety , depression and cancer-related symptoms by using a generalised estimating equation method .
-RESULTS	The exercise group patients exhibited significant improvements in their anxiety levels over time ( P = 0.009 and 0.006 in the third and sixth months , respectively ) and depression ( P = 0.00006 and 0.004 in the third and sixth months , respectively ) than did the usual-care group patients .
-CONCLUSIONS	The home-based walking exercise programme is a feasible and effective intervention method for managing anxiety and depression in lung cancer survivors and can be considered as an essential component of lung cancer rehabilitation .
-
-###25552280
-OBJECTIVE	To determine whether re-feeding of gastric residual volumes reduces the time needed to achieve full enteral feeding in preterm infants .
-METHODS	Parallel-group randomised controlled trial with a 1:1 allocation ratio .
-METHODS	Regional referral neonatal intensive care unit .
-METHODS	72 infants of gestational age 23 ( 0/7 ) to 28 ( 6/7 ) weeks receiving minimal enteral nutrition ( < 24 mL/kg/day ) during the first week after birth .
-METHODS	Infants were randomised to either be re-fed with gastric residual volumes ( Re-feeding group ) or receive fresh formula/human milk ( Fresh-feeding group ) whenever large gastric residual volumes were noted .
-METHODS	The primary efficacy end point was time to achieve full enteral feeding ( 120 mL/kg/day ) after randomisation .
-RESULTS	The mean time to full enteral feeding was 10.0 days in the Re-feeding group and 11.3 days in the Fresh-feeding group ( mean difference favouring re-feeding : -1.3 days ; 95 % CI -2.9 to 0.3 ; p = 0.11 ) .
-RESULTS	The composite safety end point of spontaneous intestinal perforation , surgical necrotising enterocolitis , or death occurred in 6 of 36 infants ( 17 % ) in the Re-feeding group versus 10 of 36 infants ( 28 % ) in the Fresh-feeding group ( p = 0.26 ) .
-CONCLUSIONS	Re-feeding gastric residual volumes in extremely preterm infants does not reduce time to achieve full enteral feeding .
-CONCLUSIONS	This trial suggests that re-feeding might be as safe as fresh feeding , but further research is needed , due to lack of sufficient statistical power in this study for safety analysis .
-BACKGROUND	NCT01420263NCT01420263 .
-
-###24306710
-BACKGROUND	Examination of arthroscopic skill requires evaluation tools that are valid and reliable with clear criteria for passing .
-BACKGROUND	The Arthroscopic Surgery Skill Evaluation Tool was developed as a video-based assessment of technical skill with criteria for passing established by a panel of experts .
-BACKGROUND	The purpose of this study was to test the validity and reliability of the Arthroscopic Surgery Skill Evaluation Tool as a pass-fail examination of arthroscopic skill .
-METHODS	Twenty-eight residents and two sports medicine faculty members were recorded performing diagnostic knee arthroscopy on a left and right cadaveric specimen in our arthroscopic skills laboratory .
-METHODS	Procedure videos were evaluated with use of the Arthroscopic Surgery Skill Evaluation Tool by two raters blind to subject identity .
-METHODS	Subjects were considered to pass the Arthroscopic Surgery Skill Evaluation Tool when they attained scores of 3 on all eight assessment domains .
-RESULTS	The raters agreed on a pass-fail rating for fifty-five of sixty videos rated with an interclass correlation coefficient value of 0.83 .
-RESULTS	Ten of thirty participants were assigned passing scores by both raters for both diagnostic arthroscopies performed in the laboratory .
-RESULTS	Receiver operating characteristic analysis demonstrated that logging more than eighty arthroscopic cases or performing more than thirty-five arthroscopic knee cases was predictive of attaining a passing Arthroscopic Surgery Skill Evaluation Tool score on both procedures performed in the laboratory .
-CONCLUSIONS	The Arthroscopic Surgery Skill Evaluation Tool is valid and reliable as a pass-fail examination of diagnostic arthroscopy of the knee in the simulation laboratory .
-CONCLUSIONS	This study demonstrates that the Arthroscopic Surgery Skill Evaluation Tool may be a useful tool for pass-fail examination of diagnostic arthroscopy of the knee in the simulation laboratory .
-CONCLUSIONS	Further study is necessary to determine whether the Arthroscopic Surgery Skill Evaluation Tool can be used for the assessment of multiple arthroscopic procedures and whether it can be used to evaluate arthroscopic procedures performed in the operating room .
-
-###24617349
-OBJECTIVE	To determine effect of change in urine excretion of isoflavonoids on cognitive change .
-METHODS	Post hoc analysis of isoflavonoid exposure ( mean 2.7 years ) during the randomized , placebo-controlled , double-blind Women 's Isoflavone Soy Health trial .
-METHODS	General community .
-METHODS	Healthy postmenopausal women ( N = 350 ) .
-METHODS	Twenty-five grams of isoflavone-rich soy protein ( 91 mg of aglycone weight isoflavones : 52 mg genistein , 36 mg daidzein , 3 mg glycitein ) or milk protein-matched placebo provided daily .
-METHODS	Overnight urine excretion , fasting plasma levels of isoflavonoids , and cognitive function measured at baseline and endpoint .
-RESULTS	Three hundred women ( age : mean 61 , range 45-92 ) completed both cognitive assessments and did not use hormone replacement therapy during the trial .
-RESULTS	Mean on-trial change from baseline in urine excretion of isoflavonoids was not significantly associated with change in a composite score of global cognition ( P = .39 ) .
-RESULTS	Secondary analyses indicated that change in urine excretion of isoflavonoids was inversely associated with change in a factor score representing general intelligence ( P = .02 ) but not with factor scores representing verbal or visual episodic memory .
-RESULTS	Mean differences in this general intelligence factor score between women in the lowest and highest quartiles of isoflavonoid change were equivalent to an approximate 4.4-year age-associated decline .
-RESULTS	Analyses based on plasma isoflavonoid levels yielded similar but attenuated results .
-CONCLUSIONS	In healthy postmenopausal women , long-term changes in isoflavonoids are not associated with global cognition , supporting clinical trial results , although greater isoflavonoid exposure from dietary supplements is associated with decrements in general intelligence but not memory ; this finding requires confirmation in future studies .
-
-###25575258
-OBJECTIVE	To investigate the therapeutic value of Gastrografin in shortening duration of prolonged postoperative ileus ( PPOI ) after elective colorectal surgery .
-BACKGROUND	Gut wall edema is central to the pathogenesis of PPOI .
-BACKGROUND	Hyperosmotic , orally administered , water-soluble contrast media such as Gastrografin are theoretically capable of mitigating this edema .
-METHODS	A double-blinded , placebo-controlled , randomized trial was conducted .
-METHODS	Participants were allocated to receive 100 mL of Gastrografin ( Exposure Group ) or flavored distilled water ( Control Group ) administered enterally .
-METHODS	Other aspects of management were standardized .
-METHODS	Resolution of PPOI was assessed 12-hourly .
-RESULTS	Eighty patients were randomized equally , with 5 in the Exposure Group and 4 in the Control Group excluded from analysis .
-RESULTS	Participants were evenly matched at baseline .
-RESULTS	Mean duration of PPOI did not differ between Exposure and Control Groups ( 83.7 vs 101.3 hours ; P = 0.191 ) .
-RESULTS	When considering individual markers of PPOI resolution , Gastrografin did not affect time to resolution of nausea and vomiting ( 64.5 vs 74.3 hours ; P = 0.404 ) or consumption of oral diet ( 75.8 vs 90.0 hours ; P = 0.297 ) .
-RESULTS	However , it accelerated time to flatus or stool ( 18.9 vs 32.7 hours ; P = 0.047 ) and time to resolution of abdominal distension ( 52.8 vs 77.7 hours ; P = 0.013 ) .
-RESULTS	There were no significant differences between groups in nasogastric output ; analgesia , antiemetic , or fluid requirement ; complications ; or length of stay .
-CONCLUSIONS	Gastrografin is not clinically useful in shortening an episode of PPOI characterized by upper and lower gastrointestinal symptoms .
-CONCLUSIONS	It may however be of therapeutic benefit in the subset of PPOI patients who display lower gastrointestinal symptoms exclusively after surgery .
-
-###25555191
-OBJECTIVE	A randomized clinical trial is needed to evaluate what is the best photodynamic therapy ( PDT ) protocol to use for acute central serous chorioretinopathy .
-OBJECTIVE	To compare the efficacy and safety of a 50 % dose of verteporfin ( a method of PDT ) with the efficacy and safety of a 30 % dose for acute central serous chorioretinopathy .
-METHODS	A multicenter , noninferiority , double-masked , randomized , controlled , clinical trial in which 131 patients ( 131 eyes ) with acute central serous chorioretinopathy for less than 6 months were recruited with a follow-up of 12 months from university-based ophthalmology practices .
-METHODS	Patients were randomly assigned to either a 50 % dose of verteporfin ( the 50 % - dose PDT group ) or a 30 % dose ( the 30 % - dose PDT group ) .
-METHODS	The 2 primary outcome measures were the proportion of eyes with complete absorption of subretinal fluid and the proportion of eyes with complete disappearance of fluorescein leakage at 6 and 12 months .
-METHODS	The secondary outcome measures included the subretinal fluid recurrent rate , the fluorescein leakage recurrent rate at 12 months , the mean best-corrected visual acuity , the retinal thickness of the foveal center , and the maximum retinal thickness at each scheduled visit .
-RESULTS	The noninferiority of the 30 % - dose PDT compared with the 50 % - dose PDT for the primary outcomes was not demonstrated .
-RESULTS	The optical coherence tomography-based improvement rate in the 30 % - dose PDT group was less than that in the 50 % - dose PDT group both at 6 months ( 73.8 % vs 92.9 % ; = 0.0125 , P = .006 ) and at 12 months ( 75.4 % vs 94.6 % ; = 0.0125 , P = .004 ) .
-RESULTS	The fluorescein angiography-based improvement rate in the 30 % - dose PDT group was less than that in the 50 % - dose PDT group both at 6 months ( 68.9 % vs 91.1 % ; = 0.0125 , P = .003 ) and at 12 months ( 68.9 % vs 92.9 % ; = 0.0125 , P = .001 ) .
-RESULTS	The subretinal fluid recurrence rate in the 30 % - dose PDT group was greater than that in the 50 % - dose PDT group ( 24.0 % vs 5.7 % at 12 months ; P = .010 , determined by use of the log-rank test ) .
-RESULTS	The fluorescein leakage recurrent rate in the 30 % - dose PDT group was significantly higher than that in the 50 % - dose PDT group ( 16.7 % vs 3.8 % at 12 months ; P = .03 , determined by use of the log-rank test ) .
-RESULTS	No ocular adverse event was encountered in the study .
-CONCLUSIONS	A 50 % dose of verteporfin may be more effective at resolving subretinal fluid and fluorescein leakage , and with better visual outcomes , than a 30 % dose for acute central serous chorioretinopathy .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01574430 .
-
-###25632625
-BACKGROUND	Conventional Valsalva maneuver ( CV ) is a standardprocedure to exhibit reverse venous flow atsaphenofemoral junction ( SFJ ) by duplex ultrasonography ( DUS ) .
-BACKGROUND	However some patients could not undergo CV during examination .
-OBJECTIVE	Compare blowing party balloon assisted Valsalva ( PBAV ) with CV for exhibiting the reverse venous flow at SFJ incompetence .
-METHODS	Forty patients who had symptoms and signs of suspected saphenofemoral junction incompetence were examined for venous reflux by DUS with two techniques of Valsalva maneuver PBAV and CV The design was a 2x2 cross-over study .
-METHODS	The patients were randomized to two sequences .
-METHODS	The first sequence performed CV before PBAV The second sequence performed PBAV before CV The timing for the instruction , reflux time , and total timing of examination were compared between the two sequences .
-RESULTS	There was neither period effect nor treatment-period interaction .
-RESULTS	Both PBAV and CV could equally identify SFJ reflux , but teaching time and total examination time in PBAV was shorter than CV .
-CONCLUSIONS	PBAV is a new option to exhibit reverse venous flow at SFJ by DUS .
-CONCLUSIONS	PBAV is easier and spend less time than CV
-
-###24661040
-BACKGROUND	Obesity has long been associated with psoriasis and it is considered to be an independent risk factor for chronic heart diseases in these patients .
-BACKGROUND	Recently , some of the biologic drugs used for psoriasis have been reported to cause increase in body weight .
-BACKGROUND	It is currently not clear if this increased body weight seen in psoriasis patients on biologics leads to decrease in there efficacy or vice versa .
-BACKGROUND	We carried out this study to see if reduction in body weight leads to increased efficacy of biologics in obese psoriasis patients .
-OBJECTIVE	To evaluate the effect of weight reduction by dietary control on treatment efficacy of biologics in obese patients as indicated by the Psoriasis Area and Severity Index ( PASI ) score .
-METHODS	Obese patients with psoriasis receiving biologic therapy , satisfying the inclusion criterion , were randomized in a 1:1 ratio to receive low-calorie diet versus normal diet ( control group ) .
-METHODS	We included 262 patients with moderate to severe , stable plaque psoriasis with a PASI score 20:50 on anti TNF - biologic therapy ( infliximab , etanercept , ustekinumab and adalimumab ) .
-METHODS	The patients in the dietary intervention group were given a low calorie diet ( 1000 kcal per day ) for 8 weeks to induce weight loss .
-METHODS	The treatment outcome was assessed using PASI .
-METHODS	The PASI scores were assessed at baseline and every 4 weeks up to week 24 .
-RESULTS	There were no significant differences in age , sex distribution , body weight , body mass index , waist circumference , psoriasis duration , or PASI score between the two studied groups at base line .
-RESULTS	At week 24 , the mean ( SD ) weight loss was 12.9 1.2 kg in the diet intervention group , and -1.5 0.5 kg in the control group .
-RESULTS	The average improvement in mean PASI score was 84 % for the diet group , and 69 % for the control group .
-RESULTS	PASI 75 was achieved by 85.9 % in the diet group , and 59.3 % in the control group ( p < 0.001 ) .
-RESULTS	The mean ( SD ) body surface area values at week 24 were 3.3 4.4 % and 8.1 6.9 % in the diet group and control group .
-CONCLUSIONS	Body weight reduction in obese patients on biologics may increase the efficacy of the drug .
-
-###24788589
-BACKGROUND	Antenatal depression and anxiety are associated with adverse obstetric and mental health outcomes , yet practicable nonpharmacological therapies , particularly for the latter , are lacking .
-BACKGROUND	Yoga incorporates relaxation and breathing techniques with postures that can be customized for pregnant women .
-BACKGROUND	This study tested the efficacy of yoga as an intervention for reducing maternal anxiety during pregnancy .
-METHODS	Fifty-nine primiparous , low-risk pregnant women completed questionnaires assessing state ( State Trait Anxiety Inventory ; STAI-State ) , trait ( STAI-Trait ) , and pregnancy-specific anxiety ( Wijma Delivery Expectancy Questionnaire ; WDEQ ) and depression ( Edinburgh Postnatal Depression Scale ; EPDS ) before randomization ( baseline ) to either an 8-week course of antenatal yoga or treatment-as-usual ( TAU ) ; both groups repeated the questionnaires at follow-up .
-METHODS	The yoga group also completed pre - and postsession state anxiety and stress hormone assessments at both the first and last session of the 8-week course .
-RESULTS	A single session of yoga reduced both subjective and physiological measures of state anxiety ( STAI-S and cortisol ) ; and this class-induced reduction in anxiety remained at the final session of the intervention .
-RESULTS	Multiple linear regression analyses identified allocation to yoga as predictive of greater reduction in WDEQ scores ( B = -9.59 ; BCa 95 % CI = -18.25 to -0.43 ; P = .014 ; d = -0.57 ) , while allocation to TAU was predictive of significantly increased elevation in EPDS scores ( B = -3.06 ; BCa 95 % CI = -5.9 to -0.17 ; P = .042 ; d = -0.5 ) .
-RESULTS	No significant differences were observed in state or trait anxiety scores between baseline and follow-up .
-CONCLUSIONS	Antenatal yoga seems to be useful for reducing women 's anxieties toward childbirth and preventing increases in depressive symptomatology .
-
-###24752177
-BACKGROUND	Vitamin D has wide-ranging effects on the immune system , and studies suggest that low serum vitamin D levels are associated with worse clinical outcomes in HIV .
-BACKGROUND	Recent studies have identified an interaction between antiretrovirals used to treat HIV and reduced serum vitamin D levels , but these studies have been done in North American and European populations .
-METHODS	Using a prospective cohort study design nested in a multinational clinical trial , we examined the effect of three combination antiretroviral ( cART ) regimens on serum vitamin D levels in 270 cART-nave , HIV-infected adults in nine diverse countries , ( Brazil , Haiti , Peru , Thailand , India , Malawi , South Africa , Zimbabwe and the United States ) .
-METHODS	We evaluated the change between baseline serum vitamin D levels and vitamin D levels 24 and 48 weeks after cART initiation .
-RESULTS	Serum vitamin D levels decreased significantly from baseline to 24 weeks among those randomized to efavirenz/lamivudine/zidovudine ( mean change : -7.94 [ 95 % Confidence Interval ( CI ) -10.42 , -5.54 ] ng/ml ) and efavirenz/emtricitabine/tenofovir-DF ( mean change : -6.66 [ 95 % CI -9.40 , -3.92 ] ng/ml ) when compared to those randomized to atazanavir/emtricitabine/didanosine-EC ( mean change : -2.29 [ 95 % CI -4.83 , 0.25 ] ng/ml ) .
-RESULTS	Vitamin D levels did not change significantly between week 24 and 48 .
-RESULTS	Other factors that significantly affected serum vitamin D change included country ( p < 0.001 ) , season ( p < 0.001 ) and baseline vitamin D level ( p < 0.001 ) .
-CONCLUSIONS	Efavirenz-containing cART regimens adversely affected vitamin D levels in patients from economically , geographically and racially diverse resource-limited settings .
-CONCLUSIONS	This effect was most pronounced early after cART initiation .
-CONCLUSIONS	Research is needed to define the role of Vitamin D supplementation in HIV care .
-
-###25012408
-BACKGROUND	A collaborative care programme for depression in primary care has proven clinical effectiveness over a 12-months period .
-BACKGROUND	Because depression tends to relapse and to chronic course , our aim was to determine whether the effectiveness observed in the first year persists during 3 years of monitoring .
-METHODS	Randomised controlled trial with twenty primary care centres were allocated to intervention group or usual care group .
-METHODS	The intervention consisted of a collaborative care programme with clinical , educational and organisational procedures .
-METHODS	Outcomes were monitored by a blinded interviewer at baseline , 12 and 36 months .
-METHODS	Clinical outcomes were response to treatment and remission rates , depression severity and health-related quality of life .
-BACKGROUND	ISRCTN16384353 .
-RESULTS	A total of 338 adult patients with major depression ( DSM-IV ) were assessed at baseline .
-RESULTS	At 36 months , 137 patients in the intervention group and 97 in the control group were assessed ( attrition 31 % ) .
-RESULTS	The severity of depression ( mean Patient Health Questionnaire-9 score ) was 0.95 points lower in the intervention group [ 6.31 versus 7.25 ; p = 0.324 ] .
-RESULTS	The treatment response rate was 5.6 % higher in the intervention group than in the control group [ 66.4 % versus 60.8 % ; p = 0.379 ] and the remission rate was 9.2 % higher [ 57.7 % versus 48.5 % ; p = 0.164 ] .
-RESULTS	No difference reached statistical significance .
-CONCLUSIONS	The number of patients lost ( 31 % ) before follow-up may have introduced a bias .
-CONCLUSIONS	Clinical benefits shown in the first year were not maintained beyond : at 36 months the differences between the control group and the intervention group reduced in all the analysed variables .
-
-###25428209
-BACKGROUND	The Carotid Revascularization Endarterectomy Versus Stenting Trial ( CREST ) is a multicenter randomized trial of stenting versus endarterectomy in patients with symptomatic and asymptomatic carotid disease .
-BACKGROUND	This study assesses management of vascular risk factors .
-RESULTS	Management was provided by the patient 's physician , with biannual monitoring results collected by the local site .
-RESULTS	Therapeutic targets were low-density lipoprotein , cholesterol < 100 mg/dL , systolic blood pressure < 140 mm Hg , fasting blood glucose < 126 mg/dL , and nonsmoking status .
-RESULTS	Optimal control was defined as achieving all 4 goals concurrently .
-RESULTS	Generalized estimating equations were used to compare risk factors at baseline with those observed in scheduled follow-up visits for up to 48 months .
-RESULTS	In the analysis cohort of 2210 , significant improvements in risk-factor control were observed across risk factors for all follow-up visits compared with baseline .
-RESULTS	At 48 months , achievement of the low-density lipoprotein cholesterol goal improved from 59.1 % to 73.6 % ( P < 0.001 ) , achievement of the systolic blood pressure goal improved from 51.6 % to 65.1 % ( P < 0.001 ) , achievement of the glucose goal improved from 74.9 % to 80.7 % ( P = 0.0101 ) , and nonsmoking improved from 74.4 % to 80.9 % ( P < 0.0001 ) .
-RESULTS	The percentage with optimal risk-factor control also improved significantly , from 16.7 % to 36.2 % ( P < 0.001 ) , but nearly 2 of 3 study participants did not achieve optimal control during the study .
-CONCLUSIONS	Site-based risk-factor control improved significantly in the first 6 months and over the long term in CREST but was often suboptimal .
-CONCLUSIONS	Intensive medical management should be considered for future trials of carotid revascularization .
-BACKGROUND	ClinicalTrials.gov .
-BACKGROUND	Unique identifier : NCT00004732 .
-
-###26390721
-OBJECTIVE	To analyze the efficiency of the ALL-2009 protocol ( ClinicalTrials.gov NCT01 193933 ) in patients with T-cell leukemias , particularly the role of autologous hematopoietic stem cell transplantation ( auto-HSCT ) after non-myeloablative BEAM conditioning , followed by maintenance therapy .
-METHODS	Since 2009 , the ALL-2009 study has enrolled 90 patients with T-cell acute lymphoblastic leukemia ( T-ALL ) , the treatment results were assessed in 86 patients : 6 and 28 patients underwent allogeneic HSCT and auto-HSCT , respectively .
-METHODS	A landmark analysis was used to compare survival rates in patients who had undergone auto-HSCT and in those who had not .
-METHODS	For this , the median time from complete remission to the date of auto-HSCT was determined ( the median was 6 months ) .
-METHODS	Then to compare with the auto-HSCT group , only 27 patients who had been in complete remission for 6 months or more were included in a chemotherapy group .
-RESULTS	The achievement of complete remission in patients with thymic T-ALL ( 100 % ) was significantly higher than in those with early ( 85.7 % ) or mature ( 70 % ) variants .
-RESULTS	The patients with early and mature T-ALL as compared to those with thymic T-ALL showed high death rates in the remission induction ( 7.4 and 10 % versus 0 ) and the patients with mature T-ALL had a.higher proportion of refractory forms ( 20 % versus 0 ) .
-RESULTS	The 5-year overall and relapse-free survival rates in all the T-ALL patients were 66 and 76 % , respectively .
-RESULTS	After auto-HSCT , the risk of recurrence was 0 % versus 21 % after chemotherapy ( p = 0.03 ) .
-RESULTS	The relapse-free survival rates significantly differed in the auto-HSCT and non-auto-HSCT groups : 100 and 66 % , respectively ( p = 0.047 ) .
-CONCLUSIONS	The long-term survival rates obtained during this multicenter study in the T-ALL patients treated according to the ALL-2009 protocol , the basis for which is the principle of continuity of cytostatic effects , are exclusively optimistic .
-CONCLUSIONS	Late consolidation with auto-HSCT following non-myeloablative BEAM conditioning , followed by maintenance therapy , considerably reduces the risk of recurrence .
-
-###26111066
-OBJECTIVE	Orphans and vulnerable children ( OVC ) are at high risk for experiencing trauma and related psychosocial problems .
-OBJECTIVE	Despite this , no randomized clinical trials have studied evidence-based treatments for OVC in low-resource settings .
-OBJECTIVE	To evaluate the effectiveness of lay counselor-provided trauma-focused cognitive behavioral therapy ( TF-CBT ) to address trauma and stress-related symptoms among OVC in Lusaka , Zambia .
-METHODS	This randomized clinical trial compared TF-CBT and treatment as usual ( TAU ) ( varying by site ) for children recruited from August 1 , 2012 , through July 31 , 2013 , and treated until December 31 , 2013 , for trauma-related symptoms from 5 community sites within Lusaka , Zambia .
-METHODS	Children were aged 5 through 18 years and had experienced at least one traumatic event and reported significant trauma-related symptoms .
-METHODS	Analysis was with intent to treat .
-METHODS	The intervention group received 10 to 16 sessions of TF-CBT ( n = 131 ) .
-METHODS	The TAU group ( n = 126 ) received usual community services offered to OVC .
-METHODS	The primary outcome was mean item change in trauma and stress-related symptoms using a locally validated version of the UCLA Posttraumatic Stress Disorder Reaction Index ( range , 0-4 ) and functional impairment using a locally developed measure ( range , 0-4 ) .
-METHODS	Outcomes were measured at baseline and within 1 month after treatment completion or after a waiting period of approximately 4.5 months after baseline for TAU .
-RESULTS	At follow-up , the mean item change in trauma symptom score was -1.54 ( 95 % CI , -1.81 to -1.27 ) , a reduction of 81.9 % , for the TF-CBT group and -0.37 ( 95 % CI , -0.57 to -0.17 ) , a reduction of 21.1 % , for the TAU group .
-RESULTS	The mean item change for functioning was -0.76 ( 95 % CI , -0.98 to -0.54 ) , a reduction of 89.4 % , and -0.54 ( 95 % CI , -0.80 to -0.29 ) , a reduction of 68.3 % , for the TF-CBT and TAU groups , respectively .
-RESULTS	The difference in change between groups was statistically significant for both outcomes ( P < .001 ) .
-RESULTS	The effect size ( Cohen d ) was 2.39 for trauma symptoms and 0.34 for functioning .
-RESULTS	Lay counselors participated in supervision and assessed whether the intervention was provided with fidelity in all 5 community settings .
-CONCLUSIONS	The TF-CBT adapted for Zambia substantially decreased trauma and stress-related symptoms and produced a smaller improvement in functional impairment among OVC having experienced high levels of trauma .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01624298 .
-
-###24440102
-OBJECTIVE	To compare the astigmatism-reducing effect of a toric intraocular lens ( IOL ) and peripheral corneal relaxing incisions ( PCRIs ) .
-METHODS	Moorfields Eye Hospital NHS Foundation Trust , London , United Kingdom .
-METHODS	Prospective masked bilateral randomized study .
-METHODS	Cataract patients with a preoperative corneal astigmatism of 1.0 to 2.5 diopters ( D ) were included .
-METHODS	All patients received a toric IOL in 1 eye and a nontoric IOL plus a PCRI in the other eye .
-METHODS	Postoperative follow-up was at 1 hour , 1 month , and 6 months .
-METHODS	The uncorrected distance visual acuity , corrected distance visual acuity , autorefraction ( Topcon RM-8800 ) , and subjective refraction were recorded .
-METHODS	The IOL axis was assessed using retroillumination photographs .
-RESULTS	The study enrolled 60 eyes of 30 patients .
-RESULTS	The mean astigmatism vector reduction was 1.74 D 0.64 ( SD ) in the toric IOL group and 1.27 0.76 D in the PCRI group ; the difference was statistically significant ( P = .042 ) .
-RESULTS	The mean absolute rotation of the toric IOL was 2.5 1.8 degrees ( maximum 6.3 degrees ) in the first 6 postoperative months .
-RESULTS	Astigmatism increased in the PCRI group between the 1-month and 6-month follow-up ( mean 0.38 0.27 D ; maximum 1.00 D ) ( P < .001 ) .
-CONCLUSIONS	Toric IOLs and PCRIs both reduced astigmatism ; however , toric IOLs reduced astigmatism to a higher extent and they were more predictable .
-
-###24372225
-OBJECTIVE	To evaluate the long-term efficacy and safety of certolizumab pegol ( CZP ) treatment and to assess the efficacy of two CZP maintenance dosing schedules in Japanese rheumatoid arthritis ( RA ) patients who could not receive methotrexate ( MTX ) .
-METHODS	HIKARI double-blind ( DB ) patients were entered into an open-label extension ( OLE ) study .
-METHODS	Patients withdrawn at 16 weeks due to lack of efficacy and DB completers without a 24-week American College of Rheumatology ( ACR ) 20 response received CZP 200 mg every 2 weeks ( Q2W ) .
-METHODS	DB completers with 24-week ACR20 responses were randomized to CZP 200 mg Q2W or CZP 400 mg every 4 weeks .
-RESULTS	The ACR20/ACR50/ACR70 response rates of DB completers ( n = 98 ) were 82.7 % / 56.1 % / 34.7 % at OLE entry , and 83.7 % / 65.3 % / 48.0 % at 52 weeks , respectively .
-RESULTS	Other clinical , functional , and radiographic outcomes were sustained during long-term administration of CZP , even without MTX .
-RESULTS	No new unexpected adverse events were observed during long-term CZP treatment .
-RESULTS	The efficacy and safety of CZP treatment were similar between the two dosing schedules .
-CONCLUSIONS	Long-term CZP administration is efficacious and safe for RA patients .
-CONCLUSIONS	No obvious differences in clinical efficacy and safety were observed between the two dosing schedules .
-CONCLUSIONS	The choice between two maintenace regimens adds flexibility in administration schedules for RA patients and physicians .
-
-###25285367
-OBJECTIVE	To compare the 24-h changes of intraocular pressure ( IOP ) and mean ocular perfusion pressure ( MOPP ) obtained with tafluprost versus travoprost in patients with normal-tension glaucoma ( NTG ) .
-METHODS	This study is a randomized crossover study of 50 patients newly diagnosed with NTG who received either tafluprost or travoprost given once at 9 PM for 2 months , after which they were crossed over to the other medication for another 2 months .
-METHODS	IOP and blood pressure were measured for 24h before starting the treatment and after finishing the first and second treatment periods .
-RESULTS	Forty-one patients completed the study .
-RESULTS	The mean ( standard deviation ) 24-h IOP was 16.82.0 mmHg at baseline , 14.42.2 mmHg on tafluprost , and 13.61.8 mmHg on travoprost .
-RESULTS	Both prostaglandin monotherapies significantly reduced mean 24-h IOP as compared with baseline ( P < 0.001 , P < 0.001 , respectively ) , and travoprost demonstrated a lower mean 24-h IOP than tafluprost ( P = 0.044 ) .
-RESULTS	Both treatments significantly reduced the IOP from baseline at every point over 24h .
-RESULTS	At 3 individual time points , travoprost provided a lower IOP than tafluprost : at 4 PM ( 13.82.7 vs. 14.82.6 mmHg , P = 0.041 ) , at 6 PM ( 13.52.5 vs. 14.42.5 mmHg , P = 0.006 ) , and at 8 PM ( 13.32.5 vs. 14.52.4 mmHg , P = 0.029 ) .
-RESULTS	Both tafluprost and travoprost significantly increased the 24-h MOPP ( P = 0.008 , P = 0.002 , respectively ) , and travoprost demonstrated a greater 24-h MOPP than tafluprost ( P = 0.027 ) .
-CONCLUSIONS	Both tafluprost and travoprost were effective in lowering IOP and increasing MOPP throughout 24h in NTG .
-CONCLUSIONS	However , travoprost reduced IOP greater than tafluprost in the late afternoon and evening .
-
-###24535415
-OBJECTIVE	Guanidinoacetic acid ( GAA ) is an intermediate in the biosynthesis of creatine ( Cr ) , yet its use in human nutrition is limited due to a lack of a clear understanding of its ' dose-response effect .
-OBJECTIVE	Thus , the purpose of this study was to investigate the effect of three different dosages of GAA ( 1.2 , 2.4 and 4.8 g/day ) administered for 6 weeks on serum and urinary variables related to GAA metabolism .
-METHODS	Forty-eight healthy volunteers participated in the randomized , placebo-controlled , double-blind , repeated-measure study .
-METHODS	At baseline , after 1 , 2 , 4 and 6 weeks , participants provided both fasting blood samples and 24-h urine .
-RESULTS	GAA intervention significantly increased serum and urinary GAA , Cr and creatinine as compared to placebo ( P < 0.05 ) .
-RESULTS	Differences were found for serum GAA and Cr responses between the three GAA dosages , with high-dose GAA resulting in a greater increase ( P < 0.05 ) in the plasma concentration of both variables as compared to other GAA dosages .
-RESULTS	In GAA groups , fasting plasma total homocysteine ( T-Hcy ) increased by 3.5 mol/L on average at post-administration , yet no dose-response differences were found between trials .
-RESULTS	Serum B vitamins were not affected by either placebo or GAA intervention ( P > 0.05 ) .
-CONCLUSIONS	Results indicate that low-to-high dosages of exogenous GAA can increase serum concentrations of Cr and T-Hcy while not depleting the B vitamins pool available for remethylation of homocysteine .
-BACKGROUND	ClinicalTrials.gov , identification number NCT01133899 .
-
-###25204231
-OBJECTIVE	The objective of this trial was to assess which type of warm-up has the highest effect on virtual reality ( VR ) laparoscopy performance .
-OBJECTIVE	The following warm-up strategies were applied : a hands-on exercise ( group 1 ) , a cognitive exercise ( group 2 ) , and no warm-up ( control , group 3 ) .
-METHODS	This is a 3-arm randomized controlled trial .
-METHODS	The trial was conducted at the department of surgery of the University Hospital Basel in Switzerland .
-METHODS	A total of 94 participants , all laypersons without any surgical or VR experience , completed the study .
-RESULTS	A total of 96 participants were randomized , 31 to group 1 , 31 to group 2 , and 32 to group 3 .
-RESULTS	There were 2 postrandomization exclusions .
-RESULTS	In the multivariate analysis , we found no evidence that the intervention had an effect on VR performance as represented by 6 calculated subscores of accuracy , time , and path length for ( 1 ) camera manipulation and ( 2 ) hand-eye coordination combined with 2-handed maneuvers ( p = 0.795 ) .
-RESULTS	Neither the comparison of the average of the intervention groups ( groups 1 and 2 ) vs control ( group 3 ) nor the pairwise comparisons revealed any significant differences in VR performance , neither multivariate nor univariate .
-RESULTS	VR performance improved with increasing performance score in the cognitive exercise warm-up ( iPad 3D puzzle ) for accuracy , time , and path length in the camera navigation task .
-CONCLUSIONS	We were unable to show an effect of the 2 tested warm-up strategies on VR performance in laypersons .
-CONCLUSIONS	We are currently designing a follow-up study including surgeons rather than laypersons with a longer warm-up exercise , which is more closely related to the final task .
-
-###24887458
-BACKGROUND	The purpose of this study was to retrospectively explore the relationship between human epidermal growth factor receptor 2 ( HER2 ) messenger RNA ( mRNA ) expression and efficacy in patients receiving trastuzumab plus docetaxel ( HT ) or trastuzumab emtansine ( T-DM1 ) .
-METHODS	Patients with HER2-positive , locally advanced or metastatic breast cancer ( MBC ) were randomly assigned to HT ( n = 70 ) or T-DM1 ( n = 67 ) .
-METHODS	HER2 status was assessed locally using immunohistochemistry or fluorescence in situ hybridization and confirmed retrospectively by central testing .
-METHODS	HER2 mRNA expression was assessed using quantitative reverse transcriptase polymerase chain reaction .
-RESULTS	HER2 mRNA levels were obtained for 116/137 patients ( HT = 61 ; T-DM1 = 55 ) .
-RESULTS	Median pretreatment HER2 mRNA was 8.9 .
-RESULTS	The risk of disease progression in the overall population was lower with T-DM1 than with HT ( hazard ratio ( HR ) = 0.59 ; 95 % confidence interval ( CI ) 0.36 to 0.97 ) .
-RESULTS	This effect was more pronounced in patients with HER2 mRNAmedian ( HR = 0.39 ; 95 % CI 0.18 to 0.85 ) versus < median ( HR = 0.85 ; 95 % CI 0.44 to 1.67 ) .
-RESULTS	In the T-DM1 arm , median progression-free survival ( PFS ) was not reached in patients with HER2 mRNAmedian and was 10.6 months in patients with HER2 mRNA < median .
-RESULTS	In the HT arm , PFS was 8.8 versus 9.8 months in patients with HER2 mRNAmedian versus < median , respectively .
-RESULTS	The effect of HER2 mRNA expression on objective response rates was less pronounced .
-CONCLUSIONS	This exploratory analysis suggests that while overall , patients with HER2-positive MBC show improved PFS with T-DM1 relative to HT , the effect is enhanced in patients with tumor HER2 mRNAmedian .
-BACKGROUND	ClinicalTrials.gov NCT00679341 .
-
-###24279738
-BACKGROUND	The behavioral outcome of food ingestion is a complex process that involves psychological and biological factors .
-BACKGROUND	Avocados are nutrient dense with properties that may favorably impact energy balance .
-BACKGROUND	This study sought to evaluate if incorporating approximately one half of a Hass avocado by addition or inclusion into a lunch meal will influence post-ingestive satiety , glucose and insulin response , and subsequent energy intake among overweight adults .
-METHODS	This was a randomized 33 single-blind crossover design study with 26 healthy overweight adults ( mean SD age 40.811.0 years and BMI 28.12.4 kg/m ) .
-METHODS	Participants consumed a standardized breakfast followed by 1 of 3 lunch test meals [ Control ( C ) , avocado-free ; Avocado Inclusive ( AI ) ; and , Avocado Added ( AA ) ] .
-METHODS	Participants rated five appetite sensations using a visual analog scale ( VAS ) before lunch and at specific intervals over 5 hours following the start of the test meal .
-METHODS	Blood glucose and insulin were measured before lunch and at specific intervals over 3 hours following the start of the test meal .
-METHODS	Mixed models were used to compare differences among the 3 test meals , and the area under the curve ( AUC ( 0-xh ) ) was computed for the VAS and biological measures .
-RESULTS	There were significant differences in the AUC ( 0-5h ) for the self-reported feelings of satisfaction ( P = 0.04 ) and desire to eat ( P = 0.05 ) in the mixed model analysis .
-RESULTS	Compared to the C test meal , the AA test meal increased satisfaction by 23 % ( P = 0.05 ) and decreased the desire to eat by 28 % ( P = 0.04 ) for the AUC ( 0-5h ) .
-RESULTS	For the AUC ( 0-3h ) , the AA test meal increased satisfaction by 26 % ( P = 0.02 ) and decreased the desire to eat by 40 % ( P = 0.01 ) as compared to the C test meal .
-RESULTS	Compared to the AI meal , the AUC ( 0-3h ) for blood insulin was higher in the C and AA meals ( P = 0.04 and P = 0.05 , respectively ) .
-CONCLUSIONS	The addition of approximately one half of a Hass avocado at a lunch meal can influence post-ingestive satiety over a subsequent 3 and 5 hour period in overweight adults .
-CONCLUSIONS	A caveat to these findings is that the avocado contained an additional 112 kcal , which may have accounted for the observed increase in satisfaction and decreased desire to eat .
-CONCLUSIONS	Future trials are warranted to evaluate the effects of avocado intake on weight management in adults of varying BMIs and among insulin resistant individuals .
-
-###24785954
-OBJECTIVE	We explored associations between mitochondrial DNA ( mtDNA ) haplogroups , epidermal nerve fiber density ( ENFD ) , and HIV-associated sensory neuropathy ( HIV-SN ) in a randomized trial of Thai patients initiating antiretroviral therapy ( ART ) .
-METHODS	The South East Asia Research Collaboration with Hawaii 003 study evaluated toxicity of nucleoside reverse transcriptase inhibitors ( stavudine vs. zidovudine vs. tenofovir ) .
-METHODS	We present secondary analyses of mtDNA haplogroups and ENFD changes .
-METHODS	ENFD , peripheral blood mononuclear cell mitochondrial complex I and IV , and 8-oxo-deoxyguanine ( 8-oxo-dG ) were quantified .
-METHODS	Peripheral blood mononuclear cell mtDNA sequences were obtained for haplogroup determination .
-METHODS	Multivariate regression of ENFD change was performed .
-RESULTS	Paired ENFD was available from 118 patients .
-RESULTS	Median age , CD4 cell count , and height at entry were 34 years , 172 cells/l , and 162 cm , respectively .
-RESULTS	Major haplogroups included M ( 42 % ) , F ( 21 % ) , and B ( 16 % ) .
-RESULTS	Baseline ENFD , CD4 cell count , randomized ART , and biomarkers did not differ by haplogroup .
-RESULTS	Haplogroup B patients were older ( P = 0.02 ) at baseline , and had an increase in median ENFD ( +1.5 vs. -2.9 fibers/mm ; P = 0.03 ) and 8-oxo-dG break frequency ( +0.05 vs. 0.00 ; P = 0.05 ) compared to other haplogroups .
-RESULTS	In a multivariate model , haplogroup B was associated with increased ENFD ( = 3.5 , P = 0.009 ) at week 24 , whereas older age ( P = 0.02 ) , higher baseline CD4 cell count , ( P = 0.03 ) , higher complex I level ( P = 0.03 ) , and higher ENFD ( P < 0.001 ) at baseline were all associated with decreased ENFD .
-RESULTS	Three of the six HIV-SN cases were haplogroup B ( P = 0.05 ) .
-CONCLUSIONS	Thai persons belonging to mtDNA haplogroup B had increased ENFD and 8-oxo-dG on ART , and were more likely to develop HIV-SN .
-CONCLUSIONS	These results suggest that mtDNA variation influences early oxidative damage and ENFD changes .
-
-###25794212
-BACKGROUND	Chronic post-surgical pain ( CPSP ) is a not uncommon complication after mastectomy , with a reported incidence between 20 % and 68 % .
-BACKGROUND	Careful dissection , the use of minimally invasive surgical techniques , and attempts to reduce the associated inflammatory and hyperalgesic responses are suggested methods to prevent CPSP .
-OBJECTIVE	To determine if the use of perioperative lidocaine infusion is associated with decreased incidence of CPSP after mastectomy .
-METHODS	Double-blind , placebo-controlled randomized trial .
-METHODS	This is a secondary analysis of data from 61 out of 71 patients who underwent mastectomy for breast cancer .
-METHODS	Patients were randomized to either placebo ( Group P ; n = 27 ) or intravenous lidocaine ( Group L ; n = 34 , bolus 1.5 mg/kg at induction , then infusion at 2 mg/kg/hr , up to 2 hours after the end of surgery ) in a prospective double-blind design .
-METHODS	CPSP was assessed at 6 months after surgery .
-METHODS	Stepwise logistic regression analysis was performed to assess the efficacy of lidocaine .
-RESULTS	Overall 12 ( 20 % ) patients developed CPSP , 8 ( 30 % ) in the placebo group and 4 ( 12 % ) in the lidocaine group .
-RESULTS	Predictive factors for CPSP that remained significant after multivariate analysis included lidocaine ( associated with a 20-fold decrease in CPSP , P = 0.013 ) , breast implant placement ( associated with a 16-fold increase in CPSP , P = 0.034 ) , and radiotherapy ( associated with a 29-fold increase in CPSP , P = 0.008 ) .
-CONCLUSIONS	Small sample size .
-CONCLUSIONS	Perioperative lidocaine administration was associated with a decreased incidence of CPSP , while breast implant placement and radiotherapy were associated with an increased incidence .
-CONCLUSIONS	These findings suggest a protective effect of lidocaine on CPSP development in mastectomy patients .
-
-###24239386
-OBJECTIVE	To compare quality of survival in `` standard-risk '' medulloblastoma after hyperfractionated radiation therapy of the central nervous system with that after standard radiation therapy , combined with a chemotherapy regimen common to both treatment arms , in the PNET4 randomised controlled trial .
-METHODS	Participants in the PNET4 trial and their parents/caregivers in 7 participating anonymized countries completed standardized questionnaires in their own language on executive function , health status , behavior , health-related quality of life , and medical , educational , employment , and social information .
-METHODS	Pre - and postoperative neurologic status and serial heights and weights were also recorded .
-RESULTS	Data were provided by 151 of 244 eligible survivors ( 62 % ) at a median age at assessment of 15.2 years and median interval from diagnosis of 5.8 years .
-RESULTS	Compared with standard radiation therapy , hyperfractionated radiation therapy was associated with lower ( ie , better ) z-scores for executive function in all participants ( mean intergroup difference 0.48 SDs , 95 % confidence interval 0.16-0 .81 , P = .004 ) , but health status , behavioral difficulties , and health-related quality of life z-scores were similar in the 2 treatment arms .
-RESULTS	Data on hearing impairment were equivocal .
-RESULTS	Hyperfractionated radiation therapy was also associated with greater decrement in height z-scores ( mean intergroup difference 0.43 SDs , 95 % confidence interval 0.10-0 .76 , P = .011 ) .
-CONCLUSIONS	Hyperfractionated radiation therapy was associated with better executive function and worse growth but without accompanying change in health status , behavior , or quality of life .
-
-###25611079
-OBJECTIVE	The aim of this study was to identify gender specific physical activity correlates in Danish preschool children , using a socioecological approach .
-METHODS	This was a cross-sectional study conducted in Odense , Denmark .
-METHODS	The gender specific models were based on data from 174 boys and 177 girls , 5-6 years of age and enrolled in 40 randomly selected preschools .
-METHODS	Percentage of total daily time spent in moderate and vigorously physical activity ( MVPA ) was measured using ActiGraph accelerometers over 5 preschool days and 2 days off .
-METHODS	Thirty-nine potential correlates of child MVPA across 5 domains were tested for associations with gender specific MVPA .
-RESULTS	The gender specific models consistently identified motor coordination and the parents ' perceptions of their child 's activity preferences during free play to be positively associated with MVPA .
-RESULTS	Days with rain or no preschool attendance were negatively associated with MVPA .
-RESULTS	For boys , rural area and the size of the preschool playground were positively associated with MVPA , whereas for girls , it was the age and the relative preschool indoor area .
-CONCLUSIONS	Individual and overall environmental correlates of MVPA were identified .
-CONCLUSIONS	However , most correlates were not or only weakly related to MVPA .
-CONCLUSIONS	It is possible that the interaction with peers and surrounding adults might contribute the most to preschool child MVPA .
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-###24767004
-BACKGROUND	Based on findings that major depressive disorder ( MDD ) is associated to decreased dorsolateral prefrontal cortical ( DLPFC ) activity ; interventions that increase DLPFC activity might theoretically present antidepressant effects .
-BACKGROUND	Two of them are cognitive control therapy ( CCT ) , a neurocognitive intervention that uses computer-based working memory exercises , and transcranial direct current stimulation ( tDCS ) , which delivers weak , electric direct currents over the scalp .
-METHODS	We investigated whether tDCS enhanced the effects of CCT in a double-blind trial , in which participants were randomized to sham tDCS and CCT ( n = 17 ) vs. active tDCS and CCT ( n = 20 ) .
-METHODS	CCT and tDCS were applied for 10 consecutive workdays .
-METHODS	Clinicaltrials.gov identifier : NCT01434836 .
-RESULTS	Both CCT alone and combined with tDCS ameliorated depressive symptoms after the acute treatment period and at follow-up , with a response rate of approximately 25 % .
-RESULTS	Older patients and those who presented better performance in the task throughout the trial ( possibly indicating greater engagement and activation of the DLPFC ) had greater depression improvement in the combined treatment group .
-CONCLUSIONS	Our exploratory findings should be further confirmed in prospective controlled trials .
-CONCLUSIONS	CCT and tDCS combined might be beneficial for older depressed patients , particularly for those who have cognitive resources to adequately learn and improve task performance over time .
-CONCLUSIONS	This combined therapy might be specifically relevant in this subgroup that is more prone to present cognitive decline and prefrontal cortical atrophy .
-
-###25305572
-OBJECTIVE	To evaluate if the use of Valleylab mode ( `` V mode '' ) ( Covidien , Mansfield , MA ) electrothermal energy for colpotomy during total laparoscopic hysterectomy ( LH ) results in a smaller margin of thermal injury to the upper vagina compared with traditional cut/coagulate ( cut/coag ) electrothermal energy .
-METHODS	Prospective randomized clinical trial ( Canadian Task Force classification I ) .
-METHODS	University medical center .
-METHODS	A total of 101 subjects who underwent LH between June 2010 and August2012 .
-METHODS	Subjects were randomized to colpotomy by V mode electrothermal energy or cut/coag electrothermal energy .
-RESULTS	The primary end point was the median depth of thermal injury measured in millimeters .
-RESULTS	The secondary end points included the proportion of subjects who developed granulation tissue , induration , infection , or dehiscence at the vaginal cuff at 4weeks , 3months , or 6months postoperatively .
-RESULTS	There was no significant difference in the median depth of thermal injury in the cut/coag and V mode arms ( anterior margin : 0.68 mm vs 0.63 mm [ p = .94 ] , posterior margin : 0.66 mm vs 0.70 mm [ p = .87 ] , respectively ) .
-RESULTS	Twenty-seven percent of subjects in each arm developed at least 1 of the clinical end points at 4weeks , 3months , or 6months postoperatively ( granulation tissue : 6 % -18 % vs 8 % -21 % , induration : 0 % -2 % vs 4 % -5 % , infection : 0 % -4 % vs 0 % -10 % , dehiscence : 2 % vs 0 % in the cut/coag and V mode arms , respectively ) , with no difference between arms ( p = 1.0 ) .
-CONCLUSIONS	The V mode does not reduce the depth of thermal injury compared with cut/coag electrothermal energy when used for colpotomy incision during total laparoscopic hysterectomy ( Clinical Trials.gov ID : NCT02080546 ) .
-
-###24722839
-OBJECTIVE	To evaluate the antimicrobial activity of a new , transparent composite film dressing , whose adhesive contains chlorhexidine gluconate ( CHG ) , against the native microflora present on human skin .
-METHODS	CHG-containing adhesive film dressings and non-antimicrobial control film dressings were applied to the skin on the backs of healthy human volunteers without antiseptic preparation .
-METHODS	Dressings were removed 1 , 4 or 7 days after application .
-METHODS	The bacterial populations underneath were measured by quantitative cultures ( cylinder-scrub technique ) and compared with one another as a function of time .
-RESULTS	The mean baseline microflora recovery was 3.24 log10 cfu/cm ( 2 ) .
-RESULTS	The mean log reductions from baseline measured from underneath the CHG-containing dressings were 0.87 , 0.78 and 1.30 log10 cfu/cm ( 2 ) on days 1 , 4 and 7 , respectively , compared with log reductions of 0.67 , -0.87 and -1.29 log10 cfu/cm ( 2 ) from underneath the control film dressings .
-RESULTS	There was no significant difference between the log reductions of the two treatments on day 1 , but on days 4 and 7 the log reduction associated with the CHG adhesive was significantly higher than that associated with the control adhesive .
-CONCLUSIONS	The adhesive containing CHG was associated with a sustained antimicrobial effect that was not present in the control .
-CONCLUSIONS	Incorporating the antimicrobial into the adhesive layer confers upon it bactericidal properties in marked contrast to the non-antimicrobial adhesive , which contributed to bacterial proliferation when the wear time was 4 days .
-
-###26299216
-BACKGROUND	Third-generation coronary drug-eluting stents ( DES ) with biodegradable polymers have been designed to improve safety and efficacy .
-BACKGROUND	We designed a large scale registry-based randomized clinical trial to compare 2 third-generation DES : a thin strut , cobalt-chromium DES with silicon carbide-coating releasing sirolimus from a biodegradable polymer ( O-SES , Orsiro ; Biotronik , Blach , Switzerland ) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents ( N-BES , Nobori ; Terumo , Tokyo , Japan ) in an all-comer patient population .
-METHODS	The multicenter SORT OUT VII trial ( NCT01879358 ) randomly assigned 2,530 patients to treatment with biodegradable polymer O-SES or biodegradable polymer N-BES at 3 sites in Western Denmark .
-METHODS	Patients were eligible , if they were 18 years old ; had chronic stable coronary artery disease or acute coronary syndromes ; and 1 coronary lesion with > 50 % diameter stenosis , requiring treatment with a DES .
-METHODS	The primary end point target lesion failure is a composite of cardiac death , myocardial infarction ( not related to other than index lesion ) , or target lesion revascularization within 12 months .
-METHODS	Clinically , driven event detection based on Danish registries will be used .
-METHODS	An event rate of 6.5 % is assumed in each stent group .
-METHODS	With a sample size of 1,157 patients in each treatment arm , a 2-group large-sample normal approximation test of proportions with a 1-sided 5 % significance level will have 90 % power to detect noninferiority of the O-SES compared with the N-BES with a predetermined noninferiority margin of 3.0 % .
-CONCLUSIONS	The SORT OUT VII trial will determine whether the biodegradable polymers O-SES is noninferior to the N-BES with respect to driven event .
-
-###25795410
-BACKGROUND	Nivolumab , a fully human IgG4 PD-1 immune checkpoint inhibitor antibody , can result in durable responses in patients with melanoma who have progressed after ipilimumab and BRAF inhibitors .
-BACKGROUND	We assessed the efficacy and safety of nivolumab compared with investigator 's choice of chemotherapy ( ICC ) as a second-line or later-line treatment in patients with advanced melanoma .
-METHODS	In this randomised , controlled , open-label , phase 3 trial , we recruited patients at 90 sites in 14 countries .
-METHODS	Eligible patients were 18 years or older , had unresectable or metastatic melanoma , and progressed after ipilimumab , or ipilimumab and a BRAF inhibitor if they were BRAF ( V 600 ) mutation-positive .
-METHODS	Participating investigators randomly assigned ( with an interactive voice response system ) patients 2:1 to receive an intravenous infusion of nivolumab 3 mg/kg every 2 weeks or ICC ( dacarbazine 1000 mg/m ( 2 ) every 3 weeks or paclitaxel 175 mg/m ( 2 ) combined with carboplatin area under the curve 6 every 3 weeks ) until progression or unacceptable toxic effects .
-METHODS	We stratified randomisation by BRAF mutation status , tumour expression of PD-L1 , and previous best overall response to ipilimumab .
-METHODS	We used permuted blocks ( block size of six ) within each stratum .
-METHODS	Primary endpoints were the proportion of patients who had an objective response and overall survival .
-METHODS	Treatment was given open-label , but those doing tumour assessments were masked to treatment assignment .
-METHODS	We assessed objective responses per-protocol after 120 patients had been treated with nivolumab and had a minimum follow-up of 24 weeks , and safety in all patients who had had at least one dose of treatment .
-METHODS	The trial is closed and this is the first interim analysis , reporting the objective response primary endpoint .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01721746 .
-RESULTS	Between Dec 21 , 2012 , and Jan 10 , 2014 , we screened 631 patients , randomly allocating 272 patients to nivolumab and 133 to ICC .
-RESULTS	Confirmed objective responses were reported in 38 ( 317 % , 95 % CI 235-408 ) of the first 120 patients in the nivolumab group versus five ( 106 % , 35-231 ) of 47 patients in the ICC group .
-RESULTS	Grade 3-4 adverse events related to nivolumab included increased lipase ( three [ 1 % ] of 268 patients ) , increased alanine aminotransferase , anaemia , and fatigue ( two [ 1 % ] each ) ; for ICC , these included neutropenia ( 14 [ 14 % ] of 102 ) , thrombocytopenia ( six [ 6 % ] ) , and anaemia ( five [ 5 % ] ) .
-RESULTS	We noted grade 3-4 drug-related serious adverse events in 12 ( 5 % ) nivolumab-treated patients and nine ( 9 % ) patients in the ICC group .
-RESULTS	No treatment-related deaths occurred .
-CONCLUSIONS	Nivolumab led to a greater proportion of patients achieving an objective response and fewer toxic effects than with alternative available chemotherapy regimens for patients with advanced melanoma that has progressed after ipilimumab or ipilimumab and a BRAF inhibitor .
-CONCLUSIONS	Nivolumab represents a new treatment option with clinically meaningful durable objective responses in a population of high unmet need .
-BACKGROUND	Bristol-Myers Squibb .
-
-###25641591
-OBJECTIVE	To investigate the effect of stretch-and-flow voice therapy on vocal function and handicap .
-METHODS	Randomized controlled trial .
-METHODS	Participants with primary muscle tension dysphonia were randomly assigned to experimental or control groups .
-METHODS	Experimental participants received vocal hygiene education followed by 6 weeks of stretch-and-flow voice therapy .
-METHODS	Control participants received vocal hygiene education only .
-METHODS	Outcome variables consisted of a measure of vocal handicap ( Voice Handicap Index [ VHI ] ) , maximum phonation time , s/z ratio , and acoustic measures .
-METHODS	All measures were obtained at baseline prior to treatment and within 2 weeks posttreatment or at the end of the control period .
-METHODS	The pre - to posttreatment measurement change ( delta ) was applied to statistical analyses .
-RESULTS	A multivariate analysis of variance revealed significant group differences in pre-to-post changes on measures of VHI , maximum phonation time , and cepstral peak prominence ( CPP ) in connected speech and vowels ( P = 0.003 , 0.013 , 0.025 , and 0.017 respectively ) , with a significant reduction of VHI ( Cohen 's d = 1.6 ) , increase in maximum phonation time ( Cohen 's d = 1.2 ) , increase of CPP in connected speech ( Cohen 's d = 1.2 ) , and increase of CPP in vowels ( Cohen 's d = 1.1 ) in the experimental group compared to the control group .
-CONCLUSIONS	This preliminary small sample randomized controlled trial found significantly greater improvement in vocal handicap , maximum phonation time , and acoustic measures of vocal function after participants received stretch-and-flow voice therapy compared to participants receiving vocal hygiene education alone .
-CONCLUSIONS	Additional research incorporating larger samples will be needed to confirm and further investigate these findings .
-METHODS	1b .
-
-###25739769
-OBJECTIVE	To examine the impact of providing rapid diagnostic tests for malaria on fever management in private drug retail shops where most poor rural people with fever present , with the aim of reducing current massive overdiagnosis and overtreatment of malaria .
-METHODS	Cluster randomized trial of 24 clusters of shops .
-METHODS	Dangme West , a poor rural district of Ghana .
-METHODS	Shops and their clients , both adults and children .
-METHODS	Providing rapid diagnostic tests with realistic training .
-METHODS	The primary outcome was the proportion of clients testing negative for malaria by a double-read research blood slide who received an artemisinin combination therapy or other antimalarial .
-METHODS	Secondary outcomes were use of antibiotics and antipyretics , and safety .
-RESULTS	Of 4603 clients , 3424 ( 74.4 % ) tested negative by double-read research slides .
-RESULTS	The proportion of slide-negative clients who received any antimalarial was 590/1854 ( 32 % ) in the intervention arm and 1378/1570 ( 88 % ) in the control arm ( adjusted risk ratio 0.41 ( 95 % CI 0.29 to 0.58 ) , P < 0.0001 ) .
-RESULTS	Treatment was in high agreement with rapid diagnostic test result .
-RESULTS	Of those who were slide-positive , 690/787 ( 87.8 % ) in the intervention arm and 347/392 ( 88.5 % ) in the control arm received an artemisinin combination therapy ( adjusted risk ratio 0.96 ( 0.84 to 1.09 ) ) .
-RESULTS	There was no evidence of antibiotics being substituted for antimalarials .
-RESULTS	Overall , 1954/2641 ( 74 % ) clients in the intervention arm and 539/1962 ( 27 % ) in the control arm received appropriate treatment ( adjusted risk ratio 2.39 ( 1.69 to 3.39 ) , P < 0.0001 ) .
-RESULTS	No safety concerns were identified .
-CONCLUSIONS	Most patients with fever in Africa present to the private sector .
-CONCLUSIONS	In this trial , providing rapid diagnostic tests for malaria in the private drug retail sector significantly reduced dispensing of antimalarials to patients without malaria , did not reduce prescribing of antimalarials to true malaria cases , and appeared safe .
-CONCLUSIONS	Rapid diagnostic tests should be considered for the informal private drug retail sector.Registration Clinicaltrials.gov NCT01907672 .
-
-###24612304
-BACKGROUND	Stringent control of proteolytic activity represents a major therapeutic approach for wound-bed preparation .
-OBJECTIVE	We tested whether a protease-modulating polyacrylate - ( PA - ) containing hydrogel resulted in a more efficient wound-bed preparation of venous leg ulcers when compared to an amorphous hydrogel without known protease-modulating properties .
-METHODS	Patients were randomized to the polyacrylate-based hydrogel ( n = 34 ) or to an amorphous hydrogel ( n = 41 ) .
-METHODS	Wound beds were evaluated by three blinded experts using photographs taken on days 0 , 7 and 14 .
-RESULTS	After 14 days of treatment there was an absolute decrease in fibrin and necrotic tissue of 37.6 29.9 percentage points in the PA-based hydrogel group and by 16.8 23.0 percentage points in the amorphous hydrogel group .
-RESULTS	The absolute increase in the proportion of ulcer area covered by granulation tissue was 36.0 27.4 percentage points in the PA-based hydrogel group and 14.5 22.0 percentage points in the control group .
-RESULTS	The differences between the groups were significant ( decrease in fibrin and necrotic tissue P = 0.004 and increase in granulation tissue P = 0.0005 , respectively ) .
-CONCLUSIONS	In particular , long-standing wounds profited from the treatment with the PA-based hydrogel .
-CONCLUSIONS	These data suggest that PA-based hydrogel dressings can stimulate normalization of the wound environment , particularly in hard-to-heal ulcers .
-
-###25061709
-OBJECTIVE	To determine the efficacy of a multivalent modified-live virus ( MLV ) vaccine containing a Mannheimia haemolytica toxoid to reduce pneumonia and mortality rate when administered to calves challenge exposed with virulent Bibersteinia trehalosi .
-OBJECTIVE	Animals-74 Holstein calves .
-METHODS	Calves were assigned to 2 treatment groups .
-METHODS	Calves in the control group ( n = 36 ) were vaccinated by SC administration of 2 mL of a commercial 5-way MLV vaccine , and calves in the other group ( 38 ) were vaccinated by SC administration of a 2-mL dose of a 5-way MLV vaccine containing M haemolytica toxoid ( day 0 ) .
-METHODS	On day 21 , calves were transtracheally administered B trehalosi .
-METHODS	Serum was obtained for analysis of antibody titers against M haemolytica leukotoxin .
-METHODS	Nasopharyngeal swab specimens were collected from calves 1 day before vaccination ( day -1 ) and challenge exposure ( day 20 ) and cultured to detect bacterial respiratory pathogens .
-METHODS	Clinical scores , rectal temperature , and death attributable to the challenge-exposure organism were recorded for 6 days after challenge exposure .
-METHODS	Remaining calves were euthanized at the end of the study .
-METHODS	Necropsy was performed on all calves , and lung lesion scores were recorded .
-RESULTS	Calves vaccinated with the MLV vaccine containing M haemolytica toxoid had significantly lower lung lesion scores , mortality rate , and clinical scores for respiratory disease , compared with results for control calves .
-CONCLUSIONS	Administration of a multivalent MLV vaccine containing M haemolytica toxoid protected calves against challenge exposure with virulent B trehalosi by reducing the mortality rate , lung lesion scores , and clinical scores for respiratory disease .
-
-###24463668
-OBJECTIVE	To investigate phone follow-up with a semiquantitative urine pregnancy test and symptom checklist as a replacement for universal clinic follow-up after medical abortion .
-METHODS	One thousand four hundred thirty-three women seeking early medical abortion at four hospitals in Vietnam were randomized to clinic or phone follow-up .
-METHODS	Women allocated to clinic follow-up returned to the hospital for confirmation of abortion outcome 2 weeks after mifepristone administration .
-METHODS	Women assigned to phone follow-up completed a semiquantitative pregnancy test at initial visit to determine baseline human chorionic gonadotropin range and again at home 2 weeks later .
-METHODS	Clinic staff called women to review the pregnancy test results and symptom checklist .
-METHODS	Women who screened positive were referred to the clinic .
-METHODS	Effectiveness , feasibility , and acceptability of the follow-up methods were assessed .
-RESULTS	The rate of ongoing pregnancy was not significantly different between the two groups ( clinic : 2.7 % phone , 2.5 % , relative risk 0.9 , 95 % confidence interval 0.99-1 .02 ) .
-RESULTS	Eighty-five percent of women in the phone group did not need an additional clinic visit .
-RESULTS	Phone follow-up was highly effective in screening for ongoing pregnancy with a sensitivity and specificity of 92.8 % and 90.6 % , respectively .
-RESULTS	Specificity of the pregnancy test alone ( eg , without the symptom checklist ) was higher ( 95.7 % ) .
-CONCLUSIONS	Phone follow-up offers a feasible and effective approach to identify women with ongoing pregnancy after early medical abortion .
-CONCLUSIONS	When used with the semiquantitative pregnancy test , the symptom checklist offered no additional benefit and decreased the specificity of the screening .
-CONCLUSIONS	Given its effectiveness and ease of use , the semiquantitative pregnancy test alone could replace routine clinic follow-up after early medical abortion .
-BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01150422 .
-METHODS	I.
-
-###24774470
-BACKGROUND	Weight loss interventions often present small mean weight changes over time , despite the fact that a substantial proportion of the participants lost more weight .
-BACKGROUND	This effect is often leveled out by the substantial proportion of participants who gained weight during the trial .
-BACKGROUND	The aim of this study is to identify and describe distinct subgroups of participants with different weight change trajectories during and after a weight loss intervention .
-METHODS	We used data from a weight loss intervention that was part of a randomized controlled trial on the preventive effect of a tailor-made weight loss intervention and oral glucosamine sulfate on the incidence of knee osteoarthritis in 407 overweight women aged 50 to 60years .
-METHODS	Latent class growth analysis ( LCGA ) was used to identify subgroups of participants with different weight change trajectories over time .
-RESULTS	Using LCGA , we identified three subgroups with different trajectories of weight change , one large group ( n = 298 ) with almost no change over time , and two smaller groups ( both n = 48 ) , of which one represents participants who steadily gained weight over time , whereas the other represents participants who steadily lost weight over time .
-RESULTS	Participants that had relatively low body weight around their 40th year of life and that gained weight in the year preceding the study were most likely to belong to the group that lost weight .
-CONCLUSIONS	LCGA was a suitable method to identify three distinct groups of participants with different trajectories of weight change .
-CONCLUSIONS	Low body weight at age 40 and weight gain in the year preceding the study were associated with a higher chance of membership of thegroup that lost weight .
-CONCLUSIONS	It seems weight loss that occurred during this weight loss intervention was mostly recently gained weight .
-
-###26123090
-OBJECTIVE	To analyze the clinical characteristics of a serous retinopathy associated with mitogen-activated protein kinase kinase ( MEK ) inhibition with binimetinib treatment for metastatic cutaneous melanoma ( CM ) and uveal melanoma ( UM ) , and to determine possible pathogenetic mechanisms that may lead to this retinopathy .
-METHODS	Prospective observational , cohort-based , cross-sectional study .
-METHODS	Thirty CM patients and 5 UM patients treated with the MEK inhibitor binimetinib ( CM ) or a combination of binimetinib and the protein kinase C inhibitor sotrastaurin ( UM ) .
-METHODS	Extensive ophthalmic examination was performed , including Early Treatment of Diabetic Retinopathy Study best-corrected visual acuity , applanation tonometry , slit-lamp examination , indirect ophthalmoscopy , digital color fundus photography , and optical coherence tomography ( OCT ) .
-METHODS	In selected cases , additional examinations were performed , including visual field testing and electro-oculography ( EOG ) .
-METHODS	Blood samples were obtained from 3 CM patients and 3 UM patients to analyze the presence of autoantibodies against retinal and retinal pigment epithelium ( RPE ) proteins .
-METHODS	Visual symptoms , visual acuity , fundus appearance , characteristics on OCT , fundus autofluorescence ( FAF ) , and EOG .
-RESULTS	Six CM patients ( 20 % ) and 2 UM patients ( 40 % ) reported visual symptoms during the study .
-RESULTS	The median time to the onset of symptoms , which were all mild and transient , was 3.5 days ( range , < 1 hour to 3 weeks ) .
-RESULTS	On OCT , subretinal fluid ( SRF ) was detected in 77 % of CM patients and 60 % of UM patients .
-RESULTS	In the 26 patients with SRF , the fovea was affected in 85 % .
-RESULTS	After the start of the medication , an EOG was performed in 19 eyes of 11 patients ; 16 of these eyes ( 84 % ) developed SRF on OCT. .
-RESULTS	Fifteen of these eyes ( 94 % ) showed an abnormal Arden ratio ( < 1.65 ) .
-RESULTS	A broad pattern of anti-retinal antibodies was found in 3 CM patients and 2 UM patients tested , whereas anti-RPE antibodies were detected in all 6 tested patients .
-CONCLUSIONS	A time-dependent and reversible serous retinopathy can develop both in patients with metastatic CM and UM treated with binimetinib .
-CONCLUSIONS	A minority of patients develop visual symptoms , which are generally mild and transient .
-CONCLUSIONS	A cause of binimetinib-associated serous retinopathy may be toxicity of medication , but autoantibodies also may be involved .
-
-###24556083
-OBJECTIVE	Leukocytapheresis is an extracorporeal therapy for ulcerative colitis .
-OBJECTIVE	However , no large-scale study on leukocytapheresis has been reported .
-OBJECTIVE	This large-scale , prospective , observational study aimed to evaluate the treatment outcomes of leukocytapheresis for active ulcerative colitis in clinical practice .
-METHODS	Patients with active ulcerative colitis treated with leukocytapheresis using a Cellsorba E column between May 2010 and December 2012 were enrolled from 116 medical facilities in Japan .
-RESULTS	A total of 847 patients were enrolled , and 623 were available for efficacy analysis .
-RESULTS	Out of 847 patients , 80.3 % of the patients had moderate to severe disease activity , and 67.6 % were steroid refractory .
-RESULTS	As concomitant medications , 5-aminosalicylic acids , corticosteroids , and thiopurines were administered to 94.8 % , 63.8 % , and 32.8 % of the patients , respectively .
-RESULTS	In addition , infliximab and tacrolimus were concomitantly used in 5.8 % and 12.3 % , respectively .
-RESULTS	Intensive leukocytapheresis ( 4 leukocytapheresis sessions within the first 2 weeks ) was used in > 70 % of the patients .
-RESULTS	Adverse events were seen in 10.3 % ( 87/847 ) , which were severe in only 5 patients ( 0.6 % ) .
-RESULTS	Any concomitant medications did not increase the incidence of adverse events .
-RESULTS	Intensive leukocytapheresis was as safe as the conventional weekly procedure .
-RESULTS	The overall clinical remission rate was 68.9 % ( 429/623 ) , and the mucosal healing rate was 62.5 % ( 145/232 ) .
-RESULTS	Clinical remission was achieved more frequently and rapidly in the intensive group than in the weekly group .
-CONCLUSIONS	This large-scale study indicates that leukocytapheresis , including intensive procedure , is a safe and effective therapeutic option for active ulcerative colitis .
-
-###25582611
-BACKGROUND	The anaesthetic potency of intravenous propofol is quantified by its Cp50 value , which is defined as the plasma concentration required to prevent movement response in 50 % of patients to surgical stimuli .
-BACKGROUND	We hypothesised that , in addition to propofol anaesthesia , an intravenous bolus of lidocaine 1.5 mg/kg will decrease the Cp50 value of propofol during anaesthesia .
-METHODS	We enrolled 54 elective surgical patients undergoing propofol-based anaesthesia , and randomised them to either lidocaine 1.5 mg/kg , lidocaine 0.5 mg/kg or placebo ( NaCl 0.9 % ) 3min before skin incision .
-METHODS	The propofol Cp50 value was then calculated using the ` up-and-down ' method of Dixon and Massey .
-RESULTS	There was no significant reduction in propofol requirements after the administration of 0.5 mg/kg lidocaine from 8.5 g/ml [ confidence interval ( CI ) 6.0-11 .625 ] to 8.25 g/ml ( CI 6.75-9 .76 ) ; however , a bolus of 1.5 mg/kg lidocaine decreased the Cp50 value of propofol by 42 % from 8.5 g/ml ( CI 6.0-11 .625 ) to 4.92 g/ml ( CI 4.5-5 .78 ) ( P < 0.05 ) .
-CONCLUSIONS	An intravenous bolus injection of 1.5 mg/kg lidocaine 2 % caused a significant reduction of the propofol Cp50 value .
-
-###24670273
-OBJECTIVE	The purpose of this study was to compare the success rate of monocanalicular versus that of bicanalicular silicone intubations of the nasolacrimal duct for nasolacrimal duct stenosis ( NLDS ) in adults ( patent nasolacrimal duct with resistance to positive-pressure irrigation ) .
-METHODS	In a prospective randomized clinical trial , 52 eyes of 38 patients with NLDS underwent either monocanalicular silicone intubation ( MCI ) ( n = 26 eyes ) or bicanalicular silicon intubation ( BCI ) ( n = 26 eyes ) .
-METHODS	All procedures were performed by 1 oculoplastic surgeon .
-METHODS	Tube removal was planned for 3 months postoperatively .
-METHODS	Treatment success was defined as the complete resolution of epiphora or intermittent epiphora with normal dye disappearance test at 6 months after tube removal .
-RESULTS	The surgical outcome was assessed in 25 eyes with MCI and 21 eyes with BCI .
-RESULTS	The mean ( SD ) age of treatment was 52.7 ( 18.6 ) years for MCI and 49 ( 18.8 ) years for BCI .
-RESULTS	Treatment success was achieved in 19 of 25 eyes ( 76 % ) in the MCI group compared with 16 of 21 eyes ( 76.2 % ) in the BCI group .
-RESULTS	Differences between the 2 groups proved to be not significant ( P = 0.9 ) .
-RESULTS	The only complication was peripunctal pyogenic granuloma in 2 eyes with BCI .
-CONCLUSIONS	Both MCI and BCI were successful in a similar percentage of patients with NLDS .
-CONCLUSIONS	The main advantages of the former technique were simple insertion and easy removal of the tube .
-
-###24668575
-BACKGROUND	Levobupivacaine use is progressively increased for intrathecal anesthesia in transurethral resections .
-BACKGROUND	The aim was to determine ED ( 50 ) and ED ( 95 ) of intrathecal isobaric levobupivacaine by addition of 25mcg fentanyl for patients undergoing transurethral resections .
-METHODS	A total of 100 patients undergoing transurethral resections with ASA I-III , were randomized to groups receiving intrathecal 0.5 % isobaric levobupivacaine in doses of 6 , 8 , 10 , 12 or 14mg in equal volumes with 25mcg intrathecal fentanyl addition .
-METHODS	Sensorial block level was determined by pinprick and motor block by Bromage scale .
-RESULTS	Mean onset time of sensorial block in 6mg group was significantly longer than that of sensorial block in 10mg , 12mg and 14mg groups ( p < 0.01 ) , 8mg was longer than 12mg and 14mg ( p < 0.01 ) , and 10mg onset time of sensorial block was significantly longer than 12mg and 14mg ( p < 0.01 ) .
-RESULTS	Mean onset time of T10 sensory level in 6mg group was significantly longer than mean onset time of T10 sensory level in 10mg , 12mg and 14mg ( p < 0.01 ) , the mean onset time of T10 sensory level in 8mg group was also significantly longer than that of 12mg , 14mg groups ( p < 0.01 ) .
-RESULTS	ED ( 50 ) and ED ( 95 ) of levobupivacaine coadministered with 25 mcg fentanyl were 7.32 mg and 10.88 mg , respectively .
-CONCLUSIONS	Levobupivacaine with opioid co-administration can be used in doses considerably lower than doses proposed for routine use as it is a safe drug depending on its hemodynamic effects , side effects .
-
-###24643104
-OBJECTIVE	The aim of this study was to compare the effects of epidural analgesia with infiltration analgesia in postoperative pain control for total knee arthroplasty .
-METHODS	Thirty patients ( 28 female , 2 male ; mean age : 69.375.11 years , range : 61 to 80 years ) undergoing total knee arthroplasty between May 2011 and September 2011 were randomly divided into 2 groups .
-METHODS	All patients received spinal anesthesia with bupivacaine .
-METHODS	Postoperative analgesia of 72 ml 0.9 % NaCl + 48 ml bupivacaine ( 1 ml = 5 mg , total 120 ml ) was administered throughout 24 hours to Group 1 ( n = 15 ) by epidural catheter and to Group 2 ( n = 15 ) by ON-Q infiltration pump .
-METHODS	Groups were compared based on the Bromage scores and visual analog scale ( VAS ) , blood pressure , postoperative analgesia requirement and side effects .
-RESULTS	Demographic data were similar in both groups .
-RESULTS	Rates of additional analgesia requirement at the postoperative 60th minute and 2nd hour were significantly higher in Group 2 than Group 1 ( p < 0.05 ) .
-RESULTS	Rates of nausea-vomiting at the postoperative 60th minute and 2nd hour were significantly higher in Group 1 than Group 2 ( p < 0.05 and p < 0.01 , respectively ) .
-RESULTS	Bromage scores at 60 minutes and 2 hours was significantly higher in Group 1 than in Group 2 ( p < 0.01 ) .
-RESULTS	Mean VAS scores at 60 minutes and 2 hours were significantly higher in Group 2 than Group 1 ( p < 0.05 ) .
-RESULTS	While a statistically significant difference was found between systolic arterial pressure measurements at 60 minutes ( p < 0.05 ) , there was no significant difference in diastolic arterial pressure and peak heart rate .
-CONCLUSIONS	Although the analgesic effect of local infiltration is provided later than by epidural analgesia , the same level of pain control can be achieved with initial additional analgesia .
-CONCLUSIONS	Local infiltration is superior to epidural analgesia in respect of few side effects and early mobilization .
-
-###25627184
-OBJECTIVE	To evaluate whether implantation of an aspheric intraocular lens ( IOL ) results in reduced ocular aberrations and improved contrast sensitivity after cataract surgery and , therefore , changes on frequency-doubling technology ( FDT ) testing .
-METHODS	The present prospective clinical study enrolled 25 patients with bilateral cataract ( 50 eyes ) , who randomly received either an aspheric ( Akreos AO ) or a spherical ( Akreos Fit ) IOL in one eye and the other IOL in the second eye .
-METHODS	Assessment 12 months postoperatively included photopic and mesopic contrast sensitivity testing .
-METHODS	Higher-order aberrations ( HOAs ) were computed .
-METHODS	FDT testing was divided into four areas to evaluate the variation of the values at different points .
-METHODS	The median values of the local pattern thresholds ( median area contrast sensitivity [ MACS ] ) obtained with that division were calculated .
-RESULTS	The Akreos AO group obtained statistically significantly lower values of HOAs and spherical aberration compared with the Akreos Fit group .
-RESULTS	There was a statistically significant between-group difference in contrast sensitivity under mesopic conditions at all spatial frequencies .
-RESULTS	No statistically significant differences were observed in mean deviation and pattern standard deviation .
-RESULTS	The aspheric IOL exhibited higher MACS in all areas , although a statistically significant difference was reached only in the 20-degree field area ( P = 0.043 ) .
-CONCLUSIONS	Aspheric IOLs significantly reduced spherical aberration and HOAs , improving mesopic contrast sensitivity .
-CONCLUSIONS	Although there was a trend toward slightly improved FDT in the aspheric IOL group , it was not statistically significant .
-
-###24886440
-BACKGROUND	Safety measures should be applied to reduce work-related fatal and non-fatal fall injuries .
-BACKGROUND	However , according to the labor inspectorate , more than 80 % of Dutch construction sites violate safety regulations for working from heights .
-BACKGROUND	To increase compliance with safety regulations , employers and workers have to select , implement and monitor safety measures .
-BACKGROUND	To facilitate this behavioral change , stimulating knowledge awareness and personalized feedback are frequently advocated behavior change techniques .
-BACKGROUND	For this study , two behavior change strategies have been developed in addition to the announcement of safety inspections by the labor inspectorate .
-BACKGROUND	These strategies consist of 1 ) face-to-face contacts with safety consultants and 2 ) direct mail with access to internet facilities .
-BACKGROUND	The objective of this study is to evaluate the effectiveness of these two strategies on the safety violations for working from heights , the process and the cost measures .
-METHODS	This study is a block randomized intervention trial in 27 cities to establish the effects of the face-to-face guidance strategy ( N = 9 ) , a direct mailing strategy ( N = 9 ) and a control condition of no guidance ( N = 9 ) on safety violations to record by labor inspectors after three months .
-METHODS	A process evaluation for both strategies will be performed to determine program implementation ( reach , dose delivered and dose received ) , satisfaction , knowledge and perceived safety behavior .
-METHODS	A cost analysis will be performed to establish the financial costs for both strategies .
-METHODS	The present study is in accordance with the CONSORT statement .
-CONCLUSIONS	This study increases insight into performing practice-based randomized controlled trials .
-CONCLUSIONS	The outcome will help to evaluate the effect of two guidance strategies on safety violations .
-CONCLUSIONS	If these strategies are effective , implementation of these strategies through the national institute of safety and health or labor inspectorate can take place to guide construction companies in complying with safety regulations .
-BACKGROUND	NTR 4298 on 29-nov-2013 .
-
-###25442234
-BACKGROUND	Understanding mechanisms linking neighborhood context to health behaviors may provide targets for increasing lifestyle intervention effectiveness .
-BACKGROUND	Although associations between home neighborhood and obesogenic behaviors have been studied , less is known about the role of worksite neighborhood .
-OBJECTIVE	To evaluate associations between worksite neighborhood context at baseline ( 2006 ) and change in obesogenic behaviors of adult employees at follow-up ( 2007-2009 ) in a worksite randomized trial to prevent weight gain .
-METHODS	Worksite property values were used as an indicator of worksite neighborhood SES ( NSES ) .
-METHODS	Worksite neighborhood built environment attributes associated with walkability were evaluated as explanatory factors in relationships among worksite NSES , diet , and physical activity behaviors of employees .
-METHODS	Behavioral data were collected at baseline ( 2005-2007 ) and follow-up ( 2007-2009 ) .
-METHODS	Multilevel linear and logistic models were constructed adjusting for covariates and accounting for clustering within worksites .
-METHODS	Product-of-coefficients methods were used to assess mediation .
-METHODS	Analyses were performed after study completion ( 2011-2012 ) .
-RESULTS	Higher worksite NSES was associated with more walking ( OR = 1.16 , 95 % CI = 1.03 , 1.30 , p = 0.01 ) .
-RESULTS	Higher density of residential units surrounding worksites was associated with more walking and eating five or more daily servings of fruits and vegetables , independent of worksite NSES .
-RESULTS	Residential density partially explained relationships among worksite NSES , fruit and vegetable consumption , and walking .
-CONCLUSIONS	Worksite neighborhood context may influence employees ' obesogenic behaviors .
-CONCLUSIONS	Furthermore , residential density around worksites could be an indicator of access to dietary and physical activity-related infrastructure in urban areas .
-CONCLUSIONS	This may be important given the popularity of worksites as venues for obesity prevention efforts .
-
-###24284971
-OBJECTIVE	To analyze the differences between biodegradable and nondegradable nasal dressings with regard to their effects on wound healing in the short and medium term and on surgical outcomes in the long term , after endoscopic sinus surgery ( ESS ) .
-METHODS	A prospective , randomized , partly blinded , controlled trial .
-METHODS	A total of 56 patients undergoing bilateral ESS for chronic rhinosinusitis with polyposis were enrolled and randomized to receive biodegradable ( Nasopore ; Stryker , Hamilton , ON , Canada ) on one side and nondegradable packing ( Merocel ; Medtronic Xomed , Minneapolis , MN ) on the opposite side .
-METHODS	Postoperative morbidities ( pain , bleeding , facial edema , nasal blockage ) related to dressings were assessed on postoperative day 6 .
-METHODS	Wound healing ( edema , crusting , secretions , synechia , granulation tissue formation , and percentage re-epithelialization ) were evaluated at 2 weeks , 1 month , 3 months , and 6 months using modified Lund-Kennedy scores .
-METHODS	Long-term assessment at 12 months was done using validated Lund-Kennedy scores .
-RESULTS	Morbidities related to nondegradable packing were significantly higher than with degradable packing ( Wilcoxon signed rank test , P < .01 ) .
-RESULTS	Pain , bleeding , nasal blockage , and facial edema were significantly less with absorbable packing .
-RESULTS	No statistically significant difference was found between sinonasal cavities packed with biodegradable or nondegradable materials with regard to healing scores and percentage of re-epithelialization at 2 weeks , 1 month , 3 months , 6 months , and surgical outcomes at 1 year ( P > .05 ) .
-RESULTS	However , healing at 6 months was correlated with the preoperative Lund-Mackay radiology and surgery scores ( Spearman 's rho correlation test , P < .05 and P < .01 , respectively ) .
-CONCLUSIONS	No significant healing or surgical outcome differences were found between biodegradable and nondegradable packing .
-CONCLUSIONS	However pain , bleeding , nasal blockage , and facial edema were lower with biodegradable packing .
-METHODS	1b .
-
-###25074396
-BACKGROUND	Even after quitting illicit drugs , tobacco abuse remains a major cause of morbidity and mortality in former injection drug users .
-BACKGROUND	An important unmet need in this population is to have effective interventions that can be used in the context of community based care .
-BACKGROUND	Contingency management , where a patient receives a monetary incentive for healthy behavior choices , and incorporation of individual counseling regarding spirometric `` lung age '' ( the age of an average healthy individual with similar spirometry ) have been shown to improve cessation rates in some populations .
-BACKGROUND	The efficacy of these interventions on improving smoking cessation rates has not been studied among current and former injection drug users .
-METHODS	In a randomized , factorial design study , we recruited 100 active smokers from an ongoing cohort study of current and former injection drug users to assess the impact of contingency management and spirometric lung age on smoking cessation .
-METHODS	The primary outcome was 6-month biologically-confirmed smoking cessation comparing contingency management , spirometric lung age or both to usual care .
-METHODS	Secondary outcomes included differences in self-reported and biologically-confirmed cessation at interim visits , number of visits attended and quit attempts , smoking rates at interim visits , and changes in Fagerstrom score and self-efficacy .
-RESULTS	Six-month biologically-confirmed smoking cessations rates were 4 % usual care , 0 % lung age , 14 % contingency management and 0 % for combined lung age and contingency management ( p = 0.13 ) .
-RESULTS	There were no differences in secondary endpoints comparing the four interventions or when pooling the lung age groups .
-RESULTS	Comparing contingency management to non-contingency management , 6-month cessation rates were not different ( 7 % vs. 2 % ; p = 0.36 ) , but total number of visits with exhaled carbon monoxide-confirmed abstinence were higher for contingency management than non-contingency management participants ( 0.38 vs. 0.06 ; p = 0.03 ) , and more contingency management participants showed reduction in their Fagerstrom score from baseline to follow-up ( 39 % vs. 18 % ; p = 0.03 ) .
-CONCLUSIONS	While lung age appeared ineffective , contingency management was associated with more short-term abstinence and lowered nicotine addiction .
-CONCLUSIONS	Contingency management may be a useful tool in development of effective tobacco cessation strategies among current and former injection drug users .
-BACKGROUND	Clinicaltrials.gov NCT01334736 ( April 12 , 2011 ) .
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-###24476082
-BACKGROUND	Obese women have poorer in vitro fertilization outcomes , but underlying mechanisms remain unclear .
-OBJECTIVE	The objectives of the study were to compare the pharmacokinetics of human chorionic gonadotropin ( hCG ) and ovarian steroid hormone production , after subcutaneous ( s.c. ) and intramuscular ( i.m. ) injection of hCG in obese and normal-weight women .
-METHODS	This was a randomized , experimental study .
-METHODS	Twenty-two women aged 18-42 years with body mass index of 18.5-24 .9 ( normal ) or 30-40 kg/m ( 2 ) ( obese ) .
-METHODS	Participants received im urinary hCG or s.c. recombinant hCG and returned for a second injection type after a 4-week washout .
-METHODS	Intramuscular injections were performed under ultrasound guidance .
-METHODS	Blood was taken 0 , 0.5 , 1 , 2 , 4 , 6 , 8 , 12 , 24 , and 36 hours after injection .
-METHODS	hCG was measured at each time point ; estradiol , progesterone , 17-hydroxyprogesterone ( 17-OHP ) , testosterone ( T ) , dehydroepiandrosterone , and SHBG were measured at 0 and 36 hours .
-RESULTS	Twenty-two women completed the study .
-RESULTS	In both normal-weight and obese women , peak serum concentration ( Cmax ) , area under the curve ( AUC ) , and average hCG concentration were higher after i.m. injection as compared with s.c. injection ( all P < .003 ) .
-RESULTS	Obese women had markedly lower Cmax , AUC , and average hCG concentration after s.c. injection as compared with normal-weight women ( P = .02 , P = .009 , and P = .008 , respectively ) .
-RESULTS	After i.m. injection , Cmax , AUC , and average concentration were similar for normal-weight and obese women ( P = .31 , P = .25 , and P = .18 , respectively ) .
-RESULTS	Thirty-six percent of obese women had muscular layers beyond the reach of a standard 1.5 inch needle .
-RESULTS	hCG caused a significant rise in 17-OHP in both obese and normal-weight women and an increase in T in obese but not normal-weight women ( all P < .04 ) .
-CONCLUSIONS	Subcutaneous injection yields lower hCG levels in obese women .
-CONCLUSIONS	Standard-length needles are insufficient to administer i.m. injections in many obese women .
-
-###24667908
-BACKGROUND	The use of 24-h ambulatory blood pressure monitoring ( ABPM ) in clinical practice and observational epidemiological studies has grown considerably in the past 25 years .
-BACKGROUND	ABPM is a very effective technique for assessing biological , environmental , and drug effects on blood pressure .
-OBJECTIVE	In order to enhance the effectiveness of ABPM for clinical and observational research studies using analytical and graphical results , developing alternative data analysis approaches using modern statistical techniques are important .
-METHODS	The linear mixed model for the analysis of longitudinal data is particularly well suited for the estimation of , inference about , and interpretation of both population ( mean ) and subject-specific trajectories for ABPM data .
-METHODS	We propose using a linear mixed model with orthonormal polynomials across time in both the fixed and random effects to analyze ABPM data .
-RESULTS	We demonstrate the proposed analysis technique using data from the Dietary Approaches to Stop Hypertension ( DASH ) study , a multicenter , randomized , parallel arm feeding study that tested the effects of dietary patterns on blood pressure .
-CONCLUSIONS	The linear mixed model is relatively easy to implement ( given the complexity of the technique ) using available software , allows for straightforward testing of multiple hypotheses , and the results can be presented to research clinicians using both graphical and tabular displays .
-CONCLUSIONS	Using orthonormal polynomials provides the ability to model the nonlinear trajectories of each subject with the same complexity as the mean model ( fixed effects ) .
-
-###25351573
-BACKGROUND	Anterior knee pain may occur after total knee arthroplasty ( TKA ) .
-BACKGROUND	Patellar resurfacing , which is considered to lower the incidence of anterior knee pain after TKA , remains controversial .
-BACKGROUND	In the present study clinical and radiological outcomes after TKA performed on patients with clinical and radiological signs of femorotibial and patellofemoral osteoarthritis ( OA ) with and without patellar resurfacing will be compared .
-METHODS	Fifty patients will be included in a randomized controlled trial .
-METHODS	Patients scheduled for TKA with clinical and radiological signs of femorotibial and patellofemoral OA will be included .
-METHODS	Arthritis of the patellofemoral joint was determined based on the preoperative Baldini and Merchant X-ray views , which is assessed by the orthopaedic surgeon who treats the patient .
-METHODS	Exclusion criteria are rheumatoid arthritis , history of patellar fracture , tuberosity transposition , high tibial osteotomy ( HTO ) , hip arthroplasty and posterior cruciate ligament insufficiency .
-METHODS	Patients will be randomized to undergo TKA either with or without patellar resurfacing .
-METHODS	Outcomes will be assessed preoperatively , at 6 weeks and at 6 , 12 , 18 and 24 months postoperatively .
-METHODS	Primary outcome measure is the patellofemoral scoring system according to Baldini .
-METHODS	Secondary outcome measures are the Knee Society clinical rating system ( KSS ) and the Knee Osteoarthritis Outcome Scale ( KOOS ) scores .
-METHODS	Conventional weight-bearing radiographs , and views according to Baldini will be used to asses component loosening , wear , and patellofemoral problems including fracture or loosening of resurfaced patellae , subluxation and wear of non-resurfaced patellae .
-CONCLUSIONS	There is no consensus regarding patellar resurfacing during primary TKA .
-CONCLUSIONS	Current prospective studies fail to determine any differences in clinical outcome among patients after TKA with or without patellar resurfacing .
-CONCLUSIONS	This randomized controlled trial has been designed to determine the effectiveness of patellar resurfacing during TKA in patients undergoing TKA who have clinical and radiological signs of tibiofemoral and patellofemoral OA , using a specific patellofemoral outcome measurement .
-BACKGROUND	Netherlands Trial Registry NTR3108 .
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-###24745701
-BACKGROUND	Symptom scoring for the assessment of allergen immunotherapy is associated with a substantial placebo effect .
-OBJECTIVE	To assess the ability of exhaled breath temperature ( EBT ) , a putative marker of airway inflammation , to evaluate objectively the efficacy of grass pollen sublingual immunotherapy in a proof-of-concept study .
-METHODS	This was a double-blinded , placebo-controlled clinical trial in 56 subjects ( mean SD 30 12 years old , 33 men ) sensitized to grass pollen .
-METHODS	The objective measurements were EBT , spirometry , and periostin and high-sensitivity C-reactive protein in blood .
-METHODS	Overall discomfort scored on a visual analog scale was used as a proxy for subjective symptoms .
-METHODS	Evaluations were performed before , during , and after the grass pollen season .
-RESULTS	Fifty-one subjects ( 25 and 26 in the active treatment and placebo groups , respectively ) were assessed before and during the pollen season .
-RESULTS	The mean pre - vs in-season increase in EBT was significantly smaller ( by 59.1 % ) in the active treatment than in the placebo group ( P = .030 ) .
-RESULTS	Of the other objective markers , only the blood periostin level increased significantly during the pollen season ( P = .047 ) , but without intergroup differences .
-RESULTS	Subjectively , the mean pre - vs in-season increase in the visual analog scale score was 32.3 % smaller in the active treatment than in the placebo group , although this difference did not reach statistical significance ( P = .116 ) .
-CONCLUSIONS	These results suggest that the efficacy of grass pollen sublingual immunotherapy can be assessed by EBT , a putative quantitative measurement of airway inflammation , which is superior in its power to discriminate between active and placebo treatment than a subjective assessment of symptoms assessed on a visual analog scale .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01785394 .
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-###25655884
-BACKGROUND	Decreased movement ability , one of the hallmarks of Parkinson disease ( PD ) , may lead to inadequate physical activity ( PA ) and excessive time spent in sedentary behaviors-2 factors associated with an elevated risk for lifestyle-related diseases , poor management of PD , and premature death .
-BACKGROUND	To identify the extent to which people with PD are physically active , a comprehensive characterization of PA in this population is needed .
-OBJECTIVE	The study objective was to describe levels and patterns of PA and sedentary behaviors in elderly people with PD .
-METHODS	This cross-sectional study involved a free-living setting and 53 men and 42 women ( mean age = 73.4 years ) with mild to moderate idiopathic PD .
-METHODS	Time spent in PA and sedentary behaviors was assessed for 1 week with accelerometers .
-RESULTS	Mean daily step counts were 4,765 ; participants spent 589 minutes in sedentary behaviors , 141 minutes in low-intensity activities , 30 minutes in moderate-intensity lifestyle activities , and 16 minutes in moderate - to vigorous-intensity ambulatory activities .
-RESULTS	No differences were found between weekdays and weekend days .
-RESULTS	Patterns were characterized by a rise in total PA in the morning , peaking between 10 am and 3 pm , and a gradual decline toward the late evening .
-RESULTS	The proportion achieving 150 minutes of moderate - to vigorous-intensity PA per week was 27 % , and 16 % achieved 7,000 or more steps per day .
-CONCLUSIONS	Nonrandomized selection of participants may limit the generalizability of the results .
-CONCLUSIONS	Physical activity levels were generally low , in terms of both total volume and intensity , with only minor variations over the course of a day or between days .
-CONCLUSIONS	These results emphasize the need to develop strategies to increase PA and reduce time spent in sedentary behaviors in elderly people with mild to moderate PD .
-
-###24880955
-BACKGROUND	Chronic pancreatitis is a chronic inflammatory disorder characterized by progressive fibrosis of pancreatic tissue .
-BACKGROUND	The principal symptom is chronic pain resulting in reduced quality of life and inability to work .
-BACKGROUND	Short-term follow-up has shown that duodenum-preserving pancreatic head resections ( DPPHRs ) are superior in outcomes to pancreaticoduodenectomy .
-BACKGROUND	Therefore , these organ-sparing procedures have gained wide acceptance .
-BACKGROUND	This trial was conducted to compare patient outcomes 16 years after treatment for chronic pancreatitis by means of the Beger or the Frey procedure .
-METHODS	Seventy-four patients suffering from chronic pancreatitis were randomly assigned to 2 treatment groups ( Beger n = 38 ) and Frey ( n = 36 ) .
-METHODS	The perioperative courses in the randomized controlled trial and the 8-year follow-up have been reported previously .
-METHODS	All participating patients were contacted with a standardized , validated questionnaire to evaluate long-term survival , quality of life , pain , and exocrine and endocrine function .
-RESULTS	No significant differences between the 2 groups in terms of quality of life , pain control , or other somatic parameters were detected after a median of 16 years postoperatively .
-RESULTS	Mortality was comparable after Beger and Frey procedures at 39 % vs 34 % , respectively , with postoperative survivals of 13.0 1.1 years and 13.3 0.9 years , respectively ( p = 0.660 ) .
-RESULTS	No statistically significant differences were found in rates of endocrine insufficiency ( Beger 87 % vs Frey 86 % ; p = 0.953 ) or exocrine insufficiency ( Beger 77 % vs Frey 83 % ; p = 0.655 ) .
-CONCLUSIONS	Duodenum-preserving resections of the pancreatic head offered good and permanent pain relief and substantially increased quality of life in chronic pancreatitis .
-CONCLUSIONS	Overall , a 16-year long-term follow-up found comparable outcomes for the Beger and Frey procedures .
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-###24400655
-OBJECTIVE	To evaluate the efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin plus metformin ( A+M ) initial combination therapy versus either as monotherapy in drug-nave T2DM patients .
-METHODS	This international , randomized , double-blind , placebo-controlled , 26-week study involved T2DM patients with hyperglycaemia ( HbA1c 7.5-10 .0 % ) following diet/exercise therapy .
-METHODS	Patients ( N = 784 ) received placebo , alogliptin ( A , 12.5 mg BID or 25mg QD ) , metformin ( M , 500 or 1000mg BID ) or A+M ( 12.5 / 500 or 12.5 / 1000mg BID ) ; placebo , A25 for secondary analyses only .
-METHODS	week26 changes from baseline in HbA1c ( primary ) , fasting plasma glucose ( FPG ) and 2-h postprandial glucose ( PPG ) ; incidences of clinical response and hyperglycaemic rescue .
-RESULTS	Week 26 mean HbA1c reductions from baseline ( 8.45 % ) were -1.22 and -1.55 % with A+M 12.5 / 500 and 12.5 / 1000 versus -0.56 , -0.65 , and -1.11 % with A12 .5 , M500 and M1000 ( p < 0.001 , A+M vs. component monotherapies ) .
-RESULTS	FPG reductions were -1.76 and -2.55 mmol/L with 12.5 / 500 and 12.5 / 1000 versus -0.54 , -0.64 and -1.78 mmol/L with A12 .5 , M500 and M1000 ( p < 0.05 , A+M vs. component monotherapies ) .
-RESULTS	Significantly more A+M - treated patients achieved HbA1c < 7 % ( 47.1-59 .5 % vs. 20.2-34 .3 % with monotherapy ) , significantly fewer required hyperglycaemic rescue ( 2.6-12 .3 % vs. 10.8-22 .9 % with monotherapy ) .
-RESULTS	A+M caused only mild/moderate hypoglycaemia ( 1.9-5 .3 % ) and weight loss ( 0.6-1 .2 kg ) .
-CONCLUSIONS	Alogliptin plus metformin initial combination therapy was well tolerated yet more efficacious in controlling glycaemia in drug-nave T2DM patients than either as monotherapy .
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-###25426786
-OBJECTIVE	To clinically and histopathologically evaluate the anti-inflammatory effect of 0.2 % hyaluronan gel alone and with mechanical therapy on gingivitis .
-OBJECTIVE	The argyrophilic nucleolar organizer region staining technique was attempted to routinely determine its diagnostic and prognostic dependability for periodontal lesions .
-METHODS	In each of the 28 gingivitis patients , the four quadrants were subjected to different treatments : scaling , scaling + topical hyaluronan gel , only topical hyaluronan gel , and topical + intrasulcular hyaluronan gel .
-METHODS	Clinical parameters were recorded at baseline , and on days 7 , 14 , and 21 .
-METHODS	Biopsies were taken from each quadrant , inflammatory infiltrates were graded , and the argyrophilic nucleolar organizer region count was measured before and after treatment .
-RESULTS	A significant reduction was seen in clinical parameters , inflammatory infiltrates , and the argyrophilic nucleolar organizer region count within the groups .
-RESULTS	The effect of topical + intrasulcular gel was equivalent to scaling ( P > 0.05 ) .
-RESULTS	Topical + intrasulcular hyaluronan gel application demonstrated a better reduction than topical hyaluronan gel alone .
-CONCLUSIONS	Hyaluronan gel is an effective topical agent for treating gingivitis , along with scaling and intrasulcular application .
-CONCLUSIONS	The argyrophilic nucleolar organizer region count can be used as a histopathological indicator in cases of non-responsive gingivitis to assess the severity of gingival inflammation .
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-###25958108
-OBJECTIVE	We aimed to assess the dyadic validity of the Decisional Conflict Scale ( DCS ) for assessing shared decision making in clinical consultations .
-OBJECTIVE	We applied dyadic criteria , which consider the patient and physician as an interactive dyad instead of as independent individuals , to identify common patient/physician measures of patient uncertainty .
-METHODS	Patients and their physicians , participating in a randomized clustered trial , completed separately an adapted version of the DCS with five subscales .
-METHODS	We performed factor analysis on the full DCS and each subscale independently .
-METHODS	We defined a measure as dyadic when measurement invariance across patients and physicians was supported .
-RESULTS	We analyzed 332 paired responses ( physicians with adults or with parents and children ) at study entry and 339 at exit .
-RESULTS	Factor analysis showed that the full DCS is not a valid dyadic measure .
-RESULTS	However , independent analysis of each subscale showed measurement invariance for values clarity , support , and effective decision ( comparative fit index range , 0.93-1 ; root mean square error of approximation range , 0-0 .07 ; and P-value > 0.05 ) .
-CONCLUSIONS	Application of our dyadic validation criterion indicated that the full DCS can not be considered a dyadic measure .
-CONCLUSIONS	However , three of its subscales , values clarity , support and effective decision , are valid dyadic measures .
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-###26232831
-BACKGROUND	Research has shown that orthodontic patients are more likely to retain information presented in an audiovisual format .
-BACKGROUND	However , there has been little research on the effectiveness of audiovisual information provided through different routes such as the Internet .
-BACKGROUND	This parallel-group randomized controlled trial assessed whether provision of audiovisual information on the YouTube ( Google , San Bruno , Calif ) Web site to orthodontic patients undergoing fixed appliance treatment results in improved patient knowledge when compared with conventional methods of information provision .
-BACKGROUND	The effects of sex and ethnicity were also investigated .
-METHODS	Participants were recruited from the Department of Orthodontics of the Eastman Dental Hospital , University College London Hospitals NHS Foundation Trust , United Kingdom .
-METHODS	The patients were 13 years of age and over , with no history of orthodontic treatment , and patient and parental ( where appropriate ) consent were obtained .
-METHODS	The participants were randomized into control ( n = 34 ) and intervention ( n = 33 ) groups using a random number table ; there was stratification based on age group , with permuted blocks of 10 patients .
-METHODS	Both groups were given routine verbal and written patient information related to fixed appliances , and the participants in the intervention group were sent 3 e-mails over 6 weeks requesting that they view a 6-minute YouTube video containing similar information but in audiovisual format .
-METHODS	Patient knowledge was measured using identical questionnaires answered on the day of recruitment ( baseline ) and again 6 to 8 weeks later .
-METHODS	The researchers were unaware of group allocations when enrolling patients and scoring questionnaires .
-RESULTS	Sixty participants ( 89.55 % ) completed the study .
-RESULTS	Those who completed the trial in the intervention group ( n = 30 ) demonstrated significantly greater improvements in knowledge than did those in the control group ( n = 30 ) , scoring , on average , almost 1 point more ( 95 % CI for the difference , 0.305-1 .602 ; P = 0.005 ) on the final questionnaire .
-RESULTS	Ethnicity had a statistically significant effect on improvement in knowledge , but sex did not .
-RESULTS	No harm to any patient was noted during the trial .
-CONCLUSIONS	Presenting audiovisual information through the YouTube Web site to orthodontic patients resulted in a significant improvement in patient knowledge .
-CONCLUSIONS	Supplementation of verbal and written patient information with audiovisual information via the Internet is therefore worthy of consideration .
-BACKGROUND	National Research and Ethics Service ( REC number 12/LO/0863 ) , United Kingdom .
-METHODS	The protocol was not published before trial commencement .
-BACKGROUND	No funding or conflict of interest to be declared .
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-###25619521
-BACKGROUND	Gamithromycin is active in vitro against the bacterial agents most commonly associated with bronchopneumonia in older foals .
-BACKGROUND	However , the clinical efficacy and safety of this drug have not been investigated .
-OBJECTIVE	Gamithromycin is effective for the treatment of bronchopneumonia in foals .
-METHODS	One hundred and twenty-one foals on a farm endemic for infections caused by Rhodococcus equi .
-METHODS	In a controlled , randomized , and double blinded clinical trial , foals with ultrasonographic evidence of pulmonary abscesses ( abscess score 8.0-20 cm ) were randomly allocated in 3 treatment groups : ( 1 ) gamithromycin IM q7 days ( n = 40 ) ; ( 2 ) azithromycin with rifampin , PO q24h ( n = 40 ) ; or ( 3 ) no antimicrobial treatment ( controls ; n = 41 ) .
-METHODS	Physical examination and thoracic ultrasonography were performed by individuals unaware of treatment group assignment .
-METHODS	Foals that worsened were removed from the study .
-RESULTS	The proportion of foals that recovered without the need to be removed from the study was significantly higher for foals treated with gamithromycin ( 38 of 40 ) or azithromycin with rifampin ( 39 of 40 ) than for controls ( 32 of 41 ) .
-RESULTS	Treatment with gamithromycin or with azithromycin-rifampin resulted in a significantly faster decrease in the clinical score and abscess score compared to the controls .
-RESULTS	Adverse reactions characterized by colic ( n = 18 ) and hind limb lameness ( n = 14 ) were observed only in foals treated with gamithromycin .
-CONCLUSIONS	Gamithromycin was noninferior to azithromycin with rifampin for the treatment of bronchopneumonia in the study population but had a higher frequency of adverse reactions .
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-###25532511
-BACKGROUND	Diabetes mellitus is a rising non-communicable disease in Malaysia .
-BACKGROUND	Insulin therapy refusal is a great challenge for healthcare providers , as it results in delayed insulin initiation .
-BACKGROUND	This study was conducted to determine the prevalence of insulin therapy refusal and its associated factors .
-METHODS	This cross sectional study was conducted at seven public health clinics in Kubang Pasu district , Malaysia , from March to October 2012 .
-METHODS	A newly developed and validated questionnaire was used and participants were selected via systematic random sampling .
-METHODS	Only patients diagnosed with type II diabetes mellitus ( T2DM ) and under the public health clinic care in Kubang Pasu were included in the study .
-METHODS	Multiple logistic regressions were used to study the association between insulin therapy refusal and its associated factors .
-RESULTS	There were 461 respondents and the response rate was 100 % .
-RESULTS	Among these 461 patients with T2DM , 74.2 % refused insulin therapy .
-RESULTS	The most common reason given for refusal was a lack of confidence in insulin injection ( 85.4 % ) .
-RESULTS	Multiple logistic regression revealed that respondents who had secondary education were 55.0 % less likely to refuse insulin therapy than those who had primary or no formal education ( p = 0.009 , adjusted odds ratio [ OR ] = 0.45 , 95 % confidence interval [ CI ] = 0.25-0 .82 ) .
-RESULTS	There was also a significant inverse association between glycated haemoglobin ( HbA1c ) and insulin therapy refusal ( p = 0.047 , adjusted OR = 0.87 , 95 % CI = 0.76-1 .00 ) .
-CONCLUSIONS	Insulin therapy refusal is common in Kubang Pasu .
-CONCLUSIONS	Education status and HbA1c should be taken into consideration when counselling patients on insulin therapy initiation .
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-###24633488
-OBJECTIVE	The present study evaluated the effects of creatine monohydrate ( CrM ) consumption post-exercise on body composition and muscle strength in middle to older males following a 12-week resistance training program .
-METHODS	In a double-blind , randomized trial , 20 males aged between 55 and 70 years were randomly assigned to consume either CrM-carbohydrate ( CHO ) [ 20 g days ( -1 ) CrM + 5 g days ( -1 ) CHO 7 days , then 0.1 g kg ( -1 ) CrM + 5 g CHO on training days ( average dosage of ~ 8.8 g ) ] or placebo CHO ( 20 g days ( -1 ) CHO 7 days , then 5 g CHO on training days ) while participating in a high intensity resistance training program [ 3 sets 10 repetitions at 75 % of 1 repetition maximum ( 1RM ) ] , 3 days weeks ( -1 ) for 12 weeks .
-METHODS	Following the initial 7-day `` loading '' phase , participants were instructed to ingest their supplement within 60 min post-exercise .
-METHODS	Body composition and muscle strength measurements , blood collection and vastus lateralis muscle biopsy were completed at 0 , 4 , 8 and 12 weeks of the supplement and resistance training program .
-RESULTS	A significant time effect was observed for 1RM bench press ( p = 0.016 ) , leg press ( p = 0.012 ) , body mass ( p = 0.03 ) , fat-free mass ( p = 0.005 ) and total myofibrillar protein ( p = 0.005 ) .
-RESULTS	A trend for larger muscle fiber cross-sectional area in the type II fibers compared to type I fibers was observed following the 12-week resistance training ( p = 0.08 ) .
-RESULTS	No supplement interaction effects were observed .
-CONCLUSIONS	Post-exercise ingestion of creatine monohydrate does not provide greater enhancement of body composition and muscle strength compared to resistance training alone in middle to older males .
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-###24360928
-OBJECTIVE	The purpose of routine alcohol screening is to identify patients who may benefit from brief intervention , but patients who also have alcohol and other substance use disorders ( AUD/SUD ) likely require more intensive interventions .
-OBJECTIVE	This study sought to determine the prevalence of clinically documented AUD/SUD among VA outpatients with unhealthy alcohol use identified by routine screening .
-METHODS	VA patients 18-90 years who screened positive for unhealthy alcohol use ( AUDIT-C 3 women ; 4 men ) and were randomly selected for quality improvement standardized medical record review ( 6/06 -6 / 10 ) were included .
-METHODS	Gender-stratified prevalences of clinically documented AUD/SUD ( diagnosis of AUD , SUD , or alcohol-specific medical conditions , or VA specialty addictions treatment on the date of or 365 days prior to screening ) were estimated and compared across AUDIT-C risk groups , and then repeated across groups further stratified by age .
-RESULTS	Among 63,397 eligible patients with unhealthy alcohol use , 25 % ( n = 2109 ) women and 28 % ( n = 15,199 ) men had documented AUD/SUD ( p < 0.001 ) .
-RESULTS	The prevalence of AUD/SUD increased with increasing AUDIT-C risk , ranging from 13 % ( 95 % CI 13-14 % ) to 82 % ( 79-85 % ) for women and 12 % ( 11-12 % ) to 69 % ( 68-71 % ) for men in the lowest and highest AUDIT-C risk groups , respectively .
-RESULTS	Patterns were similar across age groups .
-CONCLUSIONS	One-quarter of all patients with unhealthy alcohol use , and a majority of those with the highest alcohol screening scores , had clinically recognized AUD/SUD .
-CONCLUSIONS	Healthcare systems implementing evidence-based alcohol-related care should be prepared to offer more intensive interventions and/or effective pharmacotherapies for these patients .
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-###25139550
-BACKGROUND	Iniparib is a novel anticancer agent initially considered a poly ( ADP-ribose ) polymerase ( PARP ) inhibitor , but subsequently shown to act via non-selective protein modification through cysteine adducts .
-BACKGROUND	This randomized phase II study investigated the addition of iniparib to gemcitabine-cisplatin in metastatic non-small-cell lung cancer ( NSCLC ) patients .
-METHODS	Patients with histologically confirmed stage IV NSCLC were randomized 2 : 1 to receive gemcitabine ( 1250 mg/m ( 2 ) , days 1/8 ) and cisplatin ( 75 mg/m ( 2 ) , day 1 ) with [ gemcitabine/cisplatin/iniparib ( GCI ) ] or without [ gemcitabine/cisplatin ( GC ) ] iniparib ( 5.6 mg/kg , days 1/4/8 / 11 ) every 3 weeks for six cycles .
-METHODS	The primary end point was the overall response rate ( ORR ) .
-METHODS	Secondary objectives included progression-free survival ( PFS ) , overall survival ( OS ) , and safety .
-METHODS	The study was not designed for formal efficacy comparison , the control arm being to benchmark results against the literature .
-RESULTS	One hundred and nineteen patients were randomized ( 39 GC and 80 GCI ) .
-RESULTS	More GCI patients were male ( 80 % GCI and 67 % GC ) and had PS 0 ( 61 % GCI and 49 % GC ) .
-RESULTS	The ORR was 25.6 % [ 95 % confidence interval ( CI ) 13.0 % -42.1 % ] with GC versus 20.0 % ( 95 % CI 11.9 % -30.4 % ) with GCI , which did not allow rejection of the null hypothesis ( ORR with GCI 20 % ; P = 0.545 ) .
-RESULTS	Median PFS was 4.3 ( 95 % CI 2.8-5 .6 ) months with GC and 5.7 ( 95 % CI 4.6-6 .6 ) months with GCI ( hazard ratio 0.89 , 95 % CI 0.56-1 .40 ) .
-RESULTS	Median OS was 8.5 ( 95 % CI 5.5 to not reached ) months with GC , and 12.0 ( 95 % CI 8.9-17 .1 ) months with GCI ( hazard ratio 0.78 , 95 % CI 0.48-1 .27 ) .
-RESULTS	More GCI patients received second-line treatment ( 51 % GC and 68 % GCI ) .
-RESULTS	Toxicity was similar in the two arms .
-RESULTS	Grade 3-4 toxicities included asthenia ( 28 % GC and 8 % GCI ) , nausea ( 3 % GC and 14 % GCI ) , and decreased appetite ( 10 % in each ) .
-CONCLUSIONS	Addition of iniparib to GC did not improve ORR over GC alone .
-CONCLUSIONS	The GCI safety profile was comparable to GC alone .
-CONCLUSIONS	Imbalances in PS and gender distribution may have impacted study results regarding PFS and OS .
-BACKGROUND	ClinicalTrial.gov Identifier NCT01086254 .
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-###25126854
-BACKGROUND	Polysorbate 80 ( P80 ) , a nonionic detergent used to solubilize proteins , is used in both oral and injectable medications including vaccines .
-BACKGROUND	Development studies with 13-valent pneumococcal conjugate vaccine ( PCV13 ) showed that adding P80 resulted in a more robust manufacturing process .
-BACKGROUND	Before adding P80 to the formulation of PCV13 , we investigated the immunogenicity and safety of PCV13 with and without P80 .
-METHODS	Phase 3 , parallel-group , randomized , active-controlled , double-blind multicenter trial was conducted at 15 sites in Poland .
-METHODS	Healthy infants were randomized ( 1:1 ) to receive PCV13 + P80 or PCV13 without P80 given at ages 2 , 3 , 4 and 12 months concomitantly with DTaP-IPV-Hib at 2 , 3 and 4 months ; hepatitis B at 2 months and measles , mumps , and rubella at 12 months .
-METHODS	Serotype-specific antipneumococcal immune responses were evaluated using antipolysaccharide capsular immunoglobulin ( Ig ) G responses and opsonophagocytic activity ( OPA ) assay .
-METHODS	Safety data were also collected .
-RESULTS	The 2 treatment groups were demographically similar .
-RESULTS	Following the infant immunization series , anticapsular IgG antibody geometric mean concentrations and OPA geometric mean titers for each serotype were within 2-fold between the 2 groups .
-RESULTS	Formal noninferiority criteria for comparison of proportion of responders ( subjects with IgG titers 0.35 g/mL ) were met for 11 of the 13 serotypes .
-RESULTS	Overall population responses were highly similar .
-RESULTS	Anticapsular IgG responses were also within 2-fold following the toddler dose .
-RESULTS	Safety profiles were similar between the 2 groups .
-CONCLUSIONS	Addition of P80 to PCV13 did not adversely affect PCV13 immunogenicity or safety when compared with vaccine formulated without P80 .
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-###24471210
-BACKGROUND	We investigated with 1HNMR-spectroscopy the effects of habitual fatty fish intake on serum lipiprotein profiles in persons with features of metabolic syndrome .
-METHODS	The participants ( n = 105 ) were randomized into three diet intervention groups .
-METHODS	The groups were given different dietary instructions .
-RESULTS	Increased intake of fatty fish had a significant ( p < 0.05 ) increasing effect on the amount of large HDL-lipoprotein subclasses and their lipids .
-CONCLUSIONS	Frequent intake of fatty fish may have beneficial effects on HDL-metabolism beyond that assumed to be related to its serum concentrations .
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-###25680595
-OBJECTIVE	To assess , in a randomized , phase 2 trial , the efficacy and safety of chemoradiotherapy with or without induction chemotherapy ( ICT ) of S1 and oxaliplatin for esophageal cancer .
-METHODS	Patients with stage II , III , or IVA esophageal cancer were randomly allocated to either 2 cycles of ICT ( oxaliplatin 130 mg/m ( 2 ) on day 1 and S1 at 40 mg/m ( 2 ) twice daily on days 1-14 , every 3 weeks ) followed by concurrent chemoradiotherapy ( CCRT ) ( 46 Gy , 2 Gy/d with oxaliplatin 130 mg/m ( 2 ) on days 1 and 21 and S1 30 mg/m ( 2 ) twice daily , 5 days per week during radiation therapy ) and esophagectomy ( arm A ) , or the same CCRT followed by esophagectomy without ICT ( arm B ) .
-METHODS	The primary endpoint was the pathologic complete response ( pCR ) rate .
-RESULTS	A total of 97 patients were randomized ( arm A/B , 47/50 ) , 70 of whom underwent esophagectomy ( arm A/B , 34/36 ) .
-RESULTS	The intention-to-treat pCR rate was 23.4 % ( 95 % confidence interval [ CI ] 11.2-35 .6 % ) in arm A and 38 % ( 95 % CI 24.5 % to 51.5 % ) in arm B. With a median follow-up duration of 30.3 months , the 2-year progression-free survival rate was 58.4 % in arm A and 58.6 % in arm B , whereas the 2-year overall survival rate was 60.7 % and 63.7 % , respectively .
-RESULTS	Grade 3 or 4 thrombocytopenia during CCRT was more common in arm A than in arm B ( 35.4 % vs 4.1 % ) .
-RESULTS	The relative dose intensity of S1 ( 89.5 % 20.6 % vs 98.3 % 5.2 % , P = .005 ) and oxaliplatin ( 91.4 % 16.8 % vs 99.0 % 4.2 % , P = .007 ) during CCRT was lower in arm A compared with arm B. Three patients in arm A , compared with none in arm B , died within 90 days after surgery .
-CONCLUSIONS	Combination chemotherapy of S1 and oxaliplatin is an effective chemoradiotherapy regimen to treat esophageal cancer .
-CONCLUSIONS	However , we failed to show that the addition of ICT to the regimen can improve the pCR rate .
-
-###25531996
-OBJECTIVE	There is a growing interest for the use of probiotics for chronic constipation .
-OBJECTIVE	A recent randomized controlled trial ( RCT ) showed a positive effect of Lactobacillus reuteri ( L. reuteri ) on bowel movement frequency in infants with chronic constipation .
-OBJECTIVE	The aim of the present study was to evaluate the effects of L. reuteri in adult patients with functional constipation .
-METHODS	A double-blind , placebo RCT was conducted in 40 adults ( 18M/22F , 35 + / -15 years ) affected by functional constipation according to the Rome III criteria .
-METHODS	Patients were randomly assigned to receive a supplementation of L. reuteri ( DSM 17938 ) , or matching placebo for 4 weeks .
-METHODS	The increase of bowel movements/week was the primary outcome , while the improvement of stool consistency was the secondary outcome .
-RESULTS	At week 4 , the mean increase in bowel movements/week was 2.6 ( SD + / -1.14 , 95 % CI :1.6 -3.6 ) in the L. reuteri group and 1.0 ( SD + / -1.95 % CI :0.12 -1.88 ) in the placebo group ( p = 0.046 ) .
-RESULTS	At the end of the treatment , the mean bowel movements/week was 5.28 + / -1.93 in the L. reuteri group and 3.89 + / -1.79 in the placebo group .
-RESULTS	There was a not significant difference in the stool consistency between the two groups .
-CONCLUSIONS	L. reuteri is more effective than the placebo in improving bowel movement frequency in adult patients with functional constipation as previously demonstrated in children , even if it seems to have no effect on stool consistency .
-
-###24794879
-BACKGROUND	The extent of heterogeneity in response to the psychopharmacological treatment of negative symptoms is unknown .
-OBJECTIVE	To examine the extent of heterogeneity in response to the treatment of predominantly negative symptoms of schizophrenia .
-METHODS	Data were analyzed from three clinical trials that compared placebo or amisulpride for up to 60days .
-METHODS	Trial participants had predominantly negative symptoms of schizophrenia ( n = 485 ) .
-METHODS	Heterogeneity of percentage reduction on the Scale for the Assessment of Negative Symptoms ( SANS ) was examined with trajectory-group based modeling followed by descriptive statistics and the prediction of trajectory group membership with logistic regression modeling .
-METHODS	Analyses were repeated separately for the placebo and amisulpride groups .
-RESULTS	Trajectory group-based modeling identified groups of non - ( n = 297 , 61.2 % ) , gradual-moderate ( n = 135 , 27.8 % ) and rapid - ( n = 53 , 10.9 % ) responders .
-RESULTS	At baseline compared to non-responders , rapid-responders had consistently significantly ( p < .05 ) higher SANS total and subscale scores .
-RESULTS	Percent SANS improvement at endpoint was greatest for the rapid-responders group , a finding that replicated stratifying by placebo and amisulpride treatment groups .
-RESULTS	Similarly , in the total sample and stratifying by placebo and amisulpride groups , dropout was not significantly associated with trajectory group membership .
-CONCLUSIONS	Trajectories of treatment response to the psychopharmacological medication of the negative symptoms of schizophrenia demonstrate substantial heterogeneity .
-CONCLUSIONS	Approximately half of the patients included in our analysis showed little improvement , and the most severely ill at baseline responded the most .
-
-###24703486
-OBJECTIVE	Fetuin-A may mediate cross-talk between the liver and adipose tissue .
-OBJECTIVE	We studied the physiologic regulation of fetuin-A and explored its potential regulation by leptin .
-METHODS	Fetuin-A levels were measured in three interventional studies as well as in in vitro experiments .
-METHODS	Study 1 : 15 lean subjects received placebo or physiologic replacement-dose recombinant human leptin ( metreleptin ) following short term complete caloric deprivation to induce severe hypoleptinemia ; Study 2 : 7 women with relative leptin deficiency due to strenuous exercise or low weight received 3 months of metreleptin ; Study 3 : 17 women with relative leptin deficiency were randomized to receive metreleptin or placebo over 9 months .
-METHODS	In study 4 human hepatoma Hep G2 cells were treated with leptin .
-METHODS	Fetuin-A mRNA expression and secretion were measured .
-RESULTS	Complete caloric deprivation significantly decreased leptin but had no effect on fetuin-A levels .
-RESULTS	Normalizing leptin levels with metreleptin in hypoleptinemic subjects had no effect on circulating fetuin-A levels .
-RESULTS	Leptin treatment had no effect on fetuin-A mRNA expression and secretion in vitro .
-CONCLUSIONS	Circulating fetuin-A levels are not affected by short and long-term energy deprivation .
-CONCLUSIONS	Furthermore , both in vivo and in vitro experiments confirm that fetuin-A is not regulated by leptin .
-
-###24751822
-BACKGROUND	Unexplained fatigue is often left untreated or treated with antidepressants .
-BACKGROUND	This randomized , placebo-controlled , single-blinded study evaluated the efficacy and tolerability of single-dose intravenous ferric carboxymaltose ( FCM ) in iron-deficient , premenopausal women with symptomatic , unexplained fatigue .
-METHODS	Fatigued women ( Piper Fatigue Scale [ PFS ] score 5 ) with iron deficiency ( ferritin < 50 g/L and transferrin saturation < 20 % , or ferritin < 15 g/L ) and normal or borderline hemoglobin ( 115 g/L ) were enrolled in 21 sites in Austria , Germany , Sweden and Switzerland , blinded to the study drug and randomized ( computer-generated randomization sequence ) to a single FCM ( 1000 mg iron ) or saline ( placebo ) infusion .
-METHODS	Primary endpoint was the proportion of patients with reduced fatigue ( 1 point decrease in PFS score from baseline to Day 56 ) .
-RESULTS	The full analysis included 290 women ( FCM 144 , placebo 146 ) .
-RESULTS	Fatigue was reduced in 65.3 % ( FCM ) and 52.7 % ( placebo ) of patients ( OR 1.68 , 95 % CI 1.05-2 .70 ; p = 0.03 ) .
-RESULTS	A 50 % reduction of PFS score was achieved in 33.3 % FCM - vs. 16.4 % placebo-treated patients ( p < 0.001 ) .
-RESULTS	At Day 56 , all FCM-treated patients had hemoglobin levels 120 g/L ( vs. 87 % at baseline ) ; with placebo , the proportion decreased from 86 % to 81 % .
-RESULTS	Mental quality-of-life ( SF-12 ) and the cognitive function scores improved better with FCM .
-RESULTS	` Power of attention ' improved better in FCM-treated patients with ferritin < 15 g/L .
-RESULTS	Treatment-emergent adverse events ( placebo 114 , FCM 209 ; most frequently headache , nasopharyngitis , pyrexia and nausea ) were mainly mild or moderate .
-CONCLUSIONS	A single infusion of FCM improved fatigue , mental quality-of-life , cognitive function and erythropoiesis in iron-deficient women with normal or borderline hemoglobin .
-CONCLUSIONS	Although more side effects were reported compared to placebo , FCM can be an effective alternative in patients who can not tolerate or use oral iron , the common treatment of iron deficiency .
-CONCLUSIONS	Overall , the results support the hypothesis that iron deficiency can affect women 's health , and a normal iron status should be maintained independent of hemoglobin levels .
-BACKGROUND	ClinicalTrials.gov NCT01110356 .
-
-###25853611
-BACKGROUND	This study compared wireless Contralateral Routing of Signals ( CROS ) hearing aid and bone-anchored hearing device ( BAHD ) in patients with single-sided deafness .
-METHODS	Eight adults with single-sided deafness previously implanted with a BAHD were given a 2-week trial with a CROS hearing aid and tested in unaided and aided conditions .
-METHODS	Both devices were compared on head shadow effect reduction , speech perception measures in quiet and in noise , self-assessment questionnaires , and daily diaries .
-RESULTS	Both the CROS and BAHD significantly reduced the head shadow effect .
-RESULTS	QuickSIN scores were significantly better with noise presented to the poorer ear , as compared to the better ear , for the unaided condition , the BAHD , and the CROS .
-RESULTS	Scores showed no significant differences between the CROS and BAHD with noise presented to the better ear , but scores with the CROS were significantly poorer than in the unaided condition with noise presented to the poorer ear .
-RESULTS	There were no significant differences between BAHD and CROS for the ratings on the Bern Benefit in Single-Sided Deafness and Speech Spatial Qualities questionnaires .
-RESULTS	Both devices were worn an average of 10 hours per day .
-RESULTS	Four participants preferred the CROS for sound quality ; three preferred the BAHD for comfort .
-CONCLUSIONS	Comparisons of CROS and BAHD need to be re-evaluated as both technologies have evolved .
-CONCLUSIONS	In our pilot study , both devices seem comparable , with the CROS avoiding the risks of surgery , and we recommend a trial of CROS in our center for first line treatment of single-sided deafness .
-
-###25461963
-OBJECTIVE	To evaluate the outcomes of the combination of red light or intense pulsed laser ( IPL ) with 5-aminolevulinic acid ( ALA ) - mediated photodynamic therapy ( PDT ) in the treatment of photodamaged neck skin .
-METHODS	The anterior of the neck was divided into four 2 cm 2 cm sections and randomly assigned to red-light , red-light-PDT , IPL or IPL-PDT group .
-METHODS	ALA cream of 5 % was applied to PDT regions for 2h prior to light irradiation .
-METHODS	Treatment was repeated once .
-METHODS	The stratum corneum ( SC ) hydration , transepidermal water loss ( TEWL ) , L ( * ) , a ( * ) , b ( * ) values , melanin index ( MI ) , erythema index ( EI ) , skin elasticity and skin thickness were examined by a blinded investigator .
-METHODS	The function and volume of thyroid were also measured .
-RESULTS	After red-light-PDT , IPL-PDT and IPL treatment , the appearance of photoaging lesion was improved .
-RESULTS	The SC hydration , L ( * ) value , elasticity and thickness increased , whereas the TEWL and MI value decreased .
-RESULTS	These changes in red-light-PDT and IPL-PDT group were more obvious than IPL group .
-RESULTS	The a ( * ) and EI value increased in red-light-PDT group .
-RESULTS	No significant change was noticed in red-light group .
-RESULTS	Partial irradiation of the thyroid did not affect the function and volume of the thyroid .
-CONCLUSIONS	IPL-PDT and red-light-PDT showed better rejuvenation effect than IPL or red light alone on the neck skin .
-
-###24238630
-BACKGROUND	Disordered eating behavior and body dissatisfaction affect a large proportion of the Dutch population and account for severe psychological , physical and social morbidity .
-BACKGROUND	Yet , the threshold for seeking professional care is still high .
-BACKGROUND	In the Netherlands , only 7.5 % of patients with bulimia nervosa and 33 % of patients with anorexia nervosa are treated within the mental health care system .
-BACKGROUND	Easily accessible and low-threshold interventions , therefore , are needed urgently .
-BACKGROUND	The internet has great potential to offer such interventions .
-BACKGROUND	The aim of this study is to determine whether a web-based treatment program for patients with eating disorders can improve eating disorder psychopathology among female patients with bulimia nervosa , binge eating disorder and eating disorders not otherwise specified .
-METHODS	This randomized controlled trial will compare the outcomes of an experimental treatment group to a waiting list control group .
-METHODS	In the web-based treatment program , participants will communicate personally and asynchronously with their therapists exclusively via the internet .
-METHODS	The first part of the program will focus on analyzing eating attitudes and behaviors .
-METHODS	In the second part of the program participants will learn how to change their attitudes and behaviors .
-METHODS	Participants assigned to the waiting list control group will receive no-reply email messages once every two weeks during the waiting period of 15 weeks , after which they can start the program .
-METHODS	The primary outcome measure is an improvement in eating disorder psychopathology as determined by the Eating Disorder Examination Questionnaire .
-METHODS	Secondary outcomes include improvements in body image , physical and mental health , body weight , self-esteem , quality of life , and social contacts .
-METHODS	In addition , the participants ' motivation for treatment and their acceptability of the program and the therapeutic alliance will be measured .
-METHODS	The study will follow the recommendations in the CONSORT statement relating to designing and reporting on RCTs .
-CONCLUSIONS	This study protocol presents the design of a RCT for evaluating the effectiveness of a web-based treatment program using intensive therapeutic support for female patients with bulimia nervosa , binge eating disorder and eating disorders not otherwise specified .
-BACKGROUND	The protocol for this study is registered with the Netherlands Trial Registry NTR2415 .
-
-###24398757
-OBJECTIVE	To compare the anaesthetic and convulsive effects of sevoflurane/remifentanil versus propofol/remifentanil combination in electroconvulsive therapy ( ECT ) .
-METHODS	In this prospective , randomized double-blind study , patients diagnosed with treatment-resistant depression were included for ECT .
-METHODS	Prior to treatment , 1g/kg remifentanil was intravenously administered to all patients , followed by anaesthetic induction with either 0.5 mg/kg propofol or 8 % sevoflurane .
-METHODS	Following muscular paralysis with succinylcholine and hypnosis , bitemporal ECT was applied .
-METHODS	Vital signs , depth of sedation , recovery parameters , motor and electroencephalography ( EEG ) convulsion activity and postictal suppression index scores were recorded .
-RESULTS	A total of 120 sessions of ECT were administered to 12 patients .
-RESULTS	Heart rate was higher in the sevoflurane group than the propofol group .
-RESULTS	Compared with the sevoflurane group , bispectral index level was lower in the propofol group during the induction period and higher during the recovery period .
-RESULTS	Anaesthetic induction and recovery times were lower , and average motor and EEG convulsion activity was longer , in the propofol group than in the sevoflurane group .
-CONCLUSIONS	Propofol/remifentanil is more successful compared with sevoflurane/remifentanil in anaesthesia management during ECT since it provides quick induction and recovery , longer seizure activity and stable haemodynamics .
-
-###24920550
-OBJECTIVE	The objective was to determine the separate and combined effects of hypoxia and inactivity/unloading on sleep architecture during a 10-day period of confinement .
-METHODS	Ten subjects participated in three 10-day trials in random order : hypoxic ambulatory ( HAMB ) , hypoxic bedrest ( HBR ) , and normoxic bedrest ( NBR ) .
-METHODS	During the HAMB and HBR trials , subjects were confined to a hypoxic facility .
-METHODS	The hypoxia profile was : simulated altitude of 2,990 m on day 1 , 3,380 m on day 2 , and 3,881 m on day 3 .
-METHODS	In the NBR and HBR trials , subjects maintained a horizontal position throughout the confinement period .
-METHODS	During each trial , sleep polysomnography was conducted one night prior to ( baseline ; altitude of facility is 940 m ) and on the first ( NT1 , altitude 2,990 m ) and tenth ( NT10 , altitude 3,881 m ) night of the 10-day intervention .
-RESULTS	Average time in sleep stage 1 decreased from NT1 to NT10 irrespective of trial .
-RESULTS	Overall incidence and time spent in periodic breathing increased from NT1 to NT10 in both HAMB and HBR .
-RESULTS	During NT1 , both HAMB and HBR reduced slow-wave sleep and increased light sleep , whereas NBR and HBR increased the number of awakenings/night .
-RESULTS	There were fewer awakenings during HAMB than NBR .
-CONCLUSIONS	Acute exposure to both hypoxia and bedrest ( HBR ) results in greater sleep fragmentation due to more awakenings attributed to bedrest , and lighter sleep as a result of reduced slow wave sleep caused by the hypoxic environment .
-
-###25415787
-BACKGROUND	Peripheral opioid receptor targeting has been well established as a novel target in clinical pain management for acute and chronic peripheral inflammatory pain .
-BACKGROUND	The physiochemical properties of the peripheral mu-opioid receptor agonist , loperamide HCl , limit the use of the free drug as an analgesic or anti-inflammatory agent , particularly for dermal delivery across intact skin .
-OBJECTIVE	Our objective was to manufacture an effective topical formulation containing loperamide using liposomal delivery that would allow loperamide to produce analgesia and anti-inflammatory effects , by penetrating the epidermis to reach peripheral opioid receptors within the dermis of intact skin .
-METHODS	A randomized , double blind , controlled animal trial .
-METHODS	Thirty-five adult male Wistar rats ( 200 - 250 g ) were randomly divided into 5 groups : loperamide HCl-encapsulated liposomal gel , naloxone methiodide + loperamide HCl-encapsulated liposomal gel , free loperamide gel , empty liposomal gel , and 1 % diclofenac gel ( Voltaren ) .
-METHODS	Diclofenac gel was used as a positive control as it is clinically used as a topical analgesic and anti-inflammatory drug .
-METHODS	Animals received an intraplantar injection of 150 l Complete Freund 's Adjuvant ( CFA ) into the right hindpaw and experiments were performed 5 days post-CFA injection , which corresponded to the peak inflammatory response .
-METHODS	All manufactured formulations were applied topically on both hind paws twice daily , whereas Voltaren gel was applied 3 times a day in accordance with the manufacturer 's instructions .
-METHODS	The dose administered was 50 l , which equated to 0.4 mg of loperamide HCl for the loperamide HCl treatment groups ( low dose ) .
-METHODS	Naloxone methiodide ( 1 mg/kg ) was administered via intraplantar injection , 15 minutes prior to application of loperamide HCl-encapsulated liposomal gel to determine opioid receptor dependent activity .
-METHODS	An investigator blinded to the treatment administered assessed time course of the antinociceptive and anti-inflammatory effects using a paw pressure analgesiometer and plethysmometer , respectively .
-RESULTS	Application of loperamide HCl in a liposomal gel formulation exerted analgesic and anti-inflammatory effects exclusively in peripheral painful inflamed tissue .
-RESULTS	This formulation produced highly significant analgesic and anti-inflammatory effects over the 48-hour time course studied following topical administration in rats with CFA-induced inflammation of the paw .
-RESULTS	As expected , the diclofenac gel group showed significant antinociception over the duration of the study ; however , this effect was lower in comparison to the loperamide HCl liposomal gel formulation .
-RESULTS	All other control groups showed no significant antinociceptive effects .
-RESULTS	In addition , all control groups ( 1 % diclofenac gel , free loperamide gel , and empty liposomal gel ) did not demonstrate a significant change in paw volume over 48 hours .
-CONCLUSIONS	In vivo studies were performed in the well-established rodent model of acute inflammatory pain .
-CONCLUSIONS	We are currently studying this approach in chronic pain models known to have clinical activation of the peripheral immune-derived opioid response .
-CONCLUSIONS	The study demonstrates that topically applied loperamide encapsulated within liposomal systems has improved therapeutic efficacy over conventional formulations for the local treatment of acute peripheral inflammatory pain conditions where the skin has remained intact .
-CONCLUSIONS	Once in the inflamed peripheral tissue , loperamide provides analgesic and anti-inflammatory effects in a similar manner to peripheral endogenous opioids .
-CONCLUSIONS	This preparation optimises the retention of drug at the site where action is required .
-
-###25181050
-BACKGROUND	Remote ischemic preconditioning ( RIPC ) induced by transient limb ischemia confers multi-organ protection and improves exercise performance in the setting of tissue hypoxia .
-BACKGROUND	We aimed to evaluate the effect of RIPC on exercise capacity in heart failure patients .
-METHODS	We performed a randomized crossover trial of RIPC ( 45-minutes limb ischemia ) compared to sham control in heart failure patients undergoing exercise testing .
-METHODS	Patients were randomly allocated to either RIPC or sham prior to exercise , then crossed over and completed the alternate intervention with repeat testing .
-METHODS	The primary outcome was peak VO2 , RIPC versus sham .
-METHODS	A mechanistic substudy was performed using dialysate from study patient blood samples obtained after sham and RIPC .
-METHODS	This dialysate was used to test for a protective effect of RIPC in a mouse heart Langendorff model of infarction .
-METHODS	Mouse heart infarct size with RIPC or sham dialysate exposure was also compared with historical control data .
-RESULTS	Twenty patients completed the study .
-RESULTS	RIPC was not associated with improvements in peak VO2 ( 15.6 + / -4.2 vs 15.3 + / -4.6 mL/kg/min ; p = 0.53 , sham and RIPC , respectively ) .
-RESULTS	In our Langendorff sub-study , infarct size was similar between RIPC and sham dialysate groups from our study patients , but was smaller than expected compared to healthy controls ( 29.0 % , 27.9 % [ sham , RIPC ] vs 51.2 % [ controls ] .
-RESULTS	We observed less preconditioning among the subgroup of patients with increased exercise performance following RIPC ( p < 0.04 ) .
-CONCLUSIONS	In this pilot study of RIPC in heart failure patients , RIPC was not associated with improvements in exercise capacity overall .
-CONCLUSIONS	However , the degree of effect of RIPC may be inversely related to the degree of baseline preconditioning .
-CONCLUSIONS	These data provide the basis for a larger randomized trial to test the potential benefits of RIPC in patients with heart failure .
-BACKGROUND	ClinicalTrials.gov + + + + + NCT01128790 .
-
-###24810970
-BACKGROUND	The minimal clinically important difference ( MCID ) is the smallest outcome change that has clinical significance .
-BACKGROUND	Its use has not been established in the study of myasthenia gravis ( MG ) .
-METHODS	Patients from a published intravenous immunoglobulin ( IVIg ) vs. placebo study were studied .
-METHODS	One anchor-based and 3 distribution-based techniques were used to identify quantitative myasthenia gravis score ( QMGS ) , repetitive nerve stimulation ( RNS ) , and single-fiber electromyography ( SFEMG ) MCID cut-offs .
-METHODS	Patients with a change-score exceeding MCID cut-offs were compared .
-RESULTS	MCID cut-offs were below a QMGS change of 3.0 .
-RESULTS	Anchor-based and 1 SEM cut-offs showed 58.3 % vs. 30.7 % responders ( P = 0.017 ) , SD 54.2 % vs. 19.2 % responders ( P = 0.018 ) , and effect size 0.519 vs. 0.164 ( P = 0.011 ) in IVIg vs. placebo .
-RESULTS	Anchor-based ( P = 0.73 ) and effect-size ( P = 0.41 ) MCID cut-offs did not show a difference between IVIg and placebo .
-RESULTS	MCID methods did not produce meaningful RNS cut-offs .
-CONCLUSIONS	QMGS MCID values provide clinically relevant information and are recommended in MG trials .
-CONCLUSIONS	MCID analysis shows that improvement in MG patients treated with IVIg reflects clinically meaningful changes .
-
-###25148170
-OBJECTIVE	Nonalcoholic fatty liver disease is associated with hepatic inflammation .
-OBJECTIVE	An emerging technique to image inflammation is PET using the glucose tracer , ( 18 ) F-FDG .
-OBJECTIVE	The purpose of this study was to determine whether in hepatic steatosis the liver accumulates FDG in excess of FDG physiologically exchanging between blood and hepatocyte .
-METHODS	Hepatic FDG uptake , as SUV = [ voxel counts / administered activity ] body weight ) , and CT density were measured in a liver region in images obtained 60 minutes after injection of FDG in 304 patients referred for routine PET/CT .
-METHODS	Maximum SUV ( region voxel with the highest count rate , SUVmax ) and average SUV ( SUVave ) were measured .
-METHODS	Blood FDG concentration was measured as the maximum SUV over the left ventricular cavity ( SUVLV ) .
-METHODS	SUVave was adjusted for hepatic fat using a formula equating percentage fat to CT density .
-METHODS	Patients were divided in subgroups on the basis of blood glucose ( < 4 , 4 to < 5 , 5 to < 6 , 6 to < 8 , 8 to < 10 , and > 10 mmol/L ) .
-METHODS	Hepatic steatosis was defined as CT density less than 40 HU ( n = 71 ) .
-RESULTS	The percentage of hepatic fat increased exponentially with blood glucose .
-RESULTS	SUVmax / SUVLV and fat-adjusted SUVave / SUVLV but not SUVave / SUVLV correlated with blood glucose .
-RESULTS	Fat-adjusted SUVave was higher in patients with hepatic steatosis ( p < 0.001 ) by ~ 0.4 in all blood glucose groups .
-RESULTS	There was a similar difference ( ~ 0.3 ) in SUVmax ( p < 0.005 ) but no difference in SUVave .
-RESULTS	SUVmax / SUVLV and fat-adjusted SUVave / SUVLV correlated with blood glucose in patients with hepatic steatosis but not in those without .
-RESULTS	SUVave / SUVLV correlated with blood glucose in neither group .
-CONCLUSIONS	FDG uptake is increased in hepatic steatosis , probably resulting from irreversible uptake in inflammatory cells superimposed on reversible hepatocyte uptake .
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-###24472087
-BACKGROUND	Actinic keratosis ( AK ) may progress to squamous cell carcinoma .
-BACKGROUND	In the case of normal or mildly photodamaged skin , lesion-directed treatments are considered valuable options despite poor published evidence of their therapeutic activity .
-OBJECTIVE	The aim of this single-centre , open-label , prospective , nonsponsored , randomized , controlled clinical trial was to compare CO2 laser ablation with cryotherapy in the treatment of isolated AKs of the face and scalp .
-METHODS	Patients with isolated ( 4 ) AKs of the face and scalp were randomized to receive CO2 laser ablation or cryotherapy .
-METHODS	After 90days , the overall complete remission ( CR ) rates of patients and lesions were assessed and correlated with thickness grade .
-RESULTS	Two hundred patients with a total number of 543 AKs were enrolled .
-RESULTS	The CR rates of lesions after 3months were 782 % with cryotherapy and 724 % with CO2 laser ablation .
-RESULTS	Thicker lesions were significantly more responsive to cryotherapy ( P = 0034 ) .
-RESULTS	Seventy-three patients ( 716 % ) had CR of all lesions 3months after cryotherapy and 64 ( 653 % ) after laser ablation .
-RESULTS	At 12months after treatment the number of patients with CR was reduced to 53 with cryotherapy and 14 with laser ablation .
-CONCLUSIONS	The rate of patients and lesions with CR is similar after 3months , but more patients remain in stable remission for 12months after cryotherapy .
-CONCLUSIONS	Cryotherapy is more effective for thick lesions .
-CONCLUSIONS	The cosmetic outcome was good or excellent in almost all patients .
-
-###25556770
-OBJECTIVE	To investigate changes in student food selection and consumption in response to the new National School Lunch Program meal patterns during fall 2011 .
-METHODS	Eight elementary and four intermediate schools in one Houston area school district were matched on free/reduced-price meal eligibility and randomized into control or intervention conditions .
-METHODS	Both intervention and control school cafeterias served the same menu .
-METHODS	The intervention school cafeterias posted the new meal pattern daily ; students could select one fruit and two vegetable servings per reimbursable meal .
-METHODS	Control school students could only select the previous meal pattern : a total of two fruit and vegetable servings per meal .
-METHODS	Students were observed during lunch : student sex and foods selected/consumed were recorded .
-METHODS	Diet analysis software was used to calculate energy/food groups selected/consumed .
-METHODS	Cochran-Mantel-Haenszel tests examined differences in the percent of students selecting each meal component by condition , controlling for sex , grade , and school free/reduced-price meal eligibility .
-METHODS	Analysis of covariance assessed differences in amount of energy/food groups selected and consumed , and differences in percent of food groups consumed .
-RESULTS	Observations were conducted for 1,149 elementary and 427 intermediate students .
-RESULTS	Compared with students in the control schools , significantly more intervention elementary and intermediate school students selected total ( P < 0.001 , P < 0.05 ) and starchy vegetables ( P < 0.001 , P < 0.01 ) ; more intervention intermediate school students selected fruit ( P < 0.001 ) , legumes ( P < 0.05 ) , and protein foods ( P < 0.01 ) .
-RESULTS	There were significantly greater amounts of these foods selected and consumed , but no differences in the proportion of the foods consumed by condition .
-RESULTS	Fewer calories were consumed by elementary and intermediate school intervention students .
-CONCLUSIONS	More intervention students selected fruit and vegetables at lunch and consumed them compared with control condition students .
-CONCLUSIONS	Future studies with larger and more diverse student populations are warranted .
-
-###25790882
-BACKGROUND	Cigarette smoking is a well-known risk factor for development of coronary artery disease ( CAD ) .
-BACKGROUND	However , some studies have suggested a `` smoker 's paradox , '' meaning neutral or favorable outcomes in smokers who have developed CAD , especially myocardial infarction ( MI ) .
-OBJECTIVE	The study aimed to examine the association of smoking status with clinical outcomes in the randomized controlled SYNTAX ( SYNergy Between PCI With TAXUS and Cardiac Surgery ) trial at 5-year follow-up .
-METHODS	Detailed smoking history was collected at baseline , 6-month , 1-year , 3-year , and 5-year follow-up .
-METHODS	The composite endpoints included death/MI/stroke ( primary endpoint ) plus major adverse cardiac and cerebrovascular events ( MACCE ) ( combination of death/MI/stroke and target lesion revascularization ) according to patient smoking status .
-METHODS	The comparison of 5-year clinical outcomes between the groups according to smoking status was performed with Cox regression using smoking status at baseline or smoking as a time-dependent covariate .
-RESULTS	A sizeable proportion ( n = 322 , 17.9 % ) of patients had changing smoking status during 5-year follow-up .
-RESULTS	One in 5 patients with complex CAD was smoking at baseline .
-RESULTS	However , 60 % stopped after revascularization while others continued to smoke .
-RESULTS	Smokers had worse clinical outcomes due to a higher incidence of recurrent MI in both revascularization arms .
-RESULTS	Smoking was an independent predictor of the composite endpoint of death/MI/stroke ( hazard ratio [ HR ] : 1.8 ; 95 % confidence interval [ CI ] : 1.3 to 2.5 ; p = 0.001 ) and MACCE ( HR : 1.4 ; 95 % CI : 1.1 to 1.7 ; p = 0.02 ) .
-CONCLUSIONS	Smoking is associated with poor clinical outcomes after revascularization in patients with complex CAD .
-CONCLUSIONS	This places further emphasis on efforts at smoking cessation to improve revascularization benefits .
-CONCLUSIONS	( SYNTAX Study : TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries ; NCT00114972 ) .
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-###24676877
-BACKGROUND	Tasisulam sodium ( hereafter referred to as tasisulam ) is a novel , highly albumin-bound agent that demonstrated activity in a phase 2 melanoma study .
-METHODS	In this open-label phase 3 study , patients with AJCC stage IV melanoma received tasisulam ( targeting an albumin-corrected exposure of 1200-6400 h ( hour ) .
-METHODS	g/mL on day 1 ) or paclitaxel ( 80 mg/m ( 2 ) on days 1 , 8 , and 15 ) every 28 days as second-line treatment .
-RESULTS	The study was placed on clinical hold after randomization of 336 patients when a safety review indicated an imbalance of possibly drug-related deaths in the tasisulam arm .
-RESULTS	Efficacy results for tasisulam versus paclitaxel revealed a response rate of 3.0 % versus 4.8 % , a median progression-free survival of 1.94 months versus 2.14 months ( P = .048 ) , and a median overall survival of 6.77 months versus 9.36 months ( P = .121 ) .
-RESULTS	The most common drug-related grade 3 laboratory toxicities ( graded according to Common Terminology for Adverse Events [ version 3.0 ] ) were thrombocytopenia ( 18.9 % ) for patients treated with tasisulam and neutropenia/leukopenia ( 8.7 % ) among those receiving paclitaxel .
-RESULTS	There were 13 possibly related deaths reported to occur on the study , with the majority occurring during cycle 2 in the setting of grade 4 myelosuppression , all in the tasisulam arm .
-RESULTS	Investigation of the unexpectedly high rate of hematologic toxicity revealed a subset of patients with low tasisulam clearance , leading to drug accumulation and high albumin-corrected exposure in cycle 2 .
-CONCLUSIONS	Although the study was stopped early because of safety issues in the tasisulam arm , tasisulam was considered unlikely to be superior to paclitaxel , and paclitaxel activity in the second-line treatment of melanoma was much lower than expected .
-CONCLUSIONS	The toxicity imbalance was attributed to an unexpectedly low tasisulam clearance in a subset of patients , underscoring the importance of pharmacokinetic monitoring of compounds with complex dosing , even in late-phase studies .
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-###24517057
-OBJECTIVE	To study the effect of transcutaneous acupoint electrical stimulation ( TAES ) on stress who received propofol target controlled infusion ( TCI ) general anesthesia in brain surgery .
-METHODS	Totally 40 neurosurgical patients of I-II grade ( ASA grading ) in our hospital were randomly divided into the TAES group ( T group ) and the control group ( C group ) , 20 in each group .
-METHODS	All patients received intravenous anesthesia by propofol TCI .
-METHODS	The TAES intervention was adopted in those of C group .
-METHODS	Electrodes were only applied to corresponding acupoints without electric stimulation .
-METHODS	The arterial blood was withdrawn before TAES ( T0 ) , before anesthesia ( T1 ) , before cutting ( T2 ) , at 60 min after encephalic incision ( T3 ) , immediately after incisions suture ( T4 ) , at about 10 min after removing tracheal catheters ( T5 ) to detect beta-endorphin ( beta-EP ) , cortisol ( COR ) , adrenalin ( E ) , blood sugar ( Glu ) .
-METHODS	The heart rate ( HR ) and mean arterial pressure ( MAP ) were recorded .
-METHODS	The total time of surgery , anesthesia , total infusion amount , blood lost amount , and urine amount were recorded .
-RESULTS	In both groups , HR , MAP , COR , and E at T2 were lower than at T0 significantly ( P < 0.05 ) .
-RESULTS	beta-EP in group C at T2 was lower than at T0 significantly ( P < 0.05 ) .
-RESULTS	HR , MAP , COR in group C at T3 were higher than at T0 significantly ( P < 0.05 ) .
-RESULTS	HR , MAP , E , and Glu in group C at T4 and T5 were higher than at T0 significantly ( P < 0.05 ) .
-RESULTS	beta-EP in group T at T1 and T3 were higher than at T0 significantly ( P < 0.05 ) .
-RESULTS	HR , COR , E , Glu , and beta-EP in group T at T4 and T5 were higher than at T0 significantly ( P < 0.05 ) .
-RESULTS	Between groups , comparing with the time point T0 , the amplitude of variation of MAP , COR , and E at T2 in group C were significantly less ( P < 0.05 ) ; the amplitude of variation of HR , MAP , and COR at T3 in group C were less significantly , when compared with the time point T0 ( P < 0.05 ) ; the amplitude of variation of HR , MAP , COR , E , and Glu at T4 and T5 in group C were less significantly , when compared with the time point T0 ( P < 0.05 ) .
-RESULTS	When comparing the two groups , the amplitude of variation of beta-EP at time points of T1 , T3 , T4 , and T5 in group T were larger than at T0 in group C ( P < 0.05 ) .
-CONCLUSIONS	TAES could reduce stress and stabilize the internal environment when used in brain surgery with propofol TCI general anesthesia .
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-###24323615
-BACKGROUND	Although axillary surgery is still considered to be a fundamental part of the management of early breast cancer , it may no longer be necessary either as treatment or as a guide to adjuvant treatment .
-BACKGROUND	The authors conducted a single-center randomized trial ( INT09/98 ) to determine the impact of avoiding axillary surgery in patients with T1N0 breast cancer and planning chemotherapy based on biological factors of the primary tumor on long-term disease control .
-METHODS	From June 1998 to June 2003 , 565 patients aged 30 years to 65 years with T1N0 breast cancer were randomized to either quadrantectomy with ( QUAD ) or without ( QU ) axillary lymph node dissection ; a total of 517 patients finally were evaluated .
-METHODS	All patients received radiotherapy to the residual breast only .
-METHODS	Chemotherapy for patients in the QUAD treatment arm was determined based on lymph node status , estrogen receptor status , and tumor grade .
-METHODS	Chemotherapy for patients in the QU treatment arm was based on estrogen receptor status , tumor grade , and human epidermal growth factor receptor 2 and laminin receptor status .
-METHODS	Overall survival ( OS ) was the primary endpoint .
-METHODS	Disease-free survival ( DFS ) and rate and time of axillary lymph node recurrence in the QU treatment arm were the secondary endpoints .
-RESULTS	After a median follow-up of > 10 years , the estimated adjusted hazards ratio of the QUAD versus QU treatment arms for OS was 1.09 ( 95 % confidence interval , 0.59-2 .00 ; P = .783 ) and was 1.04 ( 95 % confidence interval , 0.56-1 .94 ; P = .898 ) for DFS .
-RESULTS	Of the 245 patients in the QU treatment arm , 22 ( 9.0 % ) experienced axillary lymph node recurrence .
-RESULTS	The median time to axillary lymph node recurrence from breast surgery was 30.0 months ( interquartile range , 24.2 months-73 .4 months ) .
-CONCLUSIONS	Patients with T1N0 breast cancer did not appear to benefit in terms of DFS and OS from immediate axillary lymph node dissection in the current randomized trial .
-CONCLUSIONS	The biological characteristics of the primary tumor appear adequate for guiding adjuvant treatment .
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-###25183926
-BACKGROUND	Apha-2 agonists are combined with local anesthetics to extend the duration of regional anesthesia .
-BACKGROUND	We evaluated the effect of combining dexmedetomidine with levobupivacine with respect to duration of motor and sensory block and duration of analgesia .
-METHODS	Sixty patients scheduled for elective forearm and hand surgery were divided into two equal groups in a randomized double blind fashion .
-METHODS	The patients received brachial plexus block via supraclavicular route with the help of nerve stimulator .
-METHODS	In group L ( n = 30 ) 35cc of levobupivacaine with 1ml of isotonic saline and in group LD ( n = 30 ) 35cc of levobupivacine with 1 ml of ( 100 microgram ) of dexmedetomidine was given .
-METHODS	Duration of motor and sensory block and time to first rescue analgesia were recorded .
-METHODS	Data analysis was done by SPSS version 16.0 [ SPSS Inc ILLINOIS , USA , 2008 ] .
-METHODS	Categorical variables were analyzed using Pearson `` s Chi-square test .
-METHODS	Normally distributed numerical variables were analyzed using unpaired `` t '' test .
-METHODS	Skewed numerical variables within the group were analyzed using Man-Whitney `` U '' test .
-METHODS	All tests were two tailed .
-METHODS	Statistical significance was defined as P < 0.05 .
-RESULTS	Sensory and motor block durations were longer in group LD as compared to L ( P < 0.01 ) .
-RESULTS	Duration of analgesia was significantly longer in group LD as compared to group L ( p < 0.05 ) .
-CONCLUSIONS	Dexmedetomidine added to levobupivacaine in supraclavicular brachial plexus block prolongs the duration of block and the duration of postoperative analgesia .
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-###25341813
-OBJECTIVE	To investigate the correlation between regulatory T ( Treg ) cells and postmenopausal osteoporosis and the antiosteoporotic effect of 1,25-dihydroxyvitamin D3 [ 1,25 ( OH ) D ] in relation to Treg cells .
-METHODS	Fifty female BALB/c mice were randomly divided into five groups : the basal control ( BAS ) , Sham , ovariectomy ( OVX ) , OVX + diethylstilbestrol ( OVX+DES ) , and OVX +1,25 ( OH ) D. Tibias were harvested and processed with decalcification for quantitative bone histomorphometry .
-METHODS	Femurs were stained by immunohistochemistry to detect Foxp3 protein expression .
-METHODS	Spleens were used to detect Treg and Foxp3 gene expression by flow cytometry and quantitative RT-PCR , respectively .
-RESULTS	In comparison with the Sham group , a significant decrease was found in the OVX group in such indices as trabecular bone volume/total tissue area ( BV/TV ) , trabecular number ( Tb.N ) and trabecular thickness ( Tb.Th ) .
-RESULTS	1,25 ( OH ) Dand DES partly prevented the decrease in BV/TV , Tb.N , Tb.Th in OVX mice .
-RESULTS	Treg cell number , Foxp3 mRNA expression in spleen and Foxp3 protein expression in femur significantly decreased in the OVX-treated group compared with those in the sham group .
-RESULTS	1,25 ( OH ) 2Dand DES significantly increased Treg cell number and Foxp3 expression .
-RESULTS	Treg cells and Foxp3 gene expression were related to bone histomorphometric parameters .
-CONCLUSIONS	The decrease in Treg cell numbers is relevant to the postmenopausal osteoporosis .
-CONCLUSIONS	The antiosteoporosis of 1,25 ( OH ) Dis related to regulatory T cells .
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-###25529851
-BACKGROUND	Dexmedetomidine-induced bradycardia or hypotension has recently attracted considerable attention because of potentially grave consequences , including sinus arrest and refractory cardiogenic shock .
-BACKGROUND	A route other than intravenous injection or a low dose may help minimize cardiovascular risks associated with dexmedetomidine .
-BACKGROUND	However , few studies have addressed the clinical effects of low-dose intramuscular dexmedetomidine as premedication .
-METHODS	Forty American Society of Anesthesiologists physical status I adult patients undergoing suspension laryngoscopic surgery were randomized to receive intramuscular dexmedetomidine ( 1 gkg-1 ) or midazolam ( 0.02 mgkg-1 ) 30 minutes prior to anaesthesia induction .
-METHODS	The sedative , hemodynamic , and adjuvant anaesthetic effects of both premedications were assessed .
-RESULTS	The levels of sedation ( Observer 's Assessment of Alertness/Sedation scales ) and anxiety ( visual analog score ) at pre-induction , and the times to eye-opening and extubation , were not different between the groups .
-RESULTS	The heart rate response following tracheal intubation and extubation , and mean arterial pressure responses after extubation , were attenuated in the dexmedetomidine group compared to the midazolam group .
-RESULTS	No bradycardia or hypotension was noted in any patients .
-RESULTS	Propofol target concentrations at intubation and at start and completion of surgery were decreased in the dexmedetomidine group , whereas no difference in respective remifentanil levels was detected .
-CONCLUSIONS	This study provides further evidence that dexmedetomidine premedication in low dose ( 1 gkg-1 ) by intramuscular route can induce preoperative sedation and adjuvant anaesthetic effects without clinically significant bradycardia or hypotension .
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-###25113425
-OBJECTIVE	To determine which nostril is more suitable for nasotracheal intubation in patients with normal patency of both nostrils .
-METHODS	Prospective , randomized clinical trial .
-METHODS	Operating room of a university medical center .
-METHODS	191 ASA physical status 1 and 2 patients scheduled for elective oral surgery requiring general anesthesia with nasotracheal intubation .
-METHODS	Patients were randomized to two groups to undergo nasotracheal intubation through the right nostril ( Group R ; n = 96 ) or the left nostril ( n = 95 ) .
-METHODS	Standard traditional nasotracheal intubation was performed using the Macintosh laryngoscope .
-METHODS	Tube rotation was attempted for alignment toward the glottis , and Magill forceps were then used to assist intubation , as necessary .
-METHODS	Epistaxis was inspected in the pharynx after the tube tip was passed through the nasal cavity and 15 minutes after nasotracheal intubation was completed .
-METHODS	Intubation time was the interval between when the anesthesiologist opened the patient 's mouth with the cross finger maneuver and when the tube was connected to the anesthetic circuit after nasotracheal completion .
-RESULTS	The frequency of epistaxis was significantly lower in Group R than Group L ( P = 0.0006 ) .
-RESULTS	Although there was no significant difference in nasal passage time between two groups , the intubation time in Group R ( 24.5 9.4 sec ) was shorter than in Group L ( 30.5 15.6 sec ; P = 0.0015 ) .
-CONCLUSIONS	Nasal intubation via the right nostril is more safely performed than with the left nostril .
-CONCLUSIONS	Because of less epistaxis and faster intubation .
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-###24847084
-BACKGROUND	Many patients with high blood pressure ( BP ) do not have antihypertensive medications appropriately intensified at clinician visits .
-BACKGROUND	We investigated whether an online spaced-education ( SE ) game among primary care clinicians can decrease time to BP target among their hypertensive patients .
-RESULTS	A 2-arm randomized trial was conducted over 52 weeks among primary care clinicians at 8 hospitals .
-RESULTS	Educational content consisted of 32 validated multiple-choice questions with explanations on hypertension management .
-RESULTS	Providers were randomized into 2 groups : SE clinicians were enrolled in the game , whereas control clinicians received identical educational content in an online posting .
-RESULTS	SE game clinicians were e-mailed 1 question every 3 days .
-RESULTS	Adaptive game mechanics resent questions in 12 or 24 days if answered incorrectly or correctly , respectively .
-RESULTS	Clinicians retired questions by answering each correctly twice consecutively .
-RESULTS	Posting of relative performance among peers fostered competition .
-RESULTS	Primary outcome measure was time to BP target ( < 140/90 mm Hg ) .
-RESULTS	One hundred eleven clinicians enrolled .
-RESULTS	The SE game was completed by 87 % of clinicians ( 48/55 ) , whereas 84 % of control clinicians ( 47/56 ) read the online posting .
-RESULTS	In multivariable analysis of 17 866 hypertensive periods among 14 336 patients , the hazard ratio for time to BP target in the SE game cohort was 1.043 ( 95 % confidence interval , 1.007-1 .081 ; P = 0.018 ) .
-RESULTS	The number of hypertensive episodes needed to treat to normalize one additional patient 's BP was 67.8 .
-RESULTS	The number of clinicians needed to teach to achieve this was 0.43 .
-CONCLUSIONS	An online SE game among clinicians generated a modest but significant reduction in the time to BP target among their hypertensive patients .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00904007 .
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-###24411313
-OBJECTIVE	Understanding attitudes to mental health issues can inform public health interventions .
-OBJECTIVE	However , low response rates may contribute to nonresponse bias .
-OBJECTIVE	In a randomized controlled trial we examined the effect of sending a prenotification postcard before the questionnaire and the placement of a short message on the survey envelope ( teaser ) on response rates to a mailed questionnaire about bulimia nervosa `` mental health literacy '' .
-METHODS	Questionnaires were mailed to 3,010 adults ( 50.6 % female and 49.4 % male ) aged 18-65years .
-METHODS	In a 2 ( pre-notification-present ; absent ) by 2 ( teaser-present ; absent ) design , questionnaire recipients were randomly allocated to the experimental strategies .
-METHODS	Outcomes considered were response rate , response time , and cost .
-RESULTS	The overall response rate was 22.0 % .
-RESULTS	Significant main effects showed higher response rates for the use of prenotification ( present = 23.6 % ; absent = 20.3 % ) , among female participants , and older participants .
-RESULTS	A significant interaction of teaser by gender indicated lower response rates for men who received the teaser but not for women .
-RESULTS	Older participants returned the questionnaire more promptly than younger participants .
-RESULTS	Females-but not males-who received the teaser were slower to return the questionnaire .
-RESULTS	Higher response rates for participants receiving the postcard compensated for increased costs , particularly for males and older participants .
-CONCLUSIONS	Response rates to a mental health postal survey can be increased through the use of prenotification .
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-###25525743
-OBJECTIVE	Endothelial function is an independent predictor of prognosis in heart failure ( HF ) subjects .
-OBJECTIVE	Statins , beyond their lipid lowering role , exert beneficial effect in patients with atherosclerosis .
-OBJECTIVE	In the present study we examined the impact of low and intermediate dose atorvastatin treatment on endothelial function , bone marrow-derived endothelial progenitor cells ( EPC ) mobilization and inflammatory status according to HF patient status .
-METHODS	We studied the effect of 4 weeks administration of atorvastatin in 26 patients with ischemic HF .
-METHODS	The study was carried out on two separate arms , one with atorvastatin 40mg/d and one with atorvastatin 10mg/d ( randomized , double-blind , cross-over design ) .
-METHODS	The number of circulating CD34 ( + ) / CD133 ( + ) / KDR ( + ) EPCs was evaluated by flow cytometry .
-METHODS	Endothelial function was evaluated by flow mediated dilation ( FMD ) in the brachial artery .
-METHODS	Serum levels of tumor necrosis factor alpha ( TNF - ) were measured by ELISA .
-RESULTS	Treatment with atorvastatin 40mg/d significantly increased circulating EPC ( p = 0.002 ) , FMD ( p = 0.001 ) and reduced TNF - ( p = 0.01 ) compared to baseline .
-RESULTS	Similarly , treatment with atorvastatin 10mg/day increased circulating EPC ( p = 0.01 ) , FMD ( p = 0.08 ) and reduced TNF - ( p = 0.01 ) compared to baseline .
-RESULTS	Interestingly , with 40mg/day atorvastatin treatment the increase in EPC was higher in subjects categorized as NYHA class II compared to subjects categorized as NYHA class III ( p = 0.03 ) .
-CONCLUSIONS	Our results confirmed the distinct impact of atorvastatin treatment on the restoration of endothelial function due to EPC mobilization in ischemic HF subjects .
-CONCLUSIONS	Moreover , these findings provide the potential clinical significance of EPC status monitoring to individualize treatment in HF subjects .
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-###24802206
-OBJECTIVE	We investigated skin microcirculation and its association with HbA1c and the incidence of ischaemic foot ulcer in patients with type 1 diabetes formerly randomised ( 1982-1984 ) to intensified conventional treatment ( ICT ) or standard treatment ( ST ) with insulin for a mean of 7.5 years .
-METHODS	We re-determined the skin microcirculation of 72 patients ( ICT 35 vs ST 37 ) from the original Stockholm Diabetes Intervention Study with iontophoresis topically applied with the following vasoactive stimuli : acetylcholine ( ACh ) ( endothelial-dependent vasodilatation ) , sodium nitroprusside ( SNP ) ( endothelial-independent vasodilatation ) , and capsaicin ( C-nociceptive-dependent vasodilatation ) .
-METHODS	HbA1c levels ( mean of 14 values/patient ) were prospectively collected between 1990 and 1995 and tested for association with skin microcirculation .
-METHODS	The patients were followed until first hospitalisation for an ischaemic foot ulcer or until 2011 .
-RESULTS	During the median 28years of follow-up , three patients developed ischaemic foot ulcers in the ICT group compared with ten in the ST group ( logrank , p = 0.035 ) .
-RESULTS	At the time of iontophoresis , HbA1c was lower in the ICT group ( median 57mmol/mol [ minimum-maximum 40-79mmol / mol ] ) compared with the ST group ( 68mmol/mol [ 41-96mmol / mol ] , p < 0.01 ) ( DCCT : ICT 7.4 % [ 5.8-9 .4 % ] vs ST 8.4 % [ 5.9-10 .9 % ] ) .
-RESULTS	Stimulated blood flow was higher in the ICT vs ST group with significantly increased perfusion units ( PU ) for : ACh ( 8.1 PU [ 4.6-24 .7 PU ] vs 5.3 PU [ 1.7-21 .4 PU ] , p < 0.01 ) ; SNP ( 8.1 PU [ 2.2-20 .1 PU ] vs 5.6 PU [ 2.3-19 .2 PU ] , p = 0.03 ) ; and capsaicin ( 5.0 PU [ 1.7-22 .9 PU ] vs 3.4 PU [ 1.5-8 .4 PU ] , p < 0.01 ) .
-RESULTS	HbA1c was associated with vasodilatation induced by ACh ( b = -0.02 , p < 0.01 ) and capsaicin ( b = -0.02 , p = 0.03 ) .
-RESULTS	HbA1c was independently associated with ACh ( b = -1.48 , p < 0.01 ) and capsaicin-induced vasodilatation ( b = -1.45 , p < 0.01 ) .
-CONCLUSIONS	Improved glycaemic control in patients with type 1 diabetes is associated with an improvement in skin microcirculation and with a lower incidence of ischaemic foot ulcers .
-BACKGROUND	ClinicalTrials.gov NCT01957930 .
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-###24651512
-OBJECTIVE	Autonomic dysfunction is an important mechanism that could explain many symptoms observed in fibromyalgia ( FM ) .
-OBJECTIVE	Exercise is an effective treatment , with benefits potentially mediated through changes in autonomic modulation .
-OBJECTIVE	Strengthening is one of the less studied exercises in FM , and the acute and chronic effects of strengthening on the autonomic system remain unknown .
-OBJECTIVE	The objective of this study was to assess the chronic effects of strengthening exercises ( STRE ) on autonomic modulation , pain perception and the quality of life ( QOL ) of FM patients .
-METHODS	Eighty sedentary women with FM ( ACR 1990 ) were randomly selected to participate in STRE or flexibility ( FLEX ) exercises in a blinded controlled trial .
-METHODS	The intensity of STRE was set at 45 % of the estimated load of 1 Repetition Maximum ( RM ) in 12 different exercises .
-METHODS	Outcomes were Visual Analog Scale ( VAS ) for pain , Heart Rate Variability ( HRV ) analysis , treadmill test , the sit and reach test ( Wells and Dillon 's Bench ) , maximal repetitions test and handgrip dynamometry ; and quality of life by the Fibromyalgia Impact Questionnaire ( FIQ ) , the Beck and Idate Trait-State Inventory ( IDATE ) , a short-form health survey ( SF-36 ) .
-RESULTS	The STRE group was more effective to strength gain for all muscles and pain control after 4 and 16 weeks ( p < 0.05 ) .
-RESULTS	The FLEX group showed higher improvements in anxiety ( p < 0.05 ) .
-RESULTS	Both groups showed improvements in the QOL , and there was no significant difference observed between the groups .
-RESULTS	There was no change in the HRV of the STRE and FLEX groups .
-CONCLUSIONS	Strengthening exercises show greater and more rapid improvements in pain and strength than flexibility exercises .
-CONCLUSIONS	Despite the benefits in fitness , pain , depression , anxiety and quality of life , no effect was observed on the autonomic modulation in both groups .
-CONCLUSIONS	This observation suggests that changes in autonomic modulation are not a target tobe clinically achieved in fibromyalgia .
-BACKGROUND	ClinicalTrials.gov NCT02004405 .
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-###24827514
-METHODS	A prospective study was performed .
-OBJECTIVE	To test the hypothesis that different pedicle screw insertion positions would increase the likelihood of superior adjacent segment degeneration ( ASD ) .
-BACKGROUND	Lumbar fusion surgery is a widely accepted treatment of lumbar diseases , such as lumbar stenosis , trauma , tumor , and spondylolisthesis .
-BACKGROUND	Fusion and clinical success rates have increased because of improvements in instrumentation and bone graft material .
-BACKGROUND	In contrast , numerous complications and problems of fusion surgery have been reported , with ASD being one of the most important .
-METHODS	This prospective study included 210 patients with low-grade isthmic spondylolisthesis .
-METHODS	From January 1999 to December 2003 , patients were randomized underwent posterolateral fusion using 2 different pedicle screw insertion positions .
-METHODS	The patients were followed up postoperatively and were assessed with regard to radiological and clinical outcomes .
-METHODS	Radiological outcomes were assessed mainly on the basis of disc degeneration , facet joint degeneration , and bone fusion .
-METHODS	Clinical outcomes were evaluated mainly with the use of visual analogue scale for pain and the Oswestry Disability Index .
-RESULTS	A total of 178 of 210 ( 84.7 % ) patients were available for at least 9-year radiological and clinical follow-up data : 85.3 % ( 87/102 ) patients in group A and 84.3 % ( 91/108 ) patients in group B. Bone fusion was achieved in all patients at the last follow-up .
-RESULTS	ASD was proven in 110 ( 61.8 % ) of 178 patients .
-RESULTS	The incidences of radiographical and symptomatic ASD were 57.9 % ( 103/178 ) and 3.9 % ( 7/178 ) , respectively .
-RESULTS	The incidence of ASD in group B was significantly lower than that in group A. Results of clinical outcomes showed lower visual analogue scale and Oswestry Disability Index scores in 2 groups than preoperative scores , but group B had greater improvement on the Oswestry Disability Index scores than group A in patients with ASD .
-CONCLUSIONS	The degeneration of superior adjacent segment is closely related to the position of the pedicle screws during lumbar fusion surgery .
-CONCLUSIONS	The position of the pedicle screw farther from the facet joint surface can reduce the degeneration of superior adjacent segment .
-METHODS	3 .
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-###25152604
-OBJECTIVE	To evaluate the clinical efficacy and safety of acupuncture and moxibustion for the treatment of active Crohn 's disease ( CD ) .
-METHODS	Ninety-two patients were equally and randomly divided into the treatment group and received herb-partitioned moxibustion combined with acupuncture , and the control group received wheat bran-partitioned moxibustion combined with superficial acupuncture .
-METHODS	The patients received three treatment sessions per week for 12 wk and were followed up for 24 wk .
-METHODS	The main outcome was evaluated using the CD Activity Index ( CDAI ) score , and the secondary outcomes were evaluated using laboratory indicators such as hemoglobin ( HGB ) , C-reactive protein ( CRP ) , erythrocyte sedimentation rate , quality-of-life , endoscopic ratings , and intestinal histology scores .
-RESULTS	The CDAI scores of both the treatment and control groups were significantly reduced after treatment compared with those measured before treatment .
-RESULTS	However , the degree of improvement in the treatment group was significantly greater than that of the control group .
-RESULTS	The improvement in symptoms in patients of the treatment group was sustained at follow-up , whereas that of the control group was not .
-RESULTS	The overall efficacy of the treatment was significantly greater than that of the control .
-RESULTS	Both groups demonstrated significant improvements in quality-of-life ratings after treatment , but the improvement was significantly greater in the treatment group than in the control group .
-RESULTS	In addition , the patients in the treatment group showed significantly increased HGB and significantly decreased CRP levels and histopathological scores at the end of treatment , whereas the control group did not exhibit significant changes .
-CONCLUSIONS	Moxibustion with acupuncture provided significant therapeutic benefits in patients with active CD beyond the placebo effect and is therefore an effective and safe treatment for active CD .
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-###24796334
-OBJECTIVE	Closed minimal extracorporeal circulation ( MECC ) systems currently do not represent the standard of surgical care for open-heart surgery .
-OBJECTIVE	Yet , considering the beneficial results reported for coronary artery bypass graft ( CABG ) surgery , we used an MECC system in aortic valve replacement ( AVR ) and analysed the effects on intraoperative microvascular perfusion in comparison with conventional open extracorporeal circulation ( CECC ) .
-METHODS	In the current study , we analysed alterations in microvascular perfusion at 4 predefined time points ( T1-T4 ) during surgical AVR utilizing orthogonal polarization spectral ( OPS ) imaging .
-METHODS	Twenty patients were randomized for being operated on utilizing either MECC or CECC .
-METHODS	Changes in functional capillary density ( FCD , cm/cm ( 2 ) ) , mircovascular blood flow velocity ( mm/s ) and vessel diameter ( m ) were analysed by a blinded investigator .
-RESULTS	After the start of extracorporeal circulation and aortic cross-clamping ( T2 ) , both groups showed a significant drop in FCD , but with a significantly higher FCD in the MECC group ( 153.1 15.0 cm/cm in the CECC group vs 160.8 12.2 cm/cm in the MECC group , P = 0.034 ) .
-RESULTS	During the late phase of the cardiopulmonary bypass ( CPB ) ( T3 ) , the FCD was still significantly depressed in both treatment groups ( 153.5 14.6 cm/cm in the CECC group , P < 0.05 vs ` T1 ' ; 159.5 12.4 cm/cm in the MECC group , P < 0.05 versus ` T1 ' ) .
-RESULTS	After termination of CPB ( T4 ) , the FCD recovered in both groups to baseline values .
-RESULTS	Microvascular blood flow velocity tended to remain at a higher level in the MECC group , whereas haemodilution during CPB was significantly reduced in the MECC group .
-CONCLUSIONS	The use of MECC in AVR did not affect procedural safety and , resulted in beneficial preservation of microvascular blood flow velocity and significantly reduced haemodilution during CPB .
-CONCLUSIONS	In contrast to CABG surgery , the use of MECC did not improve FCD during surgical AVR .
-CONCLUSIONS	Clinical advantages possibly resulting from attenuated haemodilution and preservation of microvascular blood flow velocity require further validation in larger patient cohorts .
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-###24826855
-OBJECTIVE	To compare pelvic ultrasound simulators ( PSs ) with live models ( LMs ) for training in transvaginal sonography ( TVS ) .
-METHODS	The authors conducted a prospective , randomized controlled trial of 145 eligible medical students trained in TVS in 2011-2012 with either a PS or an LM .
-METHODS	A patient educator was used for LM training .
-METHODS	Simulated intrauterine and ectopic pregnancy models were used for PS training .
-METHODS	Students were tested using a standardized patient who evaluated their professionalism .
-METHODS	A proctor , blinded to training type , scored their scanning technique .
-METHODS	Digital images were saved for blinded review .
-METHODS	Students rated their training using a Likert scale ( 0 = not very well ; 10 = very well ) .
-METHODS	The primary outcome measure was students ' overall performance on a 40-point assessment tool for professionalism , scanning technique , and image acquisition .
-METHODS	Poisson regression and Student t test were used for comparisons .
-RESULTS	A total of 134 students participated ( 62 trained using a PS ; 72 using an LM ) .
-RESULTS	Mean overall test scores were 56 % for the PS group and 69 % for the LM group ( P = .001 ) .
-RESULTS	A significant difference was identified in scanning technique ( PS , 60 % versus LM , 73 % ; P = .001 ) and image acquisition ( PS , 37 % versus LM , 59 % ; P = .001 ) .
-RESULTS	None was observed for professionalism .
-RESULTS	The PS group rated their training experience at 4.4 , whereas the LM group rated theirs at 6.2 ( P < .001 ) .
-CONCLUSIONS	Simulators do not perform as well as LMs for training novices in TVS , but they may be useful as an adjunct to LM training .
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-###24408212
-BACKGROUND	Expectancies regarding treatment assignment may influence outcomes in placebo-controlled trials above and beyond actual treatment assignment .
-BACKGROUND	For smoking pharmacotherapies , guessing enrollment in the active medication treatment is associated with higher abstinence rates .
-BACKGROUND	However , placebo-controlled trials of smoking pharmacotherapies rarely assess perceived treatment assignment and those that do only collect this information after reaching full dosage .
-OBJECTIVE	To determine the temporal relationship between treatment expectancies and smoking-related variables , we assessed the impact of treatment guess during a placebo-controlled laboratory study of varenicline on measures of craving , smoking reward , and smoking reinforcement .
-OBJECTIVE	We hypothesized that treatment guess at mid-titration would influence smoking-related measures at full dosage , above and beyond actual medication effects .
-OBJECTIVE	We also explored factors related to guess stability and differences in blind fidelity between mid-drug titration and full dosage .
-METHODS	Eighty-eight participants completed laboratory assessments at baseline , mid-titration , and full dosage that involved self-report and behavioral measures of tonic craving , cue-provoked craving , smoking reward , and smoking reinforcement .
-METHODS	Participants guessed treatment assignment at mid-titration and full dosage .
-RESULTS	Generalized linear models confirmed that , beyond actual treatment assignment , treatment guess improved model fit for both self-report and behavioral smoking-related measures .
-RESULTS	Further , accuracy of treatment guess improved from titration to full dosage , and specific demographic factors ( e.g. , gender , race ) were associated with type of treatment guess and guess stability across time .
-CONCLUSIONS	These results reinforce the importance of assessing perceived treatment assignment repeatedly during placebo-controlled trials and suggest that treatment expectancies during titration can affect outcomes once full dosage has been reached .
-
-###25143296
-BACKGROUND	We evaluated chr6q25 .3 organic cation transporter gene ( SLC22A1 , SLC22A2 , SLC22A3 ) variation and response to smoking cessation therapies .
-BACKGROUND	The corresponding proteins are low-affinity transporters of choline , acetylcholine and monoamines , and smoking cessation pharmacotherapies expressed in multiple tissues .
-METHODS	We selected 7 common polymorphisms for mega-regression analysis .
-METHODS	We assessed additive model association of polymorphisms with 7-day point prevalence abstinence overall and by assigned pharmacotherapy at end of treatment and at 6 months among European-ancestry participants of 7 randomized controlled trials adjusted for demographic , population genetic , and trial covariates .
-RESULTS	Initial results were obtained in 6 trials with 1,839 participants .
-RESULTS	Nominally statistically significant associations of 2 SLC22A2 polymorphisms were observed : ( 1 ) with rs316019 at 6 months , overall ( [ c. 808T > G ; p.Ser270Ala ] , OR = 1.306 , 95 % CI = 1.034-1 .649 , p = .025 ) , and among those randomized to nicotine replacement therapy ( NRT ) ( OR = 1.784 , 95 % CI = 1.072-2 .970 , p = .026 ) ; and ( 2 ) with rs316006 ( c.1502-529A > T ) among those randomized to varenicline ( OR = 1.420 , 95 % CI = 1.038-1 .944 , p = .028 , OR = 1.362 , 95 % CI = 1.001-1 .853 , p = .04 ) at end of treatment and 6 months .
-RESULTS	Individuals randomized to NRT from a seventh trial were genotyped for rs316019 ; rs316019 was associated with a nominally statistically significant effect on abstinence overall at 6 months among 2,233 participants ( OR = 1.249 , 95 % CI = 1.007-1 .550 , p = .043 ) .
-CONCLUSIONS	The functional OCT2 Ser270Ala polymorphism is nominally statistically significantly associated with abstinence among European-ancestry treatment-seeking smokers after adjustments for pharmacotherapy , demographics , population genetics , and without adjustment for multiple testing of 7 SNPs .
-CONCLUSIONS	Replication of these preliminary findings in additional randomized controlled trials of smoking cessation therapies and from multiple continental populations would describe another pharmacogenetic role for SLC22A2/OCT2 .
-
-###24375313
-OBJECTIVE	Presbyphonia is common among elderly individuals , yet few studies have evaluated behavioral treatment approaches for presbyphonia .
-OBJECTIVE	The primary aim of this study was to assess the short-term efficacy of two types of voice therapy-vocal function exercises ( VFE ) and phonation resistance training exercise ( PhoRTE ) therapy-in the treatment of presbyphonia .
-OBJECTIVE	The secondary aim was to determine if differences in adherence and treatment satisfaction existed between the two therapy approaches .
-METHODS	Prospective , randomized , controlled .
-METHODS	Preliminary data from 16 elderly participants with presbyphonia randomly assigned to VFE , PhoRTE , or a no-treatment control group ( CTL ) were analyzed .
-METHODS	Before and after a 4-week intervention period , participants completed the Voice-Related Quality of Life ( V-RQOL ) questionnaire and a perceived phonatory effort ( PPE ) task .
-METHODS	Additionally , participants receiving treatment completed weekly practice logs and a posttreatment satisfaction questionnaire .
-RESULTS	Preliminary data revealed VFE and PhoRTE groups demonstrated a significant improvement in V-RQOL scores .
-RESULTS	However , only PhoRTE demonstrated a significant reduction in PPE , as suggested by the study 's causal model .
-RESULTS	The CTL group did not demonstrate significant changes .
-RESULTS	Numerically , VFE registered slightly greater adherence to home practice recommendations than did PhoRTE , but PhoRTE perceived greater treatment satisfaction than VFE .
-CONCLUSIONS	Findings provide new evidence regarding the efficacy of voice therapy exercises in the treatment of age-related dysphonia and suggest PhoRTE therapy as another treatment method for improved voice-related quality of life and reduced perceived vocal effort in this population .
-
-###24762025
-OBJECTIVE	To determine whether a flexible vaccination regimen provides protection against challenge exposure with a virulent Leptospira borgpetersenii serovar Hardjo isolate .
-METHODS	Fifty-five 4-week-old calves seronegative for antibodies against L borgpetersenii serovar Hardjo .
-METHODS	Calves were assigned to 3 groups and administered 2 doses of adjuvant ( control calves ; n = 11 ) , 1 dose of serovar Hardjo bacterin and 1 dose of adjuvant ( 22 ) , or 2 doses of the serovar Hardjo bacterin ( 22 ) ; there was a 16-week interval between dose administrations .
-METHODS	Three weeks after the second dose , all calves were challenge exposed by use of conjunctival instillation of a heterologous strain of L borgpetersenii serovar Hardjo for 3 consecutive days .
-METHODS	Urine samples for leptospiral culture were collected for 5 weeks after challenge exposure ; at that time , all calves were euthanized and kidney samples collected for leptospiral culture .
-RESULTS	Antibody titers increased in both leptospiral-vaccinated groups of calves .
-RESULTS	A significant increase in antibody titers against L borgpetersenii serovar Hardjo was detected after administration of the second dose of L borgpetersenii serovar Hardjo bacterin and challenge exposure .
-RESULTS	In 10 of 11 adjuvant-treated control calves , serovar Hardjo was isolated from both urine and kidney samples .
-RESULTS	Leptospira borgpetersenii serovar Hardjo was not isolated from the urine or kidney samples obtained from any of the 21 remaining calves that received 1 dose of bacterin or the 20 remaining calves that received 2 doses of bacterin .
-CONCLUSIONS	Protection in young calves was induced by vaccination with 1 or 2 doses of a serovar Hardjo bacterin .
-
-###24928761
-BACKGROUND	An athlete is thought to reduce head acceleration after impact by contracting the cervical musculature , which increases the effective mass of the head .
-OBJECTIVE	To compare the odds of sustaining higher magnitude in-season head impacts between athletes with higher and lower preseason performance on cervical muscle characteristics .
-METHODS	Cohort study ; Level of evidence , 2 .
-METHODS	Forty-nine high school and collegiate American football players completed a preseason cervical testing protocol that included measures of cervical isometric strength , muscle size , and response to cervical perturbation .
-METHODS	Head impact biomechanics were captured for each player using the Head Impact Telemetry System .
-METHODS	A median split was used to categorize players as either high or low performers for each of the following outcome measures : isometric strength ( peak torque , rate of torque development ) , muscle size ( cross-sectional area ) , and response to cervical perturbation ( stiffness , angular displacement , muscle onset latency ) .
-METHODS	The odds of sustaining moderate and severe head impacts were computed against the reference odds of sustaining mild head impacts across cervical characteristic categorizations .
-RESULTS	Linemen with stronger lateral flexors and composite cervical strength had about 1.75 times ' increased odds of sustaining moderate linear head impacts rather than mild impacts compared with weaker linemen .
-RESULTS	Players who developed extensor torque more quickly had 2 times the increased odds of sustaining severe linear head impacts ( odds ratio [ OR ] , 2.10 ; 95 % CI , 1.08-4 .05 ) rather than mild head impacts .
-RESULTS	However , players with greater cervical stiffness had reduced odds of sustaining both moderate ( OR , 0.77 ; 95 % CI , 0.61-0 .96 ) and severe ( OR , 0.64 ; 95 % CI , 0.46-0 .89 ) head impacts compared with players with less cervical stiffness .
-CONCLUSIONS	The study findings showed that greater cervical stiffness and less angular displacement after perturbation reduced the odds of sustaining higher magnitude head impacts ; however , the findings did not show that players with stronger and larger neck muscles mitigate head impact severity .
-
-###24444257
-OBJECTIVE	To develop a new radiography-based score to assess the potential of bacteria to cause odontogenic infections derived from the occurrence of bacteria at small or large radiographical lesions .
-METHODS	The patients analyzed were a sub-population from a large randomized clinical trial comparing moxifloxacin and clindamycin in the treatment of inflammatory infiltrates and odontogenic abscesses .
-METHODS	Routine radiographs were used to analyze the area of the periapical radiolucent lesions .
-METHODS	Lesions were stratified by their radiographically measured area as large ( > 9 mm ( 2 ) ) or small ( 9 mm ( 2 ) ) .
-METHODS	A risk ratio was calculated for each species from the frequency of their occurrence in large vs in small lesions .
-RESULTS	Fifty-one patients , 19 with abscesses and 32 with infiltrates , were evaluated .
-RESULTS	Overall , the radiographical lesion areas ranged from 0.4-46 .2 mm ( 2 ) ( median = 9 mm ( 2 ) ) .
-RESULTS	An increased risk ( risk ratio > 1 ) to occur at large abscess lesions was observed for Prevotella ( P. ) oralis , P. buccae , P. oris , P. intermedia , Fusobacterium nucleatum and Streptococcus ( Strep . )
-RESULTS	anginosus group .
-RESULTS	An increased risk to occur at large infiltrate lesions was found for Strep .
-RESULTS	salivarius , Strep .
-RESULTS	parasanguis , Strep .
-RESULTS	anginosus group , Capnocytophaga spp. , Neisseria ( N. ) sicca , Neisseria spp. , Staphylococcus ( Staph . )
-RESULTS	aureus , P. intermedia , P. buccae , Prevotella spp .
-RESULTS	and P. melaninogenica .
-CONCLUSIONS	The radiography-based score suggests that certain Prevotella spp. , F. nucleatum and Strep .
-CONCLUSIONS	anginosus groups play a crucial role in the pathogenesis of odontogenic abscesses , and that various streptococci , Neisseria spp. , Capnocytophaga spp. , Staph .
-CONCLUSIONS	aureus and Prevotella spp .
-CONCLUSIONS	are involved in the pathogenesis of odontogenic infiltrates .
-
-###24524222
-BACKGROUND	The role of fixed airflow obstruction ( FAO ) in asthma is unclear .
-OBJECTIVE	To assess the relationship between FAO and clinical features of asthma and the effect of FAO on treatment response .
-METHODS	Post hoc descriptive analysis of data stratified by FAO category ( screening post-albuterol FEV1/FVC < lower limit of normal [ LLN ] [ FAO + ] or LLN [ FAO - ] ) from two 12-week , randomized , placebo-controlled studies of budesonide/formoterol or the monocomponents in mild-moderate ( study I ; aged 6 years ; NCT00651651 ; placebo run-in ) or moderate-severe ( study II ; 12 years ; NCT00652002 ; budesonide run-in ) asthma patients .
-RESULTS	At baseline , FAO + versus FAO - patients were more likely male and had longer asthma duration and worse pulmonary function .
-RESULTS	During the treatment period , lung function and asthma control measures with placebo were generally worse in FAO + versus FAO - patients .
-RESULTS	Budesonide was effective on most end points in both FAO + and FAO - patients .
-RESULTS	In contrast to FAO - patients , FAO + patients were unresponsive to formoterol monotherapy in both study populations .
-RESULTS	Consistently greater improvements in most end points ( including worsening of asthma as predefined by specific lung function parameters or clinical symptoms ) were observed moving from formoterol to budesonide to budesonide/formoterol in both FAO + and FAO - patients , with generally greater than additive effects on lung function with budesonide/formoterol in FAO + patients .
-CONCLUSIONS	FAO + patients tended to be more impaired and at greater risk for an asthma event versus FAO - patients .
-CONCLUSIONS	While FAO + patients were non-responsive to formoterol monotherapy , they retained responsiveness to budesonide and had the greatest lung function and control responses to budesonide/formoterol that were similar to or greater than responses of FAO - patients .
-
-###24336915
-OBJECTIVE	Inhibition of inflammatory cytokines may have therapeutic effects in diabetic retinopathy ( DR ) .
-OBJECTIVE	To compare aqueous and vitreous levels of 17 inflammatory cytokines in patients treated preoperatively with topical ketorolac tromethamine , 0.45 % , or placebo before pars plana vitrectomy for complications related to proliferative DR ( PDR ) .
-METHODS	A prospective , randomized , placebo-controlled , patient-masked interventional study performed in a university academic hospital included 20 eyes from 20 patients undergoing pars plana vitrectomy for complications of PDR .
-METHODS	Eyes were randomized to ketorolac tromethamine , 0.45 % ( Acuvail ) , or placebo 4 times daily for 3 days before pars plana vitrectomy .
-METHODS	Undiluted aqueous and vitreous samples were taken at the time of surgery and immediately frozen at -80 C.
-METHODS	Aqueous and vitreous levels of prostaglandin E2 and 16 other inflammatory cytokines implicated in the pathogenesis of DR.
-RESULTS	Prostaglandin E2 , platelet-derived growth factor ( PDGF ) AA , eotaxin , vascular endothelial growth factor , interferon - inducible protein of 10 kDa , monocyte chemoattractant protein 1 , growth-related oncogene , interleukin 6 , interleukin 8 ( IL-8 ) , and tumor necrosis factor were detectable in the aqueous and vitreous of at least half of the eyes , and these cytokines were analyzed further .
-RESULTS	Aqueous levels were lower in the ketorolac group for all cytokines detected , but only the difference in IL-8 was statistically significant ( 52 % reduction ; P = .04 ) .
-RESULTS	Levels of IL-8 ( 41 % reduction ; P = .002 ) and PDGF-AA ( 21 % reduction ; P = .009 ) were significantly lower in the vitreous of patients treated with ketorolac .
-CONCLUSIONS	Topical ketorolac tromethamine , 0.45 % , significantly lowered aqueous IL-8 levels and vitreous IL-8 and PDGF-AA levels in this series of eyes , suggesting that it may cause meaningful inhibition of inflammatory cytokines implicated in the pathogenesis of DR.
-BACKGROUND	clinicaltrials.gov Identifier : NCT01609881 .
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-###24686130
-BACKGROUND	The effects of the DASH ( Dietary Approaches to Stop Hypertension ) diet on inflammation in childhood metabolic syndrome ( MetS ) have still to be identified .
-OBJECTIVE	To examine the effects of the DASH diet on markers of systemic inflammation in adolescents with MetS .
-METHODS	In this randomized , cross-over clinical trial , 60 postpubescent girls with MetS were randomly assigned to receive either the DASH diet menu cycles or usual dietary advice ( UDA ) for 6 weeks .
-METHODS	After a 4-week washout period , participants were crossed over to the alternate arm .
-METHODS	The DASH diet was designed to maintain the current body weight .
-METHODS	This diet contained high amounts of fruit , vegetables and low-fat dairy products and was low in saturated fats and cholesterol .
-METHODS	UDA consisted of general oral advice and written information about healthy food choices based on the Healthy Eating Plate .
-METHODS	Compliance to the DASH diet was assessed through quantification of plasma vitamin C levels .
-METHODS	Fasting venous blood samples were taken 4 times from each participant : at baseline and at the end of each study arm .
-METHODS	Circulating levels of biomarkers of systemic inflammation were quantified according to standard protocols .
-RESULTS	Mean ( SD ) age and weight of participants was 14.2 years ( 1.7 ) and 69 kg ( 14.5 ) , respectively .
-RESULTS	Serum vitamin C levels tended to increase during the DASH phase compared with the UDA phase ( 16.8 12.9 vs. -13.8 9.7 ng/dl , respectively , p = 0.06 ) indicating a relatively good compliance to the DASH diet .
-RESULTS	Adherence to the DASH diet , compared to the UDA , had a significant effect on serum high-sensitivity C-reactive protein levels ( p = 0.002 ) .
-RESULTS	This effect remained significant even after adjustment for weight changes and after further controlling for changes in lipid profiles .
-RESULTS	We did not observe any significant effect of intervention on levels of serum tumor necrosis factor-alpha , interleukin ( IL ) -2 , IL-6 and adiponectin , in either the crude or adjusted models .
-RESULTS	There were no significant group * time interactions for any dependent variable , except for IL-6 ; this was close to the significant level .
-CONCLUSIONS	In summary , consumption of the DASH eating pattern for 6 weeks may reduce circulating levels of hs-CRP among adolescents with MetS .
-CONCLUSIONS	Other inflammatory markers were not affected by the DASH diet .
-
-###25601341
-BACKGROUND	Abiraterone acetate plus prednisone significantly improved radiographic progression-free survival compared with placebo plus prednisone in men with chemotherapy-naive castration-resistant prostate cancer at the interim analyses of the COU-AA-302 trial .
-BACKGROUND	Here , we present the prespecified final analysis of the trial , assessing the effect of abiraterone acetate plus prednisone on overall survival , time to opiate use , and use of other subsequent therapies .
-METHODS	In this placebo-controlled , double-blind , randomised phase 3 study , 1088 asymptomatic or mildly symptomatic patients with chemotherapy-naive prostate cancer stratified by Eastern Cooperative Oncology performance status ( 0 vs 1 ) were randomly assigned with a permuted block allocation scheme via a web response system in a 1:1 ratio to receive either abiraterone acetate ( 1000 mg once daily ) plus prednisone ( 5 mg twice daily ; abiraterone acetate group ) or placebo plus prednisone ( placebo group ) .
-METHODS	Coprimary endpoints were radiographic progression-free survival and overall survival analysed in the intention-to-treat population .
-METHODS	The study is registered with ClinicalTrials.gov , number NCT00887198 .
-RESULTS	At a median follow-up of 49.2 months ( IQR 47.0-51 .8 ) , 741 ( 96 % ) of the prespecified 773 death events for the final analysis had been observed : 354 ( 65 % ) of 546 patients in the abiraterone acetate group and 387 ( 71 % ) of 542 in the placebo group .
-RESULTS	238 ( 44 % ) patients initially receiving prednisone alone subsequently received abiraterone acetate plus prednisone as crossover per protocol ( 93 patients ) or as subsequent therapy ( 145 patients ) .
-RESULTS	Overall , 365 ( 67 % ) patients in the abiraterone acetate group and 435 ( 80 % ) in the placebo group received subsequent treatment with one or more approved agents .
-RESULTS	Median overall survival was significantly longer in the abiraterone acetate group than in the placebo group ( 34.7 months [ 95 % CI 32.7-36 .8 ] vs 30.3 months [ 28.7-33 .3 ] ; hazard ratio 0.81 [ 95 % CI 0.70-0 .93 ] ; p = 0.0033 ) .
-RESULTS	The most common grade 3-4 adverse events of special interest were cardiac disorders ( 41 [ 8 % ] of 542 patients in the abiraterone acetate group vs 20 [ 4 % ] of 540 patients in the placebo group ) , increased alanine aminotransferase ( 32 [ 6 % ] vs four [ < 1 % ] ) , and hypertension ( 25 [ 5 % ] vs 17 [ 3 % ] ) .
-CONCLUSIONS	In this randomised phase 3 trial with a median follow-up of more than 4 years , treatment with abiraterone acetate prolonged overall survival compared with prednisone alone by a margin that was both clinically and statistically significant .
-CONCLUSIONS	These results further support the favourable safety profile of abiraterone acetate in patients with chemotherapy-naive metastatic castration-resistant prostate cancer .
-BACKGROUND	Janssen Research & Development .
-
-###25492853
-BACKGROUND	Chronic low back pain is one of the four most common diseases in the world with great socioeconomic impact .
-BACKGROUND	Supervised exercise therapy is one of the treatments suggested for this condition ; however , the recommendation on the best type of exercise is still unclear .
-BACKGROUND	The Pilates method of exercise is effective in reducing pain and disability in these patients , as well as the analgesia promoted by interferential current .
-BACKGROUND	Currently , the literature lacks information on the efficacy of the association of these two techniques in the short - and medium-term than performing one of the techniques isolated .
-BACKGROUND	The objective of this study will be to evaluate the efficacy of adding interferential current to the Pilates method exercises for the treatment of patients with chronic nonspecific low back pain in the short - and medium-term .
-METHODS	This study will be a randomized controlled trial with two arms and blinded evaluator , conducted at an outpatient Physical Therapy Department in Brazil .
-METHODS	Patients with nonspecific chronic low back pain and pain equal to or greater than 3 in the Pain Numerical Rating Scale ( 0/10 ) will be randomly assigned to one of two groups : Group with active interferential current + Pilates ( n = 74 ) will be submitted to the active interferential current associated to the modified Pilates exercises , and Group with sham interferential current + Pilates ( n = 74 ) will be submitted to the sham interferential current associated with the modified Pilates exercises during 18 sessions .
-METHODS	The outcomes pain intensity , pressure pain threshold , general and specific disability , global perceived effect and kinesiophobia will be evaluated by a blinded assessor at baseline , six weeks and six months after randomization .
-CONCLUSIONS	Because of the study design , blinding of the participants and the therapists involved in the study will not be possible .
-CONCLUSIONS	The results of this study could contribute to the process of clinical decision - making for the improvement of pain and disability in participants with nonspecific chronic low back pain .
-BACKGROUND	ClinicalTrials.gov NCT01919268 .
-
-###25509728
-OBJECTIVE	To verify the regulatory effects of acupuncture on exercise tolerance in patients with chronic obstructive pulmonary disease ( COPD ) at stable phase .
-METHODS	Thirty cases of COPD were randomly divided into a treatment group ( 16 cases ) and a placebo group ( 14 cases ) .
-METHODS	Based on specified aerobic exercise , acupuncture was applied in the treatment group and placebo acupuncture was used in the placebo group .
-METHODS	The acupoints included Danzhong ( CV 17 ) , Rugen ( ST 18 ) , Guanyuan ( CV 4 ) , Zhongwan ( CV 12 ) , Tianshu ( ST 25 ) and so on .
-METHODS	The needle did not penetrate into the skin for the placebo group .
-METHODS	The treatment was required for 2 to 3 times per week for totally 5 weeks .
-METHODS	The indices of exercise tolerance , including 6-min walking distance ( 6-MWD ) , exercise time , maximum oxygen uptake ( VO2max ) forced expiratory volume in 1 second ( FEV1 ) / forced vital capacity ( FVC ) , maximum ventilatory volume ( MVV ) , St. George respiratory questionnaire ( SGRQ ) were observed in two groups before and after treatment .
-RESULTS	( 1 ) Exercise tolerance : the differences of 6-MWD and exercise time were statistically significant between groups , which were more superior in the treatment group ( both P < 0.01 ) ; the VO2max was significantly increased after treatment in the treatment group ( P < 0.05 ) , but there was no difference between two groups ( P > 0.05 ) .
-RESULTS	( 2 ) Pulmonary ventilation function : the differences of FEV1 % , FEV1/FVC and MVV % were statistically significant between groups , which were more superior in the treatment group ( P < 0.05 , P < 0.01 ) ; ( 3 ) SGRQ : the SGRQ was significantly improved after treatment in the treatment group ( P < 0.05 ) , but there was no difference between two groups ( P > 0.05 ) .
-CONCLUSIONS	The acupuncture could improve the exercise tolerance in patients with chronic obstructive pulmonary disease at stable phase , and shorten the onset time of aerobic exercise .
-CONCLUSIONS	Besides , acupuncture combined with aerobic exercise could effectively improve the pulmonary function .
-
-###24519025
-BACKGROUND	Currently , task time and errors are often used as performance parameters in laparoscopic training .
-BACKGROUND	Training with the focus on task time improvement alone results in fast , but possibly less controlled , instrument movements and therefore suboptimal tissue handling skills .
-METHODS	Twenty-five medical students were randomly assigned in two groups .
-METHODS	Both groups performed a tissue manipulation task six times .
-METHODS	During this training session , the time feedback group ( n = 13 ) received real-time visual feedback of the task time .
-METHODS	The force feedback group ( n = 12 ) received real-time visual feedback of the tissue manipulation force .
-METHODS	After the training sessions , participants in both groups performed an entirely different task without visual feedback .
-METHODS	Task time , force , and motion parameters of this posttest were used to compare the technical skills of the medical students .
-RESULTS	The training data of the group that received force feedback showed a learning curve for the mean and max absolute force , max force area , force volume , task time , and path length of both instruments .
-RESULTS	The data from the group that received time feedback showed a learning curve for the max force , task time , and path length of both instruments .
-RESULTS	In the posttest , the parameters of mean absolute force ( p = 0.039 ) , max force ( p = 0.041 ) , and force volume ( p = 0.009 ) showed a significant difference in favor of the group that received force feedback .
-CONCLUSIONS	The learning curves and the posttest indicate that training with visual force feedback improves tissue handling skills with no negative effect on the task time and instrument motions .
-CONCLUSIONS	Conventional laparoscopic training with visual time feedback improves instrument motion and task time , but it does not improve tissue manipulation skills .
-
-###24680587
-OBJECTIVE	To determine the association of body mass index ( BMI ) on complications , recurrence , and survival in GOG LAP2 , a randomized comparison of laparoscopic versus open staging in clinically early stage uterine cancer ( EC ) .
-METHODS	An ancillary data analysis of GOG LAP2 was performed .
-METHODS	Categorical variables were compared using Pearson chi-square test and continuous variables using the Wilcoxon-Mann-Whitney and Kruskal-Wallis tests by BMI group .
-METHODS	Survival was estimated using the Kaplan-Meier method .
-METHODS	Cox proportional hazards model was used to evaluate independent prognostic factors on survival .
-METHODS	Statistical tests were two-tailed with = 0.05 , except where noted .
-METHODS	Statistical analyses utilized R programming language .
-RESULTS	2596 women were included .
-RESULTS	BMI ( kg/m ( 2 ) ) groups were < 25 ( 29.5 % ) , 25-30 ( 28.2 % ) , 30-35 ( 21 % ) , 35-40 ( 10.9 % ) , and 40 ( 10.4 % ) .
-RESULTS	Stage ( p = 0.021 ) , grade ( p < 0.001 ) , and histology ( p = 0.005 ) differed by BMI .
-RESULTS	Obese women were less likely to have high risk ( HR ) disease ( + lymph nodes/ovaries/cytology ) or tumor features that met GOG99 high intermediate risk ( HIR ) criteria ( p < 0.001 ) .
-RESULTS	Adjuvant therapy ( p = 0.151 ) and recurrence ( p = 0.46 ) did not vary by BMI .
-RESULTS	Hospitalization > 2days , antibiotic use , wound infection , and venous thrombophlebitis were higher with BMI 40 .
-RESULTS	BMI ( p = 0.016 ) , age ( p < 0.0001 ) , race ( p = 0.033 ) , and risk group ( p < 0.0001 ) predicted all-cause mortality .
-RESULTS	BMI was not predictive of disease-specific survival ( p = 0.79 ) , but age ( p = 0.032 ) and risk group ( p < 0.0001 ) were significant factors .
-CONCLUSIONS	Obese women have greater surgical risk and lower risk of metastatic disease .
-CONCLUSIONS	BMI is associated with all-cause but not disease-specific mortality , emphasizing the detrimental effect of obesity ( independent of EC ) , which deserves particular attention .
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-###24589573
-OBJECTIVE	To evaluate the efficacy of corneal debridement in the treatment of clinically diagnosed cases of microsporidial keratoconjunctivitis .
-METHODS	Prospective , double-masked randomized clinical trial .
-METHODS	Patients with clinical features such as multifocal , coarse , raised , punctate , round to oval epithelial lesions in the cornea in slit-lamp examination with mild to moderate conjunctival congestion , suggestive of microsporidial superficial keratoconjunctivitis , were included in the prospective study .
-METHODS	All patients were randomized into 2 groups .
-METHODS	Group 1 patients underwent debridement with the help of a sterile # 15 blade on a Bard-Parker handle , whereas only conjunctival swabs were taken from Group 2 patients .
-METHODS	All patients were treated with ocular lubricants .
-RESULTS	One hundred and twenty patients with clinical features suggestive of microsporidial superficial keratoconjunctivitis were included in the study .
-RESULTS	The mean age was 34.3 13.6 years ( Group 1 ) and 35.8 16.2 years ( Group 2 ) ( P = .59 ) .
-RESULTS	The mean duration of symptoms was 6.8 3.9 days ( Group 1 ) and 7.2 4.6 days ( Group 2 ) ( P = .61 ) .
-RESULTS	Baseline characteristics showed no difference between the 2 groups .
-RESULTS	The primary outcome was the time from the presentation to complete resolution ( ie , absence of corneal lesions ) of the clinical signs and symptoms .
-RESULTS	The secondary outcomes were final visual acuity and residual corneal side effects and/or scarring , if any .
-RESULTS	The mean resolution time of the corneal lesions was 5.7 4.0 days ( Group 1 ) and 5.9 3.9 days ( Group 2 ) ( P = .83 ) .
-RESULTS	There was no significant difference in final visual outcome in the 2 groups .
-RESULTS	No serious side effects were observed .
-CONCLUSIONS	Debridement does not have any significant advantage in terms of resolution of the corneal lesions and final visual outcome in cases of microsporidial keratoconjunctivitis .
-
-###25339642
-OBJECTIVE	Evidence regarding the cost-effectiveness of joint protection and hand exercises for the management of hand OA is not well established .
-OBJECTIVE	The primary aim of this study is to assess the cost-effectiveness ( cost-utility ) of these management options .
-OBJECTIVE	In addition , given the absence of consensus regarding the conduct of economic evaluation alongside factorial trials , we compare different analytical methodologies .
-METHODS	A trial-based economic evaluation to assess the cost-utility of joint protection only , hand exercises only and joint protection plus hand exercises compared with leaflet and advice was undertaken over a 12 month period from a UK National Health Service perspective .
-METHODS	Patient-level mean costs and mean quality-adjusted life years ( QALYs ) were calculated for each trial arm .
-METHODS	Incremental cost-effectiveness ratios ( ICERs ) were estimated and cost-effectiveness acceptability curves were constructed .
-METHODS	The base case analysis used a within-the-table analysis methodology .
-METHODS	Two further methods were explored : the at-the-margins approach and a regression-based approach with or without an interaction term .
-RESULTS	Mean costs ( QALYs ) were 58.46 ( s.d. 0.662 ) for leaflet and advice , 92.12 ( s.d. 0.659 ) for joint protection , 64.51 ( s.d. 0.681 ) for hand exercises and 112.38 ( s.d. 0.658 ) for joint protection plus hand exercises .
-RESULTS	In the base case , hand exercises were the cost-effective option , with an ICER of 318 per QALY gained .
-RESULTS	Hand exercises remained the most cost-effective management strategy when adopting alternative methodological approaches .
-CONCLUSIONS	This is the first trial evaluating the cost-effectiveness of occupational therapy-supported approaches to self-management for hand OA .
-CONCLUSIONS	Our findings showed that hand exercises were the most cost-effective option .
-
-###24256157
-OBJECTIVE	Supervised consumption of opiate substitution treatment is standard practice in the UK yet little is known about the patient experience of this treatment modality .
-OBJECTIVE	This study aimed to assess the patient experience of receiving supervised compared with unsupervised consumption of methadone or buprenorphine .
-METHODS	A qualitative study utilising a grounded theory approach to analysis .
-METHODS	Participants ( 29 ) were theoretically sampled from 293 opioid-dependent patients entering a randomised controlled trial of opiate substitution treatment across four urban and community drug treatment services in England .
-METHODS	Multidisciplinary staff were recruited for interviews and focus groups ( 55 ) .
-RESULTS	Supervised consumption was accepted by patients , despite causing practical limitations and raising issues of privacy and stigma .
-RESULTS	Patients recognised that establishing a daily routine away from illicit drugs was useful early in treatment .
-RESULTS	However , having flexibility to move away from supervision was important .
-RESULTS	Unsupervised patients reported that they ultimately preferred this treatment approach and appreciated the trust and sense of reward that unsupervised treatment bought .
-RESULTS	Clinicians expressed confidence in supervised prescribing and reduced risk for their patients , but also concern that a minority of individuals may remain inappropriately supervised for lengthy time periods .
-CONCLUSIONS	This study provides an important patient perspective and is the first in-depth qualitative investigation directly comparing supervision with unsupervised treatment to consider both patient and professional perspectives .
-CONCLUSIONS	Overall , our qualitative findings suggest that flexibly timed discontinuation of supervision may have positive benefits .
-
-###26322834
-OBJECTIVE	To identify eyes of patients with diabetes type 2 that show progression of retinal disease within a 1-year period using noninvasive techniques .
-METHODS	Three hundred seventy-four type 2 diabetic patients with mild nonproliferative diabetic retinopathy ( Early Treatment Diabetic Retinopathy Study [ ETDRS ] level 20 or 35 ) were included in a 12-month prospective observational study to identify retinopathy progression .
-METHODS	Four visits were scheduled at 0 , 3 , 6 , and 12 months .
-METHODS	Microaneurysm ( MA ) activity using the RetmarkerDR and retinal thickness using spectral-domain optical coherence tomography ( SD-OCT ) were assessed by a central reading center at all visits and ETDRS severity level in the first and last visits .
-RESULTS	Three hundred thirty-one eyes/patients completed the study .
-RESULTS	Microaneurysm formation rate greater than or equal to 2 was present in 68.1 % of the eyes and MA turnover greater than or equal to 6 in 54.0 % at month 6 .
-RESULTS	Higher MA turnover values were registered in eyes that showed progression in ETDRS severity level ( P < 0.03 ) .
-RESULTS	There were also significant correlations between increased microaneurysm activity and increases in retinal thickness .
-RESULTS	Spectral-domain OCT identified clinical macular edema in 24 eyes/patients ( 6.7 % ) and subclinical macular edema in 104 eyes/patients ( 28.9 % ) at baseline .
-RESULTS	Progression of retinal thickening was registered in eyes that had either subclinical or clinical macular edema at baseline .
-CONCLUSIONS	Changes in MA activity measured with RetmarkerDR and in central retinal thickness in eyes with mild nonproliferative diabetic retinopathy and diabetes type 2 are able to identify eyes at risk of progression .
-CONCLUSIONS	These eyes/patients should be selected for inclusion in future clinical trials of drugs targeted to prevent diabetic retinopathy progression to vision-threatening complications .
-CONCLUSIONS	( ClinicalTrials.gov number , NCT01145599 . )
-
-###25584994
-OBJECTIVE	We evaluated the association between cardiovascular autonomic neuropathy , and erectile dysfunction and lower urinary tract symptoms in men with type 1 diabetes .
-METHODS	Male type 1 diabetes participants ( 635 ) in the DCCT/EDIC were studied .
-METHODS	Cardiovascular autonomic neuropathy was assessed by standardized cardiovascular reflex tests including changes in respiratory rate variation with deep breathing , Valsalva maneuver ( Valsalva ratio ) and changes in supine to standing diastolic blood pressure .
-METHODS	Erectile dysfunction was assessed by a proxy item from the International Index of Erectile Function , and lower urinary tract symptoms were assessed with the AUASI ( American Urological Association Symptom Index ) .
-METHODS	Multivariable logistic regression models estimated the association between cardiovascular autonomic neuropathy and erectile dysfunction and/or lower urinary tract symptoms , adjusting for time weighted glycemic control , blood pressure , age and other covariates .
-RESULTS	Men in whom erectile dysfunction and/or lower urinary tract symptoms developed during EDIC had a significantly lower respiratory rate variation and Valsalva ratio at DCCT closeout and EDIC year 16/17 compared to those without erectile dysfunction or lower urinary tract symptoms .
-RESULTS	In adjusted analysis , participants with cardiovascular autonomic neuropathy had 2.65 greater odds of erectile dysfunction and lower urinary tract symptoms ( 95 % CI 1.47-4 .79 ) .
-CONCLUSIONS	These data suggest that cardiovascular autonomic neuropathy predicts the development of urological complications in men with long-standing type 1 diabetes .
-CONCLUSIONS	Studies evaluating the mechanisms contributing to these interactions are warranted for targeting effective prevention or treatment .
-
-###24664198
-BACKGROUND	Physiotherapy treatment of frozen shoulder is varied , but most lack specific focus on the underlying disorder , which is the adhered shoulder capsule .
-BACKGROUND	Although positive effects were found after physiotherapy , the recurrence and prolonged disability of a frozen shoulder are major factors to focus on to provide the appropriate treatment .
-OBJECTIVE	We wished to study the effectiveness of a shoulder countertraction apparatus on ROM , pain , and function in patients with a frozen shoulder and compare their results with those of control subjects who received conventional physiotherapy .
-METHODS	A total of 100 participants were randomly assigned to an experimental group and a control group , with each group having 50 participants .
-METHODS	The control group received physiotherapy and the experimental group received countertraction and physiotherapy .
-METHODS	The total treatment time was 20 minutes a day for 5 days per week for 2 weeks .
-METHODS	The outcome measures used were goniometer measurements , VAS , and the Oxford Shoulder Score .
-RESULTS	Improvements were seen in the scores for shoulder flexion ( 94.1 19.79 at baseline increased to 161.9 13.05 after intervention ) , abduction ROM ( 90.4 21.18 at baseline increased to 154.8 13.21 after intervention ) , and pain ( 8.00 0.78 at baseline decreased to 3.48 0.71 after intervention ) in the experimental group .
-RESULTS	Sixty percent of the participants ( n = 30 ) were improved to the fourth stage of satisfactory joint function according to the Oxford Shoulder Score in the experimental group compared with 18 % ( n = 9 ) in the control group ( p < 0.001 ) .
-CONCLUSIONS	Incorporating shoulder countertraction along with physiotherapy improves shoulder function compared with physiotherapy alone for the treatment of a frozen shoulder .
-CONCLUSIONS	Additional studies are needed focusing on this concept to increase the generalizability of the counter-traction apparatus in various groups .
-METHODS	Level II , prospective comparative study .
-METHODS	See the Instructions for Authors for a complete description of levels of evidence .
-
-###25301695
-BACKGROUND	In The Netherlands , excessive alcohol use ( e.g. , binge drinking ) is prevalent among adolescents .
-BACKGROUND	Alcohol use in general and binge drinking in particular comes with various immediate and long term health risks .
-BACKGROUND	Thus , reducing binge drinking among this target group is very important .
-BACKGROUND	This article describes a two-arm Cluster Randomized Controlled Trial ( CRCT ) of an intervention aimed at reducing binge drinking in this target group .
-METHODS	The intervention is a Web-based , computer-tailored game in which adolescents receive personalized feedback on their drinking behavior aimed at changing motivational determinants related to this behavior .
-METHODS	The development of the game is grounded in the I-Change Model .
-METHODS	A CRTC is conducted to test the effectiveness of the game .
-METHODS	Adolescents are recruited through schools , and schools are randomized into the experimental condition and the control condition .
-METHODS	The experimental condition fills in a baseline questionnaire assessing demographic variables , motivational determinants of behavior ( attitude , social influences , self-efficacy , intention ) and alcohol use .
-METHODS	They are also asked to invite their parents to take part in a short parental component that focusses on setting rules and communicating about alcohol .
-METHODS	After completing the baseline questionnaire , the experimental condition continues playing the first of three game scenarios .
-METHODS	The primary follow-up measurement takes place after four months and a second follow-up after eight months .
-METHODS	The control condition only fills in the baseline , four and eight month follow-up measurement and then receives access to the game ( i.e. , a waiting list control condition ) .
-METHODS	The effectiveness of the intervention to reduce binge drinking in the previous 30 days and alcohol use in the last week will be assessed .
-METHODS	Furthermore , intention to drink and binge drink are assessed .
-METHODS	Besides main effects , potential subgroup differences pertaining to gender , age , and educational background are explored .
-CONCLUSIONS	The study described in this article gives insight into the effectiveness of a possible solution for a prominent public health issue in The Netherlands , which is binge drinking among 16 to 18 year old adolescents .
-BACKGROUND	Dutch Trial Register ( NTR4048 ) .
-BACKGROUND	Trial registered on 06/26/2013 .
-
-###24824157
-OBJECTIVE	To compare clinical outcomes from outpatient with inpatient cervical prostaglandin E2 ripening for low risk labour induction .
-METHODS	Randomised controlled trial .
-METHODS	Two tertiary hospitals in Adelaide , Australia .
-METHODS	Women with uncomplicated term pregnancies , scheduled for induction of labour for reasons of post-dates or for social reasons .
-METHODS	Eight hundred and twenty-seven women were randomised at induction decision to an outpatient or inpatient group .
-METHODS	All women had CTG monitoring before and after vaginal PgE2 administration .
-METHODS	The inpatient women were admitted and the outpatient group was discharged home overnight with instructions to return if labour established or rupture of membranes occurred .
-METHODS	Next morning , outpatient women were admitted for rupture of membranes or further ripening .
-METHODS	After membrane rupture , both groups received routine care .
-METHODS	Oxytocin use , maternal and fetal outcomes , and whether planned outpatient management was achievable .
-RESULTS	There were no significant differences in oxytocin use ( 2.5 % difference , CI-4 .3 to 9.4 ) , caesarean sections ( -0.59 % difference , CI-6 .3 to 5.1 ) , epidural use ( 1.5 % difference , CI-5 .1 to 8.2 ) , vaginal delivery within 24 hours ( -8.2 % difference , CI-17 .6 to 1.3 ) or labour complications .
-RESULTS	More than half of the randomised women did not receive the intervention as they laboured spontaneously , or did not require ripening .
-RESULTS	The post-hoc analysis of women who received ripening also indicated no statistically significant differences in the patterns or results , with the exception of outpatient women having a longer mean length of active labour ( mean difference 66 minutes , CI 4-128 minutes ) .
-RESULTS	Outpatient women who received ripening were diagnosed more frequently with non-reassuring CTG monitoring and hyperstimulation , with less than half of the women going home and remaining home overnight .
-CONCLUSIONS	This study demonstrated no clinical advantage or disadvantage in prostaglandin E2 outpatient cervical ripening .
-CONCLUSIONS	Uterine stimulation following prostaglandins may preclude a woman from going home or remaining at home overnight and may not be the best agent for outpatient ripening .
-
-###24528648
-BACKGROUND	Microvascular alterations impair tissue oxygenation during sepsis .
-BACKGROUND	A red blood cell ( RBC ) transfusion increases oxygen ( O2 ) delivery but rarely improves tissue O2 uptake in patients with sepsis .
-BACKGROUND	Possible causes include RBC alterations due to prolonged storage or residual leukocyte-derived inflammatory mediators .
-BACKGROUND	The aim of this study was to compare the effects of two types of transfused RBCs on microcirculation in patients with sepsis .
-METHODS	In a prospective randomized trial , 20 patients with sepsis were divided into two separate groups and received either non-leukodepleted ( n = 10 ) or leukodepleted ( n = 10 ) RBC transfusions .
-METHODS	Microvascular density and perfusion were assessed with sidestream dark field ( SDF ) imaging sublingually , before and 1 hour after transfusions .
-METHODS	Thenar tissue O2 saturation ( StO2 ) and tissue hemoglobin index ( THI ) were determined with near-infrared spectroscopy , and a vascular occlusion test was performed .
-METHODS	The microcirculatory perfused boundary region was assessed in SDF images as an index of glycocalyx damage , and glycocalyx compounds ( syndecan-1 , hyaluronan , and heparan sulfate ) were measured in the serum .
-RESULTS	No differences were observed in microvascular parameters at baseline and after transfusion between the groups , except for the proportion of perfused vessels ( PPV ) and blood flow velocity , which were higher after transfusion in the leukodepleted group .
-RESULTS	Microvascular flow index in small vessels ( MFI ) and blood flow velocity exhibited different responses to transfusion between the two groups ( P = 0.03 and P = 0.04 , respectively ) , with a positive effect of leukodepleted RBCs .
-RESULTS	When within-group changes were examined , microcirculatory improvement was observed only in patients who received leukodepleted RBC transfusion as suggested by the increase in De Backer score ( P = 0.02 ) , perfused vessel density ( P = 0.04 ) , PPV ( P = 0.01 ) , and MFI ( P = 0.04 ) .
-RESULTS	Blood flow velocity decreased in the non-leukodepleted group ( P = 0.03 ) .
-RESULTS	THI and StO2 upslope increased in both groups .
-RESULTS	StO2 and StO2 downslope increased in patients who received non-leukodepleted RBC transfusions .
-RESULTS	Syndecan-1 increased after the transfusion of non-leukodepleted RBCs ( P = 0.03 ) .
-CONCLUSIONS	This study does not show a clear superiority of leukodepleted over non-leukodepleted RBC transfusions on microvascular perfusion in patients with sepsis , although it suggests a more favorable effect of leukodepleted RBCs on microcirculatory convective flow .
-CONCLUSIONS	Further studies are needed to confirm these findings .
-BACKGROUND	ClinicalTrials.gov , NCT01584999 .
-
-###25564797
-BACKGROUND	Dermal fillers have continuingly been under development to increase safety , efficacy , and longevity .
-BACKGROUND	Biostimulatory dermal fillers , such as calcium hydroxylapatite fillers , have already been shown to be superior in efficacy compared to nonanimal stabilized hyaluronic acid ( NASHA ) - based fillers .
-OBJECTIVE	In this randomized split-face study , we compared a novel biostimulatory polycaprolactone ( PCL ) - based dermal filler with a NASHA-based dermal filler , for safety , efficacy , and duration of cosmetic correction for the treatment of nasolabial folds ( NLFs ) .
-METHODS	Forty subjects received a PCL-based dermal filler in one of their NLFs , and a NASHA-based dermal filler on the contralateral side .
-METHODS	Efficacy was evaluated based on the Wrinkle Severity Rating Scale and Global Aesthetic Improvement Scale .
-RESULTS	After 6 , 9 , and 12months post-treatment , NLFs treated with the PCL-based dermal filler showed statistically significant improvements on the Wrinkle Severity Rating Scale and greater improvements on the GAIS compared to NLFs treated with the NASHA-based dermal filler .
-RESULTS	Both products were found to be equally safe and well tolerated .
-CONCLUSIONS	Our results suggest that PCL-based dermal fillers offer longer-lasting performance over NASHA-based dermal fillers in NLFs treatment .
-
-###24955812
-OBJECTIVE	A randomized , double-blind , placebo-controlled flexible-dose , parallel group trial was conducted at 26 clinical investigational sites in the United States to examine the safety and efficacy of the selegiline transdermal system ( STS ) ( EMSAM ) in adolescents ( ages 12-17 years ) meeting American Psychiatric Association , Diagnostic and Statistical Manual of Mental Disorders , 4th ed .
-OBJECTIVE	( DSM-IV ) criteria for moderate to severe major depressive disorder ( MDD ) without psychotic features .
-METHODS	Adolescents ( n = 308 ) with moderate to severe MDD were randomized to either STS ( n = 152 ) or placebo ( n = 156 ) .
-METHODS	Two hundred and fifteen ( 69.8 % ) subjects completed the study and 17 ( 5.5 % ) reported discontinuation because of adverse events ( AEs ) .
-METHODS	The primary efficacy outcome measure was the mean change from baseline to end of study ( week 12 last observation carried forward [ LOCF ] ) in the Children 's Depression Rating Scale-Revised ( CDRS-R ) total score .
-METHODS	Secondary outcome measures included end-point Clinical Global Impressions - Severity ( CGI-S ) and Clinical Global Impressions - Improvement ( CGI-I ) .
-RESULTS	Patients on STS or placebo had a significant decline from baseline ( p < 0.001 ) on their CDRS-R total score with mean reductionsSD as follows : STS 21.416.6 ; placebo 21.516.5 .
-RESULTS	Both groups had similar response rates ( 58.6 % vs. 59.3 % ) defined as CGI-I of 1 or 2 at study end .
-RESULTS	However , these between-group efficacy findings were without statistical significance .
-RESULTS	The overall incidence of reported AEs was 62.5 % for STS-treated patients and 57.7 % for placebo-treated patients .
-RESULTS	Most commonly reported AEs in STS or placebo groups were application site reactions ( STS = 24.3 % ; placebo = 21.8 % ) , headache ( STS = 17.1 % ; placebo = 16.7 % ) , and nausea ( STS = 7.2 % ; placebo = 7.7 % ) .
-RESULTS	Treatment groups did not differ on any laboratory parameters , vital signs , or electrocardiogram ( ECG ) findings .
-RESULTS	No suspected hypertensive crises were reported in the trial .
-CONCLUSIONS	These data demonstrated that the STS was safe and well tolerated in this adolescent sample .
-CONCLUSIONS	However , both STS-treated and placebo-treated subjects demonstrated a decline from baseline in depressive symptoms ( CDRS-R total score ) over the length of the study , without statistical superiority by either group .
-
-###24274799
-OBJECTIVE	Wind farm developments have been hampered by claims that sound from wind turbines causes symptoms and negative health reports in nearby residents .
-OBJECTIVE	As scientific reviews have failed to identify a plausible link between wind turbine sound and health effects , psychological expectations have been proposed as an explanation for health complaints .
-OBJECTIVE	Building on recent work showing negative expectations can create symptoms from wind turbines , we investigated whether positive expectations can produce the opposite effect , in terms of a reduction in symptoms and improvements in reported health .
-METHODS	60 participants were randomized to either positive or negative expectation groups and subsequently exposed to audible wind farm sound and infrasound .
-METHODS	Prior to exposure , negative expectation participants watched a DVD incorporating TV footage about health effects said to be caused by infrasound produced by wind turbines .
-METHODS	In contrast , positive expectation participants viewed a DVD that outlined the possible therapeutic effects of infrasound exposure .
-RESULTS	During exposure to audible windfarm sound and infrasound , symptoms and mood were strongly influenced by the type of expectations .
-RESULTS	Negative expectation participants experienced a significant increase in symptoms and a significant deterioration in mood , while positive expectation participants reported a significant decrease in symptoms and a significant improvement in mood .
-CONCLUSIONS	The study demonstrates that expectations can influence symptom and mood reports in both positive and negative directions .
-CONCLUSIONS	The results suggest that if expectations about infrasound are framed in more neutral or benign ways , then it is likely reports of symptoms or negative effects could be nullified .
-
-###24349443
-OBJECTIVE	To replicate the associations of leukocyte telomere length ( LTL ) with variants at four loci and to investigate their associations with coronary heart disease ( CHD ) and type II diabetes ( T2D ) , in order to examine possible causal effects of telomere maintenance machinery on disease aetiology .
-METHODS	Four SNPs at three loci BICD1 ( rs2630578 GC ) , 18q12 .2 ( rs2162440 GT ) , and OBFC1 ( rs10786775 CG , rs11591710 AC ) were genotyped in four studies comprised of 2353 subjects out of which 1148 had CHD and 566 T2D .
-METHODS	Three SNPs ( rs12696304 CG , rs10936601G > T and rs16847897 GC ) at the TERC locus were genotyped in these four studies , in addition to an offspring study of 765 healthy students .
-METHODS	For all samples , LTL had been measured using a real-time PCR-based method .
-RESULTS	Only one SNP was associated with a significant effect on LTL , with the minor allele G of OBFC1 rs10786775 SNP being associated with longer LTL ( = 0.029 , P = 0.04 ) .
-RESULTS	No SNPs were significantly associated with CHD or T2D .
-RESULTS	For OBFC1 the haplotype carrying both rare alleles ( rs10786775G and rs11591710C , haplotype frequency 0.089 ) was associated with lower CHD prevalence ( OR : 0.77 ; 95 % CI : 0.61-0 .97 ; P = 0.03 ) .
-RESULTS	The TERC haplotype GTC ( rs12696304G , rs10936601T and rs16847897C , haplotype frequency 0.210 ) was associated with lower risk for both CHD ( OR : 0.86 ; 95 % CI : 0.75-0 .99 ; P = 0.04 ) and T2D ( OR : 0.74 ; 95 % CI : 0.61-0 .91 ; P = 0.004 ) , with no effect on LTL .
-RESULTS	Only the last association remained after adjusting for multiple testing .
-CONCLUSIONS	Of reported associations , only that between the OBFC1 rs10786775 SNP and LTL was confirmed , although our study has a limited power to detect modest effects .
-CONCLUSIONS	A 2-SNP OBFC1 haplotype was associated with higher risk of CHD , and a 3-SNP TERC haplotype was associated with both higher risk of CHD and T2D .
-CONCLUSIONS	Further work is required to confirm these results and explore the mechanisms of these effects .
-
-###25160890
-OBJECTIVE	To examine whether older adults with vision impairment differentially benefit from cognitive speed of processing training ( SPT ) relative to healthy older adults .
-METHODS	Secondary data analyses were conducted from a randomised trial on the effects of SPT among older adults .
-METHODS	The effects of vision impairment as indicated by ( 1 ) near visual acuity , ( 2 ) contrast sensitivity , ( 3 ) self-reported cataracts and ( 4 ) self-reported other eye conditions ( e.g. , glaucoma , macular degeneration , diabetic retinopathy , optic neuritis , and retinopathy ) among participants randomised to either SPT or a social - and computer-contact control group was assessed .
-METHODS	The primary outcome was Useful Field of View Test ( UFOV ) performance .
-RESULTS	Mixed repeated-measures ancovas demonstrated that those randomized to SPT experienced greater baseline to post-test improvements in UFOV performance relative to controls ( p 's < 0.001 ) , regardless of impairments in near visual acuity , contrast sensitivity or presence of cataracts .
-RESULTS	Those with other eye conditions significantly benefitted from training ( p = 0.044 ) , but to a lesser degree than those without such conditions .
-RESULTS	Covariates included age and baseline measures of balance and depressive symptoms , which were significantly correlated with baseline UFOV performance .
-CONCLUSIONS	Among a community-based sample of older adults with and without visual impairment and eye disease , the SPT intervention was effective in enhancing participants ' UFOV performance .
-CONCLUSIONS	The analyses presented here indicate the potential for SPT to enhance UFOV performance among a community-based sample of older adults with visual impairment and potentially for some with self-reported eye disease ; further research to explore this area is warranted , particularly to determine the effects of eye diseases on SPT benefits .
-
-###24576196
-OBJECTIVE	Flu-like symptoms ( FLS ) are commonly experienced by patients receiving interferon gamma-1b which may cause discontinuation or disruption of dosing during initial therapy or on re-initiation following a break in therapy .
-OBJECTIVE	In contrast to Type I interferons , the impact of dose-titration on FLS has not been reported and is not a practice described or included in the approved prescribing information for interferon gamma-1b .
-OBJECTIVE	The objective of this study was to assess the effect of a 2 week titration regimen on the severity of FLS during the initial 3 weeks of therapy with three times weekly subcutaneous injections of interferon gamma-1b .
-METHODS	Healthy men and women were randomized into a double-blind , two-period , crossover study .
-METHODS	Each study period was 3 weeks in duration and there was a minimum 15 day washout between treatment periods .
-METHODS	Two treatment regimens were compared : No Titration dosing ( full 50mcg/m ( 2 ) subcutaneously [ s.c. ] three times weekly for 3 weeks ) and Titration ( 15mcg/m ( 2 ) s.c. three times weekly during week 1 , 30mcg/m ( 2 ) s.c. three times weekly during week 2 followed by the full dose of 50mcg/m ( 2 ) s.c. three times weekly during week 3 ) .
-METHODS	Subjects remained in the clinic for at least 12 hours following each injection .
-METHODS	FLS was based on a composite score for fever , chills , tiredness and muscle aches assessed at baseline and 4 , 8 and 12 hours following each injection .
-METHODS	Acetaminophen was allowed at the discretion of the PI .
-METHODS	The primary endpoint was the change from baseline in FLS severity at 8 hours averaged over the 3 weeks of treatment .
-METHODS	Additional endpoints included FLS at 4 and 12 hours , individual flu-like symptoms , rates of discontinuation , incidence of FLS and acetaminophen use .
-BACKGROUND	NCT 01929382 .
-RESULTS	Of the 40 subjects randomized , there were 15 ( 37.5 % ) discontinuations .
-RESULTS	Titration resulted in a significant reduction in FLS severity at 8 hours ( p = 0.023 ) averaged over the 3 week treatment period .
-RESULTS	The difference in 3 week FLS severity reflects differences during week 1 treatment , indicating an early peak in FLS severity during the No Titration treatment and subsequent development of tolerance .
-RESULTS	In contrast , titration results in near baseline severity scores throughout the treatment period .
-RESULTS	Similar trends were seen for 4 and 12 hour FLS severity scores .
-RESULTS	Of the individual FLS , difference in fever severity was most marked .
-RESULTS	Safety profiles for both regimens were consistent with the approved prescribing information for interferon gamma-1b .
-RESULTS	Study limitations included the use of healthy subjects rather than disease subjects , the lack of a validated assessment tool for evaluating FLS and the relatively high discontinuation rate .
-CONCLUSIONS	A short 2 week , dose-titration regimen reduces FLS severity following interferon gamma-1b treatment initiation in normal subjects .
-
-###24257332
-BACKGROUND	Little is known about variables associated with overdrainage complications and neurofunctional and health-related quality of life outcomes in idiopathic normal-pressure hydrocephalus ( iNPH ) patients after shunt surgery .
-OBJECTIVE	To identify candidate demographic and disease-specific predictors of overdrainage and patient-related outcomes , allowing for more personalized care of patients with iNPH .
-METHODS	This was a secondary analysis of the dataset of the SVASONA study , a multicenter randomized trial comparing gravitational and conventional gravitational valves for treating iNPH .
-METHODS	We evaluated the association between baseline items and the incidence of overdrainage , using different endpoint definitions .
-RESULTS	We identified only a few variables associated with a possible increased risk of overdrainage .
-RESULTS	Apart from using conventional rather than gravitational valves , longer duration of surgery and female sex were associated with a higher risk of clinical signs and symptoms suggestive of overdrainage ( hazard ratio : 1.02 , 95 % confidence interval : 1.01-1 .04 and 1.84 , 95 % confidence interval : 0.81-4 .16 ) .
-RESULTS	The occurrence of clinical symptoms of overdrainage , and the need for exchanging a programmable by a gravitational valve may adversely affect disease-specific outcomes like the Kiefer score .
-CONCLUSIONS	Few , if any , baseline and treatment characteristics may be helpful in estimating the individual risk of complications and clinical outcomes after shunt surgery for iNPH .
-CONCLUSIONS	Patients should be informed that longer surgery for any reason may increase the risk of later overdrainage .
-CONCLUSIONS	Also , women should be counseled about a sex-associated increased risk of the development of clinical symptoms of overdrainage , although the latter can not be distinguished from a generally higher prevalence of headaches in the female population .
-
-###25129204
-BACKGROUND	Soluble urokinase-type plasminogen activator receptor ( suPAR ) could be a causative factor in idiopathic focal segmental glomerulosclerosis ( FSGS ) .
-BACKGROUND	It is currently unknown to what extent suPAR levels could be affected by treatment with immunosuppressive drugs such as cyclosporin A ( CsA ) and mycophenolate mofetil ( MMF ) .
-BACKGROUND	Treatment with CsA , but not MMF , is accompanied by nephrotoxicity , and since suPAR levels correlate with glomerular filtration rate ( GFR ) , treatment with these drugs could indirectly modulate suPAR levels by their effect on renal function .
-METHODS	We measured suPAR levels in a recent prospective multicenter crossover trial comparing the efficacy of MMF and CsA in pediatric patients with minimal change disease ( MCD ) and frequently relapsing steroid-sensitive nephrotic syndrome ( FR-SSNS ) .
-METHODS	All patients had biopsy-proven MCD and normal renal function ; they were treated with each drug for 1 year in a crossover study design .
-METHODS	Serum suPAR levels were measured before and after 1 year of therapy with MMF ( n = 40 ) and CsA ( n = 35 ) .
-RESULTS	The suPAR levels decreased after 1 year of treatment with MMF ( p < 0.05 ) .
-RESULTS	Conversely , suPAR levels increased after 1 year of treatment with CsA in the same patients ( p = 0.01 ) .
-RESULTS	These changes in suPAR levels were not correlated to the estimated glomerular filtration rate ( eGFR ) or changes in the GFR .
-CONCLUSIONS	Data from this prospective randomized trial suggest that treatment with MMF and CsA is associated with different effects on suPAR levels in children with MCD and that these are independent of their effects on GFR .
-
-###25587059
-OBJECTIVE	To analyze choroidal thickness ( CT ) in eyes with geographic atrophy ( GA ) secondary to age-related macular degeneration ( AMD ) .
-METHODS	A total of 72 eyes of 72 patients ( mean age , 75.97 7.09 years ) with GA and 37 eyes of 37 healthy controls ( 73.89 6.19 years ) were examined by confocal scanning laser ophthalmoscopy and enhanced depth imaging ( EDI ) spectral-domain optical coherence tomography .
-METHODS	Choroidal thickness was measured at 25 defined points in horizontal and vertical scans .
-METHODS	Geographic atrophy size was determined in fundus autofluorescence ( FAF ) images and GA subtypes were classified based on abnormal FAF in the perilesional zone .
-RESULTS	In GA , subfoveal CT ( fCT ) was significantly thinner compared to controls ( 173.03 90.22 vs. 253.95 69.19 m , P < 0.001 ) .
-RESULTS	Analysis of averaged measurements of all 25 points obtained per patient ( mCT ) revealed similar results ( 162.07 76.26 vs. 228.00 66.24 m , P < 0.001 ) .
-RESULTS	Spatial differences in CT between both groups were largest superior to the fovea .
-RESULTS	Addressing `` diffuse-trickling '' ( n = 15 ) and `` non-diffuse-trickling '' ( n = 57 ) GA independently , fCT was 114.67 43.32 and 188.39 93.26 m , respectively ( P = 0.002 ) , with both groups being significantly thinner than controls ( P < 0.001 for `` diffuse-trickling '' and P < 0.001 for '' ?
-RESULTS	non-diffuse-trickling '' ) .
-RESULTS	Similar results were obtained for mCT , which was 110.21 29.66 m in `` diffuse-trickling , '' 175.72 79.02 m in '' ?
-RESULTS	non-diffuse-trickling '' and 228.00 66.24 m in controls .
-RESULTS	Differences were significant with P = 0.002 between both GA groups and P 0.001 toward controls for each GA group .
-CONCLUSIONS	The results indicate that the choroid in eyes with GA is thinner compared to normal eyes of similar age .
-CONCLUSIONS	Hereby , the extent of thinning is most pronounced in a specific subtype of GA identified by FAF imaging ( `` diffuse trickling '' ) .
-CONCLUSIONS	Such GA subtype-related differences in choroidal thickness may reflect heterogeneity in the pathogenesis of disease .
-CONCLUSIONS	( ClinicalTrials.gov number , NCT02051998 . )
-
-###24301133
-BACKGROUND	Because of the high prevalence of overweight and obesity , there is a need to identify cost-effective approaches for weight loss in primary care and community settings .
-OBJECTIVE	To evaluate the long-term cost effectiveness of a commercial weight loss programme ( Weight Watchers ) ( CP ) compared with standard care ( SC ) , as defined by national guidelines .
-METHODS	A Markov model was developed to calculate the incremental cost-effectiveness ratio ( ICER ) , expressed as the cost per quality-adjusted life year ( QALY ) over the lifetime .
-METHODS	The probabilities and quality-of-life utilities of outcomes were extrapolated from trial data using estimates from the published literature .
-METHODS	A health sector perspective was adopted .
-RESULTS	Over a patient 's lifetime , the CP resulted in an incremental cost saving of AUD 70 per patient , and an incremental 0.03 QALYs gained per patient .
-RESULTS	As such , the CP was found to be the dominant treatment , being more effective and less costly than SC ( 95 % confidence interval : dominant to 6225 per QALY ) .
-RESULTS	Despite the CP delaying the onset of diabetes by 10 months , there was no significant difference in the incidence of type 2 diabetes , with the CP achieving < 0.1 % fewer cases than SC over the lifetime .
-CONCLUSIONS	The modelled results suggest that referral to community-based interventions may provide a highly cost-effective approach for those at high risk of weight-related comorbidities .
-
-###24611590
-OBJECTIVE	This study investigates the effectiveness of Lokomat + conventional therapy in recovering walking ability in non-ambulatory subacute stroke subjects involved in inpatient rehabilitation .
-METHODS	Thirty first-ever stroke patients completed 8 weeks of intervention .
-METHODS	One group ( n = 16 ) received Lokomat therapy twice a week , combined with three times 30min a week of conventional overground therapy .
-METHODS	The second group ( n = 14 ) received conventional assisted overground therapy only , during a similar amount of time ( 3.5 h a week ) .
-METHODS	The intervention was part of the normal rehabilitation program .
-METHODS	Primary outcome measure was walking speed .
-METHODS	Secondary outcome measures assessed other walking - and mobility-related tests , lower-limb strength and quality of life measures .
-METHODS	All outcome measures were assessed before and after the intervention and at wk 24 and wk 36 after start of the intervention .
-RESULTS	Patients showed significant ( p < 0.05 ) gains in walking speed , other walking - and mobility related tests , and strength of the paretic knee extensors relative to baseline at all assessments .
-RESULTS	However , there were no significant differences in improvements in any of the variables between groups at any time during the study .
-CONCLUSIONS	These results indicate that substituting Lokomat therapy for some of conventional therapy is as effective in recovering walking ability in non-ambulatory stroke patients as conventional therapy alone .
-CONCLUSIONS	Implications for Rehabilitation Recovery of walking after stroke is important .
-CONCLUSIONS	Robot-assisted therapy is currently receiving much attention in research and rehabilitation practice as devices such as the Lokomat seem to be promising assistive devices .
-CONCLUSIONS	Technical developments , sub-optimal study designs in literature and new therapy insights warrant new effectiveness studies .
-CONCLUSIONS	RESULTS of a financially and practically feasible study indicate that substituting Lokomat therapy for some of conventional therapy is as effective in recovering walking ability in non-ambulatory stroke patients as compared to conventional overground therapy alone .
-
-###25494622
-BACKGROUND	Huntington 's disease ( HD ) is a complex , single-gene inherited neurodegenerative condition resulting in symptoms that occur across a wide range of neurological domains , including cognitive , behavioral and motor .
-BACKGROUND	The benefits of regular physical activity for people with HD are widely recognized .
-BACKGROUND	However , a number of factors can prohibit sustained exercise and activity .
-BACKGROUND	The purpose of this trial is to explore the feasibility , acceptability and effectiveness of a physical activity intervention program targeted for people with early - to mid-stage HD .
-METHODS	The proposed trial is a single blind , multisite , exploratory , randomized controlled feasibility trial of a physical activity intervention .
-METHODS	A total of 62 participants with genetically confirmed HD will be recruited .
-METHODS	Each participant will be involved in the trial for 26weeks .
-METHODS	Participants will be randomized immediately following the baseline assessment into either a physical activity intervention or a social contact control intervention .
-METHODS	The physical activity intervention is framed around self-determination theory placed within a broader behaviour change wheel framework .
-METHODS	An HD-specific workbook and individual goal setting will be utilized over six 1:1 sessions , with interim telephone calls .
-METHODS	All participants will be reassessed at 16weeks following the baseline assessment , and then again at a final follow-up assessment 26weeks later .
-METHODS	At the end of the study , all participants will be offered a brief version of the alternative intervention , with one home visit and one follow-up telephone call .
-CONCLUSIONS	Engaging and supporting people with HD in a regular physical activity program raises a number of challenges .
-CONCLUSIONS	The physical activity intervention and the comparator social interaction intervention have been developed following consultation with people with HD and their families .
-CONCLUSIONS	Each are individually tailored and determined on individual needs and goals .
-CONCLUSIONS	The results from this trial will provide guidance for the development of definitive trials .
-BACKGROUND	The trial was registered with ISRCTN ( http://www.isrctn.com/ISRCTN65378754 ) on 13 March 2014 .
-
-###25596158
-OBJECTIVE	Braces used to treat ( PF ) osteoarthritis ( OA ) may reduce contact stress across the PF joint .
-OBJECTIVE	We hypothesised that in PF OA , braces would decrease knee pain and shrink PF bone marrow lesions ( BMLs ) .
-METHODS	Eligible subjects had painful PF OA .
-METHODS	Subjects were randomly allocated to brace or no brace for 6weeks .
-METHODS	Knee MRIs were acquired at baseline and 6weeks .
-METHODS	We measured BMLs on post-contrast fat suppressed sagittal and proton density weighted axial images .
-METHODS	The primary symptom outcome was change in pain at 6weeks during a preselected painful activity , and the primary structural outcome was BML volume change in the PF joint .
-METHODS	Analyses used multiple linear regression .
-RESULTS	We randomised 126 subjects aged 40-70years ( mean age 55.5 years ; 72 females ( 57.1 % ) ) .
-RESULTS	Mean nominated visual analogue scale ( 0-10cm ) pain score at baseline was 6.5 cm .
-RESULTS	94 knees ( 75 % ) had PF BMLs at baseline .
-RESULTS	Subjects wore the brace for a mean of 7.4 h/day .
-RESULTS	6 subjects withdrew during the trial .
-RESULTS	After accounting for baseline values , the brace group had lower knee pain than the control group at 6weeks ( difference between groups -1.3 cm , 95 % CI -2.0 to -0.7 ; p < 0.001 ) and reduced PF BML volume ( difference -490.6 mm ( 3 ) , 95 % CI -929.5 to -51.7 ; p = 0.03 ) but not tibiofemoral volume ( difference -53.9 mm ( 3 ) , 95 % CI -625.9 to 518.2 ; p = 0.85 ) .
-CONCLUSIONS	A PF brace reduces BML volume in the targeted compartment of the knee , and relieves knee pain .
-BACKGROUND	UK .
-BACKGROUND	ISRCTN50380458 .
-
-###25282145
-BACKGROUND	Adjunctive psychosocial interventions are efficacious in bipolar disorder , but their incorporation into routine management plans are often confounded by cost and access constraints .
-BACKGROUND	We report here a comparative evaluation of two online programs hosted on a single website ( www.moodswings.net.au ) .
-BACKGROUND	A basic version , called MoodSwings ( MS ) , contains psychoeducation material and asynchronous discussion boards ; and a more interactive program , MoodSwings Plus ( MS-Plus ) , combined the basic psychoeducation material and discussion boards with elements of Cognitive Behavioral Therapy .
-BACKGROUND	These programs were evaluated in a head-to-head study design .
-METHODS	Participants with Bipolar I or II disorder ( n = 156 ) were randomized to receive either MoodSwings or MoodSwings-Plus .
-METHODS	Outcomes included mood symptoms , the occurrence of relapse , functionality , Locus of Control , social support , quality of life and medication adherence .
-RESULTS	Participants in both groups showed baseline to endpoint reductions in mood symptoms and improvements in functionality , quality of life and medication adherence .
