@ patients in the docetaxel plus nintedanib group and @ in the docetaxel plus placebo group died of adverse events possibly unrelated to disease progression ; the most common of these events were sepsis ( five with docetaxel plus nintedanib vs one with docetaxel plus placebo ) , pneumonia ( two vs seven ) , respiratory failure ( four vs none ) , and pulmonary embolism ( none vs three ) .


Nintedanib in combination with docetaxel is an effective second-line option for patients with advanced NSCLC previously treated with one line of platinum-based therapy , especially for patients with adenocarcinoma .


To investigate the effects of cell therapy on myocardial perfusion recovery after treatment of acute myocardial infarction ( MI ) with primary percutaneous coronary intervention ( PCI ) .


In this HEBE trial substudy , which was approved by the institutional review board ( trial registry number ISRCTN@ ) , the authors assessed the effects of intracoronary infusion with bone marrow-derived mononuclear cells ( BMMCs ) or peripheral blood-derived mononuclear cells ( PBMCs ) on myocardial perfusion recovery by using cardiac magnetic resonance ( MR ) imaging after revascularization .


In @ patients with acute MI treated with PCI , cardiac MR imaging was performed after obtaining informed consent-before randomization to BMMC , PBMC , or standard therapy ( control group ) - and repeated at @-month follow-up .


Cardiac MR imaging consisted of cine , rest first-pass perfusion , and late gadolinium enhancement imaging .


Perfusion was evaluated semiquantitatively with signal intensity-time curves by calculating the relative upslope ( percentage signal intensity change ) .


The relative upslope was calculated for the MI core , adjacent border zone , and remote myocardium .


Perfusion differences among treatment groups or between baseline and follow-up were assessed with the Wilcoxon signed rank or Mann-Whitney U test .


At baseline , myocardial perfusion differed between the MI core ( median , @ % ; interquartile range -LSB- IQR -RSB- , @ % -@ % ) , border zone ( median , @ % ; IQR , @ % -@ % ) , and remote myocardium ( median , @ % ; IQR , @ % -@ % ) ( P < @ for all ) , with equal distribution among treatment groups .


These interregional differences persisted at follow-up ( P < @ for all ) .


No difference in perfusion recovery was found between the three treatment groups for any region .


After revascularization of ST-elevation MI , cell therapy does not augment the recovery of resting perfusion in either the MI core or border zone .


The prevalence of Chronic Heart Failure ( CHF ) in Spain is very high .


It is the main cause of many hospital admissions and it is associated with high mortality rates .


Its management in Primary Care is not always adequate .


Our objective was to evaluate whether an educational intervention in general practitioners would improve the health care of their patients with chronic heart failure .


Prospective , randomised , and controlled study .


A structured formative course was given to the intervention group ( IG ) of practitioners .


A year later changes were compared with a control group ( CG ) .


The settings were two Primary Care Centres .


One of them was in a rural setting , and the other one with a mixture of rural and urban populations .


The study included @ patients diagnosed with CHF , with a mean age of @ years , and they were assigned to @ practitioners ( Total population : @ , @ ) We evaluated the quality of medical history , clinical examination , laboratory tests and treatment .


At the end of the study there were marked differences between both groups .


In the IG , the Medical History improved @ points ( @ % CI : @ to @ ) , P = @ .


The Clinical Examination improved @ points ( @ % CI : @ to @ ) , P > @ and the Laboratory Tests , @ points ( @ % CI : -@ to @ ) , P = @ ; The Overall Difference was @ points ( @ % Cl : @ to @ ) , P > @ .


There were slight improvements in Treatment .


The intervention promoted from our own work settings achieved a general improvement in the care of patients with heart failure .


To compare the effects of hyperbaric and isobaric bupivacaine spinal anesthesia on hemodynamics and heart rate variability ( HRV ) in nonobstetric surgery .


Sixty patients were randomly allocated to @ groups .


Group I ( n = @ ) received @ mg ( @ mL ) of hyperbaric bupivacaine and Group II ( n = @ ) received @ mg ( @ mL ) of isobaric bupivacaine for spinal anesthesia .


Hemodynamic parameters were recorded before and after spinal anesthesia over @ min .


Analyses of HRV were performed on the day of surgery , after volume loading , and @ min after spinal injection .


Low frequency ( LF ) values , high frequency ( HF ) values , and LF/HF ratios were recorded .


The incidences of hypotension and alterations of HRV parameters in both groups were investigated .


The incidence ofhypotension was @ % and @ % in Groups I and II , respectively .


There were no significant differences in the LF and HF values and LF/HF ratios between groups .


In Group I , LF/HF ratios were significantly lower and HF values were significantly higher at @ min after spinal anesthesia , in comparison to the baseline value ( P < @ ) .


Hyperbaric bupivacaine caused a significantly greater decrease in LF/HF ratios and a significantly greater increase in HF values .


An association between relatively deep anesthesia , as guided by the bispectral index ( BIS ) , and increased postoperative mortality has been demonstrated in @ of @ published observational studies , but association does not necessarily mean causality .


Small clinical trials of anesthetic depth have demonstrated increased delirium and postoperative cognitive dysfunction in patients who were relatively deeply anesthetized , but have been inadequately powered to study mortality .


A large-scale randomized study is required to determine whether causality exists .


The primary hypothesis of our study is that `` light '' anesthesia , defined as a BIS target of @ , will reduce all-cause mortality within @ year of surgery in comparison with `` deep '' anesthesia , defined as a BIS target of @ , in patients aged @ years presenting for major surgery under general anesthesia .


The trial is an international multicenter , randomized , parallel-group , double-blind ( patients and investigators ) prospective , intention-to-treat , safety and efficacy study .


The relative reduction in mortality in the light anesthesia group is expected to be @ % , giving an absolute risk reduction from @ % to @ % .


Power analysis using a = @ and b = @ indicates that @ patients are required in each group .


The study is underway , and @ patients have been recruited in @ centers in @ countries .


It is anticipated that the study will be completed in @ years .


This randomized controlled trial should definitively answer the question of whether titrating anesthetic depth makes a difference to patient outcome in a vulnerable patient group .


The benefits of narrow band imaging ( NBI ) on enhancing colorectal adenoma detection remain questionable .


We tested whether the new generation of NBI ( @-NBI ) , which is twice as bright as the previous version , would improve adenoma detection when compared with high-definition white light ( HD-WL ) colonoscopy .


It was a randomized controlled trial with tandem colonoscopy .


We recruited patients who underwent colonoscopy for symptoms , screening , or surveillance .


Patients were randomized for the use of either @-NBI or HD-WL on withdrawal .


Tandem colonoscopy was performed by using the same assigned colonoscope and withdrawal method .


Lesions detected on first-pass and second-pass examination were used for adenoma detection and miss rates , respectively .


The primary outcomes were adenoma and polyp detection rates .


A total of @ patients were randomized to undergo either @-NBI or HD-WL colonoscopy .


Both the adenoma and polyp detection rates were significantly higher in the @-NBI group compared with the HD-WL group ( adenoma : @ % vs. @ % , P = @ ; polyps : @ % vs. @ % , P = @ ) .


The mean number of polyps detected per patient was higher in the @-NBI group ( @ % vs. @ , P = @ ) .


There was no significant difference in the adenoma miss rates between the two groups ( @ % vs. @ % ) .


Multivariate analysis showed that the use of @-NBI ( odds ratio ( OR ) @ ; @ % confidence interval ( CI ) @-@ @ ) , withdrawal time ( OR @ ; CI @-@ @ ) , patient 's age ( OR @ ; CI @-@ @ ) , and male gender ( OR @ ; CI @-@ @ ) were associated with adenoma detection .


@-NBI colonoscopy was superior to the conventional HD-WL in detecting colorectal adenomas or polyps , but there was no significant difference in adenoma miss rates .


To compare the success rates of probing versus bicanalicular silastic intubation as the primary treatment for congenital nasolacrimal duct obstruction ( CNLDO ) in children @year old .


Prospective , randomised , comparison .


Participants were randomised to undergo probing or bicanalicular silastic intubation .


In bilateral cases , the right eye was used for analysis .


The procedure was considered successful when all preoperative manifestations disappeared with normal dye disappearance test and a positive Jones primary dye test at least @months postoperatively .


Secondary outcomes were risk factors for failure .


Outcomes were compared between treatments with p < @ indicating statistical significance .


@ eyes of @ children between @ and @years old with CNLDO who had not undergone previous surgical treatment were included in the study .


@ eyes underwent probing with a @ % success rate and @ eyes that underwent bicanalicular silastic intubation had a @ % success rate ( p = @ ) .


For simple CNLDO , there was a @ % ( @/@ ) success rate with probing and a @ % ( @/@ ) success rate with bicanalicular silastic intubation ( p = @ ) .


In complex CNLDO , there was a @ % ( @/@ ; p = < @ ) success rate with probing and an @ % ( @/@ ; p = @ ) success rate with silastic intubation ( p = @ ) .


Age was not a risk factor for failure in either procedure .


Probing for simple CNLDO in young children is adequate .


Bicanalicular silastic intubation seems to have a role in achieving successful outcomes in complex CNLDO .


Despite recommendations against systematic screening for prostate cancer , @ % of patients still request prostate-specific antigen testing .


To assess the impact of a decision aid on patients ' intention to undergo prostate cancer screening .


Randomised controlled trial with two-arm parallel groups in @ general practices in urban and rural areas in France .


Males aged @-@ years were randomised to receive either the decision aid ( intervention group ) or usual care ( control group ) .


The primary outcome was the proportion of patients ' intending to undergo prostate cancer screening , assessed immediately after reading the decision aid .


The reasons underlying their choice were elicited and the proportion of patients citing each reason to undergo , or not undergo , prostate cancer screening were compared between the two arms .


A total of @ patients were randomised ( @ in the intervention arm ) from November @ to February @ .


The proportion of patients who intended to be tested for prostate cancer in the intervention arm ( @ patients -LSB- @ % -RSB- ) was significantly reduced compared with the control arm ( @ patients -LSB- @ % -RSB- ) ( difference @ % , @ % confidence interval -LSB- CI -RSB- = @ to @ , P < @ ) .


In the intervention group , a lower proportion of individuals expressed that cancer screening would protect them from the disease , compared with the control group ( P < @ ) , while a greater proportion of individuals stated that prostate cancer screening would not benefit their health ( P < @ ) and may involve procedures with harmful side effects ( P = @ ) .


The decision aid improved participants ' informed decision making and reduced their intent to undergo prostate cancer screening .


To examine if supported employment ( SE ) remains more effective than treatment as usual ( TAU ) in returning veterans to competitive employment after spinal cord injury ( SCI ) at @-year follow-up .


Prospective , randomized , controlled , multisite trial of SE versus TAU with @ months of follow-up .


SCI centers .


Subjects ( N = @ ) were enrolled and completed baseline interviews .


At interventional sites , subjects were randomized to SE ( n = @ ) or TAU ( n = @ ) .


