Randomized controlled study of chemoimmunotherapy with bestatin of acute nonlymphocytic leukemia in adults . A new immunomodulating agent , bestatin ( INN : Ubenimex has low toxicity even after long-term oral administration and has significant modifications in immunological response . A cooperative randomized controlled study of bestatin immunotherapy in combination with remission maintenance chemotherapy for adult acute nonlymphocytic leukemia ( ANLL ) was performed . After induction of complete remission , patients were randomized to the bestatin group ( 30 mg/bw per os ( po ) daily ) and the control group . The 101 eligible cases ( bestatin : 48 , control : 53 ) were analyzed ; the bestatin group achieved longer remission than the control group and a statistically significant longer survival . Though this prolongation of remission was not significant in the bestatin group compared to the control group in the 15-49 yr age group , in the 50-65 yr age group it was significantly longer . Bestatin is shown to be a clinically useful drug for immunotherapy of adult ANLL , since it has prolonged survival and remission especially in elderly patients , with few side-effects .

bestatin

bestatin

bestatin

bestatin

bestatin

bestatin

bestatin

Bestatin

remission

survival .

prolongation of remission

survival

remission

side-effects .

acute nonlymphocytic leukemia

adults

adult

acute nonlymphocytic leukemia ( ANLL )


Goal attainment scaling as an outcome measure in randomized controlled trials of psychosocial interventions in autism . Goal attainment scaling ( GAS ) holds promise as an idiographic approach for measuring outcomes of psychosocial interventions in community settings . GAS has been criticized for untested assumptions of scaling level ( i.e. , interval or ordinal ) , inter-individual equivalence and comparability , and reliability of coding across different behavioral observation methods . We tested assumptions of equality between GAS descriptions for outcome measurement in a randomized trial ( i.e. , measurability , equidistance , level of difficulty , comparability of behavior samples collected from teachers vs. researchers and live vs. videotape ) . Results suggest GAS descriptions can be evaluated for equivalency , that teacher collected behavior samples are representative , and that varied sources of behavior samples can be reliably coded . GAS is a promising measurement approach . Recommendations are provided to ensure methodological quality .

psychosocial interventions

psychosocial interventions

Goal attainment scaling

Goal attainment scaling ( GAS )

autism .


Intermediate-term mortality and cardiac transplantation in infants with single-ventricle lesions : risk factors and their interaction with shunt type . OBJECTIVE The study objective was to identify factors associated with death and cardiac transplantation in infants undergoing the Norwood procedure and to determine differences in associations that might favor the modified Blalock-Taussig shunt or a right ventricle-to-pulmonary artery shunt . METHODS We used competing risks methodology to analyze death without transplantation , cardiac transplantation , and survival without transplantation . Parametric time-to-event modeling and bootstrapping were used to identify independent predictors . RESULTS Data from 549 subjects ( follow-up , 2.7 ± 0.9 years ) were analyzed . Mortality risk was characterized by early and constant phases ; transplant was characterized by only a constant phase . Early phase factors associated with death included lower socioeconomic status ( P = .01 ) , obstructed pulmonary venous return ( P < .001 ) , smaller ascending aorta ( P = .02 ) , and anatomic subtype . Constant phase factors associated with death included genetic syndrome ( P < .001 ) and lower gestational age ( P < .001 ) . The right ventricle-to-pulmonary artery shunt demonstrated better survival in the 51 % of subjects who were full term with aortic atresia ( P < .001 ) . The modified Blalock-Taussig shunt was better among the 4 % of subjects who were preterm with a patent aortic valve ( P = .003 ) . Lower pre-Norwood right ventricular fractional area change , pre-Norwood surgery , and anatomy other than hypoplastic left heart syndrome were independently associated with transplantation ( all P < .03 ) , but shunt type was not ( P = .43 ) . CONCLUSIONS Independent risk factors for intermediate-term mortality include lower socioeconomic status , anatomy , genetic syndrome , and lower gestational age . Term infants with aortic atresia benefited from a right ventricle-to-pulmonary artery shunt , and preterm infants with a patent aortic valve benefited from a modified Blalock-Taussig shunt . Right ventricular function and anatomy , but not shunt type , were associated with transplantation .

cardiac transplantation

cardiac transplantation

Mortality risk

with death

with death

survival

infants

single-ventricle lesions

infants

undergoing the Norwood procedure


Preschoolers acquire general knowledge by sharing in pretense . Children acquire general knowledge about many kinds of things , but there are few known means by which this knowledge is acquired . In this article , it is proposed that children acquire generic knowledge by sharing in pretend play . In Experiment 1 , twenty-two 3- to 4-year-olds watched pretense in which a puppet represented a " nerp " ( an unfamiliar kind of animal ) . For instance , in one scenario , the nerp ate and disliked a carrot . When subsequently asked generic questions about real nerps , children 's responses suggested that they had learned general facts ( e.g. , nerps dislike carrots ) . In Experiment 2 , thirty-two 4- to 5-year-olds learned from scenarios lacking pretend speech or sound effects . The findings reveal a long overlooked means by which children can acquire generic knowledge .

pretense

pretend play .

pretense

responses

Preschoolers

twenty-two

3- to 4-year-olds

thirty-two

4- to 5-year-olds


Training referential communicative skills to individuals with autism spectrum disorder : a pilot study . The present study reports the effects of referential communication training in individuals formally diagnosed with autism spectrum disorder ( ASD ) . Participants were 20 children with ASD ( M age = 14.3 yr. , SD = 4.2 ; 6 girls , 14 boys ) in the role of speakers and 20 control children , who acted as listeners . They were all enrolled in mainstream compulsory education . Inclusion/exclusion criteria were defined according to the clinical diagnosis of ASD , the presence or absence of additional or associated disability , previous training in referential communication , and any drug treatment . Speakers were randomly assigned to one of two groups ( trained vs untrained ) . Linguistic age , cognitive level and autistic symptoms were analyzed , respectively , with the Peabody Picture Vocabulary Test ( PPVT ) , the Wechsler Intelligence Scale ( WISC-R or WAIS-III ) , and the Autistic Behavior Checklist ( ABC ) . Communicative abilities were analyzed through two indexes related to message complexity and self-regulation . The trained group was trained in referential communication tasks ( task analysis , role taking , and task evaluation ) , while the untrained group took part in a communicative game but without any specific communicative training . The results showed that the complexity of emitted messages had improved statistically significantly in the trained group as an effect of training . Ecological referential communication is shown to be an appropriate paradigm for studying the communicative process and its products and could be used to develop and implement a training program focused on those skills in which individuals with ASD are most deficient .

referential communicative skills

referential communication training

task evaluation )

communicative game

referential communication

complexity of emitted messages

children

ASD

M age = 14.3 yr.

SD = 4.2

children

individuals with ASD


Group cognitive behavior therapy for children with high-functioning autism spectrum disorders and anxiety : a randomized trial . BACKGROUND Children with high-functioning autism spectrum disorders ( ASD ) are at high risk for developing significant anxiety . Anxiety can adversely impact functioning across school , home and community environments . Cognitive behavioral therapies ( CBT ) are frequently used with success for children with anxiety symptoms . Modified CBT interventions for anxiety in children with ASD have also yielded promising results . METHODS Fifty children with high-functioning ASD and anxiety were randomizedto group CBT or treatment-as-usual ( TAU ) for 12 weeks . Independent clinical evaluators , blind to condition , completed structured interviews ( Anxiety Disorders Interview Schedule – Parent Version ; ADIS-P ) pre- and post-intervention condition . RESULTS Forty-seven children completed either the CBT or TAU condition . Results indicated markedly better outcomes for the CBT group . Significant differences by group were noted in Clinician Severity Ratings , diagnostic status , and clinician ratings of global improvement . In the intent-to-treat sample , 10 of 20 children ( 50 % ) in the CBT group had a clinically meaningful positive treatment response , compared to 2 of 23 children ( 8.7 % ) in the TAU group . CONCLUSIONS Initial results from this randomized , designed treatment study suggest that agroup CBT intervention specifically developed for children with ASD may be effective in decreasing anxiety . Limitations of this study include small sample size , lack of an attention control group , and use of outcome measures normed with typically developing children

Group cognitive behavior therapy

Cognitive behavioral therapies ( CBT )

CBT

CBT

treatment-as-usual ( TAU )

CBT

TAU

CBT

CBT

CBT

anxiety symptoms .

children

Fifty

children

high-functioning ASD and anxiety

Forty-seven

children


Spotty calcification as a marker of accelerated progression of coronary atherosclerosis : insights from serial intravascular ultrasound . OBJECTIVES The purpose of this study was to determine atheroma progression in patients with spotty calcification . BACKGROUND Although extensively calcified atherosclerotic lesions have been proposed to be clinically quiescent , the presence of spotty calcification within plaque has been reported to be associated with an increased incidence of ischemic cardiovascular events . The relationship between spotty calcification and disease progression has not been investigated . METHODS A total of 1,347 stable patients with angiographic coronary artery disease underwent serial evaluation of atheroma burden with intravascular ultrasound imaging . Patients with spotty calcification were identified based on the presence of lesions ( 1 to 4 mm in length ) containing an arc of calcification of < 90° . Clinical characteristics and disease progression were compared between patients with spotty calcification ( n = 922 ) and those with no calcification ( n = 425 ) . RESULTS Patients with spotty calcification were older ( age 56 years vs. 54 years ; p = 0.001 ) , more likely to be male ( 68 % vs. 54 % ; p = 0.01 ) , and have a history of diabetes mellitus ( 30 % vs. 24 % ; p = 0.01 ) and myocardial infarction ( 28 % vs. 20 % ; p = 0.004 ) , and have lower on-treatment high-density lipoprotein cholesterol levels ( 48 ± 16 mg/dl vs. 51 ± 17 mg/dl ; p = 0.001 ) . Patients with spotty calcification demonstrated a greater percent atheroma volume ( PAV ) ( 36.0 ± 7.6 % vs. 29.0 ± 8.5 % ; p < 0.001 ) and total atheroma volume ( 174.6 ± 71.9 mm ( 3 ) vs. 133.9 ± 64.9 mm ( 3 ) ; p < 0.001 ) . On serial evaluation , spotty calcification was associated with greater progression of PAV ( +0.43 ± 0.07 % vs. +0.02 ± 0.11 % ; p = 0.002 ) . Although intensive low-density lipoprotein cholesterol and blood pressure lowering therapy slowed disease progression , these efficacies were attenuated in patients with spotty calcification . CONCLUSIONS The presence of spotty calcification is associated with more extensive and diffuse coronary atherosclerosis and accelerated disease progression despite use of medical therapies .

atheroma progression

disease progression

atheroma burden

greater progression

coronary atherosclerosis

patients with spotty calcification .


