The median follow-up was 6 years .


The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter ( 1.4 mmol per liter ) in the simvastatin-ezetimibe group , as compared with 69.5 mg per deciliter ( 1.8 mmol per liter ) in the simvastatin-monotherapy group ( P < 0.001 ) .


The Kaplan-Meier event rate for the primary end point at 7 years was 32.7 % in the simvastatin-ezetimibe group , as compared with 34.7 % in the simvastatin-monotherapy group ( absolute risk difference , 2.0 percentage points ; hazard ratio , 0.936 ; 95 % confidence interval , 0.89 to 0.99 ; P = 0.016 ) .


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


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


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


( Funded by Merck ; IMPROVE-IT ClinicalTrials.gov number , NCT00202878 . )


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


This study examined the effects of a supervised group exercise program on motivational outcomes and PA among BCS at 5-year follow-up .


The original study was a two-armed , randomized controlled trial comparing a 12-week supervised group exercise program to usual care among 203 BCS .


BCS for this follow-up study were contacted at 60 months postintervention and asked to complete assessments of motivational outcomes from the Theory of Planned Behavior and PA behavior using the Scottish Physical Activity Questionnaire .


Overall , 87 participants provided 5-year follow-up data with no differences in participation by group .


Analyses of covariance ( ANCOVAs ) revealed that supervised exercise had a significant positive effect on descriptive norm at 5-year follow-up ( mean = +0.6 ; 95 % CI = +0.1 to +1.1 ; d = +0.48 ; p = 0.021 ) .


Small positive effects were also noted for perceived behavioral control ( d = +0.18 ) , instrumental attitude ( d = +0.26 ) , and injunctive norm ( d = +0.35 ) , although they were not statistically significant .


Moreover , BCS who were more active at 5-year follow-up also reported more favorable perceived behavioral control ( d = +0.16 ) , instrumental attitude ( d = +0.28 ) , injunctive norm ( d = +0.24 ) , and descriptive norm ( d = +0.31 ) , although these differences were not statistically significant .


This trial provides suggestive evidence that a supervised exercise program has positive effects on motivational outcomes even after 5 years .


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


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


We performed a multicenter randomized controlled trial .


We enrolled women at 36 weeks of gestation or greater with a singleton live fetus in cephalic presentation , intact membranes , an unfavorable cervix ( dilation less than 3 cm ; if 2 cm , less than 80 % effaced ) , and no contraindication to labor or either study agent .


Women were allocated to either a cervical Foley catheter inflated to 30 mL or dinoprostone for up to 12 hours .


Oxytocin was allowed only after study agent removal .


The primary outcome was time from agent placement to delivery .


Secondary outcomes included delivery by 24 hours , vaginal delivery by 24 hours , time to vaginal delivery , cesarean delivery rate , and rate of tachysystole .


Analysis was by intent-to-treat .


We enrolled 376 patients , 185 allocated to Foley catheter and 191 to dinoprostone .


In the Foley catheter group , time to delivery was shorter ( median 21.6 compared with 26.6 hours ; P = .003 ) , more patients delivered within 24 hours ( 56 % compared with 40 % ; P = .003 ) , more delivered vaginally within 24 hours ( 44 % compared with 30 % ; P = .004 ) , and time to vaginal delivery was shorter ( median 20.1 compared with 24.3 hours ; P = .005 ) .


The cesarean delivery rates were 29 % compared with 39 % ( P = .07 ) .


Uterine tachysystole occurred in 0 % compared with 3 % ( P = .06 ) .


Starting labor inductions with a Foley catheter , compared with the dinoprostone vaginal insert , results in a shorter time to delivery and a higher proportion of women delivered and delivered vaginally within 24 hours .


Cesarean delivery rates were not statistically significantly different .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01402050 .


LEVEL OF EVIEDENCE : I.


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


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


In a prospective 12 month study , DMARD-naive RA patients were randomized to either a CDAI or SDAI arm and were treated with traditional DMARDs , increased on a monthly basis according to a predefined protocol to achieve low disease activity .


Of 102 patients ( 84 females , 96 Black Africans ) , the mean symptom duration was 3.0 years ( s.d. 3.8 ) and the mean 28-joint DAS ( DAS28 ) at baseline was 6.2 ( s.d. 1.2 ) .


By 12 months , the proportion of patients in the CDAI and SDAI groups achieving low disease activity ( 30 % and 32 % ) and remission ( 33 and 34 % ) were similar .


There were no significant differences in the mean DAS28 or its components or in HAQ Disability Index or health-related quality of life scores .


Baseline predictors of low disease activity at 12 months were shorter symptom duration ( P = 0.03 ) and lower HAQ-DI score ( P = 0.04 ) .


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


Levels of measles in England and Wales are at their highest for 18 years , and strategies targeting the different groups of parents who do not vaccinate their children continue to be needed .


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


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


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


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


A total of 220 first-time parents ( child aged 3-12 months ) were recruited .


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


Vaccine-uptake data were collected from GP practices .


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


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


Of the 220 first-time parents recruited to the study , 179 completed the baseline and post-intervention questionnaires .


MMR uptake was highest for those receiving the decision aid ( 42 out of 42 , 100 % ) versus usual practice ( 61 out of 62 , 98 % ) and leaflet arm ( 69 out of 75 , 92 % ) , and was associated with lower cost ( -9.20 versus usual practice and -7.17 versus leaflet ) .


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


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


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


National Surgical Adjuvant Breast and Bowel Project trial R-04 compared four chemotherapy regimens administered concomitantly with RT. .


Patients with clinical stage II or III rectal cancer who were undergoing preoperative RT ( 45 Gy in 25 fractions over 5 weeks plus a boost of 5.4 Gy to 10.8 Gy in three to six daily fractions ) were randomly assigned to one of the following chemotherapy regimens : continuous intravenous infusional fluorouracil ( CVI FU ; 225 mg/m ( 2 ) , 5 days per week ) , with or without intravenous oxaliplatin ( 50 mg/m ( 2 ) once per week for 5 weeks ) or oral capecitabine ( 825 mg/m ( 2 ) twice per day , 5 days per week ) , with or without oxaliplatin ( 50 mg/m ( 2 ) once per week for 5 weeks ) .


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


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


From September 2004 to August 2010 , 1,608 patients were randomly assigned .


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


Patients treated with oxaliplatin experienced significantly more grade 3 or 4 diarrhea ( P < .001 ) .


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


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


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


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


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


This double-blind , randomized , placebo-controlled trial examined the effects of a diet supplemented for 12 mo with foods that contained either 30 g of milled flaxseed [ milled flaxseed treatment ( FX ) group ; n = 58 ] or 30 g of whole wheat [ placebo ( PL ) group ; n = 52 ] in a patient population with peripheral artery disease ( PAD ) .


Plasma lipids were measured at 0 , 1 , 6 , and 12 mo. .


Dietary flaxseed in PAD patients resulted in a 15 % reduction in circulating LDL cholesterol as early as 1 mo into the trial ( P = 0.05 ) .


The concentration in the FX group ( 2.1 0.10 mmol/L ) tended to be less than in the PL group ( 2.5 0.2 mmol/L ) at 6 mo ( P = 0.12 ) , but not at 12 mo ( P = 0.33 ) .


Total cholesterol also tended to be lower in the FX group than in the PL group at 1 mo ( 11 % , P = 0.05 ) and 6 mo ( 11 % , P = 0.07 ) , but not at 12 mo ( P = 0.24 ) .


In a subgroup of patients taking flaxseed and CLM ( n = 36 ) , LDL-cholesterol concentrations were lowered by 8.5 % 3.0 % compared with baseline after 12 mo. .


This differed from the PL + CLM subgroup ( n = 26 ) , which increased by 3.0 % 4.4 % ( P = 0.030 ) to a final concentration of 2.2 0.1 mmol/L .


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


This trial was registered at clinicaltrials.gov as NCT00781950 .


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


70 patients with minimally classic or occult subfoveal choroidal neovascularisation were randomly assigned to 5 mg/mL TID , 2 mg/mL TID , and 5 mg/mL QD pazopanib eye drops for 28 days in a multicentre , double-masked trial with an optional safety extension for up to 5 additional months .


The primary outcomes were central retinal thickness ( CRT ) and best-corrected visual acuity ( BCVA ) at Day 29 .


No significant decrease from baseline in CRT was observed overall ; however , an exploratory analysis showed improvement in CRT ( mean decrease of 89 m ) in patients with the CFH TT genotype who received 5 mg/mL TID ( p = 0.01 , n = 5 ) .


Mean increases in BCVA were observed in the 5 mg/mL TID overall ( 4.32 letters ( p = 0.002 , n = 26 ) ) and in those that with CFH Y402H TT ( 6.96 letters ( p = 0.02 , n = 5 ) ) and CT ( 4.09 letters ( p = 0.05 , n = 9 ) ) genotypes .


