The additive main effects multiplicative interactions model was used to test for a subject by diet interaction .


Differences among diets were determined using a mixed-models procedure ( PROC MIXED ) with random intercept for each subject .


Total cholesterol and low-density lipoprotein cholesterol significantly decreased on Korean ( P < @ and P < @ , respectively ) and DGA ( P < @ and P < @ , respectively ) diets , but not on the typical American diet .


Although an unfavorable outcome , high-density lipoprotein cholesterol significantly decreased on all three diets ( Korean : P < @ ; DGA : P < @ ; typical American : P < @ ) .


No diet had a significant effect on serum triglycerides , but a slight increase in triglycerides in the Korean and decrease in the DGA resulted in a significant difference between these two diets ( P < @ ) .


All three diets caused modest decreases in systolic and diastolic blood pressure , which reached statistical significance for DGA only ( P < @ and P < @ , respectively ) .


No diet had significant effect on fasting insulin , whereas fasting glucose decreased significantly on the Korean ( P < @ ) and typical American ( P < @ ) diets only .


Urinary sodium output decreased significantly on DGA ( P < @ ) .


After a @-week feeding period , Korean and DGA diet patterns resulted in positive changes in cardiovascular disease risk factors .


The primary outcome results for the SPS@ trial suggested that a lower systolic target blood pressure ( < @ mm Hg ) might be beneficial for reducing the risk of recurrent stroke compared with a higher target ( @-@ mm Hg ) , but that the addition of clopidogrel to aspirin was not beneficial compared with aspirin plus placebo .


In this prespecified secondary outcome analysis of the SPS@ trial , we aimed to assess whether blood pressure reduction and dual antiplatelet treatment affect changes in cognitive function over time in patients with cerebral small vessel disease .


In the SPS@ trial , patients with recent ( within @ months ) symptomatic lacunar infarcts from @ centres in North America , Latin America , and Spain were randomly assigned , in a two-by-two factorial design , to target levels of systolic blood pressure ( @:@ ; @-@ mm Hg vs < @ mm Hg ; open-label ) and to a once-daily antiplatelet treatment ( @:@ ; aspirin @ mg plus clopidogrel @ mg vs aspirin @ mg plus placebo ; double-blind ) .


For this analysis , the main cognitive outcome was change in Cognitive Abilities Screening Instrument ( CASI ) during follow-up .


Patients were tested annually for up to @ years , during which time the mean difference in systolic blood pressure was @ mm Hg ( SD @ ) between the two targets ( @ mm Hg vs @ mm Hg at @ year ) .


We used linear mixed models to compare changes in CASI Z scores over time .


The SPS@ trial is registered with ClinicalTrials.gov , number NCT@ .


The study took place between March @ , @ , and April @ , @ of @ SPS@ participants ( mean age @ years -LSB- SD @ -RSB- ) with CASI scores at study entry were included in the analysis , with a median follow-up of @ years ( IQR @-@ ) .


Mean changes in CASI Z scores from study entry to assessment at years @ ( n = @ ) , @ ( n = @ ) , @ ( n = @ ) , @ ( n = @ ) , and @ ( n = @ ) were @ ( SD @ ) , @ ( @ ) , @ ( @ ) , @ ( @ ) , and @ ( @ ) , respectively .


Changes in CASI Z scores over time did not differ between assigned antiplatelet groups ( p = @ ) or between assigned blood pressure target groups ( p = @ ) .


There was no interaction between assigned antiplatelet groups and assigned blood pressure target groups and change over time ( p = @ ) .


Cognitive function is not affected by short-term dual antiplatelet treatment or blood pressure reduction in fairly young patients with recent lacunar stroke .


Future studies of cognitive function after stroke should be of longer duration or focus on patients with higher rates of cognitive decline .


Vascular endothelial growth factor C ( VEGFC ) and vascular endothelial growth factor receptor @ ( VEGFR@ ) mRNA overexpression has recently been shown to have strong predictive and prognostic value in patients with high-risk early breast cancer undergoing adjuvant chemotherapy .


The present study evaluated associations of VEGFC and VEGFR@ with human epidermal growth factor receptor @ ( HER@ ) and their prognostic value dependent on HER@ status .


RNA was isolated from @ formalin-fixed paraffin-embedded tumor tissue samples from the HeCOG @/@ ( HE@/@ ) trial , evaluating adjuvant dose-dense sequential chemotherapy with epirubicin followed by cyclophosphamide , methotrexate and @-fluorouracil therapy with or without paclitaxel ( E-T-CMF vs. E-CMF ) .


A fully-automated method based on magnetic beads was applied for RNA extraction , followed by one-step quantitative reverse transcription-polymerase chain reaction .


At @ years of median follow-up , @ patients ( @ % ) had experienced relapse and @ ( @ % ) had died .


There were strong associations between VEGFC/VEGFR@ mRNA expression and HER@ and estrogen receptor/progesterone receptor status .


In multivariate analysis , both VEGFC and VEGFR@ were found to be associated with risk for death or relapse , but such associations depended on HER@ status and treatment group .


High VEGFC was a negative prognostic factor for disease-free survival -LSB- hazard ratio ( HR ) = @ , @ % confidence interval ( CI ) = @-@ @ , Wald 's p = @ -RSB- , with a trend for overall survival ( HR = @ , @ % CI = @-@ @ , p = @ ) in patients treated with E-CMF adjusted for clinicopathological characteristics , while high VEGFR@ was associated with increased risk for death , yet non significantly in patients with HER@-negative disease ( HR = @ , @ % CI = @-@ @ , p = @ ) , regardless of treatment .


VEGFC and VEGFR@ mRNA overexpression is of prognostic value , dependent on HER@ status , in patients with high-risk early breast cancer undergoing adjuvant treatment .


Among HER@-negative cases , these angiogenic markers could identify more aggressive tumors with worse prognosis .


Further studies are warranted to validate VEGFC and VEGFR@ as potential biomarkers in adjuvant therapy and their use in identifying sub-groups that could benefit from anti-VEGF strategies .


Randomized clinical study .


To compare the effects of trigger point ( TrP ) dry needling ( DN ) and TrP manual therapy ( MT ) on pain , function , pressure pain sensitivity , and cervical range of motion in subjects with chronic mechanical neck pain .


Recent evidence suggests that TrP DN could be effective in the treatment of neck pain .


However , no studies have directly compared the outcomes of TrP DN and TrP MT in this population .


Ninety-four patients ( mean SD age , @ @ years ; @ % female ) were randomized into a TrP DN group ( n = @ ) or a TrP MT group ( n = @ ) .


Neck pain intensity ( @-point numeric pain rating scale ) , cervical range of motion , and pressure pain thresholds ( PPTs ) over the spinous process of C@ were measured at baseline , postintervention , and at follow-ups of @ week and @ weeks after treatment .


The Spanish version of the Northwick Park Neck Pain Questionnaire was used to measure disability/function at baseline and the @-week follow-up .


Mixed-model , repeated-measures analyses of variance ( ANOVAs ) were used to determine if a time-by-group interaction existed on the effects of the treatment on each outcome variable , with time as the within-subject variable and group as the between-subject variable .


The ANOVA revealed that participants who received TrP DN had outcomes similar to those who received TrP MT in terms of pain , function , and cervical range of motion .


The @-by-@ mixed-model ANOVA also revealed a significant time-by-group interaction ( P < @ ) for PPT : patients who received TrP DN experienced a greater increase in PPT ( decreased pressure sensitivity ) than those who received TrP MT at all follow-up periods ( between-group differences : posttreatment , @ kPa ; @ % confidence interval -LSB- CI -RSB- : @ , @ ; @-week follow-up , @ kPa ; @ % CI : @ , @ ; @-week follow-up , @ kPa ; @ % CI : @ , @ ) .


The results of this clinical trial suggest that @ sessions of TrP DN and TrP MT resulted in similar outcomes in terms of pain , disability , and cervical range of motion .


Those in the TrP DN group experienced greater improvements in PPT over the cervical spine .


Future trials are needed to examine the effects of TrP DN and TrP MT over long-term follow-up periods .


Therapy , level @b .


To investigate the application of lactic acid in early diagnosis and goal-directed therapy of septic shock , and to provide reference for the early clinical diagnosis and treatment of septic shock .


A prospective observational study was conducted , in which patients satisfied with the criteria of septic shock diagnosis were enrolled .


The patients were randomly divided into two groups .


The lactic group was defined using blood lactic acid concentration < @ mmol/L as treatment guide target .


Control group was defined according to the traditional diagnostic criteria of shock which systolic blood pressure was less than @ mmHg ( @ mmHg = @ kPa ) or systolic blood pressure value fell > @ mmHg baseline or oliguria ( < @ ml .


kg-@ .


h-@ ) et al traditional septic shock diagnosis criteria and bundle treatment was performed .


Organ dysfunction index , the sequential organ failure score ( SOFA ) , acute physiology and chronic health evaluation score II ( APACHE II ) score , the time of mechanical ventilation , the time of stay in the intensive care unit ( ICU ) , and the @-and @-day mortality were recorded .


There were @ and @ septic shock patients in lactic group and control group respectively .


Organ dysfunction index had been improved in different degrees after treatment compared with that before treatment .


Creatinine ( Cr ) at @ hours after treatment in lactic group was significantly lower than that in control group ( mol/L : @ @ vs. @ @ , P < @ ) , and there was no statistical difference in other indexes .


The SOFA score of lactic group at @ hours and @ hours after treatment was lower than that of control group ( @ @ vs. @ @ , t = @ , P = @ ; @ @ vs. @ @ , t = @ , P = @ ) .


APACHE II score of two group after treatment were lower than that before treatment , and lactic group decreased more obviously compared with control group ( @ @ vs. @ @ , t = @ , P = @ ; @ @ vs @ @ , t = @ , P = @ ) .


The time of stay in the ICU and the time of mechanical ventilation of lactic group were shorter that those of control group , but there was no statistical difference -LSB- ICU time ( days ) : @ @ vs. @ @ , t = @ , P = @ ; mechanical ventilation time ( hours ) : @ @ vs. @ @ , t = @ , P = @ -RSB- .


There was no statistical difference regarding @-day mortality of lactic group was lower than that of control group -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , @ = @ , P = @ -RSB- .


The @-day mortality of lactic group was lower than that of control group -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) .


@ = @ , P = @ -RSB- .


By blood lactic acid monitoring , inadequacy of organization perfusion i.e. septic shock can be found in the early stage , thus early intervention can be performed and improve resuscitation result and reduce the mortality of septic shock patients .


Blood lactic acid @ mmol/L can be used as one of the criteria for the diagnosis of septic shock , and @-hour blood lactic acid < @ mmol/L as a goal to guide shock treatment with obvious prognosis improvement .


