The sensitivity of the obligatory glycineB co-agonist binding site may change with daily administration of DCS as a result of agonist-induced desensitization .


The efficacy of a `` pulsed '' once-weekly administration versus `` daily '' administration of DCS was compared .


Males and females , ages @ to @ years , with a Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition Text Revision diagnosis of an ASD were enrolled in a double-blind , randomized @-week trial consisting of @ weeks of active drug with either weekly or daily administration of @ mg of DCS followed by a @-week follow-up visit .


For the purposes of this study , no statistical or clinical differences existed between the @ dosage groups on the Aberrant Behavior Checklist subscale @ , which measures stereotypies/repetitive movements .


When combining groups , a statistically significant decrease of @ % was found from baseline to week @ when study drug was completed using a linear mixed effects model ( P = @ ) .


D-Cycloserine was shown to be effective in improving stereotypic symptoms in older adolescents and young adults with ASDs measured by the Aberrant Behavior Checklist subscale @ .


In addition , DCS was safe and well tolerated .


We estimate the effect size of hypoglycemia risk reduction on closed-loop control ( CLC ) versus open-loop ( OL ) sensor-augmented insulin pump therapy in supervised outpatient setting .


Twenty patients with type @ diabetes initiated the study at the Universities of Virginia , Padova , and Montpellier and Sansum Diabetes Research Institute ; @ completed the entire protocol .


Each patient participated in two @-h outpatient sessions , CLC versus OL , in randomized order .


Sensor ( Dexcom G@ ) and insulin pump ( Tandem t : slim ) were connected to Diabetes Assistant ( DiAs ) - a smartphone artificial pancreas platform .


The patient operated the system through the DiAs user interface during both CLC and OL ; study personnel supervised on site and monitored DiAs remotely .


There were no dietary restrictions ; @-min walks in town and restaurant dinners were included in both CLC and OL ; alcohol was permitted .


The primary outcome-reduction in risk for hypoglycemia as measured by the low blood glucose ( BG ) index ( LGBI ) - resulted in an effect size of @ , P = @ , with a twofold reduction of hypoglycemia requiring carbohydrate treatment : @ vs. @ episodes/session on CLC versus OL ( P = @ ) .


This was accompanied by a slight decrease in percentage of time in the target range of @-@ mmol/L ( @ vs. @ % ) and increase in mean BG ( @ vs. @ mmol/L ; P = @ ) on CLC versus OL .


CLC running on a smartphone ( DiAs ) in outpatient conditions reduced hypoglycemia and hypoglycemia treatments when compared with sensor-augmented pump therapy .


This was accompanied by marginal increase in average glycemia resulting from a possible overemphasis on hypoglycemia safety .


Both corticosteroid and pentoxifylline reduce short-term mortality in severe alcoholic hepatitis .


However , few studies have directly compared the efficacy of pentoxifylline and corticosteroid in patients with this condition .


In this multicentre , open-labelled , randomised non-inferiority trial , we assigned @ patients with severe alcoholic hepatitis ( Maddrey 's discriminant function @ ) to receive either pentoxifylline ( @ mg , @ times daily , in @ subjects ) or prednisolone ( @ mg daily , in @ subjects ) .


The primary end point was non-inferiority in survival at the @ month time point for the pentoxifylline treatment compared with prednisolone .


The @-month survival rate of patients receiving pentoxifylline was @ % ( @ deaths ) compared with @ % ( @ deaths ) in those , taking prednisolone , for a treatment difference of @ % ( @ % confidence interval , -@ % to @ % ; p = @ ) .


The @ % confidence interval for the observed difference exceeded the predefined margin of non-inferiority ( @ % ) and included zero .


The @-month survival rate was not significantly different between the pentoxifylline and prednisolone groups ( @ % vs. @ % ; p = @ ) .


At @ days , the response to therapy assessed by the Lille model was significantly lower in the prednisolone group ( n = @ ) than in the pentoxifylline group ( n = @ @ ) : @ vs. @ ( p = @ ) .


Hepatitis complications , including hepatorenal syndrome and side effects , such as infection and gastrointestinal bleeding , were similar in the two groups .


The findings demonstrate that the efficacy of the pentoxifylline is not statistically equivalent to the efficacy of prednisolone , supporting the use of prednisolone as a preferred treatment option in patients with severe alcoholic hepatitis .


The potential for transmission of infectious diseases offered by the school environment are likely to be an important contributor to the rates of infectious disease experienced by children .


This study aimed to test whether the addition of hand sanitiser in primary school classrooms compared with usual hand hygiene would reduce illness absences in primary school children in New Zealand .


This parallel-group cluster randomised trial took place in @ primary schools , where schools were allocated using restricted randomisation ( @:@ ratio ) to the intervention or control group .


All children ( aged @ to @ y ) in attendance at participating schools received an in-class hand hygiene education session .


Schools in the intervention group were provided with alcohol-based hand sanitiser dispensers in classrooms for the winter school terms ( @ April to @ September @ ) .


Control schools received only the hand hygiene education session .


The primary outcome was the number of absence episodes due to any illness among @,@ follow-up children whose caregivers were telephoned after each absence from school .


Secondary outcomes measured among follow-up children were the number of absence episodes due to specific illness ( respiratory or gastrointestinal ) , length of illness and illness absence episodes , and number of episodes where at least one other member of the household became ill subsequently ( child or adult ) .


We also examined whether provision of sanitiser was associated with experience of a skin reaction .


The number of absences for any reason and the length of the absence episode were measured in all primary school children enrolled at the schools .


Children , school administrative staff , and the school liaison research assistants were not blind to group allocation .


Outcome assessors of follow-up children were blind to group allocation .


Of the @,@ and @,@ follow-up children in the hand sanitiser and control groups , respectively , the rate of absence episodes due to illness per @ child-days was similar ( @ and @ , respectively , incidence rate ratio @ , @ % CI @ to @ ) .


The provision of an alcohol-based hand sanitiser dispenser in classrooms was not effective in reducing rates of absence episodes due to respiratory or gastrointestinal illness , the length of illness or illness absence episodes , or the rate of subsequent infection for other members of the household in these children .


The percentage of children experiencing a skin reaction was similar ( @ % hand sanitiser versus @ % control , risk ratio @ , @ % CI @ to @ ) .


The rate or length of absence episodes for any reason measured for all children also did not differ between groups .


Limitations of the study include that the study was conducted during an influenza pandemic , with associated public health messaging about hand hygiene , which may have increased hand hygiene among all children and thereby reduced any additional effectiveness of sanitiser provision .


We did not quite achieve the planned sample size of @,@ follow-up children per group , although we still obtained precise estimates of the intervention effects .


Also , it is possible that follow-up children were healthier than non-participating eligible children , with therefore less to gain from improved hand hygiene .


However , lack of effectiveness of hand sanitiser provision on the rate of absences among all children suggests that this may not be the explanation .


The provision of hand sanitiser in addition to usual hand hygiene in primary schools in New Zealand did not prevent disease of severity sufficient to cause school absence .


To compare epidural analgesia ( EDA ) to patient-controlled opioid-based analgesia ( PCA ) in patients undergoing laparoscopic colorectal surgery .


EDA is mainstay of multimodal pain management within enhanced recovery pathways -LSB- enhanced recovery after surgery ( ERAS ) -RSB- .


For laparoscopic colorectal resections , the benefit of epidurals remains debated .


Some consider EDA as useful , whereas others perceive epidurals as unnecessary or even deleterious .


A total of @ patients undergoing elective laparoscopic colorectal resections were enrolled in a randomized clinical trial comparing EDA versus PCA .


Primary end point was medical recovery .


Overall complications , hospital stay , perioperative vasopressor requirements , and postoperative pain scores were secondary outcome measures .


Analysis was performed according to the intention-to-treat principle .


Final analysis included @ EDA patients and @ PCA patients .


Both groups were similar regarding baseline characteristics .


Medical recovery required a median of @ days ( interquartile range -LSB- IQR -RSB- , @-@ @ days ) in EDA patients and @ days ( IQR , @-@ days ) in the PCA group ( P = @ ) .


PCA patients had significantly less overall complications -LSB- @ ( @ % ) vs @ ( @ % ) ; P = @ -RSB- but a similar hospital stay -LSB- @ days ( IQR , @-@ days ) vs @ days ( IQR , @-@ days ) ; P = @ -RSB- .


Significantly more EDA patients needed vasopressor treatment perioperatively ( @ % vs @ % , P = @ ) , the day of surgery ( @ % vs @ % , P < @ ) , and on postoperative day @ ( @ % vs @ % , P < @ ) , whereas no difference in postoperative pain scores was noted .


Epidurals seem to slow down recovery after laparoscopic colorectal resections without adding obvious benefits .


EDA can therefore not be recommended as part of ERAS pathways in laparoscopic colorectal surgery .


To evaluate whether baseline acute and chronic prostate inflammation among men with initial negative biopsy for prostate cancer ( PC ) is associated with PC volume at the @-year repeat prostate biopsy in a clinical trial with systematic biopsies .


Retrospective analysis of @ men with negative baseline prostate biopsy and positive @-year repeat biopsy in the Reduction by Dutasteride of PC Events ( REDUCE ) study .


Acute and chronic inflammation and tumor volume were determined by central pathology .


The association of baseline inflammation with @-year repeat biopsy cancer volume was evaluated with linear and Poisson regressions controlling for demographics and laboratory variables .


Chronic , acute inflammation , and both were detected in @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) baseline biopsies , respectively .


Acute and chronic inflammation were significantly associated with each other ( P < @ ) .


Chronic inflammation was associated with larger prostate ( P < @ ) and lower pre-repeat biopsy PSA ( P = @ ) .


At @-year biopsy , baseline chronic inflammation was associated with lower mean tumor volume ( @ l vs. @ l ; P = @ ) , number of biopsy cores involved ( @ vs. @ ; P < @ ) , percent of cores involved ( @ % vs. @ % ; P < @ ) , core involvement ( @ l vs. @ l ; P < @ ) , and overall percent tumor involvement ( @ % vs. @ % ; P < @ ) .


Results were unchanged in multivariable analysis .


Baseline acute inflammation was not associated with any tumor volume measurement .


In a cohort of men with @-year repeat prostate biopsy positive for PC after a negative baseline biopsy , baseline chronic inflammation was associated with lower PC volume .


To assess healthcare processes during treatment of neovascular age-related macular degeneration ( AMD ) in patients under real-life conditions and evaluate efficacy of monthly visual acuity ( VA ) assessment in a pro re nata treatment regime .


A multicentre , prospective , non-interventional study based in Germany included neovascular AMD patients treated with intravitreal ranibizumab .


Patients completed a @-month loading phase with monthly intravitreal injections of @ mg ranibizumab , followed by a @-month maintenance phase during which investigators documented VA , additional injections , metamorphopsias , routine ophthalmological examinations and adverse events at monthly follow-up visits .


