Completeness of resection was significantly higher in PDT arm ( R0-89 % , R1-11 % ) vs. No-PDT arm ( R0-54 % , R1-46 % ) , p = 0.038 .


The study demonstrated that neoadjuvant PDT along with chemotherapy is effective , safe and it makes possible to convert to surgery candidates and to improve resection completeness in stage III central NSCLC patients .


To determine the safety and efficacy of low-voltage , external-beam , stereotactic radiotherapy ( SRT ) for patients with neovascular age-related macular degeneration ( AMD ) .


Randomized , double-masked , sham-controlled , multicenter , clinical trial .


A total of 230 participants with neovascular AMD who received 3 ranibizumab or bevacizumab injections within the preceding year and requiring treatment at enrollment .


Participants received 16 Gray , 24 Gray , or sham SRT .


All arms received pro re nata ( PRN ) ranibizumab for 12 months , with PRN bevacizumab or ranibizumab thereafter .


Mean number of PRN injections ; best-corrected visual acuity ( BCVA ) ; loss of < 15 Early Treatment of Diabetic Retinopathy Study letters ; change in optical coherence tomography central subfield thickness ; and change in angiographic total lesion area and choroidal neovascularization ( CNV ) area .


At year 2 , the 16 and 24 Gray arms received fewer PRN treatments compared with sham ( mean 4.5 , P = 0.008 ; mean 5.4 , P = 0.09 ; and mean 6.6 , respectively ) .


Change in mean BCVA was -10.0 , -7.5 , and -6.7 letters for the 16 Gray , 24 Gray , and sham arms , respectively , with 46 ( 68 % ) , 51 ( 75 % ) , and 58 participants ( 79 % ) , respectively , losing < 15 letters .


Mean central subfield thickness decreased by 67.0 m , 55.4 m , and 33.3 m , respectively .


Mean total active lesion area increased by 1.0 , 4.2 , and 2.7 mm ( 2 ) , respectively .


Mean CNV area decreased by 0.1 mm ( 2 ) in all groups .


An independent reading center detected microvascular abnormalities in 6 control eyes and 29 SRT eyes , of which 18 were attributed to radiation ; however , only 2 of these possibly affected vision .


An exploratory subgroup analysis found that lesions with a greatest linear dimension 4 mm ( the size of the treatment zone ) and a macular volume greater than the median ( 7.4 mm ( 3 ) ) were more responsive to SRT , with 3.9 PRN injections versus 7.1 in comparable sham-treated participants ( P = 0.001 ) and mean BCVA 4.4 letters superior to sham ( P = 0.24 ) .


A single dose of SRT significantly reduces intravitreal injections over 2 years .


Radiation can induce microvascular change , but in only 1 % of eyes does this possibly affect vision .


The best response occurs when AMD lesions fit within the treatment zone and they are actively leaking .


UK National Institute of Health and Clinical Excellence guidelines for obsessive compulsive disorder ( OCD ) specify recommendations for the treatment and management of OCD using a stepped care approach .


Steps three to six of this model recommend treatment options for people with OCD that range from low-intensity guided self-help ( GSH ) to more intensive psychological and pharmacological interventions .


Cognitive behavioural therapy ( CBT ) , including exposure and response prevention , is the recommended psychological treatment .


However , whilst there is some preliminary evidence that self-managed therapy packages for OCD can be effective , a more robust evidence base of their clinical and cost effectiveness and acceptability is required .


Our proposed study will test two different self-help treatments for OCD : 1 ) computerised CBT ( cCBT ) using OCFighter , an internet-delivered OCD treatment package ; and 2 ) GSH using a book .


Both treatments will be accompanied by email or telephone support from a mental health professional .


We will evaluate the effectiveness , cost and patient and health professional acceptability of the treatments .


This study will provide more robust evidence of efficacy , cost effectiveness and acceptability of self-help treatments for OCD .


If cCBT and/or GSH prove effective , it will provide additional , more accessible treatment options for people with OCD .


Current Controlled Trials : ISRCTN73535163 .


Date of registration : 5 April 2011 .


The PRODIGY trial ( Prevention of long term social disability amongst young people with emerging psychological difficulties , ISRCTN47998710 ) is a pilot trial of social recovery cognitive-behavioural therapy ( SRCBT ) .


The PRODIGY qualitative substudy aimed to ( a ) explore individual experiences of participating in the pilot randomised , controlled trial ( recruitment , randomisation , assessment ) and initial views of therapy , and ( b ) to explore perceived benefits of taking part in research v. ethical concerns and potential risks .


Qualitative investigation using semi-structured interviews with thematic analysis .


Analysis revealed participant experiences around the key themes of acceptability , disclosure , practicalities , altruism and engagement .


Participants in both trial arms perceived themselves as gaining benefits from being involved in the study , above and beyond the intervention .


This has implications for the design of future research and services for this client group , highlighting the importance of being flexible and an individualised approach as key engagement tools .


The purpose of this study was to test causal effects of physicians ' nonverbal involvement on medical error disclosure outcomes .


216 hospital outpatients were randomly assigned to two experimental treatment groups .


The first group watched a video vignette of a verbally effective and nonverbally involved error disclosure .


The second group was exposed to a verbally effective but nonverbally uninvolved error disclosure .


All patients responded to seven outcome measures .


Patients in the nonverbally uninvolved error disclosure treatment group perceived the physician 's apology as less sincere and remorseful compared to patients in the involved disclosure group .


They also rated the implications of the error as more severe , were more likely to ascribe fault to the physician , and indicated a higher intent to change doctors after the disclosure .


The results of this study imply that nonverbal involvement during medical error disclosures facilitates more accurate patient understanding and assessment of the medical error and its consequences on their health and quality of life .


In the context of disclosing medical errors , nonverbal involvement increases the likelihood that physicians will be able to continue caring for their patient .


Thus , providers are advised to consider adopting this communication skill into their medical practice .


To study changes in the nuclear factor-B p65 ( NF-B p65 ) - inducible nitric oxide synthase ( iNOS ) - nitric oxide ( NO ) signaling pathway and the effects of Xinfeng capsules ( XFC ) in patients with ankylosing spondylitis ( AS ) .


One hundred twenty patients with AS were randomly divided into an XFC group and a Salazopyrin group .


Sixty health subjects were included as a normal control group .


In the two treatment groups , pulmonary functional parameters , forced vital capacity ( FVC ) , forced expiratory volume in 1 second ( FEV1 ) , maximal voluntary ventilation ( MVV ) , peak expiratory flow ( PEF ) , forced expiratory flow at 25 % of forced vital capacity ( FEF25 ) , forced expiratory flow at 50 % of forced vital capacity ( FEF50 ) , and forced expiratory flow at 75 % of forced vital capacity ( FEF75 ) were determined .


Enzyme linked immunosorbent assays were used for detection of the serum oxidative stress indexes , NF-B p65 , iNOS , NO , reactive oxygen species ( ROS ) , reactive nitrogen species ( RNS ) , malondialdehyde ( MDA ) , superoxide dismutase ( SOD ) , catalase ( CAT ) , total antioxidative capacity ( TAOC ) and interleukin-4 ( IL-4 ) , IL-10 , IL-1 , and tumor necrosis factor - ( TNF - ) contents .


Westergren 's method was used for determination of erythrocyte sedimentation rate ( ESR ) .


High-sensitivity C-reactive protein ( Hs-CRP ) was detected with a 7060 full-automatic biochemical analyzer ( Hitachi , Japan ) .


The clinical therapeutic effect in the XFC group was significantly superior to that in the Salazopyrin group ( P < 0.01 ) .


Compared with the normal control group , FEV1 , MVV , PEF , FEF50 , FEF75 , SOD , CAT , TAOC , IL-4 , IL-10 were significantly lower , and NF-B p65 , iNOS , NO , ROS , RNS , MDA , IL-1 , TNF - , ESR , and Hs-CRP significantly higher in patients with AS ( P < 0.01 or P < 0.05 ) .


Compared with before treatment , FEV1 , MVV , PEF , FEF50 , FEF75 , SOD , CAT , TAOC , IL-4 , and IL-10 were significantly increased , and NF-B p65 , iNOS , NO , ROS , RNS , MDA , IL-1 , TNF - , ESR , CRP , visual analog scales ( VAS ) , Bath ankylosing spondylitis disease active index , Bath ankylosing spondylitis functional index , and Bath ankylosing spondylitis global index significantly decreased in the two treatment groups after treatment ( P < .


0.01 or P < 0.05 ) , with significant differences between the XFC and Salazopyrin groups ( P < 0.01 or P < 0.05 ) .


Spearman correlation analysis indicated that FEV1 , MWVV , PEF , FEF50 , and FEF75 were positively correlated with SOD , CAT , TAOC , IL-4 , and IL-10 , and were negatively correlated with NF-B p65 , iNOS , NO , ROS , RNS , MDA , IL-13 , TNF - , ESR , and CRP .


Patients with AS have local pathologic changes in the spinal cord and other joints .


They also have decreased pulmonary function , which is negatively correlated with the NF-B-iNOS-NO signaling pathway , oxidative indexes , and inflammatory factors .


XFC improves rigidity and pain in spinal joints and other symptoms , laboratory indexes , and pulmonary function .


The mechanism is possibly related to inhibition of the NF-KB-iNOS-NO signaling pathway .


To describe the health-related quality of life ( HRQOL ) burden of cervical dystonia ( CD ) and report on the HRQOL and patient perception of treatment benefits of abobotulinumtoxinA ( Dysport ) .


The safety and efficacy of a single injection of abobotulinumtoxinA for CD treatment were evaluated in a previously reported international , multicenter , double-blind , randomised trial .


HRQOL measures were assessed in the trial and have not been previously reported .


Movement disorder clinics in the USA and Russia .


Patients had to have a diagnosis of CD with symptoms for at least 18months , as well as a total Toronto Western Spasmodic Torticollis Rating Scale ( TWSTRS ) score of at least 30 ; a Severity domain score of at least 15 ; and a Disability domain score of at least 3 .


Key exclusion criteria included treatment with botulinum toxin type A ( BoNT-A ) or botulinum toxin type B ( BoNT-B ) within 16weeks of enrolment .


Patients were randomised to receive either 500 U abobotulinumtoxinA ( n = 55 ) or placebo ( n = 61 ) .


Efficacy assessments included TWSTRS total ( primary end point ) and subscale scores at weeks 0 , 4 , 8 , 12 ; a pain visual analogue scale at weeks 0 and 4 ; and HRQOL assessed by the SF-36 Health Survey ( SF-36 ; secondary end point ) at weeks 0 and 8 .


Patients with CD reported significantly greater impairment for all SF-36 domains relative to US norms .


Patients treated with abobotulinumtoxinA reported significantly greater improvements in Physical Functioning , Role Physical , Bodily Pain , General Health and Role Emotional domains than placebo patients ( p0 .03 for all ) .


The TWSTRS was significantly correlated with Physical Functioning , Role Physical and Bodily Pain scores , for those on active treatment .


CD has a marked impact on HRQOL .


Treatment with a single abobotulinumtoxinA injection results in significant improvement in patients ' HRQOL .


