[ Case-controll study on the synergistic effects of electroacupuncture on knee osteoarthritis after arthroscopic debridement ] . OBJECTIVE To study the synergistic effects of electroacupuncture on the treatment of knee osteoarthritis after arthroscopic debridement . METHODS From May 2008 to July 2010 , 78 patients with knee osteoarthritis were randomly divided into two groups . There were 42 patients in the experimental group , including 16 males and 26 females , ranging in age from 41 to 63 years , with an average of ( 53.62 +/- 6.53 ) years ; the disease course ranged from 8 to 24 months , with an average of ( 10.35 +/- 6.42 ) months . The patients were treated with arthroscopic debridement combined with electroacupuncture after operation . There were 36 patients in the control group , including 14 males and 22 females , ranging in age from 40 to 62 years , with an average of ( 54.34 +/- 7.67 ) years ; the disease course ranged from 6 to 25 months , with an average of ( 11.94 +/- 5.13 ) months . Those patients were treated only with arthroscopic debridment . All the patients performed isometric quadriceps femoris contraction exercise and knee flexion and extension activities after operation . The visual analog scale ( VAS ) score and Lysholm knee score were used to evaluate the therapeutic effects . RESULTS All the patients were followed up , and the duration ranged from 12 to 30 months , with an average of 15.6 months . At the final follow-up , VAS score was significantly decreased , and the Lysholm score , except for the item demanding for support , significantly increased , compared with those before surgery respectively in both groups . There was significant difference in VAS score between two groups after treatment . As to Lysholm score , there were significant differences in limp , pain , swelling , stair activity and squat , but there were no significant differences in items of interlocking and instability between two groups after treatment . CONCLUSION Electroacupuncture can effectively improve the clinical symptoms and knee joint 's motor function of knee joints in patients with knee osteoarthritis , as well as the synergistic effects on the treatment of knee osteoarthritis after arthroscopic debridement , leading to a much better long-term therapeutic effect with respect of improving the function of knee joint . This therapy , combined with traditional Chinese medicine and Western Medicine , is worth of clinical application in the treatment of knee osteoarthritis .

electroacupuncture

arthroscopic debridement

electroacupuncture

arthroscopic debridement

arthroscopic debridement

electroacupuncture

arthroscopic debridment

knee flexion

extension activities

synergistic effects

synergistic effects

disease course

visual analog scale ( VAS ) score and

Lysholm knee score

VAS score

Lysholm score

VAS score

Lysholm score

limp

pain

swelling

stair activity

squat

interlocking

and

instability

clinical symptoms

motor function of knee joints

knee osteoarthritis

males

females

41 to 63

53.62 +/- 6.53

males

females

40 to 62

54.34 +/- 7.67

knee osteoarthritis


The addition of tramadol to the standard of i.v . acetaminophen and morphine infusion for postoperative analgesia in neonates offers no clinical benefit : a randomized placebo-controlled trial . BACKGROUND Tramadol is used following neonatal cardiac and general surgery . However , its ability to opioid-spare or facilitate earlier extubation in postoperative neonates is unquantified . OBJECTIVE This randomized placebo-controlled trial aimed to assess whether tramadol 's addition to standard analgesia resulted in earlier extubation or reduced analgesic/sedative requirements in postsurgical neonates . METHODS Neonates born ≥32 weeks postmenstrual age received either tramadol [ T ] 2 mg·kg ( -1 ) or placebo [ P ] 6-hourly for up to 5 days postthoracoabdominal surgery in addition to morphine ( commenced at 20 mcg·kg ( -1 ) ·h ( -1 ) ) and 6-hourly i.v . acetaminophen . Time to extubation , morphine and midazolam amounts , hourly pain scores , and seizure activity were compared using an intention-to-treat and per-protocol analysis . RESULTS Seventy-one neonates participated . Median survival time to extubation was similar between the groups ( T 67 h [ 95 % CI 51 , 84 ] vs P 52 h [ 95 % CI 43 , 65 ] ; P = 0.4 ) , and similar numbers were extubated by 96 h ( T 69 % vs P 77 % ; difference -8 % , 95 % CI -28 , 13 % ) . Morphine and midazolam exposure was similar , with low pain scores in both groups ( mean percentage of time with a pain score > 5/20 during the 5 days : T 13 % vs P 11 % , difference in means 2.8 [ 95 % CI -1.8 , 7.6 ] , P = 0.20 ) . Most participants had normal cranial ultrasounds ( T 86 % vs P 86 % ) ; no seizures occurred clinically or electroencephalographically . CONCLUSION Tramadol 's addition to standard analgesia in this small group of postsurgical neonates did not appear to have any positive effect on time to extubation , morphine or midazolam exposure , or pain scores . This questions the benefit of tramadol for postsurgical neonates . Importantly , no seizures occurred in these ill neonates who may potentially be at greater risk of tramadol toxicity compared with adults .

tramadol

acetaminophen and morphine

placebo-controlled

Tramadol

tramadol 's

standard analgesia

tramadol

placebo

acetaminophen

Time to extubation

morphine and midazolam amounts

hourly pain scores

seizure activity

participated

Median survival time to extubation

with low pain scores

with a pain score

normal cranial ultrasounds

86 % ) ; no seizures

effect on time to extubation

morphine or midazolam exposure

pain scores

postoperative analgesia in neonates

neonatal cardiac

general surgery .

postsurgical neonates

postthoracoabdominal surgery

Seventy-one

with adults


Examining the temperature of embryo culture in in vitro fertilization : a randomized controlled trial comparing traditional core temperature ( 37°C ) to a more physiologic , cooler temperature ( 36°C ) . OBJECTIVE To determine whether culture at a more physiologically cooler temperature , as suggested by limited human and animal data , would improve blastulation and pregnancy rates in human clinical IVF . DESIGN Paired randomized controlled trial . SETTING Academic . PATIENT ( S ) Infertile couples ( n=52 ) with a female partner less than 42 years old with eight or more mature oocytes retrieved . INTERVENTION ( S ) Mature oocytes obtained from a single cohort of oocytes were randomly divided into two groups ; one was cultured at 37°C and the other at 36°C from the time of ICSI to the time of embryo transfer or vitrification . Paired embryo transfers were accomplished by transferring one euploid embryo from each group . DNA fingerprinting was used as needed to determine the outcome for each embryo . MAIN OUTCOME MEASURE ( S ) Rate of development of expanded blastocysts suitable for transfer or vitrification ( primary outcome ) , fertilization , aneuploidy , and sustained implantation . RESULT ( S ) A total of 805 mature oocytes were cultured ; 399 at 36°C and 406 at 37°C . Paired analysis demonstrated a higher rate of usable blastocyst formation per zygote at 37°C ( 48.4 % ) vs. at 36°C ( 41.2 % ) . Rates of fertilization , aneuploidy , and sustained implantation were equivalent . CONCLUSION ( S ) IVF culture at 36°C does not improve clinically relevant parameters of embryo development or sustained implantation rates . CLINICAL TRIAL REGISTRATION NUMBER NCT01506089 .

cultured at 37°C

in vitro fertilization :


Reducing the psychological distress of family caregivers of home based palliative care patients : longer term effects from a randomised controlled trial . BACKGROUND Palliative care incorporates comprehensive support of family caregivers because many of them experience burden and distress . However , evidence-based support initiatives are few . PURPOSE We evaluated a one-to-one psychoeducational intervention aimed at mitigating the distress of caregivers of patients with advanced cancer receiving home-based palliative care . We hypothesised that caregivers would report decreased distress as assessed by the General Health Questionnaire ( GHQ ) . METHOD A randomised controlled trial comparing two versions of the delivery of the intervention ( one face-to-face home visit plus telephone calls versus two visits ) plus standard care to a control group ( standard care only ) across four sites in Australia . RESULTS Recruitment to the one visit condition was 57 , the two visit condition 93 , and the control 148 . We previously reported non-significant changes in distress between times 1 ( baseline ) and 2 ( 1-week post-intervention ) but significant gains in competence and preparedness . We report here changes in distress between times 1 and 3 ( 8-week post-death ) . There was significantly less worsening in distress between times 1 and 3 in the one visit intervention group than in the control group ; however , no significant difference was found between the two visit intervention and the control group . CONCLUSIONS These results are consistent with the aim of the intervention , and they support existing evidence demonstrating that relatively short psychoeducational interventions can help family caregivers who are supporting a dying relative . The sustained benefit during the bereavement period may also have positive resource implications , which should be the subject of future inquiry .

one-to-one psychoeducational

psychological distress

mitigating the distress of caregivers

distress

competence and preparedness .

distress

worsening in distress

palliative care patients

control


Egg intake during carbohydrate restriction alters peripheral blood mononuclear cell inflammation and cholesterol homeostasis in metabolic syndrome . Egg yolk contains bioactive components that improve plasma inflammatory markers and HDL profiles in metabolic syndrome ( MetS ) under carbohydrate restriction . We further sought to determine whether egg yolk intake affects peripheral blood mononuclear cell ( PBMC ) inflammation and cholesterol homeostasis in MetS , as HDL and its associated lipid transporter ATP-binding cassette transporter A1 ( ABCA1 ) reduce the inflammatory potential of leukocytes through modulation of cellular cholesterol content and distribution . Thirty-seven men and women classified with MetS consumed a moderate carbohydrate-restricted diet ( 25 % -30 % of energy ) for 12 weeks , in addition to consuming either three whole eggs per day ( EGG ) or the equivalent amount of yolk-free egg substitute ( SUB ) . Interestingly , lipopolysaccharide-induced PBMC IL-1β and TNFα secretion increased from baseline to week 12 in the SUB group only , despite increases in PBMC toll-like receptor 4 ( TLR4 ) mRNA expression in the EGG group . Compared to baseline , ABCA1 and 3-hydroxy-3-methyl-glutaryl ( HMG ) -CoA reductase mRNA expression increased by week 12 in the EGG group only , whereas changes in PBMC total cholesterol positively correlated with changes in lipid raft content . Together , these findings suggest that intake of whole eggs during carbohydrate restriction alters PBMC inflammation and cholesterol homeostasis in MetS .

Egg intake

egg yolk intake

moderate carbohydrate-restricted diet

either three whole eggs per day ( EGG

in PBMC total cholesterol

Thirty-seven

men

women

MetS


Intramuscular compared to intravenous midazolam for paediatric sedation : A study on cardiopulmonary safety and effectiveness . BACKGROUND Sedation in children remains a controversial issue in emergency departments ( ED ) . Midazolam , as a benzodiazepine is widely used for procedural sedation among paediatrics . We compared the effectiveness and safety of two forms of midazolam prescription ; intramuscular ( IM ) and intravenous ( IV ) . PATIENTS AND METHODS A cohort study was conducted on two matched groups of 30 children referred to our ED between 2010 and 2011 . The first group received IM midazolam ( 0.3 mg/kg ) and the second group received IV midazolam ( 0.15 mg/kg ) for sedation . For evaluating effectiveness , sedation , irritation and cooperation score were followed every 15 min for 60 min and for safety assessment , vital signs and O 2 saturation were observed . RESULTS Mean age was 6.18 ± 2.88 years and 31 patients ( 51.7 % ) were male . All patients were sedated completely after using first dose . There was an overall complication rate of 68.3 % . 35 ( 58.3 % ) patients presented euphoria as the most common complication , but there was no statistical difference between the two groups ( P = 0.396 ) . Cases who received IV midazolam became sedated faster than those received IM midazolam ( P > 0.001 ) . The vital signs including heart rate , respiratory rate , systolic blood pressure and O 2 saturation changed significantly between and within groups during the sedation ( P < 0.05 ) . CONCLUSION Both forms of midazolam , IM and IV , are effective and safe for paediatric sedation in ED . Although the sedative with IV form might appear sooner , IM form of midazolam can be effectively used in patient with limited IV access . Patients are better to observe closely for psychological side-effects .