-RESULTS	The MoodSwings-Plus group showed a greater number of within-group changes on symptoms and functioning in depression and mania , quality of life and social support , across both poles of the illness .
-RESULTS	MoodSwings-Plus was superior to MoodSwings in improvement on symptoms of mania scores at 12 months ( p = 0.02 ) but not on the incidence of recurrence .
-CONCLUSIONS	The study did not have an attention control group and therefore could not demonstrate efficacy of the two active arms .
-CONCLUSIONS	There was notable ( 81 % ) attrition by 12 months from baseline .
-CONCLUSIONS	This study suggests that both CBT and psychoeducation delivered online may have utility in the management of bipolar disorder .
-CONCLUSIONS	They are feasible , readily accepted , and associated with improvement .
-
-###24385639
-OBJECTIVE	To characterize change through 5-year follow-up , associated with training , booster , adherence , and other characteristics .
-METHODS	Sample included all individuals randomly assigned to reasoning training ( N = 699 ) .
-METHODS	Piecewise latent growth modeling was used to examine trajectory of performance on outcome measures .
-RESULTS	Training resulted in improved reasoning performance through Year 5 .
-RESULTS	A significant third annual booster effect was one-half the size of the training effect .
-RESULTS	Training adherence resulted in greater training effects .
-RESULTS	Higher education , Mini-Mental State Exam ( MMSE ) , better health , and younger age related to higher baseline performance .
-RESULTS	Higher MMSE was related to larger training effects , larger linear slopes , and smaller booster effects .
-RESULTS	Significant functional outcomes included a training effect for complex reaction time ( CRT ) , and first annual booster effects for the CRT and observed tasks of daily living .
-CONCLUSIONS	Initial training gain was comparable with magnitude of age-related cognitive decline over 5 years with no training .
-CONCLUSIONS	Neither age nor gender predicted training or booster effects , indicating the generality of training effects across age ( 65-90 years ) .
-
-###24636673
-OBJECTIVE	Epidemiological studies show that vascular risk factors are the same across the world but their effect vary between different race-ethnic groups .
-OBJECTIVE	However , few studies have evaluated differences in recurrent stroke rates in various race-ethnicities .
-OBJECTIVE	In > 20000 patients spanning 35 countries encompassing most race-ethnicities , we evaluated the incidence of ischemic and hemorrhagic strokes and myocardial infarction in patients within the context of the largest secondary stroke prevention trial ( Prevention Regimen for Effectively Avoiding Secondary Strokes ) to identify any significant differences .
-METHODS	There were 20332 patients with a recent ischemic stroke randomized in a factorial design to receive the antiplatelet agent clopidogrel vs. aspirin plus extended-release dipyridamole , and 80mg of the anthypertensive telmisartan vs. placebo .
-METHODS	The primary outcome for the trial was the time to any recurrent stroke .
-METHODS	Statistical analysis was used to detect race-ethnic differences in recurrent vascular events .
-RESULTS	Mean patient age was 66 ( 86 ) years and 36 % were women .
-RESULTS	The study included 58 % European/Caucasian , 33 % Asians , 5 % Latin/Hispanic , and 4 % Black African .
-RESULTS	There were 74 % of patients that were hypertensive , and average systolic and diastolic blood pressure was 1441/838mmHg .
-RESULTS	There was at least one significant difference in the overall test of all race-ethnic groups in myocardial infarction and symptomatic intracerebral hemorrhage occurrence .
-RESULTS	In the Kaplan-Meier hemorrhage and stroke-free survival curves , Asians showed a significantly higher recurrence of ischemic stroke risk in the 135-150mmHg and greater than 150mm Hg blood pressure groups , and a greater risk of hemorrhage recurrence in the greater than 150mmHg blood pressure group .
-CONCLUSIONS	We found a significant difference in myocardial infarction and symptomatic intracerebral hemorrhage recurrence among different race-ethnic groups .
-CONCLUSIONS	The risk of recurrent ischemic and hemorrhagic stroke was greater in Asians with high blood pressure .
-
-###24401049
-BACKGROUND	Whether an insulin infusion should be used for tight control of hyperglycemia in critically ill children remains unclear .
-METHODS	We randomly assigned children ( 16 years of age ) who were admitted to the pediatric intensive care unit ( ICU ) and were expected to require mechanical ventilation and vasoactive drugs for at least 12 hours to either tight glycemic control , with a target blood glucose range of 72 to 126 mg per deciliter ( 4.0 to 7.0 mmol per liter ) , or conventional glycemic control , with a target level below 216 mg per deciliter ( 12.0 mmol per liter ) .
-METHODS	The primary outcome was the number of days alive and free from mechanical ventilation at 30 days after randomization .
-METHODS	The main prespecified subgroup analysis compared children who had undergone cardiac surgery with those who had not .
-METHODS	We also assessed costs of hospital and community health services .
-RESULTS	A total of 1369 patients at 13 centers in England underwent randomization : 694 to tight glycemic control and 675 to conventional glycemic control ; 60 % had undergone cardiac surgery .
-RESULTS	The mean between-group difference in the number of days alive and free from mechanical ventilation at 30 days was 0.36 days ( 95 % confidence interval [ CI ] , -0.42 to 1.14 ) ; the effects did not differ according to subgroup .
-RESULTS	Severe hypoglycemia ( blood glucose , < 36 mg per deciliter [ 2.0 mmol per liter ] ) occurred in a higher proportion of children in the tight-glycemic-control group than in the conventional-glycemic-control group ( 7.3 % vs. 1.5 % , P < 0.001 ) .
-RESULTS	Overall , the mean 12-month costs were lower in the tight-glycemic-control group than in the conventional-glycemic-control group .
-RESULTS	The mean 12-month costs were similar in the two groups in the cardiac-surgery subgroup , but in the subgroup that had not undergone cardiac surgery , the mean cost was significantly lower in the tight-glycemic-control group than in the conventional-glycemic-control group : - $ 13,120 ( 95 % CI , - $ 24,682 to - $ 1,559 ) .
-CONCLUSIONS	This multicenter , randomized trial showed that tight glycemic control in critically ill children had no significant effect on major clinical outcomes , although the incidence of hypoglycemia was higher with tight glucose control than with conventional glucose control .
-CONCLUSIONS	( Funded by the National Institute for Health Research , Health Technology Assessment Program , U.K. National Health Service ; CHiP Current Controlled Trials number , ISRCTN61735247 . )
-
-###25256187
-OBJECTIVE	Cognitive-behavioural therapy ( CBT ) is an effective treatment for body dysmorphic disorder ( BDD ) .
-OBJECTIVE	However , most sufferers do not have access to this treatment .
-OBJECTIVE	One way to increase access to CBT is to administer treatment remotely via the Internet .
-OBJECTIVE	This study piloted a novel therapist-supported , Internet-based CBT program for BDD ( BDD-NET ) .
-METHODS	Uncontrolled clinical trial .
-METHODS	Patients ( N = 23 ) were recruited through self-referral and assessed face to face at a clinic specialising in obsessive-compulsive and related disorders .
-METHODS	Suitable patients were offered secure access to BDD-NET .
-METHODS	BDD-NET is a 12-week treatment program based on current psychological models of BDD that includes psychoeducation , functional analysis , cognitive restructuring , exposure and response prevention , and relapse prevention modules .
-METHODS	A dedicated therapist provides active guidance and feedback throughout the entire process .
-METHODS	The clinician-administered Yale-Brown Obsessive Compulsive Scale for BDD ( BDD-YBOCS ) .
-METHODS	Symptom severity was assessed pretreatment , post-treatment and at the 3-month follow-up .
-RESULTS	BDD-NET was deemed highly acceptable by patients and led to significant improvements on the BDD-YBOCS ( p = < 0.001 ) with a large within-group effect size ( Cohen 's d = 2.01 , 95 % CI 1.05 to 2.97 ) .
-RESULTS	At post-treatment , 82 % of the patients were classified as responders ( defined as30 % improvement on the BDD-YBOCS ) .
-RESULTS	These gains were maintained at the 3-month follow-up .
-RESULTS	Secondary outcome measures of depression , global functioning and quality of life also showed significant improvements with moderate to large effect sizes .
-RESULTS	On average , therapists spent 10 min per patient per week providing support .
-CONCLUSIONS	The results suggest that BDD-NET has the potential to greatly increase access to CBT , at least for low-risk individuals with moderately severe BDD symptoms and reasonably good insight .
-CONCLUSIONS	A randomised controlled trial of BDD-NET is warranted .
-BACKGROUND	Clinicaltrials.gov registration ID NCT01850433 .
-
-###24282867
-OBJECTIVE	To compare the plaque removal efficacy of a water flosser to string floss combined with a manual toothbrush after a single use .
-METHODS	Seventy adult subjects participated in this randomized , single-use , single-blind , parallel clinical study .
-METHODS	Subjects were assigned to one of two groups ; Waterpik Water Flosser plus a manual toothbrush ( WF ) or waxed string floss plus a manual toothbrush ( SF ) .
-METHODS	Each participant brushed for two minutes using the Bass technique .
-METHODS	The WF group added 500 ml of warm water to the reservoir and followed the manufacturer 's instructions , and the SF group used waxed string floss between each tooth , cleaning the mesial and distal surfaces as instructed .
-METHODS	Subjects were observed to ensure they covered all areas and followed instructions .
-METHODS	Scores were recorded for whole mouth , marginal , approximal , facial , and lingual regions for each subject using the Rustogi Modification of the Navy Plaque Index .
-RESULTS	The WF group had a 74.4 % reduction in whole mouth plaque and 81.6 % for approximal plaque compared to 57.7 % and 63.4 % for the SF group , respectively ( p < 0.001 ) .
-RESULTS	The differences between the groups showed the water flosser was 29 % more effective than string floss for overall plaque removal and approximal surfaces specifically ( p < 0.001 ) .
-RESULTS	The WF group was more effective in removing plaque from the marginal , lingual , and facial regions ; 33 % , 39 % , and 24 % , respectively ( p < 0.001 ) .
-CONCLUSIONS	The Waterpik Water Flosser and manual toothbrush is significantly more effective than a manual brush and string floss in removing plaque from tooth surfaces .
-
-###24845599
-OBJECTIVE	Test the hypotheses that tremor amplitude in musicians with task-specific dystonia is higher at the affected finger ( dystonic tremor , DT ) or the adjacent finger ( tremor associated with dystonia , TAD ) than ( 1 ) in matched fingers of healthy musicians and non-musicians and ( 2 ) within patients in the unaffected and non-adjacent fingers of the affected side within patients .
-METHODS	We measured 21 patients , 21 healthy musicians and 24 non-musicians .
-METHODS	Participants exerted a flexion-extension movement .
-METHODS	Instantaneous frequency and amplitude values were obtained with empirical mode decomposition and a Hilbert-transform , allowing to compare tremor amplitudes throughout the movement at various frequency ranges .
-RESULTS	We did not find a significant difference in tremor amplitude between patients and controls for either DT or TAD .
-RESULTS	Neither differed tremor amplitude in the within-patient comparisons .
-CONCLUSIONS	Both hypotheses were rejected and apparently neither DT nor TAD occur in musician 's dystonia of the fingers .
-CONCLUSIONS	This is the first study assessing DT and TAD in musician 's dystonia .
-CONCLUSIONS	Our finding suggests that even though MD is an excellent model for malplasticity due to excessive practice , it does not seem to provide a good model for DT .
-CONCLUSIONS	Rather it seems that musician 's dystonia may manifest itself either as dystonic cramping without tremor or as task-specific tremor without overt dystonic cramping .
-
-###24426779
-OBJECTIVE	To evaluate whether the efficacy and safety of menatetrenone for the treatment of osteoporosis is noninferior to alfacalcidol in Chinese postmenopausal women .
-METHODS	This multicenter , randomized , double-blinded , double-dummy , noninferiority , positive drug-controlled clinical trial was conducted in five Chinese sites .
-METHODS	Eligible Chinese women with postmenopausal osteoporosis ( N = 236 ) were randomized to Group M or Group A and received menatetrenone 45 mg/day or alfacalcidol 0.5 g/day , respectively , for 1 year .
-METHODS	Additionally , all patients received calcium 500 mg/day .
-METHODS	Posttreatment bone mineral density ( BMD ) , new fracture onsets , and serum osteocalcin ( OC ) and undercarboxylated OC ( ucOC ) levels were compared with the baseline value in patients of both groups .
-RESULTS	A total of 213 patients ( 90.3 % ) completed the study .
-RESULTS	After 1 year of treatment , BMD among patients in Group M significantly increased from baseline by 1.2 % and 2.7 % at the lumbar spine and trochanter , respectively ( P < 0.001 ) ; and the percentage increase of BMD in Group A was 2.2 % and 1.8 % , respectively ( P < 0.001 ) .
-RESULTS	No difference was observed between groups .
-RESULTS	There were no changes in femoral neck BMD in both groups .
-RESULTS	Two patients ( 1.9 % , 2/108 ) in Group M and four patients ( 3.8 % , 4/105 ) in Group A had new fracture onsets ( P > 0.05 ) .
-RESULTS	In Group M , OC and ucOC decreased from baseline by 38.7 % and 82.3 % , respectively ( P < 0.001 ) .
-RESULTS	In Group A , OC and ucOC decreased by 25.8 % and 34.8 % , respectively ( P < 0.001 ) .
-RESULTS	Decreases in serum OC and ucOC were more obvious in Group M than in Group A ( P < 0.001 ) .
-RESULTS	The safety profile of menatetrenone was similar to alfacalcidol .
-CONCLUSIONS	Menatetrenone is an effective and safe choice in the treatment of postmenopausal osteoporosis in Chinese women .
-
-###25107877
-OBJECTIVE	We explored the effectiveness of mirror therapy ( MT ) in the treatment of unilateral neglect in stroke patients .
-METHODS	This is an open , blinded endpoint , randomized controlled trial carried out from January 2011 to August 2013 .
-METHODS	We included stroke patients with thalamic and parietal lobe lesions with unilateral neglect 48 hours after stroke .
-METHODS	Patients were randomized to the MT group or the control group ( sham MT ) , and both the groups received limb activation .
-METHODS	Patients received treatment for 1-2 hours a day 5 days a week for 4 weeks .
-METHODS	The primary outcome was unilateral neglect assessed by a blinded assessor using the star cancellation test , the line bisection test , and a picture identification task at 1 , 3 , and 6 months .
-METHODS	This study was registered at http://clinicaltrials.gov ( NCT 01735877 ) .
-RESULTS	Forty-eight patients were randomized to MT ( n = 27 ) or the control group ( n = 21 ) .
-RESULTS	Improvement in scores on the star cancellation test over 6 months was greater in the MT group ( mean difference 23 , 95 % confidence interval [ CI ] 19-28 ; p < 0.0001 ) .
-RESULTS	Similarly , improvement in the MT group was observed in the scores on the picture identification task ( mean difference 3.2 , 95 % CI 2.4-4 .0 ; p < 0.0001 ) and line bisection test ( mean difference 8.6 , 95 % CI 2.7-14 .6 ; p = 0.006 ) .
-CONCLUSIONS	In patients with stroke , MT is a simple treatment that improves unilateral neglect .
-METHODS	This study provides Class I evidence that for patients with neglect from thalamic and parietal lobe strokes , MT improves neglect .
-
-###25191771
-BACKGROUND	In Huntington disease ( HD ) patients receiving rivastigmine treatment improvement of behavioral symptoms and of cognitive function ( assessed with screening diagnostic instruments ) has been reported .
-BACKGROUND	The aim of the present study was to verify such improvement in cognitive function by cognitive function assessment with a detailed neuropsychological battery covering all relevant cognitive systems expected to be impaired in early phase HD .
-METHODS	Eighteen ( 18 ) HD patients entered the study and were randomly allocated to the rivastigmine and placebo group .
-METHODS	All subjects underwent neuropsychological assessment at baseline .
-METHODS	Follow-up neuropsychological assessment was applied after 6 months of rivastigmine or placebo treatment .
-METHODS	Eighteen ( 18 ) healthy controls entered the study to control for practice effect and underwent neuropsychological assessment at baseline and after 6 months , without treatment .
-METHODS	The neuropsychological battery consisted of assessment tools that are sensitive to cognitive impairment seen in early phase HD : CTMT , SDMT , Stroop ( attention and information control ) , RFFT , TOL , Verbal fluency ( executive functioning ) , CVLT-II , RCFT ( learning and memory ) .
-METHODS	Effect of rivastigmine and possible effect of practice was assessed using the mixed ANOVA model .
-RESULTS	No statistically significant effect of rivastigmine treatment on cognitive function in HD patients was detected .
-RESULTS	There was no evidence for practice or placebo effect .
-CONCLUSIONS	Detailed neuropsychological assessment did not confirm previously reported effect of rivastigmine treatment on cognitive function in HD patients .
-CONCLUSIONS	The limitations of our study are , in particular , small sample size and the lack of a single measure of relevant cognitive functioning in HD patients .
-CONCLUSIONS	Instead of focusing solely on statistical significance , a clinical relevance study is proposed to clarify the issue of rivastigmine effects in HD .
-
-###24308728
-BACKGROUND	Smoking is the main preventable cause of morbidity and mortality in our region , it being the main causative agent of chronic obstructive pulmonary disease .
-BACKGROUND	There still is no consensus on the use of spirometry as a strategy for smoking cessation , given that there is insufficient scientific evidence from high quality studies to recommend the use of this technique .
-METHODS	This is to be a randomized , multicentre , open-label clinical trial .
-METHODS	A total of 444 smokers over 40 years of age will be recruited by 39 general practitioners from 22 health centers .
-METHODS	Primary objective of this study is to assess the effectiveness of spirometry together with information regarding the test for smoking cessation after 1 year in smokers over 40 years of age with a more than 10 pack-year history and no previous diagnosis of chronic obstructive pulmonary disease .
-METHODS	Groups of 45 patients who smoke will be randomly selected from the lists of the participating doctors .
-METHODS	The names will be sent to the corresponding doctors who will contact candidate patients and assess whether they meet the selection criteria .
-METHODS	Patients who meet these criteria will be randomly allocated to an intervention or control group .
-METHODS	For patients in both groups , a nurse will conduct an interview and perform a spirometry test to measure forced vital capacity .
-METHODS	Then , all patients will be referred for an appointment with their doctor for brief anti-smoking intervention , patients from the intervention group additionally being informed about the result of the spirometry test .
-METHODS	After 1 year , smoking status will be assessed and , in those who report that they have quit smoking , abstinence will be confirmed by co-oximetry .
-METHODS	Data will be analyzed on an intention-to-treat basis using the chi-squared test for outcomes and binary logistic regression if it is considered to be necessary to adjust for confounding variables .
-CONCLUSIONS	Performing a spirometry test and providing information on pulmonary function may increase awareness of the effect of smoking among smokers who are asymptomatic or have few symptoms and make them decide to quit .
-CONCLUSIONS	Specifically , in patients with chronic obstructive pulmonary disease it might increase levels of motivation to quit smoking in early stages of the disease .
-CONCLUSIONS	If this strategy were to be effective , it could be included in the health promotion activities offered in primary care .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT01821885 .
-
-###24337077
-BACKGROUND	Research is needed on initial smoking abstinence and relapse risk .
-OBJECTIVE	This study aims to investigate the effects of different durations of initial abstinence on sensitivity to smoking-related stimuli and response inhibition in the context of a larger battery of outcome measures .
-METHODS	Smokers were randomly assigned to receive payment contingent on smoking abstinence across all 15 study days ( 15C ) or just the final 2days ( 2C ) .
-METHODS	Smoking status and subject ratings were assessed daily .
-METHODS	Participants completed fMRI sessions at baseline and day 14 during which they completed craving ratings after exposure to smoking-related and neutral stimuli and performed a response inhibition task .
-METHODS	On day 15 , participants completed a smoking preference session involving 20 exclusive choices between smoking and money .
-RESULTS	The payment contingencies were effective in producing greater smoking abstinence in the 15C vs. 2C conditions .
-RESULTS	Ratings of withdrawal decreased , while ratings of ease and confidence in abstaining increased in the 15C vs. 2C conditions across the 15-day study .
-RESULTS	15C participants were less likely to choose the smoking option in the preference session .
-RESULTS	15C participants reported greater reductions in craving compared to the 2C participants in the presence of smoking-related and neutral stimuli ( i.e. , decreases in generalized craving ) , but no differences were noted in cue reactivity per se or in response inhibition .
-CONCLUSIONS	Results systematically replicate prior observations that a period 2weeks of initial abstinence decreases the relative reinforcing effects of smoking and improves other outcomes associated with relapse risk compared to the initial day or two of a cessation effort , and extends them by underscoring the importance of generalized rather than cue-induced craving in relation to relapse risk during the initial weeks of smoking cessation .
-
-###25440203
-OBJECTIVE	The aim of this study was to evaluate the clinical results of non surgical knee distraction in patients with severe knee osteoarthritis .
-METHODS	forty female patients with severe knee osteoarthritis were randomly divided in two groups .
-METHODS	A standard physiotherapy treatment was applied to both groups and in one group it was accompanied with 20 min knee joint distraction .
-METHODS	The patients were treated for 10 sessions .
-METHODS	Clinical examination consisted of functional examination , completion of a quality of life questionnaire , pain scale , and assessment of joint mobility and joint edema .
-RESULTS	The standard physiotherapy treatment accompanied by knee distraction resulted in significantly higher improvement in pain ( P = 0.004 ) , functional ability ( P = 0.02 ) , quality of life ( P = 0.002 ) and knee flexion range of motion ( p = 0.02 ) compared to the standard physiotherapy treatment alone post treatment and after 1 month follow up .
-CONCLUSIONS	Adding knee distraction to standard physiotherapy treatment can result in further improvement in pain relief , increased functional ability and better quality of life in patients with severe knee osteoarthritis .
-
-###25818798
-OBJECTIVE	To compare the efficacy of the erlotinib versus gefitinib in the first-line treatment of patients with advanced EGFR mutation-positive NSCLC .
-METHODS	Fifty patients with untreated advanced EGFR mutation - positive NSCLC were randomly divided into gefitinib group ( n = 27 ) and erlotinib group ( n = 23 ) .
-METHODS	The progression-free survival , objective response rate and disease control rate were evaluated to compare the efficacy of gefitinib and erlotinib .
-RESULTS	There were no significant differences in the objective response rate ( P = 0.711 ) and disease control rate ( P = 0.861 ) between the two groups .
-RESULTS	The progression-free survival of gefitinib group and erlotinib group was 8.0 months and 10.0 months , respectively .
-RESULTS	The efficacy of the two drugs was similar ( P = 0.293 ) .
-CONCLUSIONS	There is no significant differences between gefitinib and erlotinib in the first-line treatment of patients with advanced EGFR mutation-positive NSCLC .
-
-###24384905
-BACKGROUND	Recent research shows that advance care planning ( ACP ) for patients with chronic obstructive pulmonary disease ( COPD ) is uncommon and poorly carried out .
-BACKGROUND	The aim of the present study was to explore whether and to what extent structured ACP by a trained nurse , in collaboration with the chest physician , can improve outcomes in Dutch patients with COPD and their family .
-METHODS	A multicentre cluster randomised controlled trial in patients with COPD who are recently discharged after an exacerbation has been designed .
-METHODS	Patients will be recruited from three Dutch hospitals and will be assigned to an intervention or control group , depending on the randomisation of their chest physician .
-METHODS	Patients will be assessed at baseline and after 6 and 12 months .
-METHODS	The intervention group will receive a structured ACP session by a trained nurse .
-METHODS	The primary outcomes are quality of communication about end-of-life care , symptoms of anxiety and depression , quality of end-of-life care and quality of dying .
-METHODS	Secondary outcomes include concordance between patient 's preferences for end-of-life care and received end-of-life care , and psychological distress in bereaved family members of deceased patients .
-METHODS	Intervention and control groups will be compared using univariate analyses and clustered regression analysis .
-BACKGROUND	Ethical approval was received from the Medical Ethical Committee of the Catharina Hospital Eindhoven , the Netherlands ( NL42437 .060.12 ) .
-BACKGROUND	The current project provides recommendations for guidelines on palliative care in COPD and supports implementation of ACP in the regular clinical care .
-BACKGROUND	NTR3940 .
-
-###25823177
-OBJECTIVE	To compare the use of intralesional triamcinolone acetonide and its combination with 5 flourouracil in the treatment of keloid and hypertrophic scars in terms of reduction in initial height of the scar .
-METHODS	The randomised controlled trial was conducted at the Department of Plastic Surgery , King Edward Medical University , Lahore , from March 2011 to December 2012 .
-METHODS	It comprised patients of both genders having keloids or hypertrophic scars ( 1 cm to 5 cm in size ) having no history of treatment for the scars in preceding 6 months .
-METHODS	Those who were pregnant , planning pregnancy or lactating were excluded .
-METHODS	The subjects were divided into two groups : Group A received intralesional triamcinolone acetonide alone ; and Group B received triamcinolone acetonide + 5 flourouracil .
-METHODS	Eight injections were given at weekly interval .
-METHODS	Scars were assessed 4 weeks after the completion of treatment on a five-point scale .
-METHODS	SPSS 16 was used for statistical analysis .
-RESULTS	The 150 subjects in the study were divided into two equal groups of 75 ( 50 % ) each .
-RESULTS	Good to excellent results were seen in 51 ( 68 % ) cases in Group A compared to 63 ( 84 % ) in Group B. Frequency of complications was 18 ( 24 % ) and 6 ( 8 % ) in Group A and Group B respectively .
-CONCLUSIONS	Combination of triamcinolone acetonide and 5 flourouracil is superior to triamcinolone acetonide therapy in the treatment of keloids and hypertrophic scars .
-
-###25268398
-BACKGROUND	It is believed that local anesthetic injected to obtain circumferential spread around nerves produces a more rapid onset and successful blockade after some ultrasound-guided peripheral nerve blocks .
-BACKGROUND	However , evidence demonstrating this point is limited only to the popliteal sciatic nerve block , which is relatively easy to perform by via a high-frequency linear transducer .
-BACKGROUND	In the present study , we tested the hypothesis that multiple injections of local anesthetic to make circumferential spread would improve the rate of sensory and motor blocks compared with a single-injection technique for ultrasound-guided subgluteal sciatic nerve block , which is considered a relatively difficult block conducted with a low-frequency , curved-array transducer .
-METHODS	Ninety patients undergoing knee surgery were divided randomly into 2 groups to receive the ultrasound-guided subgluteal approach to sciatic nerve block with 20 mL of 1.5 % mepivacaine with epinephrine .
-METHODS	For group M ( the multiple-injection technique ) , the local anesthetic was injected to create circumferential spread around the sciatic nerve without limitation on the number of needle passes .
-METHODS	For group S ( the single-injection technique ) , the number of needle passes was limited to 1 , and the local anesthetic was injected to create spread along the dorsal surface of the sciatic nerve , during which no adjustment of the needle tip was made .
-METHODS	Sensory and motor blockade were assessed in double-blind fashion for 30 minutes after completion of the block .
-METHODS	The primary outcome was sensory blockade of all sciatic components tested , including tibial , superficial peroneal , and sural nerves at 30 minutes after injection .
-RESULTS	Data from 86 patients ( 43 in each group ) were analyzed .
-RESULTS	Block execution took more time for group M than group S.
-RESULTS	The proportion of patients with complete sensory blockade of all sciatic components at 30 minutes after injection was significantly larger for group M than group S ( 41.9 % vs 16.3 % , P = 0.018 ) .
-RESULTS	Complete motor blockade of foot and toes extension also was observed more frequently in group M than in group S ( 67.4 % vs 34.9 % , P = 0.005 and 51.2 % vs 25.6 % , P = 0.027 , respectively ) .
-CONCLUSIONS	When ultrasound-guided subgluteal sciatic nerve block is conducted , multiple injections of local anesthetic to make a circumferential spread around the sciatic nerve improve the rate of sensory and motor blocks compared with a single injection .
-
-###25281504
-BACKGROUND	Progressive loss of muscle and strength with age is often coincident with increases in adiposity , leading to a condition called sarcopenic obesity .
-BACKGROUND	Studies have shown sarcopenic obese adults to be at higher risk for declines in physical function .
-BACKGROUND	Despite this rising public health concern , no intervention studies currently exist in this population .
-METHODS	A total of 21 sarcopenic obese adults , 60 years or older , were randomized into two groups , strength/hypertrophy ( SH , n = 9 ) and high-speed circuit ( HSC , n = 8 ) and were trained for 15 weeks .
-METHODS	The primary outcome was the SPPB modified as a measure of physical function , assessed by assessors blinded to randomization .
-METHODS	Secondary outcomes were lower body and upper body power and strength , instrumental activities of daily living ( IADL ) , ratings of perceived exertion ( RPE ) , body fat % ( BF % ) , skeletal muscle index ( SMI ) , and grip strength ( GRP ) .
-RESULTS	For the SPPB results favored HSC over SH ( 1.1 , 95 % CI ( -.1 to 2.4 ) , p = .08 ) and showed a moderate effect size ( Hedge g = 0.6 , 95 % CI ( -0.4 , 1.6 ) ) .
-RESULTS	For secondary outcomes , lower body power ( mean difference = 158 W , 95 % CI ( 2 , 315 ) ; p = .01 ) and RPE ( mean difference = -1.5 , 95 % CI ( -2.9 , -0.12 ) ; p = .04 ) also favored HSC .
-RESULTS	IADL , SMI , BF % , upper and lower body strength and upper body power , showed no statistically significant differences between groups .
-CONCLUSIONS	Considering the moderate effect size , the large treatment effect shown by the upper limit of the 95 % CI , the low perceived exertion , and no adverse effects , HSC training should be further investigated with a larger sample size in sarcopenic obese adults .
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-###25644495
-OBJECTIVE	Septal body hypertrophy , like inferior turbinate hypertrophy , can result in changes to the nasal cross-sectional area and resistance to airflow .
-OBJECTIVE	The aim of this study is to evaluate the efficacy of septal body volume reduction ( SBVR ) for the treatment of septal body hypertrophy in patients with nasal obstruction .
-METHODS	Prospective randomized study .
-METHODS	The study was conducted on two groups ( 51 patients ) with symptoms and signs of nasal obstruction associated with septal body and inferior turbinate hypertrophy that were refractory to medical therapy .
-METHODS	In the turbinoplasty only ( ITR ) group ( n = 25 ) , conventional turbinoplasty was only performed on the inferior turbinate .
-METHODS	In the septal body reduction ( SBR ) group ( n = 26 ) , concurrent bilateral microdebrider-assisted SBVR was performed during the turbinate surgery .
-RESULTS	The nasal symptoms , including nasal obstruction , rhinorrhea , itching , and sneezing , had significantly improved at 3 months after treatment in both groups ( P < 0.001 ) .
-RESULTS	Improvement of nasal obstruction in the SBR group was greater than that in the ITR group at 3 months ( P < 0.05 ) .
-RESULTS	Acoustic rhinometry demonstrated a significant increase in the cross-sectional area and nasal volume in both groups 3 months after surgery .
-RESULTS	The postoperative change in nasal volume was higher in the SBR group ( P < 0.05 ) .
-RESULTS	No adverse reactions such as bleeding , infection , adhesions , or olfactory changes were encountered in the SBR group .
-CONCLUSIONS	Combined SBVR and turbinoplasty appears to be more effective than turbinoplasty alone for the treatment of nasal obstruction in patients with inferior turbinate and septal body hypertrophy .
-
-###25060113
-BACKGROUND	Since sugar-sweetened beverages ( SSB ) may contribute to the development of overweight in children , effective interventions to reduce their consumption are needed .
-BACKGROUND	Here we evaluated the effect of a combined school - and community-based intervention aimed at reducing children 's SSB consumption by promoting the intake of water .
-BACKGROUND	Favourable intervention effects on children 's SSB consumption were hypothesized .
-METHODS	In 2011-2012 , a controlled trial was conducted among four primary schools , comprising 1288 children aged 6-12 years who lived in multi-ethnic , socially deprived neighbourhoods in Rotterdam , the Netherlands .
-METHODS	Intervention schools adopted the ` water campaign ' , an intervention developed using social marketing .
-METHODS	Control schools continued with their regular health promotion programme .
-METHODS	Primary outcome was children 's SSB consumption , measured using parent and child questionnaires and through observations at school , both at baseline and after one year of intervention .
-RESULTS	Significant positive intervention effects were found for average SSB consumption ( B -0.19 litres , 95 % CI -0.28 ; -0.10 ; parent report ) , average SSB servings ( B -0.54 servings , 95 % CI -0.82 ; -0.26 ; parent report ) and bringing SSB to school ( OR 0.51 , 95 % CI 0.36 ; 0.72 ; observation report ) .
-CONCLUSIONS	This study supports the effectiveness of the water campaign intervention in reducing children 's SSB consumption .
-CONCLUSIONS	Further studies are needed to replicate our findings .
-BACKGROUND	Current Controlled Trials : NTR3400 .
-
-###24492904
-OBJECTIVE	Many children who lost parents in the 2008 earthquake in Sichuan Province , China , experienced symptoms of posttraumatic stress disorder ( PTSD ) and depression .
-OBJECTIVE	This randomized controlled study compared the treatment effectiveness of short-term cognitive-behavioral therapy ( CBT ) with a general supportive intervention and with a control group of nontreatment .
-OBJECTIVE	METHODS ; Thirty-two Chinese adolescents were randomly assigned to three treatment groups .
-OBJECTIVE	Participants were compared for psychological resilience ( Connor-Davidson Resilience Scale ) , symptoms of PTSD ( Children 's Revised Impact of Events Scale ) , and depression ( Center for Epidemiologic Studies Depression Scale ) at baseline , after treatment , and three-month follow-up .
-RESULTS	CBT was effective in reducing PTSD and depressive symptoms and improved psychological resilience .
-RESULTS	General support was more effective than no intervention in improving psychological resilience .
-CONCLUSIONS	Short-term CBT group intervention seems to be a robust intervention for natural disaster victims .
-CONCLUSIONS	Short-term CBT group intervention was more effective than the general supportive intervention and the no-treatment group in enhancing psychological resilience and reducing PTSD and depression among adolescents who had lost parents in the earthquake .
-CONCLUSIONS	The general supportive intervention was effective only in improving psychological resilience .
-
-###24958486
-OBJECTIVE	To assess whether bipolar transurethral resection of the prostate using the TURis ( Olympus , Tokyo , Japan ) system demonstrates comparable efficacy and safety reporting 36months of follow-up findings .
-METHODS	The trial was registered at University hospital Medical Information Network Clinical Trials Registry in Japan ( trial number UMIN 000010801 ) .
-METHODS	Patients were randomly selected to undergo transurethral resection of the prostate using either the TURis or the conventional monopolar technique .
-METHODS	Primary end points were safety according to operation time , decline of sodium and hemoglobin levels , clot retention , and catheterization time .
-METHODS	Secondary end points were efficacy findings for patients after 36months of follow-up .
-RESULTS	A total of 136 patients were enrolled .
-RESULTS	Mean operation times were significantly prolonged in the TURis group ( 68.4 and 79.5 minutes for monopolar and TURis groups , respectively ; P = .048 ) .
-RESULTS	Nosignificant differences in the decline of hemoglobin , hematocrit , and perioperative transfusion rates between groups were seen , whereas clot retention ( grade 2 ) after the treatment seemed to occur more often in the monopolar group ( 7 of 62 [ 12.3 % ] in monopolar group vs 1 of 63 [ 1/8 % ] in TURis group ; P = .061 ) .
-RESULTS	No case presented symptomatic transurethral resection syndrome in either groups .
-CONCLUSIONS	Continued efficacy at 36months after the treatment could be confirmed for the first time in TURis system , which also seems to be preferable as they produced more clinically favorable outcomes .
-CONCLUSIONS	Nevertheless , the TURis system required significantly more resection time , which might not entirely be a panacea for the treatment of benign prostatic obstruction , especially for patients having larger prostatic volumes .
-
-###24915066
-BACKGROUND	Acupuncture has been commonly used for preventing migraine attacks and relieving pain during a migraine , although there is limited knowledge on the physiological mechanism behind this method .
-BACKGROUND	The objectives of this study were to compare the differences in brain activities evoked by active acupoints and inactive acupoints and to investigate the possible correlation between clinical variables and brain responses .
-RESULTS	A randomized controlled trial and resting-state functional magnetic resonance imaging ( fMRI ) were conducted .
-RESULTS	A total of eighty migraineurs without aura were enrolled to receive either active acupoint acupuncture or inactive acupoint acupuncture treatment for 8 weeks , and twenty patients in each group were randomly selected for the fMRI scan at the end of baseline and at the end of treatment .
-RESULTS	The neuroimaging data indicated that long-term active acupoint therapy elicited a more extensive and remarkable cerebral response compared with acupuncture at inactive acupoints .
-RESULTS	Most of the regions were involved in the pain matrix , lateral pain system , medial pain system , default mode network , and cognitive components of pain processing .
-RESULTS	Correlation analysis showed that the decrease in the visual analogue scale ( VAS ) was significantly related to the increased average Regional homogeneity ( ReHo ) values in the anterior cingulate cortex in the two groups .
-RESULTS	Moreover , the decrease in the VAS was associated with increased average ReHo values in the insula which could be detected in the active acupoint group .
-CONCLUSIONS	Long-term active acupoint therapy and inactive acupoint therapy have different brain activities .
-CONCLUSIONS	We postulate that acupuncture at the active acupoint might have the potential effect of regulating some disease-affected key regions and the pain circuitry for migraine , and promote establishing psychophysical pain homeostasis .
-BACKGROUND	Chinese Clinical Trial Registry ChiCTR-TRC-13003635 .
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-###24961537
-BACKGROUND	Vegetables and fruits are rich in vitamins , minerals and , dietary fiber and contribute to the prevention and improvement of obesity and metabolic syndrome .
-BACKGROUND	However , inadequate intake of vegetable and fruit is a concern in Japan.We therefore produced a juice mixture of fresh fruit and komatsuna ( Brassica rapa L. var .
-BACKGROUND	perviridis : B. rapa ) with the aim to investigate the effects of this juice mixture on anthropometric data , blood parameters , and dietary intake differences .
-METHODS	This study was performed as a single blind and randomized controlled trial .
-METHODS	Subjects were 16 men ( mean age , 46.47.1 years ) , and they were divided into two groups ( control group and intervention group ) .
-METHODS	The intervention group consumed the juice mixture of fresh fruit and B. rapa .
-METHODS	The control group consumed commercial vegetable juice .
-METHODS	Subjects consumed juice twice a day throughout the weekday , for 4weeks .
-METHODS	We prepared both juices with an equivalent energy balance .
-RESULTS	Weight and body mass index ( BMI ) of the control group after 4weeks were significantly increased compared with baseline values .
-RESULTS	Serum total cholesterol ( T-Chol ) and low-density lipoprotein cholesterol ( LDL-Chol ) of the intervention group after 4weeks were significantly reduced compared with baseline values .
-RESULTS	Furthermore , intake of total vegetables and fruits were significantly increased compared with baseline values in both groups .
-CONCLUSIONS	Both vegetable juices contributed to improved intake of total vegetables and fruit .
-CONCLUSIONS	Compared with the intake of commercial vegetable juice , the intake of fresh fruit and B. rapa juice is highly effective in reducing serum cholesterol .
-CONCLUSIONS	Short-term intake of fresh fruit and B. rapa juice was shown to enhance cholesterol metabolism .
-
-###25047826
-BACKGROUND	Sleep deprivation from extended duty hours is a common complaint for many occupations .
-BACKGROUND	Caffeine is one of the most common countermeasures used to combat fatigue .
-BACKGROUND	However , the benefits of caffeine decline over time and with chronic use .
-OBJECTIVE	Our objective was to evaluate the efficacy of anodal transcranial direct current stimulation ( tDCS ) applied to the pre-frontal cortex at 2 mA for 30 min to remediate the effects of sleep deprivation and to compare the behavioral effects of tDCS with those of caffeine .
-METHODS	Three groups of 10 participants each received either active tDCS with placebo gum , caffeine gum with sham tDCS , or sham tDCS with placebo gum during 30 h of extended wakefulness .
-RESULTS	Our results show that tDCS prevented a decrement in vigilance and led to better subjective ratings for fatigue , drowsiness , energy , and composite mood compared to caffeine and control in sleep-deprived individuals .
-RESULTS	Both the tDCS and caffeine produced similar improvements in latencies on a short-term memory task and faster reaction times in a psychomotor task when compared to the placebo group .
-RESULTS	Interestingly , changes in accuracy for the tDCS group were not correlated to changes in mood ; whereas , there was a relationship for the caffeine and sham groups .
-CONCLUSIONS	Our data suggest that tDCS could be a useful fatigue countermeasure and may be more beneficial than caffeine since boosts in performance and mood last several hours .
-
-###25037189
-OBJECTIVE	Colonic fermentation in patients with UC in remission was compared with that in matched healthy subjects on habitual diets and when dietary fibre was increased .
-METHODS	Fibre intake , faecal output of fibre ( measured as non-starch polysaccharide ( NSP ) ) , starch , microbiota and fermentation products , and whole gut transit time ( WGTT ) were assessed in association with habitual diet and when dietary intake of wheat bran ( WB ) - associated fibre and high amylose-associated resistant starch ( RS ) was increased in an 8-week , randomised , single-blind , cross-over study .
-RESULTS	Despite a tendency to lower habitual fibre intake in UC patients , faecal NSP and starch concentrations were threefold higher than in controls , whereas concentrations of phenols and short-chain fatty acids , pH and WGTT were similar .
-RESULTS	Increasing RS/WB intake was well tolerated .
-RESULTS	In controls ( n = 10 ) , it more than doubled faecal NSP and starch excretion ( p = 0.002 for both ) , had no effect on NSP usage and reduced WGTT ( p = 0.024 ) .
-RESULTS	In UC patients ( n = 19 ) , high intake of RS/WB tended to normalise gut transit , but did not increase the proportion of NSP fermented .
-RESULTS	Increasing intake of RS/WB had little effect on faecal fermentation patterns or the structure of the microbiota .
-RESULTS	However , faeces from the UC cohort had lower proportions of Akkermansia muciniphila and increased diversity within Clostridium cluster XIVa compared to controls .
-CONCLUSIONS	Gut fermentation of NSP and starch is diminished in patients with UC .
-CONCLUSIONS	This can not be explained by abnormal gut transit and was not corrected by increasing RS/WB intake , and may be due to abnormal functioning of the gut microbiota .
-BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTRN12614000271606 .
-
-###25208688
-BACKGROUND	There have been few randomized control trials comparing the incidence of stent fracture and primary patency among different self-expanding nitinol stents to date .
-BACKGROUND	The SMART CONTROL stent ( Cordis Corp , Miami Lakes , Florida , United States ) has a peak-to-valley bridge and inline interconnection , whereas the COMPLETE-SE stent ( Medtronic Vascular , Santa Rosa , California , United States ) crowns have been configured to minimize crown-to-crown interaction , increasing the stent 's flexibility without compromising radial strength .
-BACKGROUND	Further , the 2011 ESC ( European society of cardiology ) guidelines recommend that dual antiplatelet therapy with aspirin and a thienopyridine such as clopidogrel should be administered for at least one month after infrainguinal bare metal stent implantation .
-BACKGROUND	Cilostazol has been reported to reduce intimal hyperplasia and subsequent repeat revascularization .
-BACKGROUND	To date , there has been no randomized study comparing the safety and efficacy of two different antiplatelet regimens , clopidogrel and cilostazol , following successful femoropopliteal stenting .
-METHODS	The primary purpose of our study is to examine the incidence of stent fracture and primary patency between two different major representative self-expanding nitinol stents ( SMART CONTROL versus COMPLETE-SE ) in stenotic or occlusive femoropopliteal arterial lesion .
-METHODS	The secondary purpose is to examine whether there is any difference in efficacy and safety between aspirin plus clopidogrel versus aspirin plus cilostazol for one month following stent implantation in femoropopliteal lesions .
-METHODS	This is a prospective , randomized , multicenter trial to assess the efficacy of the COMPLETE-SE versus SMART CONTROL stent for provisional stenting after balloon angioplasty in femoropopliteal arterial lesions .
-METHODS	The study design is a 2x2 randomization design and a total of 346 patients will be enrolled .
-METHODS	The primary endpoint of this study is the rate of binary restenosis in the treated segment at 12 months after intervention as determined by catheter angiography or duplex ultrasound .
-CONCLUSIONS	This trial will provide powerful insight into whether the design of the COMPLETE-SE stent is more fracture-resistant or effective in preventing restenosis compared with the SMART CONTROL stent .
-CONCLUSIONS	Also , it will determine the efficacy and safety of aspirin plus clopidogrel versus aspirin plus cilostazol in patients undergoing stent implantation in femoropopliteal lesions .
-BACKGROUND	Registered on 2 April 2012 with the National Institutes of Health Clinical Trials Registry ( ClinicalTrials.gov identifier # NCT01570803 ) .
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-###25629571
-OBJECTIVE	Entonox is a 50:50 combination of nitrous oxide and oxygen , which may be used to manage pain during colonoscopy .
-OBJECTIVE	The optimal mode of Entonox administration is unknown .
-OBJECTIVE	The aim of this study was therefore to compare continuous and as-required Entonox use .
-METHODS	Patients attending for screening colonoscopy at a single centre were randomized to continuous or as-required Entonox use .
-METHODS	The primary outcome measure was the patient 's overall pain rating at the time of discharge ( verbally administered numerical ratings scale , 0 = no pain and 10 = extreme pain ) .
-METHODS	Secondary outcome measures included the patients ' experience of pain during the colonoscopy ( rated every 2min ) , side effects and the need for rescue intravenous medications .
-RESULTS	A total of 108 patients were randomized , and 100 completed the study ( 46 continuous , 54 as required ) .
-RESULTS	The overall pain scores at discharge did not differ between those who used Entonox continuously and as required ( mean = 2.4 vs. 3.2 , P = 0.08 ) .
-RESULTS	There were also no differences in the experience of pain during colonoscopy ( mean = 1.8 vs. 2.2 , P = 0.28 ; peak = 4.2 vs. 4.8 , P = 0.26 ; and area under curve = 23 vs. 30 , P = 0.24 ) .
-RESULTS	Patients with high anxiety had greater overall pain scores ( mean = 3.7 vs. 2.4 , P = 0.03 ) .
-RESULTS	Light headedness occurred more often with continuous Entonox use ( 48 vs. 21 % , P = 0.009 ) .
-CONCLUSIONS	Among patients attending for screening colonoscopy , comfort ratings were similar in those using Entonox continuously and as required , but light headedness was more common with continuous use ( NCT identifier : 01865721 ) .
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-###25091221
-OBJECTIVE	To assess which is the optimal protocol in terms of endometrial preparation prior to frozen-thawed embryo transfer ( FET ) in women with polycystic ovarian syndrome ( PCOS ) and to explore the effect in stimulated cycle with the addition of vaginal 17 - oestradiol .
-METHODS	Five hundred and seventy-six patients with PCOS were prepared for FET using artificial cycle induced with oestradiol and progesterone supplementation ( n = 291 ) and stimulated cycle induced by human menopausal gonadotrophin ( HMG ) within or without the addition of vaginal 17 - oestradiol ( n = 285 ) .
-METHODS	Then the FET was performed in a receptive endometrium .
-RESULTS	Endometrial thickness was similar ( 9.03 1.65 vs. 9.12 1.58 , P > 0.05 ) in artificial and stimulated cycle .
-RESULTS	The two protocols resulted in clinical pregnancy rate ( 41.0 % vs. 41.6 % , P > 0.05 ) , ongoing pregnancy rate ( 36.6 % vs. 34.7 % , P > 0.05 ) , live birth rate ( 30.0 % vs. 31.7 % , P > 0.05 ) , which were not statistically different .
-RESULTS	Nevertheless , the cancelled cycle rate made a significant difference ( 2.2 % vs. 5.4 % , P < 0.05 ) .
-RESULTS	There is no significant difference in the clinical pregnancy rate in HMG , HMG added with vaginal oestradiol and HMG switch to vaginal oestradiol group ( 42.6 % , 41.1 % , and 33.3 % , respectively ) .
-CONCLUSIONS	The mean endometrial thickness , clinical pregnancy rate , ongoing pregnancy rate , live birth rate and implantation rate were similar in artificial and stimulated cycle for endometrial preparation prior to FET in PCOS .
-CONCLUSIONS	It was fine to add vaginal 17 - oestradiol to stimulated cycle when necessary .
-CONCLUSIONS	However , stimulated cycles had a significantly higher cancelled cycle rate .
-CONCLUSIONS	We should follow the principles of individualization , securitization and optimization in endometrial preparation of the FET in patients with PCOS .
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-###25061716
-OBJECTIVE	The aim of the study was to compare infants ' gastrointestinal tolerance of formulas supplemented with 2 different levels of galacto-oligosaccharides ( GOS ) versus a control formula ( CF ) or human milk .
-METHODS	Healthy , full-term infants ( n = 180 ) were enrolled in this 3-group controlled , double-blind , multicenter study , and a concurrently enrolled , nonrandomized human milk-fed group ( HM ) by 8 days of age .
-METHODS	Infants were randomized to be fed formula supplemented with either 4 g ( EF4 ) or 8 g ( EF8 ) GOS/L or a CF until day of life ( DOL ) 119 .
-METHODS	Infants were to be seen at DOL 14 , 35 , 56 , 84 , and 119 .
-METHODS	Parents were to record detailed 24-hour information about intake , tolerance to feedings , and stool patterns and consistency each day from enrollment to DOL 35 , and for 3 days before DOL 56 , 84 , and 119 .
-METHODS	Stool consistency was scored on a 5-point scale as watery ( 1 ) , loose/mushy , soft , formed , or hard ( 5 ) .
-RESULTS	The mean stool consistency score was higher in the CF group throughout the study ( CF > EF8 and CF > HM for all study periods and CF > EF4 from DOL 15 to 35 , P < 0.05 ) .
-RESULTS	There was a significantly higher percentage of watery stools in the EF8 versus the CF group from study day 1 ( SD 1 ) to DOL 14 ( P < 0.05 ) , but no differences between the groups in number of stools per day .
-RESULTS	The percentage of feedings with spit up and/or vomiting within 1 hour after feeding was significantly lower for HM versus EF8 and CF from SD 1 to DOL 14 ( P < 0.05 ) .
-CONCLUSIONS	In this clinical study , milk-based term infant formula ( Similac Advance ) with 4 g GOS/L was well-tolerated in terms of stool consistency and additional measures of gastrointestinal tolerance by newborn infants through the first 4 months of life .
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-###24654216
-BACKGROUND	Methylphenidate is a psychostimulant that has been used to relieve depressive symptoms in advanced cancer patients .
-BACKGROUND	No studies compare its efficacy against placebo in this group of patients .
-OBJECTIVE	To explore the efficacy of methylphenidate compared with placebo in the relief of depressive symptoms in advanced cancer patients .
-METHODS	A multicentre , double-blind , randomised placebo-controlled clinical trial was undertaken comparing the efficacy of methylphenidate and placebo in depressive symptoms .
-METHODS	Advanced stage cancer patients were eligible if they scored at least two points on the Two Question Screening Survey for depression .
-METHODS	A reduction of at least two points on the Edmonton Symptom Assessment Scale for depression ( 0-10 ) was considered as a response .
-RESULTS	Sixty-nine patients were included ( methylphenidate : n = 31 , placebo : n = 38 ) ; median daily dose of methylphenidate was 25 mg .
-RESULTS	Fifty-eight patients ( 84 % ) who completed the first week of treatment were considered suitable for evaluation .
-RESULTS	In the intention to treat analysis , there were 14/31 ( 45 % ) responses with methylphenidate and 10/38 ( 26 % ) responses with placebo ( difference : 19 % ; 95 % CI : 4 % to 39 % ; p = 0.10 ) .
-RESULTS	With the Hospital Anxiety and Depression Scale , 11/19 ( 58 % ) patients with methylphenidate and 10/24 ( 42 % ) with placebo improved from a score compatible with depression in the first 7 days ( difference 16 % ; 95 % CI 13 % to 42 % ; p = 0.29 ) .
-RESULTS	The proportion of patients indicating adverse effects was similar for both cohorts ( p = 0.99 ) .
-CONCLUSIONS	Compared with the placebo , methylphenidate demonstrated a positive trend in the incidence of response for depressive symptoms in advanced cancer patients .
-
-###25008127
-BACKGROUND	Depressive disorders are highly prevalent in the working population and are associated with excessive costs .
-BACKGROUND	The evidence for effective worker-directed interventions for employees with depressive symptoms is limited .
-BACKGROUND	Treating employees with depressive symptoms via the Internet before they report sick from work could be beneficial and cost saving .
-OBJECTIVE	In this study , we tested the effectiveness over the period of 1 year of a Web-based guided self-help intervention , called Happy@Work, for employees with depressive symptoms who were not on sick leave .
-METHODS	A two-arm randomized controlled trial comparing a worker-directed , Web-based , guided self-help intervention to care as usual ( CAU ) was carried out .
-METHODS	We recruited employees from 6 companies via the company 's Intranet and by putting up posters .
-METHODS	The inclusion criteria were elevated depressive symptoms as measured by a score 16 on the Center for Epidemiologic Studies Depression scale ( CES-D ) and not being on sick leave .
-METHODS	The intervention contained 6 lessons and consisted of problem-solving treatment and cognitive therapy .
-METHODS	Participants were asked to submit weekly assignments via the website after completion of a lesson and they received feedback from a coach via the website .
-METHODS	Self-report questionnaires on depressive symptoms ( CES-D ; primary outcome ) , burnout ( Maslach Burnout Inventory , MBI ) , work performance ( Health and Work Performance Questionnaire , HPQ ) , duration of absenteeism , and anxiety ( Hospital Anxiety and Depression Scale , HADS ; secondary outcomes ) , were completed at baseline , posttreatment , and at 6 - , and 12-month follow-up .
-METHODS	Several subgroup and per-protocol analyses were performed .
-RESULTS	A total of 231 employees were randomized to either the intervention group ( n = 116 ) or to CAU ( n = 115 ) .
-RESULTS	Completion of assessments varied between 54 % -74 % .
-RESULTS	Improvement in depressive symptoms between baseline and posttreatment was shown in all participants and these effects sustained over time .
-RESULTS	However , there were no differences between the 2 groups ( adjusted regression coefficient = 0.46 , 95 % CI -2.11 to 3.03 , P = .72 ; Cohen 's d = 0.05 ) .
-RESULTS	Differences between groups were also not significant for the secondary outcomes .
-RESULTS	No subgroups were identified to show differences between the groups , nor did we find a between-group effect in the per-protocol analyses .
-CONCLUSIONS	This study showed that a worker-directed , Web-based , guided self-help intervention was not more effective than CAU in reducing depressive symptoms among employees with depressive symptoms who were not on sick leave over the period of 1 year .
-CONCLUSIONS	An intervention for this specific target group might not be necessary because the recovery in the CAU group was comparable to the intervention group and sustained over a 12-month period .
-BACKGROUND	Nederlands Trial Register ( NTR ) : NTR2993 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2993 ( Archived by WebCite at http://www.webcitation.org/6PL9pFC0n ) .
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-###25465683
-OBJECTIVE	To evaluate the safety and efficacy of corneal collagen crosslinking ( CXL ) using a transepithelial technique to treat keratoconus .
-METHODS	Cornea and refractive surgery subspecialty practice .
-METHODS	Prospective clinical trial .
-METHODS	Transepithelial CXL was performed in eyes with keratoconus using proparacaine with benzalkonium chloride ( BAK ) 0.01 % to facilitate riboflavin absorption and riboflavin 0.10 % without dextran .
-METHODS	Eyes were randomized to receive ultraviolet-A treatment ( 365 nm , 3 mW/cm ( 2 ) ) with concurrent administration of riboflavin randomized to every 1 minute or every 2 minutes for 30 minutes .
-METHODS	The principal outcomes included uncorrected ( UDVA ) and corrected ( CDVA ) distance visual acuities and topography-derived maximum keratometry ( K ) values .
-METHODS	Patients were followed for 6 months .
-RESULTS	Thirty eyes of 25 patients were treated .
-RESULTS	The mean maximum K value flattened by 0.9 diopter ( D ) ( baseline 58.7 D ; 6 months 57.8 D ) ( P = .01 ) .
-RESULTS	The maximum K worsened by 2.0 D or more in 1 patient .
-RESULTS	The mean CDVA improved by 0.83 Snellen lines ( P = .03 ) .
-RESULTS	One patient lost 2 lines of CDVA .
-RESULTS	There were no differences in the UDVA , CDVA , or keratometry outcomes between the 1-minute instillation subgroup and the 2-minute instillation subgroup .
-CONCLUSIONS	Transepithelial CXL resulted in a statistically significant improvement in maximum K values and CDVA at the 6-month follow-up .
-CONCLUSIONS	Further follow-up is necessary to ascertain the ability of transepithelial CXL to achieve long-term stabilization of the cornea in eyes with keratoconus .
-
-###24235064
-BACKGROUND	Inactivity is a primary factor related to childhood obesity , yet aerobic exercise has been shown to prevent weight gain and improve fitness in adolescents .
-BACKGROUND	Moreover , children become less active during their summer break from school .
-BACKGROUND	This study compared the effects of 4 and 8 weeks of supervised summer activity versus an unsupervised summer break on metabolic function and fitness in adolescents .
-METHODS	Twenty-two adolescents were divided into 4-week ( n = 6 , weight 48.114.9 kg , body fat 27.48.4 % ) and 8-week exercise groups ( n = 6 , weight 43.410.9 kg , body fat 28.512.8 % ) , that performed supervised , play-based physical activity , versus an age-matched 8 week control group that maintained their typical summer break ( n = 10 , weight 41.710.0 kg , body fat 23.78.0 % ) .
-METHODS	Anthropometrics , resting energy expenditure ( REE ) , resting heart rate ( RHR ) and peak aerobic capacity ( VO ( 2peak ) ) were evaluated before and after the intervention ( 4 or 8 weeks ) .
-RESULTS	REE showed group differences in posttraining conditions ( the 4-week group vs. the control group , 1220169 vs. 1067144 kcal/die , and the 8-week group vs. the control group , 1202151 vs. 1067144 kcal/die , P = 0.047 ) , but RHR decreased ( pre-program vs. post program : 9722 vs. 808 beat/min , P = 0.001 ) and VO ( 2peak ) significantly increased ( pre-program vs. post program : 27.87.8 vs. 34.86.5 mL/kg/min , P = 0.001 ) in the 8-week group compared to the control group .
-CONCLUSIONS	Eight weeks of supervised play-based activity increased REE and VO ( 2peak ) in adolescents with concomitant decreases in RHR .
-CONCLUSIONS	These data suggest that this novel model of exercise prescription could be considered world-wide by clinicians to improve fitness base in adolescents and help to combat the growing epidemic of childhood obesity .
-
-###25592010
-OBJECTIVE	The aim of this study was to determine the relationship of high daily monosodium glutamate ( MSG ) consumption with glutamate concentrations in jaw muscle , saliva , and serum , and muscle pain sensitivity in healthy participants .
-METHODS	A randomized , double-blinded , placebo-controlled study was conducted to investigate the effect of repetitive consumption of high-dose MSG on glutamate concentration in the masseter muscles measured by microdialysis and muscle pain sensitivity .
-METHODS	In five contiguous experimental daily sessions , 32 healthy participants drank MSG ( 150mg/kg ) or NaCl ( 24mg/kg ) diluted with a 400mL soda .
-METHODS	The concentrations of glutamate before and after the ingestion were assessed in dialysate and plasma samples on the first and last days .
-METHODS	Saliva glutamate concentration was assessed every day .
-METHODS	Pressure pain threshold , pressure pain tolerance , autonomic parameters ( heart rate , systolic and diastolic blood pressures ) and reported side effects also were assessed .
-RESULTS	No significant change was noted in the baseline concentration of glutamate in the masseter muscle , blood , or saliva , but the peak concentration in the masseter muscle increased significantly between day 1 and 5 .
-RESULTS	A statistically significant increase in systolic and diastolic blood pressures after MSG administration was observed , as well as a significantly higher frequency of reports of nausea and headache in the MSG group .
-RESULTS	No robust effect of MSG on muscle sensitivity was found .
-CONCLUSIONS	Interstitial glutamate concentration in the masseter muscle is not highly disturbed by excessive repetitive intake of MSG in healthy man .
-
-###25275218
-OBJECTIVE	Inflammatory mediators are involved in the pathophysiology of neutrophilic bronchial disorders presenting with chronic productive cough .
-OBJECTIVE	Accumulating evidence indicates that prostanoids are key elements in the pathophysiology of these disorders .
-OBJECTIVE	However , little is known about the role of prostacyclin in neutrophilic bronchial inflammation .
-METHODS	The effect of beraprost , a chemically and biologically stable analog of prostacyclin , on cough response to inhaled capsaicin was examined in 14 patients with chronic bronchitis , a neutrophilic bronchial disorder , in a randomized , placebo-controlled crossover study .
-METHODS	Capsaicin cough threshold , defined as the lowest concentration of capsaicin eliciting five or more coughs , was measured as an index of the airway cough reflex sensitivity .
-RESULTS	After a 2-week treatment with beraprost ( 80 g twice a day orally ) , the cough threshold was significantly ( P < .05 ) decreased as compared with placebo [ 12.2 ( geometric standard error of the mean [ GSEM ] 1.5 ) M vs. 24.4 ( GSEM 1.3 ) ] .
-CONCLUSIONS	These findings indicate that prostacyclin is involved in the pathophysiology of cough reflex sensitivity in patients with chronic bronchitis , a frequently encountered neutrophilic bronchial disorder presenting with chronic productive cough .
-
-###24888915
-OBJECTIVE	The aim of this study was to compare the accuracy of placental - microglobulin-1 ( PAMG-1 ) , insulin-like growth factor binding protein-1 ( IGFBP-1 ) and nitrazine test to diagnose premature rupture of membranes .
-METHODS	A total of 120 pregnant women between 11 and 42 weeks with signs/symptoms of membrane rupture were eligible for our study .
-METHODS	These women were evaluated with the PAMG-1 , IGFBP-1 , and nitrazine tests .
-RESULTS	In the 120 women , the sensitivity , specificity , positive predictive value , and negative predictive value of PAMG-1 , IGFBP-1 and nitrazine test were 100 % , 100 % , 100 % , and 100 % , 93.33 % , 98.89 % , 96.55 % and 97.80 % , and 93.33 % , 94.44 % , 84.85 % , and 97.7 % , respectively .
-RESULTS	In a comparison of the PAMG-1 test and the nitrazine test , positive coincidence rate was 84.85 % , negative coincidence rate was 97.70 % , total coincidence rate was 94.17 % , and kappa value was 0.85 .
-RESULTS	In a comparison of the PAMG-1 test and the IGFBP-1 test , the positive coincidence rate , negative coincidence rate and total coincidence rate were 96.55 % , 97.80 % , and 97.50 % , and kappa value was 0.93 .
-CONCLUSIONS	PAMG-1 assay was the most accurate method to diagnose premature rupture of membranes with the highest sensitivity , specificity , positive predictive value and negative predictive value .
-
-###24786163
-OBJECTIVE	To evaluate the effectiveness of orally administered maropitant citrate in preventing vomiting after hydromorphone hydrochloride administration in dogs .
-METHODS	Randomized , blinded , prospective clinical study .
-METHODS	40 dogs with American Society of Anesthesiologists status of I or II , > 6 months of age , and weighing between 24 and 58.2 kg ( 52.8 and 128.04 lb ) .
-METHODS	Dogs were randomly selected to receive maropitant ( 2.0 to 4.0 mg/kg [ 0.9 to 1.8 mg/lb ] ) or placebo ( lactose monohydrate ) orally 2 hours prior to receiving hydromorphone ( 0.1 mg/kg [ 0.045 mg/lb ] , IM ) .
-METHODS	A blinded observer recorded the occurrence of vomiting or signs of nausea ( eg , salivation or lip-licking ) during a 30-minute period after hydromorphone administration .
-METHODS	Two-tailed Fisher exact tests were used to compare the incidences of vomiting and signs of nausea with or without vomiting between treatment groups .
-METHODS	Results-Of the 20 dogs receiving maropitant , none vomited but 12 ( 60 % ) developed signs of nausea .
-METHODS	Of the 20 dogs receiving placebo , 5 ( 25 % ) vomited and 11 ( 55 % ) developed signs of nausea ; overall , 16 of 20 ( 80 % ) dogs in the placebo treatment group vomited or developed signs of nausea .
-METHODS	Compared with the effects of placebo , maropitant significantly decreased the incidence of vomiting but not signs of nausea in dogs administered hydromorphone .
-CONCLUSIONS	Among the 40 study dogs , the incidence of vomiting associated with hydromorphone administration was 25 % .
-CONCLUSIONS	Oral administration of maropitant prevented vomiting but not signs of nausea associated with hydromorphone administration in dogs .
-
-###24970782
-BACKGROUND	Whether heart failure ( HF ) increases the risk of venous thromboembolism ( VTE ) is not well established .
-BACKGROUND	In the phase III MAGELLAN ( Multicenter , rAndomized , parallel Group Efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically iLL patients comparing rivaroxabAN with enoxaparin ) trial , extended-duration rivaroxaban was compared with standard-duration enoxaparin followed by placebo for VTE prevention in 8101 hospitalized acutely ill patients with or without HF .
-BACKGROUND	The aim of this analysis was to evaluate the relationship between HF severity and the risk of VTE in MAGELLAN patients .
-RESULTS	Hospitalized patients diagnosed with HF were included according to New York Heart Association class III or IV at admission ( n = 2593 ) .
-RESULTS	HF severity was determined by N-terminal probrain natriuretic peptide ( NT-proBNP ) plasma concentrations ( median 1904 pg/mL ) .
-RESULTS	Baseline plasma D-dimer concentrations ranged from 0.6 to 1.7 g/L for the less and more severe HF subgroups .
-RESULTS	Patients with more severe HF had a greater incidence of VTE versus patients with less severe HF , with a significant trend up to Day 10 ( 4.3 % versus 2.2 % ; P = 0.0108 ) and Day 35 ( 7.2 % versus 4.1 % ; P = 0.0150 ) .
-RESULTS	Multivariable analysis confirmed that NT-proBNP concentration was associated with VTE risk up to Day 10 ( P = 0.017 ) and D-dimer concentration with VTE risk up to Day 35 ( P = 0.005 ) .
-RESULTS	The association between VTE risk and HF severity that was observed in the enoxaparin/placebo group was not seen in the extended-duration rivaroxaban group .
-CONCLUSIONS	Patients with more severe HF , as defined by high NT-proBNP plasma concentration , were at increased risk of VTE .
-CONCLUSIONS	NT-proBNP may be useful to identify high short-term risk , whereas elevated D-dimer may be suggestive of high midterm risk .
-BACKGROUND	URL : http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00571649 .
-
-###24802413
-BACKGROUND	Aromatase inhibitor ( AI ) therapy results in substantial survival benefits for patients with hormone receptor-positive breast cancer .
-BACKGROUND	The rates of poor adherence and discontinuation of AI therapy are high , primarily because of treatment-related toxicities like musculoskeletal pain .
-BACKGROUND	Although pain-related symptoms may worsen during AI therapy , the authors hypothesized that nonpersistence with AI therapy was associated with symptoms that were present before treatment initiation .
-METHODS	Postmenopausal women initiating AI therapy who were enrolled in a prospective clinical trial completed questionnaires at baseline to assess sleep , fatigue , mood , and pain .
-METHODS	Reasons for treatment discontinuation during the first year of treatment were recorded .
-METHODS	Associations between baseline patient-reported symptoms and treatment discontinuation because of toxicity were identified using logistic regression .
-RESULTS	Four hundred forty-nine patients were evaluable .
-RESULTS	The odds of treatment discontinuation were higher in patients who reported a greater number of symptoms before AI initiation .
-RESULTS	Baseline poor sleep quality was associated with early treatment discontinuation , with an odds ratio ( OR ) of 1.91 ( 95 % confidence interval [ CI ] , 1.26-2 .89 ; P = .002 ) .
-RESULTS	Baseline presence of tired feeling and forgetfulness had similar ORs for discontinuation ( tired feeling : OR , 1.76 ; 95 % CI , 1.15-2 .67 ; P = .009 ; forgetfulness : OR , 1.66 ; 95 % CI , 1.11-2 .48 ; P = .015 ) .
-RESULTS	An increasing total number of baseline symptoms was associated with an increased likelihood of treatment discontinuation , with an OR of 1.89 ( 95 % CI , 1.20-2 .96 ; P = .006 ) for 3 to 5 symptoms versus 0 to 2 symptoms .
-CONCLUSIONS	Symptom clusters in breast cancer survivors that are present before the initiation of adjuvant AI therapy may have a negative impact on a patient 's persistence with therapy .
-CONCLUSIONS	Interventions to manage these symptoms may improve breast cancer outcomes and quality of life .
-
-###25040799
-BACKGROUND	Hereditary hemorrhagic telangiectasia ( HHT ) is a genetic disorder associated with abnormal angiogenesis and disabling epistaxis .
-BACKGROUND	Tranexamic acid ( TA ) has been widely used in the treatment of these severe bleeds but with no properly designed trial .
-OBJECTIVE	To demonstrate the efficacy of TA in epistaxis in HHT patients and to explore its safety of use .
-METHODS	A randomized , placebo-controlled , double-blind , cross-over trial was conducted .
-METHODS	Participants were randomized to receive TA ( 3g a day ) then placebo or the opposite sequence .
-METHODS	The main analysis compared intra-individual mean duration of epistaxis under TA vs. placebo on a log scale .
-METHODS	The primary outcome was the mean duration of epistaxis per month , assessed with specific grids to be completed by participants .
-METHODS	The number of epistaxis episodes was recorded as a secondary outcome .
-RESULTS	A total of 118 randomized patients contributed to the statistical analysis .
-RESULTS	The mean duration of epistaxis per month was significantly shorter with TA than placebo ( 0.19 on the log scale ; SD = 0.07 ; P = 0.005 ) , corresponding to a decrease of 17.3 % ( 15.7 min ) in the duration of epistaxis per month ( CI 95 % , 5.5-27 .6 ) .
-RESULTS	The median number of epistaxis episodes per month was 22.1 episodes in the placebo arm vs. 23.3 episodes in the TA arm .
-RESULTS	No thrombophlebitis was observed .
-CONCLUSIONS	In the ATERO study , we demonstrated a significant decrease in the duration of epistaxis in HHT patients taking TA .
-CONCLUSIONS	No safety issues were recorded in our cohort of patients .
-
-###24610413
-OBJECTIVE	It has been proposed that royal jelly has antioxidant properties and may improve oxidative stress and glycemic control .
-OBJECTIVE	Therefore , we investigated the effects of royal jelly supplementation in diabetic females .
-METHODS	In this pilot , parallel design randomized clinical trial , 50 female volunteers with type 2 diabetes were randomly allocated to the supplemented ( 25 , cases ) and placebo ( 25 , cases ) groups , based on random block procedure produced by Random Allocation Software , given a daily dose of 1,000 mg royal jelly soft gel or placebo , respectively , for 8 weeks .
-METHODS	Before and after intervention , glycemic control indices , antioxidant and oxidative stress factors were measured .
-RESULTS	After royal jelly supplementation , the mean fasting blood glucose decreased remarkably ( 163.0542.51 mg/dL vs. 149.6842.7 mg/dL ) .
-RESULTS	Royal jelly supplementation resulted in significant reduction in the mean serum glycosylated hemoglobin levels ( 8.67 % 2.24 % vs. 7.05 % 1.45 % , P = 0.001 ) and significant elevation in the mean insulin concentration ( 70.2829.16 pmol/L vs. 86.4627.50 pmol/L , P = 0.01 ) .
-RESULTS	Supplementation significantly increased erythrocyte superoxidase dismutase and glutathione peroxidase activities and decreased malondialdehyde levels ( P < 0.05 ) .
-RESULTS	At the end of study , the mean total antioxidant capacity elevated insignificantly in both groups .
-CONCLUSIONS	On the basis of our findings , it seems that royal jelly supplementation may be beneficial in controlling diabetes outcomes .
-CONCLUSIONS	Further studies with larger sample size are warranted .
-
-###24950987
-BACKGROUND	Evidence is scarce for the effectiveness of therapies for oesophageal cancer progressing after chemotherapy , and no randomised trials have been reported .
-BACKGROUND	We aimed to compare gefitinib with placebo in previously treated advanced oesophageal cancer .
-METHODS	For this phase 3 , parallel , randomised , placebo-controlled trial , eligible patients were adults with advanced oesophageal cancer or type I/II Siewert junctional tumours , histologically confirmed squamous-cell carcinoma or adenocarcinoma , who had progressed after chemotherapy , with WHO performance status 0-2 , and with measurable or evaluable disease on CT scan .
-METHODS	Participants were recruited from 48 UK centres and randomly assigned ( 1:1 ) to gefitinib ( 500 mg ) or matching placebo by simple randomisation with no stratification factors .
-METHODS	Patients , clinicians , and trial office staff were masked to treatment allocation .
-METHODS	Treatment continued until disease progression , unacceptable toxicity , or patient choice .
-METHODS	The primary outcome was overall survival , analysed by intention to treat .
-METHODS	This trial is registered , number ISRCTN29580179 .
-RESULTS	Between March 30 , 2009 , and Nov 18 , 2011 , 450 patients were randomly assigned to treatment groups ( one patient withdrew consent ; 224 patients allocated gefitinib and 225 allocated placebo included in analyses ) .
-RESULTS	Overall survival did not differ between groups ( median 373 months , 95 % CI 323-450 , for gefitinib vs 367 months , 95 % CI 297-437 , for placebo ; hazard ratio [ HR ] 090 , 95 % CI 074-109 , p = 029 ) .
-RESULTS	Among the prespecified patient-reported outcomes ( 110 patients on gefitinib and 121 on placebo completed both baseline and 4 week questionnaires and were included in analyses ) , odynophagia was significantly better in the gefitinib group ( adjusted mean difference -861 , 95 % CI -1449 to -273 ; n = 227 ; p = 0004 ) , whereas the other outcomes were not significantly improved compared with placebo : global quality of life ( 269 , 95 % CI -233 to 772 , n = 231 , p = 0293 ) , dysphagia ( -318 , 95 % CI -836 to 200 , n = 231 , p = 0228 ) , and eating ( -411 , 95 % CI -996 to 175 , n = 229 , p = 0168 ) .
-RESULTS	Median progression-free survival was marginally longer with gefitinib than it was with placebo ( 157 months , 95 % CI 123-190 in the gefitinib group vs 117 months , 95 % CI 107-137 in the placebo group ; HR 080 , 95 % CI 066-096 , p = 0020 ) .
-RESULTS	The most common toxicities were diarrhoea ( 36 [ 16 % ] of 224 patients on gefitinib vs six [ 3 % ] of 225 on placebo ) and skin toxicity ( 46 [ 21 % ] vs two [ 1 % ] ) , both mostly grade 2 .
-RESULTS	The commonest grade 3-4 toxicities were fatigue ( 24 [ 11 % ] vs 13 [ 6 % ] patients ) and diarrhoea ( 13 [ 6 % ] vs two [ 1 % ] ) .
-RESULTS	Serious adverse events were reported in 109 ( 49 % ) of 224 patients assigned to gefitinib and 101 ( 45 % ) of 225 on placebo .
-RESULTS	54 ( 24 % ) of patients in the gefitinib group achieved disease control at 8 weeks , as did 35 ( 16 % ) of patients on placebo ( p = 0023 ) .
-CONCLUSIONS	The use of gefitinib as a second-line treatment in oesophageal cancer in unselected patients does not improve overall survival , but has palliative benefits in a subgroup of these difficult-to-treat patients with short life expectancy .
-CONCLUSIONS	Future research should focus on identification of predictive biomarkers to identify this subgroup of benefiting patients .
-BACKGROUND	Cancer Research UK .
-
-###26054147
-OBJECTIVE	To explore the feasibility and safety on lung resection surgery with the combined method of microinjection acupuncture ( MIA ) and intravenous anesthesia instead of compound traditional acupuncture and drug anesthesia ( ADA ) .
-METHODS	Ninety cases of lung resection surgery were randomized into a general anesthesia group , a MIA group and a ADA group , 30 cases in each one .
-METHODS	In the general anesthesia group , before surgery , the intramuscular injection of atropine 0.5 mg was used ; during surgery , the anesthesia induction was followed with intravenous injection of fentanyl citrate , propofol and rocuronium bromide and the dosage was increased accordingly ; after surgery , the analgesia pump was applied .
-METHODS	In the MIA group , on the basis of general anesthesia , before anesthesia induction , the acupoint catgut embedding was applied to Jiaji ( EX-B 2 ) of T4 , T6 and T , , Feishui ( BL 13 ) , Xinshu ( BL 15 ) and Geshu ( BL 17 ) on the affected side and bilateral Quchi ( LI 11 ) and Zusanli ( ST 36 ) ; after surgery , the analgesia pump was applied .
-METHODS	In the ADA group , on the basis of general anesthesia , before !
-METHODS	anesthesia induction , electroacupuncture ( EA ) was applied to Hegu ( LI 4 ) , Neiguan ( PC 6 ) , Houxi ( SI 3 ) and Zhigou ( TE 6 ) for 30 min ; during surgery , EA and intravenous medication were combined at the same acupoints as those before surgery ; after surgery , moxibustion and the analgesia pump were applied in combination for analgesia .
-METHODS	In each group , the biological indices were monitored during surgery at 11 time points named T. ( before anesthesia I induction ) , T1 ( intubation in general anesthesia induction ) , T2 ( skin incision ) , T3 ( rib exposure in muscular incision ) T. ( chest open ) , T , ( lung removal ) , T6 ( drainage tube implantation ) , T7 ( chest closure ) , T ( muscular stitching ) , T , ( skin stitching ) and T0 ( extubation ) .
-METHODS	The actual dosage of anesthetics during surgery and the , dosage of fentanyl citrate in analgesia pump were quantified after surgery .
-METHODS	Results ( 1 ) In the MIA group and ADA group , the increased dosage of fentanyl citrate was less than that in the general anesthesia group [ ( 1.230.28 ) g .
-METHODS	kg-1 .
-METHODS	h-1 vs ( 2.40.54 g. kg-1 .
-METHODS	h-1 , ( 1.10.38 g .
-METHODS	kg-1 .
-METHODS	h-1 vs ( 2.40.54 g. kg-1 .
-METHODS	h-1 , both P < 0.05 ] .
-METHODS	The increased dosage of propofol and rocuronium bromide was not different during surgery among the groups ( all P > 0.05 ) .
-METHODS	( 2 ) In the MIA group and ADA group , after surgery , the increased dosage of fentanyl citrate was less than that in the general anesthesia group [ ( 11.01.04 ) g/kg vs ( 15.41.52 g/kg , ( 11.51.38 g/kg vs ( 15.41.52 g/kg , both P < 0.05 ] , reducing by 25 % in comparison .
-METHODS	( 3 ) The differences in heart rate and blood pressure at 11 time points during surgery were not significant among the three groups ( all P > 0.05 ) .
-CONCLUSIONS	n The combined method of MIA and intravenous anesthesia significantly reduces the dosage of intravenous anesthetics during and after lung resection surgery as compared with ADA , presenting the similar analgesic effect as simple intravenous medication and the good safety .
-CONCLUSIONS	The combined method of MIA and intravenous anesthesia is much
-
-###24821457
-BACKGROUND	A limited amount of data exists regarding the effect of lipoic acid ( LA ) , an oral antioxidant supplement , on cytokine profiles among multiple sclerosis ( MS ) patients .
-OBJECTIVE	We aimed to assess the effect of daily consumption of LA on the cytokine profiles in MS patients .
-METHODS	In this double-blind , placebo-controlled , randomized clinical trial , 52 relapsing-remitting MS patients with an age range of 18-50 years were recruited into 2 groups : LA consumption ( 1,200 mg/day ) or placebo .
-METHODS	Patients followed their prescribed supplements for 12 weeks .
-METHODS	Fasting blood samples for cytokine profile measurement were collected at baseline and after the intervention .
-METHODS	Anthropometric parameters were measured based on the standard guidelines .
-RESULTS	INF - , ICAM-1 , TGF - and IL-4 were significantly reduced in the LA group compared to the placebo group [ ( INF - : 0.82 0.2 vs. 0.2 0.2 pg/ml , p < 0.0001 ) , ( ICAM-1 : 20.2 9.4 vs. 8 10 ng/ml , p = 0.0001 ) , ( TGF - : 103.1 20.2 vs. 54.9 26 ng/ml , p < 0.0001 ) and ( IL-4 : 0.1 0.1 vs. 1.02 1.7 ng/ml , p = 0.0112 ) ] .
-RESULTS	No significant changes in TNF - , IL-6 , EDSS and MMP-9 were found between the LA and placebo groups ( p = 0.6 , p = 0.8 , p = 0.09 and p = 0.8 , respectively ) .
-CONCLUSIONS	The results suggested that consumption of 1,200 mg LA per day beneficially affects several inflammatory cytokines including INF - , ICAM-1 TGF - and IL-4 .
-CONCLUSIONS	Further investigations are needed to verify the beneficial role of LA on other cytokine profiles among MS patients .
-
-###24886107
-BACKGROUND	Evidence demonstrates that physical exercise and psychological wellbeing are closely interlinked , particularly in older-aged women .
-BACKGROUND	However , research investigating how different forms of exercise influence mental health in older-aged women is underdeveloped .
-METHODS	A randomized controlled trial ( N = 300 ) will assess the relative effectiveness of two different exercise programs ( whole-body vibration and Multicomponent Training ) for improving psychological wellbeing in older-aged women .
-METHODS	The following outcomes will be assessed at three time points ( that is , pre , post , and follow-up ) : psychological wellbeing , proactive attitude , quality of life , and happiness .
-CONCLUSIONS	Results will have important implications for preventing psychological and physiological disease in older-aged women and for managing health-related costs for this population group .
-BACKGROUND	Number NCT01966562 on Clinical Gov database the 8 October 2013 .
-
-###24445100
-OBJECTIVE	Targeted interventions to reduce the risk and increase the early detection of melanoma have the potential to save lives .
-OBJECTIVE	We aimed to assess the effect of such an intervention on patient prevention behavior .
-METHODS	We conducted a pilot clustered randomized controlled trial , comparing a targeted screening and education intervention with a conventional information-based campaign in 20 private surgeries in western France .
-METHODS	In the intervention group , 10 general practitioners identified patients at elevated risk for melanoma with a validated assessment tool , the Self-Assessment Melanoma Risk Score ( SAMScore ) , examined their skin , and counseled them using information leaflets .
-METHODS	In the control group , 10 general practitioners displayed a poster and the leaflets in their waiting room and examined patients ' skin at their own discretion .
-METHODS	The main outcome measures were sunbathing and skin self-examinations among patients at elevated risk , assessed 5 months later with a questionnaire .
-RESULTS	Analyses were based on 173 patients .
-RESULTS	Compared with control patients , intervention patients were more likely to remember the campaign ( 81.4 % vs 50.0 % , P = .0001 ) and to correctly identify their elevated risk of melanoma ( 71.1 % vs 42.1 % , P = .001 ) .
-RESULTS	Furthermore , intervention patients had higher levels of prevention behaviors : they were less likely to sunbathe in the summer ( 24.7 % vs 40.8 % , P = .048 ) and more likely to have performed skin self-examinations in the past year ( 52.6 % vs 36.8 % , P = .029 ) .
-RESULTS	The intervention was not associated with any clear adverse effects , although there were trends whereby intervention patients were more likely to worry about melanoma and to consult their general practitioner again about the disease .
-CONCLUSIONS	The combination of use of the SAMScore and general practitioner examination and counseling during consultations is an efficient way to promote patient behaviors that may reduce melanoma risk .
-CONCLUSIONS	Extending the duration of follow-up and demonstrating an impact on morbidity and mortality remain major issues for further research .
-
-###24289597
-OBJECTIVE	To compare the effectiveness of different methods of recall for repeat Pap smear among women who had normal smears in the previous screening .
-METHODS	Prospective randomized controlled study .
-METHODS	All community clinics in Klang under the Ministry of Health Malaysia .
-METHODS	Women of Klang who attended cervical screening and had a normal Pap smear in the previous year , and were due for a repeat smear were recruited and randomly assigned to four different methods of recall for repeat smear .
-METHODS	The recall methods given to the women to remind them for a repeat smear were either by postal letter , registered letter , short message by phone ( SMS ) or phone call .
-METHODS	Number and percentage of women who responded to the recall within 8 weeks after they had received the recall , irrespective whether they had Pap test conducted .
-METHODS	Also the numbers of women in each recall method that came for repeat Pap smear .
-RESULTS	The rates of recall messages reaching the women when using letter , registered letter , SMS and phone calls were 79 % , 87 % , 66 % and 68 % , respectively .
-RESULTS	However , the positive responses to recall by letter , registered letter , phone messages and telephone call were 23.9 % , 23.0 % , 32.9 % and 50.9 % , respectively ( p < 0.05 ) .
-RESULTS	Furthermore , more women who received recall by phone call had been screened ( p < 0.05 ) compared to those who received recall by postal letter ( OR = 2.38 , CI = 1.56-3 .62 ) .
-CONCLUSIONS	Both the usual way of sending letters and registered letters had higher chances of reaching patients compared to using phone either for sending messages or calling .
-CONCLUSIONS	The response to the recall method and uptake of repeat smear , however , were highest via phone call , indicating the importance of direct communication .
-
-###24329568
-OBJECTIVE	When cats purr during examination it is difficult to perform auscultation .
-OBJECTIVE	The objective of this study was to determine the prevalence of purring in cats during examination , and identify interventions that could be used to stop purring .
-METHODS	Cats seen at a first opinion clinic were enrolled in the study and their purring status recorded .
-METHODS	Thirty of the purring cats were exposed to up to three different interventions in an attempt to stop purring in a randomised controlled trial including blowing at the ear , use of an ethanol-based aerosol near the cat and proximity to a running tap .
-RESULTS	The 30 cats in the trial were subjected to a total of 54 attempts to stop purring , proximity to a running tap caused 17 of 21 ( 81 % ) cats to stop purring , blowing at the cat 's ears worked in 2 of 15 ( 13 % ) cats , spraying an aerosol close to the cat was effective in 9 of 18 ( 50 % ) cases .
-RESULTS	In 2 cats ( 7 % ) , none of the interventions interrupted purring .
-CONCLUSIONS	This study provides evidence that placing a purring cat near a running tap and in proximity to the discharge of an ethanol-based aerosol are effective measures to stop purring in order to allow auscultation .
-
-###25645108
-OBJECTIVE	To evaluate the safety of the concurrent combination of bevacizumab with adjuvant radiotherapy ( B-RT ) in breast cancer ( BC ) .
-METHODS	Multicentre , prospective study , of the toxicity of adjuvant radiotherapy ( RT ) alone or B-RT in patients with non-metastatic BC enrolled in randomized Phase 3 BEATRICE trial .
-METHODS	Early and late toxicities were assessed by the Common Terminology Criteria for Adverse Events v. 3.0 during and 12 months after the completion of RT. .
-RESULTS	From 2007 to 2012 , 39 females received adjuvant B-RT and 45 received adjuvant RT alone .
-RESULTS	Median follow-up was 21.5 months .
-RESULTS	All patients had triple-negative non-metastatic BC and received adjuvant chemotherapy followed by RT. 90 % of the 39 females treated by concurrent B-RT received whole breast irradiation ( WBI ) with a boost and 4 ( 10 % ) received post-mastectomy RT. .
-RESULTS	Lymph node RT was delivered in 49 % of the females with internal mammary chain irradiation .
-RESULTS	The mean duration of bevacizumab was 11.7 months .
-RESULTS	38 ( 84 % ) females treated by RT alone received WBI with a boost and 16 % of the females received post-mastectomy RT. .
-RESULTS	Lymph node RT was delivered in 47 % of the females with internal mammary chain RT in 31 % .
-RESULTS	Grade 3 acute dermatitis was observed in 9 % of patients receiving B-RT and 5 % of patients receiving RT alone with no significant difference .
-RESULTS	1 year after the completion of RT , the most common late grade 1-2 toxicities in the B-RT group were pain ( 18 % ) , fibrosis ( 8 % ) and telangiectasia ( 5 % ) .
-CONCLUSIONS	The concurrent bevacizumab with locoregional RT is associated with acceptable early and late 1-year toxicities in patients with BC .
-CONCLUSIONS	The largest series of this association .
-
-###24608079
-OBJECTIVE	To determine the efficacy and toxicity of higher dose versus standard dose intravenous methotrexate ( MTX ) and pulses of high-dose cytosine arabinoside with asparaginase versus standard dose cytosine arabinoside and teniposide during intensified continuation therapy for higher risk pediatric B-precursor acute lymphoblastic leukemia ( ALL ) .
-METHODS	From 1994 to 1999 , the Pediatric Oncology Group conducted a randomized phase III clinical trial in higher risk pediatric B-precursor ALL .
-METHODS	A total of 784 patients were randomized in a 22 factorial design to receive MTX 1 g/m versus 2.5 g/m and to cytosine arabinoside/teniposide versus high-dose cytosine arabinoside/asparaginase during intensified continuation therapy .
-RESULTS	Patients receiving standard dose MTX had a 5-year disease-free survival ( DFS ) of 71.82.4 % ; patients receiving higher dose MTX had a 5-year DFS of 71.72.4 % ( P = 0.55 ) .
-RESULTS	Outcomes on cytosine arabinoside/teniposide ( DFS of 70.42.4 ) were similar to higher dose cytosine arabinoside/asparaginase ( DFS of 73.12.3 % ) ( P = 0.41 ) .
-RESULTS	Overall survival rates were not different between MTX doses or cytosine arabinoside/teniposide versus cytosine arabinoside/asparaginase .
-CONCLUSIONS	Increasing MTX dosing to 2.5 g/m did not improve outcomes in higher risk pediatric B-precursor ALL .
-CONCLUSIONS	Giving high-dose cytarabine and asparaginase pulses instead of standard dose cytarabine and teniposide produced nonsignificant differences in outcomes , allowing for teniposide to be removed from ALL therapy .
-
-###26142578
-OBJECTIVE	To evaluate how a genomic classifier ( GC ) that predicts the risk of metastasis after prostatectomy would impact adjuvant treatment recommendations made by radiation oncologists and urologists .
-OBJECTIVE	The 2 specialties often disagree about postprostatectomy adjuvant treatment recommendations .
-METHODS	Twenty-six radiation oncologists and 20 urologists with genitourinary oncology expertise reviewed de-identified clinical results from 11 patients after radical prostatectomy and made adjuvant treatment recommendations .
-METHODS	The same cases were later randomized and reassigned , and treatment recommendations were made using the clinical information and GC test results together .
-RESULTS	Using clinical information alone , observation was recommended in 42 % of decisions made by urologists vs 23 % by radiation oncologists ( P < .0001 ) .
-RESULTS	The GC test results altered 35 % and 45 % of treatment recommendations made by radiation oncologists and urologists , respectively .
-RESULTS	Multivariate analysis showed GC risk was the strongest factor influencing treatment recommendations by both specialties , with an adjusted odds ratio of 4.17 ( 95 % confidence interval [ CI ] , 2.26-7 .70 ) and 6.51 ( 95 % CI , 4.29-9 .88 ) for radiation oncologists and urologists , respectively .
-RESULTS	GC results indicating high metastatic risk resulted in intensification of treatment , whereas low metastatic risk resulted in less aggressive recommendations .
-RESULTS	The GC results increased interdisciplinary agreement in treatment recommendations , as the odds of a recommendation for adjuvant treatment by urologists vs radiation oncologists increased from 0.27 ( 95 % CI , 0.17-0 .44 ) to 0.46 ( 95 % CI , 0.29-0 .75 ) after results of the GC test were available .
-CONCLUSIONS	The GC test significantly influenced adjuvant postprostatectomy treatment recommendations , reduced disagreement between radiation oncologists and urologists , and has the potential to enhance personalization of postprostatectomy care .
-
-###26488693
-BACKGROUND	Nonmelanoma skin cancers , such as basal-cell carcinoma and squamous-cell carcinoma , are common cancers that are caused principally by ultraviolet ( UV ) radiation .
-BACKGROUND	Nicotinamide ( vitamin B3 ) has been shown to have protective effects against damage caused by UV radiation and to reduce the rate of new premalignant actinic keratoses .
-METHODS	In this phase 3 , double-blind , randomized , controlled trial , we randomly assigned , in a 1:1 ratio , 386 participants who had had at least two nonmelanoma skin cancers in the previous 5 years to receive 500 mg of nicotinamide twice daily or placebo for 12 months .
-METHODS	Participants were evaluated by dermatologists at 3-month intervals for 18 months .
-METHODS	The primary end point was the number of new nonmelanoma skin cancers ( i.e. , basal-cell carcinomas plus squamous-cell carcinomas ) during the 12-month intervention period .
-METHODS	Secondary end points included the number of new squamous-cell carcinomas and basal-cell carcinomas and the number of actinic keratoses during the 12-month intervention period , the number of nonmelanoma skin cancers in the 6-month postintervention period , and the safety of nicotinamide .
-RESULTS	At 12 months , the rate of new nonmelanoma skin cancers was lower by 23 % ( 95 % confidence interval [ CI ] , 4 to 38 ) in the nicotinamide group than in the placebo group ( P = 0.02 ) .
-RESULTS	Similar differences were found between the nicotinamide group and the placebo group with respect to new basal-cell carcinomas ( 20 % [ 95 % CI , -6 to 39 ] lower rate with nicotinamide , P = 0.12 ) and new squamous-cell carcinomas ( 30 % [ 95 % CI , 0 to 51 ] lower rate , P = 0.05 ) .
-RESULTS	The number of actinic keratoses was 11 % lower in the nicotinamide group than in the placebo group at 3 months ( P = 0.01 ) , 14 % lower at 6 months ( P < 0.001 ) , 20 % lower at 9 months ( P < 0.001 ) , and 13 % lower at 12 months ( P = 0.001 ) .
-RESULTS	No noteworthy between-group differences were found with respect to the number or types of adverse events during the 12-month intervention period , and there was no evidence of benefit after nicotinamide was discontinued .
-CONCLUSIONS	Oral nicotinamide was safe and effective in reducing the rates of new nonmelanoma skin cancers and actinic keratoses in high-risk patients .
-CONCLUSIONS	( Funded by the National Health and Medical Research Council ; ONTRAC Australian New Zealand Clinical Trials Registry number , ACTRN12612000625875 . )
-
-###26348751
-OBJECTIVE	Anemia affects most pregnant African women and is predominantly due to iron deficiency , but antenatal iron supplementation has uncertain health benefits and can increase the malaria burden .
-OBJECTIVE	To measure the effect of antenatal iron supplementation on maternal Plasmodium infection risk , maternal iron status , and neonatal outcomes .
-METHODS	Randomized placebo-controlled trial conducted October 2011 through April 2013 in a malaria endemic area among 470 rural Kenyan women aged 15 to 45 years with singleton pregnancies , gestational age of 13 to 23 weeks , and hemoglobin concentration of 9 g/dL or greater .
-METHODS	All women received 5.7 mg iron/day through flour fortification during intervention , and usual intermittent preventive treatment against malaria was given .
-METHODS	Supervised daily supplementation with 60 mg of elemental iron ( as ferrous fumarate , n = 237 women ) or placebo ( n = 233 ) from randomization until 1 month postpartum .
-METHODS	Primary outcome was maternal Plasmodium infection at birth .
-METHODS	Predefined secondary outcomes were birth weight and gestational age at delivery , intrauterine growth , and maternal and infant iron status at 1 month after birth .
-RESULTS	Among the 470 participating women , 40 women ( 22 iron , 18 placebo ) were lost to follow-up or excluded at birth ; 12 mothers were lost to follow-up postpartum ( 5 iron , 7 placebo ) .
-RESULTS	At baseline , 190 of 318 women ( 59.7 % ) were iron-deficient .
-RESULTS	In intention-to-treat analysis , comparison of women who received iron vs placebo , respectively , yielded the following results at birth : Plasmodium infection risk : 50.9 % vs 52.1 % ( crude difference , -1.2 % , 95 % CI , -11.8 % to 9.5 % ; P = .83 ) ; birth weight : 3202 g vs 3053 g ( crude difference , 150 g , 95 % CI , 56 to 244 ; P = .002 ) ; birth-weight-for-gestational-age z score : 0.52 vs 0.31 ( crude difference , 0.21 , 95 % CI , -0.11 to 0.52 ; P = .20 ) ; and at 1 month after birth : maternal hemoglobin concentration : 12.89 g/dL vs 11.99 g/dL ( crude difference , 0.90 g/dL , 95 % CI , 0.61 to 1.19 ; P < .001 ) ; geometric mean maternal plasma ferritin concentration : 32.1 g/L vs 14.4 g/L ( crude difference , 123.4 % , 95 % CI , 85.5 % to 169.1 % ; P < .001 ) ; geometric mean neonatal plasma ferritin concentration : 163.0 g/L vs 138.7 g/L ( crude difference , 17.5 % , 95 % CI , 2.4 % to 34.8 % ; P = .02 ) .
-RESULTS	Serious adverse events were reported for 9 and 12 women who received iron and placebo , respectively .
-RESULTS	There was no evidence that intervention effects on Plasmodium infection risk were modified by intermittent preventive treatment use .
-CONCLUSIONS	Among rural Kenyan women with singleton pregnancies , administration of daily iron supplementation , compared with administration of placebo , resulted in no significant differences in overall maternal Plasmodium infection risk .
-CONCLUSIONS	Iron supplementation led to increased birth weight .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01308112 .
-
-###24451290
-OBJECTIVE	The recent Danish Multicentre Randomized Trial on Single-Lead Atrial ( AAIR ) Pacing versus Dual-Chamber ( DDDR ) Pacing in Sick Sinus Syndrome ( DANPACE ) suggested DDDR pacing as standard care .
-OBJECTIVE	However , previous findings supported the routine use of AAIR pacing .
-OBJECTIVE	This study investigated the cost-effectiveness of DDDR pacing compared with AAIR pacing for sick sinus syndrome .
-RESULTS	A decision-analytical model based on patient-level data from three randomized trials was designed from the Danish healthcare system 's perspective .
-RESULTS	The main outcomes were lifetime costs , quality-adjusted lifeyears ( QALYs ) , and net monetary benefit .
-RESULTS	Quality-adjusted lifeyears were calculated by utilizing community-based preferences .
-RESULTS	Costs were calculated by utilizing the extensive data on resource consumption , from the DANPACE trial .
-RESULTS	Data were pooled and adjusted for baseline differences .
-RESULTS	Dual-chamber pacing was shown to be cost-effective in all the analyses using a willingness-to-pay ( WTP ) threshold of 20,000 / QALY , and most analyses using a WTP of 30,000 / QALY .
-RESULTS	When pooling the data and adjusting for baseline differences , Monte Carlo simulations revealed a 51-71 % probability of DDDR pacing being cost-effective at a WTP of 20,000 / QALY , and a 42-58 % probability at a WTP of 30,000 / QALY .
-RESULTS	Dual-chamber pacing was most likely to be cost-effective among elderly patients with comorbidity .
-RESULTS	The expected value of perfect information was low and initiation of additional publicly funded Danish trials was discouraged .
-CONCLUSIONS	Dual-chamber pacing is likely to be a cost-effective treatment for sick sinus syndrome patients .
-
-###24305085
-BACKGROUND	This study looks at the effect of immediate session-by-session feedback using short questionnaires for evaluating outcome of and alliance in the therapy .
-BACKGROUND	Research data strongly suggests that using this feedback informed treatment improves the outcome of therapy .
-BACKGROUND	However , until now , this method of Miller and Duncan has only been examined in clients ( generally students ) with mild problems and in partner counselling .
-BACKGROUND	The question addressed by this study is whether immediate feedback is also effective when applied during crisis intervention and subsequent brief therapy in a psychiatric patient population in emergency situations .
-BACKGROUND	It also looks at whether ` feedback-informed treatment ' affects the quality of the alliance .
-METHODS	To test the hypotheses , all patients seeking help from the Crisis Intervention & Brief Therapy Team over a two-year period will be followed throughout their treatment up to a maximum of six months and a follow-up period of three months after ending the treatment .
-METHODS	Patients are randomly assigned to two conditions : treatment without feedback and treatment with immediate feedback for each session .
-METHODS	The therapists all operate in both conditions and so they deliver both treatments .
-METHODS	An estimated total of 180 patients , aged 18years and over , will be included in the study .
-CONCLUSIONS	The aim of this study is to make clear whether , and to what extent , systematic feedback from the patient in this target group during therapy determines the course and outcomes of therapy .
-CONCLUSIONS	We also look at whether , and to what extent , the quality of the alliance and the motivation of the person delivering treatment with respect to the instruments play a role .
-BACKGROUND	NTR3168 .
-
-###25670541
-OBJECTIVE	To report the long-term results of the ARO 95-06 randomized trial comparing hyperfractionated accelerated chemoradiation with mitomycin C/5-fluorouracil ( C-HART ) with hyperfractionated accelerated radiation therapy ( HART ) alone in locally advanced head and neck cancer .
-METHODS	The primary endpoint was locoregional control ( LRC ) .
-METHODS	Three hundred eighty-four patients with stage III ( 6 % ) and IV ( 94 % ) oropharyngeal ( 59.4 % ) , hypopharyngeal ( 32.3 % ) , and oral cavity ( 8.3 % ) cancer were randomly assigned to 30Gy/2Gy daily followed by twice-daily 1.4 Gy to a total of 70.6 Gy concurrently with mitomycin C/5-FU ( C-HART ) or 16Gy/2Gy daily followed by twice-daily 1.4 Gy to a total dose of 77.6 Gy alone ( HART ) .
-METHODS	Statistical analyses were done with the log-rank test and univariate and multivariate Cox regression analyses .
-RESULTS	The median follow-up time was 8.7 years ( 95 % confidence interval [ CI ] : 7.8-9 .7 years ) .
-RESULTS	At 10years , the LRC rates were 38.0 % ( C-HART ) versus 26.0 % ( HART , P = .002 ) .
-RESULTS	The cancer-specific survival and overall survival rates were 39 % and 10 % ( C-HART ) versus 30.0 % and 9 % ( HART , P = .042 and P = .049 ) , respectively .
-RESULTS	According to multivariate Cox regression analysis , the combined treatment was associated with improved LRC ( hazard ratio [ HR ] : 0.6 [ 95 % CI : 0.5-0 .8 ; P = .002 ] ) .
-RESULTS	The association between combined treatment arm and increased LRC appeared to be limited to oropharyngeal cancer ( P = .003 ) as compared with hypopharyngeal or oral cavity cancer ( P = .264 ) .
-CONCLUSIONS	C-HART remains superior to HART in terms of LRC .
-CONCLUSIONS	However , this effect may be limited to oropharyngeal cancer patients .
-
-###24917531
-OBJECTIVE	To compare the rates of urinary incontinence ( UI ) and other complications of subtotal abdominal hysterectomy ( SAH ) with total abdominal hysterectomy ( TAH ) at 5 years after surgery .
-METHODS	Randomised clinical trial with central , computer-generated randomisation .
-METHODS	Danish multi-centre trial performed in 11 departments of gynaecology .
-METHODS	Women referred with benign uterine diseases scheduled for abdominal hysterectomy .
-METHODS	Women were randomised to either SAH ( n = 161 ) or TAH ( n = 158 ) .
-METHODS	Follow-up data were collected from participants using postal questionnaires sent out 5 years after surgery .
-METHODS	Complications of hysterectomy were further examined by scrutinising registered discharge summaries following hospitalisation .
-METHODS	Intention-to-treat and per-protocol analyses were conducted .
-METHODS	Potential bias caused by missing data was handled using multiple imputation .
-METHODS	The primary outcome was UI .
-METHODS	Secondary outcomes included constipation , prolapse of the vaginal vault or cervical stump , satisfaction with sexual life , pelvic pain , postoperative complications and vaginal bleeding .
-RESULTS	The response rate was 234/319 ( 73.4 % ) .
-RESULTS	A significantly higher proportion of respondents had urinary incontinence 5 years after SAH 34/113 ( 30.1 % ) than TAH 21/119 ( 17.6 % ) ( RR 1.71 , 95 % confidence interval 1.06-2 .75 , P = 0.026 ) .
-RESULTS	This difference reduced after multiple imputation to account for missing data ( RR 1.37 , 95 % confidence interval 0.99-1 .89 , P = 0.052 ) .
-RESULTS	Eleven of the 101 women ( 11 % ) in the SAH group still experienced vaginal bleeding .
-RESULTS	No other differences were found between the two types of abdominal hysterectomy .
-CONCLUSIONS	A smaller proportion of women suffered from UI after TAH than after SAH 5 years postoperatively .
-CONCLUSIONS	Around one in ten women continued to experience vaginal bleeding 5 years after SAH .
-
-###24486352
-BACKGROUND	Two influenza B lineages have been co-circulating since the 1980s , and because inactivated trivalent influenza vaccine ( TIV ) contains only one B strain , it provides little/no protection against the alternate B-lineage .
-BACKGROUND	We assessed a candidate inactivated quadrivalent influenza vaccine ( QIV ) containing both B lineages versus TIV in healthy adults .
-METHODS	Subjects received one dose of QIV ( lot 1 , 2 , or 3 ) or one of two TIVs ( B strain from Victoria or Yamagata lineage ) ; randomization was 2:2:2:1:1 .
-METHODS	Hemagglutination-inhibition assays were performed 21-days post-vaccination ; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95 % confidence interval ( CI ) lower limit for the GMT ratio was 1.5 , and non-inferiority against the shared strains was demonstrated if the 95 % CI upper limit for the GMT ratio was 1.5 .
-METHODS	Reactogenicity and safety were assessed during the post-vaccination period .
-METHODS	NCT01196975 .
-RESULTS	Immunogenicity of QIV lots was consistent , QIV was superior to TIV for the alternate B-lineage strain , and QIV was non-inferior versus TIVs for shared strains ( A/H1N1 , A/H3N2 , B-strain ) .
-RESULTS	Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines .
-CONCLUSIONS	QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains , and without compromising safety .
-
-###24626435
-OBJECTIVE	The total enteroscopy rate of single-balloon enteroscopy ( SBE ) using air insufflation is not satisfactory , and whether carbon dioxide ( CO2 ) insufflation increases the total enteroscopy rate of SBE is unknown .
-OBJECTIVE	This randomised controlled trial aimed to determine whether CO2 insufflation facilitates the intubation depth and total enteroscopy rate of SBE .
-METHODS	A total of 214 eligible patients referred for SBE were randomised to receive either air or CO2 insufflation , and included in the intention-to-test ( ITT ) analysis .
-METHODS	In addition , 199 patients in whom enteroscopy was completed were included in the per-protocol ( PP ) analysis .
-METHODS	Both the patients and endoscopists were blinded , and the intubation depth and total enteroscopy rate were defined as the primary outcomes .
-RESULTS	The CO2 group showed a superiority of intubation in the ITT analysis ( oral route : 323.864.2 vs 238.368.6 cm ; anal route : 261.674.2 vs 174.762.1 cm , both p < 0.001 ) , and the total enteroscopy rate ( 34.9 % vs 17.6 % , p = 0.006 ) .
-RESULTS	Similar results were obtained in a PP analysis for both outcomes .
-RESULTS	In addition , in the PP analysis , the addition of circumference after the procedure was less in the CO2 group ( 0.80.6 vs 3.31.8 cm , p = 0.005 ) for the oral route .
-RESULTS	No serious complications were reported .
-RESULTS	The overall percentage of procedures with significant pathological findings was 52.8 % ; the rates were 58.5 % and 47.2 % ( p = 0.100 , ITT analysis ) in the CO2 and air groups , respectively .
-CONCLUSIONS	CO2 insufflation improves the intubation depth and total enteroscopy rate in SBE with a good safety profile and acceptability compared with that of air , and thus is recommended for clinical utilisation .
-BACKGROUND	ClinicalTrial.gov identifier : NCT01758900 .
-
-###24435025
-OBJECTIVE	The authors evaluated the effect of an electronic personal health record on the quality of medical care in a community mental health setting .
-METHODS	A total of 170 individuals with a serious mental disorder and a comorbid medical condition treated in a community mental health center were randomly assigned to either a personal health record or usual care .
-METHODS	One-year outcomes assessed quality of medical care , patient activation , service use , and health-related quality of life .
-RESULTS	Patients used the personal health record a mean of 42.1 times during the 1-year intervention period .
-RESULTS	In the personal health record group , the total proportion of eligible preventive services received increased from 24 % at baseline to 40 % at the 12-month follow-up , whereas it declined in the usual care group , from 25 % to 18 % .
-RESULTS	In the subset of patients with one or more cardiometabolic conditions ( N = 118 ) , the total proportion of eligible services received improved by 2 percentage points in the personal health record group and declined by 11 percentage points in the usual care group , resulting in a significant difference in change between the two groups .
-RESULTS	There was an increase in the number of outpatient medical visits , which appeared to explain many of the significant differences in the quality of medical care .
-CONCLUSIONS	Having a personal health record resulted in significantly improved quality of medical care and increased use of medical services among patients .
-CONCLUSIONS	Personal health records could provide a relatively low-cost scalable strategy for improving medical care for patients with comorbid medical and serious mental illnesses .
-
-###25158295
-BACKGROUND	Bioelectrical impedance analysis would be a more practical tool to measure body composition in clinical settings , dietetic practice and epidemiological studies if patients/subjects did not have to fast before measurements .
-BACKGROUND	The present study assessed whether the ingestion of food or drink had any biologically significant effect on bioimpedance measurements and body composition by the foot-to-foot method .
-METHODS	Fifty-five healthy adults [ 30 males and 25 females ; mean ( SD ) age 27.7 ( 7.1 ) years ; mean ( SD ) body mass index 24 ( 3.8 ) kg m ( -2 ) ] were randomly assigned to a 2-day food trial ( high-fat meal or high-carbohydrate meal ) or a 2-day drink trial ( water or high electrolyte drink ) .
-METHODS	Body composition measurements were carried out in the fasting state , immediately after meal consumption and every 30 min for 2 h by the foot-to-foot single frequency bioimpedance technique .
-RESULTS	Bioimpedance increased significantly after the ingestion of food and fluid , although the changes were small .
-RESULTS	The electrolyte drink , high-fat and high-carbohydrate meals significantly increased the percentage body fat and fat mass .
-RESULTS	In all cases , the median percentage changes from baseline were approximately 1 % in body fat percentage units .
-CONCLUSIONS	Although there were statistically significant changes in body composition estimates after food or drink consumption , these were small and within the imprecision of the impedance technique , and so are unlikely to be of clinical significance .
-CONCLUSIONS	The present study suggests that impedance measures of body fatness in clinical settings do not require strict adherence to fasting , and this should increase the opportunities for clinical application .
-
-###25586270
-OBJECTIVE	Hip fracture ( HF ) in frail elderly patients is associated with poor physical recovery and death .
-OBJECTIVE	There is often postoperative blood loss and the hemoglobin ( Hb ) threshold for red blood cell ( RBC ) transfusions in these patients is unknown .
-OBJECTIVE	We investigated whether RBC transfusion strategies were associated with the degree of physical recovery or with reduced mortality after HF surgery .
-METHODS	We enrolled 284 consecutive post-surgical HF patients ( aged 65 years ) with Hb levels < 11.3 g/dL ( 7 mmol/L ) who had been admitted from nursing homes or sheltered housing .
-METHODS	Allocation was stratified by residence .
-METHODS	The patients were randomly assigned to either restrictive ( Hb < 9.7 g/dL ; < 6 mmol/L ) or liberal ( Hb < 11.3 g/dL ; < 7 mmol/L ) RBC transfusions given within the first 30 days postoperatively .
-METHODS	Follow-up was at 90 days .
-RESULTS	No statistically significant differences were found in repeated measures of daily living activities or in 90-day mortality rate between the restrictive group ( where 27 % died ) and the liberal group ( where 21 % died ) .
-RESULTS	Per-protocol 30-day mortality was higher with the restrictive strategy ( hazard ratio ( HR ) = 2.4 , 95 % CI : 1.1-5 .2 ; p = 0.03 ) .
-RESULTS	The 90-day mortality rate was higher for nursing home residents in the restrictive transfusion group ( 36 % ) than for those in the liberal group ( 20 % ) ( HR = 2.0 , 95 % CI : 1.1-3 .6 ; p = 0.01 ) .
-CONCLUSIONS	According to our Hb thresholds , recovery from physical disabilities in frail elderly hip fracture patients was similar after a restrictive RBC transfusion strategy and after a liberal strategy .
-CONCLUSIONS	Implementation of a liberal RBC transfusion strategy in nursing home residents has the potential to increase survival .
-
-###25553506
-BACKGROUND	This prospective and randomized study was designed to compare safety , potential complications , and patient and examiner satisfaction of 2 anesthetic combinations - etomidate-remifentanil and propofol-remifentanil - in elderly patients undergoing diagnostic gastroscopy .
-METHODS	A group of 720 patients , aged 60-80 years , scheduled for diagnostic gastroscopy under sedation were prospectively randomized .
-METHODS	After 0.4-0 .6 g kg of remifentanil was infused , etomidate or propofol was administered .
-METHODS	Patients in the etomidate group received doses of etomidate at 0.1-0 .15 mg kg followed by 4-6 mg .
-METHODS	Patients in the propofol group received doses of propofol at 1-2 mg kg followed by 20-40 mg .
-METHODS	Physiological indexes were evaluated for the 715 of 720 patients that completed the treatment .
-METHODS	The onset time , duration time , and discharge time were recorded .
-METHODS	Physicians , anesthetists , and patients were surveyed to assess their satisfaction .
-RESULTS	Systolic pressure and diastolic pressure decreased significantly after the procedure in the propofol group ( P < 0.001 ) .
-RESULTS	The average heart rate was significantly lower in the propofol group ( P < 0.05 ) .
-RESULTS	No periods of desaturation ( SpO < 95 % ) were observed in either group .
-RESULTS	The onset time was earlier in the etomidate group ( P = 0.00 ) .
-RESULTS	All adverse events , with the exception of myoclonus , were greater in the propofol group , and physician and patient satisfaction in both groups was similar .
-CONCLUSIONS	Etomidate-remifentanil administration for sedation and analgesia during gastroscopy resulted in more stable hemodynamic responses and less adverse events in older patients .
-
-###25154469
-OBJECTIVE	Asynchronous e-learning allows for targeted teaching , particularly advantageous when bedside and didactic education is insufficient .
-OBJECTIVE	An asynchronous e-learning curriculum has not been studied across multiple centers in the context of a clinical rotation .
-OBJECTIVE	We hypothesize that an asynchronous e-learning curriculum during the pediatric emergency medicine ( EM ) rotation improves medical knowledge among residents and students across multiple participating centers .
-METHODS	Trainees on pediatric EM rotations at four large pediatric centers from 2012 to 2013 were randomized in a Solomon four-group design .
-METHODS	The experimental arms received an asynchronous e-learning curriculum consisting of nine Web-based , interactive , peer-reviewed Flash/HTML5 modules .
-METHODS	Postrotation testing and in-training examination ( ITE ) scores quantified improvements in knowledge .
-METHODS	A 2 2 analysis of covariance ( ANCOVA ) tested interaction and main effects , and Pearson 's correlation tested associations between module usage , scores , and ITE scores .
-RESULTS	A total of 256 of 458 participants completed all study elements ; 104 had access to asynchronous e-learning modules , and 152 were controls who used the current education standards .
-RESULTS	No pretest sensitization was found ( p = 0.75 ) .
-RESULTS	Use of asynchronous e-learning modules was associated with an improvement in posttest scores ( p < 0.001 ) , from a mean score of 18.45 ( 95 % confidence interval [ CI ] = 17.92 to 18.98 ) to 21.30 ( 95 % CI = 20.69 to 21.91 ) , a large effect ( partial ( 2 ) = 0.19 ) .
-RESULTS	Posttest scores correlated with ITE scores ( r ( 2 ) = 0.14 , p < 0.001 ) among pediatric residents .
-CONCLUSIONS	Asynchronous e-learning is an effective educational tool to improve knowledge in a clinical rotation .
-CONCLUSIONS	Web-based asynchronous e-learning is a promising modality to standardize education among multiple institutions with common curricula , particularly in clinical rotations where scheduling difficulties , seasonality , and variable experiences limit in-hospital learning .
-
-###25318667
-BACKGROUND	Apnoea , desaturations and bradycardias are common problems in preterm infants which can be treated with nasal continuous positive airway pressure ( NCPAP ) and nasal intermittent positive pressure ventilation ( NIPPV ) .
-BACKGROUND	It is unclear whether synchronised NIPPV ( SNIPPV ) would be even more effective .
-OBJECTIVE	To assess the effects of flow-SNIPPV , NIPPV and NCPAP on the rate of desaturations and bradycardias in preterm infants and , secondarily , to evaluate their influence on pattern of breathing and gas exchange .
-METHODS	Nineteen infants ( mean gestational age at study 30weeks , 9 boys ) with apnoeic spells were enrolled in a randomised controlled trial with a cross-over design .
-METHODS	They received flow-SNIPPV , NIPPV and NCPAP for 4h each .
-METHODS	All modes were provided by a nasal conventional ventilator able to provide synchronisation by a pneumotachograph .
-METHODS	The primary outcome was the event rate of desaturations ( 80 % arterial oxygen saturation ) and bradycardias ( 80bpm ) per hour , obtained from cardiorespiratory recordings .
-METHODS	The incidence of central apnoeas ( 10s ) as well as baseline heart rate , FiO2 , SpO2 , transcutaneous blood gases and respiratory rate were also evaluated .
-RESULTS	The median event rate per hour during flow-SNIPPV , NIPPV and NCPAP was 2.9 , 6.1 and 5.9 , respectively ( p < 0.001 and 0.009 , compared with flow-SNIPPV ) .
-RESULTS	Central apnoeas per hour were 2.4 , 6.3 and 5.4 , respectively ( p = 0.001 , for both compared with flow-SNIPPV ) , while no differences in any other parameter studied were recorded .
-CONCLUSIONS	Flow-SNIPPV seems more effective than NIPPV and NCPAP in reducing the incidence of desaturations , bradycardias and central apnoea episodes in preterm infants .
-
-###24909481
-OBJECTIVE	The aim of this study was to investigate the effect of different types of anesthesia on stress hormones .
-METHODS	The study was included 60 ASAI-II cases scheduled for major lower extremity surgery .
-METHODS	The cases were randomized into 2 groups : The EA group was administered epidural anesthesia and the GA group was administered standard general anesthesia .
-METHODS	In order to evaluate the surgical trauma - related stress response , CRP , TSH , cortisol , and fasting blood sugar ( FBS ) levels were measured preoperatively , 30 min after surgical incision , and 24 h post surgery .
-RESULTS	Between-group comparisons ; Preoperative values were not significantly different between the groups .
-RESULTS	( P > 0,05 ) Pulse rate and cortisol values significantly higher in general group at 30 min .
-RESULTS	( P < 0,05 ) , and the FBS values were significantly higher in the epidural group at 24 h. ( P < 0,05 ) There were not found differences for other parameters at evaluation times .
-CONCLUSIONS	No differences were observed between the two anesthesia methods , in terms of minimizing the stress response due to surgical trauma during major low extremity surgery .
-
-###25567841
-BACKGROUND	Inactivated polio vaccine ( IPV ) is necessary for global polio eradication because oral polio vaccine can rarely cause poliomyelitis as it mutates and may fail to provide adequate immunity in immunocompromised populations .
-BACKGROUND	However , IPV is unaffordable for many developing countries .
-BACKGROUND	Intradermal IPV shows promise as a means to decrease the effective dose and cost of IPV , but prior studies , all using 20 % of the standard dose used in intramuscular IPV , resulted in inferior antibody titers .
-METHODS	We randomly assigned 231 adults with well-controlled human immunodeficiency virus infection at a ratio of 2:2:2:1 to receive 40 % of the standard dose of IPV intradermally , 20 % of the standard dose intradermally , the full standard dose intramuscularly , or 40 % of the standard dose intramuscularly .
-METHODS	Intradermal vaccination was done using the NanoPass MicronJet600 microneedle device .
-RESULTS	Baseline immunity was 87 % , 90 % , and 66 % against poliovirus serotypes 1 , 2 , and 3 , respectively .
-RESULTS	After vaccination , antibody titers increased a median of 64-fold .
-RESULTS	Vaccine response to 40 % of the standard dose administered intradermally was comparable to that of the standard dose of IPV administered intramuscularly and resulted in higher ( although not significantly ) antibody titers .
-RESULTS	Intradermal administration had higher a incidence of local side effects ( redness and itching ) but a similar incidence of systemic side effects and was preferred by study participants over intramuscular administration .
-CONCLUSIONS	A 60 % reduction in the standard IPV dose without reduction in antibody titers is possible through intradermal administration .
-
-###25529384
-BACKGROUND	A current recommendation for locoregionally advanced nasopharyngeal carcinoma ( NPC ) is conventional fractionated radiotherapy with concurrent cisplatin plus adjuvant cisplatin and fluorouracil ( PF ) .
-BACKGROUND	In this randomized trial , the authors evaluated the potential therapeutic benefit from changing to an induction-concurrent chemotherapy sequence , replacing fluorouracil with oral capecitabine , and/or using accelerated rather than conventional radiotherapy fractionation .
-METHODS	Patients with stage III through IVB , nonkeratinizing NPC were randomly allocated to 1 of 6 treatment arms .
-METHODS	The protocol was amended in 2009 to permit confining randomization to the conventional fractionation arms .
-METHODS	The primary endpoint was progression-free survival .
-METHODS	Secondary endpoints included overall survival and safety .
-RESULTS	In total , 803 patients were accrued , and 706 patients were randomly allocated to all 6 treatment arms .
-RESULTS	Comparisons of induction PF versus adjuvant PF did not indicate a significant improvement .
-RESULTS	Unadjusted comparisons of induction cisplatin and capecitabine ( PX ) versus adjuvant PF indicated a favorable trend in progression-free survival for the conventional fractionation arm ( P = .045 ) ; analyses that were adjusted for other significant factors and fractionation reflected a significant reduction in the hazards of disease progression ( hazard ratio [ HR ] , 0.54 ; 95 % confidence interval [ CI ] , 0.36-0 .80 ) and death ( HR , 0.42 ; 95 % CI , 0.25-0 .70 ) .
-RESULTS	Unadjusted comparisons of induction sequences versus adjuvant sequences did not reach statistical significance , but adjusted comparisons indicated favorable improvements by induction sequence .
-RESULTS	Comparisons of induction PX versus induction PF revealed fewer toxicities ( neutropenia and electrolyte disturbance ) , unadjusted comparisons of efficacy were statistically insignificant , but adjusted analyses indicated that induction PX had a lower hazard of death ( HR , 0.57 ; 95 % CI , 0.34-0 .97 ) .
-RESULTS	Changing the fractionation from conventional to accelerated did not achieve any benefit but incurred higher toxicities ( acute mucositis and dehydration ) .
-CONCLUSIONS	Preliminary results indicate that the benefit of changing to an induction-concurrent sequence remains uncertain ; replacing fluorouracil with oral capecitabine warrants further validation in view of its convenience , favorable toxicity profile , and favorable trends in efficacy ; and accelerated fractionation is not recommended for patients with locoregionally advanced NPC who receive chemoradiotherapy .
-
-###24359507
-BACKGROUND	Cannabis is the most frequently used illegal substance in the United States and Europe .
-BACKGROUND	There is a dramatic increase in the demand for treatment for cannabis dependence .
-BACKGROUND	Cannabis users frequently have co-morbid mood symptoms , especially depression and anxiety , and regular cannabis users may self-medicate for such symptoms .
-OBJECTIVE	We report a double-blind , placebo-controlled treatment study , for the prevention of cannabis use in cannabis-dependent individuals .
-METHODS	Regular cannabis-dependent users ( n = 52 ) were treated for 9 weeks with weekly cognitive-behavior and motivation-enhancement therapy sessions together with escitalopram 10mg/day .
-METHODS	Urine samples were collected to monitor delta-9 tetrahydrocannabinol ( THC ) during treatment and questionnaires were administered to assess anxiety and depression .
-RESULTS	We observed a high rate of dropout ( 50 % ) during the 9-week treatment program .
-RESULTS	Fifty-two patients were included in the intention-to-treat analysis .
-RESULTS	Of these , ten ( 19 % ) remained abstinent after 9 weeks of treatment as indicated by negative urine samples for THC .
-RESULTS	Escitalopram provided no advantage over placebo in either abstinence rates from cannabis or anxiety and depression scores during the withdrawal and abstinent periods .
-CONCLUSIONS	Escitalopram treatment does not provide an additional benefit either for achieving abstinence , or for the treatment of the cannabis withdrawal syndrome .
-CONCLUSIONS	Due to limitations of our study , namely , a high dropout rate and effects of low abstinence rates on measures of anxiety , depression and withdrawal , it is premature to conclude that selective serotonin reuptake inhibitors are not effective for treatment of the cannabis withdrawal syndrome .
-
-###25464237
-BACKGROUND	Contrast medium-induced acute kidney injury ( CI-AKI ) is a cardiovascular complication after myocardial infarction treated with emergency percutaneous coronary intervention .
-BACKGROUND	The aim of this randomized , sham-controlled trial was to evaluate the impact of remote ischemic preconditioning ( RIPC ) on CI-AKI in patients with ST-elevation myocardial infarction who received emergency primary percutaneous coronary intervention .
-RESULTS	Patients with a suspected ST-elevation myocardial infarction were randomly assigned at a 1:1 ratio to receive percutaneous coronary intervention either with ( n = 63 ) or without ( n = 62 ) RIPC ( intermittent arm ischemia through three cycles of 5min of inflation and 5min of deflation of a blood pressure cuff ) .
-RESULTS	A total of 47 RIPC patients and 47 control patients met all study criteria .
-RESULTS	The primary endpoint was the incidence of CI-AKI , which was defined as an increase in serum creatinine > 0.5 mg/dL or > 25 % over the baseline value 48-72h after administration of contrast medium .
-RESULTS	The incidence of CI-AKI was 10 % ( n = 5 ) in the RIPC group and 36 % ( n = 17 ) in the control group ( p = 0.003 ) .
-RESULTS	The odds ratio of CI-AKI in patients who received RIPC was 0.18 ( 95 % confidence interval : 0.05-0 .64 ; p = 0.008 ) .
-CONCLUSIONS	In patients with ST-elevation myocardial infarction , RIPC before percutaneous coronary intervention reduced the incidence of CI-AKI .
-
-###24603102
-OBJECTIVE	We studied adjuvant daily sildenafil citrate during and after radiotherapy for prostate cancer for erectile function preservation .
-METHODS	We performed a randomized , prospective trial of 279patients with localized prostate cancer treated with radiotherapy who received sildenafil citrate ( 50 mg daily ) or placebo ( 2:1 randomization ) .
-METHODS	Medication/placebo was initiated 3 days before treatment and continued daily for 6months .
-METHODS	Before therapy and 3 , 6 , 9 , 12 , 18 and 24 months after radiotherapy patients completed the IIEF questionnaire , including the erectile function domain , the I-PSS questionnaire and the RAND SF-36 .
-METHODS	All IIEF domains werescored .
-RESULTS	At 12 months erectile function scores were better for sildenafil citrate than placebo ( p = 0.018 ) , 73 % of patients on sildenafil citrate vs 50 % on placebo had mild/no erectile dysfunction ( p = 0.024 ) and the sildenafil citrate arm had superior overall satisfaction ( p = 0.027 ) and IIEF total scores ( p = 0.043 ) .
-RESULTS	At 24months erectile function and IIEF scores were no longer significantly better for sildenafil citrate ( p = 0.172 and 0.09 , respectively ) and yet overall satisfaction scores were higher ( p = 0.033 ) .
-RESULTS	Sexual desire scores in patients who received sildenafil citrate were higher at 24 months although they had completed drug therapy 18 months previously ( p = 0.049 ) .
-RESULTS	At 24 months 81.6 % of patients on sildenafil citrate and 56.0 % of those on placebo achieved functional erection with or without erectile dysfunction medication ( p = 0.045 ) .
-CONCLUSIONS	Daily sildenafil citrate during and after radiotherapy for prostate cancer was associated with improved overall sexual function compared with placebo for various sexual function domains .
-CONCLUSIONS	To our knowledge this is the largestrandomized , prospective , controlled trial to show the usefulness of a phosphodiesterase-5 inhibitor as a rehabilitation strategy in patients with prostate cancer who received radiation therapy .
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-###24706498
-OBJECTIVE	EPHESUS was a multicentre , double-blind clinical trial in which 6632 patients with acute myocardial infarction ( AMI ) complicated by LV systolic dysfunction ( LVSD ) were randomized to receive eplerenone ( n = 3319 ) or placebo ( n = 3313 ) .
-OBJECTIVE	A total of 1580 EPHESUS patients were treated with PCI , which is now the standard treatment for AMI .
-OBJECTIVE	This EPHESUS substudy examined the effects of eplerenone upon cardiovascular outcomes in PCI-treated patients .
-RESULTS	EPHESUS patients were divided into PCI-treated and non-PCI-treated cohorts , and the effect of eplerenone upon mortality and other major adverse cardiovascular outcomes was assessed in each cohort .
-RESULTS	The PCI-treated patients ( n = 1580 ) were younger , and had better renal function and fewer co-morbidities than non-PCI-treated patients ( n = 5052 ) .
-RESULTS	Cardiovascular mortality was significantly lower in PCI-treated patients as compared with non-PCI-treated patients ( 7 % vs. 16 % , P < 0.0001 ) .
-RESULTS	However , the incidence of non-fatal events was similar in PCI-treated and non-PCI-treated cohorts .
-RESULTS	There was no statistical difference between the PCI-treated and non-PCI-treated cohorts in the primary or secondary outcomes of the trial .
-RESULTS	Eplerenone administration , compared with placebo , in the PCI-treated cohort did not affect PCI-related clinical outcomes , including recurrence of angina , the occurrence of acute coronary syndromes , or the need for further revascularization .
-CONCLUSIONS	The beneficial effects of eplerenone in the EPHESUS trial exist for both PCI - and non-PCI-treated AMI patients with LVSD .
-CONCLUSIONS	Eplerenone has minimal , if any , effect upon reducing PCI-related adverse events in the PCI-treated cohort .
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-###24936937
-OBJECTIVE	To test whether elevated umbilical cord serum inflammatory cytokine levels predicted subsequent cerebral palsy ( CP ) or neurodevelopmental delay ( NDD ) .
-METHODS	Nested case-control analysis within a clinical trial of antenatal magnesium sulfate ( MgSO4 ) before anticipated preterm birth ( PTB ) for prevention of CP , with evaluation of surviving children at the age of 2 .
-METHODS	NDD was defined as a Bayley psychomotor developmental index ( PDI ) and/or mental developmental index ( MDI ) < 70 .
-METHODS	Controls , defined as surviving children without CP and with Bayley PDI and MDI85 , were matched by race and gestational age .
-METHODS	Cord serum was analyzed for interleukin-8 ( IL-8 ) interleukin-1 beta ( IL-1 ) , and tumor necrosis factor - ( TNF - ) levels .
-METHODS	Elevated cytokine levels were defined as75th percentile in placebo-exposed controls .
-METHODS	Analyses compared case/control cytokine levels , adjusting for MgSO4 exposure , gestational age , race/ethnicity , and sociodemographic differences .
-RESULTS	Logistic regression analysis with 339 cases and 276 controls showed that elevated IL-8 and IL-1 were more common in cord blood serum from infants with subsequent low MDI as compared with controls .
-RESULTS	After adjusting for additional confounders , the significant differences were no longer evident .
-RESULTS	Cytokine levels ( IL-8 , IL-1 , and TNF - ) were not elevated with CP or low PDI .
-CONCLUSIONS	Cord serum IL-8 , IL-1 , and TNF - levels in preterm infants are not associated with subsequent CP or NDD .
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-###24674594
-BACKGROUND	Multiple tasking is an integral part of daily mobility .
-BACKGROUND	Patients with Parkinson 's disease have dual tasking difficulties due to their combined motor and cognitive deficits .
-BACKGROUND	Two contrasting physiotherapy interventions have been proposed to alleviate dual tasking difficulties : either to discourage simultaneous execution of dual tasks ( consecutive training ) ; or to practice their concurrent use ( integrated training ) .
-BACKGROUND	It is currently unclear which of these training methods should be adopted to achieve safe and consolidated dual task performance in daily life .
-BACKGROUND	Therefore , the proposed randomized controlled trial will compare the effects of integrated versus consecutive training of dual tasking ( tested by combining walking with cognitive exercises ) .
-METHODS	Hundred and twenty patients with Parkinson 's disease will be recruited to participate in this multi-centered , single blind , randomized controlled trial .
-METHODS	Patients in Hoehn & Yahr stage II-III , with or without freezing of gait , and who report dual task difficulties will be included .
-METHODS	All patients will undergo a six-week control period without intervention after which they will be randomized to integrated or consecutive task practice .
-METHODS	Training will consist of standardized walking and cognitive exercises delivered at home four times a week during six weeks .
-METHODS	Treatment is guided by a physiotherapist twice a week and consists of two sessions of self-practice using an MP3 player .
-METHODS	Blinded testers will assess patients before and after the control period , after the intervention period and after a 12-week follow-up period .
-METHODS	The primary outcome measure is dual task gait velocity , i.e. walking combined with a novel untrained cognitive task to evaluate the consolidation of learning .
-METHODS	Secondary outcomes include several single and dual task gait and cognitive measures , functional outcomes and a quality of life scale .
-METHODS	Falling will be recorded as a possible adverse event using a weekly phone call for the entire study period .
-CONCLUSIONS	This randomized study will evaluate the effectiveness and safety of integrated versus consecutive task training in patients with Parkinson 's disease .
-CONCLUSIONS	The study will also highlight whether dual task gait training leads to robust motor learning effects , and whether these can be retained and carried-over to untrained dual tasks and functional mobility .
-BACKGROUND	Clinicaltrials.gov NCT01375413 .
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-###25280603
-OBJECTIVE	To evaluate the efficacy of a novel , angular , continuous passive motion device for self-treatment at home in patients with mild-to-moderate , non-specific , chronic low back pain ( LBP ) .
-METHODS	Prospective , randomised , waiting-list-controlled ( WLC ) trial .
-METHODS	Recruitment and assessment were conducted at the Koren Centre for Physical Therapy .
-METHODS	Self-treatment was performed at home .
-METHODS	Thirty-six patients with a score 6 on the numeric rating scale ( NRS ) for pain were enrolled .
-METHODS	Twenty-eight patients completed treatment .
-METHODS	Participants were randomised to receive the Kyrobak ( Radiancy , Hod-hasharon , Israel ) at enrolment [ immediate treatment ( IT ) group ] or 3 weeks later ( WLC group ) .
-METHODS	Self-treatment was prescribed for 10minutes , one to three times per day , for 3 weeks .
-METHODS	The treatment period was followed by a 3-week follow-up period .
-METHODS	Primary outcome was self-reported pain level ( NRS ) .
-RESULTS	Three weeks of self-treatment with the Kyrobak reduced pain levels significantly in the IT group compared with the WLC group { mean [ standard deviation ( SD ) ] NRS score from baseline to post-treatment : IT group , 1.4 ( 1.5 ) , 95 % confidence interval ( CI ) 0.5 to 2.3 ; WLC group , -0.1 ( 2.2 ) , 95 % CI -1.1 to 1.2 ; effect mean difference 1.5 } .
-RESULTS	This benefit was maintained over the follow-up period [ from baseline to end of follow-up , mean ( SD ) NRS score 1.1 ( 1.8 ) , 95 % CI 0.4 to 1.8 ] .
-RESULTS	Multi-linear regression analysis found that higher baseline pain resulted in greater pain reduction ( P = 0.003 ) .
-RESULTS	Eighty-three percent of participants with a baseline NRS score > 4.35 ( threshold determined by logistic regression , P = 0.01 ) achieved the minimal important change criterion of NRS score 2 .
-RESULTS	Daily NRS score reduced gradually over the treatment period [ regression slope -0.052 ( 0.01 ) , 95 % CI -0.07 to -0.03 ] .
-CONCLUSIONS	Preliminary evidence suggests that the Kyrobak may be beneficial for short-term relief of non-specific , chronic LBP , particularly in participants with a moderate level of pain .
-CONCLUSIONS	A longer treatment period may lead to a further reduction in pain .
-
-###25041058
-OBJECTIVE	Our objective was to assess the safety , feasibility , and effects of the standardized 8-week mindfulness-based stress reduction ( MBSR ) course in adults with migraines .
-BACKGROUND	Stress is a well-known trigger for headaches .
-BACKGROUND	Research supports the general benefits of mind/body interventions for migraines , but there are few rigorous studies supporting the use of specific standardized interventions .
-BACKGROUND	MBSR is a standardized 8-week mind/body intervention that teaches mindfulness meditation/yoga .
-BACKGROUND	Preliminary research has shown MBSR to be effective for chronic pain syndromes , but it has not been evaluated for migraines .
-METHODS	We conducted a randomized controlled trial with 19 episodic migraineurs randomized to either MBSR ( n = 10 ) or usual care ( n = 9 ) .
-METHODS	Our primary outcome was change in migraine frequency from baseline to initial follow-up .
-METHODS	Secondary outcomes included change in headache severity , duration , self-efficacy , perceived stress , migraine-related disability/impact , anxiety , depression , mindfulness , and quality of life from baseline to initial follow-up .
-RESULTS	MBSR was safe ( no adverse events ) , with 0 % dropout and excellent adherence ( daily meditation average : 3411 minutes , range 16-50 minutes/day ) .
-RESULTS	Median class attendance from 9 classes ( including retreat day ) was 8 ( range [ 3 , 9 ] ) ; average class attendance was 6.7 2.5 .
-RESULTS	MBSR participants had 1.4 fewer migraines/month ( MBSR : 3.5 to 1.0 vs control : 1.2 to 0 migraines/month , 95 % confidence interval CI [ -4.6 , 1.8 ] , P = .38 ) , an effect that did not reach statistical significance in this pilot sample .
-RESULTS	Headaches were less severe , although not significantly so ( -1.3 points/headache on 0-10 scale , [ -2.3 , 0.09 ] , P = .053 ) and shorter ( -2.9 hours/headache , [ -4.6 , -0.02 ] , P = .043 ) vs control .
-RESULTS	Migraine Disability Assessment and Headache Impact Test-6 dropped in MBSR vs control ( -12.6 , [ -22.0 , -1.0 ] , P = .017 and -4.8 , [ -11.0 , -1.0 ] , P = .043 , respectively ) .
-RESULTS	Self-efficacy and mindfulness improved in MBSR vs control ( 13.2 [ 1.0 , 30.0 ] , P = .035 and 13.1 [ 3.0 , 26.0 ] , P = .035 respectively ) .
-CONCLUSIONS	MBSR is safe and feasible for adults with migraines .
-CONCLUSIONS	Although the small sample size of this pilot trial did not provide power to detect statistically significant changes in migraine frequency or severity , secondary outcomes demonstrated this intervention had a beneficial effect on headache duration , disability , self-efficacy , and mindfulness .
-CONCLUSIONS	Future studies with larger sample sizes are warranted to further evaluate this intervention for adults with migraines .
-CONCLUSIONS	This study was prospectively registered ( ClinicalTrials.gov identifier NCT01545466 ) .
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-###24528935
-OBJECTIVE	To evaluate the possible advantages of combination therapy with diquafosol tetrasodium and sodium hyaluronate for dry eye after laser in situ keratomileusis ( LASIK ) .
-METHODS	Prospective randomized comparative trial .
-METHODS	A total of 206 eyes of 105 patients who underwent LASIK were enrolled in this study .
-METHODS	Patients were randomly assigned to 1 of 4 treatment groups according to the postoperative treatment : artificial tears , sodium hyaluronate , diquafosol tetrasodium , and a combination of hyaluronate and diquafosol .
-METHODS	Questionnaire responses reflecting subjective dry eye symptoms , uncorrected and corrected visual acuity , functional visual acuity , manifest refraction , tear break-up time , fluorescein corneal staining , Schirmer test , and corneal sensitivity were examined before and 1 week and 1 month after LASIK .
-RESULTS	Distance uncorrected visual acuity was significantly better in the combination group than in the hyaluronate group 1 week and 1 month after LASIK .
-RESULTS	Near uncorrected visual acuity was significantly better in the combination group than in the artificial tear and diquafosol groups 1 week and 1 month after LASIK .
-RESULTS	Distance functional visual acuity improved significantly only in the combination group 1 month after LASIK .
-RESULTS	The Schirmer value in the combination group was significantly higher than that in the hyaluronate group at 1 month after LASIK .
-RESULTS	Subjective dry eye symptoms in the combination group improved significantly compared with those in the other groups 1 week after surgery .
-CONCLUSIONS	Our results suggest that hyaluronate and diquafosol combination therapy is beneficial for early stabilization of visual performance and improvement of subjective dry eye symptoms in patients after LASIK .
-
-###24341465
-BACKGROUND	Management of Type 1 diabetes comes with substantial personal and psychological demands particularly during adolescence , placing young people at significant risk for mental health problems .
-BACKGROUND	Supportive parenting can mitigate these risks , however the challenges associated with parenting a child with a chronic illness can interfere with a parent 's capacity to parent effectively .
-BACKGROUND	Interventions that provide support for both the adolescent and their parents are needed to prevent mental health problems in adolescents ; to support positive parent-adolescent relationships ; and to empower young people to better self-manage their illness .
-BACKGROUND	This paper presents the research protocol for a study evaluating the efficacy of the Nothing Ventured Nothing Gained online adolescent and parenting intervention which aims to improve the mental health outcomes of adolescents with Type 1 diabetes .
-METHODS	A randomized controlled trial using repeated measures with two arms ( intervention and wait-list control ) will be used to evaluate the efficacy and acceptability of the online intervention .
-METHODS	Approximately 120 adolescents with Type 1 diabetes , aged 13-18 years and one of their parents/guardians will be recruited from pediatric diabetes clinics across Victoria , Australia .
-METHODS	Participants will be randomized to receive the intervention immediately or to wait 6 months before accessing the intervention .
-METHODS	Adolescent , parent and family outcomes will be assessed via self-report questionnaires at three time points ( baseline , 6 weeks and 6 months ) .
-METHODS	The primary outcome is improved adolescent mental health ( depression and anxiety ) .
-METHODS	Secondary outcomes include adolescent behavioral ( diabetes self-management and risk taking behavior ) , psychosocial ( diabetes relevant quality of life , parent reported child well-being , self-efficacy , resilience , and perceived illness benefits and burdens ) ; metabolic ( HbA1c ) outcomes ; parent psychosocial outcomes ( negative affect and fatigue , self-efficacy , and parent experience of child illness ) ; and family outcomes ( parent and adolescent reported parent-adolescent communication , responsibility for diabetes care , diabetes related conflict ) .
-METHODS	Process variables including recruitment , retention , intervention completion and intervention satisfaction will also be assessed .
-CONCLUSIONS	The results of this study will provide valuable information about the efficacy , acceptability and therefore the viability of delivering online interventions to families affected by chronic illnesses such as Type 1 diabetes .
-BACKGROUND	Australian New Zealand clinical trials registry ( ANZCTR ) ; ACTRN12610000170022 .
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-###24992083
-OBJECTIVE	The aim of this study was to investigate the effects of piribedil on vigilance and cognitive performance in patients with Parkinson disease experiencing excessive daytime sleepiness on pramipexole or ropinirole .
-METHODS	In this 11-week randomized , active-controlled , rater-blinded phase III study , eligible patients were randomly assigned to either receive piribedil or to continue on pramipexole or ropinirole .
-METHODS	The primary outcome was the median reaction times during the second 15 minutes of the subtest `` vigilance '' of the Test battery for Attention Performances ( TAP ) .
-METHODS	Secondary outcomes included the Epworth Sleepiness Scale , Unified Parkinson 's Disease Rating Scale , neuropsychological testing , and items of the Clinical Global Impression .
-RESULTS	Forty-four patients received piribedil ; 36 continued on either pramipexole or ropinirole .
-RESULTS	There was no difference in the primary end point reaction time of the TAP subtest vigilance between piribedil and the comparator ( 996 vs 954 milliseconds , P = 0.68 ) .
-RESULTS	Piribedil reduced daytime sleepiness with lower Epworth Sleepiness Scale scores at the end of treatment compared with the comparator ( -4 vs -2 points ; P = 0.01 ) .
-RESULTS	The median Unified Parkinson 's Disease Rating Scale III score at the end of treatment was comparable between the 2 groups .
-RESULTS	Neuropsychological tests revealed no significant between-treatment differences .
-RESULTS	A higher therapeutic effect and global improvement were shown by the Clinical Global Impression of piribedil-treated patients .
-CONCLUSIONS	This study shows that switching from pramipexole or ropinirole to piribedil has no effect on the reaction time of the TAP subtest vigilance but upholds the same therapeutic motor effect and reduces daytime sleepiness to a clinically relevant degree in patients with excessive daytime sleepiness .
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-###24267397
-BACKGROUND	A fractional erbium-doped glass 1,550-nm and a fractional bipolar radiofrequency ( RF ) device are effective in the treatment of atrophic acne scars .
-OBJECTIVE	To compare the clinical effectiveness and side effects of fractional bipolar RF with those of fractional erbium-doped glass in atrophic acne scars treatment .
-METHODS	Twenty Thai subjects with atrophic acne scars received three split-face monthly treatments , one side with fractional bipolar RF and the other with fractional erbium-doped glass .
-METHODS	Three independent physicians and patients evaluated improvement in acne scars 4weeks after the last treatment .
-METHODS	Side effects were also recorded after each treatment .
-RESULTS	The study found significant improvement in acne scars after treatment with fractional bipolar RF and with a fractional erbium-doped glass device without a statistically significant difference between the two devices .
-RESULTS	The side effects of both devices were pain , transient facial erythema , and scab formation .
-RESULTS	The pain score with fractional erbium-doped glass was higher than that with fractional bipolar RF , but duration of scab shedding was shorter .
-RESULTS	One case had postinflammatory hyperpigmentation on only the side treated with fractional erbium-doped glass .
-CONCLUSIONS	Fractional bipolar RF and fractional erbium-doped glass have similar effectiveness for the treatment of atrophic acne scars .
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-###25588353
-BACKGROUND	Levodopa-carbidopa intestinal gel ( LCIG ) is delivered continuously via intrajejunal percutaneous gastrostomy tube .
-OBJECTIVE	To examine long-term safety , efficacy and quality of life of LCIG in an open-label extension study .
-METHODS	Patients received 52 weeks of open-label LCIG treatment following a 12-week double-blind , double-dummy trial in which they were randomized to either LCIG or immediate-release oral levodopa-carbidopa .
-METHODS	Patient cohort designation was by receipt of LCIG in the preceding trial randomization ( continuing-LCIG vs. LCIG-nave patients ) .
-RESULTS	Sixty-two of 66 subjects in the double-blind proceeded to the open-label extension .
-RESULTS	Most subjects ( 95 % ) reported 1 adverse event ( AE ) ; only 3 subjects ( 4.8 % ) discontinued due to AEs .
-RESULTS	AE incidence declined gradually over 52 weeks .
-RESULTS	Serious AEs were reported by 23 % .
-RESULTS	LCIG-nave patients ( N = 29 ) showed a decrease in `` Off '' time and an increase in `` On '' time without troublesome dyskinesia ( change from baseline to final visit in mean [ SD ] hours = -2.34 [ 2.78 ] P < 0.001 and 2.19 [ 3.70 ] P = 0.005 , respectively ) , while continuing-LCIG patients ( N = 33 ) showed sustained `` Off '' time duration and further improvement in `` On '' time without troublesome dyskinesia ( -0.42 [ 2.67 ] P = 0.377 and 1.00 [ 2.58 ] P = 0.036 , respectively ) .
-RESULTS	The majority of patients in both groups ( LCIG-nave , continuing-LCIG , respectively ) were rated ` Much Improved ' or ` Very Much Improved ' at final visit on the Clinical Global Impression-Improvement scale ( 69.0 % , 69.7 % ) .
-CONCLUSIONS	Continuing-LCIG patients continued to derive benefit from LCIG while the magnitude of improvement among LCIG-nave patients was similar to that observed for patients on LCIG in the preceding double-blind study .
-CONCLUSIONS	The overall AE profile was consistent with previous phase 3 clinical trials involving the LCIG system .
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-###25314648
-BACKGROUND	The clinical epidemiology of acanthosis nigricans ( AN ) has not been entirely studied .
-BACKGROUND	Most studies mention only its prevalence taking any `` typical site '' as a whole .
-BACKGROUND	These studies were carried out at different ages , races , anthropometries , and skin phototypes without analyzing the comparative clinical connotation of different sites .
-BACKGROUND	Furthermore , it has never been explored as a potential early expression of insulin resistance before it becomes clinically evident .
-BACKGROUND	The objective was to determine the prevalence and body distribution of AN in easy-access sites to physical examination in a Latin American youth population and its clinical implications as an early marker for obesity .
-METHODS	We conducted a prospective , cross-sectional , observational study in 703 randomly selected students .
-METHODS	Participants ' mean age was 19.11.68 years .
-METHODS	Overweight and obesity occurred in 23.6 % and 6.8 % , respectively .
-METHODS	3 observers blindly assessed neck , axillae , elbow and knuckles .
-RESULTS	AN was identified in any of the examined sites in 47.8 % of the participants .
-RESULTS	Its prevalence increased from 41 % to 86 % from normal to obese anthropometric categories .
-RESULTS	AN occurred in 1-4 sites in 23.1 % , 10.8 % , 6.9 % and 7.1 % of cases , respectively .
-RESULTS	The knuckles was the site with the highest prevalence of AN as an overall group ( 31.3 % ) and in the normal ( 24.9 % ) and overweight body mass index ( 46.4 % ) categories and there was a higher prevalence in the cases above the median in the normal body mass index category .
-RESULTS	In the obese group , AN was slightly more common in the neck but all sites had a very similar high prevalence .
-CONCLUSIONS	AN occurs with a high prevalence in Latin American youths , and its prevalence is much higher in a `` non-classical '' and ignored location where it is very easy to detect during physical examination : the knuckles .
-CONCLUSIONS	It may also occur earlier in this location in the evolution to obesity .
-CONCLUSIONS	The presence of AN in the knuckles in any patient , even if they have a normal body mass index , might indicate the likelihood of an early clinical manifestation of insulin resistance and metabolic consequences .
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-###25387260
-BACKGROUND	In older adults , loss of mobility due to sarcopenia is exacerbated in men with low serum T. T replacement therapy is known to increase muscle mass and strength , but the effect of weekly ( WK ) vs monthly ( MO ) administration on specific fiber types is unknown .
-OBJECTIVE	To determine the efficacy of WK vs MO T replacement on the size and functional capacity of individual fast and slow skeletal muscle fiber types .
-METHODS	Subjects were randomized into a 5-month , double-blind , placebo-controlled trial .
-METHODS	All subjects ( ages , 61-71 y ) were community-dwelling men who had T levels < 500 ng/dL .
-METHODS	Subjects were dosed weekly for 5 months , receiving continuous T ( WK , n = 5 ; 100 mg T enanthate , im injection ) , monthly cycled T ( MO , n = 7 ; alternating months of T and placebo ) , or placebo ( n = 7 ) .
-METHODS	Muscle biopsies of the vastus lateralis were obtained before and after treatment .
-METHODS	Main outcomes for individual slow and fast fibers included fiber diameter , peak force ( P0 ) , rate of tension development , maximal shortening velocity , peak power , and Ca ( 2 + ) sensitivity .
-RESULTS	Both treatments increased fiber diameter and peak power , with WK treatment 5-fold more effective than MO in increasing type I fiber P0 .
-RESULTS	WK effects on fiber diameter and force were 1.5-fold higher in slow fibers compared to fast fibers .
-RESULTS	In fast type II fibers , diameter and P0 increased similarly between treatments .
-RESULTS	The increased power was entirely due to increased fiber size and force .
-CONCLUSIONS	In conclusion , T replacement effects were fiber-type dependent , restricted to increases in cell size , P0 , and peak power , and dependent on the paradigm selected ( WK vs MO ) .
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-###25510286
-BACKGROUND	Postoperative atrial fibrillation ( POAF ) is a common complication after cardiac surgery and predicts increased morbidity and mortality .
-BACKGROUND	Identification of patients at high risk of POAF with the help of circulating biomarkers may enable early preventive treatment but data are limited , especially in contemporary surgical patients .
-METHODS	Plasma concentrations of N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) and high-sensitivity cardiac troponin T ( hs-cTnT ) were measured at enrollment , on the morning of cardiac surgery , at end surgery , and 2 days postsurgery in 562 patients undergoing cardiac surgery , randomized to perioperative supplementation with oral fish oil or placebo in the Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation trial ( OPERA ) .
-METHODS	The primary endpoint was incident POAF lasting 30 s , centrally adjudicated and confirmed electrocardiographically .
-RESULTS	Higher levels of NT-proBNP and hs-cTnT before surgery were associated with older age , renal or cardiac dysfunction and EuroSCORE .
-RESULTS	NT-proBNP peaked on postoperative day 2 ( 2172 [ 1238-3758 ] ng/L , median [ Q1-Q3 ] ) , while hs-cTnT peaked at the end of surgery ( 373 [ 188-660 ] ng/L ) .
-RESULTS	Fish oil supplementation did not alter the time course of the cardiac biomarkers ( P > 0.05 ) .
-RESULTS	Concentrations of NT-proBNP or hs-cTnT , on the morning of surgery , or changes in their level between morning of surgery and postsurgery , were not significantly associated with POAF after adjustment for clinical and surgical characteristics .
-CONCLUSIONS	Among patients undergoing cardiac surgery , NT-proBNP and hs-cTnT are related to clinical and surgical characteristics , have different perioperative time courses but are not independently associated with risk of POAF .
-
-###26241420
-OBJECTIVE	To evaluate whether myo-inositol supplementation , an insulin sensitizer , reduces the rate of gestational diabetes mellitus ( GDM ) and lowers insulin resistance in obese pregnant women .
-METHODS	In an open-label , randomized trial , myo-inositol ( 2 g plus 200 micrograms folic acid twice a day ) or placebo ( 200 micrograms folic acid twice a day ) was administered from the first trimester to delivery in pregnant obese women ( prepregnancy body mass index 30 or greater .
-METHODS	We calculated that 101 women in each arm would be required to demonstrate a 65 % GDM reduction in the myo-inositol group with a statistical power of 80 % ( = 0.05 ) .
-METHODS	The primary outcomes were the incidence of GDM and the change in insulin resistance from enrollment until the diagnostic oral glucose tolerance test .
-RESULTS	From January 2011 to April 2014 , 220 pregnant women at 12-13 weeks of gestation were randomized at two Italian university hospitals , 110 to myo-inositol and 110 to placebo .
-RESULTS	Most characteristics were similar between groups .
-RESULTS	The GDM rate was significantly reduced in the myo-inositol group compared with the control group , 14.0 % compared with 33.6 % , respectively ( P = .001 ; odds ratio 0.34 , 95 % confidence interval 0.17-0 .68 ) .
-RESULTS	Furthermore , women treated with myo-inositol showed a significantly greater reduction in the homeostasis model assessment of insulin resistance compared with the control group , -1.03.1 compared with 0.11.8 ( P = .048 ) .
-CONCLUSIONS	Myo-inositol supplementation , started in the first trimester , in obese pregnant women seems to reduce the incidence in GDM through a reduction of insulin resistance .
-BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01047982 .
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-###24245491
-BACKGROUND	A major barrier to successful treatment in alcohol dependence is psychiatric comorbidity .
-BACKGROUND	During treatment , the time to relapse is shorter , the drop-out rate is increased , and long-term alcohol consumption is greater for those with comorbid major depression or anxiety disorder than those with an alcohol use disorder with no comorbid mental disorder .
-BACKGROUND	The treatment of alcohol dependence and psychological disorders is often the responsibility of different services , and this can hinder the treatment process .
-BACKGROUND	Accordingly , there is a need for an effective integrated treatment for alcohol dependence and comorbid anxiety and/or depression .
-METHODS	We aim to assess the effectiveness of a specialized , integrated intervention for alcohol dependence with comorbid anxiety and/or mood disorder using a randomized design in an outpatient hospital setting .
-METHODS	Following a three-week stabilization period ( abstinence or significantly reduced consumption ) , participants will undergo complete formal assessment for anxiety and depression .
-METHODS	Those patients with a diagnosis of an anxiety and/or depressive disorder will be randomized to either 1 ) integrated intervention ( cognitive behavioral therapy ) for alcohol , anxiety , and/or depression ; or 2 ) usual counseling care for alcohol problems .
-METHODS	Patients will then be followed up at weeks 12 , 16 , and 24 .
-METHODS	The primary outcome measure is alcohol consumption ( total abstinence , time to lapse , and time to relapse ) .
-METHODS	Secondary outcome measures include changes in alcohol dependence severity , depression , or anxiety symptoms and changes in clinician-rated severity of anxiety and depression .
-CONCLUSIONS	The study findings will have potential implications for clinical practice by evaluating the implementation of specialized integrated treatment for comorbid anxiety and/or depression in an alcohol outpatient service .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT01941693 .
-
-###24627552
-OBJECTIVE	To determine the efficacy of 16 hour nicotine patches among pregnant smokers , with the dose individually adjusted according to saliva cotinine levels ( potential range 10-30 mg/day ) .
-METHODS	Randomised , double blind , placebo controlled , parallel group , multicentre trial ( Study of Nicotine Patch in Pregnancy , SNIPP ) between October 2007 and January 2013 .
-METHODS	23 maternity wards in France .
-METHODS	476 pregnant smokers aged more than 18 years and between 12 and 20 weeks ' gestation , who smoked at least five cigarettes a day .
-METHODS	After exclusions , 402 women were randomised : 203 to nicotine patches and 199 to placebo patches .
-METHODS	Data were available on 192 live births in each group .
-METHODS	Nicotine and identical placebo patches were administered from quit day up to the time of delivery .
-METHODS	Doses were adjusted to saliva cotinine levels when smoking to yield a substitution rate of 100 % .
-METHODS	Participants were assessed monthly and received behavioural smoking cessation support .
-METHODS	The primary outcomes were complete abstinence ( self report confirmed by carbon monoxide level in expired air 8 ppm ) from quit date to delivery , and birth weight .
-METHODS	The secondary outcomes were point prevalence of abstinence , time to lapse ( a few puffs ) or relapse , and delivery and birth characteristics .
-METHODS	All data were analysed on an intention to treat basis .
-RESULTS	Complete abstinence was achieved by 5.5 % ( n = 11 ) of women in the nicotine patch group and 5.1 % ( n = 10 ) in the placebo patch group ( odds ratio 1.08 , 95 % confidence interval 0.45 to 2.60 ) .
-RESULTS	The median time to the first cigarette smoked after target quit day was 15 days in both groups ( interquartile range 13-18 in the nicotine patch group , 13-20 in the placebo patch group ) .
-RESULTS	The point prevalence abstinence ranged from 8 % to 12.5 % in the nicotine patch group and 8 % to 9.5 % in the placebo patch group without statistically significant differences .
-RESULTS	The nicotine substitution rate did not differ from 100 % , and the self reported median compliance rate was 85 % ( interquartile range 56-99 % ) in the nicotine patch group and 83 % ( 56-95 % ) in the placebo patch group , assessed at 1016 visits .
-RESULTS	The mean birth weight was 3065 g ( SE 44 g ) in the nicotine patch group and 3015 g ( SE 44 g ) in the placebo patch group ( P = 0.41 ) .
-RESULTS	Diastolic blood pressure was significantly higher in the nicotine patch group than in the placebo patch group .
-RESULTS	The frequency of serious adverse events was similar between the groups , although more non-serious adverse reactions , mainly of skin , occurred in the nicotine patch group .
-CONCLUSIONS	The nicotine patch did not increase either smoking cessation rates or birth weights despite adjustment of nicotine dose to match levels attained when smoking , and higher than usual doses .
-BACKGROUND	ClinicalTrials.gov NCT00507975 .
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-###24875194
-OBJECTIVE	Once-daily losartan reduces BP in a dose-dependent manner and is well tolerated in hypertensive children aged 6-16 years .
-OBJECTIVE	This study assessed the dose-response relationship , safety , and tolerability of losartan in hypertensive children aged 6 months to 6 years .
-METHODS	This was a 12-week , randomized , open-label , dose-ranging study , with a 2-year extension .
-METHODS	Patients were randomized to losartan at the following dosages : 0.1 mg/kg per day ( low ) , 0.3 mg/kg per day ( medium ) , or 0.7 mg/kg per day ( high ) .
-METHODS	Losartan was titrated to the next dose level ( to a 1.4 mg/kg per day maximum dosage , not exceeding 100 mg/d , which was not one of the three original doses offered at randomization ) at weeks 3 , 6 , and 9 for patients who did not attain their goal BP and were not taking the highest dose .
-METHODS	Dose response was evaluated by analyzing the slope of change in sitting systolic BP ( SBP ; primary end point ) and diastolic BP ( DBP ; secondary end point ) after 3 weeks compared with baseline .
-METHODS	Adverse events ( AEs ) were recorded throughout .
-RESULTS	Of the 101 patients randomized , 99 were included in the analysis ( low dose , n = 32 ; medium dose , n = 34 ; and high dose , n = 33 ) .
-RESULTS	Mean sitting BP decreased from baseline in the low - , medium - , and high-dose groups by 7.3 , 7.6 , and 6.7 mmHg , respectively , for SBP and 8.2 , 5.1 , and 6.7 mmHg , respectively , for DBP after 3 weeks .
-RESULTS	No dose-response relationship was established by the slope analysis on SBP ( P = 0.75 ) or DBP ( P = 0.64 ) .
-RESULTS	The BP-lowering effect was observed throughout the 2-year extension .
-RESULTS	The incidence of AEs was low and comparable between groups .
-CONCLUSIONS	Hypertensive children aged 6 months to 6 years treated with losartan 0.1-0 .7 mg/kg per day had clinically significant decreases from baseline in SBP and DBP , yet no dose-response relationship was evident .
-CONCLUSIONS	Losartan , at a dosage up to 1.4 mg/kg per day , was well tolerated .
-
-###25537234
-BACKGROUND	The yellow-card scheme continues to be one of the principal methods for signal generation in pharmacovigilance .
-BACKGROUND	Nevertheless , under-reporting , one of its disadvantages , delays alert signals and has a negative influence on public health .
-BACKGROUND	Educational interventions in pharmacovigilance may have a positive impact on the spontaneous reporting of adverse drug reactions ( ADRs ) .
-OBJECTIVE	To assess the duration of the effect and effectiveness of an educational intervention in pharmacovigilance designed to improve ADR reporting in a robust pharmacovigilance system .
-METHODS	A spatial , cluster randomized controlled trial was conducted covering all National Health System physicians in the northwest of Spain and targeting those who were actively engaged in clinical practice ( n = 7,498 ) .
-METHODS	Of these , 2,120 were assigned in three spatial clusters to the intervention group ( six hospitals and 138 primary care centers ) and 3,614 in four clusters to the control group ( seven hospitals and 267 primary care centers ) .
-METHODS	The educational intervention consisted of two complementary approaches -- one active ( group sessions ) , the other passive ( educational material , reporting form ) - implemented from November 2007 to December 2008 , with a follow-up period of 8 months .
-RESULTS	Intervention participation was 53.7 % in a hospital setting and 60.5 % in primary care settings .
-RESULTS	ADR reporting in the intervention group increased by 65.4 % ( 95 % confidence interval [ CI ] : 8.2-153 .4 ) across the follow-up .
-RESULTS	The ADR reporting rate per 1,000 physicians/year in the intervention group rose from 28.1 to 39.6 following the intervention ( 51.7 and 27.4 in the first and second 4-month period , respectively ) .
-RESULTS	For the intervention group , relative risk ( RR ) was 2.31 ( 95 % CI : 1.46-3 .68 ) and 1.04 ( 95 % CI : 0.61-1 .77 ) in the first and second 4-month period , respectively adjusted to baseline values .
-RESULTS	There was an increase in unexpected ADR reporting ( RR 2.06 , 95 % CI 1.19-3 .55 ) .
-CONCLUSIONS	Pharmacovigilance educational interventions that have proved effective can be successfully applied in different geographical areas .
-CONCLUSIONS	A high baseline notification rate could account for the educational program having a moderate effect .
-
-###24683571
-OBJECTIVE	This 1-year randomized controlled prospective study evaluated the implant success rate and peri-implant tissue response following single immediate implant placement and provisionalization ( IIPP ) with and without subepithelial connective tissue graft ( SCTG ) in the esthetic zone .
-METHODS	Implants were placed either IIPP with SCTG ( test group ) or IIPP without SCTG ( control group ) .
-METHODS	The implants were evaluated both clinically and radiographically before surgery , immediately after implant placement , and 3 , 6 , and 12 months after implant placement .
-METHODS	Data were analyzed using Friedman , Wilcoxon signed-rank , and Mann-Whitney U tests at the significance level of = .05 .
-RESULTS	Twenty implants ( 10 test , 10 control ) were placed in 20 patients ( 7 men , 13 women ) between the ages of 27 and 87 ( mean age , 52.6 years ) .
-RESULTS	At 1 year , all implants remained osseointegrated , with overall mean marginal bone changes of -0.01 mm and -0.14 mm for the test and control groups , respectively .
-RESULTS	Mean facial gingival level change was significantly more pronounced in the control group ( -0.70 mm ) than in the test group ( -0.25 mm ) .
-RESULTS	The modified Plaque Index scores showed that patients were able to maintain a good level of hygiene throughout the study .
-RESULTS	At 1 year , the Papilla Index indicated that more than 50 % papilla fill was observed in 75 % of the test sites and 80 % of the control sites .
-CONCLUSIONS	Within the limitations of this study , SCTG was shown to be beneficial in maintaining facial gingival level when performed in conjunction with IIPP procedures .
-
-###25742208
-OBJECTIVE	Naltrexone , an opioid antagonist , may facilitate reduction in drinking among young adults .
-OBJECTIVE	We compared the efficacy and safety of naltrexone administered daily plus targeted dosing with placebo to reduce drinking in young adults who engage in heavy drinking .
-METHODS	A randomized , double-blind , placebo-controlled study was conducted in an outpatient research center in March 2008-January 2012 .
-METHODS	Participants were aged 18-25 years and reported 4 heavy drinking days in the prior 4 weeks .
-METHODS	Interventions included naltrexone 25 mg daily plus 25 mg targeted ( at most daily ) in anticipation of drinking ( n = 61 ) or daily/targeted placebo ( n = 67 ) .
-METHODS	All participants received a personalized feedback session and brief counseling every other week .
-METHODS	Primary outcomes were percent heavy drinking days and percent days abstinent over the 8-week treatment period .
-METHODS	Secondary outcomes included number of drinks per drinking day and percentage of days with estimated blood alcohol concentration ( BAC ) levels 0.08 g/dL .
-RESULTS	Of 140 randomized patients , 128 began treatment , comprising the evaluable sample .
-RESULTS	During treatment , percent heavy drinking days ( naltrexone : mean = 21.60 , SD = 16.05 ; placebo : mean = 22.90 , SD = 13.20 ) ( P = .58 ) and percent days abstinent ( naltrexone : mean = 56.60 , SD = 22.52 ; placebo : mean = 62.50 , SD = 15.75 ) ( P = .39 ) did not differ by group .
-RESULTS	Naltrexone significantly reduced the number of drinks per drinking day ( naltrexone : mean = 4.90 , SD = 2.28 ; placebo : mean = 5.90 , SD = 2.51 ) ( P = .009 ) and percentage of drinking days with estimated BAC 0.08 g/dL ( naltrexone : mean = 35.4 , SD = 28.40 ; placebo : mean = 45.7 , SD = 26.80 ) ( P = .042 ) .
-RESULTS	There were no serious adverse events .
-RESULTS	Sleepiness was more common with naltrexone .
-CONCLUSIONS	Naltrexone did not reduce frequency of drinking or heavy drinking days , but reduced secondary measures of drinking intensity .
-CONCLUSIONS	While effects were modest , the risk-benefit ratio favors offering naltrexone to help young adult heavy drinkers reduce the amount of alcohol they drink .
-BACKGROUND	ClinicalTrials.gov identifier : NCT00568958 .
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-###24327455
-OBJECTIVE	Neointimal hyperplasia secondary to vascular smooth muscle cell ( VSMC ) activation limits the long-term patency of saphenous vein grafts ( SVGs ) .
-OBJECTIVE	We compared markers of vascular injury and VSMC activation in SVGs harvested using the pedicled ` no-touch ' ( NT ) vs the conventional ( CON ) technique .
-METHODS	Patients undergoing coronary artery bypass surgery were enrolled in the PATENT SVG trial ( clinicaltrials.gov NCT01488084 ) .
-METHODS	Patients were randomly allocated to have SVGs harvested with the NT technique from one leg and the CON method from the other .
-METHODS	SVG segments underwent morphometry , histological and electron microscopy assessments and transcript measurements of VSMC activation and differentiation markers .
-METHODS	Leg wound functional recovery and harvest site complications were assessed using a quality-of-life questionnaire .
-RESULTS	A total of 17 patients ( 65.3 7.3 years ) were enrolled .
-RESULTS	SVGs harvested using the NT vs CON technique exhibited preserved intimal , medial and adventitial architecture .
-RESULTS	CON harvest was associated with greater medial Kruppel-like factor 4 transcript levels ( 0.26 0.05 vs 0.11 0.02 , P < 0.05 ) .
-RESULTS	CON samples had significantly lower medial serum response factor ( 0.53 0.11 vs 1.44 0.50 , P < 0.05 ) and myocardin ( 0.59 0.08 vs 1.33 0.33 , P < 0.05 ) transcript levels .
-RESULTS	MicroRNA-145 , an inhibitor of VSMC activation and differentiation , was higher in the NT vs CON samples ( 1.84 1.03 vs 0.50 0.19 , P < 0.05 ) .
-RESULTS	Leg assessment scores were worse in the NT legs at 3 months , but similar to CON scores at 12 months .
-CONCLUSIONS	SVGs harvested using the ` NT ' technique exhibit an early molecular and morphological pattern consistent with decreased VSMC activation compared with CON harvesting .
-CONCLUSIONS	Functional leg recovery was similar in both groups at 12 months .
-CONCLUSIONS	Larger studies are required to corroborate these findings .
-
-###24330776
-BACKGROUND	The standard technique for the placement of ventricular catheters ( VC ) comprises a high proportion of malpositioning of the catheter ( 12.5 to 40 % ) .
-BACKGROUND	Technical advances such as neuronavigation or ultrasound have been shown to increase the accuracy of the procedure .
-BACKGROUND	Since these means result in significant technical and time consuming efforts , they are used for selected cases only .
-BACKGROUND	In order to simplify the controlled placement of ventricular catheters a newly developed smartphone assisted guiding tool has been introduced .
-BACKGROUND	In this study the efficacy and safety of this guiding tool is determined .
-METHODS	This study is a multicentre , randomised , controlled trial .
-METHODS	A total of 144 patients planned for an elective shunting procedure will be enrolled throughout 10 study centres within two years .
-METHODS	The primary objective of the trial is to show the superiority of the guided placement in comparison to the standard freehand technique of ventricular catheter application .
-METHODS	Patients will be followed up for 30 days after the operation in regard to image-based evaluation of the catheter position as well as possible shunt dysfunction and complications .
-CONCLUSIONS	The Guided Application of Ventricular Catheters ( GAVCA ) trial compares the guided catheter positioning with the standard freehand technique of catheter placement in hydrocephalic patients .
-CONCLUSIONS	If superiority is shown , the standard technique may be changed with the advantage of a more reliable and safer positioning of the ventricular catheter with just a slight effort in time and pre-operative planning .
-BACKGROUND	The GAVCA trial is registered at ClinicalTrials.gov under the number NCT01811589 .
-
-###25591555
-BACKGROUND	Angiotensin type 1 receptor ( AT 1 R ) antagonists are extensively used for blood pressure control in elderly patients with hypertension .
-BACKGROUND	This study aimed to investigate the inhibitory effects of AT 1 R antagonist valsartan on platelet aggregation and the occurrence of cardio-cerebral thrombotic events in elderly patients with hypertension .
-METHODS	Two-hundred and ten patients with hypertension and aged > 60 years were randomized to valsartan ( n = 140 ) or amlodipine ( n = 70 ) on admission .
-METHODS	The primary endpoint was platelet aggregation rate ( PAR ) induced by arachidonic acid at discharge , and the secondary endpoint was the rate of thrombotic events including brain infarction and myocardial infarction during follow-up .
-METHODS	Human aortic endothelial cells ( HAECs ) were stimulated by angiotensin II ( Ang II , 100 nmol/L ) with or without pretreatment of valsartan ( 100 nmol/L ) , and relative expression of cyclooxygenase-2 ( COX-2 ) and thromboxane B 2 ( TXB 2 ) and both p38 mitogen-activated protein kinase ( p38MAPK ) and nuclear factor-kB ( NF-kB ) activities were assessed .
-METHODS	Statistical analyses were performed by GraphPad Prism 5.0 software ( GraphPad Software , Inc. , California , USA ) .
-RESULTS	PAR was lower after treatment with valsartan ( 11.49 0.69 % vs. 18.71 2.47 % , P < 0.001 ) , associated with more reduced plasma levels of COX-2 ( 76.94 7.07 U/L vs. 116.4 15.89 U/L , P < 0.001 ) and TXB 2 ( 1667 56.50 pg/ml vs. 2207 180.20 pg/ml ) ( all P < 0.001 ) .
-RESULTS	Plasma COX-2 and TXB 2 levels correlated significantly with PAR in overall patients ( r = 0.109 , P < 0.001 ) .
-RESULTS	During follow-up ( median , 18 months ) , there was a significantly lower thrombotic event rate in patients treated with valsartan ( 14.3 % vs. 32.8 % , P = 0.002 ) .
-RESULTS	Relative expression of COX-2 and secretion of TXB 2 with concordant phosphorylation of p38MAPK and NF-kB were increased in HAECs when stimulated by Ang II ( 100 nmol/L ) but were significantly decreased by valsartan pretreatment ( 100 nmol/L ) .
-CONCLUSIONS	AT 1 R antagonist valsartan decreases platelet activity by attenuating COX-2 / TXA 2 expression through p38MAPK and NF-kB pathways and reduces the occurrence of cardio-cerebral thrombotic events in elderly patients with hypertension .
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-###24473536
-OBJECTIVE	Women with primary ovarian insufficiency ( POI ) display low androgen levels , which could contribute to mood and behavioral symptoms observed in this condition .
-OBJECTIVE	We examined the effects of physiologic testosterone therapy added to standard estrogen/progestin therapy on quality of life , self-esteem , and mood in women with POI .
-METHODS	One hundred twenty-eight women with 46 , XX spontaneous POI participated in a 12-month randomized , placebo-controlled , parallel-design investigation of the efficacy of testosterone augmentation of estrogen/progestin therapy .
-METHODS	Quality of life , self-esteem , and mood symptoms were evaluated with standardized rating scales and a structured clinical interview .
-METHODS	Differences in outcome measures between the testosterone and placebo treatments were analyzed by Wilcoxon rank sum tests .
-RESULTS	No differences in baseline characteristics , including serum hormone levels ( P > 0.05 ) , were found .
-RESULTS	Baseline mean ( SD ) Center for Epidemiologic Studies Depression Scale scores were 10.7 ( 8.6 ) and 9.2 ( 7.8 ) for testosterone and placebo , respectively ( P = 0.35 ) .
-RESULTS	After 12 months of treatment , measures of quality of life , self-esteem , and mood symptoms did not differ between treatment groups .
-RESULTS	Serum testosterone levels achieved physiologic levels in the testosterone group and were significantly higher compared with placebo ( P < 0.001 ) .
-RESULTS	Baseline testosterone levels were not associated with either adverse or beneficial clinical effects .
-CONCLUSIONS	A 150-g testosterone patch achieves physiologic hormone levels in women with POI .
-CONCLUSIONS	Our findings suggest that augmentation of standard estrogen/progestin therapy with physiologic testosterone therapy in young women with POI neither aggravates nor improves baseline reports of quality of life or self-esteem and had minimal effects on mood .
-CONCLUSIONS	Other mechanisms might play a role in the altered mood accompanying this disorder .
-
-###24282042
-BACKGROUND	Hospitalists have been shown to lower patient costs through better resource utilization and decreased length of stay , but it is unclear whether hospitalists are associated with quality of care .
-BACKGROUND	We examined the association between the presence of hospitalists and 30-day predicted excess all-cause hospital mortality and readmissions among Medicare patients admitted to a hospital with any of 3 conditions : heart failure , acute myocardial infarction , and pneumonia .
-METHODS	Using national hospital-level , case mix-adjusted , risk-standardized , 30-day all-cause excess mortality and readmission data from the Centers for Medicare and Medicaid Services , we used descriptive and bivariate statistics to illustrate trends across hospitals .
-METHODS	Using multivariable ordinary least squares regression to control for hospital-level characteristics , we then estimated the association between the presence of hospitalists and predicted hospital mortality and readmission .
-RESULTS	After multivariable adjustment , the presence of hospitalists was associated with lower probability of readmission for all 3 target conditions .
-RESULTS	No significant associations for any of the target conditions were found in all-cause mortality models .
-CONCLUSIONS	Hospitalists are already integral to the delivery of inpatient care at most institutions .
-CONCLUSIONS	This study , however , showed an association at the national level of the presence of hospitalists with an important and timely quality measure : reduction of readmission rates .
-CONCLUSIONS	Future research is indicated to explore specific causation pathways for the impact of hospitalists on quality of care .
-
-###24763475
-OBJECTIVE	To compare central corneal sublayer pachymetry and biomechanical properties after femtosecond lenticule extraction ( FLEX ) and small-incision lenticule extraction ( SMILE ) .
-METHODS	A prospective , randomized , single-masked clinical trial of 35 patients treated for moderate to high myopia with FLEX in one eye and SMILE in the other .
-METHODS	Anterior segment optical coherence tomography imaging ( Heidelberg Spectralis ; Heidelberg Engineering GmbH , Heidelberg , Germany ) was used to measure central corneal thickness ( CCT ) and epithelial , flap/cap , and residual stromal bed thickness centrally .
-METHODS	The Ocular Response Analyzer ( Reichert Ophthalmic Instruments , Buffalo , NY ) was used to assess corneal hysteresis ( CH ) and corneal resistance factor ( CRF ) .
-METHODS	Patients were examined before and 6 months after surgery .
-RESULTS	Mean decrease in CCT was 105 m in FLEX-treated eyes and 106 m in SMILE-treated eyes ( P = .70 ) , which is equivalent to approximately 14 m/diopters corrected .
-RESULTS	Mean central epithelial thickness increased 7 6 m in FLEX-treated eyes and 6 5 m in SMILE-treated eyes ( P = .64 ) .
-RESULTS	Achieved mean flap/cap thickness was 4 6 m from the expected thickness in FLEX-treated eyes and 4 9 m in SMILE-treated eyes ( P = .37 ) .
-RESULTS	CH was reduced 2.7 1.3 mm Hg in FLEX-treated eyes and 3.3 1.2 mm Hg in SMILE-treated eyes ( P = .08 ) .
-RESULTS	CRF was reduced 4.5 1.2 mm Hg in FLEX-treated eyes and 4.6 1.2 mm Hg in SMILE-treated eyes ( P = .71 ) .
-RESULTS	CH and CRF were highly correlated with CCT , but not patient age .
-CONCLUSIONS	In this paired-eye study , the flap-based FLEX and cap-based SMILE resulted in almost identical changes in central corneal sublayer pachymetry and biomechanical properties for moderate to high myopia 6 months after treatment .
-
-###25187423
-BACKGROUND	Smokers have a lower body weight compared to non-smokers .
-BACKGROUND	Smoking cessation is associated with weight gain in most cases .
-BACKGROUND	A hormonal mechanism of action might be implicated in weight variations related to smoking , and leptin might be implicated .
-BACKGROUND	We made secondary analyses of an RCT , with a hypothesis-free exploratory approach to study the dynamic of leptin following smoking cessation .
-METHODS	We measured serum leptin levels among 271 sedentary smokers willing to quit who participated in a randomized controlled trial assessing a 9-week moderate-intensity physical activity intervention as an aid for smoking cessation .
-METHODS	We adjusted leptin for body fat levels .
-METHODS	We performed linear regressions to test for an association between leptin levels and the study group over time .
-RESULTS	One year after smoking cessation , the mean serum leptin change was +3.23 mg/l ( SD 4.89 ) in the control group and +1.25 mg/l ( SD 4.86 ) in the intervention group ( p of the difference < 0.05 ) .
-RESULTS	When adjusted for body fat levels , leptin was higher in the control group than in the intervention group ( p of the difference < 0.01 ) .
-RESULTS	The mean weight gain was +2.91 ( SD 6.66 ) Kg in the intervention and +3.33 ( SD 4.47 ) Kg in the control groups , respectively ( p not significant ) .
-CONCLUSIONS	Serum leptin levels significantly increased after smoking cessation , in spite of substantial weight gain .
-CONCLUSIONS	The leptin dynamic might be different in chronic tobacco users who quit smoking , and physical activity might impact the dynamic of leptin in such a situation .
-CONCLUSIONS	Clinical trial registration number : NCT00521391 .
-
-###25885923
-BACKGROUND	Low-income black residents of Baltimore City have disproportionately higher rates of obesity and chronic disease than other Maryland residents .
-BACKGROUND	Increasing the availability and affordability of healthy food are key strategies to improve the food environment and can lead to healthier diets .
-BACKGROUND	This paper describes B'More Healthy : Retail Rewards ( BHRR ) , an intervention that tests the effectiveness of performance-based pricing discounts and health communications , separately and combined , on healthy food purchasing and consumption among low-income small store customers .
-METHODS	BHRR is 2x2 factorial design randomized controlled trial .
-METHODS	Fifteen regular customers recruited from each of 24 participating corner stores in Baltimore City were enrolled .
-METHODS	Food stores were randomized to 1 ) pricing intervention , 2 ) communications intervention , 3 ) combined intervention , or 4 ) control .
-METHODS	Pricing stores were given a 10-30 % price discount on selected healthier food items , such as fresh fruits , frozen vegetables , and baked chips , at the point of purchase from two food wholesale stores during the 6-month trial .
-METHODS	Storeowners agreed to pass on the discount to the consumer to increase demand for healthy food .
-METHODS	Communications stores received visual and interactive materials to promote healthy items , including signage , taste tests , and refrigerators .
-METHODS	Primary outcome measures include consumer food purchasing and associated psychosocial variables .
-METHODS	Secondary outcome measures include consumer food consumption , store sales , and associated storeowner psychosocial factors .
-METHODS	Process evaluation was monitored throughout the trial at wholesaler , small store , and consumer levels .
-CONCLUSIONS	This is the first study to test the impact of performance-based pricing and communications incentives in small food stores , an innovative strategy to encourage local wholesalers and storeowners to share responsibility in creating a healthier food supply by stocking , promoting , and reducing costs of healthier foods in their stores .
-CONCLUSIONS	Local food wholesalers were involved in a top-down , participatory approach to develop and implement an effective and sustainable program .
-CONCLUSIONS	This study will provide evidence on the effectiveness of price incentives and health communications , separately and combined , among a low-income urban U.S.
-BACKGROUND	ClinicalTrials.gov : NCT02279849 ( 2/18/2014 ) .
-
-###24745666
-BACKGROUND	Loxapine , a first-generation antipsychotic , delivered with a novel inhalation delivery device developed for the acute treatment of agitation in patients with schizophrenia or bipolar disorder was evaluated in subjects with asthma or chronic obstructive pulmonary disease ( COPD ) .
-METHODS	Separate randomized , double-blind , parallel-arm , placebo-controlled trials compared two administrations of inhaled loxapine ( 10mg ) 10hr apart with placebo in 52 subjects with asthma and in 53 subjects with COPD .
-METHODS	A thermally-generated drug aerosol of loxapine was delivered to the deep lung for rapid systemic absorption .
-METHODS	Controller medications were continued throughout the study , but quick-relief bronchodilators were withheld from 6-8hr before through 34hr after dose 1 , unless indicated as rescue .
-RESULTS	All airway adverse events ( AEs ) were of mild or moderate severity .
-RESULTS	Symptomatic bronchospasm occurred in 53.8 % of subjects with asthma after inhaled loxapine and 11.5 % after placebo ; and in 19.2 % of COPD subjects after inhaled loxapine and 11.1 % after placebo .
-RESULTS	Subjects required inhaled albuterol as follows : asthma : 53.8 % after inhaled loxapine and 11.5 % after placebo ; and COPD : 23.1 % after inhaled loxapine and 14.8 % after placebo .
-RESULTS	Respiratory signs/symptoms requiring treatment responded to rescue bronchodilator [ forced expiratory volume in 1sec ( FEV ( 1 ) ) return to within 10 % of baseline ] within 1hr in 11 of 15 events in asthma subjects and four of seven events in COPD subjects , the remainder by the last spirometry .
-CONCLUSIONS	In subjects with either asthma or COPD , FEV ( 1 ) decline and bronchospasm can occur following inhaled loxapine , but more frequently in asthmatic subjects .
-CONCLUSIONS	Most subjects with bronchospasm responded to rescue bronchodilator within 1hr .
-CONCLUSIONS	No treatment-related serious AE occurred .
-CONCLUSIONS	Although inhaled loxapine is contraindicated in patients with active airways disease per the current approved US labeling , these studies demonstrated that rescue bronchodilator mitigated the symptomatic bronchospasms that may occur in case of inadvertent use .
-
-###25119686
-BACKGROUND	Forced expiratory volume in 1s/forced expiratory volume in 6s ( FEV1/FEV6 ) assessment with a microspirometer may be useful in the diagnostic work up of subjects who are suspected of having COPD in primary care .
-OBJECTIVE	To determine the diagnostic accuracy of a negative pre-bronchodilator ( BD ) microspirometry test relative to a full diagnostic spirometry test in subjects in whom general practitioners ( GPs ) suspect airflow obstruction .
-METHODS	Cross-sectional study in which the order of microspirometry and diagnostic spirometry tests was randomised .
-METHODS	Study subjects were ( ex - ) smokers aged 50 years referred for diagnostic spirometry to a primary care diagnostic centre by their GPs .
-METHODS	A pre-BD FEV1/FEV6 value < 0.73 as measured with the PiKo-6 microspirometer was compared with a post-BD FEV1/FVC ( forced vital capacity ) < 0.70 and FEV1/FVC < lower limit of normal ( LLN ) from diagnostic spirometry .
-RESULTS	One hundred and four subjects were analysed ( 59.6 % males , 42.3 % current smokers ) .
-RESULTS	Negative predictive values from microspirometry for airflow obstruction based on the fixed and LLN cut-off points were 94.4 % ( 95 % confidence interval ( CI ) , 86.4-98 .5 ) and 96.3 % ( 95 % CI , 88.2-99 .3 ) , respectively .
-RESULTS	In all , 18 % of positive microspirometry results were not confirmed by a post-BD FEV1/FVC < 0.70 and 44 % of tests were false positive compared with the LLN criterion for airflow obstruction .
-CONCLUSIONS	Pre-bronchodilator microspirometry seems to be able to reliably preselect patients for further assessment of airflow obstruction by means of regular diagnostic spirometry .
-CONCLUSIONS	However , use of microspirometry alone would result in overestimation of airflow obstruction and should not replace regular spirometry when diagnosing COPD in primary care .
-
-###24355993
-OBJECTIVE	Older patients with a distal symmetric polyneuropathy are at markedly increase risk for falls and fall-related injuries .
-OBJECTIVE	Despite this , few studies have investigated the effect of exercise regimens on gait and balance in this high-risk group .
-METHODS	One hundred older patients with distal symmetric polyneuropathy were randomized to one of three interventions : functional balance training , Tai Chi , or education-only control .
-METHODS	The subjects in each group received instruction in ten 1-hr weekly sessions .
-METHODS	Outcome measures were determined at baseline and the end of the 10-wk intervention .
-METHODS	Gait , balance , and falls self-efficacy were assessed with various well established clinical ( Berg Balance Scale , 8 Foot Up and Go Test , and Modified Falls Efficacy Scale ) and laboratory-based measures ( three-dimensional gait analysis and NeuroCom limits of stability and sensory organization tests ) .
-RESULTS	The Tai Chi subjects demonstrated a decreased ( faster ) Timed Up and Go and increased stride length and time spent in single limb support at the end of intervention as compared with baseline .
-RESULTS	The functional balance training group demonstrated a significant increase in ankle plantar flexor power and near significant decreases in step width and step width variability .
-RESULTS	No changes in the education-only control group were observed .
-CONCLUSIONS	Older patients with distal symmetric polyneuropathy may benefit from Tai Chi and/or functional balance training , with the former improving functional mobility and gait and the latter possibly improving trunk stabilization and forward progression ( Lythgo N , Cofr LE : Relationship between ankle plantar flexor power and EMG muscle activity during gait .
-CONCLUSIONS	30th Annual Conference of Biomechanics in Sports [ Melbourne , 2012 ] .
-CONCLUSIONS	Available at : https://ojs.ub.uni-konstanz.de/cap/article/viewFile/5320/4891 ) .
-CONCLUSIONS	Whether these laudable changes can be maintained or translate into decreased risk for falls and fall-related injuries is unknown .
-
-###24477367
-OBJECTIVE	There are limited data on the role of antireflux biliary stents .
-OBJECTIVE	This single-center randomized trial compared the endoscopic use of partly covered antireflux metal stents ( pcARMS ) with that of standard uncovered self-expandable metal stents ( ucSEMS ) for the palliation of nonhilar malignant biliary obstruction .
-METHODS	Between August 2007 and February 2012 , patients with nonhilar malignant biliary obstruction were randomly assigned to treatment with either pcARMS or ucSEMS.Subsequent follow-up was conducted in clinic or by phone .
-METHODS	The primary outcome was onset of cholangitis within 12 months of stenting .
-METHODS	Secondary outcomes included other morbidities , stent dysfunctions , and survival .
-RESULTS	Altogether 112 patients were included , 56 in each group.The stents were successfully deployed in all patients .
-RESULTS	Satisfactory jaundice control was achieved in 49 cases in the pcARMS group , compared with 47 in the ucSEMS group ( P = 0.135 ) .
-RESULTS	Fewer patients experienced cholangitis in the pcARMS group than in the ucSEMS group ( 10 vs. 21 patients ; P = 0.035 ) , and the frequency of episodes was less ( P = 0.022 ) .
-RESULTS	Respectively , 17 and 29 stent dysfunctions before death were observed in the pcARMS and ucSEMS groups ( P = 0.051 ) and the median stent patency was 13.0 ( standard deviation [ SD ] 3.4 ) and 10.0 ( 1.2 ) months , respectively ( P = 0.044 ) .
-RESULTS	At final follow-up , in January 2013 , 50/52 and 52/55 patients had died and no difference in median survival was seen between the two groups ( 8.0 vs. 9.0 months , P = 0.56 ) .
-CONCLUSIONS	Stenting with pcARMS compared with standard ucSEMS reduces risk of ascending cholangitis and has longer stent patency , but does not increase patient survival .
-CONCLUSIONS	Chictr.org .
-CONCLUSIONS	number , ChiCTR-TRC-11001800 .
-
-###25402757
-OBJECTIVE	Coronary artery disease ( CAD ) is a major cause of cardiovascular morbidity and mortality in patients with diabetes mellitus , yet CAD often is asymptomatic prior to myocardial infarction ( MI ) and coronary death .
-OBJECTIVE	To assess whether routine screening for CAD by coronary computed tomography angiography ( CCTA ) in patients with type 1 or type 2 diabetes deemed to be at high cardiac risk followed by CCTA-directed therapy would reduce the risk of death and nonfatal coronary outcomes .
-METHODS	The FACTOR-64 study was a randomized clinical trial in which 900 patients with type 1 or type 2 diabetes of at least 3 to 5 years ' duration and without symptoms of CAD were recruited from 45 clinics and practices of a single health system ( Intermountain Healthcare , Utah ) , enrolled at a single-site coordinating center , and randomly assigned to CAD screening with CCTA ( n = 452 ) or to standard national guidelines-based optimal diabetes care ( n = 448 ) ( targets : glycated hemoglobin level < 7.0 % , low-density lipoprotein cholesterol level < 100 mg/dL , systolic blood pressure < 130 mm Hg ) .
-METHODS	All CCTA imaging was performed at the coordinating center .
-METHODS	Standard therapy or aggressive therapy ( targets : glycated hemoglobin level < 6.0 % , low-density lipoprotein cholesterol level < 70 mg/dL , high-density lipoprotein cholesterol level > 50 mg/dL [ women ] or > 40 mg/dL [ men ] , triglycerides level < 150 mg/dL , systolic blood pressure < 120 mm Hg ) , or aggressive therapy with invasive coronary angiography , was recommended based on CCTA findings .
-METHODS	Enrollment occurred between July 2007 and May 2013 , and follow-up extended to August 2014 .
-METHODS	The primary outcome was a composite of all-cause mortality , nonfatal MI , or unstable angina requiring hospitalization ; the secondary outcome was ischemic major adverse cardiovascular events ( composite of CAD death , nonfatal MI , or unstable angina ) .
-RESULTS	At a mean follow-up time of 4.0 ( SD , 1.7 ) years , the primary outcome event rates were not significantly different between the CCTA and the control groups ( 6.2 % [ 28 events ] vs 7.6 % [ 34 events ] ; hazard ratio , 0.80 [ 95 % CI , 0.49-1 .32 ] ; P = .38 ) .
-RESULTS	The incidence of the composite secondary end point of ischemic major adverse cardiovascular events also did not differ between groups ( 4.4 % [ 20 events ] vs 3.8 % [ 17 events ] ; hazard ratio , 1.15 [ 95 % CI , 0.60-2 .19 ] ; P = .68 ) .
-CONCLUSIONS	Among asymptomatic patients with type 1 or type 2 diabetes , use of CCTA to screen for CAD did not reduce the composite rate of all-cause mortality , nonfatal MI , or unstable angina requiring hospitalization at 4 years .
-CONCLUSIONS	These findings do not support CCTA screening in this population .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00488033 .
-
-###25575502
-OBJECTIVE	Using the Oslo Study of 1972-1973 , we wished to compare the long-term mortality pattern up to 40 years , in both the healthy cardiovascular groups at supposedly high and low risk , and in some groups having cardiovascular disease at screening .
-METHODS	At the screening , 16,203 ( 63 % of those invited ) men aged 40-49 years participated .
-METHODS	Study groups were identified by means of questionnaires regarding diseases , blood pressure and measurements of total cholesterol , triglycerides and glucose .
-METHODS	We identified six groups : very high cholesterol , very high blood pressure , very high glucose , non-smoking with non-elevated such risk factors , from a randomized diet and antismoking trial , and a randomized drug treatment in mild-to-moderate hypertension .
-METHODS	Statistical analyses were by Cox regression analysis , with Kaplan-Meier graphs .
-RESULTS	The supposedly low-risk group had a total mortality of one-third of other groups , such as : men with hypertension , diabetes or hypercholesterolemia , or those whom participated in the two trials .
-RESULTS	Between these latter groups , we found 2-5 years of difference in their median survival time , but their absolute risk stayed at rather high levels through all the years , with the median remaining a lifetime that was 3-8 years shorter than the men whom were free of known cardiovascular disease , diabetes or hypertension .
-CONCLUSIONS	The long-term preventive effects on total mortality seem large , if the levels of the classical risk factors of blood pressure , total cholesterol and glucose can be adequately controlled , concurrently with a non-smoking behavior .
-CONCLUSIONS	The study indicated that non-smoking and a low total cholesterol value were the most important contributors to extended survival .
-
-###25337748
-BACKGROUND	Shortening the course of treatment for tuberculosis would be a major improvement for case management and disease control .
-BACKGROUND	This phase 3 trial assessed the efficacy and safety of a 4-month gatifloxacin-containing regimen for treating rifampin-sensitive pulmonary tuberculosis .
-METHODS	We conducted a noninferiority , randomized , open-label , controlled trial involving patients 18 to 65 years of age with smear-positive , rifampin-sensitive , newly diagnosed pulmonary tuberculosis in five sub-Saharan African countries .
-METHODS	A standard 6-month regimen that included ethambutol during the 2-month intensive phase was compared with a 4-month regimen in which gatifloxacin ( 400 mg per day ) was substituted for ethambutol during the intensive phase and was continued , along with rifampin and isoniazid , during the continuation phase .
-METHODS	The primary efficacy end point was an unfavorable outcome ( treatment failure , recurrence , or death or study dropout during treatment ) measured 24 months after the end of treatment , with a noninferiority margin of 6 percentage points , adjusted for country .
-RESULTS	A total of 1836 patients were assigned to the 4-month regimen ( experimental group ) or the standard regimen ( control group ) .
-RESULTS	Baseline characteristics were well balanced between the groups .
-RESULTS	At 24 months after the end of treatment , the adjusted difference in the risk of an unfavorable outcome ( experimental group [ 21.0 % ] minus control group [ 17.2 % ] ) in the modified intention-to-treat population ( 1356 patients ) was 3.5 percentage points ( 95 % confidence interval , -0.7 to 7.7 ) .
-RESULTS	There was heterogeneity across countries ( P = 0.02 for interaction , with differences in the rate of an unfavorable outcome ranging from -5.4 percentage points in Guinea to 12.3 percentage points in Senegal ) and in baseline cavitary status ( P = 0.04 for interaction ) and body-mass index ( P = 0.10 for interaction ) .
-RESULTS	The standard regimen , as compared with the 4-month regimen , was associated with a higher dropout rate during treatment ( 5.0 % vs. 2.7 % ) and more treatment failures ( 2.4 % vs. 1.7 % ) but fewer recurrences ( 7.1 % vs. 14.6 % ) .
-RESULTS	There was no evidence of increased risks of prolongation of the QT interval or dysglycemia with the 4-month regimen .
-CONCLUSIONS	Noninferiority of the 4-month regimen to the standard regimen with respect to the primary efficacy end point was not shown .
-CONCLUSIONS	( Funded by the Special Program for Research and Training in Tropical Diseases and others ; ClinicalTrials.gov number , NCT00216385 . )
-
-###24366350
-BACKGROUND	Malaria infections are the leading cause of death for children in Madagascar .
-BACKGROUND	Insecticide-treated bednets offer effective prevention , but it is unclear how well free bednet distribution programs reach young children .
-METHODS	We conducted a secondary analysis of a free bednet distribution program in Madagascar from 2007-2008 .
-METHODS	Interviews were performed at baseline and 6 months .
-METHODS	Principal components analysis was used to construct a wealth and malaria knowledge index .
-METHODS	Coverage efficiency was calculated as coverage of children per bednet owned .
-METHODS	Univariable and multivariable regressions were used to determine predictors of bednet use .
-RESULTS	Bednet use , among the 560 households in the study , increased from 6 to 91 % after 6 months .
-RESULTS	Coverage efficiency increased from 1.29 to 1.56 children covered per bednet owned .
-RESULTS	In multivariable analysis , having a child under 5 years of age was the only variable associated with bednet use ( OR 9.10 ; p = 0.001 ) , yielding a 99 % likelihood of using a bednet ( 95 % CI 96.4 to 99.9 % ) versus 82 % ( 95 % CI 72.2 to 88.4 % ) in households without young children .
-CONCLUSIONS	This free bednet distribution program achieved high levels of adherence after 6 months .
-CONCLUSIONS	Household presence of children was associated with bednet use , but not household income or education , suggesting that distribution to priority groups may help overcome traditional barriers to adoption in some settings .
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-###24789668
-OBJECTIVE	To assess health-related quality of life ( HRQOL ) of subjects at risk of type 2 diabetes undergoing lifestyle intervention , and predictors for improved HRQOL .
-METHODS	The Finnish Diabetes Risk Score was used by general practitioners to identify individuals at risk .
-METHODS	Low-intensity interventions with an 18-month follow-up were employed .
-METHODS	HRQOL was assessed using the SF-36 at baseline and compared with results from a general Norwegian population survey and further at 6 and 18 months .
-METHODS	Simple and multiple linear regression analyses were applied to identify predictors of changes in HRQOL of clinical importance .
-RESULTS	Two hundred and thirteen participants ( 50 % women ; mean age : 46 years , mean body mass index : 37 ) were included : 182 returned for 18-month follow-up , of whom 172 completed the HRQOL questionnaire .
-RESULTS	HRQOL was reduced with clinical significance compared with general Norwegians .
-RESULTS	The mean changes in HRQOL from the baseline to the follow-up were not of clinical importance .
-RESULTS	However , one out of three individuals achieved a moderate or large clinical improvement in HRQOL .
-RESULTS	The best determinant for improved HRQOL was obtained for a composite , clinically significant lifestyle change , i.e. both a weight reduction of at least 5 % and an improvement in exercise capacity of at least 10 % , which was associated with an improvement in five out of the eight SF-36 domains .
-CONCLUSIONS	Subjects at risk of type 2 diabetes report a clinically important reduction in HRQOL compared with general Norwegians .
-CONCLUSIONS	The best predictor of improved HRQOL was a small weight loss combined with a small improvement in aerobic capacity .
-
-###26258455
-BACKGROUND	The Nintendo Wii is a simple and affordable virtual therapy alternative .
-BACKGROUND	It may be used at home , and it is a motivating recreational activity that provides continuous feedback .
-BACKGROUND	However , studies comparing the use of the Nintendo Wii to conventional physical therapy are needed .
-OBJECTIVE	To compare the effect of a rehabilitation treatment using the Nintendo Wii ( NW ) with conventional physical therapy ( CPT ) to improve the sensorimotor function and quality of life for post-stroke hemiparetic patients .
-METHODS	The present study applied a randomized , blind , and controlled clinical trial .
-METHODS	In total , 30 patients with post-stroke hemiparesis were evaluated .
-METHODS	A total of 15 patients were randomly assigned to each group .
-METHODS	The SF-36 quality of life and Fugl-Meyer scales were used to evaluate the patients .
-RESULTS	After treatment , the only variable that differed between the groups was the physical functioning domain of the SF-36 in the group that received conventional physical therapy .
-RESULTS	A significant difference was observed between both groups before and after treatment in terms of the following Fugl-Meyer scale items : passive movement and pain , motor function of the upper limbs ( ULs ) , and balance .
-RESULTS	The CPT group also showed a significant difference with regard to their UL and lower limb ( LL ) coordination .
-RESULTS	The SF-36 scale analysis revealed a significant difference within both groups with regard to the following domains : physical functioning , role limitation due to physical aspects , vitality , and role limitation due to emotional aspects .
-RESULTS	The NW group also exhibited a significant difference in the mental health domain .
-RESULTS	The results indicate that both approaches improved the patients ' performance in a similar manner .
-CONCLUSIONS	Virtual rehabilitation using the Nintendo Wii and CPT both effectively treat post-stroke hemiparetic patients by improving passive movement and pain scores , motor function of the upper limb , balance , physical functioning , vitality , and the physical and emotional aspects of role functioning .
-
-###24342115
-OBJECTIVE	The aims were to examine the effects of psychotherapy on depressive and anxiety symptoms , the occurrence of suicidal ideations and diurnal cortisol patterns in patients with adjustment disorder ( AD ) with depressed mood .
-METHODS	Participants recruited from an outpatient department of psychiatry at a general hospital were randomly assigned to one of two groups : 34 in psychotherapy group and 37 in control group .
-METHODS	The control group consisted of one-session psychoeducation .
-METHODS	Psychotherapy included the eight-weekly body-mind-spirit ( BMS ) group psychotherapy .
-METHODS	Measures included Beck Depression Inventory-II and State Trait Anxiety Inventory .
-METHODS	Salivary cortisol samples were collected from the patients at their homes on awakening ; 30 and 45 min after awakening ; and at 1200 , 1700 and 2100 h. Measurements were taken at baseline and at months 2 ( end of intervention ) , 5 , 8 and 14 .
-RESULTS	There was no differential change over time between the BMS and control groups in self-reported depression or anxiety symptoms .
-RESULTS	However , suicidal ideation appeared to be reduced in the psychotherapy group .
-RESULTS	Changes in diurnal cortisol patterns were also significantly different in group time interactions , in favor of BMS group .
-CONCLUSIONS	Psychotherapy likely provides improvements in psychobiological stress responses and decreases the occurrence of suicidal ideation in patients with AD .
-
-###24508042
-BACKGROUND	In this paper , we review the results of existing statistical models of the long-term persistence of hepatitis A vaccine-induced antibodies in light of recently available immunogenicity data from 2 clinical trials ( up to 17 years of follow-up ) .
-METHODS	Healthy adult volunteers monitored annually for 17 years after the administration of the first vaccine dose in 2 double-blind , randomized clinical trials were included in this analysis .
-METHODS	Vaccination in these studies was administered according to a 2-dose vaccination schedule : 0 , 12 months in study A and 0 , 6 months in study B ( NCT00289757/NCT00291876 ) .
-METHODS	Antibodies were measured using an in-house ELISA during the first 11 years of follow-up ; a commercially available ELISA was then used up to Year 17 of follow-up .
-METHODS	Long-term antibody persistence from studies A and B was estimated using statistical models for longitudinal data .
-METHODS	Data from studies A and B were modeled separately .
-RESULTS	A total of 173 participants in study A and 108 participants in study B were included in the analysis .
-RESULTS	A linear mixed model with 2 changepoints allowed all available results to be accounted for .
-RESULTS	Predictions based on this model indicated that 98 % ( 95 % CI : 94-100 % ) of participants in study A and 97 % ( 95 % CI : 94-100 % ) of participants in study B will remain seropositive 25 years after receiving the first vaccine dose .
-RESULTS	Other models using part of the data provided consistent results : 95 % of the participants was projected to remain seropositive for 25 years .
-CONCLUSIONS	This analysis , using previously used and newly selected model structures , was consistent with former estimates of seropositivity rates 95 % for at least 25 years .
-
-###24859410
-OBJECTIVE	The ultrasonic scalpel is a surgical shear that uses high-frequency mechanical energy to enable simultaneous vessel sealing and tissue coagulation at the same time .
-OBJECTIVE	We conducted a prospective study to compare the outcome of total thyroidectomy using the ultrasonic scalpel versus the device Ligasure in terms of safety , operative time , overall drainage volume , complications , hospital stay .
-METHODS	Between January 2008 and December 2013,400 patients ( 260 women , 140 men ; mean age 46 years ) undergoing thyroidectomy were randomized into two groups : group A , where Ultracision were used , and group B , where the Ligasure device was used .
-RESULTS	There was no significant differences between the two groups in terms of age , gender , indication for thyroidectomy , thyroid gland weight and diameter , histopathologic diagnosis , preoperative and postoperative serum calcium levels , postoperative complications and reoperative thyroid surgery , time of operation and amount of drainage .
-CONCLUSIONS	The ultrasonic scalpel and the Ligasure ares safe , effective , useful , and time-saving alternative to the traditional suture ligation technique for thyroid surgery .
-CONCLUSIONS	They simplified total thyroidectomy , eliminating the need for clamp-and-tie maneuvers while achieving efficient hemostasis .
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-###25546052
-OBJECTIVE	To determine the effect of topical intranasal oxymetazoline on nasal resistance and aerobic exercise performance in patients with nasal congestion caused by inferior turbinate hypertrophy .
-METHODS	Individual randomized controlled trial .
-METHODS	Eight patients with inferior turbinate hypertrophy performed a set of exercise tests to exhaustion 1 week apart .
-METHODS	They were given oxymetazoline or a placebo before each of the two test sessions according to a random pattern .
-METHODS	Changes in nasal airflow were measured as peak nasal flow and ventilatory efficiency parameters , ventilatory equivalents , end-expiratory pressure , oxygen consumption , cardiac efficiency , rate of perceived exertion , and maximal and submaximal mechanical power .
-RESULTS	Ten minutes after use of the drug or placebo , improvements in maximum nasal airflow were seen in the oxymetazoline group ( P < 0.05 ) .
-RESULTS	However , exercise tests showed improvements in both groups ( P < 0.05 ) .
-RESULTS	After exertion , there was no difference between the two groups in maximum nasal airflow ( P > 0.05 ) .
-RESULTS	There were no differences between groups in oxygen consumption , rate of perceived exertion , respiratory exchange ratio , ventilation , or ventilatory equivalents for oxygen .
-CONCLUSIONS	Oxymetazoline increased nasal airflow in patients with turbinate hypertrophy , but this change did not translate into gains in physical exercise parameters or perceived exertion .
-METHODS	1b .
-
-###25033066
-BACKGROUND	Fibrous dysplasia ( FD ) is a rare skeletal disorder , resulting in deformity , fracture , functional impairment , and pain .
-BACKGROUND	Bisphosphonates have been advocated as a potential treatment .
-OBJECTIVE	To determine the efficacy of alendronate for treatment of FD .
-METHODS	Two-year randomized , double-blind , placebo-controlled trial .
-METHODS	Clinical research center .
-METHODS	Forty subjects with polyostotic FD ( 24 adults , 16 children ) .
-METHODS	Subjects were randomized and stratified by age .
-METHODS	Study drug was administered over a 24 month period in 6 month cycles ( 6 months on , 6 months off ) .
-METHODS	Alendronate dosing was stratified : 40 mg daily for subjects > 50 kg , 20 mg for 30-50 kg , 10 mg for 20-30 kg .
-METHODS	Primary endpoints were bone turnover markers , including serum osteocalcin , and urinary NTX-telopeptides .
-METHODS	Secondary endpoints included areal bone mineral density ( aBMD ) , pain , skeletal disease burden score , and functional parameters including the 9-min walk test and manual muscle testing .
-RESULTS	Clinical data was collected on 35 subjects who completed the study .
-RESULTS	There was a decline in NTX-telopeptides in the alendronate group ( P = .006 ) , but no significant difference in osteocalcin between groups .
-RESULTS	The alendronate group had an increase in areal BMD in normal bone at the lumbar spine ( P = .006 ) , and in predetermined regions of FD ( P < .001 ) .
-RESULTS	There were no significant differences in pain scores , skeletal disease burden scores , or functional parameters between the groups .
-CONCLUSIONS	Alendronate treatment led to a reduction in the bone resorption marker NTX-telopeptides , and improvement in aBMD , but no significant effect on serum osteocalcin , pain , or functional parameters .
-
-###25995489
-BACKGROUND	The optimal postoperative analgesia after primary total hip arthroplasty remains in question .
-BACKGROUND	This randomized , double-blind , placebo-controlled study compared the use of patient-controlled epidural analgesia ( PCEA ) with use of a multimodal pain regimen including periarticular injection ( PAI ) .
-BACKGROUND	We hypothesized that PAI would lead to earlier readiness for discharge , decreased opioid consumption , and lower pain scores .
-METHODS	Forty-one patients received PAI , and forty-three patients received PCEA .
-METHODS	Preoperatively , both groups were administered dexamethasone ( 6 mg , orally ) .
-METHODS	The PAI group received a clonidine patch and sustained-release oxycodone ( 10 mg ) , while the PCEA group had placebo .
-METHODS	Both groups received combined spinal-epidural anesthesia and used an epidural pain pump postoperatively ; the PAI group had normal saline solution , while the PCEA group had bupivacaine and hydromorphone .
-METHODS	The primary outcome , readiness for discharge , required the discontinuation of the epidural , a pain score of < 4 ( numeric rating scale ) without parenteral narcotics , normal eating , minimal nausea , urination without a catheter , a dry surgical wound , no acute medical problems , and the ability to independently transfer and walk 12.2 m ( 40 ft ) .
-RESULTS	The mean time to readiness for discharge ( and standard deviation ) was 2.4 0.7 days ( PAI ) compared with 2.3 0.8 days ( PCEA ) ( p = 0.86 ) .
-RESULTS	The mean length of stay was 3.0 0.8 days ( PAI ) compared with 3.1 0.7 days ( PCEA ) ( p = 0.46 ) .
-RESULTS	A significant mean difference in pain score of 0.74 with ambulation ( p = 0.01 ; 95 % confidence interval [ CI ] , 0.18 to 1.31 ) and 0.80 during physical therapy ( p = 0.03 ; 95 % CI , 0.09 to 1.51 ) favored the PCEA group .
-RESULTS	The mean opioid consumption ( oral morphine equivalents in milligrams ) was significantly higher in the PAI group on postoperative day 0 ( 43 21 compared with 28 23 ; p = 0.002 ) and postoperative days 0 through 2 ( 136 59 compared with 90 79 ; p = 0.004 ) .
-RESULTS	Opioid-Related Symptom Distress Scale ( ORSDS ) composite scores for severity and bothersomeness as well as scores for nausea , vomiting , and itchiness were significantly higher in the PCEA group ( p < 0.05 ) .
-RESULTS	Quality of Recovery-40 scores and patient satisfaction were similar .
-CONCLUSIONS	PAI did not decrease the time to discharge and was associated with higher pain scores and greater opioid consumption but lower ORSDS scores compared with PCEA .
-CONCLUSIONS	The choice for analgesic regimen may depend on a particular patient 's threshold for pain and the potential side effects .
-
-###24387127
-OBJECTIVE	Benefits of the skeletonized internal thoracic artery ( ITA ) include increased graft flow , increased graft length , and reduced incidence of sternal complications .
-OBJECTIVE	We conducted a randomized , double-blinded comparison of skeletonized versus pedicled ITA to assess the differences in pain intensity and extent of disability between the two types of harvesting procedures at one and three months follow-up .
-METHODS	A total of 50 patients were included in our study .
-METHODS	Twenty-five patients had undergone skeletonized grafting while the other half had undergone pedicled grafting .
-METHODS	The patients were evaluated for their pain at one and three months postoperatively .
-METHODS	Extent of disability was measured via Pain Disability Index and intensity of pain was measured via Visual Analogue Scale ( VAS ) .
-METHODS	The patients were also questioned about the details of their pain using Short Form McGill Pain Questionnaire .
-RESULTS	In the first month , the mean pain intensity measured through VAS was 30.44.0 and 55.05.7 mm in skeletonized and pedicle group , respectively .
-RESULTS	The pedicled group had significantly higher scores measured by all three scales at both one - and three-month intervals ( p-values < 0.0001 ) .
-CONCLUSIONS	Our results indicate that skeletonization of ITA significantly reduces postcoronary artery bypass graft surgery pain at both one - and three-month intervals .
-CONCLUSIONS	Long-term clinical trials involving larger sample sizes should be conducted to fully confirm the benefits of the skeletonization technique .
-
-###24834772
-BACKGROUND	Allergen-specific immunotherapy ( SIT ) is the only intervention for IgE-mediated respiratory disorders .
-OBJECTIVE	The aim of the study was to investigate the immunological modifications induced by SIT in patients allergic to olive and/or grass pollen by attempting to establish an association between these modifications and clinical improvements .
-METHODS	We studied 29 patients who were allergic to olive and/or grass pollen .
-METHODS	Patients were randomized to 2 groups : an active treatment group , comprising 19 allergic patients who received SIT , and a control group , formed by 10 allergic patients who received pharmacological treatment for their allergic symptoms but not immunotherapy .
-METHODS	We used flow cytometry to analyze intracellular expression of the cytokines IL-4 , IFN-gamma , IL-10 , and TGF-beta1 in CD4 + T cells , as well as expression of Foxp3 , the costimulatory CTLA-4 molecule , and the non-costimulatory CD40L molecule .
-METHODS	To assess clinical changes , patients recorded their medication consumption , symptoms , and the limitation of daily activities using diary cards and quality of life questionnaires .
-RESULTS	Six months after initiation of SIT , we recorded a reduction in cell surface CD40L expression in the CD4 + T-cell population and a shift in the cytokine production profile ( decrease in IL-4-producing CD4 + T cells and increase in IFN-gamma , IL-10 , and TGF-beta1 ) .
-RESULTS	These changes persisted after 12 months .
-RESULTS	Simultaneously , a clinical improvement was observed .
-CONCLUSIONS	SIT-induced clinical improvement is the result of immunological modifications such as a reduction in CD40L expression on CD4 cells and alteration in the cytokine production profile .
-
-###25553511
-BACKGROUND	The luteal menstrual phase might be a favorable time for smoking cessation when non-nicotine interventions ( e.g. counseling , bupropion ) are used , whereas the follicular menstrual phase appears favorable when nicotine interventions are used .
-BACKGROUND	Thus , there may be an interaction between menstrual phase and response to nicotine .
-BACKGROUND	We sought to examine the role of menstrual phase on response to nicotine during acute smoking abstinence .
-METHODS	In this controlled cross-over trial , women completed two identical experimental sessions ( follicular [ F ] vs. luteal [ L ] phase ) after four days of biochemically-verified smoking abstinence .
-METHODS	During the sessions , nicotine nasal spray was administered , and participants provided a series of subjective assessments .
-RESULTS	Participants ( n = 140 ) were 29.76.6 years old and smoked 12.65.8 cigarettes per day .
-RESULTS	Compared to the F phase , the L phase was associated with a greater increase in stimulation ( 7.22.2 vs. 14.42.3 , p = 0.01 , respectively ) and greater decrease in urge to smoke ( -13.62.3 vs. -21.12.5 , p = 0.02 , respectively ) after the first dose of nicotine .
-RESULTS	No other significant differences were observed .
-CONCLUSIONS	Out of 13 total measures examined at two different time points , we observed only two significant menstrual phase differences in the subjective response to nicotine .
-CONCLUSIONS	Therefore , these data do not provide strong evidence for a menstrual phase difference in the subjective response to nicotine .
-CONCLUSIONS	Additional research is needed to confirm this relationship and explore how non-nicotine smoking reinforcements ( such as sensory sensations ) may vary by menstrual phase .
-
-###24530023
-OBJECTIVE	To compare the outcomes of congenital cataract surgery using intraoperative intracameral triamcinolone versus postoperative oral prednisolone to modulate ocular inflammation .
-METHODS	Department of Congenital Cataract , Altino Ventura Foundation , Recife , Brazil .
-METHODS	Randomized clinical trial .
-METHODS	Children younger than 2 years were randomly divided into 2 groups .
-METHODS	The study group received an intraoperative intracameral injection of 1.2 mg/0 .03 mL of triamcinolone acetonide .
-METHODS	The control group ( 29 eyes ) received 1 mg/kg per day of prednisolone syrup for 15 days postoperatively , which was then tapered over the following 2 weeks .
-METHODS	Intraocular pressure ( IOP ) , central corneal thickness ( CCT ) , cell deposits on the intraocular lens ( IOL ) , posterior synechiae , visual axis obscuration , additional surgical procedures , and IOL centration were assessed 12 months postoperatively .
-RESULTS	The mean patient age at surgery was 10.45 months6 .22 ( SD ) in the study group ( 31 eyes ) and 10.06.15 months in the control group ( 29 eyes ) ( P = .779 ) .
-RESULTS	In both groups , the mean IOP and CCT did not change significantly postoperatively ( study group P = .922 and P = .149 , respectively ; control group P = .483 and P = .416 , respectively ) .
-RESULTS	The groups had similar incidences of cell deposits ( P = .517 ) and posterior synechiae ( P = .247 ) .
-RESULTS	No eye developed visual axis obscuration or had additional surgical procedures .
-RESULTS	All eyes had a clinically centered IOL .
-CONCLUSIONS	One year postoperatively , the outcomes were similar with intraoperative intracameral triamcinolone injection and postoperative oral prednisolone for modulating inflammation after congenital cataract surgery .
-BACKGROUND	No author has a financial or proprietary interest in any material or method mentioned .
-
-###24447238
-OBJECTIVE	To assess the effect of preventive pravastatin treatment on coronary heart disease ( CHD ) morbidity and mortality in older persons at risk for cardiovascular disease ( CVD ) , stratified according to plasma levels of homocysteine .
-METHODS	A post hoc subanalysis in the PROspective Study of Pravastatin in the Elderly at Risk ( PROSPER ) , started in 1997 , which is a double-blind , randomized , placebo-controlled trial with a mean follow-up of 3.2 years .
-METHODS	Primary care setting in two of the three PROSPER study sites ( Netherlands and Scotland ) .
-METHODS	Individuals ( n = 3,522 , aged 70-82 , 1,765 male ) with a history of or risk factors for CVD were ranked in three groups depending on baseline homocysteine level , sex , and study site .
-METHODS	Pravastatin ( 40 mg ) versus placebo .
-METHODS	Fatal and nonfatal CHD and mortality .
-RESULTS	In the placebo group , participants with a high homocysteine level ( n = 588 ) had a 1.8 higher risk ( 95 % confidence interval ( CI ) = 1.2-2 .5 , P = .001 ) of fatal and nonfatal CHD than those with a low homocysteine level ( n = 597 ) .
-RESULTS	The absolute risk reduction in fatal and nonfatal CHD with pravastatin treatment was 1.6 % ( 95 % CI = -1.6 to 4.7 % ) in the low homocysteine group and 6.7 % ( 95 % CI = 2.7-10 .7 % ) in the high homocysteine group ( difference 5.2 % , 95 % CI = 0.11-10 .3 , P = .046 ) .
-RESULTS	Therefore , the number needed to treat ( NNT ) with pravastatin for 3.2 years for benefit related to fatal and nonfatal CHD events was 14.8 ( 95 % CI = 9.3-36 .6 ) for high homocysteine and 64.5 ( 95 % CI = 21.4 - ) for low homocysteine .
-CONCLUSIONS	In older persons at risk of CVD , those with high homocysteine are at highest risk for fatal and nonfatal CHD .
-CONCLUSIONS	With pravastatin treatment , this group has the highest absolute risk reduction and the lowest NNT to prevent fatal and nonfatal CHD .
-
-###24589500
-BACKGROUND	Current parameters for assessing the efficacy of actinic keratosis ( AK ) treatments compare clinical lesions at the start and end of a study .
-BACKGROUND	However , the sun-exposed field also contains subclinical lesions which may become detectable during treatment .
-BACKGROUND	Lmax , the maximum lesion count during treatment , is a new concept to better assess the efficacy of field-directed AK therapies .
-BACKGROUND	Measuring efficacy using the reduction in lesions from Lmax includes for the first time the clearance of both subclinical and clinical lesions .
-OBJECTIVE	To evaluate the reduction of lesions from Lmax to study end and compare the results with traditional efficacy endpoints using imiquimod 3.75 % ( IQ3 .75 % ) as an example of field-directed AK therapy .
-METHODS	Pooled analysis of data from two 14-week , vehicle-controlled , double-blind studies of IQ3 .75 % .
-RESULTS	With IQ3 .75 % , the median number of lesions increased from 10 at baseline to an Lmax of 22 .
-RESULTS	The median absolute reduction in lesions to study end was 18 from Lmax versus 7 from baseline .
-RESULTS	The median percentage reduction in AK lesions to study end was 92.2 % from Lmax compared with 81.8 % from baseline .
-CONCLUSIONS	The reduction in lesion count from Lmax is a novel efficacy parameter that should become the new way of evaluating field-directed AK therapies since it enables their efficacy against both clinical and subclinical lesions to be accurately determined .
-CONCLUSIONS	Together , the Lmax concept and IQ3 .75 % represent a new approach for the management of AK across a large sun-exposed field .
-
-###24885593
-BACKGROUND	Individual work performance is an important outcome measure in studies in the workplace .
-BACKGROUND	Nevertheless , its conceptualization and measurement has proven challenging .
-BACKGROUND	To overcome limitations of existing scales , the Individual Work Performance Questionnaire ( IWPQ ) was recently developed .
-BACKGROUND	The aim of the current study was to gain insight into the responsiveness of the IWPQ .
-METHODS	Data were used from the Be Active & Relax randomized controlled trial .
-METHODS	The aim of the trial was to investigate the effectiveness of an intervention to stimulate physical activity and relaxation of office workers , on need for recovery .
-METHODS	Individual work performance was a secondary outcome measure of the trial .
-METHODS	In total , 39 hypotheses were formulated concerning correlations between changes on the IWPQ scales and changes on similar constructs ( e.g. , presenteeism ) and distinct constructs ( e.g. , need for recovery ) used in the trial .
-RESULTS	260 Participants completed the IWPQ at both baseline and 12 months of follow-up .
-RESULTS	For the IWPQ scales , 23 % , 15 % , and 38 % , respectively , of the hypotheses could be confirmed .
-RESULTS	In general , the correlations between change scores were weaker than expected .
-RESULTS	Nevertheless , at least 85 % of the correlations were in the expected direction .
-CONCLUSIONS	Based on results of the current study , no firm conclusions can be drawn about the responsiveness of the IWPQ .
-CONCLUSIONS	Several reasons may account for the weaker than expected correlations .
-CONCLUSIONS	Future research on the IWPQ 's responsiveness should be conducted , preferably in other populations and intervention studies , where greater changes over time can be expected .
-
-###24484268
-OBJECTIVE	To determine the efficacy of topical application of the autologous platelet gel ( PG ) in canine chronic protracted decubital ulcers .
-METHODS	Prospective , randomized , blind controlled clinical trial .
-METHODS	Dogs ( n = 18 ) with bilateral chronic wounds caused by protracted decubitus ulcers .
-METHODS	For each dog , wound side was randomized to receive either platelet gel ( group PG ) every 5 days for 5 dressing changes , or paraffin gauzes dressings ( group C ) , as negative control .
-METHODS	Wound healing and wound surfaces were compared at admission and then evaluated every 5th day , until day 25 .
-METHODS	Outcome variables were : open wound area , reduction of open wound surface compared to admission and to each preceding dressing change , time to complete epithelialization .
-RESULTS	Significant differences in healing process were observed at day 5 and continued throughout the entire study period ( P < .00001 ) .
-RESULTS	At 25 days , mean percent reduction in wound area was 93.5 % in group PG and 13.2 % in group C ( P < .00001 ) .
-CONCLUSIONS	Appropriately prepared autologous PG , an inexpensive , readily available blood derivative , applied topically results in more rapid healing of chronic non-healing decubital ulcers in dogs than those treated by use of paraffin-impregnated gauzes .
-
-###25268370
-BACKGROUND	The randomised phase III TURANDOT trial compared first-line bevacizumab-paclitaxel ( BEV-PAC ) vs bevacizumab-capecitabine ( BEV-CAP ) in HER2-negative locally recurrent/metastatic breast cancer ( LR/mBC ) .
-BACKGROUND	The interim analysis revealed no difference in overall survival ( OS ; primary end point ) between treatment arms ; however , progression-free survival ( PFS ) and objective response rate were significantly superior with BEV-PAC .
-BACKGROUND	We sought to identify patient populations that may be most appropriately treated with one or other regimen .
-METHODS	Patients with HER2-negative LR/mBC who had received no prior chemotherapy for advanced disease were randomised to either BEV-PAC ( bevacizumab 10 mg kg ( -1 ) days 1 and 15 plus paclitaxel 90 mg m ( -2 ) days 1 , 8 and 15 q4w ) or BEV-CAP ( bevacizumab 15 mg kg ( -1 ) day 1 plus capecitabine 1000 mg m ( -2 ) bid days 1-14 q3w ) .
-METHODS	The study population was categorised into three cohorts : triple-negative breast cancer ( TNBC ) , high-risk hormone receptor-positive ( HR + ) and low-risk HR + .
-METHODS	High - and low-risk HR + were defined , respectively , as having 2 vs 1 of the following four risk factors : disease-free interval 24 months ; visceral metastases ; prior ( neo ) adjuvant anthracycline and/or taxane ; and metastases in 3 organs .
-RESULTS	The treatment effect on OS differed between cohorts .
-RESULTS	Non-significant OS trends favoured BEV-PAC in the TNBC cohort and BEV-CAP in the low-risk HR + cohort .
-RESULTS	In all three cohorts , there was a non-significant PFS trend favouring BEV-PAC .
-RESULTS	Grade 3 adverse events were consistently less common with BEV-CAP .
-CONCLUSIONS	A simple risk factor index may help in selecting bevacizumab-containing regimens , balancing outcome , safety profile and patient preference .
-CONCLUSIONS	Final OS results are expected in 2015 ( ClinicalTrials.gov NCT00600340 ) .
-
-###25136638
-OBJECTIVE	The present study aims to explore the effects of vitamin E and omega-3 on endothelial function indicators among adolescents with metabolic syndrome .
-METHODS	In a randomized , double blind , and placebo-controlled trial , 90 young individuals , aged 10 to 18 years , with metabolic syndrome were randomly assigned to receive either vitamin E tablets ( 400IU/day ) or omega-3 tablets ( 2.4 gr/day ) or placebo .
-METHODS	For assessing endothelial functional state , the serum level of vascular endothelial growth factor ( VEGF ) was measured by ELISA test .
-RESULTS	The use of omega-3 supplementation for eight weeks led to significant increase in serum HDL level compared with the group treated with vitamin E or placebo group .
-RESULTS	In this regard , no significant correlations were found between the change in VEGF and baseline levels of other markers including anthropometric indices and serum lipids .
-RESULTS	Omega-3 could significantly reduce VEGF with the presence of other baseline variables ( Beta = -12.55 ; P = 0.012 ) .
-CONCLUSIONS	The administration of omega-3 can effectively improve endothelial function in adolescents with metabolic syndrome by reducing the level of serum VEGF , as a major index for atherosclerosis progression and endothelial destabilization .
-CONCLUSIONS	Omega-3 can be proposed as a VEGF antagonist for improving endothelial function in metabolic syndrome .
-CONCLUSIONS	The clinical implications of our findings should be assessed in future studies .
-
-###25744115
-OBJECTIVE	To evaluate the 5-year efficacy and safety of once weekly exenatide .
-METHODS	The Diabetes Therapy Utilization : Researching Changes in A1C , Weight and Other Factors Through Intervention with Exenatide Once Weekly ( DURATION-1 ) randomized clinical trial consisted of a 30-week controlled phase ( 2 mg of exenatide once weekly vs 10 g of exenatide twice daily ) with an open-ended uncontrolled extension ( once weekly exenatide only ) in patients with type 2 diabetes mellitus on background glucose-lowering therapies ( April 15 , 2006 , through February 21 , 2012 ) .
-METHODS	At week 30 , patients initially receiving 10 g of exenatide twice daily switched to 2 mg of exenatide once weekly .
-METHODS	Study end points included changes from baseline in hemoglobin A1c , fasting plasma glucose , weight , lipids , and blood pressure .
-METHODS	Long-term safety data included adverse events , liver and renal function , and heart rate .
-RESULTS	Of 258 extension-phase patients , 153 ( 59.3 % ) completed 5 years of treatment .
-RESULTS	Hemoglobin A1c levels were significantly and durably reduced from baseline ( least-squares mean , -1.6 % ; 95 % CI , -1.8 % to -1.4 % ; vs -1.9 % for exenatide once weekly at week 30 ) , and 65 ( 43.9 % ) of 148 patients achieved hemoglobin A1c levels of less than 7.0 % .
-RESULTS	Significant improvements in fasting plasma glucose level ( -28.8 mg/dL ; 95 % CI , -36.2 to -21.5 mg/dL ) , weight ( -3.0 kg ; 95 % CI , -4.6 to -1.3 kg ) , lipids , and diastolic blood pressure were observed , with minimal heart rate increase .
-RESULTS	Frequencies of nausea and injection-site reactions or nodules were decreased vs the initial 30-week controlled phase .
-RESULTS	Minor hypoglycemia occurred predominantly with sulfonylurea use , and no major hypoglycemia or new safety signals were observed .
-CONCLUSIONS	Long-term once weekly exenatide treatment was generally well tolerated with sustained glycemic improvement , weight reduction , and improved markers of cardiovascular risk in patients with type 2 diabetes .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00308139 .
-
-###24867469
-BACKGROUND	The use of single-port laparoscopy for left-lateral liver sectionectomy ( LLLS ) has been reported in the literature , but the effectiveness and safety of LLLS has not been validated in randomized , controlled trials .
-BACKGROUND	This prospective randomized controlled trial compared the effectiveness and safety of single-port and multi-port laparoscopic LLLS for the surgical treatment of benign liver disease .
-METHODS	Altogether , 38 patients aged 17-65 years ( 16 men , 22 women ) with benign liver diseases were hospitalized for elective laparoscopic LLLS between January 2010 and December 2012 .
-METHODS	Patients were randomly assigned to either single-port ( n = 19 ) or multi-port ( n = 19 ) laparoscopic LLLS .
-METHODS	Main outcome measures were operative time , volume of intraoperative blood loss , complication rates , and postoperative hospitalization .
-RESULTS	Baseline characteristics of the two groups were comparable .
-RESULTS	Single-port and multi-port laparoscopies were successfully completed in all but one patient ( 1/19 , 5.3 % ) who required conversion from a single-port to a multi-port procedure .
-RESULTS	The two groups had similar mean operative times and volumes of intraoperative blood loss .
-RESULTS	There were no clinically significant postoperative complications or deaths .
-RESULTS	The single-port group had a significantly shorter postoperative hospitalization than the multi-port group ( 2.5 1.7 vs. 4.0 2.1 days ; p < 0.05 ) .
-CONCLUSIONS	Single-port laparoscopic LLLS is a technically feasible , effective , safe alternative to multi-port laparoscopy for the treatment of benign liver diseases in cautiously selected patients .
-
-###25249056
-BACKGROUND	Behavioral interventions for obesity are commonly delivered in groups , although the effect of group size on weight loss has not been empirically evaluated .
-BACKGROUND	This behavioral weight loss trial compared the 6 - and 12-month weight changes associated with interventions delivered in a large group ( LG ) or small groups ( SG ) .
-METHODS	Obese adults ( N = 66 ; mean age = 50 years ; mean BMI = 36.5 kg/m2 ; 47 % African American ; 86 % women ) recruited from a health maintenance organization were randomly assigned to : ( 1 ) LG treatment ( 30 members/group ) , or ( 2 ) SG treatment ( 12 members/group ) .
-METHODS	Conditions were comparable in frequency and duration of treatment , which included 24 weekly group sessions ( months 1-6 ) followed by six monthly extended care contacts ( months 7-12 ) .
-METHODS	A mixed effects model with unstructured covariance matrix was applied to analyze the primary outcome of weight change while accounting for baseline weight and dependence among participants ' measurements over time .
-RESULTS	SG participants lost significantly more weight than LG participants at Month 6 ( -6.5 vs. -3.2 kg ; p = 0.03 ) and Month 12 ( -7.0 vs. -1.7 kg ; p < 0.002 ) .
-RESULTS	SG participants reported better treatment engagement and self-monitoring adherence at Months 6 and 12 , ps < 0.04 , with adherence fully mediating the relationship between group size and weight loss .
-CONCLUSIONS	Receiving obesity treatment in smaller groups may promote greater weight loss and weight loss maintenance .
-CONCLUSIONS	This effect may be due to improved adherence facilitated by SG interactions .
-CONCLUSIONS	These novel findings suggest that the perceived efficiency of delivering behavioral weight loss treatment to LGs should be balanced against the potentially better outcomes achieved by a SG approach .
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-###24354738
-OBJECTIVE	This research was conducted with the aim of determining the influence of three different oral care solutions on oral mucous membrane integrity in critically ill patients .
-BACKGROUND	Oral care is a basic part of nursing care in intensive care units .
-METHODS	A randomized controlled trial was conducted .
-METHODS	A total of 60 patients ( 20 patients in each group ) comprised the study sample of the research .
-METHODS	Patients were randomly allocated to three groups .
-METHODS	Patients in groups 1 , 2 and 3 were administered mouth care three times a day using 5 % sodium bicarbonate , 02 % chlorhexidine and saline solution , respectively .
-METHODS	Data were collected by means of a ` Descriptive characteristics form ' and an ` oral assessment tool ' .
-RESULTS	Mean scores of oral assessment tool increased according to days in all groups , however , this increase was found to be statistically insignificant ( p > 005 ) .
-RESULTS	Mean scores of the patients in saline solution group were seen to be lower than those of the other groups .
-RESULTS	When inter-group comparison of days was done , the difference between oral assessment scores was found to be statistically significant ( p = 0000 ) .
-CONCLUSIONS	It was found that there was no difference between patient groups receiving saline solution , sodium bicarbonate and 02 % chlorhexidine for mouth care in terms of oral mucous membrane integrity ; oral mucosa of all patients was found to be mildly dysfunctioning .
-CONCLUSIONS	It is thought that standardized protocols for oral hygiene developed in the light of the findings of randomized controlled trials may improve the oral health in critically ill patients .
-
-###25265976
-OBJECTIVE	Angina pectoris is common in patients with heart failure and reduced ejection fraction ( HF-REF ) but its relationship with outcomes has not been well defined .
-OBJECTIVE	This relationship was investigated further in a retrospective analysis of the Controlled Rosuvastatin Multinational Trial in Heart Failure ( CORONA ) .
-RESULTS	Four thousand , eight hundred and seventy-eight patients were divided into three categories : no history of angina and no chest pain at baseline ( Group A ; n = 1240 ) , past history of angina but no chest pain at baseline ( Group B ; n = 1353 ) and both a history of angina and chest pain at baseline ( Group C ; n = 2285 ) .
-RESULTS	Outcomes were examined using Kaplan-Meier and Cox regression survival analysis .
-RESULTS	Compared with Group A , Group C had a higher risk of non-fatal myocardial infarction or unstable angina ( HR : 2.36 , 1.54-3 .61 ; P < 0.001 ) , this composite plus coronary revascularization ( HR : 2.54 , 1.76-3 .68 ; P < 0.001 ) , as well as HF hospitalization ( HR : 1.35 , 1.13-1 .63 ; P = 0.001 ) , over a median follow-up period of 33 months .
-RESULTS	There was no difference in cardiovascular or all-cause mortality .
-RESULTS	Group B had a smaller increase in risk of coronary events but not of heart failure hospitalization .
-CONCLUSIONS	Patients with HF-REF and ongoing angina are at an increased risk of acute coronary syndrome and HF hospitalization .
-CONCLUSIONS	Whether these patients would benefit from more aggressive medical therapy or percutaneous revascularization is not known and merits further investigation .
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-###24528686
-BACKGROUND	Primary cardiovascular prevention may be achieved by lifestyle/nutrition improvements and specific drugs , although a relevant role is now emerging for specific functional foods and nutraceuticals .
-OBJECTIVE	The aim of this study was to evaluate the usefulness of a nutraceutical multitarget approach in subjects with moderate cardiovascular risk and to compare it with pravastatin treatment .
-METHODS	Thirty patients with moderate dyslipidemia and metabolic syndrome ( according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection , Evaluation , and Treatment of High Blood Cholesterol in Adults ) were included in an 8-week randomized , double-blind crossover study and took either placebo or a nutraceutical combination that contained red yeast rice extract , berberine , policosanol , astaxanthin , coenzyme Q10 , and folic acid ( Armolipid Plus ) .
-METHODS	Subsequently , they were subjected to another 8-week treatment with pravastatin 10 mg/d .
-METHODS	This dosage was selected on the basis of its expected -20 % efficacy in reducing low-density lipoprotein-cholesterol .
-RESULTS	Treatment with Armolipid Plus led to a significant reduction of total cholesterol ( -12.8 % ) and low-density lipoprotein-cholesterol ( -21.1 % ) , similar to pravastatin ( -16 % and -22.6 % , respectively ) , and an increase of high-density lipoprotein-cholesterol ( 4.8 % ) .
-RESULTS	Armolipid Plus improved the leptin-to-adiponectin ratio , whereas adiponectin levels were unchanged .
-CONCLUSIONS	These results indicate that this nutraceutical approach shows a lipid-lowering activity comparable to pravastatin treatment .
-CONCLUSIONS	Hence , it may be a safe and useful option , especially in conditions of moderate cardiovascular risk , in which a pharmacologic intervention may not be appropriate .
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-###25751701
-OBJECTIVE	Despite the prevalence and the functional , psychological , and economic impact of chronic pain , few intervention studies of treatment of chronic pain in veterans have been performed .
-OBJECTIVE	To determine whether a stepped-care intervention is more effective than usual care , as hypothesized , in reducing pain-related disability , pain interference , and pain severity .
-METHODS	We performed a randomized clinical trial comparing stepped care with usual care for chronic pain .
-METHODS	We enrolled 241 veterans from Operation Enduring Freedom , Operation Iraqi Freedom , and Operation New Dawn with chronic ( > 3 months ) and disabling ( Roland Morris Disability Scale score , 7 ) musculoskeletal pain of the cervical or lumbar spine or extremities ( shoulders , knees , and hips ) in the Evaluation of Stepped Care for Chronic Pain ( ESCAPE ) trial from December 20 , 2007 , through June 30 , 2011 .
-METHODS	The 9-month follow-up was completed by April 2012 .
-METHODS	Patients received treatment at a postdeployment clinic and 5 general medicine clinics at a Veterans Affairs medical center .
-METHODS	Step 1 included 12 weeks of analgesic treatment and optimization according to an algorithm coupled with pain self-management strategies ; step 2 , 12 weeks of cognitive behavioral therapy .
-METHODS	All intervention aspects were delivered by nurse care managers .
-METHODS	Pain-related disability ( Roland Morris Disability Scale ) , pain interference ( Brief Pain Inventory ) , and pain severity ( Graded Chronic Pain Scale ) .
-RESULTS	The primary analysis included 121 patients receiving the stepped-care intervention and 120 patients receiving usual care .
-RESULTS	At 9 months , the mean decrease from baseline in the Roland Morris Disability Scale score was 1.7 ( 95 % CI , -2.6 to -0.9 ) points in the usual care group and 3.7 ( 95 % CI , -4.5 to -2.8 ) points in the intervention group ( between-group difference , -1.9 [ 95 % CI , -3.2 to -0.7 ] points ; P = .002 ) .
-RESULTS	The mean decrease from baseline in the Pain Interference subscale score of the Brief Pain Inventory was 0.9 points in the usual care group and 1.7 points in the intervention group ( between-group difference , -0.8 [ 95 % CI , -1.3 to -0.3 ] points ; P = .003 ) .
-RESULTS	The Graded Chronic Pain Scale severity score was reduced by 4.5 points in the usual care group and 11.1 points in the intervention group ( between-group difference , -6.6 [ 95 % CI , -10.5 to -2.7 ] points ; P = .001 ) .
-CONCLUSIONS	A stepped-care intervention that combined analgesics , self-management strategies , and brief cognitive behavioral therapy resulted in statistically significant reductions in pain-related disability , pain interference , and pain severity in veterans with chronic musculoskeletal pain .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00386243 .
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-###24408120
-OBJECTIVE	Ferric citrate hydrate is a novel iron-based phosphate binder being developed for hyperphosphatemia in patients with CKD .
-METHODS	A phase 3 , multicenter , randomized , double blind , placebo-controlled study investigated the efficacy and safety of ferric citrate hydrate in nondialysis-dependent patients with CKD .
-METHODS	Starting in April of 2011 , 90 CKD patients ( eGFR = 9.215.72 ml/min per 1.73 m ( 2 ) ) with a serum phosphate5 .0 mg/dl were randomized 2:1 to ferric citrate hydrate or placebo for 12 weeks .
-METHODS	The primary end point was change in serum phosphate from baseline to the end of treatment .
-METHODS	Secondary end points included the percentage of patients achieving target serum phosphate levels ( 2.5-4 .5 mg/dl ) and change in fibroblast growth factor-23 at the end of treatment .
-RESULTS	The mean change in serum phosphate was -1.29 mg/dl ( 95 % confidence interval , -1.63 to -0.96 mg/dl ) in the ferric citrate hydrate group and 0.06 mg/dl ( 95 % confidence interval , -0.20 to 0.31 mg/dl ) in the placebo group ( P < 0.001 for difference between groups ) .
-RESULTS	The percentage of patients achieving target serum phosphate levels was 64.9 % in the ferric citrate hydrate group and 6.9 % in the placebo group ( P < 0.001 ) .
-RESULTS	Fibroblast growth factor-23 concentrations were significantly lower in patients treated with ferric citrate hydrate versus placebo ( change from baseline [ median ] , -142.0 versus 67.0 pg/ml ; P < 0.001 ) .
-RESULTS	Ferric citrate hydrate significantly increased serum iron , ferritin , and transferrin saturation compared with placebo ( P = 0.001 or P < 0.001 ) .
-RESULTS	Five patients discontinued active treatment because of treatment-emergent adverse events with ferric citrate hydrate treatment versus one patient with placebo .
-RESULTS	Overall , adverse drug reactions were similar in patients receiving ferric citrate hydrate or placebo , with gastrointestinal disorders occurring in 30.0 % of ferric citrate hydrate patients and 26.7 % of patients receiving placebo .
-CONCLUSIONS	In patients with nondialysis-dependent CKD , 12-week treatment with ferric citrate hydrate resulted in significant reductions in serum phosphate and fibroblast growth factor-23 while simultaneously increasing serum iron parameters .
-
-###25042693
-OBJECTIVE	Duchenne and Becker muscular dystrophies ( DBMD ) are allelic disorders caused by mutations in dystrophin .
-OBJECTIVE	Adults with DBMD develop life-threatening cardiomyopathy .
-OBJECTIVE	Inhibition of phosphodiesterase 5 ( PDE5 ) improves cardiac function in mouse models of DBMD .
-OBJECTIVE	To determine whether the PDE5-inhibitor sildenafil benefits human dystrophinopathy , we conducted a randomized , double-blind , placebo-controlled trial ( ClinicalTrials.gov , number NCT01168908 ) .
-METHODS	Adults with DBMD and cardiomyopathy ( ejection fraction50 % ) were randomized to receive sildenafil ( 20mg 3 daily ) or placebo for 6 months .
-METHODS	All subjects received an additional 6 months of open-label sildenafil .
-METHODS	The primary endpoint was change in left ventricular end-systolic volume ( LVESV ) on cardiac magnetic resonance imaging .
-METHODS	Secondary cardiac endpoints , skeletal muscle function , and quality of life were also assessed .
-RESULTS	An interim analysis ( performed after 15 subjects completed the blinded phase ) revealed that 29 % ( 4 of 14 ) of subjects had a 10 % increase in LVESV after 6 months of sildenafil compared to 13 % ( 1 of 8 ) of subjects receiving placebo .
-RESULTS	Subjects with LVESV > 120ml at baseline were more likely to worsen at 12 months regardless of treatment assignment ( p = 0.035 ) .
-RESULTS	Due to the higher number of subjects worsening on sildenafil , the data and safety monitoring board recommended early termination of the study .
-RESULTS	There were no statistically significant differences in outcome measures between treatment arms .
-CONCLUSIONS	Due to the small sample size , comparisons between groups must be interpreted with caution .
-CONCLUSIONS	However , this trial suggests that sildenafil is unlikely to improve cardiac function in adults with DBMD .
-
-###25639732
-OBJECTIVE	The aim of the present exploratory clinical study was to evaluate LD as an add-on therapy for treating nightmares .
-METHODS	Thirty-two subjects having nightmares ( ICD-10 : F51 .5 ) at least twice a week participated .
-METHODS	Subjects were randomly assigned to group : A ) Gestalt therapy group ( = GTG ) , or B ) Gestalt and lucid dreaming group therapy ( = LDG ) .
-METHODS	Each group lasted ten weeks .
-METHODS	Participants kept a sleep/dream diary over the treatment .
-METHODS	Examinations with respect to nightmare frequency and sleep quality ( Pittsburgh Sleep Quality Index ) were carried out at the beginning , after five and ten weeks and at a follow-up three months later .
-RESULTS	Concerning nightmare frequency , a significant reduction was found in both groups after the ten-week-study and at the follow-up ( Wilcoxon test : P 0.05 ) .
-RESULTS	Significant reduction in dream recall frequency could only be observed in the GTG ( Wilcoxon test : P 0.05 ) .
-RESULTS	For subjects having succeeded in learning lucid dreaming , reduction was sooner and higher .
-RESULTS	Sleep quality improved for both groups at the follow-up ( P 0.05 , Wilcoxon test ) .
-RESULTS	Only the LDG showed significant improvement at the end of therapy ( P 0.05 ) .
-CONCLUSIONS	Lucid dreaming , in combination with Gestalt therapy , is a potent technique to reduce nightmare frequency and improve the subjective quality of sleep .
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-###25033590
-BACKGROUND	In Serbia , there have been no broad campaigns or educational programs focused on adolescents ' sun protection .
-OBJECTIVE	The aim of the study was to assess whether an educational program would have impact on changes of attitudes and sun-protective behaviors of high school students .
-OBJECTIVE	More specific aim was to examine whether sex and age differences in sun behavior exists .
-METHODS	Educational program was designed to provoke changes in attitudes towards sun protection and sun behavior .
-METHODS	The investigation was carried out in Belgrade , Serbia in two educational cycles , during spring 2007 and 2008 .
-METHODS	Sixteen - and 17-year old high schools students were targeted and assessed before and after the educational intervention by means of self-report questionnaire designed for this study ( about skin types and sun behavior ) .
-METHODS	The students ' attitudes towards sun protection and sun behavior before and after the educational intervention were compared and analyzed by the Pearson 's chi-square test and logistic regression analyses .
-METHODS	In the second educational cycle ( 2008 ) age and gender differences in sun behavior were analyzed .
-RESULTS	Overall 3205 students in 2007 , and 2155 students in 2008 year from 11 high schools participated .
-RESULTS	A statistically significant behavior change was observed for the use of sunglasses in 2007 -- the number of students using them increased from 41.6 % to 45.6 % ( p < 0.05 ) .
-RESULTS	There were no significant changes in other ways of protection i.e. sunscreen use , protective clothes or staying in shade .
-CONCLUSIONS	Educational program had an impact , but broader activities involving schools , local communities and media are needed for significant changes in sun behavior and attitude .
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-###25668262
-OBJECTIVE	There are no treatments available to slow or prevent the progression of Parkinson disease , despite its global prevalence and significant health care burden .
-OBJECTIVE	The National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson Disease program was established to promote discovery of potential therapies .
-OBJECTIVE	To determine whether creatine monohydrate was more effective than placebo in slowing long-term clinical decline in participants with Parkinson disease .
-METHODS	The Long-term Study 1 , a multicenter , double-blind , parallel-group , placebo-controlled , 1:1 randomized efficacy trial .
-METHODS	Participants were recruited from 45 investigative sites in the United States and Canada and included 1741 men and women with early ( within 5 years of diagnosis ) and treated ( receiving dopaminergic therapy ) Parkinson disease .
-METHODS	Participants were enrolled from March 2007 to May 2010 and followed up until September 2013 .
-METHODS	Participants were randomized to placebo or creatine ( 10 g/d ) monohydrate for a minimum of 5 years ( maximum follow-up , 8 years ) .
-METHODS	The primary outcome measure was a difference in clinical decline from baseline to 5-year follow-up , compared between the 2 treatment groups using a global statistical test .
-METHODS	Clinical status was defined by 5 outcome measures : Modified Rankin Scale , Symbol Digit Modalities Test , PDQ-39 Summary Index , Schwab and England Activities of Daily Living scale , and ambulatory capacity .
-METHODS	All outcomes were coded such that higher scores indicated worse outcomes and were analyzed by a global statistical test .
-METHODS	Higher summed ranks ( range , 5-4775 ) indicate worse outcomes .
-RESULTS	The trial was terminated early for futility based on results of a planned interim analysis of participants enrolled at least 5 years prior to the date of the analysis ( n = 955 ) .
-RESULTS	The median follow-up time was 4 years .
-RESULTS	Of the 955 participants , the mean of the summed ranks for placebo was 2360 ( 95 % CI , 2249-2470 ) and for creatine was 2414 ( 95 % CI , 2304-2524 ) .
-RESULTS	The global statistical test yielded t1865 .8 = -0.75 ( 2-sided P = .45 ) .
-RESULTS	There were no detectable differences ( P < .01 to partially adjust for multiple comparisons ) in adverse and serious adverse events by body system .
-CONCLUSIONS	Among patients with early and treated Parkinson disease , treatment with creatine monohydrate for at least 5 years , compared with placebo did not improve clinical outcomes .
-CONCLUSIONS	These findings do not support the use of creatine monohydrate in patients with Parkinson disease .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00449865 .
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-###25085225
-BACKGROUND	There is a dual need for ( 1 ) innovative theory-based smartphone applications for smoking cessation and ( 2 ) controlled trials to evaluate their efficacy .
-BACKGROUND	Accordingly , this study tested the feasibility , acceptability , preliminary efficacy , and mechanism of behavioral change of an innovative smartphone-delivered acceptance and commitment therapy ( ACT ) application for smoking cessation vs. an application following US Clinical Practice Guidelines .
-METHODS	Adult participants were recruited nationally into the double-blind randomized controlled pilot trial ( n = 196 ) that compared smartphone-delivered ACT for smoking cessation application ( SmartQuit ) with the National Cancer Institute 's application for smoking cessation ( QuitGuide ) .