Efficacy analysis included change from baseline in best-corrected VA ( BCVA ) based on descriptive statistics .


A total of @,@ patients were enrolled throughout Germany and @,@ patients ( mean age @ years , @ % women ) comprised the efficacy population with a complete set of data .


In the clinical setting recorded in our study , only a minority of patients underwent optical coherence tomography during the maintenance phase ( @ of @,@ patients ) .


Patients received a mean total of @ injections ; three injections during upload phase and @ additional injections during maintenance phase .


Over half of the patients ( @ % ) did not receive additional injections .


Mean decimal BCVA increased during the upload phase , ( from LogMAR mean of @ at baseline to @ at Month @ ) but displayed a decline over time ( @ at Month @ ) .


Ranibizumab treatment in a real-life setting demonstrated efficacy in neovascular AMD patients , as shown by initial gains in BCVA .


However , maintenance and improvement of these gains during the maintenance phase in a clinical routine setting remained below those expected compared with MARINA , ANCHOR and CATT trials , most likely due to a low number of retreatments , and the high number of patients with a poor response in regard to improvements of VA who were not investigated in these studies .


To assess whether a strategy of endovascular repair ( if aortic morphology is suitable , open repair if not ) versus open repair reduces early mortality for patients with suspected ruptured abdominal aortic aneurysm .


Randomised controlled trial .


@ vascular centres ( @ UK , @ Canadian ) , @-@ .


@ eligible patients ( @ men ) with a clinical diagnosis of ruptured aneurysm .


@ patients were randomised to the endovascular strategy ( @ confirmed ruptures , @ anatomically suitable for endovascular repair ) and @ to open repair ( @ confirmed ruptures ) .


@ day mortality , with @ hour and in-hospital mortality , costs , and time and place of discharge as secondary outcomes .


@ day mortality was @ % ( @/@ ) in the endovascular strategy group and @ % ( @/@ ) in the open repair group : odds ratio @ ( @ % confidence interval @ to @ ; P = @ ) ; odds ratio after adjustment for age , sex , and Hardman index @ ( @ to @ ) .


Women may benefit more than men ( interaction test P = @ ) from the endovascular strategy : odds ratio @ ( @ to @ ) versus @ ( @ to @ ) .


@ day mortality for patients with confirmed rupture was @ % ( @/@ ) in the endovascular strategy group and @ % ( @/@ ) in the open repair group ( P = @ ) .


More patients in the endovascular strategy than in the open repair group were discharged directly to home ( @/@ ( @ % ) v @/@ ( @ % ) ; P < @ ) .


Average @ day costs were similar between the randomised groups , with an incremental cost saving for the endovascular strategy versus open repair of @ ( @ ; $ @ ) ( @ % confidence interval -@ to @ ) .


A strategy of endovascular repair was not associated with significant reduction in either @ day mortality or cost .


Longer term cost effectiveness evaluations are needed to assess the full effects of the endovascular strategy in both men and women .


To observe the clinical efficacy of bevacizumab concomitant with pemetrexed in patients with advanced non-small cell lung cancer ( NSCLC ) .


A total of @ patients were randomly divided into a combination group ( pemetrexed + bevacizumab , n = @ ) and a pemetrexed group ( n = @ ) and assessed for disease control ( CR+PR+SD ) after @-cycles of first-line GP chemotherapy ( gemcitabine + cisplatin ) .


Clinical efficacy , progression-free survival time ( PFS ) , overall survival time ( OS ) , overall response rate ( ORR ) , disease control rate ( DCR ) and rate of adverse responses between two groups were observed and compared .


ORR and DCR were @ % and @ % in combination group , and @ % and @ % in the pemetrexed group , respectively , but there were no significant differences ( P > @ ) .


PFS in combination group and pemetrexed group were @ months and @ months respectively ( P = @ ) , whereas OS in the combination group was @ months , evidently higher than in the pemetrexed group ( @ months , P = @ ) .


Adverse responses in both groups included high blood pressure , bleeding , thrombocytopenia , anemia , elevated transaminase , diarrhea , vomiting and proteinuria , but there were no significant differences ( P > @ ) .


Bevacizumab concomitant with pemetrexed has better clinical efficacy and safety , giving rise to prolonged survival time in patients with advanced NSCLC .


To compare the differences in clinical efficacy on peripheral facial paralysis at acute stage between the opposing needling technique and routine acupuncture at the affected side so as to provide the evidence on the acupuncture treatment for peripheral facial paralysis at acute stage .


Forty patients were rando - mized into an opposing needling technique group ( @ cases ) and an affected side needling technique group ( @ cases ) .


The basic medication was same in the two groups .


The acupoints were Fengchi ( GB @ ) , Yangbai ( GB @ ) to Yuyao ( EX-HN @ ) ( penetrating needling method ) , Jingming ( BL @ ) , Chengqi ( ST @ ) , Xiaguan ( ST @ ) , Jiache ( ST @ ) to Dicang ( ST @ ) , Hegu ( LI @ ) and Zusanli ( ST @ ) .


In supplementation , in the opposing needling technique group , the acupoints were stimulated on the face of healthy side .


In the affected side needling technique group , the acupoints were stimulated on the face of the affected side .


The treatment was given three times a week , for @ weeks .


House-Brackmann ( H-B ) facial nerve function assessment was used to evaluate facial nerve function before and after treatment in the patients of the two groups .


The efficacy was compared between the two groups .


The facial nerve function was recovered in the two groups and the total effective rate was @ % in the two groups ( P > @ ) .


The curative rate was @ % ( @/@ ) in the opposing needling technique group and better than @ % ( @/@ ) in the affected side needling technique group ( P < @ ) .


On the @th and @th day , scores of H-B in the opposing needling technique group were better than those in the affected side needling technique group ( both P < @ ) .


The curative time in the opposing needling technique group was apparently shorter than that in the affected side needling technique group ( ( @ + / - @ ) days vs. ( @ + / - @ ) days , P < @ ) .


The opposing needling technique accelerates the recovery of facial nerve function in peripheral facial paralysis at acute stage and apparently shortens the curative time .


The efficacy is better than that in acupuncture on the affect - ed side of the face .


We used quantitative coronary angiography ( QCA ) to investigate whether coronary plaque progression can be inhibited by controlling lipids with rosuvastatin at Japanese standard doses following elective percutaneous coronary intervention ( PCI ) .


A total of @ patients who underwent elective PCI were randomized to either the rosuvastatin ( @ or @ mg/day ) or non-statin group .


Changes from baseline in the minimal lumen diameter ( MLD ) and average lumen diameter ( ALD ) measured using QCA were analyzed in both target and non-target lesions .


The changes in MLD and ALD from baseline to @ months in the non-target lesions were significantly smaller in the rosuvastatin group than in the non-statin group ( -@ @ mm vs.-@ @ @ mm , p = @ ; -@ @ mmvs .


-@ @ mm , p = @ ) .


The changes in MLD from six to @ months in the target lesions were significantly lower in the rosuvastatin group than in the non-statin group among the patients treated with drug-eluting stents ( -@ @ mm vs. -@ @ mm , p = @ ) versus those treated with bare-metal stents ( -@ @ mm vs. -@ @ mm , p = @ ) .


The present study demonstrated that the administration of a standard dose of rosuvastatin slows coronary plaque progression and may prevent the late catch-up phenomenon associated with drug-eluting stents in patients who undergo elective PCI .


Naturally occurring gastrointestinal disease is an important cause of acute hypoproteinemia in adult horses and hydroxyethyl starch colloid fluid treatment is a component of supportive care in these cases to improve plasma volume and maintain colloid osmotic pressure ( COP ) .


The objectives of the present study were to compare @ formulations of high molecular weight hydroxyethyl starch and their relative effect on COP , acid-base status , and survival of horses with acute hypoproteinemia secondary to gastrointestinal disease .


Twenty adult horses , @ year of age , were prospectively enrolled , with informed client consent , if they developed acute hypoproteinemia , defined as a plasma total protein < @ g/dL or albumin < @ g/dL during hospitalization while undergoing treatment for gastrointestinal disease .


Horses were randomly assigned to receive a rapid infusion of either @ % hydroxyethyl starch in @ % saline or @ % hydroxyethyl starch in lactated ringers solution at a dose of @ ml/kg .


Venous blood gas analysis , COP , and PCV were evaluated before and after colloid administration .


For both groups , average COP prior to treatment was @ mmHg ( @ - @ mmHg ) and post colloid treatment was @ mmHg ( @ -@ mmHg ) -LSB- Normal range @ - @ mmHg -RSB- .


COP was significantly increased with colloid treatment ( p < @ ) but this increase was not significantly different between treatment groups .


Venous pH did not change significantly with treatment .


Twelve horses survived to hospital discharge and survival did not differ significantly between treatment groups .


Post-treatment COP improved approximately @ % regardless of the formulation used , however , values did not reach the normal range of COP observed in healthy horses .


Acid-base parameters were not significantly impacted by either treatment .


Further study is needed to determine how these two products compare with regards to other outcome measures .


Evaluation of the relative effects of colloid formulation in horses with clinical disease is a future area of interest .


To assess the cardiorespiratory parametes , recovery , gastrointestinal motility and serum cortisol concentrations in horses anesthetized with isoflurane with or without a continuous rate infusion ( CRI ) of butorphanol for orchiectomy .


Twelve adult , intact , male horses weighing @ @ kg were included in the study .


Xilazine was administered as premedication .


Anesthesia was induced with ketamine and midazolam and maintained with isoflurane .


Butorphanol ( @ mg kg-@ bolus ) or an equivalent volume of saline ( @ % ) was given intravenously followed by a CRI of butorphanol ( BG ) ( @ g kg-@ hour-@ ) or saline ( CG ) .


Cardiorespiratory variables were recorded before ( T@ ) and every @ minutes for @ minutes after the start of infusion .


Serum cortisol concentration was measured at T@ and @ minutes , and @ minutes and @ hours after the horse stood up .


Recovery from anesthesia was evaluated using a scoring system .


Gastrointestinal motility was evaluated before anesthesia and during @ hours after recovery .


There were no significant differences between groups in cardiopulmonary variables , or recovery scores or serum cortisol concentrations .


A reduction in gastrointestinal motility was recorded for @ minutes in BG .


Continuous rate infusion of butorphanol in horses anesthetized with isoflurane did not adversely affect the cardiopulmonary variables monitored , or recovery scores .


A small but statistically significant reduction in gastrointestinal motility occurred in the butorphanol group .


The @ serotypes of dengue virus , DENV-@-@ , are the leading cause of arboviral disease globally .


The ideal dengue vaccine would provide protection against all serotypes after a single dose .


Two randomized , placebo-controlled trials were performed with @ flavivirus-naive adults to demonstrate the safety and immunogenicity of a live attenuated tetravalent dengue vaccine ( TV@ ) , compared with those of a second tetravalent vaccine with an enhanced DENV-@ component ( TV@ ) , and to evaluate the benefit of a booster dose at @ months .