Midazolam

benzodiazepine

IM midazolam

IV midazolam

effectiveness

sedation

irritation and cooperation score

were sedated

an overall complication rate

presented euphoria

became sedated

are effective and safe

children

ED between 2010 and 2011

Mean age was 6.18 ± 2.88 years

male


Transcervical Foley 's catheter versus Cook balloon for cervical ripening in stillbirth with a scarred uterus : a randomized controlled trial . OBJECTIVE To compare the efficacy and safety of the use of transcervical Foley 's catheter versus Cook cervical ripening balloon in pregnant women with stillbirth , unfavorable cervix and scarred uterus . DESIGN Randomized controlled study . SETTING El Minia University Hospital , El Minia , Egypt . PATIENTS AND METHODS Two-hundred pregnant women with stillbirth , unfavorable cervix and scarred uterus were recruited into this study . They were randomized into two groups . In group I ( n = 100 ) , cervical ripening was done using Foley 's catheter . In group II ( n = 100 ) , cervical ripening was done using Cook cervical ripening balloon . MAIN OUTCOME MEASURES Balloon insertion to delivery interval , successful ripening rate , cesarean delivery rate , maternal adverse events and maternal satisfaction . RESULTS Time from balloon insertion to expulsion and from balloon insertion to delivery was significantly shorter in Foley 's catheter group . However , the difference between the two groups regarding time from balloon insertion to active labor , time from balloon expulsion to delivery , cervical ripening , cesarean section , instrumental delivery , pain score , need for analgesia , hospital stay and maternal satisfaction was not statistically significant . CONCLUSIONS Foley 's catheter and Cook cervical ripening balloon are comparable regarding efficacy and safety profile when used to ripen the cervix in pregnant women with stillbirth , unfavorable cervix and scarred uterus . However , Foley 's catheter has a shorter induction to delivery interval and is relatively cheaper device .

Transcervical Foley 's catheter

Cook balloon

transcervical Foley 's catheter

Cook cervical ripening balloon

Foley 's catheter

Cook cervical ripening balloon

Foley 's catheter

Cook cervical

efficacy and safety

Balloon insertion to delivery interval

successful ripening rate

cesarean delivery rate

maternal adverse events

maternal satisfaction

balloon insertion to delivery

time from balloon expulsion to delivery

cervical ripening

cesarean section

instrumental delivery

pain score

need for analgesia

hospital stay

maternal satisfaction

efficacy and safety profile

induction to delivery interval

pregnant

women

cervix and scarred uterus

Two-hundred

pregnant

women


Effects of a music therapy group intervention on enhancing social skills in children with autism . BACKGROUND Research indicates that music therapy can improve social behaviors and joint attention in children with Autism Spectrum Disorder ( ASD ) ; however , more research on the use of music therapy interventions for social skills is needed to determine the impact of group music therapy . OBJECTIVE To examine the effects of a music therapy group intervention on eye gaze , joint attention , and communication in children with ASD . METHOD Seventeen children , ages 6 to 9 , with a diagnosis of ASD were randomly assigned to the music therapy group ( MTG ) or the no-music social skills group ( SSG ) . Children participated in ten 50-minute group sessions over a period of 5 weeks . All group sessions were designed to target social skills . The Social Responsiveness Scale ( SRS ) , the Autism Treatment Evaluation Checklist ( ATEC ) , and video analysis of sessions were used to evaluate changes in social behavior . RESULTS There were significant between-group differences for joint attention with peers and eye gaze towards persons , with participants in the MTG demonstrating greater gains . There were no significant between-group differences for initiation of communication , response to communication , or social withdraw/behaviors . There was a significant interaction between time and group for SRS scores , with improvements for the MTG but not the SSG . Scores on the ATEC did not differ over time between the MTG and SSG . CONCLUSIONS The results of this study support further research on the use of music therapy group interventions for social skills in children with ASD . Statistical results demonstrate initial support for the use of music therapy social groups to develop joint attention .

music therapy group intervention

music therapy

music therapy

music therapy group ( MTG )

no-music social skills group ( SSG )

MTG

social skills

social skills

eye gaze

, joint attention , and communication

joint attention with peers and

eye gaze

towards persons

initiation of communication

response to communication

, or

social withdraw/behaviors

SRS scores

Scores on the ATEC

social skills

joint attention

children

autism

children

Autism Spectrum Disorder ( ASD )

children

ASD

Seventeen

children , ages 6 to 9

children

ASD


Prior experience with a pain stimulus as a predictor of placebo analgesia . Placebo effects are important in pain reduction , but the effects are inconsistent . Prior experience with a pain stimulus may moderate placebo analgesia . The current study tests the effect of prior experience with a pain stimulus on placebo analgesia during a laboratory pain task . Healthy normotensive undergraduates ( 66 women , 68 men ) who either did or did not report prior experience with pain from submerging a limb in cold water were enrolled . In the laboratory , an experimenter applied an inert , medicinal-smelling cream to participants ' non-dominant hand . Participants randomized to the no-expectation group were told that the cream was a hand cleanser . Participants randomized to the placebo expectation group were told that the cream would reduce the pain associated with the cold pressor task . Participants then completed the cold pressor task and reported their pain on the short form of the McGill Pain Questionnaire . Analysis of variance revealed a main effect of expectation ( p < .05 ) , such that participants in the placebo expectation group reported less pain . An interaction was also found between expectation and prior experience ( p < .05 ) , such that participants with prior experience with pain from cold water immersion showed no difference in pain reports between expectation groups . In a pain context , prior experience with the pain stimulus may prevent a placebo expectation from reducing the experience of pain .

Placebo

medicinal-smelling cream

cream was a hand cleanser

placebo

cream

cold pressor task

cold pressor task

analgesia

pain reduction

analgesia

placebo analgesia

pain

pain

pain

McGill Pain Questionnaire

less pain

with pain

difference in pain reports

the experience of pain

pain stimulus

undergraduates

women

men

pain stimulus


Contact lens lipid spoliation of hydrogel and silicone hydrogel lenses . PURPOSE The purpose of the study was to measure contact lens lipid spoliation of silicone hydrogel PureVision ( balafilcon A ) and hydrogel Acuvue 2 ( etafilcon A ) contact lenses worn for 10 hours single use ( DD ) and 7 days of extended wear ( EW ) . METHODS Two similar study populations ( DD , n = 55 ; EW , n = 53 ) , were enrolled at four study sites . In each population , a bilateral , randomized , crossover ( lens material ) , subject-masked experimental design was followed . Worn contact lenses were analyzed for lipid uptake using high-performance liquid chromatography by two laboratories : Alcon Laboratories ( right lens total uptake ) and OTG Research & Consultancy ( left lens total uptake and individual lipid classes ) . RESULTS Lipid uptake was different for the two materials : total lipid ( p < 0.007 ) , cholesterol esters ( p < 0.001 ) , cholesterol ( p < 0.001 EW only ) , and triglycerides/phospholipids ( p < 0.001 ) were higher for balafilcon A , whereas fatty acid ( p < 0.0025 EW only ) was higher for etafilcon A . The ratio of the extracted lipids was also different : higher percentages of triglycerides/phospholipids ( p < 0.001 ) and cholesterol ( p < 0.001 EW only ) for balafilcon A and higher percentages of fatty acids/di- and monoglycerides ( p < 0.014 ) for etafilcon A . CONCLUSIONS Total lipid uptake was highly material dependent . Both laboratories measured a greater uptake of lipids by the silicone hydrogel than the hydrogel material , a difference that was evident after only 10 hours of DD . Total lipid uptake was greater after 7 days of EW compared with 10 hours of DD . Of interest for contact lens spoliation and its avoidance was the differential lipid uptake profile , indicating material selectivity . Whereas greater differentiation between materials was possible after 7 days of EW for each material , the lipid uptake profile was similar for DD and EW , indicating a greater material effect than a wear modality effect .

Lipid uptake

total lipid

cholesterol esters

cholesterol

triglycerides/phospholipids

fatty acid

ratio of the extracted lipids

triglycerides/phospholipids

cholesterol

fatty acids/di- and monoglycerides

Total lipid uptake

uptake of lipids

Total lipid uptake

contact lenses

extended wear ( EW )


Complex decongestive therapy and taping for patients with postmastectomy lymphedema : a randomized controlled study . PURPOSE The purpose of our study was to investigate the effects of Kinesio Taping ( ® ) Application with Complex Decongestive Therapy ( CDT ) in patients with lymphedema . MATERIALS AND METHODS 45 patients were randomly divided into 3 groups ( CDT including Bandage , CDT including Bandage + Kinesio Tape ( ® ) , CDT including Kinesio Tape ( ® ) without bandage ) . Assessments included the severity of the symptoms such as pain , discomfort , heaviness , tension , stiffness and weakness . Bilateral circumference measurements were done for evaluation of the edema . RESULTS Symptoms were decreased in all three groups ( p < 0.05 ) . CDT was found effective only during treatment in arm volume ( p < 0.05 ) . Kinesio Taping ( ® ) applied with CDT had effect of decreasing edema after 10 days of treatment period ( p < 0.05 ) and for control period ( p < 0.05 ) . Only the application of Kinesio Taping ( ® ) group also had significant decrease at edema ( p < 0.05 ) . CONCLUSION Kinesio Taping ( ® ) Application along with CDT may have a better effect on decreasing lymphedema which can stimulate the reduction of edema for long term effects .

