During nutrition counseling , the WEP group sessions included activities to encourage increased water intake , reduced SSB intake , and substitution of water for SSBs .


Repeated 24-h dietary recalls , anthropometric measurements , and fasting blood samples were collected at baseline and at 3 , 6 , and 9 mo. .


The Markov-Monte Carlo method was used for multiple imputation ; separate mixed-effects models tested each outcome .


An intent-to-treat ( ITT ) analysis indicated that the WEP group increased water intake and decreased SSB intake significantly over time , but there were no differences in plasma TG concentrations between groups at the end of the intervention ( WEP at baseline : 155 2.10 mg/dL ; WEP at 9 mo : 149 2.80 mg/dL ; EP at baseline : 150 1.90 mg/dL ; EP at 9 mo : 161 2.70 mg/dL ; P for mean comparisons at 9 mo = 0.10 ) .


Secondary analyses showed significant effects on plasma TGs ( change from baseline to 9 mo : WEP , -28.9 7.7 mg/dL ; EP , 8.5 10.9 mg/dL ; P = 0.03 ) and metabolic syndrome ( MetS ) prevalence at 9 mo ( WEP : 18.1 % ; EP : 37.7 % ; P = 0.02 ) among obese participants .


Providing water and nutritional counseling was effective in increasing water intake and in partially decreasing SSB intake .


We found no effect on plasma TGs , weight , and other cardiometabolic risks in the ITT analysis , although the intervention lowered plasma TGs and MetS prevalence among obese participants .


Further studies are warranted .


This trial was registered at http://www.clinicaltrials.gov as NCT01245010 .


To measure the costs of a polypill strategy and compare them with those of usual care in people with established cardiovascular disease ( CVD ) or at similarly high cardiovascular risk .


A within-trial cost analysis of polypill-based care versus usual care with separate medications , using data from the Kanyini Guidelines Adherence with the Polypill ( GAP ) trial and linked health service and medication administrative claims data .


Kanyini GAP participants who consented to Australian Medicare record access .


Mean health service and pharmaceutical expenditure per patient per year , estimated with generalised linear models .


Costs during the trial ( randomisation January 2010 - May 2012 , median follow-up 19 months , maximum follow-up 36 months ) were inflated to 2012 costs .


Our analysis showed a statistically significantly lower mean pharmaceutical expenditure of $ 989 ( 95 % CI , $ 648 - $ 1331 ) per patient per year in the polypill arm compared with usual care ( P < 0.001 ; adjusted , excluding polypill cost ) .


No significant difference was shown in health service expenditure .


This study provides evidence of significant cost savings to the taxpayer and Australian Government through the introduction of a CVD polypill strategy .


The savings will be less now than during the trial due to subsequent reductions in the costs of usual care .


Nonetheless , given the prevalence of CVD in Australia , the introduction of this polypill could increase considerably the efficiency of health care expenditure in Australia .


Australian New Zealand Clinical Trials Registry ACTRN126080005833347 .


Fingolimod has shown reductions in clinical and MRI disease activity in patients with relapsing-remitting multiple sclerosis .


We further assessed the efficacy and safety of fingolimod in such patients .


We did this placebo-controlled , double-blind phase 3 study predominantly in the USA ( 101 of 117 centres ) .


Using a computer-generated sequence , we randomly allocated eligible patients-those aged 18-55 years with relapsing-remitting multiple sclerosis-to receive fingolimod 05 mg , fingolimod 125 mg , or placebo orally once daily ( 1:1:1 ; stratified by study centre ) .


On Nov 12 , 2009 , all patients assigned to fingolimod 125 mg were switched to the 05 mg dose in a blinded manner after a review of data from other phase 3 trials and recommendation from the data and safety monitoring board , but were analysed as being in the 125 mg group in the primary outcome analysis .


Our primary endpoint was annualised relapse rate at month 24 , analysed by intention to treat .


Secondary endpoints included percentage brain volume change ( PBVC ) from baseline and time-to-disability-progression confirmed at 3 months .


This trial is registered with ClinicalTrilals.gov , number NCT00355134 .


Between June 30 , 2006 , and March 4 , 2009 , we enrolled and randomly allocated 1083 patients : 370 to fingolimod 125 mg , 358 to fingolimod 05 mg , and 355 to placebo .


Mean annualised relapse rate was 040 ( 95 % CI 034-048 ) in patients given placebo and 021 ( 017-025 ) in patients given fingolimod 05 mg : rate ratio 052 ( 95 % CI 040-066 ; p < 00001 ) , corresponding to a reduction of 48 % with fingolimod 05 mg versus placebo .


Mean PBVC was -086 ( SD 122 ) for fingolimod 05 mg versus -128 ( 150 ) for placebo ( treatment difference -041 , 95 % CI -062 to -020 ; p = 00002 ) .


We recorded no statistically significant between-group difference in confirmed disability progression ( hazard rate 083 with fingolimod 05 mg vs placebo ; 95 % CI 061-112 ; p = 0227 ) .


Fingolimod 05 mg caused more of the following adverse events versus placebo : lymphopenia ( 27 [ 8 % ] patients vs 0 patients ) , increased alanine aminotransferase ( 29 [ 8 % ] vs six [ 2 % ] ) , herpes zoster infection ( nine [ 3 % ] vs three [ 1 % ] ) , hypertension ( 32 [ 9 % ] vs 11 [ 3 % ] ) , first-dose bradycardia ( five [ 1 % ] vs one [ < 05 % ] ) , and first-degree atrioventricular block ( 17 [ 5 % ] vs seven [ 2 % ] ) .


53 ( 15 % ) of 358 patients given fingolimod 05 mg and 45 ( 13 % ) of 355 patients given placebo had serious adverse events over 24 months , which included basal-cell carcinoma ( ten [ 3 % ] patients vs two [ 1 % ] patients ) , macular oedema ( three [ 1 % ] vs two [ 1 % ] ) , infections ( 11 [ 3 % ] vs four [ 1 % ] ) , and neoplasms ( 13 [ 4 % ] vs eight [ 2 % ] ) .


Our findings expand knowledge of the safety profile of fingolimod and strengthen evidence for its beneficial effects on relapse rates in patients with relapsing-remitting multiple sclerosis .


We saw no effect of fingolimod on disability progression .


Our findings substantiate the beneficial profile of fingolimod as a disease-modifying agent in the management of patients with relapsing-remitting multiple sclerosis .


Novartis Pharma AG .


To compare the efficacy of heart-shaped intrauterine balloon and intrauterine contraceptive device ( IUD ) in the prevention of adhesion reformation after hysteroscopic adhesiolysis .


Prospective , randomized , controlled trial .


University hospital .


A total of 201 women with Asherman syndrome .


Women were randomized to having either a heart-shaped intrauterine balloon or an IUD fitted after hysteroscopic adhesiolysis .


The devices were removed after 7days .


A second-look hysteroscopy was carried out 1 to 2months after the surgery .


Incidence of adhesion reformation and reduction of adhesion score before and after surgery .


Initially 201 cases were recruited ; 39 cases dropped out , resulting in 82 cases in the balloon group and 80 cases in IUD group .


The age , menstrual characteristics , pregnancy history , and American Fertility Society score before surgery were comparable between the two groups .


The median adhesion score reduction ( balloon group , 7 ; IUD group , 7 ) and the adhesion reformation rate ( balloon group , 30 % ; IUD group , 35 % ) were not significantly different between the two groups .


The heart-shaped intrauterine balloon and IUD are of similar efficacy in the prevention of adhesion reformation after hysteroscopic adhesiolysis for Asherman syndrome .


ISRCTN 69690272 .


Heterogeneous clinical presentation and gender differences were reported in Charcot-Marie-Tooth disease type 1A ( CMT1A ) .


This report examined demographic and clinical data collected during a randomised controlled trial , to describe the clinical spectrum of a large and well-defined cohort of CMT1A patients .


Among the 189 symptomatic patients screened , three patients ( 1.6 % ) reported first symptoms in the upper limbs , which may be misleading when establishing the clinical diagnosis .


The quality of life ( QoL ) of patients was significantly deteriorated compared to the standard population , and slightly better compared to multiple sclerosis patients .


According to the literature , patients reported several disorders which may be associated with CMT1A , including auditory dysfunction ( 7.9 % ) , Carpal Tunnel Syndrome ( CTS ) ( 7.9 % ) or sleep apnoea ( 4.2 % ) .


Compared to available data , we reported more patients with CTS and fewer patients with sleep apnoea .


Women were more affected by CTS than men ( 11 % and 2.8 % , respectively ) .


Women also reported an earlier onset of symptoms than men ( 8.69.5 years and 13.114 years , respectively ) , higher deterioration of their QoL and higher disability of their upper limb , assessed by Overall Neuropathy Limitation Scale ( p = 0.023 ) .


This information will be useful for better understanding of this disease and for designing future clinical studies .


Olive oil polyphenols have shown protective effects on cardiovascular risk factors .


Their consumption decreased oxidative stress biomarkers and improved some features of the lipid profile .


However , their effects on LDL concentrations in plasma and LDL atherogenicity have not yet been elucidated .


Our objective was to assess whether the consumption of olive oil polyphenols could decrease LDL concentrations [ measured as apolipoprotein B-100 ( apo B-100 ) concentrations and the total number of LDL particles ] and atherogenicity ( the number of small LDL particles and LDL oxidizability ) in humans .


The study was a randomized , cross-over controlled trial in 25 healthy European men , aged 20-59 y , in the context of the EUROLIVE ( Effect of Olive Oil Consumption on Oxidative Damage in European Populations ) study .


Volunteers ingested 25 mL/d raw low-polyphenol-content olive oil ( LPCOO ; 366 mg/kg ) or high-polyphenol-content olive oil ( HPCOO ; 2.7 mg/kg ) for 3 wk .


Interventions were preceded by 2-wk washout periods .


Effects of olive oil polyphenols on plasma LDL concentrations and atherogenicity were determined in the sample of 25 men .


Effects on lipoprotein lipase ( LPL ) gene expression were assessed in another sample of 18 men from the EUROLIVE study .


Plasma apo B-100 concentrations and the number of total and small LDL particles decreased ( mean SD : by 5.94 % 16.6 % , 11.9 % 12.0 % , and 15.3 % 35.1 % , respectively ) from baseline after the HPCOO intervention .


These changes differed significantly from those after the LPCOO intervention , which resulted in significant increases of 6.39 % 16.6 % , 4.73 % 22.0 % , and 13.6 % 36.4 % from baseline ( P < 0.03 ) .


LDL oxidation lag time increased by 5.0 % 10.3 % from baseline after the HPCOO intervention , which was significantly different only relative to preintervention values ( P = 0.038 ) .


LPL gene expression tended to increase by 26 % from baseline after the HPCOO intervention ( P = 0.08 ) and did not change after the LPCOO intervention .


The consumption of olive oil polyphenols decreased plasma LDL concentrations and LDL atherogenicity in healthy young men .


This trial was registered at www.controlled-trials.com as ISRCTN09220811 .


Hepatitis B virus ( HBV ) reactivation is a serious complication for patients with lymphoma treated with rituximab-containing chemotherapies , despite lamivudine prophylaxis treatment .


An optimal prophylactic antiviral protocol has not been determined .


To compare the efficacy of entecavir and lamivudine in preventing HBV reactivation in patients seropositive for the hepatitis B surface antigen with untreated diffuse large B-cell lymphoma receiving chemotherapy treatment with rituximab , cyclophosphamide , doxorubicin , vincristine , and prednisone ( R-CHOP ) .


