Prophylactic amnioinfusion in pregnancies complicated by oligohydramnios : a prospective study . Prophylactic amnioinfusion was assessed in term and post-dates pregnancies with decreased amniotic fluid volume . Subjects were randomly assigned to one of three groups : amnioinfusion with warmed saline solution , room-temperature saline , or control . Patients receiving prophylactic amnioinfusion had a significant decrease in both the frequency and severity of variable decelerations in the first stage of labor ( P = .006 ) and in the average total number of variable decelerations in the first and second stages of labor ( P = .01 ) compared with controls . There was no observed effect on newborn serum electrolyte levels with amnioinfusion , nor was there any apparent benefit of infusion of warmed saline compared with room-temperature saline . In contrast to premature gestations with oligohydramnios , prophylactic amnioinfusion was not associated with a significant improvement in mean umbilical arterial and venous pH or a significant decrease in cesarean delivery for fetal distress ( P = .09 ) . This is perhaps because the term fetus has an enhanced ability to tolerate recurrent episodes of heart rate decelerations without demonstrating the rapid metabolic changes seen in the premature fetus .

amnioinfusion

amnioinfusion

amnioinfusion

warmed saline solution

room-temperature saline

control

amnioinfusion

amnioinfusion

amnioinfusion

newborn serum electrolyte levels

mean umbilical arterial and venous pH

significant decrease

cesarean delivery for fetal distress

heart rate decelerations


Prospective study of Clostridium difficile intestinal colonization and disease following single-dose antibiotic prophylaxis in surgery . A total of 108 volunteers undergoing an elective surgical procedure were randomly given a single 2-g intravenous prophylactic dose of either a cephalosporin or mezlocillin . Stool samples were cultured for Clostridium difficile the day before the operation and later on postoperative days 4 , 7 , and 14 . C. difficile was detected in 23.0 % of patients who received a cephalosporin ( cefoxitin , 8.3 % ; cefazolin , 14.3 % ; cefotetan , 20.0 % ; ceftriaxone , 25.0 % ; cefoperazone , 43.7 % ) , in 3.3 % of patients given mezlocillin , and in none of 15 control volunteers given no antimicrobial agent . No patient experienced diarrhea .

single-dose antibiotic prophylaxis

mezlocillin

no antimicrobial agent .

Clostridium difficile

C. difficile

diarrhea .

elective surgical procedure


Helping women make choices about mammography screening : an online randomized trial of a decision aid for 40-year-old women . OBJECTIVE To evaluate the effect of a decision aid ( DA ) on women 's knowledge of the benefits and harms of screening and on their ability to make an informed decision . METHODS An online randomized controlled trial among 321 women aged 38-45 years was conducted . Participants were randomized to either immediate or delayed access to the online DA which ( i ) explained the benefits and harms , ( ii ) included a values clarification exercise and a worksheet to support decision making . The primary outcome , knowledge of benefits and harms of screening , and secondary outcomes , informed choice ( composite of knowledge , values and intention ) , anxiety and acceptability of the DA were measured using online questionnaires . RESULTS Women in the intervention group were more knowledgeable ( mean score out of 10 , 7.35 vs 6.27 , p < 0.001 ) and were more likely to have made a decision ( 82 % vs 61 % p < 0.001 ) . Of those who made a decision , women in the intervention group were less likely to start screening now ( 52 % vs 65 % p=0.05 ) . There was no significant difference in the proportion of women who made an informed choice ( 71 % intervention group vs 64 % control group , p=0.24 ) . The DA was helpful , balanced and clear , and did not make women anxious . CONCLUSIONS The DA increased knowledge and reduced indecision , without increasing feelings of anxiety . PRACTICE IMPLICATIONS This decision aid is easy to access online and could be an inexpensive way of supporting women aged 40 who are considering whether to start screening now , or wait until they are 50 . The results of this study demonstrate the potential of DAs to help inform women about both the benefits and risks of screening at this age and to support women and clinicians in this decision making process .

decision aid ( DA )

control

informed choice

composite of knowledge

values and intention

anxiety and acceptability of the DA

knowledgeable

start screening now

anxious

knowledge

indecision

feelings of anxiety

women

women

aged 38-45 years

Women


Optimal dose of lignocaine for preventing pain on injection of propofol . The purpose of this study was to define the optimum dose of lignocaine required to reduce pain on injection of propofol . We conducted a prospective , randomized , double-blind trial on 310 patients undergoing anaesthesia . Patients were allocated to four groups according to the lignocaine dosage : group A ( control ) , no lignocaine ; group B , lignocaine 0.1 mg kg-1 ; group C , lignocaine 0.2 mg kg-1 ; group D , lignocaine 0.4 mg kg-1 . Our results showed that a dose of lignocaine 0.1 mg kg-1 significantly reduced the incidence of pain and that there was no improvement when the dose was increased .

lignocaine

lignocaine

control

lignocaine

lignocaine

lignocaine 0.4 mg kg-1

pain

pain

incidence of pain

310 patients

anaesthesia


Biventricular pacing improves cardiac function and prevents further left atrial remodeling in patients with symptomatic atrial fibrillation after atrioventricular node ablation . BACKGROUND Randomized trials have demonstrated benefits of biventricular ( BiV ) pacing in patients with advanced heart failure , intraventricular conduction delay , and atrial fibrillation ( AF ) post-atrioventricular ( AV ) node ablation . The AV Node Ablation with CLS and CRT Pacing Therapies for Treatment of AF trial ( AVAIL CLS/CRT ) was designed to demonstrate superiority of BiV pacing in patients with AF after AV node ablation , to evaluate its effects on cardiac structure and function , and to investigate additional benefits of Closed Loop Stimulation ( CLS ) ( BIOTRONIK , Berlin , Germany ) . METHODS Patients with refractory AF underwent AV node ablation and were randomized ( 2:2:1 ) to BiV pacing with CLS , BiV pacing with accelerometer , or right ventricular ( RV ) pacing . Echocardiography was performed at baseline and 6 months , with paired data available for 108 patients . RESULTS The RV pacing contributed to significant increase in left atrial volume , left ventricular ( LV ) end-systolic volume , and LV mass compared to BiV pacing . Ejection fraction decreased insignificantly with RV pacing compared to significant increase with BiV pacing . Interventricular dyssynchrony significantly decreased with BiV compared with RV pacing . Closed Loop Stimulation did not result in additional echocardiographic changes ; heart rate distribution was significantly wider with CLS . All groups showed significant improvement in 6-minute walk distance , quality-of-life score , and New York Heart Association class . CONCLUSION In conclusion , RV pacing results in significant increase in left atrial volume , LV mass , and worsening of LV contractility compared to patients receiving BiV pacing post-AV node ablation for refractory AF . Closed Loop Stimulation was not associated with additional structural changes but resulted in significantly wider heart rate distribution .

biventricular ( BiV ) pacing

cardiac function

left atrial remodeling

Ejection fraction

Interventricular dyssynchrony

echocardiographic changes

heart rate distribution

6-minute walk distance

quality-of-life score

New York Heart Association class

left atrial volume

worsening of LV contractility

structural changes

wider heart rate distribution

symptomatic atrial fibrillation

advanced heart failure

intraventricular conduction delay ,

AF


A randomized comparison of the Endeavor zotarolimus-eluting stent versus the TAXUS paclitaxel-eluting stent in de novo native coronary lesions 12-month outcomes from the ENDEAVOR IV trial . OBJECTIVES The ENDEAVOR IV ( Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease ) trial evaluated the safety and efficacy of the zotarolimus-eluting stent ( ZES ) compared with the paclitaxel-eluting stent ( PES ) . BACKGROUND First-generation drug-eluting stents have reduced angiographic and clinical restenosis , but long-term safety remains controversial . A second-generation drug-eluting stent , which delivers zotarolimus , a potent antiproliferative agent , via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut stent has shown promising experimental and early clinical results . METHODS This is a prospective , randomized ( 1:1 ) , single-blind , controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES . The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death , myocardial infarction , or target vessel revascularization . RESULTS Among a total of 1,548 patients assigned to ZES ( n = 773 ) or PES ( n = 775 ) , at 9 months , ZES was noninferior to PES with rates of target vessel failure 6.6 % versus 7.1 % , respectively ( p ( noninferiority ) < or = 0.001 ) . There were fewer periprocedural myocardial infarctions with ZES ( 0.5 % vs. 2.2 % ; p = 0.007 ) , whereas at 12 months , there were no significant differences between groups in rates of cardiac death , myocardial infarction , target vessel revascularization , or stent thrombosis . Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES ( 15.3 % vs. 10.4 % ; p = 0.284 ) , rates of 12-month target lesion revascularization were similar ( 4.5 % vs. 3.2 % ; p = 0.228 ) , especially in patients without planned angiographic follow-up ( 3.6 % vs. 3.2 % ; p = 0.756 ) . CONCLUSIONS These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions . ( ENDEAVOR IV Clinical Trial ; NCT00217269 ) .

Endeavor zotarolimus-eluting stent

TAXUS paclitaxel-eluting stent

Zotarolimus-Eluting

Paclitaxel-Eluting Stents

zotarolimus-eluting stent ( ZES )

paclitaxel-eluting stent ( PES )

zotarolimus

ZES

ZES

ZES

ZES

PES

safety and efficacy

9-month target vessel failure

target vessel failure

periprocedural myocardial infarctions

target lesion revascularization

1,548 patients


Allogeneic marrow transplantation in patients with chronic myeloid leukemia in the chronic phase : a randomized trial of two irradiation regimens . A randomized trial was performed to compare two regimens of total body irradiation in patients with chronic myeloid leukemia treated by allogeneic marrow transplantation while in the chronic phase . All patients received cyclophosphamide 120 mg/kg followed by total body irradiation and marrow from HLA-identical siblings . Cyclosporine and methotrexate were used for prophylaxis against acute graft-versus-host disease . Fifty-seven patients were randomized to receive 2.0 Gy fractions of irradiation daily for 6 days and 59 were randomized to receive 2.25 Gy fractions daily for 7 days . The probabilities of relapse at 4 years were 0.25 for the 12.0 Gy group and 0.00 for the 15.75 Gy group ( P = .008 ) . The actuarial probabilities of survival and relapse-free survival at 4 years were 0.60 and 0.58 among the patients who received 12.0 Gy compared with 0.66 and 0.66 for those who received 15.75 Gy . The 4-year probabilities of transplant-related mortality were 0.24 and 0.34 respectively ( P = .13 ) while the probability of moderate to severe acute graft-versus-host disease was 0.33 for the 12.0 Gy group and 0.44 for the 15.75 Gy group ( P = .15 ) . The lower relapse probability in the patients receiving the higher dose of total body irradiation did not result in improved survival because mortality from causes other than relapse was increased .