Effects of guided imagery with relaxation training on anxiety and quality of life among patients with inflammatory bowel disease . BACKGROUND Inflammatory Bowel Disease ( IBD ) impacts quality of life ( QoL ) . Psychological factors influence the course of the disease and should be targeted for intervention . METHODS Our study was a prospective , randomised control trial . Fifty-six outpatients were randomly chosen and allocated to a treatment group or a waiting-list control group . Treatment group patients attended three relaxation-training sessions and received an audio disc for home practice . Evaluations performed pre and post-treatment : state anxiety was assessed with the State-Trait Anxiety Inventory , QoL with the IBD Questionnaire . The Visual Analogue Scale assessed pain , depression , stress and mood . Patients completed a symptom monitoring diary . The control group 's symptoms were monitored without study-related treatment . RESULTS Thirty-nine subjects completed the study and were included in the data analysis . Following the relaxation-training intervention , the treatment group 's ( n = 18 ) measured results showed a statistically significant improvement as compared to the control group ( n = 21 ) ( time by treatment interaction ) : anxiety levels decreased ( p < 0.01 ) , QoL and mood improved ( p < 0.05 ) , while levels of pain and stress decreased ( p < 0.01 ) . CONCLUSIONS Findings indicate IBD patients may benefit from relaxation training in their holistic care . New studies as well as further investigation of the subject are warranted .

relaxation training

relaxation-training sessions

relaxation-training

anxiety

quality of life

quality of life ( QoL ) .

state anxiety

Visual Analogue Scale

pain

depression

stress

mood

Fifty-six outpatients


Parent-implemented enhanced milieu teaching with preschool children who have intellectual disabilities . PURPOSE The purpose of this study was to compare the effects of enhanced milieu teaching ( EMT ) implemented by parents and therapists versus therapists only on the language skills of preschool children with intellectual disabilities ( IDs ) , including children with Down syndrome and children with autism spectrum disorders . METHOD Seventy-seven children were randomly assigned to 2 treatments ( parent + therapist EMT or therapist-only EMT ) and received 36 intervention sessions . Children were assessed before , immediately after , 6 months after , and 12 months after intervention . Separate linear regressions were conducted for each standardized and observational measure at each time point . RESULTS Parents in the parent + therapist group demonstrated greater use of EMT strategies at home than untrained parents in the therapist-only group , and these effects maintained over time . Effect sizes for observational measures ranged from d = 0.10 to d = 1.32 favoring the parent + therapist group , with the largest effect sizes found 12 months after intervention . CONCLUSION Findings from this study indicate generally that there are benefits to training parents to implement naturalistic language intervention strategies with preschool children who have ID and significant language impairments .

enhanced milieu teaching

enhanced milieu teaching ( EMT )

parent + therapist EMT

therapist-only EMT

EMT

EMT strategies

observational measures

preschool children

who have intellectual disabilities .

Seventy-seven

children


RESPECT-PTSD : re-engineering systems for the primary care treatment of PTSD , a randomized controlled trial . BACKGROUND Although collaborative care is effective for treating depression and other mental disorders in primary care , there have been no randomized trials of collaborative care specifically for patients with Posttraumatic stress disorder ( PTSD ) . OBJECTIVE To compare a collaborative approach , the Three Component Model ( 3CM ) , with usual care for treating PTSD in primary care . DESIGN The study was a two-arm , parallel randomized clinical trial . PTSD patients were recruited from five primary care clinics at four Veterans Affairs healthcare facilities and randomized to receive usual care or usual care plus 3CM . Blinded assessors collected data at baseline and 3-month and 6-month follow-up . PARTICIPANTS Participants were 195 Veterans . Their average age was 45 years , 91 % were male , 58 % were white , 40 % served in Iraq or Afghanistan , and 42 % served in Vietnam . INTERVENTION All participants received usual care . Participants assigned to 3CM also received telephone care management . Care managers received supervision from a psychiatrist . MAIN MEASURES PTSD symptom severity was the primary outcome . Depression , functioning , perceived quality of care , utilization , and costs were secondary outcomes . KEY RESULTS There were no differences between 3CM and usual care in symptoms or functioning . Participants assigned to 3CM were more likely to have a mental health visit , fill an antidepressant prescription , and have adequate antidepressant refills . 3CM participants also had more mental health visits and higher outpatient pharmacy costs . CONCLUSIONS Results suggest the need for careful examination of the way that collaborative care models are implemented for treating PTSD , and for additional supports to encourage primary care providers to manage PTSD .

Three Component Model ( 3CM )

usual care

usual care

usual care

usual care

telephone care management

PTSD symptom severity

Depression

functioning

perceived quality of care

utilization

costs

symptoms

functioning .

mental health visit

fill an antidepressant prescription

adequate antidepressant refills .

mental health visits

outpatient pharmacy costs

PTSD

PTSD

Veterans

average age was 45 years

91 % were

male


Teaching emotion recognition skills to young children with autism : a randomised controlled trial of an emotion training programme . BACKGROUND Children with autism have difficulties in emotion recognition and a number of interventions have been designed to target these problems . However , few emotion training interventions have been trialled with young children with autism and co-morbid ID . This study aimed to evaluate the efficacy of an emotion training programme for a group of young children with autism with a range of intellectual ability . METHODS Participants were 55 children with autistic disorder , aged 4-7 years ( FSIQ 42-107 ) . Children were randomly assigned to an intervention ( n = 28 ) or control group ( n = 27 ) . Participants in the intervention group watched a DVD designed to teach emotion recognition skills to children with autism ( the Transporters ) , whereas the control group watched a DVD of Thomas the Tank Engine . Participants were assessed on their ability to complete basic emotion recognition tasks , mindreading and theory of mind ( TOM ) tasks before and after the 4-week intervention period , and at 3-month follow-up . RESULTS Analyses controlled for the effect of chronological age , verbal intelligence , gender and DVD viewing time on outcomes . Children in the intervention group showed improved performance in the recognition of anger compared with the control group , with few improvements maintained at 3-month follow-up . There was no generalisation of skills to TOM or social skills . CONCLUSIONS The Transporters programme showed limited efficacy in teaching basic emotion recognition skills to young children with autism with a lower range of cognitive ability . Improvements were limited to the recognition of expressions of anger , with poor maintenance of these skills at follow-up . These findings provide limited support for the efficacy of the Transporters programme for young children with autism of a lower cognitive range .

emotion recognition

emotion training programme

emotion training

emotion training programme

emotion recognition skills

the Transporters

control

Thomas the Tank Engine .

The Transporters

Transporters

efficacy

basic emotion recognition tasks

recognition of anger

TOM

social skills .

efficacy

young children with autism :

young children

children with autistic disorder

aged 4-7 years

young children with autism

young children with autism


Effect of rosuvastatin monotherapy or in combination with fenofibrate or ω-3 fatty acids on lipoprotein subfraction profile in patients with mixed dyslipidaemia and metabolic syndrome . BACKGROUND Raised triglycerides ( TG ) , decreased high-density lipoprotein cholesterol ( HDL-C ) levels and a predominance of small dense low density lipoproteins ( sdLDL ) are characteristics of the metabolic syndrome ( MetS ) . OBJECTIVE To compare the effect of high-dose rosuvastatin monotherapy with moderate dosing combined with fenofibrate or ω-3 fatty acids on the lipoprotein subfraction profile in patients with mixed dyslipidaemia and MetS . METHODS We previously randomised patients with low-density lipoprotein cholesterol ( LDL-C ) > 160 and TG > 200 mg/dl to rosuvastatin monotherapy 40 mg/day ( R group , n = 30 ) or rosuvastatin 10 mg/day combined with fenofibrate 200 mg/day ( RF group , n = 30 ) or ω-3 fatty acids 2 g/day ( Rω group , n = 30 ) . In the present study , only patients with MetS were included ( 24 , 23 and 24 in the R , RF and Rω groups respectively ) . At baseline and after 12 weeks of treatment , the lipoprotein subfraction profile was determined by polyacrylamide 3 % gel electrophoresis . RESULTS The mean LDL size was significantly increased in all groups . This change was more prominent with RF than with other treatments in parallel with its greater hypotriglyceridemic capacity ( p < 0.05 compared with R and Rω ) . A decrease in insulin resistance by RF was also noted . Only RF significantly raised HDL-C levels ( by 7.7 % , p < 0.05 ) by increasing the cholesterol of small HDL particles . The cholesterol of larger HDL subclasses was significantly increased by R and Rω . CONCLUSIONS All regimens increased mean LDL size ; RF was the most effective . A differential effect of treatments was noted on the HDL subfraction profile .

rosuvastatin

fenofibrate

ω-3 fatty acids

rosuvastatin

fenofibrate

ω-3 fatty acids

rosuvastatin

rosuvastatin

fenofibrate

ω-3 fatty

lipoprotein subfraction profile

lipoprotein subfraction profile

lipoprotein subfraction

mean

insulin resistance

cholesterol of larger HDL

patients with MetS


A randomized double-blind placebo-controlled cross-over trial of the impact on quality of life of continuing dexamethasone beyond 24 h following adjuvant chemotherapy for breast cancer . Uncertainty remains about the optimal anti-emetic regimen for control of delayed nausea and vomiting after adjuvant chemotherapy for breast cancer . Many patients receive dexamethasone but complain of insomnia , anxiety/agitation , and indigestion . The aim was to determine if patients receiving chemotherapy for breast cancer prefer treatment with dexamethasone or placebo for prophylaxis against delayed nausea and vomiting , and to compare quality of life ( QOL ) between the two treatments . In this randomized , double-blind , cross-over trial , we compared oral dexamethasone ( 4 mg twice daily for 2 days ) versus placebo for chemotherapy-naïve patients with breast cancer . All patients received intravenous granisetron and dexamethasone pre-chemotherapy and oral granisetron on day 2 . Primary endpoints were : ( i ) patient preference ; ( ii ) difference between cycles in change of QOL from days 1 to 8 . Median age of the 94 women was 51 years ( range 27-76 ) : 79 received fluorouracil/epirubicin/cyclophosphamide and 15 received doxorubicin/cyclophosphamide . Thirteen withdrew pre-cycle 2 with no differences between arms . Of 80 patients stating a preference , 31 preferred placebo ( 39 % , 95 % CI : 28-50 % ) and 37 ( 46 % , 95 % CI : 35-58 % ) preferred dexamethasone ; 12 had no preference . There were no differences in intensity of vomiting , nausea , or time to onset of vomiting . There was greater decrease in global QOL ( p = 0.06 ) when patients received dexamethasone . No other symptom/QOL domains differed significantly . In conclusion , no significant difference was found in patient preference , QOL , or symptoms regardless of whether dexamethasone or placebo was used after adjuvant chemotherapy .

placebo-controlled

dexamethasone

chemotherapy

chemotherapy

dexamethasone

chemotherapy

dexamethasone

placebo

dexamethasone

placebo

granisetron

dexamethasone pre-chemotherapy

granisetron

doxorubicin/cyclophosphamide

placebo

dexamethasone

dexamethasone

dexamethasone

quality of life

quality of life ( QOL )

patient preference

symptom/QOL

patient preference

QOL

breast cancer

breast cancer

women

51 years ( range 27-76 )


Adherence to lifestyle recommendations by patients with depression . INTRODUCTION There is an increasing amount of evidence showing that physical activity and sun exposure are effective coadjuvant treatments for patients with mild to moderate depression . However , there is a lack of information regarding patient 's adherence to these recommendations in daily clinical practice . METHODS We conducted a study including 15 depressive patients who had been under antidepressant treatment for at least one month . They wore a wrist-watch-like actimetry sensor to measure physical activity and sun exposure 24 hours a day . After one week of baseline assessment , patients were randomised into one of the two arms of the study . Patients in the experimental group received a brief note in which they were explicitly asked to increase both their physical activity level and time of sun exposure , while control group patients did not receive these explicit recommendations . RESULTS One week after recommendations were delivered , only patients in the experimental group had increased time of sun exposure and physical activity ( 25.8 % and 14.3 % , respectively ) . CONCLUSIONS Depressive patients are able to follow prescribed lifestyle recommendations in the short-term .

lifestyle

physical activity

physical activity

sun exposure

control

Adherence

adherence

physical activity

sun exposure

physical activity level

time of sun exposure

time of sun exposure

physical activity

patients with depression .