The aim of the present trial on ultrasound ( US ) - guided laser ablation therapy ( LAT ) of solid thyroid nodules is to assess long-term clinical efficacy , side effects , and predictability of outcomes in different centers operating with the same procedure .


Two hundred consecutive patients were randomly assigned to a single LAT session ( group @ , @ cases ) or to follow-up ( group @ , @ cases ) at four thyroid referral centers .


Entry criteria were : solid thyroid nodule with volume of @-@ mL , repeat benign cytological findings , normal thyroid function , no autoimmunity , and no thyroid gland treatment .


Group @ : LAT was performed in a single session with two optical fibers , a @ nm Nd-YAG laser source , and an output power of @ W. Volume and local symptom changes were evaluated @ , @ , @ , @ , and @ months after LAT .


Side effects and tolerability of treatment were registered .


Group @ : Follow-up with no treatment .


One patient was lost to follow-up in each group .


Group @ : Volume decrease after LAT was -@ @ % , -@ @ % , -@ @ % , and -@ @ % at @ , @ , @ , and @ months , respectively ( P < @ vs baseline ) .


LAT resulted in a nodule reduction of > @ % in @ % of cases ( P < @ ) .


Local symptoms decreased from @ to @ % of cases ( P = @ ) and cosmetic signs from @ to @ % of cases ( P = @ ) .


Baseline size , presence of goiter ( P = @ ) , or US findings ( fluid component @ % -LSB- P = @ -RSB- , halo -LSB- P = @ -RSB- , vascularization -LSB- P = @ -RSB- , and calcifications -LSB- P = @ -RSB- ) were not predictive factors of a volume decrease > @ % .


The procedure was well tolerated in most ( @ % ) cases .


No changes in thyroid function or autoimmunity were observed .


In group @ , nodule volume increased at @ months ( @ @ % ; P = @ ) .


The efficacy and tolerability of the procedure were similar in different centers .


A single LAT treatment of solid nodules results in significant and persistent volume reduction and local symptom improvement , in the absence of thyroid function changes .


Live attenuated influenza vaccines ( LAIVs ) are being developed to protect humans against future epidemics and pandemics .


This study describes the results of a double-blinded randomized placebo-controlled phase I clinical trial of cold-adapted and temperature sensitive H@N@ live attenuated influenza vaccine candidate in healthy seronegative adults .


The goal of the study was to evaluate the safety , tolerability , immunogenicity and potential shedding and transmission of H@N@ LAIV against H@ avian influenza virus of pandemic potential .


Two doses of H@N@ LAIV or placebo were administered to @ randomly divided subjects ( @ received vaccine and @ placebo ) .


The presence of influenza A virus RNA in nasal swabs was detected in @ % and @ % of subjects after the first and second vaccination , respectively .


In addition , vaccine virus was not detected among placebo recipients demonstrating the absence of person-to-person transmission .


The H@N@ live attenuated influenza vaccine demonstrated a good safety profile and was well tolerated .


The two-dose immunization resulted in measurable serum and local antibody production and in generation of antigen-specific CD@ and CD@ memory T cells .


Composite analysis of the immune response which included hemagglutinin inhibition assay , microneutralization tests , and measures of IgG and IgA and virus-specific T cells showed that the majority ( @ % ) of vaccine recipients developed serum and/or local antibodies responses and generated CD@ and CD@ memory T cells .


The H@N@ LAIV was safe and well tolerated , immunogenic in healthy seronegative adults and elicited production of antibodies broadly reactive against the newly emerged H@N@ avian influenza virus .


Galectin-@ ( Gal-@ ) is a marker of myocardial fibrosis , and elevated levels are associated with adverse outcomes .


Mineralocorticoid receptor antagonists ( MRAs ) modulate cardiac fibrosis in heart failure ( HF ) patients and have been shown to improve long-term outcomes .


We examined whether treatment effects from MRA use differed by Gal-@ levels in ambulatory heart failure patients enrolled in HF-ACTION .


HF-ACTION was a randomized controlled trial of exercise training versus usual care in patients with HF due to LV systolic dysfunction ( New York Heart Association functional class II-IV , left ventricular ejection fraction @ , median follow-up @ years ) .


Galectin-@ was assessed at baseline in @ patients .


The end point was all-cause mortality or all-cause hospitalization ( ACM+ACH ) ; all-cause mortality ( ACM ) was a key secondary end point .


A differential association of MRA use by increasing Gal-@ concentration was tested with the use of interaction terms in Cox proportional hazards models , adjusted for covariates previously identified in this cohort as well as age , sex , and race .


Inverse propensity-weighted ( IPW ) methods were also used to assess this association .


Approximately one-half ( n = @ ) of the patients were on an MRA .


There was no significant interaction for the associations of Gal-@ levels and MRA use for either end point ( adjusted interaction P = @ for ACM+ACH ; P = @ for ACM ) .


There was no evidence of improved outcomes for patients on an MRA compared with those not on MRA for either end point ( hazard ratio -LSB- HR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ , P = @ ; and HR = @ , @ % CI -LSB- @-@ @ -RSB- , P = @ ; respectively ) .


IPW analysis was consistent with the results of the adjusted analysis .


Our study showed no evidence of interaction between Gal-@ and treatment effect of MRA .


Whether biomarkers may be used to predict which patients may benefit from an mineralocorticoid receptor antagonist in HF requires further investigation .


This study investigated the effects of written emotional disclosure on a model of chronic pain in healthy women with and without trauma history .


Participants were prescreened for their trauma history ( N = @ ) and randomized to a disclosure or a control writing condition .


Pain testing occurred either @ day or @ month after disclosure .


Capsaicin was applied to the forearm to evoke spontaneous burning pain at the application site and mechanical secondary hyperalgesia in the surrounding untreated skin .


As hypothesized , the effect of disclosure on the area and intensity of secondary hyperalgesia depended on trauma history and time of testing ( F ( @,@ ) @ , p = @ ) .


Disclosure increased secondary hyperalgesia in participants with trauma history compared with those without trauma when testing occurred @ day after writing ( F ( @,@ ) @ , p @ ) , whereas the opposite pattern was observed @ month later ( F ( @,@ ) @ , p @ ) .


Of the participants with trauma history in the disclosure condition , secondary hyperalgesia was reduced at @ month compared with @ day after writing ( p = @ ) .


Moreover , greater use of positive emotional words predicted reduced secondary hyperalgesia at @ month ( = -@ , p = @ ) .


In contrast , disclosure had no effect on spontaneous pain .


Disclosure modulates secondary hyperalgesia observed in women with trauma history , producing a short-term enhancement and a long-term reduction .


This suggests that disclosure has a long-term protective effect that reduces sensitization of pain , which may explain the therapeutic effects of disclosure in patients with chronic pain .


With recent progress in health science administration , a huge amount of data has been collected from thousands of subjects .


Statistical and computational techniques are very necessary to understand such data and to make valid scientific conclusions .


The purpose of this paper was to develop a statistical probability model and to predict future survival times for male breast cancer patients who were diagnosed in the USA during @-@ .


A random sample of @ male patients was selected from the Surveillance Epidemiology and End Results ( SEER ) database .


The survival times for the male patients were used to derive the statistical probability model .


To measure the goodness of fit tests , the model building criterions : Akaike Information Criteria ( AIC ) , Bayesian Information Criteria ( BIC ) , and Deviance Information Criteria ( DIC ) were employed .


A novel Bayesian method was used to derive the posterior density function for the parameters and the predictive inference for future survival times from the exponentiated Weibull model , assuming that the observed breast cancer survival data follow such type of model .


The Markov chain Monte Carlo method was used to determine the inference for the parameters .


The summary results of certain demographic and socio-economic variables are reported .


It was found that the exponentiated Weibull model fits the male survival data .


Statistical inferences of the posterior parameters are presented .


Mean predictive survival times , @ % predictive intervals , predictive skewness and kurtosis were obtained .


The findings will hopefully be useful in treatment planning , healthcare resource allocation , and may motivate future research on breast cancer related survival issues .


The effect of levosimendan on renal function in patients with low ejection fraction undergoing mitral valve surgery was investigated .


A prospective , double-blinded , randomized clinical trial .


Tertiary teaching and research hospital .


Of a total of @ patients , @ patients completed the study .


In the levosimendan group ( n = @ ) , levosimendan was administered in addition to standard inotropic support ; whereas , in the control group ( n = @ ) , only standard inotropic support was given .


In the levosimendan group , a loading dose of levosimendan ( @ g/kg ) was administered after removal of the aortic cross-clamp , followed by an infusion ( @ g/kg/min ) in addition to standard inotropic therapy for @ hours .


In the control group , only standard inotropic therapy was administered .


Preoperative characteristics , serum creatinine ( sCr ) levels , and estimated glomerular filtration rate ( eGFR ) were determined preoperatively , on postoperative days @ , @ , and @ .


Independent risk factors for renal replacement therapy ( RRT ) requirement were investigated with stepwise multivariate logistic regression analysis .


The primary endpoint was the effect of levosimendan on postoperative renal clearance ( sCr and eGFR ) .


The secondary endpoint was the effect of levosimendan on clinical outcomes ( length of intensive care unit and hospital stays , need for RRT ) .


Preoperative characteristics and eGFR were similar between the groups ( p > @ ) .


On postoperative days @ and @ , sCr values were lower and eGFR values were higher in the levosimendan group in comparison with the control group ( p = @ , p = @ , respectively ) .


Six patients ( @ % ) in the levosimendan group and @ patients ( @ % ) in the control group required RRT therapy ( p = @ ) .


Independent risk factors for need of RRT include preoperative sCr value between @ to @ mg/dL and@ @ mg/dL ( p < @ ) .


Perioperative treatment with levosimendan in addition to standard inotropic therapy in patients with a low ejection fraction undergoing mitral valve surgery improved immediate postoperative renal function and reduced need for RRT .


We have previously reported that radiotherapy ( RT ) added to androgen-deprivation therapy ( ADT ) improves survival in men with locally advanced prostate cancer .


Here , we report the prespecified final analysis of this randomized trial .


NCIC Clinical Trials Group PR @ / Medical Research Council PR@/Intergroup T@-@ was a randomized controlled trial of patients with locally advanced prostate cancer .


Patients with T@-@ , N@/Nx , M@ prostate cancer or T@-@ disease with either prostate-specific antigen ( PSA ) of more than @ g/L or PSA of @ to @ g/L plus Gleason score of @ to @ were randomly assigned to lifelong ADT alone or to ADT+RT .


The RT dose was @ to @ Gy in @ to @ fractions to the prostate and pelvis or prostate alone .


Overall survival was compared using a log-rank test stratified for prespecified variables .


