The effect of the use of oxytocin on blood loss during different postpartum periods . OBJECTIVE Postpartum hemorrhage is the most important reason for maternal mortality . In developed countries , the reason of 13 % of maternal deaths is postpartum hemorrhage while this percentage reaches more than 30 % in other countries . In this study , the effect of oxytocin use in different times at the 3rd stage of delivery on changes in the postpartum hemoglobin levels was compared . DESIGN AND SETTING In the study , 89 pregnant women to whom oxytocin was administered after placenta separation were studied in Group 1 , 89 pregnant women were included in Group 2 , and oxytocin was administered after delivery of the shoulder . The levels of hemoglobin and hematocrit before and after delivery were quantified . RESULTS The biochemical parameters were examined , there was no significant statistical differences in the levels of hemoglobin and hemotocrit before delivery between the two groups . When compared to Group 1 , Δ-hemoglobin ( P= > 0.001 ) , Δ-hematocrit ( P= > 0.001 ) , the change between the prepartum and postpartum hemoglobin percentage ( P < =0.001 ) , and change between the prepartum and postpartum hemotocrit percentage ( P < =0.001 ) were statistically lower in Group 2 . CONCLUSIONS It was determined that the use of oxytocin after shoulder delivery has more effects on decreasing the amount of postpartum hemorrhage .

oxytocin

oxytocin

postpartum hemoglobin levels

levels of hemoglobin and hematocrit

levels of hemoglobin and hemotocrit

of postpartum hemorrhage

Postpartum hemorrhage

women

89 pregnant

women


Improving adolescent social competence and behavior : a randomized trial of an 11-week equine facilitated learning prevention program . There is growing evidence that promoting social competence in youth is an effective strategy to prevent mental , emotional , and behavioral disorders in adulthood . Research suggests that programs delivered in collaboration with schools are particularly effective when they target social and emotional skill building , utilize an interactive instructional style , provide opportunities for youth participation and self-direction , and include explicit attempts to enhance youth social competence . A relatively new but popular approach that incorporates these characteristics is human animal interaction , which can be implemented in educational settings . We report the results from a randomized clinical trial examining the effects of an 11-week equine facilitated learning ( EFL ) program on the social competence and behavior of 5th-8th grade children . Children ( N = 131 ) were recruited through referral by school counselors and school-based recruitment and then screened for low social competence . Researchers randomly assigned children to an experimental ( n = 53 ) or waitlisted control group ( n = 60 ) . Children in the experimental group participated in an 11-week EFL program consisting of once-weekly , 90-min sessions of individual and team-focused activities , whereas children in the control group served as a wait-listed control and participated 16 weeks later . Parents of children in both groups rated child social competence at pretest and posttest . Three independent raters observed and reported children 's positive and negative behavior using a validated checklist during each weekly session . Results indicated that program participation had a moderate treatment effect ( d = .55 ) on social competence ( p = .02 ) that was independent of pretest levels , age , gender , and referral status . Results showed that higher levels of program attendance predicted children 's trajectories of observed positive ( β = .500 ; p = .003 ) and negative behavior ( β = -.062 ; p < .001 ) over the 11-week program .

promoting social competence

human animal interaction

waitlisted control group

EFL program

control group

wait-listed control

child social competence

adolescent

youth

5th-8th grade children

Children


Changes in motor cortex excitability associated with temporal repetitive transcranial magnetic stimulation in tinnitus : hints for cross-modal plasticity ? BACKGROUND Motor cortex excitability was found to be changed after repetitive transcranial magnetic stimulation ( rTMS ) of the temporal cortex highlighting the occurrence of cross-modal plasticity in non-invasive brain stimulation . Here , we investigated the effects of temporal low-frequency rTMS on motor cortex plasticity in a large sample of tinnitus patients . In 116 patients with chronic tinnitus different parameters of cortical excitability were assessed before and after ten rTMS treatment sessions . Patients received one of three different protocols all including 1 Hz rTMS over the left temporal cortex . Treatment response was defined as improvement by at least five points in the tinnitus questionnaire ( TQ ) . Variables of interest were resting motor threshold ( RMT ) , short-interval intra-cortical inhibition ( SICI ) , intracortical facilitation ( ICF ) , and cortical silent period ( CSP ) . RESULTS After rTMS treatment RMT was decreased by about 1 % of stimulator output near-significantly in the whole group of patients . SICI was associated with significant changes with respect to treatment response . The group of treatment responders showed a decrease of SICI over the course of treatment , the group of non-responders the reverse pattern . CONCLUSIONS Minor RMT changes during rTMS treatment do not necessarily suggest the need for systematic re-examination of the RMT for safety and efficacy issues . Treatment response to rTMS was shown to be related to changes in SICI that might reflect modulation of GABAergic mechanisms directly or indirectly related to rTMS treatment effects .

temporal low-frequency rTMS

rTMS

rTMS

rTMS

rTMS

resting motor threshold ( RMT )

intracortical facilitation ( ICF )

cortical silent period ( CSP )

RMT was decreased

SICI

decrease of SICI

Minor RMT changes

tinnitus

tinnitus

tinnitus


Patients with relapsed follicular lymphoma treated with rituximab versus tositumomab and iodine I-131 tositumomab .

rituximab

tositumomab

iodine I-131 tositumomab

with relapsed follicular lymphoma


Evaluation of postprocedure cognitive function using 3 distinct standard sedation regimens for endoscopic procedures . The primary purpose of this investigation was to evaluate postprocedure cognitive function associated with 3 distinct standard sedation regimens used for endoscopic procedures . A secondary aim was to identify complications requiring provider interventions . Subjects scheduled for colonoscopies were approached for enrollment the day of their procedure . A convenience sample of 96 subjects was randomly assigned . Cognitive function was recorded on the day of surgery using the Mini-Mental State Examination ( MMSE ) and 24 and 48 hours postoperatively using the Telephone Interview of Cognitive Status ( TICS ) . The propofol plus fentanyl group had a mean TICS score of 34.53 at 24 hours compared with 34.96 at 48 hours ( P = .017 ) . The midazolam plus fentanyl group had a mean TICS score of 34.76 at 24 hours compared with 36.26 at 48 hours ( P = .004 ) . The propofol-alone group had a mean TICS score of 35.09 at 24 hours compared with 35.98 at 48 hours ( P = .924 ) . The results of this investigation indicate that the sedation regimen of propofol alone has the least impact on postprocedure cognitive function . Additionally , the number of jaw lift interventions was significantly higher in both groups who received fentanyl .

sedation regimens

standard sedation regimens

Mini-Mental State Examination

Telephone Interview of Cognitive Status

propofol plus fentanyl

midazolam plus fentanyl

propofol-alone

propofol

fentanyl

cognitive function

postprocedure cognitive function

mean TICS score

mean TICS score

mean TICS score

postprocedure cognitive function

number of jaw lift interventions

scheduled for colonoscopies


Intramedullary repair device against volar plating in the reconstruction of extra-articular and simple articular distal radius fractures ; a randomized pilot study . PURPOSE This prospective randomized pilot study reports our institutional experience and early results using Sonoma Wrx ( Sonoma Orthopedic Products , Santa Rosa , CA ) in the treatment of extra-articular and simple intra-articular distal radius fractures . MATERIAL AND METHODS A total of 64 patients , were enrolled in the study . They were considered eligible if they had ; unstable extra-articular distal radius fractures and simple intra-articular distal radius fractures suitable for closed reduction ( AO types ; A2.2 , A2.3 , A3.1 C2.1 , C2.2 ) . Patients in group I received intramedullary fixation using the Sonoma Wrx device and patients in group II received standard volar locking plate fixation . Radiographic criteria of acceptable healing were used for evaluation . RESULTS Two groups were similar in terms of baseline characteristics . Mean time of operation was significantly shorter in Group 1 vs. in group 2 ( 36.81 ± 7.11 vs. 48.97 ± 5.9 minutes , p = 0.001 ) . Time to healing of the fracture was not different between two groups ( 5.45 ± 1.09 vs. 5.70 ± 1.04 weeks for Group 1 vs. 2 , respectively p = 0.36 ) . Overall complications occurred in 9 patients in group 1 and in 15 patients in group 2 ( p = 0.17 ) . Follow-up was completed in all patients with a median time of 12 months and 13 months in group 1 and 2 , respectively . On radiographic evaluation radial inclination , radial height and volar tilt were not significantly different between group 1 and 2 , respectively . There were no significant differences between two groups in regard to wrist rotational degrees measured in last follow-up visit . CONCLUSION Sonoma Wrx Device is reliable and effective in terms of achieving satisfactory outcomes in treatment of distal radius fractures . It may be reasonable to use this device to prevent complications that are related to extensive soft tissue dissection .

Intramedullary repair

standard volar locking plate fixation

fractures suitable


A brief adherence intervention that improved glycemic control : mediation by patterns of adherence . This study examined whether longitudinal adherence profiles mediated the relationship between a brief adherence intervention and glycemic control among patients with type 2 diabetes . Adherence was assessed using the Medication Event Monitoring System . Longitudinal analysis via growth curve mixture modeling was carried out to classify patients according to patterns of adherence to oral hypoglycemic agents . Hemoglobin A1c assays were used to measure glycemic control as the clinical outcome . Across the whole sample , longitudinal adherence profiles mediated 35.2 % ( 13.2 , 81.0 % ) of the effect of a brief adherence intervention on glycemic control [ from odds ratio ( OR ) = 8.48 , 95 % confidence interval ( CI ) ( 3.24 , 22.2 ) to 4.00 , 95 % CI ( 1.34 , 11.93 ) ] . Our results suggest that patients in the intervention had better glycemic control largely due to their greater likelihood of adherence to oral hypoglycemic agents .

brief adherence intervention

adherence intervention

Adherence

adherence to oral hypoglycemic agents

glycemic control

glycemic control

glycemic control

glycemic control

type 2 diabetes


Antibacterial effects of fluoride varnish compared with chlorhexidine plus fluoride in disabled children . PURPOSE To evaluate the effects of fluoride varnish vs a combination of chlorhexidine-thymol varnish plus a gel containing chlorhexidine and fluoride on oral hygiene and caries prevention in disabled children . MATERIALS AND METHODS Ninety patients aged 3-17 years who were treated under general anaesthesia were randomly assigned into three groups as follows : group 1 : Fluor Protector ( 0.1 % fluoride varnish ) ; group 2 : Cervitec Plus ( 1 % chlorhexidine- 1 % thymol varnish ) + Cervitec Gel ( 0.2 % chlorhexidine-0.2 % sodium fluoride ) ; group 3 : control ( toothbrushing only ) . Mutans streptococci ( MS ) and lactobacilli ( LB ) levels , visible plaque index ( VPI ) and gingival bleeding index ( GBI ) were evaluated at four stages : T0 , before general anaesthesia ; T1 , one month after treatment ; T2 , six months after treatment ; T3 , twelve months after treatment . The data were evaluated using Kruskal-Wallis and Mann-Whitney U-tests ( P < 0.05 ) . RESULTS Groups 1 and 2 showed significantly lower scores than group 3 for all parameters at T1 and T2 . No statistically significant difference was detected among any of the the groups at T3 ( P > 0.05 ) . CONCLUSION The use of materials that include both fluoride and chlorhexidine as routine treatment of children with disability may increase the success of restorations by improving oral hygiene , reduce the need for future restorative treatments and thus the need for general anaesthesia .