-RESULTS	We recruited 196 participants in two months .
-RESULTS	SmartQuit participants opened their application an average of 37.2 times , as compared to 15.2 times for QuitGuide participants ( p < 0001 ) .
-RESULTS	The overall quit rates were 13 % in SmartQuit vs. 8 % in QuitGuide ( OR = 2.7 ; 95 % CI = 0.8-10 .3 ) .
-RESULTS	Consistent with ACT 's theory of change , among those scoring low ( below the median ) on acceptance of cravings at baseline ( n = 88 ) , the quit rates were 15 % in SmartQuit vs. 8 % in QuitGuide ( OR = 2.9 ; 95 % CI = 0.6-20 .7 ) .
-CONCLUSIONS	ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines .
-CONCLUSIONS	As results were limited by the pilot design ( e.g. , small sample ) , a full-scale efficacy trial is now needed .
-
-###24678999
-BACKGROUND	The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy ( MADIT-CRT ) showed that early intervention with cardiac-resynchronization therapy with a defibrillator ( CRT-D ) in patients with an electrocardiographic pattern showing left bundle-branch block was associated with a significant reduction in heart-failure events over a median follow-up of 2.4 years , as compared with defibrillator therapy alone .
-METHODS	We evaluated the effect of CRT-D on long-term survival in the MADIT-CRT population .
-METHODS	Post-trial follow-up over a median period of 5.6 years was assessed among all 1691 surviving patients ( phase 1 ) and subsequently among 854 patients who were enrolled in post-trial registries ( phase 2 ) .
-METHODS	All reported analyses were performed on an intention-to-treat basis .
-RESULTS	At 7 years of follow-up after initial enrollment , the cumulative rate of death from any cause among patients with left bundle-branch block was 18 % among patients randomly assigned to CRT-D , as compared with 29 % among those randomly assigned to defibrillator therapy alone ( adjusted hazard ratio in the CRT-D group , 0.59 ; 95 % confidence interval [ CI ] , 0.43 to 0.80 ; P < 0.001 ) .
-RESULTS	The long-term survival benefit of CRT-D in patients with left bundle-branch block did not differ significantly according to sex , cause of cardiomyopathy , or QRS duration .
-RESULTS	In contrast , CRT-D was not associated with any clinical benefit and possibly with harm in patients without left bundle-branch block ( adjusted hazard ratio for death from any cause , 1.57 ; 95 % CI , 1.03 to 2.39 ; P = 0.04 ; P < 0.001 for interaction of treatment with QRS morphologic findings ) .
-CONCLUSIONS	Our findings indicate that in patients with mild heart-failure symptoms , left ventricular dysfunction , and left bundle-branch block , early intervention with CRT-D was associated with a significant long-term survival benefit .
-CONCLUSIONS	( Funded by Boston Scientific ; ClinicalTrials.gov numbers , NCT00180271 , NCT01294449 , and NCT02060110 . )
-
-###24448262
-OBJECTIVE	Mass drug administration ( MDA ) is part of the SAFE strategy for trachoma elimination .
-OBJECTIVE	This study examined the effect of three annual MDAs on prevalence of trachoma among 13 longitudinal cohorts of Tanzanian children .
-METHODS	Children younger than 10 years were assigned to cohorts based on age at baseline and followed annually for 3 years , with newborns assigned to new cohorts over time .
-METHODS	Annual MDA consisted of topical tetracycline for children younger than 6 months and oral azithromycin for those 6 months and older .
-METHODS	Follicular trachoma ( TF ) and Chlamydia trachomatis infection status were assessed annually before the next MDA .
-METHODS	Prevalence and risk factors for TF and infection at each age were compared across cohorts .
-RESULTS	At each survey , most age groups and cohorts had MDA coverage of more than 80 % and showed decreased TF prevalence after every MDA .
-RESULTS	One cohort had consistently lower coverage , higher-than-expected TF and infection at ages 6 and 7 , and elevated risk of TF at age 7 relative to the preceding cohort in spite of receiving one additional MDA ( odds ratio 2.3 , 95 % confidence interval 1.0-5 .2 ) .
-RESULTS	Cohorts aged 1 or older at baseline generally showed reductions in TF and infection after each MDA , whereas younger cohorts showed decreased infection but increased TF over time .
-RESULTS	Successive cohorts of never-treated children younger than 1 year showed sequential TF and infection reductions with each MDA ( P < 0.001 ) .
-CONCLUSIONS	Multiple MDAs significantly reduce trachoma prevalence and appear to increasingly protect children born into these communities .
-CONCLUSIONS	The youngest children show declining/stable rates of infection but increasing rates of trachoma , which may reflect longer duration of clinical signs .
-
-###24740662
-BACKGROUND	Tamoxifen , a synthetic nonsteroidal anti-estrogen known to modulate the production of transforming growth factor-beta ( TGF - ) , has demonstrated effectiveness on fibroblast activity in vitro and in vivo .
-BACKGROUND	The main purpose of this study was to investigate the effect of tamoxifen on the outcome of surgery for Dupuytren contractures in patients with a strong predisposition toward fibrosis .
-METHODS	We used a prospective , randomized , double-blind study protocol ( conforming to the CONSORT standards ) to investigate the influence of tamoxifen compared with placebo on the total passive extension deficit in the finger and patient satisfaction after subtotal fasciectomy in thirty patients with a strong predisposition toward fibrosis ( grade , > 4 according to the Abe scale ) .
-METHODS	High-dosage tamoxifen ( 80 mg/day ) was administered from six weeks prior until twelve weeks after surgery , and patients were monitored for two years .
-RESULTS	Three months after surgery , patients in the tamoxifen group had a smaller total passive extension deficit and higher satisfaction compared with the placebo group .
-RESULTS	This positive effect was lost over the two years following cessation of the medication .
-CONCLUSIONS	This study demonstrated that the short-term outcome of Dupuytren disease treatment could be influenced by use of tamoxifen as a neoadjuvant from six weeks prior to three months after subtotal fasciectomy in patients with a strong predisposition toward fibrosis .
-CONCLUSIONS	However , the beneficial effect disappeared within two years after surgery , with worsening of the contractures after the medication was discontinued .
-CONCLUSIONS	Thus , tamoxifen may have a short-term effect on the outcome of surgery for Dupuytren disease .
-
-###26460660
-BACKGROUND	Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality .
-BACKGROUND	Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass .
-BACKGROUND	We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass .
-METHODS	The Steroids In caRdiac Surgery ( SIRS ) study is a double-blind , randomised , controlled trial .
-METHODS	We used a central computerised phone or interactive web system to randomly assign ( 1:1 ) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone ( 250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass ) or placebo .
-METHODS	Patients were assigned with block randomisation with random block sizes of 2 , 4 , or 6 and stratified by centre .
-METHODS	Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6 .
-METHODS	Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days .
-METHODS	Patients , caregivers , and those assessing outcomes were masked to allocation .
-METHODS	The primary outcomes were 30-day mortality and a composite of death and major morbidity ( ie , myocardial injury , stroke , renal failure , or respiratory failure ) within 30 days , both analysed by intention to treat .
-METHODS	Safety outcomes were also analysed by intention to treat .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT00427388 .
-RESULTS	Patients were recruited between June 21 , 2007 , and Dec 19 , 2013 .
-RESULTS	Complete 30-day data was available for all 7507 patients randomly assigned to methylprednisolone ( n = 3755 ) and to placebo ( n = 3752 ) .
-RESULTS	Methylprednisolone , compared with placebo , did not reduce the risk of death at 30 days ( 154 [ 4 % ] vs 177 [ 5 % ] patients ; relative risk [ RR ] 087 , 95 % CI 070-107 , p = 019 ) or the risk of death or major morbidity ( 909 [ 24 % ] vs 885 [ 24 % ] ; RR 103 , 95 % CI 095-111 , p = 052 ) .
-RESULTS	The most common safety outcomes in the methylprednisolone and placebo group were infection ( 465 [ 12 % ] vs 493 [ 13 % ] ) , surgical site infection ( 151 [ 4 % ] vs 151 [ 4 % ] ) , and delirium ( 295 [ 8 % ] vs 289 [ 8 % ] ) .
-CONCLUSIONS	Methylprednisolone did not have a significant effect on mortality or major morbidity after cardiac surgery with cardiopulmonary bypass .
-CONCLUSIONS	The SIRS trial does not support the routine use of methylprednisolone for patients undergoing cardiopulmonary bypass .
-BACKGROUND	Canadian Institutes of Health Research .
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-###25447444
-BACKGROUND	Previous studies have reported the cardioprotective effect of dexmedetomidine and lidocaine .
-BACKGROUND	We compared the effect of lidocaine and dexmedetomidine infusion during off-pump coronary artery bypass graft ( OPCAB ) .
-METHODS	153 patients undergoing OPCAB were enrolled .
-METHODS	The lidocaine group ( n = 36 , Group LIDO ) received an infusion of lidocaine 2 mg/kg/h after bolus 1.5 mg/kg ; the dexmedetomidine group ( n = 40 , Group DEX ) received dexmedetomidine 0.3-0 .7 g/kg/h ; the combined group ( n = 39 , Group Combined ) received infusion of both drugs ; and the control group ( n = 38 ) received nothing .
-METHODS	We measured serum creatinine kinase-myocardial band ( CK-MB ) and cardiac troponin I ( cTnI ) concentration before and immediately after the surgery , postoperative day ( POD ) # 1 and # 2 .
-METHODS	The complication rate and clinical outcomes were compared .
-RESULTS	The concentration of cTnI was significantly lower in the Group LIDO and Group Combined than the control group on POD # 2 .
-RESULTS	The concentration of CK-MB was significantly lower in the Group LIDO and Group Combined compared to the control group on POD # 1 and # 2 [ CK-MB on POD # 1 : 7.67 ( 5.78-11 .92 ) vs. 7.18 ( 5.01-11 .72 ) vs. 13.19 ( 6.85-23 .87 ) in the Group LIDO , combined and control , respectively , Group LIDO vs. control : p = 0.003 , Group Combined vs. control : p = 0.015 ] .
-RESULTS	The AUC of CK-MB was significantly lower in the Group LIDO and Group Combined than the control group .
-RESULTS	However , clinical variables including complication rate , ICU stay and one-year mortality were not different .
-CONCLUSIONS	Lidocaine infused at 2 mg/kg/h , but not dexmedetomidine infused at 0.3-0 .7 g/kg/h reduced postoperative myocardial injury marker levels compared with the control group .
-CONCLUSIONS	However , no other clinical benefits were observed .
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-###25326135
-OBJECTIVE	To compare estimates by bioimpedance spectroscopy analysis ( BIS ) of extracellular water ( ECW ) , fat mass ( FM ) , and fat-free mass ( FFM ) against standard techniques of bromide dilution and dual energy X-ray absorptiometry ( DXA ) during intervention that causes significant changes in water compartments and body composition .
-METHODS	Body composition analysis using BIS , bromide dilution , and DXA was performed in 71 healthy recreational athletes ( 43 men , 28 women ; aged 18-40 years ; BMI 24 0.4 kg/m ( 2 ) ) who participated in a double-blinded , randomized , placebo-controlled study of GH and testosterone treatment .
-METHODS	The comparison of BIS with bromide dilution and DXA was analyzed using linear regression and the Bland-Altman method .
-RESULTS	At baseline , there was a significant correlation between BIS and bromide dilution-derived estimates for ECW , and DXA for FM and FFM ( P < 0.001 ) .
-RESULTS	ECW by BIS was 3.5 8.1 % lower compared with bromide dilution , while FM was 22.4 26.8 % lower and FFM 13.7 7.5 % higher compared with DXA ( P < 0.01 ) .
-RESULTS	During treatment , the change in ECW was similar between BIS and bromide dilution , whereas BIS gave a significantly greater reduction in FM ( 19.4 44.8 % ) and a greater increase in FFM ( 5.6 3.0 % ) compared with DXA ( P < 0.01 ) .
-RESULTS	Significant differences in body composition estimates between the BIS and DXA were observed only in men , particularly during the treatment that caused greatest change in water compartments and body composition .
-CONCLUSIONS	In healthy adults , bioimpedance spectroscopy is an acceptable tool for measuring ECW ; however , BIS overestimates FFM and substantially underestimates FM compared with DXA .
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-###24846035
-OBJECTIVE	Long-acting injectable antipsychotics are used to reduce medication nonadherence and relapse in schizophrenia-spectrum disorders .
-OBJECTIVE	The relative effectiveness of long-acting injectable versions of second-generation and older antipsychotics has not been assessed .
-OBJECTIVE	To compare the effectiveness of the second-generation long-acting injectable antipsychotic paliperidone palmitate with the older long-acting injectable antipsychotic haloperidol decanoate .
-METHODS	Multisite , double-blind , randomized clinical trial conducted from March 2011 to July 2013 at 22 US clinical research sites .
-METHODS	Randomized patients ( n = 311 ) were adults diagnosed with schizophrenia or schizoaffective disorder who were clinically assessed to be at risk of relapse and likely to benefit from a long-acting injectable antipsychotic .
-METHODS	Intramuscular injections of haloperidol decanoate 25 to 200 mg or paliperidone palmitate 39 to 234 mg every month for as long as 24 months .
-METHODS	Efficacy failure , defined as a psychiatric hospitalization , a need for crisis stabilization , a substantial increase in frequency of outpatient visits , a clinician 's decision that oral antipsychotic could not be discontinued within 8 weeks after starting the long-acting injectable antipsychotics , or a clinician 's decision to discontinue the assigned long-acting injectable due to inadequate therapeutic benefit .
-METHODS	Key secondary outcomes were common adverse effects of antipsychotic medications .
-RESULTS	There was no statistically significant difference in the rate of efficacy failure for paliperidone palmitate compared with haloperidol decanoate ( adjusted hazard ratio , 0.98 ; 95 % CI , 0.65-1 .47 ) .
-RESULTS	The number of participants who experienced efficacy failure was 49 ( 33.8 % ) in the paliperidone palmitate group and 47 ( 32.4 % ) in the haloperidol decanoate group .
-RESULTS	On average , participants in the paliperidone palmitate group gained weight and those in the haloperidol decanoate group lost weight ; after 6 months , the least-squares mean weight change for those taking paliperidone palmitate was increased by 2.17 kg ( 95 % CI , 1.25-3 .09 ) and was decreased for those taking haloperidol decanoate ( -0.96 kg ; 95 % CI , -1.88 to -0.04 ) .
-RESULTS	Patients taking paliperidone palmitate had significantly higher maximum mean levels of serum prolactin ( men , 34.56 g/L [ 95 % CI , 29.75-39 .37 ] vs 15.41 g/L [ 95 % CI , 10.73-20 .08 ] ; P < .001 , and for women , 75.19 [ 95 % CI , 63.03-87 .36 ] vs 26.84 [ 95 % CI , 13.29-40 .40 ] ; P < .001 ) .
-RESULTS	Patients taking haloperidol decanoate had significantly larger increases in global ratings of akathisia ( 0.73 [ 95 % CI , 0.59-0 .87 ] vs 0.45 [ 95 % CI , 0.31-0 .59 ] ; P = .006 ) .
-CONCLUSIONS	In adults with schizophrenia or schizoaffective disorder , use of paliperidone palmitate vs haloperidol decanoate did not result in a statistically significant difference in efficacy failure , but was associated with more weight gain and greater increases in serum prolactin , whereas haloperidol decanoate was associated with more akathisia .
-CONCLUSIONS	However , the CIs do not rule out the possibility of a clinically meaningful advantage with paliperidone palmitate .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01136772 .
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-###24451613
-OBJECTIVE	To investigate whether short-term systemic effects of wood smoke occurred in atopic subjects after experimental wood smoke exposures .
-METHODS	A double-blind climate chamber study was conducted on 20 healthy atopic subjects with exposures to filtered air and wood smoke .
-METHODS	Pneumoproteins , coagulation and adhesion factors , and cytokines were measured .
-METHODS	Heart rate was monitored with pulse monitors .
-METHODS	Data were analyzed with mixed models .
-RESULTS	Few differences in the outcomes were observed .
-RESULTS	Plasma tissue factor remained elevated during filtered air exposure ( P = 0.002 ) .
-RESULTS	P-selectin declined independent of exposure ( P = 0.0006 ) .
-RESULTS	Interleukin-6 increased after filtered air ( P = 0.03 ) .
-CONCLUSIONS	The study confirmed previous observations among nonatopics of limited changes after a 3-hour wood smoke exposure .
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-###24711149
-OBJECTIVE	It has been suggested that weight reduction decreases the frequency of urinary incontinence ( UI ) episodes .
-OBJECTIVE	However , it is not known if this improvement is associated with anatomical changes in the pelvis .
-OBJECTIVE	The aim of this study was to investigate the effects of weight loss on UI episodes and pelvic floor anatomy .
-METHODS	Three hundred seventy-eight overweight/obese women were randomly allocated either to behavioral weight loss or to structured education programs .
-METHODS	The patients were evaluated by voiding diary , Pelvic Floor Distress Inventory ( PFDI ) , and Pelvic Organ Prolapse Quantification ( POP-Q ) system at baseline and after 6months .
-RESULTS	The women in the intervention group had a mean weight loss of 9.4 % , whereas the weight in the control group remained almost the same ( P < 0.001 ) .
-RESULTS	While there were no change in stress and urge incontinence episodes in the control group , the mean number of stress incontinence episodes per 3-day diary dropped from 7.96 episodes to 3.11 , and the mean number of urge incontinence episodes per 3-day diary dropped from 2.85 episodes to 1.08 in the study group ( P < 0.05 ) .
-RESULTS	Regarding the POP-Q system , only genital hiatus , perineal body , and Ap measurements were significantly lower in the weight loss group than in the control group after 6months .
-CONCLUSIONS	Weight reduction provides improvement in episodes of UI , decreases the incidence of drops of urine leakage , and increases quality of life related to pelvic floor symptoms .
-CONCLUSIONS	However , there are little to no changes in the parameters of the POP-Q system with weight reduction .
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-###25007361
-BACKGROUND	Single-day , high-dose systemic antiviral drugs are effective in the treatment of labial herpes ( herpes labialis [ HL ] ) .
-BACKGROUND	Aciclovir Lauriad mucoadhesive buccal tablet ( ABT ) is an innovative drug delivery system providing high and prolonged exposure to aciclovir in the oral cavity , supporting its evaluation as a single low dose in HL .
-METHODS	In this multicenter double-blind placebo-controlled patient-initiated trial , 775 patients with recurrent HL were randomly assigned to either a single application of ABT 50 mg or a matching placebo as soon as prodromal symptoms occurred .
-METHODS	The primary endpoint was the time to healing ( TTH ) of primary vesicular lesion ( modified intention-to-treat population ) .
-METHODS	Other endpoints included incidence of blocked episodes , duration of herpes episodes , and incidence and time to next recurrence evaluated during a 9-month follow-up period ( intention-to-treat population ) .
-RESULTS	With ABT 50 mg , median TTH of primary vesicular lesion was reduced ( 7 days vs 7.3 days , P = .015 ) , the incidence of blocked herpes episodes was increased by 24.2 % ( 34.9 % vs 28.1 % ; P = .042 ) , and the median duration of herpes episodes was reduced ( 5.6 days vs 6.4 days , P = .003 ) .
-RESULTS	During the 9-month follow-up period , recurrence of herpes lesions was less frequent ( 64.2 % vs 73.6 % ; P = .027 ) and delayed ( 205 days vs 165 days , P = .041 ) in the ABT 50 mg .
-RESULTS	Both treatments were safe .
-CONCLUSIONS	A single application of ABT improves all endpoints of HL and might modify its clinical course in decreasing the incidence and delaying the onset of the next recurrence .
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-###25440797
-BACKGROUND	There is a need to evaluate and implement cost-effective strategies to improve adherence to treatments in coronary heart disease .
-BACKGROUND	There are no studies from low - to middle income countries ( LMICs ) evaluating trained community health worker ( CHW ) - based interventions for the secondary prevention of coronary heart disease .
-METHODS	We designed a hospital-based , open randomized trial of CHW-based interventions versus standard care .
-METHODS	Patients after an acute coronary syndrome ( ACS ) were randomized to an intervention group ( a CHW-based intervention package , comprising education tools to enhance self-care and adherence , and regular follow-up by the CHW ) or to standard care for 12 months during which study outcomes were recorded .
-METHODS	The CHWs were trained over a period of 6 months .
-METHODS	The primary outcome measure was medication adherence .
-METHODS	The secondary outcomes were differences in adherence to lifestyle modification , physiological parameters ( blood pressure [ BP ] , body weight , body mass index [ BMI ] , heart rate , lipids ) , and major adverse cardiovascular events .
-RESULTS	We recruited 806 patients stabilized after an ACS from 14 hospitals in 13 Indian cities .
-RESULTS	The mean age was 56.4 ( 11.32 ) years , and 17.2 % were females .
-RESULTS	A high prevalence of risk factors such as hypertension ( 43.4 % ) , diabetes ( 31.9 % ) , tobacco consumption ( 35.4 % ) , and inadequate physical activity ( 70.5 % ) was documented .
-RESULTS	A little over half had ST-elevation myocardial infarction ( 53.7 % ) , and 46.3 % had non-ST-elevation myocardial infarction or unstable angina .
-CONCLUSIONS	The CHW interventions and training for SPREAD have been developed and adapted for local use .
-CONCLUSIONS	The results and experience of this study will be important to counter the burden of cardiovascular diseases in low - to middle income countries .
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-###24828020
-OBJECTIVE	We assessed safety and efficacy of two selective 11-HSD1 inhibitors ( RO5093151/RO -151 and RO5027383/RO -838 ) in this randomized , controlled study in metformin-treated patients with type 2 diabetes .
-METHODS	Patients either received placebo ( N = 21 ) , RO-151 BID 5 mg ( N = 24 ) or 200 mg ( N = 20 ) or RO-838 QD 50 mg ( N = 21 ) or 200 mg ( N = 24 ) for 28 days .
-METHODS	Metabolic assessments comprising of nine-point plasma glucose profiles , oral glucose tolerance tests and determination of metabolic biomarkers including insulin , C-peptide , glucagon , HbA1c and lipids were done at baseline and end of treatment .
-RESULTS	Despite the short treatment duration , both RO-151 and RO-838 showed trends for improved HbA1c and consistent reductions in body weight ( -0.86 to -1.67 kg ) exceeding those observed with placebo ( -0.28 kg , p = 0.019 for 200 mg RO-151 vs. placebo ) .
-RESULTS	Insulin sensitivity parameters ( e.g. HOMA-IR and Matsuda-Index ) improved non-significantly with 200 mg RO-151 .
-RESULTS	Lipid parameters did not consistently improve with either compound , but RO-838 led to non-significant increases in triglycerides and VLDL-cholesterol versus placebo .
-RESULTS	Both compounds were well tolerated and showed inhibitory effects on 11-HSD1 activity based on urinary corticosteroid excretion .
-RESULTS	As reported for other 11-HSD1-inhibitors increased concentrations of ACTH and adrenal androgen precursors were found with RO-151 , but not with RO-838 .
-CONCLUSIONS	Slight metabolic improvements were seen , in particular with RO-151 high dose , however , the observed changes often did not reach statistical significance and were not clearly dose dependent .
-CONCLUSIONS	Studies of longer duration are needed to further investigate potential benefits and risks of these compounds .
-
-###25264109
-OBJECTIVE	To evaluate the effect of wearing a dorsiflexion assist orthosis ( DAO ) on walking distance , physiological cost , fatigue , and strength and balance measures after a modified 6-minute walk test ( 6MWT ) in people with multiple sclerosis ( MS ) .
-METHODS	Randomized crossover trial .
-METHODS	Hospital Movement Laboratory .
-METHODS	People with moderate MS and Expanded Disability Status Scale score of 3.70.7 ( N = 34 ; 26 women ) .
-METHODS	Modified 6MWT with and without a DAO worn on the weaker leg .
-METHODS	Distance walked , perceived fatigue , and the physiological cost of walking were compared between walking conditions .
-METHODS	Pre - and postwalk changes in knee extensor and ankle dorsiflexor isometric strength and standing postural sway with eyes open and closed were compared between walking conditions .
-RESULTS	There were no differences in distance walked or perceived fatigue between the 2 walking conditions .
-RESULTS	However , there was a reduced physiological cost of walking ( P < .05 ) , a smaller reduction in knee extensor strength ( P < .05 ) , and a smaller increase in standing postural sway with eyes open ( P < .01 ) after walking while wearing the DAO compared with walking without wearing the DAO .
-CONCLUSIONS	Despite not increasing walking distance or reducing perceived fatigue , the DAO reduced the physiological cost of walking and maintained knee strength and standing balance , which may have important implications for physical rehabilitation in people with MS. Further trials are required to determine whether the beneficial effects of wearing a DAO found here are maintained for longer periods .
-
-###25624379
-OBJECTIVE	Menu labels displaying food energy in physical activity calorie equivalents ( PACE ) is a possible strategy to encourage ordering meals with fewer calories and promoting physical activity .
-OBJECTIVE	Potential effects of such labeling for children have never been examined .
-METHODS	We conducted a national survey of 1000 parents randomized to 1 of 4 fast food menus : no labels , calories only , calories plus minutes , or calories plus miles needed to walk to burn the calories .
-METHODS	Respondents were asked to imagine they were in a fast food restaurant and place an order for their child .
-METHODS	At the survey 's conclusion , all respondents were shown a calorie-only label and both PACE labels and asked to rate the likelihood each label would influence them to encourage their child to exercise .
-RESULTS	We excluded respondents whose meals totaled 0 calories or > 4000 calories , leaving 823 parents in the analysis .
-RESULTS	The mean age of the child for whom the meal was `` ordered '' was 9.5 years .
-RESULTS	Parents whose menus displayed no label ordered an average of 1294 calories , whereas those shown calories only , calories plus minutes , or calories plus miles ordered 1066 , 1060 , and 1099 calories , respectively ( P = .0001 ) .
-RESULTS	Only 20 % of parents reported that calories-only labeling would be `` very likely '' to prompt them to encourage their children to exercise versus 38 % for calories plus minutes ( P < .0001 ) and 37 % for calories plus miles ( P < .0001 ) .
-CONCLUSIONS	PACE labeling may influence parents ' decisions on what fast food items to order for their children and encourage them to get their children to exercise .
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-###25840543
-BACKGROUND	Recurrent laryngeal nerve palsy ( RLNP ) and hypoparathyroidism are complications of thyroid surgery .
-BACKGROUND	The convalescence can depend on several factors ( ie , pain , fatigue , nausea , and vomiting ) .
-BACKGROUND	Supplemental oxygen improves inflammatory and immune function and decreases nausea and vomiting after surgical procedures .
-BACKGROUND	We have investigated whether supplemental perioperative oxygen administration could improve surgical outcomes in patients undergoing thyroid surgery .
-METHODS	Three hundred and sixty patients were randomized to an oxygen/air mixture with a fraction of inspired oxygen ( FiO2 ) of 30 % ( n = 179 ) or 80 % ( n = 181 ) .
-METHODS	Administration was commenced after induction of anesthesia and maintained for 6 hours after surgery .
-METHODS	The primary end points were temporary or permanent RLNP and transient or definitive hypoparathyroidism .
-METHODS	Pain and fatigue scores , nausea , and the number of vomiting episodes were also registered .
-METHODS	Preoperatively and at several times during the first 24 postoperative hours , we measured C-reactive protein , interleukin ( IL ) -6 , and IL1 levels .
-RESULTS	In the 80 % FiO2 group , the rate of temporary RLNP ( 4.4 % ) was significantly lower compared with the 30 % FiO2 group ( 9.4 % ) ( p = 0.040 ) .
-RESULTS	In addition , postoperative transient biochemical hypoparathyroidism occurred more frequently in the 30 % FiO2 group ( 48.5 % ) than in the 80 % FiO2 group ( 16.3 % ) ( p = 0.046 ) .
-RESULTS	Supplemental 80 % FiO2 significantly reduced postoperative levels of C-reactive protein ( p < 0.01 ) , IL6 and IL1 ( p < 0.05 ) , fatigue ( p < 0.01 ) , and overall pain during the first 24 postoperative hours ( p < 0.01 ) .
-RESULTS	Supplemental 80 % FiO2 also reduced nausea and vomiting on the day of operation ( p = 0.058 ) .
-CONCLUSIONS	Supplemental 80 % FiO2 reduced postoperative temporary RLNP and hypoparathyroidism rates and reduced pain , fatigue , nausea , and vomiting after thyroid surgery .
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-###25287853
-BACKGROUND	Treatment of patients with multimorbidity is challenging .
-BACKGROUND	A rational reduction of long-term drugs can lead to decreased mortality , less acute hospital treatment , and a reduction of costs .
-BACKGROUND	Simplification of drug treatment schemes is also related to higher levels of patient satisfaction and adherence .
-BACKGROUND	The POLITE-RCT trial will test the effectiveness of an intervention aiming at reducing the number of prescribed long-term drugs among multimorbid and chronically ill patients .
-BACKGROUND	The intervention focuses on the interface between primary and secondary health care and includes a pharmacist-based , patient-centered medication review prior to the patient 's discharge from hospital .
-METHODS	The POLITE-RCT trial is a cluster randomized controlled trial .
-METHODS	Two major secondary health care providers of Mecklenburg-Western Pomerania , Germany , take part in the study .
-METHODS	Clusters are wards of both medical centers .
-METHODS	All wards where patients with chronic diseases and multimorbidity are regularly treated will be included .
-METHODS	Patients aged 65 + years who take five or more prescribed long-term drugs and who are likely to spend at least 5 days in the participating hospitals will be recruited and included consecutively .
-METHODS	Cluster-randomization takes place after a six-month baseline data collection period .
-METHODS	Patients of the control group receive care as usual .
-METHODS	The independent two main primary outcomes are ( 1 ) health-related quality of life ( EQ-5D ) and ( 2 ) the difference in the number of prescribed long-term pharmaceutical agents between intervention and control group .
-METHODS	The secondary outcomes are appropriateness of prescribed medication ( PRISCUS list , Beers Criteria , MAI ) , patient satisfaction ( TSQM ) , patient empowerment ( PEF-FB-9 ) , patient autonomy ( IADL ) , falls , re-hospitalization , and death .
-METHODS	The points of measurement are at admission to ( T0 ) and discharge from hospital ( T1 ) as well as 6 and 12 months after discharge from the hospital ( T2 and T3 ) .
-METHODS	In 42 wards , 1,626 patients will be recruited .
-CONCLUSIONS	In case of positive evaluation , the proposed study will provide evidence for a sustainable reduction of polypharmacy by enhancing patient-centeredness and patient autonomy .
-BACKGROUND	Current Controlled Trials ISRCTN42003273 .
-
-###24612546
-BACKGROUND	AST1306 is an orally active irreversible small molecule inhibitor of EGFR ( erbB1 ) , HER2 ( erbB2 ) and HER4 ( erbB4 ) signaling .
-BACKGROUND	This is a phase I , open-label , dose-escalation study to evaluate the safety and tolerability , pharmacokinetics ( PK ) , and preliminary anti-tumor effects of oral AST1306 .
-BACKGROUND	In addition the effects of food on PK was tested .
-METHODS	A modified Fibonacci 3 plus 3 dose-escalation design was employed to determine the dose-limiting toxicity ( DLT ) and recommended phase II dose ( RP2D ) in patients with advanced solid tumors .
-METHODS	The following dose levels were investigated : once daily ( QD ) at two dose levels ( 400-and 800 mg ) , twice daily ( BID ) in five dose levels ( 600 - , 800 - , 1000 - , 1200 - and 1500 mg ) , and three times daily ( TID ) in three dose levels ( 800 - , 1000 - and 1200 mg ) .
-METHODS	In the PK and extension study , at least eight patients per dose cohort in three dose levels ( maximum tolerated dose [ MTD ] , one or two doses level lower than the MTD ) were enrolled to evaluate the PK profiles .
-RESULTS	Seventy-one patients were enrolled , with breast ( n = 22 ) and lung cancers ( n = 14 ) being the most common primary cancers .
-RESULTS	The most frequent drug-related adverse events were grade 1 to 3 diarrhea and rash , grade 1 to 2 fatigue .
-RESULTS	During dose escalation , the key DLT was grade 3 diarrhea observed in 5 patients at 1000 mg BID ( n = 1 ) , 1500 mg BID ( n = 1 ) , 800 mg TID ( n = 1 ) and 1200 mg TID ( n = 2 ) .
-RESULTS	AST1306 was rapidly absorbed and had moderate to high clearance .
-RESULTS	PK concentration parameters increased with dose over the range evaluated , with no evidence of accumulation over time .
-RESULTS	Under fed conditions , the mean T ( max ) was prolonged , C ( max ) was increased , and AUC ( 0 - ) was raised .
-RESULTS	Of the 55 evaluable patients , 7 patients experienced partial responses , including 5 with breast cancer , 1 with lung cancer , and 1 with gastric cancer .
-RESULTS	The best response with stable disease for6 months was achieved in 7 patients .
-CONCLUSIONS	Based on the DLT and PK profile , the RP2D was defined as 1000 mg TID with evidence of preliminary anti-tumor activity .
-CONCLUSIONS	Further studies are recommended .
-
-###24281236
-OBJECTIVE	This study aimed to assess the efficacy and safety of flibanserin , a serotonin receptor 1A agonist/serotonin receptor 2A antagonist , in postmenopausal women with hypoactive sexual desire disorder ( HSDD ) .
-METHODS	Naturally postmenopausal women with HSDD received flibanserin 100 mg once daily at bedtime ( n = 468 ) or placebo ( n = 481 ) for 24 weeks .
-METHODS	Co-primary endpoints were changes from baseline to week 24 in the number of satisfying sexual events ( SSEs ) across 28 days and in the Female Sexual Function Index ( FSFI ) desire domain score .
-METHODS	Secondary endpoints included change from baseline in Female Sexual Distress Scale-Revised ( FSDS-R ) Item 13 score ( which assesses distress due to low sexual desire ) , FSDS-R total score , and FSFI total score .
-METHODS	The Patient Benefit Evaluation was asked on treatment discontinuation .
-RESULTS	There were significant improvements with flibanserin versus placebo in the mean ( SE ) changes in the number of SSEs ( 1.0 [ 0.1 ] vs 0.6 [ 0.1 ] ) , FSFI desire domain score ( 0.7 [ 0.1 ] vs 0.4 [ 0.1 ] ) , FSDS-R Item 13 score ( -0.8 [ 0.1 ] vs -0.6 [ 0.1 ] ) , FSDS-R total score ( -8.3 [ 0.6 ] vs -6.3 [ 0.6 ] ) , and FSFI total score ( 4.2 [ 0.4 ] vs 2.7 [ 0.4 ] ; all P < 0.01 ) .
-RESULTS	More women on flibanserin ( 37.6 % ) than women on placebo ( 28.0 % ) reported experiencing meaningful benefits from the study medication on treatment discontinuation .
-RESULTS	The most frequent adverse events associated with flibanserin were dizziness , somnolence , nausea , and headache .
-CONCLUSIONS	In naturally postmenopausal women with HSDD , flibanserin , compared with placebo , has been associated with improvement in sexual desire , improvement in the number of SSEs , and reduced distress associated with low sexual desire , and is well tolerated .
-
-###25350224
-OBJECTIVE	Gemigliptin is a selective DPP4 inhibitor used to treat type 2 diabetes .
-OBJECTIVE	The objective of this study was to evaluate the pharmacokinetics ( PKs ) of gemigliptin , rosuvastatin , and irbesartan monotherapies and combination therapies .
-METHODS	Randomized , open-label , three-treatment , six-sequence , three-period , crossover studies were performed on healthy male volunteers .
-METHODS	The three treatments were : 50mg gemigliptin alone ; 20mg rosuvastatin ( part A ) or 300mg irbesartan alone ( part B ) ; and rosuvastatin or irbesartan with concomitant gemigliptin .
-METHODS	Each drug was administered as part of once daily , 7 day , repeated dosing regimens with a 14 day washout period .
-BACKGROUND	NCT01823133 ( part A ) and NCT01825850 ( part B ) .
-METHODS	The primary PK parameters - Cmax and AUC - were compared to the geometric mean ratios ( GMRs ) and 90 % confidence intervals ( 90 % CIs ) that were determined for the combination therapies and monotherapies .
-RESULTS	A total of 60 participants were administered the study drugs , and 52 participants ( 27 participants in part A ; 25 participants in part B ) were analyzed as part of the PK dataset .
-RESULTS	In part A , the GMRs ( gemigliptin + rosuvastatin/gemigliptin ) of the Cmax and AUC values of gemigliptin were 0.955 ( 90 % CI = 0.874-1 .044 ) and 1.023 ( 90 % CI = 0.991-1 .057 ) , and those of rosuvastatin were 1.012 ( 90 % CI = 0.946-1 .084 ) and 1.086 ( 90 % CI = 1.032-1 .142 ) , respectively .
-RESULTS	In part B , the GMRs of the Cmax and AUC values of gemigliptin were 1.046 ( 90 % CI = 0.964-1 .134 ) and 1.035 ( 90 % CI = 1.005-1 .065 ) , and those of irbesartan were 0.966 ( 90 % CI = 0.897-1 .040 ) and 1.050 ( 90 % CI = 0.993-1 .111 ) , respectively .
-RESULTS	The limitations of this study include its relatively short treatment period and small sample size , as only healthy participants were included .
-CONCLUSIONS	Gemigliptin does not affect the PK properties of rosuvastatin or irbesartan ; also , rosuvastatin and irbesartan do not affect the PKs of gemigliptin .
-
-###25154849
-OBJECTIVE	To evaluate the effects of continuous paravertebral nerve block after nephrectomy .
-METHODS	60 cases receiving simple nephrectomy , American Society of Anesthesiologists ( ASA ) grading status I or II , aged from 30 to 65 years , weighing from 45 to 80 kg , male or female , were randomly divided into 2 groups : control group ( CEA group ) and continuous paravertebral nerve block group ( PVB group ) , 30 patients in each one .
-METHODS	Both groups were performed with 0.2 % ropivacaine 250 ml in continuous infusion , assisted with intravenous morphine patient-controlled analgesia .
-METHODS	The blood gas was examined in 6 , 12 , 24 and 48 h postoperatively , and the VAS scores of quiet state and motion state were assessed.In 48 h postoperation , the total amount of morphine was calculated and the complications cases were recorded .
-RESULTS	Compared with the CEA group , PaO2 in PVB group increased and PaCO2 declined significantly .
-RESULTS	There was no difference of VAS score under quiet state , but under the motion state the VAS scores declined significantly , the total amount of morphine reduced [ ( 5.2 1.2 ) vs ( 13.9 1.6 ) mg ) ] , the cases of nausea , vomiting , pruritus , orthostatic hypotension decreased and the postoperative first anal exhaust time interval shortened ( P < 0.05 ) .
-CONCLUSIONS	Compared with CEA , postoperative administration of PVB for open nephrectomy results in lowering morphine dose as well as side effect related with the use of morphine .
-
-###24520943
-OBJECTIVE	To compare the image quality , evaluability , diagnostic accuracy , and radiation exposure of high-spatial-resolution ( HR , 0.23-mm ) computed tomographic ( CT ) coronary angiography with standard spatial resolution ( SR , 0.625-mm ) 64-section imaging in patients at high risk for coronary artery disease ( CAD ) by using invasive coronary angiography ( ICA ) as the reference method .
-METHODS	Written informed consent was obtained from all patients , and the study protocol was approved by the institutional ethical committee .
-METHODS	Patients at high risk for CAD ( n = 184 ) who were scheduled for ICA were randomly assigned for study with SR ( n = 91 ) or HR ( n = 93 ) coronary CT angiography before they underwent ICA .
-METHODS	To compare the two groups , the Student t test or Wilcoxon test were used to evaluate differences in continuous variables .
-METHODS	The ( 2 ) test or Fisher exact test were used , as appropriate , for categorical data .
-METHODS	The McNemar test was used to compare the diagnostic performance of coronary CT angiography versus that of ICA in each group .
-RESULTS	HR coronary CT angiography showed a higher image quality score ( 3.7 vs 3.4 , P < .001 ) and evaluability ( 97 % vs 92 % , P < .002 ) .
-RESULTS	In a segment-based analysis , HR coronary CT angiography showed a higher specificity , positive predictive value , and accuracy in comparison with SR coronary CT angiography ( 98 % , 91 % , and 99 % vs 95 % , 80 % , and 95 % , respectively ; P < .001 ) .
-RESULTS	Moreover , HR coronary CT angiography showed a better agreement with ICA for calcified plaques compared with SR coronary CT angiography and ICA ( 83 % vs 53 % , P < .001 ) .
-RESULTS	In a patient-based analysis , HR coronary CT angiography showed higher specificity and accuracy compared with SR coronary CT angiography ( 91 % and 98 % vs 46 % and 92 % , respectively ; P < .01 ) .
-RESULTS	No differences in radiation exposure were found between the two groups .
-CONCLUSIONS	Improved evaluability and accuracy were seen with HR compared with SR coronary CT angiography of calcified coronary artery lesions , suggesting a potential use for this technology in patients at high risk for CAD .
-
-###25750280
-BACKGROUND	Live animal studies using an inoculation model of breast cancer indicate that anaesthetic drugs and techniques differentially affect cancer metastasis , inversely related to Natural Killer ( NK ) cell and T lymphocyte levels .
-BACKGROUND	Clinical histological studies demonstrate that the distribution of these immune cells and macrophages in intra-tumoral cancer tissue can predict prognosis and response to therapy .
-BACKGROUND	No study has evaluated whether the anaesthetic technique influences human breast cancer immune cell infiltration .
-METHODS	Excised breast cancer specimens from patients previously enrolled in an ongoing , prospective , randomised trial ( NCT00418457 ) investigating the effect of anaesthetic technique on long-term breast cancer outcome were immunohistochemically stained to enable a colour deconvolution technique to summate marked immune cell infiltration : CD56 ( NK cells ) , CD4 ( T helper cells ) , CD8 ( T suppressor cells ) and CD68 ( macrophages ) .
-METHODS	Patients were randomised to receive either a propofol-paravertebral anaesthetic with continuing analgesia ( PPA , n = 12 ) or a balanced general anaesthesia with opioid analgesia ( GA , n = 16 ) for 24 h postoperatively .
-METHODS	Investigators were masked to group allocation .
-RESULTS	Normalised positive intensity values , ( median ( interquartile range ( IQR ) ) , for CD56 were lower in GA121 ( 116-134 ) versus 136 ( 132-142 ) , p = 0.015 .
-RESULTS	CD4 was also lower in GA10 .9 ( 5.5-27 .8 ) versus PPA 19.7 ( 14.4-83 .5 ) , p = 0.03 but CD8 5.5 ( 4.0-9 .75 ) versus 13.0 ( 5.0-14 .5 ) respectively , p = 0.24 and CD 68 infiltration 5.8 ( 3.25-8 .75 ) versus 8.0 ( 3.0-8 .75 ) , p = 0.74 were not significantly different .
-CONCLUSIONS	PPA induces increased levels of NK and T helper cell infiltration into breast cancer tissue compared with GA but not T suppressor cells or macro phages .
-CONCLUSIONS	This is consistent with the hypothesis that the anaesthetic technique may affect perioperative immune function conducive to resisting breast cancer recurrence and metastasis .
-
-###25188543
-BACKGROUND	Civilian posttraumatic stress disorder ( PTSD ) and combat PTSD are major public health concerns .
-BACKGROUND	Although a number of psychosocial risk factors have been identified related to PTSD risk , there are no accepted , robust biological predictors that identify who will develop PTSD or who will respond to early intervention following trauma .
-BACKGROUND	We wished to examine whether genetic risk for PTSD can be mitigated with an early intervention .
-METHODS	65 emergency department patients recruited in 2009-2010 at Grady Memorial Hospital in Atlanta , Georgia , who met criterion A of DSM-IV PTSD received either 3 sessions of an exposure intervention , beginning in the emergency department shortly after trauma exposure or assessment only .
-METHODS	PTSD symptoms were assessed 4 and 12 weeks after trauma exposure .
-METHODS	A composite additive risk score was derived from polymorphisms in 10 previously identified genes associated with stress-response ( ADCYAP1R1 , COMT , CRHR1 , DBH , DRD2 , FAAH , FKBP5 , NPY , NTRK2 , and PCLO ) , and gene x treatment effects were examined .
-METHODS	The intervention included 3 sessions of imaginal exposure to the trauma memory and additional exposure homework .
-METHODS	The primary outcome measure was the PTSD Symptom Scale-Interview Version or DSM-IV-based PTSD diagnosis in patients related to genotype and treatment group .
-RESULTS	A gene x intervention x time effect was detected for individual polymorphisms , in particular the PACAP receptor , ADCYAP1R1 , as well as with a combined genotype risk score created from independent SNP markers .
-RESULTS	Subjects who did not receive treatment had higher symptoms than those who received intervention .
-RESULTS	Furthermore , subjects with the `` risk '' genotypes who did not receive intervention had higher PTSD symptoms compared to those with the `` low-risk '' or `` resilience '' genotypes or those who received intervention .
-RESULTS	Additionally , PTSD symptoms correlated with level of genetic risk at week 12 ( P < .005 ) in the assessment-only group , but with no relationship in the intervention group , even after controlling for age , sex , race , education , income , and childhood trauma .
-RESULTS	Using logistic regression , the number of risk alleles was significantly associated with likelihood of PTSD diagnosis at week 12 ( P < .05 ) .
-CONCLUSIONS	This pilot prospective study suggests that combined genetic variants may serve to predict those most at risk for developing PTSD following trauma .
-CONCLUSIONS	A psychotherapeutic intervention initiated in the emergency department within hours of the trauma may mitigate this risk .
-CONCLUSIONS	The role of genetic predictors of risk and resilience should be further evaluated in larger , prospective intervention and prevention trials .
-BACKGROUND	ClinicalTrials.gov identifier : NCT00895518 .
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-###25362668
-BACKGROUND	Despite the general belief that mobility and exercise play an important role in the recovery of functional status , mobility is difficult to implement in patients in intensive care units .
-OBJECTIVE	To compare a mobility platform with standard equipment , assessing efficiency ( decreased time and staff required to prepare patient ) , effectiveness ( increased activity time ) , and safety ( no falls , unplanned tube removals , or emergency situations ) for intensive care patients .
-METHODS	This observational study was approved by the institutional review board , and informed consent was obtained from the patient or the medical decision maker .
-METHODS	Intensive care patients were assigned to a room in the usual manner , with platforms in odd-numbered rooms and standard equipment in even-numbered rooms .
-METHODS	Standardized data collection tools were designed to collect data for 24 hours for each patient .
-METHODS	The nurses caring for the patients completed the data collection tools in real time during the activity .
-METHODS	The stages of activity and the physiological states that would preclude mobility were very specifically defined for the research study .
-RESULTS	Data were collected for a total of 71 patients and 238 activities .
-RESULTS	Important ( although not significant ) descriptive statistics regarding early mobility in the intensive care unit were discovered .
-RESULTS	The unintended result of the research study was a change in the culture and practice regarding early mobility in the intensive care unit .
-CONCLUSIONS	Early mobility can be implemented in intensive care units .
-CONCLUSIONS	Standard equipment can be used to mobilize such patients safely ; however , for patients who ambulate , a platform may increase efficiency and effectiveness .
-
-###24368488
-OBJECTIVE	This study aimed to compare sexual function before and 1 year after laparoscopic sacrocolpopexy using a porcine dermis or a polypropylene mesh material .
-METHODS	This was a secondary analysis of sexual function measured before and 1 year after laparoscopic sacrocolpopexy in a group of 81 sexually active women participating in a randomized controlled trial comparing porcine dermis and polypropylene mesh .
-METHODS	Sexual function was assessed using the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire ( PISQ-12 ) .
-METHODS	Responses to individual questions from the physical domain of the PISQ-12 were also analyzed .
-METHODS	Additional information included the type of mesh material used and whether a concomitant suburethral sling or perineorrhaphy was performed .
-RESULTS	There was a significant postoperative improvement in total PISQ-12 scores for the entire cohort ( 33.2 vs 38.3 , P < 0.01 ) .
-RESULTS	Similarly , PISQ-12 scores were significantly improved in both groups ( 33.2 preoperative vs 37.4 one year postoperative in the porcine dermis , P < 0.01 and 33.2 vs 39.2 in the polypropylene mesh , P < 0.01 ) .
-RESULTS	There were no differences between the 2 graft material groups .
-RESULTS	Preoperatively , 63.0 % ( 48/76 ) of women reported avoiding sexual intercourse because of bulging in vagina ( PISQ12-question # 8 ) , at 1 year postoperatively only 4 % ( 3/76 ) had a positive response ( P < 0.01 ) .
-RESULTS	We observed a significant decrease in the number of women who reported pain during intercourse at 12 months as evidenced by the responses to the PISQ12-question # 5 , 47.4 % ( 36/76 ) versus 26.3 % ( 20/76 ) ( P < 0.01 ) .
-RESULTS	The addition of a suburethral sling or a perineorrhaphy did not negatively impact sexual function at 1 year .
-CONCLUSIONS	Laparoscopic sacrocolpopexy had a positive impact on sexual function at 1 year regardless of whether a porcine dermis or a polypropylene mesh material was used .
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-###25084830
-BACKGROUND	The objective of this study was to investigate the effects of feeding a high-concentrate corn straw diet on the release of endotoxin in the rumen and the changes of pro-inflammatory cytokines in the mammary gland of dairy cows in comparison with a low-concentrate corn straw diet and a low-concentrate mixed forage diet .
-BACKGROUND	Thirty second-parity Chinese Holstein cows in mid-lactation with a body condition score of 2.860.29 , weighing 54357kg and producing 24.323.86 kg milk per day were randomly assigned to 1 of the 3 diets ( n = 10 per treatment ) : 1 ) low-concentrate mixed forage diet ( LCF ) with a concentrate to roughage ratio of 46 : 54 ; 2 ) high-concentrate corn straw diet ( HCS ) with a concentrate to roughage ratio of 65 : 35 ; 3 ) low-concentrate corn straw diet ( LCS ) with the same concentrate to roughage ratio ( 46 : 54 ) as LCF .
-BACKGROUND	The experiment lasted 6weeks , and samples were collected in the last week .
-BACKGROUND	Milk samples were analyzed for conventional components , rumen fluid samples were analyzed for pH and endotoxin , and mammary arterial and venous plasma samples were analyzed for concentrations of interleukin ( IL ) -1 , IL-6 , IL-8 and tumor necrosis factor alpha ( TNF - ) .
-RESULTS	Concentrations of endotoxin in rumen fluid and feces of cows fed HCS were significantly higher than those of cows fed LCS and LCF .
-RESULTS	Feeding HCS increased the release of IL-1 , IL-6 and IL-8 in the mammary gland compared with feeding LCS .
-RESULTS	Concentrations of cytokines ( IL-1 and IL-8 ) in mammary venous plasma had a negative correlation with milk production efficiencies .
-CONCLUSIONS	Results indicated that the high-concentrate corn straw diet increased the concentrations of endotoxin in rumen fluid and feces .
-CONCLUSIONS	Furthermore , feeding the high-concentrate corn straw diet stimulated the mammary gland to release more pro-inflammatory cytokines .
-CONCLUSIONS	The results suggest that feeding a high-concentrate corn straw diet induce a higher pro-inflammatory response in the mammary gland and thus may partly decrease the milk production efficiencies in dairy cows .
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-###24744272
-BACKGROUND	Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation ( AF ) .
-BACKGROUND	The periprocedural anticoagulation management could play a role in the incidence of these complications .
-BACKGROUND	Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk , no randomized study exists .
-RESULTS	This was a prospective , open-label , randomized , parallel-group , multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation .
-RESULTS	Patients with CHADS2 score 1 were included .
-RESULTS	Patients were randomly assigned in a 1:1 ratio to the off-warfarin or on-warfarin arm .
-RESULTS	The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study .
-RESULTS	The study enrolled 1584 patients : 790 assigned to discontinue warfarin ( group 1 ) and 794 assigned to continuous warfarin ( group 2 ) .
-RESULTS	No statistical difference in baseline characteristics was observed .
-RESULTS	There were 39 thromboembolic events ( 3.7 % strokes [ n = 29 ] and 1.3 % transient ischemic attacks [ n = 10 ] ) in group 1 : two events ( 0.87 % ) in patients with paroxysmal AF , 4 ( 2.3 % ) in patients with persistent AF , and 33 ( 8.5 % ) in patients with long-standing persistent AF .
-RESULTS	Only 2 strokes ( 0.25 % ) in patients with long-standing persistent AF were observed in group 2 ( P < 0.001 ) .
-RESULTS	Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism ( odds ratio , 13 ; 95 % confidence interval , 3.1-55 .6 ; P < 0.001 ) .
-CONCLUSIONS	This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01006876 .
-
-###24983707
-OBJECTIVE	Exercise maintenance after completing phase II cardiac rehabilitation ( CR ) is challenging for many patients .
-OBJECTIVE	A telephone-based maintenance intervention improved exercise participation compared with a control group at 12 months post-CR discharge .
-OBJECTIVE	We examined the 6-month mediators of intervention effects on exercise .
-METHODS	In a randomized controlled trial , 130 patients who had completed CR ( mean age : 63.6 [ SD = 9.7 ] years , 20.8 % female ) were randomized to Maintenance Counseling ( n = 64 ) or Contact Control ( n = 66 ) .
-METHODS	Putative mediators examined the following : self-efficacy , behavioral processes of change , decisional balance index , social support for exercise , and enjoyment of exercise .
-RESULTS	Multiple mediation analyses showed that the intervention significantly increased social support from friends at 6 months but not the other constructs .
-RESULTS	Decreasing support from friends mediated greater exercise participation in Maintenance Counseling than in Contact Control at 12 months .
-CONCLUSIONS	Social support from friends functioned as a suppressor mediator for exercise maintenance among cardiac patients .
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-###25143165
-OBJECTIVE	To explore the effect of single-dose dexmedetomidine on recovery period after sevoflurane anesthesia with spontaneous respiration in pediatric patients undergoing cleft lip and palate repair .
-METHODS	A total of 60 American Society of Anesthesiologists ( ASA ) I-II pediatric patients undergoing cleft lip and palate repair from October to December 2013 were randomly divided into groups D and C ( n = 30 each ) .
-METHODS	Dexmedetomidine 0.5 g/kg ( group D ) or an equal volume of normal saline ( group C ) was ad ministered intravenously over a period of 10 min at 30 min before the end of surgery .
-METHODS	Anesthesia was induced and maintained with sevoflurane under spontaneous ventilation .
-METHODS	Heart rate , mean arterial pressure ( MAP ) , hemoglobin oxygen saturation ( SpO2 ) , respiratory rate , tidal volume ( VT ) and pressure of end-tidal carbon dioxide ( PETCO2 ) were recorded at the time before induction ( T0 ) , 30 min before the end of surgery ( T1 ) , 20 min before the end of surgery ( T2 ) , 15 min before the end of surgery ( T3 ) , 10 min before the end of surgery ( T4 ) , the end of surgery ( T5 ) , extubation ( T6 ) , 5 min after transferal into post-anesthesia care unit ( PACU ) ( T7 ) , 1 h after surgery ( T8 ) , extubation time , length of PACU stay , fentanyl consumption and adverse events were all recorded .
-METHODS	The incidence and severity of coughing and emergence agitation were assessed .
-RESULTS	Compared to T0 , MAP and heart rate at T1 to T5 all decreased in two groups ( P < 0.05 ) .
-RESULTS	MAP and heart rate at T6 both increased in two groups and group C was higher than group D ( P < 0.05 ) .
-RESULTS	No inter-group differences existed in SpO2 , respiratory rate , VT or PETCO2 .
-RESULTS	The incidence of coughing and emergence agitation ( 30 % and 13.3 % ) , fentanyl consumption of group D ( 0.8 2.1 g ) were all significantly lower than that of group C [ ( 66.7 % vs 56.7 % ) and ( 4.9 6.50 ) g , P < 0.05 ] .
-RESULTS	Length of PACU stay in group D was shorter than that in group C [ ( 15 6 ) vs ( 23 19 ) min , P < 0.05 ] .
-RESULTS	No inter-group difference existed in extubation time or adverse events .
-CONCLUSIONS	A single intravenous dose of dexmedetomidine is effective in reducing emergence agitation and coughing , shortening length of PACU stay and improving the quality of recovery period after sevoflurane anesthesia in pediatric patients undergoing cleft lip and palate repair .
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-###25450133
-OBJECTIVE	To test whether subsensory vibratory noise applied to the sole of the foot using a novel piezoelectric vibratory insole can significantly improve sensation , enhance balance , and reduce gait variability in elderly people , as well as to determine the optimal level of vibratory noise and whether the therapeutic effect would endure and the user 's sensory threshold would remain constant during the course of a day .
-METHODS	A randomized , single-blind , crossover study of 3 subsensory noise stimulation levels on 3 days .
-METHODS	Balance and gait laboratory .
-METHODS	Healthy community-dwelling elderly volunteers ( N = 12 ; age , 65-90y ) who could feel the maximum insole vibration .
-METHODS	A urethane foam insole with the piezoelectric actuators delivering subsensory vibratory noise stimulation to the soles of the feet .
-METHODS	Balance , gait , and timed Up and Go ( TUG ) test .
-RESULTS	The vibratory insoles significantly improved performance on the TUG test , reduced the area of postural sway , and reduced the temporal variability of walking at both 70 % and 85 % of the sensory threshold and during the course of a day .
-RESULTS	Vibratory sensation thresholds remained relatively stable within and across study days .
-CONCLUSIONS	This study provides proof of concept that the application of the principle of stochastic resonance to the foot sole sensory system using a new low-voltage piezoelectric technology can improve measures of balance and gait that are associated with falls .
-CONCLUSIONS	Effective vibratory noise amplitudes range from 70 % to 85 % of the sensory threshold and can be set once daily .
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-###25041807
-OBJECTIVE	One of the primary goals of endoscopic sinus surgery ( ESS ) is to create widely patent paranasal sinus ostia , but lateralization of the middle turbinate ( MT ) after ESS can obstruct otherwise patent ethmoid and maxillary sinuses .
-OBJECTIVE	The aim of this study was to evaluate the effectiveness of turbinate-septal suturing in preventing lateralization of the MT.
-METHODS	A prospective , randomized , blinded controlled study .
-METHODS	The study was performed in 120 patients who had undergone ESS .
-METHODS	The patients were randomized to receive nasal ( group A ) or turbinate-septal suture plus nasal packing ( group B ) .
-METHODS	Postoperative lateralization of the MT and synechia formation were assessed as the primary outcome 3 months post-ESS .
-METHODS	The Lund-Kennedy Scores at 1 week , 2 week , and 1 month after ESS were assessed as the secondary outcomes .
-RESULTS	A total of 120 patients were enrolled ( 60 patients in each group ) .
-RESULTS	Group B had a significantly lower rate of MT lateralization compared to group A after 3 months of surgery ( 6 of 120 sides vs. 19 of 120 sides ; P < 0.01 ) .
-RESULTS	Synechia formation rates in groups B were also significantly lower than those in group A ( 4 of 120 sides vs. 13 of 120 sides ; P = 0.023 ) .
-CONCLUSIONS	Middle turbinate-septal suturing medialization during ESS is an effective method for preventing lateralization of the MT.
-
-###25636291
-OBJECTIVE	To investigate the effect of `` Xinjingjie compound lysostaphin antibacterial collutorium '' on prevention and treatment of radiation-induced oral mucositis in a prospective , randomized and double-blind clinical trial .
-METHODS	Sixty patients with oral cancer to be treated with radiotherapy were randomized into the experimental and control group .
-METHODS	The experimental group ( 30 patients ) was treated with `` Xinjingjie mouthrinse '' during the full course of radiotherapy , 4 times daily with 5 mL and 5 min each time .
-METHODS	The control group ( 30 patients ) rinsed the mouth in the same way with normal saline .
-METHODS	Oral mucositis was assessed according to the RTOG criteria .
-METHODS	The severity of mucositis and the degree of pain were recorded and photographed .
-METHODS	Patients should n't be treated with other drugs until the level of oral mucositis reached above grade III .
-METHODS	The results were statistically analyzed using Stata 12.0 software packages .
-RESULTS	Age , gender , radiotherapy techniques and dose showed no significant difference between the 2 groups ( P > 0.05 ) .
-RESULTS	The first onset of oral mucositis in the experimental group was later than that in the control group ( 11.0 times :9.1 times , P < 0.05 ) , and the incidence of pain at the early time of radiotherapy was lower ( 36.7 % : 70.0 % , P < 0.05 ) .
-RESULTS	Also , the onset time of grade III oral mucositis in the emperimental group was later than that in the control group ( 18.9 times :15.9 times , P < 0.05 ) , and the incidence of grade III oral mucositis in the experimental group was lower ( 63.3 % vs. 90.0 % , P < 0.05 ) .
-CONCLUSIONS	`` Xinjingjie mouthrinse '' is worthwhile to be used in clinic because it can delay the occurrence time of radiation-induced oral mucositis , alleviate pain and reduce the indication of grade III oral mucositis .
-
-###24656590
-OBJECTIVE	To assess the potential therapeutic effect of intratendinous injection of platelet-rich plasma ( PRP ) under ultrasound ( US ) guidance to treat tendon tears and tendinosis in a pilot study with long-term follow-up .
-METHODS	The study included 408 consecutive patients referred for treatment by PRP injection of tendinopathy in the upper ( medial and lateral epicondylar tendons ) and the lower ( patellar , Achilles , hamstring and adductor longus , and peroneal tendons ) limb who received a single intratendinous injection of PRP under US guidance .
-METHODS	Clinical and US data were retrospectively collected for each anatomic compartment for upper and lower limbs before treatment ( baseline ) and 6 weeks after treatment .
-METHODS	Late clinical data without US were collected until 32 months after the procedure ( mean , 20.2 months ) .
-METHODS	The McNemar test and regression model were used to compare clinical and US data .
-RESULTS	QuickDASH score , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) score , and residual US size of lesions were significantly lower after intratendinous injection of PRP under US guidance at 6 weeks and during long-term follow-up compared with baseline ( P < .001 in upper and lower limb ) independent of age , gender , and type of tendinopathy ( P > .29 ) .
-RESULTS	No clinical complication was reported during follow-up .
-CONCLUSIONS	Intratendinous injection of PRP under US guidance appears to allow rapid tendon healing and is well tolerated .
-
-###25162691
-OBJECTIVE	We compare the rate of return to the emergency department ( ED ) within 72 hours between families of children receiving a follow-up telephone call by a non-health care provider asking about the child 's well-being 12 hours after their visit to the ED and families not receiving a follow-up call .
-METHODS	This was a prospective , randomized study in which we conducted a follow-up call starting at 12 hours after discharge from the ED versus no call for follow-up .
-METHODS	At 96 hours after discharge , we contacted all recruited families .
-METHODS	We recorded the rate of return to the ED within 72 hours of discharge .
-RESULTS	Of 371 families in the data analysis , 46 % were in the study group , and 55.5 % were male patients .
-RESULTS	Mean age was 5.7 years .
-RESULTS	The outcome measure was found to be in contrary to our hypothesis .
-RESULTS	We found return visits to the ED in 24 ( 14 % ) of the children in the study group compared with only 14 ( 7 % ) in the control group ( P < 0.03 ) .
-RESULTS	All other parameters were not statistically different between the groups .
-CONCLUSIONS	Emergency departments practicing follow-up calls by non-health care providers should consider a forecasted increase in return rates .
-
-###25261009
-BACKGROUND	Inpatients are visited by many health care providers daily ; many can not remember the name of even one member of their clinical care team .
-BACKGROUND	We provided inpatients with photographs of their clinicians and evaluated the impact on patient recall and communication with their health care providers .
-METHODS	A concealed allocation , randomized controlled trial ( ClinicalTrials.gov NCT01658644 ) was conducted between September 2012 and April 2013 in the general internal medicine wards of a large teaching hospital in Toronto , Canada .
-METHODS	Consenting patients were randomized into 3 groups : the control group received the current standard of care ; the second group received handouts with the names and roles of their clinical care team ; and the third group received handouts with the names , roles , and photographs of their clinical care team .
-METHODS	Before discharge , patients completed a survey on their ability to recall their clinicians and were asked to rate the quality of communication with their care team .
-RESULTS	Of the 186 patients ( mean age 61 years , female = 44 % ) who completed surveys ( control n = 60 ; names n = 65 ; photos n = 61 ) , those receiving photos in the handout correctly identified significantly more clinicians by photograph ( P = .001 ) and recalled more names ( P = .002 ) than patients assigned to the control group .
-RESULTS	Regarding the perceived quality of communication , the results did not show differences between the control and intervention groups .
-CONCLUSIONS	In this era of patient-centered care , providing patients with more information about who is directly involved with their health care appears to be warranted .
-
-###24438039
-BACKGROUND	Primary Sjgren 's Syndrome ( PSS ) mainly affects women ( 9:1 female : male ratio ) and is one of the commonest autoimmune diseases with a prevalence of 0.1 - 0.6 % of adult women .
-BACKGROUND	For patients with PSS there is currently no effective therapy that can alter the progression of the disease .
-BACKGROUND	The aim of the TRACTISS study is to establish whether in patients with PSS , treatment with rituximab improves clinical outcomes .
-METHODS	TRACTISS is a UK multi-centre , double-blind , randomised , controlled , parallel group trial of 110 patients with PSS .
-METHODS	Patients will be randomised on a 1:1 basis to receive two courses of either rituximab or placebo infusion in addition to standard therapy , and will be followed up for up to 48 weeks .
-METHODS	The primary objective is to assess the extent to which rituximab improves symptoms of fatigue and oral dryness .
-METHODS	Secondary outcomes include ocular dryness , salivary flow rates , lacrimal flow , patient quality of life , measures of disease damage and disease activity , serological and peripheral blood biomarkers , and glandular histology and composition .
-CONCLUSIONS	The TRACTISS trial will provide direct evidence as to whether rituximab in patients with PSS leads to an improvement in patient symptoms and a reduction in disease damage and activity .
-BACKGROUND	UKCRN Portfolio ID : 9809 ISRCTN65360827 .
-
-###25830421
-BACKGROUND	The choice of empirical antibiotic treatment for patients with clinically suspected community-acquired pneumonia ( CAP ) who are admitted to non-intensive care unit ( ICU ) hospital wards is complicated by the limited availability of evidence .
-BACKGROUND	We compared strategies of empirical treatment ( allowing deviations for medical reasons ) with beta-lactam monotherapy , beta-lactam-macrolide combination therapy , or fluoroquinolone monotherapy .
-METHODS	In a cluster-randomized , crossover trial with strategies rotated in 4-month periods , we tested the noninferiority of the beta-lactam strategy to the beta-lactam-macrolide and fluoroquinolone strategies with respect to 90-day mortality , in an intention-to-treat analysis , using a noninferiority margin of 3 percentage points and a two-sided 90 % confidence interval .
-RESULTS	A total of 656 patients were included during the beta-lactam strategy periods , 739 during the beta-lactam-macrolide strategy periods , and 888 during the fluoroquinolone strategy periods , with rates of adherence to the strategy of 93.0 % , 88.0 % , and 92.7 % , respectively .
-RESULTS	The median age of the patients was 70 years .
-RESULTS	The crude 90-day mortality was 9.0 % ( 59 patients ) , 11.1 % ( 82 patients ) , and 8.8 % ( 78 patients ) , respectively , during these strategy periods .
-RESULTS	In the intention-to-treat analysis , the risk of death was higher by 1.9 percentage points ( 90 % confidence interval [ CI ] , -0.6 to 4.4 ) with the beta-lactam-macrolide strategy than with the beta-lactam strategy and lower by 0.6 percentage points ( 90 % CI , -2.8 to 1.9 ) with the fluoroquinolone strategy than with the beta-lactam strategy .
-RESULTS	These results indicated noninferiority of the beta-lactam strategy .
-RESULTS	The median length of hospital stay was 6 days for all strategies , and the median time to starting oral treatment was 3 days ( interquartile range , 0 to 4 ) with the fluoroquinolone strategy and 4 days ( interquartile range , 3 to 5 ) with the other strategies .
-CONCLUSIONS	Among patients with clinically suspected CAP admitted to non-ICU wards , a strategy of preferred empirical treatment with beta-lactam monotherapy was noninferior to strategies with a beta-lactam-macrolide combination or fluoroquinolone monotherapy with regard to 90-day mortality .
-CONCLUSIONS	( Funded by the Netherlands Organization for Health Research and Development ; CAP-START ClinicalTrials.gov number , NCT01660204 . )
-
-###24780955
-OBJECTIVE	Spinal cord stimulation is a potential therapeutic option for the treatment of Parkinson 's disease ( PD ) - associated symptoms .
-OBJECTIVE	Repetitive trans-spinal magnetic stimulation ( rTSMS ) is a non-invasive and safe alternative for stimulation of spinal pathways that has not been studied for therapeutic efficacy in PD .
-OBJECTIVE	We assessed the benefits of rTSMS on camptocormia , an often treatment-resistant postural abnormality observed in PD patients .
-METHODS	We compared rTSMS to sham stimulation in PD patients with camptocormia in a single-centre , randomised , single-blind , crossover , placebo-controlled study .
-METHODS	PD patients with camptocormia were administered a single trial of rTSMS ( a train of 40 stimuli ) or sham treatment followed 1 week later by the alternate treatment .
-METHODS	Primary outcome measure was thoracolumbar spine flexion angle in the standing position immediately after the trial .
-RESULTS	Of 320 PD patients examined , 37 had concomitant camptocormia and were randomly assigned to either the rTSMS first group ( n = 19 ) or sham first group ( n = 18 ) .
-RESULTS	Flexion angle in the standing position decreased by a mean of 10.9 ( 95 % CI 8.1 to 13.65 ) after rTSMS but remained unchanged after sham stimulation ( mean , -0.1 ; 95 % CI -0.95 to 0.71 ) .
-RESULTS	The flexion angle while sitting ( secondary outcome ) decreased by 8.1 ( 95 % CI 5.89 to 10.25 ) after rTSMS , whereas sham treatment had no significant effect ( mean , -0.8 ; 95 % CI -1.62 to 0.05 ) .
-CONCLUSIONS	We found an immediate beneficial effect of rTSMS on camptocormia in PD patients .
-CONCLUSIONS	Although the effect was transient , this successful trial justifies further studies to test if repeated rTSMS treatments can induce longer term improvements in camptocormia associated with PD .
-BACKGROUND	UMIN Clinical Trials Registry : UMIN000011495 .
-
-###24246378
-BACKGROUND	The SP790 study ( ClinicalTrials.gov , NCT00136045 ) showed benefits of rotigotine over placebo in improving symptom severity of restless legs syndrome ( RLS ) , also known as Willis-Ekbom disease , on the International Restless Legs Syndrome Study Group rating scale ( IRLS ) , Clinical Global Impression item 1 ( CGI-1 ) , RLS 6-item questionnaire ( RLS-6 ) , and the RLS-quality of life questionnaire ( RLS-QoL ) in patients with moderate to severe idiopathic RLS .
-BACKGROUND	To provide clinical context for the IRLS and to guide the choice of assessment scales for RLS studies , our post hoc analysis of SP790 data evaluated associations between the IRLS and the CGI-1 , IRLS and RLS-6 , and the IRLS and RLS-QoL .
-METHODS	Scale associations were analyzed at baseline and at the end of maintenance ( EoM ) using data from the safety set ( rotigotine and placebo groups combined [ n = 458 ] ) .
-METHODS	Changes from baseline to EoM in IRLS score vs comparator scale scores also were analyzed .
-RESULTS	There was a trend towards increasing IRLS severity category with increasing CGI-1 , RLS-6 , and RLS-QoL score .
-RESULTS	Pearson product moment correlation coefficients showed correlations between IRLS and comparator scale scores at baseline and EoM as well as correlations for change from baseline to EoM .
-CONCLUSIONS	Correlations between the IRLS and comparator scales were substantial .
-CONCLUSIONS	These data indicate that the IRLS is clinically meaningful .
-CONCLUSIONS	The IRLS and CGI-1 are generally sufficient to evaluate the overall severity and impact of RLS symptoms in clinical trials .
-
-###24534402
-OBJECTIVE	To evaluate sustained improvements 6 months after a 40-session , in-school computer attention training intervention using neurofeedback or cognitive training ( CT ) administered to 7 - to 11-year-olds with attention-deficit/hyperactivity disorder ( ADHD ) .
-METHODS	One hundred four children were randomly assigned to receive neurofeedback , CT , or a control condition and were evaluated 6 months postintervention .
-METHODS	A 3-point growth model assessed change over time across the conditions on the Conners 3-Parent Assessment Report ( Conners 3-P ) , the Behavior Rating Inventory of Executive Function Parent Form ( BRIEF ) , and a systematic double-blinded classroom observation ( Behavioral Observation of Students in Schools ) .
-METHODS	Analysis of variance assessed community-initiated changes in stimulant medication .
-RESULTS	Parent response rates were 90 % at the 6-month follow-up .
-RESULTS	Six months postintervention , neurofeedback participants maintained significant gains on Conners 3-P ( Inattention effect size [ ES ] = 0.34 , Executive Functioning ES = 0.25 , Hyperactivity/Impulsivity ES = 0.23 ) and BRIEF subscales including the Global Executive Composite ( ES = 0.31 ) , which remained significantly greater than gains found among children in CT and control conditions .
-RESULTS	Children in the CT condition showed delayed improvement over immediate postintervention ratings only on Conners 3-P Executive Functioning ( ES = 0.18 ) and 2 BRIEF subscales .
-RESULTS	At the 6-month follow-up , neurofeedback participants maintained the same stimulant medication dosage , whereas participants in both CT and control conditions showed statistically and clinically significant increases ( 9 mg [ P = .002 ] and 13 mg [ P < .001 ] , respectively ) .
-CONCLUSIONS	Neurofeedback participants made more prompt and greater improvements in ADHD symptoms , which were sustained at the 6-month follow-up , than did CT participants or those in the control group .
-CONCLUSIONS	This finding suggests that neurofeedback is a promising attention training treatment for children with ADHD .
-
-###24884848
-BACKGROUND	Over the years , there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture .
-BACKGROUND	It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5years without implant failures , when delayed loading was used .
-BACKGROUND	However , other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied .
-BACKGROUND	Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading .
-METHODS	This prospective nine-center randomized controlled clinical trial is still ongoing .
-METHODS	The final patient will complete the trial in 2016 .
-METHODS	In total , 180 edentulous patients between 60 and 89years with sufficient complete dentures will receive one median implant in the edentulous mandible , which will retain the existing complete denture using a ball attachment .
-METHODS	Loading of the median implant is either immediately after implant placement ( experimental group ) or delayed by 3months of submerged healing at second-stage surgery ( control group ) .
-METHODS	Follow-up of patients will be performed for 24months after implant loading .
-METHODS	The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group .
-METHODS	The secondary outcome measures encompass clinical , technical and subjective variables .
-METHODS	The study was funded by the Deutsche Forschungsgemeinschaft ( German research foundation , KE 477/8 -1 ) .
-CONCLUSIONS	This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded .
-CONCLUSIONS	If viable , this treatment option will strongly improve everyday dental practice .
-BACKGROUND	The trial has been registered at Deutsches Register Klinischer Studien ( German register of clinical trials ) under DRKS-ID : DRKS00003730 since 23 August 2012 .
-BACKGROUND	( http://www.germanctr.de ) .
-
-###24884624
-BACKGROUND	This prospective randomized study aimed to evaluate the role of WBRT+SRS compared to SRS alone and to WBRT alone in improvement of overall survival , brain local control and neurologic manifestations .
-METHODS	The trial included 60 patients with 1 to 3 brain metastases treated at the Radiotherapy Department , National Cancer Institute .
-METHODS	21 patients received WBRT+SRS , 18 patients received SRS alone and 21 patients received WBRT alone .
-RESULTS	Median local control was significantly better for WBRT+SRS compared to SRS alone & WBRT alone ( 10 vs 6 vs 5 months , respectively , P = 0.04 ) .
-RESULTS	There was non significant survival benefit for WBRT+SRS compared to SRS alone & WBRT alone .
-RESULTS	Survival was significantly better for patients with controlled primary tumor who received WBRT+SRS compared to SRS alone & WBRT alone ( median survival was 12 vs 5.5 vs 8 months , respectively .
-RESULTS	P = 0.027 ) .
-RESULTS	Regardless of the treatment group , median survival and median local control were highly significantly better for single brain site involvement compared to multiple brain sites involvement ( P = 0.003 & P = 0.001 , respectively ) , and median brain local control was significantly better for single lesion compared to multiple lesions ( P = 0.05 ) .
-CONCLUSIONS	WBRT+SRS is an effective , safe tool in treatment of patients with 1 to 3 brain metastses improving the brain local control , but further studies with larger number of patients is recommended .
-
-###24849077
-BACKGROUND	Depressive symptoms and reduced quality of life ( QOL ) are parts of the chronic stress syndrome and predictive of adverse outcome in patients with ischemic heart disease ( IHD ) .
-BACKGROUND	Chronic stress is associated with increased sensitivity for pain , which can be measured by algometry as Pressure Pain Sensitivity ( PPS ) on the sternum .
-OBJECTIVE	To evaluate if stress focus by self-measurement of PPS , followed by stress reducing actions including acupressure , can decrease depressive symptoms and increase psychological well-being in people with stable IHD .
-METHODS	Observer blinded randomized clinical trial over 3 months of either intervention or treatment as usual ( TAU ) .
-METHODS	Intention to treat .
-METHODS	Two hundred and thirteen participants with IHD were included : 106 to active treatment and 107 to TAU .
-METHODS	Drop-out : 20 and 12 , respectively .
-METHODS	The active intervention included self-measurement of PPS twice daily followed by acupressure as mandatory action , aiming at a reduction in PPS .
-METHODS	Primary endpoint : change in depressive symptoms as measured by Major depression inventory ( MDI ) .
-METHODS	Other endpoints : changes in PPS , Well-being ( WHO-5 ) and mental and physical QOL ( SF-36 ) .
-RESULTS	At 3 months PPS decreased 28 % , to 58 , in active and 11 % , to 72 , in TAU , p < 0.001 .
-RESULTS	MDI decreased 22 % , to 6.5 , in active group vs. 12 % , to 8.3 in TAU , p = 0.040 .
-RESULTS	WHO-5 increased to 71.0 and 64.8 , active group and TAU , p = 0.015 .
-RESULTS	SF-36 mental score sum increased to 55.3 and 53.3 , active and TAU , p = 0.08 .
-CONCLUSIONS	PPS measurements followed by acupressure reduce PPS , depressive symptoms and increase QOL in patients with stable IHD .
-BACKGROUND	ClinicalTrials.gov NCT01513824 .
-
-###25869569
-OBJECTIVE	To investigate the postoperative analgesic effects of preemptive dexketoprofen trometamol in dogs subjected to ovariohysterectomy ( OHE ) .
-METHODS	Seventeen adult bitches of various breeds were used in this study .
-METHODS	The dogs were randomly allocated into of two groups .
-METHODS	Subjects in the dexketoprofen trometamol ( DEX ) group ( n = 10 ) , received intravenous ( i.v. ) dexketoprofen trometamol , 1 mg/kg , 15 minutes before premedication , while those assigned to the control ( C ) group ( n = 7 ) were given no analgesics prior to premedication .
-METHODS	Pain level was assessed by two researchers before the administration of anaesthesia ( 15 minutes before start ) and 0 , 1 , 2 , 4 and 6 hours after surgery .
-METHODS	A modified University of Melbourne Pain Scale ( UMPS ) was used to evaluate pain in both groups .
-RESULTS	Serum cortisol level changed from 0 to 1 h and from 0 to 1 to 4 h were compared between the groups ; the increase in the C group was statistically significant .
-RESULTS	The modified UMPS was applied to both groups at baseline and postoperative 1 , 2 , 4 and 6 h.
-RESULTS	According to this test , the values for DEX were significantly lower than controls at 4 and 6 h ( p < 0.001 ) .
-CONCLUSIONS	Stable vital signs with unchanged biochemical parameters on dexketoprofen administration are a promising finding .
-CONCLUSIONS	The clinical advantage shown by the pain scale difference and the low serum cortisol levels should qualify dexketoprofen for preemptive pain management in dogs ( Tab .
-CONCLUSIONS	5 , Fig. 2 , Ref .
-CONCLUSIONS	30 ) .
-
-###24337625
-OBJECTIVE	This prospective study aims to explore the benefit of cytokine-induced killer cell ( CIK ) treatment in hepatocellular carcinoma patients , which has not yet been thoroughly studied before .
-METHODS	From January 2004 to May 2009 , 132 patients who were initially diagnosed with hepatocellular carcinoma of Barcelona Clinic Liver Cancer ( BCLC ) stage A , B or C , Child-Pugh scores of A or B and without prior treatment were enrolled in the study .
-METHODS	Patients were randomly assigned to either arm 1 ( n = 66 ) to receive CIK treatment plus standard treatment , or arm 2 ( n = 66 ) to receive standard treatment only .
-METHODS	The primary end point was overall survival ( OS ) and the secondary endpoint was progression-free survival as evaluated by Kaplan-Meier analyses and treatment hazard ratios with the Cox proportional hazards model .
-RESULTS	The 1-year ( OS : 74.2 % vs. 50.0 % , 95 % CI : 63.6-84 .8 % vs. 37.8-62 .2 , p = 0.002 ) , 2-year ( OS : 53.0 % vs. 30.3 % , 95 % CI : 40.8-65 .2 % vs. 19.1-41 .5 % , p = 0.002 ) , 3-year ( OS : 42.4 % vs. 24.2 % , 95 % CI : 30.4-54 .4 % vs. 13.8-34 .6 % , p = 0.005 ) and median overall and progression-free survivals of arm 1 patients were significantly higher than those of arm 2 .
-RESULTS	Therefore , in patients who are not suitable for surgery , significant benefit is obtained from CIK treatment .
-RESULTS	The main adverse effects of CIK included fever , allergy and headache pain .
-CONCLUSIONS	Hepatocellular carcinoma patients who were not suitable for surgery demonstrate prolonged overall and progression-free survival from CIK treatment .
-
-###24884731
-BACKGROUND	The risk of brain swelling after dural opening is high in patients with midline shift undergoing supratentorial tumor surgery .
-BACKGROUND	Brain swelling may result in increased intracranial pressure , impeded tumor exposure , and adverse outcomes .
-BACKGROUND	Mannitol is recommended as a first-line dehydration treatment to reduce brain edema and enable brain relaxation during neurosurgery .
-BACKGROUND	Research has indicated that mannitol enhanced brain relaxation in patients undergoing supratentorial tumor surgery ; however , these results need further confirmation , and the optimal mannitol dose has not yet been established .
-BACKGROUND	We propose to examine whether different doses of 20 % mannitol improve brain relaxation in a dose-dependent manner when administered at the time of incision .
-BACKGROUND	We will examine patients with preexisting mass effects and midline shift undergoing elective supratentorial brain tumor surgery .
-METHODS	This is a single-center , randomized controlled , parallel group trial that will be carried out at Beijing Tiantan Hospital , Capital Medical University .
-METHODS	Randomization will be achieved using a computer-generated table .
-METHODS	The study will include 220 patients undergoing supratentorial tumor surgery whose preoperative computed tomography/magnetic resonance imaging results indicate a brain midline shift .
-METHODS	Patients in group A , group B , and group C will receive dehydration treatment at incision with 20 % mannitol solutions of 0.7 , 1.0 , and 1.4 g/kg , respectively , at a rate of 600 mL/h .
-METHODS	The patients in the control group will not receive mannitol .
-METHODS	The primary outcome is an improvement in intraoperative brain relaxation and dura tension after dehydration with mannitol .
-METHODS	Secondary outcomes are postoperative outcomes and the incidence of mannitol side effects .
-CONCLUSIONS	The aim of this study is to determine the optimal dose of 20 % mannitol for intraoperative infusion .
-CONCLUSIONS	We will examine brain relaxation and outcome in patients undergoing supratentorial tumor surgery .
-CONCLUSIONS	If our results are positive , the study will indicate the optimal dose of mannitol to improve brain relaxation and avoid side effects during brain tumor surgery .
-BACKGROUND	The study is registered with the registry website http://www.chictr.org with the registration number ChiCTRTRC13003984 ( 17 December 2013 ) .
-
-###25281416
-OBJECTIVE	Laquinimod is an oral therapeutic agent under investigation for the treatment of Crohn 's disease ( CD ) , Huntington 's disease , lupus nephritis and multiple sclerosis .
-OBJECTIVE	This dose escalation study evaluated the safety and efficacy of laquinimod as induction therapy in patients with active moderate-severe CD .
-METHODS	Multicentre , double-blind , sequential-cohort , randomised controlled trial with laquinimod doses of 0.5 , 1 , 1.5 or 2mg/day or placebo ( n = 45 per cohort randomised in a 2:1 ratio ) for 8weeks with 4-week follow-up .
-METHODS	Stable concomittant therapies and prior use of anti-tumour necrosis factor agents were permitted .
-METHODS	Comprehensive safety assessments were performed and efficacy analyses included the proportions of patients in clinical remission ( CD Activity Index ( CDAI ) < 150 and no treatment failure ( TF ) ) , and with a clinical response ( 70 or 100 point CDAI reduction from baseline or remission and no TF ) .
-RESULTS	117 patients received laquinimod and 63 patients received placebo .
-RESULTS	The overall incidence of adverse events ( AEs ) in the laquinimod group was similar to the pooled placebo group ( 86.2 % -96.7 % vs 82.5 % ) and most AEs were mild to moderate in severity .
-RESULTS	Treatment with laquinimod 0.5 mg showed consistent effects on remission ( 48.3 % ( CI 31 % to 66 % ) vs 15.9 % ( CI 9 % to 27 % ) ) , response 100 ( 55.2 % ( CI 37 % to 71 % ) vs 31.7 % ( CI 22 % to 44 % ) ) and response 70 ( 62.1 % ( CI 44 % to 77 % ) vs 34.9 % ( CI 24 % to 47 % ) ) versus placebo .
-RESULTS	Laquinimod 1.0 mg showed less benefit ( 26.7 % remission ( CI 14 % to 44 % ) and 53.3 % response 70 ( CI 36 % to 70 % ) ) , and no effect was noted on remission/response at higher doses .
-CONCLUSIONS	Laquinimod was safe and well tolerated , and the effects on remission and response of the 0.5 mg dose suggest a treatment benefit in patients with CD .
-BACKGROUND	NCT00737932 .
-
-###24781568
-BACKGROUND	Deep general anesthesia has been associated with increased mortality in 5 observational studies .
-BACKGROUND	The association may be causal or an epiphenomenon due to increased anesthetic sensitivity in high-risk patients .
-BACKGROUND	We conducted a pilot study to assess the feasibility of performing a definitive randomized controlled trial .
-BACKGROUND	The aims of the study were to determine whether anesthetic depth targeting in a high-risk group was feasible and to document anesthetic doses and arterial blood pressures associated with `` deep '' and `` light '' general anesthesia .
-METHODS	ASA physical status III and IV patients , aged 60 years , having surgery lasting 2 hours , with expected hospital stay 2 days , and receiving general anesthesia were randomly allocated to a Bispectral Index ( BIS ) or spectral entropy ( SE ) target of 35 ( `` low '' group ) or 50 ( `` high '' group ) .
-METHODS	The primary end point was mean BIS or SE .
-METHODS	Secondary end points were postanesthesia care unit length of stay and pain scores , quality of recovery score , hospital length of stay , postoperative complications , and death .
-METHODS	A composite end point of postoperative complications ( pneumonia , myocardial infarction , stroke , pulmonary embolism , heart failure , and death ) was determined at 1 year .
-RESULTS	One hundred twenty-five patients were recruited .
-RESULTS	The mean of the median BIS/SE values for each patient during the maintenance phase of anesthesia in the low and high groups was significantly different : 39 vs 48 ( mean difference 8 [ 95 % confidence interval { CI95 } , 6 to 10 ] , P < 0.001 ) .
-RESULTS	There was also a significant difference in mean volatile anesthetic administration ( minimum alveolar concentration ) : 0.98 vs 0.64 ( mean difference -0.35 [ CI95 , -0.44 to -0.26 ] , P < 0.001 ) and target propofol concentrations : 4.0 vs 3.1 g/mL ( mean difference -0.8 [ CI95 , -1.2 to -0.3 ] , P = 0.004 ) .
-RESULTS	Intraoperative mean arterial blood pressures were similar ( 85 vs 87 mm Hg ; mean difference 2 [ CI95 , -2 to 6 ] , P = 0.86 ) , and there were no differences in short-term recovery characteristics or hospital length of stay .
-RESULTS	There was a significant difference in the incidence of wound infection at 30 days ( 13 % vs 3 % ; risk difference -10 % [ CI95 , -21 to -0.1 ] , P = 0.04 ) .
-RESULTS	At 1 year , the composite rates of complications in the low and high groups were 28 % and 17 % ( risk difference -11 [ CI95 , -25 to 4 ] , P = 0.15 ) and mortality rates were 12 % and 9 % , respectively ( risk difference -2 [ CI95 , -14 to 9 ] , P = 0.70 ) .
-CONCLUSIONS	This pilot study demonstrated that depth of anesthesia targeting with BIS or SE was achievable in a high-risk population with adequate separation of processed electroencephalogram monitor targets .
-CONCLUSIONS	The expected incidence of postoperative complications and mortality occurred .
-CONCLUSIONS	We conclude that a large , multicenter , randomized controlled trial is feasible .
-
-###24783988
-BACKGROUND	Daily oral triple therapy is effective at halting HIV disease progression , but can have toxic effects and is costly .
-BACKGROUND	We investigated whether dual therapy with lopinavir and ritonavir plus lamivudine is non-inferior to standard triple therapy .
-METHODS	The GARDEL study ( Global AntiRetroviral Design Encompassing Lopinavir/r and Lamivudine vs LPV/r based standard therapy ) is a 48 week , phase 3 , randomised , controlled , open-label , non-inferiority trial in antiretroviral-therapy-naive adults ( age 18 years ) with documented HIV-1 RNA viral load of at least 1000 copies per mL .
-METHODS	The study was done at 19 centres in six countries .
-METHODS	Patients were randomly assigned ( 1:1 ) to dual therapy or triple therapy by sealed envelopes , in blocks of four , stratified by baseline viral load ( < 100,000 vs 100,000 copies per mL ) .
-METHODS	Dual therapy consisted of lopinavir 400 mg and ritonavir 100 mg plus lamivudine 150 mg , both twice daily .
-METHODS	Triple therapy consisted of lopinavir 400 mg and ritonavir 100 mg twice daily and lamivudine or emtricitabine plus another nucleoside reverse transcriptase inhibitor ( NRTI ) in fixed-dose combination .
-METHODS	Efficacy was analysed in all participants who received at least one dose of study drug .
-METHODS	The primary endpoint was virological response rate , defined as the proportion of patients with HIV RNA less than 50 copies per mL at 48 weeks .
-METHODS	Dual therapy was classed as non-inferior to triple therapy if the lower bound of the 95 % CI for the difference between groups was no lower than -12 % .
-METHODS	Patients and investigators were unmasked to treatment allocation .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01237444 .
-RESULTS	Between Dec 10 , 2010 , and May 15 , 2012 , 217 patients were randomly assigned to the dual-therapy group and 209 to the triple-therapy group .
-RESULTS	198 patients in the dual-therapy group and 175 in the triple-therapy group completed 48 weeks of treatment .
-RESULTS	At week 48 , 189 patients ( 883 % ) in the dual-therapy group and 169 ( 837 % ) in the triple-therapy group had viral response ( difference 46 % , 95 % CI -22 to 118 ; p = 0171 ) .
-RESULTS	Patients with baseline viral load of at least 100,000 copies per mL showed similar results ( 872 % vs 779 % , respectively ; difference 93 % , 95 % CI -28 to 215 ; p = 0145 ) .
-RESULTS	Toxicity-related or tolerability-related discontinuations were more common in the triple-therapy group ( n = 10 [ 49 % ] ) than in the dual-therapy group ( n = 1 [ 04 % ] ; difference 45 % , 95 % CI -81 to -09 ; p = 0011 ) .
-RESULTS	65 adverse events in the dual-therapy group and 88 in the triple-therapy group were possibly or probably drug related ( p = 0007 ) .
-RESULTS	Two serious adverse events occurred , both in the dual-therapy arm , one of which ( a case of gastritis ) was reported as possibly or probably related to drug treatment .
-CONCLUSIONS	Dual therapy with lopinavir and ritonavir plus lamivudine regimen warrants further clinical research and consideration as a potential therapeutic option for antiretroviral-therapy-naive patients .
-BACKGROUND	Fundacin Husped and AbbVie .
-
-###25605862
-OBJECTIVE	This phase III randomized trial ( ClinicalTrials.gov identifier : NCT00337103 ) compared eribulin with capecitabine in patients with locally advanced or metastatic breast cancer ( MBC ) .
-METHODS	Women with MBC who had received prior anthracycline - and taxane-based therapy were randomly assigned to receive eribulin or capecitabine as their first - , second - , or third-line chemotherapy for advanced/metastatic disease .
-METHODS	Stratification factors were human epidermal growth factor receptor-2 ( HER2 ) status and geographic region .
-METHODS	Coprimary end points were overall survival ( OS ) and progression-free survival ( PFS ) .
-RESULTS	Median OS times for eribulin ( n = 554 ) and capecitabine ( n = 548 ) were 15.9 and 14.5 months , respectively ( hazard ratio [ HR ] , 0.88 ; 95 % CI , 0.77 to 1.00 ; P = .056 ) .
-RESULTS	Median PFS times for eribulin and capecitabine were 4.1 and 4.2 months , respectively ( HR , 1.08 ; 95 % CI , 0.93 to 1.25 ; P = .30 ) .
-RESULTS	Objective response rates were 11.0 % for eribulin and 11.5 % for capecitabine .
-RESULTS	Global health status and overall quality-of-life scores over time were similar in the treatment arms .
-RESULTS	Both treatments had manageable safety profiles consistent with their known adverse effects ; most adverse events were grade 1 or 2 .
-CONCLUSIONS	In this phase III study , eribulin was not shown to be superior to capecitabine with regard to OS or PFS .
-
-###25661407
-OBJECTIVE	To examine the association between familial high lipoprotein ( a ) , or Lp ( a ) , concentrations and endothelial function in children participating in the Special Turku Coronary Risk Factor Intervention Project study .
-METHODS	Seven-month-old children ( n = 1062 ) with their families were randomized to a risk intervention group or to a control group .
-METHODS	The intervention group received individualized dietary counseling to reduce the total cholesterol concentration .
-METHODS	Children 's Lp ( a ) and lipid values were measured repeatedly .
-METHODS	At age 11 years , children were recruited to an ultrasound study of the flow-mediated dilation ( FMD ) of the brachial artery .
-METHODS	The association between relative peak FMD and Lp ( a ) concentration was examined in 198 control and 193 intervention group children by linear regression analyses adjusted for sex , total cholesterol concentration , and basal artery diameter .
-METHODS	The analyses were made in both the control and intervention groups and in the familial risk children who had a parent with Lp ( a ) concentration greater than 250 mg/l .
-RESULTS	Lp ( a ) concentrations were similar at age 11 years in the intervention and control groups .
-RESULTS	In all control children , FMD ( % ) associated inversely with Lp ( a ) concentration : ( [ % / 1000 mg/L ] = -3.74 , 95 % CI [ -6.43 , -1.45 ] ; P = .007 ) and in 68 familial risk children ( = -4.92 , 95 % CI [ -8.18 , -1.66 ] ; P = .0037 ) .
-RESULTS	In the intervention group the associations were lacking ( P > .5 ) , and FMD in the children with high Lp ( a ) concentrations ( > 500 mg/L , n = 12 ) had no attenuation ( P = .027 ) .
-CONCLUSIONS	Familial high Lp ( a ) concentration is associated with attenuated endothelial function .
-CONCLUSIONS	This association may be mitigated by an early lifestyle intervention .
-BACKGROUND	ClinicalTrials.gov : NCT00223600 .
-
-###24820633
-OBJECTIVE	Differences in patient tolerance , acceptance , and satisfaction of esophagogastroduodenoscopy ( EGD ) between transnasal ( TN ) and peroral ( PO ) routes using a 5-mm video endoscope .
-METHODS	A total of 220 enrolled patients were assigned randomly to two groups undergoing EGD-110 patients each for TN and PO .
-METHODS	The successful rate , procedure time , and adverse events were recorded .
-METHODS	After the procedure , patients answered a validated questionnaire of tolerance , acceptance , and satisfaction .
-RESULTS	There were 6 failures ( 5.7 % ) of nasal intubation and two nasal bleeding ( 2 % ) among 105 TN-EGD procedures .
-RESULTS	All PO patients ( n = 102 ) completed EGD successfully without adverse event .
-RESULTS	Compared to PO , the procedure of TN achieved lower successful rate ( 94 % vs. 100 % , p = 0.01 ) , was complicated with epistaxis ( 2 % vs. 0 % ) and took longer ( mean SD 19.9 6.1 min vs. 16.8 6.4 min , p = 0.0001 ) .
-RESULTS	The patients undergoing TN-EGD indicated less discomfort during passing pharynx ( scores of 2.1 2.0 vs. 3.1 2.6 , p = 0.011 ) but more pain during inserting scope ( scores of 2.2 1.6 vs. 1.5 1.8 , p = 0.0001 ) .
-RESULTS	Eventually , there were no significant differences between TN and PO regarding the overall procedure discomfort ( scores of 10.7 6.6 vs. 11.1 7.8 scores , p = 0.9 ) , satisfaction ( scores of 41.2 4.2 vs. 41.3 4.6 , p = 0.91 ) , and acceptability ( 87.8 % vs. 94.2 % , p = 0.91 ) .
-CONCLUSIONS	PO intubation seems an excellent alternative method when using a 5-mm ultrathin endoscopy because it achieves comparable patient tolerance , acceptance , and satisfaction as TN intubation , takes less time and causes lower intubation failure and epistaxis .
-
-###25064487
-OBJECTIVE	The purpose was to evaluate the acceptability and feasibility of hand massage therapy in the intensive care unit ( ICU ) .
-BACKGROUND	Clinical guidelines suggest the use of non-pharmacological interventions for pain management in ICU adults .
-BACKGROUND	The results presented are secondary to a pilot RCT evaluating the preliminary effectiveness of hand massage on pain after cardiac surgery .
-METHODS	A qualitative descriptive design was used .
-METHODS	Acceptability was evaluated using individual interviews with participants in both groups i.e. , experimental and control ( n = 40 ) .
-METHODS	Feasibility was examined using field notes and video recordings .
-RESULTS	While participants receiving the massage perceived it as appropriate , the control group suggested different dosages of the treatment and body areas targeted .
-RESULTS	Results also suggest that barriers ( e.g. noise , numerous clinical activities ) need to be overcome .
-CONCLUSIONS	Increasing staff acceptance , reducing the rest period , involving families , and repeating the treatment are avenues to consider .
-CONCLUSIONS	Building evidence for non-pharmacological pain management in the critical care setting is necessary .
-
-###25615691
-OBJECTIVE	The purpose of this study was to investigate whether a shorter language sample elicited with fewer pictures ( i.e. , 7 ) would yield a percent grammatical utterances ( PGU ) score similar to that computed from a longer language sample elicited with 15 pictures for 3-year-old children .
-METHODS	Language samples were elicited by asking forty 3-year-old children with varying language skills to talk about pictures in response to prompts .
-METHODS	PGU scores were computed for each of two 7-picture sets and for the full set of 15 pictures .
-RESULTS	PGU scores for the two 7-picture sets did not differ significantly from , and were highly correlated with , PGU scores for the full set and with each other .
-RESULTS	Agreement for making pass-fail decisions between each 7-picture set and the full set and between the two 7-picture sets ranged from 80 % to 100 % .
-CONCLUSIONS	The current study suggests that the PGU measure is robust enough that it can be computed on the basis of 7 , at least in 3-year-old children whose language samples were elicited using similar procedures .
-
-###25007694
-BACKGROUND	This was a prospective randomized single-blinded clinical trial comparing the glottic views obtained during direct laryngoscopy between the ` sniffing the morning air ' position and simple head extension .
-METHODS	A sample of 378 patients , aged 18 to 75 years old with ASA physical status I or II , scheduled for elective surgery under general anesthesia with endotracheal intubation , were randomized into 2 groups .
-METHODS	Group A used the sniffing position during the first laryngoscopy while Group B was put in simple head extension position .
-METHODS	Positions were then interchanged for the second laryngoscopy .
-METHODS	Sniffing position was obtained by placing a 7 cm height non-compressible cushion under the patient 's head .
-METHODS	In simple head extension , patient 's head was placed flat .
-METHODS	Glottic visualization was assessed based on the Cormack & Lehane scale .
-METHODS	Intubation was performed after second laryngoscopy and success rate of first attempt intubation was compared .
-RESULTS	The distribution of patients with different Cormack & Lehane scores between the two intubation positions were significantly different ( p < 0.001 ) .
-RESULTS	Changing over to the ` Sniffing position ' resulted in improvement of the Cormack & Lehane scores in 109 ( 57.7 % ) patients , no change in 75 ( 39.7 % ) or worsening in 5 ( 4.8 % ) patients .
-RESULTS	Successful intubation at first attempt was better ( p < 0.05 ) with Group A : 156 ( 83.5 % ) while Group B : 121 ( 64.0 % ) .
-CONCLUSIONS	Sniffing position provided better glottic visualization score and increased the successful rate of intubation as compared to simple head extension .
-
-###24732447
-BACKGROUND	Many risks of death in childhood bacterial meningitis are well-identified , but factors influencing survival time have received less attention .
-BACKGROUND	Better understanding of this issue could help explain why adjuvant medications have performed unevenly in different trials .
-METHODS	In a post hoc analysis of prospectively collected data from a large bacterial meningitis treatment trial in Luanda , Angola , we compared time to death after initiation of antimicrobial treatment among 206 children with etiology and other patient characteristics .
-METHODS	The risks of dying very quickly ( 0-4 hours ) , quickly ( 4-8 hours ) or after longer periods were analyzed by logistic regression .
-RESULTS	Median time to death was 18.5 hours , half the time in Streptococcus pneumoniae ( 11.8 hours ) compared with Haemophilus influenzae ( 26.8 hours ) meningitis .
-RESULTS	Of all deaths caused by pneumococcal or H.influenzae meningitis , 42 % versus 16 % , respectively , occurred within the first 8 hours .
-RESULTS	In addition , patients who succumbed within 8 hours , unlike those dying later , had a short disease history , shock , hypoglycemia and poor cerebrospinal fluid white cell response .
-CONCLUSIONS	Time to death in Angola is so short that hardly anything , except perhaps modern intensive care , is likely to improve outcome in a patient with meningitis , especially the pneumococcal disease .
-
-###24342252
-BACKGROUND	Quadrivalent human papillomavirus ( HPV ) vaccine , for protection against sexually transmitted HPV infection , is licensed for females and males 9-26 years on a 3-dose schedule ( 0 , 2 , and 6 months ; Standard schedule ) .
-BACKGROUND	Vaccine uptake has been low and catch-up vaccination of older adolescents using an alternate dosing schedule may increase coverage .
-BACKGROUND	This study tested the non-inferiority of the immunogenicity of an alternate dosing schedule ( 0 , 2 , 12 months ) among college age males .
-METHODS	220 18-25 year old males were randomly assigned to Standard or Alternate schedules .
-METHODS	Blood samples were drawn immediately before Dose 1 and 2-6 weeks after Dose 3 and analyzed for antibody titers using a Luminex immunoassay .
-METHODS	A value < 1.5 for the upper 95 % confidence interval ( CI ) bound of the Standard to Alternate schedule geometric mean titer ( GMT ) ratio was deemed non-inferior .
-RESULTS	Participants averaged 21.3 years old ; 19.1 % were non-white ; completion rate was 93 % .
-RESULTS	The anti-HPV titers for the Alternate schedule group were non-inferior to those of Standard schedule group for all four HPV vaccine virus types .
-RESULTS	Our results also demonstrated superiority of the Alternate schedule group for all four HPV vaccine virus types .
-CONCLUSIONS	A delayed third dose at 12 months is immunologically non-inferior and superior for four HPV virus types .
-CONCLUSIONS	Using an alternate dosing schedule offers more flexibility to receive the 3-dose HPV vaccine and may result in higher vaccination rates among college-age males .
-
-###25968121
-BACKGROUND	Various hospital accreditation and quality assurance entities in the United States have approved and endorsed performance measures promoting alcohol brief intervention ( BI ) for hospitalized individuals who screen positive for unhealthy alcohol use , the spectrum of use ranging from hazardous use to alcohol use disorders .
-BACKGROUND	These performance measures have been controversial due to the limited and equivocal evidence for the efficacy of BI among hospitalized individuals .
-BACKGROUND	The few BI trials conducted with hospital inpatients vary widely in methodological quality .
-BACKGROUND	While the majority of these studies indicate limited to no effects of BI in this population , none have been designed to account for the most pervasive methodological issue in BI studies presumed to drive study findings towards the null : assessment reactivity ( AR ) .
-METHODS	This is a three-arm , single-site , randomized controlled trial of BI for hospitalized patients at a large academic medical center affiliated with the U.S. Department of Veterans Affairs who use alcohol at hazardous levels but do not have an alcohol use disorder .
-METHODS	Participants are randomized to one of three study conditions .
-METHODS	Study Arm 1 receives a three-part alcohol BI .
-METHODS	Study Arm 2 receives attention control .
-METHODS	To account for potential AR , Study Arm 3 receives AC with limited assessment .
-METHODS	Primary outcomes will include the number of standard drinks/week and binge drinking episodes reported in the 30-day period prior to a final measurement visit obtained 6 months after hospital discharge .
-METHODS	Additional outcomes will include readiness to change drinking behavior and number of adverse consequences of alcohol use .
-METHODS	To assess differences in primary outcomes across the three arms , we will use mixed-effects regression models that account for a patient 's repeated measures over the timepoints and clustering within medical units .
-METHODS	Intervention implementation will be assessed by : a ) review of intervention audio recordings to characterize barriers to intervention fidelity ; and b ) feasibility of participant recruitment , enrollment , and follow-up .
-CONCLUSIONS	The results of this methodologically rigorous trial will provide greater justification for or against the use of BI performance measures in the inpatient setting and inform organizational responses to BI-related hospital accreditation and performance measures .
-BACKGROUND	NCT01602172 .
-
-###25096689
-OBJECTIVE	Although brief intervention is effective for reducing problem alcohol use , few data exist on its effectiveness for reducing problem drug use , a common issue in disadvantaged populations seeking care in safety-net medical settings ( hospitals and community health clinics serving low-income patients with limited or no insurance ) .
-OBJECTIVE	To determine whether brief intervention improves drug use outcomes compared with enhanced care as usual .
-METHODS	A randomized clinical trial with blinded assessments at baseline and at 3 , 6 , 9 , and 12 months conducted in 7 safety-net primary care clinics in Washington State .
-METHODS	Of 1621 eligible patients reporting any problem drug use in the past 90 days , 868 consented and were randomized between April 2009 and September 2012 .
-METHODS	Follow-up participation was more than 87 % at all points .
-METHODS	Participants received a single brief intervention using motivational interviewing , a handout and list of substance abuse resources , and an attempted 10-minute telephone booster within 2 weeks ( n = 435 ) or enhanced care as usual , which included a handout and list of substance abuse resources ( n = 433 ) .
-METHODS	The primary outcomes were self-reported days of problem drug use in the past 30 days and Addiction Severity Index-Lite ( ASI ) Drug Use composite score .
-METHODS	Secondary outcomes were admission to substance abuse treatment ; ASI composite scores for medical , psychiatric , social , and legal domains ; emergency department and inpatient hospital admissions , arrests , mortality , and human immunodeficiency virus risk behavior .
-RESULTS	Mean days used of the most common problem drug at baseline were 14.40 ( SD , 11.29 ) ( brief intervention ) and 13.25 ( SD , 10.69 ) ( enhanced care as usual ) ; at 3 months postintervention , means were 11.87 ( SD , 12.13 ) ( brief intervention ) and 9.84 ( SD , 10.64 ) ( enhanced care as usual ) and not significantly different ( difference in differences , = 0.89 [ 95 % CI , -0.49 to 2.26 ] ) .
-RESULTS	Mean ASI Drug Use composite score at baseline was 0.11 ( SD , 0.10 ) ( brief intervention ) and 0.11 ( SD , 0.10 ) ( enhanced care as usual ) and at 3 months was 0.10 ( SD , 0.09 ) ( brief intervention ) and 0.09 ( SD , 0.09 ) ( enhanced care as usual ) and not significantly different ( difference in differences , = 0.008 [ 95 % CI , -0.006 to 0.021 ] ) .
-RESULTS	During the 12 months following intervention , no significant treatment differences were found for either variable .
-RESULTS	No significant differences were found for secondary outcomes .
-CONCLUSIONS	A one-time brief intervention with attempted telephone booster had no effect on drug use in patients seen in safety-net primary care settings .
-CONCLUSIONS	This finding suggests a need for caution in promoting widespread adoption of this intervention for drug use in primary care .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00877331 .
-
-###25842456
-OBJECTIVE	An equivalence randomized controlled trial within the subject was organized to evaluate the clinical long-term success of a new 2-step etch & rinse adhesive and a new nano-filled ormocer .
-METHODS	50 subjects , 21 males and 29 females aged between 21 and 65 , were randomized to receive 150 restorations , 100 with the new restorative material , 50 with the composite as control , placed in non-carious cervical lesions with the same bonding system .
-METHODS	The main outcome measure was the cause of failure at 8 years .
-METHODS	Randomization was number table-generated , with allocation concealment by opaque sequentially numbered sealed and stapled envelopes .
-METHODS	Subjects , examiner , and analyst were blinded to group assignment .
-METHODS	Two interim analyses were performed .
-METHODS	Data were analyzed by ANOVA and Cox test ( P < 0.05 ) .
-RESULTS	After 8 years , 40 subjects and 120 teeth were included in the analysis of the primary outcome .
-RESULTS	There were eight failures in the experimental group and four failures in the control group .
-RESULTS	The cumulative loss rate was 7 % for both restorative materials , with the annual failure lower than 1 % , without any statistically significant difference .
-RESULTS	There were two key elements of failure : the presence of sclerotic dentin and the relationship between lesion and gingival margin .
-
-###25172769
-BACKGROUND	The therapeutic and economic benefits of continuous positive airway pressure ( CPAP ) for moderate to severe obstructive sleep apnoea ( OSA ) syndrome have been established in middle-aged people ; however , the benefits in older people are unknown .
-BACKGROUND	This trial was designed to address this evidence gap .
-METHODS	This 12-month , multicentre , randomised trial enrolled patients across 14 National Health Service sleep centres in the UK .
-METHODS	Consecutive patients aged 65 years or older with newly diagnosed OSA syndrome were eligible to join the trial .
-METHODS	Patients were randomly assigned ( 1:1 ) into parallel groups to receive either CPAP with best supportive care ( BSC ) or BSC alone for 12 months .
-METHODS	Randomisation was done by the Medical Research Council Clinical Trials Unit with computer-generated randomisation .
-METHODS	The main investigator at each centre was masked to the trial randomisation .
-METHODS	Coprimary endpoints were Epworth sleepiness score ( ESS ) at 3 months and cost-effectiveness over the 12-month trial period .
-METHODS	Secondary outcomes were subjective sleepiness at 12 months , plus objective sleepiness , quality of life , mood , functionality , nocturia , mobility , accidents , cognitive function , and cardiovascular risk factors and events at 3 months and 12 months .
-METHODS	The analysis was by intention to treat .
-METHODS	This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN90464927 .
-RESULTS	Between Feb 24 , 2010 , and May 30 , 2012 , 278 patients were randomly assigned to the trial , of whom 231 ( 83 % ) completed the trial .
-RESULTS	140 patients were allocated to and received CPAP plus BSC and 138 were allocated to and received BSC only .
-RESULTS	CPAP reduced ESS by 21 points ( 95 % CI -30 to -13 ; p < 00001 ) at 3 months for 124 ( 89 % ) of 140 patients compared with 124 ( 90 % ) of 138 patients given BSC , and by 20 points ( -28 to -12 ; p < 00001 ) at 12 months for 116 patients compared with 122 patients given BSC .
-RESULTS	The effect was greater in patients with higher CPAP usage or higher baseline ESS .
-RESULTS	Quality-adjusted life-years were similar between the groups ( treatment effect 001 ( 95 % CI -003 to 004 ; p = 0787 ) and health-care costs were marginally reduced with CPAP ( -35 , -390 to 321 ; p = 0847 ) .
-RESULTS	CPAP improved objective sleepiness ( p = 0024 ) , mobility ( p = 0029 ) , total cholesterol ( p = 0048 ) , and LDL cholesterol ( p = 0042 ) at 3 months , but these were not sustained at 12 months .
-RESULTS	Measures of mood , functionality , nocturia , accidents , cognitive function , and cardiovascular events remained unchanged .
-RESULTS	Systolic blood pressure fell in the BSC group .
-RESULTS	37 serious adverse events occurred in the CPAP group , and 22 in BSC group ; all were independently classified as being unrelated to the trial and no significant harm was attributed to CPAP use .
-CONCLUSIONS	In older people with OSA syndrome , CPAP reduces sleepiness and is marginally more cost effective over 12 months than is BSC alone .
-CONCLUSIONS	On the basis of these results , we recommend that CPAP treatment should be offered routinely to older patients with OSA syndrome .
-BACKGROUND	National Institute of Health Research ( NIHR ) Health Technology Assessment , NIHR Respiratory Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College London .
-
-###24599650
-BACKGROUND	During lower limb lengthening , poor bone regeneration is a devastating complication .
-BACKGROUND	Several local or systemic applications have been used to promote osteogenesis , and biologic stimulations are gaining attention , but their utility has not been proven in this setting .
-OBJECTIVE	In patients undergoing bilateral tibial lengthening , we compared those receiving an osteotomy site injection of autologous bone marrow aspirate concentrate ( BMAC ) plus platelet-rich plasma ( PRP ) with those not receiving such an injection in terms of external fixator index ( time in external fixation divided by amount of lengthening ) , full weightbearing index ( time until a patient was permitted to do full weightbearing divided by amount of lengthening ) , four cortical healing indexes ( time until each cortical union divided by amount of lengthening ) , and callus shape and type .
-METHODS	Twenty-two patients ( 44 tibias ) undergoing bilateral tibial lengthening enrolled in this randomized trial .
-METHODS	Two patients were excluded , one due to insufficient radiographic evaluation and one who was lost to followup , leaving 20 patients ( 40 segments ) for inclusion .
-METHODS	Ten patients ( 20 segments ) received BMAC combined with PRP injection ( treatment group ) and 10 patients ( 20 segments ) received no injection ( control group ) .
-METHODS	All patients underwent stature lengthening for familial short stature with the lengthening over nail technique .
-METHODS	Autologous BMAC combined with PRP was injected at the tibial osteotomy site at the end of the index surgery .
-METHODS	Mean distraction rates were similar between groups ( 0.75 mm/day in the treatment group versus 0.72 mm/day in the control group ; p = 0.24 ) .
-METHODS	Full weightbearing was permitted when we observed radiographic evidence of healing at two cortices ; this assessment was made by the surgeon who was blinded to the treatment each patient received .
-METHODS	Minimum followup was 24 months ( mean , 28 months ; range , 24-34 months ) .
-RESULTS	There was no difference in mean external fixator index between groups .
-RESULTS	However , mean cortical healing indexes ( anterior/posterior/medial / lateral ) were 1.14 / 0.81 / 0.96 / 0.88 months/cm in the treatment group and 1.47 / 1.26 / 1.42 / 1.22 months/cm in the control group ( all p < 0.001 ) , showing faster healing in the treatment group at each cortex .
-RESULTS	Full weightbearing was permitted earlier in the treatment group than in the control group ( index : 0.99 months/cm and 1.38 months/cm , respectively , p < 0.001 ) .
-RESULTS	Callus shape and type were not different between groups .
-CONCLUSIONS	Autologous BMAC combined with PRP injection at the osteotomy site helped improve bone healing in distraction osteogenesis of the tibia , although the effect size was small .
-METHODS	Level I , therapeutic study .
-METHODS	See Instructions for Authors for a complete description of levels of evidence .
-
-###24354834
-OBJECTIVE	We determined the effectiveness of primary care-based , and pre - and postnatal interventions to increase breastfeeding .
-METHODS	We conducted 2 trials at obstetrics and gynecology practices in the Bronx , New York , from 2008 to 2011 .
-METHODS	The Provider Approaches to Improved Rates of Infant Nutrition & Growth Study ( PAIRINGS ) had 2 arms : usual care versus pre - and postnatal visits with a lactation consultant ( LC ) and electronically prompted guidance from prenatal care providers ( EP ) .
-METHODS	The Best Infant Nutrition for Good Outcomes ( BINGO ) study had 4 arms : usual care , LC alone , EP alone , or LC+EP .
-RESULTS	In BINGO at 3 months , high intensity was greater for the LC+EP ( odds ratio [ OR ] = 2.72 ; 95 % confidence interval [ CI ] = 1.08 , 6.84 ) and LC ( OR = 3.22 ; 95 % CI = 1.14 , 9.09 ) groups versus usual care , but not for the EP group alone .
-RESULTS	In PAIRINGS at 3 months , intervention rates exceeded usual care ( OR = 2.86 ; 95 % CI = 1.21 , 6.76 ) ; the number needed to treat to prevent 1 dyad from nonexclusive breastfeeding at 3 months was 10.3 ( 95 % CI = 5.6 , 50.7 ) .
-CONCLUSIONS	LCs integrated into routine care alone and combined with EP guidance from prenatal care providers increased breastfeeding intensity at 3 months postpartum .
-
-###24822268
-BACKGROUND	Recurrent aphthous stomatitis ( RAS ) is the most common oral mucosal disease .
-BACKGROUND	However , the available therapies for RAS only relieve symptoms and do not provide a cure .
-OBJECTIVE	This study assessed the response to treatment with levamisole and low-dose prednisolone drug combination in patients with RAS .
-METHODS	Fifty RAS subjects were enrolled in the single-blind randomized placebo-controlled trial .
-METHODS	Study medications were administered thrice daily for 3 consecutive days/week for 3 consecutive weeks .
-METHODS	Patients in Group 1 received placebo , Group 2 received levamisole ( 50 mg ) and Group 3 received levamisole ( 50 mg ) and low-dose prednisolone ( 5 mg ) .
-METHODS	Patients were followed up for 60 days after treatment .
-METHODS	Response to treatment was assessed using the following clinical parameters : pain due to ulcers , number of ulcers/episode , size of ulcers , duration of ulcers , and frequency of ulcers ( episodes/month ) .
-METHODS	MannWhitney U-test .
-RESULTS	A statistically significant improvement was noted in all parameters except for the size of ulcers in patients treated with levamisole alone and with combination of levamisole and low-dose prednisolone .
-RESULTS	There was no statistically significant improvement in the placebo group .
-RESULTS	Both active groups had significantly better improvement when compared to placebo group , while there was no significant difference between the two active groups .
-CONCLUSIONS	Levamisole alone and combination of levamisole and low-dose prednisolone are effective modes of therapy for RAS .
-
-###25187049
-OBJECTIVE	Substance use disorder ( SUD ) is a major health issue , especially among military veterans .
-OBJECTIVE	We previously reported the effects of auricular acupuncture and the relaxation response ( RR ) on reducing craving and anxiety following 10-week interventions among veterans who were in recovery from SUDs .
-OBJECTIVE	Our current analysis examines effects following each intervention session and RR daily practice .
-METHODS	We conducted a three-arm randomized controlled trial on residents of a homeless veteran rehabilitation program .
-METHODS	Sixty-Seven enroled participants were randomly assigned to acupuncture ( n = 23 ) , RR ( n = 23 ) , or usual care ( n = 21 ) .
-METHODS	Participants in the two intervention groups rated their degree of craving for substance on a scale of 1-10 and anxiety levels on a scale of 1-4 ( total score 20-80 ) before and after each intervention session .
-METHODS	Mixed effects regression models were used for analysis .
-RESULTS	Craving and anxiety levels decreased significantly following one session of acupuncture ( -1.04 , p = .0001 ; -8.83 , p < .0001 ) or RR intervention ( -.43 , p = .02 ; -4.64 , p = .03 ) .
-RESULTS	The level of craving continued to drop with additional intervention sessions ( regression coefficient b = -.10 , p = .01 , and b = -.10 , p = .02 for acupuncture and RR groups , respectively ) .
-RESULTS	Number of daily practice days of RR-eliciting techniques is also associated with reduction in craving ratings ( b = -.02 , p = .008 ) .
-CONCLUSIONS	Findings demonstrate the value of attending regular acupuncture and RR-eliciting intervention sessions , as well as the daily practice of RR-eliciting techniques .
-CONCLUSIONS	Substance addiction is a complex disease and effective treatment remains a challenge .
-CONCLUSIONS	Our study findings add to the scientific evidence of these two non-pharmaceutical approaches for SUD .
-
-###25018116
-BACKGROUND	An estimated 100 million people have symptomatic dengue infection every year .
-BACKGROUND	This is the first report of a phase 3 vaccine efficacy trial of a candidate dengue vaccine .
-BACKGROUND	We aimed to assess the efficacy of the CYD dengue vaccine against symptomatic , virologically confirmed dengue in children .
-METHODS	We did an observer-masked , randomised controlled , multicentre , phase 3 trial in five countries in the Asia-Pacific region .
-METHODS	Between June 3 , and Dec 1 , 2011 , healthy children aged 2-14 years were randomly assigned ( 2:1 ) , by computer-generated permuted blocks of six with an interactive voice or web response system , to receive three injections of a recombinant , live , attenuated , tetravalent dengue vaccine ( CYD-TDV ) , or placebo , at months 0 , 6 , and 12 .
-METHODS	Randomisation was stratified by age and site .
-METHODS	Participants were followed up until month 25 .
-METHODS	Trial staff responsible for the preparation and administration of injections were unmasked to group allocation , but were not included in the follow-up of the participants ; allocation was concealed from the study sponsor , investigators , and parents and guardians .
-METHODS	Our primary objective was to assess protective efficacy against symptomatic , virologically confirmed dengue , irrespective of disease severity or serotype , that took place more than 28 days after the third injection .
-METHODS	The primary endpoint was for the lower bound of the 95 % CI of vaccine efficacy to be greater than 25 % .
-METHODS	Analysis was by intention to treat and per procotol .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT01373281 .
-RESULTS	We randomly assigned 10,275 children to receive either vaccine ( n = 6851 ) or placebo ( n = 3424 ) , of whom 6710 ( 98 % ) and 3350 ( 98 % ) , respectively , were included in the primary analysis .
-RESULTS	250 cases of virologically confirmed dengue took place more than 28 days after the third injection ( 117 [ 47 % ] in the vaccine group and 133 [ 53 % ] in the control group ) .
-RESULTS	The primary endpoint was achieved with 565 % ( 95 % CI 438-664 ) efficacy .
-RESULTS	We recorded 647 serious adverse events ( 402 [ 62 % ] in the vaccine group and 245 [ 38 % ] in the control group ) .
-RESULTS	54 ( 1 % ) children in the vaccine group and 33 ( 1 % ) of those in the control group had serious adverse events that happened within 28 days of vaccination .
-RESULTS	Serious adverse events were consistent with medical disorders in this age group and were mainly infections and injuries .
-CONCLUSIONS	Our findings show that dengue vaccine is efficacious when given as three injections at months 0 , 6 , and 12 to children aged 2-14 years in endemic areas in Asia , and has a good safety profile .
-CONCLUSIONS	Vaccination could reduce the incidence of symptomatic infection and hospital admission and has the potential to provide an important public health benefit .
-BACKGROUND	Sanofi Pasteur .
-
-###25128052
-OBJECTIVE	This study aimed 1 ) to quantify the strength of patient preferences for different aspects of early assisted discharge in The Netherlands for patients who were admitted with a chronic obstructive pulmonary disease exacerbation and 2 ) to illustrate the benefits of latent class modeling of discrete choice data .
-OBJECTIVE	This technique is rarely used in health economics .
-METHODS	Respondents made multiple choices between hospital treatment as usual ( 7 days ) and two combinations of hospital admission ( 3 days ) followed by treatment at home .
-METHODS	The latter was described by a set of attributes .
-METHODS	Hospital treatment was constant across choice sets .
-METHODS	Respondents were patients with chronic obstructive pulmonary disease in a randomized controlled trial investigating the cost-effectiveness of early assisted discharge and their informal caregivers .
-METHODS	The data were analyzed using mixed logit , generalized multinomial logit , and latent-class conditional logit regression .
-METHODS	These methods allow for heterogeneous preferences across groups , but in different ways .
-RESULTS	Twenty-five percent of the respondents opted for hospital treatment regardless of the description of the early assisted discharge program , and 46 % never opted for the hospital .
-RESULTS	The best model contained four latent classes of respondents , defined by different preferences for the hospital and caregiver burden .
-RESULTS	Preferences for other attributes were constant across classes .
-RESULTS	Attributes with the strongest effect on choices were the burden on informal caregivers and co-payments .
-RESULTS	Except for the number of visits , all attributes had a significant effect on choices in the expected direction .
-CONCLUSIONS	Considerable segments of respondents had fixed preferences for either treatment option .
-CONCLUSIONS	Applying latent class analysis was essential in quantifying preferences for attributes of early assisted discharge .
-
-###25500307
-BACKGROUND	Polio eradication remains a challenge in Pakistan and the causes for the failure to eradicate poliomyelitis are complex .
-BACKGROUND	Undernutrition and micronutrient deficiencies , especially zinc deficiency , are major public health problems in Pakistan and could potentially affect the response to enteric vaccines , including oral poliovirus vaccine ( OPV ) .
-OBJECTIVE	To assess the impact of zinc supplementation among infants on immune response to oral poliovirus vaccine ( OPV ) .
-METHODS	A double-blind , randomized placebo-controlled trial was conducted in newborns ( aged 0-14 days ) .
-METHODS	Subjects were assigned to either receive 10mg of zinc or placebo supplementation daily for 18 weeks .
-METHODS	Both groups received OPV doses at birth , at 6 weeks , 10 weeks and 14 weeks .
-METHODS	Data was collected on prior immunization status , diarrheal episodes , breastfeeding practices and anthropometric measurements at recruitment and at 6 and 18 weeks .
-METHODS	Blood samples were similarly collected to determine the antibody response to OPV and for micronutrient analysis .
-METHODS	Logistic regression was used to determine the relationship between seroconversion and zinc status .
-RESULTS	Overall , 404 subjects were recruited .
-RESULTS	At recruitment , seropositivity was already high for poliovirus ( PV ) serotype 1 ( zinc : 91.1 % ; control : 90.5 % ) and PV2 ( 90.0 % ; 92.7 % ) , with lower estimates for PV3 ( 70.0 % ; 64.8 % ) .
-RESULTS	By week 18 , the proportion of subjects with measured zinc levels in the normal range ( i.e. 60 g/dL ) was significantly greater in the intervention group compared to the control group ( 71.9 % ; 27.4 % ; p < 0.001 ) .
-RESULTS	No significant difference in seroconversion was demonstrated between the groups for PV1 , PV2 , or PV3 .
-CONCLUSIONS	There was no effect of zinc supplementation on OPV immunogenicity .
-CONCLUSIONS	These conclusions were confirmed when restricting the analysis to those with measured higher zinc levels .
-
-###24469140
-OBJECTIVE	To evaluate the efficacy and safety of tacrolimus mouth rinse on the treatment of erosive and ulcerative oral lichen planus ( OLP ) .
-METHODS	A randomized single-blind open trial of tacrolimus mouth rinse with dexamethasone as control was designed .
-METHODS	The VAS and REU scoring system was utilized to compare the signs and symptoms .
-METHODS	The scores and therapeutic effects were analyzed with SPSS 17.0 software package .
-RESULTS	There was no significant difference in effective rate between the treatment group and control group ( X ( 2 ) = 0.295,0.413 , P > 0.01 ) at 4-week and 12-week after treatment .
-RESULTS	There was significant difference in REU scores between the 2 groups ( P < 0.01 ) 4 weeks after treatment .
-CONCLUSIONS	Tacrolimus mouth rinse effects quickly and is worthy of application in the treatment of erosive and ulcerative OLP .
-
-###24360934
-OBJECTIVE	This double-blind sham-controlled crossover study investigated the interactions between primary sensory and motor cortex after stroke and their response to Theta Burst Stimulation ( TBS ) .
-METHODS	Thirteen chronic subcortical stroke patients with upper limb impairment performed standardised dexterity training primed with ipsilesional M1 intermittent TBS ( iTBSiM1 ) , contralesional M1 continuous TBS ( cTBScM1 ) or sham TBS .
-METHODS	The effects on sensorimotor integration , corticomotor excitability , sensation and grip-lift kinetics were examined .
-RESULTS	After iTBSiM1 , improvements in paretic grip-lift performance were accompanied by an immediate facilitation of ipsilesional M1 excitability and a subsequent increase in ipsilesional short latency afferent inhibition ( SAI ) during training .
-RESULTS	Precision grip-lift performance improved after cTBScM1 and training , alongside increased ipsilesional M1 excitability with no effect on ipsilesional SAI .
-RESULTS	There were no effects on sensory performance .
-CONCLUSIONS	Primary motor cortex iTBS not only modulates M1 corticospinal excitability but also increases M1 receptiveness to sensory input .
-CONCLUSIONS	Priming with iTBSiM1 may enhance ipsilesional sensorimotor integration and facilitate better quality sensorimotor training after subcortical stroke .
-
-###24820281
-OBJECTIVE	To evaluate the analgesic effect of pregabalin combined with intrathecal sufentanil infusion for the treatment of breakthrough pain in patients with bone metastases .
-METHODS	A total of 60 breakthrough pain patients with bone metastases were randomly divided to 3 groups : group A ( pregabalin combined with intrathecal sufentanil infusion group , n = 20 ) , group B ( placebo combined with intrathecal sufentanil infusion group , n = 20 ) and group C ( oral morphine sulfate controlled-release tablet group , n = 20 ) .
-METHODS	The differences in visual analogue scale ( VAS ) between background pain and breakthrough pain , the seizure frequency of breakthrough pain , general satisfaction and side effects of the 3 groups were observed .
-RESULTS	The seizure frequency and VAS of breakthrough pain in group A decreased significantly after the treatment ( P < 0.05 ) and the general satisfaction was the best among the the 3 groups ( P < 0.05 ) , with less nausea and vomiting , constipation , drowsiness and fewer other side effects .
-CONCLUSIONS	Pregabalin combined with intrathecal sufentanil infusion can effectively relieve breakthrough pain in patients with bone metastases .
-
-###24863949
-OBJECTIVE	Durability of good glycaemic control ( HbA1c ) is of importance as it can be the foundation for delaying diabetic complications .
-OBJECTIVE	It has been hypothesized that early initiation of treatment with the combination of oral anti-diabetes agents with complementary mechanisms of action can increase the durability of glycaemic control compared with metformin monotherapy followed by a stepwise addition of oral agents .
-OBJECTIVE	Dipeptidyl peptidase-4 inhibitors are good candidates for early use as they are efficacious in combination with metformin , show weight neutrality and a low risk of hypoglycaemia .
-OBJECTIVE	We aimed to test the hypothesis that early combined treatment of metformin and vildagliptin slows - cell deterioration as measured by HbA1c .
-METHODS	Approximately 2000 people with Type 2 diabetes mellitus who were drug-naive or who were treated with metformin for less than 1 month , and who have HbA1c of 48-58 mmol/mol ( 6.5-7 .5 % ) , will be randomized in a 1:1 ratio in VERIFY , a 5-year multinational , double-blind , parallel-group study designed to compare early initiation of a vildagliptin-metformin combination with standard-of-care initiation of metformin monotherapy , followed by the stepwise addition of vildagliptin when glycaemia deteriorates .
-METHODS	Further deterioration will be treated with insulin .
-METHODS	The primary analysis for treatment failure will be from a Cox proportional hazard regression model and the durability of glycaemic control will be evaluated by assessing treatment failure rate and the rate of loss in glycaemic control over time as co-primary endpoints .
-CONCLUSIONS	VERIFY is the first study to investigate the long-term clinical benefits of early combination treatment vs. the standard-of-care metformin monotherapy with a second agent added by threshold criteria .
-
-###25192393
-OBJECTIVE	To determine the effects of participation in a 2-year community-based dance class on disease severity and functional mobility in people with Parkinson disease ( PD ) .
-METHODS	Randomized controlled trial .
-METHODS	Dance classes took place in a community-based location .
-METHODS	Outcome measures were collected in a university laboratory .
-METHODS	Ten individuals with PD were randomly assigned to the Argentine tango ( AT ) group ( n = 5 [ 4 men ] ; mean agestandard deviation , 69.66.6 years ) or the control group ( n = 5 [ 4 men ] ; mean agestandard deviation , 6611.0 years ) .
-METHODS	The AT group participated in a community-based AT class for 1 hour twice weekly for 2 years .
-METHODS	Control group participants were given no prescribed exercise .
-METHODS	Blinded assessments occurred at baseline and 12 and 24 months .
-METHODS	Movement Disorder Society-Unified Parkinson Disease Rating Scale ( MDS-UPDRS ) III , Mini-Balance Evaluation Systems Test ( Mini-BESTest ) , gait velocity ( forward and backward ) , Timed Up and Go and dual-task Timed Up and Go , Six-Minute Walk Test ( 6MWT ) , MDS-UPDRS II , MDS-UPDRS I , and Freezing of Gait Questionnaire .
-RESULTS	There were no differences between groups at baseline .
-RESULTS	A significant group-by-time interaction ( F [ 2,8 ] = 17.59 ; p < 0.0001 ) was noted for the MDS-UPDRS III , with the AT group having lower scores at 12 and 24 months than the controls .
-RESULTS	Significant interactions were also noted for the Mini-BESTest , MDS-UPDRS II and I , and 6MWT .
-CONCLUSIONS	This is believed to be one of the longest-duration studies to examine the effects of exercise on PD .
-CONCLUSIONS	Participation in community-based dance classes over 2 years was associated with improvements in motor and nonmotor symptom severity , performance on activities of daily living , and balance in a small group of people with PD .
-CONCLUSIONS	This is noteworthy given the progressive nature of PD and the fact that the control group declined on some outcome measures over 2 years .
-
-###25865864
-BACKGROUND	Falls are the most frequent adverse events that are reported in hospitals .
-BACKGROUND	We examined the effectiveness of individualised falls-prevention education for patients , supported by training and feedback for staff , delivered as a ward-level programme .
-METHODS	Eight rehabilitation units in general hospitals in Australia participated in this stepped-wedge , cluster-randomised study , undertaken during a 50 week period .
-METHODS	Units were randomly assigned to intervention or control groups by use of computer-generated , random allocation sequences .
-METHODS	We included patients admitted to the unit during the study with a Mini-Mental State Examination ( MMSE ) score of more than 23/30 to receive individualised education that was based on principles of changes in health behaviour from a trained health professional , in addition to usual care .
-METHODS	We provided information about patients ' goals , feedback about the ward environment , and perceived barriers to engagement in falls-prevention strategies to staff who were trained to support the uptake of strategies by patients .
-METHODS	The coprimary outcome measures were patient rate of falls per 1000 patient-days and the proportion of patients who were fallers .
-METHODS	All analyses were by intention to treat .
-METHODS	This trial is registered with the Australian New Zealand Clinical Trials registry , number ACTRN12612000877886 ) .
-RESULTS	Between Jan 13 , and Dec 27 , 2013 , 3606 patients were admitted to the eight units ( n = 1983 control period ; n = 1623 intervention period ) .
-RESULTS	There were fewer falls ( n = 196 , 780/1000 patient-days vs n = 380 , 1378/1000 patient-days , adjusted rate ratio 060 [ robust 95 % CI 042-094 ] , p = 0003 ) , injurious falls ( n = 66 , 263/1000 patient-days vs 131 , 475/1000 patient-days , 065 [ robust 95 % CI 042-088 ] , p = 0006 ) , and fallers ( n = 136 [ 838 % ] vs n = 248 [ 1251 % ] adjusted odds ratio 055 [ robust 95 % CI 038 to 081 ] , p = 0003 ) in the intervention compared with the control group .
-RESULTS	There was no significant difference in length of stay ( intervention median 11 days [ IQR 7-19 ] , control 10 days [ 6-18 ] ) .
-CONCLUSIONS	Individualised patient education programmes combined with training and feedback to staff added to usual care reduces the rates of falls and injurious falls in older patients in rehabilitation hospital-units .
-BACKGROUND	State Health Research Advisory Council , Department of Health , Government of Western Australia .
-
-###24923372
-BACKGROUND	Development of endotracheal intubation to avoid deleterious effect on hemodynamic responses occurring during laryngoscopy and intubation compelled researchers to venture into alternative measures of airway management with subtle hemodynamic responses .
-BACKGROUND	This study was carried out to compare the conditions for laryngeal mask airways LMA insertion with widely used intravenous induction agents , thiopentone sodium and propofol , and also to compare the undesired responses occurring during LMA insertion with them .
-METHODS	The study was prospective , randomized , and double blind .
-METHODS	All patients selected were randomly allocated into two groups : Group 1 ( propofol ) and group II ( thiopentone ) .
-METHODS	Preinduction heart rate and blood pressure were recorded .
-METHODS	Sixty healthy adult patients of either sex belonging to age group of 20-60 years and ASA grade I or II , to undergo surgery less than 1 h , were selected for the study-Patients were randomly allocated in two groups , 30 in each group .
-METHODS	Premedication with midazolam 0.04 mg/kg and fentanyl 2 mg/kg done in both groups .
-METHODS	Thereafter , group 1 was induced with 2 mg/kg of propofol and group 2 with 5 mg/kg of thiopentone sodium .
-RESULTS	The study revealed that , ease of insertion of LMA , was statistically significantly greater in group 1 when compared with group 2 ( P 0.05 ) .
-RESULTS	The time required for successful insertion of LMA was lesser in group 1 patients ( 53.8 7.77 s ) than in group 2 patients ( 84.7 16.54 s ) ( P 0.001 ) .
-CONCLUSIONS	Severity of undesired responses were more in group 2 , as incremental boluses of respective induction agents were required in 20 % patients in thiopentone group compared to only 6 % patients in propofol group and 13 % of patients in thiopentone group required rescue succinylcholine .
-
-###25380994
-BACKGROUND	South Africa has a high and rising prevalence of hypertension .
-BACKGROUND	Many affected individuals are not using medication , and few have controlled blood pressure .
-BACKGROUND	Until recently , primary care clinics focused on maternal and child health and management of acute conditions , but new government initiatives have shifted the focus to chronic diseases , including HIV/AIDS and hypertension .
-METHODS	The Nkateko trial will test the effectiveness of clinic-based lay health workers ( LHWs ) in supporting hypertension management .
-METHODS	It is a pragmatic , cluster randomised controlled trial based in the Agincourt subdistrict of northeast South Africa , and it is underpinned by long-term health and demographic surveillance .
-METHODS	Eight primary care facilities , with their catchment communities , are randomised to usual care or the addition of LHWs focused on chronic care .
-METHODS	All clinics ( intervention and control ) will be provided with a clerk to collect information on clinic attendees and will match them to preexisting surveillance records .
-METHODS	Intervention clinics will have LHWs working alongside nursing staff and focusing on health care for people with chronic conditions , particularly hypertension .
-METHODS	The LHWs will be supported by an implementation manager , who will work with clinic staff to develop the most effective role for the LHWs .
-METHODS	Control clinics will continue to provide usual care .
-METHODS	The primary outcome will be the change between two population surveys conducted before and after the intervention in the proportion of the population with uncontrolled hypertension and a risk profile indicating at least moderate risk of cardiovascular disease .
-METHODS	A process evaluation will be based on a realist approach using patient exit interviews , clinic observations and interviews with health professionals , LHWs and patients to document the intervention and its implementation .
-CONCLUSIONS	There are challenges in the design of this trial .
-CONCLUSIONS	Assessing change through population surveys may reduce measurable effects ; however , we feel this is appropriate because we aim to attract those who currently do not use clinics , and we hope to improve care for clinic users .
-CONCLUSIONS	Clinics were randomised at an open meeting because we were concerned that a remote process of randomisation would not be trusted by the community .
-CONCLUSIONS	We are constantly working to achieve an effective balance between the intervention and process evaluations .
-BACKGROUND	ISRCTN12128227 ( registered 5 March 2014 ) .
-
-###25893283
-OBJECTIVE	Little evidence exists on whether effects of an early obesity intervention are sustainable .
-OBJECTIVE	To assess the sustainability of effects of a home-based early intervention on children 's body mass index ( BMI ) and BMI z score at 3 years after intervention .
-METHODS	A longitudinal follow-up study of the randomized clinical Healthy Beginnings Trial was conducted with 465 participating mothers consenting to be followed up at 3 years after intervention until their children were age 5 years .
-METHODS	This study was conducted in socially and economically disadvantaged areas of Sydney , Australia , from March 2011 to June 2014 .
-METHODS	No further intervention was carried out in this Healthy Beginnings Trial phase 2 follow-up study .
-METHODS	The original intervention in phase 1 comprised 8 home visits from community nurses delivering a staged home-based intervention , with one visit in the antenatal period and 7 visits at 1 , 3 , 5 , 9 , 12 , 18 , and 24 months after birth .
-METHODS	Primary outcomes were children 's BMI and BMI z score .
-METHODS	Secondary outcomes included dietary behaviors , quality of life , physical activity , and TV viewing time of children and their mothers .
-RESULTS	In total , 369 mothers and their children completed the follow-up study , a phase 2 completion rate of 79.4 % ( 80.9 % for the intervention group and 77.7 % for the control group ) .
-RESULTS	The differences between the intervention and control groups at age 2 years in children 's BMI and BMI z score disappeared over time .
-RESULTS	At age 2 years , the difference ( intervention minus control ) in BMI ( calculated as weight in kilograms divided by height in meters squared ) was -0.41 ( 95 % CI , -0.71 to -0.10 ; P = .009 ) , but by age 5 years it was 0.03 ( 95 % CI , -0.30 to 0.37 ) .
-RESULTS	No effects of the early intervention on dietary behaviors , quality of life , physical activity , and TV viewing time were detected at age 5 years .
-CONCLUSIONS	The significant effect of this early life home-visiting intervention on child BMI and BMI z score at age 2 years was not sustained at age 5 years without further intervention .
-CONCLUSIONS	Obesity prevention programs need to be continued or maintained during the early childhood years .
-
-###24926954
-BACKGROUND	Changes in gut motor and hormonal function contribute to the eating-inhibitory and glucose-lowering effects of protein .
-BACKGROUND	The effect of amino acids , the digestive products of protein , on gastrointestinal function , eating , and glycemia has not been investigated comprehensively .
-OBJECTIVE	We tested the hypothesis that L-tryptophan ( L-Trp ) stimulates gastrointestinal motor and hormonal functions , inhibits eating , and modulates glycemia .
-OBJECTIVE	Design , Settings , Participants , and Intervention : Ten healthy , normal-weight men were studied in randomized , double-blind fashion , each receiving a 90-minute intraduodenal infusion of L-Trp at 0.075 ( total 6.75 kcal ) or 0.15 ( total 13.5 kcal ) kcal/min or saline ( control ) .
-METHODS	Antropyloroduodenal motility , plasma ghrelin , cholecystokinin , glucagon-like peptide-1 , peptide tyrosine tyrosine , insulin , glucagon , blood glucose , and appetite perceptions were measured .
-METHODS	Food intake was quantified from a buffet meal after the infusion .
-RESULTS	Intraduodenal L-Trp suppressed antral pressures ( P < .05 ) and stimulated pyloric pressures ( P < .01 ) and markedly increased cholecystokinin and glucagon ( both P < .001 ) .
-RESULTS	Glucagon-like peptide-1 and peptide tyrosine tyrosine increased modestly ( both P < .001 ) , but there was no effect on total ghrelin .
-RESULTS	Insulin increased slightly ( P < .05 ) without affecting blood glucose .
-RESULTS	Plasma L-Trp increased substantially ( P < .001 ) .
-RESULTS	All effects were dose-related and associated with increased fullness and substantially decreased energy intake ( P < .001 ) .
-RESULTS	There was a strong inverse correlation between energy intake and plasma L-Trp ( r = -0.70 ; P < .001 ) .
-CONCLUSIONS	Low caloric intraduodenal loads of L-Trp affect gut motor and hormonal function and markedly reduce energy intake .
-CONCLUSIONS	A strong inverse correlation between energy intake and plasma L-Trp suggests that , beyond gut mechanisms , direct effects of circulating L-Trp mediate its eating-inhibitory effect .
-
-###24988292
-OBJECTIVE	To examine characteristics of ocular hypertensive subjects and potential associations with estimated cerebrospinal fluid pressure ( estCSFP ) .
-METHODS	The population-based Beijing Eye Study 2011 included 3468 individuals with a mean age of 64.69.8 years .
-METHODS	Ocular hypertension was defined as intraocular pressure ( IOP ) > 21 mmHg , normal optic nerve head appearance and normal retinal nerve fiber layer thickness .
-METHODS	IOP was corrected for its dependence on central corneal thickness ( CCT ) and corneal curvature radius .
-METHODS	Estimated CSFP was calculated as CSFP [ mmHg ] = 0.44 Body Mass Index [ kg/m2 ] +0.16 Diastolic Blood Pressure [ mmHg ] -0.18 Age [ Years ] -1.91 .
-METHODS	Estimated trans-lamina cribrosa pressure difference ( estTLCPD ) was IOP-estCSFP .
-RESULTS	EstCSFP ( 10.53.6 mmHg versus 9.03.7 mmHg ; P = 0.003 ) and estTLCPD ( 12.04.4 mmHg versus 5.43.8 mmHg ; P < 0.001 ) were higher in the ocular hypertensive group than in the normotensive group .
-RESULTS	In binary regression analysis , ocular hypertension was associated with increased estCSFP ( P = 0.03 ; odds ratio ( OR ) : 1.08 ; 95 % confidence interval ( CI ) : 1.01 , 1.17 ) after adjusting for prevalence of arterial hypertension ( P = 0.07 ; OR : 1.79 ; 95 % CI : 0.96 , 3.34 ) , retinal nerve fiber layer thickness ( P = 0.03 ; OR : 0.97 ; 95 % CI : 0.95 , 0.997 ) and blood glucose concentration ( P = 0.006 ; OR : 1.17 ; 95 % CI : 1.04 , 1.30 ) .
-CONCLUSIONS	Ocular hypertensive subjects ( with IOP correction for CCT and corneal curvature ) as compared to ocular normotensive subjects had a significantly higher estCSFP in univariate analysis and in multivariate analysis .
-CONCLUSIONS	Despite of a higher estCSFP , estTLCPD was still markedly higher in ocular hypertensive eyes than in ocular normotensive eyes .
-
-###25704725
-OBJECTIVE	Compare the effect of financial incentives on response to a cancer survivors ' postal questionnaire .
-METHODS	Prostate cancer survivors in Ireland , 1.5-18 years after diagnosis , were randomized to the ( 1 ) `` lottery '' arm [ a 1 lottery scratch card sent with the questionnaire ( n = 2,413 ) ] or ( 2 ) `` prize '' arm [ entry into a draw on return of a completed questionnaire ( n = 2,407 ) ] .
-METHODS	Impact of interventions on response overall and by survival period ( `` short term '' : < 5 years after diagnosis ; `` long term '' : 5 years after diagnosis ) was compared as was cost-effectiveness .
-RESULTS	Adjusted response rate was 54.4 % .
-RESULTS	Response was higher among younger men ( P < 0.001 ) and those with earlier stage disease ( P = 0.002 ) .
-RESULTS	A modest 2.6 % higher response rate was observed in the lottery compared with the prize arm [ multivariate relative risk ( RR ) = 1.06 ; 95 % confidence interval ( CI ) : 1.00 , 1.11 ] .
-RESULTS	When stratified by survival period , higher response in the lottery arm was only observed among long-term survivors ( multivariate RR = 1.10 ; 95 % CI : 1.02 , 1.19 ; short-term survivors : RR = 1.01 ; 95 % CI : 0.94 , 1.09 ) .
-RESULTS	Costs per completed questionnaire were 4.54 and 3.57 for the lottery and prize arms , respectively .
-RESULTS	Compared with the prize arm , cost per additional questionnaire returned in the lottery arm was 25.65 .
-CONCLUSIONS	Although more expensive , to optimize response to postal questionnaires among cancer survivors , researchers might consider inclusion of a lottery scratch card .
-
-###26349124
-OBJECTIVE	To assess a newly developed index to measure interproximal stain and evaluate the stain removal efficacy of two commercially available manual toothbrushes .
-METHODS	This was a randomized , examiner-blind , parallel-group , two-treatment clinical trial of two weeks ' duration .
-METHODS	Subjects qualified for the study if they had an average Modified Lobene Stain Index of 1.5 from two anterior teeth .
-METHODS	At baseline , subjects brushed in front of a mirror for one minute under supervision .
-METHODS	All subjects were provided with a standard 0.243 % sodium fluoride dentifrice and were randomly assigned either an Oral-B Pulsar manual brush ( OBP ) or a Colgate Whitening manual brush ( CW ) to use for two weeks .
-METHODS	Stain was reassessed after two weeks of product use .
-METHODS	Stain measurements were conducted using the Modified Lobene Stain Index and the new Interproximal Modified Lobene Stain Index , which allows for assessment of stain in hard-to-reach areas using the same area and intensity scales as the Modified Lobene Stain Index .
-RESULTS	Use of the two manual brushes resulted in statistically significant reductions in surface stain relative to baseline after two weeks of use .
-RESULTS	Median stain reductions were 78 % and 60 % for the OBP and CW , respectively , as measured by the Modified Lobene Stain Index .
-RESULTS	The mean changes in the composite scores from baseline to week two were 1.85 and 1.57 for the two treatment groups , respectively .
-RESULTS	Statistically significant reductions from baseline were also found for the intensity and extent of stain measures ( p < 0.001 ) .
-RESULTS	Similar trends were found using the new Interproximal Modified Lobene Index .
-RESULTS	Composite median stain removal percentages versus baseline were 88 % and 73 % for the OBP and CW groups , respectively ( p < 0.001 ) .
-RESULTS	For the interproximal sites , a median stain removal of 92 % was observed with the OBP brush and 83 % reduction with the CW brush .
-RESULTS	For the gingival sites , the median stain removal percentages were 83 % and 50 % , respectively For the body region , a median stain removal of 100 % was found for both treatment groups .
-RESULTS	No statistically significant differences were found between the two groups for the mean composite scores for either index .
-CONCLUSIONS	Both manual brushes showed effective stain removal , including interproximal hard-to-reach sites .
-CONCLUSIONS	The Interproximal Modified Lobene Stain Index gave clinically relevant results consistent with the traditional Modified Lobene Stain Index , while allowing assessment of interproximal regions .
-
-###25166443
-BACKGROUND	Patients undergoing both rigid and flexible cystoscopic evaluation suffer from a great deal of pain and discomfort .
-BACKGROUND	In this study , we aimed to investigate the effect of lidocaine gel anestesia on patient comfort on diagnostic rigid cystoscopy .
-METHODS	11 mL of lubricant gel applied to each patient via the external meatus in 10 s. Patients were randomized into three groups .
-METHODS	In group 1 , liquid glycerine was applied and cystoscopy was immediately performed , in group 2 lidocaine gel ( Aqua Touch : stem Tbbi Cihaz Ve Sanayi Ltd.ti , Ostim , Ankara , Trkiye ) was applied and the procedure undergone immediately and in group 3 , lidocaine gel was applied and penis was clemped for 10 minutes before the procedure .
-METHODS	VAS forms were filled to determine the discomfort and pain during cystoscopy and the first micturation after .
-RESULTS	After the evaluation between groups , VAS scores were significantly lower in Group II and III than Group I and in Group III than in Group II ( p < 0.05 ) .
-RESULTS	When post micturation VAS scores were evaluated , VAS scores were significantly lower in Group II than Group I and in Group III than in Group II ( p < 0.05 ) .
-CONCLUSIONS	The application of local anesthetic lidocaine gel in rigid cystoscopy , is a practical , safe and efficient method to improve patient comfort when applied in appropriate dose and waiting duration .
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-###25894719
-OBJECTIVE	For patients with clinically significant risk of febrile neutropenia , pegfilgrastim administration should occur the day after myelosuppressive chemotherapy ; however , a variety of factors may preclude patients from returning to the clinic the next day for pegfilgrastim administration , necessitating other strategies .
-OBJECTIVE	This study compared the pharmacokinetics and safety of pegfilgrastim administered via an on-body injector applied to the subject 's skin versus manual injection using a prefilled syringe .
-METHODS	Healthy subjects aged 18-50years were randomized 1:1 to receive a single 6-mg subcutaneous pegfilgrastim dose from an on-body injector or a prefilled syringe .
-METHODS	Blood for pharmacokinetic measurements was collected at baseline and prespecified time points after pegfilgrastim administration ; safety was assessed throughout the 6-week study .
-METHODS	Primary endpoints were maximum concentration ( C max ) and area under the concentration curve from time 0 to infinity ( AUC0-inf ) .
-METHODS	Secondary endpoints included safety , tolerability , and immunogenicity .
-RESULTS	Pegfilgrastim mean AUC0-inf values for the on-body injector ( n = 125 ) and manual injection ( n = 128 ) were 10,900 and 11,100 hng/mL , respectively ; mean C max values were 248 and 262ng/mL , respectively .
-RESULTS	The least squares geometric mean ratios were 0.97 for C max and 1.00 for AUC0-inf ; the corresponding 90 % CIs were within the prespecified range ( 0.80-1 .25 ) , indicating comparable pegfilgrastim pharmacokinetics between delivery methods .
-RESULTS	Treatment-emergent adverse events ( AEs ) were similar between groups ( injector , 86 % ; manual , 85 % ) .
-RESULTS	Injector - or syringe-related AEs were more prevalent with the injector ( 13 % ; manual , 4 % ) ; none were serious .
-RESULTS	No pegfilgrastim-neutralizing antibodies were detected .
-CONCLUSIONS	Pegfilgrastim pharmacokinetics and safety were comparable between the on-body injector and manual injection groups .
-
-###25271011
-OBJECTIVE	Although single , high doses of vitamin D effectively maintain vitamin D sufficiency in several populations , no studies have evaluated healthy adults over winter , during which vitamin D status declines .
-OBJECTIVE	This study investigated whether high-dose vitamin D3 given once to healthy adults before winter will ( 1 ) prevent the wintertime decline in vitamin D status , ( 2 ) promote vitamin D sufficiency 1 year following the dose and ( 3 ) prevent the rise of parathyroid hormone ( PTH ) concentrations .
-METHODS	In this double-blind , placebo-controlled trial , we assessed plasma 25 ( OH ) D and PTH concentrations at baseline , 5 , 90 and 365 days after drug administration in 28 healthy adults .
-METHODS	In all , > 80 % of subjects returned at each time point .
-RESULTS	At baseline , the young , healthy participants had a mean plasma 25 ( OH ) D concentration of 17.56.1 ng/ml .
-RESULTS	Only two subjects exhibited plasma 25 ( OH ) D concentrations > 30ng/ml .
-RESULTS	At 5 days , subjects randomized to vitamin D3 had a higher mean plasma 25 ( OH ) D concentration compared with the placebo group ( 39.1 vs 19.1 ng/ml , P < 0.001 ) .
-RESULTS	Plasma 25 ( OH ) D concentrations returned to baseline at 90 and 365 days in the vitamin D3 group and remained unchanged in the placebo group .
-RESULTS	PTH and calcium concentrations were unrelated to changes in 25 ( OH ) D levels and similar between groups over time .
-CONCLUSIONS	A dose of 250,000 IU of vitamin D3 given once in November resulted in a robust increase in plasma 25 ( OH ) D after 5 days , but it was unable to sustain this increase after 90 days .
-CONCLUSIONS	A larger or more frequent dosing regimen may be needed for long-term vitamin D sufficiency .
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-###25948720
-OBJECTIVE	We sought to determine the association of dietary factors and risk of cognitive decline in a population at high risk of cardiovascular disease .
-METHODS	Baseline dietary intake and measures of the Mini-Mental State Examination were recorded in 27,860 men and women who were enrolled in 2 international parallel trials of the ONTARGET ( Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial ) and TRANSCEND ( Telmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease ) studies .
-METHODS	We measured diet quality using the modified Alternative Healthy Eating Index .
-METHODS	Cox proportional hazards regression was used to determine the association between diet quality and risk of 3-point decline in Mini-Mental State Examination score , and reported as hazard ratio with 95 % confidence intervals with adjustment for covariates .
-RESULTS	During 56 months of follow-up , 4,699 cases of cognitive decline occurred .
-RESULTS	We observed lower risk of cognitive decline among those in the healthiest dietary quintile of modified Alternative Healthy Eating Index compared with lowest quintile ( hazard ratio 0.76 , 95 % confidence interval 0.66-0 .86 , Q5 vs Q1 ) .
-RESULTS	Lower risk of cognitive decline was consistent regardless of baseline cognitive level .
-CONCLUSIONS	We found that higher diet quality was associated with a reduced risk of cognitive decline .
-CONCLUSIONS	Improved diet quality represents an important potential target for reducing the global burden of cognitive decline .
-
-###24913242
-BACKGROUND	Insufficient data exist regarding postoperative thoracic epidural analgesia for morbidly obese patients undergoing open bariatric surgery .
-BACKGROUND	This study evaluated the effectiveness of morphine loading in a postoperative thoracic epidural analgesic regimen of patient-controlled epidural analgesia ( PCEA ) with levobupivacaine combined with continuously administered epidural morphine in this patient group .
-METHODS	In this prospective randomized controlled trial , 48 superobese patients ( body mass index of 50 kg/m ( 2 ) ) undergoing open bariatric surgery were randomly allocated to three groups of 16 patients each .
-METHODS	Postoperatively , all groups received a continuous epidural morphine infusion of 0.2 mg/h with 0.1 % levobupivacaine via PCEA .
-METHODS	Group A did not receive intraoperative epidural morphine loading , while groups B and C received an intraoperative 1 - and 2-mg morphine bolus , respectively .
-METHODS	Levobupivacaine consumption via PCEA ( primary outcome ) , pain scores at rest and on cough , the time to return of bowel function and ambulation , and arterial blood gas levels ( secondary outcomes ) were recorded .
-RESULTS	The increase in perioperative morphine administration ( groups B and C ) led to a significantly prolonged return to normal bowel function and delayed ambulation ( P < 0.05 to 0.01 , respectively ) , without an improvement in postoperative analgesia or a reduction in local anesthetic consumption .
-RESULTS	Although the prevalence of obstructive sleep apnea ( OSA ) was high in all groups , no respiratory depression was observed .
-CONCLUSIONS	Thoracic PCEA with 0.1 % levobupivacaine combined with continuous epidural morphine administration of 0.2 mg/h without morphine loading is an effective postoperative analgesic regimen that provides adequate pain control , early ambulation , and early return of bowel function in superobese patients , particularly those with OSA .
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-###25139178
-OBJECTIVE	Anxiety is a prominent symptom in anorexia nervosa ( AN ) , and higher pre-meal anxiety has been associated with lower caloric intake .
-OBJECTIVE	Yet , the causal relationship has not been assessed .
-OBJECTIVE	We proposed that reducing anxiety with a short acting benzodiazepine would increase caloric intake among individuals with AN .
-METHODS	In a randomized , double-blind , placebo controlled cross-over study , we administered alprazolam 0.75 mg to inpatients with AN ( n = 17 ) and assessed caloric intake in a laboratory test meal .
-METHODS	Within-subject differences in caloric intake , anxiety , and fatigue were compared between alprazolam and placebo days .
-RESULTS	Caloric intake did not differ on alprazolam versus placebo ( t ( 15 ) = 1.72 , p = .11 ) .
-RESULTS	Alprazolam did not reduce anxiety , but was associated with increased fatigue .
-CONCLUSIONS	This study was not able to evaluate the causal role of anxiety in meal intake among individuals with AN , as alprazolam did not alter anxiety symptoms .
-CONCLUSIONS	These data further suggest that the therapeutic role for short-acting benzodiazepines in AN is likely limited .
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-###24631058
-BACKGROUND	Elevating the torso in a Head Elevated Ramped Position during caesarean delivery benefits the mother by improving comfort and ventilation while reducing reflux symptoms and providing a better airway position .
-BACKGROUND	We hypothesised that using an elevation pillow for an elective caesarean delivery under combined spinal-epidural anaesthesia would not significantly increase the time to achieve a T4 block .
-METHODS	Following ethical approval and informed consent , 60 women undergoing elective caesarean delivery under combined spinal-epidural anaesthesia were randomised to one of three groups : Control - horizontal with a small pillow under the head ; Head Elevated Ramped Position - torso on an elevation pillow ; and Head Elevated Ramped Position with initial position horizontal .
-METHODS	Data collected were time to T4 , block height at 30 and 120 min , adequate block at 12 min , need for epidural supplementation , maternal comfort and airway position assessment .
-RESULTS	Time to T4 among the three groups was not significantly different ( P = 0.14 ) .
-RESULTS	However , there was a significant difference in achievement of block height of T4 at 12 min and greater need for epidural supplementation in the intervention groups compared to the control group ( P = 0.021 ) .
-RESULTS	Non-inferiority analyses of time to T4 of both head elevated ramped positions were inconclusive about inferiority relative to the control .
-RESULTS	Head Elevated Ramped Position was significantly more comfortable than control ( P = 0.007 ) .
-RESULTS	Using the level of the external auditory meatus to the sternal notch as an indicator for ease of laryngoscopy , Head Elevated Ramped Position provided a significantly better position than control ( P < 0.001 ) .
-CONCLUSIONS	Elevating the parturient undergoing elective caesarean delivery into the Head Elevated Ramped Position immediately or once the block had been established did not appear to significantly alter time to an adequate block height of T4 ; however , the need for epidural supplementation was greater in the intervention groups .
-CONCLUSIONS	Cautious use of this novel position change can provide a more comfortable experience and provide a better airway position should conversion to general anaesthesia be required .
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-###26237831
-OBJECTIVE	To observe the effect of pressing auricular points on myopia in children .
-METHODS	Myopic children aged 8-9 years were divided into two groups .
-METHODS	The Chinese herb Semen Vaccariae was used to stimulate the auricular points of CO10 , LO5 , TF4 , CO15 , CO12 , and CO13 for three treatment courses for the experimental group ( n = 39 ) , while the same therapy was not given to the control group ( n = 33 ) .
-METHODS	Binocular naked vision of the experimental group and the control group before and after the intervention was measured using a standard E visual.acuity chart .
-RESULTS	There was no difference in the binocular naked vision between the experimental group and the control group before the intervention .
-RESULTS	In contrast , there was significant improvement in binocular naked vision in the experimental group after the intervention compared with the control group ( P < 0.05 ) .
-CONCLUSIONS	When combined with external medical application , non-invasive auricular therapy could improve the function of myopia in children .
-CONCLUSIONS	Auricular pressing was well received by the children .
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-###25782323
-OBJECTIVE	To study compliance to treatment and effectiveness of therapy in patients with axial spondyloarthritis ( ax-SpA ) in different observational regimes .
-METHODS	168 patients without TNF - therapy and BASDAI 4 were randomized into 3 groups .
-METHODS	96 of them were observed in a traditional manner , 26 visited a rheumatologist every 12 weeks , and 46 were counseled by phone once in 4 weeks .
-METHODS	In all these cases , rheumatologists collected data on the activity of the disease ( BASDAI , ASDAS , PASS , etc. ) and the effectiveness of therapy .
-RESULTS	BASDAI in group 1 was 5.32 3.2 initially and 5.17 2.16 one year after onset of the study , ASDAS 3.45 2.1 and 3.1 1.1 respectively ( p > 0.05 ) .
-RESULTS	In group 2 , BASDAI values were 5.21 3.0 and 4.77 2.2 ; ASDAS 3.42 2.9 and 2.79 2.6 respectively .
-RESULTS	In group 3 , BASDAI values were 5.32 3.2 and 3.17 2.12 ; ASDAS 3.44 3.1 and 2.6 1.8 ; p < 0.05 for the differences between initial and subsequent values in groups 2 and 3 and final values for all groups .
-RESULTS	Positive PASS was reached in 15 patients ( 57.69 % , n = 26 ) of group 3 , in 4 ones ( 20 % , n = 20 ) of group 2 , and in 0 ( 0 % ) patients of group 1 .
-RESULTS	Five ( 19.23 % ) , 15 ( 75 % ) and 93 ( 96.87 % ) patients in groups 1 , 2 and 3 respectively wilfully ceased to take NSAID .
-RESULTS	96 ( 100 % ) , 19 ( 95 % ) and 3 ( 11.5 % ) patients of these groups stated that they needed hospitalization .
-CONCLUSIONS	Telephone monitoring of ax-SpA activity once in every 4 weeks revealed a better compliance with the treatment and results of therapy than active observation every 12 weeks or arbitrary monitoring .
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-###24569001
-OBJECTIVE	To test different forms of private insurance coverage as mediators for racial disparities in onset , persistent level , and acceleration of functional limitations among Medicare age-eligible Americans .
-METHODS	Data come from 7 waves of the Health and Retirement Study ( 1996-2008 ) .
-METHODS	Onset and progression latent growth models were used to estimate racial differences in onset , level , and growth of functional limitations among a sample of 5,755 people aged 65 and older in 1996 .
-METHODS	Employer-provided insurance , spousal insurance , and market insurance were next added to the model to test how differences in private insurance mediated the racial gap in physical limitations .
-RESULTS	In baseline models , African Americans had larger persistent level of limitations over time .
-RESULTS	Although employer-provided , spousal provided , and market insurances were directly associated with lower persistent levels of limitation , only differences in market insurance accounted for the racial disparities in persistent level of limitations .
-CONCLUSIONS	Results suggest private insurance is important for reducing functional limitations , but market insurance is an important mediator of the persistently larger level of limitations observed among African Americans .
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-###24943961
-BACKGROUND	Ensuring adherence to treatment and retention is important in clinical trials , particularly in remote areas and minority groups .
-BACKGROUND	We describe a novel approach to improve adherence , retention and clinical review rates of Indigenous children .
-METHODS	This descriptive study was nested within a placebo-controlled , randomised trial ( RCT ) on weekly azithromycin ( or placebo ) for 3-weeks .
-METHODS	Indigenous children aged 24-months hospitalised with acute bronchiolitis were recruited from two tertiary hospitals in northern Australia ( Darwin and Townsville ) .
-METHODS	Using mobile phones embedded within a culturally-sensitive approach and framework , we report our strategies used and results obtained .
-METHODS	Our main outcome measure was rates of adherence to medications , retention in the RCT and self-presentation ( with child ) to clinic for a clinical review on day-21 .
-RESULTS	Of 301 eligible children , 76 ( 21 % ) families declined participation and 39 ( 13 % ) did not have access to a mobile phone .
-RESULTS	186 Indigenous children were randomised and received dose one under supervision in hospital .
-RESULTS	Subsequently , 182 ( 99 % ) children received dose two ( day-7 ) , 169 ( 93 % ) dose three ( day-14 ) and 180 ( 97 % ) attended their clinical review ( day-21 ) .
-RESULTS	A median of 2 calls ( IQR 1-3 ) were needed to verify adherence .
-RESULTS	Importantly , over 97 % of children remained in the RCT until their clinical endpoint at day-21 .
-CONCLUSIONS	In our setting , the use of mobile phones within an Indigenous-appropriate framework has been an effective strategy to support a clinical trial involving Australian Indigenous children in urban and remote Australia .
-CONCLUSIONS	Further research is required to explore other applications of this approach , including the impact on clinical outcomes .
-BACKGROUND	ACTRN12608000150347 ( RCT component ) .
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-###25332071
-OBJECTIVE	CD5 + B cells have been conceptualized as a possible surrogate for Breg cells .
-OBJECTIVE	The aim of the present study was to determine the utility of CD5 + B cells as biomarkers in antineutrophil cytoplasmic antibody-associated vasculitis ( AAV ) .
-METHODS	The absolute and relative numbers ( percentages ) of CD5 + B cells ( explanatory variables ) were measured longitudinally during 18 months in 197 patients randomized to receive either rituximab ( RTX ) or cyclophosphamide ( CYC ) followed by azathioprine ( AZA ) for the treatment of AAV ( Rituximab in ANCA-Associated Vasculitis [ RAVE ] trial ) .
-METHODS	Outcome variables included disease activity ( status of active disease versus complete remission ) , responsiveness to induction therapy , disease relapse , disease severity , and , in RTX-treated patients , relapse-free survival according to the percentage of CD5 + B cells detected upon B cell repopulation .
-RESULTS	CD5 + B cell numbers were comparable between the treatment groups at baseline .
-RESULTS	After an initial decline , absolute CD5 + B cell numbers progressively increased in patients in the RTX treatment arm , but remained low in CYC/AZA-treated patients .
-RESULTS	In both groups , the percentage of CD5 + B cells increased during remission induction and slowly declined thereafter .
-RESULTS	During relapse , the percentage of CD5 + B cells correlated inversely with disease activity in RTX-treated patients , but not in patients who received CYC/AZA .
-RESULTS	No significant association was observed between the numbers of CD5 + B cells and induction treatment failure or disease severity .
-RESULTS	The dynamics of the CD5 + B cell compartment did not anticipate disease relapse .
-RESULTS	Following B cell repopulation , the percentage of CD5 + B cells was not predictive of time to flare in RTX-treated patients .
-CONCLUSIONS	The percentage of peripheral CD5 + B cells might reflect disease activity in RTX-treated patients .
-CONCLUSIONS	However , sole staining for CD5 as a putative surrogate marker for Breg cells did not identify a subpopulation of B cells with clear potential for meaningful clinical use .
-CONCLUSIONS	Adequate phenotyping of Breg cells is required to further explore the value of these cells as biomarkers in AAV .
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-###25333730
-BACKGROUND	Hazelnut allergy in adults is often birch pollen related , whereas in children , non-pollen-related hazelnut allergy is more frequent .
-OBJECTIVE	To compare the differences in hazelnut allergy between children and adults with regard to severity , aetiology and diagnostic value of routinely available data .
-METHODS	Adults ( n = 120 ) who underwent a double-blind placebo-controlled food challenge ( DBPCFC ) for hazelnut were selected and compared to 151 hazelnut-challenged children from a previous study .
-METHODS	Univariate and multivariate logistic regression analyses were performed to build a prediction model .
-METHODS	The area under the curve ( AUC ) of the ROC curve was determined for level of hazelnut-specific IgE , skin prick test ( SPT ) and the prediction model .
-RESULTS	Hazelnut allergy was confirmed by DBPCFC in 95/120 ( 79 % ) adults , 77 % had only subjective and 23 % objective symptoms , whereas in children , 63 % had objective symptoms to hazelnut .
-RESULTS	Within the group of children , the frequency of severe hazelnut allergy was higher in younger than in older children .
-RESULTS	A concomitant birch pollen allergy was more common in adults ( 82 % ) than in children ( 39 % ) with a hazelnut allergy .
-RESULTS	A detailed history with allergic symptoms to previous ingestion of hazelnut had the highest diagnostic value in adults , while in children , SPT to hazelnut extract showed the highest level of discrimination between clinical reactivity and tolerance to hazelnut .
-CONCLUSIONS	Hazelnut allergy differs between children and adults with respect to frequency of severity , aetiology and relevance of diagnostic parameters .
-CONCLUSIONS	Therefore , age has to be taken into account in the diagnostic work-up of a hazelnut allergy .
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-###25028542
-OBJECTIVE	Assisted living ( AL ) residents are at risk for cognitive and functional declines that eventually reduce their ability to care for themselves , thereby triggering nursing home placement .
-OBJECTIVE	In developing a method to slow this decline , the efficacy of Reasoning Exercises in Assisted Living ( REAL ) , a cognitive training intervention that teaches everyday reasoning and problem-solving skills to AL residents , was tested .
-METHODS	At thirteen randomized Midwestern facilities , AL residents whose Mini Mental State Examination scores ranged from 19-29 either were trained in REAL or a vitamin education attention control program or received no treatment at all .
-METHODS	For 3 weeks , treated groups received personal training in their respective programs .
-RESULTS	Scores on the Every Day Problems Test for Cognitively Challenged Elders ( EPCCE ) and on the Direct Assessment of Functional Status ( DAFS ) showed significant increases only for the REAL group .
-RESULTS	For EPCCE , change from baseline immediately postintervention was +3.10 ( P < 0.01 ) , and there was significant retention at the 3-month follow-up ( d = 2.71 ; P < 0.01 ) .
-RESULTS	For DAFS , change from baseline immediately postintervention was +3.52 ( P < 0.001 ) , although retention was not as strong .
-RESULTS	Neither the attention nor the no-treatment control groups had significant gains immediately postintervention or at follow-up assessments .
-RESULTS	Post hoc across-group comparison of baseline change also highlights the benefits of REAL training .
-RESULTS	For EPCCE , the magnitude of gain was significantly larger in the REAL group versus the no-treatment control group immediately postintervention ( d = 3.82 ; P < 0.01 ) and at the 3-month follow-up ( d = 3.80 ; P < 0.01 ) .
-RESULTS	For DAFS , gain magnitude immediately postintervention for REAL was significantly greater compared with in the attention control group ( d = 4.73 ; P < 0.01 ) .
-CONCLUSIONS	REAL improves skills in everyday problem solving , which may allow AL residents to maintain self-care and extend AL residency .
-CONCLUSIONS	This benefit is particularly important given the growing population of AL residents at risk for cognitive and self-care decline .
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-###24770694
-BACKGROUND	We sought to investigate the clinical relevance of neuroforaminal patency and facet degeneration one year after anterior cervical discectomy and fusion ( ACDF ) .
-BACKGROUND	Previous studies were characterized by imprecise techniques and fragmentary measurements , and most lacked reliable clinical data and correlation analyses .
-METHODS	Patients with cervical mono - or bi-level degenerative pathology were prospectively included .
-METHODS	Neuroforaminal size and segmental height were determined quantitatively , and the degree of facet degeneration was assessed qualitatively before and one year after the operation , by computed tomography .
-METHODS	Clinical data , such as the severity of neck and arm pain , were assessed on a visual analogue scale ( VAS ) from 0 to 10 , and neck disability index ( NDI ) was recorded before and one year after the operation .
-METHODS	Their correlation with radiological data was investigated .
-RESULTS	Seventy-nine patients aged 53.311.3 years were included .
-RESULTS	One year after surgery , median VAS pain intensity was still significantly improved ( neck , from 5 to 1 ; right arm , from 2 to 1 ; left arm , from 4 to 1 ) as was NDI ( from 40 to 20 ) .
-RESULTS	Neuroforaminal size showed a reduction on both sides ( left , 0.02890.09 cm ( 2 ) ; right , 0.01490.08 cm ( 2 ) ) .
-RESULTS	One year after the operation , segmental height decreased and facet degeneration increased from measures taken before the operation .
-RESULTS	No correlations were found between neuroforaminal stenosis or the degree of facet degeneration and various clinical outcome parameters .
-CONCLUSIONS	The decrease in segmental height one year after ACDF leads in turn to secondary neuroforaminal stenosis and progressive facet degeneration .
-CONCLUSIONS	Of the various neuroforaminal variables used , none revealed a threshold value indicative of the presence or severity of radicular arm pain .
-CONCLUSIONS	This absence of correlation between imaging and clinical information is important and should be considered when allocating patients for surgical interventions .
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-###24647464
-BACKGROUND	Inclusion in trials is selective , and thus results may not be generalizable to the general population .
-BACKGROUND	The aim of this study was to investigate the external validity of randomized clinical trial outcomes for elderly breast cancer patients .
-METHODS	We compared characteristics and outcomes of breast cancer patients ( n = 1325 ) who participated in a randomized clinical trial ( Tamoxifen Exemestane Adjuvant Multinational trial ) with unselected breast cancer patients of corresponding age from the general population ( n = 1056 ) .
-METHODS	Dutch patients aged 65 years or older at diagnosis of hormone receptor-positive breast cancer without distant metastases , with either nodal involvement , a tumor greater than 3cm , or a 1 to 3cm histological grade III tumor , who completed local therapy were included .
-METHODS	Analyses were stratified by age ( 65-74 years ; 75 years ) .
-METHODS	Primary outcome was overall mortality .
-METHODS	Multivariable Cox proportional hazards models were used to assess the association between covariables and overall mortality .
-METHODS	All statistical tests were two-sided .
-RESULTS	Irrespective of age , patients who participated in the trial had fewer comorbid diseases , a higher socioeconomic status , and smaller tumors ( all P < .001 ) .
-RESULTS	In patients aged 65 to 74 years , those who participated in the trial had a similar overall mortality to patients from the general population ( multivariable hazard ratio [ HR ] = 1.08 ; 95 % confidence interval [ CI ] = 0.73 to 1.60 ) .
-RESULTS	Alternatively , in patients aged 75 years or older , those who participated in the trial had a lower overall mortality ( multivariable HR = 0.72 ; 95 % CI = 0.55 to 0.95 ; P = .02 ) than patients in the general population .
-CONCLUSIONS	Breast cancer trial participants aged 75 years or older do not represent elderly breast cancer patients of corresponding age from the general population , which hampers the external validity of a trial .
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-###24615831
-BACKGROUND	We previously developed and piloted a telephone-based intimacy enhancement ( IE ) intervention addressing sexual concerns of colorectal cancer patients and their partners in an uncontrolled study .
-BACKGROUND	The current study tested the feasibility , acceptability , and preliminary efficacy of the IE intervention in a randomized , controlled trial .
-METHODS	Twenty-three couples were randomized to either the four-session IE condition or to a wait list control condition and completed sexual and relationship outcomes measures .
-METHODS	The IE intervention teaches skills for coping with sexual concerns and improving intimacy .
-METHODS	Feasibility and acceptability were assessed through enrollment and post-treatment program evaluations , respectively .
-METHODS	Effect sizes were calculated by comparing differences in average pre/post change scores across completers in the two groups ( n = 18 couples ) .
-RESULTS	Recruitment and attrition data supported feasibility .
-RESULTS	Program evaluations for process ( e.g. , ease of participation ) and content ( e.g. , relevance ) demonstrated acceptability .
-RESULTS	Engaging in intimacy-building activities and communication were the skills rated as most commonly practiced and most helpful .
-RESULTS	For patients , positive effects of the IE intervention were found for female and male sexual function , medical impact on sexual function , and self-efficacy for enjoying intimacy ( .58 ) ; no effects were found on sexual distress or intimacy and small negative effects for sexual communication , and two self-efficacy items .
-RESULTS	For partners , positive IE effects were found for all outcomes ; the largest were for sexual distress ( .69 ) , male sexual function ( 1.76 ) , communication ( .97 ) , and two self-efficacy items ( .87 ) .
-CONCLUSIONS	The telephone-based IE intervention shows promise for couples facing colorectal cancer .
-CONCLUSIONS	Larger multi-site intervention studies are necessary to replicate findings .
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-###25156343
-BACKGROUND	Mobility assessment in Multiple Sclerosis ( MS ) is crucial for trials and individual patient counseling .
-BACKGROUND	Up to now , standard tests as the Timed 25-Foot Walk ( T25FW ) are restricted by floor effects in mildly disabled patients .
-BACKGROUND	The 3-meter Timed Tandem Walk ( TTW ) as a possibly more sensitive measure has not been investigated yet .
-OBJECTIVE	To investigate sensitivity and specificity of the TTW and T25FW to detect mild clinical impairment in a large cohort of MS patients .
-METHODS	We extracted T25FW , TTW and EDSS from our UMC patient database ( 2009-2012 ) .
-METHODS	After randomization into an explorative ( n = 497 ) and validation ( n = 228 ) cohort , we calculated change rates and performed ROC analyses of gait tests and EDSS including Functional System Scores .
-RESULTS	Between disability stages of EDSS 0-2 .5 and EDSS 3.0-4 .0 , the mean TTW difference was 4s ( T25FW = 0.9 s ) .
-RESULTS	The accuracy to separate between EDSS groups was moderate but identical for both tests ( ROC-AUC T25FW = 0.79 , TTW = 0.80 , p = 0.4 ) .
-RESULTS	TTW had a higher sensitivity and specificity to differentiate between asymptomatic and symptomatic patients concerning FS motor/cerebellar scores ( ROC-AUC T25FW = 0.71 , TTW = 0.75 , p < 0.05 ) .
-RESULTS	All hypotheses could be validated in the second cohort .
-CONCLUSIONS	A 3-m Timed Tandem Walk is a standardized test that is easy to implement to detect impairment of the motor or cerebellar system in fully ambulatory MS patients .
-CONCLUSIONS	Based on the complex-task character , TTW is a potential new outcome measure for MS mobility in mildly disabled patients and can act as easily accessible and significant additional information in patient counseling .
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-###25000214
-OBJECTIVE	To examine the effect of a 1-time dose of pregabalin ( Lyrica ) on the perception of pain and analgesic consumption after oculofacial plastic surgery .
-METHODS	In this prospective , randomized , double-blind , placebo-controlled trial , patients presenting to the oculofacial plastic surgery service at University of Colorado Eye Center for functional eyelid surgery and who met the study criteria were consecutively enrolled between October 2011 and September 2012 .
-METHODS	Subjects were randomized to either placebo or 150 mg pregabalin administered 15 minutes to an hour prior to the procedure .
-METHODS	The procedure was then performed under the usual standard of care .
-METHODS	Postoperatively , study subjects recorded pain scores on visual analog scales ( range 0-100 ) at 1 to 2 hours , 2 to 4 hours , 8 to 12 hours , 20 to 28 hours , and 36 to 48 hours and the amount of acetaminophen consumed .
-METHODS	Data were analyzed with Statistical Analysis System software using mixed-effects linear models .
-RESULTS	Fifty-two patients were enrolled .
-RESULTS	Three patients were excluded due to incomplete follow up ( n = 2 ) and postoperative course requiring early unblinding ( n = 1 ) .
-RESULTS	Twenty-six subjects were men .
-RESULTS	Average age was 68 years ( range , 25-89 ) .
-RESULTS	Eyelid procedures performed included blepharoplasty ( 18 ) , canthoplasty ( 11 ) , ptosis repair ( 15 ) , eyelid retraction repair ( 2 ) , pentagonal wedge resection ( 1 ) , and MOHS reconstruction ( 2 ) .
-RESULTS	Twenty-six patients were randomized to receive pregabalin , while the remainder received placebo .
-RESULTS	There was no significant difference in demographics between the 2 groups .
-RESULTS	The pregabalin group reported pain scores that were 5.5 points lower on average compared with the placebo group ( p = 0.0307 ) .
-RESULTS	Patients in the pregabalin group also consumed half as much acetaminophen ( 1.3 g ) on average as the placebo group ( 2.6 g ) during the postoperative period .
-CONCLUSIONS	Pregabalin is effective in reducing postoperative pain after oculoplastic procedures when compared with placebo .
-CONCLUSIONS	It may be a useful adjunct for pain control in selected patients .
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-###26465985
-BACKGROUND	Epidemiologic and preclinical data suggest that higher intake and serum levels of vitamin D and higher intake of calcium reduce the risk of colorectal neoplasia .
-BACKGROUND	To further study the chemopreventive potential of these nutrients , we conducted a randomized , double-blind , placebo-controlled trial of supplementation with vitamin D , calcium , or both for the prevention of colorectal adenomas .
-METHODS	We recruited patients with recently diagnosed adenomas and no known colorectal polyps remaining after complete colonoscopy .
-METHODS	We randomly assigned 2259 participants to receive daily vitamin D3 ( 1000 IU ) , calcium as carbonate ( 1200 mg ) , both , or neither in a partial 22 factorial design .
-METHODS	Women could elect to receive calcium plus random assignment to vitamin D or placebo .
-METHODS	Follow-up colonoscopy was anticipated to be performed 3 or 5 years after the baseline examinations , according to the endoscopist 's recommendation .
-METHODS	The primary end point was adenomas diagnosed in the interval from randomization through the anticipated surveillance colonoscopy .
-RESULTS	Participants who were randomly assigned to receive vitamin D had a mean net increase in serum 25-hydroxyvitamin D levels of 7.83 ng per milliliter , relative to participants given placebo .
-RESULTS	Overall , 43 % of participants had one or more adenomas diagnosed during follow-up .
-RESULTS	The adjusted risk ratios for recurrent adenomas were 0.99 ( 95 % confidence interval [ CI ] , 0.89 to 1.09 ) with vitamin D versus no vitamin D , 0.95 ( 95 % CI , 0.85 to 1.06 ) with calcium versus no calcium , and 0.93 ( 95 % CI , 0.80 to 1.08 ) with both agents versus neither agent .
-RESULTS	The findings for advanced adenomas were similar .
-RESULTS	There were few serious adverse events .
-CONCLUSIONS	Daily supplementation with vitamin D3 ( 1000 IU ) , calcium ( 1200 mg ) , or both after removal of colorectal adenomas did not significantly reduce the risk of recurrent colorectal adenomas over a period of 3 to 5 years .
-CONCLUSIONS	( Funded by the National Cancer Institute ; ClinicalTrials.gov number , NCT00153816 . )
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-###24515621
-OBJECTIVE	To investigate the effectivity of pentoxifylline ( PTX ) and immunoglobulin M ( IgM ) - enriched intravenous immunoglobulin ( IVIG ) therapy in the treatment of neonatal sepsis ( NS ) , alone or in combination .
-METHODS	This was a prospective , double-blind , controlled study .
-METHODS	Newborns with suspicion of sepsis were enrolled in the study .
-METHODS	The patients were separated into four groups according to treatment protocol : Group 1 = placebo , Group 2 = pentoxifylline , Group 3 = IgM-enriched IVIG , and Group 4 = pentoxifylline + IgM-enriched IVIG .
-METHODS	Blood samples were taken for C-reactive protein , interleukin-6 , neutrophil CD64 expression , and tumor necrosis factor-alfa measurements immediately before treatment ( 1st day ) , and measurements were repeated on the 2nd and 4th days of the therapy .
-RESULTS	A total of 204 patients , 51 in each group , were recruited into the study .
-RESULTS	There were no significant differences for symptoms of sepsis among groups , except lethargy .
-RESULTS	No significant differences were observed among the groups according to laboratory data .
-RESULTS	Overall mortality rate was 8.8 % .
-RESULTS	The rates of morbidities and mortality among study groups were similar .
-CONCLUSIONS	PTX and IgM-enriched IVIG therapies , either alone or in combination , did not reduce the rates of morbidities and mortality in NS .
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-###24660271
-OBJECTIVE	The objective of this randomized , examiner-blind , parallel , controlled clinical study was to compare the antiplaque/antigingivitis efficacy of an essential oil-containing mouthrinse ( EO ) to a new 0.075 % cetylpyridinium chloride mouthrinse ( CPC ) using a two-week experimental gingivitis model with a 5 % hydroalcohol rinse serving as the negative control .
-METHODS	After signing informed consents and completing baseline examinations , 185 subjects were randomized into three groups .
-METHODS	Subjects began supervised/recorded rinsing with 20 ml of their assigned rinse for 30 seconds twice daily for two weeks , with no mechanical oral hygiene permitted .
-METHODS	Baseline and two-week assessments were conducted as follows : Turesky Modification of the Quigley-Hein Plaque Index ( PI ) , Modified Gingival Index ( MGI ) , and the Gingival Bleeding Index ( BI ) .
-METHODS	Analysis of efficacy variables ( i.e. , mean PI , mean MGI , mean BI , and proportion of bleeding sites derived from the BI ) was performed using a one-way analysis of covariance ( ANCOVA ) .
-RESULTS	Among the 182 subjects who completed the study , the EO rinse showed statistically significant reductions compared to the negative control within the range previously reported in this model ; PI = 36.5 % ( p < 0.001 ) and MGI = 17.5 % ( p < 0.001 ) .
-RESULTS	A 43.2 % reduction in proportion of bleeding sites ( p < 0.001 ) was demonstrated .
-RESULTS	Mean PI , MGI , and proportion of bleeding sites at two weeks were statistically significantly lower for the EO rinse compared to the CPC rinse ( p < 0.001 ) , showing 27.7 % , 11.9 % , and 30.0 % reductions , respectively .
-CONCLUSIONS	An EO rinse provided superior antigingivitis/antiplaque efficacy compared to a 0.075 % CPC rinse in this short-term clinical trial , and demonstrated efficacy within the range shown in previous studies using this model .
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-###25668012
-BACKGROUND	Chinese women tend to have small and dense breasts and ultrasound is a common method for breast cancer screening in China .
-BACKGROUND	However , its efficacy and cost comparing with mammography has not been evaluated in randomised trials .
-METHODS	At 14 breast centres across China during 2008-2010 , 13339 high-risk women aged 30-65 years were randomised to be screened by mammography alone , ultrasound alone , or by both methods at enrollment and 1-year follow-up .
-RESULTS	A total of 12519 and 8692 women underwent the initial and second screenings , respectively .
-RESULTS	Among the 30 cancers ( of which 15 were stage 0/I ) detected , 5 ( 0.72 / 1000 ) were in the mammography group , 11 ( 1.51 / 1000 ) in the ultrasound group , and 14 ( 2.02 / 1000 ) in the combined group ( P = 0.12 ) .
-RESULTS	In the combined group , ultrasound detected all the 14 cancers , whereas mammography detected 8 , making ultrasound more sensitive ( 100 vs 57.1 % , P = 0.04 ) with a better diagnostic accuracy ( 0.999 vs 0.766 , P = 0.01 ) .
-RESULTS	There was no difference between mammography and ultrasound in specificity ( 100 vs 99.9 % , P = 0.51 ) and positive predictive value ( 72.7 vs 70.0 % ; P = 0.87 ) .
-RESULTS	To detect one cancer , the costs of ultrasound , mammography , and combined modality were $ 7876 , $ 45253 , and $ 21599 , respectively .
-CONCLUSIONS	Ultrasound is superior to mammography for breast cancer screening in high-risk Chinese women .
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-###24984928
-OBJECTIVE	To investigate the effects of the pre-emptive local infiltration of dexamethasone vs. levobupivacaine on postoperative pain and morbidity in pediatric adenotonsillectomy patients .
-METHODS	A total of 60 patients ( 32 males and 28 females ) , aged 3-14 years , were included in this double-blind prospective randomized controlled clinical study from September of 2011 until May of 2012 .
-METHODS	Patients admitted for adenotonsillectomies after informed consent was obtained from the parents , and randomized into three groups receiving either dexamethasone sodium phosphate ( Group 1 , mean age 5.9 1.6 ) , levobupivacaine with epinephrine ( Group 2 , mean age 6.1 2.6 ) , or saline ( Group 3 , mean age 6.0 3.4 ) .
-METHODS	Pain scores at the 1st , 4th , 8th , 12th , 16th , and 20th hours , and first , second , third and seventh days post-operatively were recorded by the parents using McGrath 's face scale .
-METHODS	The operation type , operation time and anesthesia time , the time of the first request for postoperative analgesia , and the total number of analgesic interventions were recorded .
-RESULTS	Pain scores were revealed in this order : Group 1 ( steroid ) < Group 2 ( levobupivacaine ) < Group 3 ( saline ) at all times ( p = 0.000 ) .
-RESULTS	The anesthesia times for Group 1 and Group 2 were different ( steroid vs. levobupivacaine ) , and the time to first analgesic was longer in Groups 1 ( steroid ) and 2 ( levobupivacaine ) than in Group 3 ( saline ) ( p < 0.000 ) .
-RESULTS	The total number of analgesic interventions was lower in Group 1 ( steroid ) than in Group 2 ( levobupivacaine ) and Group 3 ( saline ) ( steroid vs. saline , p = 0.000 , and steroid vs. levobupivacaine , p < 0.05 ) .
-CONCLUSIONS	Peritonsillar dexamethasone infiltration was more effective than both levobupivacaine and saline in reducing post-tonsillectomy pain .
-CONCLUSIONS	It was proven to be a safe and effective method .
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-###25173484
-BACKGROUND	A safe , effective vaccine for breastfeeding infants born to HIV-1-positive mothers could complement antiretroviral therapy ( ART ) for prevention of mother-to-child transmission of HIV-1 .
-BACKGROUND	To date , only a few HIV-1 vaccine candidates have been tested in infants .
-METHODS	A phase I/II randomized controlled trial PedVacc 002 was conducted to determine the safety and immunogenicity of a single , low dose of MVA.HIVA vaccine delivered intramuscularly to healthy 20-week-old infants born to HIV-1-positive mothers in Nairobi , Kenya .
-METHODS	Pregnant HIV-1-positive women in the 2nd/3rd trimester of gestation were enrolled , provided with ART and self-selected their infant-feeding modality .
-METHODS	Infants received nevirapine and cotrimoxazole prophylaxis .
-METHODS	At 20 weeks of age , eligible HIV-1-negative infants were randomized to vaccine versus no-treatment arms and followed to 48 weeks of age for assessments of vaccine safety , HIV-1-specific T-cell responses and antibodies to routine childhood vaccines .
-RESULTS	Between February and November 2010 , 182 mothers were screened , 104 were eligible and followed on ART during pregnancy/postpartum , of whom 73 had eligible infants at 20 weeks postpartum .
-RESULTS	Thirty-six infants were randomized to vaccine and 37 to no treatment .
-RESULTS	Eighty-four percent of infants breastfed , and retention at 48 weeks was 99 % .
-RESULTS	Adverse events were rare and similar between the two arms .
-RESULTS	HIV-1-specific T-cell frequencies in interferon - ELISPOT assay were transiently higher in the MVA.HIVA arm ( p = 0.002 ) , but not above the threshold for a positive assay .
-RESULTS	Protective antibody levels were adequate and similar between arms for all routine childhood vaccines except HBV , where 71 % of MVA.HIVA subjects compared to 92 % of control subjects were protected ( p = 0.05 ) .
-CONCLUSIONS	This trial tested for the first time an MVA-vectored candidate HIV-1 vaccine in HIV-1-exposed infants in Africa , demonstrating trial feasibility and vaccine safety , low immunogenicity , and compatibility with routine childhood vaccinations .
-CONCLUSIONS	These results are reassuring for use of the MVA vector in more potent prime-boost regimens .
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-###24772412
-OBJECTIVE	To evaluate the effects of 0.5 % levobupivacaine at 37 C preheated from room temperature , on sensorial block , motor block , and haemodynamics in patients undergoing transurethral prostate resection ( TUR-P ) .
-METHODS	The patients were randomly allocated to two groups : Group I patients were injected with 3 mL 0.5 % levobupivacaine solution which had been kept at room temperature for at least 24 hours and Group II patients were injected with 3 mL 0.5 % levobupivacaine solution which had been kept at 37 C for at least 24 hours .
-METHODS	The patients were examined in terms of sensorial block , motor block , haemodynamic profile , and incidence of side effects .
-RESULTS	No significant difference was found between the groups in terms of demographic data .
-RESULTS	The time to reach T 10 sensory block and the time of starting motor block were found to be significantly shorter in Group II .
-RESULTS	The duration of sensory block over T 10 and T 6 , the duration of L 1 regression , the duration of the sensory block , and the regression time of the motor blocks from 3 to 2 were found to be longer in Group II .
-CONCLUSIONS	The use of 0.5 % levobupivacaine spinal anaesthesia heated to 37 C accelerated the start of sensory and motor block .
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-###24681179
-BACKGROUND	The complexity of pain after laparoscopic cholecystectomy ( LC ) needs multi-module analgesia .
-BACKGROUND	Opioids are widely used for perioperative pain but associated with numerous adverse effects .
-BACKGROUND	We investigated the effect of parecoxib administrated preoperatively and postoperatively for analgesia after ambulatory laparoscopic cholecystectomy .
-METHODS	120 patients scheduled for ambulatory LC with general anesthesia were randomly assigned to three groups : group A received 40 mg parecoxib injection 30-45 min before anesthesia induction and 4 ml saline injection when gallbladder was removed ; group B received 4 ml saline injection 30-45 min before anesthesia induction and 40 mg parecoxib injection when gallbladder was removed ; group C received 4 ml saline injection 30-45 min before anesthesia induction and the time when gallbladder was removed .
-METHODS	We recorded the time achieve to modified Aldrete 's score > 9 in the post-anesthesia care unit ( PACU ) and modified Post-Anesthetic Discharge Scoring System ( PADSS ) > 9 in ambulatory unit .
-METHODS	The visual analog scale ( VAS ) was used to assess the degree of the postoperative pain in the first 24 h , and the numbers of patients who need additional analgesic and postoperative adverse effects were also recorded .
-RESULTS	Patients of group A had a shorter length of stay ( LOS ) in PACU compared to these of group B and group C ( 32.4 7.2 min vs. 39.1 10.4 min and 42.2 7.6 min , P < 0.05 ) .
-RESULTS	Patients of group A also had a shorter discharge time compared to these of group B and group C ( 148.4 39.3 min vs. 187.9 47.7 min and 223.4 52.5 min , P < 0.05 ) .
-RESULTS	Moreover , patients of group A experienced reduced pain intensity , less postoperative side effect , and less additional analgesic requirement .
-CONCLUSIONS	Preoperative administration of parecoxib for postoperative analgesia provided significant effect on reducing PACU length of stay ( LOS ) and discharge time , and improving patient outcome after ambulatory LC .
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-###25189764
-BACKGROUND	Hyperglycemia is a marker of poor prognosis in severe brain injuries .
-BACKGROUND	There is currently little data regarding the effects of intensive insulin therapy ( IIT ) on neurological recovery .
-METHODS	A sub-group analysis of the randomized-controlled CGAO-REA study ( NCT01002482 ) in surgical intensive care units ( ICU ) of two university hospitals .
-METHODS	Patients with severe brain injury , with an expected ICU length of stay 48 hours were included .
-METHODS	Patients were randomized between a conventional glucose management group ( blood glucose target between 5.5 and 9 mmol.L ( -1 ) ) and an IIT group ( blood glucose target between 4.4 and 6 mmol.L ( -1 ) ) .
-METHODS	The primary outcome was the day-90 neurological outcome evaluated with the Glasgow outcome scale .
-RESULTS	A total of 188 patients were included in this analysis .
-RESULTS	In total 98 ( 52 % ) patients were randomized in the control group and 90 ( 48 % ) in the IIT group .
-RESULTS	The mean Glasgow coma score at baseline was 7 ( 4 ) .
-RESULTS	Patients in the IIT group received more insulin ( 130 ( 68 to 251 ) IU versus 74 ( 13 to 165 ) IU in the control group , P = 0.01 ) , had a significantly lower morning blood glucose level ( 5.9 ( 5.1 to 6.7 ) mmol.L ( -1 ) versus 6.5 ( 5.6 to 7.2 ) mmol.L ( -1 ) , P < 0.001 ) in the first 5 days after ICU admission .
-RESULTS	The IIT group experienced more episodes of hypoglycemia ( P < 0.0001 ) .
-RESULTS	In the IIT group 24 ( 26.6 % ) patients had a favorable neurological outcome ( good recovery or moderate disability ) compared to 31 ( 31.6 % ) in the control group ( P = 0.4 ) .
-RESULTS	There were no differences in day-28 mortality .
-RESULTS	The occurrence of hypoglycemia did not influence the outcome .
-CONCLUSIONS	In this sub-group analysis of a large multicenter randomized trial , IIT did not appear to alter the day-90 neurological outcome or ICU morbidity in severe brain injured patients or ICU morbidity .
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-###25408222
-BACKGROUND	Patients with Alzheimer 's disease ( AD ) exhibit significantly less macular pigment ( MP ) and poorer vision when compared to control subjects .
-OBJECTIVE	To investigate supplementation with the macular carotenoids on MP , vision , and cognitive function in patients with AD versus controls .
-METHODS	A randomized , double-blind clinical trial with placebo and active arms .
-METHODS	31 AD patients and 31 age-similar control subjects were supplemented for six months with either Macushield ( 10 mg meso-zeaxanthin [ MZ ] ; 10 mg lutein [ L ] ; 2 mg zeaxanthin [ Z ] ) or placebo ( sunflower oil ) .
-METHODS	MP was measured using dual-wavelength autofluorescence ( Heidelberg Spectralis ) .
-METHODS	Serum L , Z , and MZ were quantified by high performance liquid chromatography .
-METHODS	Visual function was assessed by best corrected visual acuity and contrast sensitivity ( CS ) .
-METHODS	Cognitive function was assessed using a battery of cognition tests , including the Cambridge Neuropsychological Test Automated Battery ( CANTAB ) ) .
-RESULTS	Subjects on the active supplement ( for both AD and non-AD controls ) exhibited statistically significant improvement in serum concentrations of L , Z , MZ , and MP ( p < 0.001 , for all ) and also CS at ( p = 0.039 ) .
-RESULTS	Also , for subjects on the active supplement , paired samples t-tests exhibited four significant results ( from five spatial frequencies tested ) in the AD group , and two for the non-AD group , and all indicating improvements in CS .
-RESULTS	We found no significant changes in any of the cognitive function outcome variables measured ( p > 0.05 , for all ) .
-CONCLUSIONS	Supplementation with the macular carotenoids ( MZ , Z , and L ) benefits patients with AD , in terms of clinically meaningful improvements in visual function and in terms of MP augmentation .
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-###24363547
-BACKGROUND	Limited data exist on cotrimoxazole prophylactic treatment ( CPT ) in pregnant women , including protection against malaria versus standard intermittent preventive therapy with sulfadoxine-pyrimethamine ( IPTp ) .
-METHODS	Using observational data we examined the effect of CPT in HIV-infected pregnant women on malaria during pregnancy , low birth weight and preterm birth using proportional hazards , logistic , and log binomial regression , respectively .
-METHODS	We used linear regression to assess effect of CPT on CD4 count .
-RESULTS	Data from 468 CPT-exposed and 768 CPT-unexposed women were analyzed .
-RESULTS	CPT was associated with protection against malaria versus IPTp ( hazard ratio : 0.35 , 95 % Confidence Interval ( CI ) : 0.20 , 0.60 ) .
-RESULTS	After adjustment for time period this effect was not statistically significant ( adjusted hazard ratio : 0.66 , 95 % CI : 0.28 , 1.52 ) .
-RESULTS	Among women receiving and not receiving CPT , rates of low birth weight ( 7.1 % versus 7.6 % ) and preterm birth ( 23.5 % versus 23.6 % ) were similar .
-RESULTS	CPT was associated with lower CD4 counts 24 weeks postpartum in women receiving ( -77.6 cells / L , 95 % CI : -125.2 , -30.1 ) and not receiving antiretrovirals ( -33.7 cells / L , 95 % CI : -58.6 , -8.8 ) .
-CONCLUSIONS	Compared to IPTp , CPT provided comparable protection against malaria in HIV-infected pregnant women and against preterm birth or low birth weight .
-CONCLUSIONS	Possible implications of CPT-associated lower CD4 postpartum warrant further examination .
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-###24697827
-BACKGROUND	Diet might influence progression of hypertrophic cardiomyopathy ( HCM ) .
-OBJECTIVE	To investigate whether diet composition could alter clinical , biochemical , or echocardiographic variables in cats with HCM .
-METHODS	Twenty-nine cats with HCM ( International Small Animal Cardiac Health Council stage 1b ) examined at a university teaching hospital .
-METHODS	Randomized , placebo-controlled trial .
-METHODS	After physical examination , echocardiogram , and blood collection , cats were randomized to 1 of 3 diets , which varied in carbohydrate and fat content and ingredients .
-METHODS	Measurements were repeated after 6 months .
-RESULTS	There were no significant differences among the 3 groups at baseline .
-RESULTS	After 6 months , there were no significant changes in the primary endpoints , left ventricular free wall ( Group A , P = .760 ; Group B , P = .475 ; Group C , P = .066 ) or interventricular septal thickness in diastole ( Group A , P = .528 ; Group B , P = .221 ; Group C , P = .097 ) .
-RESULTS	Group A had significant increases in BUN ( P = .008 ) and cholesterol ( P = .021 ) , while Group B had significant increases in BUN ( P = .008 ) , cholesterol ( P = .007 ) , and triglycerides ( P = .005 ) , and significant decreases in NT-proBNP ( P = .013 ) and hs-troponin I ( P = .043 ) .
-RESULTS	Group C had significant decreases in body weight ( P = .021 ) , left atrial dimension ( P = .035 ) , interventricular septal thickness in systole ( P = .038 ) , and liver enzymes ( P = .034 -.038 ) .
-CONCLUSIONS	These data suggest that diet might influence some clinical , biochemical , and echocardiographic variables in cats with HCM .
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-###24279607
-OBJECTIVE	The purpose of this clinical investigation was to evaluate long-term results obtained with the combination of platelet pellet ( PP ) plus bioabsorbable barrier membrane ( BM ) and to compare this outcome with the results obtained using bioactive glass ( BG ) graft material with a BM .
-METHODS	Using a split mouth design , 11 chronic periodontitis patients ( power at least 80 % ) were randomly assigned to treatment with a combination of PP/GTR or BG/GTR in contra-lateral dentition areas .
-METHODS	Clinical attachment level ( CAL ) as the primary outcome variable , calculated as the sum of probing pocket depth ( PPD ) and gingival recession , and radiological alveolar bone level were recorded at baseline , 6 months and 5 years .
-RESULTS	There were no statistical differences between test and control defects at baseline .
-RESULTS	PPD reductions and CAL and radiological alveolar bone height gains were statistically significant between baseline and 6 months and between baseline and 5 years in both groups ( p < 0.01 ) .
-RESULTS	Six months results of frequency distribution showed that 82 % of the defects attained 4 mm CAL gain in both groups , while 5 year results showed that 73 % of the defects attained 2 mm CAL gain < 4 mm in the PP/BM group and 55 % of the defects attained 2 mm CAL gain < 4 mm in the BG/BM group .
-RESULTS	All parameters evaluated showed no significant differences between 6 months and 5 years in both groups ( p > 0.05 ) .
-RESULTS	No statistically significant difference in any of the clinical parameters was observed at 6 months and 5 years between the groups ( p > 0.05 ) .
-CONCLUSIONS	The long-term efficacy of platelet concentrate combined with a barrier membrane is similar with the combination of bioactive glass graft material and barrier membrane , suggesting that results obtained with both treatment approaches can be maintained over a period of 5 years .
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-###24607773
-OBJECTIVE	Endothelin-1 contributes to endothelial dysfunction in patients with atherosclerosis and type 2 diabetes .
-OBJECTIVE	In healthy arteries the ETA receptor mediates the main part of the vasoconstriction induced by endothelin-1 whilst the ETB receptor mediates vasodilatation .
-OBJECTIVE	The ETB receptor expression is upregulated on vascular smooth muscle cells in atherosclerosis and may contribute to the increased vasoconstrictor tone and endothelial dysfunction observed in this condition .
-OBJECTIVE	Due to these opposing effects of the ETB receptor it remains unclear whether ETB blockade together with ETA blockade may be detrimental or beneficial .
-OBJECTIVE	The aim was therefore to compare the effects of selective ETA and dual ETA/ETB blockade on endothelial function in patients with type 2 diabetes and coronary artery disease .
-METHODS	Forearm endothelium-dependent and endothelium-independent vasodilatation was assessed by venous occlusion plethysmography in 12 patients before and after selective ETA or dual ETA/ETB receptor blockade .
-RESULTS	Dual ETA/ETB receptor blockade increased baseline forearm blood flow by 3014 % ( P < 0.01 ) whereas selective ETA blockade did not ( 148 % ) .
-RESULTS	Both selective ETA blockade and dual ETA/ETB blockade significantly improved endothelium-dependent vasodilatation .
-RESULTS	The improvement did not differ between the two treatments .
-RESULTS	There was also an increase in endothelium-independent vasodilatation with both treatments .
-RESULTS	Dual ETA/ETB blockade did not significantly increase microvascular flow but improved transcutaneous pO2 .
-CONCLUSIONS	Both selective ETA and dual ETA/ETB improve endothelium-dependent vasodilatation in patients with type 2 diabetes and coronary artery disease .
-CONCLUSIONS	ETB blockade increases basal blood flow but does not additionally improve endothelium-dependent vasodilatation .
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-###25399620
-BACKGROUND	Human skin aging is a multifactorial and complex biological process affecting the different skin constituents .
-BACKGROUND	Even if the skin aging mechanism is not yet fully unravelled is evident that epidermis loses the principal molecule responsible for binding and retaining water molecules , resulting in loss of skin moisture and accounting for some of the most striking alterations of the aged skin .
-OBJECTIVE	This Study investigated the cosmetic filling efficacy of Fillerina in decreasing the skin aging signs and in improving facial volume deficiencies .
-METHODS	A placebo-controlled , double-blind , randomized clinical trial was carried out on 40 healthy female subjects showing mild to moderate clinical signs of skin aging .
-METHODS	The effect of the treatment on skin surface and on face volumes was assessed both in the short-term ( 3 h after a single product application ) and in the long-term ( 7 , 14 , and 30 days after continuative daily use ) .
-RESULTS	Three hours after a single application and after 7 , 14 , and 30 days of treatment the lips volume was increased by 8.5 % , 11.3 % , 12.8 % , and 14.2 % .
-RESULTS	After 7 , 14 , and 30 days : ( 1 ) skin sagging of the face contours was decreased by -0.443 0.286 , -1.124 0.511 , and -1.326 0.649 mm , respectively ; ( 2 ) skin sagging of the cheekbones contours was decreased by -0.989 0.585 , -2.500 0.929 , and -2.517 0.927 mm , respectively ; ( 3 ) cheekbones volume was increased by 0.875 0.519 , 2.186 0.781 , and 2.275 0.725 mm , respectively ; ( 4 ) wrinkle volume was decreased by -11.3 % , -18.4 % , and -26.3 % , respectively ; and ( 5 ) wrinkle depth was decreased by -8.4 % , -14.5 % , and -21.8 % respectively .
-CONCLUSIONS	This study demonstrated the positive filling effect of Fillerina in decreasing the clinical signs of skin aging and in improving the face volumes .
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-###25326126
-BACKGROUND	To examine bowel wall edema development in laparoscopic and open major visceral surgery .
-METHODS	In a prospective study , 47 consecutively operated patients with gastric and pancreatic resections were included .
-METHODS	Twenty-seven patients were operated in a conventional open procedure ( open group ) and 20 in a laparoscopic fashion ( lap group ) .
-METHODS	In all procedures , a small jejunal segment was resected during standard preparation , of which we measured the dry-wet ratio .
-METHODS	Furthermore , HE staining was performed for measuring of bowel wall thickness and edema assessment .
-RESULTS	Mean value ( std ) of dry-wet ratio was significantly lower in the open than in the lap group ( 0.1690.017 versus 0.1790.015 ; p = 0.03 ) with the same amount of fluid administration in both groups and a longer infusion interval during laparoscopic surgery .
-RESULTS	Subgroup analyses ( only pancreatic resections ) still showed similar results .
-RESULTS	Histologic examination depicted a significantly larger bowel wall thickness in the open group .
-CONCLUSIONS	Laparoscopic surgery does not seem to lead to the bowel wall edema observed to occur in open surgery regardless of the degree of intravenous fluid administration , thus supporting its use even in major visceral surgery .
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-###25594526
-OBJECTIVE	Testing the ability to program IVF GnRH-antagonist cycles to avoid weekend oocyte retrieval .
-METHODS	Preliminary randomized clinical trial .
-METHODS	Patients presenting an indication for IVF or IVF-ICSI were assigned into either the Treatment Group - GnRH antagonist protocol , programmed to start stimulatory agents on a Friday , with oral 2mg estradiol valerate twice a day from the 2nd day of cycle until the first Friday to follow , or to the Control Group - long luteal GnRH agonist protocol .
-RESULTS	The performance of 27 Treatment Group patients and 24 Control Group patients was analyzed .
-RESULTS	Cycle dynamics were not clinically or statistically different except for a significant difference in the number of follicles measuring 18 mm on hCG administration day .
-RESULTS	There were no differences in the number of aspirated ova , fertilization rates , embryo quality or number of embryos to be transferred .
-RESULTS	Pregnancy rate was 41.7 % in the Treatment Group and 50 % in the Control Group ( P > 0.5 ) .
-RESULTS	Only one patient assigned to the Treatment Group had a weekend retrieval .
-CONCLUSIONS	Preliminary results demonstrate no compromise related to follicular estrogen programming in a GnRH antagonist protocol and provide reassurance regarding the ability to achieve programming goals .
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-###25079882
-BACKGROUND	Intimate partner violence ( IPV ) victimization is a prevalent issue among women residing in Mexico City .
-BACKGROUND	Comprehensive and integrated health care provider ( HCP ) delivered programs in clinic-settings are needed , yet few have been evaluated in Latin America , including Mexico .
-BACKGROUND	In addition , there has been minimal attention to interventions among lower income women presenting at settings outside of antenatal care clinics .
-BACKGROUND	The current randomized controlled trial seeks to increase midlevel HCPs ' capacity , specifically nurses , who are often the first point of contact in this setting , to identify women presenting at health clinics with experiences of IPV and to assist these women with health risk mitigation .
-BACKGROUND	Specific outcomes include changes in past-year IPV ( physical and/or sexual ) , reproductive coercion , safety planning , use of community resources , and quality of life .
-METHODS	Forty-two public health clinics in Mexico City were randomized to treatment or control clinics .
-METHODS	Nurses meeting eligibility criteria in treatment groups received an intensive training on screening for IPV , providing supportive referrals , and assessing for health and safety risks .
-METHODS	Nurses meeting eligibility criteria at control clinics received the standard of care which included a one-day training focused on sensitizing staff to IPV as a health issue and referral cards to give to women .
-METHODS	Women were screened for eligibility ( currently experiencing abuse in a heterosexual relationship , 18-44 years of age , non-pregnant or in first trimester ) by research assistants in private areas of waiting rooms in health clinics .
-METHODS	Consenting women completed a baseline survey and received the study protocol for that clinic .
-METHODS	In treatment clinics , women received the nurse delivered session at baseline and received a follow-up counseling session after three months .
-METHODS	Surveys are conducted at baseline , three months , and fifteen months from baseline .
-CONCLUSIONS	This study will provide important insight into whether a nurse-delivered program can assist women currently experiencing abuse in a Latin American context .
-CONCLUSIONS	Findings can be used to inform IPV programs and policies in Mexico City 's public health clinics .
-BACKGROUND	NCT01661504 .
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-###24631095
-BACKGROUND	Japanese encephalitis ( JE ) is the most important cause of viral encephalitis in Asia .
-METHODS	In this randomized , open-label , multicenter trial in 550 children aged 12 to 18 months in Taiwan , children received one dose of JE-CV and one dose of MMR vaccine .
-METHODS	Vaccines were either administered separately 6 weeks apart ( Groups ` JE-CV ' and ` MMR ' , named after which vaccine was given first ) , or concomitantly ( Group ` Co-Ad ' ) .
-METHODS	JE neutralizing antibody titers were assessed using PRNT50 .
-METHODS	MMR antibody levels were determined by ELISA .
-RESULTS	All groups had low seroprotection/seropositivity rates ( < 10 % ) before vaccination for all antigens .
-RESULTS	Forty two days after vaccination , on either Study Day 42 or 84 , seroconversion rates for all antigens were high in all groups , irrespective of the order of vaccinations .
-RESULTS	Seroconversion for JE ranged from 96.9 % in Group Co-Ad on D42 to 100 % in Group MMR .
-RESULTS	Non-inferiority was demonstrated for all analyses as the lower bound of the 95 % CI of the difference in seroconversion rates between groups was above the pre-defined limit of -10.0 % .
-RESULTS	The immune responses remained high for all antigens and well above the level of protection 12 months after vaccination in all groups .
-RESULTS	There were no safety concerns .
-CONCLUSIONS	JE-CV is safe and induces a strong protective immune response which persists over 1 year when co-administered with MMR vaccine .
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-###24267484
-BACKGROUND	Inguinal hernia is one of the most common diseases in the elderly .
-BACKGROUND	Treatment of this pathology is exclusively surgical and relies almost always on the use of local anesthesia .
-BACKGROUND	While in the past hernia surgery was carried out mainly by general anesthesia , in recent years there has been growing emphasis on the role of local anesthesia .
-METHODS	The aim of our study was to compare intra-and postoperative analgesia obtained by the use of levobupivacaine to the same obtained by bupivacaine .
-METHODS	Bupivacaine is one of the main local anesthetics used in the intervention of inguinal hernioplasty .
-METHODS	Levobupivacaine is an enantiomer of racemic bupivacaine with less cardiotoxicity and neurotoxicity .
-METHODS	The study was conducted from March 2011 to March 2013 .
-METHODS	We collected data of eighty patients , male and female , aged between 65 and 86 years , who underwent inguinal hernioplasty with local anesthesia .
-RESULTS	Evaluation of intra-operatively pain shows that minimal pain is the same in both groups .
-RESULTS	Mild pain was more frequent in the group who used levobupivacaine .
-RESULTS	Moderate pain was slightly more frequent in the group who used bupivacaine .
-RESULTS	Only one reported intense pain .
-RESULTS	Two drugs seem to have the same effect at a distance of six , twelve , eighteen and twentyfour hours .
-RESULTS	Bupivacaine shows a significantly higher number of complications , as already demonstrated by previous studies .
-RESULTS	Degree of satisfaction expressed by patients has been the same in the two groups .
-RESULTS	Levobupivacaine group has shown a greater request for paracetamol while patients who experienced bupivacaine have showed a higher request of other analgesics .
-CONCLUSIONS	Clinical efficacy of levobupivacaine and racemic bupivacaine are actually similar , when used under local intervention of inguinal hernioplasty .
-CONCLUSIONS	In the field of ambulatorial surgery our working group prefers levobupivacaine for its fewer side effects and for its easy handling .
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-###24361998
-BACKGROUND	Spondylodesis in the operative management of lumbar spine diseases has been the subject of numerous studies over several decades .
-BACKGROUND	The posterolateral fusion ( PLF ) with pedicle screw fixation is a commonly used procedure .
-OBJECTIVE	To determine whether the addition of bone marrow concentrate ( BMC ) to allograft bone increases fusion rate after instrumented posterior lumbar fusion .
-METHODS	The study was prospective , randomized , controlled , and blinded .
-METHODS	Eighty patients with degenerative disease of the lumbar spine underwent instrumented lumbar or lumbosacral PLF ( 22 men , 58 women ; body mass index less than 35 for a good visualization of the PLF in the X-rays ) .
-METHODS	In 40 cases , the PLF was done with spongious allograft chips alone ( Group I , age 62.7 years in average , range 47-77 years , level of fusion 1-2 ) .
-METHODS	In another 40 cases , spongious allograft chips were mixed with BMC ( Group II , age 58.5 years in average , range 42-80 , level of fusion 1-3 ) , including the mesenchymal stem cells ( MSCs ) .
-METHODS	Patients were scheduled for anteroposterior and lateral radiographs 12 and 24 months after the surgery and for computed tomography scanning 24 months after the surgery .
-METHODS	Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation .
-METHODS	The bony mass was judged as fused if there was uninterrupted bridging of well-mineralized bone between the transverse processes or sacrum , with trabeculation indicating bone maturation on least at one side of the spines .
-RESULTS	In Group I at 12 months , the bone graft mass was assessed in X-rays as fused in no cases ( 0 % ) and at 24 months in four cases ( 10 % ) .
-RESULTS	In Group II , 6 cases ( 15 % ) achieved fusion at 12 months and 14 cases ( 35 % ) at 24 months .
-RESULTS	The statistically significant difference between both groups was proven for complete fusion at both 12 ( p = .041 ) and 24 months ( p = .011 ) .
-RESULTS	Computed tomography scans showed that 16 cases ( 40 % ) in Group I and 32 cases ( 80 % ) in Group II had evidence of at least unilateral continuous bridging bone between neighboring vertebrae at 24 months ( p < .05 ) .
-CONCLUSIONS	We have confirmed the hypothesis that the autologous BMC together with theallograft is a better alternative for PLF than the allograft alone .
-CONCLUSIONS	The use of autologous MSCs in form of BMC in combination with allograft is an effective option to enhance the PLF healing .
-
-###24740713
-OBJECTIVE	There is controversy on whether lowering or restricting the level of sympathectomy can reduce compensatory sweating ( CS ) .
-OBJECTIVE	This study compared the results from sympathectomies performed to treat severe palmar hyperhidrosis using two distinct levels of T2-4 and T3-4 .
-METHODS	One hundred and sixteen patients with primary palmar hyperhidrosis were randomly allocated to undergo either T2-4 sympathectomy treatment ( T2-4 group ) or T3-4 sympathectomy treatment ( T3-4 group ) .
-METHODS	Follow-up data were collected using a telephone questionnaire to assess efficacy , side effects , overall satisfaction , and factors affecting CS and the degree of satisfaction .
-RESULTS	There were no significant differences with respect to either CS or severe CS between the two treatment groups at 1 , 6 , or 12months of follow-up .
-RESULTS	The total scores of the quality-of-life questionnaires after surgery were remarkably decreased compared with those before surgery in the two groups .
-RESULTS	However , no significant differences in quality-of-life scores were found between the two groups before surgery , or at 1 , 6 , or 12months of follow-up .
-RESULTS	Age was predictive of severe CS at 6months of follow-up ( P = 0.045 ) .
-RESULTS	Severe CS was inversely associated with patient satisfaction at 1 , 6 , and 12months of follow-up .
-CONCLUSIONS	The issue of whether lowering or restricting the level of sympathectomy reduces CS is controversial and needs more supportive evidence .
-CONCLUSIONS	Age may be a predictive factor for severe CS at 6 and 12months of follow-up .
-CONCLUSIONS	Severe CS is the only known factor that affects patient satisfaction , and family history may also be associated with patient satisfaction .
-
-###24650695
-OBJECTIVE	The aim of this randomized comparative trial ( RCT ) is to compare partial hepatectomy ( PH ) with transcatheter arterial chemoembolization ( TACE ) to treat patients with resectable multiple hepatocellular carcinoma ( RMHCC ) outside of Milan Criteria .
-METHODS	This RCT was conducted on 173 patients with RMHCC outside of Milan Criteria ( a solitary tumor up to 5 cm or multiple tumors up to 3 in number and up to 3 cm for each tumor ) who were treated in our centre from November 2008 to September 2010 .
-METHODS	The patients were randomly assigned to the PH group or the TACE group .
-METHODS	The primary outcome measure was overall survival ( OS ) from the date of treatment .
-METHODS	A multivariate Cox proportional hazards regression analysis was performed to assess the prognostic risk factors associated with OS .
-RESULTS	The 1 - , 2 - , and 3-year OS rates were 76.1 % , 63.5 % , and 51.5 % , respectively , for the PH group compared with 51.8 % , 34.8 % , and 18.1 % , respectively , for the TACE group ( Log-rank test , ( 2 ) = 24.246 , p < 0.001 ) .
-RESULTS	Multivariate Cox proportional hazards regression analysis revealed the type of treatment ( hazard ratio , 0.434 ; 95 % CI , 0.293 to 0.644 , p < 0.001 ) , number of tumor ( hazard ratio , 1.758 ; 95 % CI , 1.213 to 2.548 , p = 0.003 ) and gender ( hazard ratio , 0.451 ; 95 % CI , 0.236 to 0.862 , p = 0.016 ) were significant independent risk factors associated with OS .
-CONCLUSIONS	PH provided better OS for patients with RMHCC outside of Milan Criteria than conventional TACE .
-CONCLUSIONS	The number of tumor and gender were also independent risk factors associated with OS for RMHCC .
-
-###25705872
-OBJECTIVE	The US Food and Drug Administration adopted labeling for nicotine patches to allow use beyond the standard 8 weeks .
-OBJECTIVE	This decision was based in part on data showing increased efficacy for 24 weeks of treatment .
-OBJECTIVE	Few studies have examined whether the use of nicotine patches beyond 24 weeks provides additional therapeutic benefit .
-OBJECTIVE	To compare 8 ( standard ) , 24 ( extended ) , and 52 ( maintenance ) weeks of nicotine patch treatment for promoting tobacco abstinence .
-METHODS	We recruited 525 treatment-seeking smokers for a randomized clinical trial conducted from June 22 , 2009 , through April 15 , 2014 , through 2 universities .
-METHODS	Smokers received 12 smoking cessation behavioral counseling sessions and were randomized to 8 , 24 , or 52 weeks of nicotine patch treatment .
-METHODS	The primary outcome was 7-day point prevalence abstinence , confirmed with breath levels of carbon monoxide at 6 and 12 months ( intention to treat ) .
-RESULTS	At 24 weeks , 21.7 % of participants in the standard treatment arm were abstinent , compared with 27.2 % of participants in the extended and maintenance treatment arms ( ( 2 ) ( 1 ) = 1.98 ; P = .17 ) .
-RESULTS	In a multivariate model controlled for covariates , participants in the extended and maintenance treatment arms reported significantly greater abstinence rates at 24 weeks compared with participants in the standard treatment arm ( odds ratio [ OR ] , 1.70 [ 95 % CI , 1.03-2 .81 ] ; P = .04 ) , had a longer duration of abstinence until relapse ( = 21.30 [ 95 % CI , 10.30-32 .25 ] ; P < .001 ) , reported smoking fewer cigarettes per day if not abstinent ( mean [ SD ] , 5.8 [ 5.3 ] vs 6.4 [ 5.1 ] cigarettes per day ; = 0.43 [ 95 % CI , 0.06-0 .82 ] ; P = .02 ) , and reported more abstinent days ( mean [ SD ] , 80.5 [ 38.1 ] vs 68.2 [ 43.7 ] days ; OR , 1.55 [ 95 % CI , 1.06-2 .26 ] ; P = .02 ) .
-RESULTS	At 52 weeks , participants in the maintenance treatment arm did not report significantly greater abstinence rates compared with participants in the standard and extended treatment arms ( 20.3 % vs 23.8 % ; OR , 1.17 [ 95 % CI , 0.69-1 .98 ] ; P = .57 ) .
-RESULTS	Similarly , we found no difference in week 52 abstinence rates between participants in the extended and standard treatment arms ( 26.0 % vs 21.7 % ; OR , 1.33 [ 95 % CI , 0.72-2 .45 ] ; P = .36 ) .
-RESULTS	Treatment duration was not associated with any adverse effects or adherence to the counseling regimen , but participants in the maintenance treatment arm reported lower adherence to the nicotine patch regimen compared with those in the standard and extended treatment arms ( mean [ SD ] , 3.94 [ 2.5 ] , 4.61 [ 2.0 ] , and 4.7 [ 2.4 ] patches/wk , respectively ; F2 ,522 = 6.03 ; P = .003 ) .
-CONCLUSIONS	The findings support the safety of long-term use of nicotine patch treatment , although they do not support efficacy beyond 24 weeks of treatment in a broad group of smokers .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01047527 .
-
-###25587020
-BACKGROUND	Preexposure prophylaxis ( PrEP ) with emtricitabine plus tenofovir disoproxil fumarate ( FTC/TDF ) or TDF alone reduces the risk of human immunodeficiency virus ( HIV ) acquisition .
-BACKGROUND	Understanding the risk of antiretroviral resistance selected by PrEP during breakthrough infections is important because of the risk of treatment failure during subsequent antiretroviral use .
-METHODS	Within the largest randomized trial of FTC/TDF versus TDF as PrEP , plasma samples were tested for HIV with resistance mutations associated with FTC ( K65R and M184IV ) and TDF ( K65R and K70E ) , using 454 sequencing .
-RESULTS	Of 121 HIV seroconverters , 25 received FTC/TDF , 38 received TDF , and 58 received placebo .
-RESULTS	Plasma drug levels in 26 individuals indicated PrEP use during or after HIV acquisition , of which 5 had virus with resistance mutations associated with their PrEP regimen .
-RESULTS	Among those with PrEP drug detected during infection , resistance was more frequent in the FTC/TDF arm ( 4 of 7 [ 57 % ] ) , compared with the TDF arm ( 1 of 19 [ 5.3 % ] ; P = .01 ) , owing to the FTC-associated mutation M184IV .
-RESULTS	Of these cases , 3 had unrecognized acute infection at PrEP randomization , and 2 were HIV negative at enrollment .
-CONCLUSIONS	These results suggest that resistance selected by PrEP is rare but can occur both with PrEP initiation during acute seronegative HIV infection and in PrEP breakthrough infections and that FTC is associated with a greater frequency of resistance mutations than TDF .
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-###25179849
-OBJECTIVE	To follow children with juvenile idiopathic arthritis ( JIA ) who had completed at least 6 months of the TRial of Early Aggressive Therapy ( TREAT ) clinical study for an additional 2 years , describing safety of early aggressive treatment , disease activity , function , and duration of clinical inactive disease ( CID ) during followup .
-METHODS	Children were treated as per provider 's discretion .
-METHODS	Physician , patient/parent , and laboratory measures of disease status as well as safety information were collected at clinic visits every 3 months for up to 2 years .
-RESULTS	Forty-eight children were followed for a mean of 28 months ( range 12-42 ) beyond the end of the TREAT study .
-RESULTS	Half of patients were in CID for > 50 % of their followup time .
-RESULTS	Overall , 88 % of patients achieved CID at > 1 study visit and 54 % achieved clinical remission while taking medication .
-RESULTS	Six patients were in CID for the duration of the study , and , of those , 2 achieved a full year of clinical remission while not taking medication .
-RESULTS	Active disease was mild : mean physician 's global assessment 2.4 , active joint count 3.5 , parent global evaluation 2.4 , Childhood Health Assessment Questionnaire 0.32 , erythrocyte sedimentation rate 19 mm/h , and morning stiffness 23 min .
-RESULTS	There were no serious adverse events or adverse events reported at grade 3 or higher of Common Terminology Criteria for Adverse Events .
-CONCLUSIONS	Early aggressive therapy in this cohort of patients with polyarticular JIA who had high initial disease activity was associated with prolonged periods of CID in the majority of patients during followup .
-CONCLUSIONS	Those not in CID had low levels of disease activity .
-
-###25322540
-OBJECTIVE	The aim of the study was to investigate to what extent sweeping of the membranes contributes to cervical shortening and if cervical shortening is related to the time to onset of labor and duration of the active phase of labor
-METHODS	This prospective randomized clinical trial was performed at Baskent University between February and March 2011 .
-METHODS	Women were randomly assigned to receive membrane sweeping ( Sweeping Group ) ( n = 69 ) or no membrane sweeping ( Control Group ) ( n = 71 ) .
-METHODS	Cervical length was measured ( cervix1 ) in both groups by examiner 1 and the Bishop Score was determined in the control group and sweeping was performed in the sweeping group by examiner 2 .
-METHODS	Two days later the patients had another cervical length measurement ( cervix 2 ) by examiner 1 , blinded to the group and results of the examiner 2 .
-METHODS	t test , Mann-Whitney U test and Chi-square test were used for statistical analyses .
-RESULTS	Cervix 1 was 27.4 + / - 8.4 mm and 29.6 + / - 8.9 mm ( p = 0.14 ) , cervix 2 was 23.3 + / - 8.8 mm and 23.8 + / - 8.5 mm ( p = 0.28 ) and cervical shortening was 5 + / - 4 mm and 5 + / -4 mm ( p = 0.446 ) , time to onset of labor was 6.3 + / - 4.6 and 5.7 + / - 4.7 ( p = 0.38 ) and duration of labor was 5.8 + / - 2.89 and 5.7 + / - 2.4 ( p = 0.82 ) for the sweeping and the control groups , respectively
-CONCLUSIONS	Sweeping of the membranes does not reduce cervical length and does not shorten time to onset of labor and duration of the active phase of labor NCT 1309308 : Sweeping the Membranes , Cervical Length and Duration of Labor
-
-###24263121
-BACKGROUND	Although dobutamine stress echocardiography ( DSE ) is performed in heart transplant patients , the safety profile of atropine administration in DSE in this setting is unclear .
-RESULTS	We identified heart transplant patients who received atropine during DSE from January 1984 to August 2011 at our institution and compared them with a propensity-scored matched control group of heart transplant patients who underwent DSE without atropine .
-RESULTS	Adverse events were defined as significant arrhythmias ( sinus arrest , Mobitz type II heart block , complete heart block , ventricular tachycardia , or ventricular fibrillation ) , hypotension requiring hospitalization , syncope or presyncope , myocardial infarction , and death .
-RESULTS	Forty-five heart transplant patients ( median age 62 years , 82 % male ) received 0.2-1 mg atropine during DSE .
-RESULTS	Of these , 1 patient ( 2.2 % ) developed temporary complete heart block .
-RESULTS	No adverse events were identified in the control group of 154 patients who received dobutamine without atropine .
-CONCLUSIONS	Our findings suggest that complete heart block can occur infrequently with the administration of atropine in heart transplant patients undergoing DSE .
-CONCLUSIONS	Therefore , patients should be appropriately monitored for these adverse events during and after DSE .
-
-###25378376
-BACKGROUND	Efficacy of intravenous ( IV ) volume expansion in preventing contrast-induced acute kidney injury ( CI-AKI ) is well known .
-BACKGROUND	However , the role of oral hydration has not been well established .
-BACKGROUND	The aim of this work was to evaluate the efficacy of oral hydration in preventing CI-AKI .
-METHODS	We prospectively randomized 225 patients undergoing coronary angiography and/or percutaneous coronary intervention in either oral hydration or IV hydration groups .
-METHODS	Patients who have at least one of the high-risk factors for developing CI-AKI ( advanced age , type 2 diabetes mellitus , anemia , hyperuricemia , a history of cardiac failure or systolic dysfunction ) were included in the study .
-METHODS	All patients had normal renal function or stage 1-2 chronic kidney disease .
-METHODS	Patients in the oral hydration group were encouraged to drink unrestricted amounts of fluids freely whereas isotonic saline infusion was performed by the standard protocol in the IV hydration group .
-RESULTS	CI-AKI occurred in 8/116 patients ( 6.9 % ) in the oral hydration group and 8/109 patients ( 7.3 % ) in the IV hydration group ( p = 0.89 ) .
-RESULTS	There was also no statistically significant difference between the two groups when different CI-AKI definitions were taken into account .
-CONCLUSIONS	Oral hydration is as effective as IV hydration in preventing CI-AKI in patients with normal kidney function or stage 1-2 chronic kidney disease , and who also have at least one of the other high-risk factors for developing CI-AKI .
-
-###25712802
-OBJECTIVE	Motor imagery ( MI ) is assumed to enhance poststroke motor recovery , yet its benefits are debatable .
-OBJECTIVE	Brain-computer interfaces ( BCIs ) can provide instantaneous and quantitative measure of cerebral functions modulated by MI .
-OBJECTIVE	The efficacy of BCI-monitored MI practice as add-on intervention to usual rehabilitation care was evaluated in a randomized controlled pilot study in subacute stroke patients .
-METHODS	Twenty-eight hospitalized subacute stroke patients with severe motor deficits were randomized into 2 intervention groups : 1-month BCI-supported MI training ( BCI group , n = 14 ) and 1-month MI training without BCI support ( control group ; n = 14 ) .
-METHODS	Functional and neurophysiological assessments were performed before and after the interventions , including evaluation of the upper limbs by Fugl-Meyer Assessment ( FMA ; primary outcome measure ) and analysis of oscillatory activity and connectivity at rest , based on high-density electroencephalographic ( EEG ) recordings .
-RESULTS	Better functional outcome was observed in the BCI group , including a significantly higher probability of achieving a clinically relevant increase in the FMA score ( p < 0.03 ) .
-RESULTS	Post-BCI training changes in EEG sensorimotor power spectra ( ie , stronger desynchronization in the alpha and beta bands ) occurred with greater involvement of the ipsilesional hemisphere in response to MI of the paralyzed trained hand .
-RESULTS	Also , FMA improvements ( effectiveness of FMA ) correlated with the changes ( ie , post-training increase ) at rest in ipsilesional intrahemispheric connectivity in the same bands ( p < 0.05 ) .
-CONCLUSIONS	The introduction of BCI technology in assisting MI practice demonstrates the rehabilitative potential of MI , contributing to significantly better motor functional outcomes in subacute stroke patients with severe motor impairments .
-
-###25527661
-BACKGROUND	Adequate maternal dietary protein intake is necessary for healthy pregnancy .
-BACKGROUND	However , current protein intake recommendations for healthy pregnant women are based on factorial calculations of nitrogen balance data derived from nonpregnant adults .
-BACKGROUND	Thus , an estimate of protein requirements based on pregnancy-specific data is needed .
-OBJECTIVE	The objective of this study was to determine protein requirements of healthy pregnant women at 11-20 ( early ) and 31-38 ( late ) wk of gestation through use of the indicator amino acid oxidation method .
-METHODS	Twenty-nine healthy women ( 24-37 y ) each randomly received a different test protein intake ( range : 0.22-2 .56 g kg ( -1 ) d ( -1 ) ) during each study day in early ( n = 35 observations in 17 women ) and late ( n = 43 observations in 19 women ) gestation ; 7 women participated in both early and late gestation studies .
-METHODS	The diets were isocaloric and provided energy at 1.7 resting energy expenditure .
-METHODS	Protein was given as a crystalline amino acid mixture based on egg protein composition , except phenylalanine and tyrosine , which were maintained constant across intakes .
-METHODS	Protein requirements were determined by measuring the oxidation rate of L - [ 1 - ( 13 ) C ] phenylalanine to ( 13 ) CO2 ( F ( 13 ) CO2 ) .
-METHODS	Breath and urine samples were collected at baseline and isotopic steady state .
-METHODS	Linear regression crossover analysis identified a breakpoint ( requirement ) at minimal F ( 13 ) CO2 in response to different protein intakes .
-RESULTS	The estimated average requirement ( EAR ) for protein in early and late gestation was determined to be 1.22 ( R ( 2 ) = 0.60 ; 95 % CI : 0.79 , 1.66 g kg ( -1 ) d ( -1 ) ) and 1.52 g kg ( -1 ) d ( -1 ) ( R ( 2 ) = 0.63 ; 95 % CI : 1.28 , 1.77 g kg ( -1 ) d ( -1 ) ) , respectively .
-CONCLUSIONS	These estimates are considerably higher than the EAR of 0.88 g kg ( -1 ) d ( -1 ) currently recommended by the Dietary Reference Intakes .
-CONCLUSIONS	To our knowledge , this study is the first to directly estimate gestational stage-specific protein requirements in healthy pregnant women and suggests that current recommendations based on factorial calculations underestimate requirements .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01784198 .
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-###24345356
-OBJECTIVE	To evaluate the impact of concurrent treatments for substance use disorder and nicotine-dependence for stimulant-dependent patients .
-METHODS	A randomized , 10-week trial with follow-up at 3 and 6 months after smoking quit date conducted at 12 substance use disorder treatment programs between February 2010 and July 2012 .
-METHODS	Adults meeting DSM-IV-TR criteria for cocaine and/or methamphetamine dependence and interested in quitting smoking were randomized to treatment as usual ( n = 271 ) or treatment as usual with smoking-cessation treatment ( n = 267 ) .
-METHODS	All participants received treatment as usual for substance use disorder treatment .
-METHODS	Participants assigned to treatment as usual with concurrent smoking-cessation treatment received weekly individual smoking cessation counseling and extended-release bupropion ( 300 mg/d ) during weeks 1-10 .
-METHODS	During post-quit treatment ( weeks 4-10 ) , participants assigned to treatment as usual with smoking-cessation treatment received a nicotine inhaler and contingency management for smoking abstinence .
-METHODS	Weekly proportion of stimulant-abstinent participants during the treatment phase , as assessed by urine drug screens and self-report , was the primary outcome .
-METHODS	Secondary measures included other substance/nicotine use outcomes and treatment attendance .
-RESULTS	There were no significant treatment effects on stimulant-use outcomes , as measured by the primary outcome and stimulant-free days , on drug-abstinence , or on attendance .
-RESULTS	Participants assigned to treatment as usual with smoking-cessation treatment , relative to those assigned to treatment as usual , had significantly better outcomes for drug-free days at 6-month follow-up ( ( 2 ) ( 1 ) = 4.09 , P < .05 ) , with a decrease in drug-free days from baseline of -1.3 % in treatment as usual with smoking-cessation treatment and of -7.6 % in treatment as usual .
-RESULTS	Participants receiving treatment as usual with smoking-cessation treatment , relative to those receiving treatment as usual , had significantly better outcomes on smoking point-prevalence abstinence ( 25.5 % vs 2.2 % ; ( 2 ) ( 1 ) = 44.69 , P < .001 ; OR = 18.2 ) .
-CONCLUSIONS	These results suggest that providing smoking-cessation treatment to illicit stimulant-dependent patients in outpatient substance use disorder treatment will not worsen , and may enhance , abstinence from nonnicotine substance use .
-BACKGROUND	ClinicalTrials.gov identifier : NCT01077024 .
-
-###24721597
-BACKGROUND	High tibial osteotomy is a common procedure to treat symptomatic osteoarthritis of the medial compartment of the knee with varus alignment .
-BACKGROUND	This is achieved by overcorrecting the varus alignment to 2-6 of valgus .
-BACKGROUND	Various high tibial osteotomy techniques are currently used to this end .
-BACKGROUND	Common procedures are medial opening wedge and lateral closing wedge tibial osteotomies .
-BACKGROUND	The lateral closing wedge technique is a primary stable correction with a high rate of consolidation , but has the disadvantage of bone loss and change in tibial condylar offset .
-BACKGROUND	The medial opening wedge technique does not result in any bone loss but needs to be fixated with a plate and may cause tibial slope and medial collateral ligament tightening .
-BACKGROUND	A relatively new technique , the combined valgus high tibial osteotomy , claims to include the advantages of both techniques without bone loss .
-BACKGROUND	Aim of this prospective randomized trial is to compare the lateral closing wedge with the combined wedge osteotomy in patients with symptomatic varus osteoarthritis of the knee .
-METHODS	A group of 110 patients with osteoarthritis of the medial compartment of the knee with 6-12 varus malalignment over 18 years of age are recruited to participate a randomized controlled trial .
-METHODS	Patients are randomized to undergo a high tibial osteotomy , with either a lateral closing wedge technique or a combined wedge osteotomy technique .
-METHODS	Primary outcome measure is achievement of an overcorrection of 4 valgus after one year of surgery , assessed by measuring the hip-knee-ankle angle .
-METHODS	Secondary objectives are radiological scores and anatomical changes after high tibial osteotomy ; pain , functional scores and quality of life will also be compared .
-CONCLUSIONS	Combined high tibial osteotomy modification avoids metaphyseal tibial bone loss , decreasing transposition of the tibial condyle and shortening of the patellar tendon after osteotomy , even in case of great correction .
-CONCLUSIONS	The clinical results of the combined wedge osteotomy technique are very promising .
-CONCLUSIONS	Hypothesis is that the combined wedge osteotomy technique will achieve more accurate overcorrection of varus malalignment with fewer anatomical changes of the proximal tibia after one year .
-BACKGROUND	Dutch Trial Registry ( Netherlands trial register ) : NTR3898 .
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-###25452097
-OBJECTIVE	To prospectively evaluate the effect of listening to music and inhaling aroma oil on patients undergoing screening computed tomography colonography .
-METHODS	Two hundred and twenty four participants were randomly allocated to one of the four groups including : ( 1 ) combined music and aroma , ( 2 ) music alone , ( 3 ) aroma alone , and ( 4 ) control .
-METHODS	The visual analog scale for pain and a questionnaire were used for subjective outcomes .
-METHODS	We also used a pre-testpost-test design to compare the differences in blood pressure and heart rate as objective outcomes .
-RESULTS	There were no statistical differences between the control group and other groups in the visual analog scale or changes in heart rate .
-RESULTS	Changes in blood pressure were similar .
-RESULTS	Participants reported good overall experiences .
-RESULTS	There were no differences in terms of overall satisfaction , pain rating , willingness to repeat the computed tomography colonography procedure in the future , or preference between colonoscopy and computed tomography colonography .
-RESULTS	More participants using music and/or aroma requested music and/or aroma during the next computed tomography colonography ( P < 0.0001 ) .
-CONCLUSIONS	Although audio and olfactory intervention had little effect on perceived pain or discomfort and vital signs , participants who listened to music and inhaled aroma during the computed tomography colonography preferred music and aroma during the next computed tomography colonography .
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-###24512656
-OBJECTIVE	To evaluate the effect of the dimensions of the uterine cavity in relation to the expulsion , or removal for displacement , of intrauterine devices ( IUDs ) MLCu375 and TCu380A .
-METHODS	A case-control study nested in a multicentre clinical trial .
-METHODS	Eighteen family planning clinics in China .
-METHODS	Forty-eight pairs of TCu380A users and 118 pairs of MLCu375 users .
-METHODS	The women were classified as cases if IUD expulsion or displacement occurred during the first year of follow-up after insertion .
-METHODS	One control was randomly selected for each case matched by IUD model , centre , age , service provider for insertion , and date of insertion .
-METHODS	Axial length of the uterine cavity ( LUC ) and the largest transverse diameter of the coronal section of the uterine cavity ( LTD ) were measured using abdominal ultrasound .
-METHODS	We used multivariate conditional logistic regressions to estimate the adjusted odds ratios ( aORs ) of expulsions or displacements among women with different sizes of uterine cavity according to the quartile of LUC and LTD , respectively .
-RESULTS	Among MLCu375 users , women with LTD 27 mm had a higher risk of expulsion or displacement ( aOR 2.40 ; 95 % confidence interval , 95 % CI , 1.02-5 .63 ) , after adjusting for the volume of menstrual flow , dysmenorrhoea , parity , uterine position , MLCu375 type , and LUC .
-RESULTS	Among TCu380A users , the association between LTD 37 mm and expulsion or displacement ( aOR 4.98 ; 95 % CI 1.01-22 .49 ) was statistically significant , after adjusting for LUC and potential confounding factors .
-CONCLUSIONS	Our study suggests that LTD should be considered when making the decision of which IUD model to use .
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-###25518484
-OBJECTIVE	Analysis of the prevalence of mouth cavity urealytic microflora and determination of the level of its enzymatic activity depending on concentration and amount of urea solution taken as a substrate .
-METHODS	62 randomly chosen patients at the age of 5-64 took part in the study .
-METHODS	Each of them rinsed the mouth with 50 ml of 1 % urea solution .
-METHODS	Before and after rinsing the concentration of ammonia in the mouth cavity air was measured .
-METHODS	In patients with highest and lowest activity of mouth cavity urealytic microflora a series of tests was carried out including mouth rinsing with urea solution in various concentrations and amounts and measuring ammonia concentration before and after rinsing .
-METHODS	Obtained results were analyzed using mathematical statistics methods .
-RESULTS	It was found that in 91 % 1.8 % of randomly chosen patients ( p < 0.05 ) mouth cavity microflora showed apparent urease activity .
-RESULTS	The lowest concentration ( 0.0625 % in 50 ml ) and volume ( 0.5 ml of 1 % solution ) levels of urea solution were obtained that can exert negative influence on the results of helicobacteriosis diagnosis by means of mouth cavity air analysis .
-CONCLUSIONS	Urealytic microflora in the mouth cavity is very common and may constitute a factor that decreases the specificity of helicobacteriosis diagnosis by means of the methods based on detection of indicators of gas metabolites resulting from the enzymatic reaction in air samples taken from the mouth cavity after oral administration of urea .
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-###25318780
-BACKGROUND	Robotic guidance has been shown to facilitate motor skill acquisition , through altered sensorimotor control , in neurologically impaired and healthy populations .
-OBJECTIVE	To determine if robot-guided practice and online visual feedback availability primarily influences movement planning or online control mechanisms .
-METHODS	In this two-experiment study , participants first performed a pre-test involving reaches with or without vision , to obtain baseline measures .
-METHODS	In both experiments , participants then underwent an acquisition phase where they either actively followed robot-guided trajectories or trained unassisted .
-METHODS	Only in the second experiment , robot-guided or unassisted acquisition was performed either with or without online vision .
-METHODS	Following acquisition , all participants completed a post-test that was the same as the pre-test .
-METHODS	Planning and online control mechanisms were assessed through endpoint error and kinematic analyses .
-RESULTS	The robot-guided and unassisted groups generally exhibited comparable changes in endpoint accuracy and precision .
-RESULTS	Kinematic analyses revealed that only participants who practiced with the robot exhibited significantly reduced the proportion of movement time spent during the limb deceleration phase ( i.e. , time after peak velocity ) .
-RESULTS	This was true regardless of online visual feedback availability during training .
-CONCLUSIONS	The influence of robot-assisted motor skill acquisition is best explained by improved motor planning processes .
-
-###25354554
-OBJECTIVE	RAD51 , a central player in the response to DNA damage , has been suspected to contribute to tumour resistance to therapy .
-OBJECTIVE	A single-nucleotide polymorphism , RAD51 135G > C , in the untranslated region of the RAD51 gene elevates breast cancer risk among BRCA2 carriers .
-OBJECTIVE	In this study , it was investigated whether this polymorphism is related to prognosis of breast cancer and RAD51 protein expression and whether it is indicative of resistance to radiotherapy or cyclophosphamide/methotrexate/5-fluorouracil ( CMF ) chemotherapy .
-METHODS	We genotyped 306 patients with early breast cancer , who were randomised to receive post-operative radiotherapy or CMF chemotherapy , for the RAD51 135G > C polymorphism .
-METHODS	RAD51 protein expression was evaluated with immunohistochemistry .
-RESULTS	15.4 % of the patients had at least one C-allele ( three were C homozygotes ) .
-RESULTS	There was no correlation between genotype and protein expression .
-RESULTS	Patients who were G homozygotes benefitted from radiotherapy with decreased risk of local recurrences ( RR = 0.32 , 95 % C.I. 0.16-0 .64 , p = 0.001 ) .
-RESULTS	CMF chemotherapy reduced the risk of distant recurrence for patients carrying at least one C-allele ( RR = 0.29 , 95 % C.I. 0.10-0 .88 , p = 0.03 ) , whereas G homozygotes had no benefit from chemotherapy .
-RESULTS	There was a significant interaction between chemotherapy and genotype ( p = 0.02 ) .
-CONCLUSIONS	The results suggest that the RAD51 135G > C polymorphism predicts CMF chemotherapy effect in early breast cancer .
-
-###24895381
-OBJECTIVE	To evaluate the effects of a 12-week balance training programme on self-assessed function and disability in healthy community-dwelling older adults with self-perceived balance deficits and fear of falling .
-METHODS	A prospective , randomized controlled trial .
-METHODS	Stockholm County , Sweden .
-METHODS	A total of 59 community-dwelling older adults ( 42 women and 17 men ) aged 67-93 were randomized to either an intervention group ( n = 38 ) or to serve as controls ( n = 21 ) after baseline testing .
-METHODS	The intervention was a 12-week , three times per week , progressive , specific and individually adjusted group balance-training programme .
-METHODS	Self-perceived function and disability measured with Late Life Function and Disability Instrument .
-RESULTS	The intervention group reported improvement in overall function ( p = 0.016 ) , as well as in basic ( p = 0.044 ) and advanced lower extremity function ( p = 0.025 ) compared with the control group .
-RESULTS	The study showed no improvement in overall disability or upper extremity function .
-CONCLUSIONS	This group balance training programme improves self-assessed function in community-dwelling older adults with balance deficits and fear of falling .
-
-###25518300
-OBJECTIVE	To evaluate the impact on ovarian reserve between two different methods ofhemostasis after laparoscopic ovarian endometrioma excision .
-METHODS	A randomized controlled study was conducted from January to December 2013 in Thammasat University Hospital , Thailand .
-METHODS	Reproductive women , age 18-45years who underwent laparoscopic ovarian cystectomy were randomized in electrocoagulation and suture groups .
-METHODS	Clinical baseline data and ovarian reserve outcome ( anti-Mullerian hormone ( AMH ) ) were evaluated .
-RESULTS	Fifty participants were recruited and randomized in two groups .
-RESULTS	Electrocoagulation and suture groups consisted of 25 participants .
-RESULTS	Baseline characteristics between 2 groups ( age , weight , BMI , height , cyst diameter , duration and estimated blood loss ) were not statistically different .
-RESULTS	There were no significant difference of AMIH between electrocoagulation and suture group atpre-operative ( 2.902.26 vs. 2.522.37 ng/ml ) , 1 week ( 1.781.51 vs. 1.991.71 ng/ml ) , 1 month ( 1.761.50 vs. 2.091.62 ng/ml ) , 3 months ( 2.091.66 vs. 1.961.68 ng/ml ) and 6 months ( 2.111.84 vs 1.721.68 ng/ml ) , respectively .
-RESULTS	However mean AMH ofboth groups significantly decreased since the first week of operation .
-RESULTS	Effect oflaparoscopic ovarian surgery had significantly declined and sustained AMH level until 6 months .