At observational sites , @ subjects were enrolled in a nonrandomized TAU condition .


The intervention was a SE program called the SCI Vocational Integration Program , which followed the principles of the individual placement and support model of SE for persons with mental illness .


Competitive employment in the community within @ years .


For the entire @-year follow-up period , SE subjects were significantly more likely to achieve employment ( @ % ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) than either the TAU subjects at the intervention sites ( @ % ; @ % CI , @-@ @ ; P < @ ) or the TAU subjects at the observational sites ( @ % ; @ % CI , @-@ @ ; P < @ ) .


Most subjects who obtained competitive employment did so in year @ , and the average time to first employment was about @ weeks .


SE was better than usual practices in improving employment outcomes for veterans with SCI across a @-year follow-up period .


Although SE continued to be superior to traditional practices over the entire study , the first year of participation in SE may represent a critical window for achieving employment after SCI .


Our objective was to evaluate the effectiveness of hands-on training at a bedside ultrasound ( US ) symposium ( `` Ultrafest '' ) to improve both clinical knowledge and image acquisition skills of medical students .


Primary outcome measure was improvement in multiple choice questions on pulmonary or Focused Assessment with Sonography in Trauma ( FAST ) US knowledge .


Secondary outcome was improvement in image acquisition for either pulmonary or FAST .


Prospective cohort study of @ volunteers at `` Ultrafest , '' a free symposium where students received five contact training hours .


Students were evaluated before and after training for proficiency in either pulmonary US or FAST .


Proficiency was assessed by clinical knowledge through written multiple-choice exam , and clinical skills through accuracy of image acquisition .


We used paired sample t-tests with students as their own controls .


Pulmonary knowledge scores increased by a mean of @ points ( @ % CI -LSB- @-@ @ -RSB- , p < @ ) , from @ to a posttest average of @ / @ possible points .


The FAST knowledge scores increased by a mean of @ points ( @ % CI -LSB- @-@ @ -RSB- p < @ ) , from @ to a posttest average of @ / @ .


We analyzed clinical skills data on @ students .


The mean score was @ pretest and @ posttest of @ possible points .


Mean improvement was @ points ( p < @ ) overall , @ ( p = @ ) for FAST , and @ ( p = @ ) for the pulmonary US exam .


This study suggests that a symposium on US can improve clinical knowledge , but is limited in achieving image acquisition for pulmonary and FAST US assessments .


US training external to official medical school curriculum may augment students ' education .


To evaluate the efficacy and safety of ramucirumab ( IMC-@B ; LY@ ) , a fully human monoclonal antibody targeting the vascular endothelial growth factor receptor-@ , alone and in combination with dacarbazine in chemotherapy-nave patients with metastatic melanoma ( MM ) .


Eligible patients received ramucirumab ( @mg/kg ) + dacarbazine ( @ mg/m ( @ ) ) ( Arm A ) or ramucirumab only ( @mg/kg ) ( Arm B ) every @ weeks .


The primary end-point was progression-free survival ( PFS ) ; secondary end-points included overall survival ( OS ) , overall response and safety .


Of @ randomised patients , @ received study treatment ( Arm A , N = @ ; Arm B , N = @ ) .


Baseline characteristics were similar in both arms .


Median PFS was @ months ( Arm A ) and @ months ( Arm B ) ; median @-month PFS rates were @ % and @ % and @-month PFS rates were @ % and @ % , respectively .


In Arm A , @ ( @ % ) patients had partial response ( PR ) and @ ( @ % ) , stable disease ( SD ) ; PR and SD in Arm B were @ ( @ % ) and @ ( @ % ) , respectively .


Median OS was @ months in Arm A and @ months in Arm B. Patients in both arms tolerated the treatment with limited Grade @/@ toxicities .


Ramucirumab alone or in combination with dacarbazine was associated with an acceptable safety profile in patients with MM .


Although the study was not powered for comparison between treatment arms , PFS appeared greater with combination therapy .


Sustained disease control was observed on both study arm .


Many programs emphasize subsequent pregnancy prevention and high school graduation among teenage mothers ; however , less is known about their ability to increase financial earnings from employment opportunities while concurrently enrolled in school .


This study evaluates factors influencing employment status among teenage mothers after enrolling in a community-based randomized intervention .


Project Mothers and Schools ( PMAS ) initiative participants were surveyed at baseline and @ months after enrollment .


The @ control group participants received homebound education and family case management , whereas the @ intervention group participants received these basic-level services as well as group parenting time , life skills , and leadership training .


A generalized estimating equation was used to identify statistically significant changes associated with the intervention .


Participants were significantly more likely to receive money from their jobs at postintervention relative to baseline ( OR = @ , p = @ ) ; however , this change was not statistically significant when comparing the control group to the intervention group .


At postintervention , those who received money from parents were significantly less likely to receive money from their job ( OR = @ , p = @ ) .


While PMAS benefited participants in terms of employment , the role of parental support requires additional investigation to determine its influence on teenage mothers ' ability to achieve financial independence .


To evaluate the effect of two postnatal professional support interventions on the duration of any and exclusive breastfeeding .


Multicentre , three-arm , cluster randomised controlled trial .


A cohort of @ primiparous breastfeeding mothers with uncomplicated , full-term pregnancies .


The three study interventions were : ( @ ) standard postnatal maternity care ; ( @ ) standard care plus three in-hospital professional breastfeeding support sessions , of @-@minutes in duration ; or ( @ ) standard care plus weekly post-discharge breastfeeding telephone support , of @-@minutes in duration , for @weeks .


The interventions were delivered by four trained research nurses , who were either highly experienced registered midwives or certified lactation consultants .


Prevalence of any and exclusive breastfeeding at @ , @ , and @months postpartum .


Rates of any and exclusive breastfeeding were higher among participants in the two intervention groups at all follow-up points , when compared with those who received standard care .


Participants receiving telephone support were significantly more likely to continue any breastfeeding at @month ( @ versus @ % ; odds ratio , OR@ @ , @ % confidence interval , @ % CI @-@ @ ) and at @months ( @ versus @ % ; OR@ @ , @ % CI @-@ @ ) , and to be exclusively breastfeeding at @month ( @ versus @ % ; OR@ @ , @ % CI @-@ @ ) .


Participants in the in-hospital support group were also more likely to be breastfeeding at all time points , but the effect was not statistically significant .


Professional breastfeeding telephone support provided early in the postnatal period , and continued for the first month postpartum , improves breastfeeding duration among first-time mothers .


It is also possible that it was the continuing nature of the support that increased the effectiveness of the intervention , rather than the delivery of the support by telephone specifically .


Alcohol misuse among youth is a major public health concern and numbers of adolescents admitted to the emergency department for acute alcoholic intoxication in Germany are recently growing .


The emergency setting offers an opportunity to reach at-risk alcohol consuming adolescents and provide brief interventions in a potential `` teachable moment '' .


However , studies on brief interventions targeting adolescents in emergency care are scarce and little is known about their effectiveness when delivered immediately following hospitalization for acute alcohol intoxication .


In this protocol we present the HaLT-Hamburg trial evaluating a brief motivational intervention for adolescents treated in the emergency department after an episode of acute alcoholic intoxication .


The trial design is a parallel two-arm cluster randomized-controlled trial with follow-up assessment after @ and @ months .


N = @ participants aged @ years and younger will be recruited Fridays to Sundays in @ pediatric clinics over a period of @ months .


Intervention condition is a manual-based brief motivational intervention with a telephone booster after @ weeks and a manual-guided intervention for caregivers which will be compared to treatment as usual .


Primary outcomes are reduction in binge drinking episodes , quantity of alcohol use on a typical drinking day and alcohol-related problems .


Secondary outcome is further treatment seeking .


Linear mixed models adjusted for baseline differences will be conducted according to intention-to-treat ( ITT ) and completers ( per-protocol ) principles to examine intervention effects .


We also examine quantitative and qualitative process data on feasibility , intervention delivery , implementation and receipt from intervention providers , receivers and regular emergency department staff .


The study has a number of strengths .


First , a rigorous evaluation of HaLT-Hamburg is timely because variations of the HaLT project are widely used in Germany .


Second , prior research has not targeted adolescents in the presumed teachable moment following acute alcohol intoxication .


Third , we included a comprehensive process evaluation to raise external validity .


Fourth , the study involved important stakeholders from the start to set up organizational structures for implementation and maintaining project impact .


Paclitaxel drug-eluting balloons ( pDEB ) could be an attractive option to minimise side branch ( SB ) restenosis in bifurcated coronary lesions .


We compared angiographic and clinical outcomes with pDEB plus bare metal stent ( BMS ) versus drug-eluting stents ( DES ) in de novo bifurcated lesions .


This multicentre randomised trial included @ patients .


Sequential main branch ( MB ) / SB dilatation with pDEB , with provisional T-stenting with BMS in the MB was performed in the pDEB group , and with everolimus DES in the DES group .


The primary endpoint was late lumen loss ( LLL ) at nine months .


The secondary endpoint was the incidence of major adverse cardiac events ( MACE : death , myocardial infarction , or target lesion revascularisation ) .


In-segment MB LLL was @ mm in the pDEB group , and @ mm in the DES group ( p = @ ) ; mean difference was @ mm ( upper limit one-sided @ % CI : @ mm ; p = @ ; non-inferiority test ) .


LLL in SB was -@ mm in the pDEB group and -@ mm in the DES group ( p = @ ) .


MACE and TLR were higher in the pDEB group ( @ % vs. @ % ; p = @ , and @ % vs. @ % ; p = @ ) , due to higher MB restenosis ( @ % vs. @ % ; p = @ ) .


pDEB bifurcation pretreatment with BMS implantation in MB showed greater LLL ( ns ) and increased incidence of MACE compared to everolimus DES .


Both strategies showed similar results in the SB .


Women who deliver preterm infants are at a much greater risk for repeating a preterm birth ( PTB ) , compared to women without a history of PTB .


However , little is known about the prevalence of the risk factors which account for this markedly increased risk .


Moreover , little or nothing is known about the feasibility of providing treatments and services to these women , outside of the context of prenatal care , during the inter-conception period , which provides the best opportunity for successful risk-reduction interventions .


The Philadelphia Collaborative Preterm Prevention Project ( PCPPP ) , a large randomized control trial designed to identify and reduce six major risk factors for a repeat preterm birth among women immediately following the delivering of a preterm infant .


For the women assigned to the PCPPP treatment group , we calculated the prevalence of the six risk factors in question , the percentages of women who agreed to receive high quality risk-appropriate treatments or services , and the of rates of participation among those who were offered and eligible for these treatments or services .


Urogenital tract infections were identified in @ % of the women , while @ % were found to have periodontal disease .


More than @ % were active smokers , and @ % were assessed with clinical depression .


Low literacy , and housing instability were identified in , @ and @ % of the study sample , respectively .