Antibacterial effects

Kruskal-Wallis and Mann-Whitney U-tests

significantly lower scores

No statistically significant difference

children .

children .

Ninety patients

3-17 years

anaesthesia

children

disability


Mechanical sensitivity of the human conjunctiva . PURPOSE The aim of this study was to map the sensitivity of the marginal and other conjunctival regions and to investigate changes in the sensitivity of these regions when determined in the morning and evening . METHODS Thirty-five healthy , noncontact lens wearers ( 20 female , 15 male ; age 27.7 ± 7.3 years ) were enrolled . Mechanical sensitivity was measured at 8 locations on the ocular surface and adnexa ( cornea , marginal , bulbar , and tarsal conjunctiva ) using a Cochet-Bonnet esthesiometer ( 0.12-mm diameter filament ) . A subgroup of 11 subjects ( 6 female , 5 male ; age 28.9 ± 9.9 years ) returned after 12 hours when this protocol was repeated . RESULTS The cornea was found to be the most sensitive region ( all P < 0.001 ) . The marginal conjunctiva showed greater sensitivity than did the bulbar and tarsal conjunctiva ( all P < 0.001 ) . The temporal marginal conjunctiva was more sensitive than the central marginal conjunctiva ( all P < 0.05 ) . No difference in marginal conjunctival sensitivity was found between upper and lower eyelids ( all P > 0.05 ) . The upper tarsal conjunctiva was more sensitive than the lower tarsal conjunctiva ( P = 0.04 ) . There was no significant difference in the sensitivity determined in the morning and the evening for any of the locations investigated ( Bonferroni adjusted , P > 0.006 ) . CONCLUSIONS This work has demonstrated that the marginal conjunctiva was the most sensitive of all the conjunctival regions and that this does not alter over the course of the day .

marginal conjunctiva

marginal conjunctival sensitivity

upper tarsal conjunctiva

marginal conjunctiva


Quantifying narrative ability in autism spectrum disorder : a computational linguistic analysis of narrative coherence . Autism is a neurodevelopmental disorder characterized by serious difficulties with the social use of language , along with impaired social functioning and ritualistic/repetitive behaviors ( American Psychiatric Association in Diagnostic and statistical manual of mental disorders : DSM-5 , 5th edn . American Psychiatric Association , Arlington , 2013 ) . While substantial heterogeneity exists in symptom expression , impairments in language discourse skills , including narrative ( or storytelling ) , are universally observed in autism ( Tager-Flusberg et al . in Handbook on autism and pervasive developmental disorders , 3rd edn . Wiley , New York , pp 335-364 , 2005 ) . This study applied a computational linguistic tool , Latent Semantic Analysis ( LSA ) , to objectively characterize narrative performance in high-functioning individuals with autism and typically-developing controls , across two different narrative contexts that differ in the interpersonal and cognitive demands placed on the narrator . Results indicated that high-functioning individuals with autism produced narratives comparable in semantic content to those produced by controls when narrating from a picture book , but produced narratives diminished in semantic quality in a more demanding narrative recall task . This pattern is similar to that detected from analyses of hand-coded picture book narratives in prior research , and extends findings to an additional narrative context that proves particularly challenging for individuals with autism . Results are discussed in terms of the utility of LSA as a quantitative , objective , and efficient measure of narrative ability .

computational linguistic tool

Latent Semantic Analysis ( LSA )

narrative ability

narratives

narratives

narrative ability .

autism spectrum disorder :

Autism

high-functioning

autism

high-functioning

autism

autism


PTK2 expression and immunochemotherapy outcome in chronic lymphocytic leukemia . Addition of rituximab ( R ) to fludarabine and cyclophosphamide ( FC ) has significantly improved patient outcomes in chronic lymphocytic leukemia ( CLL ) . Whether baseline gene expression can identify patients who will benefit from immunochemotherapy over chemotherapy alone has not been determined . We assessed genome-wide expression of 300 pretreatment specimens from a subset of 552 patients in REACH , a study of FC or R-FC in relapsed CLL . An independent test set was derived from 282 pretreatment specimens from CLL8 , a study of FC or R-FC in treatment-naïve patients . Genes specific for benefit from R-FC were determined by assessing treatment-gene interactions in Cox proportional hazards models . REACH patients with higher pretreatment protein tyrosine kinase 2 ( PTK2 ) messenger RNA levels derived greater benefit from R-FC , with significant improvements in progression-free survival , independent of known prognostic factors in a multivariate model . Examination of PTK2 gene expression in CLL8 patients yielded similar results . Furthermore , PTK2 inhibition blunted R-dependent cell death in vitro . This retrospective analysis from 2 independent trials revealed that increased PTK2 expression is associated with improved outcomes for CLL patients treated with R-FC vs FC . PTK2 expression may be a useful biomarker for patient selection in future trials . These trials were registered at www.clinicaltrials.gov as # NCT00090051 ( REACH ) and # NCT00281918 ( CLL8 ) .

FC

R-FC

patient outcomes

genome-wide expression

progression-free survival

R-dependent cell death

chronic lymphocytic leukemia

chronic lymphocytic leukemia

CLL

CLL


Failure of lithium to reduce period of neutropenia during induction therapy of acute myeloid leukemia . Fifty-four patients treated with daunorubicin , cytosine arabinoside and thioquanine for acute myeloid leukemia were randomly assigned to receive oral lithium carbonate 1200 mg daily or no lithium . The duration of neutropenia ( less than 0.5 x 10 ( 9 ) /L ) was similar between controls ( median 22.5 days ) and patients treated with lithium ( median 24 days ) . The number of remissions , relapse-free survival and survival were similar for the lithium treated and control groups of patients . There was no apparent clinical efficacy in the use of lithium to reduce the period of neutropenia in patients undergoing remission induction therapy for acute myeloid leukemia .

induction therapy

daunorubicin

cytosine arabinoside

thioquanine

oral lithium carbonate 1200 mg daily

no lithium

lithium

lithium

lithium

induction therapy

duration of neutropenia

number of remissions

relapse-free survival

survival

clinical efficacy

acute myeloid leukemia

Fifty-four


Balance training in elderly women using public parks . This study evaluates the effects of a balance training program developed in public parks on functionality and general state of health in elderly women . It was a randomized controlled trial . Women older than 65 years ( n = 28 ; 68.5 ± 2.9 ) participated in a balance training program that lasted 6 weeks , with sessions taking place twice a week ( 12 exercises/session , 50 min ) . Balance was analyzed by the Berg Balance Scale and Timed Up & Go Test . The generic health status was measured by the SF-12 Health Survey . These tests showed statistically significant differences in the experimental group ( p < .05 ) . Public parks are adequate installations for developing balance .

balance training program

Balance

The generic health status


Video-feedback Intervention to promote Positive Parenting adapted to Autism ( VIPP-AUTI ) : A randomized controlled trial . In a randomized controlled trial , we evaluated the early intervention program Video-feedback Intervention to promote Positive Parenting adapted to Autism ( VIPP-AUTI ) with 78 primary caregivers and their child ( 16-61 months ) with Autism Spectrum Disorder . VIPP-AUTI is a brief attachment-based intervention program , focusing on improving parent-child interaction and reducing the child 's individual Autism Spectrum Disorder-related symptomatology in five home visits . VIPP-AUTI , as compared with usual care , demonstrated efficacy in reducing parental intrusiveness . Moreover , parents who received VIPP-AUTI showed increased feelings of self-efficacy in child rearing . No significant group differences were found on other aspects of parent-child interaction or on child play behavior . At 3-months follow-up , intervention effects were found on child-initiated joint attention skills , not mediated by intervention effects on parenting . Implementation of VIPP-AUTI in clinical practice is facilitated by the use of a detailed manual and a relatively brief training of interveners .

Video-feedback Intervention

Video-feedback Intervention

VIPP-AUTI

attachment-based intervention program

VIPP-AUTI

VIPP-AUTI

VIPP-AUTI

parent-child interaction

efficacy

increased feelings of self-efficacy

No

child-initiated joint attention skills

Autism

78 primary caregivers

child ( 16-61 months )

Autism Spectrum Disorder


Variations in EEG discharges predict ADHD severity within individual Smith-Lemli-Opitz patients . OBJECTIVE We sought to examine the prevalence of EEG abnormalities in Smith-Lemli-Opitz syndrome ( SLOS ) as well as the relationship between interictal epileptiform discharges ( IEDs ) and within-subject variations in attentional symptom severity . METHODS In the context of a clinical trial for SLOS , we performed cross-sectional and repeated-measure observational studies of the relationship between EEG findings and cognitive/behavioral factors on 23 children ( aged 4-17 years ) . EEGs were reviewed for clinical abnormalities , including IEDs , by readers blinded to participants ' behavioral symptoms . Between-group differences in baseline characteristics of participants with and without IEDs were analyzed . Within-subject analyses examined the association between the presence of IEDs and changes in attention-deficit/hyperactivity disorder ( ADHD ) symptoms . RESULTS Of 85 EEGs , 43 ( 51 % ) were abnormal , predominantly because of IEDs . Only one subject had documented clinical seizures . IEDs clustered in 13 subjects ( 57 % ) , whereas 9 subjects ( 39 % ) had EEGs consistently free of IEDs . While there were no significant group differences in sex , age , intellectual disability , language level , or baseline ADHD symptoms , autistic symptoms tended to be more prevalent in the " IED " group ( according to Autism Diagnostic Observation Schedule-2 criteria ) . Within individuals , the presence of IEDs on a particular EEG predicted , on average , a 27 % increase in ADHD symptom severity . CONCLUSIONS Epileptiform discharges are common in SLOS , despite a relatively low prevalence of epilepsy . Fluctuations in the presence of epileptiform discharges within individual children with a developmental disability syndrome may be associated with fluctuations in ADHD symptomatology , even in the absence of clinical seizures .

EEG discharges

EEG

EEGs

EEG discharges

abnormal

clinical seizures .

ADHD symptom severity .