One thousand two hundred five patients were randomly assigned between @ and @ , @ to ADT alone and @ to ADT+RT .


At a median follow-up time of @ years , @ patients had died , including @ patients from prostate cancer .


Overall survival was significantly improved in the patients allocated to ADT+RT ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ; P < @ ) .


Deaths from prostate cancer were significantly reduced by the addition of RT to ADT ( HR , @ ; @ % CI , @ to @ ; P < @ ) .


Patients on ADT+RT reported a higher frequency of adverse events related to bowel toxicity , but only two of @ patients had grade @ or greater diarrhea at @ months after RT. .


This analysis demonstrates that the previously reported benefit in survival is maintained at a median follow-up of @ years and firmly establishes the role of RT in the treatment of men with locally advanced prostate cancer .


Smoking prevalence rates among Dutch children increase rapidly after they transit to secondary school , in particular among children with a low socioeconomic status ( SES ) .


Web-based , computer-tailored programs supplemented with prompt messages may be able to empower children to prevent them from starting to smoke when they transit to secondary school .


The main aim of this study is to evaluate whether computer-tailored feedback messages , with and without prompt messages , are effective in decreasing children 's smoking intentions and smoking behavior after @ and @ months of follow-up .


Data were gathered at baseline ( T@ ) , and after @ months ( T@ ) and @ months ( T@ ) of follow-up of a smoking prevention intervention program called Fun without Smokes .


A total of @ schools were randomly allocated to a no-intervention control group , an intervention prompt group , or an intervention no-prompt group .


A total of @ children aged @ to @ years old participated in the study and completed a Web-based questionnaire assessing their smoking intention , smoking behavior , and sociocognitive factors , such as attitude , social influence , and self-efficacy , related to smoking .


After completion , children in the intervention groups received computer-tailored feedback messages in their own email inbox and those messages could be accessed on the intervention website .


Children in the prompt group received prompt messages , via email and short message service ( SMS ) text messaging , to stimulate them to reuse the intervention website with nonsmoking content .


Multilevel logistic regression analyses were performed using multiple imputations to assess the program effects on smoking intention and smoking behavior at T@ and T@ .


A total of @ children participated in the Fun without Smokes study at T@ .


Between T@ and T@ a total of @ children out of the original @ ( @ % ) dropped out of the study .


Between T@ and T@ the number of children that did not participate in the final measurement was @ out of the original @ ( @ % ) .


No significant program effects were observed for any of the intervention groups compared to the control group at T@ for the intention to engage in smoking-prompt , OR @ ( @ % CI @-@ @ ) , no-prompt , OR @ ( @ % CI @-@ @ ) - or for smoking behavior-prompt , OR @ ( @ % CI @-@ @ ) , no-prompt , OR @ ( @ % CI @-@ @ ) .


Similar nonsignificant program effects were found at T@ for the intention to start smoking-prompt , OR @ ( @ % CI @-@ @ ) , no-prompt , OR @ ( @ % CI @-@ @ ) - and smoking behavior-prompt , OR @ ( @ % CI @-@ @ ) , no-prompt , OR @ ( @ % CI @-@ @ ) .


This study showed that the Web-based , computer-tailored feedback messages with and without prompt messages were not effective in modifying children 's smoking intentions and smoking behavior as compared to no information .


Future smoking prevention interventions are recommended to start closer to the age of actual smoking uptake .


Furthermore , future studies on Web-based , computer-tailored smoking prevention programs should focus on assessing and controlling exposure to the educational content and the response to the prompt messages .


Routine resection of cavity shave margins ( additional tissue circumferentially around the cavity left by partial mastectomy ) may reduce the rates of positive margins ( margins positive for tumor ) and reexcision among patients undergoing partial mastectomy for breast cancer .


In this randomized , controlled trial , we assigned , in a @:@ ratio , @ patients with breast cancer of stage @ to III who were undergoing partial mastectomy , with or without resection of selective margins , to have further cavity shave margins resected ( shave group ) or not to have further cavity shave margins resected ( no-shave group ) .


Randomization occurred intraoperatively after surgeons had completed standard partial mastectomy .


Positive margins were defined as tumor touching the edge of the specimen that was removed in the case of invasive cancer and tumor that was within @ mm of the edge of the specimen removed in the case of ductal carcinoma in situ .


The rate of positive margins was the primary outcome measure ; secondary outcome measures included cosmesis and the volume of tissue resected .


The median age of the patients was @ years ( range , @ to @ ) .


On final pathological testing , @ patients ( @ % ) had invasive cancer , @ ( @ % ) had ductal carcinoma in situ , and @ ( @ % ) had both ; @ patients had no further disease .


The median size of the tumor in the greatest diameter was @ cm ( range , @ to @ ) in patients with invasive carcinoma and @ cm ( range , @ to @ ) in patients with ductal carcinoma in situ .


Groups were well matched at baseline with respect to demographic and clinicopathological characteristics .


The rate of positive margins after partial mastectomy ( before randomization ) was similar in the shave group and the no-shave group ( @ % and @ % , respectively ; P = @ ) .


After randomization , patients in the shave group had a significantly lower rate of positive margins than did those in the no-shave group ( @ % vs. @ % , P = @ ) , as well as a lower rate of second surgery for margin clearance ( @ % vs. @ % , P = @ ) .


There was no significant difference in complications between the two groups .


Cavity shaving halved the rates of positive margins and reexcision among patients with partial mastectomy .


( Funded by the Yale Cancer Center ; ClinicalTrials.gov number , NCT@ . )


Nuclear and cytoplasmic competence of human oocyte is critical for future competence of the embryo upon which ultimately depends the outcome of an ART ( Assisted Reproductive Technology ) treatment .


Follicular microenvironment in which the oocyte develops is crucial , and this must be taken into account particularly with the use of hormonal ovarian stimulation protocols .


Inositol is an important element of the follicular environment and data support that its higher level in follicular fluid correlates with the development of a good oocyte .


Aim of this study is to understand the effects of treatment with inositol on oocyte quality in a sample of patients undergoing ICSI ( Intracytoplasmic Sperm Injection ) .


Assessment of oocyte/embryo quality and pregnancy rates in @ patients divided , according to a controlled randomized pattern , into two groups : study group @ treated with folic acid and inositol and control group @ treated with folic acid alone .


The number of patients with excellent and good oocyte quality appears to be significantly higher in group @ ( p = @ ) , as shown , they significantly increased the number of embryos of grade A transferred in the group @ ( p = @ ) compared to group @ , despite being completely similar averages of total embryos transferred ( total mean SD = @ @ , group @ mean SD = @ @ , group @ mean SD = @ @ ) .


There is not any significant difference between groups @ and @ in the number of positivity to - hCG and in the number of biochemical pregnancies detected although it has a tendency to increase in the first and to decrease in the second for group @ .


The increase in percentage of clinical pregnancies in group @ was statistically significant ( p = @ ) , whereas there was no apparent significance in the difference between the biochemical and clinical pregnancies in the two groups despite the positive trend in the study group .


Relying on `` inositol help '' to solidify our efforts , seems to be an easy path to help to deepen the effectiveness of its use in all patients still under @ but with prior failed attempts at ICSI or diagnosed with PCOS or as `` poor responders '' .


Unsedated transnasal upper endoscopy ( TNE ) has been suggested as a more comfortable and safer method than unsedated transoral endoscopy ( TOE ) .


However , the numbers of comparative trials are limited .


The current study aimed to assess the tolerability , safety , and efficacy of TNE in endoscopy nave patients .


The current study was designed as a randomized , prospective , parallel arm trial including all eligible patients referred for upper endoscopy .


Patients were randomized with a @:@ ratio to undergo either unsedated TOE using a standard endoscope or unsedated TNE using an ultrathin endoscope .


Postprocedure , all patients were asked to complete a questionnaire to assess pain , discomfort , distress and tolerability using a @ cm visual analog scale ( VAS ) .


Patients ' expectations and future preferences were also determined by multiple choice questions .


Endoscope insertion rate , procedure duration , and side-effects were recorded for each patient .


Each group included @ patients .


With the exception of nasal pain , mean VAS scores were significantly lower in TNE patients when compared to TOE patients ( p = @ ) .


@ % and @ % of patients in TNE and TOE groups , respectively , found the procedure better than expected ( p = @ ) .


A repeat procedure was significantly more acceptable for TNE than TOE ( @ % and @ % , respectively ) .


Endoscope insertion failed in @ % of TNE patients .


Mild epistaxis was observed in @ % of TNE patients .


Unsedated TNE was tolerated better in endoscopy naive patients than unsedated TOE in a large parallel arm trial .


Oxycodone is semi-synthetic opioid , oral and parenteral preparations have been widely used for acute and chronic pain .


The aim of this study was to assess the efficacy and side effects of oxycodone and fentanyl in patient controlled analgesia ( PCA ) after laparoscopic cholecystectomy .


A prospective , randomized , double-blind study was conducted .


@ patients were randomly divided into two groups ; fentanyl ( @ mcg fentanyl and @ mg ketorolac ) and oxycodone group ( @ mg oxycodone and @ mg ketorolac ) .


After the operation , a blinded observer assessed pain using a numerical rating scale ( NRS ) , infused PCA dose , side effects , sedation levels , and satisfaction .


Cumulative PCA dose of oxycodone group at @ h ( @ @ ml ) was significantly less than that of fentanyl group ( @ @ ml , P = @ ) .


Oxycodone group showed more nausea at @-@ h after the operation ( P = @ ) , but there was no difference in satisfaction score ( P = @ ) .


There were no significant differences in other side effects , sedation and NRS scores between two groups .


Oxycodone showed comparable effects for pain relief compared to fentanyl in spite of less cumulative PCA dose .


Based on these results , we could conclude that oxycodone may be useful as an alternative to fentanyl for PCA after laparoscopic cholecystectomy .


To compare the visual and refractive out-comes of femtosecond laser-assisted LASIK with small-incision lenticule extraction ( SMILE ) in terms of visual acuity , contrast sensitivity , aberrations , and dry eye .


A single-center prospective randomized study in which patients diagnosed as having myopia presenting for refractive correction were allocated to either a LASIK or SMILE group .


The primary outcome measures were refractive efficacy , predictability , and safety , postoperative contrast sensitivity , aberrations , and dry eye status .


Patients were followed up at days @ and @ and @ months ; postoperative uncorrected visual acuity ( UCVA ) , aberrations , dry eye , and contrast sensitivity were recorded and compared to preoperative data .


Two postoperative subjective questionnaires were used to assess pain , pricking sensation , redness , glare , and overall patient satisfaction .


At day @ postoperatively , @ ( @ % ) of @ eyes in the SMILE group achieved a UCVA of @/@ compared with @ ( @ % ) of @ eyes in the LASIK group .


