The study was undertaken in eight mixed-sex U.K. secondary schools , and included 3,357 school children aged 12 to 16 years ( in the two trial arms evaluated in the cost-effectiveness analysis ) .


The main outcome measures were individual self-reported data on care costs , Quality-Adjusted Life-Years ( QALYs , based on the EQ-5D health-related quality-of-life instrument ) and symptoms of depression ( Short Mood and Feelings Questionnaire ) at baseline , 6 and 12 months .


Although there was lower quality-adjusted life-years over 12 months ( -.05 QALYs per person , 95 % confidence interval -.09 to -.005 , p = .03 ) with CBT , this is a ` clinically ' negligible difference , which was not found in the complete case analyses .


There was little evidence of any between-arm differences in SMFQ scores ( 0.19 , 95 % CI -0.57 to 0.95 , p = .62 ) , or costs ( 142 , 95 % CI -132 to 415 , p = .31 ) per person for CBT versus usual school provision .


Our analysis suggests that the universal provision of classroom-based CBT is unlikely to be either more effective or less costly than usual school provision .


We investigated atorvastatin reloading effects on endothelial progenitor cell ( EPC ) count and inflammatory cytokine expression after percutaneous coronary intervention ( PCI ) in patients with stable angina pectoris who had previously received long-term statin treatments .


Patients with stable angina pectoris were treated with 80 mg atorvastatin 12 hours and 40 mg atorvastatin 2 hours before coronary angioplasty ( n = 15 ) or preoperatively with 40 mg/d atorvastatin for 7 days ( n = 15 ) or did not receive atorvastatin ( n = 15 ) .


CD45 - / 133 + / 34 + , CD45 - / CD34 + / kinase insert domain receptor ( KDR ) + , and CD45 - / CD144 + / KDR + EPCs in the peripheral blood were determined by flow cytometry 1 hour before as well as 1 hour , 6 hours , and 24 hours after PCI .


Soluble intercellular adhesion molecule 1 ( sICAM-1 ) , hypersensitive C-reactive protein ( hCRP ) , and troponin-I ( TnI ) serum concentrations were analyzed immediately prior to and 24 hours after PCI .


In the 40mg Atorvastatin and control groups , none of the analyzed EPC blood concentrations changed significantly from 1h before operation to 1h and 6 h postoperative values .


In contrast , the number of circulating early differentiation stage EPCs CD45 - / 133 + / 34 + and CD45 - / CD34 + / KDR + raised significantly from 1 h preoperative values ( 57.39.3 ; 57.3 10.7 ) to 1 h postoperative ( ( 74.4 11.4 ; 78.8 16.2 ) , ( p < 0.05 ) ) and 6 h postoperative ( ( 93 16.9 ; 99.7 11.9 ) , ( p < 0.05 ) ) concentrations after coronary angioplasty in the 80mg Atorvastatin medication patients .


In the control group , the sICAM-1 ( 174.55 38.91 vs 204.11 58.24 ) and hCRP ( 1.89 1.93 vs 9.0 11.1 ) serum concentrations at 24 hours after PCI were significantly elevated ( P < .05 ) compared to preoperative values , whereas the increases in the 2 groups treated with atorvastatin were not significant .


In addition , the rise in serum TnI concentration level from pre - to postoperative in the 80-mg ( 0.02 0.02 vs 0.09 0.08 ) and the 40-mg ( 0.01 0.03 vs 1.2 2.59 ) reloading groups was less than that of the controls ( 0.01 0.02 vs 1.75 3.09 ) ( p < 0.05 ) .


Our results suggested that high-dose atorvastatin application before PCI triggered early EPC circulation .


Furthermore , postoperative inflammatory cytokine sICAM-1 as well as hCRP serum levels were reduced , while postinterventional myocardial injury marker TnI elevations were inversely correlated with statin reloadings .


Airway inflammation , mediated in part by LTB4 , contributes to lung destruction in patients with cystic fibrosis ( CF ) .


LTB ( 4 ) - receptor inhibition may reduce airway inflammation .


We report the results of a randomized , double-blind , placebo-controlled study of the efficacy and safety of the leukotriene B ( 4 ) ( LTB ( 4 ) ) - receptor antagonist BIIL 284 BS in CF patients .


CF patients aged 6 years with mild to moderate lung disease were randomized to oral BIIL 284 BS or placebo once daily for 24 weeks .


Co-primary endpoints were change in FEV ( 1 ) and incidence of pulmonary exacerbation .


After 420 ( 155 children , 265 adults ) of the planned 600 patients were randomized , the trial was terminated after a planned interim analysis revealed a significant increase in pulmonary related serious adverse events ( SAEs ) in adults receiving BIIL 284 BS .


Final analysis revealed SAEs in 36.1 % of adults receiving BIIL 284 BS vs. 21.2 % receiving placebo ( p = 0.007 ) , and in 29.6 % of children receiving BIIL 284 BS vs. 22.9 % receiving placebo ( p = 0.348 ) .


In adults , the incidence of protocol-defined pulmonary exacerbation was greater in those receiving BIIL 284 BS than in those receiving placebo ( 33.1 % vs. 18.2 % respectively ; p = 0.005 ) .


In children , the incidence of protocol-defined pulmonary exacerbation was 19.8 % in the BIIL 284 BS arm , and 25.7 % in the placebo arm ( p = 0.38 ) .


While the cause of increased SAEs and exacerbations due to BIIL 284 BS is unknown , the outcome of this trial provides a cautionary tale for the administration of potent anti-inflammatory compounds to individuals with chronic infections , as the potential to significantly suppress the inflammatory response may increase the risk of infection-related adverse events .


Alopecia areata is an idiopathic cause of hair loss with limited therapeutic repertoire .


To compare the efficacy and safety of a high - vs low-potency topical corticosteroid in pediatric patients .


This single-center , randomized , blind , 2-arm , parallel-group , superiority trial was carried out over a 24-week period at a tertiary referral academic dermatology clinic at The Hospital for Sick Children in Toronto , Ontario , Canada .


Forty-two children attending the outpatients clinic , 2 to 16 years of age with alopecia areata affecting at least 10 % of scalp surface area , were eligible ; 1 declined to participate .


There were no withdrawals from the study .


INTERVENTIONS FOR CLINICAL TRIALS : Patients were randomly assigned to receive clobetasol propionate , 0.05 % cream , or hydrocortisone , 1 % , cream .


Patients applied a thin layer of the assigned cream twice daily to the areas of hair loss for 2 cycles of 6 weeks on , 6 weeks off , for a total of 24 weeks .


The primary outcome was the change in scalp surface area with hair loss over 24 weeks following enrollment .


RESULTS All participants were assessed at 6 , 12 , 18 , and 24 weeks ( except 1 participant who missed the 6-week visit ) .


After adjusting for baseline hair loss , the clobetasol group had a statistically significant ( P < .001 ) greater decrease in the surface area with hair loss , compared with the hydrocortisone group at all time points except at 6 weeks .


One patient with extensive alopecia areata experienced skin atrophy that resolved spontaneously in 6 weeks .


There was no difference observed in the number of patients with abnormal urinary cortisol at the beginning and the end of the study .


Topical clobetasol propionate , 0.05 % , cream is efficacious and safe as a first-line agent for limited patchy childhood alopecia areata .


TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT01453686 .


Given the limited sensitivity and specificity of prostate-specific antigen ( PSA ) , its widespread use as a screening tool has raised concerns for the overdiagnosis of low-risk and the underdiagnosis of high-grade prostate cancer .


To improve early-detection biopsy decisions , the National Cancer Institute conducted a prospective validation trial to assess the diagnostic performance of the prostate cancer antigen 3 ( PCA3 ) urinary assay for the detection of prostate cancer among men screened with PSA .


In all , 859 men ( mean age , 62 years ) from 11 centers scheduled for a diagnostic prostate biopsy between December 2009 and June 2011 were enrolled .


The primary outcomes were to assess whether PCA3 could improve the positive predictive value ( PPV ) for an initial biopsy ( at a score > 60 ) and the negative predictive value ( NPV ) for a repeat biopsy ( at a score < 20 ) .


For the detection of any cancer , PPV was 80 % ( 95 % CI , 72 % to 86 % ) in the initial biopsy group , and NPV was 88 % ( 95 % CI , 81 % to 93 % ) in the repeat biopsy group .


The addition of PCA3 to individual risk estimation models ( which included age , race/ethnicity , prior biopsy , PSA , and digital rectal examination ) improved the stratification of cancer and of high-grade cancer .


These data independently support the role of PCA3 in reducing the burden of prostate biopsies among men undergoing a repeat prostate biopsy .


For biopsy-naive patients , a high PCA3 score ( > 60 ) significantly increases the probability that an initial prostate biopsy will identify cancer .


Early laryngeal cancer is usually treated with either transoral laser surgery or radiation therapy .


The quality of voice achieved with these treatments has not been compared in a randomized trial .


Male patients with carcinoma limited to 1 mobile vocal cord ( T1aN0M0 ) were randomly assigned to receive either laser surgery ( n = 32 ) or external beam radiation therapy ( n = 28 ) .


Surgery consisted of tumor excision with a CO2 laser with the patient under general anaesthesia .


External beam radiation therapy to the larynx was delivered to a cumulative dose of 66 Gy in 2-Gy daily fractions over 6.5 weeks .


Voice quality was assessed at baseline and 6 and 24 months after treatment .


The main outcome measures were expert-rated voice quality on a grade , roughness , breathiness , asthenia , and strain ( GRBAS ) scale , videolaryngostroboscopic findings , and the patients ' self-rated voice quality and its impact on activities of daily living .


Overall voice quality between the groups was rated similar , but voice was more breathy and the glottal gap was wider in patients treated with laser surgery than in those who received radiation therapy .


Patients treated with radiation therapy reported less hoarseness-related inconvenience in daily living 2 years after treatment .


Three patients in each group had local cancer recurrence within 2 years from randomization .


Radiation therapy may be the treatment of choice for patients whose requirements for voice quality are demanding .


Overall voice quality was similar in both treatment groups , however , indicating a need for careful consideration of patient-related factors in the choice of a treatment option .


The current study was conducted to find out whether two oral preparations of 300 mg gabapentin ( the test and reference capsules ) were bioequivalent .


This was a randomized , single-blind , crossover study under fasting condition , with a 7-day washout period , which included 37 healthy adult male and female subjects .


After an overnight fast , subjects were given , orally , one capsule of the test drug or of the reference drug .


Blood samples were drawn immediately before taking the drug , then at 20 and 40 minutes , and 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 10 , 12 , 15 , and 24 hours after dosing , to evaluate pharmacokinetic parameters of the single dose administration , ie , the area under the plasma concentration-time curve ( AUC ) from time zero to 24 hours ( AUCt ) , AUC from time zero to infinity ( AUC ( inf ) ) , the peak plasma concentration of the drug ( Cmax ) , time needed to achieve Cmax ( tmax ) , and the elimination half-life ( t1/2 ) .


The plasma concentrations of gabapentin were determined using validated high-performance liquid chromatography with ultraviolet detection .


The geometric mean ratios ( 90 % confidence interval ) of the test drug/reference drug for gabapentin were 103.15 % ( 90.38 % -117.72 % ) for AUCt , 103.53 % ( 90.78 % -118.07 % ) for AUC ( inf ) , and 108.06 % ( 96.32 % -121.24 % ) for Cmax .


The differences in tmax and t1/2 values between the test and reference drug products for gabapentin were not statistically significant .