Smith-Lemli-Opitz syndrome ( SLOS )

aged 4-17 years


Chocolate frogs do not increase completion of parent survey : randomised study . Four months into a year-long , national survey assessing parents ' experiences of a child 's diagnosis of autism spectrum disorder , our response fraction was only 23 % . We aimed to determine whether including a chocolate incentive in the postal survey would increase the response fraction . Families enrolled between 15 March and 25 May 2012 were randomised to receive a chocolate frog versus no chocolate frog . Both groups received a written reminder and replacement survey 2 weeks after the survey was posted and up to two telephone reminders thereafter . We analysed the effect of the incentive using χ ( 2 ) tests for the categorical response variable and t-tests for the continuous reminder and length of response variables at the end of ( i ) randomisation and ( ii ) the study ( 1 November 2012 ) . A total of 137 families were randomised in the 6-week period . Parents who received an incentive were more likely to return a completed survey in the 6 weeks than those who did not ( 21 % vs. 6 % , P = 0.009 ) . This effect faded by the end of the study ( 53 % vs. 42 % , P = 0.4 ) . There were no differences between groups at either follow-up in the number of reminders that parents received or the number of days it took parents to return the survey . Including a chocolate-based incentive does not significantly increase response rate in a postal survey over and above standard reminder techniques like posting follow-up survey packs or phoning families .

Chocolate frogs

chocolate incentive

chocolate frog

versus

no chocolate frog

written reminder

increase the response fraction .

effect

χ ( 2 ) tests

and t-tests

received

number

significantly increase response

Families

A total of 137 families


COPD detected with screening : impact on patient management and prognosis . It is uncertain whether screening of older persons for chronic obstructive pulmonary disease ( COPD ) is worthwhile because the effects on patient management and prognosis are unknown . We aimed to assess the short-term consequences of detecting COPD in frail elderly subjects with dyspnoea , considering pulmonary drug use , hospitalisations and all-cause mortality . Community-dwelling frail elderly subjects , aged 65 years and older , with dyspnoea , participating in a screening study on COPD and heart failure were included . Final diagnoses were assigned by an expert panel based on all data from the screening strategy , including spirometry . Follow-up data were collected from the general practitioners . Of the 386 patients , 84 ( 21.8 % ) were received a new diagnosis of COPD . Overall , changes in pulmonary drug prescription during 6 months of follow-up were infrequent ( n = 53 , 13.7 % ; among new cases of COPD , 15 ( 17.9 % ) out of 84 ) . Of all participants , 25.9 % were hospitalised in the first year of follow-up , with the highest rate in patients with newly detected COPD ( 32.1 % ) . Many new cases of COPD could be detected by screening frail elderly subjects with dyspnoea , but the impact on patient management seems limited . Our study underlines the importance of obtaining follow-up data to assess the true impact of a ( screen-detected ) diagnosis of COPD on patient management and outcome .

spirometry

patient management and prognosis .

patient management and prognosis

pulmonary drug use

hospitalisations

all-cause mortality

changes in pulmonary drug prescription

hospitalised

dyspnoea

patient management

patient management and outcome .


36-month treatment experience of two doses of leuprolide acetate 3-month depot for children with central precocious puberty . CONTEXT We have recently demonstrated short-term ( 6-month ) efficacy and safety of leuprolide acetate 3-month depot 11.25 and 30 mg in children with central precocious puberty ( CPP ) . OBJECTIVE To assess long-term ( 36-month ) hypothalamic-pituitary-gonadal axis suppression and safety of leuprolide acetate 3-month depot 11.25 and 30 mg in children with CPP . DESIGN Open-label , 36-month extension . SETTING Twenty pediatric endocrine centers . PATIENTS Seventy-two children ( mean age , 8.5 ± 1.6 y ; 65 females ) with CPP completed and showed maintenance of LH suppression after a 6-month lead-in study . INTERVENTION Leuprolide acetate depot ( 11.25 or 30 mg ) administered im every 3 months . MAIN OUTCOME MEASURES Peak-stimulated LH , estradiol , T , growth rate , pubertal progression , and adverse events ( AEs ) . RESULTS Twenty-nine of 34 subjects in the 11.25-mg group and 36 of 38 subjects in the 30-mg group had LH values < 4 mIU/mL after day 1 at all time points . All seven subjects who escaped LH suppression at any time still maintained sex steroid concentrations at prepubertal levels and showed no signs of pubertal progression . AEs were comparable between groups , with injection site pain being the most common ( 26.4 % overall ) . No AE led to discontinuation of study drug . The safety profile over 36 months was comparable to that observed during the 6-month pivotal study . CONCLUSIONS The two doses of leuprolide acetate 3-month depot were associated with an acceptable safety profile and provided maintenance of LH suppression in the majority of children with CPP during the 36 months of the study or until readiness for puberty .

leuprolide acetate 3-month depot

leuprolide acetate 3-month depot

leuprolide acetate 3-month depot

safety

showed maintenance of LH suppression

Peak-stimulated LH

estradiol

T

growth rate

pubertal progression

adverse events ( AEs )

had

LH values

LH suppression

maintained sex steroid concentrations

of pubertal progression

AEs

with injection site pain

No AE

The safety profile

an acceptable safety profile

provided maintenance of LH suppression


A randomized , phase II study of afatinib versus cetuximab in metastatic or recurrent squamous cell carcinoma of the head and neck . BACKGROUND Afatinib is an oral , irreversible ErbB family blocker that has shown activity in epidermal growth factor receptor ( EGFR ) -mutated lung cancer . We hypothesized that the agent would have greater antitumor activity compared with cetuximab in recurrent or metastatic ( R/M ) head and neck squamous cell carcinoma ( HNSCC ) patients , whose disease has progressed after platinum-containing therapy . PATIENTS AND METHODS An open-label , randomized , phase II trial was conducted in 43 centers ; 124 patients were randomized ( 1 : 1 ) to either afatinib ( 50 mg/day ) or cetuximab ( 250 mg/m ( 2 ) /week ) until disease progression or intolerable adverse events ( AEs ) ( stage I ) , with optional crossover ( stage II ) . The primary end point was tumor shrinkage before crossover assessed by investigator ( IR ) and independent central review ( ICR ) . RESULTS A total of 121 patients were treated ( 61 afatinib , 60 cetuximab ) and 68 crossed over to stage II ( 32 and 36 respectively ) . In stage I , mean tumor shrinkage by IR/ICR was 10.4 % /16.6 % with afatinib and 5.4 % /10.1 % with cetuximab ( P = 0.46/0.30 ) . Objective response rate was 16.1 % /8.1 % with afatinib and 6.5 % /9.7 % with cetuximab ( IR/ICR ) . Comparable disease control rates were observed with afatinib ( 50 % ) and cetuximab ( 56.5 % ) by IR ; similar results were seen by ICR . Most common grade ≥3 drug-related AEs ( DRAEs ) were rash/acne ( 18 % versus 8.3 % ) , diarrhea ( 14.8 % versus 0 % ) , and stomatitis/mucositis ( 11.5 % versus 0 % ) with afatinib and cetuximab , respectively . Patients with DRAEs leading to treatment discontinuation were 23 % with afatinib and 5 % with cetuximab . In stage II , disease control rate ( IR/ICR ) was 38.9 % /33.3 % with afatinib and 18.8 % /18.8 % with cetuximab . CONCLUSION Afatinib showed antitumor activity comparable to cetuximab in R/M HNSCC in this exploratory phase II trial , although more patients on afatinib discontinued treatment due to AEs . Sequential EGFR/ErbB treatment with afatinib and cetuximab provided sustained clinical benefit in patients after crossover , suggesting a lack of cross-resistance .

afatinib

cetuximab

antitumor activity

independent central review ( ICR )

mean tumor shrinkage by IR/ICR

Comparable disease control rates

124 patients

121 patients

61 afatinib

60 cetuximab

68 crossed over to stage II


The effects of prism adaptation on egocentric metric distance estimation . OBJECTIVE The present experiment evaluated whether training involving throwing transferred to metric distance estimation ( i.e. , describing in feet and inches the distance between oneself and targets ) . BACKGROUND In prior work , we found that metric estimation training negatively transferred to throwing . We explained our results in terms of cognitive intrusion . The present study tested that possibility by swapping our training and transfer tasks . METHOD During pretesting , participants verbally estimated the metric distances between themselves and targets , or they threw a beanbag to targets . During training , participants donned goggles that distorted their vision . While wearing the goggles , they threw a beanbag to targets . Half received feedback . During posttesting , participants removed the distorting goggles and completed the same task that they performed during pretesting . RESULTS The results indicated that the distorting goggles degraded throwing at the beginning of training , visual feedback improved throwing during training , the effects of training with feedback persisted into the throwing posttest , and the effects of training with feedback did not transfer to the verbal metric estimation posttest . CONCLUSION Training involving throwing was effective , but did not transfer to verbal metric distance estimation . This supports our argument that the negative transfer observed in our previous study stemmed from cognitive intrusion . APPLICATION The present experiment suggests that the creation of distance estimation training should begin with a careful analysis of the transfer task , and that distance estimation training programs should explicitly teach trainees that their training will not generalize to all distance estimation tasks .

verbally estimated the metric distances

threw a beanbag to targets

participants donned goggles

threw a beanbag to targets

goggles

effects

metric distance estimation .

verbal metric estimation

throwing

effective

verbal metric distance estimation .

trainees that their training


Elevation of HDL-C in response to statin treatment is involved in the regression of carotid atherosclerosis . AIM Atherosclerosis is strongly associated with an increased mortality in subjects with diabetes . The carotid intima-media thickness ( IMT ) is commonly measured as a surrogate marker for cardiovascular risk . Statins are well-established protective agents against atherosclerosis and reportedly suppress IMT progression in subjects with diabetes . To clarify the effects of statins on subclinical atherosclerosis , we herein investigated changes in the carotid IMT and lipid profiles in a multi-center , prospective , randomized trial . METHODS Hypercholesterolemic subjects with type 2 diabetes were randomly assigned to open-label treatment with either pravastatin or pitavastatin . The primary endpoint of this study was the IMT change after 36 months of statin treatment . RESULTS A total of 97 subjects ( 51 pitavastatin ; 46 pravastatin ) completed this 36-month study . The LDL-C decreased significantly from 163.4 ± 27.9 mg/dl at baseline to 100.4 ± 19.6 mg/dl at 36 months in the pitavastatin group and from 159.7 ± 25.6 mg/dl to 118.5 ± 22.1 mg/dl in the pravastatin group . The mean IMT showed moderate regression in both the pitavastatin ( -0.070 ± 0.215 mm , P < 0.05 ) and the pravastatin ( -0.067 ± 0.260 mm ) group . However , there was no significant difference in the IMT change between the two groups . When the two groups were combined , the 36-month change in the mean IMT was significantly associated with HDL-C change ( r=-0.24 , P= 0.03 ) . Multiple linear regression analysis revealed the change in HDL-C to be an independent variable showing a positive correlation with the carotid IMT reduction . CONCLUSION The administration of statins for 3 years to subjects with type 2 diabetes resulted in a significant regression of the carotid IMT . An elevation of the plasma HDL-C with statin treatment was closely related to a regression of atherosclerosis .