The trial is registered at ClinicalTrials.gov , numbers NCT00257660 and NCT00288509 .


The prognostic utility of circulating plasma microRNA in patients with acute coronary syndromes ( ACS ) has been proposed but not yet demonstrated .


We set out to investigate circulating microRNA levels in patients incurring recent ACS and examined associations with neurohormones , cardiac structure and function , and survival over 5 years of follow-up .


An initial screen of 375 microRNAs was performed in 35 ACS patients and 16 healthy controls .


Candidates identified from the initial screen ( miR-323-3p , miR-652 , miR-27b , miR-103 and miR-208a ) were validated in a further cohort of 200 patients at baseline ( ~ 30 days post-ACS ) and at 4 and 12 months post-ACS , and compared with 100 controls .


In the validation cohort , significantly higher levels in patients were replicated for miR-323-3p , miR-652 and miR-27b ( 10-fold , 2.3-fold and 2.3-fold , respectively , adjusted p < 0.05 ) .


Lower levels of miR-103 were not replicated and miR-208a was undetectable .


From baseline to 4 months post-admission , miR-323-3p and miR-652 remained elevated in patients compared to controls ( adjusted p < 0.01 ) , with no further change in levels between 4 and 12 months ; whereas miR-27b fell to control levels by 4 months .


Baseline levels of miR-652 in the lowest tertile were significantly associated with readmission for heart failure ( log-rank p < 0.001 ) .


In combination with NT-proBNP and LVEF , miR-652 significantly improved risk stratification ( p < 0.001 ) .


Our study identifies miR-652 as a novel candidate biomarker for post-ACS prognosis beyond existing biomarkers of LVEF and NT-proBNP .


Moreover circulating miR-323-3p was markedly elevated in patients for at least a year post-ACS and may be a stable biomarker for ACS .


Prolonged ventilation and failed extubation are associated with increased harm and cost .


The added value of heart and respiratory rate variability ( HRV and RRV ) during spontaneous breathing trials ( SBTs ) to predict extubation failure remains unknown .


We enrolled 721 patients in a multicenter ( 12 sites ) , prospective , observational study , evaluating clinical estimates of risk of extubation failure , physiologic measures recorded during SBTs , HRV and RRV recorded before and during the last SBT prior to extubation , and extubation outcomes .


We excluded 287 patients because of protocol or technical violations , or poor data quality .


Measures of variability ( 97 HRV , 82 RRV ) were calculated from electrocardiogram and capnography waveforms followed by automated cleaning and variability analysis using Continuous Individualized Multiorgan Variability Analysis ( CIMVA ) software .


Repeated randomized subsampling with training , validation , and testing were used to derive and compare predictive models .


Of 434 patients with high-quality data , 51 ( 12 % ) failed extubation .


Two HRV and eight RRV measures showed statistically significant association with extubation failure ( P < 0.0041 , 5 % false discovery rate ) .


An ensemble average of five univariate logistic regression models using RRV during SBT , yielding a probability of extubation failure ( called WAVE score ) , demonstrated optimal predictive capacity .


With repeated random subsampling and testing , the model showed mean receiver operating characteristic area under the curve ( ROC AUC ) of 0.69 , higher than heart rate ( 0.51 ) , rapid shallow breathing index ( RBSI ; 0.61 ) and respiratory rate ( 0.63 ) .


After deriving a WAVE model based on all data , training-set performance demonstrated that the model increased its predictive power when applied to patients conventionally considered high risk : a WAVE score > 0.5 in patients with RSBI > 105 and perceived high risk of failure yielded a fold increase in risk of extubation failure of 3.0 ( 95 % confidence interval ( CI ) 1.2 to 5.2 ) and 3.5 ( 95 % CI 1.9 to 5.4 ) , respectively .


Altered HRV and RRV ( during the SBT prior to extubation ) are significantly associated with extubation failure .


A predictive model using RRV during the last SBT provided optimal accuracy of prediction in all patients , with improved accuracy when combined with clinical impression or RSBI .


This model requires a validation cohort to evaluate accuracy and generalizability .


ClinicalTrials.gov NCT01237886 .


Registered 13 October 2010 .


Electroencephalographic ( EEG ) status epilepticus is described in 10 to 35 % of patients with postanoxic encephalopathy after successful cardiopulmonary resuscitation and is associated with case fatality rates of 90 to 100 % .


It is unclear whether these EEG patterns represent a condition to be treated with anticonvulsants to improve outcome , or an expression of severe ischemic damage , in which treatment is futile .


TELSTAR is a multicenter clinical trial with two parallel groups , randomized treatment allocation , open label treatment , and blinded endpoint evaluation ( PROBE design ) .


We aim to enroll 172 adult patients with postanoxic encephalopathy and electroencephalographic status epilepticus after successful cardiopulmonary resuscitation , admitted to the ICU , in whom continuous EEG monitoring is started within 24 hours after admission .


Patients are randomly assigned to either medical treatment to suppress all electrographic seizure activity , or no treatment of electroencephalographic status epilepticus .


Antiepileptic treatment is based on guidelines for treatment of overt status epilepticus and is started within 3 hours after the diagnosis .


If status epilepticus returns during tapering of sedative medication after suppression of all epileptiform activity for 2 24 hours , it will be considered refractory .


The primary outcome measure is neurological outcome defined as the Cerebral Performance Category ( CPC ) score at 3 months , dichotomized into ` good ' ( CPC 1 to 2 = no or moderate neurological disability ) and ` poor ' ( CPC 3 to 5 = severe disability , coma , or death ) .


Secondary outcome measures include mortality and , for patients surviving up to 12 months , cognitive functioning , health related quality of life , and depression .


Clinicaltrials.gov ; NCT02056236 .


Date of registration : 4 February 2014 .


The influence of variations in exercise mode , thermal state , and load carriage on cardiac and ventilatory predictors of metabolic rate were investigated .


Fifteen males were studied at rest and during whole - , upper - , and lower-body exercise ( unloaded and loaded ) under thermoneutral and hot conditions .


Ventilatory predictions were superior in thermoneutral ( residual mean square error range : 0.04 to 0.17 Lmin ( -1 ) vs 0.21 to 0.36 Lmin ( -1 ) ) and hot conditions ( 0.03 to 0.07 Lmin ( -1 ) vs 0.21 to 0.24 Lmin ( -1 ) ) .


Predictions derived from whole - or lower-body exercise , and unloaded or loaded exercise could be interchanged without significant error .


Nevertheless , a mode-specific prediction was required for upper-body work , and mild hyperthermia significantly reduced the precision of cardiac predictions .


Ventilatory predictions were more precise , but errors from heart-rate predictions could be minimized by using thermal-state and exercise mode-specific predictions .


Long standing mitral valve disease is usually associated with severe pulmonary hypertension .


Perioperative pulmonary hypertension is a risk factor for right ventricular ( RV ) failure and a cause for morbidity and mortality in patients undergoing mitral valve replacement .


Phosphodiesterase 5 inhibitor-sildenafil citrate is widely used to treat primary pulmonary hypertension .


There is a lack of evidence of effects of oral sildenafil on secondary pulmonary hypertension due to mitral valve disease .


The study aims to assess the effectiveness of preoperative oral sildenafil on severe pulmonary hypertension and incidence of RV failure in patients undergoing mitral valve replacement surgery .


A total of 40 patients scheduled for mitral valve replacement with severe pulmonary hypertension ( RV systolic pressure ( RVSP ) 60 mmHg ) on preoperative transthoracic echo were randomly treated with oral sildenafil 25 mg ( N = 20 ) or placebo ( N = 20 ) eight hourly for 24 h before surgery .


Hemodynamic variables were measured 20 min after insertion of pulmonary artery catheter ( PAC ) under anesthesia ( T1 ) , 20 min at weaning from cardiopulmonary bypass ( CPB ) ( T2 ) and after 1,2 , and 6 h ( T3 , T4 , T5 , respectively ) during the postoperative period .


Systolic and mean pulmonary artery pressure ( MPAP ) and pulmonary vascular resistance index ( PVRI ) were significantly lower ( P < 0.0001 ) in sildenafil group at all times .


Ventilation time and postoperative recovery room stay were significantly lower ( P < 0.001 ) in sildenafil group .


Sildenafil produces significant pulmonary vasodilatory effect as compared with placebo in mitral valve replacement patients with severe pulmonary hypertension .


It also reduces ventilation time and intensive care unit ( ICU ) stay time as compared with placebo .


It is concluded that sildenafil is effective in reducing pulmonary hypertension when administered preoperatively in patients with severe pulmonary hypertension undergoing mitral valve replacement surgery .


Breech presentation occurs in up to 3 % of pregnancies at term and may be an indication for caesarean delivery .


External cephalic version can be effective in repositioning the fetus in a cephalic presentation , but may be painful for the mother .


Our aim was to assess the efficacy of remifentanil versus placebo for pain relief during external cephalic version .


A randomized , double-blind , controlled trial that included women at 36-41 weeks of gestation with non-cephalic presentations was performed .


Women were randomized to receive either a remifentanil infusion at 0.1 g/kg/min and demand boluses of 0.1 g/kg , or saline placebo .


The primary outcome was the numerical rating pain score ( 0-10 ) after external cephalic version .


Sixty women were recruited , 29 in the control group and 31 in the remifentanil group .


There were significant differences in pain scores at the end of the procedure ( control 6.5 2.4 vs. remifentanil 4.7 2.5 , P = 0.005 ) but not 10 min later ( P = 0.054 ) .


The overall success rate for external cephalic version was 49 % with no significant differences between groups ( remifentanil group 54.8 % vs. control group 41.3 % , P = 0.358 ) .


In the remifentanil group , there was one case of nausea and vomiting , one of drowsiness and three cases of fetal bradycardia .


In the control group , there were three cases of nausea and vomiting , one of dizziness and nine cases of fetal bradycardia .


Intravenous remifentanil with bolus doses on demand during external cephalic version achieved a reduction in pain and increased maternal satisfaction .


There were no additional adverse effects , and no difference in the success rate of external cephalic version or the incidence of fetal bradycardia .


People with stroke excessively move their trunk , when reaching and grasping objects .


To determine if the addition of trunk restraint to modified constraint-induced movement therapy ( mCIMT ) was better than mCIMT alone in improving strength , function , and quality of life after stroke .


A pilot randomized double-blinded clinical trial was conducted .


Twenty-two participants with chronic stroke were randomly assigned to an experimental group that received mCIMT plus trunk restraint , or a control group ( only mCIMT ) .


Primary outcomes were the amount of use and quality of movement of the paretic upper limb ( UL ) , determined by the Motor Activity Log ( MAL ) scores .


Secondary outcomes included the observed performance of the paretic UL during unimanual and bimanual tasks , kinematics of reaching , strength , and quality of life .


Both groups demonstrated significant improvements in the MAL scores and in the time to perform bimanual activities immediately after the interventions .


However , no between-group differences were observed .


The addition of trunk restraint to mCIMT resulted in no additional benefits , compared with mCIMT alone with stroke individuals with mild to moderate impairments .


Unimanual and bimanual improvements were observed after mCIMT , regardless of trunk restraint , and the intervention did not adversely affect their reaching patterns .


