Sinemet CR in Parkinson 's disease . Sinemet CR , a controlled release carbidopa/levodopa preparation , was compared to conventional carbidopa/levodopa in a double blind , placebo-controlled trial . Comparable clinical benefits and adverse effects were noted with the two medications . However significantly less frequent dosing was necessary with Sinemet CR .

Sinemet CR

Sinemet CR

carbidopa/levodopa preparation

carbidopa/levodopa

placebo-controlled

clinical benefits

adverse effects

Sinemet CR in Parkinson 's disease .


Ten-year incidence of myocardial infarction and prognosis after infarction . Department of Veterans Affairs Cooperative Study of Coronary Artery Bypass Surgery . BACKGROUND The 10-year incidence of myocardial infarction ( fatal and nonfatal ) and the prognosis after infarction were evaluated in 686 patients with stable angina who were randomly assigned to medical or surgical treatment in the Veterans Administration Cooperative Study of Coronary Artery Bypass Surgery . METHODS AND RESULTS Myocardial infarction was defined by either new Q wave findings or clinical symptoms compatible with myocardial infarction accompanied by serum enzyme elevations with or without electrocardiographic findings . Treatment comparisons were made according to original treatment assignment ; 35 % of the medical cohort had bypass surgery during the 10-year follow-up period . The overall cumulative infarction rate was somewhat higher in patients assigned to surgery ( 36 % ) than in medical patients ( 31 % ) ( p = 0.13 ) due to perioperative infarctions ( 13 % ) and an accelerated infarction rate after the fifth year of follow-up ( average , 2.4 % /yr in the surgical group versus 1.4 % /yr in the medical group ) . The 10-year cumulative incidence of death or myocardial infarction was also higher in surgical ( 54 % ) than in medical ( 49 % ) patients ( p = 0.20 ) . According to the Cox model , the estimated risk of death after infarction was 59 % lower in surgical than in medical patients ( p less than 0.0001 ) . The reduction in postinfarction mortality with surgery was most striking in the first month after the event : 99 % in the first month ( p less than 0.0001 ) and 49 % subsequently ( p less than 0.0001 ) . The estimated risk of death in the absence of infarction was nearly identical regardless of treatment ( p = 0.75 ) . Exclusion of perioperative infarctions did not alter the findings . CONCLUSIONS Although surgery does not reduce the incidence of myocardial infarction overall , it does reduce the risk of mortality after infarction , particularly in the first 30 days after the event ( fatal infarctions ) .

medical

surgical treatment

bypass surgery

surgery

overall cumulative infarction rate

accelerated infarction rate

10-year cumulative incidence of death

myocardial infarction

reduction

postinfarction mortality

myocardial infarction

mortality

stable angina

myocardial infarction


Breast reduction alleviates depression and anxiety and restores self-esteem : a prospective randomised clinical trial . Of women who seek reduction mammaplasty , up to a third have pathological degrees of anxiety or depression , or both . The psychological aspect of reduction mammaplasty is therefore an important consideration . We did a prospective randomised clinical trial to see how reduction mammaplasty affected macromastia patients ' depression , anxiety , and self-esteem . Eighty-two patients were randomised , 40 to have the operation , and 42 patients to conservative treatment . Both groups were followed for six months . The patients completed the RBDI questionnaire ( Raitasalo 's modification of the short form of the Beck Depression Inventory ) . Twenty-nine patients in the operated group and 35 patients in the conservative group completed the study . At the second examination , the patients who had been operated on , had significantly less depression ( p < 0.01 ) and better self-esteem ( p=0.03 ) than the conservative group . The proportions of depressed ( p < 0.01 ) and anxious ( p=0.04 ) patients were also smaller in the group who were operated on . There is significantly less depression and anxiety after reduction mammaplasty , and patients ' self-esteem is restored .

Breast reduction

reduction mammaplasty

reduction mammaplasty

mammaplasty

depression and anxiety

self-esteem

anxiety or depression

psychological aspect

depression , anxiety

self-esteem

better self-esteem

depressed

anxious

depression

anxiety

self-esteem

women

reduction mammaplasty

anxiety

depression

Eighty-two


The 6 minute walk in idiopathic pulmonary fibrosis : longitudinal changes and minimum important difference . RATIONALE The response characteristics of the 6 minute walk test ( 6MWT ) in studies of idiopathic pulmonary fibrosis ( IPF ) are only poorly understood , and the change in walk distance that constitutes the minimum important difference ( MID ) over time is unknown . OBJECTIVES To examine changes over time in distance walked ( ie , 6MWD ) during the 6MWT and to estimate the change in distance that constitutes the MID in patients with IPF . METHODS Data from a recently completed trial that included subjects with IPF who completed the 6MWT , Saint George 's Respiratory Questionnaire ( SGRQ ) and forced vital capacity ( FVC ) at 6 and 12 months were used to examine longitudinal changes in 6MWD . Both anchor- and distribution-based approaches as well as linear regression analyses were used to determine the MID for 6MWD . The SGRQ Total score and FVC were used as clinical anchors . MAIN RESULTS Among 123 subjects alive and able to complete the 6MWT at both follow-up time points , 6MWD did not change significantly over time ( 378.1 m at baseline vs 376.8 m at 6 months vs 361.3 m at 12 months , p=0.5 ) . The point estimate for the 6MWD MID was 28 m with a range of 10.8-58.5 m. CONCLUSION In a group of patients with IPF with moderate physiological impairment , for those alive and able to complete a 6MWT , 6MWD does not change over 12 months . At the population level , the MID for 6MWD appears to be approximately 28 m. Further investigation using other anchors and derivation methods is required to refine estimates of the MID for 6MWD in this patient population .

6 minute walk test ( 6MWT )

time in distance walked

SGRQ Total score and FVC


Bioequivalence evaluation of a fixed dose combination lamivudine + stavudine tablet with concurrent administration of lamivudine tablet and stavudine capsule in healthy volunteers . The study was designed to compare the rate and extent of absorption of a fixed dose combination tablet of lamivudine ( CAS 134678-17-4 ) and stavudine ( CAS 3056-17-5 ) with the concurrent administration of lamivudine tablet and stavudine capsule in 24 healthy volunteers under fasting conditions . The volunteers were randomly assigned to the test or reference treatment , with the two treatment periods separated by a washout period of at least 7 days . Plasma samples were analyzed for both analytes lamivudine and stavudine by a validated analytical method . Since the 90 % confidence intervals for the " test/reference " mean ratio of the In-transformed pharmacokinetic variables C ( max ) AUC ( 0-t ) and AUC ( 0-infinity ) were clearly within the conventional bioequivalence range of 80 % to 125 % , the two treatments were considered bioequivalent . The safety profiles of both the test and reference formulations were comparable .

lamivudine + stavudine

lamivudine

stavudine

lamivudine ( CAS 134678-17-4 )

stavudine ( CAS 3056-17-5 )

lamivudine tablet

stavudine capsule

lamivudine

stavudine

rate and extent of absorption

Plasma samples

test/reference

safety profiles

under fasting


Effects of Thai traditional massage on autistic children 's behavior . OBJECTIVES The objective of this study was to access whether there were any therapeutic effects of Thai Traditional Massage ( TTM ) on major behavioral and emotional disturbances in Thai autistic children . DESIGN This was a randomized controlled trial study . SETTINGS/LOCATION The study was conducted at the Rehabilitation Centre of the Thai Red Cross Society . SUBJECTS A total of 60 autistic children between the ages of 3 and 10 completed this study . INTERVENTIONS Standard sensory integration therapy ( SI ) was compared to the SI with TTM treatments . OUTCOME MEASURES Parents and teachers assessed major behavior disturbances using the Conners ' Rating Scales at 0 and 8 weeks . Sleep Diary ( SD ) , recorded by the parents , assessed the patient 's sleeping patterns every week . RESULTS Sixty ( 60 ) autistic children , mean age 4.67 +/- 1.82 , were recruited . No statistical differences were seen in the demographic and baseline data among both groups . From both the Conners ' Teacher Questionnaire and SD , statistical improvement was detected for conduct problem , hyperactivity , inattention-passivity , hyperactivity index , and sleeping behavior . However , results from the Conners ' Parent Questionnaire revealed an improvement only for anxiety ( p = 0.04 ) in the massage group , whereas when both groups were compared , a significant improvement in conduct problem ( p = 0.03 ) and anxiety ( p = 0.01 ) was found . Results indicated that TTM may have a positive effect in improving stereotypical behaviors in autistic children . CONCLUSIONS Over a period of 8 weeks , our findings suggested that TTM could be used as a complementary therapy for autistic children in Thailand .

Thai Traditional Massage ( TTM )

TTM

major behavior disturbances

Conners ' Rating Scales

Sleep Diary ( SD )

Conners ' Teacher Questionnaire

SD

Conners ' Parent Questionnaire

anxiety

conduct problem

anxiety

stereotypical behaviors

autistic

children 's

autistic

3 and 10

Sixty ( 60 )

autistic

4.67 +/- 1.82


A multi-center , randomized , controlled trial of parenteral nutrition titrated to resting energy expenditure in children undergoing hematopoietic stem cell transplantation ( " PNTREE " ) : rationale and design . BACKGROUND Children undergoing hematopoietic stem cell transplantation ( HSCT ) frequently require prolonged courses of parenteral nutrition ( PN ) as a consequence of gastrointestinal dysfunction related to preparative chemotherapy and radiation . PN has been associated with shorter engraftment time and decreased mortality during HSCT , however , it is also linked with complications , including infections , liver disease , and metabolic disturbances . Some of these complications may be a result of providing PN in excess of nutrient requirements . We previously described significant reductions in resting energy expenditure ( REE ) , as measured by indirect calorimetry , over the course of HSCT . We also documented a decline in mid-arm muscle area , suggesting depletion of muscle mass , while triceps skinfold , a marker of fat stores , was unchanged . These results suggested the need for further study of energy expenditure , body composition and nutritional intake in this group of high risk patients . DESIGN AND HYPOTHESIS We hypothesize that changes in body composition affect REE during HSCT , and that standard nutritional support may lead to overfeeding . We are performing a randomized controlled trial of parenteral nutrition among children undergoing allogeneic HSCT . Subjects are randomized to receive PN designed to provide 100 % of measured REE , or standard PN , i.e. , 140 % of estimated energy expenditure . The primary outcome variable is change in percent body fat . Secondary outcomes include glycemic control and frequency of infections , changes in REE and body composition . CONCLUSION This study will provide unique and comprehensive nutritional data and its results will guide nutritional therapy for children undergoing HSCT and possibly other catabolic patients .

parenteral nutrition

parenteral nutrition ( PN )

parenteral nutrition

, or standard PN , i.e.

