Secondary end points include parasite clearance time , rates of recurrent infection/treatment failure to day 42 , gametocyte carriage throughout follow-up and rates of anaemia at day 28 , as determined by survival analysis .


This study has been approved by relevant institutional ethics committees in Malaysia and Australia .


Results will be disseminated to inform knowlesi malaria treatment policy in this region through peer-reviewed publications and academic presentations .


NCT01708876 .


To assess the efficacy/safety of canagliflozin , a sodium-glucose cotransporter 2 inhibitor , compared with glimepiride over 104 weeks in patients with type 2 diabetes inadequately controlled with metformin .


In this randomized , double-blind study , patients ( N = 1,450 ) received canagliflozin 100 or 300 mg or glimepiride ( titrated up to 6 or 8 mg/day ) during a 52-week core period followed by a 52-week extension .


At week 104 , reductions from baseline in A1C were -0.65 % , -0.74 % , and -0.55 % ( -7.1 , -8.1 , and -6.0 mmol/mol ) with canagliflozin 100 and 300 mg and glimepiride , respectively .


Durability analyses showed sustained A1C lowering with both canagliflozin doses versus glimepiride .


Reductions in body weight ( -4.1 % , -4.2 % , and 0.9 % , respectively ) and systolic blood pressure ( -2.0 , -3.1 , and 1.7 mmHg , respectively ) were seen with canagliflozin 100 and 300 mg compared with glimepiride at week 104 .


The overall adverse event ( AE ) incidence was 73.3 % , 77.9 % , and 78.4 % with canagliflozin 100 and 300 mg and glimepiride ; the incidence of AE-related discontinuations was low across groups ( 6.2 % , 9.5 % , and 7.3 % , respectively ) .


Incidences of genital mycotic infections , urinary tract infections , and osmotic diuresis-related AEs were higher with canagliflozin than glimepiride ; these were generally mild to moderate in intensity and led to few discontinuations .


Fewer patients had hypoglycemia episodes with canagliflozin 100 and 300 mg than glimepiride ( 6.8 % , 8.2 % , and 40.9 % ) .


Mild decreases in estimated glomerular filtration rate occurred initially with canagliflozin ; these attenuated over 104 weeks .


Canagliflozin provided durable glycemic improvements compared with glimepiride and was generally well tolerated in patients with type 2 diabetes receiving background treatment with metformin over 104 weeks .


Catheter ablation is increasingly used to manage atrial fibrillation , but arrhythmia recurrences are common .


Adenosine might identify pulmonary veins at risk of reconnection by unmasking dormant conduction , and thereby guide additional ablation to improve arrhythmia-free survival .


We assessed whether adenosine-guided pulmonary vein isolation could prevent arrhythmia recurrence in patients undergoing radiofrequency catheter ablation for paroxysmal atrial fibrillation .


We did this randomised trial at 18 hospitals in Australia , Europe , and North America .


We enrolled patients aged older than 18 years who had had at least three symptomatic atrial fibrillation episodes in the past 6 months , and for whom treatment with an antiarrhythmic drug failed .


After pulmonary vein isolation , intravenous adenosine was administered .


If dormant conduction was present , patients were randomly assigned ( 1:1 ) to additional adenosine-guided ablation to abolish dormant conduction or to no further ablation .


If no dormant conduction was revealed , randomly selected patients were included in a registry .


Patients were masked to treatment allocation and outcomes were assessed by a masked adjudicating committee .


Patients were followed up for 1 year .


The primary outcome was time to symptomatic atrial tachyarrhythmia after a single procedure in the intention-to-treat population .


The trial is registered with ClinicalTrials.gov , number NCT01058980 .


Adenosine unmasked dormant pulmonary vein conduction in 284 ( 53 % ) of 534 patients .


102 ( 694 % ) of 147 patients with additional adenosine-guided ablation were free from symptomatic atrial tachyarrhythmia compared with 58 ( 423 % ) of 137 patients with no further ablation , corresponding to an absolute risk reduction of 271 % ( 95 % CI 159-382 ; p < 00001 ) and a hazard ratio of 044 ( 95 % CI 031-064 ; p < 00001 ) .


Of 115 patients without dormant pulmonary vein conduction , 64 ( 557 % ) remained free from symptomatic atrial tachyarrhythmia ( p = 00191 vs dormant conduction with no further ablation ) .


Occurrences of serious adverse events were similar in each group .


One death ( massive stroke ) was deemed probably related to ablation in a patient included in the registry .


Adenosine testing to identify and target dormant pulmonary vein conduction during catheter ablation of atrial fibrillation is a safe and highly effective strategy to improve arrhythmia-free survival in patients with paroxysmal atrial fibrillation .


This approach should be considered for incorporation into routine clinical practice .


Canadian Institutes of Health Research , St Jude Medical , Biosense-Webster , and M Lachapelle ( Montreal Heart Institute Foundation ) .


Chronic Hepatitis C ( CHC ) Virus infection is a serious health issue in the US .


Standard treatment involves peginterferon alpha and ribavirin , often associated with adverse side effects including flu-like symptoms .


These adverse effects are common reasons for the discontinuation of treatment and therefore represent a major obstacle in the effective treatment of CHC .


The Hepatitis Physical Symptom Severity Diary , a newly developed patient-reported outcome measure for assessing physical symptoms in CHC patients , was recently developed .


It contains four questions addressing flu-like symptoms [ the Flu-Like Symptom Index ( FLSI ) ] .


Measurement properties of the FLSI in CHC patients were assessed using data from two randomized clinical trials .


Exploratory factor analysis using data from baseline and the last visit while on treatment supported a single-factor solution for the FLSI .


Internal reliability and test-retest reliability are acceptable ( Cronbach 's alpha range 0.73-0 .81 ; intraclass correlation coefficient range 0.85-0 .97 ) , and correspondence to several similar constructs was acceptable .


The FLSI score was higher among those with investigator-reported flu-like symptoms ( mean = 4.1 ) versus those without ( 1.4 ) , although not statistically significant ( p = 0.12 ) .


Responsiveness of the FLSI was moderate , as measured by standardized effect sizes and response means , and the minimum important difference ( MID ) was estimated at 2.5-3 .0 points .


While additional research should be conducted to evaluate validity with more closely related constructs and to utilize anchor-based methods for estimating the MID , data suggest that the FLSI has acceptable measurement properties and can be an effective tool in assessing flu-like symptoms in CHC patients .


Because of its location in the lower neck and anatomical variability , the C7 medial branch represents a challenging target for local anesthetic blocks .


Although ultrasound ( US ) guidance offers an alternative to fluoroscopy for C3 to C6 cervical medial branch blocks ( CMBBs ) , its use at the C7 level has not been examined .


We hypothesized that US , using a biplanar imaging technique , could provide a shorter performance time than conventional fluoroscopy for C7 CMBB .


Fifty patients undergoing C7 CMBB were randomized to fluoroscopy or US guidance .


A 0.6-mL mixture of local anesthetic and radiographic contrast was injected in both groups .


The primary outcome was performance time .


Secondary outcomes included success rate , pain levels preblock and postblock , and incidences of aberrant spread and procedure-related complications .


Compared to fluoroscopy , US guidance was associated with a shorter performance time ( 233.6 80.4 vs 390.6 142.4 seconds ; P < 0.001 ) and fewer needle passes ( 2 vs 4 ; P < 0.001 ) .


However , both imaging modalities provided similar success rates ( 92 % -96 % ) .


Furthermore , no intergroup differences were found in preblock and postblock pain scores .


In the fluoroscopy group , intravascular and intra-articular spreads were seen in 20 % and 4 % of cases , respectively .


In the US group , a blood vessel was visualized overlying the target area and successfully avoided during needle insertion in 40 % of patients .


No procedure-related complications occurred in either group .


Ultrasound guidance using a biplanar approach provides a similar success rate to fluoroscopy for C7 CMBB .


However , US is associated with improved efficiency ( decreased performance time and fewer needle passes ) .


An increase in physical activity for secondary prevention of cardiovascular disease and cardiac rehabilitation has multiple therapeutic benefits , including decreased mortality .


Internet - and mobile-based interventions for physical activity have shown promising results in helping users increase or maintain their level of physical activity in general and specifically in secondary prevention of cardiovascular diseases and cardiac rehabilitation .


One component related to the efficacy of these interventions is tailoring of the content to the individual .


Our trial assessed the effect of a longitudinally tailored Internet - and mobile-based intervention for physical activity as an extension of a face-to-face cardiac rehabilitation stay .


We hypothesized that users of the tailored intervention would maintain their physical activity level better than users of the nontailored version .


The study population included adult participants of a cardiac rehabilitation program in Norway with home Internet access and a mobile phone .


The participants were randomized in monthly clusters to a tailored or nontailored ( control ) intervention group .


All participants had access to a website with information regarding cardiac rehabilitation , an online discussion forum , and an online activity calendar .


Those using the tailored intervention received tailored content based on models of health behavior via the website and mobile fully automated text messages .


The main outcome was self-reported level of physical activity , which was obtained using an online international physical activity questionnaire at baseline , at discharge , and at 1 month and 3 months after discharge from the cardiac rehabilitation program .


Included in the study were 69 participants .


One month after discharge , the tailored intervention group ( n = 10 ) had a higher median level of overall physical activity ( median 2737.5 , IQR 4200.2 ) than the control group ( n = 14 , median 1650.0 , IQR 2443.5 ) , but the difference was not significant ( Kolmogorov-Smirnov Z = 0.823 , P = .38 , r = .17 ) .


At 3 months after discharge , the tailored intervention group ( n = 7 ) had a significantly higher median level of overall physical activity ( median 5613.0 , IQR 2828.0 ) than the control group ( n = 12 , median 1356.0 , IQR 2937.0 ; Kolmogorov-Smirnov Z = 1.397 , P = .02 , r = .33 ) .


The median adherence was 45.0 ( 95 % CI 0.0-169 .8 ) days for the tailored group and 111.0 ( 95 % CI 45.1-176 .9 ) days for the control group ; however , the difference was not significant ( P = .39 ) .


There were no statistically significant differences between the 2 groups in stage of change , self-efficacy , social support , perceived tailoring , anxiety , or depression .


Because of the small sample size and the high attrition rate at the follow-up visits , we can not make conclusions regarding the efficacy of our approach , but the results indicate that the tailored version of the intervention may have contributed to the long-term higher physical activity maintained after cardiac rehabilitation by participants receiving the tailored intervention compared with those receiving the nontailored intervention .


ClinicalTrials.gov : NCT01223170 ; http://clinicaltrials.gov/show/NCT01223170 ( Archived by WebCite at http://www.webcitation.org/6Nch4ldcL ) .


Prospective cohort studies showed inverse associations between the intake of flavonoid-rich foods ( cocoa and tea ) and cardiovascular disease ( CVD ) .


Intervention studies showed protective effects on intermediate markers of CVD .


This may be due to the protective effects of the flavonoids epicatechin ( in cocoa and tea ) and quercetin ( in tea ) .


