Compared with beclometasone-formoterol plus salbutamol as needed , beclometasone-formoterol for both maintenance and reliever treatment significantly increased the time to first exacerbation ( @ days vs @ days ) by @ days , with a @ % reduction in risk ( hazard ratio @ -LSB- @ % CI @ to @ -RSB- ; p = @ ) , and the estimated probability was @ % and @ % , respectively ( p = @ ) .


The number of days with mild asthma exacerbations was also lower with as-needed beclometasone-formoterol than with as-needed salbutamol ( @ days per patient per year vs @ days per patient per year ; @ -LSB- @ to @ -RSB- ; p = @ ) .


From the run-in period to week @ , both treatments improved symptoms ( mean change -@ -LSB- -@ to -@ -RSB- in the as-needed beclometasone-formoterol group vs -@ -LSB- -@ to -@ -RSB- in the as-needed salbutamol group , difference -@ -LSB- -@ to @ -RSB- ; p = @ ) , percentage of asthma control days ( @ % -LSB- @ to @ -RSB- vs @ % -LSB- @ to @ -RSB- , respectively , -@ -LSB- -@ to @ -RSB- ; p = @ ) , use of reliever ( -@ -LSB- -@ to -@ -RSB- vs -@ -LSB- -@ to -@ -RSB- , respectively , -@ -LSB- -@ to @ -RSB- ; p = @ ) , and lung function ( FEV@ , @ -LSB- @ to @ -RSB- vs @ -LSB- @-@ -RSB- , respectively , @ -LSB- -@ to @ -RSB- ; p = @ ) , and were well tolerated ( patients with serious adverse events , @ -LSB- @ % -RSB- and @ -LSB- @ % -RSB- , respectively ) .


Our results lend support to the use of the combination of a single inhaled corticosteroid plus a rapid-onset , long-acting @ agonist for maintenance and relief in patients with moderate to severe asthma and provide encouraging data for the formulation of beclometasone-formoterol for this use .


To compare the delivery and retention of triclosan in dental plaque , and to compare the antibacterial efficacy of a newly developed toothpaste to a marketed calcium carbonate toothpaste .


Two clinical delivery/retention studies were carried out to determine the concentration of triclosan in plaque @ minutes , and two and four hours after brushing with a new triclosan-containing toothpaste with magnesium aluminium silicate or a marketed triclosan-containing toothpaste .


Both studies had a double-blind , randomized , complete cross-over design .


Supragingival plaque samples ( minimum @ microg ) were taken from smooth surfaces of all teeth ( @-@ ) in all four quadrants for the @-minute plaque measurements and in two randomly allocated quadrants at the two - and four-hour time points .


Triclosan concentration was measured by HPLC .


Antibacterial efficacy was evaluated in vitro using a biofilm formation approach .


Three replicate experiments were carried out to check for repeatability and consistency of the assay .


Toothpaste slurries were prepared by stirring one part by weight of each toothpaste with two parts by weight of deionized water .


An overnight culture suspension of Streptococcus mutans ( ATCC @ ) was prepared and then adjusted to give a bacterial count of approximately @ ( @ ) CFU/ml .


Sterile HAP discs were used as substrate and treated with the toothpaste slurry before inoculation with the standardized culture suspension of S. mutans .


Following incubation in brain heart infusion ( BHI ) broth containing @ % sucrose for four hours , standard Total Viable Count ( TVC ) procedures were carried out and colonies counted ( log@ values ) .


Brushing with the new calcium carbonate/triclosan toothpaste resulted in a higher triclosan concentration in plaque after @ minutes , and two and four hours compared to a marketed triclosan toothpaste .


The increase ranged from @ % to @ % and was statistically significant ( p < @ ) .


The antibacterial efficacy of the new calcium carbonate/triclosan toothpaste , measured four hours after application , was greater than that of a marketed toothpaste with @ % triclosan .


The difference was statistically significant ( p < @ ) .


The new calcium carbonate toothpaste with @ % triclosan and magnesium aluminium silicate demonstrated significantly greater efficacy four hours post-brushing both in terms of in vivo delivery and in vitro antibacterial action compared to a marketed calcium carbonate toothpaste with @ % triclosan .


Children with congenital hemiparesis have unilateral upper extremity involvement , limiting their ability in unilateral or bilateral manual tasks , thus negatively influencing their participation in daily activities .


Constraint-induced movement therapy ( CIMT ) has been shown to be promising for improving upper-limb functions in children with cerebral palsy .


Clinical assessments may be needed to quantify and qualify changes in children 's performance following its application .


This study investigated the effectiveness of a child-friendly form of CIMT to improve upper extremity functional performance .


Thirty congenitally hemiparetic children aged @-@ years were randomly assigned to receive either a CIMT program ( study group ) or a conventional non-structured therapy program ( control group ) .


The programs were applied for both groups for six hours daily , five days weekly for four successive weeks .


The Pediatric Arm Function Test , Quality of Upper Extremity Skills Test , and isokinetic muscular performances of shoulder flexors , extensors , and abductors expressed as peak torque were used to evaluate immediate and long-lasting efficacy of CIMT .


The results showed improvement in the involved upper extremity performances in different evaluated tasks immediately post-CIMT program application compared with the control group .


These improvements continued three months later .


Pediatric CIMT with shaping produced considerable and sustained improvement in the involved upper extremity movements and functions in children with congenital hemiparesis .


While opioids provide effective analgesia , opioid-induced constipation ( OIC ) can severely impact quality of life and treatment compliance .


This pooled analysis evaluated the maintenance of efficacy and safety during long-term treatment with combined oxycodone/naloxone prolonged-release tablets ( OXN PR ) in adults with moderate-to-severe chronic pain .


Patients ( N = @ ) received open-label OXN PR during @-week extension phases of two studies , having completed @-week , double-blind , randomized treatment with oxycodone prolonged-release tablets ( Oxy PR ) or OXN PR .


Analgesia and bowel function were assessed at each study visit using ` Average pain over last @h scale and Bowel Function Index ( BFI ) , respectively .


Treatment Satisfaction Questionnaire for Medication was assessed at study end only .


Improvement in bowel function was particularly marked in patients who switched from Oxy PR in the double-blind phase to OXN PR during the extension phase , resulting in a clinically meaningful reduction ( @ points ) in BFI score : at the start of the extension phases , mean ( SD ) BFI score was @ ( @ ) , and was @ ( @ ) for patients who had received OXN PR in the double-blind phase .


One week later , BFI scores were similar for the two groups ( @ -LSB- @ -RSB- and @ -LSB- @ -RSB- , respectively ) , as was observed throughout the following months .


Fewer than @ % of patients received laxatives regularly .


Mean @-h pain scores were low and stable throughout the extension phases .


No unexpected adverse events were observed .


Pooled data demonstrate OXN PR is an effective long-term therapy for patients with chronic non-cancer pain , and can address symptoms of OIC .


No new safety issues were observed which were attributable to the long-term administration of OXN PR .


To assess pooled golimumab safety up to year @ of rheumatoid arthritis ( RA ) , psoriatic arthritis ( PsA ) and ankylosing spondylitis ( AS ) trials .


Golimumab @ and @ mg , administered subcutaneously ( SC ) every @ weeks ( q@wk ) , were assessed in patients with active RA ( methotrexate-nave , methotrexate-experienced and anti-TNF ( tumour necrosis factor ) - experienced ) , PsA or AS , despite conventional therapy .


Placebo control continued up to week ( wk ) @ ( wk @ , methotrexate-nave ) , with early escape at wk @ ( wk @ , methotrexate-nave ) ; subsequently , all patients received golimumab @ or @ mg q@wk .


After the blinded controlled period , golimumab doses could be adjusted per investigator discretion .


Pooled safety analyses reported herein include data from placebo-controlled and uncontrolled study periods up to wk @ .


Determinations of incidences/@ patient-years ( pt-yrs ) for rare events also included RA patients from a phase IIb trial .


Across five phase III trials of SC golimumab , @ patients received placebo and @ received golimumab @ mg ( n = @ ) and/or @ mg ( n = @ ) up to wk @ ( patients may be included in more than one group because non-responders were allowed early escape ) ; @ patients were treated for @ weeks .


For placebo , golimumab @ mg and golimumab @ mg , respective adverse event incidences/@ pt-yrs ( @ % CIs ) up to wk @ were : @ ( @ to @ ) , @ ( @ to @ ) , @ ( @ to @ ) for death ; @ ( @ to @ ) , @ ( @ to @ ) , @ ( @ to @ ) for serious infection ; @ ( @ to @ ) , @ ( @ to @ ) , @ ( @ to @ ) for tuberculosis ; @ ( @ to @ ) , @ ( @ to @ ) , @ ( @ to @ ) for opportunistic infection ; @ ( @ to @ ) , @ ( @ to @ ) , @ ( @ to @ ) for demyelination ; and @ ( @ to @ ) , @ ( @ to @ ) , @ ( @ to @ ) for lymphoma .


SC golimumab safety up to @ years remained consistent with that of other TNF antagonists .


Golimumab @ mg showed numerically higher incidences of serious infections , demyelinating events and lymphoma than @ mg ; safety follow-up up to year @ continues .


This study investigates the effect of aerobic interval training on diastolic function at rest and during exercise in stable heart transplant ( HTx ) recipients .


Twenty-three stable HTx recipients ( @ % males , mean age @ @ years ) were recruited to a training programme .


Intervention was @ weeks intensive training or control in a randomized controlled design .


At baseline , participants had normal or mild diastolic dysfunction at rest .


During exercise , mean E/e ' increased from @ ( @ ) to @ ( @ ) ( p = @ ) , E/A increased from @ ( @ ) to @ ( @ ) ( p = @ ) , and deceleration time decreased by over @ ms , all markers of increased filling pressure .


There were no correlations between diastolic function and VO @ peak at baseline .


After intervention VO @ peak increased from @ ( @ ) to @ ( @ ) ml/kg/min in the training group ( difference between groups p = @ ) .


No consistent pattern of improvement in diastolic function at rest or during exercise was seen .


The study does not support a role of diastolic dysfunction in the limited exercise capacity of HTx recipients and suggests that in these patients peripheral factors are of greater importance .


Pulmonary rehabilitation ( PR ) is a multidisciplinary program of care for patients with chronic obstructive pulmonary disease ( COPD ) with the goal of improving the functional capacity and quality of life , as well as maintaining the clinical stability of COPD sufferers .


However , not all patients are available for such a program despite discomfort with their condition .


The aim of this study was to evaluate the effects of a home-based PR ( HBPR ) program on functional ability , quality of life , and respiratory muscle strength and endurance .


Patients with COPD according to the Global Initiative of Chronic Obstructive Lung Disease were randomized ( double-blind ) into two groups .


One group performed a protocol at home with aerobic and muscle strength exercises and was called the intervention group ; the other group received only instructions to perform breathing and stretching exercises , characterizing it as the control group ( CG ) .