Theory-based interventions to promote physical activity ( PA ) are more effective than atheoretical approaches ; however , the comparative utility of theoretical models is rarely tested in longitudinal designs with multiple time points .


Further , there is limited research that has simultaneously tested social-cognitive models with self-report and objective PA measures .


The primary aim of this study was to test the predictive ability of three theoretical models ( social cognitive theory , theory of planned behaviour , and protection motivation theory ) in explaining PA behaviour .


Participants were adults with type 2 diabetes ( n = 287 , 53.8 % males , mean age = 61.6 11.8 years ) .


Theoretical constructs across the three theories were tested to prospectively predict PA behaviour ( objective and self-report ) across three 6-month time intervals ( baseline-6 , 6-12 , 12-18 months ) using structural equation modelling .


PA outcomes were steps/3 days ( objective ) and minutes of MET-weighted PA/week ( self-report ) .


The mean proportion of variance in PA explained by these models was 6.5 % for objective PA and 8.8 % for self-report PA. .


Direct pathways to PA outcomes were stronger for self-report compared with objective PA. .


These theories explained a small proportion of the variance in longitudinal PA studies .


Theory development to guide interventions for increasing and maintaining PA in adults with type 2 diabetes requires further research with objective measures .


Theory integration across social-cognitive models and the inclusion of ecological levels are recommended to further explain PA behaviour change in this population .


Statement of contribution What is already known on this subject ?


Social-cognitive theories are able to explain partial variance for physical activity ( PA ) behaviour .


What does this study add ?


The testing of three theories in a longitudinal design over 3 , 6-month time intervals .


The parallel use and comparison of both objective and self-report PA measures in testing these theories .


Monitoring implementation of the `` test and treat '' case-management policy for malaria is an important component of all malaria control programmes in Africa .


Unfortunately , routine information systems are commonly deficient to provide necessary information .


Using health facility surveys we monitored health systems readiness and malaria case-management practices prior to and following implementation of the 2010 `` test and treat '' policy in Kenya .


Between 2010 and 2013 six national , cross-sectional , health facility surveys were undertaken .


The number of facilities assessed ranged between 172 and 176 , health workers interviewed between 216 and 237 and outpatient consultations for febrile patients evaluated between 1,208 and 2,408 across six surveys .


Comparing baseline and the last survey results , all readiness indicators showed significant ( p < 0.005 ) improvements : availability of parasitological diagnosis ( 55.2 % to 90.7 % ) ; RDT availability ( 7.5 % to 69.8 % ) ; total artemether-lumefantrine ( AL ) stock-out ( 27.2 % to 7.0 % ) ; stock-out of one or more AL packs ( 59.5 % to 21.6 % ) ; training coverage ( 0 to 50.2 % ) ; guidelines access ( 0 to 58.1 % ) and supervision ( 17.9 % to 30.8 % ) .


Testing increased by 34.0 % ( 23.9 % to 57.9 % ; p < 0.001 ) while testing and treatment according to test result increased by 34.2 % ( 15.7 % to 49.9 % ; p < 0.001 ) .


Treatment adherence for test positive patients improved from 83.3 % to 90.3 % ( p = 0.138 ) and for test negative patients from 47.9 % to 83.4 % ( p < 0.001 ) .


Significant testing and treatment improvements were observed in children and adults .


There was no difference in practices with respect to the type and result of malaria test ( RDT vs microscopy ) .


Of eight dosing , dispensing and counseling tasks , improvements were observed for four tasks .


Overall AL use for febrile patients decreased from 63.5 % to 35.6 % ( p < 0.001 ) .


Major improvements in the implementation of `` test and treat '' policy were observed in Kenya .


Some gaps towards universal targets still remained .


Other countries facing similar needs and challenges may consider health facility surveys to monitor malaria case-management .


The aim of the study was to evaluate the effectiveness of intravenous iron versus placebo added to standard oral iron therapy in the treatment of severe postpartum anaemia .


A randomised , double-blind , parallel-group , placebo-controlled clinical trial was performed in a single centre .


Hospital Clinic of Barcelona , Barcelona , Spain .


A cohort of 72 women with severe postpartum anaemia ( 6.0-8 .0 g/dl ) treated with oral ferrous sulphate ( two tablets of 525mg ) .


Women were randomised to receive either intravenous ferrous sucrose ( 200mg/24hours for two consecutive days ) or intravenous placebo , in addition to standard iron therapy .


Clinical and laboratory data were obtained at 1 , 2 , and 6weeks .


Haemoglobin and haematocrit at 1 , 2 , and 6weeks .


Other haematological and clinical parameters , psychological status , and adverse side effects were also evaluated .


Haemoglobin and haematocrit values were comparable in women receiving intravenous iron or placebo in addition to oral iron therapy at any of the time points .


At 6weeks , haemoglobin level ( meanSD ) was 12.21.0 versus 12.20.9 g/dl , with a mean difference of -0.03 ( 95 % CI -0.6 to 0.6 ) , in the placebo and in the intravenous iron groups , respectively .


No differences were found between clinical symptoms of anaemia , psychological status , and adverse side effects between groups .


Intravenous iron added to oral iron therapy did not show significant benefits over placebo , neither in haemoglobin rise nor in symptoms or adverse side effects .


Evidence suggests a positive association between administration of psychoactive drugs and rates of cigarette smoking .


Prevalence of smoking among opioid-dependent individuals , for example , is four times greater than the general population .


We recently completed a randomized double-blind trial evaluating outpatient buprenorphine taper for prescription opioid ( PO ) abusers , which provided a unique opportunity to examine naturalistic changes in smoking among participants who detoxified without resumption of illicit opioid use .


Participants received no smoking-cessation services and were not encouraged to alter their smoking in any way .


A subset of 10 opioid-dependent smokers , who were randomized to receive the same 4-week buprenorphine taper and successfully completed detoxification , were included in the present study .


They provided staff-observed urine specimens thrice-weekly throughout the 12-week trial .


Specimens were analyzed on-site via enzyme-multiplied immunoassay for urinary cotinine , a metabolite of nicotine that provides a sensitive biochemical measure of smoking status .


Mean cotinine levels were significantly different across study phases , with significantly lower cotinine levels during taper ( 1317.5 ng/ml ) and post-taper ( 1015.8 ng/ml ) vs. intake ( 1648.5 ng/ml ) phases ( p '' s < .05 ) .


Overall , mean cotinine levels decreased by 38 % between intake and end-of-study , reflecting a reduction of approximately eight cigarettes per day .


These data provide additional evidence that opioids influence smoking and extend prior findings to include primary PO abusers , rigorous double-blind opioid dosing conditions and urinary cotinine .


These results also suggest that , while likely insufficient for complete cessation , patients who successfully taper from opioids may also experience concurrent reductions in smoking and thus may be ideal candidates for smoking cessation services .


We evaluated whether presenting prescription drug efficacy information in direct-to-consumer ( DTC ) advertising helps individuals accurately report a drug 's benefits and , if so , which numerical format is most helpful .


We conducted a randomized , controlled study of individuals diagnosed with high cholesterol ( n = 2807 ) who viewed fictitious prescription drug print or television ads containing either no drug efficacy information or efficacy information in one of five numerical formats .


We measured drug efficacy recall , drug perceptions and attitudes , behavioral intentions , and drug risk recall .


Individuals who viewed absolute frequency and/or percentage information more accurately reported drug efficacy than participants who viewed no efficacy information .


Participants who viewed relative frequency information generally reported drug efficacy less accurately than participants who viewed other numerical formats .


Adding efficacy information to DTC ads-both in print and on television-may potentially increase an individual 's knowledge of a drug 's efficacy , which may improve patient-provider communication and promote more informed decisions .


Providing quantitative efficacy information in a combination of formats ( e.g. , absolute frequency and percent ) may help patients remember information and make decisions about prescription drugs .


The aim of the present study was to investigate the analgesic and anti-inflammatory effects of dexketoprofen trometamol ( DT ) and paracetamol on deep acute somatic pain and inflammation in patients undergoing impacted third molar surgery .


This study was planned to present benefits that we could obtain with low burden of drug .


Effects of drugs , which were administered preemptively before the procedure , on pain , mouth-opening limitation , and swelling were assessed by visual analogue scale ( VAS ) , magnetic resonance imaging ( MRI ) , and mouth-opening measurement .


Following surgery , time intervals when the patients first need to receive the drug were measured .


The VAS scores of the patients were lower in the side treated with DT than that in the paracetamol treated side .


There was no significant difference between the groups in terms of mouth-opening limitation .


MRI recordings revealed that swelling was lower in the side treated with paracetamol than DT treated side .


Administration of the drugs before surgery contributed to the postoperative patient comfort .


The analgesic activity of 12.5 mg dose of DT was similar to , even better than , the analgesic activity of 500 mg dose of paracetamol ; however , DT had insufficient anti-inflammatory efficacy .


This study aims to compare the effects of a lifestyle intervention using a behavioral therapy ( BT ) approach with the effects of a cardioprotective structured hypocaloric diet on metabolic syndrome in Mexican postmenopausal women .


This study is a randomized clinical trial ( 2006-2009 ) of Mexican postmenopausal women with metabolic syndrome ( Adult Treatment Panel III criteria ) who were recruited from the Postmenopause Clinic of the National Institute of Perinatology in Mexico City .


Women were assigned to one of two groups -- group 1 ( structured hypocaloric diet ; n = 63 ) : energy restriction ( -300 to -500 kcal/d ) emphasizing cardioprotective dietary changes ; and group 2 ( BT ; n = 55 ) : goal setting , problem-solving , and stimulus control to achieve cardioprotective dietary and lifestyle recommendations .


Metabolic syndrome prevalence , as well as weight , waist circumference , fat mass , and fasting biochemical markers ( glucose and lipid profile ) , were measured at baseline and at 2 , 4 , and 6 months after the intervention .


Metabolic syndrome risk ( relative risk and absolute risk reduction ) , mean differences between groups , and logistic regression were evaluated using Statistical Package for the Social Sciences software , version 17.0 .


A total of 118 women were studied ( mean [ SD ] age , 53.81 [ 6.43 ] y ) .


No baseline differences were observed between groups .


At the end of the study , a higher reduction in metabolic syndrome prevalence was observed in group 1 ( -38.1 % ) compared with group 2 ( -12.7 % ; relative risk , 0.237 ; 95 % CI , 0.092-0 .608 ; P = 0.003 ) .


The effect was maintained even when adjusted by age , hormone therapy and antihypertensive drug use .


A cardioprotective structured hypocaloric diet is more effective than the BT approach in reducing metabolic syndrome after 6 months of intervention .


Both strategies have positive effects on different individual cardiovascular risk factors .


Randomized controlled trials ( RCTs ) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies .


However , researchers conducting RCTs commonly report difficulties in recruiting an adequate sample within planned timescales .


In an effort to overcome recruitment difficulties , researchers often are forced to expand their recruitment criteria or extend the recruitment phase , thus increasing costs and delaying publication of results .


Research investigating the effectiveness of recruitment strategies is limited , and trials often fail to report sufficient details about the recruitment sources and resources utilized .


We examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression .


