A controlled comparison between single doses of intravenous and intramuscular morphine with respect to analgesic effects and patient safety . UNLABELLED BACKGROUND AND AIM OF INVESTIGATION : Intramuscular ( IM ) administration has been considered to be safer than intravenous ( IV ) for opioids on wards , but a comparative knowledge of patient safety and analgesic potency following a single dose of IV and IM administration is lacking . This study was carried out to compare patient safety and analgesic efficacy of a single and high dose of morphine given IM or IV for post-operative pain management . MATERIALS AND METHODS Thirty-eight patients with post-operative pain following hip replacement surgery were given IM or IV morphine 10 mg at a specified pain level . The study was randomized and double blinded . Time to onset of analgesic effect ( 11-point numeric rating scale ) , respiratory function ( p ( a ) CO2 , p ( a ) O2 , and respiratory rate ) , level of sedation ( 5-point verbal rating scale ) , and hemodynamic function were recorded . RESULTS In the IV group there was a slight but significant increase in p ( a ) CO2 after 5 , 10 , and 15 min compared with the IM group ( 5.2 vs. 4.8 , 5.4 , vs. 5.0 and 5.5 vs. 5.1 kPa , respectively ) . The IV group had a significantly faster onset of analgesic effect than the IM group ( 5 vs. 20 min ) . Between 5 and 25 min after morphine administration , pain status in the IV group was significantly improved compared with the IM group . Patients in the IV group were slightly more sedated than the IM group 5 and 10 min after morphine . CONCLUSION A 10 mg bolus dose of IV morphine given to patients with moderate pain after surgery does not cause severe respiratory depression , but provides more rapid and better initial analgesia than 10 mg given IM . IV morphine even at a dose as high as 10 mg IV is well tolerated if there is a certain level of pain at its administration . The safety of IV morphine on the general ward needs to be further explored in adequately controlled studies .

intravenous and intramuscular morphine

opioids

morphine given IM or IV

hip replacement surgery

IM or IV morphine

morphine

surgery

morphine

morphine

analgesic effects

patient safety .

patient safety

analgesic potency

patient safety and analgesic efficacy

onset of analgesic effect

pain status

sedated

severe respiratory depression

initial analgesia

tolerated


Social stories : mechanisms of effectiveness in increasing game play skills in children diagnosed with autism spectrum disorder using a pretest posttest repeated measures randomized control group design . An increasing body of literature has indicated that social stories are an effective way to teach individuals diagnosed with autism appropriate social behavior . This study compared two formats of a social story targeting the improvement of social skills during game play using a pretest posttest repeated measures randomized control group design . A total of 45 children diagnosed with Autism Spectrum Disorder ( ASD ) ages 7-14 were randomly assigned to standard , directive , or control story conditions . Results demonstrated that the standard and directive story formats were equally as effective in eliciting , generalizing and maintaining the targeted social skills in participants who had prior game play experience and Verbal Comprehension Index ( VCI ) scores from the WISC-IV intelligence test in the borderline range or above .

game play skills

improvement of social skills

eliciting , generalizing and

maintaining the targeted social skills

children

diagnosed with autism spectrum disorder

autism

children

Autism Spectrum Disorder ( ASD )


Association of chronic kidney disease with outcomes in chronic heart failure : a propensity-matched study . BACKGROUND Chronic kidney disease ( CKD ) is associated with increased mortality in patients with heart failure ( HF ) . However , its association with hospitalization in HF patients has not been well studied . METHODS Of 7788 patients in the Digitalis Investigation Group trial , 3527 had CKD , defined by an estimated glomerular filtration rate ( GFR ) < 60 ml/min/1.73 m ( 2 ) body surface area ( BSA ) . Propensity scores for CKD were calculated using a multivariable logistic regression model and used to match 2399 pairs of patients with and without CKD . Matched Cox regression analyses were used to estimate association of CKD with outcomes . RESULTS All-cause hospitalization occurred in 1636 ( rate , 4233/10,000 person-years ) and 1587 ( rate , 3733/10,000 person-years ) patients respectively , with and without CKD ( matched hazard ratio [ HR ] for CKD , 1.18 , 95 % confidence interval [ CI ] , 1.08-1.29 ; P < 0.0001 ) . Matched HR for cardiovascular and HF hospitalization were respectively 1.17 ( 95 % CI , 1.06-1.28 , P = 0.002 ) and 1.28 ( 95 % CI , 1.13-1.45 , P < 0.0001 ) . Compared to GFR > or=60 ml/min/1.73 m ( 2 ) BSA , HR for all-cause hospitalization for GFR 45-59 and < 45 ml/min/1.73 m ( 2 ) BSA were respectively 1.04 ( 95 % CI , 0.94-1.16 ; P = 0.422 ) and 1.58 ( 95 % CI , 1.34-1.87 ; P < 0.0001 ) . Similarly , HR for all-cause death for GFR 45-59 and < 45 ml/min/1.73 m ( 2 ) BSA were respectively 1.03 ( 95 % CI , 0.90-1.18 ; P = 0.651 ) and 1.70 ( 95 % CI , 1.40-2.07 ; P < 0.0001 ) . Matched HR for death due to cardiovascular causes and progressive HF were respectively 1.24 ( 95 % CI , 1.09-1.40 ; P = 0.001 ) and 1.42 ( 95 % CI , 1.16-1.72 ; P = 0.001 ) . CONCLUSION CKD was associated with increased mortality and hospitalization in ambulatory patients with chronic HF , which increased progressively with worsening kidney function .

multivariable logistic regression model

Matched Cox regression analyses

chronic heart failure

mortality

All-cause hospitalization

mortality

kidney function .

chronic kidney disease

chronic heart failure

heart failure

HF

HF

CKD

ambulatory

chronic HF


Concurrent training enhances athletes ' cardiovascular and cardiorespiratory measures . We evaluated the effects of concurrent strength and aerobic endurance training on cardiovascular and cardiorespiratory adaptations in college athletes and compared two concurrent exercise ( CE ) protocols . Separate experiments were performed on 30 women ( mean age 19.6 years ) and 20 men ( 20.4 years ) . In both experiments , subjects were divided into two groups ( serial CE and integrated CE ) matched for initial physical condition and trained in a vigorous 3-day per week CE program of 9 ( men ) to 11 ( women ) weeks . The two CE training protocols were equilibrated for exercise mode , intensity , and volume , differing only in the timing and sequence of exercises . During training , serial CE discernibly ( p < 0.05 ) increased cardiovascular adaptation in women , indicated by reduction ( -5.7 % ) in active heart rate ( HR ) ( HR/aerobic exercise intensity ) , whereas integrated CE discernibly reduced active HR in women ( -10.7 % ) and men ( -9.1 % ) . Before and after comparisons in the larger sample of women showed that serial CE discernibly reduced systolic and diastolic blood pressure ( BP ) ( -8.7 % and -14.0 % , respectively ) , increased estimated [ latin capital V with dot above ] o2max ( 18.9 % ) , and produced a trend ( 0.10 > p > 0.05 ) toward reduced resting HR ( -4.9 % ) . Integrated CE in women discernibly reduced systolic and diastolic BP ( -13.2 % and -12.6 % , respectively ) , increased estimated [ latin capital V with dot above ] o2max ( 22.9 % ) , and produced a trend toward reduced resting HR ( -2.4 % ) . Integrated CE produced discernibly larger gains than serial CE or a trend for four of six training adaptations . Effect sizes were generally large ( 60.0 % of discernible differences ) . We conclude that , for cardiovascular and cardiorespiratory adaptations in athletes , strength and endurance training are compatible and that exercise timing and sequence significantly influence training adaptations , complimenting our previous similar conclusions for strength , muscle endurance , body composition , and flexibility .

training

strength

aerobic

concurrent exercise ( CE )

serial CE

integrated CE

CE program

CE training

Integrated CE

Integrated CE

active heart rate

active HR

systolic and diastolic blood pressure

above ] o2max

resting HR

systolic and diastolic BP

resting HR

women

men


Behavior in children with Down syndrome . OBJECTIVE To highlight the differences in behaviors in children with diagnosis of Down syndrome . METHOD Eight children with Down syndrome who displayed autistic features were compared with eight Down syndrome children without autistic features . These children were randomly selected and were matched for age and level of retardation . Standardized Psychological tests were administered to tap the behavioral differences . Mann-Whitney U test was used for significance of difference between both the groups . RESULTS Down syndrome children without Autism Spectrum Disorder had better communication and socialization skills than children with Down syndrome with Autism Spectrum Disorder . Down syndrome children with Autism Spectrum Disorder displayed more restricted repetitive and stereotyped patterns of behaviors , interests and activities . CONCLUSION Our findings indicate that Autism Spectrum Disorder manifests as a distinct behavioral phenomenon in Down syndrome . Hence it is important for professionals to consider the possibility of a dual diagnosis which will entitle the child to a more specialized and effective educational and intervention services .

Standardized Psychological tests

Mann-Whitney U test

Mann-Whitney U test

communication and socialization skills

behavioral phenomenon

Down syndrome

Eight

children

Down syndrome

autistic

eight

Down syndrome children


A prospective study on the clinical performance of polysiloxane soft liners : one-year results . OBJECTIVE The aim of the present study was to evaluate the clinical performance of four denture soft liners up to 12 months . MATERIALS AND METHODS Thirty-three edentulous patients who experienced difficulties when using hard denture bases because of changes in denture-supporting tissues were accepted for the study and randomly received Molloplast B , GC Reline Soft , Silagum Comfort , or Mollosil Plus relines . Performance of the materials was evaluated using nine criteria at 3 , 6 , and 12 months : physical integrity , surface detail , adhesion , color , odor , plaque accumulation , resilience , hygiene , and mucosal condition . A four-point categorized scale ( 1=poor , 2=fair , 3=good , 4=excellent ) was used . Unscheduled maintenance events and the presence of fungal colonization were also recorded . RESULTS The percentage of patients available at 3 , 6 , and 12 months were 91 % , 91 % , and 66 % . Main reasons for dropouts and discontinuation were fractured dentures and patient dissatisfaction . At 6 months , 96 % of the performance scores were good or excellent and the largest changes were observed for physical integrity , surface detail , color , and fungal colonization . Fungal colonization was the most commonly observed problem and was the only reason of failure at 12 months . CONCLUSIONS The clinical performance of all soft liners was slightly impaired over the 12-month observation . Except for cases showing extensive fungal colonization , the observed changes in clinical performance did not necessitate remaking of the dentures . Mollosil Plus showed a performance comparable to that of Molloplast B , and the other materials had slightly lower performance especially in terms of fungal colonization .

