The oxycodone consumed during first 20h after surgery was 42.5 ( 95 % confidence interval 38.3-46 .6 ) mg and 42.8 ( 37.3-48 .4 ) mg in propofol - and sevoflurane-anaesthetised patients , respectively ( P = 0.919 ) .


NRS scores for nausea were higher in the patients receiving sevoflurane during the first 60min in the post-anaesthesia care unit , leading to higher consumption of rescue antiemetics .


Sedation scores differed in favour of sevoflurane only at 4h time point after anaesthesia .


Patient characteristics did not differ .


In this study , comparing sevoflurane with propofol for maintenance of general anaesthesia , the choice of anaesthetic had no effect on the requirement of oxycodone or intensity of pain after surgery .


Infection with the bacterial pathogen Helicobacter pylori ( HP ) clearly results in chronic mucosal inflammation in the stomach and duodenum , which , in turn , might lead to abnormalities in gastroduodenal motility and sensitivity and is the most frequent cause of dyspepsia and peptic disease .


Some studies have shown that there was a correlation between low-grade inflammation as C-reactive protein ( CRP ) and HP infection .


The aim of this study was to investigate the relationship between the presence of gastritis due to HP infection and neutrophil/lymphocyte ratio ( NLR ) , a simple and reliable indicator of inflammation .


Fifty patients met the HP criteria and half of them have had severe symptoms and upper endoscopy showed atrophic gastritis , and fifty age - and sex-matched control subjects with gastritis without HP infection were included in this randomized controlled trial .


Patients were diagnosed to have HP according to the use of urea breath testing ( UBT ) and multiple biopsies .


NLR was calculated from complete blood count at the time of diagnosis and before initiating the treatment to all groups .


Patients with HP infection had significantly higher NLR compared to those without HP .


Moreover , the patients with symptomatic HP and grade 4 gastritis had higher NLR than those asymptomatic with past history of peptic disease ( P 0.007 and P 0.068 , respectively ) .


Although NLR increased as the severity of gastritis and HP symptoms increased ( r = 0.564 , P < 0.001 ) , Receiver operating characteristic ( ROC ) Curve analysis was performed .


The cut-off level for NLR with optimal sensitivity and specificity was calculated as 1.82 ( area under curve [ AUC ] = 0.825 [ 0.753-0 .884 ] , P < 0.001 ) .


The present study indicated , for the first time , a significant correlation between HP infection and inflammation on the basis of NLR , a simple and reliable indicator of inflammation .


Furthermore , there is an increase in NLR as the severity of gastritis with HP increases .


This elevated ratio gets normalized with treatment .


Only 63 % of the US population aged 50-75 years is adherent with recommended colorectal cancer ( CRC ) screening guidelines .


Efforts are needed to increase screening for CRC .


We evaluated a quality improvement intervention conducted in 2010 at Group Health in Washington State to assess the use of interactive voice response ( IVR ) systems to improve CRC screening .


Eligible members were aged 50-81 years , received primary care from a contracted physician , and were due for CRC screening .


A total of 13,279 members were identified and randomly assigned to either : ( 1 ) an intervention with IVR to encourage CRC screening ( n = 10,000 ) , or ( 2 ) usual care ( n = 3279 ) .


The primary outcome was receipt of any recommended CRC screening test at 6 months postintervention or index date .


We used Cox proportional hazards to model time until receipt of CRC screening at 6 months .


Adherence to CRC screening was 10.0 % in the intervention arm and 7.8 % in the usual care arm at 6 months .


Randomization to the IVR intervention arm was associated with a 32 % increased likelihood of receiving CRC screening ( hazard ratio = 1.32 ; 95 % confidence interval , 1.14 , 1.52 ) compared with usual care .


The difference in CRC screening uptake was apparent by 3 months and persisted for 12 months postintervention ( log-rank test , P = 0.0012 ) .


Our analysis provides `` real-world '' evidence that IVR is effective when delivered by a commercial health plan , and may be a useful tool for increasing adherence to screening guidelines among patients outside an integrated care practice .


Cholangiocellular carcinoma is the second most common primary liver cancer after hepatocellular carcinoma .


Over the last 30years , the incidence of intrahepatic cholangiocellular carcinoma has risen continuously worldwide .


Meanwhile , the intrahepatic cholangiocellular carcinoma has become more common than the extrahepatic growth type and currently accounts for 10-15 % of all primary hepatic malignancies .


Intrahepatic cholangiocellular carcinoma is typically diagnosed in advanced stages due to late clinical symptoms and an absence of classic risk factors .


A late diagnosis precludes curative surgical resection .


There is evidence that transarterial chemoembolization leads to better local tumor control and prolongs survival compared to systemic chemotherapy .


New data indicates that selective internal radiotherapy , also referred to as radioembolization , provides promising results for treating intrahepatic cholangiocellular carcinoma .


This pilot study is a randomized , controlled , single center , phase II trial .


Twenty-four patients with intrahepatic cholangiocellular carcinoma will be randomized in a 1:1 ratio to receive either chemoembolization or radioembolization .


Randomization will be stratified according to tumor load .


Progression-free survival is the primary endpoint ; overall survival and time to progression are secondary endpoints .


To evaluate treatment success , patients will receive contrast enhanced magnetic resonance imaging every 3months .


Currently , chemoembolization is routinely performed in many centers instead of systemic chemotherapy for treating intrahepatic cholangiocellular carcinoma confined to the liver .


Recently , radioembolization has been increasingly applied to cholangiocellular carcinoma as second line therapy after TACE failure or even as an alternative first line therapy .


Nonetheless , no randomized studies have compared radioembolization and chemoembolization .


Considering all this background information , we recognized a strong need for a randomized controlled trial ( RCT ) to compare the two treatments .


Therefore , the present protocol describes the design of a RCT that compares SIRT and TACE as the first line therapy for inoperable CCC confined to the liver .


ClinicalTrials.gov , Identifier : NCT01798147 , registered 16th of February 2013 .


Exercise training increasingly is recommended as an important part of the management of cardiovascular disease .


However , few studies have evaluated the effectiveness of exercise training in patients with chronic kidney disease ( CKD ) , and those that have included very selective populations .


Analysis of secondary outcomes of a randomized controlled trial , with participants randomly assigned to either lifestyle intervention or usual care ( control ) .


Patients with CKD stages 3 to 4 and one or more uncontrolled cardiovascular risk factor were recruited from an outpatient clinic at a large tertiary hospital .


Lifestyle intervention included access to multidisciplinary care through a nurse practitioner-led CKD clinic , exercise training , and a lifestyle program .


The exercise training was a 2-phased program in which participants received 8 weeks of supervised training before commencing 10 months of home-based training .


Efficacy , as assessed by metabolic equivalent tasks ( METs ) , 6-minute walk distance , Timed Get-Up-and-Go test , grip strength , and anthropomorphic measures ; adherence , as assessed by self-reported physical activity ; and safety , as assessed by reported serious adverse events , were recorded .


83 patients were randomly assigned and 72 patients completed follow-up testing ( intervention , n = 36 ; control , n = 36 ) .


The intervention resulted in a significant improvement in METs ( pre , 7.23.3 ; post , 9.73.6 ) , 6-minute walk distance ( pre , 485110m ; post , 53982m ) , and body mass index ( pre , 32.56.7 kg/m ( 2 ) ; post , 31.97.3 kg/m ( 2 ) ) .


Reported physical activity levels significantly increased in the intervention group at 6 months , but decreased at 12 months .


There were no serious adverse events related to the exercise training .


This study was not powered to evaluate the safety of exercise training on serious adverse events .


The findings from the present study suggest that an exercise program that includes a supervised and home-based training phase is effective , adhered to , and safe in patients with CKD .


There is a paucity of evidence for outcome predictors in patients with major depressive disorder ( MDD ) not responding to initial antidepressant therapy ( ADT ) .


This post-hoc analysis evaluated whether MDD severity affects response to adjunctive aripiprazole .


Data from 3 randomized , double-blind , placebo-controlled trials of adjunctive aripiprazole in adults with MDD and inadequate response to 1 to 3 ADT trials were pooled and stratified based on Montgomery-sberg Depression Rating Scale ( MADRS ) total score ( mild , 24 ; moderate , 25-30 ; severe , 31 ) .


Treatment differences in change in MADRS total score and rates of response ( 50 % MADRS improvement ) and remission ( response with MADRS total score 10 ) were analyzed at endpoint .


Adverse events were assessed within each subgroup .


Aripiprazole produced greater improvement than placebo in the MADRS total score regardless of MDD severity at baseline ( between-treatment difference [ 95 % CI ] : mild , -2.5 [ -4.0 to -1.1 ] ; moderate , -3.2 [ -4.9 to -1.6 ] ; severe , -4.5 [ -6.8 to -2.2 ] ) .


Compared with placebo , adjunctive aripiprazole increased the likelihood of response in all subgroups ( risk ratio [ 95 % CI ] : mild , 1.50 [ 1.15 , 1.95 ] ; moderate , 1.51 [ 1.09 , 2.11 ] ; severe , 1.95 [ 1.23 , 3.10 ] ) .


Common treatment-emergent adverse events included akathisia and restlessness .


The original studies were not designed to assess the efficacy of adjunctive aripiprazole by baseline severity , and this post-hoc analysis was not powered to evaluate differences in severity subgroups .


In patients who failed to respond to initial ADT , adjunctive aripiprazole was more effective than placebo in mild , moderate , and severe MDD strata .


ClinicalTrial.gov : NCT00095823 , NCT00105196 , and NCT00095758 .


This study aims to estimate the value of embryonal natural orifice transluminal endoscopic surgery ( ENOTES ) as a treatment for severe acute pancreatitis ( SAP ) complicated by abdominal compartment syndrome ( ACS ) .


The patients who were randomized into ENOTES group and surgery group underwent ENOTES and laparotomy , respectively .


The Efficacy and complications of these two treatments were compared .


Enterocinesia was observed earlier in patients of ENOTES group than that of surgery group .


Acute Physiology and Chronic Health Evaluation II ( APACHE II ) score of patients in ENOTES group was superior to that of surgery group on the 1st , 3rd and 5th day after treatment ( P < 0.05 ) .


The cure rate was 96.87 % in ENOTES group , which was statistically different from 78.12 % in surgery group ( P < 0.05 ) .


Significant differences in complications and mortality were observed between two groups ( P < 0.01 ) .


Compared with surgical abdominal decompression , ENOTES and flexible endoscope therapy is a more effective and minimal invasive surgery with less complications .


This study addresses the extent to which DSM-IV and DSM-5 definitions of acute stress disorder ( ASD ) predict subsequent posttraumatic stress disorder ( PTSD ) and related psychiatric disorders following trauma .


Patients with randomized admissions to 5 hospitals across Australia ( N = 596 ) were assessed in hospital and reassessed for PTSD at 3 ( n = 508 ) , 12 ( n = 426 ) , 24 ( n = 439 ) , and 72 ( n = 314 ) months using the Clinician-Administered PTSD Scale ; DSM-IV definition of PTSD was used at each assessment , and DSM-5 definition was used at 72 months .


The Mini-International Neuropsychiatric Interview ( MINI ) was used at each assessment to assess anxiety , mood , and substance use disorders .


