After a two-week placebo run-in period GSK@ was up-titrated over @ weeks in a flexible manner ( @-@-@-@ microgram -LSB- g -RSB- ) followed by a @-week Maintenance Phase .


Co-primary efficacy endpoints were change from baseline in Episodic Memory and Executive Function/Working Memory composite scores from the CogState neuropsychological test battery ( NTB ) at Week @ .


Compared to placebo , GSK@ improved Episodic Memory at Week @ ( Effect Size -LSB- ES -RSB- = @ ; p = @ ) .


No statistically significant differences were observed on other cognitive domains or on clinical measures including the Alzheimer 's Disease Assessment Scale-Cognitive Subscale ( ADASCog ) .


GSK@ treatment was associated with mild to moderate adverse events with headache , dizziness and events related to sleep disturbances being the most common and more pronounced in the early titration period when subjects were first being exposed to GSK@ at the lower @g and @g doses .


There were no clinically relevant changes in other safety parameters .


GSK@ , at doses up to @g/day , improved Episodic Memory in patients with mildto - moderate AD .


However , no improvements were observed on Executive Function/Working Memory or other domains of cognition .


No changes were observed on any of the clinical measures included as secondary endpoints ( including ADAS-Cog ) indicating that GSK@ failed to show benefit in this population .


GSK@ had an acceptable safety and tolerability profile .


These findings suggest that H@ antagonists may , at most , have modest and selective effects on cognitive function in patients with mild-to-moderate AD .


Infant formulae are being supplemented with probiotics , prebiotics , or symbiotic despite uncertainties regarding their efficacy .


Mexican agave is an interesting source of fructans with particular features and with potential prebiotic effects .


RCT in @ healthy term babies ( @ @ days ) , allocated to receive standard infant formula ( control ) or infant formula added with a dual prebiotic system `` Metlin and Metlos '' , from Mexican agave .


Primary outcomes include stools frequency , stools consistency , gastrointestinal intolerance ( frequency of abdominal distension , flatulency , regurgitations , vomiting ) .


Secondary outcomes include changes on weight and height along the study and frequency of dermatologic problems ( eczema ) .


In @,@ days of total follow-up , there were no differences on the frequency of stools passage ( Human Milk : @ @ evacuations per day ; Pro + Metlin + Metlos @ @ ; Pro + Metlin @ @ ; only Pro @ @ only formula @ @ ; p NS ) .


Consistency of stools was similar between human milk and prebiotics supplemented groups .


Also the frequency of gastrointestinal symptoms was significantly low between these groups .


Fructans derivate from agave and added to infant formula are safe and well tolerated by Mexican healthy term babies .


This study evaluated the effect of resveratrol administration on metabolic syndrome , insulin sensitivity , and insulin secretion .


A randomized , double-blind , placebo-controlled clinical trial was carried out in @ patients with diagnosis of metabolic syndrome in accordance with the International Diabetes Federation criteria .


Glucose and insulin levels were measured after a @-gram dextrose load .


Triglycerides and high-density lipoprotein cholesterol concentrations at baseline were also evaluated .


Twelve patients received trans-resveratrol ( @mg ) three times per day before meals for @ days .


The remaining @ patients received placebo at the same dose .


The area under the curve ( AUC ) values of glucose and insulin , total insulin secretion , first-phase of insulin secretion , and insulin sensitivity were calculated .


After resveratrol administration , there were significant differences in total weight ( @ vs. @ kg , P = @ ) , body mass index ( BMI ) ( @ vs. @ kg/m ( @ ) , P = @ ) , fat mass ( @ vs. @ kg , P = @ ) , and waist circumference ( WC ) ( @ vs. @cm , P = @ ) .


There were also significant differences in AUC of insulin ( @,@,@ vs. @,@,@ pmol/L , P = @ ) and insulinogenic index ( @ vs. @ , P = @ ) .


Administration of resveratrol significantly decreases weight , BMI , fat mass , WC , AUC of insulin , and total insulin secretion .


Most patients with non-small-cell lung cancer tumours that have EGFR mutations have deletion mutations in exon @ or the Leu@Arg point mutation in exon @ , or both ( ie , common mutations ) .


However , a subset of patients ( @ % ) with mutations in EGFR have tumours that harbour uncommon mutations .


There is a paucity of data regarding the sensitivity of these tumours to EGFR inhibitors .


Here we present data for the activity of afatinib in patients with advanced non-small-cell lung cancer that have tumours harbouring uncommon EGFR mutations .


In this post-hoc analysis , we used prospectively collected data from tyrosine kinase inhibitor-naive patients with EGFR mutation-positive advanced ( stage IIIb-IV ) lung adenocarcinomas who were given afatinib in a single group phase @ trial ( LUX-Lung @ ) , and randomised phase @ trials ( LUX-Lung @ and LUX-Lung @ ) .


Analyses were done in the intention-to-treat population , including all randomly assigned patients with uncommon EGFR mutations .


The type of EGFR mutation ( exon @ deletion -LSB- del@ -RSB- , Leu@Arg point mutation in exon @ , or other ) and ethnic origin ( LUX-Lung @ only ; Asian vs non-Asian ) were pre-specified stratification factors in the randomised trials .


We categorised all uncommon mutations as : point mutations or duplications in exons @-@ ( group @ ) ; de-novo Thr@Met mutations in exon @ alone or in combination with other mutations ( group @ ) ; or exon @ insertions ( group @ ) .


We also assessed outcomes in patients with the most frequent uncommon mutations , Gly@Xaa , Leu@Gln , and Ser@Ile , alone or in combination with other mutations .


Response was established by independent radiological review .


These trials are registered with ClinicalTrials.gov , numbers NCT@ , NCT@ , and NCT@ .


Of @ patients given afatinib across the three trials , @ ( @ % ) patients had uncommon EGFR mutations ( @ in group @ , @ in group @ , @ in group @ ) .


@ ( @ % , @ % CI @-@ ) patients in group @ had objective responses , as did two ( @ % , @-@ ) in group @ and two ( @ % , @-@ ) in group @ .


Median progression-free survival was @ months ( @ % CI @-@ ) in group @ , @ months ( @-@ ) in group @ ; and @ months ( @-@ ) in group @ .


Median overall survival was @ months ( @ % CI @-@ ) in group @ , @ months ( @-@ ) in group @ , and @ months ( @-@ ) in group @ .


For the most frequent uncommon mutations , @ ( @ % , @ % CI @-@ ) patients with Gly@Xaa had an objective response , as did nine ( @ % , @-@ ) with Leu@Gln , and eight ( @ % , @-@ ) with Ser@Ile .


Afatinib was active in non-small-cell lung cancer tumours that harboured certain types of uncommon EGFR mutations , especially Gly@Xaa , Leu@Gln , and Ser@Ile , but less active in other mutations types .


Clinical benefit was lower in patients with de-novo Thr@Met and exon @ insertion mutations .


These data could help inform clinical decisions for patients with non-small-cell lung cancer harbouring uncommon EGFR mutations .


Recent studies found omega-@ fatty acid deficiency in brain cell membranes of schizophrenic patients .


Conventional antipsychotics have many adverse reactions .


Safety , availability and low price made omega-@ as a potential supplement for treatment of these patients .


This study investigated the efficacy of omega-@ fatty acid as add-on treatment in schizophrenia .


A randomized , double blind , placebo controlled fixed-dose , add-on clinical trial conducted over @ weeks .


@ patients with documented schizophrenia randomly divided into two groups : omega-@ ( @ mg/day ) ( n = @ ) and placebo ( n = @ ) .


Patients received omega-@ or placebo in addition to their standard antipsychotic treatment .


Patient follow up was done using Positive and Negative syndrome Scale ( PANSS ) .


Data analyzed using SPSS software v. @ .


At the end of @ weeks treatment , PANSS score decreased significantly in both groups ( p < @ ) in comparison to baseline .


Efficacy of omega-@ in decreasing general psychopathologic and total scores was significant in comparison to placebo group from @ and @ weeks after onset of treatment , respectively ( p < @ ) .


Totally , omega-@ supplement therapy efficacy in comparison to sole conventional antipsychotics was @ which was not significant ( p > @ ) .


we found that supplemental omega-@ might increase efficacy of conventional antipsychotics in decreasing symptoms of schizophrenia .


Low price , rare adverse reactions and availability of omega-@ made this substance a potential supplement in improved treatment of schizophrenia


To evaluate the effects of caffeinated energy shots compared with noncaffeinated energy shots as assessed by changes in peripheral and central hemodynamic parameters in healthy subjects .


Randomized , double-blind , controlled crossover study .


University campus .


Ten healthy volunteers .


Subjects were randomized to receive either a caffeinated or noncaffeinated energy shot ; after a minimum @ days washout period , subjects were given the alternate energy shot .


Peripheral blood pressures , and central hemodynamic parameters , were assessed and recorded for each subject at baseline and at @ and @ hours after consumption of the energy shots .


Peripheral systolic blood pressure ( SBP ) increased significantly with the caffeinated energy shot compared with noncaffeinated ( @ @ mm Hg and -@ @ , respectively , p = @ ) at @ hours .


Central SBP increased significantly with the caffeinated energy shot compared with noncaffeinated ( @ @ mm Hg and @ @ , respectively , p = @ ) at @ hours .


Peripheral and central diastolic blood pressure were nonsignificantly higher with the caffeinated energy shot at @ hours .


Peripheral and central pulse pressure were consistently higher with consumption of the caffeinated beverage .


Heart rate , augmentation index , pulse pressure amplification ratio , ejection duration and Subendocardial Viability Ratio were not different between the two interventions over time .


P@ height was significantly higher with the caffeinated shot compared with the noncaffeinated shot at both @ and @ hours ( p = @ and @ , respectively ) .


Three and one subjects experienced an adverse effect with the caffeinated and noncaffeinated shot , respectively .


A caffeinated energy shot acutely increases peripheral and central SBPs compared with a noncaffeinated energy shot .


Larger studies with a placebo comparator are needed to assess the significance of peripheral and central hemodynamic changes with noncaffeinated energy drinks .


Xanthelasma palpebrarum ( XP ) is a common cosmetic concern .


Although there is a wide range of therapeutic modalities for XP , there is no general consensus on the optimal treatment for such condition .


Compare the efficacy and safety of super pulsed ( SP ) and fractional CO@ lasers in the treatment of XP .


This prospective randomized comparative clinical study included @ adult patients with bilateral and symmetrical XP lesions .


Xanthelasma palpebrarum lesions were randomly assigned to treatment by either single session of ablative SP CO@ laser or @ to @ sessions of ablative fractional CO@ laser with monthly intervals .


All patients were assessed using digital photography and optical coherence tomography images .


