Investigator , subject , and dermospectrophotometer measurements were obtained .


In cohort @ , improved skin texture ( P < @ ) , roughness ( P < @ ) , and overall appearance ( P = @ ) was noted at week @ with lignin peroxidase versus no treatment .


By week @ , there was a decrease in spot size with lignin peroxidase versus no treatment ( P = @ ) .


This was confirmed by a statistically significant reduction in melanin scores with the dermospectrophotometer on lignin peroxidase-treated side at weeks @ , @ , and @ ( P = @ ) and a similar reduction in Melasma Area Severity Index score .


Cohort @ demonstrated parity between lignin peroxidase and hydroquinone , but lignin peroxidase was statistically superior in skin texture and roughness .


The sample size was limited .


Lignin peroxidase might be an over-the-counter skin-lightening preparation with efficacy parity to hydroquinone .


Increasing evidence suggests that stromal monocarboxylate transporter @ ( MCT@ ) and carbonic anhydrase IX ( CA IX ) may play key roles in tumor development .


However , their clinical value remains largely unexplored in gastric cancer ( GC ) .


The present study aimed to determine clinicopathological significance and prognostic values of stromal MCT@ and CA IX in GC .


Specimens from @ GC patients were immunohistochemically stained using polyclonal anti-MCT@ and anti-CA IX antibodies .


Expression was correlated with patient clinicopathologic characteristics and survival data .


High stromal MCT@ expression was detected in @ of @ ( @ % ) GCs and high CA IX in @ ( @ % ) .


Both high stromal MCT@ and CA IX were correlated with advanced TNM stage ( p = @ ; p = @ ) .


High CA IX expression was positively related to depth of invasion ( p = @ ) and positive lymph nodes ( p = @ ) as well .


Survival analysis indicated high expression of stromal MCT@ to be an independent factor in predicting poor overall survival ( OS ) ( HR and @ % CI = @ , @-@ @ , p = @ ) and disease free survival ( DFS ) ( HR and @ % CI = @ , @-@ @ , p = @ ) of GC patients .


However , high CA IX expression exhibited no significant predictive value .


These findings suggest that high expression of stromal MCT@ and CA IX proteins is significantly correlated with GC progression .


High stromal MCT@ heralds worse outcome of GC patient , suggesting a novel candidate prognostic marker and therapeutic target .


To study the prevalence of H. pylori CagA strain and the activity of associated gastritis in schoolchildren of Tyva Republic ( Russia ) .


The cohorts had been formed out of @ native and alien schoolchildren picked up by random in Tyva Republic in the ages from @ to @ years .


We determined IgG to H. pylori CagA antigen in serum ( @ aliens and @ natives ) .


Out them @ Tuvins and @ Europoids with dyspeptic complaints were provided with endoscopic tests including biopsy of mucosa of antrum and stomach body .


We had found ethnic peculiarities in the obtained indices in children , namely higher prevalence of the said strain of H. pylori and the absence of meaningful activity in antral sector and body of stomach in CagA-seropositive native children as compared to alien ones , in whom the activity of antral gastritis was higher than the activity in body of stomach .


To compare isoflurane and propofol for maintenance of anesthesia and quality of recovery in client-owned dogs with intracranial disease undergoing magnetic resonance imaging ( MRI ) .


Prospective , randomized , clinical trial .


Twenty-five client-owned dogs with intracranial pathology , @ females and @ males , ages @months to @years , weighing between @ and @ kg .


Each dog was randomly assigned to receive propofol or isoflurane for maintenance of anesthesia .


All dogs were not premedicated , were administered propofol intravenously to effect for induction , intubated and mechanically ventilated to maintain an end-tidal carbon dioxide tension @-@mmHg ( @-@ @ kPa ) .


Temperature and cardiac output were measured pre - and post-MRI .


Scores for mentation , neurological status , ease of maintenance , and recovery were obtained pre - and post-anesthesia .


Pulse oximetry , end-tidal gases , arterial blood pressure , heart rate ( HR ) and requirements for dopamine administration to maintain mean arterial pressure ( MAP ) > @mmHg were recorded throughout anesthesia .


End-tidal isoflurane concentration was @ % and propofol infusion rate was @gkg ( -@ ) minute ( -@ ) .


Cardiac index was higher , while HR was lower , with propofol than isoflurane in dogs younger than @years , but not in older dogs .


Dogs maintained with isoflurane were @ times more likely to require dopamine than propofol dogs .


Mentation and maintenance scores and temperature were not different .


MAP and diastolic arterial pressure were higher in the propofol group .


Recovery scores were better with propofol , although times to extubation were similar .


Change in neurological score from pre - to post-anesthesia was not different between treatments .


Dogs maintained with propofol during MRI had higher arterial pressures , decreased requirements for dopamine , and better recovery scores , compared to dogs maintained with isoflurane .


Propofol anesthesia offered cardiovascular and recovery advantages over isoflurane during MRI in dogs with intracranial disease in this study .


This study reported on correlates of parental perception of their child 's weight status .


Associations between parental misperception ( i.e. , underestimation of the child 's weight ) and parental intention to improve their child 's overweight-related health behaviors and their child meeting guidelines regarding these behaviors were also investigated .


Baseline data from the population-based ` Be active , eat right study ' were used .


The population for analysis consisted of @ overweight and @ obese five year-old children and their parents .


Questionnaires were used to measure parental perception of the child 's weight status , correlates of misperception ( i.e. , child age , child gender , child BMI , parental age , parental gender , parental country of birth , parental educational level and parental weight status ) , overweight-related health behaviors ( i.e. , child playing outside , having breakfast , drinking sweet beverages , and watching TV ) , and parental intention to improve these behaviors .


Height and weight were measured using standardized protocols .


Multivariable logistic regression analyses were performed .


In total , @ % of the parents misperceived their child 's weight status .


Parental misperception was associated with lower child BMI , the parent being the father , a foreign parental country of birth , and a lower parental education level ( p < @ ) .


Parental misperception was not associated with parental intention to improve child overweight-related health behavior , nor with child meeting the guidelines of these behaviors .


This study showed that almost half of the parents with an overweight or obese child misperceived their child 's weight status .


A correct parental perception may be a small stepping-stone in improving the health of overweight and obese children .


To assess the beneficial effects of the components of lifestyle intervention in reducing incidence of diabetes in Asian Indian men with impaired glucose tolerance ( IGT ) in India .


This analysis was based on a @ year prospective , randomized controlled primary prevention trial in a cohort of Asian Indian men with IGT ( n = @ ) ( Clinical Trial No : NCT@ ) .


Intervention and control groups were given standard care advice at baseline .


Additionally , the intervention group received frequent , mobile phone based text message reminders on healthy lifestyle principles .


Dietary intake and physical activity habits were recorded by validated questionnaires .


The lifestyle goals were : reductions in consumption of carbohydrates , oil , portion size and body mass index of at least @ unit ( @ kg/m ( @ ) ) from baseline and maintenance of good physical activity .


The association between diabetes and lifestyle goals achieved was assessed using multiple logistic regression analyses .


Changes in insulin sensitivity ( Matsuda 's insulin sensitivity index ) and oral disposition index during the follow-up were assessed .


At the end of the study , @ ( @ % ) participants developed diabetes .


The mean lifestyle score was higher in the intervention group compared with control ( @ @ vs. @ @ ; P = @ ) .


Among the @ lifestyle variables , significant improvements in the @ dietary goal were seen with intervention .


Concomitant improvement in insulin sensitivity and oral disposition index was noted .


Higher lifestyle score was associated with lower risk of developing diabetes ( odds ratio : @ -LSB- @ % CI : @-@ @ -RSB- ; P < @ ) .


Beneficial effects of intervention were associated with increased compliance to lifestyle goals .


The plausible mechanism is through improvement in insulin sensitivity and beta cell preservation .


To investigate the safety and efficay of low-dose furosemide in the correction of oliguria in the patients undergoing gynecologic surgery .


A total of @ patients , aged between @ to @ years old , who were scheduled to receive elective gynecological open surgery under general anesthesia , were randomly divided into @ groups : the control group , furosemide @ mg/kg ( F@ @ ) group and furosemide @ mg/kg ( F@ ) group ( n = @ ) .


During surgery , blood volume and blood pressure was maintained in the normal range .


The urine volume was recorded every @ minutes .


Oliguria was defined as the urine volume less than @ mL / ( kg .


h ) , When oliguria was observed , flurosemide or saline was given to the patients based on the enrollment status .


If the patients were still oliguric @ min later , the treatment was repeated .


The total time of surgery , net fluid infusion volume , urine volume per unit time per body weight at the completion of surgery , the incidence of intraoperative oliguria , the total amount of furosemide and the average specific gravity of urine were recorded .


There was no statistically significant difference in sex , age , fasting time , the total time of surgery and intraoperative net fluid infusion volume among the three groups ( P > @ ) .


The urine volume per unit time per body weight in control group was significantly lower than that of the other two groups ( P < @ ) .


The incidence of intraoperative oliguria in the three groups ( control , low dose , high dose groups ) were @ % , @ % and @ % , respectively ( P < @ ) .


Low-dose of furosemide could maintain normal urine volume and specific gravity of urine during gynecological surgery .


Ebola virus and Marburg virus cause serious disease outbreaks with high case fatality rates .


We aimed to assess the safety and immunogenicity of two investigational DNA vaccines , one ( EBO vaccine ) encoding Ebola virus Zaire and Sudan glycoproteins and one ( MAR ) encoding Marburg virus glycoprotein .


RV @ was a phase @b , double-blinded , randomised , placebo-controlled clinical trial in Kampala , Uganda to examine the safety and immunogenicity of the EBO and MAR vaccines given individually and concomitantly .


Healthy adult volunteers aged @-@ years were randomly assigned ( @:@ ) to receive three injections of vaccine or placebo at weeks @ , @ , and @ , with vaccine allocations divided equally between three active vaccine groups : EBO vaccine only , MAR vaccine only , and both vaccines .


The primary study objective was to investigate the safety and tolerability of the vaccines , as assessed by local and systemic reactogenicity and adverse events .


We also assessed immunogenicity on the basis of antibody responses ( ELISA ) and T-cell responses ( ELISpot and intracellular cytokine staining assays ) @ weeks after the third injection .


Participants and investigators were masked to group assignment .


Analysis was based on the intention-to-treat principle .


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


@ participants were enrolled into the study between Nov @ , @ , and April @ , @ .


All @ participants received at least one study injection ( including @ who completed the injection schedule ) and were included in safety and tolerability analyses ; @ for whom data were available were included in the immunogenicity analyses .


Study injections were well tolerated , with no significant differences in local or systemic reactions between groups .


The vaccines elicited antibody and T-cell responses specific to the glycoproteins received and we detected no differences between the separate and concomitant use of the two vaccines .


@ of @ ( @ % , @ % CI @-@ ) participants in the EBO vaccine group had an antibody response to the Ebola Zaire glycoprotein , as did @ of @ ( @ % , @-@ ) in the group that received both vaccines .


@ of @ ( @ % , @-@ ) participants in the EBO vaccine group had an antibody response to the Ebola Sudan glycoprotein , as did @ of @ ( @ % , @-@ ) in the group that received both vaccines .