Light-headedness , nausea , and headache were encountered during the study , but they were all mild and well tolerated .


The 90 % confidence intervals of the test/reference AUC ratio and Cmax ratio of gabapentin were within the acceptance range for bioequivalence .


The two preparations of gabapentin 300 mg capsule were bioequivalent , thus both can be used interchangeably in the clinical setting .


We investigated the effects of 2-year folic acid and vitamin B12 supplementation on cognitive performance in elderly people with elevated homocysteine ( Hcy ) levels .


This multicenter , double-blind , randomized , placebo-controlled trial included 2,919 elderly participants ( 65 years and older ) with Hcy levels between 12 and 50 mol/L .


Participants received daily either a tablet with 400 g folic acid and 500 g vitamin B12 ( B-vitamin group ) or a placebo tablet .


Both tablets contained 15 g vitamin D3 .


Data were available for global cognitive functioning assessed by Mini-Mental State Examination ( n = 2,556 ) , episodic memory ( n = 2,467 ) , attention and working memory ( n = 759 ) , information processing speed ( n = 731 ) , and executive function ( n = 721 ) .


Mean age was 74.1 ( SD 6.5 ) years .


Hcy concentrations decreased 5.0 ( 95 % confidence interval -5.3 to -4.7 ) mol/L in the B-vitamin group and 1.3 ( -1.6 to -0.9 ) mol/L in the placebo group .


Cognitive domain scores did not differ over time between the 2 groups , as determined by analysis of covariance .


Mini-Mental State Examination score decreased with 0.1 ( -0.2 to 0.0 ) in the B-vitamin group and 0.3 ( -0.4 to -0.2 ) in the placebo group ( p = 0.05 ) , as determined by an independent t test .


Two-year folic acid and vitamin B12 supplementation did not beneficially affect performance on 4 cognitive domains in elderly people with elevated Hcy levels .


It may slightly slow the rate of decline of global cognition , but the reported small difference may be attributable to chance .


This study provides Class I evidence that 2-year supplementation with folic acid and vitamin B12 in hyperhomocysteinemic elderly people does not affect cognitive performance .


Fluticasone furoate/vilanterol ( FF/VI ) is an inhaled corticosteroid/long-acting beta2-agonist ( ICS/LABA ) , recently approved as once-daily maintenance therapy for COPD .


We compared the lung function effects of FF/VI with those of twice-daily fluticasone propionate/salmeterol ( FP/SAL ) .


Three 12 week studies comparing FF/VI and FP/SAL were conducted .


Patients aged 40 years with moderate-to-very severe COPD were randomized to receive double-blind , double-dummy FF/VI 100/25 mcg once-daily , or FP/SAL 250/50 mcg twice-daily for 12 weeks following a 2 week placebo run-in period .


The primary endpoint of each study was change from baseline trough in 0-24 h weighted mean FEV ( 1 ) ( wmFEV ( 1 ) ) on Day 84 .


Safety was also assessed .


In Study 1 ( HZC113109 ) ( intent-to-treat n : FF/VI = 260 ; FP/SAL = 259 ) , the increase from baseline in 0-24 h wmFEV ( 1 ) was significantly greater with FF/VI than FP/SAL ( 80 mL , P < 0.001 ) .


In Study 2 ( HZC112352 ) ( intent-to-treat n : FF/VI = 259 ; FP/SAL = 252 ) and Study 3 ( RLV116974 ) ( intent-to-treat n : FF/VI = 412 ; FP/SAL = 416 ) , the increase from baseline in 0-24 h wmFEV ( 1 ) was not significantly greater with FF/VI than FP/SAL ( 29 mL , P = 0.267 ; 25 mL , P = 0.137 ) .


The treatment difference was statistically but not clinically significant in a pooled analysis ( 41 mL , P < 0.001 ) .


Pooled adverse events ( FF/VI 27 % ; FP/SAL 28 % ) and serious adverse events ( FF/VI 2 % ; FP/SAL 3 % ) were similar between treatments .


Our data suggest that once-daily FF/VI 100/25 mcg provides FEV ( 1 ) improvement in COPD that is at least comparable with that conferred by twice-daily FP/SAL 250/50 mcg , although interpretation is limited by differences in individual study outcomes .


The safety profiles of FF/VI 100/25 mcg and FP/SAL 250/50 mcg are similar .


clinicaltrials.gov : NCT01323634 ; NCT01323621 ; NCT01706328 .


GlaxoSmithKline study codes : HZC113109 ; HZC112352 ; RLV116974 .


Atrial fibrillation ( AF ) is common in dialysis patients and is associated with increased morbidity and mortality .


The pathophysiology may be related to common risk factors for both AF and renal disease or to dialysis-specific factors .


The purpose of this study was to determine whether and how AF onset relates to the dialysis procedure itself .


All dialysis patients enrolled in the implantable cardioverter defibrillator-2 ( ICD-2 ) trial until January 2012 , who were implanted with an ICD , were included in this study .


Using the ICD remote monitoring function , the exact time of onset of all AF episodes was registered .


Subsequently , this was linked to the timing of dialysis procedures .


For the current study , a total of 40 patients were included , follow-up was 28 16 months , 80 % male , 70 8 years old .


A total of 428 episodes of AF were monitored in 14 patients .


AF onset was more frequent on the days of haemodialysis ( HD ) ( p < 0.001 ) and specifically increased during the dialysis procedure itself ( p = 0.04 ) .


Patients with AF had a larger left atrium ( p < 0.001 ) and a higher systolic blood pressure before and after HD ( p < 0.001 ) .


This study provides insight in the exact timing of AF onset in relation to the dialysis procedure itself .


In HD patients , AF occurred significantly more often on a dialysis day and especially during HD .


These findings might help to elucidate some aspects of the pathophysiology of AF in dialysis patients and could facilitate early detection of AF in these high-risk patients .


Low dose computerised tomography ( CT ) screening for lung cancer can reduce lung-cancer-specific mortality .


The objective of this study was to analyse healthcare costs and healthcare utilisation of participants in the Danish lung cancer CT-screening trial ( DLCST ) .


This registry study was nested in a randomised controlled trial ( DLCST ) .


4104 participants , current or former heavy smokers , aged 50-70 years were randomised to five annual low dose CT scans or usual care during 2004-2010 .


Total healthcare costs and healthcare utilisation data for both the primary and the secondary healthcare sector were retrieved from public registries from randomisation - September 2011 and compared between ( 1 ) the CT-screening group and the control group and , ( 2 ) the control group and each of the true-positive , false-positive and true-negative groups .


The median annual costs per participant were significantly higher in the CT-screening group ( Euros [ EUR ] 1342 , interquartile range [ IQR ] 750-2980 ) compared with the control group ( EUR 1190 , IQR 590-2692 ) ( p < 0.0001 ) .


When the cost of the CT-screening programme was excluded , there was no longer a statistically significant difference between the CT-screening group ( EUR 1155 , IQR 567-2798 ) and the control group ( p = 0.52 ) .


Analyses according to the diagnostic groups showed that annual costs were 10.57 ( 95 % CI 7.09-15 .75 ) times higher for the true-positive and 1.67 ( 95 % CI 1.20-2 .32 ) times higher for the false-positive group compared with the control group .


Low dose lung cancer CT screening increases healthcare costs compared with no screening ; this difference was attributable to the costs of the CT-screening programme .


Overall healthcare costs were higher for the true-positive and false-positive groups than for the control group , also when excluding the cost of the CT-screening programme .


This increase was outweighed by the larger true-negative group showing no significant differences in costs compared with the control group .


The purpose of this study was to investigate whether individualized deliberate practice on a virtual reality ( VR ) simulator results in improved technical performance in the operating room .


Training on VR simulators has been shown to improve technical performance in the operating room ( OR ) .


Currently described VR curricula consist of trainees practicing the same tasks until expert proficiency is reached .


It has yet to be investigated whether the individualized deliberate practice , where curricula tasks vary depending on prior levels of technical proficiency , would translate into the OR .


This single-blinded prospective trial randomized 16 novice surgical residents to a deliberate practice ( DP ) group and a conventional residency training group .


Both groups performed a laparoscopic cholecystectomy in the OR that was video-recorded .


Technical performance of DP group residents in the OR was assessed using 3 validated assessment tools .


A score of less than 60 % on any component of the assessment tool resulted in the trainee practicing a specific task on the VR simulator .


The DP group practiced on the simulator as per their individualized schedule .


Both groups then performed another laparoscopic cholecystectomy .


A blinded expert assessed the OR recordings using a validated global rating scale .


Although both groups had similar technical abilities preintervention [ DP : median score , 13.5 ( 9.3-15 .0 ) ; control : median score , 14.5 ( 9.3-17 .8 ) ; P = 0.45 ] , the DP residents had a superior technical performance postintervention [ DP : median score , 17.0 ( 15.3-18 .5 ) ; control : median score , 12.5 ( 7.5-14 .0 ) ; P = 0.03 ] .


Of 8 DP residents , 6 practiced 5 basic VR tasks ( median 1 trial to pass ) , and 7 of 8 practiced 2 advanced tasks ( median 4 trials to pass ) .


A curriculum of deliberate individualized practice on a VR simulator improves technical performance in the OR .


This has implications to greatly improve the feasibility of implementing simulation-based curricula in residency training programs , rather then having them being limited to research protocols .


A 16-week lunchtime walking intervention was designed to increase physical activity in physically inactive University employees .


The program was delivered and monitored twice over 7 months to examine feasibility across different seasons .


Seventy-five participants ( n = 69 females , n = 6 males ; mean age = 47.68 ) were randomly allocated into a Winter ( February start ) or Spring group ( May start ) .


Participants were asked to complete 3 weekday lunchtime walks and 2 weekend walks .


Weeks 1 to 10 were led by walk leaders ( group phase ) while the participants self-organized their walks during weeks 11 to 16 ( independent phase ) .


Yamax pedometers recorded daily step counts and walk group leaders recorded participant attendance in the group phase .


Acceptability was assessed via a satisfaction survey and 2 focus groups with participants .


A participant pool representative by ethnicity , but not gender was recruited using a range of strategies .


The program demonstrated good retention across both groups ( 73 % ) .


The intervention was acceptable to participants .


More steps were accumulated in the group-led versus the independent phase .


The intervention is feasible in this workplace setting across different seasonal periods .


In the future , researchers should examine if the findings can be replicated in a definitive trial and generalize to other workplace settings .


Ramosetron , a serotonin ( 5-hydroxytryptamine ) -3 receptor antagonist with high selectivity , reduced stress-induced diarrhea and defecation caused by corticotropin-releasing hormone in rats .


However , there have been no clinical trials of its effect in patients with diarrhea and irritable bowel syndrome ( IBS-D ) .


We performed a randomized , double-blind , placebo-controlled trial to determine whether ramosetron reduces diarrhea in these patients .


Our study included 296 male outpatients with IBS-D treated at 52 centers in Japan .


Patients were given 5 g oral ramosetron ( n = 147 ) or placebo ( n = 149 ) once daily for 12 weeks after a 1-week baseline period .


The primary end point was increased stool consistency in the first month .


Secondary end points included relief of overall IBS symptoms and increased IBS-related quality of life .


More patients given ramosetron ( 74 , 50.3 % ) than those given placebo ( 29 , 19.6 % ) reported improved stool consistency in the first month ( P < .001 ) .