Depressive patients


Role of posterior tibial nerve stimulation in the treatment of refractory monosymptomatic nocturnal enuresis : a pilot study . PURPOSE We evaluated the early clinical and urodynamic results of posterior tibial nerve stimulation in patients with refractory monosymptomatic nocturnal enuresis . MATERIALS AND METHODS We randomly assigned 28 patients with refractory monosymptomatic nocturnal enuresis to 2 equal groups . Group 1 received a weekly session of posterior tibial nerve stimulation for 12 weeks and group 2 was the placebo group . Evaluation was performed in each group at baseline and after posterior tibial nerve stimulation to compare clinical and urodynamic findings . Another clinical assessment was done 3 months after the first followup . RESULTS The 2 groups were comparable in baseline clinical and urodynamic data . Overall , 13 patients ( 46.4 % ) had detrusor overactivity and 14 ( 50 % ) had decreased bladder capacity . After treatment 11 group 1 patients ( 78.6 % ) had a partial or full response to posterior tibial nerve stimulation but only 2 ( 14.3 % ) in group 2 had a partial response ( p = 0.002 ) . Also , the average number of wet nights in group 1 was significantly lower than at baseline ( p = 0.002 ) . All urodynamic parameters significantly improved in group 1 . In contrast , the number of wet nights and urodynamic parameters did not change significantly in group 2 . At 3-month followup the number of patients with a partial or full response in group 1 had decreased from 11 ( 78.6 % ) to 6 ( 42.9 % ) . No change was evident in group 2 . CONCLUSIONS Posterior tibial nerve stimulation can be a viable treatment option in some patients with refractory monosymptomatic nocturnal enuresis . However , deterioration in some responders with time suggests the need for maintenance protocols .

posterior tibial nerve stimulation

posterior tibial nerve stimulation

posterior tibial nerve stimulation

placebo

Posterior tibial nerve stimulation

detrusor overactivity

bladder capacity .

response

response

number of wet nights

urodynamic parameters

wet nights

urodynamic parameters

response


Custom-fit minimally invasive total knee arthroplasty : effect on blood loss and early clinical outcomes . PURPOSE Recently , new custom-fit pin guides in total knee arthroplasty ( TKA ) have been introduced . Use of these guides may reduce operating time . Use of the guides combined with the absence of intramedullary alignment jigs may lead to reduced blood loss and improved early outcomes . Our aim was to evaluate blood loss and early clinical outcomes in patients undergoing minimally invasive TKA using custom-fit magnetic resonance imaging ( MRI ) -based pin guides . METHODS A prospective study in 80 patients was carried out . Patients were divided randomly into 2 equal groups . In one group , intramedullary alignment jigs were used . In the second group , custom-fit MRI-based pin guides were used . All patients received the same cemented posterior-stabilized implant through a mini-midvastus approach . The volume in the drain bottles was recorded after 48 h. Hb loss was estimated by subtracting the postoperative from the preoperative Hb level . Transfusion requirements and surgical time were recorded . Outcome measures were Knee Society Scores ( KSS ) , knee flexion , knee swelling and pain . RESULTS There was lower mean drainage of blood in the custom-fit group ( 391 ml vs. 603 ml ; p < 0.0001 ) . There was no difference in estimated loss of Hb ( 3.6 g/dl vs. 4.1 g/dl ; n.s . ) and in transfusion requirements ( 7.5 % vs. 10 % ; n.s. ) . Surgical time was reduced in the custom-fit group ( 12 min less ; p = 0.001 ) . KSS measured at week 2 , 6 and 12 showed no significant difference between groups . Knee flexion measured on days 7 , 10 and at week 6 , 12 and knee swelling and pain measured on days 1 , 3 , 10 and at week 6 , 12 showed no significant difference between groups . CONCLUSIONS Using custom-fit pin guides reduces blood drainage , but not the estimated Hb loss in minimally invasive TKA and does not affect transfusion rate . Surgical time is reduced . There is no effect on the early clinical outcomes . LEVEL OF EVIDENCE Therapeutic study , Level I .

total knee arthroplasty :

total knee arthroplasty ( TKA )

minimally invasive TKA

intramedullary alignment jigs

custom-fit MRI-based pin guides

cemented posterior-stabilized implant

custom-fit

custom-fit

custom-fit pin guides

blood loss

early clinical outcomes

blood loss

early outcomes .

blood loss

early clinical outcomes

Hb loss

Transfusion requirements

surgical time

drainage of blood

loss of Hb

Surgical time

KSS

Knee flexion

knee swelling

pain

blood drainage

Hb loss

transfusion rate

Surgical time

early clinical outcomes .

80 patients


Influence of lime juice on the severity of sickle cell anemia . BACKGROUND AND OBJECTIVES The pain in sickle cell anemia ( SCA ) is often triggered by dehydration , acidosis , and fever that are usually due to malaria . Intake of lime juice was recently demonstrated to facilitate clearance of the malaria parasite . It was therefore sought to determine whether regular intake of lime juice will ameliorate crisis , especially recurrent bone pain . DESIGN In this preliminary , open-labeled , randomized study , the effects of lime juice on the clinical and some laboratory characteristics of children with SCA were tested . RESULTS Among the 113 children with SCA studied in two hospitals , the 58 receiving lime treatment had lower rates of significant painful episodes than the 55 without lime ( 37 versus 83 crises in 6 months , and 0.64±0.11 versus 1.51±0.34 average rates per child , p < 0.001 ) . Also , fewer subjects than the controls had significant painful episodes ( 50.0 % versus 92.7 % ) ; febrile illness ( 46.6 % versus 87.3 % ) and admission rate ( 3.4 % versus 34.5 % ) ( p < 0.001 ) . The mean hematocrit of the subjects ( 26.23±2.03 % ) at the end of the study was also higher , p < 0.001 . However , transfusion rate , presence of hepatomegaly , splenomegaly , and jaundice was similar . Treatment with lime did not cause any significant side-effect . CONCLUSIONS Regular intake of lime juice may be of great therapeutic and nutritional relevance in children with SCA .

lime juice

lime juice

lime juice

lime juice

without lime

lime juice

recurrent bone pain .

significant painful episodes

sickle cell anemia .

children

SCA

children

SCA

children

SCA


The effect of cognitive-behavioral therapy versus treatment as usual for anxiety in children with autism spectrum disorders : a randomized , controlled trial . OBJECTIVE To examine the efficacy of a modular cognitive-behavioral therapy ( CBT ) protocol relative to treatment as usual ( TAU ) among children with high-functioning autism spectrum disorders ( ASD ) and clinically significant anxiety . METHOD A total of 45 children ( 7-11 years of age ) with high-functioning ASD and clinically significant anxiety were randomized to receive 16 sessions of weekly CBT or TAU for an equivalent duration . After screening , assessments were conducted at baseline , post-treatment , and 3-month follow-up . Raters were blind to treatment condition . RESULTS Youth receiving CBT showed substantial improvement relative to TAU on primary anxiety outcomes . Of 24 children randomized to the CBT arm , 18 ( 75 % ) were treatment responders , versus only 3 of 21 children ( 14 % ) in the TAU arm . Gains were generally maintained at 3-month follow-up for CBT responders . CONCLUSIONS Relative to usual care , CBT adapted for anxious youth with high-functioning ASD demonstrates large effects in reducing anxiety symptoms . This study contributes to the growing literature supporting adapted CBT approaches for treating anxiety in youth with ASD .

cognitive-behavioral therapy

treatment as usual

cognitive-behavioral therapy ( CBT )

treatment as usual ( TAU )

CBT

TAU

CBT

TAU

CBT

TAU

CBT

CBT

CBT

efficacy

primary anxiety outcomes .

anxiety symptoms .

children

autism spectrum disorders

children

children ( 7-11 years of age )


Plasma AGE-peptides and C-peptide in early-stage diabetic nephropathy patients on thiamine and pyridoxine therapy . AIM The aim of the study was to evaluate circulatory AGE-peptide levels in diabetic nephropathy and to observe the effects of thiamine ( vitamin B1 ) and pyridoxine ( vitamin B6 ) therapy . METHODS Type 2 diabetic patients ( N.=57 ) were divided into two groups as " with nephropathy " ( N.=27 ) and " without nephropathy " ( N.=30 ) . Diabetic nephropathy patients were treated with either B6 ( N.=12 ) ( 250 mg/day ) or B1+B6 ( N.=15 ) ( 250 mg/day , each ) for five months . At the beginning and the end of the experimentation period , glucose , HbA1c , triglyceride , cholesterol , insulin , C-peptide , thiamine pyrophosphate , pyridoxal phosphate and AGE- peptides were measured . RESULTS AGE-peptides were higher in the diabetic group with nephropathy than without nephropathy ( P=0.005 ) . Within five months AGE-peptides increased in the diabetic group without nephropathy ( P=0.042 ) but not in the group with nephropathy treated either with B1+B6 or B6 . In B6 treated group a substantial decrease was observed in HbA1c ( P=0.033 ) . B1+B6 or B6 treatment both caused an increase in C-peptide ( P=0.006 , P=0.004 ) . CONCLUSION Among the parameters measured , plasma AGE-peptides was the only parameter found to be higher in type 2 diabetes mellitus patients " with nephropathy " than " without nephropathy " . However , patients with nephropathy treated with B1+B6 or B6 did not display any further increase in AGE-peptides within five months . Both of the treatments caused an increase in C-peptide .

thiamine ( vitamin B1 )

pyridoxine ( vitamin B6 )

B6 .

Plasma AGE-peptides and C-peptide

circulatory AGE-peptide levels

AGE-peptides

AGE-peptides

C-peptide

plasma AGE-peptides

AGE-peptides

C-peptide .

Type 2 diabetic patients

Diabetic nephropathy patients

type 2 diabetes mellitus patients

patients


Social skills improvement in children with high-functioning autism : a pilot randomized controlled trial . High-functioning autism ( HFA ) is characterized by persistent impairment in social interaction despite the absence of mental retardation . Although an increasing number of group-based programs for the improvement of social skills have been described , randomized controlled trials are needed to evaluate their efficacy . To compare the effect of a Social Skills Training Group-based Program ( SST-GP ) and a Leisure Activities Group-based Program ( LA-GP ) on the perception of facial emotions and quality of life ( QoL ) in young people with HFA . Eligible patients were children and adolescents with HFA . Participants were randomized to the SST or LA group . The primary outcome was defined as an improvement of 2 points in error rates for facial emotion labeling ( DANVA2 ) from baseline . After the 6-month training period , the SST Group made fewer errors in labeling anger on adult faces , whereas error rates in the LA Group remained stable . Progress in the ability to recognize anger in the SST Group was due to better recognition of low intensity stimuli on adult faces . QoL increased in the SST Group in the dimension of school environment , as a marker of the transfer of skills acquired in the treatment setting to their use in the community . The SST-GP had higher efficacy than the LA-GP . Data justify replication using larger samples .