Nine of @ ( @ % , @-@ ) participants in the MAR vaccine groups had an antibody response to the Marburg glycoprotein , as did seven of @ ( @ % , @-@ ) in the group that received both vaccines .


@ of @ ( @ % , @-@ ) participants in the EBO vaccine group had a T-cell response to the Ebola Zaire glycoprotein , as did @ of @ ( @ % , @-@ ) in the group that received both vaccines .


@ of @ ( @ % , @-@ ) participants in the EBO vaccine group had a T-cell response to the Ebola Sudan glycoprotein , as did @ of @ ( @ % , @-@ ) in the group that received both vaccines .


@ of @ ( @ % , @-@ ) participants in the MAR vaccine group had a T-cell response to the Marburg glycoprotein , as did @ of @ ( @ % , @-@ ) in the group that received both vaccines .


This study is the first Ebola or Marburg vaccine trial done in Africa , and the results show that , given separately or together , both vaccines were well tolerated and elicited antigen-specific humoral and cellular immune responses .


These findings have contributed to the accelerated development of more potent Ebola virus vaccines that encode the same wild-type glycoprotein antigens as the EBO vaccine , which are being assessed during the @ Ebola virus disease outbreak in west Africa .


Cure of lung cancer is impossible without local tumour control .


This can be compromised by accelerated repopulation of tumour cells during radiotherapy and chemotherapy .


A strategy to minimise accelerated repopulation might improve local control .


We investigated whether concurrent chemo-radiotherapy could be given safely over four weeks .


We conducted a randomised phase II trial in which patients with inoperable Stage III Non-Small Cell Lung Cancer ( NSCLC ) received a radical radiation dose over four weeks rather than conventional fractionation .


Treatment was given either sequentially or concurrently with three to four cycles of cisplatinum and vinorelbine .


@ patients with inoperable stage III NSCLC and PS @-@ were randomised to receive cisplatinum and vinorelbine with either sequential or concurrent chemo-radiation using @Gy in @ fractions over four weeks .


The primary end-point was treatment related mortality .


Secondary end-points were toxicity and survival .


Treatment related mortality was : @ % ( exact @ % confidence interval -LSB- CI -RSB- @-@ @ % ) and @ % ( exact @ % CI @-@ @ % ) for the Concurrent and Sequential group respectively ; relative risk ( RR ) @ ; ( @ % CI @ , @ ) .


Toxicity was similar between arms ; grade @ or worse oesophagitis was @ % versus @ % ; RR @ ( @ % CI @ , @ ) .


OS HR was @ ; @ % CI ( @-@ @ ; p = @ ) .


The @ year overall survival rates were : @ % versus @ % ; RR @ ( @ % CI @ , @ ) for Concurrent versus Sequential .


A strategy to minimise the effects of accelerated repopulation using accelerated hypofractionated radiotherapy with chemotherapy is feasible , and reasonably safe for patients with stage III NSCLC .


The reported two year survival is promising and suggests that a four week regime of radiotherapy should be compared with conventionally fractionated radiotherapy in an adequately powered randomised controlled phase III trial .


In this paper , we describe a trial protocol used to assess feasibility related to : study administration ( recruitment , randomization , retention , compliance , eligibility criteria , suitability of protocol instructions and data collection questionnaires ) ; resource and data management ( suitability of site , time and budget allocation , management of personnel and data ) ; intervention fidelity ( treatment dose , violations ) ; and effect size .


Pressure injury can lead to increases in hospital length of stay and cost .


The sacrum is identified as one of the most common anatomical pressure injury sites for hospitalized patients .


Silicone foam border dressings have been proposed as one strategy to reduce pressure injury incidence ; however , rigorous testing of benefit in a general medical-surgical population is required .


Randomized controlled trial .


Eighty patients will be recruited after assessment of high risk of pressure injury in a large tertiary hospital in south-east Queensland , Australia .


Eligible , consenting participants will be randomly allocated to either a control group ( routine care ) or an intervention group ( routine care and a sacral prophylactic dressing ) .


The primary outcomes comprise feasibility criteria as identified above .


The secondary measure is the presence and severity of sacral pressure injury via blind assessment of digital photographs .


Research ethics approval was received in October @ .


Prophylactic dressings applied to the sacrum may be an effective method for reducing pressure injury in high-risk general medical-surgical patients .


However , more rigorous studies to confirm benefit are required .


This pilot study will determine the feasibility and effect size to inform a larger randomized controlled trial .


Group cognitive behavioural intervention ( CBI ) is effective in reducing low-back pain and disability in comparison to advice in primary care .


The aim of this analysis was to investigate the impact of compliance on estimates of treatment effect and to identify factors associated with compliance .


In this multicentre trial , @ adults with troublesome sub-acute or chronic low-back pain were recruited from @ general practices .


Participants were randomised to advice ( control n = @ ) or advice plus CBI ( n = @ ) .


Compliance was specified a priori as attending a minimum of three group sessions and the individual assessment .


We estimated the complier average causal effect ( CACE ) of treatment .


Comparison of the CACE estimate of the mean treatment difference to the intention-to-treat ( ITT ) estimate at @ months showed a greater benefit of CBI amongst participants compliant with treatment on the Roland Morris Questionnaire ( CACE : @ points , @ % CI @ to @ ; ITT : @ points , @ % CI @ to @ ) , the Modified Von Korff disability score ( CACE : @ points , @ % CI @ to @ ; ITT : @ points , @ % CI @ to @ ) and the Modified von Korff pain score ( CACE : @ points , @ % CI @ to @ ; ITT : @ points , @ % CI @ to @ ) .


People who were non-compliant were younger and had higher pain scores at randomisation .


Treatment compliance is important in the effectiveness of group CBI .


Younger people and those with more pain are at greater risk of non-compliance .


The use of proton pump inhibitors or misoprostol is known to prevent the gastrointestinal complications of nonsteroidal anti-inflammatory drugs ( NSAIDs ) .


Rebamipide is known to increase the mucosal generation of prostaglandins and to eliminate free oxygen radicals , thus enhancing the protective function of the gastric mucosa .


However , it is unknown whether rebamipide plays a role in preventing NSAID-induced gastropathy .


The aim of this study was to determine the effectiveness of rebamipide compared to misoprostol in preventing NSAID-induced gastrointestinal complications in patients requiring continuous NSAID treatment .


We studied @ patients who required continuous NSAID treatment .


The patients were randomly assigned to groups that received @ mg of rebamipide three times per day or @ g of misoprostol three times per day for @ weeks .


The primary endpoint of the analysis was the occurrence rate of gastric ulcers , as determined by endoscopy after @ weeks of therapy .


Of the @ patients in the study , @ received rebamipide , and @ received misoprostol .


Ultimately , @ patients ( @ % ) withdrew from the misoprostol group and @ patients ( @ % ) withdrew from the rebamipide group .


There was a significant difference in withdrawal rate between the two groups ( p = @ ) .


The per protocol analysis set was not valid because of the dropout rate of the misoprostol group ; thus , the intention to treat ( ITT ) analysis set is the main set for the efficacy analysis in this study .


After @ weeks , the occurrence rate of gastric ulcers was similar in the rebamipide and misoprostol groups ( @ % vs @ % , p = @ ) according to ITT analysis .


In addition , the therapeutic failure rate was similar in the rebamipide and misoprostol groups ( @ % vs @ % , p = @ ) .


The total severity score of the gastrointestinal symptoms was significantly lower in the rebamipide group than in the misoprostol group ( p = @ ) .


The amount of antacid used was significantly lower in the rebamipide group than in the misoprostol group ( p = @ ) .


Rebamipide can prevent gastric ulcers when used with NSAIDs and can decrease the gastrointestinal symptoms associated with NSAID administration .


When the possibility of poor compliance and the potential adverse effects of misoprostol are considered , rebamipide appears to be a clinically effective and safe alternative .


The purpose of this study was to evaluate the efficacy and safety of duloxetine flexible dose in children ( @-@ years ) and adolescents ( @-@ years ) with major depressive disorder ( MDD ) .


Patients ( n = @ ) in this @ week study ( @ week acute and @ week extension treatment ) received duloxetine ( @-@mg once daily -LSB- QD -RSB- , n = @ ) , fluoxetine ( @-@mg QD , n = @ ) , or placebo ( n = @ ) .


Measures included : Children 's Depression Rating Scale-Revised ( CDRS-R ) , treatment-emergent adverse events ( TEAEs ) , and Columbia-Suicide Severity Rating Scale ( C-SSRS ) .


Neither active drug ( duloxetine or fluoxetine ) separated significantly ( p < @ ) from placebo on mean change from baseline to end-point ( @ weeks ) on the CDRS-R total score .


There were no significant differences between the duloxetine or fluoxetine groups compared with placebo on serious AEs ( SAEs ) , total TEAEs , or discontinuation for AE during acute treatment .


There were no completed suicides or deaths , and no clinically significant electrocardiogram ( ECG ) abnormalities observed during the study .


One fluoxetine and one duloxetine patient experienced alanine aminotransferase ( ALT ) three or more times the upper limit of normal , which resolved during the study .


A total of @ ( @ % ) duloxetine patients , @ ( @ % ) placebo patients , and @ ( @ % ) fluoxetine patients had worsening of suicidal ideation from baseline during acute treatment .


Of the patients with suicidal ideation at baseline , @/@ ( @ % ) duloxetine , @/@ ( @ % ) placebo , and @/@ ( @ % ) fluoxetine had improvement in suicidal ideation at end-point during acute treatment .


One duloxetine and two fluoxetine patients had treatment-emergent suicidal behavior during the @ week study .


Trial results were inconclusive , as neither the investigational drug ( duloxetine ) nor the active control ( fluoxetine ) separated from placebo on the CDRS-R at @ weeks .


No new duloxetine safety signals were identified relative to those seen in adults .


Clinical Trial Registry Number : NCT@ .


The @ Eighth Joint National Committee panel recommendations for management of high blood pressure ( BP ) recommend a systolic BP threshold for initiation of drug therapy and a therapeutic target of < @ mm Hg in those@ years of age , a departure from prior recommendations of < @ mm Hg .


However , it is not known whether this is an optimal choice , especially for the large population with coronary artery disease ( CAD ) .


This study sought to evaluate optimal BP in patients@ years of age .


Patients @ years of age or older with CAD and baseline systolic BP > @ mm Hg randomized to a treatment strategy on the basis of either atenolol/hydrochlorothiazide or verapamil-SR ( sustained release ) / trandolapril in INVEST ( INternational VErapamil SR Trandolapril STudy ) were categorized into @ groups on the basis of achieved on-treatment systolic BP : group @ , < @ mm Hg ; group @ , @ to < @ mm Hg ; and group @,@ mm Hg .


Primary outcome was first occurrence of all-cause death , nonfatal myocardial infarction ( MI ) , or nonfatal stroke .


Secondary outcomes were all-cause mortality , cardiovascular mortality , total MI , nonfatal MI , total stroke , nonfatal stroke , heart failure , or revascularization , tabulated separately .


Outcomes for each group were compared in unadjusted and multiple propensity score-adjusted models .