No safety signals that precluded continued investigation were detected .


5 mg/mL pazopanib eye drops resulted in mean improvement in BCVA at Day 29 and improvements in vision .


However , improvement in macular oedema for age-related macular degeneration was found only in the subset of subjects with the CFH Y402H TT genotype , warranting further investigation .


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


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


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


In a double-blind , parallel group , phase 2/3 trial , participants were randomly assigned with permuted blocks in a 1:1 ratio to davunetide ( 30 mg twice daily , intranasally ) or placebo for 52 weeks at 48 centres in Australia , Canada , France , Germany , the UK , and the USA .


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


Primary endpoints were the change from baseline in PSP Rating Scale ( PSPRS ) and Schwab and England Activities of Daily Living ( SEADL ) scale at up to 52 weeks .


All participants and study personnel were masked to treatment assignment .


Analysis was by intention to treat .


The trial is registered with Clinicaltrials.gov , number NCT01110720 .


313 participants were randomly assigned to davunetide ( n = 157 ) or to placebo ( n = 156 ) , and 241 ( 77 % ) completed the study ( 118 and 156 in the davunetide and placebo groups , respectively ) .


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


The davunetide and placebo groups did not differ in the change from baseline in PSPRS ( median 118 [ 95 % CI 105 to 130 ] vs 118 [ 105 to 130 ] , respectively , p = 041 ) or SEADL ( -020 [ -020 to -017 ] vs -020 [ -022 to -017 ] , respectively , p = 092 ) .


54 serious adverse events were reported in each of the treatment groups , including 11 deaths in the davunetide group and ten in the placebo group .


The frequency of nasal adverse events was greater in the davunetide group than in the placebo group ( epistaxis 18 [ 12 % ] of 156 vs 13 [ 8 % ] of 156 , rhinorrhoea 15 [ 10 % ] vs eight [ 5 % ] , and nasal discomfort 15 [ 10 % ] vs one [ < 1 % ] ) .


Davunetide is not an effective treatment for PSP .


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


Allon Therapeutics .


To evaluate the efficacy and safety of intratympanic AM-101 in patients with persistent acute inner ear tinnitus after acute acoustic trauma , idiopathic sudden sensorineural hearing loss ( ISSNHL ) , or acute otitis media .


Prospective , double-blind , randomized , placebo-controlled study with follow-up visits on Days 7 , 30 , and 90 .


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


248 patients aged 16 to 65 years .


Three intratympanic injections of AM-101 ( 0.27 or 0.81 mg/ml ) or placebo over 3 consecutive days .


Efficacy was assessed by changes in minimum masking level ( MML ; primary end point ) , loudness match , tinnitus loudness , tinnitus annoyance , and sleep difficulties on a 0 to 100 numerical rating scale , THI-12 questionnaire , and patient global impression of change .


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


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


However , AM-101 0.81 mg/ml showed statistically significantly better improvement for tinnitus loudness , annoyance , sleep difficulties , and tinnitus impact in patients with tinnitus after noise trauma or otitis media .


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


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


The study established proof of concept for AM-101 in the treatment of tinnitus arising from cochlear glutamate excitotoxicity .


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


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


About 445 preschoolers with aged 3-6 years old from eight kindergartens in Pixian county , Chengdu were recruited into this trial from March to September , 2011 .


All subjects met the inclusion criteria were randomly divided into four groups using random number table : sole VA supplementation group ( VA group , a single oral dose of VA at about 200 000 units ) , sole iron supplementation group ( FE group , daily oral supplementation with the element iron 1-2 mgkg ( -1 ) d ( -1 ) for five days a week , lasting for 6 months ) , the combined supplementation of VA and iron group ( VF group ) and control group ( CO group , no VA and iron supplementation ) .


The concentration of serum VA , serum ferritin ( SF ) , serum transferring receptor ( sTfR ) , C-reactive protein ( CRP ) and hemoglobin ( Hb ) were measured from 3 ml vein blood .


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


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


The level of sTfR before intervention in VA group ( ( 1.78 0.17 ) mg/L ) was significantly higher than that of after intervention ( ( 1.18 0.11 ) mg/L ) ( t = 28.88 , P < 0.01 ) .


The levels of TFR-F index and TBIC in FE and VF groups before intervention ( ( 1.59 0.37 ) , ( 1.63 0.40 ) and ( 9.04 2.71 ) , ( 9.26 2.33 ) mg/kg , respectively ) were all lower than those of after intervention ( TFR-F index : ( 1.84 0.51 ) , ( 1.87 0.45 ) and TBIC : ( 12.42 3.49 ) , ( 13.01 2.98 ) mg/kg ) ( t values were 3.93 , 3.78 , 7.57 and 9.41 , respectively , all P values were < 0.01 ) .


The incidence of iron deficiency in VA , FE , and VF groups before intervention were 26 % ( 25/95 ) , 31 % ( 30/98 ) and 31 % ( 28/90 ) and were 41 % ( 39/95 ) , 10 % ( 10/98 ) and 18 % ( 16/90 ) for after intervention , respectively .


The difference of this index in VA , FE and VF groups were significant ( ( 2 ) values were 4.59 , 12.50 and 4.31 , respectively , all the P values were < 0.05 ) .


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


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


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


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


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


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


A randomized , single-blind , controlled experiment .


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


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


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


Data were collected July-October , 2013 and analysed using 22 anova .


A total of 157 nurses participated .


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


Subgroup analysis revealed significantly higher transmission success among more experienced nurses when the affective statement was present compared to when it was absent ( Kruskal-Wallis P = 0002 ) .


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


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


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


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


A total of 60 patients were randomized to either the SONO ( n = 30 ) or STIM ( n = 30 ) group .


For the block 40-50ml mepivacaine 1.5 % ( plexus ) and 5-10ml mepivacaine 0.5 % ( subcutaneous in the medial skin of the arm ) was used .


Anesthesia time was recorded as the primary end point .


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


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


No differences were observed between the groups in terms of onset time ( single nerves 10-20min , plexus 20-25min ) and success rate ( SONO 90 % , STIM 89 % ) .


Patient satisfaction as measured by block-related pain score ( VAS 2cm ) , complications ( vascular puncture SONO 7 % , STIM 11 % ; paresthesia SONO 21 % , STIM 22 % ) and patient acceptance ( SONO 92 % , STIM 91 % ) showed no differences .


Performance time was shorter in the SONO group ( 6.681.72 min vs. 8.052.58 , p = 0.02 ) .


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


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


We aimed to identify predictors of favourable long-term outcome of an education measure for parents of children with AD aged 3months to 7years in the framework of The German Atopic Dermatitis Intervention Study ( GADIS ) .


In an exploratory approach , the data of 274 child-parent pairs were analysed with respect to the influence of various somatic and psychological variables as possible predictors of treatment success .


Changes in parents ' QoL , SCORAD ( Scoring Atopic Dermatitis ) , topical corticosteroid use and parents ' knowledge about AD between baseline and 12-months ' follow-up were chosen as measures of long-term treatment success ( outcome ) .


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


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


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


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


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


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


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


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


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


We hypothesized that the incidence of SSI with the use of cyanoacrylate would be two-thirds ( 67 % ) lower than that with standard preparation of the surgical site , and performed an interim analysis of 50 patients to assess this .


Risk factors among the 50 patients in the study included smoking ( 28 % ) , hypertension ( 77 % ) , diabetes mellitus ( 36 % ) , and hypercholesterolemia ( 74 % ) .


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


The overall incidence of SSI was 3/47 ( 6 % ) , without differences between groups ; 9 % SSIs in the control group versus 4 % SSIs in the intervention group .


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


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


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


We studied 78 patients undergoing paediatric cardiac surgery with cardiopulmonary bypass ( CPB ) for the initial 12 h after operation .


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


Thereafter , we randomly assigned 100 patients to conventional or algorithm-guided blood product management , and assessed bleeding and red cell transfusion requirements .


CPB time , post-bypass rotational thromboelastometry ( ROTEM ( ) ) EXTEM amplitude at 10 min ( A10 ) , and FIBTEM-A10 were independently associated with chest tube drainage volume during the initial 12 h after operation .


Discriminative analysis determined cut-off values of 30 mm for EXTEM-A10 and 5 mm for FIBTEM-A10 , and estimated optimal intraoperative fresh-frozen plasma and platelet concentrate transfusion volumes .


Thromboelastometry-guided post-bypass blood product management significantly reduced postoperative bleeding ( 9 vs 16 ml kg ( -1 ) , P < 0.001 ) and packed red cell transfusion requirement ( 11 vs 23 ml kg ( -1 ) , P = 0.005 ) at 12 h after surgery , and duration of critical care stay ( 60 vs 71 h , P = 0.014 ) .