Safety data , viremia , and neutralizing antibody titers were evaluated .


A single dose of TV@ elicited a tetravalent response in @ % of vaccinees by @ months after vaccination and a trivalent response in @ % .


Compared with TV@ , the higher-dose DENV-@ component increased the observed frequency of immunogenicity to DENV-@ in the TV@ trial .


Both the first and second doses were well tolerated .


Neither vaccine viremia , rash , nor a significant antibody boost were observed following a second dose .


A single subcutaneous dose of TV@ dengue vaccine is safe and induces a tetravalent antibody response at an unprecedented frequency among vaccinees .


A second dose has limited benefit and appears to be unnecessary .


Studies to confirm these findings and assess vaccine efficacy will now move to populations in regions where DENV transmission is endemic .


To compare survival , tumor control , toxicities , and quality of life of patients with locally advanced nasopharyngeal carcinoma ( NPC ) treated with induction chemotherapy and concurrent chemo-radiation ( CCRT ) , against CCRT alone .


Patients were stratified by N stage and randomized to induction GCP ( @ cycles of gemcitabine @mg/m ( @ ) , carboplatin area under the concentration-time-curve @ , and paclitaxel @mg/m ( @ ) given days @ and @ every @days ) followed by CCRT ( radiation therapy @ Gy with weekly cisplatin @mg/m ( @ ) ) , or CCRT alone .


The accrual of @ was planned to detect a @ % difference in @-year overall survival ( OS ) with a @ % significance level and @ % power .


Between September @ and August @ , @ patients were accrued , and @ ( GCP @ , control @ ) were analyzed by intention to treat .


There was no significant difference in OS ( @-year OS @ % -LSB- GCP -RSB- vs @ % -LSB- control -RSB- ; hazard ratio @ ; @-sided P = @ -RSB- ) , disease-free survival ( hazard ratio @ , @ % confidence interval @-@ @ , P = @ ) , and distant metastases-free survival ( hazard ratio @ , @ % confidence interval @-@ @ , P = @ ) between the @ arms .


Treatment compliance in the induction phase was good , but the relative dose intensity for concurrent cisplatin was significantly lower in the GCP arm .


Overall , the GCP arm had higher rates of grades @ and @ leukopenia ( @ % vs @ % ) and neutropenia ( @ % vs @ % ) , but grade @ and @ acute radiation toxicities were not statistically different between the @ arms .


The global quality of life scores were comparable in both arms .


Induction chemotherapy with GCP before concurrent chemo-irradiation did not improve survival in locally advanced NPC .


Pregnancy-associated plasma protein A ( PAPP-A ) has prognostic impact in pregnancy and acute coronary syndrome .


Patients with chronic kidney disease have an excessive cardiovascular risk .


In an effort to identify novel risk factors for cardiovascular disease , we investigated the relationship of PAPP-A with specific outcomes in diabetic patients undergoing dialysis .


PAPP-A was measured in @ diabetic hemodialysis patients , who participated in the German Diabetes and Dialysis Study and followed-up for a median of @ years .


By Cox regression analysis , we assessed the association of baseline levels of PAPP-A with all-cause mortality , combined cardiovascular events and the specific outcomes of sudden death , stroke , myocardial infarction and infectious mortality .


Patients had a mean age of @ years ( @ % male ) and median PAPP-A concentration of @mIU/L ( IQR @-@ @ mIU/L ) .


Per standard deviation increase in PAPP-A the adjusted risk of sudden cardiac death increased by @ % ( HR @ , @ % CI @-@ @ ) .


Categorical analyses showed that the patients in the @ ( th ) PAPP-A quartile had an adjusted @ fold increased risk of sudden death and @ fold increased risk of stroke as compared to the patients in the @st quartile .


Similarly , the risk of combined cardiovascular events was significantly elevated by the factor @ in patients of the @ ( th ) quartile .


Additionally , PAPP-A levels were associated with infectious deaths and all-cause mortality .


PAPP-A is associated with sudden death , stroke and infectious complications in diabetic dialysis patients .


PAPP-A may be useful for risk assessment and monitoring in populations at high risk of cardiovascular events .


Home respiratory polygraphy ( HRP ) may be a cost-effective alternative to polysomnography ( PSG ) for diagnosis and treatment election in patients with high clinical probability of obstructive sleep apnea ( OSA ) , but there is conflicting evidence on its use for a wider spectrum of patients .


To determine the efficacy and cost of OSA management ( diagnosis and therapeutic decision making ) using ( @ ) PSG for all patients ( PSG arm ) ; ( @ ) HRP for all patients ( HRP arm ) ; and ( @ ) HRP for a subsample of patients with high clinical probability of being treated with continuous positive airway pressure ( CPAP ) and PSG for the remainder ( elective HRP arm ) .


Multicentric study of @ patients with intermediate-high clinical probability of OSA , randomly subjected to HRP and PSG .


We explored the diagnostic and therapeutic decision agreements between the PSG and both HRP arms for several HRP cutoff points and calculated costs for equal diagnostic and/or therapeutic decision efficacy .


For equal diagnostic and therapeutic decision efficacy , PSG arm costs were @ % higher than HRP arm costs and @ % higher than elective HRP arm costs .


HRP arm costs tended to be lower than elective HRP arm costs , and both tended to be lower than PSG arm costs if patient costs were omitted .


Home respiratory polygraphy is a less costly alternative than polysomnography for the diagnosis and therapeutic decision making for patients with suspected obstructive sleep apnea .


We found no advantage in cost terms , however , in using home respiratory polygraphy for all patients or home respiratory polygraphy for the most symptomatic patients and polysomnography for the rest .


The authors assessed the efficacy and safety of combination treatment with varenicline and sustained-release bupropion for smokers who , based on an assessment of initial smoking reduction prior to the quit date , were deemed unlikely to achieve abstinence using nicotine patch treatment .


In a randomized , double-blind , parallel-group adaptive treatment trial , the authors identified @ cigarette smokers who failed to show a reduction of more than @ % in smoking after @ week of nicotine patch treatment .


Smokers were randomly assigned to receive @ weeks of varenicline plus bupropion or varenicline plus placebo .


The primary outcome measure was continuous smoking abstinence at weeks @-@ after the target quit date .


Both treatments were well tolerated .


Participants who received the combination treatment had a significantly higher abstinence rate than those who received varenicline plus placebo ( @ % compared with @ % ; odds ratio = @ ; @ % CI = @ , @ ) .


Combination treatment had a significantly greater effect on abstinence rate in male smokers ( odds ratio = @ ; @ % CI = @ , @ ) than in female smokers ( odds ratio = @ ; @ % CI = @ , @ ) .


It also had a significantly greater effect in highly nicotine-dependent smokers ( odds ratio = @ , @ % CI = @ , @ ) than in smokers with lower levels of dependence ( odds ratio = @ , @ % CI = @ , @ ) .


Among smokers who did not show a sufficient initial response to prequit nicotine patch treatment , combination treatment with varenicline and bupropion proved more efficacious than varenicline alone for male smokers and for smokers with a high degree of nicotine dependence .


Nonalcoholic steatohepatitis ( NASH ) is common and severe in patients with diabetes mellitus .


Although , there are no effective treatments for NASH in diabetic patients , preliminary reports suggest that polyunsaturated fatty acids ( PUFA ) may be beneficial in these patients .


A prospective , randomized , double-blind placebo-controlled study ( NCT @ ) was performed in NASH patients with diabetes .


Clinicaltrials.gov ( NCT @ ) .


A total of @ patients ( @ @ y ) with well-controlled diabetes ( HbA@C < @ % ) were randomized to receive either PUFA containing eicosapentaenoic acid ( @ mg ) and docosahexaenoic acid ( @ mg ) daily or an isocaloric , identical placebo containing corn oil for @ weeks under CONSORT guidelines .


Clinical , demographics , biochemical laboratory tests , body composition using DEXA , and liver biopsy were performed at randomization and at the end of treatment .


Liver biopsy was scored by the NASH CRN criteria .


An intention-to-treat analysis was performed .


At inclusion , sex , age , body weight , biochemical tests , glucose control , and liver histology were similar in the @ treatment groups .


There was no change in liver enzymes , body weight , or body composition during the study in either group .


At the end of the treatment , hepatic steatosis and the activity score improved ( P < @ ) and lobular inflammation worsened ( P < @ ) with placebo but was unchanged with PUFA .


At the end of the treatment , insulin resistance ( serum glucose and HOMA ) worsened with PUFA but not placebo .


PUFA provided no benefit over placebo in NASH patients with diabetes .


The effects of PUFA on histology and insulin resistance were inferior to placebo .


These data provide no support for PUFA supplements in NASH .


Pomaglumetad methionil ( LY@ monohydrate ) is a potent and highly selective agonist for the metabotropic glutamate mGluR@ and mGluR@ receptors .


We present results of a pivotal clinical study H@Y-MC-HBBM assessing the efficacy of LY@ in improving symptoms as a monotherapy in patients with an acute exacerbation of schizophrenia .


Enrolled adult patients ( ages @-@ ) with schizophrenia who had experienced an exacerbation of symptoms within @weeks prior to study entry .


Patients ( N = @ ) were randomized @:@:@:@ to treatment with placebo , LY@ mg twice daily ( BID ) , LY@ mg BID , or risperidone ( RIS ) @mg BID for @weeks after a one-week blinded placebo lead-in .


The primary outcome assessed change from baseline in the Positive and Negative Syndrome Scale ( PANSS ) total score in an overall schizophrenia population and a predefined subpopulation which excluded non-Hispanic white patients with the A/A genotype at the HTR@A SNP rs@ .


Neither LY@ dose showed significant improvement compared to placebo on PANSS total in either population ( @-sided p-value -LSB- significance level -RSB- , overall : LY@ , p = @ -LSB- @ -RSB- ; LY@ , p = @ -LSB- @ -RSB- , subpopulation : LY@ , p = @ -LSB- @ -RSB- ; LY@ , p = @ -LSB- @ -RSB- , MMRM analysis ) .


RIS statistically separated from placebo in both populations ( p < @ -LSB- @ -RSB- ) .


There were no statistically significant differences in the incidence of serious adverse events , and no seizures on LY@ .


LY@ treatment did not demonstrate efficacy in populations studied .


Overall , LY@ treatment was generally well tolerated with no new adverse safety findings compared to previous trials .


Further understanding of the role of glutamate as a therapeutic target in schizophrenia is needed .


To test the hypothesis that experimental pain in the masseter muscle or temporomandibular joint ( TMJ ) will decrease the anterior maximum voluntary bite force ( MVBF ) and jaw muscle activity in relation to the perceived effort .


Sixteen volunteers participated in two experimental sessions .


Participants were injected with @ mL of monosodium glutamate ( @ M ) into either the masseter muscle or TMJ .