statin

pravastatin

pitavastatin

statin

pitavastatin

pravastatin

pitavastatin

pravastatin

carotid intima-media thickness ( IMT )

IMT change

LDL-C

The mean

in the IMT change

the mean

associated with HDL-C change

change in

the carotid

the plasma

carotid atherosclerosis

diabetes

type 2 diabetes


Metal release and metal allergy after total hip replacement with resurfacing versus conventional hybrid prosthesis . BACKGROUND Metal-on-metal ( MOM ) total hip arthroplasties were reintroduced because of the problems with osteolysis and aseptic loosening related to polyethylene wear of early metal-on-polyethylene ( MOP ) arthroplasties . The volumetric wear rate has been greatly reduced with MOM arthroplasties ; however , because of nano-size wear particles , the absolute number has been greatly increased . Thus , a source of metal ion exposure with the potential to sensitize patients is present . We hypothesized that higher amounts of wear particles result in increased release of metal ions and ultimately lead to an increased incidence of metal allergy . METHODS 52 hips in 52 patients ( median age 60 ( 51-64 ) years , 30 women ) were randomized to either a MOM hip resurfacing system ( ReCap ) or a standard MOP total hip arthoplasty ( Mallory Head/Exeter ) . Spot urine samples were collected preoperatively , postoperatively , after 3 months , and after 1 , 2 , and 5 years and tested with inductively coupled plasma-sector field mass spectrometry . After 5 years , hypersensitivity to metals was evaluated by patch testing and lymphocyte transformation assay . In addition , the patients answered a questionnaire about hypersensitivity . RESULTS A statistically significant 10- to 20-fold increase in urinary levels of cobalt and chromium was observed throughout the entire follow-up in the MOM group . The prevalence of metal allergy was similar between groups . INTERPRETATION While we observed significantly increased levels of metal ions in the urine during the entire follow-up period , no difference in prevalence of metal allergy was observed in the MOM group . However , the effect of long-term metal exposure remains uncertain .

total hip replacement with resurfacing

conventional

hybrid prosthesis

Metal-on-metal ( MOM ) total

hip arthroplasties

MOM hip resurfacing system ( ReCap )

MOM

MOM

Metal release

metal allergy

release of metal ions

incidence of metal allergy

hypersensitivity to metals

hypersensitivity

urinary levels of cobalt and chromium

metal allergy

levels of metal ions in the urine

prevalence of metal allergy

total hip replacement with resurfacing

Metal-on-metal ( MOM )

30 women


A randomized , prospective , parallel group study of laparoscopic versus laparoendoscopic single site donor nephrectomy for kidney donation . Few prospective , randomized studies have assessed the benefits of laparoendoscopic single site donor nephrectomy ( LESS-DN ) over laparoscopic donor nephrectomy ( LDN ) . Our center initiated such a trial in January 2011 , following subjects randomized to LESS-DN versus LDN from surgery through 5 years postdonation . Subjects complete recovery/satisfaction questionnaires at 2 , 6 and 12 months postdonation ; transplant recipient outcomes are also recorded . One hundred subjects ( 49 LESS-DN , 51 LDN ) underwent surgery ; donor demographics were similar between groups , and included a predominance of female , living-unrelated donors , mean age of 47 years who underwent left donor nephrectomy . Operative parameters ( overall time , time to extraction , warm ischemia time , blood loss ) were similar between groups . Conversion to hand-assist laparoscopy was required in 3 LESS-DN ( 6.1 % ) versus 2 LDN ( 3.9 % ; p = 0.67 ) . Questionnaires revealed that 97.2 % of LESS-DN versus 79.5 % of LDN ( p = 0.03 ) were 100 % recovered by 2 months after donation . No significant difference was seen in satisfaction scores between the groups . Recipient outcomes were similar between groups . Our randomized trial comparing LESS donor nephrectomy to LDN confirms that LESS-DN offers a safe alternative to conventional LDN in terms of intra- and post-operative complications . LDN and LESS-DN offer similar recovery and satisfaction after donation .

laparoscopic

versus

laparoscopic donor nephrectomy ( LDN

LESS-DN

versus

LDN

LESS-DN

LDN

LESS-DN

LDN

LESS-DN

benefits

recovery/satisfaction questionnaires

Conversion to hand-assist laparoscopy

were 100 % recovered

seen in satisfaction

groups

Recipient outcomes

offers

similar recovery and satisfaction

nephrectomy for kidney donation .

One hundred

47 years

ischemia

blood loss


Intravenous flecainide versus verapamil for acute conversion of paroxysmal atrial fibrillation or flutter to sinus rhythm . In a single-blind randomized study , the efficacy of intravenous flecainide ( 2 mg/kg/10 minutes ) versus verapamil ( 10 mg/1 minute ) was assessed in 40 patients with paroxysmal atrial fibrillation ( AF ) or atrial flutter ( AFI ) . The treatment was considered successful if sinus rhythm occurred within 1 hour . Of 20 patients receiving flecainide , 14 of 17 ( 82 % ) with AF converted to sinus rhythm , but in 3 patients with AFI flecainide failed . All patients treated with verapamil ( 17 AF , 3 AFI ) showed lower ventricular rates after 1 hour ; however , only 1 ( 6 % ) with AF converted to sinus rhythm and 1 ( 6 % ) converted to AFI . Patients who did not convert to sinus rhythm after treatment with verapamil were treated with flecainide and observed for another hour . After the change to flecainide , 9 of 15 patients ( 60 % ) with AF still converted . Thus , 23 of 32 patients ( 72 % ) with AF and none of 7 with AFI converted to sinus rhythm after treatment with flecainide . Conversion to sinus rhythm was achieved in 19 of 22 patients ( 86 % ) when AF lasted less than 24 hours and in 4 of 10 ( 40 % ) when the arrhythmia lasted greater than 24 hours . Transient adverse effects were noted in 10 patients ( 26 % ) after flecainide . In summary , flecainide is an effective and safe drug for conversion of paroxysmal AF to sinus rhythm , but ineffective for AFI . Verapamil appears to be of no use for conversion of AF or AFI to sinus rhythm .

Intravenous flecainide

verapamil

intravenous flecainide

verapamil

flecainide

flecainide

verapamil

verapamil

flecainide

flecainide

Verapamil

efficacy

sinus rhythm

lower ventricular rates

converted .

Conversion to sinus rhythm

Transient adverse effects

effective and safe drug

conversion of AF or AFI

sinus rhythm

paroxysmal atrial fibrillation

sinus rhythm


Effect of selumetinib vs chemotherapy on progression-free survival in uveal melanoma : a randomized clinical trial . IMPORTANCE Uveal melanoma is characterized by mutations in GNAQ and GNA11 , resulting in mitogen-activated protein kinase pathway activation . OBJECTIVE To assess the efficacy of selumetinib , a selective , non-adenosine triphosphate competitive inhibitor of MEK1 and MEK2 , in uveal melanoma . DESIGN , SETTING , AND PARTICIPANTS Randomized , open-label , phase 2 clinical trial comparing selumetinib vs chemotherapy conducted from August 2010 through December 2013 among 120 patients with metastatic uveal melanoma at 15 academic oncology centers in the United States and Canada . INTERVENTIONS One hundred one patients were randomized in a 1:1 ratio to receive selumetinib , 75 mg orally twice daily on a continual basis ( n = 50 ) , or chemotherapy ( temozolomide , 150 mg/m2 orally daily for 5 of every 28 days , or dacarbazine , 1000 mg/m2 intravenously every 21 days [ investigator choice ] ; n = 51 ) until disease progression , death , intolerable adverse effects , or withdrawal of consent . After primary outcome analysis , 19 patients were registered and 18 treated with selumetinib without randomization to complete the planned 120-patient enrollment . Patients in the chemotherapy group could receive selumetinib at the time of radiographic progression . MAIN OUTCOMES AND MEASURES Progression-free survival , the primary end point , was assessed as of April 22 , 2013 . Additional end points , including overall survival , response rate , and safety/toxicity , were assessed as of December 31 , 2013 . RESULTS Median progression-free survival among patients randomized to chemotherapy was 7 weeks ( 95 % CI , 4.3-8.4 weeks ; median treatment duration , 8 weeks ; interquartile range [ IQR ] , 4.3-16 weeks ) and among those randomized to selumetinib was 15.9 weeks ( 95 % CI , 8.4-21.1 weeks ; median treatment duration , 16.1 weeks ; IQR , 8.1-25.3 weeks ) ( hazard ratio , 0.46 ; 95 % CI , 0.30-0.71 ; P < .001 ) . Median overall survival time was 9.1 months ( 95 % CI , 6.1-11.1 months ) with chemotherapy and 11.8 months ( 95 % CI , 9.8-15.7 months ) with selumetinib ( hazard ratio , 0.66 ; 95 % CI , 0.41-1.06 ; P = .09 ) . No objective responses were observed with chemotherapy . Forty-nine percent of patients treated with selumetinib achieved tumor regression , with 14 % achieving an objective radiographic response to therapy . Treatment-related adverse events were observed in 97 % of patients treated with selumetinib , with 37 % requiring at least 1 dose reduction . CONCLUSIONS AND RELEVANCE In this hypothesis-generating study of patients with advanced uveal melanoma , selumetinib compared with chemotherapy resulted in a modestly improved progression-free survival and response rate ; however , no improvement in overall survival was observed . Improvement in clinical outcomes was accompanied by a high rate of adverse events . TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT01143402 .

selumetinib

chemotherapy

selumetinib

selumetinib

chemotherapy

selumetinib

temozolomide

selumetinib

selumetinib

Progression-free survival

overall survival

uveal melanoma :

uveal melanoma

metastatic uveal melanoma


Electrothermal arthroscopic capsulorrhaphy : old technology , new evidence . A multicenter randomized clinical trial . BACKGROUND Radiofrequency technology for shoulder instability was rapidly adopted despite limited clinical evidence and a poor understanding of its indications . Reports of serious adverse events followed , leading to its abandonment . This paper presents findings from a multicenter randomized clinical trial evaluating the safety and efficacy of electrothermal arthroscopic capsulorrhaphy ( ETAC ) compared with open inferior capsular shift ( ICS ) and reviews the role of randomized trials in adopting new technology . METHODS Patients ( > 14 years ) diagnosed with multidirectional instability or multidirectional laxity with anteroinferior instability and failed nonoperative treatment were enrolled . Patients with bone lesions or labral , biceps anchor , or full-thickness rotator cuff tears were excluded intraoperatively . Outcomes included Western Ontario Shoulder Instability Index , function and recurrent instability at 2 years postoperatively , and surgical times . RESULTS Fifty-four subjects ( mean age , 23 years ; 37 women ) were randomized to ETAC ( n = 28 ) or open ICS ( n = 26 ) . The groups were comparable at baseline , except for external rotation at the side . At 2 years postoperatively , there were no statistically or clinically significant differences between groups for the Western Ontario Shoulder Instability Index ( P = .71 ) , American Shoulder and Elbow Surgeons score ( P = .43 ) , Constant score ( P = .43 ) , and active range of motion . Recurrent instability was not statistically different ( ETAC , 2 ; open , 4 ; P = .41 ) . ETAC ( 23 minutes ) was significantly shorter than open ICS ( 59 minutes ) ( P < .01 ) surgery . Three subjects ( 1 ETAC , 2 open ) had stiff shoulders . CONCLUSIONS At 2 years postoperatively , quality of life and functional outcomes between groups were not clinically different . ETAC had fewer complications and episodes of recurrence compared with open surgery . This evidence reinforces the need to critically evaluate new technology before widespread clinical use .