Rotational thromboelastometry-guided early haemostatic intervention by rapid intraoperative correction of EXTEM-A10 and FIBTEM-A10 reduced blood loss and red cell transfusion requirements after CPB , and reduced critical care duration in paediatric cardiac surgical patients .


UMIN Clinical Trials Registry UMIN000006832 ( December 4 , 2011 ) .


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


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


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


In this double-blind , placebo-controlled study , patients with chronic heart failure were randomized 2:1 to receive omecamtiv mecarbil or placebo in 2 sequential cohorts of escalating doses designed to achieve plasma concentrations previously shown to increase systolic function .


Patients underwent 2 symptom-limited exercise treadmill tests ( ETTs ) at baseline ( ETT1 and ETT2 ) and again before the end of a 20-h infusion of omecamtiv mecarbil ( ETT3 ) .


The primary pre-defined safety endpoint ( i.e. , the proportion of patients who stopped ETT3 because of angina at a stage earlier than baseline ) was observed in 1 patient receiving placebo and none receiving omecamtiv mecarbil .


No dose-dependent differences emerged in the proportion of patients stopping ETT3 for any reason or in the pattern of adverse events .


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


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


( Pharmacokinetics [ PK ] and Tolerability of Intravenous [ IV ] and Oral CK-1827452 in Patients With Ischemic Cardiomyopathy and Angina ; NCT00682565 ) .


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


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


In a prospective randomized study , we compared the clinical and radiological results of primary TKA using a mini-subvastus approach or a standard approach in 68 patients .


The mini-subvastus approach was used on 35 patients ( group I ) and the standard approach on 33 patients ( group II ) .


The mean follow-up was 28 months ( range 24-36 months ) .


Patients in group I had less blood loss and better visual analogue scale score at 1 day postoperatively .


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


The mean Knee Society function score , Oxford knee score , and range of movement were significantly better in group I up to 9 months after surgery ( all , p < 0.05 ) .


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


Reduced access and visibility in group I prolonged tourniquet time by an average of 22 min and resulted in five technical errors on radiographic evaluation .


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


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


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


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


We evaluated if a 1-month treatment with IVA ( 5 mg b.i.d. ) or - blockers ( carvedilol 6.25 mg b.i.d. or bisoprolol 1.25 mg b.i.d. ) improves the QOL ( assessed by SF-36 questionnaire ) in patients with CHF with reduced left ventricular ejection fraction ( < 50 % ) .


SF-36 was tested in 221 CHF patients ( mean age 64 6 years ) randomized into two groups ( IVA group - 110 patients ; - blockers group - 111 patients ) .


Data of QOL questionnaire and HR were collected by an interview during a clinical visit both at prescription time ( basal ) and after 1 month of therapy with IVA or - blockers .


QOL life and HR results after 1-month of therapy ( T1 ) with IVA were compared with basal values ( T0 ) .


The IVA versus - blockers treatment was associated with a significant improvement of physical functioning ( p < 0.001 vs. p < 0.01 ) , physical role functioning ( p < 0.001 vs. p < 0.01 ) , emotional role functioning ( p < 0.01 vs. p < 0.85 ) , and mental health scales ( p < 0.001 vs. p < 0.01 ) .


HR in the IVA group was significantly lower compared to the group of patients treated with - blockers ( 63 vs. 67 bpm ; p < 0.001 ) .


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


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


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


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


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


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


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


Based on power analysis and compensating for possible loss to follow-up , a minimum of 255 patients with borreliosis-attributed persistent symptoms are included .


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


All patients receive open-label ceftriaxone for two weeks .


Patients are then randomized ( ratio 1:1:1 ) to blinded oral follow-up treatment for 12 weeks with ( I ) doxycycline , ( II ) clarithromycin combined with hydroxychloroquine , or ( III ) placebo .


The primary outcome is the physical component summary score ( PCS ) of the RAND-36 Health Status Inventory ( RAND SF-36 ) at week 14 .


Secondary outcomes include physical and mental aspects of health-related quality of life ( assessed by the subscales of the RAND SF-36 ) , fatigue , neuropsychological evaluation , physical activity , and cost-effectiveness .


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


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


ClinicalTrials.gov : NCT01207739 , Netherlands Trial Register : NTR2469 .


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


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


Thirty-eight consecutive AF patients ( mean age 60 11 years , 28 paroxysmal AF ) undergoing CPVI were randomized to non-CF-guided ( n = 19 ) and CF-guided ( n = 19 ) groups .


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


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


In the CF group , CF was kept between 10 and 20 g during CPVI , whereas in the non-CF group , all CF information was blanked .


Radiofrequency energy at 30 W in the anterior and 25 W in the posterior LA wall was applied for 20-25 seconds at each point .


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


Mean CF in the non-CF and CF groups were 5.9 4.5 g and 11.1 4.3 g , respectively , for left-side CPVI , and 9.8 6.6 g and 12.1 4.8 g , respectively , for right-side CPVI ( both P < .001 ) .


The procedure and fluoroscopy times for CPVI in the non-CF and CF groups were 96 39 minutes and 59 16 minutes , respectively ( P < .001 ) , and 22 63 seconds and 9 20 seconds ( P = NS ) , respectively .


Total number of residual conduction gaps was 6.3 3.0 in the non-CF group and 2.8 1.9 in the CF group ( P < .001 ) .


During 6-month follow-up , 84.2 % of patients in the non-CF group and 94.7 % in the CF group were free from any atrial tachyarrhythmias ( P = .34 ) .


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


To measure neurodevelopment at 3 years of age in children with single right-ventricle anomalies and to assess its relationship to Norwood shunt type , neurodevelopment at 14 months of age , and patient and medical factors .


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


The Ages and Stages Questionnaire ( ASQ , n = 203 ) and other measures of behavior and quality of life were completed at age 3 years .


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


The Bayley Scales of Infant Development , Second Edition ( BSID-II ) scores from age 14 months were also evaluated as predictors .


Scores on each ASQ domain were significantly lower than normal ( P < .001 ) .


ASQ domain scores at 3 years of age varied nonlinearly with 14-month BSID-II .


More complications , abnormal growth , and evidence of feeding , vision , or hearing problems were independently associated with lower ASQ scores , although models explained < 30 % of variation .


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


Children with single right-ventricle anomalies have impaired neurodevelopment at 3 years of age .


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


Because only a modest percentage of variation in 3-year neurodevelopmental outcome could be predicted from early measures , however , all children with single right-ventricle anomalies should be followed longitudinally to improve recognition of delays .


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


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


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


In this prospective , multicenter , open-label , randomized controlled trial , 77 patients with mild-to-moderate community-acquired pneumonia with aspiration factors were enrolled and randomly assigned to receive moxifloxacin or levofloxacin plus metronidazole .


The primary efficacy variables were clinical outcomes in evaluable patients at a follow-up visit 7 to 14 days after the end of therapy .


Seven days after the end of therapy a clinical cure was achieved for 76.7 % ( 23 of 37 ) of efficacy-evaluable patients in the moxifloxacin group and 51.7 % ( 15 of 40 ) of patients in the levofloxacin plus metronidazole group .


There was a significant difference between the two groups ( ( 2 ) = 4.002 , P < 0.05 ) .


Bacteriological success rates were similar in the moxifloxacin group ( 93.3 % ) and levofloxacin plus metronidazole group ( 96.4 % ) , there was no significant difference between the two groups ( P > 0.05 ) .


The overall adverse event rate was 10.8 % ( 4/37 ) in the moxifloxacin group versus 17.5 % ( 7/40 ) in the levofloxacin plus metronidazole group , there was no significant difference between the two groups ( P > 0.05 ) .


No serious adverse events were observed .


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


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


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


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


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


This was a randomized controlled crossover study .


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


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


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


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


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


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


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


To evaluate intravitreal aflibercept 2 mg in patients with myopic choroidal neovascularization ( CNV ) .


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


Patients aged 18 years with high myopia ( -6.0 diopters or axial length of 26.5 mm ) , active myopic CNV , and best-corrected visual acuity ( BCVA ) of 73-35 Early Treatment Diabetic Retinopathy Study letters in the study eye were included .


Patients were randomized 3:1 to intravitreal aflibercept or sham .


In the intravitreal aflibercept arm , patients received 1 injection at baseline .


Additional injections were performed in case of CNV persistence or recurrence at monthly visits through week 44 .


In the sham arm , patients received sham injections through week 20 .


At week 24 , after assessment of the primary efficacy end point , sham patients received a mandatory intravitreal aflibercept injection followed by intravitreal aflibercept ( if disease persisted/recurred ) or sham injection every 4 weeks .


Mean change in BCVA from baseline to week 24 .