Allogeneic marrow transplantation

total body irradiation

allogeneic marrow transplantation

cyclophosphamide

Cyclosporine and methotrexate

irradiation

total body irradiation

probabilities of relapse

relapse probability

survival

Fifty-seven


Pilot randomized controlled trial of Reciprocal Imitation Training for teaching elicited and spontaneous imitation to children with autism . Children with autism exhibit significant deficits in imitation skills . Reciprocal Imitation Training ( RIT ) , a naturalistic imitation intervention , was developed to teach young children with autism to imitate during play . This study used a randomized controlled trial to evaluate the efficacy of RIT on elicited and spontaneous imitation skills in 21 young children with autism . Results found that children in the treatment group made significantly more gains in elicited and spontaneous imitation , replicating previous single-subject design studies . Number of spontaneous play acts at pre-treatment was related to improvements in imitation during the intervention , suggesting that children with a greater play repertoire make greater gains during RIT .

Reciprocal Imitation Training

Reciprocal Imitation Training ( RIT )

spontaneous imitation

imitation skills .

efficacy

imitation skills

significantly more gains

elicited and spontaneous imitation

Number of spontaneous play acts

imitation


Can incentives undermine intrinsic motivation to participate in epidemiologic surveys ? Response rates to surveys are decreasing . The purpose of this study was to evaluate the use of lottery tickets as incentives in an epidemiologic control group . A self-administered questionnaire was sent to parents in the municipality of Stockholm , Sweden , who were to be used as a control group in a study addressing stress in parents of children with cancer . A stratified random sample of 450 parents were randomized into three incentive groups : ( a ) no incentive ; ( b ) a promised incentive of one lottery ticket to be received upon reply ; ( c ) a promised incentive of one lottery ticket to be received upon reply and an additional lottery ticket upon reply within 1 week . The overall response rate across the three groups was 65.3 % . The response rate was highest in the no incentive group ( 69.3 % ) and lowest in the one plus one lottery ticket group ( 62.0 % ) . In a survival analysis , the difference between the two response curves was significant by the log-rank test ( P = 0.04 ) , with the no incentive group having a shorter time to response than the incentive group . Our findings suggest that the use of lottery tickets as incentives to increase participation in a mail questionnaire among parents may be less valuable or even harmful . Incentives may undermine motivation in studies in which the intrinsic motivation of the respondents is already high .

incentives

use of lottery tickets as incentives

no incentive

no incentive group

one plus one lottery ticket group

incentive group

lottery tickets

Incentives

intrinsic motivation

response rate

survival analysis

increase participation

motivation

epidemiologic control group .

children

with cancer .


A randomized , double-blind , placebo-controlled , phase I study of MEDI-545 , an anti-interferon-alfa monoclonal antibody , in subjects with chronic psoriasis . BACKGROUND Interferon-alfa ( IFN-alpha ) has been implicated in the pathogenesis of psoriasis . OBJECTIVE To evaluate the safety profile of MEDI-545 , a fully human anti-IFN-alpha monoclonal antibody and to explore its effect on the involvement of type I IFN-alpha activity in the maintenance of established plaque psoriasis . METHODS We conducted an 18-week , randomized , double-blind , placebo-controlled , dose-escalating study in 36 subjects with chronic plaque psoriasis . Subjects received one intravenous dose of MEDI-545 ( 0.3-30.0 mg/kg ) or placebo . Study outcomes were safety profile , pharmacokinetics , immunogenicity , and clinical effects . RESULTS There was no difference in adverse events between MEDI-545 and placebo . Two serious adverse events were reported ; one drug-related hypotensive infusion reaction occurred in one subject in the 30.0 mg/kg MEDI-545 dose group , causing discontinuation of study drug in that subject and study dismissal of the other subjects in the same cohort ; and a myocardial infarction occurred in one subject in the 10 mg/kg MEDI-545 dose group , which was considered to be unrelated to treatment . MEDI-545 was nonimmunogenic , had a half-life of 21 days , showed no significant inhibition of the type I IFN gene signature , and had no clinical activity . LIMITATIONS The study addressed only IFN-alpha and chronic psoriatic lesions . CONCLUSION The safety profile of MEDI-545 supports further clinical development . IFN-alpha does not appear to be significantly involved in the maintenance of established plaque psoriasis .

placebo-controlled

placebo-controlled

placebo

placebo

safety profile

pharmacokinetics

immunogenicity

clinical effects

adverse events

myocardial infarction

half-life


Relief of periorbital pain after acute angle closure glaucoma attack by botulinum toxin type A . PURPOSE To assess the efficacy and safety of botulinum toxin type A ( BoNT-A ) injection in patients suffering from intractable periorbital pain after acute angle closure glaucoma ( AACG ) . PATIENTS AND METHODS In this prospective randomized intervention study , 19 patients suffering from periorbital pain after an AACG attack were injected with BoNT-A or placebo for pain relief . Patients were assessed on days 1 , 2 , 7 , 14 , 30 , 60 , and 90 . The main outcomes were mean change of visual analog rating scale ( VARS ) and index scores measured through a quality-of-life questionnaire ( EQ-5D ) , and changes in the visual analog scale ( VAS ) , all of which were assessed at each visit . A secondary outcome was the frequency and nature of adverse events and the number of patients who withdrew from the study as a result . RESULTS In the treatment group ( n=10 ) , the mean index score of EQ-5D and VAS changed significantly from the placebo group ( by 0.299 and 2.61 , respectively ) from day 2 ( P < 0.01 ) . The VARS of EQ-5D also disclosed significant changes from day 2 ( 17 , P < 0.01 ) . In addition , efficacy was maintained mainly between days 2 and 60 but declined slightly by day 90 . The most frequently reported treatment-related adverse events in the treatment and placebo groups were local tenderness ( 21 % ) , subcutaneous hemorrhage ( 10.5 % ) , and conjunctivitis ( 10.5 % ) . No severe adverse events were reported during the study or follow-up period . CONCLUSIONS BoNT-A is effective and well tolerated for the treatment of periorbital pain after an AACG attack . Its effects may be maintained for 3 months .

botulinum toxin type A .

botulinum toxin type A ( BoNT-A )

BoNT-A

placebo

placebo

BoNT-A

visual analog scale

mean index score of EQ-5D

VAS

VARS

of

efficacy

local tenderness

subcutaneous hemorrhage

conjunctivitis

severe adverse events

intractable periorbital pain

acute angle closure glaucoma

AACG


A randomized trial of tailored skin cancer prevention messages for adults : Project SCAPE . OBJECTIVES We evaluated the impact of a mailed , tailored intervention on skin cancer prevention and skin self-examination behaviors of adults at moderate and high risk for skin cancer . METHODS Adults at moderate and high risk for skin cancer were recruited in primary health care settings in Honolulu , HI , and Long Island , NY . After completing a baseline survey , participants were randomized to 2 groups . The treatment group received tailored materials , including personalized risk feedback , and the control group received general educational materials . Multivariate analyses compared sun protection and skin self-examination between groups , controlling for location , risk level , gender , and age . RESULTS A total of 596 adults completed the trial . The tailored materials had a significant effect on overall sun-protection habits , the use of hats , the use of sunglasses , and the recency of skin self-examination . Some effects were moderated by location and risk level . CONCLUSIONS Tailored communications including personalized risk feedback can improve sun-protection behaviors and skin self-examination among adults at increased risk for skin cancer . These convenient , low-cost interventions can be implemented in a variety of settings and should be tested further to assess their long-term effectiveness .

mailed , tailored intervention

general educational materials

Tailored communications

skin cancer

skin self-examination behaviors

sun protection

skin self-examination

sun-protection behaviors

skin self-examination

adults :

skin cancer

adults

moderate and high risk for skin cancer

Adults

moderate and high risk for skin cancer

adults

adults

increased risk for skin cancer


Reducing polycystic liver volume in ADPKD : effects of somatostatin analogue octreotide . BACKGROUND AND OBJECTIVES No medical treatment is available for polycystic liver disease , a frequent manifestation of autosomal-dominant polycystic kidney disease ( ADPKD ) . In a prospective , randomized , double-blind , crossover study , 6 months of octreotide ( 40 mg every 28 days ) therapy limited kidney volume growth more effectively than placebo in 12 patients with ADPKD . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS In this secondary , post hoc analysis of the above study , octreotide-induced changes in liver volumes compared with placebo and the relationship between concomitant changes in liver and kidney volumes were evaluated . Those analyzing liver and kidney volumes were blinded to treatment . RESULTS Liver volumes significantly decreased from 1595 +/- 478 ml to 1524 +/- 453 ml with octreotide whereas they did not appreciably change with placebo . Changes in liver volumes were significantly different between the two treatment periods ( -71 +/- 57 ml versus +14 +/- 85 ml ) . Octreotide-induced liver volume reduction was fully explained by a reduction in parenchyma volume from 1506 +/- 431 ml to 1432 +/- 403 ml . Changes in liver volumes were significantly correlated with concomitant changes in kidney volumes ( r = 0.67 ) during octreotide but not during placebo treatment . Liver and kidney volume changes significantly differed with both treatments ( octreotide : -71 +/- 57 ml versus +71 +/- 107 ; placebo : +14 +/- 85 ml versus +162 +/- 114 ) , but net reductions in liver ( -85 +/- 103 ml ) and kidney ( -91 +/- 125 ml ) volume growth on octreotide versus placebo were similar . CONCLUSIONS Octreotide therapy reduces liver volumes in patients with ADPKD and is safe .

somatostatin analogue octreotide

octreotide

placebo

octreotide-induced

placebo

placebo

octreotide

placebo

octreotide

Octreotide therapy

polycystic liver volume

liver volumes

liver and kidney volumes

Liver volumes significantly decreased

Changes in liver volumes

significantly different

parenchyma volume

Changes in liver volumes

kidney volumes

Liver and kidney volume changes

differed

net reductions in liver

kidney

volume growth

similar

liver volumes

polycystic liver volume in ADPKD :


Differential response to resistance training in CHF according to ACE genotype . BACKGROUND The Angiotensin Converting Enzyme ( ACE ) gene may influence the risk of heart disease and the response to various forms of exercise training may be at least partly dependent on the ACE genotype . We aimed to determine the effect of ACE genotype on the response to moderate intensity circuit resistance training in chronic heart failure ( CHF ) patients . METHODS The relationship between ACE genotype and the response to 11weeks of resistance exercise training was determined in 37 CHF patients ( New York Heart Association Functional Class=2.3±0.5 ; left ventricular ejection fraction 28±7 % ; age 64±12years ; 32:5 male : female ) who were randomised to either resistance exercise ( n=19 ) or inactive control group ( n=18 ) . Outcome measures included V˙O ( 2peak ) , peak power output and muscle strength and endurance . ACE genotype was determined using standard methods . RESULTS At baseline , patients who were homozygous for the I allele had higher V˙O ( 2peak ) ( p=0.02 ) and peak power ( p=0.003 ) compared to patients who were homozygous for the D allele . Patients with the D allele , who were randomised to resistance training , compared to non-exercising controls , had greater peak power increases ( ID p < 0.001 ; DD p < 0.001 ) when compared with patients homozygous for the I allele , who did not improve . No significant genotype-dependent changes were observed in V˙O ( 2peak ) , muscle strength , muscle endurance or lactate threshold . CONCLUSION ACE genotype may have a role in exercise tolerance in CHF and could also influence the effectiveness of resistance training in this condition .