Xanthelasma palpebrarum lesions on both sides were successfully removed with significant improvement in size , color , and thickness .


Although lesions treated by SP CO@ laser showed significantly better improvement regarding color and thickness of the lesions , downtime and patient satisfaction were significantly better for lesions treated with fractional CO@ laser .


Scarring and recurrence were significantly higher in lesions treated by SP CO@ laser .


Ablative fractional CO@ laser is an effective and safe therapeutic option for XP with significantly shorter downtime and higher patient satisfaction compared with SP CO@ laser .


Orally anticoagulated patients with insufficient knowledge about their treatment have a higher risk of complications .


Standardized patient education could raise their level of knowledge and improve time spent within target INR range .


This cluster randomized trial included @ anticoagulated patients drawn from @ general medical practices .


@ patients received patient education , conducted by practice nurses , consisting of a video , a brochure , and a questionnaire ; @ control patients received only the brochure .


The primary endpoint was knowledge about treatment six months after the patient education session .


The secondary endpoints were time in the INR ( international normalized ratio ) target range and complications of anticoagulation .


Patients in the intervention and control groups were of comparable mean age ( @ vs. @ years ) .


They answered a comparable number of questions correctly before the intervention ( @ @ vs. @ @ ) but differed significantly on this measure at six months ( @ @ vs. @ @ , mean difference @ questions , @ % confidence interval -LSB- CI -RSB- @-@ @ , p < @ ) .


In the six months prior to the intervention , the INR was in the target range @ @ % vs. @ @ % of the time ; in the six months afterward , @ @ % vs. @ @ % of the time ( mean difference @ percentage points , @ % CI -@ to -@ percentage points , p = @ ) .


The complication rates were comparable in the two groups ( @ % vs. @ % , p = @ ) .


Patients in the intervention group approved of patient education sessions to a greater extent than control patients ( @ % vs. @ % ) .


Patient education was found to be practical , to improve knowledge relating to patient safety in a durable manner , and to meet with the approval of the patients who received it .


There was a statistically non-significant trend toward an improvement of the time spent in the INR target range .


In view of the major knowledge deficits of orally anticoagulated patients , standardized patient education ought to be made a part of their routine care .


Reproductive-age women need effective interventions to prevent the acquisition of human immunodeficiency virus type @ ( HIV-@ ) infection .


We conducted a randomized , placebo-controlled trial to assess daily treatment with oral tenofovir disoproxil fumarate ( TDF ) , oral tenofovir-emtricitabine ( TDF-FTC ) , or @ % tenofovir ( TFV ) vaginal gel as preexposure prophylaxis against HIV-@ infection in women in South Africa , Uganda , and Zimbabwe .


HIV-@ testing was performed monthly , and plasma TFV levels were assessed quarterly .


Of @,@ women who were screened , @ were enrolled in the study .


The rate of retention in the study was @ % during @ person-years of follow-up .


A total of @ HIV-@ infections occurred ; the incidence of HIV-@ infection was @ per @ person-years .


In the modified intention-to-treat analysis , the effectiveness was -@ % with TDF ( hazard ratio for infection , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ) , -@ % with TDF-FTC ( hazard ratio , @ ; @ % CI , @ to @ ) , and @ % with TFV gel ( hazard ratio , @ ; @ % CI , @ to @ ) .


In a random sample , TFV was detected in @ % , @ % , and @ % of available plasma samples from participants randomly assigned to receive TDF , TDF-FTC , and TFV gel , respectively .


Independent predictors of TFV detection included being married , being older than @ years of age , and being multiparous .


Detection of TFV in plasma was negatively associated with characteristics predictive of HIV-@ acquisition .


Elevations of serum creatinine levels were seen more frequently among participants randomly assigned to receive oral TDF-FTC than among those assigned to receive oral placebo ( @ % vs. @ % , P = @ ) .


We observed no significant differences in the frequencies of other adverse events .


None of the drug regimens we evaluated reduced the rates of HIV-@ acquisition in an intention-to-treat analysis .


Adherence to study drugs was low .


( Funded by the National Institutes of Health ; VOICE ClinicalTrials.gov number , NCT@ . )


Rifampicin and protease inhibitors are difficult to use concomitantly in patients with HIV-associated tuberculosis because of drug-drug interactions .


Rifabutin has been proposed as an alternative rifamycin , but there is concern that the current recommended dose is suboptimal .


The principal aim of this study was to compare bioavailability of two doses of rifabutin ( @ mg three times per week and @ mg daily ) in patients with HIV-associated tuberculosis who initiated lopinavir/ritonavir-based antiretroviral therapy in Vietnam .


Concentrations of lopinavir/ritonavir were also measured .


This was a randomized , open-label , multi-dose , two-arm , cross-over trial , conducted in Vietnamese adults with HIV-associated tuberculosis in Ho Chi Minh City ( Clinical trial registry number NCT@ ) .


Rifabutin pharmacokinetics were evaluated before and after the introduction of lopinavir/ritonavir - based antiretroviral therapy using patient randomization lists .


Serial rifabutin and @-O-desacetyl rifabutin concentrations were measured during a dose interval after @ weeks of rifabutin @ mg daily , after @ weeks of rifabutin @ mg daily with lopinavir/ritonavir and after @ weeks of rifabutin @ mg three times per week with lopinavir/ritonavir .


Sixteen and seventeen patients were respectively randomized to the two arms , and pharmacokinetic analysis carried out in @ and @ respectively .


Rifabutin @ mg daily with lopinavir/ritonavir was associated with a @ % mean increase in rifabutin average steady state concentration compared with rifabutin @ mg alone .


In contrast , the rifabutin average steady state concentration decreased by @ % when rifabutin was given at @ mg three times per week with lopinavir/ritonavir .


With both dosing regimens , @ - @ fold increases of the @-O-desacetyl - rifabutin metabolite were observed when rifabutin was given with lopinavir/ritonavir compared with rifabutin alone .


The different doses of rifabutin had no significant effect on lopinavir/ritonavir plasma concentrations .


Based on these findings , rifabutin @ mg daily may be preferred when co-administered with lopinavir/ritonavir in patients with HIV-associated tuberculosis .


Weight loss after pharmacotherapy varies greatly .


We aimed to examine associations of quantitative gastrointestinal and psychological traits with obesity , and to validate the ability of these traits to predict responses of obese individuals to pharmacotherapy .


In a prospective study , we measured gastric emptying of solids and liquids , fasting and postprandial gastric volume , satiation by nutrient drink test ( volume to fullness and maximal tolerated volume ) , satiety after an ad libitum buffet meal , gastrointestinal hormones , and psychological traits in @ normal-weight , overweight , or obese adults .


We also analyzed data from @ previously studied adults to assess associations betwecen a subset of traits with body mass index and waist circumference .


Latent dimensions associated with overweight or obesity were appraised by principal component analyses .


We performed a proof of concept , placebo-controlled trial of extended-release phentermine and topiramate in @ patients to validate associations between quantitative traits and response to weight-loss therapy .


In the prospective study , obesity was associated with fasting gastric volume ( P = @ ) , accelerated gastric emptying ( P < @ for solids and P = @ for liquids ) , lower postprandial levels of peptide tyrosine tyrosine ( P = @ ) , and higher postprandial levels of glucagon-like peptide @ ( P < @ ) .


In a combined analysis of data from all studies , obesity was associated with higher volume to fullness ( n = @ ; P = @ ) and satiety with abnormal waist circumference ( n = @ ; P = @ ) .


Principal component analysis identified latent dimensions that accounted for approximately @ % of the variation among overweight and obese subjects , including satiety or satiation ( @ % ) , gastric motility ( @ % ) , psychological factors ( @ % ) , and gastric sensorimotor factors ( @ % ) .


The combination of phentermine and topiramate caused significant weight loss , slowed gastric emptying , and decreased calorie intake ; weight loss in response to phentermine and topiramate was significantly associated with calorie intake at the prior satiety test .


Quantitative traits are associated with high body mass index ; they can distinguish obesity phenotypes and , in a proof of concept clinical trial , predicted response to pharmacotherapy for obesity .


ClinicalTrials.gov Number : NCT@ .


Computer-based educational games present an opportunity for health education in school ; however , their feasibility in school settings and effectiveness in changing behavior are poorly understood .


To evaluate the feasibility , acceptability , and effects of the Quest to Lava Mountain ( QTLM ) computer game on dietary behaviors , physical activity behaviors , and psychosocial factors among ethnically diverse children in Texas .


Quasi-experimental group-randomized controlled trial conducted during the @-@ school year .


A total of @ children in fourth and fifth grade consented .


There was an attrition rate of @ % with a final sample size of @ children in three intervention schools , and a sample of @ children in three comparison schools .


Dietary intake was measured using two random @-hour recalls , whereas child self-report surveys measured diet , physical activity , and psychosocial factors before and after the intervention .


Process data on QTLM usability and back-end server data on QTLM exposure and progress achieved were collected .


QTLM was implemented as part of the in-school or afterschool program .


Recommended game exposure duration was @ min/wk for @ weeks .


Analysis of covariance or logistic regression models evaluated effects of QTLM on diet , physical activity , and psychosocial factors .


Post hoc exploratory analysis examined the changes before and after the intervention in outcome variables among children in the intervention group .


Significance was set at P < @ .


Children played an average of @ minutes ( approximately @ hours ) of QTLM during the @ weeks ( @ % of recommended dosage ) .


Compared with the comparison group , children in the intervention group reported decreased sugar consumption ( P = @ ) and higher nutrition/physical activity attitudes ( P = @ ) pre - to postintervention .


There were no significant effects of QTLM on physical activity .


However , post hoc analysis showed that higher QTLM exposure and gaming progress was associated with increased frequency of physical activity ( P < @ ) .


QTLM has some promising acceptability and initial effects on diet and physical activity behaviors among children in elementary school .


House dust mite ( HDM ) allergy is associated with persistent allergic rhinitis ( AR ) and allergic asthma .


To investigate the efficacy and safety of a SQ HDM sublingually administered immunotherapy tablet ( ALK , Hrsholm , Denmark ) in adults and adolescents with HDM respiratory allergic disease and report the AR results .


Six hundred four subjects at least @ years old with HDM AR and mild to moderate HDM allergic asthma were randomized @:@:@:@ to double-blinded daily treatment with @ , @ , @ SQ-HDM or placebo .


End-of-treatment rhinoconjunctivitis symptoms and medication score were predefined extrapulmonary end points .


A subgroup analysis was conducted post hoc in subjects with a total combined rhinitis score ( TCRS ) > @ ( ie , with AR symptoms and/or AR medication use during the @-week baseline period ) .


The subgroup was comprised of @ subjects ( @ % ) .