We assessed the following variables at baseline and @ months : exercise tolerance ( incremental shuttle walk test and upper limb test ) , respiratory muscle ( strength and endurance test ) , and health-related quality of life ( Airways Questionnaire @ ) .


There were no significant changes after the intervention in either of the two groups in exercise tolerance and quality of life .


However , the intervention group had improved respiratory endurance compared with the CG , while the CG presented a decrease in the load sustained by the respiratory muscles after the HBPR .


A program of HBPR with biweekly supervision ( although not enough to provide significant improvements in physical capacity or quality of life ) played an important role in maintaining the stability of the clinical features of patients with COPD ; the patients had no worsening of symptoms during the intervention period according to the daily log .


The pattern of atrial fibrillation ( AF ) occurrence-paroxysmal , persistent , or permanent-is associated with progressive stages of atrial dysfunction and structural changes and may therefore be associated with progressively higher stroke risk .


However , previous studies have not consistently shown AF pattern to predict stroke but have been hampered by methodological shortcomings of low power , variable event ascertainment , and variable anticoagulant use .


We analysed the rates of stroke and systemic embolism in @ aspirin-treated patients with AF from the ACTIVE-A/AVERROES databases .


There was thorough searching for events and adjudication .


Multivariable analyses were performed with the adjustment for known risk factors for stroke .


Mean age of patients with paroxysmal , persistent , and permanent AF was @ @ , @ @ , and @ @ years ( P < @ ) .


The CHA@DS@-VASc score was similar in patients with paroxysmal and persistent AF ( @ @ ) , but was higher in patients with permanent AF ( @ @ , P < @ ) .


Yearly ischaemic stroke rates were @ , @ , and @ % for paroxysmal , persistent , and permanent AF , respectively , with adjusted hazard ratio of @ ( P < @ ) for permanent vs. paroxysmal and @ ( P = @ ) for persistent vs. paroxysmal .


Multivariable analysis identified age @ year , sex , history of stroke or TIA , and AF pattern as independent predictors of stroke , with AF pattern being the second strongest predictor after prior stroke or TIA .


In a large population of non-anticoagulated AF patients , pattern of AF was a strong independent predictor of stroke risk and may be helpful to assess the risk/benefit for anticoagulant therapy , especially in lower risk patients .


In the process of behaviour change , intonation of speech is an important aspect that may influence persuasion when auditory messages are used .


In two experiments , we tested to what extent different levels of intonation are related to persuasion and whether for some recipients the threat posed by the message information might become too strong to face .


In Study @ , @ respondents listened to a health message with either a low , moderate or high level of intonation .


In Study @ ( N = @ ) , the same manipulations of intonation were applied but half of the respondents were affirmed before they listened to the persuasive message .


Intention to increase fruit and vegetable intake was used as a dependent variable .


Both studies showed that high intonation led to a significant drop in intention among respondents who perceived their own health as good .


After self-affirmation , persuasion was increased .


A high level of intonation seems to induce self-regulatory defences in people who do not see the necessity to change their health behaviour , whereas people with poor perceived health might perceive potential to change .


The use of a normal level of intonation in auditory health messages is recommended .


The aim of this randomized clinical trial was to evaluate the efficacy of a mouthrinse containing @ % potassium oxalate ( Listerine Advanced Defence Sensitive ; LADS ) plus Colgate Cavity Protection Regular toothpaste , in reducing dentin sensitivity .


This was an observer - and examiner-blinded , randomized , parallel-group , single-center , controlled , five-day clinical trial .


Healthy adults were randomized ( @:@:@ ) to LADS plus Colgate Cavity Protection Regular toothpaste , or to one of the two negative-control toothpastes alone : Crest Cavity Protection Regular or Colgate Cavity Protection Regular .


The subjects carried out supervised and unsupervised brushing and rinsing twice a day .


Dentin sensitivity was assessed at baseline and during treatment by Yeaple probe ( tactile pressure ; patient-reported discomfort by visual analogue scale -LSB- VAS -RSB- ) , as well as response to air blasts ( VAS ) .


All sensitivity assessments were similar at baseline in the @ randomized subjects .


By the third day , the Yeaple probe sensitivity scores for subjects treated with Colgate toothpaste plus LADS improved significantly compared to Crest toothpaste alone ( p < @ ) .


By the fifth day , the mean scores for subjects treated with Colgate toothpaste plus LADS were significantly improved compared with subjects treated with either toothpaste alone ( p < @ ) .


The other sensitivity assessments showed that Colgate toothpaste plus LADS achieved statistically significant improvements compared with Colgate and/or Crest toothpaste alone from the third day .


The @ % potassium oxalate mouthrinse ( LADS ) was associated with a reduction in dentinal sensitivity within a five-day period .


Statistically significant reductions in all sensitivity variables were achieved by Day @ and even greater reductions in dentin sensitivity scores were observed after five days .


The COPE-ICD ( Copenhagen Outpatient ProgrammE-implantable cardioverter defibrillator ) trial studied comprehensive cardiac rehabilitation for patients with ICDs .


The purpose of this paper was to explore : ( @ ) gender differences in self-rated health and quality of life ( QoL ) at hospital discharge after ICD implantation , ( @ ) gender differences in effect of cardiac rehabilitation , and ( @ ) predictors of effect of cardiac rehabilitation .


Patients with first-time ICD implantation were randomized to comprehensive cardiac rehabilitation versus usual care .


Gender differences in self-rated health and QoL and effect of rehabilitation were tested using t-tests .


Predictors of effect of rehabilitation were tested using logistic regression .


A total of @ patients ( mean age @ @ years ; @ men , @ women ) were included .


At hospital discharge , significant differences were found in physical component scale , mental component scale , social functioning , physical functioning , bodily pain , vitality , mental health , and QoL with men having higher scores .


Among men only , significant differences were found in VO@ ( rehabilitation : @ mL/min/kg -LSB- standard deviation ( SD ) @ -RSB- vs @ mL/min/kg -LSB- SD @ -RSB- and usual care : @ mL/min/kg -LSB- SD @ -RSB- vs @ mL/min/kg -LSB- SD @ -RSB- , P = @ ) , total exercise time ( rehabilitation : @ seconds -LSB- SD @ -RSB- vs @ seconds -LSB- SD @ -RSB- and usual care : @ seconds -LSB- SD @ -RSB- vs @ seconds -LSB- SD @ -RSB- , P = @ ) , and the mental component scale ( rehabilitation : @ points -LSB- SD @ -RSB- vs @ points -LSB- @ -RSB- and usual care : @ points -LSB- SD @ -RSB- vs @ points -LSB- SD @ -RSB- , P = @ ) .


After ICD implantation , significant gender differences were found in physical health , mental health , and QoL .


Effects of rehabilitation were found among men only and gender predicted effect of rehabilitation on the mental component scale .


To compare the analgesic effects of intra-articularly administered saline ( @ % NaCl ) solution , morphine , dexmedetomidine , and a morphine-dexmedetomidine combination in dogs undergoing stifle joint surgery for cranial cruciate ligament rupture .


Randomized , controlled , clinical trial .


@ dogs with cranial cruciate ligament rupture that underwent tibial tuberosity advancement ( TTA ) or tibial plateau leveling osteotomy ( TPLO ) .


Dogs received intra-articular injections of saline solution ( @ mL/kg -LSB- @ mL/lb -RSB- ) , morphine ( @ mg/kg -LSB- @ mg/lb -RSB- ) , dexmedetomidine ( @ g/kg -LSB- @ g/lb -RSB- ) , or a combination of morphine ( @ mg/kg ) and dexmedetomidine ( @ g/kg ) .


Intra-articular injections of the stifle joint were performed after completion of the corrective osteotomy procedure , just prior to skin closure .


Signs of pain were assessed every @ hours thereafter on the basis of mean behavioral and objective pain scores .


Dogs with pain scores exceeding predetermined thresholds were given hydromorphone ( @ mg/kg -LSB- @ mg/lb -RSB- , SC ) as rescue analgesia .


Time to rescue analgesia did not significantly differ between dogs that underwent TTA versus TPLO .


No significant difference in time to rescue analgesia was found among dogs receiving intra-articular injections of dexmedetomidine ( median , @ hours ; range , @ to @ hours ) , morphine ( median , @ hours ; range , @ to @ hours ) , or saline solution ( median , @ hours ; range , @ to @ hours ) .


However , time to rescue analgesia for dogs receiving intra-articular injection of the morphine-dexmedetomidine combination ( median , @ hours ; range , @ to @ hours ) was significantly longer than the time to rescue analgesia for other treatment groups .


Intra-articular administration of the morphine-dexmedetomidine combination provided longer-lasting postoperative analgesia , compared with either morphine or dexmedetomidine alone , in dogs undergoing TTA or TPLO .


Ninety lower-limb stage II or worse TAO patients were randomly divided into three groups : group A ( @ cases ) treated by intervention and oral administration of Chinese medicine ; group B ( @ cases ) treated by intervention alone ; and group C ( @ cases ) treated only with oral administration of Chinese medicine .


Therapeutic effects were observed , including the cure rate ; the recurrence rate after one month , three months , six months , nine months , and one year ; the ankle brachial indexes ; the incidence of complications ; and the level of C-reactive protein and erythrocyte sedimentation rate .


Group A had significantly better clinically curative effects , related indexes , and outcomes during the long-term follow-up survey , than that of groups B and C.


Integrated treatment is more effective for treating lower-limb stage II or worse TAO .


Results of the SYMPLICITY HTN-@ ( Renal Denervation in Patients With Uncontrolled Hypertension ) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at @ months post procedure .


This study sought to analyze the @-month SYMPLICITY HTN-@ results for the original denervation group , the sham subjects who underwent denervation after the @-month endpoint ( crossover group ) , and the sham subjects who did not undergo denervation after @ months ( non-crossover group ) .


Eligible subjects were randomized @:@ to denervation or sham procedure .


Subjects were unblinded to their treatment group after the @-month primary endpoint was ascertained ; subjects in the sham group meeting eligibility requirements could undergo denervation .


Change in blood pressure ( BP ) at @ months post randomization ( @ months for crossover subjects ) was analyzed .


The @-month follow-up was available for @ of @ denervation subjects and @ of @ non-crossover subjects ; @-month denervation follow-up was available for @ of @ crossover subjects .


In denervation subjects , the @-month office systolic BP ( SBP ) change was greater than that observed at @ months ( -@ @ mm Hg vs.-@ @ @ mmHg , respectively ; p = @ ) , but the @-h SBP change was not significantly different at @ months ( p = @ ) .


Thenon-crossover group office SBP decreased by-@ @ @ mmHg at @ months , but this response regressed to-@ @ @ mmHg ( p = @ ) at @ months , increasing to @ @ mmHg .


These data support no further reduction in office or ambulatory BP after @-year follow-up .


