Adult height in short children born SGA treated with growth hormone and gonadotropin releasing hormone analog : results of a randomized , dose-response GH trial . CONTEXT GH treatment is effective in improving height in short children born small for gestational age ( SGA ) . GH is thought to have limited effect when started during adolescence . OBJECTIVE The aim of this study was to investigate GH treatment efficacy in short SGA children when treatment was started during adolescence ; to assess whether GH 2 mg/m ( 2 ) · d during puberty improves adult height ( AH ) compared with 1 mg/m ( 2 ) · d ; and to assess whether an additional 2-yr postponement of puberty by GnRH analog ( GnRHa ) improves AH in children who are short at the start of puberty ( < 140 cm ) , with a poor AH expectation . PATIENTS AND DESIGN In this longitudinal , randomized , dose-response GH trial , we included 121 short SGA children ( 60 boys ) at least 8 yr of age . We performed intention-to-treat analyses on all children and uncensored case analyses on 84 children who reached AH . Besides , we evaluated growth during 2 yr of combined GH/GnRHa and subsequent GH treatment until AH in a subgroup of 40 pubertal children with a height of less than 140 cm at the start . RESULTS Short SGA children started treatment at a median age of 11.2 yr , when 46 % had already started puberty . Median height increased from -2.9 at start to -1.7 sd score ( SDS ) at AH ( P < 0.001 ) . Treatment with GH 2 vs. 1 mg/m ( 2 ) · d during puberty resulted in significantly better AH ( P = 0.001 ) , also after correction for gender , age at start , height SDS at start , treatment years before puberty , and target height SDS . AH was similar in children who started puberty at less than 140 cm and received GH/GnRHa , compared with children who started puberty greater than 140 cm and received GH only ( P = 0.795 ) . CONCLUSION When started in adolescence , GH treatment significantly improves AH in short SGA children , particularly with GH 2 mg/m ( 2 ) · d during puberty . When SGA children are short at the start of puberty , they can benefit from combined GH/GnRHa treatment .

growth hormone

gonadotropin releasing hormone analog

GH

GH

GH

GH

efficacy

Adult

children

SGA


Emotion regulation strategies that promote learning : reappraisal enhances children 's memory for educational information . The link between emotion regulation and academic achievement is well documented . Less is known about specific emotion regulation strategies that promote learning . Six- to 13-year-olds ( N = 126 ) viewed a sad film and were instructed to reappraise the importance , reappraise the outcome , or ruminate about the sad events ; another group received no regulation instructions . Children viewed an educational film , and memory for this was later assessed . As predicted , reappraisal strategies more effectively attenuated children 's self-reported emotional processing . Reappraisal enhanced memory for educational details relative to no instructions . Rumination did not lead to differences in memory from the other instructions . Memory benefits of effective instructions were pronounced for children with poorer emotion regulation skill , suggesting the utility of reappraisal in learning contexts .

Emotion regulation strategies

emotion regulation

emotion regulation

; another group received

no regulation instructions

educational film

children 's memory

academic achievement

memory for educational details

memory

Memory benefits

emotion regulation skill

children 's


Irrigation with bupivacaine at the surgical bed for postoperative pain relief after laparoscopic cholecystectomy . PURPOSE The aim of this study was to evaluate the effect of bupivacaine irrigated at the surgical bed on postoperative pain relief in laparoscopic cholecystectomy patients . METHODS This study included 60 patients undergoing elective laparoscopic cholecystectomy who were prospectively randomized into 2 groups . The placebo group ( n=30 ) received 20cc saline without bupivacaine , installed into the gallbladder bed . The bupivacaine group ( n=30 ) received 20cc of 0.5 % bupivacaine in at the same surgical site . Pain was assessed at 0 , 6 , 12 , and 24 hours by using a visual analog scale ( VAS ) . RESULTS A significant difference ( P=.018 ) was observed in pain levels between both groups at 6 hours postoperatively . The average analgesic requirement was lower in the bupivacaine group , but this did not reach statistical significance . CONCLUSIONS In our study , the use of bupivacaine irrigated over the surgical bed was an effective method for reducing pain during the first postoperative hours after laparoscopic cholecystectomy .

bupivacaine

bupivacaine

placebo

saline without bupivacaine

bupivacaine

bupivacaine

bupivacaine

bupivacaine

postoperative pain relief

effect

postoperative pain relief

Pain

pain levels

average analgesic requirement

pain

postoperative pain

laparoscopic cholecystectomy

laparoscopic cholecystectomy

laparoscopic cholecystectomy


Effectiveness and safety of inhaled treprostinil for the treatment of pulmonary arterial hypertension in children . The introduction of prostanoid therapy has revolutionized the treatment of pulmonary arterial hypertension ( PAH ) . However , continuous intravenous prostacyclin infusion poses significant risks and challenges , particularly in children . Inhaled treprostinil has been shown to be safe and efficacious in adults . This study describes the safety and efficacy of inhaled treprostinil in children with PAH . A retrospective analysis of 29 children treated with inhaled treprostinil for ≥6 weeks was performed . Effects of inhaled treprostinil on exercise capacity , functional class , and echocardiographic and hemodynamic data were evaluated . Adverse events were documented . Patients received 3 to 9 breaths ( 6 μg/breath ) of inhaled treprostinil 4 times/day . All were receiving background PAH therapy ; 12 had previously received parenteral prostanoid . Inhaled treprostinil was discontinued in 4 patients because of symptoms including cough and bronchospasm ( n = 3 ) and progression of PAH ( n = 1 ) . Mild side effects including cough ( n = 9 ) and sore throat ( n = 6 ) did not require discontinuation of therapy . World Health Organization functional class improved in 19 and was unchanged in 10 ; exercise capacity significantly improved with the 6-minute walk distance , improving on follow-up from 455.7 ± 71.5 to 498 ± 70 m ( p = 0.01 ) and peak oxygen consumption increasing from 25.5 ± 10.2 to 27.4 ± 10 ( p = 0.04 ) . In conclusion , inhaled treprostinil was associated with improvement in exercise capacity and World Health Organization functional class when added to background targeted PAH therapy in children and had an acceptable safety profile . Based on these early data , further study of inhaled treprostinil appears warranted in pediatric patients with PAH .

treprostinil

prostanoid therapy

prostacyclin

treprostinil

treprostinil

treprostinil

cough and bronchospasm

exercise capacity

peak oxygen consumption

children .

children with PAH .


Comparing the effectiveness of copper intrauterine devices available in Canada . Is FlexiT non-inferior to NovaT when inserted immediately after first-trimester abortion ? Study protocol for a randomized controlled trial . BACKGROUND We describe the rationale and protocol for a randomized noninferiority controlled trial ( RCT ) to determine if the Flexi-T380 ( + ) copper intrauterine contraceptive device ( IUD ) is comparable in terms of effectiveness and expulsion rates to the most common Canadian IUD currently in use , NovaT-200 , when placed immediately after a first-trimester abortion . METHODS/DESIGN Consenting women choosing to use an IUD after an abortion for a pregnancy of less than 12 weeks of gestation will be randomized to device-type groups to receive immediate post-abortion placement of either a Flexi-T380 ( + ) IUD , a device for which no current evidence on expulsion or effectiveness rates is available , or the Nova-T200 IUD , the only other brand of copper IUD available in Canada at the time of study initiation . The primary outcome measure is IUD expulsion rate at 1 year . Secondary outcomes include : pregnancy rate , method continuation rate , complication rates ( infection , perforation ) , and satisfaction with contraceptive method . A non-intervention group of consenting women choosing a range of other post-abortion contraception methods , including no contraception , will be included for comparison of secondary outcomes . Web-based contraception satisfaction questionnaires , clinical records , and government-linked health administrative databases will be used to assess primary and secondary outcomes . DISCUSSION The RCT design , combined with access to clinical records at all provincial abortion clinics , and to information in provincial single-payer linked administrative health databases , birth registry , and hospital records , offers a unique opportunity to determine if a novel IUD has a comparable expulsion rate to that of the current standard IUD in Canada , in addition to the first opportunity to determine pregnancy rate and method satisfaction at 1 year post-abortion for women choosing a range of post-abortion contraceptive options . We highlight considerations of design , implementation , and evaluation of the first trial to provide rigorous evidence for the effectiveness of current Canadian IUDs when inserted after first-trimester abortion . TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT01174225 .

copper intrauterine devices

FlexiT

NovaT

Flexi-T380 ( + ) IUD

Nova-T200 IUD

IUD expulsion rate at 1 year

pregnancy rate

method continuation rate

satisfaction

expulsion rate

pregnancy rate

method satisfaction

first-trimester abortion

women


Interventional study to strengthen the health promoting behaviours of pregnant women to prevent anaemia in southern India . OBJECTIVES to determine the effectiveness of a health information package in terms of empowering the pregnant women to modify their health-care behaviour and take appropriate action to combat anaemia in pregnancy . DESIGN the study was conceptualized based on Rosenstock and Becker 's health belief model . A quasi-experimental pretest-posttest control group design was used . The sample consists of 225 anaemic pregnant women randomly allocated in experimental ( n=75 ) , control group A ( n=75 ) and control group B ( n=75 ) . The health seeking behaviour outcome measure included knowledge regarding anaemia , food selection ability , increase in haemoglobin level and compliance to iron supplementation . Intervention was a validated planned educational programme with visual aids and iron supplementation . FINDINGS the results show the mean gain of knowledge scores of experimental group was comparatively higher and control groups A and B showed that F ratio was ( F ( 2,190 ) =11.910 , p < 0.01 ) indicating that the pregnant women learned more about anaemia prevention than others . With regard to food selection ability scores of experimental , control groups A and B the F ratio was also significant ( F ( 2,190 ) =20.92 , p < 0.01 ) . Nearly 61.2 % of the subjects in experimental group became non-anaemic after the intervention when compared to control group A . This indicated that inspite of iron supplementation received by the three groups health education contributed significantly in modifying their health seeking behaviour and their perception about significance of anaemia has a problem . CONCLUSION developing countries still face the critical problem of anaemia in pregnancy . These are the socio-cultural priority problems that demand immediate attention by the policy makers and health professionals . The national anaemia control programme focuses on iron supplementation , but nutritional education and supervision of iron supplementation has failed in different regions . The study implies that economic empowerment ; strengthening health literacy through planned educational programs will definitely improve the health behaviour of individual and community at large .