The relative risk and number needed to treat were 2.57 ( 95 % confidence interval , 1.79-3 .70 ) and 3.25 ( 95 % confidence interval , 2.44-4 .89 ) , respectively .


The ramosetron group had significantly higher monthly rates of relief of overall IBS symptoms and IBS-related quality of life than the placebo group .


Ramosetron ( 5 g oral , once daily for 12 weeks ) improved stool consistency in male patients with IBS-D , compared with placebo .


These study results , along with the pharmacologic profile of ramosetron , indicate that increased stool consistency is the best end point for studies of ramosetron in patients with IBS-D .


Clinicaltrials.gov No , NCT01225237 .


Formoterol fumarate ( FF ) is a well-established long-acting 2-agonist .


This represents the first clinical study of FF in a metered-dose inhaler ( FF MDI ) based on proprietary lipid-based porous-particle engineering technology .


In this randomized , double-blind , 5-period , crossover study ( NCT00880490 ) , subjects received 2.4 , 4.8 , and 9.6 g of FF MDI , open-label Foradil ( ) Aerolizer ( ) ( FA ) 12g , and placebo .


Spirometry was performed at baseline , 15 and 30min , and 1 , 2 , 4 , 6 , 8 , 10 , 11.5 , and 12h post-dose .


Thirty-four subjects were enrolled .


Improvement in forced expiratory volume in 1s ( FEV1 ) was similar between FF MDI 9.6 g and FA .


Change in FEV1 area under the curve for 0-12h ( AUC0-12 ) for each FF MDI dose demonstrated superior efficacy versus placebo ( P < .001 for all 3 doses ) .


Over 12h and at each time point , FF MDI 9.6 g was non-inferior to FA for FEV1 AUC0-12 with the 95 % CI 's supporting a maximum difference of approximately 45mL .


Peak and trough FEV1 , forced vital capacity , peak expiratory flow rate , peak inspiratory capacity , and pharmacokinetics confirmed the primary endpoint , with dose ordering of the FF MDI 2.4 , 4.8 , and 9.6 g , and comparability of FF MDI 9.6 g to FA .


All 3 doses of FF MDI were safe and well-tolerated , with a safety profile similar to that of placebo and FA .


The efficacy and pharmacokinetic profile of FF MDI 9.6 g were comparable to FA 12g and with similar safety to placebo and FA .


This clinical trial was registered on ClinicalTrials.gov , Identifier : NCT NCT00880490 .


Fatigue is a common problem among multiple myeloma ( MM ) patients .


Armodafinil is a drug known to promote wakefulness , which is related to modafinil , a compound that improves fatigue in some cancer patients treated with chemotherapeutic agents .


We investigated whether armodafinil could reduce cancer-related fatigue in MM patients .


This double-blind , placebo-controlled phase 3 trial evaluated the efficacy of armodafinil in MM patients with evidence of moderate fatigue .


Patients were randomized to one of two arms : treatment-only , with armodafinil given at 150 mg/daily for 56 days , or placebo-first , with placebo given on days 1-28 , followed by armodafinil administered at 150 mg daily on days 29-56 .


Fatigue was measured on days 1 ( pre-dose : baseline ) , 15 , 28 , 43 , and 56 using seven separate assessments , including four patient-reported outcomes of fatigue and related quality of life measures , as well as three objective measures of cognitive function .


Overall toxicities were similar between treatment groups .


No significant differences were observed between the placebo-first and the treatment-only arms after 28 days .


Treatment with armodafinil for 28 additional days did not produce responses .


Both placebo-first and treatment-only patients showed similar significant improvements in three patient-reported measures and one objective task at day 28 compared to baseline .


Placebo-first patients improved on eight additional measures ( one patient-reported measure , six subscales , and one objective task ) , suggesting a strong placebo effect in this patient population .


Evaluation and treatment of cancer-related fatigue continues to be challenging ; a clear definition of this symptom and better assessment tools are needed .


Opportunistic brief in-person emergency department ( ED ) interventions can be effective at reducing hazardous alcohol use in young adult drinkers , but require resources frequently unavailable .


Mobile telephone text messaging ( short message service [ SMS ] ) could sustainably deliver behavioral support to young adult patients , but efficacy remains unknown .


We report 3-month outcome data of a randomized controlled trial testing a novel SMS-delivered intervention in hazardous-drinking young adults .


We randomized 765 young adult ED patients who screened positive for past hazardous alcohol use to one of 3 groups : SMS assessments + feedback ( SA+F ) intervention who were asked to respond to drinking-related queries and received real-time feedback through SMS each Thursday and Sunday for 12 weeks ( n = 384 ) , SMS assessments ( SA ) who were asked to respond to alcohol consumption queries each Sunday but did not receive any feedback ( N = 196 ) , and a control group who did not participate in any SMS ( n = 185 ) .


Primary outcomes were self-reported number of binge drinking days and number of drinks per drinking day in the past 30 days , collected by Web-based timeline follow-back method and analyzed with regression models .


Secondary outcomes were the proportion of participants with weekend binge episodes and most drinks consumed per drinking occasion during 12 weekends , collected by SMS .


With Web-based data , there were decreases in the number of self-reported binge drinking days from baseline to 3 months in the SA+F group ( -0.51 [ 95 % confidence interval { CI } -0.10 to -0.95 ] ) , whereas there were increases in the SA group ( 0.90 [ 95 % CI 0.23 to 1.6 ] ) and the control group ( 0.41 [ 95 % CI -0.20 to 1.0 ] ) .


There were also decreases in the number of self-reported drinks per drinking day from baseline to 3 months in the SA+F group ( -0.31 [ 95 % CI -0.07 to -0.55 ] ) , whereas there were increases in the SA group ( 0.10 [ 95 % CI -0.27 to 0.47 ] ) and the control group ( 0.39 [ 95 % CI 0.06 to 0.72 ] ) .


With SMS data , there was a lower mean proportion of SA+F participants reporting a weekend binge during 12 weeks ( 30.5 % [ 95 % CI 25 % to 36 % ) compared with the SA participants ( 47.7 % [ 95 % CI 40 % to 56 % ] ) .


There was also a lower mean drinks consumed per weekend during 12 weeks in the SA+F group ( 3.2 [ 95 % CI 2.6 to 3.7 ] ) compared to the SA group ( 4.8 [ 95 % CI 4.0 to 5.6 ] ) .


A text message intervention can produce small reductions in self-reported binge drinking and the number of drinks consumed per drinking day in hazardous-drinking young adults after ED discharge .


To investigate the efficacy of a proactive feeding regimen ( PFR ) in reducing hospital length of stay in a population of moderately preterm small for gestational age ( SGA ) infants .


SGA infants ( z-score < -1.28 ) of gestational age ( GA ) 32-36 weeks and birth weight ( BW ) > 1499 g were allocated at random to receive either a PFR , starting with 100 mL/kg/day and gradually increasing to 200 mL/kg/day by day 4 , or a standard feeding regimen , starting with 60 mL/kg/day and gradually increasing to 170 mL/kg/day by day 9 .


All infants received human milk .


A total of 72 infants were randomized to the 2 groups , 36 to the PFR group ( mean GA , 35.1 0.7 weeks ; mean BW , 1761 177 g ) and 36 to the standard feeding regimen group ( mean GA , 35.5 1.2 weeks ; mean BW , 1754 212 g ) .


Infants in the PFR group were discharged significantly earlier ( mean , 9.8 3.1 days vs 11.9 4.7 days ; P = .029 ) .


The need for intravenous fluids ( 2.8 % vs 33.3 % ; P = .0013 ) and the incidence of hypoglycemia ( 0 vs 33.3 % ; P = .00016 ) were significantly lower in the PFR group .


Feeding intolerance and fecal calprotectin levels did not differ between the 2 groups .


A PFR in moderately preterm SGA infants is well tolerated and significantly reduces both the length of stay and the risk of neonatal hypoglycemia .


The study aimed to confirm the efficacy , through non-inferiority , of patient-driven versus investigator-driven titration of biphasic insulin aspart 30 ( BIAsp 30 ) in terms of glycemic control assessed by HbA1c change .


SimpleMix was a 20 week , open-label , randomized , two-armed , parallel-group , multicenter study in five countries ( Argentina , China , India , Poland , and the UK ) .


Patients with type 2 diabetes were randomized into either patient-driven or investigator-driven BIAsp 30 titration groups .


Non-inferiority of patient-driven vs. investigator-driven titration based on change in HbA1c from baseline to week 20 could not be demonstrated .


Mean ( SE ) estimated change from baseline to week 20 was -0.72 ( 0.08 ) % in the patient-driven group and -0.97 ( 0.08 ) % in the investigator-driven group ; estimated difference 0.25 % ( 95 % CI : 0.04 ; 0.46 ) .


Estimated mean change ( SE ) in fasting plasma glucose from baseline to week 20 was similar between groups : -0.94 ( 0.21 ) mmol/L for patient-driven and -1.07 ( 0.22 ) mmol/L for investigator-driven ( difference non-significant ) .


Both treatment arms were well tolerated , and hypoglycemic episode rates were similar between groups , with a rate ratio of 0.77 ( 95 % CI : 0.54 ; 1.09 ; p = 0.143 ) for all hypoglycemic episodes and 0.78 ( 95 % CI : 0.42 ; 1.43 ; p = 0.417 ) for nocturnal hypoglycemic episodes .


Non-inferiority of patient-driven versus investigator-driven titration with regard to change from baseline to end-of-treatment HbA1c could not be confirmed .


It is possible that a clinic visit 12 weeks after intensification of treatment with BIAsp 30 in patients with type 2 diabetes inadequately treated with basal insulin may benefit patient-driven titration of BIAsp 30 .


A limitation of the study was the relatively small number of patients recruited in each country , which does not allow country-specific analyses to be performed .


Overall , treatment with BIAsp 30 was well tolerated in both treatment groups .


Daylight-mediated photodynamic therapy ( DL-PDT ) using methyl-5-aminolaevulinate ( MAL ) is effective for thin , grade I , actinic keratoses ( AK ) .


There are no published studies of other photosensitizers used in DL-PDT .


To compare the efficacy and adverse effects of 5-aminolaevulinic acid nanoemulsion ( BF-200 ALA ) with MAL in DL-PDT of grade I-III AKs .


In 13 patients , 177 AKs were randomized symmetrically for a split-face prospective observer-blinded study and received either BF-200 ALA or MAL DL-PDT .


Grade I AKs were treated once and grade II-III AKs twice with a 025-mm layer of photosensitizer precursors .


Pain was assessed during and after the daylight exposure .


Efficacy at 3months was assessed clinically and histologically .


BF-200 ALA cleared 71/84 ( 845 % ) and MAL 69/93 ( 742 % ) of the AKs ( P = 0099 ) , all grades responding equally , but with new AKs appearing during follow-up ( n = 4 , BF-200 ALA ; n = 8 , MAL ) .


In per patient half-face analysis BF-200 ALA showed significantly higher clearance rates for grade I AKs than did MAL ( P = 0027 ) , but for thicker grades , clearance was equal ( P = 0564 ) .


BF-200 ALA and MAL treatments resulted in 615 % and 385 % complete histological clearance ( P = 0375 ) , respectively .


p53 expression decreased by 544 % and 337 % , respectively ( P = 0552 ) .


Both treatments were nearly painless with similar adverse reactions and no difference in patient preference .


BF-200 ALA showed a trend towards improved efficacy results compared with MAL .


Thicker lesions in both groups responded when treated repeatedly .


