A two-arm pragmatic pilot RCT was conducted comparing the standard service with a Telehealth-supported service and assessed the potential for progressing into a full RCT .


The co-primary outcome measures were the proportion of COPD patients readmitted to hospital and changes in patients ' self-reported quality of life .


The objectives were to assess the suitability of the methodology , produce a sample size calculation for a full RCT , and to give an indication of cost-effectiveness for both pathways .


Sixty three participants were recruited ( n = @ Standard ; n = @ Telehealth ) ; @ participants were excluded from analysis due to inadequate data completion or withdrawal from the Telehealth arm .


Recruitment was slow with significant gaps in data collection , due predominantly to an unanticipated @ % reduction of staff capacity within the clinical team .


The sample size calculation was guided by estimates of clinically important effects and COPD readmission rates derived from the literature .


Descriptive analyses showed that the standard service group had a lower proportion of patients with hospital readmissions and a greater increase in self-reported quality of life compared to the Telehealth-supported group .


Telehealth was cost-effective only if hospital admissions data were excluded .


Slow recruitment rates and service reconfigurations prevented progression to a full RCT .


Although there are advantages to conducting an RCT with data collection conducted by a frontline clinical team , in this case , challenges arose when resources within the team were reduced by external events .


Gaps in data collection were resolved by recruiting a research nurse .


This study reinforces previous findings regarding the difficulty of undertaking evaluation of complex interventions , and provides recommendations for the introduction and evaluation of complex interventions within clinical settings , such as prioritisation of research within the clinical remit .


The basal insulin analogue LY@ , a PEGylated insulin lispro with prolonged duration of action , was previously shown to be associated with modest weight loss in Phase @ , randomized , open-label trials in type @ ( N = @ ) and type @ ( N = @ ) diabetes mellitus ( T@DM and T@DM ) , compared with modest weight gain with insulin glargine .


Exploratory analyses were conducted to further characterize these findings .


Pearson correlations between change in body weight and other variables were calculated .


Continuous variables were analysed using a mixed linear model with repeated measurements .


Proportions of subjects with weight loss were analysed using Fisher 's exact test for T@DM and Nagelkerke 's method for T@DM .


Weight loss was more common in LY@-treated patients than in patients treated with insulin glargine ( T@DM : @ vs. @ % , p = @ ; T@DM : @ vs. @ % , p < @ ) .


More LY@-treated patients experienced @ % weight loss compared to patients treated with glargine ( T@DM : @ vs. @ % , p = @ ; T@DM : @ vs. @ % , p < @ ) .


In both the T@DM and T@DM studies , weight change did not correlate with baseline body mass index ( BMI ) , or change in HDL-cholesterol in either treatment group .


No consistent correlations were found across both studies between weight change and any of the variables assessed ; however , weight change was significantly correlated with hypoglycaemia rate in glargine-treated T@DM patients .


In two Phase @ trials , improved glycaemic control with long-acting basal insulin analogue LY@ is associated with weight loss in previously insulin-treated patients .


This weight change is independent of baseline BMI or hypoglycaemia .


Endogenous hydrophobic bile acids may be a pathogenetic factor of biliary complications after orthotopic liver transplantation ( OLT ) .


This study was designed to investigate the effects of hydrophilic ursodeoxycholic acid ( UDCA ) , when administered early after OLT , on serum liver tests and on the incidence of biliary complications .


A total of @ adult patients undergoing OLT were randomly assigned to one of two groups for receipt of UDCA ( @ to @ mg/kg/d for @ weeks , n = @ ) or a placebo ( n = @ ) .


All patients underwent serum liver testing and measurement of serum bile acids during the @ weeks following OLT.Patients with T-tube underwent measurement of biliary bile acids during the @ weeks following OLT.Biliary complications , as well as patient and graft survival rates , were analyzed during the follow-up period ( mean of @ months ) .


At post-OLT days @ , @ and @ , the UDCA-treated patients showed significantly lower levels of alanine aminotransferase , aspartate aminotransferase and gamma glutamyl transpeptidase ( all P less than @ ) .


In addition , the UDCA-treated patients showed significantly lower incidence of biliary sludge and casts within the first year post-OLT ( @ % vs. @ % ; x@ = @ , P = @ ) .


However , there were no significant differences for the incidence of other biliary complications at post-OLT years @ , @ and @ .


The graft and patient survival rates were also similar between the two groups .


UDCA , when administered early after OLT , improves results from serum liver tests and decreases the incidence of biliary sludge and casts within the first postoperative year .


Tivantinib , a MET receptor tyrosine kinase inhibitor , demonstrated increased anticancer activity in preclinical and early clinical studies when combined with erlotinib .


Our study aimed to confirm efficacy and safety of the combination in previously treated patients with non-small-cell lung cancer ( NSCLC ) .


Patients with advanced nonsquamous NSCLC previously treated with one to two systemic regimens , including a platinum doublet , were randomly assigned at a @:@ ratio to receive erlotinib @ mg daily plus oral tivantinib @ mg twice daily ( E + T ) or erlotinib plus placebo ( E + P ) until disease progression .


Tumor specimens were evaluated for EGFR and KRAS mutations , MET expression , and MET gene amplification .


The primary end point was overall survival ( OS ) .


Secondary and exploratory objectives included progression-free survival ( PFS ) , OS in molecular subgroups , and safety .


The study enrolled @,@ patients and was discontinued for futility at the interim analysis .


OS did not improve with E + T versus E + P ( median OS , @ v @ months , respectively ; hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ; P = @ ) , even though PFS increased ( median PFS , @ v @ months ; HR , @ ; @ % CI , @ to @ ; P < @ ) .


Exploratory subgroup analyses suggested OS improvement in patients with high MET expression ( HR , @ ; @ % CI , @ to @ ) .


Most common adverse events occurring with E + T versus E + P were rash ( @ % v @ % , respectively ) , diarrhea ( @ % v @ % ) , asthenia or fatigue ( @ % v @ % ) , and neutropenia ( grade @ to @ ; @ % v @ % ) .


E + T was well tolerated and increased PFS but did not improve OS in the overall nonsquamous NSCLC population .


The aim of the current study was to examine the effect of body weight support treadmill training ( BWSTT ) with power-assisted functional electrical stimulation on functional movement and gait in stroke patients .


Thirty stroke patients were randomly assigned to either the experimental group ( n = @ ) or the control group ( n = @ ) .


All subjects participated in the same standard rehabilitation program .


In addition , the experimental group participated in BWSTT with power-assisted functional electrical stimulation for @ mins per day , five times a week , for @ wks , and those in the control group participated in BWSTT for @ minutes per day , five times a week , for @ wks .


Functional movement was assessed using the Berg Balance Scale , the Timed Up and Go test , and the Stroke Rehabilitation Assessment of Movement .


Gait ability was assessed using an electrical walkway system .


Significant differences in the time factor for functional movement and gait ( P < @ ) were observed in the experimental and control groups .


For the group time interaction , significant improvements were observed in the functional movement ( Berg Balance Scale -LSB- @ vs. @ -RSB- , Timed Up and Go test -LSB- -@ vs. -@ secs -RSB- , and Stroke Rehabilitation Assessment of Movement scores -LSB- @ vs. @ -RSB- ) and gait ( velocity -LSB- @ vs. @ cm/sec -RSB- , cadence -LSB- @ vs. @ steps per minute -RSB- , paretic side step length -LSB- @ vs. @ cm -RSB- , and stride length -LSB- @ vs. @ cm -RSB- ) ( P < @ ) .


The findings of the current study demonstrated the efficacy of BWSTT with power-assisted functional electrical stimulation on the functional movement and gait ability in stroke patients .


Therefore , the authors suggest that power-assisted functional electrical stimulation may be an effective method for the improvement of functional movement and gait ability of stroke patients when added to BWSTT .


To determine the influence of non-surgical mechanical periodontal treatment on inflammatory markers related to risk for cardiovascular disease .


A total of @ patients with severe chronic periodontitis was randomly subjected to immediately periodontal treatment ( test group , n = @ ) or delayed periodontal treatment , without treatment during the study period ( control group , n = @ ) .


Clinical periodontal and laboratory examinations were performed at baseline ( T@ ) , @months ( T@ ) , and @months ( T@ ) after the initial examinations ( Control group ) or completion of periodontal treatment ( Test group ) .


After @months of periodontal treatment there was a significant reduction of erythrocyte sedimentation rate ( ESR ) and triglycerides ( p = @ , p = @ , respectively ) in the test group .


Median values of C-reactive protein , ESR , total cholesterol , and triglycerides were reduced after @month of periodontal treatment in the test group ( p < @ , p < @ , p < @ , and p = @ , respectively ) .


The non-surgical periodontal treatment was effective in reducing the levels of systemic inflammation markers and improved the lipid profile in subjects with severe chronic periodontitis .


Organ shortage limits the application of organ transplantation .


The attitudes of intensive care unit ( ICU ) staff play an important role in organ advocating .


The effects of an education program for ICU nurses on organ advocating were uncertain .


The purpose of this study was to explore the effects of an education program based on the Theory of Planned Behavior ( TPB ) on ICU nurses ' attitudes and behavioral intentions to advocate deceased organ donation .


Participants were recruited from @ different ICU units in medical centers and were randomly assigned to either an experimental group ( n = @ ) or a control group ( n = @ ) .


The nurses in the experimental group received comprehensive education programs , and the control groups received a brochure only .


The outcome parameters were measured by questionnaires at @ different time points of pretest , posttests immediately after education , and @ months later .


Before education , there was no difference in attitude and behavior intentions between the control and experimental groups .


After TPB training , the nurses significantly changed their attitudes and behavior intentions on organ advocating , both immediately ( P < @ ) and @ months after the education program ( P < @ ) .


In addition , multivariate analysis indicated that TPB training is significantly associated with the change of attitude ( P < @ ) and behavior intention ( P < @ ) of organ donation advocacy .


TPB education programs enhanced the ICU nurses ' attitudes and behavioral intentions on advocating organ donation .


Repeated education is advised to increase the participation of ICU nurses on organ advocacy .


To prospectively evaluate ovariectomy and ovariohysterectomy via midline coeliotomy when being employed by supervised final year veterinary students for the purpose of routine canine neutering .


One hundred and eight female dogs of various breeds , presented to a veterinary teaching hospital for neutering , were randomly allocated to one of two surgery groups , ovariectomy or ovariohysterectomy .


The specified procedure was performed by a supervised final year veterinary student .


If the duration of surgery exceeded @hours or if major surgical or anaesthetic complications occurred , the supervising surgeon intervened to complete the procedure .


Data analysed included age , weight , time from first incision to start of closure , duration of closure , total surgical time and length of incision .


Fifty-four dogs underwent each procedure .


There was no significant difference between the two surgery groups for any of the measured variables .


Ovariectomy is not associated with shorter surgical times or smaller abdominal incisions than ovariohysterectomy when employed by inexperienced surgeons .