SST

LA

SST

LA

SST

SST

SST-GP

LA-GP .

ability to recognize anger

QoL

efficacy

children

high-functioning autism

children and adolescents

HFA


Effect of duloxetine on pain , function , and quality of life among patients with chemotherapy-induced painful peripheral neuropathy : a randomized clinical trial . IMPORTANCE There are no known effective treatments for painful chemotherapy-induced peripheral neuropathy . OBJECTIVE To determine the effect of duloxetine , 60 mg daily , on average pain severity . DESIGN , SETTING , AND PATIENTS Randomized , double-blind , placebo-controlled crossover trial at 8 National Cancer Institute ( NCI ) -funded cooperative research networks that enrolled 231 patients who were 25 years or older being treated at community and academic settings between April 2008 and March 2011 . Study follow-up was completed July 2012 . Stratified by chemotherapeutic drug and comorbid pain risk , patients were randomized to receive either duloxetine followed by placebo or placebo followed by duloxetine . Eligibility required that patients have grade 1 or higher sensory neuropathy according to the NCI Common Terminology Criteria for Adverse Events and at least 4 on a scale of 0 to 10 , representing average chemotherapy-induced pain , after paclitaxel , other taxane , or oxaliplatin treatment . INTERVENTIONS The initial treatment consisted of taking 1 capsule daily of either 30 mg of duloxetine or placebo for the first week and 2 capsules of either 30 mg of duloxetine or placebo daily for 4 additional weeks . MAIN OUTCOME MEASURES The primary hypothesis was that duloxetine would be more effective than placebo in decreasing chemotherapy-induced peripheral neuropathic pain . Pain severity was assessed using the Brief Pain Inventory-Short Form " average pain " item with 0 representing no pain and 10 representing as bad as can be imagined . RESULTS Individuals receiving duloxetine as their initial 5-week treatment reported a mean decrease in average pain of 1.06 ( 95 % CI , 0.72-1.40 ) vs 0.34 ( 95 % CI , 0.01-0.66 ) among those who received placebo ( P = .003 ; effect size , 0.513 ) . The observed mean difference in the average pain score between duloxetine and placebo was 0.73 ( 95 % CI , 0.26-1.20 ) . Fifty-nine percent of those initially receiving duloxetine vs 38 % of those initially receiving placebo reported decreased pain of any amount . CONCLUSION AND RELEVANCE Among patients with painful chemotherapy-induced peripheral neuropathy , the use of duloxetine compared with placebo for 5 weeks resulted in a greater reduction in pain . TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00489411 .

duloxetine

duloxetine

duloxetine

placebo

placebo

duloxetine .

duloxetine

placebo

duloxetine

placebo

duloxetine

placebo

duloxetine

placebo

duloxetine

duloxetine

placebo

pain

function

quality of life

average pain severity .

pain

average pain

average pain score

pain

pain .

patients who were 25 years or older


Teacher and child predictors of achieving IEP goals of children with autism . It is encouraging that children with autism show a strong response to early intervention , yet more research is needed for understanding the variability in responsiveness to specialized programs . Treatment predictor variables from 47 teachers and children who were randomized to receive the COMPASS intervention ( Ruble et al . in The collaborative model for promoting competence and success for students with ASD . Springer , New York , 2012a ) were analyzed . Predictors evaluated against child IEP goal attainment included child , teacher , intervention practice , and implementation practice variables based on an implementation science framework ( Dunst and Trivette in J Soc Sci 8:143-148 , 2012 ) . Findings revealed one child ( engagement ) , one teacher ( exhaustion ) , two intervention quality ( IEP quality for targeted and not targeted elements ) , and no implementation quality variables accounted for variance in child outcomes when analyzed separately . When the four significant variables were compared against each other in a single regression analysis , IEP quality accounted for one quarter of the variance in child outcomes .

COMPASS intervention

children with autism .

children with autism

teachers and children


Bayesian adaptive trials offer advantages in comparative effectiveness trials : an example in status epilepticus . OBJECTIVE We present a novel Bayesian adaptive comparative effectiveness trial comparing three treatments for status epilepticus that uses adaptive randomization with potential early stopping . STUDY DESIGN AND SETTING The trial will enroll 720 unique patients in emergency departments and uses a Bayesian adaptive design . RESULTS The trial design is compared to a trial without adaptive randomization and produces an efficient trial in which a higher proportion of patients are likely to be randomized to the most effective treatment arm while generally using fewer total patients and offers higher power than an analogous trial with fixed randomization when identifying a superior treatment . CONCLUSION When one treatment is superior to the other two , the trial design provides better patient care , higher power , and a lower expected sample size .

Bayesian adaptive

Bayesian adaptive

Bayesian adaptive design .

patient care

power

expected sample size

status epilepticus .


[ Impact of CCND1 A870G polymorphism on acute adverse events in postoperative rectal cancer patients treated with adjuvant concurrent chemoradiotherapy ] . OBJECTIVE The purpose of this study was to investigate the association between single nucleotide polymorphism ( SNP ) of CCND1 A870G and acute adverse events ( AEs ) in postoperative rectal cancer patients who received capecitabine-based postoperative chemoradiotherapy ( CRT ) . METHODS Four hundred patients with stage II and III rectal cancer received postoperative CRT of capecitabine with or without oxaliplatin were accumulated and prostectively studied in this study . The patients were randomly divided into two groups . Two hundred and twenty-eight patients were treated with concurrent capecitabine and radiotherapy ( Cap-CRT ) , and 172 patients were treated with capecitabine and oxaliplatin plus radiotherapy ( Cap-Oxa-CRT ) . Adverse events were graded according to the Common Terminology Criteria for Adverse Events , v. 3.0 ( CTCAE v3.0 ) . The genotype of CCND1 A870G in the patients was detected by polymerase chain reaction-based restriction fragment length polymorphism ( PCR-RFLP ) analysis . The associations between the SNP and acute AEs were indicated by odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) , which were computed with logistic regression model . RESULTS A total of 136 patients presented severe AEs . Among them the frequencies of the three genotypes GG , GA and AA were 16.9 % , 50.7 % and 32.4 % , compared with 24.6 % , 48.1 % and 27.3 % , respectively , among the patients without severe AEs . Diarrhea was the most common AE , and severe diarrhea occurred in 109 patients . The frequencies of the three genotypes GG , GA and AA were 15.6 % , 47.7 % and 36.7 % among these patients , compared with 24.4 % , 49.5 % and 26.1 % , respectively , among patients without severe diarrhea . Multivariate logistic regression analysis showed a 1.66-fold increased risk for severe diarrhea in patients with AA genotype ( 95 % CI 1.03 - 2.67 , P = 0.038 ) compared with the cases with GG or GA genotypes . Stratified analysis showed that in the Cap-Oxa-CRT group , patients with AA genotype showed a 2.34-fold increased risk for severe diarrhea ( 95 % CI 1.16 - 4.76 , P = 0.018 ) compared with those with GG or GA genotypes , but in the Cap-CRT group , the SNP was not associated with the risk of severe diarrhea . CONCLUSIONS The genetic polymorphism of CCND1 A870G might be a potential biomarker for predicting acute AEs in postoperative stage II and III rectal cancer patients treated with adjuvant concurrent chemoradiotherapy of capecitabine and oxaliplatin .

chemoradiotherapy

capecitabine-based

chemoradiotherapy ( CRT )

capecitabine

oxaliplatin

capecitabine

radiotherapy

Cap-CRT

capecitabine

oxaliplatin

radiotherapy

Cap-Oxa-CRT

Cap-Oxa-CRT

Cap-CRT

chemoradiotherapy

capecitabine

oxaliplatin .

acute adverse events

acute adverse events ( AEs )

Adverse events

acute AEs

AEs .

AEs . Diarrhea

AE

severe diarrhea

severe diarrhea .

severe diarrhea

severe diarrhea

severe diarrhea .

acute AEs

Four hundred


Data mining the ScanBrit study of a gluten- and casein-free dietary intervention for children with autism spectrum disorders : behavioural and psychometric measures of dietary response . We previously reported results based on the examination of a gluten- and casein-free diet as an intervention for children diagnosed with an autism spectrum disorder as part of the ScanBrit collaboration . Analysis based on grouped results indicated several significant differences between dietary and non-dietary participants across various core and peripheral areas of functioning . Results also indicated some disparity in individual responses to dietary modification potentially indicative of responder and non-responder differences . Further examination of the behavioural and psychometric data garnered from participants was undertaken , with a view to determining potential factors pertinent to response to dietary intervention . Participants with clinically significant scores indicative of inattention and hyperactivity behaviours and who had a significant positive changes to said scores were defined as responders to the dietary intervention . Analyses indicated several factors to be potentially pertinent to a positive response to dietary intervention in terms of symptom presentation . Chronological age was found to be the strongest predictor of response , where those participants aged between 7 and 9 years seemed to derive most benefit from dietary intervention . Further analysis based on the criteria for original study inclusion on the presence of the urine compound , trans-indolyl-3-acryloylglycine may also merit further investigation . These preliminary observations on potential best responder characteristics to a gluten- and casein-free diet for children with autism require independent replication .

gluten- and casein-free diet

dietary intervention .

dietary intervention .

dietary intervention

dietary intervention .

gluten- and casein-free diet

behavioural and psychometric measures

response

children

autism spectrum disorders


Effect of simvastatin on hemostasis in patients with isolated hypertriglyceridemia . BACKGROUNDS/AIMS Elevated triglyceride levels seem to predispose to the earlier development and accelerated progression of coronary artery disease . In our study , we assessed for the first time whether simvastatin treatment affects coagulation and fibrinolysis in patients with isolated hypertriglyceridemia . METHODS The study included 39 patients with elevated triglyceride levels and peripheral artery sclerosis , treated for 90 days with either simvastatin ( 40 mg daily ) or placebo . Plasma lipids , glucose homeostasis markers and hemostasic variables were assessed at baseline and after treatment . RESULTS Simvastatin , but not placebo , administered to these patients reduced plasma levels/activity of fibrinogen ( from 3.5 ± 0.4 to 2.8 ± 0.3 g/l , p < 0.01 ) , factor VII ( from 144.2 ± 16.9 to 112.5 ± 14.0 % , p < 0.01 ) and plasminogen activator inhibitor-1 ( from 76.9 ± 13.5 to 50.2 ± 9.2 ng/ml , p < 0.001 ) , without a significant reduction in von Willebrand factor levels , and tended to prolong the prothrombin and partial thromboplastin times . CONCLUSION Our results suggest that statin treatment produces a multidirectional effect on coagulation and fibrinolysis in patients with isolated hypertriglyceridemia and that this treatment may bring some benefits to patients with elevated triglyceride levels .

simvastatin

simvastatin

simvastatin

placebo .