In the subgroup , the absolute difference in end-of-treatment TCRS between @ SQ-HDM and placebo was-@ @ ( @ % confidence interval-@ @ to-@ @ , relative difference @ % , P = @ ) .


Furthermore , a significant difference was found for the total score of the Rhinitis Quality of Life Questionnaire with Standardized Activities RQLQ ( S ) and for the individual domains : activities , sleep , non-nose and non-eye symptoms , and nasal symptoms .


For the TCRS and Rhinitis Quality of Life Questionnaire score , a dose response was seen , with numerically lower , nonsignificant differences for @ and @ SQ-HDM .


The predefined analysis for the entire trial population showed no statistically significant difference between the placebo and actively treated groups .


No safety concerns were observed .


Efficacy in mild to severe AR of @ SQ-HDM compared with placebo was demonstrated by statistically significant improvements in TCRS and Rhinitis Quality of Life Questionnaire score in subjects with AR present at baseline .


The treatment was well tolerated .


This study aimed to investigate the neuromuscular adaptation following a @-week high frequency and low amplitude whole body vibration ( WBV ) exercise training .


The study is a prospective , double blind , randomized controlled intervention design with a total of @ subjects volunteered to participate in the study .


They were randomly assigned either to WBV exercise training or control group .


Both groups participated in a @-week training program .


The intervention group received WBV in semi-squat position on a device with an amplitude of @ mm , frequency of @Hz , and peak acceleration of @ m/s@ .


Each vibration training session consisted of @ series of @s on with @s rest period in between .


The control group underwent the same statically mini-squatting position without exposure to WBV .


The effectiveness of the vibration program was evaluated by vertical jump test and the isokinetic knee extensor peak torque .


The possible neural factors that contributed to the improved muscular performance were evaluated by the stretch induced knee jerk reflex .


WBV training significantly enhanced the isokinetic knee extensor peak torque performance .


Two-way mixed repeated measures analysis of variance revealed significant time effect of the changes in the peak torque ( P = @ ) and the effect was significantly different between the intervention and control group ( P = @ ) .


WBV did not affect vertical jump height , reflex latency of VL , EMGVL , and knee jerk angle .


The results of this study do not support the hypothesis that the improvement in the muscular performance when subjects exposed to WBV training is attributed by neuromuscular efficiency via modulation of the muscle spindle sensitivity .


To compare anatomical and patient-reported outcomes at @ months postoperatively for women who had anterior compartment pelvic organ prolapse ( POP ) surgery using a repair augmented with porcine small intestine submucosa mesh ( Mesh Group ) compared with those who had a native tissue repair ( No Mesh Group ) .


This was a randomized controlled trial with @ months follow-up .


The surgical procedure was identical in both groups except for the placement of intervening mesh .


The primary outcome was anatomical `` cure '' ( Ba of -@ or less on Pelvic Organ Prolapse Quantification -LSB- POP-Q -RSB- ) .


Secondary outcomes included POP-Q stage , patient-reported outcomes , and patient satisfaction .


The study was powered to detect a @ % difference at @ % power ( = @ ) .


Fifty-seven women were randomized ( @ to Mesh Group , @ to No Mesh Group ) .


Forty-five ( @ % ) underwent concomitant surgery .


At the @-month follow-up , @ % ( @/@ ) in the Mesh Group and @ % ( @/@ ) in the No Mesh Group were considered cured ( relative risk @ , @ % confidence interval @-@ @ ) .


There were no significant differences between groups in recurrent or persistent prolapse ( @ % in each group ) nor in patient-reported outcomes at @ months .


Pelvic girdle pain occurred in @ of @ in the Mesh Group and @ of @ in the No Mesh Group .


No significant differences were observed in anatomical or patient-reported outcomes outcome parameters at @ months after correction of symptomatic anterior POP by mesh or no mesh repair .


In our study , porcine small intestine submucosa mesh did not confer additional benefit over a native tissue repair .


Generalized Anxiety Disorder ( GAD ) is a high prevalence , chronic disorder .


Web-based interventions are acceptable , engaging , and can be delivered at scale .


Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety , or the factors that improve effectiveness and engagement .


The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults , and to determine the role of telephone and email reminders .


A @-arm randomized controlled trial with @ Internet users in the community , recruited via the Australian Electoral Roll , was conducted with @ - and @-month follow-up .


Five interventions were offered over a @-week period .


Group @ ( Active website ) received a combined intervention of psycho-education , Internet-delivered Cognitive Behavioral Therapy ( ICBT ) for anxiety , physical activity promotion , and relaxation .


Group @ ( Active website with telephone ) received the identical Web program plus weekly telephone reminder calls .


Group @ ( Active website with email ) received the identical Web program plus weekly email reminders .


Group @ ( Control ) received a placebo website .


Group @ ( Control with telephone ) received the placebo website plus telephone calls .


Main outcome measures were severity of anxiety symptoms as measured by the GAD @-item scale ( GAD-@ ) ( at post-test , @ , and @ months ) .


Secondary measures were GAD caseness , measured by the Mini International Neuropsychiatric Interview ( MINI ) at @ months , Centre for Epidemiologic Studies-Depression scale ( CES-D ) , Anxiety Sensitivity Index ( ASI ) , Penn State Worry Questionnaire ( PSWQ ) , and Days out of Role .


GAD-@ symptoms reduced over post-test , @-month , and @-month follow-up .


There were no significant differences between Group @ ( Control ) and Groups @ ( Active website ) , @ ( Active website with telephone ) , @ ( Active website with email ) , or @ ( Control with telephone ) at any follow-up .


A total of @ cases of GAD were identified at @ months , comprising @ % ( @/@ ) from the Active groups ( @ , @ , @ ) and @ % ( @/@ ) from the Control groups ( @ , @ ) , a difference that was not significant .


CES-D , ASI , and PSWQ scores were significantly lower for the active website with email reminders at post-test , relative to the control website condition .


Indicated prevention of GAD was not effective in reducing anxiety levels , measured by GAD-@ .


There were significant secondary effects for anxiety sensitivity , worry , and depression .


Challenges for indicated prevention trials are discussed .


Low levels of vitamin D are associated with asthma severity , airway remodeling , and exacerbation rate increase , especially in nonatopic asthma .


Reduced steroid responsiveness or impaired antimicrobial defense might be underlying mechanisms .


We sought to evaluate the effect of vitamin D supplementation on eosinophilic and neutrophilic airway inflammation in patients with nonatopic asthma .


In a double-blind , randomized , placebo-controlled trial , we investigated the effect of long-acting vitamin D@ ( @,@ IU ) on sputum neutrophils and eosinophils in @ patients with nonatopic asthma with neutrophilic ( @ % ) and/or eosinophilic ( @ % ) airway inflammation .


Sputum induction was performed at baseline and after @ weeks .


Other measurements included questionnaires , blood samples , and pulmonary function .


Treatment with vitamin D did not significantly affect sputum neutrophils or eosinophils compared with treatment with placebo in the total group .


Regarding sputum eosinophils , the effect of vitamin D appeared to be dependent on baseline sputum eosinophil levels ( interaction P = @ ) .


In patients with eosinophil levels of @ % or more ( median in patients with sputum eosinophilia , > @ % ) , eosinophils decreased from a median of @ % to @ % after vitamin D treatment as compared with an increase from @ % to @ % in patients receiving placebo ( P = @ ) .


Vitamin D treatment also resulted in slightly better Asthma Control Questionnaire scores ( P = @ ) .


Vitamin D supplementation reduced eosinophilic airway inflammation in patients with nonatopic asthma with severe eosinophilic airway inflammation , but did not affect sputum neutrophils .


Also , a small effect on asthma control was observed .


These findings suggest that vitamin D might have potential as an add-on treatment option in eosinophilic asthma .


To perform high-quality cardiopulmonary resuscitation ( CPR ) , high-quality chest compression and ventilation support should be performed .


However , many providers still have not maintained an adequate ventilation rate but hyperventilated during CPR .


Thus , this study was conducted to verify that the compression-adjusted ventilation ( CAV ) would be a more accurate ventilation method compared with the conventional ventilation ( CV ) .


Volunteer medical students and emergency medical services personnel were recruited .


They were randomly divided into either the CV group or the CAV group .


In the CV group , participants performed ventilation with estimation of the rate of @ to @ per minute ( @ ventilation/@ -@ seconds ) .


In the CAV group , the ventilation rate was adjusted in line with the compression rate ( compression : ventilation , @:@ ) .


In each group , @-rescuer adult CPR was performed on a manikin , which was intubated with an endotracheal tube , during a period of @ minutes .


The compression rate and the ventilation rate were recorded during CPR .


Data on @ medical students and @ emergency medical services personnel were analyzed .


No significant difference was observed in compression rate ( P = @ ) ; however , median ( interquartile range ) ventilation rate differed significantly between the CV and CAV groups ( @ -LSB- @ -RSB- per minute vs @ -LSB- @ -RSB- per minute , P = @ ) .


In addition , compared with the CV group , adequacy of ventilation rate was better in the CAV group ( @ % vs @ % , P < @ ) .


In comparison with the CV , the CAV is a more accurate method for maintenance of an adequate ventilation rate .


To identify a molecular signature that could be predictive of the clinical response to rituximab ( RTX ) and elucidate the transcriptomic changes after RTX therapy in patients with rheumatoid arthritis ( RA ) , with the use of whole-blood transcriptomic profiling .


A microarray assay of the whole human genome was performed using RNA from peripheral blood samples obtained before the first cycle of RTX from @ patients with RA in the SMART study .


The transcriptomic profile was also assessed @ weeks after the first administration of RTX ( among @ nonresponders and @ responders , according to the European League Against Rheumatism response criteria at week @ ) .


Ingenuity Interactive Pathways Analysis was used to identify molecular pathways that were modified by RTX therapy according to the clinical response .


Quantitative polymerase chain reaction was performed to confirm the microarray results .


In total , @ genes showed significant baseline differential expression between patient groups according to their subsequent response to RTX ( good or moderate responder versus nonresponder ) .


This molecular signature could be reduced to @ genes , which allowed for correctly classifying @ % of the patients by their EULAR response status at week @ , with @ % identification of responders and @ % identification of nonresponders .


The signature for response featured up-regulation of inflammatory genes centered on NF-B , including IL@ and STAT@A , and down-regulation of the interferon pathway .


As expected , at week @ post-RTX therapy , genes involved in the development and functions of B cells were the genes most strongly down-regulated , without any difference between the @ groups .


Whole-blood transcriptomic analyses may accurately identify patients with RA who will not respond to RTX therapy .


These findings could open new perspectives on the clinical management of RA .


Existing data are not consistently supportive of improved clinical outcome when vancomycin dosing regimens aimed at achieving target trough levels are used .