Randomized , open-label , phase 3 study conducted from February 2008 through December 2012 at 10 medical centers in China .


This study was a substudy of a parent study designed to compare a 3-week with a 2-week R-CHOP chemotherapy regimen for untreated diffuse large B-cell lymphoma .


Patients enrolled in the parent study who were seropositive for the hepatitis B surface antigen and had normal liver function , serum HBV DNA levels of less than 103 copies/mL , and no prior antiviral therapy were randomized to entecavir ( n = 61 ) or lamivudine ( n = 60 ) .


Daily entecavir ( 0.5 mg ) or lamivudine ( 100 mg ) beginning 1 week before the initiation of R-CHOP treatment to 6 months after completion of chemotherapy .


The primary efficacy end point was the incidence of HBV-related hepatitis .


The secondary end points included rates of HBV reactivation , chemotherapy disruption due to hepatitis , and treatment-related adverse events .


There were 121 patients randomly assigned to receive entecavir ( n = 61 ) or lamivudine ( n = 60 ) .


The date of last patient follow-up was May 25 , 2013 .


The rates were significantly lower for the entecavir group vs the lamivudine group for HBV-related hepatitis ( 0 % vs 13.3 % , respectively ; difference between groups , 13.3 % [ 95 % CI , 4.7 % to 21.9 % ] ; P = .003 ) , HBV reactivation ( 6.6 % vs 30 % ; difference , 23.4 % [ 95 % CI , 10.2 % to 36.6 % ] ; P = .001 ) , and chemotherapy disruption ( 1.6 % vs 18.3 % ; difference , 16.7 % [ 95 % CI , 6.4 % to 27.0 % ] ; P = .002 ) .


Of the 61 patients in the entecavir group , 15 ( 24.6 % ) experienced treatment-related adverse events .


Of 60 patients in the lamivudine group , 18 ( 30 % ) experienced treatment-related adverse events ( difference between entecavir and lamivudine groups , 5.4 % [ 95 % CI , -10.5 % to 21.3 % ] ; P = .50 ) .


Among patients seropositive for the hepatitis B surface antigen with diffuse large B-cell lymphoma undergoing R-CHOP chemotherapy , the addition of entecavir compared with lamivudine resulted in a lower incidence of HBV-related hepatitis and HBV reactivation .


If replicated , these findings support the use of entecavir in these patients .


clinicaltrials.gov Identifier : NCT01793844 ; Chinese Clinical Trial Registry Identifier : CTR-TRC-11001687 .


Propofol ( PRO ) and dexmedetomidine ( DEX ) are commonly used to produce anesthesia and sedation for routine MRI procedures .


Children with complex conditions often require much lengthy MRI for multi-body-part scans with frequent scanner coil changes and patient body reposition .


This study compared PRO and DEX techniques on outcomes for the particular MRI setting with longer than 1 h duration .


95 children , aged from 1 to 7 years , scheduled for MRI > 75 min were randomly assigned to PRO or DEX group .


After induced with sevoflurane , a loading dose of PRO ( 2 mgkg ( -1 ) ) was administrated and followed by continuous infusion ( 200 gkg ( -1 ) min ( -1 ) ) ; a loading dose of DEX ( 2 gkg ( -1 ) ) was administrated and followed by continuous infusion ( 2 gkg ( -1 ) h ( -1 ) ) .


Patients received O ( 2 ) by nasal cannula .


The observed outcomes were times for induction , MRI , emergence , and recovery , and total time ( induction to discharge ) ; MRI pauses from patient movement ; incidence of technique failure and critical events ; emergence and behavior in postanesthesia care unit ( PACU ) ; parental satisfaction ; and arterial pressure ( BP ) and heart rate ( HR ) during anesthesia .


PRO compared with DEX showed significantly less time for anesthesia induction ( 16.3 versus 24.2 min ) , emergence ( 21.2 versus 39.9 min ) , PACU ( 35.7 versus 62.5 min ) , and total time ( 135 versus 173 min ) ( all P < 0.001 ) .


There were significantly fewer pauses during MRI and lower failure rate to complete MRI in PRO versus DEX ( 0.22 versus 0.81 , P = 0.01 and 1 versus 15 , P < 0.001 ) , less behavioral disturbances in PACU , and higher parental satisfaction in PRO versus DEX ( P < 0.01 ) .


There were no critical events in either group : In PRO , mean BP during MRI ( from 52 8 to 58 mmHg ) was significantly less than before anesthesia ( 80 12 mmHg ) , while HR remained relatively constant ( range of 97-103 ) at its baseline of 108 21 , but in DEX , mean BP remained unchanged ( from 76 12 to 78 15 ) during anesthesia compared with before anesthesia ( 79 14 mmHg ) , while HR decreased ( 74 16 to 78 15 ) during anesthesia from its baseline ( 102 17 ) .


For children undergoing lengthy multicomponent MRI , the propofol technique yielded overall better outcomes than the dexmedetomedine technique in terms of timeliness , PACU emergence characteristics , and parental satisfaction .


Both metformin and acarbose are recommended monotherapy and add-on therapy in type 2 diabetes mellitus ( T2DM ) .


A fixed-dose combination ( FDC ) of acarbose and metformin has been developed to reduce pill burden and potentially improve compliance .


The current study investigated the bioequivalence of the acarbose/metformin FDC compared with the individual agents administered simultaneously ( loose combination ) .


Secondary endpoints were the safety and tolerability of the FDC and the potential for drug-drug interactions between acarbose and metformin .


A single-centre , randomized , open-label , four-period crossover study was conducted in healthy male Korean subjects aged 18-45years .


Following one-period balanced Williams design , participants were randomized to receive four single oral treatments on different study days separated by 7days ' washout .


Treatments were as follows : ( i ) acarbose/metformin 50/500mg FDC ( test ) ; ( ii ) acarbose 50mg and metformin 500mg as loose combination ( reference ) ; ( iii ) acarbose 50mg ; and ( iv ) metformin 500mg .


Serial blood samples were taken for glucose and insulin levels for 4h after a sucrose load on the day before and day of study drug administration .


Additionally , serial blood samples were taken for analysis of metformin levels for 24h after each drug containing metformin .


The area under the curve for 4h post-test ( AUC0-4h ) and the maximal serum concentration ( Cmax ) of plasma glucose and serum insulin were primary pharmacodynamic ( PD ) parameters , and Cmax , AUC0-last and AUC for metformin levels were primary pharmacokinetic ( PK ) parameters .


The bioequivalence of the FDC to the loose combination was considered established if the 90 % confidence intervals ( CIs ) of the baseline-adjusted PD parameter ratios ( test vs. reference ) for plasma glucose and the PK parameter ratios for metformin fell completely within current acceptance limits ( 08-125 ) .


Thirty-three of 40 randomized subjects completed the study ; five withdrew consent and two discontinued because of adverse events ( AEs ) .


The 24-h plasma concentration-time curves of metformin and the 4-h plasma glucose-time curves after acarbose/metformin FDC ( test ) and acarbose + metformin loose combination ( reference ) were almost superimposable .


The geometric least squares ( LS ) mean of the RatioAUC and RatioCmax for plasma glucose after the FDC vs. loose combination , and the LS mean of the ratios in metformin AUC , AUC0-last and Cmax were close to unity , and the 90 % CI of all these parameters fell within the predefined equivalence range of 08-125 , confirming bioequivalence .


The metformin AUC was reduced by 26 % and Cmax by 34 % after acarbose + metformin compared with metformin alone .


Eight subjects ( 200 % ) reported AEs , but all were mild , and most were gastrointestinal , as expected for these agents .


The incidence of AEs was not higher with the combinations vs. monotherapy .


These data demonstrate that the acarbose/metformin FDC is bioequivalent to the loose combination of these agents .


Although acarbose slightly reduced the bioavailability of metformin , the accumulated evidence of the efficacy of this combination implies that this is clinically irrelevant .


The observed AE profile was consistent with the established knowledge on the safety of the two drugs .


The purpose of this study was to assess the in vitro P2Y12 receptor inhibitory effects of cangrelor on platelets from patients on maintenance prasugrel therapy treated with 2 reloading dose regimens .


Despite its more potent and rapid antiplatelet effects compared with clopidogrel , recent studies have shown variability in prasugrel-mediated P2Y12 receptor inhibition , particularly in high-risk settings .


Cangrelor is a potent intravenous P2Y12 receptor inhibitor .


A total of 60 patients with coronary artery disease on maintenance prasugrel ( 10 mg/day ) therapy were randomized to a 30 - or 60-mg reload of prasugrel .


The platelet reactivity index ( PRI ) , as assessed by whole-blood vasodilator-stimulated phosphoprotein , was measured with and without in vitro incubation of cangrelor ( 500 nM ) at baseline , and at 1 and 4 h after reload .


In the absence of cangrelor , prasugrel reloading reduced PRI ( p < 0.001 for both doses ) , although a 60-mg reload had greater platelet inhibition compared with a 30-mg reload at 4 h ( p = 0.001 ) .


Cangrelor was associated with a reduction in PRI values during the overall study time course in patients reloaded with 30 mg ( p = 0.001 ) and 60 mg ( p < 0.001 ) of prasugrel .


In patients reloaded with 30 mg prasugrel , cangrelor decreased PRI at each time point ( baseline , p < 0.001 ; 1 h , p = 0.013 ; 4 h , p = 0.001 ) .


In patients reloaded with 60 mg prasugrel , cangrelor decreased PRI at baseline ( p < 0.001 ) and 1 h ( p = 0.002 ) ; levels of platelet reactivity comparable to those achieved with cangrelor were observed only at 4 h ( p = 0.325 ) .


The intergroup comparisons with cangrelor were not significant at any time point .


In patients on maintenance prasugrel therapy exposed to a reloading dose ( 30 or 60 mg ) of prasugrel , in vitro cangrelor is associated with further platelet P2Y12 receptor inhibitory effects .


Point of care testing for C-reactive protein ( CRP ) has shown promise as a measure to reduce unnecessary antibiotic prescribing in respiratory tract infections ( RTI ) , but its use in primary care is still controversial .


We aimed to evaluate the effect of CRP testing on the prescription of antibiotics , referral for radiography , and the outcome of patients in general practice with acute cough/RTI .


An open-cluster randomized clinical trial was conducted , with CRP testing performed in the intervention group .


Antibiotic prescribing and referral for radiography were the main outcome measures .


A total of 179 patients were included : 101 in the intervention group and 78 in the control group .


The two groups were similar in clinical characteristics .


In the intervention group , the antibiotic prescribing rate was 37.6 % , which was significantly lower than that in the control group ( 58.9 % ) ( P = 0.006 ) .


Referral for chest X-ray was also significantly lower in the intervention group ( 55.4 % ) than in the control group ( 75.6 % ) ( P = 0.004 ) .


The recovery rate , as recorded by the GPs , was 92.9 % and 93.6 % in the intervention and control groups , respectively .


The study showed that CRP testing in patients with acute cough/RTI may reduce antibiotic prescribing and referral for radiography , probably without compromising recovery .


The trial was registered in the ClinicalTrials.gov Protocol Registration System ( identification number : NCT01794819 ) .


This study tested the effect of beginning treatment with a speech-generating device ( SGD ) in the context of a blended , adaptive treatment design for improving spontaneous , communicative utterances in school-aged , minimally verbal children with autism .


A total of 61 minimally verbal children with autism , aged 5 to 8 years , were randomized to a blended developmental/behavioral intervention ( JASP+EMT ) with or without the augmentation of a SGD for 6 months with a 3-month follow-up .


The intervention consisted of 2 stages .