Among women eligible for intervention , the percentages who accepted and at least minimally participated in treatment ranged from a low of @ % for smoking , to a high of @ % for urogenital tract infection .


Most PCPPP enrollees ( @ % ) had three or more major risk factors .


Participation rates associated with the PCPPP treatments or services varied markedly , and were quite low in some cases , despite considerable efforts to reduce the barriers to receiving care .


The efficacy of individual level risk-reduction efforts designed to prevent preterm/repeat preterm in the pre - or inter-conception period may be limited if participation rates associated with interventions to reduce major risk factors for PTB are low .


Achieving adequate participation may require identifying , better understanding , and eliminating barriers to access , beyond those associated with cost , transportation , childcare , and service location or hours of operation .


Myoelectric prostheses use electromyographic ( EMG ) signals to control movement of prosthetic joints .


Clinically available myoelectric control strategies do not allow simultaneous movement of multiple degrees of freedom ( DOFs ) ; however , the use of implantable devices that record intramuscular EMG signals could overcome this constraint .


The objective of this study was to evaluate the real-time simultaneous control of three DOFs ( wrist rotation , wrist flexion/extension , and hand open/close ) using intramuscular EMG .


We evaluated task performance of five able-bodied subjects in a virtual environment using two control strategies with fine-wire EMG : ( i ) parallel dual-site differential control , which enabled simultaneous control of three DOFs and ( ii ) pattern recognition control , which required sequential control of DOFs .


Over the course of the experiment , subjects using parallel dual-site control demonstrated increased use of simultaneous control and improved performance in a Fitts ' Law test .


By the end of the experiment , performance using parallel dual-site control was significantly better ( up to a @ % increase in throughput ) than when using sequential pattern recognition control for tasks requiring multiple DOFs .


The learning trends with parallel dual-site control suggested that further improvements in performance metrics were possible .


Subjects occasionally experienced difficulty in performing isolated single-DOF movements with parallel dual-site control but were able to accomplish related Fitts ' Law tasks with high levels of path efficiency .


These results suggest that intramuscular EMG , used in a parallel dual-site configuration , can provide simultaneous control of a multi-DOF prosthetic wrist and hand and may outperform current methods that enforce sequential control .


To simultaneously examine the effects of acute exercise intensity and free-living physical activity and sedentary behavior on cognitive function in young , healthy adults .


Using a counterbalanced , crossover , randomized controlled design , @ young adults ( mean age , @ years ) completed various cognitive assessments with and without an acute bout of exercise preceding the assessment .


Participants were randomized into @ of @ groups to complete a @-minute bout of acute exercise : control ( no exercise ) , light intensity ( @ % -@ % of predicted maximum heart rate -LSB- HR ( max ) -RSB- ) , moderate intensity ( @ % -@ % of predicted HR ( max ) ) , or vigorous intensity ( @ % -@ % of predicted HR ( max ) ) .


Subjectively and objectively determined ( accelerometry ) physical activity and sedentary behavior were assessed to examine the association between these free-living behaviors and cognitive function .


The study duration was August @ , @ , to September @ , @ .


Concentration-related cognition ( mean SD Feature Match test score ) was significantly higher after a @-minute acute bout of moderate-intensity exercise ( @ ) compared with cognitive assessment without exercise ( @ ; P = @ ) .


Furthermore , questionnaire-determined sedentary behavior was inversely associated with visual attention and task switching ( Trail Making Test A score ) ( = -@ ; P = @ ) .


Last , estimated cardiorespiratory fitness ( volume of maximum oxygen consumption ) was positively associated with reasoning-related cognitive function ( Odd One Out test score ) ( = @ ; P = @ ) ; when adding metabolic equivalent of task minutes per week to this model , the results were not significant ( = @ ; P = @ ) .


These findings provide some support for acute moderate-intensity exercise , sedentary behavior , and cardiorespiratory fitness being associated with executive functioning-related cognitive function in young , healthy adults .


The purpose of this study was to assess the efficacy and safety of edivoxetine ( LY@ ) , a selective norepinephrine reuptake inhibitor , in pediatric patients with attention-deficit/hyperactivity disorder ( ADHD ) .


A fixed-dose , randomized , double-blind , @ week study was conducted in patients @-@ years of age , who were randomized by two strata : @ ) Patients with prior stimulant use randomized to placebo , edivoxetine @ mg/kg/day , @ mg/kg/day , or @ mg/kg/day arms in a @:@:@:@ ratio ; @ ) Stimulant-nave patients randomized to placebo , edivoxetine @ mg/kg/day , @ mg/kg/day , @ mg/kg/day , or osmotic-release oral system methylphenidate ( OROS MPH ) ( @-@mg / day based on body weight ) arms in a @:@:@:@:@ ratio .


The primary efficacy measure was baseline-to-week @ change of ADHD Rating Scale ( ADHD-RS ) total score for edivoxetine @ mg/kg/day and @ mg/kg/day .


A total of @ patients were randomized to placebo ( n = @ ) ; edivoxetine @ mg/kg/day ( n = @ ) , @ mg/kg/day ( n = @ ) , or @ mg/kg/day ( n = @ ) ; or OROS MPH ( n = @ ) .


In the stimulant-nave stratum , the positive control , OROS MPH , was significantly superior to placebo in mean ADHD-RS total score change at end-point ( -@ , p = @ ) .


The edivoxetine @ mg/kg/day and @ mg/kg/day arms had statistically significantly greater improvement than the placebo arm in mean ADHD-RS total score change at end-point ( placebo -@ ; edivoxetine @ mg/kg/day -@ , p < @ ; edivoxetine @ mg/kg/day -@ , p < @ ) and Clinical Global Impressions-Improvement score ( placebo @ ; edivoxetine @ mg/kg/day @ , p = @ ; edivoxetine @ mg/kg/day @ , p = @ ; edivoxetine @ mg/kg/day @ , p = @ ) .


In the overall efficacy-analyses data set ( n = @ ) , the effect size estimates for edivoxetine doses @ mg/kg/day , @ mg/kg/day and @ mg/kg/day at the week @ time point were @ , @ , and @ , respectively ( for the stimulant-nave stratum , the effect size estimate for OROS MPH was @ ) .


Compared with placebo , edivoxetine treatment was associated with statistically significant increases in blood pressure and pulse ( p < @ ) , and a smaller increase or slight decrease in weight .


Edivoxetine at doses of @ mg/kg/day and @ mg/kg/day demonstrated efficacy in ADHD treatment , despite the presence of a sizeable placebo response .


No unexpected adverse events were identified .


Clinical Trial Registry identifier : NCT@ .


To evaluate the relationship between number of metabolic syndrome ( MetS ) - like components and prostate cancer diagnosis in a group of men where nearly all biopsies were taken independent of prostate-specific antigen ( PSA ) level , thus minimising any confounding from how the various MetS-like components may influence PSA levels .


We analysed data from @ men in the Reduction by Dutasteride of Prostate Cancer Events ( REDUCE ) study with at least one on-study biopsy .


REDUCE compared dutasteride vs placebo on prostate cancer risk among men with an elevated PSA level and negative pre-study biopsy and included two on-study biopsies regardless of PSA level at @ and @ years .


Available data for MetS-like components included data on diabetes , hypertension , hypercholesterolaemia , and body mass index .


The association between number of these MetS-like components and prostate cancer risk and low-grade ( Gleason sum < @ ) or high-grade ( Gleason sum > @ ) vs no prostate cancer was evaluated using logistic regression .


In all , @ men ( @ % ) had one MetS-like component , @ ( @ % ) had two , and @ ( @ % ) had three or four .


Men with more MetS-like components had lower PSA levels ( P = @ ) .


One vs no MetS-like components was protective for overall prostate cancer ( P = @ ) and low-grade prostate cancer ( P = @ ) .


Two ( P = @ ) or three to four ( P = @ ) MetS-like components were not significantly related to prostate cancer .


While one MetS-like component was unrelated to high-grade prostate cancer ( P = @ ) , two ( P = @ ) or three to four MetS-like components ( P = @ ) were associated with increased high-grade prostate cancer risk , although only the latter was significant .


When biopsies are largely PSA level independent , men with an initial elevated PSA level and a previous negative biopsy , and multiple MetS-like components were at an increased risk of high-grade prostate cancer , suggesting the link between MetS-like components and high-grade prostate cancer is unrelated to a lowered PSA level .


Qigong is highly favoured among Asian breast cancer survivors for enhancing health .


This study examined the hypothesis that quality of life ( QoL ) in the Qigong group is better than the placebo ( aerobic ) or usual care group .


A total of @ participants were randomly assigned to either the @-week Kuala Lumpur Qigong Trial or control groups in @-@ .


Measurement taken at baseline and post - intervention included QoL , distress and fatigue .


Analysis of covariance ( ANCOVA ) and Kruskal Wallis were used to examine for differences between groups in the measurements .


There were @ consenting participants in this @week trial .


The adherence rates were @ % for Qigong and @ % for the placebo group .


The Qigong group showed significant marginal improvement in Quality of life scores compared to placebo ( mean difference = @ unit ; p = @ ) , compared to usual care ( mean difference = @ unit ; p = @ ) on Functional Assessment Cancer Therapy-Breast measure .


There were no significant changes between the placebo and usual care groups in fatigue or distress at post intervention ( @-week ) .


Cancer survivors who participated in the Qigong intervention showed slightly better QOL .


Follow up studies are greatly needed to evaluate which subgroups may best benefit from Qigong .


With a steep rise of cancer survivors , there is an urgent need to explore and engage more cultural means of physical activity to fight side effects of treatment and for cancer control in developing countries .


Our goal was to evaluate the effect of breakfast size and composition on body weight , glycemic control , and metabolic markers in adults with type @ diabetes mellitus ( T@DM ) .


@ overweight/obese adults with T@DM were randomized to one of two isocaloric diabetic diets for @ months ; big breakfast ( BB ) , breakfast was rich in fat and protein and provided @ % of total daily energy or small breakfast ( SB ) , breakfast was rich in carbohydrates and provided @ % of total daily energy .


Although body weight was reduced similarly in both groups , the BB group showed greater HbA@c and systolic blood pressure reductions ( HbA@c : -@ % vs. -@ % , p = @ ; SBP -@ vs. -@ mmHg ; p = @ ) .


T@DM medication dose was reduced in a greater proportion of the BB participants ( @ % vs. @ % ; p = @ ) while in the SB , a greater proportion of participants had a dose increases ( @ % vs. @ % ; p = @ ) .


Hunger scores were lower in the BB group and greater improvements in fasting glucose were observed in the BB group .


A simple dietary manipulation enriching breakfast with energy as protein and fat appears to confer metabolic benefits and might be a useful alternative for the management of T@DM .


To evaluate the association between baseline comprehensive geriatric assessment ( CGA ) or the Groningen Frailty Indicator ( GFI ) and toxicity in elderly metastatic breast cancer ( MBC ) patients treated with first-line palliative chemotherapy .