Importantly , a thin 025-mm layer of the photosensitizer precursors was sufficient , which may lead to lower expense .


DTaP5-IPV-Hib-HepB is a fully liquid investigational hexavalent vaccine directed against 6 diseases .


This multicenter , open-label , comparator-controlled , phase III study randomly assigned healthy infants 2-to-1 as follows : group 1 received DTaP5-IPV-Hib-HepB , PCV13 , and RV5 at 2 , 4 , and 6 months of age followed by DTaP5 , Hib-OMP , and PCV13 at 15 months of age ; group 2 received DTaP5-IPV/Hib , PCV13 , and RV5 at 2 , 4 , and 6 months of age , with HepB at 2 and 6 months of age , followed by DTaP5 , Hib-TT , and PCV13 at 15 months of age .


Overall , 981 participants were vaccinated in group 1 and 484 in group 2 .


Immune responses in group 1 to all antigens contained in DTaP5-IPV-Hib-HepB 1 month after dose 3 and for concomitant rotavirus vaccine were noninferior to those in group 2 , with the exception of antipertussis filamentous hemagglutinin ( FHA ) geometric mean concentrations ( GMCs ) .


Vaccine response rates for FHA were noninferior to control .


After the toddler dose , group 1 immune responses were noninferior to group 2 for all pertussis antigens .


Solicited adverse event rates after any dose were similar in both groups , with the exceptions of increased injection-site erythema , increased fever , and decreased appetite in group 1 .


Fever was not associated with hospitalization or seizures .


The safety and immunogenicity of DTaP5-IPV-Hib-HepB are comparable with the analogous licensed component vaccines .


Decreased FHA GMCs and increased injection-site reactions and fever are unlikely to be clinically significant .


DTaP5-IPV-Hib-HepB provides a new combination vaccine option aligned with the recommended US infant immunization schedule .


In rural South Africa , only two-thirds of HIV-positive pregnant women seeking antenatal care at community health centers took full advantage of ` prevention of mother-to-child transmission ' ( PMTCT ) services in 2010 .


Studies generally support male involvement to promote PMTCT , but the nature and impact of that involvement is unclear and untested .


Additionally , stigma , disclosure and intimate partner violence pose significant barriers to PMTCT uptake and retention in care , suggesting that male involvement may be ` necessary , but not sufficient ' to reduce infant HIV incidence .


This study expands on a successful United States President 's Emergency Plan for AIDS Relief ( PEPFAR ) - supported PMTCT couples intervention pilot study conducted in the Mpumalanga province , targeting HIV-positive pregnant women and their partners , the primary objective being to determine whether male partner involvement plus a behavioral intervention will significantly reduce infant HIV incidence .


The study follows a cluster randomized controlled design enrolling two cohorts of HIV-positive pregnant women recruited from 12 randomly assigned Community Health Centers ( CHC ) ( six experimental , six control ) .


The two cohorts will consist of women attending without their male partners ( n = 720 ) and women attending with their male partners ( n = 720 couples ) , in order to determine whether the influence of male participation itself , or combined with a behavioral PMTCT intervention , can significantly reduce infant HIV infection ante - , peri - and postnatally .


It is our intention to significantly increase PMTCT participation from current levels ( 69 % ) in the Mpumalanga province to between 90 and 95 % through engaging women and couples in a controlled , six session ante - and postnatal risk-reducing and PMTCT promotion intervention addressing barriers to PMTCT ( such as stigma , disclosure , intimate partner violence , communication , infant feeding practices and safer conception ) that prevent women and men from utilizing treatment opportunities available to them and their infants .


Based upon the encouraging preliminary results from our pilot study , successful CHC adoption of the program could have major public health policy implications for containing the epidemic among the most vulnerable populations in rural South Africa : HIV-positive pregnant women and their infants .


ClinicalTrials.gov NCT02085356 ( registration date : 10 March 2014 ) .


The aim of this study was to evaluate the analgesic efficacy and safety of rectus sheath block combined with intraperitoneal instillation using two doses of ropivacaine in patients undergoing laparoscopic gynecological surgery .


Altogether 53 consenting women were randomized to receive intraperitoneal infiltration with 0.25 % ropivacaine or 0.5 % ropivacaine followed by rectus sheath block with 0.375 % ropivacaine .


The outcomes of clinical safety were measured using plasma concentration of local anesthetics and occurrence of toxic symptoms .


The analgesic efficacy was assessed using numerical rating scales for pain and morphine consumption up to 24 hours after surgery .


Patients ' baseline characteristics , surgical factors , and analgesic outcomes were comparable between the two groups .


Although peak plasma concentration of ropivacaine was significantly higher in patients receiving 0.5 % ropivacaine , none of analyzed concentrations was above the toxic ones .


Besides , no patients showed any symptoms of local anesthetic toxicity .


The present study showed that the combination of rectus sheath block with intraperitoneal instillation of ropivacaine was safe and potent enough to relieve pain after laparoscopic surgery .


Despite growing interest in the importance of , and challenges associated with the involvement of patient and population ( IPP ) in the process of developing and adapting clinical practice guidelines ( CPGs ) , there is a lack of knowledge about the best method to use .


This is especially problematic in the field of rehabilitation , where individuals with disabilities might face many barriers to their involvement in the guideline development and adaptation process .


The goal of this pilot trial is to document the acceptability , feasibility and effectiveness of two methods of involving patients with a disability ( traumatic brain injury ) in CPG development .


A single-blind , randomized , crossover pragmatic trial will be performed with 20 patients with traumatic brain injury ( TBI ) .


They will be randomized into two groups , and each will try two alternative methods of producing recommendations ; a discussion group ( control intervention ) and a Wiki , a webpage that can be modified by those who have access to it ( experimental intervention ) .


The participants will rate the acceptability of the two methods , and feasibility will be assessed using indicators such as the number of participants who accessed and completed the two methods , and the number of support interventions required .


Twenty experts , blinded to the method of producing the recommendations , will independently rate the recommendations produced by the participants for clarity , accuracy , appropriateness and usefulness .


Our trial will allow for the use of optimal IPP methods in a larger project of adapting guidelines for the rehabilitation of individuals with TBI .


Ultimately the results will inform the science of CPG development and contribute to the growing knowledge about IPP in rehabilitation settings .


Clinical trial KT Canada 87776 .


Evidence is often missing on social differentials in effects of nutrition interventions .


We evaluated the adherence to and effect of prenatal food and micronutrient supplementations on mortality before the age of five years in different social groups as defined by maternal schooling .


Data came from the MINIMat study ( Maternal and Infant Nutrition Interventions , Matlab ) , a randomized trial of prenatal food supplementation ( invitation early , about 9 weeks [ E ] , or at usual time , about 20 weeks [ U ] of pregnancy ) and 30mg or 60mg iron with 400 gm folic acid , or multiple micronutrients ( Fe30F , Fe60F , MMS ) resulting in six randomization groups , EFe30F , UFe30F , EFe60F , UFe60F , EMMS , and UMMS ( n = 4436 ) .


Included in analysis after omissions ( fetal loss and out-migration ) were 3625 women and 3659 live births of which 3591 had information on maternal schooling .


The study site was rural Matlab , Bangladesh .


The main stratifying variable was maternal schooling dichotomized as < 6years and 6years .


We used Cox proportional hazard model for survival analyses .


Overall , women having < 6 years of schooling adhered more to food ( 81 vs. 69 packets , P = 0.0001 ) but a little less to micronutrient ( 104 vs. 120 capsules , P = 0.0001 ) supplementation compared to women having more schooling , adjusted for maternal age ( years ) , parity and body mass index ( BMI , kg/m2 ) at week 8 pregnancy .


Children of mothers with 6years of schooling had lower under-five mortality , but the EMMS supplementation reduced the social difference in mortality risk ( using standard program and schooling < 6years as reference ; standard program and schooling 6years HR 0.54 , 95 % CI 0.27-1 .11 ; EMMS and schooling 6years HR 0.28 , 95 % CI 0.12-0 .70 ; EMMS and schooling < 6years HR 0.26 , 95 % CI 0.11-0 .63 ) , adjusted for maternal age ( years ) , parity and body mass index ( kg/m2 ) at week 8 pregnancy .


The combination of an early invitation to prenatal food supplementation and multiple micronutrient supplementation lowered mortality in children before the age of five years and reduced the gap in child survival chances between social groups .


The pattern of adherence to the supplementations was complex ; women with less education adhered more to food supplementation while those with more education had higher adherence to micronutrients .


ISRCTN16581394 .


To create a risk model for neovascular age-related macular degeneration ( nAMD ) based on nongenetic factors .


In this case-control study , 1459 individuals were included , 445 patients showed nAMD and 1014 were healthy controls .


Participants were randomly assigned into a training set ( containing two-thirds of individuals ) and a validation set .


Stepwise logistic regression analysis was performed for 25 environmental risk factors in the training set .


The risk model with the remaining factors was then validated in the validation set using receiver operating characteristics ( ROC ) curve and Hosmer-Lemeshow-Test .


Additionally , a genetic risk model including variants in the complement factor H gene ( CFH , rs1061170 ) and the age-related maculopathy susceptibility 2 gene ( ARMS2 , rs10490924 ) was generated .


The environmental risk model with the factors age , alcohol use , allergy , education , sunlight exposure , fish consumption , and physical exercise showed an AUC of 0.80 ( 95 % confidence interval [ CI ] 0.76-0 .84 ) in the training set .


Validation of the model showed adequate calibration ( Hosmer-Lemeshow P = 0.81 ) .


The AUC for the genetic model was 0.77 ( 95 % CI 0.730-0 .808 ) , for the combined environmental and genetic model 0.92 ( 95 % CI 0.887-0 .947 ) .


Seven nongenetic factors are able to provide equivalent discrimination between nAMD patients and controls to genetic risk models .


Most of them are modifiable and give the opportunity for counseling patients .


The surgical wound of total knee arthroplasty ( TKA ) needs continuous flexion and extension movement .


Silicone gel treatment is widely used to treat hypertrophic scars and keloids since it is easily applied and prevents scar pain and itching .


The aim of this study was to evaluate the clinical efficacy and safety of silicone gel applied to surgical scars of TKA on postoperative scar pain and pruritus .


One hundred TKAs were randomized into a silicone gel group ( silicone gel was applied to the wound after stitch-out for 1 month ) or a placebo group .


The postoperative scar pain and pruritus were evaluated with the use of a visual analog scale ( VAS ) at postoperative 3 months , 6 months and 1 year .


Scar assessment was done using the Vancouver scar scale by evaluating scar pigmentation , vascularity , pliability , and height .


Although silicone gel group showed better pigmentation and height scales than placebo group ( P < 0.05 ) , there were no significant differences in the postoperative scar pain and pruritus VAS scores between the groups ( P > 0.05 ) .


Application of silicone gel had no beneficial effects on scar pain and itching relief during the early postoperative period of TKA .


I-Randomized Controlled Trial .


Two treatment strategies were compared in patients with type 2 diabetes ( T2DM ) on basal insulin requiring intensification : addition of once-daily ( OD ) liraglutide ( Lira ) or OD insulin aspart ( IAsp ) with largest meal .


Subjects completing 104weeks ( 52-week main trial BEGIN ONCE-LONG + 52-week extension ) on insulin degludec ( IDeg ) OD + metformin with HbA1c7 .0 % ( 53mmol/mol ) were randomized to IDeg + Lira [ n = 88 , mean HbA1c : 7.7 % ( 61mmol/mol ) ] or IDeg + IAsp ( n = 89 , mean HbA1c : 7.7 % ) for 26weeks , continuing metformin .