In stage 1 , all children received 2 sessions per week for 3 months .


Stage 2 intervention was adapted ( by increased sessions or adding the SGD ) based on the child 's early response .


The primary outcome was the total number of spontaneous communicative utterances ; secondary measures were the total number of novel words and total comments from a natural language sample .


Primary aim results found improvements in spontaneous communicative utterances , novel words , and comments that all favored the blended behavioral intervention that began by including an SGD ( JASP+EMT+SGD ) as opposed to spoken words alone ( JASP+EMT ) .


Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better posttreatment outcomes .


Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel , blended intervention that focuses on joint engagement and play skills and incorporates an SGD .


Future studies should further explore the tailoring design used in this study to better understand children 's response to treatment .


Clinical trial registration information-Developmental and Augmented Intervention for Facilitating Expressive Language ( CCNIA ) ; http://clinicaltrials.gov/; NCT01013545 .


The purpose of this study was to refine a commercial car driving simulation for occupational research .


As the effects of ethanol on driving behavior are well established , we choose alcohol as a test compound to investigate the performance of subjects during simulation .


We programmed a night driving scenario consisting of monotonous highway and a rural road on a Foerst F10-P driving simulator .


Twenty healthy men , 19-30 years , participated in a pilot study .


Subjects were screened for simulator sickness , followed by training on the simulator one hour in total .


Experiments were performed in the morning on a separate day .


Participants were randomized into either an alcoholized or a control group .


All subjects drove two courses consisting of highway and rural road and were sober for the first course .


During a 1 h break the ethanol group drank an alcoholic beverage to yield 0.06 % blood alcohol concentration ( BAC ) .


Generalized linear mixed models were used to analyze the influence of alcohol on driving performance .


Among others , independent variables were Simulator Sickness Questionnaire scores and subjective sleepiness .


Subjects did not experience simulator sickness during the experiments .


Mean BAC before the second test drive was 0.065 % in the mildly intoxicated group .


There was no clear-cut difference in the number of crashes between 2 groups .


BAC of 0.1 % would deteriorate mean braking reaction time by 237 ms ( SE = 112 , p < 0.05 ) .


Ethanol slightly impaired the tracking in the right-hand curves ( p = 0.058 ) .


Braking reaction time improved by 86 ms ( SE = 36 , p < 0.05 ) for the second test drive , indicating a learning effect .


In sum , a clear ethanol effect was observed in the driving simulation .


This simulation seems suitable for occupational research and produces little simulator sickness .


Controlling for possible learning effects is recommended in driving simulation studies .


To determine the prognostic value of outer retinal tubulation ( ORT ) in the enlargement amount of geographic atrophy ( GA ) in eyes with age-related macular degeneration ( AMD ) .


Cohort study .


One hundred eight fellow untreated eyes of 143 patients with GA resulting from AMD enrolled in the MAHALO study ( clinicaltrials.gov identifier , NCT01229215 ) who completely satisfied the study term and had gradable spectral-domain optical coherence tomography ( OCT ) images obtained at both baseline and month 18 visits .


The MAHALO study enrolled 143 subjects into a phase 1b/2 multicenter , randomized , single-masked , sham-injection controlled clinical trial of the safety , tolerability , and evidence of activity of lampalizumab in patients with GA associated with AMD .


Spectral-domain optical coherence tomography images were obtained at multiple time points in both eyes , although only the baseline and month 18 data of the fellow ( nonstudy ) eyes were considered in this exploratory analysis .


The Cirrus HD-OCT review software was used for automatic segmentation and measurement of GA areas , with manual correction of segmentation errors by certified OCT graders .


Baseline OCT images also were assessed for the presence of ORT .


The enlargement amount of GA in eyes with ORT was compared with that of eyes without ORT .


Comparison of the enlargement amount of GA in eyes with and without ORT .


Twenty-four of these 108 eyes demonstrated evidence of ORT .


The amount of enlargement of GA in eyes with ORT was significantly slower than that of eyes without ORT ( 1.850.78 vs. 2.671.61 ; P = 0.001 ) .


This difference remained significant when considering subgroups with unifocal or multifocal GA lesions , because eyes with ORT in both subgroups had a slower enlargement amount of GA than eyes without ORT ( 2.911.70 vs. 2.080.88 [ P = 0.01 ] , in eyes with multifocal GA lesions ; and 2.241.40 vs. 1.630.57 [ P = 0.02 ] , in eyes with unifocal GA lesions ) .


In eyes with ORT , GA lesions seem to enlarge at a significantly slower rate than those of eyes without ORT .


The presence of ORT may need to be accounted for in longitudinal studies of GA. .


To compare the efficacy and safety of ranibizumab 0.5 mg , guided by visual acuity ( VA ) stabilization or disease activity criteria , versus verteporfin photodynamic therapy ( vPDT ) in patients with visual impairment due to myopic choroidal neovascularization ( CNV ) .


Phase III , 12-month , randomized , double-masked , multicenter , active-controlled study .


Patients ( N = 277 ) with visual impairment due to myopic CNV .


Patients were randomized to receive ranibizumab on day 1 , month 1 , and thereafter as needed guided by VA stabilization criteria ( group I , n = 106 ) ; ranibizumab on day 1 and thereafter as needed guided by disease activity criteria ( group II , n = 116 ) ; or vPDT on day 1 and disease activity treated with ranibizumab or vPDT at investigators ' discretion from month 3 ( group III , n = 55 ) .


Mean average best-corrected visual acuity ( BCVA ) change from baseline to month 1 through months 3 ( primary ) and 6 , mean BCVA change and safety over 12 months .


Ranibizumab treatment in groups I and II was superior to vPDT based on mean average BCVA change from baseline to month 1 through month 3 ( group I : +10.5 , group II : +10.6 vs. group III : +2.2 Early Treatment Diabetic Retinopathy Study [ ETDRS ] letters ; both P < 0.0001 ) .


Ranibizumab treatment guided by disease activity was noninferior to VA stabilization-guided retreatment based on mean average BCVA change from baseline to month 1 through month 6 ( group II : +11.7 vs. group I : +11.9 ETDRS letters ; P < 0.00001 ) .


Mean BCVA change from baseline to month 12 was +13.8 ( group I ) , +14.4 ( group II ) , and +9.3 ETDRS letters ( group III ) .


At month 12 , 63.8 % to 65.7 % of patients showed resolution of myopic CNV leakage .


Patients received a median of 4.0 ( group I ) and 2.0 ( groups II and III ) ranibizumab injections over 12 months .


No deaths or cases of endophthalmitis and myocardial infarction occurred .


Ranibizumab treatment , irrespective of retreatment criteria , provided superior BCVA gains versus vPDT up to month 3 .


Ranibizumab treatment guided by disease activity criteria was noninferior to VA stabilization criteria up to month 6 .


Over 12 months , individualized ranibizumab treatment was effective in improving and sustaining BCVA and was generally well tolerated in patients with myopic CNV .


Widespread psoriasis has great effects on life .


Effective and rapid response in the treatment is needed .


So this study was done to compare the efficacy of combined narrowband ultraviolet-B ( NBUVB ) plus methotrexate ( MTX ) versus each one alone in the treatment of psoriasis .


A total of 120 patients with widespread plaque-type psoriasis were enrolled , but only 113 patients completed the study .


They were divided into three groups randomly , group MN ( 38 ) received NBUVB plus MTX , group N ( 38 ) received NBUVB alone , and group M ( 37 ) received MTX only .


End point of treatment ( clearance ) was 90 % reduction in Psoriasis Area and Severity Index ( PASI ) Score or up to six months , whichever was earlier ; follow-up was done for one year .


The mean number of weeks required for achieving clearance was 6.11 1.28 weeks in group MN , 11.42 2.36 weeks in group N , and 20.87 4.21 weeks in group M ( P < 0.0001 ) .


The mean number of phototherapy sessions was 17.86 3.74 sessions in group MN , and 33.51 6.9 sessions in group N ( P < 0.0001 ) .


The mean total cumulative dose of NBUVB for achieving clearance was 12.13 4.02 J/cm ( 2 ) in group MN , compared with 34.48 13.13 J/cm ( 2 ) in group N ( P < 0.0001 ) , while the mean total cumulative dose of MTX was 116.04 20.47 mg in group MN compared with 298.63 60.26 mg in group M ( P < 0.0001 ) .


Combination of NBUVB plus MTX provided rapid improvement with less cumulative doses of both therapies compared with each one alone in the treatment of psoriasis .


A number of investigative strategies exist for the diagnosis of coronary heart disease ( CHD ) .


Despite the widespread availability of noninvasive imaging , invasive angiography is commonly used early in the diagnostic pathway .


Consequently , approximately 60 % of angiograms reveal no evidence of obstructive coronary disease .


Reducing unnecessary angiography has potential financial savings and avoids exposing the patient to unnecessary risk .


There are no large-scale comparative effectiveness trials of the different diagnostic strategies recommended in international guidelines and none that have evaluated the safety and efficacy of cardiovascular magnetic resonance .


CE-MARC 2 is a prospective , multicenter , 3-arm parallel group , randomized controlled trial of patients with suspected CHD ( pretest likelihood 10 % -90 % ) requiring further investigation .


A total of 1,200 patients will be randomized on a 2:2:1 basis to receive 3.0-T cardiovascular magnetic resonance-guided care , single-photon emission computed tomography-guided care ( according to American College of Cardiology/American Heart Association appropriate-use criteria ) , or National Institute for Health and Care Excellence guidelines-based management .


The primary ( efficacy ) end point is the occurrence of unnecessary angiography as defined by a normal ( > 0.8 ) invasive fractional flow reserve .


Safety of each strategy will be assessed by 3-year major adverse cardiovascular event rates .


Cost-effectiveness and health-related quality-of-life measures will be performed .


The CE-MARC 2 trial will provide comparative efficacy and safety evidence for 3 different strategies of investigating patients with suspected CHD , with the intension of reducing unnecessary invasive angiography rates .


Evaluation of these management strategies has the potential to improve patient care , health-related quality of life , and the cost-effectiveness of CHD investigation .


To determine if an abnormal CA-125 level in a menopausal female without ovarian cancer is associated with an increase in mortality .


The Prostate , Lung , Colorectal , and Ovarian Cancer Screening Randomized Controlled ( PLCO ) Trial is a large multicenter prospective trial conducted by the National Cancer Institute ( NCI ) .


Over 78,000 healthy women aged 55-74 were randomized to a screening arm versus a usual medical care arm to evaluate the efficacy of screening in reducing mortality due to ovarian cancer .


Women in the screening arm underwent annual screening for ovarian cancer with transvaginal ultrasound and CA-125 levels .


There were 38,818 patients without ovarian cancer that had at least one CA-125 level drawn ; 1201 ( 3.09 % ) had at least one abnormal level .


The current study compares mortality in patients that had one or more abnormal CA-125 levels without ovarian cancer versus those with all normal levels .


Patients with one or more abnormal CA-125 levels , without ovarian cancer , had a significantly higher mortality than patients with all normal CA-125 levels in the PLCO screening trial ( p < 0.0001 ) .


This increased risk extended throughout the follow-up period .


Analysis of cause of death listed on the death certificate showed an excess mortality attributable to lung cancer , digestive disease , and endocrine , nutritional , and metabolic disease .


Menopausal females with an elevated CA-125 and without ovarian cancer are exposed to an increased risk of premature mortality .


Cariprazine is an orally active and potent D3 and D2 partial agonist with preferential binding to D3 receptors in development for the treatment of schizophrenia and bipolar mania .


