Patients were randomized to receive ipilimumab , @ mg/kg , intravenously on day @ plus sargramostim , @ g subcutaneously , on days @ to @ of a @-day cycle ( n = @ ) vs ipilimumab alone ( n = @ ) .


Ipilimumab treatment included induction for @ cycles followed by maintenance every fourth cycle .


Primary end point : comparison of length of OS .


Secondary end point : progression-free survival ( PFS ) , response rate , safety , and tolerability .


Median follow-up was @ months ( range , @-@ @ ) .


Median OS as of December @ for ipilimumab plus sargramostim was @ months ( @ % CI , @-not reached ) vs @ months ( @ % CI , @-not reached ) for ipilimumab .


The @-year survival rate for ipilimumab plus sargramostim was @ % ( @ % CI , @ % -@ % ) compared to @ % ( @ % CI , @ % -@ % ) for ipilimumab alone ( stratified log-rank @-sided P = @ ; mortality hazard ratio @ -LSB- @-sided @ % repeated CI , not applicable-@ @ -RSB- ) .


A planned interim analysis was conducted at @ % of expected events ( @ observed with @ expected deaths ) .


Planned interim analysis using the O'Brien-Fleming boundary was crossed for improvement in OS .


There was no difference in PFS .


Median PFS for ipilimumab plus sargramostim was @ months ( @ % CI , @-@ @ ) vs @ months ( @ % CI , @-@ @ ) for ipilimumab alone .


Grade @ to @ adverse events occurred in @ % ( @ % CI ; @ % -@ % ) of patients in the ipilimumab plus sargramostim group vs @ % ( @ % CI , @ % -@ % ) of patients in the ipilimumab-alone group ( @-sided P = @ ) .


Among patients with unresectable stage III or IV melanoma , treatment with ipilimumab plus sargramostim vs ipilimumab alone resulted in longer OS and lower toxicity , but no difference in PFS .


These findings require confirmation in larger studies with longer follow-up .


This paper aimed to evaluate the effects of coadministered immediate-release morphine and ethanol on safety , pharmacokinetic , and pharmacodynamic measures .


In the first stage of a randomized , double-blind , placebo-controlled , crossover study , @ healthy men with a history of moderate drinking received morphine @ mg + ethanol @ g/kg , morphine @ mg + ethanol placebo , and morphine placebo + ethanol @ g/kg .


In the second stage , participants received either a lower ( @ mg ) or higher ( @ mg ) morphine dose ( alone and in combination with ethanol ) depending on their tolerability to treatments in stage @ .


Safety , pharmacodynamic ( including visual analog scales , pupillometry , capnography , and psychomotor and cognitive measures ) , and pharmacokinetic assessments were conducted .


With the exception of one severe adverse event ( AE ) , all others were mild or moderate in intensity .


Morphine resulted in dose-related increases in AEs .


When morphine was administered with ethanol , similar AEs were observed ( dizziness , headache , somnolence , nausea , and vomiting ) , but these were sometimes more frequent compared with those observed with either drug alone .


No consistent additive or interaction effects were observed on pharmacodynamic measures .


Ethanol had no apparent effects on the pharmacokinetics of morphine or its metabolites .


Coadministration of single doses of morphine and ethanol tested in this study did not affect the safety , pharmacodynamics , or pharmacokinetics of morphine or ethanol administered alone .


Copyright @ John Wiley & Sons , Ltd. .


To assess the plaque removal efficacy of an oscillating-rotating power brush relative to a newly-introduced sonic power brush .


This study used a randomized , examiner-blind , single-center , two-treatment , parallel group @-week design .


Subjects with pre-existing plaque scores of at least @ on the Turesky Modification of the Quigley-Hein Plaque Index ( TMQHPI ) were evaluated for baseline whole mouth and approximal plaque scores .


They received either the oscillating-rotating brush ( Oral-B Professional Care @ , sold as Oral-B Professional Care @ in some regions , with the Oral-B Precision Clean brush head , D@u/EB@ ) or the sonic brush ( Colgate ProClinical C@ with Colgate Triple Clean brush head ) and brushed twice-daily with the assigned brush and a standard fluoride dentifrice for @ weeks before returning for plaque measurements .


Prior to baseline and the Week @ measurements , participants abstained from oral hygiene for @ hours and from eating , chewing gum and drinking for @ hours .


A total of @ subjects were enrolled in the study at baseline , with all completing the study : @ in the oscillating-rotating group , and @ in the sonic group .


Both brushes significantly reduced plaque over the @-week study period .


The oscillating-rotating brush was statistically significantly more effective in reducing plaque ( P < @ ) than the sonic brush .


Compared to the sonic power brush , the adjusted mean plaque reduction scores for the oscillating-rotating power brush were more than five times greater for whole mouth and approximal areas .


The objective of this study was to evaluate possible mechanisms for functional improvement and compare ambulation training with surface peroneal nerve stimulation vs. usual care via quantitative gait analysis .


This study is a randomized controlled clinical trial .


The setting of this study is a teaching hospital of an academic medical center .


One hundred ten chronic stroke survivors ( > @ wks poststroke ) with unilateral hemiparesis participated in this study .


The subjects were randomized to a surface peroneal nerve stimulation device or usual care intervention .


The subjects were treated for @ wks and followed up for @-mo posttreatment .


Spatiotemporal , kinematic , and kinetic parameters of gait were the main outcome measures .


Cadence ( F@ ,@ = @ , P = @ ) , stride length ( F@ ,@ = @ , P < @ ) , walking speed ( F@ ,@ = @ , P < @ ) , anterior-posterior ground reaction force ( F@ ,@ = @ , P = @ ) , peak hip power in preswing ( F@ ,@ = @ , P < @ ) , and peak ankle power at push-off ( F@ ,@ = @ , P = @ ) all improved with respect to time .


However , peak ankle ankle dorsiflexion in swing ( F@ ,@ = @ , P = @ ) worsened .


In general , the greatest change for all parameters occurred during the treatment period .


There were no significant treatment group time interaction effects for any of the spatiotemporal , kinematic , or kinetic parameters .


Gait training with peroneal nerve stimulation and usual care was associated with improvements in peak hip power in preswing and peak ankle power at push-off , which may have resulted in improved cadence , stride length , and walking speed ; however , there were no differences between treatment groups .


Both treatment groups also experienced a decrease in peak ankle ankle dorsiflexion in swing , although the clinical implications of this finding are unclear .


To investigate the effectiveness of four-channel FES based on a normal gait pattern on improving functional ability in subjects early after ischemic stroke .


Forty-five subjects were randomly assigned into a four-channel FES group ( n = @ ) , a placebo group ( n = @ ) , or a dual-channel group ( n = @ ) .


Stimulation lasted for @min in each session with @ session/day , @ days a week for @ weeks .


All subjects were assessed at baseline , at @ weeks of treatment , and at @ months after the treatment had finished .


The assessments included Fugl-Meyer Assessment ( FMA ) , the Postural Assessment Scale for Stroke Patients ( PASS ) , Berg Balance Scale ( BBS ) , Functional Ambulation Category ( FAC ) , and the Modified Barthel Index ( MBI ) .


All @ groups demonstrated significant improvements in all outcome measurements from pre - to posttreatment and further gains at followup .


The score of FMA and MBI improved significantly in the four-channel group at the end of the @ weeks of training .


And the scores of PASS , BBS , MBI , and FAC in the four-channel group were significantly higher than those of the placebo group .


This study indicated that four-channel FES can improve motor function , balance , walking ability , and performance of activities of daily living in subjects with early ischemic stroke .


Topical application of tranexamic acid to the knee joint before closure in total knee arthroplasty reduces postoperative bleeding without increase in complication .


However , it is unknown the effectiveness of topic TXA performed with other topical medications , like povidone-iodine solution .


One hundred and twenty-five patients were randomized to receive @mL of povidone-iodine solution ( control : group A ) or @ ( group B ) and @ g ( group C ) of topical TXA in povidone-iodine solution applied into the knee before closure in total knee arthroplasty .


The patients in the TXA groups had higher mean postoperative hemoglobin levels ( P = @ and P = @ in groups B and C , respectively ) and a reduced postoperative blood loss in the TXA groups ( P = @ and P = @ in groups B and C , respectively ) .


No significant complications were observed .


In this study , topical application of tranexamic acid after total knee arthroplasty together with povidone-iodine solution results in higher postoperative hemoglobin levels and lower blood loss compared with those in the control group without other complications .


I - I : high-powered prospective randomized trial .


Identifying pretreatment dietary habits that are associated with weight-loss intervention outcomes could help guide individuals ' selection of weight-loss approach among competing options .


A pretreatment factor that may influence weight-loss outcomes is macronutrient intake .


Overweight and obese Durham Veterans Affairs outpatients were randomised to a weight-loss intervention with a low-carbohydrate diet ( n = @ ) or orlistat medication therapy plus a low-fat diet ( n = @ ) .


Percentage fat , carbohydrate and protein intake prior to treatment were measured using @-day food records .


Linear mixed-effects models were used to determine whether pretreatment percentage macronutrient intake influenced weight trajectories and weight loss in each weight-loss condition .


Participant 's mean age was @ years , baseline body mass index was @ kg m ( -@ ) and @ % were male .


A higher pretreatment percentage carbohydrate intake was associated with less rapid initial weight loss ( P = @ ) and less rapid weight regain ( P = @ ) in the low-carbohydrate diet condition but was not associated with weight trajectories in the orlistat plus low-fat diet condition .


In both conditions , a higher pretreatment percentage fat intake was associated with more rapid weight regain ( P < @ ) .


Pretreatment percentage protein intake was not associated with weight trajectories .


None of the pretreatment macronutrients were associated with weight loss on study completion in either condition .


Selection of a weight-loss approach on the basis of pretreatment macronutrient intake is unlikely to improve weight outcomes at the end of a @-year treatment .


However , pretreatment macronutrient intake may have implications for tailoring of interventions to slow weight regain after weight loss .


Chronic severe tinnitus can be greatly detrimental to quality of life .


Some authors have reported benefit of repetitive transcranial magnetic stimulation , others of electrical cortical stimulation by stimulating the Heschl 's gyrus or secondary auditory areas .


To evaluate the efficacy of chronic electrical epidural stimulation of the auditory cortex on severe and disabling tinnitus .


In this double-blind randomized cross-over , patients with chronic ( at least @ years ) , severe ( Strukturierte Tinnitus-Interview , STI score > @ ) , unilateral or strongly lateralized tinnitus were included .


After open-phase stimulation for @ months , patients were randomized into @ groups for double-blind stimulation with cross-over between significant and non-significant phases and wash-out in between .