Complex decongestive therapy

discomfort

heaviness

tension

stiffness

weakness

Bilateral circumference

arm volume

decreasing edema

decrease at edema

decreasing lymphedema

reduction

in patients with lymphedema

METHODS 45 patients

randomly divided into 3 groups

decreasing lymphedema


The effects of low- , medium- , and high-oil distillers dried grains with solubles on growth performance , nutrient digestibility , and fat quality in finishing pigs . A total of 1,480 pigs were used in 3 experiments to determine the effects of corn distillers dried grains with solubles ( DDGS ) varying in oil content on growth performance , carcass traits , and nutrient digestibility in finishing pigs . In Exp . 1 , 1,198 pigs ( PIC Line 337 × 1050 ; initially 46.1 kg ) were allotted to a corn-soybean meal-based diet or diets with 20 or 40 % of a 5.4 % oil DDGS ( 29.5 % CP , 8.9 % ADF , and 21.8 % NDF ; as-fed basis ) or a 9.6 % oil DDGS ( 29.6 % CP , 15.3 % ADF , and 28.6 % NDF ; as-fed basis ) . From d 0 to 82 , ADG was unaffected by DDGS source or level . However , increasing 5.4 % oil DDGS decreased ( linear , P < 0.01 ) G : F , whereas G : F did not change among pigs fed 9.6 % oil DDGS ( DDGS source × level interaction ; P < 0.01 ) . Regardless of DDGS source , carcass yield and HCW decreased ( linear , P < 0.04 ) with increasing DDGS . Increasing DDGS increased jowl iodine value ( IV ) , but the magnitude was greater in pigs fed the 9.6 % oil DDGS compared with those fed 5.4 % oil DDGS ( DDGS source × level interaction ; P < 0.01 ) . In Exp . 2 , 270 pigs ( PIC Line 327 × 1050 ; initially 46.5 kg ) were allotted a corn-soybean meal-based diet or diets with 20 or 40 % of a 9.4 % oil DDGS ( 29.4 % CP , 19.6 % ADF , and 34.5 % NDF ; as-fed basis ) or a 12.1 % oil DDGS ( 28.5 % CP , 17.6 % ADF , and 31.4 % NDF ; as-fed basis ) . From d 0 to 75 , ADG increased and then decreased for pigs fed 9.4 % oil DDGS but was unchanged for pigs fed 12.1 % oil DDGS ( quadratic interaction , P < 0.02 ) . Increasing DDGS increased ( linear , P < 0.01 ) jowl IV and tended ( linear , P < 0.07 ) to increase G : F. Regardless of source , HCW and carcass yield decreased ( linear , P < 0.05 ) as DDGS increased . In Exp . 3 , nutrient digestibility of the 4 DDGS sources was determined using pigs fed either a corn-based basal diet ( 96.6 % corn and 3.4 % vitamins and minerals ) or a DDGS diet with 50 % basal diet and 50 % DDGS . On an as-fed basis , corn contained 3,871 and 3,515 kcal/kg GE and DE , respectively . The 5.4 , 9.6 , 9.4 , and 12.1 % oil DDGS contained 4,347 , 4,648 , 4,723 , and 4,904 kcal/kg ( as-fed basis ) GE and 3,417 , 3,690 , 3,838 , and 3,734 kcal/kg DE , respectively ( as-fed basis ) . Stepwise regression indicated that the oil ( ether extract ) content was the only significant variable to explain differences in energy content . The equations generated to predict DE and NE as a function of oil content on an as-fed basis were DE ( kcal/kg ) = 62.347 × ether extract ( % ) + 3,058.13 ( n = 5 , adjusted R ( 2 ) = 0.41 ) and NE ( kcal/kg ) = 115.011 × ether extract ( % ) + 1,501.01 ( n = 5 , adjusted R ( 2 ) = 0.86 ) .

distillers dried grains with solubles

DDGS

DDGS

increased jowl iodine value ( IV )

source , HCW and carcass yield


A comparison of multiphasic oral contraceptives containing norgestimate or desogestrel in acne treatment : a randomized trial . OBJECTIVE This study aimed to compare the effectiveness and safety of triphasic combined oral contraceptives ( OCs ) containing ethinyl estradiol ( EE ) and norgestimate ( NGM ) and biphasic combined OCs containing EE and desogestrel ( DSG ) in the treatment of mild to moderate acne . STUDY DESIGN This was an investigator-blinded , randomized , parallel group trial conducted at 3 centers in Thailand . Female subjects 18-45 years old were assigned to one or the other OCs and evaluated for efficacy and safety parameters at the baseline visit and after 1 , 3 and 6 months of treatment . RESULTS Among 201 randomized subjects , data from 93 subjects in the EE/NGM group and 95 subjects in the EE/DSG group were analyzed . After 6 months of treatment with EE/NGM and EE/DSG , no differences between formulations were found for the decrease in total acne lesion counts ( 74.4 % vs. 65.1 % , respectively , p=.070 ) or facial improvement score . More women using EE/NGM showed a decrease in severity of facial seborrhea than those using EE/DSG ( p=.005 ) . No changes in weight were noted in either group as compared to baseline . CONCLUSION Multiphasic OCs containing EE/NGM and EE/DSG provided comparable efficacy and tolerability in the treatment of acne . However , EE/NGM had a more beneficial effect on facial seborrhea reduction than EE/DSG . IMPLICATIONS EE/NGM and EE/DSG are multiphasic OCs , which were shown to be clinically equally effective for mild to moderate facial acne , and the multiphasic combined OC with NGM was more effective for women with facial seborrhea . Clinicians may apply the results of this study when considering treatment options for facial acne and seborrhea .

multiphasic oral contraceptives

norgestimate

desogestrel

EE/NGM

EE/DSG

EE/NGM and EE/DSG

EE/NGM

EE/DSG

OCs

EE/NGM and EE/DSG

EE/NGM

EE/DSG

EE/NGM and EE/DSG

multiphasic OCs

acne

decrease in total acne lesion counts

facial improvement score

severity of facial seborrhea

changes in weight

efficacy and tolerability

facial seborrhea


Pharmacokinetics of pregabalin controlled-release in healthy volunteers : effect of food in five single-dose , randomized , clinical pharmacology studies . BACKGROUND The pharmacokinetic properties of the immediate-release ( IR ) and the recently developed controlled-release ( CR ) formulation of pregabalin are dose proportional . Pregabalin IR can be taken with or without food . OBJECTIVES This analysis characterizes the effect of food on pregabalin CR . The objectives of this analysis were : ( 1 ) to evaluate the effect of administration time and fat or caloric content of an accompanying meal on the pharmacokinetic properties of a single dose of pregabalin CR ( 330 mg ) relative to a single dose of pregabalin IR ( 300 mg ) ; ( 2 ) to evaluate the pharmacokinetic properties of a single dose of pregabalin CR administered fasted relative to a single dose of pregabalin CR administered immediately after food ; and ( 3 ) to determine the safety and tolerability of single-dose administration of pregabalin CR and IR with and without food . METHODS The effect of food on the pharmacokinetic properties of pregabalin CR was determined in five phase I , open-label , single-dose , crossover studies ( 24-28 participants/study ) . Caloric and fat content of meals were varied and treatments were administered in the morning , at midday , or in the evening . Blood samples were collected up to 48 h post-dose . Pharmacokinetic parameters were estimated from plasma concentration-time data using standard noncompartmental methods . Adverse events were monitored throughout all studies . RESULTS One hundred and twenty-eight healthy participants ( 19-54 years of age ) received pregabalin . Peak plasma concentrations ( C max ) were lower for CR than the respective pregabalin IR doses , and time to C max occurred later . When pregabalin CR was administered with food at midday or in the evening , total exposures [ area under the plasma concentration-time curve from time zero extrapolated to infinite time ( AUC∞ ) ] were equivalent for pregabalin CR and IR formulations regardless of fat or caloric content . When pregabalin CR was administered with an 800-1,000 calorie medium-fat breakfast , AUC∞ was equivalent for pregabalin CR and IR . Bioequivalence criteria for comparison of pregabalin CR after a low- or medium-calorie breakfast relative to pregabalin IR were not met ; however , bioavailability of the pregabalin CR vs. IR formulation was relatively high ( 75-86 % ) . When pregabalin CR was administered fasted , the AUC∞ was 70-78 % of the AUC∞ of pregabalin CR administered with food and bioequivalence criteria were not met . Additionally , the AUC∞ of the pregabalin CR formulation administered fasted was 62-69 % of that of pregabalin IR administered fasted and bioequivalence criteria were not met . Single-dose pregabalin CR and IR were well tolerated in all studies , with no serious or severe adverse events reported . CONCLUSION Time of day of administration and the fat and caloric content of the accompanying meal had minimal overall effect on the pharmacokinetic properties and bioavailability of the pregabalin CR formulation .

pregabalin

pregabalin

Pregabalin IR

pregabalin CR

pregabalin CR

pregabalin IR

pregabalin CR

pregabalin

pregabalin

pregabalin

studies ( 24-28 participants/study )

( 19-54 years of age )


[ Effect of zero-balanced ultrafiltration and modified ultrafiltration on pulmonary function after cardiac surgery in infants ] . OBJECTIVE To determine the protective effect of zero-balanced ultrafiltration and modified ultrafiltration on infants ' pulmonary function after cardiac surgery . METHODS Sixty infants with congenital heart diseases were randomly divided into 3 groups : a zero-balanced ultrafiltration group ( Z group ) , a modified ultrafiltration group ( M group ) and a zero-balanced ultrafiltration with modified ultrafiltration group ( Z+M group ) . Oxygenation index ( OI ) , difference of alveoli-arterial oxygen pressure ( P ( A-α ) O2 ) , static lung compliance ( Cstat ) , and airway resistance ( Raw ) were measured before caridopulmonary bypass ( CPB , T1 ) , 20 minutes after the CPB ( T2 ) , 2 h after the operation ( T3 ) , 6 h after the operation ( T4 ) and 12 h after the operation ( T5 ) . The time of mechanical ventilation was also monitored . RESULTS After the CPB , OI and Cstat in all groups decreased significantly , while Raw and P ( A-α ) O2 increased significantly . At T3 , T4 and T5 , OI and Cstat in the Z+M group were significantly higher than those in the Z group and the M group ( P < 0.05 ) , Raw and P ( A-α ) O2 in the Z+M group were significantly lower than those in the Z group and the M group ( P < 0.05 ) . The ventilation time in the Z+M group was significantly shorter than that in the Z group and the M group ( P < 0.05 ) . CONCLUSION Zero-balanced ultrafiltration and modified ultrafiltration can effectively promote the pulmonary function after cardiac surgery in infants .

zero-balanced ultrafiltration

modified ultrafiltration

zero-balanced ultrafiltration

modified ultrafiltration

after cardiac surgery

infants

infants '

cardiac surgery

Sixty

infants

congenital heart diseases


Randomized open-label non-comparative multicenter phase II trial of sequential erlotinib and docetaxel versus docetaxel alone in patients with non-small-cell lung cancer after failure of first-line chemotherapy : GFPC 10.02 study . BACKGROUND Concomitant administration of erlotinib with standard chemotherapy does not appear to improve survival among patients with non-small-cell lung cancer ( NSCLC ) , but preliminary studies suggest that sequential administration might be effective . OBJECTIVE To assess the efficacy and tolerability of second-line sequential administration of erlotinib and docetaxel in advanced NSCLC . METHODS In an open-label phase II trial , patients with advanced NSCLC , EGFR wild-type or unknown , PS 0-2 , in whom initial cisplatin-based chemotherapy had failed were randomized to sequential erlotinib 150 mg/d ( day 2-16 ) +docetaxel ( 75 mg/m ( 2 ) d1 ) ( arm ED ) or docetaxel ( 75 mg/m ( 2 ) d1 ) alone ( arm D ) ( 21-day cycle ) . The primary endpoint was the progression-free survival rate at 15 weeks ( PFS 15 ) . Secondary endpoints included PFS , overall survival ( OS ) , the overall response rate ( ORR ) and tolerability . Based on a Simon optimal two-stage design , the ED strategy was rejected if the primary endpoint was below 33/66 patients at the end of the two Simon stages . RESULTS 147 patients were randomized ( median age : 60±8 years , PS 0/1/2 : 44/83/20 patients ; males : 78 % ) . The ED strategy was rejected , with only 18 of 73 patients achieving PFS15 in arm ED at the end of stage 2 and 17 of 74 patients in arm D. In arms ED and D , respectively , median PFS was 2.2 and 2.5 months and median OS was 6.5 and 8.3 months . CONCLUSION Sequential erlotinib and docetaxel was not more effective than docetaxel alone as second-line treatment for advanced NSCLC with wild-type or unknown EGFR status .