This study ( NCT00694707 ) evaluated the efficacy and safety of cariprazine in patients with acute exacerbation of schizophrenia .


This study was a multinational , double-blind , randomized , placebo - and active-controlled , fixed-dose trial .


Patients were randomized to receive placebo , cariprazine 1.5 mg/d , cariprazine 3.0 mg/d , cariprazine 4.5 mg/d , or risperidone 4.0 mg/d ( for assay sensitivity ) for 6 weeks of double-blind treatment and 2 weeks of safety follow-up .


Primary and secondary efficacy parameters were change from baseline to Week 6 in Positive and Negative Syndrome Scale ( PANSS ) total and Global Impressions-Severity of Illness ( CGI-S ) scores , respectively .


Safety parameters included adverse events ( AEs ) , vital signs , laboratory measures , and extrapyramidal symptom ( EPS ) scales .


Of 732 randomized patients , 64 % completed the study .


PANSS total score improvement at Week 6 was statistically significant versus placebo for cariprazine 1.5 mg/d , 3.0 mg/d , and 4.5 mg/d ( least squares mean difference [ LSMD ] : -7.6 , -8.8 , -10.4 , respectively ; p < 0.001 ; LOCF ) and risperidone ( -15.1 , p < 0.001 ; LOCF ) ; significant improvement on CGI-S was demonstrated for all active treatments ( p < 0.05 ) .


The most frequent cariprazine AEs ( 5 % and at least twice the rate of the placebo group ) were insomnia , extrapyramidal disorder , akathisia , sedation , nausea , dizziness , and constipation .


Mean changes in metabolic parameters were small and similar between groups .


The results of this study support the efficacy and safety of cariprazine in patients with acute exacerbation of schizophrenia .


Limited data exists regarding the relationship between left ventricular systolic dysfunction ( LVSD ) and heart failure ( HF ) symptoms and embolic risk among patients with atrial fibrillation .


Participants in the Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events ( ACTIVE ) trials with HF , but not randomized to oral anticoagulation , were categorized as having preserved versus reduced ejection fraction .


If reduced , LVSD was classified as mild , moderate , or severe .


Symptoms were quantified using New York Heart Association class.The primary outcome was a composite of stroke , transient ischemic attack , and systemic embolism .


There were 3487 antiplatelet-treated patients with HF at baseline .


Of these patients , 969 ( 46.8 % ) had HF with preserved ejection fraction and 1103 ( 53.2 % ) had HF with reduced ejection fraction .


During 3.6 years of mean follow-up , first occurrence of stroke , transient ischemic attack , or systemic embolism occurred in 386 patients.The strongest independent predictors of embolic events were age 75 years ( hazard ratio 2.55 ; confidence interval , 1.85-3 .53 ) , prior stroke or transient ischemic attack ( hazard ratio 2.07 ; 95 % confidence interval , 1.65-2 .60 ) , and female sex ( hazard ratio 1.37 ; confidence interval , 1.11-1 .69 ) .


However , ejection fraction < 0.50 , degree of LVSD , and New York Heart Association class did not predict embolic events .


Patients with HF with preserved ejection fraction exhibited similar risk of embolic events as those with HR with reduced ejection fraction : 4.3 % versus 4.4 % per 100 person-years ( hazard ration 1.01 ; 95 % confidence interval , 0.78-1 .31 ) .


Risk of embolic events was similar across categories of LVSD ( P for trend = 0.96 ) and New York Heart Association class ( P for trend = 0.57 ) .


Among HF patients in ACTIVE , neither the presence of LVSD or degree of symptom severity influenced risk of embolic events .


We previously have shown that buttonhole needling is associated with a reduction in hematoma and postulated that buttonhole needling may increase long-term survival of an arteriovenous fistula ( AVF ) .


The purpose of this study was to evaluate AVF survival and complications in buttonhole versus standard needling .


Long-term follow up of a randomized controlled trial in which participants were randomly assigned to standard or buttonhole needling and followed up until the AVF was abandoned or the study end date .


140 long-term hemodialysis patients in Calgary , Alberta .


Buttonhole needling with median time of exposure to the intervention of 13.2 ( IQR , 7.8-19 .4 ) months .


Patients were prospectively followed up for study outcomes .


Median follow-up times were 17.2 ( IQR , 11.9-37 .8 ) and 19.2 ( IQR , 12.5-41 .0 ) months for standard and buttonhole needling , respectively ( P = 0.2 ) .


The primary outcome was median access survival in months .


Other outcomes included assisted and unassisted patency rates , rates of surgical and radiologic interventions , and time to abandonment ( months ) of buttonhole .


Baseline characteristics were similar .


The primary outcome , median access survival , was similar inboth groups : 16.0 ( IQR , 10.6-29 .3 ) and 18.4 ( IQR , 10.9-32 .7 ) months for standard and buttonhole needling , respectively ( P = 0.2 ) .


There were 7 ( 10.1 % ) and 6 ( 8.6 % ) thromboses with standard and buttonhole needling , respectively ( P = 0.6 ) .


Median fistulogram rates were similar between techniques ( P = 0.2 with intention-to-treat analysis ) .


Most patients ( 46 of 70 ) abandoned buttonhole needling by a median of 11.3 ( IQR , 4.8-18 .2 ) months .


Median time to first infection for buttonhole needling was 11.1 ( IQR , 4.9-30 .0 ) months .


There were no infections in standard needling of AVFs .


Findings are limited to patients needled by multiple hemodialysis nurses and not applicable to self-needlers .


AVFs with buttonhole needling did not have improved survival .


The lack of survival benefit and higher risk of infection should be noted when promoting buttonhole needling .


The Age-Related Eye Disease Study ( AREDS ) formulation for the treatment of age-related macular degeneration ( AMD ) contains vitamin C , vitamin E , beta carotene , and zinc with copper .


The Age-Related Eye Disease Study 2 ( AREDS2 ) assessed the value of substituting lutein/zeaxanthin in the AREDS formulation because of the demonstrated risk for lung cancer from beta carotene in smokers and former smokers and because lutein and zeaxanthin are important components in the retina .


To further examine the effect of lutein/zeaxanthin supplementation on progression to late AMD .


The Age-Related Eye Disease Study 2 is a multicenter , double-masked randomized trial of 4203 participants , aged 50 to 85 years , at risk for developing late AMD ; 66 % of patients had bilateral large drusen and 34 % had large drusen and late AMD in 1 eye .


In addition to taking the original or a variation of the AREDS supplement , participants were randomly assigned in a factorial design to 1 of the following 4 groups : placebo ; lutein/zeaxanthin , 10 mg/2 mg ; omega-3 long-chain polyunsaturated fatty 3 acids , 1.0 g ; or the combination .


S Documented development of late AMD by central , masked grading of annual retinal photographs or by treatment history .


RESULTS In exploratory analysis of lutein/zeaxanthin vs no lutein/zeaxanthin , the hazard ratio of the development of late AMD was 0.90 ( 95 % CI , 0.82-0 .99 ; P = .04 ) .


Exploratory analyses of direct comparison of lutein/zeaxanthin vs beta carotene showed hazard ratios of 0.82 ( 95 % CI , 0.69-0 .96 ; P = .02 ) for development of late AMD , 0.78 ( 95 % CI , 0.64-0 .94 ; P = .01 ) for development of neovascular AMD , and 0.94 ( 95 % CI , 0.70-1 .26 ; P = .67 ) for development of central geographic atrophy .


In analyses restricted to eyes with bilateral large drusen at baseline , the direct comparison of lutein/zeaxanthin vs beta carotene showed hazard ratios of 0.76 ( 95 % CI , 0.61-0 .96 ; P = .02 ) for progression to late AMD , 0.65 ( 95 % CI , 0.49-0 .85 ; P = .002 ) for neovascular AMD , and 0.98 ( 95 % CI , 0.69-1 .39 ; P = .91 ) for central geographic atrophy .


The totality of evidence on beneficial and adverse effects from AREDS2 and other studies suggests that lutein/zeaxanthin could be more appropriate than beta carotene in the AREDS-type supplements .


clinicaltrials.gov Identifier : NCT00345176 .


QVA149 is a dual bronchodilator , containing a fixed-dose combination of the long-acting 2-agonist indacaterol and long-acting muscarinic antagonist glycopyrronium , for the treatment of chronic obstructive pulmonary disease ( COPD ) .


Here we assess the potential of QVA149 ( 440/200 g ) at 4-fold the therapeutic dose for causing cardiac pharmacodynamic ( PD ) effects .


This double-blind , randomized study estimated the time-matched largest heart rate ( HR ) change and average HR change ( over 24 hours ) from baseline for QVA149 vs. placebo in healthy subjects .


Similar analyses were done for QVA149 vs. indacaterol 600 g , glycopyrronium 200 g , and salmeterol 200 g.


The time-matched and average change from baseline in QT interval corrected for HR using Fridericia 's formula ( QTcF ) , effects on serum potassium and blood glucose , pharmacokinetic ( PK ) parameters , and safety were also assessed .


Of 50 subjects randomized , 43 completed the study .


QVA149 , when compared with placebo , showed the time-matched largest mean increase and decrease in HR of 5.69 bpm and -2.51 bpm , respectively , and average HR change from baseline of 0.62 bpm .


QVA149 showed no tachycardic potential compared with indacaterol and no relevant tachycardic effect compared with glycopyrronium .


No consistent differences were seen in the time-matched largest mean change and average change from baseline in QTcF for QVA149 vs. other treatments .


There were no relevant effects of QVA149 on serum potassium and blood glucose .


There was no apparent PK/PD relationship between the observed exposures to indacaterol and glycopyrronium in QVA149 on HR and QTcF .


There were no deaths or serious adverse events .


Overall , short-term administration of QVA149 showed a good cardiovascular safety and tolerability profile in healthy subjects .


To observe the effects of navel-warming therapy on clinical efficacy in patients with yang-deficiency tympanites based on regular treatment of western medication .


One hundred and twenty cases of yang-deficiency tympanites were randomly divided into a navel-warming therapy group and a western medication group , sixty cases in each one .


The regular treatment of western medicine was applied in the western medication group , including oral administration of antiviral drug and diuretics as well as intravenous drip of hepatic protector .


Based on western medicine treatment , the navel-warming therapy was applied in the navel-warming group .


A medical cake was laid on Shenque ( CV 8 ) , and then a medical cylinder was placed above the medical cake and ignited .


The treatment was given once daily .


One month was considered as a treatment session in both groups and totally one session was required .


The TCM symptom score , B-ultrasound ascites and temporary use of diuretics before and after treatment were observed in both groups ; also the efficacy was evaluated .


The total effective rate was 81.7 % ( 49/60 ) in the navel-warming therapy group , which was superior to 56.7 % ( 34/60 ) in the western medication group ( P < 0.05 ) .


After the treatment , the TCM symptom score and ascites were improved in both groups ( all P < 0.05 ) , which was more significant in the navel-warming therapy group ( all P < 0.05 ) .


The temporary use of diuretics was statistically different between the two groups ( P < 0.05 ) , indicating the navel-warming therapy group could obviously reduce or stop the use of diuretics .


Based on regular treatment of western medication , the navel-warming therapy could significantly improve therapeutic efficacy , effectively relieve clinical symptoms and ease ascites .


The purpose of this study was to identify gene polymorphisms of interleukin-18 ( IL-18 ) -607 A/C and -137 G/C specific to patients with oral cancer susceptibility and clinicopathological status .


A total of 1,126 participants , including 559 healthy people and 567 patients with oral cancer , were recruited for this study .