We investigated the effects of supplementation of pure epicatechin and quercetin on vascular function and cardiometabolic health .


Thirty-seven apparently healthy men and women aged 40-80 y with a systolic blood pressure ( BP ) between 125 and 160 mm Hg at screening were enrolled in a randomized , double-blind , placebo-controlled , crossover trial .


CVD risk factors were measured before and after 4 wk of daily flavonoid supplementation .


Participants received ( - ) - epicatechin ( 100 mg/d ) , quercetin-3-glucoside ( 160 mg/d ) , or placebo capsules for 4 wk in random order .


The primary outcome was the change in flow-mediated dilation from pre - to postintervention .


Secondary outcomes included other markers of CVD risk and vascular function .


Epicatechin supplementation did not change flow-mediated dilation significantly ( 1.1 % absolute ; 95 % CI : -0.1 % , 2.3 % ; P = 0.07 ) .


Epicatechin supplementation improved fasting plasma insulin ( insulin : -1.46 mU/L ; 95 % CI : -2.74 , -0.18 mU/L ; P = 0.03 ) and insulin resistance ( homeostasis model assessment of insulin resistance : -0.38 ; 95 % CI : -0.74 , -0.01 ; P = 0.04 ) and had no effect on fasting plasma glucose .


Epicatechin did not change BP ( office BP and 24-h ambulatory BP ) , arterial stiffness , nitric oxide , endothelin 1 , or blood lipid profile .


Quercetin-3-glucoside supplementation had no effect on flow-mediated dilation , insulin resistance , or other CVD risk factors .


Our results suggest that epicatechin may in part contribute to the cardioprotective effects of cocoa and tea by improving insulin resistance .


It is unlikely that quercetin plays an important role in the cardioprotective effects of tea .


This study was registered at clinicaltrials.gov as NCT01691404 .


Recent evidence shows poor retention of Pediatric Advanced Life Support provider skills .


Frequent refresher training and in situ simulation are promising interventions .


We developed a `` Pediatric Advanced Life Support-reconstructed '' recertification course by deconstructing the training into six 30-minute in situ simulation scenario sessions delivered over 6 months .


We hypothesized that in situ Pediatric Advanced Life Support-reconstructed implementation is feasible and as effective as standard Pediatric Advanced Life Support recertification .


A prospective randomized , single-blinded trial .


Single-center , large , tertiary PICU in a university-affiliated children 's hospital .


Nurses and respiratory therapists in PICU .


Simulation-based modular Pediatric Advanced Life Support recertification training .


Simulation-based pre - and postassessment sessions were conducted to evaluate participants ' performance .


Video-recorded sessions were rated by trained raters blinded to allocation .


The primary outcome was skill performance measured by a validated Clinical Performance Tool , and secondary outcome was behavioral performance measured by a Behavioral Assessment Tool .


A mixed-effect model was used to account for baseline differences .


Forty participants were prospectively randomized to Pediatric Advanced Life Support reconstructed versus standard Pediatric Advanced Life Support with no significant difference in demographics .


Clinical Performance Tool score was similar at baseline in both groups and improved after Pediatric Advanced Life Support reconstructed ( pre , 16.3 4.1 vs post , 22.4 3.9 ; p < 0.001 ) , but not after standard Pediatric Advanced Life Support ( pre , 14.3 4.7 vs post , 14.9 4.4 ; p = 0.59 ) .


Improvement of Clinical Performance Tool was significantly higher in Pediatric Advanced Life Support reconstructed compared with standard Pediatric Advanced Life Support ( p = 0.006 ) .


Behavioral Assessment Tool improved in both groups : Pediatric Advanced Life Support reconstructed ( pre , 33.3 4.5 vs post , 35.9 5.0 ; p = 0.008 ) and standard Pediatric Advanced Life Support ( pre , 30.5 4.7 vs post , 33.6 4.9 ; p = 0.02 ) , with no significant difference of improvement between both groups ( p = 0.49 ) .


For PICU-based nurses and respiratory therapists , simulation-based `` Pediatric Advanced Life Support-reconstructed '' in situ training is feasible and more effective than standard Pediatric Advanced Life Support recertification training for skill performance .


Both Pediatric Advanced Life Support recertification training courses improved behavioral performance .


The safety and efficacy of tenofovir disoproxil fumarate ( TDF ) in HIV-1-infected children have not been evaluated in a randomized controlled trial .


Subjects ( 2 to < 16 years ) on a stavudine ( d4T ) or zidovudine ( ZDV ) containing regimen with HIV-1 RNA < 400 copies/mL were randomized to either switch d4T or ZDV to TDF or continue d4T or ZDV .


The primary endpoint was the proportion of subjects with HIV-1 RNA < 400 copies/mL at Week 48 with a prespecified noninferiority margin of 15 % .


After the 48-week randomized phase , eligible subjects were rolled over to an extension phase .


Ninety-seven children ( 48 TDF vs. 49 d4T or ZDV ) were randomized and treated .


The percent of subjects who maintained virologic suppression in the TDF versus d4T or ZDV group at Week 24 were 93.8 % versus 89.8 % ( difference 4.0 % ; 95 % confidence interval : : -6.9 % to 14.9 % ) and at Week 48 were 83.3 % versus 91.8 % ( difference : -8.5 % ; 95 % confidence interval : -21.5 % to 4.5 % ; missing = failure , intent-to-treat analysis ) .


No subjects discontinued study drug because of an adverse event in the 48 weeks of randomized phase .


Four subjects discontinued TDF because of proximal renal tubulopathy in the extension phase .


Our study did not demonstrate noninferiority of TDF versus d4T or ZDV at Week 48 .


Overall safety and tolerability of TDF in children were consistent with adults .


TDF may be considered as an alternative to d4T or ZDV in HIV-infected children .


A recent study of supermarket bakery workers in South Africa demonstrated that 25 % of workers were sensitised to flour allergens and 13 % had baker 's asthma .


Evidence on exposure reduction strategies using specifically designed interventions aimed at reducing the risk of baker 's asthma is scarce .


The aim of this study was to evaluate the effectiveness of different control measures to reduce airborne flour dust exposure using a randomised design .


A group-randomised study design was used to assign 30 bakeries of a large supermarket chain store to two intervention groups and a control group , of which 15 bakeries were studied .


Full-shift environmental personal samples were used to characterise exposure to flour dust and wheat and rye allergens levels pre-intervention ( n = 176 ) and post-intervention ( n = 208 ) .


The overall intervention effect revealed a 50 % decrease in mean flour dust , wheat and rye allergen exposure .


The reduction in exposure was highest for managers ( 67 % ) and bakers ( 47 % ) , and lowest for counterhands ( 23 % ) .


For bakers , the greatest reduction in flour dust was associated with control measures such as the use of the mixer lid ( 67 % ) , divider oil ( 63 % ) or focused training ( 54 % ) .


However , the greatest reduction ( 80 % ) was observed when using a combination of all control measures .


A specially designed intervention strategy reduced both flour dust and allergen levels .


Best results were observed when combining both engineering controls and training .


Further studies will investigate the long-term health impact of these interventions on reducing the disease burden among this group of bakers .


Depression is common after acute coronary syndrome ( ACS ) and has adverse effects on prognosis .


There are few evidence-based interventions for treating depression in ACS .


This study investigated the efficacy and safety of escitalopram in treating depressive disorders identified 2-14 weeks after a confirmed ACS episode .


A total of 217 patients with DSM-IV depressive disorders ( 121 major and 96 minor ) and ACS were randomly assigned to receive escitalopram in flexible doses of 5-20 mg/d ( n = 108 ) or placebo ( n = 109 ) for 24 weeks .


The study was conducted from 2007 to 2013 .


The primary outcome measure was the Hamilton Depression Rating Scale ( HDRS ) .


Secondary outcome measures included the Montgomery-Asberg Depression Rating Scale ( MADRS ) , Beck Depression Inventory ( BDI ) , Clinical Global Impressions-Severity of Illness scale ( CGI-S ) , Social and Occupational Functioning Assessment Scale ( SOFAS ) , and World Health Organization Disability Assessment Schedule-12 .


Cardiovascular safety outcomes included echocardiography , electrocardiography , laboratory test , body weight , and blood pressure results .


Escitalopram was superior to placebo in reducing HDRS scores ( mean difference = 2.3 , P = .016 , effect size = 0.38 ) .


Escitalopram was also superior to placebo in decreasing depressive symptoms evaluated by the MADRS , BDI , and CGI-S and in improving SOFAS functioning level .


Escitalopram was not associated with any harmful changes in cardiovascular safety measures .


Dizziness was significantly more frequently reported in the escitalopram group ( P = .018 ) , but there were no significant differences in any other adverse events .


These results indicate that escitalopram has clinically meaningful antidepressant effects with no evidence of reduced cardiovascular safety in depressive disorder following ACS .


ClinicalTrials.gov identifier : NCT00419471 .


In ablation of atrial fibrillation , the single-ring method aims for isolation of the posterior wall of the left atrium ( LA ) including the pulmonary veins ( PVs ) but avoiding posterior LA lesions .


The aim of this randomized prospective study was to evaluate safety and efficacy of remote magnetic navigation ( RMN ) - guided single-ring ablation strategy as compared to standard RMN-guided circumferential PV ablation ( PVA ) .


Eighty consecutive patients undergoing PVA were enrolled prospectively and randomized equally into two study groups .


RMN using the Stereotaxis system and open-irrigated 3.5-mm ablation catheters were used with a 3D mapping system in all procedures .


Forty patients underwent RMN-guided single-ring ablation , and 40 patients received RMN-guided circumferential PVA .


In the circumferential group , 3.3 1.1 PVs were successfully isolated at the end of the procedure as compared to 3.1 1.3 in the single-ring ( box ) group ( p = 0.38 ) .


All patients in the box group required additional posterior lesions in order to achieve electrical isolation of the PVs .


Single-ring ablation was associated with longer procedure duration ( p = 0.01 ) and ablation time ( p = 0.001 ) .


After a single procedure , the proportion of patients free of any atrial tachycardia ( AT ) / atrial fibrillation ( AF ) episode at 12-month follow-up was 57 % in the box group and 58 % in the circ group .


Using RMN , only minor complications have been observed .


RMN-guided single-ring PVA provides comparable acute and long-term success rates as compared to RMN-guided circumferential PVA but requires additional posterior lesions to achieve PV isolation and increased procedure and ablation time .


Procedural complication rates are low when using RMN .


This study investigated the effects and Numerical Rating Pain Scale ( NRS ) of using absorbable shanching satin rb-bFGF prepreg sheet and expansion hemostatic sponge together nasal packing in the control of epistaxis with blood disease , and compared it with traditional vaseline gauze .


Ninety-six blood disease patient with epistaxis were enrolled between January 2009 and February 2011 , they were divided into two groups at random , and differently treated with absorbable shanching satin rb-bFGF prepreg sheet and the vaseline gauze nasal packing for haemostasis .


Then haemostasis efficacy , the hemorrhage rate after nasal packing removed and host response , such as nasal pain and headache , which evaluated pain degrees against NRS , were all observed .


