The DCP uses a pragmatic , cluster randomised controlled trial design .


Accredited general practices that are situated within any of the seven Australian Medicare Locals/Divisions of General Practice that have agreed to take part in the study were invited to participate .


Consenting practices will be randomly assigned to one of three treatment groups for approximately @ to @ months : ( a ) control group ( usual care ) ; ( b ) Intervention @ ( which tests improvements that could be made within the current funding model , facilitated through the use of an online chronic disease management network ) ; or ( c ) Intervention @ ( which includes the same components as Intervention @ , as well as altered funding to support voluntary patient registration with their practice , incentive payments and a care facilitator ) .


Adult patients who attend the enrolled practices and have established ( @ month 's duration ) type @ diabetes mellitus or newly diagnosed or established type @ diabetes mellitus are invited to participate .


Multiple outcomes will be studied , including changes in glycosylated haemoglobin ( primary outcome ) , changes in other biochemical and clinical metrics , incidence of diabetes-related complications , quality of life , clinical depression , success of tailored care , patient and practitioner satisfaction , and budget sustainability .


This project responds to a need for robust evidence of the clinical and economic effectiveness of coordinated care for the management of diabetes in the Australian primary care setting .


The outcomes of the study will have implications not only for diabetes management , but also for the management of other chronic diseases , both in Australia and overseas .


To investigate and compare the effects of superelastic nickel-titanium and multistranded stainless steel archwires on pain during the initial phase of orthodontic treatment .


A double-blind two-arm parallel design stratified randomized clinical trial .


A single centre in India between December @ and June @ .


A total of @ participants ( @ male and @ females ; @ years old ) were randomized ( stratified on age , sex and initial crowding ) to superelastic nickel-titanium or multistranded stainless steel archwire groups using a computer-generated allocation sequence .


We compared @-inch superelastic nickel-titanium and @-inch multistranded stainless steel wires in @-inch slot ( Roth prescription ) preadjusted edgewise appliances .


The follow-up period was @ days .


Outcome was assessed with a visual analogue scale at baseline and @ pre-specified follow-up points .


Data was analyzed using mixed-effects model analysis .


One participant was lost to follow up and @ were excluded from the analysis due to bond failure or incomplete questionnaire answers .


Ultimately , @ participants ( @ males and @ females ; @ years old ) were analysed for the final results .


No statistically significant difference was found for overall pain -LSB- F value = @ , degrees of freedom ( df ) = @ ; P = @ -RSB- .


However , compared to multistranded stainless steel wires , pain in subjects with superelastic nickel-titanium archwires was significantly greater at @ h ( t = @ ; P = @ ) , as well as at day @ in the morning ( t = @ , P = @ ) , afternoon ( t = @ , P = @ ) and at bedtime ( t = @ , P = @ ) .


For overall pain , there was no statistically significant difference between the two wires .


However , subjects with superelastic nickel-titanium archwires had a significantly higher pain at peak level .


Neurodevelopmental theories of psychosis highlight the potential benefits of early intervention , prevention , and/or preemption .


How early intervention should take place has not been established , nor whether interventions based on social learning principles can have preemptive effects .


The objective was to test whether a comprehensive psychosocial intervention can significantly alter psychotic symptom trajectories during adolescence-a period of heightened risk for a wide range of psychopathology .


This study was a randomized controlled trial ( RCT ) of Multidimensional Treatment Foster Care ( MTFC ) for delinquent adolescent girls .


Assessment of psychotic symptoms took place at baseline and then @ , @ , @ , and @ months post-baseline using a standardized self-report instrument ( Brief Symptom Inventory ) .


A second source of information about psychotic symptoms was obtained at baseline or @ months , and again at @ months using a structured diagnostic interview ( the Diagnostic Interview Schedule for Children -LSB- DISC -RSB- ) .


Significant benefits for MTFC over treatment as usual for psychosis symptoms were observed over a @-month period .


Findings were replicated across both measures .


Effects were independent of substance use and initial symptom severity and persisted beyond the initial intervention period .


Ameliorating nonclinical psychotic symptoms trajectories beginning in mid-adolescence via a multifaceted psychosocial intervention is possible .


Developmental research on nonclinical psychotic symptoms and their prognostic value should be complemented by more psychosocial intervention research aimed at modifying these symptom trajectories early in their natural history .


Clinical trial registration information-Juvenile Justice Girls Randomized Control Trial : Young Adult Follow-up ; http://clinicaltrials.gov; NCT@ .


INT@ besylate is a potent , nonthiazolidinedione , selective peroxisome proliferator-activated receptor ( PPAR ) modulator ( SPPARM ) designed to improve glucose metabolism while minimizing the side effects of full PPAR agonists .


This placebo-controlled study compared the efficacy and side effects of INT@ besylate versus @ mg pioglitazone HCl in subjects with type @ diabetes ( T@D ) .


This was a @-week randomized , double-blind , placebo - and active-controlled study of @-@ @ mg INT@ versus @ mg pioglitazone or placebo daily in @ subjects with T@D on sulfonylurea or sulfonylurea plus metformin .


The primary efficacy analysis was the comparison of change from baseline to week @ in hemoglobin A@c ( HbA@c ) across treatment groups .


Fluid status was assessed with a prospective scoring system for lower-extremity pitting edema .


INT@ had a steep dose response for efficacy as measured by changes in HbA@c .


After @ weeks ' treatment , the @-mg dose demonstrated minimal efficacy ( HbA@c -@ @ % ) and the @-mg dose demonstrated near-maximal efficacy ( HbA@c -@ @ % ) , which was not statistically different from the efficacy of @ mg pioglitazone ( HbA@c -@ @ % ; P < @ for noninferiority ) .


With the @-mg dose , INT@ provided significant improvements in glycemic control ( HbA@c @ @ ; P < @ vs. placebo ) but with less edema , weight gain , and hemodilution than observed with @ mg pioglitazone .


INT@ demonstrated dose-dependent reductions in HbA@c , equivalent to @ mg pioglitazone , but with less fluid accumulation and weight gain , consistent with its SPPARM design .


HIV-@ vaccine development has advanced slowly due to viral antigenic diversity , poor immunogenicity and recently , safety concerns associated with human adenovirus serotype-@ vectors .


To tackle HIV-@ variation , we designed a unique T-cell immunogen HIVconsv from functionally conserved regions of the HIV-@ proteome , which were presented to the immune system using a heterologous prime-boost combination of plasmid DNA , a non-replicating simian ( chimpanzee ) adenovirus ChAdV-@ and a non-replicating poxvirus , modified vaccinia virus Ankara .


A block-randomized , single-blind , placebo-controlled phase I trial HIV-CORE @ administered for the first time candidate HIV-@ - vaccines or placebo to @ healthy HIV-@ / @-uninfected adults in Oxford , UK and elicited high frequencies of HIV-@-specific T cells capable of inhibiting HIV-@ replication in vitro .


Here , detail safety and tolerability of these vaccines are reported .


Local and systemic reactogenicity data were collected using structured interviews and study-specific diary cards .


Data on all other adverse events were collected using open questions .


Serum neutralizing antibody titres to ChAdV-@ were determined before and after vaccination .


Two volunteers withdrew for vaccine-unrelated reasons .


No vaccine-related serious adverse events or reactions occurred during @ person-months of follow-up .


Local and systemic events after vaccination occurred in @/@ individuals and most were mild ( severity grade @ ) and predominantly transient ( < @ hours ) .


Myalgia and flu-like symptoms were more strongly associated with MVA than ChAdV@ or DNA vectors and more common in vaccine recipients than in placebo .


There were no intercurrent HIV-@ infections during follow-up .


@/@ volunteers had low ChAdV-@-neutralizing titres at baseline and @ increased their titres to over @ with a median ( range ) of @ ( @-@ ) post-vaccination , which is of no safety concern .


These data demonstrate safety and good tolerability of the pSG@.HIVconsv DNA , ChAdV@.HIVconsv and MVA.HIVconsv vaccines and together with their high immunogenicity support their further development towards efficacy studies .


Low levels of health-enhancing physical activity require novel approaches that have the potential to reach broad populations .


Web-based interventions are a popular approach for behaviour change given their wide reach and accessibility .


However , challenges with participant engagement and retention reduce the long-term maintenance of behaviour change .


Web @ features present a new and innovative online environment supporting greater interactivity , with the potential to increase engagement and retention .


In order to understand the applicability of these innovative interventions for the broader population , ` real-world ' interventions implemented under ` everyday conditions ' are required .


The aim of this study is to investigate the difference in physical activity behaviour between individuals using a traditional Web @ website with those using a novel Web @ website .


In this study we will aim to recruit @ participants .


Participants will be recruited from individuals who register with a pre-existing health promotion website that currently provides Web @ features ( http://www@steps.org.au ) .


Eligible participants who provide informed consent will be randomly assigned to one of the two trial conditions : the pre-existing @ Steps website ( with Web @ features ) or the newly developed WALK @ website ( with Web @ features ) .


Primary and secondary outcome measures will be assessed by self-report at baseline , @months and @months , and include : physical activity behaviour , height and weight , Internet self-efficacy , website usability , website usage and quality of life .


Research suggests that people with bipolar disorder may be highly motivated to attain dominance and may over-estimate their social power ( Johnson and Carver , @ ) .


This manic temperament may provide an adaptive advantage in the pursuit of dominance and leadership ( Akiskal and Akiskal , @ ) .


It was hypothesized that people at high risk for bipolar disorder , as defined by the Hypomanic Personality Scale ( HPS ) , would fail to assume a submissive role when it was appropriate to do so .


Participants ( @ undergraduates ) completed an image description task with a confederate .


Participants were randomly assigned to interact with a confederate who assumed one of three nonverbal postures : dominant ( expanded ) , neutral , or submissive ( constricted ) .


Nonverbal dominance behavior was defined as the rate at which participants expanded their body span during the task .


Consistent with hypotheses , an ANOVA indicated an interaction of Mania risk x Dominance condition on body expansion .


Whereas participants with low mania risk ( HPS scores ) adapted complementary behavior in response to the confederate , participants with high mania risk demonstrated a consistently dominant ( expanded ) nonverbal posture .


A major limitation of this study is the use of an analog measure of mania risk in place of clinical diagnoses .


In this experiment , participants at high risk for mania maintained a dominant posture even when submissiveness would have been more appropriate .


It is argued that persistent dominance behavior may play an important role in the interpersonal interactions of individuals at risk for bipolar disorder .


Inadequate designs and conflicting results from previous studies prompted the US Food and Drug Administration to publish guidelines for the design of clinical trials evaluating the effects of orally inhaled and intranasal corticosteroids on the growth of children .


This study conformed to these guidelines to evaluate the effect of triamcinolone acetonide aqueous nasal spray ( TAA-AQ ) on the growth of children with perennial allergic rhinitis ( PAR ) .