Forty-five patients ( 8 % ) met DSM-IV criteria , and 80 patients ( 14 % ) met DSM-5 criteria for ASD .


PTSD was diagnosed in 93 patients ( 9 % ) at 3 , 82 patients ( 10 % ) at 12 , 100 patients ( 12 % ) at 24 , and 26 patients ( 8 % ) at 72 months ; 19 patients ( 6 % ) met DSM-5 criteria for PTSD at 72 months .


Comparable proportions of those diagnosed with ASD developed PTSD using DSM-IV ( 3 months = 46 % , 12 months = 39 % , 24 months = 32 % , and 72 months = 25 % ) and DSM-5 ( 43 % , 42 % , 33 % , and 24 % ) ASD definitions .


Sensitivity was improved for DSM-5 relative to DSM-IV for depression ( 0.18 vs 0.30 ) , panic disorder ( 0.19 vs 0.41 ) , agoraphobia ( 0.14 vs 0.40 ) , social phobia ( 0.12 vs 0.44 ) , specific phobia ( 0.24 vs 0.58 ) , obsessive-compulsive disorder ( 0.17 vs 0.47 ) , and generalized anxiety disorder ( 0.20 vs 0.47 ) .


More than half of participants with DSM-5-defined ASD had a subsequent disorder .


The DSM-5 criteria for ASD results in better identification of people who will subsequently develop PTSD or another psychiatric disorder relative to the DSM-IV criteria .


Although prediction is modest , it suggests that the new ASD diagnosis can serve a useful function in acute trauma settings for triaging those who can benefit from either early intervention or subsequent monitoring .


The primary objective of this study was to compare the bioavailability of paracetamol , phenylephrine hydrochloride and guaifenesin in a new oral syrup with an established oral reference product .


The secondary objective was to compare the safety of the new syrup and the reference product .


This was a single-centre , open-label , randomized , reference-replicated , crossover study .


Healthy adult volunteers received one dose of syrup and two separate doses of a reference oral liquid formulation in a randomized sequence over three study periods , with a washout interval of 7 days between study periods .


Blood samples were taken regularly postdose and analysed for paracetamol , phenylephrine hydrochloride and guaifenesin concentrations ; adverse events were recorded .


This study enrolled 45 subjects .


For paracetamol and guaifenesin , the syrup and reference product were considered to be bioequivalent .


Bioequivalence was not shown for phenylephrine hydrochloride .


All adverse events were mild or moderate , most of which were considered formulation related .


The syrup did not reach bioequivalence with the reference product , as bioequivalence could not be shown for phenylephrine hydrochloride .


This may be due to differences in the excipients between the two products .


Both the syrup and the reference product had a good safety profile and were well tolerated .


A randomised , double-blind clinical trial was conducted comparing the efficacy of tranexamic acid ( TXA ) as a single intravenous bolus or a continuous infusion to patients undergoing total knee arthroplasty ( TKA ) .


Study hypothesis was that a second dose of TXA would not offer any clinical benefits over the single infusion .


One hundred and six patients were randomised to a single intraoperative dose of 30 mg/kg tranexamic acid ( OS group , n = 54 ) , or to a loading dose of 10 mg/kg tranexamic acid followed 2 h later by a continuous 2 mg/kg/h infusion for 20 h ( OD group , n = 52 ) .


The primary outcome was blood loss calculated from haematological values and perioperative transfusions .


Secondary outcomes included the occurrence of major complications within the first postoperative year .


All patients completed tranexamic acid therapy without adverse events .


The mean blood loss was 1,148 585 ml in group OS and 1,196 614 ml in group OD ( p = 0.68 ) .


No patients received a transfusion .


There were no occurrences of major complications up to 6-weeks follow-up .


The study demonstrated that a single bolus of tranexamic acid 30 mg/kg is as effective as a continuous infusion in patients undergoing tranexamic acid .


The single application of tranexamic acid as part of routine care is recommended .


To assess the efficacy of trabeculectomy with a biodegradable Ologen implant ( OLO ) versus mitomycin C ( MMC ) in patients in a prospective randomized clinical trial .


In the MMC group ( 15 patients ) , trabeculectomy was performed according to standard protocols .


In the OLO group ( 15 patients ) after standard trabeculectomy , the implant was positioned on top of the scleral flap , and no MMC was applied .


Mean preoperative intraocular pressure ( IOP ) levels ( OLO : 28.0 9.4 ; MMC : 23.9 5.0 mm Hg ; p = 0.21 ) and medication score ( OLO : 3.4 1.6 ; MMC : 3.6 1.5 ; p = 0.56 ) were comparable in both groups .


One year after surgery , the mean IOP was 15.9 4.5 mm Hg in the OLO group ( p < 0.01 , 43 % reduction ) and 11.0 2.6 mm Hg in the MMC group ( p < 0.01 , 54 % reduction ) .


The surgical success rate 12 months after surgery was 93.3 % in the MMC group and 40 % in the OLO group ( p = 0.01 ) .


With the atelocollagen-glycosaminoglycan matrix OLO it was not possible to reach the surgical success rate and pressure reduction achieved in the MMC group .


Serum matrix metalloproteinases ( MMP-8 , MMP-7 ) and their regulators may be associated with the risk of incident cardiovascular disease events .


Doxycycline can be used as matrix metalloproteinase ( MMP ) inhibitor independent of its antimicrobial activity .


We aimed to investigate serum inflammatory biomarkers during 4 months of doxycycline therapy in coronary bypass patients .


Thirty-one non-smoking men who had previous coronary bypass surgery were randomly assigned to receive placebo or 100 mg doxycycline daily for 4 months .


Serum samples were collected at baseline before the treatment , and at 2 , 4 , and 10 months .


Serum levels of MMP-7 , tissue inhibitor of matrix metalloproteinase ( TIMP ) -1 , myeloperoxidase , and neutrophil elastase were analyzed with enzyme-linked immunosorbent assay , MMP-8 by immunofluorometric assay , and C-reactive protein by rate nephelometry .


At baseline , no significant differences existed between the two groups .


Serum levels of MMP-8 , MMP-7 , and MMP-8 / TIMP-1 were and remained lower ( p = 0.034 , p = 0.041 , and NS ) in the doxycycline group relative to the placebo group at 4 months of follow-up .


Doxycycline decreases the systemic inflammatory burden in patients with myocardial infarction and especially down-regulates MMP-7 , MMP-8 , and MMP-8 / TIMP-1 .


Doxycycline might prevent or reduce the risk of secondary myocardial infarctions by providing a systemic anti-proteolytic and - inflammatory shield .


In epidemiologic research , incident chronic kidney disease ( CKD ) commonly is determined by laboratory tests performed at planned study visits .


Given the morbidity and mortality associated with CKD , persons with incident disease may be less likely to attend scheduled visits , affecting observed associations .


The objective of this study was to quantify loss to follow-up by CKD status and determine whether supplementation with diagnostic code data improves capture of incident CKD .


Prospective cohort study .


11,560 participants in the Atherosclerosis Risk in Communities ( ARIC ) Study underwent continuous surveillance for hospitalizations and death from baseline visit ( 1996-1999 ) to follow-up visit ( 2011-2013 ) .


A subset of hospitalizations in Washington County , MD , was used in diagnostic code validation ( n = 2,540 ) .


Baseline demographics and comorbid conditions .


Incident CKD stage 3 ascertained by follow-up visit ( visit-based definition ) or hospitalization surveillance ( hospitalization-based definition ) .


Visit-based definition : 25 % decline from baseline estimated glomerular filtration rate to < 60 mL/min/1 .73 m2 at follow-up visit ; hospitalization-based definition : hospitalization CKD diagnostic code .


Of 11,560 participants , 5,951 attended the follow-up visit and 9,264 were hospitalized .


Never-hospitalized participants were younger , more often female , and had fewer comorbid conditions ; 73.5 % attended the follow-up visit .


Incident CKD stage 3 occurred in 1,172 participants by the visit-based definition ( 251 were never hospitalized ) and 1,078 participants by the hospitalization-based definition ( 237 attended the follow-up study visit ) .


Sensitivity of the hospitalization-based CKD definition was 35.5 % ( 95 % CI , 31.6 % -39.7 % ) ; specificity was 95.7 % ( 95 % CI , 94.2 % -96.8 % ) .


Sensitivity was higher with later time period , older participant age , and baseline prevalent diabetes and CKD .


A subset of hospitalizations was used for validation ; 15-year gap between study visits .


The sensitivity of diagnostic code-identified CKD is low and varies by certain factors ; however , supplementing a visit-based definition with hospitalization information can increase disease identification during periods of follow-up without study visits .


We conducted this study with the aim of demonstrating the feasibility and efficacy of speed-feedback therapy with a bicycle ergometer on cognitive function in elderly cancer patients .


The subjects were patients with breast or prostate cancer who were 65years of age or over .


Among 146 patients , 78 were randomly assigned to the intervention group ( n = 38 ) or the control group ( n = 40 ) .


The intervention group received speed-feedback therapy with a bicycle ergometer once a week for four successive weeks .


The control group was advised to spend the 4-week period engaged in their routine activities .


Evaluations were carried out at the baseline and 4weeks after the baseline ( week 4 ) using the Frontal Assessment Battery , the Barthel Index , the Lawton and Brody Instrumental Activities of Daily Living , and the Functional Assessment of Cancer Therapy-General ver .4 .


Data were analyzed by a two-way repeated-measures analysis of variance .


The mean score of Frontal Assessment Battery for the intervention group was higher than that for the control group at week 4 .


In addition to significant main effects of time and group , we also found a significant interaction between the two groups ( p = 0.006 ) .


Moreover , all of the subjects in the intervention group could complete all the four sessions of therapy without any pain or distress .


These results suggest that speed-feedback therapy with a bicycle ergometer may be feasible as well as effective for improving the cognitive function in elderly cancer patients .


Problems with intravenous patient-controlled analgesia ( IV PCA ) are well known , including invasive route of delivery and pump programming errors .


The primary objective of this study was to evaluate patient satisfaction with a novel sublingual sufentanil PCA system ( sufentanil sublingual tablet system 15mcg with a 20-minute lockout interval ; SSTS ) to IV PCA morphine sulfate 1mg with a 6-minute lockout interval ( IV PCA MS ) for the management of acute postoperative pain .


This was a randomized , open-label , 48-hour non-inferiority study with optional extension to 72hours at 26 U.S. sites enrolling patients scheduled for elective major open abdominal or orthopedic ( hip or knee replacement ) surgery .


The primary outcome measure was the proportion of patients who responded `` good '' or `` excellent '' ( collectively `` success '' ) at the 48-hour timepoint on the Patient Global Assessment of method of pain control ( PGA48 ) .


A total of 357 patients received study drug and 78.5 % vs. 65.6 % of patients achieved PGA48 `` success '' for SSTS vs. IV PCA MS , respectively , demonstrating non-inferiority ( P < 0.001 using the one-side Z-test against the non-inferiority margin ) as well as statistical superiority for treatment effect ( P = 0.007 ) .