140 % of estimated energy expenditure

infections

liver disease

, and

metabolic disturbances

change in percent body fat .

children

Children

children

allogeneic HSCT

children

HSCT


Optimum frequency of exercise for bone health : randomised controlled trial of a high-impact unilateral intervention . INTRODUCTION Exercise can increase bone strength , but to be effective in reducing fracture risk , exercise must be feasible enough to be adopted into daily life and influence potentially vulnerable skeletal sites such as the superolateral cortex of the femoral neck , where thinning is associated with increased fracture risk . Brief , high-impact exercise increases femoral neck bone density but the optimal frequency of such exercise and the location of bone accrual is unknown . This study thus examined ( 1 ) the effectiveness of different weekly frequencies of exercise on femoral neck BMD and ( 2 ) whether BMD change differed between hip sites using a high-impact , unilateral intervention . METHODS Healthy premenopausal women were randomly assigned to exercise 0 , 2 , 4 , or 7 days/week for 6 months . The exercise intervention incorporated 50 multidirectional hops on one randomly selected leg . BMD was measured by DXA at baseline and after 6 months of exercise . Changes in the exercise leg were compared between groups using ANCOVA , with change in the control leg and baseline BMD as covariates . RM-MANOVA was conducted to determine whether bone changes from exercise differed between hip sites . RESULTS 61 women ( age 33.6+/-11.1 years ) completed the intervention . Compliance amongst exercisers was 86.7+/-10.6 % . Peak ground reaction forces during exercise increased from 2.5 to 2.8 times body weight . The change in femoral neck BMD in the exercise limb ( adjusted for change in the control limb and baseline BMD ) differed between groups ( p=0.015 ) , being -0.3 % ( -1.2 to 0.6 ) , 0.0 % ( -1.0 to 1.0 ) , 0.9 % ( -0.1 to 2.0 ) and 1.8 % ( 0.8 to 2.8 ) in those exercising 0 , 2 , 4 and 7 days per week , respectively . When BMD changes at upper neck , lower neck and trochanter were compared using RM-MANOVA , a significant exercise effect was observed ( p=0.048 ) , but this did not differ significantly between sites ( p=0.439 ) despite greatest mean increases at the upper femoral neck . CONCLUSIONS Brief , daily hopping exercises increased femoral neck BMD in premenopausal women but less frequent exercise was not effective . Brief high-impact exercise may have a role in reducing hip fragility , but may need to be performed frequently for optimal response .

exercise

Exercise

exercise

Brief , high-impact exercise

exercise

exercise intervention

exercise

exercise

exercises

Brief high-impact exercise

bone health

bone strength

femoral neck bone density

femoral neck BMD

BMD

bone changes

Peak ground reaction forces

change in femoral neck BMD

femoral neck BMD

hip fragility

premenopausal women


Phase III , randomized , open-label study of daily imatinib mesylate 400 mg versus 800 mg in patients with newly diagnosed , previously untreated chronic myeloid leukemia in chronic phase using molecular end points : tyrosine kinase inhibitor optimization and selectivity study . PURPOSE To evaluate the safety and efficacy of initial treatment with imatinib mesylate 800 mg/d ( 400 mg twice daily ) versus 400 mg/d in patients with newly diagnosed chronic myeloid leukemia in chronic phase . PATIENTS AND METHODS A total of 476 patients were randomly assigned 2:1 to imatinib 800 mg ( n = 319 ) or 400 mg ( n = 157 ) daily . The primary end point was the major molecular response ( MMR ) rate at 12 months . RESULTS At 12 months , differences in MMR and complete cytogenetic response ( CCyR ) rates were not statistically significant ( MMR , 46 % v 40 % ; P = .2035 ; CCyR , 70 % v 66 % ; P = .3470 ) . However , MMR occurred faster among patients randomly assigned to imatinib 800 mg/d , who had higher rates of MMR at 3 and 6 months compared with those in the imatinib 400-mg/d arm ( P = .0035 by log-rank test ) . CCyR also occurred faster in the 800-mg/d arm ( CCyR at 6 months , 57 % v 45 % ; P = .0146 ) . The most common adverse events were edema , gastrointestinal problems , and rash , and all were more common in patients in the 800-mg/d arm . Grades 3 to 4 hematologic toxicity also occurred more frequently in patients receiving imatinib 800 mg/d . CONCLUSION MMR rates at 1 year were similar with imatinib 800 mg/d and 400 mg/d , but MMR and CCyR occurred earlier in patients treated with 800 mg/d . Continued follow-up is needed to determine the clinical significance of earlier responses on high-dose imatinib .

imatinib mesylate

imatinib mesylate

imatinib 800 mg

or 400 mg

imatinib

imatinib .

major molecular response ( MMR ) rate

MMR

MMR

CCyR

Grades 3 to 4 hematologic toxicity

MMR and CCyR


Divalproex sodium vs placebo for the treatment of irritability in children and adolescents with autism spectrum disorders . Autism spectrum disorders ( ASDs ) are neurodevelopmental disorders characterized by social and language deficits and by repetitive behaviors and interests . Irritability/aggression is a significant comorbid symptom in this population , which greatly impacts burden of care . This study examined the effect of divalproex sodium for irritability/aggression in children and adolescents with ASD . This was a 12-week randomized , double-blind , placebo-controlled trial . All efficacy measures were obtained by an independent evaluator blinded to randomization condition and side effects . A total of 55 subjects gavetheir consent and 27 were randomized in a 1 : 1 manner ( mean age 9.46+/-2.46 , mean nonverbal IQ 63.3+/-23.9 ) . Two subjects from the active group and one subject from the placebo group discontinued the study because of either a lack of efficacy or side effects ( increased irritability ) . Primary outcome measures were Aberrant Behavior Checklist-Irritability subscale and Clinical Global Impression-Improvement , which focused on irritability . Overall , 62.5 % of divalproex subjects vs 9 % of placebo subjects were responders ( CGI-irritability OR : 16.7 , Fisher 's exact p=0.008 ) . A statistically significant improvement was also noted on the ABC-Irritability subscale ( p=0.048 ) . There was a trend for responders to have higher valproate blood levels compared with nonresponders . This study suggests the efficacy of divalproex for the treatment of irritability in children and adolescents with ASD . Larger sample follow-up studies are warranted .

Divalproex sodium

placebo

divalproex sodium

placebo-controlled

placebo

divalproex

placebo

divalproex

irritability

efficacy

side effects

responders

ABC-Irritability subscale

valproate blood levels

efficacy

irritability

children

adolescents

autism spectrum disorders

children

adolescents

ASD


Effectiveness of initiating treatment with valsartan/hydrochlorothiazide in patients with stage-1 or stage-2 hypertension . This prospective , 6-week , multicenter , double-blind study examined the benefits of initiating treatment with combination valsartan/hydrochlorothiazide ( HCTZ ) compared with initial valsartan monotherapy for 648 patients with stage-1 or stage-2 hypertension ( age=52.6+/-10 years ; 54 % male ; baseline blood pressure ( BP ) =161/98 mm Hg , 32 % stage 1 ) . Patients were randomized to valsartan 80 mg ( V-low ) , valsartan 160 mg ( V-high ) or valsartan/HCTZ 160/12.5 mg ( V/HCTZ ) , and electively titrated after weeks 2 and 4 to the next dosage level ( maximum dose valsartan/HCTZ 160/25 mg ) if BP remained > 140/90 mm Hg . At end of the study , patients initiated with V/HCTZ required less titration steps compared with the initial valsartan monotherapy groups ( 63 vs 86 % required titration by study end , respectively ) and reached the target BP goal of < 140/90 mm Hg in a shorter period of time ( 2.8 weeks ) ( P < 0.0001 ) vs V-low ( 4.3 weeks ) and V-high ( 3.9 weeks ) . Initial combination therapy was also associated with higher BP control rates and greater reductions in both systolic and diastolic BP from baseline ( 63 % , -27.7+/-13/-15.1+/-8 mm Hg ) compared with V-low ( 46 % , -21.2+/-13/-11.4+/-8 mm Hg , P < 0.0001 ) or V-high ( 51 % , -24.0+/-13/-12.0+/-10 mm Hg , P < 0.01 ) . Overall and drug-related AEs were mild to moderate and were similar between V/HCTZ ( 53.1 and 14.1 % , respectively ) and the two monotherapy groups , V-low ( 50.5 and 13.8 % ) and V-high ( 50.7 and 11.8 % ) . In conclusion , initiating therapy with a combination of valsartan and low-dose HCTZ results in early , improved BP efficacy with similar tolerability as compared with starting treatment with a low or higher dose of valsartan for patients with stage-1 and stage-2 hypertension .

valsartan/hydrochlorothiazide

valsartan/hydrochlorothiazide ( HCTZ )

valsartan 80 mg ( V-low )

valsartan 160 mg ( V-high )

valsartan/HCTZ 160/12.5 mg ( V/HCTZ )

maximum dose valsartan/HCTZ 160/25 mg

BP remained > 140/90 mm Hg

V/HCTZ

V/HCTZ

valsartan

HCTZ

valsartan

less titration steps

BP goal

BP control rates

drug-related AEs

early , improved

BP efficacy

tolerability

age=52.6+/-10 years

male


Clinical pharmacology of methadone in dogs . OBJECTIVE To investigate the pharmacokinetics and effects of methadone on behaviour and plasma concentrations of cortisol and vasopressin in healthy dogs . STUDY DESIGN Randomized , cross-over , experimental trial . ANIMALS Nine adult dogs ( beagle and beagle cross breeds ) , four males and five females . METHODS Methadone hydrochloride , 0.4 mg kg ( -1 ) , was administered intravenously ( IV ) and subcutaneously ( SC ) with a crossover design . Drug and hormone analyses in plasma were performed using Liquid Chromatography-Electrospray Ionization-Tandem Mass Spectrometry and radioimmunoassay respectively . Behavioural data were collected using a standardized protocol . RESULTS After IV administration , the plasma concentration of methadone at 10 minutes was 82.1 +/- 9.2 ng mL ( -1 ) ( mean +/- SD ) , the terminal half-life was 3.9 +/- 1.0 hours , the volume of distribution 9.2 +/- 3.3 L kg ( -1 ) and plasma clearance 27.9 +/- 7.6 mL minute ( -1 ) kg ( -1 ) . After SC administration , time to maximal plasma concentration was 1.26 +/- 1.04 hours and maximal plasma concentration of methadone was 23.9 +/- 14.4 ng mL ( -1 ) , the terminal half-life was 10.7 +/- 4.3 hours and bioavailability was 79 +/- 22 % . Concentrations of both cortisol and vasopressin were increased for an hour following IV methadone . The observed behavioural effects of methadone were decreased licking and swallowing and an increase in whining after SC administration . The latter finding is notable as it can be misinterpreted as pain when methadone is used as an analgesic . CONCLUSION AND CLINICAL RELEVANCE When methadone was administered by the SC route , the half-life was longer , but the individual variation in plasma concentrations was greater compared with IV administration . Increased frequency of whining occurred after administration of methadone and may be a drug effect and not a sign of pain . Cortisol and vasopressin concentrations in plasma may not be suitable for evaluating analgesia after methadone treatment .

methadone

methadone

Methadone hydrochloride

radioimmunoassay

methadone

methadone

methadone

methadone

methadone

methadone

methadone

pharmacokinetics

behaviour

Behavioural data

plasma concentration of methadone

licking and swallowing

whining

pain

variation in plasma concentrations

frequency of whining

analgesia

dogs .

healthy dogs .