This randomized , double-blind , placebo-controlled , parallel-group , multicenter study evaluated the effect of once-daily TAA-AQ ( @ g ) on the growth velocity ( GV ) of children aged @-@ years with PAR by using stadiometry at baseline ( @-@ months ) , during treatment ( @ months ) , and at follow-up ( @ months ) .


Hypothalamus-pituitary-adrenal ( HPA ) axis function was assessed by measuring urinary cortisol levels .


Details of adverse events were recorded .


Of @ subjects screened , @ were randomized , and @ completed the study ( placebo , @ ; TAA-AQ , @ ) .


In the primary analysis ( modified intent-to-treat : placebo , @ ; TAA-AQ , @ ) , least-squares mean GV during treatment was lower in the TAA-AQ group ( @ cm/year ) versus placebo ( @ cm/year ) .


The difference ( -@ cm/year ; @ % confidence interval : -@ to -@ ; P = @ ) , although clinically nonsignificant , was evident within @ months of treatment and stabilized thereafter .


At follow-up , the GV approached baseline ( @ cm/year ) in the TAA-AQ group ( @ cm/year ) and decreased slightly in the placebo group ( @ cm/year vs @ cm/year at baseline ) .


No HPA axis suppression was observed .


By using rigorous Food and Drug Administration-recommended design elements , this study detected a small , statistically significant effect of TAA-AQ on the GV of children with PAR .


Fasting is characterised by profound changes in energy metabolism including progressive loss of body proteins .


The underlying mechanisms are however unknown and we therefore determined the effects of a @-hour-fast on human skeletal muscle protein metabolism and activation of mammalian target of rapamycin ( mTOR ) , a key regulator of cell growth .


Eight healthy male volunteers were studied twice : in the postabsorptive state and following @ hours of fasting .


Regional muscle amino acid kinetics was measured in the forearm using amino acid tracers .


Signaling to protein synthesis and breakdown were assessed in skeletal muscle biopsies obtained during non-insulin and insulin stimulated conditions on both examination days .


Fasting significantly increased forearm net phenylalanine release and tended to decrease phenylalanine rate of disappearance .


mTOR phosphorylation was decreased by @ % following fasting , together with reduced downstream phosphorylation of @EBP@ , ULK@ and rpS@ .


In addition , the insulin stimulated increase in mTOR and rpS@ phosphorylation was significantly reduced after fasting indicating insulin resistance in this part of the signaling pathway .


Autophagy initiation is in part regulated by mTOR through ULK@ and fasting increased expression of the autophagic marker LC@B-II by @ % .


p@ is degraded during autophagy but was increased by @ % during fasting making interpretation of autophagic flux problematic .


MAFbx and MURF@ ubiquitin ligases remained unaltered after fasting indicating no change in protesomal protein degradation .


Our results show that during fasting increased net phenylalanine release in skeletal muscle is associated to reduced mTOR activation and concomitant decreased downstream signaling to cell growth .


To evaluate the efficacy of IV iron supplementation of anemic , critically ill trauma patients .


Multicenter , randomized , single-blind , placebo-controlled trial .


Four trauma ICUs .


Anemic ( hemoglobin < @g/dL ) trauma patients enrolled within @ hours of ICU admission and with an expected ICU length of stay of more than or equal to @ days .


Randomization to iron sucrose @mg IV or placebo thrice weekly for up to @ weeks .


A total of @ patients were enrolled .


Baseline iron markers were consistent with functional iron deficiency : @ patients ( @ % ) were hypoferremic , @ ( @ % ) were hyperferritinemic , and @ ( @ % ) demonstrated iron-deficient erythropoiesis as evidenced by an elevated erythrocyte zinc protoporphyrin concentration .


The median baseline transferrin saturation was @ % ( range , @-@ % ) .


In the subgroup of patients who received all six doses of study drug ( n = @ ) , the serum ferritin concentration increased significantly for the iron as compared with placebo group on both day @ ( @ ng/mL vs @ ng/mL , respectively , p < @ ) and day @ ( @,@ ng/mL vs @ ng/mL , respectively , p < @ ) .


There was no significant difference between groups in transferrin saturation , erythrocyte zinc protoporphyrin concentration , hemoglobin concentration , or packed RBC transfusion requirement .


There was no significant difference between groups in the risk of infection , length of stay , or mortality .


Iron supplementation increased the serum ferritin concentration significantly , but it had no discernible effect on transferrin saturation , iron-deficient erythropoiesis , hemoglobin concentration , or packed RBC transfusion requirement .


Based on these data , routine IV iron supplementation of anemic , critically ill trauma patients can not be recommended ( NCT @ ) .


Allogeneic mesenchymal precursor cells ( MPCs ) injected during left ventricular assist device ( LVAD ) implantation may contribute to myocardial recovery .


This trial explores the safety and efficacy of this strategy .


In this multicenter , double-blind , sham-procedure controlled trial , @ patients were randomized ( @:@ ) to intramyocardial injection of @ million MPCs or medium during LVAD implantation .


The primary safety end point was incidence of infectious myocarditis , myocardial rupture , neoplasm , hypersensitivity reaction , and immune sensitization ( @ days after randomization ) .


Key efficacy end points were functional status and ventricular function while temporarily weaned from LVAD support ( @ days after randomization ) .


Patients were followed up until transplant or @ months after randomization , whichever came first .


Mean age was @ ( @ ) years , mean left ventricular ejection fraction was @ % , and @ % were destination therapy LVADs .


No safety events were observed .


Successful temporary LVAD weaning was achieved in @ % of MPC and @ % of control patients at @ days ( P = @ ) ; the posterior probability that MPCs increased the likelihood of successful weaning was @ % .


At @ days , @ deaths ( @ % ) occurred in control patients , and none occurred in MPC patients .


Mean left ventricular ejection fraction after successful wean was @ % ( MPC = @ ) and @ % ( control = @ ; P = @ ) .


At @ months , @ % of MPC patients and @ % of control patients were successfully temporarily weaned from LVAD support ( P = @ ) , and @ deaths ( @ % ) occurred in MPC patients .


Donor-specific HLA sensitization developed in @ MPC and @ control patients and resolved by @ months .


In this preliminary trial , administration of MPCs appeared to be safe , and there was a potential signal of efficacy .


Future studies will evaluate the potential for higher or additional doses to enhance the ability to wean LVAD recipients off support .


Efforts to reduce disparities in recurrent stroke among Black and Latino stroke survivors have met with limited success .


We aimed to determine the effect of peer education on secondary stroke prevention among predominantly minority stroke survivors .


Between @ and @ , we enrolled @ stroke or transient ischemic attack survivors from diverse , low-income communities in New York City into a @-arm randomized clinical trial that compared a @ week ( @ session/week ) , peer-led , community-based , stroke prevention self-management group workshop ( N = @ ) to a wait-list control group ( N = @ ) .


The primary outcome was the proportion with a composite of controlled blood pressure ( < @/@ mm Hg ) , low-density lipoprotein cholesterol < @ mg/dL , and use of antithrombotic medications at @ months .


Secondary outcomes included control of the individual stroke risk factors .


All analyses were by intent-to-treat .


There was no difference in the proportion of intervention and control group participants achieving the composite outcome ( @ % versus @ % ; P = @ ) .


The proportion with controlled blood pressure at @ months was greater in the intervention group than in the control group ( @ % versus @ % ; P = @ ) .


This corresponded to a greater change in systolic blood pressure in the intervention versus control group ( -@ SD , @ mm Hg versus +@ SD , @ mm Hg ; P = @ ) .


There were no group differences in the control of cholesterol or use of antithrombotics .


A low-cost peer education self-management workshop modestly improved blood pressure , but not low-density lipoprotein cholesterol or antithrombotic use , among stroke and transient ischemic attack survivors from vulnerable , predominantly minority urban communities .


Despite @ years of clinical research , we still do not know the optimal dose of intrathecal morphine ( ITM ) when used alone .


A safety investigation and comparison of the analgesic efficacy of ITM @ mg , @ mg , and @ mg in patients undergoing major abdominal cancer surgery .


A randomized , double-blind trial .


Academic medical center .


Ninety patients were randomly assigned to receive morphine intrathecally either @ mg ( Group I , ITM @ mg , n = @ ) , @ mg ( Group II , ITM @ mg , n = @ ) , or @ mg ( Group III , ITM @ mg , n = @ ) dissolved in @ mL physiological saline before general anesthesia .


Assessment parameters included hemodynamics , respiratory rate , peripheral arterial oxygenation , sedation score , pain severity , time of first analgesic request , total analgesic consumption , and side effects in the first @ hours .


The mean time to first request for rescue analgesia was significantly prolonged in Group II ( @ @ hours , P < @ ) and Group III ( @ @ h , P < @ ) , compared with Group I ( @ @ hours ) .


The mean tramadol consumption dose was significantly reduced in Group II ( @ @ mg , P < @ ) and Group III ( @ @ mg , P < @ ) compared with Group I ( @ @ mg ) .


Patients received @ mg ITM showed lower VAS scores in the first @ h postoperative ( P < @ ) compared with Group I and Group II .


No significant differences were observed in the mean systolic and diastolic blood pressure values , respiratory rate , and peripheral arterial oxygen saturation between groups .


Lower mean heart rate values were observed in Group III patients at @ hours ( P < @ ) and @ hours ( P < @ ) postoperative compared with Group I and Group II patients .


Six patients ( @ % ) in Group II and @ ( @ % ) in Group III exhibited pruritus compared with @ patients ( @ % ) in Group I ( P < @ ) .


No intergroup statistical differences were observed for other studied side effects .


This study is limited by its small sample size .


One mg ITM provided superior analgesia for @ hours postoperative compared with @ mg and @ mg ITM with a nonsignificant difference in the incidence of side effects .


Further studies of larger sample size are recommended to confirm these findings .


To study the efficacy of Huai Qi Huang granules in the treatment of childhood primary nephrotic syndrome .


Between July @ and December @ , patients who were admitted and diagnosed for the first time as childhood primary nephrotic syndrome were randomized into a treatment group ( Huai Qi Huang granules plus glucocorticoid ; n = @ ) and a control group ( glucocorticoid alone ; n = @ ) for a prospective study .


The two groups were compared for regression time of edema , time to urinary protein clearance , relapse rate , incidence of infection , dosage of glucocorticoid , and humoral and cellular immunological indicators .


There were no significant differences in regression time of edema , time to urinary protein clearance , and relapse rate between the treatment and control groups ( P > @ ) .


The treatment group had significantly lower incidence of infection and daily dose of glucocorticoid ( at month @ ) than the control group ( P < @ ) .


Humoral and cellular immunological indicators showed no significant differences between the two groups ( P > @ ) .


No Huai Qi Huang-related adverse events were observed in this study .


Huai Qi Huang granules treatment can reduce the dose of glucocorticoid and the incidence of infection in children with primary nephrotic syndrome and has a favourable safety .