Simvastatin

placebo

coagulation and fibrinolysis

hemostasic variables

plasma levels/activity of fibrinogen


The effect of four different irrigation systems in the removal of a root canal sealer . OBJECTIVES The aim of this study was to compare the efficiency of sonic , ultrasonic , and hydrodynamic devices in the removal of a root canal sealer from the surface and from simulated irregularities of root canals . MATERIALS AND METHODS Fifty-three root canals with two standardized grooves in the apical and coronal parts of longitudinally split roots were covered with AH Plus root canal sealer . Compared were the effects of ( control ) syringe irrigation , ( 1 ) CanalBrush , ( 2 ) passive ultrasonic irrigation , ( 3 ) EndoActivator , and ( 4 ) RinsEndo on the removal of the sealer . The specimens were divided into four groups ( N = 12 ) and one control group ( N = 5 ) via randomization . The amount of remaining sealer in the root canal irregularities was evaluated under a microscope using a 4-grade scoring system , whereas the remaining sealer on the root canal surface was evaluated with a 7-grade scoring system . RESULTS Passive ultrasonic irrigation is more effective than the other tested irrigation systems or syringe irrigation in removing sealer from root canal walls ( p < 0.01 ) . None of the techniques had a significant effect on cleaning the lateral grooves . CONCLUSIONS Within the limitations of this study protocol ultrasonic irrigation shows a superior effect on sealer removal from the root canal surface during endodontic retreatment . Cleaning of lateral grooves seems not to be possible with one of the techniques investigated . CLINICAL RELEVANCE Incomplete removal of root canal sealer during re-treatment may cause treatment failure . Passive Ultrasonic irrigation seems to be the most effective system to remove sealer from a root canal .

syringe irrigation

CanalBrush

passive ultrasonic irrigation

EndoActivator

RinsEndo

Passive ultrasonic irrigation

irrigation systems

syringe irrigation

ultrasonic

Passive Ultrasonic

efficiency

Fifty-three


An open-label extension study of the safety and efficacy of risperidone in children and adolescents with autistic disorder . OBJECTIVE The purpose of this study was to evaluate the long-term safety and efficacy of risperidone in treating irritability and related behaviors in children and adolescents with autistic disorders . METHODS In this 6 month ( 26 week ) open-label extension ( OLE ) study , patients ( 5-17 years of age , who completed the previous fixed-dose , 6 week , double-blind [ DB ] phase ) were flexibly dosed with risperidone based on body weight . The maximum allowed dose was 1.25 mg/day for those weighing 20 to < 45 kg , and 1.75 mg/day for those weighing ≥ 45 kg . The study primarily assessed risperidone 's safety ; efficacy was assessed as a secondary end-point . RESULTS Fifty-six ( 71 % ) out of 79 enrolled patients completed the OLE ; the most common discontinuations were for insufficient response ( 7 [ 9 % ] ) or adverse events ( AE ) ( 5 [ 6 % ] ) . The most common ( ≥ 5 % frequency in the total group ) AEs were increased appetite ( 11 % [ n=9 ] ) ; increased weight and vomiting ( 9 % [ n=7 ] each ) ; sedation , pyrexia , and upper respiratory tract infection ( 8 % [ n=6 ] each ) ; nasopharyngitis ( 6 % [ n=5 ] ) ; and somnolence and fatigue ( 5 % [ n=4 ] each ) . Extrapyramidal AEs were reported in 6 ( 8 % ) patients . Increase in mean weight ( 11-15 % ) and body mass index ( 5-10 % ) occurred ; one patient discontinued because of weight increase . One potentially prolactin-related AE ( irregular menstruation ) was reported . The risperidone high-dose group had the greatest mean improvement in sleep visual analog scale ( 24.6 ) . All groups showed additional improvement in efficacy scale scores during the OLE . CONCLUSIONS During this OLE , safety findings with risperidone treatment ( maximum weight-based dose of 1.25 mg/day or 1.75 mg/day ) were consistent with those observed in the DB phase , and with the current safety information for risperidone in autistic , psychiatric , and behavioral disorders . Patients experienced some additional improvement in irritability and related behaviors . CLINICAL TRIALS REGISTRY This phase-4 study is registered at ClinicalTrials.gov ( NCT00576732 ) .

risperidone

risperidone

risperidone

risperidone

risperidone

safety

efficacy

adverse events

increased appetite

increased weight

vomiting

sedation

pyrexia

upper respiratory tract infection

nasopharyngitis

somnolence

fatigue

Extrapyramidal

weight

prolactin-related AE

irregular menstruation

sleep visual analog scale

efficacy

children and adolescents

autistic disorder

children and adolescents

autistic disorders

5-17 years of age


Inverse Effect of Fluoxetine on Medial Prefrontal Cortex Activation During Reward Reversal in ADHD and Autism . Attention deficit hyperactivity disorder ( ADHD ) and autism spectrum disorder ( ASD ) share brain function abnormalities during cognitive flexibility . Serotonin is involved in both disorders , and selective serotonin reuptake inhibitors ( SSRIs ) can modulate cognitive flexibility and improve behavior in both disorders . Thus , this study investigates shared and disorder-specific brain dysfunctions in these 2 disorders during reward reversal , and the acute effects of an SSRI on these . Age-matched boys with ADHD ( 15 ) , ASD ( 18 ) , and controls ( 21 ) were compared with functional magnetic resonance imaging ( fMRI ) during a reversal task . Patients were scanned twice , under either an acute dose of Fluoxetine or placebo in a double-blind , placebo-controlled randomized design . Repeated-measures analyses within patients assessed drug effects . Patients under each drug condition were compared with controls to assess normalization effects . fMRI data showed that , under placebo , ASD boys underactivated medial prefrontal cortex ( mPFC ) , compared with control and ADHD boys . Both patient groups shared decreased precuneus activation . Under Fluoxetine , mPFC activation was up-regulated and normalized in ASD boys relative to controls , but down-regulated in ADHD boys relative to placebo , which was concomitant with worse task performance in ADHD . Fluoxetine therefore has inverse effects on mPFC activation in ASD and ADHD during reversal learning , suggesting dissociated underlying serotonin abnormalities .

Fluoxetine

Fluoxetine

placebo

placebo

Fluoxetine

placebo

Fluoxetine

medial prefrontal cortex ( mPFC )

precuneus activation .

mPFC activation

task performance

mPFC activation


Economic burden of childhood autism spectrum disorders . OBJECTIVE To estimate the associations between autism spectrum disorder ( ASD ) diagnoses and service use , caregiver time , and cost outcomes . METHODS We used national data from the Medical Expenditure Panel Survey linked to the National Health Interview Survey and a study-specific survey to estimate the annual utilization and costs for health care , school , ASD-related therapy , family-coordinated services , as well as caregiver time in children aged 3 to 17 years , with and without parent-reported ASD . Regression analyses estimated the association between ASD diagnosis and cost , controlling for child gender , age , race/ethnicity , insurance status , household income , country region and urban/rural classification , and non-ASD-related illnesses . RESULTS Children with parent-reported ASD had higher levels of health care office visits and prescription drug use compared with children without ASD ( P < .05 ) . A greater proportion of children in the ASD group used special educational services ( 76 % vs. 7 % in the control group , P < .05 ) . After adjusting for child demographic characteristics and non-ASD-associated illnesses , ASD was associated with $ 3020 ( 95 % confidence interval [ CI ] : $ 1017- $ 4259 ) higher health care costs and $ 14,061 ( 95 % CI : $ 4390- $ 24,302 ) higher aggregate non-health care costs , including $ 8610 ( 95 % CI : $ 6595- $ 10,421 ) higher school costs . In adjusted analyses , parents who reported that their child had ASD did not have significantly higher out-of-pocket costs or spend more time on caregiving activities compared with control parents . CONCLUSIONS The economic burden associated with ASD is substantial and can be measured across multiple sectors of our society . Previous analyses that focused on health care underestimated this economic burden , particularly for school systems .

service use

caregiver time

cost outcomes

annual utilization

and

costs

health care

school

ASD-related therapy

family-coordinated services

caregiver time

cost

health care office visits

prescription drug use

special educational services

health care costs

non-health care costs

higher school costs

out-of-pocket costs

time on caregiving activities

childhood

autism spectrum disorders

autism spectrum disorder ( ASD )

children aged 3 to 17 years

parent-reported ASD

Children with parent-reported ASD


Assessment of acute bronchodilator effects from specific airway resistance changes in stable COPD patients . BACKGROUND In COPD patients , reversibility is currently evaluated from the changes of forced expiratory volume at 1s ( ΔFEV1 ) and forced vital capacity ( ΔFVC ) . By lowering peripheral airway smooth muscle tone , bronchodilators should decrease dynamic hyperinflation , gas trapping , and possibly dyspnea at rest . Hence , we hypothesize that specific airway resistance changes ( ΔsRAW ) should better characterize the acute response to bronchodilators . METHODS On two days , 60 COPD patients underwent dyspnea evaluation ( VAS score ) and pulmonary function testing at baseline and one hour after placebo or 300μg indacaterol administration . RESULTS Spirographic and ΔsRAW-based criteria identified as responders 24 and 45 patients , respectively . ΔsRAW correlated with changes of intrathoracic gas volume ( ΔITGV ) ( r=0.61 ; p < 0.001 ) , residual volume ( ΔRV ) ( r=0.60 ; p < 0.001 ) , ΔFVC ( r=0.44 ; p=0.001 ) , and ΔVAS ( r=0.73 ; p < 0.001 ) , while ΔFEV1 correlated only with ΔFVC ( r=0.34 ; p=0.008 ) . Significant differences in terms of ΔITGV ( p=0.002 ) , ΔRV ( p=0.023 ) , and ΔVAS ( p < 0.001 ) occurred only if patients were stratified according to ΔsRAW . CONCLUSIONS In assessing the acute functional effect of bronchodilators , ΔsRAW-based criterion is preferable to FEV1-FVC-based criteria , being more closely related to bronchodilator-induced improvements of lung mechanics and dyspnea at rest .

placebo

indacaterol

dyspnea evaluation ( VAS score )

pulmonary function

Spirographic

ΔsRAW-based

ΔsRAW

intrathoracic gas volume ( ΔITGV )

residual volume

ΔsRAW-based

stable COPD patients .