As no major complications novel to ovariectomy occurred in this cohort of dogs , this study adds support to the existing literature indicating that ovariectomy is an acceptable alternative to ovariohysterectomy for canine neutering .


We previously showed that intramyocardial bone marrow cell ( BMC ) injection in patients with refractory angina and chronic myocardial ischemia improves myocardial perfusion , cardiac function and disease-related complaints .


Treatment effect varied between patients , but the predictors of response remain to be identified .


Therefore , the aim of the present study was to assess whether patient characteristics , procedural data and baseline measurements influence the response to intramyocardial BMC treatment in a large cohort of refractory angina patients .


In @ patients ( @ @ years , @ % men ) with refractory angina , @ @ @ ( @ ) BMCs were injected intramyocardially in regions with stress-inducible ischemia as assessed by single photon emission computed tomography ( SPECT ) .


Canadian Cardiovascular Society angina ( CCS ) class , quality-of-life score , exercise testing , SPECT and magnetic resonance imaging were performed at baseline and at @ months follow-up demonstrating significant improvements in CCS class , quality-of-life , exercise capacity , myocardial perfusion and left ventricular function ( all variables P < @ ) .


Multivariate analysis was performed to evaluate the influence of patient characteristics , procedural data and baseline measurements on BMC treatment response .


Based on the improvement of myocardial perfusion at stress , diabetes and a large number of ischemic segments at baseline were shown to be independently associated with a large response to BMC therapy .


The present study demonstrates that diabetes and a large number of ischemic segments are predictors of a large response to intramyocardial BMC injection in refractory angina and chronic ischemia .


Furthermore , the safety and efficacy results of previous trials are now confirmed in a larger study population .


We investigated the relationship between hypoxia , human papillomavirus ( HPV ) status and outcome in head and neck squamous cell carcinoma .


Patients with stage III and IV head and neck squamous cell carcinoma treated on phase I and II chemoradiation trials with @-Gy radiation combined with tirapazamine/cisplatin or cisplatin/fluorouracil ( @FU ) , hypoxic imaging using -LSB- @F -RSB- - misonidazole positron emission tomography and known HPV status ( by p@ immunohistochemistry ) were included in this sub-study .


Separate analyses were conducted to consider the impact of tirapazamine on HPV-negative tumours in the phase II trial .


Both p@-positive oropharyngeal tumours and p@-negative head and neck squamous cell carcinoma tumours had a high prevalence of tumour hypoxia ; @/@ ( @ % ) and @/@ ( @ % ) , respectively .


The distribution of hypoxia ( primary , nodal ) was similar .


On phase II , trial patients with p@-negative hypoxic tumours had worse loco-regional control with cisplatin and @FU compared with tirapazamine and cisplatin ( P < @ ) and worse failure-free survival ( hazard ratio = @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Only @ out of @ p@-positive patients on the phase II trial experienced loco-regional failure .


Hypoxia , as assessed by -LSB- @F -RSB- - misonidazole positron emission tomography , is frequently present in both p@-positive and negative head and neck cancer .


Further research is required to determine whether hypoxic imaging can be used to predict benefit from hypoxia-targeting therapies in patients with p@-negative tumours .


To observe the progression of labor when oxytocin use is limited to the onset of the active stage of labor .


A randomized , prospective controlled study was performed to address the issue of oxytocin infusion after the onset of active labor in @ patients .


In the study group , infusion of oxytocin was discontinued at the onset of the active phase of labor , which was accepted as a cervical dilatation of @ cm .


In the control group , incremental oxytocin infusion was administered until @ cm cervical dilatation , and then was maintained at the same level until delivery .


The primary outcome variable was duration from the beginning of the active phase to delivery .


In the study group , the duration of the active phase of labor was about @ min longer than in the control group and this difference was significant .


The secondary outcomes of the study were maternal-fetal complications of oxytocin and in both groups there were no significant differences .


It is not reasonable to discontinue oxytocin infusion at the beginning of active labor .


Nevertheless , for an accurate conclusion expanded investigations are needed .


To evaluate intestinal barrier function in neonates undergoing cardiac surgery using lactulose/mannitol ( L/M ) ratio measurements , and to determine correlations with early breast milk feeding .


This was a single-center , prospective , randomized pilot study of @ term-born neonates ( @ weeks gestation ) requiring cardiac surgery who were randomized to @ of @ preoperative feeding groups : nil per os ( NPO ) or trophic ( @ mL/kg/day ) breast milk feeds .


At @ time points ( preoperative -LSB- preop -RSB- , postoperative -LSB- postop -RSB- day @ , and postop day @ ) , subjects were administered an oral L/M solution , after which urine L/M ratios were measured using gas chromatography , with higher ratios indicative of increased intestinal permeability .


Trends over time in the mean urine L/M ratios for each group were estimated using a general linear mixed model .


There were no adverse events related to preoperative trophic feeding .


In the NPO group ( n = @ ) , the mean urine L/M ratio was @ at preop , @ at postop day @ , and @ at postop day @ .


In the trophic breast milk feeds group ( n = @ ) , the mean urine L/M ratio was @ at preop , @ at postop day @ , and @ at postop day @ .


In both groups , L/M ratios were significantly higher at postop day @ and postop day @ compared with preop ( P < @ ) .


Neonates have increased intestinal permeability after cardiac surgery extending to at least postop day @ .


This pilot study was not powered to detect differences in benefit or adverse events comparing the NPO and trophic breast milk feeds groups .


Further studies to identify mechanisms of intestinal injury and therapeutic interventions are warranted .


Serum procalcitonin is commonly used to differentiate systemic inflammation due to infection from non-infectious causes .


Limited data exist on the value of procalcitonin in predicting relative adrenal insufficiency ( RAI ) .


This study evaluated the value of procalcitonin in predicting RAI and mortality in cirrhotic patients with septic shock .


This was a post-hoc analysis of a randomized placebo-controlled trial that evaluated low-dose hydrocortisone in cirrhotic patients with septic shock .


Extracted first study-day data included serum procalcitonin , baseline serum cortisol , cortisol level after @ microg - adrenocorticotropic hormone stimulation test and @ - day mortality .


RAI was defined as a baseline serum cortisol < @ microg/dL or cortisol not rising by > @ microg/dL after stimulation .


Procalcitonin > @ ng/mL was considered high .


Forty-five patients had serum procalcitonin measured ( mean = @ + / - @ ng/mL , first and third quartiles were @ and @ ng/mL , respectively ) .


Most ( @ % ) patients had high procalcitonin levels .


RAI was present in @ ( @ % ) patients .


Patients with high procalcitonin were more likely to have RAI ( odds ratio , @ ; @ % confidence interval , @ - @ ) .


Receiver operator characteristic curve analysis showed that the best cut-off for detecting RAI was @ ng/mL ( sensitivity = @ % and specificity = @ % ) .


High serum procalcitonin was not associated with @ - day mortality ( @ % for normal procalcitonin and @ % for high procalcitonin , p = @ ) .


High serum procalcitonin was highly associated with RAI in cirrhotic patients with septic shock .


Procalcitonin was not associated with @ - day mortality in this patient population .


The efficacy and safety of insulin degludec ( IDeg ) was compared with insulin detemir ( IDet ) , both administered once daily ( OD ) as basal treatment in participants with type @ diabetes mellitus ( T@DM ) .


The primary outcome was non-inferiority of IDeg to IDet in glycated haemoglobin ( HbA@c ) reduction after @ weeks .


This multinational , @-week , controlled , open-label , parallel-group trial randomized adults with T@DM to IDeg or IDet as OD basal insulin treatment combined with mealtime bolus insulin aspart ( IAsp ) .


Participants with T@DM treated with any basal-bolus insulin regimen for @ months prior to the trial , a mean HbA@c @ % ( @ mmol/mol ) and body mass index ( BMI ) @ kg/m ( @ ) at screening participated in the trial ( IDeg : N = @ ; IDet : N = @ ) .


After @ weeks , HbA@c decreased @ % ( @ mmol/mol ) ( IDeg ) and @ % ( @ mmol/mol ) ( IDet ) -LSB- estimated treatment difference ( ETD ) IDeg-IDet : -@ % ( -@ ; @ ) @ % CI ( -@ mmol/mol -LSB- -@ ; @ -RSB- @ % CI ) ; confirming non-inferiority -RSB- .


Mean fasting plasma glucose improved in both groups , and was lower with IDeg than IDet -LSB- ETD IDeg-IDet : -@ mmol/l ( -@ ; -@ ) @ % CI , p < @ -RSB- .


The rate of confirmed hypoglycaemia was similar with IDeg and IDet -LSB- @ vs. @ episodes per patient-year of exposure ( PYE ) ; estimated rate ratio ( RR ) IDeg/IDet : @ ( @ ; @ ) @ % CI , p = @ -RSB- .


The rate of nocturnal confirmed hypoglycaemia was lower with IDeg than IDet -LSB- @ vs. @ episodes per PYE ; RR IDeg/IDet : @ ( @ ; @ ) @ % CI , p = @ -RSB- .


Adverse event profiles were similar between groups .


IDeg administered OD in basal-bolus therapy effectively improved long-term glycaemic control in participants with T@DM with a lower risk of nocturnal confirmed hypoglycaemia than IDet .


Human growth hormone ( hGH ) replacement therapy currently requires daily sc injections for years/lifetime , which may be both inconvenient and distressing for patients .


NNC@-@ is a novel hGH derivative intended for once-weekly treatment of GH deficiency .


A noncovalent albumin binding moiety is attached to the hGH backbone .


Clearance is reduced as a consequence of a reversible binding to circulating serum albumin , which prolongs the pharmacodynamic ( PD ) effect .


To evaluate safety , local tolerability , pharmacokinetics ( PK ) , and pharmacodynamics ( PD ) of a single dose ( SD ) and multiple doses ( MD ) of NNC@-@ .


Randomized , single-center , placebo-controlled , double-blind , SD/MD , dose-escalation trial of @ healthy male subjects .


NNC@-@ sc administration : Five cohorts of eight subjects received one dose of NNC@-@ ( @-@ @ mg/kg ) ( n = @ ) or placebo ( n = @ ) .


Sixteen subjects ( equal numbers of Japanese and non-Asian ) received once-weekly doses of NNC@-@ ( @-@ @ mg/kg ; n = @ ) or placebo ( n = @ ) for @ weeks .


Blood samples were drawn for assessment of safety , PK , IGF-@ , and IGF binding protein @ profiles and anti-drug antibodies .


SD and MD of NNC@-@ were well tolerated at all dose levels .


No safety concerns or local tolerability issues were identified .


A dose-dependent IGF-@ response was observed .


IGF-@ profiles suggest that NNC@-@ may be suitable for once-weekly dosing , with a clinically relevant dose @ mg/kg/week .


No differences in PK and PD were observed between Japanese and non-Asian subjects .