Among @,@ patients included in this analysis with an accumulated @,@ patient-years of follow-up , @,@ ( @ % ) achieved systolic BP of < @ mm Hg ( group @ ) , @,@ ( @ % ) achieved systolic BP of @ to < @ mm Hg ( group @ ) , and @,@ ( @ % ) achieved systolic BP of@ mm Hg ( group @ ) .


In unadjusted models , group @ had the lowest rates of the primary outcome ( @ % vs. @ % vs. @ % ; p < @ ) , all-cause mortality ( @ % vs. @ % vs. @ % ; p < @ ) , cardiovascular mortality ( @ % vs. @ % vs. @ % ; p < @ ) , MI ( @ % vs. @ % vs. @ % ; p < @ ) , total stroke ( @ % vs. @ % vs. @ % ; p < @ ) , and nonfatal stroke ( @ % vs @ % vs @ % ; p < @ ) compared with groups @ and @ , respectively .


In multiple propensity score-adjusted models , compared with the reference group of < @ mm Hg ( group @ ) , the risk of cardiovascular mortality ( adjusted hazard ratio -LSB- HR -RSB- : @ ; @ % confidence interval -LSB- CI -RSB- : @ to @ ; p = @ ) , total stroke ( adjusted HR : @ ; @ % CI : @ to @ ; p = @ ) and nonfatal stroke ( adjusted HR : @ ; @ % CI : @ to @ ; p = @ ) was increased in the group with BP of @ to < @ mm Hg , whereas the risk of primary outcome , all-cause mortality , cardiovascular mortality , total MI , nonfatal MI , total stroke , and nonfatal stroke was increased in the group with BP@ mm Hg .


In hypertensive patients with CAD who are@ years of age , achieving a BP target of @ to < @mm Hg as recommended by the JNC-@ panel was associated with less benefit than the previously recommended target of < @ mm Hg .


After cardiac surgery , patients receive large amounts of fluid in the Intensive Care Unit ( ICU ) .


We plan to conduct a multi-centre randomised controlled trial , of a conservative fluid regime , in patients after cardiac surgery , and have reported results of a feasibility study that evaluated efficacy and safety of the proposed regime .


After ethical approval , a single-centre , prospectively randomised interventional study was undertaken .


Participants were randomised to either usual care , or to a protocolised algorithm , utilising stroke volume variation , to guide fluid administration to patients who were deemed to have inadequate cardiac output and were likely to be volume responsive .


The study protocol lasted from ICU admission to de-sedation or @ h , whichever occurred first .


We randomised @ subjects over @ months .


Less bolus fluid and less total overall fluid volume was administered in the intervention group ( median ( IQR ) @ ml ( @-@ ) and @ ml ( @-@ ; P < @ ) , compared with the usual care group ( @ ml ( @-@ ) and @ ml ( @-@ ; P = @ ) , from ICU admission to extubation .


There was no significant difference in incidence of acute kidney injury or the average amount of fluid administered to the usual care group at the beginning compared with the end of the study .


It is both possible and safe to achieve a significant reduction in the amount of fluid administered to patients , allocated to a conservative fluid protocol .


These results suggest that a planned multi-centre study is both justified and feasible .


Dexmedetomidine can prolong the duration of local anesthetics , but the effect of retrobulbar dexmedetomidine on the potency of ropivacaine for retrobulbar block has not been investigated .


Our study was designed to determine the effect of retrobulbar dexmedetomidine on ropivacaine for retrobulbar block in children .


A group of @ children aged @-@ years scheduled for vitreoretinal surgery who received retrobulbar block were randomly assigned to @ of @ groups : group L ( retrobulbar ropivacaine ) , group LD@ ( ropivacaine plus @ g.kg-@ dexmedetomidine ) , or group LD@ ( ropivacaine plus @ g.kg-@ dexmedetomidine ) .


The minimum local anesthetic concentration ( MLAC ) was determined according to a Dixon-Massey protocol .


The primary endpoint of the study was MLAC .


Secondary outcomes were duration of postoperative analgesia , postoperative pain scores , dexmedetomidine side effects , and time to hospital discharge .


The MLAC values of retrobulbar ropivacaine were @ % , @ % , and @ % in groups L , LD@ , and LD@ , respectively .


The median ( interquartile range ) durations of analgesia in the postoperative period were @ ( @-@ ) , @ ( @-@ ) , and @ ( @-@ ) minutes in groups L , LD@ , and LD@ , respectively ( L vs LD@ or LD@ , p < @ ) .


Wake-up time was significantly increased in groups LD@ and LD@ .


Retrobulbar dexmedetomidine reduces the MLAC values of ropivacaine and improves postoperative analgesia in children without any neurologic side effects .


Empathy improves our ability to communicate in social interactions and motivates prosocial behavior .


The neuropeptides arginine vasopressin and oxytocin play key roles in socioemotional processes such as pair bonding and parental care , which suggests that they may be involved in empathic processing .


We investigated how vasopressin and oxytocin affect empathic responding in a randomized , double-blind , placebo controlled , between-subjects study design .


We also examined the moderating role of parental warmth , as reported in the early family environment , on empathic responding following vasopressin , oxytocin , or placebo administration .


Among participants who reported higher levels of paternal warmth ( but not maternal warmth ) , vasopressin ( vs. placebo and oxytocin ) increased ratings of empathic concern after viewing distressing and uplifting videos .


No main or interaction effects were found for individuals who received oxytocin .


Vasopressin has a role in enhancing empathy among individuals who received higher levels of paternal warmth .


Levels of stool fatty acid soaps and beneficial bacteria differ between formula-fed and breast-fed infants ; addition of specific formula ingredients may reduce these differences .


This study evaluated the effects of a term infant formula containing high sn-@ palmitate term infant formula ( sn-@ ) or an identical formula supplemented with oligofructose ( OF ) at @ concentrations ( sn-@ +@ g/L OF , sn-@ +@ g/L OF ) on stool composition , stool characteristics , and fecal bifidobacteria .


Healthy , term formula-fed infants @ to @ days old ( n = @ ) were randomized in a double-blind manner to receive standard formula ( control ) , sn-@ , sn-@ +@ g/L OF , or sn-@ +@ g/L OF for @ weeks .


Human milk ( HM ) - fed infants ( n = @ ) were studied in parallel .


Stool samples were collected from all subjects at week @ for fatty acid soaps and mineral content , and from a subset at baseline and week @ for bifidobacteria .


Stool characteristics were assessed via @-day diary .


The sn-@ group had @ % less stool soap palmitate ( P < @ ) and softer stools than control ( @ % more mushy soft stools , P = @ ; @ % fewer formed stools , P = @ ) .


Addition of OF resulted in even fewer formed stools versus control ( @ % fewer for sn-@ +@ g/L OF , @ % fewer for sn-@ +@ g/L OF ) , with @ g/L OF more closely resembling that of HM-fed infants .


Both sn-@ ( P < @ ) and sn-@ with OF groups ( P < @ ) had significantly higher fecal bifidobacteria concentrations than control at week @ , not differing from HM-fed infants .


High sn-@-palmitate formulas led to reduced stool soaps , softer stools , and increased bifidobacteria , whereas addition of OF further improved stool consistency .


Those modifications brought outcomes in formula-fed infants closer to that in HM-fed infants .


Targeting the epidermal-growth-factor-receptor ( EGFR ) in non-small cell lung cancer ( NSCLC ) is an established treatment option with less toxicity compared to conventional chemotherapy .


This study was undertaken to determine whether Erlotinib is non-inferior compared to chemotherapy as a first-line therapy in unselected elderly patients .


Patients @ years with untreated , metastatic NSCLC were randomized to Erlotinib ( E ) , @ mg/day or Carboplatin ( AUC@ ) plus Vinorelbine ( @mg/m ( @ ) on days @ and @ ) every three weeks ( CV ) .


Primary endpoint was progression-free survival ( PFS ) .


After progression , crossover was strongly recommended .


Secondary endpoints were duration of response , @-year survival , overall survival ( OS ) , response rate ( RR ) , quality of life ( FACT-L ) , assessment of comorbidities by simplified comorbidity score ( SCS ) and Charlsons ' comorbidity score , safety and assessment of molecular markers .


Between June @ and August @ @ pts were randomized to E ( @ ) and CV ( @ ) .


PFS was significantly inferior with E ( median PFS @ versus @ months -LSB- HR @ , @ % CI @-@ @ , p : @ -RSB- ) as well as RR ( @ % v @ % , p : @ ) .


No significant difference in OS appeared ( median E : @ months versus CV : @ months , HR : @ -LSB- @ % CI @-@ @ -RSB- ) .


In never smokers PFS ( median PFS : @ v @ m , E v CV , HR @ , @ % CI @-@ @ ) and OS ( median : @ versus @ months , HR @ -LSB- @ % CI @-@ @ -RSB- ) were comparable .


More skin toxicity and diarrhea was seen with E compared to more myelotoxicity , neurotoxicity and constipation with CV .


Less severe adverse events were observed with E ( @ v @ , E v CV ) .


CV had an increased efficacy compared with E in an unselected population of elderly patients with advanced NSCLC .


In the BRIM-@ trial , vemurafenib was associated with risk reduction versus dacarbazine of both death and progression in patients with advanced BRAF ( V@ ) mutation-positive melanoma .


We present an extended follow-up analysis of the total population and in the BRAF ( V@E ) and BRAF ( V@K ) mutation subgroups .


Patients older than @ years , with treatment-naive metastatic melanoma and whose tumour tissue was positive for BRAF ( V@ ) mutations were eligible .


Patients also had to have a life expectancy of at least @ months , an Eastern Cooperative Oncology Group ( ECOG ) performance status of @ or @ , and adequate haematological , hepatic , and renal function .


Patients were randomly assigned by interactive voice recognition system to receive either vemurafenib ( @ mg orally twice daily ) or dacarbazine ( @ mg/m ( @ ) of body surface area intravenously every @ weeks ) .


Coprimary endpoints were overall survival and progression-free survival , analysed in the intention-to-treat population ( n = @ ) , with data censored at crossover .


A sensitivity analysis was done .


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


@ eligible patients were enrolled from @ centres in @ countries between Jan @ , @ , and Dec @ , @ patients were randomly assigned to receive vemurafenib and @ to receive dacarbazine .


Median follow-up was @ months ( IQR @-@ ) on vemurafenib and @ months ( @-@ ) on dacarbazine .


@ ( @ % ) of the @ patients initially randomly assigned to dacarbazine crossed over from dacarbazine to vemurafenib .


Median overall survival was significantly longer in the vemurafenib group than in the dacarbazine group ( @ months -LSB- @ % CI @-@ -RSB- vs @ months -LSB- @-@ -RSB- ; hazard ratio -LSB- HR -RSB- @ -LSB- @ % CI @-@ -RSB- ; p = @ ) , as was median progression-free survival ( @ months -LSB- @ % CI @-@ -RSB- vs @ months -LSB- @-@ -RSB- ; HR @ -LSB- @ % CI @-@ -RSB- ; p < @ ) .