The MVBF and corresponding electromyographic ( EMG ) activity of the masseter , anterior temporalis , and digastric muscles were recorded @ times at an interval of @ minutes before and after injection .


Pain was measured using a visual analog scale and McGill Pain Questionnaire .


In addition , participants were asked how they perceived the interference of pain on their biting performance .


The data analysis included a two-way analysis of variance model and t test .


There was no significant difference in peak pain intensity ( P = @ ) and duration of pain ( P = @ ) between painful muscle and TMJ injections , but TMJ injection produced a significantly larger area under the curve ( P = @ ) and a significantly higher pain rating index ( P = @ ) .


Pain in the muscle ( P = @ ) and TMJ ( P = @ ) did not significantly change the MVBF from baseline levels .


The EMG activity also did not differ significantly from baseline levels during muscle pain .


However , there was a significant increase ( P = @ ) in the EMG activity of the anterior temporalis and a significant decrease ( P = @ ) in the EMG activity of the anterior digastric muscle compared to baseline during TMJ pain .


Subject-based reports also revealed that in the majority of cases ( @ % ) , pain did not interfere with the MVBF task .


Experimental pain from either masseter muscle or TMJ did not affect the MVBF , in accordance with the subject-based reports .


Jaw muscle activity , except for EMG activity of the anterior temporalis and anterior digastric muscles during TMJ pain , also remained unaffected by pain .


The findings suggest that it is not pain in itself but rather how pain is perceived that may lead to adaptation of motor function , supporting an integrated pain adaptation model .


Physical inactivity contributes to poor fitness and mental health disorders .


This is of concern in post-conflict low-income settings where non-communicable diseases are emerging and there is limited evidence for physical activity interventions .


We examined the effects of a sport-for-development programme on adolescent physical fitness and mental health in Gulu , Uganda .


We conducted a single-blinded RCT nested within an observational study with three unbalanced parallel groups .


Participants were able-bodied adolescents aged @-@ years .


The intervention comprised an @-week voluntary competitive sport-for-development football league .


Participants who did not subscribe for the intervention formed a non-registered comparison group .


Boys who registered for the sport-for-development programme were randomly allocated to the intervention or wait-listed .


The girls programme subscription was insufficient to form a wait-list and all registrants received the intervention .


Physical fitness was assessed by cardiorespiratory fitness ( multi-stage fitness test ) , muscular power ( standing broad jump ) and body composition ( BMI-for-age ) .


Mental health was measured using the Acholi Psychosocial Assessment Instrument for local depression-like ( DLS ) and anxiety-like ( ALS ) syndromes .


All randomisation was computer generated and assessors were masked to group allocation .


An intention-to-treat analysis of adjusted effect size ( ES ) was applied .


There were @,@ adolescents in the study ( intervention : boys = @ , girls = @ ; wait-list : boys = @ ; comparison : boys = @ , girls = @ ) .


At four months follow-up there was no significant effect on the boys fitness when comparing intervention vs wait-listed and intervention vs non-registered groups .


However , there was a negative effect on DLS when comparing boys intervention vs wait-listed ( ES = @ -LSB- @ to @ -RSB- ) and intervention vs non-registered ( ES = @ -LSB- @ to @ -RSB- ) .


Similar results were observed for ALS for boys intervention vs wait-listed ( ES = @ -LSB- @ to @ -RSB- ) and intervention vs non-registered ( ES = @ -LSB- @ to @ -RSB- ) .


There was no significant effect on the girls for any outcomes .


The sport-for-development league in this study had no impact on fitness and a negative effect on the mental health of participating boys .


From this research , there is no evidence that voluntary competitive sport-for-development interventions improve physical fitness or mental health outcomes in post-conflict settings .


To evaluate the effect of topical haemoglobin spray on treatment response and wound-closure rates in patients with chronic venous leg ulcers .


A linear regression model was used to forecast healing outcomes over a @-month period .


Simulated data were taken from normal distributions based on post-hoc analysis of a @-patient study in non-healing and worsening wounds ( @ patients receiving standard care and @ receiving standard care plus topical haemoglobin spray ) .


Using a simulated @,@ ` patients ' from each group , the proportion of wound closure over time was projected .


Simulation results predicted a @ % wound closure rate at six months in the haemoglobin group , compared with @ % in the standard care group .


Over a @-month simulation period , a @ % overall reduction in wound burden was predicted .


With the haemoglobin spray , @ % of wounds were expected to heal in @ months , compared with @ % in the standard care group .


Topical haemoglobin spray promises a more effective treatment for chronic venous leg ulcers than standard care alone in wounds that are non-healing or worsening .


Further research is required to validate these predictions and to identify achievable outcomes in other chronic wound types .


Immune globulin intravenous ( IGIV ) , @ % is a donor-derived polyclonal human immunoglobulin G antibody mixture that has potent immune modulatory properties and contains conformation selective anti-amyloid antibodies .


We evaluated the safety and tolerability of multiple doses of IGIV , @ % in Japanese patients with mild to moderate Alzheimer 's disease .


Among the @ subjects , @ subjects were assigned to the IGIV group and @ subjects to the placebo group .


Subjects received a total of six infusions of either IGIV at a dose of @ or @ g/kg , or placebo every @ weeks .


A total of @ treatment-emergent adverse events ( TEAE ) occurred in @ subjects : @ TEAE in five subjects in both the IGIV @ and @ g/kg groups , and @ TEAE in four subjects in the placebo group .


The most common TEAE in the IGIV subjects were nasopharyngitis , injection-site swelling , and erythema .


All @ TEAE in the IGIV group were considered to be mild .


Only one mild TEAE ( rash ) was considered to be possibly related to the study drug .


There were no significant differences in incidence of TEAE between the treatment groups .


Four serious TEAE were reported , and all of these were considered to be unrelated to the study treatment .


Other assessments related to safety revealed neither clinically significant abnormal values nor findings in the study .


IGIV is generally safe and well tolerated with multiple intravenous infusions at doses of @ g/kg and @ g/kg in Japanese patients with mild to moderate Alzheimer 's disease .


Ghrelin has glucoregulatory and orexigenic actions , but its role in acute hypoglycemia remains uncertain .


We aimed to investigate circulating levels of acylghrelin ( AG ) and unacylated ghrelin ( UAG ) in response to hyperinsulinemia and to hypoglycemia .


A randomized , single-blind , placebo-controlled crossover study including @ study days was performed at a university hospital clinical research center .


Nine healthy men completed @ study days : i ) saline control ( CTR ) , ii ) hyperinsulinemic euglycemia ( HE ) ( bolus insulin @ IE/kg i.v. and glucose @ % i.v. for @min , plasma glucose @mmol/l ) , and iii ) hyperinsulinemic hypoglycemia ( HH ) ( bolus insulin @ IE/kg i.v. ) .


HH and HE suppressed AG concentrations at t = @-@min as compared with CTR ( P < @ ) .


At t = @min , a rebound increase in AG was observed in response to HH as compared with both HE and CTR ( P < @ ) .


UAG also decreased during HH and HE at t = @min ( P < @ ) , whereas the AG-to-UAG ratio remained unaffected .


This study demonstrates that AG and UAG are directly suppressed by hyperinsulinemia and that AG concentrations increase after a latency of @h in response to hypoglycemia , suggesting a potential counterregulatory role of AG .


Fluconazole prophylaxis has demonstrated efficacy in single and multicenter randomized controlled trials without side effects or emergence of resistance .


Additional evidence based on incidence of invasive Candida infections , multicenter data , resistance , and safety is desired .


We conducted a case-control analysis of efficacy and safety of fluconazole prophylaxis from a multicenter database from a neonatal infection study that included @ infants < @ grams from @ NICUs .


Infants receiving intravenous antifungal prophylaxis were pre-identified during enrollment in the parent study .


For each infant receiving antifungal prophylaxis ( case ) , three infants not receiving antifungal ( controls ) were matched by birth weight ( @ g ) , by gestational age ( @ week ) , gender , and study site .


Fluconazole prophylaxis was administered to @ patients -LSB- @ @ g birth weight ( BW ) and @ @ weeks gestational age ( GA ) -RSB- and were compared with @ control patients ( @ @ g BW and @ @ weeks GA ) .


Invasive Candida infection occurred in @ % ( @ of @ ) infants who received fluconazole prophylaxis compared with @ % ( @ of @ ) of matched controls ( p = @ ) .


Candida bloodstream infection occurred in @ % ( @ of @ ) fluconazole prophylaxis infants compared with @ % ( @ of @ ) of matched controls ( p = @ ) .


There were no differences in late-onset sepsis due to gram-positive or gram-negative organisms , focal bowel perforation , necrotizing enterocolitis , cholestasis , or overall mortality .


Fluconazole prophylaxis is safe and efficacious in preventing invasive Candida infections .


Even in NICUs with a low incidence of invasive Candida infections , antifungal prophylaxis for high-risk infants is a proven and safe opportunity for infection prevention in these patients .


There is substantial debate regarding the development of acute coronary syndrome in patients using proton pump inhibitors ( PPIs ) combined with clopidogrel .


However , data remain limited to address the effect of PPIs alone on the subsequent risk of myocardial infarction ( MI ) .


We aimed to explore the subsequent risk of MI in PPI users who had no previous history of MI .


The records of inpatients and outpatients with PPI prescriptions were retrieved from the Taiwan National Health Insurance Research Database between @ and @ .


We conducted two different study designs , the first using propensity score ( PS ) - matching analyses and the second using case-crossover analyses .


The risk of developing MI for PPI users was analyzed in the PS-matched study .


The association between risk of MI and prior PPI exposure was further validated in the case-crossover study .


In the PS-matched study , we included @,@ PPI users and @,@ PS-matched PPI non-users .


After @ days of follow-up , PPI use was associated with a @-fold greater risk of MI ( adjusted hazard ratio -LSB- HR -RSB- = @ , @ % confidence interval -LSB- CI -RSB- = @ to @ ) .


In the case-crossover study , adjusted odds ratios of PPI for MI risk were @ ( @ % CI = @ to @ ) for the @-day window and @ ( @ % CI = @ to @ ) for the @-day window .


Use of PPIs may be independently associated with an increased risk of MI .


However , the benefits of PPIs may greatly outweigh the risks of adverse cardiovascular effects , with number needed to harm of @ .


Noninvasive electrical brain stimulation ( NEBS ) with transcranial direct current ( tDCS ) or random noise stimulation ( tRNS ) applied to the primary motor cortex ( M@ ) can augment motor learning .


We tested whether different types of stimulation alter particular aspects of learning a tracing task over three consecutive days , namely skill acquisition ( online/within session effects ) or consolidation ( offline/between session effects ) .


Motor training on a tracing task over three consecutive days was combined with different types and montages of stimulation ( tDCS , tRNS ) .