-CONCLUSIONS	Laparoscopic cystectomy of ovarian endometrioma has negative impact to ovarian reserve .
-CONCLUSIONS	Either electroco - agulation or suture method had no different effects .
-
-###24797121
-BACKGROUND	Implicit learning of intraoperative auditory stimuli during general anesthesia is very difficult to quantify but may require the presence of noxious stimulation .
-BACKGROUND	We hypothesized that an anesthetic regimen with a low dose of opioid would enhance implicit memory , while a regimen with a high dose of opioid would not .
-METHODS	One hundred-twenty patients were randomized into 3 groups .
-METHODS	All patients were anesthetized with a target-controlled infusion of propofol and remifentanil , targeting a Bispectral Index ( BIS ) value of 50 .
-METHODS	The remifentanil effect-site concentration ( in ng/mL ) was always double that of propofol ( in g/mL ) in the first group and half of that in the second group .
-METHODS	Patients in these 2 groups were played a list of 20 words via headphones during surgery .
-METHODS	The third group served as control for memory tests and was not played any word during anesthesia .
-METHODS	BIS was recorded during word presentation .
-RESULTS	No statistical difference was found among the 3 groups regarding 3 different memory tests although 67.5 % [ 50.7 % ; 80.9 % ] of the patients of the high-opioid group and 72.5 % [ 55.9 % ; 84.9 % ] of the low-opioid group had at least 1 episode of BIS > 60 .
-CONCLUSIONS	We could not demonstrate the presence of implicit or explicit memorization under propofol-remifentanil anesthesia either with a low - or a high-dose opioid anesthetic regimen .
-
-###24911964
-OBJECTIVE	The mechanisms by which a ` Mediterranean diet ' reduces cardiovascular disease ( CVD ) burden remain poorly understood .
-OBJECTIVE	Lycopene is a potent antioxidant found in such diets with evidence suggesting beneficial effects .
-OBJECTIVE	We wished to investigate the effects of lycopene on the vasculature in CVD patients and separately , in healthy volunteers ( HV ) .
-RESULTS	We randomised 36 statin treated CVD patients and 36 healthy volunteers in a 21 treatment allocation ratio to either 7 mg lycopene or placebo daily for 2 months in a double-blind trial .
-RESULTS	Forearm responses to intra-arterial infusions of acetylcholine ( endothelium-dependent vasodilatation ; EDV ) , sodium nitroprusside ( endothelium-independent vasodilatation ; EIDV ) , and NG-monomethyl-L-arginine ( basal nitric oxide ( NO ) synthase activity ) were measured using venous plethysmography .
-RESULTS	A range of vascular and biochemical secondary endpoints were also explored .
-RESULTS	EDV in CVD patients post-lycopene improved by 53 % ( 95 % CI : +9 % to +93 % , P = 0.03 vs. placebo ) without changes to EIDV , or basal NO responses .
-RESULTS	HVs did not show changes in EDV after lycopene treatment .
-RESULTS	Blood pressure , arterial stiffness , lipids and hsCRP levels were unchanged for lycopene vs. placebo treatment groups in the CVD arm as well as the HV arm .
-RESULTS	At baseline , CVD patients had impaired EDV compared with HV ( 30 % lower ; 95 % CI : -45 % to -10 % , P = 0.008 ) , despite lower LDL cholesterol ( 1.2 mmol/L lower , 95 % CI : -1.6 to -0.9 mmol/L , P < 0.001 ) .
-RESULTS	Post-therapy EDV responses for lycopene-treated CVD patients were similar to HVs at baseline ( 2 % lower , 95 % CI : -30 % to +30 % , P = 0.85 ) , also suggesting lycopene improved endothelial function .
-CONCLUSIONS	Lycopene supplementation improves endothelial function in CVD patients on optimal secondary prevention , but not in HVs .
-BACKGROUND	ClinicalTrials.gov NCT01100385 .
-
-###25225424
-OBJECTIVE	The optimal regimen to prevent chemotherapy-induced nausea and vomiting ( CINV ) for patients undergoing high-dose chemotherapy and autologous stem-cell transplantation ( ASCT ) is unclear .
-OBJECTIVE	To evaluate the effect of aprepitant in addition to a standard regimen , we conducted this randomized , placebo-controlled phase III trial .
-METHODS	Patients with multiple myeloma were randomly assigned at a one-to-one ratio to receive either aprepitant ( 125 mg orally on day 1 and 80 mg orally on days 2 to 4 ) , granisetron ( 2 mg orally on days 1 to 4 ) , and dexamethasone ( 4 mg orally on day 1 and 2 mg orally on days 2 to 3 ) or matching placebo , granisetron ( 2 mg orally on days 1 to 4 ) , and dexamethasone ( 8 mg orally on day 1 and 4 mg orally on days 2 to 3 ) .
-METHODS	Melphalan 100 mg/m ( 2 ) was administered intravenously on days 1 to 2 .
-METHODS	ASCT was performed on day 4 .
-METHODS	The primary end point ( complete response ) was defined as no emesis and no rescue therapy within 120 hours of melphalan administration .
-METHODS	Quality of life was assessed by modified Functional Living Index-Emesis ( FLIE ) questionnaire on days -1 and 6 .
-RESULTS	Overall , 362 patients were available for the efficacy analysis ( 181 in each treatment arm ) .
-RESULTS	Significantly more patients receiving aprepitant reached the primary end point ( 58 % v 41 % ; odds ratio [ OR ] , 1.92 ; 95 % CI , 1.23 to 3.00 ; P = .0042 ) .
-RESULTS	Absence of major nausea ( 94 % v 88 % ; OR , 2.37 ; 95 % CI , 1.09 to 5.15 ; P = .026 ) and emesis ( 78 % v 65 % ; OR , 1.99 ; 95 % CI , 1.25 to 3.18 ; P = .0036 ) within 120 hours was increased by aprepitant .
-RESULTS	Mean total FLIE score ( standard deviation ) was 114 18 for aprepitant and 106 26 for placebo ( P < .001 ) .
-CONCLUSIONS	The addition of aprepitant resulted in significantly less CINV and had a positive effect on quality of life .
-
-###25030327
-OBJECTIVE	This study compared transobturator tension-free vaginal tape ( TVT-O ) and Contasure-Needleless ( C-NDL ) at long-term follow-up .
-METHODS	Non-inferiority , prospective , single-centre , quasi-randomised trial started in September 2006 and finished in April 2011 to compare C-NDL with transobturator vaginal tape ( TVT-O ) mesh in the treatment of stress urinary incontinence ( SUI ) .
-METHODS	Epidemiological information , intraoperative and postoperative complications , subjective estimates of blood loss and pain levels were recorded .
-METHODS	We also analysed the postoperative stress test , the subjective impression of improvement using the Sandvik Severity Index and the quality of life during follow-up using the International Consultation on Incontinence Questionnaire-Short Form ( ICIQ-SF ) .
-RESULTS	Two hundred and fifty-seven women with primary SUI were scheduled to receive TVT-O or C-NDL and were followed up at least 3 years after the procedure .
-RESULTS	One hundred and eleven women in the C-NDL group ( 84.7 % ) had a negative stress test , compared with 54 women ( 88.9 % ) in the TVT-O group ( p = 0.0065 for the non-inferiority test ) .
-RESULTS	The postoperative Sandvik Severity Index was 0 or better than the preoperative score in 90.7 % of patients in the C-NDL group and 95.4 % of patients in the TVT-O group ( p = 0.0022 ) .
-RESULTS	The complication rate was similar in both groups .
-RESULTS	There were significant differences ( p = 0.02 ) in postoperative pain within the TVT-O group .
-RESULTS	The degree of satisfaction was not statistically significant between the two groups .
-CONCLUSIONS	The outcomes for the C-NDL group were similar to those of the TVT-O group , adding the concept of `` single incision tape '' to the tension-free sling option .
-
-###25015519
-BACKGROUND	Routine drainage of the abdominal cavity after surgery has been a robust dogma for many decades .
-BACKGROUND	Nevertheless , the policy of routine abdominal drainage is increasingly questioned .
-BACKGROUND	Many surgeons believe that routine drainage after surgery may prevent postoperative intra-abdominal infection .
-BACKGROUND	The goal of this study was to assess the role of drains in laparoscopic cholecystectomy ( LC ) for acute cholecystitis .
-METHODS	From May 2008 to July 2012 , 160 patients that underwent LC due to acute cholecystitis at Gangnam Severance Hospital , Yonsei University Health System , Seoul , Korea , were enrolled in this study .
-METHODS	After surgery , patients were randomly allocated to undergo drain placement in the subhepatic space ( Group A ) or no drainage ( Group B ) .
-RESULTS	There was no significant difference in the intra-abdominal abscess rate , which was 0.0 % with Group A and 1.3 % with Group B ( P = 0.319 ) .
-RESULTS	The median subhepatic fluid collection was 4.1 mL ( 1.160 mL ) in Group A and 4.5 mL ( 1.180.0 mL ) in Group B ( P = 0.298 ) .
-RESULTS	However , the median hospital stay was 2 days ( 14 days ) in Group B and 3 days ( 27 days ) in group A ( P = 0.001 ) .
-RESULTS	The subgroup of empyema patients did not have any significant differences in intra-abdominal fluid collection or intra-abdominal abscess rate .
-CONCLUSIONS	This study suggests that postoperative routine drainage of the abdominal cavity for acute cholecystitis does not prevent intra-abdominal infections .
-
-###24535888
-OBJECTIVE	Fexinidazole is a 5-nitroimidazole recently included in a clinical efficacy trial as an oral drug for the treatment of human African trypanosomiasis ( HAT ) .
-OBJECTIVE	Preclinical studies showed it acts as a pharmacologically active pro-drug with two key active metabolites : sulfoxide and sulfone ( the most active metabolite ) .
-OBJECTIVE	The present studies aimed to determine the best dose regimen for the treatment of stage 2 sleeping sickness patients , which could eventually also treat stage 1 patients .
-METHODS	Fexinidazole was assessed in 154 healthy adult male subjects of sub-Saharan African origin .
-METHODS	Three initial first-in-human studies and two additional studies assessed a single ascending dose and multiple ascending doses ( both under fasted conditions ) , tablet versus suspension formulation and food effect ( fasted vs. high-fat meal and field-adapted food ) , and multiple ascending doses with a loading dose regimen under fed conditions .
-RESULTS	Fexinidazole was well-tolerated in a single dose from 100 to 3,600 mg , with quick absorption of the parent drug and rapid metabolism into sulfoxide [ time to maximum concentration ( t max ) 2-5 h ] and sulfone ( t max 18-24 h ) .
-RESULTS	The tablet formulation was approximately 25 % less bioavailable than the suspension , and food intake increased drug absorption and plasma concentrations of fexinidazole and its two metabolites by approximately 200 % .
-RESULTS	Fourteen-day multiple ascending dosing administered up to 3,600 mg/day in fasted conditions showed that fexinidazole was generally well-tolerated ( mild to moderate , spontaneously reversible drug-related adverse events ) .
-RESULTS	Following the high-fat food effect finding , another study was conducted to evaluate the impact of a low-fat regimen closer to that of the target population , showing that the type of meal does not influence fexinidazole absorption .
-RESULTS	The last study showed that a loading dose of 1,800 mg/day for 4 days followed by a 1,200 mg/day regimen for 6 days with a normal meal provided the desired exposure of fexinidazole and its metabolites , particularly sulfone , with good tolerability .
-RESULTS	Based on preclinical evidence from a chronic infection mouse model , systemic drug concentrations obtained are expected to be clinically effective in stage 2 HAT .
-CONCLUSIONS	These studies show that fexinidazole can be safely assessed in patients as a potential oral cure for both stages of HAT .
-
-###25424947
-BACKGROUND	During development of an A/H1N1 pandemic influenza vaccine , this study was performed to identify the antigen and adjuvant content which would provide optimal antibody response and persistence in adults and the elderly .
-BACKGROUND	Dose-sparing strategies , such as inclusion of adjuvants , are critical in ensuring the widest possible population coverage in the event of an influenza pandemic , despite a limited global capacity for vaccine manufacture .
-METHODS	Healthy subjects aged 18-64 years ( n = 1240 ) and 65 years ( n = 1352 ) were vaccinated with 1 of 8 investigational vaccine formulations varying in antigen quantity ( 3.75 g to 30 g of hemagglutinin ) and MF59 ( ) adjuvant ( none , half dose , or full dose ) .
-METHODS	All subjects received 2 vaccine doses administered 3 weeks apart .
-METHODS	Antibody response was assessed by hemagglutination inhibition assay 1 and 3 weeks after administration of first and second doses .
-METHODS	Antibody persistence was assessed after 6 and 12 mo. .
-METHODS	Vaccine safety was monitored over 12 mo. .
-RESULTS	All 8 investigational A/H1N1 vaccine formulations were well tolerated , and rapidly induced high antibody titers which met all of the Center for Biologics Evaluation and Research ( CBER ) and Committee for Medicinal Products for Human Use ( CHMP ) licensure criteria 3 weeks after one dose .
-RESULTS	The highest antibody titers were observed in participants vaccinated with higher quantities of antigen and adjuvant .
-CONCLUSIONS	A single vaccine dose containing 3.75 g of A/California/7 / 2009 ( H1N1 ) antigen with MF59 adjuvant was identified as optimal for young to middle-aged ( 18-64 years ) and older ( 65 years ) adult populations .
-
-###24508634
-OBJECTIVE	We assessed the efficacy and tolerability of onabotulinumtoxinA 200 U vs placebo to treat lower urinary tract symptoms/benign prostatic hyperplasia inmen previously treated with oral benign prostatic hyperplasia medication in a24-week phase 2 , multicenter , double-blind , randomized , placebo controlled , parallel group trial .
-METHODS	Patients with I-PSS ( International Prostate Symptom Score ) 14 or greater , peak urinary flow rate 4 to 15 ml per second and total prostate volume 30 to 80 ml were randomized 1:1 to a single intraprostatic treatment of onabotulinumtoxinA 200 U or placebo .
-METHODS	A single-blind sham procedure followed by a 4-week run-in was included to attempt to minimize any potential placebo effect .
-METHODS	Patients who still met eligibility criteria after the run-in entered the double-blind active treatment period .
-METHODS	The primary end point was the change from baseline in total I-PSS at week 12 .
-METHODS	Other end points assessed at weeks 6 , 12and 24 included the change from baseline in total I-PSS , peak urinary flow rate , total prostate volume and post-void residual urine volume .
-RESULTS	Of 427 patients enrolled 315 were randomized and treated .
-RESULTS	Decreases from baseline in I-PSS were observed in the onabotulinumtoxinA and placebo groups ( -6.3 vs -5.6 points , p < 0.001 ) with no difference between the groups overall or in subgroups .
-RESULTS	Improvement was observed in the peak urinary flow rate , which was significant only at week 6 compared to placebo .
-RESULTS	Improvement was significant at all time points in a patient subgroup on stable concurrent - blockers or 5-reductase inhibitors during the study .
-RESULTS	Adverse events were similar in the 2 treatment groups .
-CONCLUSIONS	OnabotulinumtoxinA 200 U and placebo improved I-PSS and were well tolerated but no between group difference in efficacy was observed .
-
-###26138125
-OBJECTIVE	General anesthesia ( GA ) for endovascular therapy ( EVT ) of acute ischemic stroke may be associated with worse outcomes .
-METHODS	The Interventional Management of Stroke III trial randomized patients within 3 hours of acute ischemic stroke onset to intravenous tissue-type plasminogen activatorEVT .
-METHODS	GA use within 7 hours of stroke onset was recorded per protocol .
-METHODS	Good outcome was defined as 90-day modified Rankin Scale 2 .
-METHODS	A multivariable analysis adjusting for dichotomized National Institutes of Health Stroke Scale ( NIHSS ; 8-19 versus 20 ) , age , and time from onset to groin puncture was performed .
-RESULTS	Four hundred thirty-four patients were randomized to EVT , 269 ( 62 % ) were treated under local anesthesia and 147 ( 33.9 % ) under GA ; 18 ( 4 % ) were undetermined .
-RESULTS	The 2 groups were comparable except for median baseline NIHSS ( 16 local anesthesia versus 18 GA ; P < 0.0001 ) .
-RESULTS	The GA group was less likely to achieve a good outcome ( adjusted relative risk , 0.68 ; confidence interval , 0.52-0 .90 ; P = 0.0056 ) and had increased in-hospital mortality ( adjusted relative risk , 2.84 ; confidence interval , 1.65-4 .91 ; P = 0.0002 ) .
-RESULTS	Those with medically indicated GA had worse outcomes ( adjusted relative risk , 0.49 ; confidence interval , 0.30-0 .81 ; P = 0.005 ) and increased mortality ( relative risk , 3.93 ; confidence interval , 2.18-7 .10 ; P < 0.0001 ) with a trend for higher mortality with routine GA. .
-RESULTS	There was no significant difference in the adjusted risks of subarachnoid hemorrhage ( P = 0.32 ) or symptomatic intracerebral hemorrhage ( P = 0.37 ) .
-CONCLUSIONS	GA was associated with worse neurological outcomes and increased mortality in the EVT arm ; this was primarily true among patients with medical indications for GA. .
-CONCLUSIONS	Relative risk estimates , though not statistically significant , suggest reduced risk for subarachnoid hemorrhage and symptomatic intracerebral hemorrhage under local anesthesia .
-CONCLUSIONS	Although the reasons for these associations are not clear , these data support the use of local anesthesia when possible during EVT .
-BACKGROUND	URL : http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00359424 .
-
-###25112081
-OBJECTIVE	To compare the clinical therapeutic effects differences between acupuncture at Suliao ( GV 25 ) and Shuigou ( GV 26 ) on promoting regain of consciousness from coma in severe craniocerebral injury .
-METHODS	Based on regular emergency treatments of neurosurgery , eighty-two cases of craniocerebral injury who were under stable condition were randomly divided into an observation group ( 42 cases ) and a control group ( 40 cases ) .
-METHODS	Suliao ( GV 25 ) was selected as main aupoint , while Laogong ( PC 8 ) and Yongquan ( KI 1 ) , etc. were selected as adjuvant acupoints and Neiguan ( PC 6 ) , Sanyinjiao ( SP 6 ) , Yifeng ( TE 17 ) and Wangu ( GB 12 ) , etc. were selected as matching acupoints in the observation group where a strong needle manipulation was applied to improve the regain of consciousness .
-METHODS	The main acupoint of Shuigou ( GV 26 ) along with identical adjuvant acupoints and matching acupoints in the observation group were selected in the control group with identical strong needle manipulation .
-METHODS	The treatment was given once a day in both groups , five times per week and ten times were considered as one session .
-METHODS	The immediate clinical symptoms after acupuncture at Suliao ( GV 25 ) and Shuigou ( GV 26 ) were observed as well as Glasgow coma scale ( GCS ) before the treatment , after 45 days and 90 days of treatment to assess the resuscitation time and rate .
-METHODS	Also the clinical efficacy was compared between both groups .
-RESULTS	The occurrence rate of sneezing reflex was 85.7 % ( 36/42 ) in the observation group , which was higher than 25.0 % ( 10/40 ) in the control group ( P < 0.01 ) .
-RESULTS	The average resuscitation time was ( 64.6 + / - 19.4 ) days in the observation group , which was obviously shorter than ( 73.8 + / - 14.6 ) days in the control group ( P < 0.05 ) .
-RESULTS	The resuscitation rate was 88.1 % ( 37/42 ) in the observation group , which was similar to 75.0 % ( 30/40 ) in the control group ( P > 0.05 ) .
-RESULTS	Compared before the treatment , GCS were both improved after the treatment in two groups ( both P < 0.01 ) .
-RESULTS	The 90-day GCS was 9.52 + / - 2.32 in the observation group , which was superior to 8.47 + / -2.14 in the control group ( P < 0.05 ) .
-RESULTS	The curative and markedly effective rate was 45.2 % ( 19/42 ) in the observation group , which was superior to 22.5 % ( 9/40 ) in the control group ( P < 0.05 ) .
-CONCLUSIONS	The effect of acupuncture at Suliao ( GV 25 ) on improving regain of consciousness from coma in severe craniocerebral injury is positive .
-CONCLUSIONS	It could specifically improve sneezing reflex and stimulate respiratory center , which has more obvious effect than acupuncture at Shuigou ( GV 26 ) .
-
-###25733482
-BACKGROUND	Maternal nutritional status is a major determinant of low birth weight and fluctuates across seasons .
-BACKGROUND	Seasonality may influence the outcome of prenatal nutrition interventions that aim to enhance fetal growth .
-OBJECTIVE	This study investigated seasonal modifications of the efficacy of a randomized controlled prenatal nutrition intervention trial in pregnant women to improve fetal growth in rural Burkina Faso .
-METHODS	The second Micronutriments et Sant de la Mre et de l'Enfant study compared a lipid-based nutrient supplement ( LNS ) fortified with multiple micronutrients ( MMNs ) to an MMN supplement .
-METHODS	Truncated Fourier series were used to characterize seasonality in birth outcomes .
-METHODS	Models that included the Fourier series and newborn and maternal characteristics were used to assess seasonal effect modifications of prenatal supplementation on birth outcomes .
-RESULTS	Birth weight , birth length , small for gestational age as a proxy for intrauterine growth retardation , and preterm birth were significantly related to date of birth and showed important seasonal variations .
-RESULTS	LNSs , which supply energy in addition to MMNs , resulted in a significant increase in birth length ( +13.5 mm , 95 % CI : 6.5 , 20.5 mm ) at the transition from rain to dry season ( September to November ) compared to MMNs alone .
-CONCLUSIONS	The climatologic and agricultural seasonal patterns in Burkina Faso affect the efficacy of prenatal LNSs on birth length .
-CONCLUSIONS	In this context , prenatal MMN supplementation programs should be complemented by energy supplementation during the annual rain season to promote fetal growth .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00909974 .
-
-###24377889
-OBJECTIVE	To compare the efficacy of intracoronary administration of combined high-dose adenosine and tirofiban versus intracoronary tirofiban during primary percutaneous coronary intervention ( PCI ) in patients with acute myocardial infarction .
-METHODS	Consecutive 258 patients with acute ST-segment elevation myocardial infarction ( STEMI ) underwent primary PCI , treated with thrombus aspiration and then intracoronary tirofiban , were randomly divided into adenosine group ( n = 130 ) and control group ( n = 128 ) .
-METHODS	Adenosine group received 2 times intracoronary adenosine ( 2 mg ) after thrombus aspiration and after stenting of the infarct-related artery through the aspiration catheter .
-METHODS	Control group received placebo .
-METHODS	The primary end point was myocardial blush grade ( MBG ) after PCI .
-METHODS	Secondary end points were thrombolysis in myocardial infarction ( TIMI ) flow grade and corrected TIMI frame count ( CTFC ) after PCI , ST-segment elevation resolution ( STR ) , and major adverse cardiac events ( MACE ) at 30 days and 12 months .
-RESULTS	TIMI flow grade post PCI did not differ between the 2 groups , while CTFC favored the adenosine-treated patients [ ( 21.6 6.5 ) frames ] compared with the placebo-treated patients [ ( 25.1 7.8 ) frames , P = 0.001 ] .
-RESULTS	MBG 3 was more frequently observed in the adenosine compared to the control group [ 45.1 % ( 55/122 ) vs. 32.0 % ( 39/122 ) , P = 0.035 ] .
-RESULTS	Patients in the adenosine group had a trend of higher rate of compete STR after the procedure compared patients in the control group [ 53.6 % ( 67/125 ) vs. 41.9 % ( 52/124 ) , P = 0.065 ] .
-RESULTS	The incidence of MACE was comparable between patients randomized to adenosine and placebo at 30 days [ 12.3 % ( 16/130 ) vs. 17.2 % ( 22/128 ) , P = 0.295 ] and at 12 months [ 12.3 % ( 16/130 ) vs. 18.0 % ( 23/128 ) , P = 0.227 ] .
-CONCLUSIONS	Intracoronary administration of high-dose adenosine combined with tirofiban provides further improvement on myocardial perfusion after primary PCI but does not affect the clinical outcomes in patients with STEMI .
-
-###25218708
-BACKGROUND	Despite high initial sensitivity to chemotherapy , TNBC is associated with a poor prognosis , highlighting the need for novel therapeutic strategies .
-BACKGROUND	The aim of this multicenter , randomized , open-label phase II trial was to assess the efficacy of ixabepilone as monotherapy , and the combination of ixabepilone with cetuximab , as first-line treatment in patients with triple-negative locally advanced nonresectable and/or metastatic breast cancer .
-METHODS	Women were randomly assigned to receive either ixabepilone ( 40 mg/m ( 2 ) ) every 21 days ( n = 40 ) , or ixabepilone ( 40 mg/m ( 2 ) ) every 21 days with cetuximab ( 400 mg/m ( 2 ) loading dose , followed by 250 mg/m ( 2 ) ) once weekly ( n = 39 ) .
-METHODS	The primary end point of the trial was to estimate the response rates of ixabepilone monotherapy and ixabepilone with cetuximab combination therapy .
-RESULTS	Of 79 randomized patients , 77 were treated .
-RESULTS	Based on an intent-to-treat analysis , an objective response rate of 30 % ( 95 % confidence interval [ CI ] , 16.6-46 .5 ) was observed in the monotherapy arm , and 35.9 % ( 95 % CI , 21.2-52 .8 ) in the combination arm .
-RESULTS	Median progression-free survival was 4.1 months in both treatment groups .
-RESULTS	Safety findings were consistent with the known individual toxicity profiles of ixabepilone and cetuximab .
-RESULTS	Skin and subcutaneous tissue disorders were more common with combination therapy , as were discontinuations because of adverse events .
-CONCLUSIONS	Ixabepilone monotherapy and the ixabepilone and cetuximab combination demonstrated similar levels of clinical activity in first-line treatment of advanced TNBC , with a predictable safety profile .
-CONCLUSIONS	Further investigation of novel therapies for TNBC is required to improve patient outcomes .
-
-###25036524
-BACKGROUND	We previously reported a positive association between serum 25-hydroxyvitamin D ( 25 ( OH ) D ) and colorectal cancer risk .
-BACKGROUND	To further elucidate this association , we examined the molar ratio of 25 ( OH ) D to vitamin D binding protein ( DBP ) , the primary 25 ( OH ) D transport protein , and whether DBP modified the association between 25 ( OH ) D and colorectal cancer risk .
-METHODS	In a nested case-control study within the Alpha-Tocopherol , Beta-Carotene Cancer Prevention Study , controls were 11 matched to 416 colorectal cancer cases based on age and date of blood collection .
-METHODS	Logistic regression was used to estimate odds ratios ( ORs ) and 95 % confidence intervals ( CI ) for quartiles of 25 ( OH ) D , DBP , and the molar ratio of 25 ( OH ) D : DBP , a proxy for free , unbound circulating 25 ( OH ) D.
-RESULTS	Comparing highest to lowest quartiles , DBP was not associated with colorectal cancer risk ( OR = 0.91 ; 95 % CI : 0.58 , 1.42 , p for trend = 0.58 ) ; however , a positive risk association was observed for the molar ratio of 25 ( OH ) D : DBP ( OR = 1.44 ; 95 % CI : 0.92 , 2.26 , p for trend = 0.04 ) .
-RESULTS	In stratified analyses , the positive association between 25 ( OH ) D and colorectal cancer was stronger among men with DBP levels above the median ( OR = 1.89 ; 95 % CI : 1.07 , 3.36 , p for trend = 0.01 ) than below the median ( OR = 1.20 ; 95 % CI : 0.68 , 2.12 , p for trend = 0.87 ) , although the interaction was not statistically significant ( p for interaction = 0.24 ) .
-CONCLUSIONS	Circulating DBP may influence the association between 25 ( OH ) D and colorectal cancer in male smokers , with the suggestion of a stronger positive association in men with higher DBP concentrations .
-CONCLUSIONS	This finding should be examined in other populations , especially those that include women and non-smokers .
-
-###24422876
-BACKGROUND	Osteoporosis and vertebral fracture can have a considerable impact on an individual 's quality of life .
-BACKGROUND	There is increasing evidence that physiotherapy including manual techniques and exercise interventions may have an important treatment role .
-BACKGROUND	This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of two different physiotherapy approaches for people with osteoporosis and vertebral fracture , in comparison to usual care .
-METHODS	Six hundred people with osteoporosis and a clinically diagnosed vertebral fracture will be recruited and randomly allocated to one of three management strategies , usual care ( control - A ) , an exercise-based physiotherapy intervention ( B ) or a manual therapy-based physiotherapy intervention ( C ) .
-METHODS	Those in the usual care arm will receive a single session of education and advice , those in the active treatment arms ( B+C ) will be offered seven individual physiotherapy sessions over 12 weeks .
-METHODS	The trial is designed as a prospective , adaptive single-blinded randomised controlled trial .
-METHODS	An interim analysis will be completed and if one intervention is clearly superior the trial will be adapted at this point to continue with just one intervention and the control .
-METHODS	The primary outcomes are quality of life measured by the disease specific QUALLEFO 41 and the Timed Loaded Standing test measured at 1 year .
-CONCLUSIONS	There are a variety of different physiotherapy packages used to treat patients with osteoporotic vertebral fracture .
-CONCLUSIONS	At present , the indication for each different therapy is not well defined , and the effectiveness of different modalities is unknown .
-BACKGROUND	Reference number ISRCTN49117867 .
-
-###24445723
-OBJECTIVE	The aim of the study was to measure the effects on blood pressure ( BP ) of the angiotensin receptor blocker azilsartan medoxomil , in 40 and 80 mg doses , combined with 5 mg of the calcium channel blocker amlodipine and to compare these effects with placebo plus amlodipine 5 mg .
-METHODS	This was a randomized , controlled , double-blind study of 6 weeks ' duration in 566 patients with stage 2 hypertension .
-METHODS	The primary endpoint was 24-h systolic BP by ambulatory monitoring .
-RESULTS	The mean age of the participants was 58 years ; men and women were equally represented , and baseline 24-h BP ( 153-154/93 mmHg ) and clinic BP ( 165-166/94 -95 mmHg ) were similar across the three treatment groups .
-RESULTS	After 6 weeks , 24-h BP decreased by 25/15 mmHg in both the azilsartan medoxomil/amlodipine 40/5 and 80/5 mg groups .
-RESULTS	These reductions were each greater than the 14/8 mmHg decrease with placebo plus amlodipine 5 mg ( P0 .001 for both comparisons ) .
-RESULTS	All treatments were well tolerated , and adverse events did not increase with the azilsartan medoxomil doses .
-RESULTS	Edema or fluid retention was less common in both combination groups ( 2.6 and 2.7 % ) than with placebo plus amlodipine ( 7.6 % ) .
-CONCLUSIONS	Coadministration of azilsartan medoxomil with amlodipine was well tolerated and led to meaningful additional BP reductions compared with placebo plus amlodipine .
-
-###24370249
-OBJECTIVE	To determine whether increasing the viscosity of a standard hemoglobin-based oxygen-carrying solution ( HBOC ) would offset its associated vasoconstrictive effects and result in improved microvascular perfusion in healthy splenectomized dogs with experimentally induced hemorrhagic shock .
-METHODS	12 male American Foxhounds .
-METHODS	Each dog underwent anesthesia and splenectomy .
-METHODS	Shock was induced by controlled hemorrhage until a mean arterial blood pressure of 40 mm Hg was achieved and maintained for 60 minutes .
-METHODS	Dogs were then randomly assigned to receive either a standard or hyperviscous HBOC ( 6 dogs/group ) .
-METHODS	Sidestream dark-field microscopy was used to assess the effects of shock and HBOC administration on the microcirculation of the buccal mucosa and the jejunal serosa .
-METHODS	Video recordings of the microcirculation were collected before shock was induced ( baseline ) and at intervals up to 180 minutes following HBOC administration .
-METHODS	Vascular analysis software was used to compute microcirculatory variables .
-RESULTS	Compared with baseline findings , hemorrhagic shock resulted in decreases in all microvascular variables in the buccal mucosa and the jejunal serosa .
-RESULTS	At all time points following HBOC administration , microvascular variables were similar to initial values and no significant differences between treatment groups were detected .
-RESULTS	At all time points following HBOC administration , blood and plasma viscosities in dogs treated with the hyperviscous solution were significantly higher than values in dogs receiving the standard solution .
-CONCLUSIONS	In splenectomized dogs with experimentally induced hemorrhagic shock , administration of a hyperviscous HBOC did not significantly affect microvascular variables , compared with effects of a standard HBOC .
-CONCLUSIONS	Microcirculatory flow returned to baseline values in both treatment groups , suggesting that marked HBOC-associated vasoconstriction did not occur .
-
-###24830742
-BACKGROUND	Intraventricular fibrinolysis ( IVF ) through bilateral external ventricular drains ( EVD ) may provide better access of the thrombolytic agent to the intraventricular clot , potentially leading to faster clot clearance .
-OBJECTIVE	To compare the feasibility and safety between single and bilateral EVD groups .
-METHODS	Patients with spontaneous intraventricular haemorrhage ( IVH ) ( Graeb score5 ) were treated with IVF .
-METHODS	The selection for placement of one or two EVDs was randomized .
-METHODS	The average daily CSF drainage volume , the indwelling EVD time , the time for monitoring in intensive care unit ( ICU ) , intracranial re-haemorrhage and intracranial infection , Glasgow coma score ( GCS ) , Graeb score and the reserved IVH volume have been analysed for patients with one ( group I , n = 22 ) or two EVDs ( group II , n = 25 ) .
-RESULTS	Significant difference was found in the average daily CSF drainage volume between the two groups ( 85.2 ( SD = 13.7 ) vs. 108.5 ( 15.9 ) ml ) .
-RESULTS	No difference was found in the indwelling EVD time , the time for monitoring in the ICU .
-RESULTS	Through repeated measurements of the variance analysis , the test for a difference in IVH volume over time was statistically significant ( F = 466.981 , p = 0.000 ) and the test for the interaction between treatment and time was also significant ( F = 5.033 , p = 0.002 ) , indicating that the IVH volume decreased over time in both groups , with a sharper decrease in Group II .
-RESULTS	Intracranial re-haemorrhage and infection was not found in this study .
-CONCLUSIONS	The results provide some evidence to support the use of bilateral EVDs for IVF in patients with severe IVH .
-
-###24830937
-OBJECTIVE	We undertook this study to determine the efficacy of oral magnesium supplementation in the improvement of the metabolic profile and blood pressure in metabolically obese , normal-weight ( MONW ) individuals .
-METHODS	A total of 47 MONW individuals with hypomagnesemia were enrolled in clinical a randomized double-blind placebo-controlled trial .
-METHODS	Individuals in the intervention group received 30 mL of MgCl2 5 % solution ( equivalent to 382 mg of magnesium ) and individuals in the control group 30 mL of placebo solution , once daily during 4 months .
-METHODS	In the absence of obesity or overweight , the presence of fasting glucose levels 100 mg/dL , HOMA-IR index 3 , triglyceride levels 150 mg/dL and/or systolic and diastolic blood pressure 140 and 90 mmHg defined the presence of the MONW phenotype .
-METHODS	Hypomagnesemia was defined by serum magnesium concentration 1.8 mg/dL .
-RESULTS	At basal conditions there were no significant differences between groups .
-RESULTS	At the end of follow-up , changes in the mean of systolic ( -2.1 vs. 3.9 % mmHg , p < 0.05 ) and diastolic ( -3.8 vs. 7.5 % mmHg , p < 0.05 ) blood pressures , HOMA-IR index ( -46.5 vs. -5.4 % , p < 0.0001 ) , fasting glucose ( -12.3 vs. -1.8 % mg/dL , p < 0.05 ) and triglyceride levels ( -47.4 % vs. 10.1 % mg/dL , p < 0.0001 ) were significantly lower in the subjects who received MgCl2 compared with individuals in the control group .
-CONCLUSIONS	Oral magnesium supplementation improves the metabolic profile and blood pressure of MONW individuals .
-
-###25042159
-BACKGROUND	Tablets are a novel line of computers controlled by a multitouch screen .
-BACKGROUND	Fine motor movements are captured on the tablet computer through electrical fields and can be qualitatively and quantitatively assessed .
-BACKGROUND	Evidence is limited on tablet use for stroke rehabilitation .
-METHODS	iHOME is an investigator-initiated randomized controlled pilot trial with a single-blinded outcome assessment .
-METHODS	The intervention consists of iPad use ( investigational group ) vs. usual care ( control group ) among patients receiving conventional outpatient rehabilitation .
-METHODS	Eligibility includes aged 18-85 years who experienced a mild ischemic or hemorrhagic stroke ( as diagnosed on neuroimaging and determined by the Chedoke-McMaster score 3 .
-METHODS	The STROKE REHAB software for the iPad was specifically designed for patients with fine motor weakness and/or neglect .
-METHODS	Of the total 30 patients , 20 will be in iHOME Acute ( enrolled within three-months of stroke onset ) and 10 patients in iHOME Chronic ( enrolled more than six-months from onset ) .
-METHODS	The primary feasibility outcome is the proportion of the scheduled iPad time used ( more than 70 % ( 140 mins ) of the total ` dose ' of intervention intended will be considered successful ) .
-METHODS	Efficacy in fine motor movements will be assessed using the nine-hole peg test ; time to magnify and pop the balloons in the iPad software application , and improvement in Wolf Motor Function Test .
-CONCLUSIONS	iHOME is a randomized controlled trial assessing the feasibility , safety , and efficacy of tablet technology for home use in stroke rehabilitation .
-CONCLUSIONS	The results of this study will serve as the basis for a larger multicenter trial .
-
-###24898154
-BACKGROUND	Breast-conserving treatment ( BCT ) leads to a progressive and deteriorating breast deformity .
-BACKGROUND	Fatgrafting is ideal for breast reconstruction after BCT .
-BACKGROUND	The most frequently utilized technique for fat processing is centrifugation .
-BACKGROUND	The PureGraft device ( Cytori Therapeutics , San Diego , CA , USA ) is a new method that involves washing and filtering the fat to prepare the graft .
-BACKGROUND	We compared the subjective and objective outcomes of two fat-processing methods , centrifugation and PureGraft filtration .
-METHODS	Thirty patients underwent breast reconstruction performed by a single surgeon ( OM ) after BCT in our department between April 2011 and September 2012 .
-METHODS	The patients were preoperatively divided into two groups randomly : 15 received fatgrafts processed by centrifugation , and 15 received fatgrafts processed by washing in PureGraft bags .
-METHODS	The patients were followed up for 12 to 30 months .
-METHODS	To measure the subjective outcome , we distributed the BREAST-Q questionnaire to all the patients both preoperatively and 1 year postoperatively .
-METHODS	The BCCT.core software evaluated the objective outcome of breast reconstruction by fatgrafting .
-RESULTS	The Breast-Q results indicated a tremendous improvement in the modules `` Satisfaction with Breast '' and `` Psychosocial Well-being '' .
-RESULTS	The `` Sexual Well-being '' scale also improved .
-RESULTS	Only the module `` Satisfaction with Breasts '' significantly differed between groups ; patients treated with the PureGraft fat exhibited better outcomes .
-RESULTS	The BCCT.core results did not significantly differ between the groups .
-CONCLUSIONS	One year postoperatively , the outcomes of the use of PureGraft bags or centrifugation to process fat for breast reconstruction after BCT did not differ .
-CONCLUSIONS	The unpredictability of the results following fatgrafting procedures is likely due to interindividual differences with yet-undisclosed causes .
-
-###24249542
-OBJECTIVE	Laparoscopic radical prostatectomy ( LARP ) may cause stress urinary incontinence ( SUI ) .
-OBJECTIVE	This study reports the effects of preoperative pelvic floor muscle therapy ( PFMT ) on SUI and quality of life ( QoL ) in men undergoing LARP .
-METHODS	In this single-center randomized controlled trial , 122 patients undergoing LARP were assigned to an intervention group of PFMT with biofeedback once a week preoperatively , with 4 weeks ' follow-up or to a control group receiving standard care .
-METHODS	Randomization and allocation to the trial group were carried out by a central computer system .
-METHODS	The primary analysis was based on 121 ( n = 65 ; n = 56 ) , comparing SUI rates and QoL in the two groups in a 1-year follow-up .
-METHODS	Validated questionnaires , the Pelvic Floor Inventories ( PeLFls ) , the King 's Health Questionnaire ( KHQ ) , the International Prostate Symptom Score ( IPSS ) , a bladder diary , a 24-hr pad test and pelvic floor examination were used .
-METHODS	Continence was defined as no leakage at all .
-METHODS	All analyses were performed according to intention-to-treat .
-RESULTS	One hundred twenty-two patients were randomized , 19 patients were excluded from analysis because of early drop-out .
-RESULTS	There were no significant differences between both groups in the incidence of SUI and QoL based on the KHQ , IPSS , and pad tests ( P 0.05 ) .
-RESULTS	In all patients continence was achieved in 77.2 % at 1 year postoperatively .
-CONCLUSIONS	Preoperative PFMT does not appear to be effective in the prevention of SUI and QoL following LARP .
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-###25416480
-BACKGROUND	Benzodiazepines and related drugs affect physical functioning negatively and increase fall and fracture risk .
-BACKGROUND	As impaired muscle strength and balance are risk factors for falls , we examined the effects of hypnotic withdrawal on handgrip strength and balance in older adult outpatients during and after long-term use of temazepam , zopiclone and zolpidem ( here collectively referred to as `` benzodiazepines '' ) .
-METHODS	Eighty-nine chronic users ( 59 women , 30 men ) of temazepam , zopiclone or zolpidem aged 55 years participated in a benzodiazepine withdrawal study .
-METHODS	Individual physician-directed withdrawal was performed gradually over a one-month period and participants were followed up to six months .
-METHODS	Handgrip strength was assessed using a handheld dynamometer , and balance using the Short Berg 's Balance Scale during the period of benzodiazepine use ( baseline ) , and at 1 , 2 , 3 weeks , and 1 , 2 and 6 months after initiating withdrawal .
-METHODS	Withdrawal outcome and persistence were determined by plasma benzodiazepine-determinations at baseline and at four weeks ( `` short-term withdrawers '' , n = 69 ; `` short-term non-withdrawers '' , n = 20 ) , and by interviews at six months ( `` long-term withdrawers '' , n = 34 ; `` long-term non-withdrawers '' , n = 55 ) .
-METHODS	Also most of the non-withdrawers markedly reduced their benzodiazepine use .
-RESULTS	Within three weeks after initiating withdrawal , handgrip strength improved significantly ( P0 .005 ) compared to baseline values .
-RESULTS	Among women , long-term withdrawers improved their handgrip strength both when compared to their baseline values ( P = 0.001 ) or to non-withdrawers ( P = 0.004 ) .
-RESULTS	In men , improvement of handgrip strength from baseline was not significantly better in withdrawers than in non-withdrawers .
-RESULTS	However , men did improve their handgrip strength values compared to baseline ( P = 0.002 ) .
-RESULTS	Compared to balance test results at baseline , withdrawers improved starting from the first week after withdrawal initiation .
-RESULTS	There was , however , only a borderline difference ( P = 0.054 ) in balance improvement between the long-term withdrawers and long-term non-withdrawers .
-RESULTS	Of note , the non-withdrawers tended to improve their handgrip strength and balance compared to baseline values , in parallel with their reduced benzodiazepine use .
-CONCLUSIONS	Withdrawal from long-term use of benzodiazepines can rapidly improve muscle strength and balance .
-CONCLUSIONS	Our results encourage discontinuing benzodiazepine hypnotics , particularly in older women who are at a high risk of falling and sustaining fractures .
-BACKGROUND	EU Clinical Trials Register : EudraCT2008000679530 .
-BACKGROUND	Registered 31 October 2008 .
-
-###25275069
-OBJECTIVE	To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating chemotherapy-naive patients with advanced Non-Small Cell Lung Cancer ( NSCLC ) .
-METHODS	Patients were randomized to receive daily erlotinib for 12 consecutive days prior to docetaxel ( Arm A ) or after docetaxel ( Arm B ) .
-METHODS	Progression-free survival ( PFS ) was the primary end-point ; secondary end-points were overall survival ( OS ) and objective response rate ( ORR ) .
-RESULTS	Fifty eligible patients received a total of 226 treatment cycles ( median : 3 ) .
-RESULTS	Median PFS and OS were 3.6 months and 10.5 months , respectively ( differences were not statistically significant between the two arms ) .
-RESULTS	Neutropenia grade 3 and 4 occurred in 15 patients , while two patients developed grade 3 diarrhea .
-RESULTS	There were two treatment-related deaths ( pulmonary embolism and non-neutropenic sepsis ) .
-CONCLUSIONS	Intermittent administration of erlotinib does not appear to improve the clinical outcome of single-agent docetaxel chemotherapy in unselected patients with NSCLC in the first-line setting .
-
-###25147079
-BACKGROUND	The autonomic system is an important determinant of atrial arrhythmogenesis .
-BACKGROUND	Current evidence indicates that a combined sympathovagal drive is most commonly responsible for eliciting atrial fibrillation ( AF ) episodes .
-BACKGROUND	The purpose of this study was to test whether moxonidine , a centrally acting sympathoinhibitory agent , can lead to a reduction in postablation AF recurrence .
-RESULTS	This was a prospective , double-blinded , randomized study of 291 hypertensive patients with symptomatic paroxysmal AF who were scheduled to undergo pulmonary vein isolation .
-RESULTS	Patients were randomly assigned to receive either moxonidine ( 0.2-0 .4 mg daily ) or placebo , along with standard antihypertensive treatment .
-RESULTS	No significant differences in blood pressure levels were observed between the 2 groups .
-RESULTS	In the primary outcome analysis , mean recurrence-free survival was 467 days ( 95 % CI , 445-489 days ) in the moxonidine group as compared with 409 days ( 95 % CI , 381-437 days ) in control subjects ( log rank test , P = 0.006 ) .
-RESULTS	The calculated 12-month recurrence rate estimates were 36.9 % in the control group and 20.0 % in the moxonidine group ( P = 0.007 ) .
-RESULTS	Moxonidine treatment was associated with lower recurrence risk after adjustment for age , body mass index , number of AF episodes in the previous year , and left atrial diameter ( adjusted hazard ratio , 0.35 [ 95 % CI , 0.22-0 .55 ] ; P < 0.001 ) .
-CONCLUSIONS	Treatment with moxonidine is associated with less AF recurrences after ablation treatment for drug-refractory AF in patients with hypertension .
-CONCLUSIONS	The observed effect does not appear to depend on the antihypertensive action of this agent .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT01791699 .
-
-###24716739
-BACKGROUND	Erosive degenerative disc disease , also known as Modic type 1 changes , is usually characterized by low back pain with an inflammatory pain pattern , as seen in spondyloarthropathies .
-BACKGROUND	Intravenous pamidronate has proven to be effective in patients with ankylosing spondylitis who are refractory to nonsteroidal antiinflammatory drugs , and in painful bone diseases in general , such as Paget 's disease , fibrous dysplasia or vertebral fractures .
-BACKGROUND	We therefore hypothesize that pamidronate would be effective in treating low back pain associated with Modic type 1 changes .
-METHODS	This study , called PEPTIDE ( short for the French title `` Etude Prospective sur l'Efficacit et la tolrance du PamidronaTe dans les dIscopathies Degeneratives Erosives '' ) , will be a double-blind , randomized , placebo-controlled , parallel group , phase two clinical trial .
-METHODS	A total of 48 patients will be recruited .
-METHODS	These patients will be randomly assigned to one of the two groups , with 24 patients in each group : one group will be given pamidronate and the other a placebo .
-METHODS	Pamidronate will be administered at a dose of 90mg per day for two days consecutively , and every patient , irrespective of treatment group , will be given paracetamol to maintain blinding by preventing drug-induced fever .
-METHODS	The primary outcome measure is a between-group difference of 30 points on a 100mm Visual Analogue Scale ( VAS ) at three months .
-METHODS	Secondary outcome measures are improvement in functional status and the drug 's safety .
-METHODS	Primary and secondary outcome measures will be assessed at each visit ( inclusion , at six weeks , three months , and six months ) .
-METHODS	If the primary goal is not attained , the patient will be offered a rigid or semi-rigid back brace , irrespective of the treatment group .
-CONCLUSIONS	To date , only local treatments , for example intradiscal corticosteroid therapy , lumbar arthrodesis or back braces have been studied in randomized , controlled trials , with controversial results .
-CONCLUSIONS	This trial is currently ongoing and , if conclusive , should provide physicians with an acceptable alternative to those treatments .
-CONCLUSIONS	The results should be publicly available in spring 2015 .
-BACKGROUND	ClinicalTrials.gov number , NCT01799616 .
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-###24415868
-OBJECTIVE	To analyze hepatitis C virus ( HCV ) - specific immune responses in chronically infected patients under triple therapy with interferon - ( IFN - ) plus ribavirin and CIGB-230 .
-METHODS	CIGB-230 was administered in different schedules with respect to IFN - plus ribavirin therapy .
-METHODS	Paired serum and peripheral blood mononuclear cells ( PBMC ) samples from baseline and end of treatment were analyzed .
-METHODS	The HCV-specific humoral response was tested by enzyme-linked immunosorbent assay , neutralizing antibodies were evaluated by cell culture HCV neutralization assays , PBMC proliferation was assayed by carboxyfluorescein succinimidyl ester staining and IFN - secretion was assessed by enzyme-linked immunospot .
-METHODS	Data on virological and histological response and their association with immune variables are also provided .
-RESULTS	From week 12 to week 48 , all groups of patients showed a significant reduction in mean leukocyte counts .
-RESULTS	Statistically significant reductions in antibody titers were frequent , but only individuals immunized with CIGB-230 as early add-on treatment sustained the core-IgG response , and the neutralizing antibody response was enhanced only in patients receiving CIGB-230 .
-RESULTS	Cell-mediated immune responses also tended to decline , but significant reductions in IFN - secretion and total absence of core-specific lymphoproliferation were exclusive of the control group .
-RESULTS	Only CIGB-230-immunized individuals showed de novo induced lymphoproliferative responses against the structural antigens .
-RESULTS	Importantly , it was demonstrated that the quality of the CIGB-230-induced immune response depended on the number of doses and timing of administration in relation to the antiviral therapy .
-RESULTS	Specifically , the administration of 6 doses of CIGB-230 as late add-on to therapy increased the neutralizing antibody activity and the de novo core-specific IFN - secretion , both of which were associated with the sustained virological response .
-CONCLUSIONS	CIGB-230 , combined with IFN -- based therapy , modifies the immune response in chronic patients .
-CONCLUSIONS	The study provides evidence for the design of more effective therapeutic vaccine interventions against HCV .
-
-###24448757
-OBJECTIVE	Evaluating the role of cystone , a polyherbal preparation , in protecting cancer patients against cisplatin-induced nephrotoxicity , and its impact on the cytotoxic activity of cisplatin .
-METHODS	A prospective open-label randomized controlled trial conducted on 49 cancer patients who received six cycles of 70 mg/m ( 2 ) cisplatin-based regimens .
-METHODS	The study comprised two groups , a control group ( A ) in which 28 patients received cisplatin without cystone supplement , and an experimental group ( B ) in which 21 patients received cisplatin with cystone supplement .
-METHODS	Renal function parameters including serum creatinine , creatinine clearance , blood urea , and serum cystatin C were compared between both groups throughout chemotherapy cycles .
-METHODS	Patient response to treatment was evaluated in both groups after 3rd and 6th cycles .
-RESULTS	At the end of the study , mean levels of serum creatinine , blood urea , and serum cystatin C were significantly lower , whereas creatinine clearance was significantly higher in group ( B ) compared with group ( A ) .
-RESULTS	In group ( B ) , there was no significant difference between mean levels of renal markers at baseline and after completion of treatment ; while significant changes were observed in group ( A ) .
-RESULTS	Grading of acute kidney injury according to Common Terminology Criteria for Adverse Events revealed significantly better renal status among patients in group ( B ) `` grades 0 and 1 in 76 and 24 % of the patients , respectively '' compared with group ( A ) `` grades 0 , 1 , and 2 in 36 , 32 , and 32 % of the patients , respectively '' .
-RESULTS	Based on Response Evaluation Criteria in Solid Tumors , there was no significant difference between both groups .
-CONCLUSIONS	Cystone can protect cancer patients from cisplatin nephrotoxicity without interfering with its antitumor activity .
-
-###25440816
-OBJECTIVE	To present the outcomes of flexible ureteroscopy ( F-URS ) , shock wave lithotripsy ( SWL ) , and observation in the management of asymptomatic lower calyceal stones .
-METHODS	A total of 150 patients with asymptomatic lower calyceal stones were randomized into F-URS ( group 1 ) , SWL ( group 2 ) , and observation ( group 3 ) groups .
-METHODS	The main criteria for patient enrollment were having asymptomatic single lower pole stones < 1 cm .
-RESULTS	In F-URS , the mean stone-free rate was 92 % ( 46 of 50 ) .
-RESULTS	The mean number of sessions for the SWL group was 1.48 0.65 .
-RESULTS	Stone-free rate was 90 % ( 45 of 50 ) .
-RESULTS	In the observation group , patients were followed up for a mean of 21.02 3.65 months .
-RESULTS	Three stones passed spontaneously without any symptoms .
-RESULTS	Pain developed in 3 patients during follow-up , and 2 of them passed a stone and responded to analgesics without further treatment .
-RESULTS	Complication rates for groups 1 and 2 were similar , but group 2 had higher Clavien grades .
-CONCLUSIONS	For asymptomatic small-sized lower calyceal stones , SWL and F-URS are established treatment modalities .
-CONCLUSIONS	However , with low auxiliary treatment rates , observation may be an option for the management of nonsymptomatic small-sized lower pole kidney stones .
-
-###25934853
-OBJECTIVE	To determine whether the tumor necrosis factor inhibitor etanercept is well tolerated and obtain preliminary data on its safety in Alzheimer disease dementia .
-METHODS	In a double-blind study , patients with mild to moderate Alzheimer disease dementia were randomized ( 1:1 ) to subcutaneous etanercept ( 50 mg ) once weekly or identical placebo over a 24-week period .
-METHODS	Tolerability and safety of this medication was recorded including secondary outcomes of cognition , global function , behavior , and systemic cytokine levels at baseline , 12 weeks , 24 weeks , and following a 4-week washout period .
-METHODS	This trial is registered with EudraCT ( 2009-013400-31 ) and ClinicalTrials.gov ( NCT01068353 ) .
-RESULTS	Forty-one participants ( mean age 72.4 years ; 61 % men ) were randomized to etanercept ( n = 20 ) or placebo ( n = 21 ) .
-RESULTS	Etanercept was well tolerated ; 90 % of participants ( 18/20 ) completed the study compared with 71 % ( 15/21 ) in the placebo group .
-RESULTS	Although infections were more common in the etanercept group , there were no serious adverse events or new safety concerns .
-RESULTS	While there were some interesting trends that favored etanercept , there were no statistically significant changes in cognition , behavior , or global function .
-CONCLUSIONS	This study showed that subcutaneous etanercept ( 50 mg/wk ) was well tolerated in this small group of patients with Alzheimer disease dementia , but a larger more heterogeneous group needs to be tested before recommending its use for broader groups of patients .
-METHODS	This study shows Class I evidence that weekly subcutaneous etanercept is well tolerated in Alzheimer disease dementia .
-
-###25312556
-BACKGROUND	Internet-based Smoking Cessation Interventions ( ISCIs ) may help pregnant smokers who are unable , or unwilling , to access face-to-face stop smoking support .
-BACKGROUND	Targeting ISCIs to specific groups of smokers could increase their uptake and effectiveness .
-BACKGROUND	The current study explored the needs and preferences of pregnant women seeking online stop smoking support with an aim to identify features and components of ISCIs that might be most attractive to this population .
-METHODS	We conducted qualitative interviews with thirteen pregnant women who completed the intervention arm of a pilot randomized controlled trial of a novel ISCI for pregnant smokers ( ` MumsQuit ' ) .
-METHODS	The interviews explored women 's views towards MumsQuit and online support with quitting smoking in general , as well as their suggestions for how ISCIs could be best targeted to pregnancy .
-METHODS	Interview transcripts were analyzed using Framework Analysis .
-RESULTS	Participants expressed preferences for an accessible , highly engaging and targeted to pregnancy smoking cessation website , tailored to individuals ' circumstances as well as use of cessation medication , offering comprehensive and novel information on smoking and quitting smoking in pregnancy , ongoing support with cravings management , as well as additional support following relapse to smoking .
-RESULTS	Participants also viewed as important targeting of the feedback and progress reports to baby 's health and development , offering personal support from experts , and providing a discussion forum allowing for communication with other pregnant women wanting to quit .
-CONCLUSIONS	The present study has identified a number of potential building blocks for ISCIs targeted to quitting smoking in pregnancy .
-CONCLUSIONS	Pregnant smokers willing to try using ISCI may particularly value an engaging intervention offering a high degree of targeting of comprehensive information to them as a group and tailoring support and advice to their individual needs , as well as one providing post-relapse support , peer-to-peer communication and personal support from experts .
-
-###25361222
-OBJECTIVE	A prospective randomized phase II trial was conducted to evaluate the efficacy of ghrelin administration in reducing systemic inflammatory response syndrome ( SIRS ) duration after esophagectomy .
-BACKGROUND	Esophagectomy for esophageal cancer is highly invasive and leads to prolonged SIRS duration and postoperative complications .
-BACKGROUND	Ghrelin has multiple effects , including anti-inflammatory effects .
-METHODS	Forty patients undergoing esophagectomy were randomly assigned to either the ghrelin group ( n = 20 ) , which received continuous infusion of ghrelin ( 0.5 g/kg/h ) for 5 days , or the placebo group ( n = 20 ) , which received pure saline for 5 days .
-METHODS	The primary endpoint was SIRS duration .
-METHODS	The secondary endpoints were the incidence of postoperative complications , time of a negative nitrogen balance , changes in body weight and composition , and levels of inflammatory markers , including C-reactive protein ( CRP ) and interleukin-6 ( IL-6 ) .
-RESULTS	The ghrelin group had a shorter SIRS duration and lower CRP and IL-6 levels than did the placebo group .
-RESULTS	The incidence of pulmonary complications was lower in the ghrelin group than in the placebo group , whereas other complications did not differ between the groups .
-RESULTS	Although time of the negative nitrogen balance was shorter in the ghrelin group than in the placebo group , changes in total body weight and lean body weight did not differ significantly .
-CONCLUSIONS	Postoperative ghrelin administration was effective for inhibiting inflammatory mediators and improving the postoperative clinical course of patients with esophageal cancer .
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-###24290209
-BACKGROUND	Smoking during pregnancy is common , and quitting at any point during pregnancy can yield benefits to both the fetus and mother .
-BACKGROUND	Smoking cessation is typically followed by withdrawal symptoms and a strong desire to smoke , both of which are likely to contribute to relapse .
-BACKGROUND	Research has shown that a bout of exercise minimizes cravings and tobacco withdrawal symptoms ( TWS ) after temporary abstinence in smokers , but these findings have not been replicated in pregnant smokers .
-BACKGROUND	This study examined the effect of 20min of exercise on cravings ( primary outcome ) and TWS ( secondary outcomes ) among temporary abstinent , inactive pregnant smokers .
-METHODS	Thirty female smokers ( Mean ( M ) age = 25.7 years , Standard Deviation ( SD ) = 5.5 ; M weeks pregnant = 18.2 , SD = 5.3 ; Fagerstrom Test for Cigarette Dependence = 3.3 , SD = 2.2 ; M 9.3 cigarettes/day , SD = 4.7 ; M hours abstained = 17.2 , SD = 2.8 ) were randomized to 20 min of mild-to-moderate intensity exercise ( EC ; n = 14 ) or passive ( PC ; n = 16 ) condition .
-METHODS	Cravings and TWS were assessed immediately before , during ( at 10 min ) , immediately post , and at 10 , 20 , and 30 min post-condition .
-RESULTS	A 2 ( condition ) 6 ( time ) repeated measures ANOVA revealed that the EC significantly ( p < 0.05 ) reduced cravings ( ( 2 ) = 0.46 ) compared with the PC , across time .
-RESULTS	Non-significant , but nevertheless , large effects were evident favouring the EC over time for TWS restlessness ( ( 2 ) = 0.34 ) , stress ( ( 2 ) = 0.24 ) , irritability ( ( 2 ) = 0.21 ) , tension ( ( 2 ) = 0.15 ) , and depression ( ( 2 ) = 0.14 ) .
-CONCLUSIONS	Consistent with previous research , this study reveals that in pregnant smokers , a bout of exercise is associated with a reduction in cravings and similar patterns exist for TWS .
-CONCLUSIONS	Therefore , exercise may have the potential to assist in the initial stages of smoking cessation attempts during pregnancy .
-
-###24334857
-BACKGROUND	The clinical efficacy of autologous blood therapy ( ABT ) in patients with atopic dermatitis ( AD ) was demonstrated by a randomized double-blind placebo-controlled study .
-BACKGROUND	To characterize the blood component mediating the therapeutic efficacy of ABT for AD , we evaluated the clinical efficacy of autologous plasma therapy ( APT ) and autologous high-molecular-weight plasma protein fraction therapy ( AHPT ) in patients with AD in this study .
-METHODS	A total of 22 patients with recalcitrant AD were treated with 8 weekly intramuscular injections of either autologous plasma ( n = 11 ) or autologous high-molecular-weight plasma protein fraction ( n = 11 ) for 7 weeks .
-RESULTS	The clinical severity score of AD ( SCORAD value ) of 11 patients who completed AHPT significantly decreased from 79.7 17.0 ( mean SD ) at baseline to 65.8 16.4 at 6 weeks and 60.1 16.0 at 7 weeks ( Wilcoxon signed-rank test , p < 0.05 ) .
-RESULTS	There were no significant differences among the SCORAD values measured at baseline ( 74.2 19.6 ) , at 6 weeks ( 66.3 23.6 ) and at 7 weeks ( 67.5 20.8 ) in 10 patients who completed APT ( p > 0.05 ) .
-CONCLUSIONS	This result suggests that the blood component mediating the therapeutic efficacy of ABT in patients with AD might be present in the high-molecular-weight plasma protein fraction .
-
-###25601979
-OBJECTIVE	Data from a randomized , controlled study of adenotonsillectomy for obstructive sleep apnea syndrome ( OSAS ) were used to test the hypothesis that children undergoing surgery had greater quality of life ( QoL ) and symptom improvement than control subjects .
-OBJECTIVE	The objectives were to compare changes in validated QoL and symptom measurements among children randomized to undergo adenotonsillectomy or watchful waiting ; to determine whether race , weight , or baseline OSAS severity influenced changes in QoL and symptoms ; and to evaluate associations between changes in QoL or symptoms and OSAS severity .
-METHODS	Children aged 5 to 9.9 years with OSAS ( N = 453 ) were randomly assigned to undergo adenotonsillectomy or watchful waiting with supportive care .
-METHODS	Polysomnography , the Pediatric Quality of Life inventory , the Sleep-Related Breathing Scale of the Pediatric Sleep Questionnaire , the 18-item Obstructive Sleep Apnea QoL instrument , and the modified Epworth Sleepiness Scale were completed at baseline and 7 months .
-METHODS	Changes in the QoL and symptom surveys were compared between arms .
-METHODS	Effect modification according to race and obesity and associations between changes in polysomnographic measures and QoL or symptoms were examined .
-RESULTS	Greater improvements in most QoL and symptom severity measurements were observed in children randomized to undergo adenotonsillectomy , including the parent-completed Pediatric Quality of Life inventory ( effect size [ ES ] : 0.37 ) , the 18-item Obstructive Sleep Apnea QoL instrument ( ES : -0.93 ) , the modified Epworth Sleepiness Scale score ( ES : -0.42 ) , and the Sleep-Related Breathing Scale of the Pediatric Sleep Questionnaire ( ES : -1.35 ) .
-RESULTS	Effect modification was not observed by obesity or baseline severity but was noted for race in some symptom measures .
-RESULTS	Improvements in OSAS severity explained only a small portion of the observed changes .
-CONCLUSIONS	Adenotonsillectomy compared with watchful waiting resulted in significantly more improvements in parent-rated generic and OSAS-specific QoL measures and OSAS symptoms .
-
-###26135706
-BACKGROUND	High doses of intravenous methylprednisolone are recommended to treat relapses in patients with multiple sclerosis , but can be inconvenient and expensive .
-BACKGROUND	We aimed to assess whether oral administration of high-dose methylprednisolone was non-inferior to intravenous administration .
-METHODS	We did this multicentre , double-blind , randomised , controlled , non-inferiority trial at 13 centres for multiple sclerosis in France .
-METHODS	We enrolled patients aged 18-55 years with relapsing-remitting multiple sclerosis who reported a relapse within the previous 15 days that caused an increase of at least one point in one or more scores on the Kurtzke Functional System Scale .
-METHODS	With use of a computer-generated randomisation list and in blocks of four , we randomly assigned ( 1:1 ) patients to either oral or intravenous methylprednisolone , 1000 mg , once a day for 3 days .
-METHODS	Patients , treating physicians and nurses , and data and outcome assessors were all masked to treatment allocation , which was achieved with the use of saline solution and placebo capsules .
-METHODS	The primary endpoint was the proportion of patients who had improved by day 28 ( decrease of at least one point in most affected score on Kurtzke Functional System Scale ) , without need for retreatment with corticosteroids , in the per-protocol population .
-METHODS	The trial was powered to assess non-inferiority of oral compared with intravenous methylprednisolone with a predetermined non-inferiority margin of 15 % .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT00984984 .
-RESULTS	Between Jan 29 , 2008 , and June 14 , 2013 , we screened 200 patients and enrolled 199 .
-RESULTS	We randomly assigned 100 patients to oral methylprednisolone and 99 patients to intravenous methylprednisolone with a mean time from relapse onset to treatment of 70 days ( SD 36 ) and 74 days ( 39 ) , respectively .
-RESULTS	In the per-protocol population , 66 ( 81 % ) of 82 patients in the oral group and 72 ( 80 % ) of 90 patients in the intravenous group achieved the primary endpoint ( absolute treatment difference 05 % , 90 % CI -95 to 104 ) .
-RESULTS	Rates of adverse events were similar , but insomnia was more frequently reported in the oral group ( 77 [ 77 % ] ) than in the intravenous group ( 63 [ 64 % ] ) .
-CONCLUSIONS	Oral administration of high-dose methylprednisolone for 3 days was not inferior to intravenous administration for improvement of disability scores 1 month after treatment and had a similar safety profile .
-CONCLUSIONS	This finding could have implications for access to treatment , patient comfort , and cost , but indication should always be properly considered by clinicians .
-BACKGROUND	French Health Ministry , Ligue Franaise contre la SEP , Teva .
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-###25755233
-BACKGROUND	Electronic health record ( EHR ) - linked patient portals are a promising approach to facilitate shared decision-making between families of children with chronic conditions and pediatricians .
-BACKGROUND	This study evaluated the feasibility , acceptability , and impact of MyAsthma , an EHR-linked patient portal supporting shared decision-making for pediatric asthma .
-METHODS	We conducted a 6-month randomized controlled trial of MyAsthma at 3 primary care practices .
-METHODS	Families were randomized to MyAsthma , which tracks families ' asthma treatment concerns and goals , children 's asthma symptoms , medication side effects and adherence , and provides decision support , or to standard care .
-METHODS	Outcomes included the feasibility and acceptability of MyAsthma for families , child health care utilization and asthma control , and the number of days of missed school ( child ) and work ( parent ) .
-METHODS	Descriptive statistics and longitudinal regression models assessed differences in outcomes between study arms .
-RESULTS	We enrolled 60 families , 30 in each study arm ( mean age 8.3 years ) ; 57 % of parents in the intervention group used MyAsthma during at least 5 of the 6 study months .
-RESULTS	Parents of children with moderate to severe persistent asthma used the portal more than others ; 92 % were satisfied with MyAsthma .
-RESULTS	Parents reported that use improved their communication with the office , ability to manage asthma , and awareness of the importance of ongoing attention to treatment .
-RESULTS	Parents in the intervention group reported that children had a lower frequency of asthma flares and intervention parents missed fewer days of work due to asthma .
-CONCLUSIONS	Use of an EHR-linked asthma portal was feasible and acceptable to families and improved clinically meaningful outcomes .
-
-###25913272
-BACKGROUND	The efficacy and safety of the RTS , S/AS01 candidate malaria vaccine during 18 months of follow-up have been published previously .
-BACKGROUND	Herein , we report the final results from the same trial , including the efficacy of a booster dose .
-METHODS	From March 27 , 2009 , until Jan 31 , 2011 , children ( age 5-17 months ) and young infants ( age 6-12 weeks ) were enrolled at 11 centres in seven countries in sub-Saharan Africa .
-METHODS	Participants were randomly assigned ( 1:1:1 ) at first vaccination by block randomisation with minimisation by centre to receive three doses of RTS , S/AS01 at months 0 , 1 , and 2 and a booster dose at month 20 ( R3R group ) ; three doses of RTS , S/AS01 and a dose of comparator vaccine at month 20 ( R3C group ) ; or a comparator vaccine at months 0 , 1 , 2 , and 20 ( C3C [ control group ] ) .
-METHODS	Participants were followed up until Jan 31 , 2014 .
-METHODS	Cases of clinical and severe malaria were captured through passive case detection .
-METHODS	Serious adverse events ( SAEs ) were recorded .
-METHODS	Analyses were by modified intention to treat and per protocol .
-METHODS	The coprimary endpoints were the occurrence of malaria over 12 months after dose 3 in each age category .
-METHODS	In this final analysis , we present data for the efficacy of the booster on the occurrence of malaria .
-METHODS	Vaccine efficacy ( VE ) against clinical malaria was analysed by negative binomial regression and against severe malaria by relative risk reduction .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT00866619 .
-RESULTS	8922 children and 6537 young infants were included in the modified intention-to-treat analyses .
-RESULTS	Children were followed up for a median of 48 months ( IQR 39-50 ) and young infants for 38 months ( 34-41 ) after dose 1 .
-RESULTS	From month 0 until study end , compared with 9585 episodes of clinical malaria that met the primary case definition in children in the C3C group , 6616 episodes occurred in the R3R group ( VE 363 % , 95 % CI 318-405 ) and 7396 occurred in the R3C group ( 283 % , 233-329 ) ; compared with 171 children who experienced at least one episode of severe malaria in the C3C group , 116 children experienced at least one episode of severe malaria in the R3R group ( 322 % , 137 to 469 ) and 169 in the R3C group ( 11 % , -230 to 205 ) .
-RESULTS	In young infants , compared with 6170 episodes of clinical malaria that met the primary case definition in the C3C group , 4993 episodes occurred in the R3R group ( VE 259 % , 95 % CI 199-315 ) and 5444 occurred in the R3C group ( 183 % , 117-244 ) ; and compared with 116 infants who experienced at least one episode of severe malaria in the C3C group , 96 infants experienced at least one episode of severe malaria in the R3R group ( 173 % , 95 % CI -94 to 375 ) and 104 in the R3C group ( 103 % , -179 to 318 ) .
-RESULTS	In children , 1774 cases of clinical malaria were averted per 1000 children ( 95 % CI 1387-2186 ) in the R3R group and 1363 per 1000 children ( 995-1797 ) in the R3C group .
-RESULTS	The numbers of cases averted per 1000 young infants were 983 ( 95 % CI 592-1337 ) in the R3R group and 558 ( 158-926 ) in the R3C group .
-RESULTS	The frequency of SAEs overall was balanced between groups .
-RESULTS	However , meningitis was reported as a SAE in 22 children : 11 in the R3R group , ten in the R3C group , and one in the C3C group .
-RESULTS	The incidence of generalised convulsive seizures within 7 days of RTS , S/AS01 booster was 22 per 1000 doses in young infants and 25 per 1000 doses in children .
-CONCLUSIONS	RTS , S/AS01 prevented a substantial number of cases of clinical malaria over a 3-4 year period in young infants and children when administered with or without a booster dose .
-CONCLUSIONS	Efficacy was enhanced by the administration of a booster dose in both age categories .
-CONCLUSIONS	Thus , the vaccine has the potential to make a substantial contribution to malaria control when used in combination with other effective control measures , especially in areas of high transmission .
-BACKGROUND	GlaxoSmithKline Biologicals SA and the PATH Malaria Vaccine Initiative .
-
-###24309220
-OBJECTIVE	To evaluate the initial safety and effectiveness of the intrauterine ball ( IUB ) , a copper intrauterine device that , upon insertion in the uterus , takes a three-dimensional spherical form .
-METHODS	Fifteen women were followed for 1 year , with follow-up visits at 1 , 3 , 6 , 9 and 12 months .
-RESULTS	The physician reported that all devices were very easy to insert .
-RESULTS	One subject discontinued before the 6-month visit ( at 119 days after insertion ) for a reason not related to the device .
-RESULTS	There were no perforations , expulsions , malpositions or complications , or pregnancies .
-CONCLUSIONS	No safety or efficacy concerns were raised .
-CONCLUSIONS	Due to its form and deployment process the IUB is expected to ease insertion and reduce perforation , malposition and expulsion rates and may also reduce dysmenorrhea and menorrhagia .
-
-###24982396
-BACKGROUND	Biopharmaceutical studies for anti-cancer drugs are typically conducted in cancer patients due to unacceptable toxicities to healthy volunteers .
-BACKGROUND	Navitoclax is a first-in-class , orally bioavailable , targeted Bcl-2 family protein inhibitor that has been studied in cancer patients .
-METHODS	A strategy that integrated the evaluation of non-clinical toxicology data and clinical data in cancer patients was employed to assess the feasibility , determine doses and establish risk management plans for studying navitoclax in healthy volunteers .
-METHODS	Two relative bioavailability/food effect studies with either a 25 mg dose or 50 and 100 mg doses of navitoclax were conducted sequentially in healthy female volunteers of non-childbearing potential .
-CONCLUSIONS	Navitoclax was well-tolerated in both studies in healthy volunteers , and did not impose risks beyond the minimal levels expected in healthy volunteer studies .
-CONCLUSIONS	Compared to a similar study in cancer patients , the studies in healthy volunteers generated higher quality data in a short period of time to support formulation selection .
-
-###24382170
-OBJECTIVE	The aim of this study was to compare short - and long-term root coverage and aesthetic outcomes of the coronally advanced flap ( CAF ) alone or in combination with a connective tissue graft ( CTG ) for the treatment of multiple gingival recessions .
-METHODS	Fifty patients with multiple ( 2 ) adjacent gingival recessions ( 2 mm ) in the upper jaw were enrolled .
-METHODS	Twenty-five patients were randomly assigned to the control group ( CAF ) , and the other 25 patients to the test group ( CAF + CTG ) .
-METHODS	Clinical outcomes were evaluated at 6 months , 1 and 5 years .
-METHODS	The aesthetic evaluations were made 1 and 5 years after the surgery .
-RESULTS	No statistically significant difference was demonstrated between the two groups in terms of Rec Red and complete root coverage ( CRC ) at 6 months and 1 year .
-RESULTS	At 5 years , statistically greater recession reduction and probability of CRC , greater increase in buccal KTH and better contour evaluation made by an independent periodontist were observed in the CAF + CTG group .
-RESULTS	Better post-operative course and better colour match were demonstrated in CAF-treated patients both at 1 and 5 years .
-CONCLUSIONS	CAF + CTG provided better CRC at 5 years ; keloid formation due to graft exposure was responsible for the worse colour match evaluation .
-
-###25219601
-BACKGROUND	The root of Scutellaria baicalensis Georgi has been used extensively in traditional Chinese medicine for the treatment of inflammation , fever , cough , dysentery , and hypertension .
-BACKGROUND	Baicalein is a flavonoid isolated from the root of Scutellaria baicalensis Georgi and is a novel neuroprotective agent under development for the treatment of Parkinsons disease .
-BACKGROUND	We aimed to investigate the pharmacokinetic ( PK ) properties of baicalein and its main metabolite , bacalin , after single-dose administration in healthy Chinese subjects .
-BACKGROUND	The safety and tolerability of baicalein were also assessed .
-METHODS	This was a Phase I , randomized , double-blind , single-dose trial of baicalein ( 100-2800 mg ) in 72 healthy adults .
-METHODS	Samples of blood , urine and feces were collected at regular intervals up to 48 h after administration of the study drug .
-METHODS	Baicalein and baicalin were then analyzed using liquid chromatography-tandem mass spectrometry ( LC/MS/MS ) .
-METHODS	The maximum concentration that the drug achieved after dosing ( Cmax ) , time to Cmax ( Tmax ) , terminal half-life ( t / ) , area under the curve from time zero to time of last quantifiable concentration ( AUC ( 0 , t ) ) , area under the curve from time zero to infinity ( AUC ( 0 , ) ) , apparent total plasma clearance ( CL/F ) , and apparent total volume of distribution ( V/F ) were determined using non-compartmental models .
-METHODS	Dose proportion was tested using a method combining the equivalence criterion and power model .
-METHODS	Physical examinations , vital signs , ECG findings , hematology , and urinalysis were monitored before and at regular intervals after administration of the study drug .
-RESULTS	The PK profile of baicelein and baicelin was characterized by a median Tmax of 0.75-3 .5 h and 0.5-3 h , respectively , followed by a multiphasic profile with a t / of 1.90-15 .01 h and 4.22-10 .80 h , respectively .
-RESULTS	The estimates of the proportionality coefficient ( 90 % CI ) for Cmax , AUC-t and AUC - were 0.83 ( 0.70-0 .96 ) , 0.91 ( 0.81-1 .00 ) and 0.92 ( 0.82-1 .02 ) , respectively .
-RESULTS	All values overlapped within the pre-specified range of ( 0.89-1 .11 ) , ( 0.93-1 .07 ) , and ( 0.93-1 .07 ) , respectively .
-RESULTS	Dose proportionality was inconclusive for a baicalein dose range of 100-2800 mg .
-RESULTS	The total urinary clearance of baicalein and baicalin was < 1 % .
-RESULTS	Approximately 27 % of baicalein was eliminated as unchanged drug in feces .
-RESULTS	Baicalein was well tolerated .
-RESULTS	Eleven treatment-related adverse events were observed , and all were rated as `` mild '' and resolved without further treatment .
-RESULTS	No serious adverse events occurred .
-CONCLUSIONS	Single oral doses of 100-2800 mg of baicalein were safe and well tolerated by healthy subjects .
-CONCLUSIONS	Clinical laboratory assessments showed no signs of toxicity in the liver or kidney .
-CONCLUSIONS	The favorable safety profile and PK properties warrant further clinical studies for baicalein .
-
-###24444414
-OBJECTIVE	To assess the efficacy of continuous therapy ( cont ) and on-demand therapy ( on-demand ) as maintenance therapy for gastroesophageal reflux disease ( GERD ) .
-METHODS	Patients with upper GI endoscopy ( EGD ) - proven GERD who completed 8 weeks of initial therapy were randomized to cont ( omeprazole 20 mg od ) or on-demand ( omeprazole 20 mg on-demand ) group .
-METHODS	Assessments by the Global Overall Symptom ( GOS ) scale at baseline ( at the start of maintenance therapy ) and at 8-week , 16-week , and 24-week visits were made and EGD was performed at 24 weeks .
-METHODS	Symptom relief was defined as percentages of patients whose GOS score of 1 or 2 .
-RESULTS	Of the 117 enrolled patients , cont/on-demand was 59/58 and nonerosive reflux disease ( NERD ) / reflux esophagitis ( RE ) before the initial therapy was 35/82 .
-RESULTS	Symptom relief in cont/on-demand were 57.6 % / 48.3 % at baseline ( n.s. ) , 66.7 % / 54.7 % at 8 week ( n.s. ) , 64.6 % / 54.7 % at 16 weeks ( n.s. ) , and 66.7 % / 74.0 % at 24 weeks ( n.s. ) .
-RESULTS	When subjects were divided into NERD and RE , symptom relief in cont/on-demand were 33.3 % / 41.2 % at baseline ( n.s. ) , 43.8 % / 64.3 % at 8 weeks ( n.s. ) , 50.0 % / 42.9 % at 16 weeks ( n.s. ) , and 50.0 % / 69.2 % at 24 weeks ( n.s. ) in NERD , while those were 68.3 % / 51.2 % at baseline ( n.s. ) , 76.3 % / 51.3 % at 8 weeks ( p < 0.05 ) , 70.6 % / 59.0 % at 16 weeks ( n.s. ) , and 72.7 % / 75.7 % at 24 weeks ( n.s. ) in RE , respectively .
-RESULTS	At 24-week EGD , all patients in NERD remained as NERD but number of healed patients was significantly higher in cont ( 85.3 % ) than in on-demand ( 44.4 % ) ( p < 0.01 ) in RE .
-CONCLUSIONS	Since NERD is defined by symptoms , as a result of the limited efficacy of continuous therapy , on-demand therapy would be sufficient as maintenance therapy in NERD patients .
-CONCLUSIONS	Regarding RE , continuous therapy would be recommended in terms of reduced symptoms and maintaining mucosal healing .
-
-###25485803
-BACKGROUND	This was the second study in a Phase 3 program treating crow 's feet lines ( CFL ) with onabotulinumtoxinA .
-OBJECTIVE	To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL alone or with glabellar lines ( GL ) .
-METHODS	This multicenter , double-blind , placebo-controlled , repeat treatment , 7-month study randomized subjects with moderate-to-severe CFL and GL ( maximum contraction ) to onabotulinumtoxinA 44 U ( CFL : 24 U , GL : 20 U ; n = 305 ) , onabotulinumtoxinA 24 U ( CFL : 24 U , GL : placebo ; n = 306 ) , or placebo ( n = 306 ) .
-METHODS	Coprimary end points were investigator-assessed and subject-assessed proportion of subjects achieving a CFL Facial Wrinkle Scale Grade of 0 or 1 ( maximum smile ; Day 30 , Cycle 1 ) .
-METHODS	Additional efficacy end points and safety/adverse events ( AEs ) were evaluated .
-RESULTS	All primary and secondary end points were achieved ; statistically significant differences favored onabotulinumtoxinA ( p < .001 , all comparisons vs placebo ) .
-RESULTS	Investigator and subject responder rates were : CFL , 54.9 % and 45.8 % ; CFL + GL , 59.0 % and 48.5 % ; and placebo , 3.3 % ( both ) , respectively .
-RESULTS	Responder rates on other end points also significantly favored onabotulinumtoxinA treatments .
-RESULTS	Most AEs were mild or moderate .
-RESULTS	Two subjects discontinued : 1 serious AE unrelated to treatment ( myocardial infarction ) and 1 treatment-related AE ( injection site pain ) .
-CONCLUSIONS	OnabotulinumtoxinA was effective and well tolerated for treating moderate-to-severe CFL alone or in combination with GL .
-
-###25439038
-BACKGROUND	The decision to treat subclinical hypothyroidism ( SCH ) with or without autoimmune thyroiditis ( AIT ) in children , presents a clinical dilemma .
-BACKGROUND	This study was undertaken to evaluate the efficacy of individualized homeopathy in these cases .
-METHODS	The study is an exploratory , randomized , placebo controlled , single blind trial .
-METHODS	Out of 5059 school children ( 06-18 years ) screened for thyroid disorders , 537 children had SCH/AIT and 194 consented to participate .
-METHODS	Based on primary outcome measures ( TSH and/or antiTPOab ) three major groups were formed : Group A - SCH + AIT ( n = 38 ; high TSH with antiTPOab + ) , Group B - AIT ( n = 47 ; normal TSH with antiTPOab + ) and Group C - SCH ( n = 109 ; only high TSH ) and were further randomized to two subgroups-verum and control .
-METHODS	Individualized homeopathy or identical placebo was given to respective subgroup .
-METHODS	162 patients completed 18 months of study .
-RESULTS	Baseline characteristics were similar in all the subgroups .
-RESULTS	The post treatment serum TSH ( Group A and C ) returned to normal limits in 85.94 % of verum and 64.29 % of controls ( p < 0.006 ) , while serum AntiTPOab titers ( Group A and B ) returned within normal limits in 70.27 % of verum and 27.02 % controls ( p < 0.05 ) .
-RESULTS	Eight children ( 10.5 % ) progressed to overt hypothyroidism ( OH ) from control group .
-CONCLUSIONS	A statistically significant decline in serum TSH values and antiTPOab titers indicates that the homeopathic intervention has not only the potential to treat SCH with or without antiTPOab but may also prevent progression to OH .
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-###24283563
-BACKGROUND	There is little data to guide radiation oncologists on appropriate margin selection in the post-prostatectomy setting .
-BACKGROUND	The aim of this study was to quantify interfraction variation in motion of the prostate bed to determine these margins .
-METHODS	The superior and inferior surgical clips in the prostate bed were tracked on pretreatment cone beam CT images ( n = 377 ) for 40 patients who had received post-prostatectomy radiotherapy .
-METHODS	Prostate bed motion was calculated for the upper and lower segments by measuring the position of surgical clips located close to midline relative to bony anatomy in the axial ( translational ) and sagittal ( tilt ) planes .
-METHODS	The frequency of potential geographic misses was calculated for either 1cm or 0.5 cm posterior planning target volume margins .
-RESULTS	The mean magnitude of movement of the prostate bed in the anterior-posterior , superior-inferior and left-right planes , respectively , were as follows : upper portion , 0.50 cm , 0.28 cm , 0.10 cm ; lower portion , 0.18 cm , 0.18 cm , 0.08 cm .
-RESULTS	The random and systematic errors , respectively , of the prostate bed motion in the anterior-posterior , superior-inferior and left-right planes , respectively , were as follows : upper portion , 0.47 cm and 0.50 cm , 0.28 cm and 0.27 cm , 0.11 cm and 0.11 cm ; lower portion , 0.17 cm and 0.18 cm , 0.17 cm and 0.19 cm , 0.08 cm and 0.10 cm .
-RESULTS	Most geographic misses occurred in the upper prostate bed in the anterior-posterior plane .
-RESULTS	The median prostate bed tilt was 1.8 ( range -23.4 to 42.3 ) .
-CONCLUSIONS	Variability was seen in all planes for the movement of both surgical clips .
-CONCLUSIONS	The greatest movement occurred in the anterior-posterior plane in the upper prostate bed , which could cause geographic miss of treatment delivery .
-CONCLUSIONS	The variability in the movement of the superior and inferior clips indicates a prostate bed tilt that would be difficult to correct with standard online matching techniques .
-CONCLUSIONS	This creates a strong argument for using anisotropic planning target volume margins in post-prostatectomy radiotherapy .
-
-###24474647
-CONCLUSIONS	Male and female pattern hair loss are common , chronic dermatologic disorders with limited therapeutic options .
-CONCLUSIONS	In recent years , a number of commercial devices using low-level laser therapy have been promoted , but there have been little peer-reviewed data on their efficacy .
-OBJECTIVE	To determine whether treatment with a low-level laser device , the US FDA-cleared HairMax Lasercomb , increases terminal hair density in both men and women with pattern hair loss .
-METHODS	Randomized , sham device-controlled , double-blind clinical trials were conducted at multiple institutional and private practices .
-METHODS	A total of 146 male and 188 female subjects with pattern hair loss were screened .
-METHODS	A total of 128 male and 141 female subjects were randomized to receive either a lasercomb ( one of three models ) or a sham device in concealed sealed packets , and were treated on the whole scalp three times a week for 26 weeks .
-METHODS	Terminal hair density of the target area was evaluated at baseline and at 16 - and 26-week follow-ups , and analyzed to determine whether the hypothesis formulated prior to data collection , that lasercomb treatment would increase terminal hair density , was correct .
-METHODS	The site investigators and the subjects remained blinded to the type of device they dispensed/received throughout the study .
-METHODS	The evaluator of masked digital photographs was blinded to which trial arm the subject belonged .
-RESULTS	Seventy-eight , 63 , 49 , and 79 subjects were randomized in four trials of 9-beam lasercomb treatment in female subjects , 12-beam lasercomb treatment in female subjects , 7-beam lasercomb treatment in male subjects , and 9 - and 12-beam lasercomb treatment in male subjects , compared with the sham device , respectively .
-RESULTS	Nineteen female and 25 male subjects were lost to follow-up .
-RESULTS	Among the remaining 122 female and 103 male subjects in the efficacy analysis , the mean terminal hair count at 26 weeks increased from baseline by 20.2 , 20.6 , 18.4 , 20.9 , and 25.7 per cm2 in 9-beam lasercomb-treated female subjects , 12-beam lasercomb-treated female subjects , 7-beam lasercomb-treated male subjects , and 9 - and 12-beam lasercomb-treated male subjects , respectively , compared with 2.8 ( p < 0.0001 ) , 3.0 ( p < 0.0001 ) , 1.6 ( p = 0.0017 ) , 9.4 ( p = 0.0249 ) , and 9.4 ( p = 0.0028 ) in sham-treated subjects ( 95 % confidence interval ) .
-RESULTS	The increase in terminal hair density was independent of the age and sex of the subject and the lasercomb model .
-RESULTS	Additionally , a higher percentage of lasercomb-treated subjects reported overall improvement of hair loss condition and thickness and fullness of hair in self-assessment , compared with sham-treated subjects .
-RESULTS	No serious adverse events were reported in any subject receiving the lasercomb in any of the four trials .
-CONCLUSIONS	We observed a statistically significant difference in the increase in terminal hair density between lasercomb - and sham-treated subjects .
-CONCLUSIONS	No serious adverse events were reported .
-CONCLUSIONS	Our results suggest that low-level laser treatment may be an effective option to treat pattern hair loss in both men and women .
-CONCLUSIONS	Additional studies should be considered to determine the long-term effects of low-level laser treatment on hair growth and maintenance , and to optimize laser modality .
-
-###25298016
-OBJECTIVE	Primary-care ( PC ) settings may be an opportune place to deliver obesity interventions .
-OBJECTIVE	Scalable interventions utilizing motivational interviewing ( MI ) , supported by Internet resources , may overcome obstacles to effective obesity treatment dissemination .
-OBJECTIVE	This study was a randomized controlled trial testing two Web-supported interventions , motivational interviewing ( MIC ) and nutrition psychoeducation ( NPC ) , an attention-control intervention , in comparison with usual care ( UC ) .
-METHODS	Eighty-nine overweight/obese patients , with and without binge eating disorder ( BED ) , were randomly assigned to MIC , NPC , or UC for 3 months in PC .
-METHODS	Patients were assessed independently at post-treatment and at 3-month follow-up .
-RESULTS	Weight , triglyceride levels , and depression scores decreased significantly in NPC when compared to UC but not MIC ; UC and MIC did not differ significantly .
-RESULTS	Weight loss results maintained at 3-month follow-up : approximately 25 % MIC and NPC patients achieved at least 5 % weight loss which did not differ by BED status .
-RESULTS	Fidelity ratings were high and treatment adherence was associated with weight loss .
-CONCLUSIONS	This is the first randomized controlled trial in PC testing MI for weight loss to include an attention-control intervention ( NPC ) .
-CONCLUSIONS	NPC , but not MIC , showed a consistent pattern of superior benefits relative to UC .
-CONCLUSIONS	BED status was not associated , but treatment adherence was associated , with weight loss outcomes .
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-###25062740
-BACKGROUND	Miller laryngoscope blades are preferred for laryngoscopy in infants and children < 2 yr of age .
-BACKGROUND	Despite their long history , the laryngeal view with the Miller blade size 1 has never been compared with that with the Macintosh ( MAC ) blade in children .
-BACKGROUND	This prospective , single-blinded , randomized study was designed to compare the laryngeal views with the size 1 Miller and MAC blades in children < 2 yr .
-METHODS	With IRB approval , 50 ASA I and II children < 2 yr undergoing elective surgery were enrolled .
-METHODS	After an inhalation induction and neuromuscular block with i.v. rocuronium 0.5 mg kg ( -1 ) , two laryngeal views were obtained with a single blade ( Miller or MAC ) in each child : one lifting the epiglottis and another lifting the tongue base .
-METHODS	The best laryngeal views in each blade position were photographed with a SONY ( ) Cyber-shot camera and rated by a blinded anaesthesiologist using the percentage of glottic opening scale .
-RESULTS	The scores with the Miller blade lifting the epiglottis and the MAC blade lifting the tongue base were similar .
-RESULTS	The scores with the Miller blade lifting the epiglottis and the tongue base were similar .
-RESULTS	The scores for the MAC blade lifting the tongue base were greater than those lifting the epiglottis ( 95 % confidence interval : 7.6-26 .8 ) ( P = 0.0004 ) .
-CONCLUSIONS	In infants and children < 2 yr of age , optimal laryngeal views may be obtained with either the Miller size 1 blade lifting the epiglottis or with the Miller or MAC blades lifting the tongue base .
-BACKGROUND	NCT01717872 at Clinical Trials.gov .
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-###25421390
-OBJECTIVE	To study the predictive value of biphasic ST-events for interventions for suspected fetal distress and adverse neonatal outcome , when using ST-analysis of the fetal electrocardiogram ( FECG ) for intrapartum fetal monitoring .
-METHODS	Prospective cohort study .
-METHODS	Three academic hospitals in Sweden .
-METHODS	Women in labor with a high-risk singleton fetus in cephalic position beyond 36weeks of gestation .
-METHODS	In women in labor who were monitored with conventional cardiotocography , ST-waveform analysis was recorded and concealed .
-METHODS	Traces with biphasic ST-events of the FECG ( index ) were compared with traces without biphasic events of the FECG .
-METHODS	The ability of biphasic events to predict interventions for suspected fetal distress and adverse outcome was assessed using univariable and multivariable logistic regression analyses .
-METHODS	Interventions for suspected fetal distress and adverse outcome ( defined as presence of metabolic acidosis ( i.e. umbilical cord pH < 7.05 and base deficit in extracellular fluid > 12mmol ) , umbilical cord pH < 7.00 , 5-min Apgar score < 7 , admittance to neonatal intensive care unit or perinatal death ) .
-RESULTS	Although the presence of biphasic events of the FECG was associated with more interventions for fetal distress and an increased risk of adverse outcome compared with cases with no biphasic events , the presence of significant ( i.e. intervention advised according to cardiotocography interpretation ) biphasic events showed no independent association with interventions for fetal distress [ odds ratio ( OR ) 1.71 , 95 % confidence interval ( CI ) 0.65-4 .50 ] or adverse outcome ( OR 1.96 , 95 % CI 0.74-5 .24 ) .
-CONCLUSIONS	The presence of significant biphasic events did not discriminate in the prediction of interventions for fetal distress or adverse outcome .
-CONCLUSIONS	Therefore , biphasic events in relation to ST-analysis monitoring during birth should be omitted if future studies confirm our findings .
-
-###24312277
-BACKGROUND	In HIV-infected children , viral diversity tends to increase with age in the absence of antiretroviral treatment ( ART ) .
-BACKGROUND	We measured HIV diversity in African children ( ages 6-36 months ) enrolled in a randomized clinical trial comparing two ART regimens ( Cohort I of the P1060 trial ) .
-BACKGROUND	Children in this cohort were exposed to single dose nevirapine ( sdNVP ) at birth .
-METHODS	HIV diversity was measured retrospectively using a high resolution melting ( HRM ) diversity assay .
-METHODS	Samples were obtained from 139 children at the enrollment visit prior to ART initiation .
-METHODS	Six regions of the HIV genome were analyzed : two in gag , one in pol , and three in env .
-METHODS	A single numeric HRM score that reflects HIV diversity was generated for each region ; composite HRM scores were also calculated ( mean and median for all six regions ) .
-RESULTS	In multivariable median regression models using backwards selection that started with demographic and clinical variables , older age was associated with higher HRM scores ( higher HIV diversity ) in pol ( P = 0.005 ) and with higher mean ( P = 0.014 ) and median ( P < 0.001 ) HRM scores .
-RESULTS	In multivariable models adjusted for age , pre-treatment HIV viral load , pre-treatment CD4 % , and randomized treatment regimen , higher HRM scores in pol were associated with shorter time to virologic suppression ( P = 0.016 ) and longer time to study endpoints ( virologic failure [ VF ] , VF/death , and VF/off study treatment ; P < 0.001 for all measures ) .
-CONCLUSIONS	In this cohort of sdNVP-exposed , ART-nave African children , higher levels of HIV diversity in the HIV pol region prior to ART initiation were associated with better treatment outcomes .
-
-###24280041
-BACKGROUND	Asymmetric dimethylarginine ( ADMA ) , an endogenous inhibitor of nitric oxide synthase , increase with advancing age and menopausal status .
-BACKGROUND	ADMA plays a role in endothelial dysfunction and increasing arterial stiffness .
-BACKGROUND	Regular aerobic exercise has a positive effect on arterial function ( i.e. , arterial compliance ) .
-BACKGROUND	This study investigated the effects of aerobic exercise training on plasma ADMA concentrations and arterial compliance in postmenopausal women .
-METHODS	Thirty postmenopausal women were divided into 2 groups : an exercise group ( n = 20 ) and a control group ( n = 10 ) .
-METHODS	Subjects in the exercise group completed 12 weeks of aerobic exercise training ( 65 % -80 % of maximal heart rate , 40-60 min/day , 3-6 days/week ) .
-METHODS	Before and after each intervention , plasma ADMA concentrations and carotid arterial compliance were measured in all participants .
-RESULTS	The baseline plasma ADMA concentrations , carotid arterial compliance , and most other key dependent variables did not differ between the 2 groups .
-RESULTS	In the exercise group , carotid arterial compliance significantly increased after exercise intervention ( P < 0.01 ) , and plasma ADMA concentrations significantly decreased ( P < 0.05 ) .
-RESULTS	In addition , changes in carotid arterial compliance after the exercise intervention were inversely correlated with changes in plasma ADMA concentrations ( r = -0.367 ; P < 0.05 ) .
-CONCLUSIONS	We demonstrated that aerobic exercise training significantly decreased plasma ADMA concentrations with increase in carotid arterial compliance in postmenopausal women .
-CONCLUSIONS	These results suggest that reduction in ADMA may play an important role in the aerobic exercise training-induced increase in arterial compliance .
-
-###25310525
-BACKGROUND	Persistent disparities in access and quality of mental health care for Latinos indicate a need for evidence-based , culturally adapted , and outside-the-clinic-walls treatments .
-OBJECTIVE	Evaluate treatment effectiveness of telephone ( ECLA-T ) or face-to-face ( ECLA-F ) delivery of a 6-8 session cognitive behavioral therapy and care management intervention for low-income Latinos , as compared to usual care for depression .
-METHODS	Multisite randomized controlled trial .
-METHODS	Eight community health clinics in Boston , Massachusetts and San Juan , Puerto Rico .
-METHODS	257 Latino patients recruited from primary care between May 2011 and September 2012 .
-METHODS	The primary outcome was severity of depression , assessed with the Patient Health Questionnaire-9 and the Hopkins Symptom Checklist-20 .
-METHODS	The secondary outcome was functioning over the previous 30 days , measured using the World Health Organization Disability Assessment Schedule ( WHO-DAS 2.0 ) .
-RESULTS	Both telephone and face-to-face versions of the Engagement and Counseling for Latinos ( ECLA ) were more effective than usual care .
-RESULTS	The effect sizes of both intervention conditions on Patient Health Questionnaire-9 were moderate when combined data from both sites are analyzed ( 0.56 and 0.64 for face-to-face and telephone , respectively ) .
-RESULTS	Similarly , effect sizes of ECLA-F and ECLA-T on the Hopkins Symptom Checklist were quite large in the Boston site ( 0.64 and 0.73 .
-RESULTS	respectively ) but not in Puerto Rico ( 0.10 and 0.03 ) .
-CONCLUSIONS	The intervention appears to help Latino patients reduce depressive symptoms and improve functioning .
-CONCLUSIONS	Of particular importance is the higher treatment initiation for the telephone versus face-to-face intervention ( 89.7 % vs. 78.8 % ) , which suggests that telephone-based care may improve access and quality of care .
-
-###25146756
-BACKGROUND	Vomiting is a common complication associated with the use of hydromorphine for pre-emptive analgesia in dogs .
-BACKGROUND	The ideal anti-emetic protocol for prevention of this complication has not been established .
-OBJECTIVE	Maropitant administered concurrently or before hydromorphone would reduce the incidence of vomiting , signs of nausea , ptyalism , and increased panting compared to administration of acepromazine or a 0.9 % saline control .
-METHODS	Sixty mixed-breed female dogs scheduled for ovariohysterectomy .
-METHODS	Randomized , blinded , placebo-controlled experimental study .
-METHODS	Dogs were assigned to 4 experimental groups with 15 dogs per group .
-METHODS	All groups received 0.2 mg/kg of hydromorphone IM .
-METHODS	Group `` Control '' received 0.1 mL/kg saline SC 30-45 minutes before hydromorphone , group `` Marop1 '' received 1 mg/kg maropitant SC 30-45 minutes before hydromorphone , group `` Ace '' received 0.02 mg/kg IM acepromazine 30-45 minutes before hydromorphone , and group `` Marop2 '' received 1 mg/kg SC maropitant concurrently with hydromorphone .
-METHODS	A trained and blinded observer documented adverse events from the time hydromorphone was administered until the time dogs were induced for surgery .
-RESULTS	Marop1 had significantly less vomiting ( 0 % ) compared to Control ( 87 % ; P < .01 ) and Ace ( 53 % ; P < .01 ) .
-RESULTS	Marop2 had significantly less vomiting ( 27 % ) compared to Control ( P < .01 ) .
-RESULTS	Marop1 had significantly greater incidence of ptyalism ( 73 % ) compared to Ace ( P < .01 ; 20 % ) .
-RESULTS	Ace showed significantly less panting ( 33 % ) compared to Marop2 ( 93 % ; P < .01 ) .
-CONCLUSIONS	In healthy dogs , maropitant citrate administered before hydromorphone significantly decreases the incidence of vomiting in dogs but does not improve signs of nausea , ptyalism , or increased panting .
-
-###24292111
-BACKGROUND	Sentinel lymph node biopsy alone has become an acceptable alternative to elective axillary lymph node dissection in patients with clinically node-negative early-stage breast cancer .
-BACKGROUND	Approximately 70 percent of the patients undergoing breast surgery develop side effects caused by the axillary lymph node dissection ( axillary pain , shoulder stiffness , lymphedema and paresthesias ) .
-OBJECTIVE	The current standard treatment is to perform completion axillary lymph node dissection in patients with positive sentinel lymph node biopsy .
-OBJECTIVE	However , randomized clinical trials of axillary dissection versus axillary irradiation failed to show survival differences between the two types of axillary treatment .
-OBJECTIVE	The National Institute of Oncology , Budapest conducted a single centre randomized clinical study .
-OBJECTIVE	The OTOASOR ( Optimal Treatment of the Axilla - Surgery or Radiotherapy ) trial compares completion axillary lymph node dissection to axillary nodal irradiation in patients with sentinel lymph node-positive primary invasive breast cancer .
-METHODS	Patients with primary invasive breast cancer ( clinically lymph node negative and less than or equal to 3 cm in size ) were randomized before surgery for completion axillary lymph node dissection ( arm A-standard treatment ) or axillary nodal irradiation ( arm B-investigational treatment ) .
-METHODS	Sentinel lymph node biopsy was performed by the radio-guided method .
-METHODS	The use of blue-dye was optional .
-METHODS	Sentinel lymph nodes were investigated with serial sectioning at 0.5 mm levels by haematoxylin and eosin staining .
-METHODS	In the investigational treatment arm patients received 50Gy axillary nodal irradiation instead of completion axillary lymph node dissection .
-METHODS	Adjuvant treatment was recommended and patients were followed up according to the actual institutional guidelines .
-RESULTS	Between August 2002 and June 2009 , 2106 patients were randomized for completion axillary lymph node dissection ( 1054 patients ) or axillary nodal irradiation ( 1052 patients ) .
-RESULTS	The two arms were well balanced according to the majority of main prognostic factors .
-RESULTS	Sentinel lymph node was identified in 2073 patients ( 98.4 % ) and was positive in 526 patients ( 25.4 % ) .
-RESULTS	Fifty-two sentinel lymph node-positive patients were excluded from the study ( protocol violation , patient 's preference ) .
-RESULTS	Out of the remaining 474 patients , 244 underwent completion axillary lymph node dissection and 230 received axillary nodal irradiation according to randomization .
-RESULTS	The mean length of follow-up to the first event and the mean total length of follow-up were 41.9 and 43.3 months , respectively , and there were no significant differences between the two arms .
-RESULTS	There was no significant difference in axillary recurrence between the two arms ( 0.82 % in arm A and 1.3 % in arm B ) .
-RESULTS	There was also no significant difference in terms of overall survival between the arms at the early stage follow-up .
-CONCLUSIONS	The authors conclude that after a mean follow-up of more than 40 months axillary nodal irradiation may control the disease in the axilla as effectively as completion axillary lymph node dissection and there was also no difference in terms of overall survival .
-
-###24902040
-BACKGROUND	There is no consensus concerning the most effective type of facilitator to promote healthy sexual behaviours in interventions targeting adolescents .
-OBJECTIVE	To evaluate the facilitator 's effect on the implementation of the COMPAS programme ( Spanish acronym for Skills for Adolescents with Healthy Sexuality ) , a school-based HIV prevention protocol .
-METHODS	Participants were 832 Spanish scholars aged 14 to 18 .
-METHODS	Fifteen schools were randomly assigned to one of the three following schemes : COMPAS delivered by experts only ; the same programme administered by experts and peers ; or a control group , not exposed to any intervention .
-RESULTS	The experts achieved an improvement in HIV knowledge and attitudes towards HIV and condom use ; however , experts associated to peers only succeeded in increasing HIV knowledge .
-RESULTS	The effect size of the changes indicated a greater positive change in the programme when applied by experts than by experts and peers .
-CONCLUSIONS	The participation of peers as co-facilitators did not increase the efficacy of a programme delivered by experts to Spanish adolescents .
-CONCLUSIONS	Education delivered by experts was the most effective modality for reducing sexual risk .
-CONCLUSIONS	COMPAS is the only Spanish programme targeting the promotion of safer sex behaviours in adolescents whose efficacy has been evaluated with different health agents in Spain .
-
-###25223180
-OBJECTIVE	To observe the therapeutic effect of a drug pair of Radix Astragali and Rehmanniae Radix combined with glucocorticoid ( GC ) in treating lupus nephritis ( LN ) patients and its influence on some experimental indices .
-METHODS	Totally 52 LN patients were randomly assigned to the treatment group ( treated by routine Western medicine and a drug pair of Radix Astragali and Rehmanniae Radix , 25 cases ) and the control group ( treated by Western medicine , mainly by GC and cyclophosphamide , 27 cases ) .
-METHODS	All patients received 6-month therapy .
-METHODS	The GC dosage , the withdrawal and reduction dosage of GC , clinical efficacy , systemic lupus erythematosus disease activity index ( SLEDAI ) score , adverse reactions , and laboratory indicators were recorded .
-RESULTS	( 1 ) All patients got relieved to some degree with the dosage of GC reduced .
-RESULTS	The total withdrawal and reduction dosage of GC was slightly higher in the treatment group than in the control group [ ( 50.23 + / - 12.43 ) mg vs ( 48.76 + / - 13.61 ) mg , P > 0.05 ] .
-RESULTS	Besides , the prednisone dosage in the treatment group was lower than that in the control group , but without statistical difference ( P > 0.05 ) .
-RESULTS	The ratio of patients in need of adding prednisone for aggravating disease was 24.0 % , significantly lower than that in the control group ( 44.44 % , P < 0.05 ) .
-RESULTS	( 2 ) There was no statistical difference in the SLEDAI score , inflammatory indicators , liver and renal functions , blood electrolytes , blood glucose , blood and urine routines between the two groups ( P > 0.05 ) .
-RESULTS	The 24-h urinary protein count was ( 1.06 + / - 0.22 ) g/L in the treatment group , obviously lower than that in the control group ( 1.43 + / - 0.55 g/L , P < 0.05 ) .
-RESULTS	( 3 ) There was no statistical difference in the incidence rate of infection , gastrointestinal hemorrhage , psychoneuroses , Cushing 's syndrome , cardiovascular anomalies , and femoral head necrosis between the two groups ( P > 0.05 ) .
-RESULTS	But the incidence of adverse reactions such as insomnia , tidal fever , spontaneous sweat , and obesity was less in the treatment group than in the control group ( P < 0.05 ) .
-CONCLUSIONS	Using a drug pair of Radix Astragali and Rehmanniae Radix combined with GC in treating LN could withdraw the dosage of GC and relieve symptoms it induced .
-CONCLUSIONS	It was advantageous in reducing the dosage of GC and stabilizing patients ' conditions .
-
-###25424297
-OBJECTIVE	To evaluate the efficacy and side-effects of fentanyl and sufentanil combined with hyperbaric spinal bupivacaine in elective cesarean section .
-METHODS	A prospective , randomized , double-blind study with 64 term parturients , distributed into 2 groups according to the opioid combined with hyperbaric bupivacaine 0.5 % ( 10mg ) : GF - fentanyl ( 25 g ) and GS - sufentanil ( 5.0 g ) .
-METHODS	The latency and maximum sensory block level ; degree and duration of motor block ; duration and quality of analgesia ; maternal-fetal repercussions were evaluated .
-METHODS	This was an intention-to-treat analysis with a 5 % significance level .
-RESULTS	The latency period , maximum sensory block level , motor block degree and perioperative analgesia were similar in both groups .
-RESULTS	Motor block and analgesia had a longer duration in the sufentanil group .
-RESULTS	Maternal adverse effects and neonatal repercussions were similar .
-RESULTS	The incidence of hypotension was higher in the fentanyl group .
-RESULTS	In both groups , there was a predominance of patients who were awake and either calm or sleepy .
-CONCLUSIONS	The addition of fentanyl and sufentanil to hyperbaric subarachnoid bupivacaine was shown to be effective for the performance of cesarean section , and safe for the mother and fetus .
-CONCLUSIONS	Analgesia was more prolonged with sufentanil .
-
-###24888810
-OBJECTIVE	Figitumumab ( CP-751 ,871 ) , a fully human immunoglobulin G2 monoclonal antibody , inhibits the insulin-like growth factor 1 receptor ( IGF-1R ) .
-OBJECTIVE	Our multicenter , randomized , phase III study compared figitumumab plus chemotherapy with chemotherapy alone as first-line treatment in patients with advanced non-small-cell lung cancer ( NSCLC ) .
-METHODS	Patients with stage IIIB/IV or recurrent NSCLC disease with nonadenocarcinoma histology received open-label figitumumab ( 20 mg/kg ) plus paclitaxel ( 200 mg/m ( 2 ) ) and carboplatin ( area under the concentration-time curve , 6 mg min/mL ) or paclitaxel and carboplatin alone once every 3 weeks for up to six cycles .
-METHODS	The primary end point was overall survival ( OS ) .
-RESULTS	Of 681 randomly assigned patients , 671 received treatment .
-RESULTS	The study was closed early by an independent Data Safety Monitoring Committee because of futility and an increased incidence of serious adverse events ( SAEs ) and treatment-related deaths with figitumumab .
-RESULTS	Median OS was 8.6 months for figitumumab plus chemotherapy and 9.8 months for chemotherapy alone ( hazard ratio [ HR ] , 1.18 ; 95 % CI , 0.99 to 1.40 ; P = .06 ) ; median progression-free survival was 4.7 months ( 95 % CI , 4.2 to 5.4 ) and 4.6 months ( 95 % CI , 4.2 to 5.4 ) , respectively ( HR , 1.10 ; P = .27 ) ; the objective response rates were 33 % and 35 % , respectively .
-RESULTS	The respective rates of all-causality SAEs were 66 % and 51 % ; P < .01 ) .
-RESULTS	Treatment-related grade 5 adverse events were also more common with figitumumab ( 5 % v 1 % ; P < .01 ) .
-CONCLUSIONS	Adding figitumumab to standard chemotherapy failed to increase OS in patients with advanced nonadenocarcinoma NSCLC .
-CONCLUSIONS	Further clinical development of figitumumab is not being pursued .
-
-###25249234
-BACKGROUND	Postprandial hyperglycemia is a known risk factor for the development of several health disorders including type 2 diabetes , obesity , oxidative stress , and cardiovascular diseases .
-BACKGROUND	One encouraging approach for a better control of postprandial glycemia is to reduce carbohydrate digestion .
-BACKGROUND	Cinnamon extracts have been known for managing blood glucose .
-BACKGROUND	However , their effects on inhibiting digestion of carbohydrate have been poorly analyzed to date .
-BACKGROUND	The aim of this study was to investigate the acute effect of a specific Ceylon cinnamon hydro-alcoholic extract ( CCE ) on carbohydrate digestion and post-meal blood glucose reduction .
-METHODS	In vitro enzymatic assays and in vivo starch tolerance tests in rats were designed as preclinical assays .
-METHODS	Then , a randomized , double-blind , placebo-controlled , cross-over clinical trial was conducted in 18 healthy female and male volunteers .
-METHODS	Following the intake of 1 g of CCE , the subjects ate a standardized meal .
-METHODS	Blood samples were collected during the 2 hours following the meal to measure glucose and insulin concentrations .
-METHODS	Areas under the curves were calculated and statistical differences between the CCE and placebo groups were analyzed using the Mann Whitney-Wilcoxon test .
-RESULTS	CCE has demonstrated in the in vitro study that it inhibited pancreatic alpha-amylase activity with an IC50 of 25 g/mL .
-RESULTS	In the in vivo study , CCE was shown to acutely reduce the glycemic response to starch in a dose-dependent manner in rats .
-RESULTS	This effect was significant from the dose of 12.5 mg/kg of body weight .
-RESULTS	In both , the in vitro and in vivo studies , the hydro-alcoholic extract has shown to be more efficacious than the aqueous extract .
-RESULTS	In the human clinical trial , 1 g of CCE lowered the area under the curve of glycemia between 0 and 120 min by 14.8 % ( P = 0.15 ) and between 0 and 60 min by 21.2 % ( P < 0.05 ) compared to the placebo .
-RESULTS	This effect occurred without stimulating insulin secretion .
-RESULTS	No adverse effects were reported .
-CONCLUSIONS	These results suggest that Ceylon cinnamon hydro-alcoholic extract ( CCE ) may provide a natural and safe solution for the reduction of postprandial hyperglycemia and therefore help to reduce the risks of developing metabolic disorders .
-BACKGROUND	ClinicalTrials.gov NCT02074423 ( 26/02/2014 ) .
-
-###24229434
-OBJECTIVE	To compare the performance of voluminous benign prostatic hyperplasia patients who have received laparoscopic simple prostatectomy ( LSP ) with the patients who have received bipolar transurethral resection of the prostate ( B-TURP ) in their perioperative and 3-year follow-up period .
-METHODS	Ninety patients with prostate volumes > 80mL ( range 80-130mL ) were randomly assigned to either LSP or B-TURP surgery type .
-METHODS	The patients were followed up at 1 , 3 , 6 , 12 , 24 , and 36 months postoperatively .
-METHODS	Perioperative and follow-up characteristics were then recorded and compared .
-RESULTS	More blood loss , greater resected adenoma volume , and shorter catheterization duration were recorded in LSP group than that of B-TURP group ( 140.181.5 vs 93.154.0 mL ; 65.313.8 vs 49.012.7 mL ; 3.31.2 vs 3.81.0 days ; p < 0.05 ) .
-RESULTS	None of the patients in LSP group reported complications out of 30 days , while 1 case of urethral stricture , 36 cases of retrograde ejaculation , 1 case of bladder neck contracture , and 2 cases of recurrence were recorded in B-TURP group .
-RESULTS	At 1 , 3 , 6 , and 12 months postoperatively , there were no significant differences in terms of postvoid residual urine volume , maximal urinary flow rate ( Qmax ) , and International Prostate Symptom Score between the two groups ( p > 0.05 ) .
-RESULTS	In contrast , the differences became significant at 24 and 36 months ( p < 0.05 ) .
-CONCLUSIONS	Compared with B-TURP , LSP with Madigan technique is accompanied by less residual adenoma , shorter catheterization time , and more blood loss .
-CONCLUSIONS	Further , the risk of late complications is lower with LSP and , in terms of functional outcomes , LSP appears to be better than B-TURP beyond 2 years .
-
-###25749595
-BACKGROUND	Mind-body therapies such as Tai Chi are widely used by breast cancer survivors , yet effects on inflammation are not known .
-BACKGROUND	This study hypothesized that Tai Chi Chih ( TCC ) would reduce systemic , cellular , and genomic markers of inflammation as compared with cognitive behavioral therapy for insomnia ( CBT-I ) .
-METHODS	In this randomized trial for the treatment of insomnia , 90 breast cancer survivors with insomnia were assigned to TCC or CBT-I for 2-hour sessions weekly for 3 months .
-METHODS	At baseline and postintervention , blood samples were obtained for measurement of C-reactive protein and toll-like receptor-4-activated monocyte production of interleukin-6 ( IL-6 ) and tumor necrosis factor - ( TNF ) , with a random subsample ( n = 48 ) analyzed by genome-wide transcriptional profiling .
-RESULTS	Levels of C-reactive protein did not change in the TCC and CBT-I groups .
-RESULTS	Levels of toll-like receptor-4-activated monocyte production of IL-6 and TNF combined showed an overall reduction in TCC versus CBT-I ( P < .02 ) , with similar effects for IL-6 ( P = .07 ) and TNF ( P < .05 ) alone .
-RESULTS	For genome-wide transcriptional profiling of circulating peripheral blood mononuclear cells , expression of genes encoding proinflammatory mediators showed an overall reduction in TCC versus CBT-I ( P = .001 ) .
-RESULTS	TELiS promoter-based bioinformatics analyses implicated a reduction of activity of the proinflammatory transcription factor , nuclear factor-B , in structuring these differences .
-CONCLUSIONS	Among breast cancer survivors with insomnia , 3 months of TCC reduced cellular inflammatory responses , and reduced expression of genes encoding proinflammatory mediators .
-CONCLUSIONS	Given the link between inflammation and cancer , these findings provide an evidence-based molecular framework to understand the potential salutary effects of TCC on cancer survivorship .
-
-###25420889
-OBJECTIVE	Ecabet sodium ( ES ) is a new non-systemic anti-ulcer agent belonging to the category of gastroprotective agents .
-OBJECTIVE	In this study we aimed to compare the efficacy of a combination therapy with lansoprazole ( LS ) followed by ES with LS alone in treating endoscopic submucosal dissection ( ESD ) - induced iatrogenic gastric ulcers .
-METHODS	Patients diagnosed with gastric adenomas or early gastric cancer were randomly divided into either the LS group ( 30mg once daily for 4 weeks ; n = 45 ) or the LS+ES group ( LS 30mg once daily for one week followed byES 1500mg twice daily for 3 weeks ; n = 45 ) .
-METHODS	Four weeks after ESD , a follow-up endoscopy was conducted to evaluate the proportions of ulcer reduction and ulcer stages in the two groups .
-RESULTS	In all , 79 patients were included in the final analyses .
-RESULTS	Both treatment modalities were well-tolerated in most patients , with a drug compliance of over 80 % .
-RESULTS	There were no significant differences between the two groups in terms of the proportions of ulcer reduction ( 0.95030.1215 in the LS group vs 0.91920.0700 in the LS+ES group , P = 0.169 ) or ulcer stage ( P = 0.446 ) .
-RESULTS	The prevalence of adverse events related to drugs and bleeding were also similar between the two groups .
-CONCLUSIONS	Sequential therapy with LS+ES is as effective as LS alone against ESD-induced gastric ulcers .
-
-###24997178
-OBJECTIVE	To investigate the efficacy and safety of the MGDRx EyeBag ( The Eyebag Company , Halifax , UK ) eyelid warming device .
-METHODS	Twenty-five patients with confirmed meibomian gland dysfunction ( MGD ) - related evaporative dry eye were enrolled into a randomised , single masked , contralateral clinical trial .
-METHODS	Test eyes received a heated device ; control eyes a non-heated device for 5min twice a day for 2weeks .
-METHODS	Efficacy ( ocular symptomology , non-invasive break-up time , lipid layer thickness , osmolarity , meibomian gland dropout and function ) and safety ( visual acuity , corneal topography , conjunctival hyperaemia and staining ) measurements were taken at baseline and follow-up .
-METHODS	Subsequent patient device usage and ocular comfort was ascertained at 6months .
-RESULTS	Differences between test and control eyes at baseline were not statistically significant for all measurements ( p > 0.05 ) .
-RESULTS	After 2weeks , statistically significant improvements occurred in all efficacy measurements in test eyes ( p < 0.05 ) .
-RESULTS	Visual acuity and corneal topography were unaffected ( p > 0.05 ) .
-RESULTS	All patients maintained higher ocular comfort after 6months ( p < 0.05 ) , although the benefit was greater in those who continued usage 1-8 times a month ( p < 0.001 ) .
-CONCLUSIONS	The MGDRx EyeBag is a safe and effective device for the treatment of MGD-related evaporative dry eye .
-CONCLUSIONS	Subjective benefit lasts at least 6months , aided by occasional retreatment .
-BACKGROUND	NCT01870180 .
-
-###25943440
-OBJECTIVE	Complex regional pain syndrome type I ( CPRS I ) , is a complex of symptoms characterized by diffuse pain usually with associated swelling , vasomotor instability , and severe functional impairment of the affected extremity in stroke patients .
-OBJECTIVE	Pain is a prominent feature and is often refractory to variety of treatment .
-METHODS	To investigate the clinical , functional , and psychosocial effects of upper extremity aerobic exercise ( UEAE ) and compare the effect of aerobic exercise with that of conventional physiotherapy in patients with CPRS type I following stroke as a randomized controlled assesor blinded 4 week-study .
-METHODS	A total of 52 inpatients with stroke [ mean age : 65.95 8.7 ( min .
-METHODS	= 53 , max .
-METHODS	= 80 ) years , and the mean age of the control group was 67.5011.2 years ] , all within 6 months post-stroke and diagnosed with CPRS I.
-METHODS	The UEAE program consisted of an arm crank ergometer ( 10 W/min ) , in addition to a conventional physiotherapy ( whirlpool , TENS , retrograd massage ) .
-METHODS	Primary outcome measures were CPRS clinical determinants ( pain , hyperalgesia , allodynia , and autonomic abnormalities ) secondary outcome measures were functional independence measure ( FIM ) , Nottingham Health Profile ( NHP ) , and Beck Depression Scale scores that were performed at 0 month ( baseline ) and 4 weeks ( post-treatment ) .
-RESULTS	In UEAE group , patients reported significant pain relief ( 89.9 % ) and significant decline in CRPS signs and symptoms .
-RESULTS	The mean change in pain at shoulder , pain at the hand as well as and NHP and BDS scores between groups were statistically significant ( P < 0.05 ) .
-CONCLUSIONS	UEAE made an excellent improvement in the symptoms and signs of CRPS I. Combined treatment of conventional physiotherapy and aerobic exercises may be an excellent synthesis for this syndrome in these patients .
-
-###25765827
-OBJECTIVE	to evaluate the efficacy of Berberis aristata/Silybum marianum ( Berberol ( ) ) in a sample of dyslipidemic patients intolerant to statins at high dosages in a randomized , double blind , placebo-controlled clinical trial .
-METHODS	we enrolled 175 euglycemic , dyslipidemic subjects , intolerant to statins at high dosages .
-METHODS	During the run-in period , statins were stopped for 1 month , then they were re-introduced at the half of the previously taken dose .
-METHODS	After that , patients were randomized to placebo or Berberol ( ) , 1 tablet during the lunch and 1 tablet during the dinner , for 6 months .
-METHODS	Anthropometric , metabolic and inflammatory parameters were assessed at randomization , at 3 and 6 months .
-RESULTS	fasting plasma glucose , insulin , and HOMA-index levels were reduced by Berberol ( ) , but not by placebo ; moreover they were lower than the ones recorded with placebo .
-RESULTS	Total cholesterol , LDL-C , triglycerides , and myeloperoxidase did not change after 6 months since the reduction of statin dosage and the introduction of Berberol ( ) , while they increased in the placebo group , and were higher compared to the ones obtained with active treatment .
-RESULTS	No patients had serious adverse events in both groups .
-CONCLUSIONS	our study displays the rationale of the combination of Berberol ( ) and a reduced dosage of statin for the treatment of hyperlipidemia in patients intolerant to statins at high dosage .
-
-###25025247
-BACKGROUND	Postoperative ileus ( POI ) , a common postoperative complication , increases length of stay and costs .
-BACKGROUND	Although bowel rest and delayed oral intake were once thought to help prevent POI , newer evidence shows that chewing gum can be beneficial .
-BACKGROUND	METHODS -- LITERATURE SEARCH : The literature was searched for the terms ileus , gum , chewing , and gum chewing for 2006 to 2013 .
-METHODS	All prospective randomized controlled trials comparing gum chewing in adults with a control treatment after abdominal surgery ( except cesarean section ) were included ; an outcome measure was required as a dependent variable .
-RESULTS	Seven primary research studies from around the world were gathered .
-RESULTS	Across all studies , patients in the gum-chewing experimental group both passed flatus and defecated before those in the non-gum-chewing control group .
-RESULTS	Where length of stay was studied , patients in all but one experimental group were in the hospital for less time .
-CONCLUSIONS	These included small sample sizes , lack of blinding in all but one study , differences in standards of care among hospitals and countries represented , unspecified types of gum , and variable timing and frequency of gum chewing among studies .
-CONCLUSIONS	Patients who chewed gum postoperatively had less POI , passed flatus sooner , had an earlier bowel movement and a shorter length of stay , and were more satisfied .
-CONCLUSIONS	Gum chewing is recommended as adjunctive therapy to reduce postoperative POI .
-
-###24887185
-BACKGROUND	Carpal tunnel syndrome is known as the most common entrapment neuropathy .
-BACKGROUND	Conservative treatments can not reduce the symptomatic severity satisfactorily ; therefore , effectiveness of Linum usitatissimum L. ( linseed ) oil on carpal tunnel syndrome , as a complementary treatment , was evaluated in the current study .
-BACKGROUND	Linseed oil is a well-known preparation in Iranian traditional medicine and its analgesic , anti-inflammatory and anti-oxidative effects have been shown in previous studies .
-METHODS	A randomized , double-blind , placebo-controlled clinical trial was conducted .
-METHODS	One hundred patients ( 155 hands ) with idiopathic mild to moderate carpal tunnel syndrome aged between 18 and 65years old were randomized in two parallel groups .
-METHODS	These two groups were treated during 4weeks with topical placebo and linseed oil .
-METHODS	In addition , a night wrist splint was prescribed for both groups .
-METHODS	Symptomatic severity and functional status were measured using Boston Carpal Tunnel Questionnaire .
-METHODS	In addition , median sensory nerve conduction velocity , motor distal latency , sensory distal latency and compound latency as electrodiagnostic parameters were measured at baseline and after the intervention period .
-RESULTS	After the intervention , significant improvement was observed regarding Boston Carpal Tunnel Questionnaire symptomatic severity and functional status mean differences ( p < 0.001 ) in the linseed oil group compared with those in the placebo group .
-RESULTS	Also , regarding the mean differences of both groups , significant improvement of nerve conduction velocity of the median nerve was seen in the linseed oil group by a value of 2.38 m/sec ( p < 0.05 ) .
-RESULTS	However , motor distal latency and sensory distal latency of the median nerve showed no between-group significant changes ( p = 0.14 for both items ) .
-RESULTS	Finally , compound latency was improved slightly in the case group , comparing mean differences between the groups ( p < 0.05 ) .
-RESULTS	No significant adverse events were reported from using linseed oil .
-CONCLUSIONS	It seems that linseed oil could be effective in the management of mild and moderate carpal tunnel syndrome , especially in improving the severity of symptoms and functional status .
-CONCLUSIONS	In addition , its effect on electerodiagnostic parameters , especially on the nerve conduction velocity , can be considered as a valuable point .
-
-###24288164
-BACKGROUND	This study examines the importance of work in life of people with disability and then focuses on employer attitudes towards these people .
-BACKGROUND	In the light of Stone and Colella 's model , the study examines the employer attitudes and the role of variables such as type of disability , employer experience in the hiring of persons with disabilities , the description of hypothetical hirees with disabilities , the ways in which employers evaluate work performance and social acceptability , and the work tasks that they consider appropriate for workers with disability .
-METHODS	Eighty employers were randomly assigned to standard condition ( candidates with disability were presented by referring to the disability they presented ) or positive condition ( candidates were presented with reference to their strengths ) .
-RESULTS	It was found that the type of disability and its presentation influence employer attitudes .
-RESULTS	In addition , realistic and conventional tasks were considered appropriate for hirees with disabilities .
-CONCLUSIONS	Implications were discussed .
-
-###24305681
-BACKGROUND	Acute bouts of high-intensity exercise modulate peripheral appetite regulating hormones to transiently suppress hunger .
-BACKGROUND	However , the effects of physical activity on central appetite regulation have yet to be fully investigated .
-OBJECTIVE	We used functional magnetic resonance imaging ( fMRI ) to compare neural responses to visual food stimuli after intense exercise and rest .
-METHODS	Fifteen lean healthy men [ mean SD age : 22.5 3.1 y ; mean SD body mass index ( in kg/m ( 2 ) ) : 24.2 2.4 ] completed two 60-min trials-exercise ( EX ; running at 70 % maximum aerobic capacity ) and a resting control trial ( REST ) - in a counterbalanced order .
-METHODS	After each trial , an fMRI assessment was completed in which images of high - and low-calorie foods were viewed .
-RESULTS	EX significantly suppressed subjective appetite responses while increasing thirst and core-body temperature .
-RESULTS	Furthermore , EX significantly suppressed ghrelin concentrations and significantly enhanced peptide YY release .
-RESULTS	Neural responses to images of high-calorie foods significantly increased dorsolateral prefrontal cortex activation and suppressed orbitofrontal cortex ( OFC ) and hippocampus activation after EX compared with REST .
-RESULTS	After EX , low-calorie food images increased insula and putamen activation and reduced OFC activation compared with REST .
-RESULTS	Furthermore , left pallidum activity was significantly elevated after EX when low-calorie images were viewed and was suppressed when high-calorie images were viewed , and these responses correlated significantly with thirst .
-CONCLUSIONS	Exercise increases neural responses in reward-related regions of the brain in response to images of low-calorie foods and suppresses activation during the viewing of high-calorie foods .
-CONCLUSIONS	These central responses are associated with exercise-induced changes in peripheral signals related to appetite-regulation and hydration status .
-CONCLUSIONS	This trial was registered at www.clinicaltrials.gov as NCT01926431 .
-
-###24717964
-BACKGROUND	The live , attenuated Japanese encephalitis ( JE ) chimeric virus vaccine ( JE-CV ) is licensed in Thailand and Australia for prophylaxis of JE in individuals at the age of 12 months .
-BACKGROUND	JE-CV has not yet been compared with the SA14-14-2 JE vaccine , which is also licensed in Thailand .
-METHODS	In this phase 3 , observer-blinded trial , 300 children at the age of 9-18 months were randomized 1:1 to receive 1 dose of JE-CV or SA14-14-2 .
-METHODS	JE neutralizing antibody titers were assessed using PRNT50 .
-METHODS	The primary endpoint was the noninferiority of seroconversion against JE on Day 28 after JE-CV compared with SA14-14-2 , as assessed using the 95 % confidence interval of the difference between the groups .
-METHODS	Safety and reactogenicity were described in each group using conventional methods , including the reporting of solicited and unsolicited adverse events .
-RESULTS	The seroconversion rate on Day 28 was 99.2 % in each group .
-RESULTS	Noninferiority was demonstrated as the difference between the JE-CV and SA14-14-2 groups was -0.012 percentage points ( 95 % confidence interval : -3.6 to 3.6 ) , which was above the required -10 % .
-RESULTS	The seroprotection rate remained very high at Month 6 and comparable between groups , but a slight decrease was observed in the JE-CV group between Months 6 and 12 .
-RESULTS	Current recommendations for both vaccines call for a booster dose 12-24 months after primary immunization to maintain high seroprotection rates in the long term .
-RESULTS	Geometric mean titers ( GMTs ) on Day 28 after vaccination were 507 ( 1/dil ) in the JE-CV group and 370 ( 1/dil ) in the SA14-14-2 group , decreasing by 4.3-fold and 3.6-fold , respectively , to Month 6 before remaining stable to Month 12 and comparable between groups .
-RESULTS	Solicited reactions were all reported at lower rates after vaccination with JE-CV compared with SA14-14-2 .
-CONCLUSIONS	A single dose of JE-CV elicited a noninferior immune response compared with SA14-14-2 and had a satisfactory safety profile .
-
-###24624849
-OBJECTIVE	to analyze the efficiency and safety of Dexmedetomidine infusion for a short-term controlled sedation and treatment of delirium in the early postoperative period in patients after cardiac surgery .
-METHODS	open , randomized , prospective study of 28 patients undergoing surgery on the heart or main blood vessels under general anaesthesia .
-METHODS	In the early postoperative period all patients received an infusion of Dexmedetomidine ( 0.2-1 .4 microg kg ( -1 ) per hour ) for sedation .
-METHODS	The analgesia was carried out with Ketoprofen according to the protocol and Trimeperidine if VAS was > or = 3 .
-METHODS	Sedation and agitation levels were measured by Ramsay and RAAS scales , speed of awaking by Aldrete score .
-METHODS	Duration of mechanical ventilation , length of stay in ICU , need for analgesics ( VAS scale ) , type and frequency of side effects and vital signs ( Harward standart ) were recorded .
-METHODS	Type of delirium , time of onset ( days after surgery ) , dose and duration of psychomotor agitation were evaluated in patients with delirium ( n = 9 ) .
-RESULTS	Dexmedetomidine infusion in the medium therapeutic doses resulted mild or moderate sedation remaining up to 12 hours after the infusion .
-RESULTS	More than 50 % of patients had retrograde amnesia .
-RESULTS	The pain intensity did not exceed 1 point on VAS scale in 96 % of patients .
-RESULTS	23 % of patients required an additional administration of Trimeperidine .
-RESULTS	The most common side effects were bradycardia ( 39 % ) and arterial hypotension ( 36 % ) .
-RESULTS	The therapy with Dexmedetomidine provided the most optimal level of sedation compared to other combinations of drugs ( haloperidol , midazolam , propofol ) in patients with delirium according to sedation-agitation and awaking scales .
-CONCLUSIONS	Dexmedetomidine provides dose-dependent sedation and retrograde amnesia without altering the verbal contact , does not cause respiratory depression .
-CONCLUSIONS	The drug has independent analgesic effect and proved to be effective in the treatment of delirium .
-CONCLUSIONS	The most frequent side effects of Dexmedetomidine are bradycardia and arterial hypotension .
-
-###25627992
-OBJECTIVE	Fluid volume optimization guided by stroke volume measurements reduces complications of colorectal and high-risk surgeries .
-OBJECTIVE	We studied whether dehydration or a strong hemodynamic response to general anesthesia increases the probability of fluid responsiveness before surgery begins .
-METHODS	Cardiac output , stroke volume , central venous pressure and arterial pressures were measured in 111 patients before general anesthesia ( baseline ) , after induction and stepwise after three bolus infusions of 3 ml/kg of 6 % hydroxyethyl starch 130/0 .4 ( n = 86 ) or Ringer 's lactate ( n = 25 ) .
-METHODS	A subgroup of 30 patients who received starch were preloaded with 500 ml of Ringer 's lactate .
-METHODS	Blood volume changes were estimated from the hemoglobin concentration and dehydration was estimated from evidence of renal water conservation in urine samples .
-RESULTS	Induction of anesthesia decreased the stroke volume to 62 % of baseline ( mean ) ; administration of fluids restored this value to 84 % ( starch ) and 68 % ( Ringer 's ) .
-RESULTS	The optimized stroke volume index was clustered around 35-40 ml/m2/beat .
-RESULTS	Additional fluid boluses increased the stroke volume by 10 % ( a sign of fluid responsiveness ) in patients with dehydration , as suggested by a low cardiac index and central venous pressure at baseline and by high urinary osmolality , creatinine concentration and specific gravity .
-RESULTS	Preloading and the hemodynamic response to induction did not correlate with fluid responsiveness .
-RESULTS	The blood volume expanded 2.3 ( starch ) and 1.8 ( Ringer 's ) times over the infused volume .
-CONCLUSIONS	Fluid volume optimization did not induce a hyperkinetic state but ameliorated the decrease in stroke volume caused by anesthesia .
-CONCLUSIONS	Dehydration , but not the hemodynamic response to the induction , was correlated with fluid responsiveness .
-
-###24934845
-OBJECTIVE	Colorectal cancer ( CRC ) screening rates are lower among Latinos and people living in poverty .
-OBJECTIVE	Fecal occult blood testing ( FOBT ) is one recommended screening modality that may overcome cost and access barriers .
-OBJECTIVE	However , the ability of FOBT to reduce CRC mortality depends on high rates of adherence to annual screening .
-OBJECTIVE	To determine whether a multifaceted intervention increases adherence to annual FOBT compared with usual care .
-METHODS	Patient-level randomized controlled trial conducted in a network of community health centers .
-METHODS	Included were 450 patients who had previously completed a home FOBT from March 2011 through February 2012 and had a negative test result : 72 % of participants were women ; 87 % were Latino ; 83 % stated that Spanish was their preferred language ; and 77 % were uninsured .
-METHODS	Usual care at participating health centers included computerized reminders , standing orders for medical assistants to give patients home fecal immunochemical tests ( FIT ) , and clinician feedback on CRC screening rates .
-METHODS	The intervention group also received ( 1 ) a mailed reminder letter , a free FIT with low-literacy instructions , and a postage-paid return envelope ; ( 2 ) an automated telephone and text message reminding them that they were due for screening and that a FIT was being mailed to them ; ( 3 ) an automated telephone and text reminder 2 weeks later for those who did not return the FIT ; and ( 4 ) personal telephone outreach by a CRC screening navigator after 3 months .
-METHODS	Completion of FOBT within 6 months of the date the patient was due for annual screening .
-RESULTS	Intervention patients were much more likely than those in usual care to complete FOBT ( 82.2 % vs 37.3 % ; P < .001 ) .
-RESULTS	Of the 185 intervention patients completing screening , 10.2 % completed prior to their due date ( intervention was not given ) , 39.6 % within 2 weeks ( after initial intervention ) , 24.0 % within 2 to 13 weeks ( after automated call/text reminder ) , and 8.4 % between 13 and 26 weeks ( after personal call ) .
-CONCLUSIONS	This intervention greatly increased adherence to annual CRC screening ; most screenings were achieved without personal calls .
-CONCLUSIONS	It is possible to improve annual CRC screening for vulnerable populations with relatively low-cost strategies that are facilitated by health information technologies .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01453894 .
-
-###25173516
-OBJECTIVE	Lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) has been hypothesized to be involved in atherogenesis through pathways related to inflammation .
-OBJECTIVE	Darapladib is an oral , selective inhibitor of the Lp-PLA2 enzyme .
-OBJECTIVE	To evaluate the efficacy and safety of darapladib in patients after an acute coronary syndrome ( ACS ) event .
-METHODS	SOLID-TIMI 52 was a multinational , double-blind , placebo-controlled trial that randomized 13,026 participants within 30 days of hospitalization with an ACS ( non-ST-elevation or ST-elevation myocardial infarction [ MI ] ) at 868 sites in 36 countries .
-METHODS	Patients were randomized to either once-daily darapladib ( 160 mg ) or placebo on a background of guideline-recommended therapy .
-METHODS	Patients were followed up for a median of 2.5 years between December 7 , 2009 , and December 6 , 2013 .
-METHODS	The primary end point ( major coronary events ) was the composite of coronary heart disease ( CHD ) death , MI , or urgent coronary revascularization for myocardial ischemia .
-METHODS	Kaplan-Meier event rates are reported at 3 years .
-RESULTS	During a median duration of 2.5 years , the primary end point occurred in 903 patients in the darapladib group and 910 in the placebo group ( 16.3 % vs 15.6 % at 3 years ; hazard ratio [ HR ] , 1.00 [ 95 % CI , 0.91-1 .09 ] ; P = .93 ) .
-RESULTS	The composite of cardiovascular death , MI , or stroke occurred in 824 in the darapladib group and 838 in the placebo group ( 15.0 % vs 15.0 % at 3 years ; HR , 0.99 [ 95 % CI , 0.90-1 .09 ] ; P = .78 ) .
-RESULTS	There were no differences between the treatment groups for additional secondary end points , for individual components of the primary end point , or in all-cause mortality ( 371 events in the darapladib group and 395 in the placebo group [ 7.3 % vs 7.1 % at 3 years ; HR , 0.94 [ 95 % CI , 0.82-1 .08 ] ; P = .40 ) .
-RESULTS	Patients were more likely to report an odor-related concern in the darapladib group vs the placebo group ( 11.5 % vs 2.5 % ) and also more likely to report diarrhea ( 10.6 % vs 5.6 % ) .
-CONCLUSIONS	In patients who experienced an ACS event , direct inhibition of Lp-PLA2 with darapladib added to optimal medical therapy and initiated within 30 days of hospitalization did not reduce the risk of major coronary events .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01000727 .
-
-###24576866
-BACKGROUND	Disruptions in calcium ( Ca ) homeostasis during exercise may influence skeletal adaptations to exercise training .
-BACKGROUND	In young men , vigorous cycling causes increases in parathyroid hormone ( PTH ) and bone resorption ( C-terminal telopeptides of type I collagen [ CTX ] ) ; responses are attenuated by Ca supplementation .
-BACKGROUND	The study aimed to determine whether vigorous walking causes similar increases in PTH and CTX in older women and how the timing of Ca supplementation before and during exercise influences these responses .
-METHODS	In experiment 1 , 10 women ( 61 4 yr ) consumed 125 mL of either a Ca-fortified ( 1 gL ) or control beverage every 15 min during exercise starting 60 min before and continuing during 60 min of exercise .
-METHODS	In experiment 2 , 23 women ( 61 4 yr ) consumed 200 mL of a Ca-fortified ( 1 gL ) or control beverage every 15 min starting 15 min before and continuing during 60 min of exercise .
-METHODS	The exercise was treadmill walking at 75 % -80 % VO2peak .
-RESULTS	In experiment 1 , serum ionized Ca decreased in the control condition ( P < 0.001 ) , but not with Ca supplementation .
-RESULTS	PTH increased after exercise on both days ( Ca , P = 0.05 ; control , P = 0.009 ) but was attenuated by Ca supplementation ( 8.3 vs 26.1 pgmL ; P = 0.03 ) .
-RESULTS	CTX increased only on the control day ( P = 0.02 ) .
-RESULTS	In experiment 2 , serum ionized Ca decreased on Ca and control days ( Ca and control , P < 0.001 ) , but less so on the Ca day ( P = 0.04 ) .
-RESULTS	PTH ( Ca and control , P < 0.001 ) and CTX ( Ca , P = 0.02 ; control P = 0.007 ) increased on the Ca and control day , and there were no differences in the changes .
-CONCLUSIONS	The timing of Ca supplementation may be a key mediator of Ca homeostasis during acute exercise .
-CONCLUSIONS	Further research is necessary to determine how this influences skeletal adaptations to training .
-
-###24766637
-OBJECTIVE	To determine the extent to which children 's mastery motivation predicts occupational performance outcomes following upper limb intervention ( ULI ) .
-METHODS	In this cohort study , participants received 45 hours of ULI , either in an intensive group-based or distributed individualized model .
-METHODS	The Dimensions of Mastery Questionnaire ( DMQ ) measured mastery motivation at baseline .
-METHODS	Occupational performance outcomes were assessed at baseline and 13 weeks ' post-intervention using the Canadian Occupational Performance Measure ( COPM ) .
-METHODS	Multivariable models determined the contribution of mastery motivation to COPM outcome irrespective of group membership .
-RESULTS	Forty-two children with congenital hemiplegia ( 29 males , 13 females ; mean age 7y 8mo [ SD 2y 2mo ] ; range 5y 1mo-12y 8mo ; Manual Ability Classification System [ MACS ] I = 20 and II = 22 ; predominant motor type unilateral spastic n = 41 ) participated in the study .
-RESULTS	Significant gains were seen in COPM performance and satisfaction scores ( p < 0.001 ) post-intervention with no between group differences .
-RESULTS	Children who had greater persistence with object-oriented tasks ( p = 0.02 ) and better manual ability ( p = 0.03 ) achieved higher COPM performance scores at 13 weeks .
-RESULTS	Children 's persistence on object-oriented tasks was the strongest predictor of COPM satisfaction ( p = 0.01 ) .
-CONCLUSIONS	Children 's persistence with object-oriented tasks as well as manual abilities needs to be considered when undertaking ULI .
-CONCLUSIONS	Predetermining children 's motivational predispositions can assist clinicians to tailor therapy sessions individually based on children 's strengths , contributing to effective engagement in ULI .
-
-###25515217
-BACKGROUND	Cardiovascular disease ( CVD ) is the leading cause of death and disability worldwide .
-BACKGROUND	Despite the widespread availability of evidence-based clinical guidelines and validated risk predication equations for prevention and management of CVD , their translation into routine practice is limited .
-BACKGROUND	We developed a multifaceted quality improvement intervention for CVD risk management which incorporates electronic decision support , patient risk communication tools , computerised audit and feedback tools , and monthly , peer-ranked performance feedback via a web portal .
-BACKGROUND	The intervention was implemented in a cluster randomised controlled trial in 60 primary healthcare services in Australia .
-BACKGROUND	Overall , there were improvements in risk factor recording and in prescribing of recommended treatments among under-treated individuals , but it is unclear how this intervention was used in practice and what factors promoted or hindered its use .
-BACKGROUND	This information is necessary to optimise intervention impact and maximally implement it in a post-trial context .
-BACKGROUND	In this study protocol , we outline our methods to conduct a theory-based , process evaluation of the intervention .
-BACKGROUND	Our aims are to understand how , why , and for whom the intervention produced the observed outcomes and to develop effective strategies for translation and dissemination .
-METHODS	We will conduct four discrete but inter-related studies taking a mixed methods approach .
-METHODS	Our quantitative studies will examine ( 1 ) the longer term effectiveness of the intervention post-trial , ( 2 ) patient and health service level correlates with trial outcomes , and ( 3 ) the health economic impact of implementing the intervention at scale .
-METHODS	The qualitative studies will ( 1 ) identify healthcare provider perspectives on implementation barriers and enablers and ( 2 ) use video ethnography and patient semi-structured interviews to understand how cardiovascular risk is communicated in the doctor/patient interaction both with and without the use of intervention .
-METHODS	We will also assess the costs of implementing the intervention in Australian primary healthcare settings which will inform scale-up considerations .
-CONCLUSIONS	This mixed methods evaluation will provide a detailed understanding of the process of implementing a quality improvement intervention and identify the factors that might influence scalability and sustainability .
-BACKGROUND	12611000478910 .
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-###24774260
-OBJECTIVE	Intensive glucose control with insulin in patients with an acute coronary syndrome reduces platelet reactivity during hospitalization , compared to conventional control .
-OBJECTIVE	However , the effect of strict , long-term glucose control on platelet reactivity in these patients remains uncertain .
-METHODS	This is a prospective , randomized trial evaluating the effects of optimized glucose control ( target glucose , 80-120mg / dL ) with insulin , compared with conventional control ( target glucose , < 180 mg/dL ) , on platelet reactivity after hospital discharge in patients with an acute coronary syndrome and hyperglycemia .
-METHODS	The primary endpoint was assessment of platelet aggregation after stimulation with adenosine diphosphate 20 M at 12-month follow-up .
-RESULTS	One hundred four patients were randomized to optimized management ( n = 53 ) or conventional management ( n = 51 ) .
-RESULTS	There were no differences between groups in baseline characteristics or platelet function .
-RESULTS	After 12 months of follow-up , blood glucose levels were significantly lower in the optimized treatment group ( 104 vs 119mg/dL ; P < .001 ) .
-RESULTS	However , platelet aggregation following adenosine diphosphate 20 M stimulation showed no differences between the groups ( 54.2 % [ 14.3 % ] vs 55.1 % [ 18.3 % ] respectively ; P = .81 ) .
-RESULTS	There were no significant differences for other platelet function tests .
-CONCLUSIONS	Long-term optimized glucose control with insulin in patients with an acute coronary syndrome did not result in a reduction in platelet reactivity compared to conventional control .
-
-###24477825
-OBJECTIVE	To detect a difference in ( 1 ) intubation success and ( 2 ) successful intubation times between novice physicians using a Macintosh-style or video-assisted laryngoscope on a difficult airway manikin .
-METHODS	Prospective randomized trial .
-METHODS	Academic , tertiary medical center .
-METHODS	Forty first-year residents across a variety of disciplines with fewer than 5 total live intubations were recruited for the study .
-METHODS	Testing took place during orientation prior to commencement of clinical duties .
-METHODS	The entire group was provided training by faculty otolaryngologists and anesthesiologists using both laryngoscope types on a manikin airway simulator in a standard intubating scenario .
-METHODS	Subjects were then randomized into 2 testing groups , using either a Macintosh laryngoscope or video-assisted laryngoscope in a difficult intubation scenario .
-METHODS	The difficult airway simulation entailed oral cavity/oropharyngeal obstruction using inflation of the tongue , as well as cervical spine immobilization with a rigid collar preventing extension and elevation of the head and limiting oral cavity opening .
-METHODS	Success was defined as a confirmed endotracheal intubation by the testing instructor in 120 seconds or less .
-RESULTS	The Macintosh laryngoscope group ( n = 19 ) had an intubation success rate of 47.4 % with a mean intubation time of 69.0 seconds ( 95 % confidence interval [ CI ] : 52.7 , 85.2 ) .
-RESULTS	The video-assisted group ( n = 21 ) demonstrated a significantly higher success rate of 100 % ( P < .0001 ) and a decreased mean intubation time of 23.1 seconds ( 95 % CI : 18.4 , 27.8 ; P < .0001 ) .
-RESULTS	The mean difference in success rate between groups was 52.6 % ( 95 % CI : 30.0 % , 75.3 % ) .
-CONCLUSIONS	Novice physicians with little to no prior intubation experience showed significantly higher intubation success with lower intubation times using a video-assisted laryngoscope in a difficult airway manikin simulator .
-
-###25366684
-OBJECTIVE	To determine whether the addition of advanced-practice nurse ( APN ) telephone counseling to a printed survivorship care plan ( SCP ) significantly increases the proportion of at-risk survivors who complete cardiomyopathy screening .
-METHODS	Survivors age 25 years participating in the Childhood Cancer Survivor Study who received cardiotoxic therapy and reported no history of cardiomyopathy screening in the previous 5 years were eligible for enrollment .
-METHODS	The 472 participants ( mean age , 40.1 years ; range , 25.0 to 59.0 ; 53.3 % women ) were randomly assigned to either standard care , consisting of an SCP summarizing cancer treatment and cardiac health screening recommendations ( n = 234 ) , or standard care plus two APN telephone counseling sessions ( n = 238 ) .
-METHODS	The primary outcome-completion of cardiomyopathy screening within 1 year-was validated by medical records and compared between the two arms using adjusted relative risks ( RRs ) with 95 % CIs .
-RESULTS	Participants in the standard and APN counseling groups were not statistically different by demographic or clinical characteristics .
-RESULTS	At the time of 1-year follow-up , 107 ( 52.2 % ) of 205 survivors in the APN group completed screening compared with 46 ( 22.3 % ) of 206 survivors in the non-APN group ( P < .001 ) .
-RESULTS	With adjustment for sex , age ( < 30 v 30 years ) , and Children 's Oncology Group-recommended screening frequency group ( annual , 2 years , or 5 years ) , survivors in the APN group were > 2 more likely than those in the control group to complete the recommended cardiomyopathy screening ( RR , 2.31 ; 95 % CI , 1.74 to 3.07 ) .
-CONCLUSIONS	The addition of telephone counseling to an SCP with cardiac health screening recommendations increases cardiomyopathy screening in at-risk survivors .
-
-###24901761
-OBJECTIVE	The aim of this study was to evaluate the effect of dynamic bilateral postural stability on balance control and gait parameters in children with cerebral palsy .
-METHODS	Thirty children with spastic diplegia ( 8-10 yrs ) were included in this study .
-METHODS	The children were randomly assigned into two groups : control group A and study group B.
-METHODS	The children in both groups received traditional physical therapy program , 2 hrs per day for group A and 1.5 hrs followed by 30 mins of dynamic postural stability training program using the Biodex Stability System for group B.
-METHODS	The treatment frequency was three sessions per week for 8 consecutive weeks on two stability levels ( 7 and 8 ) .
-METHODS	The participating children received pretreatment and posttreatment assessments using the Biodex Stability System to evaluate the stability indices ( anteroposterior , mediolateral , and overall ) at the two stability levels ( 7 and 8 ) and three-dimensional motion analysis system ( pro-reflex system ) to evaluate the spatiotemporal parameters including step length , velocity , cycle time , stance , and swing phase percentage .
-RESULTS	The children in both groups showed significant improvements in the mean values of all measured variables after treatment indexed by a significant reduction in stability indices and improvement in gait parameters .
-RESULTS	The results also showed significant differences in all measured parameters in favor of group B , when compared with those in group A ( P < 0.01 ) .
-CONCLUSIONS	Balance training on the Biodex Stability System could be a useful tool in conjunction with traditional physical therapy program for improving balance control and gait functions in children with spastic diplegic cerebral palsy .
-
-###24433710
-OBJECTIVE	This study investigated coronary artery remodeling patterns associated with clinical outcomes .
-BACKGROUND	In the prospective , multicenter PROSPECT ( Providing Regional Observations to Study Predictors of Events in the Coronary Tree : An Imaging Study in Patients With Unstable Atherosclerotic Lesions ) study , reported predictors of nonculprit lesion ( NCL ) major adverse cardiac events ( MACE ) were an intravascular ultrasound ( IVUS ) minimal lumen area ( MLA ) 4 mm ( 2 ) , a plaque burden 70 % , and a IVUS-virtual histology ( VH ) thin-cap fibroatheroma ( TCFA ) , but not lesion site remodeling .
-METHODS	Overall , 697 consecutive patients with an acute coronary syndrome were enrolled and underwent 3-vessel gray-scale and IVUS-VH ; 3,223 NCLs were identified by IVUS .
-METHODS	The remodeling index ( RI ) was calculated as the external elastic membrane area at the MLA site divided by the average of the proximal and distal reference external elastic membrane areas .
-METHODS	First , one third of the patients were randomly selected to determine RI cutoffs related to NCL MACE ( development cohort ) .
-METHODS	Receiver-operating characteristic analysis showed that there were 2 separate cut points that predicted NCL MACE : RI = 0.8789 and RI = 1.0046 ( area under the curve = 0.663 ) .
-METHODS	These cut points were used to define negative remodeling as an RI < 0.88 , intermediate remodeling as an RI of 0.88 to 1.00 , and positive remodeling as an RI > 1.00 .
-METHODS	Second , we used the remaining two-thirds of patients to validate these cut points with respect to lesion morphology and clinical outcomes ( validation cohort ) .
-RESULTS	Kaplan-Meier curve analysis in the validation cohort showed that NCL MACE occurred more frequent ( and equally ) in negative and positive remodeling lesions compared with intermediate remodeling lesions .
-RESULTS	In this cohort , negative remodeling lesions had the smallest MLA , positive remodeling lesions had the largest plaque burden , and VH TCFA , especially VH TCFA with multiple necrotic cores , was most common in negatively remodeling lesions .
-CONCLUSIONS	The present study showed the novel concept that positive and negative lesion site remodeling was associated with unanticipated NCL MACE in the PROSPECT study .
-CONCLUSIONS	An Imaging Study in Patients With Unstable Atherosclerotic Lesions [ PROSPECT ] ; NCT00180466 ) .
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-###25527295
-BACKGROUND	Fixed-combination ocular hypotensives have multiple advantages , but triple-therapy dorzolamide/brimonidine/timolol ( dorz/brim/tim ) is only available in Latin and South America , and information on its relative efficacy is limited .
-BACKGROUND	This study compares the efficacy and tolerability of fixed-combination bimatoprost/timolol ( bim/tim ) and dorz/brim/tim in Mexican patients with primary open-angle glaucoma or ocular hypertension .
-METHODS	In this investigator-masked , crossover study , patients with unmet target intraocular pressure ( IOP ) on once-daily bim/tim or twice-daily dorz/brim/tim received the opposite medication for 3months before returning to their pre-baseline medication for 3months .
-METHODS	IOP was evaluated before and after morning instillation at months 2 , 3 , 5 and 6 .
-METHODS	Primary endpoints were mean IOP change and Ocular Surface Disease Index ( OSDI ) score at each visit .
-METHODS	The intent-to-treat population was the a priori analysis population , but due to the number of discontinuations , the per-protocol and intent-to-treat populations were used for the primary efficacy and sensitivity analyses , respectively .
-RESULTS	Seventy-eight and 56 patients were included in the intent-to-treat and per-protocol populations , respectively .
-RESULTS	At month 3 , statistically significant IOP reductions from baseline were observed in the bim/tim ( P < 0.01 ) and dorz/brim/tim ( P < 0.0001 ) groups , regardless of assessment time .
-RESULTS	At month 6 , patients returned to bim/tim exhibited no significant IOP increase ( regardless of assessment time ) , but patients returned to dorz/brim/tim exhibited a statistically significant IOP increase ( P < 0.001 ) when assessed before instillation of study treatment .
-RESULTS	Results were similar in both intent-to-treat and per-protocol analysis populations .
-RESULTS	In the per-protocol analysis , 70 % of patients on bim/tim at month 3 had an IOP < 14mm Hg , which declined to 58 % ( P = 0.0061 ) at month 6 ( ie , after 3months of dorz/brim/tim treatment ) .
-RESULTS	In patients receiving dorz/brim/tim at month 3 , 38 % had an IOP < 14mm Hg , which remained comparable after return to bim/tim .
-RESULTS	OSDI scores and incidence of adverse events were similar in both groups .
-CONCLUSIONS	In this first direct comparison of the efficacy of dorz/brim/tim and bim/tim , patients switched from dorz/brim/tim to bim/tim demonstrated improved/lower IOP ; when returned to dorz/brim/tim , IOP increased to levels seen at study initiation , suggesting that once-daily bim/tim may have greater IOP-lowering efficacy .
-CONCLUSIONS	Both bim/tim and dorz/brim/tim were well tolerated with minimal ocular surface damage .
-BACKGROUND	ClinicalTrials.gov : NCT01737853 ( registered October 9 , 2012 ) .
-
-###25175629
-OBJECTIVE	Wound complications negatively affect outcomes of lower extremity arterial reconstruction .
-OBJECTIVE	By way of an investigator initiated clinical trial , we tested the hypothesis that a silver-eluting alginate topical surgical dressing would lower wound complication rates in patients undergoing open arterial procedures in the lower extremity .
-METHODS	The study block-randomized 500 patients at three institutions to standard gauze or silver alginate dressings placed over incisions after leg arterial surgery .
-METHODS	This original operating room dressing remained until gross soiling , clinical need to remove , or postoperative day 3 , whichever was first .
-METHODS	Subsequent care was at the provider 's discretion .
-METHODS	The primary end point was 30-day wound complication incidence generally based on National Surgical Quality Improvement Program guidelines .
-METHODS	Demographic , clinical , quality of life , and economic end points were also collected .
-METHODS	Wound closure was at the surgeon 's discretion .
-RESULTS	Participants ( 72 % male ) were 84 % white , 45 % were diabetic , 41 % had critical limb ischemia , and 32 % had claudication ( with aneurysm , bypass revision , other ) .
-RESULTS	The overall 30-day wound complication incidence was 30 % , with superficial surgical site infection as the most common .
-RESULTS	In intent-to-treat analysis , silver alginate had no effect on wound complications .
-RESULTS	Multivariable analysis showed that Coumadin ( Bristol-Myers Squibb , Princeton , NJ ; odds ratio [ OR ] , 1.72 ; 95 % confidence interval [ CI ] , 1.03-2 .87 ; P = .03 ) , higher body mass index ( OR , 1.05 ; 95 % CI , 1.01-1 .09 ; P = .01 ) , and the use of no conduit/material ( OR , 0.12 ; 95 % CI , 0.82-3 .59 ; P < .001 ) were independently associated with wound complications .
-CONCLUSIONS	The incidence of wound complications remains high in contemporary open lower extremity arterial surgery .
-CONCLUSIONS	Under the study conditions , a silver-eluting alginate dressing showed no effect on the incidence of wound complications .
-
-###24752165
-BACKGROUND	Morbid obese ( MO ) population is increasing every year worldwide , and laparoscopic bariatric surgery ( LBS ) has a central role in their treatment .
-BACKGROUND	The postoperative period of MO is not free from complications .
-BACKGROUND	The introduction of sugammadex has brought huge developments in patient 's safety and nowadays LBS is performed with better care and quality .
-BACKGROUND	However , the effect of this agent in postoperative pain is still unknown .
-METHODS	A controlled trial enrolling 88 MO submitted to LBS under general anesthesia using muscle relaxation , randomly assigned into 2 groups : one received sugammadex ( SUG group ) at the end of surgery and the other neostigmine ( NEO group ) .
-METHODS	In the postanesthetic care unit ( PACU ) , we evaluated pain using the visual analogue scale in 4 different moments : arrival in the PACU , 30 minutes after arrival , 60 minutes after arrival , and immediately before leaving the PACU .
-METHODS	We also recorded the presence of postoperative nausea and vomits ( PONV ) and the duration of the PACU stay before discharge to the ward .
-RESULTS	Forty-four patients received sugammadex and 44 received neostigmine .
-RESULTS	We found lower visual analogue scale pain scores in the SUG group at 30 and 60 minutes after arriving to the PACU ( P < 0.05 ) .
-RESULTS	We also had less PONV in the SUG group and these patients were also discharged earlier .
-CONCLUSIONS	Sugammadex is associated with less pain felt in the PACU .
-CONCLUSIONS	This `` opioid-sparing '' effect , combined with less PONV and a faster discharge from the PACU , makes sugammadex an indispensable drug in this type of patients and allows fast-track surgery in the MO. .
-
-###24857600
-OBJECTIVE	To explore the relationship between goal setting and fruit and vegetable ( FV ) consumption and physical activity ( PA ) in an intervention for college students .
-METHODS	Secondary data analysis of intervention group participants from a 10-week online intervention with complete weekly data ( n = 724 ) .
-METHODS	Outcomes ( cups of FV per day and minutes of PA per week ) and goals for both behaviors were reported online each week .
-METHODS	Weekly differences between goals and behaviors were calculated , as well as the proportion meeting individual goals and meeting recommendations for behaviors .
-RESULTS	There were significant ( P < .05 ) effects of goal setting on both behaviors and of goal group ( tertile of meeting weekly goals ) on behavior , as well as meeting recommendations for both behaviors .
-RESULTS	There was an increase in FV consumption ( P < .001 ) but no change in PA over time .
-CONCLUSIONS	Goal setting as part of a Web-based intervention for college students was effective , but results differed for FV and PA. .
-CONCLUSIONS	Goal setting for maintaining behavior may need to differ from goal setting for changing behavior .
-
-###24683592
-OBJECTIVE	To evaluate the push-out bond strengths of prefabricated glass-fiber posts ( Beijing Oya Biomaterials ) with polydopamine functionalized to root dentin using two different resin cements ( Paracore and RelyX Unicem ) in different root regions ( cervical , middle , and apical ) .
-METHODS	Forty extracted human , single-rooted teeth were endodontically treated and a 9-mm post space was prepared in each tooth with post drills provided by the manufacturer .
-METHODS	Specimens were then randomly assigned into four groups ( n = 10 per group ) , depending on the adhesive system and post surface treatment used : group IA ( Paracore + polydopamine ) ; group IB ( Paracore + control ) ; group IIA ( RelyX Unicem + polydopamine ) ; group IIB ( RelyX Unicem + control ) .
-METHODS	Following post cementation , the specimens were stored in distilled water at 37C for 7 days .
-METHODS	The push-out test was performed using a universal testing machine ( 0.5 mm / min ) , and the failure modes were examined with a stereomicroscope .
-METHODS	Data were statistically analyzed using twoway ANOVA ( p = 0.05 ) .
-RESULTS	Bond strengths ( mean SD ) were : 7.909 3.166 MPa ( group IA ) , 4.675 2.170 MPa ( group IB ) , 8.186 2.766 MPa ( group IIA ) , 4.723 2.084 MPa ( group IIB ) .
-RESULTS	The bond strength of polydopamine groups was significantly higher than one of the control groups ( p < 0.0001 ) .
-RESULTS	No significant difference was found in the micro push-out bond strengths between the two resin cement groups or the root regions ( p > 0.05 ) .
-RESULTS	Stereomicroscopic analysis showed a higher percentage of adhesive than cohesive failures in all groups .
-CONCLUSIONS	Surface polydopamine functionalization was confirmed to be a reliable method for improving the bond strength of resin luting agents to fiber posts .
-CONCLUSIONS	The bond strength of Paracore to fiber posts was not significantly different from that of RelyX Unicem , and considering its convenient application , Paracore can be recommended .
-
-###24732940
-OBJECTIVE	To evaluate the comparative efficacy and safety of artemether-lumefantrine ( AL ) , artesunate-amodiaquine ( ASAQ ) and artesunate-amodiaquine-chlorpheniramine ( AQC ) for the treatment of acute uncomplicated malaria among Southwest Nigerian children .
-METHODS	One hundred and sixty children aged 6 months to 14 years with acute uncomplicated malaria were randomized to AL ( n = 53 ) , ASAQ ( n = 53 ) , or AQC ( n = 54 ) .
-METHODS	Enrollees were seen daily on days 0-3 and then on days 7 , 14 , 21 , 28 and 42 for clinical and parasitological evaluations .
-METHODS	Paired samples of genomic DNA at enrolment and at the time of recurrent parasitaemia were genotyped using nested PCR to distinguish between reinfection and recrudescence .
-METHODS	Detailed haematological and biochemical evaluations were carried out in a subset of enrollees on days 0 , 7 and 28 as part of a safety evaluation .
-RESULTS	Of the 160 children , 144 ( 90 % ) completed the study .
-RESULTS	The mean fever clearance times and parasite clearance times for AL , ASAQ and AQC were comparable ( p = 0.94 and p = 0.122 , respectively ) .
-RESULTS	On day 14 , the adequate clinical and parasitological response ( ACPR ) for AL and AQC was 100 % and for ASAQ it was 90 % ( p = 0.39 ) .
-RESULTS	The PCR-uncorrected results on days 28 and 42 and the ACPR-corrected results on day 42 were similar for all drugs ( p = 0.62 and p = 0.56 , respectively ) .
-RESULTS	AQC resulted in the best parasite clearance and haematological recovery on day 2 ( p = 0.022 and p = 0.018 , respectively ) .
-RESULTS	Biochemical parameters were not adversely affected by the three artemisinin-based combination therapies ( ACTs ) and these were well tolerated .
-CONCLUSIONS	The three ACTs were efficacious and safe , but AQC resulted in a better haematological recovery on day 2 and higher cure rates throughout the study period .
-
-###24253788
-METHODS	Prospective , randomized , controlled trial .
-OBJECTIVE	To compare arthrodesis rates between patients undergoing a primary single-level minimally invasive transforaminal lumbar interbody fusion ( MIS TLIF ) with either Actifuse or recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) .
-BACKGROUND	Preclinical animal studies suggest that silicate-substituted calcium phosphate ( Actifuse ) bone graft substitute offers equivalent or an increased fusion rate compared with other graft enhancers/extenders and rhBMP-2 .
-METHODS	Fifty-two patients undergoing a single-level unilateral MIS TLIF were evenly randomized into 2 cohorts as follows : the Actifuse cohort received Actifuse combined with 5 mL of bone marrow aspirate ( n = 26 ; 50 % ) , whereas the rhBMP cohort received 4.2 mg of rhBMP-2 ( n = 26 ; 50 % ) .
-METHODS	A pre hoc G * Power analysis yielded a sample size of n = 26 that was determined through a 2-tailed distribution calculation .
-METHODS	Computed tomographic analysis was performed at 6 months and 1 year postoperatively .
-METHODS	Pre - and postoperative visual analogue scale scores were obtained to assess the clinical outcomes .
-METHODS	Arthrodesis was determined by 2 separate , blinded orthopedic surgeons and a board certified radiologist .
-RESULTS	At 1-year follow-up , 65 % ( 17/26 ) of the Actifuse cohort and 92 % ( 24/26 ) of the rhBMP-2 cohort demonstrated a radiographical arthrodesis ( P = 0.01 ) .
-RESULTS	In both study cohorts , the 1-year postoperative visual analogue scale scores significantly improved ( P < 0.001 ) .
-RESULTS	Pseudarthrosis rates at 1 year were 35.0 % ( 9/26 ) and 7.7 % ( 2/26 ) for the Actifuse and rhBMP-2 groups , respectively ( P = 0.01 , OR = 6.35 , 95 % CI = 1.22-33 .1 ) .
-RESULTS	A greater reoperation rate was noted in the Actifuse cohort ( 35.0 % , 9/26 ) compared with the BMP-2 cohort ( 7.7 % , 2/26 ; P = 0.01 ) .
-RESULTS	One patient with BMP-2 also experienced symptomatic neuroforaminal bone growth ( 3.8 % , n = 1/26 ) .
-CONCLUSIONS	Silicate-substituted calcium phosphate was associated with a significantly lower rate of arthrodesis than rhBMP-2 in a MIS TLIF .
-CONCLUSIONS	The patients with pseudarthrosis in both cohorts were all clinically symptomatic with an unimproved visual analogue scale score .
-CONCLUSIONS	Additional analysis of Actifuse and other graft enhancers/extenders are needed prior to the utilization for an MIS TLIF .
-METHODS	2 .
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-###24656288
-BACKGROUND	Elevated serum uric acid is detected in pulmonary arterial hypertension ( PAH ) and is associated with poor patient outcomes .
-BACKGROUND	High serum uric acid is an independent risk factor for cardiovascular disease and renal impairment .
-BACKGROUND	We analyzed the effects of endothelin receptor antagonism on serum uric acid in PAH patients participating in the Sitaxentan to Relieve Impaired Exercise ( STRIDE ) -2 / 2X trial , and the impact of uric acid on 6-minute walk distance ( 6MWD ) , time to clinical worsening ( TtCW ) and survival .
-METHODS	In the 18-week , double-blind , placebo-controlled STRIDE-2 trial , 246 PAH patients were randomized and received matched placebo , sitaxentan 50 or 100 mg orally once daily , or open-label bosentan 125 mg twice daily .
-METHODS	STRIDE-2X was a 1-year , open-label extension of STRIDE-2 .
-RESULTS	Baseline serum uric acid was similar between groups .
-RESULTS	Increased serum uric acid was a significant risk factor for 1-year mortality and TtCW .
-RESULTS	Compared with placebo , sitaxentan 50 and 100 mg and bosentan all reduced serum uric acid ( p < 0.05 ) .
-RESULTS	Reduced serum uric acid correlated with increased 6MWD ( p = 0.0037 ) .
-CONCLUSIONS	Endothelin receptor antagonism reduces serum uric acid in PAH patients , and this reduction is associated with improved survival and longer TtCW .
-CONCLUSIONS	Further prospective studies are needed to investigate the pathogenic role of serum uric acid in PAH and its prognostic potential .
-
-###25056277
-BACKGROUND	Extending the time a parturient is left sitting after induction of spinal anesthesia ( i.e. , the seated time ) has had varying success in decreasing hypotension at Cesarean delivery .
-BACKGROUND	This may be due to the current lack of information concerning the dose-response relationship of seated time and rates of hypotension .
-METHODS	Term parturients scheduled for Cesarean delivery were randomized to receive 11.25 or 15.0 mg of 0.75 % intrathecal hyperbaric bupivacaine , and they remained seated after injection for a length of time determined by an up-down sequential method .
-METHODS	They were then placed in a wedged position and their blood pressure was measured every minute .
-METHODS	Pre-delivery hypotension was considered present if there was a > 20 % from baseline drop in systolic blood pressure .
-METHODS	The seated time at which 50 % of parturients avoided pre-delivery hypotension ( median effective seated time ) was determined with isotonic regression .
-RESULTS	Fifty patients were studied .
-RESULTS	For the 11.25-mg and 15.0-mg groups , the median effective seated time ( 95 % confidence interval [ CI ] ) was 130 sec ( 95 % CI 117 to 150 ) and 385 sec ( 95 % CI 381 to 396 ) , respectively .
-CONCLUSIONS	There exists a seated time after intrathecal injection of hyperbaric bupivacaine where 50 % of parturients do not experience hypotension .
-CONCLUSIONS	This seated time increases with an increased dose of bupivacaine .
-CONCLUSIONS	Further work is required to determine the full relationship between seated time and hypotension for other doses of anesthetic and to investigate the clinical utility of this technique for prevention of hypotension .
-CONCLUSIONS	This trial was registered at www.clinicaltrials.gov ( NCT01561274 ) .
-
-###25445313
-BACKGROUND	Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation .
-BACKGROUND	This paper presents the rationale , design , and study protocol for a randomized controlled trial , the aim of which is to evaluate the efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for reinforcement of a midline fascial closure .
-METHODS	The PREBIOUS trial ( PREventive midline laparotomy closure with a BIOabsorbable mesh ) is a multicenter randomized controlled trial in which adult patients undergoing elective or urgent open abdominal operations through a midline laparotomy incision are assigned to one of two groups based on the laparotomy closure procedure : an intervention group in which a continuous polydioxanone ( PDS ) suture is reinforced with a commercially available GORE BIO-A Tissue Reinforcement prosthesis ( W.L. Gore & Associates , Flagstaff , AZ , USA ) , or a control group with continuous PDS suture only .
-METHODS	Both groups are followed over 6 months .
-RESULTS	The primary outcome is the appearance of incisional hernias assessed by physical examination at clinical visits and radiologically ( CT scan ) performed at the end of follow-up .
-RESULTS	Secondary outcomes are the rate of complications , mainly infection , hematoma , burst abdomen , pain , and reoperation .
-RESULTS	The PREBIOUS trial has the potential to demonstrate that suture plus prosthetic mesh insertion for routine midline laparotomy closure is effective in preventing incisional hernias after open abdominal surgery , to avoid the effects on those affected , such as poor cosmesis , social embarrassment , or impaired quality of life , and to save costs potentially associated with incisional hernia surgical repair .
-
-###25247517
-OBJECTIVE	Prenatal genetic testing guidelines recommend providing patients with detailed information to allow informed , preference-based screening and diagnostic testing decisions .
-OBJECTIVE	The effect of implementing these guidelines is not well understood .
-OBJECTIVE	To analyze the effect of a decision-support guide and elimination of financial barriers to testing on use of prenatal genetic testing and decision making among pregnant women of varying literacy and numeracy levels .
-METHODS	Randomized trial conducted from 2010-2013 at prenatal clinics at 3 county hospitals , 1 community clinic , 1 academic center , and 3 medical centers of an integrated health care delivery system in the San Francisco Bay area .
-METHODS	Participants were English - or Spanish-speaking women who had not yet undergone screening or diagnostic testing and remained pregnant at 11 weeks ' gestation ( n = 710 ) .
-METHODS	A computerized , interactive decision-support guide and access to prenatal testing with no out-of-pocket expense ( n = 357 ) or usual care as per current guidelines ( n = 353 ) .
-METHODS	The primary outcome was invasive diagnostic test use , obtained via medical record review .
-METHODS	Secondary outcomes included testing strategy undergone , and knowledge about testing , risk comprehension , and decisional conflict and regret at 24 to 36 weeks ' gestation .
-RESULTS	Women randomized to the intervention group , compared with those randomized to the control group , were less likely to have invasive diagnostic testing ( 5.9 % vs 12.3 % ; odds ratio [ OR ] , 0.45 [ 95 % CI , 0.25-0 .80 ] ) and more likely to forgo testing altogether ( 25.6 % vs 20.4 % ; OR , 3.30 [ 95 % CI , 1.43-7 .64 ] , reference group screening followed by invasive testing ) .
-RESULTS	Women randomized to the intervention group also had higher knowledge scores ( 9.4 vs 8.6 on a 15-point scale ; mean group difference , 0.82 [ 95 % CI , 0.34-1 .31 ] ) and were more likely to correctly estimate the amniocentesis-related miscarriage risk ( 73.8 % vs 59.0 % ; OR , 1.95 [ 95 % CI , 1.39-2 .75 ] ) and their estimated age-adjusted chance of carrying a fetus with trisomy 21 ( 58.7 % vs 46.1 % ; OR , 1.66 [ 95 % CI , 1.22-2 .28 ] ) .
-RESULTS	Significant differences did not emerge in decisional conflict or regret .
-CONCLUSIONS	Full implementation of prenatal testing guidelines using a computerized , interactive decision-support guide in the absence of financial barriers to testing resulted in less test use and more informed choices .
-CONCLUSIONS	If validated in additional populations , this approach may result in more informed and preference-based prenatal testing decision making and fewer women undergoing testing .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00505596 .
-
-###24290909
-OBJECTIVE	Undernutrition in older age is associated with adverse clinical outcomes and high health care costs .
-OBJECTIVE	This study aimed to evaluate the cost-effectiveness of a dietetic treatment in primary care compared with usual care in older , undernourished , community-dwelling individuals .
-METHODS	A parallel randomized controlled trial .
-METHODS	Primary care .
-METHODS	A total of 146 undernourished , independently living older ( 65 years ) individuals .
-METHODS	Dietetic treatment .
-METHODS	Main outcomes were change in kilogram body weight compared with baseline and quality-adjusted life years ( QALYs ) after 6 months .
-METHODS	Costs were measured from a societal perspective .
-METHODS	The main analysis was performed according to the intention-to-treat principle .
-METHODS	Multiple imputation was used to impute missing data and bootstrapping was used to estimate uncertainty surrounding cost differences and incremental cost-effectiveness ratios .
-METHODS	Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated .
-RESULTS	The participants were randomized to receive either dietetic treatment ( n = 72 ) or usual care ( n = 74 ) .
-RESULTS	After 6 months , no statistically significant differences were found between the dietetic treatment and usual care group in body weight change ( mean difference 0.78 kg , 95 % CI -0.26 -1.82 ) , QALYs ( mean difference 0.001 , 95 % CI -0.04 -0.04 ) and total costs ( mean difference 1645 , 95 % CI -525 -3547 ) .
-RESULTS	The incremental cost-utility ratio ( ICUR ) for QALYs was not interpretable .
-RESULTS	The incremental cost-effectiveness ratio ( ICER ) for body weight gain was 2111 .
-RESULTS	The probability that dietetic treatment is cost-effective compared with usual care was 0.78 for a ceiling ratio of 5000 for body weight and 0.06 for a ceiling ratio of 20.000 for QALY .
-CONCLUSIONS	In this study , dietetic treatment in older , undernourished , community-dwelling individuals was not cost-effective compared with usual care .
-
-###25208569
-BACKGROUND	Despite great need , the number of HIV prevention implementation studies remains limited .
-BACKGROUND	The challenge for researchers , in this time of limited HIV services agency resources , is to conceptualize and test how to disseminate efficacious , practical , and sustainable prevention programs more rapidly , and to understand how to do so in the absence of additional agency resources .
-BACKGROUND	We tested whether training and technical assistance ( TA ) in a couple-based HIV prevention program using a Web-based modality would yield greater program adoption of the program compared to training and TA in the same program in a manual-based modality among facilitators who delivered the interventions at 80 agencies in New York State .
-METHODS	This study used a cluster randomized controlled design .
-METHODS	Participants were HIV services agencies ( N = 80 ) and up to 6 staff members at each agency ( N = 253 ) .
-METHODS	Agencies were recruited , matched on key variables , and randomly assigned to two conditions .
-METHODS	Staff members participated in a four-day , face-to-face training session , followed by TA calls at two and four months , and follow-up assessments at 6 , 12 , and 18 months post - training and TA .
-METHODS	The primary outcomes examined number of couples with whom staff implemented the program , mean number of sessions implemented , whether staff implemented at least one session or whether staff implemented a complete intervention ( all six sessions ) of the program .
-METHODS	Outcomes were measured at both the agency and participant level .
-RESULTS	Over 18 months following training and TA , at least one participant from 13 ( 33 % ) Web-based assigned agencies and 19 ( 48 % ) traditional agencies reported program use .
-RESULTS	Longitudinal multilevel analysis found no differences between groups on any outcomes at the agency or participant level with one exception : Web-based agencies implemented the program with 35 % fewer couples compared with staff at manual-based agencies ( IRR 0.35 , CI , 0.13-0 .94 ) .
-CONCLUSIONS	Greater implementation of a Web-based program may require more resources and staff exposure , especially when paired with a couple-based modality .
-CONCLUSIONS	Manual-based and traditional programs may hold some advantage or ease for implementation , particularly at a time of low economic resources .
-BACKGROUND	ClinicalTrials.gov identifier : NCT01863537 .
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-###24351495
-BACKGROUND	Chronic kidney disease ( CKD ) is highly prevalent in patients with diabetes or hypertension in primary care .
-BACKGROUND	A shared care model could improve quality of care in these patients
-OBJECTIVE	To assess the effect of a shared care model in managing patients with CKD who also have diabetes or hypertension .
-OBJECTIVE	Design and setting A cluster randomised controlled trial in nine general practices in The Netherlands .
-METHODS	Five practices were allocated to the shared care model and four practices to usual care for 1 year .
-METHODS	Primary outcome was the achievement of blood pressure targets ( 130/80 mmHg ) and lowering of blood pressure in patients with diabetes mellitus or hypertension and an estimated glomerular filtration rate ( eGFR ) < 60 ml/min/1 .73 m ( 2 ) .
-RESULTS	Data of 90 intervention and 74 control patients could be analysed .
-RESULTS	Blood pressure in the intervention group decreased with 8.1 ( 95 % CI = 4.8 to 11.3 ) / 1.1 ( 95 % CI = -1.0 to 3.2 ) compared to -0.2 ( 95 % CI = -3.8 to 3.3 ) / -0.5 ( 95 % CI = -2.9 to 1.8 ) in the control group .
-RESULTS	Use of lipid-lowering drugs , angiotensin-system inhibitors and vitamin D was higher in the intervention group than in the control group ( 73 % versus 51 % , 81 % versus 64 % , and 15 % versus 1 % , respectively , [ P = 0.004 , P = 0.01 , and P = 0.002 ] ) .
-CONCLUSIONS	A shared care model between GP , nurse practitioner and nephrologist is beneficial in reducing systolic blood pressure in patients with CKD in primary care .
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-###24787312
-BACKGROUND	The treatment of clubfoot by the Ponseti method requires the utilization of a foot abduction orthosis ( FAO ) after manipulation and casting .
-BACKGROUND	Adherence to this protocol , specifically FAO wear rates , has been postulated to improve treatment outcomes .
-BACKGROUND	Our hypothesis was that caregiver-reported wear rates were significantly less than actual wear rates in these braces .
-METHODS	A randomized prospective study of 67 children , aged 0 to 3 years old with idiopathic clubfoot , treated using the Ponseti technique for idiopathic clubfoot , was undertaken after IRB approval .
-METHODS	Participants were randomized into 3 groups : a functioning pressure-based sensor ( group FPS ) attached to the FAO ( 21 patients ) , a nonfunctioning sensor ( NFPS group ) attached to the FAO ( 24 patients ) , or no sensor ( NS group ) ( 22 patients ) .
-METHODS	All caregivers filled out a diary of subjective wear rates .
-METHODS	Reported and actual wear rates were recorded as a percentage of the entire day and compared .
-RESULTS	In the FPS group , the average actual wear rate for months 1 , 2 , and 3 were 91.7 % ( 15 patients ; 72.7 % to 97.0 % ) , 86.8 % ( 9 patients ; 60.5 % to 96.3 % ) , and 77.1 % ( 7 patients ; 52.6 % to 95.8 % ) , respectively .
-RESULTS	The average self-reported wear rate in the FPS group in months 1 , 2 , and 3 were 94.9 % ( 13 patients ; 93.1 % to 98.7 % ) , 95.6 % ( 10 patients ; 92.3 % to 99.4 % ) , and 94.8 % ( 11 patients ; 82.8 % to 99.6 % ) , respectively .
-RESULTS	The most predictive factor in determining a patient 's decrease in the overall wear rate was a drop in the wear rate between months 1 and 2 ( P < 0.001 ) .
-RESULTS	The reported wear rates were not statistically different between any of the 3 groups ( P < 0.01 ) .
-CONCLUSIONS	By using a novel method of pressure measurement , which documented FAO wear , we have shown a significant decline in wear rates from months 1 to 3 .
-CONCLUSIONS	These actual FAO wear rates did not match their reported rates , thus putting into question previous assumptions about reported brace compliance .
-CONCLUSIONS	The largest drop in wear rates occurred from months 2 to 3 .
-CONCLUSIONS	This study provides the first objective measurement of FAO brace wear in patients undergoing the Ponseti method of treatment .
-METHODS	Level II .
-
-###24328847
-OBJECTIVE	The purpose of this study was to compare secondary intention healing of oral soft tissues after laser surgery with and without the use of a compound containing amino acids and sodium hyaluronate .
-BACKGROUND	Sodium hyaluronate has been successfully used in medicine to promote healing .
-BACKGROUND	It has not been studied in the healing of laser-produced wounds .
-METHODS	Excisional biopsy was performed in oral soft tissues with a potassium-titanyl-phosphate ( KTP ) laser ( 532 nm , SmartLite , DEKA , Florence , Italy ) in 49 patients divided into two groups .
-METHODS	In the study group ( SG ) , 31 patients received a compound gel containing four amino acids and sodium hyaluronate ( Aminogam ( ) , Errekappa , Italy ) after laser surgery ; in the control group ( CG ) , 18 subjects received no treatment involving a drug or gel .
-METHODS	Numeric rating scale ( NRS ) was used to evaluate pain experienced after surgery [ pain index ( PI ) ] .
-METHODS	Using a grid as a benchmark and computer software , the lesion area was measured after surgery ( T0 ) and after 7 days ( T1 ) .
-METHODS	A percentage healing index ( PHI ) was calculated indicating healing extension in 7 days .
-RESULTS	SG cases showed an average PHI of 64.3826.50 , whereas the average PHI in the CG was 47.88 % 27.84 .
-RESULTS	Mean PI was 2.670.96 for SG and 2.750.86 for CG .
-RESULTS	A statistically significant difference was detected between the groups for PHI ( p = 0.0447 ) , whereas no difference was detectable for PI ( p = 0.77 ) .
-CONCLUSIONS	The use of a gel containing amino acids and sodium hyaluronate can promote faster healing via secondary intention in laser-induced wounds , although it does not seem to affect pain perception .
-
-###24557812
-BACKGROUND	To facilitate the transfer of exercise effects to older adults ' everyday life , essential daily life movements ( stair climbing and walking on different surfaces ) were embedded into the functional movement circle for older adults ( FuMoC ) -- a systematic balance and resistance training programme supplemented by functional movements .
-OBJECTIVE	This study 's aim was to consider the feasibility of the FuMoC and to evaluate the effects of this new training programme in a randomised controlled pilot study .
-METHODS	Twenty-one adults aged 60years and older were randomised into one of two groups .
-METHODS	The intervention group ( IG ; n = 11 ) trained for 12weeks in the FuMoC , while the control group ( CG ; n = 10 ) maintained their usual activities .
-METHODS	The evaluation of feasibility comprised training attendance , realised intensity of load , and perceived exertion .
-METHODS	Outcome variables included measures of strength and performance-based tests of mobility-related activities .
-RESULTS	Training attendance was 86 % and the prescribed intensity of load was realised by the participants in the IG .
-RESULTS	Physical performance showed significant improvements in the IG in comparison to the CG : an increase of 24 % in the One-Repetition Maximum test in the chest press ( p < 0.05 ) , of 9-13 % in the modified Timed Up and Go test ( p < 0.05 ) , and of 10 % in the Maximal Step Length test ( p < 0.05 ) was identified .
-CONCLUSIONS	In conclusion , the FuMoC study was feasible in terms of compliance ( training attendance ) and the planned exercise regimen ( suitable exercises , intensity , and exertion ) and showed positive effects on physical performance .
-
-###24767638
-OBJECTIVE	Patient-controlled epidural analgesia ( PCEA ) and continuous epidural infusion ( CEI ) are popular and effective methods for pain relief during labor ; however , there are concerns about increasing rates of cesarean section ( C/S ) and instrumental delivery .
-OBJECTIVE	This prospective study investigated the effect of PCEA and CEI with different formulas on labor and the mode of delivery in nulliparous women .
-METHODS	A total of 480 nulliparous women were randomized into four groups , with 120 in each .
-METHODS	Group A received a loading dose of 10mL of 1mg/mL ropivacaine with 2g/mL fentanyl , then an intermittent bolus of 5mL with a background infusion of 5mL/hour by PCEA .
-METHODS	Group B received the same PCEA formula as Group A with 0.8 mg/mL bupivacaine .
-METHODS	Group C received the same formula as Group A by CEI with 1mg/mL ropivacaine at a rate of 10mL/hour .
-METHODS	Group D received the same formula as Group C with 0.8 mg/mL bupivacaine .
-METHODS	The rates of C/S and instrumental delivery and the incidence of side effects were recorded .
-RESULTS	The rates of C/S were significantly different between Groups A and C , Groups A and D , and Groups B and D.
-RESULTS	The rates of instrumental delivery for normal spontaneous delivery were significantly different between Groups A and B , A and D , B and C , and C and D.
-CONCLUSIONS	The C/S rate was higher in Groups C and D ; however , the instrumental delivery rate was lower in Groups A and C.
-CONCLUSIONS	We conclude that PCEA with 1mg/mL ropivacaine might provide the greatest benefit for labor analgesia .
-
-###26305528
-OBJECTIVE	The purpose of this study was to assess the inflammatory status of the aqueous humor in the fellow eye after uneventful cataract surgery in the first eye .
-METHODS	At the screening stage , aqueous humor samples from 15 first-eye and 15 second-eye cataract patients were collected just before cataract surgery and assayed using human cytokine antibody array .
-METHODS	Screened cytokines were then verified using a suspension array system with aqueous humor samples obtained from 35 first-eye and 36 second-eye cataract patients .
-RESULTS	The cytokine antibody array revealed that interleukin-1 receptor antagonist ( Il-1ra ) and macrophage inflammatory protein ( MIP ) -1 a and MIP-1b were expressed at high levels in first-eye patients and were lower in second-eye patients , whereas opposite trends were found for monocyte chemoattractant protein 1 ( MCP-1 ) and for regulated on activation , normal T expressed and secreted ( RANTES ) ( all , P < 0.05 , Student 's t-test ) .
-RESULTS	However , only MCP-1 and IL-1ra were significantly different between the two groups after Bonferroni correction ( both P < 0.00125 ) .
-RESULTS	In the replication stage , the suspension cytokine array revealed that only MCP-1 expression was significantly greater in the aqueous humor of second-eye patients than in that of first-eye patients ( P = 0.0067 , Student 's t-test ) .
-CONCLUSIONS	This study revealed that expression of MCP-1 , a pain-related inflammatory chemokine , was significantly increased in aqueous humor in the contralateral eye after first-eye cataract surgery .
-CONCLUSIONS	This suggests there may be a sympathetic ophthalmic type uveitis in the contralateral eye after first-eye cataract surgery and that may help to explain why second-eye phacoemulsification is often more painful .
-CONCLUSIONS	( ClinicalTrials.gov number , NCT01824927 . )
-
-###24452238
-BACKGROUND	Observed associations between increased fruit and vegetable ( F&V ) consumption , particularly those F&V s that are rich in flavonoids , and vascular health improvements require confirmation in adequately powered randomized controlled trials .
-OBJECTIVE	This study was designed to measure the dose-response relation between high-flavonoid ( HF ) , low-flavonoid ( LF ) , and habitual F&V intakes and vascular function and other cardiovascular disease ( CVD ) risk indicators .
-METHODS	A single-blind , dose-dependent , parallel randomized controlled dietary intervention study was conducted .
-METHODS	Male and female low-F & V consumers who had a 1.5-fold increased risk of CVD ( n = 174 ) were randomly assigned to receive an HF F&V , an LF F&V , or a habitual diet , with HF and LF F&V amounts sequentially increasing by 2 , 4 , and 6 ( +2 , +4 , and +6 ) portions/d every 6 wk over habitual intakes .
-METHODS	Microvascular reactivity ( laser Doppler imaging with iontophoresis ) , arterial stiffness [ pulse wave velocity , pulse wave analysis ( PWA ) ] , 24-h ambulatory blood pressure , and biomarkers of nitric oxide ( NO ) , vascular function , and inflammation were determined at baseline and at 6 , 12 , and 18 wk .
-RESULTS	In men , the HF F&V diet increased endothelium-dependent microvascular reactivity ( P = 0.017 ) with +2 portions/d ( at 6 wk ) and reduced C-reactive protein ( P = 0.001 ) , E-selectin ( P = 0.0005 ) , and vascular cell adhesion molecule ( P = 0.0468 ) with +4 portions/d ( at 12 wk ) .
-RESULTS	HF F&V s increased plasma NO ( P = 0.0243 ) with +4 portions/d ( at 12 wk ) in the group as a whole .
-RESULTS	An increase in F&V s , regardless of flavonoid content in the groups as a whole , mitigated increases in vascular stiffness measured by PWA ( P = 0.0065 ) and reductions in NO ( P = 0.0299 ) in the control group .
-CONCLUSIONS	These data support recommendations to increase F&V intake to 6 portions daily , with additional benefit from F&V s that are rich in flavonoids , particularly in men with an increased risk of CVD .
-
-###25151552
-BACKGROUND	We examined the effectiveness of traditional technical training ( TT ) and quiet eye training ( QET ) on the performance of 1-handed square knot tying among first-year surgery residents under normal and high-anxiety conditions .
-METHODS	Twenty surgery residents were assigned randomly to 1 of 2 groups and completed pretest , training , and simple and complex retention tests under conditions of high and low anxiety .
-METHODS	The TT group received traditional instruction on improving hand movements ; the QET group received feedback on their gaze behaviors .
-METHODS	Participants wore an eye tracker that recorded simultaneously their gaze and hand movements .
-METHODS	Dependent variables were knot tying performance ( % ) , quiet eye duration ( % ) , number of fixations , and total movement time ( s ) .
-RESULTS	Both groups improved their knot tying performance ( P < .05 ) from pretest to the low anxiety conditions ( mean difference : QET , 28 % ; TT , 17 % ) ; however , only the QET group maintained their knot tying performance under the high-anxiety conditions ( mean difference : QET , 18 % ; P < .05 ) , with the TT group decreasing their performance close to pretest levels ( P > .05 ) .
-RESULTS	The QET group also demonstrated more efficient gaze and hand movements post training .
-CONCLUSIONS	These data demonstrate the effectiveness of training gaze behaviors , not only to improve the effectiveness and efficiency of performance , but also to mediate negative effects of anxiety on performance .
-CONCLUSIONS	These findings may have important implications for medical educators and practitioners , as well as surgeons who may be ( re ) training or learning new procedures .
-
-###24823727
-OBJECTIVE	Chronic subdural hematoma ( CSDH ) recurs after surgical evacuation in 5-30 % of patients .
-OBJECTIVE	Inserting subdural drain might reduce the recurrence rate , but is not commonly practiced .
-OBJECTIVE	There are few prospective studies to evaluate the effect of subdural drains .
-METHODS	A prospective randomized study to investigate the effect of subdural drains in the on recurrence rates and clinical outcome following burr-hole drainage ( BHD ) of CSDH was undertaken .
-METHODS	During the study period , 246 patients with CSDH were assessed for eligibility .
-METHODS	Among 200 patients fulfilling the eligibility criteria , 100 each were assigned to `` drain group '' ( drain inserted into the subdural space following BHD ) and `` without drain group '' ( subdural drain was not inserted following BHD ) using random allocation software .
-METHODS	The primary end point was recurrence needing re-drainage up to a period of 6 months from surgery .
-RESULTS	Recurrence occurred in 9 of 100 patients with a drain , and 26 of 100 patients in without drain group ( P = 0.002 ) .
-RESULTS	The mortality was 5 % in patients with drain and 4 % in patients without drain group ( P = 0.744 ) .
-RESULTS	The medical and surgical complications were comparable between the two study groups .
-CONCLUSIONS	Use of a subdural drain after burr-hole evacuation of a CSDH reduces the recurrence rate and is not associated with increased complications .
-
-###24825486
-OBJECTIVE	No effective pharmacotherapy for methamphetamine ( MA ) use disorder has yet been found .
-OBJECTIVE	This study evaluated sustained-release methylphenidate ( MPH-SR ) compared with placebo ( PLA ) for treatment of MA use disorder in people also undergoing behavioral support and motivational incentives .
-METHODS	This was a randomized , double-blind , placebo-controlled design with MPH-SR or PLA provided for 10 weeks ( active phase ) followed by 4 weeks of single-blind PLA .
-METHODS	Twice-weekly clinic visits , weekly group counseling ( CBT ) and motivational incentives ( MI ) for MA-negative urine drug screens ( UDS ) were included .
-METHODS	Treatment sites were in Los Angeles , California ( LA ) and Honolulu , Hawaii ( HH ) , USA .
-METHODS	A total of 110 MA-dependent ( via DSM-IV ) participants ( LA = 90 ; HH = 20 ) .
-METHODS	The primary outcome measure is self-reported days of MA use during the last 30 days of the active phase .
-METHODS	Included in the current analyses are drug use ( UDS and self-report ) , retention , craving , compliance ( dosing , CBT , MI ) , adverse events and treatment satisfaction .
-RESULTS	No difference was found between treatment groups in self-reported days of MA use during the last 30 days of the active phase ( P = 0.22 ) .
-RESULTS	In planned secondary outcomes analyses , however , the MPH group had fewer self-reported MA use days from baseline through the active phase compared with the PLA group ( P = 0.05 ) .
-RESULTS	The MPH group also had lower craving scores and fewer marijuana-positive UDS than the PLA group in the last 30 days of the active phase .
-RESULTS	The two groups had similar retention , other drug use , adverse events and treatment satisfaction .
-CONCLUSIONS	Methylphenidate may lead to a reduction in concurrent methamphetamine use when provided as treatment for patients undergoing behavioral support for moderate to severe methamphetamine use disorder , but this requires confirmation .
-
-###24706097
-BACKGROUND	Depression and adherence to antidepressant treatment are important clinical concerns in diabetes care .
-BACKGROUND	While patient-provider communication patterns have been associated with adherence for cardiometabolic medications , it is unknown whether interpersonal aspects of care impact antidepressant medication adherence .
-OBJECTIVE	To determine whether shared decision-making , patient-provider trust , or communication are associated with early stage and ongoing antidepressant adherence .
-METHODS	Observational new prescription cohort study .
-METHODS	Kaiser Permanente Northern California .
-METHODS	One thousand five hundred twenty-three adults with type 2 diabetes who completed a survey in 2006 and received a new antidepressant prescription during 2006-2010 .
-METHODS	Exposures included items based on the Trust in Physicians and Interpersonal Processes of Care instruments and the Consumer Assessment of Healthcare Providers and Systems ( CAHPS ) communication scale .
-METHODS	Measures of adherence were estimated using validated methods with physician prescribing and pharmacy dispensing data : primary non-adherence ( medication never dispensed ) , early non-persistence ( dispensed once , never refilled ) , and new prescription medication gap ( NPMG ; proportion of time without medication during 12 months after initial prescription ) .
-RESULTS	After adjusting for potential confounders , patients ' perceived lack of shared decision-making was significantly associated with primary non-adherence ( RR = 2.42 , p < 0.05 ) , early non-persistence ( RR = 1.34 , p < 0.01 ) and NPMG ( estimated 5 % greater gap in medication supply , p < 0.01 ) .
-RESULTS	Less trust in provider was significantly associated with early non-persistence ( RRs 1.22-1 .25 , ps < 0.05 ) and NPMG ( estimated NPMG differences 5-8 % , ps < 0.01 ) .
-CONCLUSIONS	All patients were insured and had consistent access to and quality of care .
-CONCLUSIONS	Patients ' perceptions of their relationships with providers , including lack of shared decision-making or trust , demonstrated strong associations with antidepressant non-adherence .
-CONCLUSIONS	Further research should explore whether interventions for healthcare providers and systems that foster shared decision-making and trust might also improve medication adherence .
-
-###25686324
-OBJECTIVE	To evaluate the feasibility of full-mouth debridement ( subgingival scaling and root planning , SRP ) by 2 times within 1 week and compare the clinical effects of different sequences of debridement-antibiotic usage in patients with severe chronic periodontitis ( CP ) .
-METHODS	A double-blinded , placebo-controlled , randomized clinical trial was conducted in 30 severe CP patients ( 14 males and 16 females , 40.5 8.4 years old on average from 35 to 60 ) receiving 3 different sequences of debridement-antibiotictherapy : Group A , antibiotic usage ( metronidazole , MTZ , 0.2 g , tid , 7 d ; amoxicillin , AMX 0.5 g , tid , 7 d ) was started together with SRP ( completed by 2 times in 7 d ) ; Group B , antibiotic usage ( MTZ 0.2 g , tid , 7 d ; AMX 0.5 g , tid , 7 d ) was started 1 d after SRP ( completed by 2 times in 7 d ) ; Group C , SRP alone [ probing depth ( PD ) , bleeding index ( BI ) and tooth mobility ] was examined .
-METHODS	The average full-mouth probing depth , the average full-mouth proximal probing depth ( pPD ) , the percentage of sites with PD > 5 mm ( PD > 5 mm % ) , the percentage of sites with proximal PD > 5 mm ( pPD > 5 mm % ) , the average bleeding index ( BI ) and the percentage of sites with bleeding on probing ( BOP % ) were calculated .
-METHODS	Clinical examinations were performed at baseline and 2 months post therapy .
-RESULTS	( 1 ) Compared with baseline conditions , all the subjects showed clinical improvements in all the parameters evaluated 2 months post therapy , P < 0.05 .
-RESULTS	( 2 ) Significant difference were observed in the average PD changes between Group A [ ( 2.15 0.42 ) mm ] , Group B [ ( 1.76 0.29 ) mm ] and Group C [ ( 1.57 0.33 ) mm ] , P < 0.05 .
-RESULTS	No significant difference was observed in the average PD changes between Group B and Group C , P = 0.354 .
-RESULTS	Significant differences were observed in the average pPD changes between Group A [ ( 2.45 0.43 ) mm ] and Group C [ ( 1.90 0.48 ) mm ] , P < 0.05 .
-RESULTS	No significant difference was observed in BI and BOP % changes between Group A , Group B and Group C.
-CONCLUSIONS	For patients with severe chronic periodontitis , it is safe and feasible to receive full-mouth SRP by 2 times within 1 week .
-CONCLUSIONS	The short-term ( 2 months ) advantages in PD changes are observed in patients receiving SRP and antibiotic usage at the same time comparing with patients using antibiotics after SRP or SRP alone .
-
-###25891304
-BACKGROUND	In a phase 1 dose-escalation study , combined inhibition of T-cell checkpoint pathways by nivolumab and ipilimumab was associated with a high rate of objective response , including complete responses , among patients with advanced melanoma .
-METHODS	In this double-blind study involving 142 patients with metastatic melanoma who had not previously received treatment , we randomly assigned patients in a 2:1 ratio to receive ipilimumab ( 3 mg per kilogram of body weight ) combined with either nivolumab ( 1 mg per kilogram ) or placebo once every 3 weeks for four doses , followed by nivolumab ( 3 mg per kilogram ) or placebo every 2 weeks until the occurrence of disease progression or unacceptable toxic effects .
-METHODS	The primary end point was the rate of investigator-assessed , confirmed objective response among patients with BRAF V600 wild-type tumors .
-RESULTS	Among patients with BRAF wild-type tumors , the rate of confirmed objective response was 61 % ( 44 of 72 patients ) in the group that received both ipilimumab and nivolumab ( combination group ) versus 11 % ( 4 of 37 patients ) in the group that received ipilimumab and placebo ( ipilimumab-monotherapy group ) ( P < 0.001 ) , with complete responses reported in 16 patients ( 22 % ) in the combination group and no patients in the ipilimumab-monotherapy group .
-RESULTS	The median duration of response was not reached in either group .
-RESULTS	The median progression-free survival was not reached with the combination therapy and was 4.4 months with ipilimumab monotherapy ( hazard ratio associated with combination therapy as compared with ipilimumab monotherapy for disease progression or death , 0.40 ; 95 % confidence interval , 0.23 to 0.68 ; P < 0.001 ) .
-RESULTS	Similar results for response rate and progression-free survival were observed in 33 patients with BRAF mutation-positive tumors .
-RESULTS	Drug-related adverse events of grade 3 or 4 were reported in 54 % of the patients who received the combination therapy as compared with 24 % of the patients who received ipilimumab monotherapy .
-RESULTS	Select adverse events with potential immunologic causes were consistent with those in a phase 1 study , and most of these events resolved with immune-modulating medication .
-CONCLUSIONS	The objective-response rate and the progression-free survival among patients with advanced melanoma who had not previously received treatment were significantly greater with nivolumab combined with ipilimumab than with ipilimumab monotherapy .
-CONCLUSIONS	Combination therapy had an acceptable safety profile .
-CONCLUSIONS	( Funded by Bristol-Myers Squibb ; ClinicalTrials.gov number , NCT01927419 . )
-
-###25241369
-OBJECTIVE	To study which variables are able to influence women 's experience of pain during diagnostic hysteroscopy .
-METHODS	Multivariate analysis ( phase II ) after a randomized , controlled trial ( phase I ) .
-METHODS	Endoscopic gynecologic center .
-METHODS	In phase I , 392 patients were analyzed .
-METHODS	Group A : 197 women with carbon dioxide ( CO2 ) ; group B : 195 women with normal saline .
-METHODS	In phase II , 392 patients were assigned to two different groups according to their pain experience as measured by a visual analogue scale ( VAS ) : group VAS > 3 ( 170 patients ) ; group VAS3 ( 222 patients ) .
-METHODS	Free-anesthesia diagnostic hysteroscopy performed using CO2 or normal saline as distension media .
-METHODS	Procedure time , VAS score , image quality , and side effects during and after diagnostic hysteroscopy .
-RESULTS	In phase I the median pain score in group A was 2 , whereas in group B it was 3 .
-RESULTS	In phase II the duration of the procedure , nulliparity , and the use of normal saline were significantly correlated with VAS > 3 .
-RESULTS	A higher presence of cervical synechiae was observed in the group VAS > 3 .
-RESULTS	The multivariate analysis revealed an inverse correlation between parity and a VAS > 3 , whereas the use of normal saline , the presence of synechiae in the cervical canal , and the duration of the hysteroscopy were all directly correlated to a VAS score > 3 .
-CONCLUSIONS	Pain in hysteroscopy is significantly related to the presence of cervical synechiae , to the duration of the procedure , and to the use of normal saline ; conversely , parity seems to have a protective role .
-BACKGROUND	NCT01873391 .
-
-###24508841
-OBJECTIVE	OCEANS , a randomized , placebo-controlled , phase III trial , found that adding bevacizumab to gemcitabine-carboplatin ( GC ) significantly improved investigator-determined progression-free survival ( PFS ) and objective response rate ( ORR ) in platinum-sensitive , recurrent ovarian cancer .
-OBJECTIVE	To evaluate the reliability of assessment of progression and objective response per RECIST , radiologic and clinical data were assessed by an independent review committee ( IRC ) .
-METHODS	Radiologic images and clinical data were provided prospectively to the IRC for all randomized patients ( N = 484 ) .
-METHODS	Data were reviewed in a blinded fashion per RECIST ( modified v1 .0 ) .
-METHODS	PFS and ORR were analyzed based on the IRC assessment .
-METHODS	Concordance between investigator - and IRC-assessed progression and objective response was assessed .
-RESULTS	The IRC analysis demonstrated a statistically significant increase in PFS ( hazard ratio [ HR ] = 0.451 ; 95 % confidence interval [ CI ] = 0.351 to 0.580 , p < 0.0001 ) consistent with the benefit reported by investigators ( HR = 0.484 ; 95 % CI = 0.388 to 0.605 , p < 0.0001 ) .
-RESULTS	The concordance rate , defined by agreement on progression status , was 74.2 % overall , and comparable between treatment arms ( bevacizumab , 75.2 % vs. placebo , 73.1 % ) .
-RESULTS	IRC-assessed ORR was significantly improved with bevacizumab ( bevacizumab , 74.8 % vs. placebo , 53.7 % ; p < 0.0001 ) , consistent with the investigator-assessed results .
-RESULTS	The concordance rate for objective response was 79.8 % overall , and comparable between treatment arms ( bevacizumab , 78.9 % vs. placebo , 80.6 % ) .
-CONCLUSIONS	IRC-determined results were highly consistent with those determined by investigators , demonstrating that bevacizumab plus GC provides a significant improvement in PFS and ORR .
-CONCLUSIONS	These results suggest that investigators can reliably assess disease progression and objective response in recurrent ovarian cancer using RECIST , without the necessity of a full IRC review .
-
-###26480545
-OBJECTIVE	To explore the impacts on the fine movement of upper extremity with flaccid paralysis in stroke treated with acupuncture and motor imagery .
-METHODS	Sixty-two cases of flaccid paralysis of upper extremity in stroke were randomized into an observation group ( 30 cases ) and a control group ( 32 cases ) .
-METHODS	In the control group , the conventional western medication and the passive movement of the extremity were applied .
-METHODS	Additionally , the penetrating needling technique was used at the head points [ penetrating needling from Baihui ( GV 20 ) to Taiyang ( EX-HN 5 ) ] and the local affected extremity [ penetrating needling from Jianyu ( LI 15 ) to Binao ( LI1 14 ) , from Quchi ( LI 11 ) to Shaohai ( HT 3 ) , from Waiguan ( TE 5 ) to Neiguan ( PC 6 ) , etc ] .
-METHODS	The needles were retained for 30 min .
-METHODS	In the observation group , on the basic treatment as the control group , during the needle retaining , the motor imagery therapy was supplemented .
-METHODS	The treatment was given once a day , 5 treatments a week , for 4 weeks totally in the either group .
-METHODS	The scores in the action research arm test ( ARAT ) and the modified Fugl-Meyer assessment ( FMA ) were recorded at the moment of enrollment , in 2 and 4 weeks of treatment , in the 6th and 8th weeks , as well as after 90 days separately .
-RESULTS	( 1 ) ARAT score : since the 2nd week , ARAT scores in the observation group were all improved significantly as compared with those in the control group at the each time points ( all P < 0.05 ) .
-RESULTS	In the observation group , the scores were improved significantly in the pair comparison at the time points ( all P < 0.05 ) .
-RESULTS	In the control group , the score in the 2nd week was not different significantly as compared with that before treatment ( P > 0.05 ) , but the scores at the rest time points were improved significantly in the pair comparison ( all P < 0.05 ) ; ( 2 ) FMA score : in the 2nd week and on the 90th day , FMA score in the observation group was higher significantly than those in the control group ( both P < 0.05 ) .
-RESULTS	In the observation group , the scores were all improved significantly in the pair comparison at the time points ( all P < 0.05 ) .
-RESULTS	In the control group , except that in comparison between the 90th day and the 8th week ( P > 0.05 ) , the results were all P < 0.05 at the rest time points .
-CONCLUSIONS	The early intervention of the combined therapy of acupuncture and motor imagery effectively promotes the recovery of the coordination function and the fine movement of upper extremity , especially the improvements of the fine movement in stroke at flaccid paralysis stage .
-CONCLUSIONS	The efficacy is better than the single acupuncture treatment .
-
-###25458336
-OBJECTIVE	This paper attempts to describe the patterns of exercise and the perceived benefits and barriers to exercise in an urban south Indian population .
-METHODS	Study participants were recruited from the baseline survey of the D-CLIP ( Diabetes Community Lifestyle Improvement Program ) .
-METHODS	Frequency , duration , type and location of exercise were assessed using a questionnaire , while a Likert type scale was used to assess perceived benefits of and barriers to exercise .
-METHODS	Quality of life was measured using the EQ-5D .
-RESULTS	Out of 1281 participants ( 63.7 % males ) , 24.1 % reported doing 150min of exercise/week ( `` exercisers '' ) compared to 75.9 % `` non-exercisers '' .
-RESULTS	Exercisers were significantly older ( 47 vs. 43 years ) , better educated ( 68.8 % vs. 60 % ) , had a higher monthly income ( 41 % vs. 29.2 % ) , consumed more fruits ( 38.2 % vs. 25.6 % ) and vegetables ( 84.1 % vs. 77.7 % ) and had better perceived state of health ( 81.1 % vs. 76.8 % ) , compared to non-exercisers .
-RESULTS	Exercisers had significantly lower HOMA-IR , higher Matsuda index and lower prevalence of low HDL cholesterol compared to non-exercisers .
-RESULTS	However , there were no significant differences in cardio-metabolic risk factors like diabetes , hypertension and obesity between the two groups .
-RESULTS	Walking was the most common type of exercise .
-RESULTS	Both exercisers and non-exercisers perceived the benefits of exercising , but barriers weighed more heavily on exercise behaviour .
-CONCLUSIONS	Urgent steps are needed to improve overall exercise levels in India by addressing barriers and improving the quality of exercise performed so as to enhance overall metabolic health .
-
-###25877139
-OBJECTIVE	To investigate if a six-year intensive lifestyle intervention in people with pre-diabetes lead to reduction of cardiovascular events and cardiovascular disease ( CVD ) mortality in subsequent 23 years .
-METHODS	Five hundreds and nineteen subjects with normal glucose tolerance ( NGT ) and 577 subjects with impaired glucose tolerance ( IGT ) in Da Qing city were recruited in the study in 1986 .
-METHODS	The IGT subjects randomly assigned to either the no-intervention group or one of three lifestyle intervention groups ( diet , exercise , or diet plus exercise ) to receive a 6-year lifestyle intervention .
-METHODS	In 2009 , the participants were followed up to assess the primary outcomes of cardiovascular events and CVD mortality by a questionnaire and medical records .
-RESULTS	Subjects in IGT no-intervention group had the highest incidences of cardiovascular events ( 44.44 % ) and CVD mortality ( 20.00 % ) , while those in NGT group had the lowest incidences of cardiovascular events ( 29.59 % ) and CVD mortality ( 7.52 % ) after 23-year follow-up .
-RESULTS	The incidences of cardiovascular events and CVD mortality in IGT intervention subjects were 37.84 % and 12.53 % , respectively .
-RESULTS	The multivariable analyses showed that , after controlling of age , gender , BMI smoking , blood pressure and cardiovascular event at baseline , the CVD mortality and incidence of cardiovascular events in IGT no-intervention group was 1.89 ( HR = 1.89 , 95 % CI 1.11-3 .22 , P = 0.02 ) and 1.38 ( HR = 1.38 , 95 % CI 1.01-1 .90 , P = 0.04 ) times of those in NGT group .
-RESULTS	However , the CVD mortality and incidence of cardiovascular events were not different in the IGT intervention group compared with those in the NGT group ( HR = 1.39 , 95 % CI 0.89-2 .18 , P = 0.15 and HR = 1.25 , 95 % CI 0.98-1 .59 , P = 0.07 , respectively ) .
-CONCLUSIONS	Subjects with IGT were at high risk for cardiovascular events and mortality .
-CONCLUSIONS	A six-year lifestyle intervention in this population can reduce both the incidence of cardiovascular event and CVD mortality .
-
-###26287302
-BACKGROUND	Anesthesia induction using propofol ( 3 mg/kg ) and remifentanil ( 2 g/kg ) without the use of muscle relaxants has been associated with a lower incidence of successful intubation .
-BACKGROUND	Dexmedetomidine has been found to effectively decrease the requirements for propofol and remifentanil and to attenuate the hemodynamic response to intubation .
-BACKGROUND	Therefore , in this study , we examined intubating conditions and hemodynamic changes in children after induction with dexmedetomidine ( 1 g/kg ) combined with propofol ( 3 mg/kg ) and remifentanil ( 2 g/kg ) .
-METHODS	This randomized , double-blinded , and placebo-controlled study included 60 ASA physical status I children aged 5 to 10 years .
-METHODS	The children were randomly allocated to a dexmedetomidine group ( group D ) or a placebo group ( group P ) .
-METHODS	After IV administration of atropine ( 0.01 mg/kg ) , anesthesia was induced with an infusion of dexmedetomidine ( 1 g/kg ) over 2 minutes for group D , whereas normal saline was infused for group P. Propofol ( 3 mg/kg ) was then injected IV over 20 to 30 seconds , followed by an infusion of remifentanil ( 2 g/kg ) over 1 minute for both groups .
-METHODS	One minute later , laryngoscopy and tracheal intubation were performed .
-RESULTS	For group D and group P , tracheal intubation was successful in 90 % ( 27/30 ) and 53 % ( 16/30 ) of patients ( P = 0.0034 ) , respectively .
-RESULTS	Excellent conditions were present in 22 of 27 and 8 of 16 of intubations , respectively , resulting in an overall incidence of excellent conditions of 73 % ( 22/30 ) and 27 % ( 8/30 ) , respectively ( P = 0.0007 ) .
-RESULTS	Systolic blood pressure significantly increased after the IV injection of dexmedetomidine compared with baseline readings ( P = 0.012 , with a confidence interval of 2-22 mm Hg ) .
-CONCLUSIONS	A single dose of dexmedetomidine ( 1 g/kg ) improved intubation conditions in children after induction with propofol ( 3 mg/kg ) and remifentanil ( 2 g/kg ) without muscle relaxants .
-CONCLUSIONS	Dexmedetomidine did not affect the hemodynamic response to intubation .
-
-###24274912
-BACKGROUND	Carbapenem-resistant Enterobacteriaceae ( CRE ) are emerging .
-BACKGROUND	In attempt to eradicate CRE colonization , we conducted a semirandomized , prospective , controlled trial using oral nonabsorbable antibiotics .
-METHODS	Consecutive hospitalized CRE carriers were studied .
-METHODS	Patients whose rectal isolates were gentamicin sensitive but colistin resistant were treated with gentamicin .
-METHODS	Patients whose isolates were colistin sensitive but gentamicin resistant were treated with colistin .
-METHODS	Patients whose isolates were sensitive to both drugs were randomized to 3 groups of oral antibiotic treatment : gentamicin , colistin , or both .
-METHODS	Patients whose isolates were resistant to both drugs , and those who did not consent , were followed for spontaneous eradication .
-RESULTS	One hundred fifty-two patients were included ; 102 were followed for spontaneous eradication for a median duration of 140 days ( controls ) , and 50 received 1 of the 3 drug regimens : gentamicin , 26 ; colistin , 16 ; both drugs , 8 , followed for a median duration of 33 days .
-RESULTS	Eradication rates in the 3 treatment groups were 42 % , 50 % , and 37.5 % , respectively , each significantly higher than the 7 % spontaneous eradication rate in the control group ( P < .001 , P < .001 , and P = .004 , respectively ) with no difference between the regimens .
-RESULTS	No significant adverse effects were observed .
-CONCLUSIONS	Oral antibiotic treatment with nonabsorbable drugs to which CRE is susceptible appears to be an effective and safe for eradication of CRE colonization and , thereby , may reduce patient-to-patient transmission and incidence of clinical infection with this difficult-to-treat organism .
-
-###25733634
-BACKGROUND	Energy expenditure ( EE ) increases with overfeeding , but it is unclear how rapidly this is related to changes in body composition , increased body weight , or diet .
-OBJECTIVE	The objective was to quantify the effects of excess energy from fat or protein on energy expenditure of men and women living in a metabolic chamber .
-METHODS	We conducted a randomized controlled trial in 25 participants who ate 40 % excess energy for 56 d from 5 % , 15 % , or 25 % protein diets .
-METHODS	Twenty-four-hour EE ( 24EE ) and sleeping EE ( SleepEE ) were measured on days 1 , 14 , and 56 of overfeeding and on day 57 while consuming the baseline diet ( usually day 57 ) .
-METHODS	Metabolic and molecular markers of muscle metabolism were measured in skeletal muscle biopsy specimens .
-RESULTS	In the low-protein diet group whose excess energy was fat , the 24EE and SleepEE did not increase during the first day of overfeeding .
-RESULTS	When extra energy contained protein , both 24EE and SleepEE increased in relation to protein intake ( r = 0.50 , P = 0.02 ) .
-RESULTS	The 24EE over 8 wk in all 3 groups was correlated with protein intake ( r = 0.60 , P = 0.004 ) but not energy intake ( r = 0.16 ; P = 0.70 ) .
-RESULTS	SleepEE was unchanged by overfeeding in the low-protein diet group , and baseline surface area predicted increased 24EE in this group .
-RESULTS	Protein and fat oxidation were reciprocally related during overfeeding .
-RESULTS	Observed 24EE was higher than predicted on days 1 ( P 0.05 ) , 14 ( P = 0.0001 ) , and 56 ( P = 0.0007 ) .
-RESULTS	There was no relation between change in fat mass and change in EE .
-CONCLUSIONS	Excess energy , as fat , does not acutely increase 24EE , which rises slowly as body weight increases .
-CONCLUSIONS	Excess energy as protein acutely stimulates 24EE and SleepEE .
-CONCLUSIONS	The strongest relation with change in 24EE was the change in energy expenditure in tissue other than muscle or fat-free mass .
-
-###24571163
-OBJECTIVE	This article describes a study that aimed to validate the Self-care in Chronic Conditions Partners in Health Scale instrument in the Mexican population .
-OBJECTIVE	The instrument has been validated in Australia for use as a screening tool by primary healthcare professionals to assess the self-care skills and abilities of people with a chronic illness .
-METHODS	Validation was conducted using baseline data for 552 people with diabetes , hypertension and cancer aged 18 or older who were users of healthcare centres in Tampico , Tamaulipas , Mexico .
-RESULTS	Results show high reliability and validity of the instrument and three themes were identified : knowledge , adherence , and dealing with and managing side effects .
-CONCLUSIONS	The findings suggest the scale is useful as a generic self-rated clinical tool for assessing self-management in a range of chronic conditions , and provides an outcome measure for comparing populations and change in patient self-management knowledge and behaviour .
-CONCLUSIONS	The authors recommend validating the scale in other Latin-American settings with more research into the effect of gender on self - management .
-
-###24795284
-BACKGROUND	Non-invasive near-infrared spectroscopy ( NIRS ) offers the possibility to determine regional cerebral oxygen saturation ( rSO2 ) in patients with cardiac arrest .
-BACKGROUND	Limited data from recent studies indicate a potential for early prediction of neurological outcome .
-METHODS	Sixty cardiac arrest patients were prospectively enrolled , 22 in-hospital cardiac arrest ( IHCA ) and 38 out-of-hospital cardiac arrest ( OHCA ) patients respectively .
-METHODS	NIRS of frontal brain was started after return of spontaneous circulation ( ROSC ) during admission to ICU and was continued until normothermia .
-METHODS	Outcome was determined at ICU discharge by the Pittsburgh Cerebral Performance Category ( CPC ) and 6 months after cardiac arrest .
-RESULTS	A good outcome ( CPC 1-2 ) was achieved in 23 ( 38 % ) patients , while 37 ( 62 % ) had a poor outcome ( CPC 3-5 ) .
-RESULTS	Patients with good outcome had significantly higher rSO2 levels ( CPC 1-2 : rSO2 68 % ; CPC 3-5 : rSO2 58 % ; p < 0.01 ) .
-RESULTS	For good and poor outcome median rSO2 within the first 24h period was 66 % and 59 % respectively and for the following 16h period 68 % and 59 % ( p < 0.01 ) .
-RESULTS	Outcome prediction by area of rSO2 below a critical threshold of rsO2 = 50 % within the first 40h yielded 70 % specificity and 86 % sensitivity for poor outcome .
-CONCLUSIONS	On average , rSO2 within the first 40h after ROSC is significantly lower in patients with poor outcome , but rSO2 ranges largely overlap between outcome groups .
-CONCLUSIONS	Our data indicate limited potential for prediction of poor outcome by frontal brain rSO2 measurements .
-
-###24637345
-OBJECTIVE	This study aimed to examine whether reductions in sitting time through alternating 30-min bouts of sitting and standing can reduce postprandial glucose , insulin , and triglyceride responses .
-METHODS	Twenty-three overweight/obese sedentary office workers ( 17 males and six females ; mean SD : age , 48.2 7.9 yr ; body mass index , 29.6 4.0 kg m ( -2 ) ) undertook two short-term ( 5 d ) experimental conditions in an equal , randomized ( 1:1 ) order .
-METHODS	In a simulated office environment , participants performed typical occupational tasks for 8 h d ( -1 ) while in a 1 ) seated work posture ( control condition ) or 2 ) interchanging between a seated and standing work posture every 30 min using an electric , height-adjustable workstation ( intervention condition ) .
-METHODS	Fasting and postprandial blood samples after a mixed test drink were collected hourly for 4 h on days 1 and 5 of each condition to assess serum insulin , plasma glucose , and triglycerides .
-METHODS	Dietary intake ( kJ d ( -1 ) ) and physical activity were standardized during each condition .
-METHODS	The trial was registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12611000632998 ) .
-RESULTS	After adjustment for time ( days 1 and 5 ) , incremental area under the analyte time curve differed significantly between conditions for plasma glucose ( P = 0.007 ) but not for serum insulin or plasma triglycerides .
-RESULTS	Adjusted mean glucose incremental area under the analyte time curve was lowered by 11.1 % after the intervention condition ( 6.38 mM h ( -1 ) ( confidence interval , 5.04-7 .71 ) ) relative to the control condition ( 7.18 mM h ( -1 ) ( confidence interval , 5.85-8 .52 ) ) .
-RESULTS	No temporal changes ( days 1 vs 5 ) between conditions were observed .
-CONCLUSIONS	Alternating standing and sitting in 30-min bouts results in modest beneficial effects on postprandial glucose responses in overweight/obese office workers .
-
-###24631086
-BACKGROUND	Pneumococcal conjugate vaccines ( PCV ) reduce disease due to Streptococcus pneumoniae .
-BACKGROUND	We aimed to determine the efficacy of different PCV schedules in Gambian children .
-METHODS	We reanalysed data from a randomised placebo-controlled trial .
-METHODS	Infants aged 6-51 weeks were allocated to three doses of nine-valent PCV ( n = 8718 ) or placebo ( n = 8719 ) and followed until age 30 months .
-METHODS	We categorised participants to compare : ( a ) a first dose at age 6 or 10 weeks , ( b ) intervals of 1 or 2 months between doses , and ( c ) different intervals between second and third doses .
-METHODS	The primary endpoint was first episode of radiologic pneumonia ; other endpoints were hospitalisation and mortality .
-METHODS	Using the placebo group as the reference population , Poisson regression models were used with follow-up after the first dose to estimate the efficacy of each schedule and from age 6 weeks to estimate the incidence rate difference between schedules .
-RESULTS	Predicted efficacy in the groups aged 6 weeks ( n = 2467 , 154 events ) or 10 weeks ( n = 2420 , 106 events ) at first dose against radiologic pneumonia were 32 % ( 95 % CI 19-43 % ) and 33 % ( 95 % CI 21-44 % ) , against hospitalisation 14 % ( 95 % CI 3-23 % ) and 17 % ( 95 % CI 7-26 % ) , and against mortality 17 % ( 95 % CI -3 to 33 % ) and 16 % ( 95 % CI -3 to 32 % ) respectively .
-RESULTS	Predicted efficacy in the groups with intervals of 1 month ( n = 2701 , 133 events ) or 2 months ( n = 1351 , 58 events ) between doses against radiologic pneumonia were 33 % ( 95 % CI 20-44 % ) and 36 % ( 95 % CI 24-46 % ) , against hospitalisation 15 % ( 95 % CI 5-24 % ) and 18 % ( 95 % CI 8-27 % ) , and against mortality 17 % ( 95 % CI -2 to 33 % ) and 13 % ( 95 % CI -8 to 29 % ) respectively .
-RESULTS	Efficacy did not differ by interval between second and third doses , nor did the incidence rate difference between schedules .
-CONCLUSIONS	We found no evidence that efficacy or effectiveness of PCV9 differed when doses were given with modest variability around the scheduled ages or intervals between doses .
-
-###24768303
-BACKGROUND	Data are scarce on the advantage of ultrasound-guided spinal anaesthesia in patients with easily identifiable bony landmarks .
-BACKGROUND	In this study , we compared the use of ultrasound to the landmark method in patients with no anticipated technical difficulty , presenting for caesarean delivery under spinal anaesthesia .
-METHODS	A total of 150 pregnant women were recruited in this randomized , controlled study .
-METHODS	Ultrasound examination and spinal anaesthesia were performed by three anaesthetists with experience in ultrasound-guided neuraxial block .
-METHODS	Patients were randomized to either the Ultrasound Group ( n = 75 ) or the Landmark Group ( n = 75 ) .
-METHODS	In both groups the level of L3-4 or L4-5 was identified by ultrasound ( transverse and longitudinal approach ) or palpation .
-METHODS	The primary outcome was the procedure time , measured from the time of skin puncture by the introducer to the time of viewing cerebrospinal fluid at the hub of the spinal needle .
-METHODS	Secondary outcomes were the number of skin punctures , number of passes , and incidence of successful spinal blockade .
-RESULTS	The average procedure time , number of skin punctures and needle passes , were similar in both groups .
-RESULTS	The number of patients with successful spinal anaesthesia after one puncture was not statistically different between the groups .
-CONCLUSIONS	The present results indicate that when performed by anaesthetists experienced in both ultrasound and landmark techniques , the use of ultrasound does not appear to increase the success rate of spinal anaesthesia , or reduce the procedure time or number of attempts in obstetric patients with easily palpable spines .
-
-###25065710
-BACKGROUND	Low-dose computed tomography ( LDCT ) lung screening has been associated with a 20 % reduction in lung cancer mortality .
-BACKGROUND	A major barrier to the adoption of lung screening is the potential negative psychological impact of a false-positive ( FP ) screen , occurring in 20 % to 50 % of those screened .
-BACKGROUND	The objective of this study was to assess the impact of abnormal findings on health-related quality of life ( HRQoL ) and anxiety in the American College of Radiology ( ACRIN ) / National Lung Screening Trial ( NLST ) .
-METHODS	The NLST was a randomized screening trial comparing LDCT with chest X-ray screening ( CXR ) .
-METHODS	This study was part of the original protocol .
-METHODS	A total of 2812 participants at 16 of 23 ACRIN sites who had baseline HRQoL assessments were asked to complete the Short Form-36 and the State Trait Anxiety Inventory ( form Y-1 ) questionnaires to assess short-term ( 1 month ) and long-term ( 6 months ) effects of screening .
-METHODS	FP were lung cancer-free at 1 year , and true-positives ( TP ) were not .
-RESULTS	Of the total participants , 1024 ( 36.4 % ) participants were FP , 63 ( 2.2 % ) were TP , 344 ( 12.2 % ) had significant incidental findings ( SIFs ) , and 1381 ( 49.1 % ) had negative screens .
-RESULTS	Participants had been randomized to LDCT ( n = 1947 ) and CXR ( n = 865 ) .
-RESULTS	Short-term and long-term HRQoL and state anxiety did not differ across participants with FP , SIF , or negative screens .
-RESULTS	Short-term and long-term HRQoL were lower and anxiety was higher for TP participants compared to participants with FP , SIF , and negative screens .
-CONCLUSIONS	In a large multicenter lung screening trial , participants receiving a false-positive or SIF screen result experienced no significant difference in HRQoL or state anxiety at 1 or at 6 months after screening relative to those receiving a negative result .
-
-###24238679
-OBJECTIVE	To determine if brief primary care interventions can affect children 's media viewing habits and exposure to violence .
-METHODS	English - and Spanish-speaking parents of 2 - to 12-year-old children presenting to a pediatric primary care clinic participated in a randomized controlled trial .
-METHODS	There were 2 intervention groups ; one group viewed 5 minutes from the Play Nicely program and another received a handout , `` Pulling the Plug on TV Violence . ''
-METHODS	There were 2 control groups ; the primary control group received standard primary care , and the alternative control group viewed a program about obesity prevention .
-METHODS	The outcome measure was parental report of changes in media viewing habits and changes in exposure to violence .
-RESULTS	A total of 312 of 443 parents who were randomized completed a 2-week follow-up survey .
-RESULTS	Compared with the primary control group , parents in the video intervention group were more likely to report a change in their children 's media viewing habits ( odds ratio [ OR ] 3.29 ; 95 % confidence interval [ CI ] 1.66-6 .51 ) and a change in their children 's exposure to violence ( OR 4.26 ; 95 % CI 1.95-9 .27 ) .
-RESULTS	Compared with the primary control group , parents in the handout group were more likely to report a change in their children 's media viewing habits ( OR 4.35 ; 95 % CI 2.20-8 .60 ) and a change in their children 's exposure to violence ( OR 3.35 ; 95 % CI 1.52-7 .35 ) .
-CONCLUSIONS	Brief primary care interventions can affect children 's media viewing habits and children 's exposure to violence .
-CONCLUSIONS	These results have implications for how to improve primary care services related to decreasing children 's media exposure and violence prevention .
-
-###24928948
-OBJECTIVE	Dual-chamber implantable cardioverter-defibrillators ( ICDs ) may improve specificity and reduce the risk of inappropriate shocks , and enhance atrial arrhythmia ( AT/AF ) detection to permit stroke prevention compared with single-chamber ICDs , but at additional expense and risk .
-RESULTS	Patients ( n = 100 ) receiving primary prevention ICDs at two USA and two Israeli centres were randomized to dual-chamber or single-chamber devices between December 2008 and December 2010 and were followed for 1 year .
-RESULTS	Programming in both groups included : delayed detection to avoid therapy for non-sustained episodes ; high detection cut-off rates to avoid treating slower , better tolerated arrhythmias ; minimized right ventricular pacing ; and routine use of supraventricular-ventricular tahcycardia discriminators and antitachycardia pacing .
-RESULTS	The primary outcome was the proportion of patients with inappropriate shocks .
-RESULTS	One patient in each group ( 2 % ) received inappropriate shocks ( P = 1.00 ) .
-RESULTS	Death occurred in two patients in the single-chamber arm , and in none of the patients in the dual-chamber arm ( P = 0.15 ) .
-RESULTS	New AT/AF was detected in 12 patients ( 24 % ) in the dual-chamber group , vs. no patients in the single-chamber group ( P < 0.001 ) .
-RESULTS	Among US participants , the mean cost of dual - vs. single-chamber ICD implantation was $ 16 579 vs. $ 14 249 , respectively ( P < 0.001 ) ; there was no difference in the quality of life ( EQ-5D index difference 0.013 , P = 0.769 ; EQ VAS difference 3.3 , P = 0.49 ) .
-CONCLUSIONS	When optimal programming is utilized , inappropriate shocks are rare in primary prevention patients with both single - and dual-chamber ICDs .
-CONCLUSIONS	The routine use of dual-chamber ICDs increases the expense without reducing inappropriate shocks or improving the quality of life at 1 year .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00787800 .
-
-###25733467
-BACKGROUND	The zinc content of maize , a major global food staple , is generally insufficient alone to meet the requirements of young children .
-OBJECTIVE	The primary objective of this study was to determine whether substitution of biofortified maize ( 34 g zinc/g grain ) for control maize ( 21 g zinc/g ) was adequate to meet zinc physiologic requirements in young children for whom maize was the major food staple .
-OBJECTIVE	A secondary objective was to compare total daily zinc absorption when maize flour was fortified with zinc oxide to a total concentration of 60 g zinc/g .
-METHODS	Participants included 60 rural Zambian children with a mean age of 29 mo who were randomly assigned to receive 1 of 3 maize types ( control , biofortified , or fortified ) all of which were readily consumed ( > 100 g on 1 d ) .
-METHODS	Total daily zinc intake ( from maize and low-zinc relish ) was determined from duplicate diet collections .
-METHODS	Multiplication by fractional absorption of zinc , measured by a dual isotope ratio technique , determined the total daily zinc absorption on the day the test meals were given .
-RESULTS	The mean SD total daily zinc intake ( milligrams per day ) from the biofortified maize ( 5.0 2.2 ) was higher ( P < 0.0001 ) than for the control maize ( 2.3 0.9 ) .
-RESULTS	Intake of zinc from the fortified maize ( 6.3 2.6 ) did not differ from the biofortified maize .
-RESULTS	Fractional absorption of zinc from control maize ( 0.28 0.10 ) did not differ from the biofortified maize ( 0.22 0.06 ) .
-RESULTS	Total daily absorption of zinc ( milligrams per day ) from the biofortified maize ( 1.1 0.5 ) was higher ( P = 0.0001 ) than for the control maize ( 0.6 0.2 ) , but did not differ from the fortified maize ( 1.2 0.4 ) .
-CONCLUSIONS	These results indicate that feeding biofortified maize can meet zinc requirements and provide an effective dietary alternative to regular maize for this vulnerable population .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT02208635 .
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-###25244948
-BACKGROUND	Duck viral hepatitis ( DVH ) is an acute disease of young ducklings with few convenient and effective veterinary drugs to treat .
-BACKGROUND	In pathology , present study mainly focused on the immune mechanism , but very few studies have concerned with the role of oxidative stress in the pathogenesis of DVH .
-BACKGROUND	To study the antioxidative and hepatoprotective effects of icariin and its phosphorylated derivative against DVH , we prepared phosphorylated icariin ( p-icariin ) using the sodium trimetaphosphate-sodium tripolyphosphate method .
-BACKGROUND	Ducklings were drunk with icariin and p-icariin after being challenged with duck hepatitis virus 1 ( DHV-1 ) .
-BACKGROUND	We recorded the number of dead ducklings , gross pathological changes in the liver , and changes in indices of oxidative stress and liver injury .
-BACKGROUND	The correlations between these indices were also analyzed .
-RESULTS	Exposure to DHV-1 induced significant oxidative damage in ducklings .
-RESULTS	Administration of icariin or p-icariin attenuated liver pathological injury and significantly increased the survival rate , with better outcomes in ducklings treated with p-icariin than in those treated with icariin .
-RESULTS	Icariin and p-icariin also attenuated the changes in oxidative stress and liver injury .
-RESULTS	We found positive correlations among indices of oxidative stress ( malondialdehyde and inducible nitric oxide synthase ) and liver injury ( alanine aminotransferase , alkaline phosphatase , and lactate dehydrogenase ) , suggesting that DHV-1 causes significant oxidative damage , which is related to the extent of hepatic injury .
-CONCLUSIONS	Icariin and p-icariin improved the survival and attenuated oxidative stress and liver dysfunction induced by DHV-1 .
-CONCLUSIONS	These outcomes were better in ducklings treated with p-icariin than in those treated by icariin .
-CONCLUSIONS	The clinical effects of both components were related to their antioxidant activities .
-
-###25015535
-BACKGROUND	The evidence for choices between antipsychotics for children and adolescents with schizophrenia and other psychotic disorders is limited .
-BACKGROUND	The main objective of the Tolerability and Efficacy of Antipsychotics ( TEA ) trial is to compare the benefits and harms of quetiapine versus aripiprazole in children and adolescents with psychosis in order to inform rational , effective and safe treatment selections .
-METHODS	The TEA trial is a Danish investigator-initiated , independently funded , multi-centre , randomised , blinded clinical trial .
-METHODS	Based on sample size estimation , 112 patients aged 12-17 years with psychosis , antipsychotic-nave or treated for a limited period are , 1:1 randomised to a 12 - week , double-blind intervention with quetiapine versus aripiprazole .
-METHODS	Effects on psychopathology , cognition , health-related quality of life , and adverse events are assessed 2 , 4 , and 12 weeks after randomisation .
-METHODS	The primary outcome is change in the positive symptom score of the Positive and Negative Syndrome Scale .
-METHODS	The recruitment period is 2010-2014 .
-CONCLUSIONS	Antipsychotics are currently the only available pharmacologic treatments for psychotic disorders .
-CONCLUSIONS	However , information about head-to-head differences in efficacy and tolerability of antipsychotics are scarce in children and adolescents .
-CONCLUSIONS	The TEA trial aims at expanding the evidence base for the use of antipsychotics in early onset psychosis in order to inform more rational treatment decisions in this vulnerable population .
-CONCLUSIONS	Here , we account for the trial design , address methodological challenges , and discuss the estimation of sample size .
-BACKGROUND	ClinicalTrials.gov : NCT01119014 .
-
-###25163902
-OBJECTIVE	To compare DBT and FFDM in the classification of microcalcification clusters ( MCs ) using BI-RADS .
-METHODS	This Institutional Review Board-approved study was undertaken in three centres .
-METHODS	A total of 107 MCs evaluated with both DBT and FFDM were randomised for prospective reading by six experienced breast radiologists and classified using BI-RADS .
-RESULTS	The benign/malignant ratio of MC was 66/41 .
-RESULTS	Of 11/107 discordant results , DBT classified MCs as R2 whereas FFDM classified them as R3 in 9 and R4 in 2 .
-RESULTS	Three of these ( 3/107 = 2.8 % ) were malignant ; 8 ( 7.5 % ) were nonmalignant and were correctly classified as R2 on DBT but incorrectly classified as R3 on FFDM .
-RESULTS	Estimated sensitivity and specificity , respectively , were 100 % ( 95 % CI : 91 % to 100 % ) and 94.6 % ( 95 % CI : 86.7 % to 98.5 % ) for FFDM and 91.1 % ( 95 % CI : 78.8 % to 97.5 % ) and 100 % ( 95 % CI : 94.8 % to 100 % ) for DBT .
-RESULTS	Overall intra - and interobserver agreements were 0.75 ( 95 % CI : 0.61-0 .84 ) and 0.73 ( 95 % CI : 0.62-0 .78 ) .
-CONCLUSIONS	Most MCs are scored similarly on FFDM and DBT .
-CONCLUSIONS	Although a minority ( 11/107 ) of MCs are classified differently on FFDM ( benign MC classified as R3 ) and DBT ( malignant MC classified as R2 ) , this may have clinical relevance .
-CONCLUSIONS	The BI-RADS classification of MC differs for FFDM and DBT in 11/107 cases DBT assigned lower BI-RADS classes compared to FFDM in 11 clusters In 4/107 DBT may have missed some malignant and high-risk lesions In 7/107 the ` underclassification ' on DBT was correct , potentially avoiding unnecessary biopsies DBT may miss a small proportion of malignant lesions .
-
-###24374246
-OBJECTIVE	To compare the use of low pneumoperitoneum pressure ( LPP ; 8mm Hg ) vs standard pneumoperitoneum pressure ( SPP ; 12mm Hg ) during mini-laparoscopic hysterectomy ( MLH ) .
-METHODS	Randomized controlled trial ( Canadian Task Force classification I ) .
-METHODS	Tertiary care center .
-METHODS	Forty-two consecutive women scheduled to undergo MLH to treat benign uterine disease .
-METHODS	Women were randomly selected to undergo MLH using LPP ( n = 20 ) or SPP ( n = 22 ) .
-METHODS	MLH was performed via 3-mm ancillary ports .
-RESULTS	The primary outcome was to evaluate changes in abdominal and shoulder-tip pain via a 100-mm visual analog scale at 1 , 3 , and 24hours postoperatively .
-RESULTS	All procedures were completed via mini-laparoscopy without the need to increase intra-abdominal pressure or convert to conventional laparoscopy or open surgery .
-RESULTS	Intraoperatively , 1 episode of severe bradycardia occurred in the LPP group , whereas no intraoperative complications were recorded in the SPP group ( p = .47 ) .
-RESULTS	No postoperative complications were recorded ( p > .99 ) .
-RESULTS	Abdominal pain was similar between groups at each time point .
-RESULTS	Incidence and intensity of shoulder-tip pain at 1 and 3hours postoperatively was lower in the LPP group than in the SPP group ( p < .05 ) , whereas no between-group differences were observed at 24hours ( p > .05 ) .
-RESULTS	Rescue analgesic requirement did not differ statistically between the LPP and SPP groups ( 20 % vs 41 % , respectively ; p = .19 ; odds ratio , 2.7 ; 95 % confidence interval , 0.69-11 .08 ) .
-CONCLUSIONS	In experienced hands , use of LPP is safe and feasible .
-CONCLUSIONS	During performance of MLH , compared with SPP , LPP is asimple method that offers advantages of less shoulder-tip pain .
-
-###24377216
-OBJECTIVE	To verify the clinical efficacy of shu-stream point acupuncture combined with fire needle therapy in the treatment of hand osteoarthritis .
-METHODS	Eighty cases were randomized into an acupuncture group ( shu-stream point acupuncture combined with fire needle therapy ) and a medication group ( votalin emulgel ) .
-METHODS	For the 42 cases in the acupuncture group , acupuncture at shu-stream points on the three yang meridians of the hand including Sanjian ( LI 3 ) , Zhongzhu ( TE 3 ) , Houxi ( SI 3 ) and fire needle at Ashi points were applied , the treatments were given once every other day , 15 times as a treatment course .
-METHODS	For the 38 cases in the medication group , votalin emulgel was prescribed for local embrocation , twice a day , 30 days as a treatment course .
-METHODS	The visual analogue scale ( VAS ) of arthralgia , joint function score and the duration of morning stiffness , joint tenderness , swelling were observed before and after treatment in both groups .
-RESULTS	After two courses of clinical treatment , the VAS score of arthralgia , joint function score and the duration of morning stiffness , joint tenderness , swelling were statistically significant differences as compared with before treatment ( all P < 0.01 ) , the efficacy in the acupuncture group was superior to that in the medication group ( all P < 0.01 ) .
-RESULTS	The cured-markedly effective rate and total effective rate were 61.9 % ( 26/42 ) and 95.2 % ( 40/42 ) in the acupuncture group , and 36.8 % ( 14/38 ) and 76.3 % ( 29/38 ) in the medication group respectively , with statistically significant differences between the two groups ( both P < 0.05 ) .
-CONCLUSIONS	Shu-stream point acupuncture combined with fire needle therapy achieves a significant efficacy in the treatment of hand osteoarthritis .
-
-###24331152
-BACKGROUND	The comparative outcome with GreenLight ( GL ) photoselective vaporisation of the prostate and transurethral resection of the prostate ( TURP ) in men with lower urinary tract symptoms due to benign prostatic obstruction ( BPO ) has been questioned .
-OBJECTIVE	The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS ( XPS ) to TURP for International Prostate Symptom Score ( IPSS ) and maximum flow rate ( Qmax ) at 6 mo and the proportion of patients who were complication free .
-METHODS	Prospective randomised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO .
-METHODS	180-W GL XPS system or TURP .
-METHODS	Measurements used were IPSS , Qmax , prostate volume ( PV ) , postvoid residual ( PVR ) and complications , perioperative parameters , and reintervention rates .
-METHODS	Noninferiority was evaluated using one-sided tests at the 2.5 % level of significance .
-METHODS	The statistical significance of other comparisons was assessed at the ( two-sided ) 5 % level .
-CONCLUSIONS	The study demonstrated the noninferiority of XPS to TURP for IPSS , Qmax , and complication-free proportion .
-CONCLUSIONS	PV and PVR were comparable between groups .
-CONCLUSIONS	Time until stable health status , length of catheterisation , and length of hospital stay were superior with XPS ( p < 0.001 ) .
-CONCLUSIONS	Early reintervention rate within 30 d was three times higher after TURP ( p = 0.025 ) ; however , the overall postoperative reintervention rates were not significantly different between treatment arms .
-CONCLUSIONS	A limitation was the short follow-up .
-CONCLUSIONS	XPS was shown to be noninferior ( comparable ) to TURP in terms of IPSS , Qmax , and proportion of patients free of complications .
-CONCLUSIONS	XPS results in a lower rate of early reinterventions but has a similar rate after 6 mo. .
-BACKGROUND	ClinicalTrials.gov , identifier NCT01218672 .
-
-###24336012
-BACKGROUND	Traditional cardiovascular risk factors lead to endothelial injury and activation of leukocytes and platelets that initiate and propagate atherosclerosis .
-BACKGROUND	We proposed that clopidogrel therapy in patients with stable coronary artery disease imparts a pleiotropic effect that extends beyond antiplatelet aggregation to other atheroprotective processes .
-METHODS	Forty-one subjects were randomized in a double-blind , placebo-controlled , crossover study to receive either clopidogrel 75 mg daily or placebo for 6 weeks and then transitioned immediately to the other treatment for an additional 6 weeks .
-METHODS	We assessed ( 1 ) endothelial function as flow-mediated dilation of the brachial artery , ( 2 ) arterial stiffness and central augmentation index using applanation tonometry , ( 3 ) vascular function as fingertip reactive hyperemia index , ( 4 ) inflammation by measuring plasma CD40 ligand and serum high-sensitivity c-reactive protein levels , ( 5 ) oxidative stress by measuring plasma aminothiols , and ( 6 ) circulating progenitor cells , at baseline and at the end of each 6-week treatment period .
-RESULTS	Clopidogrel therapy resulted in a significant reduction in soluble CD40 ligand ( P = 0.03 ) , a prothrombotic and proinflammatory molecule derived mainly from activated platelets .
-RESULTS	However , clopidogrel therapy had no effect on endothelial function , arterial stiffness , inflammatory and oxidative stress markers , or progenitor cells .
-CONCLUSIONS	Our findings suggest a solitary antiplatelet effect of clopidogrel therapy in patients with stable coronary artery disease , with no effect on other subclinical markers of cardiovascular disease risk .
-
-###24403557
-BACKGROUND	Clade B DNA and recombinant modified vaccinia Ankara ( MVA ) vaccines producing virus-like particles displaying trimeric membrane-bound envelope glycoprotein ( Env ) were tested in a phase 2a trial in human immunodeficiency virus ( HIV ) - uninfected adults for safety , immunogenicity , and 6-month durability of immune responses .
-METHODS	A total of 299 individuals received 2 doses of JS7 DNA vaccine and 2 doses of MVA/HIV62B at 0 , 2 , 4 , and 6 months , respectively ( the DDMM regimen ) ; 3 doses of MVA/HIV62B at 0 , 2 , and 6 months ( the MMM regimen ) ; or placebo injections .
-RESULTS	At peak response , 93.2 % of the DDMM group and 98.4 % of the MMM group had binding antibodies for Env .
-RESULTS	These binding antibodies were more frequent and of higher magnitude for the transmembrane subunit ( gp41 ) than the receptor-binding subunit ( gp120 ) of Env .
-RESULTS	For both regimens , response rates were higher for CD4 ( + ) T cells ( 66.4 % in the DDMM group and 43.1 % in the MMM group ) than for CD8 ( + ) T cells ( 21.8 % in the DDMM group and 14.9 % in the MMM group ) .
-RESULTS	Responding CD4 ( + ) and CD8 ( + ) T cells were biased toward Gag , and > 70 % produced 2 or 3 of the 4 cytokines evaluated ( ie , interferon , interleukin 2 , tumor necrosis factor , and granzyme B ) .
-RESULTS	Six months after vaccination , the magnitudes of antibodies and T-cell responses had decreased by < 3-fold .
-CONCLUSIONS	DDMM and MMM vaccinations with virus-like particle-expressing immunogens elicited durable antibody and T-cell responses .
-
-###25270273
-OBJECTIVE	AR-13324 is a small-molecule inhibitor of Rho kinase and a norepinephrine transporter .
-OBJECTIVE	The objective of this 28-day study was to evaluate the ocular hypotensive efficacy and safety of AR-13324 ophthalmic solution compared with a positive control , latanoprost ophthalmic solution , in patients with open-angle glaucoma ( OAG ) or ocular hypertension ( OHT ) .
-METHODS	Double-masked , randomized study in 22 private practice ophthalmology clinics .
-METHODS	Participants were required to be adults with a diagnosis of OAG or OHT with unmedicated intraocular pressure ( IOP ) in the range of 22 to 36 mmHg .
-METHODS	Patients were randomized to receive AR-13324 ophthalmic solution 0.01 % , daily ( pm ) , AR-13324 ophthalmic solution 0.02 % daily ( pm ) , or latanoprost 0.005 % daily ( pm ) for 28 days .
-METHODS	The primary efficacy endpoint was the mean diurnal IOP across subjects within the treatment group at day 28 .
-RESULTS	Randomized and treated were 224 patients , 213 ( 95.1 % ) of whom completed the study .
-RESULTS	On day 28 , mean diurnal IOP was 20.1 , 20.0 , and 18.7 mmHg in the AR-13324 0.01 % , 0.02 % , and latanoprost groups , respectively , representing a decrease from unmedicated baseline of 5.5 , 5.7 , and 6.8 mmHg ( P < 0.001 ) .
-RESULTS	The 5.7-mmHg reduction in IOP by AR-13324 0.02 % did not meet the criterion for noninferiority to latanoprost .
-RESULTS	The most frequently reported adverse event was conjunctival/ocular hyperemia , with a combined incidence of 52 % , 57 % , and 16 % , respectively .
-RESULTS	On day 28 at 08:00 hours , the incidence of mild to moderate hyperemia by biomicroscopy was 18 % , 24 % , and 11 % , respectively .
