The primary endpoint was complete abstinence after @ weeks of administration .


The study was performed at @ medical institutions between @ and @ .


The acamprosate group demonstrated significantly superior efficacy versus the placebo group on the primary endpoint : the proportion maintaining complete abstinence in the acamprosate group was @ % ( @/@ subjects ) , compared with @ % ( @/@ subjects ) in the placebo group ( P = @ ) .


The difference in complete abstinence rates between the @ groups was @ % ( @ % CI , @ % -@ % ) .


Acamprosate is superior to placebo in maintaining abstinence in Japanese patients with alcohol dependence .


These findings concur with @ randomized , blinded , placebo-controlled clinical trials conducted in Europe .


This study was designed to reflect clinical practice in Japan and is therefore a meaningful addition to the available evidence in this field .


To investigate the use of neuromuscular electrical stimulation ( NMES ) during acute recovery between @ bouts of maximal aerobic exercise .


On @ separate days , @ trained male cyclists ( @ @ y , @ @ kg , power output at maximal aerobic power -LSB- pVo@max -RSB- @ @ W ) performed a @-min maximal cycling bout at @ % PVo@max before a @-min randomly assigned recovery intervention of passive ( PAS : resting ) , active ( ACT : @ % PVo@max ) , or NMES ( @ Hz , @ pulses at @ s ) .


Immediately afterward , a cycle bout at @ % PVo@max to exhaustion ( TLIM ) was performed .


Heart rate ( HR ) and blood lactate ( BLa ) were recorded at designated time points .


Data were analyzed using repeated-measures ANOVA with a Tukey honestly significantly different post hoc test .


Statistical significance threshold was P < @ .


The TLIM was significantly shorter for NMES than for ACT ( @ @ s vs @ @ s : P = @ ) but not PAS recovery ( @ @ s vs @ @ s : P = @ ) .


The TLIM was not significantly different between ACT and PAS ( @ @ s vs @ @ s : P = @ ) .


The decline in BLa was significantly greater during ACT than NMES and PAS recovery ( P < @ ) , with no difference between NMES and PAS .


In addition , HR was significantly higher during ACT than NMES and PAS recovery ( P < @ ) , with no difference between NMES and PAS .


NMES was less effective than ACT and comparable to PAS recovery when used between @ bouts of maximal aerobic exercise in trained male cyclists .


The National Institute for Health and Care Excellence ( NICE ) guidelines for attention deficit/hyperactivity disorder ( ADHD ) state that young people need to have access to the best evidence-based care to improve outcome .


The current ` gold standard ' ADHD diagnostic assessment combines clinical observation with subjective parent , teacher and self-reports .


In routine practice , reports from multiple informants may be unavailable or contradictory , leading to diagnostic uncertainty and delay .


The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes .


This trial investigates whether providing clinicians with an objective report of levels of attention , impulsivity and activity can lead to an earlier , and more accurate , clinical diagnosis and improved patient outcome .


This multisite randomised controlled trial will recruit young people ( aged @-@ years old ) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services ( CAMHS ) and Community Paediatric clinics across England .


Routine clinical assessment will be augmented by the QbTest , incorporating a continuous performance test ( CPT ) and infrared motion tracking of activity .


The participant will be randomised into one of two study arms : QbOpen ( clinician has immediate access to a QbTest report ) : QbBlind ( report is withheld until the study end ) .


Primary outcomes are time to diagnosis and diagnostic accuracy .


Secondary outcomes include clinician 's diagnostic confidence and routine clinical outcome measures .


Cost-effective analysis will be conducted , alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice .


Studies have shown that repeated post-prandial hyperglycemia may play an important role in the development of atherosclerosis by suppressing endothelial function .


- Glucosidase inhibitors ( - GIs ) , which reduce post-prandial hyperglycemia without stimulating insulin secretion , significantly reduce the risk of coronary artery disease ( CAD ) , whereas glinides , which improve post-prandial hyperglycemia through post-prandial insulin secretion , do not appear to affect CAD .


A total of @ diabetic patients with CAD were randomly divided into @ groups : those treated with miglitol ( M-group ; n = @ ) and those treated with nateglinide ( N-group ; n = @ ) .


After @ months ' treatment , although hemoglobin A@c and @,@-anhydroglucitol were significantly improved in both groups , only the M-group had significant reductions in insulin resistance index and triglyceride/high-density lipoprotein cholesterol ( TG/HDL-C ; a beneficial index for assessing the presence of small dense low-density lipoprotein , and a marker of atherogenic dyslipidemia ) .


Furthermore , only the M-group had improvement in percentage flow-mediated dilatation ( % FMD ) and reactive oxygen metabolites .


In the M-group , multiple regression analysis showed that improvement in TG/HDL-C , in addition to @,@-anhydroglucitol , was an independent predictor of improvement in % FMD .


The ameliorating effect of - GI on post-prandial hyperglycemia without stimulating insulin secretion may improve atherogenic dyslipidemia by reducing insulin resistance .


These effects are associated with its beneficial impact on oxidative stress , consequently leading to an improvement in endothelial dysfunction .


To evaluate three coronary artery calcification ( CAC ) scoring methods to assess risk of coronary heart disease ( CHD ) death and all-cause mortality in National Lung Screening Trial ( NLST ) participants across levels of CAC scores .


The NLST was approved by the institutional review board at each participating institution , and informed consent was obtained from all participants .


Image review was HIPAA compliant .


Five cardiothoracic radiologists evaluated @ low-dose computed tomographic ( CT ) scans from three groups : @ CHD deaths , @ deaths not from CHD , and @ participants who were alive at conclusion of the trial .


Radiologists used three scoring methods : overall visual assessment , segmented vessel-specific scoring , and Agatston scoring .


Weighted Cox proportional hazards models were fit to evaluate the association between scoring methods and outcomes .


In multivariate analysis of time to CHD death , Agatston scores of @-@ , @-@ , and greater than @ ( reference category @ ) were associated with hazard ratios of @ ( @ % confidence interval : @ , @ ) , @ ( @ % confidence interval : @ , @ ) , and @ ( @ % confidence interval : @ , @ ) , respectively ; hazard ratios for summed segmented vessel-specific scores of @-@ , @-@ , and @-@ ( reference category @ ) were @ ( @ % confidence interval : @ , @ ) , @ ( @ % confidence interval : @ , @ ) , and @ ( @ % confidence interval : @ , @ ) , respectively ; and hazard ratios for overall visual assessment of mild , moderate , or heavy ( reference category none ) were @ ( @ % confidence interval : @ , @ ) , @ ( @ % confidence interval : @ , @ ) , and @ ( @ % confidence interval : @ , @ ) , respectively .


By using low-dose CT performed for lung cancer screening in older , heavy smokers , a simple visual assessment of CAC can be generated for risk assessment of CHD death and all-cause mortality , which is comparable to Agatston scoring and strongly associated with outcome .


Postoperative cognitive decline is common after cardiac surgery , but it is often unrecognized at the time of hospital discharge .


However , it has a great impact on patient 's quality of life .


Cerebral oximetry with the INVOS ( IN Vivo Optical Spectroscopy ) system provides the possibility of non-invasive , continuous measurement of regional cerebral oxygen saturation ( rSO@ ) , which can improve patients ' outcome .


The aim of this study was to examine whether cerebral oximetry can decrease the incidence of cognitive decline after coronary artery bypass grafting .


We have performed a prospective , randomized study with @ patients enrolled .


Patients were divided into INVOS interventional group and CONTROL group without monitoring of cerebral oximetry .


A standardized interventional protocol was performed in the INVOS group to maintain rSO@ above @ % of the patient 's baseline value or above @ % of the absolute value .


Cognitive evaluation was performed in all patients before and @ days after surgery .


Logistic regression was used to reveal predictors of cognitive decline .


The incidence of cognitive decline @ days after surgery was significantly lower ( P = @ ) in the INVOS interventional group ( @ % ) than in the CONTROL group ( @ % ) .


Intraoperative use of INVOS monitoring was associated with lower incidence of cognitive decline ( odds ratio @ ) .


In addition , predictors of cognitive decline revealed by multivariate logistic regression were older age , higher EuroSCORE and SAPS II ( Simplified Acute Physiology Score ) values , lower educational level and persistence of preoperative atrial fibrillation .


Patients with prolonged rSO@ desaturation , defined as rSO@ area under the curve ( AUC ) of more than @ min % for desaturation below @ % of baseline or AUC of more than @ min % for desaturation below @ % absolute value , had an increased risk of cognitive decline .


Postoperative cognitive outcome was significantly better in patients with intraoperative cerebral oximetry monitoring .


Prolonged rSO@ desaturation is a predictor of cognitive decline and has to be avoided .


Clozapine is considered to be particularly effective in the treatment of dually diagnosed ( DD ) patients with psychosis and substance use disorders .


However , its use is restricted by potentially severe side effects .


The aim of the present pilot study was to compare the effects of clozapine with the newer second generation antipsychotic ( SGA ) ziprasidone in DD-patients .


Thirty ( n = @ ) patients with schizophrenia and cannabis abuse/dependence were randomized to ziprasidone or clozapine and were followed up for up to @ months .


Cannabis use was reduced in both groups during follow-up .


Clozapine treatment was associated with less positive symptoms of schizophrenia , more side effects and poorer compliance with treatment .


Results from this small pilot RCT suggest beneficial effects of both clozapine and ziprasidone in the treatment of cannabis use disorders in psychotic patients .


Larger-scale RCTs are needed in order to assess advantages and disadvantages of the different SGAs in dually diagnosed populations .


This study was part of a Phase @ program treating crow 's feet lines ( CFL ) with onabotulinumtoxinA .


To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL .


This multicenter , double-blind , placebo-controlled , @-month study randomized subjects with moderate-to-severe CFL ( maximum smile ) to onabotulinumtoxinA ( @ U ; n = @ ) or placebo ( n = @ ) .


Investigators and subjects assessed CFL severity ( maximum smile and rest ) using the @-grade Facial Wrinkle Scale ( FWS ) .


Co-primary end points were investigator - and subject-assessed proportion of subjects achieving a CFL FWS grade of @ ( none ) or @ ( mild ) at maximum smile ( Day @ ) .


Additional efficacy end points , patient-reported outcomes , and safety/adverse events ( AEs ) were evaluated .


All primary and secondary end points were achieved ; statistically significant differences favored onabotulinumtoxinA ( p < @ , all comparisons vs placebo ) .


Co-primary responder rates were @ % compared with @ % for investigator-assessed and @ % compared with @ % for subject-assessed response ( onabotulinumtoxinA group and placebo , respectively ; p < @ ) .


A significantly greater proportion of the onabotulinumtoxinA group than placebo group achieved a @ grade or greater improvement on the FWS ( maximum smile and rest assessed by both the investigator and subject ; all time points ; p < @ ) .