A total of 122 patients were randomized to intravitreal aflibercept ( n = 91 ) or sham ( n = 31 ) .


Baseline demographics were similar across groups .


At week 24 , patients in the intravitreal aflibercept and sham groups gained 12.1 and lost 2 letters , respectively ( P < 0.0001 ) .


By week 48 , patients in the intravitreal aflibercept and sham/intravitreal aflibercept groups gained 13.5 and 3.9 letters .


Patients in the intravitreal aflibercept group received 2 injections ( median ) in the first study quarter ( week 0-8 ) .


Median number of injections in quarters 2 to 4 was 0 .


Patients in the `` sham/intravitreal aflibercept '' group received 2 and 1 ( median ) intravitreal aflibercept injections in quarters 3 and 4 .


Central retinal thickness improved in parallel with visual gains .


Incidence of ocular adverse events was similar in both groups through week 48 ( 37.4 % vs. 38.7 ) ; most were assessed by investigators as mild .


No deaths occurred .


Intravitreal aflibercept 2 mg was effective for treatment of myopic CNV with clinically important visual and anatomic benefits achieved with a limited number of injections given in the first 8 weeks of treatment .


No new safety concerns occurred with treatment .


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


The aim of this study was to compare the pain perception and side effects during and after endovenous laser ablation with a 1470 nm diode laser using cold or room temperature tumescence anesthesia .


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


Group A received room temperature ( +24 ) and Group B received cold ( +4 ) tumescence fluid , which was used for local anesthesia in the track of great saphenous vein .


A visual analog score was recorded immediately after the procedure .


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


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


In Group A , the mean linear endovenous energy density was 59.5 J/cm and in Group B , it was 60.4 J/cm .


The average visual analog score after the endovenous laser ablation procedure in Group A was 5 and in Group B was 2 .


Third day after the procedure , the average visual analog score in Group A was 3 and in Group B was 1 .


Patients in Group B needed significantly less analgesics compared with patients in Group A ( p < 0.05 ) .


The most frequent side effects in both groups were ecchymosis , induration , and minor paraesthesia , all of which were more common in Group A ( p < 0.001 ) .


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


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


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


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


Randomized controlled trial ; Level of evidence , 1 .


A total of 40 patients ( 40 knees ) who underwent arthroscopic SB ACL reconstruction were included in this study .


Patients were randomized using a computer-generated sequence into 2 groups : 20 patients by the modified transtibial technique ( group 1 ) and 20 patients by the AM portal technique ( group 2 ) .


Clinical evaluations included the 2000 International Knee Documentation Committee ( IKDC ) subjective knee score , Lysholm knee score , Tegner activity scale , Lachman test , pivot-shift test , 2000 IKDC knee examination , and KT-1000 arthrometer measurement .


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


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


The mean distance of the femoral tunnel center location from the posterior condylar surface ( 0.8 % difference ; P = .167 ) and from the Blumensaat line ( 2.1 % difference ; P = .067 ) was similar in groups 1 and 2 .


The mean coronal obliquity of the femoral tunnel was significantly lower in group 1 than in group 2 ( 42.5 6.1 vs 49.3 7.2 , respectively ; P = .001 ) , but the mean sagittal obliquity was similar between the 2 groups ( 41.9 6.1 vs 43.3 5.4 , respectively ; P = .303 ) .


The mean area of the tunnel orifice was significantly greater in group 1 than in group 2 ( 11.6 1.4 9.2 1.6 mm vs 10.3 1.1 9.1 1.4 mm , respectively ; P = .013 ) .


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


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


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


To assess the efficacy of topical cyclosporine A ( CsA ) 0.05 % on the signs and symtomps in the management of VKC .


This is a placebo-controlled , randomized prospective study .


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


Patients were randomly assigned ( 1 : 1 ) to treatment with topical 0.05 % CsA eyedrops or a placebo ( artificial tears ) for a period of 4 weeks , 4 times daily .


Ocular signs and symptoms were in all patients scored at entry and at the end of 4 weeks .


When pre-treatment mean signs and symptoms scores were compared in both groups , there was no significant difference ( p > 0.05 ) .


However , mean post-treatment scores as regards signs and symptoms were found to be lower in cyclosporine group than those in placebo group ( p < 0.001 ) .


No side effects of the treatment with CsA 0.05 % eyedrops were observed .


It was found that topical CsA 0.05 % eyedrops were safe and effective in the treatment of patients with VKC .


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


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


Women with a body mass index 25 and < 39 , 18-45 y old , and a self-reported high intake of SSBs ( 250 kcal/d ) were randomly allocated to either the water and education provision ( WEP ) group ( n = 120 ) or the education provision ( EP ) only group ( n = 120 ) .


Each group received monthly nutrition counseling , and the WEP group received biweekly water deliveries for 9 mo. .


Three 24-h recalls , anthropometry , and demographic information were collected at baseline , and 3 , 6 , and 9 mo. .


Energy , macronutrient , sugar , SSB , fruit and vegetable , salty snack , cake and cookie , and fast food intakes were assessed in study completers ( n = 189 ) classified by intervention assignment and by actual water intake at every time point ( low < 1200 vs. high 1200 mL/d ) .


The WEP group reported greater decreases in SSB intake than the EP group ( from 20.9 % to 10.3 % of energy/d vs. from 20.1 % to 17.8 % ) .


Thirty-eight percent of the EP group and 84.3 % of the WEP group reported attaining a water intake 1200 mL/d .


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


However , the high actual water intake group reported greater increases vs. the lower intake group in intake of fruits and vegetables ( 117 vs. 47 g/d ) , as well as larger reductions in salty snacks ( 4.6 vs. 0.7 g/d ) and cakes and cookies ( 31.7 vs. 14.7 g/d ) .


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


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


This trial was registered at clinicaltrials.gov as NCT01245010 .


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


Older adults ( 65 years ) with chronic dizziness from vestibular disorders referred to VR were enrolled to the trial .


The control group ( n = 40 ) was submitted to the Cawthorne & Cooksey protocol and the experimental group ( n = 42 ) to the modified Cawthorne & Cooksey protocol which included multiple components .


Protocols were performed during individual 50-minute sessions , twice-weekly , for eight weeks .


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


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


144 elderly were referred to VR , 26.4 % declined to participate and 16.7 % were ineligible .


There were 51 session non-attendances , with disease being the most frequent reason .


Regardless of VR protocol , VAS dizziness intensity diminished along sessions ( p < 0.001 ) .


88.6 % of the participants reported improvement after treatment , and 22.9 % mentioned an increase in dizziness on follow-up .


Home exercises were no longer being performed by 21.4 % of the subjects after 3 months from discharge .


The final dropout rate was 14.6 % .


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


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


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


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


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


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


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


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


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


An improvement in OSATS ( P = 0.003 ) and BOSATS ( P = 0.003 ) scores was seen in the mental practice group compared with the conventional training group .


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


Mental imagery ability improved significantly following mental practice training ( P = 0.011 ) , but not in the conventional group ( P = 0.083 ) .


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


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


To determine the safety and tolerability of 3 doses of intranasal oxytocin ( Syntocinon ; Novartis , Bern , Switzerland ) administered to patients with frontotemporal dementia ( FTD ) .


We conducted a randomized , parallel-group , double-blind , placebo-controlled study using a dose-escalation design to test 3 clinically feasible doses of intranasal oxytocin ( 24 , 48 , or 72 IU ) administered twice daily for 1 week to 23 patients with behavioral variant FTD or semantic dementia ( clinicaltrials.gov registration number NCT01386333 ) .


Primary outcome measures were safety and tolerability at each dose .


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


All 3 doses of intranasal oxytocin were safe and well tolerated .


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


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


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


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


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


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


Following online registration , patients were randomly allocated by the automated intervention to either usual care , the web-based intervention only , or the web-based intervention with either basic nurse support ( 3 sessions in 3months ) or regular nurse support ( 7 sessions in 6months ) .


The main outcome measure ( intended as the primary outcome for the main trial ) was weight loss in kg at 12months .


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


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


At 12months mean weight loss was : usual care group ( n = 43 ) 2.44 kg ; web-based only group ( n = 45 ) 2.30 kg ; basic nurse support group ( n = 44 ) 4.31 kg ; regular nurse support group ( n = 47 ) 2.50 kg .


Intervention effect sizes compared with usual care were : d = 0.01 web-based ; d = 0.34 basic nurse support ; d = 0.02 regular nurse support .


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


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


Current Controlled Trials ISRCTN31685626 .


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


Secondary analysis of a parallel-group cluster randomized controlled trial of 20 weeks performed at two large industrial production units in Copenhagen , Denmark .


Women with neck pain > 30 mm VAS ( N = 131 ) were included in the present analysis .


