In pre-specified analyses , stroke , bleeding , and death that occurred through @ days after the end-of-trial visit were stratified by randomized treatment allocation and open-label anticoagulant selected post-trial .


Of the @,@ patients taking the blinded study drug at the end of the trial , @,@ ( @ % ) were transitioned to open-label VKA and @,@ patients ( @ % ) to an NOAC .


There were @ strokes evenly distributed across the @ randomized treatment arms : warfarin @ ( @ % / year ) , edoxaban high dose @ ( @ % / year ) , edoxaban low dose @ ( @ % / year ) .


Major bleeding was also similar across the @ treatment arms : warfarin @ ( @ % / year ) , edoxaban high dose @ ( @ % / year ) , edoxaban low dose @ ( @ % / year ) .


In patients transitioned to VKA , @ % of patients had at least @ INR @ by day @ after the transition and @ % by day @ .


The ENGAGE AF-TIMI @ transition plan protected patients from an excess of thrombotic and bleeding events and should be helpful in clinical practice when patients are transitioned between oral anticoagulants .


( Global Study to Assess the Safety and Effectiveness of Edoxaban -LSB- DU-@b -RSB- vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation -LSB- EngageAFTIMI@ -RSB- ; NCT@ ) .


This prospective multicenter study examined whether elevated fecal calprotec tin ( FC ) concentrations after stopping TNF-blocking therapy can predict clinical or endoscopic relapse .


In addition , we evaluated the impact of histological remission on the relapse risk .


We enrolled inflammatory bowel disease ( IBD ) patients who were in clinical , endoscopic , and FC-based ( < @ g/g ) remission after a minimum @ months of TNF-blocking therapy .


The patients were followed-up for @ months after the discontinuation of TNF-blocking therapy .


FC was collected monthly for the first @ months and thereafter every second month .


Ileocolonoscopy was performed at inclusion , at @ months , at the study end , and at the time of clinical relapse .


Of @ enrolled patients , @ ( @ Crohn 's disease , @ ulcerative colitis/IBD unclassified ) provided the stool samples requested and comprised the study group .


During the follow-up , @/@ ( @ % ) relapsed , whereas @ ( @ % ) remained in remission .


Patients relapsing showed constantly elevated FC levels for a median of @ ( @-@ ) days before the relapse .


Significant increase in median FC levels was seen @ ( p = @ ) , @ ( p = @ ) , and @ ( p = @ ) months before endoscopic relapse .


Constantly normal FC concentrations during the follow-up were highly predictive for clinical and endoscopic remission .


Normal FC concentrations in patients with remission were associated with histological remission .


FC seems to increase and remain elevated before clinical or endoscopic relapse , suggesting that it can be used as a surrogate marker for predicting and identifying patients requiring close follow-up in clinical practice .


Experimental pain models in human healthy volunteers are advantageous for early evaluation of analgesics .


All efforts to develop nonsteroidal anti-inflammatory drugs ( NSAIDs ) which are devoid of gastrointestinal and cardiovascular system effects are still far from achieving a breakthrough .


Hence we evaluated the analgesic activity of an ayurvedic drug , Boswellia serrata by using validated human pain models which has shown its analgesic activity both in-vitro and preclinical studies to evaluate the analgesic activity of single oral dose ( @ mg , @ capsules ) of Boswellia serrata compared to placebo using mechanical pain model in healthy human subjects .


After taking written informed consent , twelve healthy subjects were randomized ( @:@ ) to receive single oral dose of Boswellia serrata ( Shallaki ( ) ) @ mg , @ capsules or identical placebo in a crossover design .


Mechanical pain was assessed using Ugo basile analgesymeter ( by Randall Selitto test ) at baseline and at @ hr , @ hrs and @ hrs after test drug administration .


Pain Threshold force and time and Pain Tolerance force and time were evaluated .


Statistical analysis was done by paired t-test .


Twelve healthy volunteers have completed the study .


Mean percentage change from baseline in Pain Threshold force and time with Boswellia serrata when compared to placebo had significantly increased -LSB- Force : @ @ vs @ @ ( P = @ ) and time : @ @ vs @ @ ( P = @ ) -RSB- at third hr .


Mean Percentage change from baseline in Pain Tolerance force and time with Boswellia serrata when compared to placebo had significantly ( P @ ) increased at @ hr , @ hrs and @ hrs .


In the present study , Boswellia serrata significantly increased the Pain Threshold and Pain Tolerance force and time compared to placebo .


Both study medications were well tolerated .


Further multiple dose studies may be needed to establish the analgesic efficacy of the drug .


First - and second-year medical students have limited exposure to basic surgical skills .


An introductory , comprehensive , simulation-based curriculum in basic laparoscopic skills may improve medical students ' knowledge and technical and nontechnical skills and may raise their interest in a career in surgery .


The purpose of this study was to ( @ ) design a comprehensive , simulation-based training curriculum ( STC ) aimed to introduce junior medical students to basic laparoscopic skills and ( @ ) compare structured and supervised learning and practice to a self-directed approach .


Twenty-four , pre-clerkship medical students were allocated randomly to either a supervised ( STC ) or a self-directed learning and practice ( SDL ) group .


Participants in the STC group received structured training in cognitive , and basic technical and nontechnical domains of laparoscopic surgery , whereas the SDL group was invited to engage in SDL in the same domains .


At post-training assessment , basic knowledge about laparoscopic surgery , and attitudes toward nontechnical skills were equivalent between STC and SDL groups .


The STC group outperformed ( meanstandard deviation ) the SDL group on a peg transfer task ( @ vs @seconds ; P = @ ) .


Participants in the STC group showed significant within-group improvements in knowledge , technical skill , and in @ of @ domains of nontechnical skills , whereas participants in the SDL group showed significant within-group improvement in technical skill and in @ of @ domains of nontechnical skills .


Participation in the STC resulted in significant gains in knowledge , technical skill , and attitudes toward nontechnical skills .


Exposure of junior medical students to this curriculum before their clinical rotations is expected to enhance learning , maintain motivation , and increase interest in surgery as a future career .


Tricuspid annular plane systolic excursion ( TAPSE ) is a widely used clinical measure of right ventricular ( RV ) systolic performance .


However , postsurgical changes in the pattern of RV contraction may limit the utility of TAPSE for assessing global RV function .


We retrospectively examined pre - and postoperative TAPSE and RV fractional area change ( FAC ) in patients undergoing @ different types of aortic valve replacement ( AVR ) .


Fifty-two patients enrolled in the Placement of AoRTic TraNscathetER Valve Trial at our institution were randomized to receive open AVR or transcatheter AVR ( TAVR ) by either the transapical or transfemoral access routes .


Thirty-seven of these patients had analyzable transthoracic echocardiography ( TTE ) before and after AVR .


Using M-mode echocardiography , TAPSE was measured in the apical four-chamber view .


Using two-dimensional echocardiography , RV FAC was measured in the apical four-chamber view .


The mean change in TAPSE was -@ cm for open AVR ( P = @ ) , -@ cm for transapical TAVR ( P = @ ) , and @ cm for transfemoral TAVR ( P = @ ) .


The mean change in RV FAC was -@ % for open AVR ( P = @ ) , @ % for transapical TAVR ( P = @ ) , and @ % for transfemoral TAVR ( P = @ ) .


The normal pattern of RV contraction was unchanged by transapical and transfemoral TAVR , while open AVR led to a significant decrease in TAPSE with preserved RV FAC .


Thus , RV FAC is a preferable method for assessing RV function in the postoperative patient .


The objective of this @-arm parallel single-center trial was to compare placement time and numbers of failures of mandibular lingual retainers bonded with an indirect procedure vs a direct bonding procedure .


Sixty-four consecutive patients at the postgraduate orthodontic clinic of the University of Geneva in Switzerland scheduled for debonding and mandibular fixed retainer placement were randomly allocated to either an indirect bonding procedure or a traditional direct bonding procedure .


Eligibility criteria were the presence of the @ mandibular incisors and the @ mandibular canines , and no active caries , restorations , fractures , or periodontal disease of these teeth .


The patients were randomized in blocks of @ ; the randomization sequence was generated using an online randomization service ( www.randomization.com ) .


Allocation concealment was secured by contacting the sequence generator for treatment assignment ; blinding was possible for outcome assessment only .


Bonding time was measured for each procedure .


Unpaired t tests were used to assess differences in time .


Patients were recalled at @ , @ , @ , and @months after bonding .


Mandibular fixed retainers having at least @ composite pad debonded were considered as failures .


The log-rank test was used to compare the Kaplan-Meier survival curves of both procedures .


A test of proportion was applied to compare the failures at @months between the treatment groups .


Sixty-four patients were randomized in a @:@ ratio .


One patient dropped out at baseline after the bonding procedure , and @ patients did not attend the recalls at @ and @months .


Bonding time was significantly shorter for the indirect procedure ( @seconds , meanSD ) than for the direct procedure ( @seconds ) ( per protocol analysis of @ patients : mean difference = @seconds ; @ % CI = @-@ @ ; P < @ ) .


The @-month numbers of failures were @ of @ ( @ % ) with the indirect technique and @ of @ ( @ % ) with the direct technique ( log rank : P = @ ; test of proportions : risk difference = @ ; @ % CI = -@ to @ ; P = @ ) .


No serious harm was observed except for plaque accumulation .


Indirect bonding was statistically significantly faster than direct bonding , with both techniques showing similar risks of failure .


This trial was not registered .


The protocol was not published before trial commencement .


Internal nasal valve collapse is a preventable complication of rhinoplasty , for which the spreader graft is the gold standard .


More recently , the spreader flap technique has been espoused as an alternative to spreader grafting .


Here , we evaluated the efficacy of this technique in a randomized trial setting .


The autospreader was used in @ patients who were candidates for primary rhinoplasty ; @ who did not undergo a spreader flap procedure were recruited as a control group .


Acoustic rhinometry was used in every patient preoperatively and @ year postoperatively .


Average volume and minimal cross-sectional area ( MCA ) of the nose and findings were collected .


Also , the pre - and postoperative patients ' subjective assessment about their satisfaction from their appearance and nasal obstruction were evaluated according to visual analog scale ( VAS ) .


Among the study group patients , @ ( @ % ) were female and @ ( @ % ) were male subjects .


Their mean age was @/@ @/@ years .


The difference in MCA in the control group was -@ and +@ ( on right and left sides , respectively ) , and in the spreader flap group it was -@ and +@ , which showed an increase in MCA in the left side and a decrease in the opposite side of both groups .


However , their difference was not statistically significant ( p = @ ) .


Also , the differences between preoperative and postoperative VAS were not significant in either nasal obstruction ( p = @ ) and cosmetic satisfaction ( p = @ ) .


Spreader flap is an attractive technique in preserving the middle vault in nasal plastic surgery .


However , its effect needs more evaluation .