A retrospective , post hoc , subgroup analysis of prospectively collected data from the Phase @ ATTAIN trials of telavancin versus vancomycin for treatment of nosocomial pneumonia was conducted to further investigate the relationship between vancomycin serum trough levels and patient outcome .


Study patients were enrolled in @ study sites across @ countries .


A total of @ patients had Staphylococcus aureus nosocomial pneumonia and vancomycin serum trough levels available .


These patients were grouped according to their median vancomycin trough level ; < @g/mL , @g/mL to < @g/mL , and@g/mL .


Clinical cure rates in the < @g/mL , @g/mL to < @g/mL , and@g/mL vancomycin trough level groups were @ % ( @/@ ) , @ % ( @/@ ) , and @ % ( @/@ ) , respectively ( p = @ ) , and the frequencies of patient death were @ % ( @/@ ) , @ % ( @/@ ) , and @ % ( @/@ ) , respectively ( p = @ ) .


Renal adverse events were more frequent in the@g/mL ( @ % -LSB- @/@ -RSB- ) than the < @g/mL ( @ % ) and @g/mL to < @g/mL ( @ % -LSB- @/@ -RSB- ) trough level groups ( p < @ ) .


When patients with acute renal failure or vancomycin exposure within @days prior to study medication were excluded , clinical cure rates in the < @g/mL , @g/mL to < @g/mL , and@g/mL vancomycin trough level groups ( @ % -LSB- @/@ -RSB- , @ % -LSB- @/@ -RSB- , and @ % -LSB- @/@ -RSB- , respectively ; p = @ ) and the number of deaths ( @ % -LSB- @/@ -RSB- , @ % -LSB- @/@ -RSB- , and @ % -LSB- @/@ -RSB- , respectively ; p = @ ) demonstrated a trend towards worse outcomes in the higher vancomycin trough level groups .


The findings of our study suggest that higher vancomycin trough levels do not result in improved clinical response but likely increase the incidence of nephrotoxicity .


As evidence suggests visit-to-visit variability ( VVV ) of blood pressure ( BP ) is associated with cardiovascular events and mortality , there is increasing interest in identifying interventions that reduce VVV of BP .


We investigated the effects of weight loss and sodium reduction , alone or in combination , on VVV of BP in participants enrolled in phase II of the Trials of Hypertension Prevention .


BP readings were taken at @-month intervals for @ months in @ participants with high-normal DBP who were randomized to weight loss , sodium reduction , combination ( weight loss and sodium reduction ) , or usual care groups .


VVV of BP was defined as the SD of BP across six follow-up visits .


VVV of SBP was not significantly different between participants randomized to the weight loss ( @ mmHg ) , sodium reduction ( @ mmHg ) , or combined ( @ mmHg ) intervention groups vs. the usual care group ( @ mmHg ) .


In a fully adjusted model , no difference ( @ mmHg ) in VVV of SBP was present between individuals who successfully maintained their weight loss vs. individuals who did not lose weight during follow-up ( P = @ ) .


Also , those who maintained a reduced sodium intake throughout follow-up did not have lower VVV of SBP compared to those who did not reduce their sodium intake ( @ mmHg ; P = @ ) .


Results were similar for VVV of DBP .


These findings suggest that weight loss and sodium reduction may not be effective interventions for lowering VVV of BP in individuals with high-normal DBP .


Concurrent chemoradiotherapy ( CCRT ) is the standard treatment for patients with unresectable , nonmetastatic locoregionally advanced squamous-cell carcinoma of the head and neck ( LASCCHN ) .


This randomized , open-label , phase III clinical trial compared the efficacy between standard CCRT and two different induction chemotherapy ( ICT ) regimens followed by CCRT .


Patients with untreated LASCCHN were randomly assigned to ICT ( three cycles ) , with either docetaxel ( Taxotere ) , cisplatin and @-fluorouracil ( TPF arm ) or cisplatin and @-fluorouracil ( PF arm ) , followed by CCRT -LSB- @ weeks of radiotherapy ( RT ) with cisplatin @ mg/m ( @ ) on days @ , @ and @ -RSB- ; or @ weeks of CCRT alone .


The primary end points were progression-free survival ( PFS ) and time-to-treatment failure ( TTF ) .


In the intention-to-treat ( ITT ) population ( n = @ ) , the median PFS times were @ ( @ % CI , @-@ @ ) , @ ( @ % CI , @-@ @ ) and @ months ( @ % CI , @-@ @ ) at TPF-CCRT , PF-CCRT and CCRT arms , respectively ( log-rank P = @ ) .


The median TTF were @ ( @ % CI , @-@ @ ) , @ ( @ % CI , @-@ @ ) and @ months ( @ % CI , @-@ @ ) for TPF-CCRT , PF-CCRT and CCRT alone , respectively ( log-rank P = @ ) .


There were no statistically significant differences for overall survival ( OS ) .


Toxic effects from ICT-CCRT were manageable .


Overall , this trial failed to show any advantage of ICT-CCRT over CCRT alone in patients with unresectable LASCCHN .


Recent studies indicate that glucagon-like peptide ( GLP ) -@ regulates bone turnover , but the effects of GLP-@ receptor agonists ( GLP-@ RAs ) on bone in obese weight-reduced individuals are unknown .


To investigate the role of GLP-@ RAs on bone formation and weight loss-induced bone mass reduction .


Randomized control study .


Outpatient research hospital clinic .


Thirty-seven healthy obese women with body mass index of @ @ kg/m ( @ ) and age @ @ years .


After a low-calorie-diet-induced @ % weight loss , participants were randomized to treatment with or without administration of the GLP-@ RA liraglutide ( @ mg/d ) for @ weeks .


In case of weight gain , up to two meals per day could be replaced with a low-calorie-diet product to maintain the weight loss .


Total , pelvic , and arm-leg bone mineral content ( BMC ) and bone markers -LSB- C-terminal telopeptide of type @ collagen ( CTX-@ ) and N-terminal propeptide of type @ procollagen ( P@NP ) -RSB- were investigated before and after weight loss and after @-week weight maintenance .


Primary endpoints were changes in BMC and bone markers after @-week weight maintenance with or without GLP-@ RA treatment .


Total , pelvic , and arm-leg BMC decreased during weight maintenance in the control group ( P < @ ) , but not significantly in the liraglutide group .


Thus , total and arm-leg BMC loss was four times greater in the control group compared to the liraglutide group ( estimated difference , @ g ; @ % confidence interval , @-@ ; P = @ ) , although the @ % weight loss was maintained in both groups .


In the liraglutide group , the bone formation marker P@NP increased by @ % ( @ @ g/L ) vs a @ % ( -@ @ g/L ) decrease in the control group ( P < @ ) .


The bone resorption marker CTX-@ collagen did not change during the weight loss maintenance phase .


Treatment with a long-acting GLP-@ RA increased bone formation by @ % and prevented bone loss after weight loss obtained through a low-calorie diet , supporting its role as a safe weight-lowering agent .


To assess the impact of domicile-based humidification on symptom burden during radiation therapy ( RT ) for head-and-neck ( H&N ) cancer .


From June @ through June @ , @ patients with H&N cancer receiving RT were randomized to either a control arm or to receive humidification using the Fisher & Paykel Healthcare MR@ humidifier .


Humidification commenced on day @ of RT and continued until Common Terminology Criteria for Adverse Events ( CTCAE ) , version @ , clinical mucositis ( CMuc ) grade @ occurred .


Forty-three patients ( @ % ) met a defined benchmark for humidification compliance and contributed to per protocol ( PP ) analysis .


Acute toxicities , hospitalizations , and feeding tube events were recorded prospectively .


The McMaster University Head and Neck Radiotherapy Questionnaire ( HNRQ ) was used for patient-reported outcomes .


The primary endpoint was area under the curve ( AUC ) for CMuc grade @ .


There were no significant differences in AUC for CMuc @ between the @ arms .


Humidification patients had significantly fewer days in hospital ( P = @ ) .


In compliant PP patients , the AUC for CTCAE functional mucositis score ( FMuc ) @ was significantly reduced ( P = @ ) , and the proportion who never required a feeding tube was significantly greater ( P = @ ) .


HNRQ PP analysis estimates also in the direction favoring humidification with less symptom severity , although differences at most time points did not reach significance .


TROG @ has provided efficacy signals consistent with a role for humidification in reducing symptom burden from mucositis , but the influence of humidification compliance on the results moderates recommendations regarding its practical utility .


New clinical research findings may require clinicians to change their behaviour to provide high-quality care to people with type @ diabetes , likely requiring them to change multiple different clinical behaviours .


The present study builds on findings from a UK-wide study of theory-based behavioural and organisational factors associated with prescribing , advising , and examining consistent with high-quality diabetes care .


To develop and evaluate the effectiveness and cost of an intervention to improve multiple behaviours in clinicians involved in delivering high-quality care for type @ diabetes .


We will conduct a two-armed cluster randomised controlled trial in @ general practices in the North East of England to evaluate a theory-based behaviour change intervention .


We will target improvement in six underperformed clinical behaviours highlighted in quality standards for type @ diabetes : prescribing for hypertension ; prescribing for glycaemic control ; providing physical activity advice ; providing nutrition advice ; providing on-going education ; and ensuring that feet have been examined .


The primary outcome will be the proportion of patients appropriately prescribed and examined ( using anonymised computer records ) , and advised ( using anonymous patient surveys ) at @months .


We will use behaviour change techniques targeting motivational , volitional , and impulsive factors that we have previously demonstrated to be predictive of multiple health professional behaviours involved in high-quality type @ diabetes care .


We will also investigate whether the intervention was delivered as designed ( fidelity ) by coding audiotaped workshops and interventionist delivery reports , and operated as hypothesised ( process evaluation ) by analysing responses to theory-based postal questionnaires .


In addition , we will conduct post-trial qualitative interviews with practice teams to further inform the process evaluation , and a post-trial economic analysis to estimate the costs of the intervention and cost of service use .


Consistent with UK Medical Research Council guidance and building on previous development research , this pragmatic cluster randomised trial will evaluate the effectiveness of a theory-based complex intervention focusing on changing multiple clinical behaviours to improve quality of diabetes care .


To compare local infiltration anesthesia ( LIA ) and peripheral nerve block ( PNB ) in repairing hand lacerations .


This prospective study was designed as a randomized , controlled , unblinded trial .


Fifty four patients with hand lacerations were included in the study .


While @ of these patients had LIA , PNB was performed in the remaining @ patients .


Lidocaine hydrochloride @ % and @ gauge needles were used .


Onset time of the anesthesia , response to the injection and suturing procedures , need for additional anesthetic , and patient satisfaction were compared .