SD and MD of NNC@-@ administered to healthy Japanese and non-Asian male subjects were well tolerated at all doses .


The present trial suggests that NNC@-@ has the potential for an efficacious , well-tolerated , once-weekly GH treatment .


To compare long-term outcomes following microwave endometrial ablation ( MEA ) and thermal balloon ablation ( TBall ) .


Follow up of a prospective , double-blind randomised controlled trial at @years .


A teaching hospital in the UK .


A total of @ women eligible for and requesting endometrial ablation .


Eligible women were randomised in a @:@ ratio to undergo MEA or Tball .


Postal questionnaires were sent to participants at a minimum of @years postoperatively to determine satisfaction with outcome , menstrual status , bleeding scores and quality of life measurement .


Subsequent surgery was ascertained from the women and the hospital operative database .


The primary outcome measure was overall satisfaction with treatment .


Secondary outcomes included evaluation of menstrual loss , change in quality of life scores and subsequent surgery .


Of the women originally randomised @/@ ( @ % ) returned questionnaires .


Nonresponders were assumed to be treatment failures for data analysis .


The primary outcome of satisfaction was similar in both groups ( @ % for MEA versus @ % for TBall , difference @ % ; @ % CI -@ to @ % ) .


Amenorrhoea rates were high following both techniques ( @ % versus @ % , difference @ % ; @ % CI -@ to @ % ) .


There was no significant difference in the hysterectomy rates between the two arms ( @ % versus @ % , difference @ % ; @ % CI -@ to @ % ) .


At @years post-treatment there were no significant clinical differences in patient satisfaction , menstrual status , quality of life scores or hysterectomy rates between MEA and Thermachoice @ , thermal balloon ablation .


Obesity at diagnosis is associated with poor prognosis in women with breast cancer , but few reports have been adjusted for treatment factors .


CALGB @ was a randomized trial of dose density and sequence of chemotherapy for node-positive breast cancer .


All patients received doxorubicin , cyclophosphamide , and paclitaxel , dosed by actual body weight .


Height and weight at diagnosis were abstracted from patient records , and the PAM@ assay was performed from archived specimens using the NanoString platform .


Relationships between body mass index ( BMI ) , PAM@ , and recurrence-free and overall survival ( RFS and OS ) were evaluated using proportional hazards regression , adjusting for number of involved nodes , estrogen receptor ( ER ) status , tumor size , menopausal status , drug sequence , and dose density .


All statistical tests were two-sided .


Baseline height and weight were available for @ of @ enrolled patients ; @ additionally had subtype determination by PAM@ .


Median baseline BMI was @ kg/m ( @ ) .


After @ years of median follow-up , there were @ RFS events and @ deaths .


Baseline BMI was a statistically significant predictor of RFS ( adjusted hazard ratio -LSB- HR -RSB- for each five-unit increase in BMI = @ , @ % confidence interval -LSB- CI -RSB- = @ to @ , P = @ ) and OS ( adjusted HR = @ , @ % CI = @ to @ , P = @ ) BMI and molecular phenotypes were independent prognostic factors for RFS , with no statistically significant interactions detected .


BMI at diagnosis was a statistically significant prognostic factor in a group of patients receiving optimally dosed chemotherapy .


Additional research is needed to determine the impact of weight loss on breast cancer outcomes and to evaluate whether this impact is maintained across tumor subtypes .


Disodium ethylenediaminetetraacetic acid ( EDTA ) reduced adverse cardiac outcomes in a factorial trial also testing oral vitamins .


This report describes the intent-to-treat comparison of the @ factorial groups overall and in patients with diabetes .


This was a double-blind , placebo-controlled , @ @ factorial multicenter randomized trial of @,@ post-myocardial infarction ( MI ) patients @ years of age and with creatinine @ mg/dL randomized to receive @ EDTA chelation or placebo infusions plus @ caplets daily of a @-component multivitamin-multimineral mixture or placebo .


The primary end point was a composite of total mortality , MI , stroke , coronary revascularization , or hospitalization for angina .


Median age was @ years , @ % were female , @ % were Caucasian , @ % were diabetic , @ % had prior coronary revascularization , and @ % were on statins .


Five-year Kaplan-Meier estimates for the primary end point was @ % in the chelation + high-dose vitamin group , @ % in the chelation + placebo vitamin group , @ % in the placebo infusion + active vitamin group , and @ % in the placebo infusions + placebo vitamin group .


The reduction in primary end point by double active treatment compared with double placebo was significant ( hazard ratio @ , @ % CI @-@ @ , P = @ ) .


In patients with diabetes , the primary end point reduction of double active compared with double placebo was more pronounced ( hazard ratio @ , @ % CI @-@ @ , P < @ ) .


In stable post-MI patients on evidence-based medical therapy , the combination of oral high-dose vitamins and chelation therapy compared with double placebo reduced clinically important cardiovascular events to an extent that was both statistically significant and of potential clinical relevance .


Benefit from antidepressant treatment such as selective serotonin reuptake inhibitors ( SSRIs ) may depend on individual differences in acute effects on neural emotion processing .


The short ( 'S ' ) allele of the serotonin transporter ( @-HTT ) - linked polymorphic region ( @-HTTLPR ) is associated with both negative emotion processing biases and poorer treatment outcomes .


Therefore , the aim of the present study was to explore the effects of @-HTTLPR on the impact of the SSRI escitalopram during processing of positive and negative emotional images , as well as neutral stimuli .


The study employed a double-blind , randomised , placebo-controlled crossover design on @ healthy Caucasian female participants who underwent functional magnetic resonance imaging ( fMRI ) scanning following placebo or escitalopram treatment , separated by a @-day washout period .


Changes in the left amygdala signal with escitalopram treatment during processing of emotional stimuli were linearly related to the @-HTTLPR 'S ' allele load such that the signal to positive stimuli decreased and the signal to negative stimuli increased with an increasing number of low-expressing 'S ' alleles .


While @-HTTLPR subgroups were small in size , individual subject changes with treatment and task condition increase confidence in the findings .


While preliminary , our findings comprise the first pharmacogenetic study demonstrating an effect of the @-HTTLPR 'S ' allele load on escitalopram-induced changes in amygdala activity during emotional processing , consistent with a @-HTT expression dosage model .


The present findings have implications for the impact of this polymorphism on antidepressant efficacy in patients with mood and anxiety disorders .


As compared with a standard-dose vaccine , a high-dose , trivalent , inactivated influenza vaccine ( IIV@-HD ) improves antibody responses to influenza among adults @ years of age or older .


This study evaluated whether IIV@-HD also improves protection against laboratory-confirmed influenza illness .


We conducted a phase IIIb-IV , multicenter , randomized , double-blind , active-controlled trial to compare IIV@-HD ( @ g of hemagglutinin per strain ) with standard-dose trivalent , inactivated influenza vaccine ( IIV@-SD -LSB- @ g of hemagglutinin per strain -RSB- ) in adults @ years of age or older .


Assessments of relative efficacy , effectiveness , safety ( serious adverse events ) , and immunogenicity ( hemagglutination-inhibition -LSB- HAI -RSB- titers ) were performed during the @-@ ( year @ ) and the @-@ ( year @ ) northern-hemisphere influenza seasons .


A total of @,@ participants were enrolled from @ research centers in the United States and Canada ( @,@ were randomly assigned to receive IIV@-HD , and @,@ to receive IIV@-SD ) .


In the intention-to-treat analysis , @ participants in the IIV@-HD group ( @ % ) and @ participants in the IIV@-SD group ( @ % ) had laboratory-confirmed influenza caused by any viral type or subtype associated with a protocol-defined influenza-like illness ( relative efficacy , @ % ; @ % confidence interval -LSB- CI -RSB- , @ to @ ) .


At least one serious adverse event during the safety surveillance period was reported by @ ( @ % ) of the participants in the IIV@-HD group , as compared with @ ( @ % ) of the participants in the IIV@-SD group ( relative risk , @ ; @ % CI , @ to @ ) .


After vaccination , HAI titers and seroprotection rates ( the percentage of participants with HAI titers @:@ ) were significantly higher in the IIV@-HD group .


Conclusions : Among persons @ years of age or older , IIV@-HD induced significantly higher antibody responses and provided better protection against laboratory-confirmed influenza illness than did IIV@-SD .


( Funded by Sanofi Pasteur ; ClinicalTrials.gov number , NCT@ . )


Increasing numbers of reports show the beneficial effects of listening to Mozart music in decreasing epileptiform discharges as well as seizure frequency in epileptic children .


There has been no effective method to reduce seizure recurrence after the first unprovoked seizure until now .


In this study , we investigated the effect of listening to Mozart K. @ in reducing the seizure recurrence rate in children with first unprovoked seizures .


Forty-eight children who experienced their first unprovoked seizure with epileptiform discharges were included in the study .


They were randomly placed into treatment ( n = @ ) and control ( n = @ ) groups .


Children in the treatment group listened to Mozart K. @ daily before bedtime for at least six months .


Two patients in the treatment group were excluded from analysis due to discontinuation intervention .


Finally , forty-six patients were analyzed .


Most of these patients ( @ % ) were idiopathic in etiology .


Seizure recurrence rates and reduction of epileptiform discharges were compared .


The average follow-up durations in the treatment and control groups were @ @ and @ @ months , respectively .


The seizure recurrence rate was estimated to be significantly lower in the treatment group than the control group over @ months ( @ % vs. @ % , p = @ ) .


Significant decreases in epileptiform discharges were also observed after @ , @ , and @ months of listening to Mozart K. @ when compared with EEGs before listening to music .


There were no significant differences in gender , mentality , seizure type , and etiology between the recurrence and non-recurrence groups .


Although the case number was limited and control music was not performed in this study , the study revealed that listening to Mozart K. @ reduced the seizure recurrence rate and epileptiform discharges in children with first unprovoked seizures , especially of idiopathic etiology .


We believe that Mozart K. @ could be a promising alternative treatment in patients with first unprovoked seizures and abnormal EEGs .


Further large-scaled study should be conducted to confirm the effect .


Better diet quality has been associated with less weight gain over time .


However , few studies have examined the role of diet quality during weight loss .


This study aimed to compare changes in diet quality in overweight/obese adults during a weight loss intervention , and determine whether an association between diet quality score and weight loss exists .


Overweight or obese ( BMI @-@kg / m@ ) adults , aged @-@ years , were recruited from the Hunter Region of NSW , Australia and randomized to one of three groups : a standard online weight loss program ( n = @ ) ; an enhanced version of this online program that provided additional personalized feedback and reminders ( n = @ ) ; or a wait-list control group ( n = @ ) .


Diet quality was calculated using the Australian Recommended Food Score ( ARFS ) with dietary data from the Australian Eating Survey ( AES ) Food Frequency Questionnaire at baseline and @-weeks .