The Protocolized Care for Early Septic Shock study is a randomised , multicentre , prospective , three-arm , parallel-group trial of alternative resuscitation strategies for early septic shock .


To state our analysis plan for trial data .


Our plan is to guide data collection and analysis using pre-existing definitions and testing , with local consensus-based efforts where needed .


We examine protocolised care ( two experimental approaches ) and compare this to usual `` wild type '' care .


Our plan is to address three aims ( clinical efficacy , biology of illness and recovery , and costs and cost-effectiveness ) and four hypotheses , and we specify rules for handling data and determining outcomes .


By using measures to maintain study conduct and analysis rigour , we hope to improve understanding of early septic shock resuscitation and care of patients .


Cluster randomized trials ( CRTs ) are increasingly used to evaluate quality improvement interventions aimed at health care providers .


In trials testing emergency department ( ED ) interventions , migration of emergency physicians ( EPs ) between hospitals is an important concern , as contamination may affect both internal and external validity .


We hypothesized that geographically isolating EDs would prevent migratory contamination in a CRT designed to increase ED delivery of tissue plasminogen activator ( tPA ) in stroke ( the INSTINCT trial ) .


INSTINCT was a prospective , cluster randomized , controlled trial .


Twenty-four Michigan community hospitals were randomly selected in matched pairs for study .


Contamination was defined at the cluster level , with substantial contamination defined a priori as greater than @ % of EPs affected .


Nonadherence , total crossover ( contamination + nonadherence ) , migration distance , and characteristics were determined .


Three hundred seven EPs were identified at all sites .


Overall , @ ( @ % ) changed study sites .


One moved between control sites , leaving @ ( @ % ) total crossovers .


Of these , @ ( @ % ) moved from intervention to control ( contamination ) ; and @ ( @ % ) moved from control to intervention ( nonadherence ) .


Contamination was observed in @ of @ control sites , with @ % and @ % contamination of the total site EP workforce at follow-up , respectively .


Average migration distance was @ miles for all EPs moving in the study and @ miles for EPs moving from intervention to control sites .


The mobile nature of EPs should be considered in the design of quality improvement CRTs .


Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design .


To investigated the effect of a hyperoncotic CPB-prime with hydroxyethyl starch ( HES ) @ % ( @/@ @ ) on extravascular lung water ( EVLW ) and post-pump cardiac and pulmonary functions .


This study plan approved by the hospital ethics committee review .


In @ randomized patients undergoing elective coronary artery bypass graft surgery ( CABG ) , a colloid prime ( COP :@ mmHg , HES-group , n = @ ) and a crystalloid prime ( Ringer 's lactate , crystalloid group , n = @ ) of equal volume were compared with respect to the effects on cardiopulmonary function .


Cardiac index ( CI ) , mean arterial pressure ( MAP ) , pulmonary capillary wedge pressure ( PCWP ) , systemic vascular resistance index ( SVRI ) , pulmonary artery pressure ( PAP ) , pulmonary vascular resistance index ( PVRI ) , alveolo-arterial oxygen difference ( AaDO@ ) , pulmonary shunt fraction ( Qs/QT ) , extravascular lung water ( EVLW ) , COP , fluid balance and body weight were evaluated peri-operatively .


Pre-operative demographic and clinical data , CPB-time , crossclamp time and the number of anastomoses were comparable for both groups .


During CPB , COP was reduced by @ % in the HES-group -LSB- ( @ @ ) vs ( @ @ ) mmHg , P < @ -RSB- while it was reduced by more than @ % of the pre-CPB value -LSB- @ @ vs ( @ @ ) mmHg , P < @ -RSB- in the crystalloid group ( P < @ HES-group vs. crystalloid group ) .


Post-CPB EVLW was unchanged in the HES-group but it was elevated by @ % in the crystalloid group ( P < @ HES-group vs crystalloid group ) , CI was higher in the HES-group -LSB- ( @ @ ) vs ( @ @ ) L/min , P < @ -RSB- .


Fluid balance was less in the HES-group ( @ @ vs @ @ @ , P < @ ) .


Post-operative weight gain could be prevented in the HES-group but not in the crystalloid group ( @ @ vs -@ @ , P < @ ) .


No significant differences were seen for MAP , PAP , PCWP , SVRI , PVRI , AaDO@ and ( Qs/QT ) between the two groups at any time .


Hyperoncotic CPB-prime using HES @ % improves CI and prevents EVLW accumulation in the early post-pump period , while pulmonary function is unchanged .


Schizophrenia is a highly heterogeneous disorder with positive and negative symptoms being characteristic manifestations of the disease .


While these two symptom domains are usually construed as distinct and orthogonal , little is known about the longitudinal pattern of negative symptoms and their linkage with the positive symptoms .


This study assessed the temporal interplay between these two symptom domains and evaluated whether the improvements in these symptoms were inversely correlated or independent with each other .


This post hoc analysis used data from a multicenter , randomized , open-label , @-year pragmatic trial of patients with schizophrenia spectrum disorder who were treated with first - and second-generation antipsychotics in the usual clinical settings .


Data from all treatment groups were pooled resulting in @ patients with complete data on both the negative and positive subscale scores from the Positive and Negative Syndrome Scale ( PANSS ) .


Individual-based growth mixture modeling combined with interplay matrix was used to identify the latent trajectory patterns in terms of both the negative and positive symptoms .


Pearson correlation coefficients were calculated to examine the relationship between the changes of these two symptom domains within each combined trajectory pattern .


We identified four distinct negative symptom trajectories and three positive symptom trajectories .


The trajectory matrix formed @ combined trajectory patterns , which evidenced that negative and positive symptom trajectories moved generally in parallel .


Correlation coefficients for changes in negative and positive symptom subscale scores were positive and statistically significant ( P < @ ) .


Overall , the combined trajectories indicated three major distinct patterns : ( @ ) dramatic and sustained early improvement in both negative and positive symptoms ( n = @ , @ % ) , ( @ ) mild and sustained improvement in negative and positive symptoms ( n = @ , @ % ) , and ( @ ) no improvement in either negative or positive symptoms ( n = @ , @ % ) .


This study of symptom trajectories over @ year shows that changes in negative and positive symptoms were neither inversely nor independently related with each other .


The positive association between these two symptom domains supports the notion that different symptom domains in schizophrenia may depend on each other through a unified upstream pathological disease process .


Depression symptoms are now recognized to be the predominant cause of disability for bipolar disorder ( BD ) patients .


The treatment strategies for the depressed phase of BD remain more anecdotal than data-based .


Olanzapine has been investigated as an alternative to antidepressants and a mood stabilizer for acute bipolar depression .


The purpose of this study was to assess the efficacy of olanzapine monotherapy for bipolar I depression .


Sixty-eight patients with bipolar I depression were randomly assigned to treatment with olanzapine ( mean final dose @ mg/day ) ( n = @ ) or placebo ( n = @ ) in a double-blind parallel-group study design .


Planned assessments included Montgomery-Asberg Depression Rating Scale ( MADRS ) , Young Mania Rating Scale ( YMRS ) , Clinical Global Impressions-Severity of Illness scale ( CGI-S ) , Clinical Global Impressions-Improvement scale ( CGI-I ) , Hamilton Depression scale ( HAMD ) , Hamilton Anxiety scale ( HAMA ) , and Treatment Emergent Symptom Scale ( TESS ) .


Of the @ patients who were randomly assigned , @ ( @ % ) completed treatments .


Improvements in MADRS total score , CGI-S , CGI-I , and HAMD in the olanzapine group were significantly greater relative to those in the placebo group during the @-week follow-up period ( p < @ , p = @ , p = @ , and p < @ , respectively ) .


Rates of categorical treatment response and remission in the olanzapine group ( @ % and @ % , respectively ) were significantly higher than those in the placebo group ( @ % , p = @ and @ % , p = @ , respectively ) .


At the @-week treatment , the mean weight and the total cholesterol , triglyceride , and low-density lipoprotein cholesterol levels increased significantly in the olanzapine group ( p = @ , p = @ , p = @ , and p = @ , respectively ) .


Olanzapine is effective in the treatment of bipolar I depression but is associated with significant metabolic side effects .


Metformin treatment is associated with improved outcome after myocardial infarction in patients with diabetes .


In animal experimental studies metformin preserves left ventricular function .


To evaluate the effect of metformin treatment on preservation of left ventricular function in patients without diabetes presenting with ST-segment elevation myocardial infarction ( STEMI ) .


Double-blind , placebo-controlled study conducted among @ patients who underwent primary percutaneous coronary intervention ( PCI ) for STEMI at the University Medical Center Groningen , The Netherlands , between January @ , @ , and May @ , @ .


Metformin hydrochloride ( @ mg ) ( n = @ ) or placebo ( n = @ ) twice daily for @ months .


The primary efficacy measure was left ventricular ejection fraction ( LVEF ) after @ months , assessed by magnetic resonance imaging .


A secondary efficacy measure was the N-terminal pro-brain natriuretic peptide ( NT-proBNP ) concentration after @ months .


The incidence of major adverse cardiac events ( MACE ; the combined end point of death , reinfarction , or target-lesion revascularization ) was recorded until @ months as a secondary efficacy measure .


At @ months , all patients were alive and none were lost to follow-up .


LVEF was @ % ( @ % CI , @ % -@ % ) in the metformin group ( n = @ ) , compared with @ % ( @ % CI , @ % -@ % ) ( P = @ ) in the placebo group ( n = @ ) .


NT-proBNP concentration was @ ng/L in the metformin group ( interquartile range -LSB- IQR -RSB- , @-@ ng/L ) and @ ng/L in the placebo group ( IQR , @-@ ng/L ) ( P = @ ) .


MACE were observed in @ patients ( @ % ) in the metformin group and in @ patients ( @ % ) in the placebo group ( P = @ ) .


Creatinine concentration ( @ mol/L -LSB- IQR , @-@ mol/L -RSB- vs @ mol/L -LSB- IQR , @-@ mol/L -RSB- , P = @ ) and glycated hemoglobin ( @ % -LSB- IQR , @ % -@ % -RSB- vs @ % -LSB- IQR , @ % -@ % -RSB- , P = @ ) were not significantly different between both groups .


No cases of lactic acidosis were observed .


Among patients without diabetes presenting with STEMI and undergoing primary PCI , the use of metformin compared with placebo did not result in improved LVEF after @ months .


The present findings do not support the use of metformin in this setting .


This phase III , @-week study compared fostamatinib with placebo ( for @ weeks ) in patients with active rheumatoid arthritis ( RA ) and an inadequate response to methotrexate ( MTX ) therapy .


Patients taking MTX were randomized ( @:@:@ ) to receive fostamatinib @ mg twice daily for @ weeks ( group A ) , fostamatinib @ mg twice daily for @ weeks and then @ mg once daily ( group B ) , or placebo for @ weeks and then fostamatinib @ mg twice daily ( group C ) .