No significant differences were noted between the groups in terms of response to injection pain and suture pain ( Mann-Whitney U ; P = @ / P = @ ) .


There were also no significant differences between the groups when patient satisfaction ( chi-square ; P = @ ) and need for additional local anesthetics ( Fisher 's exact ; P = @ ) were evaluated .


The time to loss of pinprick sensation in the local infiltration group was @ min , whereas in the nerve block group it was @ min .


The difference was statistically significant ( Mann-Whitney U ; P < @ ) .


Despite the fact that performing PNB in emergency departments requires some experience , it still counts as a convenient method comparable to LIA .


Primary goal of this randomized , double-blind , placebo-controlled crossover study of Renadyl in end-stage renal disease patients was to assess the safety and efficacy of Renadyl measured through improvement in quality of life or reduction in levels of known uremic toxins .


Secondary goal was to investigate the effects on several biomarkers of inflammation and oxidative stress .


Two @-month treatment periods separated by @-month washout and crossover , with physical examinations , venous blood testing , and quality of life questionnaires completed at each visit .


Data were analyzed with SAS V@ @ .


@ subjects ( @ % ) completed the study .


Observed trends were as follows ( none reaching statistical significance ) : decline in WBC count ( -@ @ ( @ ) / L , P = @ ) and reductions in levels of C-reactive protein ( -@ mg/L , P = @ ) and total indoxyl glucuronide ( -@ mg % , P = @ ) .


No statistically significant changes were observed in other uremic toxin levels or measures of QOL .


Renadyl appeared to be safe to administer to ESRD patients on hemodialysis .


Stability in QOL assessment is an encouraging result for a patient cohort in such advanced stage of kidney disease .


Efficacy could not be confirmed definitively , primarily due to small sample size and low statistical power-further studies are warranted .


Cancer-related fatigue is a multidimensional symptom with an underestimated prevalence and severity in cancer patients .


The aim of the study was to evaluate the effect of dance as a holistic sportive activity in cancer patients under active anticancer treatment with fatigue as endpoint .


Forty patients under active anticancer treatment ( adjuvant ( @ ) , palliative ( @ ) or neoadjuvant ( @ ) ) with moderate or severe fatigue ( @ on the visual analogue scale ) were investigated in two groups for severity of fatigue ( visual analogue scale , Functional Assessment of Chronic Illness Therapy : Fatigue questionnaire ) , quality of life ( European Organization for Research and Treatment of Cancer , Quality of Life Questionnaire ) and physical performance ( @-minute walk test ) before and after the study period -- group A ( n = @ ) : intervention ( @ dance classes in @ weeks in addition to counselling ) and group B ( n = @ ) : control ( no dance , standard of care , counselling ) .


We found significant improvements for cancer-related fatigue in the intervention group ( baseline mean SD @ @ , end-of-study mean @ @ , p = @ , reduction of @ % ) compared to the control group ( baseline mean @ @ , end-of-study mean unchanged at @ @ , p = @ ) ; as well as for emotional and social functioning scales and physical performance ( p < @ ) .


Dance might be an appropriate , effective approach for treatment of cancer-related fatigue .


Aphasia is a common and severely disabling complication in stroke patients .


It usually brings about lower rates of functional recovery , longer rehabilitation length of stay ( LOS ) , and significantly poorer LOS efficiency ( LOS-Eff ) , resulting in higher rehabilitation costs compared to patients without aphasia .


It also decreases the quality of life and increases the mortality of stroke patients .


The evidence currently available suggests that the effect of acupuncture combined with language training for apoplectic aphasia is statistically better than speech and language therapy ( SLT ) alone , but there remains a lack of high-quality randomized controlled trials .


Acupuncture combined with language training is relatively low-cost and especially suitable for community-based rehabilitation for aphasia patients after stroke , taking its medical and health facilities which are always deficient in manpower and material resources into account .


The aim of the present study is to develop an effective standard therapeutic program for apoplectic aphasia in communities .


In a randomized controlled clinical trial with blinded assessment , @ eligible patients with aphasia due to stroke will be randomly allocated into a control group or an experimental group .


The course of this trial will comprise a @-week intervention and a @-week follow-up period .


Five assessment points , including baseline , @ and @weeks after treatment , @ and @weeks after follow-up , are set to dynamically observe the changes of curative effects .


Primary outcome measures are the differences in the score on both the China rehabilitation research center aphasia examination ( CRRCAE ) and Boston diagnostic aphasia examination - Chinese version ( BDAE-C ) after intervention and follow-up .


The Modified Barthel Index ( MBI ) , @-Item Short Form Health Survey ( SF-@ ) , and results of blood oxygen level dependent-functional magnetic resonance imaging ( BOLD-fMRI ) examination are considered as the secondary outcome measures .


Other outcomes will include rate of adverse events and economic effects .


If the outcome is positive , this project will offer a low-cost appropriate technology for community health centers ( CHCs ) in the rehabilitation of aphasia patients after stroke , and could be implemented on a large scale , both in China and worldwide .


To examine the relationship of choroidal thickness with axial length ( AL ) and myopia in young adult eyes in the ethnically diverse Correction of Myopia Evaluation Trial ( COMET ) cohort .


Cross-sectional , multicenter study .


In addition to measures of myopia by cycloplegic autorefraction and AL by A-scan ultrasonography , participants underwent optical coherence tomography imaging of the choroid in both eyes at their last visit ( @ years after baseline ) .


Using digital calipers , @ independent readers measured choroidal thickness in the right eye ( left eye if poor quality ; n = @ ) at @ locations : fovea and @ , @ , and @ m nasal ( N ) and temporal ( T ) to the fovea .


Choroidal thickness measurements were available from @ of @ ( @ % ) imaged participants ( mean age : @ @ years ; @ % male ) with mean myopia of -@ @ diopters and mean AL of @ @ mm .


Overall , choroidal thickness varied by location ( P < @ ) and was thickest at the fovea ( @ @ m ) and thinnest nasally ( N@ , @ @ m ) .


Multivariable analyses showed significantly thinner choroids in eyes with more myopia and longer AL at all locations except T@ ( P @ ) and presence of peripapillary crescent at all locations except T@ and T@ ( P @ ) .


Choroidal thickness varied by ethnicity at N@ ( P < @ ) , with Asians having the thinnest and African Americans the thickest choroids .


Choroids are thinner in longer , more myopic young adult eyes .


The thinning was most prominent nasally and in eyes with a crescent .


In the furthest nasal location , ethnicity was associated with choroidal thickness .


The findings suggest that choroidal thickness should be evaluated , especially in the nasal regions where myopic degenerations are most commonly seen clinically .


Blinding is a fundamental design strengthening feature in randomized clinical trials .


Blinding is particularly important in trials whose outcome measures include subjective assessment of signs and symptoms , such as trials investigating the post-thrombotic syndrome , a frequent chronic complication of deep vein thrombosis .


To determine whether strategies used to blind site investigators , research coordinators and patients were successful in a specific device trial , a multicenter trial of active versus placebo elastic compression stockings worn for @ years to prevent post-thrombotic syndrome in patients with a first deep vein thrombosis ( the SOX Trial ) .


Patients were randomized to the active or placebo stocking intervention , which were indistinguishable in appearance at baseline .


Replacement stockings were shipped directly to patients ' homes and were not worn to any of the study visits during the study .


Guesstimates of treatment group assignment were completed by site investigators , research coordinators and patients at the end of study follow-up .


Statistical assessments of blinding were performed using the James and Bang blinding indices .


Overall rates of correct responses were @ % for site investigators , @ % for research coordinators and @ % for patients .


James blinding index values suggest that blinding was achieved for site investigators , research coordinators and patients .


The treatment specific Bang blinding index values suggest that blinding was achieved for site investigators and research coordinators , but detected possible unblinding and opposite guess for patients in the active and placebo elastic compression stocking groups , respectively .


Post-study assessment of blinding , as was done for the SOX Trial , can not distinguish between degree of blinding and hunches about an intervention 's efficacy .


However , as rates of post-thrombotic syndrome along with adverse events in the SOX Trial were similar between treatment groups , it is unlikely that hunches would have interfered with our end-of-trial assessment for blinding .


Blinding strategies used in our trial were successful overall and appeared to be most effective for site investigators and research coordinators .


For patients , there may have been some degree of unblinding in the active stocking group .


However , as the trial results were negative with active elastic compression stocking showing no benefit over placebo elastic compression stocking , this potential unblinding has minimal impact on the overall conclusions of the trial .


The survival rate of patients with out-of-hospital cardiac arrest is low , and measures to improve the quality of cardiopulmonary resuscitation ( CPR ) during ambulance transportation are desirable .


We designed a stabilization device , and in a randomized crossover trial we found performing CPR in a moving ambulance with the device ( MD ) could achieve better efficiency than that without the device ( MND ) , but the efficiency was lower than that in a non-moving ambulance ( NM ) .


To evaluate whether a modified version of the stabilization device , can promote further the quality of CPR during ambulance transportation .


Participants of the previous study were recruited , and they performed CPR for @ minutes in a moving ambulance with the modified version of the stabilization device ( MVSD ) .


The primary outcomes were effective chest compressions and no-flow fraction recorded by a skill-reporter manikin .


The secondary outcomes included back pain , physiological parameters , and the participants ' rating about the device after performing CPR .


The overall effective compressions in @ minutes were @ % for NM , @ % for MND , @ % for MD , and @ % @ % for MVSD ( p < @ ) .


Whereas changes in back pain severity and physiology parameters were similar under all conditions , MVSD had the lowest no-flow fraction .


Differences in effective compressions and the no-flow fraction between MVSD and NM did not reach statistical significance .


The use of the modified device can improve quality of CPR in a moving ambulance to a level similar to that in a non-moving condition without increasing the severity of back pain .


Volume of para-esophageal varices ( PEV ) correlates with esophageal varices recurrence .


The effect of propranolol on volumetric change of PEV has not been studied .


The relation between EV recurrence and volumetric change of PEV in patients undergoing endoscopic variceal ligation ( EVL ) with and without propranolol are studied .


Sixty-six patients who achieved EV eradication by primary EVL were randomly allocated to a propranolol group ( n = @ ) or control group ( n = @ ) .


The endpoints of the study were EV recurrence and volumetric change of PEV assessed by using endoscopic ultrasonography ( EUS ) at @-month intervals for @ years .


The cumulative probability of recurrence at two years was @ % in the propranolol group ( n = @ ) and @ % in the control group ( n = @ ) ( p = @ , log-rank test ) .


Difference of the volumetric change of PEV became significant as early as at the third month -LSB- -@ ( -@ -@ ) vs. @ ( -@ -@ ) , p < @ -RSB- between the two groups .