MBC patients ( @ years ) were randomized between pegylated liposomal doxorubicine or capecitabine .


CGA included instrumental activities of daily living ( IADL ) , cognition using the mini-mental state examination ( MMSE ) , mood using the geriatric depression scale ( GDS ) , comorbidity using the Charlson index , polypharmacy and nutritional status using the body mass index .


Frailty on CGA was defined as one or more of the following : IADL@ , MMSE@ , GDS@ , BMI@ , @ medications or Charlson @ .


The cut-off for frailty on the GFI was @ .


Of the randomized @ patients ( median age @ years , range @-@ @ years ) , @ were evaluable for CGA ; @ ( @ % ) had one or more geriatric conditions .


Grade @-@ chemotherapy-related toxicity was experienced by @ % of patients without geriatric conditions compared to @ % of patients with two geriatric conditions and @ % of those with three or more ( p = @ ) .


Polypharmacy was the only individual factor significantly associated with toxicity ( p = @ ) .


GFI had a sensitivity of @ % and a specificity of @ % for frailty on CGA , and was not significantly associated with survival or toxicity .


In this study of elderly patients with MBC , the number of geriatric conditions correlated with grade @-@ chemotherapy-related toxicity .


Therefore , in elderly patients for whom chemotherapy is being considered , a CGA could be a useful addition to the decision-making process .


Hereditary haemochromatosis may result in severe organ damage which can be prevented by therapy .


We studied the possible advantages and disadvantages of erythrocytapheresis as compared with phlebotomy in patients with hereditary haemochromatosis .


In a prospective , randomised , open-label study , patients with hereditary haemochromatosis were randomised to bi-weekly apheresis or weekly whole blood phlebotomy .


Primary end-points were decrease in ferritin levels and transferrin saturation .


Secondary endpoints were decrease in haemoglobin levels , discomfort during the therapeutic procedure , costs and technicians ' working time .


Sixty-two patients were included .


Thirty patients were randomised to apheresis and @ to whole blood phlebotomy .


Initially , ferritin levels declined more rapidly in the apheresis group , and the difference became statistically highly significant at @ weeks ; however , time to normalisation of ferritin level was equal in the two groups .


We observed no significant differences in decline of transferrin saturation , haemoglobin levels or discomfort .


The mean cumulative technician time consumption until the ferritin level reached @ g/L was longer in the apheresis group , but the difference was not statistically significant .


The cumulative costs for materials until achievement of the desired ferritin levels were three-fold higher in the apheresis group .


Treatment of hereditary haemochromatosis with erythrocytapheresis instead of whole blood phlebotomy results in a more rapid initial decline in ferritin levels and a reduced number of procedures per patient , but not in earlier achievement of target ferritin level .


The frequency of discomfort was equally low with the two methods .


The costs and , probably , technician time consumption were higher in the apheresis group .


SMOFlipid @ % is intravenous lipid emulsion ( ILE ) containing long-chain triglycerides ( LCT ) , medium-chain triglycerides ( MCT ) , olive oil , and fish oil as a mixed emulsion containing - tocopherol .


The aim was to assess the efficacy of this new ILE in gastrointestinal surgery compared with MCT/LCT .


In this prospective study , @ patients were randomized to SMOFlipid @ % or MCT/LCT ( Lipovenoes @ % ) group .


Clinical and biochemistry data were collected .


Inflammatory markers ( CRP , IL-@ , IL-@ , TNF - , TGF-@ ) and oxidative stress ( ROS and superoxide ) were measured .


Thirty-five patients ( @ males and @ females ) with a mean age of @ years completed the study .


The patients ' demographic characteristics ( age , gender , height , body weight , and BMI ) were similar without significant differences between groups .


The increment of triglyceride on day @ from baseline was significantly lower in SMOFlipid group than in Lipovenoes MCT/LCT group .


Inflammatory markers , as well as superoxide radical and total oxygen radical were not different between groups .


Despite the comparable effect on inflammatory response , because of its well-balanced fatty acid pattern , relatively low n-@ : n-@ ratio , and high vitamin E content , SMOFlipid had a better triglyceride-lowering effect as compared with MCT/LCT in adult patients undergoing gastrointestinal surgery .


To explore therapeutic effect and action mechanism of regulating spleen-stomach needling on diabetic nephropathy ( DN ) .


Using multi-centric , randomized , controlled and blind principles , @ cases of DN were divided into an observation group and a control group according to random digital tab , @ cases in each one .


Based on regular treatment of diabetes , the regulating spleen-stomach needling was applied at Zhongwan ( CV @ ) , Quchi ( LI @ ) , Hegu ( LI @ ) and Xuehai ( SP @ ) , etc. in the observation group while Shenshu ( BL @ ) , Taixi ( KI @ ) , Sanyinjiao ( SP @ ) , Yanglingquan ( GB @ ) , etc. were selected in the control group by reference of Acupuncture and moxibustion .


The treatment was given twice a day , six days as a treatment session with interval of one day between sessions .


Totally six weeks were required .


Changes of clinical symptoms and signs , fast blood glucose ( FBG ) , urinary albumin excretion rate ( UAER ) , beta@-microglobulin ( beta@-MG ) , monocyte chemotactic protein-@ ( MCP-@ ) , lymphocyte membrane cholesterol , propanediol ( MDA ) , PCO , @-hydroxydeoxy guanosine ( @-OHdG ) , superoxide dismutase ( SOD ) , CD@ + , CD@ + , CD@ + , and CD@ + / CD@ + were observed before and after treatment in two groups .


As for improving clinical symptoms and signs , total effective rate was @ % ( @/@ ) in the observation group and @ % ( @/@ ) in the control group , which had statistical difference between two groups ( P < @ ) .


As for regulating glycometabolism -LSB- ( @ + / - @ ) mmol/L vs ( @ + / - @ ) mmol/L -RSB- , reducing UAER -LSB- ( @ + / - @ ) mg/@h vs ( @ + / - @ ) mg/@h -RSB- , restraining over-expression of MCP-@ -LSB- ( @ + / - @ ) pg/mL vs ( @ + / - @ ) pg/mL -RSB- , regulating level of oxidative stress , prohibiting oxidation of protein and adjusting quantity and activity of T lymphocyte subgroup , the observation group was superior to the control group ( P < @ , P < @ ) .


The regulating spleen-stomach needling is an effective method for treatment of DN , which cold improve glycometabolism disturbance-induced progressive kidney injury , recover glomerular filtration , reduce urinary albumin excretion rate , restrain overexpression of MCP-@ , adjust level of oxidative stress , prohibit oxidation of protein , increase protectiveness of membrane , adjust quantity and activity abnormity of T lymphocyte subgroup , leading to repairing lymphocyte damage and improving immune expression to delay kidney damage .


We investigated candidate genes associated with thiopurine metabolism and clinical response in childhood acute lymphoblastic leukemia .


We performed genome-wide SNP association studies of @-thioguanine and @-mercaptopurine cytotoxicity using lymphoblastoid cell lines .


We then genotyped the top SNPs associated with lymphoblastoid cell line cytotoxicity , together with tagSNPs for genes in the ` thiopurine pathway ' ( @ total SNPs ) , in DNA from @ Caucasian UK ALL@ patients .


Functional validation studies were performed by siRNA knockdown in cancer cell lines .


SNPs in the thiopurine pathway genes ABCC@ , ABCC@ , IMPDH@ , ITPA , SLC@A@ and XDH , and SNPs located within or near ATP@AP@ , FRMD@B , GNG@ , KCNMA@ and NME@ , were associated with clinical response and measures of thiopurine metabolism .


Functional validation showed shifts in cytotoxicity for these genes .


The clinical response to thiopurines may be regulated by variation in known thiopurine pathway genes and additional novel genes outside of the thiopurine pathway .


We performed a prospective , randomized , placebo-controlled study aimed to evaluate the efficacy and safety of a sedation protocol based on intranasal Ketamine and Midazolam ( INKM ) administered by a mucosal atomizer device in uncooperative children undergoing gastric aspirates for suspected tuberculosis .


evaluation of Modified Objective Pain Score ( MOPS ) reduction in children undergoing INKM compared to the placebo group .


evaluation of safety of INKM protocol , start time sedation effect , duration of sedation and evaluation of parents and doctors ' satisfaction about the procedure .


In the sedation group , @ children , mean age @ months , received intranasal Midazolam ( @ mg/kg ) and Ketamine ( @ mg/kg ) .


In the placebo group , @ children received normal saline solution twice in each nostril .


The child 's degree of sedation was scored using the MOPS .


A questionnaire was designed to evaluate the parents ' and doctors ' opinions on the procedures of both groups .


Fifty-seven gastric washings were performed in the sedation-group , while in the placebo-group we performed @ gastric aspirates .


The degree of sedation achieved by INMK enabled all procedures to be completed without additional drugs .


The mean duration of sedation was @ min .


Mean MOPS was @ ( range @-@ ) in the sedation-group , @ ( range @-@ ) in the placebo-group ( p < @ ) .


The questionnaire revealed high levels of satisfaction by both doctors and parents in the sedation-group compared to the placebo-group .


The only side effect registered was post-sedation agitation in @ procedures in the sedation group ( @ % ) .


Our experience suggests that atomized INKM makes gastric aspirates more acceptable and easy to perform in children .


To determine the optimal method for use of the Canine Brief Pain Inventory ( CBPI ) to quantitate responses of dogs with osteoarthritis to treatment with carprofen or placebo .


@ dogs with osteoarthritis .


Data were analyzed from @ studies with identical protocols in which owner-completed CBPIs were used .


Treatment for each dog was classified as a success or failure by comparing the pain severity score ( PSS ) and pain interference score ( PIS ) on day @ ( baseline ) with those on day @ .


Treatment success or failure was defined on the basis of various combinations of reduction in the @ scores when inclusion criteria were set as a PSS and PIS @ , @ , or @ at baseline .


Statistical analyses were performed to select the definition of treatment success that had the greatest statistical power to detect differences between carprofen and placebo treatments .


Defining treatment success as a reduction of @ in PSS and @ in PIS in each dog had consistently robust power .


Power was @ % in the population that included only dogs with baseline scores @ and @ % in the population that included only dogs with baseline scores @ .


The CBPI had robust statistical power to evaluate the treatment effect of carprofen in dogs with osteoarthritis when protocol success criteria were predefined as a reduction @ in PIS and @ in PSS .


Results indicated the CBPI can be used as an outcome measure in clinical trials to evaluate new pain treatments when it is desirable to evaluate success in individual dogs rather than overall mean or median scores in a test population .


Two once-daily long-acting muscarinic antagonists ( LAMAs ) are currently available for the treatment of chronic obstructive pulmonary disease ( COPD ) - tiotropium and glycopyrronium .


Previous studies have compared glycopyrronium with open-label tiotropium .


In the GLOW@ study , we compare glycopyrronium with blinded tiotropium .