Most AEs were mild or moderate and did not result in discontinuations .


Treatment of moderate-to-severe CFL with onabotulinumtoxinA was effective and well tolerated .


p@ mitogen-activated protein kinase ( MAPK ) mediates cytokine production and amplification of the inflammatory cascade .


Through inhibition of p@ MAPK , losmapimod appears to attenuate the inflammatory response in the vascular wall and thus may help stabilize plaques .


The LATITUDE-TIMI @ trial is a randomized , double-blind , placebo-controlled , parallel-group , multicenter study planned to be conducted in a @-stage design .


Overall , the trial is designed to include @,@ patients hospitalized with non-ST-elevation or ST-elevation myocardial infarction ( MI ) randomized to oral losmapimod ( @ mg twice daily ) versus matching placebo .


Part A consists of a leading cohort ( n = @,@ ) that will provide an initial assessment of safety and exploratory efficacy before progressing to part B. Part B ( n = ~ @,@ ) of the study is event driven and will provide the primary assessment of efficacy .


An independent safety review will be conducted after @,@ patients in part B@ to determine whether a more focused schedule of clinic visits and laboratory assessments can be implemented ( part B@ ) .


All patients are to be treated with study drug until week @ and followed up until week @ .


The primary end point is the composite of cardiovascular death , MI , or severe recurrent ischemia requiring urgent coronary revascularization .


The key secondary end point is the composite of cardiovascular death or MI .


The trial is designed to provide @ % power for the primary end point .


The LATITUDE-TIMI @ trial will determine the efficacy and safety of short-term p@ MAPK inhibition with losmapimod in acute MI .


The trial design adopts a stepwise approach to decision making and collection of data .


Hyangaa-Pyeongwi san is the most well known description in Traditional Chinese Medicine for treating functional gastrointestinal disorders .


Functional dyspepsia ( FD ) is a main concern of intimidating quality of life ( QoL ) in recent days .


Although many medicines have been developed to improve FD symptoms as well as QoL , there are no potential drugs and treatments for FD .


The aim of this study is to investigate the effects of Hyangaa-Pyeongwi san ( HPS ) on QoL of patients with FD .


This study was designed as a randomized , double blinded , placebo controlled , and parallel group trial .


Participants received either placebo or HPS ( @ g of HPS at once , three times daily ) for @-weeks , and the efficacy evaluations were performed by assessing the Nepean Dyspepsia Index ( NDI ) and functional dyspepsia-quality of life ( FD-QoL ) at @ - , @ - and @-weeks .


Total of @ patients participated and were randomly allocated into placebo or HPS groups .


Total symptom score of NDI decreased after @-weeks trial in both groups ( p > @ ) .


HPS significantly improved QoL scores , especially in the area of ` interference and eat/drink ' in NDI ( p = @ ) as well as ` liveliness status ' , ` role-functioning status ' , and total score in FD-QoL ( p = @ for liveliness status and p = @ for role-functioning status ) .


This significant improvement of FD-QoL had lasted for @-weeks .


HPS treatment is markedly effective in improving QoL in patients with FD .


Moreover , we observed that this improvement had lasted for @ weeks after finishing the trial through the follow-up study .


The aim of the study was to compare two surgical methods of treating diaphyseal fractures of the humerus .


A prospective randomised study on the surgical treatment of humeral diaphyseal fractures was carried out between September @ and January @ .


The patients indicated for surgical treatment fell into two groups according to the technique used as follows : minimally invasive plate osteosynthesis ( MIPO ) with a locking compression plate ( LCP ; Synthes , Switzerland ) ; depending on the fracture type and course of fracture line , either a straight narrow or a Philos or a metaphyseal LCP was used ( group @ ) ; and intramedullary nailing ( EHN , Synthes , Switzerland ) ( group @ ) .


A total of @ patients were entered into the study .


The men-to-women ratio was about @:@ and the average age was @ years ( @ to @ ) .


Of them , @ patients with @ humeral fractures were followed up and evaluated .


The injury was caused by a fall from standing or while walking ( n = @ ) , traffic accident ( n = @ ) , sports activity ( n = @ ) or work-related activity ( n = @ ) .


A single injury was treated in @ % and multiple trauma in @ % of the patients .


Using the AO classification , fractures were diagnosed as types A , B and C in @ , @ and @ patients , respectively .


The patients were randomised into the groups using a computer programme allowing for the maintenance of group homogeneity .


Each patient received information on the method to be used in a sealed envelope .


The average injury-surgery interval was @ days ( range , @ to @ ) .


The average operative time was @ minutes ( @ to @ ) .


The average intra-operative exposure to X-ray was @ minutes ( @ to @ ) .


The average hospital stay was @ days ( @ to @ ) The average rehabilitation time till functional recovery was @ weeks ( @ to @ ) , the time of bone union by radiographic assessment was @ weeks ( @ to @ ) .


The functional outcome was assessed using the Constant-Murley ( CM ) and Liverpool Elbow Score ( LES ) systems .


The relative CM/LES score , as compared with the healthy extremity , was @/@ .


Excellent and good results were achieved in @ % and complications were recorded in @ % of the patients .


The most frequent complication was impingement syndrome or prolonged rehabilitation both in the patients with proximal humerus fractures managed with the Philos locking plate and in those treated by intramedullary nailing , although this was not necessarily due to a technical error , i.e. , osteosynthetic material protrusion .


Iatrogenic radial nerve injury was found only in one patient treated by intramedullary nailing and was associated with traction during reduction and nail insertion .


Pseudoarthrosis was recorded in one patient of each group and there were no infectious complications .


Intramedullary nailing has not yet shown such good outcomes in humeral as in tibial fractures .


The results of metaanalysis have indicated that humeral fractures treated by plate osteosynthesis have fewer complications and require repeat surgery less frequently .


However , as shown by most recent studies , this difference is getting smaller .


The MIPO technique was adopted at our department several years ago and the aim was to compare our results with those of other centres .


The studies so far published have show that MIPO and conventional open plate osteosynthesis give comparable outcomes .


CONCLUSIONS The statistical evaluation using the unpaired t-test did not show any significant differences in either the functional results or the number of complications between the two methods .


Both achieved about @ % of excellent and good results and had @ % of complications .


The only significant difference was found in the length of operative time ( @ min in MIPO versus @ min in EHN ) .


With use of the Chi-Square test , a significant correlation between AO fracture type and treatment outcome in the MIPO group was found , i.e. , no poor result was recorded for type A fractures , as assessed by the CM/LES score .


No such correlation between the fracture type and the functional outcome was seen in the EHN group .


Sociocommunicational deficits make it difficult for individuals with autism spectrum disorders ( ASD ) to understand communication content with conflicting verbal and nonverbal information .


Despite growing prospects for oxytocin as a therapeutic agent for ASD , no direct neurobiological evidence exists for oxytocin 's beneficial effects on this core symptom of ASD .


This is slowing clinical application of the neuropeptide .


To directly examine whether oxytocin has beneficial effects on the sociocommunicational deficits of ASD using both behavioral and neural measures .


At the University of Tokyo Hospital , we conducted a randomized , double-blind , placebo-controlled , within-subject-crossover , single-site experimental trial in which intranasal oxytocin and placebo were administered .


A total of @ highly functioning men with ASD participated and were randomized in the trial .


Single-dose intranasal administration of oxytocin ( @ IU ) and placebo .


Using functional magnetic resonance imaging , we examined effects of oxytocin on behavioral neural responses of the participants to a social psychological task .


In our previous case-control study using the same psychological task , when making decisions about social information with conflicting verbal and nonverbal contents , participants with ASD made judgments based on nonverbal contents less frequently with longer time and could not induce enough activation in the medial prefrontal cortex .


Therefore , our main outcomes and measures were the frequency of the nonverbal information-based judgments ( NVJs ) , the response time for NVJs , and brain activity of the medial prefrontal cortex during NVJs .


Intranasal oxytocin enabled the participants to make NVJs more frequently ( P = @ ) with shorter response time ( P = @ ) .


During the mitigated behavior , oxytocin increased the originally diminished brain activity in the medial prefrontal cortex ( P < @ ) .


Moreover , oxytocin enhanced functional coordination in the area ( P < @ ) , and the magnitude of these neural effects was predictive of the behavioral effects ( P @ ) .


These findings provide the first neurobiological evidence for oxytocin 's beneficial effects on sociocommunicational deficits of ASD and give us the initial account for neurobiological mechanisms underlying any beneficial effects of the neuropeptide .


Studies suggest that both affective and cognitive processes are involved in the perception of vulnerability to cancer and that affect has an early influence in this assessment of risk .


We constructed a path model based on a conceptual framework of heuristic reasoning ( affect , resemblance , and availability ) coupled with cognitive processes involved in developing personal models of cancer causation .


From an eligible cohort of @ women in a managed care organization , we randomly selected @ women at high , elevated , and average risk of ovarian cancer and administered a questionnaire to test our model ( response rate @ % ) .


Path analysis delineated the relationships between personal and cognitive characteristics ( number of relatives with cancer , age , ideas about cancer causation , perceived resemblance to an affected friend or relative , and ovarian cancer knowledge ) and emotional constructs ( closeness to an affected relative or friend , time spent processing the cancer experience , and cancer worry ) on perceived risk of ovarian cancer .


Our final model fit the data well ( root mean square error of approximation ( RMSEA ) = @ , comparative fit index ( CFI ) = @ , normed fit index ( NFI ) = @ ) .


This final model ( @ ) demonstrated the nature and direction of relationships between cognitive characteristics and perceived risk ; ( @ ) showed that time spent processing the cancer experience was associated with cancer worry ; and ( @ ) showed that cancer worry moderately influenced perceived risk .


Our results highlight the important role that family cancer experience has on cancer worry and shows how cancer experience translates into personal risk perceptions .


This understanding informs the discordance between medical or objective risk assessment and personal risk assessment .


Published in @ .


This article is a U.S. Government work and is in the public domain in the USA .


Knowledge of mitral valve prolapse ( MVP ) inheritance is based on pedigree observation and M-mode echocardiography .


The extent of familial clustering of MVP among unselected individuals in the community using current , more specific echocardiographic criteria is unknown .


In addition , the importance of nondiagnostic MVP morphologies ( NDMs ; first described in large pedigrees ) has not been investigated in the general population .


We hypothesized that parental MVP and NDMs increase the risk of offspring MVP .


Study participants were @ Generation @ individuals with available parental data in the Offspring or the New Offspring Spouse cohorts .


MVP and NDMs were distinguished by leaflet displacement > @ versus @ mm beyond the mitral annulus , respectively .


We compared MVP prevalence in Generation @ participants with at least @ parent with MVP ( n = @ ) with that in individuals without parental MVP ( n = @ ) .


Among @ participants ( @ % women ; mean age , @ years ) , @ ( @ % ) had MVP .


