Few scientific studies have examined movement-based embodied contemplative practices such as yoga and their effects on cognition .


The purpose of this randomized controlled trial was to examine the effects of an @-week Hatha yoga intervention on executive function measures of task switching and working memory capacity .


Community-dwelling older adults ( N = @ ; mean age = @ ) were randomized to one of two groups : a Hatha yoga intervention or a stretching-strengthening control .


Both groups participated in hour-long exercise classes @/week over the @-week study period .


All participants completed established tests of executive function including the task switching paradigm , n-back and running memory span at baseline and follow-up .


Analysis of covariances showed significantly shorter reaction times on the mixed and repeat task switching trials ( partial ( @ ) = @ , p < @ ) for the Hatha yoga group .


Higher accuracy was recorded on the single trials ( partial ( @ ) = @ , p < @ ) , the @-back condition of the n-back ( partial ( @ ) = @ , p < @ ) , and partial recall scores ( partial ( @ ) = @ , p < @ ) of running span task .


Following @ weeks of yoga practice , participants in the yoga intervention group showed significantly improved performance on the executive function measures of working memory capacity and efficiency of mental set shifting and flexibility compared with their stretching-strengthening counterparts .


Although the underlying mechanisms need to be investigated , these results demand larger systematic trials to thoroughly examine effects of yoga on executive function as well as across other domains of cognition , and its potential to maintain or improve cognitive functioning in the aging process .


Soluble ST@ ( sST@ ) , a biomarker related to inflammation , is associated with outcomes of patients with heart failure .


In-depth analyses of the relationship among sST@ , changes in sST@ , and patient outcomes are reported .


sST@ was measured at baseline ( n = @ ) , @ months ( n = @ ) , and @ months ( n = @ ) in Valsartan Heart Failure Trial .


Baseline sST@ averaged @ ng/mL , significantly ( P < @ ) higher in men than women but supranormal in only @ % and @ % , respectively .


A continuous relationship between sST@ and the log hazard ratio for outcomes was modeled as @ linear segments with a significant decrease in the rate of increase in hazard ratios > @ ng/mL .


Each segment of the sST@ distribution was significantly ( P < @ ) associated with the risks of morbid event , mortality , and hospitalization for heart failure .


Only sST@ values < @ ng/mL were significantly related to the outcomes when @ readily available clinical variables including N-terminal probrain natriuretic peptide were included in the Cox regression model .


sST@ did not improve discrimination of patient outcomes .


Compared with placebo , valsartan significantly ( P < @ ) reduced the rate of increase in sST@ .


Increases in sST@ for @ months , but not decreases , were significantly associated with subsequent outcomes , independent of clinical variables , sST@ , and valsartan treatment .


In this study , baseline sST@ was nonlinearly associated with patient outcomes but did not provide substantial prognostic information when added to a clinical prediction model that included N-terminal probrain natriuretic peptide .


An increase but not decrease in sST@ was independently associated with outcomes .


Additional research is needed to determine whether monitoring ST@ levels can improve patient outcomes .


The aim of the present study was to compare the effects of preemptive intravenous tenoxicam and methylprednisolone administrations on extraction of impacted third molars .


This was a placebo-controlled , randomized , double-blind , clinical trial .


A total of @ adult patients ages @-@ years with the complaints of impacted third molar teeth were included in the study .


The postoperative swelling ratios ( p < @ ) and pain scores ( p < @ ) were significantly better in both study groups than in the control group and there was no statistically significant difference between methylprednisolone and tenoxicam groups with regards to the edema and pain relief .


Preoperative administration of @ mg methylprednisolone achieves better control of trismus than tenoxicam without any significant differences in edema and pain control in impacted third molar teeth extraction .


GLP-@ receptor agonists may provide an alternative to prandial insulin for advancing basal insulin therapy .


Harmony @ was a randomized , open-label , active-controlled trial testing once-weekly albiglutide vs. thrice-daily prandial insulin lispro as an add-on to titrated once-daily insulin glargine .


Patients taking basal insulin ( with or without oral agents ) with HbA@c @-@ @ % ( @-@ mmol/mol ) entered a glargine standardization period , followed by randomization to albiglutide , @ mg weekly ( n = @ ) , subsequently uptitrated to @ mg , if necessary , or thrice-daily prandial lispro ( n = @ ) while continuing metformin and/or pioglitazone .


Glargine was titrated to fasting plasma glucose of < @ mmol/L , and lispro was adjusted based on glucose monitoring .


The primary end point was the difference in the HbA@c change from baseline at week @ .


At week @ , HbA@c decreased from baseline by -@ SE @ % ( @ mmol/mol ) with albiglutide and -@ @ % ( @ mmol/mol ) with lispro ; treatment difference , -@ % ( @ % CI -@ to @ ; @ mmol/mol ; P < @ ) , meeting the noninferiority end point ( margin , @ % ) .


Weight decreased with albiglutide but increased with lispro ( -@ @ kg vs. +@ @ kg ) .


The mean glargine dose increased from @ to @ IU ( albiglutide ) and from @ to @ IU ( lispro ) .


Adverse events for albiglutide versus lispro included severe hypoglycemia ( @ vs. @ events ) , documented symptomatic hypoglycemia ( @ % vs. @ % ) , nausea ( @ % vs. @ % ) , vomiting ( @ % vs. @ % ) , and injection site reactions ( @ % vs. @ % ) .


Weekly albiglutide is a simpler therapeutic option than thrice-daily lispro for advancing basal insulin glargine therapy , resulting in comparable HbA@c reduction with weight loss and lower hypoglycemia risk .


To present the long-term results of a prostate cancer ( PC ) screening trial conducted in a Mediterranean setting .


A total of @ men aged @-@ years were randomized to screening arm ( PSA test performed ) and control arm ( no tests ) .


Transrectal ultrasonography-guided sextant prostate biopsy was conducted when PSA > or = @ngml ( -@ ) .


Date and cause of death were retrieved from death certificates .


PC incidence , and disease-specific and overall mortality curves were plotted and comparison between arms was made .


Analysis of causes of death was also performed .


Median age at randomization was @ years .


Median follow-up time was @ years .


A total of @ men were diagnosed with PC , @ ( @ % ) in the screening arm and @ ( @ % ) in the control arm ( P < @ ) .


Eventually , @ men ( @ % ) died .


No difference in all-cause mortality was found between arms ( P = @ ) .


Only @ men ( @/@ , @ % ) died from PC , no differences between arms ( P = @ ) .


Overall , the main causes of death were malignancy ( @ % ) , cardiovascular ( @ % ) and respiratory ( @ % ) diseases .


Main cancer causes of death were lung and bronchus cancer ( @ % ) , colorectum ( @ % ) and stomach ( @ % ) cancer .


PC only accounted for @ % of all malignant causes of death ( ranked @th ) .


Our study failed to demonstrate benefits of PC screening in terms of all-cause and PC-specific mortality after a median follow-up of @ years .


The limited sample size and the low long-term PC mortality observed in our setting were probably the most important factors to explain these results .


The pathogenesis of perihematoma edema in intracerebral hemorrhage ( ICH ) is unknown but has been hypothesized to be ischemic .


In the ICH Acutely Decreasing Arterial Pressure Trial ( ICH ADAPT ) , perihematoma cerebral blood flow ( CBF ) was reduced but was unaffected by blood pressure ( BP ) reduction .


Using ICH ADAPT data , we tested the hypotheses that edema growth is associated with reduced CBF and lower systolic BP .


Noncontrast computed tomographic scans in patients with ICH were obtained at baseline , @ hours , and @ hours after randomization to target systolic BPs of < @ or < @ mm Hg .


Computed tomography perfusion imaging was performed at @ hours , and mean relative CBF was calculated in visibly edematous perihematoma tissue .


Edema volumes were measured using a Hounsfield unit threshold of @ to @ at each time-point .


Patients were randomized at a median ( interquartile range ) of @ ( @ ) hours after onset .


Treatment groups ( n = @ , < @ and n = @ , < @ target ) were balanced with respect to baseline systolic BP and acute ICH volume .


Relative edema growth at @ hours in the < @ group ( @ ) was similar to that in the < @ group ( @ mL ; P = @ ) .


Absolute CBF was lower in the edematous region ( @ mL/@ g per minute ) when compared with that in the contralateral tissue ( @ mL/@ g per minute ; P < @ ) .


Linear regression indicated that neither systolic BP change ( = -@ ; @ % confidence interval , -@ to @ ) nor perihematoma relative CBF ( = -@ ; @ % confidence interval , -@ to @ ) predicted edema growth .


Lower perihematoma CBF and BP treatment do not exacerbate edema growth .


These data do not support a cytotoxic edema pathogenesis .


Despite their wide use , whether antiarrhythmic drugs improve survival after out-of-hospital cardiac arrest ( OHCA ) is not known .


The ROC-ALPS is evaluating the effectiveness of these drugs for OHCA due to shock-refractory ventricular fibrillation or pulseless ventricular tachycardia ( VF/VT ) .


ALPS will randomize @,@ adults across North America with nontraumatic OHCA , persistent or recurring VF/VT after @ shock , and established vascular access to receive up to @ mg amiodarone , @ mg lidocaine , or placebo in the field using a double-blind protocol , along with standard resuscitation measures .


The designated target population is all eligible randomized recipients of any dose of ALPS drug whose initial OHCA rhythm was VF/VT .


A safety analysis includes all randomized patients regardless of their eligibility , initial arrhythmia , or actual receipt of ALPS drug .


The primary outcome of ALPS is survival to hospital discharge ; a secondary outcome is functional survival at discharge assessed as a modified Rankin Scale score @ .


The principal aim of ALPS is to determine if survival is improved by amiodarone compared with placebo ; secondary aim is to determine if survival is improved by lidocaine vs placebo and/or by amiodarone vs lidocaine .


Prioritizing comparisons in this manner acknowledges where differences in outcome are most expected based on existing knowledge .


Each aim also represents a clinically relevant comparison between treatments that is worth investigating .


Results from ALPS will provide important information about the choice and value of antiarrhythmic therapies for VF/VT arrest with direct implications for resuscitation guidelines and clinical practice .


Renal dysfunction is associated with a variety of cardiac alterations including left ventricular ( LV ) hypertrophy , LV dilation , and reduction in systolic and diastolic function .


It is common and associated with an increased mortality risk in heart failure ( HF ) patients .


This study was designed to evaluate whether severe diastolic dysfunction contribute to the increased mortality risk observed in HF patients with renal dysfunction .


Using Cox Proportional Hazard Models on data ( N = @ ) from the EchoCardiography and Heart Outcome Study ( ECHOS ) study we evaluated whether estimated glomerular filtration rate ( eGFR ) was associated with mortality risk before and after adjustment for severe diastolic dysfunction .