Unilateral M@ stimulation using tRNS as well as unilateral and bilateral M@ tDCS all enhanced motor skill learning compared to sham stimulation .


In all groups , this appeared to be driven by online effects without an additional offline effect .


Unilateral tDCS resulted in large skill gains immediately following the onset of stimulation , while tRNS exerted more gradual effects .


Control stimulation of the right temporal lobe did not enhance skill learning relative to sham .


The mechanisms of action of tDCS and tRNS are likely different .


Hence , the time course of skill improvement within sessions could point to specific and temporally distinct interactions with the physiological process of motor skill learning .


Exploring the parameters of NEBS on different tasks and in patients with brain injury will allow us to maximize the benefits of NEBS for neurorehabilitation .


Combined-modality treatment is standard treatment for patients with clinical stage I/II Hodgkin lymphoma ( HL ) .


We hypothesized that an early positron emission tomography ( PET ) scan could be used to adapt treatment .


Therefore , we started the randomized EORTC/LYSA/FIL Intergroup H@ trial evaluating whether involved-node radiotherapy ( IN-RT ) could be omitted without compromising progression-free survival in patients attaining a negative early PET scan after two cycles of ABVD ( doxorubicin , bleomycin , vinblastine , and dacarbazine ) as compared with standard combined-modality treatment .


Patients age @ to @ years with untreated clinical stage I/II HL were eligible .


Here we report the clinical outcome of the preplanned interim futility analysis scheduled to occur after documentation of @ events in the early PET-negative group .


Because testing for futility in this noninferiority trial corresponds to testing the hypothesis of no difference , a one-sided superiority test was conducted .


The analysis included @,@ patients .


In the favorable subgroup , @ % had a negative early PET scan ( standard arm , one event v experimental arm , nine events ) .


In the unfavorable subgroup , @ % had a negative early PET scan ( standard arm , seven events v experimental arm , @ events ) .


The independent data monitoring committee concluded it was unlikely that we would show noninferiority in the final results for the experimental arm and advised stopping random assignment for early PET-negative patients .


On the basis of this analysis , combined-modality treatment resulted in fewer early progressions in clinical stage I/II HL , although early outcome was excellent in both arms .


The final analysis will reveal whether this finding is maintained over time .


Orteronel ( TAK-@ ) is an investigational , nonsteroidal , reversible , selective @,@-lyase inhibitor .


This study examined orteronel in patients with metastatic castration-resistant prostate cancer that progressed after docetaxel therapy .


In our study , @,@ men were randomly assigned in a @:@ schedule to receive orteronel @ mg plus prednisone @ mg twice daily or placebo plus prednisone @ mg twice daily , stratified by region ( Europe , North America -LSB- NA -RSB- , and non-Europe/NA ) and Brief Pain Inventory-Short Form worst pain score .


Primary end point was overall survival ( OS ) .


Key secondary end points ( radiographic progression-free survival -LSB- rPFS -RSB- , @ % decrease of prostate-specific antigen -LSB- PSA@ -RSB- , and pain response at @ weeks ) were to undergo statistical testing only if the primary end point analysis was significant .


The study was unblinded after crossing a prespecified OS futility boundary .


The median OS was @ months versus @ months with orteronel-prednisone versus placebo-prednisone ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ; P = @ ) .


Improved rPFS was observed with orteronel-prednisone ( median , @ v @ months ; HR , @ ; @ % CI , @ to @ ; P < @ ) .


Orteronel-prednisone showed advantages over placebo-prednisone in PSA@ rate ( @ % v @ % , P < @ ) and time to PSA progression ( median , @ v @ months , P < @ ) but not pain response rate ( @ % v @ % ; P = @ ) .


Adverse events ( all grades ) were generally more frequent with orteronel-prednisone , including nausea ( @ % v @ % ) , vomiting ( @ % v @ % ) , fatigue ( @ % v @ % ) , and increased amylase ( @ % v @ % ) .


Our study did not meet the primary end point of OS .


Longer rPFS and a higher PSA@ rate with orteronel-prednisone indicate antitumor activity .


To compare the effectiveness of bupivacaine moistened dressing and conventional dressing in patients requiring split thickness skin graft for reconstruction of various defects .


Randomized controlled trial .


Department of Plastic Surgery and Burns Unit , Mayo Hospital , King Edward Medical University , Lahore , from January @ to January @ .


One hundred and fifty patients requiring split thickness skin grafting for various soft tissue defects were divided into two groups A and B , with @ patients in each group .


In Group A , skin graft donor site dressing was kept moist with @ mL/@ cm@ of @ % bupivacaine solution and in Group B , dressing was moistened with same amount of normal saline .


Outcome was measured by calculating rescue analgesia requirements in the two groups after @ hours .


Significance was determined by comparing analgesia sparing effect of each dressing using chi-square test .


In Group A , @ out of @ ( @ % ) patients required rescue analgesia .


In Group B , @ out of @ ( @ % ) patients required rescue analgesia ( p < @ ) .


There was @ % effectiveness of bupivacaine soaked dressing while only @ % effectiveness of conventional dressing .


Bupivacaine soaked dressing is much more effective in pain relief and in reducing the requirement of rescue analgesia , in early postoperative period , at split thickness skin graft donor site compared to the conventional dressing .


Unstable steel wire cerclage following open heart surgery may result in increased pain , sternal cut-through , non-union , or dehiscence .


These complications lead to longer hospital stays , increased cost , higher morbidity , and patient dissatisfaction .


The Figure @ FlatWire Sternal Closure System is a new construct which is a simple , intuitive , and inexpensive alternative for primary sternal repair following open heart surgery .


Prior bench-top testing of FlatWire has demonstrated superior strength and stiffness compared to traditional steel wire .


We present our initial experience in a prospective , randomized , single blinded pilot study utilizing this FDA approved system .


Sixty-three patients undergoing elective complete sternotomies at a single institution were randomly assigned to receive either the Figure @ FlatWire or standard steel wire cerclage .


All surgeries were performed by a single board certified cardiothoracic surgeon .


Data collected included : Age , BMI , pump time , off pump to surgical stop time , length of hospital stay after surgery , cost from time of surgery to discharge , and pain on a visual analog pain scale on the day of discharge , day @ , and day @ .


The groups were well matched .


Patients receiving the Figure @ FlatWire ( @ ) had a reduction in length of stay compared to patients receiving steel wire circlage ( @ ) , but it was not statistically significant ( @ vs. @ days respectively , p < @ ) .


Additionally those with the FlatWire reported significantly decreased pain at day of discharge ( @ vs. @ points on pain scale , p < @ ) , with similar pain scores at @ and @days .


Off pump to surgery stop time was increased by @ minutes in patients receiving the FlatWire vs. steel wires ( @ vs. @ minutes , p = @ ) .


Mean cost from surgery until discharge was $ @,@ in the FlatWire group vs. $ @,@ in the steel wire group ( p < @ ) .


Early clinical results suggest that Figure @ FlatWire provides excellent stability , which resulted in significantly diminished postoperative pain at discharge .


Although not significant there was a trend toward decreased length of stay , and reduced cost .


Further clinical research is warranted to expand upon these initial trends and validate long term outcomes .


Insulin resistance is associated with blunted sympathetic nervous system ( SNS ) response to carbohydrate ingestion which may contribute to postprandial hypotension and impaired body weight homeostasis .


This study was conducted to examine the effects of pharmacological insulin sensitization on whole-body norepinephrine kinetics during a standard @-g oral glucose tolerance test ( OGTT ) in obese , insulin resistant subjects with metabolic syndrome .


Un-medicated individuals ( n = @ , mean age @ yrs , body mass index @ kg/m ( @ ) ) were randomised to @-weeks pioglitazone ( PIO , @ mg for @ weeks , then @ mg daily ) or placebo using a double-blind , parallel group design .


Whole-body norepinephrine kinetics ( arterial norepinephrine concentration , calculated spillover and clearance rates ) , spontaneous cardiac baroreflex sensitivity , heart rate and blood pressure were measured at times @ , @ , @ , @ and @ minutes during OGTT .


Insulin sensitivity was assessed by euglycemic hyperinsulinemic clamp ( M ) and Matsuda index .


PIO increased clamp derived glucose utilisation by @ % ( P < @ ) and there were concurrent reductions in inflammatory status and plasma triglycerides ( P < @ ) .


Fasting norepinephrine kinetic parameters were unaltered .


PIO treatment was associated with lower plasma insulin incursions , greater reduction in diastolic blood pressure and enhanced baroreflex sensitivity during OGTT ( P all < @ ) .


The overall norepinephrine spillover response ( AUC ( @-@ ) ) increased significantly in the PIO group ( group time interaction , P = @ ) , with greatest increment at @ minutes post-glucose ( @ ng/min at baseline versus @ ng/min post treatment , P = @ ) and correlated with percent improvement in M.


PIO enhances the early postprandial SNS response to carbohydrate ingestion .


There is an urgent need for innovative and developmentally appropriate lifestyle interventions to promote healthy lifestyle behaviors and to prevent the early onset of type @ diabetes and cardiovascular disease risk in obese Latino adolescents .


Guided imagery offers promise to reduce stress and promote lifestyle behavior change to reduce disease risk in obese adolescents .


Our objectives were : @ ) To pilot test a new @-wk lifestyle intervention using a randomized trial design in obese Latino adolescents , in order to determine the effects of the mind-body modality of Interactive Guided ImagerySM ( IGI ) , over and above those of a didactic lifestyle education , on insulin resistance , eating and physical activity behaviors , stress and stress biomarkers ; and @ ) To explore the role of intervention-related changes in stress and stress biomarkers on changes in metabolic outcomes , particularly insulin resistance .


Obese ( BMI > @th percentile ) , Latino adolescents ( n = @ , age @-@ ) were randomized to receive either @ weekly sessions of a lifestyle education plus guided imagery program ( GI ) , or lifestyle education plus a digital storytelling computer program ( DS ) .


Between-group differences in behavioral , biological , and psychological outcomes were assessed using unpaired T-tests and ANCOVA in the @ subjects who completed the intervention .


The GI group demonstrated significant reductions in leisure sedentary behavior ( p < @ ) and increases in moderate physical activity ( p < @ ) compared to DS group , and a trend toward reduced caloric intake in GI vs DS ( p = @ ) .


Salivary cortisol was acutely reduced by stress-reduction guided imagery ( p < @ ) .


There were no group differences in adiposity , insulin resistance , perceived stress , or stress biomarkers across the @-week intervention , though decrease in serum cortisol over the course of the intervention was associated with improved insulin sensitivity ( p = @ ) independent of intervention group and other relevant co-variates .


The improvements in physical activity and stress biomarkers following this pilot intervention support the role of guided imagery in promoting healthy lifestyle behavior change and reducing metabolic disease risk in obese Latino adolescent populations .


Future investigations will be needed to determine the full effects of the Imagine HEALTH intervention on insulin resistance , stress , and stress biomarkers .