health information package

control

control

iron supplementation

mean gain of knowledge scores

non-anaemic

women

southern India


Efficacy and safety of bexarotene combined with psoralen-ultraviolet A ( PUVA ) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides : final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial ( NCT00056056 ) . BACKGROUND Psoralen plus ultraviolet A ( PUVA ) is the standard treatment for early stages of mycosis fungoides . There have been no adequate randomized controlled trials with sufficient power comparing this modality with other therapies . OBJECTIVE To assess disease response and to compare the response rates of patients treated with PUVA alone or PUVA and bexarotene . METHODS EORTC 21011 ( NCT 00056056 ) was a randomized phase III study comparing combined bexarotene ( Targretin ( ® ) ) and PUVA vs. PUVA alone in patients with stage IB and IIA mycosis fungoides ( MF ) . The primary endpoint was the overall response rate [ complete clinical response ( CCR ) plus partial response ( PR ) ] . RESULTS The study was prematurely closed due to low accrual after 93 of 145 required patients ( 65 % ) were randomized . Of the 93 randomized patients , 87 started treatment , 41 received PUVA and 46 received PUVA + bexarotene . Total UVA doses received were 107 J cm ( -2 ) ( range 1·4-489·9 ) in the PUVA arm vs. 101·7 J cm ( -2 ) ( 0·2-529·9 ) in the combination arm . The safety profile was acceptable with few grade 3-4 toxicities observed in either arm . More drop-outs due to toxicity were observed in the combination arm compared with the PUVA-alone arm . The best overall response ( CCR + PR ) rate was 71 % for PUVA alone and 77 % for the combination arm ( P = 0·57 ) . The median duration of response was 9·7 months for PUVA vs. 5·8 months for the combination arm ( P = 0·33 ) . CCR was seen in 25 patients of whom 10 received PUVA alone ( CCR 22 % ) and 15 received combination therapy ( CCR 31 % ) ( P = 0·45 ) . CCR was sustained in 25 % of patients regardless of therapy . There was a trend towards fewer PUVA sessions needed to achieve CCR in the combination arm ( median 22 ) compared with the PUVA arm ( median 27·5 ) ( P = 0·11 ) . Similarly , a trend towards lower UVA dose required to achieve CCR in the combination arm ( median 55·8 J cm ( -2 ) ) compared with the PUVA arm alone ( median 117·5 J cm ( -2 ) ) ( P = 0·5 ) was observed . CONCLUSIONS No significant difference in response rate or response duration was observed in this study . However , there was a trend towards fewer PUVA sessions and lower UVA dose required to achieve CCR in the combination arm ( PUVA + bexarotene ) but this did not achieve statistical significance due to insufficient power .

bexarotene combined with

psoralen-ultraviolet A

( PUVA )

PUVA treatment alone

Psoralen plus ultraviolet A ( PUVA )

PUVA alone

PUVA and bexarotene

Efficacy and safety

disease response

response rates

Cutaneous Lymphoma

mycosis fungoides


A comparison between oral ciprofloxacin and intra-peritoneal vancomycin and gentamicin in the treatment of CAPD peritonitis . Fifty-one patients were included in a prospective , randomized comparison of oral ciprofloxacin and intraperitoneal vancomycin/gentamicin in the treatment of CAPD peritonitis . Staphylococcal species accounted for 40 % of the isolates with an equal incidence of Staphylococcus aureus and coagulase negative staphylococci . Although , overall , there was no significant difference between the regimens in outcome , ciprofloxacin was significantly less effective when peritonitis was due to coagulase negative staphylococci .

ciprofloxacin

intra-peritoneal vancomycin

gentamicin

oral ciprofloxacin

intraperitoneal vancomycin/gentamicin

ciprofloxacin

CAPD peritonitis

Staphylococcus aureus

coagulase negative staphylococci

effective

CAPD peritonitis

Fifty-one patients


Computer-delivered tailored intervention improves colon cancer screening knowledge and health beliefs of African-Americans . We conducted a randomized controlled trial among African-American patients attending a primary-care provider visit to compare efficacy of a computer-delivered tailored intervention to increase colorectal cancer ( CRC ) screening ( n = 273 ) with non-tailored print material-an American Cancer Society brochure on CRC screening ( n = 283 ) . Health Belief Model constructs were used to develop tailored messages and examined as outcomes . Analysis of covariance models were used to compare changes between CRC knowledge and health belief scores at baseline and 1 week post-intervention . At 1 week , patients who received the computer-delivered tailored intervention had greater changes in CRC knowledge scores ( P < 0.001 ) , perceived CRC risk scores ( P = 0.005 ) , FOBT barriers scores ( P = 0.034 ) and colonoscopy benefit scores ( P < 0.001 ) . Findings show that computer-delivered tailored interventions are an effective adjunct to the clinical encounter that can improve knowledge and health beliefs about CRC screening , necessary precursors to behavior change .

non-tailored print material-an

colon cancer screening knowledge

colorectal cancer ( CRC ) screening

CRC knowledge and health belief scores

CRC knowledge scores ( P < 0.001 )

perceived CRC risk scores ( P = 0.005 )

FOBT barriers scores ( P = 0.034 )


Psychological adjustment and levels of self esteem in children with visual-motor integration difficulties influences the results of a randomized intervention trial . This study evaluates how much the effects of intervention programs are influenced by pre-existing psychological adjustment and self-esteem levels in kindergarten and first grade children with poor visual-motor integration skills , from low socioeconomic backgrounds . One hundred and sixteen mainstream kindergarten and first-grade children , from low socioeconomic backgrounds , scoring below the 25th percentile on a measure of visual-motor integration ( VMI ) were recruited and randomly divided into two parallel intervention groups . One intervention group received directive visual-motor intervention ( DVMI ) , while the second intervention group received a non-directive supportive intervention ( NDSI ) . Tests were administered to evaluate visual-motor integration skills outcome . Children with higher baseline measures of psychological adjustment and self-esteem responded better in NDSI while children with lower baseline performance on psychological adjustment and self-esteem responded better in DVMI . This study suggests that children from low socioeconomic backgrounds with low VMI performance scores will benefit more from intervention programs if clinicians choose the type of intervention according to baseline psychological adjustment and self-esteem measures .

Psychological adjustment

self esteem

NDSI

DVMI


Working well with a disability : health promotion as a means to employment . PURPOSE/OBJECTIVE The purpose of this study was to test the utility of the Working Well with a Disability health-promotion program with vocational rehabilitation ( VR ) clients . Health-promotion interventions have been shown to reduce limitation from secondary conditions , which can be a significant barrier to labor force participation among people with disabilities . The state and federal VR system represents a potential access point for delivery of health-promotion activities . RESEARCH METHOD/DESIGN A total of 297 VR clients participated in a randomized trial of the Working Well health promotion program . Control and intervention participants provided baseline and four waves of quarterly follow-up data . Data were analyzed with repeated-measures ANOVA . RESULTS Intervention-group participants who attended over half of the Working Well sessions reported significantly lower rates of limitation from secondary conditions over the 1-year study span , F ( 1 , 124 ) = 4.11 , p = .004 . Control-group participants also experienced significantly lower rates of limitation , but pre- to postdifferences were less dramatic , F ( 1 , 308 ) = 4.19 , p = .006 . CONCLUSIONS/IMPLICATIONS Overall , health data indicated that the Working Well program may be particularly helpful to VR clients with higher rates of secondary health conditions and may represent one strategy for overcoming barriers to employment .

health promotion

vocational rehabilitation

Health-promotion interventions

Working Well health promotion program

Working Well

Control-group

Working Well program

lower rates of limitation

overcoming barriers to employment


A prospective , randomized , double dummy , placebo-controlled trial of oral cefditoren pivoxil 400mg once daily as switch therapy after intravenous ceftriaxone in the treatment of acute pyelonephritis . OBJECTIVES To compare the clinical and bacteriological effectiveness of intravenous ( IV ) ceftriaxone followed by oral cefditoren pivoxil or IV ceftriaxone for acute pyelonephritis . METHODS A prospective randomized controlled trial of patients with a presumptive diagnosis of acute pyelonephritis was performed . Daily 2g IV ceftriaxone was initially given to all patients . After day 3 , patients who satisfied the criteria for switch therapy were randomized to either group A ( IV ceftriaxone ) or group B ( oral cefditoren pivoxil 400mg once daily ) . RESULTS Eighty-two patients were enrolled ; 41 ( 50 % ) patients in group A and 41 ( 50 % ) patients in group B were evaluated . There was no statistically significant difference in baseline characteristics between the two groups . Clinical cure was observed in 39 of 41 ( 95.1 % ) patients in group A and 41 of 41 ( 100 % ) patients in group B ( p=0.15 , 95 % confidence interval ( CI ) -0.12 to 0.02 ) . Urine bacteriological eradication was found in 63.4 % in group A and 60 % in group B ( p=0.75 , 95 % CI -0.18 to 0.25 ) . There was no statistically significant difference in adverse effects between the two treatment groups . CONCLUSION These data suggest that IV ceftriaxone followed by oral cefditoren pivoxil is highly effective and well-tolerated for the treatment of acute pyelonephritis , even for uropathogens with a high proportion of quinolone-resistant strains .

cefditoren pivoxil

ceftriaxone

cefditoren pivoxil

IV ceftriaxone

2g IV ceftriaxone

IV ceftriaxone

oral cefditoren pivoxil 400mg

ceftriaxone

cefditoren pivoxil

bacteriological effectiveness

baseline characteristics

Clinical cure

Urine bacteriological eradication

adverse effects

effective

well-tolerated

acute pyelonephritis

Eighty-two


The prognostic value of testicular biopsy in childhood acute lymphoblastic leukemia : a report from the Childrens Cancer Study Group . One of the objectives of Childrens Cancer Study Group ( CCSG ) study 141 ( CCG-141 ) was to determine the frequency of occult testicular leukemia ( TL ) after 3 years of disease-free survival ( DFS ) and to retreat boys with occult TL to prolong their subsequent DFS . Of the 494 boys entered on study , 255 ( 51.6 % ) were in complete continuous remission ( CCR ) 3 years after entering remission and an additional eight were in CCR 3 years after localized extramedullary relapse and retreatment ; 263 boys were eligible for testicular biopsy . Elective testicular biopsy was performed on 235 ( 89.4 % ) boys . Of the 204 ( 86.8 % ) boys with negative biopsies , 175 ( 85.8 % ) remained in CCR 10 to 12 years after diagnosis and 25 ( 12.3 % ) relapsed , 11 ( 44 % ) of whom died . Isolated overt TL occurred in four ( 2.0 % ) and all remained in CCR 22+ to 60+ months after re-treatment . Of the 26 boys with occult TL , 16 ( 62 % ) remained in CCR . Ten ( 38 % ) relapsed despite local testicular irradiation and systemic re-treatment ; six of the 10 died . Of the 26 boys who did not undergo biopsy , 21 ( 80.8 % ) remained in CCR ; two ( 7.7 % ) developed isolated overt TL . DFS after testicular biopsy was significantly better in boys without occult TL ( P = .001 ) . Occult TL after 3 years of CCR represents aggressive minimal-residual disease and carries a worse prognosis than absence of TL . Initial treatment should be directed at obviating occult and overt testicular relapse . Conventional therapy as used in this study was suboptimal in preventing subsequent bone marrow ( BM ) relapse and death . If occult TR is identified during or at the end of planned therapy , a higher salvage rate may require intensified alternate therapy . As such , testicular biopsies may be clinically useful . Further investigation is limited by the relative rarity of , and the lack of identifying features in boys with occult TL .

testicular biopsy

testicular biopsy

testicular biopsy

local testicular irradiation

systemic re-treatment

biopsy

testicular biopsy

testicular biopsies

occult testicular leukemia ( TL )

disease-free survival ( DFS )

relapsed

died

developed isolated overt TL

DFS after testicular biopsy

bone marrow ( BM ) relapse

death

higher salvage rate


Mindfulness-based therapy in adults with an autism spectrum disorder : a randomized controlled trial . Research shows that depression and anxiety disorders are the most common psychiatric concern in autism spectrum disorders ( ASD ) . Mindfulness-based therapy ( MBT ) has been found effective in reducing anxiety and depression symptoms , however research in autism is limited . Therefore , we examined the effects of a modified MBT protocol ( MBT-AS ) in high-functioning adults with ASD . 42 participants were randomized into a 9-week MBT-AS training or a wait-list control group . Results showed a significant reduction in depression , anxiety and rumination in the intervention group , as opposed to the control group . Furthermore , positive affect increased in the intervention group , but not in the control group . Concluding , the present study is the first controlled trial to demonstrate that adults with ASD can benefit from MBT-AS .