Parental MVP was associated with a higher prevalence of MVP in Generation @ participants ( @ of @ , @ % ) compared with no parental MVP ( @ of @ , @ % ; adjusted odds ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) .


When parental NDMs were examined alone , the prevalence of Generation @ MVP remained higher ( @ of @ , @ % ) compared with those without parental MVP or NDMs ( @ of @ , @ % ; adjusted odds ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Parental MVP and NDMs are associated with increased prevalence of offspring MVP , highlighting the genetic substrate of MVP and the potential clinical significance of NDMs in the community .


Oral presentations of clinical cases by medical students during medical rounds in hospital wards are a source of anxiety and little is known about how this anxiety can be alleviated .


The objective of this study was to investigate whether video-based feedback of public oral presentations can reduce anxiety in @th year medical students .


Multicentre randomized study conducted in six intensive care units ( ICU ) and emergency departments ( ED ) in France over a @-month period in @ .


One hundred and forty two @th year medical students were randomized to two groups : intervention and control .


Students in the intervention group were recorded while making an oral presentation of a patient during morning ward rounds , followed by video-based feedback .


Students in the control group conducted presented classical oral presentations without being filmed and with no formal feedback .


Anxiety levels during a public oral presentation were assessed using the Spielberger State Anxiety Inventory ( STAI-S ) .


The primary outcome was the difference in STAI-S scores between groups at the beginning and at the end of a @-month ICU or ED internship .


Seventy four students were randomized to the ` video-based feedback ' group and @ were randomized to the control group .


In both groups , STAI-S scores were significantly lower after @ months of internship .


However , the reduction in STAI-S scores was significantly greater in the `` video-based feedback '' group than in controls ( -@ vs. -@ , p = @ .


Compared to the control group , significantly fewer students with high-level anxiety were observed in the `` video-based feedback '' group after @ months of internship ( @ vs. @ % , p < @ ) .


Compared to `` usual practice '' , video-assisted oral feedback reduced anxiety and significantly decreased the proportion of students experiencing severe anxiety .


To test Stepping Stones Triple P ( SSTP ) and Acceptance and Commitment Therapy ( ACT ) in a trial targeting behavioral problems in children with cerebral palsy ( CP ) .


Sixty-seven parents ( @ % mothers ; mean age @ @ years ) of children ( @ % boys ; mean age @ @ years ) with CP ( Gross Motor Function Classification System = @ , @ % ; II = @ , @ % ; III = @ , @ % ; IV = @ , @ % ; V = @ , @ % ) participated and were randomly assigned to SSTP , SSTP + ACT , or waitlist .


Primary outcomes were behavioral and emotional problems ( Eyberg Child Behavior Inventory -LSB- ECBI -RSB- , Strengths and Difficulties Questionnaire -LSB- SDQ -RSB- ) and parenting style ( Parenting Scale -LSB- PS -RSB- ) at postintervention and @-month follow-up .


SSTP with ACT was associated with decreased behavioral problems ( ECBI Intensity mean difference -LSB- MD -RSB- = @ , confidence interval -LSB- CI -RSB- @ to @ , P = @ ; ECBI problem MD = @ , CI @ to @ , P < @ ) including hyperactivity ( SDQ MD = @ , CI @ to @ , P = @ ) , as well as decreased parental overreactivity ( PS MD = @ , CI @ to @ , P = @ ) and verbosity ( PS MD = @ , CI @ to @ , P = @ ) .


SSTP alone was associated with decreased behavioral problems ( ECBI problems MD = @ , CI @ to @ , P = @ ) and emotional symptoms ( SDQ MD = @ , CI @ to @ , P = @ ) .


Decreases in behavioral and emotional problems were maintained at follow-up .


SSTP is an effective intervention for behavioral problems in children with CP .


ACT delivers additive benefits .


Extremely preterm infants are at risk for neurodevelopmental impairment ( NDI ) .


Early cranial ultrasound ( CUS ) is usual practice , but near-term brain MRI has been reported to better predict outcomes .


We prospectively evaluated MRI white matter abnormality ( WMA ) and cerebellar lesions , and serial CUS adverse findings as predictors of outcomes at @ to @ months ' corrected age .


Early and late CUS , and brain MRI were read by masked central readers , in a large cohort ( n = @ ) of infants < @ weeks ' gestation surviving to near term in the Neonatal Research Network .


Outcomes included NDI or death after neuroimaging , and significant gross motor impairment or death , with NDI defined as cognitive composite score < @ , significant gross motor impairment , and severe hearing or visual impairment .


Multivariable models evaluated the relative predictive value of neuroimaging while controlling for other factors .


Of @ infants , @ died and @ were lost .


Increasing severity of WMA and significant cerebellar lesions on MRI were associated with adverse outcomes .


Cerebellar lesions were rarely identified by CUS .


In full multivariable models , both late CUS and MRI , but not early CUS , remained independently associated with NDI or death ( MRI cerebellar lesions : odds ratio , @ -LSB- @ % confidence interval : @-@ @ -RSB- ; late CUS : odds ratio , @ -LSB- @ % confidence interval : @-@ -RSB- ) , and significant gross motor impairment or death .


In models that did not include late CUS , MRI moderate-severe WMA was independently associated with adverse outcomes .


Both late CUS and near-term MRI abnormalities were associated with outcomes , independent of early CUS and other factors , underscoring the relative prognostic value of near-term neuroimaging .


The aim of this study was to assess the functional results of an early onset progressive eccentric and concentric training in patients with autogen hamstring anterior cruciate ligament ( ACL ) reconstruction .


Thirty-three patients with autogenous hamstring ACL reconstruction were randomly divided into study ( n = @ , mean age ; @ ) and control ( n = @ , mean age ; @ ) groups and followed the same ACL rehabilitation program .


Additionally , the study group followed a progressive eccentric and concentric training for @ weeks on the Monitorized Functional Squat System ( MFSS ) beginning @ weeks after surgery .


The groups were compared according to the isokinetic strength of the knee extensors and flexors , functional performance ( the vertical jump test , a single hop for distance test ) and the Lysholm knee scale , the Anterior Cruciate Ligament-Quality of Life Questionnaire ( ACL-QOL ) , before and @ weeks after the surgery .


The functional outcomes in terms of the vertical jump test ( p = @ ) , a single hop-for-distance test ( p = @ ) , the Lysholm knee scale ( p = @ ) and the ACL-QOL questionnaire ( p = @ ) demonstrated significantly greater improvement in the study group .


No significant difference was reported between groups for isokinetic strength of the knee extensors and flexors ( p > @ ) .


Adding progressive eccentric and concentric exercises to the standard rehabilitation protocol may improve the functional results after ACL reconstruction with autogen hamstring grafts .


To evaluate safety and efficacy of preoperative administration of enteral nutrition support in gastric cancer patients at risk of malnutrition .


A single center randomized controlled clinical trial was performed in @ gastric cancer patients in West China Hospital from May to October @ .


Thirty patients were given enteral nutrition support ( Ensure ( R ) ) manufactured by Abbott Laboratories for ten consecutive days before surgical operation in the treatment group , and @ patients were given an isocaloric and isonitrogenous homogenized diet in the control group for @ days as well .


The laboratory parameters of nutritional status and hepatorenal function were observed and compared between the two groups on admission , preoperative day @ and postoperative day @ , respectively .


Clinical observations , such as nausea and vomiting , were carried out until patients were discharged .


Before the intervention , there were no significant differences in the baseline characteristics between the two groups .


The levels of serum albumin -LSB- ( @ ) g/L vs. ( @ ) g/L , P < @ -RSB- , and hemoglobin -LSB- ( @ ) g/L vs. ( @ ) g/L , P < @ -RSB- were significantly improved in the treatment group on postoperative day @ .


However , the levels of body mass index , lymphocyte count , liver and renal function , serum glucose , sodium , and potassium were not significantly different between the two groups ( all P > @ ) .


Moreover , two patients with nausea and one with vomiting in each group were found .


In clinical observation period , no severe treatment-related adverse event were observed .


The enteral supplement with Ensure ( R ) in gastric cancer patients at risk of malnutrition during preoperative period is effective and safe , which is superior to homogenized diet and an appropriate choice for gastric cancer patients with nutritional risk .


Inflammation may play an important role in type @ diabetes .


It has been proposed that dietary strategies can modulate inflammatory activity .


We investigated the effects of diet on inflammation in type @ diabetes by comparing a traditional low-fat diet ( LFD ) with a low-carbohydrate diet ( LCD ) .


Patients with type @ diabetes were randomized to follow either LFD aiming for @-@ energy per cent ( E % ) from carbohydrates ( n = @ ) or LCD aiming for @ E % from carbohydrates ( n = @ ) .


Plasma was collected at baseline and after @ months .


C-reactive protein ( CRP ) , interleukin-@ receptor antagonist ( IL-@Ra ) , IL-@ , tumour necrosis factor receptor ( TNFR ) @ and TNFR@ were determined .


Both LFD and LCD led to similar reductions in body weight , while beneficial effects on glycaemic control were observed in the LCD group only .


After @ months , the levels of IL-@Ra and IL-@ were significantly lower in the LCD group than in the LFD group , @ ( @-@ ) versus @ ( @-@ ) pg/mL and @ ( @-@ @ ) versus @ ( @-@ @ ) pg/mL , both P < @ .


To conclude , advice to follow LCD or LFD had similar effects on weight reduction while effects on inflammation differed .


Only LCD was found significantly to improve the subclinical inflammatory state in type @ diabetes .


To investigate the safety/efficacy of Boceprevir-based triple therapy in hepatitis C virus ( HCV ) - G@ menopausal women who were historic relapsers , partial-responders and null-responders .


In this single-assignment , unblinded study , we treated fifty-six menopausal women with HCV-G@ , @ % F@-F@ , and previous PEG - / RBV failure ( @ % null , @ % non-responder , and @ % relapser ) with @ wk lead-in with PEG-IFN@b / RBV followed by PEG-IFN@b / RBV+B oceprevir for @ wk , with an additional @ wk of PEG-IFN -- @b/RBV if patients were HCV-RNA-positive by week @ .


In previous null-responders , @ wk of triple therapy was used .


The primary objective of retreatment was to verify whether a sustained virological response ( SVR ) ( HCV RNA undetectable at @ wk of follow-up ) rate of at least @ % could be obtained .


The secondary objective was the evaluation of the percent of patients with negative HCV RNA at week @ ( RVR ) , @ ( RVR BOC ) , @ ( EVR ) , or at the end-of-treatment ( ETR ) that reached SVR .


To assess the relationship between SVR and clinical and biochemical parameters , multiple logistic regression analysis was used .


After lead-in , only two patients had RVR ; HCV-RNA was unchanged in all but @ % who had @ log@ decrease .