erlotinib and docetaxel

docetaxel ( 75 mg/m ( 2 ) d1 ) alone

ED

survival

efficacy and tolerability

progression-free survival rate

PFS

overall survival ( OS ) ,

overall response rate ( ORR

tolerability

non-small-cell lung cancer

non-small-cell lung cancer ( NSCLC )

advanced NSCLC

60±8 years ,

males


Coping strategies as mediators of the effect of the START ( strategies for RelaTives ) intervention on psychological morbidity for family carers of people with dementia in a randomised controlled trial . BACKGROUND Family carers of people with dementia frequently become depressed or anxious . In observational studies , more emotion-focused and less dysfunctional coping predict fewer psychological symptoms , but no randomised controlled trial ( RCT ) has directly investigated emotion-focused coping as mediator of effectiveness of a successful psychological intervention . We hypothesised that emotion-focused coping would mediate the START psychological intervention׳s effects in an RCT . We tested whether mediated effects were moderated by severity of baseline symptoms . METHODS 260 family carers from NHS dementia services were randomised to START ( manualised coping skills intervention ) , or treatment-as-usual ( TAU ) . Blinded raters administered the Hospital Anxiety and Depression Scale ( HADS-T ) and Brief COPE inventory at baseline , 4 and 8 months . HADS-T improved in the intervention group when compared to TAU at all levels of psychological distress . We tested whether coping was a mediator and for moderated mediation , and ( post-hoc ) subgroup treatment effects on coping . RESULTS Data were available for 187 carers ( 71.9 % ) for the mediation analysis . The reduced HADS-T score in the intervention group was mediated by increased emotion-focused coping only among carers with higher ( 16+ ) baseline HADS-T scores ( mediated effect=-0.63 [ -1.11 , -0.15 ] ; proportion of overall effect=33 % [ 3 % , 64 % ] ) . LIMITATIONS We did not measure plausible psychosocial treatment mechanisms other than coping . CONCLUSIONS START benefited family carers both in preventing and treating psychological morbidity , through different mechanisms of action . The most psychologically distressed carers increased their emotion-focused coping and did not decrease their dysfunctional coping , while others benefited but not through this mechanism .

START

dementia

Family carers of people with dementia

dementia


Physical and perceptual cooling with beverages to increase cycle performance in a tropical climate . PURPOSE This study compares the effects of neutral temperature , cold and ice-slush beverages , with and without 0.5 % menthol on cycling performance , core temperature ( Tco ) and stress responses in a tropical climate ( hot and humid conditions ) . METHODS Twelve trained male cyclists/triathletes completed six 20-km exercise trials against the clock in 30.7°C±0.8°C and 78 % ±0.03 % relative humidity . Before and after warm-up , and before exercise and every 5 km during exercise , athletes drank 190 mL of either aromatized ( i.e. , with 0.5 mL of menthol ( 5 gr/L ) ) or a non-aromatized beverage ( neutral temperature : 23°C±0.1°C , cold : 3°C±0.1°C , or ice-slush : -1°C±0.7°C ) . During the trials , heart rate ( HR ) was continuously monitored , whereas core temperature ( Tco ) , thermal comfort ( TC ) , thermal sensation ( TS ) and rate of perceived exertion ( RPE ) were measured before and after warm-up , every 5 km of exercise , and at the end of exercise and after recovery . RESULTS Both the beverage aroma ( P < 0.02 ) and beverage temperature ( P < 0.02 ) had significant and positive effects on performance , which was considerably better with ice-slush than with a neutral temperature beverage , whatever the aroma ( P < 0.002 ) , and with menthol vs non-menthol ( P < 0.02 ) . The best performances were obtained with ice-slush/menthol and cold/menthol , as opposed to neutral/menthol . No differences were noted in HR and Tco between trials . CONCLUSION Cold water or ice-slush with menthol aroma seems to be the most effective beverage for endurance exercise in a tropical climate . Further studies are needed to explore its effects in field competition .

heart


[ Cooperative study of surgical adjuvant chemotherapy of colorectal carcinoma ( second study ) : 3-year survival after surgery of non-curatively resected patients . Cooperative Study Group of Surgical Adjuvant Chemotherapy of Colorectal Cancer in Japan ] . A prospective randomized study was carried out to evaluate the efficacy of surgical adjuvant chemotherapy for non-curatively resected colorectal carcinoma patients as a collaborative study at 428 institutes in Japan from Jan. , 1984 to Dec. , 1985 . A total of 1,138 patients were entered in this study . All patients were divided according to disease location ( colon or rectum ) and received one of two chemotherapeutic regimens after surgery ( Regimen C : MMC 12 mg/m2 i.v . at operation day and 6 mg/m2 in every 2 months +UFT 600 mg/day p.o. , D : the same dose of MMC + UFT 400 mg/day p.o . ) randomly . 556 cases ( colon carcinoma regimen C : 148 , D : 185 cases , rectal carcinoma regimen C : 94 , D : 129 cases ) were evaluable at this presentation . Three-year-survival rate of histologically confirmed non-curatively resected colon carcinoma patients was higher in the group receiving regimen C than in regimen D. But no significant difference was found among the other groups .

surgical adjuvant chemotherapy

surgical adjuvant chemotherapy

chemotherapeutic regimens

( Regimen C : MMC

+UFT

regimen C

regimen D.

Three-year-survival rate

colorectal carcinoma

non-curatively resected

collaborative study


Assessing the benefit of a personalized EHR-generated informed consent in a dental school setting . Informed consents are routinely used as an important source of information to help patients make appropriate clinical decisions . However , current standard consent forms may not accomplish their intended purpose due to the variety of patient literacy and experiences and , in the dental school setting , the developing competence of students . The purpose of this pilot study was to test the efficacy of a personalized informed consent generated through an electronic health record ( EHR ) at one dental school and its role in patient decision making . In the study , a set of informed consents , or SmartConsents , were developed for specific diagnoses and procedures , enhanced with graphics , and delivered through the school 's EHR . Fifty patients were recruited in the school 's Urgent Care Clinic and divided evenly into two groups : one ( control ) receiving the standard consent , with the second receiving a SmartConsent . Following treatment , patients were assessed based on demographics , decisional conflict , satisfaction , health literacy , and knowledge . Overall , there were no significant differences in main effects between SmartConsent and standard informed consents for decisional conflict and satisfaction , although significant differences were identified during secondary analysis of satisfaction , gender , and ethnicity . The study also demonstrated the potential for consents to aid the student provider in better communicating with patients .

SmartConsents

standard consent

SmartConsent

benefit

efficacy

demographics

decisional conflict

satisfaction

health literacy

knowledge

main effects

decisional conflict and satisfaction

satisfaction

gender

ethnicity

better communicating with patients

Fifty


The effects of a course of intranasal oxytocin on social behaviors in youth diagnosed with autism spectrum disorders : a randomized controlled trial . BACKGROUND There is increasing interest in oxytocin as a therapeutic to treat social deficits in autism spectrum disorders ( ASD ) . The aim of this study was to investigate the efficacy of a course of oxytocin nasal spray to improve social behavior in youth with ASD . METHODS In a double-blind , placebo-controlled trial across two Australian university sites between February 2009 and January 2012 , 50 male participants aged between 12 and 18 years , with Autistic or Asperger 's Disorder , were randomized to receive either oxytocin ( n = 26 ) or placebo ( n = 24 ) nasal sprays ( either 18 or 24 International Units ) , administered twice-daily for 8 weeks . Participants were assessed at baseline , after 4- and 8-weeks of treatment , and at 3-month follow-up . Primary outcomes were change in total scores on the caregiver-completed Social Responsiveness Scale and clinician-ratings on the Clinical Global Impressions-Improvement scale . Secondary assessments included caregiver reports of repetitive and other developmental behaviors and social cognition . CLINICAL TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry www.anzctr.org.au ACTRN12609000513213 . RESULTS Participants who received oxytocin showed no benefit following treatment on primary or secondary outcomes . However , caregivers who believed their children received oxytocin reported greater improvements compared to caregivers who believed their child received placebo . Nasal sprays were well tolerated and there was no evidence of increased side effects resulting from oxytocin administration . CONCLUSIONS This is the first evaluation of the efficacy for a course of oxytocin treatment for youth with ASD . Although results did not suggest clinical efficacy , further research is needed to explore alternative delivery methods , earlier age of intervention , and the influence of caregiver expectation on treatment response .

intranasal oxytocin

oxytocin

oxytocin nasal spray

placebo-controlled

oxytocin

placebo

nasal sprays

oxytocin

placebo

oxytocin

oxytocin

tolerated

side effects

youth

autism spectrum disorders

autism spectrum disorders ( ASD ) .

ASD

male

12 and 18 years

Autistic or Asperger 's Disorder


Modelling broilers ' abdominal fat in response to dietary treatments . Neural networks are capable of modelling any complex function and can be used in poultry production . Dietary crude fibre ( CF ) and exogenous enzymes ( exEn ) extensively affected abdominal fat ( AF ) of broilers . Current methods to study AF and its correlation with dietary CF levels and exEn supplements are costly , laborious and time-consuming . The purpose of this study was to develop an artificial neural network-genetic algorithm ( ANN-GA ) to model data on the response of broiler chickens ( AF ) to CF and exEn from 0 to 42 days of age . A data set containing eight treatments was divided to the train , validation , and test data set of the ANN models . The information about feeding eight diets at two periods [ starter ( 0-21 days of age ) and grower ( 22-42 days of age ) ] were used to estimate AF of broilers by ANN-GA. A multilayer feed-forward neural network with different structures was developed using matlab software , and optimal values for the ANN weights were obtained using the genetic algorithm ( GA ) . Crude fibre , and exEn were used as input variables and AF of broilers was output variable . The best model of ANN-GA was determined based on the train root mean square error ( RMSE ) . The best selected ANN-GA showed desirable results , RMSE , 0.1286 % and R ( 2 ) coefficient , 0.876 for test data .

Dietary crude fibre

( CF )

exogenous enzymes

( exEn )

CF

exEn

response of broiler chickens ( AF )


The effect of implementing the Outcome Questionnaire-45.2 feedback system in Norway : A multisite randomized clinical trial in a naturalistic setting . It has been claimed that the monitoring of ongoing psychotherapy is of crucial importance for improving the quality of mental health care . This study investigated the effect of using the Norwegian version of the patient feedback system OQ-Analyst using the Outcome Questionnaire-45.2 . Patients from six psychiatric clinics in Southern Norway ( N = 259 ) were randomized to feedback ( FB ) or no feedback ( NFB ) . The main effect of feedback was statistical significant ( p = .027 ) , corroborating the hypothesis that feedback would improve the quality of services , although the size of the effect was small to moderate ( d = 0.32 ) . The benefits of feedback have to be considered against the costs of implementation .