COPD patients

COPD


Youth with autism spectrum disorder comprehend lexicalized and novel primary conceptual metaphors . Individuals with autism spectrum disorder ( ASD ) have difficulty comprehending metaphors . However , no study to date has examined whether or not they understand conceptual metaphors ( i.e . mappings between conceptual structures ) , which could be the building blocks of metaphoric thinking and understanding . We investigated whether 13 participants with ASD ( age 7 ; 03-22 ; 03 ) and 13 age-matched typically developing ( TD ) controls could comprehend lexicalized conceptual metaphors ( e.g. , Susan is a warm person ) and novel ones ( e.g. , Susan is a toasty person ) . Individuals with ASD performed at greater than chance levels on both metaphor types , although their performance was lower than TD participants . We discuss the theoretical relevance of these findings and educational implications .

lexicalized

primary conceptual metaphors .

metaphors .

conceptual metaphors

lexicalized conceptual metaphors

metaphor

comprehending metaphors

conceptual metaphors

lexicalized conceptual metaphors

novel ones

metaphor

Youth

autism spectrum disorder

participants with ASD

age 7 ; 03-22 ; 03

Individuals with ASD


Paternal RHD zygosity determination in Tunisians : evaluation of three molecular tests . BACKGROUND The choice of a molecular test for first intention determination of paternal RHD zygosity , before entering into invasive diagnostics , is important for the management of pregnancies at risk of haemolytic disease of the foetus and newborn related to anti-RhD . MATERIALS AND METHODS RHD zygosity was evaluated in 370 RH:1 Tunisian donors by polymerase chain reaction - sequence-specific polymorphism ( PCR-SSP ) analysis and polymerase chain reaction - restriction fragment length polymorphism ( PCR-RFLP ) amplification of hybrid Rhesus box and by real time quantitative polymerase chain reaction ( RQ-PCR ) specific for RHD exon 5 . To evaluate the accuracy of molecular tests in the cases of discordant results , the ten exons of RHD and Rhesus boxes were amplified by PCR and sequenced . RESULTS Molecular investigations revealed that our 370 donors comprise 193 dizygous and 145 hemizygous individuals and 32 subjects whose zygosity remains unknown . Positive predictive values were higher than 99 % for all the methods , reaching 100 % for RQ-PCR . Negative predictive values were 83.24 % , 87.27 % and 98 % for PCR-SSP , PCR-RFLP and RQ-PCR respectively . This study also revealed 19 novel Rhesus box polymorphisms and three novel RHD alleles : RHD ( Trp185Stop ) , RHD ( Ala176Thr ) and RHD ( Ile342Ile ) . DISCUSSION RQ-PCR is the most convenient method for first intention determination of paternal RHD zygosity in Tunisians . However , taking into account positive and negative predictive values , PCR-RFLP could be an alternative despite the heterogeneity of Rhesus boxes and the complexity of RHD .

molecular test

RQ-PCR

PCR-RFLP

Positive predictive values

Negative predictive values

Rhesus box polymorphisms

RHD alleles :

Tunisians :

Tunisian donors

370 donors


A randomized controlled study of a social skills training for preadolescent children with autism spectrum disorders : generalization of skills by training parents and teachers ? BACKGROUND Social skills training ( SST ) is a common intervention for children with autism spectrum disorders ( ASDs ) to improve their social and communication skills . Despite the fact that SSTs are often applied in clinical practice , the evidence for the effectiveness of these trainings for children with ASD is inconclusive . Moreover , long term outcome and generalization of learned skills are little evaluated . Additionally , there is no research on the influence of involvement of parents and teachers on effectiveness of SST and on the generalization of learned social skills to daily life . We expect parent and teacher involvement in SST to enhance treatment efficacy and to facilitate generalization of learned skills to daily life . METHOD/DESIGN In a randomized controlled trial ( RCT ) with three conditions , 120 participants with ASD at the end of primary school ( 10-12 years of calendar age ) have been randomized to SST , SST-PTI ( SST with Parent & Teacher Involvement ) , or care-as-usual . The SST consists of 18 group sessions of 1.5 hours for the children . In the SST-PTI condition , parents additionally participate in 8 parent sessions and parents and teachers are actively involved in homework assignments . Assessment takes place at three moments : before and immediately after the intervention period and at 6 months follow-up . Primary outcome is socialization , as an aspect of adaptive functioning . Secondary outcomes focus on specific social skills children learn during SST and on more general social skills pertaining to home and community settings from a multi-informant perspective . Additionally , possible predictors of treatment outcome will be assessed . DISCUSSION The current study is an RCT study evaluating SST in a large sample of Dutch children with ASD in a specific age range ( 10-12 years ) . Strengths of the study are the use of one manualized protocol , application of standardized and internationally used rating instruments , use of multiple raters , investigation of generalization of learned skills to daily life , and the evaluation of efficacy in the longer term by follow-up measures at 6 months after the end of training . TRIAL REGISTRATION NTR2405 .

social skills training

Social skills training ( SST )

SSTs

SST

SST

care-as-usual .

SST

SST-PTI

SST

SST

socialization

specific social skills

general social skills

preadolescent children

autism spectrum disorders

children with ASD

10-12 years of calendar age

Dutch

children

with ASD in a

specific age range ( 10-12 years )


Safety and preliminary immunogenicity of Cuban pneumococcal conjugate vaccine candidate in healthy children : a randomized phase I clinical trial . A new heptavalent conjugate vaccine ( PCV7-TT ) is under development in Cuba . PCV7-TT contains 2 μg of serotypes 1 , 5 , 14 , 18C , 19F , 23F and 4 μg of 6B , each one conjugated to tetanus toxoid ( TT ) . This vaccine was designed with the serotypes that cause most invasive pneumococcal diseases ( IPD ) worldwide . In the present study , we investigated the safety and explored the immunogenicity of PCV7-TT during a controlled , randomized and double blind clinical trial phase I in 4-5-year-old children . PCV7-TT was well tolerated and as safe as Synflorix used as control vaccine . Following a single-dose vaccination , all individual serotypes included in PCV7-TT induced statistically significant increase of IgG GMC and OPA GMT . These are the first clinical results of PCV7-TT in children and they pave the way toward next clinical trials in children and infants . This clinical trial was published in the Cuban Public Register of Clinical Trials with code RPCEC00000173 .

Cuban pneumococcal conjugate vaccine

Synflorix

Safety

preliminary immunogenicity

safety

immunogenicity

IgG GMC

OPA GMT

healthy children

4-5-year-old children


Atomoxetine in autism spectrum disorder : no effects on social functioning ; some beneficial effects on stereotyped behaviors , inappropriate speech , and fear of change . UNLABELLED Abstract Objective : The objective of this study was to investigate the short-term treatment effects of atomoxetine on autism spectrum disorder ( ASD ) symptoms in children and adolescents with both ASD and attention-deficit/hyperactivity disorder ( ADHD ) . METHODS A total of 97 patients 6-17 years of age , with ASD and ADHD , were treated with 1.2 mg/kg/day of atomoxetine during an 8 week double-blind placebo-controlled period . Here , we investigated effects on two parent-based secondary outcome measures , the Aberrant Behavior Checklist ( ABC ) and the Children 's Social Behavior Questionnaire ( CSBQ ) . RESULTS After 8 weeks of double-blind treatment , atomoxetine administration was associated with significant treatment effects on the ABC subscales Hyperactivity , Inappropriate Speech , and Stereotypic Behavior , and on the CSBQ subscale Fear for Changes . CONCLUSIONS Our study results indicate no beneficial effects of atomoxetine on social functioning . However , atomoxetine may ameliorate restricted and stereotyped behaviors and communication . This study has been registered in ClinicalTrials.gov ( www.clinicaltrials.gov ) under registration number NCT00380692 .

Atomoxetine

atomoxetine

atomoxetine

placebo-controlled

atomoxetine

atomoxetine

social functioning ;

stereotyped behaviors

inappropriate speech

fear of change

ABC subscales Hyperactivity

Inappropriate Speech

Stereotypic Behavior

CSBQ subscale Fear for Changes

stereotyped behaviors

communication

autism spectrum disorder :

children and adolescents

6-17 years of age

ASD and ADHD


Randomised trial of text messaging on adherence to cardiovascular preventive treatment ( INTERACT trial ) . BACKGROUND About one third of patients prescribed blood pressure or lipid-lowering drugs for the prevention of coronary heart disease and stroke do not take their medication as prescribed . We conducted a randomized trial to evaluate text messaging as a means of improving adherence to cardiovascular disease preventive treatment . METHODS 303 patients taking blood pressure and/or lipid-lowering medications were randomly assigned to being sent text messages ( Text group , 151 ) or not being sent them ( No text group , 152 ) . Texts were sent daily for 2 weeks , alternate days for 2 weeks and weekly thereafter for 22 weeks ( 6 months overall ) , using an automated computer programme . Patients were asked to respond on whether they had taken their medication , whether the text reminded them to do so if they had forgotten , and if they had not taken their medication to determine if there was a reason for not doing so . At 6 months , use of medication was assessed . RESULTS Two patients were lost to follow-up , providing data on 301 for analysis . In the No text group 38/151 ( 25 % ) took less than 80 % of the prescribed regimen ( ie . stopped medication completely or took it on fewer than 22 of the last 28 days of follow-up ) compared to 14/150 patients ( 9 % ) in the Text group - an improvement in adherence affecting 16 per 100 patients ( 95 % CI 7 to 24 ) , p < 0.001 . The texts reminded 98/151 patients ( 65 % ) to take medication on at least one occasion and lead to 20/151 ( 13 % ) who stopped taking medication because of concern over efficacy or side-effects , resuming treatment . CONCLUSIONS In patients taking blood pressure or lipid-lowering treatment for the prevention of cardiovascular disease , text messaging improved medication adherence compared with no text messaging . TRIAL REGISTRATION Controlled-Trials.com ISRCTN74757601 .

text messaging

text messages ( Text

not being sent them

Text

text messaging

no text messaging .

adherence

adherence

adherence

medication adherence


Regional ventricular performance and exercise training in children and young adults after repair of tetralogy of Fallot : randomized controlled pilot study . BACKGROUND Public-health guidelines recommend patients with congenital heart disease to exercise . Studies have shown that patients with congenital heart disease can improve physical exercise capacity . The effect of training on regional ventricular performance has hardly been studied . We performed a pilot study to assess whether an exercise training program would result in adverse changes of regional ventricular performance in patients with corrected tetralogy of Fallot . METHODS AND RESULTS Multicenter prospective randomized controlled pilot study in patients with tetralogy of Fallot aged 10 to 25 years . A 12-week standardized aerobic dynamic exercise training program ( 3 one-hour sessions per week ) was used . Pre- and post-training cardiopulmonary exercise tests , MRI , and echocardiography , including tissue-Doppler imaging , were performed . Patients were randomized to the exercise group ( n=28 ) or control group ( n=20 ) . One patient in the exercise group dropped out . Change in tissue-Doppler imaging parameters was similar in the exercise group and control group ( change in right ventricle free wall peak velocity E ' exercise group , 0.8±2.6 cm/s ; control group , 0.9±4.1 ; peak velocity A ' exercise group , 0.4±2.4 m/s ; control group 4.6±18.1 cm/s ) . CONCLUSIONS This randomized controlled pilot study provides preliminary data suggesting that regional ventricular performance is well maintained during 3-month aerobic dynamic exercise training in children and young adults with repaired tetralogy of Fallot . This information might help patients adhere to current public-health guidelines . CLINICAL TRIAL REGISTRATION URL : http// : www.trialregister.nl . Unique identifier : NTR2731 .