In this blinded , double-dummy , parallel group , @-week study , patients with moderate-to-severe COPD were randomized @:@ to glycopyrronium @ g once daily or tiotropium @ g once daily .


The primary objective was to demonstrate the non-inferiority of glycopyrronium versus blinded tiotropium with respect to trough forced expiratory volume in @ second ( FEV@ ) following @ weeks of treatment ( non-inferiority margin : -@ mL ) .


Secondary objectives were to evaluate glycopyrronium versus tiotropium for other spirometric outcomes , breathlessness ( Transition Dyspnea Index ; TDI ) , health status ( St George 's Respiratory Questionnaire ; SGRQ ) , daily rescue medication use , COPD exacerbations and COPD symptoms over @ weeks of treatment .


@ patients were randomized ( glycopyrronium : @ ; tiotropium : @ ) ; @ % ( @ patients ) completed the study .


Least squares mean trough FEV@ for both glycopyrronium and tiotropium was @ L at Week @ , meeting the criterion for non-inferiority ( mean treatment difference : @ mL , @ % CI : -@ , @ mL ) .


Glycopyrronium demonstrated rapid bronchodilation following first dose on Day @ , with significantly higher FEV@ at all time points from @-@ h post-dose versus tiotropium ( all p < @ ) .


FEV@ area under the curve from @-@ h ( AUC@-@h ) post-dose with glycopyrronium was significantly superior to tiotropium on Day @ ( p < @ ) and was comparable to tiotropium at Week @ .


Glycopyrronium demonstrated comparable improvements to tiotropium in TDI focal score , SGRQ total score , rescue medication use and the rate of COPD exacerbations ( all p = not significant ) .


Patients on glycopyrronium also had a significantly lower total COPD symptom score versus patients on tiotropium after @ weeks ( p = @ ) .


Adverse events were reported by a similar percentage of patients receiving glycopyrronium ( @ % ) and tiotropium ( @ % ) .


In patients with moderate-to-severe COPD , @-week blinded treatment with once-daily glycopyrronium @ g or tiotropium @ g , provided similar efficacy and safety , with glycopyrronium having a faster onset of action on Day @ versus tiotropium .


To investigate the potential of lipoprotein-associated phospholipase A@ inhibition as a novel mechanism to reduce edema and improve vision in center-involved diabetic macular edema ( DME ) .


Prospective , multicenter , randomized , double-masked , placebo-controlled phase IIa study .


Fifty-four center-involved DME patients randomized @:@ to receive darapladib ( n = @ ) or placebo ( n = @ ) .


Darapladib @ mg or placebo monotherapy was administered orally once daily for @ months , and patients were followed up monthly for @ months .


Mean change from baseline in best-corrected visual acuity ( BCVA ) and the center subfield and center point of the study eye at month @ as determined by spectral-domain optical coherence tomography .


Five patients in the study received intravitreal anti-vascular endothelial growth factor rescue therapy before the day @ assessment , @ of @ ( @ % ) in the darapladib arm and @ of @ ( @ % ) in the placebo arm .


Administration of @ mg darapladib for @ months resulted in statistically significant mean improvements , from baseline to month @ , in BCVA of @ Early Treatment Diabetic Retinopathy Study ( ETDRS ) letters ( @ % confidence interval -LSB- CI -RSB- , @-@ @ ) and of @ m in central subfield thickness ( @ % CI , -@ to -@ ) in the study eyes .


An increase in BCVA of @ ETDRS letters ( @ % CI , -@ to @ ) and a decrease in center subfield thickness of @ m ( @ % CI , -@ to @ ) for the placebo group were not significant .


No ocular severe adverse events ( SAEs ) or SAEs considered related to darapladib were reported .


One SAE of myocardial infarction , not considered related to darapladib , was reported , and @ SAE of severe diarrhea was reported in a placebo patient , subsequently withdrawn from the study .


Study eye ocular adverse events ( AEs ) and nonocular AEs were similar between treatment groups .


Once-daily oral darapladib administered for @ months demonstrated modest improvements in vision and macular edema that warrant additional investigation of this novel lipoprotein-associated phospholipase A@ inhibitory mechanism for the treatment of DME .


To characterize retinal metabolism during normoxia and hyperoxia in healthy subjects .


Forty-six healthy subjects were included in the present study , and data of @ subjects could be evaluated .


Retinal vessel diameters , as well as oxygen saturation in arteries and veins , were measured using the Dynamic Vessel Analyzer .


In addition , retinal venous blood velocity was measured using bidirectional laser Doppler velocimetry , retinal blood flow was calculated , and oxygen and carbon dioxide partial pressures were measured from arterialized capillary blood from the earlobe .


Measurements were done during normoxia and during @ % oxygen breathing .


Systemic hyperoxia caused a significant decrease in retinal venous diameter ( -@ % @ % ) and arterial diameter ( -@ % @ % ) , in retinal blood velocity ( -@ % @ % ) , and in retinal blood flow ( -@ % @ % ) ( P < @ for all ) .


Oxygen saturation increased in retinal arteries ( +@ % @ % ) and in retinal veins ( +@ % @ % ) , but the arteriovenous oxygen content difference significantly decreased ( -@ % @ % ) ( P < @ for all ) .


Blood oxygen tension in arterialized blood showed a pronounced increase from @ @ to @ @ mm Hg ( P < @ ) .


Calculated oxygen extraction in the eye decreased by as much as @ % @ % ( P < @ ) .


Our data are compatible with the hypothesis that during @ % oxygen breathing a large amount of oxygen , consumed by the inner retina , comes from the choroid , which is supported by previous animal data .


Interpretation of oxygen saturation data in retinal arteries and veins without quantifying blood flow is difficult .


( ClinicalTrials.gov number , NCT@ . )


Young people in sub-Saharan Africa are affected by the HIV pandemic to a greater extent than young people elsewhere and effective HIV-preventive intervention programmes are urgently needed .


The present article presents the rationale behind an EU-funded research project ( PREPARE ) examining effects of community-based ( school delivered ) interventions conducted in four sites in sub-Saharan Africa .


One intervention focuses on changing beliefs and cognitions related to sexual practices ( Mankweng , Limpopo , South Africa ) .


Another promotes improved parent-offspring communication on sexuality ( Kampala , Uganda ) .


Two further interventions are more comprehensive aiming to promote healthy sexual practices .


One of these ( Western Cape , South Africa ) also aims to reduce intimate partner violence while the other ( Dar es Salaam , Tanzania ) utilises school-based peer education .


A modified Intervention Mapping approach is used to develop all programmes .


Cluster randomised controlled trials of programmes delivered to school students aged @-@ will be conducted in each study site .


Schools will be randomly allocated ( after matching or stratification ) to intervention and delayed intervention arms .


Baseline surveys at each site are followed by interventions and then by one ( Kampala and Limpopo ) or two ( Western Cape and Dar es Salaam ) post-intervention data collections .


Questionnaires include questions common for all sites and are partly based on a set of social cognition models previously applied to the study of HIV-preventive behaviours .


Data from all sites will be merged in order to compare prevalence and associations across sites on core variables .


Power is set to @ or higher and significance level to @ or lower in order to detect intervention effects .


Intraclass correlations will be estimated from previous surveys carried out at each site .


We expect PREPARE interventions to have an impact on hypothesized determinants of risky sexual behaviour and in Western Cape and Dar es Salaam to change sexual practices .


Results from PREPARE will ( i ) identify modifiable cognitions and social processes related to risky sexual behaviour and ( ii ) identify promising intervention approaches among young adolescents in sub-Saharan cultures and contexts .


Though topical corticosteroids ( TC ) are used for treating atopic dermatitis ( AD ) as a standard , there exist several problems including topical steroid addiction ( TSA ) or Red skin syndrome .


Moreover , the number of patients , who refrain from using TC because of steroid-phobia , is increasing .


Recently , topical PPAR alpha ligand application has been reported to improve experimental allergic dermatitis .


The purpose of this study was to investigate the short-term efficacy and safety of topical clofibrate , one of PPAR alpha ligand , in such steroid-phobic patients with AD .


This study was conducted as a double-blind design to investigate the effects of random administration of topical clofibrate and base ( placebo ) on skin manifestation and blood parameters of patients for @ weeks .


Severity was digitized using severity scoring systems for atopic dermatitis by the Japanese Dermatological Association ( SSS-JDA ) before and after two weeks .


Subjective severity of patients was evaluated using visual analog scale ( Pt-VAS ) .


Serum thymus and activation-regulated chemokine ( TARC ) and immunoglobulin E ( IgE ) were also investigated .


Twenty patients were enrolled , and @ of @ patients completed the study .


In @ patients , the value of severity score using SSS-JDA was decreased significantly after administration of topical clofibrate ( P = @ ) .


Subjective evaluation using Pt-VAS ( P = @ ) and serum TARC levels ( P = @ ) were also significantly decreased after two weeks of topical clofibrate .


There was not a significant difference in serum IgE levels .


No adverse effect was observed .


Topical clofibrate is useful for patients with AD especially who are reluctant to use topical steroids .


To evaluate the effects of single doses of gabapentin @ and @ mg on polysomnographic ( PSG ) and participant-reported sleep measures in a @-h phase advance insomnia model .


Adults reporting occasional disturbed sleep received gabapentin @ mg ( n = @ ) , @ mg ( n = @ ) , or placebo ( n = @ ) @ min prior to bedtime and were in bed from @:@ to @:@ , @ h before their habitual bedtime .


Sleep was assessed by PSG , post-sleep questionnaire , and the Karolinska Sleep Diary ( KSD ) .


Next-day residual effects ( Digit Symbol Substitution Test -LSB- DSST -RSB- and Stanford Sleepiness Scale -LSB- SSS -RSB- ) and tolerability were assessed .


Demographics were comparable among groups .


Among PSG endpoints , wake after sleep onset ( primary endpoint ) ( @ -LSB- placebo -RSB- , @ -LSB- @ mg -RSB- , and @ -LSB- @ mg -RSB- min ) was significantly lower and total sleep time ( TST ) ( @ , @ , and @ min ) significantly greater in both gabapentin groups versus placebo .


Latency to persistent sleep was not significantly different among groups .


Percent slow wave sleep ( @ % , @ % , and @ % , respectively ) was significantly greater and percent stage @ ( @ % , @ % , and @ % , respectively ) significantly lower relative to placebo .


Gabapentin was associated with significantly higher values of KSD Sleep Quality Index and reported TST versus placebo ; no other reported outcomes were significant .


Neither gabapentin dose produced evidence of next-day residual effects as measured by DSST and SSS .


Adverse events were infrequent ( < @ % ) .


Participants with occasional disturbed sleep treated with gabapentin showed significantly longer sleep duration and greater depth ( versus placebo ) in response to a phase advance manipulation known to disrupt sleep maintenance .


The aim of this study is to evaluate the clinical efficacy of short-term psychodynamic psychotherapy ( STPP ) in comparison with treatment as usual ( TAU ) in treatment of patients suffering from anxiety and depressive disorders .