Each of the @ phases was @ weeks in duration .


Patients were chronically stimulated and followed if not explanted .


A decrease of STI score > @ % was considered as clinically significant .


None of the @ patients included achieved significant improvement during the double-blind phase .


Four were explanted , @ owing to lack of effect , one for breast cancer under the stimulator , and another for psychiatric decompensation .


Five are still stimulated .


Three felt slight to great subjective effectiveness , the remaining @ reported benefits and still requested stimulation .


This study did not find an objective efficiency of chronic cortical stimulation for severe and resistant tinnitus .


The discordance between the results in double-blind and open evaluations could be related to a placebo effect of surgery , but may also be explained by a poorly defined target , a too short randomized phase , or inappropriate outcome measures .


Clinical trial reference : NCT@ .


To evaluate critically visual field ( VF ) improvement in participants in the Collaborative Initial Glaucoma Treatment Study ( CIGTS ) .


Prospective , comparative case series from a randomized clinical trial comparing trabeculectomy and topical medications in treating open-angle glaucoma ( OAG ) .


A total of @ subjects with newly diagnosed OAG were identified for study .


Baseline and follow-up VF tests were obtained and mean deviation ( MD ) change from baseline over follow-up was analyzed .


Clinically substantial change ( loss or improvement ) was defined as change from baseline of @ decibels in MD. .


Baseline factors were inspected to determine their association with VF improvement in repeated measures regression models .


The percentage of participants showing substantial VF improvement over time was similar to that showing VF loss through @ years after initial treatment , after which VF loss became more frequent .


Measures of better intraocular pressure ( IOP ) control during treatment were significantly predictive of VF improvement , including a lower mean IOP , a lower minimum IOP , and lower sustained levels of IOP over follow-up .


Other predictive factors included female sex ( odds ratio -LSB- OR -RSB- = @ ) , visits @ year prior to cataract extraction ( OR = @ ) , and an interaction between treatment and baseline MD wherein surgically treated subjects with worse baseline VF loss were more likely to show VF improvement .


In the CIGTS , substantial VF loss and improvement were comparable through @ years of follow-up , after which VF loss became more frequent .


Predictive factors for VF improvement included several indicators of better IOP control , which supports the postulate that VF improvement was real .


To examine the effect of cost , a traditionally `` inactive '' trait of intervention , as contributor to the response to therapeutic interventions .


We conducted a prospective double-blind study in @ patients with moderate to severe Parkinson disease and motor fluctuations ( mean age @ @ years ; mean disease duration @ @ years ) who were randomized to a `` cheap '' or `` expensive '' subcutaneous `` novel injectable dopamine agonist '' placebo ( normal saline ) .


Patients were crossed over to the alternate arm approximately @ hours later .


Blinded motor assessments in the `` practically defined off '' state , before and after each intervention , included the Unified Parkinson 's Disease Rating Scale motor subscale , the Purdue Pegboard Test , and a tapping task .


Measurements of brain activity were performed using a feedback-based visual-motor associative learning functional MRI task .


Order effect was examined using stratified analysis .


Although both placebos improved motor function , benefit was greater when patients were randomized first to expensive placebo , with a magnitude halfway between that of cheap placebo and levodopa .


Brain activation was greater upon first-given cheap but not upon first-given expensive placebo or by levodopa .


Regardless of order of administration , only cheap placebo increased activation in the left lateral sensorimotor cortex and other regions .


Expensive placebo significantly improved motor function and decreased brain activation in a direction and magnitude comparable to , albeit less than , levodopa .


Perceptions of cost are capable of altering the placebo response in clinical studies .


This study provides Class III evidence that perception of cost is capable of influencing motor function and brain activation in Parkinson disease .


To compare two strategies for colorectal cancer screening : one-time colonoscopy versus fecal immunochemical testing ( FIT ) ( and colonoscopy for positive ) every @ years , in order to determine which strategy provides the highest participation and detection rates in groups of sex and age .


This analysis was performed with data from the first screening round within the COLONPREV study , a population-based , multicenter , nationwide trial carried out in Spain .


Several logistic regression models were applied to identify the influence of the screening test on participation rates and detection of proximal and distal neoplasms , as well to identify the influence of age and sex : women aged @-@ years , women aged @-@ years , men aged @-@ years , and men aged @-@ years .


Participation was higher in women than in men , especially among women aged @-@ years ( @ % for colonoscopy and @ % for FIT ) .


Crossover from colonoscopy to FIT was higher among women than men , especially among those aged @-@ years ( @ % ) .


In general , detection of any neoplasm and advanced adenoma was higher with colonoscopy than with FIT , but no significant differences were found between the two strategies for colorectal cancer detection .


Detection of advanced adenoma in both arms was lower in women -LSB- specifically in women aged @-@ years ( OR @ ; @ % CI @-@ @ ) than in men aged @-@ years -RSB- .


Women aged @-@ years in the colonoscopy arm had a higher probability of detection of advanced adenoma ( OR @ ; @ % CI @-@ @ ) , as well as of detection of neoplasms in proximal and distal locations ( proximal OR @ ; @ % CI @-@ @ ; distal OR @ ; @ % CI @-@ @ ) than women of the same age in the FIT arm .


These differences were also observed in the remaining groups but to a lesser extent .


Women were more likely to participate in a FIT-based strategy , especially those aged @-@ years .


The likelihood of detection of any neoplasm was higher in the colonoscopy arm for all the population groups studied , especially in women aged @-@ years .


Distinct population groups should be informed of the benefits of each screening strategy so that they may take informed decisions .


The inverse association between physical activity and cancer risk may be mediated by higher melatonin levels .


However , few studies have examined the effect of increased physical activity on melatonin levels .


The parent study was a randomized controlled trial that randomized @ men and @ women to a @-month moderate-to-vigorous aerobic exercise intervention ( `` exercisers '' ) and @ men and @ women to a stretching control ( `` controls '' ) .


Participants were of ages @ to @ years , and previously sedentary .


Levels of the principal urinary metabolite of melatonin , @-sulfatoxymelatonin ( aMT@s ) , corrected for creatinine levels , were measured in spot morning urine samples by immunoassay at baseline and @ months .


Changes in levels between exercisers and controls were compared using generalized estimating equations for linear regression .


We observed no statistically significant difference in the change in aMT@s levels from baseline to @ months in exercisers compared with controls ( change in aMT@s levels : exercisers , +@ % ; controls , +@ % ; P = @ ) .


There was no evidence of effect modification by age , sex , or body mass index .


A @-month moderate-intensity exercise intervention did not affect levels of aMT@s .


Further research needs to focus on other potential mechanisms through which physical activity may reduce the risk of cancer .


Cancer Epidemiol Biomarkers Prev ; @ ( @ ) ; @-@ @ AACR .


Studies from European-American cultures consistently reported that expressive suppression was associated with worse emotional consequence ( e.g. depression ) in comparison with acceptance .


However , this conclusion may not apply to Chinese , as suppressing emotional displays to maintain relational harmony is culturally valued in East Asian countries .


Thus , the present study examined the effects of suppression and acceptance on the depressive mood induced by a frustrating task in a Chinese sample .


Sixty-four subjects were randomly assigned to one of three instructions : suppression , acceptance or no-regulation during a frustrating arithmetic task .


The experience of depressive emotion and skin conductance response ( SCR ) were recorded during pre-frustration baseline , frustration induction and post-frustration recovery phases , respectively .


Compared with the control and acceptance instructions , suppression instruction was associated with decreased depressive experiences and smaller SCR activity during frustration .


There were no significant differences between acceptance and control groups in both subjective depression and SCR activity during frustration .


Moreover , the suppression group showed a better emotional recovery after the frustrating task , in comparison with the acceptance and control groups .


Correlation analyses verified that SCR reactivity was a reliable index of experienced depression during the frustration .


Expressive suppression is effective in reducing depressive experiences and depression-related physiological activity ( SCR ) when Chinese people are involved .


By contrast , the acceptance of depressive emotion in Chinese people does not produce a similar regulation effect .


These findings suggest that cultural context should be considered in understanding the emotional consequences of suppression and acceptance strategies .


We evaluated the efficacy and safety of obeticholic acid ( OCA , - ethylchenodeoxycholic acid ) in a randomized controlled trial of patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid therapy .


We performed a double-blind study of @ patients with primary biliary cirrhosis ( @ % women ) and levels of alkaline phosphatase ( ALP ) @ - to @-fold the upper limit of normal .


Patients were randomly assigned to groups given @ mg , @ mg , or @ mg doses of OCA or placebo , once daily for @ months .


Patients maintained their existing dose of ursodeoxycholic acid throughout the study .


The primary outcome was change in level of ALP from baseline ( day @ ) until the end of the study ( day @ or early termination ) .


We also performed an open-label extension of the trial in which @ patients were enrolled and @ completed the first year .


OCA was superior to placebo in achieving the primary end point .


Subjects given OCA had statistically significant relative reductions in mean ALP from baseline to the end of the study ( P < @ all OCA groups vs placebo ) .


Levels of ALP decreased @ % -@ % on average from baseline in the OCA groups and @ % in the placebo group .


Sixty-nine percent ( @ of @ ) of patients given OCA had at least a @ % reduction in ALP compared with @ % ( @ of @ ) of patients given placebo ( P < @ ) .


Among secondary end points , levels of - glutamyl transpeptidase decreased @ % -@ % , on average , among subjects given OCA , vs a @ % decrease in the group given placebo ; levels of alanine aminotransferase decreased @ % -@ % on average among subjects given OCA vs none of the patients given placebo .


Pruritus was the principal adverse event ; incidence values in the OCA @ mg , @ mg , and @ mg groups were @ % ( not significantly different ) , @ % ( P < @ ) , and @ % ( P < @ ) , respectively , vs @ % in the placebo group .


In the extension study , levels of ALP continued to decrease to a mean level of @ @ U/L after @ months vs @ @ U/L at baseline .


Daily doses of OCA , ranging from @ to @ mg , significantly reduced levels of ALP , - glutamyl transpeptidase , and alanine aminotransferase , compared with placebo , in patients with primary biliary cirrhosis who had inadequate responses to ursodeoxycholic acid .


The incidence and severity of pruritus were lowest among patients who received @ mg/d OCA .


Biochemical responses to OCA were maintained in a @-month open-label extension trial .


ClinicalTrials.gov ID : NCT@ .


Functional endoscopic sinus surgery ( FESS ) is the mainstay of surgical treatment for sinonasal disease .


This surgery carries certain risks .


Most of these risks relate to the quality of the surgical field .


Thus , mechanisms by which the surgical field can be improved are important to study .