At day @ postoperatively , contrast sensitivity was similar in the two groups ( P = @ ) , but by @ months , it was better in the SMILE group than the LASIK group at all spatial frequencies ( P < @ ) .


At @ months postoperatively , @ ( @ % ) eyes in each group achieved a UCVA of @/@ , with @ ( @ % ) eyes in the SMILE group and @ ( @ % ) eyes in the LASIK group achieving @/@ .


Higher-order aberrations at @ months postoperatively were significantly higher in the LASIK group ( @ + @ pm ) than in the SMILE group ( @ + @ pm ; P < @ ) .


Postoperative dry eye and glare were significantly more common following LASIK ( P < @ ) .


Three-month results demonstrate that refractive accuracy , dry eye , contrast , and induced aberrations are better following SMILE rather than LASIK .


Therapies for post-traumatic stress disorder ( PTSD ) endorsed by the Department of Defense and Veterans Administration are relatively lengthy , costly , and yield variable success .


We evaluated Accelerated Resolution Therapy ( ART ) for the treatment of combat-related psychological trauma .


A randomized controlled trial of ART versus an Attention Control ( AC ) regimen was conducted among @ U.S. service members/veterans .


After random assignment , those assigned to AC were offered crossover to ART , with @-month follow-up on all participants .


Self-report symptoms of PTSD and comorbidities were analyzed among study completers and by the intention-to-treat principle .


Mean age was @ @ years with @ % female , @ % Army , and @ % with prior PTSD treatment .


The ART was delivered in @ @ sessions with a @ % completion rate .


Mean reductions in symptoms of PTSD , depression , anxiety , and trauma-related guilt were significantly greater ( p < @ ) with ART compared to AC .


Favorable results for those treated with ART persisted at @ months , including reduction in aggression ( p < @ ) .


Adverse treatment-related events were rare and not serious .


ART appears to be a safe and effective treatment for symptoms of combat-related PTSD , including refractory PTSD , and is delivered in significantly less time than therapies endorsed by the Department of Defense and Veterans Administration .


Current treatments for low back pain have small effects .


A research priority is to identify patient characteristics associated with larger effects for specific interventions .


The aim of this study was to identify simple clinical characteristics of patients with chronic low back pain who would benefit more from either motor control exercises or graded activity .


This study was a secondary analysis of the results of a randomized controlled trial .


One hundred seventy-two patients with chronic low back pain were enrolled in the trial , which was conducted in Australian physical therapy clinics .


The treatment consisted of @ initial exercise sessions over an @-week period and booster sessions at @ and @ months following randomization .


The putative effect modifiers ( psychosocial features , physical activity level , walking tolerance , and self-reported signs of clinical instability ) were measured at baseline .


Measures of pain and function ( both measured on a @-@ scale ) were taken at baseline and at @ , @ , and @ months by a blinded assessor .


Self-reported clinical instability was a statistically significant and clinically important modifier of treatment response for @-month function ( interaction : @ ; @ % confidence interval = @ to @ ) .


Participants with high scores on the clinical instability questionnaire ( @ ) did @ points better with motor control exercises , whereas those who had low scores ( < @ ) did @ points better with graded activity .


Most other effect modifiers investigated did not appear to be useful in identifying preferential response to exercise type .


The psychometric properties of the instability questionnaire have not been fully tested .


A simple @-item questionnaire of features considered indicative of clinical instability can identify patients who respond best to either motor control exercises or graded activity .


The multicomponent serogroup B meningococcal ( @CMenB ) vaccine induces antibodies against indicator strains of serogroup B meningococcus under various schedules .


We investigated the persistence of antibodies in @-year-old children @-@ months after their last dose ( at about @ years of age ) .


We assessed @-year-old children who received the @CMenB vaccine or a recombinant protein vaccine in a previous randomized trial .


We also recruited @ vaccine-naive @-year-olds and administered @ doses of @CMenB to each child .


We measured serum bactericidal antibody titres against @ indicator strains of serogroup B meningococcus matched to each individual vaccine component and against @ mismatched strains .


Of those who received the @CMenB vaccine at @ , @ , @ , @ and @ months ( n = @ ) , the percentage with protective antibody titres ( @:@ ) at @ months ranged from @ % to @ % against matched strains and from @ % to @ % against mismatched strains .


Loss of protective titres was also observed for those who received the @CMenB vaccine at @ , @ and @ months ( n = @ ) ( @ % -@ % against matched strains , @ % -@ % against mismatched strains ) or at @ and @ months ( n = @ ) ( @ % -@ % against matched strains , @ % -@ % against mismatched strains ) .


Administering the @CMenB vaccine to @-year-old children yielded protective titres against matched strains in @ % -@ % and against mismatched strains in @ % -@ % .


The majority of these children reported injection-site pain ( @/@ -LSB- @ % -RSB- after dose @ , @/@ -LSB- @ % -RSB- after dose @ ) and erythema ( @/@ -LSB- @ % -RSB- and @/@ -LSB- @ % -RSB- , respectively ) ; rates of fever were low ( @/@ -LSB- @ % -RSB- and @/@ -LSB- @ % -RSB- , respectively ) .


Waning of immunity by @ years of age occurred after receipt of the @CMenB vaccine in infancy , even with an additional booster at @ months .


The @CMenB vaccine is immunogenic and was fairly well tolerated by @-year-old children , although injection-site pain was noteworthy .


To evaluate the effect of drainage tube on prognosis after total knee arthroplasty ( TKA ) and explore an effective treatment with favorable prognosis .


In a prospective study , @ patients with TKA for the first time were included and randomly divided into three groups , group A ( no placement of drainage tube ) , group B ( negative pressure drainage ) , and group C ( @ h clamping drainage ) .


Intraoperative and postoperative blood loss , operation time , and the drainage volume were recorded and analyzed .


Arthrocele , ecchymosis , and range of motion ( ROM ) were examined postoperatively .


The degree of pain was scored by Visual Analog Scale ( VAS ) after @ , @ , and @ h of operation .


The complications were examined and HSS ( hospital for special surgery ) knee score was taken during the follow-up period .


There was no significant difference in operation time , total blood loss , intraoperative blood loss , and VAS score among three groups .


Meanwhile , the hidden blood loss in group B was significantly decreased compared with group A ( P = @ ) .


The postoperative drainage volume of group B was significantly increased compared with group C ( P = @ ) .


No drainage increased the rate of arthrocele and ecchymosis .


Compared with group A , ROM after @ days of operation in groups B and C was significantly increased ( P = @ , P = @ , respectively ) .


During follow-up study , no deep infection or deep venous thrombosis was found .


After TKA , early clamping of the drainage tube reduced the bleeding loss without adverse effect on prognosis , which might be useful for clinical application in future .


The main goal of this study was to achieve a medico-economic comparison between four disposable laryngeal masks ( LM ) ( LMA-Unique , Ambu AuraOnce , I-Gel and LMA-Suprme ) .


A prospective , randomized , monocentre study .


In a center , using routinely LMA-Unique masks , scheduled breast surgery patients were allocated into four groups according to the LM model .


After the induction , the modalities of use were collected , as well as the intraoperative events that required additional anesthetic equipment .


The real cost of each model was calculated ( cost of the mask + extra cost related to complications ) .


Using the LMA-Unique as a reference , we performed a cost-efficacy analysis .


We realized a cost-efficiency analysis putting in parallel the impact on the cost and the incidence of the events .


A total of @ patients were included .


According to the cost-efficacy analysis , the dominant model was the Ambu AuraOnce ( real cost : -@ % , events : -@ % ) .


The LMA-Unique was dominated because of a high morbidity rate .


The I-Gel and LMA-Suprme models were more efficient but more expensive ( real cost : +@ % and +@ % respectively ) .


To compensate for additional costs , it would be necessary to apply a price reduction of at least @ % .


Despite their better efficiency and safety , the latest generation laryngeal masks are still expensive in spite of a low rate of complication .


These results do not take into account very rare and severe complications not met in this study in the limited size ; then the economic and medical impact can influence the choice beyond the simple analysis cost-efficiency .


We evaluated the safety and efficacy of a novel disposable male circumcision ( MC ) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co. , Ltd. .


Adult male patients ( n = @ ; mean age , @ years ) with redundant foreskin and/or phimosis were included in a randomized , multicenter pilot clinical trial from October @ to February @ .


Patients were divided into @ groups and subjected to MC with a novel disposable device ( Device Group ) ( n = @ ) or to conventional dissection technique ( CDT ) ( Control Group ) ( n = @ ) .


Intraoperative bleeding , surgery duration , pain , healing , and satisfaction with penis appearance were assessed .


Adverse events ( AEs ) were noted .


Intraoperative bleeding volume -LSB- @ @ ( @-@ ) ml vs. @ @ ( @-@ ) ml -RSB- and mean surgical time -LSB- @ @ ( @-@ ) min vs. @ @ ( @-@ ) min -RSB- in the Device Group were significantly less than in the Control Group ( P < @ ) .


No AEs were observed in either group .


There were no significant differences in postoperative pain , healing , or satisfaction with penis appearance between groups ( P > @ ) .


This novel disposable circumcision device produced satisfactory preliminary adult MC results compared with CDT treatments .


This device may be broadly used in men , such as those with phimosis , who are ineligible for CDT .


Increased potassium intake is related to reduced blood pressure ( BP ) and reduced stroke rate .


The effect of increased dietary potassium on endothelial function remains unknown .


The aim was to determine the effect of increased dietary potassium from fruit and vegetables on endothelial function .


Thirty five healthy men and women ( age @ @ y ) successfully completed a randomised cross-over study of @ @ day diets either high or low in potassium .


Flow mediated dilatation ( FMD ) , BP , pulse wave velocity ( PWV ) , augmentation index ( AI ) and a fasting blood sample for analysis of Intercellular Adhesion Molecule-@ ( ICAM-@ ) , E-selectin , asymmetric dimethylarginine ( ADMA ) and endothelin-@ were taken on completion of each intervention .


Dietary change was achieved by including bananas and potatoes in the high potassium and apples and rice/pasta in the low potassium diet .


Dietary adherence was assessed using @ day weighed food diaries and a @ h urine sample .


The difference in potassium excretion between the two diets was @ @ mmol/d ( P = @ ) .


Fasting FMD was significantly improved by @ % @ % following the high compared to the low potassium diet ( P = @ ) .


There were no significant differences in BP , PWV , AI , ICAM-@ , ADMA or endothelin-@ between the interventions .


There was a significant reduction in E-selectin following the high ( Median = @ ng/ml ) vs the low potassium diet ( Median = @ ng/ml ) , z = -@ , P = @ .