resistance training

resistance training

11weeks of resistance exercise training

V˙O ( 2peak )

peak power

V˙O ( 2peak )

muscle strength

muscle endurance

lactate threshold

chronic heart failure

CHF


Vancomycin added to empirical combination antibiotic therapy for fever in granulocytopenic cancer patients . European Organization for Research and Treatment of Cancer ( EORTC ) International Antimicrobial Therapy Cooperative Group and the National Cancer Institute of Canada-Clinical Trials Group . A total of 747 febrile granulocytopenic patients with cancer were randomized to receive ceftazidime plus amikacin ( CA ) with or without vancomycin ( V ) as initial empirical therapy . Single gram-positive bacteremias responded in 29 ( 43 % ) of 68 patients treated with CA and in 48 ( 72 % ) of 67 treated with CAV ( P = .001 ) . For single gram-negative bacteremias and clinically documented and possible infections the response rates of CA and CAV were 80 % and 63 % ( P = .17 ) , 55 % and 75 % ( P = .009 ) , and 74 % and 81 % ( P = .16 ) , respectively . However , for patients with gram-positive bacteremia and for all other patients , there were no differences by treatment regimens in the proportion of febrile patients on each trial day ( P = .85 , P = .82 , respectively ) or in the duration of fever ( P = .22 , P = .93 , respectively ) . Moreover , no patient with gram-positive bacteremia died during the first 3 days of true empirical therapy . Antibiotic-associated nephrotoxicity was more frequent in patients treated with vancomycin ( 6 % vs. 2 % , P = .02 ) . These results do not support the empirical addition of vancomycin to initial antibiotic therapy in cancer patients with fever and granulocytopenia .

Vancomycin

response rates

proportion of febrile patients

duration of fever

died

Antibiotic-associated nephrotoxicity

granulocytopenic cancer patients .


The development of a web- and a print-based decision aid for prostate cancer screening . BACKGROUND Whether early detection and treatment of prostate cancer ( PCa ) will reduce disease-related mortality remains uncertain . As a result , tools are needed to facilitate informed decision making . While there have been several decision aids ( DAs ) developed and tested , very few have included an exercise to help men clarify their values and preferences about PCa screening . Further , only one DA has utilized an interactive web-based format , which allows for an expansion and customization of the material . We describe the development of two DAs , a booklet and an interactive website , each with a values clarification component and designed for use in diverse settings . METHODS We conducted two feasibility studies to assess men 's ( 45-70 years ) Internet access and their willingness to use a web- vs. a print-based tool . The booklet was adapted from two previous versions evaluated in randomized controlled trials ( RCTs ) and the website was created to closely match the content of the revised booklet . Usability testing was conducted to obtain feedback regarding draft versions of the materials . The tools were also reviewed by a plain language expert and the interdisciplinary research team . Feedback on the content and presentation led to iterative modifications of the tools . RESULTS The feasibility studies confirmed that the Internet was a viable medium , as the majority of men used a computer , had access to the Internet , and Internet use increased over time . Feedback from the usability testing on the length , presentation , and content of the materials was incorporated into the final versions of the booklet and website . Both the feasibility studies and the usability testing highlighted the need to address men 's informed decision making regarding screening . CONCLUSIONS Informed decision making for PCa screening is crucial at present and may be important for some time , particularly if a definitive recommendation either for or against screening does not emerge from ongoing prostate cancer screening trials . We have detailed our efforts at developing print- and web-based DAs to assist men in determining how to best meet their PCa screening preferences . Following completion of our ongoing RCT designed to test these materials , our goal will be to develop a dissemination project for the more effective tool . TRIAL REGISTRATION NCT00623090 .

web- and a print-based decision aid

booklet

interactive website

web- vs.

print-based tool .

randomized controlled trials ( RCTs )

website

prostate cancer screening

disease-related mortality

decision making

values and preferences

Usability

Internet

used a computer

access to the Internet

Internet use

feasibility

usability

prostate cancer

men 's

45-70 years


Comparison of neodymium-doped yttrium aluminum garnet laser treatment with cold knife endoscopic incision of urethral strictures in male patients . OBJECTIVE To assess the effectiveness of visual laser ablation treatment with neodymium-doped yttrium aluminum garnet ( Nd : YAG ) laser in male patients with urethral strictures and to compare the effects with those obtained in patients treated with Sachse 's optical urethrotomy . MATERIALS AND METHODS Fifty patients aged 22 to 83 ( mean age 61.8 ) with primary ( n = 26 , 52 % ) and recurrent ( n = 24 , 48 % ) urethral strictures 0.3 to 2.4 cm long qualified for the study . The patients were randomized into two groups : 30 men treated using visual laser ablation of urethral strictures ( VLASU ) with Nd : YAGlaser and 20 men treated by correction of urethral strictures using Sachse 's optical urethrotomy . RESULTS At 12-month follow-up , seven ( 35 % ) patients who underwent optical urethrotomy and 21 ( 70 % ) in the VLASU group did not require repetition of the procedure . The choice of VLASU as a method of treatment significantly decreased the probability of therapeutic failure and recurrence of urethral strictures ( p = 0.02 ) . CONCLUSION VLASU can be used as a method of treatment of this disorder . It is an effective , modern , low-invasive , and repeatable technique and is technically simple and easy to master . It can be used in cases in which introduction of a 22 Char optical urethrotome into the stricture site is impossible , as well as for treatment of multiple strictures during one procedure .

cold knife endoscopic incision

optical urethrotomy

VLASU

VLASU

VLASU

effectiveness

repetition of the procedure .

decreased the

probability of therapeutic failure

and recurrence of urethral strictures


Final analysis of the UKLG LY02 trial comparing 6-8 cycles of CHOP with 3 cycles of CHOP followed by a BEAM autograft in patients < 65 years with poor prognosis histologically aggressive NHL . This trial involved 457 patients and sought to assess the value of early intensification with autologous transplantation in patients with poor prognosis histologically aggressive non-Hodgkin lymphoma ( NHL ) showing a response to initial CHOP ( cyclophosphamide , doxorubicin , vincristine , prednisolone ) chemotherapy . Randomization was made at the time of diagnosis with 223 assigned to continuing CHOP and 234 to 3 cycles of CHOP followed by a BEAM ( carmustine , etoposide , cytarabine , melphalan ) autograft . Analysis was on an intention to treat basis . After the initial three cycles of CHOP 19 % of the whole group were in complete response ( CR ) and 53 % in partial remission ( PR ) . At the end of treatment 86 % of patients in the CHOP arm had responded with 58 % in CR . In the high-dose therapy arm the overall response rate was 83 % with 64 % in CR ( difference between arms not significant ) . The progression-free survival ( PFS ) and overall survival at 5 years for the continuing CHOP arm were 38 % and 50 % respectively , and for the autograft arm were 44 % and 50 % ( differences not significant ) . Of the patients who attained CR and subsequently relapsed , there were no long-term survivors in the autograft recipients compared to 46 % of the continuing CHOP recipients ( P = 0.0008 ) . In conclusion , no survival benefit was demonstrated for an early autograft in first response .

CHOP

CHOP

BEAM autograft

CHOP

CHOP

CHOP

CHOP

CHOP

complete response ( CR )

partial remission ( PR ) .

the overall response rate

relapsed

long-term survivors

< 65 years

NHL

non-Hodgkin lymphoma


Effect of membrane permeability on inflammation and arterial stiffness : a randomized trial . BACKGROUND AND OBJECTIVES Both larger molecule removal and dialyzer biocompatibility have been implicated in the high-flux hemodialysis ( HD ) -associated favorable outcome . In an attempt to delineate the effect of membrane permeability , we performed a randomized , crossover study to compare the inflammatory biomarkers , lipid profile , and aortic pulse wave velocity ( PWV ) of two dialyzers that are composed of identical membranes but with different flux characteristics . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Stable patients who had anuria and were on low-flux polysulfone membrane were randomly allocated either to HD with high-flux polyamide membrane ( group A ; 22 patients ) or to HD with low-flux polyamide membrane ( group B ; 24 patients ) for 24 weeks , then they were started on 24 weeks of the alternative HD treatment . Apart from the dialyzer , the dialysis prescription remained unchanged . RESULTS Nineteen patients from group A and 23 patients from group B completed the study . Predialysis beta ( 2 ) -microglobulin levels decreased significantly when using the high-flux polyamide membrane . No difference between membranes was observed for serum albumin , high-sensitivity C-reactive protein , fibrinogen , IL-6 , triglycerides , HDL cholesterol , LDL cholesterol , and lipoprotein ( a ) during the study . A significant increase in aortic PWV , a marker of aortic stiffness , was noted after patients switched from high-flux to low-flux polyamide membranes . Similarly , the rate of change in aortic PWV was significantly decreased with the use of the high-flux polyamide membrane . CONCLUSIONS Our findings suggest that dialysis with polyamide membranes with different flux characteristics did not modify the inflammatory indices and lipid profile in stable HD patients ; however , a seemingly beneficial effect on aortic stiffness was noted for patients who were maintained on high-flux polyamide membrane .

high-flux hemodialysis

HD with high-flux polyamide membrane

HD with low-flux polyamide membrane

alternative HD treatment

high-flux polyamide membrane

high-flux

low-flux polyamide membranes

high-flux polyamide membrane

polyamide membranes

high-flux polyamide membrane

Effect

rate of change in aortic PWV


Attenuation of hemodynamic responses to laryngoscopy and tracheal intubation during rapid sequence induction : remifentanil vs. lidocaine with esmolol . AIM This study was designed to compare the effectiveness of remifentanil vs. a lidocaine-esmolol combination in blunting the hemodynamic response to laryngoscopy and intubation during rapid sequence induction using thiopental and rocuronium in normotensive patients . METHODS Sixty-six patients with American Society of Anesthesiologists ( ASA ) physical status class I who required tracheal intubation for elective surgery were randomly assigned to one of two groups . Group R received 0.9 % saline 10 ml and remifentanil 1 microg/kg . Group LE received lidocaine 1.5 mg/kg and esmolol 1.0 mg/kg . Anesthesia was induced with thiopental sodium 5 mg/kg , followed by rocuronium 1.0 mg/kg . Mean arterial pressure and heart rate were recorded at baseline , after induction , immediately after intubation and every minute for five minutes after intubation . RESULTS Changes in mean arterial pressure over time between the two groups were significantly different ( P < 0.0001 ) . The maximum pressor response was observed immediately after intubation , at which time the mean arterial pressure change from baseline in group LE ( 29.7 % ) ( 95 % confidence interval [ CI ] : 116.1 , 121.9 ) was higher than that in group R ( 4.4 % ) ( 95 % CI : 92.9 , 98.5 ) ( P < 0.0001 ) . Two patients in group R and 15 patients in group LE developed hypertension ( odds ratio [ OR ] : 0.064 ) ( P < 0.001 ) . Changes in heart rate over time between the two groups were not significantly different ( P=0.465 ) . CONCLUSION The results of this study show that remifentanil 1 mg/kg is more effective than the combination of lidocaine 1.5 mg/kg and esmolol 1 mg/kg for attenuating the hemodynamic responses to rapid sequence intubation .

remifentanil

lidocaine with esmolol

remifentanil

lidocaine-esmolol

thiopental sodium

rocuronium

remifentanil

lidocaine

esmolol

hemodynamic response

Mean arterial pressure and heart rate

mean arterial pressure over time

maximum pressor response

mean arterial pressure change

hypertension

heart rate over time

hemodynamic responses

normotensive

Sixty-six


Promoting social skill development in children with pervasive developmental disorders : a feasibility and efficacy study . A randomized controlled design was employed to evaluate a social skills intervention for children with pervasive developmental disorders . Aims included evaluating the acceptability of the program and gathering preliminary evidence on efficacy . Forty-four children , ages 8-11 years , were randomly assigned to treatment or wait list . Treatment consisted of a 16-week group intervention designed to teach appropriate social behavior . Between group comparisons showed that children in treatment were rated as improved on the primary outcome measure , ( unblinded parent report ) , but not on the secondary outcome measure , a parent questionnaire . Parents reported a high level of satisfaction with the intervention . The study supports the feasibility of this intervention to families and highlights challenges for future research in social skills intervention .