At week @ , the co-primary end points were change from baseline in the American College of Rheumatology @ % ( ACR@ ) improvement response rates and change in the modified total Sharp/van der Heijde score of radiographic damage ( SHS ) .


In this study , @ patients were randomized and received @ dose of study drug ( fostamatinib or placebo ) ; the demographic and baseline clinical characteristics were well balanced .


Following treatment with both fostamatinib regimens , a statistically significant difference in the ACR@ improvement response was achieved at week @ as compared with that in patients receiving placebo ( @ % -LSB- group A -RSB- and @ % , -LSB- group B -RSB- versus @ % ; P < @ and P = @ , respectively ) , but there was no statistically significant difference in the SHS between either fostamatinib group and placebo ( P = @ and P = @ , respectively ) .


The most common adverse events in patients in groups A , B , and C were hypertension ( @ % , @ % , and @ % , respectively ) and diarrhea ( @ % , @ % , and @ % , respectively ) .


Elevated blood pressure ( @/@ mm Hg ) occurred at @ visit in @ % , @ % , and @ % of patients in each respective group .


With the use of either fostamatinib regimen in patients with RA , statistically significant , but not clinically significant , improvements in the ACR@ improvement response over placebo were achieved at @ weeks , whereas a significant difference in the SHS was not seen .


The overall level of response to treatment with fostamatinib was lower than had been observed in the phase II program , but similar adverse events were reported .


Despite the use of evidence-based preventive measures , delirium affects about @ % of patients following cardiac surgery with the potential for serious clinical complications and anxiety for caregivers .


There is some evidence that family involvement as a core component of delirium management may be beneficial since familiarity helps patients stay in contact with reality , however , this merits further investigation .


There is also currently a gap in the scientific literature regarding objective indicators that could enhance early detection and monitoring of delirium .


Therefore , this randomized pilot trial examines the acceptability , feasibility , and preliminary efficacy of an experimental nursing intervention to help family caregivers manage post-cardiac surgery delirium in their relatives .


It also explores the validity of a new and innovative measure that has potential as an indicator for delirium .


In this two-group randomized pilot study ( n = @ ) , the control group will receive usual care and the intervention group will receive the experimental intervention aimed at reducing delirium severity .


The intervention nurse 's objective will be to foster the family caregiver 's self-efficacy in behaving in a supportive manner during delirium episodes .


Data will be collected from standard delirium assessment scales and a novel measure of delirium , i.e. , cerebral oximetry obtained using near infrared spectroscopy , as well as medical records and participants ' responses to questionnaires .


New strategies for early detection , monitoring , and management of delirium are needed in order to improve outcomes for both patients and families .


The present article exposes feasibility issues based on the first few months of the empirical phase of the study that may be useful to the scientific community interested in improving the care of patients with delirium .


Another potentially important contribution is in the exploration of cerebral oximetry , a promising measure as an objective indicator for early detection and continuous monitoring of delirium .


The proposed pilot study will build towards a larger trial with the potential to improve knowledge about delirium management and monitoring .


To compare the effect of @ seconds versus @ minutes brushing on saliva and dental biofilm fluid fluoride in children ages @-@ years over @ hour .


This was a single-blind , cross-over , randomised , two-period clinical study in healthy children .


Three days before the start of each treatment subjects received a thorough brushing and then refrained from all oral hygiene procedures .


At treatment visits , after collecting baseline biofilm and saliva samples , staff brushed the occlusal surfaces of the subject 's posterior teeth with a pea-sized amount ( @ g ) of NaF/silica toothpaste for the randomised time .


Samples were taken at @ minutes , @ minutes , @ minutes and @ minutes after brushing and analysed for fluoride using a microanalytical methodology .


There was a minimum @-day washout period between treatments .


Log changes from baseline biofilm fluid and saliva fluoride were statistically significant ( P < @ ) for both brushing times at all post-brushing time-points -LSB- except @ minutes saliva where P = @ ( t-test ) -RSB- .


Statistically significantly greater ln-AUC ( area under the curve ) was found for biofilm fluid and salivary fluoride after brushing for @ minutes compared with brushing for @ seconds over the @-hour test period .


There was a statistically significantly higher concentration of fluoride in the log change from baseline saliva levels after @ , @ , @ and @ minutes for the @-minute brushing time compared with @ seconds brushing time .


There was no statistically significant difference in concentration of log change from baseline fluoride levels in biofilm fluid at each individual time-point ( @ , @ , @ and @ minutes ) for the @-minute brushing time compared with the @-second brushing time , but significant differences were observed for @ , @ and @ minutes in favour of @-minute brushing time when log biofilm fluid value was analysed .


The findings provide further evidence for the benefits of increased duration of brushing with respect to fluoride delivery .


Repeated blood donation produces iron deficiency .


Changes in dietary iron intake do not prevent donation-induced iron deficiency .


Prolonging the interdonation interval or using oral iron supplements can mitigate donation-induced iron deficiency .


The most effective operational methods for reducing iron deficiency in donors are unknown .


` Strategies To Reduce Iron Deficiency ' ( STRIDE ) was a two-year , randomized , placebo-controlled study in blood donors .


@ donors were randomized into one of two educational groups or one of three interventional groups .


Donors randomized to educational groups either received letters thanking them for donating , or , suggesting iron supplements or delayed donation if they had low ferritin .


Donors randomized to interventional groups either received placebo , @-mg or @-mg iron pills .


Iron deficient erythropoiesis was present in @ % of males and @ % of females at enrolment .


Adverse events within @ days of enrolment were primarily mild gastrointestinal symptoms ( @ % ) .


The incidence of de-enrolment within @ days was more common in the interventional groups than in the educational groups ( P = @ ) , but not more common in those receiving iron than placebo ( P = @ ) .


The prevalence of iron deficient erythropoiesis in donors enrolled in the STRIDE study is comparable to previously described cohorts of regular blood donors .


De-enrolment within @ days was higher for donors receiving tablets , although no more common in donors receiving iron than placebo .


We investigated whether screen-detected and apparently asymptomatic adults with endomysial antibodies ( EmA ) benefit from a gluten-free diet ( GFD ) .


We performed a prospective trial of @ individuals at risk for celiac disease based on screens for EmA .


Of @ seropositive individuals , @ fulfilled inclusion criteria and were assigned randomly to groups placed on a GFD or gluten-containing diets .


We evaluated ratios of small-bowel mucosal villous height : crypt depth , serology and laboratory test results , gastrointestinal symptom scores , physiologic well-being , perception of health by a visual analog scale , bone mineral density , and body composition at baseline and after @ year .


Thereafter , the group on the gluten-containing diet started a GFD and was evaluated a third time ; subjects in the GFD group remained on this diet .


After @ year on the GFD , the mean mucosal villous height : crypt depth values increased ( P < @ ) , levels of celiac-associated antibodies decreased ( P < @ ) , and gastrointestinal symptoms improved to a greater extent than in patients on gluten-containing diets ( P = @ ) .


The GFD group also had reduced indigestion ( P = @ ) , reflux ( P = @ ) , and anxiety ( P = @ ) , and better health , based on the visual analog scale ( P = @ ) , than the gluten-containing diet group .


Only social function scores improved more in the gluten-containing diet group than in the GFD group ( P = @ ) .


There were no differences between groups in laboratory test results , bone mineral density , or body composition .


Most measured parameters improved when patients in the gluten-containing diet group were placed on GFDs .


No subjects considered their experience to be negative and most expected to remain on GFDs .


GFDs benefit asymptomatic EmA-positive patients .


The results support active screening of patients at risk for celiac disease .


Clinicaltrials.gov no : NCT@ .


Statin therapy reduces low-density lipoprotein ( LDL ) cholesterol levels and the risk of cardiovascular events , but whether the addition of ezetimibe , a nonstatin drug that reduces intestinal cholesterol absorption , can reduce the rate of cardiovascular events further is not known .


We conducted a double-blind , randomized trial involving @,@ patients who had been hospitalized for an acute coronary syndrome within the preceding @ days and had LDL cholesterol levels of @ to @ mg per deciliter ( @ to @ mmol per liter ) if they were receiving lipid-lowering therapy or @ to @ mg per deciliter ( @ to @ mmol per liter ) if they were not receiving lipid-lowering therapy .


The combination of simvastatin ( @ mg ) and ezetimibe ( @ mg ) ( simvastatin-ezetimibe ) was compared with simvastatin ( @ mg ) and placebo ( simvastatin monotherapy ) .


The primary end point was a composite of cardiovascular death , nonfatal myocardial infarction , unstable angina requiring rehospitalization , coronary revascularization ( @ days after randomization ) , or nonfatal stroke .


The median follow-up was @ years .


The median time-weighted average LDL cholesterol level during the study was @ mg per deciliter ( @ mmol per liter ) in the simvastatin-ezetimibe group , as compared with @ mg per deciliter ( @ mmol per liter ) in the simvastatin-monotherapy group ( P < @ ) .


The Kaplan-Meier event rate for the primary end point at @ years was @ % in the simvastatin-ezetimibe group , as compared with @ % in the simvastatin-monotherapy group ( absolute risk difference , @ percentage points ; hazard ratio , @ ; @ % confidence interval , @ to @ ; P = @ ) .


Rates of prespecified muscle , gallbladder , and hepatic adverse effects and cancer were similar in the two groups .


When added to statin therapy , ezetimibe resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes .


Moreover , lowering LDL cholesterol to levels below previous targets provided additional benefit .


( Funded by Merck ; IMPROVE-IT ClinicalTrials.gov number , NCT@ . )


Short-term physical activity ( PA ) has beneficial effects on symptom management and quality of life , however , longer-term adherence is likely needed for improved disease outcomes in breast cancer survivors ( BCS ) .


This study examined the effects of a supervised group exercise program on motivational outcomes and PA among BCS at @-year follow-up .


The original study was a two-armed , randomized controlled trial comparing a @-week supervised group exercise program to usual care among @ BCS .


BCS for this follow-up study were contacted at @ months postintervention and asked to complete assessments of motivational outcomes from the Theory of Planned Behavior and PA behavior using the Scottish Physical Activity Questionnaire .


Overall , @ participants provided @-year follow-up data with no differences in participation by group .


Analyses of covariance ( ANCOVAs ) revealed that supervised exercise had a significant positive effect on descriptive norm at @-year follow-up ( mean = +@ ; @ % CI = +@ to +@ ; d = +@ ; p = @ ) .


Small positive effects were also noted for perceived behavioral control ( d = +@ ) , instrumental attitude ( d = +@ ) , and injunctive norm ( d = +@ ) , although they were not statistically significant .


Moreover , BCS who were more active at @-year follow-up also reported more favorable perceived behavioral control ( d = +@ ) , instrumental attitude ( d = +@ ) , injunctive norm ( d = +@ ) , and descriptive norm ( d = +@ ) , although these differences were not statistically significant .