Subjects completing 104weeks with HbA1c < 7.0 % continued IDeg + metformin in a third , non-randomized arm ( n = 236 ) .


IDeg + Lira reduced HbA1c ( -0.74 % - points ) significantly more than IDeg + IAsp ( -0.39 % - points ) ; estimated treatment difference ( ETD ) ( IDeg + Lira-IDeg + IAsp ) -0.32 % - points ( 95 % CI -0.53 ; -0.12 ) ; p = 0.0024 .


More IDeg + Lira ( 49.4 % ) than IDeg + IAsp ( 7.2 % ) subjects achieved HbA1c < 7.0 % without confirmed hypoglycaemia [ plasma glucose < 3.1 mmol/l ( < 56mg/dl ) or severe hypoglycaemia ) and without weight gain ; estimated odds ratio ( IDeg + Lira/IDeg + IAsp ) 13.79 ( 95 % CI 5.24 ; 36.28 ) ; p < 0.0001 .


IDeg + Lira subjects had significantly less confirmed and nocturnal confirmed hypoglycaemia , and significantly greater weight loss ( -2.8 kg ) versus IDeg + IAsp ( +0.9 kg ) ; ETD ( IDeg + Lira-IDeg + IAsp ) -3.75 kg ( 95 % CI -4.70 ; -2.79 ) ; p < 0.0001 .


Other than more gastrointestinal side effects with IDeg + Lira , no safety differences occurred .


Durability of IDeg was established in the non-randomized arm , as mean HbA1c remained < 7.0 % [ mean 6.5 % ( 48mmol/mol ) at end-of-trial ] .


IDeg + Lira improved long-term glycaemic control , with weight loss and less hypoglycaemia versus adding a single daily dose of IAsp in patients with T2DM inadequately controlled with IDeg + metformin .


The effects of i.v. remifentanil in combination with an inhaled anesthetic to facilitate tracheal extubation of deeply anesthetized adults after otologic surgery are investigated .


Fifty patients undergoing middleear surgery were recruited for the study .


All patients were administered deep anesthesia ( i.v. fentanil , propofol , and mivacurium ) and intubated , with subsequent administration of inhaled sevoflurane for anesthesia maintenance .


Prior to endotracheal tube removal , the patients received i.v. dexamethasone , ondansetron hydrochloride , and parecoxib and were randomly allocated to two groups .


In group S ( n = 25 ) , anesthesia was maintained with sevoflurane alone ( 1.3 times the minimum effective alveolar concentration [ MAC ] ) , while patients in group SR ( n = 25 ) received low-dose i.v. remifentanil and a reduced dose of sevoflurane ( 1.0 MAC ) .


The mean remifentanil dosage was 0.028 g/kg per minute .


Relative to patients in group S , patients in group SR had a significantly lower mean respiratory rate ( 6.4 breaths per minute versus 15.8 breaths per minute , p < 0.01 ) and end-tidal carbon dioxide pressure ( 48.1 mm Hg versus 52.1 mm Hg , p < 0.05 ) after extubation .


Postextubation airway obstructions requiring nasal airway placement were less frequent in group SR ( 14 cases versus 2 cases in group S , p < 0.05 ) ; patients in group SR also had a shorter mean time to awakening ( 19.5 minutes versus 15.8 minutes , p < 0.05 ) and a shorter mean time to orientation ( 31.4 minutes versus 26.1 minutes , p < 0.05 ) .


Sevoflurane combined with remifentanil provided rapid recovery and appeared to be safe for deep-anesthesia tracheal extubation in adult patients after otologic surgery .


Evaluate the effect of high-oleic and conventional peanuts within a hypocaloric-diet on energy metabolism and body composition .


This 4-week randomized clinical trial included males with BMI of 29.72.4 kg m ( -2 ) and aged between 18 and 50 years .


Participants were assigned to the groups : control ( CT , n = 22 ) that followed a hypocaloric-diet ; conventional peanuts ( CVP , n = 22 ) or high-oleic peanuts ( HOP , n = 21 ) that received the hypocaloric-diet including ( not adding ) 56 g day ( -1 ) of peanuts .


Glucose , fat oxidation , and body fatness and lean mass were the main outcomes .


Body weight and composition did not differ between groups .


However , within group total body fat ( kg ) reduced with CVP and HOP , with a significant decrease in body fat percentage in HOP .


While total lean mass ( kg ) decreased in CT , total lean mass ( % ) increased in HOP .


Truncal lean mass decreased in the CT. .


At baseline , HOP had greater postprandial fat oxidation than the CVP .


After 4-weeks , fasting fat oxidation increased in CVP and HOP .


Fat oxidation increased in CT and HOP during the 200 min after meal intake compared to the fasting condition .


Regular peanut consumption , especially the high-oleic type , within a hypocaloric-diet increased fat oxidation and reduced body fatness in overweigh and obese men .


To determine the effects of the herbal fixed-dose combination PRO 160/120 ( extracts from saw palmetto fruits and stinging nettle roots ) on nocturnal voiding frequency , as measured by question 7 of the IPSS questionnaire , in patients with moderate-to-severe LUTS/BPH after 24 weeks of treatment compared to placebo , to the - blocker tamsulosin , or to the 5-reductase inhibitor finasteride .


The study is about post hoc evaluation of four published randomized , double-blind clinical trials on PRO 160/120 , two compared with placebo , one with finasteride and one with tamsulosin .


In addition , a pooled data analysis of the two placebo-controlled trials was conducted .


We analyzed data from a total of 922 patients with a mean age of 66 years and a mean baseline nocturnal voiding frequency of 2.1 .


In the pooled analysis of placebo-controlled trials , nocturnal voids improved by 0.8 ( 29 % ) with PRO 160/120 compared to 0.6 ( 18 % ) with placebo ( p = 0.015 , Wilcoxon test , one-tailed ) .


The 69 % responder rate to PRO 160/120 was significantly superior to the placebo response ( 52 % ; p = 0.003 , ( 2 ) - test , two-tailed ) .


The majority of responders improved by 1 void/night .


Absolute improvements and response rates were consistently higher with PRO 160/120 than with placebo over a range of baseline nocturnal voiding frequencies .


There were no differences between PRO 160/120 and finasteride or tamsulosin regarding absolute improvement of nocturnal voids or responds rates .


PRO 160/120 significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride .


That patients with acute radiculopathy caused by lumbar disc herniation ( LDH ) will benefit from spinal manipulation ( SM ) treatment has been taken for granted , despite no solid evidence to support that claim .


There is a demand for a win-win SM treatment that is both effective and less risky , and we attempt to use this trial to demonstrate such a treatment .


In this study , Feng 's Spinal Manipulative Therapy ( FSM ) is selected as the observational SM .


FSM can be performed with either manipulation or mobilization , and also can be easily mimicked as a sham SM .


Two hundred and sixteen qualified hospitalized participants will be randomly allocated to one of the three following groups : sham SM , mobilization , or manipulation , according to a ratio of 1:1:1 .


Participants in each group will receive specific FSM treatments four times , along with basic therapies over a course of 2 weeks .


Two days after each SM appointment , risk outcomes will be assessed using a questionnaire developed to identify accompanying unpleasant reactions ( AUR ) .


The pain pressure threshold ( PPT ) will be measured paraspinally on the tender spot beside the involved joint before and immediately after each SM treatment .


Relative risk ( RR ) of AUR , number needed to harm ( NNH ) and the 95 % confidence intervals of each group will be calculated and compared .


Benefit outcomes will be assessed by analyzing the following data recordings : the Numerical Rating Scale ( NRS ) , Oswestry Disability Index ( ODI ) , and Global Perceived Effect ( GPE ) before enrollment and at the 7th , and 15th day after the treatment .


Analyses will include comparisons of NRS , ODI and changes at the different visit times among the three groups by Repeated Measures Data ANOVA , an evaluation of reduced scores of NRS and ODI after the therapy to determine if they meet the minimum acceptable outcome ( MAO ) , and the determination of the minimal clinically important difference ( MCID ) by the average improvement in NRS and ODI scores of all participants who have been allocated to the category ` improved ' on the GPE assessment .


This trial is registered in Chinese Clinical Trial Register ( ChiCTR ) on 19 August 2013 ( ChiCTR-TRC-13003496 ) .


To compare the differences in the efficacy on depression after breast cancer operation treated with auricular point sticking therapy , the combined program of auricular point sticking therapy and TCM psychotherapy and medication with deanxit .


Ninety patients were randomized into 3 groups , 30 cases in each one .


In the western medication group , the simple oral administration of deanxit was applied , one tablet a day .


In the auricular point group , Xin ( GO15 ) , Shen ( CO10 ) , Gan ( CO12 ) , Shenmen ( TF4 ) , Pizhixia ( AT ) , Neifenmi ( CO18 ) were selected and stimulated with auricular point sticking on either side in each treatment , once a week .


In the combined program group , on the basis of the treatment as the auricular point group , TCM psychotherapy was combined with .


The treatment of 4 weeks made one session .


One session and 4 weeks follow-up were required .


The self-rating depression scale ( SDS ) was used to compare the score before and after treatment in the patients of each group and the efficacy was assessed .


( 1 ) Compared with those before treatment , in 4 weeks of treatment and 4 weeks of follow-up , SDS scores were all reduced apparently in the 3 groups ( all P < 0.001 ) .


After 4 weeks of follow-up in the auricular point group , after 2 and 4 weeks of treatment and 4 weeks of follow-up in the combined program group , SDS scores were all lower than those in the western medication group ( all P < 0.05 ) .


( 2 ) After 4 weeks of treatment , the curative rate in the combined program group was higher than that in the auricular point group and the western medication group [ 60.0 % ( 18/30 ) vs. 40.0 % ( 12/30 ) , 36.7 % ( 11/30 ) , both P < 0.05 ) ] .


After 4 weeks of follow-up , the curative rate in either the combined program group or the auricular point group was higher than that in the western medication group [ 60.0 % ( 18/30 ) , 30.0 % ( 19/30 ) vs. 23.3 % ( 7/30 ) , both P < 0.05 ] .


The auricular point sticking therapy , the combined program of auricular point sticking therapy and TCM psychotherapy , and medication with deanxit all relieve depression after breast cancer operation .


The efficacy of the combined program with auricular point sticking therapy and TCM psychotherapy involved is the best , and the efficacy of the auricular point sticking therapy is better than the oral administration of deanxit .


Postoperative nausea and vomiting ( PONV ) are significant problems in laparoscopic surgery .


Compare the prophylactic use of metoclopramide and its combination with dexamethasone in the prevention of PONV in patients undergoing laparoscopic cholecystectomy ( LC ) .


One hundred patients aged 18 to 75 with American Society of Anesthesiologists ( ASA ) class 1-2 who candidates for elective LC at Chiang Mai University Hospital , were included in this double-blind , randomized controlled trial ( parallel design ) .


Patients were randomly divided into two groups , by ` Block offour ` randomization .


Treatment group received 8 mg dexamethasone and 10 mg metoclopramide , and control group received 10 mg metoclopramide and normal saline solution 1.6 ml .


These medications were administered intravenously when the gallbladder was removedfrom gallbladder bed .


All of investigators , anesthetists , patients , care providers , and outcome assessor were blinded .