Promoting social skill development

social skills intervention

treatment

wait list

social skills intervention .

unblinded parent report

parent questionnaire

level of satisfaction

children

pervasive developmental disorders

children

pervasive developmental disorders

Forty-four children , ages 8-11 years

Parents


Digestive enzyme supplementation for autism spectrum disorders : a double-blind randomized controlled trial . To examine the effects of a digestive enzyme supplement in improving expressive language , behaviour and other symptoms in children with Autism Spectrum Disorder . Randomized , double-blind placebo-controlled trial using crossover design over 6 months for 43 children , aged 3-8 years . Outcome measurement tools included monthly Global Behaviour Rating Scales , Additional Rating Scales of other symptoms by parents and therapists , and monthly completion of the Rescorla Language Development Survey . Compared with placebo , treatment with enzyme was not associated with clinically significant improvement in behaviour , food variety , gastrointestinal symptoms , sleep quality , engagement with therapist , or the Language Development Survey Vocabulary or Sentence Complexity Scores . A small statistically significant improvement on enzyme therapy was seen for the food variety scores . No clinically significant effect improvement of autism symptoms with enzyme use was shown with this trial , however , possible effects on improvement in food variety warrants further detailed investigation .

Digestive enzyme supplementation

digestive enzyme supplement

placebo-controlled

placebo

enzyme

expressive language

behaviour

other symptoms

Global Behaviour Rating Scales

significant improvement in behaviour

food variety

gastrointestinal symptoms

sleep quality

engagement with therapist

significant improvement

autism symptoms

improvement in food variety

autism spectrum disorders

children

Autism Spectrum Disorder .

3-8 years


A prospective multicenter randomized comparative study between the U- and H-type methods of the TVT SECUR procedure for the treatment of female stress urinary incontinence : 1-year follow-up . BACKGROUND No studies have been published comparing the U- and H-type methods of the TVT SECUR ( TVT-S ) procedure . OBJECTIVE Our aim was to compare the efficacy and safety of the two types of TVT-S for female stress urinary incontinence ( SUI ) . DESIGN , SETTING , AND PARTICIPANTS Women with urodynamic SUI were enrolled in this 12-mo multicenter randomized study . INTERVENTION Subjects were randomly allocated to either the U- or H-type method of TVT-S. MEASUREMENTS Pre- and postoperative evaluations included a standing stress test , the Sandvik questionnaire , the Incontinence Quality of Life ( I-QOL ) questionnaire , and the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms ( ICIQ-FLUTS ) . Patients ' satisfaction and complications were evaluated . Objective and subjective cures were defined as no leakage on the stress test and responses on the Sandvik questionnaire , respectively . We compared the surgical outcomes between the two methods . RESULTS AND LIMITATIONS Of 285 women , 144 had the U-type method and 141 had the H-type method . Objective cure rates were 87.5 % for the U-type method and 80.1 % for the H-type method ( p=0.091 ) . Subjective cure rates were 77.1 % for the U-type method and 75.7 % for the H-type method ( p=0.786 ) . Improvement in I-QOL and domain scores of the ICIQ-FLUTS ( filling and incontinence sum , QOL score ) , and patients ' satisfaction favored the U-type method . There were three cases of intraoperative vaginal wall perforation , one case of increased bleeding , and three cases of temporary postoperative retention . A power calculation was not performed , and some baseline characteristics were not balanced between the two methods . CONCLUSIONS Both methods of TVT-S provided comparable cure rates for female SUI . However , QOL and treatment satisfaction favored the U-type method . TRIAL REGISTRATION The protocol of this study was not registered .

U- or H-type method of TVT-S.

methods of TVT-S

U-type method

standing stress test

Sandvik questionnaire

satisfaction

complications

stress test

Sandvik questionnaire

Objective cure rates

Subjective cure rates

patients ' satisfaction

intraoperative vaginal wall perforation

increased bleeding

temporary postoperative retention

cure rates

QOL

treatment satisfaction

female

stress urinary incontinence

female

stress urinary incontinence ( SUI )

Women

urodynamic SUI

women

SUI


Effect of enamel pretreatment on shear bond strength of brackets bonded with resin-modified glass-ionomer cement . AIM To evaluate the shear bond strength of brackets bonded with resin-modified glass-ionomer cement ( RMGIC ) using various methods of enamel conditioning . METHODS Forty-five human premolars were randomly divided into five groups . The roots of these teeth were fixed in acrylic resin cylinders , and brackets were bonded to the teeth 's crowns using the following material combinations : RMGIC only ; RMGIC and corresponding primer ; RMGIC , acid etching , and Scotchbond Multipurpose ; RMGIC and two-step self-etching primer ; and RMGIC and one-step primer . All specimens were submitted to pH cycling for 14 days before shear bond strength was assessed in a universal test machine . RESULTS The medians and standard deviations ( in MPa ) were RMGIC only = 8.34 ± 1.11 ; RMGIC and corresponding primer = 7.05 ± 2.24 ; RMGIC , acid etching , and Scotchbond Multipurpose = 7.00 ± 4.79 ; RMGIC and two-step self-etching primer = 0.54 ± 0.30 ; and RMGIC and one-step primer = 10.61 ± 4.58 . The value for RMGIC and two-step self-etching primer was significantly lower than all other values . CONCLUSION It can be concluded that the tested RMGIC is suitable for bonding orthodontic brackets , even when used by itself . Different enamel preparations do not improve its performance . However , they can worsen its bonding capacity as the combination with the two-step primer system clearly shows .

enamel pretreatment

enamel

RMGIC

primer

acid etching

Scotchbond

RMGIC

RMGIC

shear bond strength

shear bond strength

bond strength

Forty-five


Comparison of laser photocoagulation for diabetic retinopathy using 532-nm standard laser versus multispot pattern scan laser . PURPOSE The purpose of this study was to compare the efficacy , collateral damage , and convenience of panretinal photocoagulation for proliferative diabetic retinopathy or severe nonproliferative diabetic retinopathy using a 532-nm solid-state green laser ( GLX ) versus a multispot 532-nm pattern scan laser ( PASCAL ) . METHODS This study was a prospective randomized clinical trial . Sixty patients with bilaterally symmetrical proliferative diabetic retinopathy or severe nonproliferative diabetic retinopathy participated . Each patient underwent panretinal photocoagulation : one eye with GLX and the other with PASCAL , two sittings per eye . Grade 3 burns with a 200-mum spot size were placed with both modalities . The fluence , pain using the visual analog scale , time , laser spot spread with infrared images , and retinal sensitivity were compared . RESULTS Pattern scan laser and GLX required an average fluence of 40.33 vs 191 J/cm ( 2 ) , respectively . Average time required per sitting was 1.43 minutes with PASCAL and 4.53 minutes with GLX . Average visual analog scale reading for GLX was 4.6 , whereas that for PASCAL was 0.33 . Heidelberg retinal angiography images showed the spot spread as being 430 versus 310 microm at 3 months with GLX and PASCAL . The eyes treated with PASCAL showed higher average retinal sensitivity in the central 15 degrees and 15 degrees to 30 degrees zones ( 25.08 and 22.08 dB , respectively ) than the eyes treated with GLX ( 23.16 and 17.14 dB ) , respectively . CONCLUSION Pattern scan laser showed lesser collateral damage and similar regression of retinopathy compared with GLX . Pattern scan laser treatment was less time consuming and less painful for the patient compared with GLX .

laser photocoagulation

solid-state green laser ( GLX )

multispot 532-nm pattern scan laser

one eye with GLX

PASCAL

time

laser spot spread

retinal sensitivity

average fluence

Average time required per sitting

Average visual analog scale reading

spot spread

average retinal sensitivity

regression of retinopathy


Comparison of the in vitro and in vivo release of digoxin from four different soft gelatin capsule formulations . A blinded , four-treatment crossover study in 16 normal adult male volunteers compared plasma concentrations and urinary excretion of digoxin , measured by radioimmunoassay , after oral administration of soft gelatin capsule formulations of digoxin . Four 0.4-mg formulations with different in vitro " burst times " and dissolution rates were administered , with 2-week intervals between treatments . The two capsules with lowest in vitro burst times ( 2.9 and 16 min ) gave comparable in vivo results . The other two capsules , with in vitro burst times of 62 and 229 min , produced significant delays in digoxin absorption . In vitro-in vivo correlations were obtained by comparing the logarithm of the in vitro burst time with time to peak plasma level and the time to the first measurable plasma level ( > or = 0 . 05 ng/ml ) . Also , the mean time to peak plasma level correlated with the logarithm of the time required to release either 50 % or 85 % of the digoxin in vitro . No significant changes were found in the amount of digoxin absorbed from each capsule as determined by urinary excretion or AUC0-infinity .

digoxin

capsule formulations

digoxin

dissolution rates

digoxin

in vitro and in vivo release of digoxin

urinary excretion of digoxin

peak plasma level

plasma level

peak plasma level

normal

adult

male


Efficacy and safety of two different testosterone undecanoate formulations in hypogonadal men with metabolic syndrome . AIM To investigate efficacy and safety of two different preparations of testosterone undecanoate ( TU ) in 52 hypogonadal men [ mean age 57 yr and mean testosterone ( T ) < 320 ng/dl ] with metabolic syndrome ( MS ) . SUBJECTS AND METHODS Randomized , double-blind , double-dummy study with three parallel treatment arms [ oral TU ; transdermal placebo gel ( P ) ; im TU ] administration for 12 months ( mo ) . Each subject was randomized ( 1:1:3 ) to receive either oral TU ( 2 capsules of 40 mg/twice per day at breakfast and dinner , equalling a total dose of 160 mg/day ; no.=10 ) for 6 mo and continued with im TU for further 6 mo , or P ( 3-4 g/day ; no.=10 ) and im TU ( 1000 mg/12 weeks from week 6 ; no.=32 ) for 12 mo . RESULTS After 6 mo , im TU increased T and free- T levels ( p < 0.0001 ) , and improved metabolic parameters [ reduction in Homeostasis Model Assessment ( HOMA ) index , p < 0.0001 ; waist circumference and fat mass , p < 0.001 , respectively ] , in International Index of Erectile Function-5 and Aging Males ' Symptoms scores ( p < 0.01 , respectively ) . After 12 months , im TU produced further increases in T and free- T levels ( p < 0.0001 ) and metabolic parameters ( reduction in HOMA-index , p < 0.0001 ; waist circumference p < 0.0001 ; fat mass , p < 0.001 ) . No major adverse event due to T treatment occurred . CONCLUSIONS Clinical efficacy of T replacement therapy in hypogonadal men with MS is reached when its plasmatic levels approach into the medium-high range of normality ( > 5 ng/ml ) , although subjective threshold values may be different . Administration of im TU was more effective than oral TU to reach the target for T levels and to improve MS parameters . TU was safe over 12 months and discontinuation rates were similar to placebo .