For the @ ( @ % ) patients with BRAF ( V@E ) disease , median overall survival in the vemurafenib group was @ months ( @ % CI @-@ ) compared with @ months ( @-@ ) in the dacarbazine group ( HR @ -LSB- @ % CI @-@ -RSB- ; p = @ ) ; median progression-free survival was @ months ( @ % CI @-@ ) and @ months ( @-@ ) , respectively ( HR @ -LSB- @ % CI @-@ -RSB- ; p < @ ) .


For the @ ( @ % ) patients with BRAF ( V@K ) disease , median overall survival in the vemurafenib group was @ months ( @ % CI @-not estimable ) compared with @ months ( @-@ ) in the dacarbazine group ( HR @ -LSB- @ % CI @-@ -RSB- ; p = @ ) ; median progression-free survival was @ months ( @ % CI @-@ ) and @ months ( @-@ ) , respectively ( HR @ -LSB- @ % CI @-@ -RSB- ; p < @ ) .


The most frequent grade @-@ events were cutaneous squamous-cell carcinoma ( @ -LSB- @ % -RSB- of @ patients ) and keratoacanthomas ( @ -LSB- @ % -RSB- ) , rash ( @ -LSB- @ % -RSB- ) , and abnormal liver function tests ( @ -LSB- @ % -RSB- ) in the vemurafenib group and neutropenia ( @ -LSB- @ % -RSB- of @ patients ) in the dacarbazine group .


Eight ( @ % ) patients in the vemurafenib group and seven ( @ % ) in the dacarbazine group had grade @ events .


Inhibition of BRAF with vemurafenib improves survival in patients with the most common BRAF ( V@E ) mutation and in patients with the less common BRAF ( V@K ) mutation .


This study investigated the effect of exposure to television food advertising on accessibility of food-related cognitions and motivation to eat .


We initially developed a word stem completion task to measure accessibility of food-related cognitions .


In two subsequent experiments , @ female undergraduate students ( Experiment @ ) and @ overweight or obese community-dwelling women ( Experiment @ ) viewed a series of television commercials advertising either food or non-food products .


They then completed the word stem task and also rated their desire to eat .


Exposure to televised food advertisements led to the completion of word stems with more food - and eating-related words in both experiments .


It also increased self-reported desire to eat , but only for overweight and obese individuals ( Experiment @ ) .


In both samples , there was a positive association between accessibility of food-related cognitions and reported desire to eat , following priming with television food advertisements .


We conclude that an increased activation of food-related cognitions may provide a mechanism for the link between food advertising and consumption .


This has implications for tackling pathological ( over ) eating .


The study aims to determine whether the route of insulin administration influences glycaemic variability and inflammatory or neurohormonal markers in patients with type @ diabetes and congestive heart failure ( CHF ) exacerbation .


Patients ( n = @ ) were randomized to intravenous ( IV ) insulin ( duration @ h ) or subcutaneous ( SQ ) insulin .


Inflammatory cytokines and markers of lipid oxidation , high-frequency heart rate variability ( n = @ ) and cardiac impedance ( pre-ejection period , n = @ ) were used to estimate parasympathetic and sympathetic tone in patients with valid cardiac data .


Glycaemic variability was measured using a continuous glucose monitor .


Mean glucose was lower ( @ vs @ mmol/L , p = @ ) , coefficient of variation was higher ( p = @ ) and glycaemic lability index was similar on day @ in the IV group compared with the SQ group , but groups were similar by day @ .


The IV group had more confirmed hypoglycaemia ( p = @ ) .


There were no differences in hospital readmission or hospital length of stay between groups .


There were no differences in CHF biomarkers , heart rate variability or pre-ejection period between groups .


Increasing log glycaemic lability index was associated with lower on-treatment pre-ejection period ( p = @ ) while increasing coefficient of variation was associated with increasing brain natriuretic peptide ( p = @ ) and paroxonase-@ ( p = @ ) .


Other univariable analyses were not significant .


There were modest , transient differences in glucose control between IV and SQ insulin in hospitalized CHF patients .


However , the analyses do not support a link between insulin route and inflammatory markers or autonomic tone .


Further study is needed to assess outcomes in hospitalized CHF patients .


New vaccines containing highly conserved Streptococcus pneumoniae proteins such as pneumolysin toxoid ( dPly ) and histidine-triad protein D ( PhtD ) are being developed to provide broader protection against pneumococcal disease .


This study evaluated the safety , reactogenicity and immunogenicity of different pneumococcal protein-containing formulations in adults .


In a phase I double-blind study ( www.clinicaltrials.gov : NCT@ ) , healthy adults ( @-@ years ) were randomized ( @:@:@:@:@:@:@ ) to receive two doses of one of six investigational vaccine formulations @ months apart , or a single dose of the control @-valent pneumococcal polysaccharide vaccine ( @PPV ; Pneumovax@ , Sanofi Pasteur MSD ) followed by placebo .


The investigational formulations contained dPly alone ( @ or @ g ) , or both dPly and PhtD ( @ or @ g each ) alone or combined with the polysaccharide conjugates of the @-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine ( PHiD-CV ; Synflorix , GlaxoSmithKline Vaccines ) .


Two groups primed with a formulation containing dPly and PhtD ( @ or @ g each ) continued to the follow-up phase II study ( NCT@ ) , in which they received a booster dose at @-@ months after primary vaccination .


Of @ enrolled and vaccinated adults , @ completed the primary immunization and @ adults received a booster dose .


During primary and booster vaccination , for any formulation , @ % of doses were followed by grade @ solicited local or general adverse events .


No fever > @ C ( oral temperature ) was reported .


Unsolicited adverse events considered causally related to vaccination were reported following @ % of investigational vaccine doses .


No serious adverse events were reported for adults receiving investigational vaccine formulations .


Formulations containing dPly with or without PhtD were immunogenic for these antigens ; polysaccharide conjugate-containing formulations were also immunogenic for those @ polysaccharides .


Investigational vaccine formulations containing dPly and PhtD were well tolerated and immunogenic when administered to healthy adults as standalone protein vaccine or combined with PHiD-CV conjugates .


Early identification ( EI ) and brief interventions ( BIs ) for risky drinkers are effective tools in primary care .


Lack of time in daily practice has been identified as one of the main barriers to implementation of BI .


There is growing evidence that facilitated access by primary healthcare professionals ( PHCPs ) to a web-based BI can be a time-saving alternative to standard face-to-face BIs , but there is as yet no evidence about the effectiveness of this approach relative to conventional BI .


The main aim of this study is to test non-inferiority of facilitation to a web-based BI for risky drinkers delivered by PHCP against face-to-face BI .


A randomised controlled non-inferiority trial comparing both interventions will be performed in primary care health centres in Catalonia , Spain .


Unselected adult patients attending participating centres will be given a leaflet inviting them to log on to a website to complete the Alcohol Use Disorders Identification Test ( AUDIT-C ) alcohol screening questionnaire .


Participants with positive results will be requested online to complete a trial module including consent , baseline assessment and randomisation to either face-to-face BI by the practitioner or BI via the alcohol reduction website .


Follow-up assessment of risky drinking will be undertaken online at @ months and @ year using the full AUDIT and D@-EQD@ scale .


Proportions of risky drinkers in each group will be calculated and non-inferiority assessed against a specified margin of @ % .


Assuming reduction of @ % of risky drinkers receiving standard intervention , @ patients will be required to give @ % power to reject the null hypothesis .


The hyperglycemic response to surgery may be a risk factor for cognitive dysfunction .


We hypothesize that strict maintenance of normoglycemia during cardiac surgery preserves postoperative cognitive function .


As part of a larger randomized , single-blind , interventional efficacy study on the effects of hyperinsulinemic glucose control in cardiac surgery ( NCT@ ) , consenting patients were randomly assigned to receive combined administration of insulin and glucose , titrated to preserve normoglycemia ( @-@ @ mmol L ( -@ ) ; experimental group ) , or standard metabolic care ( blood glucose @-@ mmol L ( -@ ) ; control group ) , during open heart surgery .


The patients ' cognitive function was assessed during three home visits , approximately two weeks before the operation , and two months and seven months after surgery .


The following tests were performed : Rey Auditory Verbal Learning Task ( RAVLT for verbal learning and memory ) , Digit Span Task ( working memory ) , Trail Making A & B ( visuomotor tracking and attention ) , and the Word Pair Task ( implicit memory ) .


Questionnaires measuring specific traits known to affect cognitive performance , such as self-esteem , depression , chronic stress and social support , were also administered .


The primary outcome was to assess the effect of hyperinsulinemic-normoglycemic clamp therapy versus standard therapy on specific cognitive parameters in patients receiving normoglycemic clamp , or standard metabolic care .


Twenty-six patients completed the study with @ patients in the normoglycemia and @ patients in the control group .


Multiple analysis of covariance ( MANCOVA ) for the RAVLT showed a significant effect for the interaction of group by visit ( F = @ , p = @ ) , and group by visit by recall ( F = @ , p = @ ) .


The differences occurred at the second and third visit .


MANCOVA for the digit span task , trail making and word pair association test showed no significant effect .


Preserving intraoperative normoglycemia by intravenous insulin and glucose may prevent the impairment of memory function , both short and long-term , after cardiac surgery .


Cardiovascular disease and cancer are leading causes of mortality for people with a history of alcohol or other substance use disorders .


These chronic diseases share the same four primary behavioural risk factors i.e. excessive alcohol use , smoking , low intake of fruit and vegetables and physical inactivity .


In addition to addressing problematic alcohol use , there is the potential for substance abuse treatment services to also address these other behaviours .


Healthy Recovery is an @-session group-based intervention that targets these multiple behavioural health risk factors and was developed specifically for people attending substance abuse treatment .


This protocol describes a Cancer Institute NSW funded study that assesses the effectiveness of delivering Healthy Recovery for people who are attending residential alcohol and other substance abuse treatment .


The study uses a stepped wedge randomised controlled design , where randomisation occurs at the service level .


Participants will be recruited from residential rehabilitation programs provided by The Australian Salvation Army .


All participants who ( @ ) currently smoke tobacco and ( @ ) are expected to be in the residential program for the duration of the @-week intervention will be asked to participate in the study .


Those participants residing at the facilities assigned to the treatment condition will complete Healthy Recovery .


The intervention is manual guided and will be delivered over a @-week period , with participants attending @ group sessions .


All participants will continue to complete The Salvation Army residential program , a predominantly @-step based , modified therapeutic community .


Participants in the control condition will complete treatment as usual .


Research staff blind to treatment allocation will complete the primary and secondary outcome assessments at baseline and then at weeks @ , @ and @ weeks post intervention .


This study will provide comprehensive data on the effect of delivering a healthy lifestyle intervention ( i.e. Healthy Recovery ) within a residential substance abuse setting .


If shown to be effective , this intervention can be disseminated within other residential substance abuse programs .


Appropriate pain management may positively affect outcome following hip fractures .


Positioning patients for spinal anesthesia ( SA ) can be extremely painful .


Peripheral nerve blockades are gaining popularity in this setting .


This prospective , randomized study compares the efficacy of fascia iliaca compartment block ( FICB ) to intravenous ( IV ) fentanyl for positioning hip fracture patients for SA .