The training group ( N = 77 ) performed specific resistance training for the neck/shoulder muscles three times a week , and the control group ( N = 54 ) received advice to stay active .


Participants of both groups registered neck pain intensity ( 0-100 mm VAS ) once a week .


Neck pain intensity was 55 mm ( SD 23 ) at baseline .


There was a significant group by time interaction for neck pain ( F-value 2.61 , P < 0.001 , DF = 19 ) .


Between-group differences in neck pain reached significance after 4 weeks ( 11 mm , 95 % CI 2 to 20 ) .


The time-wise change in pain showed three phases ; a rapid decrease in the training group compared with the control group during the initial 7 weeks , a slower decrease in pain during the following weeks ( week 8-15 ) , and a plateau during the last weeks ( week 16-20 ) .


Adherence to training followed a two-phase pattern , i.e. weekly participation rate was between 70-86 % during the initial 7 weeks , dropping towards 55-63 % during the latter half of the training period .


Four weeks of specific resistance training reduced neck pain significantly , but 15 weeks is required to achieve maximal pain reduction .


The time-wise change in pain followed a three-phase pattern with a rapid effect during the initial 7 weeks followed by a slower but still positive effect , and finally a plateau from week 15 and onwards .


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


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


Participants were 99 preservice trainees ( 48 control , 51 experimental ) and 103 in-service teachers ( 49 control , 54 experimental ) .


All participants completed 22 items from the Public Opinion Survey of Human Attributes-Stuttering ( POSHA-S ; St. Louis , 2005 ; translated into Arabic ) and 17 additional items pre and post treatment .


Participants in the experimental group viewed the awareness video .


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


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


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


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


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


We did a phase 3 study in previous non-responders with chronic hepatitis C virus ( HCV ) genotype 1 infection and compensated liver disease that related to the standard of care for these patients at the time this study was initiated .


We investigated whether simeprevir is non-inferior in terms of efficacy to telaprevir , each in combination with peginterferon alfa-2a and ribavirin .


We did this randomised , double-blind , phase 3 trial at 169 investigational sites in 24 countries .


We enrolled adults ( 18 years ) with chronic HCV genotype 1 infection , compensated liver disease , and plasma HCV RNA higher than 10000 IU/mL who were null or partial responders during at least one previous course of peginterferon alfa-2a and ribavirin treatment .


We randomly assigned ( 1:1 ) patients ( stratified by HCV genotype 1 subtype [ 1a plus other/1b ] and previous treatment response [ partial or null ] ) to receive simeprevir ( 150 mg once a day ) plus telaprevir placebo ( three times a day 7-9 h apart ) or telaprevir ( 750 mg three times a day ) plus simeprevir placebo ( once a day ) in combination with peginterferon alfa-2a and ribavirin for 12 weeks followed by 36 weeks of peginterferon alfa-2a and ribavirin alone .


The primary efficacy endpoint was sustained virological response 12 weeks after end of treatment ( SVR12 ) in the intention-to-treat and the per-protocol population .


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


We established a non-inferiority margin of 12 % .


Adverse events were reported descriptively .


This trial is registered with ClinicalTrials.gov , number NCT01485991 .


Patient screening began on Jan 19 , 2012 , and the last visit was on April 7 , 2014 .


We included 763 patients ( 472 previous null responders [ 62 % ] ) .


Simeprevir and peginterferon alfa-2a and ribavirin was non-inferior to telaprevir and peginterferon alfa-2a and ribavirin for SVR12 ( 54 % [ 203/379 ] vs 55 % [ 210/384 ] ; difference -11 % , 95 % CI -78 to 55 ; p = 00007 ) .


SVR12 was achieved in 70 % ( 101/145 ) versus 68 % ( 100/146 ) of previous partial responders and 44 % ( 102/234 ) versus 46 % ( 110/238 ) of previous null responders with simeprevir and peginterferon alfa-2a and ribavirin and telaprevir and peginterferon alfa-2a and ribavirin treatment , respectively .


We recorded differences between treatment groups in simeprevir or telaprevir-related adverse events ( 69 % [ 261/379 ] in the simeprevir group vs 86 % [ 330/384 ] in the telaprevir group ) , serious adverse events ( 2 % [ 8/379 ] vs 9 % [ 33/384 ] ) , and adverse events leading to simeprevir or telaprevir discontinuation ( 2 % [ 7/379 ] vs 8 % [ 32/384 ] ) .


Simeprevir once a day with peginterferon alfa-2a and ribavirin was well tolerated in HCV genotype 1-infected previous non-responders and was non-inferior to telaprevir , thus providing an alternative treatment in areas of the world where all-oral HCV regimens are not available or accessible .


Janssen .


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


In spite of widespread usage , the effectiveness and safety of combined treatments between conventional and complementary alternative medical treatment modalities has not been fully established in a rigorous randomized clinical trial ( RCT ) .


This pilot study will provide the clinical evidence to evaluate the feasibility and refine the protocol for a full-scale RCT on combined treatment of bee venom acupuncture ( BVA ) and non-steroidal anti-inflammatory drugs ( NSAIDs ) in patients with CNP .


This is a randomized , single-blind clinical trial with three parallel arms .


Sixty patients between 18 and 65years of age with non-specific , uncomplicated neck pain lasting for at least three months will be enrolled .


Participants will be randomly allocated into the BVA , NSAIDs or combined treatment group .


Assessors and statisticians will be blinded to the random allocation .


All researchers will receive training to ensure their strict adherence to the study protocol .


Patients from the BVA and combined treatment group will be treated with a bee venom increment protocol into predefined acupoints for six sessions over a three week period .


BVA intervention is developed through a comprehensive discussion among interdisciplinary spine disorder experts , according to the guidelines of Standards for Reporting Interventions in Clinical Trials of Acupuncture ( STRICTA ) .


Patients from the NSAIDs and combined treatment groups will be prescribed loxoprofen ( one tablet to be taken orally , three times a day for three weeks ) .


Bothersomeness from CNP measured using a visual analogue scale ( VAS ) will be the primary outcome assessed at screening , visit two ( baseline ) , four , six , eight ( 4th week assessment ) and nine ( 8th week assessment ) follow-up session .


VAS for pain intensity , neck disability index ( NDI ) , quality of life , depressive status and adverse experiences will also be analyzed .


Our study results will contribute to feasibility evaluation and to relevant RCT protocol development for a full-scale RCT on combined treatment of BVA and NSAIDs for CNP patients .


This study is registered with the United States ( US ) National Institutes of Health Clinical Trials Registry : NCT01922466 .


To discuss the impacts of moxibustion for regulating spleen and stomach function on the survival quality of the patients of end stage renal disease ( ESRD ) with maintenance hemodialysis ( MHD ) .


One hundred and nine cases of uremia with MHD from 3 hemodialysis centers were randomized into an observation group ( 58 cases ) and a control group ( 51 cases ) .


The regular hemodialysis and conventional medication were used in the two groups .


In the observation group , on the basis of the common treatment , moxibustion was applied to Zusanli ( ST 36 ) and Sanyinjiao ( SP 6 ) , 2-3 times a day , the treatment of 4 weeks made one session .


Totally , 3 sessions were required and the follow-up lasted for 3 months .


KDQOL-SF ( kidney disease quality of life short form,KDQOL-SFTM 1.3 ) was adopted for the questionnaire investigation on survival quality before treatment , after treatment and at the end of follow-up separately in the two groups .


After treatment , the survival quality scores in terms of physical functioning ( 83.62 + / -13.27 vs 79.32 + / - 22.17 ) , general health ( 58.88 + / - 20.24 vs 48.82 + / -20.89 ) and vitality ( 77.07 + / -15.56 vs 70.59 + / -22.61 ) in the observation group were higher than those in the control group ( all P < 0.05 ) .


In comparison before and after treatment in the same group , the survival quality scores in terms of physical functioning , general health , vitality and symptoms/problems were all improved in the observation group ( all P < 0.05 ) .


At the end of follow-up , the survival quality scores in terms of physical functioning , general health , mental health , social functioning , vitality , effects of kidney disease and cognitive function were higher in the observation group as compared with those in the control group ( all P < 0.05 ) .


In comparison of the results at the end of follow-up with those before treatment , the survival quality scores in terms of vitality , symptoms/problems and cognitive function in the observation group were improved ( all P < 0.05 ) .


The differences were not significant in all of the 19 fields of survival quality evaluation before and after treatment , and after follow-up in the control group ( all P > 0.05 ) .


Moxibustion for regulating spleen and stomach function improves the survival quality of the patients with hemodialysis in terms of physical functioning , general health and vitality , which benefits the psychological condition of the patients , resulting in the improvements of the survival quality in the fields of mental health , social functioning , effects of kidney disease and cognitive function .


The optimal duration of a public heart failure ( HF ) clinic programme is unknown .