Patients using SSTS reported more rapid onset of analgesia and patient and nurse ease of care and satisfaction scores were higher than IV PCA MS. Adverse events were similar between the 2 groups ; however , SSTS had fewer patients experiencing oxygen desaturations below 95 % compared to IV PCA MS ( P = 0.028 ) .


Sufentanil sublingual tablet system is a promising new analgesic technology that may address some of the concerns with IV PCA .


As current dengue control strategies have been shown to be largely ineffective in reducing dengue in school-aged children , novel approaches towards dengue control need to be studied .


Insecticide-impregnated school uniforms represent an innovative approach with the theoretical potential to reduce dengue infections in school children .


This study took place in the context of a randomised control trial ( RCT ) to test the effectiveness of permethrin-impregnated school uniforms ( ISUs ) for dengue prevention in Chachoengsao Province , Thailand .


The objective was to assess the acceptability of ISUs among parents , teachers , and principals of school children involved in the trial .


Quantitative and qualitative tools were used in a mixed methods approach .


Class-clustered randomised samples of school children enrolled in the RCT were selected and their parents completed 321 self-administered questionnaires .


Descriptive statistics and logistic regression were used to analyse the quantitative data .


Focus group discussions and individual semi-structured interviews were conducted with parents , teachers , and principals .


Qualitative data analysis involved content analysis with coding and thematic development .


The knowledge and experience of dengue was substantial .


The acceptability of ISUs was high .


Parents ( 87.3 % ; 95 % CI 82.9-90 .8 ) would allow their child to wear an ISU and 59.9 % ( 95 % CI 53.7-65 .9 ) of parents would incur additional costs for an ISU over a normal uniform .


This was significantly associated with the total monthly income of a household and the educational level of the respondent .


Parents ( 62.5 % ; 95 % CI 56.6-68 .1 ) indicated they would be willing to recommend ISUs to other parents .


Acceptability of the novel tool of ISUs was high as defined by the lack of concern along with the willingness to pay and recommend .


Considering issues of effectiveness and scalability , assessing acceptability of ISUs over time is recommended .


To evaluate the efficacy and outcomes of PlasmaKinetic urethrotomy against cold knife direct vision internal urethrotomy in terms of recurrence rates .


A total of 136 male patients with urethral strictures were enrolled into the study .


The patients were allocated to cold knife or PlasmaKinetic urethrotomy groups sequentially by using computer-generated numbers .


Group A ( PlasmaKinetic ) and group B ( cold knife ) included 70 and 66 patients , respectively .


All patients were reevaluated at the 3rd , 9th and 18th month postoperatively with uroflowmetry .


Group A patients had a postoperative 3rd-month maximum flow rate value of 16.09 ml/s , whereas this same parameter was 15.15 ml/s in group B ( p < 0.05 ) .


The urethral stricture recurrence rate up to the 9-month period was statistically significant for group A ( 14 % ) compared with group B ( 30 % ) .


When we compared the recurrence rates of these groups from postoperative day 1 up to the 18th month , the results were 37 % for group A and 33 % for group B ( p > 0.05 ) .


PlasmaKinetic urethrotomy provides a better recurrence-free rate during the early period compared with conventional cold knife therapy .


Nevertheless , the outcome of the stricture did not change and fibrotic tissue reformed between the 9th and the 18th month .


This analysis evaluated HbA1c-adjusted hypoglycemia risk with glargine versus neutral protamine Hagedorn ( NPH ) over a 5-year study in patients with Type 2 diabetes mellitus ( T2DM ) .


Clinical significance was assessed using number needed to harm ( NNH ) to demonstrate the risk of one additional patient experiencing at least one hypoglycemic event .


Individual patient-level data for symptomatic documented hypoglycemia and HbA1c values from a 5-year randomized study comparing once-daily glargine ( n = 513 ) with twice-daily NPH ( n = 504 ) were analyzed .


Symptomatic hypoglycemia was categorized according to concurrent self-monitoring blood glucose levels and need for assistance .


Hypoglycemic events per patient-year as a function of HbA1c were fitted by negative binomial regression using treatment and HbA1c at endpoint as independent variables .


An estimate of NNH was derived from logistic regression models .


The cumulative number of symptomatic hypoglycemia events was consistently lower with glargine compared with NPH over 5years .


Compared with twice-daily NPH , once-daily glargine treatment resulted in significantly lower adjusted odds ratios ( OR ) for all daytime hypoglycemia ( OR 0.74 ; p = 0.030 ) and any severe event ( OR 0.64 ; p = 0.035 ) , representing a 26 % and 36 % reduction in the odds of daytime and severe hypoglycemia , respectively .


Our model predicts that , if 25 patients were treated with NPH instead of glargine , then one additional patient would experience at least one severe hypoglycemic event .


This analysis of long-term insulin treatment confirms findings from short-term studies and demonstrates that glargine provides sustained , clinically meaningful reductions in risk of hypoglycemia compared with NPH in patients with T2DM .


To develop a framework for integrating pharmacogenetics with clinical pharmacokinetics for personalized oxycodone dosing based on a patient 's CYP2D6 phenotype .


Randomized , crossover , double-blind , placebo-controlled .


Subjects were genotyped as CYP2D6 ultra-rapid metabolizer , extensive metabolizer , or poor metabolizer phenotypes .


Five subjects from each phenotype were randomly selected for inclusion in our study .


Studies were performed in silico .


The subjects were male , age 26 years , height 181.2 cm , and weight 76.3 kg .


They were healthy without comorbidities , and their medical examinations were normal .


The trajectories of phenotype-specific plasma oxycodone concentration-time profiles were analyzed using weighted nonlinear least-squares regression with WinSAAM software .


A global two-stage population-based model data analysis procedure was used to analyze the studies .


Clinical pharmacokinetics were calculated using the R package cpk , eliminating the need to perform hand-calculations .


Our study shows how clinicians can reduce risk and increase effectiveness for oxycodone dosing by ( 1 ) determining the patient 's likely metabolic response through testing a patient 's CYP2D6 phenotype , and ( 2 ) calculating clinical pharmacokinetics specific to the patient 's CYP2D6 phenotype to design a personalized oxycodone dosing regimen .


Personalized oxycodone dosing is a new tool for a clinician treating chronic pain patients requiring oxycodone .


By expressing a patient 's CYP2D6 phenotype pharmacokinetically , a clinician ( at least theoretically ) can improve the safety and efficacy of oxycodone and decrease the risk for iatrogenically induced overdose or death .


Pharmacokinomics provides a general framework for the integration of pharmacogenetics with clinical pharmacokinetics into clinical practice for gene-based prescribing .


New therapeutic options are needed for patients with psoriasis .


Tofacitinib , an oral Janus kinase inhibitor , is being investigated as a treatment for moderate-to-severe chronic plaque psoriasis .


In this study , we aimed to compare two tofacitinib doses with high-dose etanercept or placebo in this patient population .


In this phase 3 , randomised , multicentre , double-dummy , placebo-controlled , 12-week , non-inferiority trial , adult patients with chronic stable plaque psoriasis ( for 12 months ) who were candidates for systemic or phototherapy and had a Psoriasis Area and Severity Index ( PASI ) score of 12 or higher and a Physician 's Global Assessment ( PGA ) of moderate or severe , and had failed to respond to , had a contraindication to , or were intolerant to at least one conventional systemic therapy , were enrolled from 122 investigational dermatology centres worldwide .


Eligible patients were randomly assigned in a 3:3:3:1 ratio to receive tofacitinib 5 mg or 10 mg twice daily at about 12 h intervals , etanercept 50 mg subcutaneously twice weekly at about 3-4 day intervals , or placebo .


Randomisation was done by a computer-generated randomisation schedule , and all patients and study personnel were masked to treatment assignment .


The co-primary endpoints were the proportion of patients at week 12 with at least a 75 % reduction in the PASI score from baseline ( PASI75 response ) and the proportion of patients achieving a PGA score of `` clear '' or `` almost clear '' ( PGA response ) , analysed in the full analysis set ( all patients who were randomised and received at least one dose of study drug ) .


This study is registered with ClinicalTrials.gov , number NCT01241591 .


Between Nov 29 , 2010 , and Sept 13 , 2012 , we enrolled 1106 eligible adult patients with chronic plaque psoriasis and randomly assigned them to the four treatment groups ( 330 to tofacitinib 5 mg twice daily , 332 to tofacitinib 10 mg twice daily , 336 to etanercept 50 mg twice weekly , and 108 to placebo ) .


Of these patients , 1101 actually received their assigned study medication ( 329 in the tofactinib 5 mg group , 330 in the tofacitinib 10 mg group , 335 in the etanercept group , and 107 in the placebo group ) .


At week 12 , PASI75 responses were recorded in 130 ( 395 % ) of 329 patients in the tofacitinib 5 mg group , 210 ( 636 % ) of 330 in the tofacitinib 10 mg group , 197 ( 588 % ) of 335 in the etanercept group , and six ( 56 % ) of 107 in the placebo group .


A PGA response was achieved by 155 ( 471 % ) of 329 patients in the tofacitinib 5 mg group , 225 ( 682 % ) of 330 in the tofacitinib 10 mg group , 222 ( 663 % ) of 335 in the etanercept group , and 16 ( 150 % ) of 107 in the placebo group .


The rate of adverse events was similar across the four groups , with serious adverse events occurring in seven ( 2 % ) of 329 patients in the tofacitinib 5 mg group , five ( 2 % ) of 330 in the tofacitinib 10 mg group , seven ( 2 % ) of 335 in the etanercept group , and two ( 2 % ) of 107 in the placebo group .


Three ( 1 % ) of 329 patients in the tofacitinib 5 mg group , ten ( 3 % ) of 330 in the tofacitinib 10 mg group , 11 ( 3 % ) of 335 in the etanercept group , and four ( 4 % ) of 107 patients in the placebo group discontinued their assigned treatment because of adverse events .


In patients with moderate-to-severe plaque psoriasis , the 10 mg twice daily dose of tofacitinib was non-inferior to etanercept 50 mg twice weekly and was superior to placebo , but the 5 mg twice daily dose did not show non-inferiority to etanercept 50 mg twice weekly .


The adverse event rates over 12 weeks were similar for tofacitinib and etanercept .


This study indicates that in the future tofacitinib could provide a convenient and well-tolerated therapeutic option for patients with moderate-to-severe plaque psoriasis .


Pfizer Inc. .


This study examines the effect of progressive increases in footwear minimalism on injury incidence and pain perception in recreational runners .


One hundred and three runners with neutral or mild pronation were randomly assigned a neutral ( Nike Pegasus 28 ) , partial minimalist ( Nike Free 3.0 V2 ) or full minimalist shoe ( Vibram 5-Finger Bikila ) .


Runners underwent baseline testing to record training and injury history , as well as selected anthropometric measurements , before starting a 12-week training programme in preparation for a 10km event .


Outcome measures included number of injury events , Foot and Ankle Disability ( FADI ) scores and visual analogue scale pain rating scales for regional and overall pain with running .


99 runners were included in final analysis with 23 injuries reported ; the neutral shoe reporting the fewest injuries ( 4 ) and the partial minimalist shoe ( 12 ) the most .


The partial minimalist shoe reported a significantly higher rate of injury incidence throughout the 12-week period .