Increased dietary potassium from fruit and vegetables improves FMD within @ week in healthy men and women but the mechanisms for this effect remain unclear .


Spine Patient Outcomes Research Trial subgroup analysis .


To evaluate the effect of high obesity on management of lumbar spinal stenosis , degenerative spondylolisthesis ( DS ) , and intervertebral disc herniation ( IDH ) .


Prior Spine Patient Outcomes Research Trial analyses compared nonobese and obese patients .


This study compares nonobese patients ( body mass index < @ kg/m ) with those with class I obesity ( body mass index = @-@ kg/m ) and class II/III high obesity ( body mass index@ kg/m ) .


For spinal stenosis , @ of @ nonobese patients , @ of @ obese patients , and @ of @ highly obese patients underwent surgery .


For DS , @ of @ nonobese patients , @ of @ obese patients , and @ of @ highly obese patients underwent surgery .


For IDH , @ of @ nonobese patients , @ of @ obese patients , and @ of @ highly obese patients underwent surgery .


Outcomes included Short Form-@ , Oswestry Disability Index , stenosis/sciatica bothersomeness index , low back pain bothersomeness index , operative events , complications , and reoperations .


Operative and nonoperative outcomes were compared by change from baseline at each follow-up interval using a mixed effects longitudinal regression model .


An as-treated analysis was performed because of crossover between surgical and nonoperative groups .


Highly obese patients had increased comorbidities .


Baseline Short Form-@ physical function scores were lowest for highly obese patients .


For spinal stenosis , surgical treatment effect and difference in operative events among groups were not significantly different.For DS , greatest treatment effect for the highly obese group was found in most primary outcome measures , and is attributable to the significantly poorer nonoperative outcomes .


Operative times and wound infection rates were greatest for highly obese patients.For IDH , highly obese patients experienced less improvement postoperatively compared with obese and nonobese patients .


However , nonoperative treatment for highly obese patients was even worse , resulting in greater treatment effect in almost all measures .


Operative time was greatest for highly obese patients .


Blood loss and length of stay was greater for both obese cohorts .


Highly obese patients with DS experienced longer operative times and increased infection .


Operative time was greatest for highly obese patients with IDH .


DS and IDH saw greater surgical treatment effect for highly obese patients due to poor outcomes of nonsurgical management .


Laparoscopy training courses have been established in many centers worldwide to ensure adequate skill learning before performing operations on patients .


Different training modalities and their combinations have been compared regarding training effects .


Multimodality training combines different approaches for optimal training outcome .


However , no standards currently exist for the number of trainees assigned per workplace .


This is a monocentric , open , three-arm randomized controlled trial .


The participants are laparoscopically-naive medical students from Heidelberg University .


After a standardized introduction to laparoscopic cholecystectomy ( LC ) with online learning modules , the participants perform a baseline test for basic skills and LC performance on a virtual reality ( VR ) trainer .


A total of @ students will be randomized into three study arms , in a @:@:@ ratio .


The intervention groups participate individually ( Group @ ) or in pairs ( Group @ ) in a standardized and structured multimodality training curriculum .


Basic skills are trained on the box and VR trainers .


Procedural skills and LC modules are trained on the VR trainer .


The control group ( Group C ) does not receive training between tests .


A post-test is performed to reassess basic skills and LC performance on the VR trainer .


The performance of a cadaveric porcine LC is then measured as the primary outcome using standardized and validated ratings by blinded experts with the Objective Structured Assessment of Technical Skills .


The Global Operative Assessment of Laparoscopic Surgical skills score and the time taken for completion are used as secondary outcome measures as well as the improvement of skills and VR LC performance between baseline and post-test .


Cognitive tests and questionnaires are used to identify individual factors that might exert influence on training outcome .


This study aims to assess whether workplaces in laparoscopy training courses for beginners should be used by one trainee or two trainees simultaneously , by measuring the impact on operative performance and learning curves .


Possible factors of influence , such as the role of observing the training partner , exchange of thoughts , active reflection , model learning , motivation , pauses , and sympathy will be explored in the data analysis .


This study will help optimize the efficiency of laparoscopy training courses .


Limited time and lack of knowledge are barriers to physical activity counseling in primary care .


The objective of this study was to examine the effectiveness of a clinician-targeted intervention that used the @As ( Ask , Advise , Agree , Assist , Arrange ) approach to physical activity counseling in a medically underserved patient population .


Family medicine clinicians at @ community health centers were randomized to Group @ or Group @ intervention .


Both clinician groups participated in @ training sessions on the @As for physical activity counseling ; Group @ training took place @ months after Group @ training .


Both groups were trained to refer patients to a community exercise program .


We used a pre-post analysis to evaluate the effectiveness of the intervention on clinician use of @As .


Eligible patients ( n = @ ) rated their clinicians ' counseling skills by using a modified Physical Activity Exit Interview ( PAEI ) survey .


Clinicians ( n = @ ) self-assessed their use of the @As through a survey and interviews .


Both patient and clinician groups had similar sociodemographic characteristics .


The PAEI score for both groups combined increased from @ to @ ( on a scale of @-@ ) from baseline to immediately postintervention ( P = @ ) and was @ ( P = @ ) at @-month follow-up ; most of the improvement in PAEI score was due to increased use of @As skills by Group @ clinicians .


Group @ reported difficulty with problem solving , whereas Group @ reported ease of referral to the community exercise program .


A clinician training intervention showed mixed results for @As physical activity counseling .


Antipsychotics , such as aripiprazole and risperidone , are often used to treat individuals with schizophrenia .


The efficacy as well as safety of aripiprazole in Western populations has been described .


The objective of this study is to investigate the efficacy , safety , and tolerability of aripiprazole and risperidone in Chinese Han schizophrenia subjects in mainland China .


The @-week , double-blind , randomized , parallel study was conducted in @ medical centers in mainland China from November @ to March @ .


A total of @ subjects with a primary DSM-IV diagnosis of schizophrenia were randomly assigned ( with a randomization ratio of @:@ ) to aripiprazole ( n = @ ) or risperidone ( n = @ ) .


Efficacy measurements included the Positive and Negative Syndrome Scale ( PANSS ) total , positive , negative and general psychopathology subscale scores , and Clinical Global Impressions-Severity of Illness ( CGI-S ) , and Improvement scale scores .


Extrapyramidal symptoms ( EPS ) , weight gain , serum prolactin level , QTc interval , and self-reported adverse events were also assessed as measures of safety and tolerability .


Both the aripiprazole and risperidone groups showed statistically significant improvement of PANSS total , positive , negative , general psychopathology subscale scores , and CGI-S scores from baseline to the endpoint ( all p < @ ) .


Significant improvement was noted in the first week for both treatment groups .


There were no significant differences in efficacy measurements between the two treatment groups .


Mean change of PANSS total scores from baseline to the endpoint was -@ for aripiprazole and -@ for risperidone , ( p = @ ) .


The responder rate was @ % ( n = @ ) and @ % ( n = @ ) for aripiprazole and risperidone , respectively , ( p = @ ) .


The incidences of EPS were similar in the aripiprazole ( @ % , n = @ ) and risperidone groups ( @ % , n = @ ) , respectively ( p = @ ) .


No clinically meaningful effects on QTc interval , QRS duration , or PR interval were observed in either treatment groups .


However , the incidence of clinically significant weight gain ( p = @ ) and hyperprolactinemia ( p < @ ) in the aripiprazole group was significantly lower than in the risperidone group .


The study demonstrated that aripiprazole , as well as risperidone , had rapid and persistent efficacy for psychotic symptoms from the first week of therapy .


There may be poor efficacy for aripiprazole compared with risperidone for overall improvement , but there were no significant differences in this study .


Aripiprazole showed good tolerability with less weight gain and hyperprolactinemia compared with risperidone .


The overall efficacy and safety of aripiprazole in Chinese Han schizophrenia subjects were similar to that reported in Western populations .


To observe the effectiveness and safety of Kangquan Recipe ( , KQR ) for benign prostatic hyperplasia ( BPH ) patients .


One hundred and six BPH patients were randomly assigned to the treatment group ( @ cases ) and the control group ( @ cases ) according to a random number table .


The treatment group was given KQR orally ; the control group was given cernilton orally .


After @-week treatment , the clinical effect and safety were evaluated using the International Prostatic Symptom Score ( I-PSS ) , quality of life ( QOL ) , maximum flow rate ( Qmax ) , average flow rate ( Qave ) , residual urine volume ( RUV ) , total prostatic volume ( TPV ) , etc. .


After treatment , the score of I-PSS was decreased from @ to @ in the treatment group , significantly lower compared with the control group ; the levels of Qmax and Qave were from @ to @ and @ to @ ( mL/s ) in the treatment group , significantly higher compared with the control group ; the levels of RUV and TPV were from @ to @ and @ to @ ( mL ) in the treatment group , significantly lower compared with the control group ( all P < @ ) .


The incidence rate of adverse reaction was similar between the two groups ( P > @ ) .


KQR is effective and safe for the treatment of BPH .


Overweight or obesity is prevalent among college students and many gain weight during this time .


Traditional face-to-face weight loss interventions have not worked well in this population .


Facebook is an attractive tool for delivering weight loss interventions for college students because of its popularity , potential to deliver strategies found in successful weight loss interventions , and ability to support ongoing adaptation of intervention content .


The objective of this study was to describe participant exposure to a Facebook page designed to deliver content to overweight/obese college students in a weight loss randomized controlled trial ( N = @ ) and examine participant engagement with behavior change campaigns for weight loss delivered via Facebook .


The basis of the intervention campaign model were @ self-regulatory techniques : intention formation , action planning , feedback , goal review , and self-monitoring .


Participants were encouraged to engage their existing social network to meet their weight loss goals .


A health coach moderated the page and modified content based on usage patterns and user feedback .


Quantitative analyses were conducted at the Facebook post - and participant-level of analysis .


Participant engagement was quantified by Facebook post type ( eg , status update ) and interaction ( eg , like ) and stratified by weight loss campaign ( sequenced vs nonsequenced ) .


A subset of participants were interviewed to evaluate the presence of passive online engagement or `` lurking . ''


The health coach posted @ unique messages to the study 's Facebook page over @ months , averaging @ posts per day ( SD @ , range @-@ ) .


In all , @ % ( @/@ ) of the posts were interacted with at least once ( eg , liked ) .


Of these , approximately @ % ( @/@ ) had @-@ interactions , @ % ( @/@ ) had @-@ interactions , @ % ( @/@ ) had @-@ interactions , and @ posts had @ or more interactions ( @ % , @/@ ) .


There was significant variability among quantifiable ( ie , visible ) engagement .


Of @ participants in the final intervention sample , @ ( @ % ) were highly active users and @ ( @ % ) never visibly engaged with the intervention on Facebook .