This trial provides suggestive evidence that a supervised exercise program has positive effects on motivational outcomes even after @ years .


Additional intervention strategies during follow-up may further improve long-term adherence and health outcomes in BCS .


To assess efficacy of the Foley catheter compared with the dinoprostone vaginal insert for beginning labor inductions at or near term .


We performed a multicenter randomized controlled trial .


We enrolled women at @ weeks of gestation or greater with a singleton live fetus in cephalic presentation , intact membranes , an unfavorable cervix ( dilation less than @ cm ; if @ cm , less than @ % effaced ) , and no contraindication to labor or either study agent .


Women were allocated to either a cervical Foley catheter inflated to @ mL or dinoprostone for up to @ hours .


Oxytocin was allowed only after study agent removal .


The primary outcome was time from agent placement to delivery .


Secondary outcomes included delivery by @ hours , vaginal delivery by @ hours , time to vaginal delivery , cesarean delivery rate , and rate of tachysystole .


Analysis was by intent-to-treat .


We enrolled @ patients , @ allocated to Foley catheter and @ to dinoprostone .


In the Foley catheter group , time to delivery was shorter ( median @ compared with @ hours ; P = @ ) , more patients delivered within @ hours ( @ % compared with @ % ; P = @ ) , more delivered vaginally within @ hours ( @ % compared with @ % ; P = @ ) , and time to vaginal delivery was shorter ( median @ compared with @ hours ; P = @ ) .


The cesarean delivery rates were @ % compared with @ % ( P = @ ) .


Uterine tachysystole occurred in @ % compared with @ % ( P = @ ) .


Starting labor inductions with a Foley catheter , compared with the dinoprostone vaginal insert , results in a shorter time to delivery and a higher proportion of women delivered and delivered vaginally within @ hours .


Cesarean delivery rates were not statistically significantly different .


The aim of this study was to explore the clinical utility of the clinical disease activity index ( CDAI ) .


We compared the disease control with protocolized treatment adjustment following a tight control strategy utilizing either the simplified disease activity index ( SDAI ) or the CDAI .


In a prospective @ month study , DMARD-naive RA patients were randomized to either a CDAI or SDAI arm and were treated with traditional DMARDs , increased on a monthly basis according to a predefined protocol to achieve low disease activity .


Of @ patients ( @ females , @ Black Africans ) , the mean symptom duration was @ years ( s.d. @ ) and the mean @-joint DAS ( DAS@ ) at baseline was @ ( s.d. @ ) .


By @ months , the proportion of patients in the CDAI and SDAI groups achieving low disease activity ( @ % and @ % ) and remission ( @ and @ % ) were similar .


There were no significant differences in the mean DAS@ or its components or in HAQ Disability Index or health-related quality of life scores .


Baseline predictors of low disease activity at @ months were shorter symptom duration ( P = @ ) and lower HAQ-DI score ( P = @ ) .


Given that the CDAI performed as well as the SDAI , and considering the cost savings and convenience because no acute phase reactant test is necessary , we suggest the CDAI may be an appropriate tool for monthly disease activity monitoring as part of a tight control strategy in developing countries .


Levels of measles in England and Wales are at their highest for @ years , and strategies targeting the different groups of parents who do not vaccinate their children continue to be needed .


Decision aids for decisions regarding childhood immunisation appear to be effective in achieving an increase in vaccine uptake but their cost effectiveness is unknown .


To assess the cost effectiveness of a web-based decision aid to increase uptake of the MMR vaccine .


Economic evaluation conducted alongside a cluster randomised controlled trial using urban GP practices in the north of England .


Fifty GP practices in the north of England were randomised to one of three trial arms : decision aid , leaflet , usual practice .


A total of @ first-time parents ( child aged @-@ months ) were recruited .


Parents self-reported their contacts with the NHS and other previous/expected resource utilisation ; associated costs were calculated .


Vaccine-uptake data were collected from GP practices .


A cost-effectiveness analysis was undertaken and provided the incremental cost per first-vaccine uptake .


Multiple imputation was used to account for missing data and findings were adjusted for baseline differences in parents ' levels of decisional conflict regarding MMR vaccination .


Of the @ first-time parents recruited to the study , @ completed the baseline and post-intervention questionnaires .


MMR uptake was highest for those receiving the decision aid ( @ out of @ , @ % ) versus usual practice ( @ out of @ , @ % ) and leaflet arm ( @ out of @ , @ % ) , and was associated with lower cost ( -@ versus usual practice and -@ versus leaflet ) .


The decision aid has a high chance of being cost effective , regardless of the value placed on obtaining additional vaccinations .


It also appears to offer an efficient means of decision support for parents .


The optimal chemotherapy regimen administered concurrently with preoperative radiation therapy ( RT ) for patients with rectal cancer is unknown .


National Surgical Adjuvant Breast and Bowel Project trial R-@ compared four chemotherapy regimens administered concomitantly with RT. .


Patients with clinical stage II or III rectal cancer who were undergoing preoperative RT ( @ Gy in @ fractions over @ weeks plus a boost of @ Gy to @ Gy in three to six daily fractions ) were randomly assigned to one of the following chemotherapy regimens : continuous intravenous infusional fluorouracil ( CVI FU ; @ mg/m ( @ ) , @ days per week ) , with or without intravenous oxaliplatin ( @ mg/m ( @ ) once per week for @ weeks ) or oral capecitabine ( @ mg/m ( @ ) twice per day , @ days per week ) , with or without oxaliplatin ( @ mg/m ( @ ) once per week for @ weeks ) .


Before random assignment , the surgeon indicated whether the patient was eligible for sphincter-sparing surgery based on clinical staging .


The surgical end points were complete pathologic response ( pCR ) , sphincter-sparing surgery , and surgical downstaging ( conversion to sphincter-sparing surgery ) .


From September @ to August @ , @,@ patients were randomly assigned .


No significant differences in the rates of pCR , sphincter-sparing surgery , or surgical downstaging were identified between the CVI FU and capecitabine regimens or between the two regimens with or without oxaliplatin .


Patients treated with oxaliplatin experienced significantly more grade @ or @ diarrhea ( P < @ ) .


Administering capecitabine with preoperative RT achieved similar rates of pCR , sphincter-sparing surgery , and surgical downstaging compared with CVI FU .


Adding oxaliplatin did not improve surgical outcomes but added significant toxicity .


The definitive analysis of local tumor control , disease-free survival , and overall survival will be performed when the protocol-specified number of events has occurred .


Dietary flaxseed lowers cholesterol in healthy subjects with mild biomarkers of cardiovascular disease ( CVD ) .


The aim was to investigate the effects of dietary flaxseed on plasma cholesterol in a patient population with clinically significant CVD and in those administered cholesterol-lowering medications ( CLMs ) , primarily statins .


This double-blind , randomized , placebo-controlled trial examined the effects of a diet supplemented for @ mo with foods that contained either @ g of milled flaxseed -LSB- milled flaxseed treatment ( FX ) group ; n = @ -RSB- or @ g of whole wheat -LSB- placebo ( PL ) group ; n = @ -RSB- in a patient population with peripheral artery disease ( PAD ) .


Plasma lipids were measured at @ , @ , @ , and @ mo. .


Dietary flaxseed in PAD patients resulted in a @ % reduction in circulating LDL cholesterol as early as @ mo into the trial ( P = @ ) .


The concentration in the FX group ( @ @ mmol/L ) tended to be less than in the PL group ( @ @ mmol/L ) at @ mo ( P = @ ) , but not at @ mo ( P = @ ) .


Total cholesterol also tended to be lower in the FX group than in the PL group at @ mo ( @ % , P = @ ) and @ mo ( @ % , P = @ ) , but not at @ mo ( P = @ ) .


In a subgroup of patients taking flaxseed and CLM ( n = @ ) , LDL-cholesterol concentrations were lowered by @ % @ % compared with baseline after @ mo. .


This differed from the PL + CLM subgroup ( n = @ ) , which increased by @ % @ % ( P = @ ) to a final concentration of @ @ mmol/L .


Milled flaxseed lowers total and LDL cholesterol in patients with PAD and has additional LDL-cholesterol-lowering capabilities when used in conjunction with CLMs .


This trial was registered at clinicaltrials.gov as NCT@ .


To evaluate pazopanib eye drops in patients with subfoveal choroidal neovascularisation secondary to age-related macular degeneration .


@ patients with minimally classic or occult subfoveal choroidal neovascularisation were randomly assigned to @ mg/mL TID , @ mg/mL TID , and @ mg/mL QD pazopanib eye drops for @ days in a multicentre , double-masked trial with an optional safety extension for up to @ additional months .


The primary outcomes were central retinal thickness ( CRT ) and best-corrected visual acuity ( BCVA ) at Day @ .


No significant decrease from baseline in CRT was observed overall ; however , an exploratory analysis showed improvement in CRT ( mean decrease of @ m ) in patients with the CFH TT genotype who received @ mg/mL TID ( p = @ , n = @ ) .


Mean increases in BCVA were observed in the @ mg/mL TID overall ( @ letters ( p = @ , n = @ ) ) and in those that with CFH Y@H TT ( @ letters ( p = @ , n = @ ) ) and CT ( @ letters ( p = @ , n = @ ) ) genotypes .


No safety signals that precluded continued investigation were detected .


@ mg/mL pazopanib eye drops resulted in mean improvement in BCVA at Day @ and improvements in vision .


However , improvement in macular oedema for age-related macular degeneration was found only in the subset of subjects with the CFH Y@H TT genotype , warranting further investigation .


In preclinical studies , davunetide promoted microtubule stability and reduced tau phosphorylation .


Because progressive supranuclear palsy ( PSP ) is linked to tau pathology , davunetide could be a treatment for PSP .


We assessed the safety and efficacy of davunetide in patients with PSP .


In a double-blind , parallel group , phase @/@ trial , participants were randomly assigned with permuted blocks in a @:@ ratio to davunetide ( @ mg twice daily , intranasally ) or placebo for @ weeks at @ centres in Australia , Canada , France , Germany , the UK , and the USA .


Participants met the modified Neuroprotection and Natural History in Parkinson Plus Syndrome study criteria for PSP .


Primary endpoints were the change from baseline in PSP Rating Scale ( PSPRS ) and Schwab and England Activities of Daily Living ( SEADL ) scale at up to @ weeks .


All participants and study personnel were masked to treatment assignment .


Analysis was by intention to treat .


The trial is registered with Clinicaltrials.gov , number NCT@ .


@ participants were randomly assigned to davunetide ( n = @ ) or to placebo ( n = @ ) , and @ ( @ % ) completed the study ( @ and @ in the davunetide and placebo groups , respectively ) .


There were no differences in the davunetide and placebo groups in the baseline PSPRS and SEADL .