Mindfulness-based therapy

Mindfulness-based therapy ( MBT )

modified MBT protocol ( MBT-AS )

MBT-AS training

wait-list control

group

MBT-AS .

anxiety

depression symptoms

depression

anxiety

rumination

positive affect

adults

with an autism spectrum disorder :

high-functioning

adults

ASD

adults


Preschool based JASPER intervention in minimally verbal children with autism : pilot RCT . In this pilot study , we tested the effects of a novel intervention ( JASPER , Joint Attention Symbolic Play Engagement and Regulation ) on 3 to 5 year old , minimally verbal children with autism who were attending a non-public preschool . Participants were randomized to a control group ( treatment as usual , 30 h of ABA-based therapy per week ) or a treatment group ( substitution of 30 min of JASPER treatment , twice weekly during their regular program ) . A baseline of 12 weeks in which no changes were noted in core deficits was followed by 12 weeks of intervention for children randomized to the JASPER treatment . Participants in the treatment group demonstrated greater play diversity on a standardized assessment . Effects also generalized to the classroom , where participants in the treatment group initiated more gestures and spent less time unengaged . These results provide further support that even brief , targeted interventions on joint attention and play can improve core deficits in minimally verbal children with ASD .

JASPER intervention

core deficits

play diversity


Clinical efficacy of antazoline in rapid cardioversion of paroxysmal atrial fibrillation -- a protocol of a single center , randomized , double-blind , placebo-controlled study ( the AnPAF Study ) . BACKGROUND Rapid conversion of atrial fibrillation ( AF ) to sinus rhythm may be achieved by the administration of class IA , IC and III antiarrhythmic drugs or vernakalant hydrochloride . However , that treatment may be related to potential pro-arrhythmia , lack of efficacy or the exceptionally high cost of a compound used . Antazoline is a first generation antihistaminic agent with chinidin-like properties . When administered intravenously , antazoline exerts a strong antiarrhythmic effect on supraventricular arrhythmia , especially on AF , facilitating rapid conversion to sinus rhythm . Despite a relative lack of published data antazoline has been marketed in Poland and widely used in cardiology wards and emergency rooms for many years due to its efficacy , safety and rapid onset of action within minutes of administration . METHODS/DESIGN A randomized , double blind , placebo-controlled , superiority clinical trial was designed to assess clinical efficacy of antazoline in rapid conversion of AF to sinus rhythm . Eligible patients will present AF lasting less than 43 hours , will be in stable cardio-pulmonary condition and will have no prior history of advanced heart failure or significant valvular disease . Long-term antiarrhythmic therapy is not considered an exclusion criterion . Subjects who fulfill selection criteria will be randomly assigned to receive intravenously either antazoline or placebo in divided doses and observed for 1.5 hours after conversion to sinus rhythm or after the last i.v . bolus . Primary end point will be the conversion of AF to sinus rhythm confirmed in an electrocardiogram ( ECG ) during the observation period . Secondary end points will be comprised of time to conversion and return of AF during the observation period . Special consideration will be given to the observation of any adverse events . A sample size of 80 patients was calculated based on the following assumptions : two-tailed test , a type I error of 0.01 , a power of 90 % , efficacy of placebo 5 % , efficacy of antazoline 50 % and 20 % drop-out rate to fulfill the criteria of intention-to-treat analysis . Due to the presumed lack of statistical power , the secondary end points and safety endpoints will be considered exploratory . CLINICAL TRIALS REGISTRY ClinicalTrials.gov , NCT01527279 .

antazoline

vernakalant hydrochloride

Antazoline

antazoline

placebo-controlled

antazoline

antazoline

placebo

placebo

antazoline

strong antiarrhythmic effect

supraventricular arrhythmia

AF

rapid conversion to sinus rhythm

clinical efficacy

adverse events .

efficacy

paroxysmal atrial fibrillation -- a


[ Clinical efficiency of cytokines in prophylactics and treatment of infectious and inflammatory complications after oral surgery procedures ] . The study presents the results of prevention and treatment of infectious and inflammatory complications after oral surgery procedures . Combined therapy with antibiotics and superlimf promotes a more rapid reduction in the duration of clinical symptoms and duration of treatment than monotherapy with antibiotics . Results of the study substantiate the feasibility of using superlimf in outpatient oral surgical procedures for infectious and inflammatory complications treatment .

cytokines

monotherapy

with antibiotics

superlimf

reduction

oral surgery


Effects of self-directed stress management training and home-based exercise on stress management skills in cancer patients receiving chemotherapy . Although exercise may be used by some to decrease distress , little is known about how it may contribute to stress management ( SM ) among patients receiving chemotherapy . We evaluated whether exercise separately or in combination with SM training is effective at increasing perceived ability to manage stress . Patients receiving chemotherapy ( N = 391 ) were randomized to receive usual care only ( UCO ) , SM , exercise ( EX ) , or stress management and exercise ( SMEX ) . They completed the Measure of Current Status prior to receiving chemotherapy and 12 weeks after the first infusion . We hypothesized that participants randomized to an intervention condition would report improvements in relaxation , awareness of tension , getting needs met and coping confidence compared with those receiving UCO . Results indicated significant group-by-time interactions for the following : relaxation ( UCO versus SM , p = 0.008 ) , awareness of tension ( UCO versus SMEX , p = 0.029 and UCO versus EX , p < 0.001 ) , getting needs met ( UCO versus SMEX , p = 0.020 ) and Measure of Current Status total score ( UCO versus SMEX , p = 0.007 and UCO versus EX , p = 0.016 ) . There were no group-by-time interactions for coping confidence ( p-values > 0.05 ) . This study provides support for including an exercise component in SM interventions for cancer patients receiving chemotherapy ( clinicaltrials.gov identifier : NCT00740038 ) .

chemotherapy

stress management skills

relaxation

awareness of tension

getting needs met

coping confidence

relaxation

awareness of tension

getting needs met

Current Status

coping confidence

exercise component

cancer

receiving chemotherapy

N = 391

cancer


Take a walk in the park ? A cross-over pilot trial comparing brisk walking in two different environments : park and urban . OBJECTIVE The objective of the present study is to investigate whether differences exist between a 30 minute brisk walk taken in two different environments in order to determine which environment best facilitates current physical activity guidelines : park or urban . METHODS In this randomised cross-over pilot study , participants performed a self-timed 30 minute brisk walk in two different environments , park and urban , in Glasgow , Scotland ( October 2009 to January 2010 ) . Cadence , recorded using the activPAL™ activity monitor , was used to measure intensity . Outcome measures were : mean cadence ; moderate-to-vigorous physical activity time accumulated in bouts lasting ≥ 10 min ; number of walking breaks ; and duration . RESULTS A convenience sample of 40 healthy adults was recruited : 16 males , 24 females , mean age 22.9 ( 5.5 ) years . The mean cadence for the whole walk was higher in the park : 119.3 ( 8.3 ) vs. 110.9 ( 8.9 ) steps/min . Participants accumulated more moderate-to-vigorous physical activity in ≥ 10 minute bouts during park walks : 25.5 ( 9.6 ) [ median ( interquartile range ) ] vs. 14.0 ( 20.3 ) min . There was no difference in self-timed duration between locations . CONCLUSION Participants accumulated more moderate-to-vigorous physical activity in bouts ≥ 10 min in duration on park walks due to the lack of interruptions in walking . Hence the park environment better facilitated the achievement of current physical activity guidelines . Further research involving a larger , more heterogeneous sample is recommended .

30 minute brisk walk

Cadence

brisk walk

healthy

adults

16 males

24 females

mean age 22.9 ( 5.5 ) years


Randomized trial of partial vs. stepwise caries removal : 3-year follow-up . This randomized , multicenter clinical trial evaluated the effectiveness of 2 treatments for deep caries lesions - partial caries removal ( PCR ) and stepwise excavation ( SW ) - with respect to the primary outcome of pulp vitality for a 3-year follow-up period . Inclusion criteria were as follows : patients with permanent molars presenting deep caries lesions ( lesion affecting ≥ 1/2 of the dentin on radiographic examination ) , positive response to a cold test , absence of spontaneous pain , negative sensitivity to percussion , and absence of periapical lesions ( radiographic examination ) . Teeth randomly assigned to PCR ( test ) received incomplete caries removal and filling in a single session . Outcome success was evaluated by assessment of pulp vitality , determined by pulp sensitivity to a cold test and the absence of periapical lesions . Data were analyzed by a Weibull regression model with shared frailty term ( survival analysis ) . At baseline , 299 treatments were executed : PCR , 152 and SW , 147 . By the end of the 3-year follow-up period , 213 teeth had been evaluated . Adjusted survival rates were 91 % for PCR and 69 % for SW ( p = 0.004 ) . These results suggest that there is no need to re-open a cavity and perform a second excavation for pulp vitality to be preserved ( Clinical trials registration NCT00887952 ) .

partial

stepwise

caries

deep caries lesions


Manuka honey-impregnated dressings in the treatment of neuropathic diabetic foot ulcers . In this study , we investigate the effect of manuka honey-impregnated dressings ( MHID ) on the healing of neuropathic diabetic foot ulcers ( NDFU ) . A total of 63 Caucasians , type 2 diabetic patients followed up in the diabetic foot outpatient clinic comprised the study population . Patients were randomised in two groups as follows : group I patients were treated with MHID and group II patients were treated with conventional dressings ( CD ) . The patients were followed up on a weekly basis for 16 weeks . Mean healing time was 31 ± 4 days in group I versus 43 ± 3 days in group II ( P < 0·05 ) . In group I patients 78·13 % of ulcers became sterile during the first week versus 35·5 % in group II patients ; the corresponding percentages for weeks 2 , 4 and 6 were 15·62 % versus 38·7 % , 6·25 % versus 12·9 % and 0 % versus 12·9 % respectively . The percent of ulcers healed did not differ significantly between groups ( 97 % for MHID and 90 % for CD ) . MHID represent an effective treatment for NDFU leading to a significant reduction in the time of healing and rapid disinfection of ulcers .

Manuka honey-impregnated dressings

MHID

conventional dressings ( CD )

neuropathic diabetic foot ulcers .