We examined whether a proactive care smoking cessation intervention designed to overcome barriers to treatment would be especially effective at increasing cessation among African Americans receiving care in the Veterans Health Administration .


We analyzed data from a randomized controlled trial , the Veterans Victory over Tobacco study , involving a population-based electronic registry of current smokers ( @ African Americans , @ whites ) and assessed @-month prolonged smoking abstinence at @ year via a follow-up survey of all current smokers .


We also examined candidate risk adjustors for the race effect on smoking abstinence .


The interaction between patient race and intervention condition ( proactive care vs. usual care ) was not significant .


Overall , African Americans had higher quit rates than Whites ( @ % vs. @ % ; P < @ ) regardless of condition .


African Americans quit at higher rates than Whites .


These findings may be a result of the large number of veterans receiving smoking cessation services and the lack of racial differences in receipt of these services as well as racial differences in smoking history , self-efficacy , and motivation to quit that favor African Americans .


To identify cognitive predictors of geriatric depression treatment outcome .


Older participants completed baseline measures of memory and executive function , health , and baseline and post-treatment Hamilton Depression Scales ( HAM-D ) in a @-week trial comparing psychotherapies ( problem-solving vs. supportive ; N = @ ) .


We examined cognitive predictors to identify treatment responders ( i.e. , HAM-D scores reduced by@ % ) and remitters ( i.e. , post-treatment HAM-D score@ ) .


Empirically derived decision trees identified poorer performance on switching ( i.e. , Trails B ) , with a cut-score of@ predicting psychotherapy responders .


No other cognitive or health variables predicted psychotherapy outcomes in the decision trees .


Psychotherapies that support or improve the executive skill of switching may augment treatment response for older patients exhibiting executive dysfunction in depression .


If replicated , Trails B has potential as a brief cognitive tool for clinical decision-making in geriatric depression .


Childhood obesity has become an alarming worldwide increasing public health problem .


The earlier adiposity rebound occurs , the greater the risk of becoming obese during puberty and adolescence .


It has been speculated about the potential influence of vigorous physical activity on modifying the age of onset of adiposity rebound .


Moreover , studies aimed to evaluate the effectiveness of physical activity interventions programs on reducing adiposity and other cardiovascular risk factors in children younger than @years are scarce .


This paper describes the rationale and methods of a study aimed to test the effectiveness of a two-years multidimensional pre-school intervention on preventing obesity and improving physical fitness during the adiposity rebound period .


Twenty-one schools from the provinces of Cuenca and Ciudad Real , Spain , were randomised to an intervention and a control arm .


In the first academic year , children in third grade of pre-school and first grade of primary school in the intervention group received the physical activity intervention ( MOVI-KIDS ) .


After an academic year schools were crossed over to the alternative arm .


According to the socio-ecological model , the intervention included children , their parents and teachers , and the school environment where MOVI-KIDS was conducted .


MOVI-KIDS consisted of : i ) three-h/week sessions of recreational non-competitive physical activity in after-school time ; ii ) educational materials to parents and teachers about physical activity benefits and sedentary lifestyle risks ; and iii ) modifications in the playground to promote physical activity during recess .


Baseline and post-intervention outcomes are going to be measured in both arms three times , at the beginning and at the end of first academic year , and at the end of the second academic year .


Primary outcomes included body mass index , waist circumference , triceps skinfold thickness , percentage of both body fat and fat-free mass , and blood pressure .


Secondary end points were physical activity , fitness , and carotid intima-media thickness .


This paper reports the design of a randomised cross-over cluster trial aimed at assessing the effectiveness of the multidimensional physical activity intervention ( MOVI-KIDS ) during two years in pre-school children .


The metabolic syndrome is related to the increase in cardiovascular diseases .


Polyunsaturated fatty acids from fish oil help in reducing cardiovascular risk factors and are natural bindings of PPAR@ .


To evaluate the impact of hypocaloric diet associated with microencapsulated fish oil supplementation in women with metabolic syndrome .


We conducted a randomized , single-blind and placebo-controlled clinical trial with adult women who presented metabolic syndrome ( n = @ ) for @ days .


The volunteers were divided into two groups : placebo group ( n = @ ) and microencapsulated fish oil group ( n = @ ) ( @ g/day of microencapsulated fish oil containing @ g/day of eicosapentaenoic acid and decosahexaneoic acid ) .


Anthropometric , body composition , clinical and laboratory parameters were assessed before and after the intervention .


Paired t-test was used for comparisons within groups and Student 's t-test for comparison between groups .


We considered p < @ as significant values .


The comparison between groups revealed a significant reduction of blood glucose , insulinemia and the homeostasis model assessment in the microencapsulated fish oil group after @ days , as opposed to the placebo group .


We also observed reduction of the systolic arterial pressure in the microencapsulated fish oil group .


A hypocaloric diet associated with the consumption of microencapsulated fish oil was effective in reducing blood glucose , insulinemia and insulin resistance in women with MS.


Motivational interviewing ( MI ) has been shown to be an effective strategy for targeting obesity in adolescents , and parental involvement is associated with increased effectiveness .


The aim of this study was to evaluate and compare the role of parental involvement in MI interventions for obese adolescents .


A total of @ Iranian adolescents ( aged @-@ years ) were randomized to receive an MI intervention or an MI intervention with parental involvement ( MI + PI ) or assessments only ( passive control ) .


Data regarding anthropometric , biochemical , psychosocial , and behavioral measures were collected at baseline and @ months later .


A series of intention-to-treat , @-way repeated-measures analysis of covariance were performed to examine group differences in change in outcomes measures over the @-month follow-up period .


Results revealed significant effects on most of the outcome parameters for MI + PI ( eg , mean SD BMI z score : @ @ ) compared with the passive control group ( @ @ ; post hoc test , P = @ ) , as well as an additional superiority of MI + PI compared with MI only ( @ @ ; post hoc test , P = @ ) .


This pattern was also shown for most of the anthropometric , biochemical , psychometric , and behavioral outcome variables .


MI with parental involvement is an effective strategy in changing obesity-related outcomes and has additional effects beyond MI with adolescents only .


These findings might be important when administering MI interventions in school settings .


Central venous catheters play an important role in patient care .


Real-time ultrasound-guided subclavian central venous ( SCV ) cannulation may reduce the incidence of complications and the time between skin penetration and the aspiration of venous blood into the syringe .


Ultrasonic diagnosis of catheter misplacement and pneumothorax related to central venous catheterization is rapid and accurate .


It is unclear , however , whether ultrasound real-time guidance and examination can reduce procedure times and complication rates when compared with landmark guidance and radiographic examination for SCV catheterization .


The Subclavian Central Venous Catheters Guidance and Examination by UltraSound ( SUBGEUS ) study is an investigator-initiated single center , randomized , controlled two-arm trial .


Three hundred patients undergoing SCV catheter placement will be randomized to ultrasound real-time guidance and examination or landmark guidance and radiographic examination .


The primary outcome is the time between the beginning of the procedure and control of the catheter .


Secondary outcomes include the times required for the six components of the total procedure , the occurrence of complications ( pneumothorax , hemothorax , or misplacement ) , failure of the technique and occurrence of central venous catheter infections .


The SUBGEUS trial is the first randomized controlled study to investigate whether ultrasound real-time guidance and examination for SCV catheter placement reduces all procedure times and the rate of complications .


Disturbance in sleep quality is a symptom of Major Depressive Disorder ( MDD ) and Bipolar Disorder ( BD ) and thus improving quality of sleep is an important aspect of successful treatment .


Here , a prospective , double-blind , randomized , placebo-controlled study examined the effect of olanzapine ( an atypical antipsychotic ) augmentation therapy on sleep architecture , specifically slow wave sleep ( SWS ) , in the treatment of depression .


The effect of olanzapine augmentation therapy on other features of sleep ( e.g. , sleep continuity ) and depression ( e.g. , illness severity and cognitive function ) were also determined .


Patients currently experiencing a major depressive episode and who were on a stable medication were included .


Sleep architecture was measured by overnight ambulatory polysomnography .


Illness severity was determined using the Montgomery-Asberg Depression Rating Scale ( MADRS ) .


Cognitive function was examined using Cambridge Neuropsychological Test Automated Battery ( CANTAB ) : Spatial Working Memory ( SWM ) , Spatial Span ( SSP ) , and Reaction Time ( RTI ) tasks .


Polysomnographs , clinical measures and cognitive tests were administered at baseline , after @-@ days of treatment and after @-@ days of treatment .


Twenty-five patients participated in the study ( N = @ , N = @ for placebo and olanzapine treated groups respectively ) .


The primary objective of the study was to assess the objective ( polysomnographic ) changes in sleep quality , defined as changes in SWS , following olanzapine treatment for depression .


Latency to but not duration of SWS was found to significantly differ between olanzapine - and placebo-treated participants ( Hedge 's g : @ , @ respectively ) .


A significant improvement in olanzapine-treated participants over placebo-treated participants was observed in secondary outcome measures , including sleep efficiency , total sleep time , and sleep latency .


Secondary objectives assessed the subjective changes in sleep quality parameters and correlated them with measures of illness severity and changes in cognition .


MADRS scores were significantly improved in olanzapine-treated participants over time but not more than placebo treatment .


There was no significant difference between olanzapine - and placebo-treated participants in SWM , SSP or RTI tasks .


Olanzapine augmentation treatment generally did not improve SWS but did improve sleep continuity and depression .


Olanzapine may be one of few medications that improve sleep continuity , thus directly targeting symptoms of depression .


To demonstrate bioequivalence of linagliptin/metformin fixed-dose combination ( FDC ) tablets and the corresponding combination of individual tablets taken together , i.e. , free-pill ( FP ) treatment .


Three dosing combinations were evaluated in three separate randomized studies : linagliptin @ mg with @ mg , @ mg , or @,@ mg metformin .


These studies used a prospective , open-label , randomized , two-way crossover design to evaluate bioequivalence in healthy volunteers ( n = @ ) .


After an overnight fast , participants received an FDC tablet once , and on a separate visit received the corresponding FP treatment .


The two possible treatment sequences ( FDC/FP and FP/FDC ) were randomly allocated to the participants .


A washout period of @ days separated the two study treatments .


The primary endpoints were maximum plasma concentration ( Cmax ) of linagliptin and metformin , area under the plasma concentration time curve from @ to @ hours ( AUC@-@ ) for linagliptin , and from @ to infinity ( AUC@-inf ) for metformin .


The @ % confidence intervals of the adjusted geometric mean ratios of Cmax and AUC ( calculated as FDC / FP ) were within the bioequivalence acceptance limits of @ - @ % .


The number of participants reporting at least one adverse event following FDC treatments was comparable to , or less than , that following FP treatments .


Evaluation of vital signs and clinical laboratory tests revealed no safety issues .


FDC tablets of linagliptin and metformin are bioequivalent to individual tablets of respective dose strengths taken together .