open inferior capsular shift ( ICS )

surgical times

external rotation at the

Western Ontario Shoulder Instability

American Shoulder and Elbow Surgeons

active range of motion . Recurrent

shoulder instability

Patients ( > 14 years )

multidirectional instability

Fifty-four

mean age , 23 years

women

n = 26


[ Mitomycin C plus HCFU adjuvant chemotherapy for noncuratively resected cases of colorectal carcinoma . ( Second report ) : 5-year survival rate . Cooperative Study Group of Kyushu and Chugoku for HCFU Adjuvant Chemotherapy ] . In order to examine the efficacy of adjuvant chemotherapy employing mitomycin C ( MMC ) and carmofur ( HCFU ) for patients with noncuratively resected colorectal carcinoma , a cooperative study was performed by 54 institutions in the Kyushu and Chugoku areas of Japan . The criteria for patient selection were as follows : 1 ) Age of 75 years or less and not accompanied by any serious disease . 2 ) Macroscopic diagnosis as being noncuratively resected on completion of the surgical procedure . 3 ) Definitive diagnosis of colorectal carcinomas , histologically . 4 ) No synchronous or metachronous double cancer . The prospective randomized controlled study consisted of two groups . In Group A , the MMC group received bolus intravenous injections of 20 mg MMC on the day of operation and 10 mg the next day , followed by 10 mg every 4 weeks until a total of 100 mg had been administered . In Group B , the MMC + HCFU group received the same treatment in Group A , but with the addition of 600 mg/day of HCFU from the second week , orally for at least one year . Concerning the 69-month survival rate , a better result was observed in the MMC + HCFU group than in the MMC only group ( generalized Wilcoxon test : p less than 0.05 ) . Significantly better survival rates were obtained in those cases with disseminating peritoneal metastasis , hepatic metastasis and stage V cancer in the MMC + HCFU group as when compared with the MMC only group . No significant side effects due to the combined administration of HCFU were recognized . The combined administration of MMC and HCFU was suggested to be a safe and effective adjuvant chemotherapy for noncuratively resected cases of colorectal carcinoma .

[ Mitomycin C plus HCFU

adjuvant chemotherapy

mitomycin C ( MMC )

carmofur ( HCFU )

MMC

MMC

MMC + HCFU group

HCFU

MMC + HCFU

MMC + HCFU

HCFU

MMC

HCFU

69-month survival rate

survival rates

significant side effects

Age of 75

colorectal carcinomas


Caregiver-mediated intervention for low-resourced preschoolers with autism : an RCT . OBJECTIVES To compare 2 short-term , community caregiver training interventions for preschool-aged children with Autism Spectrum Disorder who had low resources . Low resource was defined by the US Department of Housing and Urban Development low-income index or 1 " indicator , " ( e.g. , Medicaid eligibility ) . Child outcomes focused on joint engagement , joint attention , and play . METHODS Participants included 112 families of a child who had Autism Spectrum Disorder who met criteria for being low-resourced and who were randomly assigned to 1 of 2 3-month interventions , group caregiver education or individualized caregiver-mediated intervention ( CMM ) . Children were assessed for social communication skills pre- and post-treatment , and followed up at 3 months . RESULTS All children improved in joint engagement and initiating joint attention , with significantly greater improvement by the CMM group . Outcomes on play skills were mixed , with improvement of symbolic play for the CMM group and no change in functional play skills . Joint engagement maintained over time for the CMM group , and initiating joint attention maintained for both groups over time . CONCLUSIONS This study is among the first randomized trials comparing 2 active interventions with a large sample of low-resourced families . Results suggest improvements in core autism deficits of joint engagement , joint attention , and symbolic play with relatively brief , caregiver-mediated interventions , but additional support is necessary to maintain and generalize these gains over time .

intervention

2 3-month interventions

CMM

CMM

" indicator

engagement

pre- and post-treatment

joint engagement

initiating joint attention

play skills

symbolic play

functional play skills

joint attention

preschoolers

autism

preschool-aged children

Autism Spectrum Disorder

child

Autism Spectrum Disorder


Compared with the intake of commercial vegetable juice , the intake of fresh fruit and komatsuna ( Brassica rapa L. var . perviridis ) juice mixture reduces serum cholesterol in middle-aged men : a randomized controlled pilot study . BACKGROUND Vegetables and fruits are rich in vitamins , minerals and , dietary fiber and contribute to the prevention and improvement of obesity and metabolic syndrome . However , inadequate intake of vegetable and fruit is a concern in Japan.We therefore produced a juice mixture of fresh fruit and komatsuna ( Brassica rapa L. var . perviridis : B. rapa ) with the aim to investigate the effects of this juice mixture on anthropometric data , blood parameters , and dietary intake differences . METHODS This study was performed as a single blind and randomized controlled trial . Subjects were 16 men ( mean age , 46.4 ± 7.1 years ) , and they were divided into two groups ( control group and intervention group ) . The intervention group consumed the juice mixture of fresh fruit and B. rapa . The control group consumed commercial vegetable juice . Subjects consumed juice twice a day throughout the weekday , for 4 weeks . We prepared both juices with an equivalent energy balance . RESULTS Weight and body mass index ( BMI ) of the control group after 4 weeks were significantly increased compared with baseline values . Serum total cholesterol ( T-Chol ) and low-density lipoprotein cholesterol ( LDL-Chol ) of the intervention group after 4 weeks were significantly reduced compared with baseline values . Furthermore , intake of total vegetables and fruits were significantly increased compared with baseline values in both groups . CONCLUSIONS Both vegetable juices contributed to improved intake of total vegetables and fruit . Compared with the intake of commercial vegetable juice , the intake of fresh fruit and B. rapa juice is highly effective in reducing serum cholesterol . Short-term intake of fresh fruit and B. rapa juice was shown to enhance cholesterol metabolism .

commercial vegetable juice

var

perviridis )

fresh fruit and komatsuna

( Brassica rapa L. var

perviridis : B.

rapa

anthropometric data , blood parameters

RESULTS Weight and body mass index

values

Serum total cholesterol ( T-Chol )

intake of total vegetables and

improved intake of total vegetables and

effective in reducing serum cholesterol

enhance cholesterol metabolism

middle-aged

men

men

mean age , 46.4 ± 7.1 years


Self-management improvement program combined with community involvement in Thai hypertensive population : an action research . OBJECTIVE To investigate the effectiveness of a program that utilizes community involvement to improve the self-management strategies among people living with hypertension . MATERIAL AND METHOD Forty-four subjects , aged 35 to 59-year-old , with hypertension in Nakhon Pathom Province , Thailand , were randomly allocated to either an experimental group ( n = 22 ) or a control group ( n = 20 ) . The experimental group attended a program to improve self-management methods based on social cognitive theory ( SCT ) . The program lasted 12 weeks , consisted of 1 1/2 hours meeting once a week , including group meetings and home visit monitoring . Mann-Whitney U test and Friedman test were employed to analyze the program 's effectiveness . RESULTS After the program , the mean rank of the perceived self-efficacy for the self-management strategies was statistically different between the two groups ( p = 0.023 ) . In the experimental group , after the twelve week , the mean rank of perceived self-efficacy and outcome expectancy increased and diastolic blood pressure decreased after the eight week . CONCLUSION The program applied social cognitive theory ( SCT ) to promote self-management techniques , increased the health promoting behavior among hypertensive people .

self-management strategies

experimental

group

control group

group meetings

home visit monitoring

social cognitive theory ( SCT )

self-management techniques

effectiveness

U test

Friedman test

effectiveness

mean rank

perceived self-efficacy

self-management strategies

mean rank of perceived self-efficacy

outcome expectancy

diastolic blood pressure

health promoting behavior

Thai hypertensive

hypertension

Forty-four

35 to 59-year-old

hypertension

Nakhon Pathom Province , Thailand


Vitamin D supplementation ameliorates hypoinsulinemia and hyperglycemia in static magnetic field-exposed rat . The purpose of this study is to evaluate the effects of vitamin D supplementation on glucose and lipid metabolism in static magnetic field ( SMF ) -exposed rats . Rats exposed to SMF ( 128 mT ; 1 h/day ) during 5 consecutive days showed an increase in plasma glucose level and a decrease in plasma insulin concentration . By contrast , the same treatment failed to alter body weight and plasmatic total cholesterol , high-density lipoprotein ( HDL ) -cholesterol , low-density lipoprotein ( LDL ) -cholesterol , and triglyceride levels . Interestingly , supplementation with vitamin D ( 1,600 IU/100 g , per os ) corrected and restored glycemia and insulinemia in SMF-exposed rats . The same treatment had no effects on lipid metabolism .

Vitamin D supplementation

vitamin D supplementation

vitamin D

hypoinsulinemia and hyperglycemia

glucose and lipid metabolism

glycemia and insulinemia

lipid metabolism .

static magnetic field-exposed rat .

SMF-exposed rats


Standardized treatment of Chinese medicine decoction for cancer pain patients with opioid-induced constipation : a multi-center prospective randomized controlled study . OBJECTIVE To observe the efficacy and the influence on quality of life ( QOL ) of syndrome differentiation treatment with Chinese medicine ( CM ) for opioid-induced constipation as well as the safety and influence on analgesic effect of opioids . METHODS Totally 406 cases enrolled from 53 collaborating medical centers were randomly assigned to a CM group and a control group . The CM group were treated with CM decoction based on syndrome differentiation , and the control group were treated with Phenolphthalein Tablet . Both groups were treated for 14 days . Cleveland constipation score ( CCS ) , numerical rating scale ( NRS ) of pain and Chinese version of European Organisation for Research and Treatment of Cancer , Quality of Life Questionnaire-C30 V3.0 ( EORTC QLQ-C30 V3.0 ) were used to evaluate the efficacy , pain controlled and QOL status . RESULTS The comparisons of CCS score reduction and QOL between the two groups after treatment suggested that the improvements of constipation and QOL in the CM group were better than that in the control group ( P < 0.05 ) . The total efficiency of the CM group was better than the control group ( 93.5 % vs. 86.4 % , P < 0.05 ) . There was no significant difference in NRS scores between before and after treatment in both groups . There was no serious drug-related adverse event during the course of study . CONCLUSION CM decoction could effectively treat opioid-induced constipation and improve patients ' QOL at the same time . It is safe and does n't affect the analgesic effect of opioids when treating constipation .