exercise training

training

exercise training program

exercise training program

exercise

control

exercise

exercise

control

exercise training

children and young

patients with tetralogy of Fallot

aged 10 to 25 years


Subjective and objective levels of physical activity and their association with cardiorespiratory fitness in rheumatoid arthritis patients . INTRODUCTION The aims of the present study were : ( a ) to examine the agreement between subjective ( assessed via the International Physical Activity Questionnaire ; IPAQ ) and objective ( accelerometry ; GT3X ) physical activity ( PA ) levels in patients with rheumatoid arthritis ( RA ) , and ( b ) to evaluate the associations of RA patients ' subjective and objective PA to their scores on the maximal oxygen uptake test ( VO2max ) . METHODS The participants wore the GT3X for seven days before completing the IPAQ and VO2max test . The Bland-Altman plot was used to illustrate the agreement between the objective and subjective PA data , and the Wilcoxon test was employed to examine the differences . The association between the PA measurement and VO2max test was examined via the correlations and the magnitude was presented by the Steiger 's Z value . RESULTS Sixty-eight RA patients ( age=55±13 years , body mass index : 27.8±5.4 kg/m2 , median of disease duration=5 ( 2-8 ) yrs ) were recruited . Smaller differences between the subjective and objective measures were found when PA was assessed at the moderate level . Wilcoxon tests revealed that patients reported less time spent engaged in sedentary behaviours ( Z=-6.80 , P < 0.01 ) and light PA ( Z=-6.89 , P < 0.01 ) and more moderate PA ( Z=-6.26 , P < 0.01 ) than was objectively indicated . Significant positive correlations were revealed between VO2max with all PA levels derived from accelerometry ( light PA rho=.35 , P < .01 ; moderate PA rho=.34 , P=.01 ; moderate and vigorous PA , ( MVPA ) rho=.33 , P=.01 ) , and a negative association to sedentary time ( ST ) emerged ( rho=-.27 , P=.04 ) . IPAQ-reported moderate PA and MVPA positively correlated with maxV02 ( rho=.25 , P=.01 , rho=.27 , P=.01 , respectively ) . Differences between the magnitude of correlations between the IPAQ-VO2 max and GT3X-VO2 max were only significant for ST ( Z=3.43 , P < .01 ) . CONCLUSIONS Via responses to the IPAQ , RA patients reported that they were less sedentary and engaged in more higher intensity PA than what was objectively assessed . Accelerometry data correlated with VO2max at all PA levels . Only subjective moderate and MPVA correlated with VO2max . Findings suggest that self-reported PA and ST should be interpreted with caution in people with RA and complemented with accelerometry when possible . TRIAL REGISTRATION Trial registration : ClinicalTrials.gov ISRCTN04121489 . Registered 5 September 2012 .

PA

GT3X ) physical activity ( PA )

maximal oxygen uptake test ( VO2max )

IPAQ

PA measurement

PA

sedentary behaviours

light PA

PA levels

sedentary time

IPAQ-reported

PA

MVPA

IPAQ-VO2 max

GT3X-VO2 max

rheumatoid arthritis patients .

Sixty-eight

RA

age=55±13 years


A randomised controlled trial of personalised decision support delivered via the internet for bowel cancer screening with a faecal occult blood test : the effects of tailoring of messages according to social cognitive variables on participation . BACKGROUND In Australia , bowel cancer screening participation using faecal occult blood testing ( FOBT ) is low . Decision support tailored to psychological predictors of participation may increase screening . The study compared tailored computerised decision support to non-tailored computer or paper information . The primary outcome was FOBT return within 12 weeks . Additional analyses were conducted on movement in decision to screen and change on psychological variables . METHODS A parallel , randomised controlled , trial invited 25,511 people aged 50-74 years to complete an eligibility questionnaire . Eligible respondents ( n = 3,408 ) were assigned to Tailored Personalised Decision Support ( TPDS ) , Non-Tailored PDS ( NTPDS ) , or Control ( CG ) ( intention-to-treat , ITT sample ) . TPDS and NTPDS groups completed an on-line baseline survey ( BS ) and accessed generic information . The TPDS group additionally received a tailored intervention . CG participants completed a paper BS only . Those completing the BS ( n = 2270 ) were mailed an FOBT and requested to complete an endpoint survey ( ES ) that re-measured BS variables ( per-protocol , PP sample ) . RESULTS FOBT return : In the ITT sample , there was no significant difference between any group ( χ ( 2 ) ( 2 ) = 2.57 , p = .26 ; TPDS , 32.5 % ; NTPDS , 33 % ; and CG , 34.5 % ) . In the PP sample , FOBT return in the internet groups was significantly higher than the paper group ( χ ( 2 ) ( 2 ) = 17.01 , p < .001 ; TPDS , 80 % ; NTPDS , 83 % ; and CG , 74 % ) . FOBT completion by TPDS and NTPDS did not differ ( χ ( 2 ) ( 1 ) = 2.23 , p = .13 ) . Age was positively associated with kit return . Decision to screen : 2227/2270 of the PP sample provided complete BS data . Participants not wanting to screen at baseline ( 1083/2227 ) and allocated to TPDS and NTPDS were significantly more likely to decide to screen and return an FOBT than those assigned to the CG . FOBT return by TPDS and NTPDS did not differ from one another ( OR = 1.16 , p = .42 ) . Change on psychosocial predictors : Analysis of change indicated that salience and coherence of screening and self-efficacy were improved and faecal aversion decreased by tailored messaging . CONCLUSIONS Online information resources may have a role in encouraging internet-enabled people who are uncommitted to screening to change their attitudes , perceptions and behaviour . TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12610000095066 .

personalised decision support

tailored computerised decision support

Non-Tailored PDS ( NTPDS )

Control

TPDS

NTPDS

tailored intervention

FOBT return

aged 50-74


Sedation during endoscopic retrograde cholangiopancreatography : a randomized controlled study of patient-controlled propofol sedation and that given by a nurse anesthetist . OBJECTIVE Different regimens are used for sedation during endoscopic retrograde cholangiopancreatography ( ERCP ) . Our objectives were to compare safety , ease of treatment , recovery , and patients ' experiences using patient-controlled sedation ( PCS ) with propofol , nurse anesthetist-controlled sedation ( ACS ) , or the department 's standard of care , midazolam given by the procedure team ( control group ) . MATERIAL AND METHODS The study included 281 adults in 301 procedures . The PCS group ( n = 101 ) delivered bolus doses of 5 mg of propofol according to their need for sedation . The ACS group ( n = 100 ) had 2-8 mg/kg/h of propofol infused , with the target for sedation being level 3 of the Observer 's Assessment of Alertness/Sedation ( OAA/S ) scale . The control group was given 2-3 mg of midazolam for induction and additional 1 mg if required . RESULTS PCS and ACS increased the ease of the procedure and reduced the number of sedation failures compared to midazolam sedation ( ACS n = 0 ; PCS n = 4 ; midazolam n = 20 ) . The ACS group had more deeply sedated patients ( OAA/S level 2 ) , desaturation , and obstructed airways than the PCS and midazolam groups . Time to full recovery ( Aldrete score ≥9 ) was shortest following PCS . PCS resulted in the least fatigue and pain after the procedure . Patients ' preference for PCS and ACS was the same . CONCLUSION PCS with propofol is superior to midazolam and comparable to ACS . PCS resulted in a rapid recovery , fewer respiratory events , and was almost as effective as ACS in ensuring a successful examination .

propofol

patient-controlled sedation

propofol

anesthetist-controlled sedation

standard of care

midazolam

propofol

propofol

midazolam

midazolam

midazolam

midazolam

propofol

midazolam

safety

ease of treatment

recovery

patients ' experiences

ease of the procedure

number of sedation failures

Time to full recovery ( Aldrete score

retrograde cholangiopancreatography :

adults


Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism Spectrum Disorders : A Randomized Controlled Pilot Study . This pilot and feasibility study examined the impact of a sensory adapted dental environment ( SADE ) to reduce distress , sensory discomfort , and perception of pain during oral prophylaxis for children with autism spectrum disorder ( ASD ) . Participants were 44 children ages 6-12 ( n = 22 typical , n = 22 ASD ) . In an experimental crossover design , each participant underwent two professional dental cleanings , one in a regular dental environment ( RDE ) and one in a SADE , administered in a randomized and counterbalanced order 3-4 months apart . Outcomes included measures of physiological anxiety , behavioral distress , pain intensity , and sensory discomfort . Both groups exhibited decreased physiological anxiety and reported lower pain and sensory discomfort in the SADE condition compared to RDE , indicating a beneficial effect of the SADE .

Sensory Adapted Dental Environments

regular dental environment ( RDE )

SADE

SADE

RDE

SADE .

distress

sensory discomfort

perception of pain

physiological anxiety

behavioral distress

pain intensity

sensory discomfort

physiological anxiety

pain

sensory discomfort

Children

Autism Spectrum Disorders

children

autism spectrum disorder ( ASD )

children ages 6-12

n = 22 typical , n = 22 ASD


The effects of preoperative oral pregabalin and perioperative intravenous lidocaine infusion on postoperative morphine requirement in patients undergoing laparatomy . OBJECTIVES To evaluate and compare the effects of preoperative oral pregabalin and perioperative intravenous lidocaine infusion on postoperative morphine requirement , adverse effects , patients ' satisfaction , mobilization , time to first defecation and time to discharge in patients undergoing laparotomy . METHODS Eighty patients ( 18 to 65 years of age ) undergoing elective laparotomy were randomly divided into four groups ( n=20 in each group ) : group C , placebo capsules and normal saline infusion perioperatively ( control ) ; group L , placebo capsules and lidocaine 1 mg⁄kg intravenous bolus dose followed by 2 mg⁄kg⁄h infusion until skin closure ; group P , 150 mg oral pregabalin and normal saline infusion perioperatively ; and group PL , 150 & nbsp ; mg oral pregabalin and lidocaine 2 mg⁄kg⁄h infusion until skin closure . Hemodynamic parameters , visual analogue scale ( VAS ) scores , analgesic consumption , side effects , time to mobilization , time to first defecation , time to discharge and patients ' satisfaction were recorded . RESULTS VAS scores of group L , group P and group PL were lower than group C ( P < 0.05 ) . Morphine consumption of group P and group PL was lower than group C ( P < 0.05 ) . Incidence of nausea in group C was higher than group L and group PL . Time to first defecation and mobilization were shorter in group L and group PL compared with group C ( P < 0.05 ) . CONCLUSION Preoperative oral pregabalin and perioperative intravenous lidocaine infusion decreased postoperative VAS scores . Preoperative oral pregabalin decreased morphine requirement and perioperative intravenous lidocaine infusion hastened gastrointestinal motility and mobilization , and decreased the incidence of nausea in patients undergoing laparotomy . Therefore , preoperative pregabalin with or without lidocaine provides superior pain relief in patients undergoing laparatomy .

pregabalin

lidocaine

pregabalin

lidocaine

placebo

normal saline infusion

placebo

lidocaine

pregabalin

normal saline infusion

pregabalin

lidocaine

pregabalin

lidocaine

pregabalin

lidocaine

pregabalin

postoperative morphine requirement

postoperative morphine requirement

adverse effects

patients ' satisfaction

mobilization

time to first defecation

time to discharge

Morphine consumption

Time to first defecation

mobilization

morphine requirement

patients undergoing laparatomy .

Eighty

18 to 65 years of age

undergoing elective laparotomy


A New Interactive Screening Test for Autism Spectrum Disorders in Toddlers . OBJECTIVE To develop a clinically valid interactive level 2 screening assessment for autism spectrum disorders ( ASD ) in toddlers that is brief , easily administered , and scored by clinicians . STUDY DESIGN We describe the development , training , standardization , and validation of the Rapid Interactive Screening Test for Autism in Toddlers ( RITA-T ) with ASD-specific diagnostic instruments . The RITA-T can be administered and scored in 10 minutes . We studied the validity of the RITA-T to distinguish between toddlers with ASD from toddlers with developmental delay ( DD ) /non-ASD in an early childhood clinic . We also evaluated the test 's performance in toddlers with no developmental concerns . We identified a cutoff score based on sensitivity , specificity , and positive predictive value of the RITA-T that best differentiates between ASD and DD/non-ASD . RESULTS A total of 61 toddlers were enrolled . RITA-T scores were correlated with ASD-specific diagnostic tools ( r = 0.79 ; P < .01 ) and ASD clinical diagnoses ( r = 0.77 ; P < .01 ) . Mean scores were significantly different in subjects with ASD , those with DD/non-ASD , and those with no developmental concerns ( 20.8 vs 13 vs 10.6 , respectively ; P < .0001 ) . At a cutoff score of > 14 , the RITA-T had a sensitivity of 1.00 , specificity of 0.84 , and positive predictive value of 0.88 for identifying ASD risk in a high-risk group . CONCLUSION The RITA-T is a promising new level 2 interactive screening tool for improving the early identification of ASD in toddlers in general pediatric and early intervention settings and allowing access to treatment .