Runners in the full minimalist group reported greater shin and calf pain .


Running in minimalist footwear appears to increase the likelihood of experiencing an injury , with full minimalist designs specifically increasing pain at the shin and calf .


Clinicians should exercise caution when recommending minimalist footwear to runners otherwise new to this footwear category who are preparing for a 10km event .


To assess the clinical effect and safety of the Chinese medicine Longbishu Capsule combined with mesylate doxazosin in the treatment of benign prostatic hyperplasia ( BPH ) of the kidney deficiency and blood stagnation type .


This was a randomized , double-blind , double-simulation control study .


We equally assigned 60 men diagnosed with BPH of the kidney deficiency and blood stagnation type to an experimental and a control group , the former treated with mesylate doxazosin plus Longbishu Capsule and the latter with mesylate doxazosin plus placebo .


We compared the International Prostate Symptom Score ( IPSS ) , quality of life ( QOL ) , Chinese symptom score ( CSS ) , maximal urinary flow rate ( Qmax ) , and prostate volume between the two groups of patients before and after 6 months of medication .


After treatment , there were 5 cured cases , 13 markedly effective cases , 9 effective cases , 1 ineffective case , and 2 eliminated cases in the experimental group , as compared with 2 cured cases , 8 markedly effective cases , 10 effective cases , 7 ineffective cases , and 3 eliminated cases in the control group .


The total effectiveness rate was obviously higher in the former ( 96.4 % ) than in the latter ( 74.1 % ) .


IPSS , Qmax , and CSS were improved in both of the groups after medication , even more significantly in the experimental than in the control group ( IPSS : 15.22 2.98 vs 18.15 5.88 , P < 0.05 ; Qmax : [ 13.56 2.26 ] ml/s vs [ 11.78 2.97 ] ml/s , P < 0.05 ; CSS : 6.18 2.13 vs 9.52 3.15 , P < 0.05 ) .


Because of the difference in the QOL score between the two groups at the baseline ( P = 0.038 < 0.05 ) , no more comparison was made in this aspect after treatment .


The combination of Longbishu Capsule with mesylate doxazosin is safe and effective for the treatment of BPH .


Optimal management of knee osteoarthritis requires a combination of pharmacological and non-pharmacological methods .


The use of lateral wedge insoles to treat medial knee osteoarthritis is recommended , but there is still controversy about its efficacy .


The purpose of this study was to ascertain whether the use of lateral wedge insoles can diminish pain and improve function in patients with medial knee osteoarthritis .


Prospective randomized trial conducted in a tertiary-level hospital .


We prospectively enrolled 58 patients with medial knee osteoarthritis and randomized them to use either a lateral wedge insole with subtalar strapping ( Group W ) , or a neutral insole with subtalar strapping ( Group N - control ) .


All the patients were instructed to use the insole for five to ten hours per day .


A visual analogue pain scale , the Western Ontario and McMaster Universities Arthritis Index ( WOMAC ) and the Lequesne questionnaire were applied at baseline and at weeks 2 , 8 and 24 .


At weeks 8 and 24 , both groups showed lower scores for WOMAC ( P = 0,023 and P = 0,012 respectively ) .


There were no statistically significant differences between the groups regarding the visual analogue pain scale , WOMAC or Lequesne results at any time evaluated .


The use of a lateral wedge insole with subtalar strapping improved the patients ' symptoms and function but was not superior to placebo insoles .


The relation between the pattern of local anaesthetic ( LA ) spread and the quality of peripheral nerve block is unclear .


Twenty-one volunteers were randomized to receive a median nerve block with intended circumferential or intended non-circumferential spread of LA. .


Different predetermined volumes and needle placement techniques were used to produce the different patterns of LA spread .


Volumetric , multiplanar 3D ultrasound imaging was performed to evaluate the pattern and extent of LA spread .


Sensory block was assessed at predetermined intervals .


Complete circumferential spread of LA was achieved in only 67 % of cases in the intended circumferential study group and in 33 % of cases in the intended non-circumferential group .


Block success was similar ( 90 % ) and independent of whether circumferential or non-circumferential spread of the LA was achieved .


All block failures ( n = 4 ) occurred in the intended non-circumferential group with low volumes of LA. .


The onset of sensory block ( independent of group allocation ) was faster with circumferential spread of LA [ median ( IQR ) onset time , 15 ( 8 ; 20 ) min ] compared with non-circumferential spread of LA [ median ( IQR ) onset time , 20 ( 15 ; 30 ) min ] .


More LA was used for circumferential blocks [ median ( IQR ) volume of LA 2.8 ( 1.3 ; 3.6 ) vs 1.3 ( 1.1 ; 2.4 ) ml ] .


Even under optimal conditions , it was not possible to achieve circumferential spread of LA in all intended cases .


The success of median nerve block seems to be independent of the pattern of LA spread .


DRKS 00003826 .


The demand for long-term care for older adults has escalated sharply .


A good policy dedicated to the welfare of older adults has improved their quality of life .


The purpose of this study was to explore the social welfare utilization and needs of older adults and compare their differences among age groups , genders , and functional dependency levels .


Three hundred eighty-four stratified , random-sampled Taiwanese community-dwelling older adults were recruited for this survey research .


Participants rated their utilization of and needs for the 30 social welfare services provided by the government on a Likert-type scale .


The most widely used and needed social welfare services by the older adults were senior monetary stipend and a subsidy for the national health insurance premium .


Young-old , male , and functionally independent older adults had more knowledge of the social welfare services than their counterparts .


While designing a comprehensive social welfare system , differing needs of different age groups , genders , and functional dependency levels should be taken into consideration .


To evaluate the differences in the treatment outcomes between the unresectable and recurrent biliary tract cancer patients who received chemotherapy .


Patients who were treated with gemcitabine and S-1 combination therapy in the previous prospective studies were divided into groups of unresectable and recurrent cases .


The tumor response , time-to-progression , overall survival , toxicity , and dose intensity were compared between these two groups .


Response rate of the recurrent group was higher than that of the unresectable group ( 40.0 % vs 25.5 % ; P = 0.34 ) .


Median time-to-progression of the recurrent and unresectable groups were 8.7 mo ( 95 % CI ) , 1.2 mo , not reached ) and 5.7 mo ( 95 % CI : 4.0-7 .0 mo ) , respectively ( P = 0.14 ) .


Median overall survival of the recurrent and the unresectable groups were 16.1 mo ( 95 % CI : 2.0 mo-not reached ) and 9.6 mo ( 95 % CI : 7.1-11 .7 mo ) , respectively ( P = 0.10 ) .


Dose intensities were significantly lower in the recurrent groups ( gemcitabine : recurrent group 83.5 % vs unresectable group 96.8 % ; P < 0.01 , S-1 : Recurrent group 75.9 % vs unresectable group 91.8 % ; P < 0.01 ) .


Neutropenia occurred more frequently in recurrent group ( recurrent group 90 % vs unresectable group 55 % ; P = 0.04 ) .


Not only the efficacy but also the toxicity and dose intensity were significantly different between unresectable and recurrent biliary tract cancer .


Steroid-eluting spacers can improve local drug delivery immediately following endoscopic sinus surgery and reduce the recurrence of inflammation warranting systemic corticosteroids .


For chronic rhinosinusitis with nasal polyposis , the need for systemic corticosteroids immediately following endoscopic sinus surgery when using a steroid-eluting spacer has not been studied .


A randomized , double-blind , placebo-controlled trial .


Academic rhinology practice .


Chronic rhinosinusitis patients with nasal polyposis who failed medical therapy and elected endoscopic sinus surgery were enrolled .


Patients were randomized into either the treatment arm ( postoperative prednisone 30 mg daily 7 days ; n = 18 ) or placebo arm ( postoperative placebo pill daily 7 days ; n = 18 ) .


Outcomes were evaluated at 1 week , 3 weeks , and 2 months postoperatively .


Primary outcome was endoscopic grading at postoperative month 2 using the Lund-Kennedy system .


Secondary outcome included disease-specific quality of life using the Sinonasal Outcome Test ( SNOT-22 ) survey .


Patient enrollment occurred from January 2012 through February 2013 ( NCT01564355 ) .


Both arms received significant improvement in endoscopic grading and disease-specific quality of life from baseline compared to 2-month follow-up ( P < .001 ) .


There were no significant differences in mean endoscopic scores between the postoperative prednisone and control groups at 1 week ( P = .715 ) , 3 weeks ( P = .883 ) , or 2 months ( P = .343 ) .


There were no significant differences in SNOT-22 scores between groups at all follow-up points ( all P > .119 ) .


Minimizing systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyposis may avoid adverse events .


Results from this study suggest that postoperative systemic corticosteroids immediately following endoscopic sinus surgery may not provide improved outcomes when utilizing a steroid-eluting spacer .


To study the effects of lifestyle intervention in pregnancy on weight retention 6months postpartum among obese women from the `` Lifestyle in Pregnancy '' ( LiP ) study , and to determine associations between breastfeeding with postpartum maternal weight .


Six months postpartum follow up after a randomized controlled intervention trial .


Two university hospitals in Denmark .


A total of 360 women with pregestational body mass index 30kg/m ( 2 ) .


The intervention involved lifestyle changes ( diet and exercise ) during pregnancy .


The control group received routine pregnancy care .


Both groups received standard postnatal care .


Gestational weight gain , postpartum weight retention and breastfeeding .


Follow up was completed in 238 women of whom 46 % in the intervention group and 57 % in the control group had retained weight 6months postpartum ( p = 0.088 ) .


Women with gestational weight gain 9kg , ( recommended by the Institute of Medicine ) , retained less postpartum weight compared with those who exceeded 9kg ( median -0.7 vs. 1.5 , p < 0.001 ) .


Ninety-two percent in both weight gain groups initiated breastfeeding .


The number of breastfeeding mothers was higher among women with postpartum weight retention 5kg compared with those with weight retention > 5kg ( 94 % vs. 85 % , p = 0.034 ) .


We could not detect sustained weight control at 6months postpartum despite a lower gestational weight gain for obese women during pregnancy who received a lifestyle intervention rather than standard care .


Women who adhered to gestational weight gain recommendations had significantly lower postpartum weight retention .


Breastfeeding for 6months was negatively associated with postpartum weight retention .


The addition of trastuzumab ( T ) and lapatinib ( L ) to neoadjuvant chemotherapy increases the pathological complete response ( pCR ) rate in patients with human epidermal growth factor receptor 2 ( HER2 ) - positive early breast cancer .


We investigated the efficacy of T or L with neoadjuvant chemotherapy and specific efficacy biomarkers .


Patients with stages I-III ( including inflammatory ) HER2-positive breast cancer were randomised to receive epirubicin ( E ) plus cyclophosphamide ( C ) 4 cycles followed by docetaxel ( D ) plus either T ( EC-DT ) or L ( EC-DL ) .


End points included pCR ( primary ) , clinical response , toxicity , and pCR-predictive biomarkers .


We randomised 102 patients to EC-DT ( 50 ) and EC-DL ( 52 ) .


Median age was 48 , 56 % were premenopausal and 58 % had oestrogen receptor ( ER ) - positive tumours .