Regression of PEV was achieved in @ patients of the propranolol group at a median time of three months ( range @-@ months ) , and no EV recurrence was found at the end of follow-up for two years .


On multivariate analysis , the volumetric change of PEV at the third month and use of propranolol were determinants of EV recurrence .


Propranolol may reduce both EV recurrence rate and volume of PEV in patients achieving endoscopic eradication .


Regression of PEV is a predictor of durable eradication of EV without recurrence in patients using propranolol .


EUS is an objective and useful tool to measure PEV and predict recurrence of EV .


Gut dysfunctions may be associated to digestive symptoms .


We hypothesized that the gut can also originate pleasant sensations , and wished to demonstrate the hedonic component of the digestive response to a meal .


Healthy subjects ( n = @ ) were evaluated during basal fasting conditions and during experimentally induced fullness sensation ( either by gastric distension or duodenal nutrient infusion ) .


In each set of studies , a @ mL test meal ( @ kcal broth ) and water , as inert control meal , were administered on separate days in a randomized , cross-over design .


Gastric accommodation , the cognitive response and the hedonic dimension ( both by @ score scales ) were measured @ min before and @ min after the meal .


In basal conditions , the test meal induced a significantly greater gastric relaxation than the control meal ( @ @ mL isotonic volume increase @ @ mL ; p = @ ) .


Both meals induced epigastric fullness ( @ @ score and @ @ score , respectively ; p = @ ) , but contrary to the inert meal , with the active meal this conscious sensation had a pleasant dimension ( digestive comfort increase by @ @ score with active meal vs -@ @ decrease with inert meal ; p = @ ) .


Experimentally induced fullness was associated to a decrease in digestive well-being or abdominal discomfort , which improved only after the active meal but not the inert meal .


When appropriate conditions are met , the response to a meal includes a hedonic dimension involving pleasant sensation of digestive well-being .


Enzalutamide significantly increased overall survival and radiographic progression-free survival compared with placebo in the PREVAIL trial of asymptomatic and minimally symptomatic , chemotherapy-naive patients with metastatic castration-resistant prostate cancer .


We report the effect of enzalutamide on health-related quality of life ( HRQoL ) , pain , and skeletal-related events observed during this trial .


In this phase @ , double-blind trial , patients were randomly assigned ( @:@ ) to receive enzalutamide @ mg/day ( n = @ ) or placebo ( n = @ ) orally .


HRQoL was assessed at baseline and during treatment using the Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) and EQ-@D questionnaires .


Pain status was assessed at screening , baseline , week @ , and week @ with the Brief Pain Inventory Short Form ( BPI-SF ) .


The primary analysis of HRQoL data used a mixed-effects model to test the difference between least square means change from baseline at week @ .


We assessed change from baseline , percentage improvement , and time to deterioration in HRQoL and pain , the proportion of patients with a skeletal-related event , and time to first skeletal-related event .


Analysis was done on the intention-to-treat population .


This study is registered with ClinicalTrials.gov , number NCT@ .


Median treatment duration was @ months ( IQR @-@ ) in the enzalutamide group and @ months ( @-@ ) in the placebo group .


The mixed-effects model analyses showed significant treatment differences in change from baseline to week @ with enzalutamide compared with placebo for most FACT-P endpoints and EQ-@D visual analogue scale .


Median time to deterioration in FACT-P total score was @ months ( @ % CI @-@ ) in the enzalutamide group and @ months ( @-@ ) in the placebo groups ( hazard ratio -LSB- HR -RSB- @ -LSB- @ % CI @-@ -RSB- ; p < @ ) .


A significantly greater proportion of patients in the enzalutamide group than in the placebo group reported clinically meaningful improvements in FACT-P total score ( @ -LSB- @ % -RSB- of @ vs @ -LSB- @ % -RSB- of @ ) , in EQ-@D utility index ( @ -LSB- @ % -RSB- of @ vs @ -LSB- @ % -RSB- of @ ) , and visual analogue scale ( @ -LSB- @ % -RSB- of @ vs @ of -LSB- @ % -RSB- @ ; all p < @ ) .


Median time to progression in BPI-SF pain at its worst was @ months ( @ % CI @-@ ) in the enzalutamide group and @ months ( @-@ ) in the placebo group ( HR @ -LSB- @ % CI @-@ -RSB- ; p < @ ) .


Progression of pain at its worst was less common in the enzalutamide group than in the placebo group at week @ ( @ -LSB- @ % -RSB- of @ vs @ -LSB- @ % -RSB- of @ ; p < @ ) , but not at week @ ( @ -LSB- @ % -RSB- of @ vs @ -LSB- @ % -RSB- of @ ; p = @ ) .


@ ( @ % ) of @ patients in the enzalutamide group and @ ( @ % ) of @ patients in the placebo group had experienced a skeletal-related event by data cutoff .


Median time to first skeletal-related events in the enzalutamide group was @ months ( @ % CI @-not reached ) and @ months ( @ % CI @-not reached ) in the placebo group ( HR @ -LSB- @ % CI @-@ -RSB- ; p < @ ) .


In addition to improving overall survival relative to placebo , enzalutamide significantly improves patient-related outcomes and delays occurrence of first skeletal-related event in chemotherapy-naive men with metastatic castration-resistant prostate cancer .


Heart failure ( HF ) continues to be a leading cause of hospital admissions , particularly in underserved patients .


We hypothesised that providing individualised self-management support to patients and feedback on use of evidence-based HF therapies ( EBT ) to physicians could lead to improvements in care and decrease hospitalisations .


To assess the feasibility of conducting a larger trial testing the efficacy of this dual-level intervention , we conducted the Congestive Heart failure Adherence Redesign Trial Pilot ( CHART-P ) , a proof-of-concept , quasi-experimental , feasibility pilot study .


A large tertiary care medical centre in Chicago .


Low-income patients ( < US$ @,@ / year ) hospitalised for exacerbation of systolic HF ( ejection fraction @ % ) and their physicians .


Twenty physicians and @ patients were enrolled , of whom @ patients completed the study .


Physicians received HF guidelines and periodic individualised feedback on their adherence to EBT .


Patients received HF education , support and self-management training for diet and medication adherence by a trained nurse through @ interactive sessions over a @-month period .


Evaluations were conducted pre-enrolment and @ month postintervention completion .


Feasibility was assessed by the ability to deliver intervention to patients and physicians .


Exploratory outcomes included changes in medication and sodium intake for patients and adherence to EBT for physicians .


Eighty-seven per cent and @ % of patients received > @ % of interventions at @ month and by study completion , respectively .


Median sodium intake declined ( @ vs @ g ; p < @ ) .


There was no statistically significant change in medication adherence based on electronic pill cap monitoring or the Morisky Medication Adherence Scale ( MMAS ) ; however , there was a trend towards improved adherence based on MMAS .


All physicians received timely intervention .


This pilot study demonstrated that the protocol was feasible .


It provided important insights about the need for intervention and the difficulties in treating patients with a variety of psychosocial problems that undercut their effective care .


Evidence indicates that center volume of cases affects outcomes for both carotid endarterectomy and stenting .


We evaluated the effect of enrollment volume by site on complication rates in the Carotid Revascularization Endarterectomy Versus Stenting Trial ( CREST ) .


The primary composite end point was any stroke , myocardial infarction , or death within @ days or ipsilateral stroke in follow-up .


The @ approved surgeons performed > @ procedures per year with complication rates < @ % for asymptomatic patients and < @ % for symptomatic patients ; @ interventionists were certified after a rigorous @ step credentialing process .


CREST centers were divided into tertiles based on the number of patients enrolled into the study , with Group @ sites enrolling < @ patients , Group @ sites enrolling @ to @ patients , and Group @ sites enrolling > @ patients .


Differences in periprocedural event rates for the primary composite end point and its components were compared using logistic regression adjusting for age , sex , and symptomatic status within site-volume level .


The safety of carotid angioplasty and stenting and carotid endarterectomy did not vary by site-volume during the periprocedural period as indicated by occurrence of the primary end point ( P = @ ) or by stroke and death ( P = @ ) .


A trend toward an inverse relationship between center enrollment volume and complications was mitigated by adjustment for known risk factors .


Complication rates were low in CREST and were not associated with center enrollment volume .


The data are consistent with the value of rigorous training and credentialing in trials evaluating endovascular devices and surgical procedures .


Depressive disorders are highly prevalent and result in negative consequences for both patients and society .


It is therefore important that these disorders are treated adequately .


However , due to increased demand for mental healthcare and subsequent increased costs , it would be desirable to reduce costs associated with major depressive disorder while maintaining or improving the quality of care within the healthcare system .


Introducing evidence-based online self-help interventions in mental healthcare might be the way to maintain clinical effects while minimizing costs by reducing the number of face-to-face sessions .


This study aims to evaluate the clinical and economical effects of a guided online self-help intervention when offered to patients with major depressive disorder on a waiting list for psychotherapy in specialized mental health centers ( MHCs ) .


Patients at mental health centers identified with a Diagnostic and Statistical Manual of Mental Disorders , fourth edition ( DSM-IV ) diagnosis of major depression who are awaiting face-to-face treatment are studied in a randomized controlled trial .


During this waiting list period , patients are randomized and either ( @ ) receive an internet-based guided self-help treatment or ( @ ) receive a self-help book .


The @-week internet-based guided self-help intervention and the self-help booklet are based on problem solving treatment .


After the intervention , patients are allowed to start regular face-to-face treatment at MHCs .


Costs and effects are measured at baseline , after the intervention at @ to @ weeks , @ months and @ months .


The primary outcome measure is symptoms of depression .


Secondary outcome measures are diagnosis of depression , number of face-to-face sessions , absence of work and healthcare uptake in general .


Additional outcome measures are anxiety , insomnia , quality of life and mastery .


This study evaluates the effectiveness and cost effectiveness of internet-based guided self-help in patients at specialized mental health centers .


The aim is to demonstrate whether the introduction of internet-based self-help interventions in regular mental healthcare for depressive disorders can maintain clinical effects and reduce costs .


Strengths and limitations of this study are discussed .


We determined the effectiveness of @ methods to treat overactive bladder in children using intragroup and intergroup comparisons in a randomized clinical trial .


Nine boys and @ girls with a mean SD age of @ years were randomly divided into group @-parasacral transcutaneous electrical stimulation with placebo drug and group @-oxybutynin with sham scapular electrical therapy .


Success was assessed by @ ) the rate of complete symptom resolution , @ ) a visual analog scale of @ to @ , @ ) the dysfunctional voiding score system , @ ) voiding diary records , @ ) Rome III criteria and @ ) side effect frequency in each group .


A total of @ and @ patients were randomized to groups @ and @ , respectively .