Forty-one patients scheduled for hip fracture surgery were randomized to receive a bolus dose of IV fentanyl ( IVFE ) @ g/kg ( IVFE group ) or an FICB using @ mL ropivacaine @ % ( FICB group ) @ or @ minutes before positioning for SA , respectively .


Numeric rating pain scale scores before and following the analgesic intervention , time needed and quality of patient position for SA performance , postoperative analgesia in terms of time to first IV morphine dose demand and morphine consumption during the first @ hours , and patient satisfaction were documented .


Compared with the IVFE group , the FICB group showed significantly lower numeric rating pain scale scores in all instances following the analgesic intervention ( P < @ ) , shorter spinal performance time ( P = @ ) , and better quality of position ( P = @ ) .


Postoperative morphine consumption was lower ( P = @ ) , the time to first dose demand was longer ( P = @ ) , and patient satisfaction rates were higher ( P < @ ) in the FICB group .


Performing an FICB before positioning for SA provides superior pain management compared with IVFE administration , facilitates spinal performance , and yields satisfactory postoperative analgesia and wide patient acceptance , hence improving overall quality and efficiency of care .


To determine the psychometric properties of an observational scale of anxiety .


A cross-sectional and longitudinal survey with stroke survivor-carer dyads .


Eighty-nine dyads recruited in community stroke groups completed : a demographic questionnaire ; the Behavioural Outcomes of Anxiety scale ( BOA ) , survivor-rated ( survivor BOA ) and carer-rated ( carer BOA ) versions ; the anxiety scale of the Hospital Anxiety and Depression Scales ( HADS-A ) , also in carer and survivor versions .


Twenty-seven survivors and carers repeated the BOA after @ week .


Correlations between the carer BOA and the survivor HADS-A ( r = @ , p < @ ) and the survivor BOA ( r = @ , p < @ ) demonstrated construct validity .


Cronbach 's alpha for the carer BOA was @ ; item statistics did not identify any items for exclusion .


The test-retest coefficient at @ week was @ .


Receiver operating characteristic analysis against the survivor HADS-A and BOA produced areas under the curve of @ and @ , respectively .


At a cut-off score of @/@ sensitivity and specificity against the HADS-A were @ and @ , respectively , and @ and @ against the survivor BOA .


The impact of stroke on memory was associated with elevated anxiety .


Scores for both BOA versions were independent of demographic variables .


The carer BOA has acceptable psychometric properties and is independent of survivor demographic variables such as age .


It identifies self-reported cases with acceptable sensitivity and specificity .


It has potential for use with persons unable to self-report anxiety .


Further validation is recommended , but its continuing use is supported .


Ginseng root and its derivatives remain atop the most widely used medicinal herbs in cardiovascular disease , despite inadequate substantiation of efficacy .


We previously reported the potential of Korean red ginseng ( KRG ) to affect vascular tone by decreasing arterial wave reflection via an unknown mechanism .


Given the preclinical link between ginseng intake and vasoactivity related to nitric oxide ( NO ) production , we sought to directly evaluate the effects of KRG root and its major root components , on an established noninvasive measure of endothelial function .


In an acute , randomized , placebo-controlled , double-blind , crossover design , @ healthy participants ( @M :@ F , age :@ y , BMI : @ kg@kg/m ( @ ) , systolicBP/diastolicBP : @/@mmHg ) on four occasions were administered : KRG root ( @g ) , KRG ginsenosides extract , KRG polysaccharides extract , and cornstarch control .


Extracted fractions were delivered at doses bioequivalent to those found in @g of KRG .


Flow-mediated vasodilatation ( FMD ) assessment , preceding a brachial blood pressure measurement , was performed at baseline and at @ and @ min posttreatment to assess endothelial function .


KRG significantly improved FMD posttreatment .


Maximal vasodilatation of @ % occurred at @min compared with control ( -@ % , P = @ for all comparisons ) .


The ginsenoside extract produced a comparable response ( @ % ) , but not the polysaccharide fraction ( @ % ) .


Brachial blood pressure remained unchanged for all treatments ( P = @ ) .


KRG acutely improved endothelial function in healthy individuals , which appears to be attributable to its ginsenoside containing fraction .


Our data confirm preclinical data and support the potential for these compounds as targets for therapeutic strategies in disorders involving endothelial dysfunction .


The Micropuncture @-gauge needle may reduce complications related to vessel trauma from inadvertent venous or posterior arterial wall puncture .


This was a single-center , multiple-user trial .


Four hundred and two patients undergoing possible or definite percutaneous coronary intervention ( PCI ) were randomized @:@ to an @-gauge versus a @-gauge needle .


Patients and personnel pulling the sheaths and performing the follow-up were blinded .


The primary end point was a composite of access bleeding .


Events were tabulated following sheath removal , @ h after the procedure and at the follow-up ( at @-@ weeks ) .


End points were blindly adjudicated .


The event rate overall was @ % and did not differ significantly between groups , although the @-gauge needle was found to reduce events by more than one third .


An exploratory subgroup analysis of prespecified variables indicated that : patients who did not undergo PCI or elective procedures , female patients and those with a final sheath size of @ Fr all had a significant or near-significant reduction of complications with Micropuncture .


Although no significant differences between the use of the @ - and @-gauge needles were observed , there was a @-@ % reduction with Micropuncture in several subgroups .


The study was terminated prematurely .


Access site complications may be reduced by the use of the @-gauge needle , particularly when the risk of bleeding is not high .


Further multicenter data will be required to confirm these hypothesis-generating observations .


No randomized comparative trials have presented long-term outcomes for laparoscopic sleeve gastrectomy ( LSG ) and laparoscopic Roux-en-Y gastric bypass ( LRYGB ) .


The present study was designed to compare the efficacy and safety of these two procedures .


From January @ to July @ , @ eligible patients were randomly assigned to LSG or LRYGB .


During the @-year follow-up , we compared morbidity rate , body mass index ( BMI ) , percent of excess weight loss ( % EWL ) , Moorehead-Ardelt ( M-A ) II quality of life , and resolution or improvement rate of obesity-related comorbidities between the groups .


Both groups were matched with respect to age , gender , and BMI .


Slightly more major complications were observed in patients undergoing LRYGB ( P > @ ) .


Weight loss was significantly better with LRYGB except during the first postoperative year .


At @ years , % EWL for LSG and LRYGB was @ % and @ % ( P = @ ) , respectively .


No statistical difference was observed in quality of life between the groups at all intervals ( P > @ ) .


At the last follow-up , most comorbidities in both groups were resolved or improved , with no difference between the groups ( P > @ ) .


LRYGB and LSG are equally safe and effective in quality of life and improvement or resolution of comorbidities , and LRYGB possesses the superiority in terms of weight loss .


Further studies are needed to evaluate micronutrient deficiencies of these procedures .


To assess the effect of aerobic exercise on the cognition and functional capacity in Alzheimer 's disease ( AD ) patients .


Elderly ( n = @ ) with mild dementia ( NINCDS-ADRDA/CDR@ ) were randomly assigned to an exercise group ( EG ) on a treadmill ( @ minutes , twice a week and moderate intensity of @ % VOmax ) and control group ( GC ) @ patients .


The primary outcome measure was the cognitive function using Cambridge Cognitive Examination ( CAMCOG ) .


Specifics instruments were also applied to evaluate executive function , memory , attention and concentration , cognitive flexibility , inhibitory control and functional capacity .


After @ weeks , the EG showed improvement in cognition CAMCOG whereas the CG declined .


Compared to the CG , the EG presented significant improvement on the functional capacity .


The analysis of the effect size has shown a favorable response to the physical exercise in all dependent variables .


Walking on treadmill may be recommended as an augmentation treatment for patients with AD .


To evaluate the effects and clinical prognosis of out-patient department-based smoking cessation services for coronary heart disease ( CHD ) patients .


A total of @ smoking patients diagnosed with coronary heart disease in our cardiovascular department were randomly divided into the intensive smoking cessation clinic follow-up group ( intervention group , patients were informed on the importance and methods to quit smoking at the first visit and reminded for that at months interval for @ months , n = @ ) and the conventional treatment group ( control group , n = @ ) .


After @ months , the smoking status , cardiovascular event rates , drug usage , out-patient medical costs and quality of life were compared between the two groups .


Age , gender , concomitant diseases , drug usage were similar between the two groups at baseline ( all P > @ ) .


After @ months , smoking quit rate -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , P < @ -RSB- , drug use rates : lipid-lowering drugs -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) -RSB- , blockers -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) -RSB- , and ACEI/ARB -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) -RSB- were significantly higher in the intervention group than in the control group , while total cardiovascular event rates -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , P < @ -RSB- and out-patient medical costs ( @ RMB vs. @ RMB , P < @ ) were significantly lower in the intervention group than in the control group .


The quality of life scores derived from MYO health survey questionnaire was significantly higher in the intervention group than in the control group ( P < @ ) .


The top three reasons responsible for continuous smoking for all patients failed to quit smoking were : ( @ ) others smoked more than me and still alive and healthy -LSB- @ % ( @/@ ) -RSB- ; ( @ ) smoking helped me to keep relaxed and reduce trouble in daily work and life -LSB- @ % ( @/@ ) -RSB- ; ( @ ) smoking was essential while chatting and drinking with friends -LSB- @ % ( @/@ ) -RSB- .


The overall satisfactory rate to this smoking cessation program was @ % and the satisfactory rate was up to @ % by patients .


Intensive outpatient smoking cessation follow-up program can significantly improve the smoking cessation rates , the guideline drug use rate and the quality of life while reduce medical costs for coronary heart disease patients .


We conducted a prospective , randomized trial comparing protocol to ad libitum ( ad lib ) feeding after laparoscopic pyloromyotomy .


Infants undergoing laparoscopic pyloromyotomy were randomized to protocol versus ad lib feeding strategies .


The protocol started with Pedialyte two hours post-operative .


This was repeated by another round of Pedialyte , then two rounds of half-strength formula or breast milk , followed by two rounds of full strength formula or breast milk , followed by the home feeding regimen , at which time the patient was discharged if feeding well .


The ad lib group was allowed formula or breast milk two hours after the operation and considered for discharge after tolerating three consecutive feeds .


The primary outcome variable was the length of postoperative hospitalization .


One hundred fifty infants were enrolled between January @ and December @ .


There were no differences in patient characteristics at presentation .


While the ad lib group reached goal feeds sooner than the protocol group , this did not translate into a difference in duration of postoperative hospitalization .


There were more patients with emesis in the ad lib group after goal feeding was reached , but no difference in readmissions .


Ad lib feeding allows patients to reach goal feeds more rapidly than protocol feeding following laparoscopic pyloromyotomy .


However , this goal is usually reached beyond discharge hours , resulting in a similar duration of hospitalization .


To evaluate the efficacy of dienogest + estradiol valerate ( E@V ) and gonadotrophin-releasing hormone analogue ( GnRH-a ) in reducing recurrence of pain in patients with chronic pelvic pain due to laparoscopically diagnosed and treated endometriosis .


Multi-center , prospective , randomized study .


Three university departments of obstetrics and gynecology in Italy .


Seventy-eight women who underwent laparoscopic surgery for endometriosis combined with chronic pelvic pain .