Pathological complete response in breast was 52.1 % ( 95 % CI :38.0 -66.2 % ) for EC-DT and 25.5 % ( 95 % CI :13.5 -37.5 % ) for EC-DL ( P = 0.0065 ) .


Pathological complete response in breast and axilla was 47.9 % for EC-DT and 23.5 % for EC-DL ( P = 0.011 ) .


Grade 3-4 toxicity did not differ across treatments , except for diarrhoea ( 2 % in EC-DT vs 13.5 % in EC-DL , P = 0.030 ) .


Multivariate analyses showed that treatment ( P = 0.036 ) and ER ( P = 0.014 ) were the only predictors of pCR in both groups .


EC-DT exhibited higher efficacy and lower toxicity than EC-DL .


Of the different biomarkers studied , only the absence of ER expression was associated with increased pCR .


Individuals treated with the cholesteryl ester transfer protein ( CETP ) inhibitor anacetrapib exhibit a reduction in both LDL cholesterol and apolipoprotein B ( ApoB ) in response to monotherapy or combination therapy with a statin .


It is not clear how anacetrapib exerts these effects ; therefore , the goal of this study was to determine the kinetic mechanism responsible for the reduction in LDL and ApoB in response to anacetrapib .


We performed a trial of the effects of anacetrapib on ApoB kinetics .


Mildly hypercholesterolemic subjects were randomized to background treatment of either placebo ( n = 10 ) or 20 mg atorvastatin ( ATV ) ( n = 29 ) for 4 weeks .


All subjects then added 100 mg anacetrapib to background treatment for 8 weeks .


Following each study period , subjects underwent a metabolic study to determine the LDL-ApoB-100 and proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) production rate ( PR ) and fractional catabolic rate ( FCR ) .


Anacetrapib markedly reduced the LDL-ApoB-100 pool size ( PS ) in both the placebo and ATV groups .


These changes in PS resulted from substantial increases in LDL-ApoB-100 FCRs in both groups .


Anacetrapib had no effect on LDL-ApoB-100 PRs in either treatment group .


Moreover , there were no changes in the PCSK9 PS , FCR , or PR in either group .


Anacetrapib treatment was associated with considerable increases in the LDL triglyceride/cholesterol ratio and LDL size by NMR .


These data indicate that anacetrapib , given alone or in combination with a statin , reduces LDL-ApoB-100 levels by increasing the rate of ApoB-100 fractional clearance .


ClinicalTrials.gov NCT00990808 .


Merck & Co. .


Inc. , Kenilworth , New Jersey , USA .


Additional support for instrumentation was obtained from the National Center for Advancing Translational Sciences ( UL1TR000003 and UL1TR000040 ) .


DISRUPT evaluated whether adding the vascular-disrupting agent ombrabulin to a taxane-platinum doublet in the first-line setting improved progression-free survival ( PFS ) in patients with metastatic non-small cell lung cancer ( NSCLC ) .


Patients were randomised to ombrabulin 35 mg/m ( 2 ) or placebo followed by a taxane-platinum regimen every 3 weeks .


Overall , 176 patients were randomised .


After 124 events , median PFS was not significantly improved with ombrabulin vs placebo ( 5.65 vs 5.45 months ; HR 0.948 ; 60 % CI 0.813-1 .106 ; one-sided P = 0.39 ) .


The two groups showed similar overall survival ( median 11.0 months in both groups ) , objective response rate ( 32 % ombrabulin ; 31 % placebo ) and safety profiles .


This study did not meet its primary endpoint of improving PFS by adding ombrabulin to a taxane-platinum regimen for first-line treatment of metastatic NSCLC .


Outcome monitoring feedback has become popular , but its effect on treatment outcome has been mixed .


Feedback seems most effective for patients who are not progressing well ( `` not on track '' ( NOT ) cases ) .


There are some indications that patient feedback has an additional effect and that feedback effects differentiate between short - and long-term therapy .


This study aimed to evaluate the effect of outcome monitoring feedback to therapists and patients on outcome in short - and long-term psychotherapy .


Patients ( n = 475 ) were randomly assigned to three conditions : Feedback to therapist ( FbT ) , feedback to therapist and patient ( FbTP ) , and no feedback ( NFb ) .


Feedback consisted of progress charts based on the Outcome Questionnaire and a feedback message .


In short-term therapies ( < 35 weeks ) FbT and FbTP was preventive of negative change for NOT cases .


In long-term therapy only FbTP had a small positive effect on the rate of change .


Feedback did not result in better outcomes at treatment ending , although there was a trend for FbTP to have fewer deteriorated cases .


Benefits of feedback were strongest for cases that were not progressing well in short-term therapies when both the patient and therapist received feedback on the patients ' progress .


Contrary to previous findings , we also found a small effect of feedback to therapists and patients in long-term therapies .


Feedback to both patients and therapists may be more effective than feedback to therapists alone due to implementation issues or empowerment of the patient .


Australian Aboriginal and Torres Strait Islander peoples ( Indigenous Australians ) smoke at much higher rates than non-Indigenous people and smoking is an important contributor to increased disease , hospital admissions and deaths in Indigenous Australian populations .


Smoking cessation programs in Australia have not had the same impact on Indigenous smokers as on non-Indigenous smokers .


This paper describes the outcome of a study that aimed to test the efficacy of a locally-tailored , intensive , multidimensional smoking cessation program .


A randomised controlled trial of Aboriginal researcher delivered tailored smoking cessation counselling during face-to-face visits , aiming for weekly for the first four weeks , monthly to six months and two monthly to 12 months .


The control ( `` usual care '' ) group received routine care relating to smoking cessation at their local primary health care service .


Data collection occurred at enrolment , six and 12 months .


The primary outcome was self-reported smoking cessation with urinary cotinine confirmation at final follow-up ( median 13 ( interquartile range 12-15 ) months after enrolment ) .


Participants in the intervention ( n = 55 ) and usual care ( n = 108 ) groups were similar in baseline characteristics , except the intervention group was slightly older .


At final follow-up the smoking cessation rate for participants assigned to the intervention group ( n = 6 ; 11 % ) , while not statistically significant , was double that of usual care ( n = 5 ; 5 % ; p = 0.131 ) .


A meta-analysis of these findings and a similarly underpowered but comparable study of pregnant Indigenous Australian women showed that Indigenous Australian participants assigned to the intervention groups were 2.4 times ( 95 % CI , 1.01-5 .5 ) as likely to quit as participants assigned to usual care .


Culturally appropriate , multi-dimensional Indigenous quit smoking programs can be successfully implemented in remote primary health care .


Intensive one-on-one interventions with substantial involvement from Aboriginal and Torres Strait Islander workers are likely to be effective in these settings .


Australian New Zealand Clinical Trials Registry ( ACTRN12608000604303 ) .


Desk-based office employees sit for most of their working day .


To address excessive sitting as a newly identified health risk , best practice frameworks suggest a multi-component approach .


However , these approaches are resource intensive and knowledge about their impact is limited .


To compare the efficacy of a multi-component intervention to reduce workplace sitting time , to a height-adjustable workstations-only intervention , and to a comparison group ( usual practice ) .


Three-arm quasi-randomized controlled trial in three separate administrative units of the University of Queensland , Brisbane , Australia .


Data were collected between January and June 2012 and analyzed the same year .


Desk-based office workers aged 20-65 ( multi-component intervention , n = 16 ; workstations-only , n = 14 ; comparison , n = 14 ) .


The multi-component intervention comprised installation of height-adjustable workstations and organizational-level ( management consultation , staff education , manager e-mails to staff ) and individual-level ( face-to-face coaching , telephone support ) elements .


Workplace sitting time ( minutes/8-hour workday ) assessed objectively via activPAL3 devices worn for 7 days at baseline and 3 months ( end-of-intervention ) .


At baseline , the mean proportion of workplace sitting time was approximately 77 % across all groups ( multi-component group 366 minutes/8 hours [ SD = 49 ] ; workstations-only group 373 minutes/8 hours [ SD = 36 ] , comparison 365 minutes/8 hours [ SD = 54 ] ) .


Following intervention and relative to the comparison group , workplace sitting time in the multi-component group was reduced by 89 minutes/8-hour workday ( 95 % CI = -130 , -47 minutes ; p < 0.001 ) and 33 minutes in the workstations-only group ( 95 % CI = -74 , 7 minutes , p = 0.285 ) .


A multi-component intervention was successful in reducing workplace sitting .


These findings may have important practical and financial implications for workplaces targeting sitting time reductions .


Australian New Zealand Clinical Trials Registry 00363297 .


Obesity is a pressing public health concern , which frequently presents in primary care .


With the explosive obesity epidemic , there is an urgent need to maximize effective management in primary care .


The 5As of Obesity Management ( 5As ) are a collection of knowledge tools developed by the Canadian Obesity Network .


Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable .


The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team ( 5AsT ) intervention to change provider behaviour .


The 5AsT trial is a theoretically informed , pragmatic randomized controlled trial with mixed methods evaluation .


Clinic-based multidisciplinary teams ( RN/NP , mental health , dietitians ) will be randomized to control or the 5AsT intervention group , to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation .


The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care .


Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners .


Evaluation will be informed by the RE-AIM framework .


The primary outcome measure , to which participants are blinded , is number of weight management visits/full-time equivalent ( FTE ) position .


Patient-level outcomes will also be assessed , through a longitudinal cohort study of patients from randomized practices .


Patient outcomes include clinical ( e.g. , body mass index [ BMI ] , blood pressure ) , health-related quality of life ( SF-12 , EQ5D ) , and satisfaction with care .


Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context , implementation and effectiveness of the 5AsT program .


The 5AsT trial will provide a wide range of insights into current practices , knowledge gaps and barriers that limit obesity management in primary practice .


The use of existing resources , collaborative design , practice facilitation , and integrated feedback loops cultivate an applicable , adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care .


NCT01967797 .


Both exercise and self-management are advocated in pulmonary rehabilitation for people with chronic obstructive pulmonary disease ( COPD ) .


The widely used 6-week , group-based Chronic Disease Self-Management Program ( CDSMP ) increases self-reported exercise , despite supervised exercise not being a program component .


This has been little explored in COPD .


Whether adding supervised exercise to the CDSMP would add benefit is unknown .


We investigated the CDSMP in COPD , with and without a formal supervised exercise component , to address this question .


Adult outpatients with COPD were randomized to the CDSMP with or without one hour of weekly supervised exercise over 6 weeks .


The primary outcome measure was 6-minute walk test distance ( 6MWD ) .


Secondary outcomes included self-reported exercise , exercise stage of change , exercise self-efficacy , breathlessness , quality of life , and self-management behaviors .


Within - and between-group differences were analyzed on an intention-to-treat basis .


Of 84 subjects recruited , 15 withdrew .


6MWD increased similarly in both groups : CDSMP-plus-exercise ( intervention group ) by 18.646.2 m ; CDSMP-alone ( control group ) by 20.046.2 m.


There was no significant difference for any secondary outcome .


The CDSMP produced small statistically significant increase in 6MWD .


The addition of a single supervised exercise session did not further increase exercise capacity .