63 Caucasians

type 2 diabetic patients


Junctional ectopic tachycardia after congenital heart surgery in the current surgical era . To determine the incidence of postoperative junctional ectopic tachycardia ( JET ) in a modern cohort of pediatric patients , evaluate possible risk factors for JET , and examine the effects of JET on postoperative morbidity and mortality . JET is common after congenital heart surgery . JET-related mortality has been a rare event at our center , which is different from previous reports . We reviewed records for pediatric patients who had postoperative arrhythmias between January 2006 and June 2010 at a large tertiary-care children 's hospital . We performed a matched case-control study to identify risk factors for JET and a matched-cohort study to compare outcomes between patients and controls . Whenever possible , each JET case was randomly matched to two controls on the basis of lesion , repair , and surgical period . We identified 54 patients with JET ( incidence = 1.4 % ) . After multivariate logistic regression analysis , low operative weight , cardiopulmonary bypass ( CPB ) duration > 100 min , and immediate postoperative serum lactic acid level > 20 mg/dl were associated with increased odds of developing JET . Patients with JET had longer mechanical ventilation time , cardiac intensive care unit ( CICU ) stay , and hospital stay . There was only one death in JET group ( 1.8 % ) with no significant difference compared with the control group . JET remains a relatively common postoperative arrhythmia , but it is less frequent than previously reported . JET occurs more commonly in smaller patients with longer CPB runs and significant postoperative lactic acidosis levels . Mortality associated with JET is lower than historically reported , but morbidity remains high .

junctional ectopic tachycardia

JET

Junctional ectopic tachycardia

risk factors for JET

effects of JET

postoperative morbidity and mortality .

death

postoperative arrhythmia

postoperative lactic acidosis levels .

Mortality

morbidity

modern cohort of pediatric patients

postoperative arrhythmias

children 's hospital

54 patients

Patients with JET


Hyperbaric oxygen in the treatment of childhood autism : a randomised controlled trial . BACKGROUND Promising results with hyperbaric therapy for children with autism have been reported , but most involved the use of only mild pressure with oxygen supplementation . To date , there has been no randomised , blinded trial of 100 % oxygen administered at hyperbaric pressure . This study evaluated the efficacy of hyperbaric oxygen therapy ( HBOT ) . METHODS Sixty Thai children with autism , aged three to nine years , were randomly assigned to receive 20 one-hour sessions of either HBOT at 153 kPa ( 1.5 ATA ) or sham air at 116 kPa ( 1.15 ATA ) . Effects on behaviour were measured using the Autism Treatment Evaluation Checklist score ( ATEC ) and clinical improvement was measured with the Clinical Global Impression ( CGI ) system ; in particular the clinical change ( CGIC ) and severity ( CGIS ) sub-scores . These were evaluated by parents and clinicians , both of whom were blinded to the actual exposure . RESULTS The mean total ATEC scores by both parents and clinicians were significantly improved after intervention in both arms of the study compared to the score before intervention ( P < 0.001 in both groups by parents , P = 0.015 in HBOT group and P = 0.004 in sham group by clinician ) . There were no statistically significant differences in average percentage changes of total ATEC score and all subscales scores when comparing the HBOT and sham air groups , either by parents or clinicians . Changes in the CGI scores following intervention were inconsistent between parents and clinicians . For severity scores ( CGIS ) , parents rated their children as more improved following HBOT ( P = 0.005 ) , while the clinicians found no significant differences ( P = 0.10 ) . On the other hand , for change scores ( CGIC ) the clinicians indicated greater improvement following HBOT ( P = 0.03 ) , but the parents found no such difference ( P = 0.28 ) . CONCLUSIONS Children with autism who received 20 sessions of either HBOT or a sham air exposure had significant improvements in overall behaviour but there were no significant differences in improvement between groups . The inconsistent changes on CGI sub-scores between parents and clinicians are difficult to interpret , but no overall clinically significant benefit from HBOT could be shown . Both interventions were safe and well tolerated with minimal side effect from middle ear barotraumas .

Hyperbaric oxygen

hyperbaric therapy

sham air at 116 kPa

HBOT

efficacy

Effects on behaviour

clinical improvement

mean total ATEC scores

total ATEC score

CGI scores

severity scores ( CGIS )

change scores ( CGIC )

overall behaviour

CGI sub-scores

safe and well tolerated

minimal side effect


A randomised group comparison controlled trial of 'preschoolers with autism ' : a parent education and skills training intervention for young children with autistic disorder . AIM To determine the effect of parent education on adaptive behaviour , autism symptoms and cognitive/language skills of young children with autistic disorder . METHOD A randomised group comparison design involving a parent education and counselling intervention and a parent education and behaviour management intervention to control for parent skills training and a control sample . Two rural and two metropolitan regions were randomly allocated to intervention groups ( n = 70 ) or control ( n = 35 ) . Parents from autism assessment services in the intervention regions were randomly allocated to parent education and behaviour management ( n = 35 ) or parent education and counselling ( n = 35 ) . RESULTS Parent education and behaviour management resulted in significant improvement in adaptive behaviour and autism symptoms at 6 months follow-up for children with greater delays in adaptive behaviour . Parent education and behaviour management was superior to parent education and counselling . We conclude that a 20-week parent education programme including skills training for parents of young children with autistic disorder provides significant improvements in child adaptive behaviour and symptoms of autism for low-functioning children .

control sample

intervention

control

or parent education and counselling

adaptive behaviour

autism symptoms

cognitive/language skills

adaptive behaviour

autism symptoms

adaptive behaviour

child adaptive behaviour

symptoms of autism


Airway responses and inflammation in subjects with asthma after four days of repeated high-single-dose allergen challenge . BACKGROUND Both standard and low-dose allergen provocations are an established tool in asthma research to improve our understanding of the pathophysiological mechanism of allergic asthma . However , clinical symptoms are less likely to be induced . Therefore , we designed a protocol for repetitive high-dose bronchial allergen challenges to generate clinical symptoms and airway inflammation . METHODS A total of 27 patients aged 18 to 40 years with positive skin-prick tests and mild asthma underwent repetitive high-dose allergen challenges with household dust mites for four consecutive days . Pulmonary function and exhaled NO were measured at every visit . Induced sputum was analysed before and after the allergen challenges for cell counts , ECP , IL-5 , INF-γ , IL-8 , and the transcription factor Foxp3 . RESULTS We found a significant decrease in pulmonary function , an increased use of salbutamol and the development of a late asthmatic response and bronchial hyperresponsiveness , as well as a significant induction of eNO , eosinophils , and Th-2 cytokines . Repeated provocation was feasible in the majority of patients . Two subjects had severe adverse events requiring prednisolone to cope with nocturnal asthma symptoms . CONCLUSIONS Repeated high-dose bronchial allergen challenges resulted in severe asthma symptoms and marked Th-2-mediated allergic airway inflammation . The high-dose challenge model is suitable only in an attenuated form in diseased volunteers for proof-of-concept studies and in clinical settings to reduce the risk of severe asthma exacerbations . TRIAL REGISTRATION ClinicalTrials.govNCT00677209 .

Airway responses and inflammation

Pulmonary function

exhaled NO

Induced sputum


Duration of untreated negative and positive symptoms of psychosis and cognitive impairment in first episode psychosis . BACKGROUND Duration of untreated psychosis ( DUP ) has been significantly associated with poor clinical and social outcomes in First Episode Psychosis ( FEP ) patients , but an association with cognitive outcomes has not been clearly established . METHOD Seventy-seven consecutively admitted , drug-naïve patients with FEP were assessed at baseline and at 1month and 6months . Underlying dimensions of DUP ( general prodrome and positive , negative and disorganisation symptoms ) were assessed using the Symptom Onset in Schizophrenia ( SOS ) inventory ( Perkins et al. , 2000 ) . To assess the effect of DUP on the neuropsychological status of the patients , a linear mixed-effect model was fitted to each neuropsychological dimension . These models included a dichotomised version of DUP ( short versus long duration ) as a fixed effect , several adjusting variables to account for patient differences , and a random effect to incorporate the longitudinal structure of the data . RESULTS Patients with a short duration of untreated negative symptoms ( DUNS ) or a short duration of untreated positive symptoms ( DUPS ) outperformed patients with a long duration of untreated symptoms on memory tasks and a pre-attentional visual task but not on measures of verbal fluency , attention , reaction time , visual processing and executive functions . CONCLUSIONS This study provides additional support for an early intervention to shorten DUP to facilitate a better outcome in memory and attentional domains of FEP patients .

poor clinical and social outcomes

psychosis

first episode psychosis

Seventy-seven


Memantine as adjunctive treatment to risperidone in children with autistic disorder : a randomized , double-blind , placebo-controlled trial . Autism is a neurodevelopmental disorder that causes significant impairment in socialization and communication . It is also associated with ritualistic and stereotypical behaviour . Recent studies propose both hyper-and hypoglutamatergic ideologies for autism . The objective of this study was to assess the effects of memantine plus risperidone in the treatment of children with autism . Children with autism were randomly allocated to risperidone plus memantine or placebo plus risperidone for a 10-wk , double-blind , placebo-controlled study . The dose of risperidone was titrated up to 3 mg/d and memantine was titrated to 20 mg/d . Children were assessed at baseline and after 2 , 4 , 6 , 8 and 10 wk of starting medication protocol . The primary outcome measure was the irritability subscale of Aberrant Behavior Checklist-Community ( ABC-C ) . Difference between the two treatment arms was significant as the group that received memantine had greater reduction in ABC-C subscale scores for irritability , stereotypic behaviour and hyperactivity . Eight side-effects were observed over the trial , out of the 25 side-effects that the checklist included . The difference between the two groups in the frequency of side-effects was not significant . The present study suggests that memantine may be a potential adjunctive treatment strategy for autism and it was generally well tolerated . This trial is registered with the Iranian Clinical Trials Registry ( IRCT1138901151556N10 ; www.irct.ir ) .