Severe diastolic dysfunction was defined by a restrictive left ventricular filling pattern ( RF ) ( = deceleration time < @ ms ) by Doppler echocardiography .


Median eGFR was @ ml/min/@ @ m , left ventricular ejection fraction was @ % and RF was observed in @ % .


During the @ year follow up period @ patients died .


Multivariable adjusted eGFR was associated with similar mortality risk before ( Hazard Ratio ( HR ) ( eGFR @ ml increase ) : @ ( @ % CI : @-@ @ , P = @ ) and after ( HR ( eGFR @ ml increase ) : @ ( @-@ @ ) , P = @ ) adjustment for RF ( HR : @ ( @-@ @ ) , P < @ ) .


In patients admitted with HF RF does not contribute to the increased mortality risk observed in patients with a decreased eGFR .


Factors other than severe diastolic dysfunction may explain the association between renal function and mortality risk in HF patients .


We investigated phenotypic and genotypic resistance after @ years of first-line therapy with two HIV treatment regimens in the absence of virological monitoring .


NORA -LSB- Nevirapine OR Abacavir study , a sub-study of the Development of AntiRetroviral Therapy in Africa ( DART ) trial -RSB- randomized @ symptomatic HIV-infected Ugandan adults ( CD@ cell count < @ cells/mm ( @ ) ) to receive zidovudine/lamivudine plus abacavir ( cABC arm ) or nevirapine ( cNVP arm ) .


All virological tests were performed retrospectively , including resistance tests on week @ plasma samples with HIV RNA levels @ copies/mL .


Phenotypic resistance was expressed as fold-change in IC ( @ ) ( FC ) relative to wild-type virus .


HIV-@ RNA viral load @ copies/mL at week @ was seen in @/@ ( @ % ) cABC participants and @/@ ( @ % ) cNVP participants .


Resistance results were available in @ cABC and @ cNVP participants ; @ ( @ % ) cABC and @ ( @ % ) cNVP isolates had a week @ FC below the biological cut-off for tenofovir ( @ ) .


In the cNVP arm , @/@ participants had resistance mutations synonymous with high-level resistance to nevirapine and efavirenz ; FC values for etravirine were above the biological cut-off in @ ( @ % ) isolates .


In multivariate regression models , K@R , Y@F and the presence of thymidine analogue-associated mutations were associated with increased susceptibility to etravirine in the cABC arm .


Our data support the use of tenofovir following failure of a first-line zidovudine-containing regimen and shed further light on non-nucleoside reverse transcriptase inhibitor hypersusceptibility .


Missed opportunities for human papilloma virus ( HPV ) vaccination are common , presenting a barrier to achieving widespread vaccine coverage and preventing infection .


To compare the impact of clinician - versus family-focused decision support , none , or both on captured opportunities for HPV vaccination .


Twelve-month cluster randomized controlled trial conducted in @-@ .


Adolescent girls aged @-@ years due for HPV Dose @ , @ , or @ receiving care at primary care practices .


Twenty-two primary care practices were cluster randomized to receive a three-part clinician-focused intervention ( educational sessions , electronic health record-based alerts , and performance feedback ) or none .


Within each practice , girls were randomized at the patient level to receive family-focused , automated , educational phone calls or none .


Randomization resulted in four groups : clinician-focused , family-focused , combined , or no intervention .


Standardized proportions of captured opportunities ( due vaccine received at clinician visit ) were calculated among girls in each study arm .


Analyses were conducted in @ .


Among @,@ adolescent girls and their @,@ visits ( @,@ preventive , @,@ acute ) , more HPV opportunities were captured at preventive than acute visits ( @ % vs @ % , p < @ ) .


At preventive visits , the clinician intervention increased captured opportunities by @ percentage points for HPV-@ and @ percentage points for HPV-@ ( p@ @ ) , but not HPV-@ .


At acute visits , the clinician and combined interventions significantly improved captured opportunities for all three doses ( p@ @ ) .


The family intervention was similar to none .


Results differed by practice setting ; at preventive visits , the clinician intervention was more effective for HPV-@ in suburban than urban settings , whereas at acute visits , the clinician intervention was more effective for all doses at urban practices .


Clinician-focused decision support is a more effective strategy than family-focused to prevent missed HPV vaccination opportunities .


Given the persistence of missed opportunities even in intervention groups , complementary strategies are needed .


This study is registered at clinicaltrials.gov NCT@ .


Short periods of muscle disuse , due to illness or injury , result in substantial skeletal muscle atrophy .


Recently , we have shown that a single session of neuromuscular electrical stimulation ( NMES ) increases muscle protein synthesis rates .


The aim was to investigate the capacity for daily NMES to attenuate muscle atrophy during short-term muscle disuse .


Twenty-four healthy , young ( @ @ year ) males participated in the present study .


Volunteers were subjected to @ days of one-legged knee immobilization with ( NMES ; n = @ ) or without ( CON ; n = @ ) supervised NMES sessions ( @-min sessions , twice daily ) .


Two days prior to and immediately after the immobilization period , CT scans and single-leg one-repetition maximum ( @RM ) strength tests were performed to assess quadriceps muscle cross-sectional area ( CSA ) and leg muscle strength respectively .


Furthermore , muscle biopsies were taken to assess muscle fibre CSA , satellite cell content and mRNA and protein expression of selected genes .


In CON , immobilization reduced quadriceps CSA by @ @ % ( P < @ ) and muscle strength by @ @ % ( P < @ ) .


In contrast , no significant muscle loss was detected following immobilization in NMES although strength declined by @ @ % ( P < @ ) .


Muscle MAFbx and MuRF@ mRNA expression increased following immobilization in CON ( P < @ and P = @ respectively ) , whereas levels either declined ( P < @ ) or did not change in NMES , respectively .


Immobilization led to an increase in muscle myostatin mRNA expression in CON ( P < @ ) , but remained unchanged in NMES .


During short-term disuse , NMES represents an effective interventional strategy to prevent the loss of muscle mass , but it does not allow preservation of muscle strength .


NMES during disuse may be of important clinical relevance in both health and disease .


Compared with goal-directed crystalloid therapy , goal-directed colloid therapy during high-risk surgery may improve postoperative outcome .


Whether intraoperative fluid therapy based on goal-directed protocol with different types of fluid has distinctive effects on brain relaxation and cerebral metabolism during craniotomy remains unclear .


Forty patients with supratentorial brain tumors undergoing craniotomy were randomly assigned to either a Ringer 's Lactate-based goal-directed group ( LR group , n = @ ) or a @ % hydroxyethyl starch-based goal-directed group ( HES group , n = @ ) .


The goal was achieved by maintaining a target stroke volume variation ( SVV < @ % ) by volume loading with LR or HES throughout the procedure .


The primary outcome is brain relaxation scales , an indirect evaluation of ICP ; secondary endpoints include cerebral metabolism variables ( jugular venous oxygen saturation -LSB- SjvO ( @ ) -RSB- , arterial-jugular venous differences in oxygen -LSB- CajvO ( @ ) -RSB- , glucose -LSB- A-JvGD -RSB- , lactate -LSB- A-JvLD -RSB- , and cerebral extraction ratio for oxygen -LSB- CERO ( @ ) -RSB- ) and fluid volumes .


There is no significant difference between the LR and HES groups on brain relaxation scales ( P = @ ) , or measures of cerebral oxygenation and metabolism .


Intragroup comparisons showed that CERO ( @ ) increased by @ % ( P = @ , LR group ) and @ % ( P = @ , HES group ) , respectively , and SjvO ( @ ) was decreased by @ % ( P = @ , LR group ) and @ % ( P = @ , HES group ) , respectively , after tumor removal , compared with baseline .


During surgery , the LR group ( @ mL ) received more fluid than the HES group ( @ mL , P = @ ) .


In patients undergoing supratentorial tumor resection , goal-directed HES therapy was not superior to goal-directed LR therapy for brain relaxation or cerebral metabolism , although less fluid was needed to maintain the target SVV in the HES-based group than in the LR-based group .


Clefting of the lip , palate , or both is a common congenital abnormality .


Inadequate treatment for pain in children may result from concerns over opioid-related adverse effects .


Providing adequate pain control with minimal adverse effects remains challenging in children .


To assess opioid-sparing effects of oral or intravenous acetaminophen following primary cleft palate repair in children .


Prospective randomized controlled trial in @ healthy children , ages @months to @years , using standardized general anesthesia and lidocaine infiltration of the operative field .


Patients were allocated to groups : intravenous acetaminophen/oral placebo ( intravenous ) , oral acetaminophen/intravenous placebo ( oral ) , or intravenous/oral placebo ( control ) .


Groups were compared for differences in opioid administration during the @-h study period ( morphine equivalents gkg ( -@ ) ; @ % confidence interval ) .


Intravenous acetaminophen decreased opioid requirement after surgery ( P = @ ) .


Patients in the intravenous group received less opioid ( @ ; @-@ @ gkg ( -@ ) ) than control patients ( @ ; @-@ @ gkg ( -@ ) ; P < @ ) .


Opioid requirement in oral patients ( @ ; @-@ @ gkg ( -@ ) ) was intermediate and not significantly different from either intravenous ( P = @ ) or control ( P = @ ) .


During the ward phase of care , intravenous had better analgesia than control ( P = @ ) , and both intravenous and oral group patients received less opioid than control ( P = @ ) .


Intravenous acetaminophen given to young children undergoing primary cleft palate repair was associated with opioid-sparing effects compared to placebo .


The fewer morphine doses during ward stay in both intravenous and oral may be important clinically in some settings .


The aim of the study was to evaluate the durability of efficacy of the Integrated Care ( IC ) program in a Swedish context .


The IC program is a person-centered flexible assertive community treatment approach delivered through a novel mechanism : a resource group clinical microsystem for each patient .


All patients with schizophrenia in a Gothenburg urban-sector catchment area were randomly assigned to either the IC or the Rational Rehabilitation ( RR ) programs .


Sixty-six patients were interviewed and assessed by independent interviewers before treatment , after treatment ( @ months ) , and at follow-up ( five years ) .


Analysis was by intention to treat .


At the five-year follow-up , significant improvements were noted in social functioning and consumer satisfaction in the IC group ( N = @ ) compared with the RR group ( N = @ ) .


No patients were lost to services in either program .


The major finding was the durability of efficacy of the IC program .


Statins are known to possess pleiotropic anti-inflammatory properties which have been evaluated for clinical benefits in a number of disorders .


Studies have demonstrated beneficial actions of statins in experimental models of colitis .


Clinical evidence in acute exacerbation of ulcerative colitis ( UC ) is lacking .


This study aims to assess the efficacy and safety of add-on atorvastatin in mild to moderately severe acute exacerbation of UC .


Patients with acute exacerbation of UC were randomized to receive either atorvastatin ( @ mg ) or matching placebo once daily orally for @ weeks in addition to the standard therapy .