polysiloxane soft liners

denture soft liners

Mollosil Plus

Molloplast B

Unscheduled maintenance events

presence of fungal colonization

fractured dentures

patient dissatisfaction

performance scores

fungal colonization

Fungal colonization

fungal colonization

fungal colonization


Efficacy of latanoprost when stored at room temperature . We compared the ocular hypotensive effect for 24 hours and the tolerability of latanoprost stored at 4 degrees C and 30 degrees C. Seventeen healthy volunteers were included in this crossover trial . Latanoprost 0.005 % ( Xalatan ) was stored at 4 degrees C or 30 degrees C for 4 weeks in the dark . The subjects enrolled to the study were randomly assigned to receive either latanoprost stored at 4 degrees C or that stored at 30 degrees C. The eye drop was applied to the right eye of each subject for 3 days . The left eye served as a control without administration . Slit-lamp biomicroscopy and circadian intra ocular pressure ( IOP ) curve was performed at Day 3 , every 3 hours from 6 pm . This procedure was repeated 7 days after changing the drug from 4 degrees C to 30 degrees C or vice versa , and application to the left eye for 3 days . Eyes treated with latanoprost , stored both at 4 degrees C and 30 degrees C , achieved statistically significantly lower mean IOPs than untreated eyes at all time points , except at 21 hours treated by the drug stored at 30 degrees C. We subtracted the IOP of eyes receiving latanoprost from the IOP of untreated eyes for each time point to evaluate the efficacy of the eye drops ( delta IOP ) . There were no statistically significant differences between the delta IOPs with the drug stored at 4 degrees C and 30 degrees C. During the study , no subject developed a serious adverse event . These results suggest that latanoprost stored at 30 degrees C for 4 weeks after opening the bottle remains as effective and safe as latanoprost stored under cold conditions .

latanoprost

latanoprost

Latanoprost

Xalatan

latanoprost

Slit-lamp biomicroscopy

Efficacy

effect

efficacy

Seventeen healthy volunteers


Long-term follow-up of a phase I/II randomized , placebo-controlled trial of palifermin to prevent graft-versus-host disease ( GVHD ) after related donor allogeneic hematopoietic cell transplantation ( HCT ) . We previously conducted a randomized , double-blind , placebo-controlled study conducted from 2000 to 2003 of palifermin , a recombinant human keratinocyte growth factor , dosed from 240 microg/kg to 720 microg/kg , in 100 allogeneic hematopoietic stem cell transplantation ( HCT ) recipients . Treatment with palifermin showed beneficial effects on mucositis , but no significant effect on engraftment , acute graft-versus-host disease ( GVHD ) , or early survival . In addition to the effect of palifermin on mucosa , other pleotrophic effects , including more rapid immune reconstitution , have been seen in experimental transplant models . Therefore , we investigated whether with longer follow-up we could detect additional differences between the palifermin-treated and placebo cohorts . We found no differences in CMV or invasive fungal infections , chronic GVHD , or long-term survival between cohorts . We conclude that the benefits of palifermin appear primarily to be limited to ameliorating mucotoxicity when given to allogeneic HCT recipients .

placebo-controlled

palifermin

palifermin

palifermin

palifermin

palifermin-treated

placebo

palifermin

mucositis

early survival

CMV or invasive fungal infections

chronic GVHD

long-term survival

mucotoxicity

allogeneic HCT recipients .


Faux pas detection and intentional action in Asperger Syndrome . A replication on a French sample . In the present study , we investigated mind reading abilities in a group of adults with Asperger Syndrome ( AS ) by using the faux pas task , an advanced test of theory of mind ( Baron-Cohen et al . ( 1999 ) . Journal of Autism and Developmental Disorders , 29 , 407-418 ) . The faux pas is a particular case of a non-intentional action reflecting an involuntary socially inappropriate behavior . Here , individuals with AS over-detected faux pas stories , failed to provide correct justifications of the speaker 's behavior and were unaware of the mistaken belief and of the resulting emotional impact , whereas they appeared to be responsive to social rule violations . We hypothesized that because of an impaired theory-of-mind , individuals with AS may develop compensatory cognitive strategies based on overlearned abstract knowledge about normative rules .

Faux pas detection

faux pas

faux pas

faux pas stories

Asperger Syndrome .

group of

adults

with Asperger Syndrome ( AS )


Short-term metabolic and cardiovascular effects of metformin in markedly obese adolescents with normal glucose tolerance . OBJECTIVE Although metformin ( MET ) is an insulin sensitizer currently used as an adjunct to the treatment of some of the complications of childhood obesity besides type 2 diabetes mellitus , few studies have comprehensively examined its metabolic and clinical effects in obese children with normal glucose tolerance ( NGT ) . METHODS We therefore conducted a 4-month double-blind clinical trial in 28 obese [ mean body mass index ( BMI ) : 40.3 +/- 5.7 kg/m ( 2 ) ] , insulin-resistant [ homeostasis model assessment - insulin resistance : 7.6 +/- 2.8 and whole body insulin sensitivity index ( WBISI ) : 1.5 +/- 0.7 ] adolescents ( age 15.0 +/- 1.3 yr ) randomized to MET ( n = 15 , dose 1500 mg daily ) or placebo ( n = 13 ) . RESULTS The treatment with MET was well tolerated . MET treatment was associated with a decreased BMI ( p = 0.02 ) as well as with a reduction in subcutaneous fat ( p = 0.03 ) , particularly the deep subcutaneous fat ( p = 0.04 ) as assessed by magnetic resonance imaging . Postintervention , the MET group had a 35 % improvement in insulin sensitivity ( WBISI ) compared with the placebo group ( p = 0.008 ) . However , significance was lost with adjustments for differences in baseline insulin sensitivity ( p = 0.09 ) . While there was no change in inflammatory cytokines or lipid parameters , cardiovascular function as assessed by heart rate recovery after exercise improved with MET and worsened in placebo ( p = 0.03 ) . CONCLUSION Short-term use of MET is well tolerated by obese children with NGT and has a beneficial effect on BMI and autonomic control of the heart as well as a trend toward improved insulin sensitivity . Thus , long-term treatment with MET may provide a means to ameliorate the cardio-metabolic consequences of adolescent obesity .

metformin

metformin

placebo

placebo

body mass index ( BMI )

BMI

subcutaneous fat

deep subcutaneous fat

insulin sensitivity ( WBISI )

insulin sensitivity

inflammatory cytokines

lipid parameters

cardiovascular function

heart rate recovery

tolerated

insulin sensitivity

adolescents

normal glucose tolerance

15.0 +/- 1.3 yr

obese

NGT


Treatment of posterior uveitis with a fluocinolone acetonide implant : three-year clinical trial results . OBJECTIVES To evaluate the safety and efficacy of 0.59-mg and 2.1-mg fluocinolone acetonide ( FA ) intravitreous implants in noninfectious posterior uveitis . DESIGN A 3-year , multicenter , randomized , historically controlled trial of the 0.59-mg FA intravitreous implant in 110 patients and the 2.1-mg FA intravitreous implant in 168 patients . MAIN OUTCOME MEASURES Recurrence rate , vision , and complications . RESULTS Uveitis recurrence was reduced in implanted eyes from 62 % ( during the 1-year preimplantation period ) to 4 % , 10 % , and 20 % during the 1- , 2- , and 3-year postimplantation periods , respectively , for the 0.59-mg dose group ( P < .01 ) and from 58 % to 7 % , 17 % , and 41 % , respectively , for the 2.1-mg dose group ( P < .01 ) . More implanted eyes than nonimplanted eyes had improved visual acuity ( P < .01 ) . Implanted eyes had higher incidences of intraocular pressure elevation ( > or = 10 mm Hg ) than nonimplanted eyes ( P < .01 ) , and glaucoma surgery was required in 40 % of implanted eyes vs 2 % of nonimplanted eyes ( P < .01 ) . Cataracts were extracted in 93 % of phakic implanted eyes vs 20 % of phakic nonimplanted eyes ( P < .01 ) . CONCLUSIONS The FA implant significantly reduced uveitis recurrence and improved or stabilized visual acuity in subjects with noninfectious posterior uveitis . Most subjects required cataract extraction , and a significant proportion required intraocular pressure-lowering surgery . APPLICATION TO CLINICAL PRACTICE The FA implant provides an alternative therapy for prolonged control of inflammation in noninfectious posterior uveitis . TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT00407082 .

fluocinolone acetonide implant

fluocinolone acetonide

0.59-mg FA intravitreous implant

safety and efficacy

Recurrence rate

vision

complications

Uveitis recurrence

improved visual acuity

glaucoma surgery

Cataracts

reduced uveitis recurrence

improved or stabilized visual acuity

cataract extraction

intraocular pressure-lowering surgery

posterior uveitis

noninfectious posterior uveitis

noninfectious posterior uveitis


Efficacy of topical azithromycin ophthalmic solution 1 % in the treatment of posterior blepharitis . INTRODUCTION Azithromycin , a broad-spectrum antibiotic with potent anti-inflammatory activities , has the potential to effectively treat blepharitis , an inflammatory disease of the eyelid with abnormal eyelid flora as an etiologic determinant . The present study compared the efficacy of topical azithromycin ophthalmic solution 1 % ( AzaSite ; Inspire Pharmaceuticals , Inc , NC , USA ) combined with warm compresses ( azithromycin group ) to warm compresses alone ( compress group ) in patients with posterior blepharitis . METHODS Twenty-one patients diagnosed with posterior blepharitis were randomized in an open-label study to receive either azithromycin plus warm compresses ( 10 patients ) , or compresses alone ( 11 patients ) . All patients were instructed to apply compresses to each eye for 5-10 minutes twice daily for 14 days . Each eye in the azithromycin group also received azithromycin solution ( 1 drop ) twice daily for the first 2 days followed by once daily for the next 12 days . Patients were evaluated at study initiation ( visit 1 ) and at end of treatment ( visit 2 ) for the severity of five clinical signs : eyelid debris , eyelid redness , eyelid swelling , meibomian gland ( MG ) plugging , and the quality of MG secretion . At visit 2 , patients also rated their degree of overall symptomatic relief . RESULTS Twenty patients completed the study . At visit 2 , patients in the azithromycin group demonstrated significant improvements in MG plugging , MG secretions , and eyelid redness as compared with the compress group . In the azithromycin group , MG plugging resolved completely in three patients and MG secretion returned to normal in two patients ; no such results were seen in the compress group . Furthermore , a higher percentage of patients in the azithromycin group rated overall symptomatic relief as excellent or good . Visual acuity measurements and biomicroscopic evaluation revealed no ocular safety issues . CONCLUSION Azithromycin ophthalmic solution in combination with warm compresses provided a significantly greater clinical benefit than warm compresses alone in treating the signs and symptoms of posterior blepharitis .

azithromycin

Azithromycin

azithromycin

azithromycin

warm compresses

azithromycin

azithromycin

azithromycin

Azithromycin

Efficacy

blepharitis

eyelid debris

eyelid redness

eyelid swelling

meibomian gland ( MG ) plugging

quality of MG secretion

overall symptomatic relief

significant improvements

MG plugging

MG secretions

eyelid redness

MG plugging

MG secretion returned to normal

overall symptomatic relief

posterior blepharitis

blepharitis

inflammatory disease

Twenty-one

posterior blepharitis

Twenty


[ The CARESS-in-AMI trial ] .