There was no significant difference between the two groups of the haemostatic effect .


But the hemorrhage rate of treatment group was obviously lower than that of the control group after paching , in addition , host responses , such as nasal pain and headache , remarkably better than the control group , the difference had statistical significance .


It is indicate that absorbable shanching satin rb-bFGF prepreg sheet presents reliable hemostasis effect , good biocompatibility and compliance ; the pain and headache caused by packing are superior to vaseline gauze .


Moreover , this method avoids the direct touch of vaseline gauze with nasal mucosal wound , and reduce hemorrhage after packing .


Absorbable shanching satin rb-bFGF prepreg sheet and expansion hemostatic sponge together is better to select the nasal packing material for blood disease patient with epistaxis .


The purpose of this study was to assess long-term improvement in quality of life ( QOL ) in adolescents with attention-deficit/hyperactivity disorder ( ADHD ) treated with lisdexamfetamine dimesylate ( LDX ) .


Adolescents with ADHD treated for 3 weeks in a 4 week , placebo-controlled study entered a 1 year , open-label study .


After the 4 week dose optimization ( 30 , 50 , and 70mg/day LDX ) period , treatment was maintained for 48 additional weeks .


Change from baseline ( of prior study ) to week 52/early termination ( ET ) ( of open-label study ) in ADHD Rating Scale IV ( ADHD-RS-IV ) assessed effectiveness , and the Youth QOL-Research Version ( YQOL-R ) assessed participant-perceived QOL .


Post-hoc analyses described effectiveness and QOL for participants with self-perceived poor QOL at baseline ( 1 SD below the mean ) versus all others , and for study completers versus study noncompleters .


These post-hoc analyses included 265 participants .


Participants with baseline self-perceived poor QOL ( n = 32 ) versus all others ( n = 232 ) exhibited robust YQOL-R perceptual score changes ( improvement ) with LDX , emerging by week 28 and maintained to week 52/ET .


Week 52/ET mean change score ranged from +9.8 to +17.6 for participants with baseline self-perceived poor QOL and +0.4 to +5.1 for all others ; week 52/ET improvements in ADHD-RS-IV total scores were similar , regardless of baseline YQOL-R total score .


At week 52/ET , study completers had greater YQOL-R improvements than did noncompleters ; ADHD-RS-IV total score changes were also numerically larger at week 52/ET for completers than for noncompleters .


Participant-perceived QOL and ADHD symptoms improved from baseline with LDX in adolescents with ADHD ; greatest improvements occurred among participants with baseline self-perceived poor QOL .


Chemotherapy-induced peripheral neuropathy ( CIPN ) , a common side effect of chemotherapy , needs better effective treatments .


Preliminary data support the use of Scrambler therapy , a device which treats pain via noninvasive cutaneous electrostimulation , for the treatment of CIPN .


The current manuscript reports data from a pilot trial , performed to investigate the effect of Scrambler therapy for the treatment of established CIPN .


Eligible patients had CIPN symptoms of 1 month duration with tingling and/or pain 4/10 during the prior week .


Patients were treated with Scrambler therapy to the affected area ( s ) for up to ten daily 30-min sessions .


Symptoms were monitored using a neuropathy questionnaire consisting of numerical analog scales ranging from 0 to 10 , daily before therapy as well as weekly for 10 weeks after therapy .


Descriptive summary statistics formed the basis of data analysis .


Thirty-seven patients were enrolled .


Twenty-five patients were treated primarily on their lower extremities while 12 were treated primarily on their upper extremities .


There was a 53 % reduction in pain score from baseline to day 10 ; a 44 % reduction in tingling ; and a 37 % reduction in numbness .


Benefit appeared to last throughout 10 weeks of follow-up .


There were no substantial adverse events .


Preliminary data support that Scrambler therapy may be effective for the treatment of CIPN : a prospective placebo-controlled clinical trial should be performed .


The treatment of burn patients who undergo mechanical ventilation is complicated by many factors ; patient outcomes and mortality could potentially be improved with predictive biomarkers .


Severe burn provokes a systemic inflammatory response characterized by the release of a host of cytokines .


Recent studies evaluated the prognostic value of temporal changes in cytokine levels in several patient populations , but few have compared differences in the cytokine profiles of survivors and nonsurvivors following severe burn .


We previously compared high-frequency percussive ventilation and low-tidal-volume ventilation and found no difference in mortality or cytokine levels between the two treatments .


Since it is unknown whether cytokine levels are predictive of mortality in these patients , we performed a post hoc analysis comparing cytokine levels in survivors and nonsurvivors .


We evaluated plasma levels of several cytokines ( interleukin 1 [ IL-1 ] , IL-6 , IL-8 , granulocyte-macrophage colony-stimulating factor , and tumor necrosis factor ) for their prognostic biomarker potential related to mortality at 0 , 3 , and 7 days in survivors and nonsurvivors of burns .


While the majority of values for IL-1 , granulocyte-macrophage colony-stimulating factor , and tumor necrosis factor fell below the limit of quantification , univariate analysis demonstrated higher plasma levels of IL-6 and IL-8 in nonsurvivors on Day 7 .


Logistic regression revealed that elevated plasma IL-8 was independently associated with an increased likelihood of the composite end point of death or ventilator-associated pneumonia with odds ratios of 7.9 , 26 , and 7.3 on Days 0 , 3 , and 7 , respectively .


Early increases in plasma IL-8 are associated with a multifold increase in death or ventilator-associated pneumonia in mechanically ventilated burn patients .


Prognostic/epidemiologic study , level IV ; therapeutic study , level IV .


The purpose of this report was to examine the course of smoking among pregnant women with concurrent substance use , and to assess the impact of depression on smoking .


Data were gathered as part of a randomized controlled trial assessing the efficacy of substance abuse treatment in pregnant women .


Women ( n = 176 ) were recruited before 28 completed weeks of pregnancy , and followed until 3months postpartum .


Depression was assessed using the Inventory of Depressive Symptomatology and the MINI Neuropsychiatric Interview .


Our outcome was the average number of cigarettes smoked per day .


Linear mixed effects regression was used to measure differential changes in smoking .


66 % of women smoked in the three months before pregnancy , 42 % of pre-pregnancy smokers achieved abstinence before delivery and 60 % of the baseline cohort smoked postpartum .


Smoking did not differ significantly between depressed and non-depressed groups .


After delivery both groups increased smoking at similar rates .


Smoking was common among our cohort of pregnant women with a history of substance use .


Women were able to discontinue or decrease smoking during pregnancy , but were likely to resume or increase smoking postpartum .


Having clinically significant depressive symptoms or a diagnosis of depression did not have an obvious effect on smoking behaviors .


To assess effects of tadalafil vs placebo on prostatic blood flow measured by transrectal ultrasonography in men aged45years with moderate-to-severe benign prostatic hyperplasia-lower urinary tract symptoms .


After screening and washout , patients were randomized to placebo ( n = 50 ) or tadalafil 5mg ( n = 47 ) once daily for 8weeks .


Transrectal ultrasonography was performed at baseline , 4 , and 8weeks .


The primary efficacy measure was the prostate transition zone ( TZ ) resistive index ( RI ) .


Secondary efficacy measures were RI in the peripheral zone and bladder neck , color pixel intensity ( CPI ) , and color pixel density ( CPD ) in all 3 regions .


Outcomes were assessed using mixed-model repeated-measures analyses .


The overall treatment effect ( tadalafil vs placebo ) for the change from baseline through week 8 in prostate TZ RI was not statistically significant ( least squares mean change : placebo,-0 .01 ; tadalafil , 0.00 ; P = .118 ) , nor was the change from baseline in prostate TZ CPI ( P = .564 ) or CPD ( P = .592 ) .


Results were similar for all flow measures in prostate peripheral zone and bladder neck .


The adverse event profile was consistent with previous studies with no new safety findings .


Tadalafil for 8weeks in men with BPH-LUTS did not result in detectable decreases in arterial RI or increases in CPI or CPD in the prostate or bladder neck .


Detection of changes may not be possible because of already low baseline RI , insufficient sensitivity of techniques used , or may have been confounded by methodologic variability across sites .


Alternatively , other possible mechanisms not assessed in this study may be more prominently involved .


Although the repositioning maneuvers are usually very effective in patients with BPPV , some patients still complain residual dizziness .


Danhong injection ( DHI ) , a traditional Chinese medicine , can effectively dilate blood vessels and improve microcirculation , and has been proven to be effective in improving cervical vertigo and posterior circulation ischemic vertigo .


The aim of this study was to evaluate the effects of DHI on residual dizziness after successful repositioning treatment in patients with BPPV .


Eighty-six patients with BPPV were randomized into two treatment groups , DHI group and non DHI group .


The DHI group received the same repositioning treatment as the non-DHI group , with the addition of DHI therapy .


The durations of residual dizziness of DHI group and non-DHI group were compared .


In addition , the scores of the dizziness handicap inventory of these two groups were calculated .


The durations of residual dizziness of DHI group were shorter than that of non-DHI group .


There were no significant differences in the scores of dizziness handicap inventory in the first week between these two groups , and there were much significant differences in the second , the fourth , the sixth and eighth weeks .


The results demonstrate that DHI can significantly improve the residual dizziness after successful repositioning treatment in patients with BPPV .


Syphilis infection may potentiate transmission of human immunodeficiency virus ( HIV ) .


We sought to determine the extent to which HIV acquisition was associated with syphilis infection within an HIV preexposure prophylaxis ( PrEP ) trial and whether emtricitabine/tenofovir ( FTC/TDF ) modified that association .


The Preexposure Prophylaxis Initiative ( iPrEx ) study randomly assigned 2499 HIV-seronegative men and transgender women who have sex with men ( MSM ) to receive oral daily FTC/TDF or placebo .


Syphilis prevalence at screening and incidence during follow-up were measured .


Hazard ratios for the effect of incident syphilis on HIV acquisition were calculated .


The effect of FTC/TDF on incident syphilis and HIV acquisition was assessed .


Of 2499 individuals , 360 ( 14.4 % ) had a positive rapid plasma reagin test at screening ; 333 ( 92.5 % ) had a positive confirmatory test , which did not differ between the arms ( FTC/TDF vs placebo , P = .81 ) .


The overall syphilis incidence during the trial was 7.3 cases per 100 person-years .


There was no difference in syphilis incidence between the study arms ( 7.8 cases per 100 person-years for FTC/TDF vs 6.8 cases per 100 person-years for placebo , P = .304 ) .


HIV incidence varied by incident syphilis ( 2.8 cases per 100 person-years for no syphilis vs 8.0 cases per 100 person-years for incident syphilis ) , reflecting a hazard ratio of 2.6 ( 95 % confidence interval , 1.6-4 .4 ; P < .001 ) .


There was no evidence for interaction between randomization to the FTC/TDF arm and incident syphilis on HIV incidence .


In HIV-seronegative MSM , syphilis infection was associated with HIV acquisition in this PrEP trial ; a syphilis diagnosis should prompt providers to offer PrEP unless otherwise contraindicated .