The basic and enhanced groups lost significantly more weight than the control group after @weeks ( basic -@ kg , enhanced -@ kg , control @ kg , P < @ ) with no difference between the basic and enhanced groups .


The mean change in ARFS in the enhanced group ( @ ) was significantly higher ( P = @ ) than the control group .


There were no significant differences in change in ARFS between the enhanced and basic , or basic and control groups .


The ARFS and the fruit , meat , wholegrain , dairy and water sub-scale scores at @weeks were significantly associated with greater weight loss ( P < @ ) .


Diet quality improved significantly in the enhanced group compared to controls following @-weeks intervention .


Furthermore , higher diet quality was associated with greater weight loss .


To examine the effects of @ weeks of high-speed resistance training ( RT ) versus low-speed RT on muscle strength -LSB- one repetition of maximum leg-press ( @RMLP ) and bench-press ( @RMBP ) , plus dominant ( HGd ) and non-dominant maximum isometric handgrip -RSB- , power -LSB- counter-movement jump ( CMJ ) , ball throwing ( BT ) and @-m walking sprint ( S@ ) -RSB- , functional performance -LSB- @-foot up-and-go test ( UG ) and sit-to-stand test ( STS ) -RSB- , and perceived quality of life in older women .


@ older women were divided into a high-speed RT group -LSB- EG , n = @ , age = @ y -RSB- , a low-speed RT group -LSB- SG , n = @ , age = @ y -RSB- and a control group -LSB- CG , n = @ , age = @ y -RSB- .


The SG and EG were submitted to a similar @-week RT program -LSB- @ sets of @ reps at @-@ % of the one-repetition maximum ( @ < RM ) , CMJ and BT -RSB- using slow , controlled ( @s ) concentric muscle actions for the SG and using fast , explosive ( < @s ) concentric muscle actions for the EG ( @ % less work per exercise without CMJ and BT ) .


Over the @-week training period , both RT groups showed small to large clinically significant improvements in the dependent variables ; however , a significant difference was found between the EG and SG for the performance changes in BT , S@ and UG ( @ % vs. @ % , p < @ ; @ % vs. @ % , p < @ ; @ % vs. @ % , p < @ ; respectively ) .


No significant changes were observed for the CG .


Both RT interventions are effective in improving functional capacity , muscle performance and quality of life in older women , although a high-speed RT program induces greater improvements in muscle power and functional capacity .


Multiple health behavior change can ameliorate adverse effects of cancer .


The purpose of this study was to determine the effects of a multiple health behavior change intervention ( CanChange ) for colorectal cancer survivors on psychosocial outcomes and quality of life .


A total of @ colorectal cancer survivors were randomized to a @-month telephone-based health coaching intervention ( @ sessions using acceptance and commitment therapy strategies focusing on physical activity , weight management , diet , alcohol , and smoking ) or usual care .


Posttraumatic growth , spirituality , acceptance , mindfulness , distress , and quality of life were assessed at baseline , @ and @months .


Significant intervention effects were observed for posttraumatic growth at @ ( @ , p < @ ) and @months ( @ , p = @ ) , spirituality at @months ( @ , p = @ ) , acceptance at @months ( @ , p = @ ) , and quality of life at @ ( @ , p = @ ) and @months ( @ , p = @ ) .


The intervention improved psychosocial outcomes and quality of life ( physical well-being ) at @months with most effects still present at @months .


The combined inhibition of BRAF and MEK is hypothesized to improve clinical outcomes in patients with melanoma by preventing or delaying the onset of resistance observed with BRAF inhibitors alone .


This randomized phase @ study evaluated the combination of the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib .


We randomly assigned @ patients with previously untreated unresectable locally advanced or metastatic BRAF V@ mutation-positive melanoma to receive vemurafenib and cobimetinib ( combination group ) or vemurafenib and placebo ( control group ) .


The primary end point was investigator-assessed progression-free survival .


The median progression-free survival was @ months in the combination group and @ months in the control group ( hazard ratio for death or disease progression , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P < @ ) .


The rate of complete or partial response in the combination group was @ % , as compared with @ % in the control group ( P < @ ) , including rates of complete response of @ % in the combination group and @ % in the control group .


Progression-free survival as assessed by independent review was similar to investigator-assessed progression-free survival .


Interim analyses of overall survival showed @-month survival rates of @ % ( @ % CI , @ to @ ) in the combination group and @ % ( @ % CI , @ to @ ) in the control group .


Vemurafenib and cobimetinib was associated with a nonsignificantly higher incidence of adverse events of grade @ or higher , as compared with vemurafenib and placebo ( @ % vs. @ % ) , and there was no significant difference in the rate of study-drug discontinuation .


The number of secondary cutaneous cancers decreased with the combination therapy .


The addition of cobimetinib to vemurafenib was associated with a significant improvement in progression-free survival among patients with BRAF V@-mutated metastatic melanoma , at the cost of some increase in toxicity .


( Funded by F. Hoffmann-La Roche/Genentech ; coBRIM ClinicalTrials.gov number , NCT@ . )


This retrospective study assessed whether dual-source high-pitch computed tomographic angiography ( CTA ) offered advantages over single-source standard-pitch techniques in the evaluation of the ascending aorta .


Twenty patients who received both thoracic dual-source high-pitch and single-source standard-pitch CTAs within @ year were assessed .


Dual-source CTAs were performed ; standard-pitch imaging used dose-modulated @ kVp/@ mAs and @ pitch compared with high-pitch protocols employing dose-modulated @ kVp/@ mAs and @ target pitch .


Radiation dose was documented .


Contrast-to-noise ratios ( CNRs ) at sinuses of the Valsalva ( CNRValsalva ) and ascending aorta ( CNRAorta ) were calculated .


Dose/CNR for each technique was compared with paired t-tests .


Motion at aortic valve , aortic root and ascending aorta were assessed with four-point scales and Mann-Whitney U tests ; longitudinal extension of motion was compared with paired t-tests .


Significantly lower motion scores for high-pitch , compared with standard-pitch acquisitions for aortic annulus , @ vs. @ , aortic root , @ vs. @ , and ascending aorta , @ vs. @ , were achieved .


Significantly reduced longitudinal extension of motion at aortic root , @ mm vs @ mm , and ascending aorta , @ mm vs @ mm , was observed .


Contrast was not impacted : CNRValsalva , @ vs @ , and CNRAorta , @ vs @ .


CTDIvol was significantly decreased for high-pitch acquisitions , @ mGy vs @ mGy .


Dual-source high-pitch CTAs significantly decreased motion artefact without negatively impacting vascular contrast and radiation dose .


Dual-source high-pitch CTA significantly decreased motion artefact of the ascending aorta .


Dual-source high-pitch CTA did not negatively impact on vascular contrast .


Dual-source high-pitch CTA significantly decreased radiation dose compared with single-source standard-pitch acquisitions .


To compare usual diabetes care ( UDC ) to a comprehensive diabetes care intervention condition ( IC ) involving an Internet-based `` diabetes dashboard '' management tool used by clinicians .


We used a parallel-group randomized design .


Diabetes nurses , diabetes dietitians , and providers used the diabetes dashboard as a clinical decision support system to deliver a five-visit , @-month intervention to @ poorly controlled ( HbA@c > @ % -LSB- @ mmol/mol -RSB- ) Latino type @ diabetic ( T@D ) patients ( mean age @ years , @ % female ) at urban community health centers .


We compared this intervention to an established , in-house UDC program ( n = @ ) for its impact on blood glucose control and psychosocial outcomes .


Recruitment and retention rates were @ and @ % , respectively .


Compared with UDC , more IC patients reached HbA@c targets of < @ % ( @ mmol/mol ; @ vs. @ % , respectively , P < @ ) and < @ % ( @ mmol/mol ; @ vs. @ % , respectively , P < @ ) .


In multiple linear regression adjusting for baseline HbA@c , adjusted mean SE HbA@c at follow-up was significantly lower in the IC compared with the UDC group ( P < @ ; IC @ @ % ; UDC @ @ % ) .


The results showed lower diabetes distress at follow-up for IC patients ( @ @ ) as compared with UDC patients ( @ @ ) ( P < @ ) , and also lower social distress ( @ @ vs. @ @ , P < @ ) .


There was a similar , statistically significant ( P < @ ) improvement for both groups in the proportion of patients moving from depressed status at baseline to nondepressed at follow-up ( @ vs. @ % ; no significance between groups ) .


The diabetes dashboard intervention significantly improved diabetes-related outcomes among Latinos with poorly controlled T@D compared with a similar diabetes team condition without access to the diabetes dashboard .


Risk factors for acquired rifampicin resistance ( ARR ) in human immunodeficiency virus ( HIV ) / tuberculosis coinfection , in the highly active antiretroviral therapy ( HAART ) era , needs evaluation .


We studied the impact of HIV and HAART on ARR among patients taking thrice-weekly antituberculosis therapy .


This cross-protocol analysis included patients with newly diagnosed , rifampicin-susceptible pulmonary tuberculosis , with and without HIV , enrolled in clinical trials ( who took > @ % of medication ) at the National Institute for Research in Tuberculosis between @ and @ .


All patients received rifampicin and isoniazid for @ months reinforced with pyrazinamide and ethambutol in the first @ months , given thrice-weekly throughout the study along with HAART in one of the groups .


Outcomes were categorized and multivariate logistic regression analysis performed to identify risk factors for ARR .


The per-protocol results included patients with tuberculosis : @ HIV-uninfected patients ( HIV ( - ) TB ( + ) ) , @ HIV patients not on HAART ( non-HAART ) , and @ HIV-infected patients on HAART .


Median CD@ counts of the latter @ groups were @ and @ cells/L , respectively , and the median viral loads were @ @ and @ @ copies/mL , respectively .


Compared with HIV ( - ) TB ( + ) , the relative risks ( RRs ) for an unfavorable response in the coinfected , non-HAART and HAART groups were @ ( @ % confidence interval -LSB- CI -RSB- , @-@ @ ; P < @ ) and @ ( @ % CI , @ -@ ; P = @ ) , whereas for ARR , the RRs were @ ( @ % CI , @-@ ; P < @ ) and @ ( @ % CI , @ -@ ; P = @ ) , respectively .


HIV-infected patients with tuberculosis treated with a thrice-weekly antituberculosis regimen are at a higher risk of ARR , compared with HIV-uninfected patients , in the presence of baseline isoniazid resistance .


HAART reduces but does not eliminate the risk of ARR .


Poor governance and accountability compromise young democracies ' efforts to provide public services critical for human development , including water , sanitation , health , and education .


Evidence shows that accountability agencies like superior audit institutions can reduce corruption and waste in federal grant programs financing service infrastructure .


However , little is know about their effect on compliance with grant reporting and resource allocation requirements , or about the causal mechanisms .


This study protocol for an exploratory randomized controlled trial tests the hypothesis that federal and state audits increase compliance with a federal grant program to improve municipal service infrastructure serving marginalized households .