Loss of BPreduction in the non-crossover group may reflect decreased medication adherence or other related factors .


( Renal Denervation in Patients With Uncontrolled Hypertension -LSB- SYMPLICITY HTN-@ -RSB- ; NCT@ ) .


Effective interventions to improve immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients are desperately needed .


This paper describes the aims , design , and methods of the Teen Adherence in Kidney transplant , Effectiveness of Intervention Trial ( TAKE-IT ) study .


TAKE-IT is a multicentre , prospective , open-label , parallel arm randomized controlled trial that aims to determine the effectiveness of a clinic-based intervention , including educational , organizational , and behavioural components , in improving immunosuppressive medication adherence among adolescent and young adult kidney transplant recipients .


Individuals between @ and @ years of age who are at least @ months post-transplant and followed in one of the eight participating pediatric kidney transplant programs , or their affiliated adult transplant programs are eligible to participate .


All participating centers are tertiary care pediatric hospitals in Canada or the United States .


Adherence is monitored using an electronic multi-dose pillbox for all participants during a @-month run-in period , followed by a @-month intervention interval .


The primary outcome is ` taking adherence ' , defined as the proportion of prescribed doses of immunosuppressive medications that were taken , as measured using electronic monitoring.All participants meet with the study ` Coach ' at @ month intervals .


The intervention , administered by trained lay personnel , targets common adherence barriers .


In addition to forming an Adherence Support Team , intervention participants identify personal barriers to adherence and use Action-focused problem-solving to address them , have their electronic adherence data fed back to them , and have the option to receive email , text message , or visual cue dose reminders .


Participants in the control group meet with the coach but do not receive the other components of the intervention .


The study aims to have @ participants in each group complete the study .


Since recruitment began in Feb. @ , @ adolescents have been approached to participate , of whom @ have completed a baseline visit .


As of March @ , @ , @ had been randomized , and @ , @ , @ , and @ participants had completed @-month , @-month , @-month , and @-month visits respectively .


The aim of the study was to investigate @-year outcomes and predictors of repeat revascularization in patients treated with the Resolute zotarolimus-eluting stent ( R-ZES ) ( Medtronic , Minneapolis , Minnesota ) and XIENCE V everolimus-eluting stent ( EES ) ( Abbott Vascular , Abbott Park , Illinois ) in the RESOLUTE ( A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention ) All-Comers trial .


Data on long-term outcomes of new-generation drug-eluting stents are limited , and predictors of repeat revascularization due to restenosis and/or progression of disease are largely unknown .


Patients were randomly assigned to treatment with the R-ZES ( n = @,@ ) or the EES ( n = @,@ ) .


We assessed pre-specified safety and efficacy outcomes at @ years including target lesion failure and stent thrombosis .


Predictors of revascularization at @ years were identified by Cox regression analysis .


At @ years , the rates of target lesion failure ( @ % vs. @ % , p = @ ) , cardiac death ( @ % vs. @ % , p = @ ) , and target vessel myocardial infarction ( @ % vs. @ % , p = @ ) , clinically-indicated target lesion revascularization ( TLR ) ( @ % vs. @ % , p = @ ) , and definite/probable stent thrombosis ( @ % vs. @ % , p = @ ) were similar with the R-ZES and EES .


Independent predictors of TLR were age , insulin-treated diabetes , SYNTAX ( Synergy between PCI with Taxus and Cardiac Surgery ) score , treatment of saphenous vein grafts , ostial lesions , and in-stent restenosis .


Independent predictors of any revascularization were age , diabetes , previous percutaneous coronary intervention , absence of ST-segment elevation myocardial infarction , smaller reference vessel diameter , SYNTAX score , and treatment of left anterior descending , right coronary artery , saphenous vein grafts , ostial lesions , or in-stent restenosis .


R-ZES and EES demonstrated similar safety and efficacy throughout @ years .


TLR represented less than one-half of all repeat revascularization procedures .


Patient - and lesion-related factors predicting the risk of TLR and any revascularization showed considerable overlap .


( A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention -LSB- RESOLUTE-AC -RSB- ; NCT@ ) .


This was a randomized , open-label , three-way crossover study to assess the effects of AST-@ ( an orally administered spherical carbon adsorbent acting in the gastrointestinal tract without systemic circulation ) on the single-dose pharmacokinetics of metoprolol in an extended-release formulation ( metoprolol ER ) in healthy volunteers .


A total of @ subjects were singly administered metoprolol ER alone ( A ) , and metoprolol ER in combination with AST-@ simultaneously ( B ) and @ h later ( C ) .


The total exposure was more significantly reduced in both treatments B and C than that in treatment A ; the geometric mean ratios of area under the curve extrapolated to infinity ( AUC@ - ) for B/A and C/A were reduced by approximately @ % in both treatments B and C. Maximum observed plasma concentration ( Cmax ) of metoprolol in treatment B significantly decreased , whereas Cmax in treatment C was slightly decreased .


AST-@ treatment was unlikely to affect apparent first-order terminal elimination half-life ( T@/@ ) of metoprolol significantly .


Reduction in heart rate and blood pressure readings were similar across the treatment periods .


Coadministration of AST-@ and metoprolol ER was safe and was well tolerated .


Because AST-@ reduced gastrointestinal absorption of metoprolol ER , careful monitoring of heart rate and blood pressure is recommended in coadministration of AST-@ with metoprolol ER .


The purpose of this study was to compare the tolerance , efficacy , and safety of endobronchial ultrasound-guided transbronchial needle aspiration ( EBUS-TBNA ) with transesophageal endoscopic ultrasound-guided fine-needle aspiration ( EUS-FNA ) with an endobronchial ultrasound scope for the first pathologic diagnosis of lesions accessible by both procedures .


Patients who had lesions accessible by both EBUS-TBNA and EUS-FNA were enrolled and were randomized to undergo either procedure .


Patients quantified tolerance , and operators charted the quality of examination using a @-mm visual analog scale ( VAS ) .


A specific diagnosis was made in @ of @ patients ( @ % ) in the EBUS-TBNA group and in @ of @ patients ( @ % ) in the EUS-FNA group ( P = @ ) .


Compared with EBUS-TBNA , EUS-FNA was associated with a shorter duration of procedure ( median , @ min vs @ min ; P < @ ) , lower doses of IV midazolam ( mean , @ mg vs @ mg ; P = @ ) and intraairway lidocaine ( mean , @ mg vs @ mg ; P < @ ) , less frequent oxygen desaturations ( @ of @ vs two of @ , P < @ ) , and higher operator satisfaction ( P < @ ) .


There was no significant difference in patient tolerance according to the patients ' VAS .


Lymph node infection occurred in one patient in the EBUS-TBNA group and in two patients in the EUS-FNA group .


Both EBUS-TBNA and EUS-FNA provide high accuracy with good tolerance , although the occurrence of infectious complications should be monitored carefully .


EUS-FNA has the advantage of comparable tolerance with fewer doses of anesthetics and sedatives , a shorter procedure time , and fewer oxygen desaturations during the procedure .


The objective of this study was to determine the impact of nonfatal cardiovascular ( CV ) events on changes in health-related quality of life ( HRQL ) .


There is limited understanding of the impact of nonfatal CV events on long-term changes in HRQL in survivors ofmyocardial infarction ( MI ) .


The VALIANT ( Valsartan In Acute Myocardial Infarction ) trial enrolled @,@ patients post-MI complicated by Killip class II or higher ( scale measuring heart failure severity post-MI ranging from class I to IV ) and/or reduced ejection fraction .


The HRQL substudy included @,@ ( @ % ) patients who completed the EQ-@D with @ questions , with responses mapped to utility weight on a scale of @ to @ and a visual analog scale ( VAS ) ranging from @ ( worst ) to @ ( best ) imaginable health state .


EQ-@D was administered at baseline and @ , @ , @ , and @ months .


The trajectory of EQ-@D scores was developed by using linear mixed effects regression models with calculation of deviation from this trajectory after nonfatal CV events .


Patients who died before the next EQ-@D assessment were excluded .


Over a @-year period , @ patients experienced a nonfatal CV event and survived to have another EQ-@D assessment .


Their baseline EQ-@D scores were lower than patients without a subsequent nonfatal CV event ( VAS @ @ vs @ @ -LSB- p < @ -RSB- and US-based utility score @ @ vs @ @ -LSB- p < @ -RSB- ) .


These patients with CVevents experienced a trajectory-adjusted @ point decrease ( p < @ ) in VAS scores and a @ decrease ( p < @ ) in utility score after the nonfatal CV event .


MI survivors suffering a CV event experienced significantly worse HRQL than their previous trajectory , suggesting that generic instruments can be responsive to nonfatal events .


Reduction in nonfatal CV events may affect longitudinal changes in HRQL .


Vaccination with dendritic cells ( DC ) loaded with tumor antigens elicits tumor-specific immune responses capable of killing cancer cells without inducing meaningful side-effects .


Patients with advanced melanoma enrolled onto our phase II clinical studies have been treated with autologous DC loaded with autologous tumor lysate/homogenate matured with a cytokine cocktail , showing a clinical benefit ( PR+SD ) in @ % of evaluable cases to date .


The beneficial effects of the vaccine were mainly restricted to patients who developed vaccine-specific immune response after treatment .


However , immunological responses were only induced in about two-thirds of patients , and treatments aimed at improving immunological responsiveness to the vaccine are needed .


This is a phase II , `` proof-of-principle '' , randomized , open-label trial of vaccination with autologous DC loaded with tumor lysate or homogenate in metastatic melanoma patients combined with immunomodulating RT and/or preleukapheresis IFN - .


All patients will receive four bi-weekly doses of the vaccine during the induction phase and monthly doses thereafter for up to a maximum of @ vaccinations or until confirmed progression .


Patients will be randomized to receive : ( @ . )


three daily doses of @Gy up to @Gy radiotherapy delivered to one non-index metastatic field between vaccine doses @ and @ and , optionally , between doses @ and @ , using IMRT-IMAT techniques ; ( @ . )


daily @ MU subcutaneous IFN - for @days before leukapheresis ; ( @ . )


both @ and @ ; ( @ . )


neither @ nor @ .


At least six patients eligible for treatment will be enrolled per arm .


Daily @ MU IL-@ will be administered subcutaneously for @days starting from the second day after each vaccine dose .


Serial DTH testing and blood sampling to evaluate treatment-induced immune response will be performed .


Objective response will be evaluated according to immune-related response criteria ( irRC ) .


Based upon the emerging role of radiotherapy as an immunologic modifier , we designed a randomized phase II trial adding radiotherapy and/or preleukapheresis IFN - to our DC vaccine in metastatic melanoma patients .


Our aim was to find the best combination of complementary interventions to enhance anti-tumor response induced by DC vaccination , which could ultimately lead to better survival and milder toxicity .


To compare two therapeutic methods : electroacupuncture + massage + blocking therapy , and blocking therapy alone in the treatment of external humeral epicondylitis .