Patients were asked to assess their nausea and vomiting at 2 , 6 , 12 , and 24 hours postoperatively , and at discharge .


The overall score of PONV in each patient based on afour-point whole number of nausea and vomiting by verbal rating scale 0-3 ( 0 = no nausea and vomiting , 1 = nausea , 2 = nausea with vomiting , and 3 = repeated vomiting > 2 times ) .


Fifty eligible patients were randomized to each group , and all were analyzed .


There were no significant differences between baseline characteristics of patients in the two groups .


The combination of dexamethasone and metoclopramide indicated a greater antiemetic effect with significant statistical analysis , odds ratio = 0.25 ( 95 % confidence interval O. 11-0 .55 , p = 0.001 ) .


Thepostoperative hospital stay in the combined group and metoclopramide group were , 1 day = 47 ( 94 % ) and 37 ( 74 % ) , > 1 day = 3 ( 6 % ) and 13 ( 26 % ) , respectively ( p = 0.012 ) .


There were no postoperative complications occurred in both groups .


Intravenous administration of dexamethasone combined with metoclopramide had significant effects in prophylaxis of nausea and vomiting after LC and shorten the hospital stay .


Clinical trials registration number : TCTR20140128001


The prevalence of type 2 diabetes ( T2D ) in youth is increasing .


Treatment options beyond metformin and insulin are needed .


The safety , tolerability , pharmacokinetics , and pharmacodynamics of liraglutide once daily in youth ( 10-17 years old ) with T2D were investigated in a randomized , double-blind , placebo-controlled trial .


Youth treated with diet/exercise alone or with metformin and having a hemoglobin A1c ( HbA1c ) level of 6.5-11 % were randomized to liraglutide ( n = 14 ) or placebo ( n = 7 ) .


Starting at 0.3 mg/day , doses were escalated weekly to 0.6 , 0.9 , 1.2 , and 1.8 mg/day ( or placebo equivalent ) for 5 weeks .


Nineteen participants completed the trial .


Baseline characteristics were similar between groups , with mean ( SD ) values for age of 14.8 ( 2.2 ) years , weight of 113.2 ( 35.6 ) kg ( range , 57-214 kg ) , diabetes duration of 1.7 ( 1.4 ) years , and HbA1c level of 8.1 % ( 1.2 % ) .


No serious adverse events ( AEs ) , including severe hypoglycemia , occurred .


Transient gastrointestinal AEs were most common at lower liraglutide doses during dose escalation .


No significant changes in safety and tolerability parameters occurred .


There was no evidence of pancreatitis or lipase elevations above three times the upper normal limit ; calcitonin levels remained within the normal range .


For liraglutide 1.8 mg , mean half-life was 12 h , and clearance was 1.7 L/h .


After 5 weeks , the decline in HbA1c level was greater with liraglutide versus placebo ( -0.86 vs. 0.04 % , P = 0.0007 ) , whereas mean body weight remained stable ( -0.50 vs. -0.54 kg , P = 0.9703 ) .


Liraglutide was well tolerated in youth with T2D , with safety , tolerability , and pharmacokinetic profiles similar to profiles in adults .


We investigated single nucleotide polymorphisms ( SNPs ) of thrombospondin-1 ( TSP-1 ) on the risk of corneal allograft rejection .


The TSP-1 is known to be involved in the immune response of the anterior chamber of the eye , activating TGF-2 , promoting peripheral and systemic tolerance , and counteracting the proangiogenic activity of VEGF .


Three tagging SNPs spanning the TSP-1 region ( rs1478604 , A > G ; rs2228261 , C > T ; and rs2228262 , A > G ) were genotyped .


Association with risk of rejection was investigated in a group of 378 corneal transplant recipients with risk factors for allograft rejection .


Transplant recipients had completed 3-year follow-up .


The TSP-1 rs1478604 A SNP was associated significantly with an increased risk of corneal allograft rejection ( odds ratio [ OR ] , 1.58 ; 95 % confidence interval [ CI ] , 1.02-2 .45 ; P = 0.04 ) and there was a trend toward the rs1478604 , rs2228261 , rs2228262 ACA haplotype increasing risk of rejection .


The results suggest that TSP-1 rs1478604 AA homozygotes may be at increased risk of corneal transplant rejection , especially if they carry the ACA haplotype .


Evolocumab ( AMG 145 ) , a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , significantly reduced low-density lipoprotein cholesterol ( LDL-C ) in phase 2 studies of 12 weeks ' duration .


The longer-term efficacy and safety of PCSK9 inhibition remain undefined .


Of 1359 randomized and dosed patients in the 4 evolocumab phase 2 parent studies , 1104 ( 81 % ) elected to enroll into the Open-Label Study of Long-term Evaluation Against LDL-C ( OSLER ) study .


Regardless of their treatment assignment in the parent study , patients were randomized 2:1 to receive either open-label subcutaneous evolocumab 420 mg every 4 weeks with standard of care ( SOC ) ( evolocumab + SOC , n = 736 ) or SOC alone ( n = 368 ) .


Ninety-two percent of patients in the evolocumab + SOC group and 89 % of patients in the SOC group completed 52 weeks of follow-up .


Patients who first received evolocumab in OSLER experienced a mean 52.3 % [ SE , 1.8 % ] reduction in LDL-C at week 52 ( P < 0.0001 ) .


Patients who received 1 of 6 dosing regimens of evolocumab in the parent studies and received evolocumab + SOC in OSLER had persistent LDL-C reductions ( mean reduction , 50.4 % [ SE , 0.8 % ] at the end of the parent study versus 52.1 % [ SE , 1.0 % ] at 52 weeks ; P = 0.31 ) .


In patients who discontinued evolocumab on entry into OSLER , LDL-C levels returned to near baseline levels .


Adverse events and serious adverse events occurred in 81.4 % and 7.1 % of the evolocumab + SOC group patients and 73.1 % and 6.3 % of the SOC group patients , respectively .


Evolocumab dosed every 4 weeks demonstrated continued efficacy and encouraging safety and tolerability over 1 year of treatment in the largest and longest evaluation of a PCSK9 inhibitor in hypercholesterolemic patients to date .


http://clinicaltrials.gov .


Unique identifier : NCT01439880 .


There is a need to identify innovative , low-cost and broad-reaching strategies for promoting exercise and improving physical function in older adults with multiple sclerosis ( MS ) .


This randomised controlled pilot trial will test the efficacy of a 6-month , DVD-delivered exercise intervention to improve functional performance and quality of life in older adults with MS. Participants will be randomised either into a DVD-delivered exercise condition or an attentional control condition .


This novel approach to programme delivery provides participants with detailed exercise instructions which are presented in a progressive manner and includes a variety of modifications to better meet varying levels of physical abilities .


The targeted exercises focus on three critical elements of functional fitness : flexibility , strength and balance .


It is hypothesised that participants who are randomised to the exercise DVD condition will demonstrate improvements in physical function compared with participants assigned to the attentional control condition .


Data analysis will include a 2 ( condition ) 2 ( time ) mixed factor analysis of variance ( ANOVA ) that follows intent-to-treat principles , as well as an examination of effect sizes .


Participants will take part in qualitative interviews about perspectives on physical activity and programme participation .


The study protocol was approved by a university institutional review board and registered with a federal database .


Participants will be asked to read and sign a detailed informed consent document and will be required to provide a physician 's approval to participate in the study .


The exercise DVDs include an overview of safety-related concerns and recommendations relative to exercise participation , as well as detailed instructions highlighting the proper execution of each exercise presented on screen .


Following completion of this trial , data will be immediately analysed and results will be presented at scientific meetings and published in scholarly journals .


Clinical Trials NCT01993095 .


Poverty undermines the adherence of patients to tuberculosis treatment .


A pragmatic cluster randomized controlled trial was conducted to investigate the extent to which economic support in the form of a voucher would improve patients ' adherence to treatment , and their treatment outcomes .


Although the trial showed a modest improvement in the treatment success rates of the intervention group , this was not statistically significant , due in part to the low fidelity to the trial intervention .


A qualitative process evaluation , conducted in the final few months of the trial , explained some of the factors that contributed to this low fidelity .


In-depth interviews were conducted with patients who received vouchers , nurses in intervention clinics , personnel in shops who administered the vouchers , and managers of the TB Control Programme .


These interviews were analyzed thematically .


The low fidelity to the trial intervention can be explained by two main factors .


The first was nurses ' tendency to ` ration ' the vouchers , only giving them to the most needy of eligible patients and leaving out those eligible patients whom they felt were financially more comfortable .


The second was logistical issues related to the administration of the voucher as vouchers were not always available for patients on their appointed clinic dates , necessitating further visits to the clinics which they were not always able to make .


This process evaluation identifies some of the most important factors that contributed to the results of this pragmatic trial .


It highlights the value of process evaluations as tools to explain the results of randomized trials and emphasizes the importance of implementers as ` street level bureaucrats ' who may profoundly affect the way an intervention is administered .


Current Controlled Trials ISRCTN50689131 , registered 21 April 2009 .


The trial protocol is available at the following web address : http://www.hst.org.za/publications/study-protocol-economic-incentives-improving-clinical-outcomes-patients-tb-south-africa .


India has 275 million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year .


There is an urgent need to develop and evaluate affordable , practicable and scalable interventions to promote cessation of tobacco use .


Because tobacco use is so harmful , an increase of as little as 1 percentage point in long-term quit success rates can have an important public health impact .


This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India .


This is a pragmatic , two-arm , community-based cluster randomized controlled trial focused on tobacco users in low-income communities .


The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises ( BA-YBA ) and the control arm is very brief advice ( VBA ) .


Of a total of 32 clusters , 16 will be allocated to the intervention arm and 16 to the control arm .


Each cluster will have 31 participants , making a total of 992 participants .


The primary outcome measure will follow the Russell Standard : self-report of sustained abstinence for at least 6 months following the intervention confirmed at the final follow-up by salivary cotinine .


This trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications .


Short children born small for gestational age ( SGA ) are treated with a GH dose based on body size , but treatment may lead to high levels of IGF1 .


The objective was to evaluate IGF1 titration of GH dose in contrast to current dosing strategies .


In the North European Small-for-Gestational-Age Study ( NESGAS ) , 92 short pre-pubertal children born SGA were randomised after 1 year of high-dose GH treatment ( 67g/kg per day ) to three different regimens : high dose ( 67g/kg per day ) , low dose ( 35g/kg per day ) or IGF1 titration .


The average dose during the second year of the randomised trial did not differ between the IGF1 titration group ( 38g/kg per day , s.d. 0.019 ) and the low-dose group ( 35g/kg per day , s.d. 0.002 ; P = 0.46 ) , but there was a wide variation in the IGF1 titration group ( range 10-80g / kg per day ) .


The IGF1 titration group had significantly lower height gain ( 0.17 SDS , s.d. 0.18 ) during the second year of the randomised trial compared with the high-dose group ( 0.46 SDS , s.d. 0.25 ) , but not significantly lower than the low-dose group ( 0.23 SDS , s.d. 0.15 ; P = 0.17 ) .


The IGF1 titration group had lower IGF1 levels after 2 years of the trial ( mean 1.16 , s.d. 1.24 ) compared with both the low-dose ( mean 1.76 , s.d. 1.48 ) and the high-dose ( mean 2.97 , s.d. 1.63 ) groups .


IGF1 titration of GH dose in SGA children proved less effective than current dosing strategies .