transdermal placebo gel

oral TU

P

im TU

im TU

TU

placebo

T and free- T levels

metabolic parameters

waist circumference and fat mass

T and free- T levels

metabolic parameters

HOMA-index

waist circumference

fat mass

T levels

hypogonadal

men

metabolic syndrome

hypogonadal

men

age

57 yr

metabolic syndrome ( MS )

hypogonadal

men

MS


The limit to exercise tolerance in humans : mind over muscle ? In exercise physiology , it has been traditionally assumed that high-intensity aerobic exercise stops at the point commonly called exhaustion because fatigued subjects are no longer able to generate the power output required by the task despite their maximal voluntary effort . We tested the validity of this assumption by measuring maximal voluntary cycling power before ( mean +/- SD , 1,075 +/- 214 W ) and immediately after ( 731 +/- 206 W ) ( P < 0.001 ) exhaustive cycling exercise at 242 +/- 24 W ( 80 % of peak aerobic power measured during a preliminary incremental exercise test ) in ten fit male human subjects . Perceived exertion during exhaustive cycling exercise was strongly correlated ( r = -0.82 , P = 0.003 ) with time to exhaustion ( 10.5 +/- 2.1 min ) . These results challenge the long-standing assumption that muscle fatigue causes exhaustion during high-intensity aerobic exercise , and suggest that exercise tolerance in highly motivated subjects is ultimately limited by perception of effort .

high-intensity aerobic exercise

exhaustive cycling exercise

exhaustive cycling exercise

maximal voluntary cycling power

Perceived exertion

time to exhaustion


Argatroban for elective percutaneous coronary intervention : the ARG-E04 multi-center study . UNLABELLED The synthetic arginine-derived direct thrombin inhibitor argatroban is an attractive anticoagulant for percutaneous coronary intervention ( PCI ) , because of its rapid onset and offset , and its hepatic elimination . Argatroban was approved for PCI in patients with heparin-induced thrombocytopenia ( HIT ) . However , there are limited data about argatroban in non-HIT patients . The objective of this open-label , multiple-dose , controlled study was to examine the safety and efficacy of argatroban in patients undergoing elective PCI . METHODS AND RESULTS Of 140 patients randomized to three argatroban dose groups ( ARG250 , ARG300 , and ARG350 with 250 , 300 , or 350 μg/kg bolus , followed by 15 , 20 , or 25 μg/kg/min infusion ) and one unfractionated heparin ( UFH ) group ( 70-100 IU/kg bolus ) , 138 patients were analyzed . Argatroban dose-dependently prolonged activated clotting time ( ACT ) with more patients reaching the minimum target ACT after the initial bolus injection ( ARG250 : 86.1 % , ARG300 : 89.5 % , and ARG350 : 96.8 % ) compared to 45.5 % in UFH ( p < 0.001 ) . The patient proportion who did not require additional bolus injections to start PCI was significantly higher in argatroban than in UFH ( p ≤ 0.002 ) . Consequently , the time to start of PCI was shortened in argatroban groups . Composite incidences of death , myocardial infarction , and urgent revascularization until day 30 were not significantly different between the groups ( ARG250 : 2.8 % , ARG300 : 0.0 % , ARG350 : 3.2 % vs. UFH : 3.0 % ) . Major bleeding was observed only in UFH ( 3.0 % ) , while minor bleeding occurred in ARG350 ( 3.2 % ) and UFH ( 6.1 % , n.s. ) . CONCLUSION Argatroban dose-dependently increases coagulation parameters and , compared to UFH , demonstrates a superior predictable anticoagulant effect in patients undergoing elective PCI .

Argatroban

argatroban

Argatroban

argatroban

argatroban

argatroban

safety and efficacy

activated clotting time ( ACT )

additional bolus injections

time to start of

death

bleeding

minor bleeding


The unconscious thought effect in clinical decision making : an example in diagnosis . The unconscious thought effect refers to improved judgments and decisions after a period of distraction . The authors studied the unconscious thought effect in a complex and error-prone part of clinical decision making : diagnosis . Their aim was to test whether conscious versus unconscious processing influenced diagnosis of psychiatric cases . They used case descriptions from the DSM-IV casebook . Half of the participants were randomly assigned to the conscious-processing-condition ( i.e. , consciously thinking about the information they read in the case description ) , the other half to the unconscious-processing condition ( i.e. , performing an unrelated distracter task ) . The main dependent measure was the total number of correct classifications . Compared to conscious processing , unconscious processing significantly increased the number of correct classifications . The results show the potential merits of unconscious processing in diagnostic decision making .

conscious-processing-condition

unconscious-processing condition

total number of correct classifications

number of correct classifications

diagnostic decision making


PSK may suppress CD57 ( + ) T cells to improve survival of advanced gastric cancer patients . BACKGROUND A recent report showed that oral adjuvant immunochemotherapy with protein-bound polysaccharide K ( PSK ) and tegafur/uracil ( UFT ) for stage II and III colorectal cancer improves overall survival compared with UFT alone . PSK has been supposed to improve survival through immunological mechanisms such as induction of cytokines , regulation of Th1/Th2 balance , and inhibition of immunosuppressive molecules . METHODS We investigated the mechanisms by which PSK influences immunological parameters such as Th1 cells ( IFN-gamma-positive CD4 ( + ) T cells ) , Th2 cells ( IL-4-positive CD4 ( + ) T cells ) , Th1/Th2 ratio , NKT cells ( CD56 ( + ) T cells and CD57 ( + ) T cells ) , NK cells , and CD25 ( + ) CD4 ( + ) T cells in stage III gastric cancer patients . Patients were randomly assigned to receive either 3 g PSK plus 300 mg UFT ( PSK group ) or 300 mg UFT alone ( control ) orally each day for at least 1 year following their operation . RESULTS Twenty-one registered patients with stage III gastric cancer were analyzed . The 3-year overall survival was 62.2 % in the PSK group ( n = 10 ) and 12.5 % in the control group ( n = 11 ) ( P = 0.038 ) . Before operation , there were no significant differences in the proportions of Th1 cells , Th2 cells , Th1/Th2 ratio , CD56 ( + ) T cells , CD57 ( + ) T cells , NK cells , and CD4 ( + ) CD25 ( + ) T cells between PSK and control groups . However , after operation , CD57 ( + ) T cells decreased significantly in the PSK group compared to the control ( P = 0.0486 ) . When all patients were analyzed , patients with increased proportion ( > 18 % ) of CD57 ( + ) T cells showed worse survival than those with lower ( < or = 18 % ) CD57 ( + ) T cells ( 3-year survival , 25.0 and 45.7 % , respectively ; P = 0.046 ) , consistent with our previous report that high CD57 ( + ) is an indicator of poor prognosis in patients with advanced gastric cancer . However , in the group treated with PSK + UFT , 3-year survival of CD57-high patients was as great as that of CD57-low patients ( 66.7 and 51.4 % , respectively ; P = 0.67 ) . CONCLUSION The present findings suggest that PSK improves overall survival of stage III gastric cancer patients partly by inhibiting CD57 ( + ) T cells , a proven poor prognostic factor in advanced gastric cancer .

PSK

oral adjuvant immunochemotherapy

protein-bound polysaccharide K ( PSK )

tegafur/uracil ( UFT )

UFT

PSK

PSK

PSK plus 300 mg UFT ( PSK group )

UFT alone

PSK

control

PSK

PSK + UFT

PSK

immunological parameters

3-year overall survival

CD57 ( + ) T cells

3-year survival


RCT of a manualized social treatment for high-functioning autism spectrum disorders . This RCT examined the efficacy of a manualized social intervention for children with HFASDs . Participants were randomly assigned to treatment or wait-list conditions . Treatment included instruction and therapeutic activities targeting social skills , face-emotion recognition , interest expansion , and interpretation of non-literal language . A response-cost program was applied to reduce problem behaviors and foster skills acquisition . Significant treatment effects were found for five of seven primary outcome measures ( parent ratings and direct child measures ) . Secondary measures based on staff ratings ( treatment group only ) corroborated gains reported by parents . High levels of parent , child and staff satisfaction were reported , along with high levels of treatment fidelity . Standardized effect size estimates were primarily in the medium and large ranges and favored the treatment group .

social treatment

manualized social intervention

treatment

wait-list conditions .

parent ratings

staff ratings

parent , child and staff satisfaction

treatment fidelity .

children with HFASDs .


Aminocaproic acid versus prednisone for the treatment of traumatic hyphema . A randomized clinical trial . One hundred twelve patients who sustained hyphema after blunt trauma were enrolled in a double-blind randomized clinical trial to determine the relative efficacies of aminocaproic acid ( Amicar ) and systemic prednisone for reducing the rate of secondary hemorrhage . Fifty-six patients received an oral dosage of 50 mg/kg of aminocaproic acid every 4 hours for 5 days , up to a maximum of 30 g daily , and 56 patients received an oral dosage of 40 mg of prednisone daily ( adjusted for weight ) in two divided doses . Placebo pills and liquids were given to each patient to mask the treatment schedules . There were no statistically significant differences between the patient populations for any demographic or clinical characteristic ( e.g. , visual acuity , intraocular pressure [ IOP ] , initial hyphema size ) measured in the study . Blacks comprised 53 % of the study population , and the mean age of the patients was 23.5 years . Four patients in each of the treatment groups experienced a secondary hemorrhage ; the rebleed rate was 7.1 % in each group .