Eighty-six patients were randomized into two groups with @ in each .


The treatment group received electroacupuncture + massage + blocking therapy , while the control group received blocking therapy only .


A course of electroacupuncture treatment included therapy once a day for @ days .


There were @ treatments in a massage course and massage was given once a day , with a @-week interval given before the next course .


A course of blocking treatment included therapy once a week , for two total treatments , and generally no more than three times .


The therapeutic effects were evaluated with the visual analog scale ( VAS ) , grip strength index ( GSI ) score , and Mayo elbow performance score ( MEPS ) before treatment and at @ , @ , @ , and @ months after treatment to observe the total effective rate .


In the treatment and control groups before treatment and at @ , @ , @ , and @ months after treatment , the VAS scores were : @ + / - @ and @ + / - @ ; @ + / - @ and @ + / - @ ; @ + / - @ and @ + / - @ ; @ + / - @ and @ + / - @ ; and @ + / - @ and @ + / - @ , respectively .


The GSI scores were @ + / - @ and @ + / - @ ; @ + / - @ and @ + / - @ ; @ + / - @ and @ + / - @ ; @ + / - @ and @ + / - @ ; and @ + / - @ and @ + / - @ , respectively .


The MEPS of both groups were @ + / - @ and @ + / - @ ; @ + / - @ and @ + / - @ ; @ + / - @ and @ + / - @ ; @ + / - @ and @ + / - @ ; and @ + / - @ and @ + / -@ , respectively .


The total effective rates of the treatment and control groups at @ , @ , @ , and @ months after treatment were @ % and @ % ; @ % and @ % ; @ % and @ % ; and @ % and @ % , respectively .


Compared with the treatment group , the control group had greater joint function , better therapeutic effect , and lower pain intensity ( P < @ ) , indicating a high recurrence rate in the @th month after treatment .


There were no differences in VAS , GSI , or MEPS at @ , @ , and @ months after treatment ( P > @ ) between the two groups .


We found that both methods were effective for external humeral epicondylitis .


After @ months of treatment , the effects were good in both groups .


However , in the @th month , the control group had a relatively severe relapse .


After @ months , both groups relapsed .


The effect of electroacupuncture , massage , and blocking therapy used in combination lasted longer , delaying the recurrence of the disease .


The change in volume of anatomic structures is as a sensitive indicator of Alzheimer disease ( AD ) progression .


Although several methods are available to measure brain volumes , improvements in speed and automation are required .


Our objective was to develop a fully automated , fast , and reliable approach to measure change in medial temporal lobe ( MTL ) volume , including primarily hippocampus .


The MTL volume defined in an atlas image was propagated onto each baseline image and a level set algorithm was applied to refine the shape and smooth the boundary .


The MTL of the baseline image was then mapped onto the corresponding follow-up image to measure volume change ( MTL ) .


Baseline and @ months @D T@-weighted images from the Alzheimer Disease Neuroimaging Initiative ( ADNI ) were randomly selected for @ normal elderly controls ( NECs ) , @ subjects with mild cognitive impairment ( MCI ) and @ subjects with AD to test the algorithm .


The method was compared to the FreeSurfer segmentation tools .


The average MTL ( meanSEM ) was @mm ( @ ) in NEC , @mm ( @ ) in MCI and @mm ( @ ) in the AD group and was significantly different ( p < @ ) between all three groups .


The MTL was correlated with cognitive decline .


Results for the FreeSurfer software were similar but did not detect significant differences between the MCI and AD groups .


This novel segmentation approach is fully automated and provides a robust marker of brain atrophy that shows different rates of atrophy over @ years between NEC , MCI , and AD groups .


Although spironolactone has been shown to decrease morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction , its role in patients with heart failure and preserved left ventricular ejection fraction ( HFpEF ) is not well defined .


In this study we investigated the mechanisms involved when elderly women with HFpEF are treated with spironolactone .


Forty-eight women with HFpEF were enrolled in a randomized placebo-controlled trial and were assigned to @ mg spironolactone daily ( n = @ ) or placebo ( n = @ ) for @ months .


Six-minute walk distance , clinical composite score , Doppler echocardiography , and biomarkers were determined at baseline and after @ and @ months of therapy .


Six months of spironolactone treatment stabilized clinical symptoms , as demonstrated by significant worsening of the clinical composite score in the placebo group ( P = @ ) .


In addition , spironolactone treatment improved diastolic function by significantly increasing early diastolic tissue Doppler velocity of the lateral mitral annulus ( lateral e ' ; P = @ ) and significantly reducing the mitral peak E velocity to lateral e ' ratio ( lateral E/e ' ; P = @ ) .


Finally , spironolactone favorably affected remodeling through a reduction in myocardial fibrosis measured by a reduction in type III procollagen levels ( P = @ ) .


Six-minute walk distance did not significantly improve with spironolactone treatment compared with placebo .


Spironolactone stabilizes functional capacity and symptoms and improves diastolic function , possibly through its ability to suppress type III procollagen synthesis .


Orexin A ( OXA ) modulates food intake , energy expenditure , and lipid and glucose metabolism .


OXA regulates the secretion of insulin and glucagon , while glucose regulates OXA release .


Here , we evaluate the role of glucagon in regulating OXA release both in vivo and in vitro .


In a double-blind crossover study , healthy volunteers and type @ diabetic patients received either intramuscular glucagon or placebo .


Patients newly diagnosed with type @ diabetes underwent hyperinsulinaemic-euglycaemic clamp experiments , and insulin-hypoglycaemia tests were performed on healthy volunteers .


The primary endpoint was a change in OXA levels after intramuscular glucagon or placebo administration in healthy participants and patients with type @ diabetes .


Secondary endpoints included changes in OXA in healthy participants during insulin tolerance tests and in patients with type @ diabetes under hyperinsulinaemic-euglycaemic conditions .


Participants and staff conducting examinations and taking measurements were blinded to group assignment .


OXA secretion in response to glucagon treatment was assessed in healthy and obese mice , the streptozotocin-induced mouse model of type @ diabetes , and isolated rat pancreatic islets .


Plasma OXA levels declined in lean volunteers and in type @ diabetic patients injected with glucagon .


OXA levels increased during hyperinsulinaemic hypoglycaemia testing in healthy volunteers and during hyperinsulinaemic euglycaemic conditions in type @ diabetic patients .


Plasma OXA concentrations in healthy lean and obese mice and in a mouse model of type @ diabetes were lower after glucagon treatment , compared with vehicle control .


Glucagon decreased OXA secretion from isolated rat pancreatic islets at both low and high glucose levels .


OXA secretion declined in pancreatic islets exposed to diazoxide at high and low glucose levels , and after exposure to an anti-insulin antibody .


Glucagon further reduced OXA secretion in islets pretreated with diazoxide or an anti-insulin antibody .


Glucagon inhibits OXA secretion in humans and animals , irrespective of changes in glucose or insulin levels .


Through modifying OXA secretion , glucagon may influence energy expenditure , body weight , food intake and glucose metabolism .


This study aimed to determine the interaction between a high-fructose diet and PA levels on postprandial lipidemia and inflammation in normal-weight , recreationally active individuals .


Twenty-two men and women ( age , @ @ yr ; body mass index , @ @ kg m ( -@ ) ) consumed an additional @ g of fructose for @ d on two separate occasions : high physical activity ( PA ) ( approximately @,@ steps per day ) ( FR + active ) and low PA ( approximately @ steps per day ) ( FR + inactive ) .


A fructose-rich test meal was given before and at the end of each intervention .


Blood was sampled at baseline and for @ h after the meal for triglycerides ( TG ) , VLDL , total cholesterol , glucose , insulin , tumor necrosis factor - , interleukin @ , and C-reactive protein .


Log-transformed TG area under the curve ( AUC ) significantly increased from before ( @ @ mg dL ( -@ ) min for @ h ) to after ( @ @ mg dL ( -@ ) min for @ h , P = @ ) the FR + inactive intervention , with an @ % increase in peak TG ( P = @ ) and an @ % increase in peak VLDL ( P = @ ) .


Peak interleukin @ also increased by @ % after the FR + inactive intervention ( P = @ ) .


Insulin total AUC significantly decreased after FR + active intervention ( P = @ ) , with no change in AUC after the FR + inactive intervention .


No changes were observed in glucose , tumor necrosis factor - , and C-reactive protein concentrations ( P > @ ) .


Low PA during a period of high fructose intake augments fructose-induced postprandial lipidemia and inflammation , whereas high PA minimizes these fructose-induced metabolic disturbances .


Even within a young healthy population , maintenance of high PA ( > @,@ steps per day ) decreases susceptibility to cardiovascular risk factors associated with elevated fructose consumption .


Apnea of prematurity is a common condition that is usually treated with caffeine , an adenosine receptor blocker that has powerful influences on the central nervous system .


However , little is known about the long-term effects of caffeine on sleep in the developing brain .


We hypothesized that neonatal caffeine use resulted in long-term abnormalities in sleep architecture and breathing during sleep .


A total of @ ex-preterm children aged @-@ years who participated as neonates in a double-blind , randomized , controlled clinical trial of caffeine versus placebo underwent actigraphy , polysomnography , and parental sleep questionnaires .


Coprimary outcomes were total sleep time on actigraphy and apnea-hypopnea index on polysomnography .


There were no significant differences in primary outcomes between the caffeine group and the placebo ( adjusted mean difference of -@ -LSB- @ % confidence interval ( CI ) = -@ to @ min -RSB- ; P = @ for actigraphic total sleep time ; and adjusted rate ratio -LSB- caffeine/placebo -RSB- for apnea-hypopnea index of @ -LSB- @ % CI = @-@ @ -RSB- ; P = @ ) .


Polysomnographic total recording time and total sleep time were longer in the caffeine group , but there was no difference in sleep efficiency between groups .


The percentage of children with obstructive sleep apnea ( @ % of caffeine group versus @ % of placebo ; P = @ ) or elevated periodic limb movements of sleep ( @ % in caffeine group versus @ % in placebo group ) was high , but did not differ significantly between groups .


Therapeutic neonatal caffeine administration has no long-term effects on sleep duration or sleep apnea during childhood .


Ex-preterm infants , regardless of caffeine status , are at risk for obstructive sleep apnea and periodic limb movements in later childhood .


To determine whether increased antioxidant intake in women is associated with shorter time to pregnancy ( TTP ) among a cohort of couples being treated for unexplained infertility .


Secondary data analysis of a randomized controlled trial .


Academic medical center associated with a private infertility center .


Females with unexplained infertility .


None .


The time it took to establish a pregnancy that led to a live birth .


Mean nutrient intake exceeded the estimated average requirement ( EAR ) for vitamins C and E. No differences in mean intake of any of the antioxidants were noted between women who delivered a live-born infant during the study period vs. those who did not .