After Boceprevir , HCV RNA became undetectable at week @ in @/@ ( @ % ) and at week @ in @/@ ( @ % ) .


Of these , @ % and @ % , respectively , achieved SVR .


Overall , SVR was obtained in @/@ ( @ % ) .


SVR was achieved in @ % previous relapsers vs. @ % non-responders ( P = @ ) , in @ % F@-F@ vs @ % F@-F@ ( P = @ ) , and in @/@ ( @ % ) of patients with cirrhosis .


At univariate analysis for baseline predictors of SVR , only previous response to antiviral therapy ( OR = @ , @ % CI : @-@ @ , P = @ ) , was related with SVR .


When considering `` on treatment '' factors , @ log@ HCV RNA decline at week @ ( @ , @ % CI : @-@ @ , P = @ ) and achievement of RVR BOC ( @ , @ % CI : @-@ @ , P = @ ) were significantly related with the SVR , although RVR BOC only ( @ , @ % CI : @-@ @ , P = @ ) maintained significance at multivariate logistic regression analysis .


Anemia and neutropenia were managed with Erythropoietin and Filgrastim supplementation , respectively .


Only six patients discontinued therapy .


Boceprevir obtained high SVR response independent of previous response , RVR or baseline fibrosis or cirrhosis .


RVR BOC was the only independent predictor of SVR .


To compare the efficacy of oral Montelukast and inhaled Budesonide as a first line preventive therapy in mild persistent asthma in age group @-@ y.


This prospective randomized controlled clinical study was conducted for @ wk .


Sixty patients of mild persistent asthma aged @ to @ y were randomly allocated to either oral Montelukast ( n = @ ) or inhaled Budesonide ( n = @ ) group .


Outcomes measured were improvement in peak expiratory flow rate ( PEFR ) , forced expiratory volume @s/forced vital capacity ( FEV@/FVC ) , day time and night time symptoms and frequency of exacerbations and need to change medications .


There was significant improvement in PEFR , FEV@/FVC , day time and night time symptoms and frequency of exacerbations in both groups .


However , more significant improvement in FEV@/FVC ( CI @ % , p = @ ) and day time symptoms ( CI @ % , p = @ ) was seen in Budesonide group compared to Montelukast group .


The present study suggests that oral Montelukast is not inferior to Budesonide in treatment of mild persistent asthma in @ to @ y children in terms of control of symptoms and improvement in pulmonary function tests over a @ wk period .


However , there was more significant improvement in day time symptoms , more significant increase in FEV@/FVC ratio and less exacerbation in patients receiving Budesonide compared to those receiving Montelukast .


However , side effects due to long term use of steroids such as growth stunting and bone osteopenia should also be considered before recommending .


Trial registered at CTRI no .


REF/@/@ / @ .


Respiratory syncytial virus ( RSV ) is a common cause of infant hospitalizations and is increasingly recognized as a cause of considerable morbidity and mortality .


No accepted antiviral treatment exists .


We conducted a double-blind , placebo-controlled study of GS-@ , an oral RSV-entry inhibitor , in healthy adults who received a clinical challenge strain of RSV intranasally .


Participants were monitored for @ days .


At the time of a positive test for RSV infection or @ days after inoculation , whichever occurred first , participants were randomly assigned to receive GS-@ or placebo in one of seven sequential cohorts .


Cohorts @ to @ received a first dose of @ mg of GS-@ and then @ mg daily for the next @ days , cohort @ received a first dose of @ mg and then @ mg daily for the next @ days , cohort @ received one @-mg dose , and cohort @ received a first dose of @ mg and then @ mg daily for the next @ days .


Dose selection for cohorts @ , @ , and @ occurred after an interim analysis of data for cohorts @ to @ .


The primary end point was the area under the curve ( AUC ) for the viral load , which was assessed after administration of the first dose through the @th day after inoculation .


Secondary end points were mucus weight and symptom scores .


Among the @ participants in cohorts @ to @ who were infected with RSV , active treatment was associated with a lower viral load ( adjusted mean , @ vs. @ log@ plaque-forming-unit equivalents -LSB- PFUe -RSB- hours per milliliter ; P < @ ) , lower total mucus weight ( mean , @ g vs. @ g ; P = @ ) , and a lower AUC for the change from baseline in symptom scores ( adjusted mean , -@ vs. @ hours ; P = @ ) .


The results were similar in cohorts @ , @ , and @ .


Adverse events , including low neutrophil counts and increased levels of alanine aminotransferase , were more common among participants receiving GS-@ .


Treatment with GS-@ reduced the viral load and the severity of clinical disease in a challenge study of healthy adults .


( Funded by Gilead Sciences ; ClinicalTrials.gov number , NCT@ . )


Systematic reporting of funding sources is recommended in the CONSORT Statement for abstracts .


However , no specific recommendation is related to the reporting of conflicts of interest ( CoI ) .


The objective was to compare physicians ' confidence in the conclusions of abstracts of randomized controlled trials of pharmaceutical treatment indexed in PubMed .


We planned a three-arm parallel-group randomized trial .


French general practitioners ( GPs ) were invited to participate and were blinded to the study 's aim .


We used a representative sample of @ abstracts of pharmaceutical industry-funded randomized controlled trials published in @ and indexed in PubMed .


Each abstract was standardized and reported in three formats : @ ) no mention of the funding source or CoI ; @ ) reporting the funding source only ; and @ ) reporting the funding source and CoI .


GPs were randomized according to a computerized randomization on a secure Internet system at a @:@:@ ratio to assess one abstract among the three formats .


The primary outcome was GPs ' confidence in the abstract conclusions ( @ , not at all , to @ , completely confident ) .


The study was planned to detect a large difference with an effect size of @ .


Between October @ and June @ , among @ GPs contacted , @ were randomized , @ for each type of abstract .


The mean difference ( @ % confidence interval ) in GPs ' confidence in abstract findings was @ ( -@ ; @ ) ( P = @ ) for abstracts reporting the funding source only versus no funding source or CoI ; -@ ( -@ ; @ ) ( P = @ ) for abstracts reporting the funding source and CoI versus no funding source and CoI ; and -@ ( -@ ; @ ) ( P = @ ) for abstracts reporting the funding source and CoI versus the funding source only .


We found no evidence of a large impact of trial report abstracts mentioning funding sources or CoI on GPs ' confidence in the conclusions of the abstracts .


Extended systemic lymphadenectomy ( D@ ) is standard procedure for surgical treatment of advanced gastric cancer ( AGC ) although less extensive lymphadenectomy ( D@ ) can be applied to early gastric cancer .


Complete D@ lymphadenectomy is the mandatory procedure for studies that evaluate surgical treatment results of AGC .


However , the actual extent of D@ lymphadenectomy varies among surgeons because of a lacking consensus on the anatomical definition of each lymph node station .


This study is aimed to develop a consensus for D@ lymphadenectomy and also to qualify surgeons that can perform both laparoscopic and open D@ gastrectomy .


This ( KLASS-@-QC ) is a prospective , observational , multicenter study to qualify the surgeons that will participate in the KLASS-@-RCT , which is a prospective , randomized , clinical trial comparing laparoscopic and open gastrectomy for AGC .


Surgeons and reviewers participating in the study will be required to complete a questionnaire detailing their professional experience and specific gastrectomy surgical background/training , and the gastrectomy metrics of their primary hospitals .


All surgeons must submit three laparoscopic and three open D@ gastrectomy videos , respectively .


Each video will be allocated to five peer reviewers ; thus each surgeon 's operations will be assessed by a total of @ reviews .


Based on blinded assessment of unedited videos by experts ' review , a separate review evaluation committee will decide whether or not the evaluated surgeon will participate in the KLASS-@-RCT .


The primary outcome measure is each surgeon 's proficiency , as assessed by the reviewers based on evaluation criteria for completeness of D@ lymphadenectomy .


We believe that our study for standardization of D@ lymphadenectomy and surgical quality control ( KLASS-@-QC ) will guarantee successful implementation of the subsequent KLASS-@-RCT study .


After making consensus on D@ lymphadenectomy , we developed evaluation criteria for completeness of D@ lymphadenectomy .


We also developed a unique surgical standardization and quality control system that consists of recording unedited surgical videos , and expert review according to evaluation criteria for completeness of D@ lymphadenectomy .


We hope our systematic approach will set a milestone in surgical standardization that is essential for surgical clinical trials .


Additionally , our methods will serve as a novel system for educating surgeons and assessing surgical proficiency .


Approximately @ % of HIV-@-infected patients receiving antiretroviral therapy who achieve virologic control have unsatisfactory immune reconstitution , with CD@ + T-cell counts persistently below @ cells/L .


These patients are at elevated risk for clinical progression to AIDS and non-AIDS events .


CD@ + T-cell depletion following infection and persistent immune activation can partially explain this low CD@ + T-cell recovery .


Recent data suggest a link between the tryptophan oxidation pathway , immune activation and HIV disease progression based on overstimulation of the tryptophan oxidation pathway by HIV antigens and by interferon-gamma .


This overstimulation reduces levels of circulating tryptophan , resulting in inflammation which has been implicated in the development of neurocognitive dysfunction .


Niacin ( vitamin B@ ) is able to control the excess tryptophan oxidation , correcting tryptophan depletion , and therefore represents an interesting strategy to improve CD@ recovery.We aim to design a crossover proof-of-concept study to assess supplementation with an extended-release form of niacin ( Niaspan FCT ) in combination with antiretroviral therapy , compared to antiretroviral therapy alone , on T-cell immune activation as defined by changes in the percentage of CD@ + CD@ + HLA-DR + T-cells .


This randomized , open-label , interventional crossover study with an immediate versus deferred use of Niaspan FCT for @ weeks will assess its ability to reduce immune activation and thus increase CD@ recovery in @ HIV-infected individuals with suboptimal immune responses despite sustained virologic suppression .


A substudy evaluating neurocognitive function will also be conducted .


This randomized trial will provide an opportunity to evaluate the potential benefit of oral extended-release niacin , a drug that can indirectly increase tryptophan , to reduce immune activation and in turn increase CD@ + T-cell recovery .


The study will also allow for the evaluation of the impact of Niaspan FCT on neurocognitive function in HIV-infected individuals with suboptimal immune responses despite sustained virologic suppression .


We examined how individual motivational orientations and anticipated regret are related to the protective health decision of vaccination behaviour .


The proposed relations were examined in a large-scale sample ( N = @ ) and three medium-sized samples ( N = @ , N = @ , N = @ ) .


Questionnaires were applied to assess regulatory focus , anticipated regret and vaccination behaviour .


Increased prevention-focused self-regulation - which is represented by concerns about security-related goals , responsibilities and obligations - was related to a greater likelihood of vaccination .


Prevention-focused individuals ' higher likelihood of getting vaccinated seems at least in part to be a consequence of anticipated regret for not vaccinating .