Aminocaproic acid

prednisone

aminocaproic acid ( Amicar )

systemic prednisone

aminocaproic acid

prednisone

Placebo

rate of secondary hemorrhage

visual acuity

intraocular pressure [ IOP ]

initial hyphema size

secondary hemorrhage

rebleed rate

traumatic hyphema

One hundred twelve

sustained hyphema after blunt trauma

mean age of the patients was 23.5 years


Effect of topical anesthesia and age on pain scores during retinopathy of prematurity screening . OBJECTIVE The efficacy of topical anesthesia during retinopathy of prematurity ( ROP ) screening has been a controversial issue . To determine the efficacy of proparacaine eye drops ( 0.5 % ) , we compared the Premature Infant Pain Profile ( PIPP ) scores in 40 preterm infants undergoing ROP screening . STUDY DESIGN Prospective randomized double masked cross-over clinical trial . The study was conducted in the neonatal intensive units for infants undergoing routine ROP screening exams . Baseline PIPP scores and post-examination PIPP scores at 1 and 5 min were compared for : ( 1 ) those receiving saline vs proparacaine eye drops ( 2 ) first ROP screening vs second ROP screening , regardless of the type of eye drops used . Wilcoxon signed-ranks test was used to pair pain scores . RESULT Forty preterm infants were included in the study . Mean gestational age ( GA ) at first and second examinations was 33.3 and 35.3 weeks , respectively . Proparacaine use significantly lowered mean PIPP scores ( P=0.027 ) and delta scores ( P=0.013 ) at 1 min after examination , but there was no difference at 5 min after examination . Second examinations showed significantly lower mean PIPP scores after examination ( 1 min ( P=0.003 ) and 5 min ( P=0.025 ) ) , regardless of the type of drop used . CONCLUSION Proparacaine eye drops offer significant relief of pain that is apparently short lived . Significantly lower PIPP scores at second ROP examinations suggested that infants of older GA may have a greater ability to tolerate ROP screening . We recommend the use of proparacaine eye drops for the short term , immediate relief of pain during ROP screening in preterm infants of lesser GA .

topical anesthesia

topical anesthesia

proparacaine eye drops

pain scores

efficacy

efficacy

Premature Infant Pain Profile ( PIPP )

Baseline PIPP scores

post-examination PIPP scores

retinopathy of prematurity ( ROP )

infants

ROP


Efficacy and safety of a high protein , low carbohydrate diet for weight loss in severely obese adolescents . OBJECTIVE To evaluate the efficacy and safety of a carbohydrate restricted versus a low fat diet on weight loss , metabolic markers , body composition , and cardiac function tests in severely obese adolescents . STUDY DESIGN Subjects were randomly assigned to 1 of 2 diets : a high protein , low carbohydrate ( 20 g/d ) diet ( high protein , low carbohydrate , HPLC ) or low fat ( 30 % of calories ) regimen for 13 weeks ; close monitoring was maintained to evaluate safety . After the intervention , no clinical contact was made until follow-up measurements were obtained at 24 and 36 weeks from baseline . The primary outcome was change in body mass index Z-score for age and sex ( BMI-Z ) at 13 , 24 , and 36 weeks . RESULTS Forty-six subjects ( 24 HPLC , 22 in low fat ) initiated and 33 subjects completed the intervention ; follow-up data were available on approximately half of the subjects . Significant reduction in ( BMI-Z ) was achieved in both groups during intervention and was significantly greater for the HPLC group ( P = .03 ) . Both groups maintained significant BMI-Z reduction at follow-up ; changes were not significantly different between groups . Loss of lean body mass was not spared in the HPLC group . No serious adverse effects were observed related to metabolic profiles , cardiac function , or subjective complaints . CONCLUSIONS The HPLC diet is a safe and effective option for medically supervised weight loss in severely obese adolescents .

high protein , low carbohydrate diet

low fat ( 30 % of calories ) regimen

HPLC

weight loss

metabolic markers

body composition

cardiac function tests

change in body mass index Z-score

BMI-Z

BMI-Z

BMI-Z reduction

lean body mass

serious adverse effects

metabolic profiles

cardiac function

severely obese adolescents .

severely obese adolescents .

Forty-six

severely obese adolescents .


Short-term effects of systemic antibiotics during periodontal healing . OBJECTIVES To investigate the short-term effects of nonsurgical therapy ( scaling and root planing , SRP ) on the subgingival microbiota in chronic ( CP ) and aggressive ( AP ) periodontal disease . METHOD AND MATERIALS Ninety-seven CP and AP subjects underwent full-mouth SRP on 2 consecutive days . AP patients were randomly assigned to either receive systemic metronidazole plus amoxicillin ( AP+AB ) or were treated mechanically alone ( AP ) . Pathogens were identified with 16S rRNA oligodeoxynucleotide probes and dot-blot hybridization before and at days 2 , 3 , 4 , 7 , 10 , and 21 of healing . CP subjects were treated by scaling and root planing along with placebo tablets . RESULTS Initially , AP cell counts were 69.9- ( Porphyromonas gingivalis ) , 10.2- ( Aggregatibacter actinomycetemcomitans ) , 5.7- ( Tannerella forsythia ) , and 3.3-fold ( Prevotella intermedia ) enhanced compared to CP cell counts . Following SRP , immediate elimination occurred in single individuals of all three treatment groups at day 2 . After SRP plus antibiotic therapy ( AP+AB ) , the prevalence scores dropped beyond the levels of AP and CP , beginning at day 7 , and remained low until day 21 ( P =or < .05 ) . Clinical healing statistically benefited from SRP with no differences among the three treatment groups . CONCLUSION Nonsurgical therapy resulted in both a suppression and early elimination of single taxa immediately after completion of active treatment . Systemic antibiotics significantly accelerate the suppression of the periodontal microflora , but have limited effect on the elimination of target isolates during healing .

antibiotics

treated mechanically alone ( AP )

placebo tablets .

SRP plus antibiotic therapy

effects

AP cell counts

SRP plus antibiotic therapy

AP

CP

Clinical healing

single taxa

periodontal microflora

periodontal healing .


Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention : protocol of a cluster randomized multicenter trial . BACKGROUND Pain is one of the most frequent and distressing symptoms in cancer patients . For the majority of the patients , sufficient pain relief can be obtained if adequate treatment is provided . However , pain remains often undertreated due to institutional , health care professional and patient related barriers . Patients self management skills are affected by the patients ' knowledge , activities and attitude to pain management . This trial protocol is aimed to test the SCION-PAIN program , a multi modular structured intervention to improve self management in cancer patients with pain . METHODS 240 patients with diagnosed malignancy and pain > 3 days and average pain > or= 3/10 will participate in a cluster randomized trial on 18 wards in 2 German university hospitals . Patients from the intervention wards will receive , additionally to standard pain treatment , the SCION-PAIN program consisting of 3 modules : pharmacologic pain management , nonpharmacologic pain management and discharge management . The intervention will be conducted by specially trained oncology nurses and includes components of patient education , skills training and counseling to improve self care regarding pain management beginning with admission followed by booster session every 3rd day and one follow up telephone counseling within 2 to 3 days after discharge . Patients in the control group will receive standard care . Primary endpoint is the group difference in patient related barriers to management of cancer pain ( BQII ) , 7 days after discharge . Secondary endpoints are : pain intensity & interference , adherence , coping and HRQoL . DISCUSSION The study will determine if the acquired self management skills of the patients continue to be used after discharge from hospital . It is hypothesized that patients who receive the multi modular structured intervention will have less patient related barriers and a better self management of cancer pain . TRIAL REGISTRATION ClinicalTrials NCT00779597 .

standard pain treatment

group difference in patient related

barriers to management of cancer pain

cancer pain .


[ Effect of zengjing no . 1 capsule on morphology and motility of sperm in patients with oligospermia ] . OBJECTIVE To explore the effect of Zengjing Capsule No . 1 ( ZJC1 ) on morphology and motility of sperm in patients with oligospermia ( OSM ) . METHODS Seventy-two OSM patients were assigned to 2 groups by a randomizing digital table , the treated group and the control group , they were treated respectively by ZJC1 and Wuzi Yanzong Pill ( WYP ) . The changes of density , motility and morphology of sperm in patients before and after 3-month treatment were examined using computerized WLJY-9000 colour semen analysis system with refined Papanicolaou 's stain . RESULTS The density , motility and morphology of sperm were improved and sperm deformity rate was significantly decreased after treatment in both groups ( P < 0.01 ) , but the effects in the treated group were better than those in the control group ( P < 0.01 ) . CONCLUSION ZJC1 can enhance the density and motility of sperm and reduce the sperm deformity rate in patients with OSM .

zengjing no . 1 capsule

Zengjing Capsule No . 1 ( ZJC1 )

Wuzi Yanzong Pill

morphology and motility of sperm

semen analysis system

sperm deformity rate

density and motility of sperm

sperm deformity rate

patients with OSM .


The role of adjunctive exenatide therapy in pediatric type 1 diabetes . OBJECTIVE Exenatide improves postprandial glycemic excursions in type 2 diabetes . Exenatide could benefit type 1 diabetes as well . We aimed to determine an effective and safe glucose-lowering adjuvant exenatide dose in adolescents with type 1 diabetes . RESEARCH DESIGN AND METHODS Eight subjects completed a three-part double-blinded randomized controlled study of premeal exenatide . Two doses of exenatide ( 1.25 and 2.5 microg ) were compared with insulin monotherapy . Prandial insulin dose was reduced by 20 % . Gastric emptying and hormones were analyzed for 300 min postmeal . RESULTS Treatment with both doses of exenatide versus insulin monotherapy significantly reduced glucose excursions over 300 min ( P < 0.0001 ) . Exenatide administration failed to suppress glucagon but delayed gastric emptying ( P < 0.004 ) . CONCLUSIONS Adjunctive exenatide therapy reduces postprandial hyperglycemia in adolescents with type 1 diabetes . This reduction in glucose excursion occurs despite reduction in insulin dose . We suggest that exenatide has therapeutic potential as adjunctive therapy in type 1 diabetes .

adjunctive exenatide therapy

Exenatide

Exenatide

exenatide

insulin monotherapy

insulin

exenatide

insulin monotherapy

Exenatide

exenatide

exenatide

glycemic excursions

glucose-lowering

reduced glucose excursions

reduces postprandial hyperglycemia

glucose excursion

pediatric

type 1 diabetes .

adolescents

type 1 diabetes

Eight

adolescents


CD4+FOXP3+ regulatory T cell depletion by low-dose cyclophosphamide prevents recurrence in patients with large condylomata acuminata after laser therapy . Condylomata acuminata ( CA ) caused by human papillomavirus ( HPV ) is a common sexually transmitted disease with half a million new cases diagnosed in the United States per year and the annual increase in incidence in China . Recurrence is a major challenge for CA treatment . Recently , we demonstrated that FOXP3 ( + ) regulatory T ( Treg ) cells mediate the immunosuppression in large genital warts . Here , we further report that low-dose cyclophosphamide ( CY ) , a conventional chemotherapy drug , can effectively prevent the recurrence of large CA in clinical patients after laser therapy . Surprisingly , although 9 out of 52 patients recur six weeks after the combination treatment , the re-administration of low-dose CY alone completely eliminates most recurred lesions . We provide evidence that low-dose CY not only depletes patients ' Treg cells and enhances function of HPV-specific T cells and NK cells in the periphery , but also ameliorates the immune milieu of the lesion site , leading to the elimination of remnant viruses . These findings have important clinical significance , and potentially lead to a therapeutic breakthrough for the treatment of CA .

cyclophosphamide

laser therapy

low-dose cyclophosphamide ( CY )

laser therapy .