Post-operative administration of dienogest + E@V for @ months ( group @ ) or GnRH-a monthly for @ months ( group @ ) .


A visual analogue scale was used to test intensity of pain before laparoscopic surgery at @ , @ and @ months of follow up .


A questionnaire to investigate quality of life was administered before surgery and at @ months of follow up .


The visual analogue scale score did not show any significant differences between the two groups ( p = @ ) .


The questionnaire showed an increase of scores for all women compared with pre-surgery values , demonstrating a marked improvement in quality of life and health-related satisfaction with both treatments .


No significant differences were found between the groups .


The rate of apparent endometriosis recurrence was @ % in group @ and @ % in group @ ( p = @ ) .


Both therapies seemed equally efficacious in preventing endometriosis-related chronic pelvic pain recurrence in the first @ months of follow-up .


The in utero environment is known to affect fetal development however many of the mechanisms by which this occurs remain unknown .


The aim of this study was to examine the association between maternal dietary macronutrient intake and lifestyle throughout pregnancy and neonatal weight and adiposity .


This was an analysis of @ mother and infant pairs from the ROLO study ( Randomised cOntrol trial of LOw glycaemic index diet versus no dietary intervention to prevent recurrence of fetal macrosomia ) .


Food diaries as well as food frequency and lifestyle and physical activity questionnaires were completed during pregnancy .


Maternal anthropometry was measured throughout pregnancy and neonatal anthropometry was measured at birth .


Multiple linear regression analysis revealed the main maternal factor associated with increased birth weight was greater gestational weight gain R@adj @ % ( F = @ , p < @ ) .


The main maternal factor associated with increased birth length was non-smoking status R@adj @ % ( F = @ , p < @ ) .


Neonatal central adiposity ( determined using waist : length ratio ) was negatively associated with maternal age , and positively associated with the following parameters : smoking status , maternal pre-pregnancy arm circumference , percentage energy from saturated fat in late pregnancy , postprandial glucose at @ weeks gestation and membership of the control group with a positive trend towards association with trimester @ glycaemic load R@adj @ % ( F = @ , p < @ ) .


Several maternal diet and lifestyle factors were associated with neonatal anthropometry .


Low glycaemic index dietary intervention in pregnancy was found to have a beneficial effect on neonatal central adiposity .


Additionally , central adiposity was positively associated with maternal dietary fat intake and postprandial glucose highlighting the important role of healthy diet in pregnancy in promoting normal neonatal adiposity .


To estimate the incremental cost-effectiveness of infliximab versus conventional combination treatment over @months in patients with methotrexate-refractory early rheumatoid arthritis .


In this multicentre , two-arm , parallel , randomised , active-controlled , open-label trial , rheumatoid arthritis patients with < @year symptom duration were recruited from @ rheumatology clinics in Sweden between October @ and December @ .


After @-@months of methotrexate monotherapy , patients not achieving low disease activity were randomised to addition of infliximab or sulfasalazine + hydroxychloroquine ( conventional treatment group ) .


Costs of drugs , healthcare use , and productivity losses were retrieved from nationwide registers , while EuroQol @-Dimensions utility was collected quarterly .


Of @ patients initially enrolled , @ and @ were randomised to infliximab and conventional treatment , respectively .


The infliximab group accumulated higher drug and healthcare costs ( @,@ vs @,@ ; adjusted mean difference @,@ ( @ % CI @,@ to @,@ ) ) , while productivity losses did not differ ( @,@ vs @,@ ; @ ( @ % CI -@ to @,@ ) ) , resulting in higher societal cost compared to the conventional group ( @,@ vs @,@ ; @,@ ( @ % CI @,@ to @,@ ) ) .


Mean accumulated quality-adjusted life-years ( QALYs ) did not differ ( @ vs @ ; adjusted mean difference favouring infliximab treatment @ ( @ % CI -@ to @ ) ) .


The incremental cost-effectiveness ratios for the infliximab versus conventional treatment strategy were @,@,@ / QALY from the societal perspective and @,@,@ / QALY from the healthcare perspective .


In early , methotrexate-refractory rheumatoid arthritis , a treatment strategy commencing with addition of infliximab , as compared to sulfasalazine + hydroxychloroquine , was not cost-effective over @months at willingness to pay levels generally considered acceptable .


To identify growth-related collagen and bone parameters in small-for-gestational-age ( SGA ) and appropriate-for-gestational-age ( AGA ) preterm infants during the first six months post-term .


In SGA preterm infants , increased growth and decreased bone acquisition , which we demonstrated previously , may be reflected by these markers .


Observational study within a randomized controlled trial .


Thirty-three SGA ( weight , length or both at birth < -@ SDS ) and @ AGA preterm infants ( gestational age -LSB- median ( IQR ) -RSB- : @ ( @ ) vs @ ( @ ) weeks ; @ % vs @ % boys ) .


Weight ( g ) , length ( cm ) , procollagen type I N-terminal peptide ( PINP ; g/l ) , urinary helical peptide ( UHP ; g/mmol creatinine ) and alkaline phosphatase ( ALP ; U/l ) expressed as standard deviation scores ( SDS ) at term age , three and six months post-term .


Weight and length gain during the first six months post-term and PINP SDS at term age , three months and six months post-term were higher in SGA compared with AGA infants .


UHP SDS and ALP SDS were similar in SGA and AGA infants .


PINP SDS and UHP SDS at term age and PINP SDS at three months were associated with subsequent weight and length gain until six months post-term .


Increased growth in SGA compared with AGA preterm infants is reflected by increased collagen type I synthesis during the first six months post-term , suggesting that PINP and UHP correspond with growth in preterm infants .


An explanation for decreased bone acquisition of SGA preterm infants may be that increased collagen type I synthesis is not directly followed by increased bone mineralization .


Current randomized trials have demonstrated the effects of short-term rosuvastatin therapy in preventing contrast-induced acute kidney injury ( CIAKI ) .


However , the consistency of these effects on patients administered different volumes of contrast media is unknown .


In the TRACK-D trial , @ patients with type @ diabetes and concomitant chronic kidney disease ( CKD ) who underwent coronary/peripheral arterial angiography with or without percutaneous intervention were randomized to short-term ( @ days before and @ days after procedure ) rosuvastatin therapy or standard-of-care .


This prespecified analysis compared the effects of rosuvastatin versus standard therapy in patients exposed to ( moderate contrast volume -LSB- MCV -RSB- , @-@ ml , n = @ ) or ( high contrast volume -LSB- HCV -RSB- , @ ml , n = @ ) .


The primary outcome was the incidence of CIAKI .


The secondary outcome was a composite of death , dialysis/hemofiltration or worsened heart failure at @ days .


Rosuvastatin treatment was associated with a significant reduction in CIAKI compared with the controls ( @ % vs. @ % , P = @ ) in the overall cohort and in patients with MCV ( @ % vs. @ % , P = @ ) , whereas no benefit was observed in patients with HCV ( @ % vs. @ % , P = @ ) .


The incidence of secondary outcomes was significantly lower in the rosuvastatin group compared with control group ( @ % vs. @ % , P = @ ) in the overall cohort , but it was similar between the patients with MCV ( @ % vs. @ % , P = @ ) or HCV ( @ % vs. @ % , P = @ ) .


Periprocedural short-term rosuvastatin treatment is effective in reducing CIAKI and adverse clinical events for patients with diabetes and CKD after their exposure to a moderate volume of contrast medium .


To investgate the effect of Xuebijing Injection on immune regulation in patients with systemic inflammatory response syndrome ( SIRS ) .


@ SIRS patients admitted to the ICU of Guizhou Provincial Hospital from January @ to December @ were included in this study .


The patients were randomly divided into a control ( C ) and a treatment ( T ) group .


Patients in C group received routine treatment ; while patients in T group received additional Xuebijing Injection @ mL Bid .


The following indicators were recorded and compared between the two groups before and @ and @ days after treatments : CD@ + , CD@ + , CD@ + / CD@ + , monocytes CD@ + / human leukocyte antigen-DR ( HLA-DR ) , score of acute physiology and chronic health evaluation II ( APACHE II ) , heart rate , white blood cells , body temperature , respiration rate , and MODS ( @ d after treatment only ) .


No differences were found between the two groups before treatments ( P > @ ) .


T Group had higher levels of CD@ + , CD@ , CD@ + / CD@ + and monocytes CD@ + / HLA-DR than C group at @ and @ d after treatments ( P < @ ) .


T group also had higher levels of improvement in vital indicators compared with C group ( P < @ ) .


No significant difference in incidence of multiple organ dysfunction syndrome ( MODS ) was found between the two groups ( P > @ ) .


Xuebijing Injection can regulate immune function of patients with SIRS .


Incisional hernias in old stoma wounds occur in one-third of former stoma patients and pose a significant clinical problem .


Parastomal hernias can be prevented by prophylactic mesh placement ; however , no trial results are available for incisional hernia prevention after stoma reversal .


In this feasibility study , we explore the safety of placing an intraperitoneal mesh to prevent incisional herniation after temporary stoma reversal .


Ten patients who underwent a low anterior resection with a deviating double-loop stoma for rectal cancer received an intraperitoneal parastomal mesh at the time of stoma formation .


At stoma reversal , laparoscopy was performed and adhesions were scored .


After reversal , the mesh defect was closed .


Mesh and stoma complications were closely monitored .


Incisional herniation was assessed at the @-year follow-up after stoma reversal using ultrasonography .


No infections occurred after mesh placement .


After a median of @ months , stomas were reversed .


Laparoscopy could be performed in seven patients ; all patients had adhesions ( median of @ % of mesh surface ) .


In three patients , the bowel was involved ; one required a laparotomy for bowel mobilization during stoma reversal .


No adhesion-related morbidity was noted at any time .


Except for one superficial wound infection after stoma reversal , no infectious complications were observed .


After a median follow-up of @ months , no incisional herniations were demonstrated .


Prophylactic mesh placement in temporary stoma formations seems safe and feasible and prevents incisional herniation @ years after stoma reversal .


We aimed to compare panitumumab , a fully human monoclonal antibody against EGFR , plus radiotherapy with chemoradiotherapy in patients with unresected , locally advanced squamous-cell carcinoma of the head and neck .


In this international , open-label , randomised , controlled , phase @ trial , we recruited patients with locally advanced squamous-cell carcinoma of the head and neck from @ sites in eight countries worldwide .


Patients aged @ years and older with stage III , IVa , or IVb , previously untreated , measurable ( @ mm for at least one dimension ) , locally advanced squamous-cell carcinoma of the head and neck ( non-nasopharygeal ) and an Eastern Cooperative Oncology Group performance status of @-@ were randomly assigned ( @:@ ) by an independent vendor to open-label chemoradiotherapy ( two cycles of cisplatin @ mg/m ( @ ) during radiotherapy ) or to radiotherapy plus panitumumab ( three cycles of panitumumab @ mg/kg every @ weeks administered with radiotherapy ) using a stratified randomisation with a block size of five .


All patients received @-@ Gy to gross tumour and @ Gy to areas of subclinical disease with accelerated fractionation radiotherapy .


The primary endpoint was local-regional control at @ years , analysed in all randomly assigned patients who received at least one dose of their assigned protocol-specific treatment ( chemotherapy , radiation , or panitumumab ) .