The AUDIT study is a block randomized , controlled , three-arm parallel group exploratory trial .


A convenience sample of @ municipalities in each of @ states in Mexico ( n = @ ) were block randomized to be audited by federal auditors ( n = @ ) , by state auditors ( n = @ ) , and a control condition outside the annual program of audits ( n = @ ) in a @:@:@ ratio .


Replicable and verifiable randomization was performed using publicly available lottery numbers .


Audited municipalities were included in the national program of audits and received standard audits on their use of federal public service infrastructure grants .


Municipalities receiving moderate levels of grant transfers were recruited , as these were outside the auditing sampling frame -- and hence audit program -- or had negligible probabilities of ever being audited .


The primary outcome measures capture compliance with the grant program and markers for the causal mechanisms , including deterrence and information effects .


Secondary outcome measure include differences in audit reports across federal and state auditors , and measures like career concerns , political promotions , and political clientelism capturing synergistic effects with municipal accountability systems .


The survey firm and research assistants assessing outcomes were blind to treatment status .


This study will improve our understanding of local accountability systems for public service delivery in the @ states under study , and may have downstream policy implications .


The study design also demonstrates the use of verifiable and replicable randomization , and of sequentially partitioned hypotheses to reduce the Type I error rate in multiple hypothesis tests .


Since the @ inception of universal childhood influenza vaccination , national rates have risen more dramatically among younger children than older children and reported rates across racial/ethnic groups are inconsistent .


Interventions may be needed to address age and racial disparities to achieve the recommended childhood influenza vaccination target of @ % .


To evaluate an intervention to increase childhood influenza vaccination across age and racial groups .


In @-@ , a total of @ primary care practices treating children were randomly assigned to the intervention and control arms of a cluster randomized controlled trial to increase childhood influenza vaccination uptake using a toolkit and other strategies including early delivery of donated vaccine , in-service staff meetings , and publicity .


The average vaccination differences from pre-intervention to the intervention year were significantly larger in the intervention arm ( n = @ practices ) than the control arm ( n = @ practices ) ; for children aged @-@ years ( @ pct pts intervention vs @ pct pts control , p < @ ) ; for non-white children ( @ pct pts intervention vs @ pct pts control , p < @ ) ; and overall ( @ pct pts intervention vs @ pct pts control , p < @ ) .


In multi-level modeling that accounted for person - and practice-level variables and the interactions among age , race , and intervention , the likelihood of vaccination increased with younger age group ( @-@ months ) ; white race ; commercial insurance ; the practice 's pre-intervention vaccination rate ; and being in the intervention arm .


Estimates of the interaction terms indicated that the intervention increased the likelihood of vaccination for non-white children in all age groups and white children aged @-@ years .


A multi-strategy intervention that includes a practice improvement toolkit can significantly improve influenza vaccination uptake across age and racial groups without targeting specific groups , especially in practices with large percentages of minority children .


Little evidence exists on which exercise modality is optimal for obese adolescents .


To determine the effects of aerobic training , resistance training , and combined training on percentage body fat in overweight and obese adolescents .


Randomized , parallel-group clinical trial at community-based exercise facilities in Ottawa ( Ontario ) and Gatineau ( Quebec ) , Canada , among previously inactive postpubertal adolescents aged @ to @ years ( Tanner stage IV or V ) with body mass index at or above the @th percentile for age and sex or at or above the @th percentile plus an additional diabetes mellitus or cardiovascular risk factor .


After a @-week run-in period , @ participants were randomized to the following @ groups for @ weeks : aerobic training ( n = @ ) , resistance training ( n = @ ) , combined aerobic and resistance training ( n = @ ) , or nonexercising control ( n = @ ) .


All participants received dietary counseling , with a daily energy deficit of @ kcal .


The primary outcome was percentage body fat measured by magnetic resonance imaging at baseline and @ months .


We hypothesized that aerobic training and resistance training would each yield greater decreases than the control and that combined training would cause greater decreases than aerobic or resistance training alone .


Decreases in percentage body fat were -@ ( @ % CI , -@ to @ ) in the control group , -@ ( @ % CI , -@ to -@ ) in the aerobic training group ( P = @ vs controls ) , and -@ ( @ % CI , -@ to -@ ) in the resistance training group ( P = @ vs controls ) .


The -@ ( @ % CI , -@ to -@ ) decrease in the combined training group did not differ significantly from that in the aerobic or resistance training group .


Waist circumference changes were -@ ( @ % CI , -@ to @ ) cm in the control group , -@ ( @ % CI , -@ to -@ ) cm in the aerobic group ( P = @ vs controls ) , -@ ( @ % CI -@ to -@ ) cm in the resistance training group ( P = @ vs controls ) , and -@ ( @ % CI , -@ to -@ ) cm in the combined training group .


In per-protocol analyses ( @ % adherence ) , the combined training group had greater changes in percentage body fat ( -@ , @ % CI , -@ to -@ ) vs the aerobic group ( -@ ; @ % CI , -@ to -@ ; P = @ vs the combined group ) but not the resistance group ( -@ ; @ % CI , -@ to -@ ) .


Aerobic , resistance , and combined training reduced total body fat and waist circumference in obese adolescents .


In more adherent participants , combined training may cause greater decreases than aerobic or resistance training alone .


To assess the safety and efficacy of combining oncolytic adenovirus-mediated cytotoxic gene therapy ( OAMCGT ) with intensity modulated radiation therapy ( IMRT ) in intermediate-risk prostate cancer .


Forty-four men with intermediate-risk prostate cancer were randomly assigned to receive either OAMCGT plus IMRT ( arm @ ; n = @ ) or IMRT only ( arm @ ; n = @ ) .


The primary phase @ endpoint was acute ( @ days ) toxicity .


Secondary endpoints included quality of life ( QOL ) , prostate biopsy ( @-core ) positivity at @ years , freedom from biochemical/clinical failure ( FFF ) , freedom from metastases , and survival .


Men in arm @ exhibited a greater incidence of low-grade influenza-like symptoms , transaminitis , neutropenia , and thrombocytopenia than men in arm @ .


There were no significant differences in gastrointestinal or genitourinary events or QOL between the @ arms .


Two-year prostate biopsies were obtained from @ men ( @ % ) .


Thirty-three percent of men in arm @ were biopsy-positive versus @ % in arm @ , representing a @ % relative reduction in biopsy positivity in the investigational arm ( P = @ ) .


There was a @ % relative reduction in biopsy positivity in the investigational arm in men with < @ % positive biopsy cores at baseline ( P = @ ) .


To date , @ patient in each arm exhibited biochemical failure ( arm @ , @ % ; arm @ , @ % ) .


No patient developed hormone-refractory or metastatic disease , and none has died from prostate cancer .


Combining OAMCGT with IMRT does not exacerbate the most common side effects of prostate radiation therapy and suggests a clinically meaningful reduction in positive biopsy results at @ years in men with intermediate-risk prostate cancer .


Medication reconciliation improves congruence in cross sectional patient courses .


Our regional electronic medical record ( EMR ) integrates the shared medication record ( SMR ) which provides full access to current medication and medication prescriptions for all citizens in Denmark .


We studied whether our SMR integration could facilitate medication reconciliation .


Patients admitted to the emergency department for hospitalization were randomised to consultation using EMR with or without the integrated SMR access .


Observed time used for medication reconciliation was the primary efficacy parameter .


A total of @ consecutive patient consultations were randomised including @ with more than five prescriptions .


EMR had data from previous consultations for @ patients , @ patients provided information on medication .


In all , @ junior physicians in early postgraduate medical training each participated with a median of three consultations ( range @-@ ) .


Time expenditure for medicine reconciliation was @:@ min. : sec .


( range : @:@ -@:@ ) with access to SMR integration and @:@ min. : sec .


( @:@ -@:@ ) without SMR access .


The number of active medicine prescriptions was eight and nine , respectively .


Incorporating SMR did not increase the work load .


Physicians judged the SMR integration and workflow as being useful .


Patients unambiguously sup-ported physicians ' use of SMR in this setting .


Integration of information on individuals ' medication from a national SMR into a hospital EMR was feasible and useful , and it did not increase time expenditure for medication reconciliation .


Pegfilgrastim is a pegylated form of filgrastim , a recombinant protein of granulocyte colony-stimulating factor , that is used to reduce the risk of febrile neutropenia ( FN ) .


Here , we report the results of a phase III trial of pegfilgrastim in breast cancer patients receiving docetaxel and cyclophosphamide ( TC ) chemotherapy .


We conducted a double-blind , placebo-controlled , randomized trial to determine the efficacy of pegfilgrastim in reducing the risk of FN in early-stage breast cancer patients .


A total of @ women ( @ in the pegfilgrastim group and @ in the placebo group ) between @ and @ years of age with stage I-III invasive breast carcinoma who were to receive TC chemotherapy ( docetaxel @ mg/m ( @ ) and cyclophosphamide @ mg/m ( @ ) every @ weeks ) as either neoadjuvant or adjuvant therapy were enrolled ; @ of these patients were treated with either pegfilgrastim ( n = @ ) or placebo ( n = @ ) .


The incidence of FN was significantly lower in the pegfilgrastim group than in the placebo group ( @ vs. @ % , respectively ; P < @ ) .


In addition , patients in the pegfilgrastim group required less hospitalization and antibiotics for FN .


Most adverse events were consistent with those expected for breast cancer subjects receiving TC chemotherapy .


Pegfilgrastim is safe and significantly reduces the incidence of FN in breast cancer patients .


Cerebral palsy ( CP ) is a disabling condition characterized by the motor impairment , which is difficult to be ameliorated .


In the brain of infants with CP , there are persistent pathomechanisms including accentuated neuroinflammation .


Since erythropoietin was demonstrated to have neuroprotective effect via anti-inflammatory and anti-apoptotic properties , we hypothesized that the administration of recombinant human EPO ( rhEPO ) could help children with CP , especially young infants .


We investigated the therapeutic efficacy of rhEPO for infants with CP , who had been undergoing active rehabilitation in hospitalized setting to eliminate treatment bias .


Twenty infants with CP were randomly divided into EPO or control group equally .


We compared the changes in the Gross Motor Function Measure ( GMFM ) and the Bayley Scales of Infant Development-II ( BSID-II ) scores during one month of hospitalization between two groups .


The improvements after @ month on the GMFM A and GMFM total scores differed significantly between the groups ( p = @ , p = @ , respectively ) .


However , the changes after @ months were not different between the two groups .


The scores of BSID-II did not show any differences at @-month and @-months post-treatment .


These results indicated that rhEPO could have therapeutic efficacy for infants with CP during the active rehabilitation and anti-inflammation was suggested to be one of its therapeutic mechanisms .


The authors aimed to assess the effect of lower extremity nerve decompression surgery for painful diabetic polyneuropathy on pain and sensibility .