We sought to determine whether positive end-expiratory pressure ( PEEP ) had a deleterious effect on the quality of the surgical field in patients undergoing primary FESS .


Forty-seven patients were randomized to a ventilation strategy using either @ cm H@O of PEEP or zero added PEEP .


The quality of the surgical field was measured every @ minutes using a validated surgical scoring method .


The addition of PEEP did not have any measurable effect on the surgical field scores after onset of surgery ( odds ratio -LSB- OR -RSB- ( @ % confidence interval -LSB- CI -RSB- ) = @ ( @-@ @ ) , P = @ for side @ ; OR ( @ % CI ) = @ ( @-@ @ ) , P = @ for side @ ) .


The peak inspiratory pressure did have an effect on surgical grades .


Every cm H@O of added pressure over @ cm H@O total pressure contributing to increased odds of higher surgical field score .


For each cm H@O increase in inspiratory pressure above @cm H@O increased the surgical field score ( OR -LSB- @ % CI -RSB- @ -LSB- @-@ @ -RSB- , P = @ ) .


During FESS surgery if PEEP is added , it is important to keep the mean inspiratory pressure below @cm H@O to avoid worsening surgical field conditions .


In Japan , a traditional herbal medicine , Tokishigyakukagoshuyushokyoto ( TJ-@ ) , is often used for the treatment of peripheral coldness , which is a common complaint among Japanese women .


However , the effects of this herbal medicine have yet to be examined in a randomized controlled trial .


In the current study , the effect of TJ-@ on the peripheral blood flow in women experiencing peripheral coldness was investigated using a parallel-group randomized controlled trial .


Fifty-eight women aged @ to @ years with peripheral coldness were randomly divided into the intervention or control group .


They were examined using cold bathing tests , physical examinations , and questionnaires in January @ for the baseline and in March @ for the follow-up , and January @ and March @ , respectively .


At the baseline , there were no differences in clinical characteristics between the two groups .


In the intervention group , peripheral coldness improved after the intervention term ; however , it persisted in the control group .


Mean values of percentage recovery of the peripheral blood flow after cold bathing tests were @ % and -@ % for the intervention and control groups , respectively ( p = @ ) , and the proportions for percentage recovery of > @ % were @ % and @ % , respectively ( p = @ ) .


Mean values of percent recovery of skin temperature did not differ between the two groups .


The present clinical trial supports that a traditional herbal medicine relieves peripheral coldness in women probably through the improvement of peripheral blood flow .


The aim of this study was to compare CKD-@ ( test docetaxel ) with Taxotere ( ) ( reference docetaxel ) in terms of pharmacokinetics and safety for patients with advanced or metastatic carcinoma .


A randomized , open-label , two-way crossover study was conducted in eligible patients .


Patients received with reference or test drugs of @ mg/m ( @ ) docetaxel by intravenous infusion for @ min in the first period and the alternative drug in the second period with a washout of @ weeks .


Plasma concentrations of docetaxel were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection .


Pharmacokinetic parameters , including the maximum plasma concentration ( C ( max ) ) and the area under the concentration-time curve ( AUC ) , were determined by non-compartmental analysis .


A total of @ patients were included in the study , @ patients received test drug and @ received reference drug for the first cycle .


The C ( max ) of docetaxel was @,@ ng/mL for test drug and @,@ ng/mL for reference drug , and two drugs showed no difference with a statistical significance .


Time to reach C ( max ) ( T ( max ) ) of CKD-@ ( @ h ) versus reference docetaxel ( @ h ) was also not significantly different .


Other pharmacokinetic parameters including the plasma AUC , elimination half-life , and total body clearance exhibited similar values without a significant difference .


The most common grade @ or @ toxicity was neutropenia ( CKD-@ @ or @ % ; reference docetaxel @ or @ % ) .


Febrile neutropenia was experienced by only one patient in each group .


Two patients died of progression of disease during the study .


Docetaxel anhydrous CKD-@ use with patients suffering advanced or metastatic solid malignancies was equivalent to reference docetaxel in terms of pharmacokinetic parameters and safety profile .


Additionally , the test and reference drug met the regulatory criteria for pharmacokinetic equivalence .


Young adulthood is a critical transition period for the development of health behaviors .


We present here the results of a randomized controlled trial of an online avatar-hosted personal health makeover program designed for young adult smokers .


We conducted a three-group randomized trial comparing delivery of general lifestyle content ( Tx@ ) , personally tailored health information ( Tx@ ) , and personally tailored health information plus online video-based peer coaching ( Tx@ ) as part of a @-week online health program .


Participants were asked to set weekly goals around eating breakfast , exercise , alcohol use , and cigarette smoking .


Eligibility criteria included age ( @-@ years ) and smoking status ( any cigarette use in the previous @ days ) .


The primary outcome was self-reported @-day abstinence measured @ weeks postenrollment .


Participant ( n = @ ) characteristics were balanced across the groups ( @ % women , mean age @ , @ % nonwhite , @ % high school education or less , and @ % daily smokers ) .


Considering intention to treat , @-day smoking abstinence rates were statistically significantly higher in the intervention groups ( Tx@ = @ % , Tx@ = @ % , Tx@ = @ % , P < @ ) .


Participants in the intervention groups were also more likely to reduce their number of days spent on binge drinking and increase their number of days eating breakfast and exercising .


Overall , intervention group participants were much more likely to make positive changes in at least three or four of the target behaviors ( Tx@ = @ % , Tx@ = @ % , Tx@ = @ % , P < @ ) .


This online avatar-hosted personal health makeover `` show '' increased smoking abstinence and induced positive changes in multiple related health behaviors .


Addition of the online video-based peer coaching further improved behavioral outcomes .


Baseline abstinence goal is a robust predictor of cigarette abstinence .


However , important questions about goal remain unanswered .


These include variables correlating with goal , changes in goal , relationship of goal and abstinence status over time , and predictors of change .


The current study aimed to address these questions .


Participants were treatment-seeking volunteers in two clinical trials .


In Clinical Trial @ ( N = @ ) , participants smoked @ cigarettes per day ( CPD ) and were @years of age .


In Clinical Trial @ ( N = @ ) , participants smoked @ CPD , smoked within @min of arising , and were @years of age .


The outcome variables were biochemically verified @-day abstinence from cigarettes at weeks @ , @ , @ , and @ .


Abstinence goal , demographic , psychological , and smoking related variables were assessed via standard instruments .


At baseline , the greater the desire to quit and one 's expectations of success , and the lesser the educational level , the more likely participants were to have a quit forever goal .


Throughout the two-year study , abstinence from cigarettes and a lower educational level were correlated with a goal of quit forever ; @ % of participants changed goal .


There were no predictors of goal change .


Abstinence goal was related to abstinence status across the study period .


The goal predicted abstinence status at subsequent assessments , even when status was controlled .


Lesser educational levels were consistent predictors of a more stringent goal .


Abstinence goal changes over time .


These findings suggest that repeated counseling about goal is advisable and participants would benefit from such counseling , independent of demographic characteristics and smoking status .


We investigated the satisfaction of patients and endoscopists and concurrently safety aspects of an `` alfentanil only '' and two clinically routinely used sedation regimes in patients undergoing colonoscopy in a teaching hospital .


One hundred and eighty patients were prospectively randomized in three groups : M ( midazolam/fentanyl ) , A ( alfentanil ) , and P ( propofol/alfentanil ) ; M and A were administered by an endoscopy nurse , P by an anesthesia nurse .


Interventions , heart rate , saturation , electrocardiogram , noninvasive blood pressure , and expiratory CO were monitored using video assistance .


After endoscopy , patients and gastroenterologists completed questionnaires about satisfaction .


A high level of satisfaction was found in all groups , with patients in group P being more satisfied with their sedation experience ( median @ , p < @ ) .


Gastroenterologist satisfaction varied not significantly between the three alternatives .


Patients in group A felt less drowsy , could communicate more rapidly than patients in both other groups , and met discharge criteria immediately after the end of the procedure .


Respiratory events associated with sedation were observed in @ % patients in group M , @ % in group P , but only @ % in group A ( p < @ ) .


These results suggest that alfentanil could be an alternative for sedation in colonoscopy even in the setting of a teaching hospital .


It results in satisfied patients easily taking up information , and recovering rapidly .


Although one might expect to observe more respiratory depression with an `` opioid only '' sedation technique without involvement of anesthesia partners , respiratory events were less frequent than when other methods were used .


`` Difficult visits '' are common in primary care and may contribute to primary care provider ( PCP ) career dissatisfaction and burnout .


Patient requests occur in approximately half of primary care visits and may be a source of clinician-patient miscommunication or conflict , contributing to perceived visit difficulty .


We aimed to determine associations between types of patient requests and PCP-perceived visit difficulty .


This was an observational study , nested in a multicenter randomized trial of depression engagement interventions .


We included @ patient visits within @ PCP practices in Northern California occurring from June @ to March @ .


PCP-perceived visit difficulty was quantified using a three-item scale ( relative visit difficulty , amount of effort required , and amount of time required ; Cronbach 's = @ ) .


Using linear regression , the difficulty scale ( score range @-@ from least to most difficult ) was modeled as a function of : patient requests for diagnostics tests , pain medications , and specialist referrals ; PCP perception of likely depression or likely substance abuse ; patient sociodemographics , comorbidity , depression ; PCP characteristics and practice setting .


Patients requested diagnostic tests , pain medications , and specialist referrals in @ , @ and @ % of visits , respectively .


After adjustment for patient medical and psychiatric complexity , perceived difficulty was significantly higher when patients requested diagnostic tests -LSB- parameter estimate ( PE ) @ , ( @ % CI : @ , @ ) -RSB- but not when patients requested pain medications -LSB- PE -@ ( @ % CI : -@ , @ ) -RSB- or referrals -LSB- PE @ ( @ % CI : -@ , @ ) -RSB- .


PCP-perceived visit difficulty is associated with patient requests for diagnostic tests , but not requests for pain medications or specialist referrals .


In this era of `` choosing wisely , '' PCPs may be challenged to respond to diagnostic test requests in an evidence-based manner , while maintaining the provider-patient relationship and PCP career satisfaction .


To determine whether the Canine Orthopedic Index ( COI ) can detect changes in dogs with osteoarthritis ( OA ) treated with either non-steroidal anti-inflammatory drugs ( NSAID ) or placebo .


Double blind randomized placebo controlled trial .


Dogs ( n = @ ) with OA .


Owners completed the COI on Day @ .


Dogs were administered either carprofen or placebo on days @ through @ .


Owners completed the COI again on Day @ .