Chinese medicine decoction

Chinese medicine ( CM )

CM

CM decoction

Phenolphthalein Tablet

CM decoction

opioid-induced constipation

406 cases

opioid-induced constipation


Riding the rapids : living with autism or disability -- an evaluation of a parenting support intervention for parents of disabled children . Evidence on the effectiveness of interventions to support parents of disabled children to manage their child 's behaviour problems is limited . The aim of this study was to evaluate a group-delivered intervention ( Riding the Rapids ) which was specifically developed for parents of a child with a disability or autistic spectrum condition . This programme has been routinely delivered by a community-based mental health team across an urban , multi-ethnic locality for a number of years . A non-randomised controlled study design comprising an intervention group ( n=48 ) and comparator ( no intervention ) group ( n=28 ) was used to evaluate the effects of the intervention on child behaviour ( Eyberg Child Behaviour Inventory ; parent-set goals ) and parenting efficacy and satisfaction ( Parents Sense of Competence Scale ) at post-intervention and six-month follow-up . Data on costs to the service provider of delivering the intervention were also collected . Receipt of the intervention was associated with significant reductions in parent-reported behaviour problems and significant improvements in parenting efficacy and satisfaction . At six-month follow-up , progress towards achieving parent-set child behaviour goals and parenting satisfaction had been maintained . Post hoc analysis suggests parents who do not have English as a first language may not benefit as much as other parents from this intervention . Findings suggest this is a promising intervention for parents of a child with a disability that is likely to be less resource intensive to service providers than individually delivered interventions . Limitations and implications for future research are discussed .

parenting support intervention

controlled

intervention group

comparator ( no intervention )

Eyberg Child Behaviour Inventory

intervention for parents

parenting efficacy and satisfaction

Parents Sense of Competence Scale

significant reductions

parent-reported behaviour problems

parent-set child behaviour goals

parenting satisfaction

not benefit

disabled children


Visual feedback and target size effects on reach-to-grasp tasks in children with autism . This study explores the effects of visual condition and target size during four reach-to-grasp tasks between autistic children and healthy controls . Twenty children with autism and 20 healthy controls participated in the study . Qualisys motion capture system and kinematic measures were used to record movement . Autistic group showed significantly longer movement time , larger normalized jerk score , more movement unit than controls , especially in non-visual feedback and small target blocks . Autistic group also showed significantly larger maximal grip aperture and normalized maximal grip aperture in visual feedback condition than controls . Autistic children demonstrate motor coordination problems and also depend on more visual cuing in high accuracy tasks . Autistic children develop other compensatory skills while performing tasks .

Visual feedback

target size effects

Qualisys motion capture system

kinematic measures

reach-to-grasp tasks

larger maximal grip aperture

normalized maximal grip aperture

motor coordination problems

visual cuing

compensatory skills

children

autism

autistic

children

healthy controls

Twenty

children

autism

Autistic

Autistic

Autistic

children

Autistic

children


The impact of the amount of social evaluation on psychobiological responses to a body image threat . The present study examined the impact of amount of social-evaluative body image threat on psychobiological responses . Women ( N=123 ) were randomized into an individual-threat , group-threat or no-threat condition . Participants completed a measure of state body shame and provided a sample of saliva ( to assess cortisol ) at baseline and following their condition . Both threat conditions had higher baseline-adjusted body shame following the threat compared to the no-threat condition ; however , no difference on baseline-adjusted body shame between the threat conditions was found . The same pattern of results was found for cortisol - both threat conditions had higher baseline-adjusted response cortisol than the no-threat condition , with no significant differences between the threat groups . Findings suggest that the magnitude of psychobiological responses to a social-evaluative body image threat does not differ with the amount of social-evaluative threat ( individual- versus group-threat ) . These findings provide insight into the context of body image threats of women .

social evaluation

state body shame

body image threat .

Women

women


Tacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched , related donor allogeneic HCT . Grades 2-4 acute graft-versus-host disease ( GVHD ) occurs in approximately 35 % of matched , related donor ( MRD ) allogeneic hematopoietic cell transplantation ( HCT ) recipients . We sought to determine if the combination of tacrolimus and sirolimus ( Tac/Sir ) was more effective than tacrolimus and methotrexate ( Tac/Mtx ) in preventing acute GVHD and early mortality after allogeneic MRD HCT in a phase 3 , multicenter trial . The primary end point of the trial was to compare 114-day grades 2-4 acute GVHD-free survival using an intention-to-treat analysis of 304 randomized subjects . There was no difference in the probability of day 114 grades 2-4 acute GVHD-free survival ( 67 % vs 62 % , P = .38 ) . Grades 2-4 GVHD was similar in the Tac/Sir and Tac/Mtx arms ( 26 % vs 34 % , P = .48 ) . Neutrophil and platelet engraftment were more rapid in the Tac/Sir arm ( 14 vs 16 days , P < .001 ; 16 vs 19 days , P = .03 ) . Oropharyngeal mucositis was less severe in the Tac/Sir arm ( peak Oral Mucositis Assessment Scale score 0.70 vs 0.96 , P < .001 ) , but otherwise toxicity was similar . Chronic GVHD , relapse-free survival , and overall survival at 2 years were no different between study arms ( 53 % vs 45 % , P = .06 ; 53 % vs 54 % , P = .77 ; and 59 % vs 63 % , P = .36 ) . Based on similar long-term outcomes , more rapid engraftment , and less oropharyngeal mucositis , the combination of Tac/Sir is an acceptable alternative to Tac/Mtx after MRD HCT . This study was funded by the National Heart , Lung , and Blood Institute and the National Cancer Institute ; and the trial was registered at www.clinicaltrials.gov as # NCT00406393 .

tacrolimus and sirolimus ( Tac/Sir )

tacrolimus and methotrexate ( Tac/Mtx )

Grades 2-4 GVHD

Neutrophil and platelet engraftment

Oropharyngeal mucositis

Oral Mucositis Assessment Scale score

toxicity

donor allogeneic HCT


The effects of two Chinese herbal medicinal formulae vs. placebo controls for treatment of allergic rhinitis : a randomised controlled trial . BACKGROUND Allergic rhinitis is a chronic illness , affecting 10 to 40 % of the worldwide population . Chinese herbal medicines , the treatment of allergic rhinitis , adopted thousands of years in ancient China , has recently raised much attention among researchers globally . This study evaluates the effects of two Chinese herbal formulae [ Cure-allergic-rhinitis Syrup ( CS ) and Yu-ping-feng San ( YS ) ] in treating undergraduate nursing students with allergic rhinitis over a 3-month follow-up , when compared to a placebo control group . METHODS A double-blind , randomised controlled trial with repeated-measures , three-parallel-groups design was conducted in a random sample of 249 participants recruited from one university in Hong Kong . After baseline measurements , participants were randomly assigned to CS , YS , or placebo groups ( n=83 per group ) . The main outcomes , including symptom severity , quality of life , and body constitution , were measured with self-administered questionnaires at baseline and immediately , 1 and 3 months after the 4-week interventions . RESULTS 240 participants completed the trial , with 9 ( 3.6 % ) drop-outs . The results of Generalised Estimating Equations test followed by pairwise contrasts tests indicated that the participants who received CS showed significantly greater reduction of symptoms ( mean difference of CS vs. placebo=26.13-34.55 , P < 0.0005 ) and improvements in quality of life ( mean difference of CS vs. placebo=12.81-16.76 , P < 0.001 ) , and body constitution in 'Qi-deficiency ' , 'Yang-deficiency ' , and 'Inherited Special ' ( mean difference of CS vs. placebo=7.05-8.12 , 7.56-8.92 , and 4.48-8.10 , P=0.01- < 0.0005 , 0.001-0.004 , and 0.01- < 0.0005 , accordingly , at three post-tests ) . The participants who received YS also indicated significant greater improvements in symptom severity , quality of life , and a few patterns of body constitution when compared to the placebo group . However , its effects were lesser in strength ( i.e. , smaller effect sizes ) , varieties of symptoms , and body constitution and sustainability over the 3 months . CONCLUSIONS The herbal formula CS was found effective to reduce symptoms and enhance quality of life in young adults ( nursing students ) with allergic rhinitis in 'Yang- and/or Qi-deficiency ' body constitution . Further controlled trials of its effects in Chinese and/or Asians with allergic rhinitis in terms of socio-demographic , ethnic and illness characteristics and a longer-term follow-up are recommended . TRIAL REGISTRATION The trial has registered at ClinicalTrials.gov with an ID : NCT02027194 ( 3 January 2014 ) .

Chinese herbal medicinal formulae

placebo

Yu-ping-feng San ( YS )

CS

YS

placebo

CS

symptom severity

quality of

body constitution

Generalised Estimating Equations test

reduction of symptoms

improvements in quality of life

symptom severity

quality of life

body constitution

symptoms

body constitution

symptoms

quality of life

allergic rhinitis :

Allergic rhinitis

allergic rhinitis


High-dose vitamin D3 supplementation in children and young adults with HIV : a randomized , placebo-controlled trial . BACKGROUND Suboptimal vitamin D status is prevalent in HIV-infected patients and associated with increased risk of disease severity and morbidity . We aimed to determine 12-month safety and efficacy of daily 7000 IU vitamin D3 ( vitD3 ) versus placebo to sustain increased serum 25-hydroxyvitamin D ( 25 ( OH ) D ) and improve immune status in HIV-infected subjects . METHODS This was a double-blind trial of perinatally acquired HIV ( PHIV ) -infected subjects or behaviorally acquired HIV ( BHIV ) -infected subjects ( 5.0-24.9 years ) . Safety , 25 ( OH ) D-related parameters and immune status were assessed at baseline , 3 , 6 and 12 months . RESULTS Fifty-eight subjects enrolled ( 67 % male , 85 % African American and 64 % BHIV ) and 50 completed with no safety concerns . In unadjusted analyses , there were no differences between randomization groups at baseline ; at 3 , 6 and 12 months , 25 ( OH ) D was higher with supplementation than baseline and higher than with placebo ( P < 0.05 ) . In adjusted mixed models , in the supplementation group , the fixed effect of 25 ( OH ) D was higher ( P < 0.001 ) . Percentage of naive T-helper cells ( Th naive % ) were significantly ( P < 0.01 ) and T-helper cells ( CD4 % ) marginally ( P < 0.10 ) increased with supplementation in those taking highly active antiretroviral therapy ( HAART ) , and RNA viral load was reduced ( P ≤ 0.05 ) . In exploratory linear models , change in 25 ( OH ) D predicted RNA viral load at 3 and 12 months and CD4 % at 3 months ( P < 0.05 ) . CONCLUSIONS Daily 7000 IU vitD3 for 12 months was safe in HIV-infected subjects and effective in increasing 25 ( OH ) D. Supplementation improved some clinically important HIV immune markers in subjects on HAART . Adjunct therapy with high-dose , daily vitD3 for HIV-infected subjects and for those on/off HAART requires further investigation .

vitamin D3 supplementation

placebo-controlled trial

7000 IU vitamin D3

placebo

HIV :

safety and efficacy

Safety

25 ( OH ) D-related parameters

immune status

safety concerns .