Study @ suggests that regulatory focus is less related to vaccination decisions when regret is increased by the decision-making context ; that is , when information highlighting vaccination effectiveness and a low likelihood of adverse responses is provided .


Prevention-focused self-regulation is related to a greater likelihood of engaging in health-protective behaviour .


This can be explained by prevention-focused individuals ' greater tendency to anticipate regret about getting ill as a consequence of not adopting protective measures .


If people perceive a protective measure such as a vaccination as highly effective , anticipated regret for not adopting it is generally increased , and individual differences in regulatory focus no longer predict the decision .


Individuals with mixed dyslipidemia have elevated triglycerides ( TG ) , low high-density lipoprotein cholesterol ( HDL-C ) , and increased risk for coronary disease .


Fibrate therapy is commonly used to lower TG and increase HDL-C .


Common genetic variants are known to affect the response to fibrate therapy .


We sought to identify rare genetic variants ( frequency @ % ) in genes involved in TG and HDL-C metabolism that affect the response to fenofibric acid ( FA ) therapy .


Four genes with a major role in HDL-C and TG metabolism APOA@ , APOC@ , APOC-III and LPL were sequenced in @ participants with mixed dyslipidemia in a randomized , double-blind , active-controlled study comparing therapy with FA alone , in combination with statins , or statin alone .


Rare variants collapsing or SKAT methods were used for the analysis .


Synonymous rare variants in the LPL gene were significantly associated with absolute HDL-C change ( P = @ @ ( -@ ) ) and TG percent change ( P = @ @ ( -@ ) ) in those treated with FA only .


Participants with these rare variants had a @ mg/dL increase in HDL-C and @ mg/dL decrease in TG as compared to @ mg/dL increase in HDL-C and @ mg/dL decrease in TG in those without these variants .


Rare variants in the APOC-III gene were associated with a modest @ mg/dL less reduction in APOB ( P = @ @ ( -@ ) ) in those receiving FA and statin .


In individuals with mixed dyslipidemia rare synonymous variants within LPL gene were associated with attenuated response to FA therapy while APOCIII rare variants were associated with a modest effect on APOB response to FA-statin therapy .


These results should be replicated in a similar clinical trial for further confirmation .


Alternative therapies for childhood obstructive sleep apnea syndrome ( OSAS ) are needed as OSAS may persist despite adenotonsillectomy , and continuous positive airway pressure ( CPAP ) adherence is low .


Nasal expiratory positive airway pressure ( NEPAP ) devices have not been studied in children .


We hypothesized that NEPAP would result in polysomnographic improvement .


Further , we aimed to determine NEPAP adherence , effects on sleepiness , behavior , and quality of life .


A randomized , double-blind , placebo-controlled , crossover pilot study was performed .


CPAP candidates , @-@ years old , underwent NEPAP and placebo polysomnograms .


Subjects with @ % reduction in the apnea hypopnea index ( AHI ) from placebo to NEPAP night or AHI < @/h on NEPAP night wore NEPAP at home for @ days .


Adherence was assessed by daily phone calls/emails and collecting used devices .


Fourteen subjects ( age @ @ years , BMI z-scores @ @ -LSB- mean SD -RSB- ) were studied .


There was significant improvement in the obstructive apnea index with NEPAP vs. placebo : @ ( @-@ @ ) / h vs. @ ( @-@ @ ) / h ( median -LSB- range -RSB- , p = @ ) and trends for improvement in other polysomnographic parameters .


However , responses were variable , with @ subjects not improving and @ worsening .


Older children and those with less hypercapnia had a better response .


Eight subjects were sent home with devices ; one was lost to follow-up , and adherence in the remainder was @ % of nights ; these subjects had a significant improvement in sleepiness and quality of life .


NEPAP devices are a potential alternative therapy for OSAS in a small subset of children .


Due to variability in individual responses , efficacy of NEPAP should be evaluated with polysomnography .


Botulinum toxin A injection into the nonparalyzed side is used to treat asymmetry resulting from facial palsy .


OnabotulinumtoxinA and abobotulinumtoxinA units are not equivalent .


The authors compared the conversion ratio of @:@ in patients with facial palsy .


Fifty-five patients ( age , @ to @ years ; @ women ) with longstanding facial palsy were randomly treated with either onabotulinumtoxinA ( n = @ ) or abobotulinumtoxinA ( n = @ ) injections into the nonparalyzed side .


Adverse effects , facial symmetry , subjective satisfaction , and Facial Disability Index were assessed after @ and @ months .


The incidence of adverse effects was higher with abobotulinumtoxinA ( @ percent versus @ percent ; p = @ ) .


Clinical scores of the nonparalyzed side decreased after @ month and increased again at @ months , with no between-group differences .


Scores of the paralyzed side were lower in the onabotulinumtoxinA group before treatment , but similar in both groups thereafter .


The paralyzed side scores increased after @ month , and at @ months were still higher than the pretreatment scores in both groups .


Subjective assessment improved at all time points compared with pretreatment scores and differed between the two groups only at @ month , when the abobotulinumtoxinA group was a bit too paralyzed .


The physical function and social/well-being function subscales of the Facial Disability Index did not differ between the two groups .


Both toxins efficiently reduced asymmetry in patients with facial palsy .


Adverse effects were higher with abobotulinumtoxinA at an equivalence ratio of @:@ .


Therapeutic , II .


Burn patients are at risk of hypovitaminosis D and osteopenia or sarcopenia .


Vitamin D pleiotropic effects may influence bone and muscle health .


The aim of this pilot study was to assess effects of a cholecalciferol ( VD@ ) supplementation and an optimized calcium ( Ca ) regimen on vitamin D ( VD ) status , bone and muscle health during sequelar stage of burn injury .


Monocentric randomized controlled trial .


Fifteen adults with thermal burns dating from @ to @ years were randomized into two groups .


For @ months , they either received a quarterly IM injection of @,@ IU VD@ and daily oral Ca ( Group D ) or placebo ( Group P ) .


VD status and bone remodeling markers were assessed every @ months .


Knee muscle strength and bone mineral density were , respectively , assessed using isokinetic dynamometry and dual X-ray absorptiometry at initiation ( M@ ) and completion ( M@ ) of the protocol .


Of all the patients , @ % presented with VD deficiency and @ % ( with @ men < @y ) were considered osteopenic at inclusion .


After one year , calcidiol levels significantly increased in Group D to reach @ ( @-@ ) ng/ml .


No significant change in bone health was observed in both groups while Group D significantly improved quadriceps strength when tested at high velocity .


This VD@ supplementation was safe and efficient to correct hypovitaminosis D in burn adults .


When combined with optimized Ca intakes , it demonstrated positive effects on muscle health but not on bone health .


A high prevalence of hypovitaminosis D and osteopenia in these patients , as well as their wide range of muscle performances , seem to be worrying when considering rehabilitation and quality of life .


To examine in patients with early rheumatoid arthritis ( RA ) whether quality of life ( QoL ) , independently of disease activity , is affected by tight control treatment strategy schemes .


In the Computer Assisted Management in Early RA ( CAMERA ) trials , patients with early RA , disease duration < @ year , no prior use of DMARDs ) had been randomised to a methotrexate ( MTX ) - based tight control strategy or usual care ( CAMERA study ) or to @ mg/d prednisone or placebo both added from start to a MTX-based tight control strategy ( CAMERA-II study ) .


In either study , randomisation to the more intensive strategy resulted in lower disease activity .


To assess QoL , the ` Influence of Rheumatic Diseases on General Health and Lifestyle ' questionnaire ( IRGL ) was used .


Baseline and @ - and/or @-year measurements were analysed with regression analyses with the IRGL ( sub ) scales as outcome variables and treatment strategy and disease activity assessing @ joints ( DAS@ ) as independent variables , correcting for baseline values of each scale and possible confounders ( gender , age , rheumatoid factor status ) .


There was no clear association between either of the treatment strategies and QoL , but a decrease in DAS@ was associated with improvement in the majority of QoL ( sub ) scales .


No independent effect of the specific tight control strategies schemes on QoL was found , while there was a clear disease activity related effect .


Thus frequent outpatient visits or the inclusion of prednisone in a tight control strategy did not negatively influence QoL .


One of the main causes of mortality and morbidity following subarachnoid hemorrhage ( SAH ) is the development of cerebral vasospasm , a frequent complication arising in the weeks after the initial bleeding .


Despite extensive research , no effective treatment of vasospasm exists to date .


Prostacyclin is a potent vasodilator and inhibitor of platelet aggregation .


In vitro models have shown a relaxing effect of prostacyclin after induced contraction in cerebral arteries , and a recent pilot trial showed a positive effect on cerebral vasospasm in a clinical setting .


No randomized clinical trials have investigated the possible pharmacodynamic effects of prostacyclin on the human brain following SAH .


This trial is a single centre , randomized , placebo-controlled , parallel group , double blinded , clinical pilot trial .


A total of @ patients with SAH will be randomized to one of three intervention arms : epoprostenol at @ ng/kg/min , epoprostenol at @ ng/kg/min , or placebo in addition to the standard treatment .


Trial medication will start on Day @ after SAH and continue to Day @ .


The primary outcome measure is changes in cerebral blood flow measured by a computed tomography ( CT ) perfusion scan .


The secondary outcomes are vasospasm measured by a CT angiography , regional blood flow , clinical symptoms of cerebral ischemia , and outcome at three months ( Glasgow Outcome Scale ) .


The primary outcome has been altered slightly since the publication of our study protocol .


Global cerebral blood flow is now primary outcome , whereas regional blood flow is a secondary outcome .


Participatory patient-centered , web-based methods could streamline and improve the convenience of clinical trial participation .


We used an entirely web-based approach to conduct a randomized , placebo-controlled , Phase @ ( REMOTE ) trial under an Investigational New Drug ( IND ) application to evaluate tolterodine extended release ( ER ) @ mg for overactive bladder .


The trial was designed to replicate previous clinic-based trials of tolterodine ER but was conducted via the web from one clinical site overseen by physicians .


Participants were recruited via the web , screened for eligibility using web-based questionnaires , had laboratory testing in their community , and entered a run-in phase requiring bladder e-diaries .


Informed consent was obtained using an interactive web-based method with physician countersignature .


Study medication was shipped directly to participants .


With a goal of @ randomized participants , @ registered on the trial website .


Of @ who passed initial screening , identification verification , and signed consent , @ passed additional medical screening and were countersigned by the investigator .


After laboratory testing , @ entered the placebo run-in ; only @ passed e-diary assessments and were randomized to treatment .


At week @ , the mean change from the baseline in micturitions/@ hours ( primary endpoint ) was -@ for tolterodine ER versus -@ for placebo -LSB- treatment difference ( @ % CI ) : -@ ( -@ , @ ) -RSB- .


The REMOTE trial is the first entirely web-based trial conducted under an IND application .