The study was conducted as a single-center randomized controlled trial of one intervention with @-year follow-up .


Forty-two patients with painful diabetic neuropathy were included .


After randomization , the lower extremity nerves were decompressed at four sites in one limb .


The contralateral limb was used as control ( within-patient comparison ) .


All patients were assessed preoperatively and at @ , @ , and @ months postoperatively .


Primary outcome was the visual analogue scale score @ months after surgery .


Secondary outcomes were Semmes Weinstein monofilament testing and two-point discrimination outcomes at @ , @ , and @ months .


Visual analogue scale scores improved significantly from a mean of @ ( @ percent CI , @ to @ ) preoperatively to @ ( @ percent CI , @ to @ ) at @ months postoperatively ( p < @ ) .


The score was also significantly lower compared with the control leg score of @ ( @ percent CI , @ to @ ; p < @ ) at @ months .


Overall , @ percent of the patients improved their score on the visual analogue scale , of which @ percent had a decrease of more than five points .


Surgical decompression of the nerves of the lower extremity can be added as a therapeutic option for patients with painful diabetic neuropathy who show signs of chronic nerve compression by means of a positive Tinel or other diagnostic criteria , when pain medication fails to reduce pain to an acceptable standard .


Therapeutic , I.


Acetylsalicylic acid is one of the most used analgesics to treat an acute migraine attack .


Next to the inhibitory effects on peripheral prostaglandin synthesis , central mechanisms of action have also been discussed .


Using a standardized model for trigeminal-nociceptive stimulation during fMRI scanning , we investigated the effect of acetylsalicylic acid on acute pain compared to saline in @ healthy volunteers in a double-blind within-subject design .


Painful stimulation was applied using gaseous ammonia and presented in a pseudo-randomized order with several control stimuli .


All participants were instructed to rate the intensity and unpleasantness of every stimulus on a VAS scale .


Based on previous results , we hypothesized to find an effect of ASA on central pain processing structures like the ACC , SI and SII as well as the trigeminal nuclei and the hypothalamus .


Even though we did not find any differences in pain ratings between saline and ASA , we observed decreased BOLD signal changes in response to trigemino-nociceptive stimulation in the ACC and SII after administration of ASA compared to saline .


This finding is in line with earlier imaging results investigating the effect of ASA on acute pain .


Contrary to earlier findings from animal studies , we could not find an effect of ASA on the trigeminal nuclei in the brainstem or within the hypothalamic area .


Taken together our study replicates earlier findings of an attenuating effect of ASA on pain processing structures , which adds further evidence to a possibly central mechanism of action of ASA .


The Prostate Cancer Prevention Trial ( PCPT ) was a @-year randomized , double-blind , placebo-controlled trial of the efficacy of finasteride for the prevention of prostate cancer with a primary outcome of histologically determined prevalence of prostate cancer at the end of @ years .


A systematic modeling process using logistic regression identified factors available at year @ that are associated with end-of-study ( EOS ) biopsy adherence at year @ , stratified by whether participants were ever prompted for a prostate biopsy by year @ .


Final models were evaluated for discrimination .


At year @ , @,@ men were available for analysis .


Participants were more likely to have the EOS biopsy if they were adherent to study visit schedules and procedures and/or were in good health ( P < @ ) .


Participants at larger sites and/or sites that received retention and adherence grants were also more likely to have the EOS biopsy ( P < @ ) .


Our results show good adherence to study requirements @ year before the EOS biopsy was associated with greater odds that a participant would comply with the invasive EOS requirement .


Monitoring adherence behaviors may identify participants at risk of nonadherence to more demanding study end points .


Such information could help frame adherence intervention strategies in future trials .


Chemoprevention offers a promising strategy for prevention of malaria in African children .


However , the optimal chemoprevention drug and dosing strategy is unclear in areas of year-round transmission and resistance to many antimalarial drugs .


To compare three available regimens , we conducted an open-label randomized controlled trial of chemoprevention in Ugandan children .


This study was conducted between June @ , @ , and September @ , @ infants were enrolled and @ randomized at @ mo of age to no chemoprevention , monthly sulfadoxine-pyrimethamine ( SP ) , daily trimethoprim-sulfamethoxazole ( TS ) , or monthly dihydroartemisinin-piperaquine ( DP ) .


Study drugs were administered at home without supervision .


Piperaquine ( PQ ) levels were used as a measure of compliance in the DP arm .


Participants were given insecticide-treated bednets , and caregivers were encouraged to bring their child to a study clinic whenever they were ill .


Chemoprevention was stopped at @ mo of age , and participants followed-up an additional year .


Primary outcome was the incidence of malaria during the intervention period .


During the intervention , the incidence of malaria in the no chemoprevention arm was @ episodes per person-year at risk .


Protective efficacy was @ % ( @ % CI , @ % -@ % , p < @ ) for DP , @ % ( @ % CI , @ % -@ % , p = @ ) for TS , and @ % for SP ( @ % CI , -@ % to @ % , p = @ ) .


PQ levels were below the detection limit @ % of the time when malaria was diagnosed in the DP arm , suggesting non-adherence .


There were no differences between the study arms in the incidence of serious adverse events during the intervention and the incidence of malaria during the @-y period after the intervention was stopped .


For preventing malaria in children living in an area of high transmission intensity , monthly DP was the most efficacious and safe , although adherence may pose a problem .


Monthly SP and daily TS may not be appropriate in areas with high transmission intensity and frequent resistance to antifolates .


To investigate the electrolyte changes between @-L polyethylene glycol with ascorbic acid @ g ( PEG-Asc ) and @-L PEG solutions .


From August @ to February @ , a total of @ patients were enrolled at four tertiary hospitals .


All patients were randomly allocated to a PEG-Asc group or a @-L PEG .


Before colonoscopy , patients completed a questionnaire to assess bowel preparation-related symptoms , satisfaction , and willingness .


Endoscopists assessed the bowel preparation using the Boston Bowel Preparation Scale ( BBPS ) .


In addition , blood tests , including serum electrolytes , serum osmolarity , and urine osmolarity were evaluated both before and after the procedure .


A total of @ patients were analyzed .


BBPS scores were similar and the adequate bowel preparation rate ( BBPS @ ) was not different between the two groups ( PEG-Asc vs @-L PEG , @ % vs @ % , P = @ ) .


Bowel preparation-related symptoms also were not different between the two groups .


The taste of PEG-Asc was better ( @ % vs @ % , P < @ ) , and the willingness to undergo repeated bowel preparation was higher in the PEG-Asc group ( @ % vs @ % , P = @ ) than in @-L PEG .


There were no significant changes in serum electrolytes in either group .


In this multicenter trial , bowel preparation with PEG-Asc was better than @-L PEG in terms of patient satisfaction , with similar degrees of bowel preparation and electrolyte changes .


The authors evaluated the effectiveness of using a patient simulator ( MARC Patient Simulator -LSB- MARC PS -RSB- , BlueLight analytics , Halifax , Nova Scotia , Canada ) , to instruct dental students ( DS ) on how to deliver energy optimally to a restoration from a curing light .


Five months later , the authors evaluated the retention of the instruction provided to the DS .


Toward the end of the DS ' first year of dental education , the authors evaluated the light-curing techniques of one-half of the class of first-year DS ( Group @ ) before and after receiving instruction by means of the patient simulator .


Five months later , they retested DS in Group @ and tested the remaining first-year DS who were then second-year DS and who had received no instruction by means of the patient simulator ( Group @ ) .


They gave DS in Group @ and Group @ MARC PS instruction and retested them .


The authors also the tested fourth-year DS ( Group @ ) and dentists ( Group @ ) by using the MARC PS before giving any instruction by means of the MARC PS .


The results of one-way analysis of variance ( ANOVA ) showed that there were no significant differences in the ability of dentists and DS to light cure a simulated restoration before they received instruction by means of the patient simulator ( P = @ ) .


The results of two-way ANOVA and Fisher protected least significant difference tests showed that after receiving instruction by means of the patient simulator , DS delivered significantly more energy to a simulated restoration , and this skill was retained .


There were no significant differences between DS in Group @ and Group @ after they had received instruction by means of the patient simulator .


The abilities of dentists and DS to light cure a simulated restoration were not significantly different .


Hands-on teaching using a patient simulator enhanced the ability of DS to use a curing light .


This skill was retained for at least five months .


The education provided to dentists and DS is insufficient to teach them how to deliver the optimum amount of energy from a curing light .


Better teaching and understanding of the importance of light curing is required .


Carers provide extended and often unrecognized support to people with cancer .


The aim of this study is to test the hypothesis that excessive carer burden is modifiable through a telephone outcall intervention that includes supportive care , information and referral to appropriate psycho-social services .


Secondary aims include estimation of changes in psychological health and quality of life .


The study will determine whether the intervention reduces unmet needs among patient dyads .


A formal economic program will also be conducted .


This study is a single-blind , multi-centre , randomized controlled trial to determine the efficacy and cost-efficacy of a telephone outcall program among carers of newly diagnosed cancer patients .


A total of @ carer/patient dyads will be recruited into the study ; following written consent , carers will be randomly allocated to either the outcall intervention program ( n = @ ) or to a minimal outcall / attention control service ( n = @ ) .


Carer assessments will occur at baseline , at one and six months post-intervention .


The primary outcome is change in carer burden ; the secondary outcomes are change in carer depression , quality of life , health literacy and unmet needs .


The trial patients will be assessed at baseline and one month post-intervention to determine depression levels and unmet needs .


The economic analysis will include perspectives of both the health care sector and broader society and comprise a cost-consequences analysis where all outcomes will be compared to costs .


This study will contribute to our understanding on the potential impact of a telephone outcall program on carer burden and provide new evidence on an approach for improving the wellbeing of carers .


Pooled analysis is a powerful technique that is increasingly used to detect differences in efficacy between pharmacologic agents .


Some studies have compared the efficacy and tolerability of citalopram and escitalopram , with contradictory results .


The aim of this study was to compare the efficacy and tolerability of citalopram and escitalopram in the treatment of major depressive disorder ( MDD ) using pooled analyses .


Data from @ randomized , double-blind studies that compared citalopram ( @ to @ mg/d ) and escitalopram ( @ to @ mg/d ) were pooled and analyzed .


The primary efficacy parameter was change from baseline in the @-item Hamilton Rating Scale for Depression ( HAM-D-@ ) total score .


Efficacy assessments were made at weeks @ ( baseline ) , @ , @ , @ , and @ .


Based on the mean change from baseline in the HAM-D-@ at weeks @ , @ , @ , and @ , the efficacy of citalopram , @ to @ mg/d , was equivalent to escitalopram , @ to @ mg/d ( P > @ ) .


Similar results were seen for severely depressed patients , with a mean treatment difference of @ ( SE = @ ) vs @ ( SE = @ ) .


Response and remission rates at week @ were similar ( response , @ % for citalopram , compared with @ % for escitalopram ; remission , @ % vs @ % , respectively ) .