The davunetide and placebo groups did not differ in the change from baseline in PSPRS ( median @ -LSB- @ % CI @ to @ -RSB- vs @ -LSB- @ to @ -RSB- , respectively , p = @ ) or SEADL ( -@ -LSB- -@ to -@ -RSB- vs -@ -LSB- -@ to -@ -RSB- , respectively , p = @ ) .


@ serious adverse events were reported in each of the treatment groups , including @ deaths in the davunetide group and ten in the placebo group .


The frequency of nasal adverse events was greater in the davunetide group than in the placebo group ( epistaxis @ -LSB- @ % -RSB- of @ vs @ -LSB- @ % -RSB- of @ , rhinorrhoea @ -LSB- @ % -RSB- vs eight -LSB- @ % -RSB- , and nasal discomfort @ -LSB- @ % -RSB- vs one -LSB- < @ % -RSB- ) .


Davunetide is not an effective treatment for PSP .


Clinical trials of disease-modifying treatment are feasible in patients with PSP and should be pursued with other promising tau-directed treatments .


To evaluate the efficacy and safety of intratympanic AM-@ in patients with persistent acute inner ear tinnitus after acute acoustic trauma , idiopathic sudden sensorineural hearing loss ( ISSNHL ) , or acute otitis media .


Prospective , double-blind , randomized , placebo-controlled study with follow-up visits on Days @ , @ , and @ .


Twenty-eight European sites ( academic tertiary referral centers and private ENT practices ) .


@ patients aged @ to @ years .


Three intratympanic injections of AM-@ ( @ or @ mg/ml ) or placebo over @ consecutive days .


Efficacy was assessed by changes in minimum masking level ( MML ; primary end point ) , loudness match , tinnitus loudness , tinnitus annoyance , and sleep difficulties on a @ to @ numerical rating scale , THI-@ questionnaire , and patient global impression of change .


Safety was evaluated using the frequency of clinically relevant hearing deterioration and adverse events .


The study overall failed to demonstrate a treatment benefit based on the change in MML .


However , AM-@ @ mg/ml showed statistically significantly better improvement for tinnitus loudness , annoyance , sleep difficulties , and tinnitus impact in patients with tinnitus after noise trauma or otitis media .


The subgroup of ISSNHL-related tinnitus patients did not show conclusive results .


The study drug and I.T. injections were well tolerated .


The study established proof of concept for AM-@ in the treatment of tinnitus arising from cochlear glutamate excitotoxicity .


Patient-reported outcomes seem to be more relevant and reliable efficacy measures for assessing treatment-related changes in tinnitus than psychoacoustic tests .


To explore the effect of vitamin A ( VA ) combined iron supplements on iron metabolic homeostasis for preschoolers .


About @ preschoolers with aged @-@ years old from eight kindergartens in Pixian county , Chengdu were recruited into this trial from March to September , @ .


All subjects met the inclusion criteria were randomly divided into four groups using random number table : sole VA supplementation group ( VA group , a single oral dose of VA at about @ @ units ) , sole iron supplementation group ( FE group , daily oral supplementation with the element iron @-@ mgkg ( -@ ) d ( -@ ) for five days a week , lasting for @ months ) , the combined supplementation of VA and iron group ( VF group ) and control group ( CO group , no VA and iron supplementation ) .


The concentration of serum VA , serum ferritin ( SF ) , serum transferring receptor ( sTfR ) , C-reactive protein ( CRP ) and hemoglobin ( Hb ) were measured from @ ml vein blood .


The sTfR-SF index ( TFR-F index ) and total body iron content ( TBIC ) before and after intervention were calculated .


The differences of these indexes between groups before and after intervention were analyzed .


The level of sTfR before intervention in VA group ( ( @ @ ) mg/L ) was significantly higher than that of after intervention ( ( @ @ ) mg/L ) ( t = @ , P < @ ) .


The levels of TFR-F index and TBIC in FE and VF groups before intervention ( ( @ @ ) , ( @ @ ) and ( @ @ ) , ( @ @ ) mg/kg , respectively ) were all lower than those of after intervention ( TFR-F index : ( @ @ ) , ( @ @ ) and TBIC : ( @ @ ) , ( @ @ ) mg/kg ) ( t values were @ , @ , @ and @ , respectively , all P values were < @ ) .


The incidence of iron deficiency in VA , FE , and VF groups before intervention were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) and were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) for after intervention , respectively .


The difference of this index in VA , FE and VF groups were significant ( ( @ ) values were @ , @ and @ , respectively , all the P values were < @ ) .


Combined VA and iron was as effective as VA alone or iron alone in decreasing the iron deficiency , the impact of VA intervention on iron metabolic homeostasis was mainly manifested in iron usage and mobilization , but showed no effect on total body iron content .


To examine the effects of two factors on the transmission of clinical information at nursing handover .


These factors were : ( i ) an affective statement expressing concern about the information ; and ( ii ) verbal reference to a written summary of the information .


Quality of communication at patient handover is inconsistent , compromising patient safety .


Little is known about the nuances of communication that lead to effective handovers .


Furthermore , effective information transmission during handovers is seldom evaluated using experimental research designs .


A randomized , single-blind , controlled experiment .


Postanaesthesia care unit or surgical ward nurses and final-year nursing students were randomly assigned to watch one of four versions of a video-recorded handover .


In each version , one piece of information was presented as either a simple statement ( control ) , with an affective qualifier , with a written summary of the information , or with both an affective qualifier and a written summary .


Primary outcome was assessed by questionnaire following a task directing attention away from the handover .


Data were collected July-October , @ and analysed using @ anova .


A total of @ nurses participated .


Successful transmission of the clinical information did not significantly differ across the experimental conditions .


Subgroup analysis revealed significantly higher transmission success among more experienced nurses when the affective statement was present compared to when it was absent ( Kruskal-Wallis P = @ ) .


Expressing concern about information or directing attention to written notes may not improve information transfer at handover .


However , affective qualifiers may have differential receiver-specific influences on information retention .


Ultrasound guidance is still a young method in regional anesthesia when compared to nerve stimulation and only a few studies exist comparing these two techniques in an axillary multiple injection approach .


This prospective , randomized , observer-blinded study compared an ultrasound-guided ( SONO ) quadruple injection axillary block ( out of plane , perineural ) with a nerve stimulation-guided ( STIM ) triple injection axillary block for upper limb surgery .


A total of @ patients were randomized to either the SONO ( n = @ ) or STIM ( n = @ ) group .


For the block @-@ml mepivacaine @ % ( plexus ) and @-@ml mepivacaine @ % ( subcutaneous in the medial skin of the arm ) was used .


Anesthesia time was recorded as the primary end point .


After evaluation of block-related pain using a visual analog scale ( VAS ) a blinded observer tested sensory and motor function of the median nerve ( MED ) , ulnar nerve ( ULN ) , radial nerve ( RAD ) , musculocutaneous nerve of the upper limb ( MUC ) and medial cutaneous nerve of the forearm ( CAM ) at defined times .


The main outcome variable was onset time ( defined loss of sensory/motor function ) .


No differences were observed between the groups in terms of onset time ( single nerves @-@min , plexus @-@min ) and success rate ( SONO @ % , STIM @ % ) .


Patient satisfaction as measured by block-related pain score ( VAS @cm ) , complications ( vascular puncture SONO @ % , STIM @ % ; paresthesia SONO @ % , STIM @ % ) and patient acceptance ( SONO @ % , STIM @ % ) showed no differences .


Performance time was shorter in the SONO group ( @ min vs. @ , p = @ ) .


Nerve stimulation-guided axillary plexus blocks performed by trained anesthesiologists may result in similar onset times and success rates compared to ultrasound-guided blocks .


Multidisciplinary , age-related , structured , group educational programmes for children with atopic dermatitis ( AD ) and their parents have shown positive long-term outcomes with respect to quality of life and coping behaviour of the participants .


We aimed to identify predictors of favourable long-term outcome of an education measure for parents of children with AD aged @months to @years in the framework of The German Atopic Dermatitis Intervention Study ( GADIS ) .


In an exploratory approach , the data of @ child-parent pairs were analysed with respect to the influence of various somatic and psychological variables as possible predictors of treatment success .


Changes in parents ' QoL , SCORAD ( Scoring Atopic Dermatitis ) , topical corticosteroid use and parents ' knowledge about AD between baseline and @-months ' follow-up were chosen as measures of long-term treatment success ( outcome ) .


Psychological rather than somatic parameters were identified as predictors of treatment success .


Parents who had negative treatment experiences in the past and possessed only poor coping abilities with regard to scratch control benefitted the most from the training programme .


The outcome of the education measure was independent of parents ' schooling , vocational level and income .


Parents of children with AD who lack adequate coping abilities should be particularly encouraged to take part in such an education programme .


Surgical site infections ( SSI ) after vascular surgery are related to substantial morbidity .


Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept .


We performed a randomized clinical trial to assess the effect of the sealing of skin with a cyanoacrylate preparation at the site of surgery on the incidence of SSI after arterial reconstruction .


Patients scheduled for vascular reconstruction in or distal to the groin were randomized into a treatment and a control group .


Standard measures for preventing contamination of the surgical field were taken in the control group , whereas cyanoacrylate was used as a skin sealant at the surgical site in the patients in the treatment group .


We hypothesized that the incidence of SSI with the use of cyanoacrylate would be two-thirds ( @ % ) lower than that with standard preparation of the surgical site , and performed an interim analysis of @ patients to assess this .


Risk factors among the @ patients in the study included smoking ( @ % ) , hypertension ( @ % ) , diabetes mellitus ( @ % ) , and hypercholesterolemia ( @ % ) .


Indications for surgery were invalidating claudication ( Fontaine IIb ) , pain at rest , or tissue necrosis .


The overall incidence of SSI was @/@ ( @ % ) , without differences between groups ; @ % SSIs in the control group versus @ % SSIs in the intervention group .


We could not confirm a reduction in the incidence of SSI after inguinal vascular surgery with the use of a cyanoacrylate skin sealant as compared with conventional means for preparing the surgical site .


Thromboelastometric evaluation of coagulation might be useful for prediction and management of bleeding after paediatric cardiac surgery .


We tested the hypothesis that the use of a thromboelastometry-guided algorithm for blood product management reduces blood loss and transfusion requirements .


We studied @ patients undergoing paediatric cardiac surgery with cardiopulmonary bypass ( CPB ) for the initial @ h after operation .


Stepwise multiple linear regression was used to develop an algorithm to guide blood product transfusions .


Thereafter , we randomly assigned @ patients to conventional or algorithm-guided blood product management , and assessed bleeding and red cell transfusion requirements .


CPB time , post-bypass rotational thromboelastometry ( ROTEM ( ) ) EXTEM amplitude at @ min ( A@ ) , and FIBTEM-A@ were independently associated with chest tube drainage volume during the initial @ h after operation .