Polls were the most popular type of post followed by photos , with @ % ( @/@ ) and @ % ( @/@ ) interacted with at least once .


Participants visibly engaged less with posts over time ( partial r = -@ ; P < @ ) .


Approximately @ % of the participants interviewed ( @/@ , @ % ) reported passively engaging with the Facebook posts by reading but not visibly interacting with them .


Facebook can be used to remotely deliver weight loss intervention content to college students with the help of a health coach who can iteratively tailor content and interact with participants .


However , visible engagement with the study 's Facebook page was highly variable and declined over time .


Whether the level of observed engagement is meaningful in terms of influencing changes in weight behaviors and outcomes will be evaluated at the completion of the overall study .


Recent research suggests that safety behaviors ( SB ) may not preclude treatment gains in exposure-based therapy for obsessive-compulsive disorder .


However , it is relatively unknown what specific types of SBs may be detrimental to the therapeutic process , with some arguing that SBs be classified based on their function .


The current study sought to examine the extent to which different SBs enhanced or weakened symptoms of contamination fear during a single session of exposure .


Sixty-seven non-clinical students were randomly assigned to one of three conditions : ( @ ) exposure with no SBs ( NSB ) , ( @ ) exposure with preventive SBs ( PSB ) , or ( @ ) exposure with restorative SBs ( RSB ) .


Among the primary outcome measures , greater reductions in fear and behavioral avoidance were found for RSB in comparison to PSB , and the gains made by RSB were generalizable to other sources of potential contamination .


Furthermore , RSB resulted in more rapid reductions in fear and disgust across repeated exposure trials .


Limitations include the use of a nonclinical student sample .


Overall , the current study suggests that RSB may be beneficial as an adjunct to therapy whereas PSB are potentially detrimental .


Results of the study are discussed in terms of exposure theories and the treatment of anxiety disorders .


To compare the effects of two @-month parent-implemented interventions within the Early Social Interaction ( ESI ) Project .


Both individual-ESI , offered @ or @ times per week at home or in the community , and group-ESI , offered once per week in a clinic , taught parents how to embed strategies to support social communication throughout everyday activities .


Participants in the randomized controlled trial included @ children diagnosed with autism spectrum disorder at @ to @ months .


Children were matched on pretreatment nonverbal developmental level and pairs were randomly assigned to treatment condition .


Child outcomes included measures of social communication , autism symptoms , adaptive behavior , and developmental level .


Child outcomes are reported from baseline to the end of the @-month interventions .


Children in individual-ESI showed differential change on a standardized examiner-administered observational measure of social communication , as they improved at a faster rate than children in group-ESI .


Individual-ESI also showed differential efficacy on a parent report measure of communication , daily living , and social skills , as they showed improvement or stability , whereas group-ESI led to worsening or no significant change on these skills .


Finally , individual-ESI showed differential change on examiner-administered measures of receptive language skills , as children in individual-ESI improved significantly , whereas group-ESI showed no change .


These findings support the efficacy of individual-ESI compared with group-ESI on child outcomes , suggesting the importance of individualized parent coaching in natural environments .


The efficacy of a parent-implemented intervention using little professional time has potential for community viability , which is particularly important in light of the lack of main effects on child outcomes of most other parent-implemented interventions .


Japanese cedar ( JC ) pollinosis is the most common seasonal allergic rhinitis in Japan .


Standardized JC pollen extract is available for subcutaneous immunotherapy , but this treatment is limited by potentially serious side effects .


The aim of this double-blind , randomized comparative study was to evaluate the efficacy and safety of standardized JC pollen extract in a new oral formulation ( CEDARTOLEN , Torii Pharmaceutical Co. , Ltd. , Tokyo , Japan ) for sublingual immunotherapy ( SLIT ) for JC pollinosis .


A total of @ subjects with JC pollinosis were randomized into @ groups at a ratio of @:@ to receive daily sublingual administration of standardized JC pollen extract with a maintenance dose of @,@ Japanese allergy units ( JAU ) or placebo for @ consecutive pollen seasons .


The efficacy was evaluated using the total nasal symptom and medication score ( TNSMS ) as the primary end point .


Secondary end points included the total ocular symptom and medication score ( TOSMS ) and scores for individual symptoms and medication .


The TNSMS was significantly lower ( p < @ ) in the SLIT group than in the placebo group in the peak symptom period by @ and @ % in the first and second seasons , respectively .


All secondary end points were also significantly lower in the SLIT group in both seasons .


No systemic anaphylaxis occurred .


SLIT with daily administration of standardized JC pollen extract was effective for improving nasal and ocular symptoms of JC pollinosis and reducing the use of relief medication .


The JC pollen extract was well tolerated with only local adverse events .


To investigate the treatment outcome of discontinuing @ medication from @-year combination therapy for male benign prostatic hyperplasia/lower urinary tract symptoms .


Patients with International Prostate Symptom Score @ , total prostatic volume ( TPV ) > @ mL , and maximum flow rate ( Qmax ) < @ mL/s were randomly assigned to the @-reductase inhibitor ( @ARI ) discontinue ( DC-@ARI ) or - blocker discontinue ( DC -- blocker ) group .


All patients received combination therapy with dutasteride ( @ mg QD ) and doxazosin ( @ mg QD ) for @ years and then discontinued either one drug for @ months .


The primary endpoint was the occurrence of resuming medication .


The secondary endpoints were the net parameters changed or the need of transurethral resection of the prostate ( TURP ) .


A total of @ patients in DC-@ARI and @ in DC -- blocker group completed the study .


The baseline TPV and Qmax were similar between groups before combination therapy .


Resumption of combination therapy was significantly more in DC-@ARI than DC -- blocker group ( @ % vs @ % ; P = @ ) .


The mean duration from discontinuing to resuming medication was @ @ months in DC -- blocker and @ @ months in DC-@ARI group ( P < @ ) .


The TPV progression ( @ % vs @ % ; P < @ ) and the need for TURP ( @ % vs @ % ; P = @ ) were significantly higher in DC-@ARI than DC -- blocker group .


Patients with larger TPV ( @ @ mL ) had significantly greater need for resuming @ARI than smaller TPV ( @ @ mL ; P = @ ) , and a lower Qmax might predict resuming - blocker .


After a @-year combination therapy , discontinuation of either one drug induced benign prostatic hyperplasia progression in either group .


Greater risk of resuming medication and needing TURP were noted in patients who discontinued @ARI .


A combined heart rate ( HR ) and motion sensor ( Actiheart ) has been proposed as an accurate method for assessing total energy expenditure ( TEE ) and physical activity energy expenditure ( PAEE ) .


However , the extent to which factors such as caffeine may affect the accuracy by which the estimated HR-related PAEE contribution will affect TEE and PAEE estimates is unknown .


Therefore , we examined the validity of Actiheart in estimating TEE and PAEE in free-living adults under a caffeine trial compared with doubly labeled water ( DLW ) as reference criterion .


Using a double-blind crossover trial ( Clinicaltrials.gov ID : #NCT @ ) with two conditions ( @-day each with a @-day-washout period ) , randomly ordered as caffeine ( @ mg/kg per day ) and placebo ( malt-dextrine ) intake , TEE was measured by DLW in @ physically active men ( @-@ years ) who were non-caffeine users .


In each condition , resting energy expenditure ( REE ) was assessed by indirect calorimetry and PAEE was calculated as ( TEE - ( REE +@ TEE ) ) .


Simultaneously , PAEE and TEE were estimated by Actiheart using an individual calibration ( ACC+HR step ) .


Under caffeine , ACC+HR step explained @ and @ % of TEE and PAEE from DLW , respectively ; corresponding results for the placebo condition were @ and @ % .


No mean bias was found between ACC+HR step and DLW for TEE ( caffeine : -@ kJ per day ; placebo : -@ kJ per day ) , although PAEE was slightly underestimated ( caffeine : -@ kJ per day ; placebo : -@ kJ per day ) .


Similar limits of agreement were observed in both conditions ranging from -@ to @ and from -@ to @ kJ per day for TEE and PAEE , respectively .


Regardless of caffeine intake , the combined HR and motion sensor is valid for estimating free-living energy expenditure in a group of healthy men but is less accurate for an individual assessment .


The purpose of the study was to assess the impact of dutasteride plus tamsulosin combination therapy , compared with dutasteride or tamsulosin monotherapy , on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) using data from the @-year CombAT study .


Nocturia was assessed using Question @ of the International Prostate Symptom Score questionnaire .


Efficacy measures included as follows : mean change in nocturia at @-month intervals up to @ months ; proportion of patients with improvement/worsening in nocturia ; nocturnal voiding frequency at baseline and study end , overall and by baseline subgroups ; and nocturnal voiding frequency < @ at study end in patients with a baseline score @ .


In total , @,@ patients with a mean age of @ years were included .


Mean nocturia improvements were significantly superior ( p @ ) with combination therapy than with either monotherapy ( adjusted mean change from baseline in IPSS Question @ score at month @ : combination therapy -@ , dutasteride -@ , tamsulosin -@ ) .


Reduction in nocturia score with combination therapy was significantly ( p @ ) better than tamsulosin monotherapy across all baseline subgroups tested , except for men with previous @ARI use .


Among those with a baseline IPSS Q@ score @ , more patients with combination therapy had a score < @ at month @ ( @ % ) compared with dutasteride ( @ % , p = @ ) or tamsulosin ( @ % , p < @ ) .


Combination therapy provided greater improvements and less worsening of nocturia compared with both dutasteride and tamsulosin monotherapies .


These analyses are the first to show greater improvement with a @ARI / - blocker combination versus either agent alone for the management of nocturia in patients with LUTS/BPH .


Acute stress can increase fatigability and decrease steadiness of sustained low-force contractions that are required for functional tasks in upper limb muscles .


Whether motor performance is more impaired in people with a chronic stress disorder is not known .


This study compared the fatigability and steadiness ( force fluctuations ) of handgrip muscles in veterans with posttraumatic stress disorder ( PTSD ) and civilian controls in the presence and absence of varying levels of cognitive demand .


Eighteen veterans with PTSD and @ healthy controls ( @ @ yr ) attended three randomized experimental sessions to perform an isometric fatiguing contraction ( @ % of maximal strength ) with the handgrip muscles .


Two sessions involved performing a cognitive task during the fatiguing contraction : @ ) difficult mental math task ( stressor ) and @ ) a simple mental math task ( mental attentiveness ) .


A third session involved a fatiguing contraction with no mental task ( control ) .


Stress elevated heart rate , blood pressure , and levels of anxiety in veterans with PTSD ( P < @ ) but blunted cortisol levels ( P < @ ) .