25 ( OH ) D

T-helper cells ( CD4 % )

RNA viral load

in 25 ( OH ) D predicted RNA viral load

and CD4 %

increasing 25 ( OH )

children and young adults

HIV

HIV-infected

HIV-infected subjects

5.0-24.9 years

Fifty-eight subjects enrolled

67 % male

85 % African American

64 %

50 completed with no safety concerns


Traumatic brain injury-related attention deficits : treatment outcomes with lisdexamfetamine dimesylate ( Vyvanse ) . BACKGROUND AND OBJECTIVES Attention deficits are often among the most persistent and debilitating impairments resulting from traumatic brain injury ( TBI ) . This study examined the effects of lisdexamfetamine dimesylate ( Vyvanse ) in treating attention deficits due to moderate-to-severe TBI . It was the first study of lisdexamfetamine dimesylate with this population and , in fact , was the first controlled trial in this area examining a stimulant medication option other than methylphenidate . METHODS This was a 12-week , randomized , double-blind , placebo-controlled , cross-over trial . A total of 22 rigorously selected cases were enrolled , 13 of whom completed the trial . They were 16-42 years of age and had newly acquired attention deficits persisting for 6-34 months post-injury . They were assessed on a broad range of neuropsychological and behavioural measures at baseline , 6-weeks and at 12-weeks . RESULTS AND CONCLUSIONS Positive treatment effects were found involving selective measures of sustained attention , working memory , response speed stability and endurance and in aspects of executive functioning . No major problems with safety or tolerability were observed . Some moderating treatment effects were found from a broad range of pre-treatment subject characteristics and injury variables examined . Avenues for further research and treatment applications in this area are discussed .

lisdexamfetamine dimesylate ( Vyvanse )

lisdexamfetamine dimesylate

methylphenidate .

placebo-controlled

attention deficits :

attention deficits

attention deficits

safety or tolerability

Traumatic brain injury-related

TBI

16-42 years of age

attention deficits


Comparison of clinical effectiveness of acupuncture and a Western drug on allergic rhinitis : study protocol for a randomized controlled trial . OBJECTIVE To compare the efficacy of an acupuncture regimen for persistent allergic rhinitis ( PER ) , aimed at improving a patient 's mind or Shen in Traditional Chinese Medicine , to that of a second-generation Hi-receptor antagonist , cetirizine hydrochloride . METHODS This multicenter , randomized , controlled clinical trial on PER will be conducted at three institutions in China . The total study period will be 9 weeks . After a 1-week preparatory screening period , 240 eligible participants with PER will be randomized to receive acupuncture or pharmacotherapy ( 1:1 ) for 4 weeks with a 4-week follow-up . The primary outcome will be changes in 7-day average total nasal symptom score . Secondary outcome measures include rhinoconjunctivitis quality of life questionnaire score and total non-nasal symptom score . RESULTS The presence and seriousness of psychological and emotional impairments should be considered in therapeutic programs for allergic rhinitis . No clinical trial for treating allergic rhinitis via acupuncture regulation of psychological and emotional activities has been reported . CONCLUSION The findings of the trial will allow us to determine the effects of the mind ( Shen ) -regulation treatment approach . We will also be able to confirm if the effects of acupuncture are equivalent to those of the conventional drug cetirizine hydrochloride .

acupuncture

Western drug

acupuncture regimen

Traditional Chinese Medicine

acupuncture

pharmacotherapy

acupuncture

cetirizine hydrochloride .

clinical effectiveness

7-day average total nasal symptom score

and

total non-nasal symptom score

allergic rhinitis :

persistent allergic rhinitis ( PER )


Quality of life and fatigue of patients with spinal bone metastases under combined treatment with resistance training and radiation therapy- a randomized pilot trial . BACKGROUND The aim of this trial was to compare the effects of resistance training versus passive physical therapy on quality of life ( QoL ) , fatigue , and emotional distress outcomes during radiation therapy in patients with spinal bone metastases under radiotherapy ( RT ) . METHODS In this randomized trial , 60 patients were treated from September 2011 until March 2013 into one of the two groups : isometric resistance training or physical therapy with thirty patients in each group during RT . EORTC QLQ-BM22 , EORTC QLQ-FA13 , and FBK-R10 were assessed at baseline , three months , and six months after RT . RESULTS Psychosocial aspects in resistance training group ( Arm A ) were significantly improved after three ( p = 0.001 ) and six months ( p = 0.010 ) . Other rated items of the QLQ-BM22 painful site , and pain characteristics were without significant differences . Functional interference showed a positive trend after six months ( p = 0.081 ) . After six months , physical fatigue ( p = 0.013 ) , and interference with daily life ( p = 0.006 ) according to the QLQ-FA13 assessment improved in Arm A significantly . Emotional distress was in Arm A lower after six months ( p = 0.016 ) . The Cohen 's effect size confirmed the clinically significant improvement of these findings . CONCLUSIONS In this group of patients we were able to show that guided isometric resistance training of the paravertebral muscles can improve functional capacity , reduce fatigue and thereby enhance QoL over a 6-months period in patients with stable spinal metastases . The results offer a rationale for future large controlled investigations to confirm these findings . TRIAL REGISTRATION Clinical trial identifier NCT01409720 .

resistance training

radiation therapy-

radiotherapy ( RT ) .

isometric resistance training

physical therapy

RT

RT

resistance training

Quality of life and

fatigue

quality of life ( QoL ) ,

fatigue , and emotional distress

EORTC QLQ-BM22 , EORTC QLQ-FA13

physical

interference

functional capacity

fatigue

spinal bone metastases

radiation therapy-


Neck circumference and early stage atherosclerosis : the cardiometabolic risk in Chinese ( CRC ) study . BACKGROUND Neck circumference ( NC ) has been previously related to cardiometabolic risk factors . In this study we examined the association between NC and early stage atherosclerosis in Chinese adults . METHODS The study samples were from a community-based health examination survey in central China . In total 2,318 men and women ( 18-64 y ) were included in the final analyses . Carotid radial pulse wave velocity ( crPWV ) , carotid femoral PWV ( cfPWV ) , carotid artery dorsalis pedis PWV ( cdPWV ) and NC were measured . RESULTS After adjustment for age , sex , lipids , glucose , blood pressure , heart rate , body mass index ( BMI ) , high NC was significantly associated with an increasing trend of cfPWV , cdPWV and crPWV ( P = 0.001 , 0.049 , and 0.038 ; respectively ) . In addition , we found significant interaction between hypertension status and NC level in relation to cfPWV , adjusted for age , sex , BMI , fasting glucose , lipids and heart rate ( P for interaction = 0.034 ) . The associations between NC and cfPWV were significant ( P = 0.02 ) among those with hypertension , but not significant among those without hypertension . CONCLUSIONS Our data showed that high NC was associated with an increased risk of early stage atherosclerosis in Chinese adults , independent of other metabolic risk factors . Hypertension might modify the association between NC and cfPWV .

Neck circumference

carotid femoral PWV ( cfPWV )

NC

cfPWV

cdPWV

crPWV

hypertension status

NC level

early stage atherosclerosis

early stage atherosclerosis

adults .

men

women

18-64 y

early stage atherosclerosis

Chinese


A further investigation of goal-directed intention understanding in young children with autism spectrum disorders . Findings from research investigating goal-directed intention understanding in children with autism spectrum disorders ( ASD ) have been equivocal , in part because of the varying methodologies used across studies . This study compares both object-oriented and social-communicatively cued goal-directed intention understanding in children with ASD and typically-developing children . Relative to matched controls , children with ASD did not exhibit deficits in object-oriented intention understanding . While children with ASD also demonstrated the ability to understand intention when cued by social-communication indicators , typically-developing children differentiated between intentional and unintentional acts at a significantly greater level . Group differences in performance were eliminated if only trials in which children attended to the experimenter 's face were considered . Results suggest that children with ASD have intact object-oriented intention understanding abilities , and are able to use social-communicative cues to understand intention . However , their ability to demonstrate social-communicatively cued intention understanding is limited by a lack of attention to relevant social-communicative information .

goal-directed intention understanding

goal-directed intention

understanding

understanding

object-oriented intention

understanding

social-communicatively cued intention

understanding

goal-directed intention understanding

goal-directed intention understanding

object-oriented intention understanding

object-oriented intention understanding

social-communicatively cued intention

young children

autism spectrum disorders .

children

autism spectrum disorders ( ASD

children

ASD

children

children

ASD

children

ASD


Autism Spectrum Social Stories In Schools Trial ( ASSSIST ) : study protocol for a feasibility randomised controlled trial analysing clinical and cost-effectiveness of Social Stories in mainstream schools . INTRODUCTION Current evidence suggests that Social Stories can be effective in tackling problem behaviours exhibited by children with autism spectrum disorder . Exploring the meaning of behaviour from a child 's perspective allows stories to provide social information that is tailored to their needs . Case reports in children with autism have suggested that these stories can lead to a number of benefits including improvements in social interactions and choice making in educational settings . METHODS AND ANALYSIS The feasibility of clinical and cost-effectiveness of a Social Stories toolkit will be assessed using a randomised control framework . Participants ( n=50 ) will be randomised to either the Social Stories intervention or a comparator group where they will be read standard stories for an equivalent amount of time . Statistics will be calculated for recruitment rates , follow-up rates and attrition . Economic analysis will determine appropriate measures of generic health and resource use categories for cost-effectiveness analysis . Qualitative analysis will ascertain information on perceptions about the feasibility and acceptability of the intervention . ETHICS AND DISSEMINATION National Health Service Ethics Approval ( NHS ; ref 11/YH/0340 ) for the trial protocol has been obtained along with NHS Research and Development permission from Leeds and York Partnership NHS Foundation Trust . All adverse events will be closely monitored , documented and reported to the study Data Monitoring Ethics Committee . At least one article in a peer reviewed journal will be published and research findings presented at relevant conferences . TRIAL REGISTRATION NUMBER ISRCTN96286707 .