Bowel cleansing is generally regarded as time-consuming and unpleasant among patients .


Patients commonly state that bowel preparation provokes more discomfort than the actual colonoscopic examination .


The purpose of this study was to compare two regimens of sodium phosphate ( NaP ) tablets versus polyethylene glycol ( PEG ) solution for bowel preparation in healthy Korean adults .


This was a single center , prospective , open-label , investigator-blinded , randomized , controlled-pilot study .


A total of @ healthy Korean subjects were randomly assigned to two groups ( NaP vs. PEG ) .


Efficacy , safety , and patient-related outcomes , as well as procedural parameters , were evaluated .


Although there were no significant differences in total Ottawa bowel quality score , fluid scores and the rate of adequate bowel preparation were significantly better in the NaP group than the PEG group .


Additionally , the NaP group showed better results regarding patient tolerance , satisfaction , preference , and rate of adverse events than the PEG group .


Significant fluctuations in specific serum electrolytes were common and of a greater magnitude in the NaP group than the PEG group .


However , these abnormalities were transient and did not result in serious complications and side effects .


In this study , NaP tablets were shown to be an effective , well-tolerated , and acceptable regimen for bowel preparation .


Also , our study suggests that NaP tablets may be safe and can be used as a bowel cleansing agent in healthy adults undergoing elective colonoscopy .


Further multicenter , large scale studies are needed to confirm these findings .


Nepal is on track to achieve MDG @ but there is a huge sub-national disparity with existing high maternal mortality in western and hilly regions .


The national priority is to reduce this disparity to achieve the goal at sub-national level .


Evidences from developing countries show that increasing utilization of skilled attendant at birth is an important indicator for reducing maternal death .


Further , there is a very low utilization during childbirth in western and hilly regions of Nepal which clearly depicts the barriers in utilization of skilled birth attendants .


So , there is a need to overcome the identified barriers to increase the utilization thereby decreasing the maternal mortality .


The hypothesis of this study is that through a package of interventions the utilization of skilled birth attendants will be increased and hence improve maternal health in Nepal .


This study involves a cluster randomized controlled trial involving approximately @ pregnant women in @ clusters .


The @ intervention clusters will receive the following interventions : i ) mobilization of family support for pregnant women to reach the health facility , ii ) availability of emergency funds for institutional childbirth , iii ) availability of transport options to reach a health facility for childbirth , iv ) training to health workers on communication skills , v ) security provisions for SBAs to reach services @/@ through community mobilization ; @ control clusters will not receive the intervention package .


The final evaluation of the intervention is planned to be completed by October @ .


Primary study output of this study is utilization of SBA services .


Secondary study outputs measure the uptake of antenatal care , post natal checkup for mother and baby , availability of transportation for childbirth , operation of emergency fund , improved reception of women at health services , and improved physical security of SBAs .


The intervention package is designed to increase the utilization of skilled birth attendants by overcoming the barriers related to awareness , finance , transport , security etc. .


If proven effective , the Ministry of Health has committed to scale up the intervention package throughout the country .


Progressive midlife weight gain is associated with multiple adverse health outcomes and may represent an early manifestation of insulin resistance in a distinct subset of women .


Emerging data implicate hyperinsulinema as a proximate cause of weight gain and support strategies that attenuate insulin secretion .


To assess a previously reported novel hypocaloric carbohydrate modified diet alone ( D ) , and in combination with metformin ( M ) and metformin plus low-dose rosiglitazone ( MR ) , in diverse women with midlife weight gain ( defined as > @lbs since the twenties ) , normal glucose tolerance , and hyperinsulinemia .


@ women , mean age @ , BMI @ kg/m@ , @ % white , @ % black , @ % Hispanic , at @ university medical centers .


A dietary intervention designed to reduce insulin excursions was implemented in @ weekly nutritional group workshops prior to randomization .


Change in @-month fasting insulin .


Pre-specified secondary outcomes were changes in body weight , HOMA-IR , metabolic syndrome ( MS ) measures , leptin , and adiponectin .


Six-month fasting insulin declined significantly in the M group : @ to @ U/ml , p = @ .


Mean @-month weight decreased significantly and comparably in D , M , and MR groups : @ , @ , and @ % ( p 's @ , @ , and @ ) .


HOMA-IR decreased in M and MR groups ( @ to @ and @ to @ , p 's = @ , @ ) .


Additional improvement in MS measures included reduced waist circumference in D and MR groups and increased HDL in the D and M groups .


Notably , mean fasting leptin did not decline in a subset of subjects with weight loss ( @ ng/ml to @ ng/ml , p = @ .


Adiponectin increased significantly in the MR group ( @ to @ , p < @ ) Study medications were well tolerated .


These findings suggest that EMPOWIR 's easily implemented dietary interventions , alone and in combination with pharmacotherapies that target hyperinsulinemia , merit additional investigation in larger , long-term studies .


Virtual reality ( VR ) is not commonly used in clinical rehabilitation , and commercial VR gaming systems may have mixed effects in patients with stroke .


Therefore , we developed RehabMaster , a task-specific interactive game-based VR system for post-stroke rehabilitation of the upper extremities , and assessed its usability and clinical efficacy .


A participatory design and usability tests were carried out for development of RehabMaster with representative user groups .


Two clinical trials were then performed .


The first was an observational study in which seven patients with chronic stroke received @ minutes of RehabMaster intervention per day for two weeks .


The second was a randomised controlled trial of @ patients with acute or subacute stroke who received @ sessions of conventional occupational therapy only ( OT-only group ) or conventional occupational therapy plus @ minutes of RehabMaster intervention ( RehabMaster + OT group ) .


The Fugl-Meyer Assessment score ( FMA ) , modified Barthel Index ( MBI ) , adverse effects , and drop-out rate were recorded .


The requirements of a VR system for stroke rehabilitation were established and incorporated into RehabMaster .


The reported advantages from the usability tests were improved attention , the immersive flow experience , and individualised intervention .


The first clinical trial showed that the RehabMaster intervention improved the FMA ( P = @ ) and MBI ( P = @ ) across evaluation times .


The second trial revealed that the addition of RehabMaster intervention tended to enhance the improvement in the FMA ( P = @ ) but did not affect the improvement in the MBI .


One patient with chronic stroke left the trial , and no adverse effects were reported .


The RehabMaster is a feasible and safe VR system for enhancing upper extremity function in patients with stroke .


The volume of a fibroid uterus before performing hysterectomy is typically estimated through bimanual examination and confirmed by ultrasonography .


This study compares estimated volumes by bimanual examination and ultrasound examination with MRI and actual volumes obtained from histopathology , as gold standards .


We used data from a previous prospective randomized multi-center trial that compared hysterectomy and uterine artery embolization ( UAE ) for the treatment of symptomatic fibroids .


All patients underwent bimanual vaginal examination and pelvic ultrasonography .


Those women randomized to UAE received a pelvic MRI .


For women randomized to hysterectomy , the exact uterine volume was based on histopathologic examination .


We compared the calculated volumes based on ultrasound parameters and estimated volume based on bimanual examination with either the calculated volumes of the pelvic MRI parameters or the calculated volume based on the exact weight during histological examinations .


Our study demonstrated poor agreement between ultrasound and bimanual examination compared with exact volume during histopathologic examination and MRI-based volume .


The agreement within the patient group with uterine volume > @ g and > @ g was fair to good .


For those women with a uterine volume between @ and @ g , the agreement was poor when comparing bimanual estimates with volume obtained from MRI or histolopathologic examination .


Within this volume group , the agreement on uterine volume between ultrasound and MRI or histopathologic examination was fair .


Our study shows that uterine volume as estimated by ultrasound and bimanual examination can be used for small or large uteri .


For uteri with an intermediate volume , bimanual examination and ultrasound are less reliable .


To test the hypothesis that the administration of antithrombin concentrate improves disseminated intravascular coagulation ( DIC ) , resulting in recovery from DIC and better outcomes in patients with sepsis , we conducted a prospective , randomized controlled multicenter trial at @ critical care centers in tertiary care hospitals .


We enrolled @ DIC patients with sepsis and antithrombin levels of @ to @ % in this study .


The participating patients were randomly assigned to an antithrombin arm receiving antithrombin at a dose of @IU/kg per day for three days or a control arm treated with no intervention .


The primary efficacy end point was recovery from DIC on day @ .


The analysis was conducted with an intention-to-treat approach .


DIC was diagnosed according to the Japanese Association for Acute Medicine ( JAAM ) scoring system .


The systemic inflammatory response syndrome ( SIRS ) score , platelet count and global markers of coagulation and fibrinolysis were measured on day @ and day @ .


Antithrombin treatment resulted in significantly decreased DIC scores and better recovery rates from DIC compared with those observed in the control group on day @ .


The incidence of minor bleeding complications did not increase , and no major bleeding related to antithrombin treatment was observed .


The platelet count significantly increased ; however , antithrombin did not influence the sequential organ failure assessment ( SOFA ) score or markers of coagulation and fibrinolysis on day @ .


Moderate doses of antithrombin improve DIC scores , thereby increasing the recovery rate from DIC without any risk of bleeding in DIC patients with sepsis .


To investigate the effect of virtual reality ( VR ) rehabilitation on upper extremity motor performance of patients with early stroke .


Pilot randomized controlled trial .


Rehabilitation wards .


Twenty three adults with stroke ( mean age ( SD ) = @ ( @ ) years and mean time since stroke ( SD ) = @ ( @ ) days ) .


Participants were randomly assigned to VR group ( n = @ ) or control group ( n = @ ) .


VR group received nine @ minutes upper extremity VR therapy in standing ( five weekdays in two weeks ) plus conventional therapy , which included physical and occupational therapy .


Control group received only conventional therapy , which was comparable to total training time received by VR group ( mean training hours ( SD ) : VR = @ ( @ ) ; control = @ ( @ ) ) .


The main outcome measure was the Fugl-Meyer Assessment ( FMA ) .


Secondary outcomes included Action Research Arm Test , Motor Activity Log and Functional Independence Measure .


Results were taken at baseline , post intervention and @-month post intervention .


Participants ' feedback and adverse effects were recorded .


All participants improved in FMA scores ( mean change ( SD ) = @ ( @ ) , P < @ ) .


These effects were sustained at one month after intervention ( mean ( SD ) change from baseline = @ ( @ ) , P < @ ) .


All other outcome measures showed similar patterns .


There were no significant differences in improvement between both groups .


Majority of the participants found VR training useful and enjoyable , with no serious adverse effects reported .


Although additional VR training was not superior to conventional therapy alone , this study demonstrates the feasibility of VR training in early stroke .


n-@ fatty acids inhibit neuronal excitability and reduce seizures in animal models .


High-dose fish oil has been explored in two randomised trials in drug resistant epilepsy with negative results .