CARESS-in-AMI

[ The CARESS-in-AMI trial ]


Cemented CeraOne and porcelain fused to TiAdapt abutment single-implant crown restorations : a 10-year comparative follow-up study . BACKGROUND Long-term data comparing cemented and noncemented single-implant restorations has not been reported . AIM To compare clinical and radiographic performance of single-implant crown restorations made by either directly baked porcelain to custom-made TiAdapt titanium abutments ( Nobel Biocare AB , Göteborg , Sweden ) ( test ) or cement crowns onto CeraOne ( Nobel Biocare AB ) abutments ( control ) after 10 years in function . MATERIALS AND METHODS Altogether , 35 consecutive patients were provided with 41 turned single Brånemark System implants ( Nobel Biocare AB ) in the partially edentulous upper jaw . By random , 15 and 20 patients were provided with 18 test and 23 control implant crowns , respectively . Thereafter , clinical and radiographic data were collected and compared between the two groups . RESULTS None of the implants were found loose during the follow-up period ( 100 % ) . Few clinical problems were observed , and the overall average marginal bone loss was 0.26 mm ( SD 0.64 ) during 10 years in function . After the final tightening of the crowns , no significant differences were observed between the test and control groups ( p > .05 ) . The head of the implants was placed on an average 6.3 mm ( SD 2.24 ) below the cement/enamel junction of the adjacent teeth ( range 2.5-10.0 mm ) . Implants with reported mechanical and/or mucosal problems or placed more apically in relation to the adjacent teeth did not present more bone loss as compared with implants with no problems or placed more coronally , respectively ( p > .05 ) . CONCLUSIONS There seems to be no obvious clinical or radiographic differences between the test and control single-implant restorations during 10 years of follow-up . Occasionally , some restorations presented loose abutment screws and/or fistulas during follow-up . This implies a certain need for maintenance where a one-piece single-implant protocol ( test ) allows both for a simple clinical procedure at placement without cementation problems , as well as for an easy and simple maintenance of installed single implant crowns in long-term function .

cemented

noncemented single-implant restorations

single-implant crown restorations

clinical and

radiographic performance


Human recombinant GM-CSF in allogeneic bone marrow transplantation for leukaemia : double-blind placebo controlled trial . A double-blind randomised trial compared 20 patients with leukaemia receiving human recombinant granulocyte macrophage colony stimulating factor ( GM CSF ) , with 20 patients receiving placebo for 14 days after allogeneic matched sibling bone marrow transplantation . The median neutrophil count at 14 days was significantly higher in the GM CSF group ( 1.90 vs. 0.46 x 10 ( 9 ) /l ) . The duration of hospital stay , the number of antibiotic days , and the number of fever days was the same for both patient groups . The lymphocyte count was significantly higher in the GM-CSF group than in the placebo group between days 10 and 15 after transplantation . The GM-CSF group had lower haemoglobin concentrations and platelets counts , and higher plasma urea creatinine and bilirubin , than the placebo group . There was no evidence that GM CSF was associated with a greater incidence of leukaemic relapse .

Human recombinant GM-CSF

placebo

GM CSF

GM-CSF

placebo

GM-CSF

GM CSF

median neutrophil count

the number of fever days

lymphocyte count

leukaemic relapse .

leukaemia


Extinction of over-selected stimuli causes emergence of under-selected cues in higher-functioning children with autistic spectrum disorders . Two experiments examined whether over-selectivity is the product of a post-acquisition performance deficit , rather than an attention problem . In both experiments , children with Autistic Spectrum Disorder were presented with a trial-and-error discrimination task using two , two-element stimuli and over-selected in both studies . After behavioral control by the previously over-selected stimulus was extinguished , behavioral control by the previously under-selected cue emerged without direct training . However , this effect was only found in higher-functioning children , and not with more severely impaired children . These findings suggest that over-selectivity is not simply due to a failure to attend to all of the stimuli presented . They also suggest that extinction of over-selected stimuli may be a fruitful line of intervention for clinical intervention for some individuals .

trial-and-error discrimination task

two , two-element stimuli

over-selected

over-selected stimuli

emergence

under-selected cues

post-acquisition performance deficit

over-selected stimulus

behavioral control

over-selectivity

extinction of over-selected stimuli


Effects of aspirin and clopidogrel in healthy men measured by platelet aggregation and PFA-100 . There are no generally accepted definitions for low-response ( frequently called resistance ) to the platelet inhibitors , aspirin and clopidogrel . Low-response may increase the risk of cardiovascular events in atherosclerotic patients . We aimed to define the normal drug responses in healthy men . Platelet function was measured in 20 healthy men during 11 days of aspirin or clopidogrel intake , using light transmission aggregometry ( LTA ) and the Platelet Function Analyzer 100 ( PFA-100 ) . The lower limits for LTA at baseline were 64 % and 61 % , using arachidonic acid and ADP as agonists , respectively . During aspirin intake the LTA results were stable from day to day , and an upper limit of 9 % arachidonic acid stimulated aggregation was found . Clopidogrel intake was best shown by ADP induced aggregation . However , two out of 20 individuals exhibited low-response to clopidogrel . In the remaining 18 volunteers an upper limit of 48 % aggregation was found . We found an upper limit for collagen-epinephrine stimulated PFA-100 results of 166 s at baseline . During aspirin intake , these results varied considerably from day to day in nine out of 20 men , resulting in an overlap between the reference ranges at baseline and during therapy . In conclusion , platelet inhibition by aspirin and clopidogrel assessed by aggregometry was stable during 11 days of treatment and reference ranges were established . The PFA-100 results varied greatly and low-response was not precisely defined by this method .

aspirin

clopidogrel

aspirin

clopidogrel .

aspirin

clopidogrel

aspirin

Clopidogrel

clopidogrel

aspirin

aspirin

clopidogrel

LTA results

arachidonic acid stimulated aggregation

Clopidogrel intake

low-response to clopidogrel .


A randomized trial of etoposide and G-CSF with or without rituximab for PBSC mobilization in B-cell non-Hodgkin 's lymphoma . Some reports have suggested that rituximab administration before PBSC mobilization may adversely affect PBSC yield . We conducted a prospective randomized trial of PBSC mobilization using etoposide and G-CSF with or without rituximab to determine whether its addition would adversely affect CD34+ cell yield in patients with non-Hodgkin 's lymphoma . Twenty seven patients were mobilized with etoposide and G-CSF and 28 with etoposide , G-CSF and rituximab . There were no adverse consequences of rituximab on CD34+ cell yield , or hematopoietic recovery or immunoglobulin levels after transplantation .

rituximab

etoposide

etoposide , G-CSF and rituximab

B-cell non-Hodgkin 's lymphoma

non-Hodgkin 's lymphoma

Twenty seven


Results of the EICESS-92 Study : two randomized trials of Ewing 's sarcoma treatment -- cyclophosphamide compared with ifosfamide in standard-risk patients and assessment of benefit of etoposide added to standard treatment in high-risk patients . PURPOSE The European Intergroup Cooperative Ewing 's Sarcoma Study investigated whether cyclophosphamide has a similar efficacy as ifosfamide in standard-risk ( SR ) patients and whether the addition of etoposide improves survival in high-risk ( HR ) patients . PATIENTS AND METHODS SR patients ( localized tumors , volume < 100 mL ) were randomly assigned to receive four courses of vincristine , dactinomycin , ifosfamide , and doxorubicin ( VAIA ) induction therapy followed by 10 courses of either VAIA or vincristine , dactinomycin , cyclophosphamide , and doxorubicin ( VACA ; cyclophosphamide replacing ifosfamide ) . HR patients ( volume > or=100 mL or metastases ) were randomly assigned to receive 14 courses of either VAIA or VAIA plus etoposide ( EVAIA ) . Outcome measures were event-free survival ( EFS ; defined as the time to first recurrence , progression , second malignancy , or death ) and overall survival ( OS ) . RESULTS A total of 647 patients were randomly assigned : 79 SR patients were assigned to VAIA , 76 SR patients were assigned to VACA , 240 HR were assigned to VAIA , and 252 HR patients were assigned to EVAIA . The median follow-up was 8.5 years . In the SR group , the hazard ratios ( VACA v VAIA ) for EFS and OS were 0.91 ( 95 % CI , 0.55 to 1.53 ) and 1.08 ( 95 % CI , 0.58 to 2.03 ) , respectively . There was a higher incidence of hematologic toxicities in the VACA arm . In the HR group , the EFS and OS hazard ratios ( EVAIA v VAIA ) indicated a 17 % reduction in the risk of an event ( 95 % CI , -35 % to 5 % ; P = .12 ) and 15 % reduction in dying ( 95 % CI , -34 % to 10 % ) , respectively . The effect seemed greater among patients without metastases ( hazard ratio = 0.79 ; P = .16 ) than among those with metastases ( hazard ratio = 0.96 ; P = .84 ) . CONCLUSION Cyclophosphamide seemed to have a similar effect on EFS and OS as ifosfamide in SR patients but was associated with increased toxicity . In HR patients , the addition of etoposide seemed to be beneficial .

cyclophosphamide

ifosfamide

etoposide

cyclophosphamide

ifosfamide

etoposide

VAIA

VAIA

etoposide ( EVAIA )

VAIA

VACA

VAIA

EVAIA

survival

event-free survival ( EFS

overall survival ( OS ) .

hazard ratios

hematologic toxicities

EFS and OS hazard ratios

EFS and OS

toxicity


Randomized controlled trial of collaborative care management of depression among low-income patients with cancer . PURPOSE To determine the effectiveness of the Alleviating Depression Among Patients With Cancer ( ADAPt-C ) collaborative care management for major depression or dysthymia . PATIENTS AND METHODS Study patients included 472 low-income , predominantly female Hispanic patients with cancer age > or= 18 years with major depression ( 49 % ) , dysthymia ( 5 % ) , or both ( 46 % ) . Patients were randomly assigned to intervention ( n = 242 ) or enhanced usual care ( EUC ; n = 230 ) . Intervention patients had access for up to 12 months to a depression clinical specialist ( supervised by a psychiatrist ) who offered education , structured psychotherapy , and maintenance/relapse prevention support . The psychiatrist prescribed antidepressant medications for patients preferring or assessed to require medication . RESULTS At 12 months , 63 % of intervention patients had a 50 % or greater reduction in depressive symptoms from baseline as assessed by the Patient Health Questionnaire-9 ( PHQ-9 ) depression scale compared with 50 % of EUC patients ( odds ratio [ OR ] = 1.98 ; 95 % CI , 1.16 to 3.38 ; P = .01 ) . Improvement was also found for 5-point decrease in PHQ-9 score among 72.2 % of intervention patients compared with 59.7 % of EUC patients ( OR = 1.99 ; 95 % CI , 1.14 to 3.50 ; P = .02 ) . Intervention patients also experienced greater rates of depression treatment ( 72.3 % v 10.4 % of EUC patients ; P < .0001 ) and significantly better quality-of-life outcomes , including social/family ( adjusted mean difference between groups , 2.7 ; 95 % CI , 1.22 to 4.17 ; P < .001 ) , emotional ( adjusted mean difference , 1.29 ; 95 % CI , 0.26 to 2.22 ; P = .01 ) , functional ( adjusted mean difference , 1.34 ; 95 % CI , 0.08 to 2.59 ; P = .04 ) , and physical well-being ( adjusted mean difference , 2.79 ; 95 % CI , 0.49 to 5.1 ; P = .02 ) . CONCLUSION ADAPt-C collaborative care is feasible and results in significant reduction in depressive symptoms , improvement in quality of life , and lower pain levels compared with EUC for patients with depressive disorders in a low-income , predominantly Hispanic population in public sector oncology clinics .

intervention

enhanced usual care

structured psychotherapy

maintenance/relapse prevention support

antidepressant medications

ADAPt-C collaborative care

major depression

depressive symptoms

PHQ-9 score

greater rates of depression treatment

better quality-of-life outcomes

emotional

physical well-being

Patients With Cancer


CASTLE data show no gender differences .