-CONCLUSIONS	AR-13324 0.02 % was less effective than latanoprost by approximately 1 mmHg in patients with unmedicated IOPs of 22 to 35 mmHg .
-CONCLUSIONS	The major safety finding was ocular hyperemia , which was more common for both concentrations of AR-13324 than for latanoprost .
-
-###25456420
-BACKGROUND	Gamisoyo-San ( GSS ) is a well-known Traditional Korean Medicine shown to be effective on mood disorders .
-OBJECTIVE	The purpose of this research is to examine the effect of Gamisoyo-San on generalized anxiety disorder by its differently manufactured preparations .
-METHODS	Multicenter , randomized , double-blinded , placebo-controlled study was set for 147 patients with generalized anxiety disorder recruited from November 1st 2009 to December 16th 2010 .
-METHODS	They were given Gamisoyo-San individual extract mixture ( extraction done for each crude materia medica separately ) or Gamisoyo-San multi-compound extract ( extraction done for whole materia medica at once ) or controlled medication .
-METHODS	Hamilton Rating Scale for Anxiety ( HAM-A ) , Korean State-Trait Anxiety Inventory ( K-STAI ) , Penn State Worry Questionnaire ( PSWQ ) , Korean Beck Depression Inventroy ( K-BDI ) , Symptom Checklist-90-Revised ( SCL-90-R ) , and Korean WHO Quality of Life Scale Abbreviated Version ( WHOQOL-BREF ) were evaluated .
-METHODS	We also applied Pattern Identification tool for ` JingJi and ZhengChong ( , Traditional Korean Medicine term which correlates with generalized anxiety disorder ) ' to patients to evaluate different responses among 9 patterns .
-RESULTS	HAM-A scores of Gamisoyo-San multi-compound extract group showed greater decrease compared to Gamisoyo-San individual extract mixture group and placebo group , but the difference was insignificant .
-RESULTS	WHOQOL-BREF scores of Gamisoyo-San multi-compound extract group showed significant increase compared to Gamisoyo-San individual extract mixture group and placebo group .
-RESULTS	In Heart blood deficiency pattern , the Gamisoyo-San multi-compound extract group showed significant decrease in K-BDI compared to the Gamisoyo-San individual extract mixture group .
-CONCLUSIONS	Gamisoyo-San did not improve anxiety level of GAD patients .
-CONCLUSIONS	However , it can be useful to improve quality of life , and reduce depressive , obsessive-compulsive , somatic symptoms of generalized anxiety disorder .
-CONCLUSIONS	Gamisoyo-San multi-compound seemed more effective than Gamisoyo-San individual extract mixture , especially in Heart blood deficiency pattern .
-
-###25108751
-OBJECTIVE	The purpose of this pilot clinical trial was to assess the feasibility of recruiting older adults with lumbar spinal stenosis ( LSS ) into a clinical trial that used different dosages of flexion-distraction manipulation .
-METHODS	This randomized controlled trial used a 4-group design .
-METHODS	Three groups consisted of chiropractic flexion-distraction manipulation applied at different dosages ( 8 , 12 , or 18 treatments ) .
-METHODS	The fourth group was given 8 treatments of placebo care .
-METHODS	Feasibility measures included recruitment goals , adherence to various treatment schedules , credibility of the placebo treatment , and rates of adverse events .
-METHODS	The primary outcome measure was the Swiss Spinal Stenosis Questionnaire , a validated self-report of LSS symptom severity and physical function .
-RESULTS	The recruitment and adherence goals of the study were met with a total of 60 subjects randomized ( n = 15 per group ) and most subjects attending at least 75 % of their scheduled visits .
-RESULTS	No adverse events were reported by any of the subjects in the trial .
-RESULTS	Our placebo treatment did not appear to be credible ; most subjects correctly guessed that they were receiving a placebo treatment .
-RESULTS	Between-group effect size estimates were small , indicating larger samples are needed for future studies .
-CONCLUSIONS	This pilot study showed that it is feasible to recruit patients with LSS and that most subjects will adhere to a 6-week treatment schedule .
-CONCLUSIONS	The information gained from this trial will be useful to inform the design of larger trials .
-
-###24503451
-BACKGROUND	It is often assumed that animations ( i.e. , videos ) will lead to higher learning compared to static media ( i.e. , pictures ) because they provide a more realistic demonstration of the learning task .
-OBJECTIVE	To investigate whether learning basic life support ( BLS ) and cardiopulmonary resuscitation ( CPR ) from video produce higher learning outcomes compared to pictures in reciprocal learning .
-METHODS	A randomized controlled trial .
-METHODS	A total of 128 students ( mean age : 17 years ) constituting eight intact classes from a secondary school learned BLS in reciprocal roles of doer and helper with tablet PCs .
-METHODS	Student pairs in each class were randomized over a Picture and a Video group .
-METHODS	In the Picture group , students learned BLS by means of pictures combined with written instructions .
-METHODS	In the Video group , BLS was learned through videos with on-screen instructions .
-METHODS	Informational equivalence was assured since instructions in both groups comprised exactly the same words .
-METHODS	BLS assessment occurred unannounced , three weeks following intervention .
-RESULTS	Analysis of variance demonstrated no significant differences in chest compression depths between the Picture group ( M = 42 mm , 95 % CI = 40-45 ) and the Video group ( M = 39 mm , 95 % CI = 36-42 ) .
-RESULTS	In the Picture group significantly higher percentages of chest compressions with correct hand placement were achieved ( M = 67 % , CI = 58-77 ) compared to the Video group ( M = 53 % , CI = 43-63 ) , P = .03 , ( p ) ( 2 ) = .03 .
-RESULTS	No other significant differences were found .
-CONCLUSIONS	Results do not support the assumption that videos are superior to pictures for learning BLS and CPR in reciprocal learning .
-
-###25216572
-OBJECTIVE	Target volumes and organs-at-risk ( OARs ) for radiotherapy ( RT ) planning are manually defined , which is a tedious and inaccurate process .
-OBJECTIVE	We sought to assess the feasibility , time reduction , and acceptability of an atlas-based autosegmentation ( AS ) compared to manual segmentation ( MS ) of OARs .
-METHODS	A commercial platform generated 16 OARs .
-METHODS	Resident physicians were randomly assigned to modify AS OAR ( AS+R ) or to draw MS OAR followed by attending physician correction .
-METHODS	Dice similarity coefficient ( DSC ) was used to measure overlap between groups compared with attending approved OARs ( DSC = 1 means perfect overlap ) .
-METHODS	40 cases were segmented .
-RESULTS	Mean SD segmentation time in the AS+R group was 19.7 8.0 min , compared to 28.5 8.0 min in the MS cohort , amounting to a 30.9 % time reduction ( Wilcoxon p < 0.01 ) .
-RESULTS	For each OAR , AS DSC was statistically different from both AS+R and MS ROIs ( all Steel-Dwass p < 0.01 ) except the spinal cord and the mandible , suggesting oversight of AS/MS processes is required ; AS+R and MS DSCs were non-different .
-RESULTS	AS compared to attending approved OAR DSCs varied considerably , with a chiasm mean SD DSC of 0.37 0.32 and brainstem of 0.97 0.03 .
-CONCLUSIONS	Autosegmentation provides a time savings in head and neck regions of interest generation .
-CONCLUSIONS	However , attending physician approval remains vital .
-
-###25068456
-OBJECTIVE	Weight discrimination is associated with increased risk of obesity .
-OBJECTIVE	The mechanism of this relationship is unknown , but being overweight is a highly stigmatized condition and may be a source of chronic stress that contributes to the development and pathophysiology of obesity .
-OBJECTIVE	The objective of this study was to test whether weight stigma is associated with physiological risk factors linked to stress and obesity , including hypercortisolism and oxidative stress , independent of adiposity .
-METHODS	We examined the frequency of experiencing situations involving weight stigma and consciousness of weight stigma in relation to hypothalamic -- pituitary -- adrenal axis activity and oxidative stress ( F-isoprostanes ) in 45 healthy overweight to obese women .
-RESULTS	Independent of abdominal fat , weight stigma was significantly related to measures of cortisol ( including salivary measures of cortisol awakening response and serum morning levels ) as well as higher levels of oxidative stress .
-RESULTS	Perceived stress mediated the relationship between weight stigma consciousness and the cortisol awakening response .
-CONCLUSIONS	These preliminary findings show that weight stigma is associated with greater biochemical stress , independent of level of adiposity .
-CONCLUSIONS	It is possible that weight stigma may contribute to poor health underlying some forms of obesity .
-
-###25428337
-OBJECTIVE	To determine the impact of adjunctive Buchang Naoxintong Capsule ( , NXT ) on dual antiplatelet therapy in patients with cytochrome P450 2C19 * 2 ( CYP2C19 * 2 ) polymorphism undergoing percutaneous coronary intervention ( PCI ) .
-METHODS	Ninety patients with CYP2C19 * 2 polymorphism were enrolled , and their genotypes were confirmed by polymerase chain reaction ( PCR ) .
-METHODS	The patients were randomly assigned to receive either adjunctive NXT ( triple group , 45 cases ) or dual antiplatelet therapy ( dual group , 45 cases ) using a computer-generated randomization sequence and sealed envelopes .
-METHODS	Platelet function was assessed at baseline and 7 days after treatment with conventional aggregometry .
-METHODS	Subsequent major adverse cardiovascular events ( MACE , including sudden cardiac arrest and acute coronary syndrome ) were recorded during a 12-month follow-up .
-RESULTS	Baseline platelet function measurements were similar in both groups .
-RESULTS	After 7 days , percent inhibitions of maximum platelet aggregation and late platelet aggregation were significantly greater in the triple versus dual group ( 42.3 % 16.0 % vs. 20.8 % 15.2 % , P < 0.01 , and 54.7 % 18.3 % vs. 21.5 % 29.2 % , P < 0.01 , respectively ) .
-RESULTS	During the 12-month follow-up , the rate of subsequent MACE ( 6/45 ) was significantly lower in the triple group compared with the dual group ( 14/45 ; P < 0.05 ) .
-CONCLUSIONS	Adjunctive NXT to maintenance dose clopidogrel ( 75 g ) could enhance the antiplatelet effect and decrease subsequent MACE in patients with the CYP2C19 * 2 polymorphism undergoing PCI .
-
-###24238862
-OBJECTIVE	To investigate the safety , efficacy , and pharmacokinetic profile of dexmedetomidine in preterm and full-term neonates 28 to 44 weeks gestational age .
-METHODS	Forty-two intubated , mechanically ventilated patients ( n = 42 ) were grouped by gestational age into group I ( n = 18 ) , 28 to < 36 weeks , and group II ( n = 24 ) , 36 to 44 weeks .
-METHODS	Within each age group , there were 3 escalating dose levels , including a loading dose ( LD , g/kg ) followed by a maintenance dose ( MD , g kg ( -1 ) h ( -1 ) ) for 6-24 hours : level 1 , 0.05 LD/MD ; level 2 , 0.1 LD/MD ; and level 3 , 0.2 LD/MD .
-METHODS	The primary endpoint was the number of patients requiring sedation as determined by the Neonatal Pain , Agitation , Sedation Scale .
-RESULTS	During dexmedetomidine infusion , 5 % of Neonatal Pain , Agitation , Sedation Scale scores were > 3 , indicating agitation/pain , with 4 patients ( 10 % ) requiring more sedation and 17 ( 40 % ) requiring more analgesia .
-RESULTS	Though there was significant variability in pharmacokinetic variables , group I appeared to have lower weight-adjusted plasma clearance ( 0.3 vs 0.9 L h ( -1 ) kg ( -1 ) ) and increased elimination half-life ( 7.6 vs 3.2 hours ) compared with group II .
-RESULTS	Fifty-six adverse events ( AEs ) were reported in 26 patients ( 62 % ) ; only 3 AEs ( 5 % ) were related to dexmedetomidine .
-RESULTS	There were no serious AEs and no AEs or hemodynamic changes requiring dexmedetomidine discontinuation .
-CONCLUSIONS	Dexmedetomidine is effective for sedating preterm and full-term neonates and is well-tolerated without significant AEs .
-CONCLUSIONS	Preterm neonates had decreased plasma clearance and longer elimination half-life .
-
-###25155070
-OBJECTIVE	Behavioral change interventions have demonstrated short-term efficacy in reducing sexually transmitted infection ( STI ) / human immunodeficiency virus ( HIV ) risk behaviors ; however , few have demonstrated long-term efficacy .
-OBJECTIVE	To evaluate the efficacy of a telephone counseling prevention maintenance intervention ( PMI ) to sustain STI/HIV-preventive behaviors and reduce incident STIs during a 36-month follow-up .
-METHODS	In a 2-arm randomized supplemental treatment trial at 3 clinics serving predominantly minority adolescents in Atlanta , Georgia , 701 African American adolescent girls aged 14 to 20 years received a primary treatment and subsequently received a different ( supplemental ) treatment ( PMI ) to enhance effects of the primary treatment .
-METHODS	Participants in the experimental condition ( n = 342 ) received an adapted evidence-based STI/HIV intervention ( HORIZONS ) and a PMI consisting of brief telephone contacts every 8 weeks over 36 months to reinforce and complement prevention messages .
-METHODS	Comparison-condition participants ( n = 359 ) received HORIZONS and a time - and dose-consistent PMI focused on general health .
-METHODS	The primary outcomes were percentage of participants with a laboratory-confirmed incident chlamydial infection and percentage of participants with a laboratory-confirmed gonococcal infection during the 36-month follow-up .
-METHODS	Behavioral outcomes included the following : ( 1 ) proportion of condom-protected sexual acts in the 6 months and 90 days prior to assessments ; ( 2 ) number of sexual episodes during the past 90 days in which participants engaged in sexual intercourse while high on drugs and/or alcohol ; and ( 3 ) number of vaginal sex partners in the 6 months prior to assessments .
-RESULTS	During the 36-month follow-up , fewer participants in the experimental condition than in the comparison condition had incident chlamydial infections ( 94 vs 104 participants , respectively ; risk ratio = 0.50 ; 95 % CI , 0.28 to 0.88 ; P = .02 ) and gonococcal infections ( 48 vs 54 participants , respectively ; risk ratio = 0.40 ; 95 % CI , 0.15 to 1.02 ; P = .06 ) .
-RESULTS	Participants completing more telephone contacts had a lower risk of chlamydial infection ( risk ratio = 0.95 ; 95 % CI , 0.90 to 1.00 ; P = .05 ) .
-RESULTS	Participants in the experimental condition reported a higher proportion of condom-protected sexual acts in the 90 days ( mean difference = 0.08 ; 95 % CI , 0.06 to 0.11 ; P = .02 ) and 6 months ( mean difference = 0.08 ; 95 % CI , 0.06 to 0.10 ; P = .04 ) prior to assessments and fewer episodes of sexual acts while high on drugs and/or alcohol ( mean difference = -0.61 ; 95 % CI , -0.98 to -0.24 ; P < .001 ) .
-CONCLUSIONS	Sustaining the long-term impact of an STI/HIV intervention is achievable with brief , tailored telephone counseling .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00279799 .
-
-###25535800
-OBJECTIVE	The first description of the simplified acute physiology score ( SAPS ) II dates back to 1993 , but little is known about its accuracy in daily practice .
-OBJECTIVE	Our purpose was to evaluate the accuracy of scoring and the factors that affect it in a nationwide survey .
-METHODS	Twenty clinical scenarios , covering a broad range of illness severities , were randomly assigned to a convenience sample of physicians or nurses in Swiss adult intensive care units ( ICUs ) , who were asked to assess the SAPS II score for a single scenario .
-METHODS	These data were compared to a reference that was defined by five experienced researchers .
-METHODS	The results were cross-matched with demographic characteristics and data on the training and quality control for the scoring , structural and organisational properties of each participating ICU .
-RESULTS	A total of 345 caregivers from 53 adult ICU providers completed the SAPS II evaluation of one clinical scenario .
-RESULTS	The mean SAPS II scoring was 42.6 23.4 , with a bias of +5.74 ( 95 % CI 2.0-9 .5 ) compared to the reference score .
-RESULTS	There was no evidence of bias variation according to the case severity , ICU size , linguistic area , profession ( physician vs. nurse ) , experience , initial SAPS II training , or presence of a quality control system .
-CONCLUSIONS	This nationwide survey revealed substantial variability in the SAPS II scoring results .
-CONCLUSIONS	On average , SAPS II scoring was overestimated by more than 13 % , irrespective of the profession or experience of the scorer or of the structural characteristics of the ICUs .
-
-###24529081
-BACKGROUND	Stereoscopic vision is a critical part of the human visual system , conveying more information than two-dimensional , monoscopic observation alone .
-BACKGROUND	This study aimed to quantify the contribution of stereoscopy in assessment of radiographic data , using widely available three-dimensional ( 3D ) - capable display monitors by assessing whether stereoscopic viewing improved the characterisation of cerebral aneurysms .
-METHODS	Nine radiology registrars were shown 40 different volume-rendered ( VR ) models of cerebral computed tomography angiograms ( CTAs ) , each in both monoscopic and stereoscopic format and then asked to record aneurysm characteristics on short multiple-choice answer sheets .
-METHODS	The monitor used was a current model commercially available 3D television .
-METHODS	Responses were marked against a gold standard of assessments made by a consultant radiologist , using the original CT planar images on a diagnostic radiology computer workstation .
-RESULTS	The participants ' results were fairly homogenous , with most showing no difference in diagnosis using stereoscopic VR models .
-RESULTS	One participant performed better on the monoscopic VR models .
-RESULTS	On average , monoscopic VRs achieved a slightly better diagnosis by 2.0 % .
-CONCLUSIONS	Stereoscopy has a long history , but it has only recently become technically feasible for stored cross-sectional data to be adequately reformatted and displayed in this format .
-CONCLUSIONS	Scant literature exists to quantify the technology 's possible contribution to medical imaging - this study attempts to build on this limited knowledge base and promote discussion within the field .
-CONCLUSIONS	Stereoscopic viewing of images should be further investigated and may well eventually find a permanent place in procedural and diagnostic medical imaging .
-
-###24978857
-BACKGROUND	Vaccines against pandemic A/H1N1 influenza should provide protective immunity in children , because they are at greater risk of disease than adults .
-BACKGROUND	This study was conducted to identify the optimal dose of an MF59-adjuvanted , egg-derived , A/H1N1 influenza vaccine for young children .
-METHODS	Children 6-11 months ( N = 144 ) and 12-35 months ( N = 186 ) of age received vaccine formulations containing either 3.75 g antigen with half the standard dose of MF59 or 7.5 g antigen with a standard dose of MF59 , or a nonadjuvanted formulation containing 15 g antigen ( children 12-35 months only ) .
-METHODS	Participants were given 2 primary vaccine doses 3 weeks apart , followed by 1 booster dose of MF59-adjuvanted seasonal influenza vaccine 1 year later .
-METHODS	Immunogenicity was assessed by hemagglutination inhibition and microneutralization assays .
-RESULTS	All vaccine formulations were highly immunogenic and met all 3 European licensure criteria after 2 doses .
-RESULTS	MF59-adjuvanted vaccines met all licensure criteria after 1 dose in both age cohorts , while nonadjuvanted vaccine did not meet all criteria after 1 dose in children 12-35 months .
-RESULTS	A single booster dose was highly immunogenic , and stable antibody persistence was observed in response to all vaccines .
-RESULTS	All vaccines were well tolerated .
-CONCLUSIONS	In this study , a single dose of 3.75 g antigen with half the standard dose of MF59 was shown to be optimal , providing adequate levels of immediate and long-term antibodies in pediatric subjects 6-35 months of age .
-CONCLUSIONS	These data demonstrated that MF59 adjuvant allowed for reduced antigen content and promoted significant long-term antibody persistence in children , with a satisfactory safety profile .
-
-###25448245
-OBJECTIVE	First , to evaluate the clinical effectiveness of a virtual reality ( VR ) - based telerehabilitation program in the balance recovery of individuals with hemiparesis after stroke in comparison with an in-clinic program ; second , to compare the subjective experiences ; and third , to contrast the costs of both programs .
-METHODS	Single-blind , randomized , controlled trial .
-METHODS	Neurorehabilitation unit .
-METHODS	Chronic outpatients with stroke ( N = 30 ) with residual hemiparesis .
-METHODS	Twenty 45-minute training sessions with the telerehabilitation system , conducted 3 times a week , in the clinic or in the home .
-METHODS	First , Berg Balance Scale for balance assessment .
-METHODS	The Performance-Oriented Mobility Assessment balance and gait subscales , and the Brunel Balance Assessment were secondary outcome measures .
-METHODS	Clinical assessments were conducted at baseline , 8 weeks ( posttreatment ) , and 12 weeks ( follow-up ) .
-METHODS	Second , the System Usability Scale and the Intrinsic Motivation Inventory for subjective experiences .
-METHODS	Third , cost ( in dollars ) .
-RESULTS	Significant improvement in both groups ( in-clinic group [ control ] and a home-based telerehabilitation group ) from the initial to the final assessment in the Berg Balance Scale ( p ( 2 ) = .68 ; P = .001 ) , in the balance ( p ( 2 ) = .24 ; P = .006 ) and gait ( p ( 2 ) = .57 , P = .001 ) subscales of the Tinetti Performance-Oriented Mobility Assessment , and in the Brunel Balance Assessment ( control : ( 2 ) = 15.0 ; P = .002 ; experimental : ( 2 ) = 21.9 ; P = .001 ) .
-RESULTS	No significant differences were found between the groups in any balance scale or in the feedback questionnaires .
-RESULTS	With regard to subjective experiences , both groups considered the VR system similarly usable and motivating .
-RESULTS	The in-clinic intervention resulted in more expenses than did the telerehabilitation intervention ( $ 654.72 per person ) .
-CONCLUSIONS	First , VR-based telerehabilitation interventions can promote the reacquisition of locomotor skills associated with balance in the same way as do in-clinic interventions , both complemented with a conventional therapy program ; second , the usability of and motivation to use the 2 interventions can be similar ; and third , telerehabilitation interventions can involve savings that vary depending on each scenario .
-
-###25956718
-BACKGROUND	Transfusion thresholds for acute upper gastrointestinal bleeding are controversial .
-BACKGROUND	So far , only three small , underpowered studies and one single-centre trial have been done .
-BACKGROUND	Findings from the single-centre trial showed reduced mortality with restrictive red blood cell ( RBC ) transfusion .
-BACKGROUND	We aimed to assess whether a multicentre , cluster randomised trial is a feasible method to substantiate or refute this finding .
-METHODS	In this pragmatic , open-label , cluster randomised feasibility trial , done in six university hospitals in the UK , we enrolled all patients aged 18 years or older with new presentations of acute upper gastrointestinal bleeding , irrespective of comorbidity , except for exsanguinating haemorrhage .
-METHODS	We randomly assigned hospitals ( 1:1 ) with a computer-generated randomisation sequence ( random permuted block size of 6 , without stratification or matching ) to either a restrictive ( transfusion when haemoglobin concentration fell below 80 g/L ) or liberal ( transfusion when haemoglobin concentration fell below 100 g/L ) RBC transfusion policy .
-METHODS	Neither patients nor investigators were masked to treatment allocation .
-METHODS	Feasibility outcomes were recruitment rate , protocol adherence , haemoglobin concentration , RBC exposure , selection bias , and information to guide design and economic evaluation of the phase 3 trial .
-METHODS	Main exploratory clinical outcomes were further bleeding and mortality at day 28 .
-METHODS	We did analyses on all enrolled patients for whom an outcome was available .
-METHODS	This trial is registered , ISRCTN85757829 and NCT02105532 .
-RESULTS	Between Sept 3 , 2012 , and March 1 , 2013 , we enrolled 936 patients across six hospitals ( 403 patients in three hospitals with a restrictive policy and 533 patients in three hospitals with a liberal policy ) .
-RESULTS	Recruitment rate was significantly higher for the liberal than for the restrictive policy ( 62 % vs 55 % ; p = 004 ) .
-RESULTS	Despite some baseline imbalances , Rockall and Blatchford risk scores were identical between policies .
-RESULTS	Protocol adherence was 96 % ( SD 10 ) in the restrictive policy vs 83 % ( 25 ) in the liberal policy ( difference 14 % ; 95 % CI 7-21 ; p = 0005 ) .
-RESULTS	Mean last recorded haemoglobin concentration was 116 ( SD 24 ) g/L for patients on the restrictive policy and 118 ( 20 ) g/L for those on the liberal policy ( difference -20 [ 95 % CI -120 to 70 ] ; p = 050 ) .
-RESULTS	Fewer patients received RBCs on the restrictive policy than on the liberal policy ( restrictive policy 133 [ 33 % ] vs liberal policy 247 [ 46 % ] ; difference -12 % [ 95 % CI -35 to 11 ] ; p = 023 ) , with fewer RBC units transfused ( mean 12 [ SD 21 ] vs 19 [ 28 ] ; difference -07 [ -16 to 03 ] ; p = 012 ) , although these differences were not significant .
-RESULTS	We noted no significant difference in clinical outcomes .
-CONCLUSIONS	A cluster randomised design led to rapid recruitment , high protocol adherence , separation in degree of anaemia between groups , and non-significant reduction in RBC transfusion in the restrictive policy .
-CONCLUSIONS	A large cluster randomised trial to assess the effectiveness of transfusion strategies for acute upper gastrointestinal bleeding is both feasible and essential before clinical practice guidelines change to recommend restrictive transfusion for all patients with acute upper gastrointestinal bleeding .
-BACKGROUND	NHS Blood and Transplant Research and Development .
-
-###24626068
-BACKGROUND	Workplace stress and burnout are pervasive problems , affecting employee performance and personal health .
-OBJECTIVE	To evaluate the effects of the Transcendental Meditation program on psychological distress and burnout among staff at a residential therapeutic school for students with severe behavioral problems .
-METHODS	A total of 40 secondary schoolteachers and support staff at the Bennington School in Vermont , a therapeutic school for children with behavioral problems , were randomly assigned to either practice of the Transcendental Meditation program or a wait-list control group .
-METHODS	The Transcendental Meditation course was provided by certified instructors .
-METHODS	Outcome measures were assessed at baseline and four months , and included perceived stress , depression , and burnout .
-METHODS	A multivariate analysis of covariance was used to determine overall effects .
-RESULTS	Analysis of the 4-month intervention data indicated a significant improvement in the main outcomes of the study resulting from practice of the Transcendental Meditation program compared with controls ( Wilks [ 3,28 ] = 0.695 ; p = 0.019 ) .
-RESULTS	Results of univariate F tests indicated a significant reduction of all main outcome measures : perceived stress ( F [ 1,32 ] = 13.42 ; p = < 0.001 ) ; depression ( F [ 1,32 ] = 6.92 ; p = 0.013 ) ; and overall teacher burnout ( F [ 1,32 ] = 6.18 ; p = 0.018 ) .
-RESULTS	Effect sizes ranged from 0.40 to 0.94 .
-CONCLUSIONS	The Transcendental Meditation program was effective in reducing psychological distress in teachers and support staff working in a therapeutic school for students with behavioral problems .
-CONCLUSIONS	These findings have important implications for employees job performance as well as their mental and physical health .
-
-###25153911
-OBJECTIVE	To perform a prospective , blinded , randomized interventional trial in patients with recurrent abdominal pain .
-OBJECTIVE	The primary endpoint was to determine the abdominal pain intensity after 2 weeks of fructose restricted diet .
-OBJECTIVE	Secondary endpoints were changes of pain frequency and a secondary symptom score ( SSS ) .
-METHODS	103 individuals with recurrent abdominal pain for more than 3 months were randomized .
-METHODS	51 patients were allocated to group A ( diet ) and 52 to group B ( no diet ) .
-METHODS	2 weeks later the patients underwent hydrogen breath test and were assigned to the test positive or negative group to identify patients with fructose malabsorption .
-RESULTS	2 weeks after intervention the pain score decreased significantly from a median 5.5 in group A to 4 and did not change significantly in group B ( 5.3 to 5 ) .
-RESULTS	In group A both patients with positive and negative breath tests had a significant lower pain score ( -2 and -1.75 , respectively ) .
-RESULTS	Frequency of abdominal pain decreased in both groups but without significant difference , SSS improved only in group A from median 6 to 3.5 .
-RESULTS	Positive breath test was no predicting factor , neither was abdominal pain during the test .
-CONCLUSIONS	Fructose restricted diet in children and adolescents with recurrent abdominal pain may be of benefit to improve both abdominal pain symptoms and other secondary symptoms .
-CONCLUSIONS	Since a negative breath test result does not exclude a positive response to fructose restriction , the hydrogen breath test does not seem to be the appropriate diagnostic mean to predict the response to the diet .
-
-###24433412
-BACKGROUND	The objective of the current study was to examine predictors and moderators of response to two HIV sexual risk interventions of different content and duration for individuals in substance abuse treatment programs .
-METHODS	Participants were recruited from community drug treatment programs participating in the National Institute on Drug Abuse Clinical Trials Network ( CTN ) .
-METHODS	Data were pooled from two parallel randomized controlled CTN studies ( one with men and one with women ) each examining the impact of a multi-session motivational and skills training program , in comparison to a single-session HIV education intervention , on the degree of reduction in unprotected sex from baseline to 3 - and 6 - month follow-ups .
-METHODS	The findings were analyzed using a zero-inflated negative binomial ( ZINB ) model .
-RESULTS	Severity of drug use ( p < .01 ) , gender ( p < .001 ) , and age ( p < .001 ) were significant main effect predictors of number of unprotected sexual occasions ( USOs ) at follow-up in the non-zero portion of the ZINB model ( men , younger participants , and those with greater severity of drug/alcohol abuse have more USOs ) .
-RESULTS	Monogamous relationship status ( p < .001 ) and race/ethnicity ( p < .001 ) were significant predictors of having at least one USO vs. none ( monogamous individuals and African Americans were more likely to have at least one USO ) .
-RESULTS	Significant moderators of intervention effectiveness included recent sex under the influence of drugs/alcohol ( p < .01 in non-zero portion of model ) , duration of abuse of primary drug ( p < .05 in non-zero portion of model ) , and Hispanic ethnicity ( p < .01 in the zero portion , p < .05 in the non-zero portion of model ) .
-CONCLUSIONS	These predictor and moderator findings point to ways in which patients may be selected for the different HIV sexual risk reduction interventions and suggest potential avenues for further development of the interventions for increasing their effectiveness within certain subgroups .
-
-###24388483
-BACKGROUND	The effect of eating speed on energy intake by weight status is unclear .
-OBJECTIVE	To examine whether the effect of eating speed on energy intake is the same in normal-weight and overweight/obese subjects .
-METHODS	The effect of slow and fast eating speed on meal energy intake was assessed in a randomized crossover design .
-METHODS	Thirty-five normal-weight ( aged 33.312.5 years ; 14 women and 21 men ) subjects and 35 overweight/obese ( 44.113.0 years ; 22 women and 13 men ) subjects were studied on 2 days during lunch in a metabolic kitchen .
-METHODS	The subjects consumed the same meal , ad libitum , but at different speeds during the two eating conditions .
-METHODS	The weight and energy content of the food consumed was assessed .
-METHODS	Perceived hunger and fullness were assessed at specific times using visual analog scales .
-METHODS	Effect of eating speed on ad libitum energy intake , eating rate ( energy intake/meal duration ) , energy density ( energy intake per gram of food and water consumed ) , and satiety were assessed by mixed-model repeated measures analysis .
-RESULTS	Meal energy intake was significantly lower in the normal-weight ( 804.5438.9 vs 892.6330.2 kcal ; P = 0.04 ) but not the overweight/obese ( 667.3304.1 vs 724.8355.5 kcal ; P = 0.18 ) subjects during the slow vs the fast eating condition .
-RESULTS	Both groups had lower meal energy density ( P = 0.005 and P = 0.001 , respectively ) and eating rate ( P < 0.0001 in both groups ) during the slow vs the fast eating condition .
-RESULTS	Both groups reported less hunger ( P = 0.01 and P = 0.03 , respectively ) , and the normal-weight subjects reported more fullness ( P = 0.02 ) at 60 minutes after the meal began during the slow compared with the fast eating condition .
-RESULTS	There was no eating speed by weight status interaction for any of the variables .
-CONCLUSIONS	Eating slowly significantly lowered meal energy intake in the normal-weight but not in the overweight/obese group .
-CONCLUSIONS	It lowered eating rate and energy density in both groups .
-CONCLUSIONS	Eating slowly led to lower hunger ratings in both groups and increased fullness ratings in the normal-weight group at 60 minutes from when the meal began .
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-###25886927
-BACKGROUND	Real-time adherence monitoring is now possible through medication storage devices equipped with cellular technology .
-BACKGROUND	We assessed the effect of triggered cell phone reminders and counseling using objective adherence data on antiretroviral therapy ( ART ) adherence among Chinese HIV-infected patients .
-METHODS	We provided ART patients in Nanning , China , with a medication device ( Wisepill ) to monitor their ART adherence electronically .
-METHODS	After 3 months , we randomized subjects within optimal ( 95 % ) and suboptimal ( < 95 % ) adherence strata to intervention vs. control arms .
-METHODS	In months 4-9 , intervention subjects received individualized reminders triggered by late dose taking ( no device opening by 30 minutes past dose time ) and counseling using device-generated data .
-METHODS	Controls received no reminders or data-informed counseling .
-METHODS	We compared postintervention proportions achieving optimal adherence , mean adherence , and clinical outcomes .
-RESULTS	Of 120 subjects enrolled , 116 ( 96.7 % ) completed the trial .
-RESULTS	Preintervention optimal adherence was similar in intervention vs. control arms ( 63.5 % vs. 58.9 % , respectively ; P = 0.60 ) .
-RESULTS	In the last intervention month , 87.3 % vs. 51.8 % achieved optimal adherence [ risk ratio ( RR ) : 1.7 , 95 % confidence interval ( CI ) : 1.3 to 2.2 ] and mean adherence was 96.2 % vs. 89.1 % ( P = 0.003 ) .
-RESULTS	Among preintervention suboptimal adherers , 78.3 % vs. 33.3 % ( RR : 2.4 , CI : 1.2 to 4.5 ) achieved optimal adherence and mean adherence was 93.3 % vs. 84.7 % ( P = 0.039 ) .
-RESULTS	Proportions were 92.5 % and 62.9 % among optimal adherers , respectively ( RR : 1.5 , CI : 1.1 to 1.9 ) and mean adherence was 97.8 % vs. 91.7 % ( P = 0.028 ) .
-RESULTS	Postintervention clinical outcomes were not significant .
-CONCLUSIONS	Real-time reminders significantly improved ART adherence in this population .
-CONCLUSIONS	This approach seems promising for managing HIV and other chronic diseases and warrants further investigation and adaptation in other settings .
-
-###24436351
-BACKGROUND	There is interest in including recommendations for the replacement of the sodium lost in sweat in individualized hydration plans for athletes .
-OBJECTIVE	Although the regional absorbent-patch method provides a practical approach to measuring sweat sodium losses in field conditions , there is a need to understand the variability of estimates associated with this technique .
-METHODS	Sweat samples were collected from the forearms , chest , scapula , and thigh of 12 cyclists during 2 standardized cycling time trials in the heat and 2 in temperate conditions .
-METHODS	Single measure analysis of sodium concentration was conducted immediately by ion-selective electrodes ( ISE ) .
-METHODS	A subset of 30 samples was frozen for reanalysis of sodium concentration using ISE , flame photometry ( FP ) , and conductivity ( SC ) .
-RESULTS	Sweat samples collected in hot conditions produced higher sweat sodium concentrations than those from the temperate environment ( P = .0032 ) .
-RESULTS	A significant difference ( P = .0048 ) in estimates of sweat sodium concentration was evident when calculated from the forearm average ( mean 95 % CL ; 64 12 mmol/L ) compared with using a 4-site equation ( 70 12 mmol/L ) .
-RESULTS	There was a high correlation between the values produced using different analytical techniques ( r2 = .95 ) , but mean values were different between treatments ( frozen FP , frozen SC > immediate ISE > frozen ISE ; P < .0001 ) .
-CONCLUSIONS	Whole-body sweat sodium concentration estimates differed depending on the number of sites included in the calculation .
-CONCLUSIONS	Environmental testing conditions should be considered in the interpretation of results .
-CONCLUSIONS	The impact of sample freezing and subsequent analytical technique was small but statistically significant .
-CONCLUSIONS	Nevertheless , when undertaken using a standardized protocol , the regional absorbent-patch method appears to be a relatively robust field test .
-
-###25897156
-OBJECTIVE	Neurotoxic effects of brain irradiation include cognitive impairment in 50 % to 90 % of patients .
-OBJECTIVE	Prior studies have suggested that donepezil , a neurotransmitter modulator , may improve cognitive function .
-METHODS	A total of 198 adult brain tumor survivors 6 months after partial - or whole-brain irradiation were randomly assigned to receive a single daily dose ( 5 mg for 6 weeks , 10 mg for 18 weeks ) of donepezil or placebo .
-METHODS	A cognitive test battery assessing memory , attention , language , visuomotor , verbal fluency , and executive functions was administered before random assignment and at 12 and 24 weeks .
-METHODS	A cognitive composite score ( primary outcome ) and individual cognitive domains were evaluated .
-RESULTS	Of this mostly middle-age , married , non-Hispanic white sample , 66 % had primary brain tumors , 27 % had brain metastases , and 8 % underwent prophylactic cranial irradiation .
-RESULTS	After 24 weeks of treatment , the composite scores did not differ significantly between groups ( P = .48 ) ; however , significant differences favoring donepezil were observed for memory ( recognition , P = .027 ; discrimination , P = .007 ) and motor speed and dexterity ( P = .016 ) .
-RESULTS	Significant interactions between pretreatment cognitive function and treatment were found for cognitive composite ( P = .01 ) , immediate recall ( P = .05 ) , delayed recall ( P = .004 ) , attention ( P = .01 ) , visuomotor skills ( P = .02 ) , and motor speed and dexterity ( P < .001 ) , with the benefits of donepezil greater for those who were more cognitively impaired before study treatment .
-CONCLUSIONS	Treatment with donepezil did not significantly improve the overall composite score , but it did result in modest improvements in several cognitive functions , especially among patients with greater pretreatment impairments .
-
-###25059851
-BACKGROUND	Cryotherapy has been used to enhance recovery after orthopaedic surgery .
-BACKGROUND	Several cooling devices are available but few can guarantee a fixed temperature during a prolonged time and therefore have been criticized .
-BACKGROUND	The arrival of new advanced cryotherapy devices made it possible to test the effect of prolonged cooling on rehabilitation after joint replacement .
-OBJECTIVE	The hypotheses of this randomized controlled trial ( RCT ) were that advanced cryotherapy devices compared with cold packs result in ( 1 ) better postoperative pain control resulting in a lower consumption of narcotics ; ( 2 ) better early ROM ; and ( 3 ) less postoperative bleeding and swelling .
-METHODS	A priori sample size calculation had determined that to detect a difference of 2 points on the VAS , a sample size of 50 subjects per group at followup would be required , given a study power of 80 % .
-METHODS	One hundred sixteen patients were included and randomly allocated to receive advanced cryotherapy ( n = 58 ) or use of cold packs ( n = 58 ) .
-METHODS	The primary outcomes for the study were to evaluate pain with the VAS and analgesics consumption .
-METHODS	Secondary outcomes were postoperative ROM , swelling , and blood loss .
-METHODS	One hundred ( 50 in each group ) patients had complete data available for analysis .
-RESULTS	No statistically significant differences in VAS , need for analgesics , nor in secondary outcomes were observed , except for substantially reduced flexion at 6 weeks in the advanced cryotherapy group ( 114 versus 120 ) .
-CONCLUSIONS	Advanced cryotherapy with a continuous temperature for a prolonged period does not deliver expected results of superior early recovery after knee arthroplasty .
-CONCLUSIONS	Greater sample sizes are required to fully determine significant differences between the two techniques for these study parameters .
-CONCLUSIONS	Immobilization of the knee in extension during the prolonged cryotherapy session resulted in lower active flexion at 6 weeks after surgery for the advanced cryotherapy group .
-CONCLUSIONS	Advanced cryotherapy should not be used in fast track knee arthroplasty if the economic cost is higher than the price of cold packs or offers no other concomitant advantages .
-METHODS	Level II , therapeutic study .
-METHODS	See the Instructions for Authors for a complete description of levels of evidence .
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-###25681488
-OBJECTIVE	We aim to test the effectiveness , accuracy , and usefulness of an automated feedback system in facilitating skill acquisition in virtual reality surgery .
-METHODS	We evaluate the performance of the feedback system through a randomized controlled trial of 24 students allocated to feedback and nonfeedback groups .
-METHODS	The feedback system was based on the Melbourne University temporal bone surgery simulator .
-METHODS	The study was conducted at the simulation laboratory of the Royal Victorian Eye and Ear Hospital , Melbourne .
-METHODS	The study participants were medical students from the University of Melbourne , who were asked to perform virtual cortical mastoidectomy on the simulator .
-METHODS	The extent to which the drilling behavior of the feedback and nonfeedback groups differed was used to evaluate the effectiveness of the system .
-METHODS	Its accuracy was determined through a postexperiment observational assessment of recordings made during the experiment by an expert surgeon .
-METHODS	Its usability was evaluated using students ' self-reports of their impressions of the system .
-RESULTS	A Friedman 's test showed that there was a significant improvement in the drilling performance of the feedback group , ( 2 ) ( 1 ) = 14.450 , P < .001 .
-RESULTS	The postexperiment assessment demonstrated that the system provided timely feedback ( when trainee behavior was detected ) 88.6 % of the time and appropriate feedback ( accurate advice ) 84.2 % of the time .
-RESULTS	Participants ' opinions about the usefulness of the system were highly positive .
-CONCLUSIONS	The automated feedback system was observed to be effective in improving surgical technique , and the provided feedback was found to be accurate and useful .
-
-###25527262
-BACKGROUND	The efficacy of warm-up and stretching in weight-lifting remains unknown , especially for the weight-lifter 's stability and balance during lifting .
-METHODS	13 subjects were randomly assigned a 10-minute stretching routine ( SR ) or a 10-minute warm-up routine ( WR ) and compared against 5 controls ( no stretching or warm-up ) .
-METHODS	Before and after the individually assigned routine , the participants ' centre of pressure ( CoP ) was assessed using plantar-pressure sensors .
-METHODS	The subjects were measured during 10 repetitions of air squat ( no load , `` AS '' ) , front squat ( FS ; 20 kg/15 kg bar ) , overhead squat ( OHS ; m : 20 kg / f : 15 kg bar ) , and a deadlift lifting exercise ( `` DL '' ; 20 kg/15 kg bar ) .
-METHODS	The impact on CoP dynamics of the warm-up and stretching routines were examined with repeated two-factor analysis of variances ( ANOVA ) of the mean and the coefficient of variance ( CV , shown in % ) , as proxies for stability and balance .
-RESULTS	After stretching , the SR athletes shifted the mean CoP towards the toes ( 1 cm ; p < 0.01 ) while the WR athletes shifted the CoP towards the heels ( 1 cm ; p < 0.01 ) during AS .
-RESULTS	For the remaining exercises , the SR athletes shifted the CoP towards the heels ( between 0.8 cm and 5.7 cm ) compared to WR ( 1.9 cm towards the heels in FS , no significant change in OHS ( 1 mm ) and DL ( 3 mm ) ) .
-RESULTS	The controls did not show any change between pre - and post-datasets .
-RESULTS	After stretching , the CV decreased for the AS and OHS exercises ( AS : 10.2 % to 7.0 % , OHS 9.8 % to 7.8 % ) , but increased after WR ( AS : 7.1 % to 10.1 % ) or did not change significantly ( OHS ) .
-RESULTS	Both WR and SR resulted in increased CV values for FS and DL .
-RESULTS	No change of CV was observed in the controls .
-CONCLUSIONS	SR had a stronger impact on CoP during the assessed exercises than either WR or controls .
-CONCLUSIONS	A reduction in CV after SR exercises ( AS , OHS ) suggests a clear improvement in stability and balance during weight-lifting .
-CONCLUSIONS	The lack of a significant effect for complex movements ( OHS ) suggests only a limited effect of a 10-minute warm-up routine on CoP features .
-CONCLUSIONS	10 minutes stretching might therefore be more efficient for improving stability than a general 10 minute warm-up .
-
-###24295397
-BACKGROUND	Effective diabetes prevention strategies that can be implemented in daily practice , without huge amounts of money and a lot of personnel are needed .
-BACKGROUND	The Dutch Diabetes Federation developed a protocol for coaching people with impaired fasting glucose ( IFG ; according to WHO criteria : 6.1 to 6.9 mmol/l ) to a sustainable healthy lifestyle change : ` the road map towards diabetes prevention ' ( abbreviated : Road Map : RM ) .
-BACKGROUND	This protocol is applied within a primary health care setting by a general practitioner and a practice nurse .
-BACKGROUND	The feasibility and ( cost - ) effectiveness of care provided according to the RM protocol will be evaluated .
-METHODS	A cluster randomised clinical trial is performed , with randomisation at the level of the general practices .
-METHODS	Both opportunistic screening and active case finding took place among clients with high risk factors for diabetes .
-METHODS	After IFG is diagnosed , motivated people in the intervention practices receive 3-4 consultations by the practice nurse within one year .
-METHODS	During these consultations they are coached to increase the level of physical activity and healthy dietary habits .
-METHODS	If necessary , participants are referred to a dietician , physiotherapist , lifestyle programs and/or local sports activities .
-METHODS	The control group receives care as usual .
-METHODS	The primary outcome measure in this study is change in Body Mass Index ( BMI ) .
-METHODS	Secondary outcome measures are waist circumference , physical activity , total and saturated fat intake , systolic blood pressure , blood glucose , total cholesterol , HDL cholesterol , triglycerides and behaviour determinants like risk perception , perceived knowledge and motivation .
-METHODS	Based on a sample size calculation 120 people in each group are needed .
-METHODS	Measurements are performed at baseline , and after one ( post-intervention ) and two years follow up .
-METHODS	Anthropometrics and biochemical parameters are assessed in the practices and physical activity , food intake and their determinants by a validated questionnaire .
-METHODS	The cost-effectiveness is estimated by using the Chronic Disease Model ( CDM ) .
-METHODS	Feasibility will be tested by interviews among health care professionals .
-CONCLUSIONS	The results of the study will provide valuable information for both health care professionals and policy makers .
-CONCLUSIONS	If this study shows the RM to be both effective and cost-effective the protocol can be implemented on a large scale .
-BACKGROUND	ISRCTN41209683 .
-BACKGROUND	Ethical approval number : NL31342 .075.10 .
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-###25289942
-BACKGROUND	Bronchodilator therapy represents a potentially valuable therapeutic option to increase exercise tolerance and enhance lung function in mild to moderate chronic obstructive pulmonary disease ( COPD ) .
-OBJECTIVE	To determine effects of tiotropium on pulmonary hyperinflation and exercise tolerance in patients with symptomatic Global Initiative for Chronic Obstructive Lung Disease ( GOLD ) 1 and 2 COPD who experienced inspiratory capacity decrease greater than or equal to 100 ml during incremental and constant work rate treadmill exercise .
-METHODS	This 22-week , randomized , double-blind , two-period crossover study evaluated the efficacy of once-daily tiotropium bromide ( 18 g ) versus placebo in patients with GOLD 1 and 2 COPD .
-METHODS	Primary endpoint was between-group ( tiotropium vs. placebo ) difference in inspiratory capacity at isotime ( i.e. , at the time the shortest test ended ) during constant work rate treadmill exercise from baseline to the end of a 6-week treatment period .
-METHODS	Key secondary endpoints included differences in exercise duration and exertional dyspnea .
-METHODS	Safety was assessed by recording adverse events .
-RESULTS	Study population comprised 48 patients with GOLD 1 COPD and 78 patients with GOLD 2 COPD .
-RESULTS	Resting inspiratory capacity significantly improved with tiotropium versus placebo in the overall ( P < 0.0001 ) , GOLD 1 ( P = 0.0183 ) , and GOLD 2 ( P < 0.0001 ) groups .
-RESULTS	Isotime inspiratory capacity was significantly enhanced during exercise in the overall ( P = 0.0087 ) and GOLD 2 ( P = 0.0494 ) groups after tiotropium versus placebo .
-RESULTS	Tiotropium versus placebo significantly enhanced exercise duration in the GOLD 2 group ( P = 0.0070 ) but not in the GOLD 1 or overall patient groups .
-RESULTS	In the overall group , increase in exercise duration seen with tiotropium was well correlated with the increase in isotime inspiratory capacity ( r = 0.463 , P < 0.0001 ) .
-CONCLUSIONS	Resting and exercise hyperinflation were ameliorated by bronchodilator therapy with tiotropium in the overall GOLD 1 plus 2 COPD group .
-CONCLUSIONS	Exercise tolerance was enhanced in GOLD 2 , but not GOLD 1 , COPD .
-CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT01072396 ) .
-
-###24552318
-BACKGROUND	Standard therapy for newly diagnosed glioblastoma is radiotherapy plus temozolomide .
-BACKGROUND	In this phase 3 study , we evaluated the effect of the addition of bevacizumab to radiotherapy-temozolomide for the treatment of newly diagnosed glioblastoma .
-METHODS	We randomly assigned patients with supratentorial glioblastoma to receive intravenous bevacizumab ( 10 mg per kilogram of body weight every 2 weeks ) or placebo , plus radiotherapy ( 2 Gy 5 days a week ; maximum , 60 Gy ) and oral temozolomide ( 75 mg per square meter of body-surface area per day ) for 6 weeks .
-METHODS	After a 28-day treatment break , maintenance bevacizumab ( 10 mg per kilogram intravenously every 2 weeks ) or placebo , plus temozolomide ( 150 to 200 mg per square meter per day for 5 days ) , was continued for six 4-week cycles , followed by bevacizumab monotherapy ( 15 mg per kilogram intravenously every 3 weeks ) or placebo until the disease progressed or unacceptable toxic effects developed .
-METHODS	The coprimary end points were investigator-assessed progression-free survival and overall survival .
-RESULTS	A total of 458 patients were assigned to the bevacizumab group , and 463 patients to the placebo group .
-RESULTS	The median progression-free survival was longer in the bevacizumab group than in the placebo group ( 10.6 months vs. 6.2 months ; stratified hazard ratio for progression or death , 0.64 ; 95 % confidence interval [ CI ] , 0.55 to 0.74 ; P < 0.001 ) .
-RESULTS	The benefit with respect to progression-free survival was observed across subgroups .
-RESULTS	Overall survival did not differ significantly between groups ( stratified hazard ratio for death , 0.88 ; 95 % CI , 0.76 to 1.02 ; P = 0.10 ) .
-RESULTS	The respective overall survival rates with bevacizumab and placebo were 72.4 % and 66.3 % at 1 year ( P = 0.049 ) and 33.9 % and 30.1 % at 2 years ( P = 0.24 ) .
-RESULTS	Baseline health-related quality of life and performance status were maintained longer in the bevacizumab group , and the glucocorticoid requirement was lower .
-RESULTS	More patients in the bevacizumab group than in the placebo group had grade 3 or higher adverse events ( 66.8 % vs. 51.3 % ) and grade 3 or higher adverse events often associated with bevacizumab ( 32.5 % vs. 15.8 % ) .
-CONCLUSIONS	The addition of bevacizumab to radiotherapy-temozolomide did not improve survival in patients with glioblastoma .
-CONCLUSIONS	Improved progression-free survival and maintenance of baseline quality of life and performance status were observed with bevacizumab ; however , the rate of adverse events was higher with bevacizumab than with placebo .
-CONCLUSIONS	( Funded by F. Hoffmann-La Roche ; ClinicalTrials.gov number , NCT00943826 . )
-
-###25322274
-BACKGROUND	Metabolic syndrome ( MetS ) is associated with low-grade inflammation , which may harmfully affect bone .
-BACKGROUND	Resveratrol ( RSV ) possesses anti-inflammatory properties , and rodent studies suggest bone protective effects .
-OBJECTIVE	This study sought to evaluate effects of RSV treatment on bone in men with MetS .
-METHODS	The study was conducted at Aarhus University Hospital as a randomized , double-blinded , placebo-controlled trial assessing changes in bone turnover markers , bone mineral density ( BMD ) , and geometry .
-METHODS	The study population comprised 74 middle-aged obese men with MetS recruited from the general community , of which 66 completed all visits .
-METHODS	Mean age of participants was 49.3 6.3 years and mean body mass index was 33.7 3.6 kg/m ( 2 ) .
-METHODS	Oral treatment with 1.000 mg RSV ( RSV ( high ) ) , 150 mg RSV ( RSV ( low ) ) , or placebo daily for 16 weeks .
-METHODS	Prespecified primary endpoint was change in bone alkaline phosphatase ( BAP ) .
-RESULTS	BAP increased dose dependently with RSV ( R = 0.471 , P < .001 ) , resulting in a significantly greater increase in BAP in the RSV ( high ) group compared with placebo at all time-points ( week 4 , 16.4 4.2 % , P < .001 ; week 8 , 16.5 4.1 % , P < .001 ; week 16 , 15.2 3.7 % , P < .001 ) .
-RESULTS	Lumbar spine trabecular volumetric bone mineral density ( LS vBMD ( trab ) ) also increased dose dependently with RSV ( R = 0.268 , P = .036 ) , with a significant increase of 2.6 1.3 % in the RSV ( high ) group compared with placebo ( P = .043 ) .
-RESULTS	In addition , changes in BAP and LS vBMD ( trab ) were positively correlated ( R = 0.281 , P = .027 ) .
-RESULTS	No consistent changes were detected in bone density at the hip .
-CONCLUSIONS	Our data suggest that high-dose RSV supplementation positively affects bone , primarily by stimulating formation or mineralization .
-CONCLUSIONS	Future studies of longer duration comprising populations at risk of osteoporosis are needed to confirm these results .
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-###24859962
-OBJECTIVE	To study the safety and feasibility of fast track surgery ( FTS ) in the promotion of postoperative recovery for gastric cancer patients undergoing gastrectomy .
-METHODS	From January to December in 2013 , 71 gastric cancer patients were prospectively enrolled and randomized into the FTS group and the control group .
-METHODS	Patient in the FTS group received FTS management and those in the control group received routine management .
-METHODS	The postoperative recovery and stress were compared between the two groups .
-RESULTS	FTS was associated with shorter time to bowel function return [ ( 67.819.7 ) h vs. ( 90.020.6 ) h , P < 0.01 ] , shorter hospital stay [ ( 13.53.0 ) d vs. ( 17.87.3 ) d , P = 0.01 ] , lower hospital cost [ ( 23.83.7 ) thousand Yuan vs. ( 27.86.1 ) thousand Yuan , P < 0.05 ] , and less stress response ( lower pain score , WBC count , C-reactive protein , all P < 0.01 ) .
-RESULTS	The postoperative complications including ileus , infection , anastomotic leakage were similar ( all P > 0.05 ) .
-CONCLUSIONS	Fast track surgery decreases postoperative stress response and promotes recovery .
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-###24326780
-OBJECTIVE	Deficits in quadriceps strength and voluntary activation are common following knee injury .
-OBJECTIVE	These deficits are hypothesized to generate from a neural level , however , it remains unclear how corticomotor pathways are affected following acute injury .
-OBJECTIVE	The purpose of this investigation was to examine whether corticomotor alterations of the quadriceps were present following a simulated knee joint injury using an experimental effusion model .
-METHODS	Participants completed two testing sessions , an experimental knee effusion and control session , separated by 7days .
-METHODS	The central activation ratio was used to assess change in quadriceps activation .
-METHODS	Corticomotor excitability was assessed pre - and post-intervention via active motor thresholds ( AMTs ) and motor evoked potentials ( MEPs ) normalized to maximal muscle responses .
-METHODS	MEPs were assessed at different percentages of AMT , and associated slopes between these percentages were analysed .
-METHODS	Paired-sample t tests were performed on percentage change scores calculated from pre-intervention outcome measures to assess change in corticomotor excitability and changes in the slope of MEP values as percentage of AMT increased .
-RESULTS	Quadriceps activation significantly decreased during the effusion session .
-RESULTS	AMT and MEP change scores were not different between effusion and control conditions .
-RESULTS	No substantial differences were found in slope between any percentages of AMT .
-CONCLUSIONS	An experimental knee effusion did not induce changes in corticomotor excitability .
-CONCLUSIONS	Further research is needed to understand how corticomotor pathways are affected following joint injury .
-CONCLUSIONS	Corticomotor excitability alterations may not be the cause of acute changes in neuromuscular activation following joint effusion .
-CONCLUSIONS	Future research should determine whether clinically altering corticomotor excitability will improve physical function .
-METHODS	II .
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-###25720712
-OBJECTIVE	We performed this study to investigate the effect of blood pressure control in ultra-early basal ganglia intracerebral hemorrhage .
-METHODS	120 patients with ultra-early basal ganglia intracerebral hemorrhage were randomly divided into experimental group ( strengthened antihypertensive ) and control ( normal antihypertensive ) .
-METHODS	Each group consists of 60 patients , whose contractive pressure were controlled by intravenous antihypertensive drugs among 130-140 mmHg and 160-180 mmHg respectively for 24 h , after 1 h of beginning treatment .
-METHODS	They were all evaluated by NIH Stroke Scale ( NIHSS ) before and after the treatment .
-METHODS	Cranial CT , hematoma volume , hematoma enlargement , edema volume , serum matrix metalloproteinase-9 level were performed and compared between groups .
-RESULTS	After 24 h , hematoma volume and hematoma enlargement in the experimental group was significantly lower than control ( p < 0.05 ) .
-RESULTS	After 14 days , NIHSS score in the experimental group was significantly lower than control ( p < 0.05 ) .
-RESULTS	Cerebral edema amount and serum MMP-9 level in the experimental group were significantly lower than control after 5 days and 14 days .
-CONCLUSIONS	Ultra-early basal ganglia intracerebral hemorrhage can remarkably reduce hematoma enlargement , cerebral edema , serum MMP-9 level , and improve the neurological function .
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-###26044854
-BACKGROUND	It has frequently been speculated that pruritus and skin lesions develop after topical exposure to aeroallergens in sensitized patients with atopic dermatitis ( AD ) .
-OBJECTIVE	We sought to study cutaneous reactions to grass pollen in adult patients with AD with accompanying clear IgE sensitization to grass allergen in an environmental challenge chamber using a monocenter , double-blind , placebo-controlled study design .
-METHODS	Subjects were challenged on 2 consecutive days with either 4000 pollen grains/m ( 3 ) of Dactylis glomerata pollen or clean air .
-METHODS	The severity of AD was assessed at each study visit up to 5 days after challenge by ( objective ) scoring of AD ( SCORAD ) .
-METHODS	Additionally , air-exposed and non-air-exposed skin areas were each scored using local SCORAD scoring and investigator global assessments .
-METHODS	Levels of a series of serum cytokines and chemokines were determined by using a Luminex-based immunoassay .
-METHODS	The primary end point of the study was the change in objective SCORAD scores between prechallenge and postchallenge values .
-RESULTS	Exposure to grass pollen induced a significant worsening of AD .
-RESULTS	A pronounced eczema flare-up of air-exposed rather than covered skin areas occurred .
-RESULTS	In grass pollen-exposed subjects a significantly higher increase in CCL17 , CCL22 , and IL-4 serum levels was observed .
-CONCLUSIONS	This study demonstrates that controlled exposure to airborne allergens of patients with a so-called extrinsic IgE-mediated form of AD induced a worsening of cutaneous symptoms .
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-###24621069
-OBJECTIVE	Certain plant polysaccharides may provide psychological health benefits .
-OBJECTIVE	The aim of this study was to evaluate whether they can acutely improve mood and cognitive function .
-METHODS	In a randomized , double-blind , placebo-controlled , between subjects design trial , 73 middle-aged adults consumed 4 g of a proprietary mixture of non-starch polysaccharides ( NSPs ) ( Ambrotose complex ) , a rice flour placebo , or a sucrose control .
-METHODS	Participants completed testing at baseline and 30 minutes post-consumption .
-METHODS	Acute effects of consumption on mood , cognition , and blood glucose were evaluated during mental tests designed to induce mental fatigue .
-RESULTS	Significant improvement in recognition and working memory performance was observed in the group that consumed NSP compared with placebo or sucrose .
-RESULTS	Improvements in memory performance following NSP intake were independent of changes in blood glucose .
-CONCLUSIONS	This is the first report of acute behavioural improvement following plant polysaccharide intake in healthy middle-aged adults under conditions of mental fatigue .
-CONCLUSIONS	The findings suggest that certain NSP may enhance memory performance through mechanisms other than elevated blood glucose .
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-###24302188
-BACKGROUND	Approximately 0.5-2 % of upper respiratory tract infections in adults and 6-13 % of viral upper respiratory tract infections in children are complicated by acute sinusitis .
-BACKGROUND	This study was aimed to evaluate the coadministration effect of fluticasone nasal spray ( FNS ) with amoxicillin for AS in children .
-METHODS	One hundred children 2 to 14 years of age with acute sinusitis referred to Shahid Mohammadi Pediatric Hospital in Bandar Abbas were randomly allocated into two equal intervention and control groups to receive amoxicillin with fluticasone nasal spray one puff twice daily for 14 days and amoxicillin 80 to 100 mg/kg / day for 14 days respectively .
-RESULTS	Twenty one ( 42 % ) of children in intervention group were cured completely and 2 ( 4 % ) children in control group had complete recovery ( p < 0.001 ) .
-RESULTS	Symptom severity score was 22.98 2.95 before treatment that reduced to 13.26 3.20 after treatment ( p < 0.001 ) .
-CONCLUSIONS	Use of fluticasone can reduce the severity of symptoms of sinusitis in children .
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-###25919921
-OBJECTIVE	Test the efficacy of SmartLoss , a smartphone-based weight loss intervention , in a pilot study .
-METHODS	A 12-week randomized controlled trial .
-METHODS	Adults ( 25BMI35 kg/m2 ) were randomized to SmartLoss ( n = 20 ) or an attention-matched Health Education control group ( n = 20 ) .
-METHODS	SmartLoss participants were prescribed a 1,200 to 1,400 kcal/d diet and were provided with a smartphone , body weight scale , and accelerometer that wirelessly transmitted body weight and step data to a website .
-METHODS	In the SmartLoss Group , mathematical models were used to quantify dietary adherence based on body weight and counselors remotely delivered treatment recommendations based on these objective data .
-METHODS	The Health Education group received health tips via smartphone .
-METHODS	A mixed model determined if change in weight and other endpoints differed between the groups ( baseline was a covariate ) .
-RESULTS	The sample was 82.5 % female .
-RESULTS	MeanSD baseline age , weight ( kg ) , and BMI were 44.411.8 years , 80.311.5 kg , and 29.82.9 kg/m2 , respectively .
-RESULTS	One participant was lost to follow-up in each group before week 4 .
-RESULTS	Weight loss was significantly ( P < 0.001 ) larger in the SmartLoss ( least squares meanSEM : -9.40.5 % ) compared with the Health Education group ( -0.60.5 % ) .
-CONCLUSIONS	SmartLoss efficaciously promote clinically meaningful weight loss compared with an attention-matched control group .
-CONCLUSIONS	Smartphone-based interventions might prove useful in intervention dissemination .
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-###25008880
-OBJECTIVE	To study the therapeutic effects of different doses of botulinum toxin A ( BTX-A ) injection on tiptoe deformation in children with cerebral palsy .
-METHODS	A total of 256 children with tiptoe deformation due to spastic cerebral palsy were classified into group A ( muscle tension levels I-II , n = 147 ) and group B ( muscle tension levels III-IV , n = 109 ) .
-METHODS	Group A was randomly divided into group A1 ( injected with high-dose BTX-A , n = 73 ) and group A2 ( injected with low-dose BTX-A , n = 74 ) .
-METHODS	Group B was randomly divided into group B1 ( injected with high-dose BTX-A , n = 55 ) and group B2 ( injected with low-dose BTX-A , n = 54 ) .
-METHODS	The dose of BTX-A was 6 U/kg for groups A1 and B1 and was 3 U/kg for groups A2 and B2 .
-METHODS	Before the injection and at 1,2,6 , and 12 months after injection , the muscle tension of limbs was evaluated with the modified Ashworth Scale , and the recovery of motor function of lower limbs was assessed with the Gross Motor Function Measure ( GMFM ) .
-RESULTS	Before and after treatment , there were no significant differences in Ashworth and GMFM scores between groups A1 and A2 ( P > 0.05 ) .
-RESULTS	After treatment , group B1 had a significantly reduced Ashworth score and a significantly increased GMFM score , and group B1 had a significantly lower Ashworth score and a significantly higher GMFM score compared with group B2 ( P < 0.05 ) .
-RESULTS	For groups A and B , Ashworth score gradually declined post-treatment , reached the lowest point at 3 months after treatment , and returned to the level before treatment at 12 months after treatment ; GMFM score gradually increased post-treatment and reached the peak level at 12 months after treatment ( P < 0.05 ) .
-CONCLUSIONS	The level of muscle tension should be considered when BTX-A injection is used for treating tiptoe deformation in children with cerebral palsy .
-CONCLUSIONS	It makes no difference to use high - or low-dose BTX-A when the muscle tension level is within I-II , but high-dose BTX-A has a better performance in reducing muscle tension and improving motor function when the muscle tension level is within III-IV .
-
-###25371534
-BACKGROUND	Human immunodeficiency virus ( HIV ) - infected individuals are at increased risk of herpes zoster ( HZ ) , even in the antiretroviral therapy ( ART ) era .
-BACKGROUND	Because concerns exist about the use of live-attenuated vaccines in immunocompromised individuals , a subunit vaccine may be an appropriate alternative .
-METHODS	This phase 1/2 , randomized , placebo-controlled study evaluated the immunogenicity and safety of an investigational HZ subunit vaccine ( HZ/su ) .
-METHODS	Three cohorts of HIV-infected adults aged 18 years were enrolled : 94 ART recipients with a CD4 ( + ) T-cell count of 200 cells/mm ( 3 ) , 14 ART recipients with a CD4 ( + ) T-cell count of 50-199 cells/mm ( 3 ) , and 15 ART-naive adults with a CD4 ( + ) T-cell count of 500 cells/mm ( 3 ) .
-METHODS	Subjects received 3 doses of HZ/su ( 50 g varicella-zoster virus glycoprotein E [ gE ] combined with AS01B adjuvant ) or 3 doses of saline at months 0 , 2 , and 6 .
-RESULTS	One month after dose 3 , serum anti-gE antibody concentrations and frequencies of gE-specific CD4 ( + ) T cells were higher following HZ/su vaccination than after receipt of saline ( P < .0001 ) .
-RESULTS	Median cell-mediated immune responses peaked after dose 2 .
-RESULTS	Humoral and cell-mediated immune responses persisted until the end of the study ( month 18 ) .
-RESULTS	No vaccination-related serious adverse events were reported .
-RESULTS	No sustained impact on HIV load or CD4 ( + ) T-cell count was noted following vaccinations .
-CONCLUSIONS	HZ/su was immunogenic and had a clinically acceptable safety profile in HIV-infected adults .
-BACKGROUND	NCT01165203 .
-
-###25600198
-OBJECTIVE	To describe the incidence and outcomes of endophthalmitis after intravitreal injections of anti-vascular endothelial growth factor agents in the Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) and to assess the effect of prophylactic topical antimicrobials on incidence .
-METHODS	Cohort study within a randomized clinical trial .
-METHODS	Patients enrolled in CATT .
-METHODS	Patients with neovascular age-related macular degeneration received intravitreal injections of ranibizumab or bevacizumab under 1 of 3 dosing regimens .
-METHODS	The study protocol specified preinjection preparation to include use of a sterile lid speculum and povidone iodine ( 5 % ) .
-METHODS	Use of preinjection and postinjection antibiotics was at the discretion of the treating ophthalmologist .
-METHODS	Patients were followed up monthly for 2 years .
-METHODS	Development of endophthalmitis and visual acuity .
-RESULTS	Endophthalmitis developed after 11 of 18 509 injections ( 1 per 1700 [ 0.06 % ] ; 95 % confidence interval , 0.03 % -0.11 % ) , and in 11 of 1185 patients ( 0.93 % ; 95 % confidence interval , 0.52-1 .66 ) .
-RESULTS	Incidence of endophthalmitis was 0.15 % among injections with no antibiotic use , 0.08 % among injections with preinjection antibiotics only , 0.06 % among injections with postinjection antibiotics only , and 0.04 % among injections with preinjection and postinjection antibiotics ( P = 0.20 ) .
-RESULTS	All eyes were treated with intravitreal antibiotics and 4 underwent vitrectomy .
-RESULTS	Among the 11 affected eyes , the final study visual acuity was 20/40 or better in 4 eyes ( 36 % ) , 20/50 to 20/80 in 2 eyes ( 18 % ) , 20/100 to 20/160 in 3 eyes ( 27 % ) , and worse than 20/800 in 2 eyes ( 18 % ) .
-RESULTS	The final visual acuity was within 2 lines of the visual acuity before endophthalmitis in 5 eyes ( 45 % ) .
-CONCLUSIONS	Rates of endophthalmitis were low and similar to those in other large-scale studies .
-CONCLUSIONS	Use of topical antibiotics either before or after injection does not seem to reduce the risk for endophthalmitis .
-
-###24529669
-BACKGROUND	Etomidate is a hypnotic drug widely used as an intravenous anesthetic induction agent .
-BACKGROUND	The incidence of etomidate-induced myoclonus has been reported as much as 50-80 % after induction making it an undesirable drug for induction .
-OBJECTIVE	Our aim is to use a priming dose of atracurium to suppress etomidate-induced myoclonus during induction of anesthesia .
-METHODS	In a double-blinded clinical trial 80 patients were randomly given either atracurium ( 20 % of ED95 kg ) or saline as a priming agent .
-METHODS	Then , induction of anesthesia was performed using 0.4 mg/kg etomidate .
-METHODS	Age , weight , body mass index , bispectral index ( BIS ) monitor , and duration and grade of myoclonus were recorded .
-RESULTS	The demographic characteristics , age , body mass index , BIS score , and weight were not significantly different between the atracurium ( ATRA ) priming group and control groups .
-RESULTS	The binomial regression model showed that BMI was an independent predictor variable for myoclonus ( OR : 2.1 , CI 95 % : 1.7-7 .5 , p = 0.032 ) .
-RESULTS	In this model , adjusted odds ratios ( OR ) of myoclonus ( multivariate logistic regression analysis ) in the control group was 6.6 ( 95 % CI : 1.5-9 .7 , p = 0.013 ) .
-CONCLUSIONS	Low-dose atracurium priming could effectively suppress etomidate-induced myoclonus .
-
-###24982492
-BACKGROUND	Telehealth is an emerging field of clinical practice but current UK health policy has not taken account of the perceptions of front-line healthcare professionals expected to implement it .
-OBJECTIVE	To investigate telehealth care for people with long-term conditions from the perspective of the front-line health professional .
-METHODS	A qualitative study in three sites within the UK ( Kent , Cornwall , and the London Borough of Newham ) and embedded in the Whole Systems Demonstrator evaluation , a large cluster randomised controlled trial of telehealth and telecare for patients with long-term and complex conditions .
-METHODS	Semi-structured qualitative interviews with 32 front-line health professionals ( 13 community matrons , 10 telehealth monitoring nurses and 9 GPs ) involved in the delivery of telehealth .
-METHODS	Data were analysed using a modified grounded theory approach .
-RESULTS	Mixed views were expressed by front-line professionals , which seem to reflect their levels of engagement .
-RESULTS	It was broadly welcomed by nursing staff as long as it supplemented rather than substituted their role in traditional patient care .
-RESULTS	GPs held mixed views ; some gave a cautious welcome but most saw telehealth as increasing their work burden and potentially undermining their professional autonomy .
-CONCLUSIONS	Health care professionals will need to develop a shared understanding of patient self-management through telehealth .
-CONCLUSIONS	This may require a renegotiation of their roles and responsibilities .
-
-###25098377
-BACKGROUND	Patients with end-stage kidney disease ( ESKD ) have a high rate of mortality and specifically an increased risk of sudden cardiac death ( SCD ) .
-BACKGROUND	Impaired cardiac autonomic tone is associated with elevated risk of SCD .
-BACKGROUND	Moreover , patients with ESKD are often vitamin D deficient , which we have shown may be linked to autonomic dysfunction in humans .
-BACKGROUND	To date , it is not known whether vitamin D supplementation normalizes cardiac autonomic function in the high-risk ESKD population .
-BACKGROUND	The VITamin D supplementation and cardiac Autonomic tone in Hemodialysis ( VITAH ) randomized trial will determine whether intensive vitamin D supplementation therapies improve cardiac autonomic tone to a greater extent than conventional vitamin D supplementation regimens in ESKD patients requiring chronic hemodialysis .
-METHODS	A total of 60 subjects with ESKD requiring thrice weekly chronic hemodialysis will be enrolled in this 2x2 crossover , blinded , randomized controlled trial .
-METHODS	Following a 4-week washout period from any prior vitamin D therapy , subjects are randomized 1:1 to intensive versus standard vitamin D therapy for 6 weeks , followed by a 12-week washout period , and finally the remaining treatment arm for 6 weeks .
-METHODS	Intensive vitamin D treatment includes alfacalcidiol ( activated vitamin D ) 0.25 mcg orally with each dialysis session combined with ergocalciferol ( nutritional vitamin D ) 50 000 IU orally once per week and placebo the remaining two dialysis days for 6 weeks .
-METHODS	The standard vitamin D treatment includes alfacalcidiol 0.25 mcg orally combined with placebo each dialysis session per week for 6 weeks .
-METHODS	Cardiac autonomic tone is measured via 24 h Holter monitor assessments on the first dialysis day of the week every 6 weeks throughout the study period .
-METHODS	The primary outcome is change in the low frequency : high frequency heart rate variability ( HRV ) ratio during the first 12 h of the Holter recording at 6 weeks versus baseline .
-METHODS	Secondary outcomes include additional measures of HRV .
-METHODS	The safety of intensive versus conventional vitamin D supplementation is also assessed .
-CONCLUSIONS	VITAH will determine whether an intensive vitamin D supplementation regimen will improve cardiac autonomic tone compared to conventional vitamin D supplementation and will assess the safety of these two supplementation regimens in ESKD patients receiving chronic hemodialysis .
-BACKGROUND	ClinicalTrials.gov , NCT01774812 .
-
-###24713186
-OBJECTIVE	Interferon ( IFN ) negatively impacts patients ' well-being and patient-reported outcomes ( PROs ) .
-OBJECTIVE	Our aim was to assess PROs during treatment with an IFN-free regimen [ sofosbuvir ( SOF ) + ribavirin ( RBV ) ] .
-METHODS	Four PRO questionnaires [ Short Form-36 ( SF-36 ) , Chronic Liver Disease Questionnaire-HCV ( CLDQ-HCV ) , Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F ) , Work Productivity and Activity Index : Specific Health Problem ( WPAI : SHP ) ] were administered at baseline , end-of-treatment and post-treatment to 334 HCV genotype 2 and 3 patients ( nave or treatment-experienced ) enrolled in the VALENCE study .
-METHODS	Of these , 250 genotype 3 patients were treated for 24 weeks while 73 genotype 2 and 11 genotype 3 patients received 12 weeks of treatment .
-RESULTS	Baseline PRO scores were similar between the two arms of the study .
-RESULTS	Throughout and after treatment , patients receiving 12 or 24 weeks had similar FACIT-F , CLDQ-HCV , SF-36 and WPAI : SHP scores ( all p > 0.05 ) .
-RESULTS	Compared to their own baseline scores , patients receiving SOF+RBV experienced modest declines in some aspects of SF-36 , CLDQ-HCV , fatigue and WPAI : SHP scores ( p = 0.04 to < 0.0001 ) .
-RESULTS	By follow-up week 12 , all PRO scores returned to the pre-treatment levels ( p > 0.05 ) .
-RESULTS	In patients achieving SVR-12 ( regardless of the regimen ) , significant improvements were noted in general health ( p = 0.0004 ) , CLDQ-HCV ( p < 0.0001 ) , fatigue ( p = 0.005 ) , emotional well-being ( p < 0.0001 ) and physical component summary score of SF-36 ( p = 0.0022 ) .
-RESULTS	In multivariate analysis , baseline depression , fatigue , insomnia , cirrhosis , and treatment-related adverse events were the most consistent predictors of PRO impairment ( all p < 0.05 ) .
-CONCLUSIONS	PROs are minimally impacted by SOF+RBV regimens .
-CONCLUSIONS	An additional 12 weeks of treatment does not substantially add to the PRO burden .
-
-###24658367
-OBJECTIVE	Despite beneficial effects on communication and process measures , client-centred practice has been shown to result in poor functional outcomes .
-OBJECTIVE	To examine a potential explanation for poor functional outcomes , this paper aims to assess whether in client-centred therapy more time is spent on diagnostic consultation and less time on actual treatment compared to usual care .
-METHODS	A multicentre cluster randomised controlled trial was performed .
-METHODS	Thirteen hospitals and rehabilitation centres , 29 therapists and 269 outpatients with multiple sclerosis participated .
-METHODS	Measurements included an inventory of diagnostic and treatment goals , the number of sessions , therapy duration and therapy intensity .
-RESULTS	In client-centred therapy , more sessions were used for diagnostic consultation ( 10.9 % points difference , p = 0.030 ) ; the time needed to formulate the first treatment goal was longer ( 11.4 days difference , p = 0.041 ) ; there was a tendency towards more goals directed to diagnostic issues ( 0.69 goals difference , p = 0.056 ) , spending more hours on indirect issues ( 1.16 h difference , p = 0.051 ) and towards a longer total therapy period ( 1.56 months difference , p = 0.058 ) than in usual care .
-CONCLUSIONS	Client-centred therapy resulted in more intensive diagnostic evaluation and less intensive treatment .
-CONCLUSIONS	This suggests that client-centred therapy should be adjusted towards a more proportional distribution of time devoted to diagnostic evaluation versus actual treatment .
-
-###25835160
-BACKGROUND	Systemic steroids are the standard treatment for bronchiolitis obliterans syndrome ( BOS ) after allogeneic hematopoietic stem cell transplantation ( HSCT ) despite their poor efficacy and disabling side effects .
-OBJECTIVE	To evaluate the effectiveness and tolerance of budesonide/formoterol as an alternative treatment for BOS after HSCT .
-METHODS	In this randomized , double-blind , placebo-controlled study , we randomly assigned 32 HSCT recipients with mild/severe BOS to receive budesonide/formoterol or placebo for 6 months .
-METHODS	The primary outcome was the change in the FEV1 after 1 month of treatment ( M1 ) compared with the baseline value .
-METHODS	Patients were unblinded at M1 if there was no improvement in the FEV1 .
-METHODS	Those who had initially received placebo were switched to budesonide/formoterol .
-METHODS	Intention-to-treat analysis was performed to assess the primary outcome .
-METHODS	Additional analyses took scheduled treatment contamination into account .
-RESULTS	At M1 , the median FEV1 increased by 260 ml in the budesonide/formoterol arm compared with 5 ml in the placebo arm ( P = 0.012 ) .
-RESULTS	The median increases in the FEV1 at M1 relative to the baseline value for the treated and placebo groups were 13 and 0 % , respectively ( P = 0.019 ) .
-RESULTS	Twenty-five patients received budesonide/formoterol during the study .
-RESULTS	The median difference in the FEV1 between the baseline and after 1 month of treatment for these patients was +240 ml ( P = 0.0001 ) .
-RESULTS	The effect of budesonide/formoterol on the FEV1 was maintained in the 13 patients who completed 6 months of treatment .
-CONCLUSIONS	Budesonide/formoterol administration led to a significant improvement in the FEV1 in patients with mild/severe BOS after allogeneic HSCT .
-CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT00624754 ) .
-
-###25029830
-OBJECTIVE	To compare the difference of anterior knee pain after total knee arthroplasty ( TKA ) between the ways using periosteal dissector and electric scalpel to release medial collateral ligament and pes anserinus .
-METHODS	From September 2009 to September 2012 , 220 patients with unilateral osteoarthritis were treated with primary TKA in hospital 301 .
-METHODS	All the patients were randomly divided into periosteal dissector group ( 110 cases ) or electric scalpel group ( 110 cases ) .
-METHODS	In the periosteal dissector group , there were 47 males and 63 females , with an average age of ( 58.8 + / - 17.2 ) years old ; the degree of genuavarus was ( 14.0 + / - 3.5 ) degrees ; the weight was ( 65.6 + / - 12.8 ) kg ; the body mass index ( BMI ) was ( 26.6 + / - 3.6 ) kg/m2 .
-METHODS	In the electric scalpel group , there were 49 males and 61 females , with an average age of ( 59.6 + / - 16.7 ) years old ; the degree of genuavarus was ( 15.0 + / - 4.7 ) degrees ; the weight was ( 66.4 + / - 13.4 ) kg ; the BMI was ( 27.4 + / - 4.1 ) kg/m2 .
-METHODS	The mean follow-up period was 24.6 months .
-METHODS	The AKS , VAS and HSS were used to evaluate clinical results .
-RESULTS	All incisions healed at the first stage ; no deep vein thrombosis of lower limbs or pulmonary embolism occurred .
-RESULTS	Knee infection occurred in 3 cases ( 1 in the periosteal dissector group and 2 in the electric scalpel group ) , and the 3 patients received stage 2 total knee revision using antibiotic bone cement and TC3 prosthesis .
-RESULTS	No recurrence of infection occurred during follow-up .
-RESULTS	Among the 20 patients who had anterior knee pain , 16 patients were in the periosteal dissector group and 4 patients were in the electric scalpel group .
-RESULTS	The occurrence rate of anterior knee pain in the electric scalpel group was lower than that in the periosteal dissector group .
-RESULTS	The AKS knee score and HSS score after total knee arthroplasty in the electric scalpel group were all higher than those in the periosteal dissector group , and the VAS in electric scalpel group was lower than that of periosteal dossector group .
-CONCLUSIONS	Compared with using electric scalpel , using periosteal dissector used to release medial collateral ligament and pes anserinus may cause more anterior knee pain after total knee arthroplasty .
-
-###24300226
-OBJECTIVE	To examine the effect of co-bedding between preterm twins on stress response after heel lance .
-METHODS	Using a multisite randomized controlled trial design , stable preterm twins ( 67 sets , N = 134 infants ) between 28 and 36 completed weeks ' gestational age , stratified by gestational age ( and > 32 weeks ) and site , were randomly assigned to a co-bedding group , cared for continuously in the same incubator or crib or a standard care group , cared for in a separate incubator or crib , and underwent a medically indicated heel lance after at least 24 hours and no greater than 10 days of group allocation .
-METHODS	The reported outcome was cortisol from saliva samples from 89 twins ( n = 49 co-bedding , n = 40 standard care ) collected immediately before the heel lance ( baseline levels ) and 113 twins ( n = 58 co-bedding , n = 55 standard care ) collected 20 minutes after heel lance ( stress levels ) as an index of stress response .
-RESULTS	No group differences were noted in baseline salivary cortisol levels : 0.36 g/dL ( SD 0.25 ) in the co-bedding group and 0.43 g/dL ( SD 0.50 ) in the standard care group .
-RESULTS	Twenty minutes after lance , levels were significantly lower in the co-bedding group , 0.28 g/dL ( SD 0.25 ) versus 0.50 g/dL ( SD 0.73 ) in the standard group ( P = 0.04 ) .
-RESULTS	Similarly , the mean of paired changes in salivary cortisol from baseline was lower in the co-bedding group ( -0.06 g/dL ) compared with the standard care group ( 0.14 g/dL , P < 0.05 ) .
-CONCLUSIONS	Co-bedding attenuates the stress response of preterm twins undergoing heel lance .
-BACKGROUND	clinicaltrials.gov Identifier : NCT009176 .
-
-###24622803
-BACKGROUND	A common obesity-risk variant rs9939609 in the fat mass - and obesity-associated ( FTO ) gene was recently shown to affect appetite , and the gene is sensitive to the regulation of amino acids .
-OBJECTIVE	We examined the interaction between FTO genotype and protein intake on the long-term changes in appetite in a randomized controlled trial .
-METHODS	We genotyped FTO rs9939609 in 737 overweight adults in the 2-y Preventing Overweight Using Novel Dietary Strategies trial and assessed 4 appetite-related traits including cravings , fullness , hunger , and prospective consumption .
-RESULTS	We showed that dietary protein significantly modified genetic effects on changes in food cravings and appetite scores at 6 mo after adjustment for age , sex , ethnicity , baseline body mass index , weight change , and baseline value for respective outcomes ( P-interaction = 0.027 and 0.048 , respectively ) .
-RESULTS	The A allele was associated with a greater decrease in food cravings and appetite scores in participants with high-protein-diet intake ( P = 0.027 and 0.047 , respectively ) but not in subjects in the low-protein-diet group ( P = 0.384 and 0.078 , respectively ) .
-RESULTS	The weight regain from 6 to 24 mo attenuated gene-protein interactions .
-RESULTS	Protein intakes did not modify FTO genotype effects on other appetite measures .
-CONCLUSIONS	Our data suggest that individuals with the FTO rs9939609 A allele might obtain more benefits in a reduction of food cravings and appetite by choosing a hypocaloric and higher-protein weight-loss diet .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT00072995 .
-
-###25768796
-BACKGROUND	Trachomatous trichiasis ( TT ) needs to be managed to reduce the risk of vision loss .
-BACKGROUND	The long-term impact of epilation ( a common traditional practice of repeated plucking of lashes touching the eye ) in preventing visual impairment and corneal opacity from TT is unknown .
-BACKGROUND	We conducted a randomized controlled trial of epilation versus surgery for the management of minor TT ( fewer than six lashes touching the eye ) in Ethiopia .
-BACKGROUND	Here we report the four-year outcome and the effect on vision and corneal opacity .
-RESULTS	1300 individuals with minor TT were recruited and randomly assigned to quality trichiasis surgery or repeated epilation using high quality epilation forceps by a trained person with good near vision .
-RESULTS	Participants were examined six-monthly for two-years , and then at four-years after randomisation .
-RESULTS	At two-years all epilation arm participants were offered free surgery .
-RESULTS	At four-years 1151 ( 88.5 % ) were re-examined : 572 ( 88 % ) and 579 ( 89 % ) from epilation and surgery arms , respectively .
-RESULTS	At that time , 21.1 % of the surgery arm participants had recurrent TT ; 189/572 ( 33 % ) of the epilation arm had received surgery , while 383 ( 67 % ) declined surgery and had continued epilating ( `` epilation-only '' ) .
-RESULTS	Among the epilation-only group , 207 ( 54.1 % ) fully controlled their TT , 166 ( 43.3 % ) had minor TT and 10 ( 2.6 % ) had major TT ( > 5 lashes ) .
-RESULTS	There were no differences between participants in the epilation-only , epilation-to-surgery and surgery arm participants in changes in visual acuity and corneal opacity between baseline and four-years .
-CONCLUSIONS	Most minor TT participants randomised to the epilation arm continued epilating and controlled their TT .
-CONCLUSIONS	Change in vision and corneal opacity was comparable between surgery and epilation-only participants .
-CONCLUSIONS	This suggests that good quality epilation with regular follow-up is a reasonable second-line alternative to surgery for minor TT for individuals who either decline surgery or do not have immediate access to surgical treatment .
-
-###24351375
-OBJECTIVE	To evaluate dexmedetomidine as adjunctive therapy to lorazepam for severe alcohol withdrawal .
-METHODS	Prospective , randomized , double-blind , placebo-controlled trial .
-METHODS	Single center ; medical ICU .
-METHODS	Twenty-four adult patients with a Clinical Institute Withdrawal Assessment score greater than or equal to 15 despite greater than or equal to 16 mg of lorazepam over a 4-hour period .
-METHODS	Patients received a symptom-triggered Clinical Institute Withdrawal Assessment protocol with lorazepam and were randomized to dexmedetomidine 1.2 g/kg/hr ( high dose ) , 0.4 g/kg/hr ( low dose ) , or placebo as adjunctive therapy for up to 5 days or resolution of withdrawal symptoms .
-RESULTS	High-dose and low-dose groups were combined as a single dexmedetomidine group for primary analysis with secondary analysis exploring a dose-response relationship .
-RESULTS	The difference in 24-hour lorazepam requirements after versus before study drug was greater in the dexmedetomidine group compared with the placebo group ( -56 mg vs -8 mg , p = 0.037 ) .
-RESULTS	Median differences were similar for high dose and low dose .
-RESULTS	The 7-day cumulative lorazepam requirements were not statistically different between dexmedetomidine and placebo ( 159 mg vs 181 mg ) .
-RESULTS	Clinical Institute Withdrawal Assessment or Riker sedation-agitation scale scores representing severe agitation ( 13 % vs 25 % ) or moderate agitation ( 27 % vs 22 % ) within 24 hours of initiating study drug were similar for dexmedetomidine and placebo groups , respectively .
-RESULTS	Bradycardia occurred more frequently in the dexmedetomidine group versus placebo group ( 25 % vs 0 % , p = not significant ) , with the majority of bradycardia occurring in the high-dose group ( 37.5 % ) .
-RESULTS	Study drug rate adjustments occurred more often in the dexmedetomidine group compared with the placebo group ( 50 % vs 0 % , p = 0.02 ) .
-RESULTS	Neither endotracheal intubation nor seizure occurred in any group while on study drug .
-CONCLUSIONS	Adjunctive dexmedetomidine for severe alcohol withdrawal maintains symptom control and reduces lorazepam exposure in the short term , but not long term , when using a symptom-triggered protocol .
-CONCLUSIONS	Monitoring for bradycardia is needed with dexmedetomidine but the occurrence may be lessened with low dose .
-CONCLUSIONS	Further study is needed to evaluate the clinical impact of dexmedetomidine .
-
-###25667217
-OBJECTIVE	The aims of this study were to assess the effects of 0.2 mL of 4 % atomized lidocaine on swallowing and tolerability during Fiberoptic Endoscopic Evaluation of Swallowing ( FEES ) .
-METHODS	A single blinded study was conducted with 17 dysphagic patients , who received 4 standardized boluses in 2 sequential FEES exams under 2 conditions : non-anesthetized ( decongestant only ) and anesthetized ( lidocaine 4 % + decongestant ) .
-METHODS	After each procedure , patients rated their pain on the Wong Baker FACES Pain Rating Scale .
-METHODS	Clinicians scored each swallow with the Penetration Aspiration Scale ( PAS ) and an author-developed Residue Rating Scale .
-METHODS	Because the assessments were ordinal , a series of Wilcoxon signed-rank tests were conducted to detect differences between the 2 conditions .
-RESULTS	No significant differences were detected between groups on PAS or residue in the 4 boluses .
-RESULTS	Pain scores , however , were significantly lower in the anesthetized condition than the decongested-only condition ( P = .035 ) .
-CONCLUSIONS	The findings of this study indicated that 0.2 mL of 4 % lidocaine enhanced exam tolerability and did not impair the swallow in dysphagic patients .
-
-###24694082
-BACKGROUND	The prevention and treatment of childhood obesity is a key public health challenge .
-BACKGROUND	However , certain groups within populations have markedly different risk profiles for obesity and related health behaviours .
-BACKGROUND	Well-designed subgroup analysis can identify potential differential effects of obesity interventions , which may be important for reducing health inequalities .
-BACKGROUND	The study aim was to evaluate the consistency of the effects of active video games across important subgroups in a randomised controlled trial ( RCT ) .
-RESULTS	A two-arm , parallel RCT was conducted in overweight or obese children ( n = 322 ; aged 10-14 years ) to determine the effect of active video games on body composition .
-RESULTS	Statistically significant overall treatment effects favouring the intervention group were found for body mass index , body mass index z-score and percentage body fat at 24 weeks .
-RESULTS	For these outcomes , pre-specified subgroup analyses were conducted among important baseline demographic ( ethnicity , sex ) and prognostic ( cardiovascular fitness ) groups .
-RESULTS	No statistically significant interaction effects were found between the treatment and subgroup terms in the main regression model ( p = 0.36 to 0.93 ) , indicating a consistent treatment effect across these groups .
-CONCLUSIONS	Preliminary evidence suggests an active video games intervention had a consistent positive effect on body composition among important subgroups .
-CONCLUSIONS	This may support the use of these games as a pragmatic public health intervention to displace sedentary behaviour with physical activity in young people .
-
-###25170252
-BACKGROUND	XARTEMIS XR ( formerly MNK-795 ) is a combination oxycodone ( OC ) and acetaminophen ( APAP ) analgesic with both immediate-release and extended-release ( ER ) components ( ER OC/APAP ) .
-BACKGROUND	The tablets are designed with gastric-retentive ER oral delivery technology that releases the ER component at a controlled rate in the upper gastrointestinal tract .
-BACKGROUND	Because consumption of food has demonstrated an impact on the pharmacokinetics ( PK ) of some marketed products using gastric-retentive ER oral delivery technology , a characterization of the effects of fed ( high - and low-fat diets ) versus fasted conditions on the PK of ER OC/APAP was performed .
-METHODS	This Phase I study used an open-label randomized single-dose three-period six-sequence crossover single-center design .
-METHODS	Healthy adult participants ( n = 48 ) were randomized to receive two tablets of ER OC/APAP under three conditions : following a high-fat meal ; following a low-fat meal ; and fasted .
-METHODS	Plasma concentration versus time data from predose throughout designated times up to 48 hours postdose was used to estimate the PK parameters of oxycodone and APAP .
-RESULTS	Thirty-one participants completed all three treatment periods .
-RESULTS	Both oxycodone and APAP were rapidly absorbed under fasted conditions .
-RESULTS	Total oxycodone and APAP exposures ( area under the plasma drug concentration-time curve [ AUC ] ) from ER OC/APAP were not significantly affected by food , and minimal changes to maximum observed plasma concentration for oxycodone and APAP were also noted .
-RESULTS	However , food marginally delayed the time to maximum observed plasma concentration of oxycodone and APAP .
-RESULTS	There was no indication that tolerability was affected by food .
-CONCLUSIONS	The findings from this study suggest that ER OC/APAP can be administered with or without food .
-
-###25318980
-BACKGROUND	Strategies to improve infant and young child nutrition in low - and middle - income countries need to be implemented at scale .
-BACKGROUND	We contextualised and packaged successful strategies into a feasible intervention for implementation in rural Tanzania .
-BACKGROUND	Opportunities that can optimise delivery of the intervention and encourage behaviour change include mothers willingness to modifying practices ; support of family members ; seasonal availability and accessibility of foods ; established set-up of village peers and functioning health system .
-BACKGROUND	The primary objective of the study is to evaluate the effectiveness of a nutrition education package in improving feeding practices , dietary adequacy and growth as compared to routine health education .
-METHODS	A parallel cluster randomised controlled trial will be conducted in rural central Tanzania in 9 intervention and 9 control villages .
-METHODS	The control group will receive routine health education offered monthly by health staff at health facilities .
-METHODS	The intervention group will receive a nutrition education package in addition to the routine health education .
-METHODS	The education package is comprised of four components : 1 ) education and counselling of mothers , 2 ) training community-based nutrition counsellors and monthly home visits , 3 ) sensitisation meetings with health staff and family members , and 4 ) supervision of community-based nutrition counsellors .
-METHODS	The duration of the intervention is 9months and infants will be recruited at 6months of age .
-METHODS	Primary outcome ( linear growth as length-for-age Z-scores ) and secondary outcomes ( changes in weight-for-length Z-scores ; mean intake of energy , fat , iron and zinc from complementary foods ; proportion of children consuming 4 or more food groups and recommended number of semi-solid/soft meals and snacks per day ; maternal level of knowledge and performance of recommended practices ) will be assessed at baseline and ages 9 , 12 and 15months .
-METHODS	Process evaluation will document reach , dose and fidelity of the intervention and context at 8 and 15months .
-CONCLUSIONS	Results of the trial will provide evidence of the effectiveness of the nutrition education package in community settings of rural Tanzania .
-CONCLUSIONS	They will provide recommendations for strengthening the nutrition component of health education in child health services .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT02249754 , September 25 , 2014 .
-
-###24615309
-OBJECTIVE	This pilot study aimed to determine whether raw milk reduces lactose malabsorption and/or lactose intolerance symptoms relative to pasteurized milk .
-METHODS	We performed a crossover trial involving 16 adults with self-reported lactose intolerance and lactose malabsorption confirmed by hydrogen ( H2 ) breath testing .
-METHODS	Participants underwent 3 , 8-day milk phases ( raw vs 2 controls : pasteurized , soy ) in randomized order separated by 1-week washout periods .
-METHODS	On days 1 and 8 of each phase , milk consumption was 473 mL ( 16 oz ) ; on days 2 to 7 , milk dosage increased daily by 118 mL ( 4 oz ) , beginning with 118 mL ( 4 oz ) on day 2 and reaching 710 mL ( 24 oz ) on day 7 .
-METHODS	Outcomes were area under the breath H2 curve ( AUC H2 ) and self-reported symptom severity ( visual analog scales : flatulence/gas , audible bowel sounds , abdominal cramping , diarrhea ) .
-RESULTS	AUC H2 ( mean standard error of the mean ) was higher for raw vs pasteurized on day 1 ( 113 21 vs 71 12 ppmmin10 ( -2 ) , respectively , P = .01 ) but not day 8 ( 72 14 vs 74 15 ppmmin10 ( -2 ) , respectively , P = .9 ) .
-RESULTS	Symptom severities were not different for raw vs pasteurized on day 7 with the highest dosage ( P > .7 ) .
-RESULTS	AUC H2 and symptom severities were higher for both dairy milks compared with soy milk .
-CONCLUSIONS	Raw milk failed to reduce lactose malabsorption or lactose intolerance symptoms compared with pasteurized milk among adults positive for lactose malabsorption .
-CONCLUSIONS	These results do not support widespread anecdotal claims that raw milk reduces the symptoms of lactose intolerance .
-
-###25188815
-OBJECTIVE	Nocturnal periodic breathing occurs more frequently in men than in women with various clinical and pathophysiologic conditions .
-OBJECTIVE	The mechanisms accounting for this sex-related difference are not completely understood .
-OBJECTIVE	Acetazolamide effectively counteracts nocturnal periodic breathing , but it has been investigated almost exclusively in men .
-OBJECTIVE	Our aim was to explore possible determinants of nocturnal periodic breathing in a high-altitude setting both in men and in women .
-OBJECTIVE	We hypothesized that increased hypoxic chemosensitivity in men could be associated with the development of nocturnal periodic breathing at altitude more frequently than in women , and that acetazolamide , by leftward shifting the CO2 ventilatory response , could improve nocturnal periodic breathing at altitude in a sex-independent manner .
-METHODS	Forty-four healthy lowlanders ( 21 women ) , randomized to acetazolamide or placebo , underwent cardiorespiratory sleep studies at sea level off treatment and under treatment on the first night after arrival at a 4,559-m altitude .
-METHODS	Hypoxic and hypercapnic chemosensitivities were assessed at sea level .
-RESULTS	Men , more frequently than women , exhibited increased hypoxic chemosensitivity and displayed nocturnal periodic breathing at altitude .
-RESULTS	Acetazolamide leftward shifted the CO2 set point and , at altitude , improved oxygenation and reduced periodic breathing in both sexes , but to a larger extent in men .
-RESULTS	Hypoxic chemosensitivity directly correlated with the number of apneas/hypopneas at altitude in the placebo group but not in the acetazolamide group .
-CONCLUSIONS	The greater severity of periodic breathing during sleep displayed by men at altitude could be attributed to their increased hypoxic chemosensitivity .
-CONCLUSIONS	Acetazolamide counteracted the occurrence of periodic breathing at altitude in both sexes , modifying the apneic threshold and improving oxygenation .
-BACKGROUND	EU Clinical Trials Register , EudraCT ; No. : 2010-019986-27 ; URL : https://www.clinicaltrialsregister.eu .
-
-###24585164
-BACKGROUND	Use of an arterial catheter to obtain hourly blood samples for intensive insulin therapy monitoring avoids causing patients the discomfort of repeated fingersticks .
-BACKGROUND	Returning the clearing volume may decrease procedure-related blood loss by 50 % and minimize the risk of anemia .
-OBJECTIVE	To compare the feasibility of 2 arterial catheter clearing-volume return setups for hourly blood extractions and to evaluate the related complications and the accuracy of arterial samples in determining glycemia .
-METHODS	In an open clinical trial , 90 critical patients undergoing intensive insulin therapy who had a radial arterial catheter were randomized to an intervention group-nonwaste needleless setup or nonwaste syringe setup and compared with the standard setup ( control group ) .
-METHODS	Mechanical and infectious complications related to the arterial catheter were evaluated .
-METHODS	Blood glucose measurements at point-of-care glucometer ( arterial catheter or fingerstick sample ) were compared with laboratory results ( venous blood ) .
-RESULTS	No patient had catheter-related infection in the intervention group ( an estimated 12776 manipulations ) ; the control group had 2 infection episodes in 5230 catheter-days ( an estimated 13 075 manipulations ) .
-RESULTS	The incidence of bacterial colonization was not significantly higher in the needleless group than in the syringe group ( 22.2 % vs 12.2 % ; relative risk , 0.55 ; 95 % CI , 0.16-1 .71 ) , with 1778 ( SD , 114 ) and 1918 ( SD , 82 ) catheter manipulations , respectively .
-RESULTS	Arterial catheter complications were negligible in all patients .
-RESULTS	Glycemia was detected from arterial catheter samples as effectively as with laboratory results ( venous samples ) except when hematocrit was less than 25 % .
-CONCLUSIONS	Use of blood obtained via an arterial catheter is safe and effective for glucose monitoring in patients undergoing intensive insulin therapy , with no increase in complications of catheterization .
-
-###24240351
-OBJECTIVE	Caffeine , probably the most widely consumed psychoactive substance , is claimed to have conflicting effects on some tear film dynamics .
-OBJECTIVE	This study sought to investigate the effect of orally ingested caffeine on tear secretion .
-METHODS	In an examiner-masked , placebo-controlled , crossover experimental model , the effect of caffeine intake on tear secretion was studied in 41 healthy volunteers aged 20 to 26 years ( mean , 23.0 2.1 years ) .
-METHODS	Participants were randomly assigned into two groups , A and B , to receive two different treatments in two sessions .
-METHODS	Subjects in group A were exposed to 5.0 mg/kg body weight of caffeine dissolved in 200 mL of water on their first visit , whereas those in group B were exposed to 200 mL of water .
-METHODS	On the second visit , however , the order of treatment was reversed .
-METHODS	Schirmer 1 scores were measured repeatedly at 45 , 90 , 135 , and 180 minutes after treatment .
-METHODS	The baseline Schirmer 1 scores were compared with posttreatment scores .
-RESULTS	Schirmer 1 scores increased after caffeine intake .
-RESULTS	The increase was statistically significant at 45 and 90 minutes ( p < 0.05 ) after caffeine intake .
-RESULTS	Age , body mass , and blood pressure had no correlation with Schirmer 1 scores ( Spearman correlation test , p > 0.05 ) .
-RESULTS	There was no influence of gender in caffeine 's effect on tear secretion ( F = 0.994 , p = 0.399 ) .
-CONCLUSIONS	From our study , orally ingested caffeine appears to stimulate tear secretion in healthy non-dry eye subjects .
-
-###24898101
-BACKGROUND	Biliary decompression with antibiotic therapy is the mainstay treatment for acute cholangitis with bacteremia .
-BACKGROUND	A few studies have been conducted to investigate the optimal duration and route of antibiotic therapy in biliary tract infection with bacteremia .
-METHODS	Patients with acute cholangitis with bacteremia who achieved successful biliary drainage were randomly assigned to an early oral antibiotic switch group ( group A , n = 29 ) and a conventional intravenous antibiotics group ( group B , n = 30 ) .
-METHODS	Patients were discharged when they were afebrile over 2days after oral antibiotic switch and showed consecutive improvement in the laboratory index .
-METHODS	They were followed up and assessed at 30days after diagnosis to evaluate the eradication of bacteria , recurrence of acute cholangitis , and 30-day mortality rate .
-RESULTS	There were no statistically significant differences between the two groups in baseline characteristics , clinical and laboratory index , severity of acute cholangitis , bacteria isolated from blood cultures , and clinical outcomes .
-RESULTS	The rate of eradication of bacteria was 93.1 % in group A and 93.3 % in group B , respectively ( p = 0.97 ) .
-RESULTS	Using non-inferiority tests , the rate of eradication of bacteria in group A was not inferior to that in group B ( 95 % CI -0.13 to 0.14 , p = 0.97 ) .
-RESULTS	There was no statistically significant difference in the recurrence of acute cholangitis and a 30-day mortality rate between the two groups .
-CONCLUSIONS	Early switch to oral antibiotic therapy following adequate biliary drainage for treatment of acute cholangitis with bacteremia was not inferior to conventional 10-day intravenous antibiotic therapy .
-
-###25336623
-BACKGROUND	The benefit of the combination of serum galactomannan ( GM ) assay and polymerase chain reaction ( PCR ) - based detection of serum Aspergillus DNA for the early diagnosis and therapy of invasive aspergillosis ( IA ) in high-risk hematological patients remains unclear .
-METHODS	We performed an open-label , controlled , parallel-group randomized trial in 13 Spanish centers .
-METHODS	Adult patients with acute myeloid leukemia and myelodysplastic syndrome on induction therapy or allogeneic hematopoietic stem cell transplant recipients were randomized ( 1:1 ratio ) to 1 of 2 arms : `` GM-PCR group '' ( the results of serial serum GM and PCR assays were provided to treating physicians ) and `` GM group '' ( only the results of serum GM were informed ) .
-METHODS	Positivity in either assay prompted thoracic computed tomography scan and initiation of antifungal therapy .
-METHODS	No antimold prophylaxis was permitted .
-RESULTS	Overall , 219 patients underwent randomization ( 105 in the GM-PCR group and 114 in the GM group ) .
-RESULTS	The cumulative incidence of `` proven '' or `` probable '' IA ( primary study outcome ) was lower in the GM-PCR group ( 4.2 % vs 13.1 % ; odds ratio , 0.29 [ 95 % confidence interval , .09 -.91 ] ) .
-RESULTS	The median interval from the start of monitoring to the diagnosis of IA was lower in the GM-PCR group ( 13 vs 20 days ; P = .022 ) , as well as the use of empirical antifungal therapy ( 16.7 % vs 29.0 % ; P = .038 ) .
-RESULTS	Patients in the GM-PCR group had higher proven or probable IA-free survival ( P = .027 ) .
-CONCLUSIONS	A combined monitoring strategy based on serum GM and Aspergillus DNA was associated with an earlier diagnosis and a lower incidence of IA in high-risk hematological patients .
-CONCLUSIONS	Clinical Trials Registration.NCT01742026 .
-
-###24231013
-OBJECTIVE	To evaluate the benefits of reducing insulin resistance by early enteral nutrition ( EEN ) in gastric cancer patients after surgery .
-METHODS	Gastric cancer patients were managed to randomly accept traditional total parenteral nutrition ( group A ) or EEN ( group B ) after surgical treatment .
-METHODS	The patients in group B were fed by tubes with 250-500 mL 5 % sodium chloride and glucose injection at 24 h post-surgery , and were fed enteral nutritional emulsion with constant infusion by pump slowly increasing from 20 mL/h to 100 mL/h from 48 h , and then transiting to total enteral nutrition .
-METHODS	Insulin sensitivity of patients was detected by Quicki method before operation and at 24 h , 48 h , 72 h , 120 h and 168 h post-surgery .
-RESULTS	A total of 77 patients were enrolled , with 42 patients in group A , and 35 patients in group B. Baseline characteristics , biochemical indexes and operational characteristics were well balanced between two groups .
-RESULTS	The time-insulin sensitivity curves of the two groups indicated that IR was present early ( day 1 to day 7 ) in gastric cancer patients and was significantly different between patients who had undergone surgical treatment and those who had not .
-RESULTS	Insulin sensitivity ( SI ) of patients in group B were higher than patients in group A with adjusting BMI , age and SI preoperative at 72 h , 120 h and 168 h post-surgery .
-CONCLUSIONS	The management of EEN can alleviate insulin resistance in gastric cancer patients with surgical treatment .
-
-###25873601
-OBJECTIVE	Acupuncture is a frequently used complementary treatment for ischemic stroke in China but the evidence available from previous randomized trials is inconclusive .
-OBJECTIVE	The objective of this study was to assess the efficacy and safety of acupuncture in a more robustly designed larger scale trial .
-METHODS	This is a multicenter , single-blinded , randomized controlled trial .
-METHODS	Eight hundred sixty-two hospitalized patients with limb paralysis between 3 to 10 days after ischemic stroke onset were allocated acupuncture plus standard care or standard care alone .
-METHODS	The acupuncture was applied 5 times per week for 3 to 4 weeks .
-METHODS	The primary outcomes were defined as follows : ( 1 ) death/disability according to Barthel index and ( 2 ) death/institutional care at 6 months .
-RESULTS	There was a tendency of fewer patients being dead or dependent in acupuncture group ( 80/385 , 20.7 % ) than in control group ( 102/396 , 25.8 % ) at 6 months ( odds ratio , 0.75 ; 95 % confidence interval , 0.54-1 .05 ) .
-RESULTS	The benefit was noted in subgroup receiving 10 sessions of acupuncture ( odds ratio , 0.68 ; 95 % confidence interval , 0.47-0 .98 ) .
-RESULTS	There was no statistical difference in death or institutional care between the 2 groups ( odds ratio , 1.06 ; 95 % confidence interval , 0.63-1 .79 ) .
-RESULTS	Severe adverse events occurred in 7.6 % and 8.3 % of patients in the 2 groups , respectively .
-CONCLUSIONS	Acupuncture seemed to be safe in the subacute phase of ischemic stroke .
-CONCLUSIONS	If the potential benefits observed are confirmed in future larger study , the health gain from wider use of the treatment could be substantial .
-BACKGROUND	URL : http://www.chictr.org/en/ .
-BACKGROUND	Unique identifier : ChiCTR-TRC-11001353 .
-
-###25837839
-BACKGROUND	Biosimilars provide safety , purity , and potency similar to those of a reference biologic product .
-METHODS	An array of protein analytical techniques was used to compare the physicochemical properties of proposed biosimilar filgrastim ( EP2006 ) , US-approved originator filgrastim , and EU-approved originator filgrastim .
-METHODS	Biological characterization involved surface plasmon resonance spectroscopy analyses and in vitro proliferation assays .
-METHODS	A randomized , double-blind , two-way crossover , phase I study in healthy volunteers assessed the pharmacodynamics , pharmacokinetics , and safety profiles of EP2006 and US-approved originator filgrastim ( administered as a single subcutaneous 10 g/kg injection ) .
-RESULTS	EP2006 and originator filgrastim ( US and EU approved ) were highly similar with respect to primary , secondary , and tertiary protein structures ; mass , size , purity , charge , and hydrophobicity .
-RESULTS	No differences in receptor binding affinity were observed , and all samples demonstrated similar in vitro bioactivity .
-RESULTS	In the phase I study , no statistically significant differences between EP2006 and US-approved originator filgrastim were noted in pharmacodynamic or pharmacokinetic parameters , and all confidence intervals were within the equivalence boundaries .
-RESULTS	The two products had similar safety profiles .
-CONCLUSIONS	These studies provide robust evidence of the structural and functional similarity between the proposed biosimilar filgrastim ( EP2006 ) and the US-approved originator filgrastim .
-
-###24854458
-BACKGROUND	Elevated serum phosphorus and FGF23 are independent cardiovascular risk factors in patients with chronic kidney disease .
-BACKGROUND	In a randomized controlled trial of patients with dyslipidemia assigned to either extended release niacin ( ERN ) alone , ERN combined with the selective prostaglandin D2 receptor subtype 1 inhibitor laropiprant ( ERN-L ) or placebo , niacin lowered serum phosphorus ; however , it is not known if it lowers FGF23 concentrations .
-METHODS	This is an ancillary study to a multicenter , randomized , double-blind , placebo-controlled trial among patients with dyslipidemia and an estimated glomerular filtration rate ( eGFR ) of 30-74 ml/min/1 .73 m ( 2 ) .
-METHODS	Participants were randomized to ERN-L ( n = 162 ) , ERN ( n = 97 ) , or placebo ( n = 68 ) in a 3:2:1 ratio for 24 weeks .
-METHODS	The primary outcome was a change in serum FGF23 concentrations , and secondary outcomes were changes in other mineral metabolism parameters .
-RESULTS	Both the ERN and ERN-L groups showed significant declines in serum phosphorus , calcium and calciumphosphorus product at 24 weeks compared to placebo .
-RESULTS	A significant decline from baseline ( 10.9 % , p < 0.01 ) in the serum FGF23 concentration was observed in the ERN group compared to placebo , but not in the ERN-L group compared to placebo ( p = 0.36 and 0.97 for ERN-L and placebo , respectively ) , despite equivalent declines in serum phosphorus .
-RESULTS	Similarly , the most marked declines in PTH occurred in the ERN-only group versus placebo ; no change in PTH was observed in the ERN-L group .
-CONCLUSIONS	In this ancillary study of hyperlipidemic patients with an eGFR of 30-74 ml/min/1 .73 m ( 2 ) , ERN alone but not in combination with laropiprant lowered FGF23 and PTH concentrations .
-CONCLUSIONS	If confirmed , niacin may provide a novel strategy to decrease phosphorus , FGF23 , and PTH concentrations in patients with chronic kidney disease .
-
-###26237827
-OBJECTIVE	To study the efficacy and safety of combined Traditional Chinese Medicine ( TCM ) therapy based on nourishing marrow to improve intellect and reinforcing Qi to activate bloodon mild to moderate Alzheimer 's disease ( AD ) .
-METHODS	Sixty-six patients with AD , whose Mini-Mental State Examination ( MMSE ) score were from 10-24 , were randomized equally into an intervention group and a control group .
-METHODS	The control group was given Aricept ( 5 mg , once daily ) .
-METHODS	The intervention group was further divided into Yang-Qi deficiency ( n = 18 ) and of Yin-Qi deficiency ( n = 15 ) subgroups .
-METHODS	Patients in the Yang-Qi deficiency group were intravenously administered shenfu injection , 60 mL , and deproteinized calf blood injection ( DCBI ) , 1.2 g , once daily .
-METHODS	The Yin-Qi deficiency group was given shenmai injection , 60 mL , and DCBI , 1.2 g , once daily .
-METHODS	Each course lasted 21 days .
-RESULTS	Compared with the control group and with pre-treatment in the same group , MMSE , clinical dementia rating , and activities of daily living scale scores in the intervention group were significantly improved ( all P < 0.05 ) .
-RESULTS	These metrics mildly improved in the control group compared with before treatment ( P > 0.05 ) .
-RESULTS	No adverse effects were observed in any group during treatment .
-CONCLUSIONS	We found that combined TCM therapy is effective and safe for managing mild to moderate AD .
-
-###25441170
-BACKGROUND	Chronic post-traumatic headache ( CPTH ) after mild head injury can be difficult to manage .
-BACKGROUND	Research is scarce and successful interventions are lacking.To evaluate the effect of a group-based Cognitive Behavioural Therapy ( CBT ) intervention in relation to headache , pain perception , psychological symptoms and quality of life in patients with CPTH .
-METHODS	Ninety patients with CPTH according to ICHD-2 criteria were enrolled from the Danish Headache Center into a randomized , controlled trial .
-METHODS	Patients were randomly assigned to either a waiting list group or to a nine-week CBT group intervention .
-METHODS	At baseline and after 26weeks all patients completed the Rivermead Post Concussion Symptoms Questionnaire , SF-36 , SCL-90-R and a headache diary .
-RESULTS	The CBT had no effect on headache and pressure pain thresholds and only a minor impact on the CPTH patients ' quality of life , psychological distress , and the overall experience of symptoms .
-RESULTS	The waiting-list group experienced no change in headache but , opposed to the treatment group , a significant decrease in somatic and cognitive symptoms indicating a spontaneous remission over time .
-CONCLUSIONS	Our primarily negative findings confirm that management of patients with CPTH still remains a considerable challenge .
-CONCLUSIONS	Psychological group therapy with CBT might be effective in an earlier stage of CPTH and in less severely affected patients but our findings strongly underline the need for randomized controlled studies to test the efficacy of psychological therapy .
-
-###24257388
-BACKGROUND	Distraction technology suitable for the perioperative setting is readily available , but there is little evidence to show how it compares with oral midazolam in managing anxiety .
-BACKGROUND	Video glasses , which enable children to view and listen to cartoons and movies , may be used through the completion of inhaled induction .
-BACKGROUND	We compared the efficacy of oral midazolam and behavioral distraction with video glasses in managing preoperative anxiety in children .
-METHODS	In this prospective , randomized study , 96 children aged 4 to 9 years undergoing outpatient surgery were recruited to one of 3 intervention groups receiving midazolam , video glasses , or both .
-METHODS	The Modified Yale Preoperative Anxiety Scale was the primary dependent measure used to assess anxiety at baseline before intervention , 20 minutes later at transport to the operating room ( OR ) , and during mask induction .
-RESULTS	There was no significant increase in anxiety score within any group between baseline and OR transport ( P = 0.21 , 0.42 , and 0.57 for midazolam , video glasses , and combined groups , respectively ) .
-RESULTS	An increase in anxiety , though not large enough to be clinically significant , was observed from baseline to induction in the midazolam and combined groups ( P = 0.02 and 0.03 ) but not in the video glasses group ( P = 0.38 ) .
-RESULTS	Confidence intervals for pairwise comparisons in Modified Yale Preoperative Anxiety Scale changes among groups were all within a clinically significant difference of 15 units .
-CONCLUSIONS	The use of video glasses and midazolam alone or in combination maintains baseline levels of anxiety at time of transport to the OR and prevents significantly increased anxiety during induction of anesthesia in children .
-CONCLUSIONS	Video glasses are not inferior to midazolam for preoperative anxiolysis and provide a safe , noninvasive , nonpharmacologic , and pleasant alternative .
-
-###24228683
-OBJECTIVE	We examined the impact of school water , sanitation , and hygiene ( WASH ) interventions on diarrhea-related outcomes among younger siblings of school-going children .
-METHODS	We conducted a cluster-randomized trial among 185 schools in Kenya from 2007 to 2009 .
-METHODS	We assigned schools to 1 of 2 study groups according to water availability .
-METHODS	Multilevel logistic regression models , adjusted for baseline measures , assessed differences between intervention and control arms in 1-week period prevalence of diarrhea and 2-week period prevalence of clinic visits among children younger than 5 years with at least 1 sibling attending a program school .
-RESULTS	Among water-scarce schools , comprehensive WASH improvements were associated with decreased odds of diarrhea ( odds ratio [ OR ] = 0.44 ; 95 % confidence interval [ CI ] = 0.27 , 0.73 ) and visiting a clinic ( OR = 0.36 ; 95 % CI = 0.19 , 0.68 ) , relative to control schools .
-RESULTS	In our separate study group of schools with greater water availability , school hygiene promotion and water treatment interventions and school sanitation improvements were not associated with differences in diarrhea prevalence between intervention and control schools .
-CONCLUSIONS	In water-scarce areas , school WASH interventions that include robust water supply improvements can reduce diarrheal diseases among young children .
-
-###24606886
-BACKGROUND	Fluralaner is a novel systemic insecticide and acaricide that provides long acting efficacy in dogs after a single oral treatment .
-BACKGROUND	This study investigated the safety of oral administration of fluralaner in chewable tablets to dogs at the highest recommended treatment dose and at multiples of this dose .
-METHODS	Thirty-two ( 16 male and 16 female ) healthy 8-week old Beagle dogs weighing 2.0 - 3.6 kg at first administration were included in the study .
-METHODS	Fluralaner was administered on three occasions at 8-week intervals at doses of up to 56 , 168 , and 280 mg fluralaner/kg body weight , equivalent to 1 , 3 , and 5 times the highest recommended treatment dose of fluralaner ; sham dosed dogs served as controls.During the study , all dogs were clinically observed , and their health was carefully monitored including body weight development , food consumption and measurement of hematology , coagulation , clinical chemistry ( including measurement of levels of ACTH and C-reactive protein ) and urinalysis .
-METHODS	Following euthanasia of the dogs , complete gross post mortem examination , including organ weight determination , and histopathological examination of multiple tissues were conducted .
-RESULTS	There were no clinical findings related to fluralaner treatment .
-RESULTS	Statistically significant differences between the treated groups and the control group were observed for some clinical pathology parameters and organ weights ; none of these findings were considered to be of clinical relevance .
-CONCLUSIONS	Oral administration of fluralaner at the highest recommended treatment dose ( 56 mg/kg ) at 8-week intervals is well tolerated and has a safety margin of more than five in healthy dogs eight weeks of age or older and weighing at least 2 kg .
-
-###25244260
-OBJECTIVE	Despite the significant positive effect of Highly Active Antiretroviral Therapy on physical and psychosocial well-being of people living with human immunodeficiency virus/acquired immune deficiency syndrome ( HIV/AIDS ) ( PLWHA ) ; decreased physical activity and its associated cardiovascular risk still pose some consequences for health and general well-being .
-OBJECTIVE	This study investigated the effect of an 8 week aerobic exercise training on cardiovascular parameters and CD4 cell ( T-cells ) count of PLWHA .
-METHODS	This randomized controlled trial recruited 30 age matched PLWHA who were randomly assigned into exercise group ( EG ) ( n = 15 ) and control group ( CG ) ( n = 15 ) respectively .
-METHODS	The PLWHA were patients receiving treatment in President 's Emergency Plan for AIDS relief at the HIV clinic of the University of Nigeria Teaching Hospital , Nigeria .
-METHODS	The EG in addition to conventional therapy received moderate intensity continuous exercise training ( 60-79 % of the maximum heart rate [ max ] ) of between 45 and 60 min , 3 times/week for 8 weeks , while the CG received conventional therapy involving antiretroviral therapy and counseling only .
-METHODS	Systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , maximum oxygen uptake ( VO max ) and CD4 cell count were assessed at baseline ( week 1 ) and week 8 respectively .
-METHODS	Analysis of co-variance and Pearson correlation tests were used in data analysis .
-RESULTS	Findings of the study revealed a significant effect ( ANCOVA test ) of moderate intensity continuous exercise training program on , SBP , DBP , VO max and CD4 cell count at P < 0.05 .
-RESULTS	Changes in VO max significantly correlated ( Pearson correlation test ) with changes in CD4 cell count ( r = 0.528 ) at P < 0.05 .
-CONCLUSIONS	Moderate intensity aerobic exercise is an effective complementary therapy in lowering blood pressure and increasing CD4 cell count in PLWHA .
-
-###25390871
-OBJECTIVE	The aim of this study was to investigate whether an acrylic resin-based resilient liner ( ARL ) could improve the satisfaction ratings of complete denture wearers .
-OBJECTIVE	The null hypothesis was that no difference exists between the satisfaction ratings of conventional acrylic resin denture ( CARD ) wearers and those of ARL denture ( ARLD ) wearers .
-METHODS	From April 2004 to July 2006 , a randomized controlled trial was conducted at two centers , including 74 edentulous patients .
-METHODS	Of these , 37 patients were each randomly allocated to the ARLD and CARD groups .
-METHODS	All of the patients rated their satisfaction with dentures , including general satisfaction and satisfaction with chewing ability , speaking , cleaning , stability , retention , comfort , and esthetics .
-METHODS	These satisfaction ratings were measured by a 100-mm visual analog scale .
-METHODS	Perceived chewing ability of different foods , divided into five grades , was measured using a questionnaire .
-METHODS	The mastication index ( MI ) was calculated for each grade .
-RESULTS	General satisfaction , satisfaction with chewing , and satisfaction with speaking were significantly higher in the ARLD than in the CARD group ( P = .049 , .025 , and .049 , respectively ) .
-RESULTS	The chewing satisfaction with maxillary dentures in the ARLD group was significantly higher than that of the CARD group ( P = .02 ) .
-RESULTS	No significant difference existed between the MI of the ARLD ( 69.2 17.0 ) and CARD groups ( 66.7 18.7 ) .
-CONCLUSIONS	Within its limitations , this study showed that the ARL improves a complete denture wearer 's satisfaction ratings .
-
-###25245464
-BACKGROUND	Digital rectal examination is an essential tool in the evaluation of the rectum .
-BACKGROUND	The aim of this trial was to determine the best position for performing a digital rectal examination .
-METHODS	A total of 321 patients were randomized into `` dorsal '' or `` lateral '' groups in this multicentre randomized controlled trial performed in an outpatient setting .
-METHODS	The primary endpoint was the proportion of patients with a complete digital rectal examination , defined as the examination of the rectum ( upper border of the prostate ) , the entire circumference , and the assessment of the sphincter tone .
-RESULTS	The dorsal group included a total of 161 patients ( mean age : 62.3 13.04 years ) , while the lateral group included 160 patients ( mean age : 62.7 14.4 years ) .
-RESULTS	The proportion of patients with a complete digital rectal examination was 44 % ( n = 71 ) in the dorsal group and 49 % ( n = 79 ) in the lateral group ( p = 0.3 ) .
-RESULTS	The entire circumference of the rectum could be examined in 66 % of the patients ( n = 106 ) in the dorsal group and in 79.5 % of the patients ( n = 128 ) in the lateral group ( p = 0.007 ) .
-CONCLUSIONS	The intergroup difference in terms of digital rectal examination completion rate was not significant .
-CONCLUSIONS	In the lateral position , however , the entire circumference of the rectum could be examined more thoroughly .
-
-###24700398
-BACKGROUND	This large prospective , randomized study was designed to compare the `` mild '' protocol with clomiphene citrate , low-dose gonadotropins and a GnRH-antagonist ( CC/Gn/GnRH-ant protocol ) with the `` long '' protocol with a GnRH-agonist and high-dose Gn for the controlled ovarian hyperstimulation ( COH ) of patients with expected poor ovarian responsiveness undergoing IVF .
-METHODS	A total of 695 women with clinical , endocrine and ultrasound characteristics suggesting a low ovarian reserve and a poor responsiveness to COH were recruited and randomly assigned to receive the CC/Gn/GnRH-ant `` mild '' protocol ( mild group , n = 355 ) or the `` long '' protocol with high-dose Gn ( long group , n = 340 ) .
-RESULTS	The `` mild '' stimulation led to significantly shorter follicular phase , lower consumption of exogenous Gn and lower peak estradiol level than the `` long '' regimen .
-RESULTS	With the `` long '' protocol , significantly less cycles were cancelled due to the lack of ovarian response ; further , it obtained significantly more oocytes , more mature oocytes , more embryos , and a thicker endometrium .
-RESULTS	As for the final IVF outcome , however , the two stimulation regimens obtained comparable implantation rate , clinical pregnancy rate , and ongoing pregnancy rate at 12 weeks .
-CONCLUSIONS	In conclusion , the `` mild '' CC/Gn/GnRH-ant stimulation protocol is a valid alternative to the long protocol with high Gn dose as it obtains a comparable success rate and requires significantly less medications , with an obvious economical advantage .
-
-###24973289
-OBJECTIVE	To compare oxygen saturations as displayed to caregivers on offset pulse oximeters in the 2 groups of the Canadian Oxygen Trial .
-METHODS	In 5 double-blind randomized trials of oxygen saturation targeting , displayed saturations between 88 % and 92 % were offset by 3 % above or below the true values but returned to true values below 84 % and above 96 % .
-METHODS	During the transition , displayed values remained static at 96 % in the lower and at 84 % in the higher target group during a 3 % change in true saturations .
-METHODS	In contrast , displayed values changed rapidly from 88 % to 84 % in the lower and from 92 % to 96 % in the higher target group during a 1 % change in true saturations .
-METHODS	We plotted the distributions of median displayed saturations on days with > 12hours of supplemental oxygen in 1075 Canadian Oxygen Trial participants to reconstruct what caregivers observed at the bedside .
-RESULTS	The oximeter masking algorithm was associated with an increase in both stability and instability of displayed saturations that occurred during the transition between offset and true displayed values at opposite ends of the 2 target ranges .
-RESULTS	Caregivers maintained saturations at lower displayed values in the higher than in the lower target group .
-RESULTS	This differential management reduced the separation between the median true saturations in the 2groups by approximately 3.5 % .
-CONCLUSIONS	The design of the oximeter masking algorithm may have contributed to the smaller-than-expected separation between true saturations in the 2 study groups of recent saturation targeting trials in extremely preterm infants .
-
-###24229753
-BACKGROUND	Gender differences exist in psychiatric disorders ; however , gender has not been well studied in psychotic depression .
-BACKGROUND	This analysis of the largest clinical trial in psychotic depression examined the effects of age and gender on clinical characteristics and predictors of treatment outcome and treatment-associated changes in body mass index ( BMI ) and metabolic measures .
-METHODS	Secondary analyses were performed on data from 259 subjects with major depressive disorder with psychotic features ( DSM-IV-TR ) aged 18-93 years in the double-blind randomized controlled trial of olanzapine plus sertraline versus olanzapine plus placebo for psychotic depression ( Study of Pharmacotherapy of Psychotic Depression ) .
-METHODS	Sociodemographic factors , clinical characteristics , treatment outcome , and treatment-associated changes in BMI and metabolic measures were analyzed by gender and age .
-METHODS	Subjects were enrolled from December 2002 to June 2007 .
-RESULTS	Female gender was associated with divorced ( ( 2 ) ( 1 ) = 5.3 , P = .03 ) or widowed ( ( 2 ) ( 1 ) = 8.1 , P .01 ) marital status .
-RESULTS	Comorbid anxiety disorders were more common in women than in men ( ( 2 ) ( 1 ) = 4.9 , P = .03 ) .
-RESULTS	Hallucinations ( ( 2 ) ( 1 ) = 7.8 , P = .005 ) and delusions with disorganization ( t ( 257 ) = -2.10 , P = .04 ) were significantly associated with female gender , as were higher cholesterol measures ( ( 2 ) ( 1 ) = 7.15 , P = .008 ) .
-RESULTS	There were no significant interactions between treatment and gender in terms of change in BMI .
-RESULTS	Gender was not associated with treatment response .
-CONCLUSIONS	This study is the first analysis of gender and age as predictors of treatment outcome and treatment-associated changes in BMI and metabolic adverse effects in psychotic depression .
-CONCLUSIONS	Gender differences exist in patients with psychotic depression , most notably with regard to the presence of hallucinations .
-CONCLUSIONS	Female gender was associated with metabolic measures .
-CONCLUSIONS	Future studies with larger sample sizes may detect small gender differences in treatment outcome and treatment-associated changes in BMI and metabolic measures in psychotic depression .
-BACKGROUND	ClinicalTrials.gov identifier : NCT00056472 .
-
-###26422724
-BACKGROUND	The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes .
-METHODS	We conducted a double-blind , parallel , randomized clinical trial between June 2013 and July 2014 at 10 sites .
-METHODS	Eligibility criteria included an age of 18 years or older , smoking of five or more cigarettes per day , and no current interest in quitting smoking .
-METHODS	Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes , provided free .
-METHODS	The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco ( typical of commercial brands ) to 0.4 mg per gram .
-METHODS	The primary outcome was the number of cigarettes smoked per day during week 6 .
-RESULTS	A total of 840 participants underwent randomization , and 780 completed the 6-week study .
-RESULTS	During week 6 , the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4 , 1.3 , or 0.4 mg of nicotine per gram of tobacco ( 16.5 , 16.3 , and 14.9 cigarettes , respectively ) than for participants randomly assigned to their usual brand or to cigarettes containing 15.8 mg per gram ( 22.2 and 21.3 cigarettes , respectively ; P < 0.001 ) .
-RESULTS	Participants assigned to cigarettes with 5.2 mg per gram smoked an average of 20.8 cigarettes per day , which did not differ significantly from the average number among those who smoked control cigarettes .
-RESULTS	Cigarettes with lower nicotine content , as compared with control cigarettes , reduced exposure to and dependence on nicotine , as well as craving during abstinence from smoking , without significantly increasing the expired carbon monoxide level or total puff volume , suggesting minimal compensation .
-RESULTS	Adverse events were generally mild and similar among groups .
-CONCLUSIONS	In this 6-week study , reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked .
-CONCLUSIONS	( Funded by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products ; ClinicalTrials.gov number , NCT01681875 . )
-
-###24411508
-BACKGROUND	As of 2011 , over 9 million working-age adults were receiving federal disability benefits and this number is expected to rise steadily .
-BACKGROUND	Early intervention programs that seek to maintain employment and forestall the receipt of federal disability benefits offer a promising strategy to reduce the growing number of working-age adults on the disability rolls .
-OBJECTIVE	Using random assignment , this study examined whether an early intervention program of personal navigators , enhanced medical care , and employment supports can reduce dependence on federal disability benefits for adult workers with mental health conditions .
-METHODS	The study reports multivariate and descriptive findings based on 2279 participants in the Demonstration to Maintain Independence and Employment ( DMIE ) .
-METHODS	Logistic regression analysis was used to estimate program impacts in the treatment group relative to the control group .
-METHODS	Data were integrated from state participant surveys and the SSA Ticket Research File .
-RESULTS	The DMIE intervention significantly reduced the percent of participants who received disability benefits after 12 months of enrollment .
-RESULTS	Across both states , the difference between the treatment group and control group was 1.1 percentage points ( 2.5 % versus 3.6 % , p < 0.01 ) .
-RESULTS	In Texas , the difference was 1.2 percentage points ( 3.2 % versus 4.4 % , p < 0.01 ) .
-CONCLUSIONS	Early intervention programs with a personal navigator can reduce dependence on federal disability benefits for adult workers with mental health conditions .
-CONCLUSIONS	Future studies on the cost-effectiveness of such programs are needed .
-
-###24497338
-OBJECTIVE	Although catheter ablation ( CA ) has replaced antiarrhythmic drugs ( AAD ) as first-line treatment in selected patients with atrial fibrillation ( AF ) , optimal treatment of recurrent atrial tachycardia ( AT ) after AF ablation remains unclear .
-OBJECTIVE	This parallel randomized controlled study compared CA vs. AAD for recurrent AT after persistent AF ablation .
-RESULTS	Two-hundred and one patients ( aged 59.1 10.9 years , 68.7 % male ) with recurrent AT after persistent AF ablation were enrolled and randomized to either CA ( n = 101 ) or AAD ( n = 100 ) treatment .
-RESULTS	Primary endpoint was freedom from recurrent atrial tachyarrhythmia ( ATa , including AT and AF ) at 24-month follow-up .
-RESULTS	Composite secondary endpoints comprised procedural complications , long-term morbidity and improvement in quality of life ( QoL ) .
-RESULTS	On an intention-to-treat basis , the CA group had a higher rate of freedom from recurrent ATa ( 56.4 vs. 34.0 % ; P = 0.001 ) .
-RESULTS	Adjusted Cox regression analysis showed a significant treatment effect with a hazard ratio of 0.538 ( 95 % CI : 0.355-0 .816 ) in favour of CA .
-RESULTS	There was a higher proportion of periprocedural complications in the CA group ( 7.9 vs. 0 ; P = 0.012 ) , and of long-term adverse events in the AAD group ( 10.9 vs. 24.0 % ; P = 0.014 ) .
-RESULTS	Quality of life was significantly higher for CA .
-CONCLUSIONS	This study demonstrates superiority of CA over AAD for recurrent AT after persistent AF ablation with regard to SR maintenance , long-term safety and QoL improvement .
-CONCLUSIONS	However , CA use might be limited by a higher risk for periprocedural complications .
-
-###24602342
-BACKGROUND	Fluralaner is a novel systemic ectoparasiticide for dogs providing long-acting flea - and tick-control after a single oral dose .
-BACKGROUND	This study investigated the safety of oral administration of fluralaner at 3 times the highest expected clinical dose to Multi Drug Resistance Protein 1 ( MDR1 ( - / - ) ) gene defect Collies .
-METHODS	Sixteen Collies homozygous for the MDR1 deletion mutation were included in the study .
-METHODS	Eight Collies received fluralaner chewable tablets once at a dose of 168 mg/kg ; eight sham dosed Collies served as controls .
-METHODS	All Collies were clinically observed until 28 days following treatment .
-RESULTS	No adverse events were observed subsequent to fluralaner treatment of MDR1 ( - / - ) Collies at three times the highest expected clinical dose .
-CONCLUSIONS	Fluralaner chewable tablets are well tolerated in MDR1 ( - / - ) Collies following oral administration .
-
-###25280869
-BACKGROUND	Many people with clinically significant chronic obstructive pulmonary disease ( COPD ) remain undiagnosed worldwide .
-BACKGROUND	There are a number of small studies which have examined possible methods of case finding through primary care , but no large RCTs that have adequately assessed the most cost-effective approach .
-METHODS	In this study , using a cluster randomised controlled trial ( RCT ) in 56 general practices in the West Midlands , we plan to investigate the effectiveness and cost-effectiveness of a Targeted approach to case finding for COPD compared with routine practice .
-METHODS	Using an individual patient RCT nested in the Targeted arm , we plan also to compare the effectiveness and cost-effectiveness of Active case finding using a postal questionnaire ( with supplementary opportunistic questionnaires ) , and Opportunistic-only case finding during routine surgery consultations.All ever-smoking patients aged 40-79 years , without a current diagnosis of COPD and registered with participating practices will be eligible .
-METHODS	Patients in the Targeted arm who report positive respiratory symptoms ( chronic cough or phlegm , wheeze or dyspnoea ) using a brief questionnaire will be invited for further spirometric assessment to ascertain whether they have COPD or not .
-METHODS	Post-bronchodilator spirometry will be conducted to ATS standards using an Easy One spirometer by trained research assistants.The primary outcomes will be new cases of COPD and cost per new case identified , comparing targeted case finding with routine care , and two types of targeted case finding ( active versus opportunistic ) .
-METHODS	A multilevel logistic regression model will be used to model the probability of detecting a new case of COPD for each treatment arm , with clustering of patients ( by practice and household ) accounted for using a multi-level structure.A trial-based analysis will be undertaken using costs and outcomes collected during the trial .
-METHODS	Secondary outcomes include the feasibility , efficiency , long-term cost-effectiveness , patient and primary care staff views of each approach .
-CONCLUSIONS	This will be the largest RCT of its kind , and should inform how best to identify undiagnosed patients with COPD in the UK and other similar healthcare systems .
-CONCLUSIONS	Sensitivity analyses will help local policy-makers decide which sub-groups of the population to target first .
-BACKGROUND	Current controlled trials ISRCTN14930255 .
-
-###24858769
-OBJECTIVE	To determine and correlate the effect of clomiphene citrate , Letrozole in women undergoing infertility treatment on the gingival inflammatory status .
-METHODS	The present study is a randomized controlled clinical trial which consisted of 26 women using CC for three menstrual cycles , 26 women using CC for more than three cycles , 26 women using Letrozole .
-METHODS	All subjects were clinically examined for plaque levels ( Plaque Index ) , gingival inflammation , bleeding on probing ( Gingival Index , Sulcus Bleeding Index ) .
-METHODS	Scaling was done to all patients and all periodontal parameters were reassessed 1 month after scaling .
-METHODS	The results were compared with a control group of 26 women matched for age , educational status and professional level , and oral habits and who had never used ovulation drugs .
-RESULTS	Baseline scores of all the test groups showed higher amount of plaque levels and inflammation compared to control .
-RESULTS	( p < 0.05 ) .
-RESULTS	After scaling a significant reduction in inflammation was observed in all the test groups along with the control group ( p < 0.0001 ) , but women using the drugs showed persistence of inflammation compared to control ( p < 0.01 ) .
-CONCLUSIONS	It can be concluded from the present study that the presence of elevated levels of hormones due to the effect of ovulation induction drugs may be the reason for the gingival inflammation in test groups .
-
-###24429167
-OBJECTIVE	To evaluate the safety and efficacy of therapy with etanercept and methotrexate ( MTX ) in patients with active rheumatoid arthritis ( RA ) and mild hepatitis C virus ( HCV ) infection .
-METHODS	In this prospective open study , 29 patients with active RA were randomly assigned to receive therapy with MTX alone , etanercept alone , or a combination of MTX and etanercept , and monitored up to 54 weeks .
-METHODS	The primary endpoint was safety ; secondary aims were efficacy as defined by the 44-joint Disease Activity Score ( DAS44 ) and health assessment questionnaire ( HAQ ) .
-METHODS	Serum liver enzymes and HCV viral load were serially measured .
-RESULTS	In the whole cohort , aspartate aminotransferase ( AST ) serum levels were ( mean SD ) 35 3 at entry , 39 5 , 41 7 , and 38 4 at 14 , 30 , and 54 weeks , respectively ; alanine aminotransferase ( ALT ) serum levels were 43 5 at entry , 47 5 , 53 9 , and 50 6 at 14 , 30 , and 54 weeks , respectively .
-RESULTS	HCV viral load was 5.6 0.5 at entry , 5.9 0.6 , 5.7 0.3 , and 5.6 0.6 at 14 , 30 , and 54 weeks , respectively .
-RESULTS	AST and ALT did not significantly change in all 3 arms of treatment , nor did HCV viral load .
-RESULTS	A significant reduction of DAS44 ( p < 0.01 ) and HAQ ( p < 0.04 ) was detected at 54 weeks compared to baseline .
-RESULTS	No patient discontinued the therapy because of worsening of liver disease .
-CONCLUSIONS	This study showed that patients with RA and chronic HCV and mild hepatitis may be successfully treated with etanercept and MTX without increasing the risk of hepatotoxicity and HCV replication .
-CONCLUSIONS	ClinicalTrials.gov Identifier NCT01543594 .
-
-###25514794
-BACKGROUND	Despite suppressive antiretroviral therapy ( ART ) , increased levels of immune activation persist in HIV-infected subjects .
-BACKGROUND	Statins have anti-inflammatory effects and may reduce immune activation in HIV disease .
-METHODS	Stopping Atherosclerosis and Treating Unhealthy bone with RosuvastatiN in HIV ( SATURN-HIV ) is a randomized , double-blind placebo-controlled trial assessing the effect of rosuvastatin ( 10 mg daily ) on markers of cardiovascular risk and immune activation in ART-treated patients .
-METHODS	T-cell activation was measured by expression of CD38 , HLA-DR , and PD1 .
-METHODS	Monocyte activation was measured with soluble markers ( sCD14 and sCD163 ) and by enumeration of monocyte subpopulations and tissue factor expression .
-METHODS	Markers of systemic and vascular inflammation and coagulation were also measured .
-METHODS	SATURN-HIV is registered on clinicaltrials.gov ( identifier : NCT01218802 ) .
-RESULTS	Rosuvastatin , compared with placebo , reduced sCD14 ( -10.4 % vs 0.5 % , P = 0.006 ) , lipoprotein-associated phospholipase A2 ( -12.2 % vs -1.7 % , P = 0.0007 ) , and IP-10 ( -27.5 vs -8.2 % , P = 0.03 ) levels after 48 weeks .
-RESULTS	The proportion of tissue factor-positive patrolling ( CD14CD16 ) monocytes was also reduced by rosuvastatin ( -41.6 % ) compared with placebo ( -18.8 % , P = 0.005 ) .
-RESULTS	There was also a greater decrease in the proportions of activated ( CD38HLA-DR ) T cells between the arms ( -38.1 % vs -17.8 % , P = 0.009 for CD4 cells , and -44.8 % vs -27.4 % , P = 0.003 for CD8 cells ) .
-CONCLUSIONS	Forty-eight weeks of rosuvastatin treatment reduced significantly several markers of inflammation and lymphocyte and monocyte activation in ART-treated subjects .
-
-###25226738
-BACKGROUND	Honey has been shown to have beneficial effects on the glucose and lipid profiles in patients at high risk of heart diseases .
-BACKGROUND	Therefore , this study was carried out to investigate the effects of natural honey on blood glucose and lipid profile in healthy individuals .
-METHODS	A randomized controlled trial was carried out in the Army Medical College , Rawalpindi , Pakistan , spanning 4 weeks , that is , from 15th Feb-15th March 2009 .
-METHODS	A total of 70 healthy young boarders of the same college were included in the study and randomly divided into two groups of 35 each using random number table .
-METHODS	Seventy gram ( 70 g ) of honey was given to each individual in the experimental group daily for a period of 4 weeks while control group was kept on the same diet as that of experimental group except honey .
-METHODS	The fasting glucose , total cholesterol , low density lipoprotein ( LDL ) , high density lipoprotein ( HDL ) and triglyceride ( TG ) levels were measured before and after the experiment .
-RESULTS	The fasting glucose levels in both groups were raised .
-RESULTS	However , the increase in the experimental group was significantly less than that in the control group ( p < 0.05 ) .
-RESULTS	The levels of total cholesterol , LDL and triglycerides in the control group increased while those in the experiment group decreased significantly ( p < 0.05 ) , while HDL levels were decreased in the former and increased in the latter group ( p < 0.05 ) .
-CONCLUSIONS	Natural honey consumption significantly limits the rise in blood glucose along with a significant decrease in the levels of total cholesterol , LDL and triglycerides , and increase HDL in young healthy adults .
-
-###24239841
-BACKGROUND	Persistent and long-standing persistent atrial fibrillation ( AF ) often requires extensive and/or repeat radiofrequency ( RF ) ablation procedures .
-OBJECTIVE	The Tailored Treatment of Persistent Atrial Fibrillation ( TTOP-AF ) study assessed the effectiveness and safety of the phased RF system in a randomized controlled comparison of medical therapy against phased RF ablation for the management of persistent and long-standing persistent AF .
-METHODS	Patients who had failed at least 1 antiarrhythmic drug ( AAD ) were randomized ( 2:1 ) to ablation management ( AM ) or medical management ( MM ) .
-METHODS	AM patients were allowed up to 2 ablations .
-METHODS	Index and retreatment procedures consisted of pulmonary vein isolation and ablation of complex fractionated atrial electrograms .
-METHODS	MM patients received AAD changes and/or cardioversion .
-METHODS	The primary end points of the TTOP-AF study included chronic effectiveness and safety at 6 months and acute safety within 7 days of ablation .
-RESULTS	At 6 months , a greater proportion of AM patients achieved effectiveness off AAD ( 77 of 138 [ 55.8 % ] ) compared to MM patients ( 19 of 72 [ 26.4 % ] ) ( P < .0001 ) .
-RESULTS	Acutely , 92.8 % ( 128/138 ) of the procedures were successful while 12.3 % ( 17/138 ) experienced a serious procedure and/or device-related adverse event .
-RESULTS	The predefined acute safety end point was not met .
-RESULTS	The proportion of patients with chronic safety events did not differ significantly between groups .
-CONCLUSIONS	Catheter ablation of persistent/long-standing persistent AF with the phased RF ablation system is effective with greater reduction of AF compared with MM .
-CONCLUSIONS	More intense anticoagulation strategies , careful attention to catheter placement relative to the pulmonary vein ostia , and elimination of electrode interaction are expected to reduce the risk of stroke , pulmonary vein stenosis , and asymptomatic cerebral emboli .
-
-###24304689
-BACKGROUND	Chronic fatigue syndrome ( CFS ) or myalgic encephalomyelitis ( ME ) is relatively common in children with limited evidence for treatment .
-BACKGROUND	The Phil Parker Lightning Process ( LP ) is a trademarked intervention , which > 250 children use annually .
-BACKGROUND	There are no reported studies investigating the effectiveness or possible side effects of LP .
-METHODS	The trial population was drawn from the Bath and Bristol NHS specialist paediatric CFS or ME service .
-METHODS	The study was designed as a pilot randomized trial with children ( aged 12 to 18 years ) comparing specialist medical care with specialist medical care plus the Lightning Process .
-METHODS	Integrated qualitative methodology was used to explore the feasibility and acceptability of the recruitment , randomization and interventions .
-RESULTS	A total of 56 children were recruited from 156 eligible children ( 1 October 2010 to 16 June 2012 ) .
-RESULTS	Recruitment , randomization and both interventions were feasible and acceptable .
-RESULTS	Participants suggested changes to improve feasibility and acceptability and we incorporated the following in the trial protocol : stopped collecting 6-week outcomes ; introduced a second reminder letter ; used phone calls to collect primary outcomes from nonresponders ; informed participants about different approaches of each intervention and changed our recommendation for the primary outcome for the full study from school attendance to disability ( SF-36 physical function subscale ) and fatigue ( Chalder Fatigue Scale ) .
-CONCLUSIONS	Conducting randomized controlled trials ( RCTs ) to investigate an alternative treatment such as LP is feasible and acceptable for children with CFS or ME .
-CONCLUSIONS	Feasibility studies that incorporate qualitative methodology enable changes to be made to trial protocols to improve acceptability to participants .
-CONCLUSIONS	This is likely to improve recruitment rate and trial retention .
-BACKGROUND	Feasibility study first randomization : 29 September 2010 .
-BACKGROUND	Trial registration : Current Controlled Trials ISRCTN81456207 ( 31 July 2012 ) .
-BACKGROUND	Full trial first randomization : 19 September 2012 .
-
-###24746942
-BACKGROUND	Asthma guidelines recommend prescription of inhaled corticosteroids at a reduced dosage in children compared to older patients in order to minimize the systemic exposure and risk of unwanted side effects .
-BACKGROUND	In children , pressurized metered dose inhalers ( pMDI ) are recommended in combination with a valved holding chamber ( VHC ) to overcome the problem of coordinating inhalation with actuation .
-BACKGROUND	However , the influence of age and body size on the systemic exposure of drugs to be administered via a pMDI with VHC is still not fully elucidated .
-BACKGROUND	Therefore , we aimed to compare the systemic exposure to the active ingredients of a fixed combination of beclometasone-dipropionate/formoterol-fumarate administered via pMDI with VHC in children , adolescents and adults .
-METHODS	The pharmacokinetics of formoterol and beclometasone-17-monopropionate ( active metabolite of beclometasone-dipropionate ) was evaluated over 8h from three studies , each performed in a different age and body size group .
-METHODS	Children ( 7-11 years , n = 20 ) , adolescents ( 12-17 years , n = 29 ) and adults ( 18 years , n = 24 ) received a single dose of beclometasone/formoterol ( children : 200g/24g , adolescents and adults : 400g/24g ) via pMDI with AeroChamber Plus .
-RESULTS	The systemic exposure in children in comparison to adolescents was equivalent for formoterol while it was halved for beclometasone-17-monopropionate in accordance with the halved dose of beclometasone administered in children ( 90 % CIs within 0.8-1 .25 for formoterol and 0.4-0 .625 for beclometasone-17-monopropionate ) .
-RESULTS	The systemic exposure to beclometasone-17-monopropionate and formoterol was equivalent between adolescents and adults .
-CONCLUSIONS	The systemic exposure to the active ingredients of a fixed dose combination of beclometasone/formoterol administered via pMDI with AeroChamber Plus correlates with the nominal dose independently of patient age and body size .
-CONCLUSIONS	Thus , dose reduction in relation to age when using a pMDI with VHC may be unnecessary for reducing the systemic exposure in children .
-
-###24508083
-OBJECTIVE	Post-tonsillectomy pain is a notable concern and thermal injury produced by electric surgical devices is considered a main cause .
-OBJECTIVE	Intraoperative cooling of the tonsillar fossa and pharyngeal mucosa with cold water has effectively reduced postoperative pain , but no studies have fully evaluated the effects of this technique with a proper study design .
-OBJECTIVE	We assessed mucosal cooling in two groups of patients undergoing the same surgical technique by a single surgeon , with one group receiving cold-water cooling and the other group as a control .
-METHODS	Forty patients who underwent monopolar electrocautery tonsillectomy were randomly assigned to two groups ( n = 20 for each group ) .
-METHODS	Group 1 received cooling of the tonsillar fossa and pharyngeal mucosa with 4 C saline just after removal of each tonsil whereas Group 2 did not receive cooling .
-METHODS	Postoperative pain was recorded on operation day and 1 , 2 , 4 , 7 , and 10 days postoperatively .
-METHODS	Post-tonsillectomy pain , return to normal diet , and incidence of postoperative bleeding were compared between the groups .
-RESULTS	Post-tonsillectomy pain on 6 selected days and overall pain during the 10-day follow-up period were significantly lower in Group 1 .
-RESULTS	However , return to normal diet and incidence of postoperative bleeding did not differ significantly between the groups .
-CONCLUSIONS	Intraoperative application of cold water after tonsillectomy significantly reduced postoperative pain .
-CONCLUSIONS	We recommend cooling the tonsillar fossa and pharyngeal mucosa with cold water during tonsillectomy to easily and effectively reduce post-tonsillectomy pain .
-
-###24522223
-BACKGROUND	Informed consent ( IC ) comprehension is suboptimal .
-BACKGROUND	Repeat back ( RB ) - asking the patient to repeat in their own words key elements of the consent-is believed to improve the consent process .
-OBJECTIVE	This study aims to assess the impact of RB on patient perceptions of surgical informed consent .
-METHODS	Secondary analysis of a randomized trial .
-METHODS	Elective surgical patients were consented using iMedConsent , the VA 's computer-based IC platform .
-METHODS	Patients were randomized to RB ( IC could not be signed until the patient satisfactorily expressed key elements ) or standard iMedConsent ( no RB ) .
-METHODS	A questionnaire was given immediately after IC assessing time for decision , satisfaction with and ease of understanding consent , and the amount of information provided about the proposed surgery ( e.g. , indications , benefits , risks , and alternatives ) .
-METHODS	Groups were compared with tests .
-RESULTS	We enrolled 575 subjects ( 276 RB and 299 no RB ) ; 92 % were men with a mean age of 61.6 years and high school level reading ability .
-RESULTS	The groups were comparable in their perceptions regarding time to make a decision ( RB 88 % Strongly Agree ( SA ) , no RB 88 % SA ; P = 0.61 ) , satisfaction with consent ( RB 90 % SA , no RB 87 % SA ; P = 0.27 ) , ease of understanding ( RB 69 % SA , no RB 67 % SA ; P = 0.73 ) receipt of the right amount of information regarding the indications ( RB 85 % SA , no RB 87 % ; P = 0.61 ) , the benefits ( RB 87 % SA , no RB 86 % SA ; P = 0.29 ) , and the risks ( RB 87 % SA , no RB 84 % SA ; P = 0.19 ) of surgery .
-RESULTS	More of the RB group felt they received the right amount of information about alternatives to surgery ( RB 80 % SA ) than did the no RB group ( 69 % SA ) ; P = 0.01 .
-CONCLUSIONS	Patients were highly satisfied with RB during surgical IC RB is not detrimental to the consent process and may improve informed consent for surgery .
-BACKGROUND	Clinical Trials Identifier NCT00288899 http://www.clinicaltrials.gov .
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-###25496354
-OBJECTIVE	To compare the performance of three continence management devices and absorbent pads used by men with persistent urinary incontinence ( > 1year ) after treatment for prostate cancer .
-METHODS	Randomised , controlled trial of 56 men with 1-year follow-up .
-METHODS	Three devices were tested for 3weeks each : sheath drainage system , body-worn urinal ( BWU ) and penile clamp .
-METHODS	Device and pad performance were assessed .
-METHODS	Quality of life ( QoL ) was measured at baseline and follow-up with the King 's Health Questionnaire .
-METHODS	Stated ( intended use ) and revealed ( actual use ) preference for products were assessed .
-METHODS	Value-for-money was gathered .
-RESULTS	Substantial and significant differences in performance were found .
-RESULTS	The sheath was rated as ` good ' for extended use ( e.g. golf and travel ) when pad changing is difficult ; for keeping skin dry , not leaking , not smelling and convenient for storage and travel .
-RESULTS	The BWU was generally rated worse than the sheath and was mainly used for similar activities but by men who could not use a sheath ( e.g. retracted penis ) and was not good for seated activities .
-RESULTS	The clamp was good for short vigorous activities like swimming/exercise ; it was the most secure , least likely to leak , most discreet but almost all men described it as uncomfortable or painful .
-RESULTS	The pads were good for everyday activities and best for night-time use ; most easy to use , comfortable when dry but most likely to leak and most uncomfortable when wet .
-RESULTS	There was a preference for having a mixture of products to meet daytime needs ; around two-thirds of men were using a combination of pads and devices after testing compared with baseline .
-CONCLUSIONS	This is the first trial to systematically compare different continence management devices for men .
-CONCLUSIONS	Pads and devices have different strengths , which make them particularly suited to certain circumstances and activities .
-CONCLUSIONS	Most men prefer to use pads at night but would choose a mixture of pads and devices during the day .
-CONCLUSIONS	Device limitations were important but may be overcome by better design .
-
-###24628577
-BACKGROUND	Lipid-based nutrient supplements ( LNS ) have been effective in the treatment of acute malnutrition among children .
-BACKGROUND	We evaluated the use of LNS supplementation for improving the micronutrient status of young children .
-METHODS	A 12-month randomised controlled trial was conducted among children aged 6-18 months living in Intibuc , Honduras .
-METHODS	Communities ( n = 18 ) were randomised into clusters matched by poverty indicators ( 9 intervention , n = 160 and 9 controls , n = 140 ) .
-METHODS	Intervention participants received LNS .
-METHODS	All children received food vouchers and nutrition education .
-METHODS	Primary outcomes included measures of micronutrient status : at baseline , 6 and 12 months ' blood were collected for assessment of folate , iron , zinc , riboflavin , and vitamin B12 status ; haemoglobin was measured every 3 months ; and dietary and anthropometry collected monthly .
-METHODS	Longitudinal analyses were based on intent to treat and LNS adherence .
-METHODS	Generalised estimating equations were used in the estimation of generalised linear regression models specified for the data .
-RESULTS	At 6-month follow-up , children in the intervention group had a lower proportion classified as deficient for B12 ( 43.6 % ) compared with the control ( 67.7 % ; P = 0.03 ) .
-RESULTS	The intervention group had a higher mean concentration for folate at 6 months ( P = 0.06 ) , and improvements continued through 12 months for folate ( P = 0.002 ) and vitamin A deficiency ( P = 0.03 ) .
-RESULTS	This pattern of results , with improved significance , remained in subanalysis based on LNS adherence .
-CONCLUSIONS	These data demonstrate that LNS improved select micronutrient status in young non-malnourished Honduran children .
-
-###24358296
-BACKGROUND	Diesel exhaust ( DE ) exposures are very common , yet exposure-related symptoms have n't been rigorously examined .
-OBJECTIVE	Describe symptomatic responses to freshly generated and diluted DE and filtered air ( FA ) in a controlled human exposure setting ; assess whether such responses are altered by perception of exposure .
-METHODS	43 subjects participated within three double-blind crossover experiments to order-randomized DE exposure levels ( FA and DE calibrated at 100 and/or 200 micrograms/m ( 3 ) particulate matter of diameter less than 2.5 microns ) , and completed questionnaires regarding symptoms and dose perception .
-RESULTS	For a given symptom cluster , the majority of those exposed to moderate concentrations of diesel exhaust do not report such symptoms .
-RESULTS	The most commonly reported symptom cluster was of the nose ( 29 % ) .
-RESULTS	Blinding to exposure is generally effective .
-RESULTS	Perceived exposure , rather than true exposure , is the dominant modifier of symptom reporting .
-CONCLUSIONS	Controlled human exposure to moderate-dose diesel exhaust is associated with a range of mild symptoms , though the majority of individuals will not experience any given symptom .
-CONCLUSIONS	Blinding to DE exposure is generally effective .
-CONCLUSIONS	Perceived DE exposure , rather than true DE exposure , is the dominant modifier of symptom reporting .
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-###24641302
-BACKGROUND	Electrobrasion , like dermabrasion , is a method of surgical planing that is purported to improve postoperative scarring .
-BACKGROUND	Data regarding its benefits and harms relative to dermabrasion are absent .
-OBJECTIVE	To compare the efficacy and potential harms of electrobrasion and dermabrasion .
-METHODS	This was a pragmatic , randomized , double-blind , split-scar intervention in patients with suboptimal surgical outcomes .
-METHODS	Half of the wound was randomized to treatment with dermabrasion and half to electrobrasion .
-METHODS	At 3-month follow-up , both the patient and a blinded investigator evaluated the wound .
-RESULTS	Electrobrasion and dermabrasion reduced the mean scores of the Manchester Scar Scale 16 and 13 points from baseline , respectively ( P = 00003 ) .
-RESULTS	The difference between treatments was not significant ( P = 008 ) .
-RESULTS	Global cosmetic improvement by physician and patient assessment indicated clinical improvement for both procedures but did not demonstrate statistical significance between treatments ( P = 057 , P = 032 for physician and patient , respectively ) .
-CONCLUSIONS	Both dermabrasion and electrobrasion improved scars , but there was no significant difference between the outcomes of the two procedures on several measures .
-CONCLUSIONS	Procedure time and bleeding time were significantly lower for electrobrasion .
-
-###24643636
-OBJECTIVE	This study was designed to investigate the effects of omega-3 fatty acids on depression and chronic inflammation in hemodialysis patients .
-METHODS	Fifty-four maintenance hemodialysis patients were randomized to ingest two omega-3 ( each containing 180 mg eicosapentaenoic acid and 120 mg docosahexaenoic acid ) or placebo capsules , three times daily for 4 months .
-METHODS	Beck Depression Inventory ( BDI ) score and serum levels of C-reactive protein ( CRP ) , interleukin ( IL ) -6 , IL-10 , tumor necrosis factor ( TNF ) - , ferritin , intact parathyroid hormone ( iPTH ) , and ratios of IL-10 to IL-6 and IL-10 to TNF - were measured at baseline and at the end of the study .
-RESULTS	Omega-3 supplement lowered BDI score significantly after 4 months of intervention .
-RESULTS	Among pro- and anti-inflammatory mediators , only serum ferritin level and IL-10 to IL-6 ratio showed significant changes in favor of omega-3 supplement during the study .
-RESULTS	In linear regression model adjusted for baseline values , omega-3 treatment was a significant predictor of reduced serum CRP , ferritin , and iPTH levels , and increased IL-10 to IL-6 ratio .
-RESULTS	No significant association was found between the anti-inflammatory and anti-depressant effects of omega-3 supplement .
-CONCLUSIONS	Supplemental use of omega-3 fatty acids decreases depressive symptoms in hemodialysis patients apart from their anti-inflammatory effects .
-
-###24284002
-BACKGROUND	Skin-to-skin contact ( SSC ) between mother and infant , commonly referred to as Kangaroo Mother Care ( KMC ) , is recommended as an intervention for procedural pain .
-BACKGROUND	Evidence demonstrates its consistent efficacy in reducing pain for a single painful procedure .
-BACKGROUND	The purpose of this study is to examine the sustained efficacy of KMC , provided during all routine painful procedures for the duration of Neonatal Intensive Care Unit ( NICU ) hospitalization , in diminishing behavioral pain response in preterm neonates .
-BACKGROUND	The efficacy of KMC alone will be compared to standard care of 24 % oral sucrose , as well as the combination of KMC and 24 % oral sucrose .
-METHODS	Infants admitted to the NICU who are less than 36 6/7 weeks gestational age ( according to early ultrasound ) , that are stable enough to be held in KMC , will be considered eligible ( N = 258 ) .
-METHODS	Using a single-blinded randomized parallel group design , participants will be assigned to one of three possible interventions : 1 ) KMC , 2 ) combined KMC and sucrose , and 3 ) sucrose alone , when they undergo any routine painful procedure ( heel lance , venipuncture , intravenous , oro/nasogastric insertion ) .
-METHODS	The primary outcome is infant 's pain intensity , which will be assessed using the Premature Infant Pain Profile ( PIPP ) .
-METHODS	The secondary outcome will be maturity of neurobehavioral functioning , as measured by the Neurobehavioral Assessment of the Preterm Infant ( NAPI ) .
-METHODS	Gestational age , cumulative exposure to KMC provided during non-pain contexts , and maternal cortisol levels will be considered in the analysis .
-METHODS	Clinical feasibility will be accounted for from nurse and maternal questionnaires .
-CONCLUSIONS	This will be the first study to examine the repeated use of KMC for managing procedural pain in preterm neonates .
-CONCLUSIONS	It is also the first to compare KMC to sucrose , or the interventions in combination , across time .
-CONCLUSIONS	Based on the theoretical framework of the brain opioid theory of attachment , it is expected that KMC will be a preferred standard of care .
-CONCLUSIONS	However , current pain management guidelines are based on minimal data on repeated use of either intervention .
-CONCLUSIONS	Therefore , regardless of the outcomes of this study , results will have important implications for guidelines and practices related to management of procedural pain in preterm infants .
-BACKGROUND	ClinicalTrials.gov Identifier : NCT01561547 .
-
-###24515353
-OBJECTIVE	Schools are considered an attractive setting to promote healthy living behaviors in children , but previous school-based interventions aimed at preventing weight gain in children have yielded mixed results .
-OBJECTIVE	Novel school-based approaches are needed to modify healthy living behaviors and attenuate weight gain in children .
-OBJECTIVE	To assess the effectiveness of a peer-led healthy living program called Healthy Buddies on weight gain and its determinants when disseminated at the provincial level to elementary school students .
-METHODS	Cluster-randomized effectiveness trial performed during the 2009-2010 school year .
-METHODS	Baseline and follow-up measurements were made in October 2009 and May 2010 , respectively .
-METHODS	The study was performed in 19 elementary schools in Manitoba , Canada , and included 647 elementary school students aged 6 to 12 years ( 48 % girls ) .
-METHODS	Schools were randomized to receive regular curriculum or Healthy Buddies lesson plans .
-METHODS	Lesson plans were delivered by older ( 9 - to 12-year-old ) elementary school students to the younger ( 6 - to 8-year-old ) peers and targeted 3 components of health : physical activity , healthy eating , and self-esteem and body image .
-METHODS	The primary outcome measures were the change in waist circumference and body mass index z score .
-METHODS	Secondary outcomes included physical activity ( steps per day ) , cardiorespiratory fitness , self-efficacy , healthy living knowledge , and self-reported dietary intake .
-RESULTS	At baseline , 36 % of children were overweight or obese and 11 % achieved the recommended 13,500 steps per day .
-RESULTS	Intention-to-treat analyses showed that waist circumference declined significantly in the intervention group relative to controls : -1.42 cm ( -2.68 to -0.17 ; P = .03 ) .
-RESULTS	Reductions in waist circumference were particularly significant for children who were younger , overweight or obese , or attending First Nations schools .
-RESULTS	No difference in body mass index z score was observed between groups .
-RESULTS	Self-efficacy , healthy living knowledge , and dietary intake significantly improved in younger peers who received the intervention compared with students from control schools .
-RESULTS	No differences were observed in daily step counts or cardiorespiratory fitness between the groups .
-CONCLUSIONS	The implementation of Healthy Buddies lesson plans delivered by older peers within an elementary school setting is an effective method for attenuating increases in central adiposity and improving knowledge of healthy living behaviors among elementary school students .
-CONCLUSIONS	Improvements were achieved with parallel improvements in diet quality , self-efficacy , and knowledge of healthy living .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01979978 .
-
-###25023200
-BACKGROUND	Acute kidney injury is common in hospitalized patients , increases morbidity and mortality , and is under-recognized .
-BACKGROUND	To improve provider recognition , we previously developed an electronic alert system for acute kidney injury .
-BACKGROUND	To test the hypothesis that this electronic acute kidney injury alert could improve patient outcome , we designed a randomized controlled trial to test the effectiveness of this alert in hospitalized patients .
-BACKGROUND	The study design presented several methodologic , ethical , and statistical challenges .
-OBJECTIVE	To highlight the challenges faced and the solutions employed in the design and implementation of a clinical trial to determine whether the provision of an early electronic alert for acute kidney injury would improve outcomes in hospitalized patients .
-OBJECTIVE	Challenges included how to randomize the delivery of the alert system and the ethical framework for waiving informed consent .
-OBJECTIVE	Other methodologic challenges included the selection and statistical evaluation of our study outcome , a ranked-composite of a continuous covariate ( creatinine ) and two dichotomous outcomes ( dialysis and death ) , and the use of the medical record as a source of trial data .
-METHODS	We have designed a randomized trial to assess the effectiveness of an electronic alert system for acute kidney injury .
-METHODS	With broad inclusion criteria , and a waiver of informed consent , we enroll and randomize virtually every patient with acute kidney injury in our hospital .
-RESULTS	As of 31 March 2014 , we have enrolled 2373 patients of 2400 targeted .
-RESULTS	Pre-alert data demonstrated a strong association between severity of acute kidney injury and inpatient mortality with a range of 6.4 % in those with mild , stage 1 acute kidney injury , to 29 % among those with stage 3 acute kidney injury ( p < 0.001 ) .
-RESULTS	We judged that informed consent would undermine the scientific validity of the study and present harms that are out of proportion to the very low risk intervention .
-CONCLUSIONS	Our study demonstrates the feasibility of designing an ethical randomized controlled trial of an early electronic alert for acute kidney injury without obtaining informed consent from individual participants .
-CONCLUSIONS	Our study outcome may serve as a model for other studies of acute kidney injury , insofar as our paradigm accounts for the effect that early death and dialysis have on assessment of acute kidney injury severity as defined by maximum achieved serum creatinine .
-
-###25759969
-OBJECTIVE	To compare transjugular intrahepatic portosystemic shunt ( TIPS ) placement with or without variceal embolization with endoscopic band ligation ( EBL ) plus propranolol in preventing recurrent esophageal variceal bleeding in patients with advanced cirrhosis and portal vein thrombosis .
-METHODS	The present randomized controlled trial was approved by the ethics committee board of West China Hospital .
-METHODS	Written informed consent was obtained from each patient .
-METHODS	Between January 2010 and December 2012 , 73 patients were randomly allocated to receive TIPS ( n = 37 ) or EBL plus propranolol ( n = 36 ) .
-METHODS	The comparisons of recurrent variceal bleeding , hepatic encephalopathy , and survival rates were based on the Kaplan-Meier method and were compared using the log-rank test .
-RESULTS	The mean follow-up time was 22.8 months 7.7 ( standard deviation ) in the TIPS group and 20.9 months 8.9 in the EBL group .
-RESULTS	The 2-year probability of remaining free of recurrent variceal bleeding was higher in the TIPS group ( 77.8 % ) than in the EBL group ( 42.9 % ) ( P = .002 ) .
-RESULTS	Overall recanalization was achieved in 24 ( 64.9 % ) patients from the TIPS group and seven ( 19.4 % ) patients from the EBL group .
-RESULTS	The hepatic encephalopathy rates exhibited no significant differences between the two groups ( P = .53 ) .
-RESULTS	The 1 - and 2-year probability of survival was 86.5 % and 72.9 % , respectively , in the TIPS group and 83.3 % and 57.2 % , respectively , in the EBL group , with no significant difference ( P = .23 ) .
-CONCLUSIONS	TIPS was more effective than EBL plus propranolol in preventing recurrent esophageal variceal bleeding in patients with advanced cirrhosis and portal vein thrombosis and did not increase the incidence of hepatic encephalopathy .
-CONCLUSIONS	Survival was similar in both groups .
-
-###24240244
-OBJECTIVE	To evaluate the efficacy and safety of two low-dose levonorgestrel intrauterine contraceptive systems .
-METHODS	Nulliparous and parous women aged 18-35 years with regular menstrual cycles ( 21-35 days ) requesting contraception were randomized to 3 years of treatment with one of two levonorgestrel intrauterine contraceptive systems : 13.5 mg total content or 19.5 mg total content .
-METHODS	The primary outcome was the pregnancy rate , calculated as the Pearl Index .
-RESULTS	Overall , 1,432 and 1,452 women in the 13.5 mg intrauterine contraceptive system and 19.5 mg intrauterine contraceptive system groups , respectively , had a placement attempted and were included in the full analysis set to evaluate efficacy and safety .
-RESULTS	Mean ( standard deviation ) age was 27.1 ( 4.8 ) years ; 39.2 % were nulliparous .
-RESULTS	Over the 3-year study period , 0.33 pregnancies per 100 women-years ( 95 % confidence interval [ CI ] 0.16-0 .60 ) were observed with the 13.5 mg intrauterine contraceptive system compared with 0.31 per 100 women-years ( 95 % CI 0.15-0 .57 ) with the 19.5 mg intrauterine contraceptive system .
-RESULTS	Kaplan-Meier estimates for that period were 0.009 and 0.010 , respectively .
-RESULTS	At least partial expulsions occurred in 4.56 % and 3.58 % and discontinuation rates resulting from a reported adverse event occurred in 21.9 % and 19.1 % , respectively .
-RESULTS	Ten of the 20 pregnancies were ectopic .
-RESULTS	Serious adverse events included six cases of pelvic inflammatory disease and one partial uterine perforation .
-CONCLUSIONS	Both lower-dose levonorgestrel intrauterine contraceptive systems were highly effective for 3 years of use and generally well tolerated .
-BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT00528112 .
-METHODS	: I.
-
-###25158551
-BACKGROUND	Extracorporeal shock wave lithotripsy ( SWL ) is a wide spread option for the treatment of the upper urinary tract urolithiasis .
-BACKGROUND	EAU guideline recommends the treatment with 60-90 shots per minute for the optimal frequency of SWL , but there is no report on the efficiency of SWL with the frequency less than 60 shots per minute .
-OBJECTIVE	To determine the optimal shock wave frequency of SWL , we prospectively randomized total 247 patients with ureteral stone to the four different treatment groups : group A ( 76 pts . )
-OBJECTIVE	, group B ( 68 pts . )
-OBJECTIVE	, group C ( 55 pts . )
-OBJECTIVE	and group D ( 48 pts . )
-OBJECTIVE	These groups were treated with the frequencies of 80 , 60 , 45 and 30 shots per minute respectively using Dornier Lithotripter D.
-OBJECTIVE	One treatment took forty minutes , resulting in the total shock waves per session of 3,200 , 2,400 , 1,800 and 1,200 for group A , B , C and D , respectively .
-RESULTS	The total numbers of the SWL sessions were statistically not different among the four groups .
-RESULTS	Importantly , there was statistically no difference among the four groups about the stone clearance rates and the stone reduction efficiencies on the next day , after one week and after one month of the treatment .
-RESULTS	In addition , only two additional ureteral stenting for pyelonephritis and one renal subcapsular hematoma were observed .
-CONCLUSIONS	This study suggests that the efficiency of SWL with the frequency of 30 or 45 shots per minute is similar to that of 60 or 80 shots for stone reduction and clearance .
-
-###24405838
-OBJECTIVE	Insulin resistance plays an important role in the pathophysiology in chronic heart failure ( CHF ) .
-OBJECTIVE	Diuretics generally have harmful effects on glucose metabolism , however , the effect of mineral corticoid receptor blockers on insulin resistance in CHF is unclear .
-OBJECTIVE	This study aimed to evaluate the effects of the aldosterone blocker spironolactone , in comparison with furosemide , on insulin resistance in CHF patients .
-METHODS	The effect of spironolactone ( 25mg/day ) and furosemide ( 20mg/day ) on IR for 16 weeks each was analyzed in 16 CHF patients using a double-blind , placebo-controlled , randomized cross-over study design .
-RESULTS	Plasma BNP and left ventricular ejection fraction were improved with both treatments ( furosemide : p = 0.02 and p = 0.009 , respectively , spironolactone : p = 0.03 and p = 0.007 , respectively ) .
-RESULTS	Fasting plasma glucose was not changed ; however , plasma insulin levels decreased and insulin sensitivity ( by homeostasis model assessment : HOMA-IR ) improved with spironolactone as compared to furosemide ( p < 0.0005 ) .
-RESULTS	TNF - , IL-6 and MCP-1 decreased with spironolactone ( p = 0.002 , p = 0.02 and p = 0.02 vs. baseline , respectively ) , but not with furosemide .
-RESULTS	Matrix metalloproteinase ( MMP ) -2 and MMP-9 were decreased with spironolactone ( p = 0.003 and p = 0.04 vs. baseline , respectively ) , but not furosemide .
-RESULTS	Changes in TNF - , IL-6 and MCP-1 levels after spironolactone treatment were significantly correlated with changes in HOMA-IR ( r = 0.61 , r = 0.55 and r = 0.65 , respectively ; p = 0.01 , p = 0.03 and p = 0.01 , respectively ) .
-RESULTS	Furthermore , changes in MMP-2 and MMP-9 levels were significantly correlated with changes in HOMA-IR ( r = 0.58 and r = 0.58 , respectively ; p = 0.02 and p = 0.02 , respectively ) .
-CONCLUSIONS	Spironolactone , not furosemide , improved insulin resistance in CHF patients probably by the inhibition of inflammatory cytokines and MMPs .
-
-###25765512
-BACKGROUND	The FAST ( food allergy-specific immunotherapy ) project aims at developing safe and effective subcutaneous immunotherapy for fish allergy , using recombinant hypoallergenic carp parvalbumin , Cyp c 1 .
-OBJECTIVE	Preclinical characterization and good manufacturing practice ( GMP ) production of mutant Cyp ( mCyp ) c 1 .
-METHODS	Escherichia coli-produced mCyp c 1 was purified using standard chromatographic techniques .
-METHODS	Physicochemical properties were investigated by gel electrophoresis , size exclusion chromatography , circular dichroism spectroscopy , reverse-phase high-performance liquid chromatography and mass spectrometry .
-METHODS	Allergenicity was assessed by ImmunoCAP inhibition and basophil histamine release assay , immunogenicity by immunization of laboratory animals and stimulation of patients ' peripheral blood mononuclear cells ( PBMCs ) .
-METHODS	Reference molecules were purified wild-type Cyp c 1 ( natural and/or recombinant ) .
-METHODS	GMP-compliant alum-adsorbed mCyp c 1 was tested for acute toxicity in mice and rabbits and for repeated-dose toxicity in mice .
-METHODS	Accelerated and real-time protocols were used to evaluate stability of mCyp c 1 as drug substance and drug product .
-RESULTS	Purified mCyp c 1 behaves as a folded and stable molecule .
-RESULTS	Using sera of 26 double-blind placebo-controlled food-challenge-proven fish-allergic patients , reduction in allergenic activity ranged from 10 - to 5,000-fold ( 1,000-fold on average ) , but with retained immunogenicity ( immunization in mice/rabbits ) and potency to stimulate human PBMCs .
-RESULTS	Toxicity studies revealed no toxic effects and real-time stability studies on the Al ( OH ) 3-adsorbed drug product demonstrated at least 20 months of stability .
-CONCLUSIONS	The GMP drug product developed for treatment of fish allergy has the characteristics targeted for in FAST : i.e. hypoallergenicity with retained immunogenicity .
-CONCLUSIONS	These results have warranted first-in-man immunotherapy studies to evaluate the safety of this innovative vaccine .
-
-###24342144
-OBJECTIVE	We evaluated the effect of alvimopan treatment vs placebo on health care utilization and costs related to gastrointestinal recovery in patients treated with radical cystectomy in a randomized , phase 4 clinical trial .
-METHODS	Resource utilization data were prospectively collected and evaluated by cost consequence analysis .
-METHODS	Hospital costs were estimated from 2012 Medicare reimbursement rates and medication wholesale acquisition costs .
-METHODS	Differences in base case mean costs between the study cohorts for total postoperative ileus related costs ( hospital days , study drug , nasogastric tubes , postoperative ileus related concomitant medication and postoperative ileus related readmissions ) and total combined costs ( postoperative ileus related , laboratory , electrocardiograms , nonpostoperative ileus related concomitant medication and nonpostoperative ileus related readmission ) were evaluated by probabilistic sensitivity analysis using a bootstrap approach .
-RESULTS	Mean hospital stay was 2.63 days shorter for alvimopan than placebo ( meanSD 8.443.05 vs 11.078.23 days , p = 0.005 ) .
-RESULTS	Use of medications or interventions likely intended to diagnose or manage postoperative ileus was lower for alvimopan than for placebo , eg total parenteral nutrition 10 % vs 25 % ( p = 0.001 ) .
-RESULTS	Postoperative ileus related health care costs were $ 2,340 lower for alvimopan and mean total combined costs were decreased by $ 2,640 per patient for alvimopan vs placebo .
-RESULTS	Analysis using a 10,000-iteration bootstrap approach showed that the mean difference in postoperative ileus related costs ( p = 0.04 ) but not total combined costs ( p = 0.068 ) was significantly lower for alvimopan than for placebo .
-CONCLUSIONS	In patients treated with radical cystectomy alvimopan decreased hospitalization cost by reducing the health care services associated with postoperative ileus and decreasing the hospital stay .
-
-###25128076
-OBJECTIVE	The feasibility of applying the Fit fOR The Aged ( FORTA ) list , a drug classification combining positive and negative labeling of drugs , should be studied in geriatric patients and medication quality and clinical endpoints measured .
-OBJECTIVE	FORTA labels range from A ( indispensable ) , B ( beneficial ) , C ( questionable ) to D ( avoid ) .
-METHODS	A prospective randomized controlled pilot trial was performed in hospitalized geriatric patients in whom the FORTA instrument or standard care was applied .
-METHODS	Patients were randomly admitted to an intervention and a control ward .
-METHODS	Changes of FORTA label distributions between admission and discharge , over - and under-prescription rates , clinical endpoints including the number of falls during the hospitalization , and Barthel Index ( BI ) at admission and discharge were measured .
-RESULTS	Polypharmacy persisted in both groups .
-RESULTS	At discharge , a higher rate of A drugs was prescribed in the intervention group ( 58 patients , median age 84 years ) vs. standard care ( 56 patients , median age 83 years , p < 0.02 ) , and both over - and under-prescriptions were significantly lower in the FORTA than in the control group ( p < 0.03 ) .
-RESULTS	Two ( 3.4 % ) intervention , but 12 ( 21.4 % ) control , patients fell at least once ( p < 0.001 ) .
-RESULTS	The fall rate per 1,000 patient years was 1.58.3 in the intervention and 10.625.4 in the control group ( p < 0.004 ) .
-CONCLUSIONS	This pilot study shows that the application of the FORTA list is feasible in geriatric patients .
-CONCLUSIONS	In this small study , the medication quality improved in the intervention group , but polypharmacy persisted in both groups .
-CONCLUSIONS	The fall rate was significantly lower in the intervention group .
-CONCLUSIONS	These encouraging results must be interpreted carefully .
-
-###25123239
-BACKGROUND	The use of highly crosslinked polyethylene ( HXLPE ) is now commonplace for total hip arthroplasty .
-BACKGROUND	Hip simulator studies and short-term in vivo measurements suggest that the wear rate of some types of HXLPE is significantly less than conventional ultrahigh-molecular-weight polyethylene ( UHMWPE ) .
-BACKGROUND	However , there are few long-term data to support its use .
-OBJECTIVE	The aim of this study was to measure the long-term steady-state wear of HXLPE compared with UHMWPE liners in a prospective , double-blind , randomized controlled trial using radiostereometric analysis .
-METHODS	Fifty-four patients were randomized to receive hip arthroplasties with either UHMWPE liners or HXLPE liners .
-METHODS	Complete followup was available on 39 of these patients ( 72 % ) .
-METHODS	All patients received the same cemented stem and an uncemented acetabular component .
-METHODS	Three-dimensional penetration of the head into the socket was determined at 10 years using a radiostereometric analysis system , which has an in vivo accuracy of < 0.1 mm .
-METHODS	Oxford Hip Scores were compared between the groups .
-RESULTS	At 10 years there was significantly less wear of HXLPE ( 0.003 mm/year ; 95 % confidence interval [ CI ] , 0.010 ; SD 0.023 ; range , -0.057 to 0.074 ) compared with UHMWPE ( 0.030 mm/year ; 95 % CI , 0.012 ; p < 0.001 ; SD 0.0.27 ; range , -0.001 to 0.164 ) .
-RESULTS	The volumetric penetration from 1 to 10 years for the UHMWPE group was 98 mm3 ( 95 % CI , 46 mm3 ; SD 102 mm3 ; range , -4 to 430 mm3 ) compared with 14 mm3 ( 95 % CI , 40 mm3 ; SD 91 mm3 ; range , -189 to 242 mm3 ) for the HXLPE group ( p = 0.01 ) .
-CONCLUSIONS	This study demonstrates that HXLPE has little detectable steady-state in vivo wear .
-CONCLUSIONS	This may result in fewer reoperations from loosening ; however , careful clinical followup into the second decade still needs to be performed .
-METHODS	Level I , therapeutic study .
-METHODS	See the Guidelines for Authors for a complete description of levels of evidence .
-
-###25697494
-OBJECTIVE	To determine whether some participants in the Diabetes Prevention Program were more or less likely to benefit from metformin or a structured lifestyle modification program .
-METHODS	Post hoc analysis of the Diabetes Prevention Program , a randomized controlled trial .
-METHODS	Ambulatory care patients .
-METHODS	3060 people without diabetes but with evidence of impaired glucose metabolism .
-METHODS	Intervention groups received metformin or a lifestyle modification program with the goals of weight loss and physical activity .
-METHODS	Development of diabetes , stratified by the risk of developing diabetes according to a diabetes risk prediction model .
-RESULTS	Of the 3081 participants with impaired glucose metabolism at baseline , 655 ( 21 % ) progressed to diabetes over a median 2.8 years ' follow-up .
-RESULTS	The diabetes risk model had good discrimination ( C statistic = 0.73 ) and calibration .
-RESULTS	Although the lifestyle intervention provided a sixfold greater absolute risk reduction in the highest risk quarter than in the lowest risk quarter , patients in the lowest risk quarter still received substantial benefit ( three year absolute risk reduction 4.9 % v 28.3 % in highest risk quarter ; numbers needed to treat of 20.4 and 3.5 , respectively ) .
-RESULTS	The benefit of metformin , however , was seen almost entirely in patients in the top quarter of risk of diabetes .
-RESULTS	No benefit was seen in the lowest risk quarter .
-RESULTS	Participants in the highest risk quarter averaged a 21.4 % three year absolute risk reduction ( number needed to treat 4.6 ) .
-CONCLUSIONS	Patients at high risk of diabetes have substantial variation in their likelihood of receiving benefit from diabetes prevention treatments .
-CONCLUSIONS	Using this knowledge could decrease overtreatment and make prevention of diabetes far more efficient , effective , and patient centered , provided that decision making is based on an accurate risk prediction tool .
-
-###25720848
-OBJECTIVE	Our objective was to evaluate the efficacy and safety of Batroxobin on blood loss during spinal operations .
-METHODS	After obtaining approval from the ethics committee at the hospital along with informed written consent , we performed a double-blind , randomized , placebo-controlled study with 100 patients who were randomized equally into 2 groups ( Batroxobin and placebo ) .
-METHODS	Patients received either 2 ku IV 15 min before surgery and followed 1 ku IM of Batroxobin following surgery , or an equivalent volume of placebo ( normal saline ) .
-METHODS	Cost of Batroxobin treatment is amounted to 84.75 euros .
-METHODS	The primary outcomes were intraoperative , 24 h postoperative , and total perioperative blood loss .
-METHODS	Secondary outcomes were hemoglobin ( Hb ) , red blood cell count ( RBC ) , the volume of blood/fluid transfusion intraoperatively , and 24 h postoperatively .
-METHODS	Safety evaluation parameters were the incidence of venous thrombosis in the lower extremities , active partial thromboplastin time , prothrombin time , thrombin time , and fibrinogen .
-METHODS	The data were analyzed using the Statistical Package for the Social Science Version 12.0 .
-METHODS	The results were presented as mean SEM .
-METHODS	The Mann-Whitney test and Independent Student t test , when appropriate , were used to compare the 2 groups , and differences were considered significant if the P value was < 0.05 .
-RESULTS	88 patients were included in the analysis while 12 patients were withdrawn from the study due to extended surgical duration , change of surgical procedure , or after the patients ' request .
-RESULTS	The total perioperative blood loss was approximately 31 % lower in patients given Batroxobin versus placebo ( 700.5 45.81 vs 485.7 30.01 mL , P = 0.001 ) .
-RESULTS	The Batroxobin group had significantly less intraoperative blood loss ( 326.1 24.16 ) compared to the placebo group ( 556.0 43.58 ) , but there was no difference in the amount of blood/fluid transfused , postoperatively Hb , or RBC between the two groups .
-RESULTS	After the operation , coagulation parameters were not significantly different between the 2 groups at the days 1 or 3 postoperatively .
-RESULTS	No adverse events related to the use of Batroxobin were recorded .
-RESULTS	There were no cases of superficial wound infection .
-RESULTS	None of the subjects died during the study .
-CONCLUSIONS	In this study , prophylactic use of Batroxobin provided an effective and cheap method for reducing blood loss without coagulopathy during or after operations .
-CONCLUSIONS	The use of Batroxobin for patients undergoing one-level PLIF surgery safely and effectively reduced the total amount of perioperative blood loss .
-
-###24460069
-BACKGROUND	Physical activity during chemotherapy has been shown in several studies to reduce fatigue , improve symptoms and impact positively on health-related quality of life ( HRQoL ) .
-BACKGROUND	Challenges associated with intervention studies on physical activity during cancer treatment relate to consistent adherence .
-BACKGROUND	The primary objective was to study feasibility and adherence of physical activity intervention among patients with cancer during adjuvant chemotherapy treatment .
-BACKGROUND	The secondary objective was to investigate the effects of physical activity on health aspects , including HRQoL , symptoms and surrogate markers for cardiovascular disease .
-METHODS	This randomized controlled trial included patients with breast cancer ( BRCA ) and colorectal cancer ( CRC ) during adjuvant chemotherapy .
-METHODS	The intervention continued for 10 weeks and included daily walks of 10 000 steps and a weekly supervised group walk .
-METHODS	Adherence was assessed by a pedometer and the number of participants who reported step counts every week and percentage of participants who achieved the target steps every week .
-RESULTS	Adherence average reached 91 % during the intervention period ; in total 74 % completed the exercise intervention .
-RESULTS	The majority of the participants achieved an average of 83 % of the target of 10 000 steps per day for 10 weeks .
-RESULTS	There was a significant increase in daily physical activity ( p = 0.016 ) in the intervention group .
-RESULTS	Significant differences were also found for some breast cancer-specific symptoms [ swelling , mobility and pain ( p = 0.045 ) ] .
-RESULTS	The study showed a relatively small weight gain an average of 0.9 kg in the intervention group and 1.3 kg in the control group .
-CONCLUSIONS	Physical activity in the form of walking is feasible during adjuvant chemotherapy treatment despite increasing symptoms .
-CONCLUSIONS	The physical activity increased in the intervention group during the study time and had a positive impact on breast symptoms and the weight gain was lower in comparison to previous studies .
-
-###24469936
-BACKGROUND	The metabolism of alcohol and cognitive functions can vary during the menstrual cycle .
-BACKGROUND	Also , both alcohol ingestion and hormonal variations during menstruation have been associated with characteristic changes in electroencephalographic ( EEG ) activity .
-BACKGROUND	AIM .
-BACKGROUND	To determine whether EEG activity during a working memory task is affected by acute alcohol consumption , and if these EEG patterns vary in relation to different phases of the menstrual cycle .
-METHODS	24 women who drank a moderate dose of alcohol or placebo during the follicular and early luteal phases of the menstrual cycle .
-METHODS	The EEG activity was recorded during performance of viso-spatial working memory task .
-RESULTS	Although the alcohol did not deteriorate the performance of working memory task , it caused in the EEG a decrease of relative theta power and lower right fronto-parietal correlation in theta and alpha2 bands .
-RESULTS	Only women who drank alcohol in the follicular phase had a higher relative potency of alpha1 , which could indicate a lower level of arousal and attention .
-CONCLUSIONS	These results contribute to a better understanding of the brain mechanisms underlying cognitive changes with alcohol and its relationship to the menstrual cycle .
-
-###25203150
-BACKGROUND	A low glycemic index ( GI ) diet is beneficial for glucose control in patients with diabetes mellitus .
-BACKGROUND	This study aimed to investigate the influence of a low-GI diet on postprandial glucose levels in women with gestational diabetes mellitus ( GDM ) .
-METHODS	Pregnant women with GDM were randomized to receive a normal diabetic control diet or a low-GI staple diet for 5 days .
-METHODS	A low-GI staple food was used to replace rice in lunch and dinner for the low-GI staple diet group , whereas the total energy and carbohydrate levels remained equal in both groups .
-METHODS	Fasting and postprandial glucose levels were determined daily .
-RESULTS	A total of 140 pregnant women with GDM were included in the study , including 66 in the low-GI staple diet group and 74 in the normal diabetic diet control group .
-RESULTS	No differences existed in baseline characteristics between the 2 groups ( all P > 0.05 ) .
-RESULTS	After dietary intervention , glucose levels were significantly reduced in the low-GI staple diet group ( all P < 0.01 ) and the control group ( all P < 0.008 ) .
-RESULTS	Postintervention glucose values after breakfast , lunch , and dinner were significantly reduced in the treatment group compared with those in the control group ( all P < 0.05 ) .
-RESULTS	The percentage changes from baseline of all glucose values were significantly greater in the treatment group than in the control group ( all P < 0.05 ) .
-CONCLUSIONS	A low-GI staple diet significantly reduces postprandial glucose levels in women with GDM .
-
-###25271602
-BACKGROUND	The relationship between the risk of celiac disease and both the age at which gluten is introduced to a child 's diet and a child 's early dietary pattern is unclear .
-METHODS	We randomly assigned 832 newborns who had a first-degree relative with celiac disease to the introduction of dietary gluten at 6 months ( group A ) or 12 months ( group B ) .
-METHODS	The HLA genotype was determined at 15 months of age , and serologic screening for celiac disease was evaluated at 15 , 24 , and 36 months and at 5 , 8 , and 10 years .
-METHODS	Patients with positive serologic findings underwent intestinal biopsies .
-METHODS	The primary outcome was the prevalence of celiac disease autoimmunity and of overt celiac disease among the children at 5 years of age .
-RESULTS	Of the 707 participants who remained in the trial at 36 months , 553 had a standard-risk or high-risk HLA genotype and completed the study .
-RESULTS	At 2 years of age , significantly higher proportions of children in group A than in group B had celiac disease autoimmunity ( 16 % vs. 7 % , P = 0.002 ) and overt celiac disease ( 12 % vs. 5 % , P = 0.01 ) .
-RESULTS	At 5 years of age , the between-group differences were no longer significant for autoimmunity ( 21 % in group A and 20 % in group B , P = 0.59 ) or overt disease ( 16 % and 16 % , P = 0.78 by the log-rank test ) .
-RESULTS	At 10 years , the risk of celiac disease autoimmunity was far higher among children with high-risk HLA than among those with standard-risk HLA ( 38 % vs. 19 % , P = 0.001 ) , as was the risk of overt celiac disease ( 26 % vs. 16 % , P = 0.05 ) .
-RESULTS	Other variables , including breast-feeding , were not associated with the development of celiac disease .
-CONCLUSIONS	Neither the delayed introduction of gluten nor breast-feeding modified the risk of celiac disease among at-risk infants , although the later introduction of gluten was associated with a delayed onset of disease .
-CONCLUSIONS	A high-risk HLA genotype was an important predictor of disease .
-CONCLUSIONS	( Funded by the Fondazione Celiachia of the Italian Society for Celiac Disease ; CELIPREV ClinicalTrials.gov number , NCT00639444 . )
-
-###25217039
-BACKGROUND	Cardiovascular disease ( CVD ) is the leading cause of early death worldwide , responsible for an estimated 29 % of all global deaths .
-BACKGROUND	Reducing salt intake lowers blood pressure and risk of secondary cardiac events .
-BACKGROUND	However , identifying low salt foods can be challenging .
-BACKGROUND	SaltSwitch is a simple smartphone application ( app ) that enables shoppers to scan the barcode of packaged foods and receive an immediate , interpretive , traffic light nutrition label on the screen , along with suggestions for healthier lower-salt alternatives .
-BACKGROUND	A growing body of evidence suggests mobile technologies can support healthy behaviour change .
-BACKGROUND	However , robust evidence for the impact of smartphone interventions is lacking .
-BACKGROUND	This manuscript outlines the rationale and methods for a randomized controlled trial designed to determine the effectiveness of SaltSwitch in supporting people with CVD to make lower-salt food choices .
-METHODS	A 6-week , two-arm , parallel , randomized controlled trial is being undertaken in New Zealand ( 2weeks baseline and 4weeks intervention ) .
-METHODS	Three hundred adults aged 40years and older with CVD and their main household shoppers are recruited from research lists , cardiac rehabilitation clinics , and communities in Auckland .
-METHODS	Participants are randomized to receive either the SaltSwitch smartphone app or no intervention ( control ) .
-METHODS	Randomisation is stratified by ethnicity and age .
-METHODS	The primary outcome is the salt content of household food purchases .
-METHODS	Secondary outcomes are the saturated fat and energy content of household food purchases , household food expenditure , use and acceptability of the SaltSwitch app by shoppers , and urinary sodium and blood pressure of participants with CVD .
-METHODS	Ambulatory blood pressure and potential longer-term impact ( 12weeks ) of SaltSwitch will be assessed in sub-studies ( n ~ 40 and n ~ 20 , respectively ) .
-METHODS	Household purchases of salt and other nutrients will be assessed using till receipt data electronically linked with branded food composition data .
-CONCLUSIONS	The results of the SaltSwitch trial will determine the effectiveness , use and acceptability of a smartphone application to support lower salt food choices and secondary prevention of CVD .
-BACKGROUND	ACTRN12614000206628 .
-BACKGROUND	Registered 30 March 2014 .
-
-###24887579
-BACKGROUND	Prognostic models , such as the Seattle Heart Failure Model ( SHFM ) , have been developed to predict patient survival .
-BACKGROUND	The extent to which they predict medical resource use and costs has not been explored .
-BACKGROUND	In this study , we evaluated relationships between baseline SHFM scores and 1-year resource use and costs using data from a clinical trial .
-RESULTS	We applied generalized linear models to examine the relative impact of a 1-unit increase in SHFM scores on counts of medical resource use and direct medical costs at 1 year of follow-up .
-RESULTS	Of 2331 randomized patients , 2288 ( 98 % ) had a rounded integer SHFM score between -1 and 2 , consistent with predicted 1-year survival of 98 % and 74 % , respectively .
-RESULTS	At baseline , median age was 59 years , 28 % of patients were women , and nearly two-thirds of the cohort had New York Heart Association class II heart failure and one-third had class III heart failure .
-RESULTS	Higher SHFM scores were associated with more hospitalizations ( rate ratio per 1-unit increase , 1.86 ; P < .001 ) , more inpatient days ( 2.30 ; P < .001 ) , and higher inpatient costs ( 2.28 ; P < .001 ) , outpatient costs ( 1.54 ; P < .001 ) , and total medical costs ( 2.13 ; P < .001 ) .
-CONCLUSIONS	Although developed to predict all-cause mortality , SHFM scores also predict medical resource use and costs .
-
-###24846621
-BACKGROUND	Obesity-attributable medical expenditures remain high , and interventions that are both effective and cost-effective have not been adequately developed .
-BACKGROUND	The Opt-IN study is a theory-guided trial using the Multiphase Optimization Strategy ( MOST ) to develop an optimized , scalable version of a technology-supported weight loss intervention .
-OBJECTIVE	Opt-IN aims to identify which of 5 treatment components or component levels contribute most meaningfully and cost-efficiently to the improvement of weight loss over a 6 month period .
-METHODS	Five hundred and sixty obese adults ( BMI 30-40 kg/m ( 2 ) ) between 18 and 60 years old will be randomized to one of 16 conditions in a fractional factorial design involving five intervention components : treatment intensity ( 12 vs. 24 coaching calls ) , reports sent to primary care physician ( No vs. Yes ) , text messaging ( No vs. Yes ) , meal replacement recommendations ( No vs. Yes ) , and training of a participant 's self-selected support buddy ( No vs. Yes ) .
-METHODS	During the 6-month intervention , participants will monitor weight , diet , and physical activity on the Opt-IN smartphone application downloaded to their personal phone .
-METHODS	Weight will be assessed at baseline , 3 , and 6 months .
-CONCLUSIONS	The Opt-IN trial is the first study to use the MOST framework to develop a weight loss treatment that will be optimized to yield the best weight loss outcome attainable for $ 500 or less .
-
-###24669147
-OBJECTIVE	To compare the morphological ( cell density , coefficient of variation and standard deviation ) and functional ( central corneal thickness ) endothelial changes after phacoemulsification versus manual small-incision cataract surgery ( MSICS ) .
-METHODS	Prospective randomized control study .
-METHODS	In this prospective randomized control study , patients were randomly allocated to undergo phacoemulsification ( Group 1 , n = 100 ) or MSICS ( Group 2 , n = 100 ) using a random number Table .
-METHODS	The patients underwent complete ophthalmic evaluation and specular microscopy preoperatively and at 1and 6 weeks postoperatively .
-METHODS	Functional and morphological endothelial evaluation was Noncon ROBO PACHY SP-9000 specular microscope .
-METHODS	Phacoemulsification was performed , the chop technique and MSICS , by the viscoexpression technique .
-RESULTS	The mean difference in central corneal thickness at baseline and 1 week between Group 1 and Group 2 was statistically significant ( P = 0.027 ) .
-RESULTS	However , this difference at baseline when compared to 6 week and 1 week , 6 weeks was not statistically significant ( P > 0.05 ) .
-RESULTS	The difference in mean endothelial cell density between groups at 1 week and 6 weeks was statistically significant ( P = 0.016 ) .
-RESULTS	The mean coefficient of variation and mean standard deviation between groups were not statistically significant ( P > 0.05 , both comparisons ) .
-CONCLUSIONS	The central corneal thickness , coefficient of variation , and standard deviation were maintained in both groups indicating that the function and morphology of endothelial cells was not affected despite an initial reduction in endothelial cell number in MSICS .
-CONCLUSIONS	Thus , MSICS remains a safe option in the developing world .
-
-###24321164
-OBJECTIVE	Fatigue affects more than 60 % of multiple sclerosis ( MS ) patients and is one of the most troublesome symptoms of the disease .
-OBJECTIVE	Current treatment options for MS fatigue include amantadine , modafinil and acetyl-l-carnitine ( ALCAR ) .
-OBJECTIVE	The aim of our study was to compare efficacy of amantadine , modafinil and ALCAR with placebo in patients with MS.
-METHODS	Patients with MS and a disability level 5.5 on the Kurtzke Expanded Disability Status Scale ( EDSS ) and fatigue were included in the study .
-METHODS	Patients were assigned to a one month treatment with either amantadine 200mg , ALCAR 2g , modafinil 200mg or placebo .
-METHODS	Efficacy of the treatment was evaluated by using the modified fatigue impact scale ( MFIS ) .
-RESULTS	Sixty patients were included in the study ( 39 females ) .
-RESULTS	The mean age of patients was 38 6.7 years and the mean disease duration was 6.6 1.2 years .
-RESULTS	Contrast analysis showed significantly lower mean MFIS score after one month in patients on amantadine compared to placebo ( mean difference = 17.3 , p = 0.001 ) .
-RESULTS	There was also a trend of a lower MFIS score in ALCAR group in comparison to placebo ( mean difference = 12.4 , p = 0.05 , with Keppel-corrected alpha of 0.046 ) .
-RESULTS	The quality of life measured as SF 36 - PCS and SF 36 - MCS proved to be significantly influenced by treatment .
-CONCLUSIONS	One month treatment with amantadine improved fatigue in patients with relapsing-remitting MS as evaluated by MFIS .
-CONCLUSIONS	No or only a trend of improvement was seen in patients treated with modafinil or ALCAR , respectively .
-
-###25422826
-OBJECTIVE	To evaluate whether 5-mm short dental implants could be an alternative to augmentation with anorganic bovine bone and placement of at least 10-mm long implants in posterior atrophic jaws .
-METHODS	Fifteen patients with bilateral atrophic mandibles ( 5 mm to 7 mm bone height above the mandibular canal ) and 15 patients with bilateral atrophic maxillae ( 4 mm to 6 mm bone height below the maxillary sinus ) , and bone thickness of at least 8 mm , were randomised according to a split-mouth design to receive one to three 5-mm short implants or at least 10-mm long implants in augmented bone .
-METHODS	Mandibles were vertically augmented with interpositional bone blocks and maxillary sinuses with particulated bone via a lateral window .
-METHODS	Implants were placed after 4 months , submerged and loaded , after another 4 months , with provisional prostheses .
-METHODS	Four months later , definitive provisionally cemented prostheses were delivered .
-METHODS	Outcome measures were : prosthesis and implant failures ; any complication and peri-implant marginal bone level changes .
-RESULTS	In five augmented mandibles , the planned 10-mm long implants could not be placed and shorter implants ( 7 mm and 8.5 mm ) had to be used instead .
-RESULTS	Three years after loading , two patients , one treated in the mandible and one in the maxilla , dropped out .
-RESULTS	Three prostheses ( 1 mandibular and 2 maxillary ) failed in the short implant group versus none in the long implant group .
-RESULTS	In mandibles , one long implant failed versus two short implants in 1 patient .
-RESULTS	In maxillae , one long implant failed versus three short implants in 2 patients .
-RESULTS	There were no statistically significant differences in the failures .
-RESULTS	Eight patients had 13 complications at short implants ( 1 patient accounted for 6 complications ) and 11 patients had 13 complications at long implants .
-RESULTS	There were no statistically significant differences in complications ( P = 0.63 , difference = 0.10 , 95 % CI from -0.22 to 0.42 ) .
-RESULTS	Three years after loading , patients with mandibular implants lost on average 1.44 mm at short implants and 1.63 mm at long implants of peri-implant marginal bone .
-RESULTS	This difference was not statistically significant ( difference = 0.24 mm ; 95 % CI -0.01 , 0.49 P = 0.059 ) .
-RESULTS	In maxillae , patients lost on average 1.02 mm at short implants and 1.54 mm at long implants .
-RESULTS	This difference was statistically significant ( difference = 0.41 mm ; 95 % CI 0.21 , 0.60 , P = 0.001 ) .
-CONCLUSIONS	Three years after loading , 5-mm short implants achieved similar results as longer implants in augmented bone .
-CONCLUSIONS	Short implants might be a preferable choice to vertical bone augmentation , especially in mandibles , since the treatment is faster and cheaper , however there are still insufficient data on the long-term prognosis of short implants .
-
-###25010793
-OBJECTIVE	To examine the efficacy and safety of canagliflozin monotherapy , a sodium/glucose co-transporter 2 inhibitor , in Japanese type 2 diabetes patients .
-METHODS	In this double-blind , multi-centre Phase III study , patients aged 20 years with hemoglobin A1c ( HbA1c ) 7.0-10 .0 % on diet/exercise therapy alone received placebo or canagliflozin ( 100 or 200 mg ) once daily for 24 weeks .
-METHODS	The main outcome measure was the change in HbA1c from baseline to Week 24 .
-RESULTS	The changes in HbA1c ( -0.74 and -0.76 vs + 0.29 % ) , fasting plasma glucose ( 1 mg/dl = 0.0555 mmol/l ; -31.6 and -31.9 vs + 3.7 mg/dl ) , 2-h plasma glucose after 75-g glucose load ( -84.9 and -79.0 vs -0.5 mg/dl ) , body weight ( percent change : -3.76 and -4.02 vs -0.76 % ) and systolic blood pressure ( -7.88 and -6.24 vs -2.72 mmHg ) were significantly greater with 100 and 200 mg canagliflozin than with placebo ( all , p < 0.05 ) .
-RESULTS	Genital infections in females ( 6.5 , 6.3 and 0 % ) and asymptomatic hypoglycemia ( 4.4 , 5.6 and 2.2 % ) , but not symptomatic hypoglycemia ( 2.2 , 1.1 and 1.1 % ) , were more frequent in the 100 - and 200-mg groups than in the placebo group .
-CONCLUSIONS	Canagliflozin significantly improved glycemic control and was well tolerated .
-
-###25122977
-OBJECTIVE	To evaluate the efficacy of a marketed stabilized stannous fluoride ( SnF2 ) dentifrice in reducing dentinal hypersensitivity as compared to a marketed sodium fluoride ( NaF ) / triclosan dentifrice over an eight-week period .
-METHODS	Adults with confirmed dentinal hypersensitivity were enrolled in this randomized and controlled , parallel group , double blind , eight-week , single-center clinical trial .
-METHODS	Random assignment to one of two dentifrice test groups via age , gender , and thermal sensitivity of enrolled test teeth was performed at baseline , with subjects assigned to twice-daily unsupervised brushing with either the marketed SnF2 dentifrice ( Oral-B Pro-Expert , 0.454 % SnF2 plus 0.077 % NaF ) or the marketed 0.32 % NaF with 0.3 % triclosan/copolymer dentifrice control ( Colgate Total Advanced ) .
-METHODS	Tactile sensitivity ( Yeaple Probe ) and thermal sensitivity ( airblast/Schiff Air Index ) evaluations of the selected test teeth were performed at baseline pre-treatment , and again at Weeks 2 and 8 of product use to compare the dentifrices ' relative hypersensitivity protection effectiveness .
-RESULTS	Ninety-seven ( 97 ) of the 100 enrolled subjects completed the trial and were fully evaluable .
-RESULTS	At both Week 2 and Week 8 , for both the thermal and tactile evaluation measurements , subjects brushing with the marketed SnF2 dentifrice experienced statistically significantly ( p < 0.0001 ) superior average dentinal hypersensitivity improvement versus subjects assigned to the NaF/triclosan control dentifrice .
-RESULTS	Between groups , superior relative mean reduction in thermal Schiff Air Index favored SnF2 by 24 % at Week 2 and 68 % at Week 8 , while greater relative mean tactile Yeaple Probe benefits were observed for SnF2 relative to the control by 114 % after Week 2 and 184 % at Week 8 .
-RESULTS	The dentifrices were well-tolerated .
-CONCLUSIONS	Twice-daily brushing with a marketed SnF2 dentifrice provided superior dentinal hypersensitivity improvement versus a commercially available NaF/triclosan dentifrice , with significantly ( p < 0.0001 ) greater relief after two weeks , and even larger relative benefits at eight weeks .
-
-###24281461
-OBJECTIVE	Pediatric-onset Crohn disease is more aggressive than adult-onset disease , has high rates of resistance to existing drugs , and can lead to permanent impairments .
-OBJECTIVE	Few trials have evaluated new drugs for refractory Crohn disease in children .
-OBJECTIVE	To determine whether thalidomide is effective in inducing remission in refractory pediatric Crohn disease .
-METHODS	Multicenter , double-blind , placebo-controlled , randomized clinical trial of 56 children with active Crohn disease despite immunosuppressive treatment , conducted August 2008-September 2012 in 6 pediatric tertiary care centers in Italy .
-METHODS	Thalidomide , 1.5 to 2.5 mg/kg per day , or placebo once daily for 8 weeks .
-METHODS	In an open-label extension , nonresponders to placebo received thalidomide for an additional 8 weeks .
-METHODS	All responders continued to receive thalidomide for an additional minimum 52 weeks .
-METHODS	Primary outcomes were clinical remission at week 8 , measured by Pediatric Crohn Disease Activity Index ( PCDAI ) score and reduction in PCDAI by 25 % or 75 % at weeks 4 and 8 .
-METHODS	Primary outcomes during the open-label follow-up were clinical remission and 75 % response .
-RESULTS	Twenty-eight children were randomized to thalidomide and 26 to placebo .
-RESULTS	Clinical remission was achieved by significantly more children treated with thalidomide ( 13/28 [ 46.4 % ] vs 3/26 [ 11.5 % ] ; risk ratio [ RR ] , 4.0 [ 95 % CI , 1.2-12 .5 ] ; P = .01 ; number needed to treat [ NNT ] , 2.86 ) .
-RESULTS	Responses were not different at 4 weeks , but greater improvement was observed at 8 weeks in the thalidomide group ( 75 % response , 13/28 [ 46.4 % ] vs 3/26 [ 11.5 % ] ; RR , 4.0 [ 95 % CI , 1.2-12 .5 ] ; NNT = 2.86 ; P = .01 ; and 25 % response , 18/28 [ 64.2 % ] vs 8/26 [ 30.8 % ] ; RR , 2.1 [ 95 % CI , 1.1-3 .9 ] ; NNT = 2.99 ; P = .01 ) .
-RESULTS	Of the nonresponders to placebo who began receiving thalidomide , 11 of 21 ( 52.4 % ) subsequently reached remission at week 8 ( RR , 4.5 [ 95 % CI , 1.4-14 .1 ] ; NNT = 2.45 ; P = .01 ) .
-RESULTS	Overall , 31 of 49 children treated with thalidomide ( 63.3 % ) achieved clinical remission , and 32 of 49 ( 65.3 % ) achieved 75 % response .
-RESULTS	Mean duration of clinical remission in the thalidomide group was 181.1 weeks ( 95 % CI , 144.53-217 .76 ) vs 6.3 weeks ( 95 % CI , 3.51-9 .15 ) in the placebo group ( P < .001 ) .
-RESULTS	Cumulative incidence of severe adverse events was 2.1 per 1000 patient-weeks , with peripheral neuropathy the most frequent severe adverse event .
-CONCLUSIONS	In children and adolescents with refractory Crohn disease , thalidomide compared with placebo resulted in improved clinical remission at 8 weeks of treatment and longer-term maintenance of remission in an open-label follow-up .
-CONCLUSIONS	These findings require replication to definitively determine clinical utility of this treatment .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00720538 .
-
-###25336596
-BACKGROUND	The effects of electronic health records ( EHRs ) on doctor-patient communication are unclear .
-OBJECTIVE	To evaluate the effects of EHR use compared with paper chart use , on novice physicians ' communication skills .
-METHODS	Within-subjects randomized controlled trial using observed structured clinical examination methods to assess the impact of use of an EHR on communication .
-METHODS	A large academic internal medicine training program .
-METHODS	First-year internal medicine residents .
-METHODS	Residents interviewed , diagnosed , and initiated treatment of simulated patients using a paper chart or an EHR on a laptop computer .
-METHODS	Video recordings of interviews were rated by three trained observers using the Four Habits scale .
-RESULTS	Thirty-two residents completed the study and had data available for review ( 61.5 % of those enrolled in the residency program ) .
-RESULTS	In most skill areas in the Four Habits model , residents performed at least as well using the EHR and were statistically better in six of 23 skills areas ( p < 0.05 ) .
-RESULTS	The overall average communication score was better when using an EHR : mean difference 0.254 ( 95 % CI 0.05 to 0.45 ) , p = 0.012 , Cohen 's d of 0.47 ( a moderate effect ) .
-RESULTS	Residents scoring poorly ( > 3 average score ) with paper methods ( n = 8 ) had clinically important improvement when using the EHR .
-CONCLUSIONS	This study was conducted in first-year residents in a training environment using simulated patients at a single institution .
-CONCLUSIONS	Use of an EHR on a laptop computer appears to improve the ability of first-year residents to communicate with patients relative to using a paper chart .
-
-###25146960
-BACKGROUND	There is abundant research indicating poor physical , psychological , and social functioning of patients with chronic heart failure ( HF ) , a reality that can lead to poor health-related quality of life ( QoL ) .
-BACKGROUND	Little is known about the experience of rural patients with HF .
-RESULTS	This study was part of a randomized clinical trial titled Rural Education to Improve Outcomes in Heart Failure ( REMOTE-HF ) designed to test an education and counseling intervention to improve self-care in patients with HF .
-RESULTS	We evaluated 612 rural patients .
-RESULTS	Multiple validated questionnaires were administered to assess patient perceptions of health and health literacy .
-RESULTS	Baseline factors were collected and compared with baseline QoL measures only .
-RESULTS	Patients ' health-related QoL was assessed using the Minnesota Living with Heart Failure scale .
-RESULTS	The data were analyzed using a general linear model to test the association of various patient characteristics with QoL in rural patients with HF .
-RESULTS	Patients were 65.8 ( +12.9 ) years of age .
-RESULTS	The majority were men ( 58.7 % ) , married ( 56.4 % ) , and had completed a high-school education ( 80.9 % ) .
-RESULTS	Factors associated with reduced QoL among this population include geographic location , younger age , male sex , higher New York Heart Association class , worse HF knowledge , poorer perceived control , and symptoms of depression or anxiety .
-RESULTS	The data provided no evidence of an association between left ventricular ejection fraction and QoL .
-CONCLUSIONS	This study of rural patients with HF confirms previously identified factors associated with perceptions of QoL .
-CONCLUSIONS	However , further study is warranted with an urban control group .
-BACKGROUND	http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00415545 .
-
-###24731671
-BACKGROUND	Eprotirome is a liver-selective thyroid hormone receptor agonist that has been shown to lower plasma LDL cholesterol concentrations in previous phase 1 and 2 studies of patients with dyslipidaemia .
-BACKGROUND	We aimed to assess the long-term safety and efficacy of 50 g and 100 g eprotirome in patients with familial hypercholesterolaemia .
-METHODS	For this randomised , double-blind , placebo-controlled , parallel-group , phase 3 clinical trial , we enrolled patients between Oct 3 , 2011 , and Feb 14 , 2012 , at 53 sites in 11 countries in Europe , Africa , and south Asia .
-METHODS	Patients were eligible for enrolment if they were aged 18 years or older , diagnosed with heterozygous familial hypercholesterolaemia , and had not reached target LDL cholesterol concentrations after at least 8 weeks of statin therapy with or without ezetimibe .
-METHODS	We used a computer-generated randomisation sequence to allocate patients to one of three groups : 50 g eprotirome , 100 g eprotirome , or placebo .
-METHODS	This trial was planned for 52-76 weeks , with primary efficacy analysis at 12 weeks , but it was prematurely terminated when another study found that eprotirome causes cartilage damage in dogs .
-METHODS	Although it was impossible to meet the predefined study outcomes , we analysed changes in the concentrations of LDL cholesterol and other lipids , liver parameters , thyroid hormone concentrations , and adverse effects of treatment with eprotirome versus placebo at 6 weeks of treatment .
-METHODS	Analysis was done in all patients who received 6 weeks of treatment .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01410383 .
-RESULTS	We enrolled 236 patients , randomly allocating 80 to receive placebo , 79 to receive 50 g eprotirome , and 77 to receive 100 g eprotirome .
-RESULTS	69 patients reached the 6 week timepoint ( 23 given placebo , 24 given 50 g eprotirome , and 22 given 100 g eprotirome ) .
-RESULTS	Mean LDL cholesterol concentrations increased by 9 % ( 95 % CI -2 to 20 ) in the placebo group , decreased by 12 % ( -28 to 4 % ; p = 0.0677 vs placebo ) in the 50 g eprotirome group , and decreased by 22 % ( -32 to -13 % ; p = 0.0045 vs placebo ) in the 100 g eprotirome group .
-RESULTS	We noted statistically significant increases between both eprotirome groups and placebo in aspartate aminotransferase ( AST ; p < 0.0001 ) , alanine aminotransferase ( ALT ; p < 0.0001 ) , conjugated bilirubin ( p = 0.0006 ) , and gamma-glutamyltranspeptidase ( p < 0.0001 ) .
-RESULTS	Four patients had to discontinue or interrupt study treatment before trial termination due to AST increases between the upper limit of normal ( ULN ) and six times ULN , and ALT concentrations between three and seven times ULN .
-RESULTS	Although we detected no changes in serum concentrations of thyroid-stimulating hormone or free tri-iodothyronine , free tetra-iodothyronine decreased by 19 % ( 23 to 16 ) in the 50 g eprotirome group and 27 % ( 30 to 23 ) in the 100 g eprotirome group ( p < 0.0001 vs placebo for both groups ) .
-CONCLUSIONS	Our findings show that eprotirome can lower LDL cholesterol concentrations in patients with familial hypercholesterolaemia when added to conventional statin treatment with or without ezetimibe , but that it has the potential to induce liver injury .
-CONCLUSIONS	These findings , along with findings of cartilage damage in dogs , raise serious doubts about selective thyroid hormone mimetics as a therapeutic approach to lower LDL cholesterol concentrations .
-BACKGROUND	Karo Bio AB .
-
-###25828636
-OBJECTIVE	The aim of the present study was to compare the pharmacokinetic profiles between a new generic and a branded reference formulation of irbesartan / hydrochlorothiazide FDC tablets , and to assess the bioequivalence of the two products in healthy Chinese male volunteers .
-METHODS	24 male healthy volunteers participated in the open-label , single-dose , randomized-sequence , 2-way crossover study .
-METHODS	Eligible subjects were randomly assigned ( 1:1 ) to receive a single 300/12 .5 - mg dose of either the test or reference formulation followed by a 1-week washout .
-METHODS	Blood samples were obtained before ( 0 hours ) and 0.5 , 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 24 , 36 , 48 , and 72 hours after dosing .
-METHODS	Plasma concentrations of irbesartan and hydrochlorothiazide were analyzed by two separate validated liquid chromatography/tandem mass spectrometric ( LC-MS/MS ) methods .
-RESULTS	For irbesartan , the 90 % confidence intervals ( CIs ) of AUC0-t , AUC0 - , and Cmax were 103.27-116 .71 % , 105.01-121 .47 % , and 84.15-96 .88 % , respectively .
-RESULTS	For hydrochlorothiazide , the 90 % CIs of AUC0-t , AUC0 - , and Cmax were 96.11-109 .02 % , 95.15-107 .35 % , and 91.66-101 .40 % , respectively .
-RESULTS	A total of 3 mild AEs were reported in 3 subjects ( 12.5 % ) .
-CONCLUSIONS	In this study , a single dose ( 300/12 .5 - mg ) of the test formulation of irbesartan and hydrochlorothiazide FDC tablet in fasting healthy Chinese male volunteers met WHO 's and China 's FDA regulatory criteria for assumption of bioequivalence to the reference formulation based on AUC and Cmax .
-CONCLUSIONS	Both formulations were well tolerated .
-
-###25711329
-OBJECTIVE	Both HIV infection and antiretroviral therapy ( ART ) may increase cardiovascular disease ( CVD ) risk .
-OBJECTIVE	Assessments of vascular function and structure can be used to study the pathogenesis and progression of CVD , including the effects of ART and other interventions .
-OBJECTIVE	The objective of this report is to understand methods to assess vascular ( dys ) function and report our experience in the Arterial Elasticity Substudy in the Strategic Timing of AntiRetroviral Treatment ( START ) trial .
-METHODS	We review literature and analyze baseline data from the Arterial Elasticity Substudy , which estimated vascular ( dys ) function through analysis of the diastolic blood pressure ( BP ) waveform .
-METHODS	Linear regression was used to study cross-sectional associations between baseline clinical factors and small or large arterial elasticity .
-RESULTS	Arterial elasticity measurement was chosen for its improved measurement reproducibility over other methodologies and the potential of small arterial elasticity to predict clinical risk .
-RESULTS	Analysis of baseline data demonstrates that small artery elasticity is impaired ( lower ) with older age and differs by race and between geographical regions .
-RESULTS	No HIV-specific factors studied remained significantly associated with arterial elasticity in multivariate models .
-CONCLUSIONS	Longitudinal analyses in this substudy will provide essential randomized data with which to study the effects of early ART initiation on the progression of vascular disease among a diverse global population .
-CONCLUSIONS	When combined with future biomarker analyses and clinical outcomes in START , these findings will expand our understanding of the pathogenesis of HIV-related CVD .
-
-###24854041
-OBJECTIVE	To determine whether impaired awareness of hypoglycemia ( IAH ) can be improved and severe hypoglycemia ( SH ) prevented in type 1 diabetes , we compared an insulin pump ( continuous subcutaneous insulin infusion [ CSII ] ) with multiple daily injections ( MDIs ) and adjuvant real-time continuous glucose monitoring ( RT ) with conventional self-monitoring of blood glucose ( SMBG ) .
-METHODS	A 24-week 2 2 factorial randomized controlled trial in adults with type 1 diabetes and IAH was conducted .
-METHODS	All received comparable education , support , and congruent therapeutic targets aimed at rigorous avoidance of biochemical hypoglycemia without relaxing overall control .
-METHODS	Primary end point was between-intervention difference in 24-week hypoglycemia awareness ( Gold score ) .
-RESULTS	A total of 96 participants ( mean diabetes duration 29 years ) were randomized .
-RESULTS	Overall , biochemical hypoglycemia ( 3.0 mmol/L ) decreased ( 53 63 to 24 56 min/24 h ; P = 0.004 [ t test ] ) without deterioration in HbA1c .
-RESULTS	Hypoglycemia awareness improved ( 5.1 1.1 to 4.1 1.6 ; P = 0.0001 [ t test ] ) with decreased SH ( 8.9 13.4 to 0.8 1.8 episodes/patient-year ; P = 0.0001 [ t test ] ) .
-RESULTS	At 24 weeks , there was no significant difference in awareness comparing CSII with MDI ( 4.1 1.6 vs. 4.2 1.7 ; difference 0.1 ; 95 % CI -0.6 to 0.8 ) and RT with SMBG ( 4.3 1.6 vs. 4.0 1.7 ; difference -0.3 ; 95 % CI -1.0 to 0.4 ) .
-RESULTS	Between-group analyses demonstrated comparable reductions in SH , fear of hypoglycemia , and insulin doses with equivalent HbA1c .
-RESULTS	Treatment satisfaction was higher with CSII than MDI ( 32 3 vs. 29 6 ; P = 0.0003 [ t test ] ) , but comparable with SMBG and RT ( 30 5 vs. 30 5 ; P = 0.79 [ t test ] ) .
-CONCLUSIONS	Hypoglycemia awareness can be improved and recurrent SH prevented in long-standing type 1 diabetes without relaxing HbA1c .
-CONCLUSIONS	Similar biomedical outcomes can be attained with conventional MDI and SMBG regimens compared with CSII/RT , although satisfaction was higher with CSII .
-
-###25185456
-BACKGROUND	Cold hands sensation is a common disorder within the Korean population .
-BACKGROUND	Many Korean family physicians believe that it is a mild early manifestation of Raynaud 's phenomenon ( RP ) , or may be related to RP .
-BACKGROUND	RP is characterized by reversible digital vasospasm provoked by cold temperatures and/or emotional stress , and doctors often prescribe medications that are used in treatment of RP for subjects with cold hands .
-BACKGROUND	However , this has not shown a clear benefit , and these medications can cause unwanted side effects .
-BACKGROUND	It is also reported that traditional Korean medicine , including acupuncture , is widely used to treat cold hands , although the current level of evidence for this approach is also poor and to date , there have been no published randomized controlled clinical trials ( RCTs ) evaluating the efficacy and safety of acupuncture for cold hands .
-BACKGROUND	We have therefore designed a pilot RCT to obtain information for the design of a further full-scale trial .
-METHODS	The proposed study is a five-week pilot RCT .
-METHODS	A total of 14 subjects will be recruited and randomly allocated to two groups : an acupuncture plus medication group ( experimental group ) and a medication-only group ( control group ) .
-METHODS	All subjects will take nifedipine ( 5 mg once daily ) and beraprost ( 20 mg three times daily ) for three weeks .
-METHODS	The experimental group will receive additional treatment with three acupuncture sessions per week for three weeks ( nine sessions total ) .
-METHODS	The primary outcome will be measured using a visual analogue scale .
-METHODS	Secondary outcomes will be measured by blood perfusion in laser Doppler perfusion imaging of the hands , frequency and duration of episodes of cold hands , and heart rate variability .
-METHODS	Assessments will be made at baseline and at one , three , and five weeks thereafter .
-CONCLUSIONS	This study will provide an indication of the feasibility and a clinical foundation for a future large-scale trial .
-BACKGROUND	This study was registered at Korean Clinical Research Information Service ( CRIS ) registry on 5 August 2013 with the registration number #KCT 0000817 .
-
-###25932700
-BACKGROUND	Elevating the hospital head of bed ( HOB ) to at least 30 is recommended practice to reduce the risk of ventilator-associated pneumonia ( VAP ) in mechanically ventilated patients .
-BACKGROUND	However , this common practice prescribes the position of the bed and not of the patient , which could be significantly different .
-OBJECTIVE	The aim of this research was to determine the relationship between patient migration in bed and anatomic torso angle .
-METHODS	Ten healthy participants were positioned in a hospital bed that was raised from flat to 30 and 45 HOB elevations .
-METHODS	Prior to bed movement , participants were aligned to different locations along the length of the bed to represent different amounts of migration .
-METHODS	A motion capture system was used to measure torso angle and migration toward the foot of the bed .
-METHODS	The relationship between torso angle and migration was estimated by linear regression .
-RESULTS	Patient migration resulted in lower torso angles for both 30 and 45 HOB articulations .
-RESULTS	A migration of 10 cm resulted in a loss of 9.1 and 13.0 of torso angle for HOB articulations of 30 and 45 , respectively ( for 30 articulations : ( Equation is included in full-text article . )
-RESULTS	= -0.91 , R = .96 ; for 45 articulations : ( Equation is included in full-text article . )
-RESULTS	= -1.30 , R = .98 ) .
-CONCLUSIONS	Migration toward the foot of the bed flattens the torso .
-CONCLUSIONS	To maintain a torso angle that is likely to protect against VAP , healthcare providers need to manage both HOB angle and migration .
-CONCLUSIONS	Protocols and equipment that minimize patient migration will help support effective clinical practice .
-CONCLUSIONS	Future research on patient migration , as it relates to VAP or other outcomes , should measure patient torso angle to allow accurate translation of the results to care practice .
-
-###24821885
-OBJECTIVE	This two-stage phase IB study investigated the pharmacokinetics and safety of subcutaneous ( SC ) versus intravenous ( IV ) administration of rituximab as maintenance therapy in follicular lymphoma .
-METHODS	In stage 1 ( dose finding ) , 124 patients who responded to rituximab induction were randomly assigned to SC rituximab ( 375 mg/m2 , 625 mg/m2 , or an additional group at 800 mg/m2 ) or IV rituximab ( 375 mg/m2 ) .
-METHODS	The objective was to determine an SC dose that would yield a rituximab serum trough concentration ( Ctrough ) in the same range as that of IV rituximab .
-METHODS	In stage 2 , 154 additional patients were randomly assigned ( 1:1 ) to SC rituximab ( 1,400 mg ) or IV rituximab ( 375 mg/m2 ) given at 2 - or 3-month intervals .
-METHODS	The objective was to demonstrate noninferior rituximab Ctrough of SC rituximab relative to IV rituximab 375 mg/m2 .
-RESULTS	Stage 1 data predicted that a fixed dose of 1,400 mg SC rituximab would result in a serum Ctrough in the range of that of IV rituximab .
-RESULTS	Noninferiority ( ie , meeting the prespecified 90 % CI lower limit of 0.8 ) was then confirmed in stage 2 , with geometric mean Ctrough SC : Ctrough IV ratios for the 2 - and 3-month regimens of 1.24 ( 90 % CI , 1.02 to 1.51 ) and 1.12 ( 90 % CI , 0.86 to 1.45 ) , respectively .
-RESULTS	Overall safety profiles were similar between formulations ( in stage 2 , 79 % of patients experienced one or more adverse events in each group ) .
-RESULTS	Local administration-related reactions ( mainly mild to moderate ) occurred more frequently after SC administration .
-CONCLUSIONS	The fixed dose of 1,400 mg SC rituximab predicted by using stage 1 results was confirmed to have noninferior Ctrough levels relative to IV rituximab 375 mg/m2 dosing during maintenance , with a comparable safety profile .
-CONCLUSIONS	Additional investigation will be required to determine whether the SC route of administration for rituximab provides equivalent efficacy compared with that of IV administration .
-
-###25476698
-BACKGROUND	Myopia is a public health problem worldwide and its incidence increases with age .
-BACKGROUND	The use of acupuncture to treat myopia is a common practice in China , however , the use of acupuncture to treat myopia is disputed in other parts of the world .
-BACKGROUND	This study aims to determine the safety of acupuncture to treat myopia and its efficacy over six months .
-METHODS	A randomized , parallel , single-center , assessor - and statistician-blinded , controlled clinical trial will be performed .
-METHODS	A total of 100 teenagers , between seven and 12 years of age , with mild-to-moderate myopia and spherical lenses < -6.00 D and cylindrical lenses < -1.50 D will be selected from the Xinjiang Uygur Autonomous Region Institute of Traditional Chinese Medicine , a grade III level A teaching hospital in Urumqi , Xinjiang , China ( Xinjiang Medical University Affiliated Hospital of Traditional Medicine ) .
-METHODS	The subjects will be randomly assigned to two different groups ( control and acupuncture groups ) , each group containing 50 subjects .
-METHODS	The subjects in both groups wear single-vision corrective lenses .
-METHODS	In the acupuncture group , acupuncture will be performed daily for nine consecutive days on five points ( bilateral Cuanzhu , Tongziliao , Sibai , Muchuang , and Hegu ) , followed by no treatment for one day .
-METHODS	Six cycles of treatment will be undertaken continuously for a total of 60 days .
-METHODS	Following 60 days of treatment , a follow-up period of six months will be included .
-METHODS	The primary outcome will be diopter determination .
-METHODS	The secondary outcomes will include distance visual acuity , axial length , lens thickness , ciliary body thickness , and subjective symptoms of the eyes and entire body .
-METHODS	The main time points for the evaluation of clinical efficacy will be the first , third , and sixth months after treatment .
-CONCLUSIONS	This study will provide clinical observations of various indices following the use of acupuncture to treat adolescents with mild-to-moderate myopia , as well as information on the safety of acupuncture .
-BACKGROUND	Chinese Clinical Trial Registry ( identifier : ChiCTR-TRC-13003448 ; registration date : 7 August 2013 ) .
-
-###25707477
-OBJECTIVE	Interleukin-20 ( IL-20 ) is implicated in the pathogenesis of rheumatoid arthritis ( RA ) .
-OBJECTIVE	The efficacy , safety , and tolerability of NNC0109-0012 , a selective anti-IL-20 recombinant human monoclonal antibody ( mAb ) , were assessed in patients with active RA who had an inadequate response to methotrexate therapy .
-METHODS	Sixty-seven patients with RA were enrolled and randomized ( 2:1 ) to receive NNC0109-0012 ( 3 mg/kg per week , subcutaneously ) or placebo in a phase IIa , double-blind , 12-week trial with a 13-week followup .
-METHODS	The primary end point was change in the Disease Activity Score in 28 joints based on C-reactive protein level ( DAS28-CRP ) from baseline to week 12 .
-RESULTS	In patients treated with NNC0109-0012 , the primary end point , improvement in the DAS28-CRP at week 12 , was achieved ( estimated difference -0.88 ; P = 0.02 ) , with significant improvement starting at week 1 .
-RESULTS	A greater response was observed in seropositive patients ( estimated difference -1.66 ; P < 0.001 ) , which was sustained through 13 weeks of followup , whereas no improvement was noted in patients with seronegative RA .
-RESULTS	A significant proportion of patients with seropositive RA receiving NNC0109-0012 , compared to those receiving placebo , achieved treatment responses according to the American College of Rheumatology 20 % ( ACR20 ) ( 59 % versus 21 % ) , ACR50 ( 48 % versus 14 % ) , and ACR70 ( 35 % versus 0 % ) levels of improvement , and showed greater improvements in the Health Assessment Questionnaire disability index ( P = 0.047 ) .
-RESULTS	The most frequent adverse events reported with NNC0109-0012 were injection site reactions and infections ( e.g. , herpes , nasopharyngitis , respiratory , and urinary ) .
-RESULTS	No serious infections or discontinuations associated with NNC0109-0012 were observed .
-CONCLUSIONS	In this phase IIa trial , treatment with NNC0109-0012 ( anti-IL-20 mAb ) was effective in patients with seropositive RA as early as week 1 , with further improvements to week 12 .
-CONCLUSIONS	No safety or tolerability concerns were identified with weekly NNC0109-0012 administration .
-
-###25079863
-BACKGROUND	Lanthanum carbonate ( LC ) , an effective non-calcium phosphate binder is widely used to manage hyperphosphatemia in patients with chronic kidney disease ( CKD ) on dialysis .
-BACKGROUND	Recently , the additional indication for control of hyperphosphatemia in CKD patients not on dialysis has been approved .
-METHODS	A multicenter , randomized , double-blind , placebo-controlled trial to confirm the efficacy and safety of LC in Japanese hyperphosphatemic stage 4 - 5 CKD patients not on dialysis .
-METHODS	After a 4-week run-in period , 143 eligible subjects with serum phosphate levels of 5.6 - 11.0 mg/dL were randomized ( 2 : 1 ) to receive LC or placebo ( 88 vs. 55 ) for 8 weeks ; 119 subjects completed the study ( 76 vs. 43 ) .
-METHODS	The starting LC dose was 750 mg/day , which was then up-titrated to 2,250 mg/day as needed while tolerated .
-METHODS	Primary efficacy analysis was performed on the intent-to-treat ( ITT ) population of 141 patients ( 86 vs. 55 ) .
-RESULTS	LC produced a significantly greater reduction in serum phosphate level compared with placebo after 8 weeks of treatment ( difference , 0.97 ( 95 % CI : 0.58 , 1.37 ) mg / dL ; p < 0.0001 ) .
-RESULTS	The cumulative proportion of subjects with controlled phosphate levels 4.6 mg/dL was higher in the LC group than the placebo group ( 59.56 % vs. 10.46 % ) .
-RESULTS	LC caused significantly greater reductions in serum Ca P product and urinary phosphate excretion compared with placebo .
-RESULTS	The safety profile of LC was similar to that of placebo .
-CONCLUSIONS	This study demonstrated the effectiveness of LC to control hyperphosphatemia in pre-dialysis CKD patients .
-
-###24366852
-BACKGROUND	The objective of this study was to assess the effect of a yoga intervention on psychological health in older adults .
-METHODS	A randomized controlled trial study , conducted at 2 North Florida facilities for older adults .
-METHODS	Subjects were 98 older adults , ages 65 to 92 .
-METHODS	Participants were randomly assigned to chair yoga , chair exercise , and control groups and assessed preintervention , postintervention , and 1-month follow-up on the State Anger Expression Inventory , State Anxiety Inventory , Geriatric Depression Scale , Lawton 's PGC Morale Scale , General Self-Efficacy Scale , Chronic Disease Self-Efficacy Scales , and Self - Control Schedule .
-RESULTS	Yoga participants improved more than both exercise and control participants in anger ( Cohen 's d = 0.89 for yoga versus exercise , and 0.90 for yoga versus control , pretest to posttest ; and d = 0.90 and 0.72 , pretest to follow-up ) , anxiety ( d = 0.27 , 0.39 and 0.62 , 0.63 ) , depression ( d = 0.47 , 0.49 and 0.53 , 0.51 ) , well-being ( d = 0.14 , 0.49 and 0.25 , 0.61 ) , general self-efficacy ( d = 0.63 , 1.10 and 0.30 , 0.85 ) , and self-efficacy for daily living ( d = 0.52 , 0.81 and 0.27 , 0.42 ) .
-RESULTS	Changes in self-control moderated changes in psychological health .
-CONCLUSIONS	Over a 6-week period , our findings indicate yoga 's potential for improving psychological health in older adults .
-
-###24573620
-OBJECTIVE	To analyze the incidence of surgical site infection when the preoperative skin preparation was performed with 10 % povidone-iodine and 0.5 % chlorhexidine-alcohol .
-METHODS	We conducted a randomized , longitudinal study based on variables obtained from patients undergoing clean and potentially contaminated operations .
-METHODS	Those involved were divided into two groups .
-METHODS	In group 1 ( G1 ) we included 102 patients with skin prepared with povidone-iodine , and in group 2 ( G2 ) , 103 , whose skin was prepared with chlorhexidine .
-METHODS	In the third , seventh and 30th postoperative days we evaluated the surgical site , searching for signs of infection .
-RESULTS	Data related to clinical profile , such as diabetes mellitus , smoking , alcoholism , haematological data ( Hb , VG and leukocytes ) , age and gender , and the related variables , such as number of days of preoperative hospitalization , shaving , topography of incision , antibiotic prophylaxis and resident participation in the operation were not predisposing factors for surgical site infection .
-RESULTS	Two patients in G1 and eight in G2 undergoing clean operations had some type of infection ( p = 0.1789 ) , five in G1 and three in G2 undergoing potentially contaminated operations had some type of infection ( p = 0.7205 ) .
-CONCLUSIONS	The incidence of surgical site infection in operations classified as clean and as potentially contaminated for which skin preparation was done with 10 % povidone-iodine and 0.5 % chlorhexidine-alcohol was similar .
-
-###24752957
-OBJECTIVE	We report the efficacy and safety of levofloxacin versus rifampicin in tuberculous meningitis ( TBM ) .
-METHODS	In this open-label , randomized controlled trial from India , patients with TBM diagnosed on the basis of clinical , MRI and CSF findings were included .
-METHODS	Patients with hepatic or renal dysfunction , organ transplantation , malignancy , pregnancy , lactation , allergy , seizure , age < 15 years and antitubercular treatment 1 month were excluded .
-METHODS	Sixty patients each were randomized to levofloxacin ( 10 mg/kg , maximum 500 mg ) or rifampicin ( 10 mg/kg , maximum 450 mg ) .
-METHODS	They also received isoniazid , pyrazinamide , ethambutol , prednisolone and aspirin .
-METHODS	The primary outcome was death and secondary outcome measures were 6 month disability , repeat MRI changes and serious adverse events ( SAEs ) .
-RESULTS	The median age of the patients was 34.5 ( 16-75 ) years .
-RESULTS	The baseline clinical and MRI findings were similar between the two groups .
-RESULTS	At 6 months , 13 out of 60 ( 21.7 % ) patients in the levofloxacin arm and 23 out of 60 ( 38.3 % ) patients in the rifampicin arm had died ( P = 0.07 ) .
-RESULTS	On Cox regression analysis , survival in the levofloxacin group was significantly better than in the rifampicin group ( hazard ratio 2.13 , 95 % CI 1.04-4 .34 , P = 0.04 ) .
-RESULTS	The functional outcome ( P = 0.47 ) was , however , not significantly different between the two groups .
-RESULTS	On intention-to-treat analysis , 10 out of 47 ( 21.3 % ) in the levofloxacin arm and 5 out of 37 ( 13.5 % ) in the rifampicin arm had poor recovery .
-RESULTS	Repeat MRI findings did not differ between the groups .
-RESULTS	Levofloxacin was discontinued more frequently than rifampicin due to SAEs ( 16 versus 4 , P = 0.01 ) .
-CONCLUSIONS	Levofloxacin is superior to rifampicin in reducing 6 month death in TBM but not disability .
-CONCLUSIONS	Levofloxacin may be used in TBM especially in those patients with hepatotoxicity and without seizure .
-
-###24257390
-BACKGROUND	Neuromuscular blocking drugs have been implicated in intraoperative bronchoconstrictive episodes .
-BACKGROUND	We examined the effects of clinically relevant doses of cisatracurium and rocuronium on the lung mechanics of pediatric subjects .
-BACKGROUND	We hypothesized that cisatracurium and rocuronium would have bronchoconstrictive effects .
-METHODS	We studied ASA physical status I and II pediatric subjects having elective dental or urological procedures , requiring general anesthesia with endotracheal intubations with either cisatracurium or rocuronium .
-METHODS	Pulmonary function tests were performed before and after neuromuscular blocking drug dosing and again after albuterol administration .
-METHODS	Using forced deflation and passive deflation techniques , forced vital capacity ( FVC ) and maximum expiratory flow rate at 10 % ( MEF10 ) of FVC were obtained .
-METHODS	Fractional changes from the baseline were used to compare subjects .
-METHODS	Changes in MEF10 of > 30 % were considered clinically significant .
-METHODS	A Shapiro-Wilk test , paired t test , and Wilcoxon rank sum test were used to analyze the data .
-RESULTS	Twenty-five subjects ( median age = 5.25 years ; range = 9 months-9 .9 years ) were studied ; 12 subjects received cisatracurium and 13 subjects received rocuronium .
-RESULTS	Data are shown as mean proportional change SD or , in the case of not normally distributed , median proportional change ( first , third quartile ) with P values .
-RESULTS	In the cisatracurium group , there were no differences between baseline and postneuromuscular blocker administration in the fractional change from the baselines of FVC ( 1.00 0.04 , P = 0.5 ) , but there was a significant decrease in MEF10 ( 0.80 0.18 , P = 0.002 ) .
-RESULTS	In the rocuronium group , there were small yet significant decreases of FVC ( 0.99 [ first quartile 0.97 , third quartile 1 ] , P = 0.02 ) and significant decreases in MEF10 ( 0.78 0.26 , P = 0.008 ) .
-RESULTS	After administration of albuterol in the cisatracurium group , FVC increased slightly but significantly from baseline values ( 1.02 0.02 , P = 0.005 ) .
-RESULTS	MEF10 increased significantly beyond baseline values ( 1.24 0.43 , P = 0.04 ) .
-RESULTS	In the rocuronium group , there were also significant differences between baseline and postalbuterol administration from the baseline value of FVC ( 1.02 0.02 , P = 0.004 ) and MEF10 ( 1.23 0.29 , P = 0.01 ) .
-CONCLUSIONS	At clinically relevant doses , both cisatracurium and rocuronium caused changes in lung function , indicating constriction of smaller airways .
-CONCLUSIONS	In general , these changes were mild and not clinically detectable .
-CONCLUSIONS	However , in the rocuronium group , 3 of 13 patients showed more noticeable decreases in MEF10 ( 50 % ) , demonstrating the potential for significant broncho-bronchiolar constriction in susceptible patients .
-
-###25104617
-BACKGROUND	In the PARAMOUNT ( `` A Phase 3 , Double-Blind , Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care vs. Best Supportive Care Immediately Following Induction Treatment with Pemetrexed Plus Cisplatin for Advanced Non-Squamous Non-Small-Cell Lung Cancer '' ) trial , patients with advanced nonsquamous non-small-cell lung cancer ( NS-NSCLC ) benefited from pemetrexed maintenance therapy after induction therapy with pemetrexed and cisplatin by extending survival , delaying disease progression , and maintaining quality of life ( QoL ) .
-BACKGROUND	However , low-grade 1 or 2 toxicities during long-term maintenance treatment may become burdensome and impact QoL .
-METHODS	Patients in this double-blind study ( n = 539 ) , who had completed 4 induction cycles ( pemetrexed with cisplatin ) without progressive disease ( PD ) and had an ECOG performance status of 0/1 , were randomized 2:1 to pemetrexed maintenance ( 500 mg/m ( 2 ) , day 1 ) plus best supportive care ( BSC ) or placebo plus BSC until PD .
-METHODS	Adverse events ( by maximum Common Terminology Criteria for Adverse Events [ CTCAE ] grade ) and QoL ( EuroQol 5-dimensional [ EQ-5D ] scale ) were assessed .
-RESULTS	A median of 4 maintenance cycles was administered ( range , pemetrexed 1-44 ; mean SD 7.9 8.3 ; placebo 1-38 ; mean SD 5.0 5.2 ) , with 28 % of pemetrexed and 12 % of placebo patients receiving 10 maintenance cycles .
-RESULTS	The pemetrexed dose intensity was 94 % .
-RESULTS	More patients receiving pemetrexed ( 12 % ) than placebo discontinued because of possible drug-related CTCAEs ( 4 % ; P = .005 ) .
-RESULTS	Overall , pemetrexed was associated with significantly more ( P < .05 ) low-grade events ( grade 1/2 nausea , grade 2 anemia , edema , and neutropenia ) than placebo .
-RESULTS	Overall , the incidence of low-grade fatigue , anemia , and neutropenia decreased with long-term pemetrexed exposure ; however , renal events increased across treatment arms .
-RESULTS	EQ-5D analyses demonstrated no treatment-by-time interaction or overall treatment differences between the 2 arms .
-CONCLUSIONS	PARAMOUNT demonstrated a low incidence of low-grade toxicities with long-term pemetrexed exposure without compromising QoL in patients with NS-NSCLC .
-
-###25322606
-OBJECTIVE	To explore the application of the Dexmedetomidine utend drug induced sleep endoscopy .
-METHODS	Forty-four OSAHS patients diagnosed by PSG randomly were divided into group A ( Dexmedetomidine group ) and group B ( Propofol group ) , each group of 22 cases .
-METHODS	Group A : pump the Dexmedetomidine ( 1 microg/kg ) over 15 minutes .
-METHODS	Once the patient reached a satisfactory level of sedation , the electronic nasopharyngoscope was introduced into the nasal cavity group B : the propofol ( 2 mg/kg ) was intravenous injected , use the same exmination after the object patients falling asleep .
-METHODS	If not , double the injection dose of the two group .
-METHODS	Observe and record the patient vital signs , EEG and sleep time , and handle the complications .
-RESULTS	The study was successfully completed both in group A and B. Mean arterial pressure ( MAP ) in group B was lower than group A during the examination significantly ( P < 0.05 ) .
-RESULTS	The time falling to sleep in two groups were ( 13.4 + / - 2.5 ) min and ( 6.6 + / - 1.2 ) min , and the time in group A was much longer than that in group B.
-RESULTS	The lowest oxygen saturation during the examination in two groups were 0.835 + / - 0.096 and 0.691 + / - 0.095 , and the difference was statistically significant .
-RESULTS	There was no incidence of adverse reactions in two groups .
-CONCLUSIONS	Compared with propofol , Dexmedetomidine is a safer sleep-inducing drug , and it can be used for clinical sleep endoscopy .
-
-###25514585
-BACKGROUND	Patient engagement in health care is increasingly recognized as essential for promoting the health of individuals and populations .
-BACKGROUND	This study pilot tested the standardized clinician ( SC ) methodology , a novel adaptation of standardized patient methodology , for teaching patient engagement skills for the complex health care situation of transitioning from a hospital back to home .
-METHODS	Sixty-seven participants at heightened risk for hospitalization were randomly assigned to either simulation exposure-only or full-intervention group .
-METHODS	Both groups participated in simulation scenarios with `` standardized clinicians '' around tasks related to hospital discharge and follow-up .
-METHODS	The full-intervention group was also debriefed after scenario sets and learned about tools for actively participating in hospital-to-home transitions .
-METHODS	Measures included changes in observed behaviors at baseline and follow-up and an overall program evaluation .
-RESULTS	The full-intervention group showed increases in observed tool possession ( P = 0.014 ) and expression of their preferences and values ( P = 0.043 ) .
-RESULTS	The simulation exposure-only group showed improvement in worksheet scores ( P = 0.002 ) and fewer engagement skills ( P = 0.021 ) .
-RESULTS	Both groups showed a decrease in telling an SC about their hospital admission ( P < 0.05 ) .
-RESULTS	Open-ended comments from the program evaluation were largely positive .
-CONCLUSIONS	Both groups benefited from exposure to the SC intervention .
-CONCLUSIONS	Program evaluation data suggest that simulation training is feasible and may provide a useful methodology for teaching patient skills for active engagement in health care .
-CONCLUSIONS	Future studies are warranted to determine if this methodology can be used to assess overall patient engagement and whether new patient learning transfers to health care encounters .
-
-###25256660
-OBJECTIVE	We investigated the relative pharmacokinetics , pharmacodynamics , and safety of the proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) inhibitor alirocumab following injection at three different sites .
-METHODS	Sixty healthy subjects ( 39 male , 21 female ; age 20-45 years ) were randomized to receive a single subcutaneous injection of alirocumab 75 mg via 1-mL prefilled pen into the abdomen , upper arm , or thigh ( NCT01785329 ) .
-METHODS	Subjects were followed for 85 days 2 days following study drug administration .
-METHODS	Pharmacokinetic ( PK ) parameters for the systemic exposure of alirocumab were calculated , and levels of free PCSK9 were assessed .
-METHODS	Percentage changes from baseline in LDL-C were compared between injection site groups using linear mixed-effects models .
-RESULTS	Alirocumab concentration-time profiles were similar , and free PCSK9 levels were reduced to approximately zero between Day 3 and Day 4 postinjection in all groups .
-RESULTS	LDL-C levels reached nadir on Day 15 postinjection in all groups with mean percentage reductions of 48.4 % ( abdomen ) , 39.5 % ( upper arm ) , and 45.6 % ( thigh ) at this time point .
-RESULTS	A similar effect on LDL-C levels was seen across the entire time course of the study at all three injection sites .
-RESULTS	Treatment-emergent adverse events were experienced by 8/20 ( abdomen ) , 11/20 ( upper arm ) , and 13/20 ( thigh ) subjects .
-RESULTS	There were 2 mild/transient injection site reactions .
-RESULTS	There were no serious adverse events .
-CONCLUSIONS	A single subcutaneous administration of alirocumab 75 mg via prefilled pen was well tolerated with similar pharmacokinetics and pharmacodynamics when injected into the abdomen , upper arm , or thigh .
-CONCLUSIONS	These results suggest that alirocumab can be interchangeably injected in the abdomen , upper arm , or thigh .
-
-###24374004
-OBJECTIVE	Diets where carbohydrate has been partially exchanged for protein have shown beneficial changes in persons with type 2 diabetes but no studies have enrolled people with albuminuria .
-OBJECTIVE	We aim to determine if a high protein to carbohydrate ratio ( HPD ) in an energy reduced diet has a beneficial effect on metabolic control and cardiovascular risk factors without negatively affecting renal function .
-RESULTS	Adult , overweight participants with type 2 diabetes , with albuminuria ( 30-600 mg/24 h or an albumin-to-creatinine ratio of 3.0-60 mg/mmol ) , and estimated GFR of > 40 ml/min/1 .73 m ( 2 ) were enrolled .