Sixty patients were recruited from the Psychotherapy Service , University of Milan , Department of Psychiatry , at Milan 's IRCCS Foundation Ca ' Granda , Ospedale Maggiore Policlinico with the diagnosis of depressive or anxiety disorders according to DSM-IV-TR criteria .


These subjects were randomly assigned in a @:@ ratio to an intervention group ( STPP ) or control group ( TAU ) for @ months ( T@ ) .


Each patient was clinically evaluated at the moment of recruitment ( T@ ) and after @ months using a battery composed of these scales : Clinical Global Impression Scale ( CGI ) , Symptom Checklist-@-Revised ( SCL-@-R ) , Inventory of Interpersonal Problems ( IIP ) .


Statistical analysis highlighted significant improvements ( p < @ ) for the group treated with STPP in every clinical scale .


Instead control group revealed significant changes ( p < @ ) only for SCL-@ scale scores .


We noticed a clinical improvement in both groups without particular differences , but the IIP scores went through a significant higher enhancement only in STPP group .


Our results suggest that STPP is so effective as TAU in treatment of anxiety and depressive disorders .


Moreover STPP leads to a better recover of relational functioning .


Carotid artery stenting ( CAS ) is a worldwide diffuse intervention , but may be associated with distal plaque component embolization , and sometimes major and minor stroke .


Statin use has been demonstrated to reduce atherosclerotic plaque burden , but its effect in reducing distal embolization during carotid stenting has not yet been well validated .


With the Rosuvastatin Pretreatment to Reduce Embolization during Carotid Artery Stenting trial , we aim to discover if a pretreatement with high doses of rosuvastatin in dyslipidemic patients is able to reduce periprocedural cerebral ischemic complications following carotid stenting .


This is a phase III prospective , randomized controlled trial .


All consecutive patients with asymptomatic carotid stenosis at least @ % will be randomized to a @-week rosuvastatin treatment followed by carotid stenting , and to direct carotid stenting .


Carotid stenting will be performed following common practice with distal or proximal embolic protection .


The primary efficacy end point of the trial will be the prevalence of ` relevant ' embolization during CAS , as a surrogate end point for cerebral ischemic complications .


Other laboratory and clinical data will be registered and patients will be followed up to @ year .


In order to obtain the expected superiority of statin pretreatment on primary end point , a population of @ patients will be enrolled into the study .


In conclusion , with the Rosuvastatin Pretreatment to Reduce Embolization during Carotid Artery Stenting trial , we want to evaluate whether a high dose of rosuvastatin for @ weeks before CAS in asymptomatic patients with severe carotid stenosis is able to reduce the rate of plaque embolization during the procedure , thus suggesting a possible reduction in cerebral ischemic complications .


Among the various factors influencing the success rate , onset time , and duration of peripheral nerve blocks , the role of local anesthetics concentration remains uncertain .


In this prospective , randomized , single-blinded study , we evaluated whether varying the dilution of a fixed dose of mepivacaine solution influenced onset time and duration of sciatic nerve block .


Ninety ASA physical status I to II patients scheduled for foot surgery were randomly allocated to receive a double-injection Labat sciatic nerve block with @ mL mepivacaine @ % ( group concentration I = @ patients ) or @ mL of mepivacaine @ % ( group volume II = @ patients ) .


The nerve stimulator was initially set at @ Hz , @ millisecond , @ mA .


The total amount of local anesthetic ( @ mg ) was kept constant and equally divided between the peroneal and tibial nerves .


All patients also received an ultrasound-guided popliteal sciatic nerve catheter for postoperative analgesia .


Times to readiness for surgery , performance , and offset of local anesthetic were recorded .


Our primary end point was to determine a possible difference in offset time between groups .


Continuous variables were expressed as median ( IQR ) and compared with the Wilcoxon-Mann-Whitney U test ; WMWodds are reported together with their @ % confidence interval .


The overall success rate of sciatic nerve block was @ % .


Time of performance was shorter in group I , @ seconds ( @-@ seconds ) , than that in group II , @ seconds ( @-@ seconds ) ( P = @ ; WMWodds @ -LSB- @-@ @ -RSB- ) .


The onset time of sensory and motor sciatic nerve block was @ minutes ( @-@ minutes ) in group I and @ minutes ( @-@ minutes ) in group II ( P = @ ; WMWodds @ -LSB- @-@ @ -RSB- ) , while the duration of sensory block was @ minutes ( @-@ minutes ) in group I , and @ minutes ( @-@ minutes ) in group II respectively ( P = @ ; WMWodds @ -LSB- @-@ @ -RSB- ) .


We found no evidence that varying volume and concentration while maintaining a fixed total dose of mepivacaine alters the onset time and duration of double-injection sciatic nerve block .


Considering our WMWodds results , possible differences in onset time and duration comparable to differences in the performance time between groups can not be excluded .


To investigate the effects of Thai traditional massage ( TTM ) on pressure pain threshold ( PPT ) and headache intensity in patients with chronic tension-type and migraine headaches .


Randomized controlled trial of TTM compared with the sham ultrasound ( nine sessions each ) during a @-week period .


Seventy-two participants who had had a headache diagnosis for at least @ months before the experiment was recruited .


After the treatment and at @ and @ weeks of follow-up , the TTM group showed a significant increase in PPT ( p < @ ) compared with the sham ultrasound group .


PPT values at baseline , after @ weeks of treatment , and at @ - and @-week follow-up for the TTM group were @ @ , @ @ , @ @ , and @ @ pounds/cm ( @ ) , respectively ; values in the sham ultrasound group were @ @ , @ @ , @ @ and @ @ pounds/cm ( @ ) .


In both groups , headache intensity decreased significantly ( p < @ ) at every end point of the outcome measures , and there were no differences between the groups ( p > @ ) .


TTM could increase PPT and reduce headache intensity , suggesting that this is a possible alternative treatment for chronic headaches .


To evaluate the usefulness of capnography for early detection of respiratory depression during sedoanalgesia procedures in the pediatric emergency department .


To assess whether the administration of oxygen during the procedure can modify monitored parameters , thus delaying detection of respiratory depression .


A prospective randomized study was performed on children between @ year and @ years who underwent sedoanalgesia to perform diagnostic or therapeutic procedures .


They were randomized into two groups ( with or without supplemental oxygen ) .


All patients were monitored by visual inspection , pulse-oximetry and non-invasive capnography .


Monitoring was initiated prior to drug administration and continued until complete recovery of baseline .


The main study variable was respiratory depression defined as apnea , hypoventilation or oxygen desaturation .


Twenty patients were included .


Eleven patients were randomized in the supplemental oxygen group .


This study showed a statistically significant elevation of EtCO@ levels at @ , @ and @min , compared with baseline .


No significant change in the SatO@ mean was detected .


No statistically significant differences were identified when comparing etCO@ mean and SatO@ mean in both groups .


Two cases of respiratory depression were detected early by capnography .


There was a statistically significant correlation between etCO@ at @ and @min , and the degree of sedation achieved .


The inclusion of capnography to routine monitoring for adequate sedation procedures could improve safety .


Oxygen administration does not appear to modify the parameters monitored .


Glycemic index and glycemic load are used to facilitate glucose control among adults with type @ diabetes , with a low glycemic index diet associated with improved glycemic control .


To examine long-term longitudinal associations between changes in glycemic index and glycemic load with glycemic and metabolic control among Latino adults with diabetes .


Secondary data from intervention and comparison participants in the Latinos en Control trial ( @ to @ ) were analyzed .


Data on dietary intake and metabolic characteristics were from low-income , Latino adults ( N = @ ; @ % Puerto Rican ) with type @ diabetes .


The Latinos en Control trial was a randomized clinical trial targeting diabetes self-management among Latinos with type @ diabetes .


Participants were randomized to a group-based behavioral intervention or usual care and followed through @ months .


Outcomes included hemoglobin A@c ( HbA@c ) levels , fasting blood glucose , lipid profiles , anthropometrics , and blood pressure .


Glycemic index and load were analyzed using data from three @-hour dietary recalls conducted at baseline , @ months , and @ months .


Repeated measures regression models were used to examine change in glycemic index and load associated with metabolic characteristics at @ months .


Covariates included sex , age , body mass index , blood pressure , total energy intake , medication use and intensity , physical activity , intervention status ( intervention vs usual care ) , and time .


Increases in glycemic index from baseline to @ months were associated with increased logarithm of HbA@c levels ( = @ ; P = @ ) and waist circumference ( = @ ; P = @ ) over time , but not with fasting glucose , blood lipids , or body mass index .


There was modest evidence to support small , positive associations between glycemic load and HbA@c levels and waist circumference .


Lowering glycemic index is associated with improvements in certain metabolic risk factors among Latinos with diabetes .


Targeting glycemic index may be an important component of dietary strategies for diabetes self-management .


To test whether communicating cardiovascular diseases ( CVD ) risk using a novel risk assessment tool ( Heart Age ) will be able to motivate a population to adopt healthier lifestyles and improve CVD risk profile over the use of a traditional percentage-based tool .


A single-blind randomized intervention study was carried out in a Caucasian population .


A total of @ subjects were randomly allocated to one of three study groups : control ( conventional medical advice was given to the subjects ) , Framingham REGICOR ( @-year percentage risk score , calibrated to Spanish population was given to the subjects ) , or Heart Age group ( Heart Age tool was administered to the subjects ) .


Anthropometrical and metabolic parameters were measured and lifestyle habits were recorded at recruitment and @-months post intervention .


Both the Framingham REGICOR and the Heart Age intervention groups demonstrated significant decreases in their risk scores at post intervention compared to the control group , with the improvement being of a greater magnitude in the Heart Age group .


No differences per gender were observed in the Heart Age group .


Informing patients about their CVD risk expressed as the new Heart Age tool results in a reduction in their CVD risk higher than the one observed when the Framingham REGICOR risk score was used .


Tonsillectomy is one of the most common pediatric surgical procedures performed in the United States .


The postoperative period can be particularly painful , and there is currently no consensus on an optimal analgesic regimen .


The objective of this study was to evaluate efficacy and safety of the single drug tramadol versus codeine/acetaminophen post-tonsillectomy .


Prospective , double-blinded , randomized controlled trial .


Large , Midwestern US pediatric hospital .


Eighty-four children aged @-@ years who underwent a tonsillectomy ( with or without adenoidectomy ) procedure were randomized and @ were included in the analysis .


Group @ received liquid codeine/acetaminophen for @ days post-tonsillectomy ( @ days scheduled , followed by @ days as-needed ) .


Group @ received liquid tramadol for @ days post-tonsillectomy ( @ days scheduled , followed by @ days as-needed ) .


Efficacy and side effects were evaluated using a @-day take-home diary that was completed by parents .


Children in both study arms reported adequate post-tonsillectomy pain management without significant differences between groups in pain scores .


Oversedation was significantly higher on the day of surgery in the codeine/acetaminophen group , and itching was experienced by significantly more children in the tramadol group during the postoperative period .


