Preoperative beta-blocker usage : is it really worthy of being a quality indicator ? BACKGROUND Since 2007 , the use of preoperative β-blockers has been used as a quality standard for patients undergoing coronary artery bypass graft surgery . Recent studies have called into question of the benefit of empiric preoperative β-blocker use . METHODS Data were extracted from our Society of Thoracic Surgeons certified database for patients undergoing isolated coronary artery bypass graft surgery from 2000 to 2008 . We compared the outcomes for patients who received preoperative β-blockers with those of patients who did not . RESULTS The study group had 12,855 patients , of whom 7,967 ( 62.0 % ) were treated preoperatively with β-blockers . Using propensity matching , we selected two matched groups of 4,474 patients with preoperative β-blocker use and 4,474 not using preoperative β-blockers . In the unmatched cohort , only deep sternal infection ( 0.3 % versus 0.5 % without β-blockers ; p=0.032 ) , pneumonia ( 1.9 % versus 2.4 % without β-blockers ; p=0.039 ) , and intraoperative blood usage ( 37.2 % versus 34.1 % without β-blockers ; p < 0.001 ) reached statistically significant difference . In the matched groups , there was no difference between adverse event rates in patients treated with β-blockers and those who were not . The number of patients requiring intraoperative blood product use was significantly higher among β-blocker-treated patients ( p=0.004 ) . Calculating the adjusted odds ratios showed that in the matched groups , the preoperative use of β-blockers was not an independent predictor of mortality . CONCLUSIONS A rational for preoperative β-blockade exists . However , as with any medical intervention , its application should be tailored to specific clinical scenarios . With no differences in mortality or morbidity , our findings do not support preoperative β-blockade as a useful quality indicator for coronary artery bypass graft surgery .

beta-blocker usage

deep sternal infection

pneumonia

intraoperative blood

adverse event

requiring intraoperative blood product


Adjusting intraocular pressure for central corneal thickness does not improve prediction models for primary open-angle glaucoma . PURPOSE To determine if the accuracy of the baseline prediction model for the development of primary open-angle glaucoma ( POAG ) in patients with ocular hypertension can be improved by correcting intraocular pressure ( IOP ) for central corneal thickness ( CCT ) . DESIGN Reanalysis of the baseline prediction model for the development of POAG from the Ocular Hypertension Treatment Study ( OHTS ) substituting IOP adjusted for CCT using 5 different correction formulae for unadjusted IOP . PARTICIPANTS A total of 1433 of 1636 participants randomized to OHTS who had complete baseline data for factors in the prediction model : age , IOP , CCT , vertical cup-to-disc ratio ( VCDR ) , and pattern standard deviation ( PSD ) . METHODS Reanalysis of the prediction model for the risk of developing POAG using the same baseline variables ( age , IOP , CCT , VCDR , and PSD ) except that IOP was adjusted for CCT using correction formulae . A separate Cox proportional hazards model was run using IOP adjusted for CCT by each of the 5 formulae published to date . Models were run including and excluding CCT . MAIN OUTCOME MEASURES Predictive accuracy of each Cox proportional hazards model was assessed using the c-statistic and calibration chi-square . RESULTS C-statistics for prediction models that used IOP adjusted for CCT by various formulas ranged from 0.75 to 0.77 , no better than the original prediction model ( 0.77 ) that did not adjust IOP for CCT . Calibration chi-square was acceptable for all models . Baseline IOP , whether adjusted for CCT or not , was statistically significant in all models including those with CCT in the same model . The CCT was statistically significant in all models including those with IOP adjusted for CCT in the same model . CONCLUSIONS The calculation of individual risk for developing POAG in ocular hypertensive individuals is simpler and equally accurate using IOP and CCT as measured , rather than applying an adjustment formula to correct IOP for CCT .

baseline prediction model

prediction

Baseline IOP

CCT

ocular hypertension

OHTS

ocular hypertensive


Pharmacodynamic effects on biochemical markers of bone turnover and pharmacokinetics of the cathepsin K inhibitor , ONO-5334 , in an ascending multiple-dose , phase 1 study . Selective inhibitors of cathepsin K , which has a major role in the degradation of bone collagen , are potential new treatments for osteoporosis . The pharmacokinetics and the pharmacodynamic effects on biochemical markers of bone turnover of the new cathepsin K inhibitor , ONO-5334 , were investigated in a multiple ascending dose , phase 1 study . A total of 120 healthy postmenopausal women were enrolled , and doses of 10 to 600 mg once daily and 50 and 300 mg twice daily were evaluated in 15- and 28-day multiple-dosing cohorts . Plasma ONO-5334 concentration reached steady state within 2 days . Twenty-four hours after the last dose in the 15-day multiple-dose cohort , 100 , 300 , and 600 mg once daily reduced urinary C-terminal telopeptide of type I collagen by a mean ( ± standard deviation ) 44.9 % ± 13.6 % , 84.5 % ± 4.4 % , and 92.5 % ± 1.3 % , respectively . The 28-day cohort showed similar effects . There were far smaller effects on bone-specific alkaline phosphatase ( B-ALP ) , tartrate-resistant acid phosphatase 5b ( TRAP5b ) , or osteocalcin ( OC ) ( measured after 28 days ) . ONO-5334 was well tolerated up to 600 mg/d and for up to 28 days of multiple dosing . Multiple dosing with ONO-5334 100 mg resulted in considerable suppression of bone resorption markers with no appreciable effects on bone formation markers ( B-ALP , OC ) or osteoclast number ( TRAP5b ) .

cathepsin K inhibitor , ONO-5334

cathepsin K inhibitor , ONO-5334

biochemical markers of bone turnover

pharmacokinetics

postmenopausal

women


Beverage vs. solid fruits and vegetables : effects on energy intake and body weight . Beverage consumption has been implicated in weight gain , but questions remain about the veracity of the association , whether the relationship is causal and what property of beverages is responsible . It was hypothesized that food form is the most salient attribute . Thus , a randomized controlled trial of food form was conducted . Energy-matched beverage or solid forms of fruits and vegetables were provided to 34 , lean or overweight/obese adults for two 8-week periods with a 3-week washout interspersed . Dietary compensation was incomplete ( beverage 53 % ; solid 78 % ) and body weight increased after the beverage ( 1.95 ± 0.33 kg ) ( 77 % fat mass ) and solid ( 1.36 ± 0.30 kg ) ( 85 % fat mass ) treatments ( both P < 0.0005 ) . Differences between food forms were not significant . The lean group had the highest dietary compensation ( 119 % ) and no significant weight change ( 0.84 ± 0.53 kg ) after consuming the solid fruits and vegetables whereas the overweight/obese group had lower compensation and significant weight gain during the solid arm ( 46 % , 1.77 ± 0.32 kg , P < 0.0001 ) . In contrast , incomplete dietary compensation and weight gain occurred in both the lean ( 43 % , 1.61 ± 0.44 kg , P = 0.003 ) and overweight/obese ( 61 % , 2.22 ± 0.47 kg , P < 0.0005 ) groups during the beverage arm . Secondary analyses revealed the obese group gained more weight than the lean and overweight groups during the beverage intervention ( P = 0.024 ) . These data demonstrate energy consumed as beverages may be especially problematic for weight gain . They also indicate that advice to increase fruit and vegetable consumption should emphasize total energy intake because the additional energy contributed may promote weight gain , especially among overweight and obese individuals .

Beverage

vs.

solid fruits and vegetables

Energy-matched beverage

or

solid forms of fruits and vegetables

body weight .

Dietary compensation

body weight

lean or overweight/obese

adults


Cross-modal attention-switching is impaired in autism spectrum disorders . This investigation aimed to determine if children with ASD are impaired in their ability to switch attention between different tasks , and whether performance is further impaired when required to switch across two separate modalities ( visual and auditory ) . Eighteen children with ASD ( 9-13 years old ) were compared with 18 typically-developing children matched with the ASD group for mental age , and also with 18 subjects with learning difficulties matched with the ASD group for mental and chronological age . Individuals alternated between two different visual tasks , and between a different visual task and an auditory task . Children with ASD performed worse than both comparison groups at both switching tasks . Moreover , children with ASD had greater difficulty when different modalities were required than where only one modality was required in the switching task in comparison with participants matched in terms of mental and chronological age .

two different visual tasks

between a

performed worse

switching tasks .

ASD

Eighteen

children

ASD

( 9-13 years old )

children


Validity and reliability assessment of the Siriraj Asthma Control Questionnaire . OBJECTIVE The present study assessed the validity and reliability of the Siriraj Asthma Control Questionnaire in Asthma Clinic , Siriraj Hospital . MATERIAL AND METHOD The data of the questionnaire responses and spirometric results from 20 randomized asthmatic patients in the clinic including the record of 3 visits for each subject . The validation was performed by Kruskal-Wallis test comparing the scores with the level of asthma control determined by physicians according to GINA guideline . Internal consistency reliability was analyzed by Cronbach 's alpha . RESULTS Sixty questionnaires from 20 patients with age 29-73 years were analyzed . There were 40 controlled , 7 partly controlled and 13 uncontrolled visits . The scores from 5-items questionnaires and 6-items clinical score were significantly associated with the physician-diagnosed groups ( i.e. , controlled , partly controlled and uncontrolled groups ) . Median scores ( min , max ) were 0 ( 0 , 5 ) , 2 ( 0 , 6 ) , 4 ( 0 , 12 ) respectively , ( 5-items , p < 0.001 ) and 2 ( 0 , 7 ) , 3 ( 1 , 7 ) , 6 ( 2,15 ) respectively , ( 6-items , p < 0.001 ) . Internal consistency reliability of both 5-items questionnaire and 6-items clinical score were within the acceptable range ( 0.829 and 0.708 respectively ) . 5-items questionnaire is more associated with the physician diagnosed group and more consistent than 6-items clinical score . Further analysis revealed cutoff point at 2.5 to separate uncontrolled from controlled or partly controlled patient with sensitivity 76.9 % and specificity 89.4 % and cutoff point at 1.5 to separate uncontrolled or partly controlled from controlled patient with sensitivity 70.0 % and specificity 85.0 % . CONCLUSION The validity and reliability of Siriraj Asthma Control Questionnaire is acceptable and might be used in the clinical practice and research in Thai asthmatic patients .

Siriraj Asthma Control Questionnaire

Siriraj Asthma Control Questionnaire

Kruskal-Wallis test

Siriraj Asthma Control Questionnaire

Validity and reliability

validity

reliability

Median scores ( min , max )

Internal consistency reliability

5-items questionnaire

consistent

6-items clinical score .

sensitivity

specificity

cutoff point

sensitivity

specificity

validity and reliability

Asthma

asthmatic

age 29-73 years

asthmatic


Nepafenac for epiretinal membrane surgery .

Nepafenac

epiretinal membrane surgery .