In multivariable models , intake of - carotene from dietary supplements was associated with shorter TTP among women with body mass index ( BMI ) @ kg/m ( @ ) ( hazard ratio -LSB- HR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ ) and women < @ y ( HR @ , @ % CI @-@ @ ) .


Intake of vitamin C from dietary supplements was associated with shorter TTP among women with BMI < @ kg/m ( @ ) ( HR @ , @ % CI @-@ @ ) and women < @ y ( HR @ , @ % CI @-@ @ ) .


Intake of vitamin E from dietary supplements among women @ y also was associated with shorter TTP ( HR @ , @ % CI @-@ @ ) .


Shorter TTP was observed among women with BMI < @ kg/m ( @ ) with increasing vitamin C , women with BMI @ kg/m ( @ ) with increasing - carotene , women < @ y with increasing - carotene and vitamin C , and women @ y with increasing vitamin E.


Bivalirudin ( Angiox , The Medicine 's Company , Parsippany , NJ ) , a synthetic direct thrombin inhibitor , when compared with standard antithrombotic therapy ( including unfractionated heparin -LSB- UFH -RSB- alone or plus a glycoprotein IIb/IIIa inhibitor ) determines a significant decrease of major and minor bleeding and similar protection against ischemic events both in elective and in urgent percutaneous coronary intervention ( PCI ) .


There is a lack of prospective clinical trial assessing the safety and the efficacy of bivalirudin compared with UFH alone in the subset of biomarker negative patients at high risk of bleeding undergoing to elective PCI through the femoral approach .


This is a single-center , investigator-driven , randomized , double-blind , controlled trial ( www.clinicaltrial.gov registration : NCT@ ) .


Consecutive patients at high bleeding risk ( score @ according to Nikolsky et al. ) undergoing elective PCI through the femoral approach will be screened for eligibility .


Included patients will be randomized ( ratio @ ) to bivalirudin ( Bivalirudin group ) and UFH ( UFH group ) .


The primary endpoint will be the rate of major bleeding ( REPLACE @ criteria ) .


We expect a major bleeding rate @ % in the UFH group versus a @ % event rate in the Bivalirudin group .


Aiming for a @ alpha and @ power , a total of @ patients will be needed .


This number will be increased by about @ % ( leading to a total of @ patients ) because of uncertainty about expected endpoint rates .


The present trial will give important information on what is the best anticoagulation regimen when performing PCI through the femoral approach in patients at high risk for bleeding .


Sexual and reproductive health ( SRH ) services for HIV-positive women and men often neglect their fertility desires .


We examined factors associated with pregnancy intent among recently diagnosed HIV-positive women ( N = @ ) and men ( N = @ ) who reported inconsistent condom use and were enrolled in an SRH intervention conducted in public sector HIV care clinics in Cape Town .


Participants were recruited when receiving their first CD@ results at the clinic .


All reported unprotected sex in the previous @ months .


Logistic regression identified predictors of pregnancy intent for the total sample and by gender .


About three fifths of men and one fifth of women reported intent to conceive in the next @ months .


In the full-sample multiple regression analysis , men -LSB- adjusted odds ratio ( AOR = @ ) -RSB- and those whose main partner shared intent to conceive ( AOR = @ ) had significantly higher odds of pregnancy intent ; those with more years of education ( AOR = @ ) and more biological children ( AOR = @ ) had lower odds of intending pregnancy .


In gender-specific analyses , partner sharing pregnancy intent was positively associated with intent among both men ( AOR = @ ) and women ( AOR = @ ) .


Among men , odds were lower among those having more biological children ( AOR = @ ) and those unemployed ( AOR = @ ) .


Among women , relying on hormonal contraception was negatively associated with intent ( AOR = @ ) , and main partner knowing her HIV status ( AOR = @ ) was positively associated with intent to conceive .


Findings underscore the importance of providing integrated SRH services , and we discuss implications for clinical practice and care .


To compare posterior capsule opacification ( PCO ) of a hydrophobic acrylic heparin surface modified intraocular lens ( HSM-IOL ) and an uncoated IOL ( UC-IOL ) @ year after implantation .


One hundred two eyes of @ patients underwent routine phacoemulsification with randomized implantation of a HSM-IOL in one eye ( the HSM-IOL group ) and a UC-IOL in the fellow eye ( the UC-IOL group ) .


Morphologic PCO evaluation was performed comparing digital photographs in retroillumination using the Evaluation of Posterior Capsule Opacification ( EPCO ) system , grading the density of the opacification from @ to @ ( @ = none , @ = minimal , @ = mild , @ = moderate , and @ = severe ) .


Distance visual acuities , subjective manifest refraction , pupil size , straylight measurements , flare in the anterior chamber using a laser flare meter , and contrast sensitivity were also evaluated .


The mean total EPCO score was slightly higher in the HSM-IOL group ( @ @ ) compared to the UC-IOL group ( @ @ ) , but did not reach statistical significance .


No statistically significant differences were found in the other main outcome parameters ( straylight measurement , distance visual acuities , flare in the anterior chamber , and mesopic and photopic contrast sensitivity ) when comparing both IOLs .


Although the HSM-IOL showed decreased flare @ day postoperatively , no statistically significant differences regarding PCO were found @ year postoperatively .


Unsupervised segmentation of multi-spectral images plays an important role in annotating infrared microscopic images and is an essential step in label-free spectral histopathology .


In this context , diverse clustering approaches have been utilized and evaluated in order to achieve segmentations of Fourier Transform Infrared ( FT-IR ) microscopic images that agree with histopathological characterization .


We introduce so-called interactive similarity maps as an alternative annotation strategy for annotating infrared microscopic images .


We demonstrate that segmentations obtained from interactive similarity maps lead to similarly accurate segmentations as segmentations obtained from conventionally used hierarchical clustering approaches .


In order to perform this comparison on quantitative grounds , we provide a scheme that allows to identify non-horizontal cuts in dendrograms .


This yields a validation scheme for hierarchical clustering approaches commonly used in infrared microscopy .


We demonstrate that interactive similarity maps may identify more accurate segmentations than hierarchical clustering based approaches , and thus are a viable and due to their interactive nature attractive alternative to hierarchical clustering .


Our validation scheme furthermore shows that performance of hierarchical two-means is comparable to the traditionally used Ward 's clustering .


As the former is much more efficient in time and memory , our results suggest another less resource demanding alternative for annotating large spectral images .


Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals .


We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction .


We conducted a pilot randomized controlled trial ( RCT ) where participants were randomly assigned to the intervention with routine education or routine education alone .


The outcomes evaluated were decisional conflict , decision self-efficacy , satisfaction with information , perceived involvement in care , and uptake of reconstruction following surgical consultation .


Trial feasibility and acceptability were evaluated , and effect sizes were calculated to determine the primary outcome for the full-scale RCT .


Of the @ patients enrolled , recruitment rate was @ % , treatment fidelity was @ % , and retention rate was @ % .


The Cohen 's d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education ( @ , @ % CI = @-@ @ ) , while the effect sizes of increase in decision self-efficacy ( @ , @ % CI = -@ -@ ) and satisfaction with information ( @ , @ % CI = -@ -@ ) were small .


A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction ( @/@ or @ % ) compared to the intervention group ( @/@ or @ % ) P = @ .


A pre-consultation educational group intervention improves patients ' shared decision-making quality compared to routine preoperative patient education .


A full-scale definitive RCT is warranted based on high feasibility outcomes , and the primary outcome for the main trial will be decisional conflict .


The incremental prognostic value of admission measurements of biomarkers beyond clinical characteristics and extent of coronary artery disease ( CAD ) in patients treated with primary percutaneous coronary intervention ( PPCI ) for ST-elevation myocardial infarction ( STEMI ) is unclear .


Centrally analyzed plasma for biomarker measurements was available in @,@ of the STEMI patients treated with PPCI in the PLATO trial .


Extent of CAD was graded by operators in association with PPCI .


We evaluated the prognostic value of high-sensitivity cardiac troponin T , N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) , and growth differentiation factor @ ( GDF-@ ) beyond clinical characteristics and extent of CAD using Cox proportional hazards analyses , C-index , and net reclassification improvement ( NRI ) .


Outcomes were cardiovascular death ( CVD ) and spontaneous myocardial infarction ( MI ) .


Angiographic data on extent of CAD improved the prediction of CVD compared to clinical risk factors alone , increasing the C-index from @ to @ , total NRI of @ .


Biomarker information provided additional prognostic value for CVD beyond clinical risk factors and extent of CAD , C-indices ranging from @ to @ for all biomarkers , but with a higher NRI for NT-proBNP .


Extent of CAD and high-sensitivity cardiac troponin T were not associated with spontaneous MI .


The prediction of spontaneous MI beyond clinical characteristics and extent of CAD ( C-index @ ) was improved by both NT-proBNP ( C-index @ , NRI @ ) and GDF-@ ( C-index @ , NRI @ ) .


Biomarker measurement on admission is feasible and provides incremental risk stratification in patients with STEMI treated with PPCI , with NT-proBNP and GDF-@ being most valuable due to the association with both CVD and spontaneous MI .


Use of the patient 's body surface area ( mg m ( -@ ) ) as a basis for dosing does not take individual variation in metabolic capacity and rate of clearance into account .


Here , we evaluated a novel approach for individual monitoring of short-lived cytotoxic agents formed from cytostatic drugs such as cyclophosphamide ( CP ) .


The accumulated blood dose of the cytotoxic active agent phosphoramide mustard ( PAM ) formed from CP was measured as a reaction product with hemoglobin ( Hb adduct ) .


This adduct , N - -LSB- @ - ( @-oxazolidonyl ) ethyl -RSB- - valyl Hb ( OzVal-Hb ) , was detached from Hb with the adduct FIRE procedure , and the formed analyte was quantified using LC-MS/MS .


This dose biomarker for PAM and the analytical procedure was evaluated in accordance with the guidelines on bioanalytical method validation formulated by the European Medicine Agency .


The evaluated method was applied to quantify blood dose levels of PAM in female breast cancer patients ( n = @ ) before and after three cycles of polychemotherapy regimes containing CP .


OzVal-Hb , a specific and stable biomarker , could be measured with great sensitivity ( lower limit of quantification = @ pmol g ( -@ ) Hb ) , high accuracy ( within @ % ) and good repeatability ( CV < @ % ) .


The inter-individual variability in the blood level of this adduct in women with breast cancer ( n = @ ) who received three doses of CP in combination with one or two other cytostatic drugs was @ % following the first dose and approximately @ % after each subsequent dose .


Measurement of the biomarker OzVal-Hb can be used to quantify the short-lived cytotoxic agent PAM in a single blood sample drawn several days after therapy .


This procedure may aid in individualizing doses of CP , thereby improving efficacy while both reducing the risk of and increasing the predictability of side-effects .


The objective of this study was to evaluate the effect of platelet-rich plasma ( PRP ) , platelet-rich fibrin ( PRF ) , and concentrated growth factor ( CGF ) on bone healing .