Clinical efficacy was assessed by using partial Mayo score ( PMS ) .


Previously diagnosed @ cases of UC presenting with mild to moderately severe acute exacerbation were randomized to receive either atorvastatin of @ mg or placebo .


Mean PMS increased by @ points and decreased by @ points in atorvastatin and placebo groups , respectively , at @ weeks compared to the baseline values ( p = @ ) .


Eight ( @ % ) and @ ( @ % ) patients attained the primary outcome criteria for clinical improvement in the atorvastatin and placebo arms , respectively ( p = @ ) .


Fifteen ( @ % ) patients in the atorvastatin group and no patient in the placebo group had @ point increase in PMS after @ weeks ( p < @ ) .


Atorvastatin therapy in acute exacerbation of UC may not be associated with beneficial effects .


Paradoxical increase in disease activity may be seen in some patients .


However , these findings need to be substantiated in larger studies .


The high prevalence of sleep disorders highlights the importance of its treatment in hemodialysis patients .


Due to complications of hypnotic medications , considering effective nonpharmacological methods to improve sleep quality is important .


This study has conducted to determine the effect of a sleep hygiene training program on sleep quality of hemodialysis patients .


In a randomized controlled clinical trial , @ hemodialysis patients were randomly selected and allocated to the intervention ( n = @ ) and control ( n = @ ) groups .


A @-month sleep hygiene program was provided to the intervention group within @ sessions , and the sleep quality was assessed by the Pittsburgh Sleep Quality Index before and after the intervention .


The global and components scores were compared between the two groups .


The mean global scores and component scores of sleep quality were not significantly different between the two groups before the intervention .


The mean global score of sleep quality of the intervention group significantly reduced after sleep hygiene education , as compared to the baseline values .


The mean global score of the intervention group was significantly lower than that of the control group after the intervention ( intervention , @ + / - @ versus control , @ + / - @ ) .


Also , the mean scores subjective sleep quality , sleep latency , sleep disturbances , and daytime dysfunction were significantly lower in the intervention group .


The findings of this study suggest that nursing and physicians team should consider reducing sleep problems of hemodialysis patients by training sleep hygiene .


Decision aids may improve informed consent in clinical trial recruitment , but have not been evaluated in this context .


This study investigated whether decision aids ( DAs ) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II ( IBIS-II ) trial .


The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts : women with increased risk ( Prevention ) , and women treated for ductal carcinoma in situ ( DCIS ) .


Australia , New Zealand and United Kingdom participants were randomised to receive a DA ( DA group ) or standard trial consent materials ( control group ) .


Questionnaires were completed after deciding about participation in IBIS-II ( post decision ) and @ months later ( follow-up ) .


Data from @ Prevention and @ DCIS participants were analysed post decision ( @ DA ; @ control ) ; @ Prevention and @ DCIS participants were analysed at follow-up ( @ DA ; @ control ) .


There was no effect on the primary outcome of decisional conflict .


The DCIS-DA group had higher knowledge post decision , and the Prevention-DA group had lower decisional regret at follow-up .


This was the first study to evaluate a DA in the clinical trial setting .


The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation .


This randomized , single center , examiner-blind , controlled , parallel-group , @-month clinical study compared the antiplaque/antigingivitis potential of an essential oil ( EO ) versus a @ % cetylpyridinium chloride ( CPC ) - containing mouthrinse .


A @ % hydroalcohol solution was included as a control group .


@ healthy volunteers ( @-@ years of age ) were enrolled in this clinical trial ; @ subjects completed the study .


At baseline , @ - , @ - , and @-month visits , subjects received an oral examination , gingivitis ( MGI ) , gingival bleeding ( BI ) and plaque assessments ( PI ) .


Following randomization , subjects received a prophylaxis and began brushing twice daily with the provided fluoride toothpaste and rinsing twice daily with @ mL of the assigned mouthrinse for @ seconds .


All rinses were well tolerated by the subjects , with the exception of extrinsic tooth stain complaints in @ subjects in the CPC group between the @ - and @-month exams .


Statistically significant reductions in gingivitis , bleeding and plaque were observed for both EO and CPC at all post-baseline time-points when compared to the negative control .


At @ months MGI and PI were reduced by @ % and @ % for EO and by @ % and @ % respectively , for CPC vs. control .


When compared to CPC , EO was statistically significantly superior at all post-baseline time-points .


EO showed increasing reductions in MGI of @ % , @ % and @ % as well as reductions in PI of @ % , @ % and @ % at @ , @ and @ months , respectively .


When analyzing the number of healthy sites ( MGI scores of @ or @ ) , the beneficial effect of the EO-containing mouthrinse is @ % greater than using a CPC-containing mouthrinse and @ % greater than placebo .


Genome-wide association studies identified that insulin-like growth factor @ mRNA-binding protein @ ( IGF@BP@ ) genetic polymorphisms are related to type @ diabetes mellitus ( T@DM ) in several populations .


This study aimed to investigate whether the IGF@BP@ gene rs@ and rs@ polymorphisms were associated with T@DM and pioglitazone efficacy in Chinese T@DM patients .


A total of @ T@DM patients and @ healthy volunteers were enrolled to identify the IGF@BP@ gene rs@ and rs@ polymorphisms ; @ patients were randomly selected and given a @-week pioglitazone treatment ( @ mg/day ) .


Fasting plasma glucose , postprandial plasma glucose ( PPG ) , glycated hemoglobin , serum triglycerides ( TG ) , total cholesterol , low-density lipoprotein cholesterol and high-density lipoprotein cholesterol ( HDL-C ) were determined before and after pioglitazone treatment .


The results showed that the IGF@BP@ gene rs@ and rs@ polymorphisms were associated with T@DM in a Chinese population ( OR = @ , @ % CI @-@ @ , p < @ ; OR = @ , @ % CI @-@ @ , p < @ ) .


The effect of pioglitazone on PPG ( p < @ ) , TG ( p < @ ) and HDL-C ( p < @ ) was lower in patients with the rs@ AC+CC genotypes than in AA genotype carriers .


Its effect on PPG level was also lower in patients with the GT+TT genotypes of rs@ than in patients with the GG genotype ( p < @ ) .


The IGF@BP@ gene rs@ and rs@ polymorphisms were associated with T@DM and therapeutic efficacy of pioglitazone in this Chinese population .


The aim of this study was to evaluate the efficacy and safety of zoledronic acid ( ZA ) in the combination of docetaxel-based chemotherapy for castration-resistant prostate cancer with bone metastases .


We conducted a prospective study in recruiting @ prostate cancer patients with bone metastases from @ to @ .


Patients were randomly divided into two groups , @ in the docetaxel-based chemotherapy + ZA ( Group A ) and @ in the docetaxel-based chemotherapy + placebo ( Group B ) .


The different outcome between patients treated with chemotherapy combined with ZA and those with chemotherapy alone was evaluated .


The Cox multivariate analyses of clinical features and different treatment methods of the @ patients were conducted .


There was a response of prostate-specific antigen ( PSA ) in @ ( @ % ) in Group A and @ ( @ % ) in Group B ( P = @ ) .


The combined approach group had better bone progression-free survival ( BPFS ) ( @ vs. @ months , P < @ ) and overall survival ( OS ) ( @ vs. @ months , P = @ ) , but no statistical evidence of benefit was observed in terms of PSA response .


Cox multivariate analysis identified the following independent prognostic factors : received ZA , high Hb level and more than @ cycles of chemotherapy .


There were no clinical relevant differences in the frequencies of adverse events between these two groups .


Zoledronic acid treatment combined with docetaxel-based chemotherapy could have a better bone pain control and improve BPFS and OS for prostate cancer patients with bone metastases .


The PSA response and SREs rate are similar .


The aim of this study was to examine the effects of testosterone on verbal learning and memory in postmenopausal women .


Randomized , placebo-controlled trial in which participants were randomized ( @:@ ) to transdermal testosterone gel @mcg/day , or identical placebo , for @weeks .


Ninety-two postmenopausal women aged @-@years , on no systemic sex hormone therapy .


The primary outcome was the score for the International Shopping List Task ( ISLT ) of CogState .


Secondary outcomes included other CogState domains , the Psychological General Well-Being Index ( PGWB ) and safety variables .


Eighty-nine women , median age @years , were included in the primary analysis .


Testosterone treatment resulted in statistically significantly better performance for the ISLT ( improved verbal learning and memory ) compared with placebo , adjusted for age and baseline score ( mean difference @ ; @ % CI @ , @ ) P = @ ) .


There were no significant differences for other CogState domains or the PGWB scores .


At @weeks , the median total testosterone was @nm ( interquartile range ( IQR ) @ , @ ) in the testosterone group and @nm ( IQR @ , @ ) in the placebo group .


The small but statistically significant effect of testosterone treatment on verbal learning and memory in postmenopausal women provides the basis for further clinical trials .


The objective was to determine the effect of preconception-initiated daily low-dose aspirin ( LDA ; @ mg/day ) treatment on time to pregnancy in women with a history of pregnancy loss .


This was a multicenter , block-randomized , double-blind , placebo-controlled trial .


Participants were block-randomized by center and eligibility stratum .


The study was conducted at four U.S.A. medical centers ( @-@ ) .


Participants women aged @-@ years actively attempting pregnancy , stratified by eligibility criteria : the `` original '' stratum , women with one loss < @ weeks ' gestation during the previous year ; and the `` expanded '' stratum , women with one or two previous losses of any gestational age regardless of time since loss .


Daily LDA was compared with matching placebo for up to six menstrual cycles of attempting pregnancy .


Time to hCG detected pregnancy and clinically confirmed pregnancy , analyzed by intention-to-treat , was measured .


Of the @ women randomly assigned to LDA ( n = @ ) or placebo ( n = @ ) , @ ( @ % ) women receiving LDA achieved pregnancy compared to @ ( @ % ) receiving placebo , corresponding to a fecundability odds ratio ( FOR ) of @ ( @ % CI : @ , @ ) .


Among women in the original stratum ( n = @ ) , LDA was associated with increased fecundability compared to placebo ( FOR : @ ; @ % CI : @ , @ ) .


Preconception-initiated LDA treatment resulted in a nonsignificant increase in fecundability of @ % in women with a history of @-@ pregnancy losses , and a significant increase of @ % in women with a history of only one pregnancy loss of < @ weeks ' gestation in the preceding year .


Preconception-initiated LDA may increase fecundability in certain women with a recent early pregnancy loss .


Amrubicin , a third-generation anthracycline and potent topoisomerase II inhibitor , showed promising activity in small-cell lung cancer ( SCLC ) in phase II trials .


This phase III trial compared the safety and efficacy of amrubicin versus topotecan as second-line treatment for SCLC .