We describe eight recruitment methods utilized and two further sources not initiated by the research team and examine their efficacy in terms of ( 1 ) the return , including the number of potential participants who contacted the trial and the number who were randomized into the trial ; ( 2 ) cost-effectiveness , comprising direct financial cost and manpower for initial contacts and randomized participants ; and ( 3 ) comparison of sociodemographic characteristics of individuals recruited from different sources .


Poster advertising , web-based advertising , and mental health worker referrals were the cheapest methods per randomized participant ; however , the ratio of randomized participants to initial contacts differed markedly per source .


Advertising online , via posters , and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial .


Advertising across many sources ( saturation ) was found to be important .


It may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other populations , such as those currently unwell , or in other geographical locations .


Recruitment source was unavailable for participants who could not be reached after the initial contact .


Thus , it is possible that the efficiency of certain methods of recruitment was poorer than estimated .


Efficacy and costs of other recruitment initiatives , such as providing travel expenses to the in-person eligibility assessment and making follow-up telephone calls to candidates who contacted the recruitment team but could not be screened promptly , were not analysed .


Website advertising resulted in the highest number of randomized participants and was the second cheapest method of recruiting .


Future research should evaluate the effectiveness of recruitment strategies for other samples to contribute to a comprehensive base of knowledge for future RCTs .


Interventions promoting physical activity by General Practitioners ( GPs ) lack a strong evidence base .


Recruiting participants to trials in primary care is challenging .


We investigated the feasibility of ( i ) delivering three interventions to promote physical activity in inactive participants and ( ii ) different methods of participant recruitment and randomised allocation .


We recruited general practices from Devon , Bristol and Coventry .


We used a 2-by-2 factorial design for participant recruitment and randomisation .


Recruitment strategies were either opportunistic ( approaching patients attending their GP surgery ) or systematic ( selecting patients from practice lists and approaching them by letter ) .


Randomisation strategies were either individual or by practice cluster .


Feasibility outcomes included time taken to recruit the target number of participants within each practice .


Participants were randomly allocated to one of three interventions : ( i ) written advice ( control ) ; ( ii ) brief GP advice ( written advice plus GP advice on physical activity ) , and ( iii ) brief GP advice plus a pedometer to self-monitor physical activity during the trial .


Participants allocated to written advice or brief advice each received a sealed pedometer to record their physical activity , and were instructed not to unseal the pedometer before the scheduled day of data collection .


Participant level outcomes were reported descriptively and included the mean number of pedometer steps over a 7-day period , and European Quality of Life ( EuroQoL ) -5 dimensions ( EQ-5D ) scores , recorded at 12weeks ' follow-up .


We recruited 24 practices ( 12 using each recruitment method ; 18 randomising by cluster , 6 randomising by individual participant ) , encompassing 131 participants .


Opportunistic recruitment was associated with less time to target recruitment compared with systematic ( mean difference ( days ) -54.9 , 95 % confidence interval ( CI ) -103.6 ; -6.2 ) but with greater loss to follow up ( 28.8 % versus .


6.9 % ; mean difference 21.9 % ( 95 % CI 9.6 % ; 34.1 % ) ) .


There were differences in the socio-demographic characteristics of participants according to recruitment method .


There was no clear pattern of change in participant level outcomes from baseline to 12weeks across the three arms .


Delivering and trialling GP-led interventions to promote physical activity is feasible , but trial design influences time to participant recruitment , participant withdrawal , and possibly , the socio-demographic characteristics of participants .


ISRCTN73725618 .


In this study we tested the hypothesis that tirasemtiv , a selective fast skeletal muscle troponin activator that sensitizes the sarcomere to calcium , could amplify the response of muscle to neuromuscular input in humans .


Healthy men received tirasemtiv and placebo in a randomized , double-blind , 4-period , crossover design .


The deep fibular nerve was stimulated transcutaneously to activate the tibialis anterior muscle and produce dorsiflexion of the foot .


The force-frequency relationship of tibialis anterior dorsiflexion was assessed after dosing .


Tirasemtiv increased force produced by the tibialis anterior in a dose - , concentration - , and frequency-dependent manner with the largest increases [ up to 24.5 % ( SE 3.1 ) , P < 0.0001 ] produced at subtetanic nerve stimulation frequencies ( 10 Hz ) .


The data confirm that tirasemtiv amplifies the response of skeletal muscle to nerve input in humans .


This outcome provides support for further studies of tirasemtiv as a potential therapy in conditions marked by diminished neuromuscular input .


The present study addressed the ecological validity of the individual-focused experimental paradigm in sex research .


The aim of this study was to investigate the effect of partner presence vs. absence in the laboratory testing situation , and of manipulation of attentional focus , on genital and subjective sexual arousal of healthy women and men .


Sexually functional heterosexual men ( n = 12 ) and women ( n = 12 ) and their partners participated in this study .


During partner presence , the partner sat opposite to the participant ; self-focused attention was experimentally manipulated by introducing , respectively , a semi-reflecting glass pane , and a wall-mounted camera .


Perceived state self-focused attention and genital and subjective sexual arousal during presentation of audiovisual erotic film stimuli were assessed .


Partner presence resulted in higher perceived self-focus ( ( p ) ( 2 ) = 0.22 ) and lower genital responses to erotic stimulation ( ( p ) ( 2 ) = 0.21 ) .


The interaction of partner presence and increased self-focused attention differentially affected genital arousal in female and male participants ( ( p ) ( 2 ) = 0.38 ) .


The mean genital response in men was lower during private self-focus than during non-self-focus with the partner present but was higher during private self-focus with the the partner absent ( ( p ) ( 2 ) = 0.23 ) .


The genital response in women to public self-focus was lower than to private self-focus and to non-self-focus with their partner present ( ( p ) ( 2 ) = 0.36 ) .


With the partner absent , the genital response in women to private self-focus was lower than to non-self-focus ( ( p ) ( 2 ) = 0.23 ) .


Retrospective subjective arousal of women was higher with partner present ( M = 3.2 ) than with partner absent ( M = 2.9 ) , whereas men reported higher retrospective subjective arousal with their partner absent ( M = 3.5 ) than present ( M = 3.1 ) .


These findings suggest that mere presence of the partner impacts the sexual response differentially in women and men .


Enhancing the ecological validity of the individual-based laboratory paradigm for sex research warrants closer examination in future research .


About one third of patients prescribed blood pressure or lipid-lowering drugs for the prevention of coronary heart disease and stroke do not take their medication as prescribed .


We conducted a randomized trial to evaluate text messaging as a means of improving adherence to cardiovascular disease preventive treatment .


303 patients taking blood pressure and/or lipid-lowering medications were randomly assigned to being sent text messages ( Text group , 151 ) or not being sent them ( No text group , 152 ) .


Texts were sent daily for 2 weeks , alternate days for 2 weeks and weekly thereafter for 22 weeks ( 6 months overall ) , using an automated computer programme .


Patients were asked to respond on whether they had taken their medication , whether the text reminded them to do so if they had forgotten , and if they had not taken their medication to determine if there was a reason for not doing so .


At 6 months , use of medication was assessed .


Two patients were lost to follow-up , providing data on 301 for analysis .


In the No text group 38/151 ( 25 % ) took less than 80 % of the prescribed regimen ( ie .


stopped medication completely or took it on fewer than 22 of the last 28 days of follow-up ) compared to 14/150 patients ( 9 % ) in the Text group - an improvement in adherence affecting 16 per 100 patients ( 95 % CI 7 to 24 ) , p < 0.001 .


The texts reminded 98/151 patients ( 65 % ) to take medication on at least one occasion and lead to 20/151 ( 13 % ) who stopped taking medication because of concern over efficacy or side-effects , resuming treatment .


In patients taking blood pressure or lipid-lowering treatment for the prevention of cardiovascular disease , text messaging improved medication adherence compared with no text messaging .


Controlled-Trials .


com ISRCTN74757601 .


A novel , fully bacterially produced recombinant virus-like particle ( VLP ) based influenza vaccine ( gH1-Qbeta ) against A/California/07 / 2009 ( H1N1 ) was tested in a double-blind , randomized phase I clinical trial at two clinical sites in Singapore .


The trial evaluated the immunogenicity and safety of gH1-Qbeta in the presence or absence of alhydrogel adjuvant .


Healthy adult volunteers with no or low pre-existing immunity against A/California/07 / 2009 ( H1N1 ) were randomized to receive two intramuscular injections 21 days apart , with 100g vaccine , containing 42g hemagglutinin antigen .


Antibody responses were measured before and 21 days after each immunization by hemagglutination inhibition ( HAI ) assays .


The primary endpoint was seroconversion on Day 42 , defined as percentage of subjects which reach a HAI titer 40 or achieve an at least 4-fold rise in HAI titer ( with pre-existing immunity ) .


The co-secondary endpoints were safety and seroconversion on Day 21 .


A total of 84 Asian volunteers were enrolled in this study and randomized to receive the adjuvanted ( n = 43 ) or the non-adjuvanted ( n = 41 ) vaccine .


Of those , 43 and 37 respectively ( 95 % ) completed the study .


There were no deaths or serious adverse events reported during this trial .


A total of 535 adverse events occurred during treatment with 49.5 % local solicited symptoms , of mostly ( 76.4 % ) mild severity .


The most common treatment-related systemic symptom was fatigue .


The non-adjuvanted vaccine met all primary and secondary endpoints and showed seroconversion in 62.2 % and 70.3 % of participants respectively on Day 21 and Day 42 .


While the adjuvanted vaccine showed an increased seroconversion from 25.5 % ( Day 21 ) to 51.2 % ( Day 42 ) , it did not meet the immunogenicity endpoint .


In summary , non-adjuvanted gH1-Qbeta showed similar antibody mediated immunogenicity and a comparable safety profile in healthy humans to commercially available vaccines .


These results warrant the consideration of this VLP vaccine platform for the vaccination against influenza infection ( HSA CTC1300092 ) .


Two percent chlorhexidine gluconate ( CHG ) is used in preparing the skin of surgical patients .


In practice , it often is diluted with saline prior to use .


Whether this affects efficacy is unknown , as the manufacturer does not address dilution but does recommend scrubbing twice .


We attempted to determine whether diluting CHG affects its antiseptic potency and if one scrub is as effective as two .


To test effects of CHG dilution , 60 healthy subjects were recruited and randomized into a dilution group ( 20 % , 40 % , 60 % , 80 % , or 100 % CHG ) or a control group ( saline ) .


One area of one foot of each subject was prepared , and colony-forming units ( CFU ) were counted at baseline and at 10min after preparation .


In a second study , 60 subjects were again recruited .


Based on the previous study , a 50 % dilution was applied as the scrub .


Colony-forming units were calculated at baseline and after each CHG application .


Baseline CFU did not differ among the dilution groups ( p = 0.49 ) .


Subjects in all dilution groups exhibited nearly a 100 % decrease in CFU , whereas the control group exhibited an 80 % decrease .


These results were statistically significant ( p < 0.01 ) .


In the second study , the CFU values after two scrubs ( mean 0.1 ; range 0-3 ) were significantly lower than after one scrub ( mean 3.6 , range 0-100 ) ( p = 0.02 ) .