This substudy of the NT-proBNP stratified follow-up in outpatient heart failure clinics ( NorthStar ) trial was designed to evaluate the effect of extended follow-up in an outpatient HF clinic on long-term adherence to guideline-based therapy .


Patients with HF with reduced EF on optimal medical therapy ( n = 921 ) were randomized to either extended follow-up in the HF clinic ( n = 461 ) or discharge to primary care ( n = 460 ) and followed for a median of 4.1 years ( range : 13 months to 6.1 years ) .


The effect of the HF clinic intervention on treatment adherence ( time to at least a 90 day break in treatment ) was estimated by drug dispensing from pharmacies of an ACE inhibitor/ARB , beta-blocker ( BB ) , or mineralocorticoid receptor antagonist ( MRA ) .


Median age was 69 years , 25 % were females , LVEF was 30 % , and 90 % were in NYHA class II-III .


The HF clinic intervention did not reduce time to a 90 day break in treatment with either an ACE inhibitor/ARB [ hazard ratio ( HR ) 0.82 , 95 % confidence interval ( CI ) 0.34-1 .97 , P = 0.650 ] , a BB ( HR 1.09 , 95 % CI 0.53-2 .66 , P = 0.820 ) , or an MRA ( HR 1.30 , 95 % CI 0.85-2 .00 , P = 0.238 ) .


Extended follow-up in an outpatient HF clinic did not improve long-term adherence to guideline-based therapy , and adherence did not deteriorate when follow-up was shifted from the HF clinic to primary care .


This phase II , open-label , randomised study evaluated whether patients with metastatic pancreatic cancer receiving erlotinib/gemcitabine derived survival benefits from increasing the erlotinib dose .


After a 4-week run-in period ( gemcitabine 1000 mg m ( -2 ) once weekly plus erlotinib 100 mg per day ) , patients with metastatic pancreatic cancer who developed grade 0/1 rash were randomised to receive gemcitabine plus erlotinib dose escalation ( 150 mg , increasing by 50 mg every 2 weeks ( maximum 250 mg ) ; n = 71 ) or gemcitabine plus standard-dose erlotinib ( 100 mg per day ; n = 75 ) .


The primary end point was to determine whether overall survival ( OS ) was improved by increasing the erlotinib dose .


Secondary end points included progression-free survival ( PFS ) , incidence of grade 2 rash , and safety .


Erlotinib dose escalation induced grade 2 rash in 29 out of 71 ( 41.4 % ) patients compared with 7 out of 75 ( 9.3 % ) patients on standard dose .


Efficacy was not significantly different in the dose-escalation arm compared with the standard-dose arm ( OS : median 7.0 vs 8.4 months , respectively , hazard ratio ( HR ) , 1.26 , 95 % confidence interval ( CI ) : 0.88-1 .80 ; P = 0.2026 ; PFS : median 3.5 vs 4.5 months , respectively , HR , 1.09 , 95 % CI : 0.77-1 .54 ; P = 0.6298 ) .


Incidence of adverse events was comparable between randomised arms .


The erlotinib dose-escalation strategy induced rash in some patients ; there was no evidence that the higher dose translated into increased benefit .


Globally , non-attendance for immunization appointments remains a challenge to healthcare providers .


A review of the 2011 immunization coverage for Kadoma City , Zimbabwe was 74 % for Oral Polio Vaccine ( OPV ) , Pneumococcal and Pentavalent antigens .


The immunization coverage was less than 90 % , which is the target for Kadoma City .


Adoption of short message services ( SMS ) reminders has been shown to enhance attendance in some medical settings .


The study was conducted to determine the effectiveness of SMS reminders on immunization programme for Kadoma City .


A randomized controlled trial was conducted at Kadoma City clinics in Zimbabwe .


Women who delivered and were residents of Kadoma City were recruited into the study .


In the intervention group , SMS reminders were sent at 6 , 10 and 14weeks in addition to routine health education .


In the non-intervention no SMS reminders were used , however routine health education was offered .


Data were collected using interviewer administered questionnaire .


Data were analyzed using Epi Info 7 , where frequencies , means , risk ratios and risk differences were generated .


A total of 304 participants were recruited , 152 for the intervention group and 152 for the non-intervention group .


The immunization coverage at 6weeks was 97 % in the intervention group and 82 % in the non-intervention group ( p < 0.001 ) .


At 14weeks immunization coverage was 95 % for intervention and 75 % for non-intervention group ( p < 0.001 ) .


Those who did not delay receiving immunization at 14weeks was 82 % for the intervention and 8 % for non-intervention group .


Median delay for intervention was 0days ( Q1 = 0 ; Q3 = 0 ) and 10days ( Q1 = 6 ; Q3 = 17 ) for non-intervention group .


The risk difference ( RD ) for those who received SMS reminders than those in the non intervention group was 16.3 % ( 95 % CI : 12.5-28 .0 ) at 14weeks .


Immunization coverage in the intervention group was significantly higher than in non-intervention group .


Overall increase in immunization coverage can be attributed to use of SMS .


ISRCTN70918594 .


Registration Date : 28 August 2014 .


Psoriasis and psoriatic arthritis ( PsA ) impair quality of life , including reduction in employment or job duties .


The PRESTA ( Psoriasis Randomized Etanercept STudy in Patients with Psoriatic Arthritis ) study , a randomized , double-blind , two-dose trial , examined the efficacy of etanercept treatment in patients with moderate-to-severe plaque psoriasis and PsA and the main results have been presented previously .


This analysis examined employment status , job duties and sick days , pre-defined endpoints in PRESTA , among this patient population .


Participants ( N = 752 ) were randomized to receive etanercept 50 mg twice weekly ( BIW ; n = 379 ) or 50 mg once weekly ( QW ; n = 373 ) for 12 weeks by subcutaneous injection .


All participants then received open-label etanercept 50 mg QW for 12 additional weeks , while remaining blinded to the randomization .


A pharmacoeconomic questionnaire was administered at baseline , week 12 and week 24 of treatment .


The questionnaire included employment status and changing job responsibilities and sick time taken due to psoriasis or PsA .


The statistical methods included analysis of covariance , t-test , Fisher 's exact test and McNemar 's test .


Last-observation-carried-forward imputation was used for missing data .


Employment was at least maintained from baseline to week 24 in both dose groups ( 56 % [ BIW/QW ] and 60 % [ QW/QW ] at baseline , 61 % and 60 % , respectively , at week 24 ) .


Among employed participants , the proportion of patients whose job responsibilities changed due to PsA decreased significantly from baseline to week 24 ( 17-23 % to 5-8 % ; p < 0.01 ) .


Similar results were seen with job responsibility changes due to psoriasis ( 11-14 % to 4 % ; p < 0.01 ) .


The number of monthly sick days also decreased from baseline to week 24 ( 2.4 days for both treatment groups to 0.7 ( BIW/QW ) and 1.1 ( QW/QW ) ; p0 .03 for each ) .


No significant differences between the treatment groups were observed for any economic endpoint at any time point .


For patients with moderate-to-severe plaque psoriasis and PsA , etanercept treatment resulted in reducing job responsibility changes due to disease and in reducing sick time .


Effective treatment of psoriasis and PsA may reduce missed work days .


A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany .


This decision is based on the final report of the Institute for Quality and Efficiency in Health Care in 2006 , which demonstrated through systematic reviews and meta-analysis of previous study projects , that an insufficient state of evidence regarding the use of negative pressure wound therapy for the treatment of acute and chronic wounds exists .


Further studies were therefore indicated .


The study is designed as a multinational , multicenter , prospective randomized controlled , adaptive design , clinical superiority trial , with blinded photographic analysis of the primary endpoint .


Efficacy and effectiveness of negative pressure wound therapy for wounds in both medical sectors ( in - and outpatient care ) will be evaluated .


The trial compares the treatment outcome of the application of a technical medical device which is based on the principle of negative pressure wound therapy ( intervention group ) and standard conventional wound therapy ( control group ) in the treatment of subcutaneous abdominal wounds after surgery .


The aim of the SAWHI-VAC study is to compare the clinical , safety and economic results of both treatment arms .


The study project is designed and conducted with the aim of providing solid evidence regarding the efficacy of negative pressure wound therapy .


Study results will be provided until the end of 2014 to contribute to the final decision of the Federal Joint Committee Germany regarding the general admission of negative pressure wound therapy as a standard of performance within both medical sectors .


Clinical Trials.gov NCT01528033German Clinical Trials Register DRKS00000648 .


Cough protects the lungs from aspiration .


We investigated whether respiratory muscle training may improve respiratory muscle and cough function , and potentially reduce pneumonia risk in acute stroke .


We conducted a single-blind randomized placebo-controlled trial in 82 patients with stroke ( mean age , 6414 years ; 49 men ) within 2 weeks of stroke onset .