Memantine

risperidone

placebo-controlled

memantine plus risperidone

risperidone plus memantine

placebo plus risperidone

risperidone

autistic disorder

children

autism

autism


The role of nasal IgA in children vaccinated with live attenuated influenza vaccine . BACKGROUND Immunoglobulin A ( IgA ) is the predominant antibody produced in response to mucosal infections . The role of IgA in providing protection against influenza in children vaccinated with live attenuated influenza vaccine ( LAIV ) has not been well described . METHODS Nasal IgA responses were assessed using data from 3 prospective , 2-year , randomized studies comparing LAIV with placebo in children 6-36 months of age . In each study , samples were collected in a subset of patients ; a new cohort was enrolled each year . Ratios of strain-specific nasal IgA to total nasal IgA were calculated and prevaccination to postvaccination geometric mean fold-rises ( GMFRs ) were evaluated . Mean postvaccination IgA ratios were compared for subjects with and without confirmed influenza illness by study and in pooled analyses . RESULTS Across studies , a higher percentage of children receiving LAIV had a ≥ 2-fold increase in strain-specific IgA ratio compared with placebo recipients . GMFRs after LAIV in years 1 and 2 ranged from 1.2 to 6.2 , compared with 0.5-2.2 among placebo recipients . Similar responses were observed in subjects who were baseline seronegative and seropositive based on serum hemagglutination inhibition antibody titers . In years 1 and 2 , the mean postvaccination strain-specific to total IgA ratio was 3.1-fold ( P < 0.01 ) and 2.0-fold ( P < 0.03 ) higher among LAIV recipients with no evidence of culture-confirmed influenza illness compared with LAIV recipients who developed culture-confirmed influenza illness ; a similar and consistent trend was observed for each individual study and type/subtype . CONCLUSIONS The current analysis demonstrates that nasal IgA contributes to the efficacy of LAIV and can provide evidence of vaccine-induced immunity . However , the inherent heterogeneity in nasal antibody levels and variability in nasal specimen collection hinders the precise evaluation of mucosal antibody responses . Other studies have demonstrated that LAIV-induced immunity is also partially explained by T-cell immunity , serum antibody responses , and innate immunity , consistent with the multi-faceted nature of immunity induced by wild-type influenza infection and other live virus vaccines .

nasal IgA

Immunoglobulin A ( IgA

IgA

placebo

nasal IgA

IgA

LAIV

geometric mean fold-rises ( GMFRs )

Mean postvaccination IgA ratios


Iron in relation to gastric cancer in the Alpha-tocopherol , Beta-carotene Cancer Prevention Study . BACKGROUND Iron is an essential micronutrient that can have carcinogenic effects when at high or low concentrations . Previous studies of iron in relation to gastric cancer have not assessed subtype-specific relationships . We used the prospective Alpha-Tocopherol , Beta-Carotene ( ATBC ) Cancer Prevention Study to assess whether iron metrics were associated with gastric cardia cancer ( GCC ) and gastric noncardia cancer ( GNCC ) . METHODS We selected 341 incident gastric cancer cases ( 86 cardia , 172 noncardia , and 83 nonspecified ) , accrued during 22 years of follow-up , and 341 individually matched controls . We measured prediagnostic serum iron , ferritin , unsaturated iron binding capacity , and C-reactive protein . Total iron-binding capacity ( TIBC ) and transferrin saturation were estimated from these metrics . Dietary iron exposures were estimated from a food frequency questionnaire . Multivariable logistic regression was used for analysis . RESULTS Serum iron metrics were not associated with GCC , except for a potential " n " -shaped relationship with TIBC ( global P = 0.038 ) . GNCC was inversely associated with serum ferritin ( global P = 0.024 ) , serum iron ( global P = 0.060 ) and , possibly , transferrin saturation . TIBC appeared to share a " u " -shaped relationship with GNCC ( global P = 0.033 ) . Dietary iron exposures were not associated with either subsite . Adjustment for Helicobacter pylori and gastric atrophy had little effect on observed associations . CONCLUSIONS We found little evidence for the involvement of iron exposure in the pathogenesis of GCC . GNCC was associated with an iron profile similar to that of iron deficiency . IMPACT Our findings indicate that inverse associations between iron metrics and gastric cancer are driven by associations with GNCC . Further elucidation of potential mechanisms is warranted .

Iron

Iron

Dietary iron

iron

iron

iron

carcinogenic effects

gastric cardia cancer ( GCC )

gastric noncardia cancer

( GNCC )

Total iron-binding capacity ( TIBC )

Serum iron metrics

GCC

GNCC

serum ferritin

serum iron

transferrin saturation

TIBC

GNCC

Dietary iron exposures

GCC

GNCC

gastric cancer

gastric cardia cancer

GCC

gastric noncardia cancer

GNCC

gastric cancer

cardia

noncardia

GNCC


Improving RBC K transport and hemoglobin-O2 binding by amiloride : A novel therapeutic approach for reversion of angina and myocardial ischemia in coronary heart diseases . UNLABELLED Coronary heart disease ( CHD ) is the leading cause of morbidity and mortality across the entire world , in which reversion of angina or improvement of ECG remains an unrealistic therapeutic option for most patients , suggesting that microvascular dysfunction or impaired oxygen delivery might be critical factors in CHD . This research article , thus presents the rationale basis , clinical and experimental , for the first therapeutic innovation addressing the role of red blood cell ( RBC ) H/K and O2/CO2 exchanges in CHD . It is followed by a randomized single-blind trial of Amiloride and Optimal Medical Therapy ( OMT , n=35 cases ) vs OMT alone ( n=35 cases ) in patients having angina , ST-T alteration and a defective RBC-K transport . All patients had serial clinical evaluation , Ion Transport Studies , ECGs and non-invasive aortic waveform and cardiovascular hemodynamic recordings . Statistical analysis was performed by SAS . RESULTS Amiloride rapidly improved RBC-K ( 93.5 ±4 vs 84.5 ±4 mmol/lc , p= < 0.001 ) , angina ( 80 % of cases , 1.5 ±0.3 weeks , CI:1.72 to 1.45 ) , CCS Class ( 1.3 ±0.5 vs 3.1 ±0.8 , p < 0.001 ) vs patients with OMT alone CCS Class ( 3.2 ± 0.4 vs 3.3 ± 0.5 , p =0.21 ) . Reversion of angina was sustained through the next 6-months ( 87 % vs 26 % in OMT , RR 2.1 , odds ratio 6.31 , Pearson x2 34.6 , p < 0.0001 at 95 % CI ) and 1-year ( 85 % vs 37 % OMT ) . At 6-months of amiloride , ECG became normal ( 29 % vs 0 % , RR ∞ uncalculated-time , odds ratio ∞ , Pearson x2 42.4 at 95 % CI , p < 0.0001 ) , improved ( 55 % vs 29 % ; RR2.1 , odds ratio 3.16 , 95 % CI , p < 0.0001 ) or unchanged ( 15 % vs 67 % OMT ) . At 1-year , seven patients on amiloride ( 18 % ) exhibited evidence of electrical regeneration of the heart , not observed with placebo . IN CONCLUSION This therapeutical innovation of amiloride improves RBC H/K and O2/CO2 function , and reverses angina , ST-T alterations while inducing electrical regeneration of the heart , in patients receiving optimal medical treatment for angina . The article has short discussion on the relevant patents to the topic .

amiloride

Amiloride

Optimal Medical Therapy

OMT alone

coronary heart diseases .

angina

ST-T alteration


A home-based exercise program to improve function , fatigue , and sleep quality in patients with Stage IV lung and colorectal cancer : a randomized controlled trial . CONTEXT Exercise benefits patients with cancer , but studies of home-based approaches , particularly among those with Stage IV disease , remain small and exploratory . OBJECTIVES To conduct an adequately powered trial of a home-based exercise intervention that can be facilely integrated into established delivery and reimbursement structures . METHODS Sixty-six adults with Stage IV lung or colorectal cancer were randomized , in an eight-week trial , to usual care or incremental walking and home-based strength training . The exercising participants were instructed during a single physiotherapy visit and subsequently exercised four days or more per week ; training and step-count goals were advanced during bimonthly telephone calls . The primary outcome measure was mobility assessed with the Ambulatory Post Acute Care Basic Mobility Short Form . Secondary outcomes included ratings of pain and sleep quality as well as the ability to perform daily activities ( Ambulatory Post Acute Care Daily Activities Short Form ) , quality of life ( Functional Assessment of Cancer Therapy-General ) , and fatigue ( Functional Assessment of Cancer Therapy-Fatigue ) . RESULTS Three participants dropped out and seven died ( five in the intervention and two in the control group , P=0.28 ) . At Week 8 , the intervention group reported improved mobility ( P=0.01 ) , fatigue ( P=0.02 ) , and sleep quality ( P=0.05 ) compared with the usual care group , but did not differ on the other measures . CONCLUSION A home-based exercise program seems capable of improving the mobility , fatigue , and sleep quality of patients with Stage IV lung and colorectal cancer .

home-based exercise program

home-based exercise intervention

physiotherapy

function , fatigue , and sleep quality

mobility


Sensitivity to musical structure in the human brain . Evidence from brain-damaged patients suggests that regions in the temporal lobes , distinct from those engaged in lower-level auditory analysis , process the pitch and rhythmic structure in music . In contrast , neuroimaging studies targeting the representation of music structure have primarily implicated regions in the inferior frontal cortices . Combining individual-subject fMRI analyses with a scrambling method that manipulated musical structure , we provide evidence of brain regions sensitive to musical structure bilaterally in the temporal lobes , thus reconciling the neuroimaging and patient findings . We further show that these regions are sensitive to the scrambling of both pitch and rhythmic structure but are insensitive to high-level linguistic structure . Our results suggest the existence of brain regions with representations of musical structure that are distinct from high-level linguistic representations and lower-level acoustic representations . These regions provide targets for future research investigating possible neural specialization for music or its associated mental processes .

individual-subject fMRI analyses

high-level linguistic structure

representations of musical structure

brain-damaged


Effects of saxagliptin added to sub-maximal doses of metformin compared with uptitration of metformin in type 2 diabetes : the PROMPT study . OBJECTIVE The PROMPT study compared efficacy and tolerability of two treatment intensification strategies : adding saxagliptin or uptitrating metformin monotherapy , in patients with type 2 diabetes ( T2D ) and inadequate glycaemic control on a sub-maximal metformin dose . RESEARCH DESIGN AND METHODS In this double-blind , 24-week study , metformin-tolerant patients with T2D on metformin monotherapy were randomised to receive fixed-dose metformin 1500 mg/day , plus either add-on saxagliptin 5 mg/day ( SAXA-MET ) or a two-step metformin uptitration ( MET-UP ) to a maximum dose ( 2500 mg/day ) . CLINICAL TRIAL REGISTRATION NCT01006590 . MAIN OUTCOME MEASURES Primary : absolute change from baseline in glycated haemoglobin A ( 1c ) ( HbA ( 1c ) ) ( Week 24 ) . Secondary : proportion of patients achieving a therapeutic glycaemic response ( Week 24 ) ; change from baseline in fasting plasma glucose ( Week 24 ) ; safety and tolerability . Exploratory analyses comprised three patient-related questionnaires , including the validated 5-dimension Digestive Health Status Index ( DHSI ) . RESULTS A total of 286 patients were randomised : ( SAXA-MET : 147 ; MET-UP : 139 ) . Baseline mean ( SD ) HbA ( 1c ) : 7.71 ( 0.85 ; SAXA-MET ) ; 7.80 ( 0.82 ; MET-UP ) . Adjusted mean reductions from baseline in HbA ( 1c ) ( Week 24 ) : -0.47 % ( SAXA-MET ) ; -0.38 % ( MET-UP ) ; mean ( 95 % CI ) difference in treatment effect , -0.10 % ( -0.26 , 0.07 ) ; p = 0.260 . The proportion of patients ( 95 % CI ) achieving a therapeutic glycaemic response ( HbA ( 1c ) < 7 % ) : 43.8 % ( 34.8 , 49.6 ) ( SAXA-MET ) vs. 35.0 % ( 29.0 , 43.8 ) ( MET-UP ) . Of the five DHSI domains , mean ( 95 % CI ) differences were observed for diarrhoea-predominant score ( +0.8 [ -2.5 , 4.0 ] vs. +7.9 [ 4.6 , 11.2 ] ) and dysmotility score ( -0.5 [ -2.0 , 1.0 ] vs. +1.9 [ 0.3 , 3.4 ] ) , ( SAXA-MET and MET-UP , respectively ) . The most common adverse event was diarrhoea : 6.1 % ( SAXA-MET ) vs. 12.2 % ( MET-UP ) . CONCLUSIONS In metformin-tolerant patients with T2D ( inadequately controlled on sub-maximal metformin monotherapy ) , saxagliptin was well tolerated . Although HbA ( 1c ) reduction was not significantly different between treatment groups , the lower occurrence of gastrointestinal symptoms in the SAXA-MET group suggests that saxagliptin add-on treatment may be a suitable alternative treatment strategy to metformin uptitration .