The change in total instrument , stiffness , gait , function , and quality of life scores were assessed between groups .


Dogs administered carprofen had significant decreases in the total instrument score ( P = @ ) as well as @ of the @ factor scores compared to dogs treated with placebo ( stiffness score P = @ ; gait score P = @ ; and function score = @ ) .


The change in quality of life score was not significantly different between carprofen and placebo treated dogs ( P = @ ) .


The COI delivered the decreases in total instrument , stiffness , gait , and function scores that one would expect in dogs with OA treated with an NSAID compared with placebo administration .


In this cohort of dogs , the quality of life score was not sensitive to the changes associated with NSAID administration .


Various voice therapy techniques include not only phonation exercises but also measure to regulate tonus of non-larynx related muscles .


This is based on the belief that the use of non-laryngeal muscles may affect laryngeal muscle action during phonation onset und phonation .


Here we raised the question if indeed a well defined activation of muscles distant to the larynx may effect phonation onset time and the vibratory cycles following thereafter .


Prospective partly randomized single center pilot study with @ healthy volunteers .


Analysed variables were time of phonation onset and closed quotient ( Qx ) derived via electroglottgraphy .


According to a randomization protocol volunteers had to press a training device ( + condition ) or to keep the hand quiet ( - condition ) .


Comparism of both conditions did not reveal any significant difference , however Qx tended to be higher in the + condition .


The data presented here does not confirm that activation of hand muscles influences phonation onset time .


However the preceding vibratory cycles may be altered towards a higher tone of intralaryngeal muscles regulating vocal fold tension .


Further studies including more volunteers or patients with functional voice disorders and protocols employing the activation of other muscle groups are warranted in order to shed more light into the interrelationship between larynx and other muscle activation during phonation .


This study was aimed to evaluate the accuracy of `` True Fast Imaging with Steady-State Precession '' ( TrueFISP ) MR angiography ( MRA ) for diagnosis of renal arterial stenosis ( RAS ) in hypertensive patients .


Twenty-two patients underwent both TrueFISP MRA and contrast-enhanced MRA ( CE-MRA ) on a @-T MR imager .


Volume of main renal arteries , length of maximal visible renal arteries , number of visualized branches , stenotic grade , and subjective quality were compared .


Paired @-tailed Student t test and Wilcoxon signed rank test were applied to evaluate the significance of these variables .


Volume of main renal arteries , length of maximal visible renal arteries , and number of branches indicated no significant difference between the @ techniques ( P > @ ) .


Stenotic degree of @ RAS was greater on CE-MRA than on TrueFISP MRA .


Qualitative scores from TrueFISP MRA were higher than those from CE-MRA ( P < @ ) .


TrueFISP MRA is a reliable and accurate method for evaluating RAS .


The Roland Morris Questionnaire ( RMQ ) is a widely used health status measure for low back pain ( LBP ) .


It is not preference-based , and there are currently no established algorithms for mapping between the RMQ and preference-based health-related quality-of-life measures .


Using data from randomized controlled trials of treatment for LBP , we sought to develop algorithms for mapping between RMQ scores and health utilities derived using either the EuroQol five-dimensional questionnaire ( EQ-@D ) or the six-dimensional health state short form ( derived from Medical Outcomes Study @-Item Short-Form Health Survey ) ( SF-@D ) .


This study is based on data from the Back Skills Training Trial in which data were collected from @ patients at baseline and subsequently at @ , @ , and @ months postrandomization using a range of outcome measures , including the RMQ , the EQ-@D , and the Short Form @ item Health Survey ( SF-@ ) ( from which SF-@D utilities can be derived ) .


We used baseline trial data to estimate models using both direct and response mapping approaches to predict EQ-@D and SF-@D health utilities and dimension responses .


A multistage model selection process was used to assess the predictive accuracy of the models .


We then explored different techniques and mapping models that made use of repeated follow-up observations in the data .


The estimated mapping algorithms were validated using external data from the UK Back Pain Exercise and Manipulation trial .


A number of models were developed that accurately predict health utilities in this context .


The best performing model for RMQ to EQ-@D mapping was a beta regression with Bayesian quasi-likelihood estimation that included @ dummy variables for RMQ responses , age , and sex as covariates ( mean squared error @ ) based on repeated data .


The model selected for RMQ to SF-@D mapping was a finite mixture model that included the overall RMQ score , age , sex , RMQ score squared , age squared , and an interaction term for age and RMQ score as covariates ( mean squared error @ ) based on repeated data .


It is possible to reasonably predict EQ-@D and SF-@D health utilities from RMQ scores and responses using regression methods .


Our regression equations provide an empirical basis for estimating health utilities when EQ-@D or SF-@D data are not available .


They can be used to inform future economic evaluations of interventions targeting LBP .


To investigate the role of preoperative biometry for selecting initial contact lens power .


Patients randomized to receive contact lenses in the Infant Aphakia Treatment Study ( IATS ) were retrospectively analyzed .


Inclusion criteria were availability of both a preoperative immersion axial length measurement and a @-month postoperative refractive value .


The target contact lens power for distance was determined using @-month postoperative spherical equivalent refraction ( after adjusting for a vertex distance ) over the known contact lens power .


We compared targeted contact lens power for distance with three other treatment techniques : ( @ ) @ D contact lens ( @ D minus @ D overcorrection for near vision based on IATS protocol ) ; ( @ ) regression-estimated contact lens power of @ - @ axial length ; and ( @ ) IOL power calculated using the Sanders-Retzlaff-Kraff ( SRK/T ) regression formula with a modified A-constant ( @ ) .


Prediction error ( targeted minus estimated contact lens power ) and its absolute values were calculated .


A total of @ eyes of @ patients met inclusion criteria .


Age at the time of cataract surgery was @ @ months .


Follow-up refraction was performed at @ @ days after surgery .


Target contact lens power for distance was @ @ D for the IATS cohort ( which excluded infants with corneal diameter < @ mm ) .


The mean prediction error was -@ , -@ , and -@ D and mean absolute prediction error was @ , @ , and @ D , respectively , for @ D contact lens , regression , and SRK/T-estimated power .


Preoperative biometry can be used to estimate contact lens power for distance if an accurate refraction can not be obtained initially .


Despite the availability of psychosocial evidence-based practices ( EBPs ) , treatment and outcomes for persons with mental disorders remain suboptimal .


Replicating Effective Programs ( REP ) , an effective implementation strategy , still resulted in less than half of sites using an EBP .


The primary aim of this cluster randomized trial is to determine , among sites not initially responding to REP , the effect of adaptive implementation strategies that begin with an External Facilitator ( EF ) or with an External Facilitator plus an Internal Facilitator ( IF ) on improved EBP use and patient outcomes in @ months .


This study employs a sequential multiple assignment randomized trial ( SMART ) design to build an adaptive implementation strategy .


The EBP to be implemented is life goals ( LG ) for patients with mood disorders across @ community-based outpatient clinics ( N = @,@ patients ) from different U.S. regions .


Sites not initially responding to REP ( defined as < @ % patients receiving @ EBP sessions ) will be randomized to receive additional support from an EF or both EF/IF .


Additionally , sites randomized to EF and still not responsive will be randomized to continue with EF alone or to receive EF/IF .


The EF provides technical expertise in adapting LG in routine practice , whereas the on-site IF has direct reporting relationships to site leadership to support LG use in routine practice .


The primary outcome is mental health-related quality of life ; secondary outcomes include receipt of LG sessions , mood symptoms , implementation costs , and organizational change .


This study design will determine whether an off-site EF alone versus the addition of an on-site IF improves EBP uptake and patient outcomes among sites that do not respond initially to REP. It will also examine the value of delaying the provision of EF/IF for sites that continue to not respond despite EF .


Tonsillectomy causes discomfort in children .


Positive therapeutic suggestions ( TS ) may be given to patients while they are emerging from general anesthesia as a potential tool to decrease distress .


This study examined impact of TS on outcomes , when delivered to children emerging from general anesthesia post tonsillectomy .


A double blinded randomized controlled trial was conducted with @ patient/parent pairs .


TS and noise recordings were played via headphones post tonsillectomy upon arrival to the Post Anesthesia Care Unit until the child showed signs of waking .


Pain scores at @ minutes post extubation show significantly lower pain in the TS group , P = @ ( Mann Whitney U for independent samples ) .


The TS group had @ % increased likelihood of receiving less intravenous ( IV ) opioid .


TS may help lower pain in children post tonsillectomy and decrease demand for IV opioid pain management in the @ - to @-year-old tonsillectomy population .


Hemorrhage and liver failure are the two major complications in partial hepatectomy .


The finger fracture or clamp crushing technique has been a standard technique used for transection of liver parenchyma .


Hepatic vascular Inflow occlusion ( Pringle maneuver , PM ) is often used to minimize blood loss , but hepatic ischemia-reperfusion may result with an increased risk of post-operative liver failure .


The Harmonic scalpel ( HS ) has been shown to be effective in reducing blood loss during liver parenchymal transection without any hepatic vascular inflow occlusion .


A randomized controlled trial was carried out to evaluate the impact of the two different hepatic transection techniques .


The post-operative short-term results were compared .


During the study period , @ of @ patients who received partial hepatectomy in our hospital were randomized into @ groups : the PM group ( n = @ ) and the HS group ( n = @ ) .


The numbers of patient who had a poor liver function on post-operative day @ ( ISLGS Grade B ) were @ , and @ , respectively ( p < @ ) .


The post-operative complication rate was significantly higher in the PM group ( @ % versus @ % , p < @ ) .


The HS group had significantly less blood loss and blood transfusion requirements than the PM group ( p < @ ) .


In conclusion , liver resection carried out using HS without hepatic vascular occlusion was better than using finger fracture or clamp crushing technique with Pringle maneuver .


The use of HS allowed liver resection to be safely performed , with earlier recovery of liver function , and less surgical complication .


To evaluate the rotational stability of a new one-piece hydrophobic acrylic toric intraocular lens ( IOL ) using a custom-developed software for analysis of slit-lamp photographs .


In a prospective , multicenter study , @ eyes were implanted with the TECNIS Toric IOL ( Abbott Medical Optics , Inc. , Santa Ana , CA ) .


A custom-developed software was used to analyze high-resolution slit-lamp photographs of @ eyes taken at day @ ( baseline ) and @ , @ , and @ months postoperatively .


The software uses iris and sclera landmarks to align the baseline image and later images for comparison .


Validation of software was performed through repeated analyses of protractor images rotated from @ to @ and randomly selected photographs of @ eyes .


Software validation showed precision ( repeatability plus reproducibility variation ) of @ using protractor images and @ using slit-lamp photographs .