Time to failure was briefer ( @ @ vs @ @ min , P = @ ) , and force fluctuations increased at a greater rate for veterans with PTSD than for controls ( P < @ ) .


Cognitive stress did not influence time to failure or force fluctuations for either group ( P > @ ) .


Veterans with PTSD demonstrated greater fatigability and loss of steadiness ( greater force fluctuations ) of the handgrip muscles compared with healthy controls .


Male veterans with PTSD demonstrated altered neuromuscular function of arm muscles that potentially affects functional tasks during daily , ergonomic , and military activities .


For patients with diabetes and triple-vessel disease , coronary artery bypass grafting ( CABG ) surgery is a well-established procedure , but cardiopulmonary bypass support may also lead to severe complications to these patients .


The aim of this study was to compare myocardial protection and early outcomes in patients with diabetes and triple-vessel disease following different coronary surgical techniques .


Prospective randomized trial of patients treated at the First Affiliated Hospital of China Medical University over a @-year period ( @ - @ ) .


In a single-center randomized trial , @ patients with diabetes and triple-vessel disease were randomly assigned to off-pump ( OPCAB ) ( number -LSB- n -RSB- = @ ) , on-pump beating heart ( OnP-BH ) ( n = @ ) , and conventional CABG ( OnP ) ( n = @ ) between January @ and October @ .


Myocardial injury was assessed by measuring the serial release of cardiac troponin I ( cTnI ) preoperatively , @ hour , @ hours , @ hours , and @ hours postoperatively .


The early outcomes were compared among these @ groups .


Preoperative characteristics of the patients in all @ groups were similar .


No significant difference was found regarding the number of anastomoses , the use of the internal thoracic artery , postoperative new-onset atrial fibrillation , hemodialysis , stroke , reoperation for bleeding , and infective complications in the @ groups ( P > @ ) .


The complete revascularization , postoperative drainage loss , intra-aortic balloon pump support , blood requirements , postoperative myocardial infarction , pulmonary complications , gastrointestinal complications , inotropic requirements > @ hours , ventilation > @ hours , intensive care unit stay > @ hours , and in-hospital stay > @ days were significantly lower in the OPCAB group than in the other @ groups ( P < @ ) .


In-hospital mortality was lower in the OPCAB group than in the other @ groups , but no statistical difference was observed ( P > @ ) .


Preoperative cTnI in the @ groups was similar ( P > @ ) ; however , the lowest cTnI value was noted in the OPCAB group , followed by the OnP group , and it was highest in the OnP-BH group @ hour , @ hours , @ hours , and @ hours postoperatively ( P < @ ) .


OPCAB is superior to the OnP-BH and OnP techniques in terms of postoperative complications and myocardial protection in patients with diabetes and triple-vessel disease .


Myocardial injury in the OnP-BH group was significantly higher than that in the OnP group .


This study aims to investigate and evaluate the efficacy and safety of early enteral nutrition ( EN ) in maintaining and improving the postoperative nutritional status in patients undergoing esophagectomy .


A randomized , controlled clinical trial was conducted in @ adult patients with esophageal cancer and undergoing esophagectomy .


Patients were randomly divided into two groups receiving either EN ( N. = @ ) or parenteral nutrition ( PN ) ( N. = @ ) postoperatively .


The nutritional intake was isonitrogenic and isocalorie for both groups .


Nutritional status was evaluated preoperatively as well as on postoperative day I and day @ .


Daily nitrogen balance was measured and @-day cumulative nitrogen balance was calculated .


The levels of serum markers including d-lactate , diamine oxidase ( DAO ) , and endotoxin were determined on @st , @th and @th postoperative day for analyzing intestinal barrier function .


Postoperative infection rate and the incidence of nutrition support-related complications were examined .


The concentrations of serum albumin and prealbumin in patients of EN group were significantly higher than those in PN group and the concentrations of blood glucose , - GT , AKP , TB , and DB were significantly lower compared to those in the PN group ( P < @ ) .


Both daily nitrogen balance and cumulative nitrogen balance of EN group were better than those of PN group since postoperative day III .


The serum levels of d-lactate , DAO , and endotoxin of EN group were significantly lower than those of PN group on postoperative day VIII ( P < @ ) .


The incidence of postoperative infections in blood , lung , and intestinal tract in EN group was lower compared to PN group ( P < @ ) .


No severe complications associated with nutritional support occurred in EN group .


The time to flatus passage in EN group was significantly shorter , and the cost of nutritional support was significantly less compared to PN group ( P < @ ) .


Postoperative early enteral nutrition was safe and feasible for patients undergoing esophagectomy .


Compared to PN , EN more efficiently ameliorated postoperational nutritional status of the patients undergoing esophagectomy , played an important role in restoring intestinal barrier function postoperatively , reduced the incidence of postoperative infection , and decreased the cost of hospital stay .


Intravenous N-methyl-d-aspartate ( NMDA ) antagonists have shown promising results in rapidly ameliorating depression symptoms , but placebo-controlled trials of oral NMDA antagonists as monotherapy have not observed efficacy .


We conducted a randomized , double-blind , placebo-controlled trial of the NMDA antagonist memantine as an augmentation treatment for patients with DSM-IV major depressive disorder .


Adult outpatients with major depressive disorder and partial response or nonresponse to their current antidepressant ( as indicated by a @-item Hamilton Depression Rating Scale score of @ at baseline ) were randomized ( from July @-December @ ) to add memantine ( flexible dose @-@ mg/d , with all memantine group participants reaching the dose of @ mg/d ) ( n = @ ) or placebo ( n = @ ) to their existing treatment for @ weeks .


The primary outcome , change in Montgomery-Asberg Depression Rating Score ( MADRS ) , was evaluated with repeated-measures mixed effects models using last-observation-carried-forward methods .


Secondary outcomes included other depression and anxiety rating scales , suicidal and delusional ideation , and other adverse effects .


@ % of participants completed the trial , including @ % of participants receiving memantine .


Participants receiving memantine did not show a statistically or clinically significant change in MADRS scores compared to placebo , either over the entire study ( = @ , favoring placebo , P = @ ) or at study completion ( week @ mean -LSB- SD -RSB- MADRS score change = -@ -LSB- @ -RSB- -LSB- memantine -RSB- ; -@ -LSB- @ -RSB- -LSB- placebo -RSB- ; P = @ ) .


A minimal to small effect size ( comparing change to baseline variability ) favoring placebo was observed ( Cohen d = @ ) .


Similarly , no substantial effect sizes favoring memantine nor statistically significant between-group differences were observed on secondary efficacy outcomes .


This trial did not detect significant statistical or effect size differences between memantine and placebo augmentation among nonresponders or poor responders to conventional antidepressants .


While the small number of participants is a limitation , this study suggests memantine lacks substantial efficacy as an augmentation treatment for major depressive disorder .


Evidence supports the role of feedback in reinforcing motivation for behavior change .


Feedback that provides reinforcement has the potential to increase dietary self-monitoring and enhance attainment of recommended dietary intake .


The aim of this study was to examine the impact of daily feedback ( DFB ) messages , delivered remotely , on changes in dietary intake .


This was a secondary analysis of the Self - Monitoring And Recording using Technology ( SMART ) Trial , a single-center , @-month randomized clinical trial of behavioral treatment for weight loss .


Participants included @ obese adults ( mean body mass index , @ kg/m ) who were randomized to either a paper diary ( PD ) , personal digital assistant ( PDA ) , or PDA plus daily tailored feedback messages ( PDA + FB ) .


To determine the role of daily tailored feedback in dietary intake , we compared the self-monitoring with DFB group ( DFB group ; n = @ ) with the self-monitoring without DFB group ( no-DFB group , n = @ ) .


All participants received a standard behavioral intervention for weight loss .


Self-reported changes in dietary intake were compared between the DFB and no-DFB groups and were measured at baseline and at @ , @ , @ , and @ months .


Linear mixed modeling was used to examine percentage changes in dietary intake from baseline .


Compared with the no-DFB group , the DFB group achieved a larger reduction in energy ( -@ % vs -@ % ; P = @ ) and saturated fat ( -@ % vs -@ % ; P = @ ) intake and a trend toward a greater decrease in total fat intake ( -@ % vs -@ % ; P = @ ) .


There were significant improvements over time in carbohydrate intake and total fat intake for both groups ( P values < @ ) .


Daily tailored feedback messages designed to target energy and fat intake and delivered remotely in real time using mobile devices may play an important role in the reduction of energy and fat intake .


To investigate the accelerating effects of low-intensity pulse ultrasound stimulation ( LIPUS ) on the fracture healing of distal radius .


A total of @ patients with distal radius fracture were randomly divided into two groups : the ultrasound treatment group and the control group .


Patients in the ultrasound treatment group were immobilized in a below-elbow cast and received LIPUS treatment @ min/day , while the control group were immobilized by a plaster support and cast .


The patients were followed up every week and took X-ray films .


The initial and healed X-ray films and the gray value of fracture site were analyzed by Photoshop software .


The effect of reposition was evaluated based upon Steward recommended by Dienst , combining with Aro 's measuring method .


Clinical fracture healing time in ultrasound group was significantly shorter than that in the control group ( @ @ d vs. @ @ d , p < @ ) .


In addition , the grey value changes of fracture sites of the ultrasound group were much higher than that of the control group .


The reposition effects of fracture healing had no difference between the two groups ( p > @ ) .


Low-intensity pulse ultrasound stimulation could accelerate fracture healing of the distal radius and promote local bone formation .


To determine whether clinical findings-bleeding on probing , pocket depth , recession , and bacterial sampling-correlate with histologic outcomes in relatively healthy peri-implant soft tissues in people .


In this cross-sectional study , a convenience sample of @ edentulous subjects received two endosseous mandibular implants each .


The abutments were either zirconia ( ZrO ) or titanium ( Ti ) ( nonsubmerged implant placement , within-subject comparison , leftright randomization ) .


Sulcular bacterial sampling and assessment of probing pocket depth , recession , and bleeding on probing were performed @ months postsurgery .


Mucosal biopsy specimens were obtained , and the blood vessel density and a score on an inflammation grading scale were determined .


Simple linear and linear regression models revealed that the clinical or microbiologic parameters were not associated with either of the histologic parameters .


The soft tissues impressed as healthy , regardless of the abutment material .


The peri-implant mucosa around ZrOand Ti abutments was considered healthy in most situations when examined histologically after @ months but showed variation in clinical and microbiologic parameters .


Exercise prescription in cardiac patients is based on heart rate ( HR ) response to exercise .


How to prescribe long-term exercise training outside medically-supervised settings also considering changes in individual physical capacity over time is unknown .