The IDvIP trial : a two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia . BACKGROUND Intramuscular pethidine is routinely used throughout the UK for labour analgesia . Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate . It can cause nausea , vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations . Neonatal effects include respiratory depression and impaired feeding . There are few large studies comparing the relative side effects and efficacy of different opioids in labour . A small trial comparing intramuscular pethidine with diamorphine , showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid . METHODS The Intramuscular Diamorphine versus Intramuscular Pethidine ( IDvIP ) trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother , fetus and neonate . Information about the trial will be provided to women in the antenatal period or in early labour . Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia . The sample size requirement is 406 women with data on primary outcomes . The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes . The neonatal primary outcomes are need for resuscitation and Apgar Score < 7 at 1 minute . The secondary outcomes are an additional measure of pain relief , maternal sedation , nausea and vomiting , maternal oxygen saturation , satisfaction with analgesia , whether method of analgesia would be used again , use of Entonox , umbilical arterial and venous pH , fetal heart rate , meconium staining , time from delivery to first breath , Apgar scores at 5 mins , naloxone requirement , transfer to neonatal intensive care unit , neonatal haemoglobin oxygen saturation at 30 , 60 , 90 , and 120 mins after delivery , and neonatal sedation and feeding behaviour during first 2 hours . DISCUSSION If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour . TRIAL REGISTRATION ISRCTN14898678Eudra No : 2006-003250-18 , REC Reference No : 06/Q1702/95 , MHRA Authorisation No : 1443/0001/001-0001 , NIHR UKCRN reference 6895 , RfPB grant PB-PG-0407-13170_IR5 .

diamorphine

pethidine

pethidine

pethidine

pethidine

diamorphine

diamorphine

pethidine

Diamorphine

Pethidine

diamorphine

pethidine

diamorphine

diamorphine

opioid

pain relief after 60 minutes .


Influence of chestnut tannins on welfare , carcass characteristics , meat quality , and lipid oxidation in rabbits under high ambient temperature . A study was conducted to evaluate the influence of chestnut tannins ( CT ) on welfare , carcass characteristics , meat quality , and lipid oxidation in rabbits under high ambient temperature . Rabbits in one group were raised at 20°C and fed with basal diet ( N ) and other three groups ( 33°C ) were fed basal diet with 0 ( C ) , 5 ( CT5 ) , and 10 g ( CT10 ) of CT/kg of diet . Compared with the C group , rabbits in CT10 had higher pH ( 24 ) and lower cooking loss and thiobarbituric acid reacting substance values at 0 , 30 , and 60 min of forced oxidation . Rabbits in C group had higher cortisol levels , creatine kinase activities , white blood cell counts , neutrophil percentage , neutrophil : lymphocyte ratio and lower T ( 3 ) , T ( 4 ) levels , lymphocyte percentage than N and CT10 groups . Supplementation of CT seemed to have a positive effect on growth performance , welfare , and meat quality of rabbits under high ambient temperature .

chestnut tannins


A high intake of trans fatty acids has little effect on markers of inflammation and oxidative stress in humans . Consumption of industrial trans fatty acids ( iTFA ) increases LDL cholesterol , decreases HDL cholesterol , and is strongly associated with a higher risk of cardiovascular disease ( CVD ) . However , changes in circulating cholesterol can not explain the entire effect . Therefore , we studied whether iTFA and conjugated linoleic acid ( CLA ) affect markers of inflammation and oxidative stress . Sixty-one healthy adults consumed each of 3 diets for 3 wk , in random order . Diets were identical except for 7 % of energy provided by oleic acid ( control diet ) , iTFA , or CLA . At the end of the 3 wk , we measured plasma inflammatory markers IL-6 , C-reactive protein , tumor necrosis factor receptors I and II ( TNF-RI and -RII ) , monocyte chemotactic protein-1 and E-selectin , and urinary 8-iso-PGF ( 2α ) , a marker of lipid peroxidation . Consumption of iTFA caused 4 % lower TNF-RI concentrations and 6 % higher E-selectin concentrations compared with oleic acid ( control ) and had no significant effect on other inflammatory markers . CLA did not significantly affect inflammatory markers . The urine concentration of 8-iso-PGF ( 2α ) [ geometric mean ( 95 % CI ) ] was greater after the iTFA [ 0.54 ( 0.48 , 0.60 ) nmol/mmol creatinine ] and the CLA [ 1.2 ( 1.1 , 1.3 ) nmol/mmol creatinine ] diet periods than after the control period [ 0.45 ( 0.41 , 0.50 ) nmol/mmol creatinine ; P < 0.05 ] . In conclusion , high intakes of iTFA and CLA did not substantially affect plasma concentrations of inflammatory markers , but they increased the urine 8-iso-PGF ( 2α ) concentration . However , it is unlikely this plays a major role in the mechanism by which iTFA increase the risk of CVD . However , more research is needed to fully understand the implications of these findings .

trans fatty acids

industrial trans fatty acids ( iTFA )

iTFA

conjugated linoleic acid ( CLA )

diets

oleic acid ( control diet )

iTFA

CLA

Sixty-one

adults


Increased 5α-reductase type 2 expression in human breast carcinoma following aromatase inhibitor therapy : the correlation with decreased tumor cell proliferation . Tumor cell proliferation and progression of breast cancer are influenced by female sex steroids . However , not all breast cancer patients respond to aromatase inhibitors ( AI ) , and many patients become unresponsive or relapse . Recent studies demonstrate that not only estrogens but also androgens may serve as regulators of estrogen-responsive as well as estrogen-unresponsive human breast cancers . However , the mechanism underlying these androgenic actions has remained relatively unknown . Therefore , in this study , we evaluated the effects of AI upon the expression of enzymes involved in intratumoral androgen production including 17β-hydroxysteroid dehydrogenase type 5 ( 17βHSD5 ) , 5α-reductase types 1 and 2 ( 5αRed1 and 5αRed2 ) as well as androgen receptor ( AR ) levels and correlated the findings with therapeutic responses including Ki67 labeling index ( Ki67 ) . Eighty-two postmenopausal invasive ductal carcinoma patients were enrolled in CAAN study from November 2001 to April 2004 . Pre- and post-treatment specimens of 29 cases were available for this study . The status of 17βHSD5 , 5αRed1 , 5αRed2 , and Ki67 in pre- and post-treatment specimens were evaluated . The significant increments of 5αRed2 as well as AR were detected in biological response group whose Ki67 LI decreased by more than 40 % of the pre-treatment level . This is the first study demonstrating an increment of 5αRed2 and AR in the group of the patients associated with Ki67 decrement following AI treatment . These results suggest that increased 5αRed2 and AR following AI treatment may partly contribute to reduce the tumor cell proliferation through increasing intratumoral androgen concentrations and its receptor .


A feasibility study exploring the role of Chinese herbal medicine in the treatment of endometriosis . BACKGROUND Endometriosis is a common and disabling gynecologic condition affecting between 5 % and 15 % of women of childbearing age . Conventional medical intervention has unpleasant side-effects , and symptoms frequently return after treatment . Preliminary evidence suggests Chinese herbal medicine ( CHM ) may contribute to the treatment of endometriosis . OBJECTIVES The aims of this study were to test the feasibility of a novel methodology for investigating individualized decoctions of CHM rigorously and to gather preliminary data on the treatment effect of CHM for a larger definitive trial . DESIGN This was a 16-week prospective , double blinded , randomized controlled trial of 40 women with laparoscopically confirmed endometriosis . SETTINGS The trial was conducted at a private CHM clinic in Hove ( U.K. ) and at a National Health Service outpatient clinic in London ( U.K. ) . INTERVENTIONS Participants were initially randomized to either wait-list control ( WLC ) or treatment groups to receive either individualized CHM decoctions or a therapeutically inert placebo decoction . OUTCOME MEASURES Four 10-cm visual analogue scales ( VAS ) were used to measure menstrual pain , daily pain , and pain on intercourse and bowel movement ; these measurements were recorded weekly . The Endometriosis Health Profile-30 ( EHP-30 ) endometriosis-specific quality-of-life questionnaire was completed at the beginning and at the end of the trial . The Measure Yourself Medical Outcomes Profile ( MYMOP ) a patient-centered health questionnaire was completed monthly . Liver and renal function was measured at 0 , 4 , 8 , and 16 weeks . RESULTS Twenty-eight ( 28 ) women completed the trial . High dropout rates led to the suspension of the WLC . Randomization , double blinding , and allocation concealment was achieved successfully . Adjusted mean differences favored the active treatment in the EHP-30 and MYMOP scores . VAS scores favored the active treatment for relief of menstrual pain and the placebo group for reduction of daily pain . CONCLUSIONS the methodology successfully allowed individualized CHM decoctions to be tested rigorously . There are nonspecific contextual effects from CHM that require further investigation . Provisional data were generated to warrant a larger , more-definitive study .

Chinese herbal medicine

Chinese herbal medicine ( CHM )

wait-list control ( WLC )

individualized CHM decoctions

therapeutically inert placebo decoction

Liver and renal function

EHP-30 and MYMOP scores

VAS scores


Behavioral effects of Org 2766 , a synthetic analog of the adrenocorticotrophic hormone ( 4-9 ) , in 14 outpatient autistic children . Fourteen children ( 12 infantile autism full syndrome present , 2 atypical pervasive developmental disorder ) between 5 and 13 years of age participated in a double-blind placebo-controlled cross-over trial . Each child received 20 mg Org 2766 ( synthetic analog of ACTH 4-9 ) /day during 4 weeks , or placebo in a randomly assigned sequence . Drug effects were monitored by ethological playroom observation and by Aberrant Behavior Checklist ratings by parents and teachers . Data of the playroom observation pointed to an activating influence of Org 2766 , as revealed by a significant decrease of stereotypic behavior and significant increases in " change toys , " " locomote , " and " talk . " Checklist ratings did not show significant changes . The clinical implications of these findings are discussed .