Our findings confirm the efficacy of a behaviorally based intervention in COPD , but this would seem to be less than expected from conventional exercise-based pulmonary rehabilitation , raising the question of how , if at all , the small gains observed in this study may be augmented .


To assess the effectiveness of a habit-based intervention delivered by e-mail or sms in improving fruit and vegetable consumption among young adults .


An eight-week randomised controlled trial compared the effectiveness of three different types of message content ( habit-based messages ; food-group messages ; general healthy eating messages ) and two delivery methods ( e-mail versus sms ) on habit strength and consumption of fruits and vegetables in 71 undergraduate participants .


A significant message content by time interaction indicated that the habit-based intervention improved fruit consumption over the eight-week period .


Vegetable consumption significantly increased over the intervention period regardless of message content .


Delivery method did not influence these results .


Messages based on a habit framework can be utilised to improve fruit consumption in young adults .


Furthermore , simply reminding young adults to be conscious of their food choices may be sufficient to improve their overall vegetable consumption .


To evaluate the safety and efficacy of tadalafil on demand and on time in men with erectile dysfunction .


We conducted a multi-centered randomized controlled study on 120 ED males , who were assigned to take tadalafil at 10 mg / 20 mg on demand before sexual activity and at the same dose on time twice a week for 8 weeks .


Before and at 4 and 8 weeks after treatment , and 1 month after withdrawal , we obtained the scores on IIEF-5 , ED Inventory of Treatment Satisfaction ( EDITS ) and the short form of Psychological and Interpersonal Relationship Scales ( SF-PAIRS ) , and compared the safety and efficacy of medication between the two groups of patients .


Totally , 110 patients accomplished the trial , 56 in the on-time and 54 in the on-demand group .


At 4 and 8 weeks of medication and 1 month after withdrawal , the IIEF-5 scores were improved in both the on-time and on-demand groups , even more significantly in the former than in the latter at 8 weeks of treatment ( 21.6 + / - 2.9 vs 18.5 + / - 1.7 ) and 1 month after withdrawal ( 20.9 + / - 2.1 vs 17.9 + / - 2.3 ) ( P < 0.05 ) .


The EDITS scores were significantly higher in the on-time than in the on-demand group at 8 weeks of treatment ( 31.7 + / - 6.9 vs 28.6 + / - 5.8 ) and 1 month after withdrawal ( 30.6 + / - 4.7 vs 27.9 + / - 6.5 ) ( P < 0.05 ) .


The scores on the sexual self-confidence , spontaneity and time-concern domains of SF-PAIRS were remarkably improved after medication as compared with the baseline ( P < 0.05 ) , even more significantly in the on-time than in the on-demand group at 1 month after withdrawal .


Both dosing schedules were well tolerated and no significant differences were observed in safety between the two groups .


On-time dosing of tadalafil is efficacious and well tolerated in the treatment of ED , and has an even better effect than on-demand dosing at 8 weeks of medication and 1 month after withdrawal .


Lasers have been extensively used in dentistry for several applications .


We investigated and compared the use of an erbium : yttrium-aluminum-garnet laser and conventional rotary instruments for bone removal in third molar surgery .


We implemented a randomized , split-mouth clinical trial .


Patients with bilateral and symmetrical third molar impaction referred to the Department of Oral and Maxillo-Facial Sciences , `` Sapienza '' University of Rome , were enrolled in the study .


Each patient was treated once with the erbium : yttrium-aluminum-garnet laser and once with conventional rotary instruments for bone removal during third molar surgery .


Pain , swelling , and trismus were taken into account to match the 2 techniques.In addition , the times required to complete osteotomy and for the full operation were recorded .


Descriptive and bivariate statistics were computed , and the P value was set at .05 .


The sample was composed of 15 patients ( 8 men and 7 women ) ranging in age from 18 to 30 years .


Pain perceived in the laser-treated group was significantly less than that in the conventional group ( P = .0013 ) .


This also was true for trismus ( P = .0002 ) and swelling .


The operating time for osteotomy was longer in the laser group .


The results of this study suggest that the laser could be an interesting alternative to conventional rotary instruments .


Future studies with a larger number of patients are required to confirm the conclusions achieved from this work .


Home care workers are a high-risk group for injury and illness .


Their unique work structure presents challenges to delivering a program to enhance their health and safety .


No randomized controlled trials have assessed the impact of a Total Worker Health program designed for their needs .


The COMPASS ( COMmunity of Practice And Safety Support ) study is a cluster randomized trial being implemented among Oregon 's unionized home care workers .


Partnering with the Oregon Home Care Commission allowed recruiting 10 pairs of home care worker groups with 8 participants per group ( n = 160 ) for balanced randomization of groups to intervention and control conditions .


Physiologic and survey evaluation of all participants will be at enrollment , 6 months and 12 months .


Primary outcomes are to increase health promoting ( for example , healthy nutrition and regular physical activity ) and health protecting ( that is , safety ) behaviors .


In addition to assessing outcomes adjusted for the hierarchical design , mediation analyses will be used to deconstruct and confirm the program 's theoretical underpinnings and intervention processes .


Intervention groups will participate in a series of monthly 2-hour meetings designed as ritualized , scripted peer-led sessions to increase knowledge , practice skills and build support for healthy actions .


Self-monitoring and individual and team level goals are included to augment change .


Because generalizability , reach and achieving dissemination are priorities , following initial wave findings , a second wave of COMPASS groups will be recruited and enrolled with tailoring of the program to align with existing Home Care Commission educational offerings .


Outcomes , process and mediation of those tailored groups will be compared with the original wave 's findings .


The COMPASS trial will assess a novel program to enhance the safety and health of a vulnerable , rapidly expanding group of isolated caregivers , whose critical work allows independent living of frail seniors and the disabled .


ClinicalTrials.gov identifier : NCT02113371 , first registered 11 March 2014 .


Many patients with Parkinson 's disease have motor fluctuations despite treatment with available drugs .


Tozadenant ( SYN115 ) is an oral , selective adenosine A2A receptor antagonist that improves motor function in animal models of Parkinson 's disease .


We aimed to assess the safety and efficacy of tozadenant as an adjunct to levodopa in patients with Parkinson 's disease who have motor fluctuations on levodopa .


We did an international , multicentre , phase 2b , randomised , double-blind , placebo-controlled , parallel-group , dose-finding clinical trial of tozadenant in levodopa-treated patients with Parkinson 's disease who had motor fluctuations ( at least 25 h off-time per day ) .


Eligible patients were randomly assigned via a computer-generated randomisation schedule to receive tozadenant 60 , 120 , 180 , or 240 mg or matching placebo twice daily for 12 weeks .


All study management , site personnel , and patients were masked to treatment assignment .


The primary outcome was change from baseline to week 12 in hours per day spent in the off-state ( assessed from Parkinson 's disease diaries completed by patients ) .


This study is registered at ClinicalTrials.gov , number NCT01283594 .


Of 420 randomised patients ( mean age 633 [ SD 83 ] years ; mean duration of Parkinson 's disease 87 [ 47 ] years ) , 403 provided post-baseline diary data and 337 completed study treatment .


Compared with placebo , mean daily off-time was significantly reduced in the combined tozadenant 120 mg twice-daily and 180 mg twice-daily group ( -11 h , 95 % CI -18 to -05 ; p = 00006 ) , the tozadenant 120 mg twice-daily group ( -11 h , -18 to -04 ; p = 0.0039 ) , and the tozadenant 180 mg twice-daily group ( -12 h , -19 to -04 ; p = 00039 ) .


The most common adverse events in these groups were dyskinesia ( seven [ 8 % ] of 84 patients in the placebo group , 13 [ 16 % ] of 82 in the 120 mg twice-daily group , and 17 [ 20 % ] of 85 in the 180 mg twice-daily group ) , nausea ( three [ 4 % ] , 9 [ 11 % ] , and ten [ 12 % ] ) , and dizziness ( one [ 1 % ] , four [ 5 % ] , and 11 [ 13 % ] ) .


Tozadenant 60 mg twice daily was not associated with a significant reduction in off-time , and tozadenant 240 mg twice daily was associated with an increased rate of discontinuation because of adverse events ( 17 [ 20 % ] of 84 patients ) .


Tozadenant at 120 or 180 mg twice daily was generally well tolerated and was effective at reducing off-time .


Further investigation of tozadenant treatment in phase 3 trials is warranted .


Biotie Therapies .


To assess the effects of the RHANI ( Reducing HIV among Non-Infected ) Wives intervention on marital conflict and intimate partner violence ( IPV ) in urban India .


A 2-armed cluster-randomized controlled trial ( 7 intervention , 6 control clusters ) of the RHANI Wives intervention was conducted with 220 women contending with a history of IPV and/or husband 's drunken behavior .


Participants were surveyed at baseline and 4.5-month follow-up .


Outcome measures included marital conflict ( arguments with husband in past 3 months ) , marital IPV ( physical or sexual violence from husband in past 3 months ) , and marital sexual coercion ( husband forcing sex at last sex ) .


Intention-to-treat logistic generalized linear mixed models were used to determine intervention impact .


One-third ( 35.0 % ) of participants reported physical or sexual abuse from their husband in the past 3 months , and 58.6 % reported that their husband was drunk in the past 30 days .


Intention-to-treat analyses indicated timetreatment reductions in marital conflict ( risk ratio [ RR ] 0.4 ; 90 % confidence interval [ CI ] , 0.1-0 .9 ; P = 0.06 ) and marital sexual coercion ( RR 0.2 ; 90 % CI , 0.05-0 .9 ; P = 0.08 ) , but not IPV .


The findings suggest the potential utility of this intervention in reducing marital conflict and sexual coercion among women in urban India .


ClinicalTrials.gov : NCT01592994 .


Mineralocorticoid receptor antagonists reduce morbidity and mortality in patients with heart failure but can cause hyperkalemia , which contributes to reduced use of these drugs .


Hypokalemia also leads to worse outcomes in patients with heart failure and may be attenuated by mineralocorticoid receptor antagonists .


We assessed incidence and predictors of hyperkalemia ( potassium 5.5 mmol/L ) and hypokalemia ( potassium < 3.5 mmol/L ) and the relationship to outcomes in 1663 patients with class III or IV heart failure and left ventricular ejection fraction < 35 % randomized to treatment with spironolactone 25 mg or placebo in the Randomized Aldactone Evaluation Study ( RALES ) trial .


All-cause mortality rates and the influence of potassium levels on the effectiveness of spironolactone were assessed in a landmark analysis and in relation to time-varying potassium levels .


After 1 month , mean potassium levels increased in the spironolactone group but not in the placebo group ( 4.540.49 versus 4.280.50 mmol/L ; P < 0.001 ) and remained elevated during the trial .


Although the extremes of hypokalemia and hyperkalemia at 4 weeks were associated with increased risk of mortality in both treatment arms , participants in the spironolactone arm had lower mortality rates at all potassium levels throughout the duration of the trial .


The treatment benefit of spironolactone was maintained at least until potassium exceeded 5.5 mmol/L .


With appropriate surveillance of potassium and creatinine , the use of spironolactone was associated with less hypokalemia and improved survival in patients with severe heart failure even in the setting of moderate hyperkalemia .