Outcome Questionnaire-45.2

Outcome Questionnaire-45.2 .

feedback ( FB )

no feedback ( NFB ) .

feedback

feedback

feedback

improve the quality of services

costs of implementation .

multisite

N = 259


That looks familiar : attention allocation to familiar and unfamiliar faces in children with autism spectrum disorder . INTRODUCTION Existing eye-tracking literature has shown that both adults and children with autism spectrum disorders ( ASD ) show fewer and slower fixations on faces . Despite this reduced saliency and processing of other faces , recognition of their own face is reported to be more " typical " in nature . This study uses eye-tracking to explore the typicality of gaze patterns when children with ASD attend their own faces compared to other familiar and unfamiliar faces . METHODS Eye-tracking methodology was used to explore fixation duration and time taken to fixate on the Eye and Mouth regions of familiar , unfamiliar and Self Faces . Twenty-one children with ASD ( 9-16 years ) were compared to typically developing matched groups . RESULTS There were no significant differences between children with ASD and typically matched groups for fixation patterns to the Eye and Mouth areas of all face types ( familiar , unfamiliar and self ) . Correlational analyses showed that attention to the Eye area of unfamiliar and Self Faces was related to socio-communicative ability in children with ASD . CONCLUSIONS Levels of socio-communicative ability in children with ASD were related to gaze patterns on unfamiliar and Self Faces , but not familiar faces . This lack of relationship between ability and attention to familiar faces may indicate that children across the autism spectrum are able to fixate these faces in a similar way . The implications for these findings are discussed .

eye-tracking

eye-tracking

Eye-tracking methodology

fixation duration

unfamiliar and Self Faces

ability and attention

children

autism spectrum disorder

adults

children

autism spectrum disorders ( ASD )

children

ASD

Twenty-one

ASD

9-16 years

children

ASD

children

ASD

children

ASD


A randomized , double-blind , placebo-controlled pilot study of naltrexone to counteract antipsychotic-associated weight gain : proof of concept . Patients with schizophrenia experience higher rates of obesity as well as related morbidity and mortality than the general population does . Women with schizophrenia are at particular risk for antipsychotic-associated weight gain , obesity , and related medical disorders such as diabetes and cardiovascular disease . Given preclinical studies revealing the role of the endogenous opioid systems in human appetite and the potential of antipsychotic medications to interfere with this system , we hypothesized that opioid antagonists may be beneficial in arresting antipsychotic-associated weight gain and promoting further weight loss in women with schizophrenia . In the present study , 24 overweight women with a diagnosis of schizophrenia or schizoaffective disorder were randomized to placebo or naltrexone ( NTX ) 25 mg/d for 8 weeks . The primary outcome measure was a change in body weight from baseline . The patients in the NTX group had significant weight loss ( -3.40 kg ) compared with weight gain ( +1.37 kg ) in the patients in the placebo group . Mainly , nondiabetic subjects lost weight in the NTX arm . These data support the need to further investigate the role of D2 blockade in reducing food reward-based overeating . A larger study addressing the weaknesses of this pilot study is currently underway .

placebo-controlled

naltrexone

placebo

naltrexone

antipsychotic-associated weight gain :

diabetes

cardiovascular disease .

antipsychotic-associated weight gain

weight loss

change in body weight from baseline .

significant weight loss

weight gain

lost weight

food reward-based overeating .

Patients with schizophrenia

Women

schizophrenia

24 overweight

women


Rioprostil , a new prostaglandin E1 analogue , in the once-daily treatment for the prevention of duodenal ulcer recurrence : a comparison with ranitidine . The efficacy of Rioprostil ( a new prostaglandin E1 analogue ) is compared with that of ranitidine in the recurrence prevention of duodenal ulcer ( s ) . Duration of treatment is 6 months . Ninety-seven patients received rioprostil , 600 micrograms once-daily orally , and 110 patients received ranitidine , 150 mg once-daily orally . On rioprostil , 14.9 % of patients showed a relapse after 6 months compared to 10.1 % on ranitidine . Diarrhoea occurred in 7 patients on rioprostil and 3 patients on ranitidine . Rioprostil given 600 micrograms daily in the evening is a highly effective treatment for the prevention of duodenal ulcer relapse , the efficacy not being significantly different from ranitidine 150 mg .

Rioprostil

Rioprostil

ranitidine

ranitidine , 150 mg once-daily orally

rioprostil

ranitidine

rioprostil

ranitidine

Rioprostil

ranitidine

efficacy

relapse

Diarrhoea

efficacy

duodenal ulcer

Ninety-seven


Effects of iron supplements and perinatal factors on fetal hemoglobin disappearance in LBW infants . BACKGROUND The homeostatic mechanisms of iron metabolism and erythropoiesis in infants are unclear . Infants synthesize both fetal hemoglobin ( HbF ) and adult hemoglobin ( HbA ) , and it is not known how the hemoglobin switch is regulated . We hypothesized that iron supplements to infants affect the disappearance of HbF . METHODS We randomized 285 low-birth-weight infants ( 2,000-2,500 g ) into three intervention groups receiving 0 , 1 , or 2 mg/kg/d of iron supplements from 6 wk to 6 mo of age . In the present secondary analysis , we analyzed iron status , total hemoglobin ( Hb ) , and HbF fraction at 6 wk , 12 wk , and at 6 mo and calculated absolute levels of HbF . RESULTS We observed dose-dependent increased levels of Hb in iron-supplemented groups at 6 mo of age . However , for absolute HbF concentration , there was no similar effect of intervention . Mean ( SD ) HbF was 81.2 ( 16.8 ) , 37.0 ( 13.8 ) , and 8.1 ( 5.6 ) g/l at 6 wk , 12 wk , and 6 mo , respectively , similar in all groups . In linear regression analyses , postconceptional age turned out as the major predictor of HbF , independent of gestational age at birth . CONCLUSION Our hypothesis was rejected . Instead , we confirmed a close correlation to postconceptional age , supporting a genetically programmed switch , insensitive to most environmental factors including birth .

iron supplements

levels

intervention .

LBW

infants

low-birth-weight


Safety and effectiveness of bevacizumab-containing treatment for non-small-cell lung cancer : final results of the ARIES observational cohort study . INTRODUCTION Bevacizumab , a recombinant humanized monoclonal antibody against vascular endothelial growth factor , was approved by the US Food and Drug Administration for the treatment of advanced non-small-cell lung cancer ( NSCLC ) in combination with carboplatin and paclitaxel . ARIES ( Avastin Regimens : Investigation of Effectiveness and Safety ) , a prospective observational cohort study , evaluated outcomes in a large , community-based population of patients with first-line NSCLC . METHODS From 2006 to 2009 , ARIES enrolled patients with locally advanced or metastatic NSCLC who were eligible for bevacizumab , excluding those with predominantly squamous histology . Patients were required to provide informed consent and to have initiated bevacizumab with chemotherapy within 4 months before enrollment . There were no protocol-defined treatments or assessments . The dosing of bevacizumab and chemotherapy , and the choice of chemotherapy regimen , was at the discretion of the treating physician . RESULTS ARIES enrolled 1967 patients with first-line NSCLC . At study closure , median follow-up was 12.5 months ( range , 0.2-65.5 ) . Median age was 65 years ( range , 31-93 ) , and 252 patients ( 12.8 % ) identified as never smokers . Median progression-free survival was 6.6 months ( 95 % confidence interval , 6.3-6.9 ) , and median overall survival was 13.0 months ( 95 % confidence interval , 12.2-13.8 ) with first-line bevacizumab plus chemotherapy . Incidences of bevacizumab-associated adverse events ( 19.7 % overall ) were consistent with those in randomized controlled trials of bevacizumab in NSCLC . CONCLUSION Results from ARIES demonstrate similar outcomes to randomized controlled trials of bevacizumab when added to standard chemotherapy in a real-world patient population with advanced NSCLC .

bevacizumab-containing

Bevacizumab

carboplatin

paclitaxel

bevacizumab

bevacizumab

chemotherapy

bevacizumab and chemotherapy

bevacizumab plus chemotherapy

bevacizumab-associated

bevacizumab

bevacizumab

Safety and effectiveness

median follow-up

Median progression-free survival

median overall survival

patients with first-line NSCLC

provide informed consent

with first-line NSCLC


Pathological response and safety of two neoadjuvant strategies with bevacizumab in MRI-defined locally advanced T3 resectable rectal cancer : a randomized , noncomparative phase II study . BACKGROUND In T3 rectal cancer ( RC ) , preoperative chemoradiotherapy [ 5-fluorouracil ( 5-FU-RT ) ] reduces local recurrences , but does not affect overall survival . New therapeutic options are still necessary to improve clinical outcomes . PATIENTS AND METHODS This randomized , noncomparative , open-label , multicenter , two arms , phase II study was conducted in MRI-defined locally advanced T3 resectable RC . In arm A , patients received 12-week bevacizumab plus 5-FU , leucovorin and oxaliplatin ( Folfox-4 ) followed with bevacizumab-5-FU-RT before total mesorectal excision ( TME ) . In arm B , patients received only bevacizumab-5-FU-RT before TME . Primary end point was pathological complete response ( pCR ) rate . RESULTS Forty-six patients were randomized in arm A and 45 patients in arm B . In arm A , the rate of pCR was 23.8 % [ 95 % confidence interval ( CI ) 12.1 % to 39.5 % ] statistically superior to the defined standard rate of 10 % , P = 0.015 . In arm B , the rate of pCR of 11.4 % ( 95 % CI 3.8 % to 24.6 % ) was not different from 10 % , P = 0.906 . No death occurred during the study period , from the start until 8 weeks following surgery . Postoperative fistulas were reported for 16 patients ( 7 in arm A and 9 in arm B ) . CONCLUSION Even if the addition of bevacizumab induced manageable toxicities including an increased risk of postoperative fistula and no treatment-related death , arm B did not achieve the expected pCR rate in the population of patients included . Induction bevacizumab-Folfox-4 followed by bevacizumab-5-FU-RT is promising . It is however necessary to continue investigations in the management of locally advanced RC . CLINICAL TRIALSGOV IDENTIFIER NCT 00865189 .

bevacizumab

bevacizumab-5-FU-RT before TME .


A randomized trial of prophylactic palifermin on gastrointestinal toxicity after intensive induction therapy for acute myeloid leukaemia . Gastrointestinal toxicity , including oral mucositis , is a frequent complication of intensive combination chemotherapy for acute myeloid leukaemia ( AML ) and contributes substantially to treatment-related mortality . We conducted a placebo-controlled randomized trial to evaluate the efficacy of palifermin ( keratinocyte growth factor ) , given at 60 μg/kg per daily IV for 3 d before and after chemotherapy , for mucosal protection in adult patients with previously untreated AML receiving induction therapy with idarubicin , high-dose cytarabine and etoposide . Among 155 randomized patients , there was no statistically significant difference in the rate of grade 3 and 4 oral mucositis ( primary study endpoint ) between the two treatment arms ( three in palifermin arm ( 4 % ) , 8 in placebo arm ( 10 % ; P = 0·21 ) ; however , when considering the severity of oral mucositis ( World Health Organization grade 0-4 ) , there was evidence of reduced rates of higher grades of oral mucositis in the palifermin arm ( P = 0·0007 , test for trend ) . There was a statistically significantly lower rate of grades 3 and 4 gastrointestinal adverse events in the palifermin arm ( 21 % vs. 44 % in placebo arm ; P = 0·003 ) , mainly due to a reduction in severe diarrhoea ( 8 % palifermin , 26 % placebo ; P = 0·01 ) . Palifermin has activity as a mucosal protectant in AML patients receiving intensive chemotherapy . This trial is registered at ACTRN012605000095662 .