The efficacy observed was consistent with results from conventional trials .


With simplification of multi-step screening and testing , web-based trials or their component parts should provide a participant-friendly approach to many clinical trials .


Increasing demand for palliative care unit ( PCU ) admissions has led to a stronger focus on discharge planning .


This has resulted in shorter inpatient length of stays ( LOS ) , and stable patients not requiring specialist palliative care services being referred for placement in residential aged care facilities ( RACFs ) .


The process of placement is time-consuming and can be distressing to patients and families , so RACF placement should only be proposed in patients whose prognosis is relatively good ( i.e. , weeks to months ) .


Our aim was to identify the outcomes of palliative care inpatients referred for residential aged care placement .


A retrospective chart audit was conducted .


The patients ' outcomes ( discharge or death and survival time ) were recorded and analyzed using SPSS statistical software .


Subjects were @ consecutive inpatients from a @-bed PCU who had been referred for RACF placement .


Of the @ patients referred for RACF placement @ of @ ( @ % ) patients had a malignant diagnosis , whereas @ ( @ % ) had a noncancer diagnosis .


Thirty-eight ( @ % ) patients died before discharge , including @ of @ ( @ % ) patients with cancer and @ of @ ( @ % ) patients with nonmalignant conditions .


In particular , @ of @ ( @ % ) patients with metastatic non-small cell lung ( NCSLC ) cancer died before or soon after discharge .


Over one-third of all patients died before discharge to an RACF could take place .


The rate of death before discharge was higher among patients who had cancer .


Patients suffering from NCSLC need to be more carefully selected for placement as only one-third of these patients survived to discharge .


Human patient simulation has been widely adopted in healthcare education despite little research supporting its efficacy .


The debriefing process is central to simulation education , yet alternative evaluation methods to support providing optimal feedback to students have not been well explored .


Eye tracking technology is an innovative method for providing objective evaluative feedback to students after a simulation experience .


The purpose of this study was to compare @ forms of simulation-based student feedback ( verbal debrief only , eye tracking only , and combined verbal debrief and eye tracking ) to determine the most effective method for improving student knowledge and performance .


An experimental study using a pretest-posttest design was used to compare the effectiveness of @ types of feedback .


The subjects were senior baccalaureate nursing students in their final semester enrolled at a large university in the northeast United States .


Students were randomly assigned to @ of the @ intervention groups .


All groups performed better in the posttest evaluation than in the pretest .


Certain safety practices improved significantly in the eye tracking-only group .


These criteria were those that required an auditory and visual comparison of @ artifacts such as `` Compares patient stated name with name on ID band . ''


Eye tracking offers a unique opportunity to provide students with objective data about their behaviors during simulation experiences , particularly related to safety practices that involve the comparison of patient stated data to an artifact such as an ID band .


Despite the limitations of current eye tracking technology , there is significant potential for the use of this technology as a method for the study and evaluation of patient safety practices .


The Absorb everolimus-eluting bioresorbable vascular scaffold ( AbsorbBVS ) is a completely resorbable device engineered to overcome the limitations of permanent metallic stents , providing temporary scaffolding and antiproliferative drug delivery for the treatment of obstructive coronary artery disease .


The objective of the AIDA trial is to evaluate the efficacy and performance in an contemporary all-comer population of the AbsorbBVS strategy vs the XIENCE family everolimus-eluting metallic coronary stent system in the treatment of coronary lesions .


The AIDA trial is a prospective , randomized ( @:@ ) , active-control , single-blinded , all-comer , noninferiority trial .


A total of @,@ subjects will be enrolled with broad inclusion and limited exclusion criteria according to the `` Instructions for Use '' of the AbsorbBVS strategy .


The study population includes both simple and complex lesions , in patients with stable and acute coronary syndrome .


The follow-up continues for @years .


The primary end point of the trial is target vessel failure , defined as the composite of cardiac death , myocardial infarction , and target vessel revascularization , at @years .


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


The AIDA trial will provide the first randomized direct comparison between the everolimus-eluting bioresorbable vascular scaffold and the everolimus-eluting metallic stent in contemporary percutaneous coronary intervention practice .


Lateral epicondylitis , commonly known as tennis elbow , is the most common cause of lateral elbow pain and the second most frequently diagnosed musculoskeletal disorder in the neck and upper limb in a primary care setting .


Many therapeutic options , including conservative , surgical , and minimally invasive procedures , have been advocated for the treatment of lateral epicondylitis .


Although numerous small studies have been performed to assess the efficacy of various treatments , there are conflicting results with no clear consensus on the optimal treatment .


In an economic environment with limited health care resources , it is paramount that optimal cost-effective therapies with favorable patient-important outcomes be identified .


This is a protocol paper which outlines a multicenter , multidisciplinary , single-blinded , four-arm randomized controlled trial , comparing platelet-rich plasma ( PRP ) , whole blood injection , dry needle tendon fenestration , and sham injection with physical therapy alone for the treatment of lateral epicondylitis .


Patients are screened based on pre-established eligibility criteria and randomized to one of the four study groups using an Internet-based system .


The patients are followed at @-week , @-week , @-week , and @-week time points to assess the primary and secondary outcomes of the study .


The primary outcome is pain .


Secondary outcomes include health-related quality of life and ultrasound appearance of the common extensor tendon .


Two university centers ( McMaster University and the University of Michigan ) are currently recruiting patients .


We have planned a sample size of @ patients ( @ patients per arm ) to ensure over @ % power to detect a three-point difference in pain scores at @weeks of follow-up .


Fatigue is a common symptom of chronic hepatitis C virus ( HCV ) infection and a frequent side-effect of peginterferon/ribavirin ( PR ) therapy for HCV .


This study evaluated the impact of adding the oral HCV NS@/@A protease inhibitor simeprevir to PR on patient-reported fatigue and health status among patients with chronic HCV genotype @ infection enrolled in the Phase IIb PILLAR and ASPIRE trials -LSB- NCT@ ; NCT@ -RSB- .


Treatment-nave patients ( PILLAR , n = @ ) and treatment-experienced patients ( ASPIRE , n = @ ) were randomized to simeprevir plus PR ( simeprevir/PR ) or placebo plus PR ( placebo/PR ) .


In PILLAR , duration of PR treatment in the simeprevir/PR groups was determined using response-guided therapy ( RGT ) criteria .


PR could be terminated at Week @ , instead of Week @ , if HCV RNA was < @IU/mL by Week @ and then undetectable at Weeks @ , @ , and @ .


In both studies , patients completed the Fatigue Severity Scale ( FSS ) and EQ-@D quality-of-life questionnaire in their native language at baseline and throughout the studies up until Week @ .


During the first @weeks of treatment , mean FSS total score was increased to a similar degree compared with baseline among patients receiving simeprevir/PR or placebo/PR in both studies indicating increased fatigue severity .


Mean FSS scores returned to values comparable with baseline among patients receiving simeprevir/PR after Week @ in PILLAR ( after treatment completion for the majority of patients ) and in ASPIRE ( after Week @ ) , consistent with RGT enabling early termination of all treatment at Week @ in @ % of simeprevir/PR-treated patients in the PILLAR study .


Similar results were observed for EQ-@D , with simeprevir/PR-treated patients experiencing less time with worse health problems according to EQ-@D scores compared with placebo/PR groups in both studies , and more rapid improvement in health status associated with shorter treatment duration in the PILLAR study .


Combination of simeprevir with PR did not increase patient-reported fatigue severity or health status impairments beyond that reported by patients treated with PR alone .


Many patients treated with simeprevir/PR returned to pretreatment fatigue and health status levels sooner due to increased treatment efficacy that enabled shorter duration of all therapy , compared with PR alone .


The development of specific antibodies against human leukocyte antigen ( HLA ) and/or human platelet antigen ( HPA ) could induce platelet transfusion refractoriness especially in patients receiving multiple platelet transfusions .


A retrospective analysis was conducted to evaluate the prevalence of platelet-specific antibodies and the efficacy of crossmatch-compatible platelet transfusions in these recipients .


All enrolled patients were refractory to random single-donor apheresis Platelet ( PLT ) units .


Enzyme-linked immunosorbent assay ( ELISA ) was used to detect anti-HLA and anti-HPA antibodies in serum .


For those patients with antibodies , the PLT crossmatch assays were performed to select the compatible PLTs with a commercial solid-phase adherence kit .


A total of @ patients were included and @ % of which was HLA and/or HPA antibody-positive .


There were no significant differences in antibody-positive rates among AML/CML , ALL/CLL , MDS , SAA and ITP groups , but they are statistically significantly higher than other groups ( P = @ ) .


Of those antibody-positive patients , there were @ ( @ % ) patients with only HLA antibodies , @ ( @ % ) patients with only HPA antibodies and @ ( @ % ) patients with both HLA and HPA antibodies .


A total of @ random PLT units and @ crossmatch-compatible PLT units were administered .


The mean ( SD ) corrected count increment ( CCI ) was @ ( @ ) after crossmatch-compatible unit transfusion , significantly higher than @ ( @ ) for random PLT units ( P < @ ) .


HLA and/or HPA alloimmunisation is an important factor to cause refractoriness to platelet transfusions .


Crossmatch-compatible platelet transfusion is an effective method in those patients refractory to random platelet transfusions .


Volume expansion and hypertension are widely used for the hemodynamic management of patients with subarachnoid hemorrhage .


To investigate the feasibility , adherence , and retention in a trial of volume expansion and blood pressure manipulation to prevent delayed cerebral ischemia .


A randomized pilot trial using a @-way factorial design allocating patients within @ hours of subarachnoid hemorrhage to either normovolemia ( NV ) or volume expansion ( HV ) and simultaneously to conventional ( CBP ) or augmented blood pressure ( ABP ) for @ days .


The study endpoints were protocol adherence and retention to follow-up .


The quality of endpoints for a larger trial were @-month modified Rankin Scale score , comprehensive neurobehavioral assessment , delayed cerebral ischemia , new stroke , and discharge disposition .


Twenty patients were randomized and completed follow-up .


The overall difference in daily mean intravenous fluid intake was @ mL ( @ % confidence interval -LSB- CI -RSB- : @ , @ ) , HV vs NV group .


The overall mean systolic blood pressure difference was @ mm Hg ( @ % CI : -@ , @ ) , ABP vs CBP group .


Adverse events included death ( n = @ ) , delayed cerebral ischemia ( n = @ ) , and pulmonary complications ( n = @ ) .


There were no differences in modified Rankin Scale score between HV and NV ( difference @ ; @ % CI : -@ , @ , P = @ ) or between ABP and CBP groups ( -@ , @ % CI : -@ , @ , P = @ ) .


Neuropsychological scores were similar between HV vs NV , but tended to be worse in ABP ( @ ) vs CBP group ( @ , P = @ ) .