Discriminative analysis determined cut-off values of @ mm for EXTEM-A@ and @ mm for FIBTEM-A@ , and estimated optimal intraoperative fresh-frozen plasma and platelet concentrate transfusion volumes .


Thromboelastometry-guided post-bypass blood product management significantly reduced postoperative bleeding ( @ vs @ ml kg ( -@ ) , P < @ ) and packed red cell transfusion requirement ( @ vs @ ml kg ( -@ ) , P = @ ) at @ h after surgery , and duration of critical care stay ( @ vs @ h , P = @ ) .


Rotational thromboelastometry-guided early haemostatic intervention by rapid intraoperative correction of EXTEM-A@ and FIBTEM-A@ reduced blood loss and red cell transfusion requirements after CPB , and reduced critical care duration in paediatric cardiac surgical patients .


The goal of this study was to assess the safety and tolerability of omecamtiv mecarbil treatment during symptom-limited exercise in patients with ischemic cardiomyopathy and angina .


These patients may have increased vulnerability to prolongation of the systolic ejection time .


Omecamtiv mecarbil is a selective cardiac myosin activator that augments cardiac contractility in patients with systolic heart failure through a dose-dependent increase in systolic ejection time .


In this double-blind , placebo-controlled study , patients with chronic heart failure were randomized @:@ to receive omecamtiv mecarbil or placebo in @ sequential cohorts of escalating doses designed to achieve plasma concentrations previously shown to increase systolic function .


Patients underwent @ symptom-limited exercise treadmill tests ( ETTs ) at baseline ( ETT@ and ETT@ ) and again before the end of a @-h infusion of omecamtiv mecarbil ( ETT@ ) .


The primary pre-defined safety endpoint ( i.e. , the proportion of patients who stopped ETT@ because of angina at a stage earlier than baseline ) was observed in @ patient receiving placebo and none receiving omecamtiv mecarbil .


No dose-dependent differences emerged in the proportion of patients stopping ETT@ for any reason or in the pattern of adverse events .


Doses of omecamtiv mecarbil producing plasma concentrations previously shown to increase systolic function were well tolerated during exercise in these study patients with ischemic cardiomyopathy and angina .


There was no indication that treatment increased the likelihood of myocardial ischemia in this high-risk population .


( Pharmacokinetics -LSB- PK -RSB- and Tolerability of Intravenous -LSB- IV -RSB- and Oral CK-@ in Patients With Ischemic Cardiomyopathy and Angina ; NCT@ ) .


There is currently a trend toward minimally invasive total knee arthroplasty ( TKA ) to decrease the morbidity related to the standard approach .


The aim of our study was to clarify whether the mini-subvastus surgical had an advantage over the standard in term of pain level , blood loss , and postoperative recovery , whether the mini-subvastus surgical was prone to radiographic malalignment , prolonged operative time , and increased complications .


In a prospective randomized study , we compared the clinical and radiological results of primary TKA using a mini-subvastus approach or a standard approach in @ patients .


The mini-subvastus approach was used on @ patients ( group I ) and the standard approach on @ patients ( group II ) .


The mean follow-up was @ months ( range @-@ months ) .


Patients in group I had less blood loss and better visual analogue scale score at @ day postoperatively .


They achieved active straight leg raise earlier and underwent less lateral retinacular releases .


The mean Knee Society function score , Oxford knee score , and range of movement were significantly better in group I up to @ months after surgery ( all , p < @ ) .


However , there were no significant differences in these parameters between the groups at final follow-up .


Reduced access and visibility in group I prolonged tourniquet time by an average of @ min and resulted in five technical errors on radiographic evaluation .


Patients can receive marked but temporary benefits from the mini-subvastus technique , with a definite cost : that of component malposition and prolongation of operative time .


Ivabradine ( IVA ) , a selective If current inhibitor decreasing the heart rate ( HR ) in patients with sinus rhythm , has been added to the most recent European Guidelines on heart failure .


This selective treatment reduces HR exclusively while fully preserving myocardial contractility and relaxation , atrioventricular conduction , and ventricular repolarization , as well as blood pressure .


The aim of this study was to evaluate the improvement of quality of life ( QOL ) in patients with chronic heart failure ( CHF ) treated with IVA versus two - blockers ( bisoprolol and carvedilol ) .


We evaluated if a @-month treatment with IVA ( @ mg b.i.d. ) or - blockers ( carvedilol @ mg b.i.d. or bisoprolol @ mg b.i.d. ) improves the QOL ( assessed by SF-@ questionnaire ) in patients with CHF with reduced left ventricular ejection fraction ( < @ % ) .


SF-@ was tested in @ CHF patients ( mean age @ @ years ) randomized into two groups ( IVA group - @ patients ; - blockers group - @ patients ) .


Data of QOL questionnaire and HR were collected by an interview during a clinical visit both at prescription time ( basal ) and after @ month of therapy with IVA or - blockers .


QOL life and HR results after @-month of therapy ( T@ ) with IVA were compared with basal values ( T@ ) .


The IVA versus - blockers treatment was associated with a significant improvement of physical functioning ( p < @ vs. p < @ ) , physical role functioning ( p < @ vs. p < @ ) , emotional role functioning ( p < @ vs. p < @ ) , and mental health scales ( p < @ vs. p < @ ) .


HR in the IVA group was significantly lower compared to the group of patients treated with - blockers ( @ vs. @ bpm ; p < @ ) .


IVA treatment significantly improves the QOL in patients with CHF without any deleterious impact on hemodynamics , and may be beneficial in these patients without other adverse effects associated with - blockers .


Lyme borreliosis , a potentially severe tick-borne infection caused by Borrelia burgdorferi , can cause multi-system inflammatory disease .


The incidence has been increasing , as has the number of patients with persistent symptoms attributed to Borrelia .


These symptoms , also referred to as post-Lyme disease syndrome , may follow an erythema migrans or other Lyme manifestations , and include pain , fatigue , and cognitive disturbances .


The optimal duration of treatment for these symptoms is a subject of controversy .


The PLEASE study is designed to determine whether prolonged antibiotic treatment leads to better patient outcome than standard treatment .


The PLEASE study is a double-blind , randomized , placebo-controlled trial .


Based on power analysis and compensating for possible loss to follow-up , a minimum of @ patients with borreliosis-attributed persistent symptoms are included .


These symptoms are either ( a ) temporally related to an erythema migrans or otherwise proven symptomatic borreliosis , or ( b ) accompanied by a positive B. burgdorferi IgG or IgM immunoblot .


All patients receive open-label ceftriaxone for two weeks .


Patients are then randomized ( ratio @:@:@ ) to blinded oral follow-up treatment for @ weeks with ( I ) doxycycline , ( II ) clarithromycin combined with hydroxychloroquine , or ( III ) placebo .


The primary outcome is the physical component summary score ( PCS ) of the RAND-@ Health Status Inventory ( RAND SF-@ ) at week @ .


Secondary outcomes include physical and mental aspects of health-related quality of life ( assessed by the subscales of the RAND SF-@ ) , fatigue , neuropsychological evaluation , physical activity , and cost-effectiveness .


This article describes the background and design issues of the PLEASE study protocol .


The results of this study may provide evidence for prescribing or withholding prolonged antibiotic treatment .


Contact force ( CF ) monitoring could be useful in accomplishing circumferential pulmonary vein ( PV ) isolation ( CPVI ) for atrial fibrillation ( AF ) .


The purpose of this study was to compare procedure parameters and outcomes between CF-guided and non-guided CPVI .


Thirty-eight consecutive AF patients ( mean age @ @ years , @ paroxysmal AF ) undergoing CPVI were randomized to non-CF-guided ( n = @ ) and CF-guided ( n = @ ) groups .


CPVI was performed with the ThermoCool SmartTouch catheter in both groups .


The end-point was bidirectional block between the left atrium ( LA ) and PV .


In the CF group , CF was kept between @ and @ g during CPVI , whereas in the non-CF group , all CF information was blanked .


Radiofrequency energy at @ W in the anterior and @ W in the posterior LA wall was applied for @-@ seconds at each point .


CPVI was successfully accomplished without any major complications in both groups .


Mean CF in the non-CF and CF groups were @ @ g and @ @ g , respectively , for left-side CPVI , and @ @ g and @ @ g , respectively , for right-side CPVI ( both P < @ ) .


The procedure and fluoroscopy times for CPVI in the non-CF and CF groups were @ @ minutes and @ @ minutes , respectively ( P < @ ) , and @ @ seconds and @ @ seconds ( P = NS ) , respectively .


Total number of residual conduction gaps was @ @ in the non-CF group and @ @ in the CF group ( P < @ ) .


During @-month follow-up , @ % of patients in the non-CF group and @ % in the CF group were free from any atrial tachyarrhythmias ( P = @ ) .


CF-guided CPVI is effective in reducing procedure time and additional touch-up ablation and may improve long-term outcome .


To measure neurodevelopment at @ years of age in children with single right-ventricle anomalies and to assess its relationship to Norwood shunt type , neurodevelopment at @ months of age , and patient and medical factors .


All subjects in the Single Ventricle Reconstruction Trial who were alive without cardiac transplant were eligible for inclusion .


The Ages and Stages Questionnaire ( ASQ , n = @ ) and other measures of behavior and quality of life were completed at age @ years .


Medical history , including measures of growth , feeding , and complications , was assessed through annual review of the records and phone interviews .


The Bayley Scales of Infant Development , Second Edition ( BSID-II ) scores from age @ months were also evaluated as predictors .


Scores on each ASQ domain were significantly lower than normal ( P < @ ) .


ASQ domain scores at @ years of age varied nonlinearly with @-month BSID-II .


More complications , abnormal growth , and evidence of feeding , vision , or hearing problems were independently associated with lower ASQ scores , although models explained < @ % of variation .


Type of shunt was not associated with any ASQ domain score or with behavior or quality-of-life measures .


Children with single right-ventricle anomalies have impaired neurodevelopment at @ years of age .


Lower ASQ scores are associated with medical morbidity , and lower BSID-II scores but not with shunt type .


Because only a modest percentage of variation in @-year neurodevelopmental outcome could be predicted from early measures , however , all children with single right-ventricle anomalies should be followed longitudinally to improve recognition of delays .


Community-acquired pneumonia ( CAP ) is a common infectious disease throughout the world and the incidence continues to grow as the population ages .


Aspiration is an important pathogenic mechanism for pneumonia in the elderly and the management of patients with community-acquired pneumonia with aspiration factors is a major medical problem .


Our study aimed to assess whether moxifloxacin in comparison to levofloxacin plus metronidazole are effective and safe in the treatment of community-acquired pneumonia with aspiration factors .


In this prospective , multicenter , open-label , randomized controlled trial , @ patients with mild-to-moderate community-acquired pneumonia with aspiration factors were enrolled and randomly assigned to receive moxifloxacin or levofloxacin plus metronidazole .


The primary efficacy variables were clinical outcomes in evaluable patients at a follow-up visit @ to @ days after the end of therapy .