prophylactic palifermin

palifermin

acute myeloid leukaemia

adult patients

high-dose cytarabine and etoposide

Among 155 randomized patients


Oxytocin improves behavioural and neural deficits in inferring others ' social emotions in autism . Recent studies have suggested oxytocin 's therapeutic effects on deficits in social communication and interaction in autism spectrum disorder through improvement of emotion recognition with direct emotional cues , such as facial expression and voice prosody . Although difficulty in understanding of others ' social emotions and beliefs under conditions without direct emotional cues also plays an important role in autism spectrum disorder , no study has examined the potential effect of oxytocin on this difficulty . Here , we sequentially conducted both a case-control study and a clinical trial to investigate the potential effects of oxytocin on this difficulty at behavioural and neural levels measured using functional magnetic resonance imaging during a psychological task . This task was modified from the Sally-Anne Task , a well-known first-order false belief task . The task was optimized for investigation of the abilities to infer another person 's social emotions and beliefs distinctively so as to test the hypothesis that oxytocin improves deficit in inferring others ' social emotions rather than beliefs , under conditions without direct emotional cues . In the case-control study , 17 males with autism spectrum disorder showed significant behavioural deficits in inferring others ' social emotions ( P = 0.018 ) but not in inferring others ' beliefs ( P = 0.064 ) compared with 17 typically developing demographically-matched male participants . They also showed significantly less activity in the right anterior insula and posterior superior temporal sulcus during inferring others ' social emotions , and in the dorsomedial prefrontal cortex during inferring others ' beliefs compared with the typically developing participants ( P < 0.001 and cluster size > 10 voxels ) . Then , to investigate potential effects of oxytocin on these behavioural and neural deficits , we conducted a double-blind placebo-controlled crossover within-subject trial for single-dose intranasal administration of 24 IU oxytocin in an independent group of 20 males with autism spectrum disorder . Behaviourally , oxytocin significantly increased the correct rate in inferring others ' social emotions ( P = 0.043 , one-tail ) . At the neural level , the peptide significantly enhanced the originally-diminished brain activity in the right anterior insula during inferring others ' social emotions ( P = 0.004 ) , but not in the dorsomedial prefrontal cortex during inferring others ' beliefs ( P = 0.858 ) . The present findings suggest that oxytocin enhances the ability to understand others ' social emotions that have also required second-order false belief rather than first-order false beliefs under conditions without direct emotional cues in autism spectrum disorder at both the behaviour and neural levels .

Oxytocin

oxytocin 's

oxytocin

oxytocin

oxytocin

oxytocin

placebo-controlled

oxytocin

oxytocin

oxytocin

behavioural and neural deficits

emotion recognition

inferring others ' beliefs

right anterior insula

autism

autism spectrum disorder

autism spectrum disorder

males

autism spectrum disorder

demographically-matched

male

autism spectrum disorder


Use of Transcutaneous Electrical Nerve Stimulation Device in Early Osteoarthritis of the Knee . Some have proposed the use of transcutaneous electrical nerve stimulation ( TENS ) as an adjunct to the current standard of care in treatment of osteoarthritis knee pain . The purpose of this study was to evaluate the effects of TENS on the following issues in patients who have early-stage osteoarthritis of the knee : ( 1 ) pain reduction ; ( 2 ) subjective and ( 3 ) objective functional improvements ; ( 4 ) quality-of-life ( QOL ) measure improvements ; and ( 5 ) isokinetic strength . A prospective , randomized , and single-blinded trial was performed on 23 patients who were randomized to either novel TENS device or standard of care . Metrics analyzed included stair-climb test ; timed-up-and-go test ( TUGT ) ; 2-minute walk test ; 20 times , single leg 6-inch step test ; five-repetition chair-rise test ; active and passive range-of-motion ( ROM ) score ; short form health survey-36 scores ( SF-36 ) score ; Knee Society Score ( KSS ) ; lower extremity functional scale ( LEFS ) ; visual analog scale ( VAS ) ; and isokinetic quadriceps and hamstring strength . In objective functional scores , TENS had significant improvements in TUGT and objective KSS when compared with the matching cohort . Subjective functional and QOL outcomes patients had a significant improvement of their LEFS and SF-36 physical component with the use of TENS brace . The TENS device significantly improved the quadriceps strength when compared with standard therapy . In evaluation for improvement within the TENS cohort , patients had a significant improvement at 3-month follow-up in the TUG test , timed stair-climb test , 20-times single leg , KSS , LEFS , and SF-36 physical component compared to their initial visit . In addition , within the TENS cohort , patients had a significant reduction in pain via VAS at their 3-month follow-up . In conclusion , the use of TENS for 3 months has shown encouraging results to improve pain , function , and QOL in patients with painful osteoarthritic knees , and could positively contribute as an adjunct to current nonoperative treatment of knee arthritis . However , given our small sample size , larger randomized studies are needed to further evaluate these outcomes .

TENS

novel TENS device or standard of care .

Early Osteoarthritis of the Knee .

osteoarthritis knee pain .

23 patients


Angiographic and electrocardiographic parameters of myocardial reperfusion in angioplasty of patients with ST elevation acute myocardial infarction loaded with ticagrelor or clopidogrel ( MICAMI-TICLO trial ) . INTRODUCTION Ticagrelor has been shown to improve outcomes in patients with ACS . However , the effects of this drug on parameters of microvascular flow in patients presenting with ST-segment elevation myocardial infarction ( STEMI ) have not been completely evaluated . METHODS Ninety-two patients presenting with STEMI where randomized to a loading dose of clopidogrel ( 600 mg ) or ticagrelor ( 180 mg ) before undergoing primary angioplasty . We assessed angiographic and electrocardiographic parameters of myocardial reperfusion . Blinded operators calculated angiographic corrected TIMI Frame count ( cTFC ) and myocardial blush grade ( MBG ) before and after stent implantation . ST segment resolution was also measured in all patients . Primary endpoint was cTFC after PCI . Secondary endpoints were cTFC prior to PCI , TIMI flow grade , MBG and the percentage of ST resolution . RESULTS Of the 92 randomized patients , 70 patients were analyzed . Mean age of patients was 58.8±10 years . Patients presented with a mean ischemic time of 4.4±2.6 hours . There were no significant differences in the time between loading dose and stent deployment ( 35.2±36.4 in ticagrelor and 42.7±29.5 min in clopidogrel , p=0.36 ) . cTFC before angioplasty was significantly lower in ticagrelor than in clopidogrel ( 81.1±29.4 vs. 95.1±17.5 frames respectively , p=0.01 ) . After angioplasty there were no differences between ticagrelor and clopidogrel in cTFC ( 24.6±9.3 vs. 27.0±13.4 frames respectively , p=0.62 ) ; MBG grade 3 was present in 76.4 vs. 69.4 % of patients , respectively ( p=0.41 ) . The percentage of ST resolution did not show any differences between groups ( 84.8±23.4 in ticagrelor vs. 70.8±33.7 in clopidogrel , p=0.36 ) . CONCLUSION Compared with clopidogrel , ticagrelor loading in patients presenting with STEMI is not associated with an improvement of angiographic and electrocardiographic parameters of myocardial reperfusion after angioplasty .

ticagrelor

clopidogrel

clopidogrel

ticagrelor

angioplasty

microvascular flow

ST segment resolution

cTFC prior to PCI

TIMI flow grade

mean ischemic time

cTFC

clopidogrel in

The percentage of ST resolution

ACS

myocardial infarction ( STEMI )

Ninety-two

92 randomized patients

70 patients

Mean age of patients was 58.8±10 years


GPs ' experiences with brief intervention for medication-overuse headache : a qualitative study in general practice . BACKGROUND Medication-overuse headache ( MOH ) is common in the general population , and most patients are managed in primary health care . Brief Intervention ( BI ) has been used as a motivational technique for patients with drug and alcohol overuse , and may a have role in the treatment of MOH . AIM To explore GPs ' experiences using BI in the management of patients with MOH . DESIGN AND SETTING Qualitative study in Norwegian general practice . METHOD Data were collected through four focus group interviews with 22 GPs who participated in an intervention study on BI for MOH . Systematic text condensation was used to analyse transcripts from the focus group interviews . RESULTS The GPs experienced challenges when trying to convince patients that the medication they used to treat and prevent headache could cause headache , but labelling MOH as a diagnosis opened up a space for change . GPs were able to use BI within the scope of a regular consultation , and they thought that the structured approach had a potential to change patients ' views about their condition and medication use . Being diagnosed with medication overuse could bring about feelings of guilt in patients , and GPs emphasised that a good alliance with the patient was necessary for successful change using BI to manage MOH . CONCLUSION GPs experience BI as a feasible strategy to treat MOH , and the technique relies on a good alliance between the doctor and patient . When using BI , GPs must be prepared to counter patients ' misconceptions about medication used for headache .

brief intervention

Brief Intervention ( BI )

GPs ' experiences using BI in

BI

GPs experienced

BI

GPs experience BI

BI

guilt

drug and alcohol overuse

Norwegian general practice

22 GPs


Impact of early mobilization on glycemic control and ICU-acquired weakness in critically ill patients who are mechanically ventilated . BACKGROUND ICU-acquired weakness ( ICU-AW ) has immediate and long-term consequences for critically ill patients . Strategies for the prevention of weakness include modification of known risk factors , such as hyperglycemia and immobility . Intensive insulin therapy ( IIT ) has been proposed to prevent critical illness polyneuropathy . However , the effect of insulin and early mobilization on clinically apparent weakness is not well known . METHODS This is a secondary analysis of all patients with mechanical ventilation ( N = 104 ) previously enrolled in a randomized controlled trial of early occupational and physical therapy vs conventional therapy , which evaluated the end point of functional independence . Every patient had IIT and blinded muscle strength testing on hospital discharge to determine the incidence of clinically apparent weakness . The effects of insulin dose and early mobilization on the incidence of ICU-AW were assessed . RESULTS On logistic regression analyses , early mobilization and increasing insulin dose prevented the incidence of ICU-AW ( OR , 0.18 , P = .001 ; OR , 0.001 , P = .011 ; respectively ) independent of known risk factors for weakness . Early mobilization also significantly reduced insulin requirements to achieve similar glycemic goals as compared with control patients ( 0.07 units/kg/d vs 0.2 units/kg/d , P < .001 ) . CONCLUSIONS The duel effect of early mobilization in reducing clinically relevant ICU-AW and promoting euglycemia suggests its potential usefulness as an alternative to IIT .

early mobilization

Intensive insulin therapy

glycemic control

ICU-acquired weakness

ICU-acquired weakness ( ICU-AW )

functional independence .

clinically apparent weakness .

effects of insulin dose

incidence of ICU-AW

incidence of ICU-AW

insulin requirements

achieve similar glycemic goals

clinically relevant ICU-AW

promoting euglycemia

critically ill patients

( N = 104


Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis : patient-reported outcomes from a phase III trial . OBJECTIVE To assess patient-reported outcomes ( PROs ) for tofacitinib , an oral JAK inhibitor for the treatment of rheumatoid arthritis ( RA ) , in a 6-month , phase III , randomized controlled trial . METHODS Patients ages ≥18 years with active RA with an inadequate response to ≥1 tumor necrosis factor inhibitor ( TNFi ) and receiving stable background methotrexate were randomized 2:2:1:1 to tofacitinib 5 mg or 10 mg twice daily , or placebo advanced to tofacitinib 5 mg or 10 mg twice daily at month 3 . PROs measured at month 3 included patient global assessment of disease activity ( PtGA ) , pain , Health Assessment Questionnaire ( HAQ ) disability index ( DI ) , Medical Outcomes Study ( MOS ) Short Form 36 Health Survey version 2 ( SF-36v2 ; acute ) , Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F ) , and MOS Sleep Scale . RESULTS Patients received tofacitinib 5 mg ( n = 133 ) or 10 mg ( n = 134 ) or placebo advanced to tofacitinib 5 mg ( n = 66 ) or 10 mg ( n = 66 ) . HAQ DI ( reported previously ) , PtGA ( P < 0.0001 ) , and SF-36v2 physical and mental component summary ( P < 0.05 ) scores were improved for both tofacitinib doses versus placebo . Furthermore , improvements greater than or equal to the minimum clinically important difference were more frequently reported by tofacitinib-treated patients versus placebo for PtGA ( P < 0.05 ) , pain ( P < 0.0001 ) , HAQ DI ( P < 0.05 ) , SF-36v2 physical and mental component summary scores ( P < 0.05 ) , and FACIT-F ( P < 0.001 for 5 mg twice daily ) . No statistical differences were observed in the MOS Sleep Scale . CONCLUSION Tofacitinib treatment resulted in significant , clinically meaningful improvements in multiple PROs versus placebo over 3 months of treatment in patients with active RA and a previous inadequate response to TNFi .