To test the effectiveness and safety of saxagliptin 5 mg/d in patients with type 2 diabetes mellitus ( T2DM ) with and without history of cardiovascular disease ( CVD ) or cardiovascular ( CV ) risk factors .


The authors conducted a post hoc analysis of data from 3 randomized studies that compared saxagliptin versus placebo as initial combination therapy with metformin for 24 weeks ( N = 648 ) and versus placebo as an add-on to insulin with and without metformin for 24 weeks ( N = 455 ) , and assessed noninferiority to glipizide as an add-on to metformin for 52 weeks ( N = 858 ) .


Efficacy outcomes were the adjusted mean change from baseline in glycated hemoglobin ( HbA1c ) level , fasting plasma glucose concentration , and body weight and the proportion of patients achieving an HbA1c level < 7 % .


Pairwise comparisons were performed in subgroups with 1 ) history/no history of CVD , 2 ) 2 versus 0 to 1 CV risk factors , 3 ) hypertension/no hypertension , and 4 ) statin use/no statin use .


Adverse events ( AE ) and hypoglycemia were monitored .


In the initial combination therapy study , reductions in HbA1c level from baseline were greater with saxagliptin versus placebo in all subgroups ( difference [ saxagliptin - placebo ] , -0.38 % to -0.67 % ) .


In the add-on to insulin metformin study , differences in adjusted mean change in HbA1c level versus placebo ranged from -0.23 % to -0.58 % across subgroups .


In the noninferiority to glipizide study , adjusted mean changes in HbA1c level were comparable between saxagliptin and glipizide , across subgroups ( difference , 0.08 % -0.21 % ) .


No evidence suggested clinically relevant treatment-by-subgroup interactions in pairwise comparison .


Incidences of 1 AE were comparable across subgroups .


Incidences of confirmed hypoglycemia with saxagliptin were 0 in both metformin add-on studies and 1.2 % to 7.8 % with saxagliptin + insulin metformin .


In patients with T2DM , saxagliptin 5 mg/d was similarly effective in improving glycemic control , with an AE profile similar to that of placebo , irrespective of CVD history , number of CV risk factors , hypertension , or statin use .


www.ClinicalTrials.gov identifiers : NCT00327015 , NCT00575588 , NCT00757588 .


Cervical incompetence is one of the causes of preterm birth and mid-trimester pregnancy loss .


Cervical cerclage is a surgical procedure to treat cervical incompetence .


Cervical cerclage reduces the incidence of preterm birth in women at risk of recurrent preterm birth , without a statistically significant reduction in perinatal mortality or neonatal morbidity .


Multifilament/braided sutures such as Mersilene tape have been traditionally used for cervical cerclage .


Braided sutures , particularly mesh-like non-absorbable sutures , have been associated with an increased risk of infection and , hence , some obstetricians prefer to use monofilament/non-braided sutures .


However , these claims are not substantiated by any scientific or clinical evidence.We propose a pilot/feasibility study which will provide the necessary information for planning a definitive trial investigating the clinical effectiveness of monofilament non-braided suture materials in reducing pregnancy loss rate following cervical cerclage compared to the traditional multifilament braided sutures .


Women eligible for elective or ultrasound-indicated cerclage at 12 to 21 + 6 weeks of gestation will be randomised to having the procedure using either a monofilament non-braided suture ( Ethilon ) or a Multifilament braided suture ( Mersilene tape ) inserted using a McDonald technique .


Consent for participation in the Cerclage outcome by the type of suture ( COTS ) study will be obtained from each eligible participant .


COTS is registered with the International Standard Research for Clinical Trials ( ISRCTN17866773 ) .


Registered on 27 March 2013 .


Our objective was to evaluate effects of levothyroxine ( l-T4 ) supplementation against neurodevelopmental outcomes at 18 months of corrected age in very-low-birth-weight ( VLBW ) infants with hypothyroxinemia but without elevated thyroid-stimulating hormone ( TSH ) concentration .


VLBW infants who had plasma TSH concentrations < 10 U/mL and free thyroxine ( FT4 ) concentrations < 0.8 ng/dL between 2 and 4 weeks of age were enrolled .


They were randomly assigned to either the Treated ( n = 25 ) or Untreated group ( n = 45 ) .


The Treated group received l-T4 at a dose of 5 g/kg/day .


We compared growth and neurodevelopmental outcomes at 18 months of corrected age in the two groups .


There were no significant differences in growth , the incidences of developmental delay , cerebral palsy , visual impairment , and hearing impairment in the two groups .


In such infants , l-T4 supplementation at a dose of 5 g/kg/day did not affect FT4 levels and showed no beneficial effect at 18 months of corrected age .


Consultations for forefoot pain are frequent in primary care , but scientific support of treatment options is scarce .


The purpose of this study is to investigate the effect of podiatric treatment vs standardized advice on proper shoe characteristics and fit of shoes by means of an information leaflet for people aged 50 years and older with forefoot pain in primary care .


In this randomized controlled trial , 205 participants aged 50 years and older with hindering nontraumatic forefoot pain have been recruited at their general practitioner 's office .


Exclusion criteria were treatment of forefoot problem of less than 6 months ' duration before inclusion , rheumatoid arthritis , and diabetic neuropathy or having pain considered not to be musculoskeletal ( eg , warts ) .


Participants received shoe advice by means of an information leaflet or podiatric care .


Foot pain , foot-related dysfunction , general health , and social participation were assessed by means of questionnaires every 3 months for 1 year .


Using multilevel analysis , we analyzed results at the level of ( 1 ) outcome measures , ( 2 ) the individual , and ( 3 ) the general practitioner .


No differences were found between the 2 treatment groups .


Both intervention groups showed an improvement over time in foot pain and foot-related dysfunction .


This study found that shoe advice provided to patients consulting their general practitioner for forefoot pain and symptom relief resulted in outcomes similar to treatment outcomes in patients consulting a podiatrist .


Based on these results , primary care physicians should be cautious when referring a patient to a podiatrist ; instead , they should start by providing advice on proper characteristics and fit of shoes .


The aim of this randomized controlled trial was to investigate the effects of conventional face-to-face group cognitive behavioral therapy ( GCBT ) and an Internet-delivered guided self-help treatment ( Internet-based CBT , ICBT ) on tinnitus distress .


A total of 128 adults with at least mild levels of chronic tinnitus distress were randomly assigned to GCBT ( n = 43 ) , ICBT ( n = 41 ) , or a web-based discussion forum ( DF ) that served as a control condition ( n = 44 ) .


Standardized self-report measures [ the Tinnitus Handicap Inventory ( THI ) , Mini-Tinnitus Questionnaire ( Mini-TQ ) , Hospital Anxiety and Depression Scale , Insomnia Severity Index and Tinnitus Acceptance Questionnaire ] were completed at the pre - and post-assessments and at the 6-month follow-up .


Repeated-measures ANOVAs revealed significant time group interaction effects on the primary outcomes ( THI and Mini-TQ scores ) in favor of both CBT interventions compared with the DF at post-assessment ( 0.56 g 0.93 ; all p 0.001 ) .


There were no significant differences between GCBT and ICBT ( all p > 0.05 ) and the treatment effects remained stable at the 6-month follow-up .


This study provides evidence that ICBT might be an equally effective alternative to conventional CBT in the management of chronic tinnitus .


Despite encouraging results , further research is necessary to determine the actual potential of ICBT as a viable alternative to CBT , and under which circumstances it is effective .


To investigate the effect of thorascopic administration.of ginseng polysaccharides ( GPS ) plus dendritic cells ( DC ) on T helper cell type 1/T helper cell type 2 ( Th1/Th2 ) balance in patients with non-small cell lung cancer ( NSCLC ) .


A total of 96 NSCLC patients were divided evenly into two groups .


The control group was treated with DCs alone and the treatment group was treated with DCs plus GPS .


After DCs and GPS were administered thoracoscopically , once a week , 4 times for 30 days , the patients ' quality of life was measured with the Functional Assessment of Cancer Treatment-Lung ( FACT-L ) questionnaire before and after treatment .


Serum interferon - ( INF - ) , interleukin-4 ( IL-4 ) , IL-2 and IL-5 were examined before and after treatments .


The level of Th1 cytokines ( INF - , IL-2 ) and the ratio of Th1/Th2 cytokines ( INF - / IL-4 , IL-2 / IL-5 ) increased in both treatment groups , while Th2 cytokines ( IL-4 , IL-5 ) and FACT-L scores decreased ( P < 0.01 ) .


Furthermore , after treatment Th1 cytokines ( INF - , IL-2 ) and the ratio of Th1/Th2 cytokines ( INF - / IL-4 , IL-2 / IL-5 ) were higher in the DCs + GPS group than in the control group ( P < 0.05 ) .


Conversely , FACT-L scores and Th2 cytokines ( IL-4 , IL-5 ) were higher in the control group than in the DCs + GPS group ( P < 0.05 ) .


The treatment regime of DCs plus GPS had a greater effect on NSCLC patients ' immune function as compared with DCs alone .


This was evident by increased expression of Th1 cytokines ( INF - , IL-2 ) and the ratio of Th1/Th2 ( INF - / IL-4 , IL-2 / IL-5 ) , as well as by decreased FACT-L scores and the expression of Th2 cytokines ( IL-4 , IL-5 ) .


Based on results of the PLATO ( Platelet Inhibition and Patient Outcomes ) trial comparing ticagrelor with clopidogrel therapy , the U.S. Food and Drug Administration approved ticagrelor in 2011 for reducing thrombotic cardiovascular events in patients with acute coronary syndrome ( ACS ) with the proviso that it be taken with low-dose aspirin .


This study sought to assess the cost and cost effectiveness of ticagrelor therapy relative to clopidogrel in treating ACS patients from the perspective of the U.S. health care system .


We estimated within-trial resource use and costs using U.S. low-dose aspirin patients in PLATO ( n = 547 ) .


Quality-adjusted life expectancy was estimated using the total PLATO population ( n = 18,624 ) , combined with baseline risk and long-term survival data from an external ACS patient cohort .


Study drugs were valued at current costs .


Cost effectiveness was assessed , as was the sensitivity of results to sampling and methodological uncertainties .


One year of ticagrelor therapy , relative to that of generic clopidogrel , cost $ 29,665 / quality-adjusted life-year gained , with 99 % of bootstrap estimates falling under a $ 100,000 willingness-to-pay threshold .


Results were robust to extensive sensitivity analyses , including variations in clopidogrel cost , exclusion of costs in extended years of life , and a recalibrated estimate of survival reflecting a lower underlying mortality risk in the United States .


For PLATO-eligible ACS patients , a U.S. perspective comparison of the current standard of dual antiplatelet therapy of aspirin with clopidogrel versus aspirin plus ticagrelor showed that the ticagrelor regimen increased life expectancy at an incremental cost well within accepted benchmarks of good value for money .


( A Comparison of Ticagrelor [ AZD6140 ] and Clopidogrel in Patients With Acute Coronary Syndrome [ PLATO ] ; NCT00391872 ) .