Seven days after the end of therapy a clinical cure was achieved for @ % ( @ of @ ) of efficacy-evaluable patients in the moxifloxacin group and @ % ( @ of @ ) of patients in the levofloxacin plus metronidazole group .


There was a significant difference between the two groups ( ( @ ) = @ , P < @ ) .


Bacteriological success rates were similar in the moxifloxacin group ( @ % ) and levofloxacin plus metronidazole group ( @ % ) , there was no significant difference between the two groups ( P > @ ) .


The overall adverse event rate was @ % ( @/@ ) in the moxifloxacin group versus @ % ( @/@ ) in the levofloxacin plus metronidazole group , there was no significant difference between the two groups ( P > @ ) .


No serious adverse events were observed .


Moxifloxacin is effective and safe for treatment of community-acquired pneumonia with aspiration factors .


And the regimen of moxifloxacin monotherapy is more convenient compared with levofloxacin plus metronidazole .


Premature infants respond more intensively to pain compared with term infants .


Facilitated tucking position as a non-pharmacological method of pain in infants has been suggested ; however , its effect on acute procedural pain such as endotracheal suctioning remains to be studied .


This study examined the effect of facilitated tucking position during suctioning on physiological responses and coping with stress in premature infants .


This was a randomized controlled crossover study .


Thirty-four premature infants received an order of either suctioning with intervention - suctioning without intervention , or suctioning without intervention - suctioning with intervention .


Neonatal Infant Pain Scale ( NIPS ) was used to collect the data .


No statistical significant difference was seen between intervention and non-intervention cases in terms of the average time duration to reach the pain score to one or zero , and also , in the average of changes in oxygen saturation .


However , changes in heart rate were less in intervention cases .


The effect of facilitated tucking position on coping with stress was not found in this study .


This non-pharmacological strategy can be suggested because of its effect on reducing changes in heart rate during painful procedure .


It is suggested to replicate the study with larger number of samples .


To evaluate intravitreal aflibercept @ mg in patients with myopic choroidal neovascularization ( CNV ) .


An international , phase III , multicenter , randomized , double-masked , sham-controlled study .


Patients aged @ years with high myopia ( -@ diopters or axial length of @ mm ) , active myopic CNV , and best-corrected visual acuity ( BCVA ) of @-@ Early Treatment Diabetic Retinopathy Study letters in the study eye were included .


Patients were randomized @:@ to intravitreal aflibercept or sham .


In the intravitreal aflibercept arm , patients received @ injection at baseline .


Additional injections were performed in case of CNV persistence or recurrence at monthly visits through week @ .


In the sham arm , patients received sham injections through week @ .


At week @ , after assessment of the primary efficacy end point , sham patients received a mandatory intravitreal aflibercept injection followed by intravitreal aflibercept ( if disease persisted/recurred ) or sham injection every @ weeks .


Mean change in BCVA from baseline to week @ .


A total of @ patients were randomized to intravitreal aflibercept ( n = @ ) or sham ( n = @ ) .


Baseline demographics were similar across groups .


At week @ , patients in the intravitreal aflibercept and sham groups gained @ and lost @ letters , respectively ( P < @ ) .


By week @ , patients in the intravitreal aflibercept and sham/intravitreal aflibercept groups gained @ and @ letters .


Patients in the intravitreal aflibercept group received @ injections ( median ) in the first study quarter ( week @-@ ) .


Median number of injections in quarters @ to @ was @ .


Patients in the `` sham/intravitreal aflibercept '' group received @ and @ ( median ) intravitreal aflibercept injections in quarters @ and @ .


Central retinal thickness improved in parallel with visual gains .


Incidence of ocular adverse events was similar in both groups through week @ ( @ % vs. @ ) ; most were assessed by investigators as mild .


No deaths occurred .


Intravitreal aflibercept @ mg was effective for treatment of myopic CNV with clinically important visual and anatomic benefits achieved with a limited number of injections given in the first @ weeks of treatment .


No new safety concerns occurred with treatment .


Intravitreal aflibercept should be considered as a treatment option for myopic CNV .


The aim of this study was to compare the pain perception and side effects during and after endovenous laser ablation with a @ nm diode laser using cold or room temperature tumescence anesthesia .


One hundred and one patients were randomly assigned in two groups .


Group A received room temperature ( +@ ) and Group B received cold ( +@ ) tumescence fluid , which was used for local anesthesia in the track of great saphenous vein .


A visual analog score was recorded immediately after the procedure .


Patients were asked to register pain scores and the amount of pain medication consumed during the week .


There was no significant difference concerning gender , age , Clinical Etiological Anatomical Pathological Classification , body mass index , or diameter of the treated vein .


In Group A , the mean linear endovenous energy density was @ J/cm and in Group B , it was @ J/cm .


The average visual analog score after the endovenous laser ablation procedure in Group A was @ and in Group B was @ .


Third day after the procedure , the average visual analog score in Group A was @ and in Group B was @ .


Patients in Group B needed significantly less analgesics compared with patients in Group A ( p < @ ) .


The most frequent side effects in both groups were ecchymosis , induration , and minor paraesthesia , all of which were more common in Group A ( p < @ ) .


To date , most published endovenous laser ablation series describe the use of room temperature tumescence fluid infiltration of the perivenous stroma for tumescent analgesia and protection against thermal injury to the nearby structures .


We describe an alternative technique using cold tumescence fluid infiltration , which is equally effective as , but safer than , room temperature tumescence fluid infiltration , and which yields better visual analog scores .


Although several studies have compared a conventional transtibial technique with an anteromedial ( AM ) portal technique for single-bundle ( SB ) anterior cruciate ligament ( ACL ) reconstruction , no study to date has investigated whether the modified transtibial technique results in the femoral tunnel being in a similar anatomic position and produces similar clinical outcomes with those of the AM portal technique .


To compare the clinical outcomes and femoral tunnel position of SB ACL reconstruction using a modified transtibial technique ( creating a femoral tunnel with varus and internal rotation of the tibia as well as modification of the tibial tunnel orientation ) with those of SB ACL reconstruction using an AM portal technique .


Randomized controlled trial ; Level of evidence , @ .


A total of @ patients ( @ knees ) who underwent arthroscopic SB ACL reconstruction were included in this study .


Patients were randomized using a computer-generated sequence into @ groups : @ patients by the modified transtibial technique ( group @ ) and @ patients by the AM portal technique ( group @ ) .


Clinical evaluations included the @ International Knee Documentation Committee ( IKDC ) subjective knee score , Lysholm knee score , Tegner activity scale , Lachman test , pivot-shift test , @ IKDC knee examination , and KT-@ arthrometer measurement .


Three-dimensional computed tomography scans were analyzed according to the quadrant method , and the obliquity of the femoral tunnels in the coronal and sagittal planes and the size of the tunnel orifice were measured .


All clinical parameters improved significantly after SB ACL reconstruction , with no between-group differences .


The mean distance of the femoral tunnel center location from the posterior condylar surface ( @ % difference ; P = @ ) and from the Blumensaat line ( @ % difference ; P = @ ) was similar in groups @ and @ .


The mean coronal obliquity of the femoral tunnel was significantly lower in group @ than in group @ ( @ @ vs @ @ , respectively ; P = @ ) , but the mean sagittal obliquity was similar between the @ groups ( @ @ vs @ @ , respectively ; P = @ ) .


The mean area of the tunnel orifice was significantly greater in group @ than in group @ ( @ @ @ @ mm vs @ @ @ @ mm , respectively ; P = @ ) .


The modified transtibial technique for SB ACL reconstruction showed good clinical results and anatomic placement of the femoral tunnel , similar with those of the AM portal technique .


Vernal keratoconjunctivitis ( VKC ) is a chronic , bilateral inflammation of the conjunctiva that mostly affects children and young adult males .


Management of VKC is primarily aimed at reducing symptoms and preventing serious vision threatening sequelae .


To assess the efficacy of topical cyclosporine A ( CsA ) @ % on the signs and symtomps in the management of VKC .


This is a placebo-controlled , randomized prospective study .


Sixty-two patients with VKC were included in this study .


Patients were randomly assigned ( @ : @ ) to treatment with topical @ % CsA eyedrops or a placebo ( artificial tears ) for a period of @ weeks , @ times daily .


Ocular signs and symptoms were in all patients scored at entry and at the end of @ weeks .


When pre-treatment mean signs and symptoms scores were compared in both groups , there was no significant difference ( p > @ ) .


However , mean post-treatment scores as regards signs and symptoms were found to be lower in cyclosporine group than those in placebo group ( p < @ ) .


No side effects of the treatment with CsA @ % eyedrops were observed .


It was found that topical CsA @ % eyedrops were safe and effective in the treatment of patients with VKC .


There is minimal information on the impact of replacing sugar-sweetened beverage ( SSB ) consumption with water on diet quality from randomized controlled trials .


We evaluated the effect of a water intake intervention on diet quality in overweight Mexican women .


Women with a body mass index @ and < @ , @-@ y old , and a self-reported high intake of SSBs ( @ kcal/d ) were randomly allocated to either the water and education provision ( WEP ) group ( n = @ ) or the education provision ( EP ) only group ( n = @ ) .


Each group received monthly nutrition counseling , and the WEP group received biweekly water deliveries for @ mo. .


Three @-h recalls , anthropometry , and demographic information were collected at baseline , and @ , @ , and @ mo. .


Energy , macronutrient , sugar , SSB , fruit and vegetable , salty snack , cake and cookie , and fast food intakes were assessed in study completers ( n = @ ) classified by intervention assignment and by actual water intake at every time point ( low < @ vs. high @ mL/d ) .


The WEP group reported greater decreases in SSB intake than the EP group ( from @ % to @ % of energy/d vs. from @ % to @ % ) .


Thirty-eight percent of the EP group and @ % of the WEP group reported attaining a water intake @ mL/d .


Reductions in energy intake and food groups were similar across intervention groups .


However , the high actual water intake group reported greater increases vs. the lower intake group in intake of fruits and vegetables ( @ vs. @ g/d ) , as well as larger reductions in salty snacks ( @ vs. @ g/d ) and cakes and cookies ( @ vs. @ g/d ) .


Other than SSBs , improvements in food group intake did not differ by intervention group in overweight Mexican women .


However , post hoc analyses suggested that achieving a high actual water intake was associated with additional beneficial changes in food group intake .


This trial was registered at clinicaltrials.gov as NCT@ .


This study aims to describe the process of conducting a randomized clinical trial of elderly with chronic dizziness subjected to vestibular rehabilitation ( VR ) and to verify its effectiveness on dizziness intensity .


Older adults ( @ years ) with chronic dizziness from vestibular disorders referred to VR were enrolled to the trial .


The control group ( n = @ ) was submitted to the Cawthorne & Cooksey protocol and the experimental group ( n = @ ) to the modified Cawthorne & Cooksey protocol which included multiple components .