A total of @ patients with refractory or sensitive SCLC were randomly assigned at a ratio of @:@ to @-day cycles of amrubicin @ mg/m ( @ ) intravenously ( IV ) on days @ to @ or topotecan @ mg/m ( @ ) IV on days @ to @ .


Primary end point was overall survival ( OS ) ; secondary end points included overall response rate ( ORR ) , progression-free survival ( PFS ) , and safety .


Median OS was @ months with amrubicin versus @ months with topotecan ( hazard ratio -LSB- HR -RSB- , @ ; P = @ ) ; in refractory patients , median OS was @ and @ months , respectively ( HR , @ ; P = @ ) .


Median PFS was @ months with amrubicin and @ months with topotecan ( HR , @ ; P = @ ) .


ORR was @ % with amrubicin and @ % with topotecan ( odds ratio , @ ; P < @ ) .


Grade @ treatment-emergent adverse events in the amrubicin and topotecan arms were : neutropenia ( @ % v @ % ; P = @ ) , thrombocytopenia ( @ % v @ % ; P < @ ) , anemia ( @ % v @ % ; P < @ ) , infections ( @ % v @ % ; P = @ ) , febrile neutropenia ( @ % v @ % ; P = @ ) , and cardiac disorders ( @ % v @ % ; P = @ ) ; transfusion rates were @ % and @ % ( P < @ ) , respectively .


NQO@ polymorphisms did not influence safety outcomes .


Amrubicin did not improve survival when compared with topotecan in the second-line treatment of patients with SCLC .


OS did not differ significantly between treatment groups , although an improvement in OS was noted in patients with refractory disease treated with amrubicin .


Essential hypertension is frequently associated with hyperuricemia in both adult and pediatric patients .


Lowering serum uric acid level may provide greater benefit than simply treating hypertension .


Forty-four adolescents , aged @-@years , newly diagnosed as essential hypertension ( secondary hypertension was excluded ) and previously untreated were randomized ( open label trial ) to receive either enalapril or enalapril plus allopurinol in combination .


All participants had baseline serum uric acid level @ mg/dl .


Baseline mean blood pressure ( BP ) , age and body mass index were similar between the two groups .


After @weeks ' treatment , BP reduction was greater , percent of treatment group achieving target BP level was greater , and serum uric acid level was lower in the combination treatment group .


There were no adverse effects during the course of therapy .


Results suggest that uric acid reduction may be used as adjunctive antihypertensive therapy in hypertensive adolescents with hyperuricemia while closely monitoring for any adverse effect .


To investigate the effect of rhubarb combined with early enteral nutrition ( EEN ) on the gastrointestinal function , disease severity and systemic inflammation in patients with severe acute pancreatitis ( SAP ) .


A total of @ patients with SAP were randomly assigned into three groups : parenteral nutrition group , treated with standard solution first and EN @ days later ; EEN group , treated with EN suspension ; or EEN combined with rhubarb group , treated with rhubarb and then EN @ h later .


The gastrointestinal function , APACHE II scores , the levels of plasma IL-@ , IL-@ , C-reactive proteins ( CRP ) and the liver and kidney functional measures were longitudinally analyzed .


Patients in the EEN/rhubarb group had the shortest period of abdominal pain and the fastest recovery from abnormal bowel movement and high fever as well as significantly shorter periods of intensive-care unit and hospital stays .


The combination of EEN and rhubarb significantly reduced the values of APACHE II scores .


Combination therapies significantly reduced abnormally higher white blood cell ( WBC ) counts and levels of plasma CRP and IL-@ , but increased the levels of plasma IL-@ .


Finally , combination therapies improved the SAP-related damages of liver and kidney function by reducing abnormally higher levels of plasma alanine aminotransferase , aspartate aminotransferase , and creatinine ( Cr ) .


Combination of EEN and rhubarb significantly improved the gastrointestinal function , inhibited systemic inflammation and disease severity and mitigated the disease-related damages of liver and kidney function in SAP patients .


Postoperative pain control constitutes a major problem and studies have focused on reducing opioid requirements using regional techniques .


We aimed to investigate the efficacy of wound infiltration with lornoxicam on postoperative pain control following thyroidectomy .


In this prospective , randomized-controlled study , @ patients scheduled for thyroidectomy were randomly assigned to @ groups .


After the thyroidectomy was performed , patients in group I underwent wound infiltration with @ mg of lornoxicam and patients in group II received the same amount of saline .


Rescue analgesia was provided with additional doses oflornoxicam delivered by an on-demand patient-controlled analgesia device .


Total analgesic consumption during the postoperative @ h , and pain intensities assessed using a visual analog scale score at @ , @ , @ , @ , @ and @ h postoperatively were recorded .


Pain scores during the postoperative @ h were slightly lower in group I than in group II , but the difference was not significant ( P > @ ) .


The mean analgesic consumption was @ @ mg and @ @ mg in groups I and II , respectively ( P > @ ) .


Wound infiltration with lornoxicam neither improved postoperative pain control nor decreased total analgesic consumption .


The objective of this study was to determine the effect of inspiratory resistance through an impedance threshold device ( ITD ) on orthostatic tolerance in patients with postural tachycardia syndrome .


We hypothesized that the ITD would result in a greater negative intrathoracic pressure to enhance cardiac venous return , improve stroke volume , and reduce heart rate in these patients .


We compared the effect of a sham device ( sham , no resistance ) versus an ITD ( increased inspiratory resistance ) in @ patients with postural tachycardia syndrome in a randomized , single-blind , crossover study .


Hemodynamic assessments were performed at baseline while supine and during head-up tilt to @ for @ minutes .


We did not find differences in baseline hemodynamic parameters between the ITD and the sham devices .


After @ minutes of head-up tilt , the heart rate was lower with the ITD versus sham device ( @ versus @ beat/min , respectively ; P = @ ) .


The ITD also improved stroke volume compared with the sham device ( @ versus @ mL ; P = @ ) .


These findings suggest that increasing negative intrathoracic pressure with ITD breathing improves heart rate control in patients with postural tachycardia syndrome during upright posture .


This prospective , randomized , single-centre study compared peginterferons alfa-@a and alfa-@b , combined with ribavirin , in treating patients infected with hepatitis C virus ( HCV ) genotype @ .


Hundred-and-one patients received @ weeks of open-label treatment with peginterferon alfa-@a ( @ g/week ) and @ patients received peginterferon alfa-@b ( @ g/kg/week ) .


All patients received the same dose of ribavirin @/@ mg/day , depending on weight .


The primary efficacy endpoint was sustained virologic response ( SVR ) , defined as undetectable HCV RNA ( < @ IU/mL ) @ weeks after the end of treatment .


Early virologic response ( EVR ) , defined as at least @ log IU/mL reduction of viral load at @ weeks , was more common in patients treated with peginterferon alfa-@a ( @ % vs. @ % ; p = @ ) .


However , the difference in SVR was not statistically significant ( @ % vs. @ % ; p = @ ) .


Peginterferon alfa-@a treated patients were also more likely to be HCV RNA negative at the end of treatment ( @ % vs. @ % ) , but this difference did not reach statistical significance .


Multivariate logistic regression analysis found that SVR was associated with low fibrosis stage ( F@-@ by Scheuer ; p = @ ) and low serum HCV RNA level ( < @,@ IU/L ; p = @ ) .


While both forms of peginterferon showed similar efficacy as measured by SVR , use of peginterferon alfa-@b could lower the number of patients receiving unnecessary treatment beyond @ weeks .


Trigger digit is one of the most common causes of pain and disability in the hand .


The mainstay of conservative treatment of this disease has been local steroid injection into the tendon sheath .


The aim of this study was to investigate the clinical benefit of an ultrasound-guided corticosteroid injection compared to a blinded application .


@ patients , who suffered from persistent or increasing symptoms of a single trigger digit , were enroled in this prospective , randomised case-control study .


All patients were treated with an injection of @ mg/@ ml methylprednisolone acetate into the flexor tendon sheath at the level of the A@ pulley .


Half of the patients had their injections under ultrasound control ( USG ) and half without ( blinded injection group , BIG ) .


Associated metabolic diseases were recorded .


At the @-week and @-month follow-up examinations , the complication rate and the need for a second injection were assessed .


The outcome was rated using the Quinnell grading .


The pain level was assessed using the visual analogue scale .


Four patients were excluded due to lack of follow-up .


Both study groups were comparable in respect of age , hand dominance and associated diseases .


There were significantly more female patients in the USG group ( @ versus @ % ) .


After the corticosteroid injections , all patients improved significantly in terms of pain level and the Quinnell grading at @ weeks and @ months after the intervention in comparison to the pre-injection status .


There were no significant differences between the groups .


@ patients ( @ % ) needed a second injection ( @ of BIG , @ of USG ) , all of whom had diabetes mellitus .


No local complications were seen after the injections .


The use of ultrasound-guided injection of corticosteroid may be associated with extra time and effort , with no superior clinical benefits compared to the blinded technique .


Level @ ( prospective randomised study ) .


To assess changes in Ocular Response Analyzer ( ORA ) waveforms after UVA/riboflavin corneal collagen cross-linking ( CXL ) using investigator-derived and manufacturer-supplied morphometric variables in patients with keratoconus ( KC ) and postrefractive surgery ectasia .


Prospective randomized trial of a standard epithelium-off CXL protocol .


Patients with progressive KC ( @ eyes of @ patients ) or postrefractive surgery ectasia ( @ eyes of @ patients ) were enrolled .


Replicate ORA measurements were obtained before and @ months after CXL .


Pretreatment and posttreatment waveform variables were analyzed for differences by paired Student t tests using measurements with the highest waveform scores .


Corneal hysteresis , corneal resistance factor , @-s generation manufacturer-supplied ORA variables , and @ investigator-derived ORA variables .


No variables were significantly different @ months after CXL in the KC group , and no manufacturer-supplied variables changed significantly in the postrefractive surgery ectasia group .


Four custom variables ( ApplanationOnsetTime , P@P@avg , Impulse , and Pmax ) increased by small but statistically significant margins after CXL in the postrefractive surgery ectasia group .


Changes in a small subset of investigator-derived variables suggested an increase in corneal bending resistance after CXL .


However , the magnitudes of these changes were low and not commensurate with the degree of clinical improvement or prior computational estimates of corneal stiffening in the same cohort over the same period .


Available air-puff-derived measures of the corneal deformation response underestimate the biomechanical changes produced by CXL .


Denosumab @ mg sc injection every @ months for @ months was well tolerated and effective in reducing the incidence of vertebral , nonvertebral , and hip fracture in predominantly Caucasian postmenopausal women with osteoporosis .


The objective of this phase @ fracture study was to examine the antifracture efficacy and safety of denosumab @ mg in Japanese women and men with osteoporosis compared with placebo .


A randomized , double-blind , placebo-controlled trial with an open-label active comparator as a referential arm was conducted .