Org 2766

Org 2766

synthetic analog of ACTH

placebo

Drug

Behavioral effects

ethological playroom observation

Aberrant Behavior Checklist ratings

activating influence

stereotypic behavior

outpatient autistic

Fourteen

infantile autism full syndrome

5 and 13


To share or not to share : a randomized trial of consent for data sharing in genome research . PURPOSE Despite growing concerns toward maintaining participants ' privacy , individual investigators collecting tissue and other biological specimens for genomic analysis are encouraged to obtain informed consent for broad data sharing . Our purpose was to assess the effect on research enrollment and data sharing decisions of three different consent types ( traditional , binary , or tiered ) with varying levels of control and choices regarding data sharing . METHODS A single-blinded , randomized controlled trial was conducted with 323 eligible adult participants being recruited into one of six genome studies at Baylor College of Medicine in Houston , Texas , between January 2008 and August 2009 . Participants were randomly assigned to one of three experimental consent documents ( traditional , n = 110 ; binary , n = 103 ; and tiered , n = 110 ) . Debriefing in follow-up visits provided participants a detailed review of all consent types and the chance to change data sharing choices or decline genome study participation . RESULTS Before debriefing , 83.9 % of participants chose public data release . After debriefing , 53.1 % chose public data release , 33.1 % chose restricted ( controlled access database ) release , and 13.7 % opted out of data sharing . Only one participant declined genome study participation due to data sharing concerns . CONCLUSION Our findings indicate that most participants are willing to publicly release their genomic data ; however , a significant portion prefers restricted release . These results suggest discordance between existing data sharing policies and participants ' judgments and desires .

consent for data sharing

informed consent

controlled

experimental consent documents

data sharing .

consent for data sharing

public data release

opted out of data sharing

data sharing concerns

publicly release

restricted release

genome research

adult


A web-based approach to address cardiovascular risks in managers : results of a randomized trial . OBJECTIVES To examine whether a Web-based health and leadership development program -- designed specifically for managers -- was associated with changes in self-reported and biometric indicators of cardiovascular disease within the context of a randomized control trial . METHODS A total of 145 managers from 8 organizations participated in a 6-month Internet-based program or a control condition . They completed pre- and posttest assessments that included both self-reported attitudes ( on diet , exercise , and mental health ) and biometric measures ( eg , body weight , waist circumference ) . RESULTS The intervention was associated with improvements in dietary attitudes , dietary self-efficacy , and exercise , and reductions in distress symptoms . Women in the program reduced their waist circumference significantly more than controls . CONCLUSIONS The program showed promise for reducing cardiovascular disease risk factors . Similar results across diverse organizations suggest the program may be useful across industry types .

web-based approach

6-month Internet-based program or a

control condition

intervention

cardiovascular risks

waist circumference

cardiovascular disease risk factors

cardiovascular risks


A communication-based intervention for nonverbal children with autism : what changes ? Who benefits ? OBJECTIVE This article examines the form and function of spontaneous communication and outcome predictors in nonverbal children with autism following classroom-based intervention ( Picture Exchange Communication System [ PECS ] training ) . METHOD 84 children from 15 schools participated in a randomized controlled trial ( RCT ) of PECS ( P. Howlin , R. K. Gordon , G. Pasco , A . Wade , & T. Charman , 2007 ) . They were aged 4-10 years ( 73 boys ) . Primary outcome measure was naturalistic observation of communication in the classroom . Multilevel Poisson regression was used to test for intervention effects and outcome predictors . RESULTS Spontaneous communication using picture cards , speech , or both increased significantly following training ( rate ratio [ RR ] =1.90 , 95 % CI [ 1.46 , 2.48 ] , p < .001 ; RR = 1.77 , 95 % CI [ 1.35 , 2.32 ] , p < .001 ; RR = 3.74 , 95 % CI [ 2.19 , 6.37 ] , p < .001 , respectively ) . Spontaneous communication to request objects significantly increased ( RR = 2.17 , 95 % CI [ 1.75 , 2.68 ] , p < .001 ) , but spontaneous requesting for social purposes did not ( RR = 1.34 , 95 % CI [ 0.83 , 2.18 ] , p = .237 ) . Only the effect on spontaneous speech persisted by follow-up ( 9 months later ) . Less severe baseline autism symptomatology ( lower Autism Diagnosis Observation Schedule [ ADOS ] score ; C. Lord et al. , 2000 ) was associated with greater increase in spontaneous speech ( RR = 0.90 , 95 % CI [ 0.83 , 0.98 ] , p = .011 ) and less severe baseline expressive language impairment ( lower ADOS item A1 score ) , with larger increases in spontaneous use of speech and pictures together ( RR = 0.62 , 95 % CI [ 0.44 , 0.88 ] , p = .008 ) . CONCLUSION Overall , PECS appeared to enhance children 's spontaneous communication for instrumental requesting using pictures , speech , or a combination of both . Some effects of training were moderated by baseline factors . For example , PECS appears to have increased spontaneous speech in children who could talk a little at baseline .

communication-based intervention

PECS

spontaneous speech

spontaneous speech

children

children

autism

children

4-10 years

boys


Effect of shearing on water turnover and thermobiological variables in German Blackhead mutton sheep . Current equations for estimating water requirements in sheep do not differentiate between shorn and unshorn sheep . Furthermore , the effect of shearing on thermoregulative responses in sheep has not been adequately studied under temperate environmental conditions . Therefore , the present study was conducted to investigate the effect of wool coverage on water turnover in relation to thermoregulation in sheep by using the deuterium dilution technique to predict total water intake before and after shearing . Physiological responses , such as water turnover , surface temperature , and rectal temperature , as well as drinking behavior of sheep were also evaluated . Fourteen nonlactating German Blackhead mutton ewes were randomly allocated into 2 groups : a control group ( n = 7 ) that was already shorn , and a treatment group ( n = 7 ) that was left unshorn ( wool length : 10.6 ± 1.2 cm ) . Individual feed and water intakes were recorded throughout the experiment ( d 1 to 71 ) . Two weeks after measurements commenced ( d 15 ) , treatment sheep were shorn . Water intake was estimated twice for 2 consecutive weeks by using deuterium dilution techniques ( d 1 to 15 and d 57 to 71 ) . Ambient temperature ( T ( a ) ) , relative humidity , and respiratory rate were measured daily , whereas BW , rectal and animal surface temperatures ( using infrared thermography ) , and wool length were measured weekly . In the first 2 wk , when treatment sheep were unshorn , treatment and control ewes differed ( P < 0.05 ) in DMI ( 52 ± 4 vs. 59 ± 4 g·kg ( -0.75 ) ·d ( -1 ) ) , water intake ( 165 ± 17 vs. 134 ± 18 g·kg ( -0.75 ) ·d ( -1 ) ) , respiratory rate ( 66 ± 5 vs. 31 ± 4 breath/min ) , rectal temperature ( 39.3 ± 0.2 vs. 38.8 ± 0.1°C ) , and surface temperatures ( body side : 19.3 ± 0.3 vs. 24.5 ± 0.6°C ; leg : 25.8 ± 2.4 vs. 27.4 ± 1.6°C ) . However , after shearing , these differences partly disappeared . The same trend in water intake between groups was confirmed using the isotope dilution technique . We found a significant relationship between T ( a ) and water intake , respiratory rate , and body surface temperatures . Even under temperate conditions ( T ( a ) < 28°C ) , shearing significantly reduced core body temperature , water intake , and respiratory rate in German Blackhead mutton sheep , thus indicating heat stress in fleeced animals , which should be considered when determining the optimal shearing time in sheep as well as when estimating water requirements .

shearing

shearing

a control group

already shorn

left unshorn

thermoregulative responses

water turnover

drinking behavior

Fourteen

nonlactating


Effect of ginseng extract supplementation on testicular functions in diabetic rats . OBJECTIVE It was aimed to investigate the effect of standardized ginseng extract on fertility parameters in diabetic rats . METHODS Thirty male rats were randomly allocated into three groups of 10 rats each : 1. controls , 2. diabetes ( D ) and 3. diabetes + ginseng ( DG ) . The latter two groups were rendered diabetic by i.p . injection of streptozotocin ( STZ ; 50 mg/kg ) . Standardized ginseng extract ( Dansk Droge A/S , Copenhagen , Denmark ) was administered per os ( 100 mg/kg BW ) by stomach tube daily for 90 days starting one week after STZ . Ninety days post STZ the rats were sacrificed , and testis , epididymis , prostate , and seminal vesicles were weighed and subjected to histological examination . In addition , spermiogram , testicular enzyme markers , intratesticular steroid hormonal profile and testicular antioxidant status were estimated . RESULTS The administration of ginseng extract resulted in a significant improvement of fertility parameters and testicular antioxidants together with a decrease in malondialdehyde and testicular pathological signs including degenerative changes of the seminiferous tubules . CONCLUSION Ginseng extract may be a beneficial adjuvant therapy for diabetics suffering from infertility as a complication .

ginseng extract supplementation

ginseng extract

streptozotocin

Standardized ginseng extract

ginseng extract

Ginseng extract

testicular functions

fertility parameters

infertility

diabetic

diabetic rats

Thirty

male


Low-dose magnesium sulfate versus Pritchard regimen for the treatment of eclampsia imminent eclampsia .

Low-dose magnesium sulfate

Pritchard regimen

eclampsia imminent eclampsia .


Nasal versus oronasal continuous positive airway pressure masks for obstructive sleep apnea : a pilot investigation of pressure requirement , residual disease , and leak . PURPOSE This single-blinded , randomized , controlled pilot study aimed to investigate whether there is a difference between nasal and oronasal masks in therapeutic continuous positive airway pressure ( CPAP ) requirement , residual disease , or leak when treating obstructive sleep apnea ( OSA ) and if differences were related to measures of upper airway size . METHODS Patients with severe OSA currently using CPAP at ≥4 h/night with a nasal mask were examined ( including Mallampati scale , incisal relationship , and mandibular protrusion ) and then randomized to receive auto-positive airway pressure ( PAP ) or fixed CPAP at a manually titrated pressure for 1 week each at home , with immediate crossover . Within each week , a nasal mask and two oronasal masks were to be used for two or three nights each in random order . Data were downloaded from the device . RESULTS Twelve patients completed the trial ( mean ± SD AHI 59.8 ± 28.6 events/h ; CPAP 11.1 ± 3.2 cmH ( 2 ) O ; BMI 37.7 ± 5.0 kg/m ( 2 ) ) . During auto-PAP , the median 95th percentile pressure delivered with all masks was within 0.5 cmH ( 2 ) O ( p > 0.05 ) . During CPAP , median residual AHI was 0.61 ( IQR = 1.18 ) for the nasal mask , 1.70 ( IQR = 4.04 ) for oronasal mask 1 , and 2.48 ( IQR = 3.74 ) for oronasal mask 2 ( p = 0.03 ) . The 95th percentile leak was lowest with the nasal mask during both CPAP and auto-PAP ( both p < 0.01 ) . Differences in pressure or residual disease were not related to measures of upper airway shape or body habitus . CONCLUSIONS In obese OSA patients changing from a nasal to oronasal mask increased leak and residual AHI but did not affect the therapeutic pressure requirement . The findings of the current study highlight mask leak as the major difficulty in the use of oronasal masks .

nasal and oronasal masks

obstructive sleep apnea :

obstructive sleep apnea ( OSA )

Twelve


Preliminary examination of a cartoon-based hostile attributional bias measure for urban African American boys . The current study illustrates how researchers developed and validated a cartoon-based adaptation of a written hostile attributional bias measure for a sample of urban , low-income , African American boys . A series of studies were conducted to develop cartoon illustrations to accompany a standard written hostile attributional bias vignette measure ( Study 1 ) , to determine initial psychometric properties ( Study 2 ) and acceptability ( Study 3 ) , and to conduct a test-retest reliability trial of the adapted measure in a separate sample ( Study 4 ) . These studies utilize a participatory action research approach to measurement design and adaptation , and suggest that collaborations between researchers and key school stakeholders can lead to measures that are psychometrically strong , developmentally appropriate , and culturally sensitive . In addition , the cartoon-based hostile attributional bias measure appears to have promise as an assessment and/or outcome measure for aggression and bullying prevention programs conducted with urban African American boys .