The trial is closed and this is the final analysis .


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


Between Nov @ , @ , and Nov @ , @ , @ patients were enrolled , and @ received treatment ( @ in the chemoradiotherapy group and @ in the radiotherapy plus panitumumab group ) .


Local-regional control at @ years was @ % ( @ % CI @-@ ) in the chemoradiotherapy group and @ % ( @-@ ) in the radiotherapy plus panitumumab group .


The most frequent grade @-@ adverse events were mucosal inflammation ( @ -LSB- @ % -RSB- of @ patients in the chemoradiotherapy group vs @ -LSB- @ % -RSB- of @ patients in the radiotherapy plus panitumumab group ) , dysphagia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and radiation skin injury ( seven -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Serious adverse events were reported in @ ( @ % ) of @ patients in the chemoradiotherapy group and in @ ( @ % ) of @ patients in the radiotherapy plus panitumumab group .


Panitumumab can not replace cisplatin in the combined treatment with radiotherapy for unresected stage III-IVb squamous-cell carcinoma of the head and neck , and the role of EGFR inhibition in locally advanced squamous-cell carcinoma of the head and neck needs to be reassessed .


High-intensity focused ultrasound ( HIFU ) is a noninvasive alternative to traditional invasive body sculpting procedures .


To assess the effectiveness and tolerability of HIFU treatment using high and low fluence settings with @ treatment techniques , grid repeat ( GR ) and site repeat ( SR ) .


Two multicenter studies were conducted .


Subjects underwent @ HIFU treatment with @ of @ treatment protocols ( total fluence , @-@ J/cm ) .


Primary end point was change from baseline in waist circumference ( CBWC ) at @ weeks .


Secondary end points included CBWC at @ and @ weeks and investigator - and subject-assessed clinical improvement .


Adverse events were monitored throughout the study .


In the intent-to-treat ( ITT ) population , all subjects had a statistically significant mean circumferential reduction of -@ @ cm ( p < @ ) from baseline at @ weeks , with no significant differences among the @ treatment groups ( ITT : p = @ ) .


Analysis of secondary end points in the ITT population demonstrated a significant circumferential reduction starting as early as @ weeks in all subjects ( -@ @ cm , p < @ ) .


Most subjects in all treatment groups showed improvements at @ weeks as rated by the investigators and subjects .


High-intensity focused ultrasound treatment using either a low or high fluence setting in a GR or SR method is effective for circumferential waist reduction , resulting in statistically significant CBWC in all treatment groups .


Postoperative readmissions have been proposed by Medicare as a quality metric and can impact provider reimbursement .


Because readmission after pancreatectomy is common , we sought to identify factors associated with readmission to establish a predictive risk scoring system .


A retrospective analysis of @,@ pancreatectomies performed at @ high-volume pancreatic centers between @ and @ was performed .


Forty-five factors strongly associated with readmission were identified .


To derive and validate a risk scoring system , the population was randomly divided into @ cohorts in a @:@ fashion .


A multivariable logistic regression model was constructed and scores were assigned based on the relative odds ratio ( OR ) of each independent predictor .


A composite Readmission after Pancreatectomy ( RAP ) score was generated and then stratified to create risk groups .


Overall , @ ( @ % ) patients were readmitted within @ days .


Eight pre - and postoperative factors , including earlier MI ( OR = @ ) , American Society of Anesthesiologists class @ ( OR = @ ) , dementia ( OR = @ ) , hemorrhage ( OR = @ ) , delayed gastric emptying ( OR = @ ) , surgical site infection ( OR = @ ) , sepsis ( OR = @ ) , and short length of stay ( OR = @ ) were independently predictive of readmission .


The @-point RAP score generated from the derivation cohort was highly predictive of readmission in the validation cohort ( area under the receiver operating curve = @ ) .


The low-risk ( @ to @ ) , intermediate-risk ( @ to @ ) , and high-risk ( > @ ) groups correlated with @ % , @ % , and @ % observed readmission rates , respectively ( p < @ ) .


The RAP score is a novel and clinically useful risk scoring system for readmission after pancreatectomy .


Identification of patients with increased risk of readmission using the RAP score will allow efficient resource allocation aimed to attenuate readmission rates .


It also has potential to serve as a new metric for comparative research and quality assessment .


To compare the induction of remission and cost-effectiveness of enteral nutrition ( EN ) and infliximab ( IFX ) in moderate-to-severe active Crohn 's disease ( CD ) .


Moderate-to-severe active CD patients were divided into IFX group and EN group .


Remission rate , time to remission and treatment cost were compared between the two groups .


Clinical remission was defined as Crohn 's disease activity index ( CDAI ) < @ .


The quality of life was evaluated by inflammatory bowel disease questionnaire of quality of life ( IBDQ ) .


A total of @ patients were analyzed , including @ patients in IFX group and @ patients in EN group .


IFX group had higher remission rate -LSB- @ % ( @/@ ) vs @ % ( @/@ ) , P = @ -RSB- and shorter time to remission -LSB- ( @ @ ) days vs ( @ @ ) days , P < @ -RSB- than EN group .


Treatment costs before remission were similar in two groups ( P = @ ) .


The increase of IBDQ scores before and after treatment in IFX group was much higher than that of EN group ( @ @ vs @ @ , P < @ ) .


Similarly , patients in EN group had greater increase of body mass index ( BMI ) than that of IFX group -LSB- ( @ @ ) kg/m ( @ ) vs ( @ @ ) kg/m ( @ ) , P < @ -RSB- .


For patients with CDAI < @ , remission rate was not significantly different -LSB- @ % ( @/@ ) vs @ % ( @/@ ) , P = @ -RSB- between the two groups , while treatment cost in EN group was less than that of IFX group -LSB- ( @ @ ) @ ( @ ) RMB vs ( @ @ ) @ ( @ ) RMB , P = @ -RSB- .


For patients with severe CD ( CDAI @ ) , IFX has higher remission rate , shorter time to remission and comparable treatment cost than EN .


But for patients with CDAI < @ , EN group has comparable remission rate to IFX group with lower cost .


Testicular germ cell cancer ( GCC ) patients treated with cisplatin-etoposide-bleomycin chemotherapy ( BEP ) have excellent prognosis but have an increased risk of late-occurring morbidities , which may be associated with changes in the inflammatory profile .


The objective of the study was to explore plasma cytokine concentrations in GCC patients randomized to resistance training or usual care during BEP , in comparison with healthy controls .


This was a randomized controlled trial in GCC patients enrolled from an oncology clinic , including a healthy reference group for comparison purposes .


Plasma granulocyte macrophage colony-stimulating factor , interferon - , IL-@ , IL-@ , IL-@ , IL-@ , IL-@ , IL-@ , and TNF - were measured in fasting blood samples from GCC patients randomized to resistance training ( INT ; n = @ ) or usual care ( CON ; n = @ ) and healthy age-matched controls ( REF ; n = @ ) .


Clinical toxicity assessments and patient-reported end points were also recorded .


CON and INT were balanced at baseline .


Compared with REF , CON had higher concentrations of IL-@ , IL-@ , and interferon - , and INT had higher concentrations of IL-@ , IL-@ and TNF - ( all P < @ ) .


At the end of therapy , concentrations of IL-@ , IL-@ , and IL-@ increased in both GCC groups ( all P < @ ) .


Three months after therapy , all cytokine concentrations were comparable with the pretreatment levels in both GCC-groups but remained elevated compared with REF ( P < @ ) .


Changes in TNF - correlated with pulmonary toxicity ( P < @ ) .


At the end of therapy , IL-@ concentrations correlated with quality of life ( P < @ ) and fatigue ( P < @ ) .


GCC patients treated with BEP display consistently elevated levels of systemic inflammatory markers compared with healthy controls .


Resistance training during therapy has no impact on plasma cytokine concentrations .


This work tested the hypothesis that patients with high negative affectivity ( NA ) would have a better response to a serotonergic agent ( escitalopram ) than to one not thought to act directly on serotonin ( bupropion ) .


Data from a study conducted between August @ and July @ were reanalyzed retrospectively .


Patients ( N = @ ) meeting criteria for major depressive disorder ( MDD ) , diagnosed with DSM-IV-TR , were randomly assigned to double-blind treatment with bupropion extended-release , escitalopram , or the combination .


Negative affectivity score was estimated using the guilt , hostility/irritability , and fear/anxiety items of the Hamilton Depression Rating Scale , the Montgomery-Asberg Depression Rating Scale , the Quick Inventory of Depressive Symptoms , and the Social Adjustment Scale .


We felt that these items captured published descriptions of the NA construct .


A Clinical Global Impressions-Severity of Illness ( CGI-S ) score @ defined response .


Because combined treatment addressed both serotonin and non-serotonin systems , patients treated with both medications did not test the hypothesis and so were excluded from the analyses .


Analysis of covariance with treatment as a grouping variable , NA as covariate , and CGI-S as dependent variable showed a significant @-way interaction between treatment and NA ( F , = @ , P < @ ) .


In the low-NA group , response rates were similar between treatments ( escitalopram : @/@ -LSB- @ % -RSB- ; bupropion : @/@ -LSB- @ % -RSB- ; NS ) , while there was a significant advantage for escitalopram in patients with high NA ( escitalopram : @/@ -LSB- @ % -RSB- ; bupropion = @/@ -LSB- @ % -RSB- ; P = @ ) .


These data suggest that patients with high negative affectivity respond preferentially to antidepressants that selectively enhance serotonin neurotransmission .


Although patients with low NA appear to benefit from serotonin enhancement as well , they also improved with bupropion , an antidepressant not thought to directly affect serotonin neurotransmission .


These findings come from retrospective analyses using unproven approximation of NA , so no clinical inferences should be made before independent replication utilizing accepted NA measurement .


There is no consensus on the efficacy of postoperative infusion of local anesthetics after radical mastectomy .


A randomized , double-blind , placebo-controlled , parallel-groups clinical trial was conducted in a tertiary hospital .


Eighty consecutive women with operable breast cancer with indications for modified radical mastectomy without breast reconstruction were assigned randomly to receive infusion of levobupivacaine ( @ % ) or saline at @ ml/hour for @ hours through a wound catheter .


Seventy-three women finished the study ( intervention group , n = @ ; control group , n = @ ) .


During surgery , all patients received @ % levobupivacaine ( @ ml ) .


The levobupivacaine group reported less pain ( p < @ ) than controls in the postanesthesia care unit ( @ @ versus @ @ ) and on the ward at @ ( @ @ versus @ @ ) and @ ( @ @ versus @ @ ) hours .


In the postanesthesia care unit , the levobupivacaine group consumed less metamizole ( @ @ versus @ @ ; p < @ ) and dexketoprofen ( @ @ versus @ @ ; p < @ ) , with differences in paracetamol use being insignificant ( @ @ versus @ @ ; p = @ ) .


On the ward , the levobupivacaine group used significantly less paracetamol ( @ @ versus @ @ ; p < @ ) and metamizole ( @ @ versus @ @ ; p < @ ) , but differences in dexketoprofen were not significant ( @ @ versus @ @ ; p = @ ) .