saxagliptin

metformin

metformin

saxagliptin

metformin monotherapy

metformin

fixed-dose metformin

therapeutic glycaemic response

fasting plasma glucose ( Week 24 )

safety and tolerability

Baseline mean ( SD ) HbA ( 1c )

baseline in HbA ( 1c )

therapeutic glycaemic response

diarrhoea-predominant


Effects of a brief Early Start Denver model ( ESDM ) -based parent intervention on toddlers at risk for autism spectrum disorders : a randomized controlled trial . OBJECTIVE This study was carried out to examine the efficacy of a 12-week , low-intensity ( 1-hour/wk of therapist contact ) , parent-delivered intervention for toddlers at risk for autism spectrum disorders ( ASD ) aged 14 to 24 months and their families . METHOD A randomized controlled trial involving 98 children and families was carried out in three different sites investigating the efficacy of a parent delivery of the Early Start Denver model ( P-ESDM ) , which fosters parental use of a child-centered responsive interaction style that embeds many teaching opportunities into play , compared to community treatment as usual . Assessments were completed at baseline and 12 weeks later , immediately after the end of parent coaching sessions . RESULTS There was no effect of group assignment on parent-child interaction characteristics or on any child outcomes . Both groups of parents improved interaction skills , and both groups of children demonstrated progress . Parents receiving P-ESDM demonstrated significantly stronger working alliances with their therapists than did the community group . Children in the community group received significantly more intervention hours than those in the P-ESDM group . For the group as a whole , both younger child age at the start of intervention and a greater number of intervention hours were positively related to the degree of improvement in children 's behavior for most variables . CONCLUSIONS Parent-implemented intervention studies for early ASD thus far have not demonstrated the large effects seen in intensive-treatment studies . Evidence that both younger age and more intervention hours positively affect developmental rates has implications for clinical practice , service delivery , and public policy .

Early Start Denver model ( P-ESDM )

efficacy

no effect

interaction skills

demonstrated

progress

stronger

working alliances

intervention hours

number of intervention hours

toddlers

autism spectrum disorders

autism spectrum disorders

ASD

14 to 24 months


Insular and anterior cingulate circuits in smokers with schizophrenia . Schizophrenia ( SZ ) is associated with high rates of smoking . We previously found that resting state functional connectivity ( rsFC ) between the dorsal anterior cingulate ( dACC ) and striatum is independently associated with nicotine addiction and psychiatric illness . Since the insula is implicated in nicotine dependence , we hypothesized that SZ smokers will have greater dysfunction in smoking-related insular and dACC circuits than normal control smokers ( NC ) independent of smoking severity , consistent with an inherent disease-related weakening of smoking-related circuits . Nicotine challenge was used to demonstrate that decreased rsFC in identified circuits reflects addiction trait and is not affected by pharmacological state . Twenty-four NC smokers and 20 smokers with SZ matched on nicotine addiction severity participated in a resting state fMRI study and were scanned during two separate sessions while receiving a placebo or nicotine patch , in a randomized , cross-over design . Using individualized , anatomically defined anterior and posterior insula and dACC as regions of interest ( ROI ) , whole brain rsFC was performed using each ROI as a seed . Significant negative correlations between smoking severity and rsFC between insula , dACC and striatum were found for both groups . Furthermore , smokers with SZ demonstrated additive reductions in circuit strength between the dACC and insula compared to NC smokers independent of smoking severity . Nicotine challenge did not significantly alter rsFC in insula-dACC-striatal circuits . Reduced rsFC strength between the insula , dACC and striatum is associated with nicotine addiction severity in both non-psychiatrically ill and in SZ smokers . Decreased insula-dACC rsFC may index overlapping circuitry associated with smoking and SZ .

placebo

or

nicotine patch ,

in a randomized , cross-over design

smoking severity

rsFC between insula

Nicotine challenge

rsFC strength

schizophrenia

Schizophrenia

SZ

normal control smokers

Twenty-four

NC

SZ

SZ


Multiple courses of rituximab produce sustained clinical and radiographic efficacy and safety in patients with rheumatoid arthritis and an inadequate response to 1 or more tumor necrosis factor inhibitors : 5-year data from the REFLEX study . OBJECTIVE This 5-year observational posthoc analysis of the REFLEX study and its open-label extension assessed clinical efficacy , radiographic response , and safety of rituximab ( RTX ) in patients with rheumatoid arthritis ( RA ) who had an inadequate response to tumor necrosis factor ( TNF ) inhibitors . METHODS Patients in REFLEX were originally randomized to placebo ( PBO ) + methotrexate ( MTX ; PBO-randomized ) or RTX + MTX ( RTX-randomized ) . PBO-randomized patients were rescued with RTX as appropriate . Patients responding to initial RTX treatment could receive further RTX courses . For clinical efficacy and safety analyses , PBO-randomized patients were re-baselined prior to first RTX treatment and the data were pooled with RTX-randomized patient data . Efficacy outcomes 24 weeks after each course were calculated relative to first RTX pretreatment baseline . Radiographic outcomes were assessed relative to randomization baseline for both PBO-randomized and RTX-randomized groups . RESULTS A total of 480 patients received ≥ 1 RTX course . At 24 weeks , American College of Rheumatology 20/50/70 responses were 62.0 % , 30.8 % , and 13.0 % , respectively at course 1 ( n = 400 ) and 70.3 % , 41.8 % , and 22.0 % at course 5 ( n = 91 ) . European League Against Rheumatism good/moderate responses were 77.2 % and 84.4 % at courses 1 ( n = 390 ) and 5 ( n = 90 ) . Rates of adverse events ( AE ) , serious AE , and infections generally remained stable . Rate of progressive joint damage ( PJD ; change in mean Total Sharp Score ) decreased over time in both PBO-randomized ( n = 79 ) and RTX-randomized ( n = 105 ) groups . Mean change from baseline in PJD over 5 years was greater in PBO-randomized versus RTX-randomized patients ( 5.51 vs 3.21 ) . CONCLUSION RTX re-treatment over 5 years is associated with maintained or improved efficacy , continued inhibition of PJD , and a safety profile consistent with that previously reported . A delay in initiating RTX treatment may result in increased PJD .

rituximab

tumor necrosis factor inhibitors

rituximab ( RTX )

placebo

RTX

RTX

RTX

RTX-randomized

RTX

RTX-randomized

adverse events ( AE )

serious AE

infections

progressive joint damage

PJD

rheumatoid arthritis ( RA )


Implementing a simplified neonatal resuscitation protocol-helping babies breathe at birth ( HBB ) - at a tertiary level hospital in Nepal for an increased perinatal survival . BACKGROUND Reducing neonatal death has been an emerging challenge in low and middle income countries in the past decade . The development of the low cost interventions and their effective delivery are needed to reduce deaths from birth asphyxia . This study will assess the impact of a simplified neonatal resuscitation protocol provided by Helping Babies Breathe ( HBB ) at a tertiary hospital in Nepal . Perinatal outcomes and performance of skilled birth attendants on management of intrapartum-related neonatal hypoxia will be the main measurements . METHODS/DESIGN The study will be carried out at a tertiary level maternity hospital in Nepal . A prospective cohort-study will include a six-month baseline a six month intervention period and a three-month post intervention period . A quality improvement process cycle will introduce the neonatal resuscitation protocol . A surveillance system , including CCD cameras and pulse oximeters , will be set up to evaluate the intervention . DISCUSSION Along with a technique to improve health workers performance on the protocol , the study will generate evidence on the research gap on the effectiveness of the simplified neonatal resuscitation protocol on intrapartum outcome and early neonatal survival . This will generate a global interest and inform policymaking in relation to delivery care in all income settings . TRIAL REGISTRATION ISRCTN97846009 .

CCD cameras

pulse oximeters

perinatal survival .

neonatal death

deaths

health workers performance


Association of severity of coexisting patellofemoral disease with increased impairments and functional limitations in patients with knee osteoarthritis . OBJECTIVE To evaluate the association between severity of coexisting patellofemoral ( PF ) disease with lower extremity impairments and functional limitations in patients with tibiofemoral ( TF ) osteoarthritis ( OA ) . METHODS Radiographic views of the TF and PF compartments , knee extension strength , and knee range of motion were obtained for 167 patients with knee OA . Additionally , knee-specific symptoms and functional limitations were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) and the Activities of Daily Living Scale ( ADLS ) . RESULTS Moderate/severe PFOA was associated with lower knee extension strength ( mean ± SD 1.4 ± 0.5 Nm/body weight [ BW ] ) compared to no PFOA ( mean ± SD 1.8 ± 0.5 Nm/BW ) . Additionally , total knee range of motion was significantly lower for patients with moderate/severe PFOA ( mean ± SD 120.8° ± 14.4° ) compared to no PFOA ( mean ± SD 133.5° ± 10.7° ) and mild PFOA ( mean ± SD 125.8° ± 13.0° ) . Moderate/severe PFOA and mild PFOA were also associated with less pain while standing ( odds ratio [ OR ] 0.2 , 95 % confidence interval [ 95 % CI ] 0.1-0.7 and OR 0.2 , 95 % CI 0.1-0.6 , respectively ) on the WOMAC , and moderate/severe PFOA was associated with greater difficulty with going downstairs ( OR 2.9 , 95 % CI 1.0-8.1 ) on the ADLS . CONCLUSION It appears that knees with more severe coexisting PF disease demonstrate features distinct from those observed in TFOA in isolation or in combination with mild PF disease . Treatment strategies targeting the PF joint may be warranted to mitigate the specific lower extremity impairments and functional problems present in this patient population .

Radiographic views

knee extension strength

knee range of motion

knee-specific symptoms

functional limitations

and the

knee extension strength


Patient navigation improves cancer diagnostic resolution : an individually randomized clinical trial in an underserved population . BACKGROUND Barriers to timely resolution of abnormal cancer screening tests add to cancer health disparities among low-income , uninsured , and minority populations . We conducted a randomized trial to evaluate the impact of lay patient navigators on time to resolution and completion of follow-up testing among patients with abnormal screening tests in a medically underserved patient population . METHODS Denver Health , the safety-net health care system serving Denver , is one of 10 performance sites participating in the Patient Navigation Research Program . Of 993 eligible subjects with abnormal screening tests randomized to navigation and no-navigation ( control ) arms and analyzed , 628 had abnormal breast screens ( 66 abnormal clinical breast examinations , 304 BIRADS 0 , 200 BIRADS 3 , 58 BIRADS 4 or 5 ) whereas 235 had abnormal colorectal and 130 had abnormal prostate screens . RESULTS Time to resolution was significantly shorter in the navigated group ( stratified log rank test , P < 0.001 ) . Patient navigation improved diagnostic resolution for patients presenting with mammographic BIRADS 3 ( P = 0.0003 ) and BIRADS 0 ( P = 0.09 ) , but not BIRADS 4/5 or abnormal breast examinations . Navigation shortened the time for both colorectal ( P = 0.0017 ) and prostate screening resolution ( P = 0.06 ) . Participant demographics included 72 % minority , 49 % with annual household income less than $ 10,000 , and 36 % uninsured . CONCLUSIONS Patient navigation positively impacts time to resolution of abnormal screening tests for breast , colorectal , and prostate cancers in a medically underserved population . IMPACT By shortening the time to and increasing the proportion of patients with diagnostic resolution patient navigation could reduce disparities in stage at diagnosis and improve cancer outcomes .