We performed a phase II randomised controlled crossover trial of low-dose and high-dose fish oil in participants with drug resistant epilepsy to explore whether low-dose or high-dose fish oil reduces seizures or improves cardiovascular health .


Randomised placebo-controlled trial of low-dose and high-dose fish oil versus placebo ( corn oil , linoleic acid ) in @ participants with drug resistant epilepsy .


A three-period crossover design was utilised lasting @weeks , with three @-week treatment periods and two @-week washout periods .


All participants were randomised in double-blind fashion to receive placebo , high dose or low dose in different sequences .


The primary outcome was per cent change in total seizure frequency .


Low-dose fish oil ( @ capsules/day , @mg eicosapentaenoic acid + docosahexaenoic acid ) was associated with a @ % reduction in seizure frequency compared with placebo .


Low-dose fish oil was also associated with a mild but significant reduction in blood pressure .


High-dose fish oil was no different than placebo in reducing seizures or improving cardiac risk factors .


In this phase II randomised crossover trial , low-dose fish oil was effective in reducing seizures compared with placebo .


The magnitude of improvement is similar to that of recent antiepileptic drug trials in drug resistant epilepsy ( DRE ) .


The results indicate that low-dose fish oil may reduce seizures and improve the health of people with epilepsy .


These findings justify a large multicentre randomised trial of low-dose fish oil ( n-@ fatty acids < @mg/day ) in drug resistant epilepsy .


To assess the patency of the pedicled right internal thoracic artery with an anteroaortic course and compare it to the patency of the left internal thoracic artery , in anastomosis to the left anterior descending artery in coronary artery bypass grafting by using coronary CT angiography at @ months postoperatively .


Between December @ and December @ , @ patients were selected to undergo a prospective coronary artery bypass grafting procedure without cardiopulmonary bypass .


The patients were randomly divided by a computer-generated list into Group-@ ( G-@ ) and Group-@ ( G-@ ) , comprising @ patients each , the technique used was known at the beginning of the surgery .


In G-@ , coronary artery bypass grafting was performed using the left internal thoracic artery for the left anterior descending and the free right internal thoracic artery for the circumflex , and in G-@ , coronary artery bypass grafting was performed using the right internal thoracic artery pedicled to the left anterior descending and the left internal thoracic artery pedicled to the circumflex territory .


The groups were similar with regard to the preoperative clinical data .


A male predominance of @ % and @ % was observed in G-@ and G-@ , respectively .


Five patients migrated from G-@ to G-@ because of atheromatous disease in the ascending aorta .


The average number of distal anastomoses was @ ( SD = @ ) in G-@ and @ ( SD = @ ) in G-@ .


Coronary CT angiography in @ re-evaluated patients showed that all ITAs , right or left , used in situ for the left anterior descending were patent .


There were no deaths in either group .


Coronary artery bypass grafting surgery involving anastomosis of the anteroaortic right internal thoracic artery to the left anterior descending artery has an outcome similar to that obtained using the left internal thoracic artery for the same coronary site .


Dual-energy CT technology enables acquisition of virtual unenhanced ( VUE ) images from contrast-enhanced scans .


To assess the feasibility of coronary artery calcium ( CAC ) scoring on VUE images derived from fast kVp-switching dual-energy coronary CT angiography .


Twenty-seven patients underwent true noncontrast CAC-scoring CT followed by routine single-energy ( @-kVp ) and fast kVp-switching dual-energy coronary CT angiography , in a random acquisition order on the same day .


We calculated the CAC scores on true noncontrast and VUE images .


The image noises and the signal-to-noise and contrast-to-noise ratios of the aorta and coronary arteries were measured on both the single-energy coronary CT angiography images and dual-energy coronary CT angiography images ( @ keV virtual monochromatic spectral images ) .


The Pearson correlation coefficient test and paired t test were used for statistical analysis .


Excellent correlation was observed between the CAC scores on the true noncontrast and those on the VUE images ( r = @ ; P < @ ) .


Compared with single-energy coronary CT angiography , dual-energy coronary CT angiography showed significantly reduced image noise and increased signal-to-noise and contrast-to-noise ratios in all regions ( all P < @ ) .


The effective dose of dual-energy coronary CT angiography ( @ @ mSv ) was significantly lower than that of true noncontrast CAC-scoring CT plus single-energy coronary CT angiography ( @ @ mSv ; P < @ ) .


Excellent correlation was observed between the CAC scores on the VUE images and true noncontrast images .


Thus , fast kVp-switching dual-energy coronary CT angiography could allow prediction of the true CAC scores , potentially reducing the total radiation exposure and image acquisition time by obviating the need for true noncontrast CAC-scoring CT. .


To evaluate the efficacy of tamsulosin therapy in reducing ureteral double-J stent morbidity by evaluating USSQ , IPSS , QOL and VAS ( primary objective ) and to evaluate the morbidity and or complication ( s ) associated with indwelling double-J ureteral stent ( s ) and to evaluate the safety of tamsulosin therapy for `` morbidity associated with double-J stents '' by evaluating its tolerability , side effects and adverse events if any ( secondary objective ) as per protocol .


After institutional review board approval , @ consecutive patients with a double-J ureteral stent inserted after percutaneous nephrolithotomy or ureteroscopic stone treatment were randomly assigned to receive tamsulosin @ mg , or a placebo for @ weeks .


The validated USSQ , VAS and IPSS were completed before stent insertion , at @ days and @ weeks after stent insertion and at @ weeks after stent removal .


Data were statistically analyzed for efficacy and tolerability of one drug over the other using Wilcoxon signed-rank test , Mann-Whitney test and Student 's t test .


Patients receiving tamsulosin compared with the placebo showed significant decrease in urinary index score , pain index score , work performance score , VAS score at loin area , VAS score at flank , VAS score at suprapubic area , average VAS score , need for antibiotics , number of hospital visits ( P < @ ) at the end of fourth weeks .


Decrease in values were also observed in IPSS score , general health score , quality of sex score and IPSS-quality of life ( QOL ) score in patients taking tamsulosin but , however , the decrease was not significant .


No patients discontinued medication because of side effects .


We conclude that ureteral stenting using double-J stents with concomitant tamsulosin therapy was generally well tolerated , safe , effective and significantly beneficial in reducing stent morbidity in the majority of our patients .


We advocate the routine use of concomitant tamsulosin therapy in eligible patients undergoing ureteral stenting in order to minimize stent morbidity .


Parents of children with special needs are vigilant as their child may have difficulty independently escaping a burning home .


The purpose of this study was to evaluate if providing home fire safety information via a digital video disc ( DVD ) increases families ' knowledge , behavior and ability regarding home fire safety .


A school based classroom intervention ( using a home fire safety DVD ) was provided to parents ( n = @ ) of children with and without special needs to improve home fire safety knowledge , behavior and ability .


In addition , parents seen at the Kentucky Commission for Children with Special Health Care Needs clinics ( n = @ ) received the same intervention in cohorts of @-@ children .


For both groups , knowledge , and behavior were measured before and after intervention .


Repeated measures ANOVA were used to test for differences between groups and over time .


Significance was set at p < @ .


No difference in scores between pre - and post-test scores existed between groups ( with special needs vs. without special needs , or classroom vs. individualized instruction ) .


However , some differences were noted for some individual survey questions during post-hoc comparisons .


Having a smoke alarm in the home ( @ % vs. @ % , p = @ ) and having a smoke alarm outside of where everyone sleeps ( @ % vs. @ % , p = @ ) increased over time and was retained .


Having a fire escape plan increased at post intervention ( @ % vs. @ % , p = @ ) , but returned to pre levels at follow-up ( @ % ) .


Perceived knowledge ( @ vs. @ , p < @ ) and ability ( @ vs. @ , p = @ ) increased over time .


Parents of children with special needs had a significant increase in knowledge and behavior over those parents of children without special needs .


They also perceived having a high fire safety ability .


Many of the post-test questions/behaviors ( e.g. , capable of exiting home during a fire , etc. ) were reported at @ % .


The intervention was well received , but may not necessarily be needed .


Focus for home fire safety may need to look at younger children and smaller families .


Parents of special needs children may have had frequent interaction with health care professionals .


To compare pain response outcomes for patients with spinal bone metastases treated with resistance training of the spinal musculature versus passive physical therapy during radiotherapy ( RT ) .


In this randomized trial , @ consecutive patients were treated from September @ until March @ within one of the two groups : resistance training ( Arm A ) or passive physical therapy ( Arm B ) with thirty patients in each group during RT. .


The course of pain according to visual analog scale ( VAS ) , concurrent medication , and oral morphine equivalent dose ( OMED ) were assessed at baseline , three months , and six months after RT. .


Pain response was determined using International Bone Consensus response definitions .


The course of VAS in the intervention group ( Arm A ) was significantly lower both during and after RT ( AUC , p < @ ) .


The use of analgetic medication showed the same result , with significantly fewer analgetics being necessary both during and after RT in arm A ( p < @ ) .


In the course of time , the OMED decreased in arm A , but increased in arm B.


After @ month , @ % of patients in arm A , and @ % in arm B were responders ( p = @ ) .


Our trial demonstrated that guided isometric resistance training of the paravertebral muscles can improve pain relief over a @-months period in patients with stable spinal metastases .


Importantly , the intervention was able to reduce OMED as well as concomitant pain medication .


The trial is registered in Clinical trial identifier NCT @ ( http://www.clinicaltrials.gov/ ) since @nd of August @ .


Prostate cancer is a major public health issue .


Its incidence is rising , especially in Nigeria .


Prompt diagnosis is necessary by histology .


Transperineal and transrectal approaches to prostate biopsy are well-documented .


Both methods are fraught with complications though , most times minor .


Studies carried out to compare both methods were carried out mainly on Caucasians , generating conflicting results .


This study aims to compare the complication rates and tissue yield of these two methods in Nigerian men .


Seventy-five patients completed the study .


Forty-five patients had transperineal prostate biopsy ( TPbx ) , while @ patients had transrectal prostate biopsy .


Pain perception for all patients was determined by visual analog scale ; whereas the complications were ascertained by a validated purpose designed questionnaire administered on the @ th and @ th day post operatively .


The risk of rectal bleeding was higher for transrectal prostate biopsy compared to transperineal ( Odds ratio : @ ; @ % confidence interval ( CI ) : @-@ @ ; P = @ ) .


TPbx was more painful than transrectal ( P < @ ; df : @ ; t : @ ; @ % CI of difference in mean : -@ - -LSB- -@ -RSB- ) .


There was no statistical difference between transperineal and transrectal prostate biopsy in hemospermia , fever , prostatic abscess , urethral bleeding , acute retention and tissue yield .


TPbx is more painful than transrectal prostate biopsy though with a significantly reduced risk of rectal bleeding .


There appears to be no significant difference with respect to risk of fever , urethral bleeding , hematospermia , prostatic abscess and acute retention .