Body size indexes for optimizing iodine dose for aortic and hepatic enhancement at multidetector CT : comparison of total body weight , lean body weight , and blood volume . PURPOSE To evaluate and compare total body weight ( TBW ) , lean body weight ( LBW ) , and estimated blood volume ( BV ) for the adjustment of the iodine dose required for contrast material-enhanced multidetector computed tomography ( CT ) of the aorta and liver . MATERIALS AND METHODS Institutional review committee approval and written informed consent were obtained . One hundred twenty patients ( 54 men , 66 women ; mean age , 64.1 years ; range , 19-88 years ) who underwent multidetector CT of the upper abdomen were randomized into three groups of 40 patients each : ( a ) TBW group ( 0.6 g of iodine per kilogram of TBW ) , ( b ) LBW group ( 0.821 g of iodine per kilogram of LBW ) , and ( c ) BV group ( men , 8.6 g of iodine per liter of BV ; women , 9.9 g of iodine per liter of BV ) . Change in CT number between unenhanced and contrast-enhanced images per gram of iodine and maximum hepatic enhancement ( MHE ) adjusted for iodine dose were examined for correlation with TBW , LBW , and BV by using linear regression analysis . RESULTS In the portal venous phase , correlation coefficients for the correlation of change in CT number per gram of iodine with TBW for the aorta and liver were -0.71 and -0.79 , respectively , in the TBW group ; -0.80 and -0.86 , respectively , in the LBW group ; and -0.68 and -0.66 , respectively , in the BV group . In the liver , they were marginally higher in the LBW group than in the BV group ( P = .03 ) . Adjusted MHE remained constant at 77.9 HU +/- 10.2 ( standard deviation ) in the LBW group with respect to TBW , but it increased in the TBW ( r = 0.80 , P < .001 ) and BV ( r = 0.70 , P < .001 ) groups as TBW increased . CONCLUSION When LBW , rather than TBW or BV , is used , the iodine dose required to achieve consistent hepatic enhancement may be estimated more precisely and with reduced patient-to-patient variability .

iodine

iodine dose

multidetector CT

iodine

iodine

iodine

iodine

iodine

iodine

total body weight ( TBW )

lean body weight ( LBW )

estimated blood volume ( BV )

correlation coefficients

TBW

Adjusted MHE

LBW

TBW

TBW

BV

TBW

LBW

TBW

BV


Randomized controlled trial for early intervention for autism : a pilot study of the Autism 1-2-3 Project . We piloted a 2-week " Autism-1-2-3 " early intervention for children with autism and their parents immediately after diagnosis that targeted at ( 1 ) eye contact , ( 2 ) gesture and ( 3 ) vocalization/words . Seventeen children were randomized into the Intervention ( n = 9 ) and Control ( n = 8 ) groups . Outcome measures included the Autism Diagnostic Observation Schedule , Ritvo-Freeman Real Life Rating Scale , Symbolic Play Test , and Parenting Stress Index . Children with autism improved in language/communication , reciprocal social interaction , and symbolic play . Parents perceived significant improvement in their children 's language , social interaction , and their own stress level . This intervention can serve as short-term training on communication and social interaction for children with autism , and reduce the stress of their parents during the long waiting time for public health services .

early intervention

Autism 1-2-3 Project

" Autism-1-2-3 " early intervention

Intervention

Control

Autism Diagnostic Observation Schedule

Ritvo-Freeman Real Life Rating Scale

Symbolic Play Test

Parenting Stress Index

language/communication

reciprocal social interaction

symbolic play

children 's language

social interaction

their own stress level

children

autism

Seventeen


Rituximab plus concurrent infusional EPOCH chemotherapy is highly effective in HIV-associated B-cell non-Hodgkin lymphoma . Rituximab plus intravenous bolus chemotherapy is a standard treatment for immunocompetent patients with B-cell non-Hodgkin lymphoma ( NHL ) . Some studies have suggested that rituximab is associated with excessive toxicity in HIV-associated NHL , and that infusional chemotherapy may be more effective . We performed a randomized phase 2 trial of rituximab ( 375 mg/m ( 2 ) ) given either concurrently before each infusional etoposide , vincristine , doxorubicin , cyclophosphamide , and prednisone ( EPOCH ) chemotherapy cycle or sequentially ( weekly for 6 weeks ) after completion of all chemotherapy in HIV-associated NHL . EPOCH consisted of a 96-hour intravenous infusion of etoposide , doxorubicin , and vincristine plus oral prednisone followed by intravenous bolus cyclophosphamide given every 21 days for 4 to 6 cycles . In the concurrent arm , 35 of 48 evaluable patients ( 73 % ; 95 % confidence interval , 58 % -85 % ) had a complete response . In the sequential arm , 29 of 53 evaluable patients ( 55 % ; 95 % confidence interval , 41 % -68 % ) had a complete response . The primary efficacy endpoint was met for the concurrent arm only . Toxicity was comparable in the 2 arms , although patients with a baseline CD4 count less than 50/microL had a high infectious death rate in the concurrent arm . We conclude that concurrent rituximab plus infusional EPOCH is an effective regimen for HIV-associated lymphoma .

cyclophosphamide

excessive toxicity

complete response

Toxicity

infectious death

NHL

HIV-associated NHL

HIV-associated lymphoma


Efficiency of anaferon in complex therapy of genital herpes . We studied clinical efficiency and IFN-inducing activity of anaferon in chronic recurrent genital herpes with high incidence of relapses . The use of anaferon in complex therapy reduced the duration of intoxication symptoms and local symptoms , shortened the duration of the relapse , activated expression of IFN-gamma mRNA , and improved IFN-gamma-producing capacity of blood leukocytes .

anaferon

complex therapy

anaferon

anaferon

complex therapy

duration of the relapse

activated expression of IFN-gamma mRNA

genital herpes


Lack of lipotoxicity effect on { beta } -cell dysfunction in ketosis-prone type 2 diabetes . OBJECTIVE Over half of newly diagnosed obese African Americans with diabetic ketoacidosis ( DKA ) discontinue insulin therapy and go through a period of near-normoglycemia remission . This subtype of diabetes is known as ketosis-prone type 2 diabetes ( KPDM ) . RESEARCH DESIGN AND METHODS To investigate the role of lipotoxicity on beta-cell function , eight obese African Americans with KPDM , eight obese subjects with type 2 diabetes with severe hyperglycemia without ketosis ( ketosis-resistant type 2 diabetes ) , and nine nondiabetic obese control subjects underwent intravenous infusion of 20 % intralipid at 40 ml/h for 48 h. beta-Cell function was assessed by changes in insulin and C-peptide concentration during infusions and by changes in acute insulin response to arginine stimulation ( AIR ( arg ) ) before and after lipid infusion . RESULTS The mean time to discontinue insulin therapy was 11.0 +/- 8.0 weeks in KPDM and 9.6 +/- 2.2 weeks in ketosis-resistant type 2 diabetes ( P = NS ) . At remission , KPDM and ketosis-resistant type 2 diabetes had similar glucose ( 94 +/- 14 vs. 109 +/- 20 mg/dl ) , A1C ( 5.7 +/- 0.4 vs. 6.3 +/- 1.1 % ) , and baseline AIR ( arg ) response ( 34.8 +/- 30 vs. 64 +/- 69 microU/ml ) . P = NS despite a fourfold increase in free fatty acid ( FFA ) levels ( 0.4 +/- 0.3 to 1.8 +/- 1.1 mmol/l , P < 0.01 ) during the 48-h intralipid infusion ; the response to AIR ( arg ) stimulation , as well as changes in insulin and C-peptide levels , were similar among obese patients with KPDM , patients with ketosis-resistant type 2 diabetes , and nondiabetic control subjects . CONCLUSIONS Near-normoglycemia remission in obese African American patients with KPDM and ketosis-resistant type 2 diabetes is associated with a remarkable recovery in basal and stimulated insulin secretion . A high FFA level by intralipid infusion for 48 h was not associated with beta-cell decompensation ( lipotoxicity ) in KPDM patients .

lipid infusion

intralipid infusion

intralipid infusion

{ beta } -cell dysfunction

beta-cell function

beta-Cell function

insulin

C-peptide concentration

glucose

baseline AIR ( arg ) response

free fatty acid ( FFA ) levels

response to AIR ( arg ) stimulation

insulin

C-peptide levels

ketosis-prone type 2 diabetes

eight

obese

KPDM

eight

severe hyperglycemia

nine

KPDM


Stress reduction prolongs life in women with coronary disease : the Stockholm Women 's Intervention Trial for Coronary Heart Disease ( SWITCHD ) . BACKGROUND Psychosocial stress may increase risk and worsen prognosis of coronary heart disease in women . Interventions that counteract women 's psychosocial stress have not previously been presented . This study implemented a stress reduction program for women and investigated its ability to improve survival in women coronary patients . METHODS AND RESULTS Two hundred thirty-seven consecutive women patients , aged 75 years or younger , hospitalized for acute myocardial infarction , coronary artery bypass grafting , or percutaneous coronary intervention were randomized to a group-based psychosocial intervention program or usual care . Initiated 4 months after hospitalization , intervention groups of 4 to 8 women met for a total of 20 sessions that were spread over a year . We provided education about risk factors , relaxation training techniques , methods for self-monitoring and cognitive restructuring , with an emphasis on coping with stress exposure from family and work , and self-care and compliance with clinical advice . From randomization until end of follow-up ( mean duration , 7.1 years ) , 25 women ( 20 % ) in the usual care and 8 women ( 7 % ) in the stress reduction died , yielding an almost 3-fold protective effect of the intervention ( odds ratio , 0.33 ; 95 % CI , 0.15 to 0.74 ; P=0.007 ) . Introducing baseline measures of clinical prognostic factors , including use of aspirin , beta-blockers , angiotensin-converting enzyme inhibitors , calcium-channel blockers , and statins into multivariate models confirmed the unadjusted results ( P=0.009 ) . CONCLUSIONS Although mechanisms remain unclear , a group-based psychosocial intervention program for women with coronary heart disease may prolong lives independent of other prognostic factors .

Stress reduction

stress reduction program

education about risk factors

relaxation training techniques

aspirin

survival in women coronary patients .

stress reduction

use of aspirin

beta-blockers

calcium-channel blockers

statins

women

coronary disease

coronary heart disease

women

Two hundred thirty-seven

75 years

acute myocardial infarction

coronary artery bypass grafting

percutaneous coronary intervention

women

coronary heart disease


Effect of pravastatin on kidney function and urinary protein excretion in autosomal dominant polycystic kidney disease . OBJECTIVE Autosomal dominant polycystic kidney disease ( ADPKD ) is progressive , resulting in end-stage kidney failure in most patients . Experimental and clinical studies have suggested that statins may slow the progression of chronic kidney disease in general and ADPKD specifically . MATERIAL AND METHODS This randomized open-label clinical trial was conducted to assess the effect of pravastatin 20 mg on kidney function and urinary protein excretion in patients with ADPKD . Sixty patients were initially recruited but 49 of these received either pravastatin 20 mg or no treatment for 2 years . Trial visits were conducted every 3 months , assessing kidney function by estimated glomerular filtration rate and 24 h urine creatinine clearance and urinary protein excretion . RESULTS There were no significant ( p > 0.05 ) changes in markers of kidney function or urinary protein excretion between groups over the 2 years despite a significant fall in total serum cholesterol in pravastatin-treated patients ( p = 0.029 ) . CONCLUSION This trial found that taking 20 mg pravastatin for 2 years had no significant effect on kidney function or urinary protein excretion in patients with ADPKD . The lack of statistical power limits the external validity of these findings . A larger , longer duration study using a higher dose of a more potent statin is required .

pravastatin

statins

pravastatin

pravastatin

no treatment

pravastatin-treated

pravastatin

kidney function

urinary protein excretion

progression

chronic kidney disease

kidney function

glomerular filtration rate

24 h urine creatinine clearance

urinary protein excretion

changes

markers of kidney function

urinary protein excretion

kidney function

urinary protein excretion

patients with ADPKD .