Good quality slit-lamp images and clear landmarks were necessary for precise measurements .


At @ months , @ % of eyes had @ or less change in IOL orientation versus baseline ; only @ eyes ( @ % ) had axis shift greater than @ .


Most eyes were within @ or less of rotation between @ and @ months ( @ % ) and @ and @ months ( @ % ) .


Mean absolute axis change ( standard deviation ) from @ day to @ months was @ @ .


The new custom software was precise and quick in analyzing slit-lamp photographs to determine postoperative toric IOL rotation .


The aim was to compare real-time language/cognitive processing in picture naming in adults who stutter ( AWS ) versus typically-fluent adults ( TFA ) .


Participants named pictures preceded by masked prime words .


Primes and target picture labels were identical or mismatched .


Priming effects on naming and picture-elicited ERP activity were analyzed .


Vocabulary knowledge correlations with these measures were assessed .


Priming improved naming RTs and accuracy in both groups .


RTs were longer for AWS , and correlated positively with receptive vocabulary in TFA .


Electrophysiologically , posterior-P@ amplitude negatively correlated with expressive vocabulary in TFA versus receptive vocabulary in AWS .


Frontal/temporal-P @ amplitude correlated positively with expressive vocabulary in AWS .


Identity priming enhanced frontal/posterior-N @ amplitude in both groups , and attenuated P@ amplitude in AWS .


N@ priming was topographically-restricted in AWS .


Results suggest that conceptual knowledge was perceptually-grounded in expressive vocabulary in TFA versus receptive vocabulary in AWS .


Poorer expressive vocabulary in AWS was potentially associated with greater suppression of irrelevant conceptual information .


Priming enhanced N@-indexed cognitive control and visual attention in both groups .


P@-indexed focal attention attenuated with priming in AWS only .


Topographically-restricted N@ priming suggests that lemma/word form connections were weaker in AWS .


Real-time language/cognitive processing in picture naming operates differently in AWS .


l-Theanine ( N-ethyl-l-glutamine ) is an amino acid uniquely found in green tea .


Growing evidence has suggested the possible effects of l-theanine on cognition .


Previously , we found that l-theanine attenuates MK-@-induced deficit in prepulse inhibition ( PPI ) in mice .


In this study , we examined the effect of l-theanine in increasing the PPI in healthy humans .


The subjects were @ healthy adults who underwent PPI testing as a measure of sensorimotor gating @min after an oral intake of l-theanine ( @ , @ , @ , or @mg ) .


PPI tests were done by examiners who were blind to the dose .


The administration of @mg of l-theanine and that of @mg , but not @mg , significantly increased the % PPI compared to the baseline ( @mg ) .


There was no significant relation between the dose of l-theanine and the startle magnitude or the habituation of startle response .


The plasma concentrations of l-theanine correlated with the dose of l-theanine .


The observed effect with @-@mg of l-theanine on PPI suggested that l-theanine at a particular dose range increases sensorimotor gating in humans .


Estimate the efficacy of amoxicillin for acute uncomplicated lower-respiratory-tract infection ( LRTI ) in primary care and demonstrate the use of randomisation-based efficacy estimators .


Secondary analysis of a two-arm individually-randomised placebo-controlled trial .


Primary care practices in @ European countries .


Patients aged @ or older consulting with an acute LRTI in whom pneumonia was not suspected by the clinician .


Amoxicillin ( two @mg tablets three times a day for @days ) or matched placebo .


Clinician-rated symptom severity between days @-@ ; new/worsening symptoms and presence of side effects at @-weeks .


Adherence was captured using self-report and tablet counts .


@ participants were randomised to the amoxicillin or placebo group .


On average , @ % of the prescribed amoxicillin was taken .


The original analysis demonstrated small increases in both benefits and harms from amoxicillin .


Minor improvements in the benefits of amoxicillin were observed when an adjustments for adherence were made ( mean difference in symptom severity -@ , @ % CI -@ to @ , OR for new/worsening symptoms @ , @ % CI @ to @ ) as well as minor increases in harms ( OR for side effects @ , @ % CI @ to @ ) .


Adherence to amoxicillin was high , and the findings from the original analysis were robust to non-adherence .


Participants consulting to primary care with an acute uncomplicated LRTI can on average expect minor improvements in outcome from taking amoxicillin .


However , they are also at an increased risk of experiencing side effects .


To determine whether an online support tool can impact anxiety in women experiencing an abnormal mammogram .


We developed an online support system using the Comprehensive Health Enhancement Support System ( CHESS ) designed for women experiencing an abnormal mammogram as a model .


Our trial randomized @ of these women to online support ( the intervention group ) or to a list of five commonly used Internet sites ( the comparison group ) .


Surveys assessed anxiety and breast cancer worry , and patient satisfaction at three important clinical time points : when women were notified of their abnormal mammogram , at the time of diagnostic imaging , and at the time of biopsy ( if biopsy was recommended ) .


Study participants in the intervention group showed a significant decrease in anxiety at the time of biopsy compared to the comparison group ( p = @ ) .


However , there was no significant difference in anxiety between the intervention group and the comparison group at the time of diagnostic work-up .


We discontinued assessment of patient satisfaction after finding that many women had substantial difficulty answering the questions that referenced their physician , because they did not understand who their physician was for this process of care .


The combination of the inability to identify the physician providing care during the mammography work-up and anxiety effects seen only after an interaction with the breast imaging team may indicate that online support only decreases the anxiety of women in concert with direct interpersonal support from the healthcare team .


Patients with advanced cancer have reduced quality of life , which tends to worsen towards the end of life .


We assessed the effect of early palliative care in patients with advanced cancer on several aspects of quality of life .


The study took place at the Princess Margaret Cancer Centre ( Toronto , ON , Canada ) , between Dec @ , @ , and Feb @ , @ medical oncology clinics were cluster randomised ( in a @:@ ratio , using a computer-generated sequence , stratified by clinic size and tumour site -LSB- four lung , eight gastrointestinal , four genitourinary , six breast , two gynaecological -RSB- ) , to consultation and follow-up ( at least monthly ) by a palliative care team or to standard cancer care .


Complete masking of interventions was not possible ; however , patients provided written informed consent to participate in their own study group , without being informed of the existence of another group .


Eligible patients had advanced cancer , European Cooperative Oncology Group performance status of @-@ , and a clinical prognosis of @-@ months .


Quality of life ( Functional Assessment of Chronic Illness Therapy -- Spiritual Well-Being -LSB- FACIT-Sp -RSB- scale and Quality of Life at the End of Life -LSB- QUAL-E -RSB- scale ) , symptom severity ( Edmonton Symptom Assessment System -LSB- ESAS -RSB- ) , satisfaction with care ( FAMCARE-P@ ) , and problems with medical interactions ( Cancer Rehabilitation Evaluation System Medical Interaction Subscale -LSB- CARES-MIS -RSB- ) were measured at baseline and monthly for @ months .


The primary outcome was change score for FACIT-Sp at @ months .


Secondary endpoints included change score for FACIT-Sp at @ months and change scores for other scales at @ and @ months .


This trial is registered with ClinicalTrials.gov , number NCT@ .


@ patients completed baseline measures ( @ intervention , @ control ) ; @ completed at least one follow-up assessment .


At @-months , there was a non-significant difference in change score for FACIT-Sp between intervention and control groups ( @ points -LSB- @ % CI -@ to @ -RSB- , p = @ ) , a significant difference in QUAL-E ( @ -LSB- @ to @ -RSB- , p = @ ) and FAMCARE-P@ ( @ -LSB- @ to @ -RSB- , p = @ ) , and no difference in ESAS ( -@ -LSB- -@ to @ -RSB- , p = @ ) or CARES-MIS ( -@ -LSB- -@ to @ -RSB- , p = @ ) .


At @ months , there were significant differences in change scores for all outcomes except CARES-MIS .


All differences favoured the intervention group .


Although the difference in quality of life was non-significant at the primary endpoint , this trial shows promising findings that support early palliative care for patients with advanced cancer .


To evaluate the @-month clinical effects of one scaling and root planing ( SRP ) procedure alone or combined with local administration of hydrogen peroxide gel ( with or without inclusion of doxycycline for @ weeks ) using periodontal medicament carriers in the form of customized prescription trays for treatment of subjects with chronic periodontitis .


Using a randomized controlled design , @ subjects with moderate to advanced periodontitis were assigned to three parallel treatment groups : @ ) SRP combined with prescription-tray ( Perio Tray ) application of @ % hydrogen peroxide gel ( Perio Gel ) and , for the first @ weeks , doxycycline , @ ) SRP combined with prescription-tray application of peroxide gel , and @ ) SRP alone .


All subjects brushed twice daily with standard dentifrice and toothbrush for a @-week acclimation phase , and continued this regimen throughout the @-month treatment phase .


Pocket probing depth ( PPD ) and bleeding index ( BI ) were assessed on natural and restored sites at baseline and after @ , @ , @ , and @ weeks .


SRP was performed @ weeks after baseline .


Clinical variables were compared by ANCOVA and paired t-tests after each treatment interval , analyzing natural and restored sites separately .


@ subjects completed the trial .


Analysis of pockets > @ mm at baseline showed that mean PPD for both test groups significantly decreased from baseline approximately @ mm prior to SRP .


Two weeks following SRP , mean PPD significantly decreased from baseline by > @ mm for both test groups and @ mm for the control .


By @ weeks , mean PPD decreased > @ mm for both test groups compared to @ mm for the SRP-only control ( P < @ for test versus control at all post-SRP comparisons ) .


Analysis of pockets @ mm at baseline showed the same relationship between groups ( P < @ for test versus control ) .


Mean BI dropped significantly only for test groups before SRP , and the tray/peroxide-doxycycline group was significantly different from the control ( P = @ ) .


Two weeks post-SRP , mean BI reductions for test groups were significantly greater than the control , and remained so for most comparisons .


For restored sites , mean PPDs of both test groups were significantly better ( P < @ ) than the control for all post-baseline comparisons .


To identify the effectiveness of rational-emotive-behavior-based therapy ( REBT-based therapy ) on improved mental health and antiretroviral ( ART ) therapeutic adherence in women infected with HIV/AIDS ( female subjects with HIV/AIDS ) .


A randomized and single-blinded clinical trial in women infected with HIV/AIDS who had their treatment at the outpatient clinic of Pokdiksus AIDS RSCM and at the AIDS Comprehensive Diagnostic Unit of Dharmais Hospital was conducted between October @ and March @ .


A block randomization of @ female subjects with AIDS was performed that resulted in a REBT-based treatment group ( n = @ ) and a control group ( n = @ ) .