Mipomersen , an apolipoprotein B synthesis inhibitor , demonstrated significant reductions in low-density lipoprotein ( LDL ) cholesterol , non-high density lipoprotein cholesterol , and apolipoprotein B in 4 phase 3 studies at the FDA-approved subcutaneous dose of 200 mg once weekly .


A short-term phase 1 study in healthy volunteers was conducted to evaluate the relative bioavailability , safety , and tolerability of mipomersen in 2 test dose regimens in reference to the 200 mg weekly dose regimen .


Eighty-four adults were randomized to 1 of 3 cohorts ( 30 mg once daily , 70 mg 3 times weekly , or 200 mg once weekly ) and then mipomersen or placebo ( 3:1 ratio ) for 3 weeks of treatment .


Comparable mipomersen post-distribution phase plasma concentrations were observed across the 3 dose regimens suggesting similar tissue exposure .


Injection site reactions were reported , but did not lead to treatment discontinuation .


The median incidence of these responses per injection was decreased by lowering the dose .


Signals from a diverse panel of systemic inflammation markers were essentially indistinguishable between dose regimens and placebo treatment .


The one exception was a modest transient post-dose elevation of C-reactive protein ( CRP ) in the mipomersen 200 mg weekly group .


This elevation was not associated with an increase in other proinflammatory markers .


This study demonstrated a similar drug exposure and overall safety profile between the 3 dosing regimens .


Exploratory assessment of a diverse panel of biomarkers found no indication of a systemic inflammatory response to mipomersen treatment .


These results support assessment of alternative dose regimens in longer-term studies .


http://www.clinicaltrials.gov .


Unique identifier : NCT01061814 .


There is disagreement regarding the performance of conventional optical microscopy to assess the origin of hematuria .


The aim of this study was to determine the optimal cutoff point for dysmorphic cells in order to detect glomerular hematuria by optical and phase-contrast microscopy .


In total , 131 urine samples ( 66 from patients with glomerulopathies and 65 from nephrolithiasis patients ) were evaluated in a blinded fashion .


The percentages of doughnut cells and acanthocytes were verified by optical and phase-contrast microscopy .


A total of 131 patients were randomly allocated to the derivation ( n = 73 ) and validation ( n = 58 ) groups .


Receiver-operating characteristic ( ROC ) curves were plotted to check the discriminatory power of each group and the best cutoff points were determined by the Youden index in the derivation group and subsequently tested in the validation group .


All areas under the ROC curve ( AUCs ) were statistically significant using both methods ( conventional optical and phase-contrast microscopy ) and both groups ( derivation and validation ) .


AUCs did not differ between different glomerulopathies .


The best cutoff point to determine the glomerular origin of hematuria by total dysmorphic cells was 22 % using an optical conventional microscope and 40 % by phase-contrast microscopy .


We determined the best cutoff points to interpret erythrocyte dysmorphism and demonstrated that it is possible to discriminate the origin of hematuria by evaluating erythrocyte dysmorphism in urinalysis using either an optical or a phase-contrast microscope .


Many physicians consider platinum-doublet chemotherapy inappropriate for elderly patients , regardless of their medical fitness .


This was a retrospective subgroup analysis of data from a multicenter , randomized , phase III clinical trial evaluating pemetrexed + carboplatin versus docetaxel + carboplatin in elderly chemo-naive patients with advanced , nonsquamous non-small cell lung cancer ( NSCLC ) .


Data from elderly patients ( aged 65 years and 70 years ) were evaluated using the same statistical methods as those used in patients aged < 70 years and qualified intent-to-treat ( Q-ITT ) populations .


The primary objective of the clinical trial was comparison of pemetrexed + carboplatin with docetaxel + carboplatin in terms of survival without grade 3 or 4 toxicity in chemo-naive NSCLC patients .


The 65 - and 70-year age groups had 68 and 37 patients , respectively .


Among patients aged 65 years , the adjusted hazard ratio ( HR ) for survival without grade 3-4 toxicity ( HR 0.40 , 95 % confidence interval [ CI ] 0.23-0 .70 ) favored pemetrexed + carboplatin ; this was similar to the HRs in patients aged 70 years ( HR 0.43 , 95 % CI 0.20-0 .92 ) , patients aged < 70 years ( HR 0.44 , 95 % CI 0.32-0 .62 ) , and the Q-ITT population ( HR 0.45 , 95 % CI 0.34-0 .61 ) .


The median values for overall survival ( OS ) and progression-free survival ( PFS ) were similar across all age-group subsets and the Q-ITT population .


The HRs for OS and PFS were similar for all age-group subsets , except for the 70-year age group , which favored pemetrexed + carboplatin to a greater extent .


The toxicity profile was similar across age groups , with the exception of diarrhea , mucosal inflammation , and grade 3-4 neutropenia and leukopenia , which were slightly more common in elderly patients in both treatment arms .


Between-arm differences in the toxicity profiles for the 65 - , 70 - and < 70-year age subgroups were similar to those in the Q-ITT population .


There were no on-study deaths or unexpected toxicities .


The benefits of pemetrexed + carboplatin were maintained , and toxicity was manageable in both elderly subgroups .


The favorable risk-benefit profile of pemetrexed + carboplatin makes it an appropriate first-line treatment option for elderly patients with advanced nonsquamous NSCLC .


Fiscal strategies are increasingly considered upstream nutrition promotion measures .


However , few trials have investigated the effectiveness or cost effectiveness of pricing manipulations on diet in real-world settings .


We assessed the effects on fruit , vegetable , and beverage purchasing and consumption of a 20 % price-reduction intervention , a tailored skills-based behavior-change intervention , and a combined intervention compared with a control condition .


The Supermarket Healthy Eating for Life trial was a randomized controlled trial conducted over 3 mo [ baseline ( time 1 ) to postintervention ( time 2 ) with a 6-mo follow-up ( time 3 ) ] .


Female primary household shoppers in Melbourne , Australia , were randomly assigned to a 1 ) skill-building ( n = 160 ) , 2 ) price-reduction ( n = 161 ) , 3 ) combined skill-building and price-reduction ( n = 160 ) , or 4 ) control ( n = 161 ) group .


Supermarket transaction data and surveys were used to measure the following study outcomes : fruit , vegetable , and beverage purchases and self-reported fruit and vegetable consumption at each time point .


At 3 mo ( time 2 ) , price reduction-alone participants purchased more total vegetables and frozen vegetables than did controls .


Price reduction-alone and price reduction-plus-skill-building participants purchased more fruit than did controls .


Relative to controls , in the price-reduction group , total vegetable consumption increased by 233 g/wk ( 3.1 servings or 15 % more than at baseline ) , and fruit purchases increased by 364 g/wk ( 2.4 servings ; 35 % more than at baseline ) .


Increases were not maintained 6 mo postintervention ( time 3 ) .


Price reduction-alone participants showed a tendency for a slight increase in fruit consumption at time 2 ( P = 0.09 ) that was maintained at time 3 ( P = 0.014 ) .


No intervention improved purchases of bottled water or low-calorie beverages .


A 20 % price reduction in fruit and vegetables resulted in increased purchasing per household of 35 % for fruit and 15 % for vegetables over the price-reduction period .


These findings show that price modifications can directly increase produce purchases .


The Supermarket Healthy Eating for Life trial was registered at Current Controlled Trials Registration as ISRCTN39432901 .


C1q/TNF-Related Protein ( CTRP ) family members are novel adipokines that have anti-inflammatory , immunomodulatory , glucose-regulating and vascular effects .


However , the metabolic effects of CTRP9 remain unclear in humans .


The aims of this study were to investigate whether serum CTRP9 concentrations are associated with glucose tolerance , metabolic parameters and abdominal fat accumulation .


In addition , the authors investigated whether the aforementioned effects of CTRP9 are independent of serum adiponectin levels .


A total of 221 subjects ( 140 men and 81 women ) , 25-72 years of age ( mean age 46.0 years ) , were randomly selected from two different study populations .


The normal glucose tolerance group ( n = 120 ) was selected from one study population and the prediabetes/type 2 diabetes group ( n = 101 ) was selected from the other study population .


Serum CTRP9 , total adiponectin concentrations and abdominal fat via computed tomography scan were measured in all subjects .


Subjects in the lower serum CTRP9 tertile were older , had metabolically unhealthy profiles and had lower serum total adiponectin levels when compared with subjects in the middle or upper serum CTRP9 tertiles .


In addition , serum CTRP9 concentration were inversely correlated with age , blood pressure , fasting glucose , homeostasis model assessment for insulin resistance , total cholesterol , triglyceride and low-density lipoprotein cholesterol levels ( all P < 0.01 ) and positively correlated with serum total adiponectin levels ( P = 0.03 ) .


In terms of abdominal fat accumulation , serum CTRP9 concentrations were inversely correlated with visceral fat amount ( P < 0.01 ) , but no correlation was observed with subcutaneous fat amount .


Finally , serum CTRP9 was inversely associated with the presence of metabolic syndrome , independent of age , sex , body mass index , smoking status , total cholesterol , visceral fat and serum total adiponectin concentrations ( odds ratio per 1 s.d. 0.47 ; 95 % confidence interval 0.32-0 .70 ; P < 0.01 ) .


Serum CTRP9 concentrations were positively associated with favorable glucose or metabolic phenotypes and absence of metabolic syndrome , independent of serum total adiponectin concentrations .


Skeletal muscle impairment is a recognized complication of COPD , predicting mortality in severe disease .


Increasing evidence implicates the renin-angiotensin system in control of muscle phenotype .


We hypothesized that angiotensin-converting enzyme ( ACE ) inhibition would improve quadriceps function and exercise performance in COPD .


This double-blind , randomized placebo-controlled trial investigated the effect of the ACE inhibitor , fosinopril , on quadriceps function in patients with COPD with quadriceps weakness .


Primary outcomes were change in quadriceps endurance and atrophy signaling at 3 months .


Quadriceps maximum voluntary contraction ( QMVC ) , mid-thigh CT scan of the cross-sectional area ( MTCSA ) , and incremental shuttle walk distance ( ISWD ) were secondary outcomes .


Eighty patients were enrolled ( mean [ SD ] , 65 [ 8 ] years , FEV1 43 % [ 21 % ] predicted , 53 % men ) .


Sixty-seven patients ( 31 fosinopril , 36 placebo ) completed the trial .


The treatment group demonstrated a significant reduction in systolic BP ( -10.5 mm Hg ; 95 % CI , -19.9 to -1.1 ; P = .03 ) and serum ACE activity ( -20.4 IU/L ; 95 % CI , -31.0 to -9.8 ; P < .001 ) compared with placebo .


No significant between-group differences were observed in the primary end points of quadriceps endurance half-time ( 0.5 s ; 95 % CI , -13.3 -14.3 ; P = .94 ) or atrogin-1 messenger RNA expression ( -0.03 arbitrary units ; 95 % CI , -0.32 -0.26 ; P = .84 ) .