Allelic discrimination of -607 A/C ( rs1946518 ) and -137 G/C ( rs187238 ) polymorphisms of the IL-18 gene was assessed by a real-time PCR with the TaqMan assay .


There was no significant association between IL-18 -607 A/C polymorphism and oral cancer risk .


However , among alcohol consumers , people with A/A homozygotes of IL-18 -607 A/C polymorphism had a 2.38-fold ( 95 % CI = 1.17-4 .86 ; p = 0.01 ) increased risk of developing oral cancer compared with those with C/C homozygotes .


The participants with G/C heterozygotes of IL-18 -137 polymorphism had a 1.64-fold ( 95 % CI : 1.08-2 .48 ; p = 0.02 ) increased risk of developing oral cancer compared with those with G/G wild type homozygotes .


Both sets of statistics were determined after adjusting for confounding factors .


Among people who had exposure to oral cancer-related environmental risk factors such as areca , alcohol , and tobacco consumption , the adjusted odd ratios and 95 % confidence intervals were increased to a 2.02-fold ( 95 % CI = 1.01-4 .04 ; p = 0.04 ) , 4.04 ( 95 % CI = 1.65-9 .87 ; p = 0.002 ) and a 1.66-fold ( 95 % CI = 1.00-2 .84 ; p = 0.05 ) risk of developing oral cancer .


However , patients with G/C alleles of IL-18 -137 were correlated with a lower clinical stage ( AOR = 0.59 ; 95 % CI = 0.39-0 .89 ; p = 0.01 ) , smaller tumor size ( AOR = 0.56 ; 95 % CI = 0.35-0 .87 ; p = 0.01 ) , and non-lymph node metastasis ( AOR = 0.51 ; 95 % CI = 0.32-0 .80 ; p = 0.003 ) .


IL-18 -137 G/C gene polymorphism may be a factor that increases the susceptibility to oral cancer , as well as a protective factor for oral cancer progression .


The interactions of gene to oral cancer-related environmental risk factors have a synergetic effect that can further enhance oral cancer development .


Exact mechanism of causation of chronic kidney disease of unknown etiology ( CKDu ) in Sri Lanka is not described to date , despite the identification of possible multiple risk factors .


Questions have been raised as to why only some are affected while others remain intact , though they are inhabitants of the same locality .


Comparative studies were carried out , assessing urinary 2 microglobulin ( 2m ) and the dietary patterns of CKDu patients and age sex matched non-CKDu subjects .


Urinary 2m levels of spot urine samples were analyzed using the Enzyme-linked Immunosorbent assay ( ELISA ) and dietary patterns were studied using twenty four hour dietary recalls and frequency consumption of foods of animal origin performed on three occasions at six months intervals within a period of one and half years .


The mean urinary 2m level of CKDu patients from Medawachchiya was significantly ( p < 0.05 ) higher when compared with that of the non-CKDu subjects .


The mean urinary 2m level of the non-CKDu subjects was within the reference limits for spot urine samples ( 0 - 0.3 g/mL ) .


White raw rice was the staple diet of both CKDu patients and non-CKDu subjects and the level of consumption was almost the same .


The consumption of fresh water fish products of CKDu patients under high ( 14 , 14 % ) , moderate ( 36 , 36 % ) , low ( 26 , 26 % ) and less ( 20 , 20 % ) categories did not show significant variations ( p > 0.05 ) compared to non-CKDu subjects .


Staple food in diet and the consumption pattern of CKDu patients from Medawachchiya were similar to that of non-CKDu subjects from the same area despite their urinary 2m concentration being significantly higher .


To assess efficacy of membrane peeling combined with intravitreal injection of bevacizumab in the treatment of macular epiretinal membrane .


From January , 2012 to June , 2013 , 33 patients ( 33 eyes ) with the diagnosis of macular epiretinal membrane underwent vitreous surgery and membrane peeling .


The patients were randomly divided into intravitreal bevacizumab group ( IVB group ) and non-intravitreal bevacizumab group ( non-IVB group ) .


All the patients underwent standard three-port vitrectomy and peeling of epiretinal membrane , with intravitreal injection of 1.5 mg bevacizumab at the end of operation in IVB group .


The best corrected visual acuity and optical coherence tomography ( OCT ) were examined before and after the treatment .


The patients were followed up for 3-14 months ( mean 6.5 months ) .


Macular epiretinal membranes were successfully peeled during operation in all the patients without postoperative intraocular infection or bleeding .


Fifteen eyes received vitrectomy combined with intravitreal injection of bevacizumab , and 18 underwent only vitreous operation and membrane peeling .


At the end of the follow up , the visual acuity improved in 11 eyes ( 73.3 % ) in IVB group , as compared to 13 eyes ( 72.2 % ) in the non-IVB group ( P = 0.627 ) .


Central macular thickness decreased by 14362 m in IVB group and by 9628 m in non-IVB group , showing a significant difference between the two groups ( t = 5.564 , P < 0.01 ) .


Vitrectomy and membrane peeling combined with intravitreal injection of bevacizumab can promote the recovery of macular morphology but not visual function , and its clinical use still needs to be tested in a long-term and large-sample randomized controlled study .


Alcohol consumption is common on college campuses and is associated with negative consequences .


Factors associated with availability of alcohol are not completely understood .


To describe how proximity and density of alcohol outlets are associated with any drinking and binge drinking in students at the University of Wisconsin-Madison .


Participants were full-time students enrolled in the Young Adults Eating and Active for Health , a multisite , randomized intervention that assessed a variety of health behaviors .


Geographic information systems were used to calculate proximity and enumerate alcohol outlet densities .


Participants were categorized as `` drinkers '' or `` nondrinkers '' based on self-reported alcohol consumption .


Binge drinking was categorized as `` non-binge drinker , '' `` frequent binge drinker , '' and `` excessive binge drinker . ''


Analysis included regression , t tests , and chi-square tests .


RESULTS .


Among the 166 participants , 126 ( 76 % ) were drinkers .


Among drinkers , 80 ( 63 % ) were either frequent or excessive binge drinkers .


Drinkers lived closer to an alcohol outlet than non-drinkers ( 0.18 + / - 0.15 vs. 0.61 + / - 1.59 miles , respectively , P = 0.005 ) .


Within a 1-mile walking radius , there were 47 % more establishments for drinkers ( 153 + / - 47 compared to 104 + / - 55 outlets for nondrinkers , P < 0.0001 ) .


At distances of 0.10-0 .25 and 0.25-0 .50 miles , twice as many outlets were available to drinkers ( 19 + / - 19 and 43 + / - 25 , respectively ) compared to nondrinkers ( 7 + / - 11 and 20 + / - 22 , respectively ) , P < 0.001 .


Proximity and density were hot associated with binge drinking frequency .


Drinkers lived closer to alcohol outlets and had significantly more outlets available at a distance of up to 1 mile .


Municipal and college administrators could consider limiting alcohol license distributions in municipalities with high alcohol consumption .


Hyperkalemia is a potentially life-threatening condition predominantly seen in patients treated with renin-angiotensin-aldosterone system ( RAAS ) inhibitors with stage 3 or greater chronic kidney disease ( CKD ) who may also have diabetes , heart failure , or both .


To select starting doses for a phase 3 study and to evaluate the long-term safety and efficacy of a potassium-binding polymer , patiromer , in outpatients with hyperkalemia .


Phase 2 , multicenter , open-label , dose-ranging , randomized clinical trial ( AMETHYST-DN ) , conducted at 48 sites in Europe from June 2011 to June 2013 evaluating patiromer in 306 outpatients with type 2 diabetes ( estimated glomerular filtration rate , 15 to < 60 mL/min/1 .73 m2 and serum potassium level > 5.0 mEq/L ) .


All patients received RAAS inhibitors prior to and during study treatment .


Patients were stratified by baseline serum potassium level into mild or moderate hyperkalemia groups and received 1 of 3 randomized starting doses of patiromer ( 4.2 g [ n = 74 ] , 8.4 g [ n = 74 ] , or 12.6 g [ n = 74 ] twice daily [ mild hyperkalemia ] or 8.4 g [ n = 26 ] , 12.6 g [ n = 28 ] , or 16.8 g [ n = 30 ] twice daily [ moderate hyperkalemia ] ) .


Patiromer was titrated to achieve and maintain serum potassium level 5.0 mEq/L or lower .


The primary efficacy end point was mean change in serum potassium level from baseline to week 4 or prior to initiation of dose titration .


The primary safety end point was adverse events through 52 weeks .


Secondary efficacy end points included mean change in serum potassium level through 52 weeks .


A total of 306 patients were randomized .


The least squares mean reduction from baseline in serum potassium level at week 4 or time of first dose titration in patients with mild hyperkalemia was 0.35 ( 95 % CI , 0.22-0 .48 ) mEq/L for the 4.2 g twice daily starting-dose group , 0.51 ( 95 % CI , 0.38-0 .64 ) mEq/L for the 8.4 g twice daily starting-dose group , and 0.55 ( 95 % CI , 0.42-0 .68 ) mEq/L for the 12.6 g twice daily starting-dose group .


In those with moderate hyperkalemia , the reduction was 0.87 ( 95 % CI , 0.60-1 .14 ) mEq/L for the 8.4 g twice daily starting-dose group , 0.97 ( 95 % CI , 0.70-1 .23 ) mEq/L for the 12.6 g twice daily starting-dose group , and 0.92 ( 95 % CI , 0.67-1 .17 ) mEq/L for the 16.8 g twice daily starting-dose group ( P < .001 for all changes vs baseline by hyperkalemia starting-dose groups within strata ) .


From week 4 through week 52 , statistically significant mean decreases in serum potassium levels were observed at each monthly point in patients with mild and moderate hyperkalemia .


Over the 52 weeks , hypomagnesemia ( 7.2 % ) was the most common treatment-related adverse event , mild to moderate constipation ( 6.3 % ) was the most common gastrointestinal adverse event , and hypokalemia ( < 3.5 mEq/L ) occurred in 5.6 % of patients .


Among patients with hyperkalemia and diabetic kidney disease , patiromer starting doses of 4.2 to 16.8 g twice daily resulted in statistically significant decreases in serum potassium level after 4 weeks of treatment , lasting through 52 weeks .


clinicaltrials.gov Identifier : NCT01371747 .


Preterm infants are at risk for adverse neurodevelopment .


Furthermore , nutrition may play a key role in supporting neurodevelopment .


The aim of this study was to evaluate whether a nutrient-enriched formula fed to preterm infants after hospital discharge could improve their neurodevelopment at 24 months ( term-corrected age ) .


We conducted an observer-blinded , single-center , randomized controlled trial in infants admitted to the Fondazione IRCCS C Granda Ospedale Maggiore Policlinico , University of Milan , Italy between 2009 and 2011 .


Inclusion criteria were gestational age < 32 weeks and/or birth weight < 1500 g , and being fed human milk for < 20 % of the total milk intake .


Exclusion criteria were congenital malformations or conditions that could interfere with growth or body composition .


Included infants were randomized to receive a standard full-term formula or a nutrient-enriched formula up until 6 months of corrected age , using two computer-generated randomization lists ; one appropriate for gestational age ( AGA ) and one for small for gestational age ( SGA ) infants .


We assessed neurodevelopment at 24 months of corrected age using the Griffiths Mental Development Scale and related subscales ( locomotor , personal-social , hearing and speech , hand and eye coordination , and performance ) .


Of the 207 randomized infants , 181 completed the study .


52 AGA and 35 SGA infants were fed a nutrient-enriched formula , whereas 56 AGA and 38 SGA infants were fed a standard full-term formula .