Sixty patients


Randomized clinical trial of radiofrequency ablation or conventional high ligation and stripping for great saphenous varicose veins . BACKGROUND This randomized clinical trial compared early outcomes after radiofrequency ablation ( RFA ) and conventional surgery for varicose veins . METHODS Consecutive patients with symptomatic varicose veins due to isolated great saphenous vein ( GSV ) incompetence and suitable for RFA were randomized to either RFA or conventional surgery ( saphenofemoral disconnection and stripping ) . Clinical , radiological and patient-based outcomes were recorded at 1 and 5 weeks after intervention . RESULTS RFA resulted in successful obliteration of the GSV in all 47 patients . Complete above-knee stripping was unsuccessful in seven of 41 patients . RFA took longer than conventional surgery : median interquartile range 76 ( 67-84 ) versus 48 ( 39-54 ) min ; P < 0.001 . Patients returned to their normal activities significantly earlier after RFA ( median 3 ( 2-5 ) versus 12.5 ( 4-21 ) days ; P < 0.001 ) . Postoperative pain was significantly less after RFA ( median score on visual analogue scale 1.70 ( 0.50-4.30 ) versus 4.0 ( 2.35-6.05 ) ; P = 0.001 ) . Patient satisfaction , quality of life improvement and analgesic requirements significantly favoured RFA . CONCLUSION RFA took longer to perform but resulted in a significantly better early outcome than conventional surgery in suitable patients with great saphenous varicose veins .

radiofrequency ablation

conventional high ligation

radiofrequency ablation ( RFA )

RFA

RFA

RFA

RFA

RFA

patient-based outcomes

Complete above-knee stripping

returned to their normal activities

Postoperative pain

Patient satisfaction

quality of life improvement and

analgesic requirements

great saphenous varicose veins

great saphenous varicose veins


Acupuncture versus venlafaxine for the management of vasomotor symptoms in patients with hormone receptor-positive breast cancer : a randomized controlled trial . PURPOSE Vasomotor symptoms are common adverse effects of antiestrogen hormone treatment in conventional breast cancer care . Hormone replacement therapy is contraindicated in patients with breast cancer . Venlafaxine ( Effexor ) , the therapy of choice for these symptoms , has numerous adverse effects . Recent studies suggest acupuncture may be effective in reducing vasomotor symptoms in menopausal women . This randomized controlled trial tested whether acupuncture reduces vasomotor symptoms and produces fewer adverse effects than venlafaxine . PATIENTS AND METHODS Fifty patients were randomly assigned to receive 12 weeks of acupuncture ( n = 25 ) or venlafaxine ( n = 25 ) treatment . Health outcomes were measured for up to 1 year post-treatment . RESULTS Both groups exhibited significant decreases in hot flashes , depressive symptoms , and other quality-of-life symptoms , including significant improvements in mental health from pre- to post-treatment . These changes were similar in both groups , indicating that acupuncture was as effective as venlafaxine . By 2 weeks post-treatment , the venlafaxine group experienced significant increases in hot flashes , whereas hot flashes in the acupuncture group remained at low levels . The venlafaxine group experienced 18 incidences of adverse effects ( eg , nausea , dry mouth , dizziness , anxiety ) , whereas the acupuncture group experienced no negative adverse effects . Acupuncture had the additional benefit of increased sex drive in some women , and most reported an improvement in their energy , clarity of thought , and sense of well-being . CONCLUSION Acupuncture appears to be equivalent to drug therapy in these patients . It is a safe , effective and durable treatment for vasomotor symptoms secondary to long-term antiestrogen hormone use in patients with breast cancer .

Acupuncture

venlafaxine

antiestrogen hormone treatment

Hormone replacement therapy

Venlafaxine

acupuncture

acupuncture

venlafaxine

acupuncture

venlafaxine

acupuncture

venlafaxine

venlafaxine

acupuncture

venlafaxine

acupuncture

Acupuncture

Acupuncture

antiestrogen hormone

vasomotor symptoms

Vasomotor symptoms

vasomotor symptoms

vasomotor symptoms

Health outcomes

hot flashes

depressive symptoms

quality-of-life symptoms

mental health

hot flashes

nausea

dry mouth

dizziness

anxiety

sex drive

energy

clarity of thought

sense of well-being

hormone receptor-positive breast cancer

breast cancer

menopausal

Fifty

breast cancer


A phase II study of cetuximab , capecitabine and radiotherapy in neoadjuvant treatment of patients with locally advanced resectable rectal cancer . BACKGROUND Neoadjuvant chemoradiotherapy ( CRT ) reduces local tumor recurrence in locally advanced rectal cancer ( LARC ) . This phase II study assessed neoadjuvant cetuximab with capecitabine-based CRT in LARC . METHODS Patients with stage II/III LARC received capecitabine 1250 mg/m ( 2 ) twice daily for 2 weeks followed by intravenous cetuximab 400 mg/m ( 2 ) at week 3 , then weekly intravenous 250 mg/m ( 2 ) cetuximab plus CRT including capecitabine 825 mg/m ( 2 ) twice daily ( including weekends during radiotherapy ) with radiotherapy of 45 Gy ( 25 x 1.8 Gy ) , 5 days a week for 5 weeks . Total mesorectal excision was scheduled 4-6 weeks following completion of CRT . The primary endpoint was pathological complete response ( pCR ) . RESULTS Thirty-seven patients were eligible for safety and efficacy . TMN staging at baseline was : T4N2 , 11 % ; T3N2 , 40 % ; T2N2 , 3 % ; T3N1 , 35 % ; T2N1 , 3 % and T3N0 8 % . The most common adverse events included , grade 1/2 acneiform skin rash ( 86 % ) , and grade 3 radiodermatitis , ( 16 % ) , diarrhea ( 11 % ) and hypersensitivity ( 5 % ) . pCR was achieved in 3 patients ( 8 % ) . Overall- , T- and N-downstaging rates were 73 % , 57 % and 81 % respectively . Total sphincter preservation rate was 76 % , and 53 % in 17 patients whose tumors were located within 5 cm from the anal verge . Non-fatal perioperative complications occurred in 13 patients ( 35 % ) with delayed wound healing occurring in 6 patients ( 16 % ) . One death was recorded due to sepsis following colonic necrosis . CONCLUSION Neoadjuvant cetuximab with capecitabine-based CRT is tolerable in patients with resectable LARC . Whilst the pCR rate was similar to recent reports , a high pathological downstaging rate was achieved .

cetuximab

capecitabine

radiotherapy

chemoradiotherapy ( CRT )

capecitabine

intravenous cetuximab

cetuximab plus CRT

capecitabine

radiotherapy

cetuximab with capecitabine-based CRT

pathological complete response ( pCR )

safety and efficacy

TMN

grade 1/2 acneiform skin rash

grade 3 radiodermatitis

diarrhea

hypersensitivity

pCR

T- and N-downstaging rates

Total sphincter preservation rate

Non-fatal perioperative complications

delayed wound healing

stage II/III LARC

Thirty-seven

resectable LARC


The effectiveness of physical activity monitoring and distance counselling in an occupational health setting -- a research protocol for a randomised controlled trial ( CoAct ) . BACKGROUND The CoAct ( Cocreating Activity ) study is investigating a novel lifestyle intervention , aimed at the working population , with daily activity monitoring and distance counselling via telephone and secure web messages . The main purpose of this study is to evaluate the effectiveness of lifestyle counselling on the level of physical activity in an occupational health setting . The purposes include also analysing the potential effects of changes in physical activity on productivity at work and sickness absence , and healthcare costs . This article describes the design of the study and the participant flow until and including randomization . METHODS/DESIGN CoAct is a randomised controlled trial with two arms : a control group and intervention group with daily activity monitoring and distance counselling . The intervention focuses on lifestyle modification and takes 12 months . The study population consists of volunteers from 1100 eligible employees of a Finnish insurance company . The primary outcomes of this study are change in physical activity measured in MET minutes per week , work productivity and sickness absence , and healthcare utilisation . Secondary outcomes include various physiological measures . Cost-effectiveness analysis will also be performed . The outcomes will be measured by questionnaires at baseline , after 6 , 12 , and 24 months , and sickness absence will be obtained from the employer 's registers . DISCUSSION No trials are yet available that have evaluated the effectiveness of daily physical activity monitoring and distance counselling in an occupational health setting over a 12 month period and no data on cost-effectiveness of such intervention are available . TRIAL REGISTRATION ClinicalTrials.gov identifier : NCT00994565 .

lifestyle intervention

control

effectiveness

effectiveness

physical activity

productivity at work

sickness absence

healthcare costs

various physiological measures

Cost-effectiveness

questionnaires

sickness absence

cost-effectiveness

working

volunteers

1100 eligible employees


Evaluation of a new wound closure device for linear surgical incisions : 3M Steri-Strip S Surgical Skin Closure versus subcuticular closure . BACKGROUND Technological innovations are often adopted before scientific comparison to an accepted standard . The authors ' study compared suture with a new coaptive film device , 3M Steri-Strip S Surgical Skin Closure , on linear incisions . METHODS Patients undergoing Wise-pattern breast reduction or abdominal procedures had paired incisions randomly assigned to Steri-Strip S or suture closure . Key outcome measures were closure time , patient comfort , and scar quality at 6 months by patients and surgeons using a new scar evaluation tool , visual assessment of linear scars . Statistical differences between the two closure techniques were assessed by Wilcoxon signed rank test . RESULTS Of 59 patients , eight were excluded from randomization ( a surgeon judged Steri-Strip S to be a nonviable closure technique for mismatched wound edges ) . Fifty-one patients ( breast , n = 24 ; abdomen , n = 27 ) were randomized . Operative time with Steri-Strip S for breast was 2.0 minutes ( SD = 1.1 ) versus suture closure at 4.6 minutes ( SD = 1.5 ; p < 0.001 ) . Similarly , Steri-Strip S versus suture for the abdomen was faster ( p < 0.001 ; 4.9 minutes , SD = 2.3 versus 10.1 minutes , SD = 3.4 ) . Comfort scores did not differ between closures [ 5.8 ( SD = 2.7 ) versus 6.9 ( SD = 2.0 ) , respectively , on breast ( p = 0.142 ) and 7.7 ( SD = 1.8 ) versus 7.7 ( SD = 2.3 ) on abdomen ( p = 0.903 ) ] . Complication rates did not differ between closure types . Patients ' visual assessment of linear scars rating of breasts was 3.8 ( SD = 2.9 ) for Steri-Strip S and better at 2.6 ( SD = 2.9 ) for suture ( p = 0.008 ) . One surgeon rated breast Steri-Strip S scars worse than suture scars ( 4.3 versus 3.7 ; p = 0.014 ) . For abdominal scars , there was no difference in the patient or surgeon ratings . CONCLUSIONS Steri-Strip S permits faster wound closure than suture . On the basis of patient reports of comfort and scar quality , surgeons increase efficiency and maintain quality with the use of Steri-Strip S on abdominal wounds but not on breast wounds .

