We evaluated an intervention to interrupt tuberculosis transmission by means of mass screening that was linked to treatment for active disease or latent infection .


In a cluster-randomized study , we designated 15 clusters with 78,744 miners as either intervention clusters ( 40,981 miners in 8 clusters ) or control clusters ( 37,763 miners in 7 clusters ) .


In the intervention clusters , all miners were offered tuberculosis screening .


If active tuberculosis was diagnosed , they were referred for treatment ; if not , they were offered 9 months of isoniazid preventive therapy .


The primary outcome was the cluster-level incidence of tuberculosis during the 12 months after the intervention ended .


Secondary outcomes included tuberculosis prevalence at study completion .


In the intervention clusters , 27,126 miners ( 66.2 % ) underwent screening .


Of these miners , 23,659 ( 87.2 % ) started taking isoniazid , and isoniazid was dispensed for 6 months or more to 35 to 79 % of miners , depending on the cluster .


The intervention did not reduce the incidence of tuberculosis , with rates of 3.02 per 100 person-years in the intervention clusters and 2.95 per 100 person-years in the control clusters ( rate ratio in the intervention clusters , 1.00 ; 95 % confidence interval [ CI ] , 0.75 to 1.34 ; P = 0.98 ; adjusted rate ratio , 0.96 ; 95 % CI , 0.76 to 1.21 ; P = 0.71 ) , or the prevalence of tuberculosis ( 2.35 % vs. 2.14 % ; adjusted prevalence ratio , 0.98 ; 95 % CI , 0.65 to 1.48 ; P = 0.90 ) .


Analysis of the direct effect of isoniazid in 10,909 miners showed a reduced incidence of tuberculosis during treatment ( 1.10 cases per 100 person-years among miners receiving isoniazid vs. 2.91 cases per 100 person-years among controls ; adjusted rate ratio , 0.42 ; 95 % CI , 0.20 to 0.88 ; P = 0.03 ) , but there was a subsequent rapid loss of protection .


Mass screening and treatment for latent tuberculosis had no significant effect on tuberculosis control in South African gold mines , despite the successful use of isoniazid in preventing tuberculosis during treatment .


( Funded by the Consortium to Respond Effectively to the AIDS TB Epidemic and others ; Thibela TB Current Controlled Trials number , ISRCTN63327174 . )


Our main objective was to evaluate the ability of cranberry phytochemicals to modify immunity , specifically - T cell proliferation , after daily consumption of a cranberry beverage , and its effect on health outcomes related to cold and influenza symptoms .


The study was a randomized , double-blind , placebo-controlled , parallel intervention .


Subjects drank a low calorie cranberry beverage ( 450 ml ) made with a juice-derived , powdered cranberry fraction ( n = 22 ) or a placebo beverage ( n = 23 ) , daily , for 10 wk .


PBMC were cultured for six days with autologous serum and PHA-L stimulation .


Cold and influenza symptoms were self-reported .


The proliferation index of - T cells in culture was almost five times higher after 10 wk of cranberry beverage consumption ( p < 0.001 ) .


In the cranberry beverage group , the incidence of illness was not reduced , however significantly fewer symptoms of illness were reported ( p = 0.031 ) .


Consumption of the cranberry beverage modified the ex vivo proliferation of - T cells .


As these cells are located in the epithelium and serve as a first line of defense , improving their function may be related to reducing the number of symptoms associated with a cold and flu .


Neonates at risk for early-onset sepsis are started on antibiotics empirically .


Antibiotic resistance to conventionally used antibiotics is increasingly being reported .


Antenatal maternal antibiotic exposure in this setting contributes to low yield on blood culture drawn at birth , limiting the planning of antibiotics based on culture reports .


A head-to-head comparison for selecting the appropriate antibiotic is one strategy .


To compare monotherapy with amikacin against piperacillin-tazobactum as an empirical therapy in neonates at risk for early-onset sepsis .


Randomized open-label controlled trial with stratification and block randomization .


Tertiary care neonatal unit in India


All consecutive inborn neonates delivered between 01 May 2009 and 30 April 2011 who were 28 week gestation and/or 1000 g birth weight with risk factors for early-onset sepsis .


Randomized to receive either amikacin or piperacillin-tazobactum , after stratifying as asymptomatic or symptomatic within 1 h of birth .


Incidence of treatment failure to the allocated antibiotic defined as blood culture isolate reported resistant to the allocated antibiotic or progression of the illness , necessitating a change of antibiotic .


Of 204 eligible cases , 187 were enrolled .


Seventeen babies were excluded .


A total of 128 neonates were stratified as asymptomatic and 59 as symptomatic .


In all , 64 of the asymptomatic cases received amikacin and 64 received piperacillin-tazobactum , while 29 symptomatic babies received amikacin and 30 received piperacillin-tazobactum .


Five babies had blood culture-positive sepsis , and 28 babies had strong suspicion of sepsis .


There was no difference in the treatment failure in the amikacin group ( 3 of 93 ; 3.2 % ) compared with piperacillin-tazobactum group ( 2 of 94 ; 2.1 % ) ( p > 0.01 ) and no difference in the incidence of second infection , fungal sepsis and all-cause mortality at day 7 and 28 between the two study groups ( p > 0.01 ) .


Monotherapy with amikacin as an empirical antibiotic did not result in a higher incidence of treatment failure in neonates at risk for early-onset sepsis as compared with piperacillin-tazobactum .


Both antibiotics were effective in management of babies with early-onset sepsis .


The level of anticoagulation in response to a fixed-dose regimen of warfarin is difficult to predict during the initiation of therapy .


We prospectively compared the effect of genotype-guided dosing with that of standard dosing on anticoagulation control in patients starting warfarin therapy .


We conducted a multicenter , randomized , controlled trial involving patients with atrial fibrillation or venous thromboembolism .


Genotyping for CYP2C9 * 2 , CYP2C9 * 3 , and VKORC1 ( -1639 GA ) was performed with the use of a point-of-care test .


For patients assigned to the genotype-guided group , warfarin doses were prescribed according to pharmacogenetic-based algorithms for the first 5 days .


Patients in the control ( standard dosing ) group received a 3-day loading-dose regimen .


After the initiation period , the treatment of all patients was managed according to routine clinical practice .


The primary outcome measure was the percentage of time in the therapeutic range of 2.0 to 3.0 for the international normalized ratio ( INR ) during the first 12 weeks after warfarin initiation .


A total of 455 patients were recruited , with 227 randomly assigned to the genotype-guided group and 228 assigned to the control group .


The mean percentage of time in the therapeutic range was 67.4 % in the genotype-guided group as compared with 60.3 % in the control group ( adjusted difference , 7.0 percentage points ; 95 % confidence interval , 3.3 to 10.6 ; P < 0.001 ) .


There were significantly fewer incidences of excessive anticoagulation ( INR 4.0 ) in the genotype-guided group .


The median time to reach a therapeutic INR was 21 days in the genotype-guided group as compared with 29 days in the control group ( P < 0.001 ) .


Pharmacogenetic-based dosing was associated with a higher percentage of time in the therapeutic INR range than was standard dosing during the initiation of warfarin therapy .


( Funded by the European Commission Seventh Framework Programme and others ; ClinicalTrials.gov number , NCT01119300 . )


Subjective response to alcohol represents a marker of alcoholism risk .


The A118G single-nucleotide polymorphism ( SNP ) of the mu opioid receptor ( OPRM1 ) gene has been associated with subjective response to alcohol .


Recently , the dopamine transporter ( DAT1 ) variable number of tandem repeat ( VNTR ; SLC6A3 ) has been found to interact with the OPRM1 A118G SNP in predicting neural and behavioral responses to naltrexone and to alcohol .


This exploratory study examines the OPRM1 DAT1 interaction on subjective responses to alcohol .


Non-treatment-seeking problem drinkers ( n = 295 ) were assessed in the laboratory for alcohol dependence .


Following prospective genotyping for the OPRM1 gene , 43 alcohol-dependent individuals were randomized to two intravenous infusion sessions , one of alcohol ( target BrAC = 0.06 g/dl ) and one of saline .


Measures of subjective responses to alcohol were administered in both infusion sessions .


Analyses revealed significant Alcohol OPRM1 DAT1 interactions for alcohol-induced stimulation , vigor and positive mood as well as significant Alcohol OPRM1 DAT1 Time interactions for stimulation and positive mood .


These effects were such that , compared with other genotype groups , OPRM1 G-allele carriers + DAT1 A10 homozygotes reported steeper increases in stimulation and positive mood across rising BrAC , when compared with placebo .


All Alcohol OPRM1 DAT1 interactions remained significant when analyses were restricted to a subsample of Caucasian participants ( n = 34 ) ; however , 4-way interactions did not reach statistical significance in this subsample .


This study suggests that the contribution of OPRM1 genotype to alcohol-induced stimulation , vigor and positive mood is moderated by DAT1 genotype .


These findings are consistent with the purported interaction between opioidergic and dopaminergic systems in determining the reinforcing properties of alcohol .


Women with late preterm premature rupture of membranes ( PROM ) have an increased risk that their child will develop neonatal sepsis .


We evaluated whether neonatal sepsis can be predicted from antepartum parameters in these women .


We used multivariable logistic regression to develop a prediction model .


Data were obtained from two recent randomized controlled trials on induction of labor versus expectant management in late preterm PROM ( PPROMEXIL trials , ( ISRCTN29313500 and ISRCTN05689407 ) .


Data from randomized as well as non-randomized women , who consented to the use of their medical data , were used .


We evaluated 13 potential antepartum predictors for neonatal sepsis .


Missing data were imputed .


Discriminative ability of the model was expressed as the area under the receiver operating characteristic ( ROC ) curve and a calibration with both a calibration plot and the Hosmer and Lemeshow goodness-of-fit test .


Overall performance of the prediction model was quantified as the scaled Brier score .


We studied 970 women .


Thirty-three ( 3.4 % ) neonates suffered neonatal sepsis .


Maternal age ( OR 1.09 per year ) , maternal CRP level ( OR 1.01 per mmol/l ) , maternal temperature ( OR 1.80 per C ) and positive GBS culture ( OR 2.20 ) were associated with an increased risk of neonatal sepsis .


The model had an area under the ROC-curve of 0.71 .


The model had both a good calibration and accuracy .


Antepartum parameters aid in the more precise prediction of the risk of neonatal sepsis in women with late preterm PPROM .


The Canadian Fabry disease initiative ( CFDI ) tracks outcomes of subjects with Fabry disease treated enzyme replacement therapy ( ERT ) given to subjects who meet evidence-based treatment guidelines and cardiovascular risk factor modification .


We report 5 year follow-up data on 362 subjects for a composite endpoint ( death , neurologic or cardiovascular events , development of end-stage renal disease or sustained increase in serum creatinine of 50 % from baseline ) .


At enrollment , 86 subjects had previously received ERT ( Cohort 1a ) and 67 subjects were newly started ( Cohort 1b ) and randomized to agalsidase alfa or agalsidase beta .


209 subjects did not initially meet ERT criteria ( Cohort 1c ) , 25 of whom met ERT criteria in follow-up and were moved to Cohort 1b ( total N = 178 ERT treated subjects ) .


Use of supportive therapies such as aspirin ( 78 % ) , renin-angiotensin blockade ( 59 % ) , and statins ( 55 % ) was common in ERT treated subjects .