cartoon-based adaptation

hostile attributional bias measure

hostile attributional bias measure

psychometric properties

acceptability

test-retest reliability

hostile attributional bias measure

urban African American boys


Falls and mobility in Parkinson 's disease : protocol for a randomised controlled clinical trial . BACKGROUND Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson 's disease , this has not yet been confirmed with a large scale randomised controlled clinical trial . The study will investigate the effects on falls , mobility and quality of life of ( i ) movement strategy training combined with falls prevention education , ( ii ) progressive resistance strength training combined with falls prevention education , ( iii ) a generic life-skills social program ( control group ) . METHODS/DESIGN People with idiopathic Parkinson 's disease who live at home will be recruited and randomly allocated to one of three groups . Each person shall receive therapy in an out-patient setting in groups of 3-4 . Each group shall be scheduled to meet once per week for 2 hours for 8 consecutive weeks . All participants will also have a structured 2 hour home practice program for each week during the 8 week intervention phase . Assessments will occur before therapy , after the 8 week therapy program , and at 3 and 12 months after the intervention . A falls calendar will be kept by each participant for 12 months after outpatient therapy.Consistent with the recommendations of the Prevention of Falls Network Europe group , three falls variables will be used as the primary outcome measures : the number of fallers , the number of multiple fallers and the falls rate . In addition to quantifying falls , we shall measure mobility , activity limitations and quality of life as secondary outcomes . DISCUSSION This study has the potential to determine whether outpatient movement strategy training combined with falls prevention education or progressive resistance strength training combined with falls prevention education are effective for reducing falls and improving mobility and life quality in people with Parkinson 's disease who live at home . TRIAL REGISTRATION Australia and New Zealand Clinical Trials Register ( ANZCTR ) : ACTRN12606000344594 .

physical therapy

falls prevention education

movement strategy training

falls prevention education

strength training

falls prevention education

generic life-skills social program

therapy

home practice program

Falls and mobility

falls

disability

falls

mobility

quality of life

falls

the number of fallers

the number of multiple fallers

falls rate

falls

mobility

activity limitations

quality of life

reducing falls

improving mobility

life quality

Parkinson 's disease

Parkinson 's disease

idiopathic Parkinson 's disease

Parkinson 's disease


MRI signal hyperintensities and failure to remit following antidepressant treatment . BACKGROUND MRI signal hyperintensities predict poor remission to antidepressant treatment . Previous studies using volumetrics in outpatient samples have relied on total lesion volume . The purpose of this study was to test whether remission from geriatric depression depends on lesion volume by region of interest ( ROI ) . METHOD Thirty-eight patients received baseline MRIs as part of a larger 12-week , randomized clinical trial comparing sertraline and nortriptyline in the treatment of late-life depression . MRIcro was used to quantify MRI-hyperintensity volume into total hyperintensity , deep white matter hyperintensity ( DWMH ) , and periventricular hyperintensity ( PVH ) volumes . High versus low total , DWMH , and PVH volumes were defined based on the highest quartile of their respective distributions . Remission from depression was defined as a 24-item Hamilton Rating Scale for Depression score ≤ 7 for two consecutive weeks . RESULTS Patients classified as having high DWMH were 7.14 times more likely not to remit following antidepressant treatment compared to patients classified as having low DWMH ( p=0.02 ) . Similar odds ratios were obtained for PVH ( OR=4.17 , p=0.16 ) and total volumes ( OR=5.00 , p=0.05 ) . Importantly , adjusting for age did not change the magnitude of these effects . LIMITATIONS A small and predominantly White sample . CONCLUSIONS This is the first study to test whether remission from geriatric depression depends on lesion volume by ROI in an outpatient sample . The pattern of remission rates and odds ratios was similar when patients were classified as having high DWMH , PVH or total volume suggesting that lesion location may not be critical .

antidepressant treatment

antidepressant treatment

baseline MRIs

sertraline

nortriptyline

MRI signal hyperintensities

and

failure to remit

remission

total lesion volume

DWMH

, and

PVH volumes

Remission from depression

geriatric depression

Thirty-eight

late-life depression


Comparative evaluation of cefotaxime and cephamandole in the prevention of post-operative infective complications following emergency abdominal surgery . In previous published work we described 57 patients undergoing emergency abdominal surgery , prospectively randomised to receive either cefotaxime or cephamandole as a single-antibiotic , three-dose , peri-operative prophylaxis against post-operative infective complications . This earlier work suggested that cefotaxime might be more effective than cephamandole in preventing wound sepsis in emergency abdominal surgery . We describe here our findings in a further 63 patients undergoing emergency abdominal surgery who were similarly allocated into either a cefotaxime or cephamandole antibiotic group . Infective complications occurred in 12/32 ( 37 per cent ) of the cefotaxime group and 15/31 ( 48 per cent ) of the cephamandole group . Wound infections occurred in 5/32 ( 16 per cent ) of the cefotaxime group and 9/31 ( 29 per cent ) of the cephamandole group . The organisms cultured and their sensitivities are discussed in detail . The total of 120 patients studied in the two series showed wound infection to occur in 13 per cent of the 62 patients receiving cefotaxime and 30 per cent of the 58 patients receiving cephamandole . This difference reaches statistical significance ( p less than 0.05 ) . Possible mechanisms to explain this finding are discussed . Again we found the regime of 4 g of cefotaxime given peri-operatively to be a simple , safe and effective single agent as prophylaxis for emergency abdominal surgery .

cefotaxime

cephamandole

abdominal surgery

emergency abdominal surgery

cefotaxime

cephamandole

cefotaxime

cephamandole

emergency abdominal surgery

cefotaxime

cephamandole

cefotaxime

cephamandole

cefotaxime

cephamandole

cefotaxime

cephamandole

cefotaxime

emergency abdominal surgery

post-operative infective complications

Infective complications

Wound infections

wound infection


[ Use of Tachocomb for prevention of postoperative lymphatic leaks in the abdomen ] .

Tachocomb

lymphatic leaks


The effect of knee position on blood loss and range of motion following total knee arthroplasty . PURPOSE This study prospectively assessed the effects of knee position on blood loss and range of motion after primary total knee arthroplasty ( TKA ) . METHODS One hundred and ten consecutive TKA patients were randomized into flexion group and extension group . Both groups had the leg elevated 30° at the hip over an inactive CPM for 72 h postoperatively . The flexion group had the knee flexed to 30° during this period . The extension group had the knee extended fully . Perioperative blood loss , hidden blood loss , knee swelling , ecchymosis , analgesia requirements , range of motion ( ROM ) , fixed flexion deformity ( FFD ) , straight-leg raising action , and postoperative complications within 6 weeks of surgery were measured for evaluation and comparison . RESULTS The postoperative hidden blood loss , knee swelling , and scope of ecchymosis were significantly lower in the flexion group than in the extension group , and ROM and straight-leg raising action were significantly higher during the early period after operation . No significant difference was observed in perioperative blood loss , the amount of morphine used , or FFD in the early postoperative period or in ROM and FFD at 6 weeks postoperatively . CONCLUSIONS The findings of this study indicate that flexion of the knee to 30° with the leg elevated 30° at the hip after total knee arthroplasty may mitigate knee swelling and provide other beneficial results during the early rehabilitation following TKA . LEVEL OF EVIDENCE Prospective comparative study , Level I .

knee position

knee position

blood loss

range of motion

blood loss

range of motion


Using a population-based cancer registry for recruitment in a pilot cancer control study . Cancer control investigations in the United States rarely use population-based registries as a resource for recruitment . A placebo-controlled , double-blind , randomized toxicity trial of tamoxifen was conducted among postmenopausal women with node negative breast cancer . To achieve the accrual goal of 140 subjects in this single institution study , the Wisconsin Cancer Reporting System ( WCRS ) , a population-based cancer registry , was used . Registry information from the last 9 years was used to identify 3,585 women who met the study criteria with respect to age , stage , and previous therapy . The vital status of identified women was confirmed using Wisconsin state death records . For identified cases , rosters were prepared and sent to the physician with a cover letter and study description . The physicians were asked to update the list and , if appropriate , to sign letters to potentially eligible and interested women . Thirty-eight percent of women receiving a letter and study information from their physicians contacted the study office about participation . Eighteen months from its initiation , 140 women were entered on study . This successful use of a population-based cancer registry illustrates an efficient recruitment method which could be modified for other cancer control/chemoprevention trials .

placebo-controlled

tamoxifen

population-based cancer registry

efficient recruitment method

cancer

postmenopausal

node negative breast cancer .

Cancer

cancer

women

cancer


Variability of thrombolytic coronary reperfusion : an angiographic study of streptokinase and anistreplase . A total of 1,615 angiographic readings in 240 patients with acute myocardial infarction were analyzed from a randomized trial of intravenous anistreplase ( Eminase ) , also known as anisoylated plasminogen streptokinase activator complex ( APSAC ) , versus intracoronary streptokinase . Coronary arteriography was performed at baseline and at 15 , 30 , 45 , 60 , 75 , and 90 minutes after drug infusion . Coronary flow in the infarct-related artery was defined using the TIMI criteria . Some serial change in perfusion was noted in 25 % of the total patient population and in 49 % of all reperfusion patients . Complete loss of perfusion ( grade 2 or 3 to grade 0 or 1 ) occurred in 35 % of all reperfused patients . Half of these patients ultimately developed complete loss of perfusion at the study endpoint . All of these changes in flow were statistically more common for the circumflex coronary artery and early treatment ( less than 4 h ) , but did not differ for anistreplase or streptokinase . We conclude that frequent alterations in coronary blood flow occur early during reperfusion therapy and that these findings may explain reports with varying results of thrombolytic therapy . Any angiographic assessment of thrombolytic drug efficacy should take these variations as well as interobserver variability into account .

thrombolytic coronary reperfusion

streptokinase

anistreplase

streptokinase

anistreplase

streptokinase

reperfusion therapy

thrombolytic therapy

thrombolytic drug

serial change in perfusion

Complete loss of perfusion

loss of perfusion

alterations in coronary blood flow

acute myocardial infarction


Predictors and moderators of parent training efficacy in a sample of children with autism spectrum disorders and serious behavioral problems . The Research Units on Pediatric Psychopharmacology -- Autism Network reported additional benefit when adding parent training ( PT ) to antipsychotic medication in children with autism spectrum disorders and serious behavior problems . The intent-to-treat analyses were rerun with putative predictors and moderators . The Home Situations Questionnaire ( HSQ ) and the Hyperactivity/Noncompliance subscale of the Aberrant Behavior Checklist were used as outcome measures . Candidate predictors and moderators included 21 demographics and baseline measures of behavior . Higher baseline HSQ scores predicted greater improvement on the HSQ regardless of treatment assignment , but no other predictors of outcome were observed . None of the variables measured in this study moderated response to PT . Antipsychotic medication plus PT appears to be equally effective for children with a wide range of demographic and behavioral characteristics .

adding parent training ( PT ) to

plus PT

HSQ scores

children

autism spectrum disorders

serious behavioral problems

children

autism spectrum disorders

children


Using the transporters DVD as a learning tool for children with Autism Spectrum Disorders ( ASD ) . Data from two groups of children who were randomly allocated to those groups showed that the ability of children with ASD to identify and label basic and complex facial expressions following a 3-week home based DVD intervention significantly improved when viewing The Transporters DVD . Improvements in emotion recognition appear related to the content of the DVD as participants in a control group who observed an alternate DVD showed no such improvement . Although social behaviour improved significantly as a result of watching The Transporters , a significant improvement in social behaviour was however , also observed in the Thomas the Tank Engine condition suggesting the unique content of The Transporters DVD was not pivotal to the improvement of social behaviour in general .

transporters DVD

learning tool

home based DVD intervention

The Transporters DVD

DVD

alternate DVD

Transporters DVD

emotion recognition

social behaviour

social behaviour

social behaviour

children

Autism Spectrum Disorders ( ASD

two groups

children

children


The clinician 's decision of whether CHOP chemotherapy should be standard therapy for treatment of patients with diffuse histiocytic lymphoma .