In the postanesthesia care unit , the levobupivacaine and control groups consumed @ @ and @ @ doses of opioids ( p = @ ) , respectively .


The authors observed no differences in nausea and vomiting at any stage in the postanesthesia care unit ( @ @ versus @ @ ; p = @ ) or on the ward ( @ @ versus @ @ ; p = @ ) .


All participants reported high levels of satisfaction .


Continuous infusion of local anesthetic reduces pain and analgesic consumption , with high satisfaction , but does not affect rates of nausea and vomiting .


The Interventional Management of Stroke ( IMS ) III study tested the effect of intravenous tissue-type plasminogen activator ( tPA ) alone when compared with intravenous tPA followed by endovascular therapy and collected cost data to assess the economic implications of the @ therapies .


This report describes the factors affecting the costs of the initial hospitalization for acute stroke subjects from the United States .


Prospective cost analysis of the US subjects was treated with intravenous tPA alone or with intravenous tPA followed by endovascular therapy in the IMS III trial .


Results were compared with expected Medicare payments .


The adjusted cost of a stroke admission in the study was $ @ @ for subjects treated with endovascular therapy after intravenous tPA treatment and $ @ @ for subjects treated with intravenous tPA alone ( P < @ ) .


Significant factors related to costs included treatment group , baseline National Institutes of Health Stroke Scale , time from stroke onset to intravenous tPA , age , stroke location , and comorbid diabetes mellitus .


The mean cost for subjects who had routine use of general anesthesia as part of endovascular therapy was $ @ @ when compared with $ @ @ for those who did not have general anesthesia .


The costs of embolectomy for IMS III subjects and patients from the National Inpatient Sample cohort exceeded the Medicare diagnosis-related group payment in @ % of patients .


Minimizing the time to start of intravenous tPA and decreasing the use of routine general anesthesia may improve the cost-effectiveness of medical and endovascular therapy for acute stroke .


Dietary linoleic acid ( LA , @:@ n-@ ) lowering in rats reduces n-@ polyunsaturated fatty acid ( PUFA ) plasma concentrations and increases n-@ PUFA ( eicosapentaenoic ( EPA ) and docosahexaenoic acid ( DHA ) ) concentrations .


To evaluate the extent to which @ weeks of dietary n-@ PUFA lowering , with or without increased dietary n-@ PUFAs , alters unesterified and esterified plasma n-@ and n-@ PUFA concentrations in subjects with chronic headache .


Secondary analysis of a randomized trial .


Subjects with chronic headache were randomized for @ weeks to ( @ ) average n-@ , low n-@ ( L@ ) diet ; or ( @ ) high n-@ , low n-@ LA ( H@-L@ ) diet .


Esterified and unesterified plasma fatty acids were quantified at baseline ( @ weeks ) and after @ weeks on a diet .


Compared to baseline , the L@ diet reduced esterified plasma LA and increased esterified n-@ PUFA concentrations ( nmol/ml ) , but did not significantly change plasma arachidonic acid ( AA , @:@ n-@ ) concentration .


In addition , unesterified EPA concentration was increased significantly among unesterified fatty acids .


The H@-L@ diet decreased esterified LA and AA concentrations , and produced more marked increases in esterified and unesterified n-@ PUFA concentrations .


Dietary n-@ PUFA lowering for @ weeks significantly reduces LA and increases n-@ PUFA concentrations in plasma , without altering plasma AA concentration .


A concurrent increase in dietary n-@ PUFAs for @ weeks further increases n-@ PUFA plasma concentrations and reduces AA .


Cognitive behaviour therapy ( CBT ) has been found to reduce the impact of menopausal symptoms , hot flushes and night sweats .


This study investigates the moderators and mediators of CBT for women who had problematic menopausal symptoms following breast cancer treatment .


Analysis of @ patients with breast cancer induced menopausal symptoms recruited to the MENOS@ trial ; @ were randomly assigned to Group CBT and @ to usual care .


Questionnaires were completed at baseline , @ and @ weeks post randomisation .


Potential moderators and mediators , including sociodemographic , clinical and psychological factors , of the treatment effect on the primary outcome were examined .


Hot Flush Problem Rating .


CBT was effective at reducing problem rating at @ weeks regardless of age , BMI , time since breast cancer diagnosis , menopausal status at time of diagnosis , or type of cancer treatment ( radiotherapy or chemotherapy or endocrine treatment ) .


The treatment effect was significantly greater in women not receiving chemotherapy , those with higher levels of psychological distress at baseline and for non-white women .


Beliefs about control/coping with hot flushes were the main mediators of improvement in problem rating following CBT .


Beliefs about hot flushes in a social context , depressed mood and sleep problems were also identified as mediators .


These findings suggest that CBT is widely applicable for breast cancer patients who are experiencing treatment related menopausal symptoms , and that CBT works mainly by changing beliefs and improving mood and sleep .


Opioid-induced androgen deficiency ( OPIAD ) affects patients treated with opioid analgesics .


The norepinephrine reuptake inhibitor ( NRI ) and - opioid receptor ( MOR ) agonist activities of tapentadol may result in tapentadol having less effect on serum androgen concentrations than analgesics acting through the MOR alone , such as morphine and oxycodone .


The objectives of this publication are to @ ) evaluate the effects of tapentadol ( NUCYNTA and NUCYNTA extended release -LSB- ER -RSB- ) on sex hormone concentrations in healthy male volunteers ( vs placebo and morphine ) and patients with osteoarthritis ( vs placebo and oxycodone ) , and @ ) present a mechanistic hypothesis explaining how the combined MOR agonist and NRI activities of tapentadol may result in less impact on androgen concentrations .


Three clinical studies were conducted : study @ ( single-dose comparison study vs morphine in healthy volunteers ) , study @ ( single-dose-escalation study in healthy volunteers without an active comparator ) , and study @ ( multiple-dose study vs oxycodone in patients with osteoarthritis ) .


Studies @ and @ were conducted at medical research centers in Germany and the United Kingdom ; study @ was conducted at primary and secondary care centers and medical research centers in the United States .


All three studies were randomized , double blind , and placebo controlled .


Concentrations of testosterone , luteinizing hormone ( LH ) , and follicle-stimulating hormone ( FSH ; study @ only ) were evaluated at @ and @ hours postdose in studies @ and @ , respectively , and at varying time points postdose in study @ .


In study @ , mean serum total testosterone concentrations in healthy male volunteers were similar at baseline for all treatment periods ; @ hours after dosing , mean concentrations were comparable between placebo ( @ nmol/L ) and tapentadol immediate release ( IR ; @ mg , @ nmol/L ; @ mg , @ nmol/L ) , but were lower following administration of morphine IR @ mg ( @ nmol/L ) .


In study @ , there were no or minimal changes in testosterone in the therapeutic dose range with tapentadol IR ( @-@ mg ) , and there was a modest decrease that appeared to level off in the supratherapeutic range ( @-@ mg ) ; mean testosterone and LH concentrations with all doses remained within normal ranges ( testosterone , @-@ @ nmol/L ; LH , @-@ @ U/L ) .


In study @ , the decrease in the mean -LSB- standard deviation -RSB- testosterone concentration from baseline to endpoint for male patients receiving tapentadol ER ( @ mg , -@ -LSB- @ -RSB- nmol/L ; @ mg , -@ -LSB- @ -RSB- nmol/L ) was numerically smaller compared to oxycodone CR ( @ mg , -@ -LSB- @ -RSB- nmol/L ) , but higher compared to placebo ( -@ -LSB- @ -RSB- nmol/L ) .


These results suggest that tapentadol , which has combined MOR and NRI activities , may have a lower impact on sex hormone concentrations than pure opioid analgesics , such as morphine or oxycodone .


The data and mechanistic rationale presented herein provide a justification for conducting additional hypothesis testing studies , and are not intended to be used as a basis for clinical decision making .


Future studies may help elucidate whether the observed trends are clinically significant and would translate into a reduced incidence of OPIAD .


Evaluate the @-week efficacy and safety of desvenlafaxine at the recommended dose of @ mg/d in perimenopausal and postmenopausal women with major depressive disorder ( MDD ) based on the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , Text Revision .


This phase @ , multicenter , parallel-group , randomized , double-blind , placebo-controlled study was conducted from June @ , @ , to June @ , @ .


Patients received placebo or desvenlafaxine @ mg/d ( @:@ ratio ; n = @ in each group ) .


The primary outcome measure was the change at week @ in the @-item Hamilton Depression Rating Scale ( HDRS@ ) total score .


Secondary outcome measures included change in the Sheehan Disability Scale ( SDS ) , the Clinical Global Impressions-Improvement scale ( CGI-I ) , the Montgomery-Asberg Depression Rating Scale ( MADRS ) , and the Visual Analog Scale-Pain Intensity ( VAS-PI ) .


At end point , compared to placebo , desvenlafaxine was associated with a significantly greater decrease in HDRS@ total scores ( last-observation-carried-forward analysis ; adjusted mean change from baseline -@ vs -@ , respectively ; P = @ ) and significant improvements on the CGI-I ( P < @ ) , MADRS ( P = @ ) , SDS ( P = @ ) , and VAS-PI ( P < @ ) .


Improvements on the SDS and VAS-PI reached significance by week @ .


Desvenlafaxine was generally safe and well tolerated .


Short-term treatment with desvenlafaxine @ mg/d was effective for the treatment of MDD in perimenopausal and postmenopausal women , with significant benefits on pain and functional outcomes evident as early as week @ .


The safety and tolerability of desvenlafaxine were consistent with data in other populations .


Anemia is associated with poor tumor control .


It was previously observed that accelerated radiotherapy combined with carbogen breathing and nicotinamide ( ARCON ) can correct this adverse outcome in patients with head and neck cancer .


The purpose of this study was to validate this observation based on data from a randomized trial .


Of @ patients with cT@-@ laryngeal cancer , @ were randomly assigned to accelerated radiotherapy and @ to ARCON .


Hemoglobin levels , measured before treatment , were defined as low when < @ mmol/L for women and < @ mmol/L for men .


The hypoxia marker pimonidazole was used to assess the oxygenation status in tumor biopsies .


Data were analyzed @ years after inclusion of the last patient .


Pretreatment hemoglobin levels were available and below normal in @ of @ ( @ % ) accelerated radiotherapy and @ of @ ( @ % ) ARCON patients .


In patients with normal pretreatment , hemoglobin levels treatment with ARCON had no significant effect on @-year loco-regional control ( LRC , @ % versus @ % ; P = @ ) and disease-free survival ( DFS , @ % vs. @ % ; P = @ ) compared with accelerated radiotherapy .


However , in patients with low pretreatment , hemoglobin levels ARCON significantly improved @-year LRC ( @ % vs. @ % ; P = @ ) and DFS ( @ % vs. @ % ; P = @ ) .


In multivariate analysis including other prognostic factors , pretreatment hemoglobin remained prognostic for LRC and DFS in the accelerated radiotherapy treatment arm .


No correlation between pretreatment hemoglobin levels and pimonidazole uptake was observed .


Results from the randomized phase III trial support previous observations that ARCON has the potential to correct the poor outcome of cancer patients with anemia ( ClinicalTrials.gov number , NCT@ ) .