Both routes provided sufficient prostate tissue for histology .


To document the rate and outcome of trastuzumab-associated cardiac dysfunction in patients following @ or @ years of adjuvant therapy .


The Herceptin Adjuvant ( HERA ) trial is a three-arm , randomized trial comparing @ years or @ year of trastuzumab with observation in @,@ patients with human epidermal growth factor receptor @ ( HER@ ) - positive early-stage breast cancer .


Cardiac function was closely monitored .


Eligible patients had left ventricular ejection fraction ( LVEF ) @ % at study entry following neoadjuvant chemotherapy with or without radiotherapy .


This @-year median follow-up analysis considered patients randomly assigned to @ years or @ year of trastuzumab or observation .


The as-treated safety population for @ years of trastuzumab ( n = @,@ ) , @ year of trastuzumab ( n = @,@ ) , and observation ( n = @,@ ) is reported .


Cardiac adverse events leading to discontinuation of trastuzumab occurred in @ % of patients in the @-year arm and @ % of patients in the @-year arm .


Cardiac death , severe congestive heart failure ( CHF ) , and confirmed significant LVEF decrease remained low in all three arms .


The incidence of severe CHF ( @ % , @ % , and @ % , respectively ) and confirmed significant LVEF decrease ( @ % , @ % , and @ % , respectively ) was significantly higher in the @-year and @-year trastuzumab arms compared with the observation arm .


Severe CHF was the same for @-year and @-year trastuzumab .


Of patients with confirmed LVEF decrease receiving @-year trastuzumab , @ % reached acute recovery .


Long-term assessment at @-year median follow-up confirms the low incidence of cardiac events for trastuzumab given sequentially after chemotherapy and radiotherapy , and cardiac events were reversible in the vast majority of patients .


Combination of fluoropyrimidines and a platinum derivative are currently standards for systemic chemotherapy in advanced adenocarcinoma of the stomach and gastroesophageal junction ( GEJ ) .


Nevertheless , individual likelihood for response to these therapeutic regimes remains uncertain .


Even more , no predictive markers are available to determine which patients may benefit more from oxaliplatin versus cisplatin or vice versa .


The new invasion and stem cell markers VEGFR-@ and CXCR@ have been linked prognostically with more aggressive esophagogastric cancer types .


Thus , we aimed to assess correlations of VEGFR-@ and CXCR@ expression levels with clinical outcome in a randomized phase III study of patients with oxaliplatin/leucovorin/@-FU ( FLO ) versus cisplatin/leucovorin/@-FU ( FLP ) .


The patients data examined in this study ( n = @ ) were from the collective of the FLO vs. FLP phase III AIO trial .


Tumour tissues were stained via immunohistochemistry for VEGFR-@ and CXCR@ expression and results were evaluated by two independent , blinded investigators.Outcome parameter : Survival analysis was calculated for patients receiving FLO vs. FLP in relation to VEGFR-@ and CXCR@ expression .


@ % and @ % of the examined tumour tissues showed strong positive expression of VEGFR-@ and CXCR@ respectively .


No superiority of each regime was detected in terms of overall survival ( OS ) in the whole population .


Patients with strong expression of CXCR@ on their tumour tissues profited more in terms of OS under the treatment of FLP ( mOS : @ vs @ months , p = @ respectively ) .


Patients with negative VEGFR-@ and CXCR@ expression had a trend to live longer when FLO regime was applied ( mOS : @ vs. @ months , p = @ and @ vs. @ months , p = @ respectively ) .


In an exploratory analysis of patients older than @ years at diagnosis , we observed a significant benefit in overall survival for VEGFR-@ and CXCR@-positive patients when treated with FLP ( p = @ , p = @ respectively ) .


CXCR@ positive patients profited in terms of OS from FLP , whereas FLO proved to be more effective in CXCR@ and VEGFR-@ negative patients .


Our results suggest , despite the limited size of the study , a predictive value of these biomarkers concerning chemotherapy with FLP or FLO in advanced esophagogastric cancer .


The aim of this study was to investigate the significance of the combined use of BMI and AEC in reducing the radiation dose of CT volume scans of the lumbar spine .


A prospective study was performed to continuously collect data from @ patients ( age range from @ to @ years , male versus female @/@ ) whose BMIs were less than @ kg/m <formula> ^ -LCB- @ -RCB- </formula> ( group A ) and @ patients ( age range from @ to @ years , male versus female @/@ ) whose BMIs were equal to or more than @ kg/m <formula> ^ -LCB- @ -RCB- </formula> ( group B ) .


The @ patients in each group were randomly divided into @ subgroups with each subgroup having lower radiation dose from subgroup @ to @ .


All the patients were performed lumbar spiral CT scans ( GE LightSpeed VCT @-slice scanner ) and the scan parameters were different in different subgroups .


Volume CT dose index ( CTDIvol ) was recorded .


The qualities of the images were graded .


The one-way ANOVA and Kruskal-Wallis test were done .


Both in group A and B , there were significant differences in CTDIvol among the @ subgroups ( P < @ ) .


The quality of the images in the @ subgroups of group A did n't show statistical difference .


The standard deviation ( SD ) and signal to noise ratio ( SNR ) values of the L@-@ psoas major muscles in subgroup @ of group B was statistical different from the other @ subgroups ( P < @ ) .


Use of BMI combined with AEC reduces radiation dosage , without compromising the image quality .


For patients in group A and group B , parameters of subgroup @ and subgroup @ may respectively be applied for lower dose CT scanning .


To evaluate the distribution and extent of myocardial fibrosis identified by either contrast-enhanced Look-Locker or late gadolinium enhancement magnetic resonance imaging ( LGE MRI ) and their relationships between ventricular tachyarrhythmia or risk factors in apical hypertrophic cardiomyopathy ( APH ) .


Twenty-five APH patients were examined using a @ T or @ T instrument .


We used MRI to evaluate myocardial T@ values and scar .


We compared the myocardial fibrosis assessed by contrast-enhanced Look-Locker or LGE MRI with ventricular tachyarrhythmia or risk factors for hypertrophic cardiomyopathy .


Myocardial scar was present in @ of the @ patients with APH .


Myocardial scar was distributed predominantly in the apical myocardium ( P < @ ) , whereas myocardial T@ values did not differ between the apical , midventricular , and basal septum .


The extent of myocardial scar according to @-segment model and ejection fraction were related to ventricular tachyarrhythmia or risk factors in APH ( P < @ for both ) .


The myocardial T@ value was not associated with the tachyarrhythmia or risk factors .


In APH , the extent of myocardial scar on LGE MRI is associated with ventricular tachyarrhythmia and risk factors .


Quantification of the myocardial T@ value is not necessary for its risk stratification .


To compare the difference in clinical efficacy on children attention deficit hyperactivity disorder ( ADHD ) between the combined therapy of scalp acupuncture and EGG biofeedback and the simple EEG biofeedback therapy so as to search the better therapeutic method for ADHD .


One hundred patients were randomized into an observation group and a control group , @ cases in each one .


In the control group , the simple EEG biofeedback therapy was adopted .


In the observation group , on the basis of biofeedback therapy , scalp acupuncture was added and applied to Dingzhongxian ( MS @ ) , Dingpangyixian ( MS @ ) , Baihui ( GV @ ) , Sishencong ( EX-HN @ ) , etc. .


The ten treatments made one session .


After four sessions of treatment , FIQ value in Wechsler intelligence scale , CIH score in Conners children behavior questionnaire , the ratio of @ wave and p wave in EEG , FRCQ and FAQ in the integrated visual and auditory continuous performance test ( IVA-CPT ) and clinical comprehensive efficacy were observed before and after treatment in the two groups separately .


Three cases were dropped out in the observation group and @ cases were out in the control group .


In the two groups , FIQ , FRCQ and FAQ were all increased after treatment ( P < @ , P < @ ) ; the increases in the observation group were much more significant than those in the control group after treatment ( all P < @ ) .


In the two groups , CIH score and the ratio of @ wave and p wave were all reduced after treatment ( P < @ , P < @ ) ; the reduction in the observation group were much more apparent as compared with those in the control group ( both P < @ ) .


The total effective rate was @ % ( @/@ ) in the observation group and better than @ % ( @/@ , P < @ ) in the control group .


The combined therapy of scalp acupuncture and EEG biofeedback achieves the superior efficacy on children ADHD as compared with the simple biofeedback therapy .


This combined therapy rapidly relieves the essential symptoms of ADHD and improves EEG waveform in children patients .


Importantly , this therapy obtains and consolidates the significant efficacy .


Although p@ protein expression , a surrogate marker of oncogenic human papillomavirus ( HPV ) infection , is recognized as a prognostic marker in oropharyngeal squamous cell carcinoma ( OPSCC ) , its prevalence and significance have not been well established in cancer of the oral cavity , hypopharynx , or larynx , collectively referred as non-OPSCC , where HPV infection is less common than in the oropharynx .


p@ expression and high-risk HPV status in non-OPSCCs from RTOG @ , @ , and @ studies were determined by immunohistochemistry ( IHC ) and in situ hybridization ( ISH ) .


Hazard ratios from Cox models were expressed as positive or negative , stratified by trial , and adjusted for clinical characteristics .


p@ expression was positive in @ % ( @ of @ ) , @ % ( @ of @ ) , and @ % ( @ of @ ) and HPV ISH was positive in @ % ( six of @ ) , @ % ( @ of @ ) , and @ % ( seven of @ ) of non-OPSCCs from RTOG @ , @ , and @ studies , respectively .


Hazard ratios for p@ expression were @ ( @ % CI , @ to @ ; P = @ ) and @ ( @ % CI , @ to @ ; P = @ ) for progression-free ( PFS ) and overall survival ( OS ) , respectively .


Comparing OPSCC and non-OPSCC , patients with p@-positive OPSCC have better PFS and OS than patients with p@-positive non-OPSCC , but patients with p@-negative OPSCC and non-OPSCC have similar outcomes .


Similar to results in patients with OPSCC , patients with p@-negative non-OPSCC have worse outcomes than patients with p@-positive non-OPSCC , and HPV may also have a role in outcome in a subset of non-OPSCC .


However , further development of a p@ IHC scoring system in non-OPSCC and improvement of HPV detection methods are warranted before broad application in the clinical setting .


Fatigue and emotional reactivity are common among women suffering from breast cancer and might detrimentally affect these women 's quality of life .


This study evaluates if the stress management delivered either in a group or individual setting would improve fatigue and emotional reactivity among women with a newly diagnosed breast cancer .


Participants ( n = @ ) who reported elevated levels of distress at three-month post-inclusion were randomised between stress management in a group ( GSM ) ( n = @ ) or individual ( ISM ) ( n = @ ) setting .


Participation was declined by @ women .


Participants completed the Multidimensional Fatigue Inventory ( MFI-@ ) and the Everyday Life Stress Scale ( ELSS ) at the time of inclusion , @ - and @-month post-inclusion .