QMVC improved in both groups ( fosinopril : 1.1 kg ; 95 % CI , 0.03-2 .2 ; P = .045 vs placebo : 3.6 kg ; 95 % CI , 2.1-5 .0 ; P < .0001 ) with a greater increase in the placebo arm ( between-group , P = .009 ) .


No change was shown in the MTCSA ( P = .09 ) or ISWD ( P = .51 ) .


This randomized controlled trial found that ACE inhibition , using fosinopril for 3 months , did not improve quadriceps function or exercise performance in patients with COPD with quadriceps weakness .


Current Controlled Trials ; No. : ISRCTN05581879 ; URL : www.controlled-trials.com .


The LUME-Lung 1 trial ( NCT00805194 ; Study 1199.13 ) demonstrated a significant overall survival ( OS ) advantage for nintedanib plus docetaxel compared with placebo plus docetaxel as second-line therapy for patients with advanced non-small cell lung cancer ( NSCLC ) and adenocarcinoma histology .


Patient-reported outcomes ( PROs ) for symptoms and health-related quality of life ( QoL ) are reported here .


PROs were assessed at screening , on Day 1 of each 21-day treatment cycle , at the end of active treatment , and at the first follow-up visit .


PRO instruments were the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and Lung Cancer-13 supplement , and the EuroQol disease-generic questionnaire ( EQ-5D and EQ-VAS ) .


Analyses of PRO items for lung cancer-specific symptoms of cough , dyspnoea and pain were prespecified .


Rates of questionnaire completion were high .


There was no significant difference in time to deterioration of global health status/QoL , or symptoms of cough , dyspnoea or pain , between the treatment groups for both the overall study population and the adenocarcinoma population .


Time to deterioration of some gastrointestinal events was shorter with nintedanib versus placebo .


Longitudinal analysis for the adenocarcinoma population showed comparable changes between the groups in symptom scores over time , with numerical differences in favour of nintedanib for cough and pain scales , and significant reductions in some pain items with nintedanib versus placebo .


There was no statistically significant difference in EQ-5D or EQ-VAS between the groups .


The significant OS benefit observed with the addition of nintedanib to docetaxel therapy was achieved with no detrimental effect on patient self-reported QoL .


Kakkonto , a Japanese herbal medicine , is frequently used to treat the common cold not only with a physician 's prescription , but also in self-medication situations .


This study aimed to examine whether Kakkonto prevents the aggravation of cold symptoms if taken at an early stage of illness compared with a well-selected Western-style multiple cold medicine .


This study was a multicenter , active drug-controlled , randomized trial .


Adults 18 to 65 years of age who felt a touch of cold symptoms and visited 15 outpatient healthcare facilities within 48 hours of symptoms onset were enrolled .


The participants were randomly assigned to two groups : one treated with Kakkonto ( Kakkonto Extract-A , 6 g/day ) ( n = 209 ) and one treated with a Western-style multiple cold medicine ( Pabron Gold-A , 3.6 g/day ) ( n = 198 ) for at most four days .


The primary outcome of this study was the aggravation of cold , nasal , throat or bronchial symptoms , scored as moderate or severe and lasting for at least two days within five days after entry into the study .


Among the 410 enrollees , 340 ( 168 in the Kakkonto group and 172 in the Pabron group ) were included in the analyses .


The proportion of participants whose colds were aggravated was 22.6 % in the Kakkonto group and 25.0 % in the Pabron group ( p = 0.66 ) .


The overall severity of the cold symptoms was not significantly different between the groups .


No harmful adverse events occurred in either group .


Kakkonto did not significantly prevent the progression of cold symptoms , even when prescribed at an early stage of the disease .


Compared with healthy individuals , those with upper respiratory tract illnesses ( URTIs ) report reduced alertness and have slower reaction times .


It is important to evaluate medication that can remove this behavioural malaise .


The aim of this study was to compare the effects of a combination of ibuprofen plus caffeine with ibuprofen and caffeine alone , and placebo on malaise associated with URTIs , as measured by psychomotor performance and mood testing .


Volunteers were randomly assigned to one of four medication conditions as follows : 200mg ibuprofen and 100mg caffeine ; 200mg ibuprofen ; 100mg caffeine ; placebo .


A single oral dose was given and testing followed for 3h .


Efficacy variables were based on the volunteers ' performance , measured by psychomotor performance and mood .


The pre-drug results confirmed that those with an URTI had a more negative mood and impaired performance .


Results from the simple reaction time task , at both 55 - and 110-min post-dosing , showed that a single-dose of caffeinated products ( I200/C100 and CAF100 ) led to significantly faster reaction times than IBU200 and placebo .


These effects were generally confirmed with the other performance tasks .


Subjective measures showed that the combination of ibuprofen and caffeine was superior to the other conditions .


There were no serious adverse events reported , and study medication was well tolerated .


The results from the post-drug assessments suggest that a combination of ibuprofen and caffeine was the optimum treatment for malaise associated with URTIs in that it had significant effects on objective performance and subjective measures .


Recent studies evaluated the disease-modifying properties of lithium in mild cognitive impairment and dementia .


Although potentially effective for these purposes , chronic lithium use in regard to safety in the elderly needs to be better explored .


To evaluate the effect of long-term lithium treatment at subtherapeutic doses on renal function in older adults .


Secondary aims were to evaluate the clinical safety and tolerability of this treatment and its effects on thyroid , immune , and glycemic functions .


Between February 2007 and October 2011 , a 2-year randomized , double-blind , placebo-controlled trial followed by a single-blinded phase for an additional 2 years .


Sixty-one patients with mild cognitive impairment ( Mayo Clinic criteria ) were randomized to receive lithium or placebo .


Renal function was estimated by the abbreviated Modification of Diet in Renal Disease ( aMDRD ) and the Chronic Kidney Disease-Epidemiology study ( CKD-EPI ) equations .


Leukocytes , serum thyroid-stimulating hormone ( TSH ) and free thyroxine ( T ) , and serum glucose and insulin were determined .


Tolerability was evaluated at 3-month intervals through systematic clinical examinations and by the UKU Side Effect Rating Scale .


Analysis of longitudinal regression indicated that no significant changes in renal function were detected by the aMDRD ( P = .453 ) and CKD-EPI ( P = .213 ) equations after 4 years of lithium treatment .


Significant increases in the number of neutrophils ( P = .038 ) , serum TSH ( P = .034 ) , and body weight ( P = .015 ) were observed in the lithium group .


The lithium group presented more overall adverse events ( P = .045 ) , particularly interfering in daily activities ( P < .001 ) .


In addition , those patients had a higher incidence of diabetes mellitus ( P = .037 ) and arrhythmia ( P = .028 ) .


Chronic use of lithium at low doses did not affect renal function and was clinically safe .


However , some other potentially relevant adverse events were observed and others could not be ruled out due to limitations of the study design .


ClinicalTrials.gov identifier : NCT01055392 .


Age-related cognitive decline ( ARCD ) is of major societal concern in an ageing population , with the development of dietary supplements providing a promising avenue for amelioration of associated deficits .


Despite initial interest in the use of phospholipids ( PLs ) for ARCD , in recent years there has been a hiatus in such research .


Because of safety concerns regarding PLs derived from bovine cortex , and the equivocal efficacy of soybean-derived PLs , there is an important need for the development of new PL alternatives .


Phospholipids derived from milk proteins represent one potential candidate treatment .


In order to reduce the effects of age-associated memory impairment ( AAMI ) the Phospholipid Intervention for Cognitive Ageing Reversal ( PLICAR ) was developed to test the efficacy of a milk protein concentrate rich in natural , non-synthetic milk phospholipids ( Lacprodan PL-20 ) .


PLICAR is a randomized , double-blind , placebo-controlled parallel-groups study where 150 ( N = 50/group ) AAMI participants aged > 55 years will be randomized to receive a daily supplement of Lacprodan PL-20 or one of two placebos ( phospholipid-free milk protein concentrate or inert rice starch ) over a 6-month ( 180-day ) period .


Participants will undergo testing at baseline , 90 days and 180 days .


The primary outcome is a composite memory score from the Rey Auditory Verbal Learning Test .


Secondary outcomes include cognitive ( verbal learning , working memory , prospective and retrospective memory , processing speed and attention ) , mood ( depression , anxiety , stress and visual analogue scales ) , cardiovascular ( blood pressure , blood velocity and pulse wave pressure ) , gastrointestinal microbiota and biochemical measures ( oxidative stress , inflammation , B vitamins and Homocysteine , glucoregulation and serum choline ) .


Allelic differences in the Apolipoprotein E and ( APOE ) and Methylenetetrahydrofolate reductase ( MTHFR ) gene will be included for subgroup analysis .


A subset ( N = 60 ; 20/group ) ) will undergo neuroimaging using functional magnetic resonance imaging ( fMRI ) and magnetoencephalography ( MEG ) in order to further explore in vivo central mechanisms of action of Lacprodan PL-20 .


This study will enable evaluation of the efficacy of milk-derived phospholipids for AAMI , and their mechanisms of action .


The trial is jointly funded by Arla Foods and Swinburne University of Technology , currently recruiting and is registered on the Australian New Zealand Clinical Trials Registry as ACTRN12613000347763 .


The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention ( PCI ) has been debated .


Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin ( now called sirolimus ) or its analogues ( everolimus or zotarolimus ) have produced contradictory results , ranging from equivalence between stent types to superiority of everolimus-eluting stents .


We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent .


We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95 % confidence interval of the risk difference .


The primary end point was target-vessel failure , which was defined as a composite of cardiac death , target-vessel myocardial infarction , or ischemia-driven target-vessel revascularization at the 1-year follow-up .


At 1 year , paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point ( rate of target-vessel failure , 5.6 % vs. 2.9 % ; risk difference , 2.7 percentage points [ 95 % confidence interval , 0.8 to 4.5 ] ; relative risk , 1.89 [ 95 % confidence interval , 1.20 to 2.99 ] ; P = 0.38 for noninferiority ) .


There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure ( P = 0.005 ) , spontaneous myocardial infarction ( 3.2 % vs. 1.2 % , P = 0.004 ) , stent thrombosis ( 2.1 % vs. 0.4 % , P = 0.002 ) , target-vessel revascularization ( 3.4 % vs. 1.2 % , P = 0.002 ) , and target-lesion revascularization ( 3.4 % vs. 1.2 % , P = 0.002 ) .


In patients with diabetes mellitus and coronary artery disease undergoing PCI , paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents , and they resulted in higher rates of target-vessel failure , myocardial infarction , stent thrombosis , and target-vessel revascularization at 1 year .


( Funded by Boston Scientific ; TUXEDO-India Clinical Trials Registry-India number , CTRI/2011/06 / 001830 ) .


The purpose of this study was to determine whether sleep changes are a consequence of nicotine presence or withdrawal during the night , we examined 66 healthy non-smokers ( 33 males , 33 females , age : 20-25 years ) after an adaptation night in a sleep laboratory setting .


Subjects were randomized to receive placebo or either 8 or 16 mg nicotine patches during the day or during the night in a double blind , parallel group design .


The 16 mg nicotine patch applied during the night caused a reduced sleep period time and sleep efficiency as well as an increased wake time .