In Cohort 1a , 32 subjects met the composite endpoint with 8 deaths .


In Cohort 1b , 16 subjects met the composite endpoint with 1 death .


Cohort 1b had fewer clinical events than Cohort 1a ( p = 0.039 ) suggesting that the treatment protocol was effective in targeting subjects at an earlier stage .


19.4 % of Cohort 1b subjects on agalsidase alfa and 13.3 % on agalsidase beta had a clinical event ( p = 0.57 ) .


10 Cohort 1c subjects had clinical events , none of which would have been prevented by earlier use of ERT .


Cardiovascular risk factor modification and targeted use of ERT reduce the risk of adverse outcomes related to Fabry disease .


Prostate capsule sparing and nerve sparing cystectomies are alternative procedures for bladder cancer that may decrease morbidity while achieving cancer control .


However , to our knowledge the comparative effectiveness of these approaches has not been established .


We evaluated functional and oncologic outcomes in patients undergoing these procedures .


We performed a single institution trial in patients with bladder cancer in whom transurethral prostatic urethral biopsy and transrectal prostate biopsy were negative .


Men were randomized to prostate capsule sparing or nerve sparing cystectomy with neobladder creation and stratified by Sexual Health Inventory for Men score ( greater than 21 vs 21 or less ) .


Our primary end point was 12-month overall urinary function as measured by Bladder Cancer Index .


Secondary end points included sexual function , cancer control and complications .


A total of 40 patients were enrolled in the study with 20 patients in each arm .


Urinary function at 12 months decreased by 13 and 28 points in the prostate capsule and nerve sparing groups , respectively ( p = 0.10 ) .


Sexual function followed a similar pattern ( p = 0.06 ) .


There was no difference in recurrence-free , metastasis-free or overall survival ( each p > 0.05 ) .


The rate of incidentally detected prostate cancer was similar ( p = 0.15 ) .


Our study provides a randomized comparison of prostate capsule sparing and nerve sparing cystectomy techniques .


We found no difference in functional or oncologic outcomes between the 2 approaches , although our study was underpowered due to a lack of patient accrual .


Following the demonstrated efficacy and safety of eribulin mesylate in heavily pretreated patients with metastatic breast cancer , an exploratory analysis was performed to investigate the effect of age in these patients .


Data were pooled from two single-arm phase II studies and one open-label randomized phase III study in which patients received eribulin mesylate at 1.4 mg/m ( 2 ) as 2 - to 5-minute intravenous infusions on days 1 and 8 of a 21-day cycle .


The effect of age on median overall survival ( OS ) , progression-free survival ( PFS ) , overall response rate ( ORR ) , clinical benefit rate ( CBR ) , and incidence of adverse events ( AEs ) was calculated for four age groups ( < 50 years , 50-59 years , 60-69 years , 70 years ) .


RESULTS .


Overall , 827 patients were included in the analysis ( < 50 years , n = 253 ; 50-59 years , n = 289 ; 60-69 years , n = 206 ; 70 years , n = 79 ) .


Age had no significant impact on OS ( 11.8 months , 12.3 months , 11.7 months , and 12.5 months , respectively ; p = .82 ) , PFS ( 3.5 months , 2.9 months , 3.8 months , and 4.0 months , respectively ; p = .42 ) , ORR ( 12.7 % , 12.5 % , 6.3 % , and 10.1 % , respectively ) , or CBR ( 20.2 % , 20.8 % , 20.4 % , and 21.5 % , respectively ) .


Although some AEs had higher incidence in either the youngest or the oldest subgroup , there was no overall effect of age on the incidence of AEs ( including neuropathy , neutropenia , and leukopenia ) .


Eribulin monotherapy in these selected older patients with good baseline performance status led to OS , PFS , ORR , CBR , and tolerability similar to those of younger patients with metastatic breast cancer .


The benefits and risks of eribulin appear to be similar across age groups .


To evaluate the efficacy , tolerability , and safety of once-daily 1200 mg and 2400 mg SPN-804 ( Oxtellar XR , Supernus Pharmaceuticals ) , an extended-release tablet formulation of oxcarbazepine ( OXC ) , added to 1-3 concomitant antiepileptic drugs ( AEDs ) in adults with refractory partial-onset seizures , with or without secondary generalization .


The Prospective , Randomized Study of OXC XR in Subjects with Partial Epilepsy Refractory ( PROSPER ) study was a multinational , randomized , double-blind , parallel-group Phase 3 study .


The primary efficacy endpoint was median percent reduction from baseline in monthly ( 28-day ) seizure frequency for the 16-week double-blind treatment period in the intent-to-treat ( ITT ) population with analyzable seizure data .


Other efficacy analyses included proportion of patients with 50 % seizure reduction , proportion of patients seizure free , and the relationship between clinical response and plasma concentration .


Median percent reduction was -28.7 % for placebo , -38.2 % ( P = 0.08 vs placebo ) for once-daily SPN-804 1200 mg , and -42.9 % ( P = 0.003 ) for SPN-804 2400 mg .


Responder rates were 28.1 % , 36.1 % ( P = 0.08 ) , and 40.7 % ( P = 0.02 ) ; 16-week seizure-free rates in a pragmatic ITT analysis were 3.3 % , 4.9 % ( P = 0.59 ) , and 11.4 % ( P = 0.008 ) , respectively .


When data were analyzed separately for study site clusters , a post hoc analysis demonstrated that both SPN-804 dosages were significantly superior to placebo in median percent seizure reduction ( placebo : -13.3 % ; 1200 mg : -34.5 % , P = 0.02 ; 2400 mg : -52.7 % , P = 0.006 ) in the North American study site cluster .


A concentration-response analysis also supported a clinically meaningful effect for 1200 mg .


Adverse event types reflected the drug 's established profile .


Adverse event frequency was consistent with a pharmacokinetic profile in which SPN-804 produces lower peak plasma concentrations vs immediate-release OXC .


Once-daily dosing was not associated with any new safety signals .


Adjunctive once-daily SPN-804 improved seizure control in patients with inadequately controlled partial-onset seizures .


Adverse event occurrence and discontinuations due to adverse events suggest improved tolerability vs previously published data with immediate-release OXC .


Few studies examine the helpfulness and effectiveness of substance abuse treatment from the clients ' perspective .


The current secondary analysis examined the perceived helpfulness of substance abuse treatment components and its relationship to treatment outcomes among 387 Black and White adults participating in a multisite randomized clinical trial ( RCT ) of Motivational Enhancement Therapy .


Throughout the 16-week RCT , participants self-reported substance use .


Upon completion of treatment , participants completed a self-report measure assessing the perceived helpfulness of treatment components .


Black participants rated 9 out of 12 treatment components ( e.g. , `` learning skills that will help me cope with my problems '' ) as being more helpful than their White counterparts , even after controlling for age , gender , employment status , primary drug type , and treatment assignment .


However , perceived helpfulness ratings were not associated with substance use outcomes among Black or White participants .


Clients ' perceived helpfulness of treatment components is an important factor to consider in improving the delivery of substance abuse treatment , especially for Black adults .


To evaluate the direct effects of periodontal therapy in Chronic Obstructive Pulmonary Disease ( COPD ) patients with chronic periodontitis ( CP ) .


In a pilot randomized controlled trial , 60 COPD patients with CP were randomly assigned to receive scaling and root planing ( SRP ) treatment , supragingival scaling treatment , or oral hygiene instructions only with no periodontal treatment .


We evaluated their periodontal indexes , respiratory function , and COPD exacerbations at baseline , 6months , 1 , and 2years .


Compared with the control group , measurements of periodontal indexes were significantly improved in patients in two treatment groups at 6-month , 1-year , and 2-year follow-up ( all p < 0.05 ) .


Overall , the means of forced expiratory volume in the first second/forced vital capacity ( FEV1/FVC ) and FEV1 were significantly higher in the two therapy groups compared with the control group during the follow-up ( p < 0.05 ) .


In addition , the frequencies of COPD exacerbation were significantly lower in the two therapy groups than in the control group at 2-year follow-up ( p < 0.05 ) .


Our preliminary results from this pilot trial suggest that periodontal therapy in COPD patients with CP may improve lung function and decrease the frequency of COPD exacerbation .


Arterial punctures are important procedures performed by emergency physicians in the assessment of ill patients .


However , arterial punctures are painful and can create anxiety and needle phobia in patients .


The pain score of radial arterial punctures were compared between the insulin needle and the standard 23-gauge hypodermic needle .


In a randomized controlled crossover design , healthy volunteers were recruited to undergo bilateral radial arterial punctures .


They were assigned to receive either the insulin or the standard needle as the first puncture , using blocked randomization .


The primary outcome was the pain score measured on a 100-mm visual analogue scale ( VAS ) for pain , and secondary outcomes were rate of hemolysis , mean potassium values , and procedural complications immediately and 24 hours postprocedure .


Fifty healthy volunteers were included in the study .


The mean ( standard deviation ) VAS score in punctures with the insulin needle was lower than the standard needle ( 23 22 mm vs. 39 24 mm ; mean difference = -15 mm ; 95 % confidence interval = -22 mm to -7 mm ; p < 0.001 ) .


The rates of hemolysis and mean potassium value were greater in samples obtained using the insulin needle compared to the standard needle ( 31.3 % vs. 11.6 % , p = 0.035 ; and 4.6 0.7 mmol/L vs. 4.2 0.5 mmol/L , p = 0.002 ) .


Procedural complications were lower in punctures with the insulin needle both immediately postprocedure ( 0 % vs. 24 % ; p < 0.001 ) and at 24 hours postprocedure ( 5.4 % vs. 34.2 % ; p = 0.007 ) .


Arterial punctures using insulin needles cause less pain and fewer procedural complications compared to standard needles .


However , due to the higher rate of hemolysis , its use should be limited to conditions that do not require a concurrent potassium value in the same blood sample .


Remifentanil is widely used for monitored anesthesia care in spontaneously breathing patients .


However , the authors ' previous studies have shown that remifentanil induces subjective swallowing difficulties , which may increase the risk of aspiration .


Twenty-five healthy volunteers participated in a double-blind , randomized , crossover trial at the University Hospital in rebro , rebro , Sweden .


The volunteers were studied on two different occasions during which they received either remifentanil with an effect-site target concentration of 3 ng/ml or saline over 1 h.


A radionuclide tracer was infused simultaneously into the nasopharynx at a rate of 0.1 ml/min .


Aspiration was determined by lung scans , and subjective swallowing difficulties and grip strength were evaluated .


The primary outcome was the difference in occurrence of aspiration between remifentanil and placebo treatments .


The secondary outcomes were differences in swallowing difficulty and grip strength and the association between aspiration and swallowing difficulty .


During remifentanil and placebo infusion , 48 and 12 % of the volunteers aspirated , respectively , difference : 36 % ( 95 % CI , 10 to 62 % ) .


A similar significant difference was found for swallowing difficulties but not for the association between aspiration and swallowing .


No difference was found in grip strength between the two treatments .


Remifentanil infusion at concentrations used in monitored anesthesia care increases the incidence of aspiration .


However , the subjective swallowing difficulty induced by remifentanil is not indicative of the aspiration risk .


Vitamin D modulates the immune response and blocks induction of an interferon ( IFN ) signature by systemic lupus erythematosus ( SLE ) sera .