new coaptive film device

Steri-Strip S or suture closure

new scar evaluation tool

Steri-Strip

S

suture closure

Steri-Strip S

suture

closure time

patient comfort

scar quality

Operative time

Complication rates

wound closure

comfort and scar quality

efficiency

quality

Fifty-one


Improved adherence with once-daily versus twice-daily dosing of mometasone furoate administered via a dry powder inhaler : a randomized open-label study . BACKGROUND Poor adherence with prescribed asthma medication is a major barrier to positive treatment outcomes . This study was designed to determine the effect of a once-daily administration of mometasone furoate administered via a dry powder inhaler ( MF-DPI ) on treatment adherence compared with a twice-daily administration . METHODS This was a 12-week open-label study designed to mimic an actual clinical setting in patients > or=12 years old with mild-to-moderate persistent asthma . Patients were randomized to receive MF-DPI 400 microg once-daily in the evening or MF-DPI 200 microg twice-daily . Adherence was assessed primarily using the number of actual administered doses reported from the device counter divided by the number of scheduled doses . Self-reports were also used to determine adherence . Health-related quality of life , healthcare resource utilization , and days missed from work or school were also reported . RESULTS 1233 patients were randomized . The mean adherence rates , as measured by the automatic dose counter , were significantly better ( P < 0.001 ) with MF-DPI 400 microg once-daily in the evening ( 93.3 % ) than with MF-DPI 200 microg twice-daily ( 89.5 % ) . Mean adherence rates based on self-reports were also significantly better ( P < 0.001 ) with MF-DPI 400 microg QD PM ( 97.2 % ) than with MF-DPI 200 microg twice-daily ( 95.3 % ) . Adherence rates were lower in adolescents ( 12-17 years old ) . Health-related quality of life improved by 20 % in patients using MF-DPI once-daily in the evening and by 14 % in patients using MF-DPI twice-daily . Very few ( < 8 % ) patients missed work/school . CONCLUSION Mean adherence rates were greater with a once-daily dosing regimen of MF-DPI than with a twice-daily dosing regimen.This trial was completed prior to the ISMJE requirements for trial registration .

mometasone furoate

mometasone furoate

MF-DPI 200 microg twice-daily

MF-DPI

adherence

Adherence

actual administered doses

Health-related quality of life

healthcare resource utilization

days missed from work or school

mean

adherence rates

Mean

adherence rates

Adherence rates

Health-related quality of life

missed work/school

adherence rates

> or=12 years old

mild-to-moderate persistent asthma


Paracetamol reduces postoperative pain and rescue analgesic demand after robot-assisted endoscopic thyroidectomy by the transaxillary approach . BACKGROUND Postoperative pain following endoscopic thyroidectomy , although less severe than after open methods , is still a source of marked discomfort and surgical stress . This clinical trial was conducted to determine if repeated intravenous paracetamol could decrease postoperative pain and rescue analgesic requirements after robot-assisted endoscopic thyroidectomy via the transaxillary approach . MATERIALS AND METHODS This prospective , randomized , double-blinded , and placebo-controlled study enrolled 124 women 21-60 years of age who were scheduled for elective gasless robot-assisted endoscopic thyroidectomy via the transaxillary approach . The patients were given placebo or 1 g of paracetamol as a 100 ml solution infused over 15 min 1 h before the induction of anesthesia , and then at 6-h intervals for the following 24 h. RESULTS Postoperative pain scores were significantly lower at 1 , 3 , 6 , and 24 h after surgery in the paracetamol group than in the placebo group . Significantly fewer patients in the paracetamol group received rescue analgesics compared to the placebo group ( 9.5 % vs. 65.6 % , respectively ) . First analgesic time was similar in the two groups . Postoperative nausea ( 44.3 % vs. 22.2 % ) and vomiting ( 21.3 % vs. 6.3 % ) were more frequent in the placebo group than in the paracetamol group . Other postoperative side effects , including sedation , confusion , and pruritus , were similar in the two groups . CONCLUSIONS We concluded that repeated administration of 1 g of intravenous paracetamol over 24 h is easy , effective , safe , and well tolerated for pain management in patients with moderate to severe postoperative pain after gasless robot-assisted endoscopic thyroidectomy performed via the transaxillary approach .

Paracetamol

rescue analgesic

endoscopic thyroidectomy

intravenous paracetamol

robot-assisted endoscopic thyroidectomy

transaxillary approach

placebo-controlled

transaxillary approach

placebo

paracetamol

anesthesia

paracetamol

placebo

paracetamol

rescue analgesics

placebo

analgesic

placebo

paracetamol

intravenous paracetamol

transaxillary approach

pain and rescue analgesic demand

Postoperative pain scores

analgesic time

Postoperative nausea

vomiting

sedation , confusion , and pruritus

124 women

moderate to severe postoperative pain


A randomized controlled study of parent-assisted Children 's Friendship Training with children having autism spectrum disorders . This study evaluated Children 's Friendship Training ( CFT ) , a manualized parent-assisted intervention to improve social skills among second to fifth grade children with autism spectrum disorders . Comparison was made with a delayed treatment control group ( DTC ) . Targeted skills included conversational skills , peer entry skills , developing friendship networks , good sportsmanship , good host behavior during play dates , and handling teasing . At post-testing , the CFT group was superior to the DTC group on parent measures of social skill and play date behavior , and child measures of popularity and loneliness , At 3-month follow-up , parent measures showed significant improvement from baseline . Post-hoc analysis indicated more than 87 % of children receiving CFT showed reliable change on at least one measure at post-test and 66.7 % after 3 months follow-up .

Children 's Friendship Training ( CFT )

manualized parent-assisted intervention

delayed treatment control group ( DTC )

CFT

handling teasing

social skill and play date behavior

popularity and loneliness

children

autism spectrum disorders

second to fifth grade children

autism spectrum disorders .


Preoperative lanreotide treatment in acromegalic patients with macroadenomas increases short-term postoperative cure rates : a prospective , randomised trial . OBJECTIVE To investigate whether 4-month preoperative lanreotide treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with macroadenomas . DESIGN A prospective , randomised study . METHODS After a baseline evaluation , patients were randomly assigned to 4-month preoperative treatment with lanreotide ( starting with 30 mg/2 weeks i.m . and increasing to 30 mg/week i.m . at week 8 if mean GH > 2.5 microg/l on GH day curves ; pretreatment group , Group 1 ) or to transsphenoidal surgery ( direct surgery group , Group 2 ) . Cure was evaluated 4 months postoperatively primarily by fasting IGF1 less than or equal to age-adjusted upper limit of normal . RESULTS A pool of 108 patients was randomly divided into two groups . Five patients in each group were lost to follow-up during the study period , so 49 patients in each group were analysed . At baseline , no difference was observed between the two groups . Cure was established in 24 of 49 ( 49.0 % , 95 % confidence interval ( CI ) , 35.0-63.0 % ) pretreated patients ( Group 1 ) versus 9 of 49 ( 18.4 % , 95 % CI , 7.6-29.2 % ) direct surgery patients ( Group 2 ; P=0.001 ) . Surgical morbidity was recorded in 12 patients ( 12.2 % ) and was similar in Group 1 and 2 patients ( 14.3 and 10.2 % respectively ; P=0.538 ) . The postoperative hospital stay was similar between groups : being 4.5+/-1.6 days in Group 1 vs 4.8+/-1.9 days in Group 2 ( P=0.328 ) . CONCLUSIONS Pretreatment with lanreotide before transsphenoidal surgery improves surgical cure rates in patients with GH-secreting pituitary macroadenomas . Pretreatment does not affect surgical complications or duration of hospital stay ( ClinicalTrials.gov number , NCT00993356 ) .

lanreotide

lanreotide

transsphenoidal surgery

lanreotide

surgical cure rate

Cure

Cure

Surgical morbidity

postoperative hospital stay

surgical cure rates

surgical complications

duration of hospital stay

acromegalic patients with macroadenomas

108 patients

49 patients in each group


Evidence for poorer outcome in patients with severe negative trauma-related cognitions receiving prolonged exposure plus cognitive restructuring : implications for treatment matching in posttraumatic stress disorder . In the current article , we address the existing assumption in the literature on cognitive behavioral treatment of PTSD that patients with severe negative trauma-related cognitions would benefit more from a treatment package that includes exposure and cognitive techniques compared with a treatment that includes exposure only . To test this assumption , 54 PTSD patients were randomized to prolonged exposure therapy or prolonged exposure therapy plus cognitive restructuring . Contrary to expectations , findings revealed that patients characterized by more severe pretreatment trauma-related cognitions ( and more severe pretreatment PTSD symptoms ) fared slightly worse in treatment combining exposure and cognitive restructuring . However , there was no relationship between pre- and post-treatment measures of negative cognitions and PTSD symptoms in the exposure alone group . The implications of these findings for examining Person X Treatment interactions and the efficacy of combining treatments for PTSD are discussed .

prolonged exposure

cognitive restructuring

cognitive behavioral treatment

exposure only .

prolonged exposure therapy

exposure and cognitive restructuring .

exposure alone

and PTSD symptoms

efficacy


Monitoring acute effects on athletic performance with mixed linear modeling . UNLABELLED There is a need for a sophisticated approach to track athletic performance and to quantify factors affecting it in practical settings . PURPOSE To demonstrate the application of mixed linear modeling for monitoring athletic performance . METHODS Elite sprint and middle-distance swimmers ( three females and six males ; aged 21-26 yr ) performed 6-13 time trials in training and competition in the 9 wk before and including Olympic-qualifying trials , all in their specialty event . We included a double-blind , randomized , diet-controlled crossover intervention , in which the swimmers consumed caffeine ( 5 mg x kg ( -1 ) body mass ) or placebo . The swimmers also knowingly consumed varying doses of caffeine in some time trials . We used mixed linear modeling of log-transformed swim time to quantify effects on performance in training versus competition , in morning versus evening swims , and with use of caffeine . Predictor variables were coded as 0 or 1 to represent absence or presence , respectively , of each condition and were included as fixed effects . The date of each performance test was included as a continuous linear fixed effect and interacted with the random effect for the athlete to represent individual differences in linear trends in performance . RESULTS Most effects were clear , owing to the high reliability of performance times in training and competition ( typical errors of 0.9 % and 0.8 % , respectively ) . Performance time improved linearly by 0.8 % per 4 wk . The swimmers performed substantially better in evenings versus mornings and in competition versus training . A 100-mg dose of caffeine enhanced performance in training and competition by approximately 1.3 % . There were substantial but unclear individual responses to training and caffeine ( SD of 0.3 % and 0.8 % , respectively ) . CONCLUSIONS Mixed linear modeling can be applied successfully to monitor factors affecting performance in a squad of elite athletes .

diet-controlled crossover intervention

caffeine

placebo

caffeine

effects on performance

effects

Performance time

performed substantially better

performance in training and competition

three

females

six

males

aged 21-26


PROCLAIM : pilot study to examine the effects of clopidogrel on inflammatory markers in patients with metabolic syndrome receiving low-dose aspirin . Metabolic syndrome is associated with intravascular inflammation , as determined by increased levels of inflammatory biomarkers and an increased risk of ischemic atherothrombotic events . Evidence suggests that atherothrombosis and intravascular inflammation share predictive biomarkers , including high-sensitivity C-reactive protein , CD40 ligand , P-selectin , and N-terminal pro-brain natriuretic peptide . Patients who had metabolic syndrome were randomized to receive clopidogrel 75 mg/day plus aspirin 81 mg/day ( n = 89 ) or placebo plus aspirin 81 mg/day ( n = 92 ) for 9 weeks to assess the efficacy of each treatment in suppression of inflammatory markers . Change from baseline in the levels of high-sensitivity C-reactive protein , CD40 ligand , P-selectin , and N-terminal pro-brain natriuretic peptide at 6 weeks was assessed to evaluate each treatment . There was a significant difference at Week 6 in model-adjusted CD40-ligand levels in favor of clopidogrel plus aspirin compared with placebo plus aspirin in both the intent-to-treat population ( difference between least-squares means = -186.5 ; 95 % confidence interval , -342.3 to -30.8 ; P = 0.02 ) and the per-protocol population ( P = 0.05 ) . No significant differences were observed between the treatment arms for high-sensitivity C-reactive protein , P-selectin , and N-terminal pro-brain natriuretic peptide . There were no deaths or serious adverse events in either treatment arm . Data from this study suggest that clopidogrel can decrease the expression of the CD40-ligand biomarker .