Twelve rabbits were included in this randomized , blinded , prospective study .


@-mm@-mm-sized defects were created in the parietal bone , filled with PRP , PRF , CGF , and void .


The bone mineral density and bone volume were analyzed with microscopic computed tomography ( micro-CT ) and histomorphometrics at the @th and @th week .


In micro-CT analysis , bone mineral density and bone volume were greater in the experimental group than in controls at both @th and @th week , but not among the experimental groups .


Similarly , histomorphometric examination revealed that more bone formation was seen in the experimental group .


The addition of PRP , PRF , and CGF had significantly increased bone formation at the @th week .


The effect of PRP , PRF , and CGF was similar and may be useful in the future to increase the success rate of bone grafting .


To evaluate the short-term efficacy and long-term preventive effect on recurrence in prevention and treatment of children allergic rhinitis treated with the multiple therapy at Dazhui ( GV @ ) as the main acupoint and acupoint plaster therapy .


One hundred and twenty cases of children allergic rhinitis were randomized into a triple-strong stimulation therapy group and an acupoint plaster therapy group , @ cases in each one .


In the triple-strong stimulation therapy group , Dazhui ( GV @ ) was the main acupoint , combined with one of Feishu ( BL @ ) , Zhiyang ( GV @ ) and Shenshu ( BL @ ) accordingly .


The heavy needling technique was adopted with the three-edged needle , followed by heavy cupping and heavy moxibustion .


The treatment was given once every @ days , continuously for @ times .


In the acupoint plaster therapy group , the acupoints selected were same as the triple-strong stimulation therapy group .


The self-prepared Chinese herbal plaster was used , @ h to @ h each one time , once every @ days , continuously for @ times .


The changes in the symptom and physical sign scores were observed before treatment , after treatment and in @ months follow-up visit after treatment in the two groups .


The clinical efficacy was compared between the two groups .


After treatment and in @ months follow-up visit after treatment , the symptom scores , physical sign scores and symptom scores of each item were different signi ficantly as compared with those before treatment in the triple-strong stimulation therapy group ( P < @ , P < @ ) , and the results in the triple-strong stimulation therapy group were better than those in the acupoint plaster therapy group ( all P < @ ) .


In @ months follow-up visit , the total effective rate was @ % ( @/@ ) in the triple-strong stimulation therapy group and was @ % ( @/@ ) in the acupoint plaster therapy group , indicating the significant difference ( P < @ ) .


The triple-strong stimulation therapy at Dazhui ( GV @ ) achieves the superior effect on the prevention and treatment of children allergic rhinitis as compared with the acupoint plas ter therapy and has good long-term effect of the prevention from recurrence .


Postoperative pain is an important health-care issue .


Patient-controlled analgesia ( PCA ) is considered the gold standard for systemic postoperative pain treatment .


Methadone PCA is used for patients with chronic pain and those in the palliative care setting .


However , its efficacy as a first-line drug for acute postoperative pain is unknown .


This study evaluated the use of postoperative methadone PCA after total hip arthroplasty ( THA ) compared with morphine PCA .


This was a randomized , double-blind , controlled , parallel-group study .


Patients were randomized into two groups : group methadone -- methadone PCA , and group morphine -- morphine PCA , for postoperative analgesia .


Drugs were delivered through PCA pumps throughout the first @ h after surgery ( T@ :@ , T@ :@ , T@ :@ , T@ :@ h ) .


Opioid consumption in @ h was significantly lower for group methadone than for group morphine .


Group methadone patients experienced significantly less pain than group morphine at rest .


Pain after movement was significantly lower in group methadone at T@ and T@ and marginally lower at T@ and T@ .


Adverse events more frequently reported were sleepiness , nausea , and vomiting , but no statistical difference between groups was found .


This study demonstrated that methadone PCA prompted less opioid consumption and lower pain scores at rest and at motion in comparison with morphine PCA as postoperative analgesia after THA .


The anti-EGFR monoclonal antibodies panitumumab and cetuximab are effective in patients with chemotherapy-refractory wild-type KRAS exon @ metastatic colorectal cancer .


We assessed the efficacy and toxicity of panitumumab versus cetuximab in these patients .


For this randomised , open-label , phase @ head-to-head study , we enrolled patients ( from centres in North America , South America , Europe , Asia , Africa , and Australia ) aged @ years or older with chemotherapy-refractory metastatic colorectal cancer , an Eastern Cooperative Oncology Group ( ECOG ) performance status of @ or less , and wild-type KRAS exon @ status .


Using a computer-generated randomisation sequence , we assigned patients ( @:@ ; stratified by geographical region and ECOG performance status , with a permuted block method ) to receive panitumumab ( @ mg/kg once every @ weeks ) or cetuximab ( initial dose @ mg/m ( @ ) ; @ mg/m ( @ ) once a week thereafter ) .


The primary endpoint was overall survival assessed for non-inferiority ( retention of @ % of the cetuximab treatment effect ; historical hazard ratio -LSB- HR -RSB- for cetuximab plus best supportive care vs best supportive care alone of @ ) .


The primary analysis included patients who received one or more dose of panitumumab or cetuximab , analysed per allocated treatment .


Recruitment for this trial is closed .


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


Between Feb @ , @ , and July @ , @ , we enrolled and randomly allocated @ patients , @ of whom began study treatment : @ received panitumumab and @ received cetuximab .


For the primary analysis of overall survival , panitumumab was non-inferior to cetuximab ( Z score -@ ; p = @ ) .


Median overall survival was @ months ( @ % CI @-@ @ ) with panitumumab and @ months ( @-@ @ ) with cetuximab ( HR @ ; @ % CI @-@ @ ) .


Panitumumab retained @ % ( @-@ @ ) of the effect of cetuximab on overall survival seen in this study .


The incidence of adverse events of any grade and grade @-@ was similar across treatment groups .


Grade @-@ skin toxicity occurred in @ ( @ % ) patients given panitumumab and @ ( @ % ) patients given cetuximab .


The occurrence of grade @-@ infusion reactions was lower with panitumumab than with cetuximab ( one -LSB- < @ % -RSB- patient vs nine -LSB- @ % -RSB- patients ) , and the occurrence of grade @-@ hypomagnesaemia was higher in the panitumumab group ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


We recorded one treatment-related fatal adverse event : a lung infection in a patient given cetuximab .


Our findings show that panitumumab is non-inferior to cetuximab and that these agents provide similar overall survival benefit in this population of patients .


Both agents had toxicity profiles that were to be expected .


In view of the consistency in efficacy and toxicity seen , small but meaningful differences in the rate of grade @-@ infusion reactions and differences in dose scheduling can guide physician choice of anti-EGFR treatment .


The present study was conducted to assess the effectiveness of Terminalia chebula on plaque and gingival inflammation and compare it with the gold standard chlorhexidine ( CHX @ % ) and distilled water as control ( placebo ) .


A double-blind randomised control trial was conducted among undergraduate students who volunteered .


They were randomly allocated into three study groups : @ ) Terminalia chebula mouthwash ( n = @ ) ; @ ) chlorhexidine ( active control ) ( n = @ ) ; @ ) distilled water ( placebo ) ( n = @ ) .


Assessment was carried out according to plaque score and gingival score .


Statistical analysis was carried out to compare the effect of both mouthwashes .


ANOVA and post-hoc LSD tests were performed using SPSS version @ with p @ considered statistically significant .


Our result showed that Terminalia chebula mouthrinse is as effective as chlorhexidine in reducing dental plaque and gingival inflammation .


The results demonstrated a significant reduction of gingival bleeding and plaque indices in both groups over a period of @ and @ days as compared to the placebo .


The results of the present study indicate that Terminalia chebula may prove to be an effective mouthwash .


Terminalia chebula extract mouthrinse can be used as an alternative to chlorhexidine mouthrinse as it has similar properties without the side-effects of the latter .


Celiac disease ( CeD ) is a prevalent autoimmune condition .


Recurrent signs and symptoms are common despite treatment with a gluten-free diet ( GFD ) , yet no approved or proven nondietary treatment is available .


In this multicenter , randomized , double-blind , placebo-controlled study , we assessed larazotide acetate @ , @ , or @ mg @ times daily to relieve ongoing symptoms in @ adults with CeD who had been on a GFD for @ months or longer and maintained their current GFD during the study .


The study included a @-week placebo run-in , @ weeks of treatment , and a @-week placebo run-out phase .


The primary end point was the difference in average on-treatment Celiac Disease Gastrointestinal Symptom Rating Scale score .


The primary end point was met with the @-mg dose of larazotide acetate , with fewer symptoms compared with placebo by modified intention to treat ( n = @ ) ( analysis of covariance , P = @ ; mixed model for repeated measures , P = @ ) .


The @-mg dose showed an effect on exploratory end points including a @ % decrease in celiac disease patient-reported outcome symptomatic days ( P = @ ) , a @ % increase in improved symptom days ( P = @ ) , a @ % or more reduction from baseline of the weekly average abdominal pain score for @ or more of @ weeks of treatment ( P = @ ) , and a decrease in the nongastrointestinal symptoms of headache and tiredness ( P = @ ) .


The @ - and @-mg doses were no different than placebo for any end point .


Safety was comparable with placebo .


Larazotide acetate @ mg reduced signs and symptoms in CeD patients on a GFD better than a GFD alone .


Although results were mixed , this study was a successful trial of a novel therapeutic agent targeting tight junction regulation in patients with CeD who are symptomatic despite a GFD .


Clinicaltrials.gov : NCT@ .


To evaluate the effect of eculizumab , a systemic inhibitor of complement component ( C@ ) , on the growth of geographic atrophy ( GA ) in patients with age-related macular degeneration ( AMD ) .


Prospective , double-masked , randomized clinical trial .


Patients with GA measuring from @ to @ mm ( @ ) based on spectral-domain optical coherence tomography imaging .


Patients were randomized @:@ to receive intravenous eculizumab or placebo over @ months .


In the eculizumab treatment arm , the first @ patients received a low-dose regimen of @ mg weekly for @ weeks followed by @ mg every @ weeks until week @ , and the next @ patients received a high-dose regimen of @ mg weekly for @ weeks followed by @ mg every @ weeks until week @ .


The placebo group was infused with saline .


Patients were observed off treatment for an additional @ weeks .


Both normal-luminance and low-luminance visual acuities were measured throughout the study , and the low-luminance deficits were calculated as the difference between the letter scores .


Change in area of GA at @ weeks .


Thirty eyes of @ patients were enrolled .


Eighteen fellow eyes also met inclusion criteria and were analyzed as a secondary endpoint .


For the @ study eyes , mean square root of GA area measurements standard deviation at baseline were @ @ and @ @ mm in the eculizumab and placebo groups , respectively ( P = @ ) .


At @ weeks , GA enlarged by a mean of @ @ and @ @ mm in the eculizumab and placebo groups , respectively ( P = @ ) .