The treatment group received REBT-based intervention of @ sessions weekly including @ individual-therapeutic sessions/week and @ group-therapeutic sessions/week .


Instruments used in the study were questionnaires on demography , ART adherence ( measured by self report and pill count ) , and mental health ( SRQ-@ ) .


Data were analyzed using Chi-Square test , Generalized Linear Model , and Generalized Estimating Equations .


There were @ respondents analyzed including in the REBT-based group ( n = @ ) and in the control group ( n = @ ) with mean age of @-@ years .


After @ weeks of REBT-based intervention , there was improved ( increased ) mean value of the self-reported adherence score ( self-report ) compared to control group ( @ % ; CI @ % ,@ -@ vs. @ % ; CI @ % ,@ -@ ) and improved ( decreased ) SRQ-@ mean score in REBT-based treatment group compared to control group ( @ ; CI @ % , @-@ @ vs. @ ; CI @ % : @-@ @ ) .


ART adherence based on viral load titer was not analyzed in both group since most of VL titer were undetected ( < @ copies/mL ) .


GLM analysis showed decreased SRQ-@ mean score and increased mean value of self-reported ART adherence ( self-report ) in the REBT-based treatment group , which were more significant ( p < @ ) than control group on the @th week .


GEE analysis showed that @ point decrement of SRQ-@ would increase self-reported ART adherence as much as @ point and the correlation was statistically significant ( p < @ ) .


After @ weeks of REBT-based intervention to female subjects with HIV/AIDS , there is a decrease of SRQ-@ mean score which may result in increased ART adherence mean score in the treatment group compared to the control .


To compare the effects of ultrasonography with laparoscopy on transcervical resection of septa ( TCRS ) .


The study included @ patients with uterine septum at the present hospital between January @ and August @ that were randomly divided into two groups .


Seventy patients had TCRS monitored by ultrasound ( ultrasound group ) while @ patients were monitored by laparoscope ( laparoscope group ) .


Both groups were followed up for six to @ months .


The intraoperative status , short-term and long-term complications after operation , and pregnancy outcome of two groups were compared .


The operations of both groups were successfully completed .


The operating time , the first time to get out of bed , postoperative @hNRS ( numeric rating scale ) values , postoperative hospital stay , and the incidence of postoperative septum residue of ultrasound group were significantly less than laparoscope group ( p < @ ) .


No statistical differences were observed in intraoperative complications and pregnancy ratio between the two groups .


Both ultrasound and laparoscope monitored TCRS were safe and effective in the treatment of uterine septum .


Ultrasound monitored TCRS was more simple , economical , accurate , and non-invasive .


For patients without abnormal lesions in pelvic cavity , the present authors tend to choose the ultrasound monitored TCRS .


To investigate the cost-effectiveness of a rapid response team ( RRT ) , compared with usual care ( UC ) , for treating suicidal adolescents .


Suicidal adolescents ( n = @ ) presenting at an emergency department were enrolled in a trial to compare UC with enhanced outpatient care provided by an RRT of health professionals .


Functioning ( Child Global Assessment Scale ) and suicidality ( Spectrum of Suicidal Behavior Scale ) scores were measured at baseline and @ months later .


Resource use and cost data were collected from several sources during the same period .


As previously reported , there was no statistically or clinically significant difference in either functioning or suicidality between the groups .


Costs of the RRT were lower by $ @ , thus - $ @ ( @ % CI - $ @ to $ @ ) , from the perspective of the treating hospital , and by $ @ , thus - $ @ ( @ % CI - $ @ to $ @ ) , from the perspective of society .


If decision makers are not willing to pay for any improvement in functioning or suicidality , the RRT has a @ % probability of being cost-effective from the perspective of the treating hospital .


From the point of view of society , the probability of the intervention being cost-effective is about @ % for functioning and @ % for suicidality .


The difference between the @ perspectives is mainly attributable to the cost of hospitalizations outside the treating hospital .


An RRT intervention appears to be cost-effective , compared with UC , from the point of view of the treating hospital , but there is no difference from the point of view of society .


The cardio-renal syndrome plays a critical role in acute heart failure ( HF ) .


Levosimendan , an inodilator drug , has a positive but controversial effect on kidney .


Our aim was to evaluate its effects on both renal and systemic haemodynamic parameters as well as on renal function , explaining the possible mechanisms involved .


Patients with acute decompensated HF , moderate renal impairment , wedge pressure > @mmHg and EF < @ % were eligible .


Twenty-one patients were randomized to infusion of levosimendan or placebo , on top of standard therapy .


Systemic haemodynamic parameters ( wedge and cardiac output ) were evaluated at baseline and at @ , @ , @ , @ , and @h .


An intravascular renal artery Doppler exam was performed at baseline , after levosimendan bolus , and @h thereafter .


Renal blood flow , glomerular filtration rate ( GFR ) , cystatin C , blood urea nitrogen ( BUN ) , urinary output , sodium excretion , and plasma sodium were measured .


The effect of levosimendan was beneficial and significantly different from placebo on several renal and cardiac parameters .


Specifically , the levosimendan and placebo group exhibited significantly different changes over time in GFR ( P = @ ) , renal blood flow ( P = @ ) , and renal artery diameter ( P = @ ) , with ensuing improvements in serum levels of BUN ( P = @ ) , creatinine ( P = @ ) , and cystatin C ( P = @ ) .


Concomitantly , levosimendan provided a significant increase in urine output up to @h ( P = @ ) .


These beneficial results on renal parameters were accompanied by similarly significant and favourable changes in cardiac index ( P = @ ) and PCWP ( P < @ ) .


Levosimendan , in acute decompensated HF , has an immediate renoprotective effect , mediated by an increase in renal blood flow , due to a selective renal arterial and venous vasodilating action .


To compare the efficacy between elongated needle therapy and regular needle therapy at Tiantu ( CV @ ) on the basis of xingnao kaiqiao ( activiting brain and regaining consciousness ) acupuncture therapy so as to explore the effective therapeutic method in treatment of dysphagia induced by bulbar palsy .


Seventy one cases of dysphagia induced by bulbar palsy were randomized into two groups .


The xingnao kaiqiao acupuncture therapy was applied at Shuigou ( GV @ ) , Neiguan ( PC @ ) , Sanyinjiao ( SP @ ) and the others in the two groups .


In the elongated needle therapy group , on the basis of xingnao kaiqiao acupuncture therapy , the elongated needle was used to puncture Tiantu ( CV @ ) .


In the regular needle therapy , the regular acupuncture technique was used at Tiantu ( CV @ ) .


In both groups , the treatment was given once a day in a week except Sunday and lasted for @ weeks totally .


Before and after treatment , the swallowing condition and the standardized swallowing assessment ( SSA ) were observed in the patients and the efficacy was compared between the two groups .


The total effective rate was @ % ( @/@ ) in the elongated needle therapy group , which was better than @ % ( @/@ ) in the regular needle therapy group ( P < @ ) .


After treatment , SSA score was reduced significantly as compared with that before treatment in the two groups ( both P < @ ) .


SSA score in the elongated needle therapy group was reduced much more apparently as compared with that in the regular needle therapy group after treatment ( P < @ ) .


On the basis of the xingnao kaiqiao acupuncture therapy , the elongated needle therapy at Tiantu ( CV @ ) achieves the superior effect on bulbar palsy-induced dysphagia as compared with the regular acu - puncture at Tiantu ( CV @ ) .


Botulinum toxin Type A ( BoNT A ) for the treatment of facial wrinkles is delivered through local injection .


We previously demonstrated that topical surface application of BoNT A has negligible cutaneous bioavailability and is not effective in treating wrinkles .


To determine the effect of BoNT A solution applied topically on the skin surface immediately after ablative fractional CO@ laser treatment .


We conducted a randomized controlled trial for patients with periorbital wrinkles ( crow 's feet ) ( n = @ ) .


Treatment was performed on both sides of the face with fractional ablative CO@ laser followed by the application of topical solutions of BoNT A on one side and normal saline as control on the other side .


Pretreatment assessment was performed , and at @ and @ weeks after treatment .


There was a clinically significant greater degree of improvement in wrinkles after treatment with CO@ laser , on the topically applied BoNT A side .


Also , the difference between the @ treatment types ( laser followed by topical BoNT A vs laser followed by saline ) at @ week and at @ month was statistically significant .


Topically , noninjectable form of BoNT A applied on the surface of the skin after ablative fractional CO@ laser is effective in the treatment of lateral periorbital wrinkles .


To evaluate the incidence of surgical site infection ( SSI ) based on the type of scalpel used for incisions in the skin and in subcutaneous tissues .


Observer-blind , randomized equivalence clinical trial with two arms ( electrocautery versus conventional scalpel ) which evaluated @ women undergoing elective abdominal gynecologic oncology surgery .


A simple randomization stratified by body mass index ( BMI : @ kg/m ( @ ) ) was carried out .


Women were evaluated at @ and @ days following the operation .


A multivariate analysis was performed in order to check whether the type of scalpel would be a risk factor for SSI .


Group arms were balanced for all variables , excepted for surgical time , which was significantly higher in the electrocautery group ( mean : @ versus @ min , P = @ ) .


The rates of SSI were @ % and @ % , respectively , for the conventional scalpel and electrocautery groups ( P = @ ) .


The exploratory multivariate model identified body mass index @ kg/m ( @ ) ( OR = @ , @ % CI : @-@ @ ) and transverse surgical incision ( OR = @ , @ % CI : @-@ @ ) as independent risk factors for SSI .


The type of scalpel used in surgery , when adjusted for these variables and the surgery time , was not a risk factor for SSI .


This study showed that the SSI rates for conventional scalpel and electrocautery were not significantly different .


These results were consistent with others reported in the literature and would not allow a surgeon to justify scalpel choice based on SSI .


Photophobia and phonophobia are the most prominent symptoms in patients with migraine without aura .


Hypersensitivity to visual stimuli can lead to greater hypersensitivity to auditory stimuli , which suggests that the interaction between visual and auditory stimuli may play an important role in the pathogenesis of migraine .


However , audiovisual temporal interactions in migraine have not been well studied .


Therefore , our aim was to examine auditory and visual interactions in migraine .


In this study , visual , auditory , and audiovisual stimuli with different temporal intervals between the visual and auditory stimuli were randomly presented to the left or right hemispace .


During this time , the participants were asked to respond promptly to target stimuli .


We used cumulative distribution functions to analyze the response times as a measure of audiovisual integration .


Our results showed that audiovisual integration was significantly elevated in the migraineurs compared with the normal controls ( p < @ ) ; however , audiovisual suppression was weaker in the migraineurs compared with the normal controls ( p < @ ) .