-RESULTS	Participants were randomized to an HPD or an SPD .
-RESULTS	Protein : fat : carbohydrate ratio was 30:30:40 % of energy for the HPD and 20:30:50 % for the SPD .
-RESULTS	Main outcomes were renal function , weight loss , blood pressure , serum lipids and glycaemic control .
-RESULTS	We recruited 76 volunteers and 45 ( 35 men and 10 women ) finished .
-RESULTS	There were no overall changes in renal function at 12 months and no significant differences in weight loss between groups ( 9.7 2.9 kg and 6.6 1.4 kg HPD and SPD group respectively ; p = 0.32 ) .
-RESULTS	Fasting blood glucose decreased significantly with no treatment effect .
-RESULTS	The decrease in HbA1c differed between treatments at 6 months ( HPD -0.9 vs. SPD -0.3 % ; p = 0.039 ) but not at 12 months .
-RESULTS	HDL increased significantly with no treatment effects .
-RESULTS	There were no changes in LDL or blood pressure overall but DBP was lower in the HPD group ( p = 0.024 ) at 12 months .
-CONCLUSIONS	Weight loss improved overall metabolic control in this group of well controlled participants with type 2 diabetes regardless of diet composition .
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-###24488447
-BACKGROUND	Orally administered chemical thromboprophylactic agents for total hip replacement ( THR ) have become popular in recent years .
-BACKGROUND	Certain clinical trials suggest that the efficacy and the risk of major bleeding after administration of direct thrombin inhibitor dabigatran etexilate are equivalent to the clinical trial comparator , subcutaneous low-molecular-weight heparin enoxaparin .
-BACKGROUND	Our aim was to compare and evaluate the incidence of minor haemorrhagic and soft-tissue adverse effects of enoxaparin and dabigatran .
-METHODS	122 patients who were treated by elective cemented primary THR were enrolled in our quasi-randomised study .
-METHODS	Two groups were formed according to which perioperative thromboprophylactic agent was used : 61 patients in enoxaparin group versus 61 patients in dabigatran group .
-METHODS	Thigh volume changes , calculated perioperative blood loss , area of haematoma , wound bleeding , duration of wound discharge and intensity of serous wound discharge on postoperative day 3 and day 7 were recorded .
-RESULTS	The duration and intensity of serous wound discharge differed significantly between the two groups .
-RESULTS	Duration of wound discharge after drain removal was 2.2 ( 2.7 ) days in the dabigatran group and 1.2 ( 1.9 ) days in the enoxaparin group ( p < 0.05 ) .
-RESULTS	Significant increase in serous discharge was found in the dabigatran group ( p < 0.05 ) on third and seventh postoperative days compared to the enoxaparin group .
-CONCLUSIONS	Both thromboprophylactic agents were found to have appropriate antithrombotic effects after THR .
-CONCLUSIONS	However , dabigatran was associated with an increased incidence of prolonged serous wound discharge , which might cause longer hospitalization and might instigate the use of prolonged antibiotic prophylaxis .
-
-###24962875
-OBJECTIVE	Infant colic is a frequent problem affecting up to 10-30 % of infants in first 3 months of life .
-OBJECTIVE	Results from previous trials have shown that manipulation of gut microbiota can lead to symptomatic improvements .
-OBJECTIVE	In a randomised clinical trial , we aimed to determine efficacy of synbiotic in reducing average infant crying time at day 7 and day 30 after starting intervention .
-METHODS	Fifty breastfed infants aged 15-120 days with infantile colic randomly assigned to receive either the synbiotic sachet containing 1 billion CFU of : Lactobacillus casei , L.rhamnosus , Streptococcus thermophilus , Bifidobacterium breve , L.acidophilus , B.infantis , L.bulgaricus and fructooligosacharide ( Protexin Healthcare , Somerset , UK ) , or placebo daily for 30 days .
-METHODS	Parents were asked to record details of crying times in a symptoms diary .
-METHODS	The primary outcome measure was the treatment success ( reduction in the daily crying time > 50 % ) and the secondary outcome measure was symptom resolution ( reduction in the daily crying time > 90 % ) .
-RESULTS	The treatment success was significantly higher in synbiotic group ( 82.6 % ) compared with placebo ( 35.7 % ) at day 7 ( P < 0.005 ) .
-RESULTS	At day30 , treatment success was 87 % and 46 % in synbiotic and placebo group , respectively ( P < 0.01 ) .
-RESULTS	Symptom resolution was also higher in synbiotic group ( 39 % ) compared with placebo ( 7 % ) at day 7 ( P < 0.03 ) but not at day 30 ( 56 % vs. 36 % , P = 0.24 ) .
-RESULTS	We encountered no complication related to synbiotic use .
-CONCLUSIONS	This synbiotic ( a mixture of seven probiotic strains plus FOS ) significantly improved colic symptoms in comparison with placebo .
-
-###26027245
-OBJECTIVE	To study the clinical and laboratory efficiency and safety of different etoricoxib ( ET ) regimens in patients with axial spondyloarthritis ( axSpA ) , including ankylosing spondylitis .
-METHODS	Forty patients with high axSpA activity ( Bath Ankylosing Disease Activity Index ( BASDAI 4 ) were examined and randomized to 2 groups : 1 ) 30 patients who received ET 90 mg continuously every day ; 2 ) 10 patients who took the drug in the same dose intermittently 1-3 times weekly .
-METHODS	The activity of axSpA ( BASDAI , Ankylosing Spondylitis Disease Activity Score ( ASDAS ) , erythrocyte sedimentation rate ( ESR ) , and high-sensitivity C-reactive protein ( hs-CRP ) ) was evaluated at baseline , 2 and 12 weeks ; adverse events were recorded at baseline , 2 , 6 , and 12 weeks .
-METHODS	The number of patients who had achieved an ASAS40 response at 2 and 12 weeks were taken into consideration .
-METHODS	RESULTS At 12 weeks , the continuous administration group displayed decreases in BASDAI from 8 to 4 , in ASDAS from 3.8 to 2.6 , and in hs-CRP levels from 9.5 to 3.9 mg/l ; the intermittent administration group exhibited decreases in BASDAI from 7.6 to 6.0 , in ASDAS from 3.5 to 3.1 , and hs-CRP from 8.8 to 4.5 mg/l ( p < 0.05 ) .
-METHODS	At this time , an AS40 response was achieved by 22 ( 73.3 % ) and 2 ( 20 % ) patients in Groups 1 and 2 , respectively ( p < 0.05 for all ) .
-METHODS	No serious adverse events were recorded .
-CONCLUSIONS	The efficacy of ET given in a daily dose of 90 mg was much higher than that of the drug used thrice or less weekly in the patients with axSpA .
-
-###25831644
-OBJECTIVE	To compare the outcome of Rhomboid excision and Modified Limberg 's flap closure with excision and primary closure for the treatment of Sacrococcygeal Pilonidal sinus .
-METHODS	The study was conducted at the Surgical Department of Mayo Hospital , Lahore , from 2009 to 2012 .
-METHODS	A total of 60 patients of pilonidal sinus were randomly divided into two equal groups .
-METHODS	The patients were operated under general anaesthesia in prone position by Rhomboid excision and Modified Limberg 's flap closure with a closed suction drain in group 1 , and excision and primary closure over a drain in group 2 .
-METHODS	Patients were followed up for 12 months for surgical complications of the treatment .
-METHODS	SPSS 17 was used for statistical analysis .
-RESULTS	In group 1 there were 27 ( 90 % ) males and 3 ( 10 % ) females , while group 2 had 28 ( 93.3 % ) males and 2 ( 6.7 % ) females .
-RESULTS	The infection rates were observed to be 2 ( 7 % ) in group 1 and 8 ( 26.6 % ) ( p < 0.038 ) in group 2 .
-RESULTS	The recurrence rate was only 1 ( 3.3 % ) in group 1 compared to 4 ( 13.3 % ) in group 2 .
-RESULTS	Average hospital stay was 1.630.67 days group 1 and 2.81.24 days in group 2 .
-CONCLUSIONS	Modified Limberg 's flap closure is an effective treatment modality for pilonidal sinus disease with 1.5 times less infection rate , 4 times less recurrence rate and 40 % in-hospital time .
-
-###24249817
-OBJECTIVE	Late-onset sepsis frequently complicates prematurity , contributing to morbidity and mortality .
-OBJECTIVE	Probiotics may reduce mortality and necrotizing enterocolitis ( NEC ) in preterm infants , with unclear effect on late-onset sepsis .
-OBJECTIVE	This study aimed to determine the effect of administering a specific combination of probiotics to very preterm infants on culture-proven late-onset sepsis .
-METHODS	A prospective multicenter , double-blinded , placebo-controlled , randomized trial compared daily administration of a probiotic combination ( Bifidobacterium infantis , Streptococcus thermophilus , and Bifidobacterium lactis , containing 1 10 ( 9 ) total organisms ) with placebo ( maltodextrin ) in infants born before 32 completed weeks ' gestation weighing < 1500 g.
-METHODS	The primary outcome was at least 1 episode of definite late-onset sepsis .
-RESULTS	Between October 2007 and November 2011 , 1099 very preterm infants from Australia and New Zealand were randomized .
-RESULTS	Rates of definite late-onset sepsis ( 16.2 % ) , NEC of Bell stage 2 or more ( 4.4 % ) , and mortality ( 5.1 % ) were low in controls , with high breast milk feeding rates ( 96.9 % ) .
-RESULTS	No significant difference in definite late-onset sepsis or all-cause mortality was found , but this probiotic combination reduced NEC of Bell stage 2 or more ( 2.0 % versus 4.4 % ; relative risk 0.46 , 95 % confidence interval 0.23 to 0.93 , P = .03 ; number needed to treat 43 , 95 % confidence interval 23 to 333 ) .
-CONCLUSIONS	The probiotics B infantis , S thermophilus , and B lactis significantly reduced NEC of Bell stage 2 or more in very preterm infants , but not definite late-onset sepsis or mortality .
-CONCLUSIONS	Treatment with this combination of probiotics appears to be safe .
-
-###25201508
-BACKGROUND	Most parental smokers are deeply invested in their child 's health , but it is unknown what factors influence parent risk perceptions of the effects of smoking on their child 's health and benefits to the child of cessation .
-OBJECTIVE	To explore differences in former versus current smokers ' beliefs about harm of continuing to smoke , benefits of quitting , and how much smoking interferes with their parenting .
-METHODS	As part of a cluster RCT to increase tobacco control in the pediatric setting , we analyzed data collected at the ten control arm practices for 24 months starting in May 2010 ; a cross-sectional secondary data analysis was conducted in 2013 .
-METHODS	Parents were asked about smoking status and perceived harm , benefit , and well-being related to smoking behaviors .
-RESULTS	Of the 981 enrolled smoking parents , 710 ( 72.4 % ) were contacted at 12 months .
-RESULTS	The odds of having successfully quit at 12 months was 4.12 times more likely ( 95 % CI = 1.57 , 10.8 ) for parents who believed that quitting will benefit their children ; 1.68 times more likely ( 95 % CI = 1.13 , 2.51 ) for parents with more than a high school education ; and 1.74 times greater ( 95 % CI = 1.13 , 2.68 ) for parents with children under age 3 years .
-RESULTS	Another factor associated with having successfully quit was a prior quit attempt .
-CONCLUSIONS	Providers ' smoking-cessation advice and support should begin early and underscore how cessation will benefit the health and well-being of patients ' children .
-CONCLUSIONS	Additionally , parents who have recently attempted to quit may be particularly primed for another attempt .
-
-###24268548
-BACKGROUND	The effectiveness of methadone as an opioid maintenance treatment ( OMT ) for opioid dependence has been widely demonstrated .
-BACKGROUND	However many patients continue to use other opioids while on methadone treatment .
-BACKGROUND	Studies assessing avoidable cases of continued non-prescribed opioid use during methadone treatment are sparse .
-METHODS	At 12 months of treatment ( M12 ) , 158 subjects had available data on opioid use , measured using the Opiate Treatment Index .
-METHODS	We identified variables associated with non-prescribed opioid use at M12 , using a univariate logistic regression and two multivariate models , one incorporating only pre-treatment variables , the second adding the in-treatment variables .
-METHODS	We also calculated attributable fractions for risk factors .
-RESULTS	At M12 , 32.3 % of the patients had used non-prescribed opioids during the previous month .
-RESULTS	A good patient-physician relationship was the most influential factor associated with not using non-prescribed opioids after one year .
-RESULTS	Living with a heroin user after one year of treatment , using cocaine during treatment and hazardous alcohol consumption at enrolment were all associated with an increased risk of non-prescribed opioid use at M12 .
-RESULTS	Analysis of attributable fractions indicated that living with a heroin user at M12 accounted for 21 % of patients reporting non-prescribed opioid use at M12 , while the lack of a good relationship with the physician accounted for 26 % .
-CONCLUSIONS	The attributable risk approach suggests that continued non-prescribed opioid use by a considerable proportion of individuals could potentially be reduced by improving patient-physician relationships , enhancing care for co-dependent patients and encouraging patients to modify their social network .
-
-###24220913
-BACKGROUND	Serum C-reactive protein ( CRP ) is a marker of acute inflammatory response and has been associated with health outcomes in some studies .
-BACKGROUND	Inflammation and immune response may have potential prognostic implications for breast cancer survivors .
-METHODS	The Women 's Healthy Eating and Living Study includes 2,919 early-stage breast cancer survivors with serum collected 2 years postdiagnosis and follow-up for clinical outcomes over approximately 7 years .
-METHODS	CRP concentrations were measured using high-sensitivity electrochemiluminescence assay .
-METHODS	Outcomes , including all-cause mortality , breast cancer-specific mortality , and additional breast cancer events were oncologist verified from medical records and death certificates .
-METHODS	Cox proportional hazards models were conducted with adjustment for potential confounding factors to generate HRs and 95 % confidence intervals ( CI ) .
-RESULTS	CRP concentrations in women diagnosed with breast cancer were associated with death due to any cause , death due to breast cancer , and additional breast cancer events , after adjustment for sociodemographic and cancer characteristics ( lnCRP : P < 0.05 for all three outcomes ) .
-RESULTS	The HR for women with ( vs. without ) acute inflammation suggests a threshold effect on overall survival , rather than a dose-response relationship ( 10.0 mg/L vs. < 1 mg/L : HR , 1.96 ; 95 % CI , 1.22-3 .13 ) .
-RESULTS	Associations were similar for breast cancer-specific mortality ( HR , 1.91 ; 95 % CI , 1.13-3 .23 ) and any additional breast cancer-related event ( HR , 1.69 ; 95 % CI , 1.17-2 .43 ) .
-CONCLUSIONS	Acute inflammation status ( CRP 10 mg/L ) may be an important independent biomarker for long-term survival in breast cancer survivors .
-CONCLUSIONS	Interventions to decrease circulating CRP concentrations in breast cancer survivors with acute inflammation may improve prognosis .
-
-###25234603
-BACKGROUND	We sought to investigate the use of tissue contact monitoring by means of the electrical coupling index ( ECI ) in a prospective randomised control trial of patients undergoing cavotricuspid isthmus ( CTI ) ablation for atrial flutter .
-METHODS	Patients with ECG-documented typical flutter undergoing their first CTI ablation were randomised to ECI-guided or non-ECI-guided ablation .
-METHODS	An irrigated-tip ablation catheter was used in all cases .
-METHODS	Consecutive 50-W , 60-s radiofrequency lesions were applied to the CTI , from the tricuspid valve to inferior vena cava , with no catheter movement permitted during radiofrequency ( RF ) delivery .
-METHODS	The ablation endpoint was durable CTI block at 20 min post-ablation .
-METHODS	Patients underwent routine clinic follow-up post-operatively .
-RESULTS	A total of 101 patients ( 79 male ) , mean age 66 ( + / -11 ) , 50 ECI-guided and 51 control cases were enrolled in the study .
-RESULTS	CTI block was achieved in all .
-RESULTS	There were no acute complications .
-RESULTS	All patients were alive at follow-up .
-RESULTS	CTI block was achieved in a single pass in 36 ECI-guided and 30 control cases ( p = 0.16 ) , and at 20 min post-ablation , re-conduction was seen in 5 and 12 cases , respectively ( p = 0.07 ) .
-RESULTS	There was no significant difference in total procedure time ( 62.733 vs. 62.333 min , p = 0.92 ) , RF requirement ( 580312 vs. 574287 s , p = 0.11 ) or fluoroscopy time ( 718577 vs. 721583 s , p = 0.78 ) .
-RESULTS	After 64 months , recurrence of flutter had occurred in 1 ( 2 % ) ECI vs. 8 ( 16 % ) control cases ( OR 0.13 , 95 % CI 0.01-1 .08 , p = 0.06 ) .
-CONCLUSIONS	ECI-guided CTI ablation demonstrated a non-statistically significant reduction in late recurrence of atrial flutter , at no cost to procedural time , radiation exposure or RF requirement .
-
-###24246210
-OBJECTIVE	Our objective was to compare the efficacy and safety of imidafenacin over fesoterodine in patients with overactive bladder ( OAB ) .
-METHODS	This study is a randomised , double-blind , parallel-group , fesoterodine-controlled study in patients with continuous OAB symptoms for 3months , daily mean voiding frequency ( DMVF ) 8 , and daily mean urgency or urgency incontinence frequency 2 .
-METHODS	A twice-daily 0.1 mg imidafenacin with placebo , or once-daily 4mg fesoterodine with placebo were administered for 12weeks .
-METHODS	The primary efficacy end-point was the difference in DMVF at 12weeks .
-METHODS	The secondary efficacy end-points were differences in daily mean : ( i ) voiding frequency at 4 and 8weeks ; ( ii ) urgency frequency ; ( iii ) urgency incontinence frequency ; ( iv ) incontinence frequency ; ( v ) nocturia frequency ; and ( vi ) quality of life score .
-METHODS	The variables for safety analysis were adverse events , vital signs , residual urine volume and clinical laboratory tests .
-METHODS	An efficacy analysis was conducted in per-protocol patients and the safety analysis was conducted in all randomised patients .
-RESULTS	The differences in DMVF at 12weeks were -3.383.63 and -2.453.73 in the imidafenacin and fesoterodine groups , respectively , and the difference was not significant between the two groups .
-RESULTS	Imidafenacin was non-inferior to fesoterodine , and the lower limit of 95 % two-sided confidence intervals was -0.53 .
-RESULTS	The other six secondary end-points and variables for safety analysis showed no difference between the two groups .
-CONCLUSIONS	Imidafenacin was non-inferior to fesoterodine in terms of efficacy , and showed no significant difference in terms of safety .
-
-###24884415
-BACKGROUND	Progress during early labour may impact subsequent labour trajectories .
-BACKGROUND	Women admitted to hospital in latent phase ( < 3cm cervical dilation ) labour have been shown to be at higher risk of obstetrical interventions .
-METHODS	We conducted a secondary analysis of data from a randomized controlled trial of 1247 healthy nulliparous women in spontaneous labour at term with a singleton fetus in cephalic presentation at seven hospitals in Southwestern British Columbia .
-METHODS	We computed relative risks and their 95 % confidence intervals to examine our primary outcome of cesarean section and secondary outcomes including obstetrical interventions and maternal and newborn outcomes according to women 's perception of length of pre-hospital labour .
-METHODS	Women were asked on admission to hospital how long they had been experiencing contractions prior to coming to hospital .
-RESULTS	Women indicating that they had been in labour for 24hours or longer at the time of hospital admission were at elevated risk for cesarean birth , relative risk ( RR ) 1.40 , ( 95 % Confidence Intervals 1.15-1 .72 ) , admission with a cervical dilation of 3cm or less , RR 1.21 ( 1.07-1 .36 ) , more obstetrical interventions including continuous electronic fetal monitoring RR 1.11 ( 1.03-1 .20 ) , augmentation of labour RR 1.33 ( 1.23-1 .44 ) , use of narcotic RR 1.21 ( 1.06-1 .37 ) and epidural analgesia RR 1.18 ( 1.09-1 .28 ) .
-RESULTS	Adverse neonatal outcomes did not differ apart from a significant increase in meconium-stained amniotic fluid RR 1.60 ( 1.09-2 .35 ) .
-CONCLUSIONS	A single question asked of women on presentation to hospital was an important predictor of cesarean birth and may have utility in identifying women who would benefit from close observation and more active management of labour .
-
-###26241433
-OBJECTIVE	To describe the effects of six interventions for menopausal vasomotor symptoms relative to control in a pooled analysis , facilitating translation of the results for clinicians and symptomatic women .
-OBJECTIVE	The Menopause Strategies : Finding Lasting Answers for Symptoms and Health network tested these interventions in three randomized clinical trials .
-METHODS	An analysis of pooled individual-level data from three randomized clinical trials is presented .
-METHODS	Participants were 899 perimenopausal and postmenopausal women with at least 14 bothersome vasomotor symptoms per week .
-METHODS	Interventions included 10-20 mg escitalopram per day , nonaerobic yoga , aerobic exercise , 1.8 g per day omega-3 fatty acid supplementation , 0.5 mg low-dose oral 17-beta-estradiol ( E2 ) per day , and 75 mg low-dose venlafaxine XR per day .
-METHODS	The main outcome measures were changes from baseline in mean daily vasomotor symptom frequency and bother during 8-12 weeks of treatment .
-METHODS	Linear regression models estimated differences in outcomes between each intervention and corresponding control group adjusted for baseline characteristics .
-METHODS	Models included trial-specific intercepts , effects of the baseline outcome measure , and time .
-RESULTS	The 8-week reduction in vasomotor symptom frequency from baseline relative to placebo was similar for escitalopram at -1.4 per day ( 95 % confidence interval [ CI ] -2.7 to -0.2 ) , low-dose E2 at -2.4 ( 95 % CI -3.4 to -1.3 ) , and venlafaxine at -1.8 ( 95 % CI -2.8 to -0.8 ) ; vasomotor symptom bother reduction was minimal and did not vary across these three pharmacologic interventions ( mean -0.2 to -0.3 relative to placebo ) .
-RESULTS	No effects on vasomotor symptom frequency or bother were seen with aerobic exercise , yoga , or omega-3 supplements .
-CONCLUSIONS	These analyses suggest that escitalopram , low-dose E2 , and venlafaxine provide comparable , modest reductions in vasomotor symptom frequency and bother among women with moderate hot flushes .
-BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT00894543 ( MsFLASH 01 ) , NCT01178892 ( MsFLASH 02 ) , and NCT01418209 ( MsFLASH 03 ) .
-
-###25211767
-OBJECTIVE	Most patients with tinnitus also have hearing loss .
-OBJECTIVE	Hearing aids have been well-documented to provide amelioration for both hearing and tinnitus problems .
-OBJECTIVE	Some hearing aids have built-in noise/sound generators that are intended to provide added benefit to patients with tinnitus .
-OBJECTIVE	It has not been proven , however , whether these `` combination instruments '' are more effective for tinnitus management than hearing aids alone .
-OBJECTIVE	The purpose of this study was to collect initial data addressing this question .
-METHODS	Thirty individuals meeting study requirements ( bothersome tinnitus , hearing aid candidate , and no use of hearing aids for the previous 12 months ) were enrolled .
-METHODS	All participants initially completed the primary outcome questionnaire ( Tinnitus Functional Index [ TFI ] ) and then returned to be fitted with combination instruments .
-METHODS	The hearing aid portion of the devices was adjusted to optimize hearing ability .
-METHODS	Participants were then randomized to either the experimental group ( n = 15 ) or the control group ( n = 15 ) .
-METHODS	The experimental group had the noise feature of the instruments activated and adjusted to achieve optimal relief from tinnitus .
-METHODS	The control group did not have the noise portion activated .
-METHODS	Following the hearing aid fitting , all study participants also received brief tinnitus counseling .
-METHODS	Participants returned 1 to 2 weeks later for a follow-up appointment to confirm proper fit of the instruments and to make any necessary programming adjustments .
-METHODS	Additionally , they returned 3 months after the fitting to complete the TFI , which also concluded their participation in the study .
-RESULTS	Both groups revealed significant improvement , as indicated by reductions in mean TFI index scores .
-RESULTS	Differences between groups at 3 months were not statistically significant .
-RESULTS	However , the experimental group showed a mean reduction in the TFI score that was 6.4 points greater than that for the control group .
-RESULTS	The difference approached significance ( p = 0.09 ) , suggesting that a larger group of participants may have resulted in a significant difference between groups .
-RESULTS	This possibility is tempered by the fact that effect sizes , which control for variation , were very similar between groups .
-CONCLUSIONS	Results of this study suggest that the use of hearing aids alone or hearing aids plus the use of sound generators both provide significant benefit with respect to alleviating effects of tinnitus .
-CONCLUSIONS	A larger controlled clinical trial is needed to obtain more definitive results regarding the two configurations of hearing aids .
-
-###24320206
-OBJECTIVE	To compare bidirectional knotless barbed suture versus standard sutures , with either extracorporeal or intracorporeal knots , and to assess the feasibility , safety , and rapidity in repairing a uterine wall defect after laparoscopic myomectomy .
-METHODS	This was a randomized clinical study having a Canadian Task Force Classification of I.
-METHODS	In tertiary-care university-based teaching hospitals , 117 women who underwent laparoscopic myomectomy were enrolled .
-METHODS	In accord with randomization , uterine wall defects were closed with either extracorporeal ( poliglecaprone 25 ; Monocryl-1 ; Ethicon Inc. , Somerville , NJ ) or intracorporeal ( polyglactin 910 ; Vicryl-1 ; Ethicon Inc. ) knots or a bidirectional knotless barbed suture ( Quill-0 ; Angiotech Pharmaceuticals , Inc. , Vancouver , BC , Canada ) .
-RESULTS	Time required to suture was significantly lower in the group operated on with a bidirectional suture than in groups with traditional sutures ( P < .001 ) .
-RESULTS	No significant difference was observed in operative time among the study groups .
-RESULTS	The degree of surgical difficulty was significantly lower in the Quill group than in the other groups .
-CONCLUSIONS	Use of barbed sutures reduces the time required to repair a uterine wall defect during laparoscopic myomectomy .
-CONCLUSIONS	In a follow-up of patients carried out at 3 months , 6 months , and 1 year after the surgery , there were no wound dehiscence , no bleeding , and no other potential major complications .
-
-###24898857
-OBJECTIVE	To estimate the effectiveness of candidate microbicides BufferGel and 0.5 % PRO 2000 Gel ( P ) ( PRO 2000 ) for prevention of non-ulcerative sexually transmitted infections ( STIs ) .
-METHODS	Between 2005 and 2007 , 3099 women were enrolled in HIV Prevention Trials Network ( HPTN ) protocol 035 , a phase II/IIb evaluation of the safety and effectiveness of BufferGel and PRO 2000 for prevention of STIs , including Neisseria gonorrhoeae ( NG ) , Chlamydia trachomatis ( CT ) and Trichomonas vaginalis ( TV ) .
-METHODS	Incidences of STIs were determined by study arm , and HRs of BufferGel and PRO 2000 versus placebo gel or no gel control groups were computed using discrete time Andersen-Gill proportional hazards model .
-RESULTS	The overall incidence rates were 1.6 / 100 person-years at risk ( PYAR ) for NG , 3.9 / 100 PYAR for CT and 15.3 / 100 PYAR for TV .
-RESULTS	For BufferGel versus placebo gel , HRs were 0.99 ( 95 % CI 0.49 to 2.00 ) , 1.00 ( 95 % CI 0.64 to 1.57 ) and 0.95 ( 95 % CI 0.71 to 1.25 ) for prevention of NG , CT and TV , respectively .
-RESULTS	For PRO 2000 , HRs were 1.66 ( 95 % CI 0.90 to 3.06 ) , 1.16 ( 95 % CI 0.76 to 1.79 ) and 1.18 ( 95 % CI 0.90 to 1.53 ) for prevention of NG , CT and TV , respectively .
-CONCLUSIONS	The incidence of STIs was high during HIV Prevention Trials Network 035 despite provision of free condoms and comprehensive risk-reduction counselling , highlighting the need for effective STI prevention programmes in this population .
-CONCLUSIONS	Unfortunately , candidate microbicides BufferGel and PRO2000 had no protective effect against gonorrhoea , chlamydia or trichomoniasis .
-BACKGROUND	NCT00074425 .
-
-###24266670
-BACKGROUND	Basiliximab is a chimeric monoclonal antibody directed against the alpha chain of interleukin-2 receptor ( IL-2R ) .
-BACKGROUND	When administered intravenously at a dosage of 20 mg at the time of transplantation and 4 days later , basiliximab saturates the alpha chain of IL-2R for 4 weeks .
-METHODS	This review evaluates the efficacy and safety of basiliximab in kidney transplantation .
-METHODS	Randomized controlled trials showed that basiliximab can significantly reduce the incidence of acute rejection without increasing the risk of adverse events .
-METHODS	When compared with other antibodies used for induction , basiliximab showed efficacy and safety profiles similar to daclizumab , another monoclonal antibody directed against the alpha chain of IL-2R .
-METHODS	In comparison with rabbit anti-thymocyte globulins ( rATG ) , basiliximab showed a similar efficacy .
-METHODS	However , in patients at higher risk of rejection , rATG proved to be more effective .
-METHODS	No serious safety problems related to basiliximab have been reported .
-CONCLUSIONS	There is a solid evidence that basiliximab can significantly decrease the risk of acute rejection in kidney transplant recipients without increasing adverse events .
-CONCLUSIONS	This can allow decreased dosage or avoidance of glucocorticoids and reduced dosage of calcineurin inhibitors .
-CONCLUSIONS	On the basis of efficacy , tolerability , ease of administration , and cost effectiveness , basiliximab may be considered the drug of choice for the prophylaxis of acute rejection in standard renal transplant recipients .
-
-###24673650
-OBJECTIVE	Few studies have examined the long-term sustainability of complete seizure freedom on the ketogenic diet ( KD ) .
-OBJECTIVE	The purpose of this study was to describe the risk of seizure recurrence in children who achieved at least 1month of seizure freedom on the KD , and to assess clinical features associated with sustained seizure freedom .
-METHODS	Records of patients initiated on the KD at The Children 's Hospital of Philadelphia ( CHOP ) from 1991 to 2009 were reviewed .
-METHODS	Subjects who attained seizure freedom for at least 1month within 2years were included in the study .
-METHODS	Seizure frequency was recorded based on caregiver-reported seizure diaries as unchanged , improved , or worse compared to baseline .
-METHODS	Those patients with seizure freedom 1year were compared to those with seizure freedom < 1year in terms of demographics , age of seizure onset , number of antiepileptic drugs ( AEDs ) prior to KD , and epilepsy classification .
-RESULTS	Of 276 patients initiated on the KD , 65 patients ( 24 % ) attained seizure freedom for a minimum of 1month .
-RESULTS	The majority of these patients had daily seizures .
-RESULTS	The median time to seizure freedom after KD initiation was 1.5 months .
-RESULTS	Seizures recurred in 53 patients ( 82 % ) , with a median time to seizure recurrence of 3months .
-RESULTS	However , seizure frequency after initial recurrence remained far less than baseline .
-RESULTS	No clinical features were identified as risk factors for seizure recurrence .
-CONCLUSIONS	Seizure recurrence on the KD after 1month of seizure freedom most often occurred as occasional breakthrough seizures and not a return to baseline seizure frequency .
-CONCLUSIONS	This study provides evidence to support the continued use of the KD in patients with initial seizure freedom even after breakthrough seizures .
-CONCLUSIONS	A PowerPoint slide summarizing this article is available for download in the Supporting Information section here .
-
-###25325193
-BACKGROUND	The objectives of this research were to compare a Web-based curriculum with a traditional lecture format on medical students ' cultural competency attitudes using a standardized instrument and to examine the internal consistency of the standardized instrument .
-METHODS	In 2010 , we randomized all 180 1st-year medical students into a Web-based ( intervention group ) or a lecture-based ( control group ) cultural competency training .
-METHODS	The main outcome was the overall score on the Health Belief Attitudes Survey ( 1 = lowest , 6 = highest ) .
-METHODS	We examined internal consistency with factor analysis .
-RESULTS	No differences were observed in the overall median scores between the intervention ( median 5.2 ; 25th percentile [ Q1 ] 4.9 , 75th percentile [ Q3 ] 5.5 ) and the control groups ( median 5.3 , Q1 4.9 , Q3 5.6 ) ( P = 0.77 ) .
-RESULTS	The internal consistency of the 2 main subcomponents was good ( Cronbach 's alpha = 0.83 ) to acceptable ( Cronbach 's alpha = 0.69 ) .
-CONCLUSIONS	A Web-based and a lecture-based cultural competency training strategies were associated with equally high positive attitudes among 1st-year medical students .
-CONCLUSIONS	These findings warrant further evaluation of Web-based cultural competency educational interventions .
-
-###24488359
-BACKGROUND	During arthroscopy , the localization of calcific deposit in patients suffering from calcifying tendinitis can be demanding and time consuming , frequently using ionizing radiation .
-BACKGROUND	Intraoperative ultrasound has been recently promoted , facilitating deposit localization and reducing radiation dose .
-METHODS	In this prospective , randomized , controlled and clinical observer-blinded pilot trial , 20 patients with calcific tendinitis were operated .
-METHODS	In group I , the deposit was localized conventionally .
-METHODS	In group II , the deposit was localized using intraoperative ultrasound .
-METHODS	The needle punctures to detect the deposit and operation times were noted .
-METHODS	Patients were postoperatively evaluated after 2 and 6weeks and 9months .
-RESULTS	In group II , the needle punctures to detect the deposit were significantly lower than in group I ( p < 0.0001 ) .
-RESULTS	Operation time to localize the deposit was also significantly less in group II ( p < 0.033 ) .
-RESULTS	In both groups , patients improved significantly with increased shoulder function ( p < 0.0001 ) and decreased pain ( p < 0.0001 ) 2weeks and 9months ( p < 0.001 ) after surgery .
-RESULTS	The difference between the groups was not significant .
-RESULTS	Excellent radiological findings were obtained in both groups after 9months .
-CONCLUSIONS	Intraoperative US significantly facilitates the detection of calcific deposits during arthroscopic debridement by speeding up surgery and reducing the number of needle punctures .
-CONCLUSIONS	Hence , we have changed our method of detecting calcific deposits intraoperatively from fluoroscopy to ultrasound .
-
-###25140337
-BACKGROUND	Dislocation of epidural catheters ( EC ) is associated with early termination of regional analgesia and rare complications like epidural bleeding .
-BACKGROUND	We tested the hypothesis that maximum effort in fixation by tunneling and suture decreases the incidence of catheter dislocation .
-METHODS	Patients scheduled for major surgery ( n = 121 ) were prospectively randomized in 2 groups .
-METHODS	Thoracic EC were subcutaneously tunneled and sutured ( tunneled ) or fixed with adhesive tape ( taped ) .
-METHODS	The difference of EC length at skin surface level immediately after insertion and before removal was determined and the absolute values were averaged .
-METHODS	Postoperative pain was evaluated by numeric rating scale twice daily and EC tips were screened microbiologically after removal .
-RESULTS	Both groups did not differ with respect to treatment duration ( tunneled : 109 hours 46 , taped : 97 37 ) and postoperative pain scores .
-RESULTS	Tunneling significantly reduced average extent ( tunneled : 3 mm 7 , taped : 10 18 ) and incidence of clinically relevant EC dislocation ( > 20 mm , tunneled : 1/60 , taped : 9/61 ) .
-RESULTS	Bacterial contamination showed a tendency to be lower in patients with tunneled catheters ( 8/59 , taped : 14/54 , P = 0.08 ) .
-CONCLUSIONS	Thorough fixation of EC by tunneling and suturing decreases the incidence and extent of dislocation and potentially even that of bacterial contamination .
-
-###24972789
-BACKGROUND	Since general anaesthesia invariably accompanies surgery , the contribution of each to the development of postoperative cognitive dysfunction ( POCD ) has been difficult to identify .
-METHODS	A prospective randomized controlled trial was undertaken in elderly patients undergoing extracorporeal shock wave lithotripsy ( ESWL ) .
-METHODS	Between 2005 and 2011 , 2706 individuals were screened to recruit 100 eligible patients .
-METHODS	Patients were randomly assigned to receive general or spinal anaesthesia alone .
-METHODS	A battery of eight neuropsychological tests was administered before operation and at 7 days and 3 months after operation .
-METHODS	The reliable change index was used to calculate the incidence of POCD .
-METHODS	Intention-to-treat analysis was used to compare rates of POCD .
-RESULTS	Futility analysis led to stopping of the trial after recruitment of 100 patients .
-RESULTS	Fifty patients were randomly assigned to general anaesthesia , and 48 patients to spinal anaesthesia without sedation or postoperative opioids .
-RESULTS	At 3 months , POCD was detected in 6.8 % [ 95 % confidence interval ( CI ) : 1.4-18 .7 % ] of patients in the general anaesthesia group and 19.6 % ( 95 % CI : 9.4-33 .9 % ) in the spinal group ( P = 0.07 ) .
-RESULTS	At 7 days after operation , the incidence of POCD was 4.1 % ( 95 % CI : 0.5-14 % ) in the general anaesthesia group and 11.9 % ( 95 % CI : 4.0-26 .6 % ) in the spinal group ( P = 0.16 ) .
-CONCLUSIONS	We found no significant difference in the rates of POCD when comparing general anaesthesia with spinal anaesthesia , suggesting that the surgical or procedural process itself may contribute to the development of POCD .
-BACKGROUND	Australian Clinical Trials Registry number ACTRN12605000150640 .
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-###25086821
-OBJECTIVE	The objective of this study was to compare combined internal and external fixation ( CIEF ) with minimally invasive percutaneous plate osteosynthesis ( MIPPO ) in the treatment of distal third tibial fractures , and explore the benefits and defects of these two techniques .
-METHODS	From April 2004 to February 2012 , a total of 44 patients were randomised to operative stabilisation either by two closed titanium elastic nails combined with an external fixator ( CIEF , 22 ) or by minimally invasive percutaneous osteosynthesis with a locking plate ( MIPPO , 22 ) .
-METHODS	Pre-operative variables included the patients ' age , sex , fracture side , cause of injury , Tscherne classification of soft tissue injury , fracture pattern , presence of open fracture and interval from injury to surgery .
-METHODS	Peri-operative variables were the operating time and the radiation time .
-METHODS	Postoperative variables were wound problems , bone union time , time of recovery to work , the functional American Orthopaedic Foot and Ankle surgery ( AOFAS ) score and removal of hardware .
-RESULTS	There was no significant difference in the time to union , the time of recovery to work , function , alignment and total AOFAS scores between the two groups ( P = 0.704 , 0.835 , 0.551 , 0.716 and 0.212 , respectively ) .
-RESULTS	The mean operating time and radiation time were longer in the MIPPO group than in the CIEF group ( 85.312.5 vs. 73.212.0 minutes , P = 0.002 , and 3.11.5 vs. 2.11.2 minutes , P = 0.019 , respectively ) .
-RESULTS	Wound complications were more common in the MIPPO group ( 18.2 % vs. 0 % with CIEF , P = 0.105 ) .
-RESULTS	There was a trend for patients with MIPPO to have a higher incidence of ankle pain ( 31.8 % vs. 9.1 % with CIEF , P = 0.135 ) .
-RESULTS	Painful implants were removed in 31.8 % of patients with MIPPO versus 9.1 % with CIEF ( P = 0.135 ) .
-RESULTS	Of the 165 self-tapping locking screws of the locking plates seven ( four patients ) were removed with some difficulty because of stripping of the hexagonal recess .
-CONCLUSIONS	Our results indicated that both CIEF and MIPPO were all efficient methods for treating distal third tibial fractures .
-CONCLUSIONS	However , CIEF had the advantages of a shorter operating and radiation time , less wound complication and ankle pain , less secondary operations for implant removal and easier removal of the implants .
-
-###26009229
-BACKGROUND	For patients with type 2 diabetes who do not achieve target glycaemic control with conventional insulin treatment , advancing to a basal-bolus insulin regimen is often recommended .
-BACKGROUND	We aimed to compare the efficacy and safety of long-acting glucagon-like peptide-1 receptor agonist dulaglutide with that of insulin glargine , both combined with prandial insulin lispro , in patients with type 2 diabetes .
-METHODS	We did this 52 week , randomised , open-label , phase 3 , non-inferiority trial at 105 study sites in 15 countries .
-METHODS	Patients ( aged 18 years ) with type 2 diabetes inadequately controlled with conventional insulin treatment were randomly assigned ( 1:1:1 ) , via a computer-generated randomisation sequence with an interactive voice-response system , to receive once-weekly dulaglutide 15 mg , dulaglutide 075 mg , or daily bedtime glargine .
-METHODS	Randomisation was stratified by country and metformin use .
-METHODS	Participants and study investigators were not masked to treatment allocation , but were unaware of dulaglutide dose assignment .
-METHODS	The primary outcome was a change in glycated haemoglobin A1c ( HbA1c ) from baseline to week 26 , with a 04 % non-inferiority margin .
-METHODS	Analysis was by intention to treat .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT01191268 .
-RESULTS	Between Dec 9 , 2010 , and Sept 21 , 2012 , we randomly assigned 884 patients to receive dulaglutide 15 mg ( n = 295 ) , dulaglutide 075 mg ( n = 293 ) , or glargine ( n = 296 ) .
-RESULTS	At 26 weeks , the adjusted mean change in HbA1c was greater in patients receiving dulaglutide 15 mg ( -164 % [ 95 % CI -178 to -150 ] , -1793 mmol/mol [ -1944 to -1642 ] ) and dulaglutide 075 mg ( -159 % [ -173 to -145 ] , -1738 mmol/mol [ -1889 to -1587 ] ) than in those receiving glargine ( -141 % [ -155 to -127 ] , -1541 mmol/mol [ -1692 to -1390 ] ) .
-RESULTS	The adjusted mean difference versus glargine was -022 % ( 95 % CI -038 to -007 , -240 mmol/mol [ -415 to -077 ] ; p = 0005 ) for dulaglutide 15 mg and -017 % ( -033 to -002 , -186 mmol/mol [ -361 to -022 ] ; p = 0015 ) for dulaglutide 075 mg .
-RESULTS	Five ( < 1 % ) patients died after randomisation because of septicaemia ( n = 1 in the dulaglutide 15 mg group ) ; pneumonia ( n = 1 in the dulaglutide 075 mg group ) ; cardiogenic shock ; ventricular fibrillation ; and an unknown cause ( n = 3 in the glargine group ) .
-RESULTS	We recorded serious adverse events in 27 ( 9 % ) patients in the dulaglutide 15 mg group , 44 ( 15 % ) patients in the dulaglutide 075 mg group , and 54 ( 18 % ) patients in the glargine group .
-RESULTS	The most frequent adverse events , arising more often with dulaglutide than glargine , were nausea , diarrhoea , and vomiting .
-CONCLUSIONS	Dulaglutide in combination with lispro resulted in a significantly greater improvement in glycaemic control than did glargine and represents a new treatment option for patients unable to achieve glycaemic targets with conventional insulin treatment .
-BACKGROUND	Eli Lilly and Company .
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-###25501607
-BACKGROUND	The evidence base for effects of nutritional interventions for malnourished HIV-infected patients starting antiretroviral therapy ( ART ) is limited and inconclusive .
-OBJECTIVE	We hypothesized that both vitamin and mineral deficiencies and poor appetite limit weight gain in malnourished patients starting ART and that vitamin and mineral supplementation would improve appetite and permit nutritional recovery .
-METHODS	The randomized controlled Nutritional Support for Africans Starting Antiretroviral Therapy trial was conducted in Mwanza , Tanzania , and Lusaka , Zambia .
-METHODS	ART-naive adults referred for ART and with body mass index < 18.5 kg/m received lipid-based nutritional supplements either without ( LNS ) or with added vitamins and minerals ( LNS-VM ) , beginning before ART initiation .
-METHODS	Participants were given 30 g/d LNS from recruitment until 2 weeks after starting ART and 250 g/d from weeks 2 to 6 of ART .
-RESULTS	Of 1815 patients recruited , 365 ( 20 % ) died during the study and 813 ( 45 % ) provided data at 12 weeks .
-RESULTS	Controlling for baseline values , anthropometric measures were consistently higher at 12-week ART in the LNS-VM than in the LNS group but statistically significant only for calf and mid-upper arm circumferences and triceps skinfold .
-RESULTS	Appetite did not differ between groups .
-RESULTS	Using piecewise mixed-effects quadratic models including all patients and time points , the main effects of LNS-VM were seen after starting ART and were significant for weight , body mass index , and mid-upper arm circumference .
-CONCLUSIONS	Provision of high levels of vitamins and minerals to patients referred for ART , delivered with substantial macronutrients , increased nutritional recovery but did not seem to act through treatment group differences in appetite .
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-###24384865
-BACKGROUND	Negative effects of dehydration on the human brain and cognitive function have been reported .
-BACKGROUND	In this study , we examined the effects of dehydration on pain thresholds and cortical activations in response to pain , compared with rehydration with an oral rehydration solution ( ORS ) by functional magnetic resonance imaging .
-METHODS	Five healthy adult men were subjected to dehydration and rehydration on 2 different days .
-METHODS	The condition on the first day was randomly assigned to each subject .
-METHODS	They completed a 40-minute exercise protocol using a walking machine after 12 hours of fasting under both conditions .
-METHODS	For rehydration , the subjects consumed up to 3000 mL ORS starting from the night before the test day .
-METHODS	After exercise , a painful stimulus ( cold pressor test ) was applied to the subjects ' medial forearm in a magnetic resonance imaging scanning gantry , and pain-evoked brain activation was analyzed .
-RESULTS	On the rehydration day , each of the subjects consumed an average of 2040 mL ( range ; 1800-2500 mL ) ORS .
-RESULTS	Physiological data revealed that subjects when dehydrated lost more weight from exercise than subjects when rehydrated had a larger heart rate increase , a higher tympanic temperature , and a higher urine osmolality .
-RESULTS	Subjective data revealed that the subjects reported significantly stronger thirst while dehydrated than while rehydrated with ORS , although the levels of hunger and anxiety and mood did not significantly differ between conditions .
-RESULTS	The cold pressor test robustly activated the pain-related neural network , notably the anterior cingulate cortex , insula , and thalamus .
-RESULTS	Such activations in the dehydrated subjects were greater than those in the rehydrated subjects in terms of peak and cluster , accompanied by a decrease in pain threshold ( P = 0.001 ) .
-CONCLUSIONS	Our findings suggest that dehydration brings about increased brain activity related to painful stimuli together with enhanced thirst , whereas rehydration with ORS alleviates thirst and decreases brain activity related to painful stimuli .
-
-###24500060
-BACKGROUND	During emergence from anesthesia , breathing 100 % oxygen is frequently used to provide a safety margin toward hypoxemia in case an airway problem occurs .
-BACKGROUND	Oxygen breathing has been shown to cause pulmonary gas exchange disorders in healthy individuals .
-BACKGROUND	This study investigates how oxygen breathing during emergence affects lung function specifically whether oxygen breathing causes added hypoxemia in patients with chronic obstructive pulmonary disease .
-METHODS	This trial has been conducted in a parallel-arm , case-controlled , open-label manner .
-METHODS	Fifty-three patients with chronic obstructive pulmonary disease were randomly allocated ( computer-generated lists ) to breathe either 100 or 30 % oxygen balanced with nitrogen during emergence from anesthesia .
-METHODS	Arterial blood gas measurements were taken before induction and at 5 , 15 , and 60 min after extubation .
-RESULTS	All participants tolerated the study well .
-RESULTS	Patients treated with 100 % oxygen had a higher alveolar-arterial oxygen pressure gradient ( primary outcome ) compared with patients treated with 30 % oxygen ( 25 vs. 20 mmHg ) and compared with their baseline at the 60-min measurement ( 25 vs. 17 mmHg ) .
-RESULTS	At the 60-min measurement , arterial partial pressure of oxygen was lower in the 100 % group ( 62 vs. 67 mmHg ) .
-RESULTS	Arterial partial pressure of carbon dioxide and pH were not different between groups or measurements .
-CONCLUSIONS	In this experiment , the authors examined oxygen breathing during emergence-a widely practiced maneuver known to generate pulmonary blood flow heterogeneity .
-CONCLUSIONS	In the observed cohort of patients already presenting with pulmonary blood flow disturbances , emergence on oxygen resulted in deterioration of oxygen-related blood gas parameters .
-CONCLUSIONS	In the perioperative care of patients with chronic obstructive pulmonary disease , oxygen breathing during emergence from anesthesia may need reconsideration .
-
-###25263393
-OBJECTIVE	Rifampicin is a potent inducer of P-glycoprotein ( P-gp ) and inhibitor of organic anion-transporting polypeptides ( OATPs ) , with fexofenadine acting as a substrate for both mechanisms .
-OBJECTIVE	Simultaneous administration of single - or multiple-dose rifampicin 600 mg significantly increases the concentrations of fexofenadine enantiomers by inhibiting OATP transporters .
-OBJECTIVE	However , the effects of rifampicin 450 mg are unknown .
-OBJECTIVE	Here , we evaluated the effects of multiple doses of rifampicin 450 mg on the pharmacokinetics of fexofenadine enantiomers in healthy Japanese volunteers .
-METHODS	In this randomized , two-phase , double-blind crossover study , 10 healthy volunteers received rifampicin 450 mg/day or placebo for 7 days .
-METHODS	On day 7 , fexofenadine 60 mg was co-administered simultaneously .
-CONCLUSIONS	Rifampicin significantly increased the mean area under the plasma concentration-time curve ( AUC ) of ( R ) - and ( S ) - fexofenadine ( 3.10-fold and 3.48-fold , respectively ) and decreased the renal clearance of ( R ) - and ( S ) - fexofenadine ( 0.40-fold and 0.47-fold , respectively ) , causing marked differences in the mean amounts of these enantiomers excreted into the urine in the rifampicin phase ( P < 0.001 ) .
-CONCLUSIONS	These results indicated that multiple doses of rifampicin 450 mg may be sufficient to inhibit the renal influx transporter and OATP-mediated hepatic uptake of both enantiomers .
-CONCLUSIONS	Moreover , these effects may be greater than the P-gp-inductive effects of rifampicin .
-CONCLUSIONS	Therefore , the interactive mechanism of multidose rifampicin may occur through a combination of OATP and P-gp transporters , thereby altering the pharmacokinetics of fexofenadine enantiomers .
-CONCLUSIONS	In this study of rifampicin 450 mg , the interactive magnitude of the mean AUC values of fexofenadine enantiomers was higher than that observed in the previous study of rifampicin 600 mg , and no dose-dependent inhibitory effects of rifampicin were observed .
-CONCLUSIONS	These effects may be clinically significant in patients receiving fexofenadine and rifampicin .
-
-###24477618
-OBJECTIVE	Since oxidative stress plays a pathogenetic role in chronic neck pain ( CNP ) , we investigated whether a combination of - lipoic acid ( ALA ) and superoxide dismutase ( SOD ) might improve pain control and the efficacy of physiotherapy ( `` multimodal therapy '' ) in patients with CNP .
-METHODS	This study was conducted in the Rehabilitation Unit of the Department of Surgical and Oncological Sciences at the University Policlinic in Palermo , Italy .
-METHODS	This was a prospective , randomized , open study in outpatients .
-METHODS	Patients randomly received either physiotherapy alone ( group 2 ; n = 45 ) or a combination of ALA 600 mg and SOD 140 IU daily in addition to physiotherapy ( group 1 ; n = 51 ) , for 60 days .
-METHODS	Pain was assessed by a visual analogue scale ( VAS ) and a modified Neck Pain Questionnaire ( mNPQ ) .
-METHODS	Treatment compliance and safety were also evaluated .
-RESULTS	Both groups experienced a significant reduction in the VAS and mNPQ scores after 1 month ; however , while no further improvement was observed in group 2 at 60 days , group 1 showed a further VAS reduction ( p < 0.001 ) .
-RESULTS	In addition , in the mNPQ at 60 days , more patients in group 1 than in group 2 reported that their neck pain was improved ( p < 0.01 ) , and they showed greater compliance with prescribed physiotherapy ( p = 0.048 ) .
-RESULTS	No drug reaction was observed .
-CONCLUSIONS	Use of ALA/SOD in combination with physiotherapy may be a useful approach to CNP , being antioxidants that act on nerve inflammation and disease progression .
-CONCLUSIONS	These preliminary observations suggest that some interesting goals ( better pain control and physical wellbeing ) can be achieved by multimodal therapy in CNP patients .
-
-###24654201
-OBJECTIVE	To identify whether advanced cancer patients receiving home hospice care and their primary caregivers view artificial hydration ( AH ) as food or medicine , and the demographic and clinical factors influencing these perceptions .
-METHODS	Participants were enrolled in a randomised , double-blind controlled trial examining the efficacy of AH in cancer hospice patients .
-METHODS	In-depth interviews at days 1 and 4 of study enrolment explored the meanings attributed to AH at the end of life .
-METHODS	Responses to the question , ` Are these fluids more like food or more like medicine ? '
-METHODS	were categorised as ` food ' , ` medicine ' , ` both ' or ` other ' .
-METHODS	( 2 ) analyses were conducted with data from 122 interviews ( 54 patients and 68 caregivers ) to identify differences between patients and caregivers , and by gender , age , ethnicity and caregiver relationship .
-METHODS	Predictors of perceptions were identified using logistic regression analysis .
-RESULTS	Overall , 47 participants ( 38 % ) understood the fluids to be more like food , 41 ( 34 % ) as medicine , 17 ( 14 % ) as both , and 17 ( 14 % ) as ` other ' .
-RESULTS	Ethnic minority participants ( n = 34 , 66 % ) were significantly more likely than non-Hispanic European Americans ( n = 30 , 42 % ) to view AH as food , or both as food and medicine ( p = 0.034 ) .
-RESULTS	Ethnic differences persisted in the final regression model ( OR 2.7 ; 95 % CI 1.3 to 5.7 , p = 0.010 ) .
-RESULTS	No significant differences were detected between patients and caregivers , or across gender , age , caregivers ' relationship to the patients , group assignment , disease severity or cancer type .
-CONCLUSIONS	AH was perceived as food/nutrition by many cancer patients and caregivers in the study , particularly among ethnic minorities .
-CONCLUSIONS	This perception may lead to greater distress if fluids are discontinued or withheld .
-CONCLUSIONS	Asking patients/caregivers about their AH perceptions may enhance patient/provider communication and culturally appropriate end-of-life care .
-
-###24816809
-OBJECTIVE	Whether prasugrel plus bivalirudin is a superior strategy to unfractionated heparin plus clopidogrel in patients with ST-segment elevation myocardial infarction ( STEMI ) undergoing primary percutaneous coronary intervention ( PCI ) has never been assessed in specifically designed randomized trials .
-RESULTS	The Bavarian Reperfusion Alternatives Evaluation ( BRAVE ) 4 study is an investigator-initiated , randomized , open-label , multicentre trial , designed to test the hypothesis that in STEMI patients with planned primary PCI a strategy based on prasugrel plus bivalirudin is superior to a strategy based on clopidogrel plus heparin in terms of net clinical outcome .
-RESULTS	Owing to slow recruitment , the trial was stopped prematurely after enrolment of 548 of 1240 planned patients .
-RESULTS	At 30 days , the primary composite endpoint of death , myocardial infarction , unplanned revascularization of the infarct related artery , stent thrombosis , stroke , or bleeding was observed in 42 patients ( 15.6 % ) randomized to prasugrel plus bivalirudin and 40 patients ( 14.5 % ) randomized to clopidogrel plus heparin [ relative risk , 1.09 ; one-sided 97.5 % confidence interval ( CI ) 0-1 .79 , P = 0.680 ] .
-RESULTS	The composite ischaemic endpoint of death , myocardial infarction , unplanned revascularization of the infarct-related artery , stent thrombosis , or stroke occurred in 13 patients ( 4.8 % ) in the prasugrel plus bivalirudin group and 15 patients ( 5.5 % ) in the clopidogrel plus heparin group ( relative risk , 0.89 ; 95 % CI 0.40-1 .96 , P = 0.894 ) .
-RESULTS	Bleeding according to the HORIZONS-AMI definition was observed in 38 patients ( 14.1 % ) in the prasugrel plus bivalirudin group and 33 patients ( 12.0 % ) in the clopidogrel plus heparin group ( relative risk , 1.18 ; 95 % CI 0.74-1 .88 , P = 0.543 ) .
-RESULTS	Results were consistent across various subgroups of patients .
-CONCLUSIONS	In this randomized trial of STEMI patients , we were unable to demonstrate significant differences in net clinical outcome between prasugrel plus bivalirudin and clopidogrel plus heparin .
-CONCLUSIONS	Neither the composite of ischaemic complications nor bleeding were favourably affected by prasugrel plus bivalirudin compared with a regimen of clopidogrel plus unfractionated heparin .
-CONCLUSIONS	However , the results must be interpreted in view of the premature termination of the trial .
-BACKGROUND	Unique identifier NCT00976092 ( www.clinicaltrials.gov ) .
-
-###25815420
-OBJECTIVE	The ABCB1 gene encodes P-glycoprotein , which limits brain concentrations of certain antidepressants .
-OBJECTIVE	ABCB1 variation has been associated with antidepressant efficacy and side effects in small-sample studies .
-OBJECTIVE	Cognitive impairment in major depressive disorder predicts poor treatment outcome , but ABCB1 genetic effects in patients with cognitive impairment are untested .
-OBJECTIVE	The authors examined ABCB1 genetic variants as predictors of remission and side effects in a large clinical trial that also incorporated cognitive assessment .
-METHODS	The authors genotyped 10 ABCB1 single-nucleotide polymorphisms ( SNPs ) in 683 patients with major depressive disorder treated for at least 2 weeks , of whom 576 completed 8 weeks of treatment with escitalopram , sertraline , or extended-release venlafaxine ( all substrates for P-glycoprotein ) in a large randomized , prospective , pragmatic trial .
-METHODS	Antidepressant efficacy was assessed with the 16-item Quick Inventory of Depressive Symptomatology-Self-Rated ( QIDS-SR ) , and side effects with a rating scale for frequency , intensity , and burden of side effects .
-METHODS	General and emotional cognition was assessed with a battery of 13 tests .
-RESULTS	The functional SNP rs10245483 upstream from ABCB1 had a significant effect on remission and side effect ratings that was differentially related to medication and cognitive status .
-RESULTS	Common homozygotes responded better and had fewer side effects with escitalopram and sertraline .
-RESULTS	Minor allele homozygotes responded better and had fewer side effects with venlafaxine , with the better response most apparent for patients with cognitive impairment .
-CONCLUSIONS	The functional polymorphism rs10245483 differentially affects remission and side effect outcomes depending on the antidepressant .
-CONCLUSIONS	The predictive power of the SNP for response or side effects was not lessened by the presence of cognitive impairment .
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-###24983382
-BACKGROUND	Currently there is no evidence on the effectiveness of Individual Placement and Support ( IPS ) in Sweden .
-OBJECTIVE	To determine the effectiveness of IPS on vocational outcomes among people with severe mental illness ( SMI ) in a Swedish context .
-OBJECTIVE	A secondary aim was to evaluate a community integration effect .
-METHODS	A randomized controlled trial with a parallel design was used .
-METHODS	Mental health outpatients with SMI were randomized to IPS or traditional vocational rehabilitation ( TVR ) services .
-METHODS	The allocation status was assessor-blinded .
-METHODS	The primary outcome was competitive employment .
-METHODS	All vocational outcomes were collected continuously , and socio-demographic and clinical variables at baseline , 6 and 18 months .
-METHODS	The trial is registered with ClinicalTrials.gov : NCT00960024 .
-RESULTS	One hundred and twenty participants were randomized .
-RESULTS	Eighty seven per cent were assessed after 6 months , and 73 % after 18 months .
-RESULTS	IPS was more effective than TVR in terms of gaining employment at 18-month follow-up ( 46 % vs. 11 % ; difference 36 % , 95 % CI 18-54 ) , along with the amount of working hours and weeks , longer job tenure periods and income .
-RESULTS	Cox regression analysis showed that IPS participants gained employment five times quicker than those in TVR .
-RESULTS	Ninety per cent of the IPS participants became involved in work , internships or education , i.e. activities integrated in mainstream community settings , while 24 % in the TVR group achieved this .
-CONCLUSIONS	IPS is effective in a Swedish context in terms of gaining employment and becoming integrated within the local community .
-CONCLUSIONS	The welfare system presented obstacles for gaining competitive employment directly and it was indicated that internships delayed time to first competitive employment .
-
-###25533656
-BACKGROUND	Treatments for open-angle glaucoma aim to prevent vision loss through lowering of intraocular pressure , but to our knowledge no placebo-controlled trials have assessed visual function preservation , and the observation periods of previous ( unmasked ) trials have typically been at least 5 years .
-BACKGROUND	We assessed vision preservation in patients given latanoprost compared with those given placebo .
-METHODS	In this randomised , triple-masked , placebo-controlled trial , we enrolled patients with newly diagnosed open-angle glaucoma at ten UK centres ( tertiary referral centres , teaching hospitals , and district general hospitals ) .
-METHODS	Eligible patients were randomly allocated ( 1:1 ) with a website-generated randomisation schedule , stratified by centre and with a permuted block design , to receive either latanoprost 0005 % ( intervention group ) or placebo ( control group ) eye drops .
-METHODS	Drops were administered from identical bottles , once a day , to both eyes .
-METHODS	The primary outcome was time to visual field deterioration within 24 months .
-METHODS	Analyses were done in all individuals with follow-up data .
-METHODS	The Data and Safety Monitoring Committee ( DSMC ) recommended stopping the trial on Jan 6 , 2011 ( last patient visit July , 2011 ) , after an interim analysis , and suggested a change in primary outcome from the difference in proportions of patients with incident progression between groups to time to visual field deterioration within 24 months .
-METHODS	This trial is registered , number ISRCTN96423140 .
-RESULTS	We enrolled 516 individuals between Dec 1 , 2006 , and March 16 , 2010 .
-RESULTS	Baseline mean intraocular pressure was 196 mm Hg ( SD 46 ) in 258 patients in the latanoprost group and 201 mm Hg ( 48 ) in 258 controls .
-RESULTS	At 24 months , mean reduction in intraocular pressure was 38 mm Hg ( 40 ) in 231 patients assessed in the latanoprost group and 09 mm Hg ( 38 ) in 230 patients assessed in the placebo group .
-RESULTS	Visual field preservation was significantly longer in the latanoprost group than in the placebo group : adjusted hazard ratio ( HR ) 044 ( 95 % CI 028-069 ; p = 00003 ) .
-RESULTS	We noted 18 serious adverse events , none attributable to the study drug .
-CONCLUSIONS	This is the first randomised placebo-controlled trial to show preservation of the visual field with an intraocular-pressure-lowering drug in patients with open-angle glaucoma .
-CONCLUSIONS	The study design enabled significant differences in vision to be assessed in a relatively short observation period .
-BACKGROUND	Pfizer , UK National Institute for Health Research Biomedical Research Centre .
-
-###24527599
-OBJECTIVE	To explore the therapeutic effect of Neurac training on patients with cervical radiculopathy ( CR ) .
-METHODS	Sixty patients with CR were enrolled and randomly assigned into control group ( CG ) and Neurac training group ( NG ) with 30 patients for each group .
-METHODS	The patients in CG group received conventional treatments for 2 weeks , including cervical traction , manual therapy and electrical therapy .
-METHODS	The patients in NG group received Neurac training as well as conservative treatments for 2 weeks .
-METHODS	The pain level and it impact on daily life were assessed by the numerical pain rating scale ( NPRS ) and the neck disability index ( NDI ) before the treatments and at the time of 1 week , 2 weeks after the treatments , respectively .
-RESULTS	Following the treatment , significant improvements for NPRS and NDI were observed in both the two groups at the end of the first and second week .
-RESULTS	The improvements for both NPRS and NDI were higher in the NG than those in the CG , with P < 0.05 .
-CONCLUSIONS	The results of this study indicate that Neurac training can bring additional therapeutic benefits to conventional treatments for patients with CR .
-
-###24928217
-BACKGROUND	Implementation of interventions in real-life settings requires a comprehensive evaluation approach .
-BACKGROUND	The aim of this article is to describe the evaluation design of the SLIMMER diabetes prevention intervention in a Dutch real-life setting .
-METHODS	The SLIMMER study is a randomised , controlled intervention study including subjects aged 40 through 70years with impaired fasting glucose or high risk of diabetes .
-METHODS	The 10-month SLIMMER intervention involves a dietary and physical activity intervention , including case management and a maintenance programme .
-METHODS	The control group receives usual health care and written information about a healthy lifestyle .
-METHODS	A logic model of change is composed to link intervention activities with intervention outcomes in a logical order .
-METHODS	Primary outcome is fasting insulin .
-METHODS	Measurements are performed at baseline and after 12 and 18months and cover quality of life , cardio-metabolic risk factors ( e.g. glucose tolerance , serum lipids , body fatness , and blood pressure ) , eating and physical activity behaviour , and behavioural determinants .
-METHODS	A process evaluation gives insight in how the intervention was delivered and received by participants and health care professionals .
-METHODS	The economic evaluation consists of a cost-effectiveness analysis and a cost-utility analysis .
-METHODS	Costs are assessed from both a societal and health care perspective .
-CONCLUSIONS	This study is expected to provide insight in the effectiveness , including its cost-effectiveness , and delivery of the SLIMMER diabetes prevention intervention conducted in Dutch primary health care .
-CONCLUSIONS	Results of this study provide valuable information for primary health care professionals , researchers , and policy makers .
-BACKGROUND	The SLIMMER study is registered with ClinicalTrials.gov ( NCT02094911 ) since March 19 , 2014 .
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-###25367539
-BACKGROUND	Unconditional regard refers to the feeling that one is accepted and valued by others without conditions .
-BACKGROUND	Psychological theory suggests that experiences of unconditional regard lead children to feel that they are valuable despite setbacks .
-BACKGROUND	We hypothesized that reflecting on experiences of unconditional regard would buffer children 's negative self-feelings ( eg , shame , insecurity , powerlessness ) in the face of setbacks .
-BACKGROUND	To test this hypothesis , we randomized children to reflect on experiences of unconditional regard or other experiences , and examined their response to an academic setback 3 weeks later .
-METHODS	Participants ( 11-15 years old ) were randomly assigned to reflect for 15 minutes on experiences of unconditional regard ( n = 91 ) , conditional regard ( n = 80 ) , or other social experiences ( n = 76 ) .
-METHODS	Research personnel , teachers , and classmates remained blind to condition assignment .
-METHODS	Three weeks later , after receiving their course grades , children reported their self-feelings .
-METHODS	Course grades were obtained from school records .
-METHODS	Receiving low course grades represents a salient and painful real-world setback for children .
-RESULTS	Replicating previous research , children who received lower grades experienced more negative self-feelings ( P < .001 ) .
-RESULTS	As predicted , this well-established relationship was significantly attenuated among children who had reflected , 3 weeks previously , on experiences of unconditional regard ( Ps < .03 ) .
-RESULTS	Reflecting on unconditional regard specifically reduced negative self-feelings after low grades ( P = .01 ) , not after average or high grades ( Ps > .17 ) .
-CONCLUSIONS	Reflecting on unconditional regard buffered children 's selves against the adverse impact of an academic setback over an extended period of time .
-CONCLUSIONS	Unconditional regard may thus be an important psychological lever to reduce negative self-feelings in youth .
-
-###25173752
-OBJECTIVE	The intestine efficiently incorporates and rapidly secretes dietary fat as chylomicrons ( lipoprotein particles comprising triglycerides , phospholipids , cholesterol , and proteins ) that contain the apolipoprotein isoform apoB-48 .
-OBJECTIVE	The gut can store lipids for many hours after their ingestion , and release them in chylomicrons in response to oral glucose , sham feeding , or unidentified stimuli .
-OBJECTIVE	The gut hormone glucagon-like peptide-2 ( GLP-2 ) facilitates intestinal absorption of lipids , but its role in chylomicron secretion in human beings is unknown .
-METHODS	We performed a randomized , single-blind , cross-over study , with 2 study visits 4 weeks apart , to assess the effects of GLP-2 administration on triglyceride-rich lipoprotein ( TRL ) apoB-48 in 6 healthy men compared with placebo .
-METHODS	Subjects underwent constant intraduodenal feeding , with a pancreatic clamp and primed constant infusion of deuterated leucine .
-METHODS	In a separate randomized , single-blind , cross-over validation study , 6 additional healthy men ingested a high-fat meal containing retinyl palmitate and were given either GLP-2 or placebo 7 hours later with measurement of TRL triglyceride , TRL retinyl palmitate , and TRL apoB-48 levels .
-RESULTS	GLP-2 administration resulted in a rapid ( within 30 minutes ) and transient increase in the concentration of TRL apoB-48 , compared with placebo ( P = .03 ) .
-RESULTS	Mathematic modeling of stable isotope enrichment and the mass of the TRL apoB-48 suggested that the increase resulted from the release of stored , presynthesized apoB-48 from the gut .
-RESULTS	In the validation study , administration of GLP-2 at 7 hours after the meal , in the absence of additional food intake , robustly increased levels of TRL triglycerides ( P = .007 ) , TRL retinyl palmitate ( P = .002 ) , and TRL apoB-48 ( P = .04 ) compared with placebo .
-CONCLUSIONS	Administration of GLP-2 to men causes the release of chylomicrons that comprise previously synthesized and stored apoB-48 and lipids .
-CONCLUSIONS	This transiently increases TRL apoB-48 levels compared with placebo .
-CONCLUSIONS	Clinical trials number at www.clinicaltrials.gov : NCT 01958775 .
-
-###24636395
-OBJECTIVE	To determine the effects of high-dose vitamin D on insulin sensitivity in polycystic ovary syndrome ( PCOS ) .
-METHODS	Randomized , placebo-controlled trial .
-METHODS	Academic medical center .
-METHODS	Twenty-eight women with PCOS .
-METHODS	Vitamin D3 , 12,000 IU , or placebo daily for 12 weeks .
-METHODS	The primary outcome was quantitative insulin sensitivity check index .
-METHODS	Secondary outcomes included glucose and insulin levels during a 75-g oral glucose tolerance test and blood pressure .
-RESULTS	Twenty-two women completed the study .
-RESULTS	Compared with placebo , vitamin D significantly increased 25-hydroxyvitamin D ( mean [ 95 % confidence interval ] in vitamin D group 20.1 [ 15.7 to 24.5 ] ng/mL at baseline and 65.7 [ 52.3 to 79.2 ] ng/mL at 12 weeks ; placebo 22.5 [ 18.1 to 26.8 ] ng/mL at baseline and 23.8 [ 10.4 to 37.2 ] ng/mL at 12 weeks ) .
-RESULTS	There were no significant differences in quantitative insulin sensitivity check index and other measures of insulin sensitivity ; however , we observed trends toward lower 2-hour insulin and lower 2-hour glucose .
-RESULTS	We also observed a protective effect of vitamin D on blood pressure .
-CONCLUSIONS	In women with PCOS , insulin sensitivity was unchanged with high-dose vitamin D , but there was a trend toward decreased 2-hour insulin and a protective effect on blood pressure .
-BACKGROUND	NCT00907153 .
-
-###25475464
-BACKGROUND	The 2012 Guidelines for Diagnosis and Management of Patients with Stable Ischemic Heart Disease recommend intensive antianginal and risk factor treatment ( optimal medical management [ OMT ] ) before considering revascularization to relieve symptoms .
-BACKGROUND	The Bypass Angioplasty Revascularization Investigation 2 Diabetes ( BARI 2D ) trial randomized patients with ischemic heart disease and anatomy suitable to revascularization to ( 1 ) initial OMT with revascularization if needed or ( 2 ) initial revascularization plus OMT and found no difference in major cardiovascular events .
-BACKGROUND	Ultimately , however , 37.9 % of the OMT group was revascularized during the 5-year follow-up period .
-METHODS	Data from the 1192 patients randomized to OMT were analyzed to identify subgroups in which the incidence of revascularization was so high that direct revascularization without a trial period could be justified .
-METHODS	Multivariate logistic analysis , Cox regression models of baseline data , and a landmark analysis of participants who did not undergo revascularization at 6 months were constructed .
-RESULTS	The models that used only data available at the time of study entry had limited predictive value for revascularization by 6 months or by 5 years ; however , the model incorporating severity of angina during the first 6 months could better predict revascularization ( C statistic = 0.789 ) .
-CONCLUSIONS	With the possible exception of patients with severe angina and proximal left anterior descending artery disease , this analysis supports the recommendation of the 2012 guidelines for a trial of OMT before revascularization .
-CONCLUSIONS	Patients could not be identified at the time of catheterization , but a short period of close follow-up during OMT identified the nearly 40 % of patients who underwent revascularization .
-
-###24857356
-BACKGROUND	There is no head on comparison of amitriptyline ( AMT ) and pregabalin ( PG ) in relieving pain and disability in chronic low backache ( CLBA ) .
-BACKGROUND	This randomized controlled trial reports the efficacy and safety of AMT and PG in CLBA .
-METHODS	Patients with CLBA , 15-65 years of age without specific cause and significant neurological deficit were included .
-METHODS	Severity of pain was assessed by Visual Analogue Scale ( VAS ) and disability by Oswestry Disability Index ( ODI ) .
-METHODS	Patients were followed up at 6 and 14 weeks and their VAS score , ODI and side effect were noted .
-METHODS	Primary outcome was pain relief ( > 50 % improvement in VAS score ) at 14 weeks and secondary outcome were reduction in ODI ( > 20 % ) and side effects .
-RESULTS	200 patients with CLBA were randomized to AMT ( n = 103 ) and PG ( n = 97 ) using random numbers .
-RESULTS	The VAS score and ODI improved significantly following AMT and PG at 6 and 14 weeks compared to baseline .
-RESULTS	The improvement in pain ( 57.3 % Vs 39.2 % ; P = 0.01 ) and disability ( 65 % Vs 49.5 % ; P = 0.03 ) however was more in AMT group .
-RESULTS	The composite side effects were similar in both groups .
-CONCLUSIONS	AMT and PG are effective in CLBA but AMT reduced pain and disability significantly compared to PG .
-
-###24225010
-BACKGROUND	Neck pain , common among the elderly population , has considerable implications on health and quality of life .
-BACKGROUND	Evidence supports the use of spinal manipulative therapy ( SMT ) and exercise to treat neck pain ; however , no studies to date have evaluated the effectiveness of these therapies specifically in seniors .
-OBJECTIVE	To assess the relative effectiveness of SMT and supervised rehabilitative exercise , both in combination with and compared to home exercise ( HE ) alone for neck pain in individuals ages 65 years or older .
-METHODS	Randomized clinical trial .
-METHODS	Individuals 65 years of age or older with a primary complaint of mechanical neck pain , rated 3 ( 0-10 ) for 12 weeks or longer in duration .
-METHODS	Patient self-report outcomes were collected at baseline and 4 , 12 , 26 , and 52 weeks after randomization .
-METHODS	The primary outcome was pain , measured by an 11-box numerical rating scale .
-METHODS	Secondary outcomes included disability ( Neck Disability Index ) , general health status ( Medical Outcomes Study Short Form-36 ) , satisfaction ( 7-point scale ) , improvement ( 9-point scale ) , and medication use ( days per week ) .
-METHODS	This study was funded by the US Department of Health and Human Services , Health Resources and Services Administration .
-METHODS	Linear mixed model analyses were used for comparisons at individual time points and for short - and long-term analyses .
-METHODS	Blinded evaluations of objective outcomes were performed at baseline and 12 weeks .
-METHODS	Adverse event data were collected at each treatment visit .
-RESULTS	A total of 241 participants were randomized , with 95 % reporting primary outcome data at all time points .
-RESULTS	After 12 weeks of treatment , the SMT with home exercise group demonstrated a 10 % greater decrease in pain compared with the HE-alone group , and 5 % change over supervised plus home exercise .
-RESULTS	A decrease in pain favoring supervised plus HE over HE alone did not reach statistical significance .
-RESULTS	Compared with the HE group , both combination groups reported greater improvement at week 12 and more satisfaction at all time points .
-RESULTS	Multivariate longitudinal analysis incorporating primary and secondary patient-rated outcomes showed that the SMT with HE group was superior to the HE-alone group in both the short - and long-term .
-RESULTS	No serious adverse events were observed as a result of the study treatments .
-CONCLUSIONS	SMT with HE resulted in greater pain reduction after 12 weeks of treatment compared with both supervised plus HE and HE alone .
-CONCLUSIONS	Supervised exercise sessions added little benefit to the HE-alone program .
-
-###25877710
-OBJECTIVE	To evaluate the safety , effectiveness and compliance of Bronuck ( bromfenac sodium ophthalmic solution 0.1 % ) following LASEK in comparison with glucocorticoids .
-METHODS	In this prospective trial , 60 patients ( 120 eyes ) undergoing LASEK were randomized into the bromfenac sodium group ( 60 eyes ) and control group ( 60 eyes ) .
-METHODS	Patients in both groups initially received dexamethasone 0.1 % four times a day after LASEK for 7 days , and then the patients in the bromfenac sodium group were given Bronuck twice a day for the next 11 weeks , while the patients from the control group were given fluorometholone 0.1 % with gradually decreased doses during the same period .
-METHODS	Results of the routine examinations done before and 3 , 10 , 30 , 90 and 180 days after LASEK were recorded , including uncorrected visual acuity , best corrected visual acuity , intraocular pressure ( IOP ) , corneal topography , ocular symptoms and signs , which were used for comparison between the two groups .
-METHODS	All data of right eyes were analyzed for their independence , normality and homogeneity of variance .
-METHODS	Independent samples t-test or non-parametric Mann-Whitney test was performed accordingly .
-RESULTS	There was no statistically significant difference in IOP and corneal topography ( K1 , K2 , SAI , SRI and CY ) between the two groups postoperatively .
-RESULTS	The IOP was ( 16.33 6.21 ) mmHg ( 1 mmHg = 0.133 kPa ) , ( 15.67 2.82 ) mmHg , ( 15.35 2.22 ) mmHg and ( 13.10 3.41 ) mmHg in the bromfenac sodium group , and ( 16.87 3.68 ) mmHg , ( 14.05 2.23 ) mmHg , ( 14.39 2.22 ) mmHg and ( 13.18 2.49 ) mmHg in the control group at 10 , 30 , 90 and 180 days , respectively .
-RESULTS	The bromfenac sodium group showed significantly better uncorrected visual acuity ( 5.16 0.08 ) than the control group ( 5.02 0.09 ) on day 30 ( t = 2.32 , P < 0.05 ) .
-RESULTS	In the bromfenac sodium group , four eyes had visual fatigue , and four eyes had dry eye symptoms on day 180 .
-RESULTS	Epithelial flaps were all well positioned with satisfying healing process .
-RESULTS	Each group had one case ( two eyes ) of haze on day 30 , and the bromfenac sodium group had another case ( 2 eyes ) of new-onset haze on day 60 .
-RESULTS	But all the cases of haze were graded 0.5 according to the Fantes Standard , too mild to compromise their visual acuities , and were resolved after frequent topical medication for 1 month .
-RESULTS	Four patients from the control group were prescribed antiglaucoma medications due to elevated IOP .
-RESULTS	The refractive status remained stable for patients from both groups .
-CONCLUSIONS	Administration of Bronuck can reduce the amount of or partially substitute for corticosteroids .
-CONCLUSIONS	Mild haze early after LASEK may disappear after intensive treatment .
-
-###25073921
-OBJECTIVE	In vitro and animal model data suggest that intraoperative preservation solutions may influence endothelial function and vein graft failure ( VGF ) after coronary artery bypass graft ( CABG ) surgery .
-OBJECTIVE	Clinical studies to validate these findings are lacking .
-OBJECTIVE	To evaluate the effect of vein graft preservation solutions on VGF and clinical outcomes in patients undergoing CABG surgery .
-METHODS	Data from the Project of Ex-Vivo Vein Graft Engineering via Transfection IV ( PREVENT IV ) study , a phase 3 , multicenter , randomized , double-blind , placebo-controlled trial that enrolled 3014 patients at 107 US sites from August 1 , 2002 , through October 22 , 2003 , were used .
-METHODS	Eligibility criteria for the trial included CABG surgery for coronary artery disease with at least 2 planned vein grafts .
-METHODS	Preservation of vein grafts in saline , blood , or buffered saline solutions .
-METHODS	One-year angiographic VGF and 5-year rates of death , myocardial infarction , and subsequent revascularization .
-RESULTS	Most patients had grafts preserved in saline ( 1339 [ 44.4 % ] ) , followed by blood ( 971 [ 32.2 % ] ) and buffered saline ( 507 [ 16.8 % ] ) .
-RESULTS	Baseline characteristics were similar among groups .
-RESULTS	One-year VGF rates were much lower in the buffered saline group than in the saline group ( patient-level odds ratio [ OR ] , 0.59 [ 95 % CI , 0.45-0 .78 ; P < .001 ] ; graft-level OR , 0.63 [ 95 % CI , 0.49-0 .79 ; P < .001 ] ) or the blood group ( patient-level OR , 0.62 [ 95 % CI , 0.46-0 .83 ; P = .001 ] ; graft-level OR , 0.63 [ 95 % CI , 0.48-0 .81 ; P < .001 ] ) .
-RESULTS	Use of buffered saline solution also tended to be associated with a lower 5-year risk for death , myocardial infarction , or subsequent revascularization compared with saline ( hazard ratio , 0.81 [ 95 % CI , 0.64-1 .02 ; P = .08 ] ) and blood ( 0.81 [ 0.63-1 .03 ; P = .09 ] ) solutions .
-CONCLUSIONS	Patients undergoing CABG whose vein grafts were preserved in a buffered saline solution had lower VGF rates and trends toward better long-term clinical outcomes compared with patients whose grafts were preserved in saline - or blood-based solutions .
-BACKGROUND	clinicaltrials.gov Identifier : NCT00042081 .
-
-###24240647
-BACKGROUND	Fatigue is the most common and disabling symptom affecting quality of life ( QOL ) and daily function in patients who have completed treatment for acute myeloid leukemia ( AML ) .
-BACKGROUND	Although trials in patients with various solid tumors have reported improved fatigue and QOL following exercise interventions , there have been no studies in AML patients post treatment .
-METHODS	Forty patients aged 40 years who had completed treatment for AML were enrolled in a 12-week randomized phase II exercise intervention to determine feasibility ( recruitment , retention , and adherence ) , efficacy , and safety of the intervention .
-METHODS	Patients assigned to the exercise group received an individualized , moderate-intensity , 12-week home-based exercise program with weekly telephone support from a certified exercise physiologist .
-METHODS	QOL , fatigue , and fitness outcomes were measured at baseline , 6 weeks , and 12 weeks .
-METHODS	Between-group differences in 12-week change scores were calculated using linear regression adjusting for age and baseline function .
-RESULTS	Recruitment and retention rates were 38 % and 91 % , respectively .
-RESULTS	Adherence was low at 28 % .
-RESULTS	Analyses did not suggest statistically significant or clinically important benefits in QOL , fatigue , or physical fitness with the intervention .
-RESULTS	The level of adherence did not appear to impact outcomes .
-RESULTS	There were no adverse events .
-CONCLUSIONS	A home-based exercise program for post-treatment AML patients age 40 years or older can be safely delivered with reasonable recruitment and high retention .
-CONCLUSIONS	However , feasibility was hampered by low adherence .
-CONCLUSIONS	Further research and program modification are needed to better understand and overcome barriers to exercise delivery and adherence in AML survivors .
-
-###25625133
-OBJECTIVE	To evaluate the 3-year clinical durability of the flowable bulk-fill resin composite SDR in Class I and Class II restorations .
-METHODS	Thirty-eight pairs of Class I and 62 pairs of Class II restorations were placed in 44 male and 42 female patients ( mean age 52.4 years ) .
-METHODS	Each patient received at least two extended Class I or Class II restorations that were as similar as possible .
-METHODS	In all cavities , a one-step self-etching adhesive ( XenoV + ) was applied .
-METHODS	One of the cavities of each pair was randomly assigned to receive the flowable bulk-fill resin composite SDR in increments up to 4 mm as needed to fill the cavity 2 mm short of the occlusal cavosurface .
-METHODS	The occlusal part was completed with an ormocer-based nanohybrid resin composite ( Ceram X mono + ) .
-METHODS	In the other cavity , only the resin composite CeramX mono + was placed in 2 mm increments .
-METHODS	The restorations were evaluated using slightly modified USPHS criteria at baseline and then annually for 3 years .
-METHODS	Caries risk and bruxing habits of the participants were estimated .
-RESULTS	No post-operative sensitivity was reported .
-RESULTS	At the 3-year follow-up , 196 restorations - 74 Class I and 122 Class II - were evaluated .
-RESULTS	Seven restorations failed ( 3.6 % ) , 4 SDR-CeramX mono + and 3 CeramX mono + only restorations , all of which were Class II .
-RESULTS	The main reason for failure was tooth fracture , followed by resin composite fracture .
-RESULTS	The annual failure rate ( AFR ) for all restorations ( Class I and II ) was 1.2 % for the bulkfilled restorations and 1.0 % for the resin composite-only restorations ( p > 0.05 ) .
-RESULTS	For the Class II restorations , the AFR was 2.2 % and 1.6 % , respectively .
-CONCLUSIONS	The 4-mm bulk-fill technique showed good clinical effectiveness during the 3-year follow-up .
-
-###24445278
-OBJECTIVE	Tadalafil significantly improves lower urinary tract symptoms suggestive of benign prostatic hyperplasia .
-OBJECTIVE	We post hoc characterized changes in the maximum urinary flow rate using integrated data from 4 international , placebo controlled studies of tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia .
-METHODS	After a 4-week placebo lead-in period 1,500 men were randomized to tadalafil 5 mg or placebo for 12 weeks .
-METHODS	Data were analyzed using ANCOVA .
-METHODS	Maximum urinary flow rate values were rank transformed for analysis .
-RESULTS	Baseline maximum urinary flow rate data were available on 1,371 men with a mean age of 63.1 years and end point data were available on 1,197 .
-RESULTS	Tadalafil 5 mg significantly increased maximum urinary flow vs placebo ( median 1.1 vs 0.4 ml per second , p = 0.003 ) .
-RESULTS	At a baseline voided volume of 125 to less than 250 ml the median change in the maximum urinary flow rate was 0.9 and 1.2 ml per second ( p = 0.142 ) in 731 patients , at a baseline of 250 to 450 ml the change was -0.3 and 0.7 ml per second ( p = 0.011 ) in 428 , and at a baseline of greater than 450 ml the change was -0.2 and 2.0 ml per second ( p = 0.186 ) in 38 for placebo and tadalafil , respectively .
-RESULTS	The difference was 0.3 , 1.0 and 2.2 ml per second , respectively .
-RESULTS	At a baseline maximum urinary flow rate of greater than 15 ml per second in 128 patients the median flow rate change was -2.1 and -0.8 ml per second ( p = 0.246 ) , at a maximum of 10 to 15 ml per second in 522 the change was 0.2 and 0.8 ml per second ( p = 0.044 ) , and at a maximum of less than 10 ml per second in 547 the change was 1.2 and 1.8 ml per second ( p = 0.189 ) for placebo and tadalafil , respectively .
-RESULTS	Tadalafil improved I-PSS ( International Prostate Symptom Score ) voiding subscores significantly vs placebo across all baseline maximum urinary flow subgroups ( each p < 0.001 ) .
-CONCLUSIONS	This integrated analysis revealed a small but statistically significant median maximum urinary flow rate improvement for tadalafil vs placebo .
-CONCLUSIONS	The numerical difference in the maximum urinary flow change from baseline between tadalafil and placebo increased with increased voided volume .
-
-###25171966
-BACKGROUND	It has been hypothesized that incomplete endothelialization and delayed vascular healing may trigger stent thrombosis events after drug-eluting stent ( DES ) implantation .
-BACKGROUND	We aimed to demonstrate non-inferiority in terms of neointimal coverage of novel Cre8 DES at 3 months , compared to Vision/Multilink8 Bare Metal Stent ( BMS ) at 1month .
-METHODS	The ranDomizEd coMparisOn betweeN novel Cre8 DES and BMS to assess neoinTimal coveRAge by OCT Evaluation ( DEMONSTRATE ) was a multicenter , randomized , parallel group study .
-METHODS	Thirty-eight patients undergoing angioplasty of de-novo coronary lesion were randomized to Cre8 ( 19 ) or Vision/Multilink8 ( 19 ) stent placement at 6 OCT-experienced centers .
-METHODS	Primary end-point was the Ratio of Uncovered to Total Stent Struts Per Cross Section ( RUTTS ) score of < 30 % , determined by OCT at 3 and 1 months for Cre8 and Vision/Multilink8 , respectively .
-METHODS	Percentage of uncovered/malapposed stent struts , neointimal growth and thickness were the main secondary end-points .
-RESULTS	The primary end-point of RUTTS score < 30 % occurred in 99.8 % ( 899/901 ) of Cre8 struts and in 99.6 % ( 1116/1121 ) of Vision/Multilink8 struts ( difference 0.2 , CI 95 % -0.2 to 0.6 , p for noninferiority < 0.001 ) .
-RESULTS	The percentage of uncovered/malapposed struts was comparable ( 0.360.64 vs. 0.120.24 , p = 0.145 ) in the two study groups , while both neointimal percentage area ( 8.465.29 vs. 19.8415.93 , p < 0.001 ) and thickness ( 0.070.04 vs. 0.160.12 , p < 0.001 ) were significantly reduced by Cre8 stent .
-CONCLUSIONS	The Cre8 DES at 3 months has comparable strut coverage to Vision/Multilink8 BMS at 1 month while preserving a greater efficacy in neo-intima formation reduction .
-CONCLUSIONS	Further studies to assess clinical implication of these Cre8 characteristics are warranted .
-
-###26390724
-OBJECTIVE	To determine predictors for decision-making on a differential approach to choosing glucocorticosteroids ( GCS ) for children and adolescents with acute lymphoblastic leukemia ( ALL ) .
-METHODS	The analysis covered 1064 primary patients aged to 1 to 18 years with ALL who had been registered at the clinics of Russia and Belorussia in April 2002 to November 2006 .
-METHODS	Before induction therapy , the patients were randomized into a dexamethasone ( DEXA ) 6 mg/m2 group ( n = 539 ) and a methylprednisolone ( MePRED ) 60 mg/m2 one ( n = 525 ) .
-RESULTS	The entire group showed no statistically significant differences in survival rates between the patients receiving DEXA or MePRED .
-RESULTS	However , an analysis of age groups revealed the benefits of DEXA in children younger than 14 years ( the event-free survival ( EFS ) was 762 and 712 % , respectively ( p = 0.048 ) ; the overall survival ( OS ) was 812 and 772 % , respectively ( p = 0.046 ) ; therapy-induced mortality was 6.4 % ( DEXA ) andl 1.1 % ( MePRED ) ( p = 0.01 4 ) ; the rate of isolated extramedullary relapses was 1.5 % ( DEXA ) and 4.4 % ( MePRED ) ( p = 0.009 ) .
-RESULTS	At the same time , EFS and OS in 14-to-18-year-old adolescents were statistically significantly higher than in those who used MePRED ( EFS , 656 and 526 % , respectively ( p = 0.087 ) ; OS , 726 and 616 % , respectively ; ( p = 0 .
-RESULTS	l 7 ) .
-CONCLUSIONS	The findings suggest that it is possible that the choice of a GCS for ALL therapy must be also based on a patient 's age .
-CONCLUSIONS	There is a need for further studies of this matter in prospective randomized multicenter trials in children and adolescents .
-
-###24378018
-BACKGROUND	Community case management of malaria ( CCMm ) and seasonal malaria chemoprevention ( SMC ) are anti-malarial interventions that can lead to substantial reduction in malaria burden acting in synergy .
-BACKGROUND	However , little is known about the social acceptability of these interventions .
-BACKGROUND	A study was undertaken to assess whether combining the interventions would be an acceptable approach to malaria control for community health workers ( CHWs ) .
-METHODS	Sixty-one interviews and six focus group discussions were conducted nested in a cluster-randomized trial assessing the impact of combining CCMm and SMC in a rural area of Senegal .
-METHODS	Participants consisted of : ( i ) members of village associations , ( ii ) members of families who had access to the interventions as well as members of families who did not access the interventions , ( iii ) CHWs , and ( iv ) community leaders , e g , religious guides and village chiefs .
-RESULTS	The interventions were acceptable to the local population and perceived as good strategy to make health care services available to community members and thus , to reduce the delays in access to anti-malarial treatment as well as expenses related to patients ' transfer to the health post .
-RESULTS	The use of malaria rapid diagnostic test ( RDT ) contributed to improving CHWs diagnostic capacity as well as malaria treatment practices .
-RESULTS	Study participants notified RDT and drugs stock-out as the major risk for sustainability of the intervention at community level .
-CONCLUSIONS	Combining CCMm and SMC is a well accepted , community-based approach that can contribute to control malaria in areas where malaria transmission is seasonal .
-
-###24895001
-OBJECTIVE	Inappropriate drug prescription is a common problem in people living in nursing homes and is linked to adverse health outcomes .
-OBJECTIVE	This study assessed the effect of an educational intervention directed to nursing home physicians in reducing inappropriate prescription and improving health outcomes and resource utilization .
-METHODS	Prospective , randomized , multicenter study .
-METHODS	A private organization of nursing homes in Spain .
-METHODS	Sixty nursing home physicians caring for approximately 3900 nursing home residents in 37 centers were randomized to receive an educational intervention ( 30 ) or as a control group ( 30 ) .
-METHODS	10 hours educational program , followed by on demand support by phone .
-METHODS	Outcomes were assessed in 1018 randomly selected nursing home residents .
-METHODS	Appropriateness of drug use [ measured by the Screening Tool of Older Persons Prescriptions ( STOPP ) and Screening Tool to Alert Doctors to Right Treatment ( START ) criteria ] , incidence of selected geriatric syndromes ( falls , delirium ) and health resource utilization ( visits to physicians and nursing homes , visits to the emergency room , days of hospitalization ) were recorded for 3 months before the intervention started and 3 months after the intervention finished .
-RESULTS	O total of 716 residents finished the study ( 344 cared for by the intervention group physicians , 372 cared for by control physicians ) .
-RESULTS	Mean age was 84.4 12.7 years ; 73 % were women .
-RESULTS	The mean number of inappropriate drugs ( STOPP criteria ) was higher at the end of the study in the control than in the intervention group ( 1.29 1.56 vs 0.81 1.13 ) , as was the number of residents on 6 or more drugs ( 76.5 % vs. 67.0 % ) , using antipsychotics ( 9.1 % vs 3.2 % ) or duplicate medications ( 32.5 % vs 9.2 % ) .
-RESULTS	The number of fallers increased in the control group ( from 19.3 % to 28 % ) and did not significantly change in the intervention group ( from 25.3 % to 23.9 % ) ; the number of residents with delirium increased in the control group ( from 3.8 % to 9.1 % ) and decreased in the intervention group ( from 6.1 % to 3.2 % ) .
-RESULTS	The number of visits to a physician did not change in the control group ( -0.22 , P = .3 ) but were significantly reduced in the intervention group ( -0.76 , P = .01 ) , the same happened with the number of visits to a nurse ( -0.38 , P = .4 in controls , -1.43 in the intervention group , P < .001 ) .
-RESULTS	Visits to the emergency room and days in hospital significantly increased in the control group ( +0.12 and +0.38 ) but were unchanged in the intervention group ( +0.03 and +0.01 ) .
-CONCLUSIONS	An educational intervention on drug use is feasible in nursing home physicians and improves the use of inappropriate drugs , use of antipsychotics , and drug duplications in their residents .
-CONCLUSIONS	It may also improve the risk of delirium and falls , and reduce the use of health care resources .
-
-###24748530
-OBJECTIVE	This study investigated the isolated and combined effects of heat [ temperate ( 22C/30 % rH ) vs. hot ( 35C/40 % rH ) ] and hypoxia [ sea level ( FiO2 0.21 ) vs. moderate altitude ( FiO2 0.15 ) ] on exercise capacity and neuromuscular fatigue characteristics .
-METHODS	Eleven physically active subjects cycled to exhaustion at constant workload ( 66 % of the power output associated with their maximal oxygen uptake in temperate conditions ) in four different environmental conditions [ temperate/sea level ( control ) , hot/sea level ( hot ) , temperate/moderate altitude ( hypoxia ) and hot/moderate altitude ( hot + hypoxia ) ] .
-METHODS	Torque and electromyography ( EMG ) responses following electrical stimulation of the tibial nerve ( plantar-flexion ; soleus ) were recorded before and 5min after exercise .
-RESULTS	Time to exhaustion was reduced ( P < 0.05 ) in hot ( -3515 % ) or hypoxia ( -3614 % ) compared to control ( 6128min ) , while hot + hypoxia ( -5120 % ) further compromised exercise capacity ( P < 0.05 ) .
-RESULTS	However , the effect of temperature or altitude on end-exercise core temperature ( P = 0.089 and P = 0.070 , respectively ) and rating of perceived exertion ( P > 0.05 ) did not reach significance .
-RESULTS	Maximal voluntary contraction torque , voluntary activation ( twitch interpolation ) and peak twitch torque decreased from pre - to post-exercise ( -91 , -41 and -61 % all trials compounded , respectively ; P < 0.05 ) , with no effect of the temperature or altitude .
-RESULTS	M-wave amplitude and root mean square activity were reduced ( P < 0.05 ) in hot compared to temperate conditions , while normalized maximal EMG activity did not change .
-RESULTS	Altitude had no effect on any measured parameters .
-CONCLUSIONS	Moderate hypoxia in combination with heat stress reduces cycling time to exhaustion without modifying neuromuscular fatigue characteristics .
-CONCLUSIONS	Impaired oxygen delivery or increased cardiovascular strain , increasing relative exercise intensity , may have also contributed to earlier exercise cessation .
-
-###25241755
-OBJECTIVE	To evaluate to what extent a twice daily dose of Transcranial Pulsating ElectroMagnetic Fields ( T-PEMF ) was superior to once daily in patients with treatment-resistant depression as to obtaining symptom remission after 8 weeks of augmentation therapy .
-METHODS	A self-treatment set-up of the T-PEMF device was used allowing self-administration by patients in own homes .
-METHODS	All patients were treated for 30 min per T-PEMF session .
-METHODS	The antidepressant medication the patients were receiving at baseline remained unchanged during the trial .
-METHODS	The patients were randomised to either one T-PEMF dose ( active dose in the morning and sham in the afternoon ) or two T-PEMF doses ( active dose both morning and afternoon ) in a double-blind procedure .
-METHODS	A score of 7 or less on the Hamilton Depression Scale ( HAM-D17 ) was the criterion of remission .
-RESULTS	In total 34 patients received active T-PEMF once a day and 31 patients twice daily .
-RESULTS	After 5 weeks of therapy remission was obtained in 26.5 % and 32.3 % on one dose and two doses of T-PEMF , respectively .
-RESULTS	After 8 weeks the rate of remission was 73.5 % and 67.7 % , respectively .
-RESULTS	The side effects as measured by the Udvalget for Kliniske Undersgelser scale showed a better toleration of the antidepresssive medication in both treatment groups , which was reflected by the WHO-5 well-being scale with increased scores in both groups of patients .
-CONCLUSIONS	The high remission rate obtained by the T-PEMF augmentation was not a dose effect ( one versus two daily T-PEMF sessions ) but was explained by the extension of the treatment period from 5 to 8 weeks .
-
-###24697586
-BACKGROUND	Broadband ultraviolet A ( BB-UVA ) has been successfully used in the treatment of scleroderma , a UVA1-responsive dermatosis .
-OBJECTIVE	To compare the efficacy of BB-UVA versus psoralen + UVA ( PUVA ) in psoriasis treatment and assess apoptosis as an effector mechanism .
-METHODS	This randomized controlled trial included 61 patients with chronic plaque psoriasis randomly divided into group I or II .
-METHODS	Group I were further randomized to either IA or IB who received UVA 10 or 15J/cm ( 2 ) per session , respectively , while group II received PUVA .
-METHODS	Therapy was delivered thrice weekly until clearance or 48 treatments at most .
-METHODS	The primary outcome measured was clearance of psoriasis .
-METHODS	Dermal lymphocytic counts and bcl-2 expression were measured in 20 patients from each group .
-RESULTS	Final Psoriasis Area Severity Index scores were reduced within each group .
-RESULTS	The UVA group achieved results comparable to PUVA until session 24 but failed to match it at final evaluation , with significantly better clinical , immunohistochemical , and histopathological results achieved by PUVA ( P0 .05 ) .
-RESULTS	Both modalities caused a reduction in dermal lymphocytic counts and epidermal bcl-2 expression .
-CONCLUSIONS	BB-UVA appears to be safe and acceptable for the treatment of chronic plaque psoriasis possibly through bcl-2-mediated apoptosis of keratinocytes and epidermal lymphocytes .
-
-###25881035
-BACKGROUND	The public reporting of health outcomes has become one of the most popular topics and is accepted as a quality improvement method in the healthcare field .
-BACKGROUND	However , little research has been conducted on the transparency mechanism , and results are mixed with regard to the evaluation of the effect of public reporting on quality improvement .
-BACKGROUND	The objectives of this trial are to investigate the transparency mechanism and to evaluate the effect of public reporting on prescription at the level of individual participants .
-METHODS	This study involves a cluster randomized controlled trial conducted in 20 primary-care facilities ( clusters ) .
-METHODS	Eligible clusters are those facilities with excellent hospital information systems and that have agreed to participate in the trial .
-METHODS	The 20 clusters are matched into 10 pairs according to Technique for Order Preference by Similarity to Ideal Solution score .
-METHODS	As the unit of randomization , each pair of facilities is assigned at random to a control or an intervention group through coin flipping .
-METHODS	Prescribed ranking information is publicly reported in the intervention group .
-METHODS	The public materials include the posters of individuals and of facilities , the ranking lists of general practitioners , and brochures of patients , which are updated monthly .
-METHODS	The intervention began on 13th November 2013 and lasted for one year .
-METHODS	Specifically , participants are surveyed at five points in time ( baseline , quarterly following the intervention ) through questionnaires , interviews , and observations .
-METHODS	These participants include an average of 600 patients , 300 general practitioners , 15 directors , and 6 health bureau administrators .
-METHODS	The primary outcomes are the transparency mechanism model and the changes in medicine-prescribe .
-METHODS	Subsequently , the modifications in the transparency mechanism constructs are evaluated .
-METHODS	The outcomes are measured at the individual participant level , and the professional who analyzes the data is blind to the randomization status .
-CONCLUSIONS	This study protocol outlines a design that aims to examine the transparency mechanism and to evaluate the effect of public reporting on prescription .
-CONCLUSIONS	The research design is significant in the field of public policy .
-CONCLUSIONS	Furthermore , this study intends to fill the gap of the investigation of the transparency mechanism and the evaluation of public reporting on prescription .
-
-###24874401
-BACKGROUND	New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions .
-BACKGROUND	To address this need , two new skin test antigens were developed to assess safety and efficacy in human trials .
-METHODS	A Phase I safety trial was first conducted in a non-endemic region for leprosy ( U.S.A. ) .
-METHODS	Healthy non-exposed subjects ( n = 10 ) received three titrated doses ( 2.5 g , 1.0 g and 0.1 g ) of MLSA-LAM ( n = 5 ) or MLCwA ( n = 5 ) and control antigens [ Rees MLSA ( 1.0 g ) and saline ] .
-METHODS	A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy ( Nepal ) , but involved only the 1.0 g ( high dose ) and 0.1 g ( low dose ) of each antigen ; Tuberculin PPD served as a control antigen .
-METHODS	This Phase II safety and efficacy trial consisted of three Stages : Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively , and Stage C was then conducted in two parts ( high dose and low dose ) , each enrolling 80 participants : 20 borderline lepromatous/lepromatous ( BL/LL ) leprosy patients , 20 borderline tuberculoid/tuberculoid ( BT/TT ) leprosy patients , 20 household contacts of leprosy patients ( HC ) , and 20 tuberculosis ( TB ) patients .
-METHODS	The primary outcome measure for the skin test was delayed type hypersensitivity induration .
-RESULTS	In the small Phase I safety trial , reactions were primarily against the 2.5 g dose of both antigens and Rees control antigen , which were then excluded from subsequent studies .
-RESULTS	In the Phase II , Stage A/B ramped-up safety study , 26 % of subjects ( 13 of 50 ) showed induration against the high dose of each antigen , and 4 % ( 2 of 50 ) reacted to the low dose of MLSA-LAM .
-RESULTS	Phase II , Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20 % and 25 % in BT/TT leprosy patients , but high specificity at 100 % and 95 % compared to TB patients .
-RESULTS	The high dose of both antigens showed lower specificity ( 70 % and 60 % ) and sensitivity ( 10 % and 15 % ) .
-RESULTS	BL/LL leprosy patients were anergic to the leprosy antigens .
-CONCLUSIONS	MLSA-LAM and MLCwA at both high ( 1.0 g ) and low ( 0.1 g ) doses were found to be safe for use in humans without known exposure to leprosy and in target populations .
-CONCLUSIONS	At a sensitivity rate of 20-25 % these antigens are not suitable as a skin test for the detection of the early stages of leprosy infection ; however , the degree of specificity is impressive given the presence of cross-reactive antigens in these complex native M. leprae preparations .
-BACKGROUND	ClinicalTrails.gov NCT01920750 ( Phase I ) , NCT00128193 ( Phase II ) .
-
-###25041994
-BACKGROUND	Recurrence and toxicity occur commonly among patients with rectal cancer who are treated with 5-fluorouracil ( 5-FU ) .
-BACKGROUND	The authors hypothesized that genetic variation in folate-metabolizing genes could play a role in interindividual variability .
-BACKGROUND	The objective of the current study was to evaluate the associations between genetic variants in folate-metabolizing genes and clinical outcomes among patients with rectal cancer treated with 5-FU .
-METHODS	The authors investigated 8 functionally significant polymorphisms in 6 genes ( methylenetetrahydrofolate reductase [ MTHFR ] [ C677T , A1298C ] , SLC19A1 [ G80A ] , SHMT1 [ C1420T ] , dihydrofolate reductase [ DHFR ] [ Del19bp ] , TS 1494del , and TSER ) involved in folate metabolism in 745 patients with TNM stage II or III rectal cancer enrolled in a phase 3 adjuvant clinical trial of 3 regimens of 5-FU and radiotherapy ( INT-0144 and SWOG 9304 ) .
-RESULTS	There were no statistically significant associations noted between polymorphisms in any of the genes and overall survival , disease-free survival ( DFS ) , and toxicity in the overall analyses .
-RESULTS	Nevertheless , there was a trend toward worse DFS among patients with the variant allele of MTHFR C677T compared with wild-type , particularly in treatment arm 2 , in which patients with the MTHFR C677T TT genotype had worse overall survival ( hazards ratio , 1.76 ; 95 % confidence interval , 1.06-2 .93 [ P = .03 ] ) and DFS ( hazards ratio , 1.84 ; 95 % confidence interval , 1.12-3 .03 [ P = .02 ] ) compared with those with homozygous wild-type .
-RESULTS	In addition , there was a trend toward reduced hematological toxicity among patients with variants of SLC19A1 G80A in treatment arm 1 ( P for trend , .06 ) and reduced esophagitis/stomatitis noted among patients with variants of TSER in treatment arm 3 ( P for trend , .06 ) .
-CONCLUSIONS	Genetic variability in folate-metabolizing enzymes was found to be associated only to a limited degree with clinical outcomes among patients with rectal cancer treated with 5-FU .
-
-###24290404
-BACKGROUND	Pelvic organ prolapse is common and is strongly associated with childbirth and increasing age .
-BACKGROUND	Women with prolapse are often advised to do pelvic floor muscle exercises , but evidence supporting the benefits of such exercises is scarce .
-BACKGROUND	We aimed to establish the effectiveness of one-to-one individualised pelvic floor muscle training for reducing prolapse symptoms .
-METHODS	We did a parallel-group , multicentre , randomised controlled trial at 23 centres in the UK , one in New Zealand , and one in Australia , between June 22 , 2007 , and April 9 , 2010 .
-METHODS	Female outpatients with newly-diagnosed , symptomatic stage I , II , or III prolapse were randomly assigned ( 1:1 ) , by remote computer allocation with minimsation , to receive an individualised programme of pelvic floor muscle training or a prolapse lifestyle advice leaflet and no muscle training ( control group ) .
-METHODS	Outcome assessors , and investigators who were gynaecologists at trial sites , were masked to group allocation ; the statistician was masked until after data analysis .
-METHODS	Our primary endpoint was participants ' self-report of prolapse symptoms at 12 months .
-METHODS	Analysis was by intention-to-treat analysis .
-METHODS	This trial is registered , number ISRCTN35911035 .
-RESULTS	447 eligible patients were randomised to the intervention group ( n = 225 ) or the control group ( n = 222 ) .
-RESULTS	377 ( 84 % ) participants completed follow-up for questionnaires at 6 months and 295 ( 66 % ) for questionnaires at 12 months .
-RESULTS	Women in the intervention group reported fewer prolapse symptoms ( ie , a significantly greater reduction in the pelvic organ prolapse symptom score [ POP-SS ] ) at 12 months than those in the control group ( mean reduction in POP-SS from baseline 3.77 [ SD 5.62 ] vs 2.09 [ 5.39 ] ; adjusted difference 1.52 , 95 % CI 0.46-2 .59 ; p = 0.0053 ) .
-RESULTS	Findings were robust to missing data .
-RESULTS	Eight adverse events ( six vaginal symptoms , one case of back pain , and one case of abdominal pain ) and one unexpected serious adverse event , all in women from the intervention group , were regarded as unrelated to the intervention or to participation in the study .
-CONCLUSIONS	One-to-one pelvic floor muscle training for prolapse is effective for improvement of prolapse symptoms .
-CONCLUSIONS	Long-term benefits should be investigated , as should the effects in specific subgroups .
-BACKGROUND	Chief Scientist Office of the Scottish Government Health and Social Care Directorates , New Zealand Lottery Board , and National Health and Medical Research Council ( Australia ) .
-
-###25125229
-BACKGROUND	To compare the efficacy of the Newcastle infant dialysis and ultrafiltration system ( Nidus ) with peritoneal dialysis ( PD ) and conventional haemodialysis ( HD ) in infants weighing < 8 kg .
-METHODS	We compared the urea , creatinine and phosphate clearances , the ultrafiltration precision , and the safety of the Nidus machine with PD in 7 piglets weighing 1-8 kg , in a planned randomised cross-over trial in babies , and in babies for whom no other therapy existed , some of whom later graduated to conventional HD .
-RESULTS	Two babies entered the randomised trial ; 1 recovered rapidly on PD , the other remained on the Nidus as PD failed .
-RESULTS	Additionally , 9 babies were treated on the Nidus on humanitarian grounds : 3 because of failed PD , and 3 with permanent kidney failure later converted to conventional HD .
-RESULTS	We haemodialysed 10 babies weighing between 1.8 and 5.9 kg for 2,475 h during 354 Nidus sessions without any clinically important incidents , and without detectable haemolysis .
-RESULTS	Single-lumen vascular access was used with no blood priming of circuits .
-RESULTS	The urea , creatinine and phosphate clearances using the Nidus were around 1.5 to 2.0 ml/min in piglets and babies , and were consistently higher than PD clearances , which ranged from about 0.2 to 0.8 ml/min ( p0 .0002 for each chemical ) .
-RESULTS	Ultrafiltration was achieved to microlitre precision by the Nidus , but varied widely with PD .
-RESULTS	Fluid removal using conventional HD was imprecise and resulted in some hypovolaemic episodes requiring correction .
-CONCLUSIONS	The Nidus can provide HD in the Pediatric Intensive Care Unit ( PICU ) and outpatient intermittent HD without blood priming for babies weighing < 8 kg , It generates higher dialysis clearances than PD , and delivers more precise ultrafiltration control than either PD or conventional HD .
-
-###24939043
-OBJECTIVE	To evaluate the effects of canagliflozin on plasma volume , urinary glucose excretion ( UGE ) , fasting plasma glucose ( FPG ) , glycated haemoglobin ( HbA1c ) and additional measures of fluid/electrolyte balance in patients with type 2 diabetes on background therapy with metformin and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers .
-METHODS	Patients ( N = 36 ) were randomized ( 1:1 ) to receive canagliflozin 300 mg or placebo for 12 weeks .
-METHODS	Pharmacodynamic parameters were assessed at baseline and at weeks 1 and 12 .
-RESULTS	Increased 24-h UGE was seen in the canagliflozin group compared with a reduction in the placebo group at both week 1 ( 91.8 vs. -2.4 g ) and week 12 ( 82.6 vs. -0.4 g ) .
-RESULTS	Canagliflozin also reduced both FPG and HbA1c .
-RESULTS	Reductions in body weight and blood pressure were observed at weeks 1 and 12 .
-RESULTS	Canagliflozin decreased plasma volume compared with an increase with placebo at week 1 ( -5.4 vs. 4.3 % ; p = 0.02 ) , but this was largely attenuated at week 12 ( 4.6 vs. 5.8 % ; p = 0.76 ) .
-RESULTS	A modest numerical increase in urine volume was observed with canagliflozin at week 1 that was attenuated at week 12 ; other measures of volume status ( i.e. blood urea nitrogen , serum creatinine and haematocrit ) remained modestly increased with canagliflozin at week 12 .
-CONCLUSIONS	Canagliflozin provided sustained effects on UGE and FPG over 12 weeks and a transient reduction in plasma volume that was largely attenuated by week 12 .
-
-###26244877
-BACKGROUND	Androgen-deprivation therapy ( ADT ) has been the backbone of treatment for metastatic prostate cancer since the 1940s .
-BACKGROUND	We assessed whether concomitant treatment with ADT plus docetaxel would result in longer overall survival than that with ADT alone .
-METHODS	We assigned men with metastatic , hormone-sensitive prostate cancer to receive either ADT plus docetaxel ( at a dose of 75 mg per square meter of body-surface area every 3 weeks for six cycles ) or ADT alone .
-METHODS	The primary objective was to test the hypothesis that the median overall survival would be 33.3 % longer among patients receiving docetaxel added to ADT early during therapy than among patients receiving ADT alone .
-RESULTS	A total of 790 patients ( median age , 63 years ) underwent randomization .
-RESULTS	After a median follow-up of 28.9 months , the median overall survival was 13.6 months longer with ADT plus docetaxel ( combination therapy ) than with ADT alone ( 57.6 months vs. 44.0 months ; hazard ratio for death in the combination group , 0.61 ; 95 % confidence interval [ CI ] , 0.47 to 0.80 ; P < 0.001 ) .
-RESULTS	The median time to biochemical , symptomatic , or radiographic progression was 20.2 months in the combination group , as compared with 11.7 months in the ADT-alone group ( hazard ratio , 0.61 ; 95 % CI , 0.51 to 0.72 ; P < 0.001 ) .
-RESULTS	The rate of a prostate-specific antigen level of less than 0.2 ng per milliliter at 12 months was 27.7 % in the combination group versus 16.8 % in the ADT-alone group ( P < 0.001 ) .
-RESULTS	In the combination group , the rate of grade 3 or 4 febrile neutropenia was 6.2 % , the rate of grade 3 or 4 infection with neutropenia was 2.3 % , and the rate of grade 3 sensory neuropathy and of grade 3 motor neuropathy was 0.5 % .
-CONCLUSIONS	Six cycles of docetaxel at the beginning of ADT for metastatic prostate cancer resulted in significantly longer overall survival than that with ADT alone .
-CONCLUSIONS	( Funded by the National Cancer Institute and others ; ClinicalTrials.gov number , NCT00309985 . )
-
-###24255129
-OBJECTIVE	The aim of this study was to evaluate the haemodynamic effects of serelaxin ( 30 g/kg/day 20-h infusion and 4-h post-infusion period ) in patients with acute heart failure ( AHF ) .
-RESULTS	This double-blind , multicentre study randomized 71 AHF patients with pulmonary capillary wedge pressure ( PCWP ) 18 mmHg , systolic blood pressure ( BP ) 115 mmHg , and estimated glomerular filtration rate 30 mL/min/1 .73 m ( 2 ) to serelaxin ( n = 34 ) or placebo ( n = 37 ) within 48 h of hospitalization .
-RESULTS	Co-primary endpoints were peak change from baseline in PCWP and cardiac index ( CI ) during the first 8 h of infusion .
-RESULTS	Among 63 patients eligible for haemodynamic analysis ( serelaxin , n = 32 ; placebo , n = 31 ) , those treated with serelaxin had a significantly higher decrease in peak PCWP during the first 8 h of infusion ( difference vs. placebo : -2.44 mmHg , P = 0.004 ) .
-RESULTS	Serelaxin showed no significant effect on the peak change in CI vs. placebo .
-RESULTS	Among secondary haemodynamic endpoints , a highly significant reduction in pulmonary artery pressure ( PAP ) was observed throughout the serelaxin infusion ( largest difference in mean PAP vs. placebo : -5.17 mmHg at 4 h , P < 0.0001 ) .
-RESULTS	Right atrial pressure , systemic/pulmonary vascular resistance , and systolic/diastolic BP decreased from baseline with serelaxin vs. placebo and treatment differences reached statistical significance at some time points .
-RESULTS	Serelaxin administration improved renal function and decreased N-terminal pro-brain natriuretic peptide levels vs. placebo .
-RESULTS	Treatment with serelaxin was well tolerated with no apparent safety concerns .
-CONCLUSIONS	The haemodynamic effects of serelaxin observed in the present study provide plausible mechanistic support for improvement in signs and symptoms of congestion observed with this agent in AHF patients .
-CONCLUSIONS	ClinicalTrials.gov identifier NCT01543854 .
-
-###24956042
-OBJECTIVE	Quetiapine is an atypical antipsychotic with demonstrated efficacy in the treatment of adolescent schizophrenia and pediatric bipolar mania .
-OBJECTIVE	Large , placebo-controlled studies of interventions in pediatric bipolar depression are lacking .
-OBJECTIVE	The current study investigated the efficacy and safety of quetiapine extended-release ( XR ) in patients 10-17 years of age , with acute bipolar depression .
-METHODS	This multicenter , double-blind , randomized , placebo-controlled study investigated quetiapine XR ( dose range , 150-300mg / day ) in pediatric outpatients with an American Psychiatric Association , Diagnostic and Statistical Manual of Mental Disorders , 4th ed. , Text Revision ( DSM-IV-TR ) diagnosis of bipolar I or bipolar II disorder ( current or most recent episode depressed ) treated for up to 8 weeks ( ClinicalTrials.gov identifier : NCT00811473 ) .
-METHODS	The primary study outcome was mean change in Children 's Depression Rating Scale-Revised ( CDRS-R ) total score .
-METHODS	Secondary efficacy outcomes included CDRS-R-based response and remission rates .
-RESULTS	Of 193 patients randomized to treatment , 144 patients completed the study ( 75.3 % of quetiapine XR group [ n = 70 ] ; 74.0 % of placebo group [ n = 74 ] ) .
-RESULTS	Least squares mean changes in CDRS-R total score at week 8 were : -29.6 ( SE , 1.65 ) with quetiapine XR and -27.3 ( SE , 1.60 ) with placebo , a between-treatment group difference of -2.29 ( SE , 1.99 ; 95 % CI , -6.22 , 1.65 ; p = 0.25 ; mixed-model for repeated measures analysis ) .
-RESULTS	Rates of response and remission did not differ significantly between treatment groups .
-RESULTS	The safety profile of quetiapine XR was broadly consistent with the profile reported previously in adult studies of quetiapine XR and pediatric studies of quetiapine immediate-release ( IR ) .
-RESULTS	Potentially clinically significant elevations in clinical chemistry values included triglycerides ( 9.3 % , quetiapine XR ; 1.4 % , placebo group ) and thyroid stimulating hormone ( 4.7 % , quetiapine XR ; 0 % , placebo group ) .
-RESULTS	An adverse event potentially related to diabetes mellitus occurred in 3.3 % of the quetiapine XR versus no adverse events in the placebo group .
-CONCLUSIONS	Quetiapine XR did not demonstrate efficacy relative to placebo in this 8 week study of pediatric bipolar depression .
-CONCLUSIONS	Quetiapine XR was generally safe and well tolerated .
-
-###24332142
-BACKGROUND	Patients who adhere to medications experience better outcomes than their nonadherent counterparts .
-BACKGROUND	However , these observations may be confounded by patient behaviors .
-BACKGROUND	The level of adherence necessary for patients to derive benefit and whether adherence to all agents is important for diseases that require multiple drugs remain unclear .
-BACKGROUND	This study quantifies the relationship between medication adherence and post-myocardial infarction ( MI ) adverse coronary events .
-METHODS	This is a secondary analysis of the randomized MI FREEE trial .
-METHODS	Patients who received full prescription coverage were classified as adherent ( proportion of days covered 80 % ) or not based upon achieved adherence in the 6 months after randomization .
-METHODS	First major vascular event or revascularization rates were compared using multivariable Cox models adjusting for comorbidity and health-seeking behavior .
-RESULTS	Compared with patients randomized to usual care , full coverage patients adherent to statin , - blocker , or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker were significantly less likely to experience the study 's primary outcome ( hazard ratio [ HR ] range 0.64-0 .81 ) .
-RESULTS	In contrast , nonadherent patients derived no benefit ( HR range 0.98-1 .04 , P .01 for the difference in HRs between adherent and nonadherent patients ) .
-RESULTS	Partially adherent patients had no reduction in clinical outcomes for any of the drugs evaluated , although their achieved adherence was higher than that among controls .
-CONCLUSIONS	Achieving high levels of adherence to each and all guideline-recommended post-MI secondary prevention medication is associated with improved event-free survival .
-CONCLUSIONS	Lower levels of adherence appear less protective .
-
-###25439413
-OBJECTIVE	To evaluate whether ramosetron increases the corrected QT ( QTc ) interval .
-METHODS	Prospective , randomized , controlled study .
-METHODS	Operating room .
-METHODS	135 patients undergoing elective laparoscopic cholecystectomy .
-METHODS	Patients were allocated to three groups to receive ondansetron 4 mg ( Group O4 ) , ramosetron 0.3 mg ( Group R ) , or ondansetron 8 mg ( Group O8 ) .
-METHODS	The study drugs were administered intravenously approximately 15 minutes before the end of surgery .
-METHODS	The QT interval for 10 minutes after administration was recorded .
-METHODS	The QTc interval was calculated according to the Fridericia ( QTcF ) formula .
-METHODS	The primary outcome was the QTcF interval among the three groups during the 10 minutes after administration of the study drugs .
-RESULTS	The QTcF interval was not significantly prolonged after administration of ondansetron 4 mg and ramosetron .
-RESULTS	It was significantly increased from one minute after administration until 7 minutes after ondansetron 8 mg ( Group O8 ) .
-RESULTS	The QTcF interval was significantly longer in Group O8 at 1 , 2 , 3 , 4 , and 5 minutes .
-CONCLUSIONS	The prophylactic administration 0.3 mg of ramosetron does not increase the QTc interval .
-CONCLUSIONS	Ondansetron 8 mg increases the QTc interval more so than 4 mg of ondansetron .
-
-###25197740
-OBJECTIVE	To determine whether mechanical cleaning with interdental brushes combined with the use of cetylpyridinium chloride ( 0.3 % CPC ) gel was more effective at plaque control than mechanical cleaning with interdental brushes alone .
-METHODS	Forty individuals ( 30-70 years old ) with at least 20 teeth and moderate chronic periodontitis who had no experience with interdental cleaning aids were randomly assigned to a treatment group ( brush + gel , n = 20 ) or a control group ( brush , n = 20 ) .
-METHODS	Both groups were examined by a dentist at baseline and at 3 and 6 months for changes in interdental plaque ( interproximal plaque index [ API ] ) levels , gingival inflammation ( sulcus bleeding index [ SBI ] ) , probing depth ( PD ) and bleeding on probing ( BOP ) .
-RESULTS	No baseline differences in age , gender or number of teeth were observed between the two groups .
-RESULTS	During the study period , improvements in API and BOP were comparable between groups .
-RESULTS	However , improvements in SBI and PD were significantly greater in the test group than in the control group ( p = 0.046 and p = 0.029 , respectively ) .
-CONCLUSIONS	Mechanical interdental plaque control using interdental brushes combined with the use of CPC gel significantly improved 6-month gingival and periodontal outcomes ( SBI and PD ) compared with mechanical cleaning with interdental brushes alone .
-
-###24408214
-BACKGROUND	Nicotine patches have been reliably demonstrated to improve smoking cessation outcomes but most users still lapse , and then relapse , during treatment .
-BACKGROUND	While patch has been shown to alleviate background cravings , its effects on cue-induced cravings - which have been linked to the occurrence of lapse events - are poorly understood .
-OBJECTIVE	Here we investigate the effect of nicotine patch on the intensity of craving and negative affect experienced during the hours immediately preceding lapse episodes .
-METHODS	Participants were 185 smokers who had quit in the context of a randomized , double-blind trial of high-dose ( 35mg ) nicotine patch and who lapsed at least once during the first 5 weeks of treatment .
-METHODS	Participants used electronic diaries to monitor their smoking , affect , and craving during their cessation attempt .
-CONCLUSIONS	The data suggest that developments on the lapse day - either external events or changes in internal states - caused craving and negative affect to rise , cumulating in the lapse .
-CONCLUSIONS	Nicotine is known to lower background craving and negative affect , but the difference between patch and placebo appeared to dissipate in the hours immediately preceding lapse episodes .
-CONCLUSIONS	Understanding the process by which these symptoms `` spike '' prior to a lapse - and developing treatments to counter it - are worthy research endeavors .
-
-###24740312
-OBJECTIVE	This randomized double-blind study was designed to determine if respiratory muscle weakness - measured by maximum inspiratory pressure ( MIP ) , maximum expiratory pressure ( MEP ) , forced vital capacity ( FVC ) , and forced expiratory volume in one second ( FEV1 ) - persists even if an acceleromyographic train-of-four ratio ( TOFR ) of 1.0 is reached after major abdominal surgery .
-METHODS	Twenty patients underwent respiratory function tests before induction of anesthesia .
-METHODS	Rocuronium was given , and the tests were repeated after extubation when the TOFR reached 1.0 .
-METHODS	The patients were then randomized to receive sugammadex 1 mgkg ( -1 ) or placebo , and the same tests were repeated five and 20 min later .
-METHODS	Between-group comparisons were carried out with a mixed-model analysis of variance analysis .
-RESULTS	After anesthesia and adequate epidural analgesia , MIP and MEP decreased by 60 % in both groups .
-RESULTS	In the placebo group , MIP decreased from a pre-induction value ( median [ range ] ) of 61.8 [ 31.3-96 .1 ] to 19.6 [ 8.3-58 .3 ] cm H2O after extubation without significant variation five and 20 min after placebo .
-RESULTS	In the sugammadex group , MIP decreased from a pre-induction value of 57.8 [ 13.0-96 .4 ] to 20.5 [ 6.4-67 .3 ] cm H2O after extubation .
-RESULTS	No differences were recorded after sugammadex administration ( P = 0.246 between groups ) .
-RESULTS	In the placebo group , MEP decreased from 88.8 [ 65.1-120 .3 ] before induction to 37.6 [ 13.4-70 .6 ] cm H2O after extubation .
-RESULTS	In the sugammadex group , MEP decreased from 85.5 [ 58.6-132 .7 ] to 30.8 [ 10.5-60 .5 ] cm H2O , with no improvement five and 20 min after either placebo or sugammadex administration ( P = 0.648 ) .
-RESULTS	Similarly , the FCV and FEV1 decreased 30-40 % after extubation in both study groups .
-CONCLUSIONS	Acceleromyographic TOFR of 1.0 excludes residual neuromuscular paralysis .
-CONCLUSIONS	However , major respiratory dysfunction is observed after abdominal surgery .
-CONCLUSIONS	This trial was registered at ClinicalTrials.gov : NCT01503840 .
-
-###25730227
-OBJECTIVE	To compare the rates of neonatal morbidity and cerebral palsy among preterm neonates ( less than 37 weeks of gestation ) delivered by cesarean for a nonreassuring fetal heart rate ( FHR ) tracing compared with those who did not .
-METHODS	This was a secondary analysis of a multicenter randomized trial of MgSO4 for the prevention of cerebral palsy .
-METHODS	Newborns of women delivered by cesarean delivery for nonreassuring FHR were compared with a control group composed of the offspring of women who labored for 2 hours or longer but did not undergo cesarean delivery for nonreassuring FHR regardless of the mode of delivery .
-METHODS	Using multivariable analysis to adjust for potential confounders , our objective was to compare two outcomes : 1 ) composite neonatal morbidity ( Apgar score 3 or less at 5 minutes , seizure , sepsis , necrotizing enterocolitis grade II or III , intraventricular hemorrhage grade III or IV , or death before discharge ) and 2 ) neurologic injury ( cerebral palsy ) at 2 years or more of corrected age between the groups .
-RESULTS	Of the 1,291 preterm neonates who met the inclusion criteria , 177 ( 14 % ) were delivered by cesarean for nonreassuring FHR compared with 1,114 ( 86 % ) in the control group .
-RESULTS	Composite neonatal morbidity was similar between the groups ( 30.5 compared with 22.2 % , adjusted odds ratio [ OR ] 1.4 , 95 % confidence interval [ CI ] 0.9-2 .1 ) .
-RESULTS	The rate of cerebral palsy of any severity ( 8.3 compared with 4.0 % , adjusted OR 2.3 , 95 % CI 1.2-4 .5 ) and moderate-to-severe cerebral palsy at 2 years of corrected age ( 6.0 compared with 2.2 % , adjusted OR 3.2 , 95 % CI 1.4-7 .1 ) was significantly higher in children born through cesarean delivery for nonreassuring FHR .
-CONCLUSIONS	Nonreassuring fetal tracing deemed so serious as to require cesarean delivery is associated with an increased risk of cerebral palsy in preterm neonates .
-METHODS	II .
-
-###25381314
-BACKGROUND	Concerns that general health checks , including screening for risk factors to ischemic heart disease ( IHD ) , have negative psychological consequences seem widely unfounded ; however , previous studies are only based on self-reports from participants .
-OBJECTIVE	To investigate if risk factor screening in healthy adults leads to mental distress in the study population , independent of participation .
-METHODS	The Inter99 study ( 1999 - 2006 ) was a randomised intervention in the general population , aiming to prevent IHD by a healthier lifestyle .
-METHODS	We included the whole study population , independent of participation ( n = 60,915 ) .
-METHODS	We merged data with information on the use of psychotropic medication and/or hospitalisation due to psychiatric diagnoses , as retrieved from national registers in Denmark , 4 years before and 5 years after the study began .
-METHODS	We conducted analyses using generalised estimating equations .
-RESULTS	There was no significant difference between the intervention and control groups in their use of antipsychotics , hypnotics/sedatives , antidepressants or anxiolytics .
-RESULTS	As regards admission to the hospital with mental disorders , no significant difference was seen .
-RESULTS	These findings were true based on a yearly basis , and when investigating both short-term and a long-term effects of the intervention .
-RESULTS	There was no interaction with socioeconomic status .
-RESULTS	Of the 918 persons with a psychiatric diagnosis before the study start , 303 ( 33 % ) were re-admitted in the intervention period .
-RESULTS	Pre-screening of psychological status did not influence the psychological impact of screening .
-CONCLUSIONS	This large , randomised intervention study supports that screening for risk factors to IHD does not increase mental distress , not even in the mentally or socioeconomically most vulnerable persons .
-CONCLUSIONS	This study included the whole Inter99 study population not only study participants .
-
-###25146918
-BACKGROUND	Postoperative pain is an important adverse event following inguinal hernia repair .
-BACKGROUND	The aim of this trial was to compare postoperative pain within the first 3 months and 1 year after surgery in patients undergoing open mesh inguinal hernia repair using either a self-gripping lightweight polyester mesh or a polypropylene lightweight mesh fixed with sutures .
-METHODS	Adult men undergoing Lichtenstein repair for primary inguinal hernia were randomized to ProGrip self-gripping mesh or standard sutured lightweight polypropylene mesh .
-RESULTS	In total 557 men were included in the final analysis ( self-gripping mesh 270 , sutured mesh 287 ) .
-RESULTS	Early postoperative pain scores were lower with self-gripping mesh than with sutured lightweight mesh : mean visual analogue pain score relative to baseline +13 and +86 respectively at discharge ( P = 0033 ) , and mean surgical pain scale score relative to baseline +42 and +97 respectively on day 7 ( P = 0027 ) .
-RESULTS	There was no significant difference in mid-term ( 1month ) and long-term ( 3months and 1 year ) pain scores between the groups .
-RESULTS	Surgery was significantly quicker with self-gripping mesh ( mean difference 76min ; P < 0001 ) .
-RESULTS	There were no significant differences in reported mesh handling , analgesic consumption , other wound complications , patient satisfaction or hernia recurrence between the groups .
-CONCLUSIONS	Self-gripping mesh for open inguinal hernia repair was well tolerated and reduced early postoperative pain ( within the first week ) , without increasing the risk of early recurrence .
-CONCLUSIONS	It did not reduce chronic pain .
-BACKGROUND	NCT00827944 ( http://www.clinicaltrials.gov ) .
-
-###24239341
-OBJECTIVE	Older adults are frequently hospitalized from the emergency department ( ED ) after an episode of unexplained syncope .
-OBJECTIVE	Current admission patterns are costly , with little evidence of benefit .
-OBJECTIVE	We hypothesize that an ED observation syncope protocol will reduce resource use without adversely affecting patient-oriented outcomes .
-METHODS	This randomized trial at 5 EDs compared an ED observation syncope protocol to inpatient admission for intermediate-risk adults ( 50 years ) presenting with syncope or near syncope .
-METHODS	Primary outcomes included inpatient admission rate and length of stay .
-METHODS	Secondary outcomes included 30-day and 6-month serious outcomes after hospital discharge , index and 30-day hospital costs , 30-day quality-of-life scores , and 30-day patient satisfaction .
-RESULTS	Study staff randomized 124 patients .
-RESULTS	Observation resulted in a lower inpatient admission rate ( 15 % versus 92 % ; 95 % confidence interval [ CI ] difference -88 % to -66 % ) and shorter hospital length of stay ( 29 versus 47 hours ; 95 % CI difference -28 to -8 ) .
-RESULTS	Serious outcome rates after hospital discharge were similar for observation versus admission at 30 days ( 3 % versus 0 % ; 95 % CI difference -1 % to 8 % ) and 6 months ( 8 % versus 10 % ; 95 % CI difference -13 % to 9 % ) .
-RESULTS	Index hospital costs in the observation group were $ 629 ( 95 % CI difference - $ 1,376 to - $ 56 ) lower than in the admission group .
-RESULTS	There were no differences in 30-day quality-of-life scores or in patient satisfaction .
-CONCLUSIONS	An ED observation syncope protocol reduced the primary outcomes of admission rate and hospital length of stay .
-CONCLUSIONS	Analyses of secondary outcomes suggest reduction in index hospital costs , with no difference in safety events , quality of life , or patient satisfaction .
-CONCLUSIONS	Our findings suggest that an ED observation syncope protocol can be replicated and safely reduce resource use .
-
-###24678955
-BACKGROUND	Elevated lipoprotein-associated phospholipase A2 activity promotes the development of vulnerable atherosclerotic plaques , and elevated plasma levels of this enzyme are associated with an increased risk of coronary events .
-BACKGROUND	Darapladib is a selective oral inhibitor of lipoprotein-associated phospholipase A2 .
-METHODS	In a double-blind trial , we randomly assigned 15,828 patients with stable coronary heart disease to receive either once-daily darapladib ( at a dose of 160 mg ) or placebo .
-METHODS	The primary end point was a composite of cardiovascular death , myocardial infarction , or stroke .
-METHODS	Secondary end points included the components of the primary end point as well as major coronary events ( death from coronary heart disease , myocardial infarction , or urgent coronary revascularization for myocardial ischemia ) and total coronary events ( death from coronary heart disease , myocardial infarction , hospitalization for unstable angina , or any coronary revascularization ) .
-RESULTS	During a median follow-up period of 3.7 years , the primary end point occurred in 769 of 7924 patients ( 9.7 % ) in the darapladib group and 819 of 7904 patients ( 10.4 % ) in the placebo group ( hazard ratio in the darapladib group , 0.94 ; 95 % confidence interval [ CI ] , 0.85 to 1.03 ; P = 0.20 ) .
-RESULTS	There were also no significant between-group differences in the rates of the individual components of the primary end point or in all-cause mortality .
-RESULTS	Darapladib , as compared with placebo , reduced the rate of major coronary events ( 9.3 % vs. 10.3 % ; hazard ratio , 0.90 ; 95 % CI , 0.82 to 1.00 ; P = 0.045 ) and total coronary events ( 14.6 % vs. 16.1 % ; hazard ratio , 0.91 ; 95 % CI , 0.84 to 0.98 ; P = 0.02 ) .
-CONCLUSIONS	In patients with stable coronary heart disease , darapladib did not significantly reduce the risk of the primary composite end point of cardiovascular death , myocardial infarction , or stroke .
-CONCLUSIONS	( Funded by GlaxoSmithKline ; STABILITY ClinicalTrials.gov number , NCT00799903 . )
-
-###24355040
-BACKGROUND	The association between testosterone deficiency and insulin resistance in men with type 2 diabetes is well established .
-BACKGROUND	Current Endocrine Society and European Association of Urology guidelines recommend the measurement of testosterone levels in all men with type 2 diabetes and in men suffering from erectile dysfunction .
-BACKGROUND	It is recognised that a range of physical symptoms appear as the testosterone level falls but few studies have addressed the threshold at which symptoms improve with physiological replacement .
-BACKGROUND	We report the first double-blind placebo-controlled study conducted exclusively in a male type 2 diabetes population to assess the metabolic changes with testosterone replacement .
-METHODS	The type 2 diabetes registers of seven general practices were screened to establish the prevalence of low testosterone and the associations with diabetes control .
-METHODS	Of 550 eligible patients approached , 488 men ( mean age 62.6 ) consented to take part in screening with a morning testosterone level , assessed between 8 and 11 am .
-METHODS	This identified 211 patients for a double-blind placebo-controlled study of long acting testosterone undecanoate ( TU ) 1000 mg lasting 30 weeks followed by 52 weeks of open label use .
-METHODS	The population was divided into a SEVERE group with either total testosterone ( TT ) of 8 nmol/l or less or free testosterone ( FT ) 180 pmol/l or less or a MILD group with TT 8.1-12 nmol/l or FT 181-250 pmol/l .
-RESULTS	Men in the SEVERE group increased mean through TT from 7.73 nmol/l at baseline to 9.93 at 30 weeks and the MILD group from 10.47 to 11.94 .
-RESULTS	The SEVERE group showed marked improvement in sexual function , but no significant improvement in metabolic parameters .
-RESULTS	The MILD group showed no improvement in sexual function , but significant improvement in weight , body mass index , waist circumference and Hospital Anxiety and Depression Scale .
-RESULTS	Improvement was seen in all parameters during 52 weeks open label treatment where trough TT levels approached 15 nmol/l .
-RESULTS	Baseline prostate-specific antigen ( PSA ) was lower in the SEVERE group and increased with TU for 30 weeks and then stabilised .
-RESULTS	There was no increase in PSA with treatment in the MILD group .
-CONCLUSIONS	Testosterone undecanoate significantly improves sexual parameters and Ageing Male Symptom Score , but not metabolic factors at 30 weeks in men with SEVERE testosterone deficiency syndrome ( TDS ) .
-CONCLUSIONS	In men with MILD TDS , significant improvements in metabolic but not sexual parameters were seen , suggesting that there are threshold levels for response to testosterone replacement therapy and that trials of therapy need to achieve sustained therapeutic levels to be effective .
-CONCLUSIONS	PSA showed minor rises , but only for 30 weeks in the SEVERE group .
-
-###24450370
-METHODS	Randomized controlled trial .
-METHODS	Objectives To examine the efficacy of exercise intervention in patients with knee osteoarthritis ( OA ) , as directed by Mechanical Diagnosis and Therapy ( MDT ) assessment , and , secondarily , to explore outcomes between MDT assessment-defined subgroups within the exercise group .
-BACKGROUND	Due to the high physical and economic burden of knee OA , the effectiveness of conservative interventions and determining those patients who will respond to them should be investigated .
-METHODS	Patients with knee OA ( n = 180 ) were randomized to an exercise intervention group or a control group .
-METHODS	The intervention group , in which patients classified as having knee derangements ( MDT derangement ) received MDT directional exercises and patients classified as nonresponders ( MDT nonresponders ) received evidence-based exercises , was compared to a control group that received no exercise intervention .
-METHODS	Pain and function were assessed at baseline , 2 weeks , and 3 months , using the P4 pain scale and Knee injury and Osteoarthritis Outcome Score ( KOOS ) pain and function subscales .
-METHODS	Two-way analysis of covariance was used to examine treatment and time effects .
-METHODS	Multiple comparisons were examined , and mean differences with 95 % confidence intervals ( CIs ) were reported .
-RESULTS	The exercise intervention group had significantly improved P4 scores ( mean difference , -6 ; 95 % CI : -8 , -3 ) , KOOS pain scores ( mean difference , 9 ; 95 % CI : 5 , 13 ) , and KOOS function scores ( mean difference , 11 ; 95 % CI : 7 , 15 ) compared to those of the control group at 2 weeks .
-RESULTS	At 3 months , the exercise intervention group had significantly improved KOOS pain scores ( mean difference , 7 ; 95 % CI : 3 , 11 ) and KOOS function scores ( mean difference , 5 ; 95 % CI : 1 , 9 ) compared to controls .
-CONCLUSIONS	Patients with knee OA who were prescribed exercises based on an MDT assessment had superior outcomes compared to those of wait-list controls .
-CONCLUSIONS	The MDT subgroup of knee derangement may warrant further investigation in patients with knee OA .
-CONCLUSIONS	Protocol registered at ClinicalTrials.gov ( NCT01641874 ) .
-METHODS	Therapy , level 1b - .
-
-###25304996
-BACKGROUND	Inappropriate use and overuse of antibiotics is a serious concern in the treatment of upper respiratory tract infections ( URTIs ) , especially in developing countries .
-BACKGROUND	In recent decades , information disclosure and public reporting ( PR ) has become an instrument for encouraging good practice in healthcare .
-BACKGROUND	This study evaluated the impact of PR on antibiotic prescribing for URTIs in a sample of primary care institutions in China .
-METHODS	A matched-pair cluster-randomized trial was undertaken in QJ city , with 20 primary care institutions participating in the trial .
-METHODS	Participating institutions were matched into pairs before being randomly assigned into a control and an intervention group .
-METHODS	Prescription statistics were disclosed to patients , health authorities , and health workers monthly within the intervention group , starting from October 2013 .
-METHODS	Outpatient prescriptions for URTIs were collected from both groups before ( 1st March to 31st May , 2013 ) and after the intervention ( 1st March to 31st May , 2014 ) .
-METHODS	A total of 34,815 URTI prescriptions were included in a difference-in-difference analysis using multivariate linear or logistic regression models , controlling for patient attributes as well as institutional characteristics .
-RESULTS	Overall , 90 % URTI prescriptions required antibiotics and 21 % required combined use of antibiotics .
-RESULTS	More than 77 % of URTI prescriptions required intravenous ( IV ) injection or infusion of drugs .
-RESULTS	PR resulted in a 9 percentage point ( 95 % CI -17 to -1 ) reduction in the use of oral antibiotics ( adjusted RR = 39 % , P = 0.027 ) , while the use of injectable antibiotics remained unchanged .
-RESULTS	PR led to a 7 percentage point reduction ( 95 % CI -14 to 0 ; adjusted RR = 36 % ) in combined use of antibiotics ( P = 0.049 ) , which was largely driven by a significant reduction in male patients ( -7.5 % , 95 % CI -14 to -1 , P = 0.03 ) .
-RESULTS	The intervention had little impact on the use of IV injections or infusions , or the total prescription expenditure .
-CONCLUSIONS	The results suggest that PR could improve prescribing practices in terms of reducing oral antibiotics and combined use of antibiotics ; however , the impacts were limited .
-CONCLUSIONS	We suggest that PR would probably be enhanced by provider payment reform , management and training for providers , and health education for patients .
-
-###25470476
-OBJECTIVE	The aim of this study was to evaluate the effects of guided imagery as a nursing intervention for pain management and depression in patients diagnosed with fibromyalgia .
-BACKGROUND	Many studies support the use of guided imagery to improve patient outcomes .
-BACKGROUND	Guided imagery has been used for different purposes and it is thought to be an effective intervention for people suffering from nonmalignant pain .
-METHODS	A 2-group quasi-experimental study was conducted during 8 weeks by the University of Nursing in Almeria ( Spain ) .
-METHODS	Patients diagnosed with fibromyalgia aged 18 to 70 years ( n = 60 ) were randomly assigned to a guided imagery group ( n = 30 ) or a control group ( n = 30 ) .
-METHODS	The outcomes measures were scores for pain with the McGill Pain Questionnaire long form ( MPQ-LF ) and the Visual Analogue Scale ( VAS ) and depression with the Beck Depression Inventory and the VAS for depression .
-METHODS	The effects were examined at baseline , postintervention ( 4th week ) , and at the end of the study ( 8th week ) .
-RESULTS	Treatment efficacy was analyzed by using a t test for paired samples .
-RESULTS	Temporal changes in the scores were examined by using a 2-way repeated-measures analysis of variance .
-RESULTS	The treatment group reported statistically significantly lower levels of pain ( P < .046 ) and depression ( P < .010 ) than the control group at the week 4 evaluation .
-RESULTS	A statistically significant effect on pain as measured by the daily VAS diary was also found in the experimental group .
-RESULTS	At week 8 , no significant differences were found for pain .
-CONCLUSIONS	Patients diagnosed with fibromyalgia may benefit from this nursing intervention in terms of relieving pain and depression .
-CONCLUSIONS	Guided imagery relaxation therapy could be incorporated as part of fibromyalgia treatment to promote health among people with fibromyalgia .
-CONCLUSIONS	Guided imagery as a nursing intervention can alleviate pain and depression in patients diagnosed with fibromyalgia .
-
-###24991030
-OBJECTIVE	To characterize brain functional connectivity in subjects with prechiasmatic visual system damage and relate functional connectivity features to extent of vision loss .
-METHODS	In this case-control study , resting-state , eyes-closed EEG activity was recorded in patients with partial optic nerve damage ( n = 15 ) and uninjured controls ( n = 13 ) .
-METHODS	We analyzed power density and functional connectivity ( coherence , Granger causality ) , the latter as ( 1 ) between-areal coupling strength and ( 2 ) individually thresholded binary graphs .
-METHODS	Functional connectivity was then modulated by noninvasive repetitive transorbital alternating current stimulation ( rtACS ; 10 days , 40 minutes daily ; n = 7 ; sham , n = 8 ) to study how this would affect connectivity networks and perception .
-RESULTS	Patients exhibited lower spectral power ( p = 0.005 ) , decreased short - ( p = 0.015 ) and long-range ( p = 0.033 ) coherence , and less densely clustered coherence networks ( p = 0.025 ) in the high-alpha frequency band ( 11-13 Hz ) .
-RESULTS	rtACS strengthened short - ( p = 0.003 ) and long-range ( p = 0.032 ) alpha coherence and this was correlated with improved detection abilities ( r = 0.57 , p = 0.035 ) and processing speed ( r = 0.56 , p = 0.049 ) , respectively .
-CONCLUSIONS	Vision loss in the blind is caused not only by primary tissue damage but also by a breakdown of synchronization in brain networks .
-CONCLUSIONS	Because visual field improvements are associated with resynchronization of alpha band coherence , brain connectivity is a key component in partial blindness and in restoration of vision .
-
-###25359384
-OBJECTIVE	To compare the effects on left ventricular ( LV ) function of right ventricular ( RV ) septal pacing vs. cardiac resynchronization therapy ( CRT ) in patients with an indication for the latter .
-OBJECTIVE	Cardiac resynchronization therapy is an effective therapy in patients with drug-refractory heart failure .
-OBJECTIVE	Despite advances in implantation techniques , LV lead placement can be impossible in up to 10 % of cases .
-OBJECTIVE	We , therefore , assessed the effects of RV septal pacing from mid septum ( RVmIVS ) and outflow tract ( RVOT ) on cardiac performance , in comparison with CRT .
-RESULTS	Twenty-two patients scheduled for CRT underwent dual-chamber temporary pacing .
-RESULTS	The ventricular lead was placed at the RV apex ( RVA ) , RVmIVS , and RVOT in random order .
-RESULTS	Comprehensive echocardiography was performed in a baseline AAI mode and then at each RV position in dual chamber pacemaker function ( D pacing , D sensing , D dual responses ) mode and repeated on the next day following CRT implantation .
-RESULTS	Right ventricular apex pacing did not change any of the assessed echocardiography parameters .
-RESULTS	Both RVmIVS and RVOT pacing increased LV ejection fraction ( EF ) : 29 7 % at baseline vs. 32 6 % ( P = 0.02 ) and 32 5 % ( P = 0.04 ) with RVmIVS and RVOT pacing , respectively .
-RESULTS	Similarly , the dyssynchrony index ( Ts-SD ) decreased : 50 19 ms at baseline vs. 39 17 ms ( P = 0.04 ) and 37 17 ms ( P = 0.006 ) with RVmIVS and RVOT pacing , respectively .
-RESULTS	Cardiac resynchronization therapy further improved LVEF and Ts-SD to 36 7 % and 34 15 ms , respectively , however , only LVEF was significantly higher compared with RVmIVS and RVOT pacing ( P = 0.03 and P = 0.01 respectively ) .
-RESULTS	There were no significant differences in either LVEF or Ts-SD between RVmIVS and RVOT .
-CONCLUSIONS	Right ventricular septal pacing from mid septum or RVOT pacing improves LVEF and LV synchrony in CRT candidates .
-CONCLUSIONS	Further improvement in LVEF was achieved by CRT , which remains the ` gold standard ' therapy in these patients .
-CONCLUSIONS	However , RV septal pacing is worthy of further study as an alternative strategy when LV lead implantation fails .
-
-###25640408
-OBJECTIVE	To investigate variables associated with myopic progression despite treatment in the Atropine in the Treatment of Myopia Study .
-METHODS	Retrospective cohort study .
-METHODS	Two hundred of 400 children were randomized to receive atropine 1 % in 1 eye only in this institutional study .
-METHODS	Children were followed up with cycloplegic autorefraction every 4 months over 2 years .
-METHODS	Children whose myopia progressed by more than 0.5 diopter ( D ) in the atropine-treated eye at 1 year were classified as being progressors .
-RESULTS	Among the 182 children still in the study at 1 year , 22 ( 12.1 % ) were classified as progressors .
-RESULTS	Univariate analysis suggested these children tended to be younger ( 8.5 1.4 years vs 9.3 1.5 years ; P = .023 ) , to have higher myopic spherical equivalent ( SE ) at baseline ( -3.6 1.3 D vs -2.8 1.4 D ; P = .015 ) , and to have 2 myopic parents ( 77.3 % vs 48.1 % ; P = .012 ) .
-RESULTS	In nonprogressors , the myopia progression at 1 year was less in the atropine-treated eyes compared with the untreated fellow eye ( +0.16 0.37 D vs -0.73 0.48 D ; P < .001 ) , but in progressors , progression was more similar between eyes ( -0.92 0.31 D vs -1.06 0.44 D ; P = .363 ) .
-RESULTS	Regression analysis showed that the risk of being a progressor was 40 % lower with each year of increased age , 43 % lower for every 1.0 D less in myopia at baseline , and 59 % lower for every 1.0 D less in myopic change in the untreated eyes over the first year .
-CONCLUSIONS	Doctors and parents need to be aware that there is a small group of children ( younger , with higher myopia , and greater tendency of myopic progression ) who may still progress while receiving atropine treatment .
-
-###24678807
-BACKGROUND	Combined treatment of a calcium antagonist and / - adrenoreceptor blocker is expected to offer some advantages in the management of hypertension ; however , their antihypertensive efficacy and safety remain relatively under-explored .
-METHODS	The current study addresses the 24-h antihypertensive efficacy and safety of arotinolol combined with a different calcium channel blocker .
-METHODS	One-hundred fifty-two patients were randomly divided into three groups : nifedipine , amlodipine and felodipine group .
-METHODS	In each group , the antihypertensive treatment dose was 30mg/d , 5mg/d , 5mg/d long acting nifedipine , amlodipine , felodipine plus 20mg/d arotinolol , respectively .
-METHODS	Blood pressure was measured in ABPM devices and mercury manometer .
-RESULTS	The result showed that the effective rate of one year antihypertensive treatment of arotinolol combined with nifedipine was 51 of 53 , significantly effective ( p < 0.05 ) among three combinations .
-RESULTS	It also showed that there was no statistical significant difference ( p > 0.05 ) in controlled rate of morning peak blood pressure between treatment of arotinolol combined with amlodipine and arotinolol combined with nifedipine , but there was a significant difference ( p < 0.01 ) in controlled rate of morning peak blood pressure between arotinolol combined with nifedipine vs. felodipine and arotinolol combined with amlodipine vs. felodipine .
-CONCLUSIONS	The therapy approached of arotinolol combined with nifedipine or amlodipine could be effective and well-tolerated , and they can be used as the better chosen antihypertensive drug .
-
-###24320832
-OBJECTIVE	Most research on the Illness Management and Recovery ( IMR ) program for people with severe mental illnesses has focused on individuals with stable symptoms living in the community , with less attention to persons being treated in an inpatient setting .
-OBJECTIVE	We evaluated the feasibility and effects of an IMR program adapted for individuals with schizophrenia who were awaiting discharge into the community .
-METHODS	A randomized controlled trial was conducted at 2 hospitals in Taiwan to compare the adapted IMR program with treatment as usual ( TAU ) .
-METHODS	Ninety-seven individuals with schizophrenia were randomized to the adapted IMR program or TAU .
-METHODS	Four outcome indicators including illness-management knowledge , attitudes toward medication , insight , and symptoms were assessed at baseline , posttreatment , and at a 1-month follow-up following discharge from the hospital .
-RESULTS	Participants in the adapted IMR group showed significantly greater improvements at posttreatment and 1-month follow-up in illness-management knowledge , attitudes toward medication , insight , and negative symptoms on the Brief Psychiatric Rating Scale ( BPRS ) than individuals in the TAU group .
-RESULTS	There were no significant differences between the 2 groups on other subscales of the BPRS .
-CONCLUSIONS	This is the first controlled evaluation of a version of the IMR program in an East Asian culture , and the first to evaluate it in an acute care inpatient setting .
-CONCLUSIONS	Our findings support the feasibility and potential benefits of implementing an adapted IMR program , focused on the prevention of relapses and rehospitalizations , during the discharge period of an inpatient treatment stay to prepare individuals to reenter the community .
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-###24767671
-BACKGROUND	Following discharge home from the ICU , patients often suffer from reduced physical function , exercise capacity , health-related quality of life and social functioning .
-BACKGROUND	There is usually no support to address these longer term problems , and there has been limited research carried out into interventions which could improve patient outcomes .
-BACKGROUND	The aim of this study is to investigate the effectiveness and cost-effectiveness of a 6-week programme of exercise on physical function in patients discharged from hospital following critical illness compared to standard care .
-METHODS	The study design is a multicentre prospective phase II , allocation-concealed , assessor-blinded , randomised controlled clinical trial .
-METHODS	Participants randomised to the intervention group will complete three exercise sessions per week ( two sessions of supervised exercise and one unsupervised session ) for 6weeks .
-METHODS	Supervised sessions will take place in a hospital gymnasium or , if this is not possible , in the participants home and the unsupervised session will take place at home .
-METHODS	Blinded outcome assessment will be conducted at baseline after hospital discharge , following the exercise intervention , and at 6months following baseline assessment ( or equivalent time points for the standard care group ) .
-METHODS	The primary outcome measure is physical function as measured by the physical functioning subscale of the Short-Form-36 health survey following the exercise programme .
-METHODS	Secondary outcomes are health-related quality of life , exercise capacity , anxiety and depression , self efficacy to exercise and healthcare resource use .
-METHODS	In addition , semi-structured interviews will be conducted to explore participants ' perceptions of the exercise programme , and the feasibility ( safety , practicality and acceptability ) of providing the exercise programme will be assessed .
-METHODS	A within-trial cost-utility analysis to assess the cost-effectiveness of the intervention compared to standard care will also be conducted .
-CONCLUSIONS	If the exercise programme is found to be effective , this study will improve outcomes that are meaningful to patients and their families .
-CONCLUSIONS	It will inform the design of a future multicentre phase III clinical trial of exercise following recovery from critical illness .
-CONCLUSIONS	It will provide useful information which will help the development of services for patients after critical illness .
-BACKGROUND	ClinicalTrials.gov NCT01463579 .
-
-###25749601
-BACKGROUND	The primary aims of this hybrid Type 1 effectiveness-implementation trial were to quantitatively assess whether an evidence-based exercise intervention for breast cancer survivors , Strength After Breast Cancer , was safe and effective in a new setting and to qualitatively assess barriers to implementation .
-METHODS	A cohort of 84 survivors completed measurements related to limb volume , muscle strength , and body image at baseline , 67 survivors completed measurements 12 months later .
-METHODS	Qualitative methods were used to understand barriers to implementation experienced by referring oncology clinicians and physical therapists who delivered the program .
-RESULTS	Similar to the efficacy trial , the revised intervention demonstrated safety with regard to lymphedema , and led to improvements in lymphedema symptoms , muscular strength , and body image .
-RESULTS	Comparison of effects in the effectiveness trial to effects in the efficacy trial revealed larger strength increases in the efficacy trial than in the effectiveness trial ( P < .04 ) , but few other differences were found .
-RESULTS	Qualitative implementation data suggested significant barriers around intervention characteristics , payment , eligibility criteria , the referral process , the need for champions ( ie , advocates ) , and the need to adapt during implementation of the intervention , which should be considered in future dissemination and implementation efforts .
-CONCLUSIONS	This trial successfully demonstrated that a physical therapy led strength training program for breast cancer survivors can be implemented in a community setting while retaining the effectiveness and safety of the clinical trial .
-CONCLUSIONS	However , during the translation process , strategies to reduce barriers to implementation are required .
-CONCLUSIONS	This new program can inform larger scale dissemination and implementation efforts .
-
-###24840230
-BACKGROUND	Physical activity has been related to improved breast cancer outcomes .
-BACKGROUND	Especially in the older breast cancer population , physical activity may be important because old age is associated with comorbidities and decreased physical function .
-BACKGROUND	The purpose of this study was to investigate the relation between physical activity and overall survival , breast cancer-specific survival , and recurrence in several age groups of postmenopausal breast cancer patients .
-METHODS	The Tamoxifen Exemestane Adjuvant Multinational Lifestyle study was a side study of the Tamoxifen Exemestane Adjuvant Multinational trial and prospectively investigated lifestyle habits of postmenopausal , hormone receptor-positive breast cancer patients .
-METHODS	The relations between prediagnosis and postdiagnosis physical activity and overall survival , breast cancer-specific survival , and recurrence-free survival were assessed with Cox regression and competing risk regression models .
-RESULTS	Among 521 patients , high levels of physical activity before and after the diagnosis were associated with better overall survival ( the multivariate hazard ratios were 0.50 [ 95 % confidence interval = 0.26-0 .98 ] and 0.57 ( 95 % confidence interval = 0.26-1 .40 ] for patients who were very active before and after the diagnosis , respectively , in comparison with inactive patients ) .
-RESULTS	This was most evident in patients who were 65 years old or older .
-RESULTS	Physical activity was not significantly associated with breast cancer-specific survival or the relapse-free period .
-CONCLUSIONS	Overall survival was better for patients who were active before and after the diagnosis .
-CONCLUSIONS	In contrast with previous studies , breast cancer survival and the risk of recurrence were not significantly associated with physical activity .
-CONCLUSIONS	These findings confirmed the need for more studies investigating the use of physical activity to supplement breast cancer treatment in older patients .
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-###24385636
-OBJECTIVE	This article investigated how a multicomponent memory intervention affected memory for prose .
-OBJECTIVE	We compared verbatim and paraphrased recall for short stories immediately and 1 , 2 , 3 , and 5 years post-intervention in the Advanced Cognitive Training for Independent and Vital Elderly ( ACTIVE ) sample .
-METHODS	We studied 1,912 ACTIVE participants aged 65 to 91 .
-METHODS	Participants were randomized into one of three training arms ( Memory , Reasoning , Speed of Processing ) or a no-contact Control group ; about half of the trained participants received additional booster training 1 and 3 years post-intervention .
-RESULTS	Memory-trained participants showed higher verbatim recall than non-memory-trained participants .
-RESULTS	Booster-memory training led to higher verbatim recall .
-RESULTS	Memory training effects were evident immediately following training and not after 1 year following training .
-CONCLUSIONS	Results suggest that multifactorial memory training can improve verbatim recall for prose , but the effect does not last without continued intervention .
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-###24908910
-OBJECTIVE	This study was developed as a pilot study to determine if targeted interventions regarding increasing physical activity level through the use of pedometers and fitness DVDs would result in a decrease in BMI in overweight or obese children .
-METHODS	24 children aged 4-17 taking part in `` Moving and Losing '' were randomized to ( 1 ) Control Group ; ( 2 ) Pedometer Group ; ( 3 ) DVD Group ; ( 4 ) Pedometer + DVD Group and asked to complete self-report physical activity logs at visit one and two .
-METHODS	Baseline , midpoint , and endpoint weight , height , Body Mass Index ( BMI ) were measured for outcome variables .
-RESULTS	Almost half ( 42 % ) of participants turned in their activity logs and pedometers at midpoint , but at endpoint less than a quarter of participants turned in their pedometers and/or activity logs .
-RESULTS	BMI increased by 4.1 % in the Control Group , 8.7 % in the Pedometer Group , and 6.7 % in the DVD Group .
-RESULTS	BMI decreased by 0.3 % in the Pedometer + DVD Group .
-CONCLUSIONS	The use of pedometers and fitness DVDs may not be culturally acceptable in African-American female children and adolescents from South Carolina who are overweight or obese .
-CONCLUSIONS	Further studies should look into in-depth needs assessments and planning processes that include participants as stakeholders .
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-###25027304
-BACKGROUND	Bronchodilator medications are central to the symptomatic management of chronic obstructive pulmonary disease ( COPD ) .
-BACKGROUND	Metered-dose inhalers ( MDIs ) are the most commonly used devices to deliver treatment to patients with COPD and asthma , comprising approximately 70 % of bronchodilator prescriptions .
-BACKGROUND	Proprietary porous-particle technology permits the formulation of long-acting muscarinic antagonists , long-acting 2-agonists , and a combination of both in hydrofluoroalkane ( HFA ) MDIs , providing a solution to formulation challenges inherent to the development of HFA MDIs , which have contributed to the development of dry-powder inhalers .
-METHODS	In this randomized , double-blind , 4-period , 6-treatment , placebo - and active-controlled , multicenter , crossover study , 4 ascending single doses of a proprietary glycopyrronium ( GP ) MDI were evaluated compared with Placebo MDI and open-label tiotropium ( TIO ) in study patients with COPD .
-METHODS	Thirty-three study patients were enrolled and received single-dose administration of 4 of the 6 treatments ( Placebo MDI , TIO 18 g , or GP MDI at 14.4 , 28.8 , 57.6 , and 115.2 g ex-actuator ) with an interval of 1 to 3 weeks between doses .
-METHODS	The primary efficacy endpoint was peak change in forced expiratory volume in 1 second ( FEV1 ) .
-RESULTS	All 4 doses of GP MDI showed statistically superior efficacy compared with Placebo MDI for peak FEV1 ( differences of 146 to 248 mL ; P < .001 ) , with a clear dose ordering of the response .
-RESULTS	Statistically significant differences compared with Placebo MDI were noted at almost all doses for the secondary FEV1 parameters ( P .049 ) except 24-hour trough FEV1 at 28.8 g. All doses were safe and well tolerated in this study ; the most frequently reported adverse event was dry mouth ( 0-14 .3 % across doses ; 9.5 % for Placebo MDI , and 9.1 % for TIO ) .
-CONCLUSIONS	This study demonstrated superior bronchodilatory efficacy of GP MDI compared with Placebo MDI at all doses tested , and no serious adverse events were reported .
-CONCLUSIONS	This study supports the further evaluation of GP MDI in study patients with COPD .
-CONCLUSIONS	In addition , these findings indicate that the correct dosage of glycopyrronium is no more than 115.2 g total daily dose , or 57.6 g twice daily based on comparisons with the active comparator .
-BACKGROUND	This clinical trial was registered on ClinicalTrials.gov , Identifier : NCT00871182 .
-
-###25266433
-OBJECTIVE	We aimed to determine the timing and size of the cognitive deficit associated with poverty in the first 5 years of life and to examine the role of parental characteristics , pre - and postnatal growth , and stimulation in the home in Bangladeshi children .
-OBJECTIVE	We hypothesized that the effect of poverty on cognition begins in infancy and is mainly mediated by these factors .
-METHODS	We enrolled 2853 singletons , a subsample from a pregnancy supplementation trial in a poor rural area .
-METHODS	We assessed mental development at 7 , 18 , and 64 months ; anthropometry at birth , 12 , 24 , and 64 months ; home stimulation at 18 and 64 months ; and family 's socioeconomic background .
-METHODS	In multiple regression analyses , we examined the effect of poverty at birth on IQ at 64 months and the extent that other factors mediated the effect .
-RESULTS	A mean cognitive deficit of 0.2 ( 95 % confidence interval -0.4 to -0.02 ) z scores between the first and fifth wealth quintiles was apparent at 7 months and increased to 1.2 ( 95 % confidence interval -1.3 to -1.0 ) z scores of IQ by 64 months .
-RESULTS	Parental education , pre - and postnatal growth in length , and home stimulation mediated 86 % of the effects of poverty on IQ and had independent effects .
-RESULTS	Growth in the first 2 years had larger effects than later growth .
-RESULTS	Home stimulation had effects throughout the period .
-CONCLUSIONS	Effects of poverty on children 's cognition are mostly mediated through parental education , birth size , growth in the first 24 months , and home stimulation in the first 5 years .
-
-###25009402
-OBJECTIVE	To compare the short-term outcomes of patients who underwent proximal gastrectomy with jejunal interposition ( PGJI ) with those undergoing total gastrectomy with Roux-en-Y anastomosis ( TGRY ) .
-METHODS	From January 2009 to January 2011 , thirty-five patients underwent PGJI , and forty-one patients underwent TGRY .
-METHODS	The surgical efficacy and short-term follow-up outcomes were compared between the two groups .
-RESULTS	There were no differences in the demographic and clinicopathological characteristics .
-RESULTS	The mean operation duration and postoperative hospital stay in the PGJI group were statistically longer than those in the TGRY group ( P = 0.00 ) .
-RESULTS	No anastomosis leakage was observed in two groups .
-RESULTS	No statistically significant difference was found in endoscopic findings , Visick grade or serum albumin level .
-RESULTS	The single-meal food intake in the PGJI group was more than that in the TGRY group ( P = 0.00 ) .
-RESULTS	The PG group showed significantly better hemoglobin levels in the second year ( P = 0.02 ) .
-RESULTS	The two-year survival rate was not significantly different ( PGJI vs TGRY , 93.55 % vs 92.5 % , P = 1.0 ) .
-CONCLUSIONS	PGJI is a safe , radical surgical method for proximal gastric cancer and leads to better outcomes in terms of the single-meal food intake and hemoglobin level , compared with TGRY in the short term .
-
-###25098611
-OBJECTIVE	An endoscopic ultrasound ( EUS ) - guided fine needle biopsy ( EUS-FNB ) device using a core biopsy needle was developed to improve diagnostic accuracy by simultaneously obtaining cytological aspirates and histological core samples .
-OBJECTIVE	We prospectively compared the diagnostic accuracy of EUS-FNB with standard EUS-guided fine needle aspiration ( EUS-FNA ) in patients with solid pancreatic masses .
-METHODS	Between January 2012 and May 2013 , consecutive patients with solid pancreatic masses were prospectively enrolled and randomized to undergo EUS-FNB using a core biopsy needle or EUS-FNA using a standard aspiration needle at a single tertiary center .
-METHODS	The specimen was analyzed by onsite cytology , Papanicolaou-stain cytology , and histology .
-METHODS	The main outcome measure was diagnostic accuracy for malignancy .
-METHODS	The secondary outcome measures were : the median number of passes required to establish a diagnosis , the proportion of patients in whom the diagnosis was established with each pass , and complication rates .
-RESULTS	The overall accuracy of combining onsite cytology with Papanicolaou-stain cytology and histology was not significantly different for the FNB ( n = 58 ) and FNA ( n = 58 ) groups ( 98.3 % [ 95 % CI 94.9 % -100 % ] vs. 94.8 % [ 95 % CI 91.9 % -100 % ] ; P = 0.671 ) .
-RESULTS	Compared with FNA , FNB required a significantly lower median number of needle passes to establish a diagnosis ( 1.0 vs. 2.0 ; P < 0.001 ) .
-RESULTS	On subgroup analysis of 111 patients with malignant lesions , the proportion of patients in whom malignancy was diagnosed on the first pass was significantly greater in the FNB group ( 72.7 % vs. 37.5 % ; P < 0.001 ) .
-CONCLUSIONS	The overall accuracy of FNB and FNA in patients with solid pancreatic masses was comparable ; however , fewer passes were required to establish the diagnosis of malignancy using FNB.This study was registered on the UMIN Clinical Trial Registry ( UMIN000014057 ) .
-
-###25266981
-BACKGROUND	Patients with recurrent sinonasal polyposis after endoscopic sinus surgery ( ESS ) have limited treatment options .
-BACKGROUND	This study evaluated the safety and efficacy of a bioabsorbable steroid-eluting implant with 1350 g of mometasone furoate for its ability to dilate obstructed ethmoid sinuses , reduce polyposis , and reestablish sinus patency .
-METHODS	This was a randomized , controlled , blinded study including 100 patients chronic rhinosinusitis with nasal polyposis ( CRSwNP ) refractory to medical therapy and considered candidates for revision ESS .
-METHODS	Follow-up included endoscopic grading by investigators and patient-reported outcomes .
-RESULTS	Treated patients ( n = 53 ; age as mean standard deviation [ SD ] 47.8 12.6 years ; 55 % male ) underwent in-office bilateral placement .
-RESULTS	Control patients ( n = 47 ; age 51.6 13.1 years ; 66 % male ) underwent a sham procedure .
-RESULTS	At 3months , treated patients experienced a significant reduction in bilateral polyp grade ( p = 0.0269 ) and ethmoid sinus obstruction ( p = 0.0001 ) compared to controls .
-RESULTS	Treated patients also experienced a 2-fold improvement in the mean nasal obstruction/congestion score ( -1.33 1.47 vs -0.67 1.45 ; p = 0.1365 ) .
-RESULTS	This improvement reached statistical significance ( p = 0.025 ) in patients with greater polyp burden ( grade 2 bilaterally ; n = 74 ) .
-RESULTS	At 3months , 53 % of treated patients compared to only 23 % of controls were no longer indicated for repeat ESS .
-RESULTS	There was no serious adverse event or clinically significant increases in intraocular pressure or cataract formation .
-CONCLUSIONS	The symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS .
-CONCLUSIONS	The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population .
-
-###25416514
-BACKGROUND	Chronic Low Back Pain is a complex syndrome with multifactorial bio-psycho-social etiology and interdependences .
-BACKGROUND	Thereby , physical activity seems to play an essential role regarding the prevention and rehabilitation of LBP .
-BACKGROUND	In consequence , physical activity and exercise therapy is an integral part of musculoskeletal rehabilitation in LBP .
-BACKGROUND	However , adherence to self-directed exercise and implementing a health-enhancing physical activity in daily routine after rehabilitation is a common problem for patients and only a few patients integrate health-enhancing physical activity and/or sport activities in their lifestyle .
-BACKGROUND	The present paper describes a comprehensive multilevel approach combining face-to-face intervention , telephone and internet aftercare ( Movement Coaching ) .
-BACKGROUND	Aim of the trial presented in this study protocol is to evaluate effectiveness of Movement Coaching compared to a control intervention .
-METHODS	The study is a prospective , single-blinded , monocenter randomized controlled trial ( RCT ) with three measuring points : T1 = start of inpatient rehabilitation ; T2 = six months follow-up ; T3 = twelve months follow-up .
-METHODS	In total , 412 patients were recruited .
-METHODS	The intervention involves small-group face-to-face contact during inpatient rehabilitation ( two times , week 2 & 3 ) and telephone aftercare ( week 8 & week 12 after rehabilitation ) as well as internet-based aftercare ( web 2.0 platform ; available until six months after rehabilitation ) .
-METHODS	Primary outcome is physical activity , assessed by GPAQ questionnaire .
-METHODS	The final data collection is expected by April 2015 .
-CONCLUSIONS	Due to the burden of physical inactivity , there is a need to develop , evaluate and disseminate approaches that are effective in promoting physical activity and especially promoting the maintenance of physical activity in relevant target groups .
-CONCLUSIONS	Considering the high prevalence and socioeconomic impact of low back pain and its multifactorial etiology , low back pain patients seem to be a relevant target group for physical activity promotion .
-CONCLUSIONS	A multilevel approach to bridge the interface of ( inpatient ) rehabilitation and self-directed physical activity will help to target group-specific PA promotion .
-BACKGROUND	German Clinical Trials Register ( DRKS ) - ID : DRKS00004878 .
-
-###25278139
-BACKGROUND	There is controversy about the efficacy of currently used treatment modalities to alleviate migraine headaches .
-OBJECTIVE	We aimed to evaluate and compare the effects of magnesium sulfate and combined use of dexamethasone/metoclopramide on relieving acute migraine headache .
-METHODS	We randomly divided 70 patients who had been referred to an emergency department , into two equal treatment groups with the two treatment plans , and analyzed pain severity at baseline using a numeric rating scale ( NRS ) .
-METHODS	We gave dexamethasone/metoclopramide to one group and magnesium sulfate to the other group , and evaluated pain severity at 20 min and at 1 - and 2-h intervals after infusion .
-METHODS	Finally , we used repeated-measure and two-way analysis of variance for intra - and inter-group evaluations of pain severity and complications , respectively .
-RESULTS	We found no significant differences in demographic data and pain severity at baseline ( 8.2 vs. 8.0 ) between the two groups ( p < 0.05 ) .
-RESULTS	In the dexamethasone/metoclopramide group , pain severity ( mean standard deviation ) was 7.4 1.4 ( p = 0.36 ) , 6.0 2.4 , and 2.5 2.9 ( p < 0.0001 ) at 20-min , 1-h , and 2-h intervals after treatment , respectively , with statistically significant differences between the baseline values and 1-h and 2-h interval values .
-RESULTS	Administration of magnesium sulfate was associated with decreased pain severity at the three intervals ( 5.2 1.7 , 2.3 1.9 , and 1.3 0.66 , respectively ) , exhibiting significant differences compared to baseline values and the corresponding time intervals in the dexamethasone/metoclopramide group ( p < 0.0001 ) .
-CONCLUSIONS	According to the results , magnesium sulfate was a more effective and fast-acting medication compared to a combination of dexamethasone/metoclopramide for the treatment of acute migraine headaches .
-
-###25310146
-OBJECTIVE	The association between the interleukin IL1 beta gene polymorphisms SNP-511 and SNP +3953 and susceptibility to the development of Hashimoto 's thyroiditis among adult Caucasian-Polish population were analyzed .
-METHODS	The group studied comprised of 115 unrelated patients with Hashimoto 's thyroiditis ( 112 women and 3 men , mean age 53.3 years ) .
-METHODS	All patients were euthyroid on thyroid replacement therapy , had extremely high serum anti-TPO levels and in 53 patients anti-TG levels were also increased .
-METHODS	The control group consisted of 103 healthy blood donors without raised anti-TPO antibodies , in whom a personal and familial history of thyroid , autoimmune and inflammatory diseases was excluded .
-METHODS	No goiter or thyroid dysfunction was found .2 polymorphisms of the IL1 beta were studied by PCR-RFLP analysis .
-METHODS	To confirm the accuracy of the method used , randomly selected patients were analyzed by direct sequencing .
-RESULTS	In both groups allele frequencies were in Hardy-Weinberg equilibrium .
-RESULTS	The significant statistical differences between the frequency of C and T allele for both SNPs ( C-511T and C +3953 T ) in the group studied and in the controls were found ( p = 0.0081 ; OR = 1.846 ; 95 % CI : 1.183-2 .878 and p = 0.0099 ; OR = 1.953 ; 95 % CI : 1.183-3 .224 ) .
-RESULTS	The frequencies of the genotype C-511C compared to C-511T and T-511T as well as C +3953 C compared to C +3953 T and T +3953 T also differed significantly ( p = 0.0057 ; OR = 2.248 ; 95 % CI : 1.292-3 .912 and p = 0.0043 ; OR = 2.338 ; 95 % CI : 1.305-4 .191 ) between patients and controls .
-CONCLUSIONS	An association between the SNPs of the IL1 beta and susceptibility to Hashimoto 's thyroiditis among the group of Caucasian-Polish population studied was found .
-
-###25981049
-BACKGROUND	Antalgic radiotherapy for bone metastases might be improved by implementing biological information in the radiotherapy planning using ( 18 ) F-FDG-PET-CT based dose painting by numbers ( DPBN ) .
-METHODS	Patients with uncomplicated painful bone metastases were randomized ( 1:1:1 ) and blinded to receive either 8Gy in a single fraction with conventionally planned radiotherapy ( arm A ) or 8Gy in a single fraction with DPBN ( dose range between 610Gy and 10Gy ) ( arm B ) or 16Gy in a single fraction with DPBN ( dose range between 1410Gy and 18Gy ) ( arm C ) .
-METHODS	The primary endpoint was overall pain response at 1month .
-METHODS	The phase II trial was designed to select the experimental arm with sufficient promise of efficacy to continue to a phase III trial .
-RESULTS	Forty-five patients were randomized .
-RESULTS	Eight ( 53 % ) , 12 ( 80 % ) and 9 patients ( 60 % ) had an overall response to treatment in arm A , B and C , respectively .
-RESULTS	The estimated odds ratio of overall response for arm B vs. A is 3.5 ( 95 % CI : 0.44-17 .71 , p = 0.12 ) .
-RESULTS	The estimated odds ratio of arm C vs. A is 1.31 ( 95 % CI : 0.31-5 .58 , p = 0.71 ) .
-CONCLUSIONS	A single fraction of 8Gy with DPBN will be further evaluated in a phase III-trial .
-
-###24650400
-OBJECTIVE	This study evaluated the impact of nonculprit vessel myocardial perfusion on outcomes of non-ST-segment elevation acute coronary syndromes ( NSTE-ACS ) patients .
-BACKGROUND	ST-segment elevation myocardial infarction patients have decreased perfusion in areas remote from the infarct-related vessel .
-BACKGROUND	The impact of myocardial hypoperfusion of regions supplied by nonculprit vessels in NSTE-ACS patients treated with percutaneous coronary intervention ( PCI ) is unknown .
-METHODS	The angiographic substudy of the ACUITY ( Acute Catheterization and Urgent Intervention Triage Strategy ) trial included 6,921 NSTE-ACS patients .
-METHODS	Complete 3-vessel assessments of baseline coronary TIMI ( Thrombolysis In Myocardial Infarction ) flow grade and myocardial blush grade ( MBG ) were performed .
-METHODS	We examined the outcomes of PCI-treated patients according to the worst nonculprit vessel MBG identified per patient .
-RESULTS	Among the 3,826 patients treated with PCI , the worst nonculprit MBG was determined in3 ,426 ( 89.5 % ) patients , including 375 ( 10.9 % ) MBG 0/1 patients , 475 ( 13.9 % ) MBG 2 patients , and 2,576 ( 75.2 % ) MBG 3 patients .
-RESULTS	Nonculprit MBG 0/1 was associated with worse baseline clinical characteristics .
-RESULTS	Patients with nonculprit MBG 0/1 versus MBG 3 had increased rates of 30-day ( 3.0 % vs. 0.7 % , p < 0.0001 ) and 1-year ( 4.4 % vs. 1.0 % , p < 0.0001 ) death .
-RESULTS	Similar results were found among patients with pre-procedural TIMI flow grade 3 in the culprit vessel , where nonculprit vessel MBG 0/1 ( hazard ratio : 2.81 [ 95 % confidence interval : 1.63 to 4.84 ] , p = 0.0002 ) was the strongest predictor of 1-year mortality .
-CONCLUSIONS	Reduced myocardial perfusion in an area supplied by a nonculprit vessel is associated with increased short - and long-term mortality rates in NSTE-ACS patients undergoing PCI .
-CONCLUSIONS	Furthermore , worst nonculprit MBG is able to risk-stratify patients with normal baseline flow of the culprit vessel .
-
-###25171575
-BACKGROUND	Mechanical insufflation-exsufflation ( MI-E ) , more commonly known as ` cough assist therapy ' , is a method which produces inspiratory and expiratory assistance to improve cough performances .
-BACKGROUND	However , other alternatives or combinations are possible .
-OBJECTIVE	The objective was to compare the effects of mechanical insufflation combined with manually assisted coughing ( MAC ) , insufflation-exsufflation alone and insufflation-exsufflation combined with MAC in neuromuscular patients requiring cough assistance .
-METHODS	Eighteen neuromuscular patients with severe respiratory muscle dysfunction and peak cough flow ( PCF ) lower than 3 liters/s or maximal expiratory pressure ( MEP ) lower than +45 cm H2O were studied .
-METHODS	Patients were studied under three cough-assisted conditions , which were used in random order : insufflation by intermittent positive-pressure breathing ( IPPB ) combined with MAC , MI-E and MI-E + MAC .
-RESULTS	Overall , PCF was higher with IPPB + MAC than with MI-E + MAC or MI-E alone .
-RESULTS	Among the 12 patients who had higher PCF values with IPPB + MAC than with the two other techniques , 9 exhibited mask pressure swings during MI-E exsufflation , with a transient positive-pressure value due to the expiratory flow produced by the combined patient cough effort and MAC .
-RESULTS	Each of these 9 patients had higher PCF values ( > 5 liters/s ) than did the other 9 patients when using IPPB + MAC .
-CONCLUSIONS	Our results indicate that adding the MI-E device to MAC is unhelpful in patients whose PCF with an insufflation technique and MAC exceeds 5 liters/s .
-CONCLUSIONS	This is because the expiratory flow produced by the patient 's effort and MAC transitorily exceeds the vacuum capacity of the MI-E device , which therefore becomes a transient load against the PCF .
-
-###24781718
-OBJECTIVE	The objective of this study was to evaluate the safety and efficacy of SprayShield Adhesion Barrier in preventing and/or reducing postoperative adhesion during gynecological surgery .
-METHODS	This was a prospective , controlled , blinded , and randomized study .
-METHODS	Patient blinding was performed intraoperatively .
-METHODS	Subjects were randomly assigned to the SprayShield or the control group in a 2:1 ratio .
-METHODS	The study was conducted at the Clinic of Gynaecology and Obstetrics , at the University Hospital for Gynecology in Germany .
-METHODS	Fifteen patients participated in this study ; nine patients were assigned to the SprayShield and six patients to the control group .
-METHODS	During first operation ( FLL ) in the SprayShield group , the agent was applied to all myomectomy suture lines .
-METHODS	Patients in the control group did not receive any anti-adhesion treatment , only good surgical practice .
-METHODS	A second-look laparoscopy ( SLL ) was performed 8-12weeks after myomectomy to evaluate adhesion formation .
-METHODS	Main outcome measures were incidence , severity , and extent of uterine adhesions .
-RESULTS	No significant differences were found between the two study groups .
-CONCLUSIONS	SprayShield is easy to use .
-CONCLUSIONS	No serious adverse event related to SprayShield was observed .
-CONCLUSIONS	Efficacy data are inconclusive regarding the performance of SprayShield .
-CONCLUSIONS	Further studies are needed to better understand this performance .
-
-###25345257
-OBJECTIVE	To compare an efficacy of a moisturizer containing spent grain wax , Butyrospermum parkii extract , Argania spinosa kernel oil ( S ) with 1 % hydrocortisone cream ( HC ) for the treatment of mild to moderate atopic dermatitis .
-METHODS	Twenty-nine patients , age between 2 and 15 years old with mild to moderate atopic dermatitis were enrolled The body was randomly divided to left and right side .
-METHODS	One side was applied with S cream and the other side was applied with HC cream twice daily for four weeks .
-METHODS	Observation of recurrence rate after remission was recorded .
-METHODS	Clinical outcomes were analyzed by using the scoring ofAtopic Dermatitis ( SCORAD ) score .
-METHODS	Statistical analysis was done by using descriptive statistics , pair t-test , one-way repeated ANOVA , and McNemar 's test .
-RESULTS	It was demonstrated that both agents had improvement of SCORAD score after two weeks , with statistically significant difference ( p < 0.001 ) .
-RESULTS	At fourth week , both agents had improvement of SCORAD score without being statistically significant different ( p > 0.05 ) .
-RESULTS	Although the S cream side had higher remission rate than the HC cream side , there was no statistically significant difference ( p > 0.05 ) .
-CONCLUSIONS	S cream was as effective as HC cream in the treatment and maintenance period of mild to moderate childhood atopic dermatitis .
-
-###25341453
-BACKGROUND	Intracranial arteriovenous malformations ( AVMs ) are associated with high morbidity and mortality .
-BACKGROUND	Modern microsurgery has improved the results of surgical treatment of AVMs ; however , the treatment of AVMs , particularly eloquently located AVMs , still carries a high risk .
-BACKGROUND	Functional MRI ( fMRI ) has been reported to be used for the preoperative evaluation of AVMs in small case series .
-BACKGROUND	The purpose is to identify the utility and efficacy of fMRI-guided microsurgery of AVMs in a large randomised controlled trial .
-METHODS	The study is a prospective , randomised controlled clinical trial .
-METHODS	This study will enrol a total of 600 eligible patients .
-METHODS	These eligible patients will be randomised to the standard microsurgery group and the fMRI-guided microsurgery group in a 1:1 ratio .
-METHODS	Patient baseline characteristics and AVM architecture and characteristics will be described .
-METHODS	In the fMRI-guided group , fMRI mapping of an eloquent cortex in all AVMs will be identified .
-METHODS	Surgical complications and outcomes at pretreatment , post-treatment , at discharge and at 1-month , 3-month and 6-month follow-up intervals will be analysed using the modified Rankin Scale ( mRS ) .
-METHODS	This trial will determine whether fMRI-guided microsurgery could improve outcomes in patients with AVMs and also identify the safety and efficacy of fMRI-guided microsurgery .
-BACKGROUND	The study protocol and written informed consent were reviewed and approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University ( ky2012-016-02 ) .
-BACKGROUND	Study findings will be disseminated in the printed media .
-BACKGROUND	ClinicalTrials.gov NCT01758211 .
-
-###24237724
-OBJECTIVE	Definitive therapy is not defined for the management of oral submucous fibrosis ( OSMF ) .
-OBJECTIVE	This study evaluated the efficacy of aloe vera gel as an adjuvant treatment of OSMF .
-METHODS	A double-blind , placebo-controlled , parallel-group randomized controlled trial was conducted on 60 subjects with OSMF divided into medicinal treatment ( submucosal injection of hyaluronidase and dexamethasone , n = 30 ) and surgical treatment ( n = 30 ) categories .
-METHODS	Each category was randomly divided into groups A ( with aloe vera , n = 15 per category ) and B ( without aloe vera , n = 15 per category ) .
-METHODS	Follow-up assessment for various symptoms was performed , and results were analyzed using paired and unpaired Student t tests .
-RESULTS	The group receiving aloe vera had a significant improvement in most symptoms of OSMF ( P < .01 ) compared with the non-aloe vera group , in both the medicinal and surgical categories .
-CONCLUSIONS	Aloe vera gel was effective as an adjuvant in treatment of OSMF .
-
-###24328607
-OBJECTIVE	As clinical studies conducted to explore the safety and efficacy of new procedures are considered an important focus in endodontic research , the aim of this controlled clinical study was to compare a laser-assisted endodontic treatment using an erbium , chromium : yttrium-scandium-gallium-garnet ( Er , Cr : YSGG ) laser and radial firing tips ( RFT ) versus the conventional use of 3 % sodium hypochlorite and interim calcium hydroxide paste , in teeth with chronic apical periodontitis .
-METHODS	Forty-three single-rooted and premolar teeth were randomly assigned .
-METHODS	In group 1 , teeth were prepared and irrigated with 3 % sodium hypochlorite and calcium hydroxide inter-appointment dressing was applied ; in group 2 teeth were prepared with saline solution and irradiated with Er , Cr : YSGG laser using RFT2 ( 140 s , 37.5 mJ , 20 Hz ) and RFT3 ( 140 s , 62.5 mJ , 20 Hz ) at the first and second appointments , respectively , four times each , moving at 2 mm/sec ( -1 ) from apical to coronal .
-METHODS	The primary outcome measure was change in apical bone density at 12 months , using the periapical index ( PAI ) for blind radiographic assessment .
-RESULTS	Thirty teeth were examined and subjected to statistical analysis , 12 in the control group and 18 in the test group .
-RESULTS	There were two treatment failures in the control group that were not included for analysis ; both groups exhibited statistically significant decreases in PAI scores .
-CONCLUSIONS	The present findings suggest that for single-rooted and premolar teeth , this laser-assisted protocol can achieve predictable endodontic outcomes , comparable to conventional strategies in 1 year of follow-up .
-
-###24334800
-OBJECTIVE	To assess the relative importance of independent risk factors for peripheral intravenous catheter ( PIVC ) failure .
-METHODS	Secondary data analysis from a randomized controlled trial of PIVC dwell time .
-METHODS	The Prentice , Williams , and Peterson statistical model was used to identify and compare risk factors for phlebitis , occlusion , and accidental removal .
-METHODS	Three acute care hospitals in Queensland , Australia .
-METHODS	The trial included 3,283 adult medical and surgical patients ( 5,907 catheters ) with a PIVC with greater than 4 days of expected use .
-RESULTS	Modifiable risk factors for occlusion included hand , antecubital fossa , or upper arm insertion compared with forearm ( hazard ratio [ HR ] , 1.47 [ 95 % confidence interval ( CI ) , 1.28-1 .68 ] , 1.27 [ 95 % CI , 1.08-1 .49 ] , and 1.25 [ 95 % CI , 1.04-1 .50 ] , respectively ) ; and for phlebitis , larger diameter PIVC ( HR , 1.48 [ 95 % CI , 1.08-2 .03 ] ) .
-RESULTS	PIVCs inserted by the operating and radiology suite staff had lower occlusion risk than ward insertions ( HR , 0.80 [ 95 % CI , 0.67-0 .94 ] ) .
-RESULTS	Modifiable risks for accidental removal included hand or antecubital fossa insertion compared with forearm ( HR , 2.45 [ 95 % CI , 1.93-3 .10 ] and 1.65 [ 95 % CI , 1.23-2 .22 ] , respectively ) , clinical staff insertion compared with intravenous service ( HR , 1.69 [ 95 % CI , 1.30-2 .20 ] ) ; and smaller PIVC diameter ( HR , 1.29 [ 95 % CI , 1.02-1 .61 ] ) .
-RESULTS	Female sex was a nonmodifiable factor associated with an increased risk of both phlebitis ( HR , 1.64 [ 95 % CI , 1.28-2 .09 ] ) and occlusion ( HR , 1.44 [ 95 % CI , 1.30-1 .61 ] ) .
-CONCLUSIONS	PIVC survival is improved by preferential forearm insertion , selection of appropriate PIVC diameter , and insertion by intravenous teams and other specialists .
-BACKGROUND	The original randomized controlled trial on which this secondary analysis is based is registered with the Australian New Zealand Clinical Trials Registry ( http://www.anzctr.org.au; ACTRN12608000445370 ) .
-
-###25233647
-OBJECTIVE	To compare the differences in the clinical efficacy between Guan 's quadruple therapy for kidney disease and the conventional western medication in the treatment of chronic renal failure ( CRF ) .
-METHODS	Eighty patients were randomized into an observation group and a control group , 40 cases in each one .
-METHODS	In the observation group , besides the physician instruction of low protein and low phosphorus diet in the two groups , Guan 's quadruple therapy for kidney disease was applied , including ( 1 ) the isolated herbal moxibustion at Shenshu ( BL 23 ) and Pishu ( BL 21 ) , or Ganshu ( BL 18 ) , Zusanli ( ST 36 ) and Guanyuan ( CV 4 ) alternatively ; ( 2 ) acupuncture at the auricular points such as shen ( CO10 ) , jiaogan ( AHR6 ) , Shenshangxian ( TG2 ) , fei ( CO14 ) and pizhixia ( AT4 ) ; ( 3 ) injection of mixture of astragalus injection and lidocaine injection at Feishu ( BL 13 ) , Pishu ( BL 21 ) , Shenshu ( BL 23 ) and the others ; ( 4 ) modified Shenshuai Yihao decoction according to syndrome differentiation .
-METHODS	In the control group , the conventional western medication was used .
-METHODS	After 6 months of treatment , the differences were observed between the two groups in the clinical efficacy , serum creatinine ( Scr ) , blood urea nitrogen ( BUN ) , endogenous creatinine ( Ccr ) and 24 h urine protein quantitation ( UPQ ) .
-RESULTS	In the observation group , after treatment , the remarkably effective rate was 50.0 % ( 20/40 ) and the total effective rate was 82.5 % ( 33/40 ) , which were superior to 25.0 % ( 10/40 ) and 45.0 % ( 18/40 ) in the control group ( both P < 0.05 ) .
-RESULTS	After treatment , the levels of Scr , BUN and 24 h UPQ were reduced apparently ( all P < 0.05 ) , and the level of Ccr was increased apparently in the two groups ( both P < 0.05 ) .
-RESULTS	After treatment , the levels of Scr , BUN and 24 h UPQ were reduced much more apparently in the observation group as compared with those in the control group ( all P < 0.05 ) .
-CONCLUSIONS	Guan 's quadruple therapy for kidney disease achieves a better efficacy on CRF compared with the conventional western medication .
-CONCLUSIONS	This therapy improves renal functions , relieves clinical symptoms and physical signs and benefits the life quality of patients .
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-###24793078
-BACKGROUND	The topical gel known as `` ABH gel , '' comprising lorazepam ( Ativan ( ) ) , diphenhydramine ( Benadryl ( ) ) , and haloperidol ( Haldol ( ) ) , is frequently used to treat nausea because of its perceived efficacy , relatively low cost , and ease of use in the home setting .
-BACKGROUND	There are limited scientific data on this medication , however .
-BACKGROUND	Recent pilot studies showed no absorption of the active ingredients of the gel , prompting further prospective studies into the cause of the perceived efficacy in the clinical setting .
-OBJECTIVE	To determine any difference in the effectiveness of ABH gel compared with placebo in cancer patients with nausea .
-METHODS	A randomized , double-blind , placebo-controlled , crossover , noninferiority clinical trial was developed to test the hypothesis that there is no difference in the effectiveness of ABH gel compared with placebo in cancer patients with nausea .
-METHODS	The primary outcome was the difference in nausea score ( on a 0-10 scale ) at baseline and at 60 minutes in each treatment group .
-METHODS	The difference in the ABH gel-treated group compared with placebo was evaluated for noninferiority .
-METHODS	Secondary outcomes included the number of vomiting episodes and side effects over time .
-RESULTS	The mean change in nausea score from baseline to 60 minutes after treatment in the ABH gel group was 1.7 2.05 and 0.9 2.45 for the placebo group ( P = 0.42 ) .
-RESULTS	The placebo group was found to be noninferior to the ABH gel group in reducing the nausea score .
-RESULTS	ABH gel also did not decrease vomiting events better than placebo ( P = 0.34 ) .
-RESULTS	Only one patient reported any side effects from the treatments in either arm of the study .
-CONCLUSIONS	ABH gel in its current formulation should not be used in cancer patients experiencing nausea .
-
-###24999797
-BACKGROUND	Irritable bowel syndrome ( IBS ) is highly prevalent in young women under stressful conditions .
-BACKGROUND	Cognitive behavioral therapy ( CBT ) has been known to be effective in treating IBS .
-OBJECTIVE	This study aimed to evaluate the clinical outcomes of CBT in female nursing students with IBS .
-OBJECTIVE	The primary outcome measure of the study was the Bowel Symptom Severity Scale-IBS version .
-METHODS	Ninety diagnosed participants were randomized to each group in a randomized pretest-post-test control group design .
-METHODS	The experimental group received an 8-week CBT intervention , and the control group received general information on IBS .
-METHODS	Bowel symptom severity , dysfunctional attitudes , and IBS-quality of life were assessed at baseline and after 8 , 16 , and 24 weeks .
-METHODS	Six experimental and eight control participants withdrew during the study because of various reasons .
-RESULTS	Significant effects were found for bowel symptom severity ( frequency : P < 0.001 ; distress : P < 0.001 ; disability : P < 0.001 ) between the experimental ( n = 39 ) and the control ( n = 37 ) groups .
-RESULTS	The overall IBS-quality of life improved over time in the CBT group ( P < 0.001 ) .
-RESULTS	The CBT also showed the alleviation of dysphoria ( P = 0.010 ) , interference with activity ( P = 0.031 ) , and health worry ( P = 0.009 ) , and the improvement of body image ( P = 0.008 ) and relationships ( P = 0.041 ) compared with the control group .
-CONCLUSIONS	CBT proved to be an effective intervention for improving the clinical states of IBS in young female nursing students .
-
-###24821974
-OBJECTIVE	This study was aimed to examine how well readers of newspapers understand cancer survival rate data , and the effect of this understanding on their behavioral intent .
-METHODS	We recruited 1950 persons who were 20 years old or older registered with a market research company .
-METHODS	Participants were randomly divided into 10 groups ; 9 were assigned one of nine newspaper articles , and the remaining group was assigned the excerpt of the official Association of Clinical Cancer Centers web pages .
-METHODS	The primary outcome was the proportion of respondents with ` sufficient understanding ' , who gave 70 % or more correct answers on a 10-item knowledge question .
-RESULTS	The proportion of participants with sufficient understanding varied across the groups ( range : 0.8-22 .1 % , overall , P < 0.001 ) .
-RESULTS	Only around 15 % of participants answered that they would consider other hospitals in a scenario where the only hospital in the participants ' area had a 5-year survival of 5 % or less , and answers did not significantly vary between groups ( range : 11.1-21 .0 % , overall P = 0.77 ) .
-CONCLUSIONS	The level of understanding of cancer survival rate varied by variation in media reporting .
-CONCLUSIONS	However , the effect of behavioral intent on hospital choice did not differ between articles .
-BACKGROUND	UMIN CTR UMIN000004885 .
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-###24506479
-BACKGROUND	Color affects emotions , feelings , and behaviors .
-BACKGROUND	We hypothesized that color used in self-monitoring of blood glucose ( SMBG ) is helpful for patients to recognize and act on their glucose levels to improve glycemic control .
-BACKGROUND	Here , two color-indication methods , color record ( CR ) and color display ( CD ) , were independently compared for their effects on glycemic control in less frequently insulin-treated type 2 diabetes .
-METHODS	One hundred twenty outpatients were randomly allocated to four groups with 22 factorial design : CR or non-CR and CD or non-CD .
-METHODS	Blood glucose levels were recorded in red or blue pencil in the CR arm , and a red or blue indicator light on the SMBG meter was lit in the CD arm , under hyperglycemia or hypoglycemia , respectively .
-METHODS	The primary end point was difference in glycated hemoglobin ( HbA1c ) reduction in 24 weeks .
-METHODS	Secondary end points were self-management performance change and psychological state change .
-RESULTS	HbA1c levels at 24 weeks were significantly decreased in the CR arm by -0.28 % but were increased by 0.03 % in the non-CR arm ( P = 0.044 ) .
-RESULTS	In addition , diet and exercise scores were significantly improved in the CR arm compared with the non-CR arm .
-RESULTS	The exercise score showed significant improvement in the CD arm compared with the non-CD arm but without a significant difference in HbA1c reduction .
-RESULTS	Changes in psychological states were not altered between the arms .
-CONCLUSIONS	CR has a favorable effect on self-management performance without any influence on psychological stress , resulting in improved glycemic control in type 2 diabetes patients using less frequent insulin injection .
-CONCLUSIONS	Thus , active but not passive usage of color-indication methods by patients is important in successful SMBG .
-
-###25635593
-BACKGROUND	During spinal anesthesia for cesarean delivery , phenylephrine can cause reflexive decreases in maternal heart rate and cardiac output .
-BACKGROUND	Norepinephrine has weak - adrenergic receptor agonist activity in addition to potent - adrenergic receptor activity and therefore may be suitable for maintaining blood pressure with less negative effects on heart rate and cardiac output compared with phenylephrine .
-METHODS	In a randomized , double-blinded study , 104 healthy patients having cesarean delivery under spinal anesthesia were randomized to have systolic blood pressure maintained with a computer-controlled infusion of norepinephrine 5 g/ml or phenylephrine 100 g/ml .
-METHODS	The primary outcome compared was cardiac output .
-METHODS	Blood pressure heart rate and neonatal outcome were also compared .
-RESULTS	Normalized cardiac output 5 min after induction was greater in the norepinephrine group versus the phenylephrine group ( median 102.7 % [ interquartile range , 94.3 to 116.7 % ] versus 93.8 % [ 85.0 to 103.1 % ] , P = 0.004 , median difference 9.8 % , 95 % CI of difference between medians 2.8 to 16.1 % ) .
-RESULTS	From induction until uterine incision , for norepinephrine versus phenylephrine , systolic blood pressure and stroke volume were similar , heart rate and cardiac output were greater , systemic vascular resistance was lower , and the incidence of bradycardia was smaller .
-RESULTS	Neonatal outcome was similar between groups .
-CONCLUSIONS	When given by computer-controlled infusion during spinal anesthesia for cesarean delivery , norepinephrine was effective for maintaining blood pressure and was associated with greater heart rate and cardiac output compared with phenylephrine .
-CONCLUSIONS	Further work would be of interest to confirm the safety and efficacy of norepinephrine as a vasopressor in obstetric patients .
-
-###24627921
-OBJECTIVE	Recent studies indicate that perioperative fluid restriction leads to better preserved clinical data as well as reduced complication rates .
-OBJECTIVE	This study aimed to determine the probable mechanism of fluid restriction influence on the complication rate of patients undergoing gastrointestinal surgery for malignancy .
-METHODS	Patients ( n = 174 ) undergoing restricted fluid regimen ( R group ) or standard fluid regimen ( S group ) were included in this prospective , randomized trial over 16 months .
-METHODS	Fluid distribution was determined by Bioelectrical Impedance Analyzer ( BIA ) and the difference between two groups was compared regarding complications and the relationship between complications and fluid distribution changes .
-RESULTS	The restricted intravenous fluid regimen significantly reduced perioperative intravenous fluid volume .
-RESULTS	Weight gained in S group and was not significantly changed in R group after surgery , especially in POD2 ( media ; R vs. S ; 61.17 vs. 65.40 kg , p = 0.017 ) .
-RESULTS	The number of patients with postoperative complications was reduced in R group compared with in S group ( 34.5 % vs. 47.8 % , p = 0.076 ) .
-RESULTS	Systemic complications were significantly reduced in R group ( t = -5.895 , p = 0.000 ) .
-RESULTS	Patients with complications had an average of 1.6 complications in R group vs. 2.0 in S group ( t = -1.345 , p = 0.183 ) .
-RESULTS	The multivariate analysis suggested that perioperative fluid distribution changes were associated with the development of postoperative complications .
-CONCLUSIONS	Perioperative fluid restriction could effect on fluid distribution and reduce tissue and cellular edema , and further , could reduce postoperative complication rates .
-
-###24622804
-BACKGROUND	Vitamin D deficiency is associated with obesity ; whether repletion supports weight loss and changes obesity-related biomarkers is unknown .
-OBJECTIVE	We compared 12 mo of vitamin D3 supplementation with placebo on weight , body composition , insulin , and C-reactive protein ( CRP ) in postmenopausal women in a weight-loss intervention .
-METHODS	A total of 218 overweight/obese women ( 50-75 y of age ) with serum 25-hydroxyvitamin D [ 25 ( OH ) D ] 10 ng/mL but < 32 ng/mL were randomly assigned to weight loss + 2000 IU oral vitamin D3/d or weight loss + daily placebo .
-METHODS	The weight-loss intervention included a reduced-calorie diet ( 10 % weight loss goal ) and 225 min/wk of moderate-to-vigorous aerobic activity .
-METHODS	Mean 12-mo changes in weight , body composition , serum insulin , CRP , and 25 ( OH ) D were compared between groups ( intent-to-treat ) by using generalized estimating equations .
-RESULTS	A total of 86 % of participants completed the 12-mo measurements .
-RESULTS	The mean ( 95 % CI ) change in 25 ( OH ) D was 13.6 ( 11.6 , 15.4 ) ng/mL in the vitamin D3 arm compared with -1.3 ( -2.6 , -0.3 ) ng/mL in the placebo arm ( P < 0.0001 ) .
-RESULTS	Changes in weight [ -7.1 ( -8.7 , -5.7 ) compared with -7.4 ( -8.1 , -5.4 ) kg ] , body mass index ( in kg/m ( 2 ) : both -2.8 ) , waist circumference [ -4.9 ( -6.7 , -2.9 ) compared with -4.5 ( -5.6 , -2.6 ) cm ] , percentage body fat [ -4.1 ( -4.9 , -2.9 ) compared with -3.5 ( -4.5 , -2.5 ) ] , trunk fat [ -4.1 ( -4.7 , -3.0 ) compared with -3.7 ( -4.3 , -2.9 ) kg ] , insulin [ -2.5 ( -3.4 , -1.7 ) compared with -2.4 ( -3.3 , -1.4 ) U/mL ] , and CRP [ -0.9 ( -1.2 , -0.6 ) compared with -0.79 ( -0.9 , -0.4 ) mg/L ] [ corrected ] were similar between groups ( all P > 0.05 ) .
-RESULTS	Compared with women who achieved 25 ( OH ) D < 32 ng/mL , women randomly assigned to vitamin D who became replete ( ie , 25 ( OH ) D 32 ng/mL ) lost more weight [ -8.8 ( -11.1 , -6.9 ) compared with -5.6 ( -7.2 , -5.0 ) kg ; P = 0.05 ] , waist circumference [ -6.6 ( -9.3 , -4.3 ) compared with -2.5 ( -4.6 , -2.0 ) cm ; P = 0.02 ] , and percentage body fat [ -4.7 ( -6.1 , -3.5 ) compared with -2.6 ( -3.9 , -2.2 ) ; P = 0.04 ] .
-RESULTS	Among women with complete pill counts ( 97 % adherence ) , the mean decrease in CRP was 1.18 mg/mL ( 46 % ) in the vitamin D arm compared with 0.46 mg/mL ( 25 % ) in the placebo arm ( P = 0.03 ) .
-CONCLUSIONS	Vitamin D3 supplementation during weight loss did not increase weight loss or associated factors compared with placebo ; however , women who became replete experienced greater improvements .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01240213 .
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-###25643851
-OBJECTIVE	To determine the initial efficacy of a mailed screening and brief intervention to reduce at-risk drinking in persons aged 50 and older .
-METHODS	Pilot randomized controlled trial .
-METHODS	University of California at Los Angeles Department of Medicine Community Offices and Primary Care Network .
-METHODS	Individuals aged 50 and older who were identified as at-risk drinkers according to the Comorbidity Alcohol Risk Evaluation Tool ( CARET ) ( N = 86 ) .
-METHODS	Participants were assigned randomly to receive personalized mailed feedback outlining their specific risks associated with alcohol use , an educational booklet on alcohol and aging , and the National Institutes of Health Rethinking Drinking : Alcohol and Your Health booklet ( intervention group ) or nothing ( control group ) .
-METHODS	Alcohol-related assessments at baseline and 3 months ; CARET-assessed at-risk drinking , number of risks , and types of risks .
-RESULTS	At 3 months , fewer intervention group participants than controls were at-risk drinkers ( 66 % vs 88 % ) , binge drinking ( 45 % vs 68 % ) , using alcohol with a medical or psychiatric condition ( 3 % vs 17 % ) , or having symptoms of such a condition ( 29 % vs 49 % ) .
-CONCLUSIONS	A brief mailed intervention may be an effective approach to intervening with at-risk drinkers aged 50 and older .
-
-###24928218
-BACKGROUND	Tobacco cessation medication adherence is one of the few factors shown to improve smoking cessation rates among methadone-maintained smokers , but interventions to improve adherence to smoking cessation medications have not yet been tested among methadone treatment patients .
-BACKGROUND	Methadone clinic-based , directly observed therapy ( DOT ) programs for HIV and tuberculosis improve adherence and clinical outcomes , but have not been evaluated for smoking cessation .
-BACKGROUND	We describe a randomized controlled trial to evaluate whether a methadone clinic-based , directly observed varenicline therapy program increases adherence and tobacco abstinence among opioid-dependent drug users receiving methadone treatment .
-METHODS	We plan to enroll 100 methadone-maintained smokers and randomize them to directly observed varenicline dispensed with daily methadone doses or treatment as usual ( self-administered varenicline ) for 12weeks .
-METHODS	Our outcome measures are : 1 ) pill count adherence and 2 ) carbon monoxide-verified tobacco abstinence .
-METHODS	We will assess differences in adherence and abstinence between the two treatment arms using repeated measures models .
-CONCLUSIONS	This trial will allow for rigorous evaluation of the efficacy of methadone clinic-based , directly observed varenicline for improving adherence and smoking cessation outcomes .
-CONCLUSIONS	This detailed description of trial methodology can serve as a template for the development of future DOT programs and can guide protocols for studies among opioid-dependent smokers receiving methadone treatment .
-BACKGROUND	clinicaltrials.gov NCT01378858 .
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-###26085529
-BACKGROUND	Preoperative patient education is an important part of the informed consent process , and a perceived lack of information can lower patient satisfaction .
-BACKGROUND	We sought to evaluate the effect of a web-based multimedia patient education tool on the perioperative experience of patients undergoing first-time knee arthroscopy for a meniscal tear .
-METHODS	Adult patients undergoing knee arthroscopy for the first time for a primary diagnosis of a meniscal tear were consecutively enrolled into the study from January 2014 through June 2014 .
-METHODS	Patients were equally randomized to a control group , who received standard preoperative counseling , or the intervention group , who completed a twenty-minute web-based multimedia tutorial in addition to standard counseling .
-METHODS	The web-based tutorial covered relevant anatomy , pathology , and general perioperative instructions , and it was completed prior to the preoperative visit .
-METHODS	Patients completed surveys that evaluated their preparedness for surgery and knowledge recall at the preoperative visit , on the day of surgery , and after the first postoperative visit .
-RESULTS	Sixty-four patients were enrolled , and fifty-five patients ( 86 % ; twenty-nine in the control group and twenty-six in the intervention group ) with complete data sets were included in the analysis .
-RESULTS	Preoperatively , the intervention group felt significantly more informed about the surgery and more clearly understood the risks and benefits of , and alternatives to , the surgery ( all p < 0.001 ) .
-RESULTS	Postoperatively , the intervention group reported being significantly more satisfied with the perioperative education that they had received and felt more informed about their surgery and rehabilitation ( p 0.05 ) .
-RESULTS	Patients in the intervention group were significantly more likely to correctly answer questions regarding their surgical details at the first postoperative visit ( p 0.03 ) .
-CONCLUSIONS	Patients who completed the web-based tutorial had improved preoperative knowledge and preparedness as well as enhanced postoperative knowledge recall regarding their surgical procedure .
-CONCLUSIONS	The tutorial received high user satisfaction scores with low user burden scores and was an effective tool for enhancing the patients ' perioperative experience .
-
-###26026615
-OBJECTIVE	Postmenopausal women have substantial concerns about weight gain when quitting smoking , which may contribute smoking relapse .
-OBJECTIVE	There is a need for smoking cessation and weight gain prevention programs effective in this population .
-METHODS	Two formats of a smoking cessation/weight gain prevention follow-up intervention in postmenopausal weight concerned women were compared : a minimally-tailored group format and a highly tailored , multidisciplinary individual format .
-METHODS	Effects on sustained abstinence and postcessation weight gain were assessed .
-METHODS	Postmenopausal smokers received 6 sessions of behavioral counseling over a 2-week period , 8weeks of the nicotine transdermal patch , and subsequent random assignment to receive follow-up relapse prevention sessions at 1 , 3 , 8 , and 16weeks postcessation in either group or individual format .
-RESULTS	The sample ( N = 98 ) was 67 % Caucasian and 33 % African-American .
-RESULTS	Age : m = 52.3 ( 7.8 ) years , follicle stimulating hormone : m = 42.6 ( 25.7 ) , body mass index ( BMI ) : m = 27.4 ( 6.2 ) , daily smoking rate : m = 20.3 ( 11.5 ) , for m = 29.4 ( 10.7 ) years , Fagerstrm Test for Nicotine Dependence ( FTND ) : m = 6.4 ( 2.1 ) , and carbon monoxide : m = 23.8 ( 13.0 ) ppm .
-RESULTS	Abstinence rates in the group condition were significantly higher at 8weeks posttreatment .
-RESULTS	Group format significantly predicted abstinence rates at 8 and 16weeks posttreatment , even while controlling for age , race , BMI , CPD , years smoking , FTND , and weight concern .
-RESULTS	Weight concern predicted postcessation weight gain at 8 and 16weeks posttreatment .
-CONCLUSIONS	Results indicate that smoking cessation programs for postmenopausal women may best be delivered in a group format and that postcessation weight concerns be dealt with prior to a quit date .
-
-###25497262
-BACKGROUND	Prevailing recommendations call for restricting intake of dietary cholesterol and eggs for those at risk of heart disease , despite accumulating evidence challenging this association .
-BACKGROUND	Our prior studies showed no short-term adverse effects of daily egg intake on cardiac risk factors in at-risk adults .
-OBJECTIVE	We conducted this study to determine effects of daily egg consumption in adults with established coronary artery disease ( CAD ) .
-METHODS	Randomized , controlled , single-blind , crossover trial of 32 adults ( mean age , 67 years ; 6 women , 26 men ) with CAD assigned to 1 of 6 possible sequence permutations of 3 different treatments ( breakfast with 2 eggs , breakfast with cup Egg Beaters , ConAgra Foods , St. Louis , MO , or a high-carbohydrate breakfast part of an ad libitum diet ) for 6 weeks , with 4-week washout periods .
-METHODS	The primary outcome measure was endothelial function measured as flow-mediated dilatation .
-RESULTS	Compared with the control breakfast ( ie , high-carbohydrate breakfast ) , daily consumption of eggs showed no adverse effects on flow-mediated dilatation ( 7.2 % 2.9 % vs 7.5 % 2.9 % , P = .33 ) , lipids ( total cholesterol : 158.3 28.6 mg/dL vs 156.2 27.4 mg/dL , P = .49 ) , blood pressure ( systolic blood pressure : 132.8 14.1 mm Hg or vs 135.5 14.9 mm Hg , P = .52 ; diastolic blood pressure : 77.2 6.1 mm Hg vs 76.7 6.9 mm Hg , P = .86 ) , or body weight ( 90.8 17.5 kg vs 91.8 17.1 kg , P = .92 ) .
-RESULTS	No outcomes differed ( P > .05 ) between eggs and Egg Beaters .
-CONCLUSIONS	We found no evidence of adverse effects of daily egg ingestion on any cardiac risk factors in adults with CAD over a span of 6 weeks .
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-###25437725
-OBJECTIVE	To evaluate the effectiveness of a professional one-to-one antenatal breastfeeding support and education intervention on the exclusivity and duration of breastfeeding .
-METHODS	A total of 469 primiparous women who attended the antenatal clinics of two geographically distributed public hospitals in Hong Kong were randomized to receive either standard antenatal care or a one-to-one antenatal breastfeeding support and education session .
-METHODS	The primary outcome was the prevalence of exclusive breastfeeding at 6 weeks postpartum .
-METHODS	Secondary outcomes were the prevalence of exclusive breastfeeding at 3 and 6 months postpartum as well as the overall duration of any and exclusive breastfeeding across the first 6 months postpartum .
-RESULTS	The exclusive breastfeeding rate in the intervention group was 37.8 % at 6 weeks postpartum compared with 36.4 % in the standard care group ( P = .77 ; 95 % confidence interval [ CI ] -0.08 to 0.11 ) .
-RESULTS	There were no significant differences between the two treatment groups in exclusive breastfeeding rates at 3 and 6 months or in the overall duration of any ( hazard ratio [ HR ] 1.11 , 95 % CI 0.88-1 .40 ] or exclusive breastfeeding ( HR 0.96 , 95 % CI 0.79-1 .17 ) .
-RESULTS	The study had a least 80 % power to detect a 50 % increase in the rate of exclusive breastfeeding at 6 weeks postpartum .
-CONCLUSIONS	In a setting with a high breastfeeding initiation rate , one-to-one antenatal breastfeeding support and education did not increase the exclusivity or duration of breastfeeding .
-BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT01648114 .
-
-###25061127
-BACKGROUND	Individuals on hemodialysis have low physical function and activity levels .
-BACKGROUND	Clinical trials have shown improvements in these parameters with exercise programming .
-BACKGROUND	Pedometers have not been extensively evaluated in individuals on hemodialysis .
-BACKGROUND	This randomized clinical trial compared the effects of intradialytic cycling versus a pedometer program on physical function , physical activity and quality of life .
-METHODS	Sixty patients were randomly assigned to two study groups .
-METHODS	The ergometer group cycled during each hemodialysis session for 24 weeks .
-METHODS	Pedometer participants followed a home-based walking program for 24 weeks .
-METHODS	The primary outcome was aerobic capacity [ VO2peak and 6-minute walk ( 6MW ) test ] .
-METHODS	Secondary outcomes included lower extremity strength [ sit-to-stand ( SS ) test ] , flexibility [ sit-and-reach ( SR ) test ] , physical activity ( accelerometer ) and health-related quality of life .
-METHODS	Measurements were collected at baseline and at 12 and 24 weeks .
-RESULTS	At 12 and 24 weeks , there was no significant change in the VO2peak or 6MW test between or within study groups .
-RESULTS	SS testing in the ergometer group improved from 10.2 ( SD 3.4 ) to 11.4 ( SD 2.5 ) cycles from baseline to 24 weeks ( P < 0.005 ) .
-RESULTS	Similarly , in the pedometer group , SS cycles improved from 10.1 ( SD 3.3 ) to 12.2 ( SD 3.5 ) ( P < 0.005 ) .
-RESULTS	The SR test also significantly improved over time in both the study groups .
-RESULTS	No significant changes were noted for other secondary outcomes .
-CONCLUSIONS	Both intradialytic cycling and pedometer programming improved aspects of physical function .
-CONCLUSIONS	Neither intervention had a significant effect on aerobic capacity .
-CONCLUSIONS	No significant differences in any outcomes were identified between interventions groups .
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-###24693959
-BACKGROUND	Spondylolisthesis is the major cause of refractory low back pain .
-BACKGROUND	There are many studies of the surgical treatment of spondylolisthesis , but few of conservative treatments .
-BACKGROUND	There is also no optimal conservative treatment protocol , however , low back pain caused by low-grade spondylolisthesis is controlled with non-surgical pain management .
-BACKGROUND	Acupuncture has become a useful method for treating low back pain , but there has not been any study of its efficacy in relation to spondylolisthesis .
-BACKGROUND	This study was designed to establish the feasibility of a randomized controlled trial and the safety of acupuncture for low back pain due to low-grade spondylolisthesis .
-METHODS	The study is a randomized controlled pilot clinical trial of five weeks duration .
-METHODS	Fourteen patients will be recruited and randomly allocated to two groups : an acupuncture plus interlaminar epidural steroid injection group ( experimental group ) , and an interlaminar epidural steroid injection group ( control group ) .
-METHODS	All patients will be administered an interlaminar epidural steroid injection once a week for three weeks ( three injections in total ) , but only the experimental group will receive additional treatment with three acupuncture sessions a week for three weeks ( nine acupuncture sessions in total ) .
-METHODS	The primary outcome will be measured by the visual analogue scale ( VAS ) .
-METHODS	Our primary end point is three-week VAS .
-METHODS	The secondary outcome will be measured using the PainVision system , the short-form McGill Pain Questionnaire , and the Oswestry Disability Index .
-METHODS	Assessments will be made at baseline and at one , three and five weeks thereafter ( that is , the five-week assessment will be made two weeks after treatment cessation ) .
-CONCLUSIONS	This randomized controlled pilot trial will inform the design of a further full-scale trial .
-CONCLUSIONS	The outcomes will provide some resources for incorporating acupuncture into existing pain management methods such as interlaminar epidural steroid injection in low-grade spondylolisthesis .
-BACKGROUND	This trial is registered with the US National Institutes of Health Clinical Trials registry : NCT01909284 .
-
-###25222672
-BACKGROUND	Opioid-induced respiratory depression is potentially lethal .
-BACKGROUND	GAL021 is a calcium-activated potassium ( BKCa ) channel blocker that causes reversal of opioid-induced respiratory depression in animals due to a stimulatory effect on ventilation at the carotid bodies .
-BACKGROUND	To assess in humans whether GAL021 stimulates breathing in established opioid-induced respiratory depression and to evaluate its safety , a proof-of-concept double-blind randomized controlled crossover study on isohypercapnic ventilation ( study 1 ) and subsequent double-blind exploratory study on poikilocapnic ventilation and nonrespiratory end points ( study 2 ) was performed .
-METHODS	In study 1 , intravenous low - and high-dose GAL021 and placebo were administrated on top of low - and high-dose alfentanil-induced respiratory depression in 12 healthy male volunteers on two separate occasions .
-METHODS	In study 2 , the effect of GAL021/placebo on poikilocapnic ventilation , analgesia , and sedation were explored in eight male volunteers .
-METHODS	Data are mean difference between GAL021 and placebo ( 95 % CI ) .
-RESULTS	Study 1 : Under isohypercapnic conditions , a separation between GAL021 and placebo on minute ventilation was observed by 6.1 ( 3.6 to 8.6 ) l/min ( P < 0.01 ) and 3.6 ( 1.5 to 5.7 ) l/min ( P < 0.01 ) at low-dose alfentanil plus high-dose GAL021 and high-dose-alfentanil plus high-dose GAL021 , respectively .
-RESULTS	Study 2 : Similar observations were made on poikilocapnic ventilation and arterial pCO2 .
-RESULTS	GAL021 had no effect on alfentanil-induced sedation , antinociception and no safety issues or hemodynamic effects became apparent .
-CONCLUSIONS	GAL021 produces respiratory stimulatory effects during opioid-induced respiratory depression with containment of opioid-analgesia and without any further increase of sedation .
-CONCLUSIONS	Further studies are needed to confirm these preliminary data .
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-###25526101
-OBJECTIVE	To compare the clinical outcomes and the rate of complications of 27-gauge transconjunctival nonvitrectomizing vitreous surgery ( NVS ) and of 25-gauge transconjunctival sutureless vitrectomy surgery for idiopathic epiretinal membrane removal .
-METHODS	In this prospective randomized study , 83 phakic eyes of 83 consecutive patients with an idiopathic epiretinal membrane were randomized to receive 27-gauge NVS ( NVS-group ) or 25-gauge vitrectomy ( Standard-group ) .
-METHODS	Main outcome measures were best-corrected visual acuity , central retinal thickness , nuclear density units ' changes , and rate of complications .
-RESULTS	Thirty-nine eyes of the Standard-group and 40 of the NVS-group were considered in final analysis .
-RESULTS	Mean best-corrected visual acuity improved significantly in both groups , with a significant better result at 12 months in NVS-group ( P = 0.039 ; t-test ) .
-RESULTS	Central retinal thickness decreased significantly in both groups ( P < 0.001 , Tukey test ) , without significant difference between the two groups at any time point .
-RESULTS	At 12 months , nuclear density increased significantly in the Standard-group ( analysis of variance , P < 0.001 ) , and it did not change in the NVS-group ( analysis of variance , P = 0.537 ) .
-RESULTS	Epiretinal membrane recurred in 5.1 % of eyes in the Standard-group and in 7.5 % of eyes in the NVS-group ( Fisher 's exact test , P = 1.000 ) .
-CONCLUSIONS	The 27-gauge NVS is an effective surgical procedure in eyes with epiretinal membrane and it induces less progression of nuclear sclerosis than 25-gauge vitrectomy .
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-###25300916
-BACKGROUND	National data suggest a higher prevalence of obesity among boys .
-BACKGROUND	One possible cause could be the food choices made by parents on behalf of their children .
-OBJECTIVE	This study sought to determine whether and how mothers ' food choices for their children differ by child gender and to understand the drivers of these differences .
-METHODS	Data were analyzed from a randomized controlled trial conducted using a virtual reality-based buffet restaurant .
-METHODS	Overweight mothers filled out questionnaires and received an information module .
-METHODS	They were then immersed in a virtual buffet restaurant to select a lunch for their 4 - to 5-year-old child .
-RESULTS	Of the 221 overweight mothers recruited , 55 % identified their daughters as the child for whom they would be choosing the food .
-RESULTS	The caloric content of boys ' meals was 43 calories higher than girls ' ( p = .015 ) .
-RESULTS	This difference was due to extra calories from the less healthy food category ( p = .04 ) .
-RESULTS	Multivariate analyses identified more predictors of calorie choices for daughters ' than sons ' meals .
-RESULTS	Predictors of calories chosen for girls included : having both biological parents overweight ( = 0.26 ; p = .003 ) , mother 's weight ( = 0.17 ; p = .05 ) , mother 's education ( = -0.28 ; p = .001 ) , her restriction of her child 's food intake ( = -0.20 ; p = .02 ) , and her beliefs about the importance of genetics in causing obesity ( = 0.19 ; p = .03 ) .
-RESULTS	Mother 's weight was the sole predictor of boys ' meal calories ( = 0.20 ; p = .04 ) .
-CONCLUSIONS	Differences in dietary choices made for young girls and boys may contribute to lifelong gender differences in eating patterns .
-CONCLUSIONS	A better understanding of differences in feeding choices made for girls versus boys could improve the design of childhood obesity prevention interventions .
-
-###25592552
-OBJECTIVE	We evaluated the ability of 23 genetic variants to provide prognostic information in patients enrolled in the Genetic Substudy of the Surgical Treatment for Ischemic Heart Failure ( STICH ) trials .
-METHODS	Patients assigned to STICH Hypothesis 1 were randomized to medical therapy with or without coronary artery bypass grafting ( CABG ) .
-METHODS	Those assigned to STICH Hypothesis 2 were randomized to CABG or CABG with left ventricular reconstruction .
-RESULTS	In patients assigned to STICH Hypothesis 2 ( n = 714 ) , no genetic variant met the prespecified Bonferroni-adjusted threshold for statistical significance ( p < 0.002 ) ; however , several variants met nominal prognostic significance : variants in the 2-adrenergic receptor gene ( 2-AR Gln27Glu ) and in the A1-adenosine receptor gene ( A1-717 T/G ) were associated with an increased risk of a subject dying or being hospitalized for a cardiac problem ( p = 0.027 and 0.031 , respectively ) .
-RESULTS	These relationships remained nominally significant even after multivariable adjustment for prognostic clinical variables .
-RESULTS	However , none of the 23 genetic variants influenced all-cause mortality or the combination of death or cardiovascular hospitalization in the STICH Hypothesis 1 population ( n = 532 ) by either univariate or multivariable analysis .
-CONCLUSIONS	We were unable to identify the predictive genotypes in optimally treated patients in these two ischemic heart failure populations .
-
-###24585202
-OBJECTIVE	In rodent models of diabetes , treatment with sodium glucose co-transporter 2 ( SGLT2 ) inhibitors improves beta cell function .
-OBJECTIVE	This analysis assessed the effects of the SGLT2 inhibitor , canagliflozin , on model-based measures of beta cell function in patients with type 2 diabetes .
-METHODS	Data from three Phase 3 studies were analysed , in which : ( Study 1 ) canagliflozin 100 and 300 mg were compared with placebo as monotherapy for 26 weeks ; ( Study 2 ) canagliflozin 100 and 300 mg were compared with placebo as add-on to metformin + sulfonylurea for 26 weeks ; or ( Study 3 ) canagliflozin 300 mg was compared with sitagliptin 100 mg as add-on to metformin + sulfonylurea for 52 weeks .
-METHODS	In each study , a subset of patients was given mixed-meal tolerance tests at baseline and study endpoint , and model-based beta cell function parameters were calculated from plasma glucose and C-peptide .
-RESULTS	In Studies 1 and 2 , both canagliflozin doses increased beta cell glucose sensitivity compared with placebo .
-RESULTS	Placebo-subtracted least squares mean ( LSM ) ( SEM ) changes were 23 ( 9 ) and 18 ( 9 ) pmol min ( -1 ) m ( -2 ) ( mmol/l ) ( -1 ) with canagliflozin 100 and 300 mg , respectively ( p < 0.002 , Study 1 ) , and 16 ( 8 ) and 10 ( 9 ) pmol min ( -1 ) m ( -2 ) ( mmol/l ) ( -1 ) ( p < 0.02 , Study 2 ) .
-RESULTS	In Study 3 , beta cell glucose sensitivity was minimally affected , but the insulin secretion rate at 9 mmol/l glucose increased to similar degrees from baseline with canagliflozin and sitagliptin [ LSM ( SEM ) changes 38 ( 8 ) and 28 ( 9 ) pmol min ( -1 ) m ( -2 ) , respectively ; p < 0.05 for both ] .
-CONCLUSIONS	Treatment with canagliflozin for 6 to 12 months improved model-based measures of beta cell function in three separate Phase 3 studies .
-BACKGROUND	Clinicaltrials.gov NCT01081834 ( Study 1 ) ; NCT01106625 ( Study 2 ) ; NCT01137812 ( Study 3 ) .
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-###24806568
-OBJECTIVE	To examine whether a Web-based cardiovascular health promotion program was associated with changes in self-reported behaviors , attitudes , and biometric indicators in a population of working adults .
-METHODS	Employees ( n = 210 ) were recruited and randomized into either an Internet-based or control condition .
-METHODS	Participants completed pre - and postintervention self-report assessments on diet , exercise , smoking , and mental health .
-METHODS	Pre - and postintervention biometric screenings were also obtained on blood pressure , heart rate , weight , and hip/waist circumference .
-RESULTS	The intervention was associated with significant improvements in dietary attitudes ( P = 0.003 ; F = 8.83 ) , dietary intentions ( P = 0.031 ; F = 4.72 ) , dietary self-efficacy ( P = 0.015 ; F = 5.97 ) , exercise self-efficacy ( P = 0.002 ; F = 9.51 ) , exercise habits ( P = 0.016 ; F = 5.94 ) , and coping with stress ( P = 0.003 ; F = 8.85 ) and depression ( P = 0.036 ; F = 4.46 ) .
-CONCLUSIONS	The program showed promise for promoting cardiovascular risk reduction behaviors .
-CONCLUSIONS	These results are consistent with similar Web-based interventions .
-
-###25038208
-OBJECTIVE	Minimal hepatic encephalopathy ( MHE ) implies subtle impairment of cognitive functions in the absence of features of overt encephalopathy .
-OBJECTIVE	We aimed to determine the prevalence of MHE in patients with liver cirrhosis and to find out the effect of rifaximin , probiotics , and l-ornithine l-aspartate ( LOLA ) individually in reversal of MHE by comparing it with placebo group .
-METHODS	This study was carried out in two phases .
-METHODS	Phase I included the recruitment of 250 apparently healthy controls and extraction of normative data utilizing three neuropsychometric tests ( NPTs ) and critical flicker frequency ( CFF ) test .
-METHODS	Phase II consisted of screening and recruitment of patients of MHE followed by drugs trial .
-METHODS	A total of 317 cirrhotics were screened ; 111 were excluded and the remaining 206 cirrhotics were screened for MHE using NPTs and/or CFF test .
-METHODS	Of these , 124 patients with MHE were randomized to receive LOLA ( n = 31 ) , rifaximin ( n = 31 ) , probiotics ( n = 32 ) , for 2 months and were compared with patients who were given placebo ( n = 30 ) .
-RESULTS	Out of 206 cirrhotics , 124 ( 60.19 % ) had MHE .
-RESULTS	Among these 124 MHE patients , 87 ( 70.16 % ) patients had CFF < 39Hz , 112 ( 90.32 % ) patients with MHE had two or more abnormal NPTs , and 75 ( 60.48 % ) patients had abnormality on both the CFF values and more than two abnormal NPTs .
-RESULTS	Intention-to-treat analysis showed the number of patients who improved after giving treatment were 67.7 % ( 21/31 ) , 70.9 % ( 22/31 ) , 50 % ( 16/32 ) , and 30 % ( 9/30 ) for LOLA , rifaximin , probiotics , and placebo , respectively .
-RESULTS	CFF scores and improvement in psychometric tests after treatment were significantly higher ( P < 0.05 ) for LOLA , rifaximin , and probiotics as compared with placebo group .
-CONCLUSIONS	Prevalence of MHE is high in patients with cirrhosis of liver .
-CONCLUSIONS	Rifaximin , LOLA , and probiotics are better than giving placebo in patients with MHE .
-
-###25398799
-BACKGROUND	Endotoxaemia is widely used as an experimental model to study sepsis under controlled conditions .
-BACKGROUND	Nighttime endotoxaemia induces a more pronounced inflammatory stress response compared to daytime .
-BACKGROUND	Previously , we have shown that melatonin has antioxidative and anti-inflammatory effects in inflammatory response to daytime endotoxaemia .
-BACKGROUND	Herein , we examined the effect of melatonin in response to human nighttime endotoxaemia .
-METHODS	Twelve healthy male volunteers were enrolled in a randomized , placebo-controlled , double-blinded cross-over trial .
-METHODS	Subjects were induced by lipopolysaccharide ( LPS ) endotoxin 0.3 ng/kg body weight intravenously at 24:00 .
-METHODS	One hour prior to induction of endotoxaemia , an 8-h infusion of melatonin 100 mg or placebo was initiated .
-METHODS	Blood samples were drawn before and 2 , 4 , 6 and 8 h after induction of endotoxaemia and plasma was tested for pro-inflammatory markers ( tumor necrosis factor alpha , TNF - , interleukin-1 , IL-1 , interleukin-1 , IL-6 , and YKL-40 ) , anti-inflammatory markers ( interleukin-1 receptor antagonist , IL-1Ra , interleukin-10 , IL-10 , soluble tumor necrosis factor receptors I and II , sTNF-RI and sTNF-RII ) , marker for oxidative damage ( malondialdehyde ( MDA ) ) and antioxidative enzyme ( ascorbic acid ( AA ) and dehydroascorbic acid ( DHA ) ) .
-RESULTS	Compared to placebo , melatonin did not reduce plasma levels of any of pro- and anti-inflammatory markers and it also failed to influence levels of AA , DHA and MDA .
-CONCLUSIONS	Melatonin has no beneficial effect on inflammation and oxidative damage induced by nighttime endotoxaemia in contrast to daytime endotoxaemia .
-
-###25773757
-BACKGROUND	Patients with cirrhosis resulting from chronic hepatitis C virus ( HCV ) infection are at risk of life-threatening complications , but consistently achieve lower sustained virological response ( SVR ) than patients without cirrhosis , especially if treatment has previously failed .
-BACKGROUND	We assessed the efficacy and safety of the NS5A inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir , with and without ribavirin .
-METHODS	In this multicentre , double-blind trial , between Oct 21 , 2013 , and Oct 30 , 2014 , we enrolled patients with HCV genotype 1 and compensated cirrhosis who had not achieved SVR after successive treatments with pegylated interferon and protease-inhibitor regimens at 20 sites in France .
-METHODS	With a computer-generated randomisation sequence , patients were assigned in a 1:1 ratio to receive placebo matched in appearance to study drugs for 12 weeks followed by once daily combination fixed-dose tablets of 90 mg ledipasvir and 400 mg sofosbuvir plus weight-based ribavirin for 12 weeks , or ledipasvir-sofosbuvir plus placebo once daily for 24 weeks .
-METHODS	The primary endpoint was SVR 12 weeks after the end of treatment ( SVR12 ) , for which 95 % CIs were calculated with the Clopper-Pearson method .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01965535 .
-RESULTS	Of 172 patients screened , 155 entered randomisation , 77 were assigned to receive ledipasvir-sofosbuvir plus ribavirin and 78 ledipasvir-sofosbuvir .
-RESULTS	114 ( 74 % ) were men , 151 ( 97 % ) , were white , 98 ( 63 % ) had HCV genotype 1a , and 145 ( 94 % ) had non-CC IL28B alleles .
-RESULTS	SVR12 rates were 96 % ( 95 % CI 89-99 ) for patients in the ledipasvir-sofosbuvir plus ribavirin group and 97 % ( 91-100 ) in the ledipasvir-sofosbuvir group .
-RESULTS	One patient discontinued treatment because of adverse events while receiving only placebo .
-RESULTS	The most frequent adverse events were asthenia and headache , pruritus , and fatigue .
-CONCLUSIONS	Ledipasvir-sofosbuvir plus ribavirin for 12 weeks and ledipasvir-sofosbuvir for 24 weeks provided similarly high SVR12 rates in previous non-responders with HCV genotype 1 and compensated cirrhosis .
-CONCLUSIONS	The shorter regimen , when given with ribavirin , might , therefore , be useful to treat treatment-experienced patients with cirrhosis if longer-term treatment is not possible .
-BACKGROUND	Gilead Sciences .
-
-###24943829
-BACKGROUND	Psychostimulants and cannabis are two of the three most commonly used illicit drugs by young Australians .
-BACKGROUND	As such , it is important to deliver prevention for these substances to prevent their misuse and to reduce associated harms .
-BACKGROUND	The present study aims to evaluate the feasibility and effectiveness of the universal computer-based Climate Schools : Psychostimulant and Cannabis Module .
-METHODS	A cluster randomised controlled trial was conducted with 1734 Year 10 students ( mean age = 15.44 years ; SD = 0.41 ) from 21 secondary schools in Australia .
-METHODS	Schools were randomised to receive either the six lesson computer-based Climate Schools program or their usual health classes , including drug education , over the year .
-RESULTS	The Climate Schools program was shown to increase knowledge of cannabis and psychostimulants and decrease pro-drug attitudes .
-RESULTS	In the short-term the program was effective in subduing the uptake and plateauing the frequency of ecstasy use , however there were no changes in meth/amphetamine use .
-RESULTS	In addition , females who received the program used cannabis significantly less frequently than students who received drug education as usual .
-RESULTS	Finally , the Climate Schools program was related to decreasing students ' intentions to use meth/amphetamine and ecstasy in the future , however these effects did not last over time .
-CONCLUSIONS	These findings provide support for the use of a harm-minimisation approach and computer technology as an innovative platform for the delivery of prevention education for illicit drugs in schools .
-CONCLUSIONS	The current study indicated that teachers and students enjoyed the program and that it is feasible to extend the successful Climate Schools model to the prevention of other drugs , namely cannabis and psychostimulants .
-BACKGROUND	Australian and New Zealand Clinical Trials Registry ACTRN12613000492752 .
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-###24994476
-OBJECTIVE	Patients with both major depression and personality disorders have a high risk of suicidal behavior .
-OBJECTIVE	Lithium is meant to have anti-suicidal properties in patients with affective disorders .
-OBJECTIVE	The anti-suicidal effect of lithium in patients with affective disorders and comorbid personality disorders has not been investigated yet .
-METHODS	A post-hoc analysis of a subsample of patients with depression and comorbid personality disorder ( PD ) and a recent suicide attempt ( n = 19 ) from the prospective , placebo-controlled lithium intervention study ( N = 167 ) , was conducted .
-RESULTS	Three patients in the lithium group ( n = 8 ) and two patients in the placebo group ( n = 11 ) presented a suicide attempt throughout the course of the study .
-RESULTS	No differences related to suicidal behavior could be detected between the placebo group and the group with lithium intervention .
-CONCLUSIONS	On the basis of the small sample size , among patients with comorbid PD , lithium does not seem to have an effect on suicidal behavior in contrast to patients with affective disorders without comorbid PD .
-
-###25236776
-BACKGROUND	Rural Australian adults are continually shown to be insufficiently active with higher prevalence of lifestyle-related diseases associated with physical inactivity compared to urban adults .
-BACKGROUND	This may , partly , be attributable to the challenges associated with implementing community-based physical activity programs in rural communities .
-BACKGROUND	There is a need for broadly accessible physical activity programs specifically tailored to the unique attributes of rural communities .
-BACKGROUND	The aim of the Rural Environments And Community Health ( REACH ) study is to evaluate the effectiveness of an online-delivered physical activity intervention for increasing regular walking among adults living in rural areas of South Australia .
-METHODS	This is a randomised controlled trial .
-METHODS	The intervention is 12-weeks with a 12-month follow-up .
-METHODS	Participants will be insufficiently active , aged 18 to 70years and randomly assigned to either Control or Intervention group .
-METHODS	Participants receive a pedometer , but only the Intervention group will receive access to the purpose built REACH website where they will report steps taken , affect and ratings of perceived exertion during daily walking .
-METHODS	These variables will be used to establish individualised step goals for increasing walking .
-METHODS	Control participants will receive a paper diary to record their variables and generic incremental step goals.The primary outcome measures are time spent in sedentary , light and moderate-to-vigorous intensity physical activity , measured by accelerometry .
-METHODS	Secondary outcomes include 1 ) health measures ( anthropometric and physiological ) , 2 ) psychological well-being , 3 ) diet quality , and 4 ) correlates of physical activity ( exercise self-efficacy and physical activity environments ) .
-METHODS	Measures will be collected at baseline , post-intervention , 6-month and 12-month follow-up .
-CONCLUSIONS	This protocol describes the implementation of a trial testing the effectiveness of an online resource designed to assist rural Australians to become more physically active .
-CONCLUSIONS	The outcomes of this study will guide the efforts of health promotion professionals by providing evidence for a relatively inexpensive , widely accessible and effective method for increasing physical activity that can be utilized by anyone with access to the internet .
-CONCLUSIONS	Findings may indicate future directions for the implementation of physical activity and other health related interventions in rural communities .
-BACKGROUND	Australian New Zealand Clinical Trials Registry : ACTR12614000927628 ( registered 28 August 2014 ) .
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-###26054119
-OBJECTIVE	To observe the effectiveness of chlortetracycline ( aureomycin ) treatment on vulval white lesions and to explore its possible pathogenesis .
-METHODS	From January 2001 to April 2011 , 194 patients with vulvar non-neoplastic epithelial disorders were divided into three groups according to therapy regimens received , ie , chlortetracycline treatment group ( 72 cases ) , chlortetracycline + beclomethasone treatment group ( 66 cases ) , and beclomethasone treatment group ( 56 cases ) ; their local changes of vulvar lesions were observed and efficacy of these treatment profiles was evaluated after one year .
-RESULTS	Effective rates of chlortetracycline group , chlortetracycline + clobetasol group and clobetasol groups were 86.1 % ( 62/72 ) , 87.9 % ( 58/66 ) , and 62.5 % ( 35/56 ) , respectively .
-RESULTS	There was a significant difference among these three groups ( Hc = 10.7766 , p = 0.0046 ) , the curative rate of clobetasol group was markedly lower than that of the former two groups ( p = 0.0072 and p = 0.0019 ) , but was not statistical significant ( p = 0.6077 ) when compared between the former groups .
-CONCLUSIONS	The occurrence of vulvar non-neoplastic epithelial disorders may be associated with chlamydia and mycoplasma infection , the chlortetracycline is an effective drug for this illness , the mechanism of which might be related to killing pathogens directly and inhibiting inflammatory mediators .
-
-###24999283
-OBJECTIVE	Drug-related emergency department ( ED ) visits have steadily increased , with substance users relying heavily on the ED for medical care .
-OBJECTIVE	The present study aims to identify clinical correlates of problematic drug use that would facilitate identification of ED patients in need of substance use treatment .
-METHODS	Using previously validated tests , 15,224 adult ED patients across 6 academic institutions were prescreened for drug use as part of a large randomized prospective trial .
-METHODS	Data for 3,240 participants who reported drug use in the past 30 days were included .
-METHODS	Self-reported variables related to demographics , substance use , and ED visit were examined to determine their correlative value for problematic drug use .
-RESULTS	Of the 3,240 patients , 2,084 ( 64.3 % ) met criteria for problematic drug use ( Drug Abuse Screening Test score 3 ) .
-RESULTS	Age greater than or equal to 30 years , tobacco smoking , daily or binge alcohol drinking , daily drug use , primary noncannabis drug use , resource-intense ED triage level , and perceived drug-relatedness of ED visit were highly correlated with problematic drug use .
-RESULTS	Among primary cannabis users , correlates of problematic drug use were age younger than 30 years , tobacco smoking , binge drinking , daily drug use , and perceived relatedness of the ED visit to drug use .
-CONCLUSIONS	Clinical correlates of drug use problems may assist the identification of ED patients who would benefit from comprehensive screening , intervention , and referral to treatment .
-CONCLUSIONS	A clinical decision rule is proposed .
-CONCLUSIONS	The correlation between problematic drug use and resource-intense ED triage levels suggests that ED-based efforts to reduce the unmet need for substance use treatment may help decrease overall health care costs .
-
-###25039978
-BACKGROUND	Little is known regarding patient characteristics that influence the speed of reflux oesophagitis ( RO ) healing .
-OBJECTIVE	To investigate patient characteristics that may influence RO healing rates .
-METHODS	A post hoc analysis of clinical trial data for potent acid suppression treatment of RO ( esomeprazole or AZD0865 ) was conducted .
-METHODS	Group A underwent endoscopy at baseline , week 2 and 4 , and group B at baseline , week 4 and 8 .
-METHODS	Group A patients were sub-grouped as ` rapid ' ( healed at 2 weeks ) or unhealed at 2 weeks .
-METHODS	Group B patients were sub-grouped as ` slow ' ( healed at 8 weeks , not at 4 weeks ) or ` refractory ' ( not healed at 8 weeks ) .
-METHODS	Logistic regression analysis was performed only for comparisons within group A.
-RESULTS	At 2 , 4 and 8 weeks , RO had healed in 68 % , 65 % and 61 % of patients unhealed at previous endoscopy , respectively .
-RESULTS	Low-grade [ vs. high-grade ( C or D ) ] RO was the only independent predictor of rapid healing in group A after logistic regression analysis .
-RESULTS	Significantly more rapid healers had low grade RO ( A or B ) at baseline than patients with refractory RO ( 84 % vs. 49 % ; P < 0.001 ) , and significantly more refractory patients had frequent regurgitation at baseline than slow healers ( 80 % vs. 63 % ; P = 0.039 ) .
-CONCLUSIONS	Low - ( vs. high - ) grade RO determines the most rapid benefit from acid suppression .
-CONCLUSIONS	Roughly two-thirds of patients healed with each time increment of potent acid suppression therapy .
-CONCLUSIONS	This suggests that some unhealed patients may still heal with continued therapy and that truly refractory RO is rare .
-CONCLUSIONS	( ClinicalTrials.gov : NCT00206245 ) .
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-###25315937
-OBJECTIVE	To evaluate the effects of levosimendan on hemodynamics and cardiac function in patients with septic shock .
-METHODS	A prospective single-center randomized controlled trial was conducted .
-METHODS	The patients with septic shock admitted to the Department of Critical Care Medicine of the Third Hospital of Hebei Medical University from June 2011 to October 2013 were enrolled .
-METHODS	The patients with septic shock received the conventional treatment according to international guidelines for management of severe sepsis and septic shock .
-METHODS	Thirty-six patients received the examination of echocardiography and left ventricular ejection fraction ( LVEF ) 0.45 after fluid resuscitation were enrolled the study , who were divided into two groups according to random number table , with 18 cases in each group .
-METHODS	After the conventional treatment , the patients in dobutamine group received intravenous injection of 5 g kg min dobutamine for 48 hours immediately after fluid resuscitation , and those in levosimendan group received a 24-hour infusion of 5 g kg min dobutamine followed by a 24-hour infusion of 0.2 g kg min levosimendan .
-METHODS	The hemodynamics and cardiac function were evaluated by pulse indicator continuous cardiac output ( PiCCO ) and ultrasound during treatment .
-RESULTS	Compared with dobutamine group , after the treatment in the levosimendan group , stroke volume index ( SVI ) , cardiac index ( CI ) and left ventricular stroke work index ( LVSWI ) were significantly increased [ SVI ( mL/m ) : 39.8 5.4 vs. 37.5 4.5 , t = -2.762 , P = 0.020 ; CI ( L min m ) : 4.6 0.7 vs. 3.6 0.7 , t = -9.829 , P = 0.000 ; LVSWI ( kg min m ) : 33.7 2.4 vs. 28.2 1.2 , t = -6.307 , P = 0.000 ] , and central venous pressure ( CVP ) , intrathoracic blood volume index ( ITBVI ) and extravascular lung water index ( EVLWI ) were significantly decreased [ CVP ( mmHg , 1 mmHg = 0.133 kPa ) : 8.2 0.9 vs. 12.1 0.8 , t = 3.928 , P = 0.002 ; ITBVI ( mL/m ) : 820 42 vs. 978 69 , t = 9.472 , P = 0.000 ; EVLWI ( mL/kg ) : 6.1 1.6 vs. 8.9 1.7 , t = 4.467 , P = 0.001 ] .
-RESULTS	Cardiac ultrasound showed that compared with dobutamine group , in the levosimendan group , left ventricular end-systolic volume ( LVESI ) and end-diastolic volume ( LVEDI ) were significantly lowered [ LVESI ( mL/m ) : 32.7 9.2 vs. 48.2 13.4 , t = 0.882 , P = 0.000 ; LVEDI ( mL/m ) : 61.7 11.4 vs. 78.6 13.6 , t = 2.453 , P = 0.032 ] , and the LVEF was significantly increased ( 0.463 0.068 vs. 0.383 .085 , t = -2.439 , P = 0.035 ) .
-RESULTS	Levosimendan also could decrease the lactic acid ( mmol/L : 3.4 1.1 vs. 5.2 1.2 , t = 3.346 , P = 0.007 ) , and increase the lactate clearance rate ( mL/min : 73.2 13.5 vs. 47.6 11.8 , t = -4.079 , P = 0.002 ) , 24-hour urinary output ( mL : 2 213.4 354.0 vs. 1 533.8 402.0 , t = 6.342 , P = 0.000 ) and 24-hour cumulative intake ( mL : 5 746.6 420.0 vs. 4 156.7 215.0 , t = 7.126 , P = 0.000 ) .
-RESULTS	There were no significant differences in total volume of norepinephrine , mortality in intensive care unit ( ICU ) and 28-day mortality between two groups .
-CONCLUSIONS	Levosimendan can increase cardiac ejection function , reduce the heart blood and vascular preload , intrathoracic lung water , improve heart function and systemic hemodynamic indexes of patients with septic shock .
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-###25355716
-BACKGROUND	Secreted protein acidic and rich in cysteine ( SPARC ) has been suggested as a new biomarker and therapeutic target in breast cancer , as well as other tumor types .
-METHODS	We evaluated the frequency of SPARC expression among different molecular breast cancer subtypes and its role for therapy response after neoadjuvant chemotherapy .
-METHODS	In this study , pretherapeutic core biopsies of 667 patients from the neoadjuvant GeparTrio trial were evaluated for SPARC expression by immunohistochemistry using a standardized immunoreactive score ( IRS ) .
-RESULTS	An increased SPARC expression ( IRS 6 ) was observed in 26 % of all tumors .
-RESULTS	In triple-negative tumors , SPARC expression was increased in 37 % of tumors , compared with other molecular subtypes ( 23 % HR + / HER2 - , 29 % HR + / HER2 + and 22 % HR - / HER2 + ; P = 0.038 ) .
-RESULTS	Increased SPARC expression was associated with an increased pathological complete response ( pCR ) rate of 27 % , compared with 15 % in tumors with low SPARC expression ( P < 0.001 ) .
-RESULTS	In the triple-negative subgroup , pCR rates were 47 % in tumors with high SPARC expression , compared with 26 % in tumors with low SPARC expression ( P = 0.032 ) .
-RESULTS	In multivariable analysis , SPARC was independently predictive in the overall population ( P = 0.010 ) as well as the triple-negative subgroup ( P = 0.036 ) .
-CONCLUSIONS	SPARC is frequently expressed in breast cancer with triple-negative breast cancer revealing the highest expression rate .
-CONCLUSIONS	High SPARC expression of the primary tumor is associated with a higher chance of achieving a pathological complete remission after TAC or TAC-NX chemotherapy .