At @ weeks of follow-up , GA enlarged by a mean of @ @ mm in the eculizumab-treated eyes and by a mean of @ @ mm in the placebo group ( P = @ , @ sample t test ) .


None of the eyes converted to wet AMD .


No drug-related adverse events were identified .


Systemic complement inhibition with eculizumab was well tolerated through @ months but did not decrease the growth rate of GA significantly .


However , there was a statistically significant correlation between the low-luminance deficit at baseline and the progression of GA over @ months .


We present a clinical trial establishing the feasibility of a control-to-range ( CTR ) closed-loop system informed by heart rate ( HR ) and assess the effect of HR information added to CTR on the risk for hypoglycemia during and after exercise .


Twelve subjects with type @ diabetes ( five men , seven women ; weight , @ @ kg ; age , @ @ years ; glycated hemoglobin , @ @ % ) participated in a randomized crossover clinical trial comparing CTR versus CTR+HR in two @-h admissions , each including @ min of mild exercise .


The CTR algorithm was implemented in the DiAs portable artificial pancreas platform based on an Android ( ) ( Google , Mountainview , CA ) smartphone .


We assessed blood glucose ( BG ) decline during exercise , the Low BG Index ( LBGI ) ( a measure of hypoglycemic risk ) , number of hypoglycemic episodes ( BG < @ mg/dL ) and overall glucose control ( percentage time within the target range @ mg/dL BG @ mg/dL ) .


Using HR to inform the CTR algorithm reduced significantly the BG decline during exercise ( P = @ ) , indicated marginally lower LBGI ( P = @ ) and fewer hypoglycemic events during exercise ( none vs. two events ; P = @ ) , and resulted in overall higher percentage time within the target range ( @ % vs. @ % ; P = @ ) .


LBGI and average BG remained unchanged overall , during recovery , and overnight .


HR-informed closed-loop control can be implemented in a portable artificial pancreas .


Although closed loop has been shown to reduce hypoglycemia , adding HR signal may further limit the risk for hypoglycemia during and immediately after exercise .


The most prominent effect of adding HR information is reduced BG decline during exercise , without deterioration of overall glycemic control .


Electroconvulsive therapy ( ECT ) is regarded by many clinicians as the most effective treatment for treatment-resistant bipolar depression , but no randomized controlled trials have been conducted , to the authors ' knowledge .


They compared efficacy measures of ECT and algorithm-based pharmacological treatment in treatment-resistant bipolar depression .


This multicenter , randomized controlled trial was carried out at seven acute-care psychiatric inpatient clinics throughout Norway and included @ bipolar disorder patients with treatment-resistant depression .


The patients were randomly assigned to receive either ECT or algorithm-based pharmacological treatment .


ECT included three sessions per week for up to @ weeks , right unilateral placement of stimulus electrodes , and brief pulse stimulation .


Linear mixed-effects modeling analysis revealed that ECT was significantly more effective than algorithm-based pharmacological treatment .


The mean scores at the end of the @-week treatment period were lower for the ECT group than for the pharmacological treatment group : by @ points on the Montgomery-sberg Depression Rating Scale ( SE = @ , @ % CI = @-@ @ ) , by @ points on the @-item version of the Inventory of Depressive Symptomatology-Clinician-Rated ( SE = @ , @ % CI = @-@ @ ) , and by @ points on the Clinical Global Impression for Bipolar Disorder ( SE = @ , @ % CI = @-@ @ ) .


The response rate was significantly higher in the ECT group than in the group that received algorithm-based pharmacological treatment ( @ % versus @ % ) , but the remission rate did not differ between the groups ( @ % versus @ % ) .


Remission rates remained modest regardless of treatment choice for this challenging clinical condition .


To determine whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department ( PACCI-ED ) , a @-item questionnaire , can help ED attendings accurately assess a patient 's asthma control and morbidity .


This was a randomized-controlled trial performed at an urban pediatric ED of children aged @-@ years presenting with an asthma exacerbation .


Parents answered PACCI-ED questions about their children 's asthma .


Attendings were randomized to view responses to the PACCI-ED ( intervention group ) or to be blinded to the completed PACCI-ED ( control group ) .


The two groups were compared on their empirical clinical assessment of : ( @ ) chronic asthma control categories , ( @ ) asthma trajectory ( stable , worsening or improving ) , ( @ ) patient adherence to controller medications , and ( @ ) burden of disease for the patient 's family .


The validated PACCI algorithm was used as the criterion standard for these four outcomes .


Accuracy of clinical assessment was compared between intervention and control groups using chi-squared tests and an intention-to-treat approach .


Seventeen ED attendings were enrolled in the study and @ children visits were included in the analysis .


There were no significant differences between the intervention and the control groups for child 's gender , age , race , and asthma characteristics .


Intervention group attendings were more accurate than control group attendings in assessing the category of chronic asthma control ( @ % versus @ % ; p = @ ) , disease trajectory ( @ % versus @ % ; p = @ ) , and the disease burden for families ( @ % versus @ % ; p = @ ) over the past @ months .


There was a trend towards more accuracy of intervention versus control attendings for estimating patient adherence to controller medications ( @ % versus @ % ; p = @ ) .


The PACCI-ED improves the assessment of asthma control , trajectory , and burden by ED attendings , and may help assessment of asthma medication adherence and prior asthma exacerbations .


The PACCI-ED can be used to improve provider assessment of asthma morbidity during pediatric ED visits for asthma exacerbations , and to identify children who may benefit from interventions to reduce asthma morbidity .


Remote ischemic preconditioning by transient limb ischemia reduces myocardial ischemia-reperfusion injury in patients undergoing percutaneous coronary intervention .


The aim of the study we report here was to assess the effect of remote ischemic preconditioning on endothelial function in patients with acute myocardial infarction who underwent primary percutaneous coronary intervention .


Forty-eight patients with acute myocardial infarction were enrolled .


All participants were randomly divided into @ groups .


In Group I ( n = @ ) , remote ischemic preconditioning was performed before primary percutaneous coronary intervention ( intermittent arm ischemia-reperfusion through @ cycles of @-minute inflation and @-minute deflation of a blood-pressure cuff to @ mm Hg ) .


In Group II ( n = @ ) , standard percutaneous coronary intervention without preconditioning was performed .


We assessed endothelial function using the flow-mediated dilation test on baseline , then within @-@ hours after percutaneous coronary intervention , and again on days @ and @ after percutaneous coronary intervention .


The brachial artery flow-mediated dilation results were significantly higher on the first day after primary percutaneous coronary intervention in the preconditioning group ( Group I ) than in the control group ( Group II ) ( @ % vs @ % , P = @ , and @ % vs @ % , P = @ , respectively ) , and this difference remained on the seventh day ( @ % vs @ % , P = @ , respectively ) .


We demonstrated for the first time that remote ischemic preconditioning before primary percutaneous coronary intervention significantly improves endothelial function in patients with acute myocardial infarction , and this effect remains constant for at least a week .


We suppose that the improvement of endothelial function may be one of the possible explanations of the effect of remote ischemic preconditioning .


The use of email and website as channels for workplace health information delivery is not fully explored .


This study aims to describe the rationale , design , and baseline findings of an email-linked website intervention to improve modifiable cancer risk factors .


Employees of a Malaysian public university were recruited by systematic random sampling and randomised into an intervention ( n = @ ) or control group ( n = @ ) .


A website was developed for the intervention and educational modules were uploaded onto the website .


The intervention group received ten consecutive weekly emails with hypertext links to the website for downloading the modules and two individual phone calls as motivational support whilst the control group received none .


Diet , lifestyle , anthropometric measurements , psychosocial factors and stages of change related to dietary fat , fruit and vegetable intake , and physical activity were assessed .


Participants were predominantly female and in non-academic positions .


Obesity was prevalent in @ % and @ % were at risk of co-morbidities .


Mean intake of fats was @ % , fruit was -@ serving/day and vegetable was < @ serving/day .


Less than @ % smoked and drank alcohol and about @ % were physically inactive .


The majority of the participants fell into the Preparation stage for decreasing fat intake , eating more fruit and vegetables , and increasing physical activity .


Self-efficacy and perceived benefits were lowest among participants in the Precontemplation/Contemplation stage compared to the Preparation and Action/Maintenance stages .


Baseline data show that dietary and lifestyle practices among the employees did not meet the international guidelines for cancer prevention .


Hence the findings warrant the intervention planned .


The TACT trial ( CRUK/@/@ ) compared adjuvant sequential FEC-docetaxel ( FEC-D ) chemotherapy with standard anthracycline-based chemotherapy of similar duration in women with early breast cancer .


Results at a median of @ years suggested no improvement in disease-free survival with FEC-D .


Given differing toxicity profiles of the regimens , the impact on quality of life ( QL ) was explored .


Patients from @ centres completed standardised QL questionnaires before chemotherapy , after cycles @ and @ , at @ , @ , @ and @ months and at @ years follow-up .


Patient diaries assessed frequency , associated distress and impact on daily activity of @ treatment related side effects .


@ patients ( @ FEC-D ; @ controls ) contributed assessments during @-@ months ; @ of whom participated again at @ years .


During chemotherapy , FEC-D impaired global health/QL and depression rates and significantly more QL domains than standard regimens .


Novel diary card ratings highlighted significantly more distress and interference with daily activities due to FEC-D side effects compared with standard treatment .


In both groups , most QL parameters returned to baseline levels by @ years and were unchanged at @ years .


Within expected negative effects of chemotherapy on wide ranging QL domains FEC-D patients reported greater toxicity , disruption and distress during treatment with no improvement in disease outcome at @ years than patients receiving standard anthracycline-based chemotherapy .


Findings should inform future patients of relative costs and benefits of adjuvant chemotherapy .


The combined efficacy analysis of the TEXT and SOFT trials showed a significant disease-free survival benefit with exemestane plus ovarian function suppression ( OFS ) compared with tamoxifen plus OFS .


We present patient-reported outcomes from these trials .


Between Nov @ , @ , and April @ , @ , @ premenopausal women with hormone-receptor positive breast cancer were enrolled in TEXT or SOFT to receive unmasked adjuvant treatment with @ years of exemestane plus OFS or tamoxifen plus OFS .


Gonadotropin-releasing hormone analogue triptorelin , bilateral oophorectomy , or bilateral ovarian irradiation were used to achieve OFS .


Chemotherapy use was optional .


Randomisation with permuted blocks was done with the International Breast Cancer Study Group 's internet-based system and was stratified by chemotherapy use and status of lymph nodes .


Patients completed a quality of life ( QoL ) form comprising several global and symptom indicators at baseline , every @ months for @ months , and then every year during years @ to @ .


Differences in the change of QoL from baseline between the two treatments were tested at @ months , @ months , and @ months with mixed-models for repeated measures for each trial with and without chemotherapy and overall .