Both treatments were well tolerated .


There are few evidence-based mobile health solutions for treating adolescent obesity .


The primary aim of this parallel non-inferiority trial is to assess the effectiveness of an experimental smartphone application in reducing obesity at @ months , compared to the Temple Street W@GO Healthy Lifestyles intervention .


The primary outcome measure is change in body mass index standardised deviation score at @ months .


The secondary aim is to compare the effect of treatment on secondary outcomes , including waist circumference , insulin sensitivity , quality of life , physical activity and psychosocial health .


Adolescents with a body mass index at or above the @th percentile ( @ to @ years ) will be recruited from the Obesity clinic at Temple Street Children 's University Hospital in Dublin , Ireland .


W@GO is a family-based lifestyle change intervention delivered in two phases over @ months .


In the current study , participants will be randomised for phase two of treatment to either usual care or care delivered via smartphone application .


One hundred and thirty-four participants will be randomised between the two study arms .


An intention-to-treat analysis will be used to compare treatment differences between the groups at @ months .


The results of this study will be disseminated via open access publication and will provide important information for clinicians , patients and policy makers regarding the use of mobile health interventions in the management of adolescent obesity .


Degradation of the somatosensory system has been implicated in postural instability and increased falls risk for older people and Parkinson 's disease ( PD ) patients .


Here we demonstrate that textured insoles provide a passive intervention that is an inexpensive and accessible means to enhance the somatosensory input from the plantar surface of the feet .


@ healthy older adults ( controls ) and @ participants with PD were recruited for the study .


We evaluated effects of manipulating somatosensory information from the plantar surface of the feet using textured insoles .


Participants performed standing tests , on two different surfaces ( firm and foam ) , under three footwear conditions : @ ) barefoot ; @ ) smooth insoles ; and @ ) textured insoles .


Standing balance was evaluated using a force plate yielding data on the range of anterior-posterior and medial-lateral sway , as well as standard deviations for anterior-posterior and medial-lateral sway .


On the firm surface with eyes open both the smooth and textured insoles reduced medial-lateral sway in the PD group to a similar level as the controls .


Only the textured insole decreased medial-lateral sway and medial-lateral sway standard deviation in the PD group on both surfaces , with and without visual input .


Greatest benefits were observed in the PD group while wearing the textured insoles , and when standing on the foam surface with eyes closed .


Data suggested that textured insoles may provide a low-cost means of improving postural stability in high falls-risk groups , such as people with PD .


A randomized controlled trial was conducted to evaluate the efficacy of impedance control of a radiofrequency interstitial thermal ablation system ( RITA ) used to treat hepatocellular carcinoma ( HCC ) .


Fifteen patients with hypervascular HCCs < @ mm in diameter were randomly treated with radiofrequency ablation ( RFA ) using conventional temperature control ( group A ) or impedance control methods ( group B ) .


RITA needle electrodes were used in all cases .


We compared ablation time , extent of lesion ablation , and energy use between the two groups .


The median long and short diameters of the axial cross sections of radiofrequency-induced necrotic areas visualized by CT were @ mm ( range , @-@ ) and @ mm ( @-@ ) in group A and @ mm ( @-@ ) and @ mm ( @-@ ) in group B , respectively .


The short diameter of group B patients was significantly greater than that of group A patients ( p = @ ) .


The median ablation time was @ min in group A and @ min in group B , thus significantly shorter in group B ( p = @ ) .


The energy requirement did not differ significantly between the groups .


Impedance control of the RITA system resulted in an increased size of the ablation zone and a decreased ablation time .


To investigate clinical outcome of laparoendoscopic single-site compared with traditional three-port in treatment of ovarian cystectomy .


From February @ to June @ , @ patients with ovarian cyst were randomized to the single-site group ( n = @ ) or the three-port group ( n = @ ) in Peking Union Medical College Hospital .


The outcome of laparoscopic single-site and three-port ovarian cystectomy were evaluated .


Operation time , blood loss , surgical complications , postoperative pain score , postoperative analgesic requirements , length of hospital stay , cosmetic satisfaction score , postoperative recovery and total cost were compared between both groups .


No difference was found in blood loss , length of hospital stay , complications and total cost between the two groups ( P > @ ) .


Operation time was ( @ @ ) minute in three-port group and ( @ @ ) minute in single-site group .


Visual analogue pain score was @ @ in three-port group and @ @ in single-site group , cosmetic satisfaction score was @ @ in three-port group and @ @ in single-site group .


Those clinical parameter reached statistical difference ( all P < @ ) .


Laparoendoscopic single site surgery approach is feasible and safe to treat benign ovarian cyst disease .


And it offers decreased pain and offer improved cosmesis .


Although colon cancer ( CC ) with microsatellite instability ( MSI ) has a more favorable prognosis than microsatellite stable ( MSS ) CC , the impact varies according to clinicopathological parameters .


We studied how MSI status affects prognosis in a trial-based cohort of stage II and III CC patients treated with @-fluorouracil ( @-FU ) / leucovorin or FOLFIRI .


Tissue specimens of @ patients were tested for @ different loci and were classified as MSI-high ( MSI-H ) when three or more loci were unstable and MSS otherwise .


Study end points were overall survival ( OS ) and relapse-free survival ( RFS ) .


In stage II , RFS and OS were better for patients with MSI-H than with MSS CC -LSB- hazard ratio ( HR ) @ , @ % CI @-@ @ , P = @ and @ , @ % CI @-@ @ , P = @ ) .


In stage III , RFS was slightly better for patients with MSI-H CC ( HR @ , @ % CI @-@ @ , P = @ ) , but the difference was not statistically significant for OS ( HR @ , @ % CI @-@ @ , P = @ ) .


Outcomes for patients with MSI-H CC were not different between the two treatment arms .


RFS was better for patients with MSI-H than with MSS CC in the right and left colon , whereas for OS this was significant only in the right colon .


For patients with KRAS - and BRAF-mutated CC , but not for double wild-type patients , RFS and OS were significantly better when the tumors were also MSI-H .


An interaction test was statistically significant for KRAS and MSI status ( P = @ ) , but not for BRAF status ( P = @ ) .


Our results confirm that for patients with stage II CC but less so for those with stage III MSI-H is strongly prognostic for RFS and OS .


In the presence of @-FU treatment , stage II patients with MSI-H tumors maintain their survival advantage in comparison with MSS patients and adding irinotecan has no added benefit .


CLINICALTRIALS.GOV IDENTIFIER : NCT@ .


To evaluate the effectiveness of an eHealth intervention on recovery and return to work , after gynaecological surgery .


Randomised multicentre trial that ran from March @ until September @ .


Secondary care in seven general and university hospitals in The Netherlands .


A cohort of @ women ( aged @-@ years ) who had a hysterectomy and/or laparoscopic adnexal surgery for a benign indication .


The women were randomly assigned to the intervention group ( n = @ ) or the control group ( n = @ ) .


The intervention group received an eHealth programme that provided personalised tailor-made pre - and postoperative instructions on the resumption of daily activities , including work , and tools to improve self-empowerment and to identify recovery problems .


The control group was provided with access to a control website .


The primary outcome was the duration of sick leave until a full sustainable return to work .


Secondary outcome measures were quality of life , general recovery , and pain intensity .


In intention-to-treat analysis the eHealth intervention was effective on time to return to work ( hazard ratio @ ; @ % confidence interval @-@ @ ; P = @ ) .


The median duration of sick leave until a full sustainable return to work was @ days ( interquartile range @-@ days ) in the intervention group and @ days ( interquartile range @-@ days ) in the control group .


After @ weeks pain intensity was lower ( visual analogue scale , cumulative odds ratio @ ; @ % confidence interval @-@ @ ; P = @ ) and quality of life was higher ( Rand-@ health survey , between-group difference @ , @ % confidence interval @-@ ; P = @ ) in the intervention group , compared with the control group .


The use of the eHealth intervention by women after gynaecological surgery results in a faster return to work , with a higher quality of life and less pain .


To evaluate the safety and efficacy of abiraterone acetate and prednisolone in Korean and Taiwanese patients with metastatic castration-resistant prostate cancer not responding to docetaxel-based chemotherapy .


In this single-arm study , @ metastatic castration-resistant prostate cancer patients who failed docetaxel-based chemotherapy were treated with abiraterone ( @ mg , once daily ) and prednisolone ( @ mg , twice daily ) .


Patients achieving a prostate-specific antigen decline @ % were considered as responding .


A total of @ patients ( @ % ) achieved prostate-specific antigen response ( @ % confidence interval @-@ ) .


The median time to prostate-specific antigen progression was @ months ( @ % confidence interval @-@ @ ) ; the median overall survival was @ months .


Two ( @ % ) of @ patients with measurable disease achieved partial response .


The median testosterone concentration was in the castration range ( @ nmol/L ) throughout the treatment period .


Median dehydroepiandrosterone sulfate decreased from @ mol/L ( baseline ) to @ mol/L ( cycle @ ) .


The most common adverse event was bone pain ( @ % ) ; grade @/@ adverse event of special interest were hypokalemia ( @ % ) , fluid retention and liver function abnormalities ( @ % each ) , hypertension ( @ % ) , and cardiac disorders ( @ % ) .


A combination of abiraterone acetate and prednisolone appears to be a favorable second-line treatment in Taiwanese and Korean patients with advanced metastatic castration-resistant prostate cancer after failed docetaxel-based chemotherapy .


Predictors of response to treatment with peginterferon plus ribavirin are well established .


In these post-hoc analyses of the REALIZE study , we sought to identify predictors of response for telaprevir-based triple therapy .


Patients from the REALIZE study with baseline data for all predictors evaluated ( including baseline disease characteristics and demographics , prior treatment response and baseline laboratory assessments ) were included in the post-hoc analyses ( n = @ ) .


Univariate and multivariate analyses were used to evaluate factors predicting treatment outcomes .


Sustained viral response ( SVR ) rates were @ % in prior relapsers , @ % in prior partial responders and @ % in prior null-responders .


In the final multivariate analysis , baseline factors predicting SVR were prior response to treatment -LSB- Odds ratio ( OR ) = @ ; @ % confidence interval ( CI ) , @-@ @ -RSB- , low-density lipoprotein ( LDL ) ( @ mmol/L ) ( OR = @ ; @ % CI , @-@ @ ) , HCV genotype ( OR = @ ; @ % CI , @-@ @ ) , and maximum alanine amino transferase and aspartate amino transferase ( OR = @ ; @ % CI , @-@ @ ) .


Prior response to peginterferon plus ribavirin treatment and LDL levels are the main independent predictive markers of response with telaprevir-based triple therapy .


To compare primary intra-ocular lens ( IOL ) implantation with use of press-on spherical lens for aphakia correction following unilateral infantile cataract removal .


Sixty infants with a unilateral cataract underwent cataract surgery and were randomly assigned to the IOL ( A group ) or no IOL group ( B group ) .