Subjects were @ Japanese patients with osteoporosis aged @ years or older , who had one to four prevalent vertebral fractures .


Subjects were randomly assigned to receive denosumab @ mg sc every @ months ( n = @ ) , placebo for denosumab ( n = @ ) , or oral alendronate @ mg weekly ( n = @ ) .


All subjects received daily supplements of calcium and vitamin D.


The primary endpoint was the @-month incidence of new or worsening vertebral fracture for denosumab vs placebo .


Denosumab significantly reduced the risk of new or worsening vertebral fracture by @ % , with incidences of @ % in denosumab and @ % in placebo at @ months ( hazard ratio @ ; @ % confidence interval @-@ @ , P = @ ) .


No apparent difference in adverse events was found between denosumab and placebo during the first @ months of the study .


These results provide evidence of the efficacy and safety of denosumab @ mg sc every @ months in Japanese subjects with osteoporosis .


To determine whether inoculation of healthy dogs with a recombinant peptide containing @ copies of ACTH would result in the production of antibodies against ACTH and whether this would affect pituitary-adrenocortical function .


@ healthy dogs .


A recombinant peptide consisting of @ copies of ACTH fused to a T-helper cell epitope was produced in Escherichia coli .


The protein was inoculated into @ dogs at @-week intervals ( total of @ inoculations/dog ) .


Four control dogs received inoculations of PBS solution mixed with adjuvant .


Blood samples were collected for determination of antibody titers against ACTH and for measurement of basal and ACTH-stimulated plasma cortisol concentrations .


Inoculation with the ACTH vaccine resulted in production of anti-ACTH antibodies in all @ dogs .


Titers were initially high but declined by @ weeks after the initial inoculation .


Basal cortisol concentrations were unaffected by inoculation with the ACTH vaccine .


Plasma cortisol concentrations in response to ACTH stimulation were reduced at @ weeks , but not at @ weeks , after the first inoculation .


Inoculation of dogs with a recombinant ACTH vaccine resulted in the production of antibodies against the hormone .


Anti-ACTH titers were initially high but were not sustained .


The only detectable endocrine effect in treated dogs was a reduction in cortisol concentration in response to ACTH stimulation in @ of @ dogs at @ weeks after the first inoculation .


The effect of vaccine administration on the pituitary-adrenal system was subtle and transient .


Many patients on maintenance dialysis experience significant sleepiness and fatigue .


However , the influence of the hemodialysis ( HD ) day and circadian rhythms on patients ' symptoms have not been well characterized .


We sought to use ecological momentary assessment to evaluate day-to-day and diurnal variability of fatigue , sleepiness , exhaustion and related symptoms in thrice-weekly maintenance HD patients .


Subjects used a modified cellular phone to access an interactive voice response system that administered the Daytime Insomnia Symptom Scale ( DISS ) .


The DISS assessed subjective vitality , mood , and alertness through @ questions using @ - point Likert scales .


Subjects completed the DISS @ times daily for @ consecutive days .


Factor analysis was conducted and a mean composite score of fatigue-sleepiness-exhaustion was created .


Linear mixed regression models ( LMM ) were used to examine the association of time of day , dialysis day and fatigue , sleepiness , and exhaustion composite scores .


The @ participants completed @,@ of @,@ ( @ % ) possible assessments over the @ day period .


Multiple symptoms related to mood ( e.g. , feeling sad , feeling tense ) , cognition ( e.g. , difficulty concentrating ) , and fatigue ( e.g. , exhaustion , feeling sleepy ) demonstrated significant daily and diurnal variation , with higher overall symptom scores noted on hemodialysis days and later in the day .


In factor analysis , @ factors explained the majority of the observed variance for DISS symptoms .


Fatigue , sleepiness , and exhaustion loaded onto the same factor and were highly intercorrelated .


In LMM , mean composite fatigue-sleepiness-exhaustion scores were associated with dialysis day ( coefficient and @ % confidence interval -LSB- CI -RSB- @ -LSB- @ - @ -RSB- ) and time of day ( coefficient and @ % CI @ -LSB- @ - @ -RSB- .


Observed associations were minimally affected by adjustment for demographics and common confounders .


Maintenance HD patients experience fatigue-sleepiness-exhaustion symptoms that demonstrate significant daily and diurnal variation .


The variability in symptoms may contribute to poor symptom awareness by providers and greater misclassification bias of fatigue related symptoms in clinical studies .


Endometrial adenocarcinoma ( EC ) is the most common gynaecologic cancer .


Up to @ % of EC patients are obese which poses a health threat to patients post-treatment .


Standard treatment for EC includes hysterectomy , although this has significant side effects for obese women at high risk of surgical complications and for women of childbearing age .


This trial investigates the effectiveness of non-surgical or conservative treatment options for obese women with early stage EC .


The primary aim is to determine the efficacy of : levonorgestrel intrauterine device ( LNG-IUD ) ; with or without metformin ( an antidiabetic drug ) ; and with or without a weight loss intervention to achieve a pathological complete response ( pCR ) in EC at six months from study treatment initiation .


The secondary aim is to enhance understanding of the molecular processes and to predict a treatment response by investigating EC biomarkers .


An open label , three-armed , randomised , phase-II , multi-centre trial of LNG-IUD metformin weight loss intervention .


@ participants from @ centres are randomly assigned in a @:@:@ ratio to the treatment arms .


Clinical , quality of life and health behavioural data will be collected at baseline , six weeks , three and six months .


EC biomarkers will be assessed at baseline , three and six months .


There is limited prospective evidence for conservative treatment for EC .


Trial results could benefit patients and reduce health system costs through a reduction in hospitalisations and through lower incidence of adverse events currently observed with standard treatment .


To compare the cost-effectiveness of three types of follow-up for outpatients with stable low-activity rheumatoid arthritis ( RA ) .


In total , @ patients were randomized to either planned rheumatologist consultations , shared care without planned consultations , or planned nurse consultations .


Effectiveness measures included disease activity ( Disease Activity Score based on @ joint counts and C-reactive protein , DAS@-CRP ) , functional status ( Health Assessment Questionnaire , HAQ ) , and health-related quality of life ( EuroQol EQ-@D ) .


Cost measures included activities in outpatient clinics and general practice , prescription and non-prescription medicine , dietary supplements , other health-care resources , and complementary and alternative care .


Measures of effectiveness and costs were collected by self-reported questionnaires at inclusion and after @ and @ months .


Incremental cost-effectiveness rates ( ICERs ) were estimated in comparison with rheumatologist consultations .


Changes in disease activity , functional status , and health-related quality of life were not statistically significantly different for the three groups , although the mean scores were better for the shared care and nurse care groups compared with the rheumatologist group .


Shared care and nurse care were non-significantly less costly than rheumatologist care .


As both shared care and nurse care were associated with slightly better EQ-@D improvements and lower costs , they dominated rheumatologist care .


At EUR @,@ per quality-adjusted life year ( QALY ) threshold , shared care and nurse care were cost-effective with more than @ % probability .


Nurse care was cost-effective in comparison with shared care with @ % probability .


Shared care and nurse care seem to cost less but provide broadly similar health outcomes compared with rheumatologist outpatient care .


However , it is still uncertain whether nurse care and shared care are cost-effective in comparison with rheumatologist outpatient care .


Methotrexate is a commonly used anti-inflammatory and immunosuppressive drug .


There is growing evidence that inflammatory processes are involved in the pathogenesis of schizophrenia .


In our recent randomised double-blind placebo-controlled clinical trial in Pakistan and Brazil , the addition of minocycline ( antibiotic and anti-inflammatory drug ) for @year to treatment as usual reduced negative symptoms and improved some cognitive measures .


A meta-analysis of cytokine changes in the peripheral blood has identified IL-@ , IFN-gamma , TNF-alpha and soluble IL-@ receptor as trait markers of schizophrenia because their levels were elevated during acute exacerbations and reduced in remission .


This suggests immune activation and an inflammatory syndrome in schizophrenia .


Based on the evidence of the strong anti-inflammatory properties of methotrexate , we propose that low-dose methotrexate may be an effective therapy in early schizophrenia .


This is a double-blind placebo-controlled study of methotrexate added to treatment as usual for patients suffering from schizophrenia , schizoaffective disorder , psychosis not otherwise specified or schizophreniform disorder .


This will be with @ patients , @ in each arm over @months .


There will be screening , randomisation and follow-up visits .


Full clinical assessments will be carried out at baseline , @ , @ , @ and @weeks .


Social and cognitive assessments will be carried out at baseline and @weeks .


Methotrexate will be given at a dose of @ mgs orally once a week for a @-month period .


Evidence suggests inflammatory processes are involved in the pathogenesis of schizophrenia and anti-inflammatory treatments have shown to have some beneficial effects .


Methotrexate is a known immunosuppressant and anti-inflammatory drug .


The aim of this study is to establish the degree of improvement in positive and negative symptoms , as well as cognitive functioning with the addition of methotrexate to treatment as usual.ClinicalTrials.gov identifier : NCT@ ( @ February @ ) .


The role of bony pelvic anomalies in bladder exstrophy is long established and has generated many papers addressing walking problems .


Biomechanical studies and kinematic gait analysis were performed on very young children .


A direct kinetic gait evaluation has never been performed , nor has the effect of pelvis dimorphism on the upper body been studied .


Controlled experimental study .


Outpatients were studied at the time of periodic follow up .


Nineteen patients with bladder exstrophy , age @ years , and twenty-five healthy control participants , age @ years , were enrolled in the present gait analysis study .


Clinical evaluation and standard gait analysis were performed .


Gait analysis deviations between exstrophy patients and controls and between patients that received pelvic osteotomy ( OT -- @ patients ) and those that did not ( no-OT -- @ patients ) were analyzed .


Bladder exstrophy significantly affects kinematics and kinetics of trunk , spine , pelvis , knee and foot ; in particular : in OT , trunk retroversion , pelvic retroversion and rotation , hip adduction angle and moment , knee flexion and its maximum power during loading response increased , whereas in no-OT , spine angle , pelvic posterior tilt , hip extension , and the external rotation of the foot progression angle increased .


All the kinetics parameters analyzed in the study showed lower values in the patient group than in controls .


Walking in patients with bladder exstrophy is accomplished by retroversion of the pelvis and deviations mainly in the spine angle in no-OT and in knee flexion in OT .


Gait analysis was shown to be an effective tool for the detection of walking deviations that should be identified early , prompting rehabilitative treatment in order to prevent spine and knee diseases .


Maladaptive behaviors may be more fully understood and efficiently prevented by ambulatory tools that assess people 's ongoing experience in the context of their environment .


To demonstrate new field-deployable methods for assessing mood and behavior as a function of neighborhood surroundings ( geographical momentary assessment ; GMA ) , we collected time-stamped GPS data and ecological momentary assessment ( EMA ) ratings of mood , stress , and drug craving over @ weeks at randomly prompted times during the waking hours of opioid-dependent polydrug users receiving methadone maintenance .