The general quotient at 24 months of corrected age was not significantly different between infants randomized to receive a nutrient-enriched formula compared with a standard term formula up until 6 months of corrected age ( AGA infants : 93.8 12.6 vs. 92.4 10.4 , respectively ; SGA infants : 96.1 9.9 vs. 98.2 9 , respectively ) .


The scores of related subscales were also similar among groups .


This study found that feeding preterm infants a nutrient-enriched formula after discharge does not affect neurodevelopment at 24 months of corrected age , in either AGA or SGA infants , free from major comorbidities .


Current Controlled Trials ( http://www.controlled-trials.com/ISRCTN30189842 ) London , UK .


The primary purpose of this randomized controlled trial ( RCT ) was to evaluate the efficacy of internet-based problem-solving training ( iPST ) for employees in the educational sector ( teachers ) with depressive symptoms .


The results of training were compared to those of a waitlist control group ( WLC ) .


One-hundred and fifty teachers with elevated depressive symptoms ( Center for Epidemiologic Studies Depression Scale , CES-D 16 ) were assigned to either the iPST or WLC group .


The iPST consisted of five lessons , including problem-solving and rumination techniques .


Symptoms were assessed before the intervention began and in follow-up assessments after seven weeks , three months , and six months .


The primary outcome was depressive symptom severity ( CES-D ) .


Secondary outcomes included general and work-specific self-efficacy , perceived stress , pathological worries , burnout symptoms , general physical and mental health , and absenteeism .


iPST participants displayed a significantly greater reduction in depressive symptoms after the intervention ( d = 0.59 , 95 % CI 0.26-0 .92 ) , after three months ( d = 0.37 , 95 % CI 0.05-0 .70 ) and after six months ( d = 0.38 , 95 % CI 0.05-0 .70 ) compared to the control group .


The iPST participants also displayed significantly higher improvements in secondary outcomes .


However , workplace absenteeism was not significantly affected .


iPST is effective in reducing symptoms of depression among teachers .


Disseminated on a large scale , iPST could contribute to reducing the burden of stress-related mental health problems among teachers .


Future studies should evaluate iPST approaches for use in other working populations .


Anaemia is a major cardiovascular risk factor in chronic kidney disease ( CKD ) .


Treatment and correction of anaemia leads to improvement of cardiovascular status and quality of life of patients with CKD .


This interventional open labeled randomised controlled study comparing the effect of intravenous and oral iron therapy in improving red cell indices and iron status in anaemic pre-dialysis Chronic Kidney Disease was carried out to determine iron status in anaemic pre-dialysis CKD patients to assess the benefit of parenteral iron supplementation as against empirical oral iron in CKD patients with iron deficiency .


Sixty consecutive pre-dialysis chronic kidney disease patients attending the renal clinic over a six month period were screened .


Forty - one subjects ( 68.3 % ) were found to be anaemic and were subsequently studied .


The ages of the patients ranged between 19 and 71 years with a mean age of 39 years .


The mean serum creatinine and mean creatinine clearance were 201.80 ( 70.25 ) ?


mol/L and 37.90 ( 12.17 ) ml/minute respectively .


The haematocrit concentration was found to correlate inversely with the level of serum creatinine and 56.1 % of the anaemic patients had iron deficiency .


The mean PCV rise in the intravenous iron group was 2.42 ( 1.98 ) % and this was statistically significant ( p = 0.002 ) while the mean PCV difference was 0.909 ( 0.94 ) % in the oral iron group .


Intravenously administered iron alone permitted anaemia correction in about one-third of these patients without any life threatening adverse drug event .


Anaemia is very common in the pre-dialysis CKD population and the prevalence of iron deficiency is high .


Intravenous iron supplementation is an effective and safe treatment for the anaemia in the pre-dialysis CKD patients .


Response to oral iron was poor .


Conventional endotracheal intubation requires laryngoscopy for a direct view of the glottis .


However , laryngoscopy is associated with many potential complications .


The aim of the present study was to compare the efficacy and safety of pyriform sinus localization-assisted blind orotracheal intubation with those of conventional laryngoscopic orotracheal intubation .


A randomized , patient-blind , prospective study of 300 patients who underwent various operations was performed .


One hundred patients were assigned to the laryngoscopic intubation group ( laryngoscopy group ) , and 200 patients were assigned to the blind intubation group ( blind group ) .


The total intubation success rate in the blind group was similar to that in the laryngoscopy group ( 100 % vs. 99 % , respectively ; p = 0.33 ) .


Oxygen saturation by pulse oximetry in both groups was maintained at > 98 % .


The intubation time was significantly shorter in the blind group than in the laryngoscopy group ( 9.73.4 s vs. 23.05.8 s , respectively ; p < 0.001 ) .


Postoperative complication rates were significantly lower in the blind group than in the laryngoscopy group .


Recovery time from these symptoms was significantly shorter in the blind group than in the laryngoscopy group ( p = 0.004 ) .


Pyriform sinus localization-assisted blind orotracheal intubation was shown to be more effective than conventional laryngoscopic orotracheal intubation in terms of success rate , intubation time , and postoperative complication rate .


Moreover , it is less affected by common risk factors ; thus , this method may be more beneficial in patients with difficult airways .


Most published contraceptive continuation rates have scientific limitations and can not be compared ; this is particularly true for dissimilar contraceptives .


This study uses a new approach to determine if high continuation rates of long-acting reversible contraception ( LARC ) and protection from unintended pregnancy are observable in a population not self-selecting to use LARC .


We are conducting a partially randomized patient preference trial ( PRPPT ) to compare continuation rates of short-acting reversible contraception ( SARC ) and LARC .


Only women seeking SARC were invited to participate .


Participants chose to be in the preference cohort ( self-selected method use ) or opted to be randomized to SARC or LARC ; only those in the randomized cohort received free product .


We compared participant characteristics , reasons for not trying LARC previously and the contraceptive choices that were made .


We enrolled 917 eligible women ; 57 % chose to be in the preference cohort and 43 % opted for the randomized trial .


The preference and randomized cohorts were similar on most factors .


However , the randomized cohort was more likely than the preference cohort to be uninsured ( 48 % versus 36 % , respectively ) and to cite cost as a reason for not trying LARC previously ( 50 % versus 10 % ) ( p < .01 for both comparisons ) .


In the preference cohort , fear of pain/injury/side effects/health risks were the predominant reasons ( cited by over 25 % ) for not trying LARC previously ( p < .01 in comparison to randomized cohort ) .


Enrollment was successful and the process created different cohorts to compare contraceptive continuation rates and unintended pregnancy in this ongoing trial .


The choices participants made were associated with numerous factors ; lack of insurance was associated with participation in the randomized trial .


This PRPPT will provide new estimates of contraceptive continuation rates , such that any benefits of LARC will be more easily attributable to the technology and not the user .


Combined with measuring level of satisfaction with LARC , the results will help project the potential role and benefits of expanding voluntary use of LARC .


To explore the effect of pectin , a kind of soluble dietary fiber , on colonic transit time ( CTT ) , clinical symptoms and gut microbiota in adults with slow-transit constipation .


A total of 80 patients with slow-transit constipation were selected between June 2011 and December 2013 .


For this randomized controlled trial , we evaluated the efficacy of pectin on intestinal transit time and other indices of constipation in adults with slow-transit constipation .


They were randomized to receive either pectin or placebo .


Treatment consisted of 4-week supplementation with 24 g/d pectin ( fiber group ) or maltodextrin ( placebo group ) .


Before and after 4-week treatment , CTT , constipation symptoms and fecal bacterial population were compared between groups .


CTT of the fiber group after treatment was lower than those of fiber group before treatment and those in the placebo group ( ( 60.2 11.2 ) h vs ( 80.3 9.5 ) , ( 79.4 11.7 ) h , P < 0.01 ) .


Constipation score of the fiber group after treatment also decreased than those of fiber group before treatment and those in the placebo group ( both P < 0.05 ) .


Bifidobacterium sp .


and Lactobacillus sp .


evidently increased ( lg copies/g :8.26 0.83 vs 6.42 1.07 and 6.48 0.82 , 6.83 0.77 vs 5.85 0.64 and 5.91 0.73 ; all P < 0.05 ) and total Clostridium sp .


significantly decreased ( 9.07 0.63 vs 9.74 0.81 and 9.66 0.43 , P < 0.05 ) in the fiber group after treatment versus the placebo group .


No significant adverse effects were reported .


Four-week soluble dietary fiber use accelerates colon transit time and alleviates clinical symptoms in patients with slow-transit constipation .


Additionally , supplementary fiber offers protective effects on gut microbiota by increasing the population of healthy microflora .


Recurrence rates of between 5 % and 25 % have been reported following surgery for chronic subdural hematoma ( CSH ) .


A previous study showed that the treatment with angiotensin converting enzyme ( ACE ) inhibitors decreases the risk of recurrence .


To test the effects of ACE inhibitors on the recurrence CSH and CSH remnant six weeks after surgery , we conducted a prospective double-blinded randomized controlled clinical trial on patients with CSHs from July 2009 until October 2012 .


Patients eligible for burr hole surgery for CSH were randomized into either an ACE inhibitor perindopril 5mg or placebo treatment daily for three months prior to surgery .


Cerebral CT scans were performed after six weeks , and clinical follow-ups were performed three months after surgery .


Additionally , a retrospective analysis of the data and CT scans from all nonrandomized patients from the same time period was performed .


Forty-seven patients were included in the randomized study .


The patients ' preoperative Glasgow Coma Scale scores were 15 .


None of the patients in the randomized group developed a recurrence after surgery .


Measurements of the sizes of the CSH before and six weeks after surgery revealed no difference between the placebo and perindopril-treated groups .


In the retrospective group ( 245 patients ) , there was no correlation between the risk of recurrence and ACE inhibitor treatment .


Our data suggest that perindopril does not diminish the size of residual CSHs six weeks after burr hole surgery and that ACE inhibitors do not decrease the risk of CSH recurrence .


Knee osteoarthritis ( OA ) progression has been linked to increased peak external knee adduction moments ( KAMs ) .


Although some trials have attempted to reduce pain and improve function in OA by reducing KAMs with a wedged footwear insole intervention , KAM reduction has not been specifically controlled for in trial designs , potentially explaining the mixed results seen in the literature .


Therefore , the primary purpose of this trial is to identify the effects of reduced KAMs on knee OA pain and function .


Forty-six patients with radiographically confirmed diagnosis medial knee OA will be recruited for this 3 month randomized controlled trial .


Recruitment will be from Alberta and surrounding areas .


Eligibility criteria include being between the ages of 40 and 85 years , have knee OA primarily localized to the medial tibiofemoral compartment , based on the American College of Rheumatology diagnostic criteria and be classified as having a Kellgren-Lawrence grade of 1 to 3 .


Patients will visit the laboratory at baseline for testing that includes dual x-ray absorptiometry , biomechanical testing , and surveys ( KOOS , PASE activity scale , UCLA activity scale , comfort visual analog scale ) .


At baseline , patients will be randomized to either a wedged insole group to reduce KAMs , or a waitlist control group where no intervention is provided .


The survey tests will be repeated at 3 months , and response to wedged insoles over 3 months will be evaluated .


This study represents the first step in systematically evaluating the effects of reduced KAMs on knee OA management by using a patient-specific wedged insole prescription procedure rather than providing the same insole to all patients .


The results of this trial will provide indications as to whether reduced KAMs are an effective strategy for knee OA management , and whether a personalized approach to footwear insole prescription is warranted .


NCT02067208 .