As part of multimodal analgesia , scheduled plus as-needed tramadol may be considered for children in the postoperative setting due to its analgesic properties , low potential for side effects , and good safety profile .


Thirty-six months of isoniazid preventive therapy ( @IPT ) was superior to @ months of IPT ( @IPT ) in preventing tuberculosis ( TB ) among HIV-infected adults in Botswana .


We assessed the posttrial durability of this benefit .


A @-month double-blind placebo controlled trial ( @:@ randomization ) with recruitment between November @ and July @ and observation until June @ .


One thousand , nine hundred and ninety-five participants were followed in eight public health clinics .


Twenty-four percent had a tuberculin skin test @mm ( TST-positive ) .


A minimum CD@ lymphocyte count was not required for enrolment .


Antiretroviral therapy ( ART ) was provided in accordance with Botswana guidelines ; @ % of participants retained by June @ had initiated ART .


Multivariable analysis using Cox regression analysis included treatment arm , TST status , ART as a time-dependent variable and CD@ cell count at baseline and updated at @ months .


In the posttrial period , @ and @ per @ person-years accumulated , whereas @ and @ % TB incidence rates were observed in the @IPT and @IPT arms , respectively ( P = @ ) .


The crude hazard ratio of TB during the trial and posttrial was @ -LSB- @ % confidence intervals ( CI ) @ , @ -RSB- and @ ( @ % CI @ , @ ) , and when restricted to TST-positive participants was @ ( @ % CI @ , @ ) and @ ( @ % CI @ , @ ) , respectively .


Multivariable analysis showed that ART use was associated with reduced death ( adjusted hazard ratio @ , @ % CI @-@ @ ) but not TB ( @ , @ % CI @-@ @ ) in the posttrial period .


The benefit of @IPT for TB prevention declined posttrial in this cohort .


Adjunctive measures are warranted to prevent TB among HIV-infected persons receiving long-term ART in TB-endemic settings .


To evaluate the short-term efficacy and safety of methoxyflurane for the treatment of acute pain in patients presenting to an emergency department ( ED ) with minor trauma .


STOP !


was a randomised , double-blind , multicentre , placebo-controlled study conducted at six sites in the UK .


A total of @ patients , @ of whom were adolescent patients ( age @-@ years ) , were randomised @:@ to receive either methoxyflurane via a Penthrox inhaler or placebo .


The primary end point of the study was the change in pain intensity as measured using the visual analogue scale ( VAS ) from baseline to @ , @ , @ and @ min after the start of study drug inhalation .


Patients were supplied with one inhaler containing @ mL methoxyflurane or @ mL placebo after enrolment and initial assessments .


Age group ( adolescent/adult ) and baseline VAS score were controlled for in the statistical analyses .


A total of @ patients received methoxyflurane , and @ patients received placebo .


Demographic and baseline characteristics were comparable between the groups .


Methoxyflurane reduced pain severity significantly more than placebo ( p < @ ) at all time points tested , with the greatest estimated treatment effect of -@ mm ( adjusted change from baseline ) seen at @ min after the start of treatment .


Methoxyflurane was well tolerated , with the majority of adverse reactions being mild , transient and in line with anticipated pharmacological action .


The results of this study suggest that methoxyflurane administered via the Penthrox inhaler is an efficacious , safe , and rapidly acting analgesic .


Research has shown that paranoia may directly build on negative ideas about the self .


Feeling inferior can lead to ideas of vulnerability .


The clinical prediction is that decreasing negative self cognitions will reduce paranoia .


Thirty patients with persistent persecutory delusions were randomised to receive brief CBT in addition to standard care or to standard care ( ISRCTN@ ) .


The six session intervention was designed to decrease negative , and increase positive , self cognitions .


Assessments at baseline , @ weeks ( posttreatment ) and @ weeks were carried out by a rater blind to allocation .


The primary outcomes were posttreatment scores for negative self beliefs and paranoia .


Secondary outcomes were psychological well-being , positive beliefs about the self , persecutory delusions , social comparison , self-esteem , anxiety , and depression .


Trial recruitment and retention were feasible and the intervention highly acceptable to the patients .


All patients provided follow-up data .


Posttreatment there was a small reduction in negative self beliefs ( Cohen 's d = @ ) and a moderate reduction in paranoia ( d = @ ) , but these were not statistically significant .


There were statistically significant improvements in psychological well-being ( d = @ ) , positive beliefs about the self ( d = @ ) , negative social comparison ( d = @ ) , self-esteem ( d = @ ) , and depression ( d = @ ) .


No improvements were maintained .


No adverse events were associated with the intervention .


The intervention produced short-term gains consistent with the prediction that improving cognitions about the self will reduce persecutory delusions .


The improvement in psychological well-being is important in its own right .


We recommend that the different elements of the intervention are tested separately and that the treatment is lengthened .


Tissue oxygenation is a strong predictor of surgical site infection .


Improving tissue oxygenation should thus reduce wound infection risk .


Supplemental inspired oxygen can improve tissue oxygenation , but whether it reduces infection risk remains controversial .


Low-dose dexamethasone is often given to reduce the risk of postoperative nausea and vomiting , but steroid-induced immunosuppression can increase infection risk .


We therefore tested the hypotheses that supplemental perioperative oxygen reduces infection risk and that dexamethasone increases it .


Using a factorial design , patients having colorectal resections expected to last @ h were randomly assigned to @ % ( n = @ ) or @ % ( n = @ ) inspired oxygen during and for @ h after surgery , and to @ mg intraoperative dexamethasone ( n = @ ) or placebo ( n = @ ) .


Physicians blinded to group assignments evaluated wounds postoperatively , using US Centers for Disease Control criteria .


Subject and surgical characteristics were similar among study groups .


Surgical site infection incidence was similar among groups : @ % oxygen @ % , @ % oxygen @ % ( P = @ ) ; dexamethasone @ % , placebo @ % , ( P = @ ) .


Supplemental oxygen did not reduce surgical site infection risk .


The preponderance of clinical evidence suggests that administration of @ % supplemental inspired oxygen does not reduce infection risk .


We did not observe an increased risk of surgical site infection with the use of a single low dose of dexamethasone , indicating that it can be used for nausea and vomiting prophylaxis without promoting wound infections .


Mental practice using motor imagery of limb movement may facilitate motor recovery in persons who have experienced cerebrovascular accident ( CVA ) .


However , the lack of a feedback mechanism that can monitor the quality of the motor imagery affects patients ' engagement and motivation to participate in the mental practice training program .


This study investigates the effect of novel real-time motor imagery-associated cortical activity feedback on motor imagery-based mental practice training .


Ten healthy volunteers were randomly assigned into intervention and control groups .


Both groups participated in a five-visit motor imagery-based mental practice training program managed over a period of two months .


The intervention group received mental practice training with real-time feedback of movement-associated cortical activity-beta band ( @-@ Hz ) event-related desynchronization ( ERD ) in electroencephalography ( EEG ) , using a novel custom-made brain-computer interface ( BCI ) system .


The control group received the mental practice training program without EEG cortical feedback .


Motor excitability was assessed by measuring the frequency power magnitude of the EEG rhythmic activity associated with physical execution of wrist extension before and after the motor imagery-based mental practice training .


The EEG frequency power magnitude associated with the physical execution of wrist extension was significantly lower ( i.e. more desynchronized ) after the mental practice training in the intervention group that received real-time cortical feedback ( P < @ ) , whereas no significant difference in EEG frequency power magnitude associated with the physical execution of wrist extension was observed before and after mental practice training in the control group who did not receive feedback .


The mental practice training program with motor imagery-associated cortical feedback facilitated motor excitability during the production of voluntary motor control .


Motor imagery-based mental practice training with movement-associated cortical activity feedback may provide an effective strategy to facilitate motor recovery in brain injury patients , particularly during the early rehabilitation stage when full participation in physical and occupational therapy programs may not be possible due to excessive motor weakness .


To assess whether buccal misoprostol is effective for the treatment of intrauterine fetal death .


This double-blind randomized trial was conducted at five tertiary-level hospitals in the United States and Vietnam .


One hundred fifty-three women with an intrauterine fetal death at @-@ weeks of pregnancy received either @ mcg buccal misoprostol or @ mcg buccal misoprostol every @ h for a maximum of @ doses .


The main outcome measure was the fetal-placental delivery rate within @ hours of prostaglandin commencement without any additional intervention .


Most of the women ( @/@ ) were recruited at the study site in Vietnam .


Expulsion of both fetus and placenta within @ hours of prostaglandin commencement without any additional interventions occurred in @ % ( @/@ ) of women receiving misoprostol @ mcg and @ % ( @/@ ) of women receiving misoprostol @ mcg .


The @ mcg dose was significantly more effective than the @ mcg dose at expelling the fetus and placenta within @ h -LSB- RR @ ( @ % CI : @-@ @ ; p = @ ) -RSB- .


The mean time to expulsion was significantly shorter using the @ mcg dose ( @ h ) than the @ mcg dose ( @ h ) ( p = @ ) .


Most women in both groups found the procedure satisfactory or very satisfactory ( @ mcg : @ % ( @/@ ) ; @ mcg : @ % ( @/@ ) -LSB- RR @ ( @ % CI : @-@ @ ) -RSB- .


Buccal misoprostol is an effective method for medical induction of labor after intrauterine fetal demise .


A @ mcg dose is significantly more effective than @ mcg for evacuating the uterus within @h .


The treatment is highly acceptable to women .


Administration of @ mcg buccal misoprostol every six hours is an effective and acceptable method to effect the delivery of a demised fetus at @-@ weeks that can be feasibly implemented in a wide variety of settings .


Obesity and obstructive sleep apnea tend to coexist and are associated with inflammation , insulin resistance , dyslipidemia , and high blood pressure , but their causal relation to these abnormalities is unclear .


We randomly assigned @ patients with obesity , moderate-to-severe obstructive sleep apnea , and serum levels of C-reactive protein ( CRP ) greater than @ mg per liter to receive treatment with continuous positive airway pressure ( CPAP ) , a weight-loss intervention , or CPAP plus a weight-loss intervention for @ weeks .


We assessed the incremental effect of the combined interventions over each one alone on the CRP level ( the primary end point ) , insulin sensitivity , lipid levels , and blood pressure .


Among the @ participants for whom there were follow-up data , those assigned to weight loss only and those assigned to the combined interventions had reductions in CRP levels , insulin resistance , and serum triglyceride levels .


None of these changes were observed in the group receiving CPAP alone .


Blood pressure was reduced in all three groups .


No significant incremental effect on CRP levels was found for the combined interventions as compared with either weight loss or CPAP alone .


Reductions in insulin resistance and serum triglyceride levels were greater in the combined-intervention group than in the group receiving CPAP only , but there were no significant differences in these values between the combined-intervention group and the weight-loss group .