clopidogrel

aspirin

clopidogrel 75 mg/day

aspirin 81 mg/day

placebo

aspirin 81 mg/day

clopidogrel

aspirin

placebo

aspirin

clopidogrel

model-adjusted CD40-ligand levels

high-sensitivity C-reactive protein

P-selectin

deaths

serious adverse events

Patients who had metabolic syndrome


Changes in quality of life and sexual health are associated with low-dose peginterferon therapy and disease progression in patients with chronic hepatitis C. BACKGROUND Primary analysis of the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis ( HALT-C ) Trial showed long-term peginterferon therapy did not reduce complications in patients with chronic hepatitis C and advanced fibrosis or cirrhosis . AIM To assess the effects of long-term peginterferon therapy and disease progression on health-related quality of life ( HRQOL ) , symptoms and sexual health in HALT-C patients . METHODS A total of 517 HALT-C patients received peginterferon alfa-2a ( 90 microg/week ) ; 532 received no additional treatment for 3.5 years . Patients were followed up for outcomes of death , hepatocellular carcinoma and hepatic decompensation . Sexual health , SF-36 scores and symptoms were serially assessed by repeated-measures analyses of covariance . RESULTS Patients with cirrhosis ( n = 427 ) reported lower general well-being and more fatigue ( P < 0.001 ) than patients with fibrosis ( n = 622 ) . Physical scores declined significantly over time , independent of treatment , and patients with cirrhosis reported lower scores . Vitality scores were lower in those with cirrhosis , and treated patients experienced a greater decline over time than untreated patients ; HRQOL rebounded after treatment ended . Patients with a clinical outcome had significantly greater declines in all SF-36 and symptom scores . Among men , Sexual Health scores were significantly worse in treated patients and in those with a clinical outcome . CONCLUSION Clinical progression of chronic hepatitis C and maintenance peginterferon therapy led to worsening of symptoms , HRQOL and , in men , sexual health in a large patient cohort followed up over 4 years ( NCT00006164 ) .

peginterferon therapy

peginterferon therapy

peginterferon therapy

peginterferon alfa-2a

no additional treatment

peginterferon therapy

quality of life

sexual health

death

hepatocellular carcinoma

hepatic decompensation

Sexual health

SF-36 scores

general well-being

fatigue

Physical scores

Vitality scores

Sexual Health scores

symptoms

HRQOL

sexual health

chronic hepatitis C.

Hepatitis C

Cirrhosis

HALT-C

chronic hepatitis C

advanced fibrosis

cirrhosis

HALT-C

cirrhosis

fibrosis

men


[ Evaluation of Stepping Stones Triple P : Interims analysis of the Stepping-Stones-SPC-Multicentric Study ] . Stepping Stones Triple P is a behavioural parenting training for families with a handicapped child , which has already been successfully evaluated in its country of origin , Australia . Within a multicentric study of several Social Pediatric Centers ( SPCs ) and further clinics/institutions in Germany , it has been established as a group parenting training ( 3-7 families per training ) . Statistical analysis proved significant effects concerning dysfunctional parenting , parental stress and child behaviour problems as well as little side effects and a positive acceptance of stepping stones by the families .

Stepping Stones Triple P

group parenting training

effects

little side effects

positive acceptance

child


Influence of sentinel lymph node tumor burden on survival in melanoma . BACKGROUND Completion lymph node dissection ( CLND ) is the standard procedure for patients with positive sentinel lymph nodes ( SLN ) . With extensive pathological workup , increased numbers of small metastatic deposits are detected in SLN . This study evaluated the prognostic significance of SLN metastatic deposits < or = 0.2 mm in patients treated in a referral cancer center in Brazil . METHODS Patients with stage I/II melanoma , consecutively submitted to a SLN procedure by the same surgeon from 2000 to 2006 , were evaluated . All positive SLN and randomly selected negative cases were reviewed by two pathologists . Different prognostic factors and SLN tumor burden were recorded . Additional positive non-SLN after CLND , and disease outcome were evaluated . RESULTS Of 381 patients who underwent SLN biopsy , 103 ( 27 % ) were positive . The mean/median Breslow tumor thickness in the overall group was 3.4/2.0 mm and in the SLN positive patients was 5.72/4.0 mm . Among these patients , 48 ( 47 % ) had metastatic deposits > 2 mm ( macrometastasis ) , 49 ( 47 % ) had metastatic deposits < or =2 mm but > 0.2 mm ( micrometastasis ) , and 6 ( 6 % ) had metastatic deposits < or =0.2 mm ( submicrometastasis ) . Additional positive non-SLN were detected in 29 % of patients with macrometastasis , in 25 % of patients with micrometastasis , and in 0 % of patients with submicrometastases . At median follow-up of 35 months , the estimated 3-year overall survival was 92 % for negative SLN , 64 % for micrometastases , 53 % for macrometastases , and 100 % for submicrometastases ( P < 0.001 ) . CONCLUSION In the present study , patients with SLN metastatic deposits < or =0.2 mm had no additional positive non-SLNs , and no recurrences or deaths were recorded , suggesting that their prognosis is equivalent to that of patients with negative SLN .

SLN procedure

tumor thickness

melanoma

positive sentinel lymph nodes

melanoma

SLN biopsy


Epirubicin and cyclophosphamide versus epirubicin and docetaxel as first-line therapy for women with metastatic breast cancer : final results of a randomised phase III trial . BACKGROUND This randomised phase III trial was carried out to compare the efficacy and safety of epirubicin and cyclophosphamide ( EC ) with epirubicin and docetaxel ( Taxotere ) ( ED ) as first-line chemotherapy for metastatic breast cancer . PATIENTS AND METHODS Patients ( n = 240 ) were randomly assigned to receive either ED ( epirubicin 75 mg/m ( 2 ) and docetaxel 75 mg/m ( 2 ) ) or EC ( epirubicin 90 mg/m ( 2 ) and cyclophosphamide 600 mg/m ( 2 ) ) . The primary end point was objective response rate ( ORR ) . Secondary end points were progression-free survival ( PFS ) , overall survival ( OS ) , and safety . RESULTS ORR for patients randomly assigned to receive EC and ED were 42 % and 47 % , respectively ( P = 0.63 ) . Median PFS [ 10.1 versus 10.3 months ; hazard ratio ( HR ) 0.98 ; log-rank P = 0.38 ] and OS ( 19.9 versus 30.0 months ; HR 0.663 ; log-rank P = 0.21 ) were comparable in both arms . Although grade 3/4 leucopenia occurred more frequently with ED ( 81 % versus 73 % ; P = 0.01 ) , there were no significant differences in the incidence of febrile neutropenia and grade 3/4 infections . Grade 3/4 non-haematologic toxicity was infrequent in both arms . Congestive heart failure was observed in one patient in each arm . CONCLUSION In this randomised trial , no differences in the efficacy study end points were observed between the two treatment arms .

Epirubicin

cyclophosphamide

epirubicin

docetaxel

epirubicin

cyclophosphamide ( EC )

epirubicin

docetaxel ( Taxotere ) ( ED )

ED ( epirubicin

docetaxel

EC ( epirubicin

cyclophosphamide

EC

ED

ED

objective response rate ( ORR )

progression-free survival ( PFS )

overall survival ( OS )

safety .

ORR

Median PFS

OS

grade 3/4 leucopenia

febrile neutropenia

grade 3/4 infections

Grade 3/4 non-haematologic toxicity

Congestive heart failure

women

with metastatic breast cancer

metastatic breast cancer

Patients ( n = 240


A randomized clinical trial of the efficacy of scheduled dosing of acetaminophen and hydrocodone for the management of postoperative pain in children after tonsillectomy . OBJECTIVES To determine the effectiveness of around-the-clock ( ATC ) analgesic administration , with or without nurse coaching , compared with standard care with as needed ( PRN ) dosing in children undergoing outpatient tonsillectomy . METHODS Children 6 to 15 years of age were randomized to receive acetaminophen and hydrocodone ( 167 mg/2.5 mg/5 mL ) for 3 days after surgery : Group A ( N=39 ) -every 4 hours PRN , with standard postoperative instructions ; Group B ( N=34 ) -every 4 hours ATC , with standard postoperative instructions , without nurse coaching ; and Group C ( N=40 ) -every 4 hours ATC , with standard postoperative instructions , with coaching . Parents completed a medication log , and recorded the presence and severity of opioid-related adverse effects and children 's reports of pain intensity using a 0 to 10 numeric rating scale . RESULTS No differences were found in analgesic administration or pain intensity scores between the 2 ATC groups . Therefore , they were combined for comparison with the PRN group . Children in the ATC group received more analgesic than those in the PRN group ( P < 0.0001 ) . Children in the PRN group had higher pain intensity scores compared to children in the ATC group , both at rest ( P=0.017 ) and with swallowing ( P=0.017 ) . Pain intensity scores for both groups were higher in the morning compared with the evening ( P < 0.0001 ) . With the exception of constipation , scheduled analgesic dosing did not increase the frequency or severity of opioid-related adverse effects . DISCUSSION Scheduled dosing of acetaminophen and hydrocodone is more effective than PRN dosing in reducing pain intensity in children after tonsillectomy . Nurse coaching does not impact parent 's adherence to ATC dosing .

acetaminophen and hydrocodone

acetaminophen and hydrocodone

without nurse coaching

with coaching

efficacy

effectiveness

Parents completed a

medication log

, and recorded the

pain intensity scores

analgesic

pain intensity scores

Pain intensity scores

constipation

postoperative pain

children

tonsillectomy

children

6 to 15 years of age


Pazopanib in locally advanced or metastatic renal cell carcinoma : results of a randomized phase III trial . PURPOSE Pazopanib is an oral angiogenesis inhibitor targeting vascular endothelial growth factor receptor , platelet-derived growth factor receptor , and c-Kit . This randomized , double-blind , placebo-controlled phase III study evaluated efficacy and safety of pazopanib monotherapy in treatment-naive and cytokine-pretreated patients with advanced renal cell carcinoma ( RCC ) . PATIENTS AND METHODS Adult patients with measurable , locally advanced , and/or metastatic RCC were randomly assigned 2:1 to receive oral pazopanib or placebo . The primary end point was progression-free survival ( PFS ) . Secondary end points included overall survival , tumor response rate ( Response Evaluation Criteria in Solid Tumors ) , and safety . Radiographic assessments of tumors were independently reviewed . Results Of 435 patients enrolled , 233 were treatment naive ( 54 % ) and 202 were cytokine pretreated ( 46 % ) . PFS was significantly prolonged with pazopanib compared with placebo in the overall study population ( median , PFS 9.2 v 4.2 months ; hazard ratio [ HR ] , 0.46 ; 95 % CI , 0.34 to 0.62 ; P < .0001 ) , the treatment-naive subpopulation ( median PFS 11.1 v 2.8 months ; HR , 0.40 ; 95 % CI , 0.27 to 0.60 ; P < .0001 ) , and the cytokine-pretreated subpopulation ( median PFS , 7.4 v 4.2 months ; HR , 0.54 ; 95 % CI , 0.35 to 0.84 ; P < .001 ) . The objective response rate was 30 % with pazopanib compared with 3 % with placebo ( P < .001 ) . The median duration of response was longer than 1 year . The most common adverse events were diarrhea , hypertension , hair color changes , nausea , anorexia , and vomiting . There was no evidence of clinically important differences in quality of life for pazopanib versus placebo . CONCLUSION Pazopanib demonstrated significant improvement in PFS and tumor response compared with placebo in treatment-naive and cytokine-pretreated patients with advanced and/or metastatic RCC .