-CONCLUSIONS	As SPARC is an albumin-binding protein and might mediate intratumoral accumulation of albumin bound drugs , SPARC should be further evaluated as a predictive marker especially for response to albumin-bound drugs like nab-paclitaxel .
-BACKGROUND	NCT00544765 .
-
-###24273022
-OBJECTIVE	To evaluate health-related quality of life ( HRQOL ) and corticosteroid use in patients with moderate to severely active SLE enrolled in two international , multicentre , randomized controlled trials of epratuzumab ( ALLEVIATE-1 and -2 ) and a long-term extension study ( SL0006 ) .
-METHODS	Ninety ALLEVIATE patients ( 43 % BILAG A , mean BILAG score 13.2 ) were randomized to receive 360 mg/m ( 2 ) ( n = 42 ) or 720 mg/m ( 2 ) ( n = 11 ) epratuzumab or placebo ( n = 37 ) , plus standard of care , in 12-week cycles .
-METHODS	Corticosteroid use , patient and physician global assessments of disease activity ( PtGA and PGA ) and 36-item Medical Outcomes Survey Short Form ( SF-36 ) results were recorded at baseline and every 4 weeks .
-METHODS	Both trials were prematurely discontinued due to a drug supply interruption ; patients followed for 6 months were analysed .
-METHODS	Twenty-nine patients continued in SL0006 , with interim analysis at a median exposure of 120 ( range 13-184 ) weeks .
-RESULTS	At week 12 , proportions of patients with a PGA 20 % above baseline or with a PtGA improvement greater than or equal to the minimum clinically important difference were higher in the epratuzumab arms than the placebo arm .
-RESULTS	PGA and PtGA improvements were sustained but did not reach statistical significance .
-RESULTS	At week 24 , mean cumulative corticosteroid doses with epratuzumab 360 and 720 mg/m ( 2 ) were 1051 and 1973 mg less than placebo ( P = 0.034 and 0.081 , respectively ) .
-RESULTS	At week 48 , SF-36 scores approached or exceeded US age - and gender-matched norms in five domains with the 360 mg/m ( 2 ) treatment .
-RESULTS	Improvements were maintained in SL0006 over 2 years .
-CONCLUSIONS	Epratuzumab treatment produced clinically meaningful and sustained improvements in PGA , PtGA and HRQOL and reductions in corticosteroid doses .
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-###24480909
-OBJECTIVE	In industrialized countries , low back pain ( LBP ) is one of the leading causes for prolonged sick leave , early retirement , and high health care costs .
-OBJECTIVE	Providing the same treatments to all patients is neither effective nor feasible , and may impede patients ' recovery .
-OBJECTIVE	Recent studies have outlined the need for subgroup-specific treatment allocation .
-METHODS	This is a cross-sectional study that used baseline data from consecutively recruited patients participating in a guideline implementation trial regarding LBP in primary care .
-METHODS	Classification variables were employment status , age , pain intensity , functional capacity ( HFAQ ) , depression ( CES-D ) , belief that activity causes pain ( FABQ subscale ) , 2 scales of the SF-36 ( general health , vitality ) , and days in pain per year .
-METHODS	We performed k-means cluster analyses and split-half cross-validation .
-METHODS	Subsequently , we investigated whether the resulting groups incurred different direct and indirect costs during a 6-month period before the index consultation .
-RESULTS	A 4-cluster solution showed good statistical quality criteria , even after split-half cross-validation .
-RESULTS	`` Elderly patients adapted to pain '' ( cluster 1 ) and `` younger patients with acute pain '' ( cluster 4 ) accounted for 55 % of all patients .
-RESULTS	Cluster validation showed the lowest direct and indirect costs in these groups .
-RESULTS	About 72 % of total costs per patient referred to clusters 2 and 3 ( `` patients with chronic severe pain with comorbid depression '' and `` younger patients with subacute pain and emotional distress '' ) .
-CONCLUSIONS	Our study adds substantially to the knowledge of LBP-related case-mix in primary care .
-CONCLUSIONS	Information on differential health care needs may be inferred from our study , enabling decision makers to allocate resources more appropriately and to reduce costs .
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-###25694008
-BACKGROUND	Erectile dysfunction ( ED ) has been shown to be associated with a number of physical conditions and affects not only physical but also psychosocial health .
-BACKGROUND	Currently oral , on-demand phosphodiesterase type 5 inhibitors ( PDE5i ) are preferred first line treatment .
-BACKGROUND	Though effective , these drugs have limitations and are associated with significant non-compliance , side effects and do not reverse the underlying pathology .
-BACKGROUND	Non-invasive low intensity shockwave therapy ( LISWT ) has been shown to significantly improve erectile function in men previously PDE5i dependent .
-BACKGROUND	We describe our experience and results with this therapy in an Indian population of men with ED .
-BACKGROUND	This study assessed the efficacy of low intensity extracorporeal shockwave therapy ( LI-ESWT ) on Indian men with organic ED who had previously responded to PDE5i .
-METHODS	All the patients underwent a 1 month PDE5i washout period .
-METHODS	Men were randomized to receive either 12 sessions of LI-ESWT ( n = 95 ) or placebo/sham therapy ( n = 40 ) .
-METHODS	Before the first treatment , erectile function and penile hemodynamics were assessed to substantiate a vascular etiology for the ED .
-METHODS	Outcomes were assessed using Erection Hardness Score ( EHS ) , International Index of Erectile Function-Erectile Function Domain ( IIEF-EF domain ) and Clinical Global Impression of Change ( CGIC ) scores at 1 , 3 , 6 , 9 and 12 months post-treatment .
-RESULTS	We found a significant increase in the EHS and IIEF-EF Domain scores from visit 1 to follow up 5 ( 12 months ) in the treated group compared to the placebo group .
-RESULTS	By 1 month after treatment there were highly significant differences between the LI-ESWT and placebo groups ( p < 0.0001 ) .
-RESULTS	Out of 60 men in the LI-ESWT group who completed the study , 47 ( 78 % ) men at FU1 and 43 ( 71 % ) at FU5 who were initially unable to achieve spontaneous erections hard enough for penetration ( EHS 2 ) were able to do so ( EHS 3 ) compared to none in the placebo group .
-RESULTS	The treatment was well tolerated and none of the men experienced treatment related discomfort or reported any adverse effects from the treatment .
-CONCLUSIONS	In this double-blind , placebo-controlled study , LI-ESWT demonstrated a positive long term clinical effect with improvement in erectile function of Indian men with vasculogenic ED who were prior responders to PDE5i therapy .
-CONCLUSIONS	The efficacy and tolerability of this treatment , coupled with its long term benefits and rehabilitative characteristics , make it an attractive new therapeutic option for men with vasculogenic erectile dysfunction .
-
-###24555585
-OBJECTIVE	The purpose of this article is to prospectively and directly compare the capabilities of non-contrast-enhanced MR angiography ( MRA ) , 4D contrast-enhanced MRA , and contrast-enhanced MDCT for assessing pulmonary vasculature in patients with non-small cell lung cancer ( NSCLC ) before surgical treatment .
-METHODS	A total of 77 consecutive patients ( 41 men and 36 women ; mean age , 71 years ) with pathologically proven and clinically assessed stage I NSCLC underwent thin-section contrast-enhanced MDCT , non-contrast-enhanced and contrast-enhanced MRA , and surgical treatment .
-METHODS	The capability for anomaly assessment of the three methods was independently evaluated by two reviewers using a 5-point visual scoring system , and final assessment for each patient was made by consensus of the two readers .
-METHODS	Interobserver agreement for pulmonary arterial and venous assessment was evaluated with the kappa statistic .
-METHODS	Then , sensitivity , specificity , and accuracy for the detection of anomalies were directly compared among the three methods by use of the McNemar test .
-RESULTS	Interobserver agreement for pulmonary artery and vein assessment was substantial or almost perfect ( = 0.72-0 .86 ) .
-RESULTS	For pulmonary arterial and venous variation assessment , there were no significant differences in sensitivity , specificity , and accuracy among non-contrast-enhanced MRA ( pulmonary arteries : sensitivity , 77.1 % ; specificity , 97.4 % ; accuracy , 87.7 % ; pulmonary veins : sensitivity , 50 % ; specificity , 98.5 % ; accuracy , 93.2 % ) , 4D contrast-enhanced MRA ( pulmonary arteries : sensitivity , 77.1 % ; specificity , 97.4 % ; accuracy , 87.7 % ; pulmonary veins : sensitivity , 62.5 % ; specificity , 100.0 % ; accuracy , 95.9 % ) , and thin-section contrast-enhanced MDCT ( pulmonary arteries : sensitivity , 91.4 % ; specificity , 89.5 % ; accuracy , 90.4 % ; pulmonary veins : sensitivity , 50 % ; specificity , 100.0 % ; accuracy , 95.9 % ) ( p > 0.05 ) .
-CONCLUSIONS	Pulmonary vascular assessment of patients with NSCLC before surgical resection by non-contrast-enhanced MRA can be considered equivalent to that by 4D contrast-enhanced MRA and contrast-enhanced MDCT .
-
-###24618336
-BACKGROUND	Effective targeted treatment is unavailable for most sarcomas and doxorubicin and ifosfamide-which have been used to treat soft-tissue sarcoma for more than 30 years-still have an important role .
-BACKGROUND	Whether doxorubicin alone or the combination of doxorubicin and ifosfamide should be used routinely is still controversial .
-BACKGROUND	We assessed whether dose intensification of doxorubicin with ifosfamide improves survival of patients with advanced soft-tissue sarcoma compared with doxorubicin alone .
-METHODS	We did this phase 3 randomised controlled trial ( EORTC 62012 ) at 38 hospitals in ten countries .
-METHODS	We included patients with locally advanced , unresectable , or metastatic high-grade soft-tissue sarcoma , age 18-60 years with a WHO performance status of 0 or 1 .
-METHODS	They were randomly assigned ( 1:1 ) by the minimisation method to either doxorubicin ( 75 mg/m ( 2 ) by intravenous bolus on day 1 or 72 h continuous intravenous infusion ) or intensified doxorubicin ( 75 mg/m ( 2 ) ; 25 mg/m ( 2 ) per day , days 1-3 ) plus ifosfamide ( 10 g/m ( 2 ) over 4 days with mesna and pegfilgrastim ) as first-line treatment .
-METHODS	Randomisation was stratified by centre , performance status ( 0 vs 1 ) , age ( < 50 vs 50 years ) , presence of liver metastases , and histopathological grade ( 2 vs 3 ) .
-METHODS	Patients were treated every 3 weeks till progression or unacceptable toxic effects for up to six cycles .
-METHODS	The primary endpoint was overall survival in the intention-to-treat population .
-METHODS	The trial is registered with ClinicalTrials.gov , number NCT00061984 .
-RESULTS	Between April 30 , 2003 , and May 25 , 2010 , 228 patients were randomly assigned to receive doxorubicin and 227 to receive doxorubicin and ifosfamide .
-RESULTS	Median follow-up was 56 months ( IQR 31-77 ) in the doxorubicin only group and 59 months ( 36-72 ) in the combination group .
-RESULTS	There was no significant difference in overall survival between groups ( median overall survival 128 months [ 955 % CI 105-143 ] in the doxorubicin group vs 143 months [ 125-165 ] in the doxorubicin and ifosfamide group ; hazard ratio [ HR ] 083 [ 955 % CI 067-103 ] ; stratified log-rank test p = 0076 ) .
-RESULTS	Median progression-free survival was significantly higher for the doxorubicin and ifosfamide group ( 74 months [ 95 % CI 66-83 ] ) than for the doxorubicin group ( 46 months [ 29-56 ] ; HR 074 [ 95 % CI 060-090 ] , stratified log-rank test p = 0003 ) .
-RESULTS	More patients in the doxorubicin and ifosfamide group than in the doxorubicin group had an overall response ( 60 [ 26 % ] of 227 patients vs 31 [ 14 % ] of 228 ; p < 00006 ) .
-RESULTS	The most common grade 3 and 4 toxic effects-which were all more common with doxorubicin and ifosfamide than with doxorubicin alone-were leucopenia ( 97 [ 43 % ] of 224 patients vs 40 [ 18 % ] of 223 patients ) , neutropenia ( 93 [ 42 % ] vs 83 [ 37 % ] ) , febrile neutropenia ( 103 ( 46 % ) vs 30 [ 13 % ] ) , anaemia ( 78 [ 35 % ] vs 10 [ 5 % ] ) , and thrombocytopenia ( 75 [ 33 % ] ) vs one [ < 1 % ] ) .
-CONCLUSIONS	Our results do not support the use of intensified doxorubicin and ifosfamide for palliation of advanced soft-tissue sarcoma unless the specific goal is tumour shrinkage .
-CONCLUSIONS	These findings should help individualise the care of patients with this disease .
-BACKGROUND	Cancer Research UK , EORTC Charitable Trust , UK NHS , Canadian Cancer Society Research Institute , Amgen .
-
-###26073354
-OBJECTIVE	To evaluate the relative bioavailability of single pill combination ( SPC ) tablets of linagliptin and metformin compared with separate tablets co-administered in healthy Chinese subjects .
-METHODS	This was an open-label , single-dose , randomized , two-period , crossover study in healthy Chinese subjects with two dose groups : linagliptin 2.5 mg/metformin 850 mg and linagliptin 2.5 mg/metformin 500 mg .
-METHODS	Within each group ( n = 24 ) , subjects received one dose of the SPC tablet in one period and one dose of the separate tablets in the other .
-METHODS	Primary endpoints were area under the plasma concentration-time curve from 0 to 72 hours ( AUC0-72 ) and maximum plasma concentration ( Cmax ) for linagliptin , and AUC from 0 to the last quantifiable concentration ( AUC0-tz ) and Cmax for metformin .
-RESULTS	With the linagliptin 2.5 mg/metformin 850 mg dose , the adjusted geometric mean ratio of the SPC to the separate tablets for linagliptin was 99.53 % ( 90 % confidence interval ( CI ) : 94.75-104 .55 ) for AUC0-72 and 101.93 % ( 90 % CI : 95.36-108 .95 ) for Cmax ; for metformin the ratio was 96.99 % ( 90 % CI : 90.62-103 .81 ) for AUC0-tz and 94.64 % ( 90 % CI : 85.43-104 .84 ) for Cmax .
-RESULTS	With the linagliptin 2.5 mg/metformin 500 mg dose , the ratio with linagliptin for AUC0-72 and Cmax was 100.81 % ( 90 % CI : 95.14-106 .82 ) and 111.37 % ( 90 % CI : 100.40-123 .54 ) , respectively ; the same statistical parameters with metformin for AUC0-tz and Cmax were 102.95 % ( 90 % CI : 96.24-110 .12 ) and 102.46 % ( 90 % CI : 92.20-113 .87 ) , respectively .
-CONCLUSIONS	SPC tablets of linagliptin and metformin were bioequivalent to separate tablets co-administered in healthy Chinese subjects .
-
-###25456099
-OBJECTIVE	To examine the effect of intensive glycemic control on cardiovascular disease events ( CVD ) among the major race/ethnic groups in a post-hoc analysis of the VADT .
-METHODS	Participants included 1111 non-Hispanic Whites , 307 Hispanics and 306 non-Hispanic Blacks randomized to intensive or standard glucose treatment in VADT .
-METHODS	Multivariable Cox proportional hazards models were constructed to assess the effect of intensive glucose treatment on CVD events among race/ethnic groups .
-RESULTS	Mean age was 60.4 years and median follow-up was 5.6 years .
-RESULTS	By design , modifiable risk factors were managed equally well in both treatment arms and only differed modestly between race/ethnic groups .
-RESULTS	HbA ( 1c ) decreased significantly from baseline with intensive glucose treatment in each race/ethnic group , with a trend for a greater response in Hispanics ( P = 0.02 for overall comparison between groups ) .
-RESULTS	Intensive glucose treatment was associated with reduced risk of CVD events for Hispanics but not for others ( hazard ratios ranged from 0.54 to 0.75 for Hispanics whereas they were consistently close to 1 for others ) .
-RESULTS	Sensitivity analyses with different definitions of race/ethnicity or limited to individuals free of previous known CVD yielded similar results .
-CONCLUSIONS	The results of these analyses support the hypothesis that race/ethnicity is worthy of consideration when tailoring intensive treatment for individuals with long-standing type 2 diabetes .
-CONCLUSIONS	However , additional studies are needed to confirm the findings of this post-hoc analysis .
-
-###24341511
-BACKGROUND	Audit and feedback to physicians is a commonly used quality improvement strategy , but its optimal design is unknown .
-BACKGROUND	This trial tested the effects of a theory-informed worksheet to facilitate goal setting and action planning , appended to feedback reports on chronic disease management , compared to feedback reports provided without these worksheets .
-METHODS	A two-arm pragmatic cluster randomized trial was conducted , with allocation at the level of primary care clinics .
-METHODS	Participants were family physicians who contributed data from their electronic medical records .
-METHODS	The ` usual feedback ' arm received feedback every six months for two years regarding the proportion of their patients meeting quality targets for diabetes and/or ischemic heart disease .
-METHODS	The intervention arm received these same reports plus a worksheet designed to facilitate goal setting and action plan development in response to the feedback reports .
-METHODS	Blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL ) values were compared after two years as the primary outcomes .
-METHODS	Process outcomes measured the proportion of guideline-recommended actions ( e.g. , testing and prescribing ) conducted within the appropriate timeframe .
-METHODS	Intention-to-treat analysis was performed .
-RESULTS	Outcomes were similar across groups at baseline .
-RESULTS	Final analysis included 20 physicians from seven clinics and 1,832 patients in the intervention arm ( 15 % loss to follow up ) and 29 physicians from seven clinics and 2,223 patients in the usual feedback arm ( 10 % loss to follow up ) .
-RESULTS	Ten of 20 physicians completed the worksheet at least once during the study .
-RESULTS	Mean BP was 128/72 in the feedback plus worksheet arm and 128/73 in the feedback alone arm , while LDL was 2.1 and 2.0 , respectively .
-RESULTS	Thus , no significant differences were observed across groups in the primary outcomes , but mean haemoglobin A1c was lower in the feedback plus worksheet arm ( 7.2 % versus 7.4 % , p < 0.001 ) .
-RESULTS	Improvements in both arms were noted over time for one-half of the process outcomes .
-CONCLUSIONS	Appending a theory-informed goal setting and action planning worksheet to an externally produced audit and feedback intervention did not lead to improvements in patient outcomes .
-CONCLUSIONS	The results may be explained in part by passive dissemination of the worksheet leading to inadequate engagement with the intervention .
-BACKGROUND	ClinicalTrials.gov NCT00996645 .
-
-###25247950
-OBJECTIVE	The objective of this study was to compare the image quality of a dual-energy nonlinear image blending technique at reduced load of contrast medium with a simulated 120-kVp linear blending technique at a full dose during portal venous phase MDCT of the abdomen .
-METHODS	Forty-five patients ( 25 men , 20 women ; mean age , 65.6 9.7 [ SD ] years ; mean body weight , 74.9 12.4 kg ) underwent contrast-enhanced single-phase dual-energy CT of the abdomen by a random assignment to one of three different contrast medium ( iomeprol 400 ) dose injection protocols : 1.3 , 1.0 , or 0.65 mL/kg of body weight .
-METHODS	The contrast-to-noise ratio ( CNR ) and noise at the portal vein , liver , aorta , and kidney were compared among the different datasets using the ANOVA .
-METHODS	Three readers qualitatively assessed all datasets in a blinded and independent fashion .
-RESULTS	Nonlinear blended images at a 25 % reduced dose allowed a significant improvement in CNR ( p < 0.05 for all comparisons ) , compared with simulated 120-kVp linear blended images at a full dose .
-RESULTS	No statistically significant difference existed in CNR and noise between the nonlinear blended images at a 50 % reduced dose and the simulated 120-kVp linear blended images at a full dose .
-RESULTS	Nonlinear blended images at a 50 % reduced dose were considered in all cases to have acceptable image quality .
-CONCLUSIONS	The dual-energy nonlinear image blending technique allows reducing the dose of contrast medium up to 50 % during portal venous phase imaging of the abdomen while preserving image quality .
-
-###26442399
-BACKGROUND	Major liver resection is associated with haemodynamic , hepatic and renal changes as a result of the procedure .
-OBJECTIVE	To compare Desflurane ( D ) versus Sevoflurane ( S ) on hepatic , renal functions , haemodynamics and perioperative course for cirrhotic patients undergoing major liver resection .
-METHODS	A prospective randomized control study with 50 patients ( Child A ) ( D , n = 25 and S , n = 25 ) .
-METHODS	End tidal D or S adjusted with Entropy ( 40-60 ) .
-METHODS	Haemodynamics monitored with invasive blood pressure and trans-oesophageal Doppler ( TED ) .
-METHODS	Liver and kidney function tests , blood Glutathione-S-transferase ( GST ) , urinary microalbuminuria ( Microalb ) were assayed .
-METHODS	Extubation time and anaesthetic consumption were recorded .
-RESULTS	Systemic vascular resistance ( SVR ) post-resection and stroke volume of D vs S were 835.04 12.02 vs 778.16 11.97 dyn.sec.cm ( -5 ) , P < 0.01 , and 85.72 2.95 vs 76.16 6.52 ml , P < 0.01 respectively .
-RESULTS	Doppler corrected flow time ( FTc ) between groups were comparable ( P > 0.05 ) .
-RESULTS	No difference post-operatively regarding hepatic and renal functions , and urine Microalb ( 14.76 3.95 vs l4 .24 8.65 g/ml , P = 0.78 ) , but a statistically difference was found with GST ( 0.046 [ symbols : see text ] , vs 0.043 [ symbols : see text ] IU/ml , P < 0.01 ) .
-RESULTS	Despite a higher D consumption ( 73 17 vs 64 22 ml , P = 0.102 ) , cost in Egyptian pounds ( LE ) was lower with D ( 141.14 32.90 vs 320.60 114.01 , LE , P < 0.01 ) .
-RESULTS	Extubation time and ICU stay with D vS ( 4.52 2 vs 7.72 2 min , P < 0.01 ) and ( 1.40 0.50 vs 1.64 0.48 , days P = 0.09 ) respectively .
-CONCLUSIONS	Neither D nor S were clinically superior to the other with respect to liver and kidneys functions , but D was found to preserve better the haemodynamic parameters and enhance recovery at a lower cost .
-
-###24634333
-OBJECTIVE	Acute kidney injury ( AKI ) after cardiopulmonary bypass surgery to correct congenital heart disease is common .
-OBJECTIVE	We prevent fluid overload and further cardiac compromise in oliguric infants with continuous peritoneal dialysis ( CPD ) .
-OBJECTIVE	The effect of CPD on kidney recovery is unknown , thus indications to discontinue CPD are unclear .
-OBJECTIVE	We aimed to determine if CPD affects kidney recovery , measured by urine output and novel urinary AKI biomarker concentrations .
-METHODS	Twenty infants < 90 days old with congenital heart disease who underwent bypass surgery and were post-operatively treated with CPD were randomized at the time of clinical readiness for CPD discontinuation to 1 ) discontinue CPD ( control ) or 2 ) continue 24 h more CPD ( experimental ) .
-METHODS	Urine output ( ml/kg per h ) , total output ( ml/kg per h ) and urinary neutrophil gelatinase-associated lipocalin , interleukin-18 , liver-type fatty acid binding protein , and kidney injury molecule-1 were assessed post-surgery until CPD catheter removal .
-RESULTS	24 hours preceding randomization , there were no differences in mean urine output or total output ; 24 hours post-randomization , the control group had higher mean urine output ( 4.2 2.6 ml/kg per h vs. 2.8 2.0 ml/kg per h , p = 0.02 ) but lower total output ( 6.3 2.1 ml/kg per h vs. 4.7 2.7 ml/kg per h , p = 0.01 ) .
-RESULTS	Median biomarker concentrations did not differ significantly between groups at any time point .
-CONCLUSIONS	Our results suggest renal replacement therapy does not change the time course of kidney function recovery .
-
-###25467005
-OBJECTIVE	To evaluate the long-term effects of dietary intervention on gastrointestinal symptoms after highly dose-escalated radiotherapy for localized prostate cancer , using boost with protons or high-dose-rate brachytherapy .
-METHODS	Patients were randomized to an intervention group ( n = 64 ) advised to reduce insoluble dietary fiber and lactose intake , or to a standard care group ( n = 66 ) advised to continue their usual diet .
-METHODS	Gastrointestinal symptoms , other domains of health-related quality of life ( HRQOL ) , and dietary intake were evaluated for 24months post-radiotherapy with the European Organization for Research and Treatment of Cancer quality-of-life questionnaires QLQ-C30 and QLQ-PR25 , Gastrointestinal Side Effects Questionnaire , and Food Frequency Questionnaire .
-METHODS	The effect of the intervention on gastrointestinal symptoms was evaluated using generalized estimating equations .
-RESULTS	Dietary intervention had no obvious effect on long-term gastrointestinal symptoms or HRQOL .
-RESULTS	The intervention group markedly reduced their dietary fiber and lactose intake during radiotherapy , but adherence tended to decline over time .
-RESULTS	The vast majority of long-term gastrointestinal symptoms were reported as ' a little ' , with a noticeable difference from pre-treatment only for unintentional stool leakage , limitations on daily activities , and mucus discharge .
-CONCLUSIONS	Long-term gastrointestinal symptoms were predominantly mild , and dietary intervention was not superior to a usual diet in preventing these symptoms .
-
-###25344328
-BACKGROUND	Longstanding complex regional pain syndrome ( CRPS ) is refractory to treatment with established analgesic drugs in most cases , and for many patients , alternative pain treatment approaches , such as with neuromodulation devices or rehabilitation methods , also do not work .
-BACKGROUND	The development of novel , effective treatment technologies is , therefore , important .
-BACKGROUND	There are preliminary data suggesting that low-dose immunoglobulin treatment may significantly reduce pain from longstanding CRPS .
-METHODS	LIPS is a multicentre ( United Kingdom ) , double-blind , randomised parallel group , placebo-controlled trial , designed to evaluate the efficacy , safety , and tolerability of intravenous immunoglobulin ( IVIg ) 0.5 g/kg plus standard treatment , versus matched placebo plus standard treatment in 108 patients with longstanding complex regional pain syndrome .
-METHODS	Participants with moderate or severe CRPS of between 1 and 5 years duration will be randomly allocated to receive IVIg 0.5 g/kg ( IntratectTM 50 g/l solution for infusion ) or matching placebo administered day 1 and day 22 after randomisation , followed by two optional doses of open-label medication on day 43 after randomisation and on day 64 after randomisation .
-METHODS	The primary outcome is the patients ' pain intensity in the IVIG group compared with the placebo group , between 6 and 42 days after randomisation .
-METHODS	The primary trial objective is to confirm the efficacy and confidently determine the effect size of the IVIG treatment technology in this group of patients .
-BACKGROUND	ISRCTN42179756 ( Registered 28 June 13 ) .
-
-###25407227
-BACKGROUND	In vitro fertilisation ( IVF ) treatment provides an opportunity to study early developmental responses to periconceptional dietary interventions .
-BACKGROUND	Retrospective studies have suggested links between preconception diet and fertility , and more recently , a `` Mediterranean '' diet has been reported to increase pregnancy rates by up to 40 % .
-BACKGROUND	In addition , a prospective study examining increased intake of omega-3 polyunsaturated fats demonstrated a quickened rate of embryo development after IVF .
-BACKGROUND	However , up to now , few prospective randomised controlled trials have investigated the impact of periconceptional dietary interventions on fertility outcomes .
-METHODS	The study is a randomised controlled trial of a dietary intervention consisting of olive oil for cooking , an olive oil based spread , and a daily supplement drink enriched with Vitamin D ( 10 microgram daily ) and marine omega-3 fatty acids ( 2g daily ) for 6weeks preconception versus a control diet of sunflower seed oil for cooking , a sunflower oil based spread , and a daily supplement drink without added Vitamin D or marine omega-3 fatty acids .
-METHODS	Couples undergoing IVF will be randomised to either the intervention or control group ( 55 in each arm ) .
-METHODS	The primary endpoint is embryo developmental competency in vitro , measured by validated morphokinetic markers .
-METHODS	Secondary outcomes will include the effect of the dietary intervention on the nutritional content of the intrauterine environment .
-CONCLUSIONS	This approach will enable rigorous examination of the impact of the dietary intervention on early embryo development , together with the influence of the peri-implantation intra-uterine nutritional environment .
-BACKGROUND	ISRCTN50956936 .
-
-###24372521
-BACKGROUND	Traditional Chinese acupuncture ( TCA ) is an effective alternative treatment in migraine headache .
-BACKGROUND	The aim of this study was to compare the therapeutic effect of Yamamoto new scalp acupuncture ( YNSA ) , a recently developed microcupuncture system , with TCA for the prophylaxis and treatment of migraine headache .
-METHODS	In a randomized clinical trial , 80 patients with migraine headache were assigned to receive YNSA or TCA .
-METHODS	A pain visual analogue scale ( VAS ) and migraine therapy assessment questionnaire ( MTAQ ) were completed before treatment , after 6 and 18 sections of treatment , and 1 month after completion of therapy .
-RESULTS	All the recruited patients completed the study .
-RESULTS	Baseline characteristics were similar between the two groups .
-RESULTS	Frequency and severity of migraine attacks , nausea , the need for rescue treatment , and work absence rate decreased similarly in both groups .
-RESULTS	Recovery from headache and ability to continue daily activities 2 hours after medical treatment showed similar improvement in both groups ( p > 0.05 ) .
-CONCLUSIONS	Classic acupuncture and YNSA are similarly effective in the prophylaxis and treatment of migraine headache and may be considered as alternatives to pharmacotherapy .
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-###24886647
-BACKGROUND	The latest meta-analysis demonstrated that acupuncture improves pregnancy rates among women undergoing in vitro fertilization-embryo transfer ( IVF-ET ) , and surface acupoint stimulation , such as transcutaneous electrical acupoint stimulation ( TEAS ) , may have the same or better potential .
-METHODS	To explore the effect of TEAS on the clinical pregnancy rate ( CPR ) and live birth rate ( LBR ) compared with real acupuncture and controls in women undergoing IVF , a multicenter , randomized controlled trial will be conducted .
-METHODS	The inclusion criteria are the following : infertile women < 40years of age undergoing a fresh IVF or intracytoplasmic sperm injection cycle , and the study will be restricted to women with the potential for a lower success rate as defined by two or more previous unsuccessful ETs ( fresh or frozen ) .
-METHODS	Those who have severe illnesses possibly precluding IVF or pregnancy , have FSH levels greater than 20IU/L , received donor eggs , had been previously randomized for this study or had undergone acupuncture ( in any modality ) as infertility treatment will be excluded .
-METHODS	The subjects will be randomly assigned to the TEAS group ( IVF+TEAS ) , the electro-acupuncture ( EA ) group ( IVF+EA ) , or the control group ( only IVF ) .
-METHODS	A total sample size of 2,220 women is required to detect differences in CPR among the three groups .
-METHODS	TEAS or EA treatments will start once every two or three days from day 3 of menstruation in the ovarian stimulation cycle until the day of ET .
-METHODS	The parameters of TEAS or EA will be the following : a frequency of 2/100Hz , a moderate electrical current of 3 to 5mA for TEAS and 0.8 to 1.0 mA for EA .
-METHODS	The primary outcome is CPR .
-METHODS	Secondary outcomes are LBR , the number of oocytes aspirated and the total gonadotropin dose used in the stimulation cycle .
-CONCLUSIONS	This study will provide significant evidence for using a new method ( TEAS ) in IVF .
-BACKGROUND	ClinicalTrials.govID : NCT01608048 ( 05/24/2012 ) .
-
-###24769601
-OBJECTIVE	To assess the efficacy of Korean Immigrants and Mammography-Culture-Specific Health Intervention ( KIM-CHI ) , an educational program for Korean American ( KA ) couples designed to improve mammography uptake among KA women .
-METHODS	A two-group cluster randomized , longitudinal , controlled design .
-METHODS	50 KA religious organizations in the Chicago area .
-METHODS	428 married KA women 40 years of age or older who had not had a mammogram in the past year .
-METHODS	The women and their husbands were recruited from 50 KA religious organizations .
-METHODS	Couples were randomly assigned to intervention or attention control groups .
-METHODS	Those in the KIM-CHI program ( n = 211 couples ) were compared to an attention control group ( n = 217 couples ) at baseline , as well as at 6 and 15 months postintervention on mammogram uptake .
-METHODS	Sociodemographic variables and mammography uptake were measured .
-METHODS	Level of acculturation was measured using the Suinn-Lew Asian Self-Identity Acculturation Scale .
-METHODS	Researchers asked questions about healthcare resources and use , health insurance status , usual source of care , physical examinations in the past two years , family history of breast cancer , and history of mammography .
-RESULTS	The KIM-CHI group showed statistically significant increases in mammography uptake compared to the attention control group at 6 months and 15 months postintervention .
-CONCLUSIONS	The culturally targeted KIM-CHI program was effective in increasing mammogram uptake among nonadherent KA women .
-CONCLUSIONS	Nurses and healthcare providers should consider specific health beliefs as well as inclusion of husbands or significant others .
-CONCLUSIONS	They also should target education to be culturally relevant for KA women to effectively improve frequency of breast cancer screening .
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-###24836655
-OBJECTIVE	The authors analyzed headache relief after anterior cervical discectomy .
-OBJECTIVE	Headache may be relieved after anterior cervical discectomy , but the mechanism is unknown .
-OBJECTIVE	If headaches were directly referred from upper cervical pathology , more headache relief would be expected from surgery performed at higher cervical levels .
-OBJECTIVE	If spinal kinesthetics were the mechanism , then headache relief may differ between arthroplasty and fusion .
-OBJECTIVE	Headache relief after anterior cervical discectomy was quantified by the operated disc level and by the method of operation ( arthroplasty vs arthrodesis ) .
-METHODS	The authors performed a post hoc analysis of an artificial disc trial .
-METHODS	Data on headache pain were extracted from the Neck Disability Index ( NDI ) questionnaire .
-RESULTS	A total of 260 patients underwent single-level arthroplasty or arthodesis .
-RESULTS	Preoperatively , 52 % reported NDI headache scores of 3 or greater , compared with only 13 % -17 % postoperatively .
-RESULTS	The model-based mean NDI headache score at baseline was 2.5 ( 95 % CI 2.3-2 .7 ) and was reduced by 1.3 points after surgery ( 95 % CI 1.2-1 .4 , p < 0.001 ) .
-RESULTS	Higher cervical levels were associated with a greater degree of preoperative headache , but there was no association with headache relief .
-RESULTS	There was no significant difference in headache relief between arthroplasty and arthrodesis .
-CONCLUSIONS	Most patients with symptomatic cervical spondylosis have headache as a preoperative symptom ( 88 % ) .
-CONCLUSIONS	Anterior cervical discectomy with both arthroplasty and arthrodesis is associated with a durable decrease in headache .
-CONCLUSIONS	Headache relief is not related to the level of operation .
-CONCLUSIONS	The mechanism for headache reduction remains unclear .
-
-###24380874
-BACKGROUND	Mild dysphonia in childhood is surprisingly common , yet moderate to severe dysphonia is rare .
-BACKGROUND	The latter has been associated with complex medical conditions and congenital abnormalities .
-BACKGROUND	Intubation injury has also been documented as a cause of childhood dysphonia .
-BACKGROUND	Children born very preterm may be intubated as part of the intensive care administered in the perinatal and neonatal periods , yet there are few studies investigating dysphonia in this population .
-BACKGROUND	This study will be the first to : use an objective acoustic voice assessment in a paediatric study , document the incidence of dysphonia in very preterm children at school age , and conduct a controlled trial of behavioural voice therapy in this population .
-METHODS	This study will consist of three phases : assessment of voice quality and its impact on quality of life in up to 200 children born at less than 32 weeks ' gestation : assessment of the nature and extent of laryngeal pathology in children with moderate to severe dysphonia ; and a non-blinded , randomised controlled trial of behavioural voice therapy in children with moderate to severe dysphonia .
-CONCLUSIONS	This study will be the first to use clinical assessment to examine the voice quality of very preterm children , and to use fibre optic endoscopic evaluation of laryngeal function to determine the nature and extent of any laryngeal pathology in such children .
-CONCLUSIONS	Those participants with significant voice difficulties will be randomised to receive treatment immediately or after the eight week assessment .
-BACKGROUND	This study is registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12613001015730/ACTRN12613001012763 ) .
-
-###25444717
-BACKGROUND	Male and female condom ( FC ) functional performance failure declines with user experience .
-BACKGROUND	With the recent availability of a wider range of FCs , it is important to know if women with experience in using one type of FC are more proficient in using another type , even if the FC design is quite different .
-METHODS	A randomized , noninferiority crossover clinical trial assessed the function of four FCs ( FC2 , Woman 's Condom , Cupid and VA w.o.w ) among 300 women in Durban , South Africa .
-METHODS	FC functional failure ( breakage , slippage , invagination and misdirection ) by condom type and use period was investigated in women using five FCs of each type ( 20 FC uses in total ) .
-RESULTS	Of the 5364 condoms used during intercourse by 272 women , 200 clinical failures occurred in 195 condoms ( 190 condoms had one failure , and 5 had two failures ) .
-RESULTS	Total clinical failure was comparable across FC types .
-RESULTS	Of the 195 condoms in which failures occurred , the number of failures in the first condom use period was 103 ( 7.7 % ) , decreasing to 43 events ( 3.2 % ) in the second , 33 ( 2.5 % ) in the third and 16 ( 1.2 % ) in the fourth .
-RESULTS	Only 2 failures were reported in the 20th use of an FC compared to 29 in the first use , irrespective of condom type .
-CONCLUSIONS	FC failure rates decreased markedly after use of the first five condoms regardless of FC type and continued to fall across the next three use periods .
-CONCLUSIONS	FC failure rates decrease over 20 uses , regardless of FC condom type used .
-CONCLUSIONS	The decrease is higher at the beginning of use , indicating that improvement is greatest after the first five uses .
-
-###24814090
-BACKGROUND	Etrolizumab is a humanised monoclonal antibody that selectively binds the 7 subunit of the heterodimeric integrins 47 and E7 .
-BACKGROUND	We aimed to assess etrolizumab in patients with moderately-to-severely active ulcerative colitis .
-METHODS	In this double-blind , placebo-controlled , randomised , phase 2 study , patients with moderately-to-severely active ulcerative colitis who had not responded to conventional therapy were recruited from 40 referral centres in 11 countries .
-METHODS	Eligible patients ( aged 18-75 years ; Mayo Clinic Score [ MCS ] of 5 of higher [ or 6 in USA ] ; and disease extending 25 cm or more from anal verge ) were randomised ( 1:1:1 ) to one of two dose levels of subcutaneous etrolizumab ( 100 mg at weeks 0 , 4 , and 8 , with placebo at week 2 ; or 420 mg loading dose [ LD ] at week 0 followed by 300 mg at weeks 2 , 4 , and 8 ) , or matching placebo .
-METHODS	The primary endpoint was clinical remission at week 10 , defined as MCS of 2 or less ( with no individual subscore of > 1 ) , analysed in the modified intention-to-treat population ( mITT ; all randomly assigned patients who had received at least one dose of study drug , had at least one post-baseline disease-activity assessment , and had a centrally read screening endoscopic subscore of 2 ) .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01336465 .
-RESULTS	Between Sept 2 , 2011 , and July 11 , 2012 , 124 patients were randomly assigned , of whom five had a endoscopic subscore of 0 or 1 and were excluded from the mITT population , leaving 39 patients in the etrolizumab 100 mg group , 39 in the etrolizumab 300 mg plus LD group , and 41 in the placebo group for the primary analyses .
-RESULTS	No patients in the placebo group had clinical remission at week 10 , compared with eight ( 21 % [ 95 % CI 7-36 ] ) patients in the etrolizumab 100 mg group ( p = 00040 ) and four ( 10 % [ 02-24 ] ) patients in the 300 mg plus LD group ( p = 0048 ) .
-RESULTS	Adverse events occurred in 25 ( 61 % ) of 41 patients in the etrolizumab 100 mg group ( five [ 12 % ] of which were regarded as serious ) , 19 ( 48 % ) of 40 patients in the etrolizumab 300 mg plus LD group ( two [ 5 % ] serious ) , and 31 ( 72 % ) of 43 patients in the placebo group ( five [ 12 % ] serious ) .
-CONCLUSIONS	Etrolizumab was more likely to lead to clinical remission at week 10 than was placebo .
-CONCLUSIONS	Therefore , blockade of both 47 and E7 might provide a unique therapeutic approach for the treatment of ulcerative colitis , and phase 3 studies have been planned .
-BACKGROUND	Genentech .
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-###24613188
-BACKGROUND	Sildenafil ( Viagra , Pfizer ) is being used to treat pulmonary hypertension ( PH ) .
-BACKGROUND	However , there are limited data on the effects of sildenafil on patients with PH after left-sided valvular surgery .
-BACKGROUND	The purpose of this study was to determine the optimal dosage and the effects of sildenafil on prognosis of patients with PH after left-sided valvular surgery .
-METHODS	This randomised controlled trial , double-blind study enrolled patients with PH undergoing left-sided valvular surgery in our hospital from January to December , 2010 .
-METHODS	Ninety patients were enrolled .
-METHODS	And 0.5 mg/kg sildenafil citrate or placebo was administered through nasogastric tubes , the haemodynamics changes in the 0.5 / 1/2/4 hours were assessed .
-METHODS	The sildenafil citrate/placebo was continued to the discharges and the early prognoses of these patients were compared .
-RESULTS	Compared with placebo , a 0.5 mg/kg dose of sildenafil significantly reduced the time of mechanical ventilation , stay-in-ICU and hospitalisation duration .
-CONCLUSIONS	Sildenafil might be beneficial to the early prognosis of patients with PH after left-sided valvular surgery .
-
-###25261967
-BACKGROUND	Studies suggest that obesity is associated with lower risk of prostate cancer but more aggressive cancers .
-BACKGROUND	As obesity lowers PSA levels , these observations may be influenced by detection bias .
-BACKGROUND	We examined the association between obesity and risk of low - and high-grade prostate cancer in REDUCE , in which biopsies were largely independent of PSA .
-METHODS	The REDUCE study tested dutasteride for prostate cancer risk reduction in men with a PSA of 2.5 to 10.0 ng/mL and a negative biopsy .
-METHODS	Study participants included 6,729 men who underwent at least one on-study biopsy .
-METHODS	The association between baseline body mass index ( BMI < 25 kg/m ( 2 ) normal weight ; 25-29 .9 kg/m ( 2 ) overweight ; and 30 kg/m ( 2 ) obese ) and risk of high-grade ( Gleason 7 ) or low-grade prostate cancer ( Gleason < 7 ) versus no prostate cancer was examined using multinomial logistic regression .
-RESULTS	Overall , 1,739 men ( 27 % ) were normal weight , 3,384 ( 53 % ) overweight , and 1,304 ( 20 % ) were obese .
-RESULTS	Obesity was associated with lower risk of low-grade prostate cancer in both univariable ( OR , 0.74 ; P = 0.001 ) and multivariable analyses ( OR , 0.79 ; P = 0.01 ) .
-RESULTS	In univariable analysis , obesity was not associated with high-grade prostate cancer ( OR , 1.08 ; P = 0.50 ) .
-RESULTS	However , in multivariable analysis , obesity was associated with increased risk of high-grade prostate cancer ( OR , 1.28 ; P = 0.042 ) .
-RESULTS	This analysis was not able to address how obesity may influence prostate cancer progression .
-CONCLUSIONS	Obesity is associated with decreased risk of low-grade and increased risk of high-grade prostate cancer .
-CONCLUSIONS	These data provide further support to the hypothesis that obesity is associated with aggressive prostate cancer .
-CONCLUSIONS	Obesity is linked with aggressive prostate cancer .
-CONCLUSIONS	Avoiding obesity may prevent the risk of developing high-grade prostate cancer .
-
-###25602634
-OBJECTIVE	To evaluate the effect of a topical , nonsteroidal antiinflammatory drug , nepafenac 0.1 % , in eyes with noncentral diabetic macular edema .
-METHODS	Multicenter , double-masked randomized trial .
-METHODS	Individuals with good visual acuity and noncentral-involved diabetic macular edema were randomly assigned to nepafenac 0.1 % ( N = 61 ) or placebo ( nepafenac vehicle , N = 64 ) 3 times a day for 12 months .
-METHODS	The primary outcome was mean change in optical coherence tomography retinal volume at 12 months .
-RESULTS	Mean baseline retinal volume was 7.8 mm .
-RESULTS	At 12 months , in the nepafenac and placebo groups respectively , mean change in retinal volume was -0.03 mm and -0.02 mm ( treatment group difference : -0.02 , 95 % confidence interval : -0.27 to 0.23 , P = 0.89 ) .
-RESULTS	Central-involved diabetic macular edema was present in 7 eyes ( 11 % ) and 9 eyes ( 14 % ) at the 12-month visit ( P = 0.79 ) , respectively .
-RESULTS	No differences in visual acuity outcomes were identified .
-RESULTS	One study participant developed a corneal melt after using nepafenac in the nonstudy eye , which had a history of severe dry eye .
-RESULTS	No additional safety concerns were evident .
-CONCLUSIONS	In eyes with noncentral diabetic macular edema and good visual acuity , topical nepafenac 0.1 % 3 times daily for 1 year likely does not have a meaningful effect on optical coherence tomography-measured retinal thickness .
-
-###24253484
-OBJECTIVE	Menopause predisposes women to sleep-disordered breathing ( SDB ) and sleep disturbances .
-OBJECTIVE	Progestin has a potential to stimulate breathing and to induce sleep .
-OBJECTIVE	Our goal was to test these effects objectively and to compare them with the effects of nasal continuous positive airway pressure ( CPAP ) , which is the standard treatment of SDB .
-METHODS	In a placebo-controlled , double-blind , parallel-group trial , we investigated 34 postmenopausal women ( 17 in the placebo group and 17 in the medroxyprogesterone acetate [ MPA ] group ) whose SDB had been treated with nasal CPAP for 6 months to 8 years prior to study entry .
-METHODS	The 6-week trial included measurements with CPAP at baseline , after 14 days of placebo or MPA ( 60 mg daily ) , and after a 3-week washout .
-METHODS	The participants discontinued their nasal CPAP therapy 1 week after baseline measurements and went on with study medication .
-RESULTS	Two weeks after discontinuation of CPAP therapy , nightly oxygen saturation was sustained higher ( P = 0.004 ) and arterial carbon dioxide tension was lower ( P < 0.001 ) with MPA than with placebo .
-RESULTS	Carbon dioxide was also lower than during CPAP ( P < 0.001 ) , and this effect was sustained beyond 3 weeks after the cessation of MPA ( P < 0.001 ) .
-RESULTS	However , the apnea-hypopnea index of CPAP increased and sleep deteriorated similarly on MPA and placebo after withdrawal of CPAP therapy .
-CONCLUSIONS	In postmenopausal women with SDB , MPA induces a long-lasting stimulatory effect on breathing without improving sleep quality or the apnea-hypopnea index .
-
-###24471747
-OBJECTIVE	To evaluate the thermal antinociceptive and sedative effects and duration of action of tramadol hydrochloride after oral administration to American kestrels ( Falco sparverius ) .
-METHODS	12 healthy 3-year-old American kestrels .
-METHODS	Tramadol ( 5 , 15 , and 30 mg/kg ) and a control suspension were administered orally in a masked randomized crossover experimental design .
-METHODS	Foot withdrawal response to a thermal stimulus was determined 1 hour before ( baseline ) and 0.5 , 1.5 , 3 , 6 , and 9 hours after treatment .
-METHODS	Agitation-sedation scores were determined 3 to 5 minutes before each thermal stimulus test .
-RESULTS	The lowest dose of tramadol evaluated ( 5 mg/kg ) significantly increased the thermal foot withdrawal thresholds for up to 1.5 hours after administration , compared with control treatment values , and for up to 9 hours after administration , compared with baseline values .
-RESULTS	Tramadol at doses of 15 and 30 mg/kg significantly increased thermal thresholds at 0.5 hours after administration , compared with control treatment values , and up to 3 hours after administration , compared with baseline values .
-RESULTS	No significant differences in agitation-sedation scores were detected between tramadol and control treatments .
-CONCLUSIONS	Results indicated oral administration of 5 mg of tramadol/kg significantly increased thermal nociception thresholds for kestrels for 1.5 hours , compared with a control treatment , and 9 hours , compared with baseline values ; higher doses resulted in less pronounced antinociceptive effects .
-CONCLUSIONS	Additional studies with other types of stimulation , formulations , dosages , routes of administration , and testing times would be needed to fully evaluate the analgesic and adverse effects of tramadol in kestrels and other avian species .
-
-###24763187
-BACKGROUND	Quantifying lifetime physical activity using self-reported measures is challenging due to reliance on recall , especially in older populations .
-BACKGROUND	The purpose of this study was to determine the 1-year reproducibility of the Veterans Physical Activity Questionnaire ( VAPAQ ) in a cohort of patients with documented abdominal aortic aneurysm disease ( AAA ) .
-METHODS	Subjects included men ( n = 52 ) and women ( n = 3 ) enrolled in AAA STOP , a randomized trial designed to test the ability of supervised exercise training to modify AAA biology and early disease progression .
-RESULTS	The overall correlation coefficient for lifetime recreational energy expenditure between the 2 examinations was 0.93 ( P < .001 ) , with an overall difference of 26 kcal/week , a typical error ( standard deviation of the differences ) of 171 kcals/week , and a coefficient of variation ( CV ) of 15.5 % .
-CONCLUSIONS	The VAPAQ is a reproducible tool to quantify lifetime energy expenditure in older adults with documented vascular disease .
-
-###24774351
-BACKGROUND	Depression and diabetes cause significant burden for patients and the healthcare system and , when co-occurring , result in poorer self-care behaviors and worse glycemic control than for either condition alone .
-BACKGROUND	However , the clinical management of these comorbid conditions is complicated by a host of patient , provider , and system-level barriers that are especially problematic for patients in rural locations .
-BACKGROUND	Patient-centered medical homes provide an opportunity to integrate mental and physical health care to address the multifaceted needs of complex comorbid conditions .
-BACKGROUND	Presently , there is a need to not only develop robust clinical interventions for complex medically ill patients but also to find feasible ways to embed these interventions into the frontlines of existing primary care practices .
-METHODS	This randomized controlled trial uses a hybrid effectiveness-implementation design to evaluate the Healthy Outcomes through Patient Empowerment ( HOPE ) intervention , which seeks to simultaneously address diabetes and depression for rural veterans in Southeast Texas .
-METHODS	A total of 242 Veterans with uncontrolled diabetes and comorbid symptoms of depression will be recruited and randomized to either the HOPE intervention or to a usual-care arm .
-METHODS	Participants will be evaluated on a host of diabetes and depression-related measures at baseline and 6 - and 12-month follow-up .
-METHODS	The trial has two primary goals : 1 ) to examine the effectiveness of the intervention on both physical ( diabetes ) and emotional health ( depression ) outcomes and 2 ) to simultaneously pilot test a multifaceted implementation strategy designed to increase fidelity and utilization of the intervention by coaches interfacing within the primary care setting .
-CONCLUSIONS	This ongoing blended effectiveness-implementation design holds the potential to advance the science and practice of caring for complex medically ill patients within the constraints of a busy patient-centered medical home .
-BACKGROUND	Behavioral Activation Therapy for Rural Veterans with Diabetes and Depression : NCT01572389 .
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-###25730446
-OBJECTIVE	To investigate the efficacy of medical honey as topical treatment of chronically discharging open mastoid cavities in comparison with conventional eardrops .
-METHODS	Single-center , prospective , randomized controlled , double-dose trial of 12 weeks .
-METHODS	Twenty-eight patients diagnosed as having a chronically discharging open mastoid cavity underwent medical honey gel ( intervention ) or conventional eardrops ( control ) treatment .
-METHODS	Treatment interventions were repeated after 4 weeks .
-METHODS	Visual analogue scale of ear complaints , cavity inflammation , and bacterial infection .
-RESULTS	Most patients had a cavity with localized granulation .
-RESULTS	After treatment , inflammation score decreased in both groups ( p < 0.05 ) , with more pronounced inflammation-free cavities in the honey group .
-RESULTS	Honey treatment resulted in less discomfort ( p < 0.001 ) and otorrhea ( p < 0.001 ) , even after correction for additional medication use ( p < 0.05 , p < 0.01 ) .
-RESULTS	This decrease was not seen in the control group .
-RESULTS	Pain and itching did not change on treatment .
-RESULTS	Most cavities were infected with Pseudomonas species and Staphylococcus aureus .
-RESULTS	After treatment , a 23 % increase of negative culture was seen with honey compared with 30 % in the control group ( nonsignificant ) .
-RESULTS	No serious adverse reactions were found .
-CONCLUSIONS	Medical honey gel is a safe alternative treatment option for patients with a chronically discharging open mastoid cavity and beneficial in reducing discomfort , otorrhea , and inflammation with a bactericidal effect .
-
-###24559812
-BACKGROUND	Obesity is a chronic condition related to serious morbidity and mortality of increasing incidence and prevalence .
-BACKGROUND	Several studies show a significantly higher weight loss with acupuncture treatment .
-BACKGROUND	This is the first prospective , randomized , double-blinded study , testing the effects of auricular electroacupuncture on weight loss in obese female patients .
-METHODS	56 female obese patients ( age > 18 , Body Mass Index , BMI > 25 ) were randomized to receive either auricular acupuncture with electrical stimulation with a P-Stim device ( verum group , n = 28 ) or placebo treatment with a P-Stim dummy ( n = 28 ) for four days .
-METHODS	Three auricular acupuncture points were chosen ( hunger 18 , stomach 87 and colon 91 ) .
-METHODS	The treatment was performed once a week for a period of six weeks .
-METHODS	A follow-up visit was performed after 4 weeks .
-METHODS	At each visit body weight , BMI ( Body Mass Index ) and body fat were measured .
-RESULTS	Relative reduction of body weight was significantly greater in the verum group ( -3.73 % ; CI = -4.70 to -2.76 ) than in the placebo group ( -0.70 % ; CI = -1.57 to +0.16 ; p < 0.001 ) In addition we also observed a significant reduction of BMI ( p < 0.001 ) in the verum group ( -3.62 % ; CI = -4.39 to -2.84 ) compared to placebo ( -0.82 % ; CI = -1.55 to -0.10 ; p < 0.001 ) .
-RESULTS	No patient reported side effects related to acupuncture .
-CONCLUSIONS	In conclusion electrical auricular acupuncture could be a safe , additive , non-pharmacological treatment in obese patients .
-
-###25557807
-OBJECTIVE	In behavioral studies of weight loss programs , participants typically receive interventions free of charge .
-OBJECTIVE	Understanding an individual 's willingness to pay ( WTP ) for weight loss programs could be helpful when evaluating potential funding models .
-OBJECTIVE	This study assessed WTP for the continuation of a weight loss program at the end of a weight loss study .
-METHODS	WTP was assessed with monthly coaching contacts at the end of the two-year Hopkins POWER trial .
-METHODS	Interview-administered questionnaires determined the amount participants were willing to pay for continued intervention .
-METHODS	Estimated maximum payment was calculated among those willing to pay and was based on quantile regression adjusted for age , body mass index , race , sex , household income , treatment condition , and weight change at 24 months .
-RESULTS	Among the participants ( N = 234 ) , 95 % were willing to pay for continued weight loss intervention ; the adjusted median payment was $ 45 per month .
-RESULTS	Blacks had a higher adjusted median WTP ( $ 65/month ) compared to Non-Blacks ( $ 45/month ) , P = 0.021 .
-CONCLUSIONS	A majority of participants were willing to pay for a continued weight loss intervention with a median monthly amount that was similar to the cost of commercial weight loss programs .
-
-###25303096
-OBJECTIVE	Optimal physical behaviour is important , as physical inactivity contributes to functional deterioration and reduced social participation .
-OBJECTIVE	Nevertheless , research showed that persons with cerebral palsy ( CP ) have low physical activity levels .
-OBJECTIVE	The objective of this study is to evaluate the effectiveness of a lifestyle intervention programme on physical behaviour .
-METHODS	Fifty-seven persons ( 36 completed the total study ) with spastic CP ( age range 16 to 25y ; 27 males , 30 females ) , classified as Gross Motor Function Classification System levels I-IV were included in this randomized controlled trial .
-METHODS	Twenty-nine participants had a unilateral CP and 27 had a bilateral CP .
-METHODS	A 6-month lifestyle intervention consisting of fitness training and counselling on physical behaviour and sports participation was evaluated .
-METHODS	Physical behaviour was objectively measured using ambulatory activity monitors .
-METHODS	Self-reported physical activity was determined using the Physical Activity Scale for Individuals with Physical Disabilities .
-RESULTS	The intervention did not affect the objectively measured physical activity during the intervention ( beta = 0.34 , CI = -1.70 to 2.37 ) or at follow-up ( beta = 0.30 , CI = -1.99 to 2.59 ) .
-RESULTS	Self-reported physical activity was positively affected during the intervention period ( beta = 7.61 , CI = 0.17-15 .05 ) ; however , this effect was not present at follow-up ( beta = 3.65 , CI = -3.05 to 10.36 ) .
-CONCLUSIONS	The lifestyle intervention was ineffective in eliciting a behavioural change towards more favourable physical behaviour in adolescents and young adults with spastic CP .
-
-###25009196
-BACKGROUND	Animal models and retrospective clinical data suggest that certain anaesthetic techniques can attenuate immunosuppression and minimize metastasis after cancer surgery .
-BACKGROUND	Natural killer ( NK ) T cells are a critical component of the anti-tumour immune response .
-BACKGROUND	We investigated the effect of serum from women undergoing primary breast cancer surgery , randomized to propofol-paravertebral block ( PPA ) or sevoflurane-opioid ( GA ) anaesthetic techniques , on healthy human donor NK cell function and cytotoxicity against oestrogen and progesterone receptor-positive breast cancer cells ( HCC1500 ) .
-METHODS	Ten subjects who donated serum before operation and 24 h after operation in an ongoing randomized prospective trial ( NCT 00418457 ) were randomly selected .
-METHODS	Serum from PPA ( n = 5 ) and GA ( n = 5 ) subjects was co-cultured with HCC1500 and healthy primary NK cells .
-METHODS	NK cell activating receptors ( NKp30 , NKp44 , NKp46 , 2b4 , CD16 , NKG2D ) , cytokine production , NK CD107a expression , and cytotoxicity towards HCC1500 were examined .
-RESULTS	Serum from PPA subjects did not alter normal NK marker expression or secretion of cytokines .
-RESULTS	Serum from GA subjects reduced NK cell activating receptor CD16 [ from mean ( sem ) , 82 ( 2 ) % to 50 ( 4 ) % , P = 0.001 ] , IL-10 [ from 1700 ( 80 ) to 1200 ( 92 ) pg ml ( -1 ) , P = 0.001 ] , and IL-1 [ from 68 ( 12 ) to 19 ( 4 ) pg ml ( -1 ) , P = 0.01 ] .
-RESULTS	An increase in NK cell CD107a [ 23 ( 2 ) % to 37 ( 3 ) % , P = 0.007 ] and apoptosis of HCC1500 [ 11 ( 1 ) % to 21 ( 2 ) % , P = 0.0001 ] was observed with PPA serum , but not GA serum , treated NK cells .
-CONCLUSIONS	Serum from women with breast cancer undergoing surgical excision who were randomized to receive a PPA anaesthetic technique led to greater human donor NK cell cytotoxicity in vitro compared with serum from women who received GA. .
-BACKGROUND	NCT 041857 .
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-###25284751
-BACKGROUND	In Korean medicine , the steamed root of Panax ginseng C.A. Meyer , known as Korean red ginseng ( KRG ) , is used to invigorate the body , enhance qi , and improve blood flow .
-BACKGROUND	It is a potential treatment for cold hypersensitivity in the hands and feet ( CHHF ) , a common complaint among Asians , especially women .
-BACKGROUND	However , few studies of its efficacy and safety for CHHF have been conducted .
-METHODS	This randomized , double-blind , placebo-controlled trial included 80 female patients with CHHF at Kyung Hee University Hospital at Gangdong , Seoul , Korea .
-METHODS	The participants took six capsules of 500-mg KRG powder or placebo twice daily for 8 weeks and were followed up for 4 weeks .
-METHODS	The primary outcome measure was change in skin temperature of the hands .
-METHODS	The secondary outcome measures included change in skin temperature of the feet , visual analog scale ( VAS ) scores of CHHF severity , recovered temperature ( RT ) of the hands after cold stress test , distal-dorsal difference ( DDD ) in temperature of the hands , power variables of heart rate variability ( HRV ) , and 36-item Short-Form Health Survey ( SF-36 ) scores .
-RESULTS	The KRG group had significantly higher skin temperature of the hands and feet , lower VAS scores , higher RT of the right 5th finger , and less parasympathetic activity than the placebo group at 8 weeks .
-RESULTS	No significant differences were noted in DDD of the hands and SF-36 scores .
-RESULTS	No serious adverse events were reported during the study .
-CONCLUSIONS	Peripheral vasodilation by KRG may alleviate CHHF .
-CONCLUSIONS	Further controlled studies are required to elucidate the effects of KRG on the autonomic nervous system .
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-###24583546
-OBJECTIVE	This work provides a reference for future papers originating from this study by providing basic results on body mass , urine volume , and hemodynamic changes to 5 days of bed rest ( BR ) and by describing acute cardio-respiratory/mechanographic responses to a short versatile upright exercise battery .
-METHODS	Ten male subjects ( mean SEM age : 29.4 1.5 years ; height : 178.8 1.5 cm ; body mass : 77.7 1.5 kg ) performed , in random order , 5 days of 6 head-down tilt ( HDT ) BR with no exercise ( CON ) , or BR with daily 25 minutes of quiet upright standing ( STA ) or upright locomotion replacement training ( LRT ) .
-RESULTS	Plasma volume , exercise capacity and orthostatic tolerance decreased similarly between interventions following 5 days of BR .
-RESULTS	Upright heart rate during LRT and STA increased throughout BR ; from 137 4 bpm to 146 4 bpm for LRT ( P < 0.01 ) ; and from 90 3 bpm to 102 6 bpm ( P < 0.001 ) for STA .
-CONCLUSIONS	the overall similarity in the response to BR , and increase in upright heart rate during the LRT sessions suggest early and advancing cardiovascular deconditioning during 5 days of BR bed rest , which was not prevented by the versatile exercise regime .
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-###25088860
-OBJECTIVE	The objective of the study was to determine whether transversus abdominis plane ( TAP ) block reduces postoperative pain when compared with trocar site infiltration of bupivacaine in gynecological laparoscopy .
-METHODS	This was a prospective , randomized , double-blinded clinical trial using patients as their own controls .
-METHODS	Women undergoing gynecologic laparoscopy using a 4-port symmetrical technique were randomly assigned to right - or left-sided TAP block using 30 mL of 0.25 % bupivacaine with epinephrine .
-METHODS	Two cohorts of patients were studied .
-METHODS	Cohort 1 consisted of anesthesiologist-administered ultrasound-guided TAP block .
-METHODS	Cohort 2 consisted of surgeon-administered laparoscopic-guided TAP block .
-METHODS	In both cohorts , contralateral port sites were infiltrated with an equal amount of bupivacaine in divided doses .
-METHODS	All patients received intraoperative acetaminophen and ketorolac .
-METHODS	Postoperative abdominal pain was assessed at 1 , 2 , 4 , 6 , 8 , 12 , 18 , 24 , and 48 hours on the block and contralateral sides , before and after palpation , using the 10 point visual analog scale .
-METHODS	A 2 point difference in the reported pain scores was considered clinically meaningful .
-RESULTS	Eighty-eight patients were eligible for statistical analysis : 45 and 43 patients in cohorts 1 and 2 , respectively .
-RESULTS	In both cohorts , most patients reported equal pain on the block side and local side .
-RESULTS	In cohort 1 , there was a statistically significant difference in mean reported pain scores at 2 hours and across time favoring the ultrasound-guided block ; however , this did not reach clinical significance .
-RESULTS	There was no statistically significant difference found at all other time points or when pain scores were objectively assessed after palpation of the incisions .
-RESULTS	When comparing laparoscopic-guided block with local infiltration , there was no statistically significant difference in reported mean pain scores at all time points or after palpation .
-CONCLUSIONS	As part of this multimodal analgesic regimen , neither block method provided a significant clinical benefit compared with trocar site bupivacaine infiltration .
-
-###24694530
-OBJECTIVE	The goal of this trial was to study the long-term effects of intravenous ( IV ) metoprolol administration before reperfusion on left ventricular ( LV ) function and clinical events .
-BACKGROUND	Early IV metoprolol during ST-segment elevation myocardial infarction ( STEMI ) has been shown to reduce infarct size when used in conjunction with primary percutaneous coronary intervention ( pPCI ) .
-METHODS	The METOCARD-CNIC ( Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction ) trial recruited 270 patients with Killip class II anterior STEMI presenting early after symptom onset ( < 6 h ) and randomized them to pre-reperfusion IV metoprolol or control group .
-METHODS	Long-term magnetic resonance imaging ( MRI ) was performed on 202 patients ( 101 per group ) 6 months after STEMI .
-METHODS	Patients had a minimal 12-month clinical follow-up .
-RESULTS	Left ventricular ejection fraction ( LVEF ) at the 6 months MRI was higher after IV metoprolol ( 48.7 9.9 % vs. 45.0 11.7 % in control subjects ; adjusted treatment effect 3.49 % ; 95 % confidence interval [ CI ] : 0.44 % to 6.55 % ; p = 0.025 ) .
-RESULTS	The occurrence of severely depressed LVEF ( 35 % ) at 6 months was significantly lower in patients treated with IV metoprolol ( 11 % vs. 27 % , p = 0.006 ) .
-RESULTS	The proportion of patients fulfilling Class I indications for an implantable cardioverter-defibrillator ( ICD ) was significantly lower in the IV metoprolol group ( 7 % vs. 20 % , p = 0.012 ) .
-RESULTS	At a median follow-up of 2 years , occurrence of the pre-specified composite of death , heart failure admission , reinfarction , and malignant arrhythmias was 10.8 % in the IV metoprolol group versus 18.3 % in the control group , adjusted hazard ratio ( HR ) : 0.55 ; 95 % CI : 0.26 to 1.04 ; p = 0.065 .
-RESULTS	Heart failure admission was significantly lower in the IV metoprolol group ( HR : 0.32 ; 95 % CI : 0.015 to 0.95 ; p = 0.046 ) .
-CONCLUSIONS	In patients with anterior Killip class II STEMI undergoing pPCI , early IV metoprolol before reperfusion resulted in higher long-term LVEF , reduced incidence of severe LV systolic dysfunction and ICD indications , and fewer heart failure admissions .
-CONCLUSIONS	( Effect of METOprolol in CARDioproteCtioN During an Acute Myocardial InfarCtion .
-CONCLUSIONS	The METOCARD-CNIC Trial ; NCT01311700 ) .
-
-###24918122
-OBJECTIVE	Few studies have examined consumer acceptability or comprehension of cholesterol-lowering claims on food labels .
-OBJECTIVE	Our objective was to assess consumer attitudes and understanding of cholesterol-lowering claims regarding plant sterols ( PS ) and oat fibre ( OF ) .
-METHODS	We conducted two studies on : ( 1 ) PS claims and ( 2 ) OF claims .
-METHODS	Both studies involved a randomized mock-packaged experiment within an online survey administered to Canadian consumers .
-METHODS	In the PS study ( n = 721 ) , we tested three PS-related claims ( disease risk reduction claim , function claim and nutrient content claim ) and a ` tastes great ' claim ( control ) on identical margarine containers .
-METHODS	Similarly , in the OF study ( n = 710 ) , we tested three claims related to OF and a ` taste great ' claim on identical cereal boxes .
-METHODS	In both studies , participants answered the same set of questions on attitudes and understanding of claims after seeing each mock package .
-RESULTS	All claims that mentioned either PS or OF resulted in more positive attitudes than the taste control claim ( P < 0.0001 ) , despite all products within each study having the same nutrition profile .
-RESULTS	How consumers responded to the nutrition claims between the two studies was influenced by contextual factors such as familiarity with the functional food/component and the food product that carried the claim .
-CONCLUSIONS	Permitted nutrition claims are approved based on physiological evidence and are allowed on any food product as long as it meets the associated nutrient criteria .
-CONCLUSIONS	However , it is difficult to generalize attitudes and understanding of claims when they are so highly dependent on contextual factors .
-
-###25102458
-OBJECTIVE	This randomised clinical trial ( RCT ) compared the clinical outcomes of three aesthetic full-coronal restorations ( composite strip crowns , pre-veneered stainless steel crowns ( SSCs ) and pre-fabricated primary zirconia crowns ) in carious and traumatised primary maxillary incisors .
-METHODS	One hundred and twenty nine teeth in 39 children aged between 3 to 5 years were included .
-METHODS	Children were randomly assigned to one of three treatment groups using a permuted block randomisation technique with a total of 43 teeth in each group .
-METHODS	After trainee calibration , restorations were placed and evaluated after 6 months .
-METHODS	Outcomes evaluated were restoration failure , tooth wear of opposing teeth and gingival health .
-RESULTS	The retention rate was highest for zirconia crowns ( 100 % ) followed by pre-veneered SSCs ( 95 % ) .
-RESULTS	Strip crowns were the least retentive ( 78 % ) .
-RESULTS	Zirconia crowns showed low grade abrasion in four opposing teeth .
-RESULTS	Teeth restored with resin composite and pre-veneered SSC showed an increase in mean gingival index score , while corresponding values decreased in zirconia crowns .
-CONCLUSIONS	Resin composite strip crown is a highly sensitive technique leading to lower retention rate .
-CONCLUSIONS	Pre-veneered stainless steel crowns showed increased incidence of facial veneer fracture .
-CONCLUSIONS	Zirconia crowns are highly retentive and biocompatible but cause low grade of abrasion of their opposing natural dentition at the 6-month follow-up .
-
-###25041182
-OBJECTIVE	To evaluate the clinical , microbiological and immunological effects of systemic doxycycline as an adjunct to scaling and root planing ( SRP ) in chronic periodontitis patients with well-controlled type 2 diabetes .
-METHODS	Sixty-six patients compliant to oral hygiene ( Hygiene Index < 20 % ) allocated to either a test ( systemic doxycycline for 21 days ) or a control ( placebo ) group participated in the present randomized controlled trial ( RCT ) .
-METHODS	Clinical assessments were recorded at baseline , 3 and 6 months after therapy and included clinical attachment level ( CAL ) , set as the primary outcome of the study , probing pocket depth ( PPD ) , recession ( RE ) and bleeding on probing ( BOP ) .
-METHODS	At the same time points , counts of 15 subgingival species were evaluated by `` checkerboard '' DNA-DNA hybridization , gingival crevicular fluid samples were analysed for matrix metalloproteinase-8 ( MMP-8 ) by ELISA and HbA1c levels were determined .
-METHODS	Comparisons between and within groups were performed by non-parametric tests ( Mann-Whitney , Wilcoxon signed-ranks and z-test for proportions with Bonferroni corrections ) at the 0.05 level .
-RESULTS	No major differences were noticed in clinical and microbiological parameters of periodontal disease or levels of MMP-8 between the two groups .
-CONCLUSIONS	Adjunctive systemic doxycycline does not seem to significantly enhance the effects of SRP in well-controlled diabetes type 2 patients .
-
-###25242051
-BACKGROUND	Disproportionally low retention of minority populations can adversely affect the generalizability of clinical research trials .
-BACKGROUND	We determine the overall retention rates for White and Black participants from the Selenium and Vitamin E Cancer Prevention Trial ( SELECT ) and explore participant and site characteristics associated with retention failure ( study disengagement ) for these groups .
-METHODS	A secondary analysis of 28,118 White ( age 55 ) , and 4,322 Black ( age 50 ) SELECT participants used multivariate Cox regression to estimate overall retention rates and to calculate HRs and 95 % confidence intervals ( CI ) .
-RESULTS	Blacks had higher age-adjusted risk of disengagement than Whites ( HR , 1.92 ; 95 % CI , 1.77-2 .08 ) .
-RESULTS	Among Black participants , those ages 50 to 54 were at three times the risk of disengagement than those 65 years of age ( HR , 3.61 ; 95 % CI , 2.41-5 .41 ) .
-RESULTS	Blacks age 65 had 1.6 times the risk of disengagement than Whites age 65 ( HR , 1.60 ; 95 % CI , 1.38-1 .87 ) .
-RESULTS	By 6 years after randomization , 84 % of Whites and 69 % of Blacks remained engaged in the study .
-RESULTS	Current smoking status was an independent risk factor for study disengagement for both White and Black participants .
-RESULTS	For both groups , sites whose staffs missed SELECT training sessions or who received SELECT Retention and Adherence grants were associated with increased and decreased disengagement risks , respectively .
-CONCLUSIONS	SELECT retention was disproportionately lower for Blacks than for Whites .
-CONCLUSIONS	The observed difference in retention rates for Blacks and Whites and factors identified by race for study disengagement in SELECT may inform retention efforts for future long-term , cancer prevention trials .
-
-###25769361
-BACKGROUND	New oral anticoagulants for stroke prevention in atrial fibrillation were developed to be given in fixed doses without the need for the routine monitoring that has hindered usage and acceptance of vitamin K antagonists .
-BACKGROUND	A concern has emerged , however , that measurement of drug concentration or anticoagulant activity might be needed to prevent excess drug concentrations , which significantly increase bleeding risk .
-BACKGROUND	In the ENGAGE AF-TIMI 48 trial , higher-dose and lower-dose edoxaban were compared with warfarin in patients with atrial fibrillation .
-BACKGROUND	Each regimen incorporated a 50 % dose reduction in patients with clinical features known to increase edoxaban drug exposure .
-BACKGROUND	We aim to assess whether adjustment of edoxaban dose in this trial prevented excess drug concentration and the risk of bleeding events .
-METHODS	We analysed data from the randomised , double-blind ENGAGE AF-TIMI 48 trial .
-METHODS	We correlated edoxaban dose , plasma concentration , and anti-Factor Xa ( FXa ) activity and compared efficacy and safety outcomes with warfarin stratified by dose reduction status .
-METHODS	Patients with atrial fibrillation and at moderate to high risk of stroke were randomly assigned in a 1:1:1 ratio to receive warfarin , dose adjusted to an international normalised ratio of 20-30 , higher-dose edoxaban ( 60 mg once daily ) , or lower-dose edoxaban ( 30 mg once daily ) .
-METHODS	Randomisation was done with use of a central , 24 h , interactive , computerised response system .
-METHODS	International normalised ratio was measured using an encrypted point-of-care device .
-METHODS	To maintain masking , sham international normalised ratio values were generated for patients assigned to edoxaban .
-METHODS	Edoxaban ( or placebo-edoxaban in warfarin group ) doses were halved at randomisation or during the trial if patients had creatinine clearance 30-50 mL/min , bodyweight 60 kg or less , or concomitant medication with potent P-glycoprotein interaction .
-METHODS	Efficacy outcomes included the primary endpoint of all-cause stroke or systemic embolism , ischaemic stroke , and all-cause mortality .
-METHODS	Safety outcomes included the primary safety endpoint of major bleeding , fatal bleeding , intracranial haemorrhage , and gastrointestinal bleeding .
-METHODS	This trial is registered with ClinicalTrials.gov , number NCT00781391 .
-RESULTS	Between Nov 19 , 2008 and Nov 22 , 2010 , 21105 patients were recruited .
-RESULTS	Patients who met clinical criteria for dose reduction at randomisation ( n = 5356 ) had higher rates of stroke , bleeding , and death compared with those who did not have a dose reduction ( n = 15749 ) .
-RESULTS	Edoxaban dose ranged from 15 mg to 60 mg , resulting in a two-fold to three fold gradient of mean trough drug exposure ( 160-485 ng/mL in 6780 patients with data available ) and mean trough anti-FXa activity ( 035-085 IU/mL in 2865 patients ) .
-RESULTS	Dose reduction decreased mean exposure by 29 % ( from 485 ng/mL [ SD 458 ] to 346 ng/mL [ 309 ] ) and 35 % ( from 245 ng/mL [ 227 ] to 160 ng/mL [ 145 ] ) and mean anti-FXa activity by 25 % ( from 085 IU/mL [ 076 ] to 064 IU/mL [ 054 ] ) and 20 % ( from 044 IU/mL [ 037 ] to 035 IU/mL [ 028 ] ) in the higher-dose and lower-dose regimens , respectively .
-RESULTS	Despite the lower anti-FXa activity , dose reduction preserved the efficacy of edoxaban compared with warfarin ( stroke or systemic embolic event : higher dose pinteraction = 085 , lower dose pinteraction = 099 ) and provided even greater safety ( major bleeding : higher dose pinteraction 002 , lower dose pinteraction = 0002 ) .
-CONCLUSIONS	These findings validate the strategy that tailoring of the dose of edoxaban on the basis of clinical factors alone achieves the dual goal of preventing excess drug concentrations and helps to optimise an individual patient 's risk of ischaemic and bleeding events and show that the therapeutic window for edoxaban is narrower for major bleeding than thromboembolism .
-BACKGROUND	Daiichi-Sankyo Pharma Development .
-
-###25970009
-BACKGROUND	Financial incentives promote many health behaviors , but effective ways to deliver health incentives remain uncertain .
-METHODS	We randomly assigned CVS Caremark employees and their relatives and friends to one of four incentive programs or to usual care for smoking cessation .
-METHODS	Two of the incentive programs targeted individuals , and two targeted groups of six participants .
-METHODS	One of the individual-oriented programs and one of the group-oriented programs entailed rewards of approximately $ 800 for smoking cessation ; the others entailed refundable deposits of $ 150 plus $ 650 in reward payments for successful participants .
-METHODS	Usual care included informational resources and free smoking-cessation aids .
-RESULTS	Overall , 2538 participants were enrolled .
-RESULTS	Of those assigned to reward-based programs , 90.0 % accepted the assignment , as compared with 13.7 % of those assigned to deposit-based programs ( P < 0.001 ) .
-RESULTS	In intention-to-treat analyses , rates of sustained abstinence from smoking through 6 months were higher with each of the four incentive programs ( range , 9.4 to 16.0 % ) than with usual care ( 6.0 % ) ( P < 0.05 for all comparisons ) ; the superiority of reward-based programs was sustained through 12 months .
-RESULTS	Group-oriented and individual-oriented programs were associated with similar 6-month abstinence rates ( 13.7 % and 12.1 % , respectively ; P = 0.29 ) .
-RESULTS	Reward-based programs were associated with higher abstinence rates than deposit-based programs ( 15.7 % vs. 10.2 % , P < 0.001 ) .
-RESULTS	However , in instrumental-variable analyses that accounted for differential acceptance , the rate of abstinence at 6 months was 13.2 percentage points ( 95 % confidence interval , 3.1 to 22.8 ) higher in the deposit-based programs than in the reward-based programs among the estimated 13.7 % of the participants who would accept participation in either type of program .
-CONCLUSIONS	Reward-based programs were much more commonly accepted than deposit-based programs , leading to higher rates of sustained abstinence from smoking .
-CONCLUSIONS	Group-oriented incentive programs were no more effective than individual-oriented programs .
-CONCLUSIONS	( Funded by the National Institutes of Health and CVS Caremark ; ClinicalTrials.gov number , NCT01526265 . )
-
-###25460174
-BACKGROUND	Time-dependent variability of electrocardiogram ( ECG ) in patients with Brugada syndrome could affect the interpretation of provocative testing .
-OBJECTIVE	The aim of this study was to characterize ECG changes during and after flecainide infusion .
-METHODS	We studied 59 consecutive patients .
-METHODS	The ECG was continuously analyzed during the first 30 minutes of provocative testing , and a single ECG was recorded 60 minutes later .
-METHODS	We analyzed CYP2D6 and CYP3A5 variants affecting flecainide metabolism and performed blinded measurements at lead II .
-RESULTS	At baseline , ECG patterns were classified as follows : type II in 31 patients ( 53 % ) , type III in 15 ( 25 % ) , and normal ECG in 13 ( 22 % ) .
-RESULTS	Because of induction of type I ECG , the percentage of responders progressively increased with longer recording time periods ( 6.8 % in 10 minutes vs 11.9 % in 20-30 minutes vs 18.6 % in 90 minutes ; P < .01 ) .
-RESULTS	Four patients displayed a late response , which was evidenced 90 minutes after the initiation of provocative testing .
-RESULTS	QRS width differentially increased between responders and nonresponders ( P < .01 ) , with a maximum QRS width of 110 ms during the first 30 minutes being effective for identifying possible late responders ( sensitivity 100 % ; specificity 85.6 % ; positive predictive value 88 % ; negative predictive value 100 % ) .
-RESULTS	The incidence of CYP2D6 variants was lower in late responders than in early or delayed responders ( 0 % vs 75 % vs 100 % ; P = .04 ) , while a homogeneous distribution of CYP3A5 * 3 / * 3 was observed in our population .
-CONCLUSIONS	Response to flecainide exhibits time-dependent variability of ECG patterns and intervals .
-CONCLUSIONS	Longer periods of ECG recording increase the recognition probability of type I ECG .
-
-###25738668
-BACKGROUND	Ovarian failure is a common toxic effect of chemotherapy .
-BACKGROUND	Studies of the use of gonadotropin-releasing hormone ( GnRH ) agonists to protect ovarian function have shown mixed results and lack data on pregnancy outcomes .
-METHODS	We randomly assigned 257 premenopausal women with operable hormone-receptor-negative breast cancer to receive standard chemotherapy with the GnRH agonist goserelin ( goserelin group ) or standard chemotherapy without goserelin ( chemotherapy-alone group ) .
-METHODS	The primary study end point was the rate of ovarian failure at 2 years , with ovarian failure defined as the absence of menses in the preceding 6 months and levels of follicle-stimulating hormone ( FSH ) in the postmenopausal range .
-METHODS	Rates were compared with the use of conditional logistic regression .
-METHODS	Secondary end points included pregnancy outcomes and disease-free and overall survival .
-RESULTS	At baseline , 218 patients were eligible and could be evaluated .
-RESULTS	Among 135 with complete primary end-point data , the ovarian failure rate was 8 % in the goserelin group and 22 % in the chemotherapy-alone group ( odds ratio , 0.30 ; 95 % confidence interval [ CI ] , 0.09 to 0.97 ; two-sided P = 0.04 ) .
-RESULTS	Owing to missing primary end-point data , sensitivity analyses were performed , and the results were consistent with the main findings .
-RESULTS	Missing data did not differ according to treatment group or according to the stratification factors of age and planned chemotherapy regimen .
-RESULTS	Among the 218 patients who could be evaluated , pregnancy occurred in more women in the goserelin group than in the chemotherapy-alone group ( 21 % vs. 11 % , P = 0.03 ) ; women in the goserelin group also had improved disease-free survival ( P = 0.04 ) and overall survival ( P = 0.05 ) .
-CONCLUSIONS	Although missing data weaken interpretation of the findings , administration of goserelin with chemotherapy appeared to protect against ovarian failure , reducing the risk of early menopause and improving prospects for fertility .
-CONCLUSIONS	( Funded by the National Cancer Institute and others ; POEMS/S0230 ClinicalTrials.gov number , NCT00068601 . )
-
-###25968407
-OBJECTIVE	Statins exert pleiotropic effects that result in cardioprotective and antiinflammatory properties .
-OBJECTIVE	There is a lack of information about the effect of preoperative reloading statin administration in surgical coronary patients regarding myocardial protection , systemic inflammatory response ( SIR ) attenuation and nitric oxide ( NO ) metabolism .
-METHODS	Thirty consecutive dyslipidemic patients under chronic treatment with statins were randomized to orally receive pravastatin 80 mg ( N. = 10 ) , 40 mg ( N. = 10 ) or placebo ( N. = 10 ) two hours before anesthetic induction for non-emergent on-pump coronary artery bypass grafting ( CABG ) procedures .
-METHODS	Perioperative peripheral venous and intraoperative CS blood samples were collected for determination of drug-related adverse effects , NO metabolism and both myocardial damage and SIR biomarkers .
-RESULTS	Pravastatin reloading resulted in a significant and dose-related intense attenuation of SIR , but no differences in cardiac damage biomarker levels were demonstrated .
-RESULTS	NO release and inducible nitric oxide synthase expression was significantly reduced in both treatment groups .
-RESULTS	Highest pravastatin doses significantly increased systemic creatine phosphokinase ( CPK ) concentration compared with intermediate doses but no other adverse effects were observed .
-CONCLUSIONS	Oral pravastatin reloading before non-emergent CABG significantly attenuates postoperative SIR and systemic NO/iNOS concentrations with no effect in perioperative myocardial damage .
-CONCLUSIONS	Highest pravastatin doses increase CPK levels and must be avoided in susceptible patients .
-
-###24526592
-BACKGROUND	Hernioplasty is one of the most frequent surgeries in the UK .
-BACKGROUND	Light-weight mesh ( LWM ) has the potential to reduce chronic groin pain but its cost-effectiveness compared with heavy-weight mesh ( HWM ) is unknown .
-OBJECTIVE	Our objective was to conduct a cost-utility analysis between laparoscopic hernioplasty with HWM and LWM for unilateral inguinal hernias .
-METHODS	A Markov model simulated costs and health outcomes over a period of 1year ( 2012 ) from the societal and National Health Service ( NHS ) perspective ( England ) .
-METHODS	The main outcome was cost per quality-adjusted life-year ( QALY ) gained .
-METHODS	Surgery results were gleaned from the randomized control trial by Bittner et al. .
-METHODS	Other input parameters were drawn from the literature and public sources of the NHS .
-RESULTS	From the societal perspective , LWM induces lower incremental costs ( -88.85 ) than HWM but yields a slightly smaller incremental effect ( -0.00094 QALYs ) .
-RESULTS	The deterministic incremental cost-effectiveness ratio ( ICER ) for HWM compared with LWM amounts to 94,899 per QALY , while the probabilistic ICER is 118,750 ( 95 % confidence interval [ CI ] 57,603-180 ,920 ) .
-RESULTS	Owing to the withdrawal of productivity losses from the NHS perspective , LWM causes higher incremental costs ( 13.09 ) and an inferior incremental effect ( -0.00093 ) , resulting in a dominance of HWM over LWM ( ICER 95 % CI -12,382 to -21,590 ) .
-CONCLUSIONS	There is no support for the adoption of LWM as standard treatment from an NHS perspective .
-CONCLUSIONS	However , given the small differences between HWM and LWM , LWM has at least the potential of improving patient outcomes and reducing expenditure from the societal perspective .
-
-###25876351
-OBJECTIVE	With functional magnetic resonance imaging ( fMRI ) , cerebral function imaging of acupuncture and sham acupuncture at Taichong ( LR 3 ) in patients with essential hypertension ( EH ) was observed to analyze central mechanism of Taichong ( LR 3 ) to treat EH .
-METHODS	Eighteen EH patients were divided into a twisting acupuncture group ( 10 cases ) and a sham acupuncture group ( 8 cases ) , which were treated with twisting manipulation and sham acu - puncture at right Taichong ( LR 3 ) , respectively .
-METHODS	The treatments were both given with 30-second manipulation and 30 - second interval for totally 5 min .
-METHODS	During the acupuncture , fMRI was adopted to scan the cerebral function imaging of EH patients on resting state , and the acquired data were analyzed with SPM2 module in Matlab software .
-RESULTS	Acupunc - ture at Taichong ( LR 3 ) in EH patients mainly increased opposite-side oxygen consumption , which generally activated left anterior cingulated gyrus ( BA 32 ) , left inferior parietal lobule ( BA 40 ) , left inferior temporal gyrus ( BA 19 ) , left middle temporal gyrus ( BA 37 ) and right anterior central gyrus ( BA 6 ) .
-RESULTS	The activated areas were related to motor , vision and cognition of emotion .
-RESULTS	Stimulation region of sham acupuncture mainly included right anterior cingulated gyrus ( BA 24 ) , left inferior parietal lobule ( BA 40 ) and left inferior frontal gyrus ( BA 7 ) .
-CONCLUSIONS	The central mechanism of Tai - chong ( LR 3 ) on antihypertensive effect and symptom improvement is not in thalamus and medulla that are traditionally believed to control blood pressure .
-CONCLUSIONS	Taichong ( LR 3 ) could activate anterior cingulated gyrus to regulate parasympathetic nerve and lower blood pressure , and through anterior cingulated gyrus , the connection with the surrounding areas is strengthened to improve the cognitive impairment caused by long-term hypertension .
-
-###25055027
-BACKGROUND	The aim of the study was to objectively determine whether the Nutrition and Physical Activity Self-Assessment for Child Care ( NAP SACC ) program improved physical activity levels during the school day .
-METHODS	The study compared the physical activity levels of subjects from 26 daycare centers , randomized into treatment ( N = 13 ) and control ( N = 13 ) groups .
-METHODS	The subjects were 3 to 5 year olds ( N = 209 , 104 males and 105 females ; age [ years ] = 3.850.8 [ meanstandard deviation ] ) , and accelerometry was used to determine the subjects ' physical activity levels .
-METHODS	Accelerometers were attached to each subject for 2 days before and immediately after a 6-month intervention .
-METHODS	Height , mass , and waist were also measured .
-RESULTS	Regression analyses indicated that the treatment group demonstrated significant increases in moderate and vigorous physical activity , as compared to the control group ( F ( 1 , 207 ) = 6.3 , p < 0.05 , Cohen 's d = 0.30 ; F ( 1 , 207 ) = 4.7 , p < 0.05 , Cohen 's d = 0.25 , respectively ) .
-RESULTS	The treatment group also showed significant increases in total physical activity ( F ( 1 , 218 ) = 12.4 ; p < 0.05 ) from pre - to post-test with significant increases in moderate and vigorous intensity physical activity ( F ( 1 , 218 ) = 18.6 , p < 0.05 ; F ( 1 , 218 ) = 23.3 , p < 0.05 , respectively ) .
-RESULTS	Regression analyses revealed significant increases in height for both groups from pre - to post-tests , but no differences were noted between groups .
-CONCLUSIONS	Implementation of the NAP SACC program in treatment daycare facilities resulted in significant increases in objectively measured physical activity levels , compared to the control group , demonstrating physical activity improvement in the treatment daycare centers .
-
-###24417710
-OBJECTIVE	Previous validation studies assessing the use of administrative data to identify patients with epilepsy have used targeted sampling or have used a reference standard of patients in the neurologist , hospital , or emergency room setting .
-OBJECTIVE	Therefore , the validity of using administrative data to identify patients with epilepsy in the general population has not been previously assessed .
-OBJECTIVE	The purpose of this study was to determine the validity of using administrative data to identify patients with epilepsy in the general population .
-METHODS	A retrospective chart abstraction study was performed using primary care physician records from 83 physicians distributed throughout Ontario and contributing data to the Electronic Medical Record Administrative data Linked Database ( EMRALD ) A random sample of 7,500 adult patients , from a possible 73,014 eligible , was manually chart abstracted to identify patients who had ever had epilepsy .
-METHODS	These patients were used as a reference standard to test a variety of administrative data algorithms .
-RESULTS	An algorithm of three physician billing codes ( separated by at least 30days ) in 2years or one hospitalization had a sensitivity of 73.7 % ( 95 % confidence interval [ CI ] 64.8-82 .5 % ) , specificity of 99.8 % ( 95 % CI 99.6-99 .9 % ) , positive predictive value ( PPV ) of 79.5 % ( 95 % CI71.1-88 .0 % ) , and negative predictive value ( NPV ) of 99.7 % ( 95 % CI99.5-99 .8 % ) for identifying patients who had ever had epilepsy .
-CONCLUSIONS	The results of our study showed that administrative data can reasonably accurately identify patients who have ever had epilepsy , allowing for a `` lifetime '' population prevalence determination of epilepsy in Ontario and the rest of Canada with similar administrative databases .
-CONCLUSIONS	This will facilitate future studies on population level patterns and outcomes of care for patients living with epilepsy .
-
-###24499493
-OBJECTIVE	The application of - adrenoceptor agonists can improve faecal incontinence symptoms .
-OBJECTIVE	The aim of this study was to investigate the pharmacokinetic and systemic effects of NRL001 administered as different strengths in 1 or 2 g suppositories .
-METHODS	This randomised , double-blind , placebo controlled study included 48 healthy subjects .
-METHODS	Group 1 consisted of two cohorts of 12 subjects administered either four single doses of 1 or 2 g rectal suppository with either 5 , 7.5 or 10 mg NRL001 , or matching placebo .
-METHODS	Group 2 consisted of two cohorts of 12 subjects administered either four single doses of 1 or 2 g rectal suppository with either 10 , 12.5 or 15 mg NRL001 , or matching placebo .
-METHODS	Doses were given in an escalating manner with placebo at a random position within the sequence .
-RESULTS	Tmax was at ~ 4.5 h post-dose for all NRL001 doses .
-RESULTS	Median AUC0-tz , AUC0 - and Cmax increased with increasing dose for both suppository sizes .
-RESULTS	The estimate of ratios of geometric means comparing 2 g with 1 g suppository , and regression analysis for dose proportionality , was close to 1 for the variables AUC0-tz , AUC0 - and Cmax ( P > 0.05 ) .
-RESULTS	For both suppository sizes , 20-min mean pulse rate was significantly decreased compared with placebo with all doses ( P < 0.05 ) .
-RESULTS	Blood pressure decreased overall .
-RESULTS	There were 144 adverse events ( AEs ) and no serious AEs reported during the study .
-RESULTS	All AEs were mild in severity .
-CONCLUSIONS	The regression analysis concluded that the doses were dose proportional .
-
-###25828372
-BACKGROUND	Results of regular drug-eluting stents ( rDESs ) in bifurcation treatment are not optimal .
-BACKGROUND	The aim of the Polish Bifurcation Optimal Stenting I ( POLBOS I ) trial was to compare bifurcation treatment with any rDES vs the dedicated bifurcation paclitaxel-eluting stent BiOSS Expert ( Balton , Poland ) .
-BACKGROUND	The second aim was to study the effect of final kissing balloon ( FKB ) inflation on clinical outcomes .
-METHODS	Between October 2010 and January 2013 patients with stable coronary artery disease or non-ST-elevation acute coronary syndrome were assigned 1:1 to 1 of 2 treatment strategies : BiOSS Expert stent or rDES implantation .
-METHODS	Coronary angiography was performed at 12 months .
-METHODS	The primary end point was a composite of cardiac-related death , myocardial infarction ( MI ) , and target lesion revascularization ( TLR ) at 12 months .
-RESULTS	The BiOSS Expert was implanted in 120 patients ( 49.4 % ) , and an rDES was implanted in 123 patients .
-RESULTS	The target vessel was the left anterior descending ( LAD ) artery ( 52 % vs 70 % ) followed by the left main stem ( LMS ) coronary artery ( 22 % vs 15 % ) .
-RESULTS	In the rDES group , 38.2 % received paclitaxel-eluting stents .
-RESULTS	There were 3 stent implantation failures ( 2 in the rDES group and 1 in the BiOSS Expert group ) .
-RESULTS	Side branch treatment with an rDES was required in 10 % of cases in both groups .
-RESULTS	At 12 months , the incidence of cumulative major adverse cardiovascular events ( MACE ) was similar in both groups : 13.3 % vs 12.2 % ( P = 0.7 ) .
-RESULTS	The TLR rate was significantly higher in the BiOSS Expert group compared with the rDES group ( 11.5 % vs 7.3 % ; P = 0.02 ) .
-RESULTS	Significantly lower rates of restenosis were observed in FKB subgroups of both the BiOSS Expert ( 8.1 % vs 13.2 % ; P < 0.05 ) and rDES groups ( 4.9 % vs 9.5 % ; P < 0.05 ) .
-CONCLUSIONS	MACE rates were comparable between the 2 groups ; however , the TLR rate was higher in the BiOSS Expert group .
-CONCLUSIONS	A more aggressive protocol yielded better angiographic and clinical outcomes .
-
-###25230136
-OBJECTIVE	A hybrid knife was recently developed to allow waterjet-assisted endoscopic submucosal dissection , which aims to speed up and simplify the procedure .
-OBJECTIVE	This technique has been shown to be effective and safe for the treatment of early gastric cancer ( EGC ) but it has not yet been compared with conventional ESD .
-METHODS	In this two-center study , patients with an endoscopic and histopathological diagnosis of gastric adenoma or early gastric adenocarcinoma ( meeting the extended Japanese criteria for local resection ) were randomized to either conventional or waterjet-assisted ESD .
-METHODS	The choice of knife was left to the endoscopist in the conventional group whereas the hybrid knife was used in the waterjet group.The primary end point was procedure time , and secondary outcomes included rates of en bloc resection , R0 resection , and complications .
-RESULTS	A total of 117 patients ( mean age 63.0 10.6 years , 76 men ) were randomized to either conventional ESD ( n = 59 ; control group ) or waterjet-assisted ESD ( n = 58 ) .
-RESULTS	There were no significant differences in patient demographics or lesion features between the groups .
-RESULTS	The mean procedure time was significantly shorter in the waterjet group compared with the conventional group ( 27.5 30.6 vs. 35.0 22.5 minutes ; P = 0.0008 ) , and a change of accessories was less frequently required ( mean number of changes 1.4 2.0 vs. 23.0 15.4 ; P < 0.0001 ) .
-RESULTS	There was no significant difference between the groups in the size of resected specimen , R0 resection rates , number of perforations , major delayed bleedings , or rates of complete remission of neoplasia after 3 months .
-CONCLUSIONS	Waterjet-assisted ESD and conventional ESD are comparably effective and safe techniques for the local treatment of EGC .
-CONCLUSIONS	The waterjet-assisted technique is a faster and simpler procedure and requires fewer accessory changes compared with conventional ESD .
-
-###25233644
-OBJECTIVE	To verify the clinical efficacy on post-stroke dysphagia treated with acupuncture at Lianquan ( CV 23 ) .
-METHODS	One hundred and eighty patients were randomized into an acupuncture A group , an acupuncture B group and a rehabilitation group , 60 cases in each one .
-METHODS	On the basis of the conventional medication , in the acupuncture A group , acupuncture was applied at Lianquan ( CV 23 ) ; in the acupuncture B group , acupuncture was applied at Hegu ( LI 4 ) and Neiguan ( PC 6 ) and in the rehabilitation group , the swallowing rehabilitation training was adopted .
-METHODS	The treatment was given once a day , 5 times a week , and the 4 weeks of treatment was required in all of the groups .
-METHODS	The national institute of health stroke scale ( NIHSS ) and TV X-ray fluoroscope swallowing scale ( VFSS ) were used to evaluate neurologic deficit and swallowing function before and after treatment in the patients of each group .
-METHODS	The morbidity of pneumonia and clinical efficacy were compared among the groups .
-RESULTS	The scores of NIHSS and VFSS were improved apparently after treatment in the patients of the three groups ( all P < 0.05 ) and the results in the acupuncture A group were superior to those in the other two groups ( all P < 0.05 ) .
-RESULTS	The morbidity of pneumonia in the acupuncture A group was lower than that in the acupuncture B group and the rehabilitation group [ 3.3 % ( 2/60 ) vs 6.7 % ( 4/60 ) , 8.3 % ( 5/60 ) , both P < 0.05 ] .
-RESULTS	The effective rate in the acupuncture A group was better than that in either of the other two groups [ 95.0 % ( 57/60 ) vs 81.7 % ( 49 / 60 ) , 75.0 % ( 45/60 ) , both P < 0.05 ] .
-CONCLUSIONS	On the basis of the conventional medication , acupuncture at Lianquan ( CV 23 ) effectively improves the swallowing function , relieves neurological deficit and reduces the morbidity of pneumonia in the patients of post-stroke dysphagia .
-
-###25316904
-BACKGROUND	Little evidence exists on the effect of an energy-unrestricted healthy diet on metabolic syndrome .
-BACKGROUND	We evaluated the long-term effect of Mediterranean diets ad libitum on the incidence or reversion of metabolic syndrome .
-METHODS	We performed a secondary analysis of the PREDIMED trial -- a multicentre , randomized trial done between October 2003 and December 2010 that involved men and women ( age 55-80 yr ) at high risk for cardiovascular disease .
-METHODS	Participants were randomly assigned to 1 of 3 dietary interventions : a Mediterranean diet supplemented with extra-virgin olive oil , a Mediterranean diet supplemented with nuts or advice on following a low-fat diet ( the control group ) .
-METHODS	The interventions did not include increased physical activity or weight loss as a goal .
-METHODS	We analyzed available data from 5801 participants .
-METHODS	We determined the effect of diet on incidence and reversion of metabolic syndrome using Cox regression analysis to calculate hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) .
-RESULTS	Over 4.8 years of follow-up , metabolic syndrome developed in 960 ( 50.0 % ) of the 1919 participants who did not have the condition at baseline .
-RESULTS	The risk of developing metabolic syndrome did not differ between participants assigned to the control diet and those assigned to either of the Mediterranean diets ( control v. olive oil HR 1.10 , 95 % CI 0.94-1 .30 , p = 0.231 ; control v. nuts HR 1.08 , 95 % CI 0.92-1 .27 , p = 0.3 ) .
-RESULTS	Reversion occurred in 958 ( 28.2 % ) of the 3392 participants who had metabolic syndrome at baseline .
-RESULTS	Compared with the control group , participants on either Mediterranean diet were more likely to undergo reversion ( control v. olive oil HR 1.35 , 95 % CI 1.15-1 .58 , p < 0.001 ; control v. nuts HR 1.28 , 95 % CI 1.08-1 .51 , p < 0.001 ) .
-RESULTS	Participants in the group receiving olive oil supplementation showed significant decreases in both central obesity and high fasting glucose ( p = 0.02 ) ; participants in the group supplemented with nuts showed a significant decrease in central obesity .
-CONCLUSIONS	A Mediterranean diet supplemented with either extra virgin olive oil or nuts is not associated with the onset of metabolic syndrome , but such diets are more likely to cause reversion of the condition .
-CONCLUSIONS	An energy-unrestricted Mediterranean diet may be useful in reducing the risks of central obesity and hyperglycemia in people at high risk of cardiovascular disease .
-BACKGROUND	ClinicalTrials.gov , no .
-BACKGROUND	ISRCTN35739639 .
-
-###24696010
-OBJECTIVE	Topical corticosteroids are the current first-line therapy for vulvar lichen sclerosus ( VLS ) .
-OBJECTIVE	UV-A1 phototherapy may be a promising alternative treatment option , but controlled studies are lacking .
-OBJECTIVE	To compare the efficacy of high-potent topical corticosteroids with UV-A1 phototherapy in the treatment of VLS .
-METHODS	A 2-arm randomized clinical trial was conducted at a university hospital dermatology department according to the intention-to-treat principle with last observation carried forward .
-METHODS	The study population comprised 30 female patients with VLS .
-METHODS	Treatment of VLS with clobetasol propionate , 0.05 % , ointment applied once daily for 3 months or medium-dose UV-A1 ( 50 J/cm ) home-based phototherapy , performed 4 times weekly for 3 months .
-METHODS	Mean relative reduction of the total clinician 's score ( TCS ) was considered the primary outcome measure .
-METHODS	Secondary outcome measures included the reduction of pruritus and burning and/or pain according to a visual analog scale ( VAS ) , a health-related quality of life score ( Skindex-29 ) , 20-MHz ultrasonography , and histopathological analysis before and after 3 months of therapy .
-RESULTS	Fifteen patients were randomized in each treatment arm , and 2 patients dropped out in both treatment arms .
-RESULTS	After therapy , both therapies resulted in a significant decrease in mean TCS ( 51.4 % [ 95 % CI , 39.7 % to 63.0 % ] for clobetasol ointment [ P < .001 ] and 35.6 % [ 95 % CI , 18.2 % to 53.1 % ] for UV-A1 phototherapy [ P = .006 ] ) .
-RESULTS	No significant difference was found between both treatments ( P > .05 ) .
-RESULTS	The Skindex-29 ( mean difference [ MD ] , 29.6 [ 95 % CI , 7.9 to 51.2 ] [ P = .009 ] ) and the VAS score for pruritus ( MD , 4.6 [ 95 % CI , 1.5 to 7.7 ] [ P = .005 ] ) and burning and/or pain ( MD , 4.2 [ 95 % CI , 1.9 to 6.6 ] [ P = .001 ] ) significantly decreased after clobetasol treatment .
-RESULTS	After UV-A1 phototherapy , the VAS score for burning and/or pain ( MD , 3.2 [ 95 % CI , 0.7 to 5.7 ] [ P = .01 ] ) was also significantly reduced ; however , there was no significant reduction in pruritus ( MD , 2.1 [ 95 % CI , 0.5 to 3.7 ] [ P = .16 ] ) and in the Skindex-29 score ( MD , 4.9 [ 95 % CI , -12.6 to 22.4 ] [ P > .99 ] ) .
-RESULTS	A significant reduction of the corium thickness and a significant increase in dermal density in 20-MHz ultrasonography as well as significant histopathological reduction of the inflammatory infiltrate was observed after clobetasol treatment but not after UV-A1 phototherapy .
-CONCLUSIONS	Although resulting in a significant clinical improvement , UV-A1 phototherapy was inferior to the current gold standard treatment with topical high-potent corticosteroids with respect to practicability , relief of itch , and improvement in quality of life .
-CONCLUSIONS	UV-A1 phototherapy may be considered a potential second-line treatment for VLS .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01400022 .
-
-###24282495
-BACKGROUND	Compulsory admission to psychiatric hospitals may be distressing , disruptive to patients and families , and associated with considerable cost to the health service .
-BACKGROUND	Improved patient experience and cost reductions could be realised by providing cost-effective crisis planning services .
-METHODS	Economic evaluation within a multi-centre randomised controlled trial comparing Joint Crisis Plans ( JCP ) plus treatment as usual ( TAU ) to TAU alone for patients aged over 16 , with at least one psychiatric hospital admission in the previous two years and on the Enhanced Care Programme Approach register .
-METHODS	JCPs , containing the patient 's treatment preferences for any future psychiatric emergency , are a form of crisis intervention that aim to mitigate the negative consequences of relapse , including hospital admission and use of coercion .
-METHODS	Data were collected at baseline and 18-months after randomisation .
-METHODS	The primary outcome was admission to hospital under the Mental Health Act .
-METHODS	The economic evaluation took a service perspective ( health , social care and criminal justice services ) and a societal perspective ( additionally including criminal activity and productivity losses ) .
-RESULTS	The addition of JCPs to TAU had no significant effect on compulsory admissions or total societal cost per participant over 18-months follow-up .
-RESULTS	From the service cost perspective , however , evidence suggests a higher probability ( 80 % ) of JCPs being the more cost-effective option .
-RESULTS	Exploration by ethnic group highlights distinct patterns of costs and effects .
-RESULTS	Whilst the evidence does not support the cost-effectiveness of JCPs for White or Asian ethnic groups , there is at least a 90 % probability of the JCP intervention being the more cost-effective option in the Black ethnic group .
-CONCLUSIONS	The results by ethnic group are sufficiently striking to warrant further investigation into the potential for patient gain from JCPs among black patient groups .
-BACKGROUND	Current Controlled Trials ISRCTN11501328 .
-
-###25623680
-OBJECTIVE	To determine whether the additional benefits of improved prostate cancer detection associated with 5-reductase inhibitors are sufficient to warrant chemoprevention in the case where the degree of prostate cancer risk reduction is deemed inadequate .
-METHODS	We reanalyzed data from REDUCE , a randomized trial of dutasteride for prostate cancer chemoprevention in men with prior negative biopsy .
-METHODS	We evaluated whether statistical models using prostate-specific antigen ( PSA ) and PSA velocity could help predict the result of repeat prostate biopsy separately for dutasteride and placebo groups .
-METHODS	Area under the curve was evaluated by 10-fold cross-validation .
-RESULTS	PSA velocity improved discrimination at 4 years in the dutasteride group but not at 2 years nor in the placebo group .
-RESULTS	At 2 years , dutasteride improved discrimination of PSA slightly ( 0.616 vs. 0.603 for any grade cancer ; 0.681 vs. 0.676 for high-grade disease ) .
-RESULTS	Between-group differences in cancer rates at 4 years were small .
-CONCLUSIONS	Clinicians who are willing to treat at least 23 patients with dutasteride for 2 years to avoid 1 prostate cancer diagnosis should offer dutasteride after initial negative biopsy .
-CONCLUSIONS	Clinicians not willing to do so might consider dutasteride for its additional benefit of reducing unnecessary biopsy , although this benefit is apparent only under very restrictive conditions .
-CONCLUSIONS	It is difficult to justify extending treatment with dutasteride for > 2 years .
-
-###26075373
-OBJECTIVE	The aim of this study was to compare the vacuum assisted wound closure ( VAC ) system ( negative pressure wound therapy ; NPWT ) and alginate wound dressings in terms of quality of life ( QoL ) , pain resource use and cost in patients with deep peri-vascular groin infection after vascular surgery .
-METHODS	Patients with deep peri-vascular groin infection ( Szilagyi grade III ) were included and randomised to NPWT or alginate therapy .
-METHODS	EuroQol 5D ( EQ-5D ) and brief pain inventory ( BPI ) were used to evaluate QoL and pain , respectively .
-RESULTS	Wound healing time until complete skin epithelialisation was shorter in the NPWT ( n = 9 ) compared to the alginate group ( n = 7 ) , median 57 and 104 days , respectively ( p = 0.026 ) .
-RESULTS	No difference was recorded in QoL and pain between the groups at study start and the second assessment .
-RESULTS	QoL analysis within groups between time points , showed that patients in NPWT groups improved in EQ-5D domains , ` self-care ' ( p = 0.034 ) , ` usual activities ' ( p = 0.046 ) ; EQ-5D index value ( p = 0.046 ) and EQ-VAS ( p = 0.028 ) .
-RESULTS	Patients in the NPWT group reported significantly less pain ` affecting their relations with other people ' and ` sleep ' between time points .
-RESULTS	The NPWT group had significantly fewer dressing changes compared to the alginate group ( p < 0.001 ) .
-RESULTS	The median frequency of wound dressing changes outside hospital was 20 ( IQR 6-29 ) in the NPWT group ( n = 9 ) , compared to 48 ( IQR 42-77 ) in the alginate group ( n = 8 ; p = 0.004 ) .
-RESULTS	The saved personnel time for wound care in the first week for the NPWT group , compared with the alginate group , was 4.5 hours per week per nurse .
-RESULTS	The total hospitalised care cost was 83-87 % of the total cost in both groups .
-CONCLUSIONS	NPWT therapy in patients with deep peri-vascular groin infection can be regarded as the dominant strategy due to improved clinical outcome with equal cost and quality of life measures .
-
-###24934402
-BACKGROUND	Allergen-specific immunotherapy ( SIT ) faces problems related to side effects and limited efficacy .
-BACKGROUND	Direct administration of allergen extracts into lymph nodes induces increased specific IgG production and T-cell responses using significantly lower allergen doses .
-METHODS	In this study , mechanisms of immune regulation by MAT vaccines in vitro and in allergen-SIT of cat-allergic rhinitis patients , who received 3 inguinal intra-lymph node injections of MAT-Fel d 1 vaccine , were investigated in PBMC and cell cultures for specific T-cell proliferation , Fel d 1-tetramer-specific responses , and multiple immune regulatory molecules .
-RESULTS	MAT-Fel d 1 vaccine was efficiently internalized by antigen-presenting cells .
-RESULTS	This was followed by precaspase 1 cleavage to caspase 1 and secretion of IL-1 , indicating inflammasome activation .
-RESULTS	Mat-Fel d 1 induced specific T-cell proliferation and an IL-10 - and IFN -- dominated T-cell responses with decreased Th2 cytokines at 100 times lower doses than Fel d 1 .
-RESULTS	Induction of immune tolerance by MAT-Fel d 1-ILIT involved multiple mechanisms of immune suppression .
-RESULTS	Early Fel d 1-specific T-cell activation was followed by full T-cell unresponsiveness to allergen after 1year in the MAT-Fel d 1 group , characterized by increased allergen-specific T regulatory cells , decreased circulating Fel d 1 tetramer-positive cells , increased IL-10 and FOXP3 expression , and change in the HR2/HR1 ratio toward HR2 .
-CONCLUSIONS	This study demonstrates the induction of allergen tolerance after 3 intra-lymph node injections of MAT-Fel d 1 vaccine , mediated by increased cellular internalization of the allergen , activation of inflammasome , and generation of allergen-specific peripheral T-cell tolerance .
-
-###24617231
-OBJECTIVE	To compare the difference in the efficacy on thoracic facet joint disorder between the combined therapy of electroacupuncture and manual reduction and the simple manual reduction .
-METHODS	One hundred and sixty patients were randomized into an electroacupuncture and manual manipulation group ( group A ) and a simple manual manipulation group ( group B ) , 80 cases in each one .
-METHODS	In the group A , Ashi points and three pairs of Jiaji ( EX-B 2 ) bilateral to the painful sites were selected .
-METHODS	The perpendicular puncture was used at Ashi points , the oblique puncture was used at Jiaji ( EX-B 2 ) and connected with electric stimulation for 20 min , additionally , the corresponding manual reduction was adopted at the sites of facet joint disorder .
-METHODS	In the group B , the simple manual reduction was applied to the affected sites .
-METHODS	Acupuncture was given once every day , the manual reduction was applied once every 10 days .
-METHODS	The treatment of 10 days made one session .
-METHODS	The efficacy was analyzed statistically at the end of two sessions of treatment .
-METHODS	Before and after treatment , McGill pain scale was adopted for the value statistical analysis .
-METHODS	PRI score , VAS score and PPI score of patients were calculated before and after treatment and compared in the two groups .
-METHODS	The efficacy was compared between the two groups .
-RESULTS	The curative rate was 56.3 % ( 45/80 ) in the group A , which was better than 18.8 % ( 15/80 ) in the group B ( P < 0.01 ) .
-RESULTS	The total effective rate was 95.0 % ( 76/80 ) in the group A , which was better than 76.3 % ( 61/80 ) in the group B ( P < 0.01 ) .
-RESULTS	The scores of PRI , VAS and PPI after treatment were all improved significantly in the two groups ( all P < 0.05 ) , in which , the results in the group A were better than those in the group B ( PRI : 4.00 + / - 0.97 vs 5.44 + / - 1.16 , VAS : 3.29 + / - 0.72 vs 3.87 + / - 0.81 , PPI : 1.07 + / - 0.74 vs 1.64 + / - 0.90 , all P < 0.05 ) .
-CONCLUSIONS	The combined therapy of electroacupuncture and manual manipulation achieves the superior efficacy on thoracic facet joint disorder as compared with the simple manual manipulation .
-CONCLUSIONS	The combined therapy relieves the symptoms of thoracic facet joint disorder and reduces the severity of disorder .
-
-###25370913
-BACKGROUND	Rye bread benefits glucose metabolism .
-BACKGROUND	It is unknown whether the same effect is achieved by rye bran-enriched wheat bread .
-BACKGROUND	We tested whether white wheat bread enriched with bioprocessed rye bran ( BRB+WW ) and sourdough wholegrain rye bread ( WGR ) have similar effects on glucose metabolism and plasma level of short chain fatty acids ( SCFAs ) .
-METHODS	Twenty-one ( 12 women ) of 23 recruited subjects completed an intervention with a four-week run-in and two four-week test periods in cross-over design .
-METHODS	White wheat bread ( WW ; 3 % fibre ) was consumed during the run-in , and WGR and BRB+WW ( 10 % fibre ) during the test periods .
-METHODS	A meal test providing 51/33/11 E % from carbohydrates/fat/protein was conducted at the end of each period .
-METHODS	Fasting and postprandial plasma samples were analysed for glucose , insulin , and SCFA .
-RESULTS	Glucose and insulin responses and plasma concentrations of SCFAs to the meal test were similar between the WGR and BRB+WW periods .
-RESULTS	When compared to the WW period , postprandial insulin concentration at 120 min was lower ( p = 0.023 ) and the first-phase insulin secretion improved ( p = 0.033 ) only after the WGR period , whereas postprandial concentrations of butyrate ( p < 0.05 ) and propionate ( p = 0.009 ) at 30 min increased during both rye bread periods .
-CONCLUSIONS	Beneficial effects of WGR over white wheat bread on glucose and SCFA production were confirmed .
-CONCLUSIONS	The enrichment of the white wheat bread with bioprocessed rye bran ( BRB+WW ) yielded similar but not as pronounced effects than WGR when compared to WW alone .
-CONCLUSIONS	Postprandially measured glucose metabolism and concentrations of SCFAs provided additional information along with fasting measurements .
-
-###26001837
-BACKGROUND	Evidence suggests that cardiac output-guided haemodynamic therapy algorithms improve outcomes after high-risk surgery , but there is some concern that this could promote acute myocardial injury .
-BACKGROUND	We evaluated the incidence of myocardial injury in a perioperative goal-directed therapy trial .
-METHODS	Patients undergoing major gastrointestinal surgery ( n = 723 ) were randomly assigned to cardiac output-guided haemodynamic therapy ( intervention group ) or usual care as part of the OPTIMISE trial .
-METHODS	At four participating sites , 288 patients were enrolled in a biomarker substudy .
-METHODS	Serum high-sensitivity cardiac troponin I ( TnI ) concentration and N-terminal pro-brain natriuretic peptide ( NT-proBNP ) concentration were measured before and at 24 and 72 h after surgery .
-RESULTS	Median preoperative TnI and NT-ProBNP concentrations were 4.3 ng litre ( -1 ) and 144 pg ml ( -1 ) , respectively .
-RESULTS	After surgery , 67 ( 46 % ) patients in the intervention group and 68 ( 48 % ) patients receiving usual care had TnI concentrations above the 99th centile upper reference limit ( P = 0.82 ) .
-RESULTS	Peak serum TnI concentration was similar in the intervention and usual care groups ( median [ interquartile range ] : 10.0 [ 5.3-21 .5 ] vs 7.8 [ 5.0-21 .8 ] ng litre ( -1 ) ; P = 0.85 ) , and no differences were observed in serum TnI concentrations over 72 h ( repeated-measures anova , P = 0.51 ) .
-RESULTS	Likewise , there were no differences in peak NT-proBNP concentration between intervention and usual care groups ( 645 [ 362-1169 ] vs 659 [ 381-1028 ] pg ml ( -1 ) ; P = 0.86 ) or in serial NT-proBNP concentrations over 72 h ( P = 0.20 ) .
-CONCLUSIONS	Myocardial injury is common among patients undergoing major gastrointestinal surgery .
-CONCLUSIONS	In this study , the frequency was not affected by cardiac output-guided fluid and low-dose inotropic therapy .
-
-###24839144
-OBJECTIVE	Lactoferrin ( LF ) is effective in the prevention of sepsis in very low birth weight ( VLBW ) neonates .
-OBJECTIVE	T-regulatory cells ( Tregs ) are important subsets of T lymphocytes that control pathogen-specific immune responses and are essential for intestinal immune homoeostasis .
-OBJECTIVE	The aim of the present study is to determine whether oral LF at a dosage of 200 mg/d reduces nosocomial sepsis episodes and necrotizing enterocolitis ( NEC ) in premature infants and to evaluate the possible effects of LF on Treg levels .
-METHODS	In this prospective , placebo-controlled , double-blind , randomized trial , infants either VLBW or born before 32 weeks were assigned to receive either placebo ( n = 25 ) , or 200 mg LF ( n = 25 ) daily throughout hospitalization .
-METHODS	Episodes of culture proven nosocomial sepsis and NEC were recorded .
-METHODS	The level of FOXP3 + CD4 + CD25hi lymphocytes was studied by flow cytometry at birth and discharge .
-METHODS	A third comparison was made with healthy term neonates ( n = 16 ) .
-RESULTS	Fewer sepsis episodes were observed in LF-treated infants ( 4.4 vs. 17.3 / 1,000 patient days , p = 0.007 ) with none developing NEC , without statistical significance .
-RESULTS	Treg levels at birth and discharge were similar , while preterm infants showed significantly lower levels than term controls .
-RESULTS	However , individual increases in Treg levels were higher in the LF group .
-CONCLUSIONS	LF prophylaxis reduced nosocomial sepsis episodes .
-CONCLUSIONS	Treg levels in preterm infants were lower than in term infants and an increase of Treg levels under LF prophylaxis was observed .
-CONCLUSIONS	Increase in Treg levels can be the mechanism for protective effects of LF on nosocomial sepsis .
-
-###24867069
-OBJECTIVE	Among people with diabetes , 10-25 % will experience a foot ulcer .
-OBJECTIVE	Research has shown that supplementation with arginine , glutamine and - hydroxy -- methylbutyrate may improve wound repair .
-OBJECTIVE	This study tested whether such supplementation would improve healing of foot ulcers in persons with diabetes .
-METHODS	Along with standard of care , 270 subjects received , in a double-blinded fashion , ( twice per day ) either arginine , glutamine and - hydroxy -- methylbutyrate or a control drink for 16 weeks .
-METHODS	The proportion of subjects with total wound closure and time to complete healing was assessed .
-METHODS	In a post-hoc analysis , the interaction of serum albumin or limb perfusion , as measured by ankle-brachial index , and supplementation on healing was investigated .
-RESULTS	Overall , there were no group differences in wound closure or time to wound healing at week 16 .
-RESULTS	However , in subjects with an albumin level of 40 g/l and/or an ankle-brachial index of < 1.0 , a significantly greater proportion of subjects in the arginine , glutamine and - hydroxy -- methylbutyrate group healed at week 16 compared with control subjects ( P = 0.03 and 0.008 , respectively ) .
-RESULTS	Those with low albumin or decreased limb perfusion in the supplementation group were 1.70 ( 95 % CI 1.04-2 .79 ) and 1.66 ( 95 % CI 1.15-2 .38 ) times more likely to heal .
-CONCLUSIONS	While no differences in healing were identified with supplementation in non-ischaemic patients or those with normal albumin , addition of arginine , glutamine and - hydroxy -- methylbutyrate as an adjunct to standard of care may improve healing of diabetic foot ulcers in patients with risk of poor limb perfusion and/or low albumin levels .
-CONCLUSIONS	Further investigation involving arginine , glutamine and - hydroxy -- methylbutyrate in these high-risk subgroups might prove clinically valuable .
-
-###25286684
-OBJECTIVE	To study the clinical effects of `` Reinforcing Qi and Activating Blood '' in the treatment of stable chronic obstructive pulmonary disease ( Qi Deficiency and Blood Stasis Syndrome ) .
-METHODS	This study recruit 50 outpatients with stabe chronic obstructive pulmonary disease ( Qi Deficiency and Blood Stasis Syndrome ) , who were randomly divided into 2 groups , control group and treatment of `` Reinforcing Qi and Activating Blood '' group .
-METHODS	The patients in control group were given conventional treatment , while the patients in treatment group not only received conventional treatment but also the treatment of Yu-Ping-Feng capsules and Fu-Fang-Dan-Shen tablets for 3 months .
-METHODS	The duration of follow up was 12 months , and chinese medicine ( CM ) symptoms , cellular immunity indexes and haemodynamics indexes were assessed every 3 months .
-RESULTS	The total effective rate in treatment group at 3 months treatment and 3 months follow-up were higher than that in control group ( P < 0.05 ) .
-RESULTS	The CM symptoms in treatment group were improved significantly ( P < 0.05 ) .
-RESULTS	In treatment group , the level of CD4 and the ratio of CD4/CD8 after therapy were higher than those before ( P < 0.05 ) , and the level of CD8 was lower than that before ( P < 0.05 ) .
-RESULTS	The level of NO was no significant difference ( P > 0.05 ) , while the level of endothelin ( ET ) was significantly different ( P < 0.05 ) .
-RESULTS	The frequency of suffering from cold , the admission due to acute exacerbation and hospital stay in treatment group were all lower than those in control group ( P < 0.05 ) .
-CONCLUSIONS	The `` Reinforcing Qi and Activating Blood '' therapy can improve the symptoms and clinical curative effect of TCM in the treatment of stable COPD ( Qi Deficiency and Blood Stasis Syndrome ) , with the improvement of their cellular immunological function and vasomotor function .
-
-###25015006
-OBJECTIVE	Clonidine is often used as a sedative in critically ill children , but its effectiveness has not been evaluated in a large , rigorous randomized controlled trial .
-OBJECTIVE	Our objectives in this pilot trial were to assess the feasibility of a larger trial with respect to ( 1 ) effective screening , ( 2 ) recruitment , ( 3 ) timely drug administration , and ( 4 ) protocol adherence .
-METHODS	This is a randomized , blinded , placebo-controlled pilot trial .
-METHODS	Mechanically ventilated children received enteral clonidine 5 g/kg or placebo every 6 hours ; additional sedatives were at the discretion of attending physicians .
-RESULTS	We enrolled 50 children .
-RESULTS	The median interquartile range ( IQR ) age was 2.5 ( 0.7-5 .2 ) years , and Pediatric Risk of Mortality score on pediatric intensive care unit admission was 12 ( 8-15 ) .
-RESULTS	In terms of feasibility outcomes , 90 ( 87 % ) of 104 eligible patients were approached for consent , and on average , 1.7 children were enrolled per month .
-RESULTS	Thirty-five ( 70 % ) were enrolled within 1 day of becoming eligible ( mean , 1.2 days ) .
-RESULTS	Thereafter , 94 % of doses were administered by protocol .
-RESULTS	Clinical outcomes and adverse effects were not significantly different between the groups .
-CONCLUSIONS	This pilot trial demonstrated feasibility of a larger randomized controlled trial .
-CONCLUSIONS	Some important challenges emerged , allowing refinement of the study protocol and enrolment estimates .
-CONCLUSIONS	We recommend that future trials capitalize on the experience gained and use these results to design a larger trial focusing on clinically important outcomes .
-
-###24777901
-OBJECTIVE	To evaluate the impact of ` Resident Antimicrobial Management Plan ' ( RAMP ) , a novel antimicrobial stewardship tool on systemic antibiotic use for treatment of infection in nursing homes ( NHs ) .
-METHODS	A pilot cluster randomized control study was conducted in 30 NHs in London .
-METHODS	Pre-intervention , we collected point prevalence data on antimicrobial use on three occasions and total antimicrobial consumption for a 12 week period .
-METHODS	Post-intervention data were collected in the same manner and included assessment of compliance with RAMP in the intervention group ( IG ) .
-RESULTS	The number of residents included was 1628 pre-intervention [ 825 IG/803 control group ( CG ) ] and 1610 post-intervention ( 838 IG/772 CG ) .
-RESULTS	The corresponding pre - and post-intervention point prevalence of systemic antibiotic prescribing for treatment of infection was 6.46 % and 6.52 % in the IG [ estimated prevalence ratio : 1.01 ( 95 % CI : 0.81-1 .25 ) , P = 0.94 ] compared with 5.27 % and 5.83 % , respectively , in the CG [ estimated prevalence ratio : 1.11 ( 95 % CI : 0.87-1 .41 ) , P = 0.4 ] .
-RESULTS	Total antibiotic consumption was 69.78 defined daily doses/1000 residents/day ( DRD ) pre-intervention and 66.53 DRD post-intervention in the IG compared with 49.68 and 51.92 DRD , respectively , in the CG .
-RESULTS	There was a significant decrease of 4.9 % ( 3.25 DRD ) in the IG ( 95 % CI : 1.0 % -8.6 % ) ( P = 0.02 ) compared with a significant increase of 5.1 % ( 2.24 DRD ) in the CG ( 95 % CI : 0.2 % -10.2 % ) ( P = 0.04 ) .
-RESULTS	Main indications for antibiotics were lower respiratory tract infections ( 34.1 % ) , urinary tract infections ( 28.5 % ) and skin/soft tissue infections ( 25.1 % ) .
-CONCLUSIONS	This pilot study demonstrated that use of RAMP was associated with a statistically significant decrease in total antibiotic consumption and has the potential to be an important antimicrobial stewardship tool for NHs .
-
-###24386744
-BACKGROUND	Cleft lip and cleft palate are the most common craniofacial anomalies affecting approximately 2.49 of every 1,000 children born in North-east of Thailand .
-BACKGROUND	Srinagarind Hospital has 100-150 cases of cleft lip each year .
-BACKGROUND	Children with cleft lip and palate need surgical procedures as soon as possible .
-BACKGROUND	After lip repair the normal recommendation is not using bottle or breast feeding for 2 weeks to avoid tension at the sutured area during sucking and possible cause of wound dehiscence .
-BACKGROUND	So this is quite complicated for the parents , and patients feel frustrated , cry , and move their head around , because of hunger which can not easily be satisfied .
-BACKGROUND	Previous research found that sucking does not cause wound dehiscence , but mentioned no detail about severity of cleft .
-OBJECTIVE	Primary objective is to compare surgical wound dehiscence between breast feeding/bottle and spoon/syringe feeding after lip repair .
-METHODS	This is an experimental study : non-inferiority trials study .
-METHODS	The population is the patients with cleft lip who underwent lip repair in Inpatient Department 3C , Srinagarind Hospital , Faculty of Medicine , Khon Kaen University .
-METHODS	The study period is during May 2010-February 2013 .
-METHODS	The total sample size in the present study is 192 participants , 96 cases breast/bottle feeding , 96 cases spoon/syringe feeding .
-METHODS	The wound dehiscence rate was analyzed by Z-test .
-METHODS	Parents ` satisfaction is a qualitative data and was analyzed through content analysis .
-RESULTS	No statistical significant diference between breast/bottle and spoon/syringe groups ( p-value = 0.320 , 95 % confidence interval -0.031 -0.010 ) .
-RESULTS	Parents were more satisfied to feed children by breast/bottle and patients were more relaxed with breast/bottle feeding .
-CONCLUSIONS	Breast/bottle feeding and syringe/spoon feeding have the same result on the surgical wound .
-CONCLUSIONS	Breast/bottle feeding are not causes of wound dehiscence .
-
-###25444576
-BACKGROUND	The benefit of protein supplementation on the adaptive response of muscle to exercise training in older people is controversial .
-OBJECTIVE	To investigate the independent and combined effects of a multicomponent exercise program with and without a milk-based nutritional supplement on muscle strength and mass , lower-extremity fatigue , and metabolic markers .
-METHODS	A sample of 48 healthy sedentary men aged 60.8 0.4 years were randomly assigned to a 16-week multicomponent exercise training program with a milk-based supplement containing , besides proteins [ total milk proteins 4 or 10 g/day or soluble milk proteins rich in leucine ( PRO ) 10 g/day ] , carbohydrates and fat .
-METHODS	Body composition , muscle mass and strength , and time to task failure , an index of muscle fatigue , were measured .
-METHODS	Blood lipid , fibrinogen , creatine phosphokinase , glucose , insulin , C-reactive protein , interleukin-6 , tumor necrosis factor - soluble receptors , and endothelial markers were assessed .
-RESULTS	Body fat mass was reduced after the 4-month training program in groups receiving 10 g/day of protein supplementation ( P < .01 ) .
-RESULTS	The training program sustained with the daily 10 g/day PRO was associated with a significant increase in dominant fat free mass ( +5.4 % , P < .01 ) and in appendicular muscle mass ( +4.5 % , P < .01 ) .
-RESULTS	Blood cholesterol was decreased in the trained group receiving 10 g/day PRO .
-RESULTS	The index of insulin resistance ( homeostasis model assessment-insulin resistance ) and blood creatine phosphokinase were reduced in the groups receiving 10 g/day PRO , irrespective of exercise .
-RESULTS	The inflammatory and endothelial markers were not different between the groups .
-RESULTS	Training caused a significant improvement ( +10.6 % to 19.4 % , P < .01 ) in the maximal oxygen uptake .
-RESULTS	Increased maximum voluntary contraction force was seen in the trained groups receiving 10 g/day of proteins ( about 3 % , P < .05 ) .
-RESULTS	Time to task failure was improved in the trained participants receiving a 10 g/day supplementation with PRO ( P < .01 ) .
-CONCLUSIONS	Soluble milk proteins rich in leucine improved time to muscle failure and increase in skeletal muscle mass and strength after prolonged multicomponent exercise training in healthy older men .
-
-###24997826
-OBJECTIVE	To compare the effects of piglitazone and metformin on retinol-binding protein-4 ( RBP-4 ) and adiponcetin ( APN ) in patients with type 2 diabetes mellitus ( T2DM ) complicated with Non alcohol fatty acid liver disease ( NAFLD ) .
-METHODS	Totally 60 T2DM patients complicated with NAFLD were equally and randomly divided into pioglitazone group and metform group .
-METHODS	The levels of biochemical indicators including body mass index ( BMI ) , glucose hemoglobin A1C ( GHbA1C ) , insulin resistance ( HOMA-IR ) , fasting blood glucose ( FBG ) , fasting insulin ( FIns ) , and serum triglycerides ( TG ) as well as serum RBP-4 and APN level were measured pre-treatment and 12 weeks after treatments .
-RESULTS	After 12 weeks of treaments , BMI , FBG , HOMA-IR , GHbA1C , FIns , and TG decreased ( all P < 0.05 ) in both piglitazone group and metform group .
-RESULTS	APN increased ( all P < 0.05 ) in both groups .
-RESULTS	RBP-4 decreased ( P < 0.05 ) in piglitazone group .
-RESULTS	Compare with the metform group , the levels of RBP-4 , FIns , and HOMA-IR decreased and BMI increased in piglitazone group ( P < 0.05 ) .
-CONCLUSIONS	Piglitazone is superior to metoform in decreasing RBP-4 level and HOMA-IR in patients with T2DM complicated with NAFLD .
-
-###25601538
-BACKGROUND	Angiotensin-converting enzyme inhibitor-induced angioedema ( ACEI-AE ) is mediated by bradykinin .
-BACKGROUND	There remains an unmet treatment need because these patients , when presenting to the emergency department ( ED ) , do not respond to conventional therapies , such as antihistamines and corticosteroids .
-OBJECTIVE	To estimate the treatment effect of ecallantide , a recombinant plasma kallikrein inhibitor , in ED patients with ACEI-AE in whom conventional therapy fails .
-METHODS	This was a triple-blind ( patient , physician , and statistician ) , randomized , controlled , phase 2 study to estimate the magnitude of safety and efficacy signals for designing a definitive phase 3 trial comparing conventional therapy with ecallantide to conventional therapy with placebo .
-METHODS	Patients were enrolled from April 1 , 2010 , through January 31 , 2013 .
-METHODS	The primary efficacy study end point was achieving discharge criteria from the ED within 4 hours after initiating study-related treatment .
-RESULTS	Discharge criteria from the ED was met in 4 hours or less for 8 ( 31 % ) of 26 patients receiving ecallantide vs 5 of ( 21 % ) 24 patients receiving placebo ( difference in proportions , 10 % ; 95 % confidence interval,-14 % to 34 % ) .
-RESULTS	Ecallantide was well tolerated in both groups .
-CONCLUSIONS	The results from this preliminary study reveal that ecallantide is safe to use and may increase the proportion of patients who meet early discharge criteria by approximately10 % .
-CONCLUSIONS	A larger phase 3 study is necessary to confirm the efficacy and evaluate the cost-effectiveness of ecallantide use for ACEI-AE in the ED setting .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01036659 .
-
-###24708735
-BACKGROUND	Vitamin A supplementation significantly reduces all-cause mortality when given between 6-59 months of age , but has a null or detrimental effect when given between 1-5 months .
-BACKGROUND	Studies of neonatal vitamin A supplementation conducted across Africa and South Asia have produced conflicting findings .
-BACKGROUND	These age-pattern variations might result from immunological interactions between vitamin A supplementation and vaccines .
-BACKGROUND	Knowledge on the potential immunological sequelae of human neonatal vitamin A supplementation is so scarce that the foremost aim of this study is to seek indicative data on aspects of immunity likely to be affected by neonatal vitamin A supplementation .
-BACKGROUND	The objective of this trial is to test whether human neonatal vitamin A supplementation modulates immune function including improved thymic maturation in infancy and improved systemic immune responses to routine immunization .
-METHODS	In an area of moderate vitamin A deficiency in a peri-urban area of The Gambia , 200 mother-infant pairs were enrolled in a double-blind randomised controlled trial .
-METHODS	Within 48 hours of birth , neonates were randomised with stratification by birth weight and sex to receive either an oral dose of 50,000 IU vitamin A or placebo .
-METHODS	Expanded Programme of Immunisation birth vaccinations were administered after supplementation , with subsequent vaccinations administered at 8 , 12 and 16 weeks of age .
-METHODS	A range of immunological outcomes were examined up to 17 weeks of age , with additional morbidity and anthropometry follow-up carried out throughout the first year of life .
-METHODS	The primary endpoint of this trial is the frequency of circulating T regulatory ( Treg ) cells expressing gut homing receptors in infants at 17 week post-supplementation , with secondary outcomes including thymus maturation and B cell immune responses .
-CONCLUSIONS	Indicative immunological data from this trial ( and its Bangladeshi counterpart ) , will complement the larger randomised controlled trials ( conducted in India , Tanzania and Ghana ) , on the effectiveness and safety of neonatal vitamin A supplementation in improving infant survival .
-CONCLUSIONS	Combined these trials , in addition to the existing trials , will inform policy .
-BACKGROUND	clinicaltrials.gov NCT01476358 .
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-###25361980
-BACKGROUND	Everolimus is an agent frequently associated with specific toxicities .
-BACKGROUND	Predictive markers of efficacy are needed to help define which patients could benefit from it .
-BACKGROUND	The goal of this exploratory study was to identify potential predictive biomarkers in the mammalian target of rapamycin ( mTOR ) complex 1 ( mTORC1 ) activation pathway using primary tumor samples collected during the phase II tamoxifen plus everolimus ( TAMRAD ) trial .
-METHODS	Tumor tissues were collected retrospectively from the TAMRAD trial .
-METHODS	Immunohistochemistry was carried out using specific antibodies directed toward proteins that result in mTORC1 activation [ canonical phosphatidylinositol 3-kinase ( PI3K ) / protein kinase B ( Akt ) / mTOR or alternative pathways ] .
-METHODS	DNA was extracted from the tumor tissue ; mutation screening in the PIK3CA gene ( exons 9 and 20 ) and the KRAS gene ( exons 2 and 3 ) was first carried out using Sanger direct sequencing , and then completed by next-generation sequencing for PIK3CA .
-METHODS	An exploratory analysis of everolimus efficacy in terms of a time-to-progression ( TTP ) increase was carried out in each biomarker subgroup ( high versus low expression referring to the median percentage of marked cells ) .
-RESULTS	A total of 55 primary tumor samples from the TAMRAD trial25 from the tamoxifen-alone group and 30 from the tamoxifen/everolimus groupwere evaluated for biomarkers .
-RESULTS	The subgroups most likely to have an improvement in TTP with tamoxifen/everolimus therapy , compared with tamoxifen alone , were patients with high p4EBP1 , low 4EBP1 , low liver kinase B1 , low pAkt , and low PI3K .
-RESULTS	Among the 45 samples screened for mutation status , nine samples ( 20 % ; 95 % CI 9.6-34 .6 ) had a PIK3CA mutation .
-RESULTS	KRAS mutation was observed in one patient .
-CONCLUSIONS	A positive correlation between late effectors of mTORC1 activation , a positive correlation between Akt-independent mTORC1 activation , and an inverse correlation between canonical PI3K/Akt/mTOR pathway and everolimus efficacy were observed in this exploratory analysis .
-CONCLUSIONS	However , these correlations need to be validated in larger studies before applying the findings to routine clinical practice .
-
-###24841548
-BACKGROUND	Observational studies have documented an off-pump over on-pump advantage for high-risk patients , including diabetic patients .
-BACKGROUND	Randomized trials have not confirmed this advantage .
-BACKGROUND	The VA Randomization On Versus Off Bypass ( ROOBY ) trial randomly assigned 2,203 coronary artery bypass graft surgery ( CABG ) patients at 18 sites to either on-pump ( n = 1,099 ) or off-pump ( n = 1,104 ) procedures .
-BACKGROUND	An a priori ROOBY aim was to evaluate treatment impact on diabetic patients .
-METHODS	Actively treated diabetic patients ( n = 835 , receiving oral hypoglycemic or insulin medications ) received off-pump CABG ( n = 402 ) or on-pump CABG ( n = 433 ) .
-METHODS	The primary ROOBY trial endpoints were a short-term composite ( 30-day operative death or major complications ) and a 1-year composite ( death , nonfatal acute myocardial infarction , or repeat revascularization ) .
-METHODS	Secondary ROOBY endpoints included 1-year all-cause death , 1-year graft patency , 1-year changes from baseline in neurocognitive status and health-related quality of life , and costs .
-RESULTS	Diabetic patients ' risk factors at baseline were balanced across treatments .
-RESULTS	For diabetic patients , the primary short-term composite outcome rate showed a worse trend for off-pump ( 8.0 % ) than on-pump ( 3.9 % , p = 0.013 ) , with no difference in the 1-year primary composite outcome or 1-year death rate .
-RESULTS	One-year patency was 83.1 % off-pump versus 88.4 % on-pump ( p = 0.004 ) .
-RESULTS	No differences were found in neurocognitive , health-related quality of life , discharge cost , and 1-year cumulative cost .
-CONCLUSIONS	Concordant with the ROOBY trial 's overall findings , off-pump CABG yielded no advantage over on-pump CABG for actively treated diabetic patients .
-CONCLUSIONS	The 1-year graft patency was lower and the short-term composite trended higher for off-pump CABG , with no other significant outcome or cost differences .
-
-###24947633
-BACKGROUND	Closure of the hernia gap in laparoscopic ventral hernia repair before mesh reinforcement has gained increasing acceptance among surgeons despite creating a tension-based repair .
-BACKGROUND	Beneficial effects of this technique have been reported sporadically , but no evidence is available from randomised controlled trials .
-BACKGROUND	The primary purpose of this paper is to compare early post-operative activity-related pain in patients undergoing laparoscopic ventral hernia repair with closure of the gap with patients undergoing standard laparoscopic ventral hernia repair ( non-closure of the gap ) .
-BACKGROUND	Secondary outcomes are patient-rated cosmesis and hernia-specific quality of life .
-METHODS	A randomised , controlled , double-blinded study is planned .
-METHODS	Based on power calculation , we will include 40 patients in each arm .
-METHODS	Patients undergoing elective laparoscopic umbilical , epigastric or umbilical trocar-site hernia repair at Hvidovre Hospital and Herlev Hospital , Denmark , are invited to participate .
-CONCLUSIONS	The gap closure technique may induce more post-operative pain than the non-closure repair , but it may also be superior with regard to other important surgical outcomes .
-CONCLUSIONS	No studies have previously investigated closure of the gap in the setting of a randomised controlled trial .
-BACKGROUND	The study is funded by The University of Copenhagen and private foundations .
-BACKGROUND	NCT01962480 ( clinicaltrials.gov ) .
-
-###25280578
-BACKGROUND	Most people referred to rapid access chest pain clinics have non-cardiac chest pain , and in those diagnosed with stable coronary heart disease , guidance recommends that first-line treatment is usually medication rather than revascularisation .
-BACKGROUND	Consequently , many patients are not reassured they have the correct diagnosis or treatment .
-BACKGROUND	A previous trial reported that , in people with non-cardiac chest pain , a brief discussion with a health psychologist before the tests about the meaning of potential results led to people being significantly more reassured .
-BACKGROUND	The aim of this pilot was to test study procedures and inform sample size for a future multi-centre trial and to gain initial estimates of effectiveness of the discussion intervention .
-METHODS	This was a two-arm pilot randomised controlled trial in outpatient rapid access chest pain clinic in 120 people undergoing investigation for new onset , non-urgent chest pain .
-METHODS	Eligible participants were randomised to receive either : a discussion about the meaning and implication of test results , delivered by a nurse before tests in clinic , plus a pre-test pamphlet covering the same information ( Discussion arm ) or the pre-test pamphlet alone ( Pamphlet arm ) .
-METHODS	Main outcome measures were recruitment rate and feasibility for a future multi-centre trial , with an estimate of reassurance in the groups at month 1 and 6 using a 5-item patient-reported scale .
-RESULTS	Two hundred and seventy people attended rapid access chest pain clinic during recruitment and 120/270 participants ( 44 % ) were randomised , 60 to each arm .
-RESULTS	There was no evidence of a difference between the Discussion and Pamphlet arms in the mean reassurance score at month 1 ( 34.2 vs 33.7 ) or at month 6 ( 35.3 vs 35.9 ) .
-RESULTS	Patient-reported chest pain and use of heart medications were also similar between the two arms .
-CONCLUSIONS	A larger trial of the discussion intervention in the UK would not be warranted .
-CONCLUSIONS	Patients reported high levels of reassurance which were similar in patients receiving the discussion with a nurse and in those receiving a pamphlet alone .
-BACKGROUND	Current Controlled Trials ISRCTN60618114 ( assigned 27.05.2011 ) .
-
-###25010300
-OBJECTIVE	To compare the outcomes of bipolar transurethral vaporization of the prostate ( TUVP ) with bipolar transurethral resection of the prostate ( TURP ) .
-METHODS	In a prospective randomized trial , 88 patients with moderate to severe lower urinary tract symptoms secondary to benign prostatic hyperplasia ( BPH ) underwent bipolar TUVP ( N = 39 ) or bipolar TURP ( N = 49 ) from October 2010 to November 2011 .
-METHODS	The inclusion criteria were age > 50 years , prostate volume of 30-80 mL , serum PSA < 4 ng/mL , IPSS 20 , Qmax 10 mL/s and failed medical therapy .
-METHODS	The perioperative and postoperative outcomes were evaluated and the IPSS and Qmax were assessed preoperatively and 3 months after procedure in all cases .
-RESULTS	Both groups were similar in patient age , prostate volume , preoperative IPSS and Qmax .
-RESULTS	The TUVP group had significantly lower mean values of operative time , hospital stay , catheterization period , irrigation fluid volume and serum hemoglobin , creatinine , sodium and potassium changes compared with TURP group .
-RESULTS	No significant differences were seen between two groups regarding complications ( TUVP = 10.3 % ; TURP = 12.2 % ) and modified Clavien classification of complications .
-RESULTS	No TUR syndrome , obturator reflex or epididymitis occurred in both groups .
-RESULTS	Re-hospitalization and transfusion due to clot retention ( N = 2 ) and urethral stricture ( N = 1 ) were reported only in the TURP group .
-RESULTS	Three patients experienced urinary retention after catheter removal in the TUVP group .
-RESULTS	Two patients were re-catheterized temporarily and one patient required repeat bipolar TUVP .
-RESULTS	Three months after surgery , two groups had significant improvement in IPSS and Qmax .
-RESULTS	But the TUVP group had significantly lower IPSS and higher Qmax than TURP group .
-CONCLUSIONS	Bipolar TUVP is a safe , effective and low cost procedure among minimally invasive surgeries of BPH .
-CONCLUSIONS	Compared with bipolar TURP , the bipolar TUVP had similar complications , better perioperative and postoperative outcomes , superior hemostasis and higher efficacy .
-
-###24819981
-OBJECTIVE	Resveratrol , a polyphenol found in grapes , red wine , chocolate , and certain berries and roots , is considered to have antioxidant , anti-inflammatory , and anticancer effects in humans and is related to longevity in some lower organisms .
-OBJECTIVE	To determine whether resveratrol levels achieved with diet are associated with inflammation , cancer , cardiovascular disease , and mortality in humans .
-METHODS	Prospective cohort study , the Invecchiare in Chianti ( InCHIANTI ) Study ( `` Aging in the Chianti Region '' ) , 1998 to 2009 conducted in 2 villages in the Chianti area in a population-based sample of 783 community-dwelling men and women 65 years or older .
-METHODS	Twenty-four-hour urinary resveratrol metabolites .
-METHODS	Primary outcome measure was all-cause mortality .
-METHODS	Secondary outcomes were markers of inflammation ( serum C-reactive protein [ CRP ] , interleukin [ IL ] -6 , IL-1 , and tumor necrosis factor [ TNF ] ) and prevalent and incident cancer and cardiovascular disease .
-RESULTS	Mean ( 95 % CI ) log total urinary resveratrol metabolite concentrations were 7.08 ( 6.69-7 .48 ) nmol/g of creatinine .
-RESULTS	During 9 years of follow-up , 268 ( 34.3 % ) of the participants died .
-RESULTS	From the lowest to the highest quartile of baseline total urinary resveratrol metabolites , the proportion of participants who died from all causes was 34.4 % , 31.6 % , 33.5 % , and 37.4 % , respectively ( P = .67 ) .
-RESULTS	Participants in the lowest quartile had a hazards ratio for mortality of 0.80 ( 95 % CI , 0.54-1 .17 ) compared with those in the highest quartile of total urinary resveratrol in a multivariable Cox proportional hazards model that adjusted for potential confounders .
-RESULTS	Resveratrol levels were not significantly associated with serum CRP , IL-6 , IL-1 , TNF , prevalent or incident cardiovascular disease , or cancer .
-CONCLUSIONS	In older community-dwelling adults , total urinary resveratrol metabolite concentration was not associated with inflammatory markers , cardiovascular disease , or cancer or predictive of all-cause mortality .
-CONCLUSIONS	Resveratrol levels achieved with a Western diet did not have a substantial influence on health status and mortality risk of the population in this study .
-
-###25624196
-OBJECTIVE	To compare antimllerian hormone ( AMH ) and antral follicle count ( AFC ) as predictors of ovarian response to controlled ovarian stimulation at individual fertility clinics .
-METHODS	Retrospective analysis of individual study center data in two multicenter trials .
-METHODS	Centers that provided > 10 patients were included in the analysis .
-METHODS	A total of 19 ( n = 519 patients ) and 18 study centers ( n = 686 patients ) participating in a long GnRH agonist trial ( MERIT ) and a GnRH antagonist trial ( MEGASET ) , respectively .
-METHODS	Infertile women of good prognosis .
-METHODS	Long GnRH agonist or GnRH antagonist cycles .
-METHODS	Correlation between AMH and AFC , and oocyte yield by each study center for each trial .
-RESULTS	Antimllerian hormone was more strongly correlated with oocyte yield than AFC : r = 0.56 vs. r = 0.28 in the GnRH agonist cohort , and r = 0.55 vs. r = 0.33 in the GnRH antagonist cohort .
-RESULTS	The correlation was numerically higher for AMH than for AFC at a significantly higher proportion of study centers : 17 ( 89 % ) and 15 ( 83 % ) centers in the long GnRH agonist and GnRH antagonist trial , respectively .
-RESULTS	Assessment of the relative capacity of AMH and AFC for predicting oocyte yield demonstrated that AMH dominated the model : AMH , R ( 2 ) = 0.29 and 0.23 ; AFC : R ( 2 ) = 0.07 and 0.07 ; AMH + AFC : R ( 2 ) = 0.30 and 0.23 for long GnRH agonist and GnRH antagonist trials , respectively .
-CONCLUSIONS	Antimllerian hormone was a stronger predictor of ovarian response to gonadotropin therapy than AFC at the study center level in both randomized trials utilizing GnRH agonist and GnRH antagonist protocols .
-CONCLUSIONS	Antral follicle count provided no added predictive value beyond AMH .
-
-###24576395
-BACKGROUND	Hispanics are at increased risk of developing type 2 diabetes .
-BACKGROUND	Lifestyle interventions are effective in preventing diabetes and restoring glucose regulation .
-METHODS	We recruited Hispanic men and women ( N = 320 ) who were residents of the Lower Yakima Valley , Washington , aged 18 years or older with hemoglobin A1c ( HbA1c ) levels higher than 6 % to a parallel 2-arm randomized-controlled trial conducted from 2008 through 2012 .
-METHODS	The trial compared participants in the intervention arm , who received an immediate educational curriculum ( n = 166 ) , to participants in the control arm , who received a delayed educational curriculum ( n = 154 ) .
-METHODS	The home-based curriculum consisted of 5 sessions led by community health workers and was designed to inform participants about diabetes , diabetes treatment , and healthy dietary and physical activity behaviors .
-METHODS	Participants were randomly assigned to the intervention and control arms , and analysts were blinded as to participant arm .
-METHODS	We evaluated intervention effects on HbA1c levels ; frequency ( times per week ) of fruit and vegetable consumption ; and frequency ( times per week ) of mild , moderate , and strenuous leisure-time physical activity .
-METHODS	At baseline , 3 months , and 6 months after randomization , participants completed a questionnaire and provided a blood sample .
-METHODS	Analysts were blinded to intervention arm .
-RESULTS	The immediate intervention group ( -0.64 % [ standard error ( SE ) 0.10 ] ) showed a significant improvement in HbA1c scores ( -37.5 % , P = .04 ) compared with the delayed intervention group ( -0.44 % , P = .14 ) .
-RESULTS	No significant changes were seen for dietary end points or changes in physical activity .
-RESULTS	We did observe a trend of greater increases in frequency of moderate and vigorous physical activity and a smaller increase in mild physical activity in the immediate intervention group than in the delayed intervention group .
-CONCLUSIONS	This home-based intervention delivered by CHWs was associated with a clinically and statistically significant reduction in HbA1c levels in Hispanic adults with HbA1c levels higher than 6 % .
-
-###25789518
-OBJECTIVE	To evaluate the impact of a clinical pharmacy program on health outcomes in patients with type 2 diabetes undergoing insulin therapy at a teaching hospital in Brazil .
-METHODS	A randomized controlled trial with a 6-month follow-up period was performed in 70 adults , aged 45 years or older , with type 2 diabetes who were taking insulin and who had an HbA1c level 8 % .
-METHODS	Patients in the control group ( CG ) ( n = 36 ) received standard care , patients in the intervention group ( IG ) ( n = 34 ) received an individualized pharmacotherapeutic care plan and diabetes education .
-METHODS	The primary outcome measure was change in HbA1c .
-METHODS	Secondary outcomes included diabetes and medication knowledge , adherence to medication , insulin injection and home blood glucose monitoring techniques and diabetes-related quality of life .
-METHODS	Outcomes were evaluated at baseline and 6 months using questionnaires .
-RESULTS	Diabetes knowledge , medication knowledge , adherence to medication and correct insulin injection and home blood glucose monitoring techniques significantly improved in the intervention group but remained unchanged in the control group .
-RESULTS	At the end of the study , mean HbA1c values in the control group remained unchanged but were significantly reduced in the intervention group .
-RESULTS	Diabetes-related quality of life significantly improved in the intervention group but worsened significantly in the control group .
-CONCLUSIONS	The program improved health outcomes and resulted in better glycemic control in patients with type 2 diabetes undergoing insulin therapy .
-
-###25055716
-OBJECTIVE	Improving school water , sanitation and hygiene ( WASH ) conditions reduces pupil absence and illness .
-OBJECTIVE	However , these benefits may depend on the conditions of the latrines and availability of consumables .
-OBJECTIVE	We sought to determine whether a low-cost , policy-relevant , environmental-level latrine cleaning intervention could improve latrine cleanliness , increase its use and reduce absenteeism .
-METHODS	In a three-arm , cluster-randomized trial we assessed absence via periodical roll-call among 17 564 pupils in 60 schools that had previously received WASH improvements as part of the SWASH + project .
-METHODS	Latrine conditions and use were also assessed using structured observation .
-METHODS	Latrine cleanliness increased significantly during the post-intervention period among schools receiving the latrine cleaning package compared to controls , as did handwashing with soap .
-METHODS	We found no difference in latrine use and absence across arms .
-CONCLUSIONS	The additive impact of cleaning may not have been strong enough to impact absence above and beyond reductions attributable to the original WASH infrastructure improvements and basic hygiene education the schools previously received .
-CONCLUSIONS	Improving latrine conditions is important for the dignity and well-being of pupils , and investments and strategies are necessary to ensure that school toilets are clean and pupil-friendly .
-
-###24614337
-OBJECTIVE	Several studies have identified relationships between weight loss and adipokine levels ; however , none have looked at the combined effect of aerobic exercise training with the consumption of a low - or a high-glycemic diet .
-OBJECTIVE	We examined the effects of 12 wk of aerobic exercise combined with either a low-glycemic index diet ( 40 U ) plus exercise ( LoGIX ) or a high-glycemic index diet ( 80 U ) diet plus exercise ( HiGIX ) on plasma leptin and adiponectin ( total and high molecular weight [ HMW ] ) in 27 older obese adults ( age = 65 0.5 yr , body mass index = 34.5 0.7 kgm ) .
-METHODS	Insulin sensitivity was calculated from an oral glucose tolerance test .
-METHODS	Fasting HMW adiponectin and leptin were quantified from plasma samples obtained before the insulin sensitivity index obtained from the oral glucose tolerance test .
-METHODS	Glucose and insulin measures were obtained before and every 30 min during the test .
-METHODS	Dual-energy x-ray absorptiometry and computerized tomography were used to determine body composition and to quantify subcutaneous and visceral abdominal adiposity , respectively .
-RESULTS	Fasting leptin was significantly decreased in both groups ( LoGIX : preintervention = 33.8 4.7 , postintervention = 19.2 4.5 ; HiGIX : preintervention = 27.9 4.2 , postintervention = 11.9 2.2 ngmL ; P = 0.004 ) , and HMW adiponectin was significantly increased ( LoGIX : preintervention = 1606.9 34.6 , postintervention = 3502.3 57 ; HiGIX : preintervention = 3704.8 38.1 , postintervention = 4284.3 52.8 pgmL ; P = 0.003 ) after the 12-wk intervention .
-RESULTS	Total body fat was reduced after both interventions .
-RESULTS	Visceral fat mass was inversely correlated with HMW adiponectin , whereas subcutaneous fat correlated with leptin .
-CONCLUSIONS	The data suggest that exercise training , independent of dietary glycemic index , favorably alters HMW adiponectin and leptin secretion and that a reduction in visceral fat mass is a key factor regulating HMW adiponectin in older obese persons .
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-###26148930
-BACKGROUND	Allogeneic mesenchymal precursor cells ( MPCs ) have been effective in large animal models of ischemic and nonischemic heart failure ( HF ) .
-OBJECTIVE	To evaluate the feasibility and safety of 3 doses ( 25 , 75 , or 150 million cells ) of immunoselected allogeneic MPCs in chronic HF patients in a phase 2 trial .
-RESULTS	We sequentially allocated 60 patients to a dosing cohort ( 20 per dose group ) and randomized them to transendocardial MPC injections ( n = 15 ) or mock procedures ( n = 5 ) .
-RESULTS	The primary objective was safety , including antibody testing .
-RESULTS	Secondary efficacy end points included major adverse cardiac events ( MACE ; cardiac death , myocardial infarction , or revascularization ) , left ventricular imaging , and other clinical-event surrogates .
-RESULTS	Safety and MACE were evaluated for up to 3 years .
-RESULTS	MPC injections were feasible and safe .
-RESULTS	Adverse events were similar across groups .
-RESULTS	No clinically symptomatic immune responses were noted .
-RESULTS	MACE was seen in 15 patients : 10 of 45 ( 22 % ) MPC-treated and 5 of 15 ( 33 % ) control patients .
-RESULTS	We found no differences between MPC-treated and control patients in survival probability , MACE-free probability , and all-cause mortality .
-RESULTS	We conducted a post hoc analysis of HF-related MACE ( HF hospitalization , successfully resuscitated cardiac death , or cardiac death ) and events were significantly reduced in the 150 million MPC group ( 0/15 ) versus control ( 5/15 ; 33 % ) , 25 million MPC group ( 3/15 ; 20 % ) , and 75 million MPC group ( 6/15 ; 40 % ) ; the 150 million MPC group differed significantly from all groups according to Kaplan-Meier statistics > 3 years ( P = 0.025 for 150 million MPC group versus control ) .
-CONCLUSIONS	Transendocardial injections of allogeneic MPCs were feasible and safe in chronic HF patients .
-CONCLUSIONS	High-dose allogeneic MPCs may provide benefits in this population .
-
-###25862743
-BACKGROUND	Despite the excess risk of mortality in young women ( 55 years of age ) after acute myocardial infarction ( AMI ) , little is known about young women 's health status ( symptoms , functioning , quality of life ) during the first year of recovery after an AMI .
-BACKGROUND	We examined gender differences in health status over time from baseline to 12 months after AMI .
-RESULTS	A total of 3501 AMI patients ( 67 % women ) 18 to 55 years of age were enrolled from 103 US and 24 Spanish hospitals .
-RESULTS	Data were obtained by medical record abstraction and patient interviews at baseline hospitalization and 1 and 12 months after AMI .
-RESULTS	Health status was measured by generic ( Short Form-12 ) and disease-specific ( Seattle Angina Questionnaire ) measures .
-RESULTS	We compared health status scores at all 3 time points and used longitudinal linear mixed-effects analyses to examine the independent effect of gender , adjusting for time and selected covariates .
-RESULTS	Women had significantly lower health status scores than men at each assessment ( all P values < 0.0001 ) .
-RESULTS	After adjustment for time and all covariates , women had Short Form-12 physical/mental summary scores that were -0.96 ( 95 % confidence interval [ CI ] , -1.59 to -0.32 ) and -2.36 points ( 95 % CI , -2.99 to -1.73 ) lower than those of men , as well as worse Seattle Angina Questionnaire physical limitations ( -2.44 points lower ; 95 % CI , -3.53 to -1.34 ) , more angina ( -1.03 points lower ; 95 % CI , -1.98 to -0.07 ) , and poorer quality of life ( -3.51 points lower ; 95 % CI , -4.80 to -2.22 ) .
-CONCLUSIONS	Although both genders recover similarly after AMI , women have poorer scores than men on all health status measures , a difference that persisted throughout the entire year after discharge .
-
-###24700493
-OBJECTIVE	This pilot study examined the feasibility outcome recruitment , safety and compliance of the investigation for stochastic resonance whole-body vibration ( SR-WBV ) training .
-OBJECTIVE	Another aim was to evaluate the effect size of one SR-WBV intervention session on Short Physical Performance Battery ( SPPB ) , Expanded Timed Get Up-and-Go ( ETGUG ) , isometric maximal voluntary contraction ( IMVC ) and rate of force development ( IRFD ) and chair rising ( CR ) .
-METHODS	Randomised double-blinded controlled cross-over pilot study .
-METHODS	Feasibility outcomes included recruitment , safety and compliance .
-METHODS	For secondary outcomes , SPPB , ETGUG , IMVC , IRFD and CR were measured before and 2-min after intervention .
-METHODS	Nonparametric Rank-Order Tests of Puri and Sen L Statistics to Ranked Data were proposed .
-METHODS	Wilcoxon signed-ranked tests were used to analyse the differences after SR-WBV intervention and sham intervention .
-METHODS	Treatment effects between the interventions were compared by a Mann-Whitney U test .
-RESULTS	Among 24 eligible frail elderly , 12 agreed to participate and 3 drop out .
-RESULTS	The adherence was 15 of 24 intervention sessions .
-RESULTS	For secondary outcome , effect sizes ( ES ) for SR-WBV intervention on SPPB , ETGUG and CR were determined .
-CONCLUSIONS	This pilot study indicate that the training protocol used in this form for frail elderly individuals is feasible but with modification due to the fact that not all defined feasibility outcomes target was met .
-CONCLUSIONS	SR-WBV with 6Hz , noise level 4 shows benefit improvements on SPPB ( ES 0.52 ) , ETGUG ( part sit-to-stand movement : ES 0.81 ; total time : ES 0.85 ) and CR ( ES 0.66 ) .
-CONCLUSIONS	Further research is desired to determine whether a new adapted training protocol is necessary for SR-WBV in the `` skilling up '' phase in frail elderly individuals .
-
-###24614572
-OBJECTIVE	The Effectiveness and Cost of ICD follow-up Schedule with Telecardiology ( ECOST ) trial evaluated prospectively the economic impact of long-term remote monitoring ( RM ) of implantable cardioverter defibrillators ( ICDs ) .
-RESULTS	The analysis included 310 patients randomly assigned to RM ( active group ) vs. ambulatory follow-ups ( control group ) .
-RESULTS	Patients in the active group were seen once a year unless the system reported an event mandating an ambulatory visit , while patients in the control group were seen in the ambulatory department every 6 months .
-RESULTS	The costs of each follow-up strategy were compared , using the actual billing documents issued by the French health insurance system , including costs of ( i ) ( a ) ICD-related ambulatory visits and transportation , ( b ) other ambulatory visits , ( c ) cardiovascular treatments and procedures , and ( ii ) hospitalizations for the management of cardiovascular events .
-RESULTS	The ICD and RM system costs were calculated on the basis of the device remaining longevity at the end of the study .
-RESULTS	The characteristics of the study groups were similar .
-RESULTS	Over a follow-up of 27 months , the mean non-hospital costs per patient-year were 1695 1131 in the active , vs. 1952 1023 in the control group ( P = 0.04 ) , a 257 difference mainly due to device management .
-RESULTS	The hospitalization costs per patient-year were 2829 6382 and 3549 9714 in the active and control groups , respectively ( P = 0.46 ) .
-RESULTS	Adding the ICD to the non-hospital costs , the savings were 494 ( P = 0.005 ) or , when the monitoring system was included , 315 ( P = 0.05 ) per patient-year .
-CONCLUSIONS	From the French health insurance perspective , the remote management of ICD patients is cost saving .
-BACKGROUND	NCT00989417 , www.clinicaltrials.gov .
-
-###25243546
-OBJECTIVE	To test if posterior retroperitoneoscopic adrenalectomy ( PRA ) is superior to lateral transperitoneal laparoscopic adrenalectomy ( LTLA ) .
-BACKGROUND	Most popular LTLA has been recently challenged by an increasing popularity of PRA , which is believed by many surgeons ( not evidence-based ) as superior to LTLA in the treatment of small and benign adrenal tumors .
-METHODS	Participants were assigned randomly to PRA or LTLA and followed for 5 years after surgery .
-METHODS	The primary endpoint was the duration of surgery .
-METHODS	Secondary endpoints were blood loss , conversion rate , postoperative recovery , morbidity , and costs .
-RESULTS	Sixty-five patients were included , of whom 61 ( PRA 30 , LTLA 31 ) completed the 5-year follow-up .
-RESULTS	The following differences were identified in favor of PRA vs LTLA : shorter duration of surgery ( 50.8 vs 77.3 minutes ) , lower intraoperative blood loss ( 52.7 vs 97.8 mL ) , diminished pain intensity within 48 hours postoperatively , lower prevalence of shoulder-tip pain ( 3.0 % vs 37.5 % ) , shorter time to oral intake ( 4.4 vs 7.3 hours ) , shorter time to ambulation ( 6.1 vs 11.5 hours ) , shorter length of hospital stay , and lower cost ( 1728 vs 2315 ) , respectively ( P < 0.001 for all ) .
-RESULTS	No differences were noted in conversion rate or morbidity except for herniation occurring more often after LTLA than PRA ( 16.1 % vs 0 % , P = 0.022 ) and need for hernia repair ( 12.9 % vs 0 % , P = 0.050 ) , respectively .
-CONCLUSIONS	Both approaches were equally safe .
-CONCLUSIONS	However , outcomes of PRA operations were superior to LTLA in terms of shorter surgery duration , lower blood loss , lower postoperative pain , faster recovery , improved cost-effectiveness , and abolished risk of surgical access site herniation .
-BACKGROUND	NCT01959711 ( http://www.clinicaltrials.gov ) .
-
-###25084699
-BACKGROUND	Our group conducted a cluster-randomised trial in 100 villages of Orissa , India to measure the impact of a rural sanitation intervention implemented under the government of India 's Total Sanitation Campaign , on diarrhoea and soil-transmitted helminth infections .
-BACKGROUND	This paper reports on a process evaluation conducted in the context of the trial .
-METHODS	Process evaluation data were collected through review of key documentation , quantitative surveys , direct observations , and semi-structured interviews with staff from implementing NGOs and community members .
-METHODS	Between March 2011 and March 2012 , trained enumerators recorded observations on latrine construction status every 6-8 weeks in the 50 intervention villages and noted activities reported to have taken place based on NGO staff interviews and review of NGO records .
-METHODS	A survey among 10 % of households in intervention and control villages was conducted to compare levels of awareness of key intervention components .
-METHODS	In addition , 10 % of village water and sanitation committee ( VWSC ) members were interviewed to measure their level of involvement in the intervention delivery .
-RESULTS	The percentage of households with a latrine ( completed or under construction ) increased from 8 % at baseline to 66 % one year after the start of the intervention in March 2012 .
-RESULTS	Almost none of the intervention households recall any form of participatory community-level activities at the start of the programme , although intervention households were generally more aware of the Total Sanitation Campaign ( 91 % versus 49 % , p < 0.001 ) , VWSCs ( 51 % versus 9 % , p < 0.001 ) , adolescent girls groups ( 23 % versus 8 % , p < 0.01 ) , wall paintings ( 44 % versus 7 % , p < 0.001 ) and were more likely to report a household visit on sanitation during the past three months ( 65 % versus 3 % , p < 0.001 ) .
-RESULTS	We found no strong evidence of an association between levels of awareness of or participation in mobilisation activities and levels of latrine coverage in intervention villages .
-CONCLUSIONS	The levels of coverage achieved and the levels of awareness of the mobilisation process in our intervention villages were lower than planned , but similar to those reported elsewhere in India under the TSC .
-CONCLUSIONS	Our process evaluation highlights important gaps between the TSC guidelines and their implementation on the ground .
-BACKGROUND	Number on clinicaltrial.gov : NCT01214785 .
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-###25565416
-BACKGROUND	Nonspecific low back pain ( NLBP ) is the diagnosis for individuals with back pain that has no underlying medical cause ( eg , tumor , infection , fracture , herniated disc , spinal stenosis ) .
-BACKGROUND	The American College of Physicians ( ACP ) and American Pain Society ( APS ) recommend multidisciplinary treatments for NLBP that lasts more than 4 weeks .
-BACKGROUND	This approach , however , is impractical for many physicians to implement , and relatively few providers offer NLBP treatment that meets the joint ACP-APS guidelines .
-OBJECTIVE	This study evaluated the efficacy of a mobile-Web intervention called `` FitBack '' to help users implement self-tailored strategies to manage and prevent NLBP occurrences .
-METHODS	A total of 597 adults were recruited , screened , consented , and assessed online at baseline , at 2 months ( T2 ) , and at 4 months ( T3 ) .
-METHODS	After baseline assessments , participants were randomized into three groups : FitBack intervention , alternative care group that received 8 emails urging participants to link to six Internet resources for NLBP , and control group .
-METHODS	The FitBack group also received weekly email reminder prompts for 8 weeks plus emails to do assessments .
-METHODS	The control group was only contacted to do assessments .
-RESULTS	Users of the FitBack program showed greater improvement compared to the control group in every comparison of the critical physical , behavioral , and worksite outcome measures at 4-month follow-up .
-RESULTS	In addition , users of the FitBack program performed better than the alternative care group on current back pain , behavioral , and worksite outcomes at 4-month follow-up .
-RESULTS	For example , subjects in the control group were 1.7 times more likely to report current back pain than subjects in the FitBack group ; subjects in the alternative care group were 1.6 times more likely to report current back pain at 4-month follow-up .
-RESULTS	Further , the users of the FitBack program showed greater improvement compared to both the control and alternative care groups at 4-month follow-up on patient activation , constructs of the Theory of Planned Behavior , and attitudes toward pain .
-CONCLUSIONS	This research demonstrated that a theoretically based stand-alone mobile-Web intervention that tailors content to users ' preferences and interests can be an effective tool in self-management of low back pain .
-CONCLUSIONS	When viewed from the RE-AIM perspective ( ie , reach , efficacy/effectiveness , adoption , implementation fidelity , and maintenance ) , this study supports the notion that there is considerable value in this type of intervention as a potentially cost-effective tool that can reach large numbers of people .
-CONCLUSIONS	The results are promising considering that the FitBack intervention was neither supported by professional caregivers nor integrated within a health promotion campaign , which might have provided additional support for participants .
-CONCLUSIONS	Still , more research is needed on how self-guided mobile-Web interventions will be used over time and to understand factors associated with continuing user engagement .
-BACKGROUND	Clinicaltrials.gov NCT01950091 ; http://clinicaltrials.gov/ct2/show/NCT01950091 ( Archived by WebCite at http://www.webcitation.org/6TwZucX77 ) .
-
-###25060015
-OBJECTIVE	Our aim was to study the impact of delay from symptom onset to first coronary device oninfarct size and clinical outcomes at 30 days and 1 year in patients with ST-segment elevation myocardial infarction ( STEMI ) treated with primary percutaneous coronary intervention .
-BACKGROUND	Longer delay from symptom onset to reperfusion has been linked to increased mortality and worse clinical outcome .
-BACKGROUND	The mechanisms underpinning this association are not entirely clear .
-METHODS	The INFUSE-AMI trial ( INFUSE-Anterior Myocardial Infarction ) randomized patients with anterior STEMI undergoing primary percutaneous coronary intervention with bivalirudin anticoagulation within 5 h of symptom onset to intralesion ( IL ) bolus abciximab versus no abciximab and to thrombus aspiration versus no aspiration .
-METHODS	The primary endpoint was contrast magnetic resonance infarct size ( IS ) ( percentage of left ventricular mass ) at 30 days .
-METHODS	Time to reperfusion was classified as < 3 versus 3 h.
-RESULTS	There were 280 patients ( 62 % ) with < 3-h delay and 170 patients ( 38 % ) with 3-h delay .
-RESULTS	Patients with longer delay were significantly older , more often women , and diabetic .
-RESULTS	Earlier reperfusion was not associated with higher rates of final Thrombolysis In Myocardial Infarction flow grade 3 or myocardial blush grade 2/3 , but was an independent predictor of smaller IS ( p = 0.02 by multivariable linear regression ) .
-RESULTS	Mortality at 1 year was reduced in patients with shorter delay to reperfusion ( 4.0 % vs. 9.2 % , p = 0.02 ) .
-CONCLUSIONS	In patients with large anterior myocardial infarction undergoing relatively early reperfusion , longer delays to reperfusion were associated with larger IS and 1-year mortality , but notwith reduced reperfusion success .
-CONCLUSIONS	( The INFUSE - Anterior Myocardial Infarction [ AMI ] Study ; NCT00976521 ) .
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-###25527751
-BACKGROUND	Fat accumulation in nonadipose tissue is linked to insulin resistance and metabolic diseases .
-BACKGROUND	Earlier studies have shown that hepatic lipid accumulation can occur after 4 d of a high-fat diet in humans , and this fat accumulation can be blunted by the ingestion of additional proteins .
-OBJECTIVE	In this study , we explored whether a single high-fat meal increased the lipid content in liver and skeletal muscle as measured by using in vivo proton magnetic resonance spectroscopy ( H-MRS ) and whether the addition of protein can modulate the postprandial ectopic lipid storage .
-METHODS	Intrahepatic lipid ( IHL ) and intramyocellular lipid ( IMCL ) concentrations were determined by using H-MRS before and 3 and 5 h after a high-fat with added protein meal ( 61.5 % of energy from fat ) or a high-fat without added protein meal ( mean SEM : 51.1 7.9 g of protein ; 191.9 9.9 kcal added ) in a randomized crossover study .
-METHODS	IHL and IMCL concentrations were converted to absolute concentrations ( g/kg wet weight ) by using water as an internal reference .
-RESULTS	Nine lean , healthy subjects [ 6 men and 3 women ; mean ( SD ) age : 22.7 3.0 y ; mean body mass index ( in kg/m ) : 21.8 1.8 ] were included in this study .
-RESULTS	IHL concentrations increased 20 % ( P < 0.01 ) at 3 h after the meal and did not further increase after 5 h.
-RESULTS	In contrast , IMCL concentrations were not altered during the postprandial period ( P = 0.74 ) .
-RESULTS	The addition of protein to a single high-fat meal did not change the postprandial accumulation of fat in the liver ( P = 0.93 ) or skeletal muscle ( P = 0.84 ) .
-CONCLUSIONS	In this study , we showed that a single energy-dense , high-fat meal induced net lipid accumulation in the liver , which was detected by using in vivo H-MRS .
-CONCLUSIONS	This noninvasive approach might bring new opportunities to study postprandial hepatic lipid dynamics .
-CONCLUSIONS	The addition of protein did not change the ectopic lipid retention after a single high-fat meal .
-
-###24434070
-BACKGROUND	Rates of self-harm are high and have recently increased .
-BACKGROUND	This trend and the repetitive nature of self-harm pose a significant challenge to mental health services .
-OBJECTIVE	To determine the efficacy of a structured group problem-solving skills training ( PST ) programme as an intervention approach for self-harm in addition to treatment as usual ( TAU ) as offered by mental health services .
-METHODS	A total of 433 participants ( aged 18-64 years ) were randomly assigned to TAU plus PST or TAU alone .
-METHODS	Assessments were carried out at baseline and at 6-week and 6-month follow-up and repeated hospital-treated self-harm was ascertained at 12-month follow-up .
-RESULTS	The treatment groups did not differ in rates of repeated self-harm at 6-week , 6-month and 12-month follow-up .
-RESULTS	Both treatment groups showed significant improvements in psychological and social functioning at follow-up .
-RESULTS	Only one measure ( needing and receiving practical help from those closest to them ) showed a positive treatment effect at 6-week ( P = 0.004 ) and 6-month ( P = 0.01 ) follow-up .
-RESULTS	Repetition was not associated with waiting time in the PST group .
-CONCLUSIONS	This brief intervention for self-harm is no more effective than treatment as usual .
-CONCLUSIONS	Further work is required to establish whether a modified , more intensive programme delivered sooner after the index episode would be effective .
-
-###24835837
-OBJECTIVE	Assimilating the diagnosis complete spinal cord injury ( SCI ) takes time and is not easy , as patients know that there is no ` cure ' at the present time .
-OBJECTIVE	Brain-computer interfaces ( BCIs ) can facilitate daily living .
-OBJECTIVE	However , inter-subject variability demands measurements with potential user groups and an understanding of how they differ to healthy users BCIs are more commonly tested with .
-OBJECTIVE	Thus , a three-class motor imagery ( MI ) screening ( left hand , right hand , feet ) was performed with a group of 10 able-bodied and 16 complete spinal-cord-injured people ( paraplegics , tetraplegics ) with the objective of determining what differences were present between the user groups and how they would impact upon the ability of these user groups to interact with a BCI .
-METHODS	Electrophysiological differences between patient groups and healthy users are measured in terms of sensorimotor rhythm deflections from baseline during MI , electroencephalogram microstate scalp maps and strengths of inter-channel phase synchronization .
-METHODS	Additionally , using a common spatial pattern algorithm and a linear discriminant analysis classifier , the classification accuracy was calculated and compared between groups .
-RESULTS	It is seen that both patient groups ( tetraplegic and paraplegic ) have some significant differences in event-related desynchronization strengths , exhibit significant increases in synchronization and reach significantly lower accuracies ( mean ( M ) = 66.1 % ) than the group of healthy subjects ( M = 85.1 % ) .
-CONCLUSIONS	The results demonstrate significant differences in electrophysiological correlates of motor control between healthy individuals and those individuals who stand to benefit most from BCI technology ( individuals with SCI ) .
-CONCLUSIONS	They highlight the difficulty in directly translating results from healthy subjects to participants with SCI and the challenges that , therefore , arise in providing BCIs to such individuals .
-
-###26218728
-BACKGROUND	Patient satisfaction with treatment is an important outcome in facial aesthetic medicine .
-OBJECTIVE	To evaluate subject satisfaction with onabotulinumtoxinA treatment of glabellar lines ( GL ) and crow 's feet lines ( CFL ) using the validated Facial Line Satisfaction Questionnaire ( FLSQ ) .
-METHODS	In this randomized double-blind study , subjects with moderate/severe GL and CFL received onabotulinumtoxinA ( 20 U , GL ; 24 U , CFL ) or placebo .
-METHODS	Over 120 days , the following were assessed : satisfaction , achievement of treatment expectations , satisfaction with duration of treatment ( FLSQ ) , severity of GL and CFL ( Facial Wrinkle Scale [ FWS ] ) , and aesthetic improvement ( Global Aesthetic Improvement Scale ) .
-RESULTS	Satisfaction in the per-protocol population was significantly greater at Day 60 in the onabotulinumtoxinA group ( n = 60 ) compared with placebo ( n = 57 ) for GL ( 81.7 % vs 0 % ; p < .001 ) .
-RESULTS	Most subjects treated with onabotulinumtoxinA remained satisfied up to 120 days .
-RESULTS	Achievement of treatment expectations ( 86.7 % ; Day 60 ) , satisfaction ( 81.7 % ; Day 60 ) , and satisfaction with the duration of treatment ( 61.6 % ; Day 90 ) were significantly better with onabotulinumtoxinA than placebo ( p < .001 ) for GL and CFL combined .
-RESULTS	Efficacy ( FWS ) and aesthetic improvement were observed in most subjects at Days 30 and 60 , respectively .
-CONCLUSIONS	High satisfaction rates are achieved and sustained in subjects treated with onabotulinumtoxinA for GL and CFL combined .
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-###24445981
-OBJECTIVE	To compare efficacy and safety of chloral hydrate ( CH ) , chloral hydrate and promethazine ( CH + P ) and chloral hydrate and hydroxyzine ( CH + H ) in electroencephalography ( EEG ) sedation .
-METHODS	In a parallel single-blinded randomized clinical trial , ninety 1-7 y-old uncooperative kids who were referred to Pediatric Neurology Clinic of Shahid Sadoughi University , Yazd , Iran from April through August 2012 , were randomly assigned to receive 40mg/kg of chloral hydrate or 40mg/kg of chloral hydrate and 1mg/kg of promethazine or 40mg/kg of chloral hydrate and 2mg/kg of hydroxyzine .
-METHODS	The primary endpoint was efficacy in sufficient sedation ( obtaining four Ramsay sedation score ) and successful completion of EEG .
-METHODS	Secondary endpoint was clinical adverse events .
-RESULTS	Thirty nine girls ( 43.3 % ) and 51 boys ( 56.7 % ) with mean age of 3.341.47 y were assessed .
-RESULTS	Sufficient sedation and completion of EEG were achieved in 70 % ( N = 21 ) of chloral hydrate group , in 83.3 % ( N = 25 ) of CH + H group and in 96.7 % ( N = 29 ) of CH + P group ( p = 0.02 ) .
-RESULTS	Mild clinical adverse events including vomiting [ 16.7 % ( N = 5 ) in CH , 6.7 % ( N = 2 ) in CH + P , 6.7 % ( N = 2 ) in CH + H ] , agitation in 3.3 % of CH + P ( N = 1 ) group and mild transient hypotension in 3.3 % of CH + H ( N = 1 ) group occurred .
-RESULTS	Safety of these three sedation regimens was not statistically significant different ( p = 0.14 ) .
-CONCLUSIONS	Combination of chloral hydrate-antihistamines can be used as the most effective and safe sedation regimen in drug induced sleep electroencephalography of kids .
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-###24703570
-BACKGROUND	The relationship of clinical variables for cognitive functioning and other variables such as multiple neuropsychiatric symptoms and quality of life are usually analyzed bivariately and multivariately .
-BACKGROUND	In randomized controlled trials analyses are mostly performed on individual outcome variables .
-BACKGROUND	To unravel interdependencies of determinants and outcome variables , Structural Equation Modeling ( SEM ) was applied .
-METHODS	Using SEM , we explored interdependencies of clinical determinants ( MMSE , BI , and NPI-sum severity ) and quality of life ( EQ5D ) in psychogeriatric patients ( including dementia ) suffering from cognitive problems and multiple neuropsychiatric symptoms .
-RESULTS	MMSE and BI showed direct and indirect impact on EQ5D , but the association with NPI-sum severity was minor .
-RESULTS	The identified model showed that R ( 2 ) of EQ5D varied from 0.21 to 0.48 .
-CONCLUSIONS	This clinical-empirical study showed that SEM could be utilized to unravel and identify a model of complex direct and indirect effects of MMSE and BI on EQ5D .
-CONCLUSIONS	In relation to NPI-sum severity , however , the validity of EQ5D seemed insufficient in psychogeriatric patients .
-CONCLUSIONS	Consequently , the cost-benefit analyses and cost-effectiveness analyses using quality-adjusted life-year measures of an intervention in psychogeriatric patients with multiple neuropsychiatric symptoms , based on EQ5D , are considered questionable .
-CONCLUSIONS	Construction of a quality of life instrument that is more sensitive with regard to multiple neuropsychiatric symptoms in psychogeriatric patients is highly recommended .
-
-###24752034
-BACKGROUND	Motive-oriented therapeutic relationship ( MOTR ) was postulated to be a particularly helpful therapeutic ingredient in the early treatment phase of patients with personality disorders , in particular with borderline personality disorder ( BPD ) .
-BACKGROUND	The present randomized controlled study using an add-on design is the first study to test this assumption in a 10-session general psychiatric treatment with patients presenting with BPD on symptom reduction and therapeutic alliance .
-METHODS	A total of 85 patients were randomized .
-METHODS	They were either allocated to a manual-based short variant of the general psychiatric management ( GPM ) treatment ( in 10 sessions ) or to the same treatment where MOTR was deliberately added to the treatment .
-METHODS	Treatment attrition and integrity analyses yielded satisfactory results .
-RESULTS	The results of the intent-to-treat analyses suggested a global efficacy of MOTR , in the sense of an additional reduction of general problems , i.e. symptoms , interpersonal and social problems ( F1 , 73 = 7.25 , p < 0.05 ) .
-RESULTS	However , they also showed that MOTR did not yield an additional reduction of specific borderline symptoms .
-RESULTS	It was also shown that a stronger therapeutic alliance , as assessed by the therapist , developed in MOTR treatments compared to GPM ( Z55 = 0.99 , p < 0.04 ) .
-CONCLUSIONS	These results suggest that adding MOTR to psychiatric and psychotherapeutic treatments of BPD is promising .
-CONCLUSIONS	Moreover , the findings shed additional light on the perspective of shortening treatments for patients presenting with BPD .
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-###26255456
-OBJECTIVE	verification of a hypothesis assuming that 5-HT3 receptor blockade by intravenous administration of ondansetron reduces the incidence of hypotension and bradycardia in patients undergoing spinal anaesthesia for Caesarean section .
-METHODS	The study design was approved by the Bioethics Committee and included 72 patients undergoing elective Caesarean section , randomly assigned to ondansetron group ( group 0 ) or placebo group ( group P ) .
-METHODS	Finally group 0 encompassed 35 patients administered ondansetron 8 mg i.v. dissolved in 10 ml 0.9 % NaCl whereas group P consisted of 34 patients receiving 0.9 % NaCl 10 mg .
-METHODS	Systolic and diastolic pressures were measured every 2 minutes since the onset of anaesthesia .
-METHODS	Heart rate ( HR ) was monitored continuously The criterion of hypotension requiring ephedrine was a decrease in systolic pressure by 20 % compared to its baseline value or a decrease in systolic pressure below 90 mm Hg .
-METHODS	The criterion of bradycardia was a decrease in HR below 60/min .
-RESULTS	Hypotension was observed in 14 group 0 patients ( 39 % ) and in 15 group P patients ( 44 % ) ; the difference was not statistically significant .
-RESULTS	Bradycardia was noted in 1 group 0 patient ( 3 % ) and in 2 group P patients ( 6 % ) ; the difference was not statistically significant .
-CONCLUSIONS	A hypothesis assuming a reduction in pressure following subarachnoid anaesthesia for Caesarean section after the administration of 8 mg of ondansetron was not confirmed .
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-###24330220
-OBJECTIVE	Access , enrollment , and engagement with primary and specialty health care services present significant challenges for rural populations worldwide .
-OBJECTIVE	The Alabama Veterans Rural Health Initiative evaluated an innovative outreach intervention combining motivational interviewing , patient navigation , and health services education to promote utilization of the United States Veterans Administration Healthcare System ( VA ) by veterans who live in rural locations .
-METHODS	Community outreach workers completed the intervention and assessment , enrolling veterans from 31 counties in a southern state .
-METHODS	A total 203 participants were randomized to either an enhanced enrollment and engagement outreach condition ( EEE , n = 101 ) or an administrative outreach ( AO , n = 102 ) condition .
-RESULTS	EEE participants enrolled and attended VA appointments at higher rates and within fewer days than those who received AO .
-RESULTS	Eighty-seven percent of EEE veterans attended an appointment within 6 months , compared to 58 % of AO veterans ( P < .0001 ) .
-RESULTS	The median time to first appointment was 12 days for the EEE group and 98 days for the AO group ( P < .0001 ) .
-RESULTS	Additionally , a race by outreach group interaction emerged : black and white individuals benefited equally from the EEE intervention ; however , black individuals who received AO took significantly longer to attend appointments than their white counterparts .
-CONCLUSIONS	Results provide needed empirical support for a specific outreach intervention that speeds enrollment and engagement for rural individuals in VA services .
-CONCLUSIONS	Planned interventions to improve service utilization should ameliorate ambivalence about accessing health care in addition to addressing traditional systems or environmental-level barriers .
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-###24937476
-BACKGROUND	Ex vivo , bronchial epithelial cells from people with asthma are more susceptible to rhinovirus infection caused by deficient induction of the antiviral protein , IFN - .
-BACKGROUND	Exogenous IFN - restores antiviral activity .
-OBJECTIVE	To compare the efficacy and safety of inhaled IFN - with placebo administered to people with asthma after onset of cold symptoms to prevent or attenuate asthma symptoms caused by respiratory viruses .
-METHODS	A total of 147 people with asthma on inhaled corticosteroids ( British Thoracic Society Steps 2-5 ) , with a history of virus-associated exacerbations , were randomized to 14-day treatment with inhaled IFN - ( n = 72 ) or placebo ( n = 75 ) within 24 hours of developing cold symptoms and were assessed clinically , with relevant samples collected to assess virus infection and antiviral responses .
-RESULTS	A total of 91 % of randomized patients developed a defined cold .
-RESULTS	In this modified intention-to-treat population , asthma symptoms did not get clinically significantly worse ( mean change in six-item Asthma Control Questionnaire < 0.5 ) and IFN - treatment had no significant effect on this primary endpoint , although it enhanced morning peak expiratory flow recovery ( P = 0.033 ) , reduced the need for additional treatment , and boosted innate immunity as assessed by blood and sputum biomarkers .
-RESULTS	In an exploratory analysis of the subset of more difficult-to-treat , Step 4-5 people with asthma ( n = 27 IFN - ; n = 31 placebo ) , Asthma Control Questionnaire-6 increased significantly on placebo ; this was prevented by IFN - ( P = 0.004 ) .
-CONCLUSIONS	Although the trial did not meet its primary endpoint , it suggests that inhaled IFN - is a potential treatment for virus-induced deteriorations of asthma in difficult-to-treat people with asthma and supports the need for further , adequately powered , trials in this population .
-CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 01126177 ) .
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-###24947034
-BACKGROUND	Pelvic organ prolapse ( POP ) increases in prevalence with age ; recurrence after surgical repair is common .
-OBJECTIVE	The objective of the study was to determine the effects of local estrogen treatment on connective tissue synthesis and breakdown in the vaginal wall of postmenopausal women planning surgical repair of POP .
-METHODS	This was a randomized trial .
-METHODS	The study was conducted at an academic tertiary medical center .
-METHODS	Postmenopausal women with a uterus and symptomatic anterior and/or apical prolapse at stage 2 or greater participated in the study .
-METHODS	Estrogen ( Premarin ) or placebo cream for 6 weeks preoperatively was the intervention .
-METHODS	Full-thickness anterior apical vaginal wall biopsies were obtained at the time of hysterectomy and analyzed for mucosa and muscularis thickness , connective tissue synthesis , and degradation .
-METHODS	Serum levels of estrone and 17-estradiol were analyzed at baseline and the day of surgery using highly sensitive liquid chromatography-tandem mass spectrometry .
-RESULTS	Fifteen women per group ( n = 30 total ) were randomized ; 13 per group underwent surgery .
-RESULTS	Among drug-adherent participants ( n = 8 estrogen , n = 13 placebo ) , epithelial and muscularis thickness was increased 1.8 - and 2.7-fold ( P = .002 and P = .088 , respectively ) by estrogen .
-RESULTS	Collagen types 11 and 12 mRNA increased 6.0 - and 1.8-fold in the vaginal muscularis ( P < .05 for both ) ; collagen type Ia protein increased 9-fold in the muscularis ( P = .012 ) , whereas collagen III was not changed significantly .
-RESULTS	MMP-12 ( human macrophage elastase ) mRNA was suppressed in the vaginal mucosa from estrogen-treated participants ( P = .011 ) , and matrix metalloprotease-9 activity was decreased 6-fold in the mucosa and 4-fold in the muscularis ( P = .02 ) .
-RESULTS	Consistent with menopausal norms , serum estrone and 17-estradiol were low and did not differ among the two groups .
-CONCLUSIONS	Vaginal estrogen application for 6 weeks preoperatively increased synthesis of mature collagen , decreased degradative enzyme activity , and increased thickness of the vaginal wall , suggesting this intervention improves both the substrate for suture placement at the time of surgical repair and maintenance of connective tissue integrity of the pelvic floor .
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-###24517384
-BACKGROUND	There is a need for psychosocial interventions for men with prostate cancer to promote adaptive coping with the challenges and distress associated with diagnosis , treatment and recovery .
-BACKGROUND	In addition , interventions are needed that help to overcome barriers to psychosocial treatment such as limited face-to-face psychosocial support services , a shortage of adequately trained professionals , geographical distance , perceived and personal stigma and a preference for consumer-centric and self-directed learning .
-BACKGROUND	My Road Ahead is an online cognitive behaviour therapy ( CBT ) intervention for prostate cancer .
-BACKGROUND	This protocol describes a randomised controlled trial ( RCT ) that will evaluate the efficacy of this online intervention alone , the intervention in combination with a moderated online forum , and the moderated online forum alone .
-METHODS	This study utilises a RCT design with three groups receiving : 1 ) the 6-module My Road Ahead intervention alone ; 2 ) the My Road Ahead intervention plus a moderated online forum ; and 3 ) the moderated online forum alone .
-METHODS	It is expected that 150 men with localised prostate cancer will be recruited into the RCT .
-METHODS	Online measures will assess men 's psychological distress as well as sexual and relationship adjustment at baseline , post-intervention , 3 month follow-up and 6 month follow-up .
-METHODS	The study is being conducted in Australia and participants will be recruited from April 2012 to Feb 2014 .
-METHODS	The primary aim of this study is to evaluate the efficacy of My Road Ahead in reducing psychological distress .
-CONCLUSIONS	To our knowledge , My Road Ahead is the first self-directed online psychological intervention developed for men who have been treated for localised prostate cancer .
-CONCLUSIONS	The RCT will assess the efficacy of this intervention in improving psychological well-being , sexual satisfaction , relationship satisfaction and overall quality of life .
-CONCLUSIONS	If successful , this intervention could provide much needed support to men receiving treatment for localised prostate cancer in a highly accessible manner .
-BACKGROUND	Australian New Zealand Clinical Trials Registry Identifier : ACTRN12611000278932 .
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-###24755339
-BACKGROUND	Neutrophil gelatinase-associated lipocalin ( NGAL ) is a biomarker of acute kidney injury ( AKI ) , and levels reflect severity of disease in critically ill patients .
-BACKGROUND	However , continuous venovenous hemofiltration ( CVVH ) may affect plasma levels by clearance or release of NGAL by activated neutrophils in the filter , dependent on the anticoagulation regimen applied .
-BACKGROUND	We therefore studied handling of NGAL by CVVH in patients with AKI .
-METHODS	Immediately before initiation of CVVH , prefilter blood was drawn .
-METHODS	After 10 , 60 , 180 , and 720 minutes of CVVH , samples were collected from pre - and postfilter ( in - and outlet ) blood and ultrafiltrate .
-METHODS	CVVH with the following anticoagulation regimens was studied : no anticoagulation in case of a high bleeding tendency ( n = 13 ) , unfractionated heparin ( n = 8 ) , or trisodium citrate ( n = 21 ) .
-METHODS	NGAL levels were determined with enzyme-linked immunosorbent assay ( ELISA ) .
-RESULTS	Concentrations of NGAL at inlet and outlet were similar , and concentrations did not change over time in any of the anticoagulation groups ; thus no net removal or production of NGAL occurred .
-RESULTS	Concentrations of NGAL at inlet correlated with disease severity at initiation of CVVH and at the end of a CVVH run .
-RESULTS	Concentrations of NGAL in the ultrafiltrate were lower with citrate-based CVVH ( P = 0.03 ) and decreased over time , irrespective of anticoagulation administered ( P < 0.001 ) .
-RESULTS	The sieving coefficient and clearance of NGAL were low and decreased over time ( P < 0.001 ) .
-CONCLUSIONS	The plasma level and biomarker value of NGAL in critically ill patients with AKI are not affected by CVVH , because clearance by the filter was low .
-CONCLUSIONS	Furthermore , no evidence exists for intrafilter release of NGAL by neutrophils , irrespective of the anticoagulation method applied .
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-###24582087
-OBJECTIVE	To improve the clinical course of ulcerative colitis ( UC ) , more accurate serum diagnostic and assessment methods are required .
-OBJECTIVE	We used serum metabolomics to develop diagnostic and assessment methods for UC .
-METHODS	Sera from UC patients , Crohn 's disease ( CD ) patients , and healthy volunteers ( HV ) were collected at multiple institutions .
-METHODS	The UC and HV were randomly allocated to the training or validation set , and their serum metabolites were analyzed by gas chromatography mass spectrometry ( GC/MS ) .
-METHODS	Using the training set , diagnostic and assessment models for UC were established by multiple logistic regression analysis .
-METHODS	Then , the models were assessed using the validation set .
-METHODS	Additionally , to establish a diagnostic model for discriminating UC from CD , the CD patients ' data were used .
-RESULTS	The diagnostic model for discriminating UC from HV demonstrated an AUC of 0.988 , 93.33 % sensitivity , and 95.00 % specificity in the training set and 95.00 % sensitivity and 98.33 % specificity in the validation set .
-RESULTS	Another model for discriminating UC from CD exhibited an AUC of 0.965 , 85.00 % sensitivity , and 97.44 % specificity in the training set and 83.33 % sensitivity in the validation set .
-RESULTS	The model for assessing UC showed an AUC of 0.967 , 84.62 % sensitivity , and 88.23 % specificity in the training set and 84.62 % sensitivity , 91.18 % specificity , and a significant correlation with the clinical activity index ( rs = 0.7371 , P < 0.0001 ) in the validation set .
-CONCLUSIONS	Our models demonstrated high performance and might lead to the development of a novel treatment selection method based on UC condition .
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-###24931747
-BACKGROUND	In endemic areas , gestational malaria is responsible for low birth weight and maternal anaemia .
-BACKGROUND	Quinine is the reference treatment for acute malaria in pregnant women , irrespective of term .
-BACKGROUND	However , quinine administration is associated with various side-effects .
-BACKGROUND	We evaluated the impact of the homeopathic medicine China rubra 7CH on the side-effects of quinine used as treatment for acute malaria in pregnant women in Cotonou , Benin .
-METHODS	This prospective , comparative , randomised study was carried out between June and December 2007 in the Saint Jean-Baptiste Medical Centre , Cotonou .
-METHODS	Women were included if they were > 3 months pregnant and had a clinical diagnosis of malaria confirmed by a positive thick blood smear .
-METHODS	The study population was divided into two groups : ( i ) patients who presented between the 1st and 15th of each month and who received China rubra 7CH plus quinine ( China group ) ; and ( ii ) patients who presented from the 16th to the end of each month and who received treatment with quinine only ( Standard group ) .
-METHODS	The aim was to compare the frequency of side-effects of quinine in the two groups until day 6 after the start of treatment .
-METHODS	Neither the patients nor the care givers were blinded to study treatment .
-METHODS	Statistical comparison of the two groups was carried out with an alpha risk fixed at 5 % .
-RESULTS	211 women were recruited : 105 received quinine plus China rubra 7CH ( China group ) and 106 received quinine only ( Standard group ) .
-RESULTS	A decrease in proportion of patients presenting with side-effects was observed in the China group from day 0 to day 6 of follow-up ( 53.9 % -23.3 % ) whereas the proportion of patients with side-effects in the Standard group did not change significantly ( 85.9 % on day 0 vs. 82.5 % on day 6 ) .
-RESULTS	Ninety-six ( 72.4 % ) patients in the China group and 103 ( 97.2 % ) in the Standard group reported at least one side-effect during follow-up ( p < 0.0001 ) .
-RESULTS	The most frequently reported side-effects were tinnitus , dizziness and asthenia .
-CONCLUSIONS	This preliminary study shows the interest of China rubra 7CH in limiting the side-effects of quinine used for the treatment of acute malaria in pregnant women .
-
-###24776754
-OBJECTIVE	Growth Hormone ( GH ) dosage in childhood is adjusted for body size , but there is no consensus whether body weight ( BW ) or body surface area ( BSA ) should be used .
-OBJECTIVE	We aimed at comparing the biological effect and cost-effectiveness of GH treatment dosed per m2 BSA in comparison with dosing per kg BW in girls with Turner syndrome ( TS ) .
-METHODS	Serum IGF-I , GH dose , and adult height gain ( AHG ) from girls participating in two Dutch and five Swedish studies on the efficacy of GH were analyzed , and the cumulative GH dose and costs were calculated for both dose adjustment methods .
-METHODS	Additional medication included estrogens ( if no spontaneous puberty occurred ) and oxandrolone in some studies .
-RESULTS	At each GH dose , the serum IGF-I standard deviation score remained stable over time after an initial increase after the start of treatment .
-RESULTS	On a high dose ( at 1 m2 equivalent to 0.056-0 .067 mg/kg/day ) , AHG was at least equal on GH dosed per m2 BSA compared with dosing per kg BW .
-RESULTS	The cumulative dose and cost were significantly lower if the GH dose was adjusted for m2 BSA .
-CONCLUSIONS	Dosing GH per m2 BSA is at least as efficacious as dosing per kg BW , and is more cost-effective .
-
-###25441435
-BACKGROUND	Planning for renal replacement therapy , such as referral for arteriovenous fistula placement and transplantation , often is guided by level of estimated glomerular filtration rate ( eGFR ) .
-BACKGROUND	The use of risk equations might enable more accurate estimation of time to end-stage renal disease ( ESRD ) , thus improving patient care .
-METHODS	Prospective observational study .
-METHODS	1,094 participants in the African American Study of Kidney Disease and Hypertension ( AASK ) cohort .
-METHODS	Age , sex , urine protein-creatinine ratio 1g/g , APOL1 high-risk status , and 3-year antecedent eGFR decline .
-RESULTS	Cumulative incidence of ESRD from 5 different starting points : eGFR of 30 and 15mL/min/1 .73 m ( 2 ) and 1-year ESRD risk of 5 % , 10 % , and 20 % , estimated by a published 4-variable kidney failure risk equation .
-RESULTS	566 participants developed eGFR of 30mL/min/1 .73 m ( 2 ) , 244 developed eGFR of 15mL/min/1 .73 m ( 2 ) , and 437 , 336 , and 259 developed 1-year ESRD risks of 5 % , 10 % , and 20 % , respectively .
-RESULTS	The 1-year cumulative incidence of ESRD was 4.3 % from eGFR of 30mL/min/1 .73 m ( 2 ) , 49.0 % from eGFR of 15mL/min/1 .73 m ( 2 ) , 6.7 % from 5 % ESRD risk , 15.0 % from 10 % ESRD risk , and 29 % from 20 % ESRD risk .
-RESULTS	From eGFR of 30mL/min/1 .73 m ( 2 ) , there were several risk factors that predicted ESRD risk .
-RESULTS	From eGFR of 15mL/min/1 .73 m ( 2 ) , only level of proteinuria did ; median time to ESRD was 9 and 19 months in those with higher and lower proteinuria , respectively .
-RESULTS	Median times were less variable from corresponding ESRD risk thresholds .
-RESULTS	For example , median times to ESRD from 20 % ESRD risk were 22 and 25 months among those with higher and lower proteinuria , respectively .
-CONCLUSIONS	Relatively homogeneous population of African Americans with hypertensive kidney disease .
-CONCLUSIONS	Results of the present study suggest the potential benefit of incorporating kidney failure risk equations into clinical care , with selection of a specific threshold guided by its intended use .
-
-###24892803
-BACKGROUND	The Composite Variability Index ( CVI ) , derived from the electroencephalogram , was developed to assess the antinociception-nociception balance , whereas the Bispectral Index ( BIS ) was developed to assess the hypnotic state during anesthesia .
-BACKGROUND	We studied the relationships between these indices , level of hypnosis ( BIS level ) , and antinociception ( predicted remifentanil effect-site concentrations , CeREMI ) before and after stimulation .
-BACKGROUND	Also , we measured their association with movement in response to a noxious stimulus .
-METHODS	We randomized 120 patients to one of 12 groups targeting different hypnotic levels ( BIS 70 , 50 , and 30 ) and various CeREMI ( 0 , 2 , 4 , or 6 ng/mL ) .
-METHODS	At pseudo-steady state , baseline values were observed , and a series of stimuli were applied .
-METHODS	Changes in BIS , CVI , heart rate ( HR ) , and mean arterial blood pressure ( MAP ) between baseline and response period were analyzed in relation to level of hypnosis , antinociception , and somatic response to the stimuli .
-RESULTS	CVI and BIS more accurately correlate with somatic response to an Observer Assessment of Alertness and Sedation-noxious stimulation than HR , MAP , CeREMI , and propofol effect-site concentration ( Tukey post hoc tests P < 0.01 ) .
-RESULTS	Change in CVI is more adequate to monitor response to stimulation than changes in BIS , HR , or MAP ( as described by the Mathews Correlation Coefficient with significance level set at P < 0.001 ) .
-RESULTS	In contrast , none of the candidate analgesic state indices was uniquely related to a specific opioid concentration and is extensively influenced by the hypnotic state as measured by BIS .
-CONCLUSIONS	CVI appears to correlate with somatic responses to noxious stimuli .
-CONCLUSIONS	However , unstimulated CVI depends more on hypnotic drug effect than on opioid concentration .
-
-###24931591
-OBJECTIVE	Acclimatization at natural altitude effectively prevents acute mountain sickness ( AMS ) .
-OBJECTIVE	It is , however , unknown whether prevention of AMS is also possible by only sleeping in normobaric hypoxia .
-METHODS	In a placebo-controlled , double-blind study 76 healthy unacclimatized male subjects , aged 18 to 50 years , slept for 14 consecutive nights at either a fractional inspired oxygen ( Fio2 ) of 0.14 to 0.15 ( average target altitude 3043 m ; treatment group ) or 0.209 ( control group ) .
-METHODS	Four days later , AMS scores and incidence of AMS were assessed during a 20-hour exposure in normobaric hypoxia at Fio2 = 0.12 ( equivalent to 4500 m ) .
-RESULTS	Because of technical problems with the nitrogen generators , target altitude was not achieved in the tents and only 21 of 37 subjects slept at an average altitude considered sufficient for acclimatization ( > 2200 m ; average , 2600 m ) .
-RESULTS	Therefore , in a subgroup analysis these subjects were compared with the 21 subjects of the control group with the lowest sleeping altitude .
-RESULTS	This analysis showed a significantly lower AMS-C score ( 0.38 ; 95 % CI , 0.21 to 0.54 ) vs 1.10 ; 95 % CI , 0.57 to 1.62 ; P = .04 ) and lower Lake Louise Score ( 3.1 ; 95 % CI , 2.2 to 4.1 vs 5.1 ; 95 % CI , 3.6 to 6.6 ; P = .07 ) for the treatment subgroup .
-RESULTS	The incidence of AMS defined as an AMS-C score greater than 0.70 was also significantly lower ( 14 % vs 52 % ; P < .01 ) .
-CONCLUSIONS	Sleeping 14 consecutive nights in normobaric hypoxia ( equivalent to 2600 m ) reduced symptoms and incidence of AMS 4 days later on exposure to 4500 m.
-
-###24302181
-OBJECTIVE	Sevoflurane is an ideal agent for anesthesia since its respiratory irritant effect is minimal during mask induction .
-OBJECTIVE	Emergence agitation ( EA ) is a common problem after anesthesia with sevoflurane .
-OBJECTIVE	In this study it was aimed to compare the effects of dexmedetomidine and remifentanyl on emergence agitation after sevoflurane anesthesia in adults undergoing septoplasty operation .
-METHODS	This prospective , randomized , double-blind study was conducted in Yenimahalle State Hospital after obtaining local Ethics Committee approval and patient 's written informed consent .
-METHODS	The patients were randomized into dexmedetomidine and remifentanyl groups .
-METHODS	Hemodynamic parameters including heart rat , Mean arterial pressure , and sPO2 were recorded .
-METHODS	The patients were followed for 1 hour at the recovery room .
-METHODS	Categorical data was analyzed using c2 test .
-METHODS	Hemodynamic data was evaluated using unpaired t test for intergroup and paired t-test for within group comparisons .
-METHODS	Data not normally distributed was compared using Mann Whitney U test .
-METHODS	p < 0.05 was considered statistically significant .
-RESULTS	Demographic data were similar in both groups ( p > 0.05 ) .
-RESULTS	Riker score was similar in both groups .
-RESULTS	VAS score was also not significantly different between both groups at the recovery room .
-CONCLUSIONS	Our study demonstrated that Dexmedotimidine and Remifentanyl had equal effectiveness in reducing emergence agitation in patients undergoing septoplasty under Sevoflurane anesthesia .
-
-###24831368
-OBJECTIVE	To analyze the analysis of recurrence rates of single versus double burr holes in patients with subacute and chronic subdural hematomas .
-METHODS	The study was a prospective randomized controlled trial on patients with subacute and chronic subdural hematomas .
-METHODS	Collections with membranes or septae were excluded from the study .
-METHODS	A written consent was taken from the patient or patient party after explaining the procedure .
-METHODS	A total of 254 patients were enrolled in the study over a period of 18-months in the Department of Neurosurgery , Sheri-Kashmir-Institute of Medical Sciences , Srinagar , Kashmir .
-RESULTS	Recurrence rates in single and double-burr-hole groups were 6.15 % and 4.83 % respectively , which was not statistically significant .
-CONCLUSIONS	Most of the subdural hematomas can be dealt by single burr-hole drainage .
-
-###24508386
-OBJECTIVE	Abdominal adiposity is associated with low BMD and decreased growth hormone ( GH ) secretion , an important regulator of bone homeostasis .
-OBJECTIVE	The purpose of our study was to determine the effects of a short course of GH on markers of bone turnover and bone marrow fat in premenopausal women with abdominal adiposity .
-METHODS	In a 6-month , randomized , double-blind , placebo-controlled trial we studied 79 abdominally obese premenopausal women ( 21-45 y ) who underwent daily sc injections of GH vs. placebo .
-METHODS	Main outcome measures were body composition by DXA and CT , bone marrow fat by proton MR spectroscopy , P1NP , CTX , 25 ( OH ) D , hsCRP , undercarboxylated osteocalcin ( ucOC ) , preadipocyte factor 1 ( Pref 1 ) , apolipoprotein B ( ApoB ) , and IGF-1 .
-RESULTS	GH increased IGF-1 , P1NP , 25 ( OH ) D , ucOC , bone marrow fat and lean mass , and decreased abdominal fat , hsCRP , and ApoB compared with placebo ( p < 0.05 ) .
-RESULTS	There was a trend toward an increase in CTX and Pref-1 .
-RESULTS	Among all participants , a 6-month increase in IGF-1 correlated with 6-month increase in P1NP ( p = 0.0005 ) , suggesting that subjects with the greatest increases in IGF-1 experienced the greatest increases in bone formation .
-RESULTS	A six-month decrease in abdominal fat , hsCRP , and ApoB inversely predicted 6-month change in P1NP , and 6-month increase in lean mass and 25 ( OH ) D positively predicted 6-month change in P1NP ( p0 .05 ) , suggesting that subjects with greatest decreases in abdominal fat , inflammation and ApoB , and the greatest increases in lean mass and 25 ( OH ) D experienced the greatest increases in bone formation .
-RESULTS	A six-month increase in bone marrow fat correlated with 6-month increase in P1NP ( trend ) , suggesting that subjects with the greatest increases in bone formation experienced the greatest increases in bone marrow fat .
-RESULTS	Forward stepwise regression analysis indicated that increase in lean mass and decrease in abdominal fat were positive predictors of P1NP .
-RESULTS	When IGF-1 was added to the model , it became the only predictor of P1NP .
-CONCLUSIONS	GH replacement in abdominally obese premenopausal women for 6 months increased bone turnover and bone marrow fat .
-CONCLUSIONS	Reductions in abdominal fat , and inflammation , and increases in IGF-1 , lean mass and vitamin D were associated with increased bone formation .
-CONCLUSIONS	The increase in bone marrow fat may reflect changes in energy demand from increased bone turnover .
-
-###25171741
-BACKGROUND	Worms may protect against allergy .
-BACKGROUND	Early-life worm exposure may be critical , but this has not been fully investigated .
-OBJECTIVE	To investigate whether worms in pregnancy and in early childhood are associated with childhood eczema incidence .
-METHODS	The Entebbe Mother and Baby Study , an anthelminthic treatment trial , enrolled pregnant women between 2003 and 2005 in Uganda .
-METHODS	Mothers were investigated for worms during pregnancy and children annually .
-METHODS	Eczema was doctor-diagnosed from birth to age five years .
-METHODS	A planned observational analysis was conducted within the trial cohort to investigate associations between worms and eczema .
-RESULTS	Data for 2345 live-born children were analysed .
-RESULTS	Hookworm was the most prevalent maternal worm ( 45 % ) .
-RESULTS	Childhood worms were less prevalent .
-RESULTS	Eczema incidence was 4.68 / 100 person-years .
-RESULTS	Maternal hookworm was associated with reduced eczema incidence [ adjusted hazard ratio ( 95 % confidence interval ) , p-value : 0.71 ( 0.51-0 .99 ) , 0.04 ] and modified effects of known risk factors for eczema : Dermatophagoides-specific IgE in children was positively associated with eczema incidence if the mother had no hookworm [ 2.72 ( 1.11-6 .63 ) , 0.03 ] , but not if the mother had hookworm [ 0.41 ( 0.10-1 .69 ) , 0.22 ] , interaction p-value = 0.03 .
-RESULTS	Similar interactions were seen for maternal history of eczema { [ 2.87 ( 1.31-6 .27 , 0.008 ) vs. [ 0.73 ( 0.23-2 .30 ) , 0.60 ] , interaction p-value = 0.05 } , female gender { [ 1.82 ( 1.22-2 .73 ) , 0.004 vs. [ 0.96 ( 0.60-1 .53 ) , 0.87 ] , interaction p-value = 0.04 } and allergen-specific IgE .
-RESULTS	Childhood Trichuris trichiura and hookworm were inversely associated with eczema .
-CONCLUSIONS	Maternal hookworm modifies effects of known risk factors for eczema .
-CONCLUSIONS	Mechanisms by which early-life worm exposures influence allergy need investigation .
-CONCLUSIONS	Worms or worm products , and intervention during pregnancy have potential for primary prevention of allergy .
-
-###25117817
-BACKGROUND	Epidermal growth factor receptor ( EGFR ) has been hypothesised to modulate the effectiveness of anti-HER2 therapy .
-BACKGROUND	We used a standardised , quantitative immunofluorescence assay and a novel EGFR antibody to evaluate the correlation between EGFR expression and clinical outcome in the North Central Cancer Treatment Group ( NCCTG ) N9831 trial .
-METHODS	Tissue microarrays were constructed that allowed analysis of 1365 patients randomly assigned to receive chemotherapy alone ( Arm A ) , sequential trastuzumab after chemotherapy ( Arm B ) and chemotherapy with concurrent trastuzumab ( Arm C ) .
-METHODS	Measurement of EGFR was performed using the EGFR antibody , D38B1 , on the fluorescence-based AQUA platform .
-METHODS	The result was validated using an independent retrospective metastatic breast cancer cohort ( n = 130 ) .
-RESULTS	Epidermal growth factor receptor assessed as a continuous ( logarithmic transformed ) variable shows an association with disease-free survival in Arm C ( P = 0.009 ) but not in Arm A or B. High EGFR expression was associated with worse outcome ( Hazard ratio ( HR ) = 2.15 ; 95 % CI 1.28-3 .60 , P = 0.004 ) .
-RESULTS	Validation in a Greek metastatic breast cancer cohort showed an HR associated with high EGFR expression of 1.92 ( P = 0.0073 ) .
-CONCLUSIONS	High expression of EGFR appears to be associated with decreased benefit from adjuvant concurrent trastuzumab .
-CONCLUSIONS	Since other treatment options exist for HER2-driven tumours , further validation of these data may select patients for alternative or additive therapy .
-
-###24655228
-OBJECTIVE	To evaluate an integrated telehealth intervention ( Integrated Telehealth Education and Activation of Mood ( I-TEAM ) ) to improve chronic illness ( congestive heart failure , chronic obstructive pulmonary disease ) and comorbid depression in the home healthcare setting .
-METHODS	Randomized controlled trial .
-METHODS	Hospital-affiliated home healthcare setting .
-METHODS	Medically frail older homebound individuals ( N = 102 ) .
-METHODS	The 3-month intervention consisted of integrated telehealth chronic illness and depression care , with a telehealth nurse conducting daily telemonitoring of symptoms , body weight , and medication use ; providing eight weekly sessions of problem-solving treatment for depression ; and providing for communication with participants ' primary care physicians , who also prescribed antidepressants .
-METHODS	Control participants were allocated to usual care with in-home nursing plus psychoeducation ( UC+P ) .
-METHODS	The two groups were compared at baseline and 3 and 6 months after baseline on clinical measures ( depression , health , problem-solving ) and 12 months after baseline on health utilization ( readmission , episodes of care , and emergency department ( ED ) visits ) .
-RESULTS	Depression scores were 50 % lower in the I-TEAM group than in the UC+P group at 3 and 6 months .
-RESULTS	Those who received the I-TEAM intervention significantly improved their problem-solving skills and self-efficacy in managing their medical condition .
-RESULTS	The I-TEAM group had significantly fewer ED visits ( P = .01 ) but did not have significantly fewer days in the hospital at 12 months after baseline .
-CONCLUSIONS	Integrated telehealth care for older adults with chronic illness and comorbid depression can reduce symptoms and postdischarge ED use in home health settings .
-
-###25585082
-OBJECTIVE	The aim of this study is to evaluate the effectiveness and complications associated with combined topical diltiazem cream and botulinum toxin A injection versus partial lateral internal sphincterotomy in chronic anal fissure .
-METHODS	This study is a parallel , randomized controlled trial ( using the block randomization method ) .
-METHODS	This study was performed at a university hospital in Iran .
-METHODS	Ninety-nine patients who had chronic anal fissures were included .
-METHODS	A total of 99 patients were randomly assigned to 2 groups ; the first group received combined topical diltiazem ointment ( for 6 weeks ) and botulinum toxin A injection ( once ) ( n = 49 ) , and the second group received partial lateral internal sphincterotomy ( n = 50 ) .
-METHODS	All the patients were followed up for 1 year .
-METHODS	The primary outcomes measured were the healing of the anal fissure and the development of incontinence as the major adverse event during the 1-year follow-up period .
-RESULTS	The overall healing rate was 65 % and 94 % in the botulinum toxin A-diltiazem and partial lateral internal sphincterotomy groups ( p < 0.001 ) .
-RESULTS	The patients in the partial lateral internal sphincterotomy group experienced significantly higher incontinence scores ( p = 0.04 ) according to the Cleveland Clinic Florida-Fecal Incontinence scoring system .
-RESULTS	In patients who had chronic anal fissure for 12 months , no statistical difference was observed in the healing rate between the botulinum toxin A-diltiazem and partial lateral internal sphincterotomy groups ( 100 % vs 100 % ) .
-RESULTS	However , in the patients with longer chronic fissures , the healing rate was significantly higher in the partial lateral internal sphincterotomy group ( 86 % [ 18/21 ] vs 23 % [ 5/21 ] , p < 0.001 ) .
-CONCLUSIONS	The 1-year follow-up period , subjective definitions of itching , and lack of anorectal manometry examinations and data regarding the effect of each treatment on anal sphincter pressure at rest and contraction are the key limitations of this study .
-CONCLUSIONS	Combined botulinum toxin A injection with a topical application of diltiazem could be as effective as partial lateral internal sphincterotomy in the treatment of chronic anal fissure in patients who have chronic anal fissure for 12 months .
-CONCLUSIONS	However , in chronic anal fissures of longer duration , partial lateral internal sphincterotomy is associated with a significantly higher cure rate .
-
-###25496482
-BACKGROUND	Although radiotherapy is a key component of curative-intent treatment for locally advanced , unresectable non-small cell lung cancer ( NSCLC ) , it can be associated with substantial pulmonary toxicity in some patients .
-BACKGROUND	Current radiotherapy planning techniques aim to minimize the radiation dose to the lungs , without accounting for regional variations in lung function .
-BACKGROUND	Many patients , particularly smokers , can have substantial regional differences in pulmonary ventilation patterns , and it has been hypothesized that preferential avoidance of functional lung during radiotherapy may reduce toxicity .
-BACKGROUND	Although several investigators have shown that functional lung can be identified using advanced imaging techniques and/or demonstrated the feasibility and theoretical advantages of avoiding functional lung during radiotherapy , to our knowledge this premise has never been tested via a prospective randomized clinical trial .
-METHODS	Eligible patients will have Stage III NSCLC with intent to receive concurrent chemoradiotherapy ( CRT ) .
-METHODS	Every patient will undergo a pre-treatment functional lung imaging study using hyperpolarized 3He MRI in order to identify the spatial distribution of normally-ventilated lung .
-METHODS	Before randomization , two clinically-approved radiotherapy plans will be devised for all patients on trial , termed standard and avoidance .
-METHODS	The standard plan will be designed without reference to the functional state of the lung , while the avoidance plan will be optimized such that dose to functional lung is as low as reasonably achievable .
-METHODS	Patients will then be randomized in a 1:1 ratio to receive either the standard or the avoidance plan , with both the physician and the patient blinded to the randomization results .
-METHODS	This study aims to accrue a total of 64 patients within two years .
-METHODS	The primary endpoint will be a pulmonary quality of life ( QOL ) assessment at 3 months post-treatment , measured using the functional assessment of cancer therapy-lung cancer subscale .
-METHODS	Secondary endpoints include : pulmonary QOL at other time-points , provider-reported toxicity , overall survival , progression-free survival , and quality-adjusted survival .
-CONCLUSIONS	This randomized , double-blind trial will comprehensively assess the impact of functional lung avoidance on pulmonary toxicity and quality of life in patients receiving concurrent CRT for locally advanced NSCLC .
-BACKGROUND	Clinicaltrials.gov identifier : NCT02002052 .
-
-###24532502
-OBJECTIVE	Unexpected requests for non-cardiac surgery requiring discontinuation of dual antiplatelet therapy ( DAPT ) frequently occur in daily clinical practice .
-OBJECTIVE	The objectives of this study were to evaluate prevalence , timing and clinical outcomes of such unexpected requests for non-cardiac surgery or other invasive procedures during the first year after drug-eluting stents ( DESs ) implantation .
-METHODS	We prospectively investigated the prevalence , timing and clinical outcomes of unexpected requests for non-cardiac surgery or other procedures during the first year after DESs implantation in 2117 patients .
-RESULTS	The prevalence of requested non-cardiac surgery or invasive procedures was 14.6 % in 310 requests and 12.3 % in 261 patients .
-RESULTS	Among 310 requests , those were proposed in 11.3 % < 1 month , 30.0 % between 1 and 3 months , 36.8 % between 4 and 6 months and 21.9 % between 7 and 12 months post-DES implantation .
-RESULTS	The rates of actual discontinuation of DAPT and non-cardiac surgery or procedure finally performed were 35.8 % ( 111 of 310 requests ) and 53.2 % ( 165 of 310 requests ) , respectively .
-RESULTS	On multivariate regression analysis , the most significant determinants for actual discontinuation of DAPT were Endeavor zotarolimus-eluting stent implantation with 3-month DAPT ( OR = 5.54 , 95 % CI 2.95-10 .44 , p < 0.001 ) and timing of request ( OR = 2.84 , 95 % CI 1.97-4 .11 , p < 0.001 ) .
-RESULTS	There were no patients with any death , myocardial infarction , or stent thrombosis related with actual discontinuation of DAPT .
-CONCLUSIONS	Those unexpected requests with premature discontinuation of DAPT were relatively common and continuously proposed during the first year following DES implantation .
-CONCLUSIONS	No death , myocardial infarction or stent thrombosis occurred in patients with actual discontinuation of DAPT .
-
-###24635773
-BACKGROUND	In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock , mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy ( EGDT ) , in which intravenous fluids , vasopressors , inotropes , and blood transfusions were adjusted to reach central hemodynamic targets , than among those receiving usual care .
-BACKGROUND	We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary .
-METHODS	In 31 emergency departments in the United States , we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation : protocol-based EGDT ; protocol-based standard therapy that did not require the placement of a central venous catheter , administration of inotropes , or blood transfusions ; or usual care .
-METHODS	The primary end point was 60-day in-hospital mortality .
-METHODS	We tested sequentially whether protocol-based care ( EGDT and standard-therapy groups combined ) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy .
-METHODS	Secondary outcomes included longer-term mortality and the need for organ support .
-RESULTS	We enrolled 1341 patients , of whom 439 were randomly assigned to protocol-based EGDT , 446 to protocol-based standard therapy , and 456 to usual care .
-RESULTS	Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids , vasopressors , inotropes , and blood transfusions .
-RESULTS	By 60 days , there were 92 deaths in the protocol-based EGDT group ( 21.0 % ) , 81 in the protocol-based standard-therapy group ( 18.2 % ) , and 86 in the usual-care group ( 18.9 % ) ( relative risk with protocol-based therapy vs. usual care , 1.04 ; 95 % confidence interval [ CI ] , 0.82 to 1.31 ; P = 0.83 ; relative risk with protocol-based EGDT vs. protocol-based standard therapy , 1.15 ; 95 % CI , 0.88 to 1.51 ; P = 0.31 ) .
-RESULTS	There were no significant differences in 90-day mortality , 1-year mortality , or the need for organ support .
-CONCLUSIONS	In a multicenter trial conducted in the tertiary care setting , protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes .
-CONCLUSIONS	( Funded by the National Institute of General Medical Sciences ; ProCESS ClinicalTrials.gov number , NCT00510835 . )
-
-###24484545
-BACKGROUND	A limitation of traditional outcome studies from behavioral interventions is the lack of attention given to evaluating the influence of moderating variables .
-BACKGROUND	This study examined possible moderation effect of baseline activity levels on physical activity change as a result of the Ready for Recess intervention .
-METHODS	Ready for Recess ( August 2009-September 2010 ) was a controlled trial with twelve schools randomly assigned to one of four conditions : control group , staff supervision , equipment availability , and the combination of staff supervision and equipment availability .
-METHODS	A total of 393 children ( 181 boys and 212 girls ) from grades 3 through 6 ( 8-11years old ) were asked to wear an Actigraph monitor during school time on 4-5days of the week .
-METHODS	Assessments were conducted at baseline ( before intervention ) and post intervention ( after intervention ) .
-RESULTS	Initial MVPA moderated the effect of Staff supervision ( = -0.47 % ; p < .05 ) , but not Equipment alone and Staff + Equipment ( p > .05 ) .
-RESULTS	Participants in the Staff condition that were 1 standard deviation ( SD ) below the mean for baseline MVPA ( classified as `` low active '' ) had lower MVPA levels at post-intervention when compared with their low active peers in the control condition ( Mean diff = -10.82.9 % ; p = .005 ) .
-RESULTS	High active individuals ( +1 SD above the mean ) in the Equipment treatment also had lower MVPA values at post-intervention when compared with their highly active peers in the control group ( Mean diff = -9.52.9 % ; p = .009 ) .
-CONCLUSIONS	These results indicate that changes in MVPA levels at post-intervention were reduced in highly active participants when recess staff supervision was provided .
-CONCLUSIONS	In this study , initial MVPA moderated the effect of Staff supervision on children 's MVPA after 6months of intervention .
-CONCLUSIONS	Staff training should include how to work with inactive youth but also how to assure that active children remain active .
-
-###25038015
-BACKGROUND	The prone position ( PP ) and decubitus position ( DP ) have both been used for thoracoscopic esophagectomy .
-BACKGROUND	However , which of these positions is ergonomically better for the operating surgeon is unknown .
-BACKGROUND	In this randomized controlled trial ( NCT01144325 ) , we aimed to assess the surgeon 's physical and mental stress in operating on patients in the PP compared with that in the DP .
-METHODS	From October 2012 to June 2013 , 67 consecutive patients who underwent a three-stage minimally invasive esophagectomy were randomly assigned to the DP or the PP during the thoracic stage .
-METHODS	The same senior surgeon performed all operations .
-METHODS	Objectively , the surgeon 's spontaneous eye blink rate was recorded during thoracoscopic esophagectomy .
-METHODS	Subjectively , the physician 's musculoskeletal symptoms were rated on a scale ranging from 1 ( uninfluenced ) to 10 ( maximum fatigue ) .
-METHODS	Clinical characteristics , including patient demographics and operative features of the two patient groups , were statistically compared .
-RESULTS	There were 35 patients in the PP group and 32 in the DP group .
-RESULTS	The two groups were comparable in patient demographics .
-RESULTS	The thoracic stage of the operation was longer in the DP group than in the PP group ( 87 24 minutes vs 68 22 minutes , p < 0.001 ) , and the volume of blood loss was higher ( 89 18 mL vs 67 16 mL , p < 0.001 ) .
-RESULTS	The surgeon 's eye blink rate at the end of thoracic stage decreased more from baseline in the DP group than in the PP group ( 3.0 1.4 blinks/min vs 1.2 0.9 blinks/min , p < 0.001 ) , and the surgeon 's symptom scale score was higher after operation with the patient in the DP than in the PP ( 6.29 1.54 vs 3.13 2.82 , p < 0.001 ) .
-RESULTS	No conversion to open thoracotomy was recorded in either group .
-CONCLUSIONS	Thoracoscopic esophagectomy in the PP provided less workload and better ergonomic results than the DP .
-CONCLUSIONS	Further study based on a larger number of patients is required to confirm these findings .
-
-###24422892
-BACKGROUND	Improvement in treatment for patients with recurrent ovarian cancer is needed .
-BACKGROUND	Standard therapy in patients with platinum-sensitive recurrent ovarian cancer consists of platinum-based chemotherapy .
-BACKGROUND	Median overall survival is reported between 18 and 35 months .
-BACKGROUND	Currently , the role of surgery in recurrent ovarian cancer is not clear .
-BACKGROUND	In selective patients a survival benefit up to 62 months is reported for patients undergoing complete secondary cytoreductive surgery .
-BACKGROUND	Whether cytoreductive surgery in recurrent platinum-sensitive ovarian cancer is beneficial remains questionable due to the lack of level I-II evidence .
-METHODS	Multicentre randomized controlled trial , including all nine gynecologic oncologic centres in the Netherlands and their affiliated hospitals .
-METHODS	Eligible patients are women , with first recurrence of FIGO stage Ic-IV platinum-sensitive epithelial ovarian cancer , primary peritoneal cancer or fallopian tube cancer , who meet the inclusion criteria .
-METHODS	Participants are randomized between the standard treatment consisting of at least six cycles of intravenous platinum based chemotherapy and the experimental treatment which consists of secondary cytoreductive surgery followed by at least six cycles of intravenous platinum based chemotherapy .
-METHODS	Primary outcome measure is progression free survival .
-METHODS	In total 230 patients will be randomized .
-METHODS	Data will be analysed according to intention to treat .
-CONCLUSIONS	Where the role of cytoreductive surgery is widely accepted in the initial treatment of ovarian cancer , its value in recurrent platinum-sensitive epithelial ovarian cancer has not been established so far .
-CONCLUSIONS	A better understanding of the benefits and patients selection criteria for secondary cytoreductive surgery has to be obtained .
-CONCLUSIONS	Therefore the 4th ovarian cancer consensus conference in 2010 stated that randomized controlled phase 3 trials evaluating the role of surgery in platinum-sensitive recurrent epithelial ovarian cancer are urgently needed .
-CONCLUSIONS	We present a recently started multicentre randomized controlled trial that will investigate the role of secondary cytoreductive surgery followed by chemotherapy will improve progression free survival in selected patients with first recurrence of platinum-sensitive epithelial ovarian cancer .
-
-###24365774
-BACKGROUND	Heart failure with preserved ejection fraction ( HFpEF ) is a heterogeneous syndrome associated with multiple pathophysiologic abnormalities , including left ventricular ( LV ) diastolic dysfunction , longitudinal LV systolic dysfunction , abnormal ventricular-arterial coupling , pulmonary hypertension , and right ventricular ( RV ) remodeling/dysfunction .
-BACKGROUND	However , the relative prognostic significance of each of these pathophysiologic abnormalities in HFpEF is unknown .
-RESULTS	We prospectively studied 419 patients with HFpEF using echocardiography and sphygmomanometry to assess HFpEF pathophysiologic markers .
-RESULTS	Cox proportional hazards analyses were used to determine the associations between pathophysiologic markers and outcomes .
-RESULTS	Mean age was 6512 years ; 62 % were women ; 39 % were black ; comorbidities were common ; and study participants met published criteria for HFpEF .
-RESULTS	RV abnormalities were frequent : 28 % had abnormal tricuspid annular plane systolic excursion , 15 % had reduced RV fractional area change , and 34 % had RV hypertrophy .
-RESULTS	During a median follow-up time of 18 months , 102 ( 24 % ) were hospitalized for HF and 175 ( 42 % ) experienced the composite end point of cardiovascular hospitalization or death .
-RESULTS	Decreased LV compliance , measured as reduced LV end-diastolic volume at an idealized LV end-diastolic pressure of 20 mm Hg ( EDV20 ) , and RV remodeling , as indicated by increased RV wall thickness , were the 2 pathophysiologic markers most predictive of worse outcomes : adjusted hazard ratio per 1 SD decrease in EDV20 = 1.39 ( 95 % confidence interval [ CI ] , 1.10-1 .75 ; P = 0.006 ) , and hazard ratio per 1 SD increase in RV wall thickness = 1.37 ( 95 % CI , 1.16-1 .61 ; P < 0.001 ) .
-RESULTS	These associations persisted after additional adjustment for markers of HF severity .
-RESULTS	By contrast , markers of LV relaxation , longitudinal LV systolic dysfunction , and ventricular-arterial coupling were not significantly associated with adverse outcomes .
-CONCLUSIONS	In patients with HFpEF , reduced LV compliance and RV remodeling are the strongest pathophysiologic predictors of adverse outcomes .
-
-###24454949
-BACKGROUND	We examined the impact of a 24 hour complete fast ( vs. fed state ) on two measures of food reward : 1 ) ` wanting ' , as measured by response to food images and by the relative-reinforcing value of food ( RRV ) , and 2 ) ` liking ' , as measured by response to food images and the hedonic evaluation of foods consumed .
-METHODS	Utilizing a randomized crossover design , 15 subjects ( 9 male ; 6 female ) aged 28.64.5 yrs with body mass index 25.31.4 kg/m ( 2 ) were randomized and counterbalanced to normal feeding ( FED ) and 24-hour fast ( FASTED ) conditions .
-METHODS	Trait characteristics were measured with the Three Factor Eating Questionnaire .
-METHODS	Two computer tasks measured food reward : 1 ) RRV progressive ratio task , 2 ) explicit ` liking ' and ` wanting ' ( Leeds Food Preference Questionnaire , LFPQ ) .
-METHODS	Also measured were ad libitum energy intake ( EI ; buffet ) and food ` liking ' ( visual analogue scale ) of personalized stimuli .
-RESULTS	There were no significant anthropometric changes between conditions .
-RESULTS	Appetite scores , hedonic ratings of ` liking ' , and ad libitum EI all significantly increased under the FASTED condition ( p < 0.05 ) .
-RESULTS	Under the FASTED condition there were significant increases in the RRV of snack foods ; similarly , explicit ` wanting ' and ` liking ' significantly increased for all food categories .
-RESULTS	` Liking ' of sweet foods remained high across-meals under FASTED , but savory foods decreased in hedonic saliency .
-CONCLUSIONS	Relative to a fed state , we observed an increase in hedonic ratings of food , the rewarding value of food , and food intake after a 24 hr fast .
-CONCLUSIONS	Alliesthesia to food and food cues is suggested by heightened hedonic ratings under the FASTED condition relative to FED .
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-###24276777
-OBJECTIVE	To determine whether a nurse navigator intervention improves quality of life and patient experience with care for people recently given a diagnosis of breast , colorectal , or lung cancer .
-METHODS	Adults with recently diagnosed primary breast , colorectal , or lung cancer ( n = 251 ) received either enhanced usual care ( n = 118 ) or nurse navigator support for 4 months ( n = 133 ) in a two-group cluster randomized , controlled trial with primary care physicians as the units of randomization .
-METHODS	Patient-reported measures included the Functional Assessment of Cancer Therapy-General ( FACT-G ) Quality of Life scale , three subscales of the Patient Assessment of Chronic Illness Care ( PACIC ) , and selected subscales from a cancer adaptation of the Picker Institute 's patient experience survey .
-METHODS	Self-report measures were collected at baseline , 4 months , and 12 months .
-METHODS	Automated administrative data were used to assess time to treatment and total health care costs .
-RESULTS	There were no significant differences between groups in FACT-G scores .
-RESULTS	Nurse navigator patients reported significantly higher scores on the PACIC and reported significantly fewer problems with care , especially psychosocial care , care coordination , and information , as measured by the Picker instrument .
-RESULTS	Cumulative costs after diagnosis did not differ significantly between groups , but lung cancer costs were $ 6,852 less among nurse navigator patients .
-CONCLUSIONS	Compared with enhanced usual care , nurse navigator support for patients with cancer early in their course improves patient experience and reduces problems in care , but did not differentially affect quality of life .
-
-###25204642
-BACKGROUND	Epidemiological and experimental studies suggest that exposure to ultrafine particles ( UFP ) might aggravate the allergic inflammation of the lung in asthmatics .
-METHODS	We exposed 12 allergic asthmatics in two subgroups in a double-blinded randomized cross-over design , first to freshly generated ultrafine carbon particles ( 64 g/m ; 6.10.4 10 particles/cm for 2 h ) and then to filtered air or vice versa with a 28-day recovery period in-between .
-METHODS	Eighteen hours after each exposure , grass pollen was instilled into a lung lobe via bronchoscopy .
-METHODS	Another 24 hours later , inflammatory cells were collected by means of bronchoalveolar lavage ( BAL ) .
-BACKGROUND	NCT00527462 ) RESULTS : For the entire study group , inhalation of UFP by itself had no significant effect on the allergen induced inflammatory response measured with total cell count as compared to exposure with filtered air ( p = 0.188 ) .
-BACKGROUND	However , the subgroup of subjects , which inhaled UFP during the first exposure , exhibited a significant increase in total BAL cells ( p = 0.021 ) , eosinophils ( p = 0.031 ) and monocytes ( p = 0.013 ) after filtered air exposure and subsequent allergen challenge 28 days later .
-BACKGROUND	Additionally , the potential of BAL cells to generate oxidant radicals was significantly elevated at that time point .
-BACKGROUND	The subgroup that was exposed first to filtered air and 28 days later to UFP did not reveal differences between sessions .
-CONCLUSIONS	Our data demonstrate that pre-allergen exposure to UFP had no acute effect on the allergic inflammation .
-CONCLUSIONS	However , the subgroup analysis lead to the speculation that inhaled UFP particles might have a long-term effect on the inflammatory course in asthmatic patients .
-CONCLUSIONS	This should be reconfirmed in further studies with an appropriate study design and sufficient number of subjects .
-
-###24237751
-OBJECTIVE	Zinc plays a role in skin health , and preliminary data have shown its beneficial effects for melasma .
-OBJECTIVE	We compared the effect of topical zinc with that of hydroquinone as the standard treatment on severity of melasma .
-METHODS	Ninety-three women with melasma were randomized to receive zinc sulfate 10 % or hydroquinone 4 % solutions once daily for 2months .
-METHODS	They were followed for an additional 3months while using sunscreen .
-METHODS	The severity of melasma was assessed at baseline and at 2 and 5months using the Melasma Area and Severity Index ( MASI ) .
-RESULTS	Eighty-two patients completed the study .
-RESULTS	The MASI score fell significantly in both groups , but a greater decrease was seen in those who received hydroquinone ( 43.515.5 % vs 18.620.8 % , p < .001 ) .
-RESULTS	Postinflammatory pigmentation occurred in 5.2 % of the zinc group and irritation in 30.9 % of the hydroquinone group .
-CONCLUSIONS	Topical zinc therapy is not highly effective in reducing the severity of melasma , but further trials are needed to determine whether adding zinc to current topical treatments could improve treatment response .
-
-###24310444
-OBJECTIVE	For the premature infant , extrauterine life is a pathological condition , which greatly amplifies the challenges to the brain in establishing functional oromotor behaviors .
-OBJECTIVE	The extent to which suck can be entrained using a synthetically patterned orocutaneous input to promote its development in preterm infants who manifest chronic lung disease ( CLD ) is unknown .
-OBJECTIVE	The objective of this study was to evaluate the effects of a frequency-modulated ( FM ) orocutaneous pulse train delivered through a pneumatically charged pacifier capable of enhancing non-nutritive suck ( NNS ) activity in tube-fed premature infants .
-METHODS	A randomized trial to evaluate the efficacy of pneumatic orocutaneous stimulation 3 per day on NNS development and length of stay ( LOS ) in the neonatal intensive care unit among 160 newborn infants distributed among three sub-populations , including healthy preterm infants , respiratory distress syndrome ( RDS ) and CLD .
-METHODS	Study infants received a regimen of orocutaneous pulse trains through a PULSED pressurized silicone pacifier or a SHAM control ( blind pacifier ) during gavage feeds for up to 10 days .
-RESULTS	Mixed modeling , adjusted for the infant 's gender , gestational age , postmenstrual age and birth weight , was used to handle interdependency among repeated measures within subjects .
-RESULTS	A significant main effect for stimulation mode ( SHAM pacifier vs PULSED orosensory ) was found among preterm infants for NNS bursts per min ( P = 0.003 ) , NNS events per min ( P = 0.033 ) and for total oral compressions per min ( NNS + nonNNS ) ( P = 0.016 ) .
-RESULTS	Pairwise comparison of adjusted means using Bonferroni adjustment indicated RDS and CLD infants showed the most significant gains on these NNS performance indices .
-RESULTS	CLD infants in the treatment group showed significantly shorter LOS by an average of 2.5 days .
-CONCLUSIONS	FM PULSED orocutaneous pulse train stimuli delivered through a silicone pacifier are effective in facilitating NNS burst development in tube-fed RDS and CLD preterm infants , with an added benefit of reduced LOS for CLD infants .
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-###25411294
-BACKGROUND	Prenatal calcium and iron supplements are recommended in settings of low dietary calcium intake and high prevalence of anemia .
-BACKGROUND	However , calcium administration may inhibit iron absorption .
-BACKGROUND	To overcome calcium-iron interactions , we developed a multi-micronutrient powder containing iron ( 60 mg ) , folic acid ( 400 g ) , and calcium carbonate granules microencapsulated with a pH-sensitive enteric coating to delay intestinal release .
-OBJECTIVE	We aimed to establish in vivo evidence that enteric-coated ( EC ) calcium is bioavailable in pregnant women and to explore the dose-responsiveness of fractional calcium absorption ( FCA ) in pregnancy .
-METHODS	This was a randomized crossover trial in pregnant women ( 26-28 wk of gestation ) in Dhaka , Bangladesh .
-METHODS	Participants were allocated to 1 of 3 dose groups ( 500 , 1000 , or 1500 mg elemental Ca ) .
-METHODS	FCA was estimated in random order for EC and non-EC ( control ) granules by a dual-stable-isotope method ( ( 44 ) Ca-labeled granules and intravenous ( 42 ) Ca ) on the basis of the relative recovery of ( 44 ) Ca compared with ( 42 ) Ca in urine over 48 h.
-RESULTS	Forty-nine participants with FCA for both EC and non-EC granules were included in the primary analyses .
-RESULTS	FCA geometric means were as follows : 21.8 % ( 500 mg ) , 9.2 % ( 1000 mg ) , and 11.7 % ( 1500 mg ) for non-EC granules compared with 3.3 % ( 500 mg ) , 1.2 % ( 1000 mg ) , and 2.1 % for EC granules .
-RESULTS	Cumulative 48-h FCA of EC calcium was 85 % lower ( P < 0.001 ) than that of non-EC calcium , after adjustment for dose .
-RESULTS	In comparison to 500 mg , the FCA for the 1000-mg dose was 61 % lower ( P < 0.001 ) and was 42 % lower ( P = 0.002 ) for the 1500-mg dose , after adjustment for formulation .
-CONCLUSIONS	A pH-sensitive enteric coating substantially reduced calcium absorption from a prenatal multi-micronutrient powder .
-CONCLUSIONS	In its current formulation , this novel supplement is not suitable for clinical use .
-CONCLUSIONS	FCA was highly dose-dependent , such that doses of 1000 and 1500 mg delivered only negligibly more bioavailable calcium than the 500-mg dose .
-CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01678079 .
-
-###26255475
-OBJECTIVE	To compare clinical effect of T-shaped locking internal fixation and external fixation in treating dorsal Barton 's fracture , and investigate selective strategy of internal fixation .
-METHODS	From January 2008 to January 2013 , 100 patients with dorsal Barton 's fracture were randomly divided into two groups .
-METHODS	In treatment group , there were 30 males and 20 females with an average age of ( 33.83.6 ) years old ; 30 cases were type B , 20 cases were type C ; and treated with T-shaped locking internal fixation .
-METHODS	In control group , there were 32 male and 18 females with an average age of ( 32.93.4 ) years old ; 29 cases were type B , 21 cases were type C ; and treated with external fixation .
-METHODS	Volar tilt , ulnar deviation and radial height at 3 months after operation were detected and compared between two groups .
-METHODS	Mechara functional evaluation were used to evaluate postoperative clinical effects .
-METHODS	Clinical cure time , postoperative complications , joint mobility and function score were recorded and compared between two groups .
-RESULTS	In treatment group , volar tilt was ( 11.92.7 ) , ulnar deviation was ( 20.8 + 2.9 ) , and radial height was ( 10.91.8 ) mm ; while volar tilt was ( 9.11.6 ) , ulnar deviation was ( 17.12.9 ) , and radial height was ( 8.11.5 ) mm in control group .
-RESULTS	Treatment group was better than control group in volar tilt , ulnar deviation and radial height .
-RESULTS	Clinical cure time in treatment group was ( 12.02.3 ) weeks , shorter than control group ( 18.04.1 ) weeks .
-RESULTS	The incidence of complications in treatment group was lower than control group .
-RESULTS	According to Mehara functional evaluation ,20 cases got excellent results , 25 good , 3 moderate and 2 poor in treatment group ; 16 cases got excellent results , 14 good , 10 moderate and 10 poor in control group .
-RESULTS	Treatment group was better than control group in clinical effects .
-CONCLUSIONS	T-shaped locking internal fixation with postoperative functional exercise for the treatment of dorsal Barton 's fracture fits for biomechanics demands , and has advantages of stable fixation , rapid recovery , less complications and good functional recovery , it has better clinical effects .
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-###25409738
-BACKGROUND	Gastrointestinal bleeding is a common emergency that causes substantial mortality worldwide .
-BACKGROUND	Acute upper and lower gastrointestinal bleeding accounts for about 75,000 hospital admissions each year in the UK and causes the death of about 10 % of these patients .
-BACKGROUND	Tranexamic acid has been shown to reduce the need for blood transfusion in surgical patients and to reduce mortality in bleeding trauma patients , with no apparent increase in thromboembolic events .
-BACKGROUND	A systematic review of clinical trials of upper gastrointestinal bleeding shows a reduction in the risk of death with tranexamic acid but the quality of the trials was poor and the estimates are imprecise .
-BACKGROUND	The trials were also too small to assess the effect of tranexamic acid on thromboembolic events .
-METHODS	HALT-IT is a pragmatic , randomised , double-blind , placebo-controlled trial which will determine the effect of tranexamic acid on mortality , morbidity ( re-bleeding , non-fatal vascular events ) , blood transfusion , surgical intervention , and health status in patients with acute gastrointestinal bleeding .
-METHODS	Eight thousand adult patients who fulfil the eligibility criteria will be randomised to receive tranexamic acid or placebo .
-METHODS	Adults with significant acute upper or lower gastrointestinal bleeding can be included if the responsible doctor is substantially uncertain as to whether or not to use tranexamic acid in that particular patient .
-METHODS	Trial treatment consists of a loading dose of tranexamic acid ( 1 g by intravenous injection ) or placebo ( sodium chloride 0.9 % ) given as soon as possible after randomisation , followed by an intravenous infusion of 3 g tranexamic acid or placebo ( sodium chloride 0.9 % ) over 24 hours .
-METHODS	The main analyses will compare those allocated tranexamic acid with those allocated placebo , on an intention-to-treat basis .
-METHODS	Results will be presented as effect estimates with a measure of precision ( 95 % confidence intervals ) .
-METHODS	Subgroup analyses for the primary outcome will be based on time to treatment , source of bleeding ( upper versus lower ) , suspected variceal bleeding and severity of bleeding .
-METHODS	A study with 8,000 patients will have over 90 % power to detect a 25 % reduction in mortality from 10 % to 7.5 % .
-BACKGROUND	Current Controlled Trials ISRCTN11225767 ( registration date : 3 July 2012 ) ; Clinicaltrials.gov NCT01658124 ( registration date : 26 July 2012 ) .
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-###24766747
-OBJECTIVE	We aimed to explore the association between vitamin D levels and the severity , mortality and microbiological etiology of community-acquired pneumonia .
-METHODS	Vitamin D levels ( both , the reservoir form 25-OH and the activated form 1,25-OH2 ) of 300 randomly selected patients with community-acquired pneumonia due to pre-specified pathogens included in the German competence network ( CAPNETZ ) study were measured .
-METHODS	Prior to statistical analysis , values of 25-OH and 1,25-OH2 were power-transformed to achieve parametric distribution .
-METHODS	All further analyses were performed with seasonally and age adjusted values .
-RESULTS	There was only a modest ( Spearman Coefficient 0.38 ) positive correlation between 25-OH and 1,25-OH2 .
-RESULTS	For 1,25-OH2 but not 25-OH , the general linear model revealed a significant inverse correlation between serum concentration and CURB score ( p = 0.011 ) .
-RESULTS	Liver and respiratory co-morbidity were associated with significantly lower 25-OH values and renal co-morbidity with significantly lower 1,25-OH2 values .
-RESULTS	No significant differences of 1,25-OH2 or 25-OH between different pathogens ( influenza virus , Legionella spp. , Streptococcus pneumoniae ) were detected .
-CONCLUSIONS	For 1,25-OH2 , we found a significant and independent ( controlled for age , season and pathogen ) negative correlation to pneumonia severity .
-CONCLUSIONS	Therefore , supplementation of non-activated vitamin D to protect from pneumonia may be non-sufficient in patients that have a decreased capacity to hydroxylate 25-OH to 1,25-OH2 .
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-###24697580
-OBJECTIVE	To determine the association between interleukin-6 ( IL-6 ) , IL-6 soluble receptor ( sR ) , and soluble tumor necrosis factor receptor-1 ( sTNF-R1 ) and cognitive status in the oldest-old women .
-METHODS	Twenty-year longitudinal cohort study .
-METHODS	Four clinical sites in the United States .
-METHODS	Women from the Study of Osteoporotic Fractures ( N = 905 ; mean age 88.3 2.8 at cognitive status adjudication ) .
-METHODS	At Year 20 , cognitive status was adjudicated as normal , mild cognitive impairment ( MCI ) , or dementia .
-METHODS	Inflammatory markers were measured from blood serum at Years 10 and 16 in a random sample of women .
-RESULTS	Over 10 years , 199 ( 22.0 % ) women developed MCI and 145 ( 16.0 % ) dementia .
-RESULTS	There were no significant associations between IL-6 or sTNF-R1 and cognitive status .
-RESULTS	High IL-6-sR ( 37,401.36 pg/mL , highest tertile ) at Year 16 was significantly associated with lower risk of dementia ( odds ratio ( OR ) = 0.54 , 95 % confidence interval ( CI ) = 0.30-0 .97 ) than in women with lower levels ( < 37,401.36 pg/mL , lower two tertiles ) .
-RESULTS	Women with high IL-6-sR at both time points ( OR = 0.39 , 95 % CI = 0.17-0 .89 ) or who transitioned to a high level ( OR = 0.35 , 95 % CI = 0.14-0 .88 ) had a lower risk of dementia .
-CONCLUSIONS	In this cohort of white , high-functioning oldest-old women , a consistently high or an increasing level of IL-6-sR was associated with lower risk of dementia .