This study was undertaken to investigate the effects of vitamin D supplementation on the IFN signature in patients with SLE .


SLE patients ( n = 57 ) with stable , inactive disease , a serum 25-hydroxyvitamin D ( 25 [ OH ] D ) level 20 ng/ml , an elevated anti-double-stranded DNA antibody level , and an IFN signature ( as determined by measuring the expression levels of 3 IFN response genes ) were randomized into a 12-week double-blind , placebo-controlled trial of vitamin D3 at doses of 2,000 IU or 4,000 IU .


An IFN signature response was defined as a 50 % reduction in the expression of 1 of the 3 genes or a 25 % reduction in the expression of 2 of the 3 genes .


Disease activity , adverse events , and endocrine effects were assessed .


Baseline characteristics of the patients in the 3 treatment groups ( placebo , low-dose vitamin D3 , or high-dose vitamin D3 ) were similar .


Repletion of 25 ( OH ) D ( i.e. , levels 30 ng/ml ) was not observed in any of the patients who were receiving placebo , while repletion was observed in 16 of 33 patients receiving vitamin D3 .


The percentage of patients with an IFN signature response did not differ among the treatment groups .


Moreover , there was no difference in the percentage of patients with an IFN signature response between those who remained vitamin D deficient and those who demonstrated repletion of vitamin D. Modular microarray analysis of a subset of patients ( n = 40 ) did not reveal changes from baseline in any modules ( including the IFN-inducible module ) in any of the treatment groups , and no differences in expression were found between patients who demonstrated vitamin D repletion and patients who were persistently vitamin D deficient .


Vitamin D3 was well tolerated , and there were no safety concerns .


Vitamin D3 supplementation up to 4,000 IU daily was safe and well-tolerated but failed to diminish the IFN signature in vitamin D-deficient SLE patients .


Higher 25 ( OH ) D levels sustained for a longer duration may be required to affect immunologic outcomes .


Distal radius fractures are among the most common fractures seen in the hospital emergency department .


Of these , over 40 % are considered unstable and require some form of fixation .


In recent years with the advent of low profile plating , open reduction and internal fixation ( ORIF ) using volar plates has become the surgical treatment of choice in many hospitals .


However , it is currently unknown which plating system has the lowest complication rate and/or superior clinical and radiological outcomes following surgery .


Few studies have compared different types of plates , which may have various features , different plate and screw designs or may be manufactured from different materials ( for example , stainless steel or titanium ) .


This study will specifically investigate and compare the clinical and radiological outcomes and complication rates of two commonly used volar plating systems for fixation of distal radius fractures : one made from stainless steel ( Trimed Volar Plate , Trimed , California , USA ) and the other made from titanium ( Medartis Aptus Volar Plate , Medartis , Basel , Switzerland ) .


The primary aim of this study is to determine if there is a difference on the Patient Reported Wrist Evaluation six months following ORIF using a volar plate for adult patients with a distal radius fracture .


This study will implement a randomized prospective clinical trial study design evaluating the outcomes of two different types of volar plates : one plate manufactured from stainless steel ( Trimed Volar Plate ) and one plate manufactured from titanium ( Medartis Aptus Volar Plate ) .


The surgery will be performed at a major trauma hospital in Brisbane , Australia .


Outcome measures including function , adverse events , range of movement , strength , disability , radiological findings and health-related quality of life will be collected at 6 weeks , 3 , 6 , 12 and 24 months following surgery .


A parallel economic analysis will also be performed .


This randomized clinical trial is due to deliver results in December 2016 .


Results from this trial will contribute to the evidence on operative management of distal radius fractures and plate material type .


ACTRN12612000969864 .


To compare corneal sensation and self-reported dry eye symptoms after femtosecond-assisted LASIK with conventional versus inverted side cuts .


Prospective , randomized , eye-to-eye study .


A total of 120 eyes in 60 participants with myopia .


Fellow eyes were randomized to receive femtosecond-assisted LASIK with a conventional 70-degree side cut made with the 60 kHz IntraLase FS ( Abbott Medical Optics , Santa Ana , CA ) or an inverted 130-degree side cut made with the 150 kHz IntraLase iFS ( Abbott Medical Optics ) .


Cochet-Bonnet aesthesiometry ( Luneau Ophthalmologia , Chartes , France ) measured corneal sensation ( 60 mm = normal sensation ; < 60 mm = depressed sensation ) preoperatively and at postoperative months 1 , 3 , 6 , and 12 .


Participants also completed serial dry eye surveys using the same subscales ( frequency , severity , bothersome ) as the validated , Rasch-tested , linear-scaled Quality of Vision questionnaire .


Objective corneal sensation and self-reported light sensitivity , dryness , foreign body sensation , and pain/discomfort .


Preoperative corneal sensation as measured by mean Cochet-Bonnet aethesiometry was equal between the inverted and conventional side cut groups but was better in eyes with an inverted side cut compared with a conventional side cut at all postoperative months ( inverted vs. conventional : 1 month , 14.5 vs. 13.2 mm ; 3 months , 24.9 vs. 18.4 mm ; 6 months , 51.2 vs. 42.6 mm ; 12 months , 59.8 vs. 58.3 mm ; all P 0.02 ) .


None of the subjective dry eye parameters demonstrated statistically significant differences between the groups at any time point .


The LASIK flaps with an inverted side cut are associated with superior recovery of corneal sensation compared with flaps with a conventional side cut during the first postoperative year ; however , this may not translate to significant improvements in subjective dry eye symptoms .


This trial was designed to compare levonorgestrel intrauterine device ( LNG-IUD ) use at 1 year after delivery between women randomized to postplacental insertion at the time of cesarean delivery and delayed insertion 4-8 weeks after delivery .


This randomized controlled trial was conducted at two urban medical centers .


Eligible pregnant women with planned cesarean deliveries were randomized to immediate postplacental insertion during cesarean or delayed insertion after 4-8 weeks .


We used intention-to-treat analysis for the primary outcome of LNG-IUD use 12 months after delivery .


Forty-two women were randomized , 20 into the postplacental group and 22 in the delayed group .


Although confirmed use of the LNG-IUD 12 months after delivery was higher in the postplacental group ( 60.0 % vs. 40.9 % , p = .35 ) , this difference was not statistically significance .


Expulsion was significantly more common in the postplacental group ( 20.0 % vs. 0 % , p = .04 ) .


There were significant differences between the two sites in baseline population characteristics , follow-up and expulsion .


The trial did not answer the intended question as it was halted early due to slow enrollment .


Our results show higher expulsion after postplacental insertion compared to delayed insertion but suggest similar IUD use at 12 months .


Moreover , it provides valuable lessons regarding a randomized controlled trial of postplacental LNG-IUD placement due to the challenges of estimating effect size and the nature of the population who might benefit from immediate insertion .


Postplacental insertion of an IUD may improve use of highly effective contraception during the postpartum period .


While our results suggest higher expulsion after postplacental insertion compared to delayed insertion and similar IUD use at 12 months , our trial was insufficient to definitively test our hypothesis .


To investigate the effect of adding segmental epidural steroid injections ( SESIs ) to usual care compared with usual care alone on quality of life and cost utility in lumbosacral radicular syndrome ( LRS ) in general practice .


A pragmatic randomized controlled trial .


Results were analyzed using mixed models .


Primary care .


Patients ( N = 50 ) in the acute phase of LRS .


One epidural injection containing 80mg of triamcinolone in normal saline .


Back pain at 4 weeks after the start of the treatment .


Both groups experienced a significant increase in quality of life in ( especially ) the physical domains of the Medical Outcomes Study 36-Item Short-Form Health Survey .


The intervention group scored significantly better than the control group at certain time points in the physical domain .


The differences were small .


The cost-utility analysis showed that with a negligible loss of utility ( 3d in perfect health ) , societal costs ( 193,354 euros per quality-adjusted life year lost ) would be saved because of more productivity in the intervention group .


Although the beneficial effects of SESIs are small and the natural course of LRS is predominantly favorable , we think decision makers can consider implementing SESIs in daily practice with the purpose of saving resources .


Caution must be taken , and further research should be directed at identifying patient subgroups who might benefit from SESIs , with additional focus on ( costs of ) complications and adverse effects .


To test the hypothesis that a semi-quantitative echocardiographic calcium score ( eCS ) significantly correlates with cardiac calcium measured by coronary computed tomography angiography ( CCTA ) and , secondarily , severe coronary artery calcifications and stenosis .


This is a retrospective , observational study , conducted in a tertiary centre .


eCS was compared with CCTA scores of non-coronary cardiac calcium ( nCACS ) , coronary cardiac calcium ( CACS ) and number of diseased coronary vessels , in 141 subjects without known coronary artery disease ( CAD ) , who underwent both echocardiography and CCTA for clinical reasons .


Age , prevalence of hypertension and all measures of calcium ( eCS , nCACS and CACS ) differed significantly between the no-CAD and CAD subgroups .


eCS was positively correlated with nCACS ( Spearman rho = 0.64 , p < 0.0001 ) , CACS ( rho = 0.46 , p < 0.01 ) and weakly with the number of diseased coronary vessels ( rho = 0.28 , p < 0.05 ) .


eCS and nCACS had similar area under the curve ( AUC ) for the prediction of severe CACS ( 400 ) ( 0.77 , 95 % CI 0.68-0 .86 and 0.79 , 95 % CI 0.72-0 .88 ) or obstructive CAD ( 0.63 , 95 % CI 0.54-0 .72 and 0.63 , 95 % CI 0.55-0 .73 ) .


eCS , a calcium score easily obtainable during standard echocardiography , is moderately to strongly correlated with nCACS by CCTA .


The full eCS score correlates with nCACS better than its single components .


It correlates with CACS and predicts severe coronary calcification ( CACS > 400 ) , a known predictor of cardiovascular morbidity and mortality .


The eCS also predicts obstructive CAD , incrementally to age and clinical variables , although for this purpose CACS remains the most accurate score .


As young women from certain ethnic minority groups have reported less pursuit of the thin ideal and body dissatisfaction than European American young women we tested whether a dissonance-based prevention program designed to reduce thin-ideal internalization among women with body dissatisfaction is less effective for the former relative to the later groups .


We also tested whether intervention effects are larger when participants from minority groups worked with a facilitator matched versus not matched on ethnicity .


In Study 1 , 426 female undergraduates ( M age = 21.6 , SD = 5.6 ) were randomized to clinician-led Body Project groups or an educational control group .


In Study 2 , 189 female undergraduates were randomized to peer-led Body Project groups or a waitlist control condition .


Although there was some variation in risk factor scores across ethnic groups , ethnic minority participants did not demonstrate consistently higher or lower risk relative to European American participants .


Intervention effects did not significantly differ for participants from minority groups versus European American participants in either trial .


There was no evidence that effects were significantly larger when minority participants and facilitators were matched on ethnicity .


Results suggest that the Body Project is similarly effective for African American , Asian American , European American , and Hispanic female college students , and when participants and facilitators are matched or not on minority ethnicity status , implying that this prevention program can be broadly disseminated in this population .


There are no data regarding management and outcomes of major bleeding events in patients treated with oral factor Xa inhibitors .


Using data from ROCKET AF , we analysed the management and outcomes of major bleeding overall and according to the randomized treatment .