Tofacitinib with methotrexate

pain

MOS Sleep Scale

for PtGA

0.0001 ) , HAQ

and FACIT-F

daily

No statistical differences

the MOS Sleep Scale

Patients ages ≥18 years


Gene variants in CYP2C19 are associated with altered in vivo bupropion pharmacokinetics but not bupropion-assisted smoking cessation outcomes . Bupropion is used clinically to treat depression and to promote smoking cessation . It is metabolized by CYP2B6 to its active metabolite hydroxybupropion , yet alterations in CYP2B6 activity have little impact on bupropion plasma levels . Furthermore , less than 10 % of a bupropion dose is excreted as urinary bupropion and its characterized metabolites hydroxybupropion , threohydrobupropion , and erythrohydrobupropion , suggesting that alternative metabolic pathways may exist . In vitro data suggested CYP2C19 could metabolize bupropion . The current study investigated the impact of functional CYP2C19 genetic variants on bupropion pharmacokinetics and treatment outcomes . In 42 healthy volunteers , CYP2C19*2 ( a reduced activity allele ) was associated with higher bupropion area under the plasma concentration-time curve ( AUC ) , but similar hydroxybupropion AUC . The mean bupropion AUC was 771 versus 670 hours⋅ng/ml in individuals with and without CYP2C19*2 , respectively ( P = 0.017 ) . CYP2C19*2 was also associated with higher threohydrobupropion and erythrohydrobupropion AUC ( P < 0.005 ) . Adjusting for CYP2B6 genotype did not alter these associations , and CYP2C19 variants did not alter the utility of the hydroxybupropion/bupropion ratio as a measure of CYP2B6 activity . Finally , in a clinical trial of 540 smokers , CYP2C19 genotype was not associated with smoking cessation outcomes , supporting the hypothesis that bupropion response is mediated by hydroxybupropion , which is not altered by CYP2C19 . In conclusion , our study reports the first in vivo evidence that reduced CYP2C19 activity significantly increases the steady-state exposure to bupropion and its reductive metabolites threohydrobupropion and erythrohydrobupropion . These pharmacokinetic changes were not associated with differences in bupropion 's ability to promote smoking cessation in smokers , but may influence the side effects and toxicity associated with bupropion .

bupropion

Bupropion

bupropion

bupropion

bupropion .

bupropion

bupropion plasma levels .

mean bupropion AUC

higher threohydrobupropion

erythrohydrobupropion AUC

the hydroxybupropion/bupropion ratio

smoking cessation outcomes

hydroxybupropion

reduced CYP2C19 activity

the side effects and toxicity

smoking cessation

smokers

smokers


Parent and family outcomes of PEERS : a social skills intervention for adolescents with autism spectrum disorder . Raising a child with an autism spectrum disorder ( ASD ) is associated with increased family chaos and parent distress . Successful long-term treatment outcomes are dependent on healthy systemic functioning , but the family impact of treatment is rarely evaluated . The Program for the Education and Enrichment of Relational Skills ( PEERS ) is a social skills intervention designed for adolescents with high-functioning ASD . This study assessed the impact of PEERS on family chaos , parenting stress , and parenting self-efficacy via a randomized , controlled trial . Results suggested beneficial effects for the experimental group in the domain of family chaos compared to the waitlist control , while parents in the PEERS experimental group also demonstrated increased parenting self-efficacy . These findings highlight adjunctive family system benefits of PEERS intervention and suggest the need for overall better understanding of parent and family outcomes of ASD interventions .

PEERS :

social skills intervention

PEERS

PEERS

PEERS intervention

family impact of treatment

PEERS

family chaos

parenting stress

parenting self-efficacy

family chaos

parenting self-efficacy

Parent and family outcomes

adolescents

autism spectrum disorder

child

autism spectrum disorder ( ASD

parent

adolescents

ASD

parents


The dispatcher assisted resuscitation trial : indirect benefits of emergency research . OBJECTIVE Conduct of emergency research under waiver of consent produces special challenges . Moreover , the act of performing research may have unintended effects , potentially beneficial or detrimental . The Dispatcher-Assisted Randomized Trial ( DART ) was designed to compare 2 types of dispatcher cardiopulmonary ( CPR ) instruction , but not intended to affect the proportion of arrest victims that received bystander CPR . We sought to determine whether odds of receiving bystander CPR were higher during DART than during the periods before and after . METHODS We conducted an observational cohort study of 8626 adults who suffered non-traumatic out-of-hospital cardiac arrest prior to emergency medical services ( EMS ) arrival in greater King County , Washington , between January 1 , 1999 , and December 31 , 2011 . Bystander CPR status was assessed through review of dispatch recordings and EMS reports to classify any bystander CPR ( any B-CPR ) , and further categorized as bystander CPR with or without dispatcher assistance ( DA-CPR and B-CPR , no DA ) . We used multivariable logistic regression to evaluate odds of B-CPR before , during , and after DART . RESULTS The proportions receiving any B-CPR were 52 % before DART ( 1817/3468 ) , 59 % during DART ( 2093/3527 ) , and 54 % after DART ( 885/1631 ) . Compared to the period before DART , odds of receiving any B-CPR were higher during DART ( OR=1.35 , 95 % CI=1.23-1.49 ) , but no different after ( OR=1.10 , 0.98-1.24 ) . Compared to the before period , odds of DA-CPR were higher during DART ( OR=1.79 , 1.59-2.02 ) but no different after ( OR=0.94 , 0.80-1.10 ) . CONCLUSIONS Odds of bystander CPR were higher during the trial , an increase related to higher likelihood of DA-CPR . The finding suggests a possible indirect community-wide benefit due to the interventional trial .

( DA-CPR and B-CPR , no DA ) .

indirect benefits

bystander CPR

Bystander CPR status

bystander CPR ( any B-CPR )

B-CPR

B-CPR

receiving any B-CPR

DA-CPR

Odds of bystander CPR

DA-CPR


The Impact of Pupillary Dilation on Intraocular Pressure and Anterior Segment Morphology in Subjects with and without Pseudoexfoliation . PURPOSE To investigate the change in pre- and post-dilation anterior segment parameters and intraocular pressure ( IOP ) of patients with and without pseudoexfoliation , after topical application of phenylephrine HCl 10 % and tropicamide 1 % . MATERIALS AND METHODS Totally 129 eyes of 129 patients were included in the study . Of the 129 eyes ; 31 had pseudoexfoliation syndrome ( PXS ) , 37 had pseudoexfoliation glaucoma ( PXG ) , 31 eyes were the fellow eyes of subjects with unilateral pseudoexfoliation syndrome ( subclinical PXS ) and 30 eyes were the eyes of subjects without PXS ( controls ) . Patients underwent Pentacam analysis and IOP measurement before and after dilation . The changes in IOP , anterior chamber depth ( ACD ) , anterior chamber volume ( ACV ) , anterior chamber angle ( ACA ) , central corneal thickness ( CCT ) and pupillary diameter ( PD ) were investigated 30 min after the application of mydriatic agents . RESULTS The mean change of IOP in eyes with PXS , in eyes with PXG , in eyes with subclinical PXS and eyes of control subjects were 1.45 ± 2.03 mmhg , 0.27 ± 2.25 mmhg , -0.35 ± 1.58 mmHg and -1.06 ± 1.59mmHg , respectively . Post-dilation IOP values were lower ( p = 0.001 ) in eyes of controls but higher ( p < 0.001 ) in eyes of PXS than the pre-dilation levels . All patients exhibited statistically significant increase in ACD , ACV and PD after the dilation procedure ( p < 0.001 ) . Additionally , post dilation CCT values were significantly lower than pre-dilation values in all groups ; the difference was statistically significant only for eyes with PXG , eyes with subclinical PXS and eyes of controls . CONCLUSION Eyes with PXS had a higher tendency of IOP elevation after pupillary dilation . Eyes with subclinical PXS , however , exhibited a minor increase in IOP , reflecting the asymmetrical character of the disease . Anti-glaucoma medications may have blunted any IOP elevation induced by pupillary dilation in eyes with PXG .

Pupillary Dilation

tropicamide 1 %

mean change of IOP

129 patients

pseudoexfoliation syndrome

pseudoexfoliation glaucoma

unilateral pseudoexfoliation syndrome

without PXS ( controls


Cimetidine as an immunomodulator in the treatment of herpes zoster . As there is evidence of a possible immunoregulatory role for H2-histamine receptor antagonists , we carried out a prospective randomized trial to evaluate the in vivo and in vitro effect of cimetidine , an H2-blocker , in the treatment of herpes zoster infection . Cimetidine treatment shortened the median interval until the first decrease in pain , the median interval until the complete resolution of pain and promoted faster complete healing of skin lesions than symptomatic treatment . The immunological trends observed in vitro support an important role for histamine in the induction of immunosuppression , as measured by the response to the mitogen phytohemagglutinin . This effect of histamine was antagonized by cimetidine .

Cimetidine

H2-histamine receptor antagonists

cimetidine

Cimetidine

cimetidine

faster

complete healing of skin lesions

herpes zoster .


Safety , pharmacokinetics , pharmacogenomics and QT concentration-effect modelling of the SirT1 inhibitor selisistat in healthy volunteers . AIM Selisistat ( SEN0014196 ) , a first-in-class SirT1 inhibitor , is being developed as a disease-modifying therapy for Huntington 's disease . This first-in-human study investigated the safety , pharmacokinetics and pharmacogenomics of single and multiple doses of selisistat in healthy male and female subjects . METHOD In this double-blind , randomized , placebo-controlled study , seven cohorts of eight subjects received a single dose of selisistat at dose levels of 5 , 25 , 75 , 150 , 300 and 600 mg and four cohorts of eight subjects were administered 100 , 200 and 300 mg once daily for 7 days . Blood sampling and safety assessments were conducted throughout the study . RESULTS Selisistat was rapidly absorbed and systemic exposure increased in proportion to dose in the 5-300 mg range . Steady-state plasma concentrations were achieved within 4 days of repeated dosing . The incidence of drug related adverse events showed no correlation with dose level or number of doses received and was comparable with the placebo group . No serious adverse events were reported and no subjects were withdrawn due to adverse events . There were no trends in clinical laboratory parameters or vital signs . No trends in heart rate or ECG parameters , including the QTc interval and T-wave morphology , were observed . There were no findings in physical or neurological examinations or postural control . Transcriptional alteration was observed in peripheral blood . CONCLUSION Selisistat was safe and well tolerated by healthy male and female subjects after single doses up to 600 mg and multiple doses up to 300 mg day ( -1 ) .