CASTLE data

data show no

differences


Methotrexate in the treatment of steroid-dependent asthma . A double-blind , placebo-controlled , crossover study was designed to compare steroid requirements between placebo and methotrexate ( MTX ) treatment in subjects with corticosteroid-requiring asthma . Subjects began with a steroid taper and then were randomized to a 3-month trial of drug or placebo therapy . Subjects received 15 mg of MTX a week or identical placebo . A 1-month washout period was completed before the crossover trial . Symptom scores , peak flow rates , spirometry , and beta-agonist frequency were closely monitored . Ten subjects completed the study . The average dose of prednisone during the placebo-treatment period was 11.97 mg/day compared to 8.37 mg/day while subjects were taking MTX . This was a 30 % reduction in daily steroid requirement ( p less than 0.01 ) . Symptom scores and spirometry did not differ between the crossover trials , and overall clinical status was not altered . Complications from MTX were mild and included anorexia , alopecia , and stomatitis . All complications resolved with dose reduction or when MTX was stopped at the end of the study . No subjects withdrew from the study because of MTX complications . Low-dose MTX significantly reduced the steroid requirement in this group of subjects with steroid-dependent asthma . This reduction in steroid requirement was obtained without altering clinical status and without significant complication .

Methotrexate

placebo-controlled

placebo

methotrexate

placebo therapy .

MTX

placebo .

placebo-treatment

MTX

MTX

MTX

MTX

MTX

steroid requirements

Symptom scores

peak flow rates

spirometry

beta-agonist frequency

daily steroid requirement

Symptom scores

spirometry

Complications from MTX

anorexia , alopecia , and stomatitis

complications

steroid requirement

reduction in steroid requirement

steroid-dependent asthma

asthma

Ten subjects

asthma


Monitoring of the central pulse pressure is useful for detecting cardiac overload during antiadrenergic treatment : the Japan Morning Surge 1 study . OBJECTIVE Lowering of the central pulse pressure ( PP ) has been shown to contribute to an improvement of the cardiac damage beyond that of lowering the brachial PP . We assessed the hypothesis that the change in the central PP is more useful than that in the brachial PP in the assessment of the change in cardiac load . METHODS We studied 434 treated hypertensive patients whose home systolic blood pressure was 135 mmHg or higher . They were followed for 6 months after allocation to either a control group or an added treatment group ( doxazosin 1-4 mg and atenolol when needed ) . We measured the brachial and central ( carotid ) blood pressure simultaneously using a validated device , and the B-type natriuretic peptide at baseline and at the sixth month of treatment . RESULTS In the added treatment group , the brachial systolic blood pressure was successfully reduced , but the central PP increased significantly , whereas the other blood pressure parameters did not change from the baseline . In the added treatment group , the change in the B-type natriuretic peptide was significantly correlated with the change in the brachial PP ( r = 0.18 ) , central systolic blood pressure ( r = 0.18 ) , central PP ( r = 0.26 ) , and PP amplification ( r = -0.22 ) even after adjusting for the confounding factors . The correlation with the central PP was stronger than with the brachial PP ( P = 0.018 ) or central systolic blood pressure ( P = 0.002 ) , and these relationships were essentially the same even after adjustment for the use of atenolol or the change in heart rate . CONCLUSION This study showed that the central PP measurement may be more important to assess cardiac load than the brachial PP during antiadrenergic treatment .

control group

doxazosin 1-4 mg

atenolol

atenolol

antiadrenergic treatment

central pulse pressure

central pulse pressure

brachial systolic blood pressure

central PP

brachial PP

central systolic blood pressure

central PP

PP amplification

brachial PP

central systolic blood pressure

central PP measurement

hypertensive patients


Endobronchial ultrasonography-guided transbronchial needle aspiration increases the diagnostic yield of peripheral pulmonary lesions : a randomized trial . BACKGROUND The diagnostic yield of endobronchial ultrasonography ( EBUS ) -guided transbronchial needle aspiration ( TBNA ) for peripheral pulmonary lesions ( PPLs ) has not been evaluated . The diagnostic impact of TBNA when the EBUS probe is adjacent to lesions remains to be determined . DESIGN A prospective , randomized trial . METHODS Two hundred two patients with PPLs and positive EBUS findings were enrolled . They were randomly classified into two groups . In the EBUS conventional diagnostic procedures ( CDPs ) group ( 103 patients ) , both transbronchial biopsy ( TBB ) and bronchial washing ( BW ) were performed . In the EBUS-TBNA plus CDPs group ( 99 patients ) , TBNA , TBB , and BW were performed . The diagnostic yield in each group was compared . RESULTS A total of 182 patients ( 94 in the EBUS CDPs group and 88 in the EBUS-TBNA plus CDPs group ) were analyzed . The yield in the EBUS-TBNA plus CDPs group ( 78.4 % ) was significantly higher than the EBUS CDPs group ( 60.6 % , p = 0.015 ) . Cases in which the EBUS probe was located within the lesions had a significantly higher diagnostic yield ( 78.3 % ) than when the EBUS probe was adjacent to them ( 47.2 % , p < 0.001 ) . Concerning the three different techniques , TBNA showed the highest diagnostic yield ( 62.5 % ) in comparison to TBB ( 48.9 % ) and to BW ( 19.8 % ) . The diagnostic yield of TBNA remained unchanged even when the EBUS probe was adjacent to the lesions ( p = 0.89 ) . No additional adverse effects were observed in the EBUS-TBNA plus CDPs group . CONCLUSIONS Applying TBNA to EBUS-guided CDPs further increased the diagnostic yield of PPLs without additional risk . The diagnostic advantage of TBNA became more obvious if the EBUS probe was adjacent to the lesions . TRIAL REGISTRATION Clinicaltrials.gov Identifier : NCT00626587 .

transbronchial needle aspiration

transbronchial biopsy

diagnostic yield

diagnostic yield

diagnostic yield

yield in the EBUS-TBNA

higher diagnostic yield

highest diagnostic yield

diagnostic yield of TBNA

adverse effects

diagnostic yield

diagnostic advantage

peripheral pulmonary lesions :


Influence of phase-related variability in premenstrual symptomatology , mood , smoking withdrawal , and smoking behavior during ad libitum smoking , on smoking cessation outcome . Emerging evidence suggests that women have a more difficult time quitting smoking than men-possibly due , in part , to sex hormones . The present study characterized mood , premenstrual symptomatology , and smoking withdrawal , as well as smoking behavior , in the follicular and luteal phases during ad libitum smoking in 25 women intending to quit . We also investigated the possible influence of phase-related variability in these measures on likelihood of study adherence and smoking cessation . We found that premenstrual symptomatology , as well as some measures of mood and smoking withdrawal , were significantly higher during the luteal phase than in the follicular phase . Cigarettes/day did not vary by menstrual cycle phase . Phase-related variability in premenstrual symptomatology [ F ( 3 , 20 ) =2.82 , p=0.0650 ) ] and urge to smoke [ F ( 2 , 21 ) =4.85 , p=0.0186 ) ] were associated with relapse . These data support the inference that sex hormones influence smoking cessation outcome . This knowledge may contribute to the development of more rational and effective smoking cessation interventions for women .

ad libitum smoking

premenstrual symptomatology

mood

smoking withdrawal

smoking cessation outcome

quitting smoking

mood

premenstrual symptomatology

smoking withdrawal

smoking behavior

premenstrual symptomatology

measures of mood

smoking withdrawal

Cigarettes/day

Phase-related variability

urge to smoke

smoking cessation outcome .

premenstrual

women


Safety of ferumoxytol in patients with anemia and CKD . BACKGROUND Iron deficiency anemia is a common complication in patients with chronic kidney disease ( CKD ) . Currently available intravenous ( IV ) iron replacement therapies have either inconvenient regimens of administration or adverse event profiles that limit their utility in the outpatient setting . Ferumoxytol is a novel , semisynthetic , carbohydrate-coated , superparamagnetic iron oxide nanoparticle that is administered IV as an injection . The main objective of this study was to assess the safety of ferumoxytol for the treatment of patients with CKD stages 1 to 5 and 5D . STUDY DESIGN Phase 3 , randomized , double-blind , placebo-controlled , crossover , multicenter study of a single 510-mg dose of ferumoxytol versus saline as placebo . SETTING & PARTICIPANTS 750 patients with CKD stages 1 to 5 and 5D . INTERVENTION An IV injection of either 17 mL of ferumoxytol or saline placebo over 17 seconds on day 0 and the alternate agent on day 7 . OUTCOMES & MEASUREMENTS Descriptive comparison of adverse events , laboratory tests , and vital signs . RESULTS Of 750 randomly assigned patients with CKD , 60 % were not on dialysis therapy . 713 patients received ferumoxytol , and 711 received placebo . There were 420 adverse events reported ; 242 in 152 patients ( 21.3 % ) with ferumoxytol and 178 in 119 patients ( 16.7 % ) with placebo . The incidence of related adverse events was 5.2 % with ferumoxytol and 4.5 % with placebo . The most common related adverse events after each treatment included symptoms related to the injection/infusion site , dizziness , pruritus , headache , fatigue , and nausea . Serious adverse events occurred in 21 patients ( 2.9 % ) after ferumoxytol and 13 patients ( 1.8 % ) after placebo . Serious related adverse events were observed in 1 patient ( 0.1 % ) after each treatment . There was no meaningful decrease in blood pressure after administration of ferumoxytol or placebo . LIMITATIONS Follow-up was 7 days after each study treatment . CONCLUSIONS Ferumoxytol is well tolerated and has a safety profile similar to placebo in anemic patients with CKD stages 1 to 5 and 5D .

ferumoxytol

iron replacement therapies

Ferumoxytol

ferumoxytol

placebo-controlled

ferumoxytol

saline

as placebo

ferumoxytol

saline

placebo

dialysis therapy

ferumoxytol

placebo

placebo

ferumoxytol

placebo

ferumoxytol

placebo

ferumoxytol

placebo

Ferumoxytol

placebo

Safety

safety

adverse events

laboratory tests

vital signs

adverse events

incidence of related adverse events

adverse events

symptoms

Serious related adverse events

blood pressure

tolerated

safety profile

anemia and CKD

chronic kidney disease ( CKD )

CKD stages 1 to 5 and 5D

CKD stages 1 to 5 and 5D

CKD

anemic

CKD stages 1 to 5 and 5D


A multifactorial strategy of pain management is associated with less pain in scheduled vaccination of children . A study realized by family practitioners in 239 children aged 4-12 years old . BACKGROUND AND AIMS The multiplicity of vaccine injections during childhood leads to iterative painful and stressful experiences which may lead in turn to anticipated pain and then possibly to a true needle phobia . We aimed at evaluating a multifactorial strategy of pain management combining pharmacological and non-pharmacological approaches during vaccination , as compared to usual care , in 4- to 12-year-old children . METHODS In all , 239 children were enrolled by 25 family practitioners in an open-label study . After a pseudo-randomization , usual pain management ( n = 132 ) was compared to a multifactorial strategy ( n = 107 ) associating preliminary application of an anesthesic patch , preferential use of specified vaccines , child education by the parents and the doctor , parental accompaniment and child distraction with soap bubbles during the procedure . The primary outcome ( i.e . child pain ) was assessed with a self-report scale named visual analog scale ( VAS ) of pain . RESULTS A significant decrease in pain was obtained using the multifactorial strategy , as assessed by self-reported VAS ( P < 0.0001 ) . This was confirmed by another self-report scale ( the facial pain scale revised : P = 0.005 ) , as well as with hetero-evaluations by GPs and parents [ Children 's Hospital of Eastern Ontario Pain Scale : P = 0.0007 ; GPs VAS ( P < 0.0001 ) , parents VAS ( P < 0.0001 ) ] , which were secondary outcome criteria . CONCLUSIONS This multifactorial method significantly decreases vaccination pain in 4- to 12-year-old children . This strategy could make vaccines more acceptable to children and may improve child-doctor relationships and contribute to a decrease in child fear about health care .