A reduced REM-sleep latency and subjective sleep quality rating were found in subjects receiving nicotine during the night .


Arousals , apneas and periodic leg movements were not affected by nicotine .


This study documents insomnia-like sleep changes in healthy non-smokers caused by nicotine in a dose-dependent manner .


There was no evidence for sleep-related withdrawal symptoms after 13 h of nicotine application .


Dysmenorrhea , the occurrence of painful menstrual cramping of the uterus , is a major cause of activity restriction and absences from school and work among young women .


Standard pharmaceuticals used to treat dysmenorrhea are not effective for all women and have side effects that limit their use .


Studies elsewhere have shown beneficial effects for use of vitamin K1 as an acupoint treatment , but the acceptability of this treatment to women in the United States has been unknown .


The study intended to examine the feasibility , acceptability , and preliminary effects of acupuncture point injection of vitamin K1 as an alternative treatment for primary dysmenorrhea among US women .


The research team conducted a pilot study using a blinded , randomized , crossover trial design .


The study took place at the University of California , San Francisco ( UCSF ) .


The study was conducted in the San Francisco Bay Area among women 18 to 25 y of age who had been diagnosed with primary dysmenorrhea .


Fourteen women completed all of the study 's visits .


Women with primary dysmenorrhea were randomized into 2 groups to receive bilateral injections of vitamin K1 in the Spleen-6 ( SP-6 ) acupuncture point at the start of menstruation and then , following a 2-mo washout period , saline in a nonacupuncture point at the start of menstruation .


One group received the vitamin K1 injection first , while the other group received the saline injection first .


Dysmenorrhea pain intensity was measured using a 0-10 numeric rating scale ( NRS ) , before and after injections .


Women had an average 2.5-point decrease in pain after a vitamin K1 injection in the SP-6 acupoint ( P < .001 ) , as compared with a 1.8-point decrease after a saline injection ( P < .001 ) .


Change scores for vitamin K1 , as compared with a saline injection , approached statistical significance ( P < .10 ) .


Intensity and duration of menstrual symptoms , as measured by the Cox retrospective symptom scale , also decreased following injections .


After participating , 94 % of the women remained agreeable to receiving the injection therapy , and 77 % reported they would come every month were the treatment available .


Findings suggested high acceptability for an acupuncture point injection of vitamin K1 as treatment for primary dysmenorrhea among young women in San Francisco .


Pain decreased with both treatments , with a trend toward greater pain reduction for the vitamin K1/SP -6 injection .


This finding is consistent with outcomes from the Obstetrics and Gynecology Hospital in Shanghai , China , where the protocol was developed .


Current guidelines recommend unfractionated heparin ( UFH ) or low-molecular-weight heparin plus an oral anticoagulant for the prevention of thromboembolism in patients undergoing electric cardioversion of atrial fibrillation ( AF ) .


Selective factor Xa inhibitors , such as fondaparinux , which has a favourable benefit-risk profile in the prevention and treatment of venous thromboembolism and the management of acute coronary syndromes , have not been systematically evaluated in this setting .


To evaluate the efficacy and safety of fondaparinux versus standard treatment in patients undergoing echocardiographically-guided cardioversion of AF .


In this multicentre , randomized , open-label , controlled , two-parallel-group , phase II pilot study , patients with AF undergoing electric cardioversion following transoesophageal echocardiography ( TEE ) were randomized to fondaparinux or standard therapy ( UFH plus vitamin K antagonist [ VKA ] ) .


Patients showing an atrial thrombus in the first TEE ( clot-positive ) were randomized to treatment with fondaparinux or standard care for 4 weeks before cardioversion .


The primary endpoint ( combined rate of cerebral neurological events , systemic thromboembolism , all-cause death and major bleeding events ) occurred in 3 of 174 ( 1.7 % ) patients on fondaparinux and 2 of 170 ( 1.2 % ) patients on UFH+VKA .


The rate of thrombus disappearance among clot-positive patients was higher in the fondaparinux arm ( 11 of 14 ; 78.6 % ) than in the UFH+VKA arm ( 7 of 14 ; 50.0 % ) .


Incidences of adverse events were similar ( 45.4 % with fondaparinux and 46.5 % with UFH+VKA ) .


In this pilot study in patients with TEE-guided cardioversion , the use of fondaparinux appeared to be well tolerated , with similar efficacy to UFH+VKA .


Furthermore , a trend to greater thrombus resolution was observed .


It remains unclear whether concomitant radiofrequency ablation procedure in valvular surgery could offer additional benefits to patients with rheumatic valvular disease .


We designed a prospective and randomized control study to evaluate the efficacy of surgical radiofrequency ablation in patients with rheumatic heart disease .


From June 2008 to July 2011 , 210 patients with chronic atrial fibrillation and rheumatic heart disease were randomized : ( 1 ) control group , patients underwent only valve replacement followed by amiodarone for rhythm control , ( 2 ) left atrial group ( LA group ) , patients underwent valve replacement and left atrial mono-polar radiofrequency ablation , ( 3 ) bi-atrial group ( BA group ) , patients underwent valve replacement and bi-atrial mono-polar radiofrequency ablation .


The primary endpoints included : cardiac death , stroke , and recurrent AF after discharge .


There was no perioperative death .


One patient died 4 months after MVR in BA group .


In univariate Cox analysis , the two ablation groups were associated with less AF ( BA group vs control group : P < 0.001 ; LA group vs control group : P < 0.001 ) as well as atrial tachycardia arrhythmia ( AF/AT/AFL ) recurrent ( BA group vs control group : P < 0.001 ; LA group vs control group : P = 0.02 ) .


The comparison between BA and LA groups revealed no differences in terms of AF ( P = 0.06 ) or AF/AT/AFL ( P = 0.09 ) .


Atrial transport function restoration rate 12 months after operation was 31.4 % in LA group , 32.9 % in BA group , and 8.6 % in control group respectively ( P < 0.01 ) .


Radiofrequency ablation concurring with valvular surgery can bring a higher sinus rhythm restoration rate when compared with medical anti-arrhythmic drug therapy in low-medium risk rheumatic heart disease .


The trial was registered on Clinicaltrials.gov ( registry number NCT01013688 ) .


This study examined the role of independence centrality ( the personal importance of being functionally independent ) in adapting to functional disability in persons with spinal cord injury ( SCI ) .


We assessed how changes in disability related to changes in depressive symptoms , the association between independence centrality and depressive symptoms , and the role of independence centrality in moderating the association between changes in disability and changes in depressive symptoms .


Using data from a randomized controlled trial , we focused on 173 survivors of SCI who completed baseline and 12-month follow-up measures of independence centrality , disability ( activities of daily living and instrumental activities of daily living needs ) , and depressive symptoms .


Consistent with our predictions , increased disability was related to increased depressive symptoms , and higher independence centrality was associated with more depressive symptoms at baseline .


Consistent with the life span theory of control , SCI survivors with high independence centrality experienced more depressive symptoms when disability increased , but less depressive symptoms when disability decreased .


Survivors of SCI with low independence centrality were less affected by changing levels of disability .


Persons with SCI with high independence centrality have higher levels of depressive symptoms and are more responsive to changes in functional status .


Given the functional status trajectories of survivors of SCI , having low independence centrality may be adaptive because it facilitates disengagement from unattainable goals .


Creatinine ( Cr ) has been implicated as an independent predictor of hypertension and exercise has been reported as adjunct therapy for hypertension .


The purpose of the present study was to investigate the effect of continuous training programme on blood pressure and serum creatinine concentration in black African subjects with hypertension .


Three hundred and fifty seven male patients with mild to moderate ( systolic blood pressure [ SBP ] between 140-180 & diastolic blood pressure [ DBP ] between 90-109 mmHg ) essential hypertension were age matched and randomly grouped into continuous & control groups .


The continuous group involved in an 8 weeks continuous training ( 60-79 % HR reserve ) of between 45 minutes to 60 minutes , 3 times per week , while the control group remain sedentary .


SBP , DBP , VO2max , serum Cr , body mass index ( BMI ) , waist hip ratio ( WHR ) and percent ( % ) body fat .


Analysis of covariance ( ANCOVA ) and Pearson correlation tests were used in data analysis .


Findings of the study revealed significant decreased effects of continuous training programme on SBP , DBP , Cr , BMI , WHR , % body fat and significant increase in VO2max at p < 0.05 .


Serum Cr is significantly and negatively correlated with SBP ( -.335 ) , DBP ( .194 ) , BMI ( .268 ) , WHR ( -.258 ) and % body fat ( -.190 ) at p < 0.05 .


The present study demonstrated a rationale bases for the adjunct therapeutic role of moderate intensity continuous exercise training as a multi-therapy in the down regulation of blood pressure , serum Cr , body size and body fat in hypertension .


Exercise is consistently recommended for older adults with knee pain related to osteoarthritis .


However , the effects from exercise are typically small and short-term , likely linked to insufficient individualisation of the exercise programme and limited attention to supporting exercise adherence over time .


The BEEP randomised trial aims to improve patients ' short and long-term outcomes from exercise .


It will test the overall effectiveness and cost-effectiveness of two physiotherapy-led exercise interventions ( Individually Tailored Exercise and Targeted Exercise Adherence ) to improve the individual tailoring of , and adherence to exercise , compared with usual physiotherapy care .


Based on the learning from a pilot study ( ISRCTN 23294263 ) , the BEEP trial is a multi-centre , pragmatic , parallel group , individually randomised controlled trial , with embedded longitudinal qualitative interviews .


500 adults in primary care , aged 45 years and over with knee pain will be randomised to 1 of 3 treatment groups delivered by fully trained physiotherapists in up to 6 NHS services .


These are : Usual Physiotherapy Care ( control group consisting of up to 4 treatment sessions of advice and exercise ) , Individually Tailored Exercise ( an individualised , supervised and progressed lower-limb exercise programme ) or Targeted Exercise Adherence ( supporting patients to adhere to exercise and to engage in general physical activity over the longer-term ) .


The primary outcomes are pain and function as measured by the Western Ontario and McMaster Osteoarthritis index .


A comprehensive range of secondary outcomes are also included .


Outcomes are measured at 3 , 6 ( primary outcome time-point ) , 9 , 18 and 36 months .


Data on adverse events will also be collected .


Semi-structured , qualitative interviews with a subsample of 30 participants ( 10 from each treatment group ) will be undertaken at two time-points ( end of treatment and 12 to 18 months later ) and analysed thematically .


This trial will contribute to the evidence base for management of older adults with knee pain attributable to osteoarthritis in primary care .


The findings will have important implications for healthcare commissioners , general practitioners and physiotherapy service providers and it will inform future education of healthcare practitioners .


It may also serve to delay or prevent some individuals from becoming surgical candidates .


ISRCTN93634563 .


To investigate whether Myofascial release ( MFR ) when used as an adjunct to specific back exercises ( SBE ) reduces pain and disability in chronic low back pain ( CLBP ) in comparison with a control group receiving a sham Myofascial release ( SMFR ) and specific back exercises ( SBE ) among nursing professionals .