SirT1 inhibitor selisistat

Selisistat

selisistat

placebo-controlled

selisistat

Selisistat

placebo

Selisistat

safety assessments

Steady-state plasma concentrations

adverse events

adverse events

heart rate

healthy volunteers .

Huntington 's disease .

male

female

seven cohorts of eight

four

male

female


Recommending self-paced exercise among overweight and obese adults : a randomized pilot study . BACKGROUND National guidelines call for exercise of at least moderate intensity ; however , recommending self-paced exercise may lead to better adherence , particularly among overweight and obese adults . PURPOSE The purpose of this study was to test proof-of-concept for recommending self-paced exercise among overweight adults . METHODS Fifty-nine healthy , low-active ( exercise < 60 min/week ) , overweight ( body mass index 25.0-39.9 ) adults ( 18-65 ) received a 6-month print-based exercise promotion program with the goal of walking 30-60 min/day . Participants were surreptitiously randomly assigned to receive a recommendation for either self-paced ( n = 30 ) or moderate ( 64-76 % maximum heart rate ; n = 29 ) intensity exercise . All participants used electronic diaries and heart rate monitors to track exercise frequency , duration , and intensity . RESULTS The self-paced condition reported more minutes/week of walking ( f ( 2 ) = 0.17 , p = 0.045 ) and a trend toward greater exercise-related energy expenditure/week ( f ( 2 ) = 0.12 , p = 0.243 ) , corresponding to approximately 26 additional minutes/week and 83 additional kilocalories/week over 6 months . CONCLUSIONS Explicit recommendation for self-paced exercise may improve adherence to exercise programs among overweight and obese adults .

self-paced exercise

self-paced exercise

overweight and obese

adults

overweight and obese

adults

Fifty-nine healthy

adults ( 18-65 )

electronic diaries and heart rate

adherence to exercise programs among


Caphosol ( ® ) mouthwash gives no additional protection against oral mucositis compared to cryotherapy alone in stem cell transplantation . A pilot study . PURPOSE To investigate if adding Caphosol ( ® ) , a mouthwash solution , to oral cryotherapy ( OC ) further protects against oral mucositis ( OM ) , a toxic painful complication to high dose chemotherapy . METHOD The study was a randomised , controlled , study design . Patients ≥16 years scheduled for allogeneic stem cell transplantation were included consecutively and randomised to experimental group receiving OC combined with Caphosol ( ® ) ( n = 20 ) or control group receiving OC only ( n = 20 ) . OC was given from start to end of HDCT . Caphosol ( ® ) , from day 0 to day 21 . RESULT There were no significant differences regarding age or gender between the groups . Mucositis was assessed with the World Health Organisation ( WHO ) grading scale . Pain was assessed with a 10 cm visual analogue scale ( VAS ) from 0 = no pain to 10 = worst imaginable pain . Start and duration of therapy with pain relieving drugs , serum C-reactive protein values , and number of days of hospitalisation were collected from the medical records . Data on OM , oral pain , use of i.v . opioids and total parenteral nutrition were collected during 22 days . There was no significant difference between the groups on OM , oral pain , use of i.v . opioids or TPN between the groups . CONCLUSION The study showed no additional effect of combining Caphosol ( ® ) with OC .

Caphosol

cryotherapy

oral cryotherapy

OC

Caphosol

in stem cell transplantation

design

Patients ≥16 years

allogeneic stem cell transplantation

control group


Methylprednisolone in patients with cancer using opioids .

Methylprednisolone

patients with cancer using opioids


Efficacy of rhubarb combined with early enteral nutrition for the treatment of severe acute pancreatitis : a randomized controlled trial . OBJECTIVE To investigate the effect of rhubarb combined with early enteral nutrition ( EEN ) on the gastrointestinal function , disease severity and systemic inflammation in patients with severe acute pancreatitis ( SAP ) . METHODS A total of 126 patients with SAP were randomly assigned into three groups : parenteral nutrition group , treated with standard solution first and EN 14 days later ; EEN group , treated with EN suspension ; or EEN combined with rhubarb group , treated with rhubarb and then EN 2 h later . The gastrointestinal function , APACHE II scores , the levels of plasma IL-6 , IL-11 , C-reactive proteins ( CRP ) and the liver and kidney functional measures were longitudinally analyzed . RESULTS Patients in the EEN/rhubarb group had the shortest period of abdominal pain and the fastest recovery from abnormal bowel movement and high fever as well as significantly shorter periods of intensive-care unit and hospital stays . The combination of EEN and rhubarb significantly reduced the values of APACHE II scores . Combination therapies significantly reduced abnormally higher white blood cell ( WBC ) counts and levels of plasma CRP and IL-6 , but increased the levels of plasma IL-11 . Finally , combination therapies improved the SAP-related damages of liver and kidney function by reducing abnormally higher levels of plasma alanine aminotransferase , aspartate aminotransferase , and creatinine ( Cr ) . CONCLUSION Combination of EEN and rhubarb significantly improved the gastrointestinal function , inhibited systemic inflammation and disease severity and mitigated the disease-related damages of liver and kidney function in SAP patients .

rhubarb

early enteral nutrition

EN suspension

EEN combined with rhubarb group

rhubarb and then EN 2 h later

EEN/rhubarb

EEN and rhubarb

EEN and rhubarb

gastrointestinal function

APACHE II scores

the levels of plasma IL-6 , IL-11

C-reactive proteins ( CRP )

APACHE II scores

white blood cell ( WBC ) counts

levels of plasma CRP

levels of plasma IL-11

liver and kidney function

aspartate aminotransferase

creatinine ( Cr )

126 patients

SAP

SAP


Acute effects of static active or dynamic active stretching on eccentric-exercise-induced hamstring muscle damage . OBJECTIVES To examine whether an acute bout of active or dynamic hamstring-stretching exercises would reduce the amount of muscle damage observed after a strenuous eccentric task and to determine whether the stretching protocols elicit similar responses . DESIGN A randomized controlled clinical trial . METHODS Thirty-six young male students performed 5 min of jogging as a warm-up and were allocated to 1 of 3 groups : 3 min of static active stretching ( SAS ) , 3 min of dynamic active stretching ( DAS ) , or control ( CON ) . All subjects performed eccentric exercise immediately after stretching . Heart rate , core temperature , maximal voluntary isometric contraction , passive hip flexion , passive hamstring stiffness ( PHS ) , plasma creatine kinase activity , and myoglobin were recorded at prestretching , at poststretching , and every day after the eccentric exercises for 5 d. RESULTS After stretching , the change in hip flexion was significantly higher in the SAS ( 5° ) and DAS ( 10.8° ) groups than in the CON ( -4.1° ) group . The change in PHS was significantly higher in the DAS ( 5.6 % ) group than in the CON ( -5.7 % ) and SAS ( -6.7 % ) groups . Furthermore , changes in muscle-damage markers were smaller in the SAS group than in the DAS and CON groups . CONCLUSIONS Prior active stretching could be useful for attenuating the symptoms of muscle damage after eccentric exercise . SAS is recommended over DAS as a stretching protocol in terms of strength , hamstring range of motion , and damage markers .

jogging

control ( CON )

eccentric exercise

stretching

SAS

DAS

CON

DAS

CON

change in hip flexion

Thirty-six

young

male

students

performed 5 min of jogging as a warm-up


Levels of metals in the blood and specific porphyrins in the urine in children with autism spectrum disorders . The aim of the present study was to determine the levels of metals in blood ( zinc ( Zn ) , copper ( Cu ) , aluminium ( Al ) , lead ( Pb ) and mercury ( Hg ) ) , as well as the specific porphyrin levels in the urine of patients with autism spectrum disorder ( ASD ) compared with patients with other neurological disorders . The study was performed in a group of children with ASD ( N = 52 , average age = 6.2 years ) and a control group of children with other neurological disorders ( N = 22 , average age = 6.6 years ) , matched in terms of intellectual abilities ( Mann-Whitney U = 565.0 , p = 0.595 ) . Measurement of metals in blood was performed by atomic absorption spectrometry , while the HPLC method via a fluorescence detector was used to test urinary porphyrin levels . Results were compared across groups using a multivariate analysis of covariance ( MANCOVA ) . In addition , a generalized linear model was used to establish the impact of group membership on the blood Cu/Zn ratio . In terms of blood levels of metals , no significant difference between the groups was found . However , compared to the control group , ASD group had significantly elevated blood Cu/Zn ratio ( Wald χ ( 2 ) = 6.6 , df = 1 , p = 0.010 ) . Additionally , no significant difference between the groups was found in terms of uroporphyrin I , heptacarboxyporphyrin I , hexacarboxyporphyrin and pentacarboxyporphyrin I . However , the levels of coproporphyrin I and coproporphyrin III were lower in the ASD group compared to the controls . Due to observed higher Cu/Zn ratio , it is suggested to test blood levels of Zn and Cu in all autistic children and give them a Zn supplement if needed .

metals in blood ( zinc ( Zn )

copper ( Cu )

aluminium ( Al )

lead ( Pb )

mercury ( Hg )

p = 0.595

Measurement

group membership

blood Cu/Zn ratio

terms of blood levels of metals

had significantly

df = 1 , p = 0.010 )

However , the levels of coproporphyrin

to the controls

higher Cu/Zn ratio

children

autism spectrum disorders

autism spectrum disorder ( ASD )

neurological

children

ASD

N = 52

average age = 6.2 years

children

N = 22

age = 6.6 years


Successful face recognition is associated with increased prefrontal cortex activation in autism spectrum disorder . This study examines whether deficits in visual information processing in autism-spectrum disorder ( ASD ) can be offset by the recruitment of brain structures involved in selective attention . During functional MRI , 12 children with ASD and 19 control participants completed a selective attention one-back task in which images of faces and houses were superimposed . When attending to faces , the ASD group showed increased activation relative to control participants within multiple prefrontal cortex areas , including dorsolateral prefrontal cortex ( DLPFC ) . DLPFC activation in ASD was associated with increased response times for faces . These data suggest that prefrontal cortex activation may represent a compensatory mechanism for diminished visual information processing abilities in ASD .

functional MRI

selective attention one-back task

face recognition

visual information processing

selective attention

activation

prefrontal cortex areas

dorsolateral prefrontal cortex

response times for faces

prefrontal cortex activation

visual information processing abilities

autism spectrum disorder .

autism-spectrum disorder ( ASD )

children

ASD .


Measuring and supporting language function for children with autism : evidence from a randomized control trial of a social-interaction-based therapy . In a report of the effectiveness of MEHRIT , a social-interaction-based intervention for autism , Casenhiser et al . ( Autism 17 ( 2 ) :220-241 , 2013 ) failed to find a significant advantage for language development in the treatment group using standardized language assessments . We present the results from a re-analysis of their results to illustrate the importance of measuring communicative language acts ( formally called " speech acts " ) . Reanalysis confirmed that children in the MEHRIT group outperformed the community treatment group on measures of MLUm , number of utterances produced , and various speech act categories . The study underscores the importance of functional language measures in guiding and evaluating treatment for children with autism , and suggests that MEHRIT is effective in improving children 's use of language during parent-child interactions .

social-interaction-based therapy

MEHRIT

effectiveness

communicative language acts

outperformed

functional language measures

children

autism

autism