child pain )

pain

facial pain scale

parents VAS

pain


The value of transbronchial lung biopsy using jumbo forceps via rigid bronchoscope in diffuse lung disease . BACKGROUND Transbronchial lung biopsy ( TBLB ) is a valuable procedure used to obtain a parenchymal specimen in the evaluation of diffuse lung infiltrates . Large forceps are expected to result in larger specimens and improve diagnostic yield . AIM The objective of this study was to evaluate diagnostic yield of TBLB using large modified flexible gastroenterological forceps ( " Jumbo forceps " ) compared with 'normal ' flexible forceps via rigid bronchoscopy in patients with diffuse parenchymal lung disease ( DPLD ) . METHODS The study was a prospective analysis of 95 patients who underwent fluoroscopy guided TBLB over a two year period . Patients with a lung mass or solitary lung nodule undergoing TBLB were excluded . The larger and small forceps were used in a random sequence to avoid a reduction in diagnostic yield of the second series of biopsies related to possible bleeding by first series of biopsies . To minimize the consequence of haemorrhage , we performed every rigid bronchoscopy , placing a non inflated Fogarty balloon and a rigid aspirator ( diameter 4 mm ) in lobar bronchus near the biopsy segment . The Fogarty balloon has been inflated in case of bleeding . After the bleeding was controlled we continued to operate up to the biopsy segment . RESULTS Diagnostic yield of TBLB using Jumbo forceps was significantly higher than using normal flexible forceps via rigid bronchoscopy in patients with DPLD ( p = 0.001 ) . In 74 out of 95 patients ( 78 % ) the diagnosis was placed with Jumbo forcep while the smaller forcep was diagnostic in 62 out of 95 patients ( 65 % ) . Large forceps obtained significantly more tissue than the small forceps ; the biopsy specimen taken with normal forcep measured in average 1.4 x 1.0 mm and the larger biopsy taken with jumbo forcep measured in average 2.5 x 1.9 mm ( p < 0.005 ) . CONCLUSION The use of large biopsy forceps to perform TBLB via rigid bronchoscope can significantly increase diagnostic yield in the pathological diagnosis of diffuse infiltrative lung disease .

larger and small forceps

bronchoscopy

placing a non inflated Fogarty balloon

rigid aspirator

value of transbronchial lung biopsy

parenchymal specimen

Diagnostic yield

tissue

diffuse lung disease

diffuse parenchymal lung disease ( DPLD

lung mass

lung nodule

DPLD

78 %

65 %

diffuse infiltrative lung disease


Physical health -- a cluster randomized controlled lifestyle intervention among persons with a psychiatric disability and their staff . The objective was to explore the impact on physical health of a lifestyle programme among persons with psychiatric disabilities , and their caregivers . Their satisfaction with the intervention was also assessed . Somatic comorbidity and an increased mortality related to the lifestyle among persons with psychiatric disabilities are well known . Few randomized controlled trials have been aimed specifically at lifestyle issues among persons with a psychiatric disability . This trial includes clients with psychiatric disabilities living in supported housing and their staff . Forty-one persons with a DSM- ? V diagnosis of severe mental illness from psychiatric disability from 10 supported housing facilities and 41 of their caregivers participated in this 12-month study during 2005-2006 in Sweden . The supported housing facilities with residents and staff were randomly assigned to either a health intervention programme or a control programme with an aesthetic content . The presence of metabolic syndrome and changes in the mean of physiological parameters such as Hba1c , P-glucose , P-insulin , lipids , blood pressure , physical working capacity , body mass index , Heart Score were investigated and participants ' satisfaction assessed . There was a significant reduction in the mean of metabolic syndrome criteria in the intervention group compared with the control group at the follow-up . The participants expressed satisfaction with the programme . The results indicate that health interventions on lifestyle issues when involving carers are appreciated , feasible and could be successful in reducing some health-related risk factors among persons with psychiatric disabilities .

lifestyle programme

health intervention programme

health interventions

participants ' satisfaction

mean of metabolic syndrome criteria

health-related risk factors

carers


Medium chain triglyceride oil consumption as part of a weight loss diet does not lead to an adverse metabolic profile when compared to olive oil . OBJECTIVE Medium chain triglyceride ( MCT ) consumption may have a beneficial impact on weight management , however , some studies point to a negative impact of MCT oil consumption on cardiovascular disease risk . This study examined the effects of MCT oil consumption , as part of a weight loss diet , on metabolic risk profile compared to olive oil . DESIGN Thirty-one men and women , age 19-50 y and body mass index 27-33 kg/m ( 2 ) , completed this randomized , controlled , 16-week weight loss program . Oils were consumed at a level of approximately 12 % of the subjects ' prescribed energy intakes in the form of muffins and liquid oil . RESULTS After controlling for body weight , there was a significant effect of time on fasting serum glucose ( P = 0.0177 ) and total cholesterol ( P = 0.0386 ) concentrations , and on diastolic blood pressure ( P = 0.0413 ) , with reductions in these variables occurring over time ; there was no time-by-diet interaction for any of the parameters studied . Two of the 3 subjects in the MCT oil group with evidence of the metabolic syndrome at baseline did not have metabolic syndrome at endpoint . In the olive oil group , 6 subjects had the metabolic syndrome at baseline ; 2 subjects no longer had metabolic syndrome at endpoint , 1 person developed metabolic syndrome , and 4 subjects did not have any change in their metabolic syndrome status . CONCLUSIONS Our results suggest that MCT oil can be incorporated into a weight loss program without fear of adversely affecting metabolic risk factors . Distinction should be made regarding chain length when it comes to discussing the effects of saturated fats on metabolic risk factors .

Medium chain triglyceride oil

Medium chain triglyceride ( MCT )

MCT oil

MCT oil consumption

liquid oil

MCT oil

olive oil

MCT oil

fasting serum glucose

total cholesterol

diastolic blood pressure

Thirty-one

men and women

age 19-50 y

body mass index 27-33 kg/m ( 2 )

MCT oil

metabolic syndrome

metabolic syndrome


Allopurinol use yields potentially beneficial effects on inflammatory indices in those with recent ischemic stroke : a randomized , double-blind , placebo-controlled trial . BACKGROUND AND PURPOSE Elevated serum uric acid level is associated with poor outcome and increased risk of recurrent events after stroke . The xanthine oxidase inhibitor allopurinol lowers uric acid but also attenuates expression of inflammatory adhesion molecules in murine models , reduces oxidative stress in the vasculature , and improves endothelial function . We sought to investigate whether allopurinol alters expression of inflammatory markers after acute ischemic stroke . METHODS We performed a randomized , double-blind , placebo-controlled trial to investigate the safety , tolerability , and effect of 6 weeks ' treatment with high- ( 300 mg once a day ) or low- ( 100 mg once a day ) dose allopurinol on levels of uric acid and circulating inflammatory markers after ischemic stroke . RESULTS We enrolled 50 patients with acute ischemic stroke ( 17 , 17 , and 16 in the high , low , and placebo groups , respectively ) . Mean ( +/-SD ) age was 70 ( +/-13 ) years . Groups had similar characteristics at baseline . There were no serious adverse events . Uric acid levels were significantly reduced at both 7 days and 6 weeks in the high-dose group ( by 0.14 mmol/L at 6 weeks , P=0.002 ) . Intercellular adhesion molecule-1 concentration ( ng/mL ) rose by 51.2 in the placebo group , rose slightly ( by 10.6 ) in the low-dose allopurinol group , but fell in the high-dose group ( by 2.6 ; difference between groups P=0.012 , Kruskal-Wallis test ) . CONCLUSIONS Allopurinol treatment is well tolerated and attenuates the rise in intercellular adhesion molecule-1 levels seen after stroke . Uric acid levels were lowered with high doses . These findings support further evaluation of allopurinol as a preventive measure after stroke .

Allopurinol

allopurinol

allopurinol

placebo

allopurinol

Allopurinol

allopurinol

Uric acid levels

those with recent ischemic stroke :


Levels of opioid physical dependence in heroin addicts . The levels of opioid physical dependence in a group of long-term heroin addicts were ascertained by measuring the severity of the opioid withdrawal syndrome before and after pharmacological challenge with either 0.4 mg naloxone or placebo . Prior to challenge , patients manifested some subjective symptoms but few objective signs of opioid withdrawal . Patients who received placebo ( n = 18 ) showed a significant increase in the mean score on one of three rating scales used to assess opioid withdrawal . Patients who received naloxone ( n = 58 ) showed significant increases in mean scores on all three rating scales , but this was due primarily to increases observed in a minority of patients . Sixty-one percent of patients failed to manifest clinically significant changes in subjective symptoms , and 74 % of patients failed to manifest clinically significant changes in objective signs of opioid withdrawal following naloxone administration . The results suggest that a substantial subgroup of heroin addicts are able to use opioids regularly while maintaining relatively low levels of physical dependence .

naloxone

placebo

placebo

naloxone

naloxone

opioid withdrawal syndrome

subjective symptoms

subjective symptoms

objective signs of opioid withdrawal

opioid physical dependence

heroin addicts

heroin addicts


Safety and immunogenicity of a cluster specific immunotherapy in children with bronchial asthma and mite allergy . BACKGROUND Cluster specific immunotherapy ( SIT ) is a modern form of allergen immunotherapy allowing safe administration of high allergen doses in a short time interval compared to classic SIT . In the current study , we investigated the safety profile and immunological effect of cluster SIT in children with allergic asthma due to house dust mite allergy . METHODS A total of 34 children ( 6-18 years ) with allergic asthma were assigned to cluster ( n = 22 ) or classic SIT ( n = 12 ) . To achieve a maintenance dose of allergen extract , cluster patients received 14 injections of house dust mite allergen within 6 weeks , whereas the classic SIT group received 14 injections within 14 weeks . Safety was monitored by recording adverse events . Immunogenicity was measured by specific IgG ( Mite ) and IgG4 ( Mite ) , by antibody-blocking properties on basophil activation , and by the T cell subset transcription factors Foxp3 , T-bet , and GATA-3 . RESULTS There were no significant differences in local and systemic side effects between the two groups . In the cluster group , serum levels of specific IgG ( Mite ) ( p < 0.001 ) and specific IgG4 ( Mite ) ( p < 0.001 ) significantly increased after 8 weeks , while it took 12 weeks in the classic SIT group . These data were confirmed by blocking CD63 expression as well as release of cysteinyl leukotrienes after in vitro basophil stimulation . No differences in transcription factor expression were found in the two groups . CONCLUSION Cluster SIT is safe in children . Additionally , our data demonstrated an even more rapid induction of specific immune tolerance . Cluster SIT is an attractive alternative to conventional up-dosing schedules with fewer consultations for the patients .

cluster specific immunotherapy

Cluster specific immunotherapy ( SIT )

Safety

and immunogenicity

safety profile and immunological effect

Safety

Immunogenicity

local and systemic side effects

serum levels of specific IgG ( Mite )

specific IgG4 ( Mite )

CD63 expression

transcription factor expression

induction of specific immune tolerance

classic SIT ( n = 12 ) .