Symptoms completely resolved in @ patients in group @ ( @ % ) and @in group @ ( @ % ) ( p = @ ) .


A statistically significant improvement was found in the @ groups in the dysfunctional voiding score system and voiding diary records .


However , no statistically significant difference was found between the groups in the visual analog scale score , voiding frequency , and maximum and mean voided volume ( p = @ , @ , @ and @ , respectively ) .


Constipation improved in @ % of group @ patients but in only @ % in group @ ( p = @ vs @ ) .


Group @ showed no side effects while dry mouth , hyperthermia and hyperemia developed in @ % , @ % and @ % of group @ patients ( p = @ , @ and @ , respectively ) .


Treatment was discontinued by @ % of patients in group @ .


Parasacral transcutaneous electrical stimulation was as effective as oxybutynin to treat overactive bladder in children .


However , transcutaneous parasacral electrical stimulation was more effective against constipation and showed no detectable side effects .


Oxybutynin was more effective for decreasing voiding frequency .


To evaluate the efficacy of maropitant for prevention of vomiting and gastroesophageal reflux ( GER ) in dogs following acepromazine-hydromorphone premedication and inhalation anesthesia .


Randomized , blinded , prospective clinical study .


Twenty-six dogs admitted for elective soft tissue or orthopedic procedures that were @ @ years of age and weighed @ @ kg .


Dogs were randomly assigned to one of two groups : Group M received maropitant ( @ mg kg ( -@ ) ) and Group S received @ % saline ( @ mL kg ( -@ ) ) intravenously @-@ minutes before premedication with hydromorphone ( @ mg kg ( -@ ) ) and acepromazine ( @ mg kg ( -@ ) ) intramuscularly .


An observer blinded to treatment documented any retching or vomiting for @ minutes before induction with propofol ( @-@ mg kg ( -@ ) ) and inhalation anesthesia .


A pH probe inserted into the distal esophagus was used to detect GER .


None of the dogs in Group M retched or vomited ( @/@ ) , @/@ ( @ % ) in Group S were observed to retch or vomit , and the difference between groups was significant ( p = @ ) .


There were no differences between groups in the number of dogs with GER ( Group M : @/@ , Group S : @/@ dogs ) or the number of reflux events .


Esophageal pH at the end of anesthesia was significantly lower in both M and S groups in dogs with GER versus dogs without GER ( p = @ and @ , respectively ) .


Only dogs with GER in Group S had significantly lower pH at the end compared to the beginning of anesthesia ( p = @ ) .


Intravenous maropitant prevented retching and vomiting associated with acepromazine-hydromorphone premedication .


Maropitant did not prevent the occurrence of GER .


Fewer dogs in Group M developed GER but further study with a larger number of dogs is necessary to determine if there is a significant difference .


A large proportion of university students show symptoms of common mental disorders , such as depression , anxiety , substance use disorders and eating disorders .


Novel interventions are required that target underlying factors of multiple disorders .


To evaluate the efficacy of a transdiagnostic trait-focused web-based intervention aimed at reducing symptoms of common mental disorders in university students .


Students were recruited online ( n = @ , age : M = @ , SD = @ ) and categorised into being at high or low risk for mental disorders based on their personality traits .


Participants were allocated to a cognitive-behavioural trait-focused ( n = @ ) or a control intervention ( n = @ ) using computerised simple randomisation .


Both interventions were fully automated and delivered online ( trial registration : ISRCTN@ ) .


Participants were blinded and outcomes were self-assessed at baseline , at @ weeks and at @ weeks after registration .


Primary outcomes were current depression and anxiety , assessed on the Patient Health Questionnaire ( PHQ@ ) and Generalised Anxiety Disorder Scale ( GAD@ ) .


Secondary outcome measures focused on alcohol use , disordered eating , and other outcomes .


Students at high risk were successfully identified using personality indicators and reported poorer mental health .


A total of @ students completed the @-week follow-up and @ students completed the @-week follow-up .


Attrition was high across intervention groups , but comparable to other web-based interventions .


Mixed effects analyses revealed that at @-week follow up the trait-focused intervention reduced depression scores by @ ( p < @ , @ % CI -LSB- @ , @ -RSB- ) and anxiety scores by @ ( p = @ , @ % CI -LSB- @ , @ -RSB- ) in students at high risk .


In high-risk students , between group effect sizes were @ ( depression ) and @ ( anxiety ) .


In addition , self-esteem was improved .


No changes were observed regarding the use of alcohol or disordered eating .


This study suggests that a transdiagnostic web-based intervention for university students targeting underlying personality risk factors may be a promising way of preventing common mental disorders with a low-intensity intervention .


Arteriovenous fistulas ( AVFs ) are recommended for hemodialysis access when possible .


A noncannulatable but otherwise well functioning AVF leads to prolonged catheter dependency and frustration for the patient and the renal health care provider team .


Difficult cannulation patients include obese individuals in whom cannulation sites are too deep , and others with vein segments that are short , tortuous , or otherwise difficult to palpate .


The Venous Window Needle Guide for Salvage of AV Fistulae ( SAVE ) trial was designed to evaluate the efficacy and safety of the Venous Window Needle Guide ( VWING ; Vital Access Corp , Salt Lake City , Utah ) device for salvage of such noncannulatable AVFs that are otherwise functional .


The SAVE study included patients with an established and otherwise mature AVF , in whom an additional procedure would otherwise be necessary to establish reliable cannulation .


The VWING is a single-piece titanium device that allows repeated access of an AVF through a single puncture site ( buttonhole technique ) .


Inclusion criteria included mature AVFs @ to @ mm in depth with multiple failed attempts at cannulation or where the access could not be palpated .


The devices were implanted subcutaneously and sutured to the anterior wall of the mature fistula .


Study end points were reliable and successful cannulation and avoidance of adverse events during the @-month follow-up , implant technical success , and clinical cannulation success .


Enrollment included @ patients at @ trial sites with implantation of @ VWING devices .


Body mass index was @ to @ ( median , @ ) , @ ( @ % ) patients were female , and age was @ to @ ( median , @ ) years .


Forty ( @ % ) individuals were diabetic .


Thirty-three ( @ % ) patients were white , @ ( @ % ) black , and @ ( @ % ) patients were Hispanic , Pacific Islander , or Native American .


Three patients were excluded from data analysis for reasons unrelated to the device .


Successful AVF access was achieved using the VWING in @ ( @ % ) of the @ patients evaluated .


The rate of device-related serious adverse events was @ per patient-year ; each event was resolved leaving the AVF functional .


The rates of sepsis and study-related interventions were @ and @ per patient-year , respectively .


There were no study-related deaths .


One device was removed because of infection .


The AVF survival rate at @months was @ % .


The total number of study days was @ and the estimated number of device cannulations was@ .


The VWING was safe and effective in facilitating AVF cannulation for patients with an otherwise mature but noncannulatable fistula .


Pain control and early ambulation are two important postoperative goals .


Strategies that decrease morphine use while increasing ambulation have the potential to decrease postoperative complications .


In this study the authors sought to determine the effect of an abdominopelvic binder on postoperative morphine use , pain , and ambulation in the first day after surgery .


The authors randomly assigned @ patients undergoing abdominal gynecologic surgery to either binder or not after surgery .


Demographic data and surgical characteristics were collected .


Outcome variables included morphine use , pain score , time to ambulation , and number of ambulations .


A group at high risk for decreased mobility was identified and the binder increased the number of ambulatory events by @ % , @ % , and @ % in patients with vertical incisions , age over @ years , and complex surgeries , respectively .


Morphine use and pain scores were not significantly different .


The binder increased ambulations in the subset of patients at the highest risk for postoperative complications : elderly , cancer patients , and vertical incisions .


Routine use of the binder may benefit particularly high-risk gynecologic surgical patients .


There are several formulations of propofol available to the anesthesiologist for clinical use .


The aim of this study was to analyze the physicochemical properties , pharmacodynamic effect , and pharmaceutical and clinical equivalence of the reference drug propofol as well as a similar formulation .


Sixteen volunteers were enrolled in this randomized , double-blind , and paired study of Diprivan and Propovan formulations .


Formulations were given as target-controlled infusion with target concentration of @ g.mL ( -@ ) for @ minutes .


Variables studied were the area under the curve ( AUC ) of the bispectral index ( BIS ) graph regarding time , minimum BIS reached and time to reach it , and recovery time .


The two formulations were sent to analysis of particle size of lipid emulsion , surface potential , and active principle quantification .


There was no difference between the formulations when comparing AUC , minimum BIS reached and time to reach it .


The similar formulation recovery time was lower compared to the reference formulation ( eight and @ min , respectively , p = @ ) .


Mean particle size of lipid emulsion , surface potential , and active ingredient quantification were similar for both formulations .


There was no clinically significant difference between the use of propofol , reference Diprivan , and the similar Propovan during infusion .


However , the recovery time was longer with the reference drug .


Although analysis of both formulations studied show similar results regarding its physicochemical characterization , further studies should be conducted to justify this difference .


No treatment strategies have been demonstrated to be beneficial for the population for patients with heart failure ( HF ) and preserved ejection fraction ( EF ) .


The CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients ( CHAMPION ) trial was a prospective , single-blinded , randomized controlled clinical trial testing the hypothesis that hemodynamically guided HF management decreases decompensation leading to hospitalization .


Of the @ patients enrolled in the study , @ had left ventricular EF @ % ( average , @ % ) , @ patients had low left ventricular EF ( < @ % ; average , @ % ) , and @ patient had no documented left ventricular EF .


A microelectromechanical system pressure sensor was permanently implanted in all participants during right heart catheterization .


After implant , subjects were randomly assigned in single-blind fashion to a treatment group in whom daily uploaded pressures were used in a treatment strategy for HF management or to a control group in whom standard HF management included weight-monitoring , and pressures were uploaded but not available for investigator use .


The primary efficacy end point of HF hospitalization rate > @ months for preserved EF patients was @ % lower in the treatment group compared with control ( incidence rate ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) .


After an average of @ months of blinded follow-up , the hospitalization rate was @ % lower ( incidence rate ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) .


In response to pulmonary artery pressure information , more changes in diuretic and vasodilator therapies were made in the treatment group .


Hemodynamically guided management of patients with HF with preserved EF reduced decompensation leading to hospitalization compared with standard HF management strategies .


Most inspiratory muscle training ( IMT ) interventions in patients with chronic obstructive pulmonary disease ( COPD ) have been implemented as fully supervised daily training for @ minutes with controlled training loads using mechanical threshold loading ( MTL ) devices .


Recently , an electronic tapered flow resistive loading ( TFRL ) device was introduced that has a different loading profile and stores training data during IMT sessions .