This pilot study showed adequate feasibility and excellent retention to follow-up .


Given the suggestion of possible worse neurobehavioral outcome with ABP , a larger trial to determine the optimal blood pressure management in this patient population is warranted .


( ClinTrials.gov NCT@ . )


Complementing infant diets with lipid-based nutrient supplements ( LNSs ) has been suggested to improve growth and reduce morbidity , but the daily quantity and the milk content of LNSs affect their cost .


We tested the hypotheses that the change in mean length-for-age z score ( LAZ ) for infants provided with @-@ g LNSs/d from ages @ to @ mo would be greater than that for infants receiving no dietary intervention at the same age and that provision of LNSs that did not contain milk would be as good as milk-containing LNSs in promoting linear growth .


We enrolled in a randomized single-blind trial @-mo-old infants who were allocated to @ of @ groups to receive @ , @ , or @ g LNSs/d containing milk powder ; @ or @ g milk-free LNSs/d ; or no supplement until @ mo of age .


The primary outcome was change in LAZ .


Of the @ enrolled infants , @ ( @ % ) died and @ ( @ % ) dropped out during the trial .


The overall reported supplement consumption was @ % of days , with no difference between the groups ( P = @ ) .


The overall mean SD length and LAZ changes were @ @ cm and -@ @ z score units , respectively , which did not differ between the groups ( P = @ for length and P = @ for LAZ ) .


The difference in mean LAZ change in the no-milk LNS group compared with the milk LNS group was -@ ( @ % CI : -@ , @ ; P = @ ) .


Our results do not support the hypothesis that LNS supplementation during infancy and childhood promotes length gain or prevents stunting between @ and @ mo of age in Malawi .


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


Few studies have examined the relation between impulsivity and drug involvement with prison inmates , in spite of their heavy drug use .


Among this small body of work , most studies look at clinically relevant drug dependence , rather than drug use specifically .


N = @ adult inmates ( @ % female , @ % White ) with an average age of @ ( SD = @ ) completed a modified version of the @-item Barratt Impulsiveness Scale ( BIS ) and measures assessing lifetime alcohol , opiate , benzodiazepine , cocaine , cannabis , hallucinogen , and polysubstance use .


Lifetime users also reported the frequency of use for the @days prior to incarceration .


Impulsivity was higher among lifetime users ( versus never users ) of all substances other than cannabis .


Thirty day drug use frequency was only related to impulsivity for opiates and alcohol .


This study extends prior work , by showing that a lifetime history of non-clinical substance use is positively associated with impulsivity among prison inmates .


Implications for drug interventions are considered for this population , which is characterized by high rates of substance use and elevated impulsivity .


Diabetes mellitus ( DM ) accelerates plaque progression despite the use of statin therapy .


The purpose of the present study was to evaluate the determinants of atheroma progression in statin-treated patients with DM .


Coronary atherosclerosis in nonculprit lesions in a vessel undergoing percutaneous coronary intervention ( PCI ) was evaluated using virtual histology intravascular ultrasound .


The study included @ patients with DM who had been taking statin therapy for @ months at the time of PCI .


Twenty-six patients ( @ % ) showed atheroma progression ( progressors ) and the remaining @ patients ( @ % ) showed atheroma regression ( regressors ) after @ months of follow-up .


Fewer progressors than regressors received intensive lipid-lowering therapy with pitavastatin ( @ % vs. @ % , p = @ ) and the frequency of insulin use was higher in progressors ( @ % vs. @ % , p = @ ) .


However , neither of these differences reached statistical significance .


Risk factor control at baseline and at the @-month follow-up did not differ between the @ groups except for serum levels of eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) .


Univariate regression analysis showed that serum EPA ( r = -@ , p = @ ) and DHA ( r = -@ , p = @ ) negatively correlated with atheroma progression .


Multivariate stepwise regression analysis showed that low serum DHA and pravastatin use were significant independent predictors for atheroma progression during statin therapy ( DHA : = -@ , type of statin : = -@ , p = @ ) .


Low serum DHA is associated with progression of coronary atherosclerosis in statin-treated patients with DM .


Superficial venous reflux and varicose veins are common .


The aim of this randomized controlled trial was to assess effectiveness of compression therapy compared with surgery for superficial venous reflux .


@ patients with CEAP class C@-C@ and superficial venous reflux were randomized to receive either conservative treatment ( compression stockings ) ( n = @ ) or surgery ( n = @ ) .


Clinical examination including duplex ultrasound ( DUS ) was performed at entry and @ and @ years after randomization ( compression group ) or surgery ( surgery group ) .


Venous Clinical Severity Score without compression stockings ( VCSS-S ) , Venous Segmental Disease Score ( VSDS ) , Venous Disability Score ( VDS ) , and health-related quality of life ( HRQoL ) were assessed at entry and at the follow-ups .


Data were analysed on an intention-to-treat basis and according to the actual treatment performed .


At @ years , @/@ patients in the surgery group and @/@ patients in the compression group had been operated on .


VCSS-S decreased from @ to @ in the compression group ( p < @ ) and from @ to @ in the surgery group ( p < @ ) .


VSDS decreased from @ to @ in the compression group and from @ to @ in the surgery group ( p < @ ) .


HRQoL did not change in the compression group , but improved significantly in the surgery group .


The surgical elimination of non-complicated superficial venous reflux is an effective treatment when compared with providing compression stockings only .


Minimally invasive procedures , e.g. video-assisted thoracoscopic lobectomy , are less traumatic and thus one may expect a lower level of postoperative pain compared to open procedures .


This assumption is supported by several studies/metaanalyses .


However , confirmation by larger prospective randomised studies is lacking .


In the present study we analysed @ groups of patients with lobectomy for early-stage lung cancer performed by VATS or by antero-lateral thoracotomy .


@ patients with early-stage NSC lung cancer were randomised to VATS lobectomy ( A ) or open resection ( B ) .


Two patients from A were excluded .


The @ groups were equally large ( n = @ ) .


All patients received the same analgetic therapy regime during and after surgery .


We defined the early postoperative period as the first @ days after operation and evaluated the intensity of pain ( assessed by NAS ) and the medication .


Data acquisition was performed until discharge or the @th postoperative day .


@ values for mean NAS were calculated for both groups and each situation ( at rest or under movement ) .


For @ a significant difference resulted in favour of VATS .


In open thoracotomy the postoperative pain level was acceptable ( NAS < @ ) due to our well established pain control management .


Also , @ categories of patients with a very low pain profile were defined : patients with NAS not over @ at any point , patients without any pain ( NAS = @ ) after a certain point or patients discharged without any pain .


The VATS procedure showed a higher proportion of patients in all @ categories : @ in A vs. @ in B had a max .


NAS of @ during the course ; @ vs. @ were free of pain at certain times and @ vs. @ were discharged without pain .


For both groups a painless postoperative course was achieved on day @ ( range , @-@ days for A/@ -@ for B ) .


The medication was adjusted according to intensity .


A difference was seen in favour of VATS for Sufentanil + Ropivacain via PDK and for Piritramid i.v.


Regardless of procedure ( VATS vs. open ) pain control can be achieved with an adequate analgetic regime .


For VATS during the first days a lower amount of medication is required .


The VATS group showed a higher proportion of patients with very low postoperative pain profile : patients with pain score always under @ and patients without pain at certain points before the @th postoperative day or at discharge .


Dipeptidyl peptidase @ ( DPP-@ ) inhibitors have been widely used in type @ diabetes .


An important unanswered question concerns the effect of DPP-@ inhibition on - cell function in patients with autoimmune diabetes .


The objective of the study was to investigate the effects of the DPP-@ inhibitor on - cell function in patients with recent-onset latent autoimmune diabetes in adults ( LADA ) .


This study was an open-label , randomized-controlled study conducted in the Department of Endocrinology at the Second Xiangya Hospital .


Thirty recently diagnosed LADA patients were randomized @:@ to receive insulin therapy with @ mg/d sitagliptin ( group A , n = @ ) or without sitagliptin ( group B , n = @ ) for @ months .


Fasting and @-hour postprandial blood samples were obtained at baseline and after @ , @ , @ , and @ months of treatment to determine blood glucose , glycosylated hemoglobin , and C-peptide levels .


There were no differences in the clinical baseline data between the two groups .


During the @ months of follow-up , there were no significant differences in glucose and glycosylated hemoglobin levels between the two groups .


At @ months , fasting C-peptide ( FCP ) , @-hour postprandial C-peptide ( CP ) , and CP ( CP = @ h CP-FCP ) levels were not different in group A ( P > @ ) compared with baseline , whereas in group B the levels of FCP , @-hour CP and CP were significantly decreased compared with baseline ( P < @ ) .


Levels of @-hour CP were higher in group A than group B at @ months ( P < @ ) .


LADA patients treated with sitagliptin and insulin maintained - cell function by comparison with insulin alone .


Diabetic foot ulcers ( DFUs ) often pose a treatment problem .


Bioengineered skin substitutes have been reported to result in accelerated diabetic wound healing .


The purpose of this clinical trial was to evaluate the efficacy and safety of the autologous fibroblast-hyaluronic acid complex for treating DFUs .


A stratified , randomised , controlled , multicentre study was carried out .


Patients with DFUs were allocated to either a treatment group with grafting of an autologous fibroblast-hyaluronic acid complex or a control group with non-adherent foam dressing .


Except for application of the fibroblast complex , treatment of the study ulcers was identical for patients in both groups .


The maximum follow-up period for each patient was @ weeks .


Complete ulcer healing was achieved in @ % ( @/@ patients ) of the treatment group and @ % ( @/@ patients ) of the control group ( p < @ ) .


The times required for complete healing were @ @ and @ @ days in the treatment and control groups , respectively ( p < @ ) .


No adverse events related to treatment occurred .


These results indicate that autologous fibroblast-hyaluronic acid complex may offer a safe and effective treatment for DFUs .


Gastrointestinal graft-versus-host disease ( GvHD ) is a potentially life-threatening complication after allogeneic stem cell transplantation ( SCT ) .


Since therapeutic options are still limited , a prophylactic approach seems to be warranted .


In this randomised , double-blind-phase III trial , we evaluated the efficacy of budesonide in the prophylaxis of acute intestinal GvHD after SCT .


The trial was registered at https://clinicaltrials.gov , number NCT@ .


The crude incidence of histological or clinical stage @-@ acute intestinal GvHD until day @ observed in @ ( n = @ budesonide , n = @ placebo ) evaluable patients was @ % ( @ % CI @-@ % ) under treatment with budesonide and @ % ( @ % CI @-@ % ) under placebo ( p = @ ) .


Histologic and clinical stage @-@ intestinal GvHD after @ months occurred in @ % ( @ % CI @-@ % ) of patients in the budesonide group and @ % ( CI @-@ % ) in the placebo group ( p = @ ) .