Locations of EMA entries and participants ' travel tracks calculated for the @ before each EMA entry were mapped .


Associations between subjective ratings and objective environmental ratings were evaluated at the whole neighborhood and @-h track levels .


Participants ( N = @ ) were compliant with GMA data collection ; @ randomly prompted EMA entries were matched to specific locations .


At the neighborhood level , physical disorder was negatively correlated with negative mood , stress , and heroin and cocaine craving ( ps < @ -@ ) ; drug activity was negatively correlated with stress , heroin and cocaine craving ( ps @ -@ ) .


Similar relationships were found for the environments around respondents ' tracks in the @h preceding EMA entries .


The results support the feasibility of GMA .


The relationships between neighborhood characteristics and participants ' reports were counterintuitive and counter-hypothesized , and challenge some assumptions about how ostensibly stressful environments are associated with lived experience and how such environments ultimately impair health .


GMA methodology may have applications for development of individual - or neighborhood-level interventions .


In single-incision laparoscopic surgery ( SILS ) , operating through @ incision presents ergonomic challenges .


No consensus exists on whether articulating instruments ( ARTs ) may help .


This study evaluated their effect on simulated SILS , hypothesizing that they would affect performance and workload .


Surgeons were randomized to @ straight instruments ( STRs ) , @ ART and @ STR , or @ ARTs .


After baseline testing , @ repetitions of the Fundamentals of Laparoscopic Surgery ( FLS ) peg-transfer ( PEG ) task and @ repetitions of the short-hand for the FLS pattern-cutting task ( CIRCLE ) were performed .


Primary outcomes were maximum FLS PEG scores , CIRCLE times and errors , and Imperial College Surgical Assessment Device hand motion analysis .


National Aeronautics and Space Administration ( NASA ) Raw Task Load Index ( RTLX ) questionnaires evaluated a secondary outcome -- workload .


The trial took place in a simulated operating theater within the Academic Surgical Unit at St Mary 's Hospital , London , UK .


Eligible surgeons had completed at least @ laparoscopic cases as a primary operator .


Surgeons were stratified by laparoscopic experience into intermediate ( less than @ previous procedures as primary operator ) or advanced ( @ procedures or more ) .


A total of @ surgeons were recruited and randomized ; @ of them to each instrument combination group .


All surgeons completed PEG , and @ from each group completed CIRCLE .


Groups ' baseline PEG scores were similar ( p = @ ) .


STR-ART achieved higher maximum PEG scores than STR or ART did ( median = @ vs @ vs @ , respectively , p = @ ) .


Fastest CIRCLE times were similar ( median = @s vs @s vs @s , p = @ ) as were minimum errors ( median = @ vs @ vs @ , p = @ ) .


For PEG , Imperial College Surgical Assessment Device demonstrated similar total path lengths ( median = @ m vs @ m vs @ m , p = @ ) and total numbers of movements ( median = @ vs @ vs @ , p = @ ) .


Groups ' NASA Raw Task Load Index scores were similar ( p = @ ) .


Combining @ STR and @ ART improved SILS performance in the PEG task .


Therefore , this may be the optimum instrument configuration for use within some clinical SILS applications .


We evaluated the effectiveness of a continuing medical education program , Physician Asthma Care Education , in improving pediatricians ' asthma therapeutic and communication skills and patients ' health care utilization for asthma .


We conducted a randomized trial in @ regions in the United States .


Primary care providers were recruited and randomly assigned by site to receive the program provided by local faculty .


The program included @ interactive seminar sessions ( @ hours each ) that reviewed national asthma guidelines , communication skills , and key educational messages .


Format included short lectures , case discussions , and a video modeling communication techniques .


We collected information on parent perceptions of physicians ' communication , the child 's asthma symptoms , and patients ' asthma health care utilization .


We used multivariate regression models to determine differences between control and intervention groups .


A total of @ primary care providers and a random sample of @ of their asthma patients participated .


After @ year , we completed follow-up telephone interviews with the parents of @ of the @ patients .


Compared to control subjects , parents reported that physicians in the intervention group were more likely to inquire about patients ' concerns about asthma , encourage patients to be physically active , and set goals for successful treatment .


Patients of physicians that attended the program had a greater decrease in days limited by asthma symptoms ( @ vs @ days ) , as well as decreased emergency department asthma visits ( @ vs @ visits per year ) .


The Physician Asthma Care Education program was used in a range of locations and was effective in improving parent-reported provider communication skills , the number of days affected by asthma symptoms , and asthma health care use .


Patients with more frequent asthma symptoms and higher health care utilization at baseline were more likely to benefit from their physician 's participation in the program .


There are few rigorous studies to confirm or refute the commonly cited concern that control of blood pressure to lower thresholds may result in an increased risk of falls and fractures .


To compare falls and fractures in participants with type @ diabetes in the intensive ( targeting a systolic blood pressure of < @ mmHg ) and standard ( targeting a systolic blood pressure of < @ mmHg ) blood pressure control arms of the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) randomized trial ( N = @,@ ) .


A subset of @,@ participants self-reported annually on the occurrence of falls and non-spine fractures .


Fractures were centrally adjudicated .


The incidence of falls in the two treatment groups was compared using a random-effects negative binomial model , and fracture risk was compared using Cox proportional hazards models .


At enrollment in both groups , the mean age was @ years , @ % were women , @ % were Black , and mean blood pressure was @/@ mmHg .


During follow-up , all classes of medications , particularly thiazide diuretics , were more commonly prescribed in the intensive group .


After @ year of follow-up , the mean systolic blood pressure was @ mmHg in the standard group and @ mmHg in the intensive group .


The adjusted rate of falls did not differ in the intensive and standard groups ( @ / @ person-years vs. @ / @ person-years , RR = @ , @ % CI @-@ @ , p = @ ) .


The risk of non-spine fractures was nonsignificantly lower in the intensive than in the standard blood pressure group ( HR @ , @ % CI @-@ @ , p = @ ) .


We conclude that intensive antihypertensive treatment that lowered mean systolic blood pressure to below @ mmHg was not associated with an increased risk of falls or non-spine fractures in patients age @ to @ years with type @ diabetes .


Thromboembolism is the most common complication in coiling for an unruptured aneurysm and is frequent in patients with high on-treatment platelet reactivity ( HTPR ) who are prescribed a standard antiplatelet preparation for its prevention .


To evaluate the effect of a modified antiplatelet preparation compared with a standard preparation in patients with HTPR undergoing coiling .


A prospective randomized open-label active-control trial with blinded outcome assessment at the Seoul National University Bundang Hospital from May @ , @ , to April @ , @ .


Patients with HTPR were randomly assigned ( @ to @ ) to the standard or modified preparation group .


Patients without HTPR were assigned to the non-HTPR group .


A total of @ patients undergoing coiling for unruptured aneurysms were enrolled and allocated to the study , @ in the HTPR group ( @ to the standard preparation group and @ to the modified preparation group ) and @ to the non-HTPR group .


Intent-to-treat analysis was performed .


The modified preparation ( HTPR to aspirin , @ mg of aspirin and @ mg of clopidogrel bisulfate ; and HTPR to clopidogrel , @ mg of cilostazol added to the standard regimen ) was performed before coiling in the modified preparation group .


Standard preparation ( @ mg of aspirin and @ mg of clopidogrel ) was maintained in the standard preparation and non-HTPR groups .


The primary outcome was a thromboembolic event defined as thromboembolism during coiling and a transient ischemic attack or ischemic stroke within @ days after coiling .


The principal secondary outcome was a bleeding complication according to Thrombolysis in Myocardial Infarction bleeding criteria within @ days after coil embolization .


The thromboembolic event rate was low in the modified preparation group ( @ of @ -LSB- @ % -RSB- ) compared with the standard preparation group ( @ of @ -LSB- @ % -RSB- ; adjusted risk difference , -@ % -LSB- @ % CI , -@ % to -@ % -RSB- ; P = @ ) , which had a higher thromboembolic risk than the non-HTPR group ( @ of @ -LSB- @ % -RSB- ; adjusted risk difference , @ % -LSB- @ % CI , @ % to @ % -RSB- ; P = @ ) .


All bleeding complications were of minimal grade according to Thrombolysis in Myocardial Infarction bleeding criteria .


The bleeding rate was not different between the modified ( @ of @ -LSB- @ % -RSB- ) and standard ( @ of @ -LSB- @ % -RSB- ) preparation groups ( adjusted risk difference , @ % -LSB- @ % CI , -@ % to @ % -RSB- ; P = @ ) .


Modified antiplatelet preparation for patients with HTPR compared with standard antiplatelet preparation reduced the thromboembolic event rate in coiling for an unruptured aneurysm without increasing bleeding .


Minority patients with breast cancer are at risk for undertreatment of cancer-related pain .


The authors evaluated the feasibility and efficacy of an automated pain intervention for improving pain and symptom management of underserved African American and Latina women with breast cancer .


Sixty low-income African American and Latina women with breast cancer and cancer-related pain were enrolled in a pilot study of an automated , telephone-based , interactive voice response ( IVR ) intervention .


Women in the intervention group were called twice weekly by the IVR system and asked to rate the intensity of their pain and other symptoms .


The patients ' oncologists received e-mail alerts if the reported symptoms were moderate to severe .


The patients also reported barriers to pain management and received education regarding any reported obstacles .


The proportion of women in both groups reporting moderate to severe pain decreased during the study , but the decrease was significantly greater for the intervention group .


The IVR intervention also was associated with improvements in other cancer-related symptoms , including sleep disturbance and drowsiness .


Although patient adherence to the IVR call schedule was good , the oncologists who were treating the patients rated the intervention as only somewhat useful for improving symptom management .


The IVR intervention reduced pain and symptom severity for underserved minority women with breast cancer .


Additional research on technological approaches to symptom management is needed .


To evaluate the effect of an improved salt-restriction spoon on the attitude of salt-restriction , the using rate of salt-restriction-spoon , the actual salt intake , and @-hour urinary sodium excretion ( @HUNa ) .


A community intervention study .


Two villages in Beijing .


@ local adult residents being responsible for home cooking .


Participants were randomly assigned to the intervention group or the control group .


Those in the intervention group were provided with an improved salt-restriction-spoon and health education , and were informed of their actual salt intake and @HUNa .


Not any intervention was given to those in the control group .


The scores on the variables of Health Belief Model , the using rate of salt-restriction-spoon , the actual salt intake , and @HUNa .


Covariance analyses , Chi-square tests , Student 's t tests , and repeated measures analyses of variance .


After @ months of intervention , the intervention group felt significantly less objective barriers , and got access to significantly more cues to action as compared to the control group .


The using rate and the correctly using rate of salt-restriction-spoon were significantly higher in the intervention group .