Development of autistic children based on maternal responses to the Autism Behavior Checklist . BACKGROUND language and speech-language intervention . AIM to evaluate the development process of autistic children , in a direct and indirect intervention context based on the responses of mothers to the Autism Behavior Checklist . METHOD the research sample consisted of 11 mothers of children diagnosed , according to the criteria established by the DSM IVtr ( APA , 2002 ) , with autism ( six ) and with Asperger Syndrome ( five ) and who were seen at the Investigation Laboratory of Global Developmental Disorders of the Federal University of São Paulo . These children were randomly divided into two groups : Six were receiving both direct and indirect intervention ( TG ) , and five were receiving indirect intervention exclusively ( OG ) . The Autism Behavior Checklist ( Krug et al. , 1993 ) was used , adapted to the Portuguese language by Marteleto ( 2003 ) . This behavior checklist ( 57 items ) allows the detailed description of non-adaptable characteristics regarding the following areas : sensory , use of the body and object , Language , Psycho-social and Relational . The questionnaire was filled in during an interview on three occasions : at the beginning of intervention , after six months and at the end of 12 months . RESULTS after statistical analysis it was observed that there was a greater development in the total scores and in the areas of language , psycho-social and relational for the TG . This suggests a greater development pattern during the studied period for this group . CONCLUSION the mothers of both groups observed behavioral changes . The better scores observed for the TG is probably related to the effectiveness of direct intervention , and not to the lack of attention of parents in the OG in recognizing behavioral changes in their children .

direct and indirect intervention

Autism Behavior Checklist

autistic children


The effect of trandolapril and its fixed-dose combination with verapamil on circulating adhesion molecules levels in hypertensive patients with type 2 diabetes . BACKGROUND AND AIM Endothelial dysfunction in hypertensive type-2 diabetic patients is associated with increased levels of circulating soluble adhesion molecules ( SAM ) . SAM participate in the development of diabetic macroangiopathy and microangiopathy . The aim of this study was to compare the effect of trandolapril ( T ) and its fixed-dose combination with verapamil ( FDTV ) on SAM levels in hypertensive type-2 diabetic patients . METHODS Forty type-2 diabetic patients with never-treated hypertension were randomly assigned to two groups . One group ( FDTV ) received 2/180 mg once a day ; the other group received T 2 mg once a day . Study drugs were administered for three months in both groups . VCAM-1 , ICAM , and E-selectin were measured by ELISA at the beginning and end of the study . Patients were evaluated monthly for blood pressure , fasting serum glucose , and adverse events . Statistical analysis was performed with ANOVA . RESULTS Both therapeutics regimens reduced significantly the levels of the SAM tested . When both groups were compared , we did not find a significant difference in ICAM and E-selectin reduction . However , VCAM-1 presented a significantly greater reduction ( p = 0.022 ) in the trandolapril-verapamil group . No patient suffered adverse events . CONCLUSION Our results show that FDTV produces a greater reduction of VCAM-1 circulating levels than trandolapril alone . This may explain some of the beneficial effects of this fixed dosed combination that are non-related to its antihypertensive effects .

trandolapril

verapamil

trandolapril ( T )

verapamil ( FDTV )

( FDTV )

T

trandolapril-verapamil

soluble adhesion molecules ( SAM )

ICAM

E-selectin

levels of the SAM tested

ICAM

E-selectin reduction

adverse events .

hypertensive type-2 diabetic

hypertensive type-2 diabetic

Forty

type-2 diabetic

hypertension


Bacterial ribosomal immunostimulants prime alveolar macrophages in vivo to produce interleukin 1 in vitro . Alveolar macrophages ( AMs ) may play a key role in human respiratory immune defenses , partially by synthesizing and releasing interleukin 1 ( IL = 1 ) . D53 ( Ribomunyl ) , a composite bacterial ribosomal immunostimulant , has been recognized as an efficient prevention of respiratory tract infections . In vitro , D53 enhances the IL-1 production by mouse spleen adherent cells . A thymocyte proliferative response assay was used to evaluate the in vitro IL-1 production by AMs in healthy subjects who received D53 immunostimulant . Twelve nonsmoking healthy subjects took part in a prospective double-blind placebo control study . On day 1 , a first bronchoalveolar lavage ( BAL ) was performed to assess IL-1 production by unstimulated and lipopolysaccharide ( LPS ) stimulated AM . Then , subjects were randomized to receive D53 ( n = 6 ) or its placebo ( n = 6 ) by both oral and subcutaneous injection routes from day 1 to day 15 . On day 15 , a second BAL was done and AM IL-1 production was again tested . IL-1 production on day 15 did not significantly differ from day 1 in both D53-treated and placebo groups either when AMs were unstimulated or were stimulated with concentrations of LPS resulting in maximal IL-1 production . However , in the D53-treated group , but not in the placebo group , IL-1 production induced by low LPS concentration ( 5 mg/L ) was significantly higher ( mean +/- SEM : 1,238 +/- 287 U/10 ( 6 ) AM ) on day 15 in comparison with day 1 ( 577 +/- 113 U/10 ( 6 ) AM ; p less than 0.05 , Wilcoxon W test ) and in comparison with the control group ( day 15 IL-1 production induced by 5 mg/L LPS , 758 +/- 175 U/10 ( 6 ) AM ; p less than 0.05 , Mann-Whitney U test ) . Moreover , in the D53-treated group , the optimal LPS concentration ( ie , LPS concentration that induced maximal IL-1 production ) was significantly lower on day 15 ( mean +/- SD : 11 +/- 7 mg/L ) than on day 1 ( 16 +/- 7 mg/L ; p less than 0.05 Wilcoxon W test ) . We conclude that D53 immunostimulant in vivo primes AM to produce IL-1 following low LPS concentration stimulation . This may partially explain the protective effect of D53 immunostimulant against respiratory tract infection .

Bacterial ribosomal immunostimulants

D53 ( Ribomunyl )

D53 immunostimulant

placebo

D53 immunostimulant

D53 immunostimulant

IL-1 production

AM IL-1 production

IL-1 production

IL-1 production

IL-1 production

LPS concentration

optimal LPS concentration

low LPS concentration

respiratory tract infection

healthy

Twelve

nonsmoking healthy

respiratory tract infection


Direct and indirect effects of interdental hygiene in a clinical trial . Many randomized controlled trials ( RCTs ) in dental research test the efficacy of interventions on more than one outcome variable . Univariate methods , such as the t test or analysis of covariance , can not evaluate the efficacy of interventions on multiple outcomes simultaneously . The aim of this study was to use structural equation modeling ( SEM ) to re-analyze a RCT , comparing the effects of pre-curved interdental brushes and flossing on probing pocket depth ( PPD ) , plaque indices , and bleeding on probing ( BOP ) measured at baseline , intermediate , and final examinations . Results of SEM showed that the observed greater reduction in PPD and BOP in persons using interdental brushing than in those flossing is due mainly to the greater efficiency in plaque removal with the interdental brushes ( indirect effect ) rather than to the compression of the interdental papillae ( direct effect ) . In contrast , smokers showed less BOP at baseline but also less improvement in BOP through direct effects .

interdental hygiene

structural equation modeling

PPD

BOP

efficiency in plaque removal

BOP

BOP

smokers


Need the thumb be immobilised in scaphoid fractures ? A randomised prospective trial . Immobilisation of the thumb is widely believed to be important in the management of fractures of the carpal scaphoid . To assess the need for this , we randomly allocated 392 fresh fractures for treatment by either a forearm gauntlet ( Colles ' ) cast , leaving the thumb free , or by a conventional 'scaphoid ' plaster incorporating the thumb as far as its interphalangeal joint . In the 292 fractures which were followed for six months , the incidence of nonunion was independent of the type of cast used .

thumb be immobilised

Immobilisation of the thumb

forearm gauntlet ( Colles ' ) cast

incidence of nonunion

scaphoid fractures

fractures of the carpal scaphoid


Two large preoperative doses of erythropoietin do not reduce the systemic inflammatory response to cardiac surgery . OBJECTIVES Cardiac surgery and cardiopulmonary bypass ( CPB ) induce an inflammatory reaction that may lead to tissue injury . Experimental studies suggest that recombinant human erythropoietin ( EPO ) independent of its erythropoietic effect may be used clinically as an anti-inflammatory drug . This study tested the hypothesis that 2 large doses of EPO administered shortly before CPB ameliorate the systemic inflammatory response to CPB . DESIGN AND SETTING A prospective , double-blind , placebo-controlled and randomized study at a single tertiary care hospital . PARTICIPANTS Patients scheduled for coronary artery bypass graft surgery with CPB . INTERVENTIONS EPO ( epoetin alfa , 500 IU/kg intravenously , n = 22 ) or placebo ( n = 21 ) was administered 12 to 18 hours preoperatively and again at the induction of anesthesia . MEASUREMENTS AND MAIN RESULTS CPB in both groups greatly increased plasma concentrations of tumor necrosis factor alpha ( TNF-alpha ) , interleukin ( IL ) -1beta , IL-1beta receptor antagonist , IL-6 , IL-10 , and N-terminal probrain natriuretic peptide ( NT-proBNP ) . Compared with placebo , EPO at day 3 after CPB augmented the TNF-alpha response ( p < 0.05 ) and at 2 hours after CPB increased NT-proBNP ( p < 0.05 ) . Also , EPO tended to enhance the CPB-induced increase in IL-1beta receptor antagonist ( p = 0.057 ) . Otherwise , EPO had no effect on pro- and antiinflammatory mediators compared with placebo . CONCLUSIONS Two large doses of EPO given shortly before CPB do not reduce perioperative release of inflammatory cytokines . In contrast , EPO may augment the TNF-alpha and NT-proBNP response . Although the long-term clinical impact remains unknown , the findings do not support use of EPO as an anti-inflammatory drug in patients undergoing cardiac surgery .