Analyses were made according to intention to treat and per-protocol principles .


Mann-Whitney tests were used to examine differences between the two intervention groups .


No significant differences were detected between the GSM and ISM groups on fatigue or emotional reactivity .


In addition , there were no changes over time for these outcomes .


There were no differences between the two intervention arms with reference to fatigue or emotional reactivity ; however , a clinically interesting finding was the low number of women who were interested in participating in a psychosocial intervention .


This finding may have clinical implications when psychosocial support is offered to women with a newly diagnosed breast cancer and also in the planning of future studies .


To improve the quality of chest compression ( CC ) , we developed the assistant-push method , whereby the second rescuer pushes the back of the chest compressor during CC .


We investigated the effectiveness and feasibility of assistant push in achieving and maintaining the CC quality .


This was a randomized crossover trial in which @ subjects randomly performed both of standard CC ( single-rescuer group ) and CC with instructor-driven assistant push ( assistant-push group ) in different order .


Each session of CC was performed for @ minutes using a manikin .


Subjects were also assigned to both roles of chest compressor and assistant and together performed CC with subject-driven assistant push .


Depth of CC , compression to recoil ratio , duty cycle , and rate of incomplete recoil were quantified .


The mean depth of CC ( @ -LSB- @-@ @ -RSB- vs @ -LSB- @-@ @ -RSB- , P < @ ) was significantly deeper , and the compression force ( @ -LSB- @-@ @ -RSB- vs @ -LSB- @-@ @ -RSB- , P < @ ) was stronger in the assistant-push group .


The ratio of compression to recoil , duty cycle , and rate of incomplete chest recoil were comparable between the @ groups .


The CC depth in the single-rescuer group decreased significantly every @ seconds , whereas in the assistant-push group , it was comparable at @ - and @-second time points ( P = @ ) .


The subject assistant-push group performed CCs at a depth comparable with that of the instructor assistant-push group .


The assistant-push method improved the depth of CC and attenuated its decline , eventually helping maintain adequate CC depth over time .


Subjects were able to feasibly learn assistant push and performed effectively .


Midodrine is an - agonist prodrug of desglymidodrine used for the management of hypotension .


Midodrine has demonstrated usefulness in hepatorenal syndrome .


The objective of the present work was to study the role of midodrine in patients with non-azotemic cirrhosis with tense ascites .


This prospective randomized double blind placebo-controlled study was conducted on @ non azotemic inpatients with liver cirrhosis and tense ascites ( @ men and @ women ; age range , @-@ ) .


One patient declined to participate in the study , @ patients were randomly assigned to take midodrine hydrochloride , and @ patients were randomly assigned to take placebo .


Out of @ enrolled patients , @ patients ( @ : in midodrine group ; @ : in placebo group ) completed the study and @ patients lost to follow up .


Patients were assessed for patients characteristics , history of tapping their ascetic fluid , laboratory values , and Doppler parameters before and after the study .


Average @-h urine volume was assessed before and after the start of the study .


significant reduction in body weight and abdominal girth was observed after @ weeks of midodrine therapy .


Midodrine appeared to be effective in lowering body weights and abdominal girths of non azotemic cirrhotic patients with tense ascites .


Antiarrhythmic drugs ( AADs ) and anticoagulation are mainstays of atrial fibrillation ( AF ) treatment .


To study the use and outcomes of AAD therapy in anticoagulated patients with AF .


Patients in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation trial ( N = @,@ ) were stratified by AAD use at baseline : amiodarone , other AAD , or no AAD .


Multivariable adjustment was performed to compare stroke , bleeding , and death across AAD groups as well as across treatment assignment ( rivaroxaban or warfarin ) .


Of @,@ patients randomized , @ ( @ % ) were treated with an AAD ( @ -LSB- @ % -RSB- with amiodarone and @ -LSB- @ % -RSB- with other AADs ) .


Amiodarone-treated patients were less often female ( @ % vs @ % ) , had more persistent AF ( @ % vs @ % ) , and more concomitant heart failure ( @ % vs @ % ) than were patients receiving other AADs .


Patients receiving no AAD more closely resembled amiodarone-treated patients .


Time in therapeutic range was significantly lower in warfarin-treated patients receiving amiodarone than in those receiving no AAD ( @ % vs @ % ; P < @ ) .


Compared with no AAD , neither amiodarone ( adjusted hazard ratio -LSB- HR -RSB- @ ; @ % confidence interval -LSB- CI -RSB- @-@ @ ; P = @ ) nor other AADs ( adjusted HR @ ; @ % CI @-@ @ ; P = @ ) were associated with increased mortality .


Similar results were observed for embolic and bleeding outcomes .


Treatment effects of rivaroxaban vs warfarin in patients receiving no AAD were consistent with results from the overall trial ( primary end point : adjusted HR @ ; @ % CI @-@ @ ; Pinteraction = @ ; safety end point : adjusted HR @ ; @ % CI @-@ @ ; Pinteraction = @ ) .


Treatment with AADs was not associated with increased morbidity or mortality in anticoagulated patients with AF .


The effect of amiodarone on outcomes in patients receiving rivaroxaban requires further investigation .


Mental stress-induced myocardial ischemia ( MSIMI ) is common in patients with ischemic heart disease ( IHD ) and associated with a poorer cardiovascular prognosis .


Platelet hyperactivity is an important factor in acute coronary syndrome .


This study examined associations between MSIMI and resting and mental stress-induced platelet activity .


Eligible patients with clinically stable IHD underwent a battery of @ mental stress tests during the recruitment phase of REMIT study .


MSIMI was assessed by echocardiography and electrocardiography .


Ex vivo platelet aggregation in response to ADP , epinephrine , collagen , serotonin , and combinations of serotonin plus ADP , epinephrine , and collagen were evaluated as was platelet serotonin transporter expression .


Of the @ participants who completed mental stress testing , and had both resting and post-stress platelet aggregation evaluation , @ % ( n = @ ) met criteria for MSIMI and @ % ( n = @ ) had normal left ventricular response to stress ( NLVR ) .


The MSIMI group , relative to the NLVR groups , demonstrated heightened mental stress-induced aggregation responses , as measured by area under the curve , to collagen @M ( @ -LSB- @ -RSB- vs. -@ -LSB- @ -RSB- .


; P = @ ) , epinephrine @M ( @ -LSB- @ -RSB- vs. -@ -LSB- @ -RSB- .


; P = @ ) and to serotonin @ M plus ADP @ M ( @ -LSB- @ -RSB- vs. -@ -LSB- @ -RSB- ; P < @ ) .


The resting platelet aggregation and serotonin transporter expression , however , were not different between the two groups .


These findings suggest that the dynamic change of platelet aggregation caused by mental stress may underlie MSIMI .


While the importance of these findings requires additional investigation , they raise concern given the recognized relationship between mental stress-induced platelet hyperactivity and cardiovascular events in patients with IHD .


Surgical and medical treatments for emphysema may affect both quality and quantity of life .


The purpose of this article is to report outcomes from the National Emphysema Treatment Trial ( NETT ) using an index that combines quality and quantity of life .


This was a prospective randomized clinical trial .


Following pulmonary rehabilitation , @,@ patients with severe emphysema were randomly assigned to maximal medical therapy or to lung volume reduction surgery ( LVRS ) .


A generic quality-of-life measure , known as the Quality of Well-being Scale ( QWB ) , was administered at baseline and again at @ , @ , @ , @ , @ , @ , and @ months following treatment assignment .


At baseline , QWB scores were comparable for the Medical and LVRS groups .


For both groups , scores significantly improved following the rehabilitation program .


The QWB scores before death for patients in the LVRS group improved up to the year @ visit , whereas scores for the Medical group dropped significantly following the baseline visit .


Imputing zeros ( @ ) for death , QWB scores decreased significantly for both groups .


With or without scoring death as @ , the LVRS group achieved better outcomes , and the significant differences were maintained until the sixth year .


Over @ years of follow-up , LVRS produced an average of @ quality-adjusted life years ( QALYs ) , or the equivalent of about @ months of well life .


Compared with maximal medical therapy alone , patients undergoing maximal medical therapy plus LVRS experienced improved health-related quality of life and gained more QALYs .


To observe the effect of combination of Immune @ and HAART on the CD@ + T cell count and its immune reconstitution rate .


Two hundred and twenty eight HIV/AIDS patients were randomly divided into treatment group and control group , patients from treatment group received Immune @ combined HAART therapy , patients from control group was given placebo combined HAART and evaluate the change of CD@ + T cell count and its immune reconstitution rate .


In patients with CD@ + T cells baseline level ( @-@ cell x microL ( -@ ) ) , Immune reconstitution rate of treatment group is significantly higher than the control group .


Immune @ combined HAART can effectively promote the immune reconstitution of patients with high CD@ + T cells baseline level ( @-@ cell x microL ( -@ ) ) and show little side effect and is safe to treat HIV/AIDS disease .


Concurrent treatment of HIV and tuberculosis is complicated by drug interactions .


We explored the safety and efficacy of raltegravir as an alternative to efavirenz for patients co-infected with HIV and tuberculosis .


We did a multicentre , phase @ , non-comparative , open-label , randomised trial at eight sites in Brazil and France .


Using a computer-generated randomisation sequence , we randomly allocated antiretroviral-naive adult patients with HIV-@ and tuberculosis ( aged @ years with a plasma HIV RNA concentration of > @ copies per mL ) to receive raltegravir @ mg twice a day , raltegravir @ mg twice daily , or efavirenz @ mg once daily plus tenofovir and lamivudine ( @:@:@ ; stratified by country ) .


Patients began study treatment after the start of tuberculosis treatment .


The primary endpoint was virological suppression at @ weeks ( HIV RNA < @ copies per mL ) in all patients who received at least one dose of study drug ( modified intention-to-treat analysis ) .


We recorded death , study drug discontinuation , and loss to follow-up as failures to achieve the primary endpoint .


We assessed safety in all patients who received study drugs .


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


Between July @ , @ , and June @ , @ , we enrolled and randomly assigned treatment to @ individuals ; @ ( @ in each group ) received at least one dose of the study drug and were included in the primary analysis .


@ patients ( @ % ) completed follow-up at week @ .


At week @ , virological suppression was achieved in @ patients ( @ % , @ % CI @-@ ) in the raltegravir @ mg group , @ patients ( @ % , @-@ ) in the raltegravir @ mg group , and @ patients ( @ % , @-@ ) in the efavirenz group .


The adverse-event profile was much the same across the three groups .


Three ( @ % ) patients allocated to efavirenz and three ( @ % ) patients allocated to raltegravir @ mg twice daily discontinued the study drugs due to adverse events .


Seven patients died during the study ( one in the raltegravir @ mg group , four in the raltegravir @ mg group , and two in the efavirenz group ) : none of the deaths was deemed related to study treatment .