During a median follow-up of 1.9 years , 779 ( 5.5 % ) patients experienced major bleeding at a rate of 3.52 events/100 patient-years with a similar event rate in each arm ( n = 395 rivaroxaban vs. n = 384 warfarin ) .


The median number of transfused packed red blood cells ( PRBC ) per episode was similar in both arms [ 2 ( 25th , 75th : 2 , 4 ) units ] .


Overall , few transfusions of whole blood ( n = 14 ) , platelets ( n = 10 ) , or cryoprecipitate ( n = 2 ) were used .


Transfusion of fresh frozen plasma ( FFP ) was significantly less in the rivaroxaban arm ( n = 45 vs. n = 81 units ) after adjustment for covariates [ odds ratio ( OR ) 0.43 ( 95 % CI 0.29-0 .66 ) ; P < 0.0001 ] .


Prothrombin complex concentrates ( PCC ) were administered less in the rivaroxaban arm ( n = 4 vs. n = 9 ) .


Outcomes after major bleeding , including stroke or non-central nervous system embolism ( 4.7 % rivaroxaban vs. 5.4 % warfarin ; HR 0.89 ; 95 % CI 0.42-1 .88 ) and all-cause death ( 20.4 % rivaroxaban vs. 26.1 % warfarin ; HR 0.69 , 95 % CI 0.46-1 .04 ) were similar in patients treated with rivaroxaban and warfarin ( interaction P = 0.51 and 0.11 ) .


Among high-risk patients with atrial fibrillation who experienced major bleeding in ROCKET AF , the use of FFP and PCC was less among those allocated rivaroxaban compared with warfarin .


However , use of PRBCs and outcomes after bleeding were similar among patients randomized to rivaroxaban or to warfarin .


Remote ischemic preconditioning ( RIPC ) has been suggested to induce cardioprotection during cardiac surgery .


Maintaining proper atrial function is imperative in preventing arrhythmia and thrombus formation .


Mitochondria have been proposed as key targets in conveying RIPC mechanisms and effects .


MicroRNA ( miR ) is emerging as an important regulator of mitochondrial function , arrhythmia , and protection from ischemia and reperfusion .


This study aimed to evaluate the effect of RIPC on mitochondrial respiration and miR expression in human atrial tissue .


Sixty patients undergoing coronary artery bypass graft surgery were randomized to RIPC ( n = 30 ) or control ( n = 30 ) .


RIPC was performed preoperatively by inflating a blood pressure cuff on the upper arm to 200 mm Hg for 35 minutes , with 5 minutes reperfusion intervals .


Biopsies were obtained from the right atrial appendage before and after aortic cross-clamping .


Mitochondrial respiration was measured in situ and miR assessed by commercial miR array and quantitative reverse transcription polymerase chain reaction .


Postoperative atrial fibrillation occurrence was monitored by biotelemetry .


Maximal mitochondrial respiration was preserved throughout surgery after RIPC but significantly reduced ( -28 % ; P < 0.05 ) after aortic cross-clamping in control .


Incidence of postoperative atrial fibrillation was lower after RIPC versus control ( 14 % versus 50 % ; P < 0.01 ) .


Myocardial expression of miR-133a and miR-133b increased after aortic cross-clamping in both RIPC and control , whereas miR-1 was upregulated in control only .


MiR-338-3p expression was higher in RIPC versus control after aortic cross-clamping .


RIPC preserves mitochondrial respiration and prevents upregulation of miR-1 in the right atrium during coronary artery bypass graft .


http://www.clinicaltrials.gov .


Unique identifier : NCT01308138 .


Providing different programs of occupational health services in the same company is difficult .


We report the results of a parallel randomized trial for the employees of our company for visceral fat measurements and the effect of a weight loss support web system .


181 healthy employees with BMI over 23 who volunteered to participate in this study .


In a parallel randomized study , we divided them into 3 groups ( A , health guidance by occupational health staff with visceral fat measurements and a weight loss support web system ; B , health guidance by occupational health staff with a weight loss support web system ; C , without health guidance ( control ) ) by date of birth .


To assess the effects of guidance and support , we compared each group 's waist circumference ( WC ) , weight , and BMI , before and after the guidance .


We also conducted questionnaire surveys of eating behavior and life activities before and after the guidance to estimate the relationship between the intervention method used for each group and their behavioral modification .


150 employees ( 83 % ) finished this program .


Within 3 months , reduction in the outcome measures was largest in group A , and showed significant differences from the other two groups .


For many employees in group A , eating behavior factors improved markedly ; however , in the control group , there were no changes in eating behavior or daily living activities .


A parallel randomized trial involving the employees of our company was performed and we scientifically verified the effects of an occupational health programs .


Objective study of occupational health activities and measures were enabled by devising methods and procedures , e.g. , applying the waiting-list method for the control group .


This approach will lead to appropriate selection and precise implementation of evidence-based measures in occupational health in the future .


This paper reports long-term results of RTOG 9903 , to determine whether the addition of erythropoietin ( EPO ) would improve the outcomes of radiation therapy ( RT ) in mildly to moderately anemic patients with head and neck squamous cell carcinoma ( HNSCCa ) .


The trial included HNSCCa patients treated with definitive RT. .


Patients with stage III or IV disease received concomitant chemoradiation therapy or accelerated fractionation .


Pretreatment hemoglobin levels were required to be between 9.0 and 13.5 g/dL ( 12.5 g/dL for females ) .


EPO , 40,000 U , was administered weekly starting 7 to 10days before RT was initiated in the RT+EPO arm .


A total of 141 of 148 enrolled patients were evaluable .


The baseline median hemoglobin level was 12.1 g/dL .


In the RT+EPO arm , the mean hemoglobin level at 4weeks increased by 1.66 g/dL , whereas it decreased by 0.24 g/dL in the RT arm .


With a median follow-up of 7.95 years ( range : 1.66-10 .08 years ) for surviving patients and 3.33 years for all patients ( range : 0.03-10 .08 years ) , the 5-year estimate of local-regional failure was 46.2 % versus 39.4 % ( P = .42 ) , local-regional progression-free survival was 31.5 % versus 37.6 % ( P = .20 ) , and overall survival was 36.9 % versus 38.2 % ( P = .54 ) for the RT+EPO and RT arms , respectively .


Late toxicity was not different between the 2 arms .


This long-term analysis confirmed that despite the ability of EPO to raise hemoglobin levels in anemic patients with HNSCCa , it did not improve outcomes when added to RT. .


The possibility of a detrimental effect of EPO could not be ruled out .


To define protein molecular characteristics of tumor cells prior to , and immediately following , preoperative human epidermal growth factor receptor 2 ( HER2 ) - targeted therapy that correlate with pathologic complete response ( pCR ) or non response ( no pCR ) to preoperative HER2-directed therapy and chemotherapy .


This open-label , phase II study randomized patients with HER2-positive stage II or III invasive breast cancer to trastuzumab , lapatinib , or both , 2 weeks prior to and during chemotherapy with FEC75 for 4 courses ; then paclitaxel 80 mg/m2 weekly for 12 courses , then surgery .


Core needle biopsies were collected at baseline and after 2 weeks of anti-HER2 therapy prior to chemotherapy .


Data were correlated with pCR , defined as absence of invasive tumor in breast and lymph nodes .


Of 100 enrolled patients , the analysis population included those who had surgery and received 75 % chemotherapy ( 78 % [ n = 78 ] ) .


pCRs by arm are : trastuzumab ( n = 26 ) , 54 % [ n = 14 ] ; lapatinib ( n = 29 ) , 45 % [ n = 13 ] ; trastuzumab plus lapatinib ( n = 23 ) , 74 % [ n = 17 ] ) .


Paired biopsy specimens were available for 49 patients ( 63 % ) .


Tumor cells of patients with pCR in the trastuzumab or lapatinib treatment arms showed nonphosphorylated FOXO , phosphorylated Stat5 , and sparse signal-transduction protein network crosstalk representing different patterns of connections with PI3K and autophagy proteins compared with no pCR .


In this exploratory study , pCR with preoperative anti-HER2 therapy and chemotherapy correlated with the levels and phosphorylation status of specific baseline signal pathway proteins in tumor cells .


These data may provide candidate biomarkers to stratify initial treatment and potential combination therapies for future study .


Tissue preservation technology introduced here makes this procedure widely feasible .


ClinicalTrials.gov : NCT00524303 .


To investigate the feasibility and effectiveness of conducting two positive psychology interventions to improve mood and self-concept with survivors of traumatic brain injury ( TBI ) , within a neuro-rehabilitation hospital .


Ten patients with brain injury were randomly allocated to an intervention and control group .


The efficacy of the first intervention , ` three positive things in life ' was measured via Seligman 's Authentic Happiness Index ( AHI ) , at base-line , directly following the intervention and at the end of the 12-week group programme .


The second intervention , the ` Value in Action ( VIA ) signature strengths intervention ' was measured by the Head Injury Semantic Differential Scale ( HISDS ) at baseline and at the end of the group .


Compared to baseline and control group scores , the AHI index showed an increase in the intervention group 's happiness following the intervention and at the end of the 12-week programme , albeit the latter increase was non-significant .


The HISDS showed non-significant improvement in self-concept and reduction in polarization of the self in the present , future and past in the second intervention .


Anecdotal evidence revealed a clear improved mood following the interventions .


This study shows promising results for the effectiveness of Positive Psychology interventions and methods to improve feasibility when applying this treatment within a hospital setting .


The optimal use of various therapeutic combinations for moderate/severe chronic obstructive pulmonary disease ( COPD ) is unclear .


The GLISTEN trial compared the efficacy of two long-acting anti-muscarinic antagonists ( LAMA ) , when combined with an inhaled corticosteroid ( ICS ) and a long-acting 2 agonist ( LABA ) .


This randomised , blinded , placebo-controlled trial in moderate/severe COPD patients compared once-daily glycopyrronium ( GLY ) 50g , once-daily tiotropium ( TIO ) 18g or placebo ( PLA ) , when combined with salmeterol/fluticasone propionate ( SAL/FP ) 50/500g twice daily .


The primary objective was to determine the non-inferiority of GLY+SAL / FP versus TIO+SAL / FP on trough FEV1 after 12weeks .


An important secondary objective was whether addition of GLY to SAL/FP was better than SAL/FP alone .


773 patients ( mean FEV1 57.2 % predicted ) were randomised ; 84.9 % completed the trial .


At week 12 , GLY+SAL / FP demonstrated non-inferiority to TIO+SAL / FP for trough FEV1 : least square mean treatment difference ( LSMdiff ) -7 mL ( SE 17.4 ) with a lower limit for non-inferiority of -60 mL .


There was significant increase in week 12 trough FEV1 with GLY+SAL / FP versus PLA+SAL / FP ( LSMdiff 101mL , p < 0.001 ) .


At 12weeks , GLY+SAL / FP produced significant improvement in St George 's Respiratory Questionnaire total score versus PLA+SAL / FP ( LSMdiff -2.154 , p = 0.02 ) .


GLY+SAL / FP demonstrated significant rescue medication reduction versus PLA+SAL / FP ( LSMdiff -0.72 puffs/day , p < 0.001 ) .


Serious adverse events were similar for GLY+SAL / FP , TIO+SAL / FP and PLA+SAL / FP with an incidence of 5.8 % , 8.5 % and 5.8 % , respectively .