Pazopanib

Pazopanib

oral angiogenesis inhibitor

placebo-controlled

pazopanib monotherapy

cytokine-pretreated

oral pazopanib

placebo

pazopanib

placebo

pazopanib

placebo

pazopanib

placebo

Pazopanib

placebo

cytokine-pretreated

progression-free survival ( PFS )

overall survival

tumor response rate

safety

PFS

objective response rate

median duration of response

diarrhea

hypertension

hair color changes

nausea

anorexia

vomiting

renal cell carcinoma

RCC


A comparative study of the effects of local estrogen with or without local testosterone on vulvovaginal and sexual dysfunction in postmenopausal women . INTRODUCTION A significant number of postmenopausal women suffer from distressing problems because of urogenital atrophy secondary to the decline in circulating estrogen levels . Treatment with topical hormones may provide relief in such women when used judiciously . AIM To study the effects of local estrogen with or without local testosterone on urogenital and sexual health in postmenopausal women . METHODS Seventy-five postmenopausal women symptomatic for urogenital atrophy and sexual dysfunction were randomly divided into two study groups and one control group . The women in study group 1 received local estrogen cream ; study group 2 received local estrogen and testosterone cream ; the control group received nonhormonal lubricant KY gel for 12 weeks . The urogenital and sexuality score , along with the vaginal health index and the vaginal maturation index ( VMI ) , was calculated at the beginning of therapy and 12 weeks later . MAIN OUTCOME MEASURES Changes in the urogenital and sexuality score along with vaginal health index and VMI . RESULTS After 12 weeks of therapy , there was a significant improvement in all the four study parameters , which correlated well with the improvement in symptoms of urogenital atrophy and sexual dysfunction in both the study groups as compared with the control group . Improvement in sexuality score was greatest with combined estrogen-androgen therapy . There were no adverse effects and the therapies were well accepted without any compliance issue . CONCLUSION Local estrogen either alone or with androgen is highly effective in relieving symptoms of urogenital atrophy and in improving sexual function in symptomatic postmenopausal women .

testosterone

topical hormones

local testosterone

received local estrogen cream

local estrogen and testosterone cream ;

Local estrogen

vulvovaginal and sexual dysfunction

urogenital and sexual health

urogenital and sexuality score

sexuality score

adverse effects

urogenital atrophy

improving sexual function

postmenopausal women

postmenopausal women .

study groups

control group .

symptomatic postmenopausal women .


Efficacy of omeprazole versus high-dose famotidine for prevention of exercise-induced gastritis in racing Alaskan sled dogs . BACKGROUND Omeprazole and famotidine both reduce severity of exercise-induced gastritis , but administering famotidine is easier than administering omeprazole during racing competition . HYPOTHESIS Famotidine is more efficacious than no treatment in reducing severity of exercise-induced gastritis ; and high-dose famotidine is more efficacious than omeprazole in reducing severity of exercise-induced gastritis . ANIMALS Experiment 1 : Randomized placebo-controlled study , 36 sled dogs ( 3-8 years ) ; Experiment 2 : Randomized positive-control study , 52 sled dogs ( 2-8 years ) . METHODS Experiment 1 : Equal numbers of dogs randomly assigned to famotidine ( 20 mg q24h ) or no treatment groups . Gastroscopy was performed 24 hours after the dogs ran 330 miles . Mucosal appearance was blindly scored by previously described scoring system . Experiment 2 : Equal numbers of dogs randomly assigned to omeprazole ( 20 mg q24h ) or high-dose famotidine ( 40 mg q12h ) groups . Gastroscopy was performed 48 hours before and 24 hours after the dogs ran 300 miles . Mucosal appearance was blindly scored by previously described scoring system . RESULTS Famotidine reduced the prevalence of clinically relevant , exercise-induced gastric lesions compared with no treatment ( 7/16 versus 11/16 , P = .031 ) . Compared with high-dose famotidine , omeprazole significantly decreased the severity ( 0.4 versus 1.2 , P = .0002 ) and prevalence ( 2/23 versus 7/21 , P = .049 ) of gastric lesions . CONCLUSIONS AND CLINICAL RELEVANCE Although famotidine provides some benefit in the prevention of exercise-induced gastric lesions , omeprazole is superior to famotidine in preventing gastritis in dogs running 300 miles . Routine administration of omeprazole is recommended to prevent stress-associated gastric disease in exercising and racing Alaskan sled dogs .

omeprazole

high-dose famotidine

Omeprazole

famotidine

famotidine

no treatment

omeprazole

famotidine

Famotidine

famotidine

omeprazole

omeprazole

exercise-induced gastritis

Mucosal appearance

Mucosal appearance

severity

prevalence

gastric lesions .

exercise-induced gastric lesions

gastritis

stress-associated gastric disease

racing Alaskan sled dogs


Effect of milrinone on short-term outcome of patients with myocardial dysfunction undergoing coronary artery bypass graft : A randomized controlled trial . BACKGROUND Myocardial dysfunction needing inotropic support is a typical complication after on-pump cardiac surgery . In this study , we evaluate the effect of milrinone on patients with ventricular dysfunction undergoing coronary artery bypass graft ( CABG ) . METHODS Seventy patients with impaired left ventricular function [ left ventricular ejection fraction ( LVEF ) < 35 % ] undergoing on-pump CABG were enrolled . Patients were randomized to receive either an intraoperative bolus of milrinone ( 50 microg/kg ) or saline as placebo followed by a 24-hour infusion of each agent ( 0.5 microg/kg/min ) . Hemodynamic parameters and transthoracic echocardiographic measurement of systolic and diastolic functions were the variables evaluated . RESULTS Serum levels of creatine phosphokinase ( CPK ) , the MB isoenzyme of creatine kinase ( CK-MB ) , occurrence of myocardial ischemia or infarction , and mean duration of using inotropic agents were significantly lower in the milrinone group ( p < 0.05 ) . There were no significant differences between the two groups regarding the development of ventricular arrhythmia , duration of cardiopulmonary bypass , intra-aortic balloon pump and inotropic support requirement , duration of mechanical ventilation , duration of intensive care unit stay and mortality rate . Although mean pre-operative LVEF was significantly lower in the milrinone group , there was no significant difference between post-operative LVEFs . CONCLUSIONS We suggest that perioperative administration of milrinone in patients undergoing on-pump CABG , especially those with low LVEF , is beneficial .

milrinone

milrinone

coronary artery bypass graft ( CABG ) .

as placebo

milrinone

milrinone

Hemodynamic parameters

mean duration of using inotropic agents

development of ventricular arrhythmia

duration of cardiopulmonary bypass

duration of intensive care unit stay

mortality rate

ventricular dysfunction

coronary artery bypass graft

Seventy

left ventricular ejection fraction


Comparable patencies of the radial artery and right internal thoracic artery or saphenous vein beyond 5 years : results from the Radial Artery Patency and Clinical Outcomes trial . OBJECTIVE To investigate the optimum conduit for coronary targets other than the left anterior descending artery , we evaluated long-term patencies and clinical outcomes of the radial artery , right internal thoracic artery , and saphenous vein through the Radial Artery Patency and Clinical Outcomes trial . METHODS As part of a 10-year prospective , randomized , single-center trial , patients undergoing primary coronary surgery were allocated to the radial artery ( n = 198 ) or free right internal thoracic artery ( n = 196 ) if aged less than 70 years ( group 1 ) , or radial artery ( n = 113 ) or saphenous vein ( n = 112 ) if aged at least 70 years ( group 2 ) . All patients received a left internal thoracic artery to the left anterior descending , and the randomized conduit was used to graft the second largest target . Protocol-directed angiography has been performed at randomly assigned intervals , weighted toward the end of the study period . Grafts are defined as failed if there was occlusion , string sign , or greater than 80 % stenosis , independently reported by 3 assessors . Analysis is by intention to treat . RESULTS At mean follow up of 5.5 years , protocol angiography has been performed in groups 1 and 2 in 237 and 113 patients , respectively . There are no significant differences within each group in preoperative comorbidity , age , or urgency . Patencies were similar for either of the 2 conduits in each group ( log rank analysis , P = .06 and P = .54 , respectively ) . The differences in estimated 5-year patencies were 6.6 % ( radial minus right internal thoracic artery ) in group 1 and 2.9 % ( radial minus saphenous vein graft ) in group 2 . CONCLUSION At mean 5-year angiography in largely asymptomatic patients , the selection of arterial or venous conduit for the second graft has not significantly affected patency . This finding offers surgeons , for now , enhanced flexibility in planning revascularization .

radial artery

internal thoracic artery

saphenous vein

Protocol-directed angiography

Patencies

5-year patencies

primary coronary surgery

less than 70

at least 70


Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease ( VTACH ) : a multicentre randomised controlled trial . BACKGROUND In patients with ventricular tachycardia ( VT ) and a history of myocardial infarction , intervention with an implantable cardioverter defibrillator ( ICD ) can prevent sudden cardiac death and thereby reduce total mortality . However , ICD shocks are painful and do not provide complete protection against sudden cardiac death . We assessed the potential benefit of catheter ablation before implantation of a cardioverter defibrillator . METHODS The Ventricular Tachycardia Ablation in Coronary Heart Disease ( VTACH ) study was a prospective , open , randomised controlled trial , undertaken in 16 centres in four European countries . Patients aged 18-80 years were eligible for enrolment if they had stable VT , previous myocardial infarction , and reduced left-ventricular ejection fraction ( LVEF ; < or=50 % ) . 110 patients were randomly allocated in a 1:1 ratio to receive catheter ablation and an ICD ( ablation group , n=54 ) or ICD alone ( control group , n=56 ) . Randomisation was done by computer-generated randomly permuted blocks and stratified by centre and LVEF ( < or=30 % or > 30 % ) . Patients were followed up for at least 1 year . The primary endpoint was the time to first recurrence of VT or ventricular fibrillation ( VF ) . Analysis was by intention to treat ( ITT ) . This study is registered with ClinicalTrials.gov , number NCT00919373 . FINDINGS 107 patients were included in the ITT population ( ablation group , n=52 ; control group , n=55 ) . Two patients ( one in each group ) withdrew consent immediately after randomisation without any follow-up data and one patient ( ablation group ) was excluded because of a protocol violaton . Mean follow-up was 22.5 months ( SD 9.0 ) . Time to recurrence of VT or VF was longer in the ablation group ( median 18.6 months [ lower quartile 2.4 , upper quartile not determinable ] ) than in the control group ( 5.9 months [ IQR 0.8-26.7 ] ) . At 2 years , estimates for survival free from VT or VF were 47 % in the ablation group and 29 % in the control group ( hazard ratio 0.61 ; 95 % CI 0.37-0.99 ; p=0.045 ) . Complications related to the ablation procedure occurred in two patients ; no deaths occurred within 30 days after ablation . 15 device-related complications requiring surgical intervention occurred in 13 patients ( ablation group , four ; control group , nine ) . Nine patients died during the study ( ablation group , five ; control group , four ) . INTERPRETATION Prophylactic VT ablation before defibrillator implantation seemed to prolong time to recurrence of VT in patients with stable VT , previous myocardial infarction , and reduced LVEF . Prophylactic catheter ablation should therefore be considered before implantation of a cardioverter defibrillator in such patients . FUNDING St Jude Medical .