Randomized , controlled , single blinded trial .


Nonprofit research foundation clinic in Kerala , India .


Nursing professionals ( N = 80 ) with chronic low back pain ( CLBP ) .


MFR group or control group .


The techniques were administered by physiotherapists certified in MFR and consisted of 24 sessions per client over 8 weeks .


The McGill Pain Questionnaire ( MPQ ) was used to assess subjective pain experience and Quebec Back Pain Disability Scale ( QBPDS ) was used to assess the disability associated with CLBP .


The primary outcome measure was the difference in MPQ and QBPDS scores between week 1 ( pretest score ) , week 8 ( posttest score ) , and follow-up at week 12 after randomization .


The simple main effects analysis showed that the MFR group performed better than the control group in weeks 8 and 12 ( P < 0.005 ) .


The patients in the MFR group reported a 53.3 % reduction in their pain and 29.7 % reduction in functional disability as shown in the MPQ and QBPDS scores in week 8 , whereas patients in the control group reported a 26.1 % and 9.8 % reduction in their MPQ and QBPDS scores in week 8 , which persisted as a 43.6 % reduction of pain and 22.7 % reduction of functional disability in the follow-up at week 12 in the MFR group compared to the baseline .


The proportion of responders , defined as participants who had at least a 50 % reduction in pain between weeks 1 and 8 , was 73 % in the MFR group and 0 % in the control group , which was 0 % for functional disability in the MFR and control group .


This study provides evidence that MFR when used as an adjunct to SBE is more effective than a control intervention for CLBP in nursing professionals .


Persons with a mental disorder smoke at higher rates and suffer disproportionate tobacco-related burden compared with the general population .


The aim of this study was to determine if a smoking cessation intervention initiated during a psychiatric hospitalization and continued postdischarge was effective in reducing smoking behaviors among persons with a mental disorder .


A randomized controlled trial was conducted at an Australian inpatient psychiatric facility .


Participants were 205 patient smokers allocated to a treatment as usual control ( n = 101 ) or a smoking cessation intervention ( n = 104 ) incorporating psychosocial and pharmacological support for 4 months postdischarge .


Follow-up assessments were conducted at 1 week , 2 , 4 , and 6 months postdischarge and included abstinence from cigarettes , quit attempts , daily cigarette consumption , and nicotine dependence .


Rates of continuous and 7-day point prevalence abstinence did not differ between treatment conditions at the 6-month follow-up ; however , point prevalence abstinence was significantly higher for intervention ( 11.5 % ) compared with control ( 2 % ) participants at 4 months ( OR = 6.46 , p = .01 ) .


Participants in the intervention condition reported significantly more quit attempts ( F [ 1 , 202.5 ] = 15.23 , p = .0001 ) , lower daily cigarette consumption ( F [ 4 , 586 ] = 6.5 , p < .001 ) , and lower levels of nicotine dependence ( F [ 3 , 406 ] = 8.5 , p < .0001 ) compared with controls at all follow-up assessments .


Postdischarge cessation support was effective in encouraging quit attempts and reducing cigarette consumption up to 6 months postdischarge .


Additional support strategies are required to facilitate longer-term cessation benefits for smokers with a mental disorder .


The aim of this study was test the hypothesis that homeopathy ( H ) enhances the effects of scaling and root planing ( SRP ) in patients with chronic periodontitis ( CP ) .


50 patients with CP were randomly allocated to one of two treatment groups : SRP ( C-G ) or SRP + H ( H-G ) .


Assessments were made at baseline and after 3 and 12 months of treatments .


The local and systemic responses to the treatments were evaluated by clinical and serologic parameters , respectively .


Both groups displayed significant improvements , however , using clinical attachment gain and reductions in HDL , LDL and Total Cholesterol , Triglycerides , Glucose and Uric acid , from baseline to 1 year , as criteria for treatment success , H-G performed significantly better than C-G .


The findings of this 1-year follow-up randomized clinical trial suggest that homeopathic medicines , as an adjunctive to SRP , can provide significant local and systemic improvements for CP patients .


Sublingual misoprostol , used for labor induction , produces earlier and higher peak plasma concentrations of misoprostol than vaginal or rectal misoprostol .


The sublingual route could be expected to be more effective and safer than the vaginal route and by avoiding a direct effect on the cervix , it might reduce the risk of uterine hyperstimulation and be safer .


This study aimed to compare the efficacy of 25-g sublingual misoprostol with 50-g intravaginal misoprostol for cervical ripening prior to labor induction in primiparous women .


In a double-blind , parallel randomized controlled equivalence trial , we recruited 131 primiparous women at 36-42 weeks of gestation requiring labor induction who referred to Alzahara hospital in Rasht , Iran .


The women were randomly assigned to receive 25-g sublingual misoprostol with vaginal placebo ( n = 63 ) or 50-g intravaginal misoprostol with sublingual placebo ( n = 63 ) .


The dose was repeated every 4 h ( maximum 4 doses ) .


The primary outcome was the interval from the start of induction to vaginal delivery .


There were no significant differences between the two groups with regard to the interval from the start of induction to vaginal delivery ( 13.2 3.07 h in the vaginal group vs. 13.1 3.46 h in the sublingual group ) , duration of active phase , Bishop Scores after 4h , and rate of the vaginal delivery under 12 h. Also , the rate of hyperstimulation , tachysystole , type of delivery , cause of cesarean section , Apgar scores less than 7 and admission to the NICU were similar in these two groups .


The mean dose of misoprostol applied was significantly lower in the sublingual group ( P = 0.001 ) .


Sublingual administration of 25-g of misoprostol appears to be as effective as 50 g intravaginal misoprostol for cervical ripening and labor induction .


This trial has been registered under IRCT 38903131096N3 .


Optimal ventilator management for patients with acute respiratory distress syndrome ( ARDS ) remains uncertain .


Lower tidal volume ventilation appears to be beneficial , but optimal management of positive end-expiratory pressure ( PEEP ) remains unclear .


The Esophageal Pressure-Guided Ventilation 2 Trial ( EPVent2 ) aims to examine the impact of mechanical ventilation directed at maintaining a positive transpulmonary pressure ( PTP ) in patients with moderate-to-severe ARDS .


EPVent2 is a multicentre , prospective , randomised , phase II clinical trial testing the hypothesis that the use of a PTP-guided ventilation strategy will lead to improvement in composite outcomes of mortality and time off the ventilator at 28days as compared with a high-PEEP control .


This study will enrol 200 study participants from 11 hospitals across North America .


The trial will utilise a primary composite end point that incorporates death and days off the ventilator at 28days to test the primary hypothesis that adjusting ventilator pressure to achieve positive PTP values will result in improved mortality and ventilator-free days .


Safety oversight will be under the direction of an independent Data and Safety Monitoring Board ( DSMB ) .


Approval of the protocol was obtained from the DSMB prior to enrolling the first study participant .


Approvals of the protocol as well as informed consent documents were also obtained from the Institutional Review Board of each participating institution prior to enrolling study participants at each respective site .


The findings of this investigation , as well as associated ancillary studies , will be disseminated in the form of oral and abstract presentations at major national and international medical specialty meetings .


The primary objective and other significant findings will also be presented in manuscript form .


All final , published manuscripts resulting from this protocol will be submitted to PubMed Central in accordance with the National Institute of Health Public Access Policy .


ClinicalTrials.gov under number NCT01681225 .


This study examines the impact of major depressive disorder ( MDD ) and its treatment on quality of life ( QOL ) .


From the Sequenced Treatment Alternatives to Relieve Depression ( STAR * D ) trial , we analyzed complete data of 2280 adult MDD out-patients at entry/exit of each level of antidepressant treatments and after 12 months of entry to follow-up .


QOL was measured using the QOL Enjoyment and Satisfaction Questionnaire ( Q-LES-Q ) .


The proportions of patients scoring ` within-normal ' QOL ( within 10 % of Q-LES-Q community norms ) and those with ` severely impaired ' QOL ( > 2SD below Q-LES-Q community norms ) were analyzed .


Before treatment , no more than 3 % of MDD patients experienced ` within-normal ' QOL .


Following treatment , statistically significant improvements were detected ; however , the proportion of patients achieving ` within-normal ' QOL did not exceed 30 % , with > 50 % of patients experiencing ` severely impaired ' QOL .


Although remitted patients had greater improvements compared with non-remitters , 32-60 % continued to experience reduced QOL .


12-month follow-up data revealed that the proportion of patients experiencing ` within-normal ' QOL show a statistically significant decrease in non-remitters .


Symptom-focused treatments of MDD may leave a misleading impression that patients have recovered when , in fact , they may be experiencing ongoing QOL deficits .


These findings point to the need for investigating specific interventions to ameliorate QOL in MDD .


This intervention sought to promote healthy eating with the ultimate goal of reducing childhood obesity risk .


Three hundred and sixty-one Latino families living on the US-Mexico border with at least one child between 7-13 years of age were eligible to participate .


Families randomly assigned to the four-month intervention received 14 contacts with a promotora ( community health worker ) , consisting of 11 home visits and three telephone calls ; the control condition was a delayed treatment intervention .


Children reported on their dietary intake at baseline , immediately post-intervention and at the six month follow-up visit .


The intervention reduced weekly consumption of fast food ( p < 0.05 ) .


A dose-response relationship was observed such that for every seven hours of promotora contact , monthly variety of fruits ( p < 0.01 ) and vegetables ( p < 0.01 ) increased by one .


No other intervention effects were observed .


Family-based interventions can improve children 's eating habits , with the amount of contact with the promotora being key to success .


Spastic pes equinovarus is a frequent pathological posture of the lower extremity .


Botulinum toxin ( BoNT/A ) has been successfully applied to treat lower limb spasticity .


However , the best time to initiate treatment remains unclear .


A beneficial effect of an early treatment has been suggested in previous studies .


A single-centre double-blind randomized placebo-controlled trial was performed to investigate the efficacy of BoNT/A to reduce muscle hypertonicity at the ankle .


Fifty-two patients with unilateral or bilateral spastic pes equinovarus with a modified Ashworth score ( mAS ) of at least 1 + after stroke , traumatic brain injury or hypoxic encephalopathy were allocated to receive either BoNT/A or placebo treatment .


A second , open injection was optional at week 12 .


Patients received unilateral or bilateral injections with 230 or 460U onabotulinumtoxinA , respectively .


The course of the mAS was explored during the open study phase .


Patients who had received BoNT/A treatment had lower mAS compared with placebo at week 12 ( P < 0.01 ) .


During the open label phase , patients from the placebo group showed further deterioration of muscle tone despite starting from a similar baseline and receiving BoNT treatment .


Spastic feet that had received BoNT/A in the first cycle had comparatively lower mAS scores over all follow-up data and at week 24 ( P < 0.01 ) .


The study demonstrates a reduction of muscular hypertonicity in spastic pes equines with BoNT/A treatment given during the first 3months after the lesion .


Exploratory analyses of the course of muscular hypertonicity during the open phase favour earlier to later treatment .