The analysis was by intention to treat .


At the time of analysis , the median follow-up was @ years ( IQR @-@ ) ; treatment and follow-up of patients continue .


The trials are registered with ClinicalTrials.gov , as NCT@ ( TEXT ) and NCT@ ( SOFT ) .


Patients on tamoxifen plus OFS were more affected by hot flushes and sweats over @ years than were those on exemestane plus OFS , although these symptoms improved .


Patients on exemestane plus OFS reported more vaginal dryness , greater loss of sexual interest , and difficulties becoming aroused than did patients on tamoxifen plus OFS ; these differences persisted over time .


An increase in bone or joint pain was more pronounced , particularly in the short term , in patients on exemestane plus OFS than patients on tamoxifen plus OFS .


Changes in global QoL indicators from baseline were small and similar between treatments over the @ years .


Overall , from a QoL perspective , there is no strong indication to favour either exemestane plus OFS or tamoxifen plus OFS .


The distinct effects of the two treatments on the burden of endocrine symptoms need to be addressed with patients individually .


Coaction refers to the extent to which taking action on one behavior increases the odds of taking action on a second behavior .


This integrative study examines the generalization of coaction in three studies on weight-related behaviors .


Data from three randomized trials of tailored interventions ( n = @,@ , n = @,@ , and n = @,@ ) were examined to determine if coaction of behavior change occurred differentially in treatment and control groups .


In each analysis , the likelihood of progressing to the Action or Maintenance stages for the target behaviors was evaluated using logistic regression .


Despite differences in populations , targeted behaviors , levels of tailoring in interventions , and timing of follow-up assessments , @ out of @ ( @ % ) logistic regressions revealed significant coaction in the treatment group as opposed to only three out of @ ( @ % ) in the control condition .


In @/@ analyses , coaction of behavior change was larger on an absolute basis in the treatment group .


Individuals in the treatment group progressing to Action/Maintenance for one behavior were @-@ times more likely to make progress on another behavior compared to those in the treatment group who did not make such progress on the first behavior .


This study demonstrates that despite considerable variability in study design , coaction reliably occurs more in the presence of Transtheoretical-Model based multiple behavior change interventions .


Additional studies are needed to replicate these results in other behavioral areas and to examine the predictors of differential coaction .


The ability to consistently create coaction within multiple behavior interventions can increase the efficacy and cost-effectiveness of multiple behavior change interventions .


Routine tuberculosis culture remains unavailable in many high-burden areas , including Tanzania .


This study sought to determine the impact of providing mycobacterial culture results over standard of care -LSB- unconcentrated acid-fast ( AFB ) smears -RSB- on management of persons with suspected tuberculosis .


Adults and children with suspected tuberculosis were randomized to standard ( direct AFB smear only ) or intensified ( concentrated AFB smear and tuberculosis culture ) diagnostics and followed for @weeks .


The primary endpoint was appropriate treatment ( i.e. antituberculosis therapy for those with tuberculosis , no antituberculous therapy for those without tuberculosis ) .


Seventy participants were randomized to standard ( n = @ , @ % ) or intensive ( n = @ , @ % ) diagnostics .


At @weeks , @ % ( n = @ ) of participants in follow up randomized to intensive diagnostics were receiving appropriate care , vs. @ ( @ % ) of @ participants randomized to standard diagnostics ( p = @ ) .


Overall , @ ( @ % ) participants died ; antituberculosis therapy was associated with lower mortality ( @ % who received antiuberculosis treatment died vs. @ % who did not , p = @ ) .


Under field conditions in a high burden setting , the impact of intensified diagnostics was blunted by high early mortality .


Enhanced availability of rapid diagnostics must be linked to earlier access to care for outcomes to improve .


Patients with frontal lobe epilepsy ( FLE ) commonly demonstrate motor impairments , suggesting that frontal lobe seizures affect motor function .


However , the underlying mechanisms of these deficits are not known , nor has any study systematically examined motor organization in these patients .


We therefore examined cortical motor organization in a group of adult patients with FLE , using task-based fMRI .


Eleven right FLE patients , six left FLE patients , and ten control subjects underwent task-based fMRI .


Two tasks were performed using the right and left hands separately , and both hands together .


The first task was a finger-tapping task and the second task was a more complex coordination task .


Functional MR data were compared between patient groups and controls .


A laterality index of brain activation was also calculated between the epileptic and healthy hemisphere to determine hemispheric dominance during task performance to explore its relationship with a variety of patient-specific epilepsy factors .


Overall , right FLE patients demonstrated decreased BOLD activity in the epileptic hemisphere and increased BOLD activity in the healthy hemisphere compared to controls ( p < @ ) .


The comparison of left FLE patients to controls provided less conclusive differences , possibly due to the low number of left FLE patients studied .


Laterality indices of the coordination task were positively correlated to the number of months since the last seizure in both patient groups ( right FLE : rs = @ , left FLE : rs = @ ) .


Patients that had experienced a recent seizure relied more on the sensorimotor cortex of the healthy hemisphere during task performance , compared to those that were relatively seizure free ( p < @ ) .


Patients with FLE exhibited changes in motor BOLD activity that was dependent on the duration of seizure freedom .


These results demonstrate the presence of seizure-related alteration of cortical motor organization in FLE , which may underlie the motor deficits seen in these patients .


To examine the psychological sequelae associated with abnormal screening in the United Kingdom Collaborative Trial of Ovarian Cancer Screening ( UKCTOCS ) .


Prospective , longitudinal randomised control trial .


Sixteen UKCTOCS centres .


Women aged @-@ years randomised to annual multimodal screening , ultrasound screening or control groups .


Two groups were followed for @ years : ( @ ) a random sample ( n = @ ) , taken from all three study groups ; and ( @ ) an events sample ( n = @,@ ) of women with abnormal screens resulting in the need for repeat testing of either low or higher level intensity .


Patient-reported measures of anxiety ( scores ranging from @ to @ ) and psychological morbidity .


In the random sample the mean difference between anxiety scores after a repeat screening and those following an annual screening was @ ( @ % CI -@ , @ ) , and in the events sample it was @ ( @ % CI @ , @ ) .


The risk of psychological morbidity was only increased in the event sample for women requiring higher level repeat screening ( OR @ ; @ % CI @ , @ ) .


The risk of psychological morbidity in women with ovarian cancer was higher at both @ weeks ( OR @ ; @ % CI @ , @ ) and @ months ( OR @ ; @ % CI @ , @ ) following surgery .


Screening does not appear to raise anxiety but psychological morbidity is elevated by more intense repeat testing following abnormal annual screens , and in women after surgical treatment for ovarian cancer .


Lactate is a marker of hypoperfusion and may be used for risk assessment in critically ill patients .


Although evidence suggests that repeated lactate measurements are of clinical interest , how and when lactate should be analyzed is controversial .


Intravascular microdialysis provides a novel method for the continuous monitoring of lactate , which may be clinically beneficial in critically ill patients .


Circulating lactate levels were continuously monitored in @ patients undergoing cardiac surgery using either a separate single-lumen microdialysis catheter or a triple-lumen central venous catheter with an integrated microdialysis function .


The catheter was placed with the tip positioned in the superior vena cava .


Arterial blood gas samples were taken every hour to obtain reference values , and the lactate levels were analyzed in a blood gas analyzer .


A total of @,@ paired microdialysis-arterial blood gas lactate samples were obtained .


Bland-Altman analysis showed a bias ( mean difference ) limits of agreement ( @ SD ) of @ mmol/L .


The regression coefficient was @ ( P = @ ) .


Central venous microdialysis is an accurate and reliable method for continuous blood lactate monitoring in patients undergoing cardiac surgery .


The system may be useful for early lactate-guided therapy in critically ill patients .


The objective of this study was to evaluate and compare the effects of gliclazide-modified release ( gliclazide-MR ) , metformine ( MET ) and pioglitazone ( PIO ) monotherapies on glycemic control and conventional/non-conventional cardiovascular risk factors in patients with newly diagnosed type @ diabetes mellitus ( T@DM ) .


A single center , randomized , @-wk comparator-controlled clinical study was carried out in patients with newly diagnosed uncontrolled T@DM .


A total of @ patients were randomized into gliclazide-MR , metformin and pioglitazone groups .


Drugs were administered for @ months .


Anthropometric measurements , fasting plasma glucose ( FPG ) , postprandial plasma glucose ( PPG ) , HbA@c , insulin , HOMA-IR , lipid parameters , the markers of coagulation/fibrinolysis , inflammation and endothelial dysfunction were measured at baseline and at months @ , @ , and @ .


In the gliclazide-MR group , HC , FPG , HbA@c , insulin , HOMA-IR , TC , trigylcerides , Lp ( a ) , E-selectin and Hcy were significantly decreased after treatment compared to baseline .


In the MET group , BMI , WC , FPG , PPG , HbA@c , ICAM-@ and Hcy significantly decreased after treatment compared to baseline .


In PIO group , WC , HC , FPG , PPG , HbA@c , C-peptid , HOMA-IR , trigylcerides , vWF , IL-@ , ICAM-@ , E-selectin and Hcy significantly decreased after treatment compared to baseline , whereas , HDL-C increased .


At the end of the month @ , the decreases in insulin and HOMA-IR score were more pronounced with PIO compared to gliclazide .


Gliclazide-MR , MET and PIO monotherapies , were equally effective in proving glycemic control in patients with newly diagnosed , oral antidiabetic ( OAD ) - naive T@DM .


But , improvements in conventional/non-conventional cardiovascular risk factors were more pronounced in patients on PIO therapy compared to gliclazide and MET therapies .


Also , all of the @ drugs represent effective and safe first-line pharmacological treatment options in these patients .


In our increasingly obesogenic environment , in which high-calorie convenience foods are readily available , food choices can drastically affect weight and overall health .


Learned food preferences , which are developed through repeated pairings with positively and negatively valenced stimuli , can contribute to obesity susceptibility if positive attitudes toward high-calorie foods are developed .


Thus , the modification of automatic associations with food may be a viable strategy to promote healthier eating behaviors .


In this study , we investigated the ability of an implicit priming ( IP ) intervention to alter responses to visual food cues by using an evaluative conditioning approach .


The main objective was to implicitly ( i.e. , below conscious perception ) associate disgust with high-calorie foods with the aim of reducing liking of these foods .


Participants were randomly assigned to active or control IP .


In active IP ( n = @ ) , high-calorie food images were implicitly primed with negatively valenced images , and low-calorie food images were implicitly primed with positively valenced images .


In control IP ( n = @ ) , all food images were primed with neutral images of fixation crosses .


Food images were rated on the desire to eat immediately before and after IP .


A significant main effect of calorie ( high compared with low ; P < @ ) and a significant calorie-by-group ( active compared with control ) interaction ( P = @ ) were observed .


Post hoc tests identified a significantly greater high-calorie rating decline after active IP than after control IP ( P = @ ) .