Participants were masked to treatment allocation and randomized to 4 weeks of daily expiratory ( n = 27 ) , inspiratory ( n = 26 ) , or sham training ( n = 25 ) , using threshold resistance devices .


Primary outcome was the change in peak expiratory cough flow of maximal voluntary cough .


Intention-to-treat analyses were conducted using ANCOVA , adjusting for baseline prognostic covariates .


There were significant improvements in the mean maximal inspiratory ( 14 cmH2O ; P < 0.0001 ) and expiratory ( 15 cmH2O ; P < 0.0001 ) mouth pressure and peak expiratory cough flow of voluntary cough ( 74 L/min ; P = 0.0002 ) between baseline and 28 days in all groups .


Peak expiratory cough flow of capsaicin-induced reflex cough was unchanged .


There were no between-group differences that could be attributed to respiratory muscle training .


There were also no differences in the 90-day incidence of pneumonia between the groups ( P = 0.65 ) .


Respiratory muscle function and cough flow improve with time after acute stroke .


Additional inspiratory or expiratory respiratory muscle training does not augment or expedite this improvement .


http://www.controlled-trials.com .


Unique identifier : ISRCTN40298220 .


To determine whether prolonged androgen suppression ( AS ) duration before radiotherapy improves survival and disease control in prostate cancer .


One thousand five hundred seventy-nine men with intermediate-risk prostate cancer were randomly assigned to 8 weeks of AS followed by radiotherapy with an additional 8 weeks of concurrent AS ( 16 weeks total ) or to 28 weeks of AS followed by radiotherapy with an additional 8 weeks of AS ( 36 weeks total ) .


The trial sought primarily to detect a 33 % reduction in the hazard of prostate cancer death in the 28-week assignment .


Time-to-event end points are reported for up to 10 years of follow-up .


There were no between-group differences in baseline characteristics of 1,489 eligible patients with follow-up .


For the 8 - and 28-week assignments , 10-year disease-specific survival rates were 95 % ( 95 % CI , 93.3 % to 97.0 % ) and 96 % ( 95 % CI , 94.6 % to 98.0 % ; hazard ratio [ HR ] , 0.81 ; P = .45 ) , respectively , and 10-year overall survival rates were 66 % ( 95 % CI , 62.0 % to 69.9 % ) and 67 % ( 95 % CI , 63.0 % to 70.8 % ; HR , 0.95 ; P = .62 ) , respectively .


For the 8 - and 28-week assignments , 10-year cumulative incidences of locoregional progression were 6 % ( 95 % CI , 4.3 % to 8.0 % ) and 4 % ( 95 % CI , 2.5 % to 5.7 % ; HR , 0.65 ; P = .07 ) , respectively ; 10-year distant metastasis cumulative incidences were 6 % ( 95 % CI , 4.0 % to 7.7 % ) and 6 % ( 95 % CI , 4.0 % to 7.6 % ; HR , 1.07 ; P = .80 ) , respectively ; and 10-year prostate-specific antigen-based recurrence cumulative incidences were 27 % ( 95 % CI , 23.1 % to 29.8 % ) and 27 % ( 95 % CI , 23.4 % to 30.3 % ; HR , 0.97 ; P = .77 ) , respectively .


Extending AS duration from 8 weeks to 28 weeks before radiotherapy did not improve outcomes .


A lower than expected prostate cancer death rate reduced ability to detect a between-group difference in disease-specific survival .


The schedule of 8 weeks of AS before radiotherapy plus 8 weeks of AS during radiotherapy remains a standard of care in intermediate-risk prostate cancer .


Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers are the cornerstones of pharmacologic therapy in diabetic nephropathy .


Mineralocorticoid receptor blockers reduce proteinuria as single agents or add-on therapy to other renin-angiotensin-aldosterone system-inhibiting drugs in these patients .


The long-term benefits and ultimate role of mineralocorticoid receptor blockers in diabetic nephropathy remain unknown .


A clinical trial previously showed that the kalemic effect of spironolactone is higher than losartan when added to lisinopril in patients with diabetic nephropathy .


The purpose of this study was to investigate if renal potassium handling was primarily responsible for that observation .


In a blinded , randomized , three-arm placebo-controlled clinical trial , 80 participants with diabetic nephropathy taking lisinopril ( 80 mg ) were randomized to spironolactone ( 25 mg daily ) , losartan ( 100 mg daily ) , or placebo ( trial dates from July of 2003 to December of 2006 ) .


Serum potassium , aldosterone , and 24-hour urine sodium , potassium , and creatinine were measured over 48 weeks .


Differences were analyzed with repeated measures mixed models .


Mean follow-up serum potassium was 5.0 mEq/L for spironolactone , 4.7 mEq/L for losartan ( P = 0.05 versus spironolactone ) , and 4.5 mEq/L for placebo ( P < 0.001 versus spironolactone ; P = 0.03 versus losartan ) .


The difference in serum potassium was 0.23 mEq/L for losartan versus placebo ( P = 0.02 ) , 0.43 mEq/L for spironolactone versus placebo ( P < 0.001 ) , and 0.2 mEq/L for spironolactone versus losartan ( P = 0.05 ) .


Serum and urine potassium excretion and secretion rates were similar between groups throughout the study .


Spironolactone raised serum potassium more than losartan in patients with diabetic nephropathy receiving lisinopril , despite similar renal sodium and potassium excretion .


This finding suggests that extrarenal potassium homeostasis contributes to hyperkalemia in these patients .


A better understanding of extrarenal potassium homeostasis will provide an opportunity to use this drug more safely in patients with diabetic nephropathy as well as other patient populations .


The management of postoperative pain is paramount to facilitate the delivery of day case surgical programs .


In recent years , the complexity of procedures carried out has increased to include laparoscopic cholecystectomy .


The aim of this study was to evaluate the impact of laparoscopic-assisted 4-quadrant transversus abdominis plane ( TAP ) block vs periportal local anesthetic wound infiltration in managing postoperative pain .


A prospective , randomized , double-blinded trial was conducted with patients undergoing elective laparoscopic cholecystectomy .


Patients were randomized using computerized `` random number table '' into a test group that received laparoscopic-assisted TAP block with bupivacaine with periportal saline injection and a control group that received a laparoscopic-assisted TAP block with saline and periportal bupivacaine .


All patients received intraperitoneal instillation of bupivacaine in the gallbladder bed .


Postoperative pain scores were recorded using numerical rating scores at rest and coughing at dedicated time points .


Statistical analysis was carried out using GraphPad Prism software , version 5 ( GraphPad Software ) and p < 0.05 was considered significant .


Eighty patients ( 70 female and 10 male ) were enrolled ; 40 patients were randomized to each group .


Age , American Society of Anesthesiologists score , operative time , and BMI were comparable between the groups .


No adverse events were encountered with the administration of TAP blocks .


Numerical rating scores were significantly reduced in the test group at 1 , 3 , and 6 hours at rest ( p = 0.025 , p = 0.03 , and p = 0.007 , respectively ) .


Numerical rating score was significantly reduced at 1 , 3 , and 6 hours during coughing ( p = 0.026 , p = 0.02 , and p = 0.03 , respectively ) .


Difference in postoperative analgesic requirements between both groups was statistically insignificant ( p = 0.17 ) .


This analysis has confirmed the therapeutic benefit of laparoscopically delivered TAP blocks in elective laparoscopic cholecystectomy .


Sex differences in Parkinson disease clinical features have been reported , but few studies have examined sex influences on use of dopaminergic medication in early Parkinson disease .


The objective of this study was to test if there are differences in the type of dopaminergic medication used and levodopa equivalent daily dose between men and women with early Parkinson disease enrolled in a large multicenter study of Creatine as a potential disease modifying therapy - the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson Disease Long-Term Study-1 .


Baseline data of 1,741 participants from 45 participating sites were analyzed .


Participants from the United States and Canada were enrolled within five years of Parkinson Disease diagnosis .


Two outcome variables were studied : type of dopaminergic medication used and levodopa equivalent daily dose at baseline in the Long-Term Study-1 .


Chi-square statistic and linear regression models were used for statistical analysis .


There were no statistically significant differences in the frequency of use of different types of dopaminergic medications at baseline between men and women with Parkinson Disease .


A small but statistically significant difference was observed in the median unadjusted levodopa equivalent daily dose at baseline between women ( 300 mg ) and men ( 325 mg ) , but this was not observed after controlling for disease duration ( years since Parkinson disease diagnosis ) , disease severity ( Unified Parkinson 's Disease Rating Scale Motor and Activities of Daily Living Scores ) , and body weight .


In this large multicenter study , we did not observe sex differences in the type and dose of dopaminergic medications used in early Parkinson Disease .