Although budesonide was tolerated well , we observed a trend towards a higher rate of infectious complications in the study group ( @ % versus @ % , p = @ ) .


The cumulative incidences at @ months of intestinal GvHD stage > @ with death as a competing event ( budesonide @ % vs. placebo @ % , p = @ ) and the cumulative incidence of relapse ( budesonide @ % vs. placebo @ % , p = @ ) and non-relapse mortality ( budesonide @ % ( @ % CI @-@ % ) vs. placebo @ % ( @ % CI @-@ % ) , showed no significant difference within the two groups ( p = @ ) .


The trial closed after @ patients were enrolled because of slow accrual .


Within the limits of the final sample size , we were unable to show any benefit for the addition of budesonide to standard GvHD prophylaxis .


Budesonide did not decrease the occurrence of intestinal GvHD in this trial .


These results imply most likely that prophylactic administration of budenoside with pH-modified release in the terminal ileum is not effective .


Oxygen is commonly administered to patients with ST-elevation-myocardial infarction despite previous studies suggesting a possible increase in myocardial injury as a result of coronary vasoconstriction and heightened oxidative stress .


We conducted a multicenter , prospective , randomized , controlled trial comparing oxygen ( @ L/min ) with no supplemental oxygen in patients with ST-elevation-myocardial infarction diagnosed on paramedic @-lead ECG .


Of @ patients randomized , @ patients had confirmed ST-elevation-myocardial infarction and underwent primary end-point analysis .


The primary end point was myocardial infarct size as assessed by cardiac enzymes , troponin I , and creatine kinase .


Secondary end points included recurrent myocardial infarction , cardiac arrhythmia , and myocardial infarct size assessed by cardiac magnetic resonance imaging at @ months .


Mean peak troponin was similar in the oxygen and no oxygen groups ( @ versus @ g/L ; ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


There was a significant increase in mean peak creatine kinase in the oxygen group compared with the no oxygen group ( @ versus @ U/L ; means ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


There was an increase in the rate of recurrent myocardial infarction in the oxygen group compared with the no oxygen group ( @ % versus @ % ; P = @ ) and an increase in frequency of cardiac arrhythmia ( @ % versus @ % ; P = @ ) .


At @ months , the oxygen group had an increase in myocardial infarct size on cardiac magnetic resonance ( n = @ ; @ versus @ g ; P = @ ) .


Supplemental oxygen therapy in patients with ST-elevation-myocardial infarction but without hypoxia may increase early myocardial injury and was associated with larger myocardial infarct size assessed at @ months .


To develop prognostic models for time to @-month remission and time to treatment failure after initiating antiepileptic drug monotherapy for generalised and unclassified epilepsy .


We analysed data from the Standard and New Antiepileptic Drug ( arm B ) study , a randomised trial that compared initiating treatment with lamotrigine , topiramate and valproate in patients diagnosed with generalised or unclassified epilepsy .


Multivariable regression modelling was used to investigate how clinical factors affect the probability of achieving @-month remission and treatment failure .


Significant factors in the multivariable model for time to @-month remission were having a relative with epilepsy , neurological insult , total number of tonic-clonic seizures before randomisation , seizure type and treatment .


Significant factors in the multivariable model for time to treatment failure were treatment history ( antiepileptic drug treatment prior to randomisation ) , EEG result , seizure type and treatment .


The models described within this paper can be used to identify patients most likely to achieve @-month remission and most likely to have treatment failure , aiding individual patient risk stratification and the design and analysis of future epilepsy trials .


The efficacy of lapatinib versus trastuzumab combined with taxanes in the first-line setting of human epidermal growth factor receptor @ ( HER@ ) - positive metastatic breast cancer ( BC ) is unknown .


The MA @ trial compared a combination of first-line anti-HER@ therapy ( lapatinib or trastuzumab ) and taxane therapy for @ weeks , followed by the same anti-HER@ monotherapy until progression .


Stratification was by prior ( neo ) adjuvant anti-HER@ therapy , prior ( neo ) adjuvant taxane , planned taxane , and liver metastases .


The primary end point was intention-to-treat ( ITT ) progression-free survival ( PFS ) , defined as time from random assignment to progression by RECIST ( version @ ) criteria , or death for patients with locally assessed HER@-positive tumors .


The primary test statistic was a stratified log-rank test for noninferiority .


PFS was also assessed for patients with centrally confirmed HER@-positive tumors .


From July @ , @ , to December @ , @ , @ patients were accrued from @ countries , resulting in @ patients with centrally confirmed HER@-positive tumors .


Median follow-up was @ months .


Median ITT PFS was @ months with lapatinib and @ months with trastuzumab .


By ITT analysis , PFS was inferior for lapatinib compared with trastuzumab , with a stratified hazard ratio ( HR ) of @ ( @ % CI , @ to @ ; P = @ ) .


In patients with centrally confirmed HER@-positive tumors , median PFS was @ months with lapatinib and @ months with trastuzumab ( HR , @ ; @ % CI , @ to @ ; P < @ ) .


More grade @ or @ diarrhea and rash were observed with lapatinib ( P < @ ) .


PFS results were supported by the secondary end point of overall survival , with an ITT HR of @ ( @ % CI , @ to @ ; P = @ ) ; in patients with centrally confirmed HER@-positive tumors , the HR was @ ( @ % CI , @ to @ ; P = @ ) .


As first-line therapy for HER@-positive metastatic BC , lapatinib combined with taxane was associated with shorter PFS and more toxicity compared with trastuzumab combined with taxane .


Many studies comparing different intravenous fluid types usually do not use equipotent volumes of three to one crystalloid to colloid ratio in such comparisons .


Conflicting results emanate from such studies .


This study was designed to compare the efficacy of equipotent volumes of colloid and crystalloid-colloid combination in spinal anesthesia-induced hypotension prophylaxis during cesarean section .


A prospective randomized double blinded experimental study carried out in a tertiary hospital in Nigeria .


Pregnant women scheduled for elective cesarean section were prospectively randomized into two groups to receive either @ ml of crystalloid/colloid ( @/@ ml ) combination or @ ml colloid intravenous fluid preload , before spinal anesthesia .


Hemodynamic variables were monitored till the end of surgery .


The results were collated , analyzed , and rational conclusions deduced .


Data collected and analyzed with Statistical Package for Social Sciences ( SPSS ) version @ and rational deductions derived .


In the first @ min , the crystalloid-colloid combination showed better efficacy in hypotension prophylaxis over the colloid only regimen .


In the next @ min ; however , there was no significant difference between both groups in hemodynamic parameters .


Beyond @ min the crystalloid-colloid combination has no advantage over colloid alone in hypotension prophylaxis , as used in this study .


The dorsolateral prefrontal cortex ( DLPFC ) plays an important role in appetite and food intake regulation .


Because previous data revealed that transcranial direct current stimulation ( tDCS ) of the DLPFC reduces food cravings , we hypothesized that repetitive electric stimulation of the right DLPFC would lower food intake behavior in humans .


In a single-blind , code-based , placebo-controlled , counterbalanced , randomized crossover experiment , @ healthy young men with body mass index ( in kg/m ( @ ) ) from @ to @ were examined during @ d of daily tDCS or a sham stimulation .


After tDCS or sham stimulation on the first and the last day of both experimental conditions , participants consumed food ad libitum from a standardized test buffet .


One week of daily anodal tDCS reduced overall caloric intake by @ % in comparison with sham stimulation .


Moreover , repetitive tDCS diminished self-reported appetite scores .


Our study implies that the application of anodal direct currents to the right DLPFC represents a promising option for reducing both caloric intake and appetite in humans .


This trial was registered at the German Clinical Trials Register ( www.germanctr.de ) as DRKS@ .


To compare the effect of a custom-designed yoga program with @ other balance training programs .


Randomized controlled trial .


Research laboratory .


A group of older adults ( N = @ ; mean age , @ @ y ) with a history of falling .


Three different exercise interventions ( Tai Chi , standard balance training , yoga ) were given for @ weeks .


Balance performance was examined during pre - and posttest using field tests , including the @-foot up-and-go test , @-leg stance , functional reach , and usual and maximal walking speed .


The static and dynamic balances were also assessed by postural sway and dynamic posturography , respectively .


Training produced significant improvements in all field tests ( P < @ ) , but group difference and time group interaction were not detected .


For postural sway , significant decreases in the area of the center of pressure with eyes open ( P = @ ) and eyes closed ( P = @ ) were detected after training .


For eyes open , maximum medial-lateral velocity significantly decreased for the sample ( P = @ ) .


For eyes closed , medial-lateral displacement decreased for Tai Chi ( P < @ ) .


For dynamic posturography , significant improvements in overall score ( P = @ ) , time on the test ( P = @ ) , and @ linear measures in lateral ( P = @ ) and anterior-posterior ( P < @ ) directions were seen for the sample .


Yoga was as effective as Tai Chi and standard balance training for improving postural stability and may offer an alternative to more traditional programs .


Routine intracoronary thrombus aspiration before primary percutaneous coronary intervention ( PCI ) in patients with ST-segment elevation myocardial infarction ( STEMI ) has not been proved to reduce short-term mortality .


We evaluated clinical outcomes at @ year after thrombus aspiration .


We randomly assigned @ patients with STEMI to undergo manual thrombus aspiration followed by PCI or to undergo PCI alone , in a registry-based , randomized clinical trial .


The primary end point of all-cause mortality at @ days has been reported previously .


Death from any cause at @ year was a prespecified secondary end point of the trial .


No patients were lost to follow-up .


Death from any cause occurred in @ % of the patients ( @ of @ patients ) in the thrombus-aspiration group , as compared with @ % ( @ of @ ) in the PCI-only group ( hazard ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


Rehospitalization for myocardial infarction at @ year occurred in @ % and @ % of the patients , respectively ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) , and stent thrombosis in @ % and @ % , respectively ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) .


The composite of death from any cause , rehospitalization for myocardial infarction , or stent thrombosis occurred in @ % and @ % of the patients , respectively ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) .


The results were consistent across all the major subgroups , including grade of thrombus burden and coronary flow before PCI .


Routine thrombus aspiration before PCI in patients with STEMI did not reduce the rate of death from any cause or the composite of death from any cause , rehospitalization for myocardial infarction , or stent thrombosis at @ year .


( Funded by the Swedish Research Council and others ; TASTE ClinicalTrials.gov number , NCT@ . )


To evaluate efficacy of efinaconazole topical solution , @ % in onychomycosis patients with early and long-standing disease .


An analysis of @ patients , aged @-@ years , randomized to receive efinaconazole topical solution , @ % or vehicle from two identical multicenter , double-blind , vehicle-controlled @-week studies evaluating safety and efficacy .


The primary end point was complete cure rate ( @ % clinical involvement of target toenail , and both negative potassium hydroxide examination and fungal culture ) at Week @ .