To compare the effects on anesthesia recovery between assisted-electroacupuncture fast tracking anesthesia and simple fast tracking anesthesia in patients with minim ally invasive percutaneous nephrolithotomy ( mPCNL ) .


Eighty cases of mPCNL were selected and randomly divided into a treatment group and a control group .


Fentanyl ( 1-2 microg/kg ) , sevoflurane ( 8 % ) and rocuronium ( 0.5 mg/kg ) were applied to perform anesthesia induction in both groups , and endotracheal inhalation of sevoflurane and intravenous pump injection of remifentanil were adopted to main anesthesia status during the operation .


20 min before anesthesia induction , bilateral Neiguan ( PC 6 ) , Neimadian , Hegu ( LI 4 ) , Yangxi ( LI 5 ) , Zhongji ( CV 3 ) , Qichong ( ST 30 ) , Zuwuli ( LR 10 ) were selected and punctured in the treatment group , and elecctroacupuncture was given after arrival of qi until 30 min after the wake-up from anesthesia and withdrawal of endotracheal tube .


The dosage for anesthesia maintenance , recovery time of awareness , extubation time , incidences of nausea , vomiting and chill and irritation of urethral catheters were observed and recorded .


( 1 ) The dosages of remifentanil and sevoflurane in the treatment group during the operation were obviously less than those in the control group [ remifentanil : ( 5.27 + / -1.23 ) micro g/kg h vs ( 7.35 + / -1.70 ) micro g/kg .


h ; sevoflurane : ( 1.12 + / -0.43 ) vol % vs ( 2.35 + / -0.87 ) vol % , both P < 0.001 ] .


( 2 ) The recovery time of awareness and extubation time in the treatment group were significantly earlier than those in the control group [ recovery time of awareness : ( 5.65 + / - 2.34 ) min vs ( 8.87 + / - 6.84 ) min , P < 0.01 ; extubation time : ( 7.23 + / -4.35 ) min vs ( 10.62 + / -8.16 ) min , P < 0.05 ] .


( 3 ) The incidences of nausea , vomiting and chill in the treatment group were significantly less than those in the control group ( all P < 0.05 ) .


( 4 ) The irritation of urethral catheters on urethra in the treatment group was significantly less than that in the control group ( P < 0.001 ) .


The assisted-electroacupuncture anesthesia could reduce the dosage of remifentanil and sevoflurane in mPCNL fast tracking anesthesia in urinary surgery , reduce the incidences of nausea , vomiting , chill and irritation of urethral catheters during recovery stage , and prompt recovery of mPCNL patients .


Photocoagulation reduces the incidence of visual loss in diabetic patients with focal macular edema , but it can induce it for Efficacy of topical ketorolac for improving visual function after photocoagulation in diabetic patients with focal macular edema 6 weeks after treatment and produces visual improvement in some cases .


Topical ketorolac may reduce the inflammation caused by photocoagulation and improve visual outcome .


To determine the efficacy of topical ketorolac for improving visual function after photocoagulation in diabetic patients with focal macular edema .


An experimental , comparative , prospective , longitudinal study in diabetic patients with focal macular edema was conducted .


Eyes were randomized into two groups of topical treatment for 3 weeks after photocoagulation ( A : ketorolac , B : placebo ) .


Best corrected visual acuity before and after treatment was compared in each group ( paired t test ) , and the proportion of eyes with visual improvement was compared between groups ( ( 2 ) ) .


The evaluation was repeated after stratifying for initial visual acuity ( 0.5 , < 0.5 ) .


There were 105 eyes included .


In group A ( n = 46 ) mean visual acuity changed from 0.50 to 0.58 ( p = 0.003 ) , and from 0.55 to 0.55 in group B ( n = 59 , p = 0.83 ) ; mean percent change was 22.3 % in group A and 3.5 % in group B ( p = 0.03 ) .


Visual improvement was identified in 25 eyes from group A ( 54.3 % ) and 19 from group B ( 32.2 % , p = 0.019 , RR 1.65 ) ; the difference only persisted when initial visual acuity was 0.5 ( 10 [ 40 % ] , group A , 5 [ 14.7 % ] , group B , p = 0.02 , RR 2.72 ) .


Topical ketorolac was more effective than placebo to improve best corrected visual acuity in diabetic patients with focal macular edema .


To describe the effectiveness of buccal misoprostol as an adjunct to laminaria for cervical ripening before later second-trimester abortion by dilation and evacuation ( D&E ) .


A randomized , double-blinded , placebo-controlled trial of 196 women undergoing D&E between 21 and 23 weeks of gestation .


Subjects had overnight laminaria and 400 mcg buccal misoprostol or placebo 3-4 h before the abortion .


We used logarithmic transformation of the primary outcome -- D&E procedure duration -- to achieve a normal distribution .


Mean D&E duration was 1.7 min shorter with misoprostol ( p = .02 ) .


The median duration was 9.7 versus 10.4 min in the misoprostol and placebo groups , respectively ( p = .09 ) .


Cervical dilation was slightly greater with misoprostol ( median 75 mm vs. 73 mm , p = .04 ) ; however , physicians did not find the misoprostol D&E s easier to complete .


Half of subjects reported severe pain after misoprostol vs. 11 % with placebo ( p < .001 ) .


Adjuvant buccal misoprostol results in slightly shorter D&E s at the cost of more side effects .


Generalised recalcitrant facial verruca plana responds poorly to current therapeutic options , including cryotherapy , topical drugs and carbon dioxide ( CO2 ) laser .


Case reports and uncontrolled studies suggested that topical photodynamic therapy ( PDT ) is effective choice of treatment free from potential complications associated with invasive therapies .


To investigate the efficacy and safety of PDT with different concentrations of photosensitiser in the treatment of verruca plana .


The two sides of a subject 's face were separately randomized to receive aminolevulinic acid ( ALA ) of 5 % , 10 % or 20 % concentration .


All patients were irradiated with 633-nm red light for 339 J/cm ( 2 ) total dose .


Complete response ( CR ) rate was assessed on Week 4 , 8 , and 16 respectively .


The mean overall clearance rate was 74.1 % , 68.8 % , and 64.6 % on Week 4 , 8 , and 12 , respectively , in the 110 treated sides .


The CR rate was lower in the 5 % - ALA group than in the 10 % - ALA group ( 14.3 % vs. 33.3 % , p < 0.05 ) and 20 % - ALA group ( 14.3 % vs. 26.3 % , p < 0.05 ) after 12 weeks .


The mean severity of pain measured by visual analogue scale ( VAS ) scoring was 3.8 ( range : 2 to 10 , depending on the lesion location ) .


The overall recurrence rate was 16.7 % ( 4/24 ) on Week 12 .


Hyperpigmentation was observed in 61 % ( 67/110 ) of all treated sides .


On Week 4 , 8 , and 16 , hyperpigmentation was more developed in the 20 % - ALA group than in the other two groups ( p < 0.05 ) .


In terms of complete clearance rate , the 5 % ALA-PDT group was significantly inferior to the 10 % and 20 % ALA-PDT groups at each follow-up .


In contrast , the 20 % ALA group showed a higher incidence rate of transient hyperpigmentation than the other two groups .


This randomised clinical trial suggests that PDT with ALA of 10 % concentration offers better efficacy and safety than 5 % or 20 % concentration for generalised recalcitrant facial verruca plana .


Vaccination is crucial to the control of equine influenza ( EI ) .


The study was conducted in an effort to lay the groundwork for achieving international harmonisation of regulatory requirements based on scientific evidence of performance of different vaccination regimes .


To evaluate the effectiveness of 3 different primary vaccination regimes : vaccination with the minimal intervals permitted by the racing authorities ; vaccination in accordance with the manufacturer 's instructions and vaccination with the longest intervals permitted by the racing authorities .


Randomised , prospective clinical trial .


The 55 seronegative unvaccinated horses in this study were subdivided by age and randomly allocated one of the 3 vaccination regimes .


All groups were sampled each time a group was vaccinated and 3-5 weeks post vaccination .


Horses were vaccinated with a subunit immune stimulating complex-based vaccine ( Equip FT ) .


Antibodies against EI were measured by single radial haemolysis .


Lengthening the vaccination intervals increased the immunity gaps between first ( V1 ) and second ( V2 ) doses , and V2 and third dose ( V3 ) but did not inhibit the response to V2 and V3 .


The response to V2 and V3 was similar irrespective of the regime .


Poor responders to V1 were identified in all age groups included in this study but the greatest number of poor responders was among the yearlings .


The 2 - and 3-year-old horses responded better to vaccination than the weanlings or yearlings .


Longer vaccination intervals permitted by racing authorities increase the periods of susceptibility to EI but they may facilitate strategic vaccination prior to times of increased risk of exposure to virus .


The study provides the type of evidence-based data necessary to commence meaningful discussion of international harmonisation of EI vaccination requirements .


The manipulation of the composition of foods consumed as between-meal snacks may aid daily energy restriction .


We compared the effects of the consumption of 2 energy-matched snack bars on appetite , energy intake ( EI ) , and metabolic and endocrine responses .


In addition , we investigated whether the acute effects of the consumption of snacks were maintained under free-living conditions and whether the habitual daily consumption of the snack over 14 d influenced these effects .


Ten lean men [ mean SD age : 30.7 9.7 y ; body mass index ( in kg/m ( 2 ) ) : 23.2 2.8 ] consumed a whey protein and polydextrose ( PPX ) snack bar or an isoenergetic control snack bar as a midmorning , between-meal snack for 14 consecutive days in a double-blind , randomized , crossover design .


The two 14-d intervention phases were separated by a 14-d washout period .


On the first ( day 1 ) and last ( day 15 ) days of each intervention phase , appetite , food intake , and blood metabolite and endocrine responses were assessed under laboratory conditions .


Free-living EI was recorded on days 4 , 8 , and 12 of interventions .


Total daily EI was significantly lower when the PPX snack was consumed during experimental days ( 10,149 831 compared with 11,931 896 kJ ; P < 0.01 ) , and daily EI remained lower when the PPX snack was consumed during the free-living part of the intervention ( 7904 610 compared with 9041 928 kJ ; P < 0.05 ) .


The PPX snack was associated with lower glucose and ghrelin and higher glucagon-like peptide 1 and peptide tyrosine-tyrosine responses .


The manipulation of the composition of foods consumed as snacks is an effective way to limit subsequent EI .


This trial was registered at clinicaltrials.gov as NCT01927926 .


To validate the device and investigate the effect of this device on symptoms , quality of life , and pelvic floor muscle strength .


The device was designed to measure vaginal pressure changes using air-pressure balloon and abdominal wall muscle activities using surface electromyography .


To test the accuracy of the device , for vaginal pressure measurement , a Mercury sphygmomanometer was used as a gold standard , and for abdominal wall muscle activity , a standard biofeedback machine was used as a reference device .


A randomized , controlled trial was conducted in sixty-one women with stress urinary incontinence .


They were randomly divided into two groups undergoing PFMT with a single 15-minute biofeedback session ( BF + PFMT group ) or without biofeedback ( PFMT group ) .


The pelvic floor muscle strength , abdominal wall muscle activity and incontinence-specific quality of life questionnaire ( I-QOL ) , measurements were evaluated at baseline and at 8 - and 16-week after treatment .


The accuracy of vaginal probe pressure perineometry was 98 % compared to a standard sphygmomanometer .


The device could detect abdominal wall muscles activities at 10 milliseconds ( 100 Hz ) , 20 milliseconds ( 50 Hz ) , and 50 milliseconds ( 20 Hz ) .