GLY+SAL / FP showed comparable improvements in lung function , health status and rescue medication to TIO+SAL / FP .


Importantly , addition of GLY to SAL/FP demonstrated significant improvements in lung function , health status and rescue medication compared to SAL/FP .


NCT01513460 .


There is a need for culturally relevant nutrition programs targeted to underserved cancer survivors .


Our aim was to examine the effect of a culturally based approach to dietary change on increasing fruit/vegetable ( F/V ) intake and decreasing fat intake among Hispanic breast cancer survivors .


Participants were randomized to Intervention and Control groups .


Diet recalls , detailed interviews , fasting blood , and anthropometric measures were collected at baseline , 3 , 6 , and 12 months .


Hispanic women ( n = 70 ) with stage 0 to III breast cancer who completed adjuvant treatment and lived in New York City were randomized between April 2011 and March 2012 .


The Intervention group ( n = 34 ) participated in Cocinar Para Su Salud !


, a culturally based nine-session ( 24 hours over 12 weeks ) intervention including nutrition education , cooking classes , and food-shopping field trips .


The Control group ( n = 36 ) received written dietary recommendations for breast cancer survivors .


Change at 6 months in daily F/V servings and percent calories from total fat were the main outcome measures .


Linear regression models adjusted for stratification factors and estimated marginal means were used to compare changes in diet from baseline to 3 and 6 months .


Baseline characteristics were the following : mean age 56.6 years ( standard deviation 9.7 years ) , mean time since diagnosis 3.4 years ( standard deviation 2.7 years ) , mean body mass index ( calculated as kg/m ) 30.9 ( standard deviation 6.0 ) , 62.9 % with annual household income $ 15,000 , mean daily servings of all F/V was 5.3 ( targeted F/V 3.7 servings excluding legumes/juices/starchy vegetables/fried foods ) , and 27.7 % of daily calories from fat .


More than 60 % in the Intervention group attended seven or more of nine classes , with overall study retention of 87 % retention at 6 months .


At month 6 , the Intervention group compared with Control group reported an increase in mean servings of F/V from baseline ( all F/V : +2.0 vs -0.1 ; P = 0.005 ; targeted F/V : +2.7 vs +0.5 ; P = 0.002 ) and a nonsignificant decrease in percent calories from fat ( -7.5 % vs -4.4 % ; P = 0.23 ) and weight ( -2.5 kg vs +3.8 kg ; P = 0.22 ) .


Cocinar Para Su Salud !


was effective at increasing short-term F/V intake in a diverse population of Hispanic breast cancer survivors .


Copeptin , a quantitative marker of endogenous stress , seems to provide incremental value in addition to cardiac troponin in the early rule-out of acute myocardial infarction ( AMI ) .


Prevalence , characteristics and outcome of acute chest pain patients with causes other than AMI and elevated copeptin are poorly understood .


A total of 984 consecutive patients with non-cardiac chest pain were selected from a prospective multicentre study of acute chest pain patients presenting to the emergency department .


Levels of copeptin were determined in a blinded fashion and considered elevated if above 13pmol/L ( the 97,5 th centile of healthy individuals ) .


The final diagnosis was adjudicated by two independent cardiologists .


Median duration of follow-up was 756days .


Elevated copeptin levels were seen in 215 patients ( 22 % ) .


In comparison to patients with normal copeptin levels , patients with elevated levels were older , had more pre-existing cardiac and non-cardiac disorders , more silent cardiomyocyte injury and increased haemodynamic stress as quantified by levels of high-sensitivity cardiac troponin T ( 9.6 ng/L ( 3.6-18 .3 ) vs 5.8 ng/L ( 2.9-9 .4 ) ) and B-type natriuretic peptide ( 75ng/L ( 37-187 ) vs 35ng/L ( 15-77 ) ) ( both p < 0.001 ) , more electrocardiographic abnormalities , more often an adjudicated diagnosis of gastroesophageal reflux or bronchitis/pneumonia and higher 2-year mortality ( HR 2.9 , 95 % CI 1.5 to 5.7 ) .


The increased mortality rate seemed to be largely explained by age and comorbidities .


Elevated levels of copeptin are present in about one in five patients with non-cardiac chest pain and are associated with aging , cardiac and non-cardiac comorbidities as well as mortality .


This study investigated the efficacy of low-level laser therapy ( LLLT ) for the management of temporomandibular joint ( TMJ ) osteoarthritis .


In a double-blind clinical trial , 20 patients with TMJ osteoarthritis were randomly divided into laser and placebo groups .


The patients in the laser group received irradiation from an 810 nm low-level laser ( Peak power 80 W , average power 50 mW , 1500 Hz , 1 micro s pulse width , 120 seconds , 6 J , 3.4 J/cm ( 2 ) per point ) , which was applied on four points around the TMJs and on painful muscles three times a week for 4 weeks .


In the placebo group , the treatment was the same as that in the laser group , but with laser simulation .


The patients were evaluated before laser therapy ( T1 ) , after 6 ( T2 ) and 12 ( T3 ) laser applications and 1 month after the last application ( T4 ) , and the amount of mouth opening and the pain intensity were recorded .


No significant differences were found in mouth opening either between the study groups or between the different evaluation times in each group ( P > 0.05 ) .


There was no significant difference in pain symptoms of the masticatory muscles and TMJ between the laser and the placebo groups ( P > 0.05 ) , but some significant within-group improvements were present for Visual Analogue Scale ( VAS ) scores of the body of the masseter and TMJ in both groups .


LLLT using the present laser parameters was no more effective than the placebo treatment for reducing pain and improving mouth opening in patients with TMJ osteoarthritis .


Hypoxemia secondary to reduced barometric pressure is a complication of ascent to altitude .


We designed a study to compare the reversal of hypobaric hypoxemia at 14,000 ft with continuous flow oxygen from a cylinder and pulsed dose oxygen from a portable concentrator .


There were 30 healthy volunteers who were randomized to one of three study groups , placed in an altitude chamber , and ascended to 14,000 ft. There were 10 subjects in each study group .


Subjects breathed room air for 10 min to induce hypoxemia .


Oxygen was then delivered via a nasal cannula from a cylinder at 1 , 2 , or 3 lpm of continuous flow for 10 min .


The subjects again breathed room air at altitude for 10 min and were then placed on pulsed dose oxygen and titrated to obtain the continuous flow Spo2 equivalent .


Spo2 , Etco2 , RR , HR , Hgb , and tissue oxygenation ( Sto2 ) were continuously recorded .


The 1-lpm group 's Spo2 range was 89-99 % .


The 2-lpm group 's Spo2 range was 95-98 % , and the 3-lpm group 's Spo2 range was 95-99 % .


The 2-lpm and 3-lpm flows were able to correct hypoxemia in every subject .


The mean pulsed dose required to achieve an equivalent Spo2 ranged from 36.8 ml 18.9 ml in the 1-lpm arm , and 102.4 ml 53.8 in the 3-lpm arm .


Portable oxygen concentrators using pulsed dose technology corrected hypoxemia in every subject .


Oxygen concentrators may be an alternative to liquid oxygen or cylinders for use during aeromedical evacuation .


Breast cancer is the most common cancer and the leading cause of death among Latinas in the United States .


The Multi-level Intervention to Increase Participation in Mammography Screening study ( Fortaleza Latina ! )


is a partnership among research institutions , a Latino-serving community-based primary care clinic organization , and a cancer treatment center .


The study will assess the efficacy of a clinic - and patient-level program to increase breast cancer screening among Latinas in Western Washington .


The intervention is a multi-level breast cancer screening program in four participating primary care clinics .


The study is a parallel randomized controlled trial of 600 Latino women aged 42-74 who are non-compliant with breast cancer screening guidelines .


Participants will be randomized within clinic using block randomization to : ( 1 ) a control arm ( usual care ) ; and ( 2 ) a theory-based counseling program consisting of a ` promotora ' or community health worker-led home-based intervention to encourage breast cancer screening .


At the clinic-level , two clinics will offer additional mammography services provided by a mobile mammography unit operated by the Seattle Cancer Care Alliance .


The primary endpoint is the rate of mammography uptake over the 1-year follow-up period .


This multi-level intervention aims to raise rates of participation in breast cancer screening among Latino women .


If effective , the program may improve rates of early detection of breast cancer in Latino women .


Clinicaltrials.gov


NCT02010008 .


To determine the perceived risk of type 2 diabetes in a sample of healthy middle-aged adults and examine the association between perceived risk and modelled risk , clinical risk factors , and psychological factors theorised to be antecedents of behaviour change .


An exploratory , cross-sectional analysis of perceived risk of type 2 diabetes ( framed according to time and in comparison with peers ) was conducted using baseline data collected from 569 participants of the Diabetes Risk Communication Trial ( Cambridgeshire , UK ) .


Type 2 diabetes risk factors were measured during a health assessment and the Framingham Offspring Diabetes Risk Score was used to model risk .


Questionnaires assessed psychological factors including anxiety , diabetes-related worry , behavioural intentions , and other theory-based antecedents of behaviour change .


Multivariable regression analyses were used to examine associations between perceived risk and potential correlates .


Participants with a high perceived risk were at higher risk according to the Framingham Offspring Diabetes Risk Score ( p < 0.001 ) .


Higher perceived risk was observed in those with a higher body fat percentage , lower self-rated health , higher diabetes-related worry , and lower self-efficacy for adhering to governmental recommendations for physical activity ( all p < 0.001 ) .


The framing of perceived risk according to time and in comparison with peers did not influence these results .


High perceived risk of type 2 diabetes is associated with higher risk of developing the disease , and a decreased likelihood of engagement in risk-reducing health behaviours .


Risk communication interventions should target high-risk individuals with messages about the effectiveness of prevention strategies .


Although multivitamins are widely used , there are limited prospective studies investigating their association with both long - and short-term risk of cardiovascular disease ( CVD ) .


The objective was to investigate how multivitamin use is associated with the long - and short-term risk of CVD .


A prospective cohort study was conducted of 37,193 women from the Women 's Health Study aged 45 y and free of CVD and cancer at baseline who were followed for an average of 16.2 y.


At baseline , women self-reported a wide range of lifestyle , clinical , and dietary factors .


Women were categorized into 1 ) no current use and 2 ) current use of multivitamins .


Duration and updated measures over the course of the follow-up to address short-term effects were also considered .


Women were followed for major CVD events , including myocardial infarction ( MI ) , stroke , and CVD death .


During the follow-up , 1493 incident cases of CVD [ defined as myocardial infarction ( MI ) , stroke , and CVD death ] occurred .


In multivariable analyses , multivitamin use compared with no use was not associated with major CVD events ( HR : 1.01 ; 95 % CI : 0.89 , 1.15 ) , MI ( HR : 1.04 ; 95 % CI : 0.84 , 1.27 ) , stroke ( HR : 0.99 ; 95 % CI : 0.83 , 1.18 ) , or CVD death ( HR : 1.10 ; 95 % CI : 0.84 , 1.45 ) .


A nonsignificant inverse association was observed between baseline multivitamin use and major CVD events among women aged 70 y ( P-interaction = 0.04 ) and those consuming < 3 servings/d of fruit and vegetables ( P-interaction = 0.01 ) .