Interactive Screening Test

Rapid Interactive Screening Test

RITA-T

RITA-T

RITA-T

RITA-T

RITA-T

cutoff score

sensitivity

specificity

, and

positive predictive value

RITA-T

RITA-T scores

scores

Autism Spectrum Disorders

Toddlers

autism spectrum disorders ( ASD )

toddlers

toddlers

with no developmental concerns .

A total of 61 toddlers

ASD in toddlers


Inference-Based Approach versus Cognitive Behavioral Therapy in the Treatment of Obsessive-Compulsive Disorder with Poor Insight : A 24-Session Randomized Controlled Trial . OBJECTIVE Obsessive-compulsive disorder ( OCD ) with poor insight has severe consequences for patients ; nonetheless , no randomized controlled trial has ever been performed to evaluate the effectiveness of any treatment specifically for poor-insight OCD . A new psychotherapy for OCD , the inference-based approach ( IBA ) , targets insight in OCD by strengthening normal sensory-driven reality testing . The goal of the present study is to compare the effectiveness of this new treatment to the effectiveness of cognitive behavior therapy ( CBT ) for patients with OCD with poor insight . METHOD A randomized controlled trial was conducted , in which 90 patients with OCD with poor insight received either 24 CBT sessions or 24 IBA sessions . The primary outcome measure was the Yale-Brown Obsessive Compulsive Scale ( YBOCS ) . Secondary outcome measures were level of insight , anxiety and depressive symptoms , and quality of life . Mixed-effects models were used to determine the treatment effect . RESULTS In both conditions , a significant OCD symptom reduction was reached , but no condition effects were established . Post hoc , in a small subgroup of patients with the worst insight ( n = 23 ) , it was found that the patients treated with the IBA reached a significantly higher OCD symptom reduction than the patients treated with CBT [ estimated marginal mean = -7.77 , t ( 219.45 ) = -2.4 , p = 0.017 ] . CONCLUSION Patients with OCD with poor insight improve significantly after psychological treatment . The results of this study suggest that both CBT and the IBA are effective treatments for OCD with poor insight . The IBA might be more promising than CBT for patients with more extreme poor insight .

Inference-Based Approach

Cognitive Behavioral Therapy

inference-based approach ( IBA )

cognitive behavior therapy ( CBT )

CBT

IBA

IBA

CBT

CBT

IBA

IBA

CBT

OCD symptom reduction

OCD symptom reduction

patients with OCD with poor insight .

patients with OCD with poor insight

Patients with OCD with poor insight


[ The effect of ionic and nonionic x-ray contrast media on myocardial perfusion and myocardial function ] . The influence of injections of Amidotrizoate and Iopromide into the left coronary artery on global myocardial perfusion and function ( pressures in the left ventricle , heart rate ) as well as excitation formation and transmission was studied in 16 patients with ischaemic heart disease . No statistically significant differences in myocardial perfusion measured were found with xenon-133 in this small group between rest and dipyridamole load for ionic and non-ionic contrast media .

ionic

nonionic x-ray contrast

Amidotrizoate

Iopromide

myocardial

myocardial perfusion

patients with ischaemic heart disease


[ The sympatho-adrenergic stress reaction in ear surgery using various anesthesia technics ] . The aim of the present study was to investigate the effects of various anaesthetic procedures on the endocrine stress responses during ear microsurgical operations . Simple mastoidectomies , radical mastoidectomies and tympano plastics were carried out in 49 patients under the following randomised anaesthetic procedures : Group 1 halothane anaesthesia and retroauricular infiltration anaesthesia with lidocaine and ornipressin ( n = 14 ) , Group 2 fentanyl anaesthesia and retroauricular anaesthesia with lidocaine and ornipressin ( n = 10 ) , Group 3 fentanyl anaesthesia and retroauricular infiltration anaesthesia with lidocaine and epinephrine ( n = 14 ) , and Group 4 retroauricular infiltration anaesthesia with prilocaine and epinephrine ( n = 14 ) . The plasma levels of epinephrine , norepinephrine , glucose , lactate and free glycerol were measured in addition to mean arterial pressure ( MAP ) and heart rate ( HR ) immediately before anaesthesia , 10 minutes after skin incision , 10 minutes after having started bone drilling , at the end of the operation and 3 hours after operation . All data were subjected to covariance analysis including the age factor . Plasma catecholamine concentrations remained within the normal range during the investigation in patients subjected to general anaesthesia ( Groups 1-3 ) . Plasma catecholamines ( epinephrine and norepinephrine ) increased significantly in Group 4 ( retroauricular infiltration anaesthesia ) . There were no group variabilities with regard to MAP and HR . The plasma levels of epinephrine and norepinephrine demonstrate a direct response to stress followed by a secondary change in glucose , lactate and free glycerol . The beneficial effect of general anaesthesia is documented by normal plasma levels of epinephrine and norepinephrine throughout the operation . ( ABSTRACT TRUNCATED AT 250 WORDS )

halothane

lidocaine

ornipressin

fentanyl

lidocaine

ornipressin

fentanyl

lidocaine

epinephrine

prilocaine

epinephrine

Plasma catecholamine concentrations

MAP

HR .

glucose , lactate and free glycerol .

ear surgery


Low doses of ketazolam in anxiety : a double-blind , placebo-controlled study . A multicenter , double-blind , between-patient trial comparing two doses of ketazolam ( 15 and 30 mg ) with placebo , each given once daily , in the evening , to 92 outpatients affected by generalized anxiety disorders for at least 1 month , was carried out . After 1-week washout period 47 patients were randomized to ketazolam 15 mg , and 45 to placebo for 15 days ( first period ) . At the end of this period , if the patient experienced a decrease on the total Hamilton Anxiety Rating Scale ( HAM-A ) of at least 25 % of basal value , the treatment was kept unchanged for a further 15 days , otherwise 15 mg of ketazolam were added to the previous treatment ( second period ) . Anxiety was rated after 2 and 4 weeks with the Italian HAM-A scale and with a 4-point scale ( patient 's assessment ) . Seventy-eight patients completed the first period and 75 the whole study . During the first period the percentage of responders was almost identical in both treatment groups , but during the second period a further slight improvement was observed in the early placebo responders , while the HAM-A score of patients on ketazolam continued to improve significantly ( p less than 0.01 ) throughout the study . Likewise a significant ( p less than 0.001 ) difference between treatments was observed , on the 4-point scale , in the population as a whole ( end of first period ) as well as in responder patients ( end second period ) . Tolerability was good , except in 1 patient on placebo , who was withdrawn from the study because of severe headache .

ketazolam

ketazolam

placebo

ketazolam

placebo

ketazolam

placebo

ketazolam

placebo

Italian HAM-A scale

HAM-A score

4-point scale

severe headache .

anxiety :

Seventy-eight


Levobunolol compared with timolol : a four-year study . Fifty-one patients with raised intraocular pressure ( IOP ) were treated for up to four years with one of three ophthalmic solutions : 0.5 % levobunolol , 1 % levobunolol , or 0.5 % timolol . The study was conducted as a double-masked , randomised trial in which medications were administered twice daily to both eyes . Levobunolol and timolol were equally effective in reducing overall mean IOP ; reductions were greater than 8.8 mmHg in all three treatment groups . The study showed levobunolol to be as safe and effective as timolol in the long-term control of raised IOP .

Levobunolol

timolol :

levobunolol

levobunolol

timolol .

Levobunolol

timolol

levobunolol

timolol

overall mean IOP ;

Fifty-one

patients

raised intraocular pressure ( IOP )


Role of angiotensin-converting enzyme inhibitors in early antihypertensive treatment in non-insulin dependent diabetes mellitus . The effect of captopril monotherapy on blood pressure and metabolism was investigated in a placebo-controlled study in 30 non-insulin dependent ( Type II ) diabetic subjects during a 3-week observation period ( run-in/drug ; placebo/wash-out ) on a metabolic ward . Captopril significantly reduced both systolic and diastolic blood pressure ( 154/90 +/- 5/2 vs. 144/86 +/- 4/3 mmHg ) without major side effects . Mean run-in postprandial blood glucose concentrations were also reduced upon ACE-inhibition ( 9 a.m. : 12.7 +/- 0.4 vs. 11.1 +/- 0.4 mmol/l ; 1 p.m. : 11.0 +/- 0.3 vs. 8.9 +/- 0.3 mmol/l ; P less than 0.05 ) , while blood kinin concentrations ( 40.0 +/- 2.5 pmol/l ) were approximately doubled ( 108.8 +/- 23.5 pmol/l ; P less than 0.05 ) . Body mass index , fasting plasma insulin , serum electrolyte pattern , uric acid , white blood count , lipid profile as well as hepatic and renal function parameters remained unaltered throughout the observation period . The data are in line with recent experimental studies showing a beneficial metabolic effect of captopril in Type II diabetes . ACE inhibitors might therefore become first-line drugs in early antihypertensive intervention in Type II diabetic patients .

captopril

placebo-controlled

Captopril

captopril

ACE inhibitors

blood pressure

metabolism

systolic and diastolic blood pressure

blood kinin concentrations

hepatic and renal function

Type II diabetic


Double-blind comparison of doxepin versus bupropion in outpatients with a major depressive disorder . A double-blind controlled study comparing the effects of bupropion to doxepin in outpatients with primary depression was conducted to evaluate efficacy and safety differences between the two drugs . Following a 7-day placebo washout period , patients could be treated for up to 13 weeks on either treatment . Antidepressant response was assessed by the Hamilton Depression and Anxiety Scales , Clinical Global Severity and Improvement Ratings , and the Zung Self-Rating Depression Scale . Comparable efficacy between the compounds was found across the 13-week study . Doxepin differed from bupropion mainly on the sleep factor of the Hamilton Depression Scale , with doxepin improving sleep to a greater extent than bupropion . Doxepin produced a greater incidence of anticholinergic side effects , including dry mouth , constipation , sleepiness , and tiredness , in comparison to bupropion . Also , increased appetite and weight gain were consistent side effects of doxepin relative to bupropion .

doxepin

bupropion

bupropion

doxepin

placebo

Doxepin

bupropion

doxepin

bupropion . Doxepin

bupropion .

doxepin

bupropion .

efficacy

safety

Antidepressant response

Hamilton Depression and Anxiety Scales

Zung Self-Rating Depression Scale

efficacy

sleep

Hamilton Depression Scale

sleep

anticholinergic side effects

appetite and weight gain

outpatients with primary depression