Diluting CHG to a concentration as low as 0.4 % does not affect antiseptic efficacy .


The manufacturer-recommended two scrubs is superior to one scrub at reducing skin bacterial colony counts .


Although uncomplicated cystitis is often self-limiting , most such patients will be prescribed antibiotic treatment .


We are investigating whether treatment of cystitis with an NSAID is as effective as an antibiotic in achieving symptomatic resolution .


This is a randomized , controlled , double blind trial following the principles of Good Clinical Practice .


Women between the ages of 18 to 60 presenting with symptoms of uncomplicated cystitis are screened for eligibility .


500 women from four sites in Norway , Sweden and Denmark are allocated to treatment with 600 mg ibuprofen three times a day or 200 mg mecillinam three times a day for three days .


Allocation is conducted using block randomization .


The primary outcome is the number of patients who feel cured by day four as recorded in a diary .


Adverse events will be handled and reported in accordance with Good Clinical Practice .


If treatment of uncomplicated cystitis with ibuprofen is as effective as mecillinam for symptom relief , we can potentially reduce the use of antibiotics on a global scale .


EudraCTnr : 2012-002776-14 .


ClinicalTrials.gov : NCT01849926 .


Intravenous loop diuretics are a cornerstone of therapy in acutely decompensated heart failure ( ADHF ) .


We sought to determine if there are any differences in clinical outcomes between intravenous bolus and continuous infusion of loop diuretics .


Subjects with ADHF within 12 hours of hospital admission were randomly assigned to continuous infusion or twice daily bolus therapy with furosemide .


There were three co-primary endpoints assessed from admission to discharge : the mean paired changes in serum creatinine , estimated glomerular filtration rate ( eGFR ) , and reduction in B-type natriuretic peptide ( BNP ) .


Secondary endpoints included the rate of acute kidney injury ( AKI ) , change in body weight and six months follow-up evaluation after discharge .


A total of 43 received a continuous infusion and 39 were assigned to bolus treatment .


At discharge , the mean change in serum creatinine was higher ( +0.8 0.4 versus -0.8 0.3 mg/dl P < 0.01 ) , and eGFR was lower ( -9 7 versus +5 6 ml/min/1 .73 m ( 2 ) P < 0.05 ) in the continuous arm .


There was no significant difference in the degree of weight loss ( -4.1 1.9 versus -3.5 2.4 kg P = 0.23 ) .


The continuous infusion arm had a greater reduction in BNP over the hospital course , ( -576 655 versus -181 527 pg/ml P = 0.02 ) .


The rates of AKI were comparable ( 22 % and 15 % P = 0.3 ) between the two groups .


There was more frequent use of hypertonic saline solutions for hyponatremia ( 33 % versus 18 % P < 0.01 ) , intravenous dopamine infusions ( 35 % versus 23 % P = 0.02 ) , and the hospital length of stay was longer in the continuous infusion group ( 14.3 5 versus 11.5 4 days , P < 0.03 ) .


At 6 months there were higher rates of re-admission or death in the continuous infusion group , 58 % versus 23 % , ( P = 0.001 ) and this mode of treatment independently associated with this outcome after adjusting for baseline and intermediate variables ( adjusted hazard ratio = 2.57 , 95 % confidence interval , 1.01 to 6.58 P = 0.04 ) .


In the setting of ADHF , continuous infusion of loop diuretics resulted in greater reductions in BNP from admission to discharge .


However , this appeared to occur at the consequence of worsened renal filtration function , use of additional treatment , and higher rates of rehospitalization or death at six months .


ClinicalTrials.gov NCT01441245 .


Registered 23 September 2011 .


Prolonged exposure ( PE ) therapy for post-traumatic stress disorder ( PTSD ) in military veterans has established efficacy , but is ineffective for a substantial number of patients .


PE is also associated with high dropout rates .


We hypothesized that hydrocortisone augmentation would enhance symptom improvement and reduce drop-out rates by diminishing the distressing effects of traumatic memories retrieved during imaginal exposure .


We also hypothesized that in responders , hydrocortisone augmentation would be more effective in reversing glucocorticoid indices associated with PTSD than placebo augmentation .


Twenty-four veterans were randomized to receive either 30 mg oral hydrocortisone or placebo prior to PE sessions 3-10 in a double-blind protocol .


Glucocorticoid receptor sensitivity was assessed in cultured peripheral blood mononuclear cells ( PBMC ) using the in vitro lysozyme inhibition test and was determined before and after treatment .


Intent-to-treat analysis was performed using latent growth curve modeling of treatment effects on change in PTSD severity over time .


Veterans who no longer met diagnostic criteria for PTSD at post-treatment were designated as responders .


Veterans randomized to hydrocortisone or placebo augmentation did not differ significantly in clinical severity or glucocorticoid sensitivity at pre-treatment .


Hydrocortisone augmentation was associated with greater reduction in total PTSD symptoms compared to placebo , a finding that was explained by significantly greater patient retention in the hydrocortisone augmentation condition .


A significant treatment condition by responder status interaction for glucocorticoid sensitivity indicated that responders to hydrocortisone augmentation had the highest pre-treatment glucocorticoid sensitivity ( lowest lysozyme IC50-DEX ) that diminished over the course of treatment .


There was a significant association between decline in glucocorticoid responsiveness and improvement in PTSD symptoms among hydrocortisone recipients .


The results of this pilot study suggest that hydrocortisone augmentation of PE may result in greater retention in treatment and thereby promote PTSD symptom improvement .


Further , the results suggest that particularly elevated glucocorticoid responsiveness at pre-treatment may identify veterans likely to respond to PE combined with an intervention that targets glucocorticoid sensitivity .


Confirmation of these findings will suggest that pharmacologic interventions that target PTSD-associated glucocorticoid dysregulation may be particularly helpful in promoting a positive clinical response to PTSD psychotherapy .


Hypertension develops early in patients with autosomal dominant polycystic kidney disease ( ADPKD ) and is associated with disease progression .


The renin-angiotensin-aldosterone system ( RAAS ) is implicated in the pathogenesis of hypertension in patients with ADPKD .


Dual blockade of the RAAS may circumvent compensatory mechanisms that limit the efficacy of monotherapy with an angiotensin-converting-enzyme ( ACE ) inhibitor or angiotensin II-receptor blocker ( ARB ) .


In this double-blind , placebo-controlled trial , we randomly assigned 486 patients , 18 to 64 years of age , with ADPKD ( estimated glomerular filtration rate [ GFR ] , 25 to 60 ml per minute per 1.73 m ( 2 ) of body-surface area ) to receive an ACE inhibitor ( lisinopril ) and placebo or lisinopril and an ARB ( telmisartan ) , with the doses adjusted to achieve a blood pressure of 110/70 to 130/80 mm Hg .


The composite primary outcome was the time to death , end-stage renal disease , or a 50 % reduction from the baseline estimated GFR .


Secondary outcomes included the rates of change in urinary aldosterone and albumin excretion , frequency of hospitalizations for any cause and for cardiovascular causes , incidence of pain , frequency of ADPKD-related symptoms , quality of life , and adverse study-medication effects .


Patients were followed for 5 to 8 years .


There was no significant difference between the study groups in the incidence of the composite primary outcome ( hazard ratio with lisinopril-telmisartan , 1.08 ; 95 % confidence interval , 0.82 to 1.42 ) .


The two treatments controlled blood pressure and lowered urinary aldosterone excretion similarly .


The rates of decline in the estimated GFR , urinary albumin excretion , and other secondary outcomes and adverse events , including hyperkalemia and acute kidney injury , were also similar in the two groups .


Monotherapy with an ACE inhibitor was associated with blood-pressure control in most patients with ADPKD and stage 3 chronic kidney disease .


The addition of an ARB did not alter the decline in the estimated GFR .


( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; HALT-PKD [ Study B ] ClinicalTrials.gov number , NCT01885559 . )


Surgical extraction of lower third molars is followed by mild or severe postoperative pain which peaks at maximal intensity in the first 12 hours and has a significant impact on a patient 's postoperative quality of life .


The use of long-acting local anaesthetics is a promising strategy to improve postoperative analgesia .


The aim of the present study was to investigate analgesic parameters and patient satisfaction after using 0.5 % levobupivacaine ( Lbup ) , 0.5 % bupivacaine ( Bup ) and 2 % lidocaine with epinephrine 1:80,000 ( Lid + Epi ) for an inferior alveolar nerve block following lower third molar surgery .


A total of 102 patients ( ASA I ) were divided into three groups , each of which received either 3 mL of Lbup , Bup or Lid + Epi .


The intensity of postoperative analgesia was measured using a verbal rating scale ( VRS ) .


The total amounts of rescue analgesics were recorded on the first and during seven postoperative days .


Patients satisfaction was noted using a modified verbal scales .


A significantly higher level of postoperative pain was recorded in Lid + Epi group compared to Bup and Lbup groups .


No significant differences were seen between Bup and Lbup , but a significant reduction in the need for rescue analgesics was seen postoperatively in both Lbup and Bup ( 50 % ) in comparison with Lid + Epi ( 80 % ) in the first 24 hours .


The same significant trend in rescue analgesic consumption was recorded for seven postoperative days .


Patients ' overall satisfaction was significantly lower for Lid + Epi ( 10 % ) than for Lbup ( 56 % ) and Bup ( 52 % ) .


The use of a new and long-acting local anaesthetic 0.5 % levobupivacaine is clinically relevant and effective for an inferior alveolar nerve block and postoperative pain control after third molar surgery .


In our study Lbup and Bup controled postoperative pain more efficiently after lower third molar surgery compared to Lid + Epi .


Awake fiberoptic intubation is the gold standard for management of predicted difficult intubation .


The purpose of this study was to test whether Glide Scope video laryngoscopy ( GVL ) will provide significant advantages over fiberoptic bronchoscopy ( FOB ) for awake intubation in morbidly obese patients with predicted difficult intubation .


We therefore tested the hypothesis that intubation using GVL is faster than intubation with FOB .


64 morbidly obese patients with predicted difficult intubation undergoing laparoscopic bariatric surgery were enrolled in this study .


Patients were randomly assigned to receive awake oral intubation by either GVL or FOB .


After airway topical anesthesia and sedation using target controlled remifentanil infusion to a Ramsay sedation scale of 3 , wee compared the two devices for time to intubate , successful intubation on first attempt , glottic view using Cormack and Lehane score system , response of the patient to scope , patients satisfaction and incidence of postoperative sore throat and hoarseness .


Intubation time was 84 + / - 37.9 seconds and 73.6 + / - 31.1 seconds for FOB and GVL respectively .


75 % of patients were successfully intubated on the first attempt with FOB compared to 80.6 % with GVL .


Grade I/II glottic view was reported with GVL in 96.7 % of patients compared to 100 % with FOB .


The highest target concentration of remifentanil to maintain patients sedated during intubation was 2.4 + / - 0.6 ng/ml and 2.2 + / - 0.8 ng/ml in FOB and GVL respectively .


No significant differences regarding maximum patient response to intubation , adverse effects or patient satisfaction were recorded between groups .


GVL can be used as a useful alternative to FOB in morbidly obese patients with predicted difficult intubation .