Protocols were performed during individual @-minute sessions , twice-weekly , for eight weeks .


Main measures were : recruitment data ( refusal and eligibility ) , baseline characteristics , dropout rate , session attendance , protocol adherence , adverse effects , exercise adaptation and follow-up events .


The Visual Analog Scale ( VAS ) was used to measure dizziness intensity .


@ elderly were referred to VR , @ % declined to participate and @ % were ineligible .


There were @ session non-attendances , with disease being the most frequent reason .


Regardless of VR protocol , VAS dizziness intensity diminished along sessions ( p < @ ) .


@ % of the participants reported improvement after treatment , and @ % mentioned an increase in dizziness on follow-up .


Home exercises were no longer being performed by @ % of the subjects after @ months from discharge .


The final dropout rate was @ % .


There were no differences between VR protocols on recruitment , dropout , session 's attendance , adherence to protocol and treatment effects .


Our results revealed many challenges in conducting a rehabilitation trial with an elderly sample .


The VR protocols showed to be feasible and suitable to reduce dizziness in older adults .


Mental practice , the cognitive rehearsal of a task without physical movement , is known to enhance performance in sports and music .


Investigation of this technique in surgery has been limited to basic operations .


The purpose of this study was to develop mental practice scripts , and to assess their effect on advanced laparoscopic skills and surgeon stress levels in a crisis scenario .


Twenty senior surgical trainees were randomized to either conventional training or mental practice groups , the latter being trained by an expert performance psychologist .


Participants ' skills were assessed while performing a porcine laparoscopic jejunojejunostomy as part of a crisis scenario in a simulated operating room , using the Objective Structured Assessment of Technical Skill ( OSATS ) and bariatric OSATS ( BOSATS ) instruments .


Objective and subjective stress parameters were measured , as well as non-technical skills using the Non-Technical Skills for Surgeons rating tool .


An improvement in OSATS ( P = @ ) and BOSATS ( P = @ ) scores was seen in the mental practice group compared with the conventional training group .


Seven of ten trainees improved their technical performance during the crisis scenario , whereas four of the ten conventionally trained participants deteriorated .


Mental imagery ability improved significantly following mental practice training ( P = @ ) , but not in the conventional group ( P = @ ) .


No differences in objective or subjective stress levels or non-technical skills were evident .


Mental practice improves technical performance for advanced laparoscopic tasks in the simulated operating room , and allows trainees to maintain or improve their performance despite added stress .


To determine the safety and tolerability of @ doses of intranasal oxytocin ( Syntocinon ; Novartis , Bern , Switzerland ) administered to patients with frontotemporal dementia ( FTD ) .


We conducted a randomized , parallel-group , double-blind , placebo-controlled study using a dose-escalation design to test @ clinically feasible doses of intranasal oxytocin ( @ , @ , or @ IU ) administered twice daily for @ week to @ patients with behavioral variant FTD or semantic dementia ( clinicaltrials.gov registration number NCT@ ) .


Primary outcome measures were safety and tolerability at each dose .


Secondary measures explored efficacy across the combined oxytocin vs placebo groups and examined potential dose-related effects .


All @ doses of intranasal oxytocin were safe and well tolerated .


A multicenter trial is warranted to determine the therapeutic efficacy of long-term intranasal oxytocin for behavioral symptoms in FTD .


This study provides Class I evidence that for patients with FTD , intranasal oxytocin is not significantly associated with adverse events or significant changes in the overall neuropsychiatric inventory .


There is a need for cost-effective weight management interventions that primary care can deliver to reduce the morbidity caused by obesity .


Automated web-based interventions might provide a solution , but evidence suggests that they may be ineffective without additional human support .


The main aim of this study was to carry out a feasibility trial of a web-based weight management intervention in primary care , comparing different levels of nurse support , to determine the optimal combination of web-based and personal support to be tested in a full trial .


This was an individually randomised four arm parallel non-blinded trial , recruiting obese patients in primary care .


Following online registration , patients were randomly allocated by the automated intervention to either usual care , the web-based intervention only , or the web-based intervention with either basic nurse support ( @ sessions in @months ) or regular nurse support ( @ sessions in @months ) .


The main outcome measure ( intended as the primary outcome for the main trial ) was weight loss in kg at @months .


As this was a feasibility trial no statistical analyses were carried out , but we present means , confidence intervals and effect sizes for weight loss in each group , uptake and retention , and completion of intervention components and outcome measures .


All randomised patients were included in the weight loss analyses ( using Last Observation Carried Forward ) .


At @months mean weight loss was : usual care group ( n = @ ) @ kg ; web-based only group ( n = @ ) @ kg ; basic nurse support group ( n = @ ) @ kg ; regular nurse support group ( n = @ ) @ kg .


Intervention effect sizes compared with usual care were : d = @ web-based ; d = @ basic nurse support ; d = @ regular nurse support .


Two practices deviated from protocol by providing considerable weight management support to their usual care patients .


This study demonstrated the feasibility of delivering a web-based weight management intervention supported by practice nurses in primary care , and suggests that the combination of the web-based intervention with basic nurse support could provide an effective solution to weight management support in a primary care context .


To determine the time-wise effect of specific resistance training on neck pain among industrial technicians with frequent neck pain symptoms .


Secondary analysis of a parallel-group cluster randomized controlled trial of @ weeks performed at two large industrial production units in Copenhagen , Denmark .


Women with neck pain > @ mm VAS ( N = @ ) were included in the present analysis .


The training group ( N = @ ) performed specific resistance training for the neck/shoulder muscles three times a week , and the control group ( N = @ ) received advice to stay active .


Participants of both groups registered neck pain intensity ( @-@ mm VAS ) once a week .


Neck pain intensity was @ mm ( SD @ ) at baseline .


There was a significant group by time interaction for neck pain ( F-value @ , P < @ , DF = @ ) .


Between-group differences in neck pain reached significance after @ weeks ( @ mm , @ % CI @ to @ ) .


The time-wise change in pain showed three phases ; a rapid decrease in the training group compared with the control group during the initial @ weeks , a slower decrease in pain during the following weeks ( week @-@ ) , and a plateau during the last weeks ( week @-@ ) .


Adherence to training followed a two-phase pattern , i.e. weekly participation rate was between @-@ % during the initial @ weeks , dropping towards @-@ % during the latter half of the training period .


Four weeks of specific resistance training reduced neck pain significantly , but @ weeks is required to achieve maximal pain reduction .


The time-wise change in pain followed a three-phase pattern with a rapid effect during the initial @ weeks followed by a slower but still positive effect , and finally a plateau from week @ and onwards .


Decreased participation rate may explain the decreased efficacy during the latter phase of the intervention .


The authors of this quasi-experimental design study explored the effect of an educational documentary video that presented factual and emotional aspects of stuttering on changing attitudes toward stuttering of preservice trainees and in-service public school teachers in Kuwait .


Participants were @ preservice trainees ( @ control , @ experimental ) and @ in-service teachers ( @ control , @ experimental ) .


All participants completed @ items from the Public Opinion Survey of Human Attributes-Stuttering ( POSHA-S ; St. Louis , @ ; translated into Arabic ) and @ additional items pre and post treatment .


Participants in the experimental group viewed the awareness video .


Pretreatment comparisons confirmed that the control and experimental groups did not differ on their attitudes toward stuttering .


As predicted , the posttreatment ratings for the control group were not different from the pretreatment ratings .


A significant shift in attitudes ( mostly in a positive direction ) from pre to post treatment was observed for the experimental group of preservice trainees but not for the experimental group of in-service teachers .


Interpretation of the difference in outcomes for the experimental preservice group as compared to the experimental in-service group is confounded by gender differences across groups .


The authors of this study demonstrated that it is possible to positively modify preservice trainees ' attitudes of people who stutter by using an educational documentary video .


We did a phase @ study in previous non-responders with chronic hepatitis C virus ( HCV ) genotype @ infection and compensated liver disease that related to the standard of care for these patients at the time this study was initiated .


We investigated whether simeprevir is non-inferior in terms of efficacy to telaprevir , each in combination with peginterferon alfa-@a and ribavirin .


We did this randomised , double-blind , phase @ trial at @ investigational sites in @ countries .


We enrolled adults ( @ years ) with chronic HCV genotype @ infection , compensated liver disease , and plasma HCV RNA higher than @ IU/mL who were null or partial responders during at least one previous course of peginterferon alfa-@a and ribavirin treatment .


We randomly assigned ( @:@ ) patients ( stratified by HCV genotype @ subtype -LSB- @a plus other/@b -RSB- and previous treatment response -LSB- partial or null -RSB- ) to receive simeprevir ( @ mg once a day ) plus telaprevir placebo ( three times a day @-@ h apart ) or telaprevir ( @ mg three times a day ) plus simeprevir placebo ( once a day ) in combination with peginterferon alfa-@a and ribavirin for @ weeks followed by @ weeks of peginterferon alfa-@a and ribavirin alone .


The primary efficacy endpoint was sustained virological response @ weeks after end of treatment ( SVR@ ) in the intention-to-treat and the per-protocol population .


We compared groups with the Cochran-Mantel-Haenszel test .


We established a non-inferiority margin of @ % .


Adverse events were reported descriptively .


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


Patient screening began on Jan @ , @ , and the last visit was on April @ , @ .


We included @ patients ( @ previous null responders -LSB- @ % -RSB- ) .


Simeprevir and peginterferon alfa-@a and ribavirin was non-inferior to telaprevir and peginterferon alfa-@a and ribavirin for SVR@ ( @ % -LSB- @/@ -RSB- vs @ % -LSB- @/@ -RSB- ; difference -@ % , @ % CI -@ to @ ; p = @ ) .


SVR@ was achieved in @ % ( @/@ ) versus @ % ( @/@ ) of previous partial responders and @ % ( @/@ ) versus @ % ( @/@ ) of previous null responders with simeprevir and peginterferon alfa-@a and ribavirin and telaprevir and peginterferon alfa-@a and ribavirin treatment , respectively .


We recorded differences between treatment groups in simeprevir or telaprevir-related adverse events ( @ % -LSB- @/@ -RSB- in the simeprevir group vs @ % -LSB- @/@ -RSB- in the telaprevir group ) , serious adverse events ( @ % -LSB- @/@ -RSB- vs @ % -LSB- @/@ -RSB- ) , and adverse events leading to simeprevir or telaprevir discontinuation ( @ % -LSB- @/@ -RSB- vs @ % -LSB- @/@ -RSB- ) .


Simeprevir once a day with peginterferon alfa-@a and ribavirin was well tolerated in HCV genotype @-infected previous non-responders and was non-inferior to telaprevir , thus providing an alternative treatment in areas of the world where all-oral HCV regimens are not available or accessible .


Chronic neck pain ( CNP ) is a common painful medical condition with a significant socioeconomic impact .