Residual refractive error was corrected with spectacles in the A group and a press-on spherical lens was used to treat aphakia in the B group .


Grating visual acuity ( VA ) was measured and patients were followed for up to @ year .


LogMAR VA in the operated eyes of both groups was significantly better @ year than @ month after surgery .


Mean logMAR VA difference between @ year and @ month after surgery was higher in the A group ( @ @ ) than in the B group ( @ @ , p < @ ) .


Serious inflammation occurred significantly more often in the A group than in the B group ( p = @ ) .


Visual axis opacity occurred more often in the A group than in the B group ( pupillary membrane : A : six eyes , @ % , B : none , p = @ ; lens reproliferation : A : @ eyes , @ % , B : two eyes , @ % , p = @ ) .


Glaucoma occurred equally in both groups ( p = @ ) .


No other complications occurred .


Primary IOL implantation appears to be a relatively safe , effective optical correction strategy following unilateral cataract extraction in this age group .


Patients for whom an IOL is not suitable can be treated with a press-on spherical lens for optical correction .


Labor epidural analgesia is highly effective , but can be limited by slow onset and incomplete blockade .


The administration of warmed , compared to room temperature , bupivacaine has resulted in more rapid onset epidural anesthesia .


We hypothesized that the administration of bupivacaine with fentanyl at @C versus @C would result in improved initial and ongoing labor epidural analgesia .


In this prospective , randomized , doubled blinded study , @ nulliparous , laboring women were randomized to receive epidural bupivacaine @ % with fentanyl @ g/mL ( @ mL initial and @ mL hourly boluses ) at either @C or @C .


Pain verbal rating scores ( VRS ) , sensory level , oral temperature , and side effects were assessed after epidural loading ( time @ ) , at @ , @ , @ , @ , @ , @ min , and at hourly intervals .


The primary outcome was the time to achieve initial satisfactory analgesia ( VRS @ ) .


Secondary outcomes included ongoing quality of sensory blockade , body temperature and shivering .


There were no differences between groups in patient demographics , initial pain scores , cervical dilatation , body temperature or mode of delivery .


Epidural bupivacaine at @C resulted in shorter mean ( SD ) analgesic onset time ( @ vs. @ min , P = @ ) and improved analgesia for the first @ min after initial bolus ( P = @-@ @ ) .


Although patient temperature increased during the study ( P < @ ) , there were no differences between the groups ( P = @ ) .


Six ( @ % ) and @ ( @ % ) patients experienced shivering in the @C and @C groups , respectively ( P = @ ) .


The administration of epidural @ % bupivacaine with fentanyl @g/mL at @C versus @C resulted in more rapid onset and improved labor analgesia for the first @ min .


There was no evidence of improved ongoing labor analgesia or differences in side effects between groups .


To compare the outcomes of sub-Bowman keratomileusis ( @-m flap ) and laser in situ keratomileusis ( LASIK ) ( @-m flap ) using @-kHz femtosecond laser .


Randomized , double-masked , contralateral clinical trial .


One hundred patients ( @ eyes ) with myopia or myopic astigmatism were included .


Postoperative examinations were performed at week @ and months @ , @ , @ , and @ .


Main outcome measures included postoperative uncorrected ( UCVA ) and best-corrected distance visual acuity ( BCVA ) ; manifest refraction spherical equivalent ; efficacy and safety indices ; corneal thickness ; and complications .


The mean age of patients was @ @ years .


Overall , the preoperative UCVA , BCVA , and manifest refraction spherical equivalent were @ @ , -@ @ , and -@ @ diopters , respectively .


No significant difference was observed in preoperative ( P @ ) or intraoperative parameters ( P @ ) between both groups , except residual stromal thickness ( P < @ ) .


The UCVA , manifest refraction spherical equivalent , and central corneal thickness stabilized by @ week , while the thinnest corneal thickness stabilized by @ months postoperatively .


There was no significant difference between both groups for any parameter during all follow-up visits ( P @ ) except the @-month safety index , which was better in the sub-Bowman keratomileusis group ( P = @ ) .


Soft opaque bubble layer was noted intraoperatively in @ cases ( @ , @-m group ; @ , @-m group ; P = @ ) .


No postoperative complications were observed .


Our study did not find any differences in the visual and refractive outcomes between femtosecond-assisted sub-Bowman keratomileusis and LASIK .


Both surgeries resulted in quick visual recovery as early as @ week postoperatively .


Developmental delays and disabilities are common in children .


Research has indicated that intervention during the early years of a child 's life has a positive effect on cognitive development , social skills and behavior , and subsequent school performance .


To determine whether a computerized clinical decision support system is an effective approach to improve standardized developmental surveillance and screening ( DSS ) within primary care practices .


In this cluster randomized clinical trial performed in @ pediatric clinics from June @ , @ , through December @ , @ , children younger than @ months seen for primary care were studied .


We compared surveillance and screening practices after adding a DSS module to an existing computer decision support system .


The rates at which children were screened for developmental delay .


Medical records were reviewed for @ children ( @ each in the intervention and control groups ) to compare rates of developmental screening at the @ - , @ - , or @-month well-child care visits .


The DSS module led to a significant increase in the percentage of patients screened with a standardized screening tool ( @ % vs @ % , P < @ ) .


An additional @ records ( @ each in the intervention and control groups ) were reviewed to examine surveillance rates at visits outside the screening windows .


The DSS module led to a significant increase in the percentage of patients whose parents were assessed for concerns about their child 's development ( @ % vs @ % , P = @ ) .


Using a computerized clinical decision support system to automate the screening of children for developmental delay significantly increased the numbers of children screened at @ , @ , and @ months of age .


It also significantly improved surveillance at other visits .


Moreover , it increased the number of children who ultimately were diagnosed as having developmental delay and who were referred for timely services at an earlier age .


The HVTN @/Phambili study , which assessed the efficacy of the Merck Ad@ gag/pol/nef subtype B HIV-@ preventive vaccine in South Africa , was stopped when futility criteria in the Step study ( assessing the same vaccine in the Americas , Caribbean , and Australia ) were met .


Here we report long-term follow-up data .


HVTN @/Phambili was a double-blind , placebo-controlled , randomised trial that recruited HIV-@ uninfected , sexually active adults aged @-@ years from five sites in South Africa .


Eligible participants were randomly assigned ( @:@ ) by computer-generated random numbers to either vaccine or placebo , stratified by site and sex .


Cox proportional hazards models were used to estimate HIV-@ infection in the modified intention-to-treat cohort , all of whom were unmasked early in follow-up .


The trial is registered with ClinicalTrials.gov , number NCT@ and the South African National Health Research Database , number DOH-@-@-@ .


Between Jan @ , @ , and Sept @ , @ , @ participants ( @ % ) of a planned @ were randomly assigned ( @ to vaccine , @ to placebo ) ; @ ( @ % ) received only one injection , @ ( @ % ) received only two injections , and @ ( @ % ) received three injections .


At a median follow-up of @ months ( IQR @-@ ) , @ vaccine recipients ( @ % ) had HIV-@ infection compared with @ placebo recipients ( @ % ; adjusted HR @ , @ % CI @-@ ; p = @ ) .


Risk for HIV-@ infection did not differ according to the number of vaccinations received , sex , circumcision , or adenovirus type @ ( Ad@ ) serostatus .


Differences in risk behaviour at baseline or during the study , or annualised dropout rate ( @ % -LSB- @ % CI @-@ -RSB- for vaccine recipients vs @ % -LSB- @-@ -RSB- for placebo recipients ; p = @ ) are unlikely explanations for the increased rate of HIV-@ infections seen in vaccine recipients .


The increased risk of HIV-@ acquisition in vaccine recipients , irrespective of number of doses received , warrants further investigation to understand the biological mechanism .


We caution against further use of the Ad@ vector for HIV vaccines .


Patients entering treatment for alcohol problems do not have uniform treatment goals , and a pretreatment drinking goal has a significant impact on treatment outcome .


The objective of this study was to understand better how an array of individual characteristics , including factors that affect treatment , are related to treatment goals before beginning alcohol treatment in the COMBINE ( Combining Medications and Behavioral Interventions ) Study .


Participants were alcohol-dependent individuals ( N = @,@ ; @ women ) recruited at @ outpatient academic alcoholism-treatment clinics across the United States to participate in a randomized , double-blind , placebo-controlled trial that combined behavioral intervention with acamprosate and/or naltrexone .


Treatment goal was coded as controlled drinking , conditional abstinence , or total abstinence .


Multinomial logistic regressions assessed whether there were significant relationships between predictor variables and pretreatment goal selection .


Lower levels of alcohol-related consequences , lower readiness to change , higher family income , more daily drinkers in social network , and lack of prior treatment or Alcoholics Anonymous engagement predicted choice of a controlled drinking goal over a total abstinence goal .


Fewer alcohol-related consequences , lower readiness to change , and more daily drinkers in-network predicted choice of a conditional abstinence goal over a total abstinence goal .


Higher levels of functioning , lower levels of consequences , no prior involvement in treatment and Alcoholics Anonymous , and a more drinking-saturated social environment are associated with the choice of a non-abstinence goal .


Compact and short pre-travel immunization schedules , which include several vaccinations in a single visit , are desirable for many travelers .


However , concomitant vaccination could potentially compromise immunogenicity and/or safety of the individual vaccines and , therefore , possible vaccine interferences should be carefully assessed .


This article discusses the immunogenicity and safety of travel vaccines for typhoid fever ( TF ) and yellow fever ( YF ) , when administered with or without a quadrivalent meningococcal glycoconjugate ACWY-CRM vaccine ( MenACWY-CRM ) .


Healthy adults ( @-@years ) were randomized to one of three vaccine regimens : TF+YF+M enACWY-CRM ( group I ; n = @ ) , TF+YF ( group II ; n = @ ) , or MenACWY-CRM ( group III ; n = @ ) .


Immunogenicity at baseline and @weeks post-vaccination ( day @ ) was assessed by serum bactericidal assay using human complement ( hSBA ) , enzyme-linked immunosorbent assay ( ELISA ) , or a neutralization test .


Adverse events ( AEs ) and serious adverse events ( SAEs ) were collected throughout the study period .


Non-inferiority of post-vaccination geometric mean concentrations ( GMCs ) and geometric mean titers ( GMTs ) was established for TF and YF vaccines , respectively , when given concomitantly with MenACWY-CRM vaccine versus when given alone .


The percentages of subjects with seroprotective neutralizing titers against YF on day @ were similar in groups I and II .


The antibody responses to meningococcal serogroups A , C , W-@ , and Y were within the same range when MenACWY-CRM was given separately or together with TF and YF vaccines .


The percentage of subjects reporting AEs was the same for TF and YF vaccines with or without MenACWY-CRM vaccine .


There were no reports of SAEs or AEs leading to study withdrawals .