Bevacizumab , a recombinant humanized monoclonal antibody against vascular endothelial growth factor , was approved by the US Food and Drug Administration for the treatment of advanced non-small-cell lung cancer ( NSCLC ) in combination with carboplatin and paclitaxel .


ARIES ( Avastin Regimens : Investigation of Effectiveness and Safety ) , a prospective observational cohort study , evaluated outcomes in a large , community-based population of patients with first-line NSCLC .


From 2006 to 2009 , ARIES enrolled patients with locally advanced or metastatic NSCLC who were eligible for bevacizumab , excluding those with predominantly squamous histology .


Patients were required to provide informed consent and to have initiated bevacizumab with chemotherapy within 4 months before enrollment .


There were no protocol-defined treatments or assessments .


The dosing of bevacizumab and chemotherapy , and the choice of chemotherapy regimen , was at the discretion of the treating physician .


ARIES enrolled 1967 patients with first-line NSCLC .


At study closure , median follow-up was 12.5 months ( range , 0.2-65 .5 ) .


Median age was 65 years ( range , 31-93 ) , and 252 patients ( 12.8 % ) identified as never smokers .


Median progression-free survival was 6.6 months ( 95 % confidence interval , 6.3-6 .9 ) , and median overall survival was 13.0 months ( 95 % confidence interval , 12.2-13 .8 ) with first-line bevacizumab plus chemotherapy .


Incidences of bevacizumab-associated adverse events ( 19.7 % overall ) were consistent with those in randomized controlled trials of bevacizumab in NSCLC .


Results from ARIES demonstrate similar outcomes to randomized controlled trials of bevacizumab when added to standard chemotherapy in a real-world patient population with advanced NSCLC .


To evaluate effects of maropitant , acepromazine , and electroacupuncture on morphine-related signs of nausea and vomiting in dogs and assess sedative effects of the treatments .


Randomized controlled clinical trial .


222 dogs .


Dogs received 1 of 6 treatments : injection of saline ( 0.9 % NaCl ) solution , maropitant citrate , or acepromazine maleate or electroacupuncture treatment at 1 acupoint , 5 acupoints , or a sham acupoint .


Morphine was administered after 20 minutes of electroacupuncture treatment or 20 minutes after injectable treatment .


Vomiting and retching events and signs of nausea and sedation were recorded .


Incidence of vomiting and retching was significantly lower in the maropitant ( 14/37 [ 37.8 % ] ) group than in the saline solution ( 28/37 [ 75.7 % ] ) and sham-acupoint electroacupuncture ( 32/37 [ 86.5 % ] ) groups .


The number of vomiting and retching events in the maropitant ( 21 ) , acepromazine ( 38 ) , 1-acupoint ( 35 ) , and 5-acupoint ( 34 ) groups was significantly lower than in the saline solution ( 88 ) and sham-acupoint electroacupuncture ( 109 ) groups .


Incidence of signs of nausea was significantly lower in the acepromazine group ( 3/37 [ 8.1 % ] ) than in the sham-acupoint group ( 15/37 [ 40.5 % ] ) .


Mean nausea scores for the saline solution , maropitant , and sham-acupoint electroacupuncture groups increased significantly after morphine administration , whereas those for the acepromazine , 1-acupoint electroacupuncture , and 5-acupoint electroacupuncture groups did not .


Mean sedation scores after morphine administration were significantly higher in dogs that received acepromazine than in dogs that received saline solution , maropitant , and sham-acupoint electroacupuncture treatment .


Maropitant treatment was associated with a lower incidence of vomiting and retching , compared with control treatments , and acepromazine and electroacupuncture appeared to prevent an increase in severity of nausea following morphine administration in dogs .


Over-diagnosis of malaria among African children results in mismanagement of non-malaria infections .


Limited laboratory capacity makes it difficult to implement policies that recommend pre-treatment confirmation of infections so a new approach with a package for on-the-spot management of fevers was evaluated .


Febrile children presenting to outpatient clinic were randomized to receive either a ` test-treat ' package ( history with clinical examination ; point-of-care tests ; choice of artesunate-amodiaquine , co-amoxiclav and/or paracetamol ) or routine outpatient care in a secondary health care facility in Kumasi , Ghana .


A diagnosis of malaria , bacterial , viral or mixed malarial and bacterial infections was made using pre-defined criteria .


Outcome was resolution of all symptoms including fever on day 7 .


The median age of the patients was 37.5 months ( IQR : 19 to 66 months ) , with 56.7 % being males .


Compared to routine care the test-treat package resulted in less diagnoses of malaria , ( 37.2 % vs 46.2 % , p = 0.190 ) and mixed malaria and bacterial infections ( 14.0 % vs 53.8 % , p < 0.001 ) but more diagnoses of viral ( 33.1 % vs 0.0 % , p < 0.001 ) and bacterial infections only ( 15.7 % vs 0.0 % , p < 0.001 ) .


Less anti-malarials ( 51.2 % vs 100.0 % , p < 0.001 ) and antibiotics ( 29.7 % vs 48.7 % , p < 0.001 ) , were prescribed in the test-treat group on completion of study , more test-treat package patients were clinically well ( 99.2 % vs 80.7 % , p < 0.001 ) and febrile ( 0.8 % vs 10.1 % , p = 0.001 ) and less were admitted for inpatient care ( 0.0 % vs 8.4 % p = 0.001 ) compared to the routine care group .


Test-treat package improves the effectiveness of outpatient diagnosis and treatment of children with fever and reduces inappropriate prescribing of anti-malarials and antibiotics .


The package provides clinicians with the option for immediate diagnosis and treatment of non-malaria fevers .


The test-treat package now needs to be evaluated in other settings including primary health care facilities .


The 2007 American College of Cardiologists/American Heart Association Guidelines on Perioperative Cardiac Evaluation and Care for Noncardiac Surgery is the standard for perioperative cardiac evaluation .


Recent work has shown that residents and anesthesiologists do not apply these guidelines when tested .


This research hypothesized that a decision support tool would improve adherence to this consensus guideline .


Anesthesiology residents at four training programs participated in an unblinded , prospective , randomized , cross-over trial in which they completed two tests covering clinical scenarios .


One quiz was completed from memory and one with the aid of an electronic decision support tool .


Performance was evaluated by overall score ( % correct ) , number of incorrect answers with possibly increased cost or risk of care , and the amount of time required to complete the quizzes both with and without the cognitive aid .


The primary outcome was the proportion of correct responses attributable to the use of the decision support tool .


All anesthesiology residents at four institutions were recruited and 111 residents participated .


Use of the decision support tool resulted in a 25 % improvement in adherence to guidelines compared with memory alone ( P < 0.0001 ) , and participants made 77 % fewer incorrect responses that would have resulted in increased costs .


Use of the tool was associated with a 3.4-min increase in time to complete the test ( P < 0.001 ) .


Use of an electronic decision support tool significantly improved adherence to the guidelines as compared with memory alone .


The decision support tool also prevented inappropriate management steps possibly associated with increased healthcare costs .


To examine the relationships between stressful life events and physiological measures , adherence to prescribed oral medication regimens , depressive symptoms , and impaired quality of life ( QoL ) in adolescents with recent-onset type 2 diabetes ( T2D ) .


Data were collected from 497 ethnically diverse participants ( 66 % female ) in the final year of the Treatment Options for Type 2 Diabetes in Adolescents and Youth multicenter clinical trial .


Exposure to 32 possible events over the previous year and rating of subsequent distress were collected by self-report and summarized as a major stressors score .


This score was analyzed for relationship to glycemic control ( hemoglobin A1c and treatment failure ) , body mass index , diagnosis of hypertension or triglyceride dyslipidemia , adherence to a prescribed oral medication regimen , presence of depressive symptoms , and impaired QoL .


The total number of major stressful life events in the adolescents with T2D was calculated , with 33 % reporting none , 67 % reporting 1 , 47 % reporting 2 , 33 % reporting 3 , and 20 % reporting 4 .


There were no associations between the major stressors score and physiological measures or diagnosis of comorbidities .


The odds of medication nonadherence increased significantly from those reporting 1 major stressor ( OR , 1.58 ; P = .0265 ) to those reporting 4 major stressors ( OR , 2.70 ; P = .0009 ) .


Significant odds of elevated depressive symptoms and impaired QoL were also found with increased reporting of major stressors .


Exposure to major stressful life events is associated with lower adherence to prescribed oral medication regimens and impaired psychosocial functioning in adolescents with T2D .


Low back pain ( LBP ) is responsible for more than 2.5 million visits to US emergency departments ( EDs ) annually .


These patients are usually treated with nonsteroidal anti-inflammatory drugs , acetaminophen , opioids , or skeletal muscle relaxants , often in combination .


To compare functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP among patients randomized to a 10-day course of ( 1 ) naproxen + placebo ; ( 2 ) naproxen + cyclobenzaprine ; or ( 3 ) naproxen + oxycodone/acetaminophen .


This randomized , double-blind , 3-group study was conducted at one urban ED in the Bronx , New York City .


Patients who presented with nontraumatic , nonradicular LBP of 2 weeks ' duration or less were eligible for enrollment upon ED discharge if they had a score greater than 5 on the Roland-Morris Disability Questionnaire ( RMDQ ) .


The RMDQ is a 24-item questionnaire commonly used to measure LBP and related functional impairment on which 0 indicates no functional impairment and 24 indicates maximum impairment .


Beginning in April 2012 , a total of 2588 patients were approached for enrollment .


Of the 323 deemed eligible for participation , 107 were randomized to receive placebo and 108 each to cyclobenzaprine and to oxycodone/acetaminophen .


Follow-up was completed in December 2014 .


All participants were given 20 tablets of naproxen , 500 mg , to be taken twice a day .


They were randomized to receive either 60 tablets of placebo ; cyclobenzaprine , 5 mg ; or oxycodone , 5 mg/acetaminophen , 325 mg .


Participants were instructed to take 1 or 2 of these tablets every 8 hours , as needed for LBP .


They also received a standardized 10-minute LBP educational session prior to discharge .


The primary outcome was improvement in RMDQ between ED discharge and 1 week later .


Demographic characteristics were comparable among the 3 groups .


At baseline , median RMDQ score in the placebo group was 20 ( interquartile range [ IQR ] ,17 -21 ) , in the cyclobenzaprine group 19 ( IQR,17-21 ) , and in the oxycodone/acetaminophen group 20 ( IQR,17-22 ) .


At 1-week follow-up , the mean RMDQ improvement was 9.8 in the placebo group , 10.1 in the cyclobenzaprine group , and 11.1 in the oxycodone/acetaminophen group .


Between-group difference in mean RMDQ improvement for cyclobenzaprine vs placebo was 0.3 ( 98.3 % CI , -2.6 to 3.2 ; P = .77 ) , for oxycodone/acetaminophen vs placebo , 1.3 ( 98.3 % CI , -1.5 to 4.1 ; P = .28 ) , and for oxycodone/acetaminophen vs cyclobenzaprine , 0.9 ( 98.3 % CI , -2.1 to 3.9 ; P = .45 ) .


Among patients with acute , nontraumatic , nonradicular LBP presenting to the ED , adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up .