The pooled analysis showed that over a @-week treatment period , citalopram , @ to @ mg/d , is equivalent to escitalopram , @ to @ mg/d , in both efficacy and tolerability .


This study was done to compare percutaneous laser ablation ( PLA ) and radiofrequency thermoablation ( RFA ) for the treatment of hepatocellular carcinoma ( HCC ) @ cm , in patients with liver cirrhosis .


Thirty patients with single HCC @ cm in diameter were randomly assigned to one of two treatments : @ patients were treated with PLA , using a multifibre system connected to a neodymium yttrium-aluminium-garnet laser source ; @ patients were treated with RFA , using an expandable needle electrode .


Patients were followed up for up to @ months .


A complete response was obtained in @ % lesions treated with PLA and in @ % lesions treated with RFA ( p = ns ) .


The overall local recurrence-free survival rates at @ , @ and @ months were comparable .


However , a higher rate of recurrence was observed in the PLA group for lesions @ mm ( p = @ ) .


A postablation syndrome was documented in @ patients ( @ PLA ; @ RFA ) .


Tumour necrosis factor - was significantly higher in the RFA group ( p < @ ) .


RFA is more effective in the treatment of HCC compared to PLA for lesions @ mm .


However , PLA should be considered a viable treatment option for HCC @ mm , in view of the lower incidence of complications .


Although the benefit of reducing blood pressure for primary and secondary prevention of stroke has been established , the effect of antihypertensive treatment in patients with acute ischemic stroke is uncertain .


To evaluate whether immediate blood pressure reduction in patients with acute ischemic stroke would reduce death and major disability at @ days or hospital discharge .


The China Antihypertensive Trial in Acute Ischemic Stroke , a single-blind , blinded end-points randomized clinical trial , conducted among @ patients with nonthrombolysed ischemic stroke within @ hours of onset and elevated systolic blood pressure .


Patients were recruited from @ hospitals across China between August @ and May @ .


Patients ( n = @ ) were randomly assigned to receive antihypertensive treatment ( aimed at lowering systolic blood pressure by @ % to @ % within the first @ hours after randomization , achieving blood pressure less than @/@ mm Hg within @ days , and maintaining this level during hospitalization ) or to discontinue all antihypertensive medications ( control ) during hospitalization ( n = @ ) .


Primary outcome was a combination of death and major disability ( modified Rankin Scale score @ ) at @ days or hospital discharge .


Mean systolic blood pressure was reduced from @ mm Hg to @ mm Hg ( -@ % ) within @ hours in the antihypertensive treatment group and from @ mm Hg to @ mm Hg ( -@ % ) in the control group within @ hours after randomization ( difference , -@ % -LSB- @ % CI , -@ to -@ % -RSB- ; absolute difference , -@ mm Hg -LSB- @ % CI , -@ to -@ -RSB- ; P < @ ) .


Mean systolic blood pressure was @ mm Hg in the antihypertensive treatment group and @ mm Hg in the control group at day @ after randomization ( difference , -@ mm Hg -LSB- @ % CI , -@ to -@ -RSB- ; P < @ ) .


The primary outcome did not differ between treatment groups ( @ events -LSB- antihypertensive treatment -RSB- vs @ events -LSB- control -RSB- ; odds ratio , @ -LSB- @ % CI , @ to @ -RSB- ; P = @ ) at @ days or hospital discharge .


The secondary composite outcome of death and major disability at @-month posttreatment follow-up did not differ between treatment groups ( @ events -LSB- antihypertensive treatment -RSB- vs @ events -LSB- control -RSB- ; odds ratio , @ -LSB- @ % CI , @ to @ -RSB- ; P = @ ) .


Among patients with acute ischemic stroke , blood pressure reduction with antihypertensive medications , compared with the absence of hypertensive medication , did not reduce the likelihood of death and major disability at @ days or hospital discharge .


Reactivity to smoking cues is an important factor in the motivation to smoke and has been associated with the dopamine receptor @ variable number tandem repeat ( DRD@ exon III VNTR ) polymorphism .


However , little is known about the associated neural mechanisms .


Non-treatment-seeking Caucasian smokers completed overnight abstinence and viewed smoking and neutral cues during @ separate functional magnetic resonance imaging scans while wearing either a nicotine or placebo patch ( order randomized ) and were genotyped for the DRD@ VNTR .


We conducted mixed-effects repeated-measures analyses of variance ( within-subject factor : nicotine or placebo patch ; between-subject factor : DRD@ long -LSB- L : @ copy of @ repeats -RSB- or short -LSB- S : @ copies @ repeats -RSB- genotype ) of @ a priori regions of interest .


Relative to neutral cues , smoking cues elicited greater activity in bilateral ventral striatum and left amygdala during nicotine replacement and deactivation in these regions during nicotine deprivation .


A patch DRD@ interaction was observed in the left amygdala , an area associated with appetitive reinforcement and relapse risk , such that S allele carriers demonstrated greater activation on active patch than on placebo patch .


Brain systems associated with reward salience may become primed and overreactive at nicotine replacement doses intended for the first step of smoking cessation and may become inhibited during nicotine withdrawal in DRD@ S but not in DRD@ L carriers .


These findings are consistent with the role of these regions in drug reinforcement and suggest a differential influence of nicotine replacement on amygdala activation in the association of incentive salience with smoking stimuli across DRD@ genotypes .


This double-blind , randomized , placebo-controlled study investigated the impact of repetitive transcranial magnetic stimulation ( rTMS ) on quality of life ( QoL ) of patients with fibromyalgia , and its possible brain metabolic substrate .


Thirty-eight patients were randomly assigned to receive high-frequency rTMS ( n = @ ) or sham stimulation ( n = @ ) , applied to left primary motor cortex in @ sessions over @ weeks .


Primary clinical outcomes were QoL changes at the end of week @ , measured using the Fibromyalgia Impact Questionnaire ( FIQ ) .


Secondary clinical outcomes were mental and physical QoL component measured using the @-Item Short Form Health Survey ( SF-@ ) , but also pain , mood , and anxiety .


Resting-state -LSB- ( @ ) F -RSB- - fluorodeoxyglucose-PET metabolism was assessed at baseline , week @ , and week @ .


Whole-brain voxel-based analysis was performed to study between-group metabolic changes over time .


At week @ , patients of the active rTMS group had greater QoL improvement in the FIQ ( p = @ ) and in the mental component of the SF-@ ( p = @ ) than the sham stimulation group .


No significant impact was found for other clinical outcomes .


Compared with the sham stimulation group , patients of the active rTMS group presented an increase in right medial temporal metabolism between baseline and week @ ( p < @ ) , which was correlated with FIQ and mental component SF-@ concomitant changes ( r = -@ , p = @ ; r = @ , p = @ , respectively ) .


QoL improvement involved mainly affective , emotional , and social dimensions .


Our study shows that rTMS improves QoL of patients with fibromyalgia .


This improvement is associated with a concomitant increase in right limbic metabolism , arguing for a neural substrate to the impact of rTMS on emotional dimensions involved in QoL .


This study provides Class II evidence that rTMS compared with sham rTMS improves QoL in patients with fibromyalgia .


Long-term Mechanical Low-Back Pain ( LMLBP ) negatively impacts on patients ' physical capacity and quality of life .


This study investigated the relationship between Health-Related Quality of Life ( HRQoL ) and pain intensity , and the influence of static and dynamic back extensors ' endurance exercises on HRQoL in Nigerian patients with LMLBP treated with the McKenzie Protocol ( MP ) .


A single-blind controlled trial involving @ patients who received treatment thrice weekly for eight weeks was conducted .


Participants were assigned to the MP Group ( MPG ) , MP plus Static Back Endurance Exercise Group ( MPSBEEG ) or MP plus Dynamic Endurance Exercise Group ( MPDBEEG ) using permuted randomization .


HRQoL and pain was assessed using the Short-Form ( SF-@ ) questionnaire and Quadruple Visual Analogue Scale respectively .


Sixty seven participants aged @ @ years completed the study .


A total drop-out rate of @ % was observed in the study .


Within-group comparison across weeks @-@ , @-@ and @-@ of the study revealed significant differences in HRQoL scores ( p < @ ) .


Treatment Effect Scores ( TES ) across the groups were significantly different ( p = @ ) .


MPSBEEG and MPDBEEG were comparable in TES on General Health Perception ( GHP ) at week @ ; and GHP and Physical Functioning at week @ respectively ( p > @ ) .


However , MPDEEG had significantly higher TES in the other domains of the SF-@ ( p = @ ) .


HRQoL in patients with LMLBP decreases with pain severity .


Each of MP , static and dynamic back extensors endurance exercises significantly improved HRQoL in LMLBP .


However , the addition of dynamic back extensors endurance exercise to MP led to greater improvement in HRQoL .


High-grade prostatic intraepithelial neoplasia ( HGPIN ) is considered a precursor lesion of prostate cancer ( PCa ) .


The predictive value of ERG gene fusion in HGPIN for PCa was interrogated as a post hoc analysis in the context of a randomized clinical trial .


The GTx Protocol G@ randomly assigned @,@ men with biopsy-diagnosed HGPIN to receive toremifene or placebo for @ years or until a diagnosis of PCa was made on prostate biopsy .


As part of this phase III clinical trial , a central pathologist evaluated biopsies of patients with isolated HGPIN at baseline and @ , @ , and @ months of follow-up .


ERG immunohistochemistry was performed on biopsies from @ patients and evaluated for protein overexpression .


ERG expression was detected in @ % of patients ( @ of @ patients ) with isolated HGPIN .


In the first year and during the @-year clinical trial , @ % and @ % of @ patients were diagnosed with PCa , respectively .


Patients with ERG expression were more likely to develop PCa , with @ ( @ % ) of @ ERG-positive and @ ( @ % ) of @ ERG-negative patients experiencing progression to PCa ( P = @ , Fisher 's exact test ) .


ERG expression was not associated with age , baseline PSA , Gleason score , or tumor volume .


This study underscores the necessity of more stringent follow-up for men with HGPIN that is also positive for ERG overexpression .


Clinicians should consider molecular characterization of HGPIN as a means to improve risk stratification .


Limited disease knowledge is frequently the cause of disease-related anxiety in myocardial infarction patients .


The ability to communicate effectively serves multiple purposes in the professional nursing practice .


By communicating effectively with myocardial infarction patients , nurses may help reduce their anxiety by keeping them well informed about their disease and teaching them self-care strategies .


This research evaluates the communication skills of nurses following scenario-based simulation education in the context of communication with myocardial infarction patients .


This study used an experimental design and an educational intervention .


The target population comprised nurses of medicine ( clinical qualified level N to N@ for nursing ) working at a municipal hospital in Taipei City , Taiwan .


A total @ participants were enrolled .


Stratified block randomization divided participants into an experimental group and a control group .