CY

CY

recurrence

Recurrence

recurrence of large CA

recurred lesions

patients ' Treg cells

immune milieu of the lesion site


[ Observation of curative effect on fixed-point spin reduction of spinal manipulation therapy for cervical vertigo ] . OBJECTIVE To explore the role of fixed-point spin reduction of spinal manipulation therapy in the treatment of cervical vertigo and its effect on cervical artery spasm index ( RI ) and atlantoaxial displacement index ( ADI ) . METHODS From January 2002 to May 2008 , 168 patients with cervical vertigo were randomly divided into treatment group ( 84 cases ) and the control group ( 84 cases ) , 22 males and 62 females in treatment group ; 24 males and 60 females in control group . The patients of treatment group and control group were respectively treated with fixed-point spin reduction of spinal manipulation therapy and dialectical prescription . The score of symptoms and signs , RI , ADI were observed and compared between two groups . RESULTS The score of symptoms and signs markedly decreased after treatment , in treatment group : vertigo had ( 2.75 +/- 1.01 ) scores , neck-shoulder pain ( 1.58 +/- 0.36 ) , headache ( 0.39 +/- 0.09 ) , nausea-vomiting ( 1.58 +/- 1.30 ) , ear noises ( 0.48 +/- 0.32 ) , positive neck rotation test ( 0.59 +/- 0.21 ) ; and in control group : vertigo had ( 5.68 +/- 2.02 ) scores , neck-shoulder pain ( 3.12 +/- 1.82 ) , headache ( 1.86 +/- 0.65 ) , nausea-vomiting ( 3.25 +/- 0.69 ) , ear noises ( 1.64 +/- 0.61 ) , positive neck rotation test ( 1.79 +/- 0.67 ) . Cervical artery spasm index and atlantoaxial displacement index had been significantly improved , cervical artery spasm index was respectively 0.54 +/- 0.07 and 0.52 +/- 0.13 , atlantoaxial displacement index was respectively 2.92 +/- 0.82 and 4.50 +/- 1.32 between treatment group and control group . CONCLUSION Fixed-point spin reduction of spinal manipulation therapy for cervical vertigo can accurately correct single or multiple vertebral body displacement , restore normal spinal position , reduce the oppression and stimulus of the vertebral artery , release ischemia of vestibular labyrinth , eliminate symptoms of vertigo .

spinal manipulation therapy

spinal manipulation therapy

dialectical prescription

spinal manipulation therapy

score of symptoms and signs

vertigo

neck-shoulder pain

headache

nausea-vomiting

ear noises

positive neck rotation test

vertigo

neck-shoulder pain

headache

nausea-vomiting

ear noises

positive neck rotation test

cervical artery spasm index

atlantoaxial displacement index

cervical vertigo

cervical vertigo

84 cases

84 cases

22 males and 62 females

24 males and 60 females

vertebral body displacement


Comparison of yoga versus stretching for chronic low back pain : protocol for the Yoga Exercise Self-care ( YES ) trial . BACKGROUND Back pain , one of the most prevalent conditions afflicting American adults , is the leading reason for using complementary and alternative medicine ( CAM ) therapies . Yoga is an increasingly popular " mind-body " CAM therapy often used for relieving back pain and several small studies have found yoga effective for this condition . This study will assess whether yoga is effective for treating chronic low back pain compared with self care and exercise and will explore the mechanisms responsible for any observed benefits . METHODS/DESIGN A total of 210 participants with low back pain lasting at least 3 months will be recruited from primary care clinics of a large healthcare system based in Seattle . They will be randomized in a 2:2:1 ratio to receive 12 weekly yoga classes , 12 weekly conventional therapeutic exercise classes of comparable physical exertion , or a self-care book . Interviewers masked to participants ' treatment group will assess outcomes at baseline and 6 , 12 and 26 weeks after randomization . Primary outcomes will be back-related dysfunction and symptom bothersomeness . In addition , data will be collected on physical measurements ( e.g. , flexion ) at baseline and 12 weeks and saliva samples will be obtained at baseline , 6 and 12 weeks . Information will be collected on specific physical , psychological , and physiological factors to allow exploration of possible mechanisms of action through which yoga could relieve back pain and dysfunction . The effectiveness of yoga will be assessed using analysis of covariance ( using general estimating equations - GEE ) within an intention-to-treat context . If yoga is found effective , further analyses will explore whether yoga 's benefits are attributable to physical , psychological and/or physiological factors . CONCLUSIONS This study will provide the clearest evidence to date about the value of yoga as a therapeutic option for treating chronic back pain , and if the results are positive , will help focus future , more in-depth , research on the most promising potential mechanisms of action identified by this study .

yoga versus stretching

Yoga

yoga

self care

exercise

self-care book

yoga

yoga

yoga

yoga

chronic low back pain

Back pain

relieving back pain

chronic low back pain

back-related dysfunction

symptom bothersomeness

physical measurements

flexion

relieve back pain and dysfunction .

chronic back pain

chronic low back pain

low back pain

chronic back pain


Metformin , naltrexone , or the combination of prednisolone and antiandrogenic oral contraceptives as first-line therapy in hyperinsulinemic women with polycystic ovary syndrome . To compare the short-term effects of metformin ( M ) , naltrexone ( N ) , and a combination of OC and prednisolone ( OC/Pr ) on the metabolic state and the ovarian function of PCOS women , we randomized 29 women to a 3-month course of therapy . We observed significant improvements in hyperandrogenemia and ovulation rates in PCOS women of all three groups , in the absence of changes in the metabolic state , suggesting that insulin resistance in PCOS patients is only one of several factors leading to hyperandrogenemic ovarian failure .

metabolic state

ovarian function

hyperandrogenemia and ovulation rates

metabolic state

women

polycystic ovary syndrome

PCOS

women

women

PCOS


Effect of ranolazine on A1C and glucose levels in hyperglycemic patients with non-ST elevation acute coronary syndrome . OBJECTIVE We determined the relationships between glycemia at randomization , concurrent antidiabetic therapy , and change in A1C and fasting plasma glucose ( FPG ) in patients with diabetes receiving standard treatment for diabetes and randomized to ranolazine or placebo within the MERLIN-TIMI-36 ( MERLIN ) study . Ranolazine is a novel first-in-class drug approved for treating angina pectoris . RESEARCH DESIGN AND METHODS Randomization and 4-month glycemic and antidiabetes drug usage data from MERLIN were analyzed using Spotfire and SAS version 9.1 software . RESULTS In patients with diabetes and A1C of > or=8-10 % at randomization ( n = 171 ) , there was an absolute A1C reduction in the ranolazine group of 1.2 % ( 95 % CI -1.4 to -1.0 ) , and the placebo-adjusted ( n = 182 ) decrease in A1C by ranolazine was 0.59 % ( 95 % CI -0.99 to -0.20 , P < 0.001 ) . In patients with FPG of 150-400 mg/dl at randomization , ranolazine ( n = 131 ) compared with placebo ( n = 147 ) reduced FPG by 25.7 mg/dl ( 95 % CI -43.3 to -8.1 , P = 0.001 ) . When changes in either A1C or FPG were correlated to A1C or FPG at randomization , the slopes were significantly steeper for ranolazine than placebo ( A1C , P = 0.046 ; FPG , P < 0.001 ) , indicating that lowering of A1C and FPG by ranolazine is related to hyperglycemia at randomization . Ranolazine , compared with placebo , was not associated with serious hypoglycemic events , associated with significant changes in concurrent antidiabetic therapy , or dependent on a history of angina . CONCLUSIONS Ranolazine , when added to concurrent antidiabetes treatment , lowers FPG and A1C in patients with cardiovascular disease and poorly controlled diabetes .

ranolazine

ranolazine

placebo

Ranolazine

glycemic

antidiabetes drug usage

ranolazine

placebo-adjusted

ranolazine

placebo

ranolazine

placebo

ranolazine

Ranolazine

A1C reduction

A1C or FPG

A1C or FPG

A1C and FPG

serious hypoglycemic events

concurrent antidiabetic therapy

history of angina

FPG and A1C

hyperglycemic patients

acute coronary syndrome

diabetes


The effect of prophylactic fentanyl on shivering in elective caesarean section under epidural analgesia . The aims of this randomised double-blind study were to investigate whether 25 micrograms of fentanyl administered prophylactically by the epidural route would influence the incidence of shivering in parturients who underwent elective Caesarean section under epidural analgesia and whether it would affect the axillary and calf temperatures . There was a 50 % reduction ( p less than 0.05 ) in the overall incidence of shivering in patients who received fentanyl and there was some evidence to suggest that low-dose epidural fentanyl might reduce shivering by an influence on thermoregulation .

prophylactic fentanyl

fentanyl

fentanyl

shivering in elective caesarean section

incidence of shivering

axillary and calf temperatures .

incidence of shivering

shivering

thermoregulation .

shivering

parturients

underwent elective Caesarean section

epidural analgesia


Effect of zoledronic acid on disseminated tumour cells in women with locally advanced breast cancer : an open label , randomised , phase 2 trial . BACKGROUND Treatment with bisphosphonates decreases bone loss and can increase disease-free survival in patients with breast cancer . The aim of our study was to assess the effect of zoledronic acid on clearance of disseminated tumour cells ( DTCs ) from the bone marrow in women undergoing neoadjuvant chemotherapy for breast cancer . METHODS Patients were recruited for this open-label , phase 2 randomised trial between March 17 , 2003 , and May 19 , 2006 , at a single centre . Eligible patients had clinical stage II-III ( > or = T2 and/or > or = N1 ) newly diagnosed breast cancer , Eastern Cooperative Oncology Group performance status of 0 or 1 , and normal cardiac , renal , and liver function . 120 women were randomly assigned , using allocation concealment , to receive 4 mg zoledronic acid intravenously every 3 weeks ( n=60 ) , or no zoledronic acid ( n=60 ) , for 1 year concomitant with four cycles of neoadjuvant epirubicin ( 75 mg/m ( 2 ) ) plus docetaxel ( 75 mg/m ( 2 ) ) and two cycles of adjuvant epirubicin plus docetaxel . The primary endpoint was the number of patients with detectable DTCs at 3 months . Final analysis was done 1 year after the last patient was enrolled . Analyses were done for all patients with available data at 3 months . This study is registered with ClinicalTrials.gov , number NCT00242203 . FINDINGS Of the 120 patients initially enrolled , one withdrew after signing consent and one patient 's baseline bone marrow was not available . Both of these patients were in the control group . At 3 months , 109 bone-marrow samples were available for analysis . In the zoledronic acid group , bone marrow was not collected from one patient because of disease progression , one patient was taken off study because of severe diarrhoea , and two patients had not consented at the time of surgery . In the control group , bone marrow was not collected from two patients because of disease progression , one patient withdrew consent , and three patients were not consented at the time of surgery . At baseline , DTCs were detected in 26 of 60 patients in the zoledronic acid group and 28 of 58 patients in the control group . At 3 months , 17 of 56 patients receiving zoledronic acid versus 25 of 53 patients who did not receive zoledronic acid had detectable DTCs ( p=0.054 ) . The most common grade 3-4 toxicities were infection ( five of 60 patients in the zoledronic acid group and six of 59 in the control group ) and thrombosis ( five of 60 in the zoledronic acid and two of 59 in the control group ) . There was one documented case of osteonecrosis in the zoledronic acid group . INTERPRETATION Zoledronic acid administered with chemotherapy resulted in a decreased proportion of patients with DTCs detected in the bone marrow at the time of surgery . Our study supports the hypothesis that the antimetastatic effects of zoledronic acid may be through effects on DTCs . FUNDING Novartis Pharmaceuticals and Pfizer Inc .