These findings do not support use of these additional medications in this setting .


clinicaltrials.gov Identifier : NCT01587274 .


To improve survival rates in children with acute myeloid leukemia ( AML ) , we evaluated gemtuzumab-ozogamicin ( GO ) , a humanized immunoconjugate targeted against CD33 , as an alternative to further chemotherapy dose escalation .


Our primary objective was to determine whether adding GO to standard chemotherapy improved event-free survival ( EFS ) and overall survival ( OS ) in children with newly diagnosed AML .


Our secondary objectives examined outcomes by risk group and method of intensification .


Children , adolescents , and young adults ages 0 to 29 years with newly diagnosed AML were enrolled onto Childrens Oncology Group trial AAML0531 and then were randomly assigned to either standard five-course chemotherapy alone or to the same chemotherapy with two doses of GO ( 3 mg/m2/dose ) administered once in induction course 1 and once in intensification course 2 ( two of three ) .


There were 1,022 evaluable patients enrolled .


GO significantly improved EFS ( 3 years : 53.1 % v. 46.9 % ; hazard ratio [ HzR ] , 0.83 ; 95 % CI , 0.70 to 0.99 ; P. 04 ) but not OS ( 3 years : 69.4 % v. 65.4 % ; HzR , 0.91 ; 95 % CI , 0.74 to 1.13 ; P = .39 ) .


Although remission was not improved ( 88 % v. 85 % ; P = .15 ) , posthoc analyses found relapse risk ( RR ) was significantly reduced among GO recipients overall ( 3 years : 32.8 % v. 41.3 % ; HzR , 0.73 ; 95 % CI , 0.58 to 0.91 ; P = .006 ) .


Despite an increased postremission toxic mortality ( 3 years : 6.6 % v. 4.1 % ; HzR , 1.69 ; 95 % CI , 0.93 to 3.08 ; P = .09 ) , disease-free survival was better among GO recipients ( 3 years : 60.6 % v. 54.7 % ; HzR , 0.82 ; 95 % CI , 0.67 to 1.02 ; P = .07 ) .


GO added to chemotherapy improved EFS through a reduction in RR for children and adolescents with AML .


Fatigue is one of many unintended consequences of shift work in the nursing profession .


Natural health products ( NHPs ) for fatigue are becoming an increasingly popular topic of clinical study ; one such NHP is Rhodiola rosea .


A well-designed , rigorously conducted randomized controlled trial is required before therapeutic claims for this product can be made .


To compare the efficacy of R. rosea with placebo for reducing fatigue in nursing students on shift work .


A parallel-group randomized , double-blinded , placebo-controlled trial of 18-55 year old students from the Faculty of Nursing from the University of Alberta , participating in clinical rotations between January 2011 and September 2011 .


Participants were randomized to take 364 mg of either R. rosea or identical placebo at the start of their wakeful period and up to one additional capsule within the following four hours on a daily basis over a 42-day period .


The primary outcome was reduction in fatigue over the 42-day trial period measured using the Vitality-subscale of the RAND-36 , cross-validated by the visual analogue scale for fatigue ( VAS-F ) .


Secondary outcomes included health-related quality of life , individualized outcomes assessment , and adverse events .


A total of 48 participants were randomized to R. rosea ( n = 24 ) or placebo ( n = 24 ) .


The mean change in scores on the Vitality-subscale was significantly different between the study groups at day 42 in favor of placebo ( -17.3 ( 95 % CI -30.6 , -3.9 ) , p = 0.011 ) , The mean change in scores on the VAS-F was also significantly difference between study groups at day 42 in favour of placebo ( 1.9 ( 95 % CI 0.4 , 3.5 ) , p = 0.015 ) .


Total number of adverse events did not differ between R. rosea and placebo groups .


This study indicates that among nursing students on shift work , a 42-day course of R. Rosea compared with placebo worsened fatigue ; however , the results should be interpreted with caution .


Clinicaltrials.gov NCT01278992 .


Stroke is one of the most common causes of cognitive impairment .


Up to 75 % of stroke survivors may be considered to have cognitive impairment , which severely limit individual autonomy for successful reintegration into family , work and social life .


The clinical efficacy of acupuncture with Baihui ( DU20 ) and Shenting ( DU24 ) in stroke and post-stroke cognitive impairment has been previously demonstrated .


Computer-assisted cognitive training is part of conventional cognitive rehabilitation and has also shown to be effective in improvement of cognitive function of affected patients .


However , the cognitive impairment after stroke is so complexity that one single treatment can not resolve effectively .


Besides , the effects of acupuncture and RehaCom cognitive training have not been systematically compared , nor has the possibility of a synergistic effect of combination of the two therapeutic modalities been evaluated .


Our primary aim of this trial is to evaluate the synergistic effect of acupuncture and RehaCom cognitive training on cognitive dysfunction after stroke .


A randomized controlled trial of 2 2 factorial design will be conducted in the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine .


A total of 240 patients with cognitive dysfunction after stroke who meet the eligibility criteria will be recruited and randomized into RehaCom training group , acupuncture group , a combination of both or control group in a 1:1:1:1 ratio .


All patients will receive conventional treatment .


The interventions will last for 12 weeks ( 30 min per day , Monday to Friday every week ) .


Evaluations will be conducted by blinded assessors at baseline and again at 4 , 8 and 12 weeks .


Outcome measurements include mini-mental state examination ( MMSE ) , Montreal cognitive assessments ( MoCA ) , functional independence measure scale ( FIM ) and adverse events .


The results of this trial are expected to clarify the synergistic effect of acupuncture and RehaCom cognitive training on cognitive dysfunction after stroke .


Furthermore , to confirm whether combined or alone of acupuncture and RehaCom cognitive training , is more effective than conventional treatment in the management of post-stroke cognitive dysfunction .


Chinese Clinical Trial Registry : ChiCTR-TRC-13003704 .


Anastomotic leakage of pancreaticojejunostomy ( PJ ) remains the single most important source of morbidity after pancreaticoduodenectomy ( PD ) .


The primary aim of this randomized clinical trial comparing PG with PJ after PD was to test the hypothesis that invaginated PG would result in a lower rate and severity of pancreatic fistula .


Patients undergoing PD were randomized to receive either a duct-to-duct PJ or a double-layer invaginated PG .


The primary endpoint was the rate of pancreatic fistula , using the definition of the International Study Group on Pancreatic Fistula .


Secondary endpoints were the evaluation of severe abdominal complications ( Clavien-Dindo grade IIIa or above ) , endocrine and exocrine function .


Of 123 patients randomized , 58 underwent PJ and 65 had PG .


The incidence of pancreatic fistula was significantly higher following PJ than for PG ( 20 of 58 versus 10 of 65 respectively ; P = 0.014 ) , as was the severity of pancreatic fistula ( grade A : 2 versus 5 per cent ; grade B-C : 33 versus 11 per cent ; P = 0.006 ) .


The hospital readmission rate for complications was significantly lower after PG ( 6 versus 24 per cent ; P = 0.005 ) , weight loss was lower ( P = 0.025 ) and exocrine function better ( P = 0.022 ) .


The rate and severity of pancreatic fistula was significantly lower with this PG technique compared with that following PJ .


ISRCTN58328599 ( http://www.controlled-trials.com ) .


Predictors of outcome after aneurysmal subarachnoid hemorrhage have been determined previously through hypothesis-driven methods that often exclude putative covariates and require a priori knowledge of potential confounders .


Here , we apply a data-driven approach , principal component analysis , to identify baseline patient phenotypes that may predict neurological outcomes .


Principal component analysis was performed on 120 subjects enrolled in a prospective randomized trial of clazosentan for the prevention of angiographic vasospasm .


Correlation matrices were created using a combination of Pearson , polyserial , and polychoric regressions among 46 variables .


Scores of significant components ( with eigenvalues > 1 ) were included in multivariate logistic regression models with incidence of severe angiographic vasospasm , delayed ischemic neurological deficit , and long-term outcome as outcomes of interest .


Sixteen significant principal components accounting for 74.6 % of the variance were identified .


A single component dominated by the patients ' initial hemodynamic status , World Federation of Neurosurgical Societies score , neurological injury , and initial neutrophil/leukocyte counts was significantly associated with poor outcome .


Two additional components were associated with angiographic vasospasm , of which one was also associated with delayed ischemic neurological deficit .


The first was dominated by the aneurysm-securing procedure , subarachnoid clot clearance , and intracerebral hemorrhage , whereas the second had high contributions from markers of anemia and albumin levels .


Principal component analysis , a data-driven approach , identified patient phenotypes that are associated with worse neurological outcomes .


Such data reduction methods may provide a better approximation of unique patient phenotypes and may inform clinical care as well as patient recruitment into clinical trials .


http://www.clinicaltrials.gov .


Unique identifier : NCT00111085 .


To evaluate the effects of an Al ( 3 + ) - and Mg ( 2 + ) - containing antacid , ferrous sulfate , and calcium carbonate on the absorption of nemonoxacin in healthy humans .


Two single-dose , open-label , randomized , crossover studies were conducted in 24 healthy male Chinese volunteers ( 12 per study ) .


In Study 1 , the subjects orally received nemonoxacin ( 500 mg ) alone , or an antacid ( containing 318 mg of Al ( 3 + ) and 496 mg of Mg ( 2 + ) ) plus nemonoxacin administered 2 h before , concomitantly or 4 h after the antacid .


In Study 2 , the subjects orally received nemonoxacin ( 500 mg ) alone , or nemonoxacin concomitantly with ferrous sulfate ( containing 60 mg of Fe ( 2 + ) ) or calcium carbonate ( containing 600 mg of Ca ( 2 + ) ) .


Concomitant administration of nemonoxacin with the antacid significantly decreased the area under the concentration-time curve from time 0 to infinity ( AUC0 - ) for nemonoxacin by 80.5 % , the maximum concentration ( Cmax ) by 77.8 % , and urine recovery ( Ae ) by 76.3 % .


Administration of nemonoxacin 4 h after the antacid decreased the AUC0 - for nemonoxacin by 58.0 % , Cmax by 52.7 % , and Ae by 57.7 % .


Administration of nemonoxacin 2 h before the antacid did not affect the absorption of nemonoxacin .


Administration of nemonoxacin concomitantly with ferrous sulfate markedly decreased AUC0 - by 63.7 % , Cmax by 57.0 % , and Ae by 59.7 % , while concomitant administration of nemonoxacin with calcium carbonate mildly decreased AUC0 - by 17.8 % , Cmax by 14.3 % , and Ae by 18.4 % .


Metal ions , Al ( 3 + ) , Mg ( 2 + ) , and Fe ( 2 + ) markedly decreased the absorption of nemonoxacin in healthy Chinese males , whereas Ca ( 2 + ) had much weaker effects .


To avoid the effects of Al ( 3 + ) and Mg ( 2 + ) - containing drugs , nemonoxacin should be administered 2 h before them .


This study was conducted to compare the effectiveness of PETTLEP-based imagery , and traditional imagery interventions , on performance of passing skill in volleyball .


36 beginners male volleyball players ( Mage = 13.5 years , SD = 0.55 years ) with 5-6 months practice experience were randomly assigned to one of three groups : physical practice + PETTLEP imagery ( PP+PI ) ( N. = 15 ) , physical practice + traditional imagery ( N. = 15 ) , and physical practice only ( PP ; N. = 15 ) .