CHOP chemotherapy

diffuse histiocytic lymphoma


Rivaroxaban versus warfarin in nonvalvular atrial fibrillation . BACKGROUND The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment . Rivaroxaban , an oral factor Xa inhibitor , may provide more consistent and predictable anticoagulation than warfarin . METHODS In a double-blind trial , we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban ( at a daily dose of 20 mg ) or dose-adjusted warfarin . The per-protocol , as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism . RESULTS In the primary analysis , the primary end point occurred in 188 patients in the rivaroxaban group ( 1.7 % per year ) and in 241 in the warfarin group ( 2.2 % per year ) ( hazard ratio in the rivaroxaban group , 0.79 ; 95 % confidence interval [ CI ] , 0.66 to 0.96 ; P < 0.001 for noninferiority ) . In the intention-to-treat analysis , the primary end point occurred in 269 patients in the rivaroxaban group ( 2.1 % per year ) and in 306 patients in the warfarin group ( 2.4 % per year ) ( hazard ratio , 0.88 ; 95 % CI , 0.74 to 1.03 ; P < 0.001 for noninferiority ; P=0.12 for superiority ) . Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group ( 14.9 % per year ) and in 1449 in the warfarin group ( 14.5 % per year ) ( hazard ratio , 1.03 ; 95 % CI , 0.96 to 1.11 ; P=0.44 ) , with significant reductions in intracranial hemorrhage ( 0.5 % vs. 0.7 % , P=0.02 ) and fatal bleeding ( 0.2 % vs. 0.5 % , P=0.003 ) in the rivaroxaban group . CONCLUSIONS In patients with atrial fibrillation , rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism . There was no significant between-group difference in the risk of major bleeding , although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group . ( Funded by Johnson & Johnson and Bayer ; ROCKET AF ClinicalTrials.gov number , NCT00403767 . ) .

Rivaroxaban

warfarin

warfarin

Rivaroxaban

warfarin

rivaroxaban

warfarin

rivaroxaban

warfarin

rivaroxaban

warfarin

rivaroxaban

rivaroxaban

warfarin

rivaroxaban

warfarin

rivaroxaban

rivaroxaban

rivaroxaban

rate of ischemic stroke

stroke or systemic embolism

intracranial hemorrhage

fatal bleeding

major bleeding

intracranial and fatal bleeding

nonvalvular atrial fibrillation .

14,264 patients


Atypical social modulation of imitation in autism spectrum conditions . Appropriate modulation of imitation according to social context is important for successful social interaction . In the present study we subliminally primed high-functioning adults with ASC and age- and IQ-matched controls with either a pro- or non- social attitude . Following priming , an automatic imitation paradigm was used to acquire an index of imitation . Whereas imitation levels were higher for pro-socially primed relative to non-socially primed control participants , there was no difference between pro- and non- socially primed individuals with ASC . We conclude that high-functioning adults with ASC demonstrate atypical social modulation of imitation . Given the importance of imitation in social interaction we speculate that difficulties with the modulation of imitation may contribute to the social problems characteristic of ASC .

Atypical social modulation

modulation of imitation

atypical social modulation of imitation

imitation in social interaction

index of imitation

imitation levels

atypical social modulation of imitation

autism spectrum conditions

high-functioning adults

control participants

individuals with ASC

adults

ASC .


Treatment of renal failure associated with multiple myeloma . Plasmapheresis , hemodialysis , and chemotherapy . The aims of this study were to examine in a prospective , randomized trial the efficacy of plasmapheresis in preventing irreversible renal failure in patients with multiple myeloma and to study the renal biopsy tissues from such patients . Twenty-one patients with active myeloma and progressive renal failure were randomized to one of two groups : group 1 , forced diuresis and chemotherapy ( 10 patients ) , and group 2 , forced diuresis , chemotherapy , and plasmapheresis ( 11 patients ) . Plasmapheresis and chemotherapy lowered the serum myeloma protein value much more rapidly than chemotherapy alone . Of 5 patients who were oliguric and undergoing dialysis at presentation , only 3 who were treated by plasmapheresis recovered . Of 16 polyuric patients , 5 in group 1 and 7 in group 2 showed improvement in renal function . The main factor that determined irreversibility of renal failure was the severity of myeloma cast formation .

forced

diuresis

chemotherapy

forced diuresis

chemotherapy

plasmapheresis

renal failure

irreversible renal failure

serum myeloma protein value

renal function

renal failure

multiple myeloma

Twenty-one

myeloma


Topical PUVA , etretinate , and combined PUVA and etretinate for palmoplantar pustulosis : comparison of therapeutic efficacy and the influences of tonsillar and dental focal infections . Twenty patients with palmoplantar pustulosis ( PPP ) were treated with topical PUVA , oral etretinate ( Re ) , or combined PUVA and etretinate ( Re-PUVA ) . Re and Re-PUVA treated sites improved and/or cleared more rapidly than PUVA treated sites . Complete clearance was observed in six of ten sites treated with Re-PUVA , two of ten with Re , and one of ten sites with PUVA within 12 weeks . UVA-control sites failed to be cleared within 12 weeks . Remission periods after stopping the treatment were 1.5 +/- 0.5 weeks ( n = 2 ) with Re , 10.5 +/- 11.4 weeks ( n = 6 ) with Re-PUVA , and one year ( n = 1 ) with PUVA . These results overall suggested that Re-PUVA is the most effective treatment for PPP . Tonsillar focal infection ( TFI ) and dental focal infection ( DFI ) were found in 6/20 and 17/20 patients , respectively . However , the presence of focal infection ( FI ) , TFI and/or DFI , did not appear to interfere with the therapeutic activities of Re and/or PUVA , because the complete clearance rates and remission periods in FI ( + ) patients were comparable with those in FI ( - ) patients .

Topical PUVA

etretinate

combined PUVA and etretinate

topical PUVA

oral etretinate ( Re )

therapeutic efficacy

tonsillar

sites improved and/or cleared

Complete clearance

cleared

Remission periods

Tonsillar focal infection ( TFI )

dental focal infection ( DFI )

focal infection ( FI )

TFI

DFI

complete clearance rates

remission periods

Twenty

palmoplantar pustulosis ( PPP )


Comparative effectiveness of exercise electrocardiography with or without myocardial perfusion single photon emission computed tomography in women with suspected coronary artery disease : results from the What Is the Optimal Method for Ischemia Evaluation in Women ( WOMEN ) trial . BACKGROUND There is a paucity of randomized trials regarding diagnostic testing in women with suspected coronary artery disease ( CAD ) . It remains unclear whether the addition of myocardial perfusion imaging ( MPI ) to the standard ECG exercise treadmill test ( ETT ) provides incremental information to improve clinical decision making in women with suspected CAD . METHODS AND RESULTS We randomized symptomatic women with suspected CAD , an interpretable ECG , and ≥5 metabolic equivalents on the Duke Activity Status Index to 1 of 2 diagnostic strategies : ETT or exercise MPI . The primary end point was 2-year incidence of major adverse cardiac events , defined as CAD death or hospitalization for an acute coronary syndrome or heart failure . A total of 824 women were randomized to ETT or exercise MPI . For women randomized to ETT , ECG results were normal in 64 % , indeterminate in 16 % , and abnormal in 20 % . By comparison , the exercise MPI results were normal in 91 % , mildly abnormal in 3 % , and moderate to severely abnormal in 6 % . At 2 years , there was no difference in major adverse cardiac events ( 98.0 % for ETT and 97.7 % for MPI ; P=0.59 ) . Compared with ETT , index testing costs were higher for exercise MPI ( P < 0.001 ) , whereas downstream procedural costs were slightly lower ( P=0.0008 ) . Overall , the cumulative diagnostic cost savings was 48 % for ETT compared with exercise MPI ( P < 0.001 ) . CONCLUSIONS In low-risk , exercising women , a diagnostic strategy that uses ETT versus exercise MPI yields similar 2-year posttest outcomes while providing significant diagnostic cost savings . The ETT with selective follow-up testing should be considered as the initial diagnostic strategy in symptomatic women with suspected CAD . CLINICAL TRIAL REGISTRATION http : //www.clinicaltrials.gov . Unique identifier : NCT00282711 .

ECG

ETT

Comparative effectiveness


Increasing verbal responsiveness in parents of children with autism : a pilot study . Correlational studies have revealed a positive relationship between parent verbal responsiveness and language outcomes in children with autism . We investigated whether parents of young children on the autism spectrum could learn and implement the specific categories of verbal responsiveness that have been suggested to facilitate language development . Parents were taught to increase their verbal responsiveness in the context of a short-term language intervention that included group parent education sessions , as well as individual and small-group coaching sessions of parent-child play interactions . Parents in the treatment group increased their use of comments that : described their child 's focus of attention ; interpreted or expanded child communication acts ; and prompted child communication . Preliminary treatment effects were also noted in children 's prompted and spontaneous communication . These results support the use of parent-mediated interventions targeting verbal responsiveness to facilitate language development and communication in young children with autism .

increase their verbal responsiveness

short-term language intervention

group parent education sessions

parent-mediated interventions

child 's focus of attention

child communication acts

child communication

verbal responsiveness

language development and communication

parent

children with autism .

Parents

Parents

young children with autism .