erythropoietin

EPO

placebo-controlled

EPO ( epoetin alfa

placebo

placebo , EPO

EPO

EPO

EPO

EPO

EPO

interleukin ( IL ) -1beta

IL-1beta receptor antagonist , IL-6

TNF-alpha response

IL-1beta receptor antagonist

pro- and antiinflammatory mediators


Is adjuvant chemotherapy of benefit for postmenopausal women who receive endocrine treatment for highly endocrine-responsive , node-positive breast cancer ? International Breast Cancer Study Group Trials VII and 12-93 . To compare the efficacy of chemoendocrine treatment with that of endocrine treatment ( ET ) alone for postmenopausal women with highly endocrine responsive breast cancer . In the International Breast Cancer Study Group ( IBCSG ) Trials VII and 12-93 , postmenopausal women with node-positive , estrogen receptor ( ER ) -positive or ER-negative , operable breast cancer were randomized to receive either chemotherapy or endocrine therapy or combined chemoendocrine treatment . Results were analyzed overall in the cohort of 893 patients with endocrine-responsive disease , and according to prospectively defined categories of ER , age and nodal status . STEPP analyses assessed chemotherapy effect . The median follow-up was 13 years . Adding chemotherapy reduced the relative risk of a disease-free survival event by 19 % ( P = 0.02 ) compared with ET alone . STEPP analyses showed little effect of chemotherapy for tumors with high levels of ER expression ( P = 0.07 ) , or for the cohort with one positive node ( P = 0.03 ) . Chemotherapy significantly improves disease-free survival for postmenopausal women with endocrine-responsive breast cancer , but the magnitude of the effect is substantially attenuated if ER levels are high .

adjuvant chemotherapy

chemoendocrine treatment

endocrine treatment ( ET )

chemotherapy

endocrine therapy

combined chemoendocrine treatment

chemotherapy

ET

Chemotherapy

efficacy

levels of ER expression

disease-free survival

for

postmenopausal

women

breast cancer

Breast Cancer

postmenopausal

women

breast cancer

postmenopausal

women

breast cancer

endocrine-responsive disease

postmenopausal

women

breast cancer


Impact of isotonic and hypertonic saline solutions on mucociliary activity in various nasal pathologies : clinical study . OBJECTIVE To investigate the impact of nasal irrigation with isotonic or hypertonic sodium chloride solution on mucociliary clearance time in patients with allergic rhinitis , acute sinusitis and chronic sinusitis . PATIENTS AND METHODS Mucociliary clearance time was measured using the saccharine clearance test on 132 adults before and after 10 days ' application of intranasal isotonic or hypertonic saline . Patient numbers were as follows : controls , 45 ; allergic rhinitis , 21 ; acute sinusitis , 24 ; and chronic sinusitis , 42 . The results before and after irrigation were compared using the Wilcoxon t-test . RESULTS Before application of saline solutions , mucociliary clearance times in the three patient treatment groups were found to be significantly delayed , compared with the control group . Irrigation with hypertonic saline restored impaired mucociliary clearance in chronic sinusitis patients ( p < 0.05 ) , while isotonic saline improved mucociliary clearance times significantly in allergic rhinitis and acute sinusitis patients ( p < 0.05 ) . CONCLUSION Nasal irrigation with isotonic or hypertonic saline can improve mucociliary clearance time in various nasal pathologies . However , these solutions should be selectively prescribed rather than used based on anecdotal evidence . Further studies should be conducted to develop a protocol for standardised use of saline solution irrigation in various nasal pathologies .

isotonic

hypertonic saline solutions

isotonic

hypertonic sodium chloride solution

application of intranasal isotonic

hypertonic saline

saline solutions

hypertonic saline

isotonic saline

isotonic

hypertonic saline

saline solution irrigation

mucociliary clearance times

mucociliary clearance time

nasal pathologies

allergic rhinitis

acute sinusitis

chronic sinusitis

adults

controls , 45

allergic rhinitis , 21

acute sinusitis , 24

chronic sinusitis , 42


Treatment with the dipeptidyl peptidase-4 inhibitor vildagliptin improves fasting islet-cell function in subjects with type 2 diabetes . CONTEXT Dipeptidyl peptidase 4 ( DPP-4 ) inhibitors are proposed to lower blood glucose in type 2 diabetes mellitus ( T2DM ) by prolonging the activity of the circulating incretins , glucose-dependent insulinotropic polypeptide ( GIP ) and glucagon-like peptide 1 ( GLP-1 ) . Consistent with this mechanism of action , DPP-4 inhibitors improve glucose tolerance after meals by increasing insulin and reducing glucagon levels in the plasma . However , DPP-4 inhibitors also reduce fasting blood glucose , an unexpected effect because circulating levels of active GIP and GLP-1 are low in the postabsorptive state . OBJECTIVE The objective of the study was to examine the effects of DPP-4 inhibition on fasting islet function . DESIGN We conducted a randomized , double-blind , placebo-controlled trial . SETTING The study was performed in General Clinical Research Centers at two University Hospitals . SUBJECTS Forty-one subjects with T2DM were treated with metformin or diet , having good glycemic control with glycosylated hemoglobin values of 6.2-7.5 % . INTERVENTION Subjects were treated with vildagliptin ( 50 mg twice daily ) or placebo for 3 months , followed by a 2-wk washout . Major Outcome Measure : We measured insulin secretion in response to iv glucose and arginine before and after treatment and after drug washout . RESULTS There were small and comparable reductions in glycosylated hemoglobin in both groups over 3 months . Vildagliptin increased fasting GLP-1 levels in subjects taking metformin , but not those managed with diet , and raised active GIP levels slightly . DPP-4 inhibitor treatment improved the acute insulin and C-peptide responses to glucose ( 50 and 100 % respectively ; P < 0.05 ) and increased the slope of the C-peptide response to glucose ( 33 % ; P = 0.023 ) . CONCLUSION Vildagliptin improves islet function in T2DM under fasting conditions . This suggests that DPP-4 inhibition has metabolic benefits in addition to enhancing meal-induced GLP-1 and GIP activity .

DPP-4 inhibitors

DPP-4 inhibitors

placebo-controlled

metformin

vildagliptin

placebo

metformin

DPP-4 inhibitor

Vildagliptin

glycosylated hemoglobin

acute insulin and C-peptide responses

C-peptide response


Hyperinsulinemia fails to augment ET-1 action in the skeletal muscle vascular bed in vivo in humans . Endogenous endothelin action is augmented in human obesity and type 2 diabetes and contributes to endothelial dysfunction and impairs insulin-mediated vasodilation in humans . We hypothesized that insulin resistance-associated hyperinsulinemia could preferentially drive endothelin-mediated vasoconstriction . We applied hyperinsulinemic-euglycemic clamps with higher insulin dosing in obese subjects than lean subjects ( 30 vs. 10 mU.m ( -2 ) .min ( -1 ) , respectively ) , with the goal of matching insulin 's nitric oxide ( NO ) -mediated vascular effects . We predicted that , under these circumstances , insulin-stimulated endothelin-1 ( ET-1 ) action ( assessed with the type A endothelin receptor antagonist BQ-123 ) would be augmented in proportion to hyperinsulinemia . NO bioactivity was assessed using the nitric oxide synthase inhibitor N ( G ) -monomethyl-l-arginine . Insulin-mediated vasodilation and insulin-stimulated NO bioavailability were well matched across groups by this approach . As expected , steady-state insulin levels were approximately threefold higher in obese than lean subjects ( 109.2 +/- 10.2 pmol/l vs. 518.4 +/- 84.0 , P = 0.03 ) . Despite this , the augmentation of insulin-mediated vasodilation by BQ-123 was not different between groups . ET-1 flux across the leg was not augmented by insulin alone but was increased with the addition of BQ-123 to insulin ( P = 0.01 BQ-123 effect , P = not significant comparing groups ) . Endothelin antagonism augmented insulin-stimulated NO bioavailability and NOx flux , but not differently between groups and not proportional to hyperinsulinemia . These findings do not support the hypothesis that insulin resistance-associated hyperinsulinemia preferentially drives endothelin-mediated vasoconstriction .

hyperinsulinemic-euglycemic clamps

insulin

Insulin-mediated

endothelin-mediated vasoconstriction

NO bioactivity

Insulin-mediated vasodilation

insulin-stimulated NO bioavailability

steady-state insulin levels

insulin-mediated vasodilation

ET-1 flux

insulin-stimulated NO bioavailability

NOx flux

endothelin-mediated vasoconstriction

obese subjects

lean subjects


Consumer-directed care for beneficiaries with mental illness : lessons from New Jersey 's Cash and Counseling program . OBJECTIVE Previous research from the Cash and Counseling Demonstration and Evaluation ( CCDE ) programs in New Jersey , Arkansas , and Florida suggests that consumers ' control over personal care greatly improves their satisfaction with care arrangements and their outlook on life . Still , some argue that consumer-directed care may not be appropriate for consumers with a diagnosis of mental illness . This study examined the effectiveness of the CCDE program for those with a diagnosis of mental illness . METHODS This study examined nonelderly Medicaid beneficiaries in New Jersey with a diagnosis of mental illness and compared and contrasted the experiences of those in New Jersey 's CCDE program ( N=109 ) and those who received services provided by an agency ( N=119 ) . Logistic regression analyses were performed on baseline and nine-month follow-up data . RESULTS By examining outcome measures -- including satisfaction with care arrangements , consumers ' perceptions of paid caregivers ' attitudes , unmet needs , adverse events , and satisfaction with life -- this study offers evidence that , from the perspective of consumers , the CCDE program is appropriate for participants with a mental illness diagnosis . For most outcome measures the CCDE program demonstrated a positive effect after baseline characteristics were controlled for . The analysis of measures of adverse events , health problems , and general health status did not yield statistically significant differences between the control group and the treatment group , indicating that CCDE care was at least as safe as agency-directed care . CONCLUSIONS Considering the growing need for long-term care services and the limited resources available , a consumer-directed option can be a valuable alternative for persons with a diagnosis of mental illness .

care arrangements

outlook on life .

effectiveness of the CCDE program

Logistic regression analyses

satisfaction with care arrangements

adverse events

satisfaction with life

positive effect

adverse events

beneficiaries with mental illness :


[ Effects of small needle-knife comprehensive therapy on pain and lumbar flexion range in the chronic nonspecific low back pain patient ] . OBJECTIVE To observe therapeutic effect of small needle-knife comprehensive therapy on pain and lumbar flexion range in the chronic nonspecific low back pain patient . METHODS Three hundred and five cases were randomly divided into a needle-knife group of 153 cases and a physiotherapy group of 152 cases . The needle-knife group were treated with small needle-knife releasing therapy , blocking and functional training . The physiotherapy group were treated with ultra-short wave , modulated medium frequency current , massage and functional training . Pain was assessed by visual analogue scale ( VAS ) and the lumbar flexion range was determined before and after treatment . RESULTS After treatment , the pain and the lumbar flexion range were significantly improved in the two groups ; and after treatment , the VAS score and the lumbar flexion range were ( 1.60 +/- 0.38 ) points and ( 65.76 +/- 15.11 ) cm in the needle-knife group and ( 4.59 +/- 1.09 ) points and ( 53.74 +/- 15.13 ) cm in the physiotherapy group , respectively , the needle-knife group being significantly better than the physiotherapy group ( P < 0.01 ) . Follow-up survey of 6-36 months showed that the VAS score and the lumbar flexion range in the needle-knife group were superior to those in the physiotherapy group . CONCLUSION Small needle-knife comprehensive therapy can significantly improve pain and lumbar flexion range in the chronic nonspecific low back pain patient , with a stable long-term therapeutic effect .

needle-knife

physiotherapy

needle-knife

needle-knife

blocking and functional training

physiotherapy

ultra-short wave

modulated medium frequency current

massage and functional training

needle-knife

needle-knife

physiotherapy

pain

lumbar flexion range

Pain

visual analogue scale ( VAS

lumbar flexion range

pain

lumbar flexion range

VAS score

lumbar flexion range

VAS score

lumbar flexion range

pain

lumbar flexion range

chronic nonspecific low back pain

chronic nonspecific low back pain

Three hundred and five

chronic nonspecific low back pain


Comparison of 40 milliliters of 0.25 % intrapleural bupivacaine with epinephrine with 20 milliliters of 0.5 % intrapleural bupivacaine with epinephrine after cholecystectomy . To determine the influence of the volume of local anesthetic injected for intrapleural analgesia , 40 patients undergoing cholecystectomy were randomly allocated to two groups of 20 patients each . One group received 40 mL of 0.25 % bupivacaine with epinephrine injected intrapleurally postoperatively . The other group received 20 mL of 0.5 % bupivacaine with epinephrine . The onset time of analgesia was nearly the same in both groups and within 25 min all patients were nearly pain free . Our data demonstrate that 100 mg of bupivacaine with epinephrine elicits effective analgesia after cholecystectomy . There are only minor differences between 20 and 40 mL with regard to pain relief . The authors conclude that the volume of local anesthetic within the range of 20-40 mL in an adult has little influence on the extent or duration of intrapleural analgesia .

bupivacaine

epinephrine

bupivacaine with epinephrine

bupivacaine with epinephrine

onset time of analgesia

pain relief .