zoledronic acid

bisphosphonates

zoledronic acid

no zoledronic acid

four cycles of neoadjuvant epirubicin

docetaxel

zoledronic acid

Zoledronic acid

zoledronic acid

disseminated tumour cells ( DTCs )

detectable DTCs

osteonecrosis

women

locally advanced breast cancer

breast cancer

women

neoadjuvant chemotherapy

breast cancer

women

one

one

baseline bone marrow

bone-marrow samples


Double-blind placebo-controlled comparison of the analgesic effects of single doses of lornoxicam and aspirin in patients with postoperative dental pain . The pain experienced after third molar surgery was used as a model to evaluate the analgesic efficacy of a new non-steroidal anti-inflammatory drug , lornoxicam , in a Phase II study . One hundred and fifty fit , young adults participated in this randomised , single dose , double-blind , parallel group clinical study . Three doses of lornoxicam ( 2 mg , 4 mg , and 8 mg ) were compared with aspirin 650 mg and placebo . Patients suffering from moderate to severe pain following surgery were monitored for up to 8 hours . All indices of efficacy showed similar results , all active treatments being associated with highly significant ( P less than 0.0001 ) reductions in pain during the study period . Lornoxicam 8 mg demonstrated significant analgesic efficacy as compared with placebo . The two lower doses of lornoxicam and aspirin all showed apparent degrees of efficacy intermediate between that of placebo and lornoxicam 8 mg , although the trial proved to have inadequate power to show significant differences between these three treatments . Lornoxicam was very well tolerated at all three doses studied , with no adverse events definitely attributable to its administration .

placebo-controlled

lornoxicam

aspirin

lornoxicam

lornoxicam

aspirin 650

placebo

Lornoxicam

lornoxicam

aspirin

analgesic effects

analgesic efficacy

efficacy

reductions in pain

analgesic efficacy

well tolerated

adverse events

postoperative dental pain

One hundred and fifty

young adults

moderate to severe pain


Teriparatide improves early callus formation in distal radial fractures . BACKGROUND Teriparatide ( parathyreoid hormone ; PTH 1-34 ) increases skeletal mass in humans and improves fracture healing in animals . A recent randomized multicenter trial of nonoperated distal radial fractures showed a moderate shortening of the time to restoration of cortical continuity by treatment with 20 microg ( low-dose ) teriparatide per day , but not with 40 microg ( high-dose ) . As radiographic cortical continuity appears late in the healing process , perhaps too late for clinical relevance , we studied the qualitative appearance of the callus 5 weeks after fracture . METHODS One third of the patients of the international trial were treated at Linköping University Hospital . The multicenter trial did not evaluate early callus formation . We therefore made a blinded qualitative scoring of the callus at 5 weeks in our 27 patients . Callus formation was arbitrarily classified as rich , intermediate , or poor . RESULTS 9 patients were classified as rich ( none had received placebo , 3 low-dose teriparatide , and 6 high-dose teriparatide ) . 9 patients were classified as intermediate ( 1 had received placebo , 5 low-dose , and 3 high-dose ) . 9 patients were classified as poor ( 7 had received placebo , 1 low-dose , and 1 high-dose ) ( p < 0.001 ) . INTERPRETATION This is a post hoc subgroup analysis of an outcome variable , which was not in the official protocol . The results must therefore be interpreted with caution . However , in combination with the results of the larger trial , the data suggest that radiographic quality at an early time point might be a sensitive variable , perhaps better than time to cortical continuity . Moreover , teriparatide appeared to improve early callus formation in distal radial fractures .

20 microg ( low-dose ) teriparatide

not with 40 microg ( high-dose )

early callus formation

distal radial fractures .

nonoperated distal radial fractures


[ Hepatoprotective activity of remaxol in patients with chronic hepatic disorders ] . This milticentre randomized clinical study of the efficiency of remaxol infusion solution ( hepatoprotective medicine for chronic liver dysfunction ) included 494 patients with chronic hepatitis B and C. 294 of them staying in 7 clinics were given remaxol and 200 ones received placebo . Randomization was achieved by the envelope method . A detailed description of clinical and laboratory characteristics of the diseases is presented . Effects of remaxol vs placebo on the functional activity of affected liver are discussed . Results of laboratory and clinical analysis indicate that mechanism of remaxol action is based on hepatoprotective , antioxidative , and anticholestatic activities of the drug .

remaxol

remaxol infusion solution

remaxol

placebo

remaxol

placebo

remaxol

Hepatoprotective activity

efficiency

functional activity

chronic hepatic disorders

494 patients

chronic hepatitis B and C.

7 clinics


Effects of 10 Hz repetitive transcranial magnetic stimulation ( rTMS ) on clinical global impression in chronic schizophrenia . UNLABELLED We conducted a randomized , sham-controlled repetitive transcranial magnetic stimulation ( rTMS ) study in chronic schizophrenia in-patients ( n=35 ) to evaluate the therapeutic efficacy of 10 Hz stimulation . Patients , who were on stable antipsychotic treatment , were randomly assigned to the active or sham condition . In the active rTMS group , ten sessions with a total of 10,000 stimuli were applied over the left dorsolateral prefrontal cortex at 110 % of motor threshold . The sham group received corresponding sham stimulation . Clinical improvement was measured by the Clinical Global Impression scale ( primary outcome measure ) , the Global Assessment of Functioning Scale ( GAF ) and the Positive and Negative Symptom Scale ( PANSS ; secondary outcome measures ) . Between-group comparisons revealed no significant differences in clinical outcome variables . Only a subgroup of patients with pronounced negative symptoms developed some clinical improvement as indicated by significant changes in the GAF-scale . Besides there is some evidence for a more favourable clinical outcome within this subgroup after rTMS in the CGI-S and PANSS negative scale , too . In line with earlier investigations , our results suggest a moderate - potentially clinically relevant - treatment effect of prefrontal 10 Hz rTMS stimulation in chronic patients . However , in our study this beneficial effect was restricted to subjects with pronounced negative symptoms . CLINICAL TRIAL REGISTRATION INFORMATION ClinicalTrial.gov Identifier : NCT00169689 , http : //www.clinicaltrials.gov .

10 Hz

rTMS

sham stimulation

rTMS

prefrontal 10 Hz rTMS

Between-group comparisons revealed

there is some evidence for a

more favourable clinical outcome

results suggest a

of

prefrontal 10 Hz rTMS stimulation

in chronic patients

chronic schizophrenia

chronic schizophrenia

stable antipsychotic treatment

chronic


Personalized smoking cessation : interactions between nicotine dose , dependence and quit-success genotype score . Improving and targeting nicotine replacement therapy ( NRT ) are cost-effective strategies for reducing adverse health consequences for smokers . Treatment studies document the efficacy of precessation NRT and support important roles for level of nicotine dependence and precessation smoking reduction in successful quitting . However , prior work has not identified the optimal precessation dose or means for personalizing NRT . Genome-wide association has identified groups of genomic markers associated with successful quitting , allowing us to develop a v1.0 " quit-success " genotype score . We now report influences of v1.0 quit-success genotype score , level of dependence and precessation smoking reduction in a smoking cessation trial that examined effects of 21 versus 42 mg/24 h precessation NRT . Four hundred seventy-nine smokers were randomized to 21 or 42 mg NRT , initiated 2 wks prior to target quit dates . We monitored self-reported abstinence and end-expired air carbon monoxide ( CO ) . Genotyping used Affymetrix arrays ( Santa Clara , CA , USA ) . The primary outcome was 10-wk continuous smoking abstinence . NRT dose , level of nicotine dependence and genotype scores displayed significant interactive effects on successful quitting . Successful abstinence also was predicted by CO reductions during precessation NRT . These results document ways in which smoking cessation strategies can be personalized based on levels of nicotine dependence , genotype scores and CO monitoring . These assessments , taken together , can help match most smokers with optimal NRT doses and help rapidly identify some who may be better treated using other methods .

nicotine replacement therapy ( NRT )

NRT

NRT

NRT

NRT

NRT

NRT

v1.0 quit-success genotype score

self-reported abstinence

end-expired air carbon monoxide ( CO )

Affymetrix arrays

10-wk continuous smoking abstinence

NRT dose

level of nicotine dependence

significant interactive effects

Successful abstinence

CO reductions

levels of nicotine dependence

genotype scores and CO monitoring


Weight-adjusted dalteparin for prevention of vascular thromboembolism in advanced pancreatic cancer patients decreases serum tissue factor and serum-mediated induction of cancer cell invasion . The aim of the present study was to assess the role of tissue factor and serum-induced cell invasion in patients with advanced pancreatic cancer ( APC ) . A cohort of 39 patients with APC , without thrombosis , receiving chemotherapy , were entered in a randomized controlled trial ( ISRCTN = 76464767 ) of thromboprevention with weight-adjusted dalteparin ( WAD ) . A total of 19 patients received WAD , the remaining 20 acting as a control group . Serum from baseline and week 8 was analysed for circulating-tissue factor antigen using ELISA . Circulating-tissue factor antigen rose from 324 pg/ml , [ interquartile range ( IQR ) 282-347 pg/ml ] to 356 pg/ml , ( IQR 319-431 pg/ml ) in controls ( C ) , and decreased in the dalteparin-treated group ( D ) from 336 pg/ml ( IQR 281-346 pg/ml ) to 303 pg/ml ( IQR 274-339 pg/ml ) . The difference in median percentage change between D and C was statistically significant [ -4.0 ( D ) vs. 4.7 ( C ) ; P = 0.005 , n = 39 ] . Serum-induced cellular invasion of MIA-Paca-2 cells in response to patient serum was studied using a Boyden chamber assay in 30 patients ( 14 WAD and 16 C ) . The median percentage change between C and D was significant [ +54.9 ( C ) vs. -21.9 ( D ) P = 0.025 , n = 30 ] . There was a weak correlation between BB-tissue factor reduction and cellular invasion reduction ( Spearman ) [ 0.384 ( P = 0.037 , n = 30 ) ] . APC patients treated with WAD have lower tissue factor antigen levels and attenuated induction of cellular invasion in their blood . These assays may provide useful markers to guide appropriate dalteparin ( and other low-molecular weight heparin ) dosing schedules to optimize anticancer effects of dalteparin in APC .

dalteparin

chemotherapy

WAD

control group

vascular thromboembolism

advanced pancreatic cancer

Circulating-tissue factor antigen

median percentage change

anticancer effects

advanced pancreatic cancer patients

39 patients

thrombosis , receiving chemotherapy

APC patients treated