The experimental group received clinical scenario-based simulation education for communication .


The control group received traditional class-based education for communication .


Both groups received a pre-test and a Communication Skills Checklist post-test assessment .


Results were analyzed using SPSS @ for Windows software .


A t-test showed significant increases in communication skills ( p < @ ) in the experimental group and ANCOVA results identified significant between-group differences ( p < @ ) in communication skills following the education intervention .


The results indicate that clinical scenario-based simulation education for communication is significantly more effective than traditional class-based education in enhancing the ability of nurses to communicate effectively with myocardial infarction patients .


To observe the effects on post-stroke depression treated with acupuncture at the acu points based on ziwuliuzhu ( the midnight-noon ebb-flow theory ) .


Ninety-three patients were randomized into a comprehensive group , a ziwuliuzhu group and a prozac group , @ cases in each group .


In the ziwuliuzhu group , acupuncture was applied to the acupoints based on ziwuliuzhu , once a day , @ times in a week .


In the prozac group , fluoxertine hydrochloride ( prozac ) was prescribed for oral administration , once a day , @ mg each time .


In the comprehensive group , acupuncture based on ziwuliuzhu combined with the oral administration of prozac were adopted and the treatment frequency was the same as the ziwuliuzhu group and the prozac group .


The @-week treatment was taken as one session in the three groups and @ sessions were required totally .


The clinical efficacy and the Hamilton depression rating scale ( HAMD ) score and the adverse reaction were compared among the @ groups .


The total effective rate was @ % ( @/@ ) in the comprehensive group , better than @ % ( @/@ ) in the ziwuliuzhu group and @ % ( @/@ ) in the prozac group ( both P < @ ) .


In @ , @ and @ weeks of treatment , HAMD score was lower significantly than that before the treatment in the three groups ( all P < @ ) , and the score in the comprehensive group at each time point after treatment was lower than the other two groups ( all P < @ ) .


In @ and @ weeks of treatment , there were not different significantly between the ziwuliuzhu group and the prozac group ( both P > @ ) .


In @ weeks of treatment , HAMD score in the ziwuliuzhu group was lower than that in the prozac group ( P < @ ) .


For the adverse reaction , there were @ cases in the comprehensive group , @ cases in the prozac group and @ case in the ziwzuliuzhu group .


The comprehensive therapy of acupuncture at the acupoints based on ziwuliuzhu and oral administration of prozac is superior to either the simple oral administration of prozac or the ziwuliuzhu acu-puncture in terms of clinical efficacy and the improvements in depressive state .


Regarding the clinical efficacy , the impact of simple ziwuliuzhu acupuncture is not different significantly as compared with the simple oral administration of prozac , but it is better than the simple oral administration of prozac in terms of the long-term HAMD score and safety .


A hardcopy or paper cognitive aid has been shown to improve performance during the management of simulated local anesthetic systemic toxicity ( LAST ) when given to the team leader .


However , there remains room for improvement to ensure a system that can achieve perfect adherence to the published guidelines for LAST management .


Recent research has shown that implementing a checklist via a designated reader may be of benefit .


Accordingly , we sought to investigate the effect of an electronic decision support tool ( DST ) and designated `` Reader '' role on team performance during an in situ simulation of LAST .


Participants were randomized to Reader + DST ( n = @ , rDST ) and Control ( n = @ , memory alone ) .


The rDST group received the assistance of a dedicated Reader on the response team who was equipped with an electronic DST .


The primary outcome measure was adherence to guidelines .


For overall and critical percent correct scores , the rDST group scored higher than Control ( @ % vs @ % , P < @ ; @ % vs @ % , P < @ , respectively ) .


In the LAST scenario , @ ( @ % ) of @ in the control group performed @ % of critical management steps , whereas @ ( @ % ) of @ in the rDST group did so ( P < @ ) .


In a prospective , randomized single-blinded study , a designated Reader with an electronic DST improved adherence to guidelines in the management of an in situ simulation of LAST .


Such tools are promising in the future of medicine , but further research is needed to ensure the best methods for implementing them in the clinical arena .


To evaluate multiple doses of gabapentin @ mg on polysomnography ( PSG ) and participant-reported sleep assessments in a @-h phase advance insomnia model .


Adults reporting occasional disturbed sleep received gabapentin @ mg ( n = @ ) or placebo ( n = @ ) .


On Days @ and @ , participants received medication @ min before bedtime and were in bed from @:@ to @:@ , @ h before their habitual bedtime .


Sleep was assessed by PSG , a post sleep questionnaire , and the Karolinska Sleep Diary .


Next-day residual effects and tolerability were evaluated .


On Days @-@ , participants took medication at home @ min before their habitual bedtime .


Treatment-group demographics were comparable .


Gabapentin resulted in significantly less PSG wake after sleep onset ( WASO ) compared with placebo on Day @ ( primary endpoint , mean : @ versus @ min , p @ ) and Day @ ( @ versus @ min , p = @ ) , and significantly greater total sleep time ( TST ; Day @ : @ versus @ min ; Day @ : @ versus @ min ) ( p @ ) .


Participant-reported WASO and TST also showed significant treatment effects on both days .


Gabapentin was associated with less % stage@ on Day @ , and greater % REM on Day @ , versus placebo .


During home use , gabapentin resulted in significantly less participant-reported WASO and higher ratings of sleep quality .


Gabapentin was well tolerated ( most common adverse events : headache , somnolence ) with no evidence of next-day impairment .


Gabapentin @ mg resulted in greater PSG and participant-reported sleep duration following a @-h phase advance on Day @ and Day @ of use without evidence of next-day impairment , and greater sleep duration during at-home use .


Ageing populations may demand more blood transfusions , but the blood supply could be limited by difficulties in attracting and retaining a decreasing pool of younger donors .


One approach to increase blood supply is to collect blood more frequently from existing donors .


If more donations could be safely collected in this manner at marginal cost , then it would be of considerable benefit to blood services .


National Health Service ( NHS ) Blood and Transplant in England currently allows men to donate up to every @ weeks and women to donate up to every @ weeks .


In contrast , some other European countries allow donations as frequently as every @ weeks for men and every @ weeks for women .


The primary aim of the INTERVAL trial is to determine whether donation intervals can be safely and acceptably decreased to optimise blood supply whilst maintaining the health of donors .


INTERVAL is a randomised trial of whole blood donors enrolled from all @ static centres of NHS Blood and Transplant .


Recruitment of about @,@ male and female donors started in June @ and was completed in June @ .


Men have been randomly assigned to standard @-week versus @-week versus @-week inter-donation intervals , while women have been assigned to standard @-week versus @-week versus @-week inter-donation intervals .


Sex-specific comparisons will be made by intention-to-treat analysis of outcomes assessed after two years of intervention .


The primary outcome is the number of blood donations made .


A key secondary outcome is donor quality of life , assessed using the Short Form Health Survey .


Additional secondary endpoints include the number of ` deferrals ' due to low haemoglobin ( and other factors ) , iron status , cognitive function , physical activity , and donor attitudes .


A comprehensive health economic analysis will be undertaken .


The INTERVAL trial should yield novel information about the effect of inter-donation intervals on blood supply , acceptability , and donors ' physical and mental well-being .


The study will generate scientific evidence to help formulate blood collection policies in England and elsewhere .


A randomised crossover trial .


To determine the effects of a @-week standing programme on bowel function in people with spinal cord injury .


Community , Australia and the United Kingdom .


Twenty community-dwelling people with motor complete spinal cord injury above T@ participated in a @-week trial .


The trial consisted of a @-week stand phase and a @-week no-stand phase separated by a @-week washout period .


Participants were randomised to one of two treatment sequences .


Participants allocated to the Treatment First group stood on a tilt table for @min per session , five times per week for @ weeks and then did not stand for the next @ weeks .


Participants allocated to the Control First group did the opposite : they did not stand for @ weeks and then stood for @ weeks .


Participants in both groups received routine bowel care throughout the @-week trial .


Assessments occurred at weeks @ , @ , @ and @ corresponding with pre and post stand and no-stand phases .


The primary outcome was Time to First Stool .


There were seven secondary outcomes reflecting other aspects of bowel function and spasticity .


There were three dropouts leaving complete data sets on @ participants .


The mean ( @ % confidence interval ) between-intervention difference for Time to First Stool was @min ( -@ to @ ) indicating no effect of regular standing on Time to First Stool .


Regular standing does not reduce Time to First Stool .


Further trials are required to test the veracity of some commonly held assumptions about the benefits of regular standing for bowel function .


To explore the effects of phytoestrogen ( PE ) on blood lipid and bone density in postmenopausal women .


A total of @ menopausal women aged @-@ years with estrogen reduction symptoms received an intake of soy protein containing @ mg isoflavone daily in a year .


Their changes of blood fat , density lumbar bone and sex hormone level were compared with control group without an intake .


The changes of blood triglyceride ( TG ) , total cholesterol ( TC ) and low-density lipoprotein ( LDL ) in two groups before and after a year showed no statistical significance.High-density lipoprotein ( HDL ) decreased in control group while it had no significant change in the study group .


Bone densities in two groups showed a downward trend by an annual rate of @ % -@ % , the changes in two groups showed no statistical significance.E@ increased slightly over basic value in the study group .


But it had no statistical significance .


The changes of follicle-stimulating hormone ( FSH ) in two groups were also similar .


The above soy protein preparation has no effect on hypothalamic-pituitary-ovarian axis and no stimulation on endometrium of uterus .


But it may improve the profile of HDL .


To understand degeneration of healthy sites and identify factors associated with disease progression in patients with chronic periodontitis .


Data on healthy sites from @ American and Swedish subjects were analysed using two-three-state ( health , gingivitis , chronic periodontitis ) Markov models based on bleeding on probing ( BOP ) , and either clinical attachment level ( CAL ) + BOP or pocket depth ( PD ) + BOP .


In @years , @ % ( CAL+BOP ) and @ % ( PD+BOP ) of healthy sites developed chronic periodontitis .


On average , healthy sites remained healthy for @months before transiting in both models .


Most transitions ( @-@ % ) from health were to the gingivitis state .


The expected duration of the gingivitis lesion was @-@months and sites recovered with a high probability ( @-@ % ) .


Disease severity as measured by number of sites with CAL/PD > @mm at baseline and smoking , were associated with fast progression from health to chronic periodontitis within @months as were gingival redness in the PD+BOP model only .


With age , the rate of disease progression to gingivitis decreased .


Transition probabilities for gingivitis and chronic periodontitis were higher with CAL+BOP than with PD+BOP .


Smoking and disease severity were significant predictors for fast progression .


To investigate changes in the pain-suppressing potency of @ preoperatively applied topical nonsteroidal antiinflammatory drugs ( NSAIDs ) after photorefractive keratectomy ( PRK ) using a time-serial pain-scoring system .


Saeyan Eye Center , Seoul , South Korea .


Comparative case series .