When updating information on multivitamin use during the course of follow-up , no associations were observed for major CVD events ( HR : 0.91 ; 95 % CI : 0.82 , 1.02 ) , MI ( HR : 0.89 ; 95 % CI : 0.74 , 1.06 ) , stroke ( HR : 0.91 ; 95 % CI : 0.78 , 1.06 ) , and CVD death ( HR : 0.91 ; 95 % CI : 0.71 , 1.16 ) .


In this study of middle-aged and elderly women , neither baseline nor time-varying multivitamin use was associated with the long-term risk of major CVD events , MI , stroke , cardiac revascularizations , or CVD death .


Additional studies are needed to clarify the role of multivitamins on CVD .


To compare the immediate effects of electroacupuncture and manual acupuncture on pain , mobility and muscle strength in patients with knee osteoarthritis .


Sixty patients with knee osteoarthritis , with a pain intensity of 2 on the pain Numerical Rating Scale , were included .


The patients were randomised into two groups : manual acupuncture and electroacupuncture .


Pain intensity , degree of dysfunction ( Timed Up and Go ( TUG ) test ) , maximal voluntary isometric contraction and pressure pain threshold were assessed before and after a single session of manual acupuncture or electroacupuncture treatments .


Both groups showed a significant reduction in pain intensity ( p < 0.001 ) and time to run the TUG test after the acupuncture treatment ( p = 0.005 for the manual acupuncture group and p = 0.002 for the electroacupuncture group ) .


There were no differences between the groups regarding pain intensity ( p = 0.25 ) , TUG test ( p = 0.70 ) , maximum voluntary isometric contraction ( p = 0.43 ) or pressure pain threshold ( p = 0.27 ) .


This study found no difference between the immediate effects of a single session of manual acupuncture and electroacupuncture on pain , muscle strength and mobility in patients with knee osteoarthritis .


RBR-9TCN2X .


The duration between first symptom and a cancer diagnosis is important because , if shortened , may lead to earlier stage diagnosis and improved cancer outcomes .


We have previously developed a tool to measure this duration in newly-diagnosed patients .


In this two-phase study , we aimed further improve our tool and to conduct a trial comparing levels of anxiety between two modes of delivery : self-completed versus researcher-administered .


In phase 1 , ten patients completed the modified tool and participated in cognitive debrief interviews .


In phase 2 , we undertook a Randomised Controlled Trial ( RCT ) of the revised tool ( Cancer Symptom Interval Measure ( C-SIM ) ) in three hospitals for 11 different cancers .


Respondents were invited to provide either exact or estimated dates of first noticing symptoms and presenting them to primary care .


The primary outcome was anxiety related to delivery mode , with completeness of recording as a secondary outcome .


Dates from a subset of patients were compared with GP records .


After analysis of phase 1 interviews , the wording and format were improved .


In phase 2 , 201 patients were randomised ( 93 self-complete and 108 researcher-complete ) .


Anxiety scores were significantly lower in the researcher-completed group , with a mean rank of 83.5 ; compared with the self-completed group , with a mean rank of 104.0 ( Mann-Whitney U = 3152 , p = 0.007 ) .


Completeness of data was significantly better in the researcher-completed group , with no statistically significant difference in time taken to complete the tool between the two groups .


When comparing the dates in the patient questionnaires with those in the GP records , there was evidence in the records of a consultation on the same date or within a proscribed time window for 32/37 ( 86 % ) consultations ; for estimated dates there was evidence for 23/37 consultations ( 62 % ) .


We have developed and tested a tool for collecting patient-reported data relating to appraisal intervals , help-seeking intervals , and diagnostic intervals in the cancer diagnostic pathway for 11 separate cancers , and provided evidence of its acceptability , feasibility and validity .


This is a useful tool to use in descriptive and epidemiological studies of cancer diagnostic journeys , and causes less anxiety if administered by a researcher .


Radiofrequency ablation of atrial fibrillation has been associated with some risk of thromboembolic events .


Previous studies showed that preventive short episodes of forearm ischemia ( remote ischemic preconditioning [ IPC ] ) reduce exercise-induced platelet reactivity .


In this study , we assessed whether remote IPC has any effect on platelet activation induced by radiofrequency ablation of atrial fibrillation .


We randomized 19 patients ( age , 54.711 years ; 17 male ) undergoing radiofrequency catheter ablation of paroxysmal atrial fibrillation to receive remote IPC or sham intermittent forearm ischemia ( control subjects ) before the procedure .


Blood venous samples were collected before and after remote IPC/sham ischemia , at the end of the ablation procedure , and 24 hours later .


Platelet activation and reactivity were assessed by flow cytometry by measuring monocyte-platelet aggregate formation , platelet CD41 in the monocyte-platelet aggregate gate , and platelet CD41 and CD62 in the platelet gate in the absence and presence of ADP stimulation .


At baseline , there were no differences between groups in platelet variables .


Radiofrequency ablation induced platelet activation in both groups , which persisted after 24 hours .


However , compared with control subjects , remote IPC patients showed a lower increase in all platelet variables , including monocyte-platelet aggregate formation ( P < 0.0001 ) , CD41 in the monocyte-platelet aggregate gate ( P = 0.002 ) , and CD41 ( P < 0.0001 ) and CD62 ( P = 0.002 ) in the platelet gate .


Compared with control subjects , remote IPC was also associated with a significantly lower ADP-induced increase in all platelet markers .


Our data show that remote IPC before radiofrequency catheter ablation for paroxysmal atrial fibrillation significantly reduces the increased platelet activation and reactivity associated with the procedure .


To analyse if social capital modifies the effect of educational intervention of home visitors on mobility disability .


Earlier studies have found that educational intervention of home visitors has a positive effect of older peoples ' functional decline , but how social capital might modify this effect is still unknown .


We used the Danish Intervention Study on Preventive Home Visits - a prospective cohort study including 2863 75-year-olds and 1171 80-year-olds in 34 Danish municipalities - to analyse the modifying effect of different aspects of social capital on the effect of educational intervention of home visitors on functional decline .


The three measures of social capital ( bonding , bridging , and linking ) were measured at contextual level .


Data was analysed with multivariate linear regression model using generalised estimating equations to account for repeated measurements .


We found that 80-year-olds living in municipalities with high bonding ( B = 0.089 , p = 0.0279 ) and high linking ( B = 0.0929 ; p = 0.0217 ) had significant better mobility disability in average at 3-year follow up if their municipality had received intervention .


With the unique design of the Danish Intervention Study on Preventive Home Visits and with theory-based measures of social capital that distinguish between three aspects of social capital with focus on older people , this study contributes to the literature about the role of social capital for interventions on mobility disability .


To investigate the effect of preoperative psychological intervention on alleviating negative emotions in patients undergoing emergent ocular trauma surgery .


A total of 100 patients undergoing emergent ocular trauma surgery were selected using convenience sampling and randomly divided into control ( n = 49 ) and experimental ( n = 51 ) groups .


Patients in the control group received conventional nursing and their counterparts in the observation group were treated with individualized psychological interventions including psychological support , relaxation training , and humanistic care based on conventional nursing care .


Self-rating anxiety scale ( SAS ) , self-rating depression scale ( SDS ) , and fear visual analog scale ( FVAS ) scores were statistically compared between the two groups .


The scores of SAS , SDS , and FAVS were significantly lower in the experimental group than in the control group ( all P < 0.001 ) .


Comprehensive psychological intervention effectively eliminates negative emotions in patients undergoing emergent ocular trauma surgery and accelerates their physical and mental recovery .


Vascular endothelial growth factor ( VEGF ) - mediated angiogenesis plays an important role in non-small cell lung cancer ( NSCLC ) .


Ramucirumab is a human immunoglobulin G1 monoclonal antibody that inhibits VEGF receptor 2 .


This phase 2 study investigated ramucirumab in combination with first-line pemetrexed and platinum chemotherapy in advanced/metastatic NSCLC .


Eligible stage IV nonsquamous NSCLC patients with no prior chemotherapy for metastatic disease were randomized 1:1 to pemetrexed and carboplatin ( or cisplatin ) or ramucirumab ( 10 mg/kg ) plus pemetrexed and carboplatin ( or cisplatin ) once every 3 weeks .


Treatment was given for 4 to 6 cycles , and this was followed by a maintenance phase with pemetrexed or ramucirumab and pemetrexed .


The primary endpoint was progression-free survival ( PFS ) with a sample size of sufficient power to detect an increase from 7 to 10.4 months .


From October 2010 to October 2011 , 140 patients were randomized ( pemetrexed-platinum arm , 71 ; ramucirumab-pemetrexed-platinum arm , 69 ) , and most baseline characteristics were similar for the 2 treatment arms .


The median PFS was 5.6 months for the pemetrexed-platinum arm and 7.2 months for the ramucirumab-pemetrexed-platinum arm ( hazard ratio , 0.75 ; P = .132 ) .


The objective response rates were 38.0 % and 49.3 % for the pemetrexed-platinum and ramucirumab-pemetrexed-platinum arms , respectively ( P = .180 ) .


The disease control rate was 70.4 % for the pemetrexed-platinum arm and 85.5 % for the ramucirumab-pemetrexed-platinum arm ( P = .032 ) .


The grade 3 or higher adverse events occurring in 10 % or more of patients were thrombocytopenia , neutropenia , fatigue , anemia , nausea , back pain , and hypertension .


The primary endpoint of significant prolongation of PFS was not met ; however , ramucirumab showed evidence of clinical activity in combination with pemetrexed and platinum in nonsquamous NSCLC patients .


The addition of ramucirumab to pemetrexed and platinum did not result in new or unexpected safety findings .


To combine multiple Heidelberg Retina Tomograph ( HRT ) parameters using the Random Forests classifier to diagnose glaucoma , both in highly and physiologically myopic ( highly myopic ) eyes and emmetropic eyes .


Subjects consisted of healthy subjects and age-matched patients with open-angle glaucoma in emmetropic ( -1.0 to +1.0 diopters [ D ] , 63 and 59 subjects , respectively ) and highly myopic eyes ( -10.0 to -5.0 D , 56 and 64 subjects , respectively ) .


First , area under the receiver operating characteristic curve ( AUC ) was derived using 84 HRT global and sectorial parameters and the representative HRT raw parameter ( largest AUC ) was identified .


Then , the Random Forests method was carried out using age , refractive error , and 84 HRT parameters .


The AUCs were also derived using the following : ( 1 ) Frederick S. Mikelberg discriminant function ( FSM ) score , ( 2 ) Reinhard O.W. Burk discriminant function ( RB ) score , ( 3 ) Moorfields regression analysis ( MRA ) score , and ( 4 ) glaucoma probability score ( GPS ) .


In combined emmetropic and highly myopic population , AUC with Random Forests method ( 0.96 ) was significantly larger than AUCs with the representative HRT raw parameter ( vertical cup-to-disc ratio [ global ] , 0.89 ) , FSM ( 0.90 ) , RB ( 0.83 ) , MRA ( 0.87 ) , and GPS ( 0.81 ) ( P < 0.001 ) .


Similarly , AUC with the Random Forests method was significantly ( P < 0.05 ) larger than these other parameters , both in emmetropic and highly myopic groups .


Also , the Random Forests method achieved partial AUCs above 80 % / 90 % significantly ( P < 0.05 ) larger than any other HRT parameters in all populations .