Social Stories

Social Stories

Social Stories

autism spectrum disorder

children

autism


The effect of resistance training during radiotherapy on spinal bone metastases in cancer patients - a randomized trial . PURPOSE To compare the effects of resistance training versus passive physical therapy on bone density in the metastatic bone during radiation therapy ( RT ) as combined treatment in patients with spinal bone metastases . Secondly , to quantify pathological fractures after combined treatment . MATERIAL AND METHODS In this randomized trial , 60 patients were allocated from September 2011 until March 2013 into one of the two groups : resistance training ( group A ) or passive physical therapy ( group B ) with thirty patients in each group during RT . Bone density in metastatic and non-metastatic vertebral bone was assessed at baseline , 3 and 6 months after RT . RESULTS Bone density in all metastases increased significantly by 28.3 % ( IQR 11.4-139.0 ) and 80.3 % ( IQR 32.6-250.6 ) after 3 and 6 months in group A ( both p < 0.01 ) . The bone density in group A was significantly increased compared to control group after 3 and 6months ( both p < 0.01 , median 59.7 ; IQR 21.1-98.3 and median 62.9 ; IQR -9.7 to 161.7 ) . The bone density data in group B showed no significant increase over the course of time ( p = 0.289 , median 5.5 , IQR 0.0-62.2 and p = 0.057 , median 52.1 , IQR 0.0-162.7 ) . 23.3 % of the patients in group A and 30.0 % of the patients in group B had pathological fractures , no fracture was assigned to intervention , and no difference between groups after 3 and 6 months was observed ( p = 0.592 and p = 0.604 ) . CONCLUSIONS Our trial demonstrated that resistance training concomitant to RT can improve bone density in spinal bone metastases . This combined treatment is effective , practicable , and without side effects for patients . Importantly , the pathological fracture rate in the intervention group was not increased . The results offer a rationale for future large controlled investigations to confirm these findings . TRIAL REGISTRATION Clinical trial identifier NCT01409720 .

resistance training

during

radiotherapy

resistance training

passive physical therapy

radiation therapy ( RT )

resistance training

passive physical therapy

control

resistance training

concomitant to RT

spinal bone metastases

bone density in the metastatic bone

Bone density in all metastases

bone density

bone density data

pathological fractures

bone density

side effects

pathological fracture rate

patients with spinal bone metastases

60 patients


TEN versus TPN following major abdominal trauma -- reduced septic morbidity . Recent animal models suggest that enteral feeding ( TEN ) compared to parenteral nutrition ( TPN ) improves resistance to infection . This prospective clinical trial examined the impact of early TEN vs. TPN in the critically injured . Seventy-five patients with an abdominal trauma index ( ATI ) greater than 15 and less than 40 were randomized at initial laparotomy to receive either TEN ( Vivonex TEN ) or TPN ( Freamine HBC 6.9 % and Trophamine 6 % ) ; both regimens contained 2.5 % fat , 33 % branched chain amino acids , and had a calorie to nitrogen ratio of 150:1 . TEN was delivered via a needle catheter jejunostomy . Nutritional support was initiated within 12 hours postoperatively in both groups , and infused at a rate sufficient to render the patients in positive nitrogen balance . The study groups ( TEN = 29 vs TPN = 30 ) were comparable in age , injury severity and initial metabolic stress . Jejunal feeding was tolerated unconditionally in 25 ( 86 % ) of the TEN group . Nitrogen balance remained equivalent throughout the study period , at day 5 TEN = -0.3 +/- 1.0 vs. TPN 0.1 +/- 0.8 gm/day . Traditional nutritional protein markers ( albumin , transferrin , and retinol binding protein ) were restored better in the TEN group . Infections developed in 5 ( 17 % ) of the TEN patients compared to 11 ( 37 % ) of the TPN group . The incidence of major septic morbidity was 3 % ( 1 = abdominal abscess ) in the TEN group contrasted to 20 % ( 2 = abdominal abscess , 6 = pneumonia ) with TPN . This clinical study demonstrates that TEN is well tolerated in the severely injured , and that early feeding via the gut reduces septic complications in the stressed patient .

TEN

TPN

enteral feeding ( TEN )

parenteral nutrition ( TPN )

TEN

TPN

initial laparotomy

TEN

TPN

TEN

TEN

TPN

TEN

TEN

TPN

TEN

TEN

TPN

TEN

TPN

TEN

tolerated

Nitrogen balance

Infections

major septic morbidity

major abdominal trauma

septic morbidity

critically injured

Seventy-five

abdominal trauma

laparotomy

severely injured


Safety assessment of docosahexaenoic acid in X-linked retinitis pigmentosa : the 4-year DHAX trial . PURPOSE Docosahexaenoic acid ( DHA ) continues to be evaluated and recommended as treatment and prophylaxis for various diseases . We recently assessed efficacy of high-dose DHA supplementation to slow vision loss in patients with X-linked retinitis pigmentosa ( XLRP ) in a randomized clinical trial . Because DHA is a highly unsaturated fatty acid , it could serve as a target for free-radical induced oxidation , resulting in increased oxidative stress . Biosafety was monitored during the 4-year trial to determine whether DHA supplementation was associated with identifiable risks . METHODS Males ( n = 78 ; 7-31 years ) meeting entry criteria were enrolled . The modified intent-to-treat cohort ( DHA = 33 ; placebo = 27 ) adhered to the protocol ≥ 1 year . Participants were randomized to an oral dose of 30 mg/kg/d DHA or placebo plus a daily multivitamin . Comprehensive metabolic analyses were assessed for group differences . Treatment-emergent adverse events including blood chemistry metabolites were recorded . RESULTS By year 4 , supplementation elevated plasma and red blood cell-DHA 4.4- and 3.6-fold , respectively , compared with the placebo group ( P < 0.00001 ) . Over the trial duration , no significant differences between DHA and placebo groups were found for vitamin A , vitamin E , platelet aggregation , antioxidant activity , lipoprotein cholesterol , or oxidized LDL levels ( all P > 0.14 ) . Adverse events were transient and not considered severe ( e.g. , gastrointestinal [ GI ] irritability , blood chemistry alterations ) . One participant was unable to tolerate persistent GI discomfort . CONCLUSIONS Long-term , high-dose DHA supplementation to patients with XLRP was associated with limited safety risks in this 4-year trial . Nevertheless , GI symptoms should be monitored in all patients taking high dose DHA especially those with personal or family history of GI disturbances . ( ClinicalTrials.gov number , NCT00100230 . ) .

docosahexaenoic acid

placebo

vision loss

Biosafety

X-linked retinitis pigmentosa :


Comparison of postoperative short-term complications after laparoscopic transabdominal preperitoneal ( TAPP ) versus Lichtenstein tension free inguinal hernia repair : a randomized trial study . AIM The aim of this randomized trial was to compare short-term postoperative complications of laparoscopic transabdominal preperitoneal ( TAPP ) and Lichtenstein tension free hernia repair . METHODS A total of 120 patients who went inguinal hernia repair at Shahid Sadoughi university training hospital from April 2011 to August 2013 were randomized into two TAPP ( N.=60 ) and Lichtenstein ( N.=60 ) repair group . Follow-up occurred within 6 weeks . The postoperative assessments included pain score ( VAS ) , hematoma/seroma , urinary retention , wound infection incidence , and duration of hospital stay . RESULTS Pain was the most common symptoms in both groups . The TAPP group patients significantly had experienced less postoperative pain than the Lichtenstein group in all moments ( P < 0.05 ) . TAPP group had lower incidence of hematoma ( TAPP , 6.6 % vs. Lichtenstein 13.3 % ; P=0.67 ) , seroma ( TAPP 10 % vs. Lichtenstein 13.3 % ; P=1.00 ) , and infection ( TAPP 0 vs. Lichtenstein 1.6 % ; P=0.67 ) . However , no differences between the 2 groups were found in terms of postoperative complications . In TAPP group mean of hospital stay significantly was less than Lichtenstein group ( TAPP , 8.13±2.19 vs. Lichtenstein , 13.15±1.5 days ; P < 0.001 ) . CONCLUSION The laparoscopic TAPP repair is safer and less complicated approach to inguinal hernia repair . The two main short-term advantages of the laparoscopic TAPP repair with the tension free Lichtenstein repair were less postoperative pain and earlier return to the normal life activities . No difference was seen in overall complications .

inguinal hernia repair

TAPP

Lichtenstein

Lichtenstein

Lichtenstein

Lichtenstein

Lichtenstein

Lichtenstein

pain score ( VAS )

hematoma/seroma

urinary retention

wound infection incidence

duration of hospital stay

Pain

postoperative pain

hematoma

seroma

infection

postoperative complications

mean of hospital stay

inguinal hernia repair


Evidence for diminished multisensory integration in autism spectrum disorders . Individuals with autism spectrum disorders ( ASD ) exhibit alterations in sensory processing , including changes in the integration of information across the different sensory modalities . In the current study , we used the sound-induced flash illusion to assess multisensory integration in children with ASD and typically-developing ( TD ) controls . Thirty-one children with ASD and 31 age and IQ matched TD children ( average age = 12 years ) were presented with simple visual ( i.e. , flash ) and auditory ( i.e. , beep ) stimuli of varying number . In illusory conditions , a single flash was presented with 2-4 beeps . In TD children , these conditions generally result in the perception of multiple flashes , implying a perceptual fusion across vision and audition . In the present study , children with ASD were significantly less likely to perceive the illusion relative to TD controls , suggesting that multisensory integration and cross-modal binding may be weaker in some children with ASD . These results are discussed in the context of previous findings for multisensory integration in ASD and future directions for research .

sound-induced flash illusion

multisensory integration

multisensory integration

children

ASD

typically-developing ( TD ) controls

Thirty-one

ASD

( average age = 12 years

ASD


Weighted blankets and sleep in autistic children -- a randomized controlled trial . OBJECTIVE To assess the effectiveness of a weighted-blanket intervention in treating severe sleep problems in children with autism spectrum disorder ( ASD ) . METHODS This phase III trial was a randomized , placebo-controlled crossover design . Participants were aged between 5 years and 16 years 10 months , with a confirmed ASD diagnosis and severe sleep problems , refractory to community-based interventions . The interventions were either a commercially available weighted blanket or otherwise identical usual weight blanket ( control ) , introduced at bedtime ; each was used for a 2-week period before crossover to the other blanket . Primary outcome was total sleep time ( TST ) recorded by actigraphy over each 2-week period . Secondary outcomes included actigraphically recorded sleep-onset latency , sleep efficiency , assessments of child behavior , family functioning , and adverse events . Sleep was also measured by using parent-report diaries . RESULTS Seventy-three children were randomized and analysis conducted on 67 children who completed the study . Using objective measures , the weighted blanket , compared with the control blanket , did not increase TST as measured by actigraphy and adjusted for baseline TST . There were no group differences in any other objective or subjective measure of sleep , including behavioral outcomes . On subjective preference measures , parents and children favored the weighted blanket . CONCLUSIONS The use of a weighted blanket did not help children with ASD sleep for a longer period of time , fall asleep significantly faster , or wake less often . However , the weighted blanket was favored by children and parents , and blankets were well tolerated over this period .

Weighted blankets

weighted-blanket intervention

weighted blanket

control blanket

weighted blanket

weighted blanket

weighted blanket

total sleep time

( TST )

sleep efficiency

assessments of child behavior

family functioning

adverse events

TST

well tolerated

autistic children -- a