The aim of this study was to compare the efficacy of a brief , largely unsupervised IMT protocol conducted using either traditional MTL or TFRL on inspiratory muscle function in patients with COPD .


Twenty patients with inspiratory muscle weakness who were clinically stable and participating in a pulmonary rehabilitation program were randomly allocated to perform @ weeks of either MTL IMT or TFRL IMT .


Participants performed @ daily home-based IMT sessions of @ breaths ( @-@ minutes per session ) at the highest tolerable intensity , supported by twice-weekly supervised sessions .


Adherence , progression of training intensity , increases in maximal inspiratory mouth pressure ( Pimax ) , and endurance capacity of inspiratory muscles ( Tlim ) were evaluated .


More than @ % of IMT sessions were completed in both groups .


The TFRL group tolerated higher loads during the final @ weeks of the IMT program , with similar effort scores on the @-Item Borg Category Ratio ( CR-@ ) Scale , and achieved larger improvements in Pimax and Tlim than the MTL group .


A limitation of the study was the absence of a study arm involving a sham IMT intervention .


The short and largely home-based IMT protocol significantly improved inspiratory muscle function in both groups and is an alternative to traditional IMT protocols in this population .


Participants in the TFRL group tolerated higher training loads and achieved larger improvements in inspiratory muscle function than those in the MTL group .


Too many young people engage in unhealthy behaviours such as eating unhealthily , being physically inactive , binge drinking and smoking .


This study aimed to estimate the short-term and long-term cost-effectiveness of a theory-based online health behaviour intervention ( `` U@Uni '' ) in comparison with control in young people starting university .


A costing analysis was conducted to estimate the full cost of U@Uni and the cost of U@Uni roll-out .


The short-term cost-effectiveness of U@Uni was estimated using statistical analysis of @-month cost and health-related quality of life data from the U@Uni randomised controlled trial .


An economic modelling analysis combined evidence from the trial with published evidence of the effect of health behaviours on mortality risk and general population data on health behaviours , to estimate the lifetime cost-effectiveness of U@Uni in terms of incremental cost per QALY .


Costs and effects were discounted at @ % per annum .


A full probabilistic sensitivity analysis was conducted to account for uncertainty in model inputs and provide an estimate of the value of information for groups of important parameters .


To implement U@Uni for the randomised controlled trial was estimated to cost @ per participant , whereas roll-out to another university was estimated to cost @ , both giving a QALY gain of @ per participant .


The short-term ( @-month ) analysis suggested that U@Uni would not be cost-effective at a willingness-to-pay threshold of @,@ per QALY ( incremental cost per QALY gained = @,@ ) .


When a lifetime horizon was adopted the results suggest that the full implementation of U@Uni is unlikely to be cost-effective , whereas the roll-out of U@Uni to another university is extremely likely to be cost-effective .


The value of information analysis suggests that the most important drivers of decision uncertainty are uncertainties in the effect of U@Uni on health behaviours .


The study provides the first estimate of the costs and cost-effectiveness of an online health behaviour intervention targeted at new university students .


The results suggest that the roll-out , but not the full implementation , of U@Uni would be a cost-effective decision for the UK Department of Health , given a lifetime perspective and a willingness-to pay threshold of @,@ per QALY .


Depression is a widespread and serious disease often accompanied by a high degree of suffering and burden of disease .


The lack of integration between different care providers impedes guideline-based treatment .


This constitutes substantial challenges for the health care system and also causes considerable direct and indirect costs .


To face these challenges , the aim of this project is the implementation and evaluation of a guideline-based stepped care model for depressed patients with six treatment options of varying intensity and setting , including low-intensity treatments using innovative technologies .


The study is a randomized controlled intervention trial of a consecutive sample of depressive patients from primary care assessed with a prospective survey at four time-standardized measurement points within one year .


A cluster randomization at the level of participating primary care units divides the general practitioners into two groups .


In the intervention group patients ( n = @ ) are treated within the stepped care approach in a multiprofessional network consisting of general practitioners , psychotherapists , psychiatrists and inpatient care facilities , whereas patients in the control condition ( n = @ ) receive routine care .


The main research question concerns the effectiveness of the stepped-care model from baseline to t@ ( @ months ) .


Primary outcome is the change in depressive symptoms measured by the PHQ-@ ; secondary outcomes include response , remission and relapse , functional quality of life ( SF-@ and EQ-@D-@ L ) , other clinical and psychosocial variables , direct and indirect costs , and the incremental cost-effectiveness ratio .


Furthermore feasibility and acceptance of the overall model as well as of the separate treatment components are assessed .


This stepped care model integrates all primary and secondary health care providers involved in the treatment of depression ; it elaborates innovative and evidence-based treatment elements , follows a stratified approach and is implemented in routine care as opposed to standardized conditions .


In case of positive results , its sustainable implementation as a collaborative care model may significantly improve the health care situation of depressive patients as well as the interaction and care delivery of different care providers on various levels .


Evaluate aberrant drug-related behaviors in patients administering fentanyl buccal tablet or traditional short-acting opioids for breakthrough pain .


Twelve-week open-label extension .


Forty-two US sites .


Opioid-tolerant patients with chronic pain who completed the previous randomized , double-blind , crossover portion of a study comparing fentanyl buccal tablet and immediate-release oxycodone for treatment of breakthrough pain .


Patients were rerandomized to continue treatment with fentanyl buccal tablet or begin any traditional short-acting opioid .


Assessments included Screener and Opioid Assessment for Patients with Pain-Revised ( SOAPP-R ) at baseline and Addiction Behaviors Checklist and Current Opioid Misuse Measure at baseline and final visit .


Case report forms were reviewed retrospectively to identify aberrant drug-related behaviors .


One hundred thirty patients entered the open-label extension ( fentanyl buccal tablet , N = @ ; traditional short-acting opioid , N = @ ) .


SOAPP-R scores were < @ ( low risk of aberrant drug-related behavior ) in @ % of patients ; no significant differences in SOAPP-R scores were observed between treatment groups .


At the final visit , @ % of patients in each treatment group had scores indicating potential aberrant drug-related behavior ( Addiction Behaviors Checklist @ , Current Opioid Misuse Measure @ ) ; no significant differences in scores were observed between treatment groups .


Baseline SOAPP-R score @ was not predictive of Addiction Behaviors Checklist @ but was predictive of Current Opioid Misuse Measure @ .


Aberrant behaviors were identified in @ ( @ % ) fentanyl buccal tablet patients and @ ( @ % ) traditional short-acting opioid patients .


Incidence of aberrant drug-related behaviors was similar between patients taking fentanyl buccal tablet and traditional short-acting opioids over @ weeks .


To test the effectiveness of multiple interventions on increasing the response rate of text messaging for longitudinal data collection .


Our cohort included @ caregivers of children aged @-@months who were participating in an anemia program in rural China .


Using text messages to collect data on anemia medication adherence , we conducted a delayed randomized controlled trial to test multiple interventions ( an additional four reminders ; a @ ( US$ @ ) credit reward for replying ; and a feedback text message ) .


After a @-week pilot study with week @ as the baseline measurement , we randomly allocated all participants into two groups : group @ ( n = @ ) and group @ ( n = @ ) .


During weeks @-@ , we introduced the interventions to group @ , and in weeks @-@ the intervention was introduced to both groups .


We compared the response rates between groups and explored factors affecting the response rate .


During weeks @-@ , the response rates in group @ increased and were significantly higher than in group @ ( p < @ ) .


During weeks @-@ , the response rate increased significantly in group @ ( p > @ ) and slightly decreased in group @ .


Younger participants or participants who had children with lower hemoglobin concentration were more likely to reply ( p = @ ) .


Sending four reminders on the second day contributed to only @ ( @ % ) extra text messages .


Our study showed that multiple interventions were effective in increasing response rate of text messaging data collection in rural China .


Larger multi-site studies are needed to find the most effective way of using these interventions to allow usage of text messaging data collection for health research .


Lobectomy for non-small cell lung cancer ( NSCLC ) can be performed either through open thoracotomy or video-assisted thoracoscopic surgery ( VATS ) .


To improve the understanding of current attitudes of the thoracic community toward VATS lobectomy , the Collaborative Research Group conducted the Cross-sectional Survey on Lobectomy Approach ( X-SOLA ) study .


We surveyed a large cohort of lobectomy-performing thoracic surgeons to examine their adoption of VATS lobectomy and their opinions of this technique vs conventional open thoracotomy .


Participants included thoracic surgeons identified through an international index search from the Web of Science and the cardiothoracic surgery network .


A confidential questionnaire was e-mailed in June @ .


Nonresponders were given two reminder e-mails at monthly intervals .


The questionnaire , completed by @ thoracic surgeons within a @-month period , identified @ surgeons who only performed lobectomy through open thoracotomy and @ surgeons who performed VATS or robotic VATS .


Of those who performed VATS , @ % agreed with the definition of `` true '' VATS lobectomy according to the Cancer and Leukemia Group B trial .


Ninety-two percent of surgeons who did not perform VATS lobectomy responded that they were willing to learn this technique , but were hindered by limited resources , exposure , and mentoring .


Both groups agreed there was a need for VATS lobectomy training in thoracic residency programs and in standardized workshops .


X-SOLA represents the largest cross-sectional report within the thoracic community to date , demonstrating the penetration of VATS lobectomy for NSCLC internationally .


From our study , we were able to identify a number of obstacles to broaden the adoption of this minimally invasive technique .


To explore a better anesthesia method for the patients with gastric cancer who will undergo operation by investigating the impact of different anesthesia methods on stress reaction and immune function .


The present prospective study was carried out in Xiangyang Central Hospital , China , between January @ and August @ .


Sixty-four cases of antral carcinoma , subjected to radical resection of gastric cancer were randomly divided into general anesthesia group ( GA group ) and general anesthesia combined with continuous epidural anesthesia group ( GCEA group ) .


The peripheral venous bloods were sampled to determine the content of TNF - , IL-@ , IL-@ , T-lymphocyte subsets , and natural killer ( NK ) cells .


The data was analyzed by SPSS @ .


After operation , the content of TNF - , IL-@ , and IL-@ in GCEA group were significant lower than that in GA group ( p < @ ) .


At the end ofthe operation , the content of T-lymphocyte subsets and NK cells in GA and GCEA groups descended significantly , but GA group was larger ( p < @ vs. p < @ ) .


Seventy-two hours after the operation , the content of T-lymphocyte subsets and NK cells in GCEA group were back to normal , but it was significantly lower than before anesthesia ( p < @ ) in the GA group .


Compared to GA , GCEA is a better anesthesia method for gastric cancer patient who will undergo operation because it has lower stress reaction and less impact on immune function .