IGF1 titration resulted in physiological IGF1 levels with a wide range of GH dose and a poorer growth response , which indicates the role of IGF1 resistance and highlights the heterogeneity of short SGA children .


To quantify the effect of food on the systemic exposure of lapatinib at steady state when administered 1 h before and after meals , and to observe the safety and tolerability of lapatinib under these conditions in patients with advanced solid tumours .


This was a three-treatment , randomised , three-sequence cross-over study .


Lapatinib was administered 1 h after a low - [ B ] or a high-fat [ C ] meal and systemic exposure was compared with that obtained following administration 1 h before a low-fat meal [ A ] .


In total , 25 patients were included , of whom 12 were evaluable for the pharmacokinetic analysis .


Both low-fat and high-fat meals affected lapatinib exposure .


Lapatinib AUC0-24 increased following lapatinib administration 1 h after a low-fat meal by 1.80-fold ( 90 % CI : 1.37-2 .37 ) and after a high-fat meal by 2.61-fold ( 90 % CI : 1.98-3 .43 ) .


Lapatinib Cmax increased following lapatinib administration 1 h after a low-fat meal by 1.90-fold ( 90 % CI : 1.49-2 .43 ) and after a high-fat meal by 2.66-fold ( 90 % CI : 2.08-3 .41 ) .


The most commonly occurring treatment-related toxicity was diarrhoea ( 8/25 , 32 % CTCAE grade 1 and 2/25 , 8 % grade 2 ) and one treatment-related grade3 event occurred ( fatigue grade 3 , 4 % ) .


Both low-fat and high-fat food consumed 1 h before lapatinib administration increased lapatinib systemic exposure compared with lapatinib administration 1 h before a low-fat meal .


In order to administer lapatinib in a fasted state , it is advised to administer the drug 1 h before a meal .


Inserting a nasogastric tube ( NGT ) in intubated patients may be difficult because they can not follow swallowing instructions , resulting in a high rate of first-attempt failure .


We introduce a simple technique for inserting an orogastric tube in an emergency department ( ED ) .


Fifty-six patients in the ED , who were intubated and required NGT insertion , were randomly allocated to 2 groups .


We inserted the NGT using a conventional technique from the nostril ( control group ) and an endotracheal tube ( ET ) - assisted technique from the mouth ( ET group ) .


The procedures ' success rate , insertion duration , and complications were compared between the groups .


There was a significantly higher overall success rate in the ET group than the control group ( 100 % vs 64 % , P < .001 ) .


Endotracheal tube group showed 100 % first-attempt success rate , but 50 % of the control group failed at first attempt .


Mean duration of the first trial was not significantly different between the ET and control groups ( 58.016.9 vs 57.329.5 seconds , P = .903 ) , but total time for successful insertion was longer in the control group than the ET group ( 58.016.9 vs 111.774.5 seconds , P < .001 ) .


There was less NGT kinking and more mucosal bleeding in the ET group than in the control group ( 0 % vs 16 % , P = .019 ; 16 % vs 7 % , P = .225 , respectively ) .


Endotracheal tube-assisted orogastric tube insertion technique showed a higher rate of successful insertion and shorter total duration .


With this result , ET-assisted orogastric tube insertion would be useful in ED .


Intramuscular botulinum toxin-A ( BoNT-A ) injections reduce spasticity by blocking neurotransmission at the motor endplate ( MEP ) .


The goal of this study was to assess the reduction in spasticity achieved by injecting BoNT-A at different sites of the gracilis muscle .


Thirty-four gracilis muscles , in 27 children ( 10 females and 17 males , mean age of 8.6 y [ SD 2.5 y ] ) with spastic cerebral palsy ( unilateral and bilateral , Gross Motor Function Classification System [ GMFCS ] levels I-IV ) , were randomly assigned to one of two groups .


In one group BoNT-A was injected proximally ( at a site 25 % of the distance from the pubic tubercle and the medial epicondyle ) and in the other it was injected at the MEP zones ( half of the dose was administered at 30 % of this distance and half at 60 % ) .


Spasticity was assessed before and after BoNT-A injection using simultaneous measurements of surface electromyography ( sEMG ) and angular velocity during passive muscle stretch applied at different velocities .


The primary outcome measure included the velocity-dependent change in average root mean square electromyography ( RMS-EMG ) .


Secondary outcome was assessed with the Modified Ashworth Scale ( MAS ) and Modified Tardieu Scale ( MTS ) .


Spasticity decreased more in MEP-targeted muscles than in proximally injected muscles , as demonstrated by a larger reduction in average RMS-EMG values ( p = 0.04 ) , though this difference was not found with the MAS or MTS .


The results suggest that BoNT-A injection of the gracilis at sites with a high concentration of MEPs is effective at reducing spasticity .


These preliminary findings should be confirmed by larger studies .


In the case of long muscles , such as the gracilis , the injection site is important .


More than 50 % of patients with advanced breast cancer develop bone metastases that may lead to multiple complications such as pathological fractures , bone pain or hypercalcaemia .


The standard treatment , besides endocrine , targeted-therapy or chemotherapy , is the use of bisphosphonates .


However , one of their main adverse side-effects is bisphosphonate-induced nephrotoxicity .


The mechanism by which the latter occurs is not well-understood , although emerging evidence suggests that the effect of bisphosphonates on the kidney may differ between agents .


The aim of this evaluation was to compare the renal toxicity of 6 mg ibandronate i.v. versus 4 mg zoledronic acid i.v. over a period of six months in women with breast cancer and bone metastases .


A prospective randomized trial was carried out to examine specific kidney and other parameters ( 1 - and 2-microglobulin , albumin , 2-macroglobulin , IgG and C-reactive protein ( CRP ) generated from spontaneous urine samples from 17 patients of each group .


We were unable to find any significant difference between the two treatment groups with regard to renal toxicity .


All patients , independently of the applied bisphosphonate , experienced only temporary renal dysfunction without any evidence of irreversible damage in terms of acute nephrotoxicity during the study period .


1-Microglobulin , a marker for proximal tubular damage , in particular , was not differently elevated in either group .


Both applied bisphosphonates were found to be well-tolerated and safe with regard to renal toxicity during a six-month treatment period in patients with otherwise healthy kidneys having advanced breast cancer and bone metastases .


In adults with Williams-Beuren syndrome ( WBS ) , a common endocrine abnormality is type 2 diabetes mellitus ( T2DM ) or impaired glucose tolerance ( IGT ) .


However , few and sporadic data are available in children , adolescents , and young adults with WBS .


To evaluate the frequency of IGT and T2DM in a cohort of children and young patients with WBS .


We longitudinally evaluated 27 patients ( 9 males and 18 females , median age at study onset 13.6 years ) with WBS .


The median follow-up was 3.6 years .


Variables of insulin resistance and - cell function were evaluated in all subjects using an oral glucose tolerance test .


The homeostasis model assessment ( HOMA ) of insulin resistance and the Matsuda index of insulin sensitivity were calculated .


The study of the GCK and HNF1 genes was performed in patients with glucose metabolism abnormalities .


45 age - and sex-matched healthy subjects and 51 age - , sex - and BMI-matched subjects were recruited as two control groups .


Considering nutritional status , 7 ( 25.9 % ) patients were obese , 9 ( 33.3 % ) overweight , and 11 ( 40.8 % ) normal-weight .


One ( 3.1 % ) patient had acanthosis nigricans .


IGT was diagnosed in 7 ( 25.9 % ) WBS patients and T2DM in 3 ( 11.1 % ) .


Considering all WBS patients , the median value of HOMA was 5.23 ( range 2.93-14 .89 ; insulin 24.73 14.67 U/ml ; glucose 104.98 16.06 mg/dl ) .


Considering BMI values , HOMA was 11.00 ( range 6.53-12 .56 ) , 5.64 ( range 3.54-7 .95 ) , and 4.54 ( range 3.21-5 .43 ) , and insulin was 34.53 6.84 , 22.76 8.91 , and 19.47 6.01 U/ml in obese , overweight , and normal-weight WBS patients , respectively .


Comparing the results with the two control groups , WBS patients showed higher insulin values than healthy controls ( p < 0.001 ) , but similar values as the BMI-matched control group ( p = n.s. ) .


However , WBS patients showed significantly higher values of glycemia ( healthy control group , p < 0.001 ; BMI-matched control group , p < 0.05 ) and HOMA ( healthy control group , p < 0.001 ; BMI-matched control group , p < 0.05 ) than the two control groups .


Finally , among WBS patients there was a higher number of subjects with IGT and T2DM than among healthy controls ( p < 0.0001 ) and the BMI-matched control group ( p = 0.0002 ) .


Our data strongly suggest that IGT and T2DM may be frequently discovered in children , adolescents , and young adults with WBS .


WBS should be included among the genetic syndromes associated with T2DM .


Further studies are necessary to evaluate the etiopathogenesis of this aspect .


With a prevalence of 3 to 8 % among women of reproductive age , severe premenstrual symptoms are very common .


Symptoms range from emotional and cognitive to physical changes .


Severe symptoms ( that is , premenstrual syndrome ) can have a strong impact on everyday functioning and quality of life .


Impairment can be as serious as that of dysthymic disorders .


Many affected women receive either no treatment at all or are unsatisfied with their treatment .


Although there is some evidence for the reduction of distress through cognitive behavioural therapy , there are only a small number of randomised controlled trials carefully investigating the efficacy of this psychotherapeutic approach .


Thus , this study aims to evaluate the efficacy of a cognitive behavioural self-help treatment for women suffering from premenstrual syndrome .


The study is conducted as a randomised controlled trial .


The complex diagnostic assessment includes the completion of a symptom diary over two consecutive cycles and a telephone interview .


Eligible women are randomly assigned to either a treatment or a wait-list control group .


The intervention is based on cognitive behavioural therapy principles and is provided via the internet .


It consists of 14 different modules on which participants work over 8 consecutive weeks .


In addition to written information , participants receive email feedback from a clinical psychologist on a weekly basis .


Participants assigned to the wait-list receive the treatment after the end of the waiting period ( 8 weeks ) .


The primary outcome measure is the Premenstrual Syndrome Impairment Measure .


Secondary outcomes include the Premenstrual Syndrome Coping Measure , the Short-Form Social Support Questionnaire , the Questionnaire for the Assessment of Relationship Quality , and the Perceived Stress Scale .


Data is collected during the premenstrual ( luteal ) phase at pre-treatment , post-treatment , and 6-month follow-up .


So far , there is no study investigating internet-based cognitive behavioural therapy for premenstrual syndrome .


The programme approaches the problem of high prevalence in combination with severe impairment and insufficient treatment options .


ClinicalTrials.gov : NCT01961479 , 9 October 2013 .


In North America , few studies have evaluated sublingual immunotherapy for allergic rhinitis with or without conjunctivitis ( AR/C ) ; pediatric data are sparse .


The authors report findings from the largest published immunotherapy trial yet conducted in adults and children .


To evaluate grass sublingual immunotherapy tablet ( MK-7243 ) treatment in subjects with AR/C .


North American subjects ( 5-65 years old ) with grass allergy were randomized 1:1 to once-daily MK-7243 ( 2,800 BAU Phleum pratense ) or placebo .


The first dose was given at the investigator 's office ; subsequent doses were self-administered at home .


The primary end point was total combined score ( TCS ; rhinoconjunctivitis daily symptom score [ DSS ] plus daily medication score [ DMS ] ) over the entire grass pollen season ( GPS ) .