-CONCLUSIONS	Compared with other studies of younger-old adults , this suggests that the effect of inflammation on dementia may differ in younger-old and the oldest-old individuals .
-CONCLUSIONS	Understanding these differences will be crucial in interpreting results from ongoing clinical trials and in targeting therapeutic strategies to the oldest-old individuals .
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-###24354968
-BACKGROUND	Prisoners have extremely high rates of smoking with rates 3-4 times higher than the general community .
-BACKGROUND	Many prisoners have used heroin .
-BACKGROUND	The aims of this study were to investigate the impact of heroin use on smoking cessation and the social determinants of health among prisoners .
-METHODS	Secondary analysis of data from a randomised controlled trial of a multi-component smoking cessation intervention involving 425 Australian male prisoners .
-METHODS	Inmates who , prior to imprisonment , used heroin regularly were compared to those who did not use heroin regularly .
-METHODS	Self-reported smoking status was validated at baseline and each follow-up by measuring carbon monoxide levels .
-METHODS	Readings exceeding 10 ppm were defined as indicating current smoking .
-RESULTS	Over half ( 56.5 % ) of the participants had ever used heroin while 37.7 % regularly ( daily or almost daily ) used heroin in the year prior to entering prison .
-RESULTS	Prisoners who regularly used heroin had significantly worse social determinants of health and smoking behaviours , including lower educational attainment , more frequent incarceration and earlier initiation into smoking .
-RESULTS	Prisoners who regularly used heroin also used and injected other drugs significantly more frequently .
-RESULTS	At 12-month follow-up , the smoking cessation of prisoners who had regularly used heroin was also significantly lower than prisoners who did not regularly use heroin , a finding confirmed by logistic regression .
-CONCLUSIONS	Regular heroin use prior to imprisonment is an important risk factor for unsuccessful attempts to quit smoking among prisoners and is also associated with worse social determinants of health , higher drug use , and worse smoking behaviours .
-CONCLUSIONS	More effective and earlier smoking cessation interventions are required for particularly disadvantaged groups .
-BACKGROUND	This trial is registered with the Australian New Zealand Clinical Trials Registry 12606000229572 .
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-###24769270
-BACKGROUND	Telemonitoring has been advocated as a way of decreasing costs and improving outcomes , but no study has looked at true Medicare payments and 30-day readmission rates in a randomized group of well treated patients .
-OBJECTIVE	The aim of this work was to analyze Medicare claims data to identify effects of home telemonitoring on medical costs , 30-day rehospitalization , mortality , and health-related quality of life .
-METHODS	A total of 204 subjects were randomized to usual-care and monitored groups and evaluated with the SF-36 and Minnesota Living With Heart Failure Questionnaire ( MLHF ) .
-METHODS	Hospitalizations , Medicare payments , and mortality were also assessed .
-METHODS	Monitored subjects transmitted weight , blood pressure , and heart rate , which were monitored by an experienced heart failure nurse practitioner .
-RESULTS	Subjects were followed for 802430days ; 75 subjects in the usual-care group ( 316 hospitalizations ) and 81 in the monitored group ( 327 hospitalizations ) were hospitalized at least once ( P = .51 ) .
-RESULTS	There were no differences in Medicare payments for inpatient or emergency department visits , and length of stay was not different between groups .
-RESULTS	There was no difference in 30-day readmissions ( P = .627 ) or mortality ( P = .575 ) .
-RESULTS	Scores for SF-36 and MLHF improved ( P < .001 ) over time , but there were no differences between groups .
-RESULTS	The percentage of patients readmitted within 30days was lower with telemonitoring for the 1st year , but this did not persist .
-CONCLUSIONS	Telemonitoring did not result in lower total costs , decreased hospitalizations , improved symptoms , or improved mortality .
-CONCLUSIONS	A decrease in 30-day readmission rates for the 1st year did not result in decreased total cost or better outcomes .
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-###24998572
-BACKGROUND	We evaluated whether providing health risk appraisal for Koreans ( KHRA ) in terms of ` health age ' during smoking cessation program would effectively help smokers quit smoking or not .
-METHODS	A total of 332 male smokers aged between 30-65 years old , registered for a smoking cessation program in a public health center in a city , were recruited and underwent a baseline survey from January 2010 to February 2011 .
-METHODS	They were then prospectively randomized to a conventional counseling group ( n = 165 ) or a KHRA group ( n = 167 ) , and received conventional counseling or KHRA-based counseling for six months .
-METHODS	Abstinence rates were identified through carbon monoxide measurement ( at the 4th and 24th weeks ) or urinary cotinine level ( at the 12th week ) .
-RESULTS	The abstinence rate confirmed by exhaled carbon monoxide was significantly higher in the KHRA group ( 61.1 % ) than the control group ( 49.1 % ) at the 4th week ( absolute difference 12.0 % , 95 % CI : 1.4 % -22.6 % ) .
-RESULTS	However , there was no difference in abstinence rates between the two groups at the 12th and 24th weeks .
-RESULTS	The predicting factors of 24 week 's smoking cessation success were age , older than 50 years old ( OR 2.02 , 95 % CI : 1.16-3 .52 ) , lower Fagerstrom Test for Nicotine Dependence score less than 4 ( OR 1.84 , 95 % CI : 1.03-3 .29 ) , and higher Self Efficacy/Temptation score ( OR 1.79 , 95 % CI : 1.05-3 .06 ) .
-CONCLUSIONS	Smoking cessation counseling with KHRA could be effective compared to conventional counseling in the short period of smoking cessation .
-CONCLUSIONS	Further study is needed to evaluate the long-term efficacy of KHRA in tobacco dependence treatment and to establish the indication and target population of this tool .
-
-###24508362
-BACKGROUND	The clinical relevance of evaluating right ventricular ( RV ) myocardial deformation in congenital heart disease is increasingly recognized .
-BACKGROUND	The aim of this study was to explore , using three-dimensional ( 3D ) speckle-tracking echocardiography , RV mechanics in terms of 3D global area strain and mechanical dyssynchrony in adults with repaired tetralogy of Fallot .
-METHODS	Twenty patients ( 12 men ) aged 24.7 8.6 years and 22 age-matched controls ( 11 men ) were studied .
-METHODS	Global RV peak area strain and area strain-derived systolic dyssynchrony index ( SDI ) were determined using 3D speckle-tracking echocardiography .
-METHODS	RV end-diastolic volume and end-systolic volume , ejection fraction ( EF ) , and pulmonary regurgitation fraction were measured in patients using cardiac magnetic resonance .
-RESULTS	Coefficients of variation for intraobserver and interobserver measurements of RV global area strain were 6.1 % and 7.9 % , respectively , and those for SDI were 7.6 % and 10.1 % , respectively .
-RESULTS	Compared with controls , patients had significantly lower global area strain ( P = .005 ) and greater SDI ( P = .008 ) .
-RESULTS	The prevalence of RV mechanical dyssynchrony ( SDI > control mean + 2 SDs ) in patients was 30 % .
-RESULTS	In patients , global area strain correlated inversely with SDI ( r = -0.42 , P = .04 ) , RV end-diastolic volume ( r = -0.48 , P = .032 ) , and RV end-systolic volume ( r = -0.48 , P = .031 ) and positively with EF ( r = -0.51 , P = .02 ) , while RV SDI correlated positively with RV end-systolic volume ( r = 0.55 , P = .012 ) , pulmonary regurgitation fraction ( r = 0.54 , P = .031 ) , and QRS duration ( r = 0.51 , P = .022 ) and negatively with RV EF ( r = -0.62 , P = .004 ) .
-RESULTS	Multivariate analysis showed that RV EF ( = 0.22 , P = .048 ) was a significant correlate of global area strain in patients .
-CONCLUSIONS	In adults after tetralogy of Fallot repair , 3D RV deformation is impaired in association with RV dyssynchrony , volume overloading , and reduced EF .
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-###25549485
-OBJECTIVE	The aim of the study was to assess efficacy of high-doses ofantithrombin 111 ( AT ) for treatment of septic shock in patients with an agranulocytosis .
-METHODS	Prospective , controlled study .
-METHODS	29 patients from 18 to 74 years old , with blood diseases complicated with septic shock Dates of study : from 2006 to 2012 .
-METHODS	The patients were randomized into two groups .
-METHODS	Group-1 included 14 patients , who did not receive AT and group-2 included 15 patients who received AT .
-RESULTS	Demographic indicators , condition severity according to APACHE II , level of thrombocytopenia , levels ofplasma procalcitonin , interleukin-6 ( IL-6 ) and C-reactive protein ( CRP ) were the same in both groups .
-RESULTS	Level of AT was decreased in both groups ; however it was higher in the group-1 ( 50 % vs. 60 % , p < 0.05 ) .
-RESULTS	In the group-1 , microorganisms were found in the blood of 9 patients .
-RESULTS	In the group-2 , the microorganisms were found in the blood of 11 patients .
-RESULTS	Inflammation markers were decreased after the treatment of septic shock in both groups ( p < 0.05 ) .
-RESULTS	The decreasing of procalcitonin in group-1 was from 43.8 to 1 ng/ml in 14 days and from 12.8 to 1.6 ng/ml in 7 days in group-2 .
-RESULTS	The decreasing of CRP in group-1 was from 224 to 114 mg/l in 7 days and from 146 to 60 mg/l in 14 days in group-2 .
-RESULTS	The decreasing of IL-6 in group-1 was from 1617 to 100 pg/ml in 3 days and from 5895 to 77 pg/ml in 7 days in group-2 .
-RESULTS	A level of AT was increased only in group-2 ( under 12 % per day ) .
-RESULTS	28-day survival was higher in group-2 ( 60 + / - 13 % vs. 45 + / - 13 % , p < 0.05 ) .
-RESULTS	We did not find any complications of the treatment with AT concentrate .
-CONCLUSIONS	Treatment of septic shock with high-doses of antithrombin III was effective and safe in patients with an agranulocytosis .
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-###25444416
-BACKGROUND	The literature on the effects of massage therapy on neck arthritis pain is mixed depending on the dose level , and it is also based on self-report .
-BACKGROUND	In the present study an attempt was made to enhance the effects of weekly massage therapy by having the participants massage themselves daily .
-BACKGROUND	And in addition to self-reports on pain , range of motion ( ROM ) and the associated ROM pain were assessed before and after the first massage session and pre-post the last session one month later .
-METHODS	Staff and faculty members at a medical school who were eligible for the study if they had neck arthritis pain were randomly assigned to a massage or a waitlist control group ( N = 24 per group ) .
-METHODS	The massage group received moderate pressure massages weekly by a massage therapist plus daily self-massages .
-METHODS	The waitlist control group received the same schedule massages one month after being control subjects .
-RESULTS	The massage group showed significant short-term reductions after the first and last day massages in self-reported pain and in ROM-associated pain as well as an increase in ROM .
-RESULTS	Comparisons between the massage group ( N = 23 ) and the control group ( N = 14 ) on the last versus the first day data suggested significantly different changes including increased ROM and reduced ROM-associated pain for the massage group and reduced ROM and increased ROM-associated pain for the control group .
-RESULTS	These changes occurred specifically for flexion and right and left lateral flexion motions .
-CONCLUSIONS	These data highlight the importance of designing massage therapy protocols that target the most affected neck muscle groups and then assessing range of motion and related pain before and after the massage therapy .
-CONCLUSIONS	Comparisons with other studies also suggest that moderate pressure may contribute to the massage effects , and the use of daily self-massages between sessions may sustain the effects and serve as a cost-effective therapy for individuals with neck arthritis pain .
-
-###25140033
-BACKGROUND	Open mouthpiece ventilation is efficacious in patients with neuromuscular disease .
-BACKGROUND	We used this ventilation technique in patients with exacerbations of COPD with mild to moderate acidosis .
-METHODS	The study was performed in 2 respiratory monitoring care units .
-METHODS	Fifty subjects with exacerbations of COPD , breathing frequency > 25 , PaCO2 > 45 , and pH between 7.25 and 7.30 , as well as Kelly scale 2 were enrolled .
-METHODS	Subjects were randomly assigned to receive noninvasive ventilation ( NIV ) via nasal mask or mouthpiece ventilation .
-METHODS	The primary outcome was improvement in arterial blood gases .
-METHODS	Arterial blood gases and breathing frequency were recorded 2 h after the start of the enrollment and then after 12 , 24 , and 48 h.
-METHODS	The duration of NIV , hospital stay , and acceptability of the interface ( mouthpiece or nasal mask ) using a Likert scale were assessed .
-RESULTS	No subjects had deterioration of gas exchange .
-RESULTS	The 2 groups had similar trends in arterial blood gases and breathing frequency .
-RESULTS	No differences in duration of NIV or hospital stay were noted .
-RESULTS	However , a significant difference in acceptability was found : subjects preferred mouthpiece ventilation ( P < .01 ) .
-CONCLUSIONS	Open mouthpiece ventilation is a useful technique and may prevent further deterioration of gas exchange in COPD patients with mild to moderate acidosis ( similar to traditional NIV delivered by a nasal mask ) .
-CONCLUSIONS	www.chictr.org registration ChiCTR-TRC-12002672 .
-
-###24354930
-OBJECTIVE	To evaluate the effectiveness of information and communication technologies in the undergraduate students ' pressure ulcer training as a learning tool , compared with traditional teaching methods .
-BACKGROUND	Pressure ulcers constitute one of the great challenges faced by nursing professionals .
-BACKGROUND	Currently , pressure ulcer training is based on traditional on-campus teaching , involving lecture-style classes with frequent use of photographs of the wounds .
-BACKGROUND	This traditional training has some important weaknesses that can put the efficacy of the training at risk .
-METHODS	A randomised controlled trial was developed including undergraduate nursing students .
-METHODS	The intervention group used an adaptive self-learning e-learning tool developed by the research team ( ePULab ) for pressure ulcer assessment and treatment .
-METHODS	The control group received a traditional on-campus class on the same topic .
-METHODS	Pretest and post-test questionnaires were designed to assess the students ' ability in pressure ulcer diagnosis and treatment .
-RESULTS	The educational intervention based on the use of the ePULab tool produced significantly better learning acquisition results than those obtained by traditional lecture-style classes : the total score improved in the control group from 823 ( SD 123 ) -116 ( SD 252 ) after the lecture , whereas in the intervention group , the knowledge score changed from 827 ( SD 139 ) -1583 ( SD 252 ) ( p = 001 ) with the use of ePULab .
-CONCLUSIONS	The results show a higher effectiveness of the devised e-learning approach for education on management of pressure ulcers .
-CONCLUSIONS	Our results reveal the suitability of the ePULab e-learning tool as an effective instrument for training on assessment of and treatment for pressure ulcers and its potential impact on clinical decision-making .
-
-###25975632
-BACKGROUND	The ARTemis trial was developed to assess the efficacy and safety of adding bevacizumab to standard neoadjuvant chemotherapy in HER2-negative early breast cancer .
-METHODS	In this randomised , open-label , phase 3 trial , we enrolled women ( 18 years ) with newly diagnosed HER2-negative early invasive breast cancer ( radiological tumour size > 20 mm , with or without axillary involvement ) , at 66 centres in the UK .
-METHODS	Patients were randomly assigned via a central computerised minimisation procedure to three cycles of docetaxel ( 100 mg/m ( 2 ) once every 21 days ) followed by three cycles of fluorouracil ( 500 mg/m ( 2 ) ) , epirubicin ( 100 mg/m ( 2 ) ) , and cyclophosphamide ( 500 mg/m ( 2 ) ) once every 21 days ( D-FEC ) , without or with four cycles of bevacizumab ( 15 mg/kg ) ( Bev + D-FEC ) .
-METHODS	The primary endpoint was pathological complete response , defined as the absence of invasive disease in the breast and axillary lymph nodes , analysed by intention to treat .
-METHODS	The trial has completed and follow-up is ongoing .
-METHODS	This trial is registered with EudraCT ( 2008-002322-11 ) , ISRCTN ( 68502941 ) , and ClinicalTrials.gov ( NCT01093235 ) .
-RESULTS	Between May 7 , 2009 , and Jan 9 , 2013 , we randomly allocated 800 participants to D-FEC ( n = 401 ) and Bev + D-FEC ( n = 399 ) .
-RESULTS	781 patients were available for the primary endpoint analysis .
-RESULTS	Significantly more patients in the bevacizumab group achieved a pathological complete response compared with those treated with chemotherapy alone : 87 ( 22 % , 95 % CI 18-27 ) of 388 patients in the Bev + D-FEC group compared with 66 ( 17 % , 13-21 ) of 393 patients in the D-FEC group ( p = 003 ) .
-RESULTS	Grade 3 and 4 toxicities were reported at expected levels in both groups , although more patients had grade 4 neutropenia in the Bev + D-FEC group than in the D-FEC group ( 85 [ 22 % ] vs 68 [ 17 % ] ) .
-CONCLUSIONS	Addition of four cycles of bevacizumab to D-FEC in HER2-negative early breast cancer significantly improved pathological complete response .
-CONCLUSIONS	However , whether the improvement in pathological complete response will lead to improved disease-free and overall survival outcomes is unknown and will be reported after longer follow-up .
-CONCLUSIONS	Meta-analysis of available neoadjuvant trials is likely to be the only way to define subgroups of early breast cancer that would have clinically significant long-term benefit from bevacizumab treatment .
-BACKGROUND	Cancer Research UK , Roche , Sanofi-Aventis .
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-###24308189
-OBJECTIVE	To observe the clinical effect of electroacupuncture ( EA ) combined with sitting training for cerebral palsy ( CP ) children with parafunctional sitting position .
-METHODS	A total of 120 parafunctional sitting CP child patients were randomly and equally divided into sitting training ( control ) group and EA plus sitting training ( EA ) group .
-METHODS	The sitting training included assistant-sitting , legs-crossing-sitting , sitting with one-leg extending , long-term sitting , balancing-sitting , chair-climbing , and pron and hand-supporting , twice daily .
-METHODS	EA ( 4 Hz , a tolerable strength ) was applied to Mingmen ( GV 4 ) , Jizhong ( GV 6 ) , Shenshu ( BL 23 ) , and Pishu ( BL 20 ) for 30 min , once daily .
-METHODS	Both sitting training and EA treatment were conducted 5 times a week and continuously for a month .
-METHODS	Twenty-items of sitting functions ( 0 - 3 point scaling ) of Gross Motor Function Measure ( GMFM ) were used to evaluate the infantile patients ' motor function and Nimodipine-method was employed to assess the curative effect .
-RESULTS	The sitting function scores were significantly increased in both control and EA groups compared with pre-treatment in the same one group ( P < 0.01 ) , and were apparently higher in the EA group than in the control group ( P < 0.05 ) , suggesting a better therapeutic effect of EA plus sitting training .
-RESULTS	EA plus sitting training intervention was better for the spastic and hypotonic patterns of CP patients than the other patterns in the therapeutic effect ( P < 0.01 ) .
-RESULTS	Of the two 60 cases of CP children in the control and EA groups , 20 ( 33.33 % ) and 22 ( 36.67 % ) experienced marked improvement , 24 ( 40.00 % ) and 30 ( 50.00 % ) were effective , and 16 ( 26.67 % ) and 8 ( 13.33 % ) failed , with the effective rates being 73.33 % and 86.67 % respectively .
-CONCLUSIONS	Acupuncture intervention combined with sitting training is better than sitting training intervention alone in improving cerebral palsy children with parafunctional sitting position , especially for the spastic and hypotonic CP patients .
-
-###24386406
-OBJECTIVE	The population-based `` Asymptomatic Polyvascular Abnormalities in Community ( APAC ) Study was designed to examine prevalence and associations of asymptomatic polyvascular abnormalities ( APA ) in a general population .
-OBJECTIVE	In this report , the objectives , design and baseline data of the APAC study are described .
-METHODS	The study included 5,440 participants ( 40.1 % women ) with an age of 40 + years who were randomly selected from the population of the Kailuan Study which included 101,510 employees and retirees of the Kailuan Co. Ltd , a large coal mine industry located in Tangshan , Hebei , China .
-METHODS	Exclusion criteria were previous cerebral stroke , transient ischemic attacks and coronary heart disease .
-METHODS	In 2010 and 2011 , information on potential cardiovascular risk factors was collected and all participants underwent transcranial Doppler sonography , measurement of the ankle brachial index , and bilateral carotid duplex sonography .
-METHODS	In a first follow-up examination in 2012/2013 , retinal photography and spectral-domain optical coherence tomography were additionally performed .
-METHODS	In a planned long-term follow-up , data from clinical examinations and laboratory tests and the occurrence of cardiovascular or cerebrovascular events will be collected to build up a predicting model for the risk of ischemic events .
-RESULTS	At baseline , mean age of the participants was 55.2 11.8 years , and men showed a significantly ( P < 0.001 ) higher prevalence of arterial hypertension ( 55.5 % vs. 36.5 % ) and hyperlipidemia ( 50.7 % vs. 46.0 % ) and a higher blood homocysteine concentration ( 18.68 10.28 mol/L versus 11.69 6.40 mol/L ) .
-CONCLUSIONS	The APAC is the first study to prospectively evaluate the relationship between intracranial arterial stenosis , retinal nerve fiber layer changes , retinal microvascular signs , and the eventual development of cerebrovascular or cardiovascular events .
-
-###25470094
-BACKGROUND	Vilazodone is a potent serotonin ( 5-HT ) reuptake inhibitor and 5-HTA receptor partial agonist approved by the US Food and Drug Administration for the treatment of major depressive disorder ( MDD ) in adults .
-BACKGROUND	This study evaluated the efficacy and tolerability of vilazodone in the treatment of MDD .
-METHODS	This 8-week , randomized ( 1:1 ) , double-blind , placebo-controlled , parallel-group , fixed-dose study conducted from January 2012 to February 2013 compared vilazodone 40 mg/d with placebo in outpatients with DSM-IV-TR-diagnosed MDD .
-METHODS	The primary efficacy measure was Montgomery-Asberg Depression Rating Scale ( MADRS ) total score change from baseline to week 8 analyzed by a mixed-effects model for repeated measures on the intent-to-treat population ( placebo = 252 , vilazodone = 253 ) .
-METHODS	Secondary efficacy outcomes were Clinical Global Impressions-Severity of Illness ( CGI-S ) Scale score change from baseline and MADRS sustained response rate ( total score 12 for at least the last 2 consecutive double-blind visits ) .
-RESULTS	Approximately 83 % of patients completed the study .
-RESULTS	Least squares mean differences ( 95 % CI ) were statistically significant for vilazodone versus placebo on MADRS ( -5.117 [ -6.886 to -3.347 ] , P < .00001 ) and CGI-S ( -0.622 [ -0.845 to -0.399 ] , P < .00001 ) change from baseline ; statistically significant improvements versus placebo occurred at week 2 and persisted for the study duration .
-RESULTS	The MADRS sustained response rate was 17 % for placebo and 27 % for vilazodone ( P < .01 ) .
-RESULTS	Patients taking vilazodone versus placebo had higher rates of diarrhea and nausea ; most incidences were mild in severity .
-RESULTS	Weight increase and sexual dysfunction adverse events were low in both groups .
-CONCLUSIONS	A large and significant treatment effect on the MADRS and statistically significant improvement on the CGI-S demonstrated meaningful depressive symptom improvements .
-CONCLUSIONS	Vilazodone was generally well tolerated .
-BACKGROUND	ClinicalTrials.gov identifier : NCT01473394 .
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-###25616350
-BACKGROUND	Endoscopic biliary drainage is the palliative treatment of choice in patients with malignant hilar biliary obstruction .
-BACKGROUND	Contrast injection can lead to cholangitis , whereas air cholangiography may have a lesser incidence of cholangitis .
-OBJECTIVE	The objective of the present study is to prospectively compare the efficacy and safety of air vs. dye cholangiogram in malignant hilar biliary obstruction .
-METHODS	Patients with type II and III malignant hilar biliary stricture were included in a prospectively randomized manner at a tertiary care center .
-METHODS	Unilateral self-expanding metal stent was placed in patients with a malignant hilar block using either air or dye as a contrast medium .
-METHODS	Outcome measures were successful deployment , successful drainage , early complications , and procedure-related and 30-day mortality .
-RESULTS	Forty-nine patients were randomized to air cholangiogram ( 25 patients , group A ) or dye cholangiogram ( 24 patients , group B ) .
-RESULTS	Most of the patients had type II stricture ( 19 in group A and 20 in group B ) .
-RESULTS	Successful stenting and drainage were achieved in 25 ( 100 % ) and 24 ( 96 % ) in group A and 23 ( 95.8 % ) and 22 ( 91.6 % ) ( p = ns ) , respectively .
-RESULTS	Cholangitis developed in 1 ( 4 % ) and 4 ( 16.6 % ) in group A and B , respectively ( p < 0.05 ) .
-RESULTS	There was no procedure-related or 30-day mortality .
-CONCLUSIONS	Use of air cholangiography was as safe and as effective as dye cholangiography in patients with malignant hilar biliary obstruction , and it decreased the risk of post-ERCP cholangitis .
-
-###24755046
-OBJECTIVE	To compare oxygen cost ( mLkg ( -1 ) m ( -1 ) ) and cardiovascular response ( beats/m ) and oxygen consumption ( mLkg ( -1 ) min ( -1 ) ) and heart rate ( beats/min ) to stair ascending and descending with walkers , with canes , and without assistive devices ( ADs ) in older adults .
-METHODS	Descriptive , repeated measures .
-METHODS	Indoor stairway .
-METHODS	Convenience sample of able-bodied volunteers , non-AD users ( N = 14 ; mean age , 63.71 11.7 y ; mean body mass , 72.7 14.1 kg ; mean height , 165.7 9.2 cm ) .
-METHODS	Participants performed 4 randomized trials of stair ascending and descending at their own self-selected speed with 3 ADs : single-point cane , standard walker ( SW ) , and wheeled walker ( WW ) .
-METHODS	They also performed unassisted stair ascending and descending .
-METHODS	Each trial consisted of a 5-minute steady-state session followed by a 2-minute data collection period .
-METHODS	Steady-state expired ventilations were collected in Douglas bags for metabolic analysis .
-METHODS	Oxygen cost ( mLkg ( -1 ) m ( -1 ) ) , heart rate ( HR ) response ( beats/m ) , oxygen consumption ( mLkg ( -1 ) min ( -1 ) ) , and HR ( beats/min ) were compared for each trial of stair ascending and descending using analysis of variance repeated measures ( P < .05 ) .
-RESULTS	Greater oxygen cost ( per meter ) was found for stair ascending and descending using the single-point cane ( 121 % ) , SW ( 217 % ) , and WW ( 232 % ) compared with unassisted stair ascending and descending ( P < .05 ) .
-RESULTS	Increased HR response ( per meter ) was found for stair ascending and descending using the single-point cane ( 116 % ) , SW ( 126 % ) , and WW ( 147 % ) compared with unassisted stair ascending and descending ( P < .05 ) .
-RESULTS	However , oxygen consumption ( per minute ) and HR ( per minute ) were not significantly increased during stair ascending and descending with the ADs compared with unassisted stair ascending and descending .
-RESULTS	Participants stair ascended and descended at significantly ( P < .05 ) reduced speeds during trials with the ADs .
-CONCLUSIONS	This research should aid clinicians by providing evidence to base recommendations on regarding AD usage when encountering stairs during home and community ambulation .
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-###24373555
-BACKGROUND	Nonalcoholic fatty liver disease ( NAFLD ) is one of the commonest liver disorders .
-BACKGROUND	Obesity , insulin resistance , lipid peroxidation and oxidative stress have been identified amongst the possible hits leading to the onset and progression of this disease .
-BACKGROUND	Nutritional evaluation of NAFLD patients showed a lower-than-recommended intake of vitamin E. Vitamin E is a family of 8 isoforms , 4 tocopherols and 4 tocotrienols .
-BACKGROUND	Alpha-tocopherol has been widely investigated in liver diseases , whereas no previous clinical trial has investigated tocotrienols for NAFLD .
-BACKGROUND	Aim of the study was to determine the effects of mixed tocotrienols , in normalising the hepatic echogenic response in hypercholesterolaemic patients with ultrasound-proven NAFLD .
-METHODS	Eighty-seven untreated hypercholesterolaemic adults with ultrasound-proven NAFLD were enrolled and randomised into control group ( n = 44 ) and tocotrienols group ( n = 43 ) .
-METHODS	The treatment , either mixed tocotrienols 200 mg twice daily or placebo , had a 1-year duration.Normalisation of hepatic echogenic response , being the trial primary aim , was used in sample size calculations .
-METHODS	The data were assessed according to intention to treat principle as primary outcome .
-METHODS	Per protocol analysis was also carried out as secondary outcome measurement .
-RESULTS	Thirty and 34 participants concluded the study in the tocotrienols and placebo group respectively .
-RESULTS	Alpha-tocopherol levels were within the normal range for all subjects .
-RESULTS	As primary outcome , the normalisation of hepatic echogenic response was significantly higher for the tocotrienols treated group compared to the placebo group in the intention to treat analysis ( P = 0.039 ; 95 % CI = 0.896-6 .488 ) .
-RESULTS	As secondary objective , the per protocol assessment also showed significant rate of remission ( P = 0.014 ; 95 % CI = 1.117-9 .456 ) .
-RESULTS	Worsening of NAFLD grade was recorded in two patients in the placebo group , but none in the group treated with tocotrienols .
-RESULTS	No adverse events were reported for both groups .
-CONCLUSIONS	This is the first clinical trial that showed the hepatoprotective effects of mixed palm tocotrienols in hypercholesterolemic adults with NAFLD .
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-###24423149
-BACKGROUND	Patients with diabetes mellitus are at increased risk for microvascular complications .
-BACKGROUND	Early changes in microcirculation are characterized by hyperperfusion ( e.g. in the retina and kidney ) and increased pulse wave reflection leading to increased aortic pressure .
-BACKGROUND	We investigated the effects of the DPP-4-inhibitor saxagliptin on early retinal microvascular changes .
-METHODS	In this double-blind , controlled , cross-over trial 50 patients ( without clinical signs of microvascular alterations ) with type-2 diabetes ( mean duration of 4 years ) were randomized to receive placebo or 5mg saxagliptin for 6 weeks .
-METHODS	Retinal arteriolar structure and retinal capillary flow ( RCF ) at baseline and during flicker-light exposure was assessed by scanning laser Doppler flowmetry .
-METHODS	Central hemodynamics were assessed by pulse wave analysis .
-RESULTS	Postprandial blood glucose ( 9.270.4 versus 10.10.4 mmol/L ; p = 0.001 ) and HbA1c ( 6.840.15 ( 511.6 ) versus 7.100.17 % ( 541.9 mmol/mol ) ; p < 0.001 ) were significantly reduced with saxagliptin treatment compared to placebo .
-RESULTS	RCF was significantly reduced after treatment with saxagliptin ( 28813.2 versus 31414.1 AU ; p = 0.033 ) .
-RESULTS	This was most pronounced in a subgroup of patients ( n = 32 ) with a fall in postprandial blood glucose ( 28012.1 versus 31416.6 AU ; p = 0.011 ) .
-RESULTS	No significant changes in RCF were seen during flicker-light exposure between placebo and saxagliptin , but the vasodilatory capacity increased two-fold with saxagliptin treatment .
-RESULTS	Central augmentation pressure tended to be lower after treatment with saxagliptin ( p = 0.094 ) , and central systolic blood pressure was significantly reduced ( 1192.3 versus 1242.3 mmHg ; p = 0.038 ) .
-CONCLUSIONS	Our data suggest that treatment with saxagliptin for 6 weeks normalizes retinal capillary flow and improves central hemodynamics in type-2 diabetes .
-BACKGROUND	The study was registered at ( ID : NCT01319357 ) .
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-###24483103
-OBJECTIVE	To observe the clinical efficacy of treating chronic hepatitis B liver fibrosis ( CHBLF ) in different stages by syndrome typing and different activating blood removing stasis methods ( ABRSM ) .
-METHODS	Totally 100 CHBLF patients of vital qi deficiency blood stasis syndrome ( VQDBSS ) treated at the Department of Liver Diseases , Xiyuan Hospital , China Academy of Chinese Medical Sciences from July 2008 to December 2011 , were randomly assigned to the treatment group and the control group , 50 in each group .
-METHODS	Those in the treatment group were treated by self-formulated decoctions for activating blood nourishing blood ( ABNB ) , activating blood removing stasis ( ABRS ) , and activating blood softening hard mass ( ABSHM ) according to their stages of disease conditions ( mild , moderate , and severe ) .
-METHODS	Those in the control group were treated with Compound Biejia Ruangan Tablet ( CBRT ) .
-METHODS	Integrals of Chinese medical syndromes , liver functions [ mainly including alanine aminotransferase ( ALT ) , albumin/globulin ( A / G ) ] , ultrasonographic examinations of liver ( mainly including echoes of liver , width of spleens , width of portal vein ) , four indicators of serum hepatic fibrosis [ including serum hyaluronic acid ( HA ) , laminin ( LN ) , type IV collagen ( IV-C ) , type III collagen peptide ( P-III-P ) ] were statistically analyzed .
-METHODS	The therapeutic course was 6 months for all .
-RESULTS	Compared with before treatment in the same group , the integrals of Chinese medical syndromes both decreased after treatment in the two groups ( P < 0.05 ) .
-RESULTS	The width of spleens decreased in the treatment group more obviously after treatment than before treatment ( P < 0.05 ) .
-RESULTS	Compared with the control group , the integrals of Chinese medical syndromes and the width of spleens were more obviously improved in the treatment group , showing statistical difference ( P < 0.05 ) .
-RESULTS	Compared with before treatment in the same group , levels of ALT , HA , and LN significantly decreased , and the level of A/G significantly increased after treatment in the two groups , showing statistical difference ( P < 0.05 ) .
-RESULTS	Compared with the control group , the A/G level , HA , and LN were more obviously improved in the treatment group , showing statistical difference ( P < 0.05 ) .
-RESULTS	The total effective rate was 76 % in the treatment group and 46 % in the control group , showing statistical difference ( P < 0.05 ) .
-CONCLUSIONS	Treating CH-BLF in different stages by ABRSM got better effect than using CBRT alone .
-CONCLUSIONS	It could favorably improve clinical symptoms of CHBLF patients and their serum biochemical indicators .
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-###26182747
-BACKGROUND	Atherosclerotic peripheral arterial disease ( PAD ) is prevalent affecting up to 16 % of the population aged 55 years or older .
-BACKGROUND	Endovascular intervention for the treatment of limb ischemia has become the first line therapy but in Pakistan it is in embryonic stage due to dearth of trained persons and dedicated centres .
-BACKGROUND	This study was conducted to evaluate procedural success and early outcome of endovascular treatment of peripheral vascular disease .
-METHODS	A prospective single arm multicentre study was conducted at the National Institute of Cardiovascular Disease and National Medical Centre , Karachi , Pakistan from January 2013 to June 2014 .
-METHODS	A total of 25 patients were enrolled in the study that underwent endovascular treatment .
-METHODS	Out of 25 patients 23 ( 92 % ) had critical limb ischemia ( CLI ) as per TASC II classification ( A to D ) and 2 ( 8 % ) had carotid lesion with history of TIA .
-METHODS	Patients of acute limb ischemia and stroke were excluded .
-METHODS	Ankle brachial index ( ABI ) was classified as normal ( 0.9-1 .3 ) , mild ( 0.7-0 .9 ) , moderate ( 0.4-0 .69 ) , severe .
-METHODS	( < 0.4 ) .
-METHODS	Outcome was taken as immediate success and symptoms , amputation of limb among CLI patients and incidence of stroke in patients with carotid artery lesion at end of six months .
-RESULTS	Among aortoiliac , femoropopliteal and tibioperoneal lesions , tibioperoneal lesions at six months were found to be more symptomatic 6 ( 86 % ) and amputation 4 ( 57 % ) .
-RESULTS	Two carotid lesions at follow up were asymptomatic without stroke .
-CONCLUSIONS	Endovascular treatment of peripheral vascular lesions , i.e. , aortoiliac , femoropopliteal tibioperoneal and carotid lesions were satisfactory in immediate outcome .
-CONCLUSIONS	Tibioperoneal lesions were more symptomatic and limb amputation at six months .
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-###24660950
-OBJECTIVE	The purpose of the study was to characterize and compare participants ' experiences of peer-facilitated versus clinician-facilitated recovery groups for veterans with mental illness .
-METHODS	We analyzed qualitative data from 24 interviews with veterans who participated in mental health recovery groups led by peer or clinician facilitators .
-RESULTS	Subtle differences in group structure , participation/communication and utility/relevance between peer - and clinician-facilitated groups were identified .
-RESULTS	Participants experienced both peer and clinician facilitators as helpful in promoting recovery , though they appeared to do this in different ways .
-CONCLUSIONS	Peer and clinician facilitators offer different strengths in the promotion of mental health recovery .
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-###24279429
-OBJECTIVE	Research indicates that death thoughts that occur in response to health threats affect subsequent health behaviour .
-OBJECTIVE	The present study examined the effects of mortality salience on HIV testing .
-METHODS	After reading an article that was intended to make them perceive that they had high or low vulnerability to HIV , participants wrote about death or an aversive control topic .
-METHODS	Participants then indicated their intentions to get tested for HIV and were given the opportunity to take an HIV test at the end of the study .
-RESULTS	Results showed that mortality salience increased testing behaviour among participants who were made to feel vulnerable to HIV , but decreased testing behaviour among participants who were not made to feel vulnerable to HIV infection .
-CONCLUSIONS	This research suggests that HIV prevention programmes must carefully consider how the association many people make between HIV and death may interact with people 's perceptions of their vulnerability to HIV infection to affect their willingness to engage in preventative behaviours .
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-###24450891
-BACKGROUND	Bapineuzumab , a humanized anti-amyloid-beta monoclonal antibody , is in clinical development for the treatment of Alzheimer 's disease .
-METHODS	We conducted two double-blind , randomized , placebo-controlled , phase 3 trials involving patients with mild-to-moderate Alzheimer 's disease -- one involving 1121 carriers of the apolipoprotein E ( APOE ) 4 allele and the other involving 1331 noncarriers .
-METHODS	Bapineuzumab or placebo , with doses varying by study , was administered by intravenous infusion every 13 weeks for 78 weeks .
-METHODS	The primary outcome measures were scores on the 11-item cognitive subscale of the Alzheimer 's Disease Assessment Scale ( ADAS-cog11 , with scores ranging from 0 to 70 and higher scores indicating greater impairment ) and the Disability Assessment for Dementia ( DAD , with scores ranging from 0 to 100 and higher scores indicating less impairment ) .
-METHODS	A total of 1090 carriers and 1114 noncarriers were included in the efficacy analysis .
-METHODS	Secondary outcome measures included findings on positron-emission tomographic amyloid imaging with the use of Pittsburgh compound B ( PIB-PET ) and cerebrospinal fluid phosphorylated tau ( phospho-tau ) concentrations .
-RESULTS	There were no significant between-group differences in the primary outcomes .
-RESULTS	At week 78 , the between-group differences in the change from baseline in the ADAS-cog11 and DAD scores ( bapineuzumab group minus placebo group ) were -0.2 ( P = 0.80 ) and -1.2 ( P = 0.34 ) , respectively , in the carrier study ; the corresponding differences in the noncarrier study were -0.3 ( P = 0.64 ) and 2.8 ( P = 0.07 ) with the 0.5-mg-per-kilogram dose of bapineuzumab and 0.4 ( P = 0.62 ) and 0.9 ( P = 0.55 ) with the 1.0-mg-per-kilogram dose .
-RESULTS	The major safety finding was amyloid-related imaging abnormalities with edema among patients receiving bapineuzumab , which increased with bapineuzumab dose and APOE 4 allele number and which led to discontinuation of the 2.0-mg-per-kilogram dose .
-RESULTS	Between-group differences were observed with respect to PIB-PET and cerebrospinal fluid phospho-tau concentrations in APOE 4 allele carriers but not in noncarriers .
-CONCLUSIONS	Bapineuzumab did not improve clinical outcomes in patients with Alzheimer 's disease , despite treatment differences in biomarkers observed in APOE 4 carriers .
-CONCLUSIONS	( Funded by Janssen Alzheimer Immunotherapy and Pfizer ; Bapineuzumab 301 and 302 ClinicalTrials.gov numbers , NCT00575055 and NCT00574132 , and EudraCT number , 2009-012748-17 . )
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-###24335927
-BACKGROUND	Currently , the reference standard used to clinically assess sexual function among women is a qualitative questionnaire .
-BACKGROUND	Hence , a generalised and quantitative measurement tool needs to be available as an alternative .
-BACKGROUND	This study investigated whether an electromyography ( EMG ) measurement technique could be used to help quantify women 's sexual function .
-METHODS	A preliminary intervention study was conducted on 12 female subjects , who were randomised into a control ( n = 6 ) and an intervention ( n = 6 ) group .
-METHODS	Intervention involved a set regimen of pelvic floor muscle exercises ( Kegel ) and the control group did not have any treatment .
-METHODS	All subjects were asked to answer a validated , self-rated Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire ( PISQ ) .
-METHODS	EMG measurements of the pelvic floor muscles ( PFM ) and the abdominal muscles were taken from all women at recruitment and 8 weeks after study commencement .
-RESULTS	After 8 weeks , most of the subjects in the control group did not display any noted positive difference in either PISQ score ( 4/6 ) or in their muscle strength ( 4/6 ) .
-RESULTS	However , a noted progressive difference were observed in subjects who were placed in the Kegel group ; PISQ score ( 5/6 ) and muscles strength ( 4/6 ) .
-CONCLUSIONS	The noted difference in the Kegel group subjects was that if progress is observed in the sexual function , improvement is also observed in the strength of at least 2 types of muscles ( either abdominal or PFM muscles ) .
-CONCLUSIONS	Thus , EMG measurement is a potential technique to quantify the changes in female sexual function .
-CONCLUSIONS	Further work will be conducted to validate this assumption .
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-###25198224
-OBJECTIVE	Interventions utilizing vibration may increase bone mass and size which may reduce forearm fractures in children .
-OBJECTIVE	This randomized controlled pilot trial tested the feasibility , compliance and efficacy of forearm loading regimes in an after-school program in pre-pubertal children aged 6-10 years .
-METHODS	A 12-week randomized controlled trial incorporated high ( HMMS ; N = 10 ) and low ( LMMS ; N = 10 ) magnitude mechanical stimulation vibration , floor exercises ( N = 9 ) , and controls ( N = 10 ) .
-METHODS	Radial bone measures by DXA and pQCT were compared at the end of intervention ( 12-weeks ) and 4-months post-intervention ( 4-months post ) .
-RESULTS	Percent changes were significantly greater in floor vs. control for ultra-distal areal BMD by DXA at 12-weeks ( 1 % [ -2,5 ] vs.-5 % [ -8 , -2 ] respectively , p = 0.02 ) and 4-months post ( 5 % [ 1,8 ] vs -2 % [ -5,2 ] , p = 0.03 ) and in HMMS vs. controls for trabecular vBMD by pQCT at 12-weeks ( 4 % [ 0 , 8 ] , vs. -8 % [ -14 , -2 ] , p = 0.02 ) .
-RESULTS	Children exposed to HMMS showed positive changes in cortical BMC , area , and cortical vBMD after 12 weeks that remained 4 months post-intervention .
-RESULTS	Children exposed to floor exercise showed positive changes in cortical BMC , area , and periosteal circumference 4-months post-intervention .
-RESULTS	Controls had decreased trabecular BMD , but increased bone area and periosteal circumference .
-CONCLUSIONS	Exposure to floor exercise and HMMS increased trabecular aBMD and vBMD in the radius .
-
-###25070546
-BACKGROUND	We investigated whether the Src inhibitor saracatinib ( AZD0530 ) improved efficacy of weekly paclitaxel in platinum-resistant ovarian cancer .
-METHODS	Patients with platinum-resistant ovarian , fallopian tube or primary peritoneal cancer were randomised 2 : 1 to receive 8-week cycles of weekly paclitaxel ( wPxl ; 80 mg/m ( 2 ) / week 6 with 2-week break ) plus saracatinib ( S ; 175 mg o.d. ) or placebo ( P ) continuously , starting 1 week before wPxl , until disease progression .
-METHODS	Patients were stratified by taxane-free interval ( < 6 versus 6 months/no prior taxane ) .
-METHODS	The primary end point was progression-free survival ( PFS ) rate at 6 months .
-METHODS	Secondary end points included overall survival ( OS ) and response rate ( RR ) .
-RESULTS	A total of 107 patients , median age 63 years , were randomised .
-RESULTS	Forty-three ( 40 % ) had received > 2 lines of prior chemotherapy .
-RESULTS	The 6-month PFS rate was 29 % ( wPxl + S ) versus 34 % ( wPxl + P ) ( P = 0.582 ) .
-RESULTS	Median PFS was 4.7 versus 5.3 months ( hazard ratio 1.00 , 95 % confidence interval 0.65-1 .54 ; P = 0.99 ) .
-RESULTS	RR ( complete + partial ) was 29 % ( wPxl + S ) versus 43 % ( wPxl + P ) , P value = 0.158 .
-RESULTS	Grade 3/4 adverse events were 36 % versus 31 % ( P = 0.624 ) ; the most frequent G3/4 toxicities were vomiting ( 5.8 % saracatinib versus 8.6 % placebo ) , abdominal pain ( 5.8 % versus 0 % ) and diarrhoea ( 4.3 % versus 5.7 % ) .
-RESULTS	Febrile neutropenia was more common in the saracatinib arm ( 4.3 % ) than placebo ( 0 % ) .
-RESULTS	Response , PFS and OS were all significantly ( P < 0.05 ) better in patients with taxane interval 6 months/no prior taxane ( n = 85 ) than those < 6 months ( n = 22 ) , regardless of randomisation .
-CONCLUSIONS	Saracatinib does not improve activity of weekly paclitaxel in platinum-resistant ovarian cancer .
-CONCLUSIONS	Taxane-free interval of 6 months/no prior taxane was associated with better outcome in both groups .
-BACKGROUND	Clinicaltrials.gov NCT01196741 ; ISRCTN 32163062 .
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-###25483563
-OBJECTIVE	Gastroesophageal reflux disease ( GERD ) is a common condition associated with symptoms as heart burn , regurgitation , chest pain , and gastrointestinal discomfort .
-OBJECTIVE	PPC-5650 is a new pharmacological agent that can modulate acid-sensing ion channel activity , potentially leading to reduction in the pain signal .
-OBJECTIVE	In healthy volunteers the esophagus was sensitized with acid to mimic GERD with the aims : 1 ) to assess the efficacy of a single bolus of PPC-5650 locally applied to the esophagus using multimodal pain stimulations , and 2 ) to assess the safety profile of PPC-5650 .
-METHODS	The study was a randomized , double-blinded , placebo-controlled , crossover trial in healthy males .
-METHODS	Esophageal electrical , thermal , mechanical , and chemical stimulations were performed , pain perception was rated , and referred pain areas were drawn .
-METHODS	Sensitization was induced by intraluminal esophageal acid perfusions .
-METHODS	Adverse events were registered .
-RESULTS	Twenty-five healthy males completed the study ( mean age 23.4 2.0 years ) .
-RESULTS	About 90 min after drug administration , PPC-5650 increased the volume tolerated at moderate pain during mechanical stimulation compared to placebo ( difference 13.5 , 95 % CI : 0.58-26 .47 , p = 0.04 ) , but there was no effects on thermal - , electrical - , and chemical-induced pain ( all p > 0.05 ) .
-RESULTS	PPC-5650 did not affect referred pain areas to any stimulation ( all p > 0.05 ) .
-RESULTS	Ten participants reported adverse events during the placebo treatment period , and nine participants reported adverse events during the PPC-5650 treatment period ( p = 0.8 ) .
-CONCLUSIONS	Sensitization to mechanical stimulation of the esophagus was reduced by PPC-5650 compared to placebo .
-CONCLUSIONS	The overall safety and tolerability of PPC-5650 was acceptable .
-CONCLUSIONS	Thus , PPC-5650 may play a role in the future treatment of patients with GERD .
-
-###25672160
-BACKGROUND	Otitis media with effusion ( OME ) or middle ear effusion ( MEE ) is a common cause of hearing difficulty in children .
-BACKGROUND	MEE must be detected early and managed properly to prevent conductive hearing loss in children .
-BACKGROUND	It was aimed to compare results of laser myringotomy and conventional myringotomy in terms of hearing improvement , recurrence of MEE and time to put ventilation tube .
-METHODS	This randomized control trial was conducted from February 2012 to April 2014 .
-METHODS	Children of 4 years age or older with MEE were included in the study .
-METHODS	These children were investigated with Pure tone audiometry ( PTA ) and tympanometry to confirm conductive hearing loss .
-METHODS	X-Ray nasopharynx lateral view was performed for adenoids .
-METHODS	Sixty-six patients were randomly assigned in to 2 groups , ( 1 ) treated with laser myringotomy and ( 2 ) treated with classical myringotomy .
-METHODS	The ears were evaluated for MEE , for presence of perforation and level of hearing .
-RESULTS	A total of 98 ears in 66 patients underwent intervention .
-RESULTS	Middle ear effusion cleared in 44 out of 48 ears with laser myringotomy ( LM ) as compared to34 out of 50 ears with incisional myringotomy .
-RESULTS	The perforation was still patent in 36 ears treated with LM while it was found closed in all 50 ears with conventional myringotomy after 2 weeks .
-RESULTS	The hearing level improved with LM by 10-15 dB after first 3 months .
-CONCLUSIONS	The aim of management in otitis media with effusion is ventilation of tympanic cavity .
-CONCLUSIONS	Laser myringotomy is a best alternative to conventional one .
-CONCLUSIONS	It also has comparable results with ventilation tubes ( VT ) .
-CONCLUSIONS	The ears with refractory or recurrent MEE should have VT insertion .
-
-###24783602
-BACKGROUND	One of the concerns in the use of propofol is the pain on injection of the drug .
-BACKGROUND	Many attempts were made to prevent such pain , none of which has been reasonably successful .
-BACKGROUND	We hypothesized that the pain is attenuated when the patient is directed to concentrate on counting numbers while propofol is injected .
-METHODS	Ninety-one patients undergoing elective surgery under general anesthesia were enrolled .
-METHODS	They were randomly assigned to counting or non-counting group .
-METHODS	Patients in counting group were instructed to verbally count numbers backwards starting 100 when propofol was injected , while patients in non-counting group were injected propofol without any instructions .
-METHODS	The size of the i.v. cannula , the temperature of the drug , and speed by which the drug was injected were controlled .
-METHODS	No premedication was given .
-METHODS	We interviewed the patients after the surgery and scored the pain on propofol injection , the pain on the placement of the iv cannula , and the anxiety level on entering the operating room .
-RESULTS	There was no significant difference in the incidence of pain on injection of propofol ( 34 % and 33 % in the counting and the non-counting group , respectively ) .
-RESULTS	A multiple logistic-regression analysis revealed that the significant factors to cause pain on the injection of propofol were age and the degree of pain on inserting intravenous line .
-CONCLUSIONS	Intensive counting did not reduce the incidence of pain on injection of propofol .
-CONCLUSIONS	Age and the degree of pain on inserting intravenous cannula can be a useful predictor for an intolerable pain on injection of propofol .
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-###26237980
-OBJECTIVE	To observe the clinical effedt of auricular pressure combined with Chinese herbal medicine for amblyopia .
-METHODS	A total of 66 child patients with amblyopia were randomly divided into Chinese herbal medicine ( control ) and herbal medicine + auricular pressure ( treatment ) groups , with 33 patients in each group .
-METHODS	The patients in the control group were treated with Chinese medical herbs as Danggui ( Radix Angelicae Sinensis ) , Gouqizi ( Fructus Lycii ) , Baijuhua ( Flos Chrysanthemi ) , Baizhu ( Rhizoma Atractylodis Macrocephalae ) , Shudi ( Radix Rehmanniae Proeparata ) , Baishao ( Radix Paeoniae Alba ) , etc. according to syndrome differentiation , while the patients in the treatment group were treated by auricular pressure of otopoints Yan ( Eye ) , Gan ( Liver ) , Shen ( Kidney ) , Xin ( Heart ) , Mu 1 ( Eye-1 ) , Mu 2 ( Eye-2 ) , and Pi ( Spleen ) and herbal medicines ( being the same to the control group ) .
-METHODS	The treatment was conducted for 6 months .
-METHODS	After the treatment , the clinical effect , improvement degree of vision , onset time of improvement , and recurrence rate in the 3 and 6 months ' follow-up visit were analyzed .
-RESULTS	Of the 45 and 47 eyes in the treatment and control groups , 22 and 15 were basically cured , 12 and 5 had marked improvement , 9 and 20 were improved , 2 and 7 failed in the treatment , with the effective rates being 75.56 % and 42.55 % , respectively .
-RESULTS	In comparison with pre-treatment , the visual acuity in both control group and treatment group were improved ( P < 0.05 ) .
-RESULTS	The numbers of children who had improvement of visual acuity after 2 weeks , one month in the control group and treatment group were 26 and 31 eyes , 10 and 11 eyes , respectively .
-RESULTS	The recurrence rate 6 months after the treatment was 50.00 % in the control group and 16.28 % in the treatment group .
-RESULTS	The effective rate of the treatment group was significantly superior to that of the control group ( P < 0.05 ) .
-CONCLUSIONS	Auricular pressure combined with Chinese medical herb treatment is effective in improving visual acuity , and had a higher efficacy , faster action , and lower recurrence rate in amblyopia children in comparison with simple herbal medicine treatment .
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-###24945241
-BACKGROUND	Physical activity is mandatory if patients are to remain healthy and independent after stroke .
-OBJECTIVE	Maintenance of motor function , tone , grip strength , balance , mobility , gait , independence in personal and instrumental activities of daily living , health-related quality-of-life and an active lifestyle 4 years post-stroke .
-METHODS	A prospective randomized controlled trial .
-RESULTS	Four years post-stroke , 37 of the 75 participating persons were eligible for follow-up ; 19 ( 54.3 % ) from the intensive exercise group and 18 ( 45 % ) from the regular exercise group .
-RESULTS	Both groups were performing equally well with no significant differences in total scores on the BI ( p = 0.3 ) , MAS ( p = 0.4 ) , BBS ( p = 0.1 ) , TUG ( p = 0.08 ) , 6MWT ( p = 0.1 ) , bilateral grip strength ( affected hand , p = 0.8 ; non-affected hand , p = 0.9 ) nor in the items of NHP ( p > 0.005 ) .
-RESULTS	Independence in performing the IADL was 40 % , while 60 % had help from relatives or community-based services .
-CONCLUSIONS	This longitudinal study shows that persons with stroke in two groups with different exercise regimes during the first year after stroke did not differ in long-term outcomes .
-CONCLUSIONS	Both groups maintained function and had a relatively active life style 4 years after the acute incident .
-CONCLUSIONS	The results underline the importance of follow-up testing and encouragement to exercise , to motivate and sustain physical activity patterns , to maintain physical function , not only in the acute but also in the chronic phase of stroke .
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-###24372522
-OBJECTIVE	The objectives of this study were to determine the effects of the novel Buddhism-based walking meditation ( BWM ) and the traditional walking exercise ( TWE ) on depression , functional fitness , and vascular reactivity .
-METHODS	This was a randomized exercise intervention study .
-METHODS	The study was conducted in a university hospital setting .
-METHODS	Forty-five elderly participants aged 60-90 years with mild-to-moderate depressive symptoms were randomly allocated to the sedentary control , TWE , and BWM groups .
-METHODS	The BWM program was based on aerobic walking exercise incorporating the Buddhist meditations performed 3 times/week for 12 weeks .
-METHODS	Depression score , functional fitness , and endothelium-dependent vasodilation as measured by the flow-mediated dilation ( FMD ) were the outcome measures used .
-RESULTS	Muscle strength , flexibility , agility , dynamic balance , and cardiorespiratory endurance increased in both exercise groups ( p < 0.05 ) .
-RESULTS	Depression score decreased ( p < 0.05 ) only in the BWM group .
-RESULTS	FMD improved ( p < 0.05 ) in both exercise groups .
-RESULTS	Significant reduction in plasma cholesterol , triglyceride , high-density lipoprotein cholesterol , and C-reactive protein were found in both exercise groups , whereas low-density lipoprotein cholesterol , cortisol , and interleukin-6 concentrations decreased only in the BWM group .
-CONCLUSIONS	Buddhist walking meditation was effective in reducing depression , improving functional fitness and vascular reactivity , and appears to confer greater overall improvements than the traditional walking program .
-
-###25854015
-OBJECTIVE	To observe the clinical effect of acupuncture for depression and to discuss its impact on the content of 5-HT in patients with depression .
-METHODS	Eighty patients with depression were randomly divided into an acupuncture group and a western medication group ,40 cases in each one .
-METHODS	Acupuncture was applied in the acupuncture group , Siman ( KI 14 ) , Shenshu ( BL 23 ) , Guanyuan ( CV 4 ) , Dazhui ( GV 14 ) , Yinlingquan ( SP 9 ) , Zusanli ( ST 36 ) , Taichong ( LR 3 ) , Yanglingquan ( GB 34 ) and Jingming ( BL 1 ) were selected , the intensive moxibustion was applied at G ( uanyuan ( CV 4 ) .
-METHODS	Fluoxetine was treated with oral administration in the western medication group .
-METHODS	The treatments of six weeks were required in each group .
-METHODS	The Hamilton depression rating scale ( HAMD ) was applied to evaluate efficacy and serum 5-HT was detected before and after treatment in the two groups .
-RESULTS	After treatment , the scores of HAMD were decreased obviously in the two groups compared with those before treatment ( scores in the acupuncture group : 24.48 0.28 vs 8.95 2.24 ; scores in the western medication group : 24.140.24 vs 10.291.30 ) , and the differences were statistically significant ( both P < 0.05 ) .
-RESULTS	Between the two groups , the scores of HAMD in the acupuncture group at the end of the lst ,2 nd ,4 th ,6 th weeks were superior to those in the western medication group ( all P < 0.05 ) .
-RESULTS	The content of serum 5-HT after treatment was increased markedly compared with that before treatment [ the content in the acupuncture group : ( 26.21 2.36 ) pg/mL vs ( 52.07 0.56 ) pg/mL , the content in the western medication group : ( 26.262.31 ) pg/mL vs ( 51.700.52 ) pg / mL , both P < 0.05 ] .
-RESULTS	But there was no statistic significance between the two groups ( P > 0.05 ) .
-CONCLUSIONS	The efficacy of acupuncture for depression is superior to that of western medication with fluoxetine .
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-###25961136
-BACKGROUND	Intermittent 3-month cyclic administration might optimize the anabolic potential of teriparatide ( TPTD ) .
-OBJECTIVE	To determine whether 3-month cyclical TPTD would produce a similar bone mineral density ( BMD ) response to daily therapy in treatment naive ( Rx-naive ) women and to confirm the results in alendronate ( ALN ) - treated ( ALN-Rx ) women over 24 months .
-METHODS	Subjects participated in a randomized open-label study for 2 years .
-METHODS	Osteoporosis clinical research center .
-METHODS	A total of 150 postmenopausal women with osteoporosis in two cohorts : 86 Rx-naive and 64 ALN-Rx .
-METHODS	Within cohorts , women were randomized to daily TPTD for 24 months or four 3-month TPTD cycles , each followed by 3 months off ( 12 mo total TPTD ) .
-RESULTS	BMD at 24 months .
-RESULTS	In Rx-naive women , BMD increased in the lumbar spine ( LS ) , total hip ( TH ) , trochanter ( Troch ) , and femoral neck ( FN ) in daily and cyclic groups ( within groups , P < .0002 , except cyclic FN , P = .13 ) .
-RESULTS	Increases were 2-fold greater in daily vs cyclic groups ( LS , 8.8 vs 4.8 % ; TH , 4.0 vs 2.1 % ; Troch , 5.6 vs 3.1 % ; and FN , 2.9 vs 1.2 % ; group differences , all P < .05 ) .
-RESULTS	In daily vs cyclic groups , radius BMD declined ( -4.2 vs -2.1 % , respectively ; both P < .01 ; group difference , P = .08 ) and total bone mineral increased modestly ( 1.4 % , P = .18 ; vs 1.5 % , P = .06 ; group difference , not significant ) .
-RESULTS	In ALN-Rx women , there were no group differences ( daily vs cyclic : LS , 7.5 and 6.0 % ; TH , 3 and 2.5 % ; Troch , 3.7 and 3.3 % ; FN , 3 and 1.5 % ; within groups , P < .003 ; except cyclic FN , P = .2 ) .
-RESULTS	In daily and cyclic groups , radius BMD decreased ( -0.7 % [ not significant ] and -1.4 % [ P < .05 ] , respectively ) , and total bone mineral increased 2.3 and 3 % ( both P < .001 ) .
-CONCLUSIONS	Cyclic TPTD over 2 years improves BMD similarly to daily treatment in women who remain on ALN , despite only 50 % of the TPTD dose .
-CONCLUSIONS	However , there does not appear to be a BMD advantage to cyclic administration in treatment-naive women for up to 24 months .
-
-###24909836
-OBJECTIVE	To report a trial protocol that evaluates the effectiveness of postnatal psychoeducation programme in improving maternal parental self-efficacy and social support and in reducing postnatal depression among primiparas .
-BACKGROUND	Primiparas encounter physical , psychosocial and newborn care challenges in the early postnatal period .
-BACKGROUND	However , primiparas do not receive adequate professional support after early discharge from hospitals , thus hindering their adaptation to new role as mothers and smooth transition to motherhood .
-BACKGROUND	Postnatal psychoeducation programmes have been shown to be effective in improving pregnant women 's health .
-BACKGROUND	However , there is a lack of theory-based , postnatal psychoeducation interventions for primiparas .
-METHODS	A randomized controlled trial of two-group pretest and repeated posttests is proposed .
-METHODS	The study will recruit a minimum of 114 primiparas on the day of discharge from a Singaporean public hospital ( protocol approved in May 2012 ) .
-METHODS	Eligible participants will be randomly allocated to either a control group ( receiving routine care ) or an experimental group ( receiving a postnatal psychoeducation programme besides routine care ) .
-METHODS	Outcome measures include maternal parental self-efficacy , social support and postnatal depression .
-METHODS	Data will be collected at baseline ( on the day of discharge ) , 6 and 12weeks postpartum .
-CONCLUSIONS	This will be the first study of its kind that will use rigorous study design to evaluate a theory-based innovative postnatal psychoeducation programme on maternal outcomes .
-CONCLUSIONS	The study may identify a potentially effective way of enhancing primiparas ' self-efficacy and social support , which may in turn reduce their risk of postnatal depression .
-CONCLUSIONS	The Sigma Theta Tau International Upsilon Eta Chapter funded this study .
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-###25232263
-OBJECTIVE	To examine the efficacy and safety of otilonium bromide ( OB ) in treatment-sensitive functional irritable bowel syndrome ( IBS ) clinical parameters .
-METHODS	Ninety-three patients ( 44.8 12.6 years , 69 % female ) with IBS symptoms complying with Rome II criteria participated in this double-blind , placebo-controlled , randomised , dose-ranging phase I/II study .
-METHODS	Patients were administered OB 20 mg ( n = 24 ) , 40 mg ( n = 23 ) and 80 mg ( n = 23 ) tid or placebo ( n = 23 ) in 4 parallel groups for 4 wk .
-METHODS	Primary efficacy variables included abdominal discomfort , intestinal habits , number of daily evacuations and stool consistency .
-METHODS	Secondary efficacy measures included return to regular intestinal habits and global discomfort .
-METHODS	Safety was also assessed .
-RESULTS	Baseline clinical characteristics were similar among the 4 groups .
-RESULTS	Although individual parameters such as intensity and frequency of abdominal discomfort , bloating or pain were reduced by OB over the 4 wk , no significant differences were observed between groups .
-RESULTS	Similarly , no difference was observed between OB treatment or placebo for mucus in stool and incomplete or difficulty of evacuation .
-RESULTS	However , evacuation frequency was significantly reduced after 4 wk by 80 mg OB compared to placebo ( -8.36 % for placebo vs -41.9 % for 80 mg OB , P < 0.01 ) .
-RESULTS	While 21.7 % of patients in the placebo group experienced regular intestinal habits after 4 wk , this improvement was greater for patients treated with 40 mg OB ( P < 0.01 vs placebo ) .
-RESULTS	Furthermore , a dose-dependent reduction in frequency of diarrhoea ( ( 2 ) - test for trend = 11.5 , P < 0.001 ) and an increase in normal stool frequency was observed .
-RESULTS	Combining individual variables into a global discomfort index revealed significant improvement among increasing OB doses , favouring 40 mg ( P = 0.013 ) and 80 mg OB ( P = 0.001 ) over placebo .
-RESULTS	No difference was observed between frequency of adverse events for placebo vs OB .
-CONCLUSIONS	This dose-ranging study demonstrates that OB at 40 and 80 mg can improve individual and global clinical symptoms of IBS compared to placebo over a 4-wk period .
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-###25128068
-OBJECTIVE	Chronic hemorrhagic radiation proctopathy is not uncommon after radiotherapy for cervical carcinoma .
-OBJECTIVE	The outcomes of several treatments have been variable .
-OBJECTIVE	Many studies demonstrate that topical treatment with 4 % formalin is effective and safe .
-OBJECTIVE	However , a nonrandomized control study showed a high response rate and good tolerance in chronic radiation proctopathy patients treated with 10 % formalin .
-OBJECTIVE	The optimal concentration of formalin therefore remains unclear .
-METHODS	To compare the effectiveness and safety of 4 and 10 % formalin for the treatment of chronic hemorrhagic radiation proctopathy , a prospective trial was conducted at the Department of Gynecology of the Affiliated Hospital of Binzhou Medical College from January 2009 to December 2012 .
-METHODS	One hundred and twenty patients with chronic hemorrhagic radiation proctopathy following radiotherapy for cervical carcinoma were recruited and randomized to receive 4 or 10 % formalin .
-METHODS	A standard protocol was followed for formalin application .
-METHODS	Symptom and rectoscopy scores were evaluated before and at 12 weeks after treatment .
-RESULTS	In the 4 % formalin group , 49 ( 86.0 % ) and 53 ( 91.4 % ) patients showed an improvement in symptom score and rectoscopy score , respectively ( P = 0.36 ) .
-RESULTS	Symptom and rectoscopy scores decreased significantly after treatment in both the 4 % formalin group and the 10 % formalin group ( P < 0.001 ) .
-RESULTS	Symptom score was correlated with rectoscopy score ( P < 0.001 ) .
-RESULTS	More patients in the 10 % group suffered treatment-related complications than did those in the 4 % group ( P = 0.03 ) .
-CONCLUSIONS	For the treatment of chronic hemorrhagic radiation proctopathy , 4 % should be the preferred formalin concentration .
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-###24515352
-BACKGROUND	Erythropoietin ( EPO ) derivatives have been found to increase frataxin levels in Friedreich 's ataxia ( FRDA ) in vitro .
-BACKGROUND	This multicenter , double-blind , placebo-controlled , phase II clinical trial aimed to evaluate the safety and tolerability of Lu AA24493 ( carbamylated EPO ; CEPO ) .
-METHODS	Thirty-six ambulatory FRDA patients harboring > 400 GAA repeats were 2:1 randomly assigned to either CEPO in a fixed dose ( 325 g thrice-weekly ) or placebo .
-METHODS	Safety and tolerability were assessed up to 103 days after baseline .
-METHODS	Secondary outcome measures of efficacy ( exploration of biomarkers and ataxia ratings ) were performed up to 43 days after baseline .
-RESULTS	All patients received six doses of study medication .
-RESULTS	Adverse events were equally distributed between CEPO and placebo .
-RESULTS	There was no evidence for immunogenicity of CEPO after multiple dosing .
-RESULTS	Biomarkers , such as frataxin , or measures for oxidative stress and ataxia ratings did not differ between CEPO and placebo .
-CONCLUSIONS	CEPO was safe and well tolerated in a 2-week treatment phase .
-CONCLUSIONS	Secondary outcome measures remained without apparent difference between CEPO and placebo .
-
-###25259781
-BACKGROUND	School-based health centers ( SBHCs ) may be an ideal setting to address obesity in adolescents because they provide increased access to a traditionally difficult-to-reach population .
-BACKGROUND	The study evaluated the feasibility of adding a health educator ( HE ) to SBHC teams to provide support and increase the delivery of preventive services for overweight or obese adolescents .
-METHODS	Adolescents with BMI 85 % recruited from two SBHCs were randomized to a control group ( CG ) or an intervention group ( IG ) .
-METHODS	Both groups received preventive services , including physical examinations and laboratory screening in the SBHC .
-METHODS	The educator met with the IG during the academic year , utilizing motivational interviewing techniques to set lifestyle goals .
-METHODS	Text messaging was used to reinforce goals between visits .
-RESULTS	Eighty-two students ( 15.71.5 years of age ; BMI , 31.96.2 kg/m ( 2 ) ) were enrolled in the IG and 83 in the control group ( 16.01.5 years of age ; BMI , 31.66.5 kg/m ( 2 ) ) .
-RESULTS	Retention was 94 % in the IG and 87 % in the CG .
-RESULTS	A total of 54.5 % of the IG and 72.2 % of the CG decreased or maintained BMI z-score ( less than 0.05 increase ; p = 0.025 ) .
-RESULTS	Sports participation was higher in the CG ( 47 % vs. 28 % in the IG ; p = 0.02 ) .
-RESULTS	Mean BMI z-score change was -0.050.2 for students participating in sports vs. 0.010.2 for those not ( p = 0.09 ) .
-CONCLUSIONS	This SBHC intervention showed successful recruitment and retention of participants and delivery of preventive services in both groups .
-CONCLUSIONS	Meeting with an HE did not improve BMI outcomes in the IG .
-CONCLUSIONS	Confounding factors , including sports participation and SBHC utilization , likely contributed to BMI outcomes .
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-###24907502
-OBJECTIVE	No treatment has been approved by the U.S. Food and Drug Administration for eosinophilic esophagitis ( EoE ) .
-OBJECTIVE	We investigated the efficacy and safety of a new formulation of oral budesonide suspension ( OBS ) , a corticosteroid , in a prospective , placebo-controlled , dose-ranging study .
-METHODS	Subjects 2-18 years old with symptoms of EoE and peak eosinophil counts 20/high-power field at 2 levels of the esophagus were randomly assigned to groups given placebo or low-dose , medium-dose , or high-dose OBS for 12 weeks .
-METHODS	Doses and volumes were adjusted on the basis of patients ' age to cover the entire esophagus .
-METHODS	The primary efficacy end point was compound response to therapy ( peak eosinophil counts 6/high-power field at all levels of the esophagus and 50 % reduction in EoE symptom score ) .
-METHODS	Multiple safety parameters were evaluated .
-RESULTS	Data from 71 subjects who completed all efficacy assessments were included in the primary efficacy analysis .
-RESULTS	At the end of 12 weeks , there were significantly greater percentages of responders in groups given medium-dose OBS ( 52.6 % , P = .0092 ) and high-dose OBS ( 47.1 % , P = .0174 ) than in the group given placebo ( 5.6 % ) ; there was no significant difference in percentages of responders between the low-dose OBS ( 11.8 % ) and placebo groups ( P = .5282 ) .
-RESULTS	The significant compound responses noted in the medium-dose and high-dose OBS groups were accounted for by the significant histologic responses ; in contrast , all 4 groups ( including the placebo group ) had large symptom responses , and there was no significant difference in the percentage of subjects with a symptom response in either OBS group compared with the placebo group ( P .1235 ) .
-RESULTS	There were no unexpected safety concerns or signals .
-CONCLUSIONS	Peak eosinophil counts were significantly reduced throughout the esophagus in pediatric patients with EoE who were given medium-dose and high-dose OBS .
-CONCLUSIONS	There was a large symptom response to placebo that was similar to symptom responses in the OBS groups ; symptom response did not distinguish OBS from placebo .
-CONCLUSIONS	ClinicalTrials.gov number , NCT00762073 .
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-###24740207
-BACKGROUND	Vitamin D status may influence a spectrum of health outcomes , including osteoporosis , arthritis , cardiovascular disease , and cancer .
-BACKGROUND	Vitamin D-binding protein ( DBP ) is the primary carrier of vitamin D in the circulation and regulates the bioavailability of 25-hydroxyvitamin D. Epidemiologic studies have shown direct DBP-risk relations and modification by DBP of vitamin D-disease associations .
-OBJECTIVE	We aimed to characterize common genetic variants that influence the DBP biochemical phenotype .
-METHODS	We conducted a genome-wide association study ( GWAS ) of 1380 men through linear regression of single-nucleotide polymorphisms ( SNPs ) in the Illumina HumanHap500/550/610 array on fasting serum DBP , assuming an additive genetic model , with adjustment for age at blood collection .
-RESULTS	We identified 2 independent SNPs located in the gene encoding DBP , GC , that were highly associated with serum DBP : rs7041 ( P = 1.42 10 ) and rs705117 ( P = 4.7 10 ) .
-RESULTS	For both SNPs , mean serum DBP decreased with increasing copies of the minor allele : mean DBP concentrations ( nmol/L ) were 7335 , 5149 , and 3152 for 0 , 1 , and 2 copies of rs7041 ( T ) , respectively , and 6339 , 4280 , and 2341 , respectively , for rs705117 ( G ) .
-RESULTS	DBP was also associated with rs12144344 ( P = 5.9 10 ) in ST6GALNAC3 .
-CONCLUSIONS	In this GWAS analysis , to our knowledge the first to examine this biochemical phenotype , 2 variants in GC -- one exonic and one intronic -- were associated with serum DBP concentrations at the genome-wide level of significance .
-CONCLUSIONS	Understanding the genetic contributions to circulating DBP may provide greater insights into the vitamin D binding , transport , and other functions of DBP and the effect of vitamin D status on health outcomes .
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-###24285457
-BACKGROUND	In this study we tried to assess the efficacy of topical emollients in the treatment of patients with PUVA-induced pruritus .
-METHODS	41 patients over 18 years of age , who received PUVA treatment in the phototherapy unit , were included in the study .
-METHODS	Patients were randomly divided into two groups ; Group I was administered with a 4 % urea lotion and Group II was administered with liquid petrolatum .
-METHODS	The follow-up period was minimum 4 weeks .
-METHODS	During the first 2 weeks , patients were administered topical emollients and received PUVA treatment together .
-METHODS	The next 2 weeks , they continued PUVA treatment without any medication .
-RESULTS	When time-dependent changes in the visual analogue scale scores for pruritus of both groups were considered , both treatment methods were found to be remarkably successful ( p < 0.0001 ) .
-RESULTS	In addition , an insignificant group-time interaction was identified ( p = 0.753 ) .
-CONCLUSIONS	Topical emollients were found to be effective in the treatment of PUVA-induced pruritus .
-CONCLUSIONS	Both forms of medication can be successfully administered and increase the patient 's compliance with medication .
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-###26063762
-BACKGROUND	Hypertension control rates remain suboptimal .
-BACKGROUND	Pharmacists ' scope of practice is evolving , and their position in the community may be ideal for improving hypertension care .
-BACKGROUND	We aimed to study the impact of pharmacist prescribing on blood pressure ( BP ) control in community-dwelling patients .
-RESULTS	We designed a patient-level , randomized , controlled trial , enrolling adults with above-target BP ( as defined by Canadian guidelines ) through community pharmacies , hospitals , or primary care teams in 23 communities in Alberta .
-RESULTS	Intervention group patients received an assessment of BP and cardiovascular risk , education on hypertension , prescribing of antihypertensive medications , laboratory monitoring , and monthly follow-up visits for 6 months ( all by their pharmacist ) .
-RESULTS	Control group patients received a wallet card for BP recording , written hypertension information , and usual care from their pharmacist and physician .
-RESULTS	Primary outcome was the change in systolic BP at 6 months .
-RESULTS	A total of 248 patients ( mean age , 64 years ; 49 % male ) were enrolled .
-RESULTS	Baseline meanSD systolic/diastolic BP was 15014/8411 mm Hg .
-RESULTS	The intervention group had a meanSE reduction in systolic BP at 6 months of 18.31.2 compared with 11.81.9 mm Hg in the control group , an adjusted difference of 6.61.9 mm Hg ( P = 0.0006 ) .
-RESULTS	The adjusted odds of patients achieving BP targets was 2.32 ( 95 % confidence interval , 1.17-4 .15 in favor of the intervention ) .
-CONCLUSIONS	Pharmacist prescribing for patients with hypertension resulted in a clinically important and statistically significant reduction in BP .
-CONCLUSIONS	Policy makers should consider an expanded role for pharmacists , including prescribing , to address the burden of hypertension .
-BACKGROUND	URL : http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00878566 .
-
-###24987970
-OBJECTIVE	This prospective study was done to evaluate the efficacy of commercial fibrin glue application in the healing of patients with fistulas-in-ano from a short follow up period ( one year ) .
-METHODS	This randomized clinical trial of 26 patients was performed during the period from January 2012 to July 2012 .
-METHODS	Nineteen men and seven women were treated for a fistula-in-ano with a commercial fibrin glue injection .
-METHODS	In the operating room , the patients underwent an anorectal examination under spinal anesthesia .
-METHODS	The external and internal fistula tract openings were then identified and the fistula tract was accurately curetted .
-METHODS	Fibrin glue was introduced by a loaded double-channel syringe into the external fistula opening until the fibrin glue tip could be seen emerging from the internal opening .
-RESULTS	The initial success rate was 76.9 % ( 20/26 ) .
-RESULTS	Recurrence rate was 23 % ( 6/26 ) .
-RESULTS	Four patients underwent a re-application of fibrin glue and the fistulas of these patients closed .
-RESULTS	Total recurrence rate was 7.6 % ( 2/26 ) .
-RESULTS	The overall success rate was 69.2 % ( 18/26 ) .
-CONCLUSIONS	Fibrin glue application was thus found to be an easy , safe , successful alternative treatment in the management of fistulas-in-ano .
-CONCLUSIONS	Specifically , this therapeutic option demonstrated his efficacy for simple non-ramificated transsphincteric and intersphincteric fistulas .
-CONCLUSIONS	Multicentric randomized clinical trials with more representative sample seem to be necessary to investigate the best patients to treat by fibrin glue injection and the optimal application technique to improve these results .
-
-###25608899
-OBJECTIVE	To investigate the efficacy of mouse nerve growth factor ( mNGF ) in treating occupational hand-arm vibration disease ( HAVD ) .
-METHODS	Sixty-four patients with HAVD were equally and randomly divided into treatment group and control group .
-METHODS	The control group was given Salvia miltiorrhiza Bunge and deproteinized extract of calf blood to improve circulation , and also given methylcobalamin tablets and vitamin B6 for neurotrophic treatment .
-METHODS	In addition to the above treatments for the control group , the treatment group was also given 30 g/d mNGF by intramuscular injection for two courses ( 4 weeks for each course ) with a 15-day interval .
-RESULTS	Both the treatment group and the control group showed significant improvements in clinical symptoms and signs ( hand numbness and pain , and reduced senses of touch , pain , and vibration ) , cold water loading test ( CWLT ) , and electroneuromyography ( ENMG ) after treatments ( P < 0.05 ) .
-RESULTS	And the treatment group had significantly more improvements than the control group ( P < 0.05 ) .
-CONCLUSIONS	mNGF can significantly improve hand numbness and pain , reduced senses of touch , pain , and vibration , CWLT , and ENMG , so it has better clinical effect and safety in treating HAVD .
-CONCLUSIONS	Early diagnosis and treatment can improve the outcome of patients with HAVD .
-
-###24925713
-OBJECTIVE	To test if docosahexaenoic acid-enriched fish oil supplementation rectifies red cell membrane lipid anomaly in pregnant women with Type2 diabetes and their neonates , and alters fetal body composition .
-METHODS	Women with Type2 diabetes ( n = 88 ; 41 fish oil , 47 placebo ) and healthy women ( n = 85 ; 45 fish oil , 40 placebo ) were supplemented from the first trimester until delivery .
-METHODS	Blood fatty acid composition , fetal biometric and neonatal anthropometric measurements were assessed .
-RESULTS	A total of 117 women completed the trial .
-RESULTS	The women with Type2 diabetes who took fish oil compared with those who received placebo had higher percentage of docosahexaenoic acid in red cell phosphatidylethanolamine in the third trimester ( 12.0 % vs. 8.9 % , P = 0.000 ) and at delivery ( 10.7 % vs. 7.4 % , P = 0.001 ) .
-RESULTS	Similarly , the neonates of the women with Type2 diabetes supplemented with the fish oil had increased docosahexaenoic acid in the red cell phosphatidylethanolamine ( 9.2 % vs. 7.7 % , P = 0.027 ) and plasma phosphatidylcholine ( 6.1 % vs. 4.7 % , P = 0.020 ) .
-RESULTS	Docosahexaenoic acid-rich fish oil had no effect on the body composition of the fetus and neonates of the women with Type2 diabetes .
-CONCLUSIONS	A daily dose of 600mg of docosahexaenoic acid was effective in ameliorating red cell membrane docosahexaenoic acid anomaly in pregnant women with Type2 diabetes and neonates , and in preventing the decline of maternal docosahexaenoic acid during pregnancy .
-CONCLUSIONS	We suggest that the provision of docosahexaenoic acid supplement should be integrated in the antenatal care of pregnant women with Type2 diabetes .
-
-###24980650
-BACKGROUND	Type 2 diabetes is a major health problem in many countries including India .
-BACKGROUND	Yoga may be an effective type 2 diabetes prevention strategy in India , particularly given its cultural familiarity .
-METHODS	This was a parallel , randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes .
-METHODS	Primary outcomes included : changes in BMI , waist circumference , fasting blood glucose , postprandial blood glucose , insulin , insulin resistance , blood pressure , and cholesterol .
-METHODS	We also looked at measures of psychological well-being including changes in depression , anxiety , positive and negative affect and perceived stress .
-METHODS	Forty-one participants with elevated fasting blood glucose in Bangalore , India were randomized to either yoga ( n = 21 ) or a walking control ( n = 20 ) .
-METHODS	Participants were asked to either attend yoga classes or complete monitored walking 3-6 days per week for eight weeks .
-METHODS	Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed , opaque envelopes generated by off-site study staff .
-METHODS	Data were analyzed based on intention to treat .
-RESULTS	This study was feasible in terms of recruitment , retention and adherence .
-RESULTS	In addition , yoga participants had significantly greater reductions in weight , waist circumference and BMI versus control ( weight -0.82.1 vs. 1.43.6 , p = 0.02 ; waist circumference -4.24.8 vs. 0.74.2 , p < 0.01 ; BMI -0.20.8 vs. 0.61.6 , p = 0.05 ) .
-RESULTS	There were no between group differences in fasting blood glucose , postprandial blood glucose , insulin resistance or any other factors related to diabetes risk or psychological well-being .
-RESULTS	There were significant reductions in systolic and diastolic blood pressure , total cholesterol , anxiety , depression , negative affect and perceived stress in both the yoga intervention and walking control over the course of the study .
-CONCLUSIONS	Among Indians with elevated fasting blood glucose , we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control .
-CONCLUSIONS	Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being .
-BACKGROUND	ClinicalTrials.gov Identified NCT00090506 .
-
-###25533442
-OBJECTIVE	To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse .
-METHODS	Randomised controlled trial .
-METHODS	Dutch primary care .
-METHODS	Women aged 55 years or over with symptomatic mild prolapse ( leading edge above the hymen ) were identified by screening .
-METHODS	Exclusion criteria were current prolapse treatment or treatment in the previous year , malignancy of pelvic organs , current treatment for another gynaecological disorder , severe/terminal illness , impaired mobility , cognitive impairment , and insufficient command of the Dutch language .
-METHODS	Pelvic floor muscle training versus watchful waiting .
-METHODS	The primary outcome was change in bladder , bowel , and pelvic floor symptoms measured with the Pelvic Floor Distress Inventory-20 ( PFDI-20 ) , three months after the start of treatment .
-METHODS	Secondary outcomes were changes in condition specific and general quality of life , sexual function , degree of prolapse , pelvic floor muscle function , and patients ' perceived change in symptoms .
-RESULTS	Of the 287 women who were randomised to pelvic floor muscle training ( n = 145 ) or watchful waiting ( n = 142 ) , 250 ( 87 % ) completed follow-up .
-RESULTS	Participants in the intervention group improved by ( on average ) 9.1 ( 95 % confidence interval 2.8 to 15.4 ) points more on the PFDI-20 than did participants in the watchful waiting group ( P = 0.005 ) .
-RESULTS	Of women in the pelvic floor muscle training group , 57 % ( 82/145 ) reported an improvement in overall symptoms from the start of the study compared with 13 % ( 18/142 ) in the watchful waiting group ( P < 0.001 ) .
-RESULTS	Other secondary outcomes showed no significant difference between the groups .
-CONCLUSIONS	Although pelvic floor muscle training led to a significantly greater improvement in PFDI-20 score , the difference between the groups was below the presumed level of clinical relevance ( 15 points ) .
-CONCLUSIONS	Nevertheless , 57 % of the participants in the intervention group reported an improvement of overall symptoms .
-CONCLUSIONS	More studies are needed to identify factors related to success of pelvic floor muscle training and to investigate long term effects.Trial registration Dutch Trial Register ( www.trialregister.nl ) identifier : NTR2047 .
-
-###26227101
-OBJECTIVE	Two single-center , four-way , single-dose , crossover studies assessed the systemic exposure , systemic pharmacodynamics ( PD ) , and safety profile of the closed triple fluticasone furoate / umeclidinium/vilanterol ( FF/UMEC/VI ) therapy compared with dual therapies .
-OBJECTIVE	These are the first studies where pharmacokinetic ( PK ) profile assessment was possible for this inhaled triple fixed-dose combination product .
-METHODS	Healthy volunteers were randomized to receive 4 consecutive inhalations ( each administered as a single dose ) via a single ELLIPT dry powder inhaler : in study 1 ( CTT116415/NCT01691547 ) , FF/UMEC/VI at total doses of 400/500/100 g , FF/UMEC 400/500 g , UMEC/VI 500/100 g , or FF/VI 400/100 g ; in study 2 ( 200587/NCT01894386 ) , FF/UMEC/VI at total doses of 400/500/100 g or 400/250/100 g , FF/VI 400/100 g , or UMEC/VI 250/100 g. PK and PD parameters and safety were assessed .
-RESULTS	Of 88 subjects , 95 % completed both studies and received all planned treatments .
-RESULTS	Total systemic exposure was similar for FF , UMEC , and VI when administered as a triple therapy compared with FF/VI and UMEC/VI .
-RESULTS	No clinically significant systemic PD findings were detected .
-RESULTS	The incidence of adverse events was low and similar across treatment arms .
-CONCLUSIONS	Systemic exposure to all three components of the closed triple therapy , following single-dose delivery , was similar to that seen with the dual therapies FF/VI and UMEC/VI .
-CONCLUSIONS	The delivered lung dose and safety profile of all three agents , delivered via a single inhaler , are expected to be similar to those of the dual therapies .
-
-###24528484
-BACKGROUND	The Coping with Persistent Pain , Effectiveness Research into Self-management ( COPERS ) trial assessed whether a group-based self-management course is effective in reducing pain-related disability in participants with chronic musculoskeletal pain .
-BACKGROUND	This article describes the statistical analysis plan for the COPERS trial .
-METHODS	COPERS was a pragmatic , multicentre , unmasked , parallel group , randomised controlled trial .
-METHODS	This article describes ( a ) the overall analysis principles ( including which participants will be included in each analysis , how results will be presented , which covariates will be adjusted for , and how we will account for clustering in the intervention group ) ; ( b ) the primary and secondary outcomes , and how each outcome will be analysed ; ( c ) sensitivity analyses ; ( d ) subgroup analyses ; and ( e ) adherence-adjusted analyses .
-BACKGROUND	ISRCTN24426731 .
-
-###24928338
-BACKGROUND	Current maintenance therapies for asthma require twice-daily dosing .
-BACKGROUND	Vilanterol ( VI ) is a novel long-acting beta2 agonist , under development in combination with fluticasone furoate , a new inhaled corticosteroid ( ICS ) .
-BACKGROUND	Findings from a previous 4-week study suggested that VI has inherent 24-hour activity and is therefore suitable for once-daily dosing .
-BACKGROUND	The study described here was a double-blind , double-dummy , randomised , placebo-controlled trial , the aim of which was to assess the efficacy of once-daily VI compared with placebo in patients with persistent asthma .
-BACKGROUND	The primary endpoint was change from baseline in 24-hour weighted mean forced expiratory volume in 1second after 12weeks of treatment vs. placebo .
-BACKGROUND	An active control arm received salmeterol ( SAL ) twice daily .
-BACKGROUND	All patients were maintained on a stable background dose of ICS .
-RESULTS	Patients ( n = 347 ) received VI , placebo or SAL ( 1:1:1 ) .
-RESULTS	For the primary endpoint , substantial improvements in lung function were seen with VI ( 359ml ) , SAL ( 283ml ) and placebo ( 289ml ) .
-RESULTS	There were no statistically significant treatment differences between either the VI ( 70ml , P = 0.244 ) or SAL ( -6 ml , P = 0.926 ) groups and placebo .
-RESULTS	Both active treatments were well tolerated , with similarly low rates of treatment-related adverse events compared with placebo .
-RESULTS	No treatment-related serious adverse events occurred .
-CONCLUSIONS	This study failed to show a treatment difference between VI and placebo for the primary endpoint , in the presence of a placebo response of unforeseen magnitude .
-CONCLUSIONS	Because the placebo response was so large , it is not possible to draw meaningful conclusions from the data .
-CONCLUSIONS	The reason for this magnitude of effect is unclear but it may reflect increased compliance with the anti-inflammatory therapy regimen during the treatment period .
-BACKGROUND	NCT01181895 at ClinicalTrials.gov .
-
-###25656375
-OBJECTIVE	The randomized , double-blinded , placebo-controlled study evaluated the administration of local infiltration of magnesium combined with ropivacaine to reduce pain scores after pediatric adenotonsillectomy .
-METHODS	Sixty one subjects received 5ml solution contained 0.25 % ropivacaine plus 5mg/kg magnesium sulphate ( Group M+R ) , 5ml 0.25 % ropivacaine ( Group R ) or 5ml solution contained 5mg/kg magnesium sulphate ( Group M ) .
-METHODS	Pain scores in the ward and at home , analgesics received after operation and the adverse effects were recorded .
-RESULTS	Compared with group M , patients in group M+R and group R had lower pain scores , less emergence agitation and increased time for first analgesic request .
-RESULTS	Group M+R had no benefit in reducing pain scores after adenotonsillectomy compared with group R.
-CONCLUSIONS	Pre-emptive peritonsillar infiltration of magnesium sulphate 5mg/kg combined with 0.25 % ropivacaine could n't improve analgesia for pediatric adenotonsillectomy compared with 0.25 % ropivacaine alone .
-CONCLUSIONS	However , Group M+R had less incidence of emergence agitation .
-CONCLUSIONS	Compared with group M , both of group M+R and group R had better postoperative analgesia .
-
-###24522441
-BACKGROUND	Dietary determinants of hepatic steatosis , an important precursor for nonalcoholic fatty liver disease , are undefined .
-OBJECTIVE	We explored the roles of sugar and fat intake as determinants of hepatic steatosis and visceral obesity in overweight adolescents at risk of type 2 diabetes .
-METHODS	This was a cross-sectional study of dietary patterns and adipose tissue distribution in 74 overweight adolescents ( aged : 15.4 1.8 y ; body mass index z score : 2.2 0.4 ) .
-METHODS	Main outcome measures were hepatic steatosis ( 5.5 % fat : water ) measured by magnetic resonance spectroscopy and visceral obesity ( visceral-to-subcutaneous adipose tissue ratio 0.25 ) measured by magnetic resonance imaging .
-METHODS	Main exposure variables were dietary intake and habits assessed by the Harvard Youth Adolescent Food Frequency Questionnaire .
-RESULTS	Hepatic steatosis and visceral obesity were evident in 43 % and 44 % of the sample , respectively .
-RESULTS	Fried food consumption was more common in adolescents with hepatic steatosis than in adolescents without hepatic steatosis ( 41 % compared with 18 % ; P = 0.04 ) .
-RESULTS	Total fat intake ( = 0.51 , P = 0.03 ) and the consumption of > 35 % of daily energy intake from fat ( OR : 11.8 ; 95 % CI : 1.6 , 86.6 ; P = 0.02 ) were both positively associated with hepatic steatosis .
-RESULTS	Available carbohydrate ( = 0.54 , P = 0.02 ) and the frequent consumption of soda were positively associated with visceral obesity ( OR : 6.4 ; 95 % CI : 1.2 , 34.0 ; P = 0.03 ) .
-RESULTS	Daily fiber intake was associated with reduced odds of visceral obesity ( OR : 0.82 ; 95 % CI : 0.68 , 0.98 ; P = 0.02 ) but not hepatic steatosis .
-CONCLUSIONS	Hepatic steatosis is associated with a greater intake of fat and fried foods , whereas visceral obesity is associated with increased consumption of sugar and reduced consumption of fiber in overweight and obese adolescents at risk of type 2 diabetes .
-
-###24857519
-OBJECTIVE	To determine whether additional supplementation of tryptophan ( Trp ) and tyrosine ( Tyr ) improve serotonin and dopamine metabolism in individuals with phenylketonuria treated with large neutral amino acid ( LNAA ) tablets .
-METHODS	Ten adult individuals with phenylketonuria participated in a randomized , double-blind , placebo-controlled cross-over study consisting of three 3-week phases : washout , treatment with LNAA tablets plus supplementation with either Trp and Tyr tablets or placebo , and LNAA tablets plus the alternate supplementation .
-METHODS	An overnight protocol to measure blood melatonin , a serotonin metabolite in the pinealocytes , and urine 6-sulfatoxymelatonin and dopamine in first-void urine specimens was conducted after each phase .
-RESULTS	Serum melatonin and urine 6-sulfatoxymelatonin and dopamine levels were increased in the LNAA phase ( LNAA plus placebo ) compared with the washout phase .
-RESULTS	Serum melatonin and urine 6-sulfatoxymelatonin were not increased in the active phase ( LNAA plus Trp + Tyr ) compared with the LNAA phase , although plasma Trp : LNAA was increased compared with the LNAA phase .
-RESULTS	Among 7 subjects with a plasma Trp/LNAA > 0.03 , a negative correlation between urine 6-sulfatoxymelatonin and plasma phenylalanine levels was observed ( r = -0.072 ) .
-RESULTS	Urine dopamine levels and plasma Tyr : LNAA were increased in the active phase compared with the LNAA phase .
-CONCLUSIONS	Melatonin levels were not increased with the higher dose of Trp supplementation , but dopamine levels were increased with the higher dose of Tyr supplementation .
-CONCLUSIONS	Serotonin synthesis appears to be suppressed by high phenylalanine levels at the Trp hydroxylase level .
-
-###24442226
-BACKGROUND	In HIV-1-infected women , CD4 count declines occur during pregnancy , which has been attributed to hemodilution .
-BACKGROUND	However , for women who have not initiated antiretroviral therapy , it is unclear if CD4 declines are sustained beyond pregnancy and accompanied by increased viral levels , which could indicate an effect of pregnancy on accelerating HIV-1 disease progression .
-METHODS	In a prospective study among 2269 HIV-1-infected antiretroviral therapy-naive women from 7 African countries , we examined the effect of pregnancy on HIV-1 disease progression .
-METHODS	We used linear mixed models to compare CD4 counts and plasma HIV-1 RNA concentrations between pregnant , postpartum , and nonpregnant periods .
-RESULTS	Women contributed 3270 person-years of follow-up , during which time 476 women became pregnant .
-RESULTS	In adjusted analysis , CD4 counts were an average of 56 ( 95 % confidence interval : 39 to 73 ) cells/mm lower during pregnant compared with nonpregnant periods and 70 ( 95 % confidence interval : 53 to 88 ) cells/mm lower during pregnant compared with postpartum periods ; these results were consistent when restricted to the subgroup of women who became pregnant .
-RESULTS	Plasma HIV-1 RNA concentrations were not different between pregnant and nonpregnant periods ( P = 0.9 ) or pregnant and postpartum periods ( P = 0.3 ) .
-RESULTS	Neither CD4 counts nor plasma HIV-1 RNA levels were significantly different in postpartum compared with nonpregnant periods .
-CONCLUSIONS	CD4 count declines among HIV-1-infected women during pregnancy are temporary and not sustained in postpartum periods .
-CONCLUSIONS	Pregnancy does not have a short-term impact on plasma HIV-1 RNA concentrations .
-
-###24983279
-OBJECTIVE	To assess the efficacy of surgical decompression < 24 ( early ) versus 24-72 hours ( late ) in thoracic/thoracolumbar traumatic spinal cord injury ( TSCI ) .
-METHODS	A randomized controlled trial ( RCT ) of 35 T1-L1 TSCI patients including early ( n = 16 ) and late ( n = 19 ) surgical decompression was conducted in the neurosurgery department of Shahid Rajaee Hospital from September 2010 .
-METHODS	Pre - and postoperative American Spinal Injury Association ( ASIA ) Impairment Scale ( AIS ) , ASIA motor/sensory scores , length of hospitalization , complications , postoperative vertebral height restoration/rebuilding and angle reduction , and 12-month loss of height restoration/rebuilding and angle reduction were evaluated .
-RESULTS	Sixteen patients ( 46 % ) had complete TSCI .
-RESULTS	No AIS change was seen in 17 ( 52 % ) patients .
-RESULTS	Complete TSCI patients had no motor improvement .
-RESULTS	The AIS change in this group was solely due to increased sensory scores .
-RESULTS	For incomplete TSCI , the mean motor score improved from 77 ( 22 ) to 92 ( 12 ) in early , and from 68 ( 22 ) to 82 ( 16 ) in late surgery .
-RESULTS	One deep vein thrombosis was observed in each group .
-RESULTS	There were 2 wound infections , one CSF leak , one case of meningitis , and one decubitus ulcer in the late surgery group .
-RESULTS	Six screw revisions were required .
-CONCLUSIONS	Our primary results show overall AIS and motor score improvement in both groups .
-CONCLUSIONS	Motor improvement was only observed in incomplete TSCI .
-CONCLUSIONS	Two-grade improvements in AIS were seen in 3 early , and one late surgery patient .
-
-###24635755
-OBJECTIVE	To compare visual outcomes and spectral-domain optical coherence tomography results following treatment with intravitreal ranibizumab ( IVR ) or IVR combined with intravitreal triamcinolone acetonide ( IVTA ) for macular edema ( ME ) secondary to central retinal vein occlusion ( CRVO ) .
-METHODS	This prospective , case-controlled study examined 57 eyes ( 57 patients ) with ME secondary to CRVO , which were treated with IVR ( 0.5 mg , n = 30 eyes ) or IVR ( 0.5 mg ) and IVTA ( 1mg , n = 27eyes ) as the initial therapy .
-METHODS	Further intravitreal treatment was administered as necessary .
-RESULTS	All 57 patients completed at least 6 months of follow-up .
-RESULTS	At baseline , mean ( standard error ) best-corrected visual acuity ( BCVA ) was 45.823.2 letters in the IVR group and 47.319.3 letters in the IVR+IVTA group ( p = 0.790 ) .
-RESULTS	Significant improvement in BCVA over baseline was observed in both groups at all six study visits ( IVR group : p = 0.0003 , 0.0001 , 0.0018 , 0.0145 , 0.0107 , 0.005 ; IVR+IVTA group : p = 0.0001 , 0.0001 , 0.0004 , 0.0068 , 0.0007 , 0.0002 ) , with no significant BCVA differences between groups .
-RESULTS	Significant reduction in mean central subfield thickness , compared with baseline , was also observed in both groups at all six study visits ( IVR group , p = 0.0001 ; IVR+IVTA group , p = 0.0001 ) , with no significant difference between groups in the magnitude of macular thickness reduction .
-RESULTS	The mean number of injections was significantly higher ( p = 0.0001 ) in the IVR group ( 4.230.56 ) than in the IVR+IVTA group ( 3.420.41 ) .
-CONCLUSIONS	Treating ME secondary to CRVO with IVR or IVR+IVTA had similar effects on central macular thickness and BCVA in patients with ME secondary to CRVO over a 6-month follow-up period .
-CONCLUSIONS	The mean number of intravitreal injections was higher in the IVR group than in the IVR+IVTA group .
-
-###25975558
-OBJECTIVE	To evaluate the effect of Zhenggan Tang decoction on serum levels of leptin , adiponectin and insulin resistance on liver cirrhosis induced by chronic hepatitis B.
-METHODS	Sixty-six patients were recruited and randomly assigned either to a control group or to an intervention group , with 35 cases in the treatment and 31 in the control group respectively .
-METHODS	Patients in the control group received inosine tablets and vitamin C treatment while patients in the treatment group were given Zhenggan Tang decoction additionally .
-METHODS	After 3 months of treatment , the serum levels of leptin and adiponectin were detected and the index of insulin resistance calculated .
-RESULTS	There were no significant difference between the serum levels of leptin , adiponectin and the index of insulin resistance seen in the control group before and after the treatment .
-RESULTS	Serum levels of leptin and adiponectin and the index of insulin resistance in treatment group were reduced significantly after the treatment ( P < 0.05 ) .
-RESULTS	There were significant difference in the serum levels of leptin and adiponectin between treat group and control group ( P < 0.05 ) .
-CONCLUSIONS	Zhenggan Tang decoction seemed to have reduced the serum levels of leptin , adiponectin and the index of insulin resistance among cirrhotic patients that induced by chronic hepatitis B.
-
-###25123549
-BACKGROUND	Evidence from the literature suggests diminished acetylsalicylic acid ( ASA ) treatment efficacy in type 2 diabetes ( DM2 ) .
-BACKGROUND	High on-aspirin platelet reactivity ( HAPR ) in DM2 has been linked to poor glycemic and lipid control .
-BACKGROUND	However , there are no consistent data on the association between HAPR and insulin resistance or adipose tissue metabolic activity .
-BACKGROUND	The aim of this study was to assess the relationship between laboratory response to ASA and metabolic control , insulin resistance and adipokines in DM2 .
-METHODS	A total of 186 DM2 patients treated with oral antidiabetic drugs and receiving 75 mg ASA daily were included in the analysis .
-METHODS	Response to ASA was assessed by measuring serum thromboxane B2 ( TXB2 ) concentration and expressed as quartiles of TXB2 level .
-METHODS	The achievement of treatment targets in terms of glycemic and lipid control , insulin resistance parameters ( including Homeostatic Model Assessment-Insulin Resistance , HOMA-IR , index ) , and serum concentrations of high-molecular weight ( HMW ) adiponectin , leptin and resistin , were evaluated in all patients .
-METHODS	Univariate and multivariate logistic regression analyses were performed to determine the predictive factors of serum TXB2 concentration above the upper quartile and above the median .
-RESULTS	Significant trends in age , body mass index ( BMI ) , HOMA-IR , HMW adiponectin concentration , C-reactive protein concentration and the frequency of achieving target triglyceride levels were observed across increasing quartiles of TXB2 .
-RESULTS	In a multivariate analysis , only younger age and higher BMI were independent predictors of TXB2 concentration above the upper quartile , while younger age and lower HMW adiponectin concentration were predictors of TXB2 concentration above the median .
-CONCLUSIONS	These results suggest that in DM2 , the most important predictor of HAPR is younger age .
-CONCLUSIONS	Younger DM2 patients may therefore require total daily ASA doses higher than 75 mg , preferably as a twice-daily regimen , to achieve full therapeutic effect .
-CONCLUSIONS	Higher BMI and lower HMW adiponectin concentration were also associated with less potent ASA effect .
-CONCLUSIONS	This is the first study to demonstrate an association of lower adiponectin concentration with higher serum TXB2 level in patients treated with ASA .
-
-###24764200
-BACKGROUND	The effects of escitalopram ( 10mg/d ) coadministration on plasma concentrations of aripiprazole and its active metabolite , dehydroaripiprazole , were studied in 13 Japanese psychiatric patients and compared with those of paroxetine ( 10mg/d ) coadministration .
-METHODS	The patients had received 6-24mg / d of aripiprazole for at least 2 weeks .
-METHODS	Patients were randomly allocated to one of 2 treatment sequences : paroxetine-escitalopram ( n = 6 ) or escitalopram-paroxetine ( n = 7 ) .
-METHODS	Each sequence consisted of two 2-week phases .
-METHODS	Plasma concentrations of aripiprazole and dehydroaripiprazole were measured using liquid chromatography with mass spectrometric detection .
-RESULTS	Plasma concentrations of aripiprazole and the sum of aripiprazole and dehydroaripiprazole during paroxetine coadministration were 1.7-fold ( 95 % confidence intervals [ CI ] , 1.3-2 .1 , p < 0.001 ) and 1.5-fold ( 95 % CI 1.2-1 .9 , p < 0.01 ) higher than those values before the coadministration .
-RESULTS	These values were not influenced by escitalopram coadministration ( 1.3-fold , 95 % CI 1.1-1 .5 and 1.3-fold , 95 % CI 1.0-1 .5 ) .
-RESULTS	Plasma dehydroaripiprazole concentrations remained constant during the study .
-CONCLUSIONS	The present study suggests that low doses of escitalopram can be safely coadministered with aripiprazole , at least from a pharmacokinetic point of view .
-
-###24565713
-BACKGROUND	Associations of inhaled corticosteroids ( ICS ) with bone mineral density ( BMD ) loss have not been characterized consistently .
-OBJECTIVE	This randomized , double-blind study assessed effects of mometasone furoate ( MF ) administered via dry powder inhaler on BMD of patients with persistent asthma .
-METHODS	Adults with mild-moderate persistent asthma who did not receive ICS for 3 months were randomized to MF 400 g once daily ( QD ) in the evening ( pm ) , MF 200 g QD pm , montelukast sodium ( ML ) 10 mg QD pm , or fluticasone propionate ( FP ) 250 g twice daily .
-METHODS	Included patients had 25-hydroxy vitamin D levels 15 ng/mL at baseline .
-METHODS	All the patients received calcium and vitamin D supplements for daily use during the trial .
-METHODS	Duplicate BMD scans were done at baseline , 6 months , and 1 year .
-METHODS	The mean percentage change in lumbar spine ( LS ) BMD from baseline to end point for MF 400 g versus ML 10 mg was the primary analysis .
-METHODS	Changes from baseline in left total femur BMD and femoral neck BMD were secondary assessments .
-RESULTS	At the end point , mean LS BMD increased 0.9 % ( MF 400 g ) , 1.2 % ( ML ) , 0.7 % ( MF 200 g ) , and 1.1 % ( FP ) , with no significant differences for MF 400 g versus ML ( -0.3 % [ 95 % CI , -1.01 to 0.27 ] ) for LS BMD .
-RESULTS	No significant differences among treatments occurred for changes in left total femur BMD ; all were slight increases .
-RESULTS	Changes in femoral neck BMD were 0.4 % ( MF 400 g ) , -0.2 % ( ML ) , -0.2 % ( MF 200 g ) , and -0.4 % ( FP ) ; only the difference between MF 400 g and FP was statistically significant ( P = .044 ) .
-CONCLUSIONS	No detrimental effects on lumbar BMD were observed after up to 1 year of treatment with MF in comparison with ML for patients who received calcium and vitamin D supplements .
-
-###24766732
-BACKGROUND	The efficacy and safety of axitinib , a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1 , 2 , and 3 in combination with pemetrexed and cisplatin was evaluated in patients with advanced non-squamous non-small-cell lung cancer ( NSCLC ) .
-METHODS	Overall , 170 patients were randomly assigned to receive axitinib at a starting dose of 5-mg twice daily continuously plus pemetrexed 500 mg/m ( 2 ) and cisplatin 75 mg/m ( 2 ) on day 1 of up to six 21-day cycles ( arm I ) ; axitinib on days 2 through 19 of each cycle plus pemetrexed/cisplatin ( arm II ) ; or pemetrexed/cisplatin alone ( arm III ) .
-METHODS	The primary endpoint was progression-free survival ( PFS ) .
-RESULTS	Median PFS was 8.0 , 7.9 , and 7.1 months in arms I , II , and III , respectively ( hazard ratio : arms I vs. III , 0.89 [ P = 0.36 ] and arms II vs. III , 1.02 [ P = 0.54 ] ) .
-RESULTS	Median overall survival was 17.0 months ( arm I ) , 14.7 months ( arm II ) , and 15.9 months ( arm III ) .
-RESULTS	Objective response rates ( ORRs ) for axitinib-containing arms were 45.5 % ( arm I ) and 39.7 % ( arm II ) compared with 26.3 % for pemetrexed/cisplatin alone ( arm III ) .
-RESULTS	Gastrointestinal disorders and fatigue were frequently reported across all treatment arms .
-RESULTS	The most common all-causality grade 3 adverse events were hypertension in axitinib-containing arms ( 20 % and 17 % , arms I and II , respectively ) and fatigue with pemetrexed/cisplatin alone ( 16 % ) .
-CONCLUSIONS	Axitinib in combination with pemetrexed/cisplatin was generally well tolerated .
-CONCLUSIONS	Axitinib combinations resulted in non-significant differences in PFS and numerically higher ORR compared with chemotherapy alone in advanced NSCLC .
-BACKGROUND	ClinicalTrials.gov : NCT00768755 ( October 7 , 2008 ) .
-
-###26271061
-BACKGROUND	The use of a balloon-expandable transcatheter heart valve previously resulted in a greater rate of device success compared with a self-expandable transcatheter heart valve .
-OBJECTIVE	The aim of this study was to evaluate clinical and echocardiographic outcome data at longer term follow-up .
-METHODS	The investigator-initiated trial randomized 241 high-risk patients with symptomatic severe aortic stenosis and anatomy suitable for treatment with both balloon - and self-expandable transcatheter heart valves to transfemoral transcatheter aortic valve replacement with either device .
-METHODS	Patients were followed-up for 1 year , with assessment of clinical outcomes and echocardiographic evaluation of valve function .
-RESULTS	At 1 year , the rates of death of any cause ( 17.4 % vs. 12.8 % ; relative risk [ RR ] : 1.35 ; 95 % confidence interval [ CI ] : 0.73 to 2.50 ; p = 0.37 ) and of cardiovascular causes ( 12.4 % vs. 9.4 % ; RR : 1.32 ; 95 % CI : 0.63 to 2.75 ; p = 0.54 ) were not statistically significantly different in the balloon - and self-expandable groups , respectively .
-RESULTS	The frequencies of all strokes ( 9.1 % vs. 3.4 % ; RR : 2.66 ; 95 % CI : 0.87 to 8.12 ; p = 0.11 ) and repeat hospitalization for heart failure ( 7.4 % vs. 12.8 % ; RR : 0.58 ; 95 % CI : 0.26 to 1.27 ; p = 0.19 ) did not statistically significantly differ between the 2 groups .
-RESULTS	Elevated transvalvular gradients during follow-up were observed in 4 patients in the balloon-expandable group ( 3.4 % vs. 0 % ; p = 0.12 ) ; all were resolved with anticoagulant therapy , suggesting a thrombotic etiology .
-RESULTS	More than mild paravalvular regurgitation was more frequent in the self-expandable group ( 1.1 % vs. 12.1 % ; p = 0.005 ) .
-CONCLUSIONS	Despite the higher device success rate with the balloon-expandable valve , 1-year follow-up of patients in CHOICE ( Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis : Medtronic CoreValve Versus Edwards SAPIEN XT Trial ) , with limited statistical power , revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with both balloon - and self-expandable prostheses that were not statistically significantly different .
-CONCLUSIONS	( A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis : The CHOICE Trial ; NCT01645202 ) .
-
-###24267123
-OBJECTIVE	We aimed to compare the effect and feasibility of a combined therapy with tamsulosin hydrochloride plus meloxicam , and tamsulosin hydrochloride alone in patients with benign prostate hyperplasia symptoms and impact on nocturia and sleep quality .
-METHODS	Four hundred male patients were included in this study between 2008 and 2011 .
-METHODS	Patients were randomly divided into two groups : one received tamsulosin hydrochloride 0.4 mg ( Group 1 , 200 patients ) and the other tamsulosin hydrochloride 0.4 mg plus meloxicam 15 mg ( Group 2 , 200 patients ) prospectively .
-METHODS	Patients were evaluated for benign prostate hyperplasia ( BPH ) symptoms according to the American Urological Association clinical guidelines and sleep quality according to Pittsburgh Sleep Quality Index ( PSQI ) .
-METHODS	Patients were reevaluated after three months of treatment .
-METHODS	The International Prostatic Symptom Score ( IPSS ) , IPSS-Quality of Life ( IPSS-QoL ) , maximal urinary flow rates ( Qmax ) , average urinary flow rates ( AFR ) , post void residual urine volumes ( PVR ) , nocturia and Pittsburgh Sleep Quality Score ( PSQS ) were recorded at baseline and after three months .
-RESULTS	Mean age was 63.3 6.6 and 61.4 7.5 years in groups 1 and 2 , respectively ( p = 0.245 ) .
-RESULTS	There were no statistically significant differences between both groups .
-RESULTS	Also , baseline prostate specific antigen ( PSA ) , prostate volume , creatinine , International Prostatic Symptom Score ( IPSS ) , IPSS-Quality of Life ( IPSS-QoL ) , maximal urinary flow rates ( Qmax ) , average urinary flow rates ( AFR ) , post void residual urine volumes ( PVR ) , nocturia and Pittsburgh Sleep Quality Score ( PSQS ) were similar in both groups .
-RESULTS	In addition , the total IPSS , IPSS-QoL , PVR , nocturia , and PSQS were significantly lower in Group 2 compared with Group 1 after treatment ( p < 0.05 ) .
-RESULTS	Qmax and AFR were higher significantly in Group 2 compared with Group 1 after treatment ( p < 0.05 ) .
-CONCLUSIONS	Cyclooxygenase ( COX ) -2 inhibitors in combination with an alpha blocker may decrease benign prostatic hyperplasia symptoms and increase sleep quality without serious side effects .
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-###25876640
-OBJECTIVE	To evaluate the efficacy and safety of patient-controlled intravenous analgesia ( PCIA ) of dezocine combined with sufentanil in burn patients after escharectomy or tangential excision followed by autologous skin grafting .
-METHODS	Sixty burn patients hospitalized in Department of Burns and Plastic Surgery of our hospital from February 2011 to December 2013 , conforming to the study criteria and going to have escharectomy or tangential excision followed by autologous skin grafting , were divided into sufentanil group ( S , n = 30 ) and dezocine + sufentanil group ( DS , n = 30 ) according to the random number table .
-METHODS	Patients in group S were given 150 mL normal saline containing 2.5 g/kg sufentanil citrate and 6 mg tropisetron after skin grafting for 48 hours .
-METHODS	Patients in group DS were given 150 mL normal saline containing 0.25 mg/kg dezocine , 1.5 g/kg sufentanil citrate , and 6 mg tropisetron for 48 hours .
-METHODS	Visual Analog Scale ( VAS ) , Bruggrmann Comfort Scale ( BCS ) , and Ramsay Sedation Scale were used to evaluate the sedative effect or analgesic effect , and their scores were recorded at administration hour ( AH ) 2 , 6 , 12 , 24 , and 48 .
-METHODS	The times of efficient injection and incidence of adverse effect within the 48 AH were recorded .
-METHODS	Data were processed with analysis of variance for repeated measurement , t test , chi-square test , and Fisher 's exact test .
-RESULTS	There were no obvious differences in the scores of VAS and BCS between two groups at each time point ( with t values from -0.426 to 0.864 , P values above 0.05 ) .
-RESULTS	The scores of Ramsay Sedation Scale in group S at AH 2 , 6 , 12 , 24 , and 48 were respectively ( 3.2 0.6 ) , ( 3.2 0.5 ) , ( 3.3 0.7 ) , ( 3.2 0.4 ) , and ( 3.3 0.4 ) points , which were higher than those in group DS [ ( 2.4 0.6 ) , ( 2.5 0.5 ) , ( 2.4 0.6 ) , ( 2.4 0.4 ) , and ( 2.4 0.5 ) points , with t values from 5.302 to 8.391 , P values below 0.001 ] .
-RESULTS	The times of efficient injection within the 48 AH was 6.8 0.7 in group S and 6.5 0.9 in group DS , showing no significantly statistical difference ( t = 1.260 , P > 0.05 ) .
-RESULTS	Respiratory depression was not observed in both groups ; the incidence of pruritus was the same , and that of urine retention was similar between the 2 groups within the 48 AH ( with P values above 0.05 ) .
-RESULTS	Within the 48 AH , the incidence of nausea and vomiting in group S was 26.7 % ( 8/30 ) , which was obviously higher than that in group DS ( 6.7 % , 2/30 , P < 0.05 ) ; the incidence of drowsiness in group S was 20.0 % ( 6/30 ) , which was significantly higher than that in group DS ( no patient , P < 0.05 ) .
-CONCLUSIONS	Dezocine combined with sufentanil can provide effective postoperative analgesia with little adverse effect for PCIA in burn patients after escharectomy or tangential excision followed by autologous skin grafting , therefore it can be widely used .
-
-###24818590
-OBJECTIVE	To evaluate the efficacy of the use of oral Prednisolone and heparin versus the use of heparin alone in treatment of patients with unexplained recurrent miscarriage .
-METHODS	The study was a double-blind placebo randomized control trial conducted on 160 patients with unexplained recurrent miscarriage .
-METHODS	Patients recruited were randomized into two groups .
-METHODS	The first group received oral Prednisolone in addition to low dose aspirin and heparin , while the other group received a placebo in addition to low dose aspirin and heparin .
-METHODS	A peripheral venous blood sample was taken from all included patients before starting treatment and collected in heparinized tubes .
-METHODS	Natural Killer ( NK ) cells were checked in each sample and then re-checked in another sample at 20weeks of gestation .
-RESULTS	We found that in the prednisolone group , 70.3 % of women had successful outcome ( defined as an ongoing pregnancy beyond 20weeks gestation ) , while 29.7 % miscarried before this gestation .
-RESULTS	On the contrary , among women in the placebo group , 9.2 % had successful outcome while 90.8 % miscarried before 20weeks , which was statistically significant .
-RESULTS	On the other hand , we found that there were no significant paired differences between initial serum levels of the NK cells markers CD16 and CD56 and their levels at 20weeks gestation in both groups .
-CONCLUSIONS	The addition of prednisolone to heparin and low dose aspirin might be beneficial in patients with unexplained recurrent miscarriage , and this effect might be due to a suppressive effect of steroids on the peripheral CD16 NK cells concentration .
-
-###25020155
-OBJECTIVE	The purpose of the current study was to test theory-based predictions of mediators and moderators of treatment effects of a pilot randomized controlled trial , which aimed to increase adherence to preventive medication in stroke survivors via addressing both automatic ( i.e. , habitual responses ) and reflective ( i.e. , beliefs and value systems ) aspects of medication-taking behavior .
-METHODS	Sixty-two stroke survivors were randomly allocated to either an intervention or control group .
-METHODS	Intervention participants received a brief 2-session intervention aimed at increasing adherence via ( a ) helping patients establish better medication-taking routines using implementation intentions plans ( automatic ) , and ( b ) eliciting and modifying any mistaken patient beliefs regarding medication and/or stroke ( reflective ) .
-METHODS	The control group received similar levels of non-medication-related contact .
-METHODS	Primary outcome was adherence to antihypertensive medicine measured objectively over 3 months using an electronic pill bottle .
-METHODS	Secondary outcome measures included self-reported adherence ( including forgetting ) and beliefs about medication .
-RESULTS	Intervention participants had 10 % greater adherence on doses taken on schedule ( intervention , 97 % ; control , 87 % ; 95 % CI [ 0.2 , 16.2 ] , p = .048 ) , as well as significantly greater increases in self-reported adherence and reductions in concerns about medication .
-RESULTS	Treatment effects were mediated by reductions in both forgetting and concerns about medication , and moderated by the presence of preexisting medication-taking routines .
-CONCLUSIONS	Addressing both automatic and reflective aspects of behavior via helping stroke survivors develop planned regular routines for medication-taking , and addressing any concerns or misconceptions about their medication , can improve adherence and thus potentially patient outcomes .
-
-###25352870
-BACKGROUND	Drug related problem ( DRPs ) is a key factor which will affect the outcome of therapy and safety .
-OBJECTIVE	To assess the DRPs in type 2 diabetes mellitus ( T2DM ) patients and psychological aspects of patients by community pharmacists to observe the rate of DRP .
-METHODS	Prospective randomized controlled intervention study involved T2DM patients and conducted in two community pharmacies at Kanpur from January 2012 to December 2012 .
-METHODS	The assessment of DRPs was based on the PCNE .
-METHODS	Changes in glycosylated hemoglobin ( HBA1c ) , low density lipoproteins ( LDL ) , blood pressure ( BP ) , foot examinations , changes medical and medication utilization were studied .
-METHODS	Using as control group , received usual care , and interventional group provided , intervened with use of the standard treatment guidelines ( STG ) .
-METHODS	Researcher provided the knowledge to community pharmacists and patients .
-METHODS	Baseline and interventional data were collected at 0,3,6,9 and 12 months .
-RESULTS	Over the 12 month study , participants ' average HBA1C reduced from 8.9 % at initial visit to 7.5 % .
-RESULTS	During this time , the eye examination rate was raised from 31 % to 48 % , and the foot examination rate was raised from 35 % to 50 % .
-CONCLUSIONS	The intervention of pharmacists showed little influence on any of the intermediate health outcomes in T2DM .
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-###25343191
-BACKGROUND	Abdominal adiposity may be an important risk factor for uncontrolled asthma in adults , controlling for general obesity .
-BACKGROUND	Whether the relationship , if present , is explained by other factors ( e.g. , asthma onset age , sex , and/or coexisting conditions ) is unclear .
-OBJECTIVE	To examine whether clinically applicable anthropometric measures of abdominal adiposity -- waist circumference and waist-to-height ratio ( WHtR ) -- are related to poorer asthma control in adults with uncontrolled asthma controlling for body mass index ( BMI ) , and whether the relationship ( if present ) is explained by gastroesophageal reflux disorder ( GERD ) , sleep quality , or obstructive sleep apnea ( OSA ) or differs by age of asthma onset or sex .
-METHODS	Patients aged 18 to 70 years with uncontrolled asthma ( n = 90 ) participated in a 6-month randomized clinical trial .
-RESULTS	Baseline measures included sociodemographics , standardized anthropometrics , Asthma Control Test ( ACT ) , GERD Symptom Assessment Scale , Pittsburgh Sleep Quality Index , and Berlin Questionnaire for Sleep Apnea .
-RESULTS	Participants ( mean [ SD ] age , 52 [ 12 ] yr ) were racially and ethnically diverse , 67 % women , and 69 % overweight or obese , and 71 % reported their age of asthma onset was 12 years or older .
-RESULTS	Participants had uncontrolled asthma ( mean [ SD ] ACT score , 14.9 [ 3.7 ] ) and low GERD symptoms score ( 0.6 [ 0.4 ] ) ; 67 % reported poor sleep quality , and 42 % had a high OSA risk .
-RESULTS	General linear regression results showed that worse ACT scores were significantly associated with every SD increase in waist circumference ( = -1.03 ; 95 % confidence interval [ CI ] , -1.96 to -0.16 ; P = 0.02 ) and waist-to-height ratio ( = -1.16 ; 95 % CI , -2.00 to -0.33 ; P = 0.008 ) , controlling for sociodemographics .
-RESULTS	Waist-to-height ratio remained correlated with ACT ( = -2.30 ; 95 % CI , -4.16 to -0.45 ; P = 0.02 ) after further adjusting for BMI .
-RESULTS	The BMI-controlled relationship between WHtR and ACT did not differ by age of asthma onset or sex ( P > 0.05 for interactions ) and persisted after additional adjustment for GERD , sleep quality , or OSA scores .
-RESULTS	Poor sleep quality was associated with worse ACT scores ( = -0.87 ; 95 % CI , -1.71 to -0.03 ; P = 0.045 ) controlling for waist-to-height ratio , BMI , and sociodemographics .
-CONCLUSIONS	Abdominal adiposity by waist-to-height ratio and poor sleep quality correlated with poorer asthma control in adults with uncontrolled asthma , after controlling for BMI and sociodemographics .
-CONCLUSIONS	These results warrant replication in larger studies of diverse populations .
-CONCLUSIONS	Clinical trial registered with www.clinicaltrials.gov ( NCT 01725945 ) .
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-###25465416
-BACKGROUND	Vorapaxar , a novel thrombin receptor antagonist , reduces cardiovascular death and recurrent thrombotic events when added to standard antiplatelet therapy in patients with stable atherosclerotic vascular disease .
-OBJECTIVE	The goal of this study was to test the hypothesis that treatment with vorapaxar reduces the rate of coronary stent thrombosis ( ST ) in stable patients with a history of coronary stenting .
-METHODS	TRA 2 P-TIMI 50 ( Trial to Assess the Effects of Vorapaxar in Preventing Heart Attack and Stroke in Patients With Atherosclerosis-Thrombolysis In Myocardial Infarction 50 ) was a multinational , randomized , double-blind , placebo-controlled trial of vorapaxar in stable patients with prior myocardial infarction , peripheral arterial disease , or stroke .
-METHODS	We evaluated the rates of definite ST as adjudicated by a central events committee using Academic Research Consortium ( ARC ) criteria .
-RESULTS	A total of 26,449 patients were randomized , with 14,042 ( 53 % ) having a history of a coronary stent implantation before randomization , and an additional 449 patients receiving a coronary stent during the trial ( total 14,491 ) .
-RESULTS	During follow-up ( median 2.5 years ) , there were 152 definite ST events , with the majority ( 92 % ) occurring late or very late .
-RESULTS	Vorapaxar reduced ARC definite ST ( 1.1 % vs. 1.4 % , hazard ratio [ HR ] : 0.71 , 95 % confidence interval [ CI ] : 0.51 to 0.98 ; p = 0.037 ) .
-RESULTS	The reduction was consistent , regardless of time from percutaneous coronary intervention , history of diabetes , use of drug-eluting stents , and use of dual antiplatelet therapy ( DAPT ) at randomization .
-RESULTS	Vorapaxar increased GUSTO moderate/severe bleeding ( HR : 1.57 , 95 % CI : 1.26 to 1.94 ; p < 0.001 ) .
-CONCLUSIONS	The rate of ARC definite ST in stable patients , the majority of whom were receiving DAPT , was approximately 1.4 % at 3 years .
-CONCLUSIONS	In stable patients with coronary stenting receiving standard antiplatelet therapy , vorapaxar administered for long-term secondary prevention significantly reduced ARC definite ST , including very late ST. ( Trial to Assess the Effects of Vorapaxar [ SCH 530348 ; MK-5348 ] in Preventing Heart Attack and Stroke in Patients With Atherosclerosis [ TRA 2 P-TIMI 50 ] [ P04737 ] ; NCT00526474 ) .
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-###25265887
-OBJECTIVE	To compare parenterally administered moderate sedation and paracervical block versus general anesthesia during day-case operative hysteroscopy for polypectomy in terms of patients ' postoperative pain perception , operating time , and postoperative drug administration .
-METHODS	A pilot study ( Canadian Task Force classification I ) .
-METHODS	A university hospital .
-METHODS	Women undergoing hysteroscopic polypectomy procedures ( N = 56 ) .
-METHODS	Hysteroscopic polypectomy with general anesthesia or moderate parenteral sedation and paracervical block .
-RESULTS	The patients were divided into 2 groups : 26 underwent general anesthesia ( group 1 ) , and 30 were submitted to moderate parenteral sedation and a paracervical block ( group 2 ) .
-RESULTS	General anesthesia was induced with the laryngeal mask airway with propofol ( 1 % 1-2 .5 mg/kg ) and fentanyl ( 1-2g / kg ) and maintained with an infusion of propofol ( 2 % 3-5mg / kg/h ) .
-RESULTS	After the procedure , patients in the general anesthesia group received postoperative analgesic medication with paracetamol ( 20mg/kg ) and ketorolac ( 0.6 mg/kg ) or tramadol ( 2-3mg / kg ) .
-RESULTS	The group receiving moderate parenterally sedation and a paracervical block received a paracervical block with mepivacaine ( 1 % 10mL ) and lidocaine ( 2 % 10mL ) and received fentanyl ( 1g/kg ) and propofol ( 1 % 1-3mg / kg/h ) maintaining spontaneous breathing .
-RESULTS	A blind observer recorded the operative time and the discomfort of patients using a 4-step scale ( 0-3 ) .
-RESULTS	The postoperative pain assessment was performed 3hours after the procedure with a self-administered validated tool , the Brief Pain Inventory .
-RESULTS	We found that women receiving moderate parenteral sedation and a paracervical block perceived significantly less pain in daily activity ( p < .001 ) , walking ( p < .001 ) , daily work ( p < .001 ) , relations with others ( p = .007 ) , sleep ( p < .001 ) , and pain contrasting enjoyment of life ( p < .001 ) .
-RESULTS	The total amount of time spent in the operating room in group 2 was significantly lower than in group 1 ( p < .014 ) .
-CONCLUSIONS	Moderate sedation plus a paracervical block for operative hysteroscopy is associated with reduced pain perception and a shorter operative time .
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-###24438128
-OBJECTIVE	To evaluate the long-term efficacy of the Epley manoeuvre as a therapeutic procedure for posterior canal benign paroxysmal positional vertigo .
-METHODS	Randomised , double-blind , sham-controlled trial .
-METHODS	A multidisciplinary dizziness unit in a non-academic Hospital .
-METHODS	Forty-four patients with posterior canal benign paroxysmal positional vertigo ( BPPV ) with a duration of at least 1 month .
-METHODS	Participants were randomised in two groups of 22 and treated with either the Epley manoeuvre or a sham manoeuvre and followed up for 1 year after treatment .
-METHODS	Conversion of a ` positive ' Dix-Hallpike test to a ` negative ' Dix-Hallpike test , impairments perceived by the dizziness assessed by the Dizziness Handicap Inventory ( DHI ) .
-METHODS	Absolute and relative risks were computed , and Fisher 's exact test was used to compare the treatments .
-RESULTS	Six patients were lost to follow up ( five in the sham group , one in the Epley group ) .
-RESULTS	The Epley procedure resulted in a treatment success in 20/22 patients ( 91 % ) after 12 months of follow-up , whereas the sham procedure had a positive effect in 10/22 patients ( 46 % ; P = 0.001 ) .
-RESULTS	The DHI was significantly lower in the Epley group at all follow-up assessments ( median scores 12 months 0 ( 0-51 ) versus 20 ( 0-76 ) , P = 0.003 ) .
-CONCLUSIONS	The Epley manoeuvre provides long-term resolution of symptoms in patients with posterior canal BPPV .
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-###24555620
-OBJECTIVE	The primary purpose of this study was to evaluate the detection rate of local radiorecurrent prostate cancer by using diffusion-weighted MR imaging ( DWI ) and targeted biopsies .
-OBJECTIVE	The secondary purpose was to assess the value of performing random biopsies .
-METHODS	This study included 42 consecutive patients with biochemical recurrence after external beam radiation therapy ( EBRT ) .
-METHODS	At the time of biopsy , the mean ageSD was 676 years , median serum prostate-specific antigen level was 4.03.0 ng/mL , and mean elapsed time between EBRT and biopsy was 5.62.8 years .
-METHODS	MRI examination included high-resolution axial T2-weighted and DWI sequences and was classified as either negative or positive .
-METHODS	Transrectal ultrasound-guided targeted biopsies were obtained from all patients with positive findings on MRI using a soft image fusion system .
-METHODS	Random sextant biopsies were obtained from both lobes in patients with negative findings on MRI and from the lobe contralateral to the MRI target in patients with positive findings on MRI .
-METHODS	The biopsy results were classified as negative or positive and defined as the criterion standard .
-RESULTS	MRI findings were positive in 40 of 42 ( 95 % ) patients , and the overall positive biopsy rate was 79 % ( 33 of 42 patients ) .
-RESULTS	Targeted biopsies were positive in 33 of 40 ( 83 % ) patients .
-RESULTS	Random biopsies were positive in 6 of 30 ( 20 % ) patients , all of whom had positive targeted biopsies .
-CONCLUSIONS	DWI is highly sensitive for detecting radiorecurrent prostate cancer , and a few targeted biopsies may confirm a positive diagnosis .
-CONCLUSIONS	However , random biopsies may assess the tumor burden more exactly .
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-###24275482
-OBJECTIVE	In this study we compared silver nitrate cautery with placebo to assess the effect of silver nitrate cautery in aphthous stomatitis for pain relief and healing time .
-METHODS	In this study , sixty-five patients with aphthous stomatitis were assessed .
-METHODS	Silver nitrate sticks were used in group A ( treatment group ) and placebo sticks were used for group B ( control group ) .
-METHODS	Change in the severity of pain , change in the size of the ulcers , healing time , side effects of the procedure were assessed .
-RESULTS	Although the mean value of pain scores before the procedure was similar in both of the groups , there were statistically significant differences between two groups after the procedure on the first to the seventh day .
-RESULTS	On the seventh day after the procedure , the ulcers were completely reepithelialized in 21 patients ( 60 % ) in the treatment group and in 10 patients ( 32 % ) in the placebo group .
-RESULTS	The difference was statistically significant ( p < 0.01 ) .
-RESULTS	In the treatment group , the mean healing time of ulcers , reported by these 21 patients , was 2.7 days ( range 2-4 ) after the procedure .
-RESULTS	In the placebo group , the mean healing time of ulcers , reported by 10 patients with healed ulcers , was 5.5 days ( range 4-7 ) after the procedure .
-RESULTS	The difference was statistically significant ( p < 0.01 ) .
-RESULTS	No side effects were recorded in either of the groups .
-CONCLUSIONS	In conclusion , silver nitrate cautery appears to be an effective and rapid treatment option for pain relief in aphthous stomatitis .
-CONCLUSIONS	Also this treatment shortens the healing time of ulcers .
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-###24414439
-OBJECTIVE	The optimal fixation of the Rotaglide total knee arthroplasty 's ( TKA ) components is controversial .
-OBJECTIVE	It is hypothesized that the hybrid fixation ( cementless femoral component ) in a mobile-bearing TKA system might cause increased rate of loosening -- especially in the femoral part -- and finally failure of the arthroplasty .
-OBJECTIVE	Consequently , the aim of this study was to compare the survival and revision rates and also the clinical and radiological outcomes of the cemented and hybrid fixation of the Rotaglide TKA .
-METHODS	One hundred patients , who underwent TKA with the Rotaglide prosthesis , were randomly placed in two groups .
-METHODS	In the first group , the prosthesis was cemented , and in the second group , the hybrid technique was used .
-METHODS	Revision and mortality rates were compared after 8-12 years of follow-up .
-METHODS	Knee and Osteoarthritis Outcome Score ( KOOS ) questionnaire and the Knee Society Roentgenographic Evaluation and Scoring System were used to demonstrate clinical and radiographic differences .
-RESULTS	There were no statistically significant differences in revision ( n.s. ) or mortality ( n.s. ) rates between the two treatment arms .
-RESULTS	The clinical outcome at the time of last follow-up ( mean 9.5 years , SD 1.4 ) ranged from very good to excellent ( 77.8 17.5 for the cemented group and 77.2 20.4 for the hybrid group ) .
-RESULTS	No statistically significant differences in all KOOS subscales .
-RESULTS	Radiographs showed no significant difference in prosthesis alignment and no evidence of loosening between groups .
-CONCLUSIONS	The hypothesis that the hybrid fixation in a mobile-bearing TKA system might cause increased rate of loosening and finally failure of the arthroplasty was not confirmed .
-CONCLUSIONS	The fixation technique ( cemented or hybrid ) had no influence on the prosthesis 's survivorship , and also on mortality rates , clinical and radiographic outcomes in a mean follow-up time of 9.5 1.4 years .
-CONCLUSIONS	The Rotaglide TKA is a safe and reliable prosthesis regardless the fixation technique .
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-###24988105
-OBJECTIVE	To explore the relationship between worksite physical environment and employee dietary intake , physical activity behavior , and weight status .
-METHODS	Two trained research assistants completed audits ( Checklist of Health Promotion Environments at Worksites ) at each worksite ( n = 28 ) .
-METHODS	Employees ( n = 6261 ) completed a brief health survey before participation in a weight loss program .
-RESULTS	Employees ' access to outdoor areas was directly associated with lower body mass index ( BMI ) , whereas access to workout facilities within a worksite was associated with higher BMI .
-RESULTS	The presence of a cafeteria and fewer vending machines was directly associated with better eating habits .
-RESULTS	Better eating habits and meeting physical activity recommendations were both related to lower BMI .
-CONCLUSIONS	Selected environmental factors in worksites were significantly associated with employee behaviors and weight status , providing additional intervention targets to change the worksite environment and promote employee weight loss .
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-###26014298
-OBJECTIVE	As glioblastoma progresses , patients experience a decline in health-related quality of life ( HRQoL ) .
-OBJECTIVE	Delaying this decline is an important treatment goal .
-OBJECTIVE	In newly diagnosed glioblastoma , progression-free survival was prolonged when bevacizumab was added to radiotherapy plus temozolomide ( RT/TMZ ) versus placebo plus RT/TMZ ( phase III AVAglio study ; hazard ratio , 0.64 ; 95 % CI , 0.55 to 0.74 ; P < .001 ) .
-OBJECTIVE	To ensure that addition of bevacizumab to standard-of-care therapy was not associated with HRQoL detriment , HRQoL assessment was a secondary objective .
-METHODS	Patients completed European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires C30 and BN20 at each tumor assessment ( Appendix Table A1 , online only ) .
-METHODS	Raw scores were converted to a 100-point scale and mean changes from baseline scores were evaluated ( stable : < 10-point change ; clinically relevant deterioration/improvement : 10-point change ) .
-METHODS	Deterioration-free survival was the time to deterioration/progression/death ; time to deterioration was the time to deterioration/death .
-RESULTS	Most evaluable patients who had not progressed ( > 74 % ) completed all HRQoL assessments for at least 1 year of treatment , and almost all completed at least one HRQoL assessment at baseline ( 98.3 % and 97.6 % , bevacizumab and placebo arms , respectively ) .
-RESULTS	Mean changes from baseline did not reach a clinically relevant difference between arms for most items .
-RESULTS	HRQoL declined at progression in both arms .
-RESULTS	The addition of bevacizumab to RT/TMZ resulted in statistically longer ( P < .001 ) deterioration-free survival across all items .
-RESULTS	Time to deterioration was not statistically longer in the placebo plus RT/TMZ arm ( v bevacizumab ) for any HRQoL item .
-CONCLUSIONS	The addition of bevacizumab to standard-of-care treatment for newly diagnosed glioblastoma had no impact on HRQoL during the progression-free period .
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-###26005977
-OBJECTIVE	To examine the usefulness of an absorbable hemostatic gelatin sponge for hemostasis after transrectal prostate needle biopsy .
-METHODS	The subjects comprised 278 participants who underwent transrectal prostate needle biopsy .
-METHODS	They were randomly allocated to the gelatin sponge insertion group ( group A : 148 participants ) and to the non-insertion group ( group B : 130 participants ) .
-METHODS	In group A , the gelatin sponge was inserted into the rectum immediately after biopsy .
-METHODS	A biopsy-induced hemorrhage was defined as a case in which a subject complained of bleeding from the rectum , and excretion of blood clots was confirmed .
-METHODS	A blood test was performed before and after biopsy , and a questionnaire survey was given after the biopsy .
-RESULTS	Significantly fewer participants in group A required hemostasis after biopsy compared to group B ( 3 ( 2.0 % ) vs. 11 ( 8.5 % ) , P = 0.029 ) .
-RESULTS	The results of the blood tests and the responses from the questionnaire did not differ significantly between the two groups .
-RESULTS	In multivariate analysis , only `` insertion of a gelatin sponge into the rectum '' emerged as a significant predictor of hemostasis .
-CONCLUSIONS	Insertion of a gelatin sponge into the rectum after transrectal prostate needle biopsy significantly increases hemostasis without increasing patient symptoms , such as pain and a sense of discomfort .
-
-###24809482
-BACKGROUND	The benefit of inducing deep neuromuscular block to improve laparoscopic surgical conditions is controversial .
-OBJECTIVE	The goal of this study was to determine the depth of neuromuscular block needed to guarantee excellent operating conditions during laparoscopic hysterectomy .
-METHODS	A randomised controlled trial .
-METHODS	A single-centre study performed between February 2011 and May 2012 .
-METHODS	One hundred and two women of ASA physical status 1 or 2 gave consent to participate and were allocated randomly to one of two groups .
-METHODS	Under desflurane general anaesthesia , patients in Group S ( shallow block ) , neuromuscular blockade was induced by administration of rocuronium 0.45 mg kg-1 followed by spontaneous recovery or a rescue bolus dose of 5 mg if surgical conditions were unacceptable .
-METHODS	In Group D ( deep block ) , neuromuscular block was induced by administration of rocuronium 0.6 mg kg-1 and maintained by bolus doses of 5 mg if the train-of-four count exceeded two , using adductor pollicis electromyography .
-METHODS	With a stable pneumoperitoneum ( 13mmHg ) , the surgeon scored the quality of the surgical field every 10 min as excellent ( 1 ) , good but not optimal ( 2 ) , poor but acceptable ( 3 ) or unacceptable ( 4 ) .
-METHODS	The groups were compared using the Cochran-Armitage trend test .
-METHODS	The level of neuromuscular blockade was recorded each time the surgical field score exceeded 1 .
-RESULTS	For groups S and D , respectively , the maximum surgical field scores were 1 in 21 and 34 patients , 2 in 11 and 11 patients , 3 in 4 and 5 patients and 4 in 14 and 0 patients .
-RESULTS	A trend towards higher scores was demonstrated in group S ( P < 0.001 ) .
-RESULTS	Surgical field scores of 2 , 3 and 4 occurred only when the train-of-four count was at least 1 , 2 and 3 , respectively .
-CONCLUSIONS	Inducing deep neuromuscular block ( train-of-four count < 1 ) significantly improved surgical field scores and made it possible to completely prevent unacceptable surgical conditions .
-
-###25566703
-BACKGROUND	Numerous studies have reported predictors of new-onset postoperative atrial fibrillation ( POAF ) following cardiac surgery , which is associated with increased length of stay , cost of care , morbidity , and mortality .
-BACKGROUND	The purpose of this study was to examine the association between preoperative diastolic function and occurrence of new-onset POAF in patients undergoing a variety of cardiac surgeries at a single institution .
-METHODS	Using data from a prospective study from November 2007 to January 2010 , a retrospective review was conducted .
-METHODS	The diastolic function of each patient was determined from preoperative transthoracic echocardiograms .
-METHODS	Occurrence of new-onset POAF was prospectively noted for each patient in the original study .
-METHODS	Demographic and operative characteristics of the study population were analyzed to determine predictors of POAF .
-RESULTS	Of 223 patients , 91 ( 40.8 % ) experienced new-onset POAF .
-RESULTS	Univariate predictors of POAF included increasing age , male gender , operations involving mitral valve repair/replacement , nonsmoking , hypertension , increased intraoperative pulmonary artery pressure , grade I diastolic dysfunction , abnormal diastolic function of any grade , decreased medial e ' , elevated medial E/e ' , and increased left atrial volume .
-RESULTS	Multivariate predictors of POAF included increasing age , increased left atrial volume , and elevated initial intraoperative pulmonary artery pressure .
-RESULTS	Even after exclusion of patients with hypertrophic obstructive cardiomyopathy or those undergoing mitral valve operations , diastolic dysfunction was not a multivariate predictor of POAF .
-CONCLUSIONS	In the patient population studied here , preoperative diastolic dysfunction was not predictive of POAF .
-CONCLUSIONS	In addition to increasing age , initial intraoperative pulmonary artery systolic pressure and left atrial volume were both significant multivariate predictors of POAF .
-
-###24834811
-BACKGROUND	Nintedanib is in clinical development as a treatment for idiopathic pulmonary fibrosis ( IPF ) .
-BACKGROUND	Data from the Phase II TOMORROW study suggested that nintedanib 150mg twice daily had clinical benefits with an acceptable safety profile .
-METHODS	The INPULSIS trials are replicate Phase III , randomized , double-blind , studies comparing the efficacy and safety of nintedanib 150mg twice daily with placebo in patients with IPF .
-METHODS	Eligible patients were aged 40 years with a diagnosis of IPF within 5 years before randomization who had undergone a chest high-resolution computed tomography ( HRCT ) scan within 1-year before screening , and who had a forced vital capacity ( FVC ) of 50 % predicted and a diffusing capacity for carbon monoxide of 30-79 % predicted .
-METHODS	Participants were randomized 3:2 to receive nintedanib or placebo for 52 weeks .
-METHODS	The primary endpoint is the annual rate of decline in FVC .
-METHODS	The key secondary endpoints are change from baseline in the total score on the St. George 's Respiratory Questionnaire ( a measure of health-related quality of life ) over 52 weeks and time to first acute exacerbation .
-RESULTS	Enrolment of 1066 patients in 24 countries was completed in September 2012 .
-RESULTS	Results will be reported in the first half of 2014 .
-CONCLUSIONS	The INPULSIS trials will determine the efficacy of nintedanib in patients with IPF , including its impact on disease progression as defined by decline in FVC , acute exacerbations and health-related quality of life .
-CONCLUSIONS	In addition , they will characterise the adverse event profile of nintedanib in this patient population .
-BACKGROUND	Registered at ClinicalTrials.gov ( identifiers : NCT01335464 and NCT01335477 ) .
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-###25624076
-OBJECTIVE	To compare the maximum change in numeric rating scale ( NRS ) pain scores , in patients receiving low-dose ketamine ( LDK ) or morphine ( MOR ) for acute pain in the emergency department .
-METHODS	We performed an institutional review board-approved , randomized , prospective , double-blinded trial at a tertiary , level 1 trauma center .
-METHODS	A convenience sample of patients aged 18 to 59 years with acute abdominal , flank , low back , or extremity pain were enrolled .
-METHODS	Subjects were consented and randomized to intravenous LDK ( 0.3 mg/kg ) or intravenous MOR ( 0.1 mg/kg ) .
-METHODS	Our primary outcome was the maximum change in NRS scores .
-METHODS	A sample size of 20 subjects per group was calculated based on an 80 % power to detect a 2-point change in NRS scores between treatment groups with estimated SDs of 2 and an of .05 , using a repeated-measures linear model .
-RESULTS	Forty-five subjects were enrolled ( MOR 21 , LDK 24 ) .
-RESULTS	Demographic variables and baseline NRS scores ( 7.1 vs 7.1 ) were similar .
-RESULTS	Ketamine was not superior to MOR in the maximum change of NRS pain scores , MOR = 5 ( confidence interval , 6.6-3 .5 ) and LDK = 4.9 ( confidence interval , 5.8-4 ) .
-RESULTS	The time to achieve maximum reduction in NRS pain scores was at 5 minutes for LDK and 100 minutes for MOR .
-RESULTS	Vital signs , adverse events , provider , and nurse satisfaction scores were similar between groups .
-CONCLUSIONS	Low-dose ketamine did not produce a greater reduction in NRS pain scores compared with MOR for acute pain in the emergency department .
-CONCLUSIONS	However , LDK induced a significant analgesic effect within 5 minutes and provided a moderate reduction in pain for 2 hours .
-
-###24819506
-OBJECTIVE	To assess the effects of sodium pentosan polysulfate ( PPS ) , N-acetyl glucosamine ( NAG ) , and sodium hyaluronan ( HA ) in horses with induced osteoarthritis ( OA ) .
-METHODS	Experimental .
-METHODS	Adult Standard bred horses ( n = 16 ) .
-METHODS	OA was induced arthroscopically in 1 intercarpal joint ; 8 horses were administered 3mg/kg PPS , 4.8 mg/kg NAG , and 0.12 mg/kg HA ( PGH ) , intravenously ( IV ) , weekly and 8 horses were administered an equivalent volume of saline IV until study completion ( day 70 ) .
-METHODS	Horses underwent a standardized treadmill exercise program .
-METHODS	Clinical and radiographic findings and synovial fluid analysis were evaluated throughout the study .
-METHODS	Macroscopic , histologic , histochemical , and biochemical findings were evaluated after necropsy .
-METHODS	Comparisons of interest included OA and non-OA joints of saline treated horses and OA joints of PGH treated horses and OA joints of saline treated horses .
-METHODS	Results were statistically analyzed with significance set at P < .05 .
-RESULTS	OA caused increases in clinical assessment scores , synovial fluid variables , radiographic , macroscopic , and histologic cartilage scores , synovial fluid and cartilage chondroitin sulfate 846-epitope and glycosaminoglycan concentration .
-RESULTS	Total radiographic scores , total macroscopic joint pathology and macroscopic cartilage pathology scores were significantly reduced in horses treated with PGH compared with saline treated horses .
-RESULTS	Synovial fluid total protein concentration and white blood cell count were higher in OA joints of PGH treated horses compared with saline treated horses .
-RESULTS	There were no other significant differences between treatment groups .
-CONCLUSIONS	Improvements in macroscopic variables were not supported by other outcomes .
-CONCLUSIONS	Further evidence is needed before PGH can be recommended as a therapeutic option for osteoarthritis in horses .
-
-###25079090
-BACKGROUND	The prevention of mother-to-child transmission of human immunodeficiency virus ( HIV ) is lauded as one of the more successful HIV prevention measures .
-BACKGROUND	However , despite some gains in the prevention of mother-to-child transmission of HIV ( PMTCT ) in sub-Saharan Africa , mother-to-child transmission rates are still high .
-BACKGROUND	In Kenya , mother-to-child transmission is considered one of the greatest health challenges and scaling up PMTCT services is crucial to its elimination by 2015 .
-BACKGROUND	However , guideline implementation faces barriers that challenge scale-up of services .
-BACKGROUND	The objective of this paper is to identify barriers to PMTCT implementation in the context of a randomized control trial on the use of structured mobile phone messages in PMTCT .
-METHODS	The preliminary analysis presented here is based on survey data collected during enrolment in PMTCT services at one of two health facilities in Nairobi , Kenya , with overall number of antenatal care ( ANC ) visits determined from 48 hour follow up data .
-RESULTS	Data was collected for 503 women .
-RESULTS	Despite significant differences in the type of facility and sample characteristics between sites , all women presented to care at 20 weeks gestation or later and 88.8 % attended less than four ANC visits .
-RESULTS	PMTCT counselling at first visit had high coverage ( 86 % ) , however less than a third of women ( 31.34 % ) reported receiving contraception counselling .
-RESULTS	Although 60.8 % of women had reportedly disclosed their status to their partners , only 40 % were aware of their partner 's status .
-RESULTS	Very few women had been tested for TB ( 10 % ) or received single dose nevirapine during their first antenatal care appointment ( 20 % ) .
-CONCLUSIONS	Revised PMTCT guidelines aim to reduce the inequity between PMTCT services in high and low resource settings in efforts to eliminate mother-to-child transmission .
-CONCLUSIONS	However , guideline implementation in low resource settings continues to be confronted with challenges related to late presentation , less than four ANC visits , low screening rates for opportunistic infections , and limited contraception counselling .
-CONCLUSIONS	These challenges are further complicated by lack of disclosure to partners .
-CONCLUSIONS	Effective scale up and implementation of PMTCT services requires that such ongoing program challenges be identified and appropriately addressed within the local context .
-
-###24654220
-OBJECTIVE	This study examined whether the choice of pain-related outcome to represent opioid efficacy influenced findings in a genetic association study .
-OBJECTIVE	Data from the European Pharmacogenetic Opioid Study , which used opioid dose as the outcome , were analysed in respect of six alternative outcomes : average pain intensity , pain right now , worst pain intensity , pain at its least , pain relief and pain interference .
-METHODS	Cancer pain patients using an opioid for moderate or severe pain were included .
-METHODS	The pain outcomes were obtained using the Brief Pain Inventory .
-METHODS	Genetic variation was analysed for 112 single nucleotide polymorphisms ( SNPs ) in 25 candidate genes relevant for opioid efficacy .
-METHODS	The patients were randomly divided into a development and a validation sample and linear regression was used to compare the equality of means in the six outcomes .
-METHODS	The influence of non-genetic factors was controlled for , the regression analyses were stratified by country , and the results were corrected for multiple testing .
-RESULTS	2201 cancer pain patients were included .
-RESULTS	Their mean age was 62.4 years and mean average pain was 3.5 .
-RESULTS	None of the examined SNPs exceeded p values corrected for multiple testing for any of the outcomes .
-CONCLUSIONS	None of the outcomes were associated with variation in the selected SNPs , as previously shown for opioid dose .
-CONCLUSIONS	Thus , we observed that findings related to associations between genetic variability and opioid efficacy were consistent for several alternative outcomes .
-
-###25619692
-BACKGROUND	Surgical treatment with open reduction and internal fixation ( ORIF ) of displaced middle-third clavicular fractures resulted in shorter complete return to work periods with earlier consolidation documented on computed tomography ( CT ) scans in this prospective , randomized controlled trial .
-METHODS	The study randomized 76 consecutive patients with displaced fractures ( 2B1-2B2 according to Robinson ) to conservative ( C , n = 42 ) and surgical ( S , n = 34 ) treatment with plates and screws .
-METHODS	Bone union was documented with CT scans at 6 and 12 weeks .
-RESULTS	Risk factors known to increase the risk of nonunion were similar between groups .
-RESULTS	Time until discharge for complete return to work was 3.7 1.1 months for C and 2.9 0.8 months for S ( P = .003 ) .
-RESULTS	On the CT scan at 6 weeks , 24.1 % of the patients presented advanced bone union in S vs 5.3 % in C ( P = .05 ) .
-RESULTS	At 12 weeks , 81 % of the patients presented advanced bone union in S vs 16.7 % in C ( P = .005 ) .
-RESULTS	At final follow-up , 4 nonunions were present in the C group that required surgery ; in the S group , 4 patients underwent revision surgery for plate removal .
-RESULTS	At 6 and 12 months of follow-up , Constant scores were higher for the S group .
-CONCLUSIONS	Surgical treatment with ORIF of displaced middle-third clavicular fractures achieved good and excellent functional results , shorter time to complete return to work , earlier bone union , and fewer cases of nonunions in a working population under injury compensation .
-
-###25317794
-OBJECTIVE	The objective of this study is to evaluate the auditory functions in chronic asthma patients with the use of pure tone high frequency audiometry .
-METHODS	Twenty-two healthy controls and 42 adult patients were included as a prospective , randomized , and controlled study .
-METHODS	Pulmonary function tests and blood gas studies were completed on all subjects .
-METHODS	Asthma patients have divided into two groups [ Group A : Arterial oxygen tension ( PaO2 ) > 75 mmHg , Group B : PaO2 75 mmHg , Group C : Control group ) .
-METHODS	Acoustic assessments of patients were performed in 250-20 ,000 Hz by using pure-tone audiometry ( PTA ) and tympanometry .
-RESULTS	The mean value of air and bone conduction hearing threshold levels were in normal range for all groups .
-RESULTS	All patients had normal peripheral hearing all threshold levels across 250 Hz to 3000 Hz in the both ears .
-RESULTS	Significant differences were observed between the chronic asthma patients and control group for the extended high frequencies ( 10,000-20 ,000 Hz ) .
-RESULTS	Group B had statistically more significant increased hearing threshold levels than Group A in frequencies higher than 10,000 Hz .
-RESULTS	There were no statistical differences between the hearing threshold levels and FEV1 , FVC , FEV1/FVC and tympanogram results in the groups .
-CONCLUSIONS	This is the first study of evaluating the auditory functions in asthma patients .
-CONCLUSIONS	Sensorineural hearing loss in high frequencies ( 10,000 Hz-20 ,000 Hz ) is common in chronic asthma and is probably present more often than were formerly thought .
-
-###25057155
-BACKGROUND	After the oral administration of iron , the production of circulating non-transferrin-bound iron may contribute to an increased risk of illness in malaria-endemic areas that lack effective medical services .
-OBJECTIVE	In healthy women with a range of body iron stores , we aimed to determine effects on the production of circulating non-transferrin-bound iron resulting from the oral administration of 1 ) a supplemental dose of iron ( 60 mg ) with water , 2 ) a supplemental dose of iron ( 60 mg ) with a standard test meal , and 3 ) a fortification dose of iron ( 6 mg ) with a standard test meal .
-METHODS	With the use of serum ferritin as the indicator , healthy women with replete iron stores ( ferritin concentration > 25 g/L ; n = 16 ) and reduced iron stores ( ferritin concentration 25 g/L ; n = 16 ) were enrolled in a prospective , randomized , crossover study .
-METHODS	After the oral administration of aqueous solutions of ferrous sulfate isotopically labeled with Fe , Fe , or Fe , blood samples were collected for 8 h , and iron absorption was estimated by erythrocyte incorporation at 14 d.
-RESULTS	At 4 h , serum non-transferrin-bound iron reached peaks with geometric mean ( 95 % CI ) concentrations of 0.81 mol/L ( 0.56 , 1.1 mol/L ) for 60 mg Fe with water and 0.26 mol/L ( 0.15 , 0.38 mol/L ) for 60 mg Fe with food but was at assay limits of detection ( 0.1 mol Fe/L ) for 6 mg Fe with food .
-RESULTS	For the 60 mg Fe without food , the area under the curve over 8 h for serum non-transferrin-bound iron was positively correlated with the amount of iron absorbed ( R = 0.49 , P < 0.01 ) and negatively correlated with serum ferritin ( R = -0.39 , P < 0.05 ) .
-CONCLUSIONS	In healthy women , the production of circulating non-transferrin-bound iron is determined by the rate and amount of iron absorbed .
-CONCLUSIONS	The highest concentrations of non-transferrin-bound iron resulted from the administration of supplemental doses of iron without food .
-CONCLUSIONS	Little or no circulating non-transferrin-bound iron resulted from the consumption of a meal with a fortification dose of iron .
-
-###25400472
-OBJECTIVE	To investigate the effect of perioperative restricted fluid therapy on circulating CD4 ( + ) / CD8 ( + ) T lymphocyte ratio , percentage of regulatory T cells ( Treg ) and postoperative complications in patients with colorectal cancer .
-METHODS	A total of 185 patients met the inclusion criteria and were included in the randomized clinical trial .
-METHODS	These patients were divided into two groups according to receipt of either perioperative standard ( S , n = 89 ) or restricted ( R , n = 96 ) fluid therapy .
-METHODS	Clinical data of these patients were collected in this prospective study .
-METHODS	Perioperative complications and cellular immunity changes ( CD4 ( + ) / CD8 ( + ) and Treg ) were analyzed comparatively between the two groups .
-RESULTS	Both during surgery and on postoperative days , the total volumes of fluids administered in the R group were significantly lower than those in the S group ( 1620 430 mL vs 3110 840 mL ; 2090 360 mL vs 2750 570 mL ; 1750 260 mL vs 2740 490 mL ; 1620 310 mL vs 2520 300 mL ; P < 0.05 ) .
-RESULTS	Decreased ratios of circulating CD4 ( + ) / CD8 ( + ) T lymphocytes ( 1.47 0.28 vs 2.13 0.26 ; 1.39 0.32 vs 2.21 0.24 ; P < 0.05 ) and Treg percentage values ( 2.79 1.24 vs 4.26 1.04 ; 2.46 0.98 vs 4.30 1.12 ; P < 0.05 ) were observed after surgery in both groups .
-RESULTS	However , in the R group , these values restored more quickly starting from postoperative day 2 ( 1.44 0.24 vs 1.34 0.27 ; 2.93 1.08 vs 2.52 0.96 ; P < 0.05 ) .
-RESULTS	The proportion of patients with complications was significantly lower in the restricted group ( 36 of 89 vs 59 of 96 , P < 0.01 ) .
-CONCLUSIONS	Perioperative restricted intravenous fluid regimen leads to a low postoperative complication rate and better cellular immunity preservation in patients with colorectal cancer .
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-###25769076
-BACKGROUND	During times of organ scarcity and extended use of liver grafts , protective strategies in transplantation are gaining importance .
-BACKGROUND	We demonstrated in the past that volatile anesthetics such as sevoflurane attenuate ischemia-reperfusion injury during liver resection .
-BACKGROUND	In this randomized study , we examined if volatile anesthetics have an effect on acute graft injury and clinical outcomes after liver transplantation .
-METHODS	Cadaveric liver transplant recipients were enrolled from January 2009 to September 2012 at 3 University Centers ( Zurich/Sao Paulo/Ghent ) .
-METHODS	Recipients were randomly assigned to propofol ( control group ) or sevoflurane anesthesia .
-METHODS	Postoperative peak of aspartate transaminase was defined as primary endpoint , secondary endpoints were early allograft dysfunction , in-hospital complications , intensive care unit , and hospital stay .
-RESULTS	Ninety-eight recipients were randomized to propofol ( n = 48 ) or sevoflurane ( n = 50 ) .
-RESULTS	Median peak aspartate transaminase after transplantation was 925 ( interquartile range , 512-3274 ) in the propofol and 1097 ( interquartile range , 540-2633 ) in the sevoflurane group .
-RESULTS	In the propofol arm , 11 patients ( 23 % ) experienced early allograft dysfunction , 7 ( 14 % ) in the sevoflurane one ( odds ratio , 0.64 ( 0.20 to 2.02 , P = 0.45 ) .
-RESULTS	There were 4 mortalities ( 8.3 % ) in the propofol and 2 ( 4.0 % ) in the sevoflurane group .
-RESULTS	Overall and major complication rates were not different .
-RESULTS	An effect on clinical outcomes was observed favoring the sevoflurane group ( less severe complications ) , but without significance .
-CONCLUSIONS	This first multicenter trial comparing propofol with sevoflurane anesthesia in liver transplantation shows no difference in biochemical markers of acute organ injury and clinical outcomes between the 2 regimens .
-CONCLUSIONS	Sevoflurane has no significant added beneficial effect on ischemia-reperfusion injury compared to propofol .
-
-###24577643
-BACKGROUND	Cardiorespiratory fitness , assessed during cardiopulmonary exercise tests by peak oxygen uptake ( Vo2pk ) , is an independent predictor of mortality in obesity .
-BACKGROUND	We investigated whether Vo2pk and systemic responses measured during field walking tests were similar to those measured during an incremental treadmill test ( ITMT ) in obese individuals with treated OSA .
-METHODS	Individuals with treated OSA and a BMI > 30 kg/m2 were recruited .
-METHODS	Participants completed an ITMT , two 6-min walk tests ( 6MWTs ) , and two incremental shuttle walk tests ( ISWTs ) on three separate days in a randomized order .
-METHODS	Expired gas analysis was performed during all tests .
-RESULTS	The study was completed by 16 patients ( nine men ) ( mean [ SD ] age , 58 [ 12 ] y ; BMI , 36.1 [ 7.6 ] kg/m2 ) .
-RESULTS	There was no difference ( P = .27 ) in Vo2pk assessed by the ITMT and the ISWT ( 2,266 [ 478 ] and 2,017 [ 561 ] mL/min , respectively ) .
-RESULTS	The Vo2pk measured by the 6MWT ( 1,778 [ 360 ] mL/min ) was lower than that measured by the ITMT ( P < .01 ) .
-RESULTS	The limits of agreement for Vo2pk between the ISWT and the ITM were 730 mL/min .
-RESULTS	Cardiorespiratory responses during the ISWT and the ITMT reflected a graded response to a peak , whereas the 6MWT demonstrated a rapid rise to a plateau .
-CONCLUSIONS	The ISWT can be used instead of an ITMT and in preference to the 6MWT to assess cardiorespiratory fitness for a cohort of obese people with treated OSA .
-CONCLUSIONS	However , the imprecision of the agreement in Vo2pk between the ITMT and ISWT means they can not be used interchangeably in an individual .
-BACKGROUND	ClinicalTrials.gov ; No. : NCT01930513 ; www.clinicaltrials.gov .
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-###24797228
-BACKGROUND	Surgical site infection ( SSI ) is a serious complication after pancreaticoduodenectomy ( PD ) .
-BACKGROUND	To prevent microbial colonization of suture material in operative wounds , triclosan-coated polyglactin sutures with antibacterial activity have been developed recently .
-BACKGROUND	Several clinical studies have shown that the use of such suture reduces SSIs in various operations , but its efficacy in PD has not been studied .
-BACKGROUND	We evaluated whether the incidence of SSI can be reduced when triclosan-coated sutures are used for abdominal incision closure after PD .
-METHODS	This controlled clinical trial took place between December 2005 and February 2012 with a total of 198 consecutive patients who had undergone PD .
-METHODS	The study group received triclosan-coated polyglactin 910 antimicrobial sutures between March 2009 and February 2012 , and the control group received conventional wound closure between January 2005 and February 2009 .
-METHODS	We compared the rate and types of infections in the two groups .
-RESULTS	In the study group , age , the incidence of diabetes mellitus , smoking history , and operating time were significantly greater than in the control group .
-RESULTS	The rates of SSI were 4.5 % in the study group and 14.5 % in the control group ( p = 0.037 ) .
-CONCLUSIONS	The use of triclosan-coated sutures may help reduce the incidence of SSI after PD compared with conventional non-antibiotic sutures .
-
-###24880194
-OBJECTIVE	The aim of this study was to compare the results of ultrasonographically guided axillary nerve block ( ANB ) combined with suprascapular nerve block ( SSNB ) with those of SSNB alone on postoperative pain and satisfaction within the first 48hours after arthroscopic rotator cuff repair .
-METHODS	Forty-two patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled in this study .
-METHODS	Among them , 21 patients were randomly allocated to group 1 and received both SSNB and ANB with 10mL ropivacaine .
-METHODS	The other 21 patients were allocated to group 2 and received SSNB with 10mL 0.75 % ropivacaine and ANB with 10mL saline .
-METHODS	Visual analog scale ( VAS ) pain score , patient satisfaction ( SAT ) , and lateral pain index ( LPI ) was checked at 1 , 3 , 6 , 12 , 18 , 24 , 36 , and 48hours postoperatively .
-RESULTS	Group 1 showed a significantly lower mean VAS score at postoperative 1 , 3 , 6 , 12 , 18 , and 24hours compared with group 2 ( 5.1 < 7.6 , 4.4 < 6.3 , 3.7 < 5.3 , 3.2 < 4.5 , 2.7 < 4.0 , and 2.7 < 3.4 , respectively ) .
-RESULTS	A significantly high mean SAT and low mean LPI was observed in group 1 at postoperative 1 , 3 , 6 , 12 , 18 , 24 , and 36hours ( 4.9 > 2.4 , 5.9 > 3.7 , 6.3 > 5.0 , 6.8 > 5.7 , 7.3 > 6.2 , 7.5 > 6.6 , and 7.7 > 7.0 , respectively ) , ( 1.1 < 3.0 , 0.8 < 2.5 , 0.7 < 2.0 , 0.7 < 1.6 , 0.6 < 1.3 , 0.6 < 1.0 , and 0.4 < 0.7 , respectively ) .
-RESULTS	The frequency of rebound pain decreased in group 1 compared with group 2 ( P = .032 ) .
-RESULTS	In addition , rebound phenomenon showed a correlation with ANB on univariate logistic regression ( P = .034 ; odds ratio , 0.246 ) .
-CONCLUSIONS	Ultrasonographically guided ANB combined with SSNB in arthroscopic rotator cuff repair showed an improved mean VAS in the first 24hours after surgery compared with SSNB alone .
-CONCLUSIONS	The mean SAT and LPI of the combined blocks were better than those of the single block within the first 36hours .
-CONCLUSIONS	Ultrasonographically guided ANB combined with SSNB also decreased the rebound phenomenon .
-METHODS	Level I , randomized controlled trial .
-
-###24582111
-OBJECTIVE	The aim of this study was to compare the effect of sevoflurane and propofol on cerebral oxygenation , using regional cerebral oxygen saturation ( SrO2 ) measured by near-infrared spectroscopy ( NIRS ) .
-METHODS	Prospective , randomized , controlled study .
-METHODS	Fifty-four patients aged between 18 and 65 years who underwent elective minor surgery ( tumorectomy for breast cancer or inguinal hernia repair ) were randomly assigned to receive sevoflurane or propofol anaesthesia .
-METHODS	Exclusion criteria included pre-existing cerebrovascular diseases , anaemia , ASA > III , blood loss 200 mL , arterial hypotension , baseline pulse oximetry < 97 % , sign of sensor low quality of SrO2 or bispectral index , and patients with a forehead area < 6.5 cm .
-METHODS	SrO2 , bispectral index , haemodynamic data and anaesthetic doses were recorded during surgery .
-RESULTS	A total of 48 patients were included in the final analysis ( 24 in each group ) .
-RESULTS	There were no significant differences in mean , minimum and maximum SrO2 between sevoflurane and propofol groups .
-RESULTS	The relative maximum decrease was higher in propofol anaesthesia than sevoflurane anaesthesia ( 9.610.7 versus 4.27.2 % ; P = 0.048 ) .
-RESULTS	Cerebral desaturation ( 20 % reduction from SrO2 baseline during 15 seconds ) occurred in 4 patients in propofol group exclusively ( P = 0.109 ) .
-RESULTS	SrO2 adjusted for baseline was higher in the sevoflurane group than in the propofol group ( 67.31.8 % versus 64.21.7 % ; P = 0.018 ) .
-RESULTS	There were no significant differences in haemodynamic parameters between the two groups .
-CONCLUSIONS	Cerebral cortical oxygenation measured by NIRS may be better preserved with sevoflurane than with propofol .
-CONCLUSIONS	These findings suggest that sevoflurane anaesthesia could be a good option in patients with compromised cerebral oxygenation , given the absence of intracranial hypertension .
-CONCLUSIONS	Further studies with larger sample sizes are required to support our results .
-
-###24268702
-OBJECTIVE	To assess long-term effects of laparoscopic electrocautery of the ovaries compared with ovulation induction with gonadotropins in women with clomiphene citrate ( CC ) - resistant polycystic ovary syndrome ( PCOS ) on the incidence of pregnancy complications like gestational diabetes , hypertensive disorders , and metabolic or cardiovascular disease .
-METHODS	Long-term follow-up study .
-METHODS	Twenty-eight hospitals within the Netherlands .
-METHODS	One hundred sixty-eight CC-resistant women who had participated in a randomized controlled trial between 1998 and 2001 comparing electrocautery and gonadotropins .
-METHODS	Postal questionnaire , search in medical files .
-METHODS	Pregnancy complications , metabolic or cardiovascular disease .
-RESULTS	Eighty-two percent of follow-up data were obtained .
-RESULTS	Thirteen of 68 women ( 19 % ) allocated to electrocautery , and 14 of 63 women ( 22 % ) allocated to gonadotropins had evidence for pregnancy complications ( relative risk 0.86 ; 95 % confidence interval 0.43-1 .7 ) .
-RESULTS	At follow-up , 12 of 69 ( 17 % ) women allocated to electrocautery , and 13 of 69 ( 19 % ) women allocated to gonadotropins had evidence for metabolic or cardiovascular disease ( relative risk 0.90 ; 95 % confidence interval 0.39-2 .1 ) .
-RESULTS	The risk of these was modified by body mass index ( BMI ) , but not by female age or treatment allocation .
-RESULTS	This study is based on questionnaires and data from medical files .
-RESULTS	In the absence of routine screening , under-reporting in our follow-up study is likely .
-CONCLUSIONS	Electrocautery in women with CC-resistant PCOS does not affect pregnancycomplications or metabolic or cardiovascular disease later in life compared with ovulation induction with gonadotropins .
-
-###25688605
-OBJECTIVE	To describe the current extent and type of pharmaceutical marketing in nursing homes ( NHs ) in one state and to provide preliminary evidence for the potential influence of pharmaceutical marketing on the use of atypical antipsychotics in NHs .
-METHODS	Nested mixed-methods , cross-sectional study of NHs in a cluster randomized trial .
-METHODS	Forty-one NHs in Connecticut .
-METHODS	NH administrators , directors of nursing , and medical directors ( n = 93 , response rate 75.6 % ) .
-METHODS	Quantitative data , including prescription drug dispensing data ( September 2009-August 2010 ) linked with Nursing Home Compare data ( April 2011 ) , were used to determine facility-level prevalence of atypical antipsychotic use , facility-level characteristics , NH staffing , and NH quality .
-METHODS	Qualitative data , including semistructured interviews and surveys of NH leaders conducted in the first quarter of 2011 , were used to determine encounters with pharmaceutical marketing .
-RESULTS	Leadership at 46.3 % of NHs ( n = 19 ) reported pharmaceutical marketing encounters , consisting of educational training , written and Internet-based materials , and sponsored training .
-RESULTS	No association was detected between level of atypical antipsychotic prescribing and reports of any pharmaceutical marketing by at least one NH leader .
-CONCLUSIONS	NH leaders frequently encounter pharmaceutical marketing through a variety of ways , although the impact on atypical antipsychotic prescribing is unclear .
-
-###24911427
-OBJECTIVE	To evaluate anthropometric measures and serum markers of myostatin-pathway activity after different weight-reduction protocols in wrestlers .
-METHODS	Subjects were randomly assigned to a gradual-weight-reduction ( GWR ) or rapid-weight-reduction ( RWR ) group .
-METHODS	Food logs were collected for the duration of the study .
-METHODS	Anthropometric measurements and serum samples were collected after an 8-h fast at baseline and after the weight-reduction intervention .
-METHODS	Subjects reduced body mass by 4 % .
-METHODS	The GWR group restricted calories over 12 d , while the RWR group restricted calories over 2 d.
-METHODS	A series of 25 repeated-measures ( RM ) ANOVAs was conducted to examine differences in nutrient consumption , while separate 22 RM ANOVAs were conducted to examine differences in anthropometric measures and serum markers .
-METHODS	When applicable , Tukey post hoc comparisons were conducted .
-METHODS	Significance for all tests was set at P < .05 .
-RESULTS	There were no between-groups differences for any anthropometric measure ( P > .05 ) .
-RESULTS	Subjects in both groups experienced a significant reduction in body mass , fat mass , lean mass , and percent body fat ( P < .05 ) .
-RESULTS	There were no between-groups differences in serum markers of myostatin-pathway activity ( P > .05 ) , but subjects in the RWR condition experienced a significant increase in serum myostatin ( P < .01 ) , a decrease in follistatin ( P < .01 ) , and an increase in myostatin-to-follistatin ratio ( P < .001 ) .
-CONCLUSIONS	Although there were no between-groups differences for any outcome variables , the serum myostatin-to-follistatin ratio was significantly increased in the RWR group , possibly signaling the early stages of skeletal-muscle catabolism .
-
-###25539672
-BACKGROUND	Barrett 's oesophagus ( BE ) is a pre-malignant condition leading to oesophageal adenocarcinoma ( OAC ) .
-BACKGROUND	Treatment of neoplasia at an early stage is desirable .
-BACKGROUND	Combined endoscopic mucosal resection ( EMR ) followed by radiofrequency ablation ( RFA ) is an alternative to surgery for patients with BE-related neoplasia .
-METHODS	We examined prospective data from the UK registry of patients undergoing RFA/EMR for BE-related neoplasia from 2008 to 2013 .
-METHODS	Before RFA , visible lesions were removed by EMR .
-METHODS	Thereafter , patients had RFA 3-monthly until all BE was ablated or cancer developed ( endpoints ) .
-METHODS	End of treatment biopsies were recommended at around 12months from first RFA treatment or when endpoints were reached .
-METHODS	Outcomes for clearance of dysplasia ( CR-D ) and BE ( CR-IM ) at end of treatment were assessed over two time periods ( 2008-2010 and 2011-2013 ) .
-METHODS	Durability of successful treatment and progression to OAC were also evaluated .
-RESULTS	508 patients have completed treatment .
-RESULTS	CR-D and CR-IM improved significantly between the former and later time periods , from 77 % and 56 % to 92 % and 83 % , respectively ( p < 0.0001 ) .
-RESULTS	EMR for visible lesions prior to RFA increased from 48 % to 60 % ( p = 0.013 ) .
-RESULTS	Rescue EMR after RFA decreased from 13 % to 2 % ( p < 0.0001 ) .
-RESULTS	Progression to OAC at 12months is not significantly different ( 3.6 % vs 2.1 % , p = 0.51 ) .
-CONCLUSIONS	Clinical outcomes for BE neoplasia have improved significantly over the past 6years with improved lesion recognition and aggressive resection of visible lesions before RFA .
-CONCLUSIONS	Despite advances in technique , the rate of cancer progression remains 2-4 % at 1year in these high-risk patients .
-BACKGROUND	ISRCTN93069556 .
-
-###24283167
-OBJECTIVE	To compare maternal and neonatal oxygenation and acid-base status after elective cesarean section ( CS ) under different anesthetic techniques .
-METHODS	Three hundred and eighty parturients undergoing elective cesarean section were randomly assigned to receive general ( GA , n = 140 ) , epidural ( EA , n = 117 ) or subarachnoid anesthesia ( SA , n = 123 ) .
-METHODS	Blood gases , oxygen content , and acid-base status parameters were measured in maternal artery and umbilical cord vessels .
-METHODS	Neonatal Apgar scores were also recorded .
-RESULTS	Umbilical artery pH , HCO3 - , and actual base excess ( ABE ) were significantly higher in the GA compared to SA group ( p < 0.001 , p < 0.05 , andp < 0.05 , respectively ) .
-RESULTS	Umbilical vein ABE was lower in the SA compared to GA and EA groups ( p < 0.05 ) .
-RESULTS	Oxygen content in maternal artery was higher in the GA and EA groups compared to the SA group ( p < 0.05 ) .
-RESULTS	Neonatal oxygen content in both cord vessels was higher in the GA group compared to EA and SA groups ( p < 0.05 ) .
-RESULTS	Umbilical venous-arterial difference of PO2 , oxygen content , and Apgar scores did not differ significantly among groups .
-CONCLUSIONS	Neonatal oxygenation and acid-base status values were better preserved when GA was administered for elective CS compared to regional modalities .
-CONCLUSIONS	Apgar scores and neonatal outcomes were not affected by the anesthetic technique .
-
-###25782985
-BACKGROUND	Early studies showed beneficial effects of phosphodiesterase 5 inhibitors on cardiovascular function in heart failure ( HF ) patients , but the RELAX trial observed no improvement in exercise capacity with sildenafil treatment in subjects with HF and preserved ejection fraction .
-RESULTS	A subgroup of participants in the RELAX trial ( n = 48 ) underwent comprehensive noninvasive cardiovascular assessment before and after treatment with sildenafil or placebo in a prospective ancillary study .
-RESULTS	Left ventricular contractility was assessed by peak power index and stroke work index .
-RESULTS	Systemic arterial load was assessed by arterial elastance ( Ea ) and right ventricular afterload by pulmonary artery systolic pressure .
-RESULTS	Endothelial function was assessed by reactive hyperemia index after upper arm cuff occlusion .
-RESULTS	Compared with placebo ( n = 25 ) , sildenafil ( n = 23 ) decreased Ea ( -0.290.28 mm Hg/mL versus +0.020.29 , P = 0.008 ) and tended to improve reactive hyperemia index ( +0.300.45 versus -0.170.30 , P = 0.054 ) .
-RESULTS	In contrast , left ventricular contractility was reduced by 11 % to 16 % with sildenafil compared with placebo ( PWR/EDV -5270 versus +040 mm Hg/s , P = 0.006 ; SW/EDV +0.35.8 versus -6.05.1 mm Hg , P = 0.04 ) .
-RESULTS	Sildenafil had no effect on pulmonary artery systolic pressure .
-CONCLUSIONS	In subjects with HF and preserved ejection fraction , sildenafil displayed opposing effects on ventricular and vascular function .
-CONCLUSIONS	We speculate that beneficial effects of phosphodiesterase 5 inhibitors in the systemic vasculature and endothelium were insufficient to improve clinical status or that the deleterious effects on left ventricular function offset any salutary vascular effects , contributing to the absence of benefit observed with sildenafil in subjects with HF and preserved ejection fraction in the RELAX trial .
-BACKGROUND	URL : http://www.clinicaltrials.gov .
-BACKGROUND	Unique identifier : NCT00094302 .
-
-###24565387
-OBJECTIVE	Evaluate the ability of clonidine to reduce pulmonary arterial pressure in patients with pulmonary hypertension undergoing heart surgery , either by reducing the pressure values from the direct measurement of pulmonary arterial pressure or by reducing or eliminating the need for intraoperative dobutamine and nitroprusside .
-METHODS	Randomized , double-blind , placebo-controlled , comparative study conducted in 30 patients with pulmonary arterial hypertension type 2 undergoing cardiac surgery .
-METHODS	Mean pulmonary arterial pressure and dosage of dobutamine and sodium nitroprusside were assessed four times : before intravenous administration of clonidine ( 2 g/kg ) or placebo ( T0 ) , 30 min after tested treatment and before cardiopulmonary bypass ( T1 ) , immediately after CPB ( T2 ) , 10 min after protamine injection ( T3 ) .
-RESULTS	There were no significant differences regarding mean pulmonary arterial pressure at any time of evaluation .
-RESULTS	There was no significant difference between groups regarding other variables , such as mean systemic arterial pressure , heart rate , total dose of dobutamine , total dose of sodium nitroprusside , and need for fentanyl .
-CONCLUSIONS	Data analysis from patients included in this study allows us to conclude that intravenous clonidine ( 2 g/kg ) was not able to reduce the mean pulmonary arterial pressure in patients with pulmonary hypertension in group 2 ( pulmonary venous hypertension ) , undergoing heart surgery , or reduce or eliminate the need for intraoperative administration of dobutamine and sodium nitroprusside .
-
-###25266473
-OBJECTIVE	The primary aim of this pilot study was to evaluate the possible therapeutic effects of a 10-session humor intervention program in improving rehabilitative outcomes and the effects of the intervention on patients ' sense of humor among patients with schizophrenia .
-METHODS	Thirty subjects were randomly assigned into either the intervention ( humor skill training ) group ( n = 15 ) or the control ( doing handwork ) group ( n = 15 ) .
-METHODS	The results were analyzed using descriptive statistics , t-tests and ANOVA .
-RESULTS	Repeated measures analysis of variance ( ANOVA ) tests were conducted to examine the differences across conditions and time .
-RESULTS	A group by time interaction effect was observed on all of the outcomes , except positive symptoms of PANSS .
-RESULTS	The time main effect was also significant on the total score ( p < 0.005 ) and the negative symptoms score ( p < 0.001 ) of the PANSS .
-CONCLUSIONS	The implementation of humor skill training in a mental health service can improve rehabilitative outcomes and sense of humor for schizophrenia patients who were in the rehabilitation stage .
-
-###24550581
-OBJECTIVE	Levosimendan is a calcium sensitizer drug which has been used in cardiac surgery for the prevention of postoperative low cardiac output syndrome ( LCOS ) and in difficult weaning from cardiopulmonary bypass ( CPB ) .
-OBJECTIVE	This study aims to evaluate perioperative hemodynamic effects of levosimendan pretreatment in patients for off-pump coronary artery bypass graft ( OPCABG ) surgery with low left ventricular ejection fractions ( LVEF < 30 % ) .
-METHODS	Fifty patients undergoing OPCABG surgery with low LVEF ( < 30 % ) were enrolled in the study .
-METHODS	Patients were randomly divided in two groups : Levosimendan pretreatment ( Group L ) and placebo pretreatment ( Group C ) of 25 each .
-METHODS	Group L , patients received levosimendan infusion 200 g/kg over 24 h and in Group C Patients received placebo .
-METHODS	The clinical parameters measured before and after the drug administration up to 48 h were heart rate ( HR ; for the hour after drug infusion ) , cardiac index ( CI ) , and pulmonary capillary wedge pressure ( PCWP ) .
-METHODS	The requirement of inotropes , intraaortic balloon pump ( IABP ) , CPB , intensive care unit ( ICU ) stay , and hospital stay were also measured .
-RESULTS	The patients in group L exhibited higher CI and PCWP during operative in early postoperative period as compared to control group C. Group L also had a less requirement for inotropes , CPB support and IABP with shorter ICU stay as well as hospital stay .
-CONCLUSIONS	Levosimendan pretreatment ( 24 h infusion ) in patient for OPCABG with poor LVEF shows better outcomes and hemodynamics in terms of inotropes , CPB and IABP requirements .
-CONCLUSIONS	It also reduces ICU stay .
-
-###25410648
-OBJECTIVE	Both 2-L polyethylene glycol with ascorbic acid ( 2-L PEG/Asc ) and sodium picosulfate with magnesium citrate ( SP/MC ) are low-volume combined agents for colonic preparation .
-OBJECTIVE	The aim of the current study was to compare the preparation adequacy and patient tolerability of 2-L PEG/Asc and SP/MC .
-METHODS	We performed a prospective randomized controlled study in outpatients undergoing daytime colonoscopy at a tertiary academic hospital .
-METHODS	We compared preparation adequacy based on the Boston Bowel Preparation Scale ( BBPS ) , polyp and adenoma detection rate ( PDR and ADR ) , compliance , tolerability for ease and palatability , intention to reuse , and patient satisfaction using a questionnaire between 2-L PEG/Asc and three sachets of SP/MC , both given in a split-dose method .
-RESULTS	A total of 388 patients were evaluated based on intention to treat ( ITT ) and 356 patients per protocol ( PP ) .
-RESULTS	No significant differences in preparation adequacy were observed in ITT and PP analyses , based on the BBPS ( p > 0.05 ) .
-RESULTS	The PDR and ADR were greater than 60 and 40 % in both groups , respectively ( p > 0.05 ) .
-RESULTS	Compliance levels were higher in the 2-L PEG/Asc group than in the SP/MC group ( p < 0.001 ) .
-RESULTS	Satisfaction ( ITT , p = 0.014 ; PP , p = 0.032 ) and palatability ( ITT and PP , p < 0.001 ) levels were higher in the SP/MC group than in the 2-L PEG/Asc group , but values for tolerability for ease and intention to reuse were similar in both groups ( ITT and PP , p > 0.05 ) .
-CONCLUSIONS	Both 2-L PEG/Asc and SP/MC had adequate bowel cleansing efficacy to satisfy PDR and ADR as quality indicator and had showed similar tolerability .
-
-###24626733
-OBJECTIVE	To determine the safety , pain intensity correlated with age and body mass index ( BMI ) , epidural anesthesia with ropivacaine and clonidine in hemorrhoidectomy .
-METHODS	Eighty patients , both genders , 20-70 years old , ASA I or II , for hemorrhoidectomy were randomly divided into two groups : Control ( n = 38 ) , epidural anesthesia with 14 mL of ropivacaine 0.75 % plus 0.0266 mL/kg of 0.9 % saline solution ; Experimental ( n = 42 ) epidural anesthesia with 14 mL of 0.75 % ropivacaine plus 4.0 mcg/kg of clonidine .
-METHODS	In preoperative and postoperative period were evaluated : systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , heart rate ( HR ) , pulse oximetry ( SpO2 ) , electrocardiography ( ECG ) , pain intensity ( VAS ) in four , eight and , 12 hours and analgesic consumption .
-RESULTS	The VAS values differed between four , eight and 12 hours in the Experimental Group , where correlation of VAS 12h with age ( p < 0.05 ) occurred and not with BMI and more patients ( p < 0.05 ) did not receive analgesics .
-RESULTS	SBP , DBP , HR changed similarly in both groups at 15 , 30 and 45 min .
-RESULTS	The ECG and SpO2 remained unchanged .
-CONCLUSIONS	Clonidine ( 4mcg/kg ) in epidural anesthesia with ropivacaine 0.75 % in hemorrhoidectomy showed safety and greater analgesia within four hours .
-CONCLUSIONS	The pain at 12 hours showed correlation with age and not with body mass index .
-
-###26165528
-BACKGROUND	High-concentration normobaric oxygen ( O ) administration is the first-aid priority in treating divers with suspected decompression illness .
-BACKGROUND	The best O delivery device and flow rate are yet to be determined .
-OBJECTIVE	To determine whether administering O with a non-rebreather mask ( NRB ) at a flow rate of 10 or 15 Lmin or with a demand valve with oronasal mask significantly affects the tissue partial pressure of O ( PtcO ) in healthy volunteer scuba divers .
-METHODS	Fifteen certified scuba divers had PtcO measured at six positions on the arm and leg .
-METHODS	Measurements were taken with subjects lying supine whilst breathing O from a NRB at 10 or 15Lmin , a demand valve with an adult Tru-Fit oronasal mask and , as a reference standard , an oxygen ` head hood ' .
-METHODS	End-tidal carbon dioxide was also measured .
-RESULTS	While none of the emergency delivery devices performed as well as the head hood , limb tissue oxygenation was greatest when O was delivered via the NRB at 15 Lmin .
-RESULTS	There were no clinically significant differences in end-tidal carbon dioxide regardless of the delivery device or flow rate .
-CONCLUSIONS	Based on transcutaneous oximetry values , of the commonly available emergency O delivery devices , the NRB at 15 Lmin is the device and flow rate that deliver the most O to body tissues and , therefore , should be considered as a first-line pre-hospital treatment in divers with suspected decompression illness .
-
-###25930719
-BACKGROUND	Postmenopausal women with breast cancer receiving aromatase inhibitors are at an increased risk of bone loss .
-BACKGROUND	The current study was undertaken to determine whether upfront versus delayed treatment with zoledronic acid ( ZA ) impacted bone loss .
-BACKGROUND	This report described the 5-year follow-up results .
-METHODS	A total of 551 postmenopausal women with breast cancer who completed tamoxifen treatment and were undergoing daily letrozole treatment were randomized to either upfront ( 274 patients ) or delayed ( 277 patients ) ZA at a dose of 4 mg intravenously every 6 months .
-METHODS	In the patients on the delayed treatment arm , ZA was initiated for a postbaseline bone mineral density T-score of < -2.0 or fracture .
-RESULTS	The incidence of a 5 % decrease in the total lumbar spine bone mineral density at 5 years was 10.2 % in the upfront treatment arm versus 41.2 % in the delayed treatment arm ( P < .0001 ) .
-RESULTS	A total of 41 patients in the delayed treatment arm were eventually started on ZA .
-RESULTS	With the exception of increased NCI Common Toxicity Criteria ( CTC ) grade 1/2 elevated creatinine and fever in the patients treated on the upfront arm and cerebrovascular ischemia among those in the delayed treatment arm , there were no significant differences observed between arms with respect to the most common adverse events of arthralgia and back pain .
-RESULTS	Osteoporosis occurred less frequently in the upfront treatment arm ( 2 vs 8 cumulative cases ) , although this difference was not found to be statistically significant .
-RESULTS	Bone fractures occurred in 24 patients in the upfront treatment arm versus 25 patients in the delayed treatment arm .
-CONCLUSIONS	Immediate treatment with ZA prevented bone loss compared with delayed treatment in postmenopausal women receiving letrozole and these differences were maintained at 5 years .
-CONCLUSIONS	The incidence of osteoporosis or fractures was not found to be significantly different between treatment arms .
-
-###24762413
-OBJECTIVE	The Neonatal Resuscitation Program ( NRP ) has transitioned to a simulation-based format .
-OBJECTIVE	We hypothesized that immersive simulation differentially impacts similar trainee populations ' resuscitation knowledge , procedural skill and teamwork behavior .
-METHODS	Residents from NICU and non-NICU programs were randomized to either control or a booster simulation 7 to 10 months after NRP .
-METHODS	Procedural skill and teamwork behavior instruments were validated .
-METHODS	Individual resident 's resuscitation performance was assessed at 15 to 18 months .
-METHODS	Three reviewers rated videos .
-RESULTS	Fifty residents were assessed .
-RESULTS	Inter-rater reliability was good for procedural skills ( 0.78 ) and team behavior ( 0.74 ) instruments .
-RESULTS	The intervention group demonstrated better procedural skills ( 71.6 versus 64.4 ) and teamwork behaviors ( 18.8 versus 16.2 ) .
-RESULTS	The NICU program demonstrated better teamwork behaviors ( 18.6 versus 15.5 ) compared with non-NICU program .
-CONCLUSIONS	A simulation-enhanced booster session 9 months after NRP differentiates procedural skill and teamwork behavior at 15 months .
-CONCLUSIONS	Deliberate practice with simulation enhances teamwork behaviors additively with residents ' clinical resuscitation exposure .
-
-###26164864
-BACKGROUND	Multifactor heart failure is a common life-threatening event in elderly patients and often complicated by concomitant hypertension and diabetes mellitus ( DM ) .
-BACKGROUND	The aim of this study was to evaluate whether 1-blocker , urapidil , provides additional therapeutic benefits compared to nitroglycerin ( NG ) in treatment of multifactor heart failure complicated by hypertension and DM in elderly patients .
-METHODS	Seventy-two elderly consecutive patients were randomized into 2 groups that received treatment with urapidil or NG .
-METHODS	All patients were monitored for blood pressure ( BP ) and heart rate and received tests for metabolic activity and cardiovascular function .
-RESULTS	Patients receiving urapidil had significantly lower systolic BP than their counterparts in NG group ( P < 0.05 ) .
-RESULTS	Moreover , patients in urapidil group showed lower N-terminal pro-B-type natriuretic peptide levels but higher ejection fraction ( t = 2.206 , P < 0.05 ) , cardiac index ( t = 3.13 , P < 0.05 ) and left end-diastolic volume ( t = -3.104 , P < 0.05 ) compared to NG group .
-RESULTS	Although both urapidil and NG decreased fasting plasma glucose ( FPG ) levels , there was no significant difference of FPG levels between these 2 groups .
-CONCLUSIONS	Urapidil demonstrated better efficacy than NG on lowering and stabilizing systolic BP , attenuating cardiac afterload and improving cardiac function .
-CONCLUSIONS	Both NG and urapidil significantly reduced FPG levels in multifactor heart failure patients with DM .
-CONCLUSIONS	Urapidil is a therapeutic option for the multifactor heart failure patients complicated with hypertension and DM .
-
-###25065692
-BACKGROUND	Meta-analyses suggest that reboxetine may be less effective than other antidepressants .
-BACKGROUND	Such comparisons may be biased by lower adherence to reboxetine and subsequent handling of missing outcome data .
-BACKGROUND	This study illustrates how to adjust for differential non-adherence and hence derive an unbiased estimate of the efficacy of reboxetine compared with citalopram in primary care patients with depression .
-METHODS	A structural mean modelling ( SMM ) approach was used to generate adherence-adjusted estimates of the efficacy of reboxetine compared with citalopram using GENetic and clinical Predictors Of treatment response in Depression ( GENPOD ) trial data .
-METHODS	Intention-to-treat ( ITT ) analyses were performed to compare estimates of effectiveness with results from previous meta-analyses .
-RESULTS	At 6 weeks , 92 % of those randomized to citalopram were still taking their medication , compared with 72 % of those randomized to reboxetine .
-RESULTS	In ITT analysis , there was only weak evidence that those on reboxetine had a slightly worse outcome than those on citalopram [ adjusted difference in mean Beck Depression Inventory ( BDI ) scores : 1.19 , 95 % confidence interval ( CI ) -0.52 to 2.90 , p = 0.17 ] .
-RESULTS	There was no evidence of a difference in efficacy when differential non-adherence was accounted for using the SMM approach for mean BDI ( -0.29 , 95 % CI -3.04 to 2.46 , p = 0.84 ) or the other mental health outcomes .
-CONCLUSIONS	There was no evidence of a difference in the efficacy of reboxetine and citalopram when these drugs are taken and tolerated by depressed patients .
-CONCLUSIONS	The SMM approach can be implemented in standard statistical software to adjust for differential non-adherence and generate unbiased estimates of treatment efficacy for comparisons of two ( or more ) active interventions .
-
-###25901427
-BACKGROUND	Alcoholic hepatitis is a clinical syndrome characterized by jaundice and liver impairment that occurs in patients with a history of heavy and prolonged alcohol use .
-BACKGROUND	The short-term mortality among patients with severe disease exceeds 30 % .
-BACKGROUND	Prednisolone and pentoxifylline are both recommended for the treatment of severe alcoholic hepatitis , but uncertainty about their benefit persists .
-METHODS	We conducted a multicenter , double-blind , randomized trial with a 2-by-2 factorial design to evaluate the effect of treatment with prednisolone or pentoxifylline .
-METHODS	The primary end point was mortality at 28 days .
-METHODS	Secondary end points included death or liver transplantation at 90 days and at 1 year .
-METHODS	Patients with a clinical diagnosis of alcoholic hepatitis and severe disease were randomly assigned to one of four groups : a group that received a pentoxifylline-matched placebo and a prednisolone-matched placebo , a group that received prednisolone and a pentoxifylline-matched placebo , a group that received pentoxifylline and a prednisolone-matched placebo , or a group that received both prednisolone and pentoxifylline .
-RESULTS	A total of 1103 patients underwent randomization , and data from 1053 were available for the primary end-point analysis .
-RESULTS	Mortality at 28 days was 17 % ( 45 of 269 patients ) in the placebo-placebo group , 14 % ( 38 of 266 patients ) in the prednisolone-placebo group , 19 % ( 50 of 258 patients ) in the pentoxifylline-placebo group , and 13 % ( 35 of 260 patients ) in the prednisolone-pentoxifylline group .
-RESULTS	The odds ratio for 28-day mortality with pentoxifylline was 1.07 ( 95 % confidence interval [ CI ] , 0.77 to 1.49 ; P = 0.69 ) , and that with prednisolone was 0.72 ( 95 % CI , 0.52 to 1.01 ; P = 0.06 ) .
-RESULTS	At 90 days and at 1 year , there were no significant between-group differences .
-RESULTS	Serious infections occurred in 13 % of the patients treated with prednisolone versus 7 % of those who did not receive prednisolone ( P = 0.002 ) .
-CONCLUSIONS	Pentoxifylline did not improve survival in patients with alcoholic hepatitis .
-CONCLUSIONS	Prednisolone was associated with a reduction in 28-day mortality that did not reach significance and with no improvement in outcomes at 90 days or 1 year .
-CONCLUSIONS	( Funded by the National Institute for Health Research Health Technology Assessment program ; STOPAH EudraCT number , 2009-013897-42 , and Current Controlled Trials number , ISRCTN88782125 ) .
-
-###24742740
-BACKGROUND	The combination of stent insertion and single high-dose brachytherapy is a feasible and safe palliative treatment regimen in patients with unresectable oesophageal cancer .
-BACKGROUND	We aimed to further assess the efficacy of this treatment strategy compared to a conventional covered stent in patients with dysphagia caused by unresectable oesophageal cancer .
-METHODS	In this multicentre , single-blind , randomised , phase 3 trial , we enrolled patients with unresectable oesophageal cancer from 16 hospitals in China .
-METHODS	We included adult patients ( aged 20 years ) with progressive dysphagia , unresectable tumours due to extensive lesions , metastases , or poor medical condition , and with clear consciousness , cooperation , and an Eastern Cooperative Oncology Group ( ECOG ) performance status score of 0-3 .
-METHODS	Eligible patients were randomly assigned ( in 1:1 ratio , no stratification ) to receive either a stent loaded with ( 125 ) iodine radioactive seeds ( irradiation group ) or a conventional oesophageal stent ( control group ) .
-METHODS	The primary endpoint was overall survival .
-METHODS	Survival analyses were done in a modified intention-to-treat group .
-METHODS	This study is registered with ClinicalTrials.gov , number NCT01054274 .
-RESULTS	Between Nov 1 , 2009 , and Oct 31 , 2012 , 160 patients were randomly assigned to receive treatment with either an irradiation stent ( n = 80 ) or a conventional stent ( n = 80 ) .
-RESULTS	During a median follow-up of 138 days ( IQR 72-207 ) , 148 stents ( 73 in the irradiation group and 75 in the control group ) were successfully placed into the diseased oesophagus in 148 participants .
-RESULTS	Median overall survival was 177 days ( 95 % CI 153-201 ) in the irradiation group versus 147 days ( 124-170 ) in the control group ( p = 0.0046 ) .
-RESULTS	Major complications and side-effects of the treatment were severe chest pain ( 17 [ 23 % ] of 73 patients in the irradiation group vs 15 [ 20 % ] of 75 patents in the control group ) , fistula formation ( six [ 8 % ] vs five [ 7 % ] ) , aspiration pneumonia ( 11 [ 15 % ] vs 14 [ 19 % ] ) , haemorrhage ( five [ 7 % ] vs five [ 7 % ] ) , and recurrent dysphagia ( 21 [ 28 % ] vs 20 [ 27 % ] ) .
-CONCLUSIONS	In patients with unresectable oesophageal cancer , the insertion of an oesophageal stent loaded with ( 125 ) iodine seeds prolonged survival when compared with the insertion of a conventional covered self-expandable metallic stent .
-
-###24751173
-BACKGROUND	Participation in organised youth sports ( OYS ) has been recommended as an opportunity to increase young peoples ' moderate-to-vigorous physical activity ( MVPA ) levels .
-BACKGROUND	Participants , however , spend a considerable proportion of time during OYS inactive .
-BACKGROUND	The purpose of this study , therefore , was to investigate whether coaches who attended coach education sessions ( where education on increasing MVPA and decreasing inactivity during training was delivered ) can increase players ' MVPA during training sessions over a 5-day basketball program compared to coaches who did not receive coach education sessions .
-METHODS	A convenience sample of 80 female players and 8 coaches were recruited into the UWS School Holiday Basketball Program in Greater Western Sydney , Australia .
-METHODS	A two-arm , parallel-group randomised controlled trial was employed to investigate whether coaches who attended 2 coach education sessions ( compared with a no-treatment control ) can increase their players ' MVPA during training sessions over a 5-day basketball program .
-METHODS	Objectively measured physical activity , directly observed lesson context and leader behaviour , player motivation , players ' perceived autonomy support , and coaching information ( regarding training session planning , estimations on player physical activity and lesson context during training , perceived ability to modify training sessions , perceived importance of physical activity during training , intention to increase physical activity/reduce inactivity , and likelihood of increasing physical activity/reducing inactivity ) were assessed at baseline ( day 1 ) and at follow-up ( day 5 ) .
-METHODS	Linear mixed models will be used to analyse between arm differences in changes from baseline to follow-up on all outcomes .
-CONCLUSIONS	The current trial protocol describes , to our knowledge , the first trial conducted in an OYS context to investigate the efficacy of an intervention , relative to a control , in increasing MVPA .
-CONCLUSIONS	This study 's findings will provide evidence to inform strategies targeting coaches to increase MVPA in OYS , which could have major public health implications , given the high proportion of children and adolescents who participate in OYS globally .
-BACKGROUND	This trial is registered with the Australian New Zealand Clinical Trials Registry , ACTRN12613001099718 .
-
-###24997634
-BACKGROUND	The beneficial effects of the Mediterranean diet have been amply proven in adults with cardiovascular risk factors .
-BACKGROUND	The effects of this diet have not been extensively assessed in pediatric populations with obesity , insulin resistance ( IR ) and metabolic syndrome ( MetS ) .
-BACKGROUND	The aim of this study was to assess the efficacy of the Mediterranean style diet ( MSD ) to decrease cardiovascular risk factors in children and adolescents with obesity .
-METHODS	Participants were randomly assigned to a MSD rich in polyunsaturated fatty acids , fiber , flavonoids and antioxidants ( 60 % of energy from carbohydrate , 25 % from fat , and 15 % from protein , ( n = 24 ) ; or a standard diet ( 55 % of carbohydrate , 30 % from fat and 15 % from protein , ( n = 25 ) , the caloric ingest was individualized .
-METHODS	At baseline and 16-week of intervention , the glucose , triglycerides ( TG ) , total cholesterol ( TC ) , HDL-C , LDL-C were measured as well as the body composition and anthropometric data .
-METHODS	The diet compliance was determined by the 24-hour recalls.Paired Student 's t and Macnemar 's test were used to compare effects in biochemical , body composition , anthropometric , and dietary variables .
-RESULTS	The MSD group had a significantly decrease in BMI , lean mass , fat mass , glucose , TC , TG , HDL-C and LDL-C .
-RESULTS	( p < 0.05 ) ; the diet compliance increased consumption of omega 9 fatty acids , zinc , vitamin E , selenium , and decreased consumption of saturated fatty acids ( p < 0.05 ) .
-RESULTS	The standard diet group decrease in glucose levels and frequency of glucose > 100 mg/dL ( p < 0.05 ) .
-CONCLUSIONS	The MSD improves the BMI , glucose and lipid profile in children and adolescents with obesity and any MetS component .
-
-###24958780
-BACKGROUND	We sought to characterize growth between birth and age 3 years in infants with hypoplastic left heart syndrome who underwent the Norwood procedure .
-RESULTS	We performed a secondary analysis using the Single Ventricle Reconstruction Trial database after excluding patients < 37 weeks gestation ( N = 498 ) .
-RESULTS	We determined length-for-age z score ( LAZ ) and weight-for-age z score ( WAZ ) at birth and age 3 years and change in WAZ over 4 clinically relevant time periods .
-RESULTS	We identified correlates of change in WAZ and LAZ using multivariable linear regression with bootstrapping .
-RESULTS	Mean WAZ and LAZ were below average relative to the general population at birth ( P < 0.001 , P = 0.05 , respectively ) and age 3 years ( P < 0.001 each ) .
-RESULTS	The largest decrease in WAZ occurred between birth and Norwood discharge ; the greatest gain occurred between stage II and 14 months .
-RESULTS	At age 3 years , WAZ and LAZ were < -2 in 6 % and 18 % , respectively .
-RESULTS	Factors associated with change in WAZ differed among time periods .
-RESULTS	Shunt type was associated with change in WAZ only in the Norwood discharge to stage II period ; subjects with a Blalock-Taussig shunt had a greater decline in WAZ than those with a right ventricle-pulmonary artery shunt ( P = 0.002 ) .
-CONCLUSIONS	WAZ changed over time and the predictors of change in WAZ varied among time periods .
-CONCLUSIONS	By age 3 years , subjects remained small and three times as many children were short as were underweight ( > 2 SD below normal ) .
-CONCLUSIONS	Failure to find consistent risk factors supports the strategy of tailoring nutritional therapies to patient - and stage-specific targets .
-BACKGROUND	http://clinicaltrials.gov/ .
-BACKGROUND	Unique identifier : NCT00115934 .
-
-###24976291
-OBJECTIVE	Fingolimod , a sphingosine 1-phosphate receptor modulator , is the first oral disease modifying therapy approved for the treatment of relapsing multiple sclerosis .
-OBJECTIVE	The aim of this double-blind , placebo-controlled study was to evaluate the effect of fingolimod on cerebral blood flow , platelet function and macular thickness in healthy volunteers .
-METHODS	The study included 88 healthy volunteers who received fingolimod 0.5 mg or 1.25 mg or matched placebo over a period of 4 weeks .
-METHODS	Transcranial colour coded sonography was performed to measure mean blood flow velocities , the platelet function was measured by the PFA-100 assay using a collagen/epinephrine cartridge and macular thickness was measured using optical coherence tomography .
-METHODS	An assessment of non-inferiority of fingolimod vs. placebo was performed against a reference value ( 20 % of the overall baseline value ) .
-RESULTS	All 88 randomized participants completed the study .
-RESULTS	At day 28 compared with baseline value , for 0.5 mg , 1.25 mg and placebo treatments , the mean middle cerebral artery blood flow velocity decreased by 4 , 1 and 3.7 cms ( -1 ) , respectively .
-RESULTS	The platelet function analyzer closure time increase was not significant ( 7.8 , 7.5 and 10.4 s , respectively ) .
-RESULTS	The mean percentage change in the central foveal thickness from baseline for both eyes was below 3 % for all groups .
-RESULTS	The safety profile of fingolimod in this study was found consistent with the previous reports .
-CONCLUSIONS	In healthy volunteers , the changes seen with both fingolimod doses were found to be within normal variability , non-inferior and comparable with those observed with placebo for all the pharmacodynamic parameters assessed .
-
-###25160492
-BACKGROUND	Cancer survivors often experience decreased self-confidence which impacts negatively on their ability to self-manage the practical , social and emotional problems frequently faced as they emerge from end of treatment .
-BACKGROUND	This was a feasibility study of a life-coaching intervention , designed to rebuild confidence of survivors and support transition to life after cancer treatment .
-METHODS	A one group pre-test , post-test design was used , recruiting participants from community organisations .
-METHODS	Eligibility criteria are as follows : < 1 year of completion of primary cancer treatment , aged > 18 , no metastases , and no mental health problems .
-METHODS	Participants received one individualised face-to-face and five telephone coaching sessions over 3 months .
-METHODS	Outcome measures are as follows : New General Self-Efficacy Scale , Hope Scale , Personal Well-being Index , Assessment of Survivorship Concerns , Quality of Life in Adult Cancer Survivors , Hospital Anxiety and Depression Scale , Social Difficulties Index , and a goal attainment score .
-METHODS	Interviews explored feasibility , acceptability and impact of life-coaching and research design .
-RESULTS	Nine women and two men were recruited , representing varying cancer diagnoses .
-RESULTS	All outcome measures were sensitive to change and indicated positive trends post-intervention .
-RESULTS	Participant interviews indicated the intervention was well received and had a positive impact .
-RESULTS	Lessons were learnt about study design , recruitment and intervention delivery .
-CONCLUSIONS	Life-coaching has a potential to enable cancer survivors to manage the transition to life beyond cancer and effect change on a range of outcomes .
-CONCLUSIONS	The intervention was feasible to deliver and acceptable to survivors at a time when many struggle to make sense of life .
-CONCLUSIONS	It merits further evaluation through a randomised controlled trial .
-
-###25178073
-OBJECTIVE	of the study was to assess efficacy of the use of fixed combination of nebivolol and amlodipine in patients with moderate and high degree of arterial hypertension ( AH ) .
-METHODS	Patients with diagnosis of primary AH ( n = 124 ) were divided into 2 groups by random sample method .
-METHODS	Patients of group 1 ( n = 62 ) received of fixed combination of nebivolol and amlodipine , while those of group 2 ( n = 62 ) received free combination of nebivolol and amlodipine .
-METHODS	Study drugs were administered both as initial therapy and replacement of preceding treatment .
-METHODS	Duration of observation was 3 months with visits after first 2 weeks and in 1 , 2 , and 3 months after enrollment .
-RESULTS	Starting from 2nd week visit of fixed combination of nebivolol and amlodipine treated patients had significantly lower levels of systolic and diastolic AP .
-RESULTS	Already after 2 weeks of combined two-component therapy 60 % of group 1 and 52 % of group 2 patients achieved target AP .
-RESULTS	Target AP was achieved by the end of month 1 by 86 and 71 % , of month 2 - by 93 and 78 % of patients in groups 1 and 2 , respectively .
-RESULTS	In 3 months almost all patients had target AP , but in 1.6 % of group 1 and 2.3 % of group 2 patients this level was achieved after addition of a thiazide diuretic .
-RESULTS	Patients receiving of fixed combination of nebivolol and amlodipine achieved noromosyslolia more quickly compared with patients who received free combination of nebivolol and amlodipine .
-CONCLUSIONS	Combined therapy with fixed combination of nebivolol and amlodipine appears to be one of effective approaches to treatment of patients with moderate and high degree AH .
-
-###24417786
-BACKGROUND	CG100649 , a novel selective cyclooxygenase-2 inhibitor that also inhibits carbonic anhydrase I/II , is expected to reduce the cardiovascular risk typical of other NSAIDs .
-BACKGROUND	Concurrent medications may influence the activities of the cytochrome P450 ( CYP ) 3A enzyme through which CG100649 is metabolized .
-OBJECTIVE	This study was designed to evaluate the influence of ketoconazole , a known strong inhibitor of CYP3A , on the pharmacokinetic properties of CG100649 .
-METHODS	This randomized , open-label , 2 2 crossover study was conducted in healthy Korean male volunteers .
-METHODS	Each subject received the following 2 treatments in a randomly allocated sequence , separated by a washout period of 42 days : single oral dose of CG100649 6 mg , and concurrent dosing of CG100649 6 mg and ketoconazole 400 mg followed by ketoconazole 400 mg/d over 4 days .
-METHODS	Blood samples for pharmacokinetic analysis were collected at 0 ( predose ) , 0.5 , 1 , 1.5 , 2 , 3 , 4 , 6 , 8 , 10 , 12 , 24 , 36 , 48 , 72 , 96 , 120 , 144 , 240 , 384 , and 480 hours after dosing of CG100649 in each sequence .
-METHODS	Tolerability assessments were performed throughout the study .
-RESULTS	Thirty subjects participated , and 26 subjects completed the study .
-RESULTS	Seventeen adverse events ( AEs ) were reported in 10 subjects , and all AEs were recovered without any sequelae .
-RESULTS	No serious AEs were reported .
-RESULTS	Six subjects receiving the single dose of CG100649 had 9 AEs , and 7 subjects receiving the combination of ketoconazole and CG100649 had 8 AEs .
-RESULTS	The Cmax of CG100649 with CG100649 only and with concurrent administration of CG100649 + ketoconazole were similar ( 10.7 and 11.0 ng/mL , respectively ) .
-RESULTS	The CG100649 AUClast with concurrent ketoconazole was 1.29-fold greater than that with CG100649 only ( 2074.0 and 2685.8 ng h/mL ) and demonstrated a statistically significant difference ( P < 0.05 ) .
-RESULTS	However , there were no statistically significant differences in vital signs , clinical laboratory test results , ECGs , or AEs between treatments .
-CONCLUSIONS	Although the AUC of CG100649 increased by 29 % with the concurrent medication of ketoconazole , it is considered that concurrent administration of CG100649 with ketoconazole would not change the safety profile of CG100649 .
-
-###25011647
-BACKGROUND	Advanced glycation endproducts ( AGEs ) contribute to the development of vascular complications of diabetes and have been recently implicated in the pathogenesis of diabetes .
-BACKGROUND	Since AGEs are generated within foodstuffs upon food processing , it is increasingly recognised that the modern diet is replete with AGEs .
-BACKGROUND	AGEs are thought to stimulate chronic low-grade inflammation and promote oxidative stress and have been linked to the development of insulin resistance .
-BACKGROUND	Simple therapeutic strategies targeted at attenuating the progression of chronic low-grade inflammation and insulin resistance are urgently required to prevent or slow the development of type 2 diabetes in susceptible individuals .
-BACKGROUND	Dietary modulation of the human colonic microbiota has been shown to confer a number of health benefits to the host , but its effect on advanced glycation is unknown .
-BACKGROUND	The aim of this article is to describe the methodology of a double-blind placebo-controlled randomised crossover trial designed to determine the effect of 12week consumption of a prebiotic dietary supplement on the advanced glycation pathway , insulin sensitivity and chronic low-grade inflammation in adults with pre-diabetes .
-METHODS	Thirty adults with pre-diabetes ( Impaired Glucose Tolerance or Impaired Fasting Glucose ) aged between 40-60 years will be randomly assigned to receive either 10 grams of prebiotic ( inulin/oligofructose ) daily or 10 grams placebo ( maltodextrin ) daily for 12weeks .
-METHODS	After a 2-week washout period , study subjects will crossover to receive the alternative dietary treatment for 12weeks .
-METHODS	The primary outcome is the difference in markers of the advanced glycation pathway carboxymethyllysine ( CML ) and methylglyoxal ( MG ) between experimental and control treatments .
-METHODS	Secondary outcomes include HbA1c , insulin sensitivity , lipid levels , blood pressure , serum glutathione , adiponectin , IL-6 , E-selectin , myeloperoxidase , C-reactive protein , Toll-like Receptor 4 ( TLR4 ) , soluble receptor for AGE ( sRAGE ) , urinary 8-isoprostanes , faecal bacterial composition and short chain fatty acid profile .
-METHODS	Anthropometric measures including BMI and waist circumference will be collected in addition to comprehensive dietary and lifestyle data .
-CONCLUSIONS	Prebiotics which selectively stimulate the growth of beneficial bacteria in the human colon might offer protection against AGE-related pathology in people at risk of developing type 2 diabetes .
-BACKGROUND	Australia and New Zealand Clinical Trials Register ( ANZCTR ) : ACTRN12613000130763 .
-
-###25326750
-BACKGROUND	The 2013 GOLD classification system for COPD distinguishes four stages : A ( low symptoms , low exacerbation risk ) , B ( high symptoms , low risk ) , C ( low symptoms , high risk ) and D ( high symptoms , high risk ) .
-BACKGROUND	Assessment of risk is based on exacerbation history and airflow obstruction , whatever results in a higher risk grouping .
-BACKGROUND	The previous system was solely based on airflow obstruction .
-BACKGROUND	Earlier studies compared the predictive performance of new and old classification systems with regards to mortality and exacerbations .
-BACKGROUND	The objective of this study was to compare the ability of both classifications to predict the number of future ( total and severe ) exacerbations and mortality in a different patient population , and to add an outcome measure to the comparison : lung function decline .
-METHODS	Patient-level data from the UPLIFT trial were used to analyze 4-year survival in a Weibull model , with GOLD stages at baseline as covariates .
-METHODS	A generalized linear model was used to compare the numbers of exacerbations ( total and severe ) per stage .
-METHODS	Analyses were repeated with stages C and D divided into substages depending on lung function and exacerbation history .
-METHODS	Lung function decline was analysed in a repeated measures model .
-RESULTS	Mortality increased from A to D , but there was no difference between B and C. For the previous GOLD stages 2-4 , survival curves were clearly separated .
-RESULTS	Yearly exacerbation rates were : 0.53 , 0.72 and 0.80 for stages 2-4 ; and 0.35 , 0.45 , 0.58 and 0.74 for A-D .
-RESULTS	Annual rates of lung function decline were : 47 , 38 and 26ml for stages 2-4 and 44 , 48 , 38 and 39 for stages A-D .
-RESULTS	With regards to model fit , the new system performed worse at predicting mortality and lung function decline , and better at predicting exacerbations .
-RESULTS	Distinguishing between the sub-stages of high-risk led to substantial improvements .
-CONCLUSIONS	The new classification system is a modest step towards a phenotype approach .
-CONCLUSIONS	It is probably an improvement for the prediction of exacerbations , but a deterioration for predicting mortality and lung function decline .
-BACKGROUND	ClinicalTrials.gov NCT00144339 ( September 2 , 2005 ) .
-
-###24785854
-OBJECTIVE	To estimate whether continuous combined oral contraceptive pill ( OCP ) use leads to higher continuation and lower pregnancy rates over 12 months than cyclic use in a developing country setting .
-METHODS	We enrolled healthy women aged 18 to 30 years , in Santo Domingo , Dominican Republic .
-METHODS	We randomly assigned women to cyclic or continuous use of OCPs .
-METHODS	Participants made quarterly clinic visits for 12 months .
-METHODS	During follow-up , we reviewed OCP adherence and continuation , side effects , and bleeding , and we tested for pregnancy .
-RESULTS	We enrolled 358 women ( mean age , 22.7 years ) and 335 ( 93.6 % ) completed the study .
-RESULTS	In intent-to-treat analyses , 77.6 % of the continuous use group and 71.7 % of the cyclic group continued OCPs at 12 months ( P = .21 ) .
-RESULTS	The main reason for OCP discontinuation in both groups was running out of OCPs or forgetting .
-RESULTS	Across all visits , 26.1 % of women in the continuous use group and 22.3 % of women in the cyclic group ever reported missing three or more OCPs in the past month ( P = .43 ) .
-RESULTS	In multivariable analyses , regimen was not associated with discontinuation , but both previous birth and perceived ease of use of OCPs decreased risk of discontinuation , whereas desire for reduced menstruation increased risk of discontinuation .
-RESULTS	Although more women reported amenorrhea or infrequent bleeding in the continuous use group , more women in the cyclic group found their bleeding patterns acceptable .
-RESULTS	Bleeding was not associated with discontinuation in multivariable analyses .
-RESULTS	Pregnancy rates at 12 months were similar ( 16.2 % continuous and 17.4 % cyclic ) .
-CONCLUSIONS	Continuous and cyclic OCP regimens were associated with similar 12-month continuation and pregnancy rates .
-CONCLUSIONS	Few factors predicted OCP discontinuation or pregnancy .
-BACKGROUND	ClinicalTrials.gov , www.clinicaltrials.gov , NCT00570440 .
-METHODS	I.
-
-###24991973
-OBJECTIVE	Project Renaissance is a randomized controlled trial of an HIV/hepatitis C virus ( HCV ) / sexually transmitted infection ( STI ) prevention intervention conducted in Almaty , Kazakhstan .
-OBJECTIVE	We hypothesized that couples assigned to the intervention of interest will have lower incidence of HIV , HCV , STIs , rates of unprotected sex , and unsafe injection over the 12-month follow-up period compared with those assigned to an attention control arm .
-METHODS	A total of 300 couples ( 600 participants ) where one or both partners reported injecting drugs in the past 90 days were randomized to 1 of 2 arms : ( 1 ) a 5-session HIV/HCV/STI prevention intervention ( risk reduction : RR ) or ( 2 ) a 5-session Wellness Promotion ( WP ) intervention .
-RESULTS	Over the 12-month follow-up period , assignment to RR compared with WP significantly lowered the incidence of HCV infection by 69 % [ incidence rate ratios ( IRR ) = 0.31 , 95 % ( CI ) confidence interval : 0.10 to 0.90 , P = 0.031 ] .
-RESULTS	Although differences were not statistically significant , RR participants had a lower incidence of HIV infection by 51 % ( IRR = 0.49 , 95 % CI : 0.16 to 1.48 , P = 0.204 ) and any STI by 37 % ( IRR = 0.63 , 95 % CI : 0.21 to 1.93 , P = 0.418 ) than WP participants .
-RESULTS	RR participants reported significantly fewer numbers of unprotected vaginal sex acts with their study partners ( IRR = 0.58 , 95 % CI : 0.36 to 0.93 , P = 0.024 ) and more consistent condom use ( odds ratios = 2.30 , 95 % CI : 1.33 to 4.00 , P = 0.003 ) over the entire follow-up period compared with WP participants .
-CONCLUSIONS	Project Renaissance demonstrated a significant effect for biological and behavioral endpoints .
-CONCLUSIONS	Findings draw attention to an HIV/HCV/STI prevention intervention strategy that can be scaled up for drug-involved couples in harm reduction programs , drug treatment , and criminal justice settings .
-
-###25636293
-OBJECTIVE	To compare the effectiveness of fluoride vanish , fluoride foam , pit and fissure sealant with fluoride in prevention of dental caries , and investigate appropriate approach to prevent dental caries at schools .
-METHODS	A randomized controlled clinical trial with 4 parallel groups was conducted .
-METHODS	Totally 1016 children from 4 schools and 33 classes with a mean age of 7 to 8 years were included .
-METHODS	They were randomly allocated into 4 groups : ( 1 ) fluoride vanish , semi-annual application ; ( 2 ) fluoride foam , semi-annual application ; ( 3 ) resin sealant , single placement ; and ( 4 ) placebo control with oral hygiene instruction .
-METHODS	Follow-up examinations were conducted after 2 years to monitor dental caries increment of first molars among these children .
-METHODS	Data analysis was performed using SPSS 18.0 software package .
-RESULTS	Two years later , 977 children ( 96.2 % ) were examined .
-RESULTS	The results of multiple factor ANCOVA showed that fluoride vanish and resin sealant had significantly lower mean dental caries increment on tooth surface compared with control group ( P < 0.05 ) .
-RESULTS	No significant difference of mean dental caries increment on tooth surface was found between fluoride foam and control group ( P > 0.05 ) .
-CONCLUSIONS	The placement of resin sealant with fluoride and annual application of fluoride protector are effective in prevention of dental caries in permanent teeth of children .
-
-###25942722
-OBJECTIVE	Clostridium difficile is the most common cause of health care-associated infection in US hospitals .
-OBJECTIVE	Recurrence occurs in 25 % to 30 % of patients .
-OBJECTIVE	To determine the safety , fecal colonization , recurrence rate , and optimal dosing schedule of nontoxigenic C. difficile strain M3 ( VP20621 ; NTCD-M3 ) for prevention of recurrent C. difficile infection ( CDI ) .
-METHODS	Phase 2 , randomized , double-blind , placebo-controlled , dose-ranging study conducted from June 2011 to June 2013 among 173 patients aged 18 years or older who were diagnosed as having CDI ( first episode or first recurrence ) and had successfully completed treatment with metronidazole , oral vancomycin , or both at 44 study centers in the United States , Canada , and Europe .
-METHODS	Patients were randomly assigned to receive 1 of 4 treatments : oral liquid formulation of NTCD-M3 , 10 ( 4 ) spores/d for 7 days ( n = 43 ) , 10 ( 7 ) spores/d for 7 days ( n = 44 ) , or 10 ( 7 ) spores/d for 14 days ( n = 42 ) , or placebo for 14 days ( n = 44 ) .
-METHODS	The primary outcome was safety and tolerability of NTCD-M3 within 7 days of treatment .
-METHODS	Exploratory secondary outcomes included fecal colonization with NTCD-M3 from end of study drug through week 6 and CDI recurrence from day 1 through week 6 .
-RESULTS	Among 168 patients who started treatment , 157 completed treatment .
-RESULTS	One or more treatment-emergent adverse events were reported in 78 % of patients receiving NTCD-M3 and 86 % of patients receiving placebo .
-RESULTS	Diarrhea and abdominal pain were reported in 46 % and 17 % of patients receiving NTCD-M3 and 60 % and 33 % of placebo patients , respectively .
-RESULTS	Serious treatment-emergent adverse events were reported in 7 % of patients receiving placebo and 3 % of all patients who received NTCD-M3 .
-RESULTS	Headache was reported in 10 % of patients receiving NTCD-M3 and 2 % of placebo patients .
-RESULTS	Fecal colonization occurred in 69 % of NTCD-M3 patients : 71 % with 10 ( 7 ) spores/d and 63 % with 10 ( 4 ) spores/d .
-RESULTS	Recurrence of CDI occurred in 13 ( 30 % ) of 43 placebo patients and 14 ( 11 % ) of 125 NTCD-M3 patients ( odds ratio [ OR ] , 0.28 ; 95 % CI , 0.11-0 .69 ; P = .006 ) ; the lowest recurrence was in 2 ( 5 % ) of 43 patients receiving 10 ( 7 ) spores/d for 7 days ( OR , 0.1 ; 95 % CI , 0.0-0 .6 ; P = .01 vs placebo ] ) .
-RESULTS	Recurrence occurred in 2 ( 2 % ) of 86 patients who were colonized vs 12 ( 31 % ) of 39 patients who received NTCD-M3 and were not colonized ( OR , 0.01 ; 95 % CI , 0.00-0 .05 ; P < .001 ) .
-CONCLUSIONS	Among patients with CDI who clinically recovered following treatment with metronidazole or vancomycin , oral administration of spores of NTCD-M3 was well tolerated and appeared to be safe .
-CONCLUSIONS	Nontoxigenic C. difficile strain M3 colonized the gastrointestinal tract and significantly reduced CDI recurrence .
-BACKGROUND	clinicaltrials.gov Identifier : NCT01259726 .
-
-###24581245
-BACKGROUND	Untreated behavioral and mental health problems beginning in early childhood are costly problems affecting the long-term health and wellbeing of children , their families , and society .
-BACKGROUND	Although parent training ( PT ) programs have been demonstrated to be a cost-effective intervention modality for treating childhood behavior problems , they have been less effective for children from low-income and underserved racial and ethnic populations .
-BACKGROUND	The purpose of this randomized trial is to compare the effectiveness , cost , and social validity of two manualized evidence-based PT programs that were developed and tested on different populations and employ different delivery models : ( 1 ) The Chicago Parent Program ( CPP ) , a group-based program developed in collaboration with a community advisory board of African-American and Latino parents ; and ( 2 ) Parent-Child Interaction Therapy ( PCIT ) , an individualized parent-child coaching model considered to be ` the gold standard ' for parents of children with externalizing behavior problems .
-METHODS	This trial uses an experimental design with randomization of parents seeking behavioral treatment for their 2 - to 5-year-old children at a mental health clinic in Baltimore , MD ( 80 % African-American or multi-racial ; 97 % receiving Medicaid ) .
-METHODS	Using block randomization procedures , 262 parents are randomized to CPP or PCIT .
-METHODS	Clinicians ( n = 13 ) employed in the mental health clinic and trained in CPP or PCIT are also recruited to participate .
-METHODS	Primary outcomes of interest are reductions in child behavior problems , improvements in parenting , perceived value of the interventions from the perspective of parents and clinicians , and cost .
-METHODS	Parent distress and family social risk are assessed as modifiers of treatment effectiveness .
-METHODS	We hypothesize that CPP will be at least as effective as PCIT for reducing child behavior problems and improving parenting but the programs will differ on cost and their social validity as perceived by parents and clinicians .
-CONCLUSIONS	This is the first study to compare the effectiveness of a PT program originally designed with and for parents from underserved racial and ethnic populations ( CPP ) against a well-established program considered to be the ` the gold standard ' ( PCIT ) with a high-risk population of parents .
-CONCLUSIONS	Challenges related to conducting a randomized trial in a fee-for-service mental health clinic serving urban , low-income families are discussed .
-BACKGROUND	NCT01517867 .
-
-###25458333
-OBJECTIVE	To compare treatment satisfaction between real-time continuous glucose monitoring ( RT-CGM ) and internet-blood glucose monitoring ( IBGM ) in adults with type 2 diabetes treated with insulin .
-METHODS	This study recruited 40 patients who completed a parallel randomized controlled trial comparing a RT-CGM to an IBGM .
-METHODS	Patients in the RT-CGM group monitored their blood-glucose levels bi-weekly and emailed results to their endocrinologist .
-METHODS	Patients in the IBGM group also monitored their blood-glucose levels bi-weekly , but entered their data into an IBGM .
-METHODS	Both groups used a secure website to submit blood-glucose readings and to receive feedback from their endocrinologist .
-METHODS	Feedback included changes in therapy , suggestions on testing frequency , lifestyle modifications and/or encouragement to continue with no changes .
-METHODS	At the end of 6 months , treatment satisfaction was measured using the 8-item Diabetes Treatment Satisfaction Questionnaire .
-METHODS	In this study , `` treatment '' refers to the blood glucose monitoring system to which patients were randomized .
-RESULTS	Thirty-two of the 40 patients completed the treatment satisfaction questionnaire ( 80 % ) .
-RESULTS	Compared to the RT-CGM group , the IBGM group reported a significantly higher level of overall treatment satisfaction ( 24.80 vs. 33.41 , p < 0.000 ) .
-RESULTS	Ratings of individual satisfaction components including convenience , flexibility , likelihood of recommending treatment to others , and willingness to continue with treatment were also found to be significantly higher in the IBGM group .
-CONCLUSIONS	Patients using IBGM are more satisfied with their blood glucose monitoring system compared to those using RT-CGM .
-
-###25233654
-OBJECTIVE	To compare the efficacy differences between fire needling therapy and oxycycline tablets for the treatment of moderate to severe acne vulgaris .
-METHODS	Sixty cases of moderate to severe acne vulgaris were randomly divided into a fire needling group and a medication group , 30 cases in each one .
-METHODS	The pricking method of fire needling at Ashi points around damaged skin was applied in the fire needling group , once every five days for totally 4 times .
-METHODS	The oral administration of oxycycline tablets , 100 mg , was applied in the medication group , twice daily for 20 days , also external application of adapalene gel before sleep was adopted .
-METHODS	The fading time of skin damage , including papule , pustule , nodule and cyst in the two groups was recorded and clinical efficacy was compared .
-METHODS	After the treatment , two-month follow-up was performed to observe the recurrence rate in the two groups .
-RESULTS	The curative rate was 69.0 % ( 20/29 ) in the fire needling group , which was statistically different from 40.0 % ( 12/30 ) in the medication group ( P < 0.05 ) .
-RESULTS	The fading time of each type of skin damage in the fire needling group was shorter than that in the medication group [ papule : ( 2.67 + / - 0.66 ) d vs ( 4.36 + / - 0.61 ) d ; pustule : ( 2.47 + / - 0.57 ) d vs ( 4.27 + / - 0.55 ) d ; nodule : ( 7.76 + / - 1.06 ) d vs ( 9.88-1 .30 ) d ; cyst : ( 11.81 + / - 1.54 ) d vs ( 14.79 + / - 0.89 ) d , all P < 0.05 ] .
-RESULTS	The recurrence rate was 46.4 % ( 13/28 ) in the fire needling group , which was not significantly different from 44.0 % ( 11/24 ) in the medication group ( P > 0.05 ) .
-CONCLUSIONS	The acne vulgaris could be fast and effectively treated by fire needling therapy , which has shorter fading time than oxycycline tablets .
-CONCLUSIONS	However , the preventive effect is not different between the two theraies .
-
-###25212696
-BACKGROUND	Little research has examined whether alcohol reduction interventions improve antiretroviral therapy ( ART ) adherence and HIV treatment outcomes .
-BACKGROUND	This study assesses the efficacy of an intervention for reducing alcohol use among HIV patients on ART who are hazardous/harmful drinkers .
-BACKGROUND	Specific aims include adapting a blended Motivational Interviewing ( MI ) and Problem Solving Therapy ( PST ) intervention for use with HIV patients ; evaluating the efficacy of the intervention for reducing alcohol consumption ; and assessing counsellors ' and participants ' perceptions of the intervention .
-METHODS	A randomised controlled trial will evaluate the intervention among ART patients in public hospital-based HIV clinics in Tshwane , South Africa .
-METHODS	We will recruit patients who are HIV-positive , on ART for at least 3months , and classified as harmful/hazardous drinkers using the AUDIT-3 .
-METHODS	Eligible patients will be randomly assigned to one of three conditions .
-METHODS	Patients in the experimental group will receive the MI-PST intervention to reduce harmful/hazardous alcohol use .
-METHODS	Patients in the equal-attention wellness intervention group will receive an intervention focused on addressing health risk behaviours .
-METHODS	Patients in the control condition will receive treatment as usual .
-METHODS	Participants will complete an interviewer-administered questionnaire at baseline and 3 , 6 and 12months post-randomisation to assess alcohol consumption , ART adherence , physical and mental health .
-METHODS	We will also collect biological specimens to test for recent alcohol consumption , CD4 counts and HIV RNA viral loads .
-METHODS	The primary outcome will be reduction in the volume of alcohol consumed .
-METHODS	Secondary outcomes include reduction in harmful/hazardous use of alcohol , reduction in biological markers of drinking , increase in adherence rates , reductions in viral loads , and increases in CD4 T-cell counts .
-METHODS	A process evaluation will ascertain counsellors ' and participants ' perceptions of the acceptability and effectiveness of the interventions .
-CONCLUSIONS	We have obtained ethical approval and approval from the study sites and regional and provincial health departments .
-CONCLUSIONS	The study has implications for clinicians , researchers and policy makers as it will provide efficacy data on how to reduce harmful/hazardous alcohol consumption among HIV patients and will shed light on whether reducing alcohol consumption impacts on HIV treatment adherence and other outcomes .
-BACKGROUND	Pan African Clinical Trials Register Number : PACTR201405000815100 .
-
-###26325557
-OBJECTIVE	Steroidal mineralocorticoid receptor antagonists , when added to a renin-angiotensin system blocker , further reduce proteinuria in patients with chronic kidney disease but may be underused because of a high risk of adverse events .
-OBJECTIVE	To evaluate the safety and efficacy of different oral doses of the nonsteroidal mineralocorticoid receptor antagonist finerenone , given for 90 days to patients with diabetes and high or very high albuminuria who are receiving an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker .
-METHODS	Randomized , double-blind , placebo-controlled , parallel-group study conducted at 148 sites in 23 countries .
-METHODS	Patients were recruited from June 2013 to February 2014 and the study was completed in August 2014 .
-METHODS	Of 1501 screened patients , 823 were randomized and 821 received study drug .
-METHODS	Participants were randomly assigned to receive oral , once-daily finerenone ( 1.25 mg/d , n = 96 ; 2.5 mg/d , n = 92 ; 5 mg/d , n = 100 ; 7.5 mg/d , n = 97 ; 10 mg/d , n = 98 ; 15 mg/d , n = 125 ; and 25 mg/d , n = 119 ) or matching placebo ( n = 94 ) for 90 days .
-METHODS	The primary outcome was the ratio of the urinary albumin-creatinine ratio ( UACR ) at day 90 vs at baseline .
-METHODS	Safety end points were changes from baseline in serum potassium and estimated glomerular filtration rate .
-RESULTS	The mean age of the participants was 64.2 years ; 78 % were male .
-RESULTS	At baseline , 36.7 % of patients treated had very high albuminuria ( UACR 300 mg/g ) and 40.0 % had an estimated glomerular filtration rate of 60 mL/min/1 .73 m2 or lower .
-RESULTS	Finerenone demonstrated a dose-dependent reduction in UACR .
-RESULTS	The primary outcome , the placebo-corrected mean ratio of the UACR at day 90 relative to baseline , was reduced in the finerenone 7.5 - , 10 - , 15 - , and 20-mg/d groups ( for 7.5 mg/d , 0.79 [ 90 % CI , 0.68-0 .91 ; P = .004 ] ; for 10 mg/d , 0.76 [ 90 % CI , 0.65-0 .88 ; P = .001 ] ; for 15 mg/d , 0.67 [ 90 % CI , 0.58-0 .77 ; P < .001 ] ; for 20 mg/d , 0.62 [ 90 % CI , 0.54-0 .72 ; P < .001 ] ) .
-RESULTS	The prespecified secondary outcome of hyperkalemia leading to discontinuation was not observed in the placebo and finerenone 10-mg/d groups ; incidences in the finerenone 7.5 - , 15 - , and 20-mg/d groups were 2.1 % , 3.2 % , and 1.7 % , respectively .
-RESULTS	There were no differences in the incidence of the prespecified secondary outcome of an estimated glomerular filtration rate decrease of 30 % or more or in incidences of adverse events and serious adverse events between the placebo and finerenone groups .
-CONCLUSIONS	Among patients with diabetic nephropathy , most receiving an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker , the addition of finerenone compared with placebo resulted in improvement in the urinary albumin-creatinine ratio .
-CONCLUSIONS	Further trials are needed to compare finerenone with other active medications .
-BACKGROUND	clinicaltrials.gov Identifier : NCT1874431 .
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-###25437223
-BACKGROUND	Allogeneic red blood cell ( RBC ) transfusion is associated with significant increases in mortality and major morbidity in patients admitted to the intensive care unit , and the blood supplies it requires are an increasingly scarce and costly resource .
-BACKGROUND	Despite high levels of compliance with recommended transfusion thresholds in the ICU , RBC transfusion remains common .
-BACKGROUND	Novel interventions to reduce the incidence of RBC transfusion are required .
-OBJECTIVE	To describe the study protocol for a randomised controlled trial , the Intravenous Iron or Placebo for Anaemia in Intensive Care ( IRONMAN ) trial , comparing intravenous ( IV ) iron with placebo in patients who are admitted to an ICU and are anaemic .
-METHODS	A Phase IIb multicentre , randomised , placebo-controlled trial .
-METHODS	Patients admitted to the ICU with a haemoglobin ( Hb ) level < 100 g/L and predicted to require critical care beyond the next calendar day will be randomly assigned in a 1 : 1 ratio to receive IV ferric carboxymaltose ( 500 mg ) or placebo .
-METHODS	The primary end point will be the mean number of RBC units transfused from study enrolment to discharge from hospital .
-METHODS	Secondary end points will include change in Hb level and incidence of nosocomial infection .
-CONCLUSIONS	The IRONMAN trial is designed to determine whether IV iron administered to patients admitted to an ICU and who are anaemic is associated with a reduction in RBC transfusion , compared with placebo in addition to standard care .
-CONCLUSIONS	The results of this trial may determine whether a Phase III trial of IV iron in ICUs is feasible .
-BACKGROUND	Australian New Zealand Clinical Trials Registry ( ACTRN12612001249842 ) .
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-###25427324
-OBJECTIVE	To assess and compare the efficacy of single buccal and palatal infiltration of lidocaine , mepivacaine , or articaine with 1:100000 epinephrine by maxillary anesthetic injection .
-METHODS	A double-blinded , randomized , clinical trial was conducted with 33 patients undergoing upper premolar extraction .
-METHODS	The patients were randomly allocated into one of three groups , according to the local anesthetic agent used : 2 % lidocaine , 2 % mepivacaine , or 4 % articaine , all with 1:100000 epinephrine , and were blinded to the anesthetic used .
-METHODS	The extent of anesthetization , pulpal anesthetization in adjacent teeth , pain on injection , and adverse effects of the anesthetic agents were assessed .
-RESULTS	The extent of anesthetization produced by 4 % articaine ( 42mm ) was statistically more significant ( P0 .05 ) than 2 % lidocaine ( 33mm ) and 2 % mepivacaine ( 32.5 mm ) .
-RESULTS	The successful anesthetization of adjacent teeth occurred more often in the articaine group than in the lidocaine and mepivacine groups , although not to a statistically-significant extent .
-RESULTS	The pain scores for the injections were comparable between the three groups .
-CONCLUSIONS	Local anesthetization using 4 % articaine with 1:100000 epinephrine covers a wider area of soft tissue and adjacent teeth than 2 % lidocaine or 2 % mepivacaine with 1:100000 epinephrine , which is sufficient for the extraction of one or two teeth .
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-###25417309
-OBJECTIVE	To investigate the role of 1,25-dihydroxyvitamin D3 in the posterior transforaminal lumbar interbody fusion ( TLIF ) for patients with osteoporosis and lumbar degenerative disease .
-METHODS	Between November 20ll and October 2012 , 44 patients with osteoporosis and lumbar degenerative disease were treated with TLIF and the clinical data were retrospectively analyzed .
-METHODS	The patients were divided into 2 groups based on the administration of 1,25-dihydroxyvitamin D3 .
-METHODS	After TLIF operation , 1,25-dihydroxyvitamin D3 was used in 21 patients ( trial group ) , and was not used in 23 patients ( control group ) .
-METHODS	There was no significant difference in gender , age , etiology , affected segment , and disease duration between 2 groups ( P > 0.05 ) .
-METHODS	Lumbar interbody fusion was observed by X-ray and thin-section CT scan reconstruction of lumbar spine according to Brantigan assessment system at 6 months after operation and last follow-up .
-METHODS	Clinical outcome was evaluated by Oswestry disability index ( ODI ) before and after operation .
-RESULTS	The patients of 2 groups were followed up 12-27 months ( mean , 14.5 months ) .
-RESULTS	No fixation loosening or breaking occurred during follow-up .
-RESULTS	ODI scores in both groups were significantly improved at 6 months after operation and last follow-up ( P < 0.05 ) when compared with preoperative value .
-RESULTS	Although at preoperation there was no significant difference in ODI score between 2 groups ( P > 0.05 ) , ODI score of trial group was significantly lower than that of control group at 6 months after operation and last follow-up ( P < 0.05 ) .
-RESULTS	At 6 months after operation , the interbody fusion rate was 76.19 % ( 16/21 ) in trial group and 43.48 % ( 10/23 ) in control group , showing significant difference ( 2 = 3.60 , P = 0.03 ) ; at last follow-up , the fusion rate was 95.24 % ( 20/21 ) in trial group and 65.22 % ( 15/23 ) in control group , showing significant difference ( 2 = 4.38 , P = 0.02 ) .
-CONCLUSIONS	1,25-dihydroxyvitamin D3 can improve the lumbar interbody fusion rate and general conditions in the patients with osteoporosis and lumbar degenerative disease .
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-###25195125
-BACKGROUND	The incidence of perioperative myocardial infarction ( PMI ) globally is known to be around 2 to 3 % and can prolong hospitalization , increased morbidity and mortality .
-BACKGROUND	Little is known about the pathophysiology and risk factors for PMI .
-BACKGROUND	We investigate the presence of elevated novel cardiac markers and preoperative coronary artery plaque through contemporary laboratory techniques to determine the correlation with PMI , as well as studying ivabradine and atorvastatin as protective pharmacotherapies against PMI in the context of orthopedic surgery .
-METHODS	We aim to enroll 200 patients aged above 60 years who suffer from neck of femur fracture requiring surgery .
-METHODS	Patients will be randomized to four arms ( no study drugs , atorvastatin only , ivabradine only and ivabradine and atorvastatin ) .
-METHODS	Our primary outcome is incidence of PMI .
-METHODS	All patients will receive an electrocardiogram , cardiac echocardiography , measurement of novel cardiac biomarkers and computed tomography ( CT ) coronary angiography .
-METHODS	A telephone interview post discharge will be conducted at 30 days , 60 days and 1 year .
-CONCLUSIONS	We postulate that ivabradine and atorvastatin will reduce the rate and magnitude of PMI following surgery by reducing heart rate and attenuating catecholamine-induced tachycardia postoperatively .
-CONCLUSIONS	Secondly , we postulate that postoperative reduction in heart rate and catecholamine-induced tachycardia with ivabradine will correlate with a reduction in cardiovascular novel biomarkers which will reduce atrial stretch and postoperative incidence of arrhythmia .
-CONCLUSIONS	We aim to demonstrate that treatment with ivabradine and atorvastatin will cause a reduction in the incidence and magnitude of PMI , the benefit of which is derived primarily in patients with greater atherosclerotic burden as measured by higher CT coronary calcium scores .
-BACKGROUND	This study protocol has been listed in the Australia New Zealand Clinical Trial Registry ( registration number : ACTRN12612000340831 ) on 23 March 2012 .
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-###25342855
-OBJECTIVE	The aim of the present study was to evaluate the natural course of acute incomplete stent apposition ( ISA ) after second-generation everolimus-eluting stent ( EES ) when compared with first-generation sirolimus-eluting stent ( SES ) by using optical coherence tomography ( OCT ) .
-RESULTS	From the OCT substudy of the RESET trial , we identified 77 patients ( EES = 38 and SES = 39 ) who successfully underwent serial OCT examination at post-stenting and 8-12-month follow-up .
-RESULTS	The presence of ISA was assessed in the OCT images , and ISA distance was measured from the centre of the strut blooming to the adjacent lumen border .
-RESULTS	Incomplete stent apposition was observed in all EES and SES at post-stenting , and it was persistent in 26 % of EES and 38 % of SES at 8-12-month follow-up .
-RESULTS	Maximum ISA distance was significantly decreased during the follow-up period in both EES ( 315 94-110 165 m , P < 0.001 ) and SES ( 308 119-143 195 m , P < 0.001 ) .
-RESULTS	Receiver-operating curve analysis identified that the best cut-off value of OCT-estimated ISA distance at post-stenting for predicting late-persistent ISA at 8-12-month follow-up in EES and SES was > 355 and > 285 m , respectively .
-CONCLUSIONS	The second-generation EES showed better healing of acute ISA in comparison with the first-generation SES .
-CONCLUSIONS	Optical coherence tomography can predict late-persistent ISA after DES implantation and provide useful information to optimize PCI .
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-###25504267
-OBJECTIVE	Small single-center comparative studies suggest improved outcomes in cardiac resynchronization therapy ( CRT ) patients implanted with a quadripolar left ventricular ( LV ) lead in comparison with non-quadripolar ( bipolar ) leads .
-OBJECTIVE	This study represents the first large multicenter prospective registry comparing implant and 6-month postoperative lead performance following CRT-defibrillator ( CRT-D ) implantation with quadripolar vs. bipolar leads .
-METHODS	During a 39-month period , 418 consecutive patients having CRT-D implantation attempts with either a quadripolar ( n = 230 ) or bipolar LV lead ( n = 188 ) were enrolled in the registry .
-METHODS	The primary outcome of the study was LV lead failure defined as any abnormality , excluding infection , resulting in surgical lead revision or CRT termination .
-METHODS	Additionally , operative and follow-up data were analyzed for significant difference between groups .
-RESULTS	Baseline characteristics of both groups were similar .
-RESULTS	In 72.9 % of quadripolar leads versus 65.0 % of bipolar leads , the LV lead successfully engaged the predefined ideal target side branch ( p = 0.47 ) .
-RESULTS	Implant duration and fluoroscopy times were significantly shorter when a quadripolar lead was used ( p = 0.007 and p = 0.001 , respectively ) .
-RESULTS	The primary end point occurred in six patients ( 2.7 % ) in the quadripolar group and in 14 patients ( 8.0 % ) in the bipolar group ( p = 0.02 ) .
-RESULTS	Clinically significant phrenic nerve stimulation ( PNS ) occurred in 4.6 vs. 14.2 % of quadripolar vs. bipolar patients , respectively ( p = 0.002 ) ; all PNS were resolved noninvasively through programming in the quadripolar group vs. 84 % in bipolar group ( p = 0.75 ) .
-RESULTS	The use of a bipolar lead was associated with a higher risk of surgical LV lead revision ( 6.3 vs. 2.3 % ; p = 0.057 ) and a higher incidence of dislodgment ( 5.7 vs. 2.7 % ; p = 0.16 ) .
-CONCLUSIONS	This multicenter study demonstrates that the use of a quadripolar LV lead results in significantly lower rates of lead-related problems and reduced procedural and fluoroscopic times for biventricular system implantation .
-CONCLUSIONS	This has important implications for LV pacing lead choice .
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-###25028463
-BACKGROUND	Rapid sputum culture conversion at 2 months indicates the sterilizing capacity and potential of regimens to shorten duration of tuberculosis treatment .
-BACKGROUND	We compared results of sputum culture conversion by moxifloxacin and control regimens and identified factors affecting sputum culture positivity after 2 months of treatment .
-METHODS	Human immunodeficiency virus-uninfected adults with newly diagnosed smear-positive pulmonary tuberculosis were randomized to receive a 3 - or 4-month moxifloxacin regimen ( moxifloxacin [ M ] , isoniazid [ H ] , rifampicin [ R ] , pyrazinamide [ Z ] , ethambutol [ E ] ) or the control regimen ( RHZE thrice weekly ) .
-METHODS	Bacteriological assessments were done at 15 , 30 , 45 , and 60 days of treatment .
-METHODS	Because all patients in the moxifloxacin groups received 2 months of daily RHZEM , they were grouped together for analysis .
-METHODS	Statistical methods included ( 2 ) test and logistic regression analysis .
-RESULTS	Sputum culture conversion was analyzed in 780 ( 616 in the moxifloxacin group and 164 in the control group ) of 801 enrolled patients .
-RESULTS	Ninety-five percent of 590 patients in the moxifloxacin group and 81 % of 151 patients in the control group had negative sputum cultures at month 2 ( P < .001 ) .
-RESULTS	The control regimen , age ( 35 years ) , initial sputum culture grade ( 2 + or 3 + ) , and male sex were significantly associated with higher odds of positive sputum cultures at 2 months .
-CONCLUSIONS	A 5-drug daily regimen with moxifloxacin results in significantly higher sputum culture conversion in the first 2 months compared with a thrice-weekly , 4-drug regimen in patients with newly diagnosed sputum-positive pulmonary tuberculosis .
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-###24261927
-METHODS	Randomized clinical trial .
-OBJECTIVE	To compare the effectiveness of the Alfredson eccentric heel-drop protocol with a `` do-as-tolerated '' protocol for nonathletic individuals with midportion Achilles tendinopathy .
-BACKGROUND	The Alfredson protocol recommends the completion of 180 eccentric heel drops a day .
-BACKGROUND	However , completing this large number of repetitions is time consuming and potentially uncomfortable .
-BACKGROUND	There is a need to investigate varying exercise dosages that minimize the discomfort yet retain the clinical benefits .
-METHODS	Twenty-eight individuals from outpatient physiotherapy departments were randomized to either the standard ( n = 15 ) or the do-as-tolerated ( n = 13 ) 6-week intervention protocol .
-METHODS	Apart from repetition volume , all other aspects of management were standardized between groups .
-METHODS	Tendinopathy clinical severity was assessed with the Victorian Institute of Sport Assessment-Achilles ( VISA-A ) questionnaire .
-METHODS	Pain intensity was assessed using a visual analog scale ( VAS ) .
-METHODS	Both were assessed at baseline , 3 weeks , and 6 weeks .
-METHODS	Treatment satisfaction was assessed at week 6 .
-METHODS	Adverse effects were also monitored .
-RESULTS	There was a statistically significant within-group improvement in VISA-A score for both groups ( standard , P = .03 ; do as tolerated , P < .001 ) and VAS pain for the do-as-tolerated group ( P = .001 ) at week 6 , based on the intention-to-treat analysis .
-RESULTS	There was a statistically significant between-group difference in VISA-A scores at week 3 , based on both the intention-to-treat ( P = .004 ) and per-protocol analyses ( P = .007 ) , partly due to a within-group deterioration at week 3 in the standard group .
-RESULTS	There were no statistically significant between-group differences for VISA-A and VAS pain scores at week 6 , the completion of the intervention .
-RESULTS	There was no significant association between satisfaction and treatment groups at week 6 .
-RESULTS	No adverse effects were reported .
-CONCLUSIONS	Performing a 6-week do-as-tolerated program of eccentric heel-drop exercises , compared to the recommended 180 repetitions per day , did not lead to lesser improvement for individuals with midportion Achilles tendinopathy , based on VISA-A and VAS scores .
-