Patient navigation

lay patient navigators

navigation

no-navigation ( control )

Patient navigation

Patient navigation

Time to resolution

diagnostic resolution

colorectal

prostate screening resolution

resolution

underserved population .


Dalteparin low molecular weight heparin ( LMWH ) in ovarian cancer : a phase II randomized study . OBJECTIVE Low molecular weight heparin reduces the risk of venous thromboembolism ( VTE ) and may have antineoplastic effects by interfering with angiogenesis and with tumor growth and metastasis . A multicentre phase II randomized trial was done to evaluate the antineoplastic potential of dalteparin in ovarian cancer ( OC ) . MATERIALS AND METHODS Women with newly-diagnosed epithelial OC were randomized to receive standard chemotherapy ( CT ) and one of 3 doses of dalteparin ( 50 IU/kg , 100 IU/kg , or 150 IU/kg ) subcutaneously once daily during the first 3 of 6 cycles of 3-weekly CT . Blood was drawn on day 1 of each cycle for CA125 and , in a substudy of randomized patients , for markers of coagulation activation and angiogenesis . The primary outcome was tumor response defined by ≥ 50 % reduction in serum CA125 from baseline sustained for at least 28 days . Patients were followed until the end of CT . RESULTS The study was terminated early due to poor recruitment . Seventy-seven women were evaluable for the primary outcome . A 50 % drop in CA125 at the end of cycle 3 was seen in 85 % of the 50 IU/kg group , 92 % of the 100 IU/kg group , and 85 % of the 150 IU/kg group . There were no symptomatic VTE or major bleeding events while on dalteparin . Two patients experienced VTE several days after discontinuing study drug . Women on dalteparin had lower levels of D-dimer and thrombin-antithrombin , and higher levels of tissue factor pathway inhibitor , relative to baseline . CONCLUSION Dalteparin is safe and well tolerated in women receiving CT for newly-diagnosed epithelial OC . A dose-response effect was not identified . The lack of control group precluded any inference on the antineoplastic effect of dalteparin .

Dalteparin

heparin

dalteparin

standard chemotherapy ( CT )

dalteparin

VTE

D-dimer and thrombin-antithrombin

ovarian cancer

Women

newly-diagnosed epithelial OC

Seventy-seven

women


Computer-navigated versus conventional total knee arthroplasty a prospective randomized trial . BACKGROUND The literature lacks studies that confirm whether the improved radiographic alignment that can be achieved with computer-navigated total knee arthroplasty improves patients ’ activities of daily living or the durability of total knee prostheses . The purpose of this study was to determine whether computer-navigated total knee arthroplasty improves the clinical function , alignment , and survivorship of the components . METHODS We prospectively compared the results of 520 patients with osteoarthritis who underwent computer-navigated total knee arthroplasty for one knee and conventional total knee arthroplasty for the other . The assignment of the knee to navigation or not was done randomly . There were 452 women ( 904 knees ) and sixty-eight men ( 136 knees ) with a mean age of sixty-eight years ( range , forty-nine to eighty-eight years ) at the time of the index arthroplasty . The mean follow-up period was 10.8 years ( range , ten to twelve years ) . The patients were assessed clinically and radiographically with the rating system of the Knee Society and with the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) score at three months , one year , and annually thereafter . RESULTS Total knee scores , knee function scores , pain scores , WOMAC scores , knee motion , and activity scores did not show statistically significant differences between the two groups preoperatively or at the time of the final follow-up . Alignment and the survivorship of the components were not significantly different between the two groups . The Kaplan-Meier survivorship with revision as the end point at 10.8 years was 98.8 % ( 95 % confidence interval [ CI ] , 0.96 to 1.00 ) in the computernavigated total knee arthroplasty group and 99.2 % ( 95 % CI , 0.96 to 1.00 ) in the conventional total knee arthroplasty group . CONCLUSIONS Our data demonstrated no difference in clinical function or alignment and survivorship of the components between the knees that underwent computer-navigated total knee arthroplasty and those that underwent conventional total knee arthroplasty .

Computer-navigated

conventional total knee arthroplasty

rating system of the Knee Society

Total knee scores

knee function scores

pain scores

WOMAC scores

knee motion

activity scores

The Kaplan-Meier survivorship

osteoarthritis

women ( 904 knees

sixty-eight

men ( 136 knees

mean age of sixty-eight years


The effect of prethrombolytic cyclosporine-A injection on clinical outcome of acute anterior ST-elevation myocardial infarction . INTRODUCTION Reperfusion injury reduces the benefits of early reperfusion therapies after acute ST-elevation myocardial infarction ( STEMI ) . Cyclosporine-A ( CsA ) is a potent inhibitor of opening of the mitochondrial permeability transition pore , which has been shown to play a key role in myocardial reperfusion injury . The impact of this treatment on clinical outcomes of acute STEMI remains unknown . Our aim was to investigate the clinical outcomes of using this drug in patients with acute anterior STEMI receiving thrombolytic treatment ( TLT ) . METHODS In this double-blinded randomized clinical trial , 101 patients with acute anterior STEMI who were candidate for TLT , were enrolled and randomly assigned into treatment or control groups . Patients in the treatment group received an intravenous bolus injection of 2.5 mg/kg of CsA immediately before TLT . The patients in the control group received an equivalent volume of normal saline . Infarct size , occurrence of major arrhythmias , heart failure , left ventricular ejection fraction ( LVEF ) , TLT-related complications , in-hospital and 6-month mortality rates were investigated . RESULTS There were no significant differences among the demographics , myocardial enzyme release , occurrence of major arrhythmias [ 9 ( 18 % ) vs. 12 ( 23.5 % ) , P = 0.80 ] , heart failure [ 18 ( 36 % ) vs. 19 ( 38.3 % ) , P = 0.83 ] , LVEF at first day [ 34.7 ± 9.9 % vs. 33.5 ± 8.1 % , P = 0.50 ] or at discharge [ 37.7 ± 10 % vs. 36.1 ± 8.2 % , P = 0.43 ] , and in-hospital [ 4 ( 8 % ) vs. 6 ( 11.8 % ) , P = 0.74 ] or 6-month mortality rates [ 9 ( 18 % ) vs. 10 ( 19.6 % ) , P = 0.99 ] between the CsA vs. the control group . CONCLUSION In this study , the prethrombolytic administration of CsA was not associated with a reduction in the infarct size or any improvement in clinical outcomes .

Cyclosporine-A ( CsA )

CsA

normal saline

TLT-related complications

in-hospital and 6-month mortality rates

heart failure

LVEF at first day

6-month mortality rates


A pilot study on the efficacy of melodic based communication therapy for eliciting speech in nonverbal children with autism . The purpose of this study was to compare the efficacy of melodic based communication therapy ( MBCT ) to traditional speech and language therapy for eliciting speech in nonverbal children with autism . Participants were 12 nonverbal children with autism ages 5 through 7 randomly assigned to either treatment group . Both groups made significant progress after treatment . The MBCT group progressed significantly in number of verbal attempts after weeks 1 through 4 and number of correct words after weeks 1 and 3 , while the traditional group progressed significantly after weeks 4 and 5 . No significant differences in number of verbal attempts or number of correct words were noted between groups following treatment . A significant number of new words were heard in the home environment for the MBCT group ( p = .04 ) . Participants in the MBCT group had more imitative attempts ( p = .03 ) . MBCT appears to be a valid form of intervention for children with autism .

melodic based communication therapy

traditional speech and language therapy

MBCT

MBCT

eliciting speech

eliciting speech

progress

number of verbal attempts

number of correct words

number of verbal attempts

number of correct words

number of new words

imitative attempts

nonverbal

children

autism

nonverbal children

autism

ages 5 through 7


Potential effect of the risk of ovarian cancer algorithm ( ROCA ) on the mortality outcome of the Prostate , Lung , Colorectal and Ovarian ( PLCO ) trial . Recently , the Prostate , Lung , Colorectal and Ovarian ( PLCO ) Trial reported no mortality benefit for annual screening with CA-125 and transvaginal ultrasound ( TVU ) . Currently ongoing is the UK Collaborative Trial of Ovarian Cancer Screening ( UKCTOCS ) , which utilizes the risk of ovarian cancer algorithm ( ROCA ) , a statistical tool that considers current and past CA125 values to determine ovarian cancer risk . In contrast , PLCO used a single cutoff for CA125 , based on current levels alone . We investigated whether having had used ROCA in PLCO could have , under optimal assumptions , resulted in a significant mortality benefit by applying ROCA to PLCO CA125 screening values . A best-case scenario assumed that all cancers showing a positive screen result earlier with ROCA than under the PLCO protocol would have avoided mortality ; under a stage-shift scenario , such women were assigned survival equivalent to Stage I/II screen-detected cases . Updated PLCO data show 132 intervention arm ovarian cancer deaths versus 119 in usual care ( relative risk , RR = 1.11 ) . Forty-three ovarian cancer cases , 25 fatal , would have been detected earlier with ROCA , with a median ( minimum ) advance time for fatal cases of 344 ( 147 ) days . Best-case and stage-shift scenarios gave 25 and 19 deaths prevented with ROCA , for RRs of 0.90 ( 95 % CI : 0.69-1.17 ) and 0.95 ( 95 % CI : 0.74-1.23 ) , respectively . Having utilized ROCA in PLCO would not have led to a significant mortality benefit of screening . However , ROCA could still show a significant effect in other screening trials , including UKCTOCS .

ovarian cancer algorithm ( ROCA )

ovarian cancer algorithm ( ROCA )