Our findings further objectively support the notion that migraineurs without aura are hypersensitive to external visual and auditory stimuli .


Our study offers a new quantitative and objective method to evaluate hypersensitivity to audio-visual stimuli in patients with migraine .


To evaluate whether chloroquine ( CQ ) is more effective than meloxicam for treating early musculoskeletal pain and arthritis following acute chikungunya ( CHIK ) virus infection .


During the @ CHIK epidemic , @ rural community cases of acute CHIK virus infection were identified in the district of Sholapur in India .


Seventy consenting adult patients ( seropositive for IgM/IgG anti-CHIK antibody ) with early persistent musculoskeletal pain and arthritis were randomized into a @-week , @-arm , parallel efficacy trial of CQ ( @ mg/day ) and meloxicam ( @ mg/day ) .


Assessors completed a rheumatology evaluation in a blinded manner and collected blood samples in the patients ' homes , as per protocol .


Laboratory parameters included serum cytokine assay ( interleukin-@ -LSB- IL-@ -RSB- , interferon - -LSB- IFN -RSB- , tumor necrosis factor , CXCL@/IFN-inducible protein @ , and IL-@ ) .


Twenty-two patients who failed to meet the eligibility criteria ( low pain cohort ) were also followed up with similar evaluations .


An intent-to-treat analysis was completed .


At baseline , the @ groups ( @ patients randomized to receive CQ and @ patients randomized to receive meloxicam ) were well matched .


There were no significant efficacy differences between the meloxicam group and the CQ group ( mean changes in the visual analog scale score for pain -@ and -@ , respectively ) .


Patients improved significantly .


Cytokine levels remained several-fold increased , were disproportionate to the clinical response , and were not different from those in the low pain cohort .


Seven patients withdrew .


Adverse events were mild and infrequent .


This exploratory community intervention trial failed to identify an advantage of CQ over meloxicam to treat early musculoskeletal pain and arthritis following acute CHIK virus infection , but therapeutic efficacy of CQ was not ruled out .


The inflammatory cytokine response was intense and was not consistent with clinical status .


This study investigated the impact of early enteral nutrition ( EEN ) on the clinical outcomes of gastric cancer patients after radical gastrectomy .


Four hundred gastric cancer patients undergoing radical gastrectomy of any extend with D@ nodal dissection were randomly divided into an experimental and a control group with @ cases in each group .


Patients in the control group received postoperative parenteral nutrition ( PN ) , while patients in the experimental group received postoperative EEN .


After treatment , the clinical outcomes , postoperative immune function , and nutritional status of the two groups were evaluated .


The postoperative fever time , intestinal function recovery time , anal exhaust time , and the length of hospital stay for patients in the experimental group were significantly shorter than those of the control group .


We did not find significant differences in anastomotic leak , postoperative ileus and regurgitation between the two groups .


The activities of multiple immune cell types , including CD@ , CD@ , CD@/CD@ , and natural killer ( NK ) cells , were significantly lower in both groups on postoperative day @ when compared with the preoperative levels ( p < @ ) .


The level of CD@ was not significantly different between the two groups ( p > @ ) .


After treatment , levels of CD@ , CD@ , CD@/CD@ , and NK cells in the experimental group patients were @ @ , @ @ , @ @ , and @ @ % , respectively , on postoperative day @ , which were similar to the preoperative levels .


The immune cell levels from the control group patients remained significantly lower when compared with preoperative values ; in addition , these values were also significantly lower when compared with the EEN patients ( p < @ ) CONCLUSION : For gastric cancer patients undergoing radical gastrectomy , the clinical outcome , immune function and nutritional status after EEN were significantly improved .


These data suggest the widespread use of EEN in clinical practice .


Severe mentally ill ( SMI ) patients have a reduced life expectancy of @-@ years compared to the general population , largely due to an increased risk of cardiovascular mortality .


Unhealthy lifestyle behaviours in SMI patients contribute to this increased risk .


The obesogenic living environment of patients in residential facilities may even pose an extra risk .


Although several studies have shown positive effects of lifestyle interventions on SMI patients ' weight status , studies including residential patients and their obesogenic environment are scarce .


This paper describes the Effectiveness of Lifestyle Interventions in PSychiatry trial ( ELIPS ) .


The goal of this trial is to improve cardiometabolic health in severe mentally ill residential patients by addressing the obesogenic environment .


The ELIPS study is a multi-site cluster randomised controlled trial ( RCT ) based on the principles of a pragmatic RCT .


All residential and long-term clinical care teams of two large mental health care organisations in the North of the Netherlands serving SMI patients are invited to participate .


The intervention is aimed at team level .


Lifestyle coaches first develop a team specific lifestyle plan that tailors the ELIPS goals and protocol and then train teams on how to create a healthy environment and stimulate healthy behaviours in patients .


After three months , teams take over the intervention after they have set out goals to achieve in the following nine months .


In this phase , adherence to the lifestyle plan and pre-set goals is monitored .


Patients in the control arm receive care as usual .


Primary outcome measure is waist circumference at three and @months after baseline .


ELIPS is different from previously published lifestyle intervention studies in three ways .


First , it follows the principles of a pragmatic design , which enables the examination of effects in everyday practice .


Second , by implementing the intervention at team level , we expect lifestyle activities to be maintained when interventionists leave .


Last , by targeting the obesogenic environment we create a prerequisite for any sustainable health improvement , as patients can only make healthy choices in a healthy living environment .


Crotalidae Polyvalent Immune Fab ( Ovine ) has been the only antivenom commercially available in the US since @ for treatment of Crotalinae envenomation .


Late coagulopathy can occur or recur after clearance of Fab antivenom , often after hospital discharge , lasting in some cases more than @ weeks .


There have been serious , even fatal , bleeding complications associated with recurrence phenomena .


Frequent follow-up is required , and additional intervention or hospitalization is often necessary .


F ( ab ' ) @ immunoglobulin derivatives have longer plasma half life than do Fab .


We hypothesized that F ( ab ' ) @ antivenom would be superior to Fab in the prevention of late coagulopathy following treatment of patients with Crotalinae envenomation .


We conducted a prospective , double-blind , randomized clinical trial , comparing late coagulopathy in snakebitten patients treated with F ( ab ' ) @ with maintenance doses -LSB- F ( ab ' ) @/F ( ab ' ) @ -RSB- , or F ( ab ' ) @ with placebo maintenance doses -LSB- F ( ab ' ) @/placebo -RSB- , versus Fab with maintenance doses -LSB- Fab/Fab -RSB- .


The primary efficacy endpoint was coagulopathy ( platelet count < @ K/mm ( @ ) , fibrinogen level < @ mg/dL ) between end of maintenance dosing and day @ .


@ patients were randomized at @ clinical sites and received at least one dose of study drug .


@ completed the study .


Of these , @/@ ( @ % ) in the Fab/Fab cohort experienced late coagulopathy versus @/@ ( @ % , p < @ ) in the F ( ab ' ) @/F ( ab ' ) @ cohort and @/@ ( @ % , p < @ ) in the F ( ab ' ) @/placebo cohort .


The lowest heterologous protein exposure was with F ( ab ' ) @/placebo .


No serious adverse events were related to study drug .


In each study arm , one patient experienced an acute serum reaction and one experienced serum sickness .


In this study , management of coagulopathic Crotalinae envenomation with longer-half-life F ( ab ' ) @ antivenom , with or without maintenance dosing , reduced the risk of subacute coagulopathy and bleeding following treatment of envenomation .


Efficacy of the conventional - versus high-dose vancomycin regimen in patients with acute bacterial meningitis was compared .


In a randomized clinical trial @ patients with acute bacterial meningitis were randomly assigned to the conventional - or high-dose vancomycin groups .


Clinical and laboratory parameters were used for evaluation of response to the treatment regimens .


In the high-dose group , leukocytosis and fever resolved significantly faster than those in the conventional group .


Furthermore , the length of hospitalization was shorter and Glasgow Coma Scale at the end of @th day was significantly lower in the high dose compared to the conventional group .


Trend of creatinine clearance changes did not differ significantly between the two groups .


In comparison to the conventional-dose regimen , the high-dose vancomycin regimen was associated with significantly more favorable clinical response without increase in the incidence of nephrotoxicity in patients with acute bacterial meningitis .


Cushing 's disease ( CD ) can significantly impair patients ' health-related quality of life ( HRQOL ) .


This study investigated the treatment effectiveness of pasireotide on HRQOL of CD patients , and assessed the relationships between HRQOL and urinary free cortisol ( UFC ) and CD-related signs and symptoms .


In this phase III , randomized , double-blind study , patients with UFC @ upper limit of normal ( ULN ) received s.c. pasireotide @ or @g twice daily .


The trial primary endpoint was UFC at or below ULN at month @ without dose titration .


Open-label treatment continued through month @ .


HRQOL was measured using the Cushing 's Quality of Life Questionnaire ( CushingQoL ) instrument at baseline and follow-up visits until month @ during which clinical signs and features of CD , and the Beck Depression Inventory II ( BDI-II ) , were also collected .


Pearson 's / Spearman 's correlations between changes in CushingQoL and changes in clinical signs and symptoms were assessed .


Changes in CushingQoL and the proportion of patients achieving a clinically meaningful improvement in CushingQoL were also compared among patients stratified by mean UFC ( mUFC ) control status ( controlled , partially controlled , and uncontrolled ) at month @ .


Analyses were also conducted at month @ , with multivariable adjustment for baseline characteristics and CushingQoL .


Change in CushingQoL was significantly correlated with changes in mUFC ( r = -@ ) , BMI ( r = -@ ) , weight ( r = -@ ) , and BDI-II ( r = -@ ) at month @ but not at month @ .


The percentage of CushingQoL responders at month @ based on month @ mUFC control status were as follows : @ , @ , and @ % in the controlled , partially controlled , and uncontrolled groups respectively .


Adjusted CushingQoL scores at month @ were @ for controlled patients ( = @ vs uncontrolled , P = @ ) and @ for partially controlled patients ( = @ vs uncontrolled , P = @ ) .


Pasireotide treatment can result in a meaningful HRQOL improvement among those who complete a @-month treatment period , most often among patients achieving biochemical control .


Prenatal maternal stress is associated with adverse birth outcomes .


Relaxation techniques might be effective in reducing stress during that period .


The purpose of this study was to evaluate the effects of applied relaxation in reducing anxiety and stress in pregnant women in their second trimester , as well as raising their sense of control .


Also we expected to see a difference in some lifestyle factors associated with stress .


A randomized control trial with a prospective pretest-posttest experimental design was used .