After 8 and 16 weeks of treatment , there were statistically significant intra-group differences in the maximum vaginal squeeze pressure in both groups .


However , the inter-group differences were not demonstrated .


The proportion of women who performed pelvic floor muscle exercise correctly was significantly higher in the BF + PFMT group ( 72.41 % ) compared to the PFMT group ( 21.88 % ) at week 16 ( p < 0.05 ) .


The simple pelvic floor muscle strength evaluation device might be helpful in pelvic floor muscle training in a low resource setting .


Left ventricular ( LV ) dysfunction during and after hospitalization for ST-segment elevation myocardial infarction ( STEMI ) is associated with increased mortality .


Whether baseline LV dysfunction impacts STEMI outcomes is not well studied .


Furthermore , whether bivalirudin and paclitaxel-eluting stents ( PES ) are beneficial in patients with LV dysfunction is unknown .


We studied the impact of left ventricular ejection fraction ( LVEF ) on outcomes of patients with STEMI in the HORIZONS-AMI trial .


LVEF was determined in 2648 ( 73.5 % ) of 3602 enrolled STEMI patients , who were divided into three groups according to LV function : ( 1 ) severely impaired ( LVEF < 40 % ) ; ( 2 ) moderately impaired ( LVEF 40-50 % ) ; and ( 3 ) normal ( LVEF 50 % ) .


Compared to patients with normal LV function , those with severely impaired LVEF had higher 1-year rates of net adverse clinical events ( 27.1 vs. 14.2 % , p < 0.0001 ) , major adverse cardiovascular events ( 20.7 vs. 9.5 % , p < 0.0001 ) , cardiac death ( 10.6 vs. 1.2 % , p < 0.0001 ) , and non-coronary artery bypass graft major bleeding ( 12.5 vs. 6.6 % , p = 0.001 ) , differences which persisted after adjustment for baseline characteristics .


Among patients with LVEF < 40 % , treatment with bivalirudin compared to heparin + GPIIb/IIIa inhibitors resulted in reduced 1-year mortality ( 5.8 vs. 18.3 % , p = 0.007 ) .


Patients with LVEF < 40 % receiving PES rather than bare metal stents had lower rates of 1-year ischaemia-driven target lesion revascularization ( 2.9 vs. 12.6 % , p = 0.02 ) and reinfarction ( 4.5 vs. 14.7 % , p = 0.03 ) .


Among patients with STEMI undergoing primary percutaneous coronary intervention , adverse events are markedly increased in those with LVEF < 40 % during the index revascularization procedure .


Nevertheless , these high-risk patients experience substantial clinical benefits from bivalirudin and PES .


Increased intracranial pressure ( ICP ) in patients with traumatic brain injury ( TBI ) is associated with a higher mortality rate and poor outcome .


Mannitol and hypertonic saline ( HTS ) have both been used to treat high ICP , but it is unclear which one is more effective .


Here , the authors compare the effect of mannitol versus HTS on lowering the cumulative and daily ICP burdens after severe TBI .


The Brain Trauma Foundation TBI-trac New York State database was used for this retrospective study .


Patients with severe TBI and intracranial hypertension who received only 1 type of hyperosmotic agent , mannitol or HTS , were included .


Patients in the 2 groups were individually matched for Glasgow Coma Scale score ( GCS ) , pupillary reactivity , craniotomy , occurrence of hypotension on Day 1 , and the day of ICP monitor insertion .


Patients with missing or erroneous data were excluded .


Cumulative and daily ICP burdens were used as primary outcome measures .


The cumulative ICP burden was defined as the total number of days with an ICP of > 25 mm Hg , expressed as a percentage of the total number of days of ICP monitoring .


The daily ICP burden was calculated as the mean daily duration of an ICP of > 25 mm Hg , expressed as the number of hours per day .


The numbers of intensive care unit ( ICU ) days , numbers of days with ICP monitoring , and 2-week mortality rates were also compared between the groups .


A 2-sample t-test or chi-square test was used to compare independent samples .


The Wilcoxon signed-rank or Cochran-Mantel-Haenszel test was used for comparing matched samples .


A total of 35 patients who received only HTS and 477 who received only mannitol after severe TBI were identified .


Eight patients in the HTS group were excluded because of erroneous or missing data , and 2 other patients did not have matches in the mannitol group .


The remaining 25 patients were matched 1:1 .


Twenty-four patients received 3 % HTS , and 1 received 23.4 % HTS as bolus therapy .


All 25 patients in the mannitol group received 20 % mannitol .


The mean cumulative ICP burden ( 15.52 % [ HTS ] vs 36.5 % [ mannitol ] ; p = 0.003 ) and the mean ( SD ) daily ICP burden ( 0.3 0.6 hours/day [ HTS ] vs 1.3 1.3 hours/day [ mannitol ] ; p = 0.001 ) were significantly lower in the HTS group .


The mean ( SD ) number of ICU days was significantly lower in the HTS group than in the mannitol group ( 8.5 2.1 vs 9.8 0.6 , respectively ; p = 0.004 ) , whereas there was no difference in the numbers of days of ICP monitoring ( p = 0.09 ) .


There were no significant differences between the cumulative median doses of HTS and mannitol ( p = 0.19 ) .


The 2-week mortality rate was lower in the HTS group , but the difference was not statistically significant ( p = 0.56 ) .


HTS given as bolus therapy was more effective than mannitol in lowering the cumulative and daily ICP burdens after severe TBI .


Patients in the HTS group had significantly lower number of ICU days .


The 2-week mortality rates were not statistically different between the 2 groups .


This prospective , randomized phase III intergroup trial of the Gynecologic Oncology Group and National Cancer Institute of Canada Clinical Trials Group was designed to test the effectiveness and safety of adding the hypoxic cell sensitizer tirapazamine ( TPZ ) to standard cisplatin ( CIS ) chemoradiotherapy in locally advanced cervix cancer .


Patients with locally advanced cervix cancer were randomly assigned to CIS chemoradiotherapy versus CIS/TPZ chemoradiotherapy .


Primary end point was progression-free survival ( PFS ) .


Secondary end points included overall survival ( OS ) and tolerability .


PFS was evaluable in 387 of 402 patients randomly assigned over 36 months , with enrollment ending in September 2009 .


Because of the lack of TPZ supply , the study did not reach its original target accrual goal .


At median follow-up of 28.3 months , PFS and OS were similar in both arms .


Three-year PFS for the TPZ/CIS/RT and CIS/RT arms were 63.0 % and 64.4 % , respectively ( log-rank P = .7869 ) .


Three-year OS for the TPZ/CIS/RT and CIS/RT arms were 70.5 % and 70.6 % , respectively ( log-rank P = .8333 ) .


A scheduled interim safety analysis led to a reduction in the starting dose for the TPZ/CIS arm , with resulting tolerance in both treatment arms .


TPZ/CIS chemoradiotherapy was not superior to CIS chemoradiotherapy in either PFS or OS , although definitive commentary was limited by an inadequate number of events ( progression or death ) .


TPZ/CIS chemoradiotherapy was tolerable at a modified starting dose .


We describe the statistical analysis plan ( SAP ) for the Permissive Hyperthermia through Avoidance of Paracetamol in Known or Suspected Infection in the Intensive Care Unit ( HEAT ) trial , a 700-patient , prospective , randomised , Phase 2b , multicentre , double-blind , parallel-groups , placebo-controlled trial of paracetamol administration for the treatment of fever in critically ill patients with known or suspected infection .


The data fields described are those outlined in the study protocol published previously .


We describe the plan for the presentation and comparison of baseline characteristics , process measures and outcomes .


We describe baseline characteristics , and define and categorise trial outcomes according to their assigned importance .


We developed an SAP for the HEAT trial , and produced a mock Consolidated Standards of Reporting Trials diagram and tables .


Our prespecified SAP accords with high-quality standards of internal validity and should minimise future analysis bias .


To examine the effect of an individually tailored , motivationally matched prenatal exercise intervention on gestational diabetes mellitus ( GDM ) and other measures of glucose intolerance among ethnically diverse prenatal care patients at increased risk for GDM .


The Behaviors Affecting Baby and You study randomized eligible women at a mean ( standard deviation ) of 18.2 ( 4.1 ) weeks of gestation to a 12-week individually tailored , motivationally matched exercise intervention or a comparison health and wellness intervention .


The goal of the exercise intervention was to achieve the American College of Obstetricians and Gynecologists ' guidelines for physical activity during pregnancy .


Diagnosis of GDM , impaired glucose tolerance , abnormal glucose screen , and screening glucose values ( mg/dL ) were abstracted from medical records .


A sample size of 352 women ( 176 per group ) was planned to have 80 % power to detect reductions in risk of 35 % or larger .


From July 2007 to December 2012 , a total of 251 ( 86.5 % ) women completed the intervention ; n = 124 and 127 in the exercise and comparison interventions , respectively .


Based on an intention-to-treat analysis , no statistically significant differences between the intervention groups were observed ; the relative odds of GDM in the exercise group was 0.61 ( 95 % confidence interval [ CI ] 0.28-1 .32 ) as compared with the health and wellness comparison group .


Odds ratios for impaired glucose tolerance and abnormal glucose screen were 0.68 ( 95 % CI 0.35-1 .34 ) and 0.86 ( 95 % CI 0.51-1 .47 ) , respectively .


The intervention had no effect on birth outcomes .


In this randomized trial among ethnically diverse pregnant women at increased risk for GDM , we found that a prenatal exercise intervention implemented in the second trimester did not result in a statistically significant reduction in relative odds for GDM , impaired glucose tolerance , or abnormal glucose screen .


I.


Prospective , multicenter , randomized , and controlled Investigational Device Exemption clinical trial .


To compare the clinical safety and effectiveness of the selectively constrained SECURE-C ( Globus Medical , Audubon , PA ) Cervical Artificial Disc to anterior cervical discectomy and fusion ( ACDF ) .


Cervical total disc replacement has been developed as an alternative to ACDF by allowing segmental motion .


Current cervical total disc replacement designs incorporate constrained and unconstrained metal-on-metal or metal-on-polymer articulating designs with various means of fixation .


A total of 380 patients from 18 investigational sites were prospectively enrolled in the study .


Patients were randomized , treated surgically , and evaluated postoperatively at 6 weeks , 3 months , 6 months , 12 months , and 24 months .


Clinical outcomes include overall success , visual analogue scale pain ( right arm , left arm , and neck ) , neck disability index , neurological status , Short Form 36 ( SF-36 ) Health Status Survey questionnaires , range of motion , and adverse events .


Bayesian statistical methods were used to analyze the outcomes .


Overall success results demonstrated statistical superiority of the randomized SECURE-C group compared with the randomized ACDF group at 24 months , with a posterior probability of 100 % using the protocol-specified criteria and 98.1 % using Food and Drug Administration-defined criteria .


At 24 months postoperatively , SECURE-C demonstrated clinically significant improvement in pain and function in terms of neck disability index , visual analogue scale , and 36-Item Short Form Health Survey .


At 24 months , the percentage of patients experiencing secondary surgical interventions at the index level was statistically lower for the SECURE-C group ( 2.5 % ) than the ACDF group ( 9.7 % ) .


At 24 months , 84.6 % of as-treated SECURE-C patients were range-of-motion successes .


Satisfaction was high among SECURE-C patients .


The selectively constrained SECURE-C Cervical Artificial Disc is as safe and effective as the standard of care , an anterior cervical discectomy and fusion .


SECURE-C is statistically superior in terms of overall success , index-level subsequent surgical procedures , and patient satisfaction , making it an attractive surgical option for patients with symptomatic cervical disc disease .


1 .