In this study we hypothesized that in patients with chronic heart failure ( CHF ) the session-rate of perceived exertion ( RPE ) , a subjective-based training methodology , provides autonomic and functional capacity changes superimposable to those observed with HR-based Training Impulses ( TRIMPi ) method .


Twenty patients with stable CHF were randomized to either aerobic continuous training ( ACT ) or aerobic interval training ( AIT ) for @ weeks .


For each TRIMPi-guided exercise session , the session-RPE was recorded .


By this method , internal training load ( TL ) is quantified by multiplying the RPE of the whole training session , using the Borg CR@-scale , by its duration .


Heart rate variability ( HRV ) , and baroreflex sensitivity ( BRS ) were assessed at baseline and at @ weeks intervals .


Significant correlations were found between TRIMPi and individual session-RPE , for both ACT and AIT ( r = @ to @ ) , ( P < @ ) .


The same occurred when ACT and AIT groups were pooled together ( r = @ ; P < @ ) .


R-R interval , HRV and BRS were significantly and very highly correlated with weekly RPE-session ( r ( @ ) ranged from @ to @ ; P < @ ) .


A significant relationship between session-RPE and performance at the @MWT was also found .


Session-RPE is an easy-to-use , inexpensive and valid method for exercise prescription and health maintenance , consistent with objective physiological indices of training , that could be used for long-term physical activity in patients with CHF .


Epidemiologic data suggest inverse associations between citrus flavanone intake and cardiovascular disease ( CVD ) risk .


However , insufficient randomized controlled trial data limit our understanding of the mechanisms by which flavanones and their metabolites potentially reduce cardiovascular risk factors .


We examined the effects of orange juice or a dose-matched hesperidin supplement on plasma concentrations of established and novel flavanone metabolites and their effects on cardiovascular risk biomarkers in men at moderate CVD risk .


In an acute , randomized , placebo-controlled crossover trial , @ fasted participants ( aged @-@ y ) received orange juice or a hesperidin supplement ( both providing @ mg hesperidin ) or control ( all matched for sugar and vitamin C content ) .


At baseline and @ h postintake , endothelial function ( primary outcome ) , blood pressure , arterial stiffness , cardiac autonomic function , platelet activation , and NADPH oxidase gene expression and plasma flavanone metabolites were assessed .


Before each intervention , a diet low in flavonoids , nitrate/nitrite , alcohol , and caffeine was followed , and a standardized low-flavonoid evening meal was consumed .


Orange juice intake significantly elevated mean SEM plasma concentrations of @ flavanone ( @ @ mol/L , P < @ ) and @ phenolic ( @ @ mol/L , P < @ ) metabolites compared with control at @ h postconsumption .


Despite increased plasma flavanone and phenolic metabolite concentrations , cardiovascular risk biomarkers were unaltered .


After hesperidin supplement intake , flavanone metabolites were not different from the control , suggesting altered absorption/metabolism compared with the orange juice matrix .


After single-dose flavanone intake within orange juice , circulating flavanone and phenolic metabolites collectively reached a concentration of @ @ mol/L , but no effects were observed on cardiovascular risk biomarkers .


Longer-duration randomized controlled trials are required to examine previous associations between higher flavanone intakes and improved cardiovascular health and to ascertain the relative importance of food matrix and flavanone-derived phenolic metabolites .


This trial was registered at clinicaltrials.gov as NCT@ .


Incomplete revascularization ( ICR ) after percutaneous coronary intervention ( PCI ) is common and is associated with increased rates of rehospitalization , revascularization , and mortality .


Adjunctive pharmacotherapy with ranolazine , an inhibitor of the late sodium current with anti-ischemic properties , may be effective in reducing recurrent events after PCI in patients with ICR .


RIVER-PCI is a phase @ , randomized , double-blind , placebo-controlled , international event-driven clinical trial evaluating the efficacy of ranolazine in patients with a history of chronic angina and ICR after PCI .


Approximately @,@ participants with ICR post-PCI will be randomized in a @:@ ratio to ranolazine or matched placebo within @ days of an index PCI .


The primary end point of the trial is time to the first occurrence of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization .


Participants will be followed up for a minimum of @ year and until at least @ confirmed primary end point events have occurred .


Secondary end points include sudden cardiac death , cardiovascular death , myocardial infarction , and measures of quality of life and cost-effectiveness .


The evaluation of long-term safety will include all-cause mortality , stroke , transient ischemic attack , and hospitalization for heart failure .


Enrollment commenced in November @ and was completed in summer @ .


RIVER-PCI is a novel , large-scale , international , randomized , double-blind , placebo-controlled clinical trial evaluating the role of ranolazine in the long-term medical management of patients with ICR post-PCI .


postoperative pain increases the activity of the sympathetic system , causes hypermetabolic conditions , retains salt and water , increases glucose , fatty acid lactate and oxygen consumption , weakens the immunity system which delays wound healing .


Our object was comparison of the analgesic effect of morphine and paracetamol in the patients undergoing laparotomy , using PCA method .


Seventy patients who had undergone laparotomy were studied using double blind randomized clinical trial ( @ patients received morphine and @ paracetamol ) in the Shahid Rajaee Center and Velayat Hospital ( Qazvin , Iran ) .


People using opioids , painkillers and sedatives regularly and in large doses and patients with a history of lung or liver problems did not participate in this project .


The parameters of the severity of pain and nausea ( VAS ) , hemodynamic changes ( BP and HR ) , pruritus , arterial oxygen desaturation and patient satisfaction ( VAS ) of both groups were measured by a third party ( trained colleague ) .


The data was analyzed using SPSS @ statistical software then descriptive results were extracted and ultimately the groups were compared using the following statistical tests : student 's T-test , chi @ and Fisher 's exact test ( P < @ ) .


The mean age of the participants was @ years .


Women constituted @ % of the patients and men @ % .


The average pain severity for morphine and paracetamol groups ( VAS ) was @ and @ after@ hours and reached @ and @ after @ hours ( after the operation ) respectively .


There was a significant difference between the groups after @ and @ hours in terms of pain severity ( after @ hours P = @ and after @ hours P = @ ) .


However there was no significant difference between the average pain severity of the studied groups ( after @ hours P = @ and @ hours P = @ ) .


After @ hours , the average nausea severity was the minimum in both groups being @ and @ in morphine and paracetamol groups respectively .


Nausea severity was higher after @ hours in paracetamol group .


In morphine group , it was higher after @ , @ and @ hours .


Difference between the groups was not significant .


The average satisfaction level ( VAS ) for morphine and paracetamol groups reached from @ and @ after @ hours , to @ and @ after @ hours ( after the operation ) , respectively .


The average satisfaction level of patients was higher in morphine group in @,@,@ and @ hours and except for , after @ hours ( P = @ ) , the satisfaction difference between both groups was not significant in other hours ( P = @ after @ hours , P = @ after @ hours and P = @ after @ hours )


Morphine seems to be more effective at @ and @ hours , but after @ hours they have similar effects , the satisfaction difference between both groups was not significant in the patients .


To compare the clinical outcome of platform switching ( PS ) and regular platform ( RP ) implants in bilateral single molar replacements .


This study was designed as a randomised , controlled , split-mouth trial .


Eighteen patients , with bilaterally missing single molars had one site randomly assigned to a PS implant or a RP implant .


A total of @ implants were bilaterally installed .


Both implants were loaded with screw retained temporary crowns @ months after implant insertion and with screw retained definitive crowns @ months later .


Outcome measures were implant/crown failure , complications , radiographic marginal bone-level changes , pocket probing depth ( PPD ) and bleeding on probing ( BOP ) .


Clinical data were collected at baseline @ and @ months after implant placement .


No patients dropped out and no implant failed .


No prosthetic or major biological complications were observed .


One year after implant placement , mean marginal bone level was @ @ mm ( @ % CI @ to @ ) in RP group and @ @ mm ( @ % CI @ to @ ) in the PS group and no statistically significant differences between the two groups were observed ( P = @ ) .


Mean PPD and BOP values were , @ and @ months after implant placement , @ @ mm ( @ % CI @ to @ ) and @ @ ( @ % CI @ to @ ) in the RP group , and @ @ mm ( @ % CI @ to @ ) and @ @ ( @ % CI @ to @ ) in the PS group respectively , with no statistical differences between groups ( P = @ and P = @ , respectively ) .


No statistically significant difference was observed between platform switched and non-platform switched implants .


The use of structured curricula for minimally invasive surgery training is becoming increasingly popular .


However , many laparoscopic training programs still use basic skills and isolated task training , despite increasing evidence to support the use of training models with higher functional resemblance , such as whole procedural modules .


In contrast to basic skills training , procedural training involves several cognitive skills such as elements of planning , movement integration , and how to avoid adverse events .


The objective of this trial is to investigate the specificity of procedural practice in laparoscopic simulator training .


A randomised single-centre educational superiority trial .


Participants are @ surgical novices ( medical students ) without prior laparoscopic experience .


Participants start by practicing a series of basic skills tasks to a predefined proficiency level on a virtual reality laparoscopy simulator .


Upon reaching proficiency , the participants are randomised to either the intervention group , which practices two procedures ( an appendectomy followed by a salpingectomy ) or to the control group , practicing only one procedure ( a salpingectomy ) on the simulator .


@:@ central randomisation is used and participants are stratified by sex and time to complete the basic skills .


Data collection is done at a surgical skills centre.The primary outcome is the number of repetitions required to reach a predefined proficiency level on the salpingectomy module .


The secondary outcome is the total training time to proficiency .


The improvement in motor skills and effect on cognitive load are also explored .


The results of this trial might provide new knowledge on how the technical part of surgical training curricula should be comprised in the future .


To examine the specificity of practice in procedural simulator training is of great importance in order to develop more comprehensive surgical curricula .


Although cardiac troponin is associated with outcomes in atrial fibrillation ( AF ) , the complementary prognostic information provided by cardiac troponin I ( cTnI ) and cTnT is unknown .


This study investigated the distribution , determinants , and prognostic value of cTnI and cTnT concentrations in patients with AF .


Samples were collected .


At the time of randomization , we analyzed cTnI and cTnT concentrations of @ AF patients in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ( ARISTOTLE ) trial using high-sensitivity assays .


Correlations ( Spearman ) , determinants ( multivariable linear regression ) , and outcomes ( adjusted Cox models and c-statistics ) were investigated .


Concentrations of cTnI and cTnT were correlated ( r = @ ) and measurable in most participants -LSB- cTnI @ % ( median @ ng/L , @th percentile in @ % ) and cTnT @ % ( median @ ng/L , @th percentile in @ % ) -RSB- .


Renal impairment was the most important factor affecting the concentrations of both troponins .


cTnI increase was more associated with heart failure , vascular disease , and persistent/permanent AF , and cTnT with age , male sex , and diabetes .