Raltegravir @ mg twice daily might be an alternative to efavirenz for the treatment of patients co-infected with HIV and tuberculosis .


Panobinostat is a potent oral pan-deacetylase inhibitor that in preclinical studies has synergistic anti-myeloma activity when combined with bortezomib and dexamethasone .


We aimed to compare panobinostat , bortezomib , and dexamethasone with placebo , bortezomib , and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma .


PANORAMA@ is a multicentre , randomised , placebo-controlled , double-blind phase @ trial of patients with relapsed or relapsed and refractory multiple myeloma who have received between one and three previous treatment regimens .


Patients were randomly assigned ( @:@ ) via an interactive web-based and voice response system , stratified by number of previous treatment lines and by previous use of bortezomib , to receive @ day cycles of placebo or panobinostat ( @ mg ; on days @ , @ , @ , @ , @ , @ , orally ) , both in combination with bortezomib ( @ mg/m ( @ ) on days @ , @ , @ , @ , intravenously ) and dexamethasone ( @ mg on days @ , @ , @ , @ , @ , @ , @ , @ , orally ) .


Patients , physicians , and the investigators who did the data analysis were masked to treatment allocation ; crossover was not permitted .


The primary endpoint was progression-free survival ( in accordance with modified European Group for Blood and Marrow Transplantation criteria and based on investigators ' assessment ) and was analysed by intention to treat .


The study is ongoing , but no longer recruiting , and is registered at ClinicalTrials.gov , number NCT@ .


@ patients were enrolled between Jan @ , @ , and Feb @ , @ , with @ randomly assigned to panobinostat , bortezomib , and dexamethasone and @ to placebo , bortezomib , and dexamethasone .


Median follow-up was @ months ( IQR @-@ ) in the panobinostat group and @ months ( @-@ ) in the placebo group .


Median progression-free survival was significantly longer in the panobinostat group than in the placebo group ( @ months -LSB- @ % CI @-@ -RSB- vs @ months -LSB- @-@ -RSB- ; hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ ; p < @ ) .


Overall survival data are not yet mature , although at the time of this analysis , median overall survival was @ months ( @ % CI @-not estimable ) for the panobinostat group and @ months ( @-not estimable ) for the placebo group ( HR @ , @ % CI @-@ ; p = @ ) .


The proportion of patients achieving an overall response did not differ between treatment groups ( @ -LSB- @ % , @ % CI @-@ -RSB- for panobinostat vs @ -LSB- @ % , @-@ -RSB- for placebo ; p = @ ) ; however , the proportion of patients with a complete or near complete response was significantly higher in the panobinostat group than in the placebo group ( @ -LSB- @ % , @ % CI @-@ -RSB- vs @ -LSB- @ % , @-@ -RSB- ; p = @ ) .


Minimal responses were noted in @ ( @ % ) patients in the panobinostat group and in @ ( @ % ) in the placebo group .


Median duration of response ( partial response or better ) was @ months ( @ % CI @-@ ) in the panobinostat group and @ months ( @-@ ) in the placebo group , and median time to response ( partial response or better ) was @ months ( @-@ ) in the panobinostat group and @ months ( @-@ ) in the placebo group .


Serious adverse events were reported in @ ( @ % ) of @ patients in the panobinostat group and @ ( @ % ) of @ patients in the placebo group .


Common grade @-@ laboratory abnormalities and adverse events ( irrespective of association with study drug ) included thrombocytopenia ( @ -LSB- @ % -RSB- in the panobinostat group vs @ -LSB- @ % -RSB- in the placebo group ) , lymphopenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , diarrhoea ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , asthenia or fatigue ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and peripheral neuropathy ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Our results suggest that panobinostat could be a useful addition to the treatment armamentarium for patients with relapsed or relapsed and refractory multiple myeloma .


Longer follow up will be necessary to determine whether there is any effect on overall survival .


Corn peptides ( CPs ) are a novel food prepared from corn gluten meal , which is a main by-product of the corn starch industry .


Recently , significant beneficial effects of CPs on early alcoholic liver injury in rats and on acute alcoholic injury in mice were observed .


To our knowledge , the present study is the first report showing that CPs supplementation has beneficial effects on lipid profile , oxidative stress and alcoholic liver injury in men with chronic alcohol consumption .


A @-week , randomized , double-blind , placebo-controlled study was conducted between September @ and August @ to assess the hepatoprotective effect of CPs .


A total of @ men were randomized to receive CPs ( n = @ ) , whey protein ( n = @ ) , or corn starch placebo ( n = @ ) at the same dose of @ g twice daily .


@ participants completed the study .


Serum lipid profile , serum markers of liver injury , oxidative stress and inflammation , and fatty liver based on the results of abdominal ultrasonography were assessed at the beginning and end of the intervention .


CPs supplementation ( @ g/d ) for @ weeks significantly lowered serum levels or activities of total cholesterol , triglyceride , alanine aminotransferase , aspartate aminotransferase , malondialdehyde and tumor necrosis factor - , and significantly increased serum activities of superoxide dismutase and glutathione peroxidase , but the same dose of whey protein and corn starch ( placebo ) did not demonstrate these effects .


Our results indicate that CPs may have protective effects on alcohol-induced liver damage via modulation of lipid metabolism and oxidative stress .


CPs may potentially be used as a functional food for the management of alcoholic liver disease in subjects with chronic alcohol consumption .


The aim of this study was to investigate the effect of i.v. infusion of magnesium sulphate during spinal anesthesia on duration of spinal block and postoperative pain .


Forty ASA physical status I and status II , aged between @ and @ , female patients undergoing abdominal hysterectomy under spinal anesthesia were enrolled in this study .


Patients in the magnesium group ( Group M , n = @ ) received magnesium sulphate @ mg kg ( -@ ) infusion in @ mL @ % dextrose at @ mL/min rate , and control group ( Group C , n = @ ) received at the same volume of saline during operation in a double-blind randomized manner .


Duration of sensory and motor block , systolic , diastolic , and mean arterial blood pressures , heart rates , pain scores ( VAS values ) , and side effects were recorded for each patient .


Blood and CSF samples were taken for analysis of magnesium concentrations .


Regression of sensorial block was longer in Group M when compared with that in Group C ( @ @ versus @ @ min ) ( P < @ ) .


The VAS scores were lower in Group M than those in Group C at the @ time points postoperatively ( P < @ ) .


@ mg kg ( -@ ) of magnesium sulphate i.v. infusion under spinal anesthesia prolongs spinal sensorial block duration and decreases pain VAS scores without complication in patients undergoing abdominal hysterectomy .


To explore effects of a pre-screening life style survey on the subsequent attendance proportion in colorectal cancer screening .


Finnish colorectal cancer screening programme in @ .


Double randomized and controlled follow-up design .


The study population comprised of @,@ individuals born in @ .


In @ to a random sample of every sixth ( n = @,@ ) person we sent a @-paged life style questionnaire , and to another random sample of every sixth person ( n = @,@ ) a @-paged life style and quality of life questionnaire .


One year later , in @ , @,@ individuals of the original cohort were independently randomized ( @:@ ) for colorectal cancer screening ( n = @,@ ) or control group ( n = @,@ ) .


Of those who were invited for screening , @ had received a questionnaire during the previous year .


@ individuals ( @ % ) responded to the questionnaire in @ .


The overall attendance at screening in @ was @ % in those born in @ ( i.e. the @-year-olds ) .


In those who had been sent the survey the attendance in screening was @ % ( @ % for the short and @ % for the long questionnaire ) and in those who had not received the questionnaire it was @ % ( P < @ ) .


We believe that the observed reduction in attendance in those who had been sent a questionnaire earlier is generally true .


Thus , if any survey is enclosed in the screening invitation , this finding should be taken into account when planning the programme .


Any extra effort requested may reduce the attendance proportion for screening , reducing the population level impact of screening .


Under the directly observed treatment , short course ( DOTS ) program , antituberculosis ( anti-TB ) medications were possibly taken at random time , regardless of whether it was prior to or after meals .


This study was to evaluate the impact of food intake on pharmacokinetic profiles of first-line TB drugs in Taiwanese TB patients , as well as the relationship between drug levels and pharmacogenetics .


This open-label , randomized , cross-over study included newly diagnosed Taiwanese TB patients treated between January @ and February @ at Taipei Medical University-Wan Fang Hospital .


Rifater -LSB- a fixed-dose combination formulation of isoniazid ( INH ) , rifampicin ( RIF ) , and pyrazinamide ( PZA ) -RSB- and ethambutol ( EMB ) were given according to national TB guidelines .


Blood samples were collected prior to and @ hour , @ hours , @ hours , @ hours , and @ hours after dosing under fasting or postprandial conditions .


Pharmacokinetic parameters of the maximum serum concentration ( Cmax ) , time to Cmax , and area under the serum concentration-time curve from the beginning to the @ ( th ) hour ( AUC@-@ ) were calculated .


Sixteen TB patients were included and received anti-TB treatment under the DOTS program after discharge .


The overall effects showed that food intake reduced the mean Cmax ( INH : @ % , RIF : @ % , EMB @ % , PZA : @ % ) and AUC@-@ ( INH : @ % , RIF : @ % , EMB : @ % , PZA : @ % ) .


Meanwhile , food increased the time to Cmax ( INH : @ % , RIF : @ % , EMB : @ % , PZA : @ % ) .


Significantly lower serum drug concentrations were observed under postprandial conditions than fasting conditions for INH , RIF , and PZA .


The impact of taking random anti-TB drugs under the DOTS program instead of taking drugs regularly prior to meals requires further study .


Bevacizumab has broad anti-tumour activity , but substantial risk of hypertension .


No reliable markers are available for predicting bevacizumab-induced hypertension .


A genome-wide association study ( GWAS ) was performed in the phase III bevacizumab-based adjuvant breast cancer trial , ECOG-@ , to evaluate for an association between genotypes and hypertension .


GWAS was conducted in those who had experienced systolic blood pressure ( SBP ) > @mmHg during therapy using binary analysis and a cumulative dose model for the total exposure of bevacizumab .


Common toxicity criteria ( CTC ) grade @-@ hypertension was also assessed .


Candidate SNP validation was performed in the randomised phase III trial , ECOG-@ .


When using the phenotype of SBP > @mmHg , the most significant association in SV@C ( rs@ ) approached and met genome-wide significance in the binary model ( P = @ @ ( -@ ) ; OR = @ ) and in the cumulative dose model ( P = @ @ ( -@ ) ; HR = @ ) , respectively .


Similar associations with rs@ were seen for CTC grade @-@ hypertension but did not meet genome-wide significance .


Validation study from ECOG-@ demonstrated a statistically significant association between this SNP and grade @/@ hypertension using the binary model ( P-value = @ ; OR = @ ) .