ROCA in PLCO

ROCA

ROCA

ROCA

ROCA

mortality outcome

significant mortality benefit

mortality

fatal cases

deaths

mortality benefit


Effects of psychosocial program for preparing long-term hospitalized patients with schizophrenia for discharge from hospital : randomized controlled trial . AIM The aims of the present study were to revise the Community Re-entry Program-Japanese version and to review the effectiveness of the revised Program , named the Discharge Preparation Program . METHODS This study was a randomized controlled trial . The Discharge Preparation Program ( DPP ) was the intervention condition ( n = 26 ) , and the usual rehabilitation program was the control condition ( n = 23 ) . Outcome indicators included factors that make patient discharge difficult ( which nurses evaluated ) , psychiatric symptom , knowledge about the illness or medication , and the number of patients who were discharged within 6 months after the end of a program . RESULTS Significant improvements were found in the score of the 'Issues on treatment compliance ' factor and the score of the 'Autistic life ' factor , which are subscales of the Discharge Difficulty Scale , for the DPP group , on two-way ANOVA ( 'Issues on treatment compliance ' : F = 3.818 , P < 0.10 ; 'Autistic life ' : F = 4.155 , P < 0.05 ) These factors affected discharge outcome . Thus , the program may be capable of promoting discharge of long-term hospitalized psychiatric patients . With regard to the number of patients discharged in 6 months after the end of a program , there was no significant difference between both groups . CONCLUSION The present result is in agreement with past studies , and the DPP is useful in discharge support for patients with schizophrenia in Japan .

psychosocial program

Discharge Preparation Program

Discharge Preparation Program ( DPP )

usual rehabilitation program

DPP

DPP

effectiveness

psychiatric symptom

knowledge about the illness

Discharge Difficulty Scale

discharge outcome

long-term hospitalized patients

schizophrenia

schizophrenia

Japan


Effects of conjugated linoleic acid supplementation and exercise on post-heparin lipoprotein lipase , butyrylcholinesterase , blood lipid profile and glucose metabolism in young men . This study was designed to investigate the effects of conjugated linoleic acid ( CLA ) supplementation and endurance exercise training-induced changes on post-heparin lipoprotein lipase ( PH-LPL ) and butyrylcholinesterase ( BChE ) activities along with leptin , insulin and lipid levels in plasma by a randomized double blind experiment . Eighteen sedentary male volunteers were randomly divided into CLA and Placebo ( PLC ) supplementation groups . Both groups underwent daily supplementation of either 3g CLA or 3g placebo for 30 days , respectively , and performed exercise on a bicycle ergometer 3 times per week for 30-40 min at 50 % VO2 peak workload . For plasma glucose , insulin and leptin levels and BChE activity fasting blood was used . For PH-LPL measurements , blood was collected 15 min after 50 IU/kg iv heparin injection . In all groups , there is a statistically significant decrease in BChE ( p = 0.03 , p = 0.02 ) and leptin ( p = 0.002 ) , insulin and HOMA-IR levels ( p = 0.02 ) . Exercise with or without CLA supplementation decreased insulin levels and increased insulin sensitivity . PH-LPL activity was increased significantly in both groups , displaying increased fatty acid mobilization . We conclude that though CLA supplementation and exercise can affect these parameters , CLA is not more effective than exercise alone . Hence , a prolonged supplementation regime may be more effective . Taken together in our small study group , our findings display that BChE is a potential marker for synthetic function of liver , fat metabolism , an obesity marker , a function long overlooked .

exercise

endurance exercise

randomly

CLA

Placebo ( PLC )

CLA

placebo

CLA

CLA

CLA

PH-LPL measurements

BChE

leptin

insulin

HOMA-IR levels

insulin levels

insulin sensitivity

PH-LPL activity

BChE

young

men

Eighteen

male


The effects of moderate to vigorous aerobic exercise on the sleep need of sedentary young adults . Exercise has been recommended for enhancing sleep ; a claim linked to the belief that sleep need - defined by sleep duration and depth - is increased post-exercise to allow tissue recovery . Objective studies investigating exercise-sleep responses have produced mixed outcomes , and the disparity in results between studies may be due to differences in individual characteristics and/or exercise protocol , emphasising the importance of carefully controlled trials . We investigated the role of exercise on the sleep need of sedentary adults , after controlling for exercise mode , timing and duration . Twelve healthy volunteers ( 25.2 ± 4.0 years , 9 females , [ Vdot ] O ( 2 ) max 35.4 ± 8.8 ml· kg ( -1 ) · min ( -1 ) ) were randomised to no-exercise or to a bout of treadmill exercise at 45 % , 55 % , 65 % or 75 % [ Vdot ] O ( 2 ) max in a crossover design . Sleep on no-exercise and exercise nights were assessed by polysomnography . Participants spent a greater proportion of sleep in light sleep ( stage 1 + stage 2 ) after exercise at both 65 % and 75 % [ Vdot ] O ( 2 ) max ( P < 0.05 ) than the no-exercise condition . There was a trend of a reduced proportion of rapid eye movement sleep with increased exercise intensity ( P = 0.067 ) . No other changes were observed in any other sleep variables . Two findings emerged : vigorous exercise did not increase sleep need ; however , this level of exercise increased light sleep .

moderate to vigorous aerobic exercise

Exercise

exercise

exercise

sleep need of sedentary young adults .

sedentary adults


Effects of nitric oxide synthase inhibition on cutaneous vasodilation in response to acupuncture stimulation in humans . OBJECTIVES The aim of the present study was to elucidate the mechanism of cutaneous vasodilation following acupuncture stimulation by investigating the roles of nitric oxide ( NO ) and axon reflex vasodilation . METHODS The subjects were 17 healthy male volunteers . The role of NO was investigated by administering N ( G ) -nitro-l-arginine methyl ester hydrochloride ( L-NAME , 20 mM ) , an NO synthase inhibitor or Ringer 's solution ( control site ) , via intradermal microdialysis ( protocol 1 ; n=7 ) . The role of axon reflex vasodilation by local sensory neurones was investigated by comparing vasodilation at sites treated with 'eutectic mixture of local anaesthetics ' ( EMLA ) cream ( 2.5 % lidocaine and 2.5 % prilocaine ) with untreated sites ( control site ) ( protocol 2 ; n=10 ) . After 5 min of baseline recording , acupuncture was applied to PC4 and a control site in proximity to PC4 for 10 min and scanning was performed for 60 min after acupuncture stimulation . Skin blood flow ( SkBF ) was evaluated by laser Doppler perfusion imaging . Cutaneous vascular conductance ( CVC ) was calculated from the ratio of SkBF to mean arterial blood pressure . RESULTS In the first protocol , sites administered L-NAME showed significant reductions in CVC responses following acupuncture stimulation compared to control sites ( administered Ringer 's solution ) ( p < 0.05 ) . In the second protocol , changes in CVC responses after acupuncture stimulation did not differ significantly between treated sites with EMLA cream and untreated sites ( p > 0.05 ) . CONCLUSIONS These data suggest that cutaneous vasodilation in response to acupuncture stimulation may not occur through an axon reflex as previously reported . Rather , NO mechanisms appear to contribute to the vasodilator response .

nitric oxide synthase inhibition

acupuncture

NO synthase inhibitor

Ringer 's solution

lidocaine

prilocaine

acupuncture

Ringer 's

EMLA

cutaneous vasodilation

Skin blood flow ( SkBF )

Doppler perfusion imaging

Cutaneous vascular conductance ( CVC )

CVC responses

changes in CVC responses

healthy

male volunteers


The effects of a six-week supervised multimodal exercise intervention during chemotherapy on cancer-related fatigue . PURPOSE Cancer related fatigue ( CRF ) is a common problem for cancer patients across diagnoses during chemotherapy and is associated with physical inactivity , lower functional level and lack of energy . Few RCT exercise intervention studies have included cancer patients undergoing chemotherapy . The objective of this study is to evaluate whether a six-week supervised multimodal exercise intervention , adjunct to chemotherapy and standard care , can reduce the patient 's CRF level . METHODS Data is based on analyses of a prospective randomised controlled trial 'The Body & Cancer Trial ' . 213 cancer patients with different diagnoses were randomised into an intervention group or wait-list control group . The primary outcome , Fatigue score ( CRF ) , was evaluated by the Functional Assessment of Cancer Therapy-Anaemia Questionnaire ( FACT-An- ) ( FACT-G score & FACT-An Anemia subscale ) . INTERVENTION Supervised exercise , comprising high-intensity cardiovascular and heavy resistance training , relaxation- and body awareness training and massage , 9 h weekly for 6 weeks . RESULTS CRF was significantly reduced in the intervention group , corresponding to a Fatigue score reduction of 3.04 ( effect size of 0.44 , 95 % CI 0.17-0.72 ) ( P = .002 ) , the FACT-An score by 5.40 ( P = .015 ) , the FACT-An Toi score by 5.22 ( P = .009 ) and the Anaemia-ANS by 3.76 ( P = .002 ) . There was no statistically significant effect on the General Quality of Life score ( FACT-G ) or on any of the individual wellbeing scores ; Physical ( P = .13 ) , Emotional ( P = .87 ) , Social ( P = .83 ) and Functional ( P = .26 ) . CONCLUSION In summary , this six-week supervised multimodal exercise intervention can lead to significant reduction in self-reported CRF in cancer patients undergoing chemotherapy .

multimodal exercise intervention

chemotherapy

chemotherapy

exercise intervention

intervention group

wait-list control group

cancer-related fatigue

Cancer related fatigue ( CRF )

CRF level

Fatigue score ( CRF )

CRF

Fatigue score reduction

FACT-An score

FACT-An Toi

Anaemia-ANS

General Quality of Life score

individual wellbeing scores ; Physical

Emotional

Social

Functional

self-reported CRF

cancer-related fatigue .

into


Hemostasis by bipolar coagulation versus suture after surgical stripping of bilateral ovarian endometriomas : a randomized controlled trial . STUDY OBJECTIVE To estimate whether the suture of the ovary is superior to bipolar coagulation in preserving ovarian reserve in infertile women undergoing laparoscopic stripping of bilateral endometriomas . DESIGN Randomized controlled trial ( Canadian Task Force classification I ) . SETTING University teaching hospital . PATIENTS 100 patients with bilateral endometriomas . INTERVENTIONS Patients underwent stripping of bilateral endometriomas and were randomized to undergo hemostasis by use of either laparoscopic suturing ( LS group ) or bipolar coagulation ( BC group ) . Changes in ovarian reserve were investigated by measuring the levels of anti-Mullerian hormone ( AMH ) and basal follicle-stimulating hormone ( FSH ) before surgery and at 3 , 6 and 12 months from surgery . MEASUREMENTS AND MAIN RESULTS At 3-month , 6-month , and 12-month follow-up , in both study groups , postsurgical AMH levels were significantly lower and basal FSH levels were significantly higher than before surgery . There was no significant difference in the mean percentage decrease of AMH levels in the BC group and LS group at 3- , 6- , and 12-month follow-up . The mean percentage increase in basal FSH was higher in the BC group than in the LS group at both 3-month ( p = .023 ) and 6-month follow-up ( p = .029 ) , but not at 12-month follow-up . Pregnancy rate , time to conception , and rate of endometrioma recurrence was similar in the 2 study groups . CONCLUSION Laparoscopic stripping of ovarian endometriotic cyst significantly decreases serum AMH levels and increases basal FSH levels independent from the method used to obtain hemostasis on the ovarian tissue .

bipolar coagulation

suture

surgical stripping

suture of the ovary

bipolar coagulation

stripping of bilateral endometriomas

laparoscopic suturing ( LS group )

bipolar coagulation ( BC

Changes in ovarian reserve

postsurgical AMH levels

basal FSH levels

AMH levels

basal FSH

serum AMH levels

basal FSH levels

University teaching hospital .