Evaluating multiple HRT parameters using the Random Forests classifier provided accurate diagnosis of glaucoma , both in emmetropic and highly myopic eyes .


Dengue virus is the most serious mosquito-borne viral threat to public health and no vaccines or antiviral therapies are approved for dengue fever .


The tetravalent DENVax vaccine contains a molecularly characterised live attenuated dengue serotype-2 virus ( DENVax-2 ) and three recombinant vaccine viruses expressing the prM and E structural genes for serotypes 1 , 3 , and 4 in the DENVax-2 genetic backbone .


We aimed to assess the safety and immunogenicity of tetravalent DENVax formulations .


We undertook a randomised , double-blind , phase 1 , dose-escalation trial between Oct 11 , 2011 , and Nov 9 , 2011 , in the Rionegro , Antioquia , Colombia .


The first cohort of participants ( aged 18-45 years ) were randomly assigned centrally , via block randomisation , to receive a low-dose formulation of DENvax , or placebo , by either subcutaneous or intradermal administration .


After a safety assessment , participants were randomly assigned to receive a high-dose DENVax formulation , or placebo , by subcutaneous or intradermal administration .


Group assignment was not masked from study pharmacists , but allocation was concealed from participants , nurses , and investigators .


Primary endpoints were frequency and severity of injection-site and systemic reactions within 28 days of each vaccination .


Secondary endpoints were the immunogenicity of DENVax against all four dengue virus serotypes , and the viraemia due to each of the four vaccine components after immunisation .


Analysis was by intention to treat for safety and per protocol for immunogenicity .


Because of the small sample size , no detailed comparison of adverse event rates were warranted .


The trial is registered with ClinicalTrials.gov , number NCT01224639 .


We randomly assigned 96 patients to one of the four study groups : 40 participants ( 42 % ) received low-dose vaccine and eight participants ( 8 % ) received placebo in the low-dose groups ; 39 participants ( 41 % ) received high-dose vaccine , with nine ( 9 % ) participants assigned to receive placebo .


Both formulations were well tolerated with mostly mild and transient local or systemic reactions .


No clinically meaningful differences were recorded in the overall incidence of local and systemic adverse events between patients in the vaccine and placebo groups ; 68 ( 86 % ) of 79 participants in the vaccine groups had solicited systemic adverse events compared with 13 ( 76 % ) of 17 of those in the placebo groups .


By contrast , 67 participants ( 85 % ) in the vaccine group had local solicited reactions compared with five ( 29 % ) participants in the placebo group .


Immunisation with either high-dose or low-dose DENVax formulations induced neutralising antibody responses to all four dengue virus serotypes ; 30 days after the second dose , 47 ( 62 % ) of 76 participants given vaccine seroconverted to all four serotypes and 73 ( 96 % ) participants seroconverted to three or more dengue viruses .


Infectious DENVax viruses were detected in only ten ( 25 % ) of 40 participants in the low-dose group and 13 ( 33 % ) of 39 participants in the high-dose group .


Our findings emphasise the acceptable tolerability and immunogenicity of the tetravalent DENVax formulations in healthy , flavivirus-naive adults .


Further clinical testing of DENVax in different age groups and in dengue-endemic areas is warranted .


Takeda Vaccines .


To study the role of mometasone furoate aqueous nasal spray for the management of adenoidal hypertrophy in children with more than 50 per cent obstruction , and to assess its impact on change in quality of life .


A prospective , randomised , double-blind , interventional placebo-controlled study was conducted .


A total of 100 children aged 2-12 years completed treatment and follow up .


The symptoms and degree of obstruction were evaluated by nasopharyngoscopy conducted pre-treatment and 24 weeks post-treatment .


Subjects received mometasone furoate nasal spray at a daily dose of 200g for 8 weeks , followed by a dose of 200g on alternate days for 16 weeks .


RESULTS were compared with those of a matched control group who were given saline nasal spray .


With mometasone treatment , there was an 89.8 per cent reduction in clinical symptom score , and the degree of obstruction dropped from 87 to 72 per cent ( p < 0.0001 ) .


A statistically significant change in quality of life scores was seen in patients treated with the mometasone nasal spray ( score change of 37.47 ) as compared with those given saline nasal spray ( score change of 11.25 ) ( p = 0.0001 ) .


Mometasone nasal spray appears to be effective in treating children with obstructive adenoids .


To observe the effect of Ningdong Granule ( NG ) on serum levels of interleukin-12 ( IL-12 ) and tumor necrosis factor-alpha ( TNF-alpha ) of children patients with Tourette 's syndrome ( TS ) .


Totally 90 TS children patients were randomly assigned to the NG group , the NG + Tiapride group ( abbreviated as the combined treatment group ) , and the Tiapride group , 30 in each group .


Besides , another 30 healthy children were recruited as the healthy control group .


Patients in the NG group were treated with NG ( consisting of all gastrodia rhizome , Codonopsis pilosula , Ophiopogon japonicus , white peony root , Rhinocerotidae , oyster , earthworm , licorice root , etc. ) , one dose daily , administered by dissolving it in boiled water , taken in two portions in the morning and in the evening respectively .


Patients in the Tiapride group took Tiapride Tablet , 50 -100 mg each time , twice daily .


The dosage was adjusted according to individual difference and changes of pathogenic conditions .


The maximal dosage was 300 mg per day .


Those in the combined treatment group were treated with equal dose of NG and Tiapride Tablet in combination .


The treatment course was 3 months for all .


Changes of pathogenic condition before and after treatment were assessed by Yale global tic severity scale ( YGTSS ) .


Serum levels of IL-12 and TNF-alpha were detected by enzyme-labeled immunosorbent assay ( ELISA ) before and after treatment .


( 1 ) The total effective rate of the NG group , the combined treatment group , and the Tiapride group was 79.3 % , 83.3 % , and 67.9 % , respectively .


It was the lowest in the Tiapride group ( P < 0.05 ) .


It was significantly higher in the combined treatment group than in the NG group ( P < 0.05 ) .


( 2 ) The post-treatment YGTSS score was obviously lower in each group after treatment than before treatment ( P < 0.05 ) .


The posttreatment YGTSS score was obviously lower in the NG group and the combined treatment group than in the Tiapride group ( P < 0.05 ) , but with no statistical difference between the fromer two groups ( P > 0.05 ) .


( 3 ) Compared with the healthy control group before treatment , serum levels of IL-12 and TNF-alpha ( pg/mL ) were 124.95 + / - 22.78 and 209.52 + / - 21.69 in the NG group , 126.14 + / - 25.65 and 208.97 + / - 22.46 in the combined treatment group , 123.00 + / - 24.26 and 205.10 + / - 26.16 in the Tiapride group , being higher than those in the healthy control group ( 64.56 + / - 27.59 and 78.13 + / - 33.42 ; P < 0.05 ) .


After treatment , serum levels of of IL-12 and TNF-alpha were 104.67 + / - 16.84 and 183.01 + / - 24.95 in the NG group , 109.04 + / - 16.81 and 179.87 + / - 23.45 in the combined treatment group , significantly lower than before treatment ( P < 0.05 ) .


But there was no statistical difference in serum levels of IL-12 or TNF-alpha in the Tiapride group between before treatment ( 123.00 + / - 24.26 and 205.10 + / - 26.16 ) and after treatment ( 117.75 + / - 16.79 and 199.76 + / - 33.21 ; P > 0.05 ) .


NG could modulate abnormal serum levels of IL-12 and TNF-alpha in TS children patients , which might be one of its pharmacodynamic mechanisms for treating TS .


To evaluate the effect of certolizumab pegol ( CZP ) on productivity outside and within the home , and on participation in family , social and leisure activities in adult patients with psoriatic arthritis ( PsA ) .


RAPID-PsA ( NCT01087788 ) is a phase 3 , double-blind , placebo-controlled trial .


409 patients with active PsA were randomised 1:1:1 to placebo , CZP 200mg every 2weeks ( Q2W ) or CZP 400mg every 4weeks ( Q4W ) .


The arthritis-specific Work Productivity Survey ( WPS ) assessed the impact of PsA on paid work and household productivity , and participation in social activities during the preceding month .


WPS responses were compared between treatment arms using a non-parametric bootstrap-t method .


At baseline , 56.6 % , 60.1 % and 61.5 % of placebo , CZP 200mg Q2W and CZP 400mg Q4W patients were employed .


By week 24 , employed CZP patients reported an average of 1.0-1 .8 and 3.0-3 .9 fewer days of absenteeism and presenteeism , respectively , per month compared with 1.0 and 0.3 fewer days for placebo patients ( p < 0.05 ) .


Within the home , by week 24 , CZP patients reported an average of 3.0-3 .5 household work days gained per month versus 1.0 day for placebo ( p < 0.05 ) .


CZP patients also reported fewer days with reduced household productivity or days lost for participation in family , social and leisure activities .


Improvements with CZP were seen as early as week 4 and continued to week 24 .


CZP treatment significantly improved productivity at paid work and within the home , and resulted in greater participation in social activities for PsA patients .


NCT01087788 .


Two double-blind , randomized studies were conducted to assess the tolerability , pharmacokinetics and pharmacodynamics of oral TA-8995 , a new cholesteryl ester transfer protein ( CETP ) inhibitor , in healthy subjects .


Study 1 : Subjects received single doses of TA-8995 or placebo ( fasted ) .


Doses were 5 , 10 , 25 , 50 ( fed/fasted ) , 100 and 150mg ( Caucasian males , 18-55years ) , 25mg ( Caucasian males , > 65years and Caucasian females , 18-55years ) , 25 , 50 , 100 and 150mg ( Japanese males , 18-55years ) .


Study 2 : Caucasian males ( 18-55years ) received 1 , 2.5 , 10 or 25mg once daily TA-8995 or placebo for 21-28days .


Blood and urine for pharmacokinetics and/or pharmacodynamics were collected .


Tolerability was assessed by adverse events , vital signs , electrocardiograms and laboratory safety tests .


Peak TA-8995 concentrations occurred approximately 4h post-dose .


Mean half-lives ranged from 81 to 166h , without an obvious dose relationship .


Exposure increased less than proportionally to dose .


TA-8995 was not excreted in urine .


Following 2.5 to 25mg once daily dosing , TA-8995 demonstrated nearly complete inhibition of CETP activity ( 92-99 % ) , increased high density lipoprotein-cholesterol ( HDL-C ) by 96 to 140 % and decreased low density liporotein-cholesterol ( LDL-C ) by 40 % to 53 % .


There were dose-related increases in apolipoproteins A-1 and E , HDL2-C and HDL3-C , and decreases in apolipoprotein B and lipoprotein A.


There was no evidence of significant effects of age , gender , ethnicity or food on pharmacokinetics or pharmacodynamics .


All doses were well tolerated .


TA-8995 is a potent CETP inhibitor and warrants further investigation .


Limited data exist regarding the efficacy of metoclopramide in the treatment of intractable hiccups .


This study aimed to assess the feasibility efficacy of metoclopramide in the treatment of patients with intractable hiccups .


A total of 36 patients with intractable hiccups was randomly assigned to arm A ( n = 18 ) or arm B ( n = 18 ) in a multicentre , double-blind , randomised , controlled pilot study .


Participants in arm A received 10-mg metoclopramide thrice daily for 15 days , whereas those assigned to arm B received 10-mg placebo thrice daily for 15 days .