To investigate the effects of a multifaceted implementation strategy on behaviour , behavioural determinants , knowledge and awareness of healthcare workers regarding the use of recommendations to prevent hand eczema .


The Hands4U study is a randomised controlled trial .


A total of 48 departments ( n = 1649 workers ) were randomly allocated to the multifaceted implementation strategy or the control group ( minimal implementation strategy ) .


Within the departments designated to the multifaceted implementation strategy , participatory working groups were set up to enhance the implementation of the recommendations for hand eczema .


In addition , working group members were trained to become role models , and an education session was given within the department .


Outcome measures were awareness , knowledge , receiving information , behaviour and behavioural determinants .


Data were collected at baseline , with a 3 - and 6-month follow-up .


Statistically significant effects were found after 6months for awareness ( OR 6.30 ; 95 % CI 3.41 to 11.63 ) , knowledge ( B 0.74 ; 95 % CI 0.54 to 0.95 ) , receiving information ( OR 9.81 ; 95 % CI 5.60 to 17.18 ) , washing hands ( B -0.40 ; 95 % -0.51 to -0.29 ) , use of moisturiser ( B 0.29 ; 95 % CI 0.20 to 0.38 ) , cotton under gloves ( OR 3.94 ; 95 % CI 2.04 to 7.60 ) and the overall compliance measure ( B 0.14 ; 95 % CI 0.02 to 0.26 ) , as a result of the multifaceted implementation strategy .


No effects were found for behavioural determinants .


The multifaceted implementation strategy can be used in healthcare settings to enhance the implementation of recommendations for the prevention of hand eczema .


NTR2812 .


To examine the effects of pretreatment with diquafosol 3.0 % ophthalmic solution on corneal surface wetting during cataract surgery with intraocular lens ( IOL ) implantation in cases of senile cataract .


Shohzankai Medical Foundation , Miyake Eye Hospital , Nagoya , Japan .


Prospective randomized single-masked comparative study .


Phacoemulsification and IOL implantation were performed in eyes with senile cataract .


After a 2-week washout period , patients were randomly assigned to receive 1 drop of diquafosol 3.0 % ophthalmic solution or artificial tears 6 times daily for 4 weeks before surgery .


The main outcome measure , termed the corneal wetting property , was the time between when a clear image of the operating microscope light source appeared just after the corneal surface was irrigated with a balanced salt solution and the time at which that image began to blur .


The study enrolled 51 patients ( 76 eyes ) .


The mean time to corneal wetting was 50.1 seconds 10.8 ( SD ) in the diquafosol group and 45.3 9.2 seconds in the artificial tears group .


The difference between the 2 groups was statistically significant ( P < .029 ) .


Four-week pretreatment with diquafosol 3.0 % ophthalmic solution in patients with senile cataract scheduled for cataract surgery with IOL implantation was effective in enhancing the intraoperative corneal surface wetting property , which suggests improved optical clarity during surgery .


No author has a financial or proprietary interest in any material or method mentioned .


This randomised , double-blind , 12-week study compared efficacy and tolerability of flexible-dose treatment with vortioxetine ( 10-20 mg/day ) versus agomelatine ( 25-50 mg/day ) in major depressive disorder patients with inadequate response to selective serotonin reuptake inhibitor ( SSRI ) / serotonin-noradrenaline reuptake inhibitor ( SNRI ) monotherapy .


Patients were switched directly from SSRI/SNRI to vortioxetine or agomelatine .


Primary endpoint was change from baseline to week 8 in the Montgomery-sberg Depression Rating Scale ( MADRS ) total score analysed by mixed model for repeated measurements , using a noninferiority test followed by a superiority test .


Secondary endpoints included response and remission rates , anxiety symptoms ( Hamilton Anxiety Rating Scale ) , Clinical Global Impression , overall functioning ( Sheehan Disability Scale ) , health-related quality of life ( EuroQol 5 Dimensions ) , productivity ( work limitation questionnaire ) and family functioning ( Depression and Family Functioning Scale ) .


Primary endpoint noninferiority was established and vortioxetine ( n = 252 ) was superior to agomelatine ( n = 241 ) by 2.2 MADRS points ( p < 0.01 ) .


Vortioxetine was also significantly superior in response and remission rates at weeks 8 and 12 ; MADRS , Hamilton Anxiety Rating Scale , Clinical Global Impression , Sheehan Disability Scale and EuroQol 5 Dimensions scores at week 4 onwards ; work limitation questionnaire at week 8 and Depression and Family Functioning Scale at weeks 8 and 12 .


Fewer patients withdrew because of adverse events with vortioxetine ( 5.9 % vs 9.5 % ) .


Adverse events ( incidence 5 % ) were nausea , headache , dizziness and somnolence .


Vortioxetine was noninferior and significantly superior to agomelatine in major depressive disorder patients with previous inadequate response to a single course of SSRI/SNRI monotherapy .


Vortioxetine was safe and well tolerated .


Women with breast cancer experience different symptoms related to surgical or adjuvant therapy .


Previous findings and theoretical models of mind-body interactions suggest that psychological wellbeing , i.e. levels of distress , influence the subjective evaluation of symptoms , which influences or determines functioning .


The eight-week mindfulness-based stress reduction ( MBSR ) program significantly reduced anxiety and depression in breast cancer patients in a randomized controlled trial ( NCT00990977 ) .


In this study we tested the effect of MBSR on the burden of breast cancer related somatic symptoms , distress , mindfulness and spiritual wellbeing and evaluated possible effect modification by adjuvant therapy and baseline levels of , distress , mindfulness and spiritual wellbeing .


A population-based sample of 336 women Danish women operated for breast cancer stages I-III were randomized to MBSR or usual care and were followed up for somatic symptoms , distress , mindfulness skills and spiritual wellbeing post-intervention and after six and 12 months .


Effect was tested by general linear regression models post-intervention , and after six and 12 months follow-up and by mixed effects models for repeated measures of continuous outcomes .


Effect size ( Cohen 's d ) was calculated to explore clinical significance of effects among intervention group .


Finally , modification of effect of MBSR on burden of somatic symptoms after 12 months ' follow-up by adjuvant therapy and baseline levels of , distress , mindfulness and spiritual wellbeing were estimated .


General linear regression showed a significant effect of MBSR on the burden of somatic symptoms post-intervention and after 6 months ' follow-up .


After 12 months ' follow-up , no significant effect of MBSR on the burden of somatic symptoms was found in mixed effect models .


A statistically significant effect of MBSR on distress was found at all time-points and in the mixed effect models .


Significant effects on mindfulness were seen after six and 12 months and no significant effect was observed for spiritual wellbeing .


No significant modification of MBSR effect on somatic symptom burden was identified .


This first report from a randomized clinical trial on the long-term effect of MBSR finds an effect on somatic symptom burden related to breast cancer after six but not 12 months follow-up providing support for MBSR in this patient group .


Although the addition of the HCV NS3/4A protease inhibitors boceprevir and telaprevir to pegylated interferon ( peginterferon ) alfa plus ribavirin has improved sustained virological response ( SVR ) in treatment-naive and treatment-experienced patients infected with hepatitis C virus ( HCV ) genotype 1 , the regimens have a high pill burden and are associated with increased rates and severity of adverse events , such as anaemia and rash .


The efficacy and safety of the combination of simeprevir , a one pill , once-daily , oral HCV NS3/4A protease inhibitor , plus peginterferon alfa 2a plus ribavirin were assessed in treatment-naive patients with HCV genotype 1 infection .


In QUEST-1 , a phase 3 , randomised , double-blind multicentre trial undertaken in 13 countries ( Australia , Europe , North America , Puerto Rico , and New Zealand ) , 394 patients ( aged 18 years ) with chronic HCV genotype 1 infection and no history of HCV treatment , stratified by HCV subtype and host IL28B genotype , were randomly assigned in a 2:1 ratio with a computer-generated allocation sequence to receive simeprevir ( 150 mg once daily , orally ) plus peginterferon alfa 2a plus ribavirin for 12 weeks , followed by peginterferon alfa 2a plus ribavirin ( simeprevir group ) , or placebo orally plus peginterferon alfa 2a plus ribavirin for 12 weeks , followed by peginterferon alfa 2a plus ribavirin ( placebo group ) .


Treatment duration was 24 weeks or 48 weeks in the simeprevir group according to criteria for response-guided therapy ( ie , HCV RNA < 25 IU/mL [ undetectable or detectable ] at week 4 and < 25 IU/mL undetectable at week 12 ) and 48 weeks in the placebo group .


Patients , study personnel , and the sponsor were masked to the treatment group assignment .


The primary efficacy endpoint was sustained virological response 12 weeks after the planned end of treatment ( SVR12 ) and was assessed with an intention-to-treat analysis .


The results of the primary analysis ( week 60 ) are presented for safety and SVR12 .


This trial is registered with ClinicalTrials.gov , number NCT01289782 .


Treatment with simeprevir , peginterferon alfa 2a , and ribavirin was superior to placebo , peginterferon alfa 2a , and ribavirin ( SVR12 in 210 [ 80 % ] patients of 264 vs 65 [ 50 % ] of 130 , respectively , adjusted difference 293 % [ 95 % CI 201-386 ; p < 00001 ) .


Adverse events in the first 12 weeks of treatment led to discontinuation of simeprevir in two ( < 1 % ) patients and discontinuation of placebo in one patient ( < 1 % ) ; fatigue ( 106 [ 40 % ] vs 49 [ 38 % ] patients , respectively ) and headache ( 81 [ 31 % ] vs 48 [ 37 % ] , respectively ) were the most common adverse events .


The prevalences of anaemia ( 42 [ 16 % ] vs 14 [ 11 % ] , respectively ) and rash ( 72 [ 27 % ] vs 33 [ 25 % ] ) were similar in the simeprevir and placebo groups .


Addition of simeprevir did not increase severity of patient-reported fatigue and functioning limitations , but shortened their duration .


Simeprevir once daily with peginterferon alfa 2a and ribavirin shortens therapy in treatment-naive patients with HCV genotype 1 infection without worsening the adverse event profiles associated with peginterferon alfa 2a plus ribavirin .


Janssen Infectious Diseases-Diagnostics .


Depression , anxiety , and fatigue are among the most significant problems that influence the quality of life of patients with breast cancer who receive adjuvant chemotherapy .


Although evidence has shown yoga to decrease anxiety , depression , and fatigue in patients with cancer , few studies on the effects of yoga have targeted patients with breast cancer .


Yoga interventions should be tested to promote the psychological and physical health of women with breast cancer .


This study examines the effectiveness of an 8-week yoga exercise program in promoting the psychological and physical health of women with breast cancer undergoing adjuvant chemotherapy in terms of depression , anxiety , and fatigue .


A sample of 60 women with nonmetastatic breast cancer was recruited .


Participants were randomly assigned into either the experimental group ( n = 30 ) or the control group ( n = 30 ) .


A 60-minute , twice-per-week yoga exercise was implemented for 8 weeks as the intervention for the participants in the experimental group .


The control group received standard care only .


Analysis using the Johnson-Neyman procedure found that the yoga exercise reduced overall fatigue and the interference of fatigue in everyday life for the experimental group participants .