A genetic variant in SV@C predicted clinically relevant bevacizumab-induced hypertension in two independent , randomised phase III trials .


This thorough QT/QTc ( TQT ) study assessed the effects of a supratherapeutic dose of pomaglumetad methionil , a potential treatment for schizophrenia , compared to placebo on the QT interval in subjects with schizophrenia .


This double-blind , @-period crossover study enrolled @ subjects aged @ - @ years , who met Diagnostic and Statistical Manual , Fourth Edition , Test Revision ( DSM-IV-TR ) criteria for schizophrenia ; @ subjects completed the study .


Subjects were randomly assigned to sequences of @ treatment periods of single oral doses of pomaglumetad methionil @ mg , moxifloxacin @ mg , and placebo .


Quadruplicate electrocardiograms ( ECGs ) were extracted from @ hours predose to @ hours postdose and were overread by a blinded central reader .


Time-matched pharmacokinetic ( PK ) parameters were assessed .


At all-time points , the upper bound of the @ % @-sided confidence interval ( CI ) for the least squares ( LS ) mean difference in changes from baseline in Fridericia 's corrected QT interval ( QTcF ) between pomaglumetad methionil and placebo was < @ milliseconds ( msec ) .


Sufficient assay sensitivity was not achieved , likely due to food effect ; although the maximum observed drug concentration ( Cmax ) with moxifloxacin ( @,@ ng/mL ) was lower than expected , the slope of the regression line of moxifloxacin plasma concentrations versus placebo-subtracted QTcF was similar to that reported in the literature .


A single supratherapeutic dose of @ mg pomaglumetad methionil did not prolong QTcF to a clinically significant degree and , importantly , did not result in any absolute QTcF > @ msec or increase in QTcF from predose > @ msec .


The purpose of this study was to evaluate the efficacy of once-daily guanfacine extended release ( GXR ) monotherapy administered either in the morning or evening , using a modified Conners ' Parent Rating Scale-Revised : Short Form ( CPRS-R : S ) assessed three times/day in children with attention-deficit/hyperactivity disorder ( ADHD ) .


This multicenter , double-blind , placebo-controlled study randomized children @-@ years of age with ADHD into three groups : GXR a.m. ( GXR in the morning and placebo in the evening ) , GXR p.m. ( placebo in the morning and GXR in the evening ) , or twice-daily placebo .


The CPRS-R : S , administered in the morning , afternoon , and evening prior to each study visit , was a secondary measure of efficacy .


A total of @ subjects were included in the analysis population ( GXR a.m. , n = @ ; GXR p.m. , n = @ ; placebo , n = @ ) .


At visit @ , last observation carried forward ( LOCF ) , subjects receiving GXR demonstrated significantly greater improvement from baseline in the daily mean CPRS-R : S total score , as well as in each of the morning , afternoon , and evening CPRS-R : S assessments , compared with placebo , regardless of the time of GXR administration ( p < @ vs. placebo for GXR a.m. and GXR p.m. ) .


In addition , subjects receiving GXR showed significantly greater improvements from baseline in each subscale score ( oppositional , cognitive problems/inattention , hyperactivity , and ADHD index ) compared with those receiving placebo , regardless of time of administration ( p < @ vs. placebo across all subscales for GXR a.m. and GXR p.m. ) .


These results provide further support for the demonstrated efficacy of once-daily GXR in reducing ADHD symptoms , and demonstrate that response is consistent throughout the day regardless of the time of administration , with improvement seen in ratings of oppositional as well as of ADHD symptoms .


Disease progression in patients with HER@-positive breast cancer receiving trastuzumab might be associated with activation of the PI@K/Akt/mTOR intracellular signalling pathway .


We aimed to assess whether the addition of the mTOR inhibitor everolimus to trastuzumab might restore sensitivity to trastuzumab .


In this randomised , double-blind , placebo-controlled , phase @ trial , we recruited women with HER@-positive , trastuzumab-resistant , advanced breast carcinoma who had previously received taxane therapy .


Eligible patients were randomly assigned ( @:@ ) using a central patient screening and randomisation system to daily everolimus ( @ mg/day ) plus weekly trastuzumab ( @ mg/kg ) and vinorelbine ( @ mg/m ( @ ) ) or to placebo plus trastuzumab plus vinorelbine , in @-week cycles , stratified by previous lapatinib use .


The primary endpoint was progression-free survival ( PFS ) by local assessment in the intention-to-treat population .


We report the final analysis for PFS ; overall survival follow-up is still in progress .


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


Between Oct @ , @ , and May @ , @ , @ patients were randomly assigned to everolimus ( n = @ ) or placebo ( n = @ ) .


Median follow-up at the time of analysis was @ months ( IQR @-@ @ ) .


Median PFS was @ months ( @ % CI @-@ @ ) with everolimus and @ months ( @-@ @ ) with placebo ( hazard ratio @ -LSB- @ % CI @-@ @ -RSB- ; p = @ ) .


The most common grade @-@ adverse events were neutropenia ( @ -LSB- @ % -RSB- of @ patients in the everolimus group vs @ -LSB- @ % -RSB- of @ patients in the placebo group ) , leucopenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , anaemia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , febrile neutropenia ( @ -LSB- @ % -RSB- vs ten -LSB- @ % -RSB- ) , stomatitis ( @ -LSB- @ % -RSB- vs four -LSB- @ % -RSB- ) , and fatigue ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Serious adverse events were reported in @ ( @ % ) patients in the everolimus group and @ ( @ % ) in the placebo group ; two on-treatment deaths due to adverse events occurred in each group .


The addition of everolimus to trastuzumab plus vinorelbine significantly prolongs PFS in patients with trastuzumab-resistant and taxane-pretreated , HER@-positive , advanced breast cancer .


The clinical benefit should be considered in the context of the adverse event profile in this population .


Opioid consumption after posterior spinal fusion is known to be high and often exceeds those reported in other major surgical procedures .


A number of clinical trials provide evidence that the perioperative use of subanesthetic doses of ketamine reduces pain and opioid requirements in some surgical procedures , but the effect of prolonged perioperative low-dose ketamine infusion in patients undergoing posterior spinal fusion for pediatric scoliosis surgery is unknown .


To test the hypothesis that a @-h perioperative low-dose ketamine infusion would decrease opioid use in pediatric patients undergoing posterior spinal fusion .


In a double-blind prospective controlled trial , patients undergoing posterior spinal fusion for scoliosis were randomized to receive perioperative low-dose ketamine or placebo control .


Patients received general anesthesia , intraoperative remifentanil , and morphine patient-controlled analgesia postoperatively .


Daily opioid consumption , self-reported pain scores , and sedation scores were measured .


Fifty-four patients were enrolled and @ completed the study .


Contrary to our hypothesis , ketamine - and control-treated patients had similar postoperative opioid use , pain scores , and sedation scores measurements .


In contrast , ketamine-treated patients required less intraoperative remifentanil compared with control ( mean @ mg vs. @mg , P = @ ) .


Number of vertebrae instrumented , time between end-of-surgery and @h assessment , or remifentanil doses did not impact on postoperative opioid use .


Over @-h postoperatively , morphine-equivalent consumption was lower ( -@ , P = @ ) and sedation score was higher ( @ , P = @ ) in male patients , compared with female patients .


These findings do not support the use of perioperative low-dose ketamine to decrease opioid use in children with scoliosis undergoing posterior spinal fusion .


Emollient therapy is used frequently to prevent nosocomial infection in the management of preterm infants , despite a lack of adequate evidence of its efficacy .


To assess the efficacy of prophylactic whole-body application of pure preservative-free topical petroleum jelly on the incidence of nosocomial sepsis in very low-birthweight ( VLBW ) infants .


A prospective , randomised controlled trial of the application of topical petroleum jelly was conducted .


Infants weighing < @ g at birth and with a gestational age of @ weeks were included .


The intervention group received twice-daily topical therapy of @ g/kg pure , preservative-free topical petroleum jelly until the completion of @ weeks of gestation .


The control group received no topical petroleum jelly treatment .


The primary outcome was the incidence of late-onset sepsis during hospitalisation .


Other data collected included the pattern of temperature control , weight changes , fluid requirements , serum bilirubin level , electrolyte imbalance and skin condition .


Thirty-five infants in the intervention group and @ in the control group were recruited .


Birthweight , gestational age , gender and perinatal variables were comparable in the two groups .


There was a trend towards an increased incidence of culture-proven nosocomial sepsis in the intervention group - @ episodes ( @ % ) in the intervention group vs @ ( @ % ) in the control group , and an increased rate of NEC - @ % in the intervention group vs @ % in the control group .


The intervention group had better skin condition throughout their stay and the incubator ambient temperature was lower in the intervention group in the @st week of life .


The fluid balance of the infants in the intervention group was better , as reflected by their mean ( SD ) shorter time to regain birthweight -LSB- @ ( @ ) vs @ ( @ ) days -RSB- , and there were fewer episodes of hypernatraemia in the @st week of life , although none of these reached statistical significance .


However , there was a significantly lower mean ( SD ) level of maximum hyperbilirubinaemia -LSB- @ ( @ ) vs @ ( @ ) mmol/L , P = @ ) in the intervention group .


Although prophylactic topical application of pure , preservative-free petroleum jelly brought substantial improvement of skin condition and temperature control , it was associated with a trend towards an increased rate of nosocomial sepsis .


To study the efficacy and safety of drotaverine hydrochloride ( HCl ) @ mg tablet given thrice a day in the symptomatic relief of patients with irritable bowel syndrome ( IBS ) .


The study was a multicentric , randomized , double-blind , placebo-controlled parallel group study performed at three centers .


The patients who fulfilled Rome II Criteria of IBS were included in the study .


A total of @ patients with IBS were randomized to drotaverine and placebo treatment groups .


Abdominal pain and stool frequency were measured every week in both the groups for all the @ weeks of treatment duration .


Subject Global Assessment of Relief ( SGA ) of IBS symptoms was assessed at the end of the study .


Appropriate statistical analysis was done using SPSS software .


Mann-Whitney U-test ( two-tailed ) , Wilcoxon signed ranks test , and McNemar tests .


Pain frequency decreased significantly ( P < @ ) in @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) patients in the drotaverine group , at the end of @nd , @rd , and @th weeks , respectively , as compared with @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) in the placebo group .


Pain severity scores also decreased significantly in the drotaverine group @ ( @ % ) as compared with placebo @ ( @ % ) after @ weeks .


Drotaverine HCl was shown to provide significant improvement ( P < @ ) in global relief in abdominal pain as perceived by the patient ( @ % vs @ % ) and the clinician ( @ % vs @ % ) in the drotaverine group as compared with placebo .


There is significant ( P < @ ) improvement in stool frequency in drotaverine HCl treatment group as compared with placebo .


The drug is well tolerated without any major side effects .


A @-week treatment with drotaverine significantly improves abdominal symptoms in patients with IBS .