The primary outcome measure was total efficacy against hiccups ( including cessation and improvement of hiccups ) .


Secondary outcome measures included a comparison of overall efficacy and adverse events between the two arms .


Of the 36 patients enrolled , 34 participants completed the study .


The total efficacy was higher in arm A than in arm B ( relative risk , 2.75 ; 95 % confidence interval : 1.09-6 .94 , P = 0.03 ) .


Furthermore , comparison between the two arms revealed that overall efficacy was higher in arm A than that in arm B ( P < 0.05 ) .


No serious adverse events related to the treatment were documented in either arm .


The most common adverse events occurring in patients in arm A included fatigue , upset mood and dizziness .


Metoclopramide appears to be a promising candidate for the treatment of patients with intractable hiccups , with mild adverse events .


However , further clinical trials are required to confirm these results .


Plain packaging requires tobacco products to be sold in packs with a standard shape , method of opening and colour , leaving the brand name in a standard font and location .


We ran a randomised controlled trial to investigate the impact of plain packaging on smoking behaviour and attitudes .


In a parallel group randomised trial design , 128 daily smokers smoked cigarettes from their usual UK brand , or a plain Australian brand that was closely matched to their usual UK brand for 24 hours .


Primary outcomes were number of cigarettes smoked and volume of smoke inhaled per cigarette .


Secondary outcomes were self-reported ratings of motivation to quit , cigarette taste , experience of using the pack , experience of smoking , attributes of the pack , perceptions of the health warning , changes in smoking behaviour , and views on plain packaging .


There was no evidence that pack type had an effect on either of the primary measures ( ps > 0.279 ) .


However , smokers using plain cigarette packs rated the experience of using the pack more negatively ( -0.52 , 95 % CI -0.82 to -0.22 , p = 0.001 ) , rated the pack attributes more negatively ( -1.59 , 95 % CI -1.80 to -1.39 , p < 0.001 ) , and rated the health warning as more impactful ( +0.51 , 95 % CI 0.24 to 0.78 , p < 0.001 ) .


Plain cigarette packs reduce ratings of the experience of using the cigarette pack , and ratings of the pack attributes , and increase the self-perceived impact of the health warning , but do not change smoking behaviour , at least in the short term .


Current Controlled Trials ISRCTN52982308 .


Registered 27 June 2013 .


Until now , working memory training has not reached sufficient evidence as effective treatment for ADHD core symptoms in children with ADHD ; for young children with ADHD , no studies are available .


To this end , a triple-blind , randomized , placebo-controlled study was designed to assess the efficacy of Cogmed Working Memory Training ( CWMT ) in young children with ADHD .


Fifty-one children ( 5-7years ) with a DSM-IV-TR diagnosis of ADHD ( without current psychotropic medication ) were randomly assigned to the active ( adaptive ) or placebo ( nonadaptive ) training condition for 25 sessions during 5 weeks .


The compliance criterion ( > 20 sessions ) was met for 47 children .


The primary outcome measure concerned the core behavioural symptoms of ADHD , measured with the ADHD Rating Scale IV ( ADHD-RS ) .


Secondary outcome measures were neurocognitive functioning , daily executive functioning , and global clinical functioning .


The influence of the increase in difficulty level ( Index-Improvement ) for the treatment group was also analysed .


Clinical trial registration information - ` Working Memory Training in Young ADHD Children ' ; www.clinicaltrials.gov ; NCT00819611 .


A significant improvement in favour of the active condition was found on a verbal working memory task ( p = .041 ; adapted Digit Span WISC-III , backward condition ) .


However , it did not survive correction for multiple testing .


No significant treatment effect on any of the primary or other secondary outcome measurements was found .


The Index-Improvement significantly contributed to ADHD-RS and the Behavior Rating Inventory of Executive Function , both rated by the teacher , but revealed no significant group difference .


This study failed to find robust evidence for benefits of CMWT over the placebo training on behavioural symptoms , neurocognitive , daily executive , and global clinical functioning in young children with ADHD .


In our previous randomised controlled trial ( RCT ) , we have shown in preterm babies ( PBs ) < 30weeks gestation that CeasIng Cpap At standarD criteriA ( CICADA ( method 1 ) ) compared with cycling off continuous positive airway pressure ( CPAP ) gradually ( method 2 ) or cycling off CPAP gradually with low flow air/oxygen during periods off CPAP ( method 3 ) reduces CPAP cessation time in PBs < 30weeks gestation .


This retrospective study reviewed weight gain , time to reach full feeds and time to cease caffeine in PBs previously enrolled in the RCT .


Data were collected from 162 of the 177 PBs , and there was no significant difference in the projected weight gain between the three methods .


Based on intention to treat , the time taken to reach full feeds for all three methods showed no significant difference .


However , post hoc analysis showed the CICADA method compared with cycling off gradually just failed significance ( 30.31.6 vs 31.12.4 ( weeks corrected gestational age ( Wks CGASD ) ) , p = 0.077 ) .


Analysis of time to cease caffeine showed there was a significant difference between the methods with PBs randomised to the CICADA method compared with the cycling off method ceasing caffeine almost a week earlier ( 33.62.4 vs 34.52.8 ( Wks CGASD ) , p = 0.02 ) .


This retrospective study provides evidence to substantiate the optimum method of ceasing CPAP ; the CICADA method , does not adversely affect weight gain , time to reach full feeds and may reduce time to cease caffeine in PBs < 30weeks gestation .


The effect of intracoronary adenosine ( ADO ) on ST-segment elevation myocardial infarction ( STEMI ) size and adverse remodeling is not well established .


In a double-blind trial , 201 patients with STEMI were randomized to receive percutaneous coronary intervention ( PCI ) within 6 hours of symptom onset , 4.5 mg ADO or saline immediately prior to reperfusion .


Primary end-point : percentage of total myocardial necrotic mass by cardiac magnetic resonance ( CMR ) 2-7 days post-reperfusion .


Secondary end-points : changes in left ventricular volumes and ejection fraction ( LVEF ) at baseline and at 6 months .


Baseline CMR could not be performed in 20 patients .


Overall , no significant differences were observed between ADO and placebo regarding infarct size ( 20.8 % vs. 22.5 % ; p = 0.40 ) .


However , infarct size was significantly reduced ( 19.4 % vs. 25.7 % ; p for interaction = 0.031 ) in those with ischemia duration below the median ( 200 min ) .


CMR at 6 months , performed in 138 patients , did not show statistically significant differences between groups in the rate of LVEF increase ( 3.3 units ( SD 9.6 ) in ADO group vs. 1.5 units ( SD 9 ) in placebo group ; p = 0.25 ) .


In the subgroup analysis , among patients with ischemia time below 200 min , the increase in LVEF was slightly higher with ADO ( 3.59 % vs. 0.43 % ; p for interaction = 0.06 ) .


Although our study failed to demonstrate that intracoronary administration of ADO prior to PCI limits infarct size , in patients receiving early PCI ADO might enhance myocardial salvage and has a favorable effect on LVEF evolution , which may help to reconcile apparently contradictory results of previous studies .


http://clinicaltrials.gov ( NCT00781404 ) .


To evaluate aripiprazole once-monthly ( AOM ) , a long-acting injectable suspension of aripiprazole , as acute treatment in patients with schizophrenia ( DSM-IV-TR ) .


Adults experiencing an acute psychotic episode were randomized to 12 weeks of double-blind treatment with AOM 400 mg or placebo ( October 2012-August 2013 ) .


The primary efficacy outcome was change from baseline to endpoint ( week 10 ) in Positive and Negative Syndrome Scale ( PANSS ) total score .


The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale ( CGI-S ) score .


Secondary efficacy outcomes included change from baseline in PANSS positive and negative subscale and Personal and Social Performance Scale ( PSP ) scores .


The study took place from October 2012 through August 2013 .


Patients ( N = 340 ; 79 % male , 66 % black ) were randomized to AOM ( n = 168 ) or placebo ( n = 172 ) .


Least squares ( LS ) mean change from baseline to endpoint ( week 10 ) favored AOM versus placebo in PANSS total ( treatment difference , -15.1 [ 95 % CI , -19.4 to -10.8 ] ; P < .0001 ) and CGI-S ( treatment difference , -0.8 [ 95 % CI , -1.1 to -0.6 ] ; P < .0001 ) scores , as it did at all other timepoints through 12 weeks ( all P .0005 ) .


LS mean change from baseline in PANSS positive and negative subscale and PSP scores favored AOM versus placebo ( P < .0001 ) .


Common ( > 10 % ) treatment-emergent adverse events ( AOM vs. placebo ) were increased weight ( 16.8 % vs 7.0 % ) , headache ( 14.4 % vs. 16.3 % ) , and akathisia ( 11.4 % vs 3.5 % ) .


Symptoms and functioning improved with AOM 400 mg versus placebo in patients with acute schizophrenia , with acceptable safety and tolerability .


These data suggest that AOM 400 mg is a viable treatment option for patients experiencing an acute schizophrenia episode .


ClinicalTrials.gov identifier : NCT01663532 .


This study investigated the short-term effects of Kinesio taping ( KT ) on various types of pain , active range of motion ( AROM ) , and proprioception in patients with knee osteoarthritis .


Forty-six older participants ( mean [ SD ] , 57.9 [ 4.4 ] yrs ) with osteoarthritis were randomly allocated to two groups : the KT group or the placebo-KT group .


Taping with tension ( KT application ) or without tension ( placebo-KT application ) was applied to the quadriceps of the participants in both groups .


Before and after intervention , pain intensity was measured using a visual analog scale at rest and during walking , and pressure pain thresholds ( PPTs ) were assessed using an algometer in the quadriceps and the tibialis anterior .


In addition , pain-free AROM and proprioception were measured .


The KT group showed attenuation of pain during walking ( effect size [ ES ] , 1.97 ) , PPT in the quadriceps ( ES , 2.58 ) , and PPT in the tibialis anterior ( ES , 2.45 ) .


This group also showed significantly improved AROM ( ES , 2.01 ) and proprioception ( ES , 1.73-1 .89 ; P < 0.05 ) .


However , the placebo-KT group did not show significant changes in pain , AROM , or proprioception .


There were significant differences between the two groups in pain during walking and PPT .


In addition , pain during walking showed a significant correlation with AROM and proprioception , and a significant correlation was found between PPT and AROM .


These results demonstrated that KT application with proper tension to the quadriceps effectively attenuates various types of pain and improves AROM and proprioception in osteoarthritis patients .


Thus , KT may be a suitable intervention to improve pain , AROM , and proprioception in patients with osteoarthritis in clinics .


The literature on the relationship of depressive symptoms and stress hormones after cancer diagnosis has been mixed , with some studies showing a relationship and other studies showing none .


Time since diagnosis may explain these contradictory findings .


This study examined the relationship of depressive symptoms to stress hormones in patients with breast cancer using 12-month longitudinal data .


Patients with Stage II or III breast cancer ( n = 227 ) were assessed every 4 months from diagnosis/surgery to 12 months .


They completed the Centers for Epidemiological Studies Depression Scale ( CES-D ) Iowa Short Form and the Perceived Stress Scale and blood samples were obtained to measure stress hormones ( i.e. , cortisol , adrenocorticotropin hormone , norepinephrine , and epinephrine ) .