The daily salt intake decreased by @ g in the intervention group and by @ g in the control group , and repeated measures analysis of variance showed significant change over time ( F = @ , P < @ ) and significant difference between groups by time ( F = @ , P = @ ) .


The @HUNa decreased by @ mmol in the intervention group and by @ mmol in the control group , and repeated measures analysis of variance showed significant change over time ( F = @ , P < @ ) without significant difference between groups by time ( F = @ , P = @ ) .


The intervention effect was acceptable , therefore , the improved salt-restriction-spoon and corresponding health education could be considered as an alternative for salt reduction strategy in China and other countries where salt intake comes mainly from home cooking .


Revisional laparoscopic surgery after Roux-en-Y gastric bypass ( RYGB ) has been linked to substantial complications and morbidity .


To investigate the safety and effectiveness of endoscopic gastric plication with the StomaphyX device vs a sham procedure for revisional surgery in RYGB patients to reduce regained weight .


A prospective , single-center , randomized , single-blinded study from July @ through February @ , evaluating revisional surgery using StomaphyX was conducted in patients with initial weight loss after RYGB performed at least @ years earlier .


We planned for @ patients to be randomized @:@ to multiple full-thickness plications within the gastric pouch and stoma using the StomaphyX device with SerosFuse fasteners or a sham endoscopic procedure and followed up for @ year .


The primary efficacy end point was reduction in pre-RYGB excess weight by @ % or more excess body mass index ( BMI ) ( calculated as weight in kilograms divided by height in meters squared ) loss and BMI less than @ at @ months after the procedure .


Adverse events were recorded .


Enrollment was closed prematurely because preliminary results indicated failure to achieve the primary efficacy end point in at least @ % of StomaphyX-treated patients .


One-year follow-up was completed by @ patients treated with StomaphyX and @ patients in the sham treatment group .


Primary efficacy outcome was achieved by @ % ( @ ) with StomaphyX vs @ % ( @ ) with the sham procedure ( P < @ ) .


Patients undergoing StomaphyX treatment experienced significantly greater reduction in weight and BMI at @ , @ , and @ months ( P. @ ) .


There was one causally related adverse event with StomaphyX , that required laparoscopic exploration and repair .


StomaphyX treatment failed to achieve the primary efficacy target and resulted in early termination of the study .


Carpal tunnel syndrome is traditionally treated with open release through a long palmar incision , which leaves some patients with pillar pain and scar tenderness .


The Knifelight ( Stryker , Kalamazoo , MI ) is an exciting new instrument that allows minimally invasive release of the transcarpal ligament without subjecting the patient to the traditional problematic open palmar incision .


However , no long-term data has been published in the literature so far .


A modified QuickDASH score questionnaire was used to assess long-term results and patient satisfaction @ years following our department 's original randomized control trial comparing open carpal tunnel release ( @ patients ) to carpal tunnel release using the Knifelight method ( @ patients ) .


The mean modified QuickDASH score was @ ( SD @ ) for the open group and @ ( SD @ ) for the Knifelight group ( P-value = @ ) .


Patients from the open group complained of pillar pain ( @ % ) , scar tenderness ( @ % ) and recurrence of carpal tunnel symptoms ( @ % ) .


Three patients had symptoms so severe that they could not perform their jobs .


In the Knifelight group there were no reports of any pain , recurrence or scar-related problems and a high level of general satisfaction was observed with this group of patients .


Our study results show that the minimally invasive Knifelight carpal tunnel release was associated with better clinical outcomes , less complications and overall better quality of life when compared to the conventional open carpal tunnel release .


Calcitriol is used to treat secondary hyperparathyroidism in patients with CKD .


Paricalcitol is less calcemic and phosphatemic in preclinical studies and in some trials in dialysis patients , but head-to-head comparisons in nondialysis patients are lacking .


A large meta-analysis of trials concluded that these agents did not consistently reduce parathyroid hormone ( PTH ) and increased the risk of hypercalcemia and hyperphosphatemia .


Therefore , the objective of this multicenter trial was to compare the rate of hypercalcemia between calcitriol and paricalcitol , while suppressing PTH @ % -@ % .


Patients with stages @-@ CKD ( n = @ ) with a PTH level > @ pg/ml were recruited and randomized to @ g/d of calcitriol or @ g/d of paricalcitol between April @ and July @ .


Subsequent dose adjustments were by protocol to achieve @ % -@ % PTH suppression below baseline .


The primary endpoint was the rate of confirmed hypercalcemia of > @ mg/dl between groups .


Forty-five patients in each group completed the @ weeks of treatment .


Both agents suppressed PTH effectively ( -@ % with paricalcitol and -@ % with calcitriol ; P = @ ) , although the paricalcitol group reached a @ % reduction in PTH sooner at a median @ weeks ( interquartile range -LSB- IQR -RSB- , @ , @ ) versus @ weeks ( IQR , @ , @ ; P = @ ) and had a lower pill burden of @ ( IQR , @ , @ ) versus @ ( IQR , @ , @ ; P = @ ) .


Confirmed hypercalcemia was very low in both groups ( three with paricalcitol and one with calcitriol ) and was not significantly different ( P = @ ) .


Both groups had small increases in calcium and phosphorus levels ( @-@ @ mg/dl in each electrolyte ) and significant decreases in alkaline phosphatase , a marker of high bone turnover , with no significant differences between groups .


These results show that both calcitriol and paricalcitol achieved sustained PTH and alkaline phosphatase suppression in stages @-@ CKD , with small effects on serum calcium and phosphorus and a low incidence of hypercalcemia .


Both testosterone therapy and chronic treatment with phosphodiesterase type @ inhibitors ( PDE@Is ) have positive effects on the histology of penile corpora and erectile function .


However , few clinical studies have evaluated the efficacy of combination therapy with both testosterone replacement and chronic PDE@Is .


This study was designed to evaluate the efficacy and safety of combination treatment with long-acting injectable testosterone undecanoate ( TU ) and a once-daily tadalafil @mg for erectile dysfunction with testosterone deficiency syndrome .


Sixty patients were consecutively enrolled and followed for @ weeks .


Thirty patients were randomly assigned to group I and received @,@ mg of parenteral TU on day @ , followed by additional injections at weeks @ and @ with on-demand tadalafil @-@mg during the @ weeks of treatment .


The remaining @ patients received the same dose and schedule of TU as group I , and were prescribed once-daily tadalafil @mg during @ weeks .


Serological tests were performed , and the International Index of Erectile Function ( IIEF ) , Aging Males ' Symptoms ( AMS ) questionnaires , and Global Assessment Question ( GAQ ) were administered to the patients .


Total IIEF and AMS scores were significantly improved during the @ weeks of treatment in both groups .


When IIEF scores were compared between the two groups , group II showed better symptom scores than group I at weeks @ and @ .


A similar pattern was observed when comparing AMS scores between the groups .


At week @ , changes in IIEF and AMS scores that indicated worsened symptoms compared with week @ were observed in both groups ; group II showed better symptom scores than group I. On the GAQ , the ratio of patients reporting improvement in erectile function was significantly higher in group II than group I.


The combination of long-acting injectable TU and once-daily tadalafil @mg produced a significant improvement in erectile function .


Moreover , the improvement in erectile function was well maintained , even after the cessation of treatment .


To determine the effects of pretreatment with either promethazine or dexamethasone on mivacurium-induced histamine release in children .


Eighty ASA I-II children ( @-@years of age ) scheduled for tonsillectomy and/or adenoidectomy were randomly divided into @ groups ( n = @ per group ) designated as either the rocuronium , mivacurium , dexamethasone ( DXM ) , or promethazine group .


Children in the DXM and promethazine groups were treated separately with intramuscular DXM @ mgkg ( -@ ) or promethazine @ mgkg ( -@ ) injections @min before operation .


Radial artery blood samples were collected to quantify plasma histamine concentrations @min before and @ , @ , and @min after administration of the relaxant .


Mean arterial pressure ( MAP ) , heart rate ( HR ) , and skin flushing were recorded at the same time .


No significant decreases in plasma histamine concentrations were observed between groups ; however , more stable MAP and HR and less skin flushing were observed in DXM group participants compared with individuals in the mivacurium group ( P < @ ) .


By contrast , children in the promethazine group had significantly decreased plasma histamine concentrations and stable MAP and HR ( without a significant increase in HR ) compared with patients in mivacurium group .


In addition , skin flushing was significantly decreased compared with that observed in the rocuronium group ( P < @ ) .


Pretreatment with promethazine significantly decreased mivacurium-induced histamine release in children and provided stable hemodynamics during administration of anesthesia .


Improved health outcomes can result in economic savings for hospitals and payers .


While effectiveness of topical hemostatic agents in cardiac surgery has been demonstrated , evaluations of their economic benefit are limited .


This study quantifies the cost consequences to hospitals , based on clinical outcomes , from using a flowable hemostatic matrix vs non-flowable topical hemostatic agents in cardiac surgery .


Applying clinical outcomes from a prospective randomized clinical trial , a cost consequence framework was utilized to model the economic impact of comparator groups .


From that study , clinical outcomes were obtained and analyzed for a flowable hemostatic matrix ( FLOSEAL , Baxter Healthcare Corporation ) vs non-flowable topical hemostats ( SURGICEL Nu-Knit , Ethicon-Johnson & Johnson ; GELFOAM , Pfizer ) .


Costing analyses focused on the following outcomes : complications , blood transfusions , surgical revisions , and operating room ( OR ) time .


Cardiac surgery costs were analyzed and expressed in @ US dollars based on available literature searches and US data .


Comparator group variability in cost consequences ( i.e. , cost savings ) was calculated based on annualized impact and scenario testing .


RESULTS suggest that if a flowable hemostatic matrix ( rather than a non-flowable hemostat ) was utilized exclusively in @ mixed cardiac surgeries annually , a hospital could improve patient outcomes by a reduction of @ major complications , @ minor complications , @ surgical revisions , @ transfusions , and @ h of OR time .


These outcomes correspond to a net annualized cost consequence savings of $ @ million , with complication avoidance as the largest contributor .


This cost consequence framework and supportive modeling was used to evaluate the hospital economic impact of outcomes resulting from the usage of various hemostatic agents .


These analyses support that cost savings can be achieved from routine use of a flowable hemostatic matrix , rather than a non-flowable topical hemostat , in cardiac surgery .


This report presents data from one of the first trials of apomorphine rescue treatment for advanced Parkinson 's disease ( PD ) conducted in Japan .


This @ month trial aimed to evaluate the sustainability of efficacy of intermittent apomorphine rescue treatment .


A phase III , double-blind , placebo-controlled trial was conducted in PD patients ( n = @ ) with motor fluctuations in spite of individually titrated treatment with levodopa and other anti PD .


Intermittent treatment was titrated to the maintenance dose with a subsequent unblind @-week outpatient phase .