Further research is needed to evaluate the influence of male or female sex on use of dopaminergic medication in mid - and late-stage Parkinson Disease .


to evaluate the clinical , hemodynamic , gas analysis and metabolic repercussions of high transient pressures of pneumoperitoneum for a short period of time to ensure greater security for introduction of the first trocar .


sixty-seven patients undergoing laparoscopic procedures were studied and randomly distributed in P12 group : n = 30 ( intraperitoneal pressure [ IPP ] 12mmHg ) and P20 group : n = 37 ( IPP of 20mmHg ) .


Mean arterial pressure ( MAP ) was evaluated by catheterization of the radial artery ; and through gas analysis , pH , partial pressure of oxygen ( PaO2 ) , partial pressure of CO2 ( PaCO2 ) , bicarbonate ( HCO3 ) and alkalinity ( BE ) were evaluated .


These parameters were measured in both groups at time zero before pneumoperitoneum ( TP0 ) ; at time 1 ( TP1 ) when IPP reaches 12mmHg in both groups ; at time 2 ( TP2 ) after five min with IPP = 12mmHg in P12 and after 5min with IPP = 20mmHg at P20 ; and at time 3 ( TP3 ) after 10min with IPP = 12mmHg in P12 and with return of IPP from 20 to 12mmHg , starting 10min after TP1 in P20 .


Different values from those considered normal for all parameters assessed , or the appearance of atypical organic phenomena , were considered as clinical changes .


there were statistically significant differences in P20 group in MAP , pH , HCO3 and BE , but within normal limits .


No clinical and pathological changes were observed .


high and transient intra-abdominal pressure causes changes in MAP , pH , HCO3 and BE , but without any clinical impact on the patient .


To evaluate the effect of oral prednisolone on recovery from tonsillectomy .


Prospective , randomized , controlled trial of 198 consecutive patients , aged 4 years and older , with no previous or known contraindications to steroid therapy .


All 198 patients scheduled for elective tonsillectomy with or without adenoidectomy from April 2013 to April 2014 were included .


The participants were then randomly assigned to receive a postoperative course of prednisolone 0.25 mg/kg/d or no prednisolone over 7 days .


During the first postoperative day , pain , type of diet ( none , fluid , soft , normal ) , type of activity ( none , bed rest , quiet , restricted , normal ) , presence of nausea and vomiting , postoperative bleeding rate , and sleep disturbance were assessed using questionnaires .


All patients were followed up on days 7 and 14 by endoscopic photographic examination of both tonsillar fossa and by completion of questionnaires .


No statistically significant differences in pain , diet , activity , rate of minor bleeding , nausea/vomiting , fever , or sleep disturbance were observed between the groups on day 1 .


On day 7 , however , in pediatric patients , differences in pain ( P = .001 ) , diet ( P = .001 ) , activity ( P = .004 ) , mean area of re-epithelialization ( P = .000 ) , fever ( P = .04 ) , and sleep disturbance ( P = .04 ) were observed .


On day 14 , differences in the mean area of re-epithelialization ( P = .000 , .001 ) remained in both pediatric and adult patients .


Oral prednisolone may be beneficial during recovery from tonsillectomy without causing any serious complications .


Advanced glycation end products and their cell-bound receptors are thought to mediate the adverse effects of vascular disease through oxidative stress , inflammation and endothelial dysfunction .


We examined the association between the soluble form of receptor for advanced glycation end products ( sRAGE ) and kidney disease .


In this case-cohort study nested within the Atherosclerosis Risk in Communities ( ARIC ) study , baseline sRAGE levels were measured in a cohort random sample of participants without kidney disease ( n = 1218 ) , and among participants who developed incident chronic kidney disease ( CKD ) [ estimated glomerular filtration rate ( eGFR ) < 60 mL/min/1 .73 m ( 2 ) and 25 % eGFR decline , n = 151 ] and end-stage renal disease ( ESRD ) [ entry in the US Renal Data System ( USRDS ) registry , n = 152 ] .


Baseline sRAGE levels were inversely related to baseline eGFR ( r = -0.13 ) .


After adjusting for age , sex and race , one interquartile range higher log10-transformed sRAGE was associated with development of CKD [ odds ratio : 1.39 ; 95 % confidence interval ( 95 % CI ) 1.06-1 .83 ; P = 0.02 ] and ESRD ( hazard ratio : 1.97 ; 95 % CI 1.47-2 .64 ; P < 0.001 ) .


These associations were not significant after eGFR adjustment .


High sRAGE levels are associated with incident CKD and ESRD risk , but not after adjustment for kidney function at baseline .


Future studies are needed to investigate specific mechanisms underlying the association of sRAGE with kidney disease risk .


The continuous progress in treatment options for pancreatic adenocarcinoma has lead to a re-evaluation of prognostic markers .


In this study the prognostic relevance of DNA Index and classical histopathological parameters with regard to disease-free ( DFS ) and overall survival ( OS ) was analyzed within the CONKO-001 patient population .


One hundred forty three fresh-frozen paraffin-embedded tissue samples of the resected tumor specimen of the CONKO-001 patient population were available for DNA index analysis to evaluate its impact on patient outcome .


Median DFS ( 7.3 vs. 14.3 months ; P = 0.004 ) and median OS ( 16.6 vs. 29.2 months ; P = 0.011 ) were significantly decreased in patients with a high DNA index ( > 1.4 ) .


Multivariate analysis revealed both DNA index ( DFS : P = 0.002 ; OS : P = 0.019 ) and tumor grading ( DFS : P = 0.004 ; OS : P = 0.004 ) as individual prognostic markers for DFS and OS .


The following prognostic subgroups were identified : good ( low DNA Index + G1/2 tumor grading ) , intermediate ( low DNA Index + G3 tumor grading or high DNA Index + G1/2 tumor grading ) , poor ( high DNA Index + G3 tumor grading ) .


The DNA index/tumor grading constellation may serve as a helpful guide for personalized treatment recommendations for adjuvant therapy of patients with pancreatic adenocarcinoma .


Lung cancer has high mortality rates , with up to 90 % of patients dying within one to two years of its onset .


It is essential to carry out research to attempt to solve the problems .


Most patients suffer serious fatigue resulting from various symptoms and its long-term treatment .


Furthermore , the other related complications such as underlying disease , anemia , malnutrition , nausea , and vomiting can reduced tolerance of chemotherapy .


Study showed that nurses are the only hospital staff involved in managing fatigue .


As it remains unclear to how fatigue should be managed , it is important to devise a strategy for providing a better service to help these patients survive longer .


To examine fatigue scores in patients with lung cancer after chemotherapy treatment , and to compare the scores of the group receiving the multidisciplinary education program in self-care group with those of the control group .


A randomized controlled trial was conducted in two groups .


The control group and the trial group were 30 patients in each .


Studied aged from 45 to 65 years old who were receiving chemotherapy at the Chemotherapy Unit in the Out-Patients Department , Rajavithi Hospital .


For a nine-week period , the control group received the hospital 's normal care program while the trial group received the multidisciplinary education program in self-care on fatigue .


Scores were allocated to each individual to reflect their levels of fatigue , nutrition , physical fitness , and depression , compared using Independent t-test , Fisher exact test , and Mann-Whitney U-test .


Sixty patients were enrolled into the study ( mean age = 56.10 ( 45-65 ) , male = 68.33 % ) .


The basic characteristics of each individual were not significantly different between the two groups .


The mean ( + / - SD ) fatigue scores were 2.98 + / - 1.96 and 3.99 + / - 1.64 for the control and the trial group respectively , and these figures were statistically significant ( p = 0.036 ) .


Nutrition scores were significantly higher in the trial group than in the control group ( p = 0.002 ) , but the other scores weight , albumin , physical fitness , and depression were not significantly different between the two groups .


The multidisciplinary education program in self-care results in decreased fatigue in patients with lung cancer who are receiving chemotherapy .


Therefore , it is recommended that more health professionals and specialists participate actively inpatient care to respond directly to patients ' needs .


This strategy should be adopted as the standard guideline for caring for patients with cancer who are receiving chemotherapy , and for patients with other conditions .


The present study aimed to determine that whether L-carnitine infusion could ameliorate fasting-induced adverse effects and improve outcomes .


In this 7-day , randomized , single-blind , placebo-controlled , pilot study , 15 metabolic syndrome ( MetS ) patients ( 11/4 F/M ; age 46.9 9.14 years ; body mass index [ BMI ] 28.2 1.8 kg/m2 ) were in the L-carnitine group ( LC ) and 15 ( 10/5 F/M ; age 46.8 10.9 years ; BMI 27.1 2.3 kg/m2 ) were in the control group ( CT ) .


All participants underwent a 5-day modified fasting therapy introduced with 2-day moderate calorie restriction .