Can HMG Co-A reductase inhibitors ( " statins " ) slow the progression of age-related macular degeneration ? The age-related maculopathy statin study ( ARMSS ) . Age-related macular degeneration ( AMD ) is responsible for the majority of visual impairment in the Western world . The role of cholesterol-lowering medications , HMG Co-A reductase inhibitors or statins , in reducing the risk of AMD or of delaying its progression has not been fully investigated . A 3-year prospective randomized controlled trial of 40 mg simvastatin per day compared to placebo in subjects at high risk of AMD progression is described . This paper outlines the primary aims of the Age-Related Maculopathy Statin Study ( ARMSS ) , and the methodology involved . Standardized clinical grading of macular photographs and comparison of serial macular digital photographs , using the International grading scheme , form the basis for assessment of primary study outcomes . In addition , macular function is assessed at each visit with detailed psychophysical measurements of rod and cone function . Information collected in this study will assist in the assessment of the potential value of HMG Co-A reductase inhibitors ( statins ) in reducing the risk of AMD progression .

40 mg simvastatin per day

placebo

age-related macular degeneration

AMD


Two-year prospective clinical comparison of immediate replacement vs. immediate restoration of single tooth in the esthetic zone . AIM To compare the immediate restoration of single implants in the esthetic zones performed on implants placed immediately after tooth extraction or 8 weeks later ( immediate replacement vs. immediate restoration ) . METHODS Sixteen patients ( 10 women and 6 men ) with a mean age of 35 years ( ranging from 21 to 49 years old ) were treated from 2004 to 2005 for single-tooth replacement in the upper arch . The patients were randomly divided into two groups : in the test group patients received implants placed and restored ( non-occlusal loading ) at the time of tooth extraction ; in the control group implants were placed 8 weeks after tooth extraction and immediately restored . All the patients received tapered effect ( TE ) implants from the Straumann Dental Implant System . The following parameters were evaluated at the moment of provisional restoration ( within 48 h after implant placement ) and at the 2 years follow-up visit : marginal bone resorption , papilla index , position of the mucosal margin . The implant stability quotient was measured at the moment of implant placement and at the moment of the delivery of the definitive restoration . RESULTS No statistically significant differences were found in any of the studied parameters between the test and the control groups ( P > 0.05 ) . The implant stability quotient values between the test and control groups were significant ( P < 0.05 ) at the moment of implant placement but were no more significant at the loading of the definitive restoration ( P > 0.05 ) . CONCLUSION The results of the present study suggest that immediate replacement without functional loading may be considered a valuable therapeutic option for selected cases of single-tooth replacement in the esthetic area when TE implants are used . Implant stability at the moment of implant placement is slightly inferior in the immediate replacement group , but it does not affect the treatment result .

single implants

replacement

restoration )

implants placed and restored

implants were placed

tapered effect ( TE ) implants

single-tooth replacement

implant stability quotient

implant stability quotient values

Implant stability

single tooth

esthetic zone

Sixteen

tapered effect ( TE ) implants

Straumann Dental Implant System


Comparison between intermittent mandatory ventilation and synchronized intermittent mandatory ventilation with pressure support in children . OBJECTIVE To compare intermittent mandatory ventilation ( IMV ) with synchronized intermittent mandatory ventilation plus pressure support ( SIMV+PS ) in terms of time on mechanical ventilation , duration of weaning and length of stay in a pediatric intensive care unit ( PICU ) . METHODS This was a randomized clinical trial that enrolled children aged 28 days to 4 years who were admitted to a PICU between October of 2005 and June of 2007 and put on mechanical ventilation ( MV ) for more than 48 hours . These patients were allocated to one of two groups by drawing lots : IMV group ( IMVG ; n = 35 ) and SIMV+PS group ( SIMVG ; n = 35 ) . Children were excluded if they had undergone tracheotomy or had chronic respiratory diseases . Data on oxygenation and ventilation were recorded at admission and at the start of weaning . RESULTS There were no statistical differences between the groups in terms of age , sex , indication for MV , PRISM score , Comfort scale , use of sedatives or ventilation and oxygenation parameters . The median time on MV was 5 days for both groups ( p = 0.120 ) . There were also no statistical differences between the two groups for duration of weaning [ IMVG : 1 day ( 1-6 ) vs. SIMVG : 1 day ( 1-6 ) ; p = 0.262 ] or length of hospital stay [ IMVG : 8 days ( 2-22 ) vs. SIMVG : 6 days ( 3-20 ) ; p = 0.113 ] . CONCLUSION Among the children studied here , there was no statistically significant difference between IMV and SIMV+PS in terms of time on MV , duration of weaning or time spent in the PICU . ClinicalTrials.govID : NCT00549809 .

intermittent mandatory ventilation

pressure support

mechanical ventilation ( MV )

IMV

( IMVG

SIMV+PS

SIMVG

IMVG

SIMVG

IMVG

SIMVG

IMV

SIMV+PS

time on mechanical ventilation

oxygenation

and

ventilation

median time on MV

duration of weaning

length of hospital stay

children

children aged 28 days to 4 years

PICU

Children

chronic respiratory diseases .

children


A controlled study of the effect of cognitive-behavioural group therapy for pathological gamblers . As the number of pathological gamblers has increased recently , the need for effective treatment has become more evident . The aim of this study was to evaluate the effectiveness of a short-term cognitive-behavioural group therapy programme for pathological gamblers . Fourteen subjects ( three females and 11 males ) , who met the criteria for pathological gambling in accordance with the Diagnostic and Statistical Manual of Mental Disorders IV , were randomly assigned to a Treatment Group ( n=7 ) or a waiting list Control Group ( n=7 ) . An experimental design with three repeated measures was used ( pre-treatment , post-treatment/post-waiting list and follow-up ) . The dependent variables were DSM-IV Criteria for Pathological Gambling , Money Spent on Gambling During the Last Week and Gamblers Inventory of Negative Consequences . The Treatment Group improved on the DSM-IV Criteria for Pathological Gambling , but did not show a significant improvement on Money Spent on Gambling During the Last week from pre-treatment to post-treatment . Combining both groups at 3-months follow-up , there was a significant improvement on all three variables from pre-treatment to follow-up . The results of this controlled study indicate that a short-term cognitive-behavioural group treatment for pathological gamblers had an effect .

cognitive-behavioural group therapy

Treatment Group ( n=7 )

waiting list Control Group ( n=7 ) .

pathological gamblers .

pathological gamblers

pathological gamblers


Evaluating online continuing medical education seminars : evidence for improving clinical practices . The purpose of this study was to evaluate the potential for online continuing medical education ( CME ) seminars to improve quality of care . Primary care physicians ( 113 ) participated in a randomized controlled trial to evaluate an online CME series . Physicians were randomized to view either a seminar about type 2 diabetes or a seminar about systolic heart failure . Following the seminar , physicians were presented with 4 clinical vignettes and asked to describe what tests , treatments , counseling , or referrals they would recommend . Physicians who viewed the seminars were significantly more likely to recommend guideline-consistent care to patients in the vignettes . For example , physicians who viewed the diabetes seminar were significantly more likely to order an eye exam for diabetes patients ( 63 % ) compared with physicians in the control group ( 27 % ) . For some guidelines there were no group differences . These results provide early evidence of the effectiveness of online CME programs to improve physician clinical practice .

seminar about type 2 diabetes

seminar about systolic heart failure

seminar

online CME programs

improve quality of care .

recommend guideline-consistent care

order an eye exam for diabetes patients

improve physician clinical practice .

physicians


Phosphate binder impact on bone remodeling and coronary calcification -- results from the BRiC study . BACKGROUND AND AIMS Calcium-containing phosphate binders have been shown to increase the progression of vascular calcification in hemodialysis patients . This is a prospective study that compares the effects of calcium acetate and sevelamer on coronary calcification ( CAC ) and bone histology . METHODS 101 hemodialysis patients were randomized for each phosphate binder and submitted to multislice coronary tomographies and bone biopsies at entry and 12 months . RESULTS The 71 patients who concluded the study had similar baseline characteristics . On follow-up , the sevelamer group had higher levels of intact parathyroid hormone ( 498 +/- 352 vs. 326 +/- 236 pg/ml , p = 0.017 ) , bone alkaline phosphatase ( 38 +/- 24 vs. 28 +/- 15 U/l , p = 0.03 ) and deoxypyridinoline ( 135 +/- 107 vs. 89 +/- 71 nmol/l , p = 0.03 ) and lower LDL cholesterol ( 74 +/- 21 vs. 91 +/- 28 mg/dl , p = 0.015 ) . Phosphorus ( 5.8 +/- 1.0 vs. 6 +/- 1.0 mg/dl , p = 0.47 ) and calcium ( 1.27 +/- 0.07 vs. 1.23 +/- 0.08 mmol/l , p = 0.68 ) levels did not differ between groups . CAC progression ( 35 vs. 24 % , p = 0.94 ) and bone histological diagnosis at baseline and 12 months were similar in both groups . Patients of the sevelamer group with a high turnover at baseline had an increase in bone resorption ( eroded surface , ES/BS = 9.0 +/- 5.9 vs. 13.1 +/- 9.5 % , p = 0.05 ) , whereas patients of both groups with low turnover at baseline had an improvement in bone formation rate ( BFR/BS = 0.015 +/- 0.016 vs. 0.062 +/- 0.078 , p = 0.003 for calcium and 0.017 +/- 0.016 vs. 0.071 +/- 0.084 microm ( 3 ) /microm ( 2 ) /day , p = 0.010 for sevelamer ) . CONCLUSIONS There was no difference in CAC progression or changes in bone remodeling between the calcium and the sevelamer groups .

Phosphate binder

Calcium-containing phosphate binders

calcium acetate and sevelamer

phosphate binder

bone remodeling

coronary calcification

vascular calcification

coronary calcification

bone histology

intact parathyroid hormone

bone alkaline phosphatase

deoxypyridinoline

LDL cholesterol

Phosphorus

calcium

CAC progression

bone histological diagnosis

bone resorption

bone formation rate

CAC progression

bone remodeling

hemodialysis

hemodialysis