Effect of gravity on robot-assisted motor training after chronic stroke : a randomized trial . OBJECTIVES To determine the efficacy of 2 distinct 6-week robot-assisted reaching programs compared with an intensive conventional arm exercise program ( ICAE ) for chronic , stroke-related upper-extremity ( UE ) impairment . To examine whether the addition of robot-assisted training out of the horizontal plane leads to improved outcomes . DESIGN Randomized controlled trial , single-blinded , with 12-week follow-up . SETTING Research setting in a large medical center . PARTICIPANTS Adults ( N=62 ) with chronic , stroke-related arm weakness stratified by impairment severity using baseline UE motor assessments . INTERVENTIONS Sixty minutes , 3 times a week for 6 weeks of robot-assisted planar reaching ( gravity compensated ) , combined planar with vertical robot-assisted reaching , or intensive conventional arm exercise program . MAIN OUTCOME MEASURE UE Fugl-Meyer Assessment ( FMA ) mean change from baseline to final training . RESULTS All groups showed modest gains in the FMA from baseline to final with no significant between group differences . Most change occurred in the planar robot group ( mean change ± SD , 2.94 ± 0.77 ; 95 % confidence interval [ CI ] , 1.40-4.47 ) . Participants with greater motor impairment ( n=41 ) demonstrated a larger difference in response ( mean change ± SD , 2.29 ± 0.72 ; 95 % CI , 0.85-3.72 ) for planar robot-assisted exercise compared with the intensive conventional arm exercise program ( mean change ± SD , 0.43 ± 0.72 ; 95 % CI , -1.00 to 1.86 ) . CONCLUSIONS Chronic UE deficits because of stroke are responsive to intensive motor task training . However , training outside the horizontal plane in a gravity present environment using a combination of vertical with planar robots was not superior to training with the planar robot alone .

robot-assisted motor training

robot-assisted reaching programs

conventional arm exercise program

robot-assisted training

chronic stroke

modest gains in the

FMA

chronic stroke

Adults

chronic , stroke-related arm weakness

impairment


Impact of pentoxifylline on platelet function profiles in patients with type 2 diabetes mellitus and coronary artery disease on dual antiplatelet therapy with aspirin and clopidogrel . OBJECTIVES The aim of this study was to evaluate the impact of the phosphodiesterase ( PDE ) inhibitor pentoxifylline on platelet function profiles in patients receiving dual antiplatelet therapy ( DAPT ) . BACKGROUND Previous studies have shown that , in patients receiving DAPT , the adjunctive use of a PDE inhibitor enhances platelet inhibition , particularly in those presenting with diabetes mellitus ( DM ) . However , the pharmacodynamic ( PD ) effects of the PDE inhibitor pentoxifylline on platelet function profiles in DM patients receiving DAPT are unknown . METHODS This was a prospective , randomized , double-blind , parallel design study conducted in DM patients with stable coronary artery disease receiving DAPT . Patients were randomly assigned to either pentoxifylline 400 mg or placebo 3 times daily for 14 days . The PD effects were assessed by vasodilator-stimulated phosphoprotein phosphorylation assay , light transmittance aggregometry , VerifyNow P2Y12 assay ( Accumetric , Inc. , San Diego , California ) , and multiple electrode aggregometry at baseline and 14 days . The PD effects were also assessed according the presence or absence of high on-treatment platelet reactivity status . RESULTS A total of 40 patients were available for analysis . At 14 days , there were no differences in the P2Y ( 12 ) reactivity index as assessed by vasodilator-stimulated phosphoprotein phosphorylation between treatment groups ( primary endpoint ; p = 0.93 ) . Intra-group comparisons also failed to show any differences between baseline and 14-day P2Y ( 12 ) reactivity index assessment in the placebo and pentoxifylline arms ( p = 0.61 ) . There were no significant inter- and intra-group differences in all other PD measures . The PD effects did not vary according the presence or absence of high on-treatment platelet reactivity . CONCLUSIONS Adjunctive treatment with pentoxifylline is not associated with increased platelet inhibitory effects in DM patients with coronary artery disease receiving DAPT .

pentoxifylline

PDE inhibitor

PDE inhibitor pentoxifylline

pentoxifylline 400 mg

placebo

placebo

pentoxifylline

pentoxifylline

platelet function profiles

platelet function profiles

platelet inhibition

platelet function profiles

light transmittance aggregometry

VerifyNow P2Y12 assay

San Diego , California )

multiple electrode aggregometry

P2Y ( 12 ) reactivity index

PD measures

platelet inhibitory effects

40 patients


The placebo effect . Drug trial considerations .

placebo

effect .


[ The Antonio Raichs memorial lecture . Future trends in marrow transplantation ] .

Antonio Raichs memorial lecture

marrow transplantation

marrow transplantation ]


Ameliorating intrusive memories of distressing experiences using computerized reappraisal training . The types of appraisals that follow traumatic experiences have been linked to the emergence of posttraumatic stress disorder ( PTSD ) . Could changing reappraisals following a stressful event reduce the emergence of PTSD symptoms ? The present proof-of-principle study examined whether a nonexplicit , systematic computerized training in reappraisal style following a stressful event ( a highly distressing film ) could reduce intrusive memories of the film , and symptoms associated with posttraumatic distress over the subsequent week . Participants were trained to adopt a generally positive or negative poststressor appraisal style using a series of scripted vignettes after having been exposed to highly distressing film clips . The training targeted self-efficacy beliefs and reappraisals of secondary emotions ( emotions in response to the emotional reactions elicited by the film ) . Successful appraisal induction was verified using novel vignettes and via change scores on the post traumatic cognitions inventory . Compared with those trained negatively , those trained positively reported in a diary fewer intrusive memories of the film during the subsequent week , and lower scores on the Impact of Event Scale ( a widely used measure of posttraumatic stress symptoms ) . Results support the use of computerized , nonexplicit , reappraisal training after a stressful event has occurred and provide a platform for future translational studies with clinical populations that have experienced significant real-world stress or trauma .

computerized reappraisal training .

intrusive memories

Impact of Event Scale


Effect of ozone application on the resin-dentin microtensile bond strength . When ozone is used during caries treatment , bond strength can be compromised by the release of oxygen . The use of antioxidant agents neutralizes the free oxygen . The aim of this study was to evaluate the effects of ozone and sodium ascorbate on resin-dentin microtensile bond strength ( μTBS ) . Forty human third molars were divided into four groups : Group 1 , not treated with ozone ; Group 2 , ozone application followed by acid etching ; Group 3 , acid etching followed by ozone application ; and Group 4 , ozone and application of sodium ascorbate . Bonded beams ( 1.0 mm ( 2 ) ) were tested under tension ( 0.5 mm min ( -1 ) ) . The μTBS values were analyzed using one-way analysis of variance ( ANOVA ) and the Tukey test ( p=0.05 ) . All beams that fractured were analyzed under stereomicroscopy ( 40× ) . Group 1 had significantly higher μTBS values than Group 2 or 3 . The μTBS values of Groups 1 and 4 were similar and higher than those of Group 2 . The use of ozone in Group 2 resulted in lower values of μTBS in all conditions evaluated . The predominant failure mode was adhesive . The application of ozone decreased the μTBS of the dentin-composite resin interface . These values were reversed when compared with Groups 1 and 2 when sodium ascorbate was used .

ozone application

ozone

sodium ascorbate

resin-dentin microtensile bond strength

μTBS

μTBS values

μTBS values

Forty


Effect of prophylactic amiodarone in patients with rheumatic valve disease undergoing valve replacement surgery . The study was carried out to evaluate the effect of prophylactic single-dose intravenous amiodarone in patients undergoing valve replacement surgery . Maintenance of sinus rhythm is better than maintenance of fixed ventricular rate in atrial fibrillation ( AF ) especially in the presence of irritable left or right atrium because of enlargement . Fifty-six patients with valvular heart disease with or without AF were randomly divided into two groups . Group I or the amiodarone group ( n=28 ) received amiodarone ( 3 mg/kg in 100 ml normal saline ) and group II or the control group received same volume of normal saline . The standardized protocol for cardiopulmonary bypass was maintained for all the patients . AF occurred in 7.14 % patients in group I , and in group II , 28.57 % ( P=0.035 ) ; ventricular tachycardia/fibrillation was observed in 21.43 % patients in group I and 46.43 % patients in group II ( P=0.089 ) after release of aortic clamp . Most of the patients in group I ( 92.86 % ) maintained sinus rhythm without cardioversion or defibrillation after release of aortic cross clamp ( P=0.002 ) . Defibrillation or cardio version was needed in 7.14 % patients in group I and 28.57 % patients in group II ( P=0.078 ) . A single prophylactic intraoperative dose of intravenous amiodarone decreased post bypass arrhythmia in this study in comparison to the control group . Single dose of intraoperative amiodarone may be used to decrease postoperative arrhythmia in open heart surgery .

prophylactic amiodarone

amiodarone

amiodarone group

amiodarone

normal saline

amiodarone

amiodarone

ventricular tachycardia/fibrillation

Defibrillation or cardio version

post bypass arrhythmia


Effects of a Chinese medical herbs complex on cellular immunity and toxicity-related conditions of breast cancer patients . Rose geranium ( Pelargonium graveolens , Geraniaceae ) has anti-cancer and anti-inflammatory properties , and promotes wound healing . Similarly , Ganoderma tsugae ( Ganodermataceae ) , Codonopsis pilosula ( Campanulaceae ) and Angelica sinensis ( Apiaceae ) are traditional Chinese herbs associated with immunomodulatory functions . In the present study , a randomised , double-blind , placebo-controlled study was conducted to examine whether the Chinese medicinal herb complex , RG-CMH , which represents a mixture of rose geranium and extracts of G. tsugae , C. pilosula and A. sinensis , can improve the immune cell count of cancer patients receiving chemotherapy and/or radiotherapy to prevent leucopenia and immune impairment that usually occurs during cancer therapy . A total of fifty-eight breast cancer patients who received chemotherapy or radiotherapy were enrolled . Immune cell levels in patient serum were determined before , and following , 6 weeks of cancer treatment for patients receiving either an RG-CMH or a placebo . Administration of RG-CMH was associated with a significant reduction in levels of leucocytes from 31·5 % for the placebo group to 13·4 % for the RG-CMH group . Similarly , levels of neutrophils significantly decreased from 35·6 % for the placebo group to 11·0 % for the RG-CMH group . RG-CMH intervention was also associated with a decrease in levels of T cells , helper T cells , cytotoxic T cells and natural killer cells compared with the placebo group . However , these differences between the two groups were not statistically significant . In conclusion , administration of RG-CMH to patients receiving chemotherapy/radiotherapy may have the capacity to delay , or ease , the reduction in levels of leucocytes and neutrophils that are experienced by patients during cancer treatment .

Rose geranium

Ganoderma tsugae

Codonopsis pilosula

Angelica sinensis

Chinese medicinal herb complex , RG-CMH

chemotherapy

radiotherapy

RG-CMH

placebo

placebo

Immune cell levels in patient serum

levels of leucocytes

breast cancer patients .