Sixty primigravida women in their second trimester were assigned randomly to receive a @-week stress management programme ( N = @ ) ( relaxation breathing and progressive muscle relaxation , RB-PMR , twice a day ) or not ( N = @ ) .


Self-reported validated measures were used to evaluate perceived stress , health locus of control and anxiety at baseline and at the end of the @-weeks follow-up .


The results of the study demonstrated significant benefits from the use of the techniques in the psychological state of the pregnant women .


The systematic implementation of the proposed relaxation techniques contributed in the reduction of perceived stress ( mean change -@ , @ % CI : -@ to -@ ) and increased the sense of control ( mean change @ , @ % CI : @-@ @ ) .


The findings suggest beneficial effects of relaxation on reducing perceived stress as well as increment of sense of control in pregnant women .


The results of this study support the claim that training in the proposed relaxation techniques may constitute an ideal , non-pharmaceutical , intervention that can promote well-being , at least during pregnancy .


Longer studies will be necessary in the future , in order to examine the long-term effects of relaxation techniques .


This study examined mediators and moderators of short-term treatment effectiveness from the iQUITT Study ( Quit Using Internet and Telephone Treatment ) , a @-arm randomized trial that compared an interactive smoking cessation Web site with an online social network ( enhanced Internet ) alone and in conjunction with proactive telephone counseling ( enhanced Internet plus phone ) to a static Internet comparison condition ( basic Internet ) .


The analytic sample was N = @,@ participants with complete @-month data on all mediating variables .


The primary outcome was @-day point prevalence abstinence ( ppa ) at @ months .


Recognizing the importance of temporal precedence in mediation analyses , we also present findings for @-month outcomes .


Purported mediators were treatment utilization and changes in psychosocial constructs .


Proposed moderators included baseline demographic , smoking , and psychosocial variables .


Mediation analyses examined the extent to which between-arm differences in @-day ppa could be attributed to differential Web site utilization , telephone counseling , and associated changes in smoking self-efficacy and social support for quitting .


Effect modification analyses fitted interactions between treatment and prespecified moderators on abstinence .


Significant mediators of @-day ppa were changes in smoking temptations , quitting confidence , and positive and negative partner support , which were strongly associated with increased Web site utilization .


The addition of telephone counseling to an enhanced Web site further improved abstinence rates , partly via an association with increased quitting confidence .


Baseline smoking rate was the only significant moderator .


Increased treatment utilization and associated changes in several psychosocial measures yielded higher abstinence rates .


Findings validate the importance of treatment utilization , smoking self-efficacy , and social support to promote abstinence .


Ayurveda ( Indian-complimentary and alternative medicine ) is still most sought after in India and has promising potential in management of Vishada -LSB- major depressive disorder ( MDD ) -RSB- .


But , systematic research is lacking .


In this study we evaluated of influence of ayurvedic treatment ( Panchakarma and Ayushman-@ ) on psychopathology , heart rate variability ( HRV ) and endocrinal parameters in patients with major depression .


@ drug naive patients diagnosed as Vishada by ayurvedic physician and MDD according to DSM IV-TR were given ayurvedic Virechana module ( therapeutic purgation ) and were randomized into two groups .


Patients in group A ( n = @ ) received Ayushman-@A while group B ( n = @ ) received Ayushman-@B for two months and Shirodhara ( forehead-oil pouring therapy ) .


Patients were assessed with Hamilton Depression Rating Scale ( HDRS ) , Montgomery Asberg Depression Rating Scale ( MADRS ) , Heart Rate Variability ( HRV ) .


Cortisol and adrenocorticotropic hormone ( ACTH ) were estimated at baseline and after ayurvedic therapy .


HRV and endocrinal parameters were compared with age and gender matched healthy volunteers .


HRV parameters showed significant sympathetic dominance in patients compared to healthy volunteers .


Two months of ayurvedic treatment significantly decreased psychopathology , showed increase in vagal tone , decrease in sympathetic tone and reduced cortisol levels .


However , there was no significant difference between groups receiving Ayushman A and B.


This study provides evidence for antidepressant , cardiac ( HRV ) and beneficial neuroendocrine modulatory influence of Ayurveda therapy in patients of Vishada ( MDD ) .


Further studies are needed to confirm these findings .


Greater insight into the neurobiology behind this therapy might provide valuable information about newer drug target .


Gestational diabetes mellitus ( GDM ) is a risk factor for the development of type @ diabetes .


Lifestyle intervention can prevent progression to type @ diabetes in high risk populations .


We designed a randomised controlled trial ( RCT ) to evaluate the effectiveness of an established lifestyle intervention compared to standard care for delaying diabetes onset in European women with recent GDM .


Recruitment into the RCT was more challenging than anticipated with only @ of @ ( @ % ) women agreeing to participate .


This paper identifies factors that could enhance participation of the target population in future interventions .


We hypothesised that women who agreed to participate would have higher diabetes risk profiles than those who declined , and secondly that it would be possible to predict participation on the bases of those risk factors .


To test our hypothesis , we identified the subset of women for whom we had comprehensive data on diabetes risks factors @-@ years following GDM , reducing the sample to @ participants and @ decliners .


We considered established diabetes risk factors : smoking , daily fruit and vegetable intake , participation in exercise , family history of diabetes , glucose values and BMI scores on post-partum re-screens , use of insulin during pregnancy , and age at delivery .


We also analysed narrative data from @ decliners to further understand barriers to and facilitators of participation .


Two factors differentiated participants and decliners : age at delivery ( with women older than @ years being more likely to participate ) and insulin use during pregnancy ( with women requiring the use of insulin in pregnancy less likely to participate ) .


Binary logistic regression confirmed that insulin use negatively affected the odds of participation .


The most significant barriers to participation included the accessibility , affordability and practicality of the intervention .


Women with recent GDM face multiple barriers to lifestyle change .


Intervention designers should consider : ( i ) the practicalities of participation for this population , ( ii ) research designs that capitalise on motivational differences between participants , ( iii ) alleviating concerns about long-term diabetes management .


We hope this work will support future researchers in developing interventions that are more relevant , effective and successful in recruiting the desired population .


This study aimed to evaluate the effects of phyto-supplements on hyperlipidemia .


For this study @ patients , affected by hyperlipidemia , attending the Outpatient Clinics of Clinical Medicine Department , were recruited .


The patients were divided in two groups .


The first group ( @ ) has been treated with hypolipidic diet for six months ( group D ) .


The second one ( @ ) has been administered with hypolipidic diet and supplement ( red yeast , guggulsterones , flavonoid , sylimarin ) ( group E ) .


Anthropometric measurements and bioimpedance analysis were evaluated before and after treatment .


Moreover , total cholesterol , LDL , HDL , triglycerides ( TG ) and hepatic transaminases ( AST , ALT ) were measured before , after @ and @ months of treatment .


D group showed a significant reduction in BMI ( @ @ vs. @ @ kg/m ) , waist circumference ( @ @ vs. @ @ cm ) , hip circumference ( @ @ vs. @ @ cm ) , total cholesterol ( @ @ vs. @ @ mg/dL , -@ @ % ) , LDL cholesterol ( @ @ vs. @ @ mg/dL , -@ @ % ) .


E group showed a significant reduction in BMI ( @ @ vs. @ @ kg/m ) , waist circumference ( @ @ vs. @ @ cm ) , hip circumference ( @ @ vs. @ @ cm ) , total cholesterol ( @ @ vs. @ @ mg/dL , -@ @ % ) , LDL cholesterol ( @ @ vs. @ @ mg/dL , -@ @ % ) .


Low fat diet , associated to phyto-substance supplement , have been proven useful to decrease serum cholesterol level and to improve nutritional status .


Long-lasting low back pain is an increasing problem , and for some patients surgery is the final option for improvement .


Several techniques for spinal fusion are available and the optimal technique remains uncertain .


The objective of this study was to assess the cost-effectiveness and cost-utility of transforaminal lumbar interbody fusion ( TLIF ) compared to posterolateral instrumented fusion ( PLF ) from the societal perspective .


@ Patients were randomized to TLIF or PLF ( @/@ ) and followed for @years .


Cost data were acquired from national registers , and outcomes were measured using the Oswestry Disability Index and SF-@D questionnaires .


Conventional cost-effectiveness methodology was employed to estimate net benefit and to illustrate cost-effectiveness acceptability curves .


The statistical analysis was based on means and bootstrapped confidence intervals .


Results showed no statistically significant difference in either cost or effects although a tendency for the TLIF regimen being more costly on bed days ( <euro> @,@ ) and production loss ( <euro> @,@ ) was observed .


The probability that TLIF would be cost-effective did not exceed @ % for any threshold of willingness to pay per quality-adjusted life year .


Sensitivity analysis was conducted and supported the statistical model for handling of missing data .


TLIF does not seem to be a relevant alternative to PLF from a socioeconomic , societal point of view .


According to international treatment guidelines , inhaled rapid-acting @ agonists should be used for the control of symptoms in patients with asthma .


We compared the efficacy and safety of an extrafine combination inhaler containing a corticosteroid ( beclometasone ) plus a rapid-onset , long-acting @ agonist ( formoterol ) with a short-acting @ agonist ( salbutamol ) as reliever strategies in patients taking beclometasone-formoterol combination as maintenance treatment .


In a double-blind trial undertaken in @ centres in @ European countries over @ weeks , patients ( aged @ years ) with asthma that was not fully controlled , with a forced expiratory volume in @ s ( FEV@ ) of at least @ % predicted , had a @-week run in .


During this period , patients were treated with a combination of beclometasone @ g and formoterol @ g per one inhalation twice daily plus salbutamol @ g as required delivered by use of a pressurised metered-dose inhaler .


They were then randomly assigned in a @:@ ratio with a computer-generated randomisation list to receive beclometasone @ g plus formoterol @ g or salbutamol @ g as reliever in addition to maintenance with beclometasone @ g plus formoterol @ g twice daily .


Primary outcome was the time to first severe exacerbation ( admission to hospital or visit to emergency department , or use of systemic steroids for @ consecutive days ) .


Secondary outcomes were number of severe exacerbations ( events per @ patients per year ) , time to and number of mild exacerbations , additional exacerbation variables , lung function , symptom scores , and asthma control .


Analysis was by intention to treat .


The study is registered with ClinicalTrials.gov , number NCT@ .


@ patients were randomly assigned to the as-needed beclometasone-formoterol ( n = @ ) and as-needed salbutamol groups ( n = @ ) , and @ were analysed ( @ and @ , respectively ) .


@ severe exacerbations were reported by @ patients during the study , and @ versus @ patients had at least one exacerbation during the @ weeks , respectively .