defibrillator

catheter ablation

ICD alone ( control group , n=56 )

ablation group

control

ablation group

control group

ablation group

control group

ablation group

control group

ablation

control

Prophylactic VT ablation

defibrillator implantation

Prophylactic catheter ablation

cardioverter defibrillator

Time to recurrence of VT or VF

survival

VT or VF

no deaths

died

ventricular tachycardia

defibrillator implantation

coronary heart disease ( VTACH )

ventricular tachycardia ( VT )

myocardial infarction

18-80 years

stable VT

previous myocardial infarction

Nine

stable VT

previous myocardial infarction

reduced LVEF


Hunter DBT project : randomized controlled trial of dialectical behaviour therapy in women with borderline personality disorder . OBJECTIVE Deliberate self-harm ( DSH ) , general hospital admission and psychiatric hospital admission are common in women meeting criteria for borderline personality disorder ( BPD ) . Dialectical behaviour therapy ( DBT ) has been reported to be effective in reducing DSH and hospitalization . METHOD A randomized controlled trial of 73 female subjects meeting criteria for BPD was carried out with intention-to-treat analyses and per-protocol analyses . The intervention was DBT and the control condition was treatment as usual plus waiting list for DBT ( TAU+WL ) , with outcomes measured after 6 months . Primary outcomes were differences in proportions and event rates of : any DSH ; general hospital admission for DSH and any psychiatric admission ; and mean difference in length of stay for any hospitalization . Secondary outcomes were disability and quality of life measures . RESULTS Both groups showed a reduction in DSH and hospitalizations , but there were no significant differences in DSH , hospital admissions or length of stay in hospital between groups . Disability ( days spent in bed ) and quality of life ( Physical , Psychological and Environmental domains ) were significantly improved for the DBT group . CONCLUSION DBT produced non-significant reductions in DSH and hospitalization when compared to the TAU+WL control , due in part to the lower than expected rates of hospitalization in the control condition . Nevertheless , DBT showed significant benefits for the secondary outcomes of improved disability and quality of life scores , a clinically useful result that is also in keeping with the theoretical constructs of the benefits of DBT .

dialectical behaviour therapy

Dialectical behaviour therapy ( DBT )

DBT

DBT

DBT

DBT .

general hospital admission for DSH

psychiatric admission

disability and quality of life measures

DSH and hospitalizations

Disability ( days spent in bed )

DSH

disability and quality of life scores


Enhancing caregiver health : findings from the resources for enhancing Alzheimer 's caregiver health II intervention . OBJECTIVES To examine the relationships between changes from baseline to post-Resources for Enhancing Alzheimer 's Caregiver Health ( REACH ) intervention in caregiver ( CG ) self-reported health , burden , and bother . DESIGN Randomized , multisite clinical trial . SETTING CG and care recipient ( CR ) homes in five U.S. cities . PARTICIPANTS Four hundred ninety-five dementia CG and CR dyads ( 169 Hispanic , 160 white , and 166 African American ) receiving intervention and their controls . INTERVENTION CGs were assigned to the REACH intervention or a no-treatment control group . Intervention subjects received individual risk profiles and the REACH intervention through nine in-home and three telephone sessions over 6 months . Control subjects received two brief " check-in " telephone calls during this 6-month period . MEASUREMENTS The primary outcome was change in CG health status from baseline to after the intervention . Secondary outcomes were CG burden and bother after the intervention . RESULTS After the intervention , CGs reported better self-rated health , sleep quality , physical health , and emotional health , which was related to less burden and bother with their caregiving role than for CGs not receiving the intervention . Changes in depression appeared to mediate these relationships . Several racial and ethnic group differences existed in physical and emotional health , as well as in total frustration with caregiving , emotional burden , and CG-rated bother with CR 's activities of daily living and instrumental activities of daily living at baseline and at follow-up , although differences between baseline and posttest did not vary according to race . CONCLUSION A structured , multicomponent skills training intervention that targeted CG self-care behaviors as one of five target areas , improved self-reported health status , and decreased burden and bother in racially and ethnically diverse CGs of people with dementia .

REACH intervention

no-treatment control group

REACH intervention through

in-home

telephone sessions

check-in " telephone calls

change in CG health status

self-rated health

sleep quality

physical health

emotional health

depression

physical

emotional health

total frustration with caregiving

emotional burden

CG-rated bother

self-reported health status

burden

Alzheimer 's

Four hundred ninety-five

dementia CG and CR dyads

dementia


Minimally invasive compared with traditional transgluteal approach for total hip arthroplasty : a comparative gait analysis . BACKGROUND Minimally invasive total hip arthroplasty is purported to allow an improved and faster rehabilitation in the immediate postoperative period because of reduced soft-tissue damage compared with total hip arthroplasty performed with use of a standard approach . In the present study , a minimally invasive approach was compared with a traditional standard approach in terms of the effect on gait kinematics as demonstrated with gait analysis and electromyography . METHODS Twenty randomized patients who underwent a primary total hip replacement with use of a minimally invasive modified Watson-Jones approach ( minimally invasive group ) were compared with a group of twenty patients who underwent a total hip arthroplasty with use of a standard transgluteal Hardinge approach ( standard group ) . All patients received the same cementless implant , inserted with use of standard instruments , and all operations were performed by a single , experienced surgeon . The patients were evaluated with use of three-dimensional gait analysis and dynamic electromyograms at three time points : preoperatively , ten days postoperatively , and twelve weeks postoperatively . Temporospatial and joint-kinematic parameters were evaluated . RESULTS There were no significant differences between the two groups with regard to the temporospatial variables of velocity , cadence , step length , and stride length at any tested time point . With regard to the range of motion of the operatively treated hip , the minimally invasive group had a smaller decrease at the ten-day time point in comparison with the standard group . However , this finding was not significant . The reduction in the range of motion was mainly caused by reduced hip extension . A compensatory increase in the pelvic tilt was observed in both groups . One patient in the standard group showed a positive Trendelenburg gait ten days postoperatively ; it had disappeared completely at the twelve-week time point . CONCLUSIONS With regard to gait kinematics in the early postoperative period ( three months ) , the present study showed no significant benefit for patients who underwent a total hip arthroplasty through a minimally invasive Watson-Jones approach in comparison with those who were managed with a standard transgluteal approach .

cementless implant

gait

range of motion

range of motion

pelvic tilt

Trendelenburg gait

total hip arthroplasty

Twenty

primary total hip replacement

twenty

total hip arthroplasty

standard transgluteal approach


Oral 6-mercaptopurine versus oral 6-thioguanine and veno-occlusive disease in children with standard-risk acute lymphoblastic leukemia : report of the Children 's Oncology Group CCG-1952 clinical trial . The Children 's Cancer Group 1952 ( CCG-1952 ) clinical trial studied the substitution of oral 6-thioguanine ( TG ) for 6-mercaptopurine ( MP ) and triple intrathecal therapy ( ITT ) for intrathecal methotrexate ( IT-MTX ) in the treatment of standard-risk acute lymphoblastic leukemia . After remission induction , 2027 patients were randomized to receive MP ( n = 1010 ) or TG ( n = 1017 ) and IT-MTX ( n = 1018 ) or ITT ( n = 1009 ) . The results of the thiopurine comparison are as follows . The estimated 7-year event-free survival ( EFS ) for subjects randomized to TG was 84.1 % ( +/- 1.8 % ) and to MP was 79.0 % ( +/- 2.1 % ; P = .004 log rank ) , although overall survival was 91.9 % ( +/- 1.4 % ) and 91.2 % ( +/- 1.5 % ) , respectively ( P = .6 log rank ) . The TG starting dose was reduced from 60 to 50 mg/m ( 2 ) per day after recognition of hepatic veno-occlusive disease ( VOD ) . A total of 257 patients on TG ( 25 % ) developed VOD or disproportionate thrombocytopenia and switched to MP . Once portal hypertension occurred , all subjects on TG were changed to MP . The benefit of randomization to TG over MP , as measured by EFS , was evident primarily in boys who began TG at 60 mg/m ( 2 ) ( relative hazard rate [ RHR ] 0.65 , P = .002 ) . The toxicities of TG preclude its protracted use as given in this study . This study is registered at http : //clinicaltrials.gov as NCT00002744 .

Oral 6-mercaptopurine

oral 6-thioguanine

MP

TG

IT-MTX

ITT

event-free survival ( EFS )

overall survival

hepatic veno-occlusive disease ( VOD )

VOD

disproportionate thrombocytopenia

portal hypertension

children

Children 's


[ Value of combining 64 multi-slice spiral computer tomography and serum amyloid A protein in surgical decision-making in rectal cancer ] . OBJECTIVE To determine the accuracy and clinical value of combining 64 multi-slice spiral computer tomography ( MSCT ) and serum amyloid A protein ( SAA ) in the preoperative staging of rectal cancer . METHODS Prospectively enrolled patients with rectal cancer from October 2007 to October 2008 . The patients were randomly assigned into two groups : MSCT and SAA combined group : both MSCT and SAA combinative assessment were performed for preoperative evaluation ; MSCT group : only MSCT was performed preoperatively for tumor staging . The accuracy of the preoperative T , N , M , and TNM staging and the concordance rate of predictive operative strategy were compared between the two groups . RESULTS Total of 225 cases with rectal cancer were enrolled in this study . There were 110 cases in MSCT and SAA combined group and 115 cases in MSCT group . The baseline characteristics was comparable between the two groups . For MSCT and SAA combined group , the accuracies of preoperative staging of T , N , M and TNM was 87.3 % , 85.2 % , 100 % and 86.4 % , respectively ; and for MSCT group , the corresponding rates was 85.2 % , 67.0 % , 100 % and 66.1 % , respectively . Statistical differences was found in the accuracy of preoperative N and TNM staging between the two groups ( P = 0.009 and 0.001 , respectively ) . In addition , there was statistical difference in the accuracy of prediction to operative procedures between the two groups ( 94.7 % vs. 81.7 % , P = 0.003 ) . CONCLUSION Combinative assessment of MSCT and SAA could improve the accuracy of preoperative staging , and thus provide higher predictive coincidence rate of operative procedures .

64 multi-slice spiral

computer tomography

serum amyloid A protein

serum amyloid A protein ( SAA )

MSCT

SAA

MSCT

SAA

MSCT group

MSCT

SAA

MSCT

MSCT

SAA

MSCT

SAA

rectal cancer

rectal cancer

rectal cancer

rectal cancer