Significant reductions were obtained after 4 weeks of intervention participation for those experimental group patients with relatively low starting baseline values ( baseline item mean value < 3.31 and 3.22 , respectively ) and after 8 weeks for most patients ( approximately 75 % ) with moderate starting baseline values ( baseline item mean value < 7.30 and 5.34 , respectively ) .


The 8-week intervention did not significantly improve the levels of depression ( F = 1.29 , p > .05 ) or anxiety ( F = 2.7 , p > .05 ) .


The 8-week yoga exercise program developed in this study effectively reduced fatigue in patients with breast cancer but did not reduce depression or anxiety .


Oncology nurses should strengthen their clinical health education and apply yoga to reduce the fatigue experienced by patients with breast cancer who undergo adjuvant chemotherapy .


Different types of carbohydrates have diverse glycemic response , thus glycemic index ( GI ) and glycemic load ( GL ) are used to assess this variation .


The impact of dietary GI and GL in all-cause mortality is unknown .


The objective of this study was to estimate the association between dietary GI and GL and risk of all-cause mortality in the PREDIMED study .


The PREDIMED study is a randomized nutritional intervention trial for primary cardiovascular prevention based on community-dwelling men and women at high risk of cardiovascular disease .


Dietary information was collected at baseline and yearly using a validated 137-item food frequency questionnaire ( FFQ ) .


We assigned GI values of each item by a 5-step methodology , using the International Tables of GI and GL Values .


Deaths were ascertained through contact with families and general practitioners , review of medical records and consultation of the National Death Index .


Cox regression models were used to estimate multivariable-adjusted hazard ratios ( HR ) and their 95 % CI for mortality , according to quartiles of energy-adjusted dietary GI/GL .


To assess repeated measures of exposure , we updated GI and GL intakes from the yearly FFQs and used Cox models with time-dependent exposures .


We followed 3,583 non-diabetic subjects ( 4.7 years of follow-up , 123 deaths ) .


As compared to participants in the lowest quartile of baseline dietary GI , those in the highest quartile showed an increased risk of all-cause mortality [ HR = 2.15 ( 95 % CI : 1.15-4 .04 ) ; P for trend = 0.012 ] .


In the repeated-measures analyses using as exposure the yearly updated information on GI , we observed a similar association .


Dietary GL was associated with all-cause mortality only when subjects were younger than 75 years .


High dietary GI was positively associated with all-cause mortality in elderly population at high cardiovascular risk .


The aim of this study was to investigate the safety and efficacy of dalteparin during an elective percutaneous coronary intervention ( PCI ) procedure in a large cohort .


In this prospective , randomized , open-label design study , 733 patients undergoing elective PCI were divided into an unfractionated heparin group ( group 1 , 323 patients ) or a dalteparin group ( group 2 , 410 patients ) .


Blood samples were collected before and 18-24 h after the PCI procedure to determine the serum levels of cardiac troponin I ( cTnI ) and creatine kinase isoenzyme MB .


Major adverse cardiac events ( MACEs ) and bleeding events during hospitalization were also recorded .


Patients with an increased level of serum cTnI before PCI were excluded from the study .


After PCI , the cTnI values were greater than three times the upper limit of normal in 43 cases ( 13.3 % ) in group 1 and 52 cases ( 12.7 % ) in group 2 , without a statistically significant difference between the two groups ( P = 0.801 ) .


An increased creatine kinase isoenzyme MB level of greater than two times the upper limit of normal was found in 10 cases ( 3.1 % ) in group 1 and 12 cases ( 2.9 % ) in group 2 , without a statistically significant difference between the two groups ( P = 0.894 ) .


Postoperative bleeding was observed in nine patients ( 2.8 % ) in group 1 and six patients ( 1.5 % ) in group 2 .


Postoperative MACEs were observed in two patients ( 0.6 % ) in group 1 and two patients ( 0.5 % ) in group 2 .


There were no significant differences between the two groups with respect to bleeding events or MACEs .


Our study showed that dalteparin might be as effective and safe as unfractionated heparin for anticoagulation during elective PCI .


In patients with asthma , single doses of inhaled glucocorticosteroids ( ICS ) have been reported to have antiinflammatory actions that can be detected several hours after drug administration .


However , the onset and duration of the effect have not been investigated .


We therefore measured airway blood flow ( [ Formula : see text ] aw ) as an index of airway inflammation to determine the time course and dose dependence of the antiinflammatory action of an ICS in 20 patients with moderate asthma receiving regular ICS treatment .


[ Formula : see text ] aw and spirometry were measured before and serially for 360 minutes after a single inhaled dose of 360 g , 720 g , and 1,440 g budesonide or placebo as well as after four repetitive 720-g budesonide doses given 30 minutes apart .


Baseline mean [ Formula : see text ] aw was increased and FEV1 was decreased without significant differences among the 5 treatment days .


After budesonide inhalation , there was a transient , dose-dependent decrease in mean [ Formula : see text ] aw from 12 to 21 % , with significant differences from baseline at 60 and 90 minutes for the 720-g and 1,440-g doses ( P < 0.05 ) .


Thirty minutes after four repetitive budesonide administrations , mean [ Formula : see text ] aw was 28 % below baseline ( P < 0.05 ) and remained 11 % below baseline after 270 minutes .


There was no change in mean FEV1 after any of the treatments .


In subjects with moderate asthma who use ICS regularly , inhaled budesonide caused a transient dose-dependent vasoconstriction in the airway , thereby reversing one manifestation of airway inflammation .


These results suggest that a pure controller medication can have immediate beneficial effects not paralleled by changes in airflow .


Clinical trial registered with www.clinicaltrials.gov ( NCT 01219738 ) .


No immunogenicity data has been reported after a single dose of the quadrivalent HPV vaccine ( qHPV-Gardasil ) and no data are available on co-administration of this vaccine with the HAV/HBV vaccine ( Twinrix-Junior ) .


Two pre-licensure studies reported similar anti-HPV but lower anti-HBs titers when co-administering HPV and HBV vaccines .


To assess the immunogenicity of the qHPV and HAV/HBV vaccine when co-administered ( Group-Co-adm ) or given one month apart ( Group-Sep ) and to measure the persistence of HPV antibodies three years post-second dose of qHPV vaccine in both study groups .


416 9-10 year-old girls were enrolled .


Vaccination schedule was 0-6 months .


Anti-HAV and anti-HBs were measured in all subjects 6 months post-first dose and 1 month post-second dose .


Anti-HPV were measured 6 months post-first dose in Group-Co-adm and in all subjects 1 and 36 months post-second dose .


Six months post-first dose : 100 % of subjects had detectable anti-HAV and 56 % and 73 % had detectable anti-HBs in Group-Co-Adm and Group-Sep , respectively .


In Group-Co-adm 94 , 100 , 99 and 96 % had detectable antibodies to HPV 6 , 11 , 16 and 18 , respectively .


One month post-second dose of qHPV and HAV/HBV vaccine , in both study groups 99.5-100 % of subjects had an anti-HAV titer 20IU/L , 97.5-97 .6 % an anti-HBs level 10IU/L , and 100 % had an anti-HPV titer 3LU .


Thirty-six months post-second dose of qHPV all but four subjects ( 99 % ) had antibodies to HPV18 and 100 % had antibodies to HPV6 , 11 and 16 .


The great majority ( 97-100 % ) had an anti-HPV titer 3 LU .


Post-second dose administration of qHPV and HAV/HBV , no meaningful difference was observed in the immune response in the two study groups to any component of vaccines .


The results indicate that qHPV and HAV/HBV can be given during the same vaccination session .


Two doses of of qHPV and HAV/HBV vaccines induce a strong immune response .


Three years post-second dose of qHPV , the great majority of subjects had antibodies to HPV types included in the vaccine .


A two-dose schedule for pre-adolescents might be a reasonable alternative to the currently approved three-dose schedules .


To compare outcomes between increasing versus maintaining the dose of mirtazapine in patients with depression without initial improvement .


Data from a 6-week double-blind randomized placebo-controlled trial of mirtazapine in major depressive disorder ( DSM-IV ) conducted from November 2004 to December 2005 were used .


Percentages of remitters ( ie , a score of 7 in the 17-item Hamilton Depression Rating Scale [ HDRS-17 ] ) and HDRS-17 score changes from baseline to week 6 were compared in the following 2 pairs , using Fisher exact test or mixed-effects model for repeated measures : ( 1 ) subjects who failed to show a 20 % decrease in the HDRS-17 total scores at week 1 but were assigned to continue 15 mg/d ( stay ( 15 ) group ) versus those who were assigned to increase the dose to 30 mg/d ( increase ( 30 ) group ) and ( 2 ) subjects who failed to show a 20 % decrease in the HDRS-17 total scores with 30 mg/d at week 2 but were assigned to continue 30 mg/d ( stay ( 30 ) group ) versus those who were assigned to increase the dose to 45 mg/d ( increase ( 45 ) group ) .


The increase ( 30 ) group showed a numerically but not significantly higher remission rate and a significantly greater decrease in the HDRS-17 total score at week 6 than the stay ( 15 ) group ( 34.7 % [ 8 of 23 patients ] vs 14.3 % [ 3 of 21 patients ] , P = .2 ; least squares mean , -15.8 vs -10.9 , P = .003 ) .


No significant differences were found between the increase ( 45 ) and stay ( 30 ) groups .


Dose increase of mirtazapine from 15 mg/d to 30 mg/d may be effective for patients with depression without initial improvement .


However , effectiveness may not be the case beyond 30 mg/d .


JapicCTI identifier : 152830 .


The effects that artemether-lumefantrine ( AL ) has on gametocyte dynamics in the short-term have recently been described .


However there is limited long-term longitudinal data on the effect of AL on gametocyte dynamics in asymptomatic children .


An epidemiological study was conducted in Kombewa , Western Kenya , in which 270 asymptomatic children aged between 12 and 47 months were enrolled .


The subjects were randomized to receive either a course of AL or placebo at enrolment .


Active follow-up was conducted for one year .


The gametocyte prevalence and density dynamics throughout the study period mirrored that of the asexual forms .


The proportion of initially parasitaemic subjects becoming gametocytaemic was significantly lower in the AL arm for the first 12 weeks following randomization .


The geometric mean gametocyte density was lower in the AL arm for 2 weeks following randomization .


None of the variables of interest had a statistically significant effect on the duration of gametocytaemia .


There is no effect seen in subjects who are not parasitaemic at the time of drug administration .


The treatment of asymptomatic parasitaemic subjects with AL results in a significant reduction in the proportion of subjects who become gametocytaemic for at least 12 weeks .


The National Athletic Trainers ' Association position statement on acute management of the cervical spine-injured athlete recommended the all-or-nothing endeavor , which involves removing or not removing both helmet and shoulder pads , from equipment-laden American football and ice hockey athletes .


However , in supporting research , investigators have not considered alternative protocols .


To measure cervical spine movement ( head relative to sternum ) produced when certified athletic trainers ( ATs ) use the all-or-nothing endeavor and to compare these findings with the movement produced using an alternative pack-and-fill protocol , which involves packing the area under and around the cervical neck and head with rolled towels .


Crossover study .


Movement analysis laboratory .