In per-protocol analyses , which included @ participants who met prespecified criteria for adherence , the combined interventions resulted in a larger reduction in systolic blood pressure and mean arterial pressure than did either CPAP or weight loss alone .


In adults with obesity and obstructive sleep apnea , CPAP combined with a weight-loss intervention did not reduce CRP levels more than either intervention alone .


In secondary analyses , weight loss provided an incremental reduction in insulin resistance and serum triglyceride levels when combined with CPAP .


In addition , adherence to a regimen of weight loss and CPAP may result in incremental reductions in blood pressure as compared with either intervention alone .


( Funded by the National Heart , Lung , and Blood Institute ; ClinicalTrials.gov number , NCT@ . )


Circumcision and lower human papillomavirus ( HPV ) viral loads in men are possibly associated with a reduced risk of HPV transmission to women .


However , the association between male circumcision and HPV viral load remains unclear .


Swab specimens from the glans and shaft of the penis were collected from men enrolled in a circumcision trial in Kisumu , Kenya .


GP@ + / @ + polymerase chain reaction ( PCR ) was used to identify HPV DNA types .


HPV-@ and HPV-@ loads were measured with a LightCycler real-time PCR and classified as high ( > @ copies/scrape ) or low ( @ copies/scrape ) .


A total of @ men were randomly assigned to undergo immediate circumcision , and @ men were randomly assigned to the control arm ( these individuals were asked to remain uncircumcised until the study ended ) .


The hazard of acquisition of high-viral load infections in the glans was lower in the circumcision arm , compared with the control arm , for HPV-@ ( hazard ratio -LSB- HR -RSB- , @ -LSB- @ % confidence interval -LCB- CI -RCB- , @ -@ -RSB- ) and HPV-@ ( HR , @ -LSB- @ % CI , @ -@ -RSB- ) .


The @-month risk of HPV persistence among men with high-viral load infections in the glans at baseline was lower in the circumcision arm , compared with the control arm , for HPV-@ ( risk ratio -LSB- RR -RSB- , @ -LSB- @ % CI , @ -@ -RSB- ) and HPV-@ ( RR @ -LSB- @ % CI , @ -@ -RSB- ) .


Weaker and less precise results were obtained for shaft samples .


Male circumcision could potentially reduce the risk of HPV transmission to women by reducing the hazard of acquisition , and the risk of persistence of high-HPV viral load infections in the glans in men .


Previous cell-based and animal studies showed mixed tocotrienols are neuroprotective , but the effect is yet to be proven in humans .


Thus , the present study aimed to evaluate the protective activity of mixed tocotrienols in humans with white matter lesions ( WMLs ) .


WMLs are regarded as manifestations of cerebral small vessel disease , reflecting varying degrees of neurodegeneration and tissue damage with potential as a surrogate end point in clinical trials .


A total of @ volunteers aged @ years with cardiovascular risk factors and MRI-confirmed WMLs were randomized to receive @ mg mixed tocotrienols or placebo twice a day for @ years .


The WML volumes were measured from MRI images taken at baseline , @ year , and @ years using a validated software and were compared .


Fasting blood samples were collected for full blood chemistry investigation .


According to per-protocol ( @ volunteers ) and intention-to-treat ( @ volunteers ) analyses , the mean WML volume of the placebo group increased after @ years , whereas that of the tocotrienol-supplemented group remained essentially unchanged .


The mean WML volume change between the @ groups was not significantly different ( P = @ ) at the end of @ year but was significant at the end of @ years for both per-protocol and intention-to-treat analyses ( P = @ and P = @ ) .


No significant difference was observed in the blood chemistry parameters between the @ groups .


Mixed tocotrienols were found to attenuate the progression of WMLs .


Fimasartan is a novel angiotensin II receptor blocker .


Fimasartan is mainly eliminated via biliary excretion , and its urinary elimination is less than @ % .


Based on guidance from the United States Food and Drug Administration , a reduced pharmacokinetic ( PK ) study was conducted to evaluate the effect of renal function on the PK of fimasartan in patients with renal impairment and healthy volunteers .


A single centre , single-dose , open-label , healthy volunteer controlled trial was conducted in patients with renal impairment ( RI ) ( estimated glomerular filtration rate lower than @ mL/min/@ @ m ( @ ) ) and age - , weight - and sex-matched healthy volunteers ( estimated glomerular filtration rate higher than @ mL/min/@ @ m ( @ ) ) .


All participants received a single oral dose of fimasartan @ mg , after which serial blood sampling for PK evaluation was conducted .


Noncompartmental PK analysis of fimasartan was performed .


A mixed-effects model approach was used to identify significant covariates and PK parameters .


Sixteen subjects were enrolled ( @ healthy volunteers and @ RI patients ) .


The maximum plasma concentrations and areas under the plasma concentration curves of the RI patients were higher than those of the healthy volunteers , with geometric mean ratios of @ and @ , respectively .


The relative bioavailability of fimasartan from the population PK analysis was @ % higher in the RI patients than in the healthy volunteers .


The increased drug exposure of fimasartan in RI patients was explained by the increased relative bioavailability .


This result can be explained from our knowledge concerning alterations in PK related to renal function .


Milk may stimulate growth acting via insulin-like growth factor-I ( IGF-I ) secretion but the effect in adolescents is less examined .


This study investigates the effect of milk proteins on linear growth , IGF-I , IGF binding protein-@ ( IGFBP-@ ) and IGF-I/IGFBP -@ ratio in overweight adolescents .


The trial included @ overweight adolescents aged @-@ years .


They were randomized to drink @L/day of : skimmed milk , whey , casein or water for @ weeks ; all milk-based drinks contained @ g protein/L .


A subgroup of @ adolescents was examined @ weeks before they were randomized into the groups and started the intervention ( pre-test control group ) .


Examinations included anthropometry , diet registration and blood samples which were analyzed for IGF-I and IGFBP-@ by chemiluminescence methods .


The effects of milk-based drinks on linear growth , IGF-I , IGFBP-@ and IGF-I availability , calculated as the IGF-I/IGFBP -@ ratio , were compared with baseline , the pre-test control group and water .


IGF-I increased with skimmed milk ( P = @ ) and tended to increase with casein ( P = @ ) compared to the pre-test control group .


IGFBP-@ but not IGF-I increased with skimmed milk ( P = @ ) and casein ( P = @ ) compared to water .


There was no difference in height or height Z-score for any of the milk-based test drink groups compared to water or compared to the pre-test control group .


However , height Z-score decreased within the whey group .


Skimmed milk and casein may have a stimulating effect on the IGF-I system whereas there was no positive effect on height in overweight adolescents during this @ week intervention .


Mutations in lipoprotein-associated phospholipase A@ ( Lp-PLA@ ) are related to atherosclerosis .


However , the molecular effects of Lp-PLA@ on atherosclerosis have not been fully investigated .


Therefore , this study attempted to elucidate this issue .


Monocytes were isolated from randomly selected healthy male volunteers according to each Lp-PLA@ genotype ( wild-type Lp-PLA@ -LSB- Lp-PLA@ ( V/V ) -RSB- , the heterozygous V@F mutation -LSB- LpPLA@ ( V/F ) -RSB- and the homozygous V@F mutation -LSB- Lp-PLA@ ( F/F ) -RSB- ) and differentiated into macrophages .


The level of apoptosis in the macrophages following incubation without serum was measured using the annexin V/propidium iodide double staining method , and the underlying mechanisms were further examined using a culture cell line .


The average plasma Lp-PLA@ concentration -LSB- Lp-PLA@ ( V/V ) : @ ng/mL , Lp-PLA@ ( V/F ) : @ ng/mL , Lp-PLA@ ( F/F ) : @ ng/mL -RSB- and activity -LSB- Lp-PLA@ ( V/V ) : @ nmol/min/mL , LpPLA@ ( V/F ) : @ nmol/min/mL , Lp-PLA@ ( F/F ) : @ nmol/min/mL -RSB- were significantly different between each genotype , although the basic clinical characteristics were similar .


The percentage of apoptotic cells was significantly higher among the Lp-PLA@ ( F/F ) macrophages compared with that observed in the Lp-PLA@ ( V/V ) macrophages .


This induction of apoptosis was independent of the actions of acetylated low-density lipoproteins .


In addition , the transfection of the expression plasmid of V@F mutant Lp-PLA@ into Cos-@ cells or monocyte/macrophage-like U@ cells promoted apoptosis .


The knockdown of Lp-PLA@ also increased the number of apoptotic cells .


Among the cells expressing mutant Lp-PLA@ , the caspase-@ activity was increased , while the activated Akt level was decreased .


The V@F mutation of Lp-PLA@ positively regulates the induction of apoptosis in macrophages and Cos-@ cells .


An increase in the caspase-@ activity and a reduction in the activated Akt level are likely to be involved in this phenomenon .


Female libido is multifactorial and complex .


Declining estrogen levels in postmenopausal women affects vaginal function .


The aim of this study was to evaluate female sexual function after using topical estrogen , testosterone , or polyacrylic acid as vaginal lubricants with K-Y jelly as a placebo lubricant .


This was a randomized controlled clinical trial on @ postmenopausal women between @ and @ years of age with follow-up at the Menopause Clinic of the CAISM Unicamp .


The women were randomized to treatment with topical vaginal estrogen , testosterone , polyacrylic acid , or oil lubricant alone , three times a week for a period of @ weeks from November @ to January @ .


We used the Female Sexual Function Index ( FSFI ) to assess changes in sexual response at baseline , and after @ and @ weeks .


After @ weeks of treatment , polyacrylic acid and topical testosterone produced improvements in the FSFI domains of sexual desire , lubrication , satisfaction , reduced pain during intercourse , and total score compared with lubricant alone .


Treatment with topical estrogen in comparison with lubricant alone showed an improvement in the FSFI field of desire .


The intragroup analysis over the time of the treatment showed improvements in the fields of desire , lubrication , and reduced pain for polyacrylic acid , testosterone , and estrogen .


Furthermore , women who used testosterone showed improvements over time in the fields of arousal , orgasm , and satisfaction .


Treatment of postmenopausal women with symptoms of vaginal atrophy with polyacrylic acid , testosterone , and estrogen for @ weeks produced improvements in self-reported female sexual function when compared with a placebo lubricant .


The rate of falls in community dwelling older people with cognitive impairment ( CI ) is twice that of a cognitively intact population , with almost two thirds of people with CI falling annually .


Studies indicate that exercise involving balance and/or a home hazard reduction program are effective in preventing falls in cognitively intact older people .


However the potential benefit of these interventions in reducing falls in people with CI has not been established.This randomised controlled trial will determine whether a tailored exercise and home hazard reduction program can reduce the rate of falls in community dwelling older people with CI .


We will determine whether the intervention has beneficial effects on a range of physical and psychological outcome measures as well as quality of life of participants and their carers .


A health economic analysis examining the cost and potential benefits of the program will also be undertaken .


Three hundred and sixty people aged @years or older living in the community with CI will be recruited to participate in the trial .