Key secondary end points included entire-season DSS , DMS , peak-season TCS , and rhinoconjunctivitis quality-of-life questionnaire scores .


Safety outcomes included adverse events ( AEs ) .


One thousand five hundred one subjects were randomized ( 85 % polysensitized , 25 % had asthma ) .


MK-7243 yielded improvements vs placebo of 23 % in entire-season TCS ( median difference-0 .98 , P < .001 ) , 29 % in peak-season TCS ( median difference-1 .33 , P < .001 ) , 20 % in entire-season DSS ( median difference-0 .64 , P = .001 ) , 35 % in entire-season DMS ( mean difference-0 .48 , P < .001 ) , and 12 % in peak-season rhinoconjunctivitis quality-of-life questionnaire ( median difference-0 .13 , P = .027 ) .


Efficacy between children and adults was similar .


Most AEs were transient local application-site reactions , with no serious treatment-related AEs or anaphylactic shock .


Three subjects ( 1 placebo , 2 MK-7243 ) had moderate systemic allergic reactions .


MK-7243 was effective in polysensitized grass-allergic North American children and adults with AR/C in this large trial , confirming previous research .


Pregnant women are the highest priority group for annual influenza vaccination .


Studies have shown unacceptably low uptake of both seasonal and pandemic A/H1N1 influenza vaccination among pregnant women .


This paper will describe the study protocol and methodology of a randomised controlled trial designed to assess the effectiveness of a brief educational intervention in improving the uptake of seasonal influenza vaccine among pregnant women in Hong Kong .


A randomised controlled trial will be conducted with pregnant women in at least the second trimester of pregnancy from four publicly funded hospital antenatal clinics in Hong Kong .


Participants will be randomly assigned to either one of the two treatment groups : standard care ( control ) or standard care plus brief education ( intervention ) .


Pregnant women in the standard care group will receive the usual antenatal care with an educational pamphlet developed by the Hong Kong Centre for Health Protection and those in the intervention group will be provided with usual care plus a brief ten-minute education intervention .


Content of the education session will cover four core components recommended in the research literature .


The primary study outcome will be the proportion of participants who have received influenza vaccine during their pregnancy .


A total of 184 pregnant women ( 92 per group ) will be required to give an 80 % power to detect a treatment effect of 15 % .


Most intervention studies aimed at improving influenza vaccination rates in pregnant women have targeted obstetric-care providers and the results of the two patient-oriented RCT interventions are conflicting .


The high priority for vaccination given to pregnant women and the low influenza vaccination rate among pregnant women worldwide strongly indicates a need for interventions to improve uptake .


Serious adverse events ( SAEs ) from heart failure ( HF ) therapy are frequent ; however , techniques to identify at-risk patients are inadequate .


Furthermore , the relationship between SAEs , quality of life ( QOL ) , and cardiac structure are unknown .


151 symptomatic patients with systolic HF were followed for a mean of 10 months .


In this post hoc analysis , treatment-related SAEs included acute renal failure , dizziness , hypo/hyperkalemia , hypotension , and syncope .


At 1 year , 21 treatment-related SAEs occurred .


No difference in SAEs existed between the N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) - guided arm and the standard of care arm ( P = .20 ) .


At baseline , patients who suffered SAEs were less likely to be receiving beta-blockers ( 85.7 % vs 97.7 % ; P = .009 ) and had worse functional class and lower chloride levels .


Patients who experienced SAEs had less improvement in their Minnesota Living With Heart Failure Questionnaire scores and had a trend toward reduced echocardiographic reverse remodeling over the follow-up period .


Univariable and multivariable analyses were conducted to develop a risk score for SAE prediction ; patients in the highest risk quartile had the shortest time to first cardiovascular event ( P = 0.01 ) .


NT-proBNP-guided HF care is safe .


Experiencing treatment-related SAEs is associated with worse QOL and potentially reduced reverse remodeling .


A risk score to prospectively predict SAEs in aggressive HF management was developed .


To investigate risk factors for disc hemorrhage detection in the Low-Pressure Glaucoma Treatment Study .


Cohort of a randomized , double-masked , multicenter clinical trial .


Low-Pressure Glaucoma Treatment Study patients with at least 16months of follow-up were included .


Exclusion criteria included untreated intraocular pressure ( IOP ) of more than 21mm Hg , visual field mean deviation worse than-16 dB , or contraindications to study medications .


Patients were randomized to topical treatment with timolol 0.5 % or brimonidine 0.2 % .


Stereophotographs were reviewed independently by 2 masked graders searching for disc hemorrhages .


The main outcomes investigated were the detection of disc hemorrhage at any time during follow-up and their recurrence .


Ocular and systemic risk factors for disc hemorrhage detection were analyzed using the Cox proportional hazards model and were tested further for independence in a multivariate model .


Two hundred fifty-three eyes of 127 subjects ( mean age , 64.7 10.9 years ; women , 58 % ; European ancestry , 71 % ) followed up for an average standard deviation of 40.6 12months were included .


In the multivariate analysis , history of migraine ( hazard ratio [ HR ] , 5.737 ; P = .012 ) , narrower neuroretinal rim width at baseline ( HR , 2.91 ; P = .048 ) , use of systemic - blockers ( HR , 5.585 ; P = .036 ) , low mean systolic blood pressure ( HR , 1.06 ; P = .02 ) , and low mean arterial ocular perfusion pressure during follow-up ( HR , 1.172 ; P = .007 ) were significant and independent risk factors for disc hemorrhage detection .


Treatment randomization was not associated with either the occurrence or recurrence of disc hemorrhages .


In this cohort of Low-Pressure Glaucoma Treatment Study patients , migraine , baseline narrower neuroretinal rim width , low systolic blood pressure and mean arterial ocular perfusion pressure , and use of systemic - blockers were risk factors for disc hemorrhage detection .


Randomization assignment did not influence the frequency of disc hemorrhage detection .


To investigate the effectiveness of repetitive facilitative exercise ( RFE ) under surface neuromuscular electrical stimulation ( NMES ) in patients with post-stroke hemiplegia .


This randomized , controlled , observer-blinded , pilot trial randomized 27 adults with severe arm impairment [ Fugl-Meyer Arm scale ( FMA ) 20 ] due to stroke of 3-13 weeks duration into three groups and provided treatment on a 4-week , 40 minutes/day , 5 days/week schedule .


The RFE-under-NMES group were given 100-150 repetitions of standardized movements of shoulder , elbow and wrist joints of their affected arm with concurrent low-amplitude NMES for each corresponding musculature .


The RFE group was given the same exercise regimen but without NMES .


The control group was treated with a conventional arm rehabilitation programme without NMES .


FMA was assessed at baseline and 4 weeks .


All 27 participants ( nine in each group ) completed the trial .


At 4 weeks , the RFE-under-NMES group evidenced significantly greater improvement compared with the control group on the FMA ( p = 0.003 ) , but not with the RFE group ( p = 0.092 ) .


The RFE group showed improvement compared with the control group , but it was not significant ( p = 0.199 ) .


RFE under NMES is feasible in clinical settings and may be more effective than conventional rehabilitation in lessening arm impairment after sub-acute stroke .


In the critically ill undergoing urgent endotracheal intubation by direct laryngoscopy , multiple attempts are often required with a higher complication rate due to the urgency , uncontrolled setting , comorbidities , and variability in expertise of operators .


We hypothesized that Glidescope video laryngoscopy would be superior to direct laryngoscopy during urgent endotracheal intubation .


Single-center prospective randomized controlled trial .


Beth Israel Medical Center , an 856-bed urban teaching hospital with a 16-bed closed medical ICU .


Of 153 consecutive patients undergoing urgent endotracheal intubation by pulmonary and critical care medicine fellows , 117 met inclusion criteria .


Patients undergoing urgent endotracheal intubation were randomized to Glidescope video laryngoscopy or direct laryngoscopy as the primary intubation device .


The primary outcome measure was the rate of first-attempt success .


Acute Physiology and Chronic Health Evaluation II scores were similar between groups ( 20.9 8.2 vs 19.9 7.9 ) .


First-attempt success was achieved in 74 % of the Glidescope video laryngoscopy group compared with 40 % in the direct laryngoscopy group ( p < 0.001 ) .


All unsuccessful direct laryngoscopy patients were successfully intubated with Glidescope video laryngoscopy , 82 % on the first attempt .


There was no significant difference in rates of complications between direct laryngoscopy and Glidescope video laryngoscopy : esophageal intubations ( 7 % vs 0 % ; p = 0.05 ) , aspiration events ( 7 % vs 9 % ; p = 0.69 ) , desaturation ( 8 % vs 4 % ; p = 0.27 ) , and hypotension ( 13 % vs 11 % ; p = 0.64 ) .


Glidescope video laryngoscopy improves the first-attempt success rate during urgent endotracheal intubation performed by pulmonary and critical care medicine fellows when compared with direct laryngoscopy .


To observe the efficacy and safety of oral sanhuangwuji powder , anti-rheumatic drugs ( ARDs ) , and ginger-partitioned acupoint stimulation at zusanli ( ST 36 ) on the treatment of rheumatoid arthritis ( RA ) complicated by peptic ulcer .


This prospective randomized controlled study included 180 eligible inpatients and outpatients randomly assigned to an ARD treatment ( n. = 60 ) , ginger-partitioned stimulation ( n = 60 ) , or combination treatment ( n = 60 ) .


Patients assigned to the ARD group were given oral celecoxib , methotrexate , and esomeprazole .


Patients assigned to the ginger-partitioned stimulation group were given ginger-partitioned acupoint stimulation at zusanli ( ST 36 ) in addition to the ARDs .


Patients in the combination treatment group were given oral sanhuangwuji powder , ginger-partitioned acupoint stimulation at susanli ( ST 36 ) , and ARDs .


All patients were followed up for 2 months to evaluate clinical effects and safety .


The study was registered in the World Health Organization database at the General Hospital of Chengdu Military Area Command Chinese People 's Liberation Army ( ChiCTR-TCC12002824 ) .


The combination treatment group had significantly greater improvements in RA symptoms , laboratory outcomes , and gastrointestinal symptom scores , compared with the other groups ( P < 0.05 ) .


The peptic ulcer healing rate in the combination treatment group was significantly greater than that in the ARD treatment group ( 2 = 16.875 , P < 0.05 ) and the ginger-partitioned stimulation group ( 2 = 6.171 , P < 0.05 ) .


Combination treatment with ginger-partitioned acupoint stimulation at zusanli ( ST 36 ) , oral sanhuangwuji powder , and ARDs had a better clinical effect for RA with complicated peptic ulcer , compared with ARD treatmentalone or in combination with ginger-partitioned acupoint stimulation .


Survivors after cardiac arrest ( CA ) exhibits a systemic inflammatory response as part of post-cardiac arrest syndrome ( PCAS ) .


We investigated the association between systemic inflammation and severity of PCAS and whether level of targeted temperature management ( TTM ) modifies level of the inflammatory response .


We studied 169 patients included at a single center in the TTM-trial , randomly assigned to TTM at 33 C or 36 C for 24 h. Plasma samples were analyzed for inflammatory markers including interleukin ( IL ) IL-1 , IL-4 , IL-6 , IL-10 , tumor necrosis factor - ( TNF - ) , C-reactive protein ( CRP ) and procalcitonin ( PCT ) at randomization and 24 , 48 and 72 h after CA .


Severity of PCAS was assessed by Sequential Organ Failure Assessment ( SOFA ) score .