Symptomatic and functional improvement in employed depressed patients : a double-blind clinical trial of desvenlafaxine versus placebo . OBJECTIVE This is the first study to assess the efficacy of desvenlafaxine ( administered as desvenlafaxine succinate ) for improving depressive symptoms and functioning exclusively in employed patients with major depressive disorder ( MDD ) . METHODS Gainfully employed ( ≥20 h/wk ) male and female outpatients with MDD were randomly assigned ( 2:1 ratio ) to 12 weeks of double-blind treatment with desvenlafaxine 50 mg/d or placebo . Analysis of covariance was used to compare differences in week 12 adjusted mean changes from baseline on the 17-item Hamilton Depression Rating Scale ( HAM-D₁₇ ) ( primary outcome ) and Sheehan Disability Scale ( SDS ) ( key secondary outcome ) in the intent-to-treat ( ITT ) population . A predefined , modified ITT population ( ie , those in the ITT population with baseline HAM-D₁₇ ≥20 ) was also analyzed . Tolerability was assessed by recording adverse events and change on the Arizona Sexual Experience Scale . RESULTS Baseline HAM-D₁₇ scores for desvenlafaxine ( n = 285 ) and placebo ( n = 142 ) were 22.0 and 21.8 , whereas baseline SDS scores were 19.8 and 20.4 . Adjusted mean differences between desvenlafaxine and placebo were 2.1 ( 95 % confidence interval [ CI ] , 0.78-3.46 ; P = 0.002 ) on the HAM-D₁₇ and 1.3 ( 95 % CI , -0.09 to 2.76 ; P = 0.067 ) on the SDS . For the modified ITT sample , desvenlafaxine ( n = 208 ) and placebo ( n = 102 ) , baseline HAM-D₁₇ scores were 23.8 and 23.9 ; the SDS baseline scores were 20.1 and 20.8 . Mean differences were 2.6 ( 95 % CI , 0.93-4.22 ; P = 0.002 ) on the HAM-D₁₇ and 2.1 ( 95 % CI , 0.36-3.76 ; P = 0.017 ) on the SDS . Adverse events and Arizona Sexual Experience Scale scores were comparable between groups . CONCLUSIONS Desvenlafaxine 50 mg/d was efficacious for treating MDD in gainfully employed adults . Between-group differences on the SDS narrowly missed statistical significance in the ITT population alone , but the totality of data suggests functional improvements with active treatment .

desvenlafaxine

placebo

desvenlafaxine

desvenlafaxine succinate

depressive symptoms and functioning

depressed

major depressive disorder ( MDD )


Event-related potentials and monoamines in autistic children on a clinical trial of fenfluramine . In a double blind , crossover study of the response of autistic subjects to fenfluramine , event-related potentials ( ERPs ) were recorded from 7 subjects on an attention-demanding auditory choice reaction time task ( ACRT ) . ACRT , IQ and biochemical measures were taken after 5 months placebo and 5 months fenfluramine treatment . After fenfluramine treatment blood serotonin levels fell , urinary catecholamine levels fell and the HVA/DA ratio rose . IQ and ACRT performance improved . On the ACRT subjects were asked to press a button to a rare target ( 500 Hz , P = 0.14 ) and to ignore higher pitched rare ( 2,000 Hz , P = 0.14 ) and frequent non-targets ( 1,000 Hz ) . After fenfluramine treatment N1 latencies increased . The scalp distribution of ERP maxima changes slightly with treatment . P3 maxima elicited by rare non-targets were recorded more rostrally after fenfluramine treatment . After rare non-targets N1 amplitudes at Fz decreased but P3 amplitudes at Pz increased . Early negativity after the rare non-target ( particularly on the right side ) was negatively correlated with the HVA/DA ratio . Subtraction of the P3 component elicited in a passive condition where no response was required from the active condition showed that P3 positivity to targets was halved with treatment . ( In contrast Nd increased on fenfluramine treatment ) . Overall , N1 and P3 components showed greatest responsiveness to rare non-targets on fenfluramine . N1 but not P3 changes may represent slight improvement of attention-related function with treatment . Small changes in ERP latency and distribution , associated with the neuroleptic action of fenfluramine may be partly responsible for a mild improvement of IQ and ACRT performance on medication .

fenfluramine .

placebo

fenfluramine treatment .

fenfluramine

fenfluramine

fenfluramine

IQ and ACRT performance

ACRT

N1 latencies

scalp distribution of ERP

N1 amplitudes at Fz

P3 amplitudes at Pz

P3 positivity

autistic

children

autistic


[ Sublingually administered captopril versus nifedipine in hypertension emergencies ] . Aim of the study was to assess the effectiveness and tolerability of sublingual captopril ( SLC ) versus sublingual nifedipine ( SLN ) in treating hypertensive emergencies . During hypertensive crises ( systolic blood pressure exceeding 200 mmHg and diastolic blood pressure exceeding 115 mmHg ) forty hypertensive patients received either 25 mg of SLC or 10 mg of SLN in a randomized single blind fashion . Blood pressure and heart rate were then controlled after 5 , 10 , 15 , 20 , 30 , 45 , 60 , 120 min . and , in 18 cases , up to the 8th hour from the administration . Our results showed : 1 ) a satisfactory control of the hypertensive crises in 80 % of patients treated with SLC with a significant blood pressure reduction after 10 min . ( 13/8 mmHg , p less than 0.02 ) , while the maximum hypotensive effect was achieved after 30 min . ( 52/36 mmHg , p less than 0.001 ) ; SLN was able to reduce blood pressure in 90 % of all the cases , with a significant reduction after 5 min . ( 15/11 mmHg , p less than 0.02 ) and hypotensive peak after 20 min ( 57/38 mmHg , p greater than 0.001 ) ; 2 ) no significant differences for hypotensive effectiveness between the two groups , but with SLC having a mildly delayed onset of action when compared to SLN ; 3 ) antihypertensive effect lasting for about 6 hours in patients treated with SLC and blood pressure progressively raising after 4 hours in patients who received SLN ; 4 ) a significant correlation between blood pressure reduction and blood pressure before drug administration in both groups ; a significant correlation between pretreatment PRA and antihypertensive effect in the SLC group . We conclude that both drugs are effective and useful in treating hypertensive emergencies . Anyway we think that in severe forms SLN should be preferred for the shorter time preceding onset of action .

Sublingually administered captopril

nifedipine

sublingual captopril ( SLC )

sublingual nifedipine ( SLN )

SLN

SLC

SLN

SLC

SLN

SLC

SLN

SLC

SLN

effectiveness and tolerability

Blood pressure and heart rate

control of the hypertensive crises

blood pressure

hypotensive effect

blood pressure

hypotensive peak

hypotensive effectiveness

onset of action

antihypertensive effect

blood pressure

blood pressure

blood pressure

treating hypertensive emergencies

onset of action

hypertension emergencies

hypertensive emergencies

forty

hypertensive

hypertensive emergencies


The relationship between physical activity level , anxiety , depression , and functional ability in children and adolescents with juvenile idiopathic arthritis . The aim of this study was to assess the relationships between physical activity level and anxiety , depression , and functional ability in children and adolescents with juvenile idiopathic arthritis ( JIA ) . Cross-sectional study design including patients with JIA aged between 8 and 17 years and healthy controls was used . Sociodemographic data and clinical features were assessed . Physical activity level and energy expenditure were assessed with a 1-day activity diary . Anxiety was screened by The Screen for Child Anxiety Related Emotional Disorders ( SCARED ) questionnaire . Depressive symptoms were assessed by the Children 's Depression Inventory ( CDI ) . Functional ability was assessed with the Childhood Health Assessment Questionnaire ( CHAQ ) . Pain and overall well-being were measured using a visual analog scale ( VAS ) . Fifty-two patients and 48 controls were included with a mean age of 12.13 ± 2.92 and 11.27 ± 1.59 years , respectively . The mean disease duration was 64 months . The JIA group had significantly less time in physical activity ( p = 0.000 ) , decrease in energy expenditure ( p = 0.04 ) , and higher CHAQ scores ( p = 0.000 ) compared with the control group . In the JIA group , significant relationships were found between the number of active joint and disease duration ( r = 0.44 , p = 0.000 ) and VAS pain ( r = 0.30 , p = 0.02 ) , between SCARED and CDI ( r = 0.54 , p = 0.000 ) . Significant relationships were found between VAS overall well-being and CDI ( r = 0.29 , p = 0.03 ) , CHAQ ( r = 0.37 , p = 0.000 ) , and VAS pain ( r = 0.41 , p = 0.000 ) . Correlation between CHAQ and CDI ( r = 0.34 , p = 0.01 ) was significant . The result of our study suggested that only depression was related to anxiety , functional ability , and well-being in children and adolescents with JIA .

Cross-sectional study

functional ability

physical activity level

anxiety , depression

functional ability

children

adolescents

juvenile idiopathic arthritis

children and adolescents

juvenile idiopathic arthritis ( JIA )

JIA

between 8 and 17 years

Fifty-two

12.13 ± 2.92 and 11.27 ± 1.59 years


Oral S-adenosylmethionine in the symptomatic treatment of intrahepatic cholestasis . A double-blind , placebo-controlled study . Parenteral S-adenosylmethionine proved to be effective in reversing intrahepatic cholestasis in pregnant women . Based on these findings , a prospective multicenter , double-blind , placebo-controlled trial was planned to assess whether oral S-adenosylmethionine is effective in cholestatic patients with chronic liver disease . Accordingly , 220 inpatients ( 26 % chronic active hepatitis , 68 % cirrhosis , 6 % primary biliary cirrhosis ) with stable ( 1 month or more ) at least twofold increases in serum total and conjugated bilirubin and alkaline phosphatase volunteered for the trial . Serum markers of cholestasis significantly ( P less than 0.01 ) decreased after oral S-adenosylmethionine administration ( 1600 mg/day ) , and their values were significantly ( P less than 0.01 ) lower than the corresponding values in the placebo group . S-adenosylmethionine significantly ( P less than 0.01 ) improved subjective symptoms such as pruritus , fatigue , and feeling of being unwell , whereas placebo was ineffective . Two patients in the S-adenosylmethionine group and 9 controls ( P less than 0.05 ) withdrew from the trial for reduced compliance because of inefficacy of treatment . Oral S-adenosylmethionine was tolerated to the same extent as placebo . In conclusion , short-term administration of oral S-adenosylmethionine is more effective than placebo in improving clinical and laboratory measures of intrahepatic cholestasis and offers a new therapeutic modality for the symptomatic management of this syndrome .

Oral S-adenosylmethionine

placebo-controlled

S-adenosylmethionine

oral S-adenosylmethionine

S-adenosylmethionine

S-adenosylmethionine

S-adenosylmethionine

S-adenosylmethionine

oral S-adenosylmethionine

placebo

intrahepatic cholestasis

intrahepatic cholestasis

cholestatic patients

serum total

Serum markers of cholestasis

compliance

inefficacy

tolerated

symptomatic management

intrahepatic cholestasis .