At the week-@ visit , response to apomorphine or placebo was assessed as primary efficacy endpoint using the Unified Parkinson 's Disease Rating Scale ( UPDRS ) part III ( Motor Examination ) under double-blind crossover conditions .


In the crossover phase ( n = @ ) , least squares mean changes in the UPDRS part III score from pre-dose were -@ points with apomorphine and -@ points with placebo , showing that apomorphine , compared with placebo , provided a significantly greater improvement in the UPDRS part III score change ( difference between treatments : -@ -LSB- @ % confidence interval , -@ , -@ -RSB- ; P < @ ) .


The most frequently reported adverse events during the study were increased eosinophil count ( @ patients ) , nausea ( @ ) , somnolence ( @ ) , dyskinesia ( @ ) , yawning ( @ ) , and decreased blood pressure ( @ ) .


Our results indicate that a @-month use of intermittent apomorphine is an effective rescue therapy for `` off '' episodes in advanced PD patients .


To assess face , content and construct validity , and feasibility and acceptability of the GreenLight Simulator as a training tool for photoselective vaporisation of the prostate ( PVP ) , and to establish learning curves and develop an evidence-based training curriculum .


This prospective , observational and comparative study , recruited novice ( @ participants ) , intermediate ( @ ) and expert-level urologists ( seven ) from the UK and Europe at the @th European Association of Urological Surgeons Annual Meeting @ .


A group of novices ( @ participants ) performed @ sessions of subtask training modules followed by a long operative case , whereas a second group ( @ ) performed five sessions of a given case module .


Intermediate and expert groups performed all training modules once , followed by one operative case .


The outcome measures for learning curves and construct validity were time to task , coagulation time , vaporisation time , average sweep speed , average laser distance , blood loss , operative errors , and instrument cost .


Face and content validity , feasibility and acceptability were addressed through a quantitative survey .


Construct validity was demonstrated in two of five training modules ( P = @ ; P = @ ) and in a considerable number of case metrics ( P = @ ) .


Learning curves were seen in all five training modules ( P < @ ) and significant reduction in case operative time ( P < @ ) and error ( P = @ ) were seen .


An evidence-based training curriculum , to help trainees acquire transferable skills , was produced using the results .


This study has shown the GreenLight Simulator to be a valid and useful training tool for PVP .


It is hoped that by using the training curriculum for the GreenLight Simulator , novice trainees can acquire skills and knowledge to a predetermined level of proficiency .


Incidence of sexually transmitted infections ( STIs ) among young people in the United Kingdom is increasing .


The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion , given its high usage among young people , its potential for creating a sense of anonymity , and ease of access .


Online randomized controlled trials ( RCTs ) are increasingly being used to evaluate online interventions , but while there are many advantages to online methodologies , they can be associated with a number of problems , including poor engagement with online interventions , poor trial retention , and concerns about the validity of data collected through self-report online .


We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website .


This study reports on a qualitative evaluation of the trial procedures , describing participants ' experiences and views of the Sexunzipped online trial including methods of recruitment , incentives , methods of contact , and sexual health outcome measurement .


Our goal was to determine participants ' views of the acceptability and validity of the online trial methodology used in the pilot RCT of the Sexunzipped intervention .


We used three qualitative data sources to assess the acceptability and validity of the online pilot RCT methodology : ( @ ) individual interviews with @ participants from the pilot RCT , ( @ ) @ emails received by the trial coordinator from trial participants , and ( @ ) @ free-text comments from the baseline and follow-up questionnaires .


Interviews were audio-recorded and transcribed verbatim .


An iterative , thematic analysis of all three data sources was conducted to identify common themes related to the acceptability and feasibility of the online trial methodology .


Interview participants found the trial design , including online recruitment via Facebook , online registration , email communication with the researchers , and online completion of sexual health questionnaires to be highly acceptable and preferable to traditional methods .


Incentives might assist in recruiting those who would not otherwise participate .


Participants generally enjoyed taking part in sexual health research online and found the questionnaire itself thought-provoking .


Completing the sexual health questionnaires online encouraged honesty in responding that might not be achieved with other methods .


The majority of interview participants also thought that receiving and returning a urine sample for chlamydia testing via post was acceptable .


These findings provide strong support for the use of online research methods for sexual health research , emphasizing the importance of careful planning and execution of all trial procedures including recruitment , respondent validation , trial related communication , and methods to maximize follow-up .


Our findings suggest that sexual health outcome measurement might encourage reflection on current behavior , sometimes leading to behavior change .


In addition to lowering hemoglobin A@C , colesevelam has been shown to improve the atherogenic lipoprotein profile of subjects with type @ diabetes mellitus ( T@DM ) when used in combination with metformin and/or sulfonylureas .


A recent study evaluated the effects of colesevelam as antidiabetes monotherapy in adults with T@DM who had inadequate glycemic control ( hemoglobin A@C @ to @ % ) with diet and exercise alone ; we report here the effects on lipoprotein particle subclasses .


Subjects were randomized to receive oral colesevelam @ g/day ( n = @ ) or placebo ( n = @ ) for @weeks .


Changes in lipoprotein particle subclasses were determined by nuclear magnetic resonance spectroscopy .


At Week @ with last observation carried forward , colesevelam produced a reduction in total low-density lipoprotein ( LDL ) particle concentration ( baseline : @,@ nmol/L ; least-squares -LSB- LS -RSB- mean treatment difference : -@ nmol/L , p < @ ) versus placebo ; reductions were also seen in large , small , and very small LDL particle concentrations ( all p < @ ) .


There was also a reduction in total very low-density lipoprotein ( VLDL ) and chylomicron particle concentration ( baseline : @nmol/L ; LS mean treatment difference : -@ nmol/L , p = @ ) that resulted from a lowering in small VLDL particle concentration ( baseline : @nmol/L ; LS mean treatment difference : -@ nmol/L , p = @ ) .


In addition , with colesevelam there was an increase in total high-density lipoprotein ( HDL ) particle concentration versus placebo ( baseline : @mol/L ; LS mean treatment difference : +@ mol/L , p = @ ) , due to increases in the large ( baseline : @mol/L ; LS mean treatment difference : +@ mol/L , p = @ ) and medium ( baseline : @mol/L ; LS mean treatment difference : +@ mol/L , p = @ ) HDL subclasses .


Colesevelam monotherapy in subjects with T@DM resulted in generally favorable changes in certain lipoprotein subclass profiles compared with placebo .


Amino-terminal B-type natriuretic peptide ( NT-proBNP ) may detect early cardiac dysfunction in adults with tetralogy of Fallot ( ToF ) late after corrective surgery .


We aimed to determine the value of NT-proBNP in adults with ToF and establish its relationship with echocardiography and exercise capacity .


NT-proBNP measurement , electrocardiography and detailed @D-echocardiography were performed on the same day in @ consecutive adults with ToF ( mean age @ @ years , @ % male , @ % NYHA I , @ @ years after surgical correction ) .


Thirty-eight percent of the patients also underwent a cardiopulmonary-exercise test .


Median NT-proBNP was @ -LSB- IQR @-@ @ -RSB- pmol/L , and was elevated in @ % .


NT-proBNP correlated with right ventricular ( RV ) dilatation ( r = @ , p < @ ) and RV systolic dysfunction ( r = -@ , p = @ ) , but more strongly with LV systolic dysfunction ( r = -@ , p < @ ) , which was present in @ patients ( @ % ) .


Moderate or severe pulmonary regurgitation was not associated with higher NT-proBNP .


Tricuspid and pulmonary regurgitation peak velocities correlated with NT-proBNP ( r = @ , p < @ and r = @ , p = @ , respectively ) .


LV twist was measured with speckle-tracking echocardiography in @ patients .


An abnormal LV twist ( @ patients , @ % ) was associated with elevated NT-proBNP ( p = @ ) .


No relationship between NT-proBNP and exercise capacity was found .


NT-proBNP levels are elevated in more than @ % of adults with corrected ToF , while they are in stable clinical condition .


Higher NT-proBNP is most strongly associated with elevated pulmonary pressures , and with LV dysfunction rather than RV dysfunction .


NT-proBNP has the potential to become routine examination in patients with ToF to monitor ventricular function and may be used for timely detection of clinical deterioration .


Previous research has documented the feasibility of screening in emergency departments for adolescent suicide risk .


This randomized trial examined the effectiveness of Teen Options for Change ( TOC ) , an intervention for adolescents seeking general medical emergency services who screen positive for suicide risk .


Participants were @ youths , ages @ to @ , seeking services for nonpsychiatric emergencies .


They screened positive for suicide risk because of recent suicidal ideation , suicide attempt , or depression plus substance abuse .


Youths were randomly assigned to the TOC intervention or to enhanced treatment as usual .


Depression , hopelessness , and suicidal ideation were assessed at baseline and two months later .


Adolescents assigned to TOC showed greater reductions in depression than adolescents assigned to the comparison group ( Cohen 's d = @ , a large effect size ) .


Hopelessness , suicidal ideation , and substance abuse outcomes trended positively ( nonsignificantly ) , with small to moderate effect sizes .


TOC may be a promising , brief intervention for adolescents seeking emergency services and at risk of suicide .


This study aimed to investigate whether targeted retinal photocoagulation ( TRP ) for nonperfused areas ( NPAs ) could have a preventive effect on the recurrence of diabetic macular edema ( DME ) after intravitreal injection of bevacizumab ( IVB ) .


Eyes in the IVB group received @ mg IVB , and eyes in the IVB+TRP group received @ mg IVB combined with TRP of NPAs .


Two weeks before IVB administration , grid/focal photocoagulation ( PC ) had been performed in both groups .


After IVB treatment , the best corrected visual acuity ( BCVA ) and central retinal thickness ( CRT ) , determined by optical coherence tomography , were measured every month for @ months .


Fifty-two patients with DME were enrolled and randomized to an IVB group ( n = @ ) and an IVB+TRP group ( n = @ ) .


After IVB , the CRT decreased temporally , and the CRT significantly increased at @ months and thereafter in the IVB group but did not increase significantly in the IVB+TRP group .


Maximum increase in CRT after IVB was significantly correlated with the width of NPAs in the IVB group ( P = @ ) , but not in the IVB+TRP group .


Best corrected visual acuity in the IVB+TRP group was significantly better than that in the IVB group @ and @ months after treatment ( P < @ ) .


Targeted retinal photocoagulation for NPAs was effective to maintain the reduced CRT after grid/focal PC and IVB for patients with DME .


These results suggest that retinal ischemia is associated with the pathogenesis of recurrence of DME after IVB .


( www.umin.ac.jp/ctr number , UMIN@ . )


Smokers attend preferentially to cigarettes and other smoking-related cues in the environment , in what is known as an attentional bias .


There is evidence that attentional bias may contribute to craving and failure to stop smoking .