Subjects in the PP+PI group applied the seven components of PETTLEP imagery training ; whereas subjects in the PP+TI engaged in a relaxation session before imagery and used response laden motor imagery scripts .


The two groups completed 15 minutes of imagery training followed immediately by 13 minutes of `` passing '' practice three times per week .


The PP group completed only 13 minutes of `` passing '' practice three times per week .


Each group performed its respective tasks for 7 weeks .


A pre-test took place during the first practice session in which `` passing '' was assessed .


After the 7-week practice program , a post-test took place followed by a retention test , one `` no-practice '' week later .


All groups improved significantly ( P < 0.05 ) from pre - to post-test and retention test .


However , as hypothesised the PP+PI group improved more ( P < 0.05 ) than the PP+TI and PP groups .


The findings , therefore , support the effectiveness of PETTLEP imagery in enhancing performance of passing skill in volleyball when combined with physical practice .


This multicenter , randomized , open-labeled , clinical trial evaluated the efficacy and safety of cisplatin/5-fluorouracil ( 5-FU ) hepatic arterial infusion chemotherapy ( CF-HAIC ) versus adriamycin adding to CF-HAIC ( ACF-HAIC ) in advanced HCC patients .


Fifty-six patients with advanced HCC were randomized to two treatment groups : ( 1 ) CF-HAIC group [ n = 29 , 5-FU , 500 mg/m ( 2 ) on days 1-3 , and cisplatin , 60 mg/m ( 2 ) on day 2 ] and ( 2 ) ACF-HAIC group [ n = 27 , adriamycin , 50 mg/m ( 2 ) on day 1 , 5-FU , 500 mg/m ( 2 ) on days 1-3 , and cisplatin , 60 mg/m ( 2 ) on day 2 ] every 4 weeks via an implantable port system .


Primary efficacy endpoint was overall survival ( OS ) .


Treatment response and time to progression were secondary endpoints .


Treatment response rates did not differ significantly between the two treatment groups .


Time to progression ( 5.4 vs. 5.8 months , P = 0.863 ) and OS ( 11.1 vs. 8.8 months , P = 0.448 ) were not significantly different .


When the factors affecting patient OS were analyzed , disease control rate [ P < 0.001 , HR 6.437 ( 95 % CI 2.580-16 .064 ) ] was independently associated with OS .


Age ( 60 years ) and serum AFP level ( 200 ng/dL ) also were significant factors for OS [ P = 0.007 , HR 4.945 ( 95 % CI 1.543-15 .850 ) , P = 0.048 , HR 2.677 ( 95 % CI 1.010-7 .095 ) , respectively ] .


Grade 4 treatment-related toxicity and mortality was not observed in both groups .


Although both HAIC regimens are safe and effective in patients with advanced HCC , HAIC adding adriamycin did not show delayed tumor progression and survival benefit compared to CF-HAIC in advanced HCC .


To assess the effectiveness and safety on post-stroke dysphagia in chronic stage treated with magnetic-ball sticking therapy at the auricular points .


Ninety cases of post-apoplexy dysphagia in chronic stage were randomized into an auricular points group and an acupuncture group .


In the auricular points group , the magnetic-ball sticking therapy was applied to subcortex ( pizhixia , AT4 ) , brainstem ( naogan , AT ( 3,4 i ) ) , mouth ( kou , CO1 ) , cheek ( mianjia , LO ( 5,6 i ) ) , tongue ( she , LO2 ) and throat ( yanhou , TG3 ) on one ear each time , and were changed on the other ear once every 3 days .


In the acupucnture group , acupuncture was applied to Feng-chi ( GB 20 ) , Yifeng ( TE 17 ) , Shanglianquan ( Extra ) , Jinjin ( EX-HN 12 ) , Yuye ( EX-HN 13 ) , Shuigou ( GV 26 ) and Tongli ( TH 5 ) , etc. .


The needles were retained for 30 min in each treatment .


The treatment was gi-yen once a day in the two groups and the treatment of 6 days made one session .


There was 1 day at an interval among the sessions .


Totally , 3 sessions of treatment were required .


The video fluoroscopic swallowing study ( VFSS ) was performed for 4 kinds of food with different properties and shapes in each patient .


The main indices were Rosenbek penetration-aspiration score , oral-retaining score and throat-retaining score .


The efficacy , and the incidences of aspiration pneumonia and malnutrition were compared between the two groups .


The nutrition indices were compared before and after treatment between the two groups , such as the skinfold thickness of triceps brachii muscle , serum albumin and peralbumin .


In 21 days of treatment , in the auricular points group , the 1 mL liquid loversol Rosenbek penetration-aspiration score ( 1.51 + / - 0.69 ) , oral-retaining score ( 1.17 + / - 0.38 ) and throat-retaining score ( 1.30 + / - 0.66 ) were all lower than those ( 2.51 + / - 0.67 , 1.63 + / - 0.72 , 1.67 + / - 0.7 ) in the acupuncture group separately .


The 10 mL liquid loversol Rosenbek penetration-aspiration score ( 2.27 + / - 0.65 ) , oral-retaining score ( 1.60 + / - 0.50 ) and throat-retaining score ( 1.49 + / - 0.51 ) were all lower than those ( 4.19 + / - 0.73 , 2.30 + / - 0.51 , 2.41 + / - 0.50 ) in the acupuncture group separately .


The 10 mL paste loversol Rosenbek penetration-aspiration score ( 1.68 + / - 0.81 ) , oral-retaining score ( 1.11 + / - 0.31 ) and throat-retaining score ( 1.10 + / - 0.31 ) were all lower than those ( 3.91 + / - 0.68 , 1.63 + / - 0.76 , 1.60 + / - 0.76 ) in the acupuncture group separately .


The 1/4 cake-form loversol Rosenbek penetration-aspiration score ( 2.60 + / - 0.65 ) , oral-retaining score ( 1.40 + / - 0.50 ) and throat-retaining score ( 1.74 + / - 0.49 ) were all lower than those ( 4.14 + / - 1.10 , 2.40 + / - 0.73 , 2.30 + / - 0.83 ) in the acupuncture group separately .


The incidence of aspiration pneumonia was 14.9 % ( 7/47 ) in the auricular points group , which was lower than 55.0 % ( 22/40 ) in the acupuncture group ( P < 0.01 ) .


The incidence of malnutrition was 8.5 % ( 4/47 ) in the auricular points group , which was lower than 50.0 % ( 20/40 ) in the acupuncture group ( P < 0.01 ) .


In 21 days of treatment , the results of the skinfold thickness of triceps brachii muscle and serum albumin in the auricular points group were better than those in the acupuncture group ( both P < 0.05 ) .


The magnetic-ball sticking therapy at auricular points achieves the definite efficacy on post-stoke dysphagia in chronic stage and decreases the incidences of aspiration pneumonia and malnutrition .


The efficacy of this therapy is better than acupuncture .


Several characteristics of bone-targeted agents are considered when making treatment decisions .


This study evaluated physicians ' therapy preferences for preventing skeletal-related events ( SREs ) in patients with bone metastases secondary to solid tumors .


A Web-enabled , discrete-choice experiment online survey was conducted among physicians who treated patients with bone metastases and solid tumors in the United States .


Respondents chose between pairs of hypothetical medications defined by combinations of six attributes at varying levels for two hypothetical patients .


Preference weights for attribute levels were estimated using a random-parameters logit model .


In total , 200 physicians completed the survey .


Their mean age was 52 years , 57 % were in practice for more than 15 years , 37 % were oncologists , and 65 % treated 10 or fewer patients with bone metastases weekly .


Out-of-pocket cost to patients was the most important attribute overall .


Among clinical outcomes , time to first SRE and risk of renal impairment were the most important attributes .


Statistically significant preferences were observed for all attribute levels for time to first SRE , risk of renal impairment , and mode of administration .


Predicted choice probability analysis showed that physicians preferred a hypothetical medication with attributes similar to those of denosumab over one with attributes similar to those of zoledronic acid .


Physicians indicated that clinical attributes are important when considering bone-targeting therapy for bone metastases , but consistent with the current health care landscape , patient out-of-pocket cost was the most important .


With health care costs being increasingly shifted to patients , physicians require accurate information about co-pays and assistance programs to avoid patients receiving less costly , yet potentially inferior , treatment .


Despite their positive motivation to quit , many smokers do not attempt to quit or relapse soon after their quit attempt .


This study investigated the predictors of successful and unsuccessful quit attempts among smokers motivated to quit smoking .


We conducted secondary data analysis among respondents motivated to quit within 6 months , randomized to the control group ( N = 570 ) of a Web-based smoking cessation intervention study .


Using chi-square tests and ANOVA with Tukey post hoc comparisons , we investigated baseline differences by smoking status ( successful quitter/relapse/persistent smoker ) assessed after 6 weeks ( N = 214 ) .


To identify independent predictors of smoking status , multivariate multinomial logistic regression analyses were conducted .


Successful quitters at 6-week follow-up ( 26 % ) had reported significantly higher baseline levels of self-efficacy than relapsers ( 45 % ) and persistent smokers ( 29 % ) .


Furthermore , both successful quitters and relapsers had reported a significantly higher baseline intention to quit than persistent smokers and successful quitters had reported significantly more preparatory planning at baseline than persistent smokers .


Results from regression analyses showed that smokers ' baseline intention to quit positively predicted quit attempts reported after 6 weeks , while self-efficacy positively predicted quit attempt success .


Different factors appear to play a role in predicting quit attempts and their success .


Whereas intention to quit only appeared to play a role in predicting quit attempts , self-efficacy was the main factor predicting quit attempt success .


More research is needed to determine the role of preparatory planning and plan enactment and to investigate whether these findings can be replicated on the long term .


AirSeal is a novel class of valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and carbon dioxide ( CO ) recirculation during laparoscopic surgery .


Comparison data to standard CO pressure pneumoperitoneum insufflators is scarce .


The aim of this study is to evaluate the potential advantages of AirSeal compared to a standard CO insufflator .


This is a single center randomized controlled trial comparing elective laparoscopic cholecystectomy , colorectal surgery and hernia repair with AirSeal ( group A ) versus a standard CO pressure insufflator ( group S ) .


Patients are randomized using a web-based central randomization and registration system .


Primary outcome measures will be operative time and level of postoperative shoulder pain by using the visual analog score ( VAS ) .


Secondary outcomes include the evaluation of immunological values through blood tests , anesthesiological parameters , surgical side effects and length of hospital stay .


Taking into account an expected dropout rate of 5 % , the total number of patients is 182 ( n = 91 per group ) .


All tests will be two-sided with a confidence level of 95 % ( P < 0.05 ) .


The duration of an operation is an important factor in reducing the patient 's exposure to CO pneumoperitoneum and its adverse consequences .


This trial will help to evaluate if the announced advantages of AirSeal , such as clear sight of the operative site and an exceptionally stable working environment , will facilitate the course of selected procedures and influence operation time and patients clinical outcome .


ClinicalTrials.gov NCT01740011 , registered 23 November 2012 .