A randomized phase II trial of two regimens of moderate dose chemoradiation therapy for patients with non-small cell lung cancer not suitable for curative therapy : Trans Tasman Radiation Oncology Study TROG 03.07 . BACKGROUND There are patients with stage I-III non-small cell lung cancer ( NSCLC ) who are not suitable for curative radical chemoradiation therapy . There are patients with an isolated solitary extracranial metastasis who have improved outcomes compared with those with cranial or multiple metastases . Patients of good performance status receiving moderate dose radiation therapy have improved survival . Two regimens of moderate dose chemoradiation therapy for such patients were compared in a randomized phase II trial . METHODS Patients were eligible if they had stage I-IIIB NSCLC , unsuitable for curative therapy , or stage IV with a PET-detected extracranial solitary metastasis . Patients were randomized to the following groups-arm A : 40 Gy/20 fractions/4 weeks with concurrent weekly vinorelbine 25 mg/m + cisplatin 20 mg/m or arm B : 30 Gy/15 fractions/3 weeks with concurrent weekly gemcitabine 200 mg. Primary end points were feasibility , response rates , and toxicity . Secondary end points were progression-free survival , overall survival , and quality of life . RESULTS Eighty-four patients were randomized . Compliance was above 90 % for both arms . The overall response rate was 51 % in arm A and 38 % in arm B ( p = 0.147 ) . Grade 3/4 toxicity in both arms was acceptable . There was no difference in median progression-free survival between the two arms ( 5.5 versus 5.0 months , p = 0.19 ) . Patients in arm A had longer median survival but this did not reach statistical significance ( 13.1 versus 8.3 months , p = 0.25 ) . No difference in quality of life was observed . CONCLUSIONS Arm A was chosen for a future phase II comparison with radiation therapy alone as it demonstrated a response rate greater than 50 % , and data suggested that arm A had superior survival to arm B .

chemoradiation therapy

curative radical chemoradiation therapy

radiation therapy

moderate dose chemoradiation therapy

weekly vinorelbine 25 mg/m + cisplatin

weekly gemcitabine 200 mg.

radiation therapy

feasibility

response rates

, and toxicity

quality of life

Compliance

overall response rate

Grade 3/4 toxicity

median progression-free survival

median survival

quality of

life

response

Eighty-four patients were randomized .


Effect of an induction period of pegylated interferon-α2a and ribavirin on early virological response in HIV-HCV-coinfected patients : results from the CORAL-2 study . BACKGROUND It is uncertain whether a 4-week induction period of pegylated interferon and ribavirin increases early virological response ( EVR ) in HIV-HCV-coinfected patients . METHODS HIV and HCV genotype 1- and 4-coinfected subjects were randomized to receive pegylated interferon-α2a 270 μg/week plus ribavirin 1,600 mg daily and epoetin-β for 4 weeks , followed by pegylated interferon-α2a at standard dosages plus weight-based ribavirin ( WBR ) dosage for 8 weeks ( induction arm [ IA ] ) , or pegylated interferon-α2a plus WBR for 12 weeks ( standard therapy arm [ SA ] ) . HCV RNA was determined at weeks 0 , 1 , 2 , 3 , 4 , 8 and 12 . Ribavirin plasma trough concentrations were determined at weeks 4 ( RBV-C ( 4 ) ) and 12 ( RBV-C ( 12 ) ) . RESULTS A total of 67 patients were included ; 33 in the SA and 34 in the IA . Overall , 25 % received nucleoside reverse transcriptase inhibitor ( NRTI ) -sparing regimens . More patients achieved an HCV RNA decrease ≥1 log ( 10 ) at week 4 in the IA than in the SA ( 62 % versus 38 % ; P=0.017 ) , but EVR rates were similar in the two groups ( 74 % versus 59 % in the IA and SA , respectively ; P=0.15 ) . Independent predictors of faster HCV RNA decrease at 12 weeks were higher RBV-C ( 4 ) and younger age . RBV-C ( 4 ) were higher in patients allocated in the IA and in those receiving NRTIs ( P=0.039 ) . CONCLUSIONS A 4-week induction with pegylated interferon-α2a plus ribavirin was associated with a greater decrease in HCV RNA at week 4 ; however , this did not translate into higher EVR rates . Higher RBV doses and avoidance of NRTI-sparing antiretroviral regimens might improve HCV treatment efficacy .

ribavirin


Effects of three oral analgesics on postoperative pain following root canal preparation : a controlled clinical trial . AIM To compare the effects of single doses of three oral medications on postoperative pain following instrumentation of root canals in teeth with irreversible pulpitis . METHODOLOGY In this double-blind clinical trial , 100 patients who had anterior or premolar teeth with irreversible pulpitis without any signs and symptoms of acute or chronic apical periodontitis and moderate to severe pain were divided by balanced block random allocation into four groups of 25 each , a control group receiving a placebo medication , and three experimental groups receiving a single dose of either Tramadol ( 100 mg ) , Novafen ( 325 mg of paracetamol , 200 mg ibuprofen and 40 mg caffeine anhydrous ) or Naproxen ( 500 mg ) immediately after the first appointment where the pulp was removed , and the canals were fully prepared . The intensity of pain was scored based on 10-point VAS before and after treatment for up to 24 h postoperatively . Data were submitted to repeated analysis of variance . RESULTS At the 6 , 12 and 24 h postoperative intervals after drug administration , the intensity of pain was significantly lower in the experimental groups than in the placebo group ( P < 0.01 ) . Tramadol was significantly less effective ( P < 0.05 ) than Naproxen , and Novafen that were similar to each other ( P > 0.05 ) . CONCLUSION A single oral dose of Naproxen , Novafen and Tramadol taken immediately after treatment reduced postoperative pain following pulpectomy and root canal preparation of teeth with irreversible pulpitis .

analgesics

pain

The intensity of pain

10-point VAS

intensity

acute or chronic apical periodontitis


Safety and efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging ( dal-PLAQUE ) : a randomised clinical trial . BACKGROUND Dalcetrapib modulates cholesteryl ester transfer protein ( CETP ) activity to raise high-density lipoprotein cholesterol ( HDL-C ) . After the failure of torcetrapib it was unknown if HDL produced by interaction with CETP had pro-atherogenic or pro-inflammatory properties . dal-PLAQUE is the first multicentre study using novel non-invasive multimodality imaging to assess structural and inflammatory indices of atherosclerosis as primary endpoints . METHODS In this phase 2b , double-blind , multicentre trial , patients ( aged 18-75 years ) with , or with high risk of , coronary heart disease were randomly assigned ( 1:1 ) to dalcetrapib 600 mg/day or placebo for 24 months . Randomisation was done with a computer-generated randomisation code and was stratified by centre . Patients and investigators were masked to treatment . Coprimary endpoints were MRI-assessed indices ( total vessel area , wall area , wall thickness , and normalised wall index [ average carotid ] ) after 24 months and ( 18 ) F-fluorodeoxyglucose ( ( 18 ) F-FDG ) PET/CT assessment of arterial inflammation within an index vessel ( right carotid , left carotid , or ascending thoracic aorta ) after 6 months , with no-harm boundaries established before unblinding of the trial . Analysis was by intention to treat . This trial is registered at ClinicalTrials.gov , NCT00655473 . FINDINGS 189 patients were screened and 130 randomly assigned to placebo ( 66 patients ) or dalcetrapib ( 64 patients ) . For the coprimary MRI and PET/CT endpoints , CIs were below the no-harm boundary or the adverse change was numerically lower in the dalcetrapib group than in the placebo group . MRI-derived change in total vessel area was reduced in patients given dalcetrapib compared with those given placebo after 24 months ; absolute change from baseline relative to placebo was -4·01 mm ( 2 ) ( 90 % CI -7·23 to -0·80 ; nominal p=0·04 ) . The PET/CT measure of index vessel most-diseased-segment target-to-background ratio ( TBR ) was not different between groups , but carotid artery analysis showed a 7 % reduction in most-diseased-segment TBR in the dalcetrapib group compared with the placebo group ( -7·3 [ 90 % CI -13·5 to -0·8 ] ; nominal p=0·07 ) . Dalcetrapib did not increase office blood pressure and the frequency of adverse events was similar between groups . INTERPRETATION Dalcetrapib showed no evidence of a pathological effect related to the arterial wall over 24 months . Moreover , this trial suggests possible beneficial vascular effects of dalcetrapib , including the reduction in total vessel enlargement over 24 months , but long-term safety and clinical outcomes efficacy of dalcetrapib need to be analysed . FUNDING F Hoffmann-La Roche Ltd .

dalcetrapib

Dalcetrapib

dalcetrapib 600 mg/day

placebo

placebo

dalcetrapib

dalcetrapib

dalcetrapib

placebo

MRI-assessed indices

total vessel area

wall area

wall thickness

, and

normalised wall index

MRI-derived change in total vessel area

( aged 18-75 years )

assigned


Randomised multicentre trial of circular stapling devices . PURPOSE In a register study , the risk of anastomotic leakage correlated to the choice of circular stapling device with a 4 % difference between the two brands used . Based on those data , a randomised multicentre study was started to explore the risk of an anastomotic leakage based upon the surgical device . METHODS Patients above 18 years with a rectal cancer , able to give informed consent , and scheduled for an anterior resection were eligible for the study . Perioperative randomisation was to Ethicon™ PROXIMATE™ ILS™ or Autosuture™ Premium Plus CEEA™ . Anastomotic leakage was defined as a clinically manifest leak . RESULTS Five hundred twenty-nine patients were randomised ( 58 % male ) . A leak occurred in 8.3 % . The anastomoses created by PROXIMATE™ ILS™ leaked in 25/265 ( 9.4 % ) anastomoses , and the Premium Plus CEEA™ leaked in 19/260 ( 7.3 % ) , p = .419 . CONCLUSION No difference in the leak rate could be revealed . Several centres replaced one of the staplers by a new product , and the study was ended before the stipulated number of patients was reached . In the future , surgical devices may have to prove superiority in randomised trials or be monitored in quality registers before they can be introduced into day to day surgical practice . The study was registered at ClinicalTrials.gov : NCT00399009 .

circular stapling devices

circular stapling device

surgical device

anastomotic leakage

anastomotic leakage

18 years

rectal cancer

able to give informed consent

scheduled for an anterior resection

leak

Five hundred twenty-nine


The effect of visual supports on performance of the TGMD-2 for children with autism spectrum disorder . The purpose of this study was to examine the effects of visual supports on the performance of the Test of Gross Motor Development ( TGMD-2 ) for children with autism spectrum disorder ( ASD ) . Participants ( N = 22 ) performed the TGMD-2 under three different protocols ( traditional protocol , picture task card protocol , and picture activity schedule protocol ) . Gross motor quotient scores on the TGMD-2 were measured and statistically analyzed using a within-subjects repeated-measures ANOVA . Results indicated statistically significant differences between protocols , while post hoc tests indicated that the picture task card condition produced significantly higher gross motor quotient scores than the traditional protocol and the picture activity schedule . The results suggest that more accurate gross motor quotient scores on the TGMD-2 by children with ASD can be elicited using the picture task card protocol .

traditional protocol

picture task card protocol

picture activity schedule protocol

performance

Gross motor quotient scores

gross motor quotient scores

children

autism spectrum